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Instructions
Intended Use
This device is intended for medical purposes to
illuminate body surfaces. It is used for non-inva-
sive 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, malfunction, or the device operates in a
manner not consistent with what is described in
this instructions for use.
CAUTION: Do not look directly into the LED light.
Patients must close their eyes during examina-
tions.
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 fire or
explosive risk area (e.g. oxygen-rich environ-
ment).
CAUTION: This product contains magnets. Do
not use in proximity of pacemakers or other
magnetically sensitive devices or items.
WARNING: Do not use this item with any Qi
wireless charging products. The metal parts may
cause extreme heat resulting in burns and/or
damage to your device.
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 reproduc-
tive 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 characteris-
tics of this equipment make it suitable for use in
professional healthcare environment as well as
residential environment (CISPR 11 Class B).
This equipment offers 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 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
provided 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 device. Otherwise, degradation of the
performance of this equipment could result.
This device complies with part 15 of the FCC
Rules. Operation is subject to the following two
conditions: (1) This device may not cause
harmful interference, and (2) this device must
accept any interference received, including
interference that may cause undesired operation.
Any changes/modifications to this equipment not
approved by DermLite could void the user's
authority to operate the equipment.
IMPORTANT: Before initial use, please charge
the internal lithium ion battery. See "Battery and
Charging" for details.
Directions for Use
DermLite handyscope® is a smartphone
dermatoscope with polarized and non-polarized
light, clinical illumination and wireless functional-
ity. It may be attached to most smartphones &
tablets using the included MagnetiConnect®
Clamp adapter (MCC). For certain mobile
devices with a backside not made of glass, the
included adhesive ring (R) adapter may be used.
Using the MagnetiConnect Clamp Adapter (Fig.
A)
Position the clamp (MC) over your smartphone's
main camera, then fasten it by tightening the
knob (KN). Attach the threaded magnetic ring
and place DermLite handyscope on it.
Using the Adhesive Ring (Fig. B)
If your device has a backside not made of glass,
you may use the adhesive Ring (R). Center the
30 mm crosshairs of the supplied Ring Applicator
(RA) over the camera and determine if your
smartphone or tablet computer (or its case) has
a flat, unobstructed area for placing the steel
Ring (R). If so, clean the area with the included
isopropyl alcohol wipe, remove the ring's
adhesive film (RF) to expose its adhesive and
press the Ring firmly on your device while
keeping the crosshairs aligned over your
camera. Remove the Ring Applicator. Place
Handyscope on the Ring, aligning its lens with
your smartphone camera. Handyscope will 'click'
into place when properly placed.
Using the DermLite Connection Kit (Fig. C)
Handyscope may also be used with DermLite
Connection Kits (CK), which are designed
specifically for each iPhone model and sold
separately.
Using DermLite handyscope
Press the power button (P) to activate the unit in
polarized mode, press it again to activate
non-polarized light. For clinical illumination,
press the power button a third time. For best
dermatoscopic results, contact the skin lesion
with the center of Handyscope's glass contact
plate (FP) and avoid using zoom. Push and hold
the button for about 1 second to turn off the unit.
In order to save power, the device turns off
automatically after 3 minutes.
Glass Faceplate
The snap-on glass faceplate (FP) may be
removed at the fingernail notches (FN).
Smartphone Pairing
To wirelessly pair Handyscope with your
smartphone, refer to a Handyscope-compatible
app.
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 off.
Battery and Charging
CAUTION: This device uses a special 3.7V 670
mAh lithium ion battery, which can only be
purchased from DermLite or from an authorized
DermLite dealer. Do not under any circumstanc-
es use another battery other than the one
designed for this unit.
After hundreds of uses the battery will deterio-
rate, which may result in reduced capacity and/or
lithium-ion cell expansion. Monitor signs of a
deteriorated battery which may include reduced
battery life, unexpected shutdowns, erratic
behavior, or sudden power loss. If observed,
stop use of the device and do not charge the
battery. Replace the battery and dispose of the
original in accordance with local regulations.
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 DermLite or an authorized DermLite
dealer. To change the battery, contact DermLite
or your local DermLite 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 DermLite
dealer.
Care and Maintenance
CAUTION: No modification of this equipment is
allowed.
Your device is designed for trouble-free
operation. Repairs shall be made only by
qualified 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.
Warranty: 5 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 regula-
tions.
The Handyscope set includes:
Handyscope smartphone dermatoscope (3 polar-
ized, 3 non-polarized LEDs), MagnetiConnect®
Clamp (MCC), 2 snap-in glass contact plates, 3
Ring Applicators with adhesive Ring, soft
carrying case, lanyard, IceCap sample supply,
USB to USB-C charging cable
Technical Description
Visit www.dermlite.com/technical or contact your
local DermLite dealer.
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