SafeTrace – Medical Device Testing, Asset & Compliance Management

Template Steps

Defibrillator Functional – IEC 60601-2-4

v1.0 | 2025-10-02 10:02Published

Test Steps

#	Title	Type	Limits	Unit	Actions
1	Visual Inspection Inspect casing, leads, electrodes, controls, and labels for integrity.	BooleanCheck	-	-	Locked
2	Protective Earth Continuity Measure resistance from earth pin to accessible conductive parts.	NumericMeasure	-	Ω	Locked
3	Enclosure Leakage Current (NC) Measure enclosure leakage in normal condition.	NumericMeasure	-	µA	Locked
4	Enclosure Leakage Current (SFC) Apply single fault condition per test regime and measure leakage.	NumericMeasure	-	µA	Locked
5	Applied-Part Leakage (NC) Measure patient/applied-part leakage in normal condition.	NumericMeasure	-	µA	Locked
6	Applied-Part Leakage (SFC) Simulate single fault condition (e.g., open PE) and measure leakage.	NumericMeasure	-	µA	Locked
7	Insulation Resistance Measure insulation resistance between mains and applied parts.	NumericMeasure	-	MΩ	Locked
8	Delivered Energy @ 200 J Charge to 200 J and discharge into analyzer; record delivered energy.	NumericMeasure	169 - 231 J	J	Locked
9	Delivered Energy @ Maximum Charge to maximum selectable energy (e.g., 360 J) and verify delivered energy.	NumericMeasure	305 - 415 J	J	Locked
10	Charge Time @ 200 J Measure time to charge to 200 J.	NumericMeasure	-	s	Locked
11	Charge Time @ Maximum Measure time to charge to maximum energy (e.g., 360 J).	NumericMeasure	-	s	Locked
12	Charge Cancel / Disarm Verify charge cancellation and safe disarm into the load.	BooleanCheck	-	-	Locked
13	Sync Function (R-Wave Delay) Verify synchronisation to R-wave; measure sync delay.	NumericMeasure	-	ms	Locked
14	Energy Accuracy Across Loads Verify delivered energy remains within tolerance across 25–175 Ω loads.	BooleanCheck	-	-	Locked
15	Maximum Energy Verification Confirm maximum selectable energy output meets tolerance across specified loads.	BooleanCheck	-	-	Locked
16	Defibrillator Proof Test Verify device withstands defibrillator proof test pulses as specified.	BooleanCheck	-	-	Locked
17	Pacing Output Current (if equipped) Set nominal pacing current and measure output.	NumericMeasure	-	mA	Locked
18	Pacing Rate Accuracy (if equipped) Set pacing rate (e.g., 60 bpm) and verify measured rate.	NumericMeasure	-	bpm	Locked
19	ECG Display Calibration Verify ECG amplitude calibration using a standard calibration signal.	NumericMeasure	-	mV	Locked
20	Heart Rate Accuracy Simulate ECG at known rates and verify displayed heart rate.	NumericMeasure	-	bpm	Locked
21	Arrhythmia Detection Simulate VF/VT/asystole/brady/tachy and verify correct detection/alarms.	BooleanCheck	-	-	Locked
22	Alarm Functionality Verify audible/visual alarms activate appropriately for critical conditions.	BooleanCheck	-	-	Locked
23	Impedance / Lead-Off Detection Verify patient impedance checks and lead-off detection operate correctly.	BooleanCheck	-	-	Locked
24	Battery Performance Verify charge/discharge behaviour and runtime under load per manufacturer spec.	BooleanCheck	-	-	Locked
25	Data Logging / Printer Output Verify event logs and printed outputs are complete and accurate.	BooleanCheck	-	-	Locked