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Welch Allyn VSM 6000 series - Regulatory Standards and Compliance

Welch Allyn VSM 6000 series
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NIBP specifications
Cuff pressure range Meets or exceeds ANSI/AAMI SP10:2002 standards for cuff pressure
range
Systolic range
Adult: 30 to 260 mmHg (StepBP, SureBP)
Pediatric: 30 to 260 mmHg (StepBP, SureBP)
Neonate: 20 to 120 mmHg (StepBP)
Diastolic range
Adult: 20 to 220 mmHg (StepBP, SureBP)
Pediatric: 20 to 220 mmHg (StepBP, SureBP)
Neonate: 10 to 110 mmHg (StepBP)
Cuff Inflation Target
Adult:160 mmHg (StepBP)
Pediatric: 120 mmHg (StepBP)
Neonate: 90 mmHg (StepBP)
Maximum Target Pressure
Adult: 280 mmHg (StepBP, SureBP)
Pediatric: 280 mmHg (StepBP, SureBP)
Neonate: 130 mmHg (StepBP)
Blood pressure determination time
Typical: 15 seconds
Maximum: 150 seconds
Blood pressure accuracy Meets or exceeds ANSI.AAMI SP10:2002 standards for noninvasive
blood pressure accuracy (±5 mmHg mean error, 8 mmHg standard
deviation)
Mean Arterial Pressure (MAP) range
The formula used to calculate MAP
yields an approximate value.
Adult: 23 to 230 mmHg (StepBP, SureBP)
Pediatric: 23 to 230 mmHg (StepBP, SureBP)
Neonate: 13 to 110 mmHg (StepBP)
Pulse rate range (using blood pressure
determination)
Adult: 30 to 200 bpm (StepBP, SureBP)
Pediatric: 30 to 200 bpm (StepBP, SureBP)
Neonate: 35 to 220 bpm (StepBP)
Pulse rate accuracy (using blood
pressure determination)
±5.0% (±3 bpm)
Overpressure cutoff
Adult: 300 mmHg ±15 mmHg
Pediatric: 300 mmHg ±15 mmHg
Neonate: 150 mmHg maximum
SureTemp Plus temperature module specifications
Temperature range 80°F to 110°F (26.7°C to 43.3°C)
Calibration accuracy
Average error ±0.3°F for oral, axillary, and rectal predictive measurements
Directions for use Specifications 95

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