Welch Allyn 300 Series Vital Signs Monitor - User Manual User Manual

Page 76

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72

Chapter 7 Reference

Welch Allyn Vital Signs Monitor 300 Series

Characteristic

Specification

Notes

Temperature

Temperature
Measurement Range

80

F to 110 F

26.7

C to 43.3 C

Temperature Calibration
Accuracy

± 0.2

F (± 0.1 C); meets or exceeds ASTME1112-00; EN12470-3:2000

Temperature
Determination Time

predictive
(typical)

oral
axillary
rectal

4 seconds
10 seconds
15 seconds

SpO

2

Characteristic

Specification

Notes
All sensors have a measurement range of
70% - 100%. SpO2 complies with EN ISO
9919:2005.

Saturation (% SpO

2

)

Range
Resolution

1% to 100%, but limited by sensors and by sensor manufacturers’ technology
1%

Alarm limits

50% to 98% (lower)
52% to 100% (upper)

Probe accuracy (adult,
pediatric, neonate)

Accuracy for saturation levels below 70% is unspecified.

Pulse rate alarm limits

25 to 298 beats/min (lower)
27 to 300 beats/min (upper)

Pulse rate accuracy

± 3 beats/min typical; varies with sensor model

Display update interval
at the monitor

1 second

Alarm hold

-

off period

10 seconds; resets if the sensor reports levels within limits before 10 seconds elapses.

Circuitry

Microprocessor controlled
Automatic self

-

test of oximeter when powered on

Automatic setting of default parameters
Automatic alarm messages

Electrosurgery
interference suppression

Yes

Sensor compatibility

For a complete list of compatible sensors refer to

www.welchallyn.com

.

Nellcor

For probe/sensor compliance to EN ISO 9919:2005, see the Nellcor directions for use.

Sensor lights (Nellcor)

Red wavelength
Infrared wavelength

660 nm (nominal), 31.3 mW (max)
920 nm (nominal), 28.8 mW (max)

Risk mitigation: Software in this device is developed under the FDA guidance of Part 802.3 design controls and the
international standard EN 14971 risk management. These mitigate and minimize any risk associated with potential
software errors to a level as low as reasonably possible (ALARP).

Note

SpO

2

specifications are published by the SpO

2

component manufacturer and

tested by Welch Allyn using the BIO-TEK Index 2 SpO

2

simulator.

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