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医療機器 3Gen DermLite II FLUIDのPDF 取扱説明書をオンラインで閲覧またはダウンロードできます。3Gen DermLite II FLUID 13 ページ。
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English
Instructions
CAUTION: Prior to using the DermLite, read these instruc-
tions 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 examina-
tion only.
The DermLite II Fluid is a pocket epiluminescence micros-
copy (PELM) device designed to view skin lesions with high
magnification and clarity.
A high-quality 25mm 10 x lens with superb color correc-
tion and reduced image distortion, 32 light- emitting diodes
(LEDs) with two intensity settings, a precise focal mecha-
nism, and a removable faceplate with 10 mm scale provide
for ideal skin microscopy.
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.
Place the DermLite II so that the faceplate rests on the
skin, and push the power button (A) at the left side of the
unit to activate the LEDs. Look through the lens with your
eye placed 1"( ~25mm) to 4" (~100mm) above the DermLite
II. Turn the focal dial (B) until the image appears in focus.
Five markings on the focal cylinder (C) aid in focusing: the
widest line in the middle indicates the "ideal" dial position
when the image is in focus for people with normal vision,
the outer lines each represent a deviation of 2 mm from the
"ideal" focal distance.
CAUTION: If the DermLite II Fluid 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 II Fluid 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)
For cleaning purposes, the DermLite II Fluid is equipped
with a removable faceplate, which can simply be screwed
off the front of the focal cylinder.
Light Intensity
A push on the button on the right side labeled "MODE" (F)
toggles between two light intensity settings. The first mode
activates 16 LEDs, and the second mode gives you twice as
much light with the activation of 32 LEDs.
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 re-
charged. 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 Derm-
Lite II Fluid 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 II Fluid uses a special lithium-ion battery,
which can only be purchased from 3Gen or from an autho-
rized 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 II Fluid to 3Gen for ser-
vicing, 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 II Fluid 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 II Fluid is designed for trouble-free opera-
tion. There are no adjustments to be made nor is any spe-
cial servicing required. Never attempt to open the device
for any reason.
Cleaning and Sterilization
The DermLite II Fluid 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 II Fluid features an innova-
tive optical microscopy system designed for superb clarity
and outstanding vision.
DermLite II Fluid components include:
•
thirty-two 3mm white LEDs
•
25 mm lens with 10x magnification
•
two light intensity settings (16 or 32 LEDs)
•
focusing and removable 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.