Omron
M3 Comfort AFib (HEM-7196-FLE) *
Preferred devices rules
Preferred devices are upper-arm cuff devices with at least one STRIDE BP approved validation study, which was published within the last 10 years and used a recent protocol (AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018); ANSI/AAMI/ISO 2013 or 2009; ESH-IP 2010). Preferred devices for home use also have automated storage of multiple readings, or mobile phone, PC or internet link connectivity enabling data transfer.
Equivalent/Identical devices rules
Equivalent devices have not been validated but evidence has been provided and approved by the STRIDE BP Scientific Advisory Board showing that they are equivalent to a device that has fulfilled the criteria for validated devices. These devices have minor model differences which do not affect the blood pressure measurement accuracy, such as memory improvement, provision of bluetooth, PC connection, printer facilities, or additional functions. Identical devices have no difference from a STRIDE BP approved device, apart from model name change.
Market Availability
Available
Population
Adults
Diabetics
Pregnancy / Preeclampsia
Use
Home
Measurement Site
Upper arm cuff
Measurement Method
Automated oscillometric
Validated Cuff Sizes (cm)
22-42
Additional Features
Atrial fibrillation detection, Automated duplicate or more measurements, Automated storage of multiple readings, Body movement detection, Wide-range cuff
Validation studies of Omron BP760N (HEM-7320-Z), to which this device is equivalent
Population
Adults
Protocol and version (year)
ANSI/AAMI/ISO 2009
Year of validation study publication
2015
Link
Population
Diabetics
Protocol and version (year)
ESH-IP 2010
Year of validation study publication
2017
Link
Population
Pregnancy / Preeclampsia
Protocol and version (year)
AAMI_ESH_ISO Universal Standard (ISO 81060-2:2018) 2018
Year of validation study publication
2018
Link