Periodic Calibration - Interacoustics AT235 Instructions For Use Manual

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 f ile.
Recalibration should be perf ormed af ter:
1) A specif ied time period has elapsed (12-month period maximum, annually).
2) When a specif ied 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, malf unction, or a repair or part
replacement has been perf ormed 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 perf ormed 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
specif ications. The calibration procedure will validate all relevant perf ormance requirements given in
ANSI/ASA and/or IEC.
D-0128073-C – 2022/05
AT23 5 - Instructions for Use - US Page 43