Appendix d: specifications, Patient population – Welch Allyn Vital Signs Monitor - User Manual User Manual

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Vital Signs Monitor

APPENDIX D: Specifications

Performance Specifications

The performance specifications of the Welch Allyn Vital Signs Monitor are as follows:

Patient Population

The Welch Allyn Vital Signs Monitor is designed for use with adult and pediatric patients. The moni-
tor is not intended for use with neonates. Welch Allyn defines neonates as children 28 days or less
of age if born at term (37 weeks gestation or more); otherwise, up to 44 gestational weeks. This
definition comes from the AAMI SP10 1992 standard.

Cuff Pressure Range

0 - 300 mmHg

Initial Cuff Inflation

Default cuff inflation pressure is 160 mmHg. Operator may change this default in configuration
mode. Options are 120, 140, 160, 180, 200, 240 and 280 mmHg.

Systolic Range
60 - 250 mmHg

Diastolic Range
30 - 160 mmHg

Blood Pressure Accuracy

Blood pressure accuracy meets or exceeds SP10-1992 AAMI standards for non-invasive blood pres-
sure accuracy (AAMI standard: ± 5 mmHg mean error; 8 mmHg standard deviation). Blood pres-
sure accuracy is validated for pressure measurement using the upper arm only, with the patient in a
seated position. Blood pressure is validated against manual auscultatory readings for adults and chil-
dren above the age of 3. For children under age 3 blood pressure is validated against intraarterial
readings. The monitor is not validated for use with neonates.

Blood Pressure Determination Time
20 seconds to 45 seconds typical, 165 seconds maximum.

Pulse Rate Range
40 - 200 bpm

Pulse Rate Accuracy (using Blood Pressure Determination)
± 5.0%

Pulse Rate Accuracy (using SpO

2

Determination)

Without Motion: ± 3 digits***
With Motion: normal physiologic range (55 - 125 bpm) ± 5 digits
Low Perfusion: ± 3 digits***

*** Specification applies to monitor performance and was validated with Biotek and Nellcor simulators.

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