SafeTrace – Medical Device Testing, Asset & Compliance Management

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Test Run: LIfepak 1000

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Asset

LIfepak 1000 (B30296)

Test Template

Lifepak 1000 - Annual Test

Performed By

David Bradley

Test Equipment Used

ECG Simulator Pro Ok

Fluke Impulse 7000 Ok

Fluke QA-ES III Ok

Select equipment used for this test run. Calibration status: OK = valid, Due Soon = within 30 days, Overdue = past due.

Test Results

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#	Step	Result
1	Device Identification Record manufacturer, model (LIFEPAK 1000), serial number, asset ID, firmware/software version, battery model/lot.
2	Visual Inspection Inspect casing, screen, buttons, speaker, connectors, battery compartment and labels. No damage, corrosion or fluid ingress.
3	Accessories Present Confirm adult pads present and in date. Confirm paediatric pads/attenuator if supplied. Confirm battery present.
4	Consumables Status Confirm pads and battery are within service life. Replace via Service Action if required (do not fail unless functional impact).
5	Engineering Setup Remove device from carry case. Disconnect pads. Prepare electrical safety analyser and defibrillator analyser.
6	Power State Declaration Select power state used for testing. Mains connection triggers full electrical safety testing.
7	Protective Earth Resistance (Mains only) Measure protective earth resistance from earth pin to exposed metal.	ohm
8	Enclosure Leakage Current (NC) (Mains only) Measure enclosure/touch leakage current under normal condition.	uA
9	Patient Leakage Current – ECG (NC) (If ECG fitted) Measure patient leakage via ECG applied parts (BF).	uA
10	Defibrillator Analyser Setup Connect LIFEPAK 1000 to calibrated defibrillator analyser set to 50 ohm load using test cable or pads.
11	Power-On Self Test Power on device. Confirm no fault codes and readiness indicator OK.
12	Speaker and Prompts Confirm voice prompts and tones are clear and audible.
13	Charge Time @ Maximum Energy Select maximum adult energy and measure charge time to ready-to-shock.	seconds
14	Delivered Energy @ 200J (50Ω) Deliver 200J shock into 50Ω and record delivered energy.	Pass range: 170 - 230 J J
15	Delivered Energy @ 300J (50Ω) Deliver 300J shock into 50Ω and record delivered energy.	Pass range: 255 - 345 J J
16	Delivered Energy @ 360J (50Ω) Deliver 360J shock into 50Ω and record delivered energy.	Pass range: 324 - 396 J J
17	Post-Shock Recovery Confirm device returns to analysis/ready state without error after shock.
18	Rhythm Simulator Setup Prepare rhythm simulator for VF, pVT, Asystole and NSR waveforms.
19	Rhythm Analysis – VF Simulate ventricular fibrillation. Confirm 'Shock Advised'.
20	Rhythm Analysis – pVT Simulate pulseless VT. Confirm 'Shock Advised'.
21	Rhythm Analysis – Asystole Simulate asystole. Confirm 'No Shock Advised'.
22	Rhythm Analysis – NSR Simulate normal sinus rhythm. Confirm 'No Shock Advised'.
23	CPR Prompt Interval Measure CPR interval following shock or no-shock decision.	Pass range: 0 - 2 -
24	Paediatric Setup Fit Infant/Child pads or attenuator if applicable.
25	Paediatric Energy @ 200J Selected With paediatric pads fitted, select 200J and measure delivered energy.	Pass range: 170 - 230 J J
26	Paediatric Energy Cap Verification Select maximum adult energy and confirm paediatric output does not exceed 86J nominal.	J
27	Configuration – Stacked Shocks Disabled Verify stacked shocks are OFF (single shock then CPR).
28	Configuration – CPR Time After Shock Verify CPR interval after shock is 120 seconds.	-
29	Configuration – CPR Time After No Shock Verify CPR interval after no-shock is 120 seconds.	-
30	Configuration – Pulse Check Prompt Verify pulse check prompt behaviour.
31	Final Engineering Check Reconnect pads, refit battery, clean device, ensure correct reassembly.
32	Ready for Clinical Use Confirm device operational, labelled, and safe for return to service.
33	Technician Comments Record advisories, service actions performed, parts replaced, or deviations.