Periodic Calibration - Interacoustics AT235 Instructions For Use Manual

AT235 Instructions for Use - EN
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4.6 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 a specified usage (operating hours) has elapsed. This is based on usage and environment,
requested by the audiometer's owner. Typically this is an interval of a 3- or 6-month period, based on
instrument usage.
3) 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.
4) Whenever user observations or patient results appear to be the result of questionable operation of an
audiometer.
Annual calibration:
It is recommended that an annual calibration be performed by a trained technician/ a competent laboratory,
knowledgeable and up to date in the relevant requirements of ANSI/ASA and/or IEC and the device
specifications. The calibration procedure will validate all relevant performance requirements given in
ANSI/ASA and/or IEC.
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