©2021 by 3Gen Inc. | 04 May 2021 | DL100-1701B
(English)
Instructions
Intended Use
This device is intended for medical purposes to illumi-
nate 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 dam-
age.
CAUTION: Do not look directly into the LED light. Pa-
tients 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 regula-
tions, 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 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 be-
cause 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 provid-
ed 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 de-
vice. Otherwise, degradation of the performance of this
equipment could result.
The DermLite DL100 pocket dermatoscope is designed
for skin lesions examination with magnification and
cross-polarized light.
Hold the DermLite so that the LEDs are aimed in the
direction of the lesion to be examined. Place the Der-
mLite approximately 12 mm (1/2”) from the skin (Fig.
1). If necessary, use your fingers to maintain optimum
spacing or attach the included spacer. Press the power
button (Fig. 2) at the side of the unit to activate the
LEDs and hold it down as long as you need light. Look
through the lens and move the device closer or further
away from the lesion to obtain the desired image focus.
Replacing the Battery (Fig. 3)
To change the battery, squeeze the sides of the battery
cap and remove it and the battery. Insert a new battery
of the same type with the contacts facing forward, then
reattach the battery cap.
The DermLite uses a 2CR5 lithium battery, which may
be purchased from 3Gen, your 3Gen dealer or an elec-
tronic retailer.
Troubleshooting
Please check www.dermlite.com for the most current
troubleshooting information. If your device requires ser-
vicing, 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. Re-
pairs 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.
DermLite DL100 includes:
Eight 3 mm white LEDs, 10x lens, cross-polarizers,
2CR5 Lithium Battery, removable spacer
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
