Instruction Notes
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EN
The Tel-O-Graph
®
BT is not designed to be used on pregnant women or in cases of pre-eclampsia.
Note
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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:
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Error tolerances of the pressure gauge and measurement results within the required limits according to IEC
80601-2-30.
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Maximum change value in blood pressure determination according to IEC 80601-2-30.
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Power delivery (pressure supply to the cuff) within the set limits according to IEC 80601-2-30.
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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.
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 pressurized, to do so, the
device must be initiated manually.
