Marking - Interacoustics Affinity2.0 Instructions For Use Manual

2.2 Marking

The f ollowing symbols can be f ound on the instrument, accessories, or packaging:
Symbol
0123
REF
I
O
D-0004578-R – 2022/05
Affinity2.0/Equinox2.0 - Instructions for Use - US
Explanation
Type B applied parts
Patient applied parts that are not conductive and can be released immediately f rom
the patient
Follow instructions f or use
WEEE (EU-directive)
This symbol indicates that when the end-user wishes to discard this product, it must
be sent to separate collection f acilities f or 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 – identif ication no. 0123.
Medical Device.
Year of manuf acture
Manuf acturer
Serial number
Ref erence number
Indicates a component is intended f or one use, or f or use on a single patient during a
single procedure
On (Power: connection to the mains).
Of f (Power: disconnection f rom the mains).
Functional Ground
Keep dry
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