Leakage Current Limits - GE LOGIQ E9 Service Manual

GE
D 5573152-100, R
IRECTION
10-7-3

Leakage Current Limits

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 (100-120 or 230-240).
Per IEC 60601-1 section 4.7
Single fault Condition for Medical Equipment (ME EQUIPMENT) shall be so designed and
manufactured that it remains SINGLE FAULT SAFE, or the RISK remains acceptable as determined
through application of 4.2.
-
Compare all safety-test results with safety-test results of previously performed safety tests (e.g.
CAUTION
last year etc). In case of unexplainable abrupt changes of safety-test results consult
experienced authorized service personnel or GE for further analysis.
Table 10-9
Chassis/Enclosure Leakage
Type BF Applied Parts
Type CF Applied Parts
Type BF Applied Parts (sink leakage, mains
voltage on applied part)
Type CF Applied Parts (sink leakage)
(1) UL standard
Table 10-10 Leakage current limits for Ultrasound system operation on 230-240 Volt mains
Chassis/Enclosure Leakages
Type BF Applied Parts
Type CF Applied Parts
Type BF Applied Parts (sink leakage, mains
voltage on applied part)
Type CF Applied Parts (sink leakage)
(2) IEC60601 Second Edition
(3) IEC60601 Third Edition
10 - 14
. 2
EV
Sub clause 4.7 – SINGLE FAULT CONDTION for ME EQUIPMENT.
Leakage current limits for Ultrasound system operation on 100-120 Volt mains
(US/Canada/Japan)
Leakage Current Test
Leakage Current Test
Section 10-7 - Electrical Safety Tests
System Grounding/PE
Power Conductor
On and Off
Closed
On (transmit)
Closed
On (transmit)
On and Off Closed
On and Off Closed
System Ground/PE
Power Conductor
On Open and Closed
Closed
On (transmit)
Closed
On (transmit)
On and Off Closed
On and Off Closed
LOGIQ E9 S
ERVICE
Limit in mA (1)
Open
Open
Open
Limit in
mA (2)
0.5
0.1
Open 0.5
0.01
Open 0.05
5
0.05
M
ANUAL
0.3
0.1
0.5
0.01
0.05
5
0.05
Limit in
µA (3)
500
100
500
10
50
5000
50