GE
D
IRECTION
5573152-100, R
EV
. 2
LOGIQ E9 S
ERVICE
M
ANUAL
10 - 14
Section 10-7 - Electrical Safety Tests
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.
-
Sub clause 4.7 – SINGLE FAULT CONDTION for ME EQUIPMENT.
(
1
) UL standard
(
2
) IEC60601 Second Edition
(
3
) IEC60601 Third Edition
CAUTION
Compare all safety-test results with safety-test results of previously performed safety tests (e.g.
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 Leakage current limits for Ultrasound system operation on 100-120 Volt mains
(US/Canada/Japan)
Leakage Current Test
System
Power
Grounding/PE
Conductor
Limit in mA (1)
Chassis/Enclosure Leakage
On and Off
Open
0.3
Type BF Applied Parts
On (transmit)
Closed
0.1
Open
0.5
Type CF Applied Parts
On (transmit)
Closed
0.01
Open
0.05
Type BF Applied Parts (sink leakage, mains
voltage on applied part)
On and Off
Closed
5
Type CF Applied Parts (sink leakage)
On and Off
Closed
0.05
Table 10-10 Leakage current limits for Ultrasound system operation on 230-240 Volt mains
Leakage Current Test
System
Power
Ground/PE
Conductor
Limit in
mA (2)
Limit in
µA (3)
Chassis/Enclosure Leakages
On
Open and Closed
0.5
500
Type BF Applied Parts
On (transmit)
Closed
0.1
100
Open
0.5
500
Type CF Applied Parts
On (transmit)
Closed
0.01
10
Open
0.05
50
Type BF Applied Parts (sink leakage, mains
voltage on applied part)
On and Off
Closed
5
5000
Type CF Applied Parts (sink leakage)
On and Off
Closed
0.05
50
Summary of Contents for LOGIQ E9
Page 2: ......
Page 11: ...GE DIRECTION 5573152 100 REV 2 LOGIQ E9 SERVICE MANUAL xi ZH CN KO ...
Page 753: ......
Page 754: ......
