A-10
pressure.
In neonatal mode, the blood pressure measurements measured with this device are in
compliance with the American National Standard for Electronic or Automated
Sphymomanometers (ANSI/AAMI SP10) in terms of mean error and standard deviation by
comparing with intra-arterial measurements (depending on the configuration) in a typical
patient population.
A.6.4 Tem p
SmarTemp™ Temperature Module
Standards Meets standards of ISO 80601-2-56
Technique Thermal resistance (use thermistor to measure temperature )
Operating mode
Adjusted mode (predictive mode)
Direct mode (monitor mode)
Measurement range
Monitor mode:25°C to 44°C (77°F to 111.2°F)
Predictive mode: 35°C to 43°C (95°F to 109.4°F)
Accuracy (Monitor mode)
25°C to 32°C (not include 32°C): ± 0.2°C
32°C to 44°C (include 32°C): ±0.1°C
or
77°F to 89.6°F (not include 89.6°F): ± 0.4°F
89.6°F to 111.2°F (include 89.6°F): ± 0.2°F
Resolution ±0.1°C or ± 0.2°F
Minimum measurement
time for accurate readings
Monitor mode: < 60 s
Predictive mode: < 20 s (typical test: < 12s )
Alarm limit Range Step
Temp High
(low limit +1)°C to 44°C
(low limit +1.8)°F to 111.2°F
0.1°C
0.2°F
Temp Low
25°C to (high limit -1) °C
77°F to (high limit -1.8)°F
Statistical Results of Clinical Investigation Data
Clinical BIAS
(Δcb)
Limits of
Agreement (LA)
Clinical
Repeatability (σr)
Oral 0.02 0.33 0.1
Axilla 0.06 0.38 0.13
Rectum -0.05 0.48 0.14
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