Validation of the QMon-20 oscillometric blood pressure monitor for professional office use in the general population according to the ANSI/ESH/ISO 81060–2

BACKGROUND High blood pressure is one of the most common reasons why patients seek assistance in daily clinical practice. Screening for hypertension is fundamental and, because hypertension is identified only when blood pressure is measured, accurate measurements are key to the diagnosis and management of this disease. The European Society of Hypertension International Protocol revision 2010 (ESH-IP2) was developed to assess the validity of automatic blood pressure measuring devices that are increasingly being used to replace mercury sphygmomanometers. OBJECTIVE We sought to determine whether the iHealth Track blood pressure monitor meets ESH-IP2 requirements for self-measurement of blood pressure and heart rate at the brachial level and is appropriate for use in the general population. METHODS This study was a descriptive investigation. ESH-IP2 requires a total number of 33 participants. For each measure, the difference between observer and device blood pressure and heart rate values is calculated. In all, 99 pairs of blood pressure differences are classified into 3 categories (≤5, ≤10, and ≤15 mm Hg), and 99 pairs of heart rate differences are classified into 3 categories (≤3, ≤5, and ≤8 beats/min). We followed these protocol procedures in a convenience sample of 33 participants. RESULTS iHealth Track fulfilled ESH-IP2 requirements and passed the validation process successfully. We observed an absolute difference within 5 mm Hg in 75 of 99 comparisons for systolic blood pressure, 78 of 99 comparisons for diastolic blood pressure, and 89 of 99 comparisons for heart rate. The mean differences between the test and standard readings were 4.19 (SD 4.48) mm Hg for systolic blood pressure, 3.74 (SD 4.55) mm Hg for diastolic blood pressure, and 1.95 (SD 3.27) beats/min for heart rate. With regard to part 2 of ESH-IP2, we observed a minimum of 2 of 3 measurements within a 5-mm Hg difference in 29 of 33 participants for systolic blood pressure and 26 of 33 for diastolic blood pressure, and a minimum of 2 of 3 measurements within a 3-beat/min difference in 30 of 33 participants for heart rate. CONCLUSIONS iHealth Track readings differed from the standard by less than 5, 10, and 15 mm Hg, fulfilling ESH-IP2 requirements. Consequently, this device is suitable for use in the general population.

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Validation in the General Population of the iHealth Track Blood Pressure Monitor for Self-Measurement According to the European Society of Hypertension International Protocol Revision 2010: Descriptive Investigation

JMIR mhealth and uhealth ◽

10.2196/13137 ◽

2019 ◽

Vol 7 (3) ◽

pp. e13137

Author(s):

Victoria Mazoteras-Pardo ◽

Ricardo Becerro-De-Bengoa-Vallejo ◽

Marta Elena Losa-Iglesias ◽

Daniel López-López ◽

Patricia Palomo-López ◽

...

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

General Population ◽

Systolic Blood Pressure ◽

Diastolic Blood Pressure ◽

European Society ◽

Absolute Difference ◽

Blood Pressure Monitor ◽

Pressure Monitor ◽

Convenience Sample

Background High blood pressure is one of the most common reasons why patients seek assistance in daily clinical practice. Screening for hypertension is fundamental and, because hypertension is identified only when blood pressure is measured, accurate measurements are key to the diagnosis and management of this disease. The European Society of Hypertension International Protocol revision 2010 (ESH-IP2) was developed to assess the validity of automatic blood pressure measuring devices that are increasingly being used to replace mercury sphygmomanometers. Objective We sought to determine whether the iHealth Track blood pressure monitor meets ESH-IP2 requirements for self-measurement of blood pressure and heart rate at the brachial level and is appropriate for use in the general population. Methods This study was a descriptive investigation. ESH-IP2 requires a total number of 33 participants. For each measure, the difference between observer and device blood pressure and heart rate values is calculated. In all, 99 pairs of blood pressure differences are classified into 3 categories (≤5, ≤10, and ≤15 mm Hg), and 99 pairs of heart rate differences are classified into 3 categories (≤3, ≤5, and ≤8 beats/min). We followed these protocol procedures in a convenience sample of 33 participants. Results iHealth Track fulfilled ESH-IP2 requirements and passed the validation process successfully. We observed an absolute difference within 5 mm Hg in 75 of 99 comparisons for systolic blood pressure, 78 of 99 comparisons for diastolic blood pressure, and 89 of 99 comparisons for heart rate. The mean differences between the test and standard readings were 4.19 (SD 4.48) mm Hg for systolic blood pressure, 3.74 (SD 4.55) mm Hg for diastolic blood pressure, and 1.95 (SD 3.27) beats/min for heart rate. With regard to part 2 of ESH-IP2, we observed a minimum of 2 of 3 measurements within a 5-mm Hg difference in 29 of 33 participants for systolic blood pressure and 26 of 33 for diastolic blood pressure, and a minimum of 2 of 3 measurements within a 3-beat/min difference in 30 of 33 participants for heart rate. Conclusions iHealth Track readings differed from the standard by less than 5, 10, and 15 mm Hg, fulfilling ESH-IP2 requirements. Consequently, this device is suitable for use in the general population.

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Study on Cuff-Less Blood Pressure Measurement Based on Electrocardiography and Photoplethysmography Signal

ICONIET PROCEEDING ◽

10.33555/iconiet.v2i3.34 ◽

2019 ◽

Vol 2 (3) ◽

pp. 206-214

Author(s):

Putri Indes Oktabriani ◽

Fuad Ughi ◽

Aulia Arif Iskandar

Keyword(s):

Blood Pressure ◽

Pressure Measurement ◽

Blood Pressure Monitoring ◽

Blood Pressure Measurement ◽

Ecg Signal ◽

Optimum Location ◽

Blood Pressure Monitor ◽

Pressure Monitor ◽

Left Hand ◽

Measure Blood Pressure

The continuous blood pressure measurement research is widely known for helpingthe development of ambulatory blood pressure monitoring where it measures blood pressureevery 15 to 30 minutes throughout the day. The cuff is a problem for the patient withAmbulatory Blood Pressure Monitor. It can make a person feel uncomfortable and must staystill when the cuff starts to inflate. It is limiting and disturbing their daily activity when thedevice is starting to measure the blood pressure. Blood pressure measurement without cuff isbeing proposed in this research, called cuff-less blood pressure measurement. It will be based onPhotoplethysmography (PPG) and Electrocardiography (ECG) signal analysis. ECG (Lead 1,Lead 2, and Lead 3) with PPG signal produced from index finger on the left hand are comparedand analyzed. Then the relation of PPG and ECG signal and the optimum location for daily usecan be obtained. The optimum location will be based on the electrode’s position that producedthe optimum ECG lead Signal to measure blood pressure. Based on the result, PPG and ECGsignal have a linear relation with Blood Pressure Measurement and Lead 1 is more stable inproducing the ECG signal. The equation from Lead 1 appeared as one of the optimum equationsfor measuring Systolic Blood Pressure (SBP) or Diastolic Blood Pressure (DBP).

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