PRAXISDIENST DermLite DL4 Instructions

: June 8, 2024
: PRAXISDIENST

Table of Contents

PRAXISDIENST DermLite DL4
Instructions
Battery and Charging
Troubleshooting
Care and Maintenance
Cleaning
Disposal
Technical Description
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

PRAXISDIENST DermLite DL4

PRAXISDIENST-DermLite-DL4-product-image

Instructions

PRAXISDIENST-DermLite-DL4-1
Intended Use

This device is intended for medical purposes to illuminate body surfaces. 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 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).

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 .P65Warn-ings.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 equip- ment 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.
DermLite DL4 is a smartphone-compatible pocket dermatoscope designed to view skin lesions using cross-polarized or non-polarized light and high magnification and clarity.
A high-quality 10x lens with superb color correction and reduced image distortion produces an image rich in surface detail.

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.
Hold your DermLite DL4, with the LEDs aimed in the direction of the lesion to be examined, approximately 25mm (1”) above the skin. Push the power button (P) to turn on the device or push the two mode buttons (POL & PB), located at the head, simultaneously. Look through the lens and move the device closer or farther away from the skin to focus the image. To toggle between non-polarized mode for immersion fluid dermoscopy and cross-polarized illumination, briefly push any button. Push and hold (POL) for about 1 second to toggle between two brightness levels.
For dermoscopy with skin contact, rotate the Focus Dial (FD) to extend the spacer (S) and focus the image. To turn off your DermLite, push the power button (P) for about 1 sec. or push the two mode buttons (POL & PB), located at the head, simultaneously. To save power, the unit automatically turns off after 3 minutes.

Photography
This DermLite may be connected with mobile devices or cameras using DermLite magnetic adapters (sold separately) which attach to the extension ring (ER). Prior to taking images, wipe the faceplate (FP) clean and extend the spacer (S) to the “0” position.
Removing the Faceplate The faceplate (FP) may be pulled off the Spacer (S) by grabbing it at the finger-nail notches.

PigmentBoost®
Press (PB) briefly to activate PigmentBoost lighting in addition to white light. To enter the exclusively orange PigmentBoost Plus mode, press the button (PB) for about 1 second; briefly press (PB) or (POL) to exit.

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 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 indi-cator 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.
After hundreds of charges, the battery’s capacity will be reduced to the point where it may be more convenient to replace the battery. To remove the battery (BT), remove the battery cap (BC) by unscrewing the set screw (SSC) using he wrench supplied with each DL4 replacement battery. Disconnect the small white battery plug (BP) and slide the battery (BT) out. Insert a new battery and reconnect the battery plug. Replace the battery cap (BC) and secure it with the set screw (SSC).

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.

This set includes:
DermLite (24 LEDs, 30 mm lens system with 10x magnification, cross-polarized and non-polarized illumination, retractable spacer, removable faceplate with 10 mm reticle), silicone sleeve, belt case, charging cable, 5 IceCaps.

Technical Description

Visit www.dermlite.com/technical or contact your local 3Gen dealer.

Manufacturer
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
Product complies with European Medical Device Regulation (2017/745)
Type B applied part
Temperature limits in ºC for storage and transport
Pressure limitation for storage and transport
Humidity limitation for storage and transport
Keep dry!
Caution: Federal law (USA) restricts this device to sale by, or on the order of, a licensed healthcare practitioner