||The purpose of this technical specification is to establish standard methods for a qualitative check of the performance of ultrasound physiotherapy devices during their lifetime, and to provide guidance on calibration requirements and techniques.
To ensure that the ultrasound physiotherapy equipment is in an appropriate condition for use, a regular quality check is necessary. This technical specification defines acceptance, weekly and annual checks. The acceptance test checks the delivery of the device and its performance at the start of its lifetime. The weekly check is a simple qualitative check of device operation. In the annual check, in addition to a qualitative check, a quantitative check is defined. Examples are provided of weekly and annual test reports.
This report also gives guidance to the testers concerning the measurement of acoustic output.
Annual testing is to be performed by a skilled tester, e.g. biomedical engineer, medical physicist, medical device service agent, commercial tester, test house, national measurement institute or manufacturer.