Metrological Inspection - Medizintechnik VBM Manual Del Usuario

the red release valve and pressure decrease via the inflation bulb.
ExTUbATIoN
Before extubation attach the inflation line to the vacuum valve and squeeze the
inflation bulb until it does not return to its original position. In order to check for
complete deflation, attach the inflation line to the Luer nozzle of the cuff pressure
gauge. The needle of the Cuff Pressure Gauge has to show a negative pressure
by moving counter-clockwise. Only then the cuff is completely deflated and the
patient can be extubated.
wIPE DISINFECTIoN
Wipe disinfection using conventional surface disinfectants based on alcohol (e.g.,
Incides N from Ecolab Deutschland GmbH) is suitable for disinfection. When
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choosing a product for disinfection, a disinfectant with appropriate ranges of action
must be used: bactericidal, yeasticidal, tuberculocidal and virucidal. After the wipe
disinfection, the devices must be inspected for visible contamination. If neces-
sary, repeat the wipe disinfection. After the wipe disinfection, the devices must be
checked in accordance with the section „Functional check".
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
24 months. If required measuring equipment is not available, the metrological con-
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
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 O).
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Afterwards inflate via the inflation bulb to 30, 60 and 90 cmH
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.
O of the Cuff Pressure Gauges must be checked every
2
-12-
O and record the
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