Page 6 OM001-16 Otowave 102 Operating Manual
As with all instruments of this nature the measurements taken will be
influenced by significant changes in altitude & pressure. The Otowave 102
tympanometer must be re-calibrated at the intended operating elevation if it
is to be used at elevations greater than 1000m above mean sea level.
Do not attempt to open, modify or service the instrument. Return the
instrument to the manufacturer or distributor for all repair and servicing
requirements. Opening the instrument will void the warranty.
2.2. Electromagnetic compatibility (EMC) considerations
Medical electrical equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
in Section 17. This provides guidance on the electromagnetic environment
in which to operate the instrument.
Portable and mobile radio-frequency (RF) communications equipment can
affect medical electrical equipment. The instrument should not be used
adjacent to or stacked with other equipment; if this is unavoidable the
instrument should be observed to verify normal operation.
3. Principles of Operation
Please note: This operating manual is not intended as a training manual
for tympanometry. The reader should consult standard audiology texts for
the theory and application of the screening tests provided by this
instrument.
3.1. Compliance measurement
The Otowave 102 measures the compliance of the tympanic membrane
and middle ear by playing a continuous 226Hz tone into the ear canal at a
level calibrated to give 85dB SPL into a 2ml cavity. The sound level this
produces in the ear canal is measured using a microphone and the
compliance calculated from the result. In line with normal audiometric
practice compliance is displayed as an equivalent volume of air in ml.
3.2. Tympanogram
To record the tympanogram the compliance is measured while the air
pressure in the ear canal is varied from +200daPa to -400daPa by means
of a small pump. The compliance peaks when the air pressure is the same
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