Performance Testing Support

Advice and support for users of Rigel’s performance analyzers

Get the most out of your Rigel performance analyzers and find the answers to your questions with our FAQs.

FAQs and Articles

Why performance test?

Medical devices are often high risk instruments, which are used to detect, diagnose, and provide treatment to patients. Performance testing of these devices ensures devices are functioning properly and accurately. In healthcare organisations, this is crucial in improving overall patient safety. Clinicians with high accuracy medical measurements ensure correct diagnoses through patient monitoring and an overall better delivery of treatment. Performance measurements also ensure the devices meet manufacturer specifications/international standards. Moreover, with healthcare technology management growing, it’s important that these results are fully traceable.

Accuracy of all devices tends to stray over a period of time but regular testing ensures measurements fall within acceptable limits. Rudimentary inaccurate measurements can lead to incorrect diagnoses.

Patient monitors are a prime example of why high accuracy is required. Besides alerting clinicians to vital sign values, modern patient monitors actually provide direct physiological input data to control connected life support devices. Furthermore, central patient monitoring systems mean that one clinician may be monitoring many critical care patients at once.

What is performance testing?

Performance testing is implemented to ensure medical devices perform safely, reliably and accurately. The accuracy of a medical device is tested by comparative analysis with standard measurements where the accuracies are known. Regular performance testing is essential for compliance and is required by both manufacturers and internationally recognised standards.

Performance analysers or simulators are often used to provide the test and measurements standard for testing medical devices e.g., a patient simulator will accurately mimic many physiological parameters to test a patient monitor. Performance analysers provide a simple solution to preventative maintenance schedules as they are quite often fully automated. Asset management for the performance measurements of medical devices is extensive, particularly as the number of medical devices increases.

How to performance test?

Performance tests are performed according to international standards and manufacturers recommendations to ensure accuracy and precision. The measurement accuracy of each medical device relies on a comparative measurement standard whereby the accuracy is recognised, usually through the use of performance analysers. Tests are implemented at regular intervals and specified accuracy limits are found in medical device manufacturer’s manuals.

These performance tests ensure that equipment is working within its specification and is fit for purpose. It’s important that the accuracy of whole systems are measured, not just the device alone. Test procedures can therefore be complex, which is why performance analysers are used to quickly and accurately verify medical devices. All-in-one parameters analysers or simulators provide effective methods of testing to biomedical engineers, medical physics staff and service engineers.

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