English - Dermlite Nailio Manuel D'instructions

Instructions
Intended Use
This device is intended for medical pur-
poses to illuminate body surfaces. It is
used for non-invasive visual examination
of intact skin.
This battery-operated product is de-
signed for external examination only
within professional healthcare facilities
by medical professionals.
Check the correct operation of the de-
vice 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 DermLite imme-
diately and, if required by local regula-
tions, your national health authority.
CAUTION: Do not use the device in fire
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 Cali-
fornia 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 require-
ments 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 ade-
quate protection to radio communication
service. In the rare event of interference
to the radio communication service, the
user might need to take mitigation mea-
sures, such as relocating or re-orienting
equipment.
WARNING: Use of this equipment adja-
cent to or stacked with other equipment
should be avoided because it could re-
sult 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 manufac-
turer 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. Other-
wise, degradation of the performance of
this equipment could result.
Nailio® turns DermLite® Foto X (sold
separately) into a nail examination
device and provides enhanced visualiza-
tion using red LED light.
Place the Nailio Base (B) on a table or
another level work area. Attach Foto X to
Nailio, making sure Nailio's two align-
ment pins (AP) match up with their mat-
ing alignment holes on Foto X. Slip the
supplied IceCap® Cover (IC) over the
Base (B), ensuring its printed guideline
(GL) is parallel with Nailio's arm (A).
For best results, apply an immersion
fluid such as ultrasound gel on your
patient's nail. Place your patient's finger
or toe over the LED's circular window
(LED). Turn on Foto X (refer to Foto
X instructions for use), then press the
power button (P) to activate Nailio's red
LED. Look through the Foto X lens and
gently push down to make contact with
the nail. Focus Foto X, if needed. Push
the + or - buttons to choose between
Nailio's 5 brightness levels. Adjust Foto
X brightness as desired.
Tilt Nailio from side to side and/or rotate
your patient's nail for examination at var-
ious angles, ensuring the digit covers the
red LED at all times. To allow for visual
examination of the distal nail, Nailio may
even be swiveled 90º. Swivel friction
can be modified with a 2.5mm hex key
(not included) via Friction Adjustment
(FA). Press the power button to turn off
the red LED. In order to save power, the
device will turn off automatically after 3
minutes.
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 compli-
ant (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 illumi-
nate. After years of use, you may wish
to re-place the battery, which is only
available directly from DermLite or an
authorized DermLite dealer.
Battery and Charging
CAUTION: This device uses a special
3.7V 1400 mAh lithium ion battery,
which can only be purchased from Der-
mLite or from an authorized DermLite
dealer. Do not under any circumstances
use another battery other than the one
designed for this unit.
To change the battery, contact DermLite
or your local DermLite dealer.
Troubleshooting
Please check www.dermlite.com for the
most current troubleshooting informa-
tion. If your device requires servicing,
visit www.dermlite.com/service or con-
tact your local DermLite dealer.
Care and Maintenance
CAUTION: No modification of this equip-
ment 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: 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 separat-
ed for disposal and may not be disposed
of with general household waste. Please
observe local disposal regulations.
The Nailio set includes:
Nailio examination device (1 polarized
red LED), USB to USB-C charging ca-
ble, 5 IceCap covers.
Technical Description
Visit www.dermlite.com/technical or
contact your local DermLite dealer.

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