©2021 by 3Gen Inc. | 04 May 2021 | NL1-1701B
(English)
Instructions
Intended Use
This device is intended for medical purposes to illuminate body sur-
faces. 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 profession-
als.
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).
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 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 electro-
magnetic 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.
Nailio® turns DermLite® Foto X (sold separately) into a nail exam-
ination device and provides enhanced visualization 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 alignment pins
(AP) match up with their mating 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 - but-
tons 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 ex-
amination at various 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 compliant (5V) USB port. The Charge Indicator (CI) pulses
to indicate charging, with the number of pulsing LEDs correspond-
ing 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.
Battery and Charging
CAUTION: This device uses a special 3.7V 1400mAh lithium ion
battery, which can only be purchased 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.
To change the battery, contact 3Gen or your local 3Gen dealer.
Troubleshooting
Please check www.dermlite.com for the most current trouble-
shooting 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: 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.
The Nailio set includes:
Nailio examination device (1 polarized red LED), USB to USB-C
charging cable, 5 IceCap covers.
Technical Description
Visit www.dermlite.com/technical or contact your local 3Gen dealer.
ENGLISH
