Dräger Infinity Delta Instructions For Use Manual page 560

B T D
ECHNICAL
ECG/Arrhythmia/ST Supplemental information required by AAMI EC11/13 and
IEC 60601-2-27
Respiration excitation
waveform
Noise suppression
Time to alarm for
tachycardia
Tall T-wave rejection capa-
bility
Heart rate averaging
method
Response time of heart rate
meter to change in heart
rate
Heart rate meter accuracy
and response to irregular
rhythm
Accuracy of input signal
reproduction
B-34
ATA
Square wave signal, 50 µA, 39.896 KHz
Not Applicable
Vent tachycardia 1mVpp, 206 bpm
Gain 0.5, range 3.0 to 3.5 seconds, average 3.3 seconds
Gain 1.0, range 2.9 to 3.3 seconds, average 3.2 seconds
Gain 2.0, range 2.8 to 3.5 seconds, average 3.0 seconds
Vent tachycardia 2 mVpp, 195 bpm
Gain 0.5, range 2.2 to 4.0 seconds, average 3.0 seconds
Gain 1.0, range 1.9 to 2.5 seconds, average 2.3 seconds
Gain 2.0, range 2.0 to 2.9 seconds, average 2.5 seconds
Exceeds minimum 1.2 mV T-Wave amplitude required by ANSI/AAMI
EC 13 Sect. 3.1.2.1(c) and IEC 60601-2-27 Sect 6.8.2 bb) 2).
Heart Rate is normally based on the average R-R interval calculated
over the last 10 seconds, however it updates more quickly to reflect
changes to the patient's underlying rate.
HR change from 80 to 120 bpm:
Range: [3.4 to 7.1 seconds] Average: 5.3 seconds
HR change from 80 to 40 bpm:
Range: [6.3 to 8.6 sec] Average: 7.4 seconds
Ventricular bigeminy: 80bpm
Slow alternating ventricular bigeminy: 60 bpm
Rapid alternating ventricular bigeminy: 120 bpm
Bidirectional systoles: 90 bpm
Methods A, B, C and D from AAMI EC11 were used to establish over-
all system error and frequency response.
D /D
ELTA
XL/K
ELTA APPA
VF8