Gima SUPERVEGA EVO User manual

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
[e-mail] - [e-mail]
www.gimaitaly.com
Made in Italy
28183 0476

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SUPERVEGA EVO is a desk-type electric suction unit for the aspiration of body liquids (such as mucus ,
phlegm and blood), oral, nasal and tracheal aspiration in adults or children. Its shape, elegantly narrow, is
motly designed for tting into ambulance care and emergency use.
This device has been designed to offer ease of transport and continuous use, thanks to an electronic system
that manages the power supply. The large LCD display facilitates the use of the device and increases suction
by adjusting the control buttons.
The signal on the LCD screen, placed on the front panel, allows you to monitor the charge status of the
Lithium battery. The lithium battery and the innovative Feedback system, which guarantees a smart use by
automatically controlling and adjusting the suction power, allow the battery to increase its autonomy and
decrease the noise produced.
The “PROXIMITY” function allows the device to be activated/deactivated via an infra-red proximity sensor
(detecting the presence of the hand from a distance of tenths of centimetres without touching the suction
unit) and it prevents and avoids possible crosscontamination between patients as they are treated in turns.
Made of highly heat resistant, electrically insulated plastic material in conformity with the latest European
safety standard, the product is supplied with a complete polycarbonate autoclavable jar with overow valve.
GENERAL WARNING
Read instruction manual carefully before use.
A careful and correct use ensures optimal operation of the device.
The device is for use by qualied personnel (surgeon / professional nurse / assistant). The use of the device
at home is restricted to an adult in full possession of mental faculties and / or home carers.
The instrument must not disassembled. For technical service always contact Gima S.p.A.
BASIC SAFETY RULES
1. When opening the packaging, check the integrity of the device, paying particular attention should there
be any damage to the plastic parts, which could make accessible the internal parts of the device under
voltage, and to breakage and/or peeling of the power cable. In case of any damage, do not connect the
plug to the electrical socket. To replace it, contact 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 in order to ensure
maximum efciency and safety of the device.
- Always use the medical device with the antibacterial lter supplied by the manufacturer Gima in order to
ensure maximum efciency and safety of the device.
- Never immerse the device in water or other liquids.
- Do not use the device in environments where there are ammable anaesthetic mixtures with air, oxygen
or nitrous oxide which could cause explosions and/or res.
- Do not place the aspirator on unstable operating surfaces whose accidental fall could cause malfunctions
and/or breakages. Should there be any damage to the plastic parts, which could make accessible the
internal parts of the device under voltage, do not connect the plug to the electrical socket. Do not
try to operate the device before it has undergone a thorough check by qualied personnel and/or by the
Gima technical service.
- Do not use the device in environments where there are ammable anaesthetic mixtures with air, oxygen
or nitrous oxide which could cause explosions and/or res.
- Avoid touching the device with wet hands and in any case always ensure that the device does not come
into contact with liquids.
- Prevent children and/or incapacitated users from using the device without due supervision.
- Don’t pull the power supply cable to disconnect the plug remove the plug from the mains socket correctly.
- Store and use the device in weatherproof environments and away from any heat sources.
- The device cannot be used to drain chest uids.
- In general, it is inadvisable to use single or multiple adapters and/or extensions. Should their use be
necessary, you must use ones that are in compliance with safety regulations, however, taking care not to
exceed the maximum power supply tolerated, which is indicated on the adapters and extensions.
- Never leave the appliance near water, do not immerse it in any liquid. If the device has fallen into water,
unplug it before you hold it. Do not use the appliance if the plug or AC / DC power supply is damaged or

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wet (send it immediately to an authorized service center or technical service).
4. For repairs, exclusively contact Gima technical service or a technical assistance centre authorised by the
manufacturer and only original spare parts may be used. Failure to comply with the above may compro-
mise the safety of the device.
5. This device must only be used for its intended use and as described in this manual. Any use other
than that for which the device is intended must be considered improper and therefore dangerous; the man-
ufacturer cannot be held liable for damages caused by improper, erroneous and/or unreasonable use or if
the device is used in electrical systems which do not comply with current safety standards.
6. The medical device requires special precautions regarding electromagnetic compatibility and must be in-
stalled and used according to the information provided with the accompanying documents: the device must
be installed and used away from mobile and portable RF communication devices (cell phones, transceiv-
ers, etc.) that could affect the device itself.
7. WARNING: Do not modify this device without the manufacturer’s authorisation. No electrical and/or me-
chanical part contained in the device has been designed to be repaired by the user. Failure to comply with
the above may compromise the safety of the device.
8. The use of the device in environmental conditions other than those indicated in this manual can seriously
affect its safety and technical parameters.
9. The medical device comes into contact with the patient through the single-use probe. Any suction cannulas
that enter the human body, purchased separately from the machine, must comply with the requirements of
ISO 10993-1.
10. The 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 suitable collection point for its recycling.
13. Use in Home-Care: Keep all accessories of the device out of reach of children under 36 months of age
since they contain small parts that may be swallowed.
14. Do not leave the device unattended in places accessible to children and/or persons not in full possession
of mental faculties as they may strangle themselves with the patient’s tube and/or the power cable.
The manufacturer cannot be held liable for accidental or indirect damages should the device
be modied, repaired without authorization or should any of its component be damaged due to ac-
cident or misuse. Any minimal modication / repair on the device voids the warranty and does not
guarantee the compliance with the technical requirements provided by the MDD 93/42/EEC (and sub-
sequent changes) and its normatives.
TECHNICAL CHARACTERISTICS
Modell SUPERVEGA EVO
Typology (MDD 93/42/EEC) Class IIa Medical device
UNI EN ISO 10079-1 CLASSIFICATION High vacuum / High ow
Power Feeding 14V 4A with AC/DC adapter (input: 100-240V~
- 50/60Hz - 100VA) or Internally powered equipment
(Li-Ion battery 14.8V 5.2A) or with cigarette
lighter adapter (12V 4A)
Maximum Suction Pressure (adjustable) -75kPa (-0.75 Bar)
Minimum Suction Pressure (adjustable) -15kPa (-0.15 bar)
Maximum Suction Flow 26 l/min
Insulation Class (when used with the SUPPORT BRACKET) Class II
Insulation Class (when used with an Internal battery) Internally Powered Equipment
Weight 2.70 Kg
Size 350 x 210 x 180mm
Battery Holding Time 70 minuti
Battery Time Charge 360 minutes

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The technical specications may change without notice.
Please note that if the device is used at an altitude higher than 2.500 m asl, the yield intended as
suction ow may vary sensitively due to the decrease in atmospheric pressure.
MAIN UNIT CLEANING OPERATIONS
To clean the outside of the device, use a cotton cloth moistened with a detergent.
Do not use abrasive cleaning substances and solvents. Before carrying out any cleaning and/or maintenance
operation, disconnect the device from the power supply, by unplugging or turning off the device switch.
Particular care should be taken to ensure that the internal parts of the equipment do not get in
touch with liquids. Never clean the equipment with water.
During all clearing operations use protection gloves and apron (if need be, also wear a face mask and glass-
es) to avoid getting in contact with contaminating substances (after each utilization cycle of the machine).
ACCESSORIES SUPPLIES
• Complete aspiration jar 1000ml
• Conical tting
• Tubes set 8x14 mm
• Hydrophobic and antibacterial lter
• AC/DC adapter
• Power supply cord for AC/DC adapter
• Cigarette ligther cable
Available under request with different versions with complete jar 2000ml.
Anti-bacterial and hydrophobic lter: designed for the individual patient to protect patient and machine from
cross-infections. Prevents the liquids, that come into contact with it, from passing through it. Replace it when-
ever you suspect that it may be contaminated and/or it becomes wet or discoloured. Replace the lter 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 lter is not manufactured to be decontaminated, dismantled
and/or sterilised. If, however, the patient’s pathology is known and/or there is no risk of indirect contamination,
the lter should be replaced after every work shift or once a month even if the device is not used.
Aspiration jar: The mechanical resistance of the component is guaranteed up to 30 cycles of cleaning and
sterilization. Beyond this limit, the physical-chemical characteristics of the plastic material may show signs of
decay. Therefore, we recommend that you to change it.
Silicone tubes: the number of cycles of sterilization and/or cleaning is strictly linked to the employment of the
said tube. Therefore, after each cleaning cycle, it is up to the nal user to verify whether the tube is suitable
for reuse. The component must be replaced if there are visible signs of decay of the material constituting the
said component.
Conical tting: the number of cycles of sterilization and the number of cleaning cycles is strictly linked to
Working Condition Room temperature: 0 ÷ 40°C
Room humidity percentage: 0 ÷ 85% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Conservation condition and transport Room temperature (≤ 1 mounth): : - 20°C ÷ 45°C
Room temperature (≤ 3 mounth): - 20°C ÷ 35°C
Room temperature (≤ 1 year): 0°C ÷ 25°C
Room humidity percentage: 0 ÷ 85% RH
Atmospheric pressure: 500 ÷ 1060 hPa

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the employment of the said component. Therefore, after each cleaning cycle, it is up to the nal user to verify
whether the tting 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 (overow device, washer).
• Disconnect all tubes from the jar and the protection lter
• 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 tting 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 overow valve into its seat in the cover (under VACUUM connector)
• Insert oating 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).
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