GE HEALTHCARE
D
IRECTION 5305880-100, REVISION 3 LOGIQ™ 100 PRO SERVICE MANUAL
Chapter 10 - Quality Assurance Page 10-13
10-6-2 GEMS Leakage Current Limits
The following limits are summarized for NFPA 99 (For USA) and IEC 60601-1 Medical Equipment
Safety Standards. These limits are GEMS standards and in some cases are lower than the above
standards listed.
*Mains Applied refers to the sink leakage test where mains (supply) voltage is
applied to the part to determine the amount of current that will pass (or sink) to
ground if a patient contacted mains voltage.
The following tests are performed at the factory and should be performed at the site. These tests
are: grounding continuity, chassis leakage current, probe leakage current, and ECG leakage
current. All measurements are made with an electrical safety analyzer Model 600/600E built by Dale
Technology Corporation or equivalent device.
Country Normal Condition Open Ground Reverse Polarity Open Neutral
USA
N/A
0.3 mA 0.3 mA N/A
Other
0.1 mA
0.5 mA 0.5 mA 0.5 mA
Table 10-13 Chassis Leakage Current Limits—Accessible Metal Surfaces
Country
Normal
Condition
Open Ground
Reverse
Polarity
Open Neutral
*Mains
Applied
USA
0.05 mA
0.05 mA 0.05 mA 0.05 mA N/A
Other
0.1 mA
0.5 mA 0.5 mA 0.5 mA 5.0 mA
Table 10-14 Type BF Applied Part Leakage Current Limits - Non-Conductive (Floating)
Surface and Cavity Probes
Country
Normal
Condition
Open Ground
Reverse
Polarity
Open Neutral
*Mains
Applied
USA
0.01 mA
0.05mA 0.05 mA N/A 0.025 mA
Other
0.01 mA
0.05 mA 0.05 mA 0.05 mA 0.05 mA
Table 10-15 Type CF Applied Part Leakage Current Limits - Surgical Probes and ECG
Connections
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