Instructions for use
7
EN
2.3
Essential Performance
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, EN 1060-3
▪
An error is issued in the event that successful
blood pressure measurement is impossible.
The blood pressure monitor does not emit an alarm in
the sense of IEC 60601-1-8. The blood pressure
monitor is not provided to be used in conjunction with
HF surgery monitors or for the clinical monitoring of
patients, such as on an intensive care unit.
Basic safety means that the patient cannot be
endangered by any automatic device procedure.
In the event of an unclear status or state of the blood
pressure monitor, the blood pressure monitor must
enter standby mode by the device releasing the air in
the cuff. The cuff is not automatically pressurised, to
do so, the device must be initiated manually.
See IEC 81060-1 201.4.3.101, IEC 60601-1, sect. 4.2
and IEC 60601-1-2, sect. 6.2.1.10
