Dermlite Lumio 2 User manual

DLU2
©2023 by DermLite LLC | 16 Jan 2023 | DLU2-1701E
(English)
Instructions

USBC
OC
CI
W
UV
UVI
AP
OS
BR
BI
DLU2
©2023 by DermLite LLC | 16 Jan 2023 | DLU2-1701E
(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 exam-
ination 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.
Caution: UV Light. Do not look directly at light.
CAUTION: This product contains magnets. Do not use in prox-
imity of pacemakers or other magnetically sensitive devices or
items.
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 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 toxici-
ty. 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
emissions characteristics of this equipment make it suitable for
use in industrial areas and hospitals (CISPR 11 class A). If it is
used in a residential environment (for which CISPR 11 class B
is normally required), this equipment might not o󰘯er adequate
protection to radio frequency communication services, and the
user might need to take mitigation measures, such as relocating
or re-orienting the 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 immu-
nity 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.
Lumio 2 is intended for skin examinations with magni󰘰cation,
polarized white light, and a range of UV light wavelengths.
Hold Lumio about 75-150 mm (3-6”) above the skin to be
examined. Press the left button (W) to power on the device in
polarized white light mode. Pressing the left button (W) again
– while the device is on – toggles between white light and the
most recently-used UV lighting mode. To choose between UV
light wavelengths, tap the (UV) button until the UV indicator
(UVI) corresponding with the desired wavelength illuminates.
Note that the “Wood” mode is a blend of UV wavelengths that
approximates the spectrum of a classic Wood’s lamp.
Choose from one of three brightness levels by pressing the
brightness button (BR). The selected brightness level corre-
sponds with the number of brightness indicators (BI) illuminated.
Look through the lens with your eye placed 100-150mm (4-6”)
above the device. Move the device closer or farther away from
the skin to obtain the desired image focus and 󰘰eld of view.
To turn o󰘯 the unit, push and hold any button about 1 second. In
order to save power, the device will turn o󰘯 automatically after
3 minutes.
OptiClip™ Accessory
Lumio 2 includes two magnetic accessories designed to opti-
cally enhance the examination. In order to increase the contrast
of 󰘱uorescent features during UV examinations, magnetically
attach the OptiClip (OC) labeled “495nm LONG PASS” at the
dual attachment points (AP). In order to increase the main
lens magni󰘰cation by an additional 2.5x, use the “+2.5x” clip.
One OptiClip may be stored in the handle’s recessed OptiClip
Storage (OS).
Battery and Charging
CAUTION: This device uses a special 3.7V 4000 mAh 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 Indica-
tor (CI) pulses to indicate charging, with the number of pulsing
LEDs corresponding with charge level. When charging is com-
plete, 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. To change the
battery, contact DermLite or your local DermLite 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 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 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.
The Lumio 2 set includes:
Lumio 2 scope (polarized white LEDs, 365nm LEDs, 385nm
LEDs, 405nm LEDs, 100mm 2.3x primary lens), 2.5x add-on
lens, 495nm add-on bandpass 󰘰lter, protective pouch, USB to
USB-C charging cable
Technical Description
Visit www.dermlite.com/technical or contact your local DermLite
dealer.
ENGLISH
©2023 by DermLite LLC | 16 Jan 2023 | DLU2-1701E
(English)

©2023 by DermLite LLC | 19 Jan 2023 | Patents/Trademarks: www.dermlite.com/patents
Instructions
+50ºC
-20
80%
45
1060hPa
500
Manufacturer
Keep dry!
Type B applied part
Medical Device
Direct Current
European authorized representative
Indicates the authorised representative in Switzerland
Caution: UV Light. Do not look directly at light.
On/O󰘯 Button
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
©2023 by DermLite LLC | 16 Jan 2023 | DLU2-1701E
(English)
DermLite LLC 31521 Rancho Viejo Rd Ste 104
San Juan Capistrano CA 92675 | USA
Tel. [phone] | Fax [phone]
[email protected] | www.dermlite.com
E. C. REP Ltd
5 Fitzwilliam Square East,
Dublin 2, D02 R744, Ireland
Tel: [phone]
Email: [email protected]
CompLife Swiss s.a.
Via Luganetto 4
6962 Viganello (TI)
Responsible Person Limited
Summit House, 4-5 Mitchell Street
Edinburgh, EH6 7BD Scotland