MESI ABPI MD - Essential Performance

48
STANDARD COMPLIANCE
11.2 ESSENTIAL PERFORMANCE
The MESI ABPI MD’s essential performance is performing an
ABI measurement under specified operating conditions. The
measurement is defined as the measurement process on and
data storage to the MESI ABPI MD device. Due its high sensitivi-
ty, intended use and operating modes, the device is susceptible
to EM interferences. If the essential performance of the device
is decreased, the device will notify the user with error messages
on any issues while the cus (if in use during the adverse event)
will deflate and cause no harm to the patient.