Test Equipment; Technical Measurement Check - Riester ri-vital Mode D'emploi

14. TECHNICAL MEASUREMENT CHECK

Germany:
Pursuant to the Ordinance on Operating Medical Devices (Medizinprodukte-
Betreiberverordung, MPBetreibV), a technical check must be conducted in two-year
intervals. The check can only be conducted by the manufacturer, the appropriate
authorities or persons who comply with the requirements of MPBetreibV §6.
European Union outside of Germany:
The respective legal provisions apply for all EU countries outside of Germany.
Technical measurement check for the predictive thermometer
The probe accuracy can be checked using a calibrated water bath
(the probe cover must be attached!).
Thermometers which are out of the error threshold must be checked in Direct Mode.
The switch to this mode is done automatically when the probe is placed out of the
waterbath for approx. 60s.
Technical measurement check for the blood pressure monitor:
1. Procedure for checking compliance with the error threshold of the reading display of
the cuff pressure

1.1 Test equipment

a) Solid metal container with a capacity of 500 ml +/- 5%.
b) Calibrated control manometer with a maximum permissible error of measurement
of 1.0 mmHg (0.1 kPa)
c) Pressure generator, e.g. pump ball with discharge valve.
d) T pieces and tubes.
1.2 Procedure
a) Replace the device's cuff with the metal container (see 1.1a).
Connect the calibrated control manometer (see 1.1b) with the cuff connector (see Fig.
1) by means of a T piece and tubes (see 1.1d).
Connect the additional pump ball (see 1.1c) to the pneumatic system with the help of
another T piece.
In order to get to the calibration mode (manometer mode), turn the device off and
press the On/Off button, the Riester logo now appears on the screen; the Print
button must be pressed within 5 seconds in order to arrive in the basic settings.
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TECHNICAL MEASUREMENT CHECK
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