AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED® or RhodoLED® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

{ "type": "p", "children": [], "text": "AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED® or RhodoLED® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp." }

AMELUZ, in conjunction with lesion preparation, is only to be administered by a health care provider.

AMELUZ is for topical use only. Not for ophthalmic, oral, or intravaginal use.

Treat single lesions or an entire field affected by multiple lesions with AMELUZ, in combination with red light photodynamic therapy (PDT). PDT requires administration of both AMELUZ and BF-RhodoLED or RhodoLED XL light.

Refer to BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions. Adhere to all safety instructions for both patient and medical personnel while conducting the PDT.

Apply an approximately 1-mm thick layer of AMELUZ to skin lesion(s). Cover individual lesions or the entire AK-field with AMELUZ. Include approximately 5 mm of the surrounding skin. Do not exceed an application area of 60 cm2. Do not use more than 6 grams of AMELUZ (3 tubes) at one time.Retreat lesions that have not completely resolved after 3 months after the initial treatment.

PDT is a multi-stage process:

Step 1. Preparation of Lesions

Before applying AMELUZ, carefully wipe all lesions with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin.

Figure 1A: Degreasing the skin

Thereafter, remove any scaling and crusts and gently roughen all lesion surfaces, taking care to avoid bleeding.

Figure 1B: Removal of scales and crusts

Step 2. Application of AMELUZ

Apply AMELUZ using glove protected fingertips or a spatula. Use sufficient amount of gel to cover individual lesions or the entire field:

Do not exceed an application area of 60 cm2 and do not use more than 6 grams of AMELUZ (3 tubes) at one time. The gel can be applied to healthy skin around the lesions. Avoid application near mucous membranes such as the eyes, nostrils, mouth, and ears (keep a distance of 1 cm from these areas). In case of accidental contact with mucous membranes, thoroughly rinse with water [see Warnings and Precautions (5.7)].

Allow the gel to dry for approximately 10 minutes before applying occlusive dressing.

Figure 2: Drug application

Step 3. Occlusion for 3 Hours

Cover the area where the gel has been applied with a light-blocking, occlusive dressing. Following 3 hours of occlusion, remove the dressing and wipe off any remaining gel.

Figure 3: Occlusion

Step 4. Illumination with Red Light

For patient and medical personnel, wear suitable protective eyewear during illumination. Avoid staring directly into the light source [see Warnings and Precautions (5.3)].

Illuminate the treatment area with the BF-RhodoLED or RhodoLED XL lamp immediately after removing occlusion and any remaining gel. BF-RhodoLED and RhodoLED XL lamps are red light sources with a narrow spectrum around 635 nm that deliver a light dose of approximately 37 J/cm2. Calibration by the operator is not needed; the illumination time is calculated automatically. Physical measures such as cooling with an air stream or nebulized water may help reduce pain during illumination.

Either the BF-RhodoLED or RhodoLED XL lamp can be used:

Healthy untreated skin surrounding the AK lesions does not need protection during illumination.

Figure 4A: Illumination with BF-RhodoLED

Figure 4B: Illumination with RhodoLED XL

If for any reason, the lesions cannot be illuminated within 3 hours after AMELUZ application, rinse off the gel with saline and water. For 2 days, protect the lesion sites and surrounding skin from sunlight or prolonged or intense light (e.g., tanning beds, sun lamps).

Topical gel: 10% aminolevulinic acid hydrochloride as a white-to-yellowish gel in 2-gram tubes.

{ "type": "p", "children": [], "text": "Topical gel: 10% aminolevulinic acid hydrochloride as a white-to-yellowish gel in 2-gram tubes." }

AMELUZ is contraindicated in patients with:

{ "type": "p", "children": [], "text": "AMELUZ is contraindicated in patients with:" }

{ "type": "ul", "children": [ "Known hypersensitivity to porphyrins.", "Known hypersensitivity to any of the components of AMELUZ, which includes soybean phosphatidylcholine [see Warnings and Precautions (5.1)].", "Porphyria. AMELUZ use may cause uncontrolled phototoxic effects [see Warnings and Precautions (5.5)].", "Photodermatoses. PDT may worsen the phototoxic or photoallergic reactions [see Warnings and Precautions (5.5)]." ], "text": "" }

Several cases of hypersensitivity were reported during postmarketing use of AMELUZ prior to PDT illumination [see Adverse Reactions (6.2)]. If allergic reactions occur, clean the area of skin where the product was applied and institute appropriate therapy. Inform patients and their caregivers that AMELUZ may cause hypersensitivity, potentially including severe courses (anaphylaxis).

Transient amnestic episodes have been reported during postmarketing use of AMELUZ in combination with photodynamic therapy. Inform patients and their caregivers that AMELUZ in combination with photodynamic therapy may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

BF-RhodoLED or RhodoLED XL lamp may cause eye irritation, glare, or injury. Before operating the lamp, personnel must refer to the user manual for specific warnings, cautions, and instructions. Eye exposure to the BF-RhodoLED or RhodoLED XL light must be prevented. Protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period. Avoid staring directly into the light source.

Eyelid edema and dry eyes have occurred after PDT with AMELUZ. PDT with AMELUZ can cause ophthalmic adverse reactions. Avoid direct contact of AMELUZ with the eyes. Rinse eyes with water in case of accidental contact.

AMELUZ increases photosensitivity. Avoid sunlight, prolonged or intense light (e.g., tanning beds, sun lamps) on lesions and surrounding skin treated with AMELUZ for approximately 48 hours following treatment, whether exposed to illumination or not. Concomitant use of AMELUZ with other known photosensitizing agents may increase the risk of phototoxic reaction to PDT [see Drug Interactions (7)].

AMELUZ has not been tested on patients with inherited or acquired coagulation disorders.

Take special care to avoid bleeding during lesion preparation in such patients [see Dosage and Administration (2.3)]. Any bleeding must be stopped before application of the gel.

AMELUZ can cause mucous membrane irritation. AMELUZ is intended for topical use only. Avoid direct contact of AMELUZ to the mucous membranes. Rinse with water in case of accidental contact.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical program for AMELUZ included three double-blind and placebo-controlled phase 3 trials (Trials 1, 2, and 3), enrolling a total of 299 subjects that were treated with narrow band light. Trial subjects were adults greater than or equal to 49 years of age, and the majority had Fitzpatrick skin type I, II, or III. No subjects had Fitzpatrick skin type V or VI. Approximately 86% of subjects were male, and all subjects were White.

For all three phase 3 trials, the enrolled subjects had mild to moderate AKs (Olsen grade 1 and 2) with 4 to 8 lesions on the face and scalp. Overall, 212 AMELUZ-treated subjects (n=32, n=55, and n=125) and 87 subjects receiving placebo (n=16, n=32, n=39) were illuminated with BF-RhodoLED or similar narrow spectrum lamps. For these trials, the maximal dose was one tube of AMELUZ (2 g) and the size of the application area was up to 20 cm2.

Local skin reactions at the application site were observed in about 99.5% of subjects treated with AMELUZ and narrow spectrum lamps. The most frequent adverse reactions during and after PDT were application site erythema, pain, burning, irritation, edema, pruritus, exfoliation, scab, induration, and vesicles.

Most adverse reactions occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases; in some cases, however, they persisted for 1 to 2 weeks or even longer. Severe pain/burning occurred in up to 30% of subjects. In one case, the adverse reactions required interruption or discontinuation of the illumination.

Table 1 presents the incidence of common (≥1%, <10%) and very common (≥10%) adverse reactions at the application site in randomized, multicenter trials which evaluated a maximal dose of one tube of AMELUZ (2 g) and an application area up to 20 cm2.

<div class="scrollingtable"><table cellpadding="0.5pt" width="874"> <caption> <span>Table 1: Incidence of Adverse Reactions Occurring at ≥1% of the AMELUZ Group and More Frequently than the Vehicle Group in Actinic Keratosis Trials 1, 2, and 3 at the Application Site</span> </caption> <colgroup> <col width="33%"/> <col width="33%"/> <col width="33%"/> </colgroup> <tbody class="Headless"> <tr class="First"> <td class="Botrule Toprule" valign="top"> <p class="First">Adverse reaction</p> </td><td class="Botrule Toprule" valign="top"> <p class="First">Vehicle<br/>n=87</p> </td><td class="Botrule Toprule" valign="top"> <p class="First">AMELUZ<br/>n=212</p> </td> </tr> <tr> <td class="Botrule" valign="top"> <p class="First">Adverse reactions at the<br/>application site</p> </td><td class="Botrule" valign="top"></td><td class="Botrule" valign="top"></td> </tr> <tr class="Last"> <td class="Botrule" valign="top"> <p class="First">Erythema</p> <p>Pain/Burning</p> <p>Irritation</p> <p>Edema</p> <p>Pruritus</p> <p>Exfoliation</p> <p>Scab</p> <p>Induration</p> <p>Vesicles</p> <p>Paresthesia</p> <p>Hyperalgesia</p> <p>Reaction</p> <p>Discomfort</p> <p>Erosion</p> <p>Discharge</p> <p>Bleeding</p> <p>Pustules</p> </td><td class="Botrule" valign="top"> <p class="First">34 (39%)</p> <p>26 (30%)</p> <p>17 (20%)</p> <p>3 (3%)</p> <p>14 (16%)</p> <p>4 (5%)</p> <p>2 (2%)</p> <p>0 (0%)</p> <p>1 (1%)</p> <p>2 (2%)</p> <p>0 (0%)</p> <p>2 (2%)</p> <p>0 (0%)</p> <p>0 (0%)</p> <p>0 (0%)</p> <p>0 (0%)</p> <p>0 (0%)</p> </td><td class="Botrule" valign="top"> <p class="First">195 (92%)</p> <p>195 (92%)</p> <p>153 (72%)</p> <p>75 (35%)</p> <p>72 (34%)</p> <p>41 (19%)</p> <p>41 (19%)</p> <p>26 (12%)</p> <p>25 (12%)</p> <p>18 (9%)</p> <p>13 (6%)</p> <p>8 (4%)</p> <p>7 (3%)</p> <p>6 (3%)</p> <p>4 (2%)</p> <p>3 (1%)</p> <p>3 (1%)</p> </td> </tr> </tbody> </table></div>

Common (≥1%, <10%) adverse reactions not at the application site for AMELUZ maximal dose of one tube (2 g) and application area up to 20 cm2 were headache, skin exfoliation, chills and eyelid edema.

Less common (≥0.1%, <1%) adverse reactions at the application site for AMELUZ maximal dose of one tube (2 g) and application area up to 20 cm2 were hemorrhage and swelling. The adverse reactions not at the application site were blister, feeling hot, pruritus, pyrexia, scab, nervousness, pain, petechiae, rash pustular, skin erosion and ulcer.

In a clinical trial designed to investigate the sensitization potential of aminolevulinic acid with 216 healthy subjects, 13 subjects (6%) developed allergic contact dermatitis after continuous exposure for 21 days with doses of aminolevulinic acid that were higher than doses normally used in the treatment of AK.

In two open label clinical trials to evaluate safety and tolerability, 116 subjects with actinic keratosis (AK) on the face and scalp were treated with three tubes (6 g) of AMELUZ applied to a 60 cm² area. Most adverse reactions observed were consistent with those reported in trials using one tube (2 g) of AMELUZ on a 20 cm² area (see Table 1). Additional reactions which occurred in ≥1% of subjects when three tubes (6 g) of AMELUZ were applied to a 60 cm² area included dry eyes, photosensitivity, and application site discoloration, dryness, papules, and fissures.

The frequencies of certain adverse reactions at the application site in these trials—exfoliation, itching, scabbing, and erosion—were more than 10% higher with the larger dose (three tubes, 6 g) and treatment area (60 cm²) compared to the frequencies observed in the trials for the smaller dose (one tube, 2 g) and area (20 cm²). Severe application site pain was reported by 41% of the subjects treated with three tubes (6 g) on a 60 cm² area. Most cases were reported during PDT illumination. A total of 15% of subjects discontinued illumination due to adverse reactions.

The following adverse reactions have been reported during post-approval use of AMELUZ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissue disorders: allergic dermatitis, application site inflammation, application site discoloration.

Eye disorders: eye irritation, diplopia, ocular hyperemia, photophobia, and blurred vision.

General disorders and administration site conditions: fatigue.

Immune System disorders: hypersensitivity.

Nervous system disorders: dysaesthesia, transient amnestic episodes.

There have been no formal studies of the interaction of AMELUZ with other drugs. It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines may enhance the phototoxic reaction to PDT [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "There have been no formal studies of the interaction of AMELUZ with other drugs. It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines may enhance the phototoxic reaction to PDT [see Warnings and Precautions (5.3)]." }

Risk Summary

There are no available data on AMELUZ use in pregnant women to inform a drug associated risk. Animal reproduction studies were not conducted with aminolevulinic acid. Systemic absorption of aminolevulinic acid in humans is negligible following topical administration of AMELUZ under maximal clinical use conditions [see Clinical Pharmacology (12.3)]. It is not expected that maternal use of AMELUZ will result in fetal exposure to the drug.

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Risk Summary

No data are available regarding the presence of aminolevulinic acid in human milk, the effects of aminolevulinic acid on the breastfed infant or on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the negligible systemic absorption of aminolevulinic acid in humans following topical administration of AMELUZ under maximal clinical use conditions [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AMELUZ and any potential adverse effects on the breastfeeding child from AMELUZ or from the underlying maternal condition.

Safety and effectiveness in pediatric patients below the age of 18 have not been established. AK is not a condition generally seen in the pediatric population.

Of the 384 subjects exposed to AMELUZ in randomized, multicenter clinical trials, 83% (318/384) of the subjects were 65 years old and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% is a non-sterile white-to-yellowish gel. The gel formulation contains a nanoemulsion.

{ "type": "p", "children": [], "text": "AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% is a non-sterile white-to-yellowish gel. The gel formulation contains a nanoemulsion." }

Aminolevulinic acid, a porphyrin precursor, is a white to off-white crystalline solid. It is readily soluble in water, methanol, and dimethylformamide. Its chemical name is 5-amino-4-oxo-pentanoic acid hydrochloride, molecular weight is 167.59 and molecular formula is C5H9NO3·HCl. The structural formula of aminolevulinic acid hydrochloride is represented below:

{ "type": "p", "children": [], "text": "Aminolevulinic acid, a porphyrin precursor, is a white to off-white crystalline solid. It is readily soluble in water, methanol, and dimethylformamide. Its chemical name is 5-amino-4-oxo-pentanoic acid hydrochloride, molecular weight is 167.59 and molecular formula is C5H9NO3·HCl. The structural formula of aminolevulinic acid hydrochloride is represented below:" }

Each gram of AMELUZ contains 100 mg of aminolevulinic acid hydrochloride (equivalent to 78 mg aminolevulinic acid) as the active ingredient and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglycerides, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water.

{ "type": "p", "children": [], "text": "Each gram of AMELUZ contains 100 mg of aminolevulinic acid hydrochloride (equivalent to 78 mg aminolevulinic acid) as the active ingredient and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglycerides, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water." }

Photoactivation following topical application of AMELUZ occurs when aminolevulinic acid (prodrug) is metabolized to protoporphyrin IX (PpIX), a photoactive compound which accumulates in the skin. When exposed to red light of a suitable wavelength and energy, PpIX is activated resulting in an excited state of porphyrin molecules. In the presence of oxygen, reactive oxygen species are formed which causes damage to cellular components, and eventually destroys the cells. AMELUZ photodynamic therapy of AK lesions utilizes photoactivation of topically applied AMELUZ resulting from BF-RhodoLED or RhodoLED XL illumination, which provides a red light of narrow spectrum and a light dose of approximately 37 J/cm2.

The pharmacodynamics of AMELUZ in the treatment of actinic keratosis are unknown.

Aminolevulinic acid acts as a prodrug to the photoactive metabolite protoporphyrin IX (PpIX).

Pharmacokinetics (PK) of aminolevulinic acid and PpIX were evaluated in two trials:

In the first trial, a single dose of one entire tube of AMELUZ (2 grams) was applied under occlusion for 3 hours followed by PDT to a total area of 20 cm2 in 12 adult subjects with mild to moderate AK with at least 10 AK lesions on the face or forehead. The mean ± SD baseline plasma aminolevulinic acid concentration was 20.16 ± 16.53 ng/mL. In most subjects, an up to 2.5-fold increase of aminolevulinic acid plasma concentrations was observed during the first 3 hours after AMELUZ application. The mean ± SD area under the concentration time curve (AUC0-t) and maximum concentration (Cmax) for baseline corrected aminolevulinic acid (n=12) were 142.83 ± 75.50 ng·h/mL and 27.19 ± 20.02 ng/mL, respectively. The median Tmax (time at which Cmax occurred) was 3 hours.

The mean ± SD baseline plasma PpIX concentration was 3.27 ± 2.40 ng/mL (n=12). The majority (about 55%) of the PpIX concentrations were below the limit of quantification (LOQ = 1 ng/mL) and baseline corrected values were negative in all subjects except for one. The baseline corrected AUC0-t and Cmax in the single subject was 0.07 ng·h/mL and 0.29 ng/mL, respectively.

In the second trial, a single dose of three entire tubes of AMELUZ (6 grams) was applied under occlusion for 3 hours followed by PDT to a total area of 60 cm2 in 16 adult subjects with mild to severe AK with at least 12 AK lesions on the face and scalp. The mean ± SD baseline plasma aminolevulinic acid concentration was 13.53 ± 1.58 ng/mL. In most subjects, an up to 2.5-fold increase of aminolevulinic acid plasma concentrations was observed during the first 3 hours after AMELUZ application. The mean ± SD area under the concentration time curve (AUC0-t) and maximum concentration (Cmax) for baseline corrected aminolevulinic acid (n=16) were 134.24 ± 87.97 ng·h/mL and 33.85 ± 21.85 ng/mL, respectively. The median Tmax (time at which Cmax occurred) was 3 hours.The mean ± SD baseline plasma PpIX concentration was 1.93 ± 0.42 ng/mL (n=15). The mean ± SD baseline corrected Cmax of PpIX was 0.67 ± 0.78 ng/mL (n=13) with a median Tmax of 4 hours. The baseline corrected PpIX concentrations in 14 of 15 subjects were < 1 ng/mL.

Long-term studies to evaluate the carcinogenic potential of AMELUZ or aminolevulinic acid have not been performed.

Aminolevulinic acid revealed no evidence of mutagenic or clastogenic potential based on the results of three in vitro genotoxicity tests (Ames assay, HPRT test in V79 cells, and Human lymphocyte chromosomal aberration assay) and one in vivo genotoxicity test (mouse micronucleus assay). These genotoxicity studies were conducted without exposure to light. There is a literature report that indicates that aminolevulinic acid may cause genotoxic effects in the presence and in the absence of activating light. These genotoxic effects are likely caused by the formation of reactive oxygen species.

Animal fertility studies have not been conducted with aminolevulinic acid because of the negligible systemic absorption of aminolevulinic acid in humans following topical administration of AMELUZ under maximal clinical use conditions.

The efficacy and safety of AMELUZ in combination with PDT using a narrow spectrum (red light lamp) source were evaluated in three randomized, multicenter trials (Trials 1, 2, and 3). Trials 2 and 3 were vehicle-controlled and double-blind. Trial 1 was double-blind with respect to vehicle and observer-blind regarding the active comparator arm. All clinical trials included a follow-up assessment after 6 and 12 months.

{ "type": "p", "children": [], "text": "The efficacy and safety of AMELUZ in combination with PDT using a narrow spectrum (red light lamp) source were evaluated in three randomized, multicenter trials (Trials 1, 2, and 3). Trials 2 and 3 were vehicle-controlled and double-blind. Trial 1 was double-blind with respect to vehicle and observer-blind regarding the active comparator arm. All clinical trials included a follow-up assessment after 6 and 12 months." }

In these trials, 212 subjects with 4 to 8 mild to moderate AK lesions on the face/forehead and/or bald scalp were treated with up to one tube (2 grams) of AMELUZ on an application area up to 20 cm² and a narrow band spectrum lamp. Subjects ranged from 49 to 87 years of age (mean 71 years), and 92% had Fitzpatrick skin type I, II, or III. No subjects had Fitzpatrick skin type V or VI. Approximately 86% of subjects were male, and all subjects were White.

{ "type": "p", "children": [], "text": "In these trials, 212 subjects with 4 to 8 mild to moderate AK lesions on the face/forehead and/or bald scalp were treated with up to one tube (2 grams) of AMELUZ on an application area up to 20 cm² and a narrow band spectrum lamp. Subjects ranged from 49 to 87 years of age (mean 71 years), and 92% had Fitzpatrick skin type I, II, or III. No subjects had Fitzpatrick skin type V or VI. Approximately 86% of subjects were male, and all subjects were White." }

All sessions were comprised of lesion preparation to roughen the surface and remove crusts, application of AMELUZ with occlusion for 3 hours, and removal of the residual gel. Subsequently, the entire treatment area was illuminated with a narrow spectrum red light source, a lamp of either 630 nm or 633 nm and a light dose of approximately 37 J/cm2. In Trial 3, illumination was performed with BF-RhodoLED, a red light source with a narrow spectrum around 635 nm and a light dose of approximately 37 J/cm2.

{ "type": "p", "children": [], "text": "All sessions were comprised of lesion preparation to roughen the surface and remove crusts, application of AMELUZ with occlusion for 3 hours, and removal of the residual gel. Subsequently, the entire treatment area was illuminated with a narrow spectrum red light source, a lamp of either 630 nm or 633 nm and a light dose of approximately 37 J/cm2. In Trial 3, illumination was performed with BF-RhodoLED, a red light source with a narrow spectrum around 635 nm and a light dose of approximately 37 J/cm2." }

In all trials, the lesions that were not completely cleared 12 weeks after the initial treatment were treated a second time with an identical regimen. In the trials, 42% (88/212) of subjects needed a second treatment.

{ "type": "p", "children": [], "text": "In all trials, the lesions that were not completely cleared 12 weeks after the initial treatment were treated a second time with an identical regimen. In the trials, 42% (88/212) of subjects needed a second treatment." }

The primary endpoint for all trials was complete clearance 12 weeks after the last PDT. The results of Trials 1, 2 and 3 are presented in Table 2.

{ "type": "p", "children": [], "text": "The primary endpoint for all trials was complete clearance 12 weeks after the last PDT. The results of Trials 1, 2 and 3 are presented in Table 2." }

<div class="scrollingtable"><table cellpadding="0.5pt" width="100%"> <caption> <span>Table 2: Complete Clearance 12 Weeks After the Last Narrow Spectrum PDT in Subjects with Actinic Keratoses in Trials 1, 2 and 3</span> </caption> <colgroup> <col width="43%"/> <col width="29%"/> <col width="29%"/> </colgroup> <tbody class="Headless"> <tr class="First"> <td class="Botrule Toprule" valign="middle"></td><td align="center" class="Botrule Toprule" valign="middle"> <p class="First">AMELUZ</p> </td><td align="center" class="Botrule Toprule" valign="middle">Vehicle</td> </tr> <tr> <td align="center" class="Toprule" valign="middle"> <p class="First">Trial 1</p> </td><td align="center" class="Toprule" valign="middle"> <p class="First">106/125 (85%)</p> </td><td align="center" class="Toprule" valign="middle"> <p class="First">5/39 (13%)</p> </td> </tr> <tr> <td align="center" valign="middle"> <p class="First">Trial 2</p> </td><td align="center" valign="middle"> <p class="First">27/32 (84%)</p> </td><td align="center" valign="middle"> <p class="First">2/16 (13%)</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule" valign="middle"> <p class="First">Trial 3</p> </td><td align="center" class="Botrule" valign="middle"> <p class="First">50/55 (91%)</p> </td><td align="center" class="Botrule" valign="middle"> <p class="First">7/32 (22%)</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"0.5pt\" width=\"100%\">\n<caption>\n<span>Table 2: Complete Clearance 12 Weeks After the Last Narrow Spectrum PDT in Subjects with Actinic Keratoses in Trials 1, 2 and 3</span>\n</caption>\n<colgroup>\n<col width=\"43%\"/>\n<col width=\"29%\"/>\n<col width=\"29%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Toprule\" valign=\"middle\"></td><td align=\"center\" class=\"Botrule Toprule\" valign=\"middle\">\n<p class=\"First\">AMELUZ</p>\n</td><td align=\"center\" class=\"Botrule Toprule\" valign=\"middle\">Vehicle</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Toprule\" valign=\"middle\">\n<p class=\"First\">Trial 1</p>\n</td><td align=\"center\" class=\"Toprule\" valign=\"middle\">\n<p class=\"First\">106/125 (85%)</p>\n</td><td align=\"center\" class=\"Toprule\" valign=\"middle\">\n<p class=\"First\">5/39 (13%)</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" valign=\"middle\">\n<p class=\"First\">Trial 2</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">27/32 (84%)</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">2/16 (13%)</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">Trial 3</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">50/55 (91%)</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"middle\">\n<p class=\"First\">7/32 (22%)</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Subjects who achieved complete clearance at 12 weeks after the last PDT entered a 12-month follow-up period. In the three trials, subjects who received AMELUZ with the narrowband PDT and achieved complete clearance 12 weeks after the last PDT had recurrence rates of 14%, 11%, and 25%, respectively (at 6 months) and 40%, 22%, and 37%, respectively (at 12 months).

{ "type": "p", "children": [], "text": "Subjects who achieved complete clearance at 12 weeks after the last PDT entered a 12-month follow-up period. In the three trials, subjects who received AMELUZ with the narrowband PDT and achieved complete clearance 12 weeks after the last PDT had recurrence rates of 14%, 11%, and 25%, respectively (at 6 months) and 40%, 22%, and 37%, respectively (at 12 months)." }

Recurrence was defined as the percentage of subjects with at least one recurrent lesion during the 6-month or 12-month follow-up period in subjects with completely cleared lesions 12 weeks after the last PDT.

{ "type": "p", "children": [], "text": "Recurrence was defined as the percentage of subjects with at least one recurrent lesion during the 6-month or 12-month follow-up period in subjects with completely cleared lesions 12 weeks after the last PDT." }

AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% is a white-to-yellowish gel. The drug product is supplied in an aluminum tube with a white, high density polyethylene (HDPE) screw cap. Each tube contains 2 g of gel.

{ "type": "p", "children": [], "text": "AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% is a white-to-yellowish gel. The drug product is supplied in an aluminum tube with a white, high density polyethylene (HDPE) screw cap. Each tube contains 2 g of gel." }

NDC 70621-101-01 2 g tube

{ "type": "p", "children": [], "text": "NDC 70621-101-01 2 g tube" }

NDC 70621-101-10 Cardbox containing one 2 g tube

{ "type": "p", "children": [], "text": "NDC 70621-101-10 Cardbox containing one 2 g tube" }

NDC 70621-101-20 Cardbox containing ten 2 g tubes

{ "type": "p", "children": [], "text": "NDC 70621-101-20 Cardbox containing ten 2 g tubes" }

Store AMELUZ in a refrigerator, 2°C – 8°C (36°F – 46°F). Excursions permitted to 15°C – 30°C (59°F – 86°F).

{ "type": "p", "children": [], "text": "Store AMELUZ in a refrigerator, 2°C – 8°C (36°F – 46°F). Excursions permitted to 15°C – 30°C (59°F – 86°F)." }

After opening, AMELUZ can be stored for up to 12 weeks in a refrigerator at 2°C – 8°C (36°F – 46°F) if the tube is tightly closed.

{ "type": "p", "children": [], "text": "After opening, AMELUZ can be stored for up to 12 weeks in a refrigerator at 2°C – 8°C (36°F – 46°F) if the tube is tightly closed." }

Inform patients of the following:

Hypersensitivity has been reported with use of AMELUZ. Inform patients and their caregivers that AMELUZ may cause hypersensitivity potentially including severe courses (anaphylaxis) [see Warnings and Precautions (5.1)].

Transient amnestic episodes have been reported with use of AMELUZ in combination with photodynamic therapy. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed [see Warnings and Precautions (5.2)].

Advise patients that for approximately 48 hours following treatment to avoid exposure to sunlight, and prolonged or intense light on the treated lesion sites and surrounding skin.

Advise patients to avoid certain medications that may enhance the phototoxic reaction to PDT [see Warnings and Precautions (5.5) and Drug Interactions (7)].

Inform patients that treatment with AMELUZ in combination with PDT may result in adverse reactions which include local skin reactions at the application site such as erythema, pain/burning, irritation, edema, pruritus, exfoliation, induration, scab, and vesicles [see Clinical Trial Experience (6.1)].

AMELUZ, BF-RhodoLED and RhodoLED are registered trade marks of Biofrontera Pharma GmbH.

{ "type": "p", "children": [], "text": "AMELUZ, BF-RhodoLED and RhodoLED are registered trade marks of Biofrontera Pharma GmbH." }

PATENT INFO

{ "type": "p", "children": [], "text": "PATENT INFO" }

Patent 11,540,981

{ "type": "p", "children": [], "text": "Patent 11,540,981" }

Distributed by:

{ "type": "p", "children": [], "text": "Distributed by:" }

Biofrontera Inc.

{ "type": "p", "children": [], "text": "Biofrontera Inc." }

120 Presidential Way

{ "type": "p", "children": [], "text": "120 Presidential Way" }

Suite 330

{ "type": "p", "children": [], "text": "Suite 330" }

Woburn, MA 01801

{ "type": "p", "children": [], "text": "Woburn, MA 01801" }

USA

{ "type": "p", "children": [], "text": "USA" }

User Manual

{ "type": "p", "children": [], "text": "\nUser Manual\n" }

Manufacturer: Biofrontera Pharma GmbH Distributor: Biofrontera Inc.

{ "type": "p", "children": [], "text": "\nManufacturer: Biofrontera Pharma GmbH\n\nDistributor: Biofrontera Inc.\n" }

Foreword

{ "type": "p", "children": [], "text": "\n\n\nForeword\n" }

Thank you for choosing the BF-RhodoLED® LED lamp for your photodynamic therapy. BF-RhodoLED® has been developed in accordance with applicable technical standards to provide high energy efficiency as well as constant light emission at the desired wavelength.Your lamp must be installed and maintained by a qualified Biofrontera technician and used only in accordance with the instructions in this manual. You may request the latest printed version covering this model from Biofrontera at any time.Our drug Ameluz® and medical device BF-RhodoLED® have been approved in combination for photodynamic therapy; the only approved use of our lamp is in combination with Ameluz® gel. This user manual provides important BF-RhodoLED® product details, cautions and warnings, and operating instructions. For Ameluz®, please use its US prescribing information. The Ameluz® prescribing information includes information on how to use the gel along with contraindications, warnings and precautions and dosage and administration.

{ "type": "p", "children": [], "text": "Thank you for choosing the BF-RhodoLED® LED lamp for your photodynamic therapy. BF-RhodoLED® has been developed in accordance with applicable technical standards to provide high energy efficiency as well as constant light emission at the desired wavelength.Your lamp must be installed and maintained by a qualified Biofrontera technician and used only in accordance with the instructions in this manual. You may request the latest printed version covering this model from Biofrontera at any time.Our drug Ameluz® and medical device BF-RhodoLED® have been approved in combination for photodynamic therapy; the only approved use of our lamp is in combination with Ameluz® gel. This user manual provides important BF-RhodoLED® product details, cautions and warnings, and operating instructions. For Ameluz®, please use its US prescribing information. The Ameluz® prescribing information includes information on how to use the gel along with contraindications, warnings and precautions and dosage and administration." }

Thorough reading and use of both this user manual and the Ameluz® USPI is required prior to treatment. Our combination Ameluz®/BF-RhodoLED® for photodynamic therapy is only to be used by physicians or healthcare professionals.

{ "type": "p", "children": [], "text": "\nThorough reading and use of both this user manual and the Ameluz® USPI is required prior to treatment.\n\nOur combination Ameluz®/BF-RhodoLED® for photodynamic therapy is only to be used by physicians or healthcare professionals.\n" }

For further questions about Ameluz®, BF-RhodoLED® or the combination therapy please contact your sales representative or Biofrontera (Ameluz-US@biofrontera.com). See contact information below or visit us at http://www.biofrontera.us.com/

{ "type": "p", "children": [], "text": "For further questions about Ameluz®, BF-RhodoLED® or the combination therapy please contact your sales representative or Biofrontera (Ameluz-US@biofrontera.com). See contact information below or visit us at http://www.biofrontera.us.com/" }

<div class="scrollingtable"><table border="1" cellpadding="5" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Underline">Sales representative:</span> </p> <p>Name:</p> <p>Tel.:</p> <p>E-mail:</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Biofrontera Inc</span>.</p> <p></p> <p> <span class="Bold">120 Presidential Way</span> <br/> <span class="Bold">Suite 330</span> <br/> <span class="Bold">Woburn, MA 01801</span> <br/> <span class="Bold">USA</span> <br/> <span class="Bold">Phone: (844) 426-3589</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"5\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Underline\">Sales representative:</span>\n</p>\n<p>Name:</p>\n<p>Tel.:</p>\n<p>E-mail:</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Biofrontera Inc</span>.</p>\n<p></p>\n<p>\n<span class=\"Bold\">120 Presidential Way</span>\n<br/>\n<span class=\"Bold\">Suite 330</span>\n<br/>\n<span class=\"Bold\">Woburn, MA 01801</span>\n<br/>\n<span class=\"Bold\">USA</span>\n<br/>\n<span class=\"Bold\">Phone: (844) 426-3589</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Warranty and Disclaimers Please see the terms and conditions of your contract for this information.

{ "type": "p", "children": [], "text": "\nWarranty and Disclaimers\nPlease see the terms and conditions of your contract for this information." }

Manufacturer Biofrontera Pharma GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany

{ "type": "p", "children": [], "text": "\nManufacturer\nBiofrontera Pharma GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany" }

"AMELUZ, RHODOLED and BF-RhodoLED are registered trademarks of Biofrontera Pharma GmbH.©2024 Biofrontera Pharma GmbH. All rights reserved.”

{ "type": "p", "children": [], "text": "\"AMELUZ, RHODOLED and BF-RhodoLED are registered trademarks of Biofrontera Pharma GmbH.©2024 Biofrontera Pharma GmbH. All rights reserved.”" }

1 Intended Use

{ "type": "p", "children": [], "text": "\n1 Intended Use\n" }

BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® gel for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

{ "type": "p", "children": [], "text": "BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® gel for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp." }

2 BF-RhodoLED® - General Description

{ "type": "p", "children": [], "text": "\n\n2 BF-RhodoLED® - General Description\n" }

BF-RhodoLED® is comprised of three main components, the lamp head, the easily adjustable scissor arm, and the mobile frame with castors for smooth transport. In addition, the lamp has a convenient touchscreen monitor, storage shelf, aids for positioning the lamp head and a variable speed patient fan that can be regulated throughout the treatment.

{ "type": "p", "children": [], "text": "BF-RhodoLED® is comprised of three main components, the lamp head, the easily adjustable scissor arm, and the mobile frame with castors for smooth transport. In addition, the lamp has a convenient touchscreen monitor, storage shelf, aids for positioning the lamp head and a variable speed patient fan that can be regulated throughout the treatment." }

3 Warnings and Precautions

{ "type": "p", "children": [], "text": "\n\n3 Warnings and Precautions\n" }

<div class="scrollingtable"><table cellpadding="5" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td><img alt="Symbol 01" src="/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The BF-RhodoLED<span class="Sup">®</span> has been developed for use in photodynamic therapy in combination with Ameluz® gel (excitation wavelength approx. 635 nm). Any other use or combination of use is prohibited.</td> </tr> <tr> <td><img alt="Symbol 01" src="/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>During PDT side-effects such as application site erythema, pain, irritation, edema, pruritus, exfoliation, scab, induration and vesicles may occur. For further information please see Ameluz<span class="Sup">®</span> USPI chapter 6.</td> </tr> <tr> <td><img alt="Symbol 02" src="/dailymed/image.cfm?name=um-symbol-02.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The user manual must be read carefully prior to using the BF-RhodoLED<span class="Sup">®</span>.</td> </tr> <tr> <td><img alt="Symbol 01" src="/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The BF-RhodoLED<span class="Sup">®</span> may only be used by healthcare professionals who have received adequate training in its use.</td> </tr> <tr> <td><img alt="Symbol 03" src="/dailymed/image.cfm?name=um-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>To avoid eye irritation, glare, or injury, protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period.</td> </tr> <tr> <td><img alt="Symbol 01" src="/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Neither the BF-RhodoLED<span class="Sup">®</span> nor the power supply unit should be exposed to excessive mechanical stress or serviced by unauthorized personnel. Assembly and servicing may only be carried out by Biofrontera qualified professionals.</td> </tr> <tr> <td><img alt="Symbol 04" src="/dailymed/image.cfm?name=um-symbol-04.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td> <p class="First"> <span class="Bold">Risk of trapping fingers! The mobility of the adjustable scissor arm may be obstructed by objects placed in or near slots</span><span class="Bold">!</span> </p> <p>Depending on positioning, the scissor arm slots below each connecting portion of the scissor arm and to the right of the support rail can cause fingers or objects to become trapped. When transporting or adjusting the lamp please ensure that fingers or other objects are <span class="Underline">NOT</span> placed in or near the slots (see <span class="Bold">Figure 1</span>).</p> </td> </tr> <tr> <td><img alt="Symbol 01" src="/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td><span class="Bold">Beware of Tipping!</span> <br/>If the castors are in locked position, the lamp will tip over if exposed to lateral force. Leaning against the device or using it for support is not permitted.<br/>Do not place the lamp on uneven or unstable surfaces.<br/>Do not place heavy objects on the storage shelf (maximum load up to 8 kg) or use for sitting, leaning or pushing, as this can lead to the device tipping over.</td> </tr> <tr> <td><img alt="Symbol 01" src="/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>In order to avoid the risk of electrical shock, the device may only be connected to a power supply with a grounded connection.</td> </tr> <tr> <td><img alt="Symbol 01" src="/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Neither the BF-RhodoLED<span class="Sup">®</span> nor its touchscreen monitor may come into contact with water as this may lead to severe damage or electrical shock (exception: cleaning with a damp cloth).</td> </tr> <tr> <td><img alt="Symbol 05" src="/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td> <p class="First">The plexiglass plate on the lamp head may NOT be touched during or directly after treatment as, in the event of faulty operation, the maximum temperature can reach approx. 73 °C (163.4 °F).</p> </td> </tr> <tr> <td><img alt="Symbol 05" src="/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td> <p class="First">Do not position the lamp so that it is difficult to unplug the power plug of the medical device. The lamp can only be disconnected from the supply grid by pulling the power plug.</p> </td> </tr> <tr> <td><img alt="Symbol 05" src="/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The BF-RhodoLED<span class="Sup">®</span> should be operated and housed indoors in areas with temperatures between 0°C and 40°C (32°F and 104°F), and relative humidity of 10 % to 90 %.</td> </tr> <tr> <td><img alt="Symbol 05" src="/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Medical electronic devices require special precautionary measures with regard to the electro-magnetic compatibility (EMC); to avoid elect-magnetic disturbances, please do not place the device close to other electrical devices.</td> </tr> <tr> <td><img alt="Symbol 05" src="/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>There is a risk of tripping over the power cord or the lamp base. When transporting or when device is not in use, unplug and keep the power cord wound around the star knobs.</td> </tr> <tr> <td><img alt="Symbol 05" src="/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Ensure that the touchscreen monitor is always returned to the fixture intended for this purpose, located on the storage shelf. Storing the touchscreen monitor by hanging it can lead to damage to the spiral cord and the plug fitting.</td> </tr> <tr> <td><img alt="Symbol 05" src="/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The touchscreen monitor should not be exposed to strong external pressure or sharp objects.</td> </tr> <tr> <td><img alt="Symbol 05" src="/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>A person trained in operation of the BF-RhodoLED<span class="Sup">®</span> must always be present during treatment.</td> </tr> <tr class="Last"> <td><img alt="Symbol 05" src="/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td> <br/>The device must be protected against unauthorized use.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"5\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><img alt=\"Symbol 01\" src=\"/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The BF-RhodoLED<span class=\"Sup\">®</span> has been developed for use in photodynamic therapy in combination with Ameluz® gel (excitation wavelength approx. 635 nm). Any other use or combination of use is prohibited.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 01\" src=\"/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>During PDT side-effects such as application site erythema, pain, irritation, edema, pruritus, exfoliation, scab, induration and vesicles may occur. For further information please see Ameluz<span class=\"Sup\">®</span> USPI chapter 6.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 02\" src=\"/dailymed/image.cfm?name=um-symbol-02.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The user manual must be read carefully prior to using the BF-RhodoLED<span class=\"Sup\">®</span>.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 01\" src=\"/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The BF-RhodoLED<span class=\"Sup\">®</span> may only be used by healthcare professionals who have received adequate training in its use.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 03\" src=\"/dailymed/image.cfm?name=um-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>To avoid eye irritation, glare, or injury, protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 01\" src=\"/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Neither the BF-RhodoLED<span class=\"Sup\">®</span> nor the power supply unit should be exposed to excessive mechanical stress or serviced by unauthorized personnel. Assembly and servicing may only be carried out by Biofrontera qualified professionals.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 04\" src=\"/dailymed/image.cfm?name=um-symbol-04.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>\n<p class=\"First\">\n<span class=\"Bold\">Risk of trapping fingers! The mobility of the adjustable scissor arm may be obstructed by objects placed in or near slots</span><span class=\"Bold\">!</span>\n</p>\n<p>Depending on positioning, the scissor arm slots below each connecting portion of the scissor arm and to the right of the support rail can cause fingers or objects to become trapped. When transporting or adjusting the lamp please ensure that fingers or other objects are <span class=\"Underline\">NOT</span> placed in or near the slots (see <span class=\"Bold\">Figure 1</span>).</p>\n</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 01\" src=\"/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td><span class=\"Bold\">Beware of Tipping!</span>\n<br/>If the castors are in locked position, the lamp will tip over if exposed to lateral force. Leaning against the device or using it for support is not permitted.<br/>Do not place the lamp on uneven or unstable surfaces.<br/>Do not place heavy objects on the storage shelf (maximum load up to 8 kg) or use for sitting, leaning or pushing, as this can lead to the device tipping over.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 01\" src=\"/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>In order to avoid the risk of electrical shock, the device may only be connected to a power supply with a grounded connection.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 01\" src=\"/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Neither the BF-RhodoLED<span class=\"Sup\">®</span> nor its touchscreen monitor may come into contact with water as this may lead to severe damage or electrical shock (exception: cleaning with a damp cloth).</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>\n<p class=\"First\">The plexiglass plate on the lamp head may NOT be touched during or directly after treatment as, in the event of faulty operation, the maximum temperature can reach approx. 73 °C (163.4 °F).</p>\n</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>\n<p class=\"First\">Do not position the lamp so that it is difficult to unplug the power plug of the medical device. The lamp can only be disconnected from the supply grid by pulling the power plug.</p>\n</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The BF-RhodoLED<span class=\"Sup\">®</span> should be operated and housed indoors in areas with temperatures between 0°C and 40°C (32°F and 104°F), and relative humidity of 10 % to 90 %.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Medical electronic devices require special precautionary measures with regard to the electro-magnetic compatibility (EMC); to avoid elect-magnetic disturbances, please do not place the device close to other electrical devices.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>There is a risk of tripping over the power cord or the lamp base. When transporting or when device is not in use, unplug and keep the power cord wound around the star knobs.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Ensure that the touchscreen monitor is always returned to the fixture intended for this purpose, located on the storage shelf. Storing the touchscreen monitor by hanging it can lead to damage to the spiral cord and the plug fitting.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The touchscreen monitor should not be exposed to strong external pressure or sharp objects.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>A person trained in operation of the BF-RhodoLED<span class=\"Sup\">®</span> must always be present during treatment.</td>\n</tr>\n<tr class=\"Last\">\n<td><img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>\n<br/>The device must be protected against unauthorized use.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table border="1" cellspacing="2" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td>Both the maintenance and the assembly of the BF-RhodoLED<span class="Sup">®</span> and its components (including the opening of individual components) may only be carried out by authorized personnel. In the event of servicing or assembly being carried out by any other party, Biofrontera assumes no responsibility or liability regarding the safety or use of the device.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellspacing=\"2\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td>Both the maintenance and the assembly of the BF-RhodoLED<span class=\"Sup\">®</span> and its components (including the opening of individual components) may only be carried out by authorized personnel. In the event of servicing or assembly being carried out by any other party, Biofrontera assumes no responsibility or liability regarding the safety or use of the device.</td>\n</tr>\n</tbody>\n</table></div>" }

Figure 1: The scissor arm in parked position. Arrows indicate potential points where fingers can get trapped. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered).

{ "type": "p", "children": [], "text": "\nFigure 1: The scissor arm in parked position. Arrows indicate potential points where fingers can get trapped. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered).\n" }

4 BF-RhodoLED® Technical Description

{ "type": "p", "children": [], "text": "\n4 BF-RhodoLED® Technical Description\n" }

4.1 Light Emitting Diodes (LEDs)

{ "type": "p", "children": [], "text": "\n4.1 Light Emitting Diodes (LEDs)\n" }

The light-field of the BF-RhodoLED® consists of a total of 128 LEDs and lenses (arranged in a rectangle), which emit a uniform, bundled, visible red light with a typical peak wavelength of approximately 635 nm. The half-band width of the lamp is 20 nm.

{ "type": "p", "children": [], "text": "The light-field of the BF-RhodoLED® consists of a total of 128 LEDs and lenses (arranged in a rectangle), which emit a uniform, bundled, visible red light with a typical peak wavelength of approximately 635 nm. The half-band width of the lamp is 20 nm." }

Figure 2: Typical emission spectrum of the LEDs of the BF-RhodoLED®. Insert: Fluorescence excitation spectrum of PPIX in cells 0, 3 and 6 mm below the tissue surface (Moan et al., 1996)

{ "type": "p", "children": [], "text": "\nFigure 2: Typical emission spectrum of the LEDs of the BF-RhodoLED®. Insert: Fluorescence excitation spectrum of PPIX in cells 0, 3 and 6 mm below the tissue surface (Moan et al., 1996)" }

The BF-RhodoLED® LEDs are calibrated so that the skin being treated receives a light dosage of approximately 37 J/cm2 under the following conditions:

{ "type": "p", "children": [], "text": "The BF-RhodoLED® LEDs are calibrated so that the skin being treated receives a light dosage of approximately 37 J/cm2 under the following conditions:" }

{ "type": "ul", "children": [ "Illumination time of 10 minutes", "Treatment distance of 5-8 cm (Optimum 6 cm)" ], "text": "" }

The illumination area of the LED lamp is 8 x 18 cm. As the intensity decreases towards the edge of this area, the effective treatment area is reduced to 6 x 16 cm.

{ "type": "p", "children": [], "text": "The illumination area of the LED lamp is 8 x 18 cm. As the intensity decreases towards the edge of this area, the effective treatment area is reduced to 6 x 16 cm." }

4.2 Lamp Components

{ "type": "p", "children": [], "text": "\n\n4.2 Lamp Components\n" }

The BF-RhodoLED® LED lamp consists of the following components (Figure 3):

{ "type": "p", "children": [], "text": "The BF-RhodoLED® LED lamp consists of the following components (Figure 3):" }

{ "type": "ul", "children": [ "Lamp head with holding bracket", "Scissor arm", "Storage shelf with control unit (touchscreen monitor)", "Mobile frame and lamp base (include support rail, castors and power supply)" ], "text": "" }

Figure 3: BF-RhodoLED® main components. (The appearance of devices from batches 001 to 003 slightly differs.)

{ "type": "p", "children": [], "text": "\nFigure 3: BF-RhodoLED® main components. (The appearance of devices from batches 001 to 003 slightly differs.)\n" }

The swivel range to the left and right of the vertical rail is +/- 24°. The lamp head can be adjusted horizontally and vertically and tilted sideways. The scissor arm with internal gas springs allows seamless adjustment of the lamp head to any position. 5 Eye Protection

{ "type": "p", "children": [], "text": "The swivel range to the left and right of the vertical rail is +/- 24°. The lamp head can be adjusted horizontally and vertically and tilted sideways. The scissor arm with internal gas springs allows seamless adjustment of the lamp head to any position.\n\n\n5 Eye Protection\n" }

In order to avoid eye irritation, glare or injury, protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period. Do not stare into the light source! The operator and other persons present must wear protective glasses with a visible light transmission (VLT) of approximately 10%. The patient must wear eye protection such as disposable eye protection pads or eye caps with an optical density for visible light of 6 or higher. Both options are effective and comfortable for use during treatment. Note: Eyewear is not part of the medical device. Please carefully read any accompanying usage information before using any eye protection.

{ "type": "p", "children": [], "text": "In order to avoid eye irritation, glare or injury, protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period. Do not stare into the light source! The operator and other persons present must wear protective glasses with a visible light transmission (VLT) of approximately 10%. The patient must wear eye protection such as disposable eye protection pads or eye caps with an optical density for visible light of 6 or higher. Both options are effective and comfortable for use during treatment.\nNote: Eyewear is not part of the medical device. Please carefully read any accompanying usage information before using any eye protection." }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td><img alt="Symbol 03" src="/dailymed/image.cfm?name=um-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>In order to avoid eye irritation, glare or injury, protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td><img alt=\"Symbol 03\" src=\"/dailymed/image.cfm?name=um-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>In order to avoid eye irritation, glare or injury, protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period.</td>\n</tr>\n</tbody>\n</table></div>" }

6 BF-RhodoLED® PDT Summarized Step-by-Step Instructions

{ "type": "p", "children": [], "text": "\n\n\n6 BF-RhodoLED® PDT Summarized Step-by-Step Instructions\n" }

These instructions should be used in conjunction with detailed operating instructions below (chapter 7). The section titles and numbers listed next to the instruction refer to the detailed instructions and/or descriptions that correspond with each step. Note: Every user of the BF-RhodoLED® has to be trained in operating the device. The initial training is provided by Biofrontera during set-up of the BF-RhodoLED®. Recurrent training is not mandatory but can be provided by Biofrontera employees. Before treating a patient with Ameluz, please ensure that BF-RhodoLED® is in good working order.

{ "type": "p", "children": [], "text": "These instructions should be used in conjunction with detailed operating instructions below (chapter 7). The section titles and numbers listed next to the instruction refer to the detailed instructions and/or descriptions that correspond with each step.\nNote: Every user of the BF-RhodoLED® has to be trained in operating the device. The initial training is provided by Biofrontera during set-up of the BF-RhodoLED®. Recurrent training is not mandatory but can be provided by Biofrontera employees. Before treating a patient with Ameluz, please ensure that BF-RhodoLED® is in good working order." }

<div class="scrollingtable"><table border="1 px" cellpadding="10" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td valign="top">STEP 1)</td><td valign="top">Plug in lamp.</td> </tr> <tr> <td valign="top">STEP 2)</td><td valign="top">Turn on the lamp and wait for home screen to appear (see chapter 7.3)</td> </tr> <tr> <td valign="top">STEP 3)</td><td valign="top">Check the proper functioning of the BF-RhodoLED<span class="Sup">®</span>.</td> </tr> <tr> <td valign="top">STEP 4)</td><td valign="top">Treat the affected skin area: Application, incubation and removal of the topical medication following the USPI of Ameluz<span class="Sup">®</span>.</td> </tr> <tr> <td valign="top">STEP 5)</td><td valign="top">Position patient comfortably and place protective eyewear on patient (see chapter 5).</td> </tr> <tr> <td valign="top">STEP 6)</td><td valign="top">Position the lamp and adjust the lamp head over the skin area to be treated (distance 5-8 cm) (see chapter 7.5.1).</td> </tr> <tr> <td valign="top">STEP 7)</td><td valign="top">Put on protective eyewear and make sure anyone remaining in the treatment room also wears protective eyewear (see chapter 5).</td> </tr> <tr> <td valign="top">STEP 8)</td><td valign="top">Start treatment by pressing "Treatment" on the home screen, press "Start" on the treatment screen, and press "Start" once again in the profile screen. The illumination period of 10 minutes begins (see chapter 7.5.3).<br/>Remind the patient to remain still throughout the illumination period.<br/>If sound tone during treatment is activated, explain the beep sequence to the patient.<br/>If the patient needs a break, press "Break" on the profile standard screen. To resume treatment, press "Start" on the profile standard screen (see chapter 7.5.3).<br/>To abort the illumination, press "Stop" on the profile standard screen.<br/>Adjust fan speed as needed by patient by pressing plus or minus 1% or 10% on the profile standard screen.<br/>Stay with the patient at all times during the illumination period.</td> </tr> <tr class="Last"> <td valign="top">STEP 9)</td><td valign="top">At the end of the illumination period, remove patient's protective eyewear and follow further instructions in the Ameluz<span class="Sup">®</span> USPI.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1 px\" cellpadding=\"10\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td valign=\"top\">STEP 1)</td><td valign=\"top\">Plug in lamp.</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 2)</td><td valign=\"top\">Turn on the lamp and wait for home screen to appear (see chapter 7.3)</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 3)</td><td valign=\"top\">Check the proper functioning of the BF-RhodoLED<span class=\"Sup\">®</span>.</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 4)</td><td valign=\"top\">Treat the affected skin area: Application, incubation and removal of the topical medication following the USPI of Ameluz<span class=\"Sup\">®</span>.</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 5)</td><td valign=\"top\">Position patient comfortably and place protective eyewear on patient (see chapter 5).</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 6)</td><td valign=\"top\">Position the lamp and adjust the lamp head over the skin area to be treated (distance 5-8 cm) (see chapter 7.5.1).</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 7)</td><td valign=\"top\">Put on protective eyewear and make sure anyone remaining in the treatment room also wears protective eyewear (see chapter 5).</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 8)</td><td valign=\"top\">Start treatment by pressing \"Treatment\" on the home screen, press \"Start\" on the treatment screen, and press \"Start\" once again in the profile screen. The illumination period of 10 minutes begins (see chapter 7.5.3).<br/>Remind the patient to remain still throughout the illumination period.<br/>If sound tone during treatment is activated, explain the beep sequence to the patient.<br/>If the patient needs a break, press \"Break\" on the profile standard screen. To resume treatment, press \"Start\" on the profile standard screen (see chapter 7.5.3).<br/>To abort the illumination, press \"Stop\" on the profile standard screen.<br/>Adjust fan speed as needed by patient by pressing plus or minus 1% or 10% on the profile standard screen.<br/>Stay with the patient at all times during the illumination period.</td>\n</tr>\n<tr class=\"Last\">\n<td valign=\"top\">STEP 9)</td><td valign=\"top\">At the end of the illumination period, remove patient's protective eyewear and follow further instructions in the Ameluz<span class=\"Sup\">®</span> USPI.</td>\n</tr>\n</tbody>\n</table></div>" }

7 Detailed Operating Instructions

{ "type": "p", "children": [], "text": "\n\n7 Detailed Operating Instructions\n" }

Note: Every user of the BF-RhodoLED® has to be trained in operating the device. The initial training is provided by Biofrontera during set-up of the BF-RhodoLED®. Recurrent training is not mandatory but can be provided by Biofrontera employees. The device must be protected against unauthorized use.

{ "type": "p", "children": [], "text": "\nNote: Every user of the BF-RhodoLED® has to be trained in operating the device. The initial training is provided by Biofrontera during set-up of the BF-RhodoLED®. Recurrent training is not mandatory but can be provided by Biofrontera employees. The device must be protected against unauthorized use." }

<div class="scrollingtable"><table border="1" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td><img alt="Symbol 03" src="/dailymed/image.cfm?name=um-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>In order to avoid eye irritation, glare or injury, protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td><img alt=\"Symbol 03\" src=\"/dailymed/image.cfm?name=um-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>In order to avoid eye irritation, glare or injury, protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period.</td>\n</tr>\n</tbody>\n</table></div>" }

7.1 Transport of the lamp

{ "type": "p", "children": [], "text": "\n\n7.1 Transport of the lamp\n" }

The transportation of the lamp shall be done when the scissor arm is completely folded. During transportation one hand shall hold on to the support rail or storage shelf while the other hand holds the scissor arm (Figure 4).

{ "type": "p", "children": [], "text": "The transportation of the lamp shall be done when the scissor arm is completely folded. During transportation one hand shall hold on to the support rail or storage shelf while the other hand holds the scissor arm (Figure 4)." }

Figure 4: Transport of the lamp. (The appearance of devices from batches 001 to 003 slightly differs.)

{ "type": "p", "children": [], "text": "\nFigure 4: Transport of the lamp. (The appearance of devices from batches 001 to 003 slightly differs.)\n" }

7.2 Movement area of the scissor arm and the lamp head

{ "type": "p", "children": [], "text": "\n7.2 Movement area of the scissor arm and the lamp head\n" }

The scissor arm has a swivel range of +/- 24 degrees to the left and right. The swivel range is limited by a pin at the connection between scissor arm/ support rail and scissor arm/ lamp head (Figure 5).The lamp head can be adjusted horizontally and vertically and tilted sideways, as it has a swivel range of +/- 90 degrees in all three dimensions.

{ "type": "p", "children": [], "text": "The scissor arm has a swivel range of +/- 24 degrees to the left and right. The swivel range is limited by a pin at the connection between scissor arm/ support rail and scissor arm/ lamp head (Figure 5).The lamp head can be adjusted horizontally and vertically and tilted sideways, as it has a swivel range of +/- 90 degrees in all three dimensions." }

Figure 5: Limiting pins of the scissor arm and the lamp head. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)

{ "type": "p", "children": [], "text": "\nFigure 5: Limiting pins of the scissor arm and the lamp head. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)\n" }

7.3 Turning the Lamp On or Off

{ "type": "p", "children": [], "text": "\n7.3 Turning the Lamp On or Off \n" }

Note: Before turning on the lamp, the power cord must be plugged in. After connecting, the lamp can be turned on and used following the instructions below.

{ "type": "p", "children": [], "text": "\nNote: Before turning on the lamp, the power cord must be plugged in. After connecting, the lamp can be turned on and used following the instructions below." }

The on-off switch is located on the left side of the touchscreen monitor, close to its spiral cord. With the lamp plugged in, press the button to start the device.

{ "type": "p", "children": [], "text": "The on-off switch is located on the left side of the touchscreen monitor, close to its spiral cord. With the lamp plugged in, press the button to start the device." }

Important: This push button can also be used to turn the lamp off. Switching off the lamp can also be done by pressing the switch off button on the touchscreen (see chapter 7.4.2 "Home Screen").

{ "type": "p", "children": [], "text": "\n\nImportant: This push button can also be used to turn the lamp off. Switching off the lamp can also be done by pressing the switch off button on the touchscreen (see chapter 7.4.2 \"Home Screen\")." }

Figure 6: Touchscreen monitor

{ "type": "p", "children": [], "text": "\nFigure 6: Touchscreen monitor" }

Note: The blue LED of the push button indicates that the device is in stand-by mode.

{ "type": "p", "children": [], "text": "\nNote: The blue LED of the push button indicates that the device is in stand-by mode." }

7.4 Touchscreen Monitor and Menu

{ "type": "p", "children": [], "text": "\n\n7.4 Touchscreen Monitor and Menu\n" }

When using the touchscreen, please firmly press the center of the buttons shown on the screen to ensure it is read correctly by the software. Do not press too quickly, the input may not be read by the software. The touchscreen can be used while wearing commercially available examination gloves.

{ "type": "p", "children": [], "text": "When using the touchscreen, please firmly press the center of the buttons shown on the screen to ensure it is read correctly by the software. Do not press too quickly, the input may not be read by the software. The touchscreen can be used while wearing commercially available examination gloves." }

7.4.1 Start Screen

{ "type": "p", "children": [], "text": "\n\n7.4.1 Start Screen\n" }

The Biofrontera corporate logo and software version are displayed during the LED lamp operating system start-up (Figure 7). The operating system takes approximately 30 seconds to load.

{ "type": "p", "children": [], "text": "The Biofrontera corporate logo and software version are displayed during the LED lamp operating system start-up (Figure 7). The operating system takes approximately 30 seconds to load." }

Figure 7: Start screen

{ "type": "p", "children": [], "text": "\nFigure 7: Start screen" }

7.4.2 Home Screen

{ "type": "p", "children": [], "text": "\n\n7.4.2 Home Screen\n" }

The home screen appears after the operating system has loaded. From the home screen you can select "Treatment", "Settings" or "Service" (Figure 8). In the "Treatment" menu only one treatment profile "profile standard" is available. The illumination time and light intensity of this program are fixed (see 7.5.3 for further information). The "Settings" menu allows adjustment of language, time, date, audio signals and power saving settings (see 7.6 for further information). The "Service" menu may only be accessed by authorized personnel. You can turn the LED lamp off by pressing the button.

{ "type": "p", "children": [], "text": "The home screen appears after the operating system has loaded. From the home screen you can select \"Treatment\", \"Settings\" or \"Service\" (Figure 8). In the \"Treatment\" menu only one treatment profile \"profile standard\" is available. The illumination time and light intensity of this program are fixed (see 7.5.3 for further information). The \"Settings\" menu allows adjustment of language, time, date, audio signals and power saving settings (see 7.6 for further information). The \"Service\" menu may only be accessed by authorized personnel. You can turn the LED lamp off by pressing the button." }

Figure 8: Home screen

{ "type": "p", "children": [], "text": "\nFigure 8: Home screen" }

7.5 Conducting a Treatment

{ "type": "p", "children": [], "text": "\n\n7.5 Conducting a Treatment\n" }

Prior to treating a patient with Ameluz please ensure that BF-RhodoLED® is in good working order. Before starting a treatment, make sure the lamp is set-up in accordance with the operating instructions described in the following sections.

{ "type": "p", "children": [], "text": "Prior to treating a patient with Ameluz please ensure that BF-RhodoLED® is in good working order. Before starting a treatment, make sure the lamp is set-up in accordance with the operating instructions described in the following sections." }

7.5.1 Distance Indicator

{ "type": "p", "children": [], "text": "\n\n7.5.1 Distance Indicator\n" }

Position the lamp head over the skin area to be treated at a distance of 5-8 cm. Use the adjustable distance indicator and graduated scale bar to help measure and aid in achieving the correct distance (Figure 9).

{ "type": "p", "children": [], "text": "Position the lamp head over the skin area to be treated at a distance of 5-8 cm. Use the adjustable distance indicator and graduated scale bar to help measure and aid in achieving the correct distance (Figure 9)." }

Figure 9: Positioning of the lamp head to the treated skin area

{ "type": "p", "children": [], "text": "\nFigure 9: Positioning of the lamp head to the treated skin area" }

7.5.2 Adjustment Light

{ "type": "p", "children": [], "text": "\n7.5.2 Adjustment Light\n" }

To further aid positioning, use the adjustment light. On the touchscreen, press the following buttons in sequence (starting in the home screen): "Treatment" (Figure 8), "Adjust" (Figure 10) and "Start Adjustment" (Figure 11). The adjustment light shows what the field of illumination will be during treatment but at a lower intensity (6x16 cm, approx. 2.4 x 6.3 inches). When finished, press "Stop adjustment" and then "Back" (Figure 11) to return to the treatment menu (Figure 10).

{ "type": "p", "children": [], "text": "To further aid positioning, use the adjustment light. On the touchscreen, press the following buttons in sequence (starting in the home screen): \"Treatment\" (Figure 8), \"Adjust\" (Figure 10) and \"Start Adjustment\" (Figure 11). The adjustment light shows what the field of illumination will be during treatment but at a lower intensity (6x16 cm, approx. 2.4 x 6.3 inches). When finished, press \"Stop adjustment\" and then \"Back\" (Figure 11) to return to the treatment menu (Figure 10)." }

Figure 10: Treatment menu

{ "type": "p", "children": [], "text": "\nFigure 10: Treatment menu" }

Figure 11: Start and Stop adjustment

{ "type": "p", "children": [], "text": "\nFigure 11: Start and Stop adjustment" }

7.5.3 Treatment Menu

{ "type": "p", "children": [], "text": "\n\n7.5.3 Treatment Menu\n" }

Press treatment to enter the treatment menu (Figure 8). The standard illumination profile is depicted in a graph in the treatment menu. The x- and y-axis specify the treatment duration and light intensity respectively (Figure 12).

{ "type": "p", "children": [], "text": "Press treatment to enter the treatment menu (Figure 8). The standard illumination profile is depicted in a graph in the treatment menu. The x- and y-axis specify the treatment duration and light intensity respectively (Figure 12)." }

Figure 12: Treatment menu

{ "type": "p", "children": [], "text": "\nFigure 12: Treatment menu" }

In the treatment menu (Figure 12), press the "Start" button to access the profile standard screen.

{ "type": "p", "children": [], "text": "In the treatment menu (Figure 12), press the \"Start\" button to access the profile standard screen." }

7.5.4 Profile Standard Menu

{ "type": "p", "children": [], "text": "\n\n7.5.4 Profile Standard Menu\n" }

In the profile screen menu, press "Start" to begin treatment (Figure 13). You can interrupt the treatment at any time by pressing the "Break" button. Press the "Start" button to resume the treatment. Abort the current treatment by pressing the "Stop" button. If you press "Stop" prior to the end of the total treatment time, 10 minutes, the clock will reset and any interim treatment time will be not be saved.

{ "type": "p", "children": [], "text": "In the profile screen menu, press \"Start\" to begin treatment (Figure 13). You can interrupt the treatment at any time by pressing the \"Break\" button. Press the \"Start\" button to resume the treatment. Abort the current treatment by pressing the \"Stop\" button.\nIf you press \"Stop\" prior to the end of the total treatment time, 10 minutes, the clock will reset and any interim treatment time will be not be saved.\n" }

After pressing "Stop" or upon completion of the full 10 minute treatment the software will automatically return you to the treatment menu.

{ "type": "p", "children": [], "text": "After pressing \"Stop\" or upon completion of the full 10 minute treatment the software will automatically return you to the treatment menu." }

The remaining treatment time is displayed to the right of the graph and the red vertical line within the graph indicates the time that has elapsed.

{ "type": "p", "children": [], "text": "The remaining treatment time is displayed to the right of the graph and the red vertical line within the graph indicates the time that has elapsed." }

Figure 13: Profile standard

{ "type": "p", "children": [], "text": "\nFigure 13: Profile standard" }

7.5.5 Audio Signals during Treatment

{ "type": "p", "children": [], "text": "\n7.5.5 Audio Signals during Treatment\n" }

During treatment the patient will hear audio signals, 1 beep indicating 25 %, 2 beeps indicating 50 % and 3 beeps indicating 75 % of the PDT is completed, and upon treatment completion the lamp will stop the illumination and 4 beeps will be heard (see also chapter 7.6.2).

{ "type": "p", "children": [], "text": "During treatment the patient will hear audio signals, 1 beep indicating 25 %, 2 beeps indicating 50 % and 3 beeps indicating 75 % of the PDT is completed, and upon treatment completion the lamp will stop the illumination and 4 beeps will be heard (see also chapter 7.6.2)." }

7.5.6 Patient fan

{ "type": "p", "children": [], "text": "\n7.5.6 Patient fan\n" }

You can control the speed of the patient fan both before and during treatment with the plus and minus buttons, in increments of 1 % or 10 %. The patient fan continues to run when the treatment is paused ("Break"). The fan can be stopped by pressing "Stop" but be aware the treatment will also be aborted and any elapsed treatment time will not be saved. 7.6 Settings Menu

{ "type": "p", "children": [], "text": "You can control the speed of the patient fan both before and during treatment with the plus and minus buttons, in increments of 1 % or 10 %. The patient fan continues to run when the treatment is paused (\"Break\"). The fan can be stopped by pressing \"Stop\" but be aware the treatment will also be aborted and any elapsed treatment time will not be saved.\n\n7.6 Settings Menu\n" }

The settings menu is invoked (Figure 14) by pressing the "Settings" button in the home screen view (see Figure 12).

{ "type": "p", "children": [], "text": "The settings menu is invoked (Figure 14) by pressing the \"Settings\" button in the home screen view (see Figure 12)." }

Figure 14: Settings menu

{ "type": "p", "children": [], "text": "\nFigure 14: Settings menu" }

You can configure the following parameters in this menu:

{ "type": "p", "children": [], "text": "You can configure the following parameters in this menu:" }

{ "type": "ul", "children": [ "Language", "Signals", "Energy service (Power management)" ], "text": "" }

Switch back to the home screen menu via the "Back" button.

{ "type": "p", "children": [], "text": "Switch back to the home screen menu via the \"Back\" button." }

7.6.1 Language Settings

{ "type": "p", "children": [], "text": "\n\n7.6.1 Language Settings\n" }

Select a language by tapping on the desired language. Use the arrow keys to scroll through the list. Confirm the selected language with the "OK" button (Figure 15). Switch back to the settings menu without saving changes by pressing the "Back" button instead of "OK".

{ "type": "p", "children": [], "text": "Select a language by tapping on the desired language. Use the arrow keys to scroll through the list. Confirm the selected language with the \"OK\" button (Figure 15). Switch back to the settings menu without saving changes by pressing the \"Back\" button instead of \"OK\"." }

Figure 15: Language setting 7.6.2 Sound Settings

{ "type": "p", "children": [], "text": "\nFigure 15: Language setting\n\n7.6.2 Sound Settings\n" }

Activate and deactivate the audio signals for typing, warnings and sounds during the treatment. To do this, select the desired fields. A check mark means the sound is on.Confirm with the "OK" button (Figure 16) to save your settings or close the menu via the "Back" button to discard the setting.If "Turn off sound" is activated, all signal tones are switched off.

{ "type": "p", "children": [], "text": "Activate and deactivate the audio signals for typing, warnings and sounds during the treatment. To do this, select the desired fields. A check mark means the sound is on.Confirm with the \"OK\" button (Figure 16) to save your settings or close the menu via the \"Back\" button to discard the setting.If \"Turn off sound\" is activated, all signal tones are switched off." }

Important Note: Warning sounds will be emitted if an error occurs during operation of the lamp.

{ "type": "p", "children": [], "text": "\n\nImportant Note: Warning sounds will be emitted if an error occurs during operation of the lamp.\n" }

Figure 16: Sound setting

{ "type": "p", "children": [], "text": "\nFigure 16: Sound setting" }

7.6.3 Energy Service (Power Management)

{ "type": "p", "children": [], "text": "\n7.6.3 Energy Service (Power Management)\n" }

Providing the standby function is not manually deactivated via the check box "Never turn off lamp automatically" located near the bottom of the screen, the lamp will turn off after 10 minutes of non-use (Figure 17). You can change this time span in the menu "Energy service" via the plus and minus buttons. The settings are confirmed with the "OK" button and rejected with the "Back" button. In both cases you will return to the settings menu.

{ "type": "p", "children": [], "text": "Providing the standby function is not manually deactivated via the check box \"Never turn off lamp automatically\" located near the bottom of the screen, the lamp will turn off after 10 minutes of non-use (Figure 17). You can change this time span in the menu \"Energy service\" via the plus and minus buttons. The settings are confirmed with the \"OK\" button and rejected with the \"Back\" button. In both cases you will return to the settings menu." }

Figure 17: Energy management

{ "type": "p", "children": [], "text": "\nFigure 17: Energy management" }

If the configured time expires, a request appears for 10 seconds asking if you wish to prevent shut down. The LED lamp turns off automatically afterwards.

{ "type": "p", "children": [], "text": "\nIf the configured time expires, a request appears for 10 seconds asking if you wish to prevent shut down. The LED lamp turns off automatically afterwards." }

7.7 Service Menu

{ "type": "p", "children": [], "text": "\n\n7.7 Service Menu\n" }

Authorization is required to access the service menu. Only authorized personnel can access the service menu. 8 Error Messages

{ "type": "p", "children": [], "text": "Authorization is required to access the service menu. Only authorized personnel can access the service menu.\n\n8 Error Messages\n" }

The BF-RhodoLED® has an integrated monitoring function. In the event of a malfunction, an error message will appear in the message display. Possible error messages are set out in the table below.

{ "type": "p", "children": [], "text": "The BF-RhodoLED® has an integrated monitoring function. In the event of a malfunction, an error message will appear in the message display. Possible error messages are set out in the table below." }

<div class="scrollingtable"><table border="1" cellpadding="2" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Error message</span></td><td class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Possible causes</span></td><td class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Measures</span></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">Lamp overheated!</td><td class="Botrule Lrule Rrule Toprule" valign="top"> <ul> <li>The temperature of the surrounding environment is too high.</li> <li>The ventilators or ventilator slots are blocked.</li> <li>The air inlets or outlets are adversely affected.</li> </ul> </td><td class="Botrule Lrule Rrule Toprule" valign="top">Wait until the standard temperature has been reached.<br/>Check the ventilator and test the air inlets and outlets. Remove any visible foreign objects which may be present.<br/>In case of continuing impairment of cooling please contact your local sales representative or Biofrontera.</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">Lamp error!<br/>Please inform your supplier.</td><td class="Botrule Lrule Rrule Toprule" valign="top"> <ul> <li>Some of the LEDs have failed.</li> </ul> </td><td class="Botrule Lrule Rrule Toprule" valign="top">Further treatments may be carried out. However, please contact your local sales representative or Biofrontera immediately.</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">Communication error!</td><td class="Botrule Lrule Rrule Toprule" valign="top"> <ul> <li>Cable break in the touchscreen monitor spiral cord.</li> <li>Poor contact between the touchscreen monitor connection plug and the conduit box.</li> </ul> </td><td class="Botrule Lrule Rrule Toprule" valign="top">Confirm the communication error. Treatments can be continued in the treatment menu by pressing the "Start" button.<br/>Please contact your local sales representative or Biofrontera.</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">Lamp not calibrated!</td><td class="Botrule Lrule Rrule Toprule" valign="top"> <ul> <li>The lamp is not calibrated.</li> <li>Improper calibration.</li> </ul> </td><td class="Botrule Lrule Rrule Toprule" valign="top">The lamp has to be calibrated. Please contact your local sales representative or Biofrontera immediately.</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">Fehler-Nr.: 0084 Please inform your supplier.</td><td class="Botrule Lrule Rrule Toprule" valign="top"> <ul> <li>A temperature sensor has failed.</li> </ul> </td><td class="Botrule Lrule Rrule Toprule" valign="top">The lamp head has to be repaired. Please contact your local sales representative or Biofrontera.</td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top">Firmware of light head is faulty or missing!<br/>Please inform your supplier.</td><td class="Botrule Lrule Rrule Toprule" valign="top"> <ul> <li>An Update of the firmware has to be performed.</li> </ul> </td><td class="Botrule Lrule Rrule Toprule" valign="top">An update of the firmware has to be performed. Please contact your local sales representative or Biofrontera.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"2\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Error message</span></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Possible causes</span></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Measures</span></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Lamp overheated!</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<ul>\n<li>The temperature of the surrounding environment is too high.</li>\n<li>The ventilators or ventilator slots are blocked.</li>\n<li>The air inlets or outlets are adversely affected.</li>\n</ul>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Wait until the standard temperature has been reached.<br/>Check the ventilator and test the air inlets and outlets. Remove any visible foreign objects which may be present.<br/>In case of continuing impairment of cooling please contact your local sales representative or Biofrontera.</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Lamp error!<br/>Please inform your supplier.</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<ul>\n<li>Some of the LEDs have failed.</li>\n</ul>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Further treatments may be carried out. However, please contact your local sales representative or Biofrontera immediately.</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Communication error!</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<ul>\n<li>Cable break in the touchscreen monitor spiral cord.</li>\n<li>Poor contact between the touchscreen monitor connection plug and the conduit box.</li>\n</ul>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Confirm the communication error. Treatments can be continued in the treatment menu by pressing the \"Start\" button.<br/>Please contact your local sales representative or Biofrontera.</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Lamp not calibrated!</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<ul>\n<li>The lamp is not calibrated.</li>\n<li>Improper calibration.</li>\n</ul>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">The lamp has to be calibrated. Please contact your local sales representative or Biofrontera immediately.</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Fehler-Nr.: 0084 Please inform your supplier.</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<ul>\n<li>A temperature sensor has failed.</li>\n</ul>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">The lamp head has to be repaired. Please contact your local sales representative or Biofrontera.</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Firmware of light head is faulty or missing!<br/>Please inform your supplier.</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<ul>\n<li>An Update of the firmware has to be performed.</li>\n</ul>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">An update of the firmware has to be performed. Please contact your local sales representative or Biofrontera.</td>\n</tr>\n</tbody>\n</table></div>" }

If your LED lamp no longer functions properly for some unknown reason, proceed as follows:

{ "type": "p", "children": [], "text": "If your LED lamp no longer functions properly for some unknown reason, proceed as follows:" }

{ "type": "ul", "children": [ "Unplug the power supply for half a minute and then plug back into the outlet (This action prompts a software reboot).", "Turn the lamp back on using the touchscreen monitor and verify functionality." ], "text": "" }

Should the problem persist, please contact your sales representative or Biofrontera. The lamp may not be used until the problem has been rectified.

{ "type": "p", "children": [], "text": "Should the problem persist, please contact your sales representative or Biofrontera. The lamp may not be used until the problem has been rectified." }

For all other malfunctions and difficulties with operation please contact your sales representative or Biofrontera. You will find the contact details on page 2.

{ "type": "p", "children": [], "text": "For all other malfunctions and difficulties with operation please contact your sales representative or Biofrontera. You will find the contact details on page 2." }

9 Servicing

{ "type": "p", "children": [], "text": "\n\n9 Servicing\n" }

Servicing may only be performed by Biofrontera-authorized personnel. If servicing is done by third parties, BF-RhodoLED® warranty is void and Biofrontera cannot be held responsible for potential malfunctions or damages of the device. It is recommended to have the lamp serviced after two years.

{ "type": "p", "children": [], "text": "\nServicing may only be performed by Biofrontera-authorized personnel. If servicing is done by third parties, BF-RhodoLED® warranty is void and Biofrontera cannot be held responsible for potential malfunctions or damages of the device. It is recommended to have the lamp serviced after two years.\n" }

During service, the gas springs (gas pressure springs and gas traction springs) in the scissor arm as well as the general safety condition of the BF-RhodoLED® are checked.

{ "type": "p", "children": [], "text": "\nDuring service, the gas springs (gas pressure springs and gas traction springs) in the scissor arm as well as the general safety condition of the BF-RhodoLED® are checked." }

Contact your sales representative or Biofrontera to schedule all service appointments.

{ "type": "p", "children": [], "text": "\nContact your sales representative or Biofrontera to schedule all service appointments." }

10 Maintenance and Cleaning

{ "type": "p", "children": [], "text": "\n\n10 Maintenance and Cleaning\n" }

The device may under no circumstances be cleaned with aggressive cleaning agents or solvents (e.g. acetone or highly concentrated ethanol), as these promote wear and tear of the surface (paint coating), safety signs and graduated scale bar as well as the logo. Please avoid allowing any penetration of liquids into the lamp, BF-RhodoLED® is not waterproof and the electronics inside may be damaged.

{ "type": "p", "children": [], "text": "The device may under no circumstances be cleaned with aggressive cleaning agents or solvents (e.g. acetone or highly concentrated ethanol), as these promote wear and tear of the surface (paint coating), safety signs and graduated scale bar as well as the logo. Please avoid allowing any penetration of liquids into the lamp, BF-RhodoLED® is not waterproof and the electronics inside may be damaged." }

Always unplug the lamp prior to cleaning and please observe the following cleaning practices:

{ "type": "p", "children": [], "text": "Always unplug the lamp prior to cleaning and please observe the following cleaning practices:" }

<div class="scrollingtable"><table border="1" cellpadding="5" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td valign="top"><span class="Underline">Daily:</span></td><td valign="top">Wipe the plexiglass screen located on the bottom of the lamp head with a damp soft cloth (e. g. a microfiber cloth).</td> </tr> <tr> <td valign="top"><span class="Underline">Weekly:</span></td><td valign="top"> <p class="First">Wipe the entire lamp. Do not use a very wet or dripping cleaning cloth. The unit is not waterproof, and damage could occur. Weekly cleaning can be carried out using a damp cloth. If a disinfection of the device is desired, a mild disinfecting agent can be used. Most commercially available products, which are suitable for plastics, should be compatible with BF-RhodoLED<span class="Sup">®</span>. A know exception is the agent "Incidin Plus<span class="Sup">TM</span>" (active ingredient: Glucoprotamine) which can cause corrosion of the lamp head surfaces.</p> <p> <br/>Before using a disinfection agent, always refer to its manual to check for compatibility with plastic surfaces, especially with Plexiglas.</p> <p> <br/>Note: If you notice any deterioration of a surface of BF-RhodoLED after using a disinfectant, please stop further use and contact Biofrontera.</p> </td> </tr> <tr> <td colspan="2" valign="top"><span class="Underline">Please observe the following checks:</span></td> </tr> <tr class="Last"> <td valign="top"><span class="Underline">Monthly:</span></td><td>Check lamp for obvious visible damage such as damaged cables, worn off labeling, cracks on the lamp housing, etc. Do not use a damaged device for treatment and please inform your supplier.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"5\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td valign=\"top\"><span class=\"Underline\">Daily:</span></td><td valign=\"top\">Wipe the plexiglass screen located on the bottom of the lamp head with a damp soft cloth (e. g. a microfiber cloth).</td>\n</tr>\n<tr>\n<td valign=\"top\"><span class=\"Underline\">Weekly:</span></td><td valign=\"top\">\n<p class=\"First\">Wipe the entire lamp. Do not use a very wet or dripping cleaning cloth. The unit is not waterproof, and damage could occur. Weekly cleaning can be carried out using a damp cloth. If a disinfection of the device is desired, a mild disinfecting agent can be used. Most commercially available products, which are suitable for plastics, should be compatible with BF-RhodoLED<span class=\"Sup\">®</span>. A know exception is the agent \"Incidin Plus<span class=\"Sup\">TM</span>\" (active ingredient: Glucoprotamine) which can cause corrosion of the lamp head surfaces.</p>\n<p>\n<br/>Before using a disinfection agent, always refer to its manual to check for compatibility with plastic surfaces, especially with Plexiglas.</p>\n<p>\n<br/>Note: If you notice any deterioration of a surface of BF-RhodoLED after using a disinfectant, please stop further use and contact Biofrontera.</p>\n</td>\n</tr>\n<tr>\n<td colspan=\"2\" valign=\"top\"><span class=\"Underline\">Please observe the following checks:</span></td>\n</tr>\n<tr class=\"Last\">\n<td valign=\"top\"><span class=\"Underline\">Monthly:</span></td><td>Check lamp for obvious visible damage such as damaged cables, worn off labeling, cracks on the lamp housing, etc. Do not use a damaged device for treatment and please inform your supplier.</td>\n</tr>\n</tbody>\n</table></div>" }

11 Disposal Instructions

{ "type": "p", "children": [], "text": "\n11 Disposal Instructions\n" }

Follow all local and governmental disposal laws and regulations when disposing of the BF-RhodoLED®.

{ "type": "p", "children": [], "text": "Follow all local and governmental disposal laws and regulations when disposing of the BF-RhodoLED®." }

12 Technical Data

{ "type": "p", "children": [], "text": "\n\n12 Technical Data\n" }

12.1 Electrical connectors

{ "type": "p", "children": [], "text": "\n12.1 Electrical connectors\n" }

Power supply unit:

{ "type": "p", "children": [], "text": "\nPower supply unit:\n" }

{ "type": "ul", "children": [ "Primary wide-range input 100-240 VAC", "Secondary safety extra-low voltage output 48 VDC", "Secondary standby voltage output 5 VDC" ], "text": "" }

Mother board for voltage management and control:

{ "type": "p", "children": [], "text": "\nMother board for voltage management and control:\n" }

{ "type": "ul", "children": [ "Supply voltage input 48 VDC", "Standby voltage input 5 VDC plus Standby contact", "RS485 interface", "Output supply voltage HMI board 24 VDC", "4 x ports LED board 8-pin (2 x LED circuits, temperature (3-pin))", "4 x connector ventilator (2-pin)" ], "text": "" }

LED board:

{ "type": "p", "children": [], "text": "\nLED board:\n" }

{ "type": "ul", "children": [ "2 x ports mother board 8-pin (2 x LED circuits, temperature (3-pin))" ], "text": "" }

Human Machine Interface (HMI) for operation:

{ "type": "p", "children": [], "text": "\nHuman Machine Interface (HMI) for operation:\n" }

{ "type": "ul", "children": [ "Supply voltage input 24 VDC", "RS485 interface" ], "text": "" }

12.2 Specification

{ "type": "p", "children": [], "text": "\n12.2 Specification\n" }

<div class="scrollingtable"><table border="1" cellpadding="5" width="884px"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Type</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">BF-RhodoLED<span class="Sup">®</span> </p> <p>Medical device class III; Device of protection class 1</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Certification</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">UL certified</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Software Version No.</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">1.6_US_CAN</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Service life of the lamp</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Approx. 4 years</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Shelf life</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">1.5 years</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Number of LEDs</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">128</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Typical peak wavelength</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">635 nm ± 5 nm</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Light dose (6 cm distance, 10 min)</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Approx. 37 J/ cm<span class="Sup">2</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Typical irradiance</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">61 mW/cm<span class="Sup">2</span> +/- 15 %</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Max irradiance</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">77 mW/cm<span class="Sup">2</span> +/- 15 % (at 5 cm treatment distance)</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Illuminated area</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">An area of 8x18 (approx. 3.1 x 7.1 inches) cm is illuminated. The effective treatment area is 6x16 cm (approx. 2.4 x 6.3 inches).</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Max. deviation of the intensity over the treatment area</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Approx. 15 %</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Transport and storage conditions</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Temperature: -30°C to +60°C (-22°F to +140°F)</p> <p>Atmospheric pressure: 500 hPa - 1060 hPa<br/>Relative humidity: 10% - 90%, non-condensing</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Operating conditions</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Temperature: 0°C to +40°C (32°F to +104°F)</p> <p>Atmospheric pressure: 700 hPa - 1060 hPa<br/>Operational altitude: ≤ 2000 m above NN<br/>Relative humidity: 10% - 90%, non-condensing<br/>This PDT lamp is suitable for continuous operation.</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Operating voltage</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">120-240 VAC, 50/60 Hz</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Output voltage</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">48 VDC</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Power consumption</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">In calibrated normal operation: approx. 140 VA</p> <p>In standby mode: approx. 85 VA</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Over-voltage category</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">II</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Degree of contamination</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">2</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Material group (CTI)</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">IIIb</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Protection class</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">IP20</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Size of the lamp</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">95 x 62 x 168 cm (37 x 24 x 66 inches)<br/>Devices of batch 001 to 003: 127 x 56 x 168 cm (50 x 22 x 66 inches)</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Total lamp weight</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Approx. 52 kg (115 lbs)<br/>Devices of batch 001 to 003: approx. 48 kg (106 lbs)</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"5\" width=\"884px\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Type</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">BF-RhodoLED<span class=\"Sup\">®</span>\n</p>\n<p>Medical device class III; Device of protection class 1</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Certification</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">UL certified</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Software Version No.</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">1.6_US_CAN</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Service life of the lamp</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Approx. 4 years</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Shelf life</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">1.5 years</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Number of LEDs</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">128</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Typical peak wavelength</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">635 nm ± 5 nm</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Light dose (6 cm distance, 10 min)</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Approx. 37 J/ cm<span class=\"Sup\">2</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Typical irradiance</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">61 mW/cm<span class=\"Sup\">2</span> +/- 15 %</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Max irradiance</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">77 mW/cm<span class=\"Sup\">2</span> +/- 15 % (at 5 cm treatment distance)</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Illuminated area</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">An area of 8x18 (approx. 3.1 x 7.1 inches) cm is illuminated. The effective treatment area is 6x16 cm (approx. 2.4 x 6.3 inches).</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Max. deviation of the intensity over the treatment area</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Approx. 15 %</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Transport and storage conditions</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Temperature: -30°C to +60°C (-22°F to +140°F)</p>\n<p>Atmospheric pressure: 500 hPa - 1060 hPa<br/>Relative humidity: 10% - 90%, non-condensing</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Operating conditions</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Temperature: 0°C to +40°C (32°F to +104°F)</p>\n<p>Atmospheric pressure: 700 hPa - 1060 hPa<br/>Operational altitude: ≤ 2000 m above NN<br/>Relative humidity: 10% - 90%, non-condensing<br/>This PDT lamp is suitable for continuous operation.</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Operating voltage</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">120-240 VAC, 50/60 Hz</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Output voltage</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">48 VDC</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Power consumption</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">In calibrated normal operation: approx. 140 VA</p>\n<p>In standby mode: approx. 85 VA</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Over-voltage category</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">II</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Degree of contamination</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">2</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Material group (CTI)</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">IIIb</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Protection class</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">IP20</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Size of the lamp</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">95 x 62 x 168 cm (37 x 24 x 66 inches)<br/>Devices of batch 001 to 003: 127 x 56 x 168 cm (50 x 22 x 66 inches)</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Total lamp weight</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Approx. 52 kg (115 lbs)<br/>Devices of batch 001 to 003: approx. 48 kg (106 lbs)</td>\n</tr>\n</tbody>\n</table></div>" }

For further information please directly contact Biofrontera. 13 Labeling and Symbols

{ "type": "p", "children": [], "text": "For further information please directly contact Biofrontera.\n\n13 Labeling and Symbols\n" }

13.1 Labeling on the Lamp

{ "type": "p", "children": [], "text": "\n13.1 Labeling on the Lamp\n" }

The product sticker is located on the reverse side of the lamp base (see Figure 18). It contains manufacturer and product specifications (classification, serial and order number and the power supply used) as well as IP (Ingress) protection. In addition, a unique device identifier label is placed next to the product sticker.

{ "type": "p", "children": [], "text": "The product sticker is located on the reverse side of the lamp base (see Figure 18). It contains manufacturer and product specifications (classification, serial and order number and the power supply used) as well as IP (Ingress) protection. In addition, a unique device identifier label is placed next to the product sticker." }

Figure 18: Product and UDI label. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)

{ "type": "p", "children": [], "text": "\nFigure 18: Product and UDI label. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)\n" }

Labels with safety instructions, special disposal instructions and further instructions are represented in the following figures.

{ "type": "p", "children": [], "text": "Labels with safety instructions, special disposal instructions and further instructions are represented in the following figures." }

Figure 19: Instructions and notes on the lamp head

{ "type": "p", "children": [], "text": "\nFigure 19: Instructions and notes on the lamp head" }

Figure 20: Instructions on the storage shelf. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)

{ "type": "p", "children": [], "text": "\nFigure 20: Instructions on the storage shelf. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)\n" }

Figure 21: Instructions on the scissors arm. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)

{ "type": "p", "children": [], "text": "\nFigure 21: Instructions on the scissors arm. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)\n" }

Instructions for existing ground connector connections (see Figure 22) are located:

{ "type": "p", "children": [], "text": "Instructions for existing ground connector connections (see Figure 22) are located:" }

{ "type": "ul", "children": [ "Next to the grounding screws, which are located within and next to the power supply cover box beneath the mobile castor, respectively", "On the power supply cover box (see Figure 23)" ], "text": "" }

Figure 22: Instructions for ground connector connection

{ "type": "p", "children": [], "text": "\nFigure 22: Instructions for ground connector connection" }

Figure 23: BF-RhodoLED®. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)

{ "type": "p", "children": [], "text": "\nFigure 23: BF-RhodoLED®. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)\n" }

Instructions on the existing potential compensator conductor is located on the carrier bar beneath the potential compensator conductor (see Figure 24).

{ "type": "p", "children": [], "text": "Instructions on the existing potential compensator conductor is located on the carrier bar beneath the potential compensator conductor (see Figure 24)." }

Figure 24: Potential compensator conductor. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)

{ "type": "p", "children": [], "text": "\nFigure 24: Potential compensator conductor. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)\n" }

All depicted symbols are summarized in a table in section 13.2 "Explanation of symbols".

{ "type": "p", "children": [], "text": "All depicted symbols are summarized in a table in section 13.2 \"Explanation of symbols\"." }

13.2 Description of Symbols

{ "type": "p", "children": [], "text": "\n13.2 Description of Symbols\n" }

<div class="scrollingtable"><table border="1" cellpadding="5" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Symbol</span></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Description</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 03" src="/dailymed/image.cfm?name=um-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Eye protection is required.</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle">IP20</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">IP (Ingress Protection):<br/>Protection class of the housing against contact, foreign bodies and water<br/>2 = against ingress of solid foreign bodies ≥ 12,5 mm Ø and larger<br/>0 = <span class="Underline">Not</span> protected against water</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 06" src="/dailymed/image.cfm?name=um-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Technical and electric devices must not be disposed of with household waste. Please pay attention to the applicable disposal instructions found in the user manual.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 07" src="/dailymed/image.cfm?name=um-symbol-07.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Symbol for existing ground connector connections</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 02" src="/dailymed/image.cfm?name=um-symbol-02.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Follow the instructions for use!</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 01" src="/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Underline">General warning signs:</span> <br/> <ul> <li>Assembly and servicing may <span class="Underline">ONLY</span> be performed by Biofrontera!</li> <li>Only transport lamp in the park position!</li> <li>The mobility of the extension and scissors arm may be obstructed by objects!</li> <li>Caution: heavy, do NOT lift alone.</li> <li>NEVER place this unit on an unstable, uneven surface!</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 04" src="/dailymed/image.cfm?name=um-symbol-04.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Warning sign - risk of trapping fingers!</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 08" src="/dailymed/image.cfm?name=um-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Symbol for existing potential compensation conductor<br/> <span class="Italics"><span class="Underline">Function/Application:</span></span> <br/>The purpose of a potential compensation conductor is to connect all conducting, metallic parts of a system to each other by the protective earthing in order to achieve the same electrical potential for the connected parts. Protection against contact voltage is thus guaranteed. Releasing the potential compensation conductor is forbidden. It should be firmly fitted to the support splint.<br/>Please observe the requirements for ME-systems set out in EN 60601-1 when using the potential compensation cable (chapter 16).</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 09" src="/dailymed/image.cfm?name=um-symbol-09.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Please do not stand on or push. There is a risk that the device may fall over through of the force applied.</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 10" src="/dailymed/image.cfm?name=um-symbol-10.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Please do not sit on the equipment. There is a risk that the device may fall over through the force applied.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"5\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><span class=\"Bold\">Symbol</span></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><span class=\"Bold\">Description</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 03\" src=\"/dailymed/image.cfm?name=um-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Eye protection is required.</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">IP20</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">IP (Ingress Protection):<br/>Protection class of the housing against contact, foreign bodies and water<br/>2 = against ingress of solid foreign bodies ≥ 12,5 mm Ø and larger<br/>0 = <span class=\"Underline\">Not</span> protected against water</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 06\" src=\"/dailymed/image.cfm?name=um-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Technical and electric devices must not be disposed of with household waste. Please pay attention to the applicable disposal instructions found in the user manual.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 07\" src=\"/dailymed/image.cfm?name=um-symbol-07.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Symbol for existing ground connector connections</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 02\" src=\"/dailymed/image.cfm?name=um-symbol-02.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Follow the instructions for use!</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 01\" src=\"/dailymed/image.cfm?name=um-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><span class=\"Underline\">General warning signs:</span>\n<br/>\n<ul>\n<li>Assembly and servicing may <span class=\"Underline\">ONLY</span> be performed by Biofrontera!</li>\n<li>Only transport lamp in the park position!</li>\n<li>The mobility of the extension and scissors arm may be obstructed by objects!</li>\n<li>Caution: heavy, do NOT lift alone.</li>\n<li>NEVER place this unit on an unstable, uneven surface!</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 04\" src=\"/dailymed/image.cfm?name=um-symbol-04.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Warning sign - risk of trapping fingers!</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 08\" src=\"/dailymed/image.cfm?name=um-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Symbol for existing potential compensation conductor<br/>\n<span class=\"Italics\"><span class=\"Underline\">Function/Application:</span></span>\n<br/>The purpose of a potential compensation conductor is to connect all conducting, metallic parts of a system to each other by the protective earthing in order to achieve the same electrical potential for the connected parts. Protection against contact voltage is thus guaranteed. Releasing the potential compensation conductor is forbidden. It should be firmly fitted to the support splint.<br/>Please observe the requirements for ME-systems set out in EN 60601-1 when using the potential compensation cable (chapter 16).</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 09\" src=\"/dailymed/image.cfm?name=um-symbol-09.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Please do not stand on or push. There is a risk that the device may fall over through of the force applied.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 10\" src=\"/dailymed/image.cfm?name=um-symbol-10.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Please do not sit on the equipment. There is a risk that the device may fall over through the force applied.</td>\n</tr>\n</tbody>\n</table></div>" }

13.3 Labeling on the Packaging

{ "type": "p", "children": [], "text": "\n\n13.3 Labeling on the Packaging\n" }

{ "type": "ul", "children": [ "Attention: Protect from moisture and keep dry!", "Attention: Do not throw the package, damage possible!", "Attention: Please transport and store at -30°C/ -22°F to +60°C/ 140°F, a relative humidity of 10 % to 90 % and at an atmospheric pressure of 500 hPa (50 kPa) - 1060 hPa (106 kPa)." ], "text": "" }

{ "type": "ul", "children": [ "This side up!" ], "text": "" }

{ "type": "ul", "children": [ "Caution, one end of the package is heavy" ], "text": "" }

{ "type": "ul", "children": [ "Contains a lithium metal battery (optionally, not required starting from batch 007)" ], "text": "" }

14 Electromagnetic compatibility (EMC)

{ "type": "p", "children": [], "text": "\n14 Electromagnetic compatibility (EMC)\n" }

BF-RhodoLED® meets the EMC requirements of the international standard EN60601-1-2:2015 Chapter 7 and 8. Other electrical devices can have an impact on the device. Using accessories that have not been approved can have a negative impact on the device and change the electromagnetic compatibility.BF-RhodoLED® should not be used directly alongside or between other electrical devices.

{ "type": "p", "children": [], "text": "BF-RhodoLED® meets the EMC requirements of the international standard EN60601-1-2:2015 Chapter 7 and 8. Other electrical devices can have an impact on the device. Using accessories that have not been approved can have a negative impact on the device and change the electromagnetic compatibility.BF-RhodoLED® should not be used directly alongside or between other electrical devices." }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td>Guidelines and manufacturer's declaration - electromagnetic emissions</td> </tr> <tr class="Last"> <td> <p class="First">BF-RhodoLED<span class="Sup">®</span> is intended for operation in the electromagnetic environment detailed below.</p> <p>The customer or operator of the device should ensure that it is operated in this environment.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td>Guidelines and manufacturer's declaration - electromagnetic emissions</td>\n</tr>\n<tr class=\"Last\">\n<td>\n<p class=\"First\">BF-RhodoLED<span class=\"Sup\">®</span> is intended for operation in the electromagnetic environment detailed below.</p>\n<p>The customer or operator of the device should ensure that it is operated in this environment.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td><span class="Bold">Emission readings</span></td><td><span class="Bold"> Conformity</span></td><td><span class="Bold"> Electromagnetic environment - guidelines</span></td> </tr> <tr> <td>HF emissions CISPR   11</td><td>Group 1</td><td> <p class="First">BF-RhodoLED<span class="Sup">®</span> only uses HF energy for its internal functionality.</p> <p>For this reason, its HF emission is very low and it is not likely that neighbouring electronic  devices would   be   disturbed.</p> </td> </tr> <tr class="Last"> <td> <p class="First">HF emissions in accordance with  CISPR 11</p> <p></p> <p>Harmonics in accordance with IEC  61000-3-2</p> <p></p> <p>Voltage fluctuations/flickers in  accordance with IEC 61000 3-3</p> </td><td> <p class="First">Class B</p> <p></p> <p></p> <p>Class A</p> <p></p> <p></p> <p>In  compliance</p> </td><td>BF-RhodoLED<span class="Sup">®</span> is intended for operation in non-residential facilities and such like that are  connected directly to a public low-voltage supply network that also supplies residential  buildings.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><span class=\"Bold\">Emission readings</span></td><td><span class=\"Bold\"> Conformity</span></td><td><span class=\"Bold\"> Electromagnetic environment - guidelines</span></td>\n</tr>\n<tr>\n<td>HF emissions CISPR   11</td><td>Group 1</td><td>\n<p class=\"First\">BF-RhodoLED<span class=\"Sup\">®</span> only uses HF energy for its internal functionality.</p>\n<p>For this reason, its HF emission is very low and it is not likely that neighbouring electronic  devices would   be   disturbed.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td>\n<p class=\"First\">HF emissions in accordance with  CISPR 11</p>\n<p></p>\n<p>Harmonics in accordance with IEC  61000-3-2</p>\n<p></p>\n<p>Voltage fluctuations/flickers in  accordance with IEC 61000 3-3</p>\n</td><td>\n<p class=\"First\">Class B</p>\n<p></p>\n<p></p>\n<p>Class A</p>\n<p></p>\n<p></p>\n<p>In  compliance</p>\n</td><td>BF-RhodoLED<span class=\"Sup\">®</span> is intended for operation in non-residential facilities and such like that are  connected directly to a public low-voltage supply network that also supplies residential  buildings.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td>Guidelines and manufacturer's declaration - electromagnetic immunity</td> </tr> <tr class="Last"> <td> <p class="First">BF-RhodoLED<span class="Sup">®</span> is intended for operation in the electromagnetic environment detailed below.</p> <p>The customer or operator of the device should ensure that it is operated in this environment.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td>Guidelines and manufacturer's declaration - electromagnetic immunity</td>\n</tr>\n<tr class=\"Last\">\n<td>\n<p class=\"First\">BF-RhodoLED<span class=\"Sup\">®</span> is intended for operation in the electromagnetic environment detailed below.</p>\n<p>The customer or operator of the device should ensure that it is operated in this environment.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td><span class="Bold">Immunity tests</span></td><td><span class="Bold"> IEC 60601 test levels</span></td><td><span class="Bold"> Compliance level</span></td><td><span class="Bold">Electromagnetic environment - guidelines </span></td> </tr> <tr> <td>Static discharge in accordance  with IEC 61000-4-2</td><td>±8 kV contact discharge ±2 kV,  ±4 kV, ±8 kV and ±15 kV air  discharge</td><td>±8 kV contact discharge ±2 kV,  ±4 kV, ±8 kV and ±15 kV air  discharge</td><td>Floors should be made of wood or concrete or finished with ceramic tiles. If the floor is finished with synthetic material, the relative air humidity must be at least 30 %.</td> </tr> <tr> <td>Fast, transient electrical  disturbances/bursts in  accordance with IEC 61000-4-4</td><td>±2 kV for mains lines ±1 kV for input and output lines</td><td>±2 kV for mains lines</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.</td> </tr> <tr> <td>Surges in accordance with IEC  61000-4-5</td><td>±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth</td><td>±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.</td> </tr> <tr> <td>Voltage drops, brief  interruptions and fluctuations in  the supply voltage in accordance  with IEC 61000-4-11</td><td>0 % U<span class="Sub">T</span> for 0.5 cycles at phase angles of 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° (applicable only to me equipment connected to single-phase a.c. mains)<br/>0 % U<span class="Sub">T</span> for 1 cycle<br/>70 % U<span class="Sub">T</span> for 25/30 cycles<br/>0 % U<span class="Sub">T</span> for 250/300 cycles</td><td>0 % U<span class="Sub">T</span> for 0.5 cycles at phase angles of 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° (applicable only to me equipment connected to single-phase a.c. mains)<br/>0 % U<span class="Sub">T</span> for 1 cycle<br/>70 % U<span class="Sub">T</span> for 25/30 cycles<br/>0 % U<span class="Sub">T</span> for 250/300 cycles</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.<br/>If the operator of the device needs functionality to be maintained despite interruptions in the energy supply, it is advisable to run the device on an uninterruptable power supply or a battery.</td> </tr> <tr class="Last"> <td>Power frequency (50/60 Hz) magnetic field in accordance with IEC 61000-4-8</td><td>3 A/m</td><td>3 A/m</td><td> <p class="First">Mains frequency magnetic fields should correspond to the values typically found in the commercial and hospital</p> <p>environment.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><span class=\"Bold\">Immunity tests</span></td><td><span class=\"Bold\"> IEC 60601 test levels</span></td><td><span class=\"Bold\"> Compliance level</span></td><td><span class=\"Bold\">Electromagnetic environment - guidelines </span></td>\n</tr>\n<tr>\n<td>Static discharge in accordance  with IEC 61000-4-2</td><td>±8 kV contact discharge ±2 kV,  ±4 kV, ±8 kV and ±15 kV air  discharge</td><td>±8 kV contact discharge ±2 kV,  ±4 kV, ±8 kV and ±15 kV air  discharge</td><td>Floors should be made of wood or concrete or finished with ceramic tiles. If the floor is finished with synthetic material, the relative air humidity must be at least 30 %.</td>\n</tr>\n<tr>\n<td>Fast, transient electrical  disturbances/bursts in  accordance with IEC 61000-4-4</td><td>±2 kV for mains lines ±1 kV for input and output lines</td><td>±2 kV for mains lines</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.</td>\n</tr>\n<tr>\n<td>Surges in accordance with IEC  61000-4-5</td><td>±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth</td><td>±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.</td>\n</tr>\n<tr>\n<td>Voltage drops, brief  interruptions and fluctuations in  the supply voltage in accordance  with IEC 61000-4-11</td><td>0 % U<span class=\"Sub\">T</span> for 0.5 cycles at phase angles of 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° (applicable only to me equipment connected to single-phase a.c. mains)<br/>0 % U<span class=\"Sub\">T</span> for 1 cycle<br/>70 % U<span class=\"Sub\">T</span> for 25/30 cycles<br/>0 % U<span class=\"Sub\">T</span> for 250/300 cycles</td><td>0 % U<span class=\"Sub\">T</span> for 0.5 cycles at phase angles of 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° (applicable only to me equipment connected to single-phase a.c. mains)<br/>0 % U<span class=\"Sub\">T</span> for 1 cycle<br/>70 % U<span class=\"Sub\">T</span> for 25/30 cycles<br/>0 % U<span class=\"Sub\">T</span> for 250/300 cycles</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.<br/>If the operator of the device needs functionality to be maintained despite interruptions in the energy supply, it is advisable to run the device on an uninterruptable power supply or a battery.</td>\n</tr>\n<tr class=\"Last\">\n<td>Power frequency (50/60 Hz) magnetic field in accordance with IEC 61000-4-8</td><td>3 A/m</td><td>3 A/m</td><td>\n<p class=\"First\">Mains frequency magnetic fields should correspond to the values typically found in the commercial and hospital</p>\n<p>environment.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td> <p class="First">Comment: U<span class="Sub">T</span> is the mains AC voltage prior to application of the test level</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td>\n<p class=\"First\">Comment: U<span class=\"Sub\">T</span> is the mains AC voltage prior to application of the test level</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td>Guidelines and manufacturer's declaration - electromagnetic immunity</td> </tr> <tr class="Last"> <td>BF-RhodoLED<span class="Sup">®</span> is intended for operation in the electromagnetic environment detailed below. The customer or operator of the device should ensure that it is operated in this environment.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td>Guidelines and manufacturer's declaration - electromagnetic immunity</td>\n</tr>\n<tr class=\"Last\">\n<td>BF-RhodoLED<span class=\"Sup\">®</span> is intended for operation in the electromagnetic environment detailed below. The customer or operator of the device should ensure that it is operated in this environment.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First" valign="top"> <td><span class="Bold">Immunity tests</span></td><td><span class="Bold">IEC 60601 test levels</span></td><td><span class="Bold">Compliance level</span></td><td><span class="Bold">Electromagnetic environment - guidelines </span></td> </tr> <tr class="Last" valign="top"> <td> <p class="First">Conducted HF disturbances in accordance with IEC 61000-4-6</p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p>Radiated HF disturbances in accordance with IEC 61000-4-3</p> </td><td> <p class="First">3 V<br/>150 kHz to 80 MHz</p> <p></p> <p>6 V<br/>ISM bands 0.15 - 80 MHz<br/>80 % AM with 1 kHz</p> <p></p> <p>3 V/m 80 MHz to 2.7 GHz<br/>80 % AM with 1 kHz</p> </td><td> <p class="First">3 V</p> <p></p> <p></p> <p></p> <p>6 V</p> <p></p> <p></p> <p></p> <p></p> <p></p> <p>3 V/m</p> </td><td> <p class="First">Portable and mobile communication devices should not be used in closer proximity of the unit or its cables than the recommended safety distance of 300 mm.</p> <p></p> <p></p> <p></p> <p></p> <p></p> <p>Interference may occur in the vicinity of equipment marked with the following symbol.</p> <p> <img alt="Symbol 05" src="/dailymed/image.cfm?name=um-xl-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\" valign=\"top\">\n<td><span class=\"Bold\">Immunity tests</span></td><td><span class=\"Bold\">IEC 60601 test levels</span></td><td><span class=\"Bold\">Compliance level</span></td><td><span class=\"Bold\">Electromagnetic environment - guidelines </span></td>\n</tr>\n<tr class=\"Last\" valign=\"top\">\n<td>\n<p class=\"First\">Conducted HF disturbances in accordance with IEC 61000-4-6</p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p>Radiated HF disturbances in accordance with IEC 61000-4-3</p>\n</td><td>\n<p class=\"First\">3 V<br/>150 kHz to 80 MHz</p>\n<p></p>\n<p>6 V<br/>ISM bands 0.15 - 80 MHz<br/>80 % AM with 1 kHz</p>\n<p></p>\n<p>3 V/m 80 MHz to 2.7 GHz<br/>80 % AM with 1 kHz</p>\n</td><td>\n<p class=\"First\">3 V</p>\n<p></p>\n<p></p>\n<p></p>\n<p>6 V</p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p>3 V/m</p>\n</td><td>\n<p class=\"First\">Portable and mobile communication devices should not be used in closer proximity of the unit or its cables than the recommended safety distance of 300 mm.</p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p>Interference may occur in the vicinity of equipment marked with the following symbol.</p>\n<p>\n<img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-xl-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td>Comment 1: These guidelines may not be applicable in all cases. The propagation of electromagnetic values is influenced by absorptions and reflections of buildings, objects, and people.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td>Comment 1: These guidelines may not be applicable in all cases. The propagation of electromagnetic values is influenced by absorptions and reflections of buildings, objects, and people.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td> <p class="First">Recommended safety distances between portable and mobile HF telecommunication devices and the BF-RhodoLED<span class="Sup">®</span> </p> <p></p> </td> </tr> <tr class="Last"> <td> <p class="First">The BF-RhodoLED<span class="Sup">®</span> is intended for use in the electromagnetic environment in which the HF disturbances are controlled.</p> <p> <br/>The customer or operator of the device can help to avoid electromagnetic interference by maintaining the minimum safe distance between portable and mobile high-frequency telecommunication devices (transmitters) and the device. Portable RF communications equipment (radios, including their accessories such as antenna cables and external antennas) should not be used at a distance less than 30 cm (or 12 inches) from the manufacturer's specified parts and leads of the BF-RhodoLED<span class="Sup">®</span>. Failure to do so may result in a reduction in the performance of the device.</p> <p></p> <p>BF-RhodoLED<span class="Sup">®</span> should not be used directly alongside or between other electrical equipment.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td>\n<p class=\"First\">Recommended safety distances between portable and mobile HF telecommunication devices and the BF-RhodoLED<span class=\"Sup\">®</span>\n</p>\n<p></p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td>\n<p class=\"First\">The BF-RhodoLED<span class=\"Sup\">®</span> is intended for use in the electromagnetic environment in which the HF disturbances are controlled.</p>\n<p>\n<br/>The customer or operator of the device can help to avoid electromagnetic interference by maintaining the minimum safe distance between portable and mobile high-frequency telecommunication devices (transmitters) and the device. Portable RF communications equipment (radios, including their accessories such as antenna cables and external antennas) should not be used at a distance less than 30 cm (or 12 inches) from the manufacturer's specified parts and leads of the BF-RhodoLED<span class=\"Sup\">®</span>. Failure to do so may result in a reduction in the performance of the device.</p>\n<p></p>\n<p>BF-RhodoLED<span class=\"Sup\">®</span> should not be used directly alongside or between other electrical equipment.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td>Guidelines and manufacturer's declaration - proximity fields from RF wireless communication equipment</td> </tr> <tr class="Last"> <td> <p class="First">BF-RhodoLED<span class="Sup">®</span> is intended for operation in the electromagnetic environment detailed below.</p> <p>The customer or operator of the device should ensure that it is operated in this environment.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td>Guidelines and manufacturer's declaration - proximity fields from RF wireless communication equipment</td>\n</tr>\n<tr class=\"Last\">\n<td>\n<p class=\"First\">BF-RhodoLED<span class=\"Sup\">®</span> is intended for operation in the electromagnetic environment detailed below.</p>\n<p>The customer or operator of the device should ensure that it is operated in this environment.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td><span class="Bold">Service   </span></td><td><span class="Bold">Frequency range/ discrete frequencies MHz</span></td><td><span class="Bold">Compliance level</span> <br/> <span class="Bold">[V/m] </span></td> </tr> <tr> <td>TETRA 400</td><td align="center">390</td><td align="center">27</td> </tr> <tr> <td>GMRS 460, FRS 460</td><td align="center">430</td><td align="center">28</td> </tr> <tr> <td>LTE Band 13, 17</td><td align="center">734<br/>746<br/>788</td><td align="center">9</td> </tr> <tr> <td>GSM 800/900, TETRA 800,<br/>iDEN 820, CDMA,<br/>LTE Band 5</td><td align="center">821<br/>862<br/>948</td><td align="center">28</td> </tr> <tr> <td>GSM 1800, CDMA 1900,<br/>GSM 1900,DECT,<br/>LTE Band 1,3,4, 25</td><td align="center">1730<br/>1825<br/>1970</td><td align="center">28</td> </tr> <tr> <td>Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7</td><td align="center">2452</td><td align="center">28</td> </tr> <tr class="Last"> <td>WLAN 802.11<br/>a/n</td><td align="center">5240<br/>5500<br/>5700</td><td align="center">9</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><span class=\"Bold\">Service   </span></td><td><span class=\"Bold\">Frequency range/ discrete frequencies MHz</span></td><td><span class=\"Bold\">Compliance level</span>\n<br/>\n<span class=\"Bold\">[V/m] </span></td>\n</tr>\n<tr>\n<td>TETRA 400</td><td align=\"center\">390</td><td align=\"center\">27</td>\n</tr>\n<tr>\n<td>GMRS 460, FRS 460</td><td align=\"center\">430</td><td align=\"center\">28</td>\n</tr>\n<tr>\n<td>LTE Band 13, 17</td><td align=\"center\">734<br/>746<br/>788</td><td align=\"center\">9</td>\n</tr>\n<tr>\n<td>GSM 800/900, TETRA 800,<br/>iDEN 820, CDMA,<br/>LTE Band 5</td><td align=\"center\">821<br/>862<br/>948</td><td align=\"center\">28</td>\n</tr>\n<tr>\n<td>GSM 1800, CDMA 1900,<br/>GSM 1900,DECT,<br/>LTE Band 1,3,4, 25</td><td align=\"center\">1730<br/>1825<br/>1970</td><td align=\"center\">28</td>\n</tr>\n<tr>\n<td>Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7</td><td align=\"center\">2452</td><td align=\"center\">28</td>\n</tr>\n<tr class=\"Last\">\n<td>WLAN 802.11<br/>a/n</td><td align=\"center\">5240<br/>5500<br/>5700</td><td align=\"center\">9</td>\n</tr>\n</tbody>\n</table></div>" }

Version 2.7

{ "type": "p", "children": [], "text": "\nVersion 2.7\n" }

User Manual

{ "type": "p", "children": [], "text": "\nUser Manual\n" }

Manufacturer: Biofrontera Pharma GmbH Distributor: Biofrontera Inc.

{ "type": "p", "children": [], "text": "\nManufacturer: Biofrontera Pharma GmbH\n\nDistributor: Biofrontera Inc.\n" }

Foreword

{ "type": "p", "children": [], "text": "\n\nForeword\n" }

Thank you for choosing the RhodoLED® XL LED lamp for your photodynamic therapy. RhodoLED® XL has been developed in accordance with applicable technical standards to provide high energy efficiency as well as constant light emission at the desired wavelength.Your lamp must be installed and maintained by a qualified Biofrontera technician and used only in accordance with the instructions in this manual. You may request the latest printed version covering this model from Biofrontera at any time.

{ "type": "p", "children": [], "text": "Thank you for choosing the RhodoLED® XL LED lamp for your photodynamic therapy. RhodoLED® XL has been developed in accordance with applicable technical standards to provide high energy efficiency as well as constant light emission at the desired wavelength.Your lamp must be installed and maintained by a qualified Biofrontera technician and used only in accordance with the instructions in this manual. You may request the latest printed version covering this model from Biofrontera at any time." }

Our drug Ameluz® and medical device RhodoLED® XL have been approved in combination for photodynamic therapy; the only approved use of our lamp is in combination with Ameluz® gel. This user manual provides important RhodoLED® XL product details, precautions and warnings, and operating instructions. For Ameluz®, please use its US prescribing information. The Ameluz® prescribing information includes information on how to use the gel along with contraindications, warnings and precautions and dosage and administration.

{ "type": "p", "children": [], "text": "\nOur drug Ameluz® and medical device RhodoLED® XL have been approved in combination for photodynamic therapy; the only approved use of our lamp is in combination with Ameluz® gel. This user manual provides important RhodoLED® XL product details, precautions and warnings, and operating instructions. For Ameluz®, please use its US prescribing information. The Ameluz® prescribing information includes information on how to use the gel along with contraindications, warnings and precautions and dosage and administration." }

Thorough reading and use of both this user manual and the Ameluz® USPI is required prior to treatment.

{ "type": "p", "children": [], "text": "\nThorough reading and use of both this user manual and the Ameluz® USPI is required prior to treatment.\n" }

Our combination Ameluz®/RhodoLED® XL for photodynamic therapy is only to be used by physicians or healthcare professionals.

{ "type": "p", "children": [], "text": "\n\nOur combination Ameluz®/RhodoLED® XL for photodynamic therapy is only to be used by physicians or healthcare professionals.\n" }

For further questions about Ameluz®, RhodoLED® XL or the combination therapy please contact your sales representative or Biofrontera (Ameluz-US@biofrontera.com). See contact information below or visit us at http://www.biofrontera.us.com/

{ "type": "p", "children": [], "text": "For further questions about Ameluz®, RhodoLED® XL or the combination therapy please contact your sales representative or Biofrontera (Ameluz-US@biofrontera.com). See contact information below or visit us at http://www.biofrontera.us.com/" }

<div class="scrollingtable"><table border="1" cellpadding="5" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Underline">Sales representative:</span> </p> <p>Name:</p> <p>Tel.:</p> <p>E-mail:</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Biofrontera Inc</span>.</p> <p></p> <p>120 Presidential Way<br/>Suite 330<br/>Woburn, MA 01801<br/>USA<br/>Phone: (844) 426-3589</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"5\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Underline\">Sales representative:</span>\n</p>\n<p>Name:</p>\n<p>Tel.:</p>\n<p>E-mail:</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Biofrontera Inc</span>.</p>\n<p></p>\n<p>120 Presidential Way<br/>Suite 330<br/>Woburn, MA 01801<br/>USA<br/>Phone: (844) 426-3589</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Warranty and Disclaimers Please see the terms and conditions of your contract for this information.

{ "type": "p", "children": [], "text": "\nWarranty and Disclaimers\nPlease see the terms and conditions of your contract for this information." }

Manufacturer Biofrontera Pharma GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany

{ "type": "p", "children": [], "text": "\nManufacturer\nBiofrontera Pharma GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany" }

"AMELUZ and RHODOLED are registered trademarks of Biofrontera Pharma GmbH. ©2024 Biofrontera Pharma GmbH. All rights reserved.”

{ "type": "p", "children": [], "text": "\"AMELUZ and RHODOLED are registered trademarks of Biofrontera Pharma GmbH. ©2024 Biofrontera Pharma GmbH. All rights reserved.”" }

1 Intended Use

{ "type": "p", "children": [], "text": "\n1 Intended Use\n" }

RhodoLED® XL is a red light-emitting LED lamp, which is used exclusively in combination with Ameluz® gel for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.

{ "type": "p", "children": [], "text": "RhodoLED® XL is a red light-emitting LED lamp, which is used exclusively in combination with Ameluz® gel for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp." }

2 RhodoLED® XL - General Description

{ "type": "p", "children": [], "text": "\n\n2 RhodoLED® XL - General Description\n" }

RhodoLED® XL is comprised of three main components, the lamp head, an easily adjustable spring arm, and the mobile base with castors for smooth transport. In addition, the lamp has a convenient touchscreen monitor and aids for positioning the lamp head. The device is connected to the mains via a fixed mains supply cable.

{ "type": "p", "children": [], "text": "RhodoLED® XL is comprised of three main components, the lamp head, an easily adjustable spring arm, and the mobile base with castors for smooth transport. In addition, the lamp has a convenient touchscreen monitor and aids for positioning the lamp head. The device is connected to the mains via a fixed mains supply cable." }

3 Warnings and Precautions

{ "type": "p", "children": [], "text": "\n\n3 Warnings and Precautions\n" }

<div class="scrollingtable"><table cellpadding="5" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td><img alt="Symbol 08" src="/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The RhodoLED<span class="Sup">®</span> XL has been developed for use in photodynamic therapy in combination with Ameluz<span class="Sup">® </span>gel (excitation wavelength 635 nm). Any other use or combination of use is prohibited.</td> </tr> <tr> <td><img alt="Symbol 08" src="/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>During PDT side-effects such as application site erythema, pain, irritation, edema, pruritus, exfoliation, scab, induration and vesicles may occur. For further information please see Ameluz<span class="Sup">®</span> USPI chapter 6.</td> </tr> <tr> <td><img alt="Symbol 13" src="/dailymed/image.cfm?name=um-xl-symbol-13.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The user manual must be read carefully prior to using the RhodoLED<span class="Sup">®</span> XL.</td> </tr> <tr> <td><img alt="Symbol 08" src="/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The RhodoLED<span class="Sup">®</span> XL may only be used by healthcare professionals who have received adequate training in its use.</td> </tr> <tr> <td><img alt="Symbol 02" src="/dailymed/image.cfm?name=um-xl-symbol-02.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Bright light, do not stare into the light source</td> </tr> <tr> <td><img alt="Symbol 06" src="/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period.<br/>Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006.</td> </tr> <tr> <td><img alt="Symbol 10" src="/dailymed/image.cfm?name=um-xl-symbol-10.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td> <p class="First"> <img alt="Symbol 11" src="/dailymed/image.cfm?name=um-xl-symbol-11.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></p> <p>Distance sensor of RhodoLED<span class="Sup">®</span> XL is a class 1 laser product in compliance with IEC 60825-1:2014. A class 1 laser product is safe under all conditions of normal use.</p> </td> </tr> <tr> <td><img alt="Symbol 07" src="/dailymed/image.cfm?name=um-xl-symbol-07.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Risk of trapping fingers!<br/>Depending on positioning, fingers can be trapped<br/>between LED panels,<br/>between LED panels and the holding bracket,<br/>between the movable part and the fixed part of the lamp head holding bracket.</td> </tr> <tr> <td><img alt="Symbol 08" src="/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Neither the RhodoLED<span class="Sup">®</span> XL nor the power supply unit should be exposed to excessive mechanical stress or serviced by unauthorized personnel. Assembly and servicing may only be carried out by Biofrontera qualified professionals.</td> </tr> <tr> <td><img alt="Symbol 08" src="/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>In order to avoid the risk of electrical shock, the device may only be connected to a power supply with a grounded connection.</td> </tr> <tr> <td><img alt="Symbol 08" src="/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Neither the RhodoLED<span class="Sup">®</span> XL nor its control unit may come into contact with water as this may lead to severe damage or electrical shock (exception: cleaning with a damp cloth).</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The RhodoLED<span class="Sup">®</span> XL should be operated and housed indoors in areas with temperatures between 59 °F and 86 °F (15 °C and 30 °C), and relative humidity of 10 % to 90 %.</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Medical electronic devices require special precautionary measures with regard to the electro-magnetic compatibility (EMC); to avoid electro-magnetic disturbances, please do not place the device close to other electrical devices.</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>There is a risk of tripping over the power cord or the lamp base. When transporting or when device is not in use, unplug and keep the power cord rolled up.</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Ensure that the control unit is always returned to parking position to avoid damage during transport.</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The control unit should not be exposed to strong external pressure or sharp objects.</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>A person trained in operation of the RhodoLED<span class="Sup">®</span> XL must always be present during treatment.</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Before treating affected skin area with the topical medication check the proper functioning of the RhodoLED<span class="Sup">®</span> XL. Do not use a damaged device for treatment.</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>RhodoLED<span class="Sup">®</span> XL is intended for operation in non-residential facilities and such like that are connected directly to a public low-voltage supply network that also supplies residential buildings. RhodoLED<span class="Sup">®</span> XL shall be operated in environments of professional health care facilities except in the vicinity of RF surgical equipment and outside the RF-shielded room of a magnetic resonance imaging system</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The RhodoLED<span class="Sup">®</span> XL LED panels should only be used in curved shape and not in fully unfolded form. This is necessary to ensure the application of 37 J/cm² during the illumination.</td> </tr> <tr> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Do not place the device in such a way that it is difficult to disconnect the device's power plug from the mains during operation.</td> </tr> <tr class="Last"> <td><img alt="Symbol 12" src="/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>The device must be protected against unauthorized use.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"5\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><img alt=\"Symbol 08\" src=\"/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The RhodoLED<span class=\"Sup\">®</span> XL has been developed for use in photodynamic therapy in combination with Ameluz<span class=\"Sup\">® </span>gel (excitation wavelength 635 nm). Any other use or combination of use is prohibited.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 08\" src=\"/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>During PDT side-effects such as application site erythema, pain, irritation, edema, pruritus, exfoliation, scab, induration and vesicles may occur. For further information please see Ameluz<span class=\"Sup\">®</span> USPI chapter 6.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 13\" src=\"/dailymed/image.cfm?name=um-xl-symbol-13.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The user manual must be read carefully prior to using the RhodoLED<span class=\"Sup\">®</span> XL.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 08\" src=\"/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The RhodoLED<span class=\"Sup\">®</span> XL may only be used by healthcare professionals who have received adequate training in its use.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 02\" src=\"/dailymed/image.cfm?name=um-xl-symbol-02.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Bright light, do not stare into the light source</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 06\" src=\"/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period.<br/>Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 10\" src=\"/dailymed/image.cfm?name=um-xl-symbol-10.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>\n<p class=\"First\">\n<img alt=\"Symbol 11\" src=\"/dailymed/image.cfm?name=um-xl-symbol-11.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></p>\n<p>Distance sensor of RhodoLED<span class=\"Sup\">®</span> XL is a class 1 laser product in compliance with IEC 60825-1:2014. A class 1 laser product is safe under all conditions of normal use.</p>\n</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 07\" src=\"/dailymed/image.cfm?name=um-xl-symbol-07.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Risk of trapping fingers!<br/>Depending on positioning, fingers can be trapped<br/>between LED panels,<br/>between LED panels and the holding bracket,<br/>between the movable part and the fixed part of the lamp head holding bracket.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 08\" src=\"/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Neither the RhodoLED<span class=\"Sup\">®</span> XL nor the power supply unit should be exposed to excessive mechanical stress or serviced by unauthorized personnel. Assembly and servicing may only be carried out by Biofrontera qualified professionals.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 08\" src=\"/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>In order to avoid the risk of electrical shock, the device may only be connected to a power supply with a grounded connection.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 08\" src=\"/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Neither the RhodoLED<span class=\"Sup\">®</span> XL nor its control unit may come into contact with water as this may lead to severe damage or electrical shock (exception: cleaning with a damp cloth).</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The RhodoLED<span class=\"Sup\">®</span> XL should be operated and housed indoors in areas with temperatures between 59 °F and 86 °F (15 °C and 30 °C), and relative humidity of 10 % to 90 %.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Medical electronic devices require special precautionary measures with regard to the electro-magnetic compatibility (EMC); to avoid electro-magnetic disturbances, please do not place the device close to other electrical devices.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>There is a risk of tripping over the power cord or the lamp base. When transporting or when device is not in use, unplug and keep the power cord rolled up.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Ensure that the control unit is always returned to parking position to avoid damage during transport.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The control unit should not be exposed to strong external pressure or sharp objects.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>A person trained in operation of the RhodoLED<span class=\"Sup\">®</span> XL must always be present during treatment.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Before treating affected skin area with the topical medication check the proper functioning of the RhodoLED<span class=\"Sup\">®</span> XL. Do not use a damaged device for treatment.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>RhodoLED<span class=\"Sup\">®</span> XL is intended for operation in non-residential facilities and such like that are connected directly to a public low-voltage supply network that also supplies residential buildings. RhodoLED<span class=\"Sup\">®</span> XL shall be operated in environments of professional health care facilities except in the vicinity of RF surgical equipment and outside the RF-shielded room of a magnetic resonance imaging system</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The RhodoLED<span class=\"Sup\">®</span> XL LED panels should only be used in curved shape and not in fully unfolded form. This is necessary to ensure the application of 37 J/cm² during the illumination.</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Do not place the device in such a way that it is difficult to disconnect the device's power plug from the mains during operation.</td>\n</tr>\n<tr class=\"Last\">\n<td><img alt=\"Symbol 12\" src=\"/dailymed/image.cfm?name=um-xl-symbol-12.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>The device must be protected against unauthorized use.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table border="1" cellspacing="2" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td>Maintenance and initial set up of the RhodoLED<span class="Sup">®</span> XL must be carried out by authorized personnel. In the event of servicing or set up being carried out by any other party, Biofrontera assumes no responsibility or liability regarding the safety or use of the device.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellspacing=\"2\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td>Maintenance and initial set up of the RhodoLED<span class=\"Sup\">®</span> XL must be carried out by authorized personnel. In the event of servicing or set up being carried out by any other party, Biofrontera assumes no responsibility or liability regarding the safety or use of the device.</td>\n</tr>\n</tbody>\n</table></div>" }

4 RhodoLED® XL Technical Description

{ "type": "p", "children": [], "text": "\n4 RhodoLED® XL Technical Description\n" }

4.1 Light emitting diodes (LED)

{ "type": "p", "children": [], "text": "\n4.1 Light emitting diodes (LED)\n" }

RhodoLED® XL is a red-light emitting LED lamp, comprised of three main components, the lamp head, an easily adjustable spring arm, and the mobile base with castors for smooth transport. In addition, the lamp has a convenient touchscreen monitor and aids for positioning the lamp head. RhodoLED® XL has 45 LEDs per panel with a total of 5 panels (225 LEDs), which emit a uniform, visible red light. The typical peak wavelength is approximately 635 nm with a half-band width of 16 nm.

{ "type": "p", "children": [], "text": "RhodoLED® XL is a red-light emitting LED lamp, comprised of three main components, the lamp head, an easily adjustable spring arm, and the mobile base with castors for smooth transport. In addition, the lamp has a convenient touchscreen monitor and aids for positioning the lamp head. RhodoLED® XL has 45 LEDs per panel with a total of 5 panels (225 LEDs), which emit a uniform, visible red light. The typical peak wavelength is approximately 635 nm with a half-band width of 16 nm." }

Figure 1: LED panels with LED distribution and emission spectrum of RhodoLED® XL LEDs.

{ "type": "p", "children": [], "text": "\nFigure 1: LED panels with LED distribution and emission spectrum of RhodoLED® XL LEDs." }

The RhodoLED® XL LEDs are calibrated such that the skin being treated receives a light dose of approximately 37 J/cm2 under the following conditions:

{ "type": "p", "children": [], "text": "The RhodoLED® XL LEDs are calibrated such that the skin being treated receives a light dose of approximately 37 J/cm2 under the following conditions:" }

- Illumination time of 13.5 minutes

{ "type": "p", "children": [], "text": "- Illumination time of 13.5 minutes" }

- Treatment distance of 4.9 ± 0.6 inch (12.5 cm ± 1.5 cm)

{ "type": "p", "children": [], "text": "- Treatment distance of 4.9 ± 0.6 inch (12.5 cm ± 1.5 cm)" }

The illumination area of the LED lamp is 9.06 x 11.42 inch (23 cm x 29 cm) for all panels in a curved shape.

{ "type": "p", "children": [], "text": "The illumination area of the LED lamp is 9.06 x 11.42 inch (23 cm x 29 cm) for all panels in a curved shape." }

The LEDs are distributed on each panel in a specific way (see Figure 1), such that they are more densely packed towards the upper and lower edges than in the center region of each panel. This distribution optimizes the homogeneity of illumination over the treated skin.

{ "type": "p", "children": [], "text": "The LEDs are distributed on each panel in a specific way (see Figure 1), such that they are more densely packed towards the upper and lower edges than in the center region of each panel. This distribution optimizes the homogeneity of illumination over the treated skin." }

4.2 RhodoLED® XL Components

{ "type": "p", "children": [], "text": "\n\n4.2 RhodoLED® XL Components\n" }

The RhodoLED® XL consists of the following main components (Figure 2):

{ "type": "p", "children": [], "text": "The RhodoLED® XL consists of the following main components (Figure 2):" }

{ "type": "ul", "children": [ "Lamp head with telescope suspension", "Spring arm", "Control unit", "Mobile base (includes support rail, castors and power supply)" ], "text": "" }

Figure 2: RhodoLED® XL main components

{ "type": "p", "children": [], "text": "\nFigure 2: RhodoLED® XL main components" }

5 Operating environment of RhodoLED® XL

{ "type": "p", "children": [], "text": "\n5 Operating environment of RhodoLED® XL\n" }

RhodoLED® XL shall be operated in environments of professional health care facilities. For a detailed description in electromagnetic compatibility see chapter 15. RhodoLED® XL is intended for operation in non-residential facilities and such like that are connected directly to a public low-voltage supply network that also supplies residential buildings. 6 Eye Protection

{ "type": "p", "children": [], "text": "\nRhodoLED® XL shall be operated in environments of professional health care facilities. For a detailed description in electromagnetic compatibility see chapter 15. RhodoLED® XL is intended for operation in non-residential facilities and such like that are connected directly to a public low-voltage supply network that also supplies residential buildings.\n\n\n6 Eye Protection\n" }

Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare into the LED beam. RhodoLED® XL LEDs are classified in the exempt group product according to IEC 62471:2006. The operator and other persons present must wear protective glasses with a visible light transmission (VLT) of approximately 10 %. The patient must wear eye protection such as disposable eye protection pads or eye caps with an optical density for visible light of 6 or higher. Both options are effective and comfortable for use during treatment.

{ "type": "p", "children": [], "text": "Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare into the LED beam. RhodoLED® XL LEDs are classified in the exempt group product according to IEC 62471:2006. The operator and other persons present must wear protective glasses with a visible light transmission (VLT) of approximately 10 %. The patient must wear eye protection such as disposable eye protection pads or eye caps with an optical density for visible light of 6 or higher. Both options are effective and comfortable for use during treatment." }

Note: Eyewear is not part of the medical device. Please carefully read any accompanying usage information before using any eye protection.

{ "type": "p", "children": [], "text": "\n\nNote: Eyewear is not part of the medical device. Please carefully read any accompanying usage information before using any eye protection." }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td><img alt="Symbol 06" src="/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period.<br/>Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td><img alt=\"Symbol 06\" src=\"/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period.<br/>Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006.</td>\n</tr>\n</tbody>\n</table></div>" }

7 RhodoLED® XL PDT Summarized Step-by-Step Instruction

{ "type": "p", "children": [], "text": "\n\n7 RhodoLED® XL PDT Summarized Step-by-Step Instruction\n" }

These instructions should be used in conjunction with detailed operating instructions below (chapter 8). The section titles and numbers listed next to the instruction refer to the detailed instructions that correspond with each step.

{ "type": "p", "children": [], "text": "These instructions should be used in conjunction with detailed operating instructions below (chapter 8). The section titles and numbers listed next to the instruction refer to the detailed instructions that correspond with each step." }

Note: Every user of the RhodoLED® XL must be trained in operating the device. The initial training is provided by Biofrontera during set-up of the RhodoLED® XL. Recurrent training is not mandatory but can be provided by Biofrontera employees or other authorized parties. Before treating a patient with Ameluz®, please ensure that RhodoLED® XL is in good working order.

{ "type": "p", "children": [], "text": "\n\nNote: Every user of the RhodoLED® XL must be trained in operating the device. The initial training is provided by Biofrontera during set-up of the RhodoLED® XL. Recurrent training is not mandatory but can be provided by Biofrontera employees or other authorized parties. Before treating a patient with Ameluz®, please ensure that RhodoLED® XL is in good working order." }

<div class="scrollingtable"><table border="1 px" cellpadding="10" width="100%"> <tbody class="Headless"> <tr class="First"> <td valign="top">STEP 1)</td><td valign="top">Plug in the lamp.</td> </tr> <tr> <td valign="top">STEP 2)</td><td valign="top">Turn on the lamp and wait for the home screen to appear (see chapter 8.4.3).</td> </tr> <tr> <td valign="top">STEP 3)</td><td valign="top">Check the proper functioning of the RhodoLED<span class="Sup">®</span> XL.</td> </tr> <tr> <td valign="top">STEP 4)</td><td valign="top">Treat the affected skin area: Application, incubation, and removal of the topical medication according to the USPI of Ameluz<span class="Sup">®</span>.</td> </tr> <tr> <td valign="top">STEP 5)</td><td valign="top">Position the patient comfortably and equip the patient with protective eyewear (see chapter 6).</td> </tr> <tr> <td valign="top">STEP 6)</td><td valign="top">Select active panels (see chapter 8.4.5).</td> </tr> <tr> <td valign="top">STEP 7)</td><td valign="top">Position the lamp and adjust the lamp head over the skin area to be treated (distance 4.9 inch /12.5 cm) (see chapter 8.4.6).</td> </tr> <tr> <td valign="top">STEP 8)</td><td valign="top">Put on protective eyewear and make sure anyone remaining in the treatment room also wears protective eyewear (see chapter 6).</td> </tr> <tr> <td valign="top">STEP 9)</td><td valign="top">Start treatment by pressing <span class="Bold">Start</span>, the illumination period begins (see chapter 8.4.9).<br/>Remind the patient to remain still throughout the illumination period.<br/>If audible indicators during treatment are activated, explain the sounds to the patient.<br/>If the patient needs a break, press <span class="Bold">Pause</span> on the screen.<br/>To resume treatment, press <span class="Bold">Resume</span> (see chapter 8.4.10).<br/>To abort the illumination, press <span class="Bold">Cancel</span> (see chapter 8.4.10).<br/>Always stay with the patient during the illumination period.</td> </tr> <tr class="Last"> <td valign="top">STEP 10)</td><td valign="top">At the end of the illumination period, remove patient's protective eyewear and follow further instructions in the Ameluz<span class="Sup">®</span> USPI.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1 px\" cellpadding=\"10\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td valign=\"top\">STEP 1)</td><td valign=\"top\">Plug in the lamp.</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 2)</td><td valign=\"top\">Turn on the lamp and wait for the home screen to appear (see chapter 8.4.3).</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 3)</td><td valign=\"top\">Check the proper functioning of the RhodoLED<span class=\"Sup\">®</span> XL.</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 4)</td><td valign=\"top\">Treat the affected skin area: Application, incubation, and removal of the topical medication according to the USPI of Ameluz<span class=\"Sup\">®</span>.</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 5)</td><td valign=\"top\">Position the patient comfortably and equip the patient with protective eyewear (see chapter 6).</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 6)</td><td valign=\"top\">Select active panels (see chapter 8.4.5).</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 7)</td><td valign=\"top\">Position the lamp and adjust the lamp head over the skin area to be treated (distance 4.9 inch /12.5 cm) (see chapter 8.4.6).</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 8)</td><td valign=\"top\">Put on protective eyewear and make sure anyone remaining in the treatment room also wears protective eyewear (see chapter 6).</td>\n</tr>\n<tr>\n<td valign=\"top\">STEP 9)</td><td valign=\"top\">Start treatment by pressing <span class=\"Bold\">Start</span>, the illumination period begins (see chapter 8.4.9).<br/>Remind the patient to remain still throughout the illumination period.<br/>If audible indicators during treatment are activated, explain the sounds to the patient.<br/>If the patient needs a break, press <span class=\"Bold\">Pause</span> on the screen.<br/>To resume treatment, press <span class=\"Bold\">Resume</span> (see chapter 8.4.10).<br/>To abort the illumination, press <span class=\"Bold\">Cancel</span> (see chapter 8.4.10).<br/>Always stay with the patient during the illumination period.</td>\n</tr>\n<tr class=\"Last\">\n<td valign=\"top\">STEP 10)</td><td valign=\"top\">At the end of the illumination period, remove patient's protective eyewear and follow further instructions in the Ameluz<span class=\"Sup\">®</span> USPI.</td>\n</tr>\n</tbody>\n</table></div>" }

8 Detailed Operating Instructions

{ "type": "p", "children": [], "text": "\n\n8 Detailed Operating Instructions\n" }

Note: Every user of the RhodoLED® XL must be trained in operating the device. The initial training is provided by Biofrontera during set-up of the RhodoLED® XL. Recurrent training is not mandatory but can be provided by Biofrontera employees. The device must be protected against unauthorized use.

{ "type": "p", "children": [], "text": "\nNote: Every user of the RhodoLED® XL must be trained in operating the device. The initial training is provided by Biofrontera during set-up of the RhodoLED® XL. Recurrent training is not mandatory but can be provided by Biofrontera employees. The device must be protected against unauthorized use." }

<div class="scrollingtable"><table border="1" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td></td><td><img alt="Symbol 06" src="/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period.<br/>Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td></td><td><img alt=\"Symbol 06\" src=\"/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period.<br/>Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006.</td>\n</tr>\n</tbody>\n</table></div>" }

8.1 Transport of RhodoLED® XL and Spring Arm Lock Function

{ "type": "p", "children": [], "text": "\n\n8.1 Transport of RhodoLED® XL and Spring Arm Lock Function\n" }

During transportation the RhodoLED® XL must be in the transport position (see Figure 3). For the transport position the spring arm is moved down as far as possible and the locking bolt at the joint between head and spring is moved to the right (Figure 3). In this position, the spring arm is locked and cannot be moved upwards. To release the spring arm lock, push the locking bolt to the left (Figure 3). The locking function is located at the bottom of the spring arm, close to the lamp head connection.

{ "type": "p", "children": [], "text": "During transportation the RhodoLED® XL must be in the transport position (see Figure 3). For the transport position the spring arm is moved down as far as possible and the locking bolt at the joint between head and spring is moved to the right (Figure 3). In this position, the spring arm is locked and cannot be moved upwards. To release the spring arm lock, push the locking bolt to the left (Figure 3). The locking function is located at the bottom of the spring arm, close to the lamp head connection." }

For transport, please ensure that the control unit of RhodoLED® XL is placed on the left side (see Figure 3).

{ "type": "p", "children": [], "text": "\nFor transport, please ensure that the control unit of RhodoLED® XL is placed on the left side (see Figure 3)." }

Figure 3: Transport position of RhodoLED® XL and locking function of spring arm. Locking function is located at the bottom of the spring arm, close to the lamp head connection.

{ "type": "p", "children": [], "text": "\nFigure 3: Transport position of RhodoLED® XL and locking function of spring arm. Locking function is located at the bottom of the spring arm, close to the lamp head connection." }

8.2 Movement Areas

{ "type": "p", "children": [], "text": "\n8.2 Movement Areas\n" }

The swivel range of the spring arm to the left and right of the main axis is +/- 5°. The vertical range of the spring arm is 68°. The spring arm with internal gas spring allows seamless adjustment to any height. The lamp head can be rotated by 360° (Figure 4). In addition, the panels can be tilted up to 90° at the holding bracket (Figure 4).

{ "type": "p", "children": [], "text": "The swivel range of the spring arm to the left and right of the main axis is +/- 5°. The vertical range of the spring arm is 68°. The spring arm with internal gas spring allows seamless adjustment to any height. The lamp head can be rotated by 360° (Figure 4). In addition, the panels can be tilted up to 90° at the holding bracket (Figure 4)." }

Note: If the spring arm is at the top, it may collide with the LED panels when they are rotated 360°.

{ "type": "p", "children": [], "text": "\nNote: If the spring arm is at the top, it may collide with the LED panels when they are rotated 360°.\n" }

Figure 4: Rotation and tilting of the lamp head.

{ "type": "p", "children": [], "text": "\nFigure 4: Rotation and tilting of the lamp head." }

The orientation of the panels can be changed from a curved shape to an unfolded form by pulling the holding bracket apart (Figure 5).

{ "type": "p", "children": [], "text": "The orientation of the panels can be changed from a curved shape to an unfolded form by pulling the holding bracket apart (Figure 5)." }

Figure 5: Movement range of the lamp head.

{ "type": "p", "children": [], "text": "\nFigure 5: Movement range of the lamp head." }

Note: The RhodoLED® XL LED panels should only be used in curved shape and not in a fully unfolded form. This is necessary to ensure the application of 37 J/cm² during the illumination.

{ "type": "p", "children": [], "text": "\nNote: The RhodoLED® XL LED panels should only be used in curved shape and not in a fully unfolded form. This is necessary to ensure the application of 37 J/cm² during the illumination.\n" }

The control unit can be turned from the left to the right side of the device (see Figure 6). The control unit must be brought completely into the selected position until it snaps into place.

{ "type": "p", "children": [], "text": "The control unit can be turned from the left to the right side of the device (see Figure 6). The control unit must be brought completely into the selected position until it snaps into place." }

Note: If the control unit is not snapped into position, there may be a collision between the spring arm and the control unit.

{ "type": "p", "children": [], "text": "\n\nNote: If the control unit is not snapped into position, there may be a collision between the spring arm and the control unit.\n" }

Figure 6: Control unit positions

{ "type": "p", "children": [], "text": "\nFigure 6: Control unit positions" }

8.3 Turning RhodoLED® XL On and Off

{ "type": "p", "children": [], "text": "\n8.3 Turning RhodoLED® XL On and Off \n" }

Note: Before turning on the lamp, the power cord must be plugged in into the power grid. RhodoLED® XL is intended for operation in non-residential facilities and such like that are connected directly to a public low-voltage supply network that also supplies residential buildings.

{ "type": "p", "children": [], "text": "\nNote: Before turning on the lamp, the power cord must be plugged in into the power grid. RhodoLED® XL is intended for operation in non-residential facilities and such like that are connected directly to a public low-voltage supply network that also supplies residential buildings." }

Note: Do not place the device in such a way that it is difficult to disconnect the device's power plug from the mains during operation.

{ "type": "p", "children": [], "text": "\n\nNote: Do not place the device in such a way that it is difficult to disconnect the device's power plug from the mains during operation." }

The RhodoLED® XL is equipped with a cable winding system. To unwind the cable, pull the plug out of the opening of the lamp base. When the cable is being unwound, a clicking sound is heard. The power button is located on the right side of the control unit. With the lamp plugged in, press the power button to start the device.

{ "type": "p", "children": [], "text": "\nThe RhodoLED® XL is equipped with a cable winding system. To unwind the cable, pull the plug out of the opening of the lamp base. When the cable is being unwound, a clicking sound is heard. The power button is located on the right side of the control unit. With the lamp plugged in, press the power button to start the device." }

To power down the device, press the power button and the device shuts down. RhodoLED® XL can also be switched off via the software. To switch the device off, press the software power button in the upper right corner. To rewind the cable, remove the plug from the wall socket and slightly pull on the cable once. Hold the cable loosely in your hand to allow rewinding. The cable winder will pull the cable in automatically until it is fully rolled up. Do not completely release the cable when winding it up to avoid damage of the device.

{ "type": "p", "children": [], "text": "\nTo power down the device, press the power button and the device shuts down. RhodoLED® XL can also be switched off via the software. To switch the device off, press the software power button in the upper right corner. To rewind the cable, remove the plug from the wall socket and slightly pull on the cable once. Hold the cable loosely in your hand to allow rewinding. The cable winder will pull the cable in automatically until it is fully rolled up. Do not completely release the cable when winding it up to avoid damage of the device." }

Figure 7: Control unit of RhodoLED® XL with power button

{ "type": "p", "children": [], "text": "\nFigure 7: Control unit of RhodoLED® XL with power button" }

8.4 RhodoLED® XL Controls

{ "type": "p", "children": [], "text": "\n\n8.4 RhodoLED® XL Controls\n" }

8.4.1 Control Unit

{ "type": "p", "children": [], "text": "\n8.4.1 Control Unit\n" }

The touchscreen of the control unit can be used while wearing commercially available examination gloves.

{ "type": "p", "children": [], "text": "The touchscreen of the control unit can be used while wearing commercially available examination gloves." }

8.4.2 Splash Screen

{ "type": "p", "children": [], "text": "\n8.4.2 Splash Screen\n" }

The Biofrontera corporate logo and software version are displayed during the LED lamp operating system start-up (Figure 8). The operating system takes approximately 10 seconds to load.

{ "type": "p", "children": [], "text": "The Biofrontera corporate logo and software version are displayed during the LED lamp operating system start-up (Figure 8). The operating system takes approximately 10 seconds to load." }

Figure 8: Splash screen

{ "type": "p", "children": [], "text": "\nFigure 8: Splash screen" }

8.4.3 Home Screen

{ "type": "p", "children": [], "text": "\n\n8.4.3 Home Screen\n" }

The home screen appears after the operating system has loaded.

{ "type": "p", "children": [], "text": "The home screen appears after the operating system has loaded." }

Figure 9: Home screen

{ "type": "p", "children": [], "text": "\nFigure 9: Home screen" }

8.4.4 The Treatment Profile

{ "type": "p", "children": [], "text": "\n8.4.4 The Treatment Profile\n" }

The RhodoLED® XL has a fixed LED light intensity which ensures the application of 37 J/cm² within the 13.5-minute treatment time.

{ "type": "p", "children": [], "text": "The RhodoLED® XL has a fixed LED light intensity which ensures the application of 37 J/cm² within the 13.5-minute treatment time." }

8.4.5 Selecting Active LED Panels

{ "type": "p", "children": [], "text": "\n8.4.5 Selecting Active LED Panels\n" }

The device has 5 LED panels which are also displayed by the software (Figure 10). The illustrated panels are visible from the back side and the corresponding panel of the device can be identified via the handles, starting from the left. All panels are activated by default and can be deactivated via the software. To deactivate LED panels, press on the illustrated panel. For easier orientation, the panel number can also be found at the backside of the respective panel (Figure 11).

{ "type": "p", "children": [], "text": "The device has 5 LED panels which are also displayed by the software (Figure 10). The illustrated panels are visible from the back side and the corresponding panel of the device can be identified via the handles, starting from the left. All panels are activated by default and can be deactivated via the software. To deactivate LED panels, press on the illustrated panel. For easier orientation, the panel number can also be found at the backside of the respective panel (Figure 11)." }

Figure 10: Software illustration of RhodoLED® XL LED panels (all panels are activated)

{ "type": "p", "children": [], "text": "\nFigure 10: Software illustration of RhodoLED® XL LED panels (all panels are activated)" }

Figure 11: Panel number at the backside of the panel

{ "type": "p", "children": [], "text": "\nFigure 11: Panel number at the backside of the panel" }

Deactivated panels are displayed in grey with a power symbol in their centers (Figure 12). Activated panels are highlighted and the current distance to the treatment area is displayed.

{ "type": "p", "children": [], "text": "Deactivated panels are displayed in grey with a power symbol in their centers (Figure 12). Activated panels are highlighted and the current distance to the treatment area is displayed." }

Figure 12: Coloring of a switched off panel

{ "type": "p", "children": [], "text": "\n\nFigure 12: Coloring of a switched off panel" }

8.4.6 Treatment Area

{ "type": "p", "children": [], "text": "\n\n8.4.6 Treatment Area\n" }

The illumination area of RhodoLED® XL is 9.06 x 11.42 inch (23 cm x 29 cm) when all panels are arranged in the standard curved shape. This usually allows a full-face illumination. However, face and head sizes are subject to strong variations between patients. As a rough guidance, the midlines of the outer two panels marks the outer boundaries of the illumination area (see Figure 13 as guidance).

{ "type": "p", "children": [], "text": "The illumination area of RhodoLED® XL is 9.06 x 11.42 inch (23 cm x 29 cm) when all panels are arranged in the standard curved shape. This usually allows a full-face illumination. However, face and head sizes are subject to strong variations between patients. As a rough guidance, the midlines of the outer two panels marks the outer boundaries of the illumination area (see Figure 13 as guidance)." }

Note: The RhodoLED® XL LED panels should only be used in curved shape and not in fully unfolded form. This is necessary to ensure the application of 37 J/cm² during the illumination.

{ "type": "p", "children": [], "text": "\nNote: The RhodoLED® XL LED panels should only be used in curved shape and not in fully unfolded form. This is necessary to ensure the application of 37 J/cm² during the illumination.\n" }

Figure 13: Treatment area of RhodoLED® XL from the side and in top view.

{ "type": "p", "children": [], "text": "\nFigure 13: Treatment area of RhodoLED® XL from the side and in top view." }

Note: If less than 5 panels are used for a treatment, it must be ensured that at least three adjacent panels are used. The treatment area is thereby reduced and reaches from the midline of the one outer panel to the other midline of the other outer panel.

{ "type": "p", "children": [], "text": "\nNote: If less than 5 panels are used for a treatment, it must be ensured that at least three adjacent panels are used. The treatment area is thereby reduced and reaches from the midline of the one outer panel to the other midline of the other outer panel.\n" }

If a treatment with less than 5 active LED panels is started, a message dialog appears which must be confirmed.

{ "type": "p", "children": [], "text": "\nIf a treatment with less than 5 active LED panels is started, a message dialog appears which must be confirmed." }

8.4.7 Adjusting the Treatment Distance

{ "type": "p", "children": [], "text": "\n8.4.7 Adjusting the Treatment Distance\n" }

The correct treatment distance for the RhodoLED® XL is 4.9 ± 0.6 inch (12.5 ± 1.5 cm). Each LED panel is equipped with a distance sensor to allow individual adjustment of all panels. The distance sensor is automatically switched on if the panel is switched on. The current distance of each panel is shown on the control unit display above the panel illustration. The following table summarizes the visualization of the treatment distance.

{ "type": "p", "children": [], "text": "The correct treatment distance for the RhodoLED® XL is 4.9 ± 0.6 inch (12.5 ± 1.5 cm). Each LED panel is equipped with a distance sensor to allow individual adjustment of all panels. The distance sensor is automatically switched on if the panel is switched on. The current distance of each panel is shown on the control unit display above the panel illustration. The following table summarizes the visualization of the treatment distance." }

Note: When starting the treatment, the LED panels that are too close or too far away from the treatment area will nevertheless also light up. To disable an LED panel during the treatment it must be switched off on the display (see Figure 12).

{ "type": "p", "children": [], "text": "\nNote: When starting the treatment, the LED panels that are too close or too far away from the treatment area will nevertheless also light up. To disable an LED panel during the treatment it must be switched off on the display (see Figure 12).\n" }

Table 1: Adjusting the treatment distance

{ "type": "p", "children": [], "text": "\nTable 1: Adjusting the treatment distance" }

<div class="scrollingtable"><table cellpadding="10" width="100%"> <tbody class="Headless"> <tr class="First"> <td><span class="Bold">Pictogram</span></td><td><span class="Bold">Meaning</span></td> </tr> <tr> <td><img alt="Symbol 03" src="/dailymed/image.cfm?name=um-xl-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Treatment distance is correct for this LED panel (4.9 ± 0.6 inch / 12.5 ± 1.5 cm), adjustment light is/turns on</td> </tr> <tr> <td><img alt="Symbol 01" src="/dailymed/image.cfm?name=um-xl-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Treatment distance is too small for this LED panel. LED panel must be further away from treatment area, adjustment light is/turns off</td> </tr> <tr> <td><img alt="Symbol 04" src="/dailymed/image.cfm?name=um-xl-symbol-04.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Treatment distance is too large for this LED panel. LED panel must be closer to the treatment area, adjustment light is/turns off</td> </tr> <tr class="Last"> <td><img alt="Symbol 15" src="/dailymed/image.cfm?name=um-xl-symbol-15.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>This LED panel is switched off</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"10\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><span class=\"Bold\">Pictogram</span></td><td><span class=\"Bold\">Meaning</span></td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 03\" src=\"/dailymed/image.cfm?name=um-xl-symbol-03.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Treatment distance is correct for this LED panel (4.9 ± 0.6 inch / 12.5 ± 1.5 cm), adjustment light is/turns on</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 01\" src=\"/dailymed/image.cfm?name=um-xl-symbol-01.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Treatment distance is too small for this LED panel. LED panel must be further away from treatment area, adjustment light is/turns off</td>\n</tr>\n<tr>\n<td><img alt=\"Symbol 04\" src=\"/dailymed/image.cfm?name=um-xl-symbol-04.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Treatment distance is too large for this LED panel. LED panel must be closer to the treatment area, adjustment light is/turns off</td>\n</tr>\n<tr class=\"Last\">\n<td><img alt=\"Symbol 15\" src=\"/dailymed/image.cfm?name=um-xl-symbol-15.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>This LED panel is switched off</td>\n</tr>\n</tbody>\n</table></div>" }

8.4.8 Adjustment Light

{ "type": "p", "children": [], "text": "\n8.4.8 Adjustment Light\n" }

If the correct treatment distance of 4.9 inch (12.5 cm) is set the LEDs of the panel light up at a low light intensity to allow an easy adjustment of the distance and the target treatment area.

{ "type": "p", "children": [], "text": "If the correct treatment distance of 4.9 inch (12.5 cm) is set the LEDs of the panel light up at a low light intensity to allow an easy adjustment of the distance and the target treatment area." }

The size of the treatment area is 9.06 x 11.42 inch (23 cm x 29 cm) for all panels in a curved shape.

{ "type": "p", "children": [], "text": "\nThe size of the treatment area is 9.06 x 11.42 inch (23 cm x 29 cm) for all panels in a curved shape." }

Note: When starting the treatment, the LED panels that are too close or too far away from the treatment area will nevertheless also light up. To disable an LED panel during the treatment it must be switched off on the display (see Figure 12).

{ "type": "p", "children": [], "text": "\n\nNote: When starting the treatment, the LED panels that are too close or too far away from the treatment area will nevertheless also light up. To disable an LED panel during the treatment it must be switched off on the display (see Figure 12).\n" }

Figure 14: Low light intensity for correct adjustment of LED panels.

{ "type": "p", "children": [], "text": "\nFigure 14: Low light intensity for correct adjustment of LED panels." }

8.4.9 Starting an Illumination

{ "type": "p", "children": [], "text": "\n8.4.9 Starting an Illumination\n" }

To start a treatment, press the Start button. Before starting the treatment make sure every person present wears the correct eye protection (see chapter 6) and confirm the query for eye protection (Figure 15).

{ "type": "p", "children": [], "text": "To start a treatment, press the Start button. Before starting the treatment make sure every person present wears the correct eye protection (see chapter 6) and confirm the query for eye protection (Figure 15)." }

<div class="scrollingtable"><table cellpadding="10" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td><img alt="Symbol 06" src="/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period.<br/>Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"10\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td><img alt=\"Symbol 06\" src=\"/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period.<br/>Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006.</td>\n</tr>\n</tbody>\n</table></div>" }

Figure 15: Note on eye protection before starting treatment.

{ "type": "p", "children": [], "text": "\nFigure 15: Note on eye protection before starting treatment." }

During the illumination, the remaining treatment time is displayed in the diagram. The progress is marked green in the profile and with a green dotted vertical line (Figure 16).

{ "type": "p", "children": [], "text": "During the illumination, the remaining treatment time is displayed in the diagram. The progress is marked green in the profile and with a green dotted vertical line (Figure 16)." }

Figure 16: Treatment progress.

{ "type": "p", "children": [], "text": "\nFigure 16: Treatment progress." }

8.4.10 Pause, continue, or cancel a treatment

{ "type": "p", "children": [], "text": "\n8.4.10 Pause, continue, or cancel a treatment\n" }

Figure 17: Pause, continue, and cancel a treatment.

{ "type": "p", "children": [], "text": "\nFigure 17: Pause, continue, and cancel a treatment." }

To abort the current treatment, press the Cancel button. The applied light dose and the remaining treatment time is displayed in a query. Confirm the query to cancel the treatment (Figure 18).

{ "type": "p", "children": [], "text": "\nTo abort the current treatment, press the Cancel button. The applied light dose and the remaining treatment time is displayed in a query. Confirm the query to cancel the treatment (Figure 18)." }

Figure 18: Cancelled treatment message shows applied light dose and remaining treatment time.

{ "type": "p", "children": [], "text": "\nFigure 18: Cancelled treatment message shows applied light dose and remaining treatment time." }

Note: If you cancel prior to the end of the total treatment time, the internal timer will reset. The remaining treatment time will not be saved.

{ "type": "p", "children": [], "text": "\nNote: If you cancel prior to the end of the total treatment time, the internal timer will reset. The remaining treatment time will not be saved.\n" }

After pressing Cancel and Yes or upon completion of the treatment the software will automatically return to the home screen.

{ "type": "p", "children": [], "text": "After pressing Cancel and Yes or upon completion of the treatment the software will automatically return to the home screen." }

8.4.11 Audio Signals After Treatment

{ "type": "p", "children": [], "text": "\n8.4.11 Audio Signals After Treatment\n" }

After completion of the treatment a signal occurs, and the lamp will stop the illumination. Audio signals can be deactivated via the settings menu (see chapter 8.5.4).

{ "type": "p", "children": [], "text": "\nAfter completion of the treatment a signal occurs, and the lamp will stop the illumination. Audio signals can be deactivated via the settings menu (see chapter 8.5.4).\n" }

Further audio signals occur for queries that must be confirmed and may occur in the event of an error. A description of possible errors can be found in chapter 9.

{ "type": "p", "children": [], "text": "\nFurther audio signals occur for queries that must be confirmed and may occur in the event of an error. A description of possible errors can be found in chapter 9." }

8.5 Settings Menu

{ "type": "p", "children": [], "text": "\n\n\n8.5 Settings Menu\n" }

<div class="scrollingtable"><table cellpadding="10" width="100%"> <tbody class="Headless"> <tr class="First First Last Last"> <td><img alt="Symbol 17" src="/dailymed/image.cfm?name=um-xl-symbol-17.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>To open the settings menu, select the gear symbol in the upper right corner of the screen.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"10\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td><img alt=\"Symbol 17\" src=\"/dailymed/image.cfm?name=um-xl-symbol-17.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>To open the settings menu, select the gear symbol in the upper right corner of the screen.</td>\n</tr>\n</tbody>\n</table></div>" }

The settings menu is organized in the tabs General, Service and Info.

{ "type": "p", "children": [], "text": "The settings menu is organized in the tabs General, Service and Info." }

Figure 19: The settings menu is organized in the three main tabs General, Service and Info

{ "type": "p", "children": [], "text": "\nFigure 19: The settings menu is organized in the three main tabs General, Service and Info\n" }

8.5.1 Language

{ "type": "p", "children": [], "text": "\n\n8.5.1 Language\n" }

Language settings are part of the General settings tab. Select a language by tapping on the left and right arrows. The software provides the languages English, Spanish and German.

{ "type": "p", "children": [], "text": "Language settings are part of the General settings tab. Select a language by tapping on the left and right arrows. The software provides the languages English, Spanish and German." }

Confirm the selected language by pressing the Save button, to discard the settings leave the menu without pressing Save.

{ "type": "p", "children": [], "text": "Confirm the selected language by pressing the Save button, to discard the settings leave the menu without pressing Save." }

8.5.2 Distance Units

{ "type": "p", "children": [], "text": "\n\n8.5.2 Distance Units\n" }

Unit settings are part of the General settings tab. The distance of the LED panels to the treatment area can be displayed in inch or in cm. Select a distance unit by tapping on the arrows.

{ "type": "p", "children": [], "text": "Unit settings are part of the General settings tab. The distance of the LED panels to the treatment area can be displayed in inch or in cm. Select a distance unit by tapping on the arrows." }

Confirm the selected distance unit by pressing the Save button, to discard the settings leave the menu without pressing Save.

{ "type": "p", "children": [], "text": "\nConfirm the selected distance unit by pressing the Save button, to discard the settings leave the menu without pressing Save." }

8.5.3 Auto power off

{ "type": "p", "children": [], "text": "\n8.5.3 Auto power off\n" }

Auto power off settings are part of the General settings tab. The auto power off setting is used to set the time after which the lamp is automatically switched off. Values of 15, 30, 60 and 120 minutes can be selected.

{ "type": "p", "children": [], "text": "Auto power off settings are part of the General settings tab. The auto power off setting is used to set the time after which the lamp is automatically switched off. Values of 15, 30, 60 and 120 minutes can be selected." }

Confirm your selected auto power off time by pressing Save, to discard the settings leave the menu without pressing Save.

{ "type": "p", "children": [], "text": "\nConfirm your selected auto power off time by pressing Save, to discard the settings leave the menu without pressing Save." }

8.5.4 Sound Settings

{ "type": "p", "children": [], "text": "\n8.5.4 Sound Settings\n" }

Sound settings are part of the General settings tab. Activate and deactivate the audio signals for typing and sounds during the treatment. To do this, activate or deactivate the corresponding sliding switch. A green slider means the sound is currently switched on.

{ "type": "p", "children": [], "text": "Sound settings are part of the General settings tab. Activate and deactivate the audio signals for typing and sounds during the treatment. To do this, activate or deactivate the corresponding sliding switch. A green slider means the sound is currently switched on." }

Confirm your selection by pressing Save, to discard the settings leave the menu without pressing Save.

{ "type": "p", "children": [], "text": "\nConfirm your selection by pressing Save, to discard the settings leave the menu without pressing Save." }

Note: Warning sounds will be emitted if an error occurs during operation of the lamp. Warning sounds cannot be turned off.

{ "type": "p", "children": [], "text": "\n\nNote: Warning sounds will be emitted if an error occurs during operation of the lamp. Warning sounds cannot be turned off.\n" }

8.5.5 Info-Tab

{ "type": "p", "children": [], "text": "\n\n8.5.5 Info-Tab\n" }

The system status provides information about the current hardware and software status of the device.

{ "type": "p", "children": [], "text": "The system status provides information about the current hardware and software status of the device." }

This includes information about:

{ "type": "p", "children": [], "text": "This includes information about:" }

• The serial numbers of the systems core components• Automatic switch off settings • Software version • List of occurred errors (chapter 9)

{ "type": "p", "children": [], "text": "\n • The serial numbers of the systems core components• Automatic switch off settings • Software version • List of occurred errors (chapter 9)" }

Note: In case of a malfunction of the device, please have this information available.

{ "type": "p", "children": [], "text": "\n\nNote: In case of a malfunction of the device, please have this information available.\n" }

8.5.6 Service Menu

{ "type": "p", "children": [], "text": "\n\n8.5.6 Service Menu\n" }

<div class="scrollingtable"><table cellpadding="10" width="100%"> <tbody class="Headless"> <tr class="First First Last Last"> <td><img alt="Symbol 16" src="/dailymed/image.cfm?name=um-xl-symbol-16.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td>Authorization is required to access the service menu. Only authorized personnel can access the service menu. See also chapter 10.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"10\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td><img alt=\"Symbol 16\" src=\"/dailymed/image.cfm?name=um-xl-symbol-16.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td>Authorization is required to access the service menu. Only authorized personnel can access the service menu. See also chapter 10.</td>\n</tr>\n</tbody>\n</table></div>" }

9 Error Messages

{ "type": "p", "children": [], "text": "\n\n9 Error Messages\n" }

The RhodoLED® XL has an integrated monitoring function. In the event of a malfunction, an error message will appear in the message display. Possible error messages are set out in the table below. Please ensure that you always correctly record the error code when contacting Biofrontera customer service in case of an error message.

{ "type": "p", "children": [], "text": "The RhodoLED® XL has an integrated monitoring function. In the event of a malfunction, an error message will appear in the message display. Possible error messages are set out in the table below. Please ensure that you always correctly record the error code when contacting Biofrontera customer service in case of an error message." }

Note: even if usage of the lamp is still possible in case of an error, please contact your local sales representative or Biofrontera if an error message persists.

{ "type": "p", "children": [], "text": "\nNote: even if usage of the lamp is still possible in case of an error, please contact your local sales representative or Biofrontera if an error message persists.\n" }

<div class="scrollingtable"><table border="1" cellpadding="2" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Error code</span></td><td class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Possible causes</span></td><td class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Measures</span></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">001 System error</td><td class="Botrule Lrule Rrule Toprule" valign="top">Error in system of the device</td><td class="Botrule Lrule Rrule Toprule" valign="top">- Confirm the system error<br/>- Please contact your local sales representative or Biofrontera</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">002 Communication error</td><td class="Botrule Lrule Rrule Toprule" valign="top">Communication between the control unit and the LED panels disturbed</td><td class="Botrule Lrule Rrule Toprule" valign="top">- Confirm the communication error<br/>- Treatment can be continued by confirming the message dialog<br/>- Please contact your local sales representative or Biofrontera<br/>- If there is a permanent error in the communication, no further treatment is possible</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">003 Panel error</p> <p> <img alt="Symbol 14" src="/dailymed/image.cfm?name=um-xl-symbol-14.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></p> </td><td class="Botrule Lrule Rrule Toprule" valign="top">Error in the control of one or more LED panel<br/>Defective LED panels are marked with a red triangle</td><td class="Botrule Lrule Rrule Toprule" valign="top">- Confirm the Panel error<br/>- Treatment can be continued by confirming the message dialog<br/>- Please contact your local sales representative or Biofrontera</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">004 Distance sensor error</td><td class="Botrule Lrule Rrule Toprule" valign="top">Error in control of the distance sensors</td><td class="Botrule Lrule Rrule Toprule" valign="top">- Confirm the Distance sensor error<br/>- Treatment can be continued by confirming the message dialog<br/>- Please contact your local sales representative or Biofrontera</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">005 Update process error</td><td class="Botrule Lrule Rrule Toprule" valign="top">The software needs updating</td><td class="Botrule Lrule Rrule Toprule" valign="top">- Please contact your local sales representative or Biofrontera</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">006 Temperature sensor error</td><td class="Botrule Lrule Rrule Toprule" valign="top">Defective temperature sensor of defect in temperature sensor control</td><td class="Botrule Lrule Rrule Toprule" valign="top">- Confirm the Distance sensor error<br/>- Treatment can be continued by confirming the message dialog<br/>- Please contact your local sales representative or Biofrontera</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top">007 Cooling system error</td><td class="Botrule Lrule Rrule Toprule" valign="top">The ventilators or ventilator slots are blocked<br/>The air inlets or outlets are adversely affected</td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">- Check the ventilators and test the air inlets and outlets</p> <p>- Remove any visible foreign objects which may be present<br/>- In case of continuing impairment of the cooling system, please contact your local sales representative or Biofrontera</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top">The treatment is paused due to an overheated LED panel. Wait until normal temperature is reached.</td><td class="Botrule Lrule Rrule Toprule" valign="top">The temperature is too high</td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">- Wait until the standard temperature has been reached</p> <p>- Treatment can then be resumed</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"2\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Error code</span></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Possible causes</span></td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Measures</span></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">001 System error</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Error in system of the device</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">- Confirm the system error<br/>- Please contact your local sales representative or Biofrontera</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">002 Communication error</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Communication between the control unit and the LED panels disturbed</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">- Confirm the communication error<br/>- Treatment can be continued by confirming the message dialog<br/>- Please contact your local sales representative or Biofrontera<br/>- If there is a permanent error in the communication, no further treatment is possible</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">003 Panel error</p>\n<p>\n<img alt=\"Symbol 14\" src=\"/dailymed/image.cfm?name=um-xl-symbol-14.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Error in the control of one or more LED panel<br/>Defective LED panels are marked with a red triangle</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">- Confirm the Panel error<br/>- Treatment can be continued by confirming the message dialog<br/>- Please contact your local sales representative or Biofrontera</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">004 Distance sensor error</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Error in control of the distance sensors</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">- Confirm the Distance sensor error<br/>- Treatment can be continued by confirming the message dialog<br/>- Please contact your local sales representative or Biofrontera</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">005 Update process error</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">The software needs updating</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">- Please contact your local sales representative or Biofrontera</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">006 Temperature sensor error</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Defective temperature sensor of defect in temperature sensor control</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">- Confirm the Distance sensor error<br/>- Treatment can be continued by confirming the message dialog<br/>- Please contact your local sales representative or Biofrontera</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">007 Cooling system error</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">The ventilators or ventilator slots are blocked<br/>The air inlets or outlets are adversely affected</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">- Check the ventilators and test the air inlets and outlets</p>\n<p>- Remove any visible foreign objects which may be present<br/>- In case of continuing impairment of the cooling system, please contact your local sales representative or Biofrontera</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">The treatment is paused due to an overheated LED panel. Wait until normal temperature is reached.</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">The temperature is too high</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">- Wait until the standard temperature has been reached</p>\n<p>- Treatment can then be resumed</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

If your RhodoLED® XL no longer functions properly for some unknown reason, proceed as follows:

{ "type": "p", "children": [], "text": "If your RhodoLED® XL no longer functions properly for some unknown reason, proceed as follows:" }

{ "type": "ul", "children": [ "Unplug the power supply for half a minute and then plug back into the outlet (This action prompts a software reboot).", "Turn the lamp back on using the control unit and verify functionality." ], "text": "" }

Should the problem persist, please contact your sales representative or Biofrontera. The lamp may not be used until the problem has been rectified.

{ "type": "p", "children": [], "text": "Should the problem persist, please contact your sales representative or Biofrontera. The lamp may not be used until the problem has been rectified." }

For all other malfunctions and difficulties with operation please contact your sales representative or Biofrontera. You will find the contact details on page 2 of the manual.

{ "type": "p", "children": [], "text": "For all other malfunctions and difficulties with operation please contact your sales representative or Biofrontera. You will find the contact details on page 2 of the manual." }

Please have the system status (chapter 8.5.5) available if you contact your sales representative or Biofrontera.

{ "type": "p", "children": [], "text": "Please have the system status (chapter 8.5.5) available if you contact your sales representative or Biofrontera." }

10 Servicing and repairs

{ "type": "p", "children": [], "text": "\n\n10 Servicing and repairs\n" }

Servicing and repairs may only be performed by Biofrontera-authorized personnel. For RhodoLED® XL no spare parts for replacement by the user are available.

{ "type": "p", "children": [], "text": "Servicing and repairs may only be performed by Biofrontera-authorized personnel. For RhodoLED® XL no spare parts for replacement by the user are available." }

Device is not serviced while in use with patients.

{ "type": "p", "children": [], "text": "\nDevice is not serviced while in use with patients." }

If servicing or repairs are done by third parties, RhodoLED® XL warranty is void and Biofrontera cannot be held responsible for potential malfunctions of or damages to the device or the patients.

{ "type": "p", "children": [], "text": "\nIf servicing or repairs are done by third parties, RhodoLED® XL warranty is void and Biofrontera cannot be held responsible for potential malfunctions of or damages to the device or the patients." }

Figure 20: Servicing and maintenance may only be performed by Biofrontera

{ "type": "p", "children": [], "text": "\nFigure 20: Servicing and maintenance may only be performed by Biofrontera" }

11 Maintenance and Cleaning

{ "type": "p", "children": [], "text": "\n\n11 Maintenance and Cleaning\n" }

The device may under no circumstances be cleaned with aggressive cleaning agents or solvents (e.g. acetone or highly concentrated ethanol), as these promote wear and tear of the surface (paint coating) and labeling. Please use only a damp cloth when wiping over the labels.

{ "type": "p", "children": [], "text": "The device may under no circumstances be cleaned with aggressive cleaning agents or solvents (e.g. acetone or highly concentrated ethanol), as these promote wear and tear of the surface (paint coating) and labeling. Please use only a damp cloth when wiping over the labels." }

Please avoid allowing any penetration of liquids into the lamp, RhodoLED® XL is not waterproof and the electronics inside may be damaged. Do not maintain or clean the device while in use with patients.

{ "type": "p", "children": [], "text": "Please avoid allowing any penetration of liquids into the lamp, RhodoLED® XL is not waterproof and the electronics inside may be damaged. Do not maintain or clean the device while in use with patients." }

Always unplug the lamp prior to cleaning and please observe the following cleaning practices:

{ "type": "p", "children": [], "text": "Always unplug the lamp prior to cleaning and please observe the following cleaning practices:" }

<div class="scrollingtable"><table cellpadding="5" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td valign="top"><span class="Underline">Daily:</span></td><td valign="top">Wipe the plexiglass screen located on the bottom of the lamp head with a damp soft cloth (e. g. a microfiber cloth).</td> </tr> <tr> <td valign="top"><span class="Underline">Weekly:</span></td><td valign="top">Wipe the entire lamp. Do not use a very wet or dripping cleaning cloth. The unit is not waterproof and damage could occur. Weekly cleaning can be carried out using a damp cloth or Multi-Purpose Cleaners (Clorox Healthcare VersaSure Wipes).</td> </tr> <tr> <td colspan="2" valign="top"><span class="Underline">Please observe the following checks:</span></td> </tr> <tr class="Last"> <td valign="top"><span class="Underline">Monthly:</span></td><td valign="top">Check lamp for obvious visible damage such as damaged cables, worn off labeling, cracks on the lamp housing, etc.<p class="First">Do not use a damaged device for treatment and please inform your supplier.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"5\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td valign=\"top\"><span class=\"Underline\">Daily:</span></td><td valign=\"top\">Wipe the plexiglass screen located on the bottom of the lamp head with a damp soft cloth (e. g. a microfiber cloth).</td>\n</tr>\n<tr>\n<td valign=\"top\"><span class=\"Underline\">Weekly:</span></td><td valign=\"top\">Wipe the entire lamp. Do not use a very wet or dripping cleaning cloth. The unit is not waterproof and damage could occur. Weekly cleaning can be carried out using a damp cloth or Multi-Purpose Cleaners (Clorox Healthcare VersaSure Wipes).</td>\n</tr>\n<tr>\n<td colspan=\"2\" valign=\"top\"><span class=\"Underline\">Please observe the following checks:</span></td>\n</tr>\n<tr class=\"Last\">\n<td valign=\"top\"><span class=\"Underline\">Monthly:</span></td><td valign=\"top\">Check lamp for obvious visible damage such as damaged cables, worn off labeling, cracks on the lamp housing, etc.<p class=\"First\">Do not use a damaged device for treatment and please inform your supplier.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

12 Disposal Instructions

{ "type": "p", "children": [], "text": "\n12 Disposal Instructions\n" }

Follow all local and governmental disposal laws and regulations when disposing of the RhodoLED® XL.

{ "type": "p", "children": [], "text": "Follow all local and governmental disposal laws and regulations when disposing of the RhodoLED® XL." }

13 Technical Data

{ "type": "p", "children": [], "text": "\n\n13 Technical Data\n" }

13.1 Electrical Connectors

{ "type": "p", "children": [], "text": "\n13.1 Electrical Connectors\n" }

Power supply unit:

{ "type": "p", "children": [], "text": "\nPower supply unit:\n" }

{ "type": "ul", "children": [ "Primary wide-range input 100-120 VAC", "Secondary safety extra-low voltage output 48 VDC", "Secondary standby voltage output 5 VDC" ], "text": "" }

LED controller board:

{ "type": "p", "children": [], "text": "\nLED controller board:\n" }

{ "type": "ul", "children": [ "Supply voltage input 48 VDC", "2x CAN interface (2 pin)", "LED board FFC (12 pin)", "Distance sensor FFC (4 pin)", "2 x connector ventilator (3 pin)" ], "text": "" }

LED board:

{ "type": "p", "children": [], "text": "\nLED board:\n" }

{ "type": "ul", "children": [ "LED controller board FFC 12 pin (3 x LED circuits, temperature)", "Distance sensor FFC (4 pin)" ], "text": "" }

Human Machine Interface (HMI) for operation:

{ "type": "p", "children": [], "text": "\nHuman Machine Interface (HMI) for operation:\n" }

{ "type": "ul", "children": [ "Supply voltage input 48 VDC (2 pin)", "Secondary standby voltage input 5 VDC (4 pin)", "CAN interface (3 pin)", "USB interface (5 pin, covered)", "Speaker (2 pin)", "Touch controller (4 pin)", "Display data LVDS (40 pin)", "On/off switch (2 pin)", "HMI module to pillar external connector (10 pin)", "Grounding (1 pin)" ], "text": "" }

13.2 Specification

{ "type": "p", "children": [], "text": "\n13.2 Specification\n" }

<div class="scrollingtable"><table border="1" cellpadding="5" width="884px"> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Type</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">RhodoLED<span class="Sup">® </span> XL</p> <p>Medical device class III; Device of protection class 1</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Certification</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">UL certified E513735</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Software Version No.</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">g2.13.00.3840</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Service interval</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Biofrontera recommends performing service every 2 years</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Number of LEDs</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">225</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Typical peak wavelength</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">635 nm ± 5 nm</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Light dose</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Approx. 37 J/ cm<span class="Sup">2</span> at 4.9 inch (12.5 cm) distance, 13.5 min</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Typical irradiance</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">approx. 46 mW/cm² ± 20 % at 4.9 inch (12.5 cm) distance</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Max irradiance</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">approx. 55 mW/cm² at 4.9 inch (12.5 cm) distance</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Illuminated area</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">An area of 9.06 x 11.42 inch (23 cm x 29 cm) is illuminated using all panels in curved shape.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Max. deviation of the intensity over the treatment area</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Approx. 20 %</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Treatment distance</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.9 ± 0.6 inch (12.5 cm ± 1.5 cm)<br/>Measuring accuracy ± 0.3 cm (0.1 inch)</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Transport conditions</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Temperature: -4 °F to +140 °F (-20 °C to +60 °C)<br/>Atmospheric pressure: 500 hPa - 1060 hPa<br/>Relative humidity: 10 % - 90 %, non-condensing</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Storage conditions</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Temperature: +59 °F to +95 °F (+ 15 °C to +35 °C)<br/>Atmospheric pressure: 500 hPa - 1060 hPa<br/>Relative humidity: 10 % - 90 %, non-condensing<br/>Maximum storage time 180 days</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Operating conditions</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Temperature: +59 °F to +86 °F (+15 °C to + 30 °C)<br/>Atmospheric pressure: 500 hPa - 1060 hPa<br/>Operational altitude: ≤ 4800 m above NN<br/>Relative humidity: 10 % - 90 %, non-condensing.<br/>RhodoLED<span class="Sup">®</span> XL must be operated in environments of professional healthcare facilities.</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Operating voltage</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">100-120 VAC, 60 Hz</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Output voltage</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">48 VDC</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Power consumption</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">In normal operation: approx. 750 VA<br/>In standby mode: approx. 85 VA</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Over-voltage category</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">II</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Degree of contamination</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">2</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Material group (CTI)</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">IIIb</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Protection class</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">IP20</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Size of the lamp</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Height 5.76 ft (175.5 cm)<br/>Width: 2.51 ft (76.4 cm)<br/>Depth: 3.19 ft (97.1 cm)</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Total lamp weight</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="top">165 lb. (75 kg)</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"5\" width=\"884px\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Type</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">RhodoLED<span class=\"Sup\">® </span> XL</p>\n<p>Medical device class III; Device of protection class 1</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Certification</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">UL certified E513735</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Software Version No.</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">g2.13.00.3840</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Service interval</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Biofrontera recommends performing service every 2 years</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Number of LEDs</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">225</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Typical peak wavelength</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">635 nm ± 5 nm</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Light dose</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Approx. 37 J/ cm<span class=\"Sup\">2</span> at 4.9 inch (12.5 cm) distance, 13.5 min</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Typical irradiance</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">approx. 46 mW/cm² ± 20 % at 4.9 inch (12.5 cm) distance</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Max irradiance</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">approx. 55 mW/cm² at 4.9 inch (12.5 cm) distance</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Illuminated area</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">An area of 9.06 x 11.42 inch (23 cm x 29 cm) is illuminated using all panels in curved shape.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Max. deviation of the intensity over the treatment area</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Approx. 20 %</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Treatment distance</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">4.9 ± 0.6 inch (12.5 cm ± 1.5 cm)<br/>Measuring accuracy ± 0.3 cm (0.1 inch)</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Transport conditions</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Temperature: -4 °F to +140 °F (-20 °C to +60 °C)<br/>Atmospheric pressure: 500 hPa - 1060 hPa<br/>Relative humidity: 10 % - 90 %, non-condensing</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Storage conditions</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Temperature: +59 °F to +95 °F (+ 15 °C to +35 °C)<br/>Atmospheric pressure: 500 hPa - 1060 hPa<br/>Relative humidity: 10 % - 90 %, non-condensing<br/>Maximum storage time 180 days</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Operating conditions</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Temperature: +59 °F to +86 °F (+15 °C to + 30 °C)<br/>Atmospheric pressure: 500 hPa - 1060 hPa<br/>Operational altitude: ≤ 4800 m above NN<br/>Relative humidity: 10 % - 90 %, non-condensing.<br/>RhodoLED<span class=\"Sup\">®</span> XL must be operated in environments of professional healthcare facilities.</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Operating voltage</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">100-120 VAC, 60 Hz</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Output voltage</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">48 VDC</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Power consumption</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">In normal operation: approx. 750 VA<br/>In standby mode: approx. 85 VA</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Over-voltage category</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">II</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Degree of contamination</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">2</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Material group (CTI)</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">IIIb</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Protection class</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">IP20</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Size of the lamp</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Height 5.76 ft (175.5 cm)<br/>Width: 2.51 ft (76.4 cm)<br/>Depth: 3.19 ft (97.1 cm)</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Total lamp weight</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">165 lb. (75 kg)</td>\n</tr>\n</tbody>\n</table></div>" }

For further information please directly contact Biofrontera. 14 Labeling and Symbols

{ "type": "p", "children": [], "text": "For further information please directly contact Biofrontera.\n\n14 Labeling and Symbols\n" }

14.1 Label on the Lamp Base

{ "type": "p", "children": [], "text": "\n14.1 Label on the Lamp Base\n" }

Figure 21: Product label (serial number and date of manufacturing vary) with UDI code of RhodoLED® XL on lamp base, individual code depends on the serial number and date of manufacturing of the device.

{ "type": "p", "children": [], "text": "\nFigure 21: Product label (serial number and date of manufacturing vary) with UDI code of RhodoLED® XL on lamp base, individual code depends on the serial number and date of manufacturing of the device." }

Figure 22: No stepping on the device, no disposal in household waste, information on setup and service.

{ "type": "p", "children": [], "text": "\nFigure 22: No stepping on the device, no disposal in household waste, information on setup and service." }

Figure 23: Instruction for ground connector connection (not visible from the outside)

{ "type": "p", "children": [], "text": "\nFigure 23: Instruction for ground connector connection (not visible from the outside)" }

14.2 Label on LED Panels

{ "type": "p", "children": [], "text": "\n14.2 Label on LED Panels\n" }

Figure 24: Instruction and notes on the LED panels

{ "type": "p", "children": [], "text": "\nFigure 24: Instruction and notes on the LED panels" }

Figure 25: LED Panel numbering from Panel 1 to Panel 5

{ "type": "p", "children": [], "text": "\nFigure 25: LED Panel numbering from Panel 1 to Panel 5" }

14.3 Description of Symbols

{ "type": "p", "children": [], "text": "\n14.3 Description of Symbols\n" }

<div class="scrollingtable"><table border="1" cellpadding="10" width="100%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Symbol</span></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Description</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 06" src="/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Eye protection is required.</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 11" src="/dailymed/image.cfm?name=um-xl-symbol-11.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/><img alt="Symbol 10" src="/dailymed/image.cfm?name=um-xl-symbol-10.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Distance sensor of RhodoLED<span class="Sup">®</span> XL is a class 1 laser product. A class 1 laser product is safe under all conditions of normal use.</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle">IP20</td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">IP (Ingress Protection):<br/>Protection class of the housing against contact, foreign bodies and water<br/>2 = against ingress of solid foreign bodies ≥ 12,5 mm Ø and larger<br/>0 = <span class="Underline">Not</span> protected against water</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 19" src="/dailymed/image.cfm?name=um-xl-symbol-19.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Technical and electric devices must not be disposed of with household waste. Please pay attention to the applicable disposal instructions found in the user manual.</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 09" src="/dailymed/image.cfm?name=um-xl-symbol-09.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Symbol for existing ground connector connections</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 13" src="/dailymed/image.cfm?name=um-xl-symbol-13.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Follow the instructions for use!</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 08" src="/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Underline">General warning signs:</span> <br/> <ul> <li>Assembly and servicing may <span class="Underline">ONLY</span> be performed by Biofrontera</li> <li>Only transport lamp in the park position</li> <li>Caution: heavy, do NOT lift alone.</li> </ul> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 07" src="/dailymed/image.cfm?name=um-xl-symbol-07.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Warning sign - risk of trapping fingers!</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 02" src="/dailymed/image.cfm?name=um-xl-symbol-02.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Bright light, do not stare into the light source</td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><img alt="Symbol 18" src="/dailymed/image.cfm?name=um-xl-symbol-18.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></td><td align="left" class="Botrule Lrule Rrule Toprule" valign="middle">Do not step on the device.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"10\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><span class=\"Bold\">Symbol</span></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><span class=\"Bold\">Description</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 06\" src=\"/dailymed/image.cfm?name=um-xl-symbol-06.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Eye protection is required.</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 11\" src=\"/dailymed/image.cfm?name=um-xl-symbol-11.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/><img alt=\"Symbol 10\" src=\"/dailymed/image.cfm?name=um-xl-symbol-10.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Distance sensor of RhodoLED<span class=\"Sup\">®</span> XL is a class 1 laser product. A class 1 laser product is safe under all conditions of normal use.</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">IP20</td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">IP (Ingress Protection):<br/>Protection class of the housing against contact, foreign bodies and water<br/>2 = against ingress of solid foreign bodies ≥ 12,5 mm Ø and larger<br/>0 = <span class=\"Underline\">Not</span> protected against water</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 19\" src=\"/dailymed/image.cfm?name=um-xl-symbol-19.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Technical and electric devices must not be disposed of with household waste. Please pay attention to the applicable disposal instructions found in the user manual.</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 09\" src=\"/dailymed/image.cfm?name=um-xl-symbol-09.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Symbol for existing ground connector connections</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 13\" src=\"/dailymed/image.cfm?name=um-xl-symbol-13.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Follow the instructions for use!</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 08\" src=\"/dailymed/image.cfm?name=um-xl-symbol-08.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><span class=\"Underline\">General warning signs:</span>\n<br/>\n<ul>\n<li>Assembly and servicing may <span class=\"Underline\">ONLY</span> be performed by Biofrontera</li>\n<li>Only transport lamp in the park position</li>\n<li>Caution: heavy, do NOT lift alone.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 07\" src=\"/dailymed/image.cfm?name=um-xl-symbol-07.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Warning sign - risk of trapping fingers!</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 02\" src=\"/dailymed/image.cfm?name=um-xl-symbol-02.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Bright light, do not stare into the light source</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\"><img alt=\"Symbol 18\" src=\"/dailymed/image.cfm?name=um-xl-symbol-18.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></td><td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">Do not step on the device.</td>\n</tr>\n</tbody>\n</table></div>" }

15 Electromagnetic compatibility

{ "type": "p", "children": [], "text": "\n\n15 Electromagnetic compatibility\n" }

RhodoLED® XL complies with the EMC requirements of IEC 60601-1-2:2014 + A1:2020. Other electrical devices can influence the device.

{ "type": "p", "children": [], "text": "RhodoLED® XL complies with the EMC requirements of IEC 60601-1-2:2014 + A1:2020. Other electrical devices can influence the device." }

The use of accessories, transducers and cables other than those specified or provided by the manufacturer may result in increased electromagnetic emissions or reduced electromagnetic immunity of the equipment and may lead to incorrect operation. Assembly, service and repairs may only be performed by Biofrontera.

{ "type": "p", "children": [], "text": "The use of accessories, transducers and cables other than those specified or provided by the manufacturer may result in increased electromagnetic emissions or reduced electromagnetic immunity of the equipment and may lead to incorrect operation. Assembly, service and repairs may only be performed by Biofrontera." }

<div class="scrollingtable"><table border="1" cellpadding="10" width="100%"> <tbody class="Headless"> <tr class="First"> <td colspan="3">Guidelines and manufacturer's declaration - electromagnetic emissions</td> </tr> <tr> <td colspan="3"> <p class="First">RhodoLED<span class="Sup">®</span> XL is intended for operation in the electromagnetic environment detailed below.</p> <p>The customer or operator of the device should ensure that it is operated in this environment.</p> <p> <br/>The emission characteristics of RhodoLED<span class="Sup">®</span> XL allow its use in industrial and hospital and healthcare professional environments (CISPR 11, Class A). When used in a residential environment (for which CISPR 11 normally requires Class B), this device may not provide adequate protection of radio services. The user may need to take corrective action by moving or repositioning the device.</p> </td> </tr> <tr> <td><span class="Bold">Emission readings</span></td><td><span class="Bold">Conformity</span></td><td><span class="Bold">Electromagnetic environment - guidelines</span></td> </tr> <tr> <td>HF emissions CISPR 11</td><td>Group 1</td><td>RhodoLED<span class="Sup">®</span> XL only uses HF energy for its internal functionality. For this reason, its HF emission is very low and it is not likely that neighboring electronic devices would be disturbed.</td> </tr> <tr> <td>HF emissions in accordance with CISPR 11</td><td>Class A</td><td rowspan="3">RhodoLED<span class="Sup">®</span> XL is intended for operation in non-residential facilities and such like that are connected directly to a public low-voltage supply network that also supplies residential buildings.</td> </tr> <tr> <td>Harmonics in accordance with IEC 61000-3-2</td><td>Class A</td> </tr> <tr class="Last"> <td>Voltage fluctuations/flickers in accordance with IEC 61000-3-3</td><td>In compliance</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"10\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td colspan=\"3\">Guidelines and manufacturer's declaration - electromagnetic emissions</td>\n</tr>\n<tr>\n<td colspan=\"3\">\n<p class=\"First\">RhodoLED<span class=\"Sup\">®</span> XL is intended for operation in the electromagnetic environment detailed below.</p>\n<p>The customer or operator of the device should ensure that it is operated in this environment.</p>\n<p>\n<br/>The emission characteristics of RhodoLED<span class=\"Sup\">®</span> XL allow its use in industrial and hospital and healthcare professional environments (CISPR 11, Class A). When used in a residential environment (for which CISPR 11 normally requires Class B), this device may not provide adequate protection of radio services. The user may need to take corrective action by moving or repositioning the device.</p>\n</td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Emission readings</span></td><td><span class=\"Bold\">Conformity</span></td><td><span class=\"Bold\">Electromagnetic environment - guidelines</span></td>\n</tr>\n<tr>\n<td>HF emissions CISPR 11</td><td>Group 1</td><td>RhodoLED<span class=\"Sup\">®</span> XL only uses HF energy for its internal functionality. For this reason, its HF emission is very low and it is not likely that neighboring electronic devices would be disturbed.</td>\n</tr>\n<tr>\n<td>HF emissions in accordance with CISPR 11</td><td>Class A</td><td rowspan=\"3\">RhodoLED<span class=\"Sup\">®</span> XL is intended for operation in non-residential facilities and such like that are connected directly to a public low-voltage supply network that also supplies residential buildings.</td>\n</tr>\n<tr>\n<td>Harmonics in accordance with IEC 61000-3-2</td><td>Class A</td>\n</tr>\n<tr class=\"Last\">\n<td>Voltage fluctuations/flickers in accordance with IEC 61000-3-3</td><td>In compliance</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table border="1" cellpadding="10" width="100%"> <tbody class="Headless"> <tr class="First"> <td colspan="4">Guidelines and manufacturer's declaration - electromagnetic immunity</td> </tr> <tr> <td colspan="4">RhodoLED<span class="Sup">®</span> XL is intended for operation in the electromagnetic environment detailed below. The customer or operator of the device should ensure that it is operated in this environment.</td> </tr> <tr> <td><span class="Bold">Immunity tests</span></td><td><span class="Bold">IEC 60601 test levels</span></td><td><span class="Bold">Compliance level </span></td><td><span class="Bold">Electromagnetic environment - guidelines </span></td> </tr> <tr> <td>Static discharge in accordance with IEC 61000-4-2</td><td> <p class="First">±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge</p> </td><td>±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge</td><td>Floors should be made of wood or concrete or finished with ceramic tiles. If the floor is finished with synthetic material, the relative air humidity must be at least 30 %.</td> </tr> <tr> <td>Fast, transient electrical disturbances/bursts in accordance with IEC 61000-4-4</td><td>±2 kV for mains lines 100 kHz repetition frequency</td><td>±2 kV for mains lines</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.</td> </tr> <tr> <td>Surges in accordance with IEC 61000-4-5</td><td>±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth</td><td>±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.</td> </tr> <tr> <td>Voltage dips, brief interruptions and fluctuations in the supply voltage in accordance with IEC 61000-4-11</td><td>0 % U<span class="Sub">T</span> for 0.5 cycles at phase angles of 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° (applicable only to me equipment connected to single-phase a.c. mains)<br/>0 % U<span class="Sub">T</span> for 1 cycle<br/>70 % U<span class="Sub">T</span> for 25/30 cycles<br/>0 % U<span class="Sub">T</span> for 250/300 cycles</td><td>0 % U<span class="Sub">T</span> for 0.5 cycles at phase angles of 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° (applicable only to me equipment connected to single-phase a.c. mains)<br/>0 % U<span class="Sub">T</span> for 1 cycle<br/>70 % U<span class="Sub">T</span> for 25/30 cycles<br/>0 % U<span class="Sub">T</span> for 250/300 cycles</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.<br/>If the operator of the device needs functionality to be maintained despite interruptions in the energy supply, it is advisable to run the device on an uninterruptable power supply or a battery.</td> </tr> <tr> <td>Power frequency (50/60 Hz) magnetic field in accordance with IEC 61000-4-8</td><td>30 A/m</td><td>30 A/m</td><td>Mains frequency magnetic fields should correspond to the values typically found in the commercial and hospital environment.</td> </tr> <tr class="Last"> <td colspan="4">Comment: U<span class="Sub">T</span> is the mains AC voltage prior to application of the test level</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"10\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td colspan=\"4\">Guidelines and manufacturer's declaration - electromagnetic immunity</td>\n</tr>\n<tr>\n<td colspan=\"4\">RhodoLED<span class=\"Sup\">®</span> XL is intended for operation in the electromagnetic environment detailed below. The customer or operator of the device should ensure that it is operated in this environment.</td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Immunity tests</span></td><td><span class=\"Bold\">IEC 60601 test levels</span></td><td><span class=\"Bold\">Compliance level </span></td><td><span class=\"Bold\">Electromagnetic environment - guidelines </span></td>\n</tr>\n<tr>\n<td>Static discharge in accordance with IEC 61000-4-2</td><td>\n<p class=\"First\">±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge</p>\n</td><td>±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge</td><td>Floors should be made of wood or concrete or finished with ceramic tiles. If the floor is finished with synthetic material, the relative air humidity must be at least 30 %.</td>\n</tr>\n<tr>\n<td>Fast, transient electrical disturbances/bursts in accordance with IEC 61000-4-4</td><td>±2 kV for mains lines 100 kHz repetition frequency</td><td>±2 kV for mains lines</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.</td>\n</tr>\n<tr>\n<td>Surges in accordance with IEC 61000-4-5</td><td>±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth</td><td>±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.</td>\n</tr>\n<tr>\n<td>Voltage dips, brief interruptions and fluctuations in the supply voltage in accordance with IEC 61000-4-11</td><td>0 % U<span class=\"Sub\">T</span> for 0.5 cycles at phase angles of 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° (applicable only to me equipment connected to single-phase a.c. mains)<br/>0 % U<span class=\"Sub\">T</span> for 1 cycle<br/>70 % U<span class=\"Sub\">T</span> for 25/30 cycles<br/>0 % U<span class=\"Sub\">T</span> for 250/300 cycles</td><td>0 % U<span class=\"Sub\">T</span> for 0.5 cycles at phase angles of 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° (applicable only to me equipment connected to single-phase a.c. mains)<br/>0 % U<span class=\"Sub\">T</span> for 1 cycle<br/>70 % U<span class=\"Sub\">T</span> for 25/30 cycles<br/>0 % U<span class=\"Sub\">T</span> for 250/300 cycles</td><td>The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.<br/>If the operator of the device needs functionality to be maintained despite interruptions in the energy supply, it is advisable to run the device on an uninterruptable power supply or a battery.</td>\n</tr>\n<tr>\n<td>Power frequency (50/60 Hz) magnetic field in accordance with IEC 61000-4-8</td><td>30 A/m</td><td>30 A/m</td><td>Mains frequency magnetic fields should correspond to the values typically found in the commercial and hospital environment.</td>\n</tr>\n<tr class=\"Last\">\n<td colspan=\"4\">Comment: U<span class=\"Sub\">T</span> is the mains AC voltage prior to application of the test level</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table border="1" cellpadding="10" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td colspan="4">Guidelines and manufacturer's declaration - electromagnetic immunity</td> </tr> <tr> <td colspan="4">RhodoLED<span class="Sup">®</span> XL is intended for operation in the electromagnetic environment detailed below. The customer or operator of the device should ensure that it is operated in this environment.</td> </tr> <tr> <td align="left"><span class="Bold">Immunity tests</span></td><td align="left"><span class="Bold">IEC 60601 test levels</span></td><td align="left"><span class="Bold">Compliance level </span></td><td align="left"><span class="Bold">Electromagnetic environment - guidelines </span></td> </tr> <tr> <td align="left" valign="top"> <p class="First">Conducted HF disturbances</p> <p>in accordance</p> <p>with IEC 61000-4-6</p> <p></p> </td><td align="left" valign="top"> <p class="First">3 V</p> <p>150 kHz to 80 MHz</p> <p></p> <p>6 V<br/>ISM bands 0.15 - 80 MHz<br/>80 % AM with 1 kHz</p> <p></p> </td><td align="left" valign="top"> <p class="First">3 V</p> <p></p> <p></p> <p></p> <p>6 V</p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> </td><td valign="top"> <p class="First">Portable and mobile communication devices should not be used in closer proximity of the unit or its cables than the recommended safety distance of 300 mm.</p> <p></p> <p></p> </td> </tr> <tr> <td align="left" valign="top"> <p class="First">Radiated HF disturbances</p> <p>in accordance</p> <p>with IEC 61000-4-3</p> </td><td align="left" valign="top">3 V/m 80 MHz to 2.7 GHz<br/>80 % AM with 1 kHz</td><td align="left" valign="top">3 V/m</td><td valign="top"> <p class="First">Interference may occur in the vicinity of equipment marked with the following symbol.</p> <p> <img alt="Symbol 05" src="/dailymed/image.cfm?name=um-xl-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd"/></p> </td> </tr> <tr class="Last"> <td colspan="4">Comment 1: These guidelines may not be applicable in all cases. The propagation of electromagnetic values is influenced by absorptions and reflections of buildings, objects, and people.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"10\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td colspan=\"4\">Guidelines and manufacturer's declaration - electromagnetic immunity</td>\n</tr>\n<tr>\n<td colspan=\"4\">RhodoLED<span class=\"Sup\">®</span> XL is intended for operation in the electromagnetic environment detailed below. The customer or operator of the device should ensure that it is operated in this environment.</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Immunity tests</span></td><td align=\"left\"><span class=\"Bold\">IEC 60601 test levels</span></td><td align=\"left\"><span class=\"Bold\">Compliance level </span></td><td align=\"left\"><span class=\"Bold\">Electromagnetic environment - guidelines </span></td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\">\n<p class=\"First\">Conducted HF disturbances</p>\n<p>in accordance</p>\n<p>with IEC 61000-4-6</p>\n<p></p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">3 V</p>\n<p>150 kHz to 80 MHz</p>\n<p></p>\n<p>6 V<br/>ISM bands 0.15 - 80 MHz<br/>80 % AM with 1 kHz</p>\n<p></p>\n</td><td align=\"left\" valign=\"top\">\n<p class=\"First\">3 V</p>\n<p></p>\n<p></p>\n<p></p>\n<p>6 V</p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n<p></p>\n</td><td valign=\"top\">\n<p class=\"First\">Portable and mobile communication devices should not be used in closer proximity of the unit or its cables than the recommended safety distance of 300 mm.</p>\n<p></p>\n<p></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\">\n<p class=\"First\">Radiated HF disturbances</p>\n<p>in accordance</p>\n<p>with IEC 61000-4-3</p>\n</td><td align=\"left\" valign=\"top\">3 V/m 80 MHz to 2.7 GHz<br/>80 % AM with 1 kHz</td><td align=\"left\" valign=\"top\">3 V/m</td><td valign=\"top\">\n<p class=\"First\">Interference may occur in the vicinity of equipment marked with the following symbol.</p>\n<p>\n<img alt=\"Symbol 05\" src=\"/dailymed/image.cfm?name=um-xl-symbol-05.jpg&amp;setid=650daa9f-aeec-49ce-95b9-5fa20b988afd\"/></p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td colspan=\"4\">Comment 1: These guidelines may not be applicable in all cases. The propagation of electromagnetic values is influenced by absorptions and reflections of buildings, objects, and people.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table border="1" cellpadding="10" width="100%"> <tbody class="Headless"> <tr class="First"> <td>Recommended safety distances between portable and mobile HF telecommunication devices and the RhodoLED<span class="Sup">®</span> XL.</td> </tr> <tr class="Last"> <td>Portable RF communications equipment (radios, including their accessories such as antenna cables and external antennas) should not be used at a distance less than 30 cm (or 12 inch) from the manufacturer's specified parts and leads of the RhodoLED<span class="Sup">®</span> XL. Failure to do so may result in a reduction in the performance of the device.<br/>RhodoLED<span class="Sup">®</span> XL should not be used directly alongside or between other electrical equipment.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"10\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td>Recommended safety distances between portable and mobile HF telecommunication devices and the RhodoLED<span class=\"Sup\">®</span> XL.</td>\n</tr>\n<tr class=\"Last\">\n<td>Portable RF communications equipment (radios, including their accessories such as antenna cables and external antennas) should not be used at a distance less than 30 cm (or 12 inch) from the manufacturer's specified parts and leads of the RhodoLED<span class=\"Sup\">®</span> XL. Failure to do so may result in a reduction in the performance of the device.<br/>RhodoLED<span class=\"Sup\">®</span> XL should not be used directly alongside or between other electrical equipment.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table border="1" cellpadding="10" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td colspan="3">Guidelines and manufacturer’s declaration – proximity fields from RF wireless communication equipment</td> </tr> <tr> <td colspan="3">RhodoLED<span class="Sup">®</span> XL is intended for operation in the electromagnetic environment detailed below. The customer or operator of the device should ensure that it is operated in this environment.</td> </tr> <tr> <td><span class="Bold">Service</span></td><td><span class="Bold">Frequency range/ discrete frequencies MHz </span></td><td><span class="Bold">Compliance level</span> <br/> <span class="Bold">[V/m] </span></td> </tr> <tr> <td>TETRA 400</td><td>385</td><td>27</td> </tr> <tr> <td>GMRS 460, FRS 460</td><td>450</td><td>29</td> </tr> <tr> <td>LTE Band 13, 17</td><td>710<br/>745<br/>780</td><td>9</td> </tr> <tr> <td>GSM 800/900, TETRA 800,<br/>iDEN 820, CDMA,<br/>LTE Band 5</td><td>810<br/>870<br/>930</td><td>28</td> </tr> <tr> <td>GSM 1800, CDMA 1900,<br/>GSM 1900,DECT,<br/>LTE Band 1,3,4, 25</td><td>1720<br/>1845<br/>1970</td><td>28</td> </tr> <tr> <td>Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7</td><td>2450</td><td>28</td> </tr> <tr class="Last"> <td>WLAN 802.11<br/>a/n</td><td>5240<br/>5500<br/>5785</td><td>9</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"10\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td colspan=\"3\">Guidelines and manufacturer’s declaration – proximity fields from RF wireless communication equipment</td>\n</tr>\n<tr>\n<td colspan=\"3\">RhodoLED<span class=\"Sup\">®</span> XL is intended for operation in the electromagnetic environment detailed below. The customer or operator of the device should ensure that it is operated in this environment.</td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Service</span></td><td><span class=\"Bold\">Frequency range/ discrete frequencies MHz </span></td><td><span class=\"Bold\">Compliance level</span>\n<br/>\n<span class=\"Bold\">[V/m] </span></td>\n</tr>\n<tr>\n<td>TETRA 400</td><td>385</td><td>27</td>\n</tr>\n<tr>\n<td>GMRS 460, FRS 460</td><td>450</td><td>29</td>\n</tr>\n<tr>\n<td>LTE Band 13, 17</td><td>710<br/>745<br/>780</td><td>9</td>\n</tr>\n<tr>\n<td>GSM 800/900, TETRA 800,<br/>iDEN 820, CDMA,<br/>LTE Band 5</td><td>810<br/>870<br/>930</td><td>28</td>\n</tr>\n<tr>\n<td>GSM 1800, CDMA 1900,<br/>GSM 1900,DECT,<br/>LTE Band 1,3,4, 25</td><td>1720<br/>1845<br/>1970</td><td>28</td>\n</tr>\n<tr>\n<td>Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7</td><td>2450</td><td>28</td>\n</tr>\n<tr class=\"Last\">\n<td>WLAN 802.11<br/>a/n</td><td>5240<br/>5500<br/>5785</td><td>9</td>\n</tr>\n</tbody>\n</table></div>" }

Version 1.9 SW_G2

{ "type": "p", "children": [], "text": "\nVersion 1.9 SW_G2\n" }

Outer Packaging, single Carton

{ "type": "p", "children": [], "text": "\nOuter Packaging, single Carton\n" }

NDC 70621-101-10

{ "type": "p", "children": [], "text": "NDC 70621-101-10" }

Ameluz® Rx Only

{ "type": "p", "children": [], "text": "Ameluz® Rx Only" }

(aminolevulinic acid HCl) topical gel, 10%

{ "type": "p", "children": [], "text": "(aminolevulinic acid HCl) topical gel, 10%" }

Use contents within 3 months after opening. Discard after: __/ __/ __.

{ "type": "p", "children": [], "text": "Use contents within 3 months after opening. Discard after: __/ __/ __." }

Store refrigerated 2°-8°C (36°-46°F), excursions permitted to 15°-30°C (59°-86°F).

{ "type": "p", "children": [], "text": "Store refrigerated 2°-8°C (36°-46°F), excursions permitted to 15°-30°C (59°-86°F)." }

Keep out of the sight and reach of children.

{ "type": "p", "children": [], "text": "Keep out of the sight and reach of children." }

See package insert for dosage information. Net Wt. 2 g

{ "type": "p", "children": [], "text": "See package insert for dosage information. Net Wt. 2 g" }

Distributed By: Biofrontera Inc.

{ "type": "p", "children": [], "text": "Distributed By: Biofrontera Inc." }

120 Presidential Way, Suite 330

{ "type": "p", "children": [], "text": "120 Presidential Way, Suite 330" }

Woburn, MA 01801

{ "type": "p", "children": [], "text": "Woburn, MA 01801" }

Product of Switzerland

{ "type": "p", "children": [], "text": "Product of Switzerland" }

For Topical Use Only with BF-RhodoLED® or RhodoLED® XL lamp

{ "type": "p", "children": [], "text": "For Topical Use Only with BF-RhodoLED® or RhodoLED® XL lamp" }

Healthcare Professionals Only

{ "type": "p", "children": [], "text": "Healthcare Professionals Only" }

Ingredients: Each gram of Ameluz Gel contains 100 mg of the active ingredient, aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid) and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglyceride, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water

{ "type": "p", "children": [], "text": "Ingredients: Each gram of Ameluz Gel contains 100 mg of the active ingredient, aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid) and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglyceride, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water" }

Outer Packaging, Physician's Sample

{ "type": "p", "children": [], "text": "\nOuter Packaging, Physician's Sample\n" }

NDC 70621-101-30

{ "type": "p", "children": [], "text": "NDC 70621-101-30" }

Ameluz® Rx Only

{ "type": "p", "children": [], "text": "Ameluz® Rx Only" }

Physician's Sample

{ "type": "p", "children": [], "text": "Physician's Sample" }

Not for sale

{ "type": "p", "children": [], "text": "Not for sale" }

(aminolevulinic acid HCl) topical gel, 10%

{ "type": "p", "children": [], "text": "(aminolevulinic acid HCl) topical gel, 10%" }

Use contents within 3 months after opening. Discard after: __/ __/ __.

{ "type": "p", "children": [], "text": "Use contents within 3 months after opening. Discard after: __/ __/ __." }

Store refrigerated 2°-8°C (36°-46°F), excursions permitted to 15°-30°C (59°-86°F).

{ "type": "p", "children": [], "text": "Store refrigerated 2°-8°C (36°-46°F), excursions permitted to 15°-30°C (59°-86°F)." }

Keep out of the sight and reach of children.

{ "type": "p", "children": [], "text": "Keep out of the sight and reach of children." }

See package insert for dosage information. Net Wt. 2 g

{ "type": "p", "children": [], "text": "See package insert for dosage information. Net Wt. 2 g" }

Distributed By: Biofrontera Inc.

{ "type": "p", "children": [], "text": "Distributed By: Biofrontera Inc." }

120 Presidential Way, Suite 330

{ "type": "p", "children": [], "text": "120 Presidential Way, Suite 330" }

Woburn, MA 01801

{ "type": "p", "children": [], "text": "Woburn, MA 01801" }

Product of Switzerland

{ "type": "p", "children": [], "text": "Product of Switzerland" }

For Topical Use Only with BF-RhodoLED® lamp or RhodoLED® XL lamp

{ "type": "p", "children": [], "text": "For Topical Use Only with BF-RhodoLED® lamp or RhodoLED® XL lamp" }

Healthcare Professionals Only

{ "type": "p", "children": [], "text": "Healthcare Professionals Only" }

Ingredients: Each gram of Ameluz Gel contains 100 mg of the active ingredient, aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid) and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglyceride, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water

{ "type": "p", "children": [], "text": "Ingredients: Each gram of Ameluz Gel contains 100 mg of the active ingredient, aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid) and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglyceride, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water" }

Outer Packaging, Multipack

{ "type": "p", "children": [], "text": "\n\nOuter Packaging, Multipack\n" }

10 tubes with Net Wt. 2g each NDC 70621-101-20

{ "type": "p", "children": [], "text": "10 tubes with Net Wt. 2g each NDC 70621-101-20" }

Ameluz® Rx Only

{ "type": "p", "children": [], "text": "Ameluz® Rx Only" }

(aminolevulinic acid HCl) topical gel, 10%

{ "type": "p", "children": [], "text": "(aminolevulinic acid HCl) topical gel, 10%" }

For Topical Use Only with BF-RhodoLED® lamp or RhodoLED® XL lamp

{ "type": "p", "children": [], "text": "For Topical Use Only with BF-RhodoLED® lamp or RhodoLED® XL lamp" }

Healthcare Professionals Only

{ "type": "p", "children": [], "text": "Healthcare Professionals Only" }

See package insert for dosage information.

{ "type": "p", "children": [], "text": "See package insert for dosage information." }

Distributed By: Biofrontera Inc.

{ "type": "p", "children": [], "text": "Distributed By: Biofrontera Inc." }

120 Presidential Way, Suite 330

{ "type": "p", "children": [], "text": "120 Presidential Way, Suite 330" }

Woburn, MA 01801

{ "type": "p", "children": [], "text": "Woburn, MA 01801" }

Product of Switzerland

{ "type": "p", "children": [], "text": "Product of Switzerland" }

10 tubes with Net Wt. 2g each NDC 70621-101-20

{ "type": "p", "children": [], "text": "10 tubes with Net Wt. 2g each NDC 70621-101-20" }

Ameluz® Rx Only

{ "type": "p", "children": [], "text": "Ameluz® Rx Only" }

(aminolevulinic acid HCl) topical gel, 10%

{ "type": "p", "children": [], "text": "(aminolevulinic acid HCl) topical gel, 10%" }

Use contents within 3 months after opening the individual tube.

{ "type": "p", "children": [], "text": "Use contents within 3 months after opening the individual tube." }

Place the enclosed Discard after: __/ __/ __.tag on tube once opened.

{ "type": "p", "children": [], "text": "Place the enclosed Discard after: __/ __/ __.tag on tube once opened." }

Store refrigerated 2°-8°C (36°-46°F), excursions permitted to 15°-30°C (59°-86°F).

{ "type": "p", "children": [], "text": "Store refrigerated 2°-8°C (36°-46°F), excursions permitted to 15°-30°C (59°-86°F)." }

Keep out of the sight and reach of children.

{ "type": "p", "children": [], "text": "Keep out of the sight and reach of children." }

See package insert for dosage information.

{ "type": "p", "children": [], "text": "See package insert for dosage information." }

Ingredients:Each gram of Ameluz Gel contains 100 mg of the active ingredient, aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid) and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglyceride, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water

{ "type": "p", "children": [], "text": "Ingredients:Each gram of Ameluz Gel contains 100 mg of the active ingredient, aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid) and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglyceride, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water" }

Distributed By: Biofrontera Inc.

{ "type": "p", "children": [], "text": "Distributed By: Biofrontera Inc." }

120 Presidential Way, Suite 330

{ "type": "p", "children": [], "text": "120 Presidential Way, Suite 330" }

Woburn, MA 01801

{ "type": "p", "children": [], "text": "Woburn, MA 01801" }

Product of Switzerland

{ "type": "p", "children": [], "text": "Product of Switzerland" }

The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.

{ "type": "p", "children": [], "text": "\nThe LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.\n" }

After mixing, the LEVULAN KERASTICK topical solution 20% is intended for direct application to individual lesions diagnosed as actinic keratoses and not to perilesional skin. This product is not intended for application by patients or unqualified medical personnel.  Application should involve lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.

The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment session. Each individual LEVULAN KERASTICK applicator should be used for only one patient.

LEVULAN KERASTICK photodynamic therapy for actinic keratoses is a two-stage process involving application of the LEVULAN KERASTICK topical solution to the target lesions and then illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours for upper extremity lesions or after 14-18 hours for face or scalp lesions.

<div class="scrollingtable"><table width="100%"> <caption> <span>TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy</span> </caption> <col width="34%"/> <col width="33%"/> <col width="33%"/> <tfoot> <tr class="First Last"> <td align="left" class="Botrule" colspan="3" valign="top"><span class="Sup">1</span>The incubation time is 14-18 hours for actinic keratosis lesions on the face or scalp. <br/> <span class="Sup">2 </span>The incubation time is 3 hours for actinic keratosis lesions on the upper extremities. </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">LEVULAN KERASTICK topical solution application</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Time window <span class="Sup">1</span>for Blue Light Illumination for face or scalp </span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Time window <span class="Sup">2</span>for Blue Light Illumination for upper extremities </span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">6 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">8 pm to Midnight</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">9 am</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">7 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">9 pm to 1 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">10 am</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">8 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">10 pm to 2 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">11 am</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">9 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">11 pm to 3 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">12 Noon</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">10 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Midnight to 4 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">11 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1 am to 5 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">2 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">12 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">2 am to 6 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">3 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">3 am to 7 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">4 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">2 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">4 am to 8 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">5 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">3 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">5 am to 9 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">6 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">4 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">6 am to 10 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">7 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">5 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">7 am to 11 am</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">8 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">6 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">8 am to Noon</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">9 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">7 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">9 am to 1 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">10 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">8 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">10 am to 2 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">11 pm</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">9 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">11 am to 3 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">12 Midnight</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">10 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Noon to 4 pm</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1 am</p> </td> </tr> </tbody> </table></div>

If for any reason the patient cannot be given BLU-U Blue Light Photodynamic Therapy Illuminator treatment during the prescribed time after applying LEVULAN KERASTICK topical solution, he or she may nonetheless experience sensations of stinging and/or burning if the photosensitized actinic keratoses are exposed to sunlight or prolonged or intense light at that time. Advise the patient to wear appropriate protective apparel (e.g., wide-brimmed hat, long sleeve shirt, gloves) to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK topical solution. Advise the patient to reduce light exposure if the sensations of stinging and/or burning are experienced.

LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved 8 weeks after the initial treatment.

Step A - Treatment of Actinic Keratoses with LEVULAN KERASTICK Topical Solution

Preparation of Lesions

Actinic keratoses targeted for treatment should be clean and dry prior to application of LEVULAN KERASTICK Topical Solution.

Preparation of LEVULAN KERASTICK topical solution

The LEVULAN KERASTICK applicator consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains aminolevulinic acid HCl as a dry solid. LEVULAN KERASTICK topical solution is prepared by crushing the glass ampoules and mixing the contents together.

The LEVULAN KERASTICK topical solution can be prepared either manually, or using the optional KERASTICK KRUSHER™.  These methods are illustrated below.

Figure 1:   Manual Preparation:

Figure 2:  Optional KERASTICK KRUSHER Preparation:

The LEVULAN KERASTICK topical solution must be used within two (2) hours of activation. If the solution is not completely applied within 2 hours of the activation, discard the applicator. If needed, use a new LEVULAN KERASTICK applicator.

Application of LEVULAN KERASTICK topical solution

Application of LEVULAN KERASTICK topical solution to Face or Scalp Lesions:

Following solution admixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution.  Apply the solution directly to the target lesions by dabbing gently with the wet applicator tip. Enough solution should be applied to uniformly wet the lesion surface, including the edges without excess running or dripping. Once the initial application has dried, apply again in the same manner.

Do not apply the LEVULAN KERASTICK topical solution to the periorbital area or allow it to contact ocular or mucosal surfaces.

Photosensitization of the treated lesions will take place over the next 14-18 hours. The actinic keratoses should not be washed during this time. The patient should be advised to wear a wide-brimmed hat or other protective apparel to shade the treated actinic keratoses from sunlight or other bright light sources until BLU-U Blue Light Photodynamic Therapy Illuminator treatment. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

At the visit for light illumination before treatment, the actinic keratoses treated with the LEVULAN KERASTICK topical solution should be gently rinsed with water and patted dry.

For Lesions on the Upper Extremities

Following solution mixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution.  Apply the solution directly to the target lesions by dabbing gently with the wet applicator tip. Enough solution should be applied to uniformly wet the lesion surface, including the edges without excess running or dripping.

Occlude the upper extremity with low density polyethylene plastic wrap and hold in place with an elastic net dressing. Figure 3: Method of Occlusion for Upper Extremities

The patient should wear a long-sleeved shirt and/or gloves or other protective apparel to shade the treated actinic keratoses from sunlight or other bright light sources until BLU-U Blue Light Photodynamic Therapy Illuminator treatment. Photosensitization of the treated lesions will take place over the next 3 hours. The actinic keratoses should not be washed during this time. Remove the occlusive dressing prior to light treatment and gently rinse the treated area(s) with water and pat dry before light illumination.

Step B - Administration of BLU-U Treatment:

LEVULAN KERASTICK is not intended for use with any device other than the BLU-U Blue Light Photodynamic Therapy Illuminator. Use of LEVULAN KERASTICK without subsequent BLU-U Blue Light Photodynamic Therapy Illuminator illumination is not recommended.

Photoactivation of actinic keratoses treated with LEVULAN KERASTICK topical solution is accomplished with illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator. A 1000 second (16 minutes 40 seconds) exposure is required to provide a 10 J/cm 2light dose. During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions. Please refer to the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions for further information on conducting the light treatment. Patients should be advised that transient stinging and/or burning at the target lesion sites occurs during the period of light exposure.

If blue light treatment with the BLU-U Blue Light Photodynamic Therapy Illuminator is interrupted or stopped for any reason, it should not be restarted and the patient should be advised to protect the treated lesions from exposure to sunlight or prolonged or intense light for at least 40 hours after applying the LEVULAN KERASTICK topical solution.

For patients with facial lesions:

For patients with scalp lesions:

For patients with upper extremity lesions:

For topical solution: 354 mg of aminolevulinic acid hydrochloride as a powder in a plastic applicator device.  Upon mixture, LEVULAN KERASTICK is a topical solution containing 20% aminolevulinic acid hydrochloride (ALA HCl) by weight.

{ "type": "p", "children": [], "text": "For topical solution: 354 mg of aminolevulinic acid hydrochloride as a powder in a plastic applicator device.  Upon mixture, LEVULAN KERASTICK is a topical solution containing 20% aminolevulinic acid hydrochloride (ALA HCl) by weight." }

The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with:

{ "type": "p", "children": [], "text": "The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with:" }

{ "type": "ul", "children": [ "Cutaneous photosensitivity at wavelengths of 400-450 nm\n \n [see\n \n Warnings and Precautions (5.2)]\n \n \n", "Porphyria or known allergies to porphyrins\n \n [see\n \n Warnings and Precautions (5.2)]\n \n \n", "Known sensitivity to any of the components of the LEVULAN KERASTICK." ], "text": "" }

Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions.

Therefore, before exposure to sunlight, patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin.

Application of LEVULAN KERASTICK topical solution to perilesional areas of photodamaged skin of the face, scalp or upper extremities may result in photosensitization. Upon exposure to activating light from the BLU-U, such photosensitized skin may produce a stinging and/or burning sensation and may become erythematous and/or edematous in a manner similar to that of actinic keratoses treated with LEVULAN KERASTICK Photodynamic Therapy.  Because of the potential for skin to become photosensitized, the LEVULAN KERASTICK topical solution should be used by a qualified health professional to apply drug to no more than 5mm of perilesional skin surrounding the target actinic keratosis lesions.

If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, the patient should call the doctor. The patient should also continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced.

The LEVULAN KERASTICK topical solution contains alcohol and is intended for topical use only. Irritation may be experienced if this product is applied to eyes or mucous membranes.  Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

The LEVULAN KERASTICK for topical solution has not been tested on patients with inherited or acquired coagulation defects.

Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, no non-cutaneous adverse events were found to be consistently associated with LEVULAN KERASTICK photodynamic therapy.

Photodynamic Therapy Response:The constellation of transient local symptoms of stinging and/or burning, itching, erythema and edema as a result of LEVULAN KERASTICK photodynamic therapy (PDT) was observed in all clinical trials for actinic keratoses treatment. Stinging and/or burning subsided between 1 minute and 24 hours after the BLU-U Blue Light Photodynamic Therapy Illuminator was turned off, and appeared qualitatively similar to that perceived by patients with erythropoietic protoporphyria upon exposure to sunlight. There was no clear drug dose or light dose dependent change in the incidence or severity of stinging and/or burning.

Local skin reactions at the application site were observed in 99% of subjects treated with LEVULAN KERASTICK topical solution and BLU-U Blue Light Photodynamic Therapy Illuminator. The most common local adverse reactions (incidence ≥ 10%) were application site stinging/burning, erythema, edema, scaling/crusting, hypo/hyperpigmentation, itching, erosion, oozing/vesiculation/crusting, dryness.

In the trials for face and scalp lesions, severe stinging and/or burning at one or more lesions during light treatment was reported by at least 50% of subjects.  Severe stinging and/or burning also occurred during light treatment in 9% of subjects receiving treatment for upper extremity lesions. The majority of subjects reported that all lesions treated exhibited at least slight stinging and/or burning.  In trials of the face and scalp, the sensation of stinging/burning appeared to reach a plateau at 6 minutes into the treatment. Less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light treatment in the trial for upper extremity lesions.

In trials for the face or scalp lesions, 99% of the active treatment group and 79% of the vehicle group experienced erythema shortly after treatment. In the trial for the upper extremity lesions, 99% of LEVULAN KERASTICK topical solution treatment group and 52% of the vehicle group experienced erythema on visit Days 2-3. Approximately 35% of LEVULAN KERASTICK topical solution group had edema, while edema occurred in <1% of the vehicle group. Both erythema and edema resolved to baseline or improved by 4 weeks after therapy for face or scalp. Edema resolved by 4 weeks and erythema resolved to baseline by 8 weeks for upper extremities.

The application of LEVULAN KERASTICK topical solution to perilesional skin resulted in stinging, burning, erythema and edema similar to treated actinic keratoses [see Warnings and Precautions (5.2)] .

Other Localized Cutaneous Adverse Experiences:Table 2depicts the incidence and severity of cutaneous adverse events in trials for the face and scalp.

<div class="scrollingtable"><table width="100%"> <caption> <span>TABLE 2 Post-PDT Cutaneous Adverse Events – ALA-018/ALA-019 For the Face and Scalp</span> </caption> <col width="23%"/> <col width="11%"/> <col width="8%"/> <col width="11%"/> <col width="8%"/> <col width="11%"/> <col width="8%"/> <col width="11%"/> <col width="8%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="4" valign="top"> <p class="First"> <span class="Bold">FACE</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="4" valign="top"> <p class="First"> <span class="Bold">SCALP</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">LEVULAN KERASTICK Topical Solution + PDT (n=139)</span> </p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Vehicle + PDT  (n=41)</span> </p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">LEVULAN KERASTICK Topical Solution + PDT</span> <br/> <span class="Bold">(n=42)</span> </p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">Vehicle + PDT (n=21)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Degree of Severity</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Mild/ Moderate</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Severe</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Mild/ Moderate</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Severe</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Mild/ Moderate</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Severe</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Mild/ Moderate</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Severe</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Scaling/Crusting</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">71%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">12%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">64%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">19%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Pain</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Tenderness</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Itching</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">25%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">14%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">19%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Edema</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Ulceration</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Bleeding/Hemorrhage</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Hypo/hyper-pigmentation</p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First">22%</p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First">20%</p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First">36%</p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First">33%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Vesiculation</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Pustules</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Oozing</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Dysesthesia</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Scabbing</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Erosion</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">14%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Excoriation</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Wheal/Flare</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Skin disorder NOS</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">12%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td> </tr> </tbody> </table></div>

Table 3depicts the incidence of other cutaneous adverse events in Phase 3 studies for the upper extremities.

<div class="scrollingtable"><table width="100%"> <caption> <span>TABLE 3 Percentage of Subjects with Cutaneous Adverse Reactions by the Most Severe Grade Reported Post-Baseline – CP0108 For Upper Extremities</span> </caption> <col width="22%"/> <col width="14%"/> <col width="15%"/> <col width="11%"/> <col width="14%"/> <col width="15%"/> <col width="9%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="middle"> <p class="First"> <span class="Bold">LEVULAN KERASTICK</span> <br/> <span class="Bold">Topical Solution + PDT </span> <br/> <span class="Bold">(N=135)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="middle"> <p class="First"> <span class="Bold">Vehicle + PDT</span> <br/> <br/> <span class="Bold">(N=134)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Degree of Severity</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Minimal/ <br/> Mild </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Moderate/ <br/> Severe </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Total</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Minimal/ <br/> Mild </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Moderate/ <br/> Severe </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Total</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Edema</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">51%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">56%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">8%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Erythema</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">35%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">65%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">100%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">63%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">12%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">75%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Hyper-pigmentation</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">64%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">9%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">73%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">57%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">10%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">66%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Hypo-pigmentation</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">46%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">50%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">50%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">55%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Oozing/Vesiculation/ Crusting</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">36%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">41%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">8%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">10%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Scaling and Dryness</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">65%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">22%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">87%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">58%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">64%</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Stinging/Burning</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">23%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">73%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">96%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">23%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">23%</p> </td> </tr> </tbody> </table></div>

In the trial for upper extremity lesions, itching and scabbing occurred in 8% and 4%, respectively, of the subjects in the LEVULAN KERASTICK photodynamic therapy group. No subjects in the vehicle group reported itching or scabbing.

Common ( >2%, <10%) local cutaneous adverse reactions for face, scalp and upper extremities in the LEVULAN KERASTICK topical solution group included wheal, scabbing, pustules, ulceration, bleeding, tenderness and dysesthesia.

Uncommon (<2%) local cutaneous adverse reactions for face, scalp and upper extremities in the LEVULAN KERASTICK topical solution group were flaking, pain, peeling, perilesional pruritic rash, excoriation and blistering.

Common ( >2%, <10%) adverse reactions not limited to the application site for upper extremities and occurring more frequently in the LEVULAN KERASTICK topical solution group than in the vehicle group were sinusitis, squamous cell carcinoma, and squamous cell carcinoma of skin.

The following adverse reactions have been reported during post-approval use of LEVULAN KERASTICK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous system disorders:  transient amnestic episodes

There have been no formal studies of the interaction of LEVULAN KERASTICK topical solution with any other drugs, and no drug-specific interactions were noted during any of the controlled clinical trials. It is, however, possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with LEVULAN KERASTICK topical solution [see Warnings and Precautions (5.2)] .

{ "type": "p", "children": [], "text": "There have been no formal studies of the interaction of LEVULAN KERASTICK topical solution with any other drugs, and no drug-specific interactions were noted during any of the controlled clinical trials. It is, however, possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with LEVULAN KERASTICK topical solution\n \n [see\n \n Warnings and Precautions (5.2)]\n \n .\n\n " }

Risk Summary

Limited available data with LEVULAN KERASTICK topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Animal developmental toxicology studies were not conducted with aminolevulinic acid.  LEVULAN KERASTICK solution has low systemic absorption following topical administration, and the risk of maternal use resulting in fetal exposure to the drug is unknown [see Clinical Pharmacology (12.3)].

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Risk Summary

There are no data on the presence of LEVULAN KERASTICK topical solution in either human or animal milk, the effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LEVULAN KERASTICK topical solution and any potential adverse effects on the breastfeeding child from LEVULAN KERASTICK topical solution or from the underlying maternal condition.

The safety and effectiveness in pediatric patients below the age of 18 have not been established. Actinic keratosis is not a disease generally seen in the pediatric population.

Of the 512 subjects in Phase 3 clinical trials of LEVULAN KERASTICK topical solution, 63% (321/512) were 65 years old and over, while 24% (123/512) were 75 years old and over.  No overall differences in safety or substantial differences in effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

In the event that the drug is ingested, monitoring and supportive care are recommended. The patient should be advised to avoid incidental exposure to intense light sources for at least 40 hours after ingestion.  The consequences of exceeding the recommended topical dosage are unknown.

There is no information on overdose of blue light from the BLU-U Blue Light Photodynamic Therapy Illuminator following LEVULAN KERASTICK topical solution application.

LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%, a porphyrin precursor, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone.

{ "type": "p", "children": [], "text": "LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%, a porphyrin precursor, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone." }

ALA HCl is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil.

{ "type": "p", "children": [], "text": "ALA HCl is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil." }

The chemical name for ALA HCl is 5-amino-4-oxopentanoic acid hydrochloride (MW = 167.59). The structural formula is represented below:

{ "type": "p", "children": [], "text": "The chemical name for ALA HCl is 5-amino-4-oxopentanoic acid hydrochloride (MW = 167.59). The structural formula is represented below:" }

The LEVULAN KERASTICK for topical solution applicator is a two-component system consisting of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle comprising alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol. The other ampule contains 354 mg of aminolevulinic acid HCl as a dry solid. The applicator tube is enclosed in a protective cardboard sleeve and cap. The 20% topical solution is prepared just prior to the time of use by breaking the ampules and mixing the contents by shaking the LEVULAN KERASTICK applicator. “LEVULAN KERASTICK for topical solution” refers to the drug product in its unmixed state, “LEVULAN KERASTICK topical solution” refers to the mixed drug product (in the applicator tube or after application), and “LEVULAN KERASTICK” refers to the applicator only.

{ "type": "p", "children": [], "text": "The LEVULAN KERASTICK for topical solution applicator is a two-component system consisting of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle comprising alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol. The other ampule contains 354 mg of aminolevulinic acid HCl as a dry solid. The applicator tube is enclosed in a protective cardboard sleeve and cap. The 20% topical solution is prepared just prior to the time of use by breaking the ampules and mixing the contents by shaking the LEVULAN KERASTICK applicator. “LEVULAN KERASTICK for topical solution” refers to the drug product in its unmixed state, “LEVULAN KERASTICK topical solution” refers to the mixed drug product (in the applicator tube or after application), and “LEVULAN KERASTICK” refers to the applicator only." }

Following the application of LEVULAN KERASTICK topical solution, photosensitization occurs through the metabolic conversion of aminolevulinic acid to protoporphyrin IX (PpIX), a photosensitizer, which accumulates in the skin.

When exposed to light of appropriate wavelength and energy, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent upon the simultaneous presence of oxygen.  The absorption of light results in an excited state of porphyrin molecules, and subsequent spin transfer from photoreactive porphyrins to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals.  LEVULAN KERASTICK Photodynamic Therapy of actinic keratoses is the combination of photosensitization by application of the LEVULAN KERASTICK topical solution to the lesions and subsequent illumination with BLU-U Blue Light Photodynamic Therapy Illuminator.

ALA does not exhibit fluorescence, while PpIX has a high fluorescence yield.  Time-dependent changes in surface fluorescence have been used to determine PpIX accumulation and clearance in actinic keratoses and perilesional skin after application of the LEVULAN KERASTICK topical solution in 12 subjects.  Peak fluorescence intensity was reached in 11 ± 1 hr in actinic keratoses and 12 ± 1 hr in perilesional skin.  The mean clearance half-life of fluorescence for lesions was 30 ± 10 hr and 28 ± 6 hr for perilesional skin. The fluorescence in perilesional skin was similar to that in actinic keratoses.  Therefore, the LEVULAN KERASTICK topical solution should only be applied to the affected skin.

Two human pharmacokinetic (PK) studies were conducted in subjects with minimally to moderately thick actinic keratoses on the upper extremities, having at least 6 lesions on one upper extremity and at least 12 lesions on the other upper extremity.  A single dose comprising of two topical applications of LEVULAN KERASTICK topical solution (each containing 354 mg ALA HCl) were directly applied to the lesions and occluded for 3 hours prior to light treatment.

The first PK study was conducted in 29 subjects and PK parameters of ALA were assessed. The baseline-corrected mean ± SD of the maximum concentration (C max) of ALA was 249.9 ± 694.5 ng/mL and the median time to reach C max(T max) was 2 hr post dose.  The mean ± SD exposure to ALA, as expressed by area under the concentration time curve (AUC t) was 669.9 ± 1610 ng∙hr/mL.  The mean ± SD elimination half-life (T 1/2) of ALA was 5.7 ± 3.9 hr.

A second PK study was conducted in 14 subjects and PK parameters of ALA and PpIX were measured.  The baseline-corrected PpIX concentrations were negative in at least 50% of samples in 50% (7/14) subjects and AUC could not be estimated reliably.   The baseline-corrected mean ± SD of C maxfor ALA and PpIX was 95.6 ± 120.6 ng/mL and 0.95 ± 0.71 ng/mL, respectively.  The median T maxof ALA and PpIX was 2 hr post dose and 12 hr post dose, respectively.  The mean AUC tof ALA was 261.1 ± 229.3 ng∙hr/mL.  The mean ± SD T 1/2of ALA was 8.5 ± 6.7 hr.

No carcinogenicity testing has been carried out using ALA. No evidence of mutagenic effects was seen in four studies conducted with ALA to evaluate this potential. In the Salmonella-Escherichia coli/mammalian microsome reverse mutation assay (Ames mutagenicity assay), no increases in the number of revertants were observed with any of the tester strains. In the Salmonella-Escherichia coli/mammalian microsome reverse mutation assay in the presence of solar light radiation (Ames mutagenicity assay with light), ALA did not cause an increase in the number of revertants per plate of any of the tester strains in the presence or absence of simulated solar light. In the L5178Y TK± mouse lymphoma forward mutation assay, ALA was evaluated as negative with and without metabolic activation under the study conditions. PpIX formation was not demonstrated in any of these in vitro studies. In the in vivo mouse micronucleus assay, ALA was considered negative under the study exposure conditions. In contrast, at least one report in the literature has noted genotoxic effects in cultured rat hepatocytes after ALA exposure with PpIX formation. Other studies have documented oxidative DNA damage in vivo and in vitro as a result of ALA exposure.

No assessment of effects of ALA HCl on fertility has been performed in laboratory animals. It is unknown what effects systemic exposure to ALA HCl might have on fertility or reproductive function.

LEVULAN KERASTICK for topical solution plus blue light at 6-10.9 J/cm 2, has been used to treat actinic keratoses of the face or scalp in 342 subjects in seven clinical trials. Phase 3 trials ALA-018 and ALA-019 were two, identically designed, multicenter, two-arm trials using LEVULAN KERASTICK topical solution plus illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator for 1000 seconds (16 minutes and 40 seconds) for a nominal exposure of 10 J/cm 2.  Subjects were excluded from these trials who had a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, photodermatosis, or inherited or acquired coagulation defects. A minimum of 4 and a maximum of 15 clinically typical, discrete, Grade 1 (slightly palpable actinic keratoses: better felt than seen), or Grade 2 (moderately thick actinic keratoses: easily seen and felt) target actinic keratoses were identified (see Table 5for definitions). Target lesions on the face or on the scalp, but not on both locations in the same subject, received treatment. The subjects were randomized to receive treatment either with the LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator or vehicle plus BLU-U Blue Light Photodynamic Therapy Illuminator. Subjects were randomized at a 3 to 1 LEVULAN KERASTICK topical solution to vehicle ratio. A total of 243 subjects were enrolled in two Phase 3 trials (ALA-018, ALA-019). Lesions were designated as cleared (complete response) if the lesion had completely cleared and adherent scaling plaques of actinic keratoses were no longer evident on the surface of the treated skin when palpated. The percentage of subjects in whom 75% or more of treated lesions were cleared, and the percentage of subjects in whom 100% of treated lesions were cleared (Complete Responders), for each trial 8 weeks after treatment are shown in Table 4.

<div class="scrollingtable"><table width="100%"> <caption> <span>TABLE 4 - Subject Responses at Week 8</span> </caption> <col width="17%"/> <col width="30%"/> <col width="12%"/> <col width="30%"/> <col width="12%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">ALA-018</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="middle"> <p class="First"> <span class="Bold">ALA-019</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">LEVULAN KERASTICK Topical Solution + PDT</span> </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">Vehicle + PDT</span> </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">LEVULAN KERASTICK Topical Solution + PDT</span> </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Bold">Vehicle + PDT</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule" colspan="4" valign="middle"> <p class="First"> Subjects with <span class="Underline">&gt;</span>75% of AK Lesions Cleared </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Total No. Subjects</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">68/87 (78%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">6/29 (21%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">71/93 (76%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">8/32 (25%)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Subjects with Face Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">57/71 (80%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2/21 (10%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">57/67 (85%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">7/19 (37%)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Patients with Scalp Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">11/16 (69%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4/8 (50%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">14/26 (54%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">1/13 (8%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule" colspan="4" valign="middle"> <p class="First">Complete Responders</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Total No. Subjects</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">60/87 (69%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4/29 (14%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">59/93 (63%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4/32 (13%)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Subjects with Face Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">49/71 (69%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2/21 (10%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">47/67 (70%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4/19 (21%)</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Subjects with Scalp Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">11/16 (69%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2/8 (25%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">12/26 (46%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0/13 (0%)</p> </td> </tr> </tbody> </table></div>

Because ALA-018 and ALA-019 had identical protocols, the combined results from the two trials are shown in the following tables. For actinic keratoses with a variety of thicknesses (excluding very thick, Grade 3 actinic keratoses which were not studied in the Phase 3 trials), LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator is more effective than vehicle plus BLU-U Blue Light Photodynamic Therapy Illuminator, but as shown in Table 5, the percentage of lesions with complete responses at 8 weeks after treatment with LEVULAN KERASTICK topical solution plus blue light illumination was lower for those lesions that were thicker at baseline. Efficacy of LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator on higher grade lesions was not studied in the Phase 3 clinical efficacy trials.

<div class="scrollingtable"><table width="100%"> <caption> <span>TABLE 5  Lesions Complete Responses at Week 8 for Different Lesion Grades</span> </caption> <col width="57%"/> <col width="26%"/> <col width="17%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Lesion Grade</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">LEVULAN</span> <br/> <span class="Bold">KERASTICK</span> <br/> <span class="Bold">Topical Solution + PDT</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Vehicle + PDT</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Grade 1 <br/> (slightly palpable actinic keratoses: better felt than seen) </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">666/756 (88%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">122/302 (40%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Grade 2 <br/> (moderately thick actinic keratoses: easily seen and felt) </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">495/632 (78%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">52/199 (26%)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Grade 3 <br/> (very thick and/or hyperkeratotic actinic keratoses) </p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0</p> </td> </tr> </tbody> </table></div>

Those subjects who were not Complete Responders at Week 8 had retreatment of the persistent target lesions at Week 8. Among the subjects undergoing retreatment, efficacy results seen at 12 weeks after the initial treatment, i.e., at 4 weeks after the second treatment, are shown in Table 6.

<div class="scrollingtable"><table width="100%"> <caption> <span>TABLE 6  Complete Responders at Week 12, Among Subjects Receiving Two Treatments</span> </caption> <col width="30%"/> <col width="53%"/> <col width="17%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">LEVULAN KERATICK Topical Solution + PDT</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Vehicle + PDT</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Total No. Subjects</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">24/56 (43%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2/49 (4%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Subjects with Face Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">21/40 (53%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2/31 (6%)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Subjects with Scalp Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">3/16 (19%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">0/18 (0%)</p> </td> </tr> </tbody> </table></div>

The efficacy results seen at 12 weeks after treatment, which include the results at 12 weeks for those subjects who received a single treatment as well as the results at 12 weeks for those subjects who received a second treatment at week 8, are shown in Table 7.

<div class="scrollingtable"><table width="100%"> <caption> <span>TABLE 7  Subject Responses at Week 12, Among Subjects Who Received One or Two Treatments</span> </caption> <col width="34%"/> <col width="41%"/> <col width="25%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">LEVULAN KERASTICK</span> <br/> <span class="Bold">Topical Solution + PDT</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Vehicle + PDT</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First">Subjects with <span class="Underline">&gt;</span>75% of Actinic Keratosis Lesions Cleared </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Total No. Subjects</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">158/180 (88%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">12/61 (20%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Subjects with Face Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">127/138 (92%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">8/40 (20%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Subjects with Scalp Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">31/42 (74%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">4/21 (19%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="middle"> <p class="First">Complete Responders</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Total No. Subjects</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">129/180 (72%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">7/61 (11%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Subjects with Face Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">108/138 (78%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">5/40 (13%)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">Subjects with Scalp Lesions</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">21/42 (50%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">2/21 (10%)</p> </td> </tr> </tbody> </table></div>

Among Complete Responders at Week 8, 93% (in ALA-018) and 83% (in ALA-019) maintained complete response at Week 12. Among subjects with scalp lesions, the percentage of subjects with 100% of actinic keratosis lesions having complete response declined from Week 8 (55%) to Week 12 (50%), because there were more subjects with scalp lesions with 100% of actinic keratosis lesions cleared at Week 8 who had a recurrence of a lesion by Week 12 than there were subjects with scalp lesions who had retreatment of persistent lesions at Week 8 and who then achieved 100% of actinic keratosis lesions cleared by Week 12. Subjects did not receive follow-up past 12 weeks after the initial treatment.

Subject outcomes recorded in the two Phase 3 trials are depicted in the following flowchart, in which Complete Responders are designated clear.  Seven subjects in the active treatment arm and three subjects in the vehicle treatment arm withdrew or were lost to follow-up. Three subjects in the active treatment arm were treated at baseline but did not return for evaluation until Week 12. One subject in the active treatment arm and two in the vehicle treatment arm who were not clear at Week 8 did not receive retreatment.

An open-label trial enrolled 110 subjects with 4 to 10 clinically typical, discrete actinic keratoses on the face or scalp, but not both locations.  The target lesions were treated with the LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator. Any treated lesions that were not clear at Month 2 (Week 8) were re-treated. Subjects were followed monthly for 12 months.  Lesions were designated as cleared if the lesion had completely cleared and adherent scaling plaques of actinic keratoses were no longer evident on the surface of the treated skin when palpated. The percentages of subjects in whom 100% of treated lesions were cleared (Complete Responders) by month, starting at Month 3 (Week 12), are shown in Figure 4.  Of the 72 subjects with 100% of treated lesions cleared (Complete Responders) at Month 3, 53% had a recurrence by Month 12.  A total of 748 individual lesions were treated; 539 were treated once and 209 were treated twice.  At Month 3, 624 lesions (83%) were cleared.  From Month 3 through Month 12 of the trial, 476 lesions (64%) remained clear. See Figure 5.  Of the 624 treated lesions determined cleared at Month 3, 24% had recurred by Month 12, while 5% were lost to follow-up and their recurrence status is unknown.

The safety and efficacy of LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator at 10J/cm 2to treat actinic keratoses of the upper extremities has been evaluated in a multicenter randomized, parallel-group, evaluator-blinded, vehicle-controlled trial of 269 subjects.

In this trial (CP0108), 269 subjects with 4 -15 mild to moderate actinic keratoses on the upper extremities (dorsal hand/forearm area between the elbow and the base of the fingers) were treated with LEVULAN KERASTICK topical solution and BLU-U Blue Light Photodynamic Therapy Illuminator. Subjects ranged from 45 to 90 years of age (mean 68 years) and 90% had Fitzpatrick Skin Type I, II or III.  No subjects had Fitzpatrick Skin Type V or VI. Approximately 70% of subjects were male and all subjects were Caucasian.

Subjects were randomized to treatment in a 1:1 ratio to receive either LEVULAN KERASTICK topical solution or vehicle. Treatment was applied to 4-15 lesions on one dorsal hand/forearm on each subject, and occluded for the three-hour incubation period before treatment with 10 J/cm 2blue light delivered at 10 mW/cm 2.   Treatment was repeated at Week 8 if any actinic keratosis lesions were present in the treatment area.

The primary endpoint was the proportion of subjects with complete clearance of all actinic keratosis lesions in the treatment area 12 weeks after initial treatment. The results of the trial are presented in Table 8.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 8 – Number and Percentage of Subjects with Actinic Keratosis of the Upper Extremities Achieving Complete Clearance at Week 12</span> </caption> <col width="18%"/> <col width="51%"/> <col width="31%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="middle"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">LEVULAN KERASTICK</span> <br/> <span class="Bold">Topical Solution + PDT</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Vehicle + PDT</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">CP0108</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">42/135 (31%)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">17/134 (13%)</p> </td> </tr> </tbody> </table></div>

Subject outcomes recorded in the trial of the upper extremities are depicted in the following flowchart.

Subjects who achieved complete clearance at Week 12 entered a 12-month follow-up period. Subjects who received LEVULAN KERASTICK topical solution with blue light and achieved complete clearance at Week 12 in CP0108A had a recurrence rate of 58% (22/38) at 12 months, where recurrence was defined as the presence of at least one previously treated lesion in the treatment area at any visit during the 12-month follow-up period.

The LEVULAN KERASTICK for topical solution, 20%, is supplied in packs of 6 applicators.  Each LEVULAN KERASTICK applicator is for single use and consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains 354 mg of aminolevulinic acid HCl. The applicator is covered with a protective cardboard sleeve and cap.

Carton of 6 LEVULAN KERASTICK for topical solution, 20% applicators           67308-101-06

Store between 20° - 25 °C (68° - 77 °F); excursions permitted to 15°- 30 °C (59° - 86 °F) [See USP Controlled Room Temperature]. The LEVULAN KERASTICK topical solution should be used immediately following preparation (dissolution). Solution application must be completed within 2 hours of preparation. An applicator that has been prepared must be discarded 2 hours after mixing (dissolving) and a new LEVULAN KERASTICK applicator used, if needed.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)." }

Transient Amnestic Episodes

{ "type": "p", "children": [], "text": "\nTransient Amnestic Episodes\n" }

Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed\n \n [see\n \n Warnings and Precautions (5.1)].\n \n \n" }

Photosensitivity

{ "type": "p", "children": [], "text": "\nPhotosensitivity\n" }

Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed\n \n [see\n \n Warnings and Precautions (5.2)].\n \n \n" }

Advise patients that after LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and that they should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Advise patients that after LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and that they should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions\n \n [see\n \n Warnings and Precautions (5.2)].\n \n \n" }

Advise patients to protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Advise patients sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Advise patients to protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Advise patients sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin\n \n [see\n \n Warnings and Precautions (5.2)].\n \n \n" }

If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, advise patients to call the doctor. Advise patient to continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, advise patients to call the doctor. Advise patient to continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced\n \n [see\n \n Warnings and Precautions (5.2)].\n \n \n" }

Advise patients to avoid certain medications that may enhance the phototoxic reaction to PDT [see Drug Interactions (7)] .

{ "type": "p", "children": [], "text": "Advise patients to avoid certain medications that may enhance the phototoxic reaction to PDT\n \n [see\n \n Drug Interactions (7)]\n \n .\n\n " }

Common Adverse Reactions Inform patients that treatment with LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator may result in sensitivity to light, skin irritation and local skin reactions including erythema, edema, stinging/burning, scaling, crusting, oozing, vesiculation, wheal, scabbing, pustules, ulceration, itching, erosion, hypo/hyperpigmentation, bleeding, tenderness, dysesthesia, and dryness.

{ "type": "p", "children": [], "text": "\nCommon Adverse Reactions\n Inform patients that treatment with LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator may result in sensitivity to light, skin irritation and local skin reactions including erythema, edema, stinging/burning, scaling, crusting, oozing, vesiculation, wheal, scabbing, pustules, ulceration, itching, erosion, hypo/hyperpigmentation, bleeding, tenderness, dysesthesia, and dryness.\n\n " }

LEVULAN, KERASTICK, KERASTICK KRUSHER, BLU-U, and DUSA are registered trademarks of DUSA Pharmaceuticals, Inc., a Sun Pharma company © 2020 Sun Pharmaceutical Industries, Inc. All rights reserved.

{ "type": "p", "children": [], "text": "LEVULAN, KERASTICK, KERASTICK KRUSHER, BLU-U, and DUSA are registered trademarks of DUSA Pharmaceuticals, Inc., a Sun Pharma company © 2020 Sun Pharmaceutical Industries, Inc. All rights reserved." }

{ "type": "", "children": [], "text": "" }

Sun Pharmaceutical Industries, Inc.

{ "type": "p", "children": [], "text": "Sun Pharmaceutical Industries, Inc." }

Princeton, NJ

{ "type": "p", "children": [], "text": "Princeton, NJ" }

1-877-533-3872

{ "type": "p", "children": [], "text": "1-877-533-3872" }

<div class="scrollingtable"><table cellpadding="0.4pt" cellspacing="0pt" width="100%"> <col width="100%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">PATIENT INFORMATION</span> <br/> <span class="Bold">LEVULAN <span class="Sup">®</span>KERASTICK <span class="Sup">®</span>(LEV-you-lan KER-rah-stick) </span> <br/> <span class="Bold">(aminolevulinic acid HCl)</span> <br/> <span class="Bold">for topical solution, 20%</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Important:</span>LEVULAN KERASTICK is for use as an in-office treatment. LEVULAN KERASTICK treatment is given by a healthcare provider only and is not for use at home. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">What is LEVULAN KERASTICK?</span> <br/> <br/> LEVULAN KERASTICK is a prescription medicine used on the skin (topical) with blue light treatment (BLU-U Blue Light Photodynamic Therapy or PDT) for the treatment of minimally to moderately thick actinic keratoses (AK’s) of the face, scalp, or upper arms. <br/> <br/> It is not known if LEVULAN KERASTICK is safe and effective in children under 18 years of age. </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Who should not receive LEVULAN KERASTICK treatment?</span> <br/> <br/> <span class="Bold">Do not receive LEVULAN KERASTICK treatment if you:</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">● are allergic to aminolevulinic acid HCl or to any of the ingredients in LEVULAN KERASTICK. See the end of this leaflet for a complete list of ingredients in LEVULAN KERASTICK. </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">● have porphyria or are allergic to porphyrins</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <p class="First">● have a skin sensitivity to blue light</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Before receiving LEVULAN KERASTICK treatment, tell your healthcare provider about all of your medical conditions, including if you:  </span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">● have blood clotting problems. </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">● are pregnant or plan to become pregnant. It is not known if LEVULAN KERASTICK will harm your unborn baby.</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">● are breastfeeding or plan to breastfeed. It is not known if LEVULAN KERASTICK passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during LEVULAN KERASTICK treatment. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Tell your healthcare provider about all of the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. LEVULAN KERASTICK and other medicines may affect each other causing side effects.  </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">How will I receive LEVULAN KERASTICK treatment?</span> </p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">● <span class="Bold">LEVULAN KERASTICK treatment is received in 2 parts:</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">○ Your healthcare provider will apply LEVULAN KERASTICK topical solution to your skin lesions. You should not wash the treated areas before you return to your healthcare provider for blue light treatment. </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">○ After the prescribed amount of time you will return to your healthcare provider for blue light treatment. Call your healthcare provider if you cannot return for blue light treatment during the prescribed time after LEVULAN KERASTICK topical solution has been applied. If you cannot return for blue light treatment, avoid sunlight and bright indoor light for at least 40 hours after LEVULAN KERASTICK topical solution has been applied. </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">● During blue light treatment, you will likely feel tingling, stinging, prickling, or burning of the treated areas.</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">What should I avoid during LEVULAN KERASTICK treatment?</span> <br/> <br/> <span class="Bold">After LEVULAN KERASTICK topical solution is applied to your skin</span>you should avoid sunlight or bright indoor light (such as examination lights, operating room lights, tanning beds, or lights that are close to you) for 40 hours. During this time, the treated areas of your skin will become sensitive to light (photosensitive).  <br/> <br/> Exposure to light during this time may cause you to feel a burning or stinging sensation and may cause your treated lesions to become red or swollen. You should wear appropriate protective apparel such as a wide-brimmed hat, long sleeve shirt, and gloves to protect your treated skin from sunlight and other bright light.  <br/> <br/> <span class="Bold">Sunscreen will not protect the treated areas of your skin against sensitivity to light.</span> <br/> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of LEVULAN KERASTICK?</span> <br/> <br/> <span class="Bold">LEVULAN KERASTICK may cause serious side effects, including:</span> <br/> </p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">● <span class="Bold">Temporary memory problems.</span>Temporary memory problems have happened during treatment with LEVULAN KERASTICK in combination with BLU-U <span class="Sup">®</span>Blue Light Photodynamic Therapy Illuminator. You or your family members or caregiver should call your healthcare provider right away if you develop any problems with memory, confusion, or disorientation during treatment. </p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">● <span class="Bold">Sensitivity to light (photosensitivity).</span>See, “What should I avoid during LEVULAN KERASTICK treatment?” </p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">● <span class="Bold">Skin irritation.</span>LEVULAN KERASTICK topical solution contains alcohol and may cause skin irritation if covered or bandaged for longer than 3 hours, </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">The common side effects of LEVULAN KERASTICK include:</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First"> ● Local skin reactions including redness, swelling, stinging and burning, scaling, crusting, oozing, pustules, welts, scabbing, itching, erosion, changes in skin color, bleeding, tenderness, changes in the sense of touch, and dryness. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">These are not all the possible side effects of LEVULAN KERASTICK. <br/> <br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">General Information about LEVULAN KERASTICK</span> <br/> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist and healthcare provider for information about LEVULAN KERASTICK that is written for health professionals.  </p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">What are the Ingredients in LEVULAN KERASTICK?</span> <br/> <br/> <span class="Bold">Active ingredient:</span>aminolevulinic acid HCl <br/> <br/> <span class="Bold">Inactive ingredients:</span>alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, polyethylene glycol <br/> <br/> Manufactured by: <br/> Sun Pharmaceutical Industries, Inc., Billerica, MA 01821  <br/> <br/> For more information call 1-877-533-3872 <br/> www.levulanhcp.com </p> <p> <br/> This Patient Information has been approved by the U.S. Food and Drug Administration. </p> <p>Revised: 01/2020.</p> <p>PM-US-LEV-0389 LAB-0529 REV E</p> <a name="id1537234596"></a><img alt="Levulan-10" src="/dailymed/image.cfm?name=Levulan-10.jpg&amp;setid=e45cc371-9ebc-4904-12bc-65cb4e2817ad"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"0.4pt\" cellspacing=\"0pt\" width=\"100%\">\n<col width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">PATIENT INFORMATION</span>\n<br/>\n<span class=\"Bold\">LEVULAN\n \n <span class=\"Sup\">®</span>KERASTICK\n \n <span class=\"Sup\">®</span>(LEV-you-lan KER-rah-stick)\n \n </span>\n<br/>\n<span class=\"Bold\">(aminolevulinic acid HCl)</span>\n<br/>\n<span class=\"Bold\">for topical solution, 20%</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important:</span>LEVULAN KERASTICK is for use as an in-office treatment. LEVULAN KERASTICK treatment is given by a healthcare provider only and is not for use at home.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is LEVULAN KERASTICK?</span>\n<br/>\n<br/> LEVULAN KERASTICK is a prescription medicine used on the skin (topical) with blue light treatment (BLU-U Blue Light Photodynamic Therapy or PDT) for the treatment of minimally to moderately thick actinic keratoses (AK’s) of the face, scalp, or upper arms. \n <br/>\n<br/> It is not known if LEVULAN KERASTICK is safe and effective in children under 18 years of age.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Who should not receive LEVULAN KERASTICK treatment?</span>\n<br/>\n<br/>\n<span class=\"Bold\">Do not receive LEVULAN KERASTICK treatment if you:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">● are allergic to aminolevulinic acid HCl or to any of the ingredients in LEVULAN KERASTICK. See the end of this leaflet for a complete list of ingredients in LEVULAN KERASTICK. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">● have porphyria or are allergic to porphyrins</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">● have a skin sensitivity to blue light</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Before receiving LEVULAN KERASTICK treatment, tell your healthcare provider about all of your medical conditions, including if you:  </span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">● have blood clotting problems. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">● are pregnant or plan to become pregnant. It is not known if LEVULAN KERASTICK will harm your unborn baby.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">● are breastfeeding or plan to breastfeed. It is not known if LEVULAN KERASTICK passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during LEVULAN KERASTICK treatment. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Tell your healthcare provider about all of the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. LEVULAN KERASTICK and other medicines may affect each other causing side effects. \n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How will I receive LEVULAN KERASTICK treatment?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">●\n \n <span class=\"Bold\">LEVULAN KERASTICK treatment is received in 2 parts:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">○ Your healthcare provider will apply LEVULAN KERASTICK topical solution to your skin lesions. You should not wash the treated areas before you return to your healthcare provider for blue light treatment. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">○ After the prescribed amount of time you will return to your healthcare provider for blue light treatment. Call your healthcare provider if you cannot return for blue light treatment during the prescribed time after LEVULAN KERASTICK topical solution has been applied. If you cannot return for blue light treatment, avoid sunlight and bright indoor light for at least 40 hours after LEVULAN KERASTICK topical solution has been applied. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">● During blue light treatment, you will likely feel tingling, stinging, prickling, or burning of the treated areas.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What should I avoid during LEVULAN KERASTICK treatment?</span>\n<br/>\n<br/>\n<span class=\"Bold\">After LEVULAN KERASTICK topical solution is applied to your skin</span>you should avoid sunlight or bright indoor light (such as examination lights, operating room lights, tanning beds, or lights that are close to you) for 40 hours. During this time, the treated areas of your skin will become sensitive to light (photosensitive).  \n <br/>\n<br/> Exposure to light during this time may cause you to feel a burning or stinging sensation and may cause your treated lesions to become red or swollen. You should wear appropriate protective apparel such as a wide-brimmed hat, long sleeve shirt, and gloves to protect your treated skin from sunlight and other bright light.  \n <br/>\n<br/>\n<span class=\"Bold\">Sunscreen will not protect the treated areas of your skin against sensitivity to light.</span>\n<br/>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of LEVULAN KERASTICK?</span>\n<br/>\n<br/>\n<span class=\"Bold\">LEVULAN KERASTICK may cause serious side effects, including:</span>\n<br/>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">●\n \n <span class=\"Bold\">Temporary memory problems.</span>Temporary memory problems have happened during treatment with LEVULAN KERASTICK in combination with BLU-U\n \n <span class=\"Sup\">®</span>Blue Light Photodynamic Therapy Illuminator. You or your family members or caregiver should call your healthcare provider right away if you develop any problems with memory, confusion, or disorientation during treatment.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">●\n \n <span class=\"Bold\">Sensitivity to light (photosensitivity).</span>See, “What should I avoid during LEVULAN KERASTICK treatment?”\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">●\n \n <span class=\"Bold\">Skin irritation.</span>LEVULAN KERASTICK topical solution contains alcohol and may cause skin irritation if covered or bandaged for longer than 3 hours,\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">The common side effects of LEVULAN KERASTICK include:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\"> ● Local skin reactions including redness, swelling, stinging and burning, scaling, crusting, oozing, pustules, welts, scabbing, itching, erosion, changes in skin color, bleeding, tenderness, changes in the sense of touch, and dryness. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">These are not all the possible side effects of LEVULAN KERASTICK. \n <br/>\n<br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General Information about LEVULAN KERASTICK</span>\n<br/>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist and healthcare provider for information about LEVULAN KERASTICK that is written for health professionals. \n \n </p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the Ingredients in LEVULAN KERASTICK?</span>\n<br/>\n<br/>\n<span class=\"Bold\">Active ingredient:</span>aminolevulinic acid HCl \n <br/>\n<br/>\n<span class=\"Bold\">Inactive ingredients:</span>alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, polyethylene glycol \n <br/>\n<br/> Manufactured by: \n <br/> Sun Pharmaceutical Industries, Inc., Billerica, MA 01821  \n <br/>\n<br/> For more information call 1-877-533-3872 \n <br/> www.levulanhcp.com\n \n </p>\n<p>\n<br/> This Patient Information has been approved by the U.S. Food and Drug Administration.\n </p>\n<p>Revised: 01/2020.</p>\n<p>PM-US-LEV-0389 LAB-0529 REV E</p>\n<a name=\"id1537234596\"></a><img alt=\"Levulan-10\" src=\"/dailymed/image.cfm?name=Levulan-10.jpg&amp;setid=e45cc371-9ebc-4904-12bc-65cb4e2817ad\"/></td>\n</tr>\n</tbody>\n</table></div>" }

LEVULAN ®KERASTICK ® (aminolevulinic acid HCl) for Topical Solution, 20% SINGLE USE APPLICATOR 1.5 mL NDC 67308-101-01      A      ↑ CRUSH  HERE      ↓      A LOT NO.: EXP. DATE:       B       ↑ CRUSH  HERE      ↓      B MANUFACTURED BY: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 LAB-0528 AW REV F

{ "type": "p", "children": [], "text": "\nLEVULAN\n \n ®KERASTICK\n \n ®\n (aminolevulinic acid HCl) for Topical Solution, 20% \n \n SINGLE USE APPLICATOR 1.5 mL \n \n NDC 67308-101-01 \n \n      A \n      ↑ \n CRUSH \n  HERE \n      ↓ \n      A \n \n LOT NO.: \n \n EXP. DATE: \n \n       B \n       ↑ \n CRUSH \n  HERE \n      ↓ \n      B \n \n\n MANUFACTURED BY: \n Sun Pharmaceutical Industries, Inc. \n Billerica, MA 01821 \n \n LAB-0528 AW REV F\n\n " }

NDC 67308-101-06 LEVULAN ® KERASTICK ® (aminolevulinic acid HCl) for Topical Solution, 20% 6 SINGLE USE APPLICATORS/1.5 ML EACH FOR TOPICAL USE ONLY NOT FOR USE IN EYES FOR ADMINISTRATION BY HEALTH PROFESSIONAL ONLY RX Only Each applicator contains: Active Ingredient: 354mg aminolevulinic acid HCl Inactive Ingredients: Alcohol, USP (ethanol content=48%v/v), Water, laureth-4, isopropyl alcohol and polyethylene glycol. Usual Dose:For indications, dosage, precautions, etc., see enclosed package insert. Store between 20°– 25°C (68°-77°F), excursions permitted to 15°– 30°C (59° – 86°F). [See USP Controlled Room Temperature] Use and discard within two hours after activation. Sun Pharmaceutical Industries, Inc. Billerica, MA 01821   1-877-533-3872 or 1-978-657-7500 LAB-1451 AW Rev F

{ "type": "p", "children": [], "text": "NDC 67308-101-06 \n \n\nLEVULAN\n \n ®\n\nKERASTICK\n \n ®\n (aminolevulinic acid HCl) \n for Topical Solution, 20% \n \n\n6 SINGLE USE APPLICATORS/1.5 ML EACH\n\n FOR TOPICAL USE ONLY \n \n NOT FOR USE IN EYES \n \n FOR ADMINISTRATION BY HEALTH PROFESSIONAL ONLY \n \n RX Only \n \n\nEach applicator contains:\n Active Ingredient: 354mg aminolevulinic acid HCl \n Inactive Ingredients: Alcohol, USP (ethanol content=48%v/v), Water, laureth-4, isopropyl alcohol and polyethylene glycol. \n \n\nUsual Dose:For indications, dosage, precautions, etc., see enclosed package insert. \n Store between 20°– 25°C (68°-77°F), excursions permitted to 15°– 30°C (59° – 86°F). \n [See USP Controlled Room Temperature] \n \n\nUse and discard within two hours after activation.\n\n Sun Pharmaceutical Industries, Inc. \n Billerica, MA 01821   \n 1-877-533-3872 or \n 1-978-657-7500 \n \n LAB-1451 AW Rev F\n\n " }

6 SINGLE USE APPLICATORS, 1.5 ML EACH Carefully follow the step by step directions provided in the package insert to prepare Levulan ®Kerastick ®for application. Please note the locations of the crush points “A” and “B” which are indicated by the red diamonds “♦” on each Kerastick ®.

{ "type": "p", "children": [], "text": "\n6 SINGLE USE APPLICATORS, 1.5 ML EACH\n\n Carefully follow the step by step directions provided in the package insert to prepare Levulan\n \n ®Kerastick\n \n ®for application. Please note the locations of the crush points “A” and “B” which are indicated by the red diamonds “♦” on each Kerastick\n \n ®.\n\n " }

NDC 67308-101-01 Levulan ®Kerastick ® (aminolevulinic acid HCl) for Topical Solution, 20% SINGLE USE APPLICATOR 1.5 ML LOT NO.: EXP. DATE: SAMPLE: NOT FOR SALE Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821  LAB-1411 REV.: C

{ "type": "p", "children": [], "text": "NDC 67308-101-01 \n \n Levulan\n \n ®Kerastick\n \n ®\n (aminolevulinic acid HCl) for Topical Solution, 20% \n \n SINGLE USE APPLICATOR 1.5 ML \n \n LOT NO.: \n \n EXP. DATE: \n \n SAMPLE: NOT FOR SALE \n \n Manufactured By: \n \n Sun Pharmaceutical Industries, Inc. \n Billerica, MA 01821  \n \n LAB-1411 REV.: C\n\n " }

NDC 67308-101-02 Levulan® Kerastick ® (aminolevulinic acid HCl) for Topical Solution, 20% 2 SINGLE USE APPLICATORS, 1.5 mL EACH SAMPLE NOT FOR SALE For Topical Use Only Not For Use in Eyes FOR ADMINISTRATION BY HEALTH PROFESSIONAL ONLY Rx only Carefully follow the step by step directions provided in the package to prepare Levulan ®Kerastick ®for application. Please note the locations of the crush points "A" and "B" which are indicated by the red diamonds "♦" on each Kerastick ®. CAT. NO.: LOT NO.: EXP. DATE: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821  1-877-533-3872 LAB-1462AW REV. C Each applicator contains: Active Ingredient: 354mg aminolevulinic acid HCl Inactive Ingredients: Alcohol, USP (ethanol content-48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol. Usual Dose: For indications, dosage, precautions, etc., see enclosed package insert. Store between 20°25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature] Use and discard within two hours after activation.

{ "type": "p", "children": [], "text": "\nNDC 67308-101-02\n\n\nLevulan® Kerastick\n \n ®\n (aminolevulinic acid HCl) for Topical Solution, 20% \n \n 2 SINGLE USE APPLICATORS, 1.5 mL EACH \n \n\nSAMPLE\n\nNOT FOR SALE\n\n For Topical Use Only \n \n Not For Use in Eyes \n \n FOR ADMINISTRATION BY HEALTH PROFESSIONAL ONLY \n \n Rx only \n \n Carefully follow the step by step directions provided in the package to prepare Levulan\n \n ®Kerastick\n \n ®for application. Please note the locations of the crush points \"A\" and \"B\" which are indicated by the red diamonds \"♦\" on each Kerastick\n \n ®. \n \n CAT. NO.: \n \n LOT NO.: \n \n EXP. DATE: \n \n Sun Pharmaceutical Industries, Inc. \n Billerica, MA 01821  \n 1-877-533-3872 \n LAB-1462AW REV. C \n \n Each applicator contains: \n \n Active Ingredient: 354mg aminolevulinic acid HCl \n \n Inactive Ingredients: Alcohol, USP (ethanol content-48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol. \n \n Usual Dose: \n For indications, dosage, precautions, etc., see enclosed package insert. \n \n Store between 20°25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) \n \n [See USP Controlled Room Temperature] \n \n\nUse and discard within two hours after activation.\n" }

Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery.

{ "type": "p", "children": [], "text": "Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery." }

Gleolan powder must be reconstituted prior to administration by a healthcare provider according to the following instructions:

Gleolan is for ORAL USE ONLY. The reconstituted Gleolan solution is administered according to the following steps:

For oral solution: 1,500 mg aminolevulinic acid hydrochloride (ALA HCl) lyophilized powder, equivalent to 1,170 mg aminolevulinic acid (ALA) , in a 50 mL single-dose clear, colorless, glass vial with rubber stopper. After reconstitution with 50 mL drinking water, the solution contains 30 mg per mL of aminolevulinic acid hydrochloride (equivalent to 23.4 mg per mL of aminolevulinic acid) and is clear and colorless to slightly yellowish in color.

{ "type": "p", "children": [], "text": "For oral solution: 1,500 mg aminolevulinic acid hydrochloride (ALA HCl) lyophilized powder, equivalent to 1,170 mg aminolevulinic acid (ALA) , in a 50 mL single-dose clear, colorless, glass vial with rubber stopper. After reconstitution with 50 mL drinking water, the solution contains 30 mg per mL of aminolevulinic acid hydrochloride (equivalent to 23.4 mg per mL of aminolevulinic acid) and is clear and colorless to slightly yellowish in color." }

{ "type": "ul", "children": [ "Hypersensitivity to the aminolevulinic acid (ALA) or porphyrins.[seeWarnings and Precautions (5.3)]\n", "Acute or chronic types of porphyria, due to potential ineffectiveness of the drug in these patients." ], "text": "" }

Due to the risk of phototoxic reactions, do not administer phototoxic drugs (St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period[seeDrug Interactions (7)]. Reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan.

Errors may occur with the use of Gleolan for intraoperative visualization of malignant glioma, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of tumor in patients with glioma[seeClinical Studies (14)]. Fluorescence may be seen in areas of inflammation or metastases from other tumor types.

Hypersensitivity reactions, including serious hypersensitivity reactions have occurred; these reactions include anaphylactic shock, swelling, and urticaria[seeContraindications (4),Adverse Reactions (6.2)]. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Gleolan is supported by data from 5 open label clinical studies, which included 527 patients with glioma who received ALA HCl. Adverse reactions that occurred in > 1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting. Adverse reactions occurring in the first 6 weeks after surgery in < 1% of patients were: chills, photosensitivity reaction, solar dermatitis, hypotension, abnormal liver function test, and diarrhea. One patient experienced respiratory failure due to drug overdose[seeOverdosage (10)].

Neurologic Events

Nervous system disorders occurred in 29% of patients within the first week after surgery. Events occurring in > 1% of patients included aphasia (8%), hemiparesis (7.8%), hemianopsia (3.2%), headache (2.7%), seizure (1.9%), hemiplegia (1.9%), monoparesis (1.3%) and hypoesthesia (1.1%). Brain edema occurred in < 1 % of patients in the first 6 weeks after surgery. In a randomized clinical trial (Study 3), the numbers of serious neurologic adverse events in the post operative period were higher in patients randomized to ALA fluorescence arm compared to the control arm. An imbalance was notable for the adverse events aphasia, ataxia, convulsion and hemianopsia, and is likely related to the higher amount of brain resection performed in the ALA arm. At longer follow up periods, the numbers between the two arms appeared similar[seeClinical Trials (14)].

Elevated Liver Enzymes

Worsening of ≥ 2 Common Toxicity Criteria (CTC) grades in alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) occurred in (15.8% and 11.6%, respectively) within the first week after surgery. Absolute levels ranged from 2 times to greater than 10 times the upper limit of normal (ULN) for each parameter. At 6 weeks, ALT remained elevated in 2.9% of patients (range 2 to greater than 5 × ULN), and GGT was elevated in 7.5% of patients (range 2 to greater than 10 × ULN). No cases of liver failure occurred.

The following adverse reactions are among those that have been identified during post-approval use of Gleolan outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune Disorders: anaphylactic shock, angioedema, drug eruption, urticaria, erythema.

Metabolism and Nutrition Disorders: metabolic acidosis.

Phototoxic Drugs

Patients exposed to a photosensitizing agent may experience a phototoxic skin reaction (severe sunburn). Due to the risk of possible phototoxic reactions, avoid administering phototoxic drugs such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines, and topical preparations containing ALA for 24 hours before and after administration of Gleolan.

Risk Summary

There are no available human data on Gleolan in pregnant women to inform a drug associated risk of adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral ALA HCl administration to pregnant rabbits during organogenesis at doses 3 times the maximum recommended human oral dose(seeData).

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Animal data

ALA HCl was administered to rabbits at oral doses of 15, 50 and 150 mg/kg/day [approximately 0.1, 0.6, and 3 times the maximum human recommended dose (MHRD), respectively based on AUC comparisons] from gestation days 6-18. The no-observed-adverse-effect level (NOAEL) for maternal toxicity was 50 mg/kg/day and the NOAEL for embryo-fetal developmental toxicity was 150 mg/kg/day.

Risk summary

There are no data on the presence of ALA HCl in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Gleolan and any potential adverse effects on the breastfed infant from Gleolan or from the underlying maternal condition.

Clinical Considerations

To decrease exposure to Gleolan to the breastfed infant, advise a lactating woman to pump and discard breast milk after the administration of Gleolan for 24 hours (i.e., 5 to 6 half-lives).

The safety and effectiveness of Gleolan in pediatric patients have not been established.

Of 527 subjects in clinical studies of Gleolan, 182 were 65 to < 75 years of age and 7 were ≥ 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dose adjustment is required in elderly patients.

Because approximately one third of the ALA dose is excreted in urine as parent drug, ALA clearance may be reduced in patients with renal impairment; it is not known if dose adjustment is needed[seeClinical Pharmacology (12.3)].

The contribution of the liver to the elimination of ALA following Gleolan dosing is unknown. ALA clearance may be reduced in patients with hepatic impairment; it is not known if dose adjustment is needed[seeClinical Pharmacology (12.3)].

Overdosage has been associated with respiratory insufficiency and erythema. In the event of overdose, supportive measures should be provided as necessary, including protection from strong light sources.

{ "type": "p", "children": [], "text": "Overdosage has been associated with respiratory insufficiency and erythema. In the event of overdose, supportive measures should be provided as necessary, including protection from strong light sources." }

Gleolan (aminolevulinic acid hydrochloride) is an optical imaging agent for oral solution. The 50-mL, clear vial contains 1,500 mg of lyophilized aminolevulinic acid hydrochloride powder (equivalent to 1,170 mg aminolevulinic acid). After reconstitution, the product has a concentration of 30 mg aminolevulinic acid hydrochloride per mL (equivalent to 23.4 mg aminolevulinic acid per mL). The chemical name is 5-amino-4-oxo-pentanoic acid hydrochloride. The chemical formula for aminolevulinic acid hydrochloride is C5H10ClNO3. Its molecular weight is 167.59 g/mol with the following structural formula:

ALA occurs endogenously as a metabolite that is formed in the mitochondria from succinyl-CoA and glycine. Exogenous administration of ALA leads to accumulation of the ALA metabolite PpIX in tumor cells. The reason for the accumulation of PpIX in neoplastic brain tissue is not known.

During glioma surgery, Gleolan is used with an operating microscope adapted with a blue emitting light source (power density 40-80 mW/cm2) and filters for excitation light of wavelength 375 to 440 nm, and observation at wavelengths of 620 to 710 nm. This allows tumor tissue to be visualized as red fluorescence. Tissue lacking sufficient PpIX concentrations appears blue.

The effect of the timing of the Gleolan dosing on fluorescence intensity in brain tissue is unknown. The relationship between systemic ALA plasma concentrations at the time of visualization and fluorescence intensity in brain is also unknown. The dose of 20 mg / kg provided stronger ALA-induced fluorescence in glioma tissue by both visual and spectrophotometric assessment compared to lower doses tested.

Cardiac Electrophysiology

Administration of the approved recommended dose of Gleolan did not prolong the QT interval to any clinically relevant extent.

In 12 healthy subjects, the mean half-life of ALA following the recommended dose of Gleolan solution was 0.9 ± 1.2 hours (mean ± std dev) with a range of 0.8 to 1.3 hours. Maximum concentrations of the PpIX metabolite (Tmaxfor PpIX) occurred with a median of 4 hours and a range of 1.2 to 7.8 hours. The elimination half-life of PpIX was 3.6 ± 1.8 hours (mean ± std dev) with a range of 1.2 to 7.8 hours.

Absorption

In 12 healthy subjects, the absolute bioavailability of ALA following the recommended dose of Gleolan solution was 100.0% ± 1.1 with a range of 78.5% to 131.2%. Maximum ALA plasma concentrations were reached with a median of 0.8 hour (range 0.5 – 1.0 hour).

Distribution

In in vitro experiments using ALA concentrations up to approximately 25% of the maximal concentration that occurs in plasma following the recommended dose of Gleolan solution, the mean protein binding of ALA was 12%.

Elimination

Metabolism

Exogenous ALA is metabolized to PpIX, but the fraction of administered ALA that is metabolized to PpIX is unknown. The average plasma AUC of PpIX is less than 6% of that of ALA.

Excretion

In 12 healthy subjects, excretion of parent ALA in urine in the 12 hours following administration of the recommended dose of Gleolan solution was 34 ± 8% (mean ± std dev) with a range of 27% to 57%.

Specific Populations

The effect of renal or hepatic impairment on the pharmacokinetics of ALA following Gleolan administration is unknown.

Drug Interaction Studies

In vitro studies suggest that phenytoin and other anti-convulsants may decrease cellular PpIX accumulation following Gleolan dosing.

ALA is not an inhibitor of CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A.

Carcinogenesis

No carcinogenicity studies have been conducted with Gleolan.

Mutagenesis

ALA HCl was not mutagenic in the Ames assay, HPRT-V79 mammalian cell mutagenicity test, the peripheral human lymphocyte chromosomal aberration assay and thein vivomouse micronucleus test when studies were performed in the dark or under subdued lighting.

Impairment of Fertility

No fertility studies have been conducted with Gleolan.

The efficacy of 20 mg / kg ALA HCl was evaluated in 3 clinical studies (Study 1-3) involving patients, ages 18 to 75 years old, who had a preoperative MRI compatible with high-grade glioma (WHO Grade III or IV) and were undergoing surgical resection.

{ "type": "p", "children": [], "text": "The efficacy of 20 mg / kg ALA HCl was evaluated in 3 clinical studies (Study 1-3) involving patients, ages 18 to 75 years old, who had a preoperative MRI compatible with high-grade glioma (WHO Grade III or IV) and were undergoing surgical resection." }

Study 1 was an open-label study of 33 patients with newly diagnosed high-grade glioma and Study 2 was an open-label study of 36 patients with recurrent high-grade glioma. In Studies 1 and 2, after initial debulking was carried out under white light, biopsies were obtained under fluorescent light from fluorescent and nonfluorescent sites. Presence of fluorescence (positive/negative) was compared to tumor status (true/false) using histopathology as the reference standard. True positives and false positives among fluorescent biopsies and true negatives and false negatives among nonfluorescent biopsies are provided in Table 1.

{ "type": "p", "children": [], "text": "Study 1 was an open-label study of 33 patients with newly diagnosed high-grade glioma and Study 2 was an open-label study of 36 patients with recurrent high-grade glioma. In Studies 1 and 2, after initial debulking was carried out under white light, biopsies were obtained under fluorescent light from fluorescent and nonfluorescent sites. Presence of fluorescence (positive/negative) was compared to tumor status (true/false) using histopathology as the reference standard. True positives and false positives among fluorescent biopsies and true negatives and false negatives among nonfluorescent biopsies are provided in Table 1." }

Study 3 was a randomized, multicenter study in 415 patients with a preoperative diagnosis of high-grade glioma by MRI. Patients were randomized in 1:1 ratio to ALA fluorescence arm or to white light control arm. Biopsies were obtained from tumor-core, tumor-margin and regions just distant to the tumor margins. In 349 patients high grade glioma was confirmed by a blinded central read and histopathology. The remaining patients were diagnosed with metastatic disease, abscess, low-grade glioma or other conditions.

{ "type": "p", "children": [], "text": "Study 3 was a randomized, multicenter study in 415 patients with a preoperative diagnosis of high-grade glioma by MRI. Patients were randomized in 1:1 ratio to ALA fluorescence arm or to white light control arm. Biopsies were obtained from tumor-core, tumor-margin and regions just distant to the tumor margins. In 349 patients high grade glioma was confirmed by a blinded central read and histopathology. The remaining patients were diagnosed with metastatic disease, abscess, low-grade glioma or other conditions." }

In patients with confirmed high-grade glioma randomized to the ALA fluorescence arm, presence of fluorescence at a biopsy level was compared to tumor status using histopathology as the reference standard (Table 1). In 4 patients with low-grade glioma (WHO Grade I or II) who received ALA HCl, 9 out of 10 biopsies were false negative.

{ "type": "p", "children": [], "text": "In patients with confirmed high-grade glioma randomized to the ALA fluorescence arm, presence of fluorescence at a biopsy level was compared to tumor status using histopathology as the reference standard (Table 1). In 4 patients with low-grade glioma (WHO Grade I or II) who received ALA HCl, 9 out of 10 biopsies were false negative." }

The extent of resection among patients with confirmed high-grade glioma in the ALA fluorescence arm was compared to that among patient in the control arm, with the "completeness" of resection being determined by a central blinded read of early post-surgical MRI. Percentage of patients who had "completeness" of resection was 64% in the ALA arm and 38% in the control arm, with the difference of 26% [95% CI: (16%, 36%)].

{ "type": "p", "children": [], "text": "The extent of resection among patients with confirmed high-grade glioma in the ALA fluorescence arm was compared to that among patient in the control arm, with the \"completeness\" of resection being determined by a central blinded read of early post-surgical MRI. Percentage of patients who had \"completeness\" of resection was 64% in the ALA arm and 38% in the control arm, with the difference of 26% [95% CI: (16%, 36%)]." }

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 1. Presence of Fluorescence Compared to Histopathology (biopsy level)</span> </caption> <col align="center" valign="middle" width="55%"/> <col align="center" valign="middle" width="15%"/> <col align="center" valign="middle" width="15%"/> <col align="center" valign="middle" width="15%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule"></th><th align="center" class="Rrule">Study 1 <br/> (N=297)<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></th><th align="center" class="Rrule">Study 2 <br/> (N=370)<a class="Sup" href="#footnote-1">*</a></th><th align="center" class="Rrule">Study 3 <br/> (N=479)<a class="Sup" href="#footnote-1">*</a></th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>N is Number of total (fluorescent and non-fluorescent) biopsies</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule"><span class="Bold">Number of Fluorescent Biopsies</span></td><td align="center" class="Rrule"><span class="Bold">185</span></td><td align="center" class="Rrule"><span class="Bold">354</span></td><td align="center" class="Rrule"><span class="Bold">319</span></td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><span class="Bold">True Positive</span></td><td align="center" class="Rrule"><span class="Bold">178</span></td><td align="center" class="Rrule"><span class="Bold">342</span></td><td align="center" class="Rrule"><span class="Bold">312</span></td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><span class="Bold">False Positive</span></td><td align="center" class="Rrule"><span class="Bold">7</span></td><td align="center" class="Rrule"><span class="Bold">12</span></td><td align="center" class="Rrule"><span class="Bold">7</span></td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"> </td><td align="center" class="Rrule"></td><td align="center" class="Rrule"></td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><span class="Bold">Number of Nonfluorescent Biopsies</span></td><td align="center" class="Rrule"><span class="Bold">112</span></td><td align="center" class="Rrule"><span class="Bold">16</span></td><td align="center" class="Rrule"><span class="Bold">160</span></td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><span class="Bold">True Negative</span></td><td align="center" class="Rrule"><span class="Bold">27</span></td><td align="center" class="Rrule"><span class="Bold">3</span></td><td align="center" class="Rrule"><span class="Bold">30</span></td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule"><span class="Bold">False Negative</span></td><td align="center" class="Rrule"><span class="Bold">85</span></td><td align="center" class="Rrule"><span class="Bold">13</span></td><td align="center" class="Rrule"><span class="Bold">130</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"90%\">\n<caption>\n<span>Table 1. Presence of Fluorescence Compared to Histopathology (biopsy level)</span>\n</caption>\n<col align=\"center\" valign=\"middle\" width=\"55%\"/>\n<col align=\"center\" valign=\"middle\" width=\"15%\"/>\n<col align=\"center\" valign=\"middle\" width=\"15%\"/>\n<col align=\"center\" valign=\"middle\" width=\"15%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"Lrule Rrule\"></th><th align=\"center\" class=\"Rrule\">Study 1 <br/> (N=297)<a class=\"Sup\" href=\"#footnote-1\" name=\"footnote-reference-1\">*</a></th><th align=\"center\" class=\"Rrule\">Study 2 <br/> (N=370)<a class=\"Sup\" href=\"#footnote-1\">*</a></th><th align=\"center\" class=\"Rrule\">Study 3 <br/> (N=479)<a class=\"Sup\" href=\"#footnote-1\">*</a></th>\n</tr>\n</thead>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"4\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-1\" name=\"footnote-1\">*</a>\n</dt>\n<dd>N is Number of total (fluorescent and non-fluorescent) biopsies</dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\"><span class=\"Bold\">Number of Fluorescent Biopsies</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">185</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">354</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">319</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><span class=\"Bold\">True Positive</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">178</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">342</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">312</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><span class=\"Bold\">False Positive</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">7</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">12</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">7</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"> </td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\" class=\"Rrule\"></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><span class=\"Bold\">Number of Nonfluorescent Biopsies</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">112</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">16</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">160</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><span class=\"Bold\">True Negative</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">27</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">3</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">30</span></td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\"><span class=\"Bold\">False Negative</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">85</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">13</span></td><td align=\"center\" class=\"Rrule\"><span class=\"Bold\">130</span></td>\n</tr>\n</tbody>\n</table></div>" }

Gleolan (NDC 71469 -231- 01) is supplied as 1,500 mg of lyophilized aminolevulinic acid hydrochloride powder (equivalent to 1,170 mg aminolevulinic acid), for oral solution in a 50-mL clear, colorless, glass vial with a rubber stopper and an aluminum crimp seal.

Store at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F).

Advise patients that they may experience elevated liver enzymes (ALT and GGT) within the first week after surgery. This elevation may persist after 6 weeks.

{ "type": "p", "children": [], "text": "Advise patients that they may experience elevated liver enzymes (ALT and GGT) within the first week after surgery. This elevation may persist after 6 weeks." }

Advise patients to reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan due to risk of phototoxic reactions.

{ "type": "p", "children": [], "text": "Advise patients to reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan due to risk of phototoxic reactions." }

Manufactured for and Distributed by: NX Development Corp. 870 Corporate Dr., Suite 403 Lexington, KY 40503

{ "type": "p", "children": [], "text": "Manufactured for and Distributed by: NX Development Corp. 870 Corporate Dr., Suite 403 Lexington, KY 40503" }

Product of Germany

{ "type": "p", "children": [], "text": "Product of Germany" }

APX1182

{ "type": "p", "children": [], "text": "APX1182" }

NDC 71469-231-01 Rx only

{ "type": "p", "children": [], "text": "NDC 71469-231-01 Rx only" }

Gleolan® (aminolevulinic acid hydrochloride) for oral solution

{ "type": "p", "children": [], "text": "Gleolan®\n (aminolevulinic acid hydrochloride) for oral solution" }

1,500 mg

{ "type": "p", "children": [], "text": "1,500 mg" }

Reconstitute Prior To Use.

{ "type": "p", "children": [], "text": "Reconstitute Prior To Use." }

For Oral Use Only

{ "type": "p", "children": [], "text": "For Oral Use Only" }

SINGLE-DOSE VIAL.

{ "type": "p", "children": [], "text": "SINGLE-DOSE VIAL." }

Discard Unused Portion

{ "type": "p", "children": [], "text": "Discard Unused Portion" }

One Vial

{ "type": "p", "children": [], "text": "One Vial" }

NX Development Corp.

{ "type": "p", "children": [], "text": "NX Development Corp." }