27 Jul 1.23 P1–0 Requirement 1.1.29 to 33 Is it mandatory for the triage tag to display in real time vital signs as the tag will act as a vital sign monitor and so will require separate medical device accreditation as well as requiring a power source, be prohibitively expensive in terms of supply and maintenance as well as in field distribution difficulties?
Triage Tag Essential Information displays the colour/status of the casualty after having performed the first triage. It would be appreciated to have the following Triage Tag Extended Information:
display the heart rate; respiratory rate; display the arterial oxygen saturation; display the blood pressure.
The certification of the components as Medical Devices (MD) is not required at this stage, but if the solution involves the integration and use of software / App / Devices, already on the market, which correspond to the definition of Medical Device, then they must be certified.