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ASPIRATORE SUPERVEGA EVO

SUPERVEGA EVO SUCTION UNIT

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

[email protected] - [email protected]

www.gimaitaly.com

Made in Italy

28183

0476

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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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