Introduction
Year | 1998-2019 | 2020 | 2021-2022 | ≥2023 |
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Devices | Mercury sphygmomanometer | Greenlight (mercury-free AD) | 6-18 years: Greenlight ≥19 years: Microlife | Microlife (OD) |
Participants | ≥aged 10 years | ≥aged 6 years | ||
Place | Four mobile examination centers |
Part 1. BP measurement using Microlife Watch BP Office AFIB®
Participants
Device details
Device setting
Setting item | Set value |
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Action mode | ROUTINE mode |
Default pressurization setting | Automatic pressurization |
Default cuff side | Right arm cuff (R), Switch to left arm cuff (L) for left arm measurement |
HIDE mode setting | OFF mode |
Measurement numbers | Three consecutive measurements with 3- second intervals in between, but no more than five consecutive measurements |
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◽ Default setting [12, 16]
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Select an operation mode, «ROUTINE» Mode
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Select the right (R) cuff
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Device is defaulted to the left (L) arm cuff → Press and hold the M button for 3 seconds → Switch the left cuff to the right (R) cuff → Press the Start/Stop button to save the setting.
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Switch to the right (R) cuff whenever you turn on the power button.
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Connect the cuff to the device by inserting the cuff connector in the cuff connector socket (right socket for right arm cuff)
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Set on automated triple measurements with 30-second intervals
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The device automatically takes three consecutive measurements at default 15-second intervals → Pressing and holding the Start/Stop button for 3 seconds → Press the M Button to adjust the measurement intervals, and be set as 30-second intervals → Press the Start/Stop Button to confirm.
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Activates HIDE function, “OFF”
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The Microlife has defaulted features a “HIDE function, ON” to prevent unnecessary elevated BP in patients due to nervousness triggered by visible BP measurements. However, in the KNHANES, it was set as HIDE mode “OFF” feature to facilitate interpretation of BP values and detect errors during BP measurements → Press and hold the M Button for 7 seconds → Press the M Button again to turn the “HIDE OFF” function → Press Start/Stop button to confirm the setting.
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◽ Display the “Afib” icon to detect atrial fibrillation
Preparations before BP measurement
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◽ Wear a disposable gown for the examination
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◽ Sitting position
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◽ History taking
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◽ Arm selection
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◽ Pulse measurement
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◽ Arm position
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◽ Cuff selection
Cuff size of Microlife | Cuff width (cm) | Cuff length (cm) | Arm circumference (cm) | Actual arm circumference range (cm) |
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Child Small (XS)a | 11 | 35 | 14 - 22 | 14-21.9 |
Adult Medium (M)a | 15 | 53.5 | 22 - 32 | 22-31.9 |
Adult Large (L)a | 16.5 | 63.5 | 32 - 42 | 32-41.9 |
Adult Large/Extra Large (L/XL) | 16.5 | 70 | 32 - 52 | 42-52 |
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◽ Palpation of the upper arm (brachial) artery
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◽ Cuff wrapping
BP measurement process
Recordings
Part 2. BP measurement using Greenlight 300TM
Device details
Preparations before BP measurement
BP measurement process
Part 3. Quality control management: calibration process of each device
Proper environment for BP measurement
Examiner`s education
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◽ Quality control and assurance of the BP measurement program1.BP measurement training program to improve the auscultation technique was carried out in two phases.
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In the first phase, examiners pass the examination using a “Non-mercury Auscultation Training Video” produced by the QC team in 2022 consisting of 10 duplicated readings obtained values using a mercury-free Greenlight device. The test was conducted three times a year for the examiners. Validation criteria are as follows: BP differences of ≤5 mmHg in ≥90% of readings and of ≤10 mmHg in ≥95% of readings (level 1); BP differences of the sum of the absolute values of the systolic and diastolic BP of ≤10 mmHg (level 2); BP difference of ≤10 mmHg in ≥90% of readings for evaluating intra-examiner variability (level 3); Examiners must pass Level I to Level III.
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In the second phase, examiners pass “Hands-on Training with Expert”, which evaluate the mean difference in systolic and diastolic BP compared with the expert in three simultaneous readings using Greenlight. The validation criterion is that the BP difference did not exceed 2 mmHg.
2.Training on how to use a Microlife and Greenlight device.3.Video monitoring of each specific BP measurement procedure using Greenlight once a year. -
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◽ Evaluate video monitoring of the skills of examiners for the weekly calibration process by the QC team once a yearVideo monitoring of the skills of examiners for the weekly calibration process including a weekly pressure accuracy test and cuff leakage test was evaluated using an evaluation table by the QC team once a year.
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◽ On-site evaluation of BP measurement
Device calibration of Microlife
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◽ Five-step QC process of MicrolifeFive-step QC process of Microlife is summarized in Fig. 5.
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Step 1 is “before-use calibration” (= pressure accuracy test), performed once a year. This step evaluates the pressure accuracy of the test device against the reference device by the manufacturer’s technicians. RIGELBP-BP SIM NIBP simulator® (BP-SIM, Rigel Medical, USA) [30] was used for reference standard of device validation. The technician takes a picture of the pressure values to determine the accurate pressure difference between the test device and the reference device for each test scale. Four Microlifes and BP-SIM were connected in parallel and obtained 40 readings per device over a range of pressure on 280-60 mmHg scales (10 calls per deflation, 280, 240, 200, 180, 160, 140, 120, 100, 80, 60 mmHg) and calculated the pressure differences between the test device and the reference simulator or between the test devices with multiple comparisons [Supplementary Figure S4 (A)]. Pressure differences between the test device and the reference simulator were calculated by subtracting the test pressure from the reference pressure value for each data point. Then, inter-device pressure differences between Microlifes were calculated. As validation criteria, at least 38 of 40 (95%) pressure differences between the reference and the test measurement pairs and inter-device pressure differences must be within ± 3 mmHg of each other.
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Step 2 is “in-use calibration”, performed using the same methods as before-use calibration.
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Step 3 is “after-use calibration”, performed using the same methods as before-use calibration.
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Step 4 is “daily QC”, carried out by a trained nurse in each MEC with a daily checklist.
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Step 5 is “weekly QC”. An examiner in each MEC performed a pressure accuracy and cuff leakage test using the MEC simulator. Microlife is placed in the CHECK mode by pressing the START/STOP and I/O switch buttons simultaneously, and the MEC simulator sets ‘SEL 1’ for the pressure accuracy test. The test device (Microlife), air tank, and the MEC simulator is connected with a t-tube [(Supplementary Figure S5 (A)] and obtained 10 pressure readings per device over a range of pressure on 280-60 mmHg scales (10 calls per deflation, 280, 240, 200, 180, 160, 140, 120, 100, 80, 60 mmHg) and calculated the pressure differences. Pressure differences between the MEC simulator and the test devices were calculated by subtracting the test pressure from the reference pressure value for each data point. The validation criteria are that at least 9 of 10 (90%) pressure differences between the reference and the test measurement pairs must be within ± 3 mmHg of each other. The weekly pressure accuracy test is performed once per two weeks. For the cuff leakage test, the MEC simulator sets ‘SEL 2’. After wrapping the cuff tightly around the air tank, the test cuff of Microlife and MEC simulator were connected with a connecting tube [Supplementary Figure S6 (A)] and checked the air leakage at 300 mmHg for one minute and calculated the leakage pressure of the test cuff compared with the MEC simulator. The validation criterion is that leakage pressure must be within ± 6 mmHg in a minute
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Device calibration of Greenlight
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◽ 5-Step QC process of Greenlight
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Step 1 is “before-use calibration” (= pressure accuracy test), performed once a year. Two Greenlight and BP-SIM were connected in parallel [Supplementary Figure S4 (B)] and obtained 20 readings per device over a range of pressure on 280-60 mmHg scales and calculated the pressure differences between the test device and simulator. The validation criterion is that at least 19 of 20 (95%) pressure differences between the reference and test measurement pairs must be within ± 3 mmHg of each other.
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Step 2 is “in-use calibration”, performed the same methods as “before-use calibration”.
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Step 3 is “after-use calibration”, performed the same methods as “before-use calibration”.
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Step 4 is “daily QC”, carried out by an examiner in each MEC using a daily checklist.
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Step 5 is “weekly QC”, including pressure accuracy and cuff leakage test, carried out by an examiner in MEC using the MEC simulator. MEC simulator sets ‘SEL 1’ for the pressure accuracy test. Then, the test device (Greenlight), air tank, and MEC simulator is connected to t-tube [Supplementary Figure S5 (B)], and the pressure accuracy test is performed similarly to the weekly pressure accuracy test of Microlife. The validation criterion is that at least 9 of 10 (90%) reference and test measurement pairs must be within ± 3 mmHg of each other. The weekly cuff leakage test of the Ambidex® cuff of Greenlight against the MEC simulator is performed using the same methods as the weekly cuff leakage test of the Microlife cuff against the MEC simulator [Supplementary Figure S6 (B)]. The validation criterion is that leakage pressure must be within ± 6 mmHg in a minute.
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