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IX - A good means of controling high blood pressure : The self-measurement of blood pressure

10.1 - Why using a self-measurement device?
10.2 - The self-measurement device
10.3 - The Inflation and deflating of the cuff
10.4 - Ideal anatomical site for the measurement of the blood pressure
10.5 - Validation of the device
10.6 - Conditions and number of measurements

10.5 - Validation of the device

In order to guarantee a good quality of the measurement, the self-measurement device must be validated by independent organizations or experts in blood pressure measurement.

For the moment, there is no regulation control concerning this type of device in Europe. Thus, the quality of the self-measurement devices is very unequal, and only very few are currently validated.

10.5.1- Methods of validation

Presently, there are two methods of validation of the self-measurement device. The British Medical Society for high blood pressure is one and the other is the association for the development of the medical device (American association).

The principle of validation is based on the comparison between the level of the blood pressure obtained with the reference method, which is the mercury sphygmomanometer, and the device being validated.

The measurement is done at same time, using a branch in Y, a pipe being directed towards the reference device and the other one being directed towards the device being validated. For the "Advancement of medical instrumentation association", the difference between the two devices has to be under 5 mm of mercury (mean of the values).

The British Hypertension Society has a different way to validate the self measurement device: The device is classified with levels A to D, from best to worth device.

Absolute difference between devices (mmHg)
< or equal to 5
< or equal to 10
< or equal to 15
60 %
85 %
95 %
50 %
75 %
90 %
40 %
65 %
85 %
< C

To obtain a level, 3 percentages has to be upper or equal to values seen in each square. For example, to obtain a A level a minimum of 60% of the difference of 5 mmHg between the gold-standard device and the self-measurement device has to be detected, 85% of the difference for 10 mmHg between the two devices and 95% of the difference of 15 mmHg.

10.5.2 - The cuff

The validation of the device also includes the validation of the cuff, whose diameter must be well adapted to the circumference of the arm. A too small cuff tends to raise the blood pressure whereas a too large cuff has the opposite effect. There are three sizes of cuff: a child size, an adult size and an obese size.

10.5.3 - Reliability of the device with time

Surprisingly, there is not precise data relating to the lifespan and the reliability of the self-measurement devices with time. The maintenance provided by traders is often based on theoretical information.

In fact, we advise you to show your device regularly to your practitioner who will take simultaneously the blood pressure with his device and yours. According to the difference between the two techniques, your physician is able to validate your device.

10.5.4 - The validated self-measurement device of blood pressure

The validated blood pressure self-measurement devices are described in the following sheet (validation of the European Society of Hypertension):

Omron HEM-705CP
Omron HEM-703CP
Omron M4
Omron MX2
Omron HEM-722CP
Omron HEM-735CP
Omron HEM-713CP
Omron HEM-737 intellisense

The NISSEI DS-175 and PHILIPS HP-5332 devices are also partially validated by the British Society of Hypertension (respective levels : D/A and C/A).

All these devices are measuring blood pressure on the brachial site, and two wrist devices could be recommended : The Omron R3 and RX.

File last modified on : 28 sep 2003
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