An extended protocol for usability validation of medical devices: Research design and reference model

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences and derive performance measures. Secondly, a...

With how many users should you test a medical infusion pump? Sampling strategies for usability tests on high-risk systems

Usability testing is recognized as an effective means to improve the usability of medical devices and prevent harm for patients and users. Effectiveness of problem discovery in usability testing strongly depends on size and representativeness of the sample. We introduce the late control strategy, which is to continuously monitor effectiveness of...

Transfer standard device to improve the traceable calibration of physiotherapy ultrasound machines

Ultrasound (US) physiotherapy as a clinical treatment is extremely common in the Western world. Internationally, regulation to ensure safe application of US physiotherapy by regular calibration ranges from nil to mandatory. The need for a portable power standard (PPS) has been addressed within a European Community (EC)-funded project. This PPS...

A low frequency meter with instantaneous response

A practical method is described for instantaneous frequency measurement by computation of the reciprocal of the time interval between two events. Use is made of inexpensive integrated circuits.