54
Appendix B Product Performance
B.1 External Output
1.1
Sensitivity 1V/mV,Tolerance:
±
5% or 0.5V/mV.
1.2
Impedance of External Output
≤
100
Ω
.
1.3
Output short circuit shall not damage the ECG machine.
B.2 External DC signal Input
1.4
Sensitivity 10mm/V. Tolerance:
±
5%
1.5
Input Impedance
≥
100k
Ω
1.6
Input Impedance Attenuation. By Paralleling impedance of 4700PF capacitor and 620K
Ω
is
connected to each lead electrode. When achieving the specified value, the impedance should be near
to 2.5M
Ω
, each uniform resistance should be no less than 600 k
Ω
.
1.7
Input circuit current: all input circuit currency should be less than 0.1uA
1.8
Calibration Voltage
：
1mV, tolerance
±
5%
1.9
Sensitivity
1.9.1
Sensitivity control: At least three grade: 5, 10, 20mm/mV. Tolerance
±
5% by shifting
1.9.2
Anti-polarization Voltage : Applying
±
300mV DC polarization Voltage, the tolerance of
sensitivity is
±
5%
1.9.3
Minimum testing signal: Testing the energy of deviated sine signal of 10Hz
,
20
μ
V
(summit)
1.10
Noise Level
By paralleling impedance of 0.047
μ
F capacitor and 51k
Ω
resistance which is connected between
input terminal and neutral electrode. Within the frequency range of regulation 4.2.10. The noise
level should be no more than 15
μ
V(peak to peak value)
1.11
Anti-interference
1.11.1
The CMRR of each lead should be no less than 89db
1.11.2
ECG represents 10V rejection of common mode signal on patient, according to picture 5
simulation test , each lead is connected with simulation electrode --- Skin none-balance
impedance( paralleling impedance of 51k
Ω
resistance and 0.047
μ
F capacitor) . The recording
amplitude should be less than 10mm
1.12
50Hz Anti-interference filter
≥
20dB
