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ECG device performance testing according to international standards

Version 1.0

Raus-Jarzabek, Elzbieta; Czerw, Marek; Skowronek, Andrzej; Jamro, Ernest; Olejarczyk, Elzbieta, 2025, "ECG device performance testing according to international standards", https://doi.org/10.18150/AF0RPK, RepOD, V1

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Description

In order to establish the conformity of the ADS1298ECGFE-PDK device with the ECG standard PN-EN 60601-2-25 p. 201, the following measurements were carried out:

1.Input impedance (12.4.103) (should be greater than 2.5 MΩ) - files 13111-13119 and 13121-13129.

2.ECG path sensitivity (12.4.104) (should be changed stepwise with an accuracy of 5% in the presence of differential and common voltage of ±300 mV) - files 14111-14119.

3.Resistance to overdrive (12.4.105.2)(differential voltage of 1 V for 10 s) - files 41111-41119 and 42111-42119.

4.Noise level (12.4.106.1)(at with only the mains filter switched on, should not exceed 30 uV) - files 91110-91119.

5.Channel crosstalk (12.4.106.2)(should not exceed an amplitude of 0.5 mm at normal sensitivity, i.e., 2% of the amplitude of the given signal multiplied by the set sensitivity) - files 61111-61119.

6. Frequency response (12.4.107.1)(in the frequency range up to 150 Hz) - high frequency (A): files 15111-15119, 15121-15129 and 24111-24119; high frequency (E): files 21111-21119 and 21211-21219; low frequency: files 22111-22119.

7. Linearity and range of transfer (12.4.107.2)(should be ensured in each lead for 20 mV with an accuracy of 5% over the entire width of the recording field, also in the presence of a common or differential voltage of 300 mV of any polarity) - files 101111-101119.

Subject

Engineering

Keyword

ECG device, ADS1298 analog front-end, performance testing, international ECG standards, 60601-2-25, 60601-2-27, 60601-2-47

License

CC0 Creative Commons Zero 1.0

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		Device_13111_Volts.txt Plain Text - 1.0 MB - Jul 21, 2025 - 1 Download MD5: 6d76d088b4809b07db1b736bb1a46b3b License: CC0 Creative Commons Zero 1.0	Preview Download
		Device_13112_Volts.txt Plain Text - 1.0 MB - Jul 21, 2025 - 1 Download MD5: 86ec7370722ea261b239d55cce5b6b5b License: CC0 Creative Commons Zero 1.0	Preview Download
		Device_13113_Volts.txt Plain Text - 1.0 MB - Jul 21, 2025 - 1 Download MD5: a5fd5796ebace32cc308753e9d6ba83e License: CC0 Creative Commons Zero 1.0	Preview Download
		Device_13114_Volts.txt Plain Text - 1.1 MB - Jul 21, 2025 - 1 Download MD5: bddd98c14e962e4a6de91b299d6c4e25 License: CC0 Creative Commons Zero 1.0	Preview Download
		Device_13115_Volts.txt Plain Text - 1.1 MB - Jul 21, 2025 - 1 Download MD5: 01da338b33bb2b76390b833f830d9c6d License: CC0 Creative Commons Zero 1.0	Preview Download
		Device_13116_Volts.txt Plain Text - 1.1 MB - Jul 21, 2025 - 1 Download MD5: e9a5b6f63e0b9bd5210507312d817a9b License: CC0 Creative Commons Zero 1.0	Preview Download
		Device_13117_Volts.txt Plain Text - 1.1 MB - Jul 21, 2025 - 1 Download MD5: 9565ede55632d171064b33260ab78b81 License: CC0 Creative Commons Zero 1.0	Preview Download
		Device_13118_Volts.txt Plain Text - 1.1 MB - Jul 21, 2025 - 1 Download MD5: db2a49fd30c05deaede36eeb382c6500 License: CC0 Creative Commons Zero 1.0	Preview Download
		Device_13119_Volts.txt Plain Text - 1.1 MB - Jul 21, 2025 - 1 Download MD5: 8bb3fdf64a36ebd1a16d1c54fdf18493 License: CC0 Creative Commons Zero 1.0	Preview Download
		Device_13121_Volts.txt Plain Text - 1.0 MB - Jul 21, 2025 - 1 Download MD5: 78c79493b2db124cf3083da89fba694e License: CC0 Creative Commons Zero 1.0	Preview Download

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