Clinical Study of Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard (BPM)
|ClinicalTrials.gov Identifier: NCT01295528|
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : February 14, 2011
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.
|Condition or disease||Intervention/treatment|
|Hypertension||Device: Comparison test|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||95 participants|
|Official Title:||Verify the functionS of BPM TMB-986 to Comply With ANSI/AAMI SP10|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||October 2010|
|Blood Pressure, Heart Rate, Monitor||
Device: Comparison test
Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.
- Verify the accuracy of measure functions of device [ Time Frame: 10 days ]Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic & Diastolic blood pressure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295528
|Wuhou District Hospital|
|Chengdu, Sichuan, China, 610041|
|Principal Investigator:||Guoqing Li, Director||Wuhou District Hospital|