Idiomas disponibles
Idiomas disponibles
CAuTION
Do not immerse the product in liquids.
•
The product cannot be automatic or manual cleaned respectively sterilised.
•
Do not clean the glass (plastic material) with aggressive agents.
•
METROlOGICAl INSpECTION
The accuracy ±2 cmH
required measuring equipment is not available, the metrological control can be carried out by
the manufacturer. In this case the Cuff Pressure Gauge has to be sent to the manufacturer.
If there is an indication that the Cuff Pressure Gauge cannot keep the accuracy of measure-
ment within the 24 months, or the metrological characteristics of the Cuff Pressure Gauge
have been affected, a metrological control has to be carried out immediately. This has to
be carried out only by a person who meets the requirements for metrological controls. The
results of the control, as well as the measured values and measurement procedures has to
be documented.
After successful control, the Cuff Pressure Gauge has to be marked with a sign which indicates
(clearly and traceable) the year of the next inspection and the person who carried out the
metrological control.
In order to check the values, the Luer nozzle of the Cuff Pressure Gauge has to be connected
to a calibrated pressure gauge (measurement inaccuracy max. ±0.6 cmH
Afterwards inflate via the inflation bulb to 30, 60 and 90 cmH
values must be within the indicated tolerance. If this is not the case, the device must be
returned to the service of the manufacturer. If the values are within the tolerance, the device
can still be used.
Note for conversion of cmH
1 cmH
O = 0,98067 hPa
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SERVICE
Prior to return of medical products for complaint/repair, they must be cleaned and disinfected
to exclude any risk for the manufacturer's staff. For safety reasons, the manufacturer preserves
the right to refuse soiled or contaminated products.
STORAGE AND TRANSpORT CONDITIONS
The shelf life of the Cuff Pressure Gauge is 8 years.
The shelf life of the connecting tube is 5 years.
Protect from heat and store in a dry place.
•
Keep away from sunlight and light sources.
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Store and transport in the original packaging.
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MAINTENANCE
The medical product may only be serviced by persons who have the technical knowledge,
qualification and the required means to properly carry out the service.
After service of the medical product, the essential constructive and functional characteristics
O of the Cuff Pressure Gauges must be checked every 24 months. If
2
O to SI-Unit Pascal:
2
-11-
O).
2
O and record the values. The
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