Directions For Use; Intended Use; Improper Use; Essential Performance Features - IEM Mobil-O-Graph PWA Operating Manual

Directions for use

2 Directions for use

2.1 Intended use

The intended use is 24-hour blood pressure measurement and pulse wave analysis (PWA).
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The Mobil-O-Graph is only to be used under medical supervision by medical personnel.

2.2 Improper use

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The Mobil-O-Graph
pressure described herein.
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Due to the risk of strangulation by the tube and cuff, the Mobil-O-Graph
unsound mind and must not be left within reach of unsupervised children.
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The Mobil-O-Graph
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The Mobil-O-Graph
in intensive care units.
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The Mobil-O-Graph
Note
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The Mobil-O-Graph has not been tested for use on pregnant women or those suffering from preeclampsia.

2.3 Essential performance features

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, EN 1060-3
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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.
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must not be used for any purpose other than the process of measuring blood
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is not intended for use on babies and children under the age of 3.
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must not be used for alarm-triggering blood pressure monitoring during operations or
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must not be used on aeroplanes!
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must not be used on patients of