Markings - Interacoustics Sera Instructions For Use Manual

Markings

The following markings can be found on the instrument:
Symbol
0123
D-0113323-F – 2020/11
Sera™ - Instructions for Use - US
Explanation
Type B applied parts. According to IEC 60601-1.
Patient applied parts that are not conductive and can be immediately released
from the patient.
Applied part is Type BF according to the international standard IEC60601-1.
Caution.
Refer to instructions for use.
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 recovery and recycling. Failing
to do so may endanger the environment.
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.
Medical Device.
Serial number.
Date of manufacture.
Manufacturer.
Reference number.
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