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SAFETY INFORMATION (cont.)
The device has been evaluated clinically using manual cuff/stethoscope
auscultation as the reference. Blood pressure measurements determined
with this device are equivalent to those obtained by a trained observer
using the cuff / stethoscope auscultatory method, within the limits
prescribed by the American National Standard, manual, electronic, or
automated sphygmomanometers.
The materials of the cuff have been tested and found to comply with
requirements of ISO 10993-5:2009 and ISO 10993-10:2010.
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