5.3 Physical Data
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Battery power (optional): 4x1.5V “C” cells (alkaline recommended)
Mains power: 100-240Vac; 50/60Hz; 0.4A
Dimensions: 270mm long x 175mm deep x 68mm high
Weight (no batteries): 0.75kg (approx)
Safety: IEC 60601-1 (plus UL, CSA & EN deviations)
EMC: IEC 60601-1-2
CE mark: To the EU Medical Device Directive
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 116 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.