Thank you for choosing the BF-RhodoLED® LED lamp for your photodynamic therapy. BF-RhodoLED® has been developed in accordance with applicable technical standards to provide high energy efficiency as well as constant light emission at the desired wavelength.
Your lamp must be installed and maintained by a qualified Biofrontera technician and used only in accordance with the instructions in this manual. You may request the latest printed version covering this model from Biofrontera at any time.
Our drug Ameluz® and medical device BF-RhodoLED® have been approved in combination for photodynamic therapy; the only approved use of our lamp is in combination with Ameluz® gel. This user manual provides important BF-RhodoLED® product details, cautions and warnings, and operating instructions. For Ameluz®, please use its US prescribing information. The Ameluz® prescribing information includes information on how to use the gel along with contraindications, warnings and precautions and dosage and administration.
Thorough reading and use of both this user manual and the Ameluz® USPI is required prior to treatment.
Our combination Ameluz®/BF-RhodoLED® for photodynamic therapy is only to be used by physicians or healthcare professionals.
For further questions about Ameluz®, BF-RhodoLED® or the combination therapy please contact your sales representative or Biofrontera (Ameluz-US@biofrontera.com). See contact information below or visit us at http://www.biofrontera.us.com/
Warranty and Disclaimers
Please see the terms and conditions of your contract for this information.
Manufacturer
Biofrontera Pharma GmbH, Hemmelrather Weg 201, 51377 Leverkusen, Germany
"AMELUZ, RHODOLED and BF-RhodoLED are registered trademarks of Biofrontera Pharma GmbH.
©2024 Biofrontera Pharma GmbH. All rights reserved."
BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® gel for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.
2 BF-RhodoLED® - General Description
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.
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).
The light-field of the BF-RhodoLED® consists of a total of 128 LEDs and lenses (arranged in a rectangle), which emit a uniform, bundled, visible red light with a typical peak wavelength of approximately 635 nm. The half-band width of the lamp is 20 nm.
Figure 2: Typical emission spectrum of the LEDs of the BF-RhodoLED®. Insert: Fluorescence excitation spectrum of PPIX in cells 0, 3 and 6 mm below the tissue surface (Moan et al., 1996)
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.
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.
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.
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.
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).
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 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 button on the touchscreen (see chapter 7.4.2 "Home Screen").
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.
The home screen appears after the operating system has loaded. From the home screen you can select "Treatment", "Settings" or "Service" (Figure 8). In the "Treatment" menu only one treatment profile "profile standard" is available. The illumination time and light intensity of this program are fixed (see 7.5.3 for further information). The "Settings" menu allows adjustment of language, time, date, audio signals and power saving settings (see 7.6 for further information). The "Service" menu may only be accessed by authorized personnel. You can turn the LED lamp off by pressing the button.
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).
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).
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).
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.
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
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".
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.
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.
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.
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:
11 Disposal Instructions
Follow all local and governmental disposal laws and regulations when disposing of the BF-RhodoLED®.
Mother board for voltage management and control:
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. In addition, a unique device identifier label is placed next to the product sticker.
Figure 18: Product and UDI label. (The appearance of devices from batches 001 to 003 slightly differs. Appearance and location of the labels remain unaltered.)
Labels with safety instructions, special disposal instructions and further instructions are represented in the following figures.
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 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.)
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 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".
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.