Important; English - DermLite DL3N Instrucciones

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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 methy-
lene 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 re-
quirements of the standard IEC 60601-1-2:2014. The emission character-
istics of this equipment 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 oper-
ation. 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 man-
ufacturer 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 DL3N is a smartphone-compatible pocket dermatoscope
designed to view skin lesions using cross-polarized or non-polarized light
and high magnification and clarity.
A high-quality 10x lens with superb color correction and reduced image
distortion produces an image rich in surface detail.
Hold your DermLite DL3N so that the LEDs are aimed in the direction of
the lesion to be examined. Place the device approximately 25 mm (1")
from the skin. Push and hold the power button (A1) for approximately
1 second to activate cross-polarized mode. A quick tap of the button
toggles between polarized and non-polarized modes. The additional
PigmentBoost® illumination may be activated via the left button (A2).
Look through the lens with your eye placed about 25-100 mm (1-4")
above the lens. Move the device closer or further away from the skin to
focus. For dermoscopy with skin contact, extend the spacer by rotating
the Focus Dial (B). To turn off your DermLite, push & hold the power
button for about 1 second.
Removing the Spacer
Unscrew the Retaining Ring (B1) and rotate the Focus Dial (B) until the
Spacer (B2) drops.
To re-attach the Spacer, slip its three pins through the three notches (D)
and gently rotate the Focus Dial until the Spacer is being pulled back in.
Reattach the Retaining Ring.
Eyepiece
To reduce internal reflections and improve the contrast of the image,
attach the optional eyepiece onto the 28mm thread (E).
Photography
DermLite adapters for mobile devices and cameras (sold separately) are
designed to attach to the 28 mm thread (E). To accept DermLite magnet-
ic adapters, attach the included steel ring to the 28 mm thread. Prior to
taking images, wipe the Faceplate (F) clean and extend the Spacer to the
"0" position.
Battery and Charging
CAUTION: This device uses a special 3.7V 1250mAh 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.
Prior to using the DermLite, insert the 110V-220V power plug into an
electrical outlet and the other end into the back of the charging base. Set
the base on a level surface. Place the DermLite onto the base, and the
"3" illuminates red to indicate charging. When fully charged, the "3" turns
green and the device will allow up to 2 hours of continuous operation.
When less than 25% battery life remains, the "3" turns orange.
The battery's capacity diminishes after years of use. To replace the
battery, slide the rubber handle (G) back and completely off the device.
Disconnect the small white battery plug and remove the battery. Insert
a new battery and reconnect the battery plug. Slide the rubber handle
securely onto the device.
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 harm-
ful 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 house-
hold waste. Please observe local disposal regulations.
This set includes:
DermLite-Dermatoscope (28 LEDs, 25mm 10x lens, cross-polarized and
non-polarized illumination, PigmentBoost, retractable faceplate spacer
with 10mm reticule), charging base, leather sleeve, 28 mm eyepiece,
lanyard
Technical Description
Visit www.dermlite.com/technical or contact your local 3Gen dealer.

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