Verify the functionS of BPM TMB-986 to Comply With ANSI/AAMI SP10
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Verify the accuracy of measure functions of device
研究概览
简要总结
The clinical protocol of the clinical testing of this device:
- Objective of the test: To verify the function of device.
- Test methods and procedures: Performance test in two positions: Seated and Supine.
- DUT: Transtek Blood Pressure Monitor, Model: TMB-986. Cuff size: 22-32cm and 22-42cm.
- Comparison device: Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.
- Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.
- Statistical methodology used: Description of statistical methods.
- Result: Meet the requirements of SP10.
详细描述
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
- Test Purpose:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male,female,
排除标准
- •below 18 years old
结局指标
主要结局
Verify the accuracy of measure functions of device
时间窗: 10 days
Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic \& Diastolic blood pressure.
次要结局
未报告次要终点