New Rigel SafeTest 60+ analyser for improved high volume medical device testing
The implementation of rapid and accurate medical device and laboratory equipment testing is provided by Rigel Medical’s newly upgraded SafeTest handheld safety analyser.
Designed for high performance and accurate electrical testing to reduce the risk of electrical device fault, the improved SafeTest 60+ is a compact, rugged and reliable safety analyser that is designed to accommodate the demands of high-volume testing regimes.
Offering an easy-to-use colour coded user interface, push button operation and fast step selection of test routines, and available in a wide range of power configurations to suit local and international markets, the tester delivers point-to-point insulation resistance testing from 100K – 100MΩ with added patient applied parts testing.
Featuring an accessible and clear user interface (UI), which allows the operator to select the required tests quickly with a single key, the high-performance instrument includes an extensive selection of safety tests for hospital and medical equipment.
The SafeTest 60+ provides basic testing of medical equipment with applied parts, both patient current leakage and insulation measurement to ensure electrical safety. It also specialises simpler devices like medical beds and chairs, operating tables, hoists, infusion pumps, CPAPs (continuous positive airway pressure), centrifuges and other similar equipment that do not require patient lead testing.
As such, the SafeTest 60+ is suitable for electrical testing to ensure compliance with a range of international safety standards including leakage testing to AAMI ES 60601, NFPA-99, IEC 62353 and IEC 61010. Key features for dynamic testing include:
- Active pass/fail thresholds during measurement;
- Patient applied parts testing;
- Manual control of fault conditions and tests;
- Accurate high current, low energy earth bond testing;
- Automatic warning of secondary earth/ground paths; and
- Point to point insulation testing
To meet the needs of some specific types of equipment, the unit also has the capability to carry out accurate ground bond testing to NFPA-99, IEC 62353 and IEC 61010 using Rigel’s high current, low energy test technology. In all cases, full manual control means only those specific tests that are required need to be carried out, with selected single fault conditions ensuring that testing is carried out quickly and efficiently – without any compromise in accuracy or integrity of testing.
As part of the new streamlined approach to carrying out electrical safety tests, an automatic warning of secondary ground paths ensures that users are alerted when invalid results occur, eliminating time consuming re-tests and ensuring correct and valid results are provided first time.
The SafeTest 60+ analyzer is the latest addition to the comprehensive range of high-performance biomedical test equipment from Rigel Medical. View our full product range today.
New Rigel Medical iOS 288+ Downloader app for faster test and records storage
The new downloader iOS 288+ mobile phone app from specialist Rigel Medical, enables biomed device engineers to improve electrical safety test data capture and management.
The app, which avoids the need to print off records, is part of a digital toolkit used to support the 288+, an electrical safety analyser designed to perform routine field tests on medical electrical equipment. These tests play a critical role in revealing faults with medical equipment in hospitals and healthcare facilities, highlighting any compliance issues and improving patient safety.
Data downloaded directly from the Rigel 288+ via Bluetooth connection to mobile devices improves traceability, and reduces the time-consuming process of transferring and storing completed test records to available asset maintenance software, as part of a planned preventive maintenance schedule.
Available in English, French, German, Italian, Polish, Portuguese, Spanish and Turkish, the app allows company logos and other details together with personal signatures, to appear on individual engineer reports for secure identification. Single test results, multiple results, or all results can also be added to these reports by selecting the relevant checkbox, which can then be viewed and forwarded to databases in PDF and/or CSV formats.
The Downloader app is available from the Apple store and is compatible with Rigel 288+ devices containing the new Bluetooth Module (288+ models “P” (2022) serial number and later.)
In a separate move, Rigel has also updated its Android version of the downloader with additional languages and improved storage. The updated version is available via the Google Play Store.
New product manager drives growth for Rigel Medical in North America
Bio medical device test and measurement specialist Rigel Medical has invested further in the expansion and growth of its US operations with a senior appointment.
Lewis Lennard has joined the US operation in Tampa, Florida as a product manager. Bringing eight years’ experience to the role, he will be responsible for managing the medical product portfolio and supporting brand sales across North America, which is one of the largest medical device markets in the world.
He will also be involved in analyzing market trends and identifying opportunities to support new business development as well as monitoring and reporting on market behaviors and trends to inform strategic planning and marketing.
The move by Lewis Lennard, who was previously an application engineer with Rigel Medical based in the UK, comes at a time when the market for electrical safety test products in North America continues to show huge potential for growth.
He said: “Rigel Medical is fast building a reputation and presence in the industry at a time when the market is rapidly growing. I look forward to working alongside a team focused on providing high quality products, unsurpassed customer service, and innovation that adapts and expands to meet market standards.”
Seaward is part of Metrawatt’s GMC Instrumentation Group, a collaboration of separate specialist test equipment manufacturing businesses based in Germany, Switzerland and the USA.
Sean Daley, vice president and chief operating officer at Seaward USA, said: “I very much look forward to working with Lewis as we continue to strengthen our US team. He has excelled throughout his time in Seaward, going above and beyond in many areas. The growth opportunities in the North American marketplace align with his ambition and will add further success to Rigel Medical’s growth in the territory.”
Seaward Group USA supplies a wide range of electrical safety instruments to ensure the safety of any product or appliance from the design, compliance and manufacturing stages through to servicing repair and calibration. This includes advanced technology laboratory and production line testers capable of carrying out hi-pot, ground bond and a variety of other tests, as well as EMC test equipment. Based in Florida, the company has an extensive national US sales, service and calibration capability.
Tributes paid to Seaward’s Jack Barrett who has died
Seaward Group USA is saddened to announce the death of its former colleague Jack Barrett at the age of 68.
A popular, larger-than-life figure in the biomedical community, Jack joined the company as business development manager before becoming vice president based in the office in Tampa, Florida.
His dedication, hard work and expertise saw him contribute significantly to developing the business in the USA, increasing revenues, winning new customers and securing success right across the country until his retirement in late 2019.
He was a real character, who made many friends over the years as he immersed himself in his work – he had a strong work ethic – said Michael Walton, category manager of Rigel Medical, who added: “Jack, who lived life to the full, was well-loved and will be fondly remembered by his many friends, colleagues and customers who worked with and knew him over the years.
“It is due to his commitment, vision, hard work and diligence that Seaward USA is where it is today – successful, growing and leading the field in US biomedical engineering, renewable energy and health and safety testing and measurement.”
Jack, who died suddenly and unexpectedly on June 2nd, was an avid collector of fine wine, and loved fishing, traveling and classic cars. He is survived by his wife Maryann, one daugther Kelli, a son TJ, and four grandchildren.
Specialist Biomed Test Technology Ensures Critical Performance of AEDs
Advanced biomedical test technology is helping to ensure that essential life saving equipment is maintained in full working order so that it performs reliably during those vital emergency situations in which it is needed.
The specialist biomed engineering team at the busy Deaconess Midtown Hospital in Evansville, Indiana is using a Rigel UniPulse 400 defibrillator analyzer for the planned maintenance and troubleshooting testing of the 55 defibrillators located around its facilities.
The UniPulse 400 is specifically designed to comprehensively test all defibrillators accurately and efficiently. The lightweight, battery powered and portable unit is capable of analyzing all monophasic, biphasic, standard, and pulsating waveforms and is also equipped with a special pacer function for comprehensive testing of defibrillator functionality.
In previous years both the US Food and Drug Administration (FDA) and the Department of Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK have highlighted the importance of the life saving treatment provided by automatic external defibrillators (AEDs) and the need to ensure against unexpected component failure or other technical problems that might affect their reliability.
Brian Pierce, Midtown Hospital Biomed Team Lead, recognizes the essential role that AEDs play and the critical need for them to perform efficiently and accurately when needed.
He said: “We never know how often or when a defibrillator will be needed, so it is very important that when they are required, they function properly.
“In this respect, the UniPulse 400 has all the common features needed to perform full preventative maintenance on a defibrillator. As well as being lightweight and easily carried around the hospital by our technicians, the crisp color display and simplicity of use means new staff members can quickly learn how to use it.
“An analyzer is no good to us if we cannot rely on its proper operation and accuracy. I feel the UniPulse 400 is very durable and enables us to carry out important testing with confidence.”
The Rigel UniPulse 400 incorporates advanced measurement technology, including dedicated fast keys and automatic programs to enable biomed test engineers to select the relevant test function in seconds.
The large internal memory and on-board results storage also helps to reduce test time and helps hospital teams work towards automated database record keeping systems.
The UniPulse 400 forms part of the comprehensive Rigel Medical range of world class biomedical testing solutions for healthcare environments.
As well as the UniPulse400, other Rigel equipment used by the biomed team at the Deaconess Midtown Hospital includes a Uni-Therm electrosurgical analyzer and SafeTest 50 and 288 electromedical equipment safety analyzers.
Rigel Multi-Flo Specified for Indonesian Government Test Centre
One of South East Asia’s leading test and calibration service centres has specified Rigel Medical’s Multi-Flo infusion pump analyzer for improved compliance testing of medical devices.
The move by Java-based BPFK Surakarta, which is government backed and operates similar facilities across Indonesia, has simplified and improved the calibration of syringe and infusion pumps using Multi-Flo as part of an extensive service provided to local hospitals and other healthcare facilities.
Investment in the analyzer has increased the speed and ease by which medical devices are checked annually for electrical safety and performance accuracy to meet Indonesian health regulations, notably UU.RI. No. 44 (2009) and Permenkes RI No.54 (2015). Up to four pumps can be checked simultaneously using the Multi-Flo at the Surakarta test centre, significantly reducing the time taken to complete calibration and ensure devices comply with safety standards.
BPFK Surakarta, which provides services to customers in the private and public hospital sectors, has developed into one of the main test and calibration centres on the Indonesian island of Java, establishing itself as a leading partner in the implementation of the monitoring and evaluation of health facility services, completing more than 2,210 equipment tests per year.
The Multi-Flo, which was supplied to BPFK by Rigel’s Jakarta distributor PT Fania Ersa Pratama, also meets IEC 60601-2-24 requirements and can be used for high and low flow, occlusion, back pressure and bolus measurement and features variants of one, two and four independent channels.
Each channel can be tested simultaneously across a range of 100 μL (microlitre) to 1,500 mL per hour with results stored in the instrument’s large internal memory. With a sampling rate of 1Hz, the instrument can accurately detail any changes in flow and pressure rates, providing a real-time picture of the quality of infusion.
Head of medical device testing/calibration laboratory installation at BPFK Surakarta, Muhammad Afifudin, said Rigel Medical met the requirement for a high quality, accurate and rapid global test solution.
He said: “Multi-Flo provides a very good solution for the calibration of syringe and infusion pump to Indonesian government requirements. Our biomed engineers really appreciate that it’s quick and easy-to-use, saving time, and allowing them to provide an efficient service and better standards of care.
“It incorporates an excellent array of features, while the added value benefits, such reliable connectivity and easy-to-follow instructions, are particularly impressive. The fact that it’s a British instrument is also important – quality is assured and good after sales maintenance and support is available.”
The Multi-Flo is among a range of Rigel defibrillator analyzers, infusion pump analyzers and combination vital sign simulators, which contribute effectively towards ensuring compliance with appropriate international test standards, including IEC 60601-2-2. These include the UNI-SIM, UNI-Pulse 400, UNI-Therm and 288+ to test and calibrate patient monitors, infusion pumps and defibrillators.
Advanced Biomedical Test Technology Boosts Hermed Spain Expansion Plans
Continuing investment in advanced test technology is helping one of Spain’s leading biomedical device service companies start 2021 with a significant expansion of its operations.
Hermed Spain was established in 2017 and provides specialist assistance to hospitals and healthcare providers with the regulatory testing and management of their electromedical technology.
Already responsible for medical device service, maintenance and repair for Madrid City Council’s emergency ambulance service and in a number of private and public hospitals in Madrid, Barcelona and Zaragoza, from January 2021 Hermed has further extended its operations to include four more public hospitals in Madrid.
As a result of the new contract, the company’s team of biomedical service engineers and technicians has grown from 35 to 50 and all are equipped with the latest Rigel Medical test technology to help them undertake their compliance testing more effectively and time efficiently.
Given the wide variety of healthcare facilities and types of medical devices that come under Hermed’s supervision, Rigel provides the service teams with a full suite of specialist biomedical test analysers and patient simulators.
These include the Uni Sim vital signs simulator, the Uni Pulse 400 defibrillator tester, the Uni-Therm high current electrosurgical analyzer and the Rigel 288 Plus biomedical equipment safety tester.
This specialist range of equipment enables field engineers and hospital technicians to carry out their critical work to ensure that vital healthcare technology and patient connected medical equipment is properly maintained, checked for electrical safety and continues to perform accurately.
Dr Marta Villarejo, Director General of Hermed Spain, explains: “In supporting our clients our aim has been to develop a new service model for managing electromedical devices that combines value, safety and economic stability.
“To achieve this, working efficiently is essential and with so many different medical devices to inspect, test and maintain across different healthcare sites, ease of use and portability of test equipment are very important considerations for our engineers.
“In this respect, the versatility and compact, lightweight design of the Rigel units means they provide very mobile test solutions, allowing us to carry out very efficient testing schedules that help us to provide better standards of customer service.”
In addition to the practical benefits associated with carrying out important on-site inspections, Dr Villarejo also highlighted a number of technical features of individual Rigel products that are particularly useful in carrying out the compliance testing, overhaul and maintenance of devices.
Dr Villarejo said: “When testing electrosurgical generators, for example, our engineers find that the full colour screen displays and easy-to-follow connection diagrams provided on the Uni Therm are particularly useful in eliminating potential errors.
“Similarly, the Uni-Sim Vital Signs Simulator has proven itself to be a very practical tool. By bringing together NIBP, SpO2, ECG, temperature, IBP and respiratory functions in one piece of equipment, it greatly facilitates the field service activities by Hermed engineers, saving time and avoiding the need to carry several pieces of equipment.”
As well as supplying Hermed with specialist test equipment, Rigel also supports the company with a range of product support and user training programmes.
Sam Teta, Business Development Manager for Rigel, said: “By taking responsibility for the inspection, service and maintenance of specialist electromedical technology, Hermed enables healthcare providers to focus on patient services and we are delighted that this approach has been so successful for the company.
“We greatly value the relationship we have developed with the business and we are committed to supporting them in their future expansion plans with continuing advances and innovation in the Rigel range.”
Uni-Therm Aids Rapid Biomed Equipment Testing At Israel Hospital
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 programs 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 added 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,”
Tameem Jaber added that the ability to enter quickly the medical device manufacturer’s own test specific programs 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,” he said.
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 programs. Output waveforms can be examined through a built-in scope output, which allows for easy confirmation of the desired waveform shape.
New Chief Executive for Seaward
Electrical test and measurement company, Seaward Electronic Ltd. who own Rigel Medical, is setting its sights on further market growth with the appointment of a new chief executive.
Electronics industry specialist Chris Callan takes up the role after building a highly successful career working with businesses around the UK and in the USA.
Since graduating as an electronics and software engineer, Chris has gained widespread experience in business development, product management and executive roles in the medical, automotive and telecoms markets. Most recently he was vice-president and general manager of an international components and test equipment manufacturer in the aviation sector.
In taking up his position at Seaward, Chris believes there are considerable opportunities for the company to build on its successful market presence, both in the UK and overseas, and is targeting further growth for the company with the introduction of new products and services.
He said: “I am delighted to be joining Seaward and I am very excited about the future potential of the business. The company’s strong reputation and international success were major attractions for me and I am looking forward to working with everyone to continue to grow and take the business forward.
“In particular, the company’s commitment to technical innovation and development will remain a key priority as we look to expand the product range, develop new applications and secure a bigger market share.
“To help us achieve this ambition, we will be investing strongly in the company’s renowned engineering capabilities and by putting product integrity and new technology at the heart of everything we do.”
The County Durham-based Seaward, with an office in Tampa, Florida serving the USA, employs around 160 people and is a market leading manufacturer of electronic test and measurement instruments used in a wide variety of electrical, medical, industrial and energy sector applications.
In 2015 Seaward became part of Metrawatt’s GMC Instrumentation Group, a collaboration of separate specialist test equipment manufacturing businesses based in Germany, Switzerland and the USA.
Dr Hans-Peter Opitz, of GMC-Instruments GmbH, said: “We would like to welcome Chris to Seaward and very much looking forward to working with him.
“We believe the strengthening of the management team with this new appointment will provide the basis for the successful further development of both Seaward and the group for the benefit of our international customer base.”
By becoming CEO, Chris Callan takes over from interim managing director Tom Talbot who will stay with Seaward as chief operating officer.
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