SPECTRO2 30 WW1030 Addendum Sensory Summary Based on Desat 38 Rev 0 Sept 2009

Addendum to WW1924 Operation Manual BCI® WW1030 Pulse Oximeter Sensor Summary1 Clinical Investigation Results (Based on Desat 38)

Data Sets Standard Deviation (%-SpO2)

ARMS (%-SpO2)

Minimum Difference (%-SpO2)

Maximum Difference (%-SpO2)

Unavailable

Excluded

®

BCI 3444

Average Difference (%-SpO2)

Analyzed

Sensor (Oximeter)

Accuracy (%-SpO2)

0.26

1.93

1.94

-3

8

442

0

0

±2

BCI 1300

®

2

0.34

1.49

1.53

-3

7

420

22

0

±2

BCI 1302

®

3

-0.32

1.99

2.01

-5

8

442

0

0

±2

®

4

1.07

2.22

2.46

-3

11

442

0

0

±2.5

BCI 3078

2.26

2.45

3.33

-3

9

221

0

0

±4

BCI 3026 ®

1

This clinical investigation included ten healthy, non-smoking adult subjects (five female) who ranged in ages from 20 to 39 years (mean 25.9 years). The subjects’ described their ethnicity as Not Hispanic or Not Latino (8) and Hispanic or Latino (2). There were two Black or African American and seven White subjects in this clinical investigation. One subject did not state their race. 2 BCI® 1300 and BCI® 1301 sensors vary only in attachment tape design and distance between the emitter and detector. 3 BCI® 1302 and BCI® 1303 sensors vary only in attachment tape design and distance between the emitter and detector. 4 BCI® 3025 and BCI® 3026 sensors vary only in housing length and distance between the emitter and detector. 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-ADD2 Rev 0

J 2009-09

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