Philips Efficia DFM100 - Mechanical Assemblies

Performance Verification Procedures 5: Performance Verification
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AC Mains (Ground Leakage)
Leakage through earth (ground) wire of AC power cord.
• Normal Condition (Open ground), both AC line connections intact
–Should be <
300 A (UL, 120 VAC).
–Should be <
500 A (IEC 240 VAC).
– Record as “bbb”.
• Single Fault Condition (Open ground line, open neutral line), one AC line connection open
–Should be <
1000 A. Record as “cccc”.
Chassis (Enclosure) Leakage
Use ECG Out (Sync) jack to measure enclosure leakage current. (This is not earth ground.)
•Normal Condition
– Should be <100 A. Record as “dd”.
• Single Fault condition (Open neutral)
– Should be <300 A (UL)
– Should be <500 A (IEC)
– Record as “eee”.
Patient Lead Leakage
Leakage out of (Source) or into (Sink) patient-connected inputs (Applied Parts).
CAUTION: Do not touch the leads during this test.
ECG leads (IEC Type CF)
• Source (out of leads into Efficia DFM100)
– Normal Condition (both AC line connections and earth ground intact)
Should be <
10 A. Record as “ff ”.
– Single Fault Condition (separately open neutral and open earth, each in turn)
Should be <
50 A. Record as “gg”.
• Sink (Out of Efficia DFM100 into leads)
– Single Fault Condition is with AC Mains voltage on Applied Parts (both AC line connections
and earth ground intact)
Should be <
50 A. Record as “hh”.
Internal Paddles/pads (IEC type CF)
NOTE: Test internal paddles only if the device is used in internal defibrillation.
• Source (Out of leads into Efficia DFM100)
– Normal Condition (both AC line connections and earth ground intact)
Should be <
10 A. Record as “ii”.
– Single Fault Condition (separately open neutral and open earth, each in turn)
Should be < 50 A. Record as “jj”.
• Sink (out of Efficia DFM100 into leads)