DermLiTe DL5 3Gen Dermatoscope Instructions
- June 12, 2024
- DermLiTe
Table of Contents
DL5 3Gen Dermatoscope
Instructions
DL5 3Gen Dermatoscope
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.
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 Termite
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: UV Light. Do not look directly at light.
CAUTION: This product contains magnets. Do not use in proximity of
pacemakers or other magnetically sensitive devices or items.
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.
Do not use this device during magnetic resonance imaging (MRI) or in an MRI
environment.
IMPORTANT: Before initial use, please charge the internal lithium ion
battery. See “Battery and Charging” for details.
DermLite DL5 is a smartphone-compatible pocket Dermatoscope with 10x
magnification for visualizing skin structures using variable polarized light
and UV illumination.
Hold your DermLite DL5, with the LEDs aimed in the direction of the lesion to
be examined, approximately 12 mm above the skin. Push the main button (M) to
turn on the device in cross-polarized mode. Look through the lens and move
the device closer or farther away from the skin to focus the image. For dermo
copy with skin contact, rotate the Focus Dial (FD) to extend the Spacer (S)
and focus the image.
Push and hold the main button (M) for about 1 second to turn off the device.
To save power, the unit automatically turns off after 3 minutes.
Variable Polarization
Tap the main button (M) to toggle between cross-polarized and non-polarized
illumination. Turn the main button to move through the range of 9 polarization
settings, from cross-polarized via non-polarized to parallel-polarized light.
The indicator strip (IS) reflects the current polarization status, whereas
“X” marks cross-polarized, “0” represents non-polarized, and “=” stands for
parallel polarization.
Pigment Boost®
While white light is active, tap (PB) to activate the orange-colored Pigment
Boost lighting in addition to white light. The indicator LED next to the PB
button (PB) will illuminate. Tap again to deactivate.
UV Mode
To visualize fluorescing structures, tap the UV button (UV) to activate LEDs
with a wavelength of 365 nm. The indicator LED next to the UV button (UV) will
illuminate. Tap the button again to return to the previously selected white-
light mode.
Torch
To illuminate larger skin areas or body cavities, tap the torch button (T) to
activate an ultra-bright white non-polarized LED. Turn the main button (M) to
adjust torch brightness.
Dermoscopic Brightness Adjustment
To adjust the brightness of the white Dermoscopic LEDs, hold the torch button
(T) and simultaneously turn the main button (M). While in UV or Pigment Boost
mode, push & hold the UV (or PB) button and turn the main button to adjust
the respective brightness. The indicator bar (IB) reflects the current
brightness level during the adjustment.
Eyepiece
For optimal viewing affix the included magnetic eyepiece (EP) at the extension
ring (ER).
Smartphone Dermoscopic
For Dermoscopic using a smartphone or tablet, securely fasten the Magneti
Connect clamp adapter (MCC) to your mobile device, ensuring concentric
alignment with its main camera. Attach your DL5 to the MCC ring. Prior to
taking images, extend the spacer (S) to the “0” position, and wipe the glass
contact plate (CP) clean.
Removing the Contact Plate
Turn the glass contact plate (CP) counterclockwise to detach, turn it
clockwise to reattach.
Ruler
The ruler (R) is magnetically attached to the handle.
Press down in the middle of the ruler and remove it to measure skin lesions.
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 3000mAh lithium ion battery,
which can only be purchased from DermLite or from an authorized DermLite
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 DermLite or an authorized DermLite
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 change the battery
(B), pull off the dial (D) by grabbing it at the fingernail notch, unscrew the
cover screw (CS) using the tool supplied with each DL5 replacement battery,
and sliding the battery cover (BC) off the device. Disconnect the small white
battery plug (BP) and remove the battery (B). Insert a new battery, reconnect
the battery plug, reattach the battery cover (BC), secure it with the cover
screw (CS), and push the dial (D) in until it snaps into place.
Charging Base
To charge your DL5 using the charging base, attach the smaller (USBC) end of
the supplied USB cable to the power port (PO) on the back of the charging base
(CB), and the larger (USB) end to any IEC 60950-1 compliant (5V) USB charger.
Place your DL5 into the charging base, with the contact plate (CP) facing
towards the charging base. The charging base is equipped with a USB charging
port (CP) which may be used to charge your smartphone or other DermLite
devices. The charging base may also be used for IceCap storage.
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: 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 DL5 (16 white LEDs, 4 UV LEDs, 4 Pigment Boost LEDs, 1 white Torch
LED, 32 mm lens system with 10x magnification, variable polarization system,
retractable spacer, removable faceplate with 10 mm reticle, steel ruler),
leather belt case, USB charging cable, charging base, magnetic eyepiece, MCC
mobile device adapter, plastic belt holster (H), 5 IceCaps, microfiber cloth.
Technical Description
Visit www.dermlite.com/technical or contact your local DermLite dealer.
| | |
---|---|---|---
Manufacturer| Catalog Number| Catalog 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
| Caution: UV Light. Do not look directly at light.
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@dermlite.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
©2022 by DermLite LLC | 25 Aug 2022 | DL5-1701A
References
- www.ca.gov | California State Portal
- The original polarized dermatoscope – your dermoscopy superpower.
- Warranty - DermLite
- lite.com
- lite.com
- P65Warnings.ca.gov
- The original polarized dermatoscope – your dermoscopy superpower.
- The original polarized dermatoscope – your dermoscopy superpower.
- Patents & Trademarks - DermLite
- Warranty - DermLite
- P65Warnings.ca.gov
- Dermatoscopio 3GEN DermLite DL5