Leakage Current Limits - GE Voluson i BT06 Service Manual

GE
D KTI106052, R
IRECTION
10-7-2

Leakage Current Limits

The following acceptance limits and test conditions are summarized from IEC60601 including national
deviations and IEC 62353 and in some cases are lower than that specified by the standards. In
accordance with these standards, fault conditions like Reverse Polarity of the supply mains and Open
Neutral are no longer required for field evaluation of leakage current. Because the main source of
leakage current is the mains supply, there are different acceptance limits depending on the
configuration of the mains (100-120VAC or 230-240VAC).
Table 10-10 Leakage Current Limits for Operation on 100-120 Volt Mains (US/Canada/Japan)
Leakage Current Test
Chassis/Enclosure Leakage
Type BF Applied Parts
Type CF Applied Parts
Type CF Applied Parts (sink leakage)
Table 10-11 Leakage Current Limits for System Operation on 230-240 Volt Mains
Leakage Current Test
Chassis/Enclosure Leakage
Type BF Applied Parts
Type CF Applied Parts
Type CF Applied Parts (sink leakage)
Table 10-12 ISO (on Dale 600) and Mains Applied (on Dale 601) Limits*
* ISO (on Dale 600) and Mains Applied (on Dale 601) refer 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.
Table 10-13 Equipment Type and Test Definitions
Applied Parts (AP)
Type BF
Type CF
Sink Leakage
10
EVISION
Probe Type
BF
CF
Parts or accessories that contact the patient to perform their function.
For ultrasound equipment, this includes transducers and ECG leads.
Body Floating or non-conductive ultrasound probes which are
marked with the 'man in box' BF symbol. This includes all
transducers.
Cardiac Floating or non-conductive intraoperative probes for direct
cardiac contact and isolated ECG connections so marked with the
'heart in box' CF symbol.
The current resulting from the application of mains voltage to the applied part.
This test is required test for Type CF applied parts.
Chapter 10 - Care & Maintenance
System Power Grounding/PE Conductor Limit mA
On and Off
On (transmit)
On (transmit)
On and Off
System Power Grounding/PE Conductor Limit mA
On
On (transmit)
On (transmit)
On and Off
Measurement
5 mA
0.05 mA
V
OLUSON
S
ERVICE
Open
Closed
Open
Closed 0.01
Open 0.05
Closed 0.05
Open and Closed
Open
Open 0.05
Closed 0.05
i / V e
OLUSON
M
ANUAL
0.3
0.1
0.5
0.5
0.5
10-13