Performance Verification Procedures 5: Performance Verification
173
Chassis (Enclosure) Leakage
Use ECG Out (Sync) jack to measure enclosure leakage current. (This is not earth ground.)
•Normal Condition
–Should be <
100 μA. Record as “cc”.
• Single Fault condition (Open neutral)
–Should be <
300 μA (UL)
–Should be <
500 μA (IEC)
–Record as “dd”.
Patient Lead Leakage
Leakage out of (Source) or into (Sink) patient-connected inputs (Applied Parts).
When performing the leakage test on the Therapy Port, only one style cable needs to be tested. If the
customer uses internal paddles, then the Internal Paddles test should be performed (note: use CF limits).
If the device is not used for internal defibrillation such as in the pre-hospital market, then either external
paddles or pads cable (whichever is available) can be used to test the leakage current (note: use BF limits).
CAUTION: Do not touch the leads during these tests.
ECG leads (IEC Type CF)
• Source (out of leads into HeartStart XL+)
– Normal Condition (both AC line connections and earth ground intact)
Should be <
10 μA. Record as “eee”.
– Single Fault Condition (separately open neutral and open earth, each in turn)
Should be <
50 μA. Record as “fff ”.
• Sink (out of HeartStart XL+ into leads)
– Single Fault Condition is with AC Mains voltage on Applied Parts (both AC line connections
and earth ground intact)
Should be <
50 μA. Record as “ggg”.
External Paddles/Pads (IEC type BF)
•Source:
– Normal Condition (both AC line connections and earth ground intact)
Should be <
100 μA. Record as “hhh”.
– Single Fault Condition (separately open neutral and open earth, each in turn)
Should be <
500 μA. Record as “iii”.
•Sink
– Single Fault Condition (with AC Mains voltage on Applied Parts)
(both AC line connections and earth ground intact)
Should be <
500 μA. Record as “jjj”.
To Next Page
Loading...
