AAMI EC38 pdf free download

AAMI EC38 pdf free download.Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems.
If the manufacturer claims that the AMBULATORY RECORDER is capable of recording ECG signal in the presence of implanted pacemaker pulses, the function of the EQUIPMENT shall not be adversely affected by the operation of an implanted pacemaker.
Compliance is checked by the following test:
a) Connect the EQUIPMENT to the circuit of figure 106, with the positive PATIENT ELECTRODE connection for each channel connected to P1 and the negative ELECTRODE connection for each channel, as well as the reference ELECTRODE connection, to P2.
c) Record at least 30 s.
d) Reverse the positive and negative ELECTRODE connections in a) and repeat the recording.
e) Confirm on playback that for all pulses the height of the second peak of the sine wave after the pulse does not differ more than 0.2 mV from the height of the sine wave peak immediately preceding the pulse.
If the manufacturer claims that EQUIPMENT is capable of recording the activity of an implanted pacemaker, the EQUIPMENT shall produce a visible recording for pacemaker pulses with amplitudes between 2 mV and 200 mV, durations between 0.1 ms and 2.0 ms and a rise time of <100 is.
Compliance for such EQUIPMENT is checked by the following test:
Tests with four different pulses with a rise time of <100 ps shall be made: a first pulse having an amplitude of 2 mV and a duration of 2.0 ms, a second pulse having an amplitude of 200 mV and a duration of 2.0 ms, a third pulse having an amplitude of 20 mV and a duration of 0.1 ms and a fourth pulse having an amplitude of 2 m V and a duration of 0.1 ms.
Record at least 30 s with the sinusoidal generator settings of item b) above and a repetition rate of the pulses of 100/mm and verify that for every pulse, a mark at least 2 mm high is printed on the hard copy record at the same repetition frequency and same inter-pulse interval as the pulses input into the EQUIPMENT.
Testing shall be performed using four different pacemaker pulse wave forms: the first pulse
having an amplitude of 250 mV and a duration of 2.0 ms, a second pulse having an amplitude of
250 mV and a duration of 0.1 ms, a third pulse having an amplitude of 2.0 mV and a duration of
2.0 ms and a fourth pulse having an amplitude of 2.0 mV and a duration of 0. 1 ms.
a) Connect the EQUIPMENT to the circuit of figure 106, with the positive PATIENT ELECTRODE connection for each channel connected to P1 and the negative ELECTRODE connection for each channel, as well as the reference ELECTRODE connection, to P2.
c) Record at least 30 s
d) Reverse the positive and negative ELECTRODE connections in (a) and repeat the recording.
e) Reduce the pulse width to 0. 1 ± 0.01 ms, and record at least 30 s of this test waveform.
h) Record at least 30 S
I) Reverse the positive and negative ELECTRODE connections in (g) and repeat the recording.
j) Reduce the pulse width to 0. 1 ± 0.01 ms, and record at least 30 s of this test waveform.AAMI EC38  pdf download.