Validations

Eris_Circa_AFIB_Sense

AFIB Sense

AFIB monitors which allow Atrial Fibrillation screening during blood pressure measurement with proven accuracy.

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Circa_120by80_Pre_Eclampsia

For Pre-Eclampsia/Pregnancy

Circa 120/80 allows pregnant women to measure their blood pressure at home in pre-eclampsia.

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Accurate_measurements_for_12to18years_children

For children above 12 years

Accurate measurements for children between 12-18 years.

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Circa_bp_monitors_for_Diabetic_Patients

For Diabetic Patients

Validated blood pressure monitors for patients with Diabetes Mellitus type 1 and 2.

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Clinically validated

The quality of measurement of Microlife 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:

all-logos

*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.

chart for 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. Microlife 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.

Special patient validations

All Microlife's special patient validations at a glance:

All Microlife's special patient validations at a glance

Cuff validations:

Cuffs are as important as the blood pressure monitors itself.

Validations are generally performed with standard sized cuffs, however, Microlife 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, Microlife 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.

Recommendation:

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

Validation:

Validated According to Protocols of

  • Circa ISO_certified_logo
  • AAMI_healthcare

Embedded Guidelines of

  • American_heart_association
  • BIHS_logo
  • ESH_logo