IMPORTANT SAFETY INSTRUCTIONS
3
D-0014930-A
– Otowave 102-C Operating Manual
2.
IMPORTANT SAFETY INSTRUCTIONS
The Otowave 102-C instrument must be used only by practitioners qualified to perform
tympanometric tests. It is intended for transient use as a screening and diagnostic tool;
however no surgical or medical procedure should be undertaken solely on the basis of
results obtained from the instrument.
2.1.
PRECAUTIONS
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT
The tympanometer is for indoor use only and should be used only as described in this manual.
Refer to the precautions specified in Section
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4.1
regarding the use of
batteries.
Before the first use of the instrument each day, or if suspect or inconsistent results are apparent, the checks
specified in Section 11 must be carried out. If these do not give the results specified, the instrument must not
be used.
Never insert the probe into a patient’s ear canal without a suitable ear tip fitted to the probe.
Use only the recommended disposable ear tips . These are for single use only - that is, each ear tip is intended
to be used once only for a single ear for a single patient. Do not reuse ear tips as this will pose the risk of ear-
to-ear or patient-to-patient cross-infection.
Do not immerse the unit in any fluids. See Section 13 of this manual for the proper cleaning procedure for the
instrument and its accessories and the function of single-use parts.
Do not use the instrument in an oxygen-rich environment or in the presence of a flammable anaesthetic mixture
or other flammable agents.
Do not drop or otherwise impact this instrument. If the instrument is dropped or damaged, return it to the
manufacturer for repair and/or calibration. Do not use the instrument if any damage is suspected.
The instrument must be stored and used indoors within the specified temperature, pressure and humidity
ranges, see Section 15.
As with all instruments of this nature, the measurements taken will be influenced by significant changes in
altitude & pressure. The Otowave 102-C 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.
WARNING
