GE
DRAFT
V
OLUSON
™ P8 / V
OLUSON
™ P6
DIRECTION 5723243, R
EVISION
6
DRAFT (M
AY
23, 2018)
B
ASIC
S
ERVICE
M
ANUAL
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***