SPECTRO2 30 WW1030 Addendum Sensory Summary Based on Desat 37 Rev 0 Sept 2009

Addendum to WW1924 Operation Manual BCI® WW1030 Pulse Oximeter Sensor Summary1 Clinical Investigation Results (Based on Desat 37)

Data Sets Average Difference (%-SpO2)

Standard Deviation (%-SpO2)

ARMS (%-SpO2)

Minimum Difference (%-SpO2)

Maximum Difference (%-SpO2)

Analyzed

Unavailable

Excluded

Accuracy (%-SpO2)

BCI 3044

®

-0.91

1.64

1.87

-7

6

440

0

0

±2

BCI 3078

®

2.22

3.03

3.75

-4

12

220

0

0

±4

BCI 3043

®

1.43

2.23

2.65

-3

7

220

0

0

±3

®

0.02

1.52

1.51

-8

7

220

0

0

±2

Sensor (Oximeter)

BCI 3178

1

This clinical investigation included ten healthy, non-smoking adult subjects (six female) who ranged in ages from 20 to 30 years (mean 24.6 years). The subjects’ described their ethnicity as Not Hispanic or Not Latino (10). There were two Black or African American and eight White subjects in this clinical investigation. BCI and the Smiths design mark are trademarks of the Smiths Medical family of companies. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. © 2009 Smiths Medical family of companies. All rights reserved.

WW1924-ADD1 Rev 0

J 2009-09

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