Dermlite Foto II Pro User manual

DLF2P
©2021 by 3Gen Inc. | 06 May 2021 | DLF2P-1701E
(English)
Instructions

2
P
ZR
FR
X
BI
5
8x
SP
FP
4
=
=
ZL
AR
CP
3
FC
PH #1
Canon
(EF/EF-S)
Nikon
(F-MOUNT)
AP
1
SD
AR
®
DLF2P
©2021 by 3Gen Inc. | 06 May 2021 | DLF2P-1701E
(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).
CAUTION: This product contains magnets. Do not use in proximity of
pacemakers or other magnetically sensitive devices or items.
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 II Pro is a dermoscopy lens designed to let you capture
high-resolution dermoscopic images with any Canon or Nikon SLR.
Directions for Use (Fig. 1-5)
Fig 1. The device is ready to be used with Nikon SLR cameras. For
use with Canon cameras, detach the installed F-MOUNT adapter and
replace it with the EF-EF-S adapter, making sure the alignment pin
(AP) is seated in its mating hole.
Carefully place the device with the faceplate (FP) onto the skin. Fig.
2: To activate the unit in polarized mode, push on the X button. To
activate non-polarized illumination, push it again. You may change the
󰘰eld-of-view by rotating the zoom ring (ZR) to either the fully zoomed-
in or zoomed-out position; avoid a midrange zoom setting as this may
result in out-of-focus images. The numbers on the zoom ring indicate
image frame height in mm for both full-frame sensors as well as cam-
eras with a smaller sensor size.
The device captures images with a very shallow depth of 󰘰eld which
enables precise focusing on the area of interest. The focus ring’s (FR)
“0” mark has been factory-calibrated to result in sharp images in most
cases. To make 󰘰ne focus adjustments, activate the “Live View” mode
on your camera, if available, then digitally zoom in using your camera
controls while turning the focus ring (FR) one marking to the right or
left.
Fig. 3: By attaching the 󰘱ash sync cable (FC) as shown, the device will
automatically change polarization mode after each photo.
Fig. 4. Zoom lock (ZL): In order to achieve repeatability, you may lock
the zoom ring using the included hex key. Simply remove the adapter
ring (AR), turn the key as shown, then reattach the ring.
Fig. 5 The spacer (SP) and faceplate (FP) are attached magnetically
and may be easily removed for cleaning. To turn o󰘯 the unit, push and
hold the button for about 1 second.
Battery and Charging
CAUTION: This device uses a special 3.7V 1480mAh (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 battery indicator (CI). When the unit is
turned on and fully charged, the indicator lights up green; when less
than 20% of battery life remains, the indicator is orange while a red
glow shows that less than 10% of battery life remains. To charge your
device, connect the supplied Micro-USB to USB cable to the Charging
Port (CP) and any IEC 60950-1 compliant (5V) USB port. The battery
indicator glows red to indicate charging. When charging is complete, it
illuminates green. From a full charge, the device will allow approxi-
mately 2-4 hours of operation.
After years of use, you may wish to replace the battery, which is only
available 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.
DermLite Foto II Pro includes:
Foto II Pro unit with removable spacer and faceplate, USB cable,
Nikon and Canon adapter rings, 󰘱ash sync cable, international char-
ger.
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.
Technical Description
Visit www.dermlite.com/technical or contact your local 3Gen dealer.
ENGLISH
©2021 by 3Gen Inc. | 06 May 2021 | DLF2P-1701E
(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
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 | DLF2P-1701E
(English)