System Processing Description
ARGUS VCM
On clinical trial perspective, overall system accuracy is not easy to be determined. The
clinical trial test protocols have been tried and have been described in many treatises,
and international standards. So, there are many methods to determine the overall
system accuracy of Automated Sphygmomanometer using the oscillometric method.
But, there are no absolute test protocols to determine the overall system accuracy of the
Automated Sphygmomanometer using oscillometric method. Normally, the Gold
standards of Blood pressure for the reference are the intra-arterial pressure and the
auscultatory method.
The popular standard for the overall system accuracy is AAMI, SP-10 1992; 1996
(Electronic or automated sphygmomanometers).
The main test conditions are as follow:
A. Data comparing the Intra-arterial or the auscultatory by the clinical experts with
the automated sphygmomanometer.
B. For data collection and the data analysis, Bland-Altman Plot is used.
C. On the systolic, diastolic, and MAP, the Deltas of all measurements shall be met
under +/- 5mmHg of mean difference (MD), and +/- 8mmHg of standard deviation
(SD).
(Delta = Intra-arterial or Auscultatory – Automated sphygmomanometer)
20
-20
-15
-10
-5
0
5
10
15
200
180
160
140
120
100
SYSTOLIC PRESSURE
Mean difference(MD): 0 mmHg
Standard deviation(SD): 6 mmHg
mean + 2 SD
mean
mean - 2 SD
Average of test and reference methods (mmHg)
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ee
n t
es
t a
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r
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er
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nc
e m
e
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(
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(EXAMPLE) Agreement between test and reference methods for systolic pressure. Hypothetical data
ARGUS VCM
Service Manual 67
