Important - DermLite hybrid m Instrucciones

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Instructions
CAUTION: Prior to using the DermLite, read these instructions
and keep them in a safe place for future reference.
CAUTION: United States Federal Law restricts this device to
sale by or on the order of a physician.
CAUTION: The DermLite is designed for external examination
only.
Introduction
The DermLite hybrid m is a pocket epiluminescence
microscopy (PELM) device designed to view skin lesions
with high magnification and clarity.
Two sets of LEDs (light emitting diodes) can be activated
independently; one set of 24 LEDs provides glare-free,
cross-polarized light by canceling the reflected light
from the skin, whereas the other set of 8 LEDs provides
non-polarized light for traditional immersion fluid
dermoscopy. A high quality, 25 mm 10x lens with superb
color correction and reduced image distortion produces
an image rich in surface detail.
To facilitate the use of immersion fluids, and allow for
fixed digital imaging, the unit is equipped with a
retractable faceplate spacer.
Directions for Use
CAUTION: Do not look directly into the bright LED light.
Patients must close their eyes during facial
examinations.
IMPORTANT: Before initial use, please charge the internal
lithium ion battery for a minimum of 4 hours using the
charger provided.
Hold the DermLite hybrid so that the LEDs are aimed in the
direction of the lesion to be examined. Place the device
approximately 1" (~25mm) from the skin. Push and hold
the power button (A) at the left side of the unit for 2-
3 seconds to activate the LEDs.
Look through the lens with your eye placed 1"( ~25mm)
to 4" (~100mm) above the DermLite hybrid. Move the device
closer or further away from the lesion to obtain the
desired image focus. For oil immersion imaging, or for
camera use, rotate the spacer dial (B) so that the white
marker is at the 12 o'clock position. For fine focusing
within a range of +/- 1mm, simply rotate the dial to the
left or right between the 11 and 1 o'clock markers (C).
CAUTION: If the DermLite hybrid m is used for oil
immersion imaging, place the oil only on the skin and
then place the extended faceplate spacer on top of the
oil. Do not allow oil to contact the USB port, DC charging
port, or battery compartment
To attach the DermLite hybrid m to a camera, the
device is equipped with a 28mm thread (D). A simple
ring adapter (such as a 28-37mm stepping ring) may be
required to adapt the device to your camera of choice.
Please contact 3Gen or a photographic retailer for more
information.
Removable Faceplate (E)
The DermLite hybrid m is equipped with a removable
faceplate. To remove this piece, rotate the spacer dial
(B) to extend the spacer, and twist off the small ring in
the very front of the spacer.
Cross-Polarized & Non-Polarized Modes
The button located on the right side of the device labeled
'MODE' (F) lets you toggle between two sets of LEDs.
Each time the device is turned on, cross-polarized light
is automatically active. To enable the non-polarized mode
for immersion fluid dermoscopy, push the 'MODE' button
once. To toggle back to cross-polarized illumination,
push the same buttton again.
Rechargeable Battery
After a minimum 4-hour initial charge, the lithium-ion
battery provides up to 2 hours of continuous operation,
or enough power for imaging approximately 600 lesions
at 30 seconds per examination. Once the battery is
depleted, the unit will automatically shut off, and will
need to be recharged. Plug the charging cord into the
round DC charging port (G), and the red charging indicator
(H) will illuminate. Once the battery is fully charged, the
green indicator will light up (I). Optionally, you may use
a USB cable to charge the unit via the USB port (J).
CAUTION: When charging with a USB cable, the DermLite
II hybrid m must be connected only to the USB port of
a computer that complies with the IEC / EN 60950
standard to ensure continued compliance of the product
with the European Medical Device Directive. Refer to
the operator's manual provided with your computer to
ensure that the computer complies with the above
standard.
After approximately 1,000 charges, the battery's capacity
will diminish and the battery may need to be replaced.
To remove the battery door (K), push down on the two
ovals (L) with your thumbs and slide the battery door
back. Disconnect the small white battery plug, and
remove the battery. Insert a new battery and reconnect
the battery plug. Replace the battery door securely on
the device.
The DermLite hybrid m uses a special lithium-ion
battery, which can only be purchased from 3Gen or from
an authorized 3Gen dealer.
CAUTION: Do not under any circumstances use another
battery other than the one designed for this unit. Doing
so could result in damage to the unit. Also, do not under
any circumstances use another charger other than the
one supplied with the unit.
Troubleshooting
Please check our website (www.DermLite.com) for the
most current troubleshooting information.
If you need to return the DermLite hybrid m to 3Gen
for servicing, please call 3Gen prior to returning the
device.
No Light
Fully recharge the battery and check again. If the condition
persists, send the unit to 3Gen for evaluation and/or
repair.
Weak Lighting
Recharge the battery.
LED Fails
The LEDs used in the DermLite hybrid m are designed
to last over 100,000 hours. If any of the 32 LEDs fail,
contact 3Gen for repair.
Mechanical Malfunction
Please contact 3Gen to arrange for service.
Care and Maintenance
The DermLite hybrid m is designed for trouble-free
operation. There are no adjustments to be made nor is
any special servicing required. Never attempt to open
the device for any reason.
Cleaning and Sterilization
The DermLite hybrid m body may be cleaned or
disinfected by wiping it with Isopropyl alcohol (70%
vol.). Do not use alcohol or disinfectants in the optical
areas of the unit. Do not use abrasive material on any
part of the equipment or immerse the device in liquid.
Do not autoclave.
Cleaning the Lens and the Polarizers
The lens and the polarizing filters should be treated as
high quality photographic equipment and should be
cleaned with standard lens cleaning equipment and
protected from harmful chemicals.
Specifications
The patent-pending DermLite hybrid m features an
innovative optical microscopy system designed for superb
clarity and outstanding vision.
DermLite hybrid m components include:
• Thirty-two 3mm White LEDs
• 25mm Lens with 10x Magnification
• Cross-Polarized and Non-Polarized Illumination
• Retractable Faceplate Spacer with 10mm Scale
• Lithium-Ion Battery
Warranty
5 years for parts and labor.
Serial number and company information are located
inside the battery compartment.