DermLiTe HUD2 Smartphone Home Dermatoscope User Manual

: June 3, 2024
: DermLiTe

Table of Contents

HUD2 Smartphone Home Dermatoscope
Instructions
References
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Smartphone Home Dermatoscope
User Manual

HUD2 Smartphone Home Dermatoscope

DermLiTe HUD2 Smartphone Home Dermatoscope - fig

Instructions

Intended Use
This device is intended for medical purposes to illuminate body surfaces. It is used for non-invasive visual examination of intact skin.
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 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 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 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.
IMPORTANT: Before initial use, please charge the internal lithium ion battery. See “Battery and Charging” for details.
HÜD is a dermatoscope with polarized light designed for smartphone photography of skin lesions.
DermLite HÜD fits on virtually any smartphone or tablet. For best results, remove your protective case from your smart- phone or tablet. Using the clip, attach the device so that it is centered over your smartphone’s main camera.
Photography
Once you have chosen a skin lesion to photograph, lightly moisten it and its surrounding skin with hand sanitizer or a similar liquid. This increases the translucency of the skin and improves the quality of the image. If there is a lot of hair, attach the cap (C). With HÜD attached to your smartphone, place it directly on the skin and push the power button (P) to turn on the light. Capture the image with your smartphone.

Battery and Charging
To conserve energy, this device is designed to automatically turn off after 3 minutes. The battery can be expected to supply power for about 5 three-minute sessions. If the device turns off prior to 3 minutes, it may need to be recharged. To charge your device, connect the supplied to USB cable to the Charging Port (CP) and any IEC 60950-1 compliant (5V) USB port. The Charge Indicator (CI) pulses while charging and remains illuminated when fully charged.

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: 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.
This set includes a DermLite dermatoscope, 2 caps, a microfiber pouch, and a USB to USB-C cable.
Technical Description
Visit www.dermlite.com/technical or contact your local DermLite dealer.

| Manufacturer
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| Catalog Number
| Serial Number
| Date of Manufacture
| Medical Device
| Direct Current
| Follow instructions for use
| Do not dispose as unsorted municipal waste
| European authorized representative
| On/Off Button
| Product complies with European Medical Device Regulation (2017/745)
| Type BF applied part
| Temperature limits in ºC for storage and transport
| Pressure limitation for storage and transport
| Humidity limitation for storage and transport
| Keep dry!

Patents/Trademarks: www.dermlite.com/patents
DermLite LLC 31521 Rancho Viejo Rd Ste 104
San Juan Capistrano CA 92675 | USA
Tel. +1-949-481-6384 | Fax +1-949-240-7492
info@3geninc.com | www.dermlite.com ** E. C. REP Ltd
5 Fitzwilliam Square East,
Dublin 2, D02 R744, Ireland
Tel: +353 1 2 544 944 Email:** info@ecrep.ie