General Warning; Important Safety Rules - Gima SUPERVEGA EVO Manual De Istrucciones

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 fitting 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 cross-
contamination 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 overflow valve.
THE DEVICE IS FOR USE BY QUALIFIED PERSONNEL (SURGEON / PROFESSIONAL NURSE / ASSISTANT)
THE INSTRUMENT MUST NOT DISASSEMBLED. FOR TECHNICAL SERVICE ALWAYS CONTACT GIMA S.P.A.
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 efficiency and safety
of the device;

The device can be used only with the bacteriological filter;

Never immerge the appliance into water;

Position the device on stable and flat 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 qualified personnel and/or the GIMA technical service department.

Don't use in the presence of inflammable 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;

Store and use the device in places protected against the weather and far from any sources of heat.

Don't use the device thoracic drainage.
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 defined 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 SUPERVEGA EVO 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 seriously 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 (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 specific collection centre in order to be recycled.

GENERAL WARNING

READ INSTRUCTION MANUAL CAREFULLY BEFORE USE.

IMPORTANT SAFETY RULES

19
GB