SPECTRO2 30 WW1030 Addendum Sensory Summary Based on Desat 39 Rev 0 Sept 2009

Addendum to WW1924 Operation Manual ®

BCI WW1030 Pulse Oximeter Sensor Summary1 Clinical Investigation Results (Based on Desat 39) Data Sets Standard Deviation (%-SpO2)

ARMS (%-SpO2)

Minimum Difference (%-SpO2)

Maximum Difference (%-SpO2)

Unavailable

Excluded

(Sensor)

Average Difference (%-SpO2)

Analyzed

Oximeter or Module

Accuracy (ARMS) (%-SpO2)

0.04

2.18

2.18

-25

10

856

24

0

±3

-0.36

2.02

2.05

-13

6

414

26

0

±2.5

0.36

1.90

1.93

-4

8

414

26

0

NA

Condition ®

BCI 1300 Motion – Test

Nellcor DS-100A Sensor Test

®

BCI 1300 Non-motion – Control

1

This clinical investigation included ten healthy, non-smoking adult subjects (four female) who ranged in ages from 22 to 34 years (mean 27.3 years). The subjects’ described their ethnicity as Not Hispanic or Not Latino (7) and Hispanic or Latino (3). There were two Black or African American and seven White subjects in this clinical investigation. One subject did not indicate a race. Note 1: The Nellcor DS-100A sensor was previously tested in desaturation study Desat 37. Subsequent hardware and software changes were made to improve performance while using Nellcor sensors (see Additional Document Section of Desat 39 Binder). Note 2: 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-ADD3 Rev 0

J 2009-09

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