©2021 by 3Gen Inc. | 04 May 2021 | DL1-1701B
(English)
Instructions
Intended Use
This device is intended for medical purposes to illuminate body sur-
faces. 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 profession-
als.
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.P65Warnings.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 equipment make it suitable for use in profes-
sional 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 electro-
magnetic 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 DL1 is a mobile device-compatible dermatoscope
designed to view skin lesions with high magnification and clarity.
Four LEDs provide bright, even illumination, and a cross-polarized
spacer provides a glare-free image by cancelling the reflected light
from the skin. A high quality, three-element lens configuration,
designed to provide excellent results with leading mobile devices,
offers superb color correction and reduced image distortion for
images rich in surface detail.
Your DL1 is equipped with a magnetic adapter called Magneti-
Connect® Clamp (“MCC”), designed for attaching DL1 to most
smartphones and tablets. To attach MCC, position the clamp (MC)
over the main camera, then secure it by tightening the knob (KN).
Attach the threaded magnetic ring and place DL1 on it.
With its cross-polarized Spacer (B) and glass contact plate (E)
installed, place DL1’s contact plate directly on the skin. Applying
an immersion fluid onto the skin may improve the image. Push the
power button (C) to activate the light; push it again to turn it off. To
conserve power, your DL1 is designed to automatically turn off after
2 minutes.
For non-polarized dermoscopy, remove the polarized Spacer with
your thumb, then slide the included non-polarized Spacer over the
device. Attaching the included cross-polarized Clip (H) turns your
DL1 into an ultra-compact dermatoscope that fits into any pocket.
Glass Contact Plate
The unit’s glass contact plate (E) may be removed for cleaning or
non-contact imaging by rotating the bayonet ring (D) counter-clock-
wise. Handle the glass faceplate with great care.
Troubleshooting
Please check www.dermlite.com for the most current trouble-
shooting 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.
Battery and Charging
CAUTION: This device uses a special 3.7V 180mAh lithium ion bat-
tery, 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.
Prior to using the DL1, connect the wider connector of the provided
USB cable to any IEC 60950-1 compliant (5V) USB port (e.g. of a
laptop, desktop computer, or Apple charger) and the other end to
the DL1 Micro USB charging port (CP). The charging indicator (G)
will illuminate red to indicate that the DL1 is being charged. When
fully charged, the indicator turns green and the device will allow
up to an hour of continuous operation. If less than 25% battery life
remains, the indicator blinks.
DermLite DL1 components include:
DL1 dermatoscope (four white LEDs, three-element lens, faceplate
with 10mm reticle, battery), cross-polarized spacer with contact
plate, non-polarized spacer, polarized clip, charging cable, Magnet-
iConnect Clamp adapter
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.
Technical Description
Visit www.dermlite.com/technical or contact your local 3Gen dealer.
ENGLISH
