The Dermalux® Flex MD is a Light Emitting Diode (LED) Phototherapy system designed for both professional and at-home use. It emits low-level light energy from the visible and infrared regions of the light spectrum, specifically Blue 415nm, Red 633nm, and Near Infrared 830nm wavelengths. The device is indicated for the treatment and management of a wide range of cosmetic, dermatological, and medical conditions, including Skin Rejuvenation, Acne, Pigmentation, Redness, Psoriasis, Wound Healing, and Musculoskeletal Pain.
Function Description:
The Flex MD system consists of a Base unit, a flexible LED Array, a capacitive touch Controller, a power supply unit (100-240Vac, 50/60Hz), and an RJ11 cable. The flexible LED Array can be used in the Base for facial treatments or removed to treat larger body areas by laying the device directly over the treatment area. The system offers seven treatment protocols via various wavelength combinations, selected through the Controller. The light is generated by Light Emitting Diodes (LEDs) contained within the flexible LED Array. The device is switched ON/OFF by a button on the Controller.
Important Technical Specifications:
- Wavelengths: Blue 415nm, Red 633nm, Near Infrared 830nm.
- Optical Power:
- Blue (415nm): 10 j/cm²
- Red (633nm): 20 j/cm²
- NIR (830nm): 10 j/cm²
- Operating Time per Treatment: 30 minutes (maximum).
- Optical Variation: Maximum 10% optically.
- Ocular Hazard Distance (EN 60601-2-57): 0.025m when in use with the Base unit, 0.0m when directly placed on the body.
- Risk Group: EN 62471 Risk Group 2.
- Mains Supply: 100-240 Vac, 50/60 Hz, 1A.
- PSU Output: 30Vdc, 1.2A, 36W.
- Weight: 2.5kg.
- Footprint (in Base Unit): W520 x L335 x H300 mm.
- Footprint (Array in flat position): W280 x L790 x H30 mm.
- Duty Cycle: Continuous.
- IP Rating: IP20.
- Operating Conditions: 5-40 degrees Celsius, 15-90% humidity, 70-106 kPa atmospheric pressure.
- Storage & Transit Conditions: -25 to +70 degrees Celsius, up to 90% humidity, 50-106 kPa atmospheric pressure.
Usage Features:
- Quick Start Guide: The device is assembled according to the Assembly Guide (PL-028) and connected to a mains socket. The power button on the Controller illuminates green upon activation. The timer screen displays the Dermalux® logo, then the Flex MD logo, followed by "30." (minutes).
- Control Buttons:
- Power: Turns the device on and off.
- Blue: Activates Blue LEDs for treatment (button illuminates blue).
- Red: Activates Red LEDs for treatment (button illuminates red).
- NIR: Activates Near Infra-Red LEDs for treatment (button illuminates yellow; NIR light is invisible to the human eye).
- Play: Initiates a 30-minute treatment with pre-selected LED wavelengths. The button changes from red to green when treatment starts and reverts to red when paused.
- Treatment Protocols: Seven treatment options are available, including single-wavelength (Blue, Red, NIR), dual-wavelength (Blue & Red, Blue & NIR, Red & NIR), and Tri-Wave treatments.
- Setup and First Use: No warm-up period is required. If stored above normal room temperature, allow appropriate time to cool (max 15 minutes). The device is safe to use from minimum storage temperature (-25°C).
- Eye Safety: Client goggles are supplied for comfort and safety. Users are warned not to stare at the operating LED Array, as it may be harmful to the eyes. Protective eyewear should be worn by the patient when the device is in use.
- Positioning: The device should be set up and positioned around the user's face with a minimum distance of 25mm between the LED Array and the user to mitigate unintended exposure. The distance determines the j/cm² of emitted light, with lower optical power density further from the device.
- Contraindications and Precautions: Treatment is generally safe but unsuitable for individuals with epilepsy/seizures triggered by light, porphyria, systemic lupus erythematosus (SLE), photosensitive eczema, active cancers, or those using photosensitive medications. Precautions apply to clients with eye diseases (glaucoma, cataracts, recent laser eye surgery) or light-induced migraines.
- Photosensitivity: Users are warned about photosensitivity, a condition characterized by increased sensitivity to light, potentially caused by certain medical conditions, medications (antibiotics, chemotherapy drugs, diuretics), and substances (St John's Wort, anti-perspirants, certain perfumes). Symptoms include erythema similar to sunburn.
- Known Risks: Skin may feel warm and appear red after treatment (returns to normal within 1-2 hours). Temporary headaches are rare and can be treated with pain killers and rehydration. No known allergic reactions to materials.
Maintenance Features:
- Cleaning: The system must be switched off and unplugged before cleaning. The entire surface (LED Array, Base unit, Controller) can be cleaned with an anionic detergent towelette or surface wipe. Excess moisture should be removed with a clean, dry microfibre cloth. Avoid other cleansing products to prevent damage to plastics or electrical components. The device must be thoroughly cleaned between clients if used directly on the body.
- Routine Maintenance: No manufacturing maintenance or annual service is required. Customers are expected to perform routine maintenance (cleaning, general health inspections, visual inspection of wires, material integrity, and damage signs) quarterly.
- Servicing Requirements: The Dermalux® Flex MD system contains no serviceable parts and does not require calibration or annual maintenance service. Faults within the warranty period should be reported for a replacement device.
- Disposal: The product has a lifetime of 2 years. Do not dispose of any part of the system at a domestic waste facility. Follow local council advice or return the unit to Aesthetic Technology Ltd for proper disposal in accordance with Directive 2002/96/EC (WEEE).
Safety Warnings:
- Do not stare at the operating LED Array.
- Do not connect/disconnect power cable or controller when power is live.
- Use only the original power supply.
- Keep small parts out of reach of children.
- Avoid using adjacent to or stacked with other equipment.
- Avoid dusty, dirty, or high-temperature environments (direct sunlight).
- Place the LED Array in a flat position when storing.
- Do not use other cleaning products than specified.
- Keep the system switched off when not in use.
- Avoid contact with children and animals.
- Unplug from the mains outlet socket for full isolation.
- Be cautious of the power lead as a trip or strangulation hazard.
- Plug into a direct mains outlet, avoid extension cables or adaptors.
- Do not use near water/liquids or if the LED Array has contacted water/liquids.
- Do not plug/unplug/activate with wet hands.
- Do not use in the presence of flammable liquids or gases.
- Do not disassemble any parts.
- Do not operate if damaged.
- Do not modify the system.
- Avoid using portable RF communications equipment closer than 30 cm (12 inches).
- Avoid use around children and animals to prevent unnecessary risk.
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