Gima SUPERVEGA BATTERY 230/12V Instruction manual
PROFESSIONAL MEDICAL PRODUCTS
ASPIRATORE SUPER VEGA BATTERY
SUPER VEGA BATTERY SUCTION UNIT
ASPIRATEUR SUPER VEGA BATTERY
SAUGER SUPER VEGA BATTERY
ASPIRADOR SUPER VEGA BATTERY
ASPIRADOR SUPER VEGA BATTERY
SSAK AKUMULATOROWY SUPER VEGA BATTERY
ASPIRATOR SUPER VEGA BATTERY
ΣΥΣΚΕΥΗ ΑΝΑΡΡΟΦΗΣΗΣ SUPER VEGA BATTERY
M28243-M-Rev.2-09.20
28243
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Italy
0476
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SUPER VEGA BATTERY SUCTION UNIT is a suction pump particularly suited for use in hospital wards,
in patients with tracheotomy, in small surgical applications and post-operative treatments at home. A device
that can be used for nasal, oral and tracheal aspirations in adults or for body liquids in children (for example
mucus, phlegm and blood). A device designed to offer ease-of-transport and almost continuous use thanks
to the adoption of an electronic system to manage the power supply. The luminous LED positioned on the
front panel indicates its activation and the charge status of the device. Its body is made from plastic with high
thermal and electrical insulation in compliance with recently introduced European safety regulations. Supplied with sterilizable polycarbonate jug with overow valve. Features a suction regulator and vacuum gauge
located on the front panel.
ENGLISH
GENERAL WARNING
Read instruction manual carefully before use.
The device is for use by qualied 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.
IMPORTANT SAFETY RULES
1. Check the condition of the unit before each use. The surface of the unit should carefully inspected for visual
damage.
Check the mains cable and do not connect to power if damage is apparent;
2. Before connecting the appliance always check that the electric data indicated on the data label and the type
of plug used, correspond to those of the mains electricity to witch it’s to be connected;
3. Respect the safety regulations indicated for electrical appliances and particularly:
- Use original components and accessories provided by the manufacturer to guarantee the highest efciency and safety of the device;
- The device can be used only with the bacteriological lter;
- Never immerge the appliance into water;
- Do not place or store the aspirator in places where it may fall or be pulled into the bathtub or washbasin.
In the event it is accidentally dropped, do not attempt to remove the device from the water whilst the plug
is still connected: disconnect the mains switch, remove the plug from the power supply and contact the
GIMA technical service department. Do not attempt to make the device work before it has been thoroughly checked by qualied personnel and/or the GIMA technical service department.
- Position the device on stable and at surfaces in a way that the air inlets on the back aren’t obstructed;
- To avoid incidents, do not place the aspirator on unstable surfaces, which may cause it to accidentally fall
and lead to a malfunction and/or breakage. Should there be signs of damage to the plastic parts, which
may expose inner parts of the energised device, do not connect the plug to the electrical socket. Do not
attempt to make the device work before it has been thoroughly checked by qualied personnel and/or the
GIMA technical service department.
- Don’t use in the presence of inammable substances such as anaesthetic, oxygen or nitrous oxide;
- Don’t touch the device with wet hands and always prevent the appliance coming into contact with liquids;
- Don’t leave the appliance connected to the power supply socket when not in use;
- 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 places protected against the weather and far from any sources of heat. After
each use, it is recommended to store the device in its own box away from dust and sunlight.
- 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.
4. For repairs, exclusively contact technical service and request the use of original spare parts.
Failure to comply with the above can jeopardise the safety of the device;
5. Use only for the purpose intended. Don’t use for anything other than the use dened by the manufacturer.
The manufacturer will not be responsible for damage due to improper use or connection to an electrical
system not complying with current regulation.
6. The medical device requires special precautions regarding electromagnetic compatibility and must be installed and used in accordance with the information provided with the accompanying documents: the SU-
ENGLISH
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PER VEGA BATTERY SUCTION UNIT device must be installed and used away from mobile and portable
RF communication devices (mobile phones, transceivers, etc.) that may interference with the said device.
7. Instrument and accessory discharging must be done according to current regulations in the country of use.
8. WARNING: Do not change this equipment without the permission of the manufacturer GIMA S.p.A. None of
electric or mechanical parts have been designed to be repaired by customers or end-users. Don’t open the
device, do not mishandle the electric / mechanical parts. Always contact technical assistance
9. Using the device in environmental conditions different than those indicated in this manual may harm seri-
ously the safety and the technical characteristics of the same.
10. The medical device is in contact with the patient by means of a disposable probe (not supplied with the
device).
Suction tubes for insertion in the human body purchased separately from the machine should comply with
ISO 10993-1 standards on material biocompatibility.
11. The product and its parts are biocompatible in accordance with the requirements of regulation EN 60601-
1.
12. Operation of the device is very simple and therefore no further explanations are required other than those
indicated in the following user manual.
13. The lead battery integrated in the device is not to be considered as an ordinary domestic waste. Such a
component must be disposed of in a specic collection centre in order to be recycled.
14. 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.
15. 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 modied, repaired without authorization or should any of its component be damaged due to accident or misuse.
Any minimal modication / 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 subsequent changes)
and its normatives.
CONTRAINDICATIONS
- Before using the ASPIRATOR, consult the instructions for use: failure to read all the instructions in this
manual can be harmful for the patient.
- The device cannot be used to drain chest uids;
- The device must not be used for suction of explosive, corrosive or easily ammable liquids.
- ASPIRATOR is not suitable for MRI. Do not introduce the device in MRI environments.
TECHNICAL CHARACTERISTICS
Model SUPERVEGA BATTERY 230/12V
Typology (MDD 93/42/EEC) Class IIa Medical device
UNI EN ISO 10079-1 Classication
Power Feeding 14V
Maximum Suction Pressure (without jar) -75kPa (- 0.75 bar)
Minimum Suction Pressure (without jar) Less -25kPa (-0.25 bar)
Maximum Suction Flow (without jar) 16 l /min
Weight 3.50 Kg
Insulation Class (when used with the AC/DC adapter) Class II
HIGH VACUUM / LOW FLOW
- 100VA) or Internally powered equipment (Pb Battery
12V
4A with AC/DC adapter (input: 100-240V~ - 50/60Hz
4A) or with cigarette lighter adapter (12V 4A)
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Insulation Class (when used with an Internal battery) Internally Powered Equipment
Insulation Class (when used with a car cigarette
lighter cable)
Size 350 x 210 x 180 mm
Battery Holding Time 80 minutes
Battery Time Charge 240 minutes
Accuracy of Vacuum Indicator ± 5%
Working Condition Room temperature: 5 ÷ 35°C
Conservation condition and Transport Room temperature: - 25 ÷70°C
Class II
Room humidity percentage: 10 ÷ 93 % RH
Atmospheric pressure: 800 ÷ 1060 hPa
Room humidity percentage: 0 ÷ 93% RH
Atmospheric pressure: 500 ÷ 1060 hPa
ENGLISH
The technical specications may change without notice
CLEANING OF THE DEVICE
Use a soft dry cloth with not – abrasive and not – solvent detergents. To clean the device external parts always
use a cotton cloth dampened with detergent. Don’t use abrasive or solvent detergents. Before carrying out
any cleaning and / or maintenance operation, disconnect the appliance from the power supply, unplugging it
or turning off the switch on the device.
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 under water.
During all clearing operations use protection gloves and apron (if need be, also wear a face mask and glasses) 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 6 mm x 10 mm
• Hydrophobic and antibacterial lter
• AC/DC adapter
• Power supply cord for ac/dc adapter
• Cigarette ligther cable
On request, versions with a complete 2000ml jar are also available.
Antibacterial and hydrophobic lter: designed for a single patient with the aim of protecting patient and
machine against infections cross. It blocks the passage of the liquids that come into contact with it. Always
replace it if yes suspected to be contaminated and / or wetted or discolored. If the aspirator is used on patients
in pathological situations not known and where it is not possible to assess any indirect contamination, replace
the lter after each use. The lter is not designed to be decontaminated, disassembled and / or sterilized.
In case the pathology of the patient and / or is knownwhere there is no danger of indirect contamination, we
recommend replacing the lter after each work shift or otherwise every month even if the device is not used.
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
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