scope:

General

This technical information report (TIR) discusses the potential sources of motion artifact noise affecting manual and automated sphygmomanometers in common professional healthcare environments, as well as potential standardized device evaluation methods for determining the performance of these sphygmomanometers when artifact noise is present. Devices in the scope of this TIR include manual sphygmomanometers, oscillometric devices, auscultatory devices, and devices that utilize doppler ultrasound in the estimation of Systolic and Diastolic arterial blood pressure.

Exclusions

This TIR does not cover artifact noise that is not patient or motion induced. For example, radio frequency interference is outside the scope of this document and is adequately addressed in other US and international regulations.