Dermlite DL5 User manual

DL5
©2022 by DermLite LLC | 25 Aug 2022 | DL5-1701A
(English)
Instructions

FD
ER
IS
PBR
PP
USBC
UV
T
EP
CP
CI
USBC PO
USB
B
BP
BC
CB
DL5
S
IC
M
D
CS
PH00
MCC
MR
DL5
©2022 by DermLite LLC | 25 Aug 2022 | DL5-1701A
(English)

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 DermLite immediately and, if
required by local regulations, your national health authority.
CAUTION: Do not use the device in 󰘰re or explosive risk area (e.g. oxygen-rich environ-
ment).
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 repro-
ductive 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 stan-
dard 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 o󰘯ers 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 equip-
ment 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 equip-
ment 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 magni󰘰cation 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 dermoscopy 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 o󰘯 the device. To save power, the unit automatically turns o󰘯 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-polar-
ized via non-polarized to parallel-polarized light. The indicator strip (IS) re󰘱ects the current
polarization status, whereas “X” marks cross-polarized, “0” represents non-polarized, and
“=” stands for parallel polarization.
PigmentBoost®
While white light is active, tap (PB) to activate the orange-colored PigmentBoost 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 󰘱uorescing structures, tap the UV button (UV) to activate LEDs with a wave-
length 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 si-
multaneously turn the main button (M). While in UV or PigmentBoost mode, push & hold the
UV (or PB) button and turn the main button to adjust the respective brightness. The indicator
bar (IB) re󰘱ects the current brightness level during the adjustment.
Eyepiece
For optimal viewing a󰘲x the included magnetic eyepiece (EP) at the extension ring (ER).
Smartphone Dermoscopy
For dermoscopy using a smartphone or tablet, securely fasten the MagnetiConnect 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 o󰘯.
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 circum-
stances 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 o󰘯 the dial (D) by
grabbing it at the 󰘰ngernail notch, unscrew the cover screw (CS) using the tool supplied with
each DL5 replacement battery, and sliding the battery cover (BC) o󰘯 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 smart-
phone 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 modi󰘰cation of this equipment is allowed.
Your device is designed for trouble-free operation. Repairs shall be made only by quali󰘰ed
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 equip-
ment 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 PigmentBoost LEDs, 1 white Torch LED, 32
mm lens system with 10x magni󰘰cation, 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, micro󰘰ber cloth.
Technical Description
Visit www.dermlite.com/technical or contact your local DermLite dealer.
ENGLISH
©2022 by DermLite LLC | 25 Aug 2022 | DL5-1701A
(English)

DermLite LLC
31521 Rancho Viejo Rd Ste 104
San Juan Capistrano CA 92675 | USA
Tel. [phone] | Fax [phone]
[email protected] | www.dermlite.com
Patents & Trademarks: dermlite.com/patents
E. C. REP Ltd
5 Fitzwilliam Square East
Dublin 2, D02 R744, Ireland
Tel: [phone] | [email protected]
Explanation of Symbols
+50ºC
-20
80%
45
1060hPa
500
Manufacturer
Keep dry!
Type B applied part
Medical Device
Direct Current
European authorized representative
Caution: UV Light. Do not look directly at light.
Catalog Number
Serial Number
Date of Manufacture
Do not dispose as unsorted municipal waste
Temperature limits in ºC for storage and transport
Humidity limitation for storage and transport
Pressure limitation for storage and transport
Follow instructions for use
Product complies with European Medical Device Regulation (2017/745)
Caution: Federal law (USA) restricts this device to sale by, or on the order of, a licensed healthcare practitioner
©2022 by DermLite LLC | 25 Aug 2022 | DL5-1701A
(English)