D-0004578-R – 2022/05 Page 8
Affinity2.0/Equinox2.0 - Instructions for Use - US
2.2 Marking
The f ollowing symbols can be found on the instrument, accessories, or packaging:
Type B applied parts
Patient applied parts that are not conductive and can be released immediately from
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 facilities f or recycling
0123
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
Manufacturer
Serial number
Reference number
Indicates a component is intended for one use, or f or use on a single patient during a
single procedure
I
On (Power: connection to the mains).
O
Off (Power: disconnection f rom the mains).
Functional Ground
Keep dry
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