Markings - Interacoustics Eclipse Instructions For Use Manual

Eclipse Instructions for Use - US

2.3 Markings

The following markings can be found on the instrument:
Symbol Explanation
Type B applied parts.
This is used for parts applied to the patient that require only ordinary electrical
protection e.g., headphones.
Type BF applied parts.
This is used for parts applied to the patient that require a higher degree of
electrical protection e.g., patient coupled electrodes.
Refer to instruction manual.
or
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.
0123
Year of manufacture.
Do not re-use.
Parts like ear-tips and similar are for single use only.
I On (Power: connection to the mains).
Equipotentiality
O Off (Power: disconnection from the mains).
This label is located on the backside of the Eclipse Hardware.
The label to the left shows manufacturer and
address.
Eclipse serial number is SN802872
Produced year 2011
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