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Philips IntelliVue MX40 Instructions For Use Manual Page 185

Wearable patient monitor.
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Characteristic
Heart Rate Meter Accuracy and
Response to Irregular Rhythm
Response Time of Heart Rate Meter to
Change in Heart Rate
Time to Alarm for Tachycardia
Pacemaker Pulse Rejection Capability
Range and Accuracy of Heart Rate
Meter
Alarm Limit Range
Resolution of Alarm Limit Settings
Alarm Limit Accuracy
Time to Alarm for Cardiac Standstill
Time to Alarm for Low Heart Rate
Time to Alarm for High Heart Rate
Alarm Silencing
ECG Waveform Display Time Base
Accuracy
Performance Disclosure/Specification (in italics)
Provides correct heart rates (80, 60, 120, 90 b/min)
using test waveforms as indicated in ANSI/AAMI EC13
Sec. 3. 1. 2. 1 (5).
For a rate increase, the average time to reach the
specified heart rate using test waveforms as indicated in
ANSI/AAMI EC13 Sec. 3. 1. 2. 1 (6) is 8.6 seconds. For
a rate drop, the average time is 8.2 seconds.
The ranges of time to alarm using test waveforms as
indicated in ANSI/AAMI EC13 Sec. 3. 1. 2. 1 (7) are 6.4
to 9.3 seconds.
Rejects pace pulses using test waveforms as indicated
in ANSI/AAMI EC13 Sec. 3. 1. 4 (with amplitude from
+/- 2 to +/- 700 mV, width from 0.1 to 2.0 ms).
Meets the ANSI/AAMI EC13 Section 3.2.7
recommended minimum range and accuracy.
Heart rate range is 15 - 300 b/min with accuracy of
1% of the range for Adult and Pediatric patients. (Note:
for rates equal to or less than 15, the displayed heart
rate is 0).
Meets the ANSI/AAMI EC13 Section 3.2.8.1 standard.
Lower alarm limit is 15 -295. Upper alarm limit is 20 -
300.
Meets the ANSI/AAMI EC13 Section 3.2.8.2 standard.
The resolution is
5 b/min.
Meets the ANSI/AAMI EC13 Section 3.2.8.3 standard.
Error less than ± 10% or ± 5b/min
Meets the ANSI/AAMI EC13 Section 3.2.8.4 standard:
maximum alarm time <10 seconds, using the test
waveforms as indicated.
Meets the ANSI/AAMI EC13 Section 3.2.8.5 standard:
maximum alarm time <10 seconds, using the test
waveforms as indicated.
Meets the ANSI/AAMI EC13 Section 3.2.8.6 standard:
maximum alarm time <10 seconds, using the test
waveforms as indicated.
The time required for reactivation of a latched, silenced
alarm is 3 minutes
0.8%. Meets the ANSI/AAMI EC13 Section 3.2.9.6
standard: maximum error = +/-10%.
Safety Standards & Specifications
13-23

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