Gima SUPERVEGA EVO BATTERY ASPIRATOR User manual
GB
17
SUPERVEGA EVO BATTERY ASPIRATOR is a surgical aspirator with the following electrica features : 14V 4A with AC/DC
adapter mod. UE60-140429SPA1 of FUHUA (input: 100-240V~ - 50/60Hz - 100VA) or Internally powered equipment (Li-Ion
Battery 14.8V 5.2A) or with cigarette lighter adapter (12V 4A). SUPERVEGA EVO BATTERY ASPIRATOR is a desk-
type electric suction unit for the aspiration of body liquids, oral, nasal and tracheal aspiration in adults or children. 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.
GENERAL WARNING
READ INSTRUCTION MANUAL CAREFULLY BEFORE USE.
THE DEVICE IS FOR USE BY QUALIFIED 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 efficiency and safety
of the device;
The device can be used only with the bacteriological filter;
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 qualified personnel
and/or the GIMA technical service department.
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;
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.
Don’t use the device thoracic drainage.
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 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.
GB
18
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 (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 specific 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 modified,
repaired without authorization or should any of its component be damaged due to accident or misuse.
Any minimal modification / 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.
IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC
DIRECTIVE 2012/19/UE-RAEE: The symbol on the device indicates the separated collection of electric and
electronic equipment. At the end of life of the device, don’t dispose it as mixed solid municipal waste, but
dispose it referring to a specific collection centre located in your area or returring it to the distributor, when
buying a new device of the sample type to be used with the same functions. This procedure of separated
collection of electric and electronic devices is carried out forecasting a European environmental policy aiming
at safeguarding protecting and improving environment quality, as well as avoiding potential effects on human
health due to the presence of hazardous substances in such equipment or to an improper use of the same or of
parts of the same. Caution: The wrong disposal of electric and electronic equipment may involve sanctions.
TECHNICAL CHARACTERISTICS
Model
SUPERVEGA EVO BATTERY ASPIRATOR
Typology (MDD 93/42/EEC)
Class IIa Medical device
UNI EN ISO 10079-1 Classification
HIGH VACUUM / HIGH FLOW
Power Feeding
14V 4A with AC/DC adapter mod. UE60-140429SPA1
of FUHUA (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
Weight
2.70 Kg
Insulation Class (when used with AC / DC adapter or when
connected to a car cigarette lighter cable))
Class II
Insulation Class (when used with an Internal battery)
Internally Powered Equipment
Size
350 x 210 x 180 mm
Battery Holding Time
70 minutes
Battery Time Charge
360 minutes
Working Condition
Room temperature: 0 ÷ 40 °C
Room humidity percentage: 0 ÷ 85% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Altitude: 0 ÷ 2000m s.l.m.
Conservation condition and Transport
Room temperature (≤ 1 mounth): : - 20 ÷ 45 °C
Temperatura ambiente (≤ 3 mounth): - 20°C ÷ 35°C
Temperatura ambiente (≤ 1 year): 0°C ÷ 25°C
Room humidity percentage: 0 ÷ 85% RH
Atmospheric pressure: 500 ÷ 1060 hPa
Please note that if the device is used at an altitude higher than 2,500 m asl, the yield intended as suction flow may vary sensitively
due to the decrease in atmospheric pressure.
GB
19
SYMBOLS
Insulation Class II (when used with AC / DC adapter or when connected
to a car cigarette lighter cable)
CE marking in conformity with EC directive 93/42/CEE and subsequent
changes
General warnings and/or specifications
Consult the instruction manual
Manufacturer: Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
Applied Part type BF (suction probe)
Keep in a cool, dry place
Conservation temperature
Atmospheric Pressure
Battery (Li-Ion Battery 14,8V 5.2A)
Direct Current
ON / OFF
Batch production
Serial number
Model / Ref number
Device approved according to international standards ECE-R10
IP21
Degree of protection an electrical device provides in the case of
accidental or intentional contact with the human body or with objects,
and protection in the case of contact with water.
1st DIGIT
PENETRATION OF SOLIDS
2nd DIGIT
PENETRATION OF LIQUIDS
Protected against solids having a
dimension greater than Ø 12mm
Protected against the vertical
flow of drops of water
DISPOSAL OF WASTE BATTERIES - (Directive 2006/66/EC)
This symbol on the battery or on the packaging indicates that the battery provided with this product shall not be
treated as household waste. By ensuring these batteries are disposed 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 information about recycling of this product or battery, please contact your local Civic
Office, your household waste disposal service or the shop where you purchased the product.
CLEANING 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.
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 glasses) to avoid getting in
contact with contaminating substances (after each utilization cycle of the machine).
10R-041439
GB
20
ACCESSORIES SUPPLIES
DESCRIPTION
CODE
COMPLETE ASPIRATION JAR 1000ml
RE 210001/02
CONICAL FITTING
RE 210420
TUBES SET 8 mm x 14 mm
51100/01
HYDROPHOBIC AND ANTIBACTERIAL FILTER
SP 0121
SUCTION PROBE CH20
25723
AC/DC ADAPTER (UE60-140429SPA1)
SP 0208/01
POWER SUPPLY CORD FOR AC/DC ADAPTER
SP 0020/03
CIGARETTE LIGTHER CABLE
SP 0007/02
The filter is produced with (PTFE) hydrophobic material to prevent fluids 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 filter. If the suction
unit is used in an emergency or in a patient where the risk of contamination is not know the filter must be changed after each use.
Available under request with different versions with complete jar 2000ml.
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
Check the expiry date on the original packaging of the suction catheter and check the integrity of the sterile
packaging. GIMA declines any liability for injury to the patient correlated to the deterioration of the above-
mentioned sterile packaging due to handling of the original packaging by third parties.
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 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 final 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 fitting: 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 final user to verify whether the fitting 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 manufactured.
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 contaminating 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 (overflow device, washer).
Disconnect all tubes from the jar and the protection filter
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 deposits.
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 manufacturer.
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 fitting 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 overflow valve into its seat in the cover (under VACUUM connector)
Insert floating 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 leackages or liquid
exit
GB
21
After disposing of disposable parts and disassembling the jar wash in running cold water and rinse thouroughly.
Then soak in warm water (temperature shall not exceed 60°C). Wash thouroughly and if necessary use a non-abrasive brush to
remove incrustations. Rinse in running warm water and dry all parts with a soft cloth (non-abrasive).
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 pressure –15 min).
The conical connector can be sterilized on autoclave using a sterilization cycle at 121°C (1 bar relative pressure –15 min).
DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER
PERIODICAL MAINTENANCE CHECKS
The SUPERVEGA EVO BATTERY ASPIRATOR suction equipment does not need maintenance or lubrication.
It is, however to inspect the unit before each use. With regard to training, given the information contained in the user manual and
since it is easy to understand the said device, it doesn’t appear to be necessary. Unpack the instrument and always check integrity
of plastic parts, they might have been damaged during previous use.
Turn switch on and verify that loud noises are not present, these can indicate wrong functioning.
Make sure you do not hear excessively annoying noises that may highlight a malfunction.
The device is protected by a safety fuse (F 10A L 250V) situated in the cigarette lighter cable. When replacing, always check the
type and value as indicated.
Internally, the device is protected (see electrical specifications) by two fuses (T 15A L 125V) that cannot be reached from the
outside. Therefore, contact the manufacturer to request the assistance of an authorized and qualified technician when they need to
be replaced. If it’s replaced make sure that its replacement is always the same type and value, as indicated.
The device is equipped with a Lithium-Ion Battery, which cannot be reached from the outside. Only refer to GIMA technical service
personnel to replace it. 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.
ONLY USE BATTERIES RECOMMENDED BY GIMA. USE OF BATTERIES OTHER THAN THOSE RECOMMENDED
WILL MAKE THE WARRANTY VOID AND NULL.
ONLY QUALIFIED PERSONNEL ARE AUTHORISED TO REPLACE THE INTERNAL BATTERY. ANY OPERATION
PERFORMED BY NON-TRAINED PERSONNEL MAY CAUSE DANGER (E.G. EXCESSIVE TEMPERATURE)
Fault type
Cause
Solution
1. Fixed Red Back-Light
Low battery
If it is intended to be used in ambulances, position the
device on the support bracket and leave the battery charge
until the Fixed White Back-Light gives the signal (TAB. I).
2. No LED is On and the Back-
Light failed to switch on
Locking device
Internal technical problem. Contact technical assistance.
3. No aspiration
Jar Cap badly screwed down
Unscrewed the cap, then rescrew it correctly
4. No aspiration
Lid seal not in its seat
Unscrew the cap and insert the seal properly in its seat
5. The float doesn’t close
If the cap has been washed,
ensure that the float is not
partially detached
Insert the float into it’s place
6. The float doesn’t close
The float it’s covered by dirty
material
Unscrewed the cap, leave the and put in on autoclave
7. Low suction
Foam inside the jar
Fill the jar to 1/3 full of ordinary water
8. No aspiration due to flow
leakage of mucus
Filter blocked
Replace filter
9. The Vacuum power on the
patient side is either very low
or absent
Protection filter blocked or
damaged
Connection tubes blocked,
kinked or disconnected
Shut-off valve blocked or
damaged
Pump motor damaged
Replace the filter
Replace or reconnect the tubes, check the jar
connections
Empty the jar, or disconnect the tube from the jar and
unblock the shut-off valve. The unit twill only work in
the upright position
Contact the technical service
10.Noisy
Technical internal problem
Contcat the technical service
Faults 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 –
9 - 10
None of the remedies has
achieved the desired results
Contact the seller or GIMA After-sales Assistance
Service
Lithium-Ion Battery Charging Cycles: The Lithium-Ion battery contained inside the device is guaranteed for a number greater
than 300 charging cycles. In the vicinity of 300 charging cycles you can ask for verification of operating status to the manufacturer
or to require replacement of the battery pack in such a way that you always have the component in perfect condition.
GB
22
If the overfill security system it’s activated, don’t proceede with the liquid aspiration. If the overfill security system doesn’t work
there are two cases:
1° case –If the overfill security system doesn’t work the aspiration will be stopped by the bacteriological filter who avoid the liquid
penetration inside the device.
2° case –If both the security system doesn’t work, there is the possibility that liquid comes inside the device, in this case return the
device to GIMA technical service.
GIMA S.p.A. will provide upon request electric diagrams, components list, descriptions, setting instructions and any other information
that can help the technical assistance staff for product repair.
BEFORE EVERY CHECKING OPERATION, IN CASE OF ANOMALIES OR BAD FUNCTIONING, PLEASE CONTACT
GIMA TECHNICAL SERVICE. GIMA DOES NOT GIVE GUARANTEE IF INSTRUMENT, AFTER THE TECHNICAL
SERVICE CHECKING, APPEARS TO BE TAMPERED.
INSTRUCTION FOR USE
The device must be checked before each use in order to detect malfunctions and / or damage caused by transport and / or
storage.
The working position must be such as to allow one to reach the control panel and to have a good view of the LCD screen, 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.
Operation using with AC/DC switching adapter
Connect the short silicon tube,with antibacterial filter, to the suction connector (VACUUM). The other tube, with one end
connected to the antibacterial filter with the other end to jar’s lid connector where has been fixed the red float. When the
90% of the volume of the jar is reached there is the activation of the security float (the float close the aspiration connector on
the jar) to the avoid liquid penetration inside the device.
Connect the long silicon tube to the other jar's lid connector (PATIENT PORT);
Connect the switching adapter to the device with the appropriate connector and insert the power cable plug to the power
socket. To start the treatment press the ON/OFF button and check its green back-light. When the device is switched on the
LCD screen activates displaying a bar-graph, graduated scale, and negative pressure value, which must be set by the operator;
The negative pressure is set with keys - and +, which are found below the LCD screen: Press one of the two keys with the
motor on. The level of the negative pressure will flash at the centre of the display.
Release the key and, after 3 seconds, the value will be operating (fixed digit on the display) and saved. The desired value
remains fixed until the operator varies the negative pressure, whilst the bar-graph moves along the semi-circumference
stopping in correspondence (graph) of the value set.
The maximum negative pressure value that can be set is: -75kPa (-0.75 bar)
The minimum negative pressure value that can be set is: -10kPa (-0.10 bar)
To suspend and / or terminate the treatment press the ON / OFF button and and pull the plug out from the power socket.
Unscrew the jar's lid and fill the jar 1/3 full or ordinary water (this for an easy cleaning operations and an rapid reaching of
the functionally vacuum) then rescrew the lid on the jar correctly.
To extract the accessories and start with cleaning.
The battery is fully charged in about 70 minutes with continuous operation.
WARNING: Before using the device, check the battery power status. Before each use proceed with charging the
battery. To maintain the device in good conditions, recharge the battery every 3 months (when not in use).
WARNING: Ensure that the FLUID SIDE or IN marker on the filter is on the side facing the collection jar lid and fitted into the
“VACUUM”. A wrong connection causes immediate destruction in case of contact with sucked liquids.
WARNING: The power supply cable plug is the element of separation from the electrical mains system: even if the units equipped
with a special on / off switch button, the power supply plug must be kept accessible once the device is in use so as to allow a
further method of disconnection from the mains supply system.
GB
23
Filter assembling
FLOW DIRECTION
Suction Pump
Inlet
Jar Air Tube
The device features an energy saving function which allows the device to increase its autonomy and decrease the number of revs of
the motor. In order to do so, it controls the negative pressure which is generated only when the operator suctions body fluids.
If the operator does not carry out the suction process the device lowers the number of revs of the motor, thus protecting the
duration of the internal battery.
NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER
Operation using cigarette lighter DC 12V
Connect the device’s external plug 12V to the ligther plug with the cigarette lighter cable. Check the battery power status of
the vehicle before the cigarette lighter cable. Press the switch to start suction
Press the switch to the I position to turn it on.
WARNING: Only use the originally supplied or recommended replacement cigarette ligther cables (view the chapter
“Important Safety Rules”)
WARNING: Before using the device, check the battery power status. Before each use proceed with charging the
battery. To maintain the device in good conditions, recharge the battery every 3 months (when not in use).
IN / Fluid Inside
IN
switch
“Proximity”
switch
ON / OFF
Adjustment
button
depression
“+”
sensor “Proximity”
LCD display
Adjustment
button
depression
“-“
GB
24
Recharging operations: to be able to charge the internal battery it is necessary to connect the universal switching adapter
(mod. UE 60140429SPA1 of FUHUA) to the electric network for approx. 360 minutes with the main switch to position 0.
The battery’s autonomy when fully charged is approx. 70 minutes with continued operations.
LIGHT INDICATORS:
The device is provided with a light indicator (directly on the LCD screen) which allows you to view the operation of the device,
autonomy of the battery, and the charge phase in progress.
The light indications, which appear during operation, are indicated in table I.
The charge cycle starts automatically it is necessary to connect the universal switching adapter (mod. UE 60140429SPA1 of
FUHUA) to the electric network. The charge occurs only when the motor of the suction unit is off.
DISPLAY IN CHARGE: this is on with white back-light and it remains on for the entire time. It switches off if there is no external
voltage. The charge phase lasts until the device is powered and the battery is kept at its maximum charge.
The large digits display “CHA” .
TAB. I –INDICATOR LIGHTS DURING OPERATIONS
Back-light signals
Phase
Problem / Cause
Solution
Fixed white back-light and
progressive activation of the
bar-graph
During the Charge
phase
Battery charge in progress
Wait
Fixed white back-light and
fixed activation of the bar-
graph
During the Charge
phase
Charging cycle complete
Remove the power supply
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 cycle upon
activation of the red back-light
Fixed red back-light
During battery
operation
Low battery
Start charge phase
ATTENTION: A long and
continuous beep is produced
during this signal to warn the
operator about the low charge
level of the battery.
Flashing red back-light
Automatic switch-off of
the device due to
discharged battery
Battery fully discharged
The flashing back-light switches
on upon reactivation of the
device. Immediately start the
battery charge cycle.
TAB. II –WRITTEN SIGNALS / BUTTON LED SIGNAL
Button LED signal / written
signal
Function
Colour
Position
ON/OFF button
Power on
Green
Near the front panel key
Proximity Button
Switch the ON/OFF key
Blue
LED located above the
“Proximity” key
CHA
Displays the battery charge
status
Fixed white back-light
and progressive
activation of the bar-
graph
Central in digits of large
dimensions
Small three-digit number
(000)
Displays the voltage of the
device if in charge phase or it
displays the full scale of the
bar-graph.
Fixed white or green
back-light depending on
whether external power
supply or battery and
progressive activation of
the bar-graph are used.
Sideways in small digits
Bar-graph (arc bar-graph)
It displays the trend of the
negative pressure or of the
charge status
Progressive activation of
the bar-graph (black)
Arc-shaped in the middle of the
screen
Large three-digit number
(000)
It displays the negative
pressure set by keys "up"
and "dw"
Fixed white or green
back-light depending on
whether external power
supply or battery is used.
Central in digits of large
dimensions
GB
25
PROXIMITY FUNCTIONS:
Pressing the "Proximity" (Lights BLUE LED) is activated on / off the motor by an infrared proximity sensor that detects the
presence of the operator's hand from a few inches away. This allows the operator to use the device without touching or focus
on pressing the button.
The on / off button is also active with the function of proximity inserted and can be used as an alternative.
To remove the "Proximity" you have to re-press the button.
The "Proximity" is retained, or if it was active before power off, then on again to return to this, but if it was not active will remain
disabled. The function set to power down the card after 20 minutes after turning off the engine if it is not then on again.
The unwanted approach of the hand to the Proximity sensors causes the device to switch off. To reactivate the
function, place the hand close to the sensors.
NOTE: It is up to the end user to activate or deactivate the Proximity sensor. With 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.
The SUPERVEGA EVO BATTERY ASPIRATOR surgical aspirator is an electro-medical device that requires particular precautions
regarding electro-magnetic compatibility and which must be installed and commissioned according to the electro-magnetic
compatibility information supplied. Portable and mobile radio communication devices (mobile phones, transceivers, etc.) may
interfere with the medical device and should not be used in close proximity with, adjacent to or on top of the medical device. If
such use is necessary and unavoidable, special precautions should be taken so that the electro-medical device functions properly
in its intended operating configuration (for example, constantly and visually checking for the absence of anomalies or
malfunctions).
The use of accessories, transducers and cables different to those specified, with the exception of transducers and cables sold by the
appliance and system manufacturer as spare parts, can lead to an increase in emissions or in a decrease of the immunity of the
device or system. The following tables supply information regarding the EMC (Electromagnetic Compatibility) characteristics of
the electro-medical device.
Guidance and manufacturer’s declaration – electromagnetic Emissions
The surgical SUPERVEGA EVO BATTERY ASPIRATOR is intended for use in the electromagnetic environment specifiedbelow.
The customers or the user of the surgical SUPERVEGA EVO BATTERY ASPIRATOR should assure that it’s used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
Irradiated / Conducted emissions
CISPR11
Group 1
The surgical SUPERVEGA EVO BATTERY ASPIRATOR only
used RF energy only for its internal functioning. Therefore,
its RF emissions are very low and are not cause
interference in proximity of any Electronic appliances.
Irradiated /Conducted emissions CISPR11
Class [B]
The surgical SUPERVEGA EVO BATTERY ASPIRATOR can be
used in all environments, including domestic and those
connected directly to the public mains distribution that
supplies power to environments used for domestic scopes.
Harmonic emissions EN 61000-3-2
Class [A]
Voltage fluctuations / flicker emissions
EN 61000-3-3
Complies
Guidance and manufacturer’s declaration – Immunity Emissions
The surgical SUPERVEGA EVO BATTERY ASPIRATOR is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical SUPERVEGA EVO BATTERY ASPIRATOR should assure that it’s used in such an environment.
Immunity Test
Level indicated by the
EN 60601-1-2
Compliance Level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
EN 61000-4-2
± 6kV on contact
± 8kV in air
The device doesn’t
change its state
Floors should be wood, conceret or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
transient / burst
EN 61000-4-4
± 2kV power supply
lines
± 1kV for input /
output lines
The device doesn’t
change its state
Mains power quality should be that of a typical
commercial environment or hospital.
Surge
EN 61000-4-5
± 1kV differential mode
The device doesn’t
change its state
Mains power quality should be that of a typical
commercial environment or hospital.
Loss of voltage, brief
voltage interruptions
and variations
EN 61000-4-11
5%UT(>95% dip UT)
for 0.5 cycle
40%UT(>60% dip UT)
for 5 cycle
70%UT(>30% dip UT)
for 25 cycle
<5%UT(>95% dip UT)
for 5 sec
-
Mains power quality should be that of a typical
commercial environment or hospital If the user of
the surgical SUPERVEGA EVO BATTERY
ASPIRATOR request that the appliance operates
continuously, the use of a continuity unit is
recommended.
Magnetic field
EN 61000-4-8
3A/m
The device doesn’t
change its state
The power frequency magnetic field should be
measured in the intended installation location to
assure that it’s sufficiently low.
Nota UTis the value of the power supply voltage
GB
26
Guidance and manufacturer’s declaration – Immunity Emissions
The surgical SUPERVEGA EVO BATTERY ASPIRATOR is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical SUPERVEGA EVO BATTERY ASPIRATOR should assure that it’s used in such an environment.
Immunity Test
Level indicated by
the
EN 60601-1-2
Compliance
Level
Electromagnetic environment - guidance
Conducted Immunity
EN 61000-4-6
3Vrms 150kHz to
80Mhz
(for non life-supporting
devices)
V1= 3 V rms
The portable and mobile RF communication devices,
including cables, must not be used closer to the
SUPERVEGA EVO device, than the separation distance
calculated by the equation applicable to the transmitter
frequency. Recommended separation distance
d = [3.5 / V1]
P
d = [12 / E1]
P
from 80 MHz to 800MHz
d = [23 / E1]
P
from 800 MHz to 2.5 GHz
Where P is the maximum nominal output voltage of the
transmitter in Watt (W) depending on the manufacturer of
the transmitter and the recommended separation distance
in metres (m). The intensity of the field from the fixed RF
transmitters, as determined by an electro-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
following symbol:
Radiated Immunity
EN 61000-4-3
3V/m 80MHz to
2.5GHz
(for non life-supporting
devices)
E1= 3 V / m
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 propagation is influenced by the
absorption and by reflection from buildings, objects and people.
a) The field intensity for fixed transmitters such as the base stations for radiotelephones (mobile and cordless) and terrestrial
mobile radio, amateur radio devices, radio AM and FM transmitters and TV transmitters can not be theoretically and
accurately foreseen. To establish an electro-magnetic environment generated by fixed RF transmitters, an electro-magnetic
study of the site should be considered. If the field intensity measured in the place where the device will be used surpasses the
above mentioned applicable level of conformity, the normal functioning of the device should be monitored. If abnormal
performance arises, additional measures such as changing the device's direction or positioning may be necessary.
b) The field intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V/m.
Recommended separation distance between portable and mobile radio-communication devices and the monitor
The SUPERVEGA EVO surgical aspirator is intended to operate in an electro-magnetic environment where RF irradiated
interferences are under control. The client or operator of the SUPERVEGA EVO device can help prevent electro-magnetic
interference by keeping a minimum distance between the portable and mobile RF communication devices (transmitters) and
the SUPERVEGA EVO device, as recommended below, in relation to the radio-communication maximum output power.
Maximum nominal
output power of the
Transmitter W
Separation distance from the frequency transmitter (m)
150 kHz to 80 MHz
d = [3.5 / V1]
P
80 MHz to 800 MHz
d = [12/E1]
P
800 MHz to 2.5 GHz
d = [23/E1]
P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
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
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the
absorption and by the reflection from buildings, objects and people.
GB
27
WARRANTY CONDITIONS
This product is guaranteed for a period of 24 months from the date of purchase. The warranty includes the repair or replacement
of defect spare parts free of charge, if the defect has been clearly described by the customer and determined by technical service.
Inspections on the part of the seller, performed at the request of the customer and intended to determined wjether the device is
fully functional, are not covered by the free-of-charge warranty service. This service will be charged to the customer depending on
the effort required. The consumables components are not subject to warranty. Consumable components are silicon tubes, filters,
seals, conical adaptor and suction catheter. Also exluded from warranty is all damage resulting from improper handling, wilful
damage or improper care of the device.
The warranty shall expire if repairs and servicing are not carried out by technical service.
RULES FOR RETURNING AND RAPAIRING
UNDER NEW EUROPEAN RULES,GIMA REQUIRES THE FOLLOWING PROCEDURES TO BE CARRIED OUT TO PROTECT THE
INSTRUMENT AND THE SAFETY OF ALL WHO COME IN CONTACT WITH IT.
Before returning an instrument for repair, the external surfaces and all accessories MUST be carefully disinfected with a cloth
soaked in methylated spirits or hypochlorite-based solution. The instrument and accessories should then be placed in a bag with a
note outlining the disinfection undertaken.
Failure to follow this procedure will result in the instrument being returned to the purchaser unrepaired.
Instruments returned for repair MUST be accompanied by a description of the problem. GIMA will not be responsible for damage
caused through improper use. To avoid such damage, please read the instruction carefully.
Where GIMA determines that an instrument is faulty, a replacement will be provided only if a SALES RECEIPT and STAMPED
GUARANTEE are provided. GIMA will not be responsible for damage accessories. These may be replaced at the customer’s expence.
Table of contents
Other Gima Medical Equipment manuals
