Clinical Study of Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard

BTS International95 enrolled

Overview

The clinical protocol of the clinical testing of this device: 1. Objective of the test: To verify the function of device. 2. Test methods and procedures: Performance test in two positions: Seated and Supine. 3. DUT: Transtek Blood Pressure Monitor, Model: TMB-986. Cuff size: 22-32cm and 22-42cm. 4. Comparison device: Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg. 5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard. 6. Statistical methodology used: Description of statistical methods. 7. Result: Meet the requirements of SP10.

Hospital Information The data was collected by West China Medical College Clinical Investigator Team at Wuhou District Hospital, No. 9 Tongzilin Road, Wuhou District, Chengdu 610041, P.R. China. Investigator: Catharine Zhang, Nurse A; Vivian Luo, Nurse B; Dr. James Zhu, Sponsor. Contact Dr. James Zhu Tel: +8613308036568 Used Equipments DUT (Device Under Test): Transtek Blood Pressure Monitor, TMB-986 Reference Device: Yuyue medical BP meter, BP212, accuracy: ±1mmHg and range: 0-300mmHg. Test Protocol 1. Test Purpose: The aim of clinical test is to determine, for the purpose of design qualification, the overall performance of the system meeting the following requirement: For systolic and diastolic pressures, treated separately, the mean difference of the paired measurement of the test system and the comparison system shall be ± 5mmHg or less, with standard deviation of 8mmHg or less. 2. Target Subject: 1\) The subject database shall contain at least 85 subjects. 2) The distribution of blood pressure of the subjects required to be: At least 10 percent below 100mmHg systolic; at least 10 percent above 160mmHg systolic; at least 10 percent below 60mmHg diastolic; at least 10 percent above 100mmHg diastolic; with the remainder distributed between these outer limits. 3\. Identification and precision of equipment used According to ANSI/AAMI SP10, the maximum measurement error of the non-automatic sphygmomanometers used in the comparing test shall not exceed 1.0mmHg at the temperature of the test. The manometer was used to verify its accuracy before test. The clinical study was conducted according to the protocol described in the ANSI/AAMI SP10 with 95 subjects. 4\. Test procedures (auscultatory method, same-limb sequential measurement was chosen) 1. Record the age, gender, and circumference of the left arm of the subject. 2. Let subject seated or supine calmly for two minutes before test. 3. Measure heart rate in one minute by palpation on radial artery, record it. Fig. 0 Method of auscultatory validation 4) As shown in Fig. 0, two observers shall make simultaneous, blinded, blood pressure determination on the subject's left arm. Each nurse will write down the reading on a small piece of paper, make a tick if there is an auscultatory gap and then submit to the recorder. 5\) The two readings separately from two observers will be recorded, and if two observers agree that they find an auscultatory gap this time, it will also be recorded. The arm cuff will be take off, after 90 seconds rest, TMB-986 cuff will be taken on and tested, and the readings (systolic, diastolic, mean BP and Heart rate) be recorded. 6\) For each subject, repeat 3) and 5) to get 3 measurements. 7) Repeat step 1) to 6) for every subject. 5. Note: 1. No motion and speaking are allowed during the measurement. 2. DUT uses the 22-42cm Cuff when the arm circumference of patients above 32cm and the other patients use 22-32cm Cuff. 3. The reference device's cuff release at the rate about 3 mmHg/s so to ensure an accurate reading of observer. 4. The arm of the same height and heart when measurement. 5. Test environment: Temperature: 20±1℃; Relative humidity: 40\~50%.