GE Voluson P6 - 10-8-2 GEHC Leakage Current Limits for Voluson P8;VolusonP6

GE DRAFT VOLUSON™ P8/VOLUSON™P6
DIRECTION 5775469, R
EVISION 3 DRAFT (JULY 19, 2018) BASIC SERVICE MANUAL
Chapter 10 - Care & Maintenance 10-15
10-8-2 GEHC Leakage Current Limits for Voluson™ P8/Voluson™P6
The following limits are summarized for IEC60601-1 standard including national deviations and IEC
62353 Medical Electrical Equipment - Recurrent test and test after repair of medical electrical
equipment.
Measurement limits per IEC60601-1 standard including national deviations.
Table 10-17 Type CF Patient Leakage Limits - ECG leads
Table 10-14 Enclosure Leakage Current Limits -Accessible Surfaces not protectively earthed
Conditions
Country
USA Others
Close Protective earth and close neutral with normal polarity 0.1 mA* 0.1 mA***
Close Protective earth and close neutral with reverse polarity 0.1 mA* 0.1 mA***
Open Protective earth and close neutral with normal polarity 0.3 mA** 0.5 mA***
Open Protective earth and close neutral with reverse polarity 0.3 mA** 0.5 mA***
Open neutral and close Protective earth with normal polarity 0.5 mA* 0.5 mA***
Open neutral and close Protective earth with reverse polarity 0.5 mA* 0.5 mA***
Table 10-15 Earth Leakage Current Limits
Conditions
Country
USA Others
Close Protective earth and close neutral with normal polarity 0.3 mA** 0.5 mA***
Close Protective earth and close neutral with reverse polarity 0.3 mA** 0.5 mA***
Open neutral and close Protective earth with normal polarity 1 mA* 1 mA***
Open neutral and close Protective earth with reverse polarity 1 mA* 1 mA***
Table 10-16 Type BF Patient Leakage Limits - Non-Conductive Surface
Conditions
Country
USA Others
Close Protective earth and close neutral with normal polarity 0.1 mA* 0.1 mA***
Close Protective earth and close neutral with reverse polarity 0.1 mA* 0.1 mA***
Open Protective earth and close neutral with normal polarity 0.5 mA* 0.5 mA***
Open Protective earth and close neutral with reverse polarity 0.5 mA* 0.5 mA***
Open neutral and close Protective earth with normal polarity 0.5 mA* 0.5 mA***
Open neutral and close Protective earth with reverse polarity 0.5 mA* 0.5 mA***
Conditions
Country
USA Others
Close Protective earth and close neutral with normal polarity 0.01 mA* 0.01 mA***