©2021 by 3Gen Inc. | 04 May 2021 | DL4W-1701D
(English)
Instructions
Intended Use
This device is intended for medical purposes to illuminate body surfaces. It is
used for non-invasive visual examination of intact skin.
This battery-operated product is designed for external examination only within
professional healthcare facilities by medical professionals.
Check the correct operation of the device before use! Do not use the device if
there are visible signs of damage.
CAUTION: Do not look directly into the LED light. Patients must close their eyes
during examinations.
In case of a serious incident with the use of this device, notify 3Gen immediately
and, if required by local regulations, your national health authority.
CAUTION: Do not use the device in fire or explosive risk area (e.g. oxygen-rich
environment).
WARNING: This product can expose you to chemicals including methylene
chloride and hexavalent chromium, which are known to the State of California to
cause cancer or reproductive toxicity. For more information go to www.P65Warn-
ings.ca.gov.
Electromagnetic Compatibility
This device complies with the EMC Emissions and Immunity level requirements
of the standard IEC 60601-1-2:2014. The emission characteristics of this equip-
ment make it suitable for use in professional healthcare environment as well as
residential environment (CISPR 11 Class B). This equipment offers adequate
protection to radio communication service. In the rare event of interference to the
radio communication service, the user might need to take mitigation measures,
such as relocating or re-orienting equipment.
WARNING: Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
WARNING: Use of accessories other than those provided by the manufacturer of
this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
WARNING: Portable RF transmitters should be used no closer than 30 cm (12
inches) to any part of the device. Otherwise, degradation of the performance of
this equipment could result.
IMPORTANT: Before initial use, please charge the internal lithium ion battery.
See “Battery and Charging” for details.
DermLite DL4 is a smartphone-compatible pocket dermatoscope designed to
view skin lesions using cross-polarized or non-polarized light and high magnifica
-
tion and clarity.
A high-quality 10x lens with superb color correction and reduced image distortion
produces an image rich in surface detail.
IceCap®
To support your infection control measures, snap one of the included disposable
IceCaps (IC) over the installed faceplate (FP). To remove and dispose, simply
pull it off.
Hold your DermLite DL4, with the LEDs aimed in the direction of the lesion to
be examined, approximately 25mm (1”) above the skin. Push the power button
(P) to turn on the device or push the two mode buttons (POL & PB), located at
the head, simultaneously. Look through the lens and move the device closer or
farther away from the skin to focus the image. To toggle between non-polarized
mode for immersion fluid dermoscopy and cross-polarized illumination, briefly
push any button. Push and hold (POL) for about 1 second to toggle between two
brightness levels.
For dermoscopy with skin contact, rotate the Focus Dial (FD) to extend the spac-
er (S) and focus the image. To turn off your DermLite, push the power button (P)
for about 1 sec. or push the two mode buttons (POL & PB), located at the head,
simultaneously. To save power, the unit automatically turns off after 3 minutes.
Photography
This DermLite may be connected with mobile devices or cameras using DermLite
magnetic adapters (sold separately) which attach to the extension ring (ER). Prior
to taking images, wipe the faceplate (FP) clean and extend the spacer (S) to the
“0” position.
Removing the Faceplate
The faceplate (FP) may be pulled off the Spacer (S) by grabbing it at the finger
-
nail notches.
Battery and Charging
CAUTION: This device uses a special 3.7V 1400mAh lithium ion battery, which
can only be purchased from 3Gen or from an authorized 3Gen dealer. Do not
under any circumstances use another battery other than the one designed for
this unit.
This device is equipped with a four-level Charge Indicator (CI). When the unit is
turned on and fully charged, all four LEDs light up. When less than 75% of battery
life remains, three LEDs are illuminated. If more than half the battery is drained,
two LEDs are on, while a single LED indicates that less than 25% of battery
capacity remains. To charge your device, connect the supplied USB-C to USB
cable to the Charging Port (CP) and any IEC 60950-1 compliant (5V) USB port.
The Charge Indicator (CI) pulses to indicate charging, with the number of pulsing
LEDs corresponding with charge level. When charging is complete, all four indi-
cator LEDs illuminate. After years of use, you may wish to re-place the battery,
which is only available directly from 3Gen or an authorized 3Gen dealer.
After hundreds of charges, the battery’s capacity will be reduced to the point
where it may be more convenient to replace the battery. To remove the battery
(BT), remove the battery cap (BC) by unscrewing the set screw (SSC) using
the wrench supplied with each DL4 replacement battery. Disconnect the small
white battery plug (BP) and slide the battery (BT) out. Insert a new battery and
reconnect the battery plug. Replace the battery cap (BC) and secure it with the
set screw (SSC).
Troubleshooting
Please check www.dermlite.com for the most current troubleshooting information.
If your device requires servicing, visit www.dermlite.com/service or contact your
local 3Gen dealer.
Care and Maintenance
CAUTION: No modification of this equipment is allowed.
Your device is designed for trouble-free operation. Repairs shall be made only by
qualified service personnel.
Cleaning
The exterior of your device, except the optical parts, may be wiped clean with
isopropyl alcohol (70% vol.) prior to use on a patient. The lens should be treated
as high-quality photographic equipment and should be cleaned with standard lens
cleaning equipment and protected from harmful chemicals. Do not use abrasive
material on any part of the equipment or immerse the device in liquid. Do not
autoclave.
Warranty: 10 years for parts and labor. The battery is warranted for 1 year.
Disposal
This device contains electronics and a lithium-ion battery that must be separated
for disposal and may not be disposed of with general household waste. Please
observe local disposal regulations.
This set includes:
DermLite (24 LEDs, 30 mm lens system with 10x magnification, cross-polarized
and non-polarized illumination, retractable spacer, removable faceplate with 10
mm reticle), silicone sleeve, belt case, charging cable, 5 IceCaps.
Technical Description
Visit www.dermlite.com/technical or contact your local 3Gen dealer.
ENGLISH