GSi ALLEGRO - EQUIPMENT CLASSIFICATION; AUDIOMETRIC STANDARDS

GSI Allegro Tympanometer User Manual
D-0120695 Rev D 2022-06 Page 44
EQUIPMENT CLASSIFICATION
The GSI Allegro Tympanometer is classified as a Class IIa device under Annex IX (Section 1) of the
Medical Device Regulation (EU) 2017/745 .
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 GSI Allegro 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