Verify Wrist BPM TMB-1117 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
- 85
- 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 efficiency of device.
- Test methods and procedures: Clinical test in two positions: Seated and Supine.
- DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.
- Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
- 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
Hospital Information The data was collected by Zhongshan City People's Hospital Clinical Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan, Guangdong 528403, P. R. China.
Investigator: Dr. Cao Yuedong, Leader; Li Qidong, Nurse A; Chen Wenqian, Nurse B.
Contact Dr. Cao Yuedong Tel: +86 760 88823818
Used Equipments DUT (Device Under Test): Transtek Wrist Blood Pressure Monitor, TMB-1117 Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
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
研究者
Leo Wang
Team leader
BTS International