The following Structured Product Label (SPL) was submitted to the FDA by Biofrontera Inc. for the product Ameluz (NDC 70621-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 1. indications and usage, 2.1 important administration information, 2.2 recommended dosage, 2.3 administration instructions, 3. dosage forms and strengths, 4. contraindications, 5.1 hypersensitivity, 5.2 transient amnestic episodes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED® or RhodoLED® XL lamp, a narrowband, red light illumination source, is indicated for:
AMELUZ, in conjunction with lesion preparation, is only to be administered by a healthcare provider.
AMELUZ is for topical use only. Not for ophthalmic, oral, or intravaginal use. Avoid using AMELUZ on the eyelid or around the eye [see Warnings and Precautions (5.4)].
AMELUZ treatment, in combination with photodynamic therapy (PDT), is a multi-stage process that 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.
For treatment of actinic keratoses (AK) of mild-to-moderate severity on the face and scalp: Treat single AK lesions or an entire field affected by multiple AK lesions. Retreat AK lesions that have not completely resolved approximately 3 months after the initial treatment.
Apply an approximately 1 mm thick layer of AMELUZ to skin lesion(s). Cover individual lesions (sBCC or AK) or the entire AK field with AMELUZ. Include approximately 5 mm to 10 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.
AMELUZ treatment, in combination with PDT, is a multi-stage process:
Step 1. Preparation of Lesions
Before applying AMELUZ, carefully wipe all lesions (sBCC or AK) with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin.
Figure 1a: Degreasing Of The Skin (Figure1a)
Thereafter, remove any scaling and crusts and gently roughen all lesion surfaces, taking care to avoid bleeding.
Figure 1b: Figure 1b: Removal Of Scales And Crusts (Figure1b)
Step 2. Application of AMELUZ
Apply AMELUZ using glove protected fingertips or a spatula. Use enough AMELUZ to cover individual lesions (sBCC or AK) or the entire AK 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. AMELUZ 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 at least 10 mm from these areas). In case of accidental contact with mucous membranes, thoroughly rinse with water [see Warnings and Precautions (5.7)].
Allow AMELUZ to dry for approximately 10 minutes before applying occlusive dressing.
Figure 2: Drug Application (Figure2)
Step 3. Occlusion for 3 Hours
Cover the area where AMELUZ 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 (Figure3)
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 the occlusive dressing 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 lesions does not need protection during illumination.
Figure 4a: Illumination With Bf-rhodoled (Figure4a)
Figure 4b: Illumination (3 Panels) (Figure4b 3panel)
Figure 4b: Illumination With Rhodoled Xl (examples With 3 And 5 Panels) (Figure4b)
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.
AMELUZ is contraindicated in patients with:
Several cases of hypersensitivity were reported during postmarketing use of AMELUZ prior to PDT illumination [see Adverse Reactions (6.2)]. If hypersensitivity reactions occur, clean the area of skin where AMELUZ was applied and institute appropriate therapy. Inform patients and their caregivers that AMELUZ may cause hypersensitivity, potentially including severe cases (anaphylaxis).
Transient amnestic episodes have been reported during postmarketing use of AMELUZ in combination with PDT. Inform patients and their caregivers that AMELUZ in combination with PDT 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, vision blurred, visual impairment 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 patients, 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 drugs 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 AMELUZ.
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.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
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.
Adverse Reactions in Subjects with Mild-to-Moderate Actinic Keratosis
The safety and efficacy of AMELUZ in combination with PDT using a narrow spectrum source was evaluated in 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 [see Clinical Studies (14.1)].
For all three 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 Trials 1, 2, and 3.
Application Site Adverse Reaction | AMELUZ | Vehicle |
Erythema Pain/Burning Irritation Edema Pruritus Exfoliation Scab Induration Vesicles Paresthesia Hyperalgesia Reaction Discomfort Erosion Discharge Bleeding Pustules | 195 (92%) 195 (92%) 153 (72%) 75 (35%) 72 (34%) 41 (19%) 41 (19%) 26 (12%) 25 (12%) 18 (9%) 13 (6%) 8 (4%) 7 (3%) 6 (3%) 4 (2%) 3 (1%) 3 (1%) | 34 (39%) 26 (30%) 17 (20%) 3 (3%) 14 (16%) 4 (5%) 2 (2%) 0 (0%) 1 (1%) 2 (2%) 0 (0%) 2 (2%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) |
In Trials 1, 2, and 3, common (≥1%, <10%) adverse reactions not at the application site in AMELUZ-treated subjects were headache, skin exfoliation, chills and eyelid edema.
In Trials 1, 2, and 3, less common (≥0.1%, <1%) application site adverse reactions in AMELUZ-treated subjects were hemorrhage and swelling. Adverse reactions not at the application site were blister, feeling hot, pruritus, pyrexia, scab, nervousness, pain, petechiae, rash pustular, skin erosion and ulcer.
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 in combination with PDT. Most adverse reactions observed were consistent with those reported in trials using one tube (2 g) of AMELUZ on a 20 cm² area (Trials 1, 2, and 3) (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 in 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.
Adverse Reactions in Subjects with Superficial Basal Cell Carcinoma
The safety and efficacy of AMELUZ, in combination with PDT using the BF-RhodoLED lamp, was evaluated in a randomized controlled trial enrolling 187 adults (Trial 4) with superficial basal cell carcinoma (sBCC). Subjects received AMELUZ or vehicle followed by exposure to BF-RhodoLED red light. All subjects were White and the majority had Fitzpatrick skin type I, II, or III [Clinical Studies (14.2)].
Most of the enrolled subjects had one sBCC lesion. Approximately 48% of the lesions were located on the neck and/or trunk and 45% of the lesions were located on the extremities.
All subjects treated with AMELUZ and BF-RhodoLED lamp developed at least one adverse reaction at the application site. The most common adverse reactions during and after AMELUZ treatment in combination with PDT were application site pain that may be severe, erythema, pruritus, edema, paraesthesia, scab, induration, and exfoliation.
Application Site Adverse Reaction | AMELUZ | Vehicle |
Pain Erythema Pruritus Edema Paraesthesia Scab Induration Exfoliation Discoloration Vesicles Dysaesthesia Haemorrhage Dryness Hyperaesthesia Swelling | 138 (95%) 100 (69%) 73 (50%) 42 (29%) 35 (24%) 30 (21%) 25 (17%) 25 (17%) 13 (9%) 12 (8%) 3 (2%) 3 (2%) 2 (1%) 2 (1%) 2 (1%) | 12 (29%) 15 (36%) 11 (26%) 5 (12%) 5 (12%) 2 (5%) 3 (7%) 6 (14%) 1 (2%) 1 (2%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) |
Less common (≥0.1%, <1%) application site adverse reactions were atrophy, hypoesthesia, inflammation, ulcer and fatigue. Less common adverse reactions not at the application site were vision blurred, visual impairment, headache, and solar lentigo.
AMELUZ in combination with PDT was also evaluated in another clinical trial (Trial 5) that included 110 adults with sBCC and safety findings were consistent with those observed in Trial 4.
Sensitization Potential of Aminolevulinic Acid
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 the recommended dose for the treatment of AK or sBCC.
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: dermatitis allergic.
Nervous system disorders: transient amnestic episodes.
Eye disorders: eye irritation, diplopia, ocular hyperemia, photophobia.
Immune System disorders: hypersensitivity.
There have been no formal studies of the interaction of AMELUZ with other drugs. It is possible that concomitant use of other known photosensitizing drugs, 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
The available data on topical aminolevulinic acid use in combination with PDT in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Animal reproduction studies were not conducted with aminolevulinic acid. Systemic absorption of aminolevulinic acid in humans is low 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. All pregnancies have a risk of birth defects, loss, and 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
No data are available regarding the presence of aminolevulinic acid in human milk, or the effects of aminolevulinic acid on the breastfed infant or on milk production. However, breastfeeding is not expected to result in exposure of the infant to the drug due to the low 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 infant from AMELUZ or from the underlying maternal condition.
Safety and effectiveness of AMELUZ have not been established in pediatric patients. AK and sBCC are not conditions generally seen in the pediatric population.
Of the 529 subjects exposed to AMELUZ in randomized, multicenter clinical trials, 72% (382/529) of the subjects were 65 years old and over. No overall differences in safety or effectiveness were observed between these subjects and younger adult 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.
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:
Ala.hcl (Structural Formula)
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 and sBCC 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 is 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.
PK was not assessed in subjects with sBCC.
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, for the treatment of mild-to-moderate AK were evaluated in three randomized, multicenter trials (Trial 1, Trial 2, and Trial 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.
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.
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 3.
AMELUZ | Vehicle | |
Trial 1 | 106/125 (85%) | 5/39 (13%) |
Trial 2 | 27/32 (84%) | 2/16 (13%) |
Trial 3 | 50/55 (91%) | 7/32 (22%) |
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.
The efficacy and safety of AMELUZ, in combination with PDT using the BF-RhodoLED lamp, for the treatment of superficial basal cell carcinoma (sBCC) were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial (Trial 4 [NCT03573401]).
In this trial, 187 subjects with at least 1 histologically confirmed sBCC lesion on the face/forehead, bald scalp, extremities and/or neck/trunk were treated. Most of the enrolled subjects had one sBCC lesion. Approximately 48% of the lesions were located on the neck and/or trunk and 45% of the lesions were located on the extremities. For each subject, one lesion was defined as Main Target Lesion (preselected for surgical excision and histological analysis 12 weeks after start of the last PDT cycle). Additional lesions in the same illumination area were treated but not excised. Subjects ranged from 33 to 89 years of age (mean 63 years), and 95% had Fitzpatrick skin type I, II, or III. No subject had Fitzpatrick skin type V or VI. All subjects were White, with 2% of Hispanic or Latino ethnicity. Approximately 57 % of subjects were male.
All subjects received at least one PDT cycle consisting of two PDTs sessions 7 to 14 days apart. Each session was performed with up to one tube (2 grams) of AMELUZ or vehicle and the BF-RhodoLED lamp. Sessions were comprised of lesion preparation (degreasing with alcohol, and careful debridement to remove scales or crusts), application of AMELUZ or vehicle with occlusion for 3 hours, and removal of the residual gel. Subsequently, the treatment area was illuminated with the BF-RhodoLED lamp at approximately 37 J/cm2.
Subjects clinically diagnosed as partial responders or non-responders 12 weeks after the start of the first PDT cycle received a second PDT cycle (52%, 97/184; 62/145 (42.8%) in the AMELUZ group and 35/42 (83.3%) in the vehicle group).
The primary efficacy endpoint was the composite clinical and histological complete response of the Main Target Lesion 12 weeks after the start of the last PDT cycle. Clinical response was based on clinical assessment only. Histological response was determined by biopsy.
Efficacy results for the primary and key secondary endpoints are presented in Table 4.
AMELUZ | Vehicle | |
Primary Endpoint | ||
Main Target Lesion composite clinical and histological response, n (%) | 95 (66%) | 2 (5%) |
Key Secondary Endpoints: | ||
Main Target Lesion histological response | 110 (76%) | 8 (19%) |
Main Target Lesion clinical response | 121 (83%) | 9 (21%) |
Subject complete clinical response1 | 119 (82%) | 9 (21%) |
Subject complete response2 | 93 (64%) | 2 (5%) |
1 Subject complete clinical response defined as all (main and additional) target lesions assessed as clinically clear 12 weeks after the start of last PDT cycle.
2 Subject complete response defined as main target lesion clinically and histologically clear as well as all additional target lesions assessed as clinically clear 12 weeks after the start of last PDT cycle.
At 12 weeks after start of the last PDT cycle, 26/119 (22%) subjects in the AMELUZ group were clinically cleared at target lesions but had histologically confirmed residual sBCC.
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
NDC 70621-101-10 Cardbox containing one 2 g tube
NDC 70621-101-20 Cardbox containing ten 2 g tubes
Store AMELUZ in a refrigerator, 2°C to 8°C (36°F to 46°F). Excursions permitted to 15°C to 30°C (59°F to 86°F).
After opening, AMELUZ can be stored for up to 12 weeks in a refrigerator at 2°C to 8°C (36°F to 46°F) if the tube is tightly closed.
Inform patients and their caregivers that AMELUZ may cause hypersensitivity, potentially including severe cases (anaphylaxis) [see Warnings and Precautions (5.1)].
Inform patients that 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 following treatment with AMELUZ, avoid exposure to sunlight, and prolonged or intense light on the treated lesion sites and surrounding skin for approximately 48 hours.
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 sensations of burning and pain that may be severe commonly occur during and after treatment with AMELUZ in combination with PDT. Advise patients to contact the healthcare provider if symptoms are severe [see Adverse Reactions (6.1)].
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 Adverse Reactions (6.1)].
AMELUZ, BF-RhodoLED and RhodoLED are registered trade marks of Biofrontera Inc.
PATENT INFO
Patent 11,540,981
Distributed by:
Biofrontera Inc.
660 Main Street
1st Floor
Woburn, MA 01801
USA
Cover 01 (Um Cover) 
User Manual
Manufacturer: Biofrontera Discovery GmbH
Distributor: Biofrontera Inc.
Foreword
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 (USPI). The Ameluz® prescribing information includes information on how to use the gel along with contraindications, warnings and precautions, and dosage and administration.
The product labels/ markings shown in this manual are examples. They may differ slightly from those on the lamp.
This manual is valid for BF-RhodoLED® lamps manufactured by Biofrontera Pharma GmbH or Biofrontera Discovery GmbH.
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.
For further questions about Ameluz®, BF-RhodoLED®, or the combination therapy, please contact your sales representative or Biofrontera ([email protected]). See contact information below or visit us at http://www.biofrontera.us.com/
Sales representative: Name: Tel.: E-mail: | Biofrontera Inc. 660 Main Street |
Warranty and Disclaimers
Please see the terms and conditions of your contract for this information.
Manufacturer
Biofrontera Discovery GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany
"AMELUZ, RHODOLED and BF-RhodoLED are registered trademarks of Biofrontera Inc.
©2026 Biofrontera Inc. All rights reserved.”
1 Intended Use
BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® gel for the treatment of:
2 BF-RhodoLED® - General Description
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
 Symbol 01 (Um Symbol 01) | The BF-RhodoLED® 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. |
| Symbol 01 (Um Symbol 01) | 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® USPI section 6. |
 Symbol 02 (Um Symbol 02) | The user manual must be read carefully prior to using the BF-RhodoLED®. |
| Symbol 01 (Um Symbol 01) | The BF-RhodoLED® may only be used by healthcare professionals who have received adequate training in its use. |
 Symbol 03 (Um Symbol 03) | 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. |
| Symbol 01 (Um Symbol 01) | Neither the BF-RhodoLED® 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. |
 Symbol 04 (Um Symbol 04) | Risk of trapping fingers! The mobility of the adjustable scissor arm may be obstructed by objects placed in or near slots! 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 NOT placed in or near the slots (see Figure 1). |
| Symbol 01 (Um Symbol 01) | Beware of Tipping! 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. Do not place the lamp on uneven or unstable surfaces. 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. |
| Symbol 01 (Um Symbol 01) | In order to avoid the risk of electrical shock, the device may only be connected to a power supply with a grounded connection. |
| Symbol 01 (Um Symbol 01) | Neither the BF-RhodoLED® 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). |
 Symbol 05 (Um Symbol 05) | 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). |
| Symbol 05 (Um Symbol 05) | 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. |
| Symbol 05 (Um Symbol 05) | The BF-RhodoLED® 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 %. |
| Symbol 05 (Um Symbol 05) | 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. |
| Symbol 05 (Um Symbol 05) | 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. |
| Symbol 05 (Um Symbol 05) | 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. |
| Symbol 05 (Um Symbol 05) | The touchscreen monitor should not be exposed to strong external pressure or sharp objects. |
| Symbol 05 (Um Symbol 05) | A person trained in operation of the BF-RhodoLED® must always be present during treatment. |
| Symbol 05 (Um Symbol 05) | The device must be protected against unauthorized use. |
| Both the maintenance and the assembly of the BF-RhodoLED® 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. |
Figure 01 (Um Figure 01)
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).
4 BF-RhodoLED® Technical Description
4.1 Light Emitting Diodes (LEDs)
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 02 (Um Figure 02)
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)
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:
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
The BF-RhodoLED® LED lamp consists of the following components (Figure 3):
Figure 03 (Um Figure 03)
Figure 3: BF-RhodoLED® main components. (The appearance of devices from batches 001 to 003 slightly differs.)
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
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.
| Symbol 03 (Um Symbol 03) | 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. |
6 BF-RhodoLED® PDT Summarized Step-by-Step Instructions
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.
| STEP 1) | Plug in lamp. |
| STEP 2) | Turn on the lamp and wait for home screen to appear (see chapter 7.3) |
| STEP 3) | Check the proper functioning of the BF-RhodoLED®. |
| STEP 4) | Treat the affected skin area: Application, incubation and removal of the topical medication following the USPI of Ameluz®. |
| STEP 5) | Position patient comfortably and place protective eyewear on patient (see chapter 5). |
| STEP 6) | Position the lamp and adjust the lamp head over the skin area to be treated (distance 5-8 cm) (see chapter 7.5.1). |
| STEP 7) | Put on protective eyewear and make sure anyone remaining in the treatment room also wears protective eyewear (see chapter 5). |
| STEP 8) | 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). Remind the patient to remain still throughout the illumination period. If sound tone during treatment is activated, explain the beep sequence to the patient. 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). To abort the illumination, press "Stop" on the profile standard screen. Adjust fan speed as needed by patient by pressing plus or minus 1% or 10% on the profile standard screen. Stay with the patient at all times during the illumination period. |
| STEP 9) | At the end of the illumination period, remove patient's protective eyewear and follow further instructions in the Ameluz® USPI. |
7 Detailed Operating Instructions
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.
| Symbol 03 (Um Symbol 03) | 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. |
7.1 Transport of the lamp
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 04 (Um Figure 04)
Figure 4: Transport of the lamp. (The appearance of devices from batches 001 to 003 slightly differs.)
7.2 Movement area of the scissor arm and the lamp head
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 05 (Um Figure 05)
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.)
7.3 Turning the Lamp On or Off
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.
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
Icon 02 (Um Icon 02)
Figure 06 (Um Figure 06)
Figure 6: Touchscreen monitor
Note: The blue LED of the push button indicates that the device is in stand-by mode.
7.4 Touchscreen Monitor and Menu
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
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 07 (Um Figure 07)
Figure 7: Start screen
7.4.2 Home Screen
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
Icon 02 (Um Icon 02)
Figure 08 (Um Figure 08)
Figure 8: Home screen
7.5 Conducting a Treatment
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
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 09a (Um Figure 09a)
Figure 09b (Um Figure 09b)
Figure 9: Positioning of the lamp head to the treated skin area
7.5.2 Adjustment Light
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 (Um Figure 10)
Figure 10: Treatment menu
Figure 11 (Um Figure 11)
Figure 11: Start and Stop adjustment
7.5.3 Treatment Menu
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 (Um Figure 12)
Figure 12: Treatment menu
In the treatment menu (Figure 12), press the "Start" button to access the profile standard screen.
7.5.4 Profile Standard Menu
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.
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.
Figure 13 (Um Figure 13)
Figure 13: Profile standard
7.5.5 Audio Signals during Treatment
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
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
The settings menu is invoked (Figure 14) by pressing the "Settings" button in the home screen view (see Figure 12).
Figure 14 (Um Figure 14)
Figure 14: Settings menu
You can configure the following parameters in this menu:
Switch back to the home screen menu via the "Back" button.
7.6.1 Language Settings
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 (Um Figure 15)
Figure 15: Language setting
7.6.2 Sound Settings
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.
Figure 18 (Um Figure 18)
Figure 16: Sound setting
7.6.3 Energy Service (Power Management)
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 19 (Um Figure 19)
Figure 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.
7.7 Service Menu
Authorization is required to access the service menu. Only authorized personnel can access the service menu.
8 Error Messages
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.
| Error message | Possible causes | Measures |
| Lamp overheated! |
| Wait until the standard temperature has been reached. Check the ventilator and test the air inlets and outlets. Remove any visible foreign objects which may be present. In case of continuing impairment of cooling please contact your local sales representative or Biofrontera. |
| Lamp error! Please inform your supplier. |
| Further treatments may be carried out. However, please contact your local sales representative or Biofrontera immediately. |
| Communication error! |
| Confirm the communication error. Treatments can be continued in the treatment menu by pressing the "Start" button. Please contact your local sales representative or Biofrontera. |
| Lamp not calibrated! |
| The lamp has to be calibrated. Please contact your local sales representative or Biofrontera immediately. |
| Fehler-Nr.: 0084 Please inform your supplier. |
| The lamp head has to be repaired. Please contact your local sales representative or Biofrontera. |
| Firmware of light head is faulty or missing! Please inform your supplier. |
| An update of the firmware has to be performed. Please contact your local sales representative or Biofrontera. |
If your LED lamp no longer functions properly for some unknown reason, proceed as follows:
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.
9 Servicing
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.
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.
Contact your sales representative or Biofrontera to schedule all service appointments.
10 Maintenance and Cleaning
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:
| Daily: | Wipe the plexiglass screen located on the bottom of the lamp head with a damp soft cloth (e. g. a microfiber cloth). |
| Weekly: | 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 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®. A known exception is the agent "Incidin PlusTM" (active ingredient: Glucoprotamine) which can cause corrosion of the lamp head surfaces.
|
| Please observe the following checks: | |
| Monthly: | 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. |
11 Disposal Instructions
Follow all local and governmental disposal laws and regulations when disposing of the BF-RhodoLED®.
12 Technical Data
12.1 Electrical connectors
Power supply unit:
Mother board for voltage management and control:
LED board:
Human Machine Interface (HMI) for operation:
12.2 Specification
| Type | BF-RhodoLED® Medical device class III; Device of protection class 1 |
| Certification | UL certified |
| Manual is valid for Software Version No. | 1.6_US_CAN or lower (for your current software version, see start screen 7.4.1) |
| Service life of the lamp | Approx. 4 years |
| Shelf life | 1.5 years |
| Number of LEDs | 128 |
| Typical peak wavelength | 635 nm ± 5 nm |
| Light dose (6 cm distance, 10 min) | Approx. 37 J/ cm2 |
| Typical irradiance | 61 mW/cm2 +/- 15 % |
| Max irradiance | 77 mW/cm2 +/- 15 % (at 5 cm treatment distance) |
| Illuminated area | 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). |
| Max. deviation of the intensity over the treatment area | Approx. 15 % |
| Transport and storage conditions | Temperature: -30°C to +60°C (-22°F to +140°F) Atmospheric pressure: 500 hPa - 1060 hPa |
| Operating conditions | Temperature: 0°C to +40°C (32°F to +104°F) Atmospheric pressure: 700 hPa - 1060 hPa |
| Operating voltage | 120-240 VAC, 50/60 Hz |
| Output voltage | 48 VDC |
| Power consumption | In calibrated normal operation: approx. 140 VA In standby mode: approx. 85 VA |
| Over-voltage category | II |
| Degree of contamination | 2 |
| Material group (CTI) | IIIb |
| Protection class | IP20 |
| Size of the lamp | 95 x 62 x 168 cm (37 x 24 x 66 inches) Devices of batch 001 to 003: 127 x 56 x 168 cm (50 x 22 x 66 inches) |
| Total lamp weight | Approx. 52 kg (115 lbs) Devices of batch 001 to 003: approx. 48 kg (106 lbs) |
For further information please directly contact Biofrontera.
13 Labeling and Symbols
13.1 Labeling on the Lamp
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. It also includes a Unique Device Identifier (UDI) DataMatrix containing device identification (01), serial number (21), and manufacturing date (11).
Figure 20 (Um Figure 20)
Figure 18: Product labels — the serial number, manufacturing date, and UDI DataMatrix are variable.
Labels with safety instructions, special disposal instructions and further instructions are represented in the following figures.
Figure 21 (Um Figure 21)
Figure 19: Instructions and notes on the lamp head
Figure 22 (Um Figure 22)
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.)
Figure 23 (Um Figure 23)
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.)
Instructions for existing ground connector connections (see Figure 22) are located:
Figure 24 (Um Figure 24)
Figure 22: Instructions for ground connector connection
Figure 25 (Um Figure 25)
Figure 23: BF-RhodoLED®. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)
Instructions on the existing potential compensator conductor is located on the carrier bar beneath the potential compensator conductor (see Figure 24).
Figure 26 (Um Figure 26)
Figure 24: Potential compensator conductor. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)
All depicted symbols are summarized in a table in section 13.2 "Explanation of symbols".
13.2 Description of Symbols
| Symbol | Description |
| Symbol 03 (Um Symbol 03) | Eye protection is required. |
| IP20 | IP (Ingress Protection): Protection class of the housing against contact, foreign bodies and water 2 = against ingress of solid foreign bodies ≥ 12.5 mm Ø and larger 0 = Not protected against water |
 Symbol 06 (Um Symbol 06) | 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. |
 Symbol 07 (Um Symbol 07) | Symbol for existing ground connector connections |
| Symbol 02 (Um Symbol 02) | Follow the instructions for use! |
| Symbol 01 (Um Symbol 01) | General warning signs:
|
| Symbol 04 (Um Symbol 04) | Warning sign - risk of trapping fingers! |
 Symbol 08 (Um Symbol 08) | Symbol for existing potential compensation conductor Function/Application: 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. Please observe the requirements for ME-systems set out in EN 60601-1 when using the potential compensation cable (chapter 16). |
 Symbol 09 (Um Symbol 09) | Please do not stand on or push. There is a risk that the device may fall over due to the force applied. |
 Symbol 10 (Um Symbol 10) | Please do not sit on the equipment. There is a risk that the device may fall over due to the force applied. |
13.3 Labeling on the Packaging
Symbol 11 (Um Symbol 11)
Symbol 12 (Um Symbol 12)
Symbol 13 (Um Symbol 13)
Symbol 14 (Um Symbol 14)
14 Electromagnetic compatibility (EMC)
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.
| Guidelines and manufacturer's declaration - electromagnetic emissions |
BF-RhodoLED® 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. |
| Emission readings | Conformity | Electromagnetic environment - guidelines |
| HF emissions CISPR 11 | Group 1 | BF-RhodoLED® only uses HF energy for its internal functionality. For this reason, its HF emission is very low and it is not likely that neighbouring electronic devices would be disturbed. |
HF emissions in accordance with CISPR 11 Harmonics in accordance with IEC 61000-3-2 Voltage fluctuations/flickers in accordance with IEC 61000 3-3 | Class B Class A In compliance | BF-RhodoLED® is intended for operation in non-residential facilities and similar environments that are connected directly to a public low-voltage supply network that also supplies residential buildings. |
| Guidelines and manufacturer's declaration - electromagnetic immunity |
BF-RhodoLED® 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. |
| Immunity tests | IEC 60601 test levels | Compliance level | Electromagnetic environment - guidelines |
| Static discharge in accordance with IEC 61000-4-2 | ±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge | ±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge | 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 %. |
| Fast, transient electrical disturbances/bursts in accordance with IEC 61000-4-4 | ±2 kV for mains lines ±1 kV for input and output lines | ±2 kV for mains lines | The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. |
| Surges in accordance with IEC 61000-4-5 | ±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth | ±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth | The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. |
| Voltage drops, brief interruptions and fluctuations in the supply voltage in accordance with IEC 61000-4-11 | 0 % UT 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) 0 % UT for 1 cycle 70 % UT for 25/30 cycles 0 % UT for 250/300 cycles | 0 % UT 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) 0 % UT for 1 cycle 70 % UT for 25/30 cycles 0 % UT for 250/300 cycles | The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. 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. |
| Power frequency (50/60 Hz) magnetic field in accordance with IEC 61000-4-8 | 3 A/m | 3 A/m | Mains frequency magnetic fields should correspond to the values typically found in the commercial and hospital environment. |
Comment: UT is the mains AC voltage prior to application of the test level |
| Guidelines and manufacturer's declaration - electromagnetic immunity |
| BF-RhodoLED® 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. |
| Immunity tests | IEC 60601 test levels | Compliance level | Electromagnetic environment - guidelines |
Conducted HF disturbances in accordance with IEC 61000-4-6 Radiated HF disturbances in accordance with IEC 61000-4-3 | 3 V 6 V 3 V/m 80 MHz to 2.7 GHz | 3 V 6 V 3 V/m | Portable and mobile communication devices should not be used in closer proximity to the unit or its cables than the recommended safety distance of 300 mm. Interference may occur in the vicinity of equipment marked with the following symbol.  Symbol 05 (Um Xl Symbol 05) |
| 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. |
Recommended safety distances between portable and mobile HF telecommunication devices and the BF-RhodoLED® |
The BF-RhodoLED® is intended for use in the electromagnetic environment in which the HF disturbances are controlled.
BF-RhodoLED® should not be used directly alongside or between other electrical equipment. |
| Guidelines and manufacturer's declaration - proximity fields from RF wireless communication equipment |
BF-RhodoLED® 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. |
| Service | Frequency range/ discrete frequencies MHz | Compliance level [V/m] |
| TETRA 400 | 390 | 27 |
| GMRS 460, FRS 460 | 430 | 28 |
| LTE Band 13, 17 | 734 746 788 | 9 |
| GSM 800/900, TETRA 800, iDEN 820, CDMA, LTE Band 5 | 821 862 948 | 28 |
| GSM 1800, CDMA 1900, GSM 1900,DECT, LTE Band 1,3,4, 25 | 1730 1825 1970 | 28 |
| Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 | 2452 | 28 |
| WLAN 802.11 a/n | 5240 5500 5700 | 9 |
Version 2.0
Figure 00 (Um Xl Cover)
User Manual
Manufacturer: Biofrontera Discovery GmbH
Distributor: Biofrontera Inc.
Foreword
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 (USPI). The Ameluz® prescribing information includes information on how to use the gel along with contraindications, warnings and precautions, and dosage and administration.
The product labels/ markings shown in this manual are examples. They may differ slightly from those on the lamp.
Thorough reading and use of both this user manual and the Ameluz® USPI is required prior to treatment.
Our combination Ameluz®/RhodoLED® XL for photodynamic therapy is only to be used by physicians or healthcare professionals.
For further questions about Ameluz®, RhodoLED® XL, or the combination therapy, please contact your sales representative or Biofrontera ([email protected]). See contact information below or visit us at http://www.biofrontera.us.com/
Sales representative: Name: Tel.: E-mail: | Biofrontera Inc. 660 Main Street |
Warranty and Disclaimers
Please see the terms and conditions of your contract for this information.
Manufacturer
Biofrontera Discovery GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany
"AMELUZ and RHODOLED are registered trademarks of Biofrontera Inc. ©2026 Biofrontera Inc. All rights reserved.”
1 Intended Use
RhodoLED® XL is a red light-emitting LED lamp, which is used exclusively in combination with Ameluz® gel for the treatment of:
2 RhodoLED® XL - General Description
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
 Symbol 08 (Um Xl Symbol 08) | The RhodoLED® XL has been developed for use in photodynamic therapy in combination with Ameluz® gel (excitation wavelength 635 nm). Any other use or combination of use is prohibited. |
| Symbol 08 (Um Xl Symbol 08) | 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® USPI section 6. |
 Symbol 13 (Um Xl Symbol 13) | The user manual must be read carefully prior to using the RhodoLED® XL. |
| Symbol 08 (Um Xl Symbol 08) | The RhodoLED® XL may only be used by healthcare professionals who have received adequate training in its use. |
 Symbol 02 (Um Xl Symbol 02) | Bright light, do not stare into the light source |
 Symbol 06 (Um Xl Symbol 06) | Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006. |
 Symbol 10 (Um Xl Symbol 10) |  Symbol 11 (Um Xl Symbol 11) Distance sensor of RhodoLED® 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. |
 Symbol 07 (Um Xl Symbol 07) | Risk of trapping fingers! Depending on positioning, fingers can be trapped between LED panels, between LED panels and the holding bracket, between the movable part and the fixed part of the lamp head holding bracket. |
| Symbol 08 (Um Xl Symbol 08) | Neither the RhodoLED® 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. |
| Symbol 08 (Um Xl Symbol 08) | In order to avoid the risk of electrical shock, the device may only be connected to a power supply with a grounded connection. |
| Symbol 08 (Um Xl Symbol 08) | Neither the RhodoLED® 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). |
 Symbol 12 (Um Xl Symbol 12) | The RhodoLED® 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 %. |
| Symbol 12 (Um Xl Symbol 12) | 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. |
| Symbol 12 (Um Xl Symbol 12) | 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. |
| Symbol 12 (Um Xl Symbol 12) | Ensure that the control unit is always returned to parking position to avoid damage during transport. |
| Symbol 12 (Um Xl Symbol 12) | The control unit should not be exposed to strong external pressure or sharp objects. |
| Symbol 12 (Um Xl Symbol 12) | A person trained in operation of the RhodoLED® XL must always be present during treatment. |
| Symbol 12 (Um Xl Symbol 12) | Before treating affected skin area with the topical medication check the proper functioning of the RhodoLED® XL. Do not use a damaged device for treatment. |
| Symbol 12 (Um Xl Symbol 12) | RhodoLED® XL is intended for operation in non-residential facilities and similar environments that are connected directly to a public low-voltage supply network that also supplies residential buildings. RhodoLED® 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 |
| Symbol 12 (Um Xl Symbol 12) | 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. |
| Symbol 12 (Um Xl Symbol 12) | 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. |
| Symbol 12 (Um Xl Symbol 12) | The device must be protected against unauthorized use. |
| Maintenance and initial set up of the RhodoLED® 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. |
4 RhodoLED® XL Technical Description
4.1 Light emitting diodes (LED)
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 01 (Um Xl Figure 01)
Figure 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:
- Illumination time of 10 minutes
- Treatment distance of 4.9 ± 0.6 inches (12.5 cm ± 1.5 cm)
The illumination area of the LED lamp is 9.06 x 11.42 inches (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.
4.2 RhodoLED® XL Components
The RhodoLED® XL consists of the following main components (Figure 2):
Figure 02 (Um Xl Figure 02) 
Figure 2: RhodoLED® XL main components
5 Operating environment of RhodoLED® XL
RhodoLED® XL shall be operated in environments of professional health care facilities. For a detailed description of electromagnetic compatibility see chapter 15. RhodoLED® XL is intended for operation in non-residential facilities and similar environments that are connected directly to a public low-voltage supply network that also supplies residential buildings.
6 Eye Protection
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.
| Symbol 06 (Um Xl Symbol 06) | Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006. |
7 RhodoLED® XL PDT Summarized Step-by-Step Instruction
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.
| STEP 1) | Plug in the lamp. |
| STEP 2) | Turn on the lamp and wait for the home screen to appear (see chapter 8.4.3). |
| STEP 3) | Check the proper functioning of the RhodoLED® XL. |
| STEP 4) | Treat the affected skin area: Application, incubation, and removal of the topical medication according to the USPI of Ameluz®. |
| STEP 5) | Position the patient comfortably and equip the patient with protective eyewear (see chapter 6). |
| STEP 6) | Select active panels (see chapter 8.4.5). |
| STEP 7) | Position the lamp and adjust the lamp head over the skin area to be treated (distance 4.9 inches /12.5 cm) (see chapter 8.4.6). |
| STEP 8) | Put on protective eyewear and make sure anyone remaining in the treatment room also wears protective eyewear (see chapter 6). |
| STEP 9) | Start treatment by pressing Start, the illumination period begins (see chapter 8.4.9). Remind the patient to remain still throughout the illumination period. If audible indicators during treatment are activated, explain the sounds to the patient. If the patient needs a break, press Pause on the screen. To resume treatment, press Resume (see chapter 8.4.10). To abort the illumination, press Cancel (see chapter 8.4.10). Always stay with the patient during the illumination period. |
| STEP 10) | At the end of the illumination period, remove patient's protective eyewear and follow further instructions in the Ameluz® USPI. |
8 Detailed Operating Instructions
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.
| Symbol 06 (Um Xl Symbol 06) | Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006. |
8.1 Transport of RhodoLED® XL and Spring Arm Lock Function
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).
Figure 03 (Um Xl Figure 03)
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.
8.2 Movement Areas
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°.
Figure 04 (Um Xl Figure 04)
Figure 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).
Figure 05 (Um Xl Figure 05)
Figure 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.
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.
Figure 06 (Um Xl Figure 06)
Figure 6: Control unit positions
8.3 Turning RhodoLED® XL On and Off
Note: Before turning on the lamp, the power cord must be plugged into a power outlet. RhodoLED® XL is intended for operation in non-residential facilities and similar environments 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 power supply 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.
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.
Figure 07 (Um Xl Figure 07)
Figure 7: Control unit of RhodoLED® XL with power button
8.4 RhodoLED® XL Controls
8.4.1 Control Unit
The touchscreen of the control unit can be used while wearing commercially available examination gloves.
8.4.2 Splash Screen
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 08 (Um Xl Figure 08)
Figure 8: Splash screen
8.4.3 Home Screen
The home screen appears after the operating system has loaded.
Figure 09 (Um Xl Figure 09)
Figure 9: Home screen
8.4.4 The Treatment Profile
The RhodoLED® XL has a fixed LED light intensity which ensures the application of 37 J/cm² within the 10-minute treatment time.
8.4.5 Selecting Active LED Panels
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 (Um Xl Figure 10)
Figure 10: Software illustration of RhodoLED® XL LED panels (all panels are activated)
Figure 11 (Um Xl Figure 11)
Figure 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.
Figure 12 (Um Xl Figure 12)
8.4.6 Treatment Area
The illumination area of RhodoLED® XL is 9.06 x 11.42 inches (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.
Figure 13 (Um Xl Figure 13)
Figure 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 one outer panel to the midline of the other outer panel.
If 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
The correct treatment distance for the RhodoLED® XL is 4.9 ± 0.6 inches (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).
Table 1: Adjusting the treatment distance
| Pictogram | Meaning |
 Symbol 03 (Um Xl Symbol 03) | Treatment distance is correct for this LED panel (4.9 ± 0.6 inches / 12.5 ± 1.5 cm), adjustment light is/turns on |
 Symbol 01 (Um Xl Symbol 01) | Treatment distance is too small for this LED panel. LED panel must be further away from treatment area, adjustment light is/turns off |
 Symbol 04 (Um Xl Symbol 04) | Treatment distance is too large for this LED panel. LED panel must be closer to the treatment area, adjustment light is/turns off |
 Symbol 15 (Um Xl Symbol 15) | This LED panel is switched off |
8.4.8 Adjustment Light
If the correct treatment distance of 4.9 inches (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 inches (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).
Figure 14 (Um Xl Figure 14)
Figure 14: Low light intensity for correct adjustment of LED panels.
8.4.9 Starting an Illumination
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).
| Symbol 06 (Um Xl Symbol 06) | Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006. |
Figure 15 (Um Xl Figure 15)
Figure 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).
Figure 16 (Um Xl Figure 16)
Figure 16: Treatment progress.
8.4.10 Pause, continue, or cancel a treatment
Figure 17 (Um Xl Figure 17)
Figure 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).
Figure 18 (Um Xl Figure 18)
Figure 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.
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
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).
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.
8.5 Settings Menu
 Symbol 17 (Um Xl Symbol 17) | To open the settings menu, select the gear symbol in the upper right corner of the screen. |
The settings menu is organized in the tabs General, Service and Info.
Figure 19 (Um Xl Figure 19)
Figure 19: The settings menu is organized in the three main tabs General, Service and Info
8.5.1 Language
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.
8.5.2 Distance Units
Unit settings are part of the General settings tab. The distance of the LED panels to the treatment area can be displayed in inches 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.
8.5.3 Auto power off
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.
8.5.4 Sound Settings
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.
Note: The audio signals are very low in volume and may not be audible to the patient during operation.
Note: Warning sounds will be emitted if an error occurs during operation of the lamp. Warning sounds cannot be turned off.
8.5.5 Info-Tab
The system status provides information about the current hardware and software status of the device.
This includes information about:
• 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.
8.5.6 Service Menu
 Symbol 16 (Um Xl Symbol 16) | Authorization is required to access the service menu. Only authorized personnel can access the service menu. See also chapter 10. |
9 Error Messages
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.
| Error code | Possible causes | Measures |
| 001 System error | Error in system of the device | - Confirm the system error - Please contact your local sales representative or Biofrontera |
| 002 Communication error | Communication between the control unit and the LED panels disturbed | - Confirm the communication error - Treatment can be continued by confirming the message dialog - Please contact your local sales representative or Biofrontera - If there is a permanent error in the communication, no further treatment is possible |
003 Panel error  Symbol 14 (Um Xl Symbol 14) | Error in the control of one or more LED panel Defective LED panels are marked with a red triangle | - Confirm the Panel error - Treatment can be continued by confirming the message dialog - Please contact your local sales representative or Biofrontera |
| 004 Distance sensor error | Error in control of the distance sensors | - Confirm the Distance sensor error - Treatment can be continued by confirming the message dialog - Please contact your local sales representative or Biofrontera |
| 005 Update process error | The software needs updating | - Please contact your local sales representative or Biofrontera |
| 006 Temperature sensor error | Defective temperature sensor or defect in temperature sensor control | - Confirm the Temperature sensor error - Treatment can be continued by confirming the message dialog - Please contact your local sales representative or Biofrontera |
| 007 Cooling system error | The ventilators or ventilator slots are blocked The air inlets or outlets are adversely affected | - Check the ventilators and test the air inlets and outlets - Remove any visible foreign objects which may be present |
| The treatment is paused due to an overheated LED panel. Wait until normal temperature is reached. | The temperature is too high | - Wait until the standard temperature has been reached - Treatment can then be resumed |
If your RhodoLED® XL no longer functions properly for some unknown reason, proceed as follows:
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.
Please have the system status (chapter 8.5.5) available if you contact your sales representative or Biofrontera.
10 Servicing and repairs
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.
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.
Figure 20 (Um Xl Figure 20)
Figure 20: Servicing and maintenance may only be performed by Biofrontera
11 Maintenance and Cleaning
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, as 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:
| Daily: | Wipe the plexiglass screen located on the bottom of the lamp head with a damp soft cloth (e.g., a microfiber cloth). |
| Weekly: | 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, Multi-Purpose Cleaners (Clorox Healthcare VersaSure Wipes) or pre-soaked disinfection wipes based on quaternary ammonium compounds (e.g. Cavi wipes XL or Clorox disinfection wipes). |
| Please observe the following checks: | |
| Monthly: | 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. |
12 Disposal Instructions
Follow all local and governmental disposal laws and regulations when disposing of the RhodoLED® XL.
13 Technical Data
13.1 Electrical Connectors
Power supply unit:
LED controller board:
LED board:
Human Machine Interface (HMI) for operation:
13.2 Specification
| Type | RhodoLED® XL Medical device class III; Device of protection class 1 |
| Certification | UL certified E513735 |
| Manual is valid for Software Version No. | g2.15.00.3911 |
| Service interval | Biofrontera recommends performing service every 2 years |
| Number of LEDs | 225 |
| Typical peak wavelength | 635 nm ± 5 nm |
| Light dose | Approx. 37 J/ cm2 at 4.9 inches (12.5 cm) distance, 10 min |
| Typical irradiance | approx. 60 mW/cm² ± 20 % at 4.9 inches (12.5 cm) distance |
| Max irradiance | approx. 72 mW/cm² at 4.9 inches (12.5 cm) distance |
| Illuminated area | An area of 9.06 x 11.42 inches (23 cm x 29 cm) is illuminated using all panels in curved shape. |
| Max. deviation of the intensity over the treatment area | Approx. 20 % |
| Treatment distance | 4.9 ± 0.6 inches (12.5 cm ± 1.5 cm) |
| Transport conditions | Temperature: -4°F to +140°F (-20°C to +60°C) |
| Storage conditions | Temperature: +59°F to +95°F (+ 15°C to +35°C) |
| Operating conditions | Temperature: +59°F to +86°F (+15°C to + 30°C) |
| Operating voltage | 100-120 VAC, 60 Hz |
| Output voltage | 48 VDC |
| Power consumption | In normal operation: approx. 750 VA |
| Over-voltage category | II |
| Degree of contamination | 2 |
| Material group (CTI) | IIIb |
| Protection class | IP20 |
| Size of the lamp | Height 5.76 ft (175.5 cm) Width: 2.51 ft (76.4 cm) Depth: 3.19 ft (97.1 cm) |
| Total lamp weight | 165 lb. (75 kg) |
For further information please directly contact Biofrontera.
14 Labeling and Symbols
14.1 Label on the Lamp Base
Figure 21 (Um Xl Figure 21)
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.
Figure 22 (Um Xl Figure 22)
Figure 22: No stepping on the device, no disposal in household waste, information on setup and service.
Figure 23 (Um Xl Figure 23)
Figure 23: Instruction for ground connector connection (not visible from the outside)
14.2 Label on LED Panels
Figure 24 (Um Xl Figure 24)
Figure 24: Instruction and notes on the LED panels
Figure 25 (Um Xl Figure 25)
Figure 25: LED Panel numbering from Panel 1 to Panel 5
14.3 Description of Symbols
| Symbol | Description |
| Symbol 06 (Um Xl Symbol 06) | Eye protection is required. |
| Symbol 11 (Um Xl Symbol 11) Symbol 10 (Um Xl Symbol 10) | Distance sensor of RhodoLED® XL is a class 1 laser product. A class 1 laser product is safe under all conditions of normal use. |
| IP20 | IP (Ingress Protection): Protection class of the housing against contact, foreign bodies and water 2 = against ingress of solid foreign bodies ≥ 12.5 mm Ø and larger 0 = Not protected against water |
 Symbol 19 (Um Xl Symbol 19) | 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. |
 Symbol 09 (Um Xl Symbol 09) | Symbol for existing ground connector connections |
| Symbol 13 (Um Xl Symbol 13) | Follow the instructions for use! |
| Symbol 08 (Um Xl Symbol 08) | General warning signs:
|
| Symbol 07 (Um Xl Symbol 07) | Warning sign - risk of trapping fingers! |
| Symbol 02 (Um Xl Symbol 02) | Bright light, do not stare into the light source |
 Symbol 18 (Um Xl Symbol 18) | Do not step on the device. |
15 Electromagnetic compatibility
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.
| Guidelines and manufacturer's declaration - electromagnetic emissions | ||
RhodoLED® 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.
| ||
| Emission readings | Conformity | Electromagnetic environment - guidelines |
| HF emissions CISPR 11 | Group 1 | RhodoLED® 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. |
| HF emissions in accordance with CISPR 11 | Class A | RhodoLED® XL is intended for operation in non-residential facilities and similar environments that are connected directly to a public low-voltage supply network that also supplies residential buildings. |
| Harmonics in accordance with IEC 61000-3-2 | Class A | |
| Voltage fluctuations/flickers in accordance with IEC 61000-3-3 | In compliance | |
| Guidelines and manufacturer's declaration - electromagnetic immunity | |||
| RhodoLED® 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. | |||
| Immunity tests | IEC 60601 test levels | Compliance level | Electromagnetic environment - guidelines |
| Static discharge in accordance with IEC 61000-4-2 | ±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge | ±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge | 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%. |
| Fast, transient electrical disturbances/bursts in accordance with IEC 61000-4-4 | ±2 kV for mains lines 100 kHz repetition frequency | ±2 kV for mains lines | The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. |
| Surges in accordance with IEC 61000-4-5 | ±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth | ±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth | The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. |
| Voltage dips, brief interruptions and fluctuations in the supply voltage in accordance with IEC 61000-4-11 | 0 % UT 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) 0 % UT for 1 cycle 70 % UT for 25/30 cycles 0 % UT for 250/300 cycles | 0 % UT 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) 0 % UT for 1 cycle 70 % UT for 25/30 cycles 0 % UT for 250/300 cycles | The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. 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. |
| Power frequency (50/60 Hz) magnetic field in accordance with IEC 61000-4-8 | 30 A/m | 30 A/m | Mains frequency magnetic fields should correspond to the values typically found in the commercial and hospital environment. |
| Comment: UT is the mains AC voltage prior to application of the test level | |||
| Guidelines and manufacturer's declaration - electromagnetic immunity | |||
| RhodoLED® 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. | |||
| Immunity tests | IEC 60601 test levels | Compliance level | Electromagnetic environment - guidelines |
Conducted HF disturbances in accordance with IEC 61000-4-6 | 3 V 150 kHz to 80 MHz 6 V | 3 V 6 V | 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. |
Radiated HF disturbances in accordance with IEC 61000-4-3 | 3 V/m 80 MHz to 2.7 GHz 80 % AM with 1 kHz | 3 V/m | Interference may occur in the vicinity of equipment marked with the following symbol. Symbol 05 (Um Xl Symbol 05) |
| 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. | |||
| Recommended safety distances between portable and mobile HF telecommunication devices and the RhodoLED® XL. |
| 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 RhodoLED® XL. Failure to do so may result in a reduction in the performance of the device. RhodoLED® XL should not be used directly alongside or between other electrical equipment. |
| Guidelines and manufacturer’s declaration – proximity fields from RF wireless communication equipment | ||
| RhodoLED® 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. | ||
| Service | Frequency range/ discrete frequencies MHz | Compliance level [V/m] |
| TETRA 400 | 385 | 27 |
| GMRS 460, FRS 460 | 450 | 29 |
| LTE Band 13, 17 | 710 745 780 | 9 |
| GSM 800/900, TETRA 800, iDEN 820, CDMA, LTE Band 5 | 810 870 930 | 28 |
| GSM 1800, CDMA 1900, GSM 1900,DECT, LTE Band 1,3,4, 25 | 1720 1845 1970 | 28 |
| Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 | 2450 | 28 |
| WLAN 802.11 a/n | 5240 5500 5785 | 9 |
Version 3.0 SW_G2
Figure 00 (Um Xl C Cover)
C Variant
User Manual
Manufacturer: Biofrontera Discovery GmbH
Distributor: Biofrontera Inc.
Foreword
Thank you for choosing the RhodoLED® XL-C LED lamp for your photodynamic therapy. RhodoLED® XL-C 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 group RhodoLED® XL-C have been approved in combination for photodynamic therapy; the only approved use of our lamp is in combination with Ameluz® gel. RhodoLED® XL-C belongs to the RhodoLED® XL product group.
This user manual provides important RhodoLED® XL-C product details, precautions and warnings, and operating instructions. For Ameluz®, please use its US prescribing information (USPI). The Ameluz® prescribing information includes information on how to use the gel along with contraindications, warnings and precautions, and dosage and administration.
The product labels/ markings shown in this manual are examples. They may differ slightly from those on the lamp.
Thorough reading and use of both this user manual and the Ameluz® USPI is required prior to treatment.
Our combination Ameluz®/RhodoLED® XL-C for photodynamic therapy is only to be used by physicians or healthcare professionals.
For further questions about Ameluz®, RhodoLED® XL-C, or the combination therapy, please contact your sales representative or Biofrontera ([email protected]). See contact information below or visit us at http://www.biofrontera.us.com/
Sales representative: Name: Tel.: E-mail: | Biofrontera Inc. 660 Main Street |
Warranty and Disclaimers
Please see the terms and conditions of your contract for this information.
Manufacturer
Biofrontera Discovery GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany
"AMELUZ and RHODOLED are registered trademarks of Biofrontera Inc. ©2026 Biofrontera Inc. All rights reserved.”
1 Intended Use
RhodoLED® XL-C is a red light-emitting LED lamp, which is used exclusively in combination with Ameluz® gel for the treatment of:
2 RhodoLED® XL-C - General Description
RhodoLED® XL-C 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
 Symbol 02 (Um Xl C Symbol 02) | The RhodoLED® XL-C 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. |
| Symbol 02 (Um Xl C Symbol 02) | 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® USPI section 6. |
 Symbol 03 (Um Xl C Symbol 03) | The user manual must be read carefully prior to using the RhodoLED® XL-C. |
| Symbol 02 (Um Xl C Symbol 02) | The RhodoLED® XL-C may only be used by healthcare professionals who have received adequate training in its use. |
 Symbol 04 (Um Xl C Symbol 04) | Bright light, do not stare into the light source |
 Symbol 05 (Um Xl C Symbol 05) | Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006. |
 Symbol 06 (Um Xl C Symbol 06)  Symbol 44 (Um Xl C Symbol 44) | Distance sensor of RhodoLED® XL-C 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. |
 Symbol 08 (Um Xl C Symbol 08) | Risk of trapping fingers! Depending on positioning, fingers can be trapped between LED panels and the holding bracket, between the movable part and the fixed part of the lamp head holding bracket. |
| Symbol 02 (Um Xl C Symbol 02) | Neither the RhodoLED® XL-C 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. |
| Symbol 02 (Um Xl C Symbol 02) | In order to avoid the risk of electrical shock, the device may only be connected to a power supply with a grounded connection. |
| Symbol 02 (Um Xl C Symbol 02) | Neither the RhodoLED® XL-C 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). |
 Symbol 09 (Um Xl C Symbol 09) | The RhodoLED® XL-C 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 %. |
| Symbol 09 (Um Xl C Symbol 09) | 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. |
| Symbol 09 (Um Xl C Symbol 09) | 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. |
| Symbol 09 (Um Xl C Symbol 09) | Ensure that the control unit is always returned to parking position to avoid damage during transport. |
| Symbol 09 (Um Xl C Symbol 09) | The control unit should not be exposed to strong external pressure or sharp objects. |
| Symbol 09 (Um Xl C Symbol 09) | A person trained in operation of the RhodoLED® XL-C must always be present during treatment. |
| Symbol 09 (Um Xl C Symbol 09) | Before treating affected skin area with the topical medication check the proper functioning of the RhodoLED® XL-C. Do not use a damaged device for treatment. |
| Symbol 09 (Um Xl C Symbol 09) | RhodoLED® XL-C is intended for operation in non-residential facilities and similar environments that are connected directly to a public low-voltage supply network that also supplies residential buildings. RhodoLED® XL-C 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 |
| Symbol 09 (Um Xl C Symbol 09) | The RhodoLED® XL-C 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. |
| Symbol 09 (Um Xl C Symbol 09) | 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. |
| Symbol 09 (Um Xl C Symbol 09) | The device must be protected against unauthorized use. |
| Maintenance and initial set up of the RhodoLED® XL-C 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. |
4 RhodoLED® XL-C Technical Description
4.1 Light emitting diodes (LED)
RhodoLED® XL-C 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-C 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 01 (Um Xl C Figure 01)
Figure 1: LED panels with LED distribution and emission spectrum of RhodoLED® XL-C LEDs.
The RhodoLED® XL-C 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 10 minutes
- Treatment distance of 4.9 ± 0.6 inches (12.5 cm ± 1.5 cm)
The illumination area of the LED lamp is 9.06 x 11.42 inches (23 cm x 29 cm) for all panels.
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-C Components
The RhodoLED® XL-C consists of the following main components (Figure 2):
Figure 02 (Um Xl C Figure 02) 
Figure 2: RhodoLED® XL-C main components
5 Operating environment of RhodoLED® XL-C
RhodoLED® XL-C shall be operated in environments of professional health care facilities. For a detailed description of electromagnetic compatibility see chapter 15. RhodoLED® XL-C is intended for operation in non-residential facilities and similar environments that are connected directly to a public low-voltage supply network that also supplies residential buildings.
6 Eye Protection
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-C 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.
| Symbol 05 (Um Xl C Symbol 05) | Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006. |
7 RhodoLED® XL-C PDT Summarized Step-by-Step Instruction
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-C must be trained in operating the device. The initial training is provided by Biofrontera during set-up of the RhodoLED® XL-C. 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-C is in good working order.
| STEP 1) | Plug in the lamp. |
| STEP 2) | Turn on the lamp and wait for the home screen to appear (see chapter 8.4.3). |
| STEP 3) | Check the proper functioning of the RhodoLED® XL-C. |
| STEP 4) | Treat the affected skin area: Application, incubation, and removal of the topical medication according to the USPI of Ameluz®. |
| STEP 5) | Position the patient comfortably and equip the patient with protective eyewear (see chapter 0). |
| STEP 6) | Select active panels (see chapter 8.4.5). |
| STEP 7) | Position the lamp and adjust the lamp head over the skin area to be treated (distance 4.9 inches /12.5 cm) (see chapter 0). |
| STEP 8) | Put on protective eyewear and make sure anyone remaining in the treatment room also wears protective eyewear (see chapter 0). |
| STEP 9) | Start treatment by pressing Start, the illumination period begins (see chapter 8.4.9). Remind the patient to remain still throughout the illumination period. If audible indicators during treatment are activated, explain the sounds to the patient. If the patient needs a break, press Pause on the screen. To resume treatment, press Resume (see chapter 8.4.10). To abort the illumination, press Cancel (see chapter 8.4.10). Always stay with the patient during the illumination period. |
| STEP 10) | At the end of the illumination period, remove patient's protective eyewear and follow further instructions in the Ameluz® USPI. |
8 Detailed Operating Instructions
Note: Every user of the RhodoLED® XL-C must be trained in operating the device. The initial training is provided by Biofrontera during set-up of the RhodoLED® XL-C. Recurrent training is not mandatory but can be provided by Biofrontera employees. The device must be protected against unauthorized use.
| Symbol 05 (Um Xl C Symbol 05) | Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006. |
8.1 Transport of RhodoLED® XL-C and Spring Arm Lock Function
During transportation the RhodoLED® XL-C 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-C is placed on the left side (see Figure 3).
Figure 03 (Um Xl C Figure 03)
Figure 3: Transport position of RhodoLED® XL-C 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
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°.
Figure 04 (Um Xl C Figure 04)
Figure 4: Rotation and tilting of the lamp head.
The control unit can be turned from the left to the right side of the device (see Figure 5). 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.
Figure 05 (Um Xl C Figure 05)
Figure 5: Control unit positions
8.3 Turning RhodoLED® XL-C On and Off
Note: Before turning on the lamp, the power cord must be plugged into a power outlet. RhodoLED® XL-C is intended for operation in non-residential facilities and similar environments 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 power supply during operation.
The RhodoLED® XL-C 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-C 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 06 (Um Xl C Figure 06)
Figure 6: Control unit of RhodoLED® XL-C with power button
8.4 RhodoLED® XL-C Controls
8.4.1 Control Unit
The touchscreen of the control unit can be used while wearing commercially available examination gloves.
8.4.2 Splash Screen
The Biofrontera corporate logo and software version are displayed during the LED lamp operating system start-up (Figure 7). The operating system takes approximately 10 seconds to load.
Figure 07 (Um Xl C Figure 07)
Figure 7: Splash screen
8.4.3 Home Screen
The home screen appears after the operating system has loaded.
Figure 08 (Um Xl C Figure 08)
Figure 8: Home screen
8.4.4 The Treatment Profile
The RhodoLED® XL-C has a fixed LED light intensity which ensures the application of 37 J/cm² within the 10-minute treatment time.
8.4.5 Selecting Active LED Panels
The device has 5 LED panels which are also displayed by the software (Figure 9). 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 10).
Figure 09 (Um Xl C Figure 09)
Figure 9: Software illustration of RhodoLED® XL-C LED panels (all panels are activated)
Figure 10 (Um Xl C Figure 10)
Figure 10: Panel number at the backside of the panel
Deactivated panels are displayed in grey with a power symbol in their centers (Figure 11). Activated panels are highlighted and the current distance to the treatment area is displayed.
Figure 11 (Um Xl C Figure 11)
8.4.6 Treatment Area
The illumination area of RhodoLED® XL-C is 9.06 x 11.42 inches (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 12 as guidance).
Figure 12 (Um Xl C Figure 12)
Figure 12: Treatment area of RhodoLED® XL-C 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 one outer panel to the midline of the other outer panel.
If 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
The correct treatment distance for the RhodoLED® XL-C is 4.9 ± 0.6 inches (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 11).
Table 1: Adjusting the treatment distance
| Pictogram | Meaning |
 Symbol 24 (Um Xl C Symbol 24) | Treatment distance is correct for this LED panel (4.9 ± 0.6 inches / 12.5 ± 1.5 cm), adjustment light is/turns on |
 Symbol 25 (Um Xl C Symbol 25) | Treatment distance is too small for this LED panel. LED panel must be further away from treatment area, adjustment light is/turns off |
 Symbol 26 (Um Xl C Symbol 26) | Treatment distance is too large for this LED panel. LED panel must be closer to the treatment area, adjustment light is/turns off |
 Symbol 27 (Um Xl C Symbol 27) | This LED panel is switched off |
8.4.8 Adjustment Light
If the correct treatment distance of 4.9 inches (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 inches (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 11).
Figure 13 (Um Xl C Figure 13)
Figure 13: Low light intensity for correct adjustment of LED panels.
8.4.9 Starting an Illumination
To start a treatment, press the Start button. Before starting the treatment make sure every person present wears the correct eye protection (see chapter 0) and confirm the query for eye protection (Figure 14).
| Symbol 05 (Um Xl C Symbol 05) | Protective eye wear must be used by patient, healthcare providers and any persons present during the illumination period. Do not stare in the LED beam. LEDs are classified in the exempt group according to IEC 62471:2006. |
Figure 14 (Um Xl C Figure 14)
Figure 14: 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 15).
Figure 15 (Um Xl C Figure 15)
Figure 15: Treatment progress.
8.4.10 Pause, continue, or cancel a treatment
Figure 16 (Um Xl C Figure 16)
Figure 16: 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 17).
Figure 17 (Um Xl C Figure 17)
Figure 17: 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.
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
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).
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.
8.5 Settings Menu
 Symbol 34 (Um Xl C Symbol 34) | To open the settings menu, select the gear symbol in the upper right corner of the screen. |
The settings menu is organized in the tabs General, Service and Info.
Figure 18 (Um Xl C Figure 18)
Figure 18: The settings menu is organized in the three main tabs General, Service and Info
8.5.1 Language
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.
8.5.2 Distance Units
Unit settings are part of the General settings tab. The distance of the LED panels to the treatment area can be displayed in inches 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.
8.5.3 Auto power off
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.
8.5.4 Sound Settings
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.
Note: The audio signals are very low in volume and may not be audible to the patient during operation.
Note: Warning sounds will be emitted if an error occurs during operation of the lamp. Warning sounds cannot be turned off.
8.5.5 Info-Tab
The system status provides information about the current hardware and software status of the device.
This includes information about:
• 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.
8.5.6 Service Menu
 Symbol 36 (Um Xl C Symbol 36) | Authorization is required to access the service menu. Only authorized personnel can access the service menu. See also chapter 10. |
9 Error Messages
The RhodoLED® XL-C 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.
| Error code | Possible causes | Measures |
| 001 System error | Error in system of the device | - Confirm the system error - Please contact your local sales representative or Biofrontera |
| 002 Communication error | Communication between the control unit and the LED panels disturbed | - Confirm the communication error - Treatment can be continued by confirming the message dialog - Please contact your local sales representative or Biofrontera - If there is a permanent error in the communication, no further treatment is possible |
003 Panel error  Symbol 37 (Um Xl C Symbol 37) | Error in the control of one or more LED panel Defective LED panels are marked with a red triangle | - Confirm the Panel error - Treatment can be continued by confirming the message dialog - Please contact your local sales representative or Biofrontera |
| 004 Distance sensor error | Error in control of the distance sensors | - Confirm the Distance sensor error - Treatment can be continued by confirming the message dialog - Please contact your local sales representative or Biofrontera |
| 005 Update process error | The software needs updating | - Please contact your local sales representative or Biofrontera |
| 006 Temperature sensor error | Defective temperature sensor or defect in temperature sensor control | - Confirm the Temperature sensor error - Treatment can be continued by confirming the message dialog - Please contact your local sales representative or Biofrontera |
| 007 Cooling system error | The ventilators or ventilator slots are blocked The air inlets or outlets are adversely affected | - Check the ventilators and test the air inlets and outlets - Remove any visible foreign objects which may be present |
| The treatment is paused due to an overheated LED panel. Wait until normal temperature is reached. | The temperature is too high | - Wait until the standard temperature has been reached - Treatment can then be resumed |
If your RhodoLED® XL-C no longer functions properly for some unknown reason, proceed as follows:
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.
Please have the system status (chapter 8.5.5) available if you contact your sales representative or Biofrontera.
10 Servicing and repairs
Servicing and repairs may only be performed by Biofrontera-authorized personnel. For RhodoLED® XL-C no spare parts for replacement by the user are available.
Device is not serviced while in use with patients.
If servicing or repairs are done by third parties, RhodoLED® XL-C warranty is void and Biofrontera cannot be held responsible for potential malfunctions of or damages to the device or the patients.
Figure 19 (Um Xl C Figure 19)
Figure 19: Servicing and maintenance may only be performed by Biofrontera
11 Maintenance and Cleaning
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, as RhodoLED® XL-C 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:
| Daily: | Wipe the plexiglass screen located on the bottom of the lamp head with a damp soft cloth (e.g., a microfiber cloth). |
| Weekly: | 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, Multi-Purpose Cleaners (Clorox Healthcare VersaSure Wipes) or pre-soaked disinfection wipes based on quaternary ammonium compounds (e.g. Cavi wipes XL or Clorox disinfection wipes). |
| Please observe the following checks: | |
| Monthly: | 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. |
12 Disposal Instructions
Follow all local and governmental disposal laws and regulations when disposing of the RhodoLED® XL-C.
13 Technical Data
13.1 Electrical Connectors
Power supply unit:
LED controller board:
LED board:
Human Machine Interface (HMI) for operation:
13.2 Specification
| Type | RhodoLED® XL Medical device class III; Device of protection class 1 |
| Certification | UL certified E513735 |
| Manual is valid for Software Version No. | g2.15.00.3911 |
| Service interval | Biofrontera recommends performing service every 2 years |
| Number of LEDs | 225 |
| Typical peak wavelength | 635 nm ± 5 nm |
| Light dose | Approx. 37 J/ cm2 at 4.9 inches (12.5 cm) distance, 10 min |
| Typical irradiance | approx. 60 mW/cm² ± 20 % at 4.9 inches (12.5 cm) distance |
| Max irradiance | approx. 72 mW/cm² at 4.9 inches (12.5 cm) distance |
| Illuminated area | An area of 9.06 x 11.42 inches (23 cm x 29 cm) is illuminated using all panels in curved shape. |
| Max. deviation of the intensity over the treatment area | Approx. 20 % |
| Treatment distance | 4.9 ± 0.6 inches (12.5 cm ± 1.5 cm) |
| Transport conditions | Temperature: -4°F to +140°F (-20°C to +60°C) |
| Storage conditions | Temperature: +59°F to +95°F (+ 15°C to +35°C) |
| Operating conditions | Temperature: +59°F to +86°F (+15°C to + 30°C) |
| Operating voltage | 100-120 VAC, 60 Hz |
| Output voltage | 48 VDC |
| Power consumption | In normal operation: approx. 750 VA |
| Over-voltage category | II |
| Degree of contamination | 2 |
| Material group (CTI) | IIIb |
| Protection class | IP20 |
| Size of the lamp | Height 5.76 ft (175.5 cm) Width: 2.51 ft (76.4 cm) Depth: 3.19 ft (97.1 cm) |
| Total lamp weight | 165 lb. (75 kg) |
For further information please directly contact Biofrontera.
14 Labeling and Symbols
14.1 Label on the Lamp Base
Figure 20 (Um Xl C Figure 20)
Figure 20: Product label (serial number and date of manufacturing vary) with UDI code of RhodoLED® XL-C on lamp base, individual code depends on the serial number and date of manufacturing of the device.
Figure 21 (Um Xl C Figure 21)
Figure 21: No stepping on the device, no disposal in household waste, information on setup and service.
Figure 22 (Um Xl C Figure 22)
Figure 22: Instruction for ground connector connection (not visible from the outside)
14.2 Label on LED Panels
Figure 23 (Um Xl C Figure 23)
Figure 23: Instruction and notes on the LED panels
Figure 24 (Um Xl C Figure 24)
Figure 24: LED Panel numbering from Panel 1 to Panel 5
14.3 Description of Symbols
| Symbol | Description |
| Symbol 05 (Um Xl C Symbol 05) | Eye protection is required. |
| Symbol 44 (Um Xl C Symbol 44) Symbol 06 (Um Xl C Symbol 06) | Distance sensor of RhodoLED® XL-C is a class 1 laser product. A class 1 laser product is safe under all conditions of normal use. |
| IP20 | IP (Ingress Protection): Protection class of the housing against contact, foreign bodies and water 2 = against ingress of solid foreign bodies ≥ 12.5 mm Ø and larger 0 = Not protected against water |
 Symbol 45 (Um Xl C Symbol 45) | 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. |
 Symbol 46 (Um Xl C Symbol 46) | Symbol for existing ground connector connections |
| Symbol 03 (Um Xl C Symbol 03) | Follow the instructions for use! |
| Symbol 02 (Um Xl C Symbol 02) | General warning signs:
|
| Symbol 08 (Um Xl C Symbol 08) | Warning sign - risk of trapping fingers! |
| Symbol 04 (Um Xl C Symbol 04) | Bright light, do not stare into the light source |
 Symbol 47 (Um Xl C Symbol 47) | Do not step on the device. |
15 Electromagnetic compatibility
RhodoLED® XL-C 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.
| Guidelines and manufacturer's declaration - electromagnetic emissions | ||
RhodoLED® XL-C 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.
| ||
| Emission readings | Conformity | Electromagnetic environment - guidelines |
| HF emissions CISPR 11 | Group 1 | RhodoLED® XL-C 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. |
| HF emissions in accordance with CISPR 11 | Class A | RhodoLED® XL-C is intended for operation in non-residential facilities and similar environments that are connected directly to a public low-voltage supply network that also supplies residential buildings. |
| Harmonics in accordance with IEC 61000-3-2 | Class A | |
| Voltage fluctuations/flickers in accordance with IEC 61000-3-3 | In compliance | |
| Guidelines and manufacturer's declaration - electromagnetic immunity | |||
| RhodoLED® XL-C 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. | |||
| Immunity tests | IEC 60601 test levels | Compliance level | Electromagnetic environment - guidelines |
| Static discharge in accordance with IEC 61000-4-2 | ±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge | ±8 kV contact discharge ±2 kV, ±4 kV, ±8 kV and ±15 kV air discharge | 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%. |
| Fast, transient electrical disturbances/bursts in accordance with IEC 61000-4-4 | ±2 kV for mains lines 100 kHz repetition frequency | ±2 kV for mains lines | The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. |
| Surges in accordance with IEC 61000-4-5 | ±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth | ±1 kV voltage outer conductor - outer conductor ±2 kV outer conductor - earth | The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. |
| Voltage dips, brief interruptions and fluctuations in the supply voltage in accordance with IEC 61000-4-11 | 0 % UT 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) 0 % UT for 1 cycle 70 % UT for 25/30 cycles 0 % UT for 250/300 cycles | 0 % UT 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) 0 % UT for 1 cycle 70 % UT for 25/30 cycles 0 % UT for 250/300 cycles | The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. 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. |
| Power frequency (50/60 Hz) magnetic field in accordance with IEC 61000-4-8 | 30 A/m | 30 A/m | Mains frequency magnetic fields should correspond to the values typically found in the commercial and hospital environment. |
| Comment: UT is the mains AC voltage prior to application of the test level | |||
| Guidelines and manufacturer's declaration - electromagnetic immunity | |||
| RhodoLED® XL-C 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. | |||
| Immunity tests | IEC 60601 test levels | Compliance level | Electromagnetic environment - guidelines |
Conducted HF disturbances in accordance with IEC 61000-4-6 | 3 V 150 kHz to 80 MHz 6 V | 3 V 6 V | 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. |
Radiated HF disturbances in accordance with IEC 61000-4-3 | 3 V/m 80 MHz to 2.7 GHz 80 % AM with 1 kHz | 3 V/m | Interference may occur in the vicinity of equipment marked with the following symbol.  Symbol 48 (Um Xl C Symbol 48) |
| 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. | |||
| Recommended safety distances between portable and mobile HF telecommunication devices and the RhodoLED® XL-C. |
| 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 RhodoLED® XL-C. Failure to do so may result in a reduction in the performance of the device. RhodoLED® XL-C should not be used directly alongside or between other electrical equipment. |
| Guidelines and manufacturer’s declaration – proximity fields from RF wireless communication equipment | ||
| RhodoLED® XL-C 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. | ||
| Service | Frequency range/ discrete frequencies MHz | Compliance level [V/m] |
| TETRA 400 | 385 | 27 |
| GMRS 460, FRS 460 | 450 | 29 |
| LTE Band 13, 17 | 710 745 780 | 9 |
| GSM 800/900, TETRA 800, iDEN 820, CDMA, LTE Band 5 | 810 870 930 | 28 |
| GSM 1800, CDMA 1900, GSM 1900,DECT, LTE Band 1,3,4, 25 | 1720 1845 1970 | 28 |
| Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 | 2450 | 28 |
| WLAN 802.11 a/n | 5240 5500 5785 | 9 |
Version 2.0 SW_G2
Figure6 (Figure6)
Outer Packaging, single Carton
NDC 70621-101-10
Ameluz® Rx Only
(aminolevulinic acid HCl) topical gel, 10%
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).
Keep out of the sight and reach of children.
See package insert for dosage information. Net Wt. 2 g
Distributed By: Biofrontera Inc.
660 Main Street, 1st Floor
Woburn, MA 01801
Product of Switzerland
For Topical Use Only with BF-RhodoLED® or RhodoLED® XL lamp
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
Outer Packaging, Physician's Sample
NDC 70621-101-30
Ameluz® Rx Only
Physician's Sample
Not for sale
(aminolevulinic acid HCl) topical gel, 10%
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).
Keep out of the sight and reach of children.
See package insert for dosage information. Net Wt. 2 g
Distributed By: Biofrontera Inc.
660 Main Street, 1st Floor
Woburn, MA 01801
Product of Switzerland
For Topical Use Only with BF-RhodoLED® lamp or RhodoLED® XL lamp
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
Outer Packaging, Multipack
10 tubes with Net Wt. 2g each NDC 70621-101-20
Ameluz® Rx Only
(aminolevulinic acid HCl) topical gel, 10%
For Topical Use Only with BF-RhodoLED® lamp or RhodoLED® XL lamp
Healthcare Professionals Only
See package insert for dosage information.
Distributed By: Biofrontera Inc.
660 Main Street, 1st Floor
Woburn, MA 01801
Product of Switzerland
10 tubes with Net Wt. 2g each NDC 70621-101-20
Ameluz® Rx Only
(aminolevulinic acid HCl) topical gel, 10%
Use contents within 3 months after opening the individual tube.
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).
Keep out of the sight and reach of children.
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
Distributed By: Biofrontera Inc.
660 Main Street, 1st Floor
Woburn, MA 01801
Product of Switzerland
* Please review the disclaimer below.
