scope:

This document specifies the requirements and methods for the CLINICAL INVESTIGATION of CONTINUOUS NON-INVASIVE AUTOMATED SPHYGMOMANOMETERS used for the DETERMINATION of the BLOOD PRESSURE of a subject. This document covers CONTINUOUS NON-INVASIVE AUTOMATED SPHYGMOMANOMETERS intended for use in all subject populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory BLOOD PRESSURE monitoring, stress testing BLOOD PRESSURE monitoring and BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT or self-measurement as well as use in professional healthcare facility or the EMERGENCY MEDICAL SERVICE ENVIRONMENT (EMS)). This document specifies additional disclosure requirements for the ACCOMPANYING DOCUMENTS of CONTINUOUS NON-INVASIVE AUTOMATED SPHYGMOMANOMETERS that have undergone CLINICAL INVESTIGATION 124 according to this document.