Standard List - VISIOMED EASYSCAN FTX3 Manuel D'utilisation

For temperature difference between storage area and measurement site, condition the
thermometer for about 30minutes in room temperature (measurement site).
* Failing to do so may cause inaccuracy.
Stop using the product should any pain occur.
* It is likely to damage the auditory canal.
It is not recommended for use the by people suffering with ear disease including external
otitis and tympanitis.
* Affected part is likely to worsen.
Don't use the product if ear is wet after swimming or bathing or other.
* It may damage the auditory canal.
Don't throw batteries into fire.
* Battery is likely to explode in fire.
- Don't use the product for other purposes.
- It is not a waterproof device. Clean gently only with damp cloth.
- It is forbidden to leave the product exposed to any chemical solvent, direct sunshine or
high temperature.
- Don't drop, tramp or impose any vibration or impact on the product.
- Don't use a mobile phone nearby when the thermometer is working.
- Handling of used battery, please respect relevant waste disposal laws.
- Remove the batteries if not in use for a long time period.
S
TANDARD LIST
This appliance conforms to the following standards
ISO 10993-1:2003
ISO 10993-5:1999
ISO 10993-10:2002 Biological evaluation of medical devices - Part 10: Tests for
EN 60601-1:1990
EN 60601-1-2:2001 Medical electrical equipment-Part 1-2: General requirements
EN 12470-5:2003
Visiomed – EasyScan – User Manual V.4-102008
R
ECOMMENDATIONS
Biological evaluation of medical devices - Part 1: Evaluation
and testing
Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity
irritation and delayed-type hypersensitivity
Medical electrical equipment -- Part 1: General requirements
for safety
for safety-Collateral
compatibility-Requirements and tests
Clinical thermometers -Part 5: Performance of infra-red ear
thermometers (with maximum device)
N
OTICE
standard: Electromagnetic
16/39