Marking - Interacoustics Affinity 2.0 Gebrauchsanweisung

2.2 Marking

The following symbols can be found on the instrument, accessories or packaging:
Symbol
0123
REF
I
O
Affinity2.0/Equinox2.0 – Instructions for Use - EN
Explanation
Type B applied parts
Patient applied parts that are not conductive and can be released immediately from
the patient
Follow instructions for use
WEEE (EU-directive)
This symbol indicates that when the end-user wishes to discard this product, it must
be sent to separate collection facilities for recycling
The CE-mark in combination with MD symbol indicates that Interacoustics A/S meets
the requirements of the Medical Device Regulation (EU) 2017/745 Annex I
Approval of the quality system is made by TÜV – identification no. 0123.
Medical Device.
Year of manufacture
Manufacturer
Serial number
Reference number
Indicates a component is intended for one use, or for use on a single patient during a
single procedure
On (Power: connection to the mains).
Off (Power: disconnection from the mains).
Functionel Ground
Keep dry
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