Interacoustics Sera - Markings

D-0112389-I – 2022/04
Sera™ - Instructions for Use - EN Page 10
3.2 Markings
The following markings can be found on the instrument:
Symbol
Explanation
T
ype 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.
F
ollow 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 f acilities f or recovery and recycling. Failing
to do so may endanger the environment.
0123
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,
Identif ication No. 0123, has approved the quality system.
M
edical Device.
S
erial number.
Date of manuf acture.
Manufacturer.
Reference number.