Marking - Interacoustics Affinity 2.0 Manual De Instrucciones

2.2 Marking

The following symbols can be found on the instrument, accessories or packaging:
Symbol
0123
REF
I
O
Affinity2.0 – 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 indicates that Interacoustics A/S meets the requirements of Annex II of
the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No.
0123, has approved the quality system
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
Transport and storage temperature range
Transport and storage humidity limitations
Page 8