Improper Use; Essential Performance - IEM Tel-O-Graph GSM Mode D'emploi

Improper Use

The blood pressure measuring device must not be used for newborn infants or children under the age of 12, must
not be used for surgery, must not be used near a magnetic resonance imaging scanner or other strong magnetic
field, and must not be used for monitoring patients within a clinical context or during their transport.
The blood pressure measuring device must be kept out of the reach of unsupervised children and must not be used
on people deemed legally incompetent.
It must not be used for any other purpose than the blood pressure measurement procedure described here and
must not be used in vehicles or aircraft!
The Tel-O-Graph ® GSM is not designed to be used on pregnant women or in cases of pre-eclampsia.
Note
▪ There are currently no clinical studies available on the use of pulse wave analysis in children. Accordingly,
there is no confidence interval for persons under the age of 20 years.
If you are taking medication to alter blood clotting, consult your physician before using the blood pressure
▪
monitor.

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
▪
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 RF surgery monitors or for the clinical monitoring of patients, such as
on an intensive care unit.
Instruction Notes
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