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User's Manual

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Measurement Specifications
15-28 Safety Standards & Specifications
Characteristic
Performance Disclosure/Specification (in
italics)
Time to Alarm for Tachycardia
The ranges of time to alarm using test waveforms as
indicated in ANSI/AAMI EC13 Sec. 4 1. 2. 1 (g) are 4 to 5
seconds.
Pacemaker Pulse Rejection Capability
Rejects pace pulses using test waveforms as indicated in
ANSI/AAMI EC13 Sec. 4. 1. 4.1 (with amplitude from +/- 2
to +/- 700 mV, width from 0.1 to 2.0 ms).
Range and Accuracy of Heart Rate Meter
Meets the ANSI/AAMI EC13 Section 4.2.7 recommended
minimum range and accuracy.
Heart rate range is 15 - 300 b/min for adults patients and
15-350 b/min for pediatric patients with accuracy of 1% of
the range. (Note: for rates equal to or less than 15, the
displayed heart rate is 0).
Alarm Limit Range
Meets the ANSI/AAMI EC13 Section 4.2.8.1 standard.
Lower alarm limit is 15 -295. Upper alarm limit is 20 - 300.
Resolution of Alarm Limit Settings
Meets the ANSI/AAMI EC13 Section 4.2.8.2 standard. The
resolution is 5 b/min.
Alarm Limit Accuracy
Meets the ANSI/AAMI EC13 Section 4.2.8.3 standard.
Error less than ± 10% or ± 5b/min
Time to Alarm for Cardiac Standstill
Meets the ANSI/AAMI EC13 Section 4.2.8.4 standard:
maximum alarm time <10 seconds, using the test
waveforms as indicated.
Time to Alarm for Low Heart Rate
Meets the ANSI/AAMI EC13 Section 4.2.8.5 standard:
maximum alarm time <10 seconds, using the test
waveforms as indicated.
Time to Alarm for High Heart Rate
Meets the ANSI/AAMI EC13 Section 4.2.8.6 standard:
maximum alarm time <10 seconds, using the test
waveforms as indicated.
Alarm Silencing
The time required for reactivation of a latched, silenced
alarm is 3 minutes
ECG Waveform Display Time Base
Accuracy
Meets the ANSI/AAMI EC13 Section 4.2.9.6 standard:
maximum error = +/-10%.
Channel Width
Meets the ANSI/AAMI EC13 Section 4.2.9.7(a) standard:
minimum = 30mm.
Trace Width
Meets the ANSI/AAMI EC13 Section 4.2.9.7(b) standard:
maximum = 1.0mm.
Aspect Ratio
Meets the ANSI/AAMI EC13 Section 4.2.9.7(f) standard: 0.4
+ 0.08 s/mV.
Input Signal Reproduction Accuracy:
Overall Error
Meets the ANSI/AAMI EC13 Section 4.2.9.8(a) standard:
maximum = +/- 20%.
Frequency Response: Sinusoidal
Meets the ANSI/AAMI EC13 Section 4.2.9.8(b) standard:
0.67 to 40 Hz
(3 db down).