Investment in advanced medical device testing technology from Rigel Medical is reaping benefits at one of Israel’s private hospitals.
The 110-bed Herzliya Medical Center has been using the Rigel Uni-Therm electrosurgical analyzer for several years as part of a suite of equipment to undertake comprehensive testing and calibration of approximately 70 items of operating rooms and outpatient clinics radio frequency generators.
Capable of automating all required tests, the compact analyzer accurately measures the performance of equipment, including high frequency leakage, high current, power output and patient return plate alarm testing. Its ease-of-use and advanced capabilities have simplified performance testing procedures as part of the planned in-service preventative maintenance programmes the hospital undertakes, which are overseen by director of the Biomedical Department, Tameem Jaber.
He estimates that the time taken to complete these procedures has been cut by an estimated 40% using the Uni-Therm when compared to the biomed test equipment the hospital previously used.
He said: “Uni-Therm continues to contribute to raising test standards and delivering operational efficiencies. It has improved the ease by which our generators can be checked for electrical safety then a performance accuracy while the ability to produce one report covering all test procedures is extremely beneficial, saving even more time and effort.
“We can customise our auto-test sequences using the analyzer and can run through all the manufacturer’s recommended tests in under 10 minutes. This is significantly quicker and easier when compared to the biomed test equipment we used to use before turning to Rigel.”
Located north of Tel Aviv on the Mediterranean coast, the Herzliya Medical Center was the first facility of its kind in Israel to undertake heart surgery, neurosurgery, and endoscopic procedures among other complex operations. It has also led the way in the development of the country’s CT scanning technology, catheterisation, in vitro fertilisation, cytogenetic laboratory and ICU capabilities.
Tameem Jaber explained that the adoption of the Uni-Therm, which connects to Rigel’s Med-eBase asset management software, meets the medical center’s requirements for the beneficial production of reports and certificates for the device under test, which can be stored on either a local or remote database using a CMMS developed by a local software company.
“Using the analyzer makes IEC 60601-2-2 testing less complicated and easier at the hospital. The user-friendly screen on the unit provides step-by-step connection instructions and simple analysis data, which can be interpreted quickly to check the equipment under test is working properly,” he said.
“The ability to enter quickly the medical device manufacturer’s own test specific programmes and print off customised check labels is also beneficial. The Uni-Therm analyzer was designed more specific to biomedical testing environment in addition to the ability to test and calibrate RF generators of wide manufactures using a special test cables or custom made for example for testing MITEK VAPR VUE (JNJ) or MALIS CODMAN CMC-V or GEN11 ENSEAL Harmonic Scalpel.”
The Uni-Therm features onboard memory, test automation, comprehensive data management capabilities and a wide range of in-built resistors. USB technology improves connectivity to other equipment for the rapid downloading of test data and the uploading of the electrosurgical device’s power curves as well as test specific programmes. Output waveforms can be examined through a built-in scope output, which allows for easy confirmation of the desired waveform shape.
The Uni-Therm is among several Rigel defibrillator analyzers, infusion pump analyzers and combination vital sign simulators the hospital uses, which contribute effectively towards ensuring compliance with appropriate international test standards, including IEC 60601-2-2. These include the UNI-SIM, UNI-Pulse, Rigel 288+ and Multi Flow to test and calibrate patient monitors, infusion pumps and defibrillators.