2010
DOI: 10.1097/mbp.0b013e32833e43ca
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Validation of the TRANSTEK blood pressure monitor TMB-986 for home blood pressure monitoring according to the International Protocol

Abstract: The TRANSTEK blood pressure monitor TMB-986 passed all the phases of the International Protocol both for SBP and DBP and is recommended for home use.

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“…One of the devices (Omron 780N3) has not been validated according to international guidelines, though this device obtained Food and Drug administration 510(k) clearance for overthe-counter use and its technology was deemed substantially equivalent to the technology used in validated devices [32]. Though the device was granted Food and Drug Administration approval for over-the-counter use given the substantial equivalence to a validated home device [33,34], and that we followed best practices for BP measurement to minimize measurement error at the research study visit [28], we acknowledge the potential for error associated with the device.…”
Section: Discussionmentioning
confidence: 99%
“…One of the devices (Omron 780N3) has not been validated according to international guidelines, though this device obtained Food and Drug administration 510(k) clearance for overthe-counter use and its technology was deemed substantially equivalent to the technology used in validated devices [32]. Though the device was granted Food and Drug Administration approval for over-the-counter use given the substantial equivalence to a validated home device [33,34], and that we followed best practices for BP measurement to minimize measurement error at the research study visit [28], we acknowledge the potential for error associated with the device.…”
Section: Discussionmentioning
confidence: 99%