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Test Run Details
Test Run Information
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Test Results
Export PDF Report| # | Step | Type | Result | Pass/Fail | Comment |
|---|---|---|---|---|---|
| 1 | Device Identification Record manufacturer, model (LIFEPAK 1000), serial number, asset ID, firmware/software version, battery model/lot. IEC 62353 |
Text Note | - | - | - |
| 2 | Visual Inspection Inspect casing, screen, buttons, speaker, connectors, battery compartment and labels. No damage, corrosion or fluid ingress. IEC 62353 §4.2 |
Yes/No Check | - | - | - |
| 3 | Accessories Present Confirm adult pads present and in date. Confirm paediatric pads/attenuator if supplied. Confirm battery present. Manufacturer |
Yes/No Check | - | - | - |
| 4 | Consumables Status Confirm pads and battery are within service life. Replace via Service Action if required (do not fail unless functional impact). Service Policy |
Yes/No Check | - | - | - |
| 5 | Engineering Setup Remove device from carry case. Disconnect pads. Prepare electrical safety analyser and defibrillator analyser. Engineering |
Instruction | - | - | - |
| 6 | Power State Declaration Select power state used for testing. Mains connection triggers full electrical safety testing. Expected:{"Value":"Mains connected"}}" |
Multiple Choice | - | - | - |
| 7 | Protective Earth Resistance (Mains only) Measure protective earth resistance from earth pin to exposed metal. IEC 62353 / IEC 60601-1 |
Measurement | - | - | - |
| 8 | Enclosure Leakage Current (NC) (Mains only) Measure enclosure/touch leakage current under normal condition. IEC 62353 |
Measurement | - | - | - |
| 9 | Patient Leakage Current – ECG (NC) (If ECG fitted) Measure patient leakage via ECG applied parts (BF). IEC 62353 |
Measurement | - | - | - |
| 10 | Defibrillator Analyser Setup Connect LIFEPAK 1000 to calibrated defibrillator analyser set to 50 ohm load using test cable or pads. IEC 60601-2-4 |
Instruction | - | - | - |
| 11 | Power-On Self Test Power on device. Confirm no fault codes and readiness indicator OK. Manufacturer |
Yes/No Check | - | - | - |
| 12 | Speaker and Prompts Confirm voice prompts and tones are clear and audible. Manufacturer |
Yes/No Check | - | - | - |
| 13 | Charge Time @ Maximum Energy Select maximum adult energy and measure charge time to ready-to-shock. IEC 60601-2-4 |
Measurement | - | - | - |
| 14 | Delivered Energy @ 200J (50Ω) Deliver 200J shock into 50Ω and record delivered energy. J |
Measurement | - | - | - |
| 15 | Delivered Energy @ 300J (50Ω) Deliver 300J shock into 50Ω and record delivered energy. J |
Measurement | - | - | - |
| 16 | Delivered Energy @ 360J (50Ω) Deliver 360J shock into 50Ω and record delivered energy. J |
Measurement | - | - | - |
| 17 | Post-Shock Recovery Confirm device returns to analysis/ready state without error after shock. IEC 60601-2-4 |
Yes/No Check | - | - | - |
| 18 | Rhythm Simulator Setup Prepare rhythm simulator for VF, pVT, Asystole and NSR waveforms. IEC 60601-2-4 |
Instruction | - | - | - |
| 19 | Rhythm Analysis – VF Simulate ventricular fibrillation. Confirm 'Shock Advised'. IEC 60601-2-4 |
Yes/No Check | - | - | - |
| 20 | Rhythm Analysis – pVT Simulate pulseless VT. Confirm 'Shock Advised'. IEC 60601-2-4 |
Yes/No Check | - | - | - |
| 21 | Rhythm Analysis – Asystole Simulate asystole. Confirm 'No Shock Advised'. IEC 60601-2-4 |
Yes/No Check | - | - | - |
| 22 | Rhythm Analysis – NSR Simulate normal sinus rhythm. Confirm 'No Shock Advised'. IEC 60601-2-4 |
Yes/No Check | - | - | - |
| 23 | CPR Prompt Interval Measure CPR interval following shock or no-shock decision. seconds |
Measurement | - | - | - |
| 24 | Paediatric Setup Fit Infant/Child pads or attenuator if applicable. IEC 60601-2-4 |
Instruction | - | - | - |
| 25 | Paediatric Energy @ 200J Selected With paediatric pads fitted, select 200J and measure delivered energy. Limits:{"Max":86}}" |
Measurement | - | - | - |
| 26 | Paediatric Energy Cap Verification Select maximum adult energy and confirm paediatric output does not exceed 86J nominal. J |
Measurement | - | - | - |
| 27 | Configuration – Stacked Shocks Disabled Verify stacked shocks are OFF (single shock then CPR). AHA / Manufacturer |
Yes/No Check | - | - | - |
| 28 | Configuration – CPR Time After Shock Verify CPR interval after shock is 120 seconds. seconds |
Measurement | - | - | - |
| 29 | Configuration – CPR Time After No Shock Verify CPR interval after no-shock is 120 seconds. seconds |
Measurement | - | - | - |
| 30 | Configuration – Pulse Check Prompt Verify pulse check prompt behaviour. ALWAYS] |
Multiple Choice | - | - | - |
| 31 | Final Engineering Check Reconnect pads, refit battery, clean device, ensure correct reassembly. Engineering |
Instruction | - | - | - |
| 32 | Ready for Clinical Use Confirm device operational, labelled, and safe for return to service. Service Release |
Yes/No Check | - | - | - |
| 33 | Technician Comments Record advisories, service actions performed, parts replaced, or deviations. Quality Record |
Text Note | - | - | - |