Disposal; Certification - Agu IHE3 Eaglet Mode D'emploi

13

DISPOSAL

The symbol on the product or its package means that this product does not
fall under the category of domestic waste.
• Proper disposal of the device will prevent adverse environmental and
human health effects.
• In order to protect the environment, the device must not be disposed of
together with domestic (household) waste. Disposal shall be provided in
accordance with local regulations.
• The device must be disposed of in accordance with the EU Directive
2012/19/EU WEEE (Waste Electrical and Electronic Equipment).
If you have any questions, please contact the local public utility responsible for
waste disposal.
14

CERTIFICATION

This product conforms to the provisions of the EU Medical Device Directive
(93/42/EEC). The following standards are applied to design and/or manufacture
of the products:
• ISO 80601-2-56
Medical electrical equipment – Part 2–56: Particular requirements for
basic safety and essential performance of clinical thermometers for body
temperature measurement;
• IEC/EN 60601-1
Medical electrical equipment – Part 1: General requirement for safety;
• IEC/EN 60601-1-2
Medical electrical equipment – Part 2: Collateral standard: Electromagnetic
compatibility – Requirements and tests.
This device is an adjusted mode clinical thermometer. The validated data for clini-
cal accuracy in each adjusted mode are.
This device is an adjusted mode clinical thermometer. The validated data for
clinical accuracy in each adjusted mode are:
group A1:
group A2:
group B:
group C:
Dcb – clinical bias, L
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Dcb=–0,01 °C, L =0,18, σ
A
Dcb=0,06 °C, L =0,22, σ
A
Dcb=–0,01 °C, L =0,20, σ
A
Dcb=–0,01 °C, L =0,18, σ
A
– limits of agreement, σ
A
=±0,08 °C;
r
=±0,08 °C;
r
=±0,07 °C;
r
=±0,07 °C.
r
– clinical repeatability.
r