Medlab medizinische Diagnosegeräte GmbH EG01010 User Manual
Version 1.06
8 9
Technical Description for TRF EN 60601-2-27
When preparing a test report form (TRF) for proof of compliance of the user's medical product to EN
60601-2-27, the following remarks / technical data will be helpful or needed:
Input Impedance: > 10 MOhm
Common mode rejection ratio: > 90 dB at 50 Hz or 60 Hz
Input Dynamic Range: ±5 mV AC, ±300 mV DC
Defibrillator Discharge Recovery: <10 sec per IEC 601-2-27
<10 sec per AAMI EC13-1992
Leads-off sensing current: Applied currents less than 150 nA
The following information references particular sections of EN 601-2-27
Respiration (optional), section 201.7.9.2.9.101 b) 1)
Applied currents less than 80 µA @ 80 kHz square
Tall T-wave rejection, section 201.9.2.9.101 b) 2)
T-wave of 1.1 mV amplitude will not affect heart rate determination.
Heart rate averaging, section 201.7.9.2.9.101 b) 3)
TBD
Response to irregular rhythm, section 201.7.9.2.9.101 b) 4)
A1) Ventricular bigeminy: the EG01010 counts both large and small QRS complexes to display a rate of
80 bpm.
A2) Slow alternating ventricular bigeminy: the EG01010 counts both large and small QRS complexes to
display a rate of 60 bpm.
A3) Rapid alternating ventricular bigeminy: the EG01010 counts all QRS complexes to display a rate of
120 bpm.
A4) Bi-directional systoles: the EG01010 counts all QRS complexes to display a rate of 90 bpm.
Heart rate meter response time, section 201.7.9.2.9.101 b) 5)
a) Change from 80 to 120 BPM: 4 sec
b) Change from 80 to 40 BPM: 7 sec
Time to alarm for tachycardia, section 201.7.9.2.9.101 b) 6)
Waveform B1: Amplitude Time to alarm
0,5 mV 1 sec
1 mV 1 sec
2 mV 1 sec
Waveform B2 Amplitude Time to alarm
1 mV 1 sec
2 mV 1 sec
4 mV 1 sec
Pacemaker pulse display capability, section 201.12.1.101.12
The EG01010 is capable of displaying the ECG signal in the presence of
pacemaker pulses with amplitudes of ± 2 mV to ± 700 mV and durations of
0.1 ms to 2.0 ms. An indication for the pacemaker pulse is provided.
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