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

Leo Wang · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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blood-pressureheart-ratehypertensionna
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.
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