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the employment of the said component. Therefore, after each cleaning cycle, it is up to the final user to verify 

whether the fitting is suitable for reuse. The component must be replaced if there are visible signs of decay in 

the material constituting the said component. 

Service life of the device: More than 30000 hours of operation in accordance with the standard conditions 

of testing and operation. Shelf life: maximum 5 years from the date of manufacture. 

Suction catheter: Single-use device to be used on a single patient. Do not wash or re-sterilize after use. 

Reuse may cause cross-infections. Don’t use after lapse of the sell-by date. 

Lithium-ion battery charge cycles: The lithium-ion battery included in the device is guaranteed for over 

300 charging cycles. When you near the 300 charging cycles, you can ask the manufacturer to check the 

operating status or ask for the battery pack to be replaced to ensure that the component is always in perfect 

condition

WARNING: Suction tubes for insertion in the human body purchased separately from the machine 

should comply with ISO 10993-1 standards on material biocompatibility. 

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 proce-

dure:

•  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).

ENGLISH

Summary of Contents for 28183

Page 1: ...ASPIRATEUR SUPERVEGA EVO ABSAUGER SUPERVEGA EVO ASPIRADOR SUPERVEGA EVO M28183 M Rev 1 01 21 PROFESSIONAL MEDICAL PRODUCTS Gima S p A Via Marconi 1 20060 Gessate MI Italy gima gimaitaly com export gimaitaly com www gimaitaly com Made in Italy 28183 0476 ...

Page 2: ...ontact Gima technical service 2 Before connecting the device always check that the electrical details indicated on the data label and the type of plug used correspond to those of the electrical network to which you intend to connect it 3 Comply with the safety rules indicated for electrical equipment and in particular Use only original accessories and components supplied by the manufacturer Gima i...

Page 3: ... product and its parts are biocompatible in accordance with the requirements of the EN 60601 1 standard 11 The operation of the device is very simple and therefore no further measures are required other than those indicated in the following user manual 12 The lithium ion battery contained within the medical device should not be considered normal household waste Dispose of this component at a suita...

Page 4: ...Replace it when ever you suspect that it may be contaminated and or it becomes wet or discoloured Replace the filter every time it is used if the suction pump is used on patients in unknown pathological situations and where an assess ment of indirect contamination is not possible The filter is not manufactured to be decontaminated dismantled and or sterilised If however the patient s pathology is ...

Page 5: ...ure 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 ...

Page 6: ...nal battery Any operation Performed by non trained personnel may cause danger e g Excessive temperature The device should be checked at least once every 12 months by technical service Every 24 months it is compulsory to have a safety inspection and technical maintenance performed on the device ENGLISH Typical defect Cause Remedy 1 Steady Red Back Light Low battery If equipped with an AC DC power s...

Page 7: ...creen the suction tank and the antibacterial filter WARNING For proper use place the aspirator on a flat stable surface in order to have the full volume of use of the jar and better efficiency of the overflow device Filter assembling Make sure the filter is assembled with the arrows on the side of the patient WARNING The inside of the medical device must be regularly checked for the presence of li...

Page 8: ...ment of separation from the electrical mains even if the device is equipped with an on off button Once the device is in use the power plug must remain accessible to allow another method of disconnection from the electrical mains The device features an energy saving function which allows the device to increase its autonomy and de crease the number of revs of the motor In order to do so it controls ...

Page 9: ...t and fixed activation of the bargraph During the Charge phase Charging cycle complete Remove the device from the support plate of the ambulance Fixed green back light During battery operation Primary status Battery fully charged Battery operation guaranteed Fixed yellow back light During battery operation Intermediate status Battery not fully charged Battery operation guaranteed start the charge ...

Page 10: ...the Function off the device is activated deactivated by pressing the ON OFF key RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES This section contains information regarding the conformity of the compliance with the EN 60601 1 2 Standard 2015 The SUPERVEGA EVO SUCTION UNIT surgical aspirator is an electro medical device that requires particu lar precautions regarding electro magnetic comp...

Page 11: ...nt Immunity Test Level indicated by the EN 60601 1 2 Compliance Level Electromagnetic environment guidance Electrostatic discharge ESD EN 61000 4 2 8kV on contact 15kV in air The device doesn t change its state Floors should be wood concrete or ceramic tile If floors are covered with synthetic ma terial the relative humidity should be at least 30 Electrical fast transient burst EN 61000 4 4 2kV po...

Page 12: ...etermined by an elec tro magnetic study of the sitea could be lower than the level of conformity of each frequency interval b It is possible to check for interference in proximity to devices identified by the fol lowing symbol Note 1 At 80 MHz and 800 MHz the interval with the highest frequency is applied Note 2 These guide lines may not be applicable in all situations The electro magnetic propaga...

Page 13: ... 12 23 For transmitters with a maximum nominal output power not shown above the recommended separation distance in metres m can be calculated using the equation applicable to the transmitter frequency where P is the maximum nominal output power of the transmitter in Watt W depending on the transmitter s manufacturer Note 1 At 80 MHz and 800 MHz the interval with the highest frequency is applied No...

Page 14: ...ed of correctly you will help prevent potentially negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of the battery The recycling of the materials will help to conserve natural resources At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries For more detailed i...

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