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Service Technical Bulletin 012-16 Electrical Safety Testing of FUJIFILM SonoSite Products October 28, 2016
FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
For release to: FUJIFILM SonoSite Internal Authorized Repair Facilities Authorized Dealers/Distributors FUJIFILM SonoSite Customers SonoSite.com
Electrical Safety Testing of FUJIFILM SonoSite Products (Edge II, SII, Edge, M-Turbo, S Series, NanoMaxx, MicroMaxx, and Titan) Problem: Interpretation of IEC 60601-1 as it applies to the listed FUJIFILM SonoSite ultrasound products. Solution: The following is intended as an informative guide that explains the classification of our ultrasound products with particular regard to Earth Leakage and Ground Resistance testing. World-wide Test standards for electrical safety: All electrical qualification tests on FUJIFILM SonoSite products are conducted according to IEC 60601-1 and its collateral standards. We also conduct tests for National Differences according to UL, CSA, AS/NZS and others. System Classification and Construction: The classification of our ultrasound systems as a whole system is Class I. This is because of the separate Class I power supply that connects with the protective earth (PE) through the power cord. Technically the power supply is a “Class I device provided with reinforced insulation”. It is a medical grade supply providing an output below 60V DC, with double isolation between mains and its output secondary. On the output side of the Class I power supply, the PE is not directly passed through so there is not a PE contact on the system. From here on, the construction is similar to Class II with a functionally earthed (FE) enclosure. Additionally, in the battery operated configuration (unplugged from the AC power supply), the system is Classified as “Internally Powered”. Ground bond and earth leakage are not applicable tests to this configuration since there is no PE connection. Safety testing by Bio-Medical Technicians: Testing for ground is only applicable to the “ACCESSIBLE PARTS OF CLASS I EQUIPMENT SEPARATED FROM LIVE PARTS BY BASIC INSULATION CONNECTED TO THE PROTECTIVE EARTH TERMINAL”. Since the AC /DC power supply has an all plastic case and the ultrasound systems are only connected to mains through this supply without direct connection to the PE, the safety ground bond test to support protectively earthed metal is not applicable.
D19899 Rev A
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Service Technical Bulletin 012-16 Electrical Safety Testing of FUJIFILM SonoSite Products October 28, 2016
Testing earth leakage of the system connected through the power supply according to Class I is a valid test. Enclosure and Patient leakage may also be conducted for the system. Specific enclosure and Patient leakage tests may also be conducted in the “internally powered” configuration, but these tests are not usually performed by maintenance or field personnel. These tests have been performed during product qualification and could be performed if desired/required. The metal stand (Edge-Stand, H-Stand or V-Stand) is electrically isolated from the system (floating, not PE or FE) and does not require ground resistance or ground bond testing. All the electrical cords inside the stand are double insulated from the stand and it is just like the cords were not inside the stand but just connected on the bench-top. Think of the stand as similar to an IV stand that supports other equipment. The IV stand is not grounded, and the other equipment is connected to mains through their power cords. Peripheral accessories such as the medical grade printers and video recorders are generally Class I. These may be tested for ground resistance if they have accessible parts separated from live parts by basic insulation connected to PE. They may also be tested for electrical leakage as type B devices as desired/required.
If there are any questions please contact FUJIFILM SonoSite Technical Support: Phone: 877.657.8118 (U.S. and Canada) 1.425.951.1330 (Worldwide) Email: [email protected]
D19899 Rev A
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