VBM MONITOR, Instructions For Use Manual

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trol 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
measurement 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 require -
ments 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 per -
son 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
2
O).
Afterwards inflate via the inflation bulb to 30, 60 and 90 cmH
2
O and record the
values. The 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
2
O to SI-Unit Pascal: 1 cmH
2
O = 0,98067 hPa
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.
• Store and transport in the original packaging.
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 char -
acteristics for safety and functionality have to be checked, insofar as they can be
influenced by the service procedure.
To ease repair of the medical product, return it together with a detailed description
of the defect.
DISPOSAl
Used or damaged products must be disposed in accordance with the applicable
national and international regulations.