2.3 Essential performance features
The essential performance features are defined as blood pressure measurement with:
Error tolerances of the pressure gauge and measurement results within the required limits according to
IEC 80601-2-30
Maximum change value in blood pressure determination according to IEC 80601-2-30
Power delivery (pressure supply to the cuff) within the set limits according to IEC 80601-2-30
An error is issued if successful blood pressure measurement is not possible.
The device does not trigger any alarms in the sense of IEC 60601-1-8 and is not intended for use together with HF
surgical devices or for clinically monitoring patients, e.g. in an intensive care unit.
In the event that the status or configuration of the device is unclear, the device will go into a safe operating mode,
which causes the device to release the air from the cuff.
The cuff is not automatically pressurised; to do so, the device must be initiated manually.
Instruction notes
EN
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