kaWe QM-1-101H Dermatoscope User Manual
- June 3, 2024
- KaWe
Table of Contents
MEDIZINTECHNIK
seit 1890
Dermatoskope
QM-1-101H
User’s Manual
QM-1-101H Dermatoscope
Contact disk with scale setting for dermatoscopes Ø 25 mm
Operation of KaWe EUROLIGHT D30 2.5 V and 3.5 V dermatoscopes:
Dear buyer! Thank you for choosing a KaWe product.
Our products are known for high quality and durability.
This KaWe device complies with the provisions of Directive EU
2017/745(European Directive on Medical Devices), whereby it is classified as a
medical product of class1.
Please carefully consider this instruction and read all the provisions
prior to use. Follow the maintenance recommendations.
Prior to use, please carefully consider the maintenance procedure.
Application: Only qualified medical professionals can use the
dermatoscope.
Group of patients with indications for use:
People of any age, male and female, requiring an examination of skin surface
structures.
Purpose: KaWe dermatoscope is designed for visual examination of body
surface. It zooms skin surface structures almost ten-fold, and with a halogen
lamp lights the area in question. The mechanism is analogous to microscopic
examination in reflected right (epiluminescence microscopy).
Dermatoscopy is aimed at precise examination of skin pigment changes in
everyday practice, specifically, within early detection of malignant melanoma.
Skin reflexes are suppressed by a special dermatoscopic moisturizing gel (KaWe
Derma-Gel), skin color changes are localized and detected more efficiently.
Contact lens scale allows esta-blishing the sizes of changes.
The device is designed only for skin surface examination.
Dermatoskope:
- KaWe EUROLIGHT D30 2.5 V dermatoscope
- KaWe PICCOLIGHT D 2.5 V dermatoscope
- KaWe EUROLIGHT D30 LED 3.5 V dermatoscope
Maintenance of KaWe EUROLIGHT D30 2.5 V and 3.5 V dermatoscopes: For proper
functioning, use standard KaWe 2.5 V handles with two KaWe 2.5 V or 3.5 V “C”
or Baby 1.5 V rechargeable batteries. Put them on and fix the device’s head.
To switch the device on, press and turn to the left a white plastic button on
the rotary switch. Variable resistor allows quick brightness regulation
(0=off, 1=max. brightness).
To switch the device off, turn the button the other way back to reference
position (switching off movement).
To replace the battery or rechargeable battery, open the lower cover.
To charge handles with rechargeable batteries, take off the plastic cover and
connect withKaWe MedCharge 4000 charging device.
To charge KaWe EUROLIGHT D30 LED 3.5 V, unscrew two connecting parts of the
handle and put the lower part of the handle with the mains plug into the
socket.
(ATTENTION: 3.5 V version is compatible with KaWe 3.5 V rechargeable batteries
only).
Remove the investigation head by lowering the throwon insert.
ATTENTION: Follow additional maintenance recommendations to make the service life of the rechargeable batteries longer.
Maintenance of KaWe PICCOLIGHT: Proper functioning is provided by KaWe
PICCOLIGHT handles with 2 batteries (“АА”-Mignon 1.5 V). To switch the device
on/off, use a sliding switch. To switch the device on using a sliding switch,
move it towards the dermatoscope’s head. To switch the device off, move the
sliding switch in reverse direction, to reference position. To replace the
battery and lamp, unscrew the head of KaWe PICCOLIGHT.
Time of application: The devices are designed for periodic use, maximum
operation time totals 1 minute. There shall be 10-minute pauses between the
applications.
Lamp replacement of KaWe PICCOLIGHT: For proper light functioning and
quality, use only original KaWe lamps. Unscrew the head of the dermatoscope
from the handle and remove the lamp. Clean the glass bulb of the new lamp with
alcohol-containing cloth. The glass bulb shall be clean and free from
fingerprints (grease spots). Put the lamp all the way into its groove in the
side pin. Then screw the investigation head back to the handle.
Lamp replacement of KaWe EUROLIGHT: For proper light functioning and
quality, use only original KaWe lamps. Unlatch the head of the dermatoscope
from the handle and remove the lamp. Now repeat the steps above in the section
on replacing KaWe PICCOLIGHT lamp. The glass bulb shall be clean and free from
fingerprints (grease spots). Put the lamp all the way in.
Handling: Put special moisturizing KaWe Derma-Gel dermatoscope gel on the skin
area of interest. Turn the light on and set the contact lens on skin without
excessive pressing.
Even lighting will cover the skin area with large examination diameter (25
mm).
Place the examined area in the center of the contact lens, if possible. Bring
the eyepiece as close to the eye as possible. With a free hand, turn the
focus ring until the image of the area of interest becomes sharp. Try looking
through the eyepiece without pressure on eye muscles (not accommodating them
for sharper view). Scales contact lens is designed to control the pigmented
skin changes. To examine raised or palpable skin areas (damages), dermatoscope
can be used without the contact lens. For a sharper view you can raise the
dermatoscope over the area of interest but not further than 5 mm.
Technical characteristics:
- Magnifier glass with 10x magnification
- Contact lens diameter: 25 mm
- Focusing / sharpness adjustment: -6…+3.5 diopter
- Halogen lamp aperture: 2.5 V (KaWe EUROLIGHT D30)
- Vacuum lamp aperture: 2.5 V (KaWe PICCOLIGHT D)
- LED lamp aperture: 3.5 V (KaWe EUROLIGHT D30 LED)
Additional directions, maintenance and storage: The device will serve for years with proper handling and storage.
Warranty: The warranty for the device totals two years from the date of
purchase with proper handling and following the operation manual (the warranty
does not cover lamps / rechargeable batteries). LED lamps are subject to five
years of guarantee from the date of purchase. If any issues arise or repair is
necessary, please contact your dealer.
Warnings: An error may cause extensive heat posing a threat of burn
injury. If the devices heats excessively, immediately turn the handle off.
Warnings: Do not put the dermatoscope in fluid and keep fluid off the
handle! The dermatoscope is not designed for surgery, so it is sufficient to
clean or disinfect it with surface alcohol-containing disinfectants.
Do not use abrasive cleaning agents! The dermatoscope shall not be sterilized.
Secondary treatment limitations: Secondary treatment has a minor effect on
these devices. The service life of the product is usually defined based on the
degree of wear and use-related damage.
Directives
Working area: Clean the surface with a disposable/paper cloth.
Environment conditions:
| temperature| relative air humidity
---|---|---
operation| +10°C to +35°C| max. 80 %
storage| -25°C to +70°C| max. 95 %
transport| -25°C to +70°C| max. 95 %
Transportation and storage: Store and transport dermatoscopes protecting
them from dust, moisture and dirt.
Preparation for cleaning: No special requirements.
Manual cleaning: Clean the dermatoscope external surface with a damp,
soft and lent-free cloth. Do not put the dermatoscope in fluid and keep body
off the handle! The dermatoscope is not designed for surgery, so it is
sufficient to clean it with surface alcohol-containing detergent.
Do not use abrasive cleaning agents!
The device shall not be sterilized. Clean the magnifying glass with a glass
detergent only.
Automatic cleaning: Automatic cleaning is impossible/unnecessary.
Disinfection: Clean the dermatoscope with surface alcohol-containing
disinfectants. Use a slightly damp cloth.
Sterilization: Scaled lens shall be sterilized in autoclave at 134 °C for
at least 3 minutes.
Additional information: When sterilizing several devices in autoclave, do
not exceed the maximum load indicated by the sterilizer manufacturer.
Maintenance: Remove or replace the damaged parts. If the device does not
work, do the following: 1.
Replace the batteries or rechargeable batteries and check whether they are
serviceable; 2. Replace the lamp and check whether it is serviceable; 3. Send
the device for repair.
Control and functional check: Check the smooth travel of moveable parts,
such as magnifying glass frame and plugs. Switch the device on.
All the instruments: Visually check for damages and wear. Keep all the
electric contacts clean.
Package: Separate zipped bag / fabric bag.
Disposal: Electric/electronic devices shall not be disposed together with
household waste! Dispose the device in accordance with the local regulations
at a special collection point.
General accessories: To find out more about these products, visit our
homepage: www.kawemed.com.
Manufacturer: KaWe
Manufacturer’s contact details: Dealer’s address or phone number:
+49-7141-68188-0.
Basic UDI-DI
4030155KaWe0103YV
Legend:
| Manufacturer
---|---
| Date of manufacture
****| Heed user’s manual
| Safety instructions or warning
| Separate collection of electrical / electronic equipment and rechargeable
batteries
| Item No.
| CE conformity label
| Applied part Type BF
| GOST-R certification of goods imported into Russia
| Store in dry conditions
| Temperature range limits
| Medical product
Instructions for service personnel and patients
In case of problems during the device use, it is necessary to immediately
contact the manufacturer and the competent authorities of the relevant member
state of the Union, in which the service personnel or the patient are located.
All information is without guarantee and subject to change.
KIRCHNER &
WILHELM GmbH + Co. KG
Eberhardstr. 56 • 71679 Asperg • Germany
Zentrale / Central offi ce
Fon: +49 -7141-68188-0
Fax: +49 -7141-68188-11
Email: info@kawemed.de
Internet: www.kawemed.com
QM-1-101H / B-26790 / 2021-04