Philips Avalon FM30 - Case 3: Medical Device Combined with a Medical or Non-Medical Device

7 Testing and Maintenance
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Case 3: Medical Device Combined with a Medical or Non-Medical
Device with one Device in a Non-Medically-Used Room
If you combine a medical device with a medical or non-medical device to form a medical electrical
system according to IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010 using a common
protective earth connection and one of the devices is located in a non-medically used room, additional
protective measures are required, e.g. usage of a separation device or additional protective earth
connection. The medical electrical devices or IT equipment may be located in or outside the patient
vicinity. After system installation incl. protective measures, a system test is required to ensure that the
resulting equipment leakage current does not exceed the limits of IEC 60601-1:2005+A1:2012/
EN 60601-1:2006+AC:2010.