5: Performance Verification Performance Verification Procedures
176
Leakage Currents
Refer to Figure 133 “Efficia DFM100 Leakage Current Test Diagram” on page 170.
NOTE: ˙ Check accessible conductive parts for touch current (enclosure leakage current), but not for protective
earth resistance because they are not protectively earthed.
AC Mains (Ground Leakage)
Leakage through earth (ground) wire of AC power cord.
• Normal Condition (Open ground), both AC line connections intact
–Should be <
1000 A.
Chassis (Enclosure) Leakage
Use ECG Out (Sync) jack to measure enclosure leakage current. (This is not earth ground.)
•Normal Condition
–Should be <
100 A.
Patient Lead Leakage
Leakage out of (Source) or into (Sink) patient-connected inputs (Applied Parts).
ECG leads (IEC Type CF)
• Source (out of leads into Efficia DFM100)
– Normal Condition (both AC line connections and earth ground intact)
Should be < 50 A.
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 <
100A.
External Paddles/Pads (IEC type BF)
•Source:
– Normal Condition (both AC line connections and earth ground intact)
Should be <
5000 A.