Welch Allyn MICROTYMP 4 - Equipment Classification; Audiometric Standards

Welch Allyn MicroTymp® 4 Tympanometer User Manual
DIR 80024157 Ver A Page 44
EQUIPMENT 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
Internally Powered
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
AUDIOMETRIC STANDARDS
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