Technical Specification General Safety Warnings 26.1 Electromagnetic Guidance To Reduce The Risk Of Damaging The System Labelling Eye Safety Basic User Approach Receiving the Dermalux® Flex MD System Warranty Using the Device Fault Reporting 19.1 Assembly Guide Troubleshooting 19.2 Setup and First Use Manufacturers Declaration 19.3...
2. Important Safety Notice Reading this User Guide is mandatory before attempting to operate Thank you for choosing the Dermalux® Flex MD LED Phototherapy system. This User Guide covers the Dermalux® Flex MD system. It is important to follow the operating the operational and technical aspects of the system.
Aesthetic Technology Limited 4. Device Description 5. Device Components The Dermalux® Flex MD is a Medical Device for use on a treatment bed with a floor • Flex MD Base Unit • Client Goggles standing option also available. The device emits specific wavelengths of low level, narrow •...
6. Flex MD Quick Start Guide Unpack and assemble the device as per PL-028 Assembly Guide found in Section 3. Upon activation, the timer screen will display the Dermalux® logo, followed by the 19 of the User Guide. Flex MD logo.
Prior to treatment, we strongly recommend that all clients complete and sign the The Dermalux® Flex MD system delivers three clinically proven wavelengths via 7 Dermalux® Consent Form (PL-012, available at learn.dermaluxled.com) and disclose treatment options selected through the Controller.
Exposure to either a chemical or the light alone is not sufficient to induce a photosensitive reaction. When photo-activation of a chemical occurs, a phototoxic or photoallergic reaction may arise. For a list of Photosensitive Medications, please refer to the Dermalux Consultation Guide (PL-011, available at learn.dermaluxled.com). PL-027 (Rev 7)
The Dermalux® Flex MD device has NOT been tested on pregnant women and therefore In the unlikely event of a product fault or an adverse response to the Dermalux® Flex MD the risk to the foetus or pregnant woman is unknown. Administration of the treatment during treatment, please report the issue to Aesthetic Technology Ltd or your local Dermalux pregnancy would strictly be at the users or practitioners discretion.
Aesthetic Technology Limited 15. General Safety Warnings The Dermalux® Flex MD system is an electrical device, which under certain circumstances Do not plug, unplug or activate the system with wet hands. could present an electrical shock hazard to the user. Please follow the directions stated in Do not use the system in the presence of flammable liquids or gases.
WARNING! If any of the individual components are missing or damaged listed in Section 5 of this document, please contact Aesthetic Technology Ltd or your local Dermalux® representative • Do not place the system in a dusty or dirty environment.
Aesthetic Technology Limited 19. Using the Device 19.1.1. Unpacking and Set Up of Flex MD 19.1 Assembly Guide Goggles Assembled Background LED Array User Guide The Flex MD is delivered in one box (the product box) wrapped in another box (the transport box).
Press the power button on the Controller to activate • Display will illuminate with the following, in order: Step 4: Connect Power Supply via port in LED Array and plug directly into - Dermalux logo a mains socket. See Image 4. - Flex MD logo - 30 (minutes) •...
Description Reference ID Once the Dermalux® Flex MD is connected to a mains socket, switch on using the power button on the Controller (the button will light up in green). Refer to icon in Table 2 on page 25. Button Reference ID 1.
Aesthetic Technology Limited 19.4.2 Detailed Software Walk Through Button/ ID Function Requirement Upon successful completion of initialisation, the POWER 1. If the POWER button is pressed at any time the device will turn off and any treatment button will illuminate in green. will be cancelled.
Aesthetic Technology Limited 19.4.3 Red 633nm Treatment 19.4.4 Blue 415nm Treatment Button/ ID Function Requirement Button/ ID Function Requirement Press the RED button to activate the red LED’s. Press the BLUE button to activate the blue LED’s. This is indicated by the button illuminating in red. This is indicated by the button illuminating in blue.
Aesthetic Technology Limited 19.4.5 NIR 830nm Treatment 19.4.6 Blue & Red Treatment Button/ ID Function Requirement Button/ ID Function Requirement Press the NIR button to activate near infra-red LED’s. Press the BLUE button to activate the blue LED’s. This is indicated by the button illuminating in yellow. This is indicated by the button illuminating in blue.
Aesthetic Technology Limited 19.4.7 Blue & NIR Treatment 19.4.8 Red & NIR Treatment Button/ ID Function Requirement Button/ ID Function Requirement Press the RED button to activate red LED’s. Press the BLUE button to activate blue LED’s. This is indicated by the button illuminating in blue. This is indicated by the button illuminating in red.
Aesthetic Technology Limited 19.4.9 Tri-Wave Treatment 20. Cleaning Instructions It is important that the Dermalux® Flex MD system is switched off and unplugged from the Button/ ID Function Requirement mains power socket before cleaning. Press the BLUE button to activate blue LED’s.
Environmental conditions for transport and storage: -25 to +70 degrees Celsius and up to Do NOT dispose of any part of the Dermalux® Flex MD LED system at a domestic waste 90% humidity (normal range for room temperature conditions). Atmospheric pressure range facility.
Aesthetic Technology Limited 26. Technical Specification 26.1 Electromagnetic Guidance Emissions Test Compliance • Blue (415nm) - Maximum optical power is 10 j/cm2 RF conducted and radiated emissions CISPR 11 Group 1, Class B - Maximum operating time per treatment is 30 minutes Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3...
Aesthetic Technology Limited 27. Labelling 28. Basic User Approach Product Labelling conforms to PL-001 (Rev 8) – Dermalux® Product Labelling Specification. The diagrams to the left demonstrate how the device should be set up and positioned around the users face. This is for illustrative purposes 28.1 Symbols and Product Labelling...
Aesthetic Technology Limited 29. System Warranty Under normal use this product is guaranteed for 2 years after its original purchase date The Dermalux® Flex MD warranty does not cover damage caused by the following: against manufacturing defects in materials or workmanship. •...
If all cable connections are secure, turn the device off at the mains socket and leave for 30 seconds. Turn on again. If the device continues to fail, contact Aesthetic Technology Ltd or your local Dermalux representative. See contact details on page 44.
The Controller button is illuminated but the LED’s on the Array do not come on. Aesthetic Technology Ltd declares that the Dermalux® Flex MD has been made to all relevant standards to its current market at the date of sale. The business reserves the right Contact Aesthetic Technology Ltd or your local Dermalux representative.
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