The quality of measurement of Circa 120/80 blood pressure monitors are of the highest of standards.Clinical validation - what is it?
Blood pressure monitors must be clinically validated before being sold. Clinical validation verifies the measurement of accuracy and tests performed with selected subjects who meet certain criteria (blood pressure classification, age, sex, pre-existing diseases, etc.).
There are qualitative and quantitative differences between the various existing validation methods. Therefore, when choosing a blood pressure monitor, you should always ask to what extent it is “clinically validated”. Validation of a blood pressure monitor is a standard requirement, but what is more important is to know to what extent it has been validated.
Basic Validation :
Basic validation is performed on a group of subjects that is representative of an "average population without any diagnosed pre-existing conditions". The larger the number of subjects, the more it is statistically significant, thus more reliable the validation test is. For example, basic validations can be based on the test protocols of the following institutions:
*There are differences between the test protocols of these institutions; for example with regards to the group size.
Another difference in blood pressure ranges examined is that the blood pressure ranges in blood pressure monitors are tested for different measurements of accuracy depending on the protocol (see graph).The broader the range, the more the devices are considered reliable at extremely low or extremely high blood pressure.
Special patient validations
Because of the technique that is used in automated oscillometric blood pressure monitors, they can be inaccurate when used in so-called special patient groups. This can lead to the fact that a blood pressure monitor that is validated in “regular subjects” may not give accurate readings when used e.g. during pregnancy or when used in children, elderly or diabetes patients. This can have serious clinical consequences. Therefore, medical standard authorities require that a blood pressure monitor may only be recommended for such a special patient group if it has been validated for this specific group. Circa 120/80 blood pressure monitors have passed several of these challenging validations so that they can now be recommended for all of the following special patient groups.
Cuffs are as important as the blood pressure monitors itself.
Validations are generally performed with standard sized cuffs, however, Circa 120/80 has put extra attention to validations with all type of cuffs (soft cuffs, rigid cuffs, wide-range cuffs, etc.). In order to ensure accurate blood pressure values of patients, Circa 120/80 has also developed an XL-cuff for large arm-circumference patience's, and being the only provider of a validated XL-cuff for home BP monitors, we highly recommended them for overweight patients.
Conical cuff 22-42cm.
Suitable for all common arm sizes.
Add Also available in small / XL sizes.
Recommended by NICE (UK)
The National Institute for Health and Care Excellence (NICE) officially recommends using the Circa during routine blood pressure measurement for all GP’s in the United Kingdom. www.nice.org.uk/MTG13
Validated According to Protocols of
Embedded Guidelines of