Clinical Study of Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 (BPM_S)
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: LS-802. Cuff size: 22-32 cm and 22-42 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Verify the Functions of BPM LS-802 to Comply With ANSI/AAMI SP10|
- Verify the accuracy of measure functions of device [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic & Diastolic blood pressure.
|Study Start Date:||October 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Blood Pressure, Heart Rate, Monitor
Device Comparison Test DUT: Transtek Blood Pressure Monitor, LS-802 Refrence Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.
Groups/Cohorts: Blood Pressure & Heart Rate Monitor
Device: Comparison Test to Yuyue Medical BP Meter, YYBP-212
DUT: Transtek Blood Pressure Monitor, LS-802. Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01502553
|Zhongshan City People's Hospital|
|Zhongshan, Guangdong, China, 528403|
|Study Director:||Yuedong Cao, Doctor||Zhongshan City People's Hospital|