User Manual

Directions for Use Chapter 7 Reference 67
Physical
Characteristic Specification Notes
Temperature
Temperature Measurement
Range
80 Fto110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.
Pulse Rate Range 25 to 240 bpm
Pulse Rate Accuracy ± 3 bpm
± 5 bpm
No motion
Motion
± 3 digits Low perfusion
SpO
2
Accuracy 70-100% ± 2 digits Adult and pediatric
70-100% ± 3 digits Neonate
Pulse Oximetry (SpO
2
)
Saturation Range
1% to 100%
Electrosurgery interference
suppression
Yes
Sensor compatibility For a complete list of compatible sensors refer to www.welchallyn.com.
Masimo For probe/sensor compliance to EN ISO 9919:2005, see the Masimo directions for use.
Sensor lights (Masimo)
Red wavelength
Red wavelength (toe clip)
Infrared wavelength
Infrared wavelength (toe
clip)
 15 mW at 50 mA pulsed
660 nm
663 nm
905 nm
880 nm
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.
Characteristic Specification
Dimensions
height 6.6 inches 16.8 cm
width 10.0 inches 25.4 cm
depth 6.0 inches 15.2 cm
Weight Approximately 5.4 lbs (2.4 kg)
Color, Temperature Probe
Oral/Axillary Blue
Rectal Red