Dermalux Tri-Wave User manual

Dermalux Triwave User Guide 2015
Dermalux®Tri-Wave User Guide

Dermalux Triwave User Guide 2015
The information in this document is proprietary to Aesthetic Technologies Ltd, and
supplied on the understanding that it shall be kept confidential to recipients and that it
shall not be reproduced and/or used for commercial purposes without the written
consent of Aesthetic Technologies Ltd.
Users of this device can obtain benefit from using it only if they read and
comprehend all information in the User Manual.
You must follow all the instructions in the User Manual.
Please feel free to contact us on our Customer Services number (see below) if you have any
comments about Dermalux®Tri-Wave LED systems or this User Guide.
Dermalux®is a registered trademark of;
Aesthetic Technology Ltd, Parkview House, Worrall Street, Congleton,
CW12 1DT United Kingdom
0845 689 1789
[email protected]
http://www.dermaluxled.com/

Dermalux Triwave User Guide 2015
TABLE OF CONTENTS
Section Header
Page
Intended use
4
Device Description
4, 5
Indications for use
6
Contraindications
6
Risks
7
Warnings and Precautions
8
Warnings associated with Photosensitivity
8
Common types of medications that may cause photosensitivity
9
Other substances not listed above can also cause photosensitivity.
10
Other warnings
11
Precautions
11
First time setup: Receiving
12
Assembly guide
13
Operating Information: Controls
16
Operating Information: Carrying out a Treatment
17
Switching the system ON/OFF
17
Stopping a treatment
18
Dermalux® Tri-Wave Operating System
18
Manual mode
18
Preprogrammed mode
20
Cleaning Instructions
22
Care and Maintenance
22
Disposal
22
Technical specification
23
General safety
23
Troubleshooting
24
Warranties
26

Dermalux Triwave User Guide 2015
Intended Use
The Dermalux®Tri-Wave Light Emitting Diode (LED) Phototherapy system emits low
level light in the Blue, Red and Near Infrared (NIR) region of the light spectrum and is
indicated for the treatment of mild to moderate acne vulgaris and periorbital wrinkles of
the face, musculoskeletal pain and general dermatological conditions.The Dermalux®
Tri-Wave LED system is intended to be used by physicians and suitable qualified
personnel.
Device Description
The Dermalux®Tri-Wave system consists of
1. Main Body
2. Power cable
3. Control panel
4. Lift arm and treatment head
power cable
5. LED Treatment head
6. Light Emitting Diodes (LED’s)
7. Lockable wheels
8. Patient Safety goggles
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Dermalux Triwave User Guide 2015
Device Description
The Dermalux®Tri-Wave system is a floor standing device whose purpose is to produce
an even, cool, narrow-band of light for the treatment of cosmetic and dermatological
conditions.
The system consists of a main body that contains the power supply (100-264Vac (47-
63Hz)) power switch and control panel and a treatment head that contains light emitting
diodes (LEDs). The main body is mounted on lockable wheels. The LEDs generate the
light.
The power supply is designed to power the internal electronics for the system and the
light emitting diodes. The power supply is connected to a suitable mains outlet via a 3
pin input socket and wall plug. The device is switched ON/OFF by a switch located on
the rear panel of the base unit.
The control panel contains a programmable timer and LCD display. Software allows the
operator to select the treatment wavelength and treatment time or select from a range of
pre-programmed treatment settings. The control panel also allows the operator to
position the treatment head.
The light is generated by light emitting diodes which are contained within a treatment
head. The treatment head is connected to the main body by a lift arm. The lift arm
allows the operator to correctly position the treatment head over the treatment area.
Safety goggles are supplied for patient comfort and safety.
The equipment is not used to make measurements of any sort, or to draw any
conclusions regarding the indication to treat. The equipment does not require checks on
the light output as the LEDs do not dim with age to any practical extent.

Dermalux Triwave User Guide 2015
Indications for Use
The Dermalux®Tri-Wave Light emitting diode (LED) system is intended to emit light in
the Blue, Red and Near Infrared (NIR) region of the light spectrum and is indicated for
the treatment of mild to moderate acne and periorbital wrinkles of the face,
musculoskeletal pain and general dermatological conditions.
Contraindications
DO NOT use Dermalux®Tri-Wave LED system to treat any other condition
that has not been listed in the ‘Indications for Use’ section. The Dermalux®
Tri-Wave LED system has not been tested for any other conditions and the risk is
unknown.
DO NOT use Dermalux®Tri-Wave LED system to treat pregnant women. The
Dermalux®Tri-Wave LED system has NOT been tested on pregnant women and
therefore the risk to the foetus or pregnant women is unknown.
DO NOT use Dermalux®Tri-Wave LED system to treat anyone who suffers from,
Lupus erythematosus, photosensitive eczema or Albinism. If you use the
Dermalux®Tri-Wave LED system to treat someone who suffers from Lupus
erythematosus, photosensitive eczema or Albinism you may cause a severe skin
reaction.
DO NOT use Dermalux®Tri-Wave LED system to treat anyone who suffers from
any photosensitive disorder (sensitisation to light). If you use the Dermalux®
Tri-Wave LED system to treat someone who suffers from a photosensitive
disorder you may cause a severe skin reaction.
DO NOT use Dermalux®Tri-Wave LED system to treat anyone who is taking any
medication that can cause photosensitivity. If you use the Dermalux®Tri-Wave
LED system to treat someone who is taking any medication that can causes
photosensitivity you may cause a severe skin reaction.
Please consult pages 8-10 for a list of common photosensitive medication.

Dermalux Triwave User Guide 2015
Risks
Dermalux®LED Phototherapy is safe and effective for all skin types. It is well tolerated
with very few reported side effects.
Known Risks
Immediately after treatment skin may feel warm and may appear red, due to the
increased blood circulation in your skin. Skin should return to normal with 1 to 2
hours.
Temporary headaches immediately following the light treatment. Headaches can
be treated with an appropriate pain killer and rehydration.

Dermalux Triwave User Guide 2015
Warning and Precautions
Warnings
ALWAYS ensure the client is wearing the safety goggles supplied before
operating the Dermalux®Tri-Wave LED system.
DO NOT use the Dermalux®Tri-Wave LED system without removing creams,
lotions or make-up BEFORE treatment. Some ingredients in these products
may cause light sensitisation or may reduce the effect of the treatment. If you use
the Dermalux®Tri-Wave LED system without removing these products you may
cause a severe skin reaction or you may lessen the effect of the treatment.
DO NOT use the Dermalux®Tri-Wave LED system in any way that is not
exactly as specified in these instructions for use. Use of the Dermalux®Tri-Wave
LED system other than exactly as specified in these instructions for use has not
been tested and the risk is unknown.
Warnings associated with Photosensitivity
Several medical conditions, medications, and chemicals can cause photosensitivity.
Photosensitivity may produce a rash of varying severity, which is known by the general
term, photodermatosis.
DO NOT use Dermalux®Tri-Wave LED system to treat anyone who suffers from,
Lupus erythematosus, photosensitive eczema or Albinism. If you use the
Dermalux®Tri-Wave LED system to treat someone who suffers from Lupus
erythematosus, photosensitive eczema or Albinism you may cause a severe skin
reaction.
Photosensitivity is a common side effect of various medications. These can
include certain antibiotics, chemotherapy drugs, and diuretics.
Below is a list of common types of medications that may cause photosensitivity.

Dermalux Triwave User Guide 2015
Common types of medications that may cause photosensitivity
Drug Type
Specific group or
common name
Comments
Antibiotics
Tetracyline group: Doxyclyline,
Oxytetracycline, Lymecycline etc
The treatment can be administered as
long as the medication has not been
taken in the last 5 days
Quinolone group: Ciprofloxacin,
Ofloxacin, Levofloxacin
The treatment can be administered as
long as the medication has not been
taken in the last 5 days
Sulfonamides:
sulfamethoxazole/trimethoprim
The treatment can be administered as
long as the medication has not been
taken in the last 5 days.
Non-steroidal anti-
inflammatory drugs (NSAIDs)
Naproxen, Celecoxib
The treatment can be administered as
long as the medication has not been
taken in the last 5 days
Diuretics
Furosemide, Bumetanide, Hydro-
chlorothiazide
The treatment can be administered as
long as the medication has not been
taken in the last 5 days
Retinoids
Tretinoin
Roaccutane/Accutane
Retinova, Retin A gel
The treatment can be administered as
long as the medication has not been
taken in the last 5 days.
Anti-arthritic
Azathioprine
The treatment can be administered as
long as the medication has not been
taken in the last 5 days.
Anti-Cancer drugs
Ledertrexate/Methotrexate
The treatment can be administered as
long as the medication has not been
taken in the last 5 days.
Antifungals
Terbinafine, Itraconazole,
Voriconazole, Griseofulvin
(Grisovin)
The treatment can be administered as
long as the medication has not been
taken in the last 5 days.
HMG-CoA reductase inhibitors
Statins (atorvastatin, fluvastatin,
lovastatin, pravastatin, simvastatin)
The treatment can still be
administered as long as the patient
reports no increased sensitivity to sun
since commencing statins
Anti-Psychotic
Chlorpromazines: Thorazine
Sonazine
The treatment can be administered as
long as the medication has not been
taken in the last 5 days.
Anti Arrythmic drugs
Codarone, Aratac, chlorpromazine
Exposure to light at far UV can cause
the skin to grey. At discretion of
practitioner. Treatment can be
administered as long as the
medication has not been taken in the
last 8 days.

Dermalux Triwave User Guide 2015
Drug Type
Specific group or
common name
Comments
Anti-inflammatory (topical)
Ketoprofen, Oruvail
Do not apply LED treatment directly
over gel. Can cause phototoxic
reaction if light is applied directly over
the gel.
Epidermal growth factor
receptor inhibitors (treatment
for lung cancer)
Cetuximab, panitumumab,
erlotinib, gefitinib, lapatinib,
vandetanib
Consult a physician before
commencing a course of Dermalux®
Anti-arthritic
Ridaura, Gold 50
If yes the treatment cannot be
administered
Other substances not listed above can also cause
photosensitivity.
Common examples of these substances include:
St John's Wort, anti-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).

Dermalux Triwave User Guide 2015
Other Warnings
To reduce the risk of injury or electrical shock
DO NOT position the treatment head less than the recommended distance from
the treatment area. Over extension of the lift arm may cause temporary
disconnection of the treatment head.
NEVER use the Dermalux®Tri-Wave LED system near water or where water can
be spilt onto the equipment.
NEVER use the Dermalux®Tri-Wave LED system if you think any part of the
equipment may have come into contact with water.
DO NOT attempt to modify the Dermalux®Tri-Wave LED system in any way.
Modifying the Dermalux®Tri-Wave LED system in any way could cause an
electric shock when the system is used again. The Dermalux®Tri-Wave LED
system contains no serviceable parts.
DO NOT use the Dermalux®Tri-Wave LED system if the LED treatment head,
control panel, main body or Power supply cable is damaged in any way.
Take care when using the LED treatment head positioning function.
Precautions
Before use with the device switched off, check the Dermalux®Tri-Wave LED
system, LED treatment head, control panel, main body and Power supply cable
for signs of physical damage.
Store the Dermalux®Tri-Wave LED system at room temperature in dry
conditions.
The entire surface of the Dermalux®Tri-Wave LED system may be cleaned by
following the cleaning instructions on page 20.
Do not use any other cleansing products other than those stated in the user
guide. Use of other cleansing products may damage the Dermalux®Tri-Wave
LED system.

Dermalux Triwave User Guide 2015
First Time Setup
1. Inspect the exterior of the shipping container for any damage which may have
occurred during transit.
2. Open the shipping container and carefully remove the individual components.
3. Inspect the system for any visual damage that may have been caused by
shipping.
4. Ensure that the following individual parts are present.
1. Dermalux®LED Treatment Head
2. Dermalux®Base Unit
3. Locking Bolt / Head Connector
4. Dermalux®Neck section
5. Power Cable
6. Client Goggles
7. 3mm Hex key and 17mm socket spanner
8. Dermalux®TRI-WAVE User Manual
If the any individual components are missing or damaged, please contact
Aesthetic Technologies Ltd or your local representative.
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Dermalux Triwave User Guide 2015
Assembly Guide
Follow the step by step First time set up guide to assemble the
Dermalux®Tri-Wave LED system.
You will require the following tools supplied with the Dermalux®Tri-Wave LED system.
1. 3mm Hex key
2. 17mm socket spanner

Dermalux Triwave User Guide 2015
First Time Setup
Follow the step by step guide to assemble your Dermalux®Tri-Wave LED
system.
STEP 1. Connecting the Neck section to the Base unit.
DO NOT Plug the Dermalux®Tri-Wave LED system into a wall socket
until Steps 1 - 2 (below) are completed. Plugging the Dermalux®LED
system into a wall socket before Steps 1 - 2 (below) are completed may
expose you to dangerous voltages or other risks.
1. Stand the Base unit upright and lock the wheels by pressing down on the locking
flange.
2. Remove rear panel from the Base Unit by unscrewing the 10
3mm Hex screws that secure the panel.
3. Remove the base panel from the neck section by unscrewing the
3mm Hex screws that secure the panel.
4. Align the neck section on top of the base unit. Using the 17mm
spanner, secure the neck section to the base unit from the inside
with the 4 x 17mm nuts provided.
5. Take the white cable from the base unit that has a 4 pin end
connector and feed it up the neck section and out of the hole in
under panel of the top of the neck section.
6. Take the black cable from the neck section that has a 2 pin end
connector and connect this to the black power supply unit in the
Base Unit.
7. Replace the base panel of the neck section and secure with the
3mm Hex screws provided.
8. Replace the rear panel of the Base Unit and secure with the
3mm Hex screws provided (10).

Dermalux Triwave User Guide 2015
STEP 2. Connecting the LED Treatment Head
9. Connect the LED treatment head to the height control arm.
10.Align the holes in LED head and height
control arm.
11.Secure with the black locking bolt.
12.Attach the white cable to the LED treatment head with
the 4 pin connector.
STEP 3. Connecting the Dermalux®Tri-Wave LED system to the mains
13.Plug the black Power Cable into the 3 pin input socket in the rear of the Base unit
14.Plug the Power Cable into a suitable wall socket.

Dermalux Triwave User Guide 2015
Operating Information
Controls
The control panel contains a programmable timer and LCD display and allows the
operator to control the position of the treatment head.
1. DISPLAY shows current information in programme and treatment modes
2. MENU pages through menu screen, used to confirm display prompts
3. UP & DOWN ARROW scrolls though the menu or allows you to toggle between
settings in the Manual Mode
4. ENTER confirms the screen prompt
5. LIFT adjusts the position of the LED treatment head up and down by
moving the Lift arm up or down. Press the button up to raise the LED treatment
head or down to lower the LED treatment head.
6. START/STOP activates or stops a treatment.
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Dermalux Triwave User Guide 2015
Carrying out a Treatment
Treatment Regime
A course of Dermalux®Tri-Wave treatments consists of 6 to 10, 20 minute treatment
sessions. The recommended frequency based on 6 to 10 sessions is 2 Dermalux®
treatments a week for 3 to 5 weeks.
A 24 hour time period between treatments is generally recommended
Always ensure the client is wearing the safety goggles supplied before
operating the Dermalux®Tri-Wave LED system.
Switching the System ON/OFF
1. To switch the Dermalux®Tri-Wave system ON, plug the 3 pin input plug into the
rear of the base unit. Insert the other end of the plug into a suitable grounded
wall socket.
2. Press the ON/OFF switch located on the rear panel of the base unit. The switch
will illuminate to indicate that the device is ON.
3. The display will illuminate showing the software
version and the device’s serial number.
4. The home screen is displayed showing program
options.
5. To switch the device OFF, press the ON/OFF
switch to OFF. The display on the Base unit will turn OFF.

Dermalux Triwave User Guide 2015
Stopping a Treatment
To STOP a treatment press the START/STOP button. The LEDs will switch OFF and
the timer will display the treatment summary indicating wavelengths delivered and the
treatment time for each wavelength.
Dermalux®Tri-Wave Operating System
Dermalux® Tri-Wave software allows the user to select either
i. Treatment parameters such as wavelength and treatment time (Manual mode).
OR
ii. Preset treatment programs (Pre-programmed Mode).
i. Manual Mode
Activating the Dermalux®Tri-Wave System is a 3 step process.
STEP 1. Selecting the TREATMENT TIME and WAVELENGTHS
1. Using the UP/DOWN buttons, scroll through the menu of preprogrammed
treatments. Use PAGE to jump to the next screen.
2. Select Manual from the treatment options by pressing
the SELECT key.
3. The Manual mode screen will be displayed.
4. Use ENTER to toggle forward and ENTER to select the
wavelength
5. Use the UP/DOWN buttons to switch wavelengths
ON/OFF. Press ENTER to confirm.
6. Use UP/DOWN buttons to increase or decrease
treatment time (units of 1 minute). Press ENTER to
confirm.
7. Use MENU to toggle back.
8. Press ENTER to confirm selection.

Dermalux Triwave User Guide 2015
STEP 2. POSITIONING the LED Treatment Head
1. Using the LED head positioning buttons to position the treatment head.
2. Press the LED head positioning button to raise the LED treatment head or
down to lower the LED treatment head.
3. Position the LED treatment head 4 cm from the treatment area.
Do NOT position the treatment head less than the recommended distance
from the treatment area. Over extension of the lift arm may cause
temporary disconnection of the treatment head
STEP 3. ACTIVATING the Dermalux®Tri-Wave System
12.Press the START/STOP button, the selected LEDs will illuminate
13.The timer will count down in 1 minute intervals
showing the time remaining for each selected
wavelength.
When using Near Infrared (NIR) the NIR indicator diodes will illuminate
yellow. The NIR indicator diodes are positioned at the top of each LED
panel.
END of Treatment
14.At the end of the treatment the LEDs will switch OFF.
15.The display shows a treatment summary indicating
the wavelengths delivered and the treatment time for
each wavelength.
16.Using the LED head positioning button raise the
treatment head away from the treatment area.
17.Press the LED head positioning button up to raise the
LED treatment head away from the treatment area
18.Remove the client safety goggles.

Dermalux Triwave User Guide 2015
ii. Preprogrammed Mode
The Dermalux®Tri-Wave system has 11 preprogrammed treatment settings.
Indication
Blue
Red
NIR
Treatment
time
(minutes)
Notes
Skin Rejuvenation
20
Mild/Moderate Acne
20
Severe Acne
20
10minutes of Blue and NIR light, followed by
10 minutes of Blue, Red and NIR light
Pigmentation
20
Rosacea
20
10minutes of NIR only, followed by
10minutes of Red and NIR light
Acne Rosacea
20
Inflammatory Skin
20
Allergic Reactions
20
Anti-Ageing
Combined
20
Acne Combined
20
Post Treatment
20
Activating the Dermalux®Tri-Wave System is a 3 step process.
STEP 1. Selecting a Preprogrammed treatment setting
1. Using the UP/DOWN buttons, scroll through the menu of preprogrammed
treatments. Use PAGE to jump to the next screen.
2. Select the preprogrammed treatment option from the
list by pressing the Select key.
3. The Display will show the treatment selected and the
treatment time for each wavelength.
4. Use the Menu key to return to the Home screen