Philips EarlyVue VS30 - Page 255

EarlyVue VS30 Instructions for Use 16-13
SpO
2
Specifications
In addition to calculating the A
rms
values over the range from 70% to 100% SaO
2
as
required by the international standards for pulse oximeters ISO 9919,
1,2
the desaturation
study data was evaluated according to the method Agreement Between Methods of
Measurement with Multiple Observations Per Individual described by Bland and Altman.
3
The graphical plots show all of the data points for the sensor and device combinations
according to the Bland and Altman method.
The tables show the A
rms
values measured in the study using the specified sensor with
the pulse oximetry board that is used in the VS30 monitor.
M1191B
The Philips sensor M1191B was tested as representative of the Philips sensor M1191BL.
1.
ISO 9919:2005: Medical electrical equipment - Particular requirements for the basic safety and essential per-
formance of pulse oximeter equipment for medical use.
2.
ISO 80601-2-61:2011: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment.
3.
Bland, J. Martin and Altman, Douglas G., (2007) Agreement Between Methods of Measurement with Multiple
Observations Per Individual, Journal of Biopharmaceutical Statistics, 17:4, 571-582
SaO
2
range (%) 70-100 70-80 80-90 90-100
A
rms
value (%) 1.25 1.24 1.14 1.32
SpO
2
- SaO
2
(%SpO
2
)
Upper 95% Limit = +2.43
Mean Difference = -0.05
Lower 95% Limit = -2.52
BGA Reference (%SaO
2
)
N = 331, between-subject variance = 0.463, within-subject variance = 1.131