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Test and Inspection Matrix
Table 2-1 Performance Verification and Safety Tests (Continued)
Test Group Name
Indicate test results as
Safety Tests
follows:
Earth Leakage Current NC
Earth Leakage
(Normal Condition)
Current (S1)
(Required only
when AC Power
module is used.)
Earth Leakage SF
(Single Fault - open neutral)
Patient Lead
Leakage (S3)
(Required only
when AC Power
module is used.)
ECG Patient Cable
• Source
(Normal Condition) - aa
• Source (Single Fault
Condition - open earth,
open neutral) - bb
• With Mains on applied part
(Single Fault condition) - cc
SPO
• Source
(Normal Condition) - dd
• Source (Single Fault
Condition - open earth,
open neutral) - ee
With Mains on applied part
(Single Fault condition) - ff
2-6
Test or Inspection to
Perform
2
Expected Test Results
Note: All Safety tests include
both Normal and Reverse
Polarity conditions.
If NC maximum leakage
current:
< 300 uA (UL), <500 uA
and
If SF maximum leakage
current:
< 1000 uA
then S1 test passes
If readings are as expected:
• < 10 uA
• < 50 uA
• < 50 uA
then Safety Patient Lead
Leakage test passes
If readings are as expected:
• < 10 uA
• < 50 uA
• < 50 uA
then Safety Patient SPO2
Leakage test passes.
Performance Verification and Safety Tests
Data to Record
P (pass) or F (fail)
Example: S1:p/200/300
S3:p/aa/bb/cc/dd/ee/ff/ggg/
hhh/iii
Example: S3:p/9/49/49/10/
50/50/100/499/750
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