Mediana P10 Manual de Serviço descarregar pdf (Página 106)

100

● Oscillometric Response

(Pressure Pulses)

● Cuff Pressure

Systole

MAP

Distole

MAP

Distole

MAP

Systole

TIME

Overall Accuracy Discussion

Overall system accuracy shall be determined by considering various influences of the

pressure sensor accuracy, motion artifacts, other artifacts created by the pressure valve,

technical errors of electrical components, and the origin error of oscillometric method.

The origin error of oscillometric comes from the basic theory that the MAP is determined

by the pulse. Therefore, there might be an error in determining the time between two

pulses. In other words, the greatest amplitude point of detected pulses can not represent

the MAP point exactly.

On the clinical trial perspective, overall system accuracy is not easy to determine. 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 Sphygmomanometers using the oscillometric method.

But, there are no absolute test protocols to determine the overall system accuracy of

Automated Sphygmomanometers using the oscillometric method. Normally, the Gold

standards of Blood pressure for reference are the intra-arterial pressure and the

auscultatory method.

The popular standard for overall system accuracy is AAMI SP-10:2002+A1:2003

(Electronic or automated sphygmomanometers).

The main test conditions are as follows:

A. Comparing Intra-arterial or auscultatory data by clinical experts with the automated

sphygmomanometer.

B. For data collection and 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)

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Mediana P10 Manual de Serviço Página 106