Ambu Cuff Pressure Gauge, Instructions For Use Manual

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uring equipment is not available, the metrological control can be carried out by Ambu. In this case the Cuff
Pressure Gauge has to be sent to Ambu.
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 metrologi-
cal 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
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 Ambu for repair. 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 Ambu’s staff. For safety reasons Ambu preserves the right to refuse 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 characteristics 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.