Dräger Infinity Delta, Instructions For Use Manual

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B-34 D
ELTA
/D
ELTA
XL/K
APPA
VF8
B T
ECHNICAL
D
ATA
ECG/Arrhythmia/ST Supplemental information required by AAMI EC11/13 and
IEC 60601-2-27
Respiration excitation
waveform Square wave signal, 50 µA, 39.896 KHz
Noise suppression Not Applicable
Time to alarm for
tachycardia 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
Tall T-wave rejection capa-
bility 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 averaging
method 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.
Response time of heart rate
meter to change in heart
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
Heart rate meter accuracy
and response to irregular
rhythm Ventricular bigeminy: 80bpm
Slow alternating ventricular bigeminy: 60 bpm
Rapid alternating ventricular bigeminy: 120 bpm
Bidirectional systoles: 90 bpm
Accuracy of input signal
reproduction Methods A, B, C and D from AAMI EC11 were used to establish over-
all system error and frequency response.