Shenzhen Comen Medical Instruments co., ltd.
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Chapter 5 Performance Verification
5.1 Safety Test
Safety tests should be performed by qualified personnel every 6 to 12 months, and each time after
service use a standard safety tester to perform safety tests. The tester must comply with IEC/EN
60601-1or the local standards and statutes.
Refer to the accompanying operation instructions of the tester for test procedure details.
5.2 Performance Tests
The performance test should be done once every 12 months or when you suspect the
measurement is incorrect.
5.2.1 ECG Performance test
Patient cables include two parts: main cables which are connected to the electrocardiograph and
the lead wires which are connected to the patient. Lead wires include 6 chest lead wires and
4limbs lead wires, the user can distinguish the chest leads and limb leads from the color of the
lead wires and the label on the connector.
Required Equipment: ECG Simulator
1) Connect the leadcable and electrocardiograph as show below:
2)Connect the leadcable and the simulator as shown below:
3) Switch on the electrocardiograph.
4) Generate the heart rate 40 bpm, 80 bpm, 120 bpm, 160 bpm, 200 bpm and 240 bpm in turn.
5) Check if the HR value displayed on the screen is accurate. Error within 2 bpm is acceptable.
5.2.2 Print speed test
5.2.2.1 Standard request.
Enterprise standard：with 5 kinds of print speed 5mm/s、10mm/s、12.5 mm/s、25mm/s and
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