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3Gen DermLite handyscope FFH2 Instructions Manual page 3

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  • ENGLISH, page 1
Instructions
CAUTION: Prior to using this de-
vice, read these instructions and
keep them in a safe place for future
reference. Rx only. This device is
designed for external examination
only within professional healthcare
facilities by medical professionals.
CAUTION: Do not use the device in
fire or explosive risk area (e.g. ox-
ygen-rich environment).
CAUTION: This product contains
glass. Dropping or mishandling de-
vice may cause glass breakage. Be
careful when handling broken glass;
glass may be very sharp.
WARNING: This product contains
magnets. Do not use in proximity of
pacemakers or other magnetically
sensitive devices or items.
NOTE: This product may interfere
with Qi wireless charging. Do not
charge your mobile device wireless-
ly while Ring or Wings are attached.
EMI Compatibility
This Product conforms to the elec-
tromagnet emissions standard IEC
60601-1-2: 2014.
The EMISSIONS characteristics of
this equipment make it suitable
for use in residential environment.
If interference to radio-frequency
communication services occurs, the
user might need to take mitigation
measures, such as relocating or re-
orienting the equipment.
Portable and mobile RF communi-
cations equipment can affect medi-
cal electrical equipment.
Use of this equipment adjacent to
or stacked with other equipment
should be avoided because 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 op-
erating normally.
Use of accessories, transducers and
cables other than those specified or
provided by the manufacturer of this
equipment could result in increased
electromagnetic emissions or de-
creased electromagnetic immunity
of this equipment and result in im-
proper operation.
This device complies with part 15 of
the FCC Rules. Operation is subject
to the following two conditions: (1)
This device may not cause harm-
ful interference, and (2) this device
must accept any interference re-
ceived, including interference that
may cause undesired operation.
Any changes/modifications to this
equipment not approved by 3Gen
could void the user's authority to op-
erate the equipment.
Directions for Use
Handyscope® is a smartphone
dermatoscope with polarized and
non-polarized light, clinical illumi-
nation and wireless functionality.
CAUTION: Do not look directly into
the LED light. Patients must close
their eyes during examinations.
CAUTION: Check the correct opera-
tion of the device before use! Do not
use the device if there are visible
signs of damage or the lights begin
to flash.
IMPORTANT: Before initial use,
please charge the internal lithium
ion battery. See "Battery & Charg-
ing" for details.
Handyscope may be attached to
most smartphones using the in-
cluded
adhesive-backed
steel
MagnetiConnect® Ring (R) or
Wings (W), depending on your
phone's camera position. For the
strongest hold on phones, espe-
cially those with a backside made
of glass, peel off the liner of the
Ring Guide (RG) or Wing Guide
(WG) in order to expose its adhe-
sive back and place it over the Ring
Film (RF) or Wing Films (WF).
Fig. 1: Handyscope may be at-
tached to most smartphones us-
ing the included adhesive-backed
steel MagnetiConnect® Ring (R)
placed at the 30 mm position. By
placing the 30 mm crosshairs (CH)
of the supplied Ring Guide (RG)
over your phone's camera, deter-
mine if your phone (or phone case)
has a flat, unobstructed area to at-
tach the steel Ring (R). If so, clean
the area with an isopropyl alcohol
wipe, remove the Ring's adhesive
film (AF) to expose its adhesive
and press the Ring firmly on your
phone while keeping the cross-
hairs aligned over your camera.
The RingGuide may now be re-
moved. Place Handyscope on the
Ring, aligning its lens with your
smartphone camera. The Handy-
scope will 'click' into place when
properly placed.
Fig. 2: The 40 mm Ring position
requires the RingAdapter (RA) with
its insert (I) placed in the 40 posi-
tion (Fig. 40; pull on the snap clo-
sure (S) to release the insert).
Fig. 3: Phones with cameras lo-
cated near the center may require
the use of MagnetiConnect Wings
(W) & WingAdapter (WA). To place
them correctly, clean the back of
your phone with an isopropyl al-
cohol wipe, place the Wing Guide's
(WG) crosshair over your phone's
camera, peel off the adhesive film
and press the Wings onto your
phone. Peel WingGuide off Wings.
Place the WingAdapter (WA) onto
the Wings, then attach Handys-
cope.
Fig. 4: Handyscope may also be
used with DermLite Connection Kits
(CK; sold separately). The adhesive
Ring or Wings are most easily re-
moved from your phone using den-
tal floss (not included).
Press the power button (P) to ac-
tivate the unit in polarized mode,
press it again to activate non-po-
larized light. For clinical illumina-
tion, press the power button a third
time. Push & hold the button for
about 1 second to turn off the unit.
In order to save power, the device
turns off automatically after 3 min-
utes.
Glass Faceplate
The snap-on glass faceplate (FP)
may be removed at the fingernail
notches (FN) and reinstalled with
the reticle scale (RS) in your pre-
ferred orientation.
Smartphone Pairing
To wirelessly pair Handyscope with
your smartphone, refer to a Handy-
scope-compatible app.
IceCap®
To support your infection control
measures, snap one of the includ-
ed disposable IceCaps (IC) over the
installed faceplate (FP).
Battery & Charging
CAUTION: This device uses a spe-
cialized 3.7V 670mAh lithium ion
battery, which can only be pur-
chased from 3Gen or from an autho-
rized 3Gen dealer. Do not under any
circumstances use another battery
other than the one designed for this
unit. Doing so could result in dam-
age to the 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 illumi-
nated. 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.
ENGLISH
When charging is complete, all four
indicator LEDs illuminate. From a
full charge, the device will allow
approximately 3-8 hours of opera-
tion, depending on the brightness
level used.
After years of use, you may wish to
replace the battery, which is only
available from 3Gen or an autho-
rized 3Gen dealer. To change the
battery, contact 3Gen or your local
3Gen dealer.
Troubleshooting
Please check www.dermlite.com
for the most current troubleshoot-
ing information. If your device re-
quires servicing, visit www. derm-
lite.com/service or contact your
local 3Gen dealer.
Care and Maintenance
Your device is designed for trouble-
free operation. Never attempt to
open the device for any reason. Re-
pairs shall be made only by quali-
fied service personnel.
Cleaning and Sterilization
The exterior of your device, except
the optical parts, may be wiped
clean with isopropyl alcohol (70%
vol.). The lens should be treated as
high-quality photographic equip-
ment and should be cleaned with
standard lens cleaning equipment
and protected from harmful chem-
icals. Do not use abrasive material
on any part of the equipment or im-
merse the device in liquid. Do not
autoclave.
The Handyscope set includes:
Handyscope smartphone dermato-
scope (3 polarized, 3 non-polarized
LEDs), 2 snap-in glass faceplates,
3 MagnetiConnect Rings, Ring
Guide, RingAdapter, 3 sets of Mag-
netiConnect Wings, Wing Guide,
WingAdapter, 3 sets of Ring/Wing
Film, Soft Carrying Case, lanyard,
IceCap sample supply, USB to
USB-C charging cable.
Warranty
10 years for parts and labor. The
rechargeable battery is warranted
for 1 year. Serial number and com-
pany information are located on
the unit.
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.

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