Gima SUPERVEGA 28193 User manual

ASPIRATORE SUPERVEGA BATTERY - SU CARRELLO
SUPERVEGA BATTERY SUCTION ASPIRATOR -
ON TROLLEY
ASPIRATEUR SUPERVEGA BATTERY - SUR CHARIOT
ABSAUGER SUPERVEGA BATTERY - AUF TROLLEY
ASPIRADOR SUPERVEGA BATTERY - SOBRE CARRO
M28193-M-Rev.1-01.21
PROFESSIONAL MEDICAL PRODUCTS
0476
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Made in Italy
28193

15 ENGLISH
SUPERVEGA BATTERY SUCTION UNIT is a surgical suction pump with the following electrical character-
istics: 14V 4A with AC/DC (input: 100-240V~ - 50-60Hz – 1.5A) to be used for nasal, oral and tracheal
aspirations in adults or for body liquids in children (for example mucus, phlegm and blood) equipped with 5
wheels with braking device. Thanks to these characteristics and its high performance levels, this device is
particularly suitable for use in hospital wards, in small surgical applications and post-operative treatments. 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. Supplied with an audible alarm and visual tell-tale (luminous LED) to
indicate the battery status. Featuring a body in plastic with high thermal and electrical insulation in compliance
with recently introduced European safety regulations. Supplied with no. 2 complete sterilisable polycarbonate
jugs with overow valve. Features a suction regulator and vacuum gauge located on the front panel.
GENERAL WARNING
Read instruction manual carefully before use.
Only highly qualied staff use reserved.
The instrument must not be disassembled. For a technical service always contact Gima.
Keep off the reach of children or not capable people without supervision.
Full containers must be handled with great care during transfer to the disposal areas, following the local
procedures and regulations.
IMPORTANT SAFETY RULES
1. Check the condition of the unit before each use. The surface of the unit should carefully be 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 which 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 ef-
ciency and safety of the device;
- The device can be used only with the bacteriological lter;
- Never immerge the appliance into water;
- 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 qualied personnel and/or the
GIMA technical service department.
- Don’t use in the presence of inammable 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.
- Prevent children from using the device without proper supervision;
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 dened 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 in-
stalled and used in accordance with the information provided with the accompanying documents: the SU-
PERVEGA 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. WARNING: Do not change this equipment without the permission of the manufacturer GIMA S.p.A. None
of electric or mechanical parts has been designed to be repaired by customers or end-users. Don’t open

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the device, do not mishandle the electric / mechanical parts. Always contact technical assistance
8. 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.
9. The medical device is in contact with the patient by means of a disposable probe (not supplied with the de-
vice). Suction tubes for insertion in the human body purchased separately from the machine should comply
with ISO 10993-1 standards on material biocompatibility.
10. The product and its parts are biocompatible in accordance with the requirements of regulation EN 60601-1.
11. Operation of the device is very simple and therefore no further explanations are required other than those
indicated in the following user manual.
12. 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 specic collection centre in order to be recycled.
CONTRAINDICATIONS
- Before using the SUPERVEGA BATTERY SUCTION UNIT, 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.
- SUPERVEGA BATTERY SUCTION UNIT is not suitable for MRI. Do not introduce the device in MRI envi-
ronments.
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
Model SUPERVEGA BATTERY SUCTION UNIT
Typology (MDD 93/42/EEC) Class IIa Medical device
UNI EN ISO 10079-1 Classication High Vacuum / High Flow
Power Feeding 14V 4A with AC/DC adapter (input: 100-240V~ - 50/60Hz
- 100VA) or Internally powered equipment (Pb Battery
12V 4A)
Current Consumption 4.0A
Maximum Suction Pressure (without jar) -80kPa (-0.80 Bar)
Minimum Suction Pressure (without jar) Less -40kPa (-0.40 bar)
Maximum Suction Flow (without jar) 36 l/min
Insulation Class (when used with the AC/DC adapter) Class II
Insulation Class (when used with an Internal battery) Internally Powered Equipment
Weight 7.98 Kg
Size 320 x 990 (h) x 300 mm
Battery Holding Time 60 minutes
Battery Time Charge 240 minutes
Dimension of silicon aspiration tube Ø 8x14 mm
Accuracy of Vacuum Indicator ± 5%

17 ENGLISH
The technical specications 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 glass-
es) to avoid getting in contact with contaminating substances (after each utilization cycle of the machine).
ACCESSORIES SUPPLIES
• N°2 complete aspiration jar 2000ml
• Conical tting
• Tubes set 8 mm x 14 mm
• Hydrophobic and antibacterial lter
• AC/DC adapter
• European power supply cord for AC/DC adapter
The lter is produced with (PTFE) hydrophobic material to prevent uids entering the pneumatic circuit.
It should be changed immediately if it becomes wet or if there is any sign of contamination or discolouration.
If should also be changed if the unit is used with a patient whose risk of contamination is unknown. Don’t use
the suction unit without the protection lter. If the suction unit is used in an emergency or in a patient where
the risk of contamination is not known the lter must be changed after each use.
The lter is not designed to be decontaminated, disassembled and/or sterilised. If the patient’s pathology is
known and/or no risk of indirect contamination exists, it is advisable to replace the lter after each work shift
or at any rate on a monthly basis even if the device is not used.
WARNING: Suction tubes for insertion in the human body purchased separately from the machine
should comply with ISO 10993-1 standards on material biocompatibility.
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 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
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.
Working Condition Room Temperature: 5 ÷ 35°C
Room Humidity Percentage: 30 ÷ 75% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Altitude: 0 ÷ 2000m s.l.m.
Conservation condition and Transport Room Temperature: - 40°C ÷ 70°C
Room Humidity Percentage: 10 ÷ 100% RH
Atmospheric pressure: 500 ÷ 1060 hPa

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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 specic suction probe. If this device must be
used with a specic 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 (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 procedure:
• 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).
DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER
Disposing of disposable bags:
If the device is tted 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 rmly, 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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