Equipment Classification; Audiometric Standards - Welch Allyn MICROTYMP 4 User Manual

Welch Allyn MicroTymp® 4 Tympanometer User Manual
E
QUIPMENT CLASSIFICATION
The Welch Allyn MicroTymp 4 Tympanometer is classified as a Class IIa device under Annex IX
(Section 1) of the EU Medical Devices Directive.
Type of protection against electric shock
Degree of protection against electric shock
Degree of protection against ingress of water
Mode of operation
Equipment mobility
A S
UDIOMETRIC TANDARDS
The Welch Allyn MicroTymp 4 Tympanometer is designed to meet or exceed the Aural
Impedance/Admittance Instrument Standard Requirements - Type 2 listed below.
ANSI S3.39 Specification for Instruments to measure Aural Acoustic Impedance and Admittance
(Aural Acoustic Immittance)
IEC 60645-5 Electroacoustics - Audiometric Equipment – Instruments for the measurement of
aural acoustic impedance/admittance
ISO 389-2 Reference Equivalent Threshold SPLS for Pure Tones and Insert Earphones
DIR 80024157 Ver A
Internally Powered
Type B applied part
Not protected
Continuous operation
Portable
Page 44