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D-0115687-C (OM008) – 170 Operating Manual
5.4 Equipment classification
Type of protection against electric shock Powered via SELV
ClassII mains adapter
Degree of protection against electric shock Type B applied part
Degree of protection against ingress of water Not protected
Mode of operation Continuous operation
Equipment mobility Portable
The Model 170 Audiometer is classified as a Class IIa device under Annex
IX of the EU Medical Devices Directive. It is intended for use as a
screening audiometer instrument.
6 Symbols
The following symbols appear on the audiometer or mains adapter:
Definition: Refer to instruction manual (mandatory).
Definition: Type B applied part – an applied part
providing protection against electric shock, particularly
regarding allowable patient leakage current and patient
auxiliary current.
The applied parts are the left & right earphones, patient
response switch and the associated cables.
Definition: The output from the mains AC adapter is
Direct Current.
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