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Service life of the device: more than 1000 hours of operation (or 3 years) in accordance with the standard
conditions of testing and operation. Shelf life: maximum 5 years from the date of manufacture.
WARNING: The medical device is provided without a specific suction probe. If this device must be
used with a specific suction probe, the end user is responsible for making sure it complies with the
EN 10079-1 regulation.
CLEANING OF ACCESSORIES
Before using the device, the manufacturer advises you to clean and/or sterilize the accessories.
Washing and / or cleaning the autoclavable jar as to be carried out as follows:
• Wear protection gloves and apron (glasses and face mask if necessary) to avoid contact with contaminat-
ing substances;
• Disconnect the tank from the device and remove the said container from the support of the device.
• Separate all the parts of the cover (overflow device, washer).
• Disconnect all tubes from the jar and the protection filter
• Wash each part of the container from secretions under cold running water and then clean every single part
in hot water (temperature not exceeding 60°C)
• Once again, carefully wash each single part using, if necessary, a non-abrasive brush to remove any de-
posits.
Rinse with hot running water and dry all parts with a soft cloth (non-abrasive). It is possible to wash with
commercial disinfectants by carefully following the instructions and dilution values supplied by the manu-
facturer.
After cleaning, leave the parts to dry in an open, clean environment.
• Dispose of the aspiration catheter according to that provided by local laws and regulations.
The silicone aspiration tubes and the conical fitting may be carefully washed in hot water (temperature must
not exceed 60°C). After cleaning, leave the parts to dry in an open, clean environment.
When cleaning is complete, reassemble the container for liquid aspirations according to the following procedure:
• Place the overflow valve into its seat in the cover (under VACUUM connector)
• Insert floating valve keeping the o-ring towards the opening of the cage
• Place the o-ring into its seat around the cover
• After completing assembling operations always make sue that cover seals perfectly to avoid vacuum leack-
ages or liquid exit
The jar and the cover can be autoclaved by placing the parts into the autoclave and running one sterilization
stem cycle at 121°C (1 bar relative pressure – 15 min) making sure that the jar is positioned upsidedown.
Mechanical resistance of the jar is guaranteed up to 30 cycles of sterilization and cleaning at the indicated
conditions (EN ISO 10079-1). Beyond this limit the physical-mechanical characteristics of the plastic may
decrease and replacement of the part is therefore recommended.
After sterilization and cooling at environment temperature of the parts make sure that these are not damaged.
The aspiration tubes can be sterilized on autoclave using a sterilization cycle at 121°C (1 bar relative pres-
sure – 15 min).
The conical connector can be sterilized on autoclave using a sterilization cycle at 121°C (1 bar relative pres-
sure – 15 min).
DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER
Disposing of disposable bags:
If the device is fitted with FLOVAC® disposable collection systems (consisting of a rigid, reusable polycar-
bonate container and a single-use polyethylene collection bag), proceed with the disposal of the bag as follows:
Deactivate the suction source and remove all tubes connected to the container, paying particular attention to
avoid accidental contamination. Attach the plugs to the “PATIENT” and “TANDEM” connectors by inserting
them firmly, paying particular attention to avoid accidental contamination. Take the device to the waste collec-
tion area with all the openings correctly sealed, taking into consideration that the product may potentially be
infected. Discard the product in compliance with the regulations in force at the hospital.
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