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Clinical Study of Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 (BPM_S)

This study has been completed.
BTS International
Information provided by (Responsible Party):
Leo Wang, BTS International Identifier:
First received: December 21, 2011
Last updated: December 29, 2011
Last verified: December 2011

The clinical protocol of the clinical testing of this device:

  1. Objective of the test: To verify the function of device.
  2. Test methods and procedures: Performance test in two positions: Seated and Supine.
  3. DUT: Transtek Blood Pressure Monitor, Model: LS-802. Cuff size: 22-32 cm and 22-42 cm.
  4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
  5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.
  6. Statistical methodology used: Description of statistical methods.
  7. Result: Meet the requirements of SP10.

Condition Intervention
Device: Comparison Test to Yuyue Medical BP Meter, YYBP-212

Study Type: Interventional
Study Design: 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

Further study details as provided by BTS International:

Primary Outcome Measures:
  • 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.

Enrollment: 95
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Brand names: Yuyue
  • Serial numbers: YYBP20100013437
  • Code name: YYBP-212

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • male,female,

Exclusion Criteria:

  • below 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01502553

China, Guangdong
Zhongshan City People's Hospital
Zhongshan, Guangdong, China, 528403
Sponsors and Collaborators
Leo Wang
BTS International
Study Director: Yuedong Cao, Doctor Zhongshan City People's Hospital
  More Information

Additional Information:
Responsible Party: Leo Wang, Director, BTS International Identifier: NCT01502553     History of Changes
Other Study ID Numbers: Trans 2011004
BTS-TRANS04 ( Other Identifier: BTSInternational )
Study First Received: December 21, 2011
Last Updated: December 29, 2011

Keywords provided by BTS International:
blood pressure
heart rate processed this record on April 28, 2017