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Dermlite carbon DLC-1701C User manual

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DLC
©2022 by DermLite LLC | 01 Mar 2022 | DLC-1701C
(English)
Instructions
~0.5”-1.0”
(~12-25mm)
~0.5” (~12mm)
1
2
Cross-
Polarization
Surface
Polarization
3
DLC
©2022 by DermLite LLC | 01 Mar 2022 | DLC-1701C
(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 DermLite immediately and, if required by local
regulations, your national health authority.
CAUTION: Do not use the device in 󰘰re 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 o󰘯ers 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 carbon pocket dermatoscope is designed
for skin lesions examination with magni󰘰cation and
cross-polarized or linearly 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 󰘰ngers to maintain optimum
spacing or attach the included spacer. Press the dome-
shaped button (Fig. 2) at the side of the unit to activate
the cross-polarized LEDs and hold it down as long
as you need light. To see skin surface structures with
linearly polarized light, use the second button. 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 DermLite, your DermLite dealer or
an electronic 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 DermLite dealer.
Care and Maintenance
CAUTION: No modi󰘰cation of this equipment is allowed.
Your device is designed for trouble-free operation. Re-
pairs shall be made only by quali󰘰ed 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 carbon includes:
Sixteen 3 mm white LEDs, 10x lens, cross-polarization
and linear polarization, 2CR5 lithium battery, removable
spacer, protective case with lanyard
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
DermLite dealer.
ENGLISH
©2022 by DermLite LLC | 01 Mar 2022 | DLC-1701C
(English)
DermLite LLC
31521 Rancho Viejo Rd Ste 104
San Juan Capistrano CA 92675 | USA
Tel. +1-949-481-6384 | Fax +1-949-240-7492
[email protected] | www.dermlite.com
Patents & Trademarks: dermlite.com/patents
E. C. REP Ltd
5 Fitzwilliam Square East
Dublin 2, D02 R744, Ireland
Tel: +353 1 2 544 944 | [email protected]
Explanation of Symbols
+50ºC
-20
80%
45
1060hPa
500
Manufacturer
Keep dry!
Type B applied part
Medical Device
European authorized representative
Catalog Number
Serial Number
Date of Manufacture
Do not dispose as unsorted municipal waste
Temperature limits in ºC for storage and transport
Humidity limitation for storage and transport
Pressure limitation for storage and transport
Follow instructions for use
Product complies with European Medical Device Regulation (2017/745)
Caution: Federal law (USA) restricts this device to sale by, or on the order of, a licensed healthcare practitioner
©2022 by DermLite LLC | 01 Mar 2022 | DLC-1701C
(English)