Device Performance - Bosch vivatmo pro Instructions For Use Manual

9.2

Device Performance

Linearity
Four Vivatmo pro devices were tested as part of the linearity study. Nitric oxide (NO) was mixed in a balance gas of air to obtain
NO concentration levels between 8 to 300 ppb. The data showed that the test is linear across this range. The results are listed in
the table below.
Device
E8E8B712E469
E8E8B714CC4D
E8E8B710F568
E8E8B711FDEE
Analytical Precision
A nested components-of-variance design with 20 testing days, two runs per day and two replicate measurements per run for
each concentration was used. Evaluations were done according to CLSI guideline EP05. Repeatability describes the variation
within one run. Precision describes the variation between runs and days.
Device
124480
124710
136720
R^2
0.999
0.995
0.996
0.995
Repeatibility
25 ppb 50 ppb
1.47 1.88
1.22 1.77
1.42 1.83
Instructions for use
Slope
1.04
1.01
1.01
1.00
Within-device Precision
200 ppb 25 ppb
3.21% 1.98
3.33% 1.83
3.16% 1.87
© Bosch Healthcare Solutions GmbH
Technical data
Intercept
-1.88 ppb
0.63 ppb
0.62 ppb
1.53 ppb
50 ppb 200 ppb
2.48 5.66%
2.67 6.50%
2.70 6.43%
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