VS 8/VS 8A Vital Signs Monitor Operator’s Manual A - 13
* Measurement accuracy verification: In adult and pediatric modes, the blood pressure
measurements measured with this device are in compliance with the American National
Accuracy Max average error: ±5 mmHg
Max standard deviation: 8 mmHg
Static pressure
measurement range
0 mmHg to 300 mmHg
Static pressure
measurement
accuracy
±3 mmHg
Resolution 1 mmHg
Initial cuff inflation
pressure range
(mmHg) (for
Deflation algorithm)
Adult:
Pediatric:
Neonate:
80 to 280
80 to 210
60 to 140
Default initial cuff
inflation pressure
(mmHg) (for
Deflation algorithm)
Adult:
Pediatric:
Neonate:
160
140
90
Software
overpressure
protection
Adult:
Pediatric:
Neonate:
297±3 mmHg
297±3 mmHg
147±3 mmHg
Hardware
overpressure
protection
Adult:
Pediatric:
Neonate:
≤330 mmHg
≤330 mmHg
≤165 mmHg
Alarm limit Range (mmHg) Step (mmHg)
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)
A - 14 VS 8/VS 8A Vital Signs Monitor Operator’s Manual
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
SmarTemp™ Temperature Module
Statistical Results of Clinical Investigation Data
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)
Temperature display range 25 °C to 44 °C (77 °F to 111.2 °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 0.1 °F
Minimum measurement
time for accurate readings
Monitor mode: <60 s
Predictive mode: <20 s (typical test: < 12 s)
Sensor type NTC
Alarm limit Range Step
Temp High (low limit +1) °C to 44 °C 0.1 °C
Temp Low 25 °C to (high limit -1) °C
Clinical BIAS (Δcb)
Limits of Agreement (LA)
Clinical
Repeatability (σr)
Oral 0.02°C 0.33°C 0.1°C
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