Dermlite Foto X User manual

DLFX
©2021 by 3Gen Inc. | 06 May 2021 | DLFX-1701B
(English)
Instructions

BB
RA
S
BS
FP
IC
CP USB-C
P
FM
CI
37
USB-A
DLFX
©2021 by 3Gen Inc. | 06 May 2021 | DLFX-1701B
(English)

Instructions
Intended Use
This device is intended for medical purposes to illuminate body surfac-
es. 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 󰘰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 equipment make it suitable for use in profes-
sional 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 because it could result in improper oper-
ation. If such use is necessary, this equipment and the other equip-
ment 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 Foto X is a polarized and non-polarized dermatoscope de-
signed for use with a wide range of cameras and mobile devices.
IceCap®
To support your infection control measures, snap one of the included
disposable IceCaps (IC) over the installed faceplate (FP). To remove
and dispose, simply pull it o󰘯.
Foto X may be attached to many cameras or smartphones via either
a magnetic or purely threaded connection. For use with MagnetiCon-
nect® adapters (sold separately), screw the Ring Adapter (RA) onto
the 37 mm thread (37). To create a threaded connection with your
camera, remove the Ring Adapter (RA) and thread the Foto X onto a
compatible camera or threaded camera adapter*.
Place the unit onto the skin, then push the Power button (P) to acti-
vate the light. Tapping the power button toggles between polarized
and non-polarized light. Move between four brightness levels via the
Brightness Buttons (BB). To adjust focus, turn the Spacer (S) as need-
ed; aligning the Focus Marks (FM) creates the ideal focal distance for
most photography.
To turn o󰘯 your DermLite, push and hold the Power button (P) for
about one second; the unit turns o󰘯 automatically after 3 minutes.
*Note that many cameras require the use of an additional adapter
made by the camera manufacturer or a photography supply company.
Removing the Spacer
The Spacer (S) may be removed by turning it counter-clockwise past a
slight resistance. When reattaching, make sure its three small protru-
sions match up with the Bayonet Slot (BS).
Removing the Faceplate
The Faceplate (FP) may simply be pulled o󰘯 the Spacer (S) by grab-
bing it at the 󰘰ngernail notches.
Battery and Charging
CAUTION: This device uses a special 3.7V 360mAh (2pcs) 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.
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 corresponding 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
3Gen or an authorized 3Gen dealer. To change the battery, contact
3Gen or your local 3Gen 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 3Gen dealer.
Care and Maintenance
CAUTION: No modi󰘰cation of this equipment is allowed.
Your device is designed for trouble-free operation. Repairs 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 protect-
ed from harmful chemicals. Do not use abrasive material on any part
of the equipment or immerse the device in liquid. Do not autoclave.
Warranty: 2 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 Foto X set includes:
Foto X scope (24 polarized & 8 non-polarized LEDs, 30mm 8x lens),
USB-A to USB-C charging cable, 5 IceCaps.
Technical Description
Visit www.dermlite.com/technical or contact your local 3Gen dealer.
ENGLISH
©2021 by 3Gen Inc. | 06 May 2021 | DLFX-1701B
(English)

3Gen Inc
31521 Rancho Viejo Road
San Juan Capistrano CA 92675 | USA
Tel. [phone] | Fax [phone]
[email protected] | www.dermlite.com
Patents & Trademarks: dermlite.com/patents
E. C. REP Ltd
5 Fitzwilliam Square East
Dublin 2, D02 R744, Ireland
Tel: [phone] | [email protected]
Explanation of Symbols
+50ºC
-20
80%
45
1060hPa
500
Manufacturer
Keep dry!
Type B applied part
Medical Device
Direct Current
European authorized representative
On/O󰘯 Button
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
©2021 by 3Gen Inc. | 06 May 2021 | DLFX-1701B
(English)