Dermalux FlexMD, User Manual

Page 1: ...USER GUIDE dermaluxled com PL 027 Rev 7 ...

Page 2: ...ing The System 18 17 Eye Safety 18 18 Receiving the Dermalux Flex MD 19 19 Using the Device 20 19 1 Assembly Guide 20 19 2 Setup and First Use 23 19 3 Startup Shutdown 24 19 4 Icons Explained 25 19 4 2 Detailed Software Walk Through 26 19 4 3 Red 633nm Treatment 28 19 4 4 Blue 415nm Treatment 29 19 4 5 NIR 830nm Treatment 30 19 4 6 Blue Red Treatment 31 19 4 7 Blue NIR Treatment 32 19 4 8 Red NIR ...

Page 3: ... equipment at time of purchase WARNING Risk of small parts keep out of reach of children Do not place objects in mouth Risk to inhalation or swallowing parts if damaged WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided as it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that ...

Page 4: ...supply is connected to a suitable mains outlet via a mains outlet and wall plug The device is switched ON OFF by a button located on the Controller The Dermalux Flex MD system is operated by a capacitive touch Controller which allows 7 treatment protocols to be selected via various wavelength combinations The light is generated by Light Emitting Diodes LED s which are contained within the flexible...

Page 5: ...tment NIR Activates Near Infra Red LED s for treatment Control Buttons BLUE RED NIR Play Initiates 30 minute treatment with pre selected LED wavelengths Table 1 Flex MD Control Buttons 3 Upon activation the timer screen will display the Dermalux logo followed by the Flex MD logo Select the required combination of wavelengths by pressing the buttons on the right side of the Controller See Flex MD T...

Page 6: ...ness Skin Tone Sensitive Skin Sensitive Skin Problem conditions Psoriasis Wound Healing Pain Refer to Flex MD Treatment Protocol manual PL 038 for a detailed explanation of protocols Indications for use include but are not limited to the following 8 Precautions and Contraindications The Dermalux LED Phototherapy treatment is safe and well tolerated however there are certain circumstances and medic...

Page 7: ...i perspirant antibacterial soaps artificial sweeteners naphthalene mothballs petroleum products brightening agents found in laundry detergent and cadmium sulphide a chemical injected into the skin during tattooing Photosensitivity may also be caused by the use of certain perfume applied in the treatment area Photosensitivity is a condition characterised by increased sensitivity to light particular...

Page 8: ...hydration 13 Known Risks Should injury occur as a result of using this device please seek medical advice and report as per Section 14 14 Adverse Event Reporting In the unlikely event of a product fault or an adverse response to the Dermalux Flex MD treatment please report the issue to Aesthetic Technology Ltd or your local Dermalux representative as soon as possible For all adverse reactions pleas...

Page 9: ... it Do not use the system if the LED Array has come into contact with water liquids Do not plug unplug or activate the system with wet hands Do not use the system in the presence of flammable liquids or gases Do not disassemble any parts from the system Opening or removing covers may expose the operator to dangerous voltages or other risks Incorrect reassembly may lead to an electric shock Do not ...

Page 10: ...ld be worn by the user when the device is in use Do not stare at operating LED Array May be harmful to the eyes Take note of the Warning label found on the inside of the Flex MD example listed below WARNING 18 Receiving the Dermalux Flex MD Inspect the system for any visual damage that may have been caused during transit Check warranty labels are intact at time of receiving the device If any of th...

Page 11: ...e device until instructed Do not use sharp objects to cut open the packaging as this may cause damage to the items inside Packaging All packaging has been specifically designed for transportation please dispose of all waste appropriately and only remove from the transportation packaging when necessary Labelling All labels are positioned as required under the document guidelines of PL 001 Disclaime...

Page 12: ...nto Base unit Connect the RJ11 cable to the Controller Connect the opposite end of the RJ11 connector to the Flex MD LED Array Connect the Power Supply to the Flex MD LED Array using the 5mm barrell jack When plugging in to the mains wall socket ensure the socket is off before plugging in Now switch the wall socket on Press the power button on the Controller to activate Display will illuminate wit...

Page 13: ...n page 25 Button Reference ID 1 19 4 Selecting a Program The following table identifies the universal icons that shall be used throughout the Controller display software The Flex MD device does not require a cool down period 19 4 1 Icons Name Icon Description Button Reference ID Power Turn device on and off 1 Blue Activates Blue LED s for treatment 2 Red Activates Red LED s for treatment 3 NIR Act...

Page 14: ...BLUE button is pressed the blue LED s will be selected for the treatment and the button will illuminate Blue To deselect blue LED s press BLUE button again 3 In the HOME screen if the RED button is pressed the red LED s will be selected for the treatment and the button will illuminate Red To deselect red LED s press RED button again 4 In the HOME screen if the NIR button is pressed the near infra ...

Page 15: ...MENT screen if the PLAY button is pressed the treatment is in progress or Paused Figure 9 Controller Overview for Red Treatment 19 4 4 Blue 415nm Treatment Button ID Function Requirement 2 Press the BLUE button to activate the blue LED s This is indicated by the button illuminating in blue 5 In the BLUE TREATMENT screen if the PLAY button is pressed the treatment is in progress or paused Navigatio...

Page 16: ...atment is in progress or paused Figure 11 Controller Overview for NIR Treatment 19 4 6 Blue Red Treatment Button ID Function Requirement 2 Press the BLUE button to activate the blue LED s This is indicated by the button illuminating in blue 3 Press the RED button to activate red LED s This is indicated by the button illuminating in red Navigation Home Blue Red Treatment 5 In the BLUE RED TREATMENT...

Page 17: ...TMENT screen if the PLAY button is pressed the treatment is in progress or paused Figure 13 Controller Overview for Blue NIR Treatment 19 4 8 Red NIR Treatment Button ID Function Requirement 3 Press the RED button to activate red LED s This is indicated by the button illuminating in red 4 Press the NIR button to activate near infra red LED s This is indicated by the button illuminating in yellow N...

Page 18: ...ed by using a clean dry microfibre cloth Please refrain from using any other cleansing products as these may damage the plastics and or electrical components If the Dermalux Flex MD system is used directly on the body the device must be thoroughly cleaned before use on another client The device will require no manufacturing maintenance or service on an annual basis The customer is expected to carr...

Page 19: ... Keep away from direct heat and sunlight The duty cycle for this product is continuous The product lifetime of this device is 2 years Aesthetic Technology Ltd provides a 2 year warranty to match the intended lifetime of the device Do NOT dispose of any part of the Dermalux Flex MD LED system at a domestic waste facility Seek waste disposal advice from your local council or consult Aesthetic Techno...

Page 20: ...ssions CISPR 11 Group 1 Class B Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Immunity tests Immunity Test Level Electrostatic Discharge ESD IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air Radiated RF EM fields IEC 61000 4 3 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000 4 3 380 ...

Page 21: ...r Operating Humidity Do not dispose of in general waste Table 12 Labelling Identification 28 Basic User Approach The diagrams to the left demonstrate how the device should be set up and positioned around the users face This is for illustrative purposes only The minimum distance between the LED Array and the user should be no less than 25mm The positioning of the LED Array mitigates unintended expo...

Page 22: ... to incorrect power sources Use with unauthorized accessories The warranty is VOID if the serial number and or associated labelling has been modified defaced or removed from the product Aesthetic Technology Ltd or its authorised distributors shall not be responsible for any incidental special or consequential damages resulting from the use of this product All implied warranties including but not l...

Page 23: ...ush together Switch the mains power back on and follow the User Guide for initial setup If the device continues to fail see further guidance below Switch the power off on the wall and disconnect the RJ11 Cable between the LED Array and the Controller Once removed reconnect ensuring it clicks into place and is secure Switch the power back on at the wall and follow the User Guide for initial setup I...

Page 24: ... on Contact Aesthetic Technology Ltd or your local Dermalux representative See contact details on page 44 The LED Array is not secure in the Base unit Ensure the LED Array is pushed all the way to the back of the Base Refer to initial Set Up guide Trouble removing the RJ11 cable from the Controller Press the plastic lever on the side of the connector and hold to release It is advised to leave this...

Page 25: ...Aesthetic Technology Ltd 211 Europa Boulevard Westbrook Warrington Cheshire WA5 7TN United Kingdom Tel 44 0 845 689 1789 Email info dermaluxled com dermaluxled com PL 027 Rev 7 ...