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Solution:
The Mobile Docking Station can be tested to the grounding impedance test using certain other metal
locations but not using the metal connectors of the Minidock. The location on the Mobile Docking
System that can be tested is from the ground pin in the IEC outlet strip to the metal case of a SonoSite
peripheral device where the power cord of the peripheral device is plugged into the outlet strip. Other
metal parts of the Mobile Docking System should not be tested since the metal parts of the MDS do
not act as an enclosure for live parts.
Regarding the connections on the Minidock, such grounding would be required if in normal and
single fault conditions leakage current could exceed leakage limits when measured from the
ungrounded accessible metal part (IEC 60601-1, Sec 17(g)). There are exceptions to this rule
limiting leakage from an accessible part. IEC 60601-1, Sec 16(a) 5 allows:
Where the occurrence of a CONDUCTIVE CONNECTION, either directly or through the body of the
OPERATOR, between a part accessible without the use of a TOOL, and a PATIENT is impossible in NORMAL
USE, such a part may assume, in case of a fault in its BASIC INSULATION, a voltage to earth not exceeding
25V a.c., or 60V d.c.
In normal use, or operation according to the instructions for use (IEC 60601-1, Sec 2.10.8), the
patient does not contact the connector assembly of the Mini-Dock that is located in the back of the
Mobile Docking Station. The voltages in the Mini-Dock are a maximum 15V dc. Thus the MiniDock would come under this exception and the metal parts would not need to limit leakage by being
protectively earthed.
D04756 Rev A, Page 1 of 2
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK addressed this issue
and it resulted in the same analysis and conclusion (MHRA 2004/011/022/291/001-SonoSite Titan
Electrical Safety Issues). See SonoSite document M01456, MHRA Finding Concerning Minidock
Grounding Issue for detailed report.
Confidential
Page 2 of 2
D04756 Rev A