DermLite GL Manual Del Usuario página 3

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 pro-
fessional 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, malfunction, or the de-
vice operates in a manner not consistent
with what is described in this instructions
for use.
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 DermLite 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 Emis-
sions and Immunity level requirements of
the standard IEC 60601-1-2:2014. The
emission characteristics of this equipment
make it suitable for use in professional
healthcare environment as well as resi-
dential 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 adja-
cent 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 equip-
ment 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. Other-
wise, 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 GL is a smartphone-compat-
ible polarized light examination device
with 6x and 1.4x magnification.
Hold your DermLite GL so that the LEDs
are aimed at the skin. Position the device
~25-50mm above the skin and push the
Power button (P) to activate one group
of LEDs. To activate the other group of
LEDs for the other magnification lens,
simply push the Power button (P) again.
Look through the lens with your eye 25-
50mm above your DermLite. Move the
device closer or farther away from the
skin to obtain the desired image focus. To
turn off your DermLite, push and hold the
Power button (P) for about one second;
the unit turns off automatically after 3 min-
utes. To help you approximate the size
of a skin lesion, the device has a 40mm
scale (MM) debossed into its housing.
Cap
To protect the optical areas after use,
slide the cap (C) over your unit. During
use, the cap can be attached over the oth-
er tail end of your DermLite.
Photography
DermLite GL may be attached to mobile
devices using DermLite adapters (sold
separately). Prior to taking photos at
the higher (6x) magnification, attach the
Spacer (S), ensuring it aligns with the
notch (N).
Battery and Charging
CAUTION: This device uses a special
3.7V 1300 mAh lithium ion battery, which
can only be purchased from DermLite or
from an authorized DermLite dealer. Do
not under any circumstances use another
battery other than the one designed for
this unit.
After hundreds of uses the battery will
deteriorate, which may result in reduced
capacity and/or lithium-ion cell expansion.
Monitor signs of a deteriorated battery
which may include reduced battery life,
unexpected shutdowns, erratic behavior,
or sudden power loss. If observed, stop
use of the device and do not charge the
battery. Replace the battery and dispose
of the original in accordance with local
regulations.
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 cor-
responding with charge level. When
charging is complete, all four indicator
LEDs illuminate. After years of use, you
may wish to re-place the battery, which is
only available directly from DermLite or an
authorized DermLite dealer. To change
the battery, contact DermLite or your local
DermLite dealer.
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 DermLite dealer.
Care and Maintenance
CAUTION: No modification of this equip-
ment 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: 5 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.
The DermLite GL set includes:
GL scope (6 polarized LEDs in two
groups, 20mm 6x lens, 25mm 1.4x lens,
40mm debossed measuring scale), cap,
USB to USB-C charging cable, snap-on
spacer.
Technical Description
Visit www.dermlite.com/technical or con-
tact your local DermLite dealer.
ENGLISH