OM001-16 Otowave 102 Operating Manual Page 35
excluding probe
210mm long including probe
Weight (without batteries)
Operating temperature range
30% to 90% RH, non-condensing
Operating atmospheric pressure
range
980 to 1040 mb (see Section 2)
Transport and storage
temperature range
Transport and storage humidity
range
10% to 90% RH, non-condensing
Transport and storage
atmospheric pressure range
IEC 60601-1(plus UL, CSA & EN
deviations)
IEC 60645-5, Type 2 Tympanometer
To the EU Medical Device Directive
14.2. Equipment classification
Type of protection against electric shock Internally Powered
Degree of protection against electric shock Type BF applied part
Degree of protection against ingress of water Not protected
Mode of operation Continuous operation
Equipment mobility Portable
The Otowave 102 Tympanometer is classified as a Class IIa device under
Annex IX (Section 1) of the EU Medical Devices Directive.
14.3. Symbols
Definition: Refer to instruction manual (mandatory)
Definition: Type BF applied part – an applied part
providing a higher degree of protection against electric
shock than that provided by a Type B applied part,