English - 3Gen DermLite Handyscope Instructions Manual

Instructions
Intended Use
This device is intended for medical purposes to illuminate body surfaces. It is used for non-in-
vasive 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 fire 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: 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 characteristics 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 equip-
ment 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 3Gen 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 functionality. It may be attached to most smartphones & tab-
lets 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 670mAh 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 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: 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.
The Handyscope set includes:
Handyscope smartphone dermatoscope (3 polarized, 3 non-polarized LEDs), MagnetiCon-
nect® 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 3Gen dealer.

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