GENERAL INFORMATION RECURRENT TEST CUSTO MED ECG DEVICES
Frequency
Once every two year and after each repair a recurrent safety test has to be performed following the EN
62353:2015.
Required tools
- Safety tester
- Adapter pins for connecting electrodes to the safety tester. Art. nr 85056.
- ECG Simulator. Recommended model: Müller & Sebastiani model MS410.
- Blind plugs for finding leaks in cables (only cardio2xx). Art.nr 3942014.
Test procedure
1. Visual inspection
Check the ECG cables and electrodes for damage. In case of damage, replace with the correct acticles.Refer to your dealer for article numbers and pricing. Check the housing for damage, especially where the device is suspended from the arm. When damaged, please send the device to your reseller for repair. Check the arm, especially the rotation stop and USB cable.
2. Electrical safety check
Perform a safety test according the NEN-EN-IEC 62353:2015. The cardio 200 is classified as Class II type BF device. To perform the safety test remove the electrodes from the end of the cables and place the adapter pins on the leadwires. Connect the adapter pins to the safety tester. It is not necessary to perform an actual recording while testing.See Appendix A for permitted values.See Appendix B for information about the norms NEN-EN-IEC 62353:2015 and NEN-EN-IEC 60601-1.
3. Accuracy of signal measurement
Use a calibrated patient simulator to perform a signal with a frequency of 1 Hz that starts with a 1mV pulse. Start custo diagnostic and perform a resting ECG test. Disable all filters (Anti Drift filter, muscle filter, 50 Hz filter) in the settings. Measure the heart frequency and confirm the value is the same as set in the simulator.Measure the 1mV pulse at the limb channels (see screenshot). With a scaling of 10 mm/mV, the Confirm that the waveform is shown as in the screenshot.
4. Pressure leakage (only cardio2xx)
Place the electrodes back on the cardio 200 leads and start the device. The pump almost immediately should stop pumping. To keep the under pressure the pump should every now and then start pumping (normally once every 1 to 10 seconds). If there is a leak, the pump remains pumping all the time. In that case, place the blind plugs on the cardio200 and exchange them for the cables one at a time to discern the cable that causes the leakage. If there is no leak in the leads of the cardio 200 but the pump remains pumping, please send the device to your reseller for repair. If you undertake to measure the pressure yourself, the pressure should be 270 mBar +/- 5%.
5. Battery check (only cardio1xx)
Batteries age with time. The decharge curve changes over time, the quality of the battery cannot easily be measured. If the battery is empty too soon for proper use, please replace the battery with a new one.The article number is 12039/Z.
6. Exchange of filters (only cardio2xx)
There is a filter in the cardio200 that protects the pump from water accidentily being sucked up by the cables. It is not necessary to replace this filter periodically. For replacement of this filter, please send the device to your reseller.
Appendix A: permitted values
Source: NEN-EN-IEC 60601-1 (as referenced by NEN-EN-IEC 62353)
Appendix B: NEN-EN-IEC 60601-1 vs. NEN-EN-IEC 62353
Safety test on medical equipment has to be performed according the NEN-EN-IEC 60601-1 this norm applies to the basic safety and essential performance of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. This standard is indicated to be used by manufacturers of Medical electrical equipment. The standard recognizes that the laboratory conditions described in NEN-EN-IEC 60601-1 cannot always be guaranteed when in-service testing of medical devices is undertaken. As a result, test measurements that require certain environmental conditions may not always be applicable or consistent for the testing of equipment that is already in use.
The NEN-EN-IEC 62353:2015 “MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS – describes recurrent test and test after repair. echnical Considerations. The main goal of NEN-EN-IEC 62353:2015 is to provide a uniform standard that ensures safe practice and reduces the complexity of the NEN-EN-IEC 60601-1 standard. NEN-EN-IEC 62353:2015 COMPARED TO THE NEN-EN-IEC 60601-1 Besides the safety test that have to be performed according the NEN-EN-IEC 60601-1 there are some additional checks, like visual inspection of the device and cables, check of the fuse rate and quality of labelling and marking.
The main difference is the NEN-EN-IEC 62353:2015 proposes a minimum test current of 200 mA in ground bond testing instead of the 25 A required in NEN-EN-IEC 60601-1. In terms of assessing leakage currents, NEN-EN-IEC62353:2015 incorporates a number of different measurement methods to help guarantee safer practices and the repeat-ability of measurements.
- Direct Leakage Method. This is identical to the method used in IEC 60601-1 measuring the true leakage through a body model measuring device to earth. It has the highest accuracy compared to the other methods.
- Differential Leakage Method. This measures the leakage current as an imbalance in current between the live and neutral conductors. Potential secondary ground connections are included in the total measurement
- Alternative Leakage Method. The device under Test (DUT) in not connected to the mains supply. This method provides the safest possible test conditions for the operator. This measurement is only taken in a single polarity and is similar to a dielectric test at mains potential using a current-limited mains-frequency supply.