Revised 4/11/08 7-3
Specifications
Specifications
Standards: UL 60601-1 Medical Electrical Equipment Requirements for Safety
IEC/EN 60601-1 General Requirements
CSA C22.2 No.601-1-M90
ANSI S3.39-1987 Aural Acoustic Impedance Admittance (Type 3) IEC 1027-1991
Aural Acoustic Impedance/ Admittance (Type 3 ANSI S3.6-1989 Audiometers
(Type 4)
IEC 60645-1 Pure Tone Audiometers (Type 4)
PTB Certificate No. 15.11-94/53 Pure Tone Audiometers (Type 4)
Protective Classification: This system is intended for continuous operation and has
a protective classification of Class II, Type B.
Class II Type B equipment symbols
Tympanometry/Reflex modes
Probe Tone: 226 Hz, ±3%
Sound Pressure Level: 85.5 dB SPL, ±2.0 dB, measured in a 2.0 cm
3
coupler
Harmonic Distortion: <5%
Admittance (Compliance) Range: 0 to 1.5 cm
3
0 to 3.0 cm
3
NOTES:
1. The range is automatically selected based upon the
amplitude of the compensated (tymp only)
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
6.0 cm
3
. Compliance Accuracy: ±0.1 cm
3
or ±5%,
whichever is greater
Pneumatic system
Pressure Range: +200 to -400 daPa
NOTES:
1. daPa = 1.02 mmH20
2. Pressure sweeps to at least -100 daPa. To save test
time, pressure
3. Sweep stops once tympanogram returns to baseline
after -100 daPa.
4. Full pressure sweep for 6 cm
3
from sea level to 7000 ft.
altitude with no leak.
Pressure Accuracy: ±10 daPa or ±15%, whichever is greater
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