AA222 Instructions for Use – US
4.5 Periodic calibration
Minimum periodic calibration requirements:
Minimum calibration interval of once (annually) per 12-month period.
Records of all calibrations should be kept on file.
Recalibration should be performed after:
1. A specified time period has elapsed (12-month period maximum, annually).
2. When an audiometer or transducer has had a shock, vibration, malfunction, or a repair or part
replacement has been performed which potentially may have put the audiometer out of calibration.
3. Whenever the user suspects patient results to be inaccurate.
Annual calibration
It is recommended that an annual calibration be performed by a trained technician/a skilled laboratory,
knowledgeable and up to date in the relevant requirements of ANSI/ASA and/or IEC and the device
specifications. The calibration procedure must validate all relevant performance requirements given in
ANSI/ASA and/or IEC.
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