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* Measurement accuracy verification: In adult and pediatric modes, 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 or auscultatory
measurements (depending on the configuration) in a typical patient population. For
auscultatory reference, the 5
th
Korotkoff sound was used to determine the diastolic 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 Temp Specifications
A.6.4.1 Specifications of the SmarTemp™ Temperature Module
Sys High Adult: (low limit+5) to 290
Pediatric: (low limit+5) to 240
Neonate: (low limit+5) to 140
≤ 50: 1
> 50: 5
Sys Low 25 to (high limit-5)
Mean High Adult: (low limit+5) to 260
Pediatric: (low limit+5) to 215
Neonate: (low limit+5) to 125
Mean Low 15 to (high limit-5)
Dia High Adult: (low limit+5) to 250
Pediatric: (low limit+5) to 200
Neonate: (low limit+5) to 115
Dia Low 10 to (high limit-5)
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: 34 °C to 43 °C (93.2 °F to 109.4 °F)
Accuracy (Monitor mode) 25 °C to 32 °C (not including 32 °C): ±0.2 °C
32 °C to 44 °C (including 32 °C): ±0.1 °C
or
77 °F to 89.6 °F (not including 89.6 °F): ±0.4 °F
89.6 °F to 111.2 °F (including 89.6 °F): ±0.2 °F
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