8
61
Standards, Specifications, and
Accessories
Standards and Compliance
The TM286 meets
Tympanometry modes
Standards: UL 60601-1 Medical Electrical Equipment Requirements for Safety
IEC/EN 60601-1 General Requirements for Safety
CSA C22.2 No.601-1-M90
ANSI S3.39-1987 Aural Acoustic Impedance Admittance (Type 3)
IEC 60645-5 Aural Acoustic Impedance/ Admittance (Type 2)
ANSI S3.6-2004 Audiometers (Type 4)
IEC 60645-1 Pure Tone Audiometers (Type 4)
GL2005-00014 (ASHA 2005) Guidelines for Manual Pure-Tone
Threshold Audiometry
Protective Classification: This system is intended for continuous operation and has a protective
classification of Class 1.
Class 1 Type B
Probe Tone: 226 Hz, ±2%
Sound Pressure Level: 226 Hz: 85.5 dB SPL, ±2.0 dB, measured in a 2.0 cm
3
coupler
Harmonic Distortion: <3%
Admittance (Compliance) Range: 226 Hz: 0.0 to 1.5 cm
3
or 0.0 to 3.0 cm
3
Notes:
1. The range is automatically selected based upon the amplitude of the
compensated tympanogram.
2. The maximum uncompensated (ECV + tympanogram peak) admittance
(compliance) range is 0 to 5.0 cm
3
.
3. ECV/cavity limits for initiating pressurization is 0.2 to 5.0 cm
3
.
Compliance Accuracy: ±0.1 cm
3
or ±5%, whichever is greater.
To Next Page
Loading...
Need help?
General
