Clinical Study of Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard (BPM)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|