PROFESSIONAL MEDICAL PRODUCTS
ASPIRATORE SUPERVEGA EVO
SUPERVEGA EVO
SUCTION UNIT
ASPIRATEUR SUPERVEGA EVO
ABSAUGER SUPERVEGA EVO
ASPIRADOR SUPERVEGA EVO
M28182-M-Rev.2-12.20
28182
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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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 overow valve.
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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 qualied personnel (surgeon / professional nurse / assistant)
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 efciency and safety of the device.
- Always use the medical device with the antibacterial lter supplied by the manufacturer Gima in order to
ensure maximum efciency 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 device to the support bracket. Do not
try to operate the device before it has undergone a thorough check by qualied 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;
- Store and use the device in weatherproof environments and away from any heat sources
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 manufacturer 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-
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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 mechanical 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 stand-
ard.
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.
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 SUPERVEGA EVO 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 EVO SUCTION UNIT is not suitable for MRI. Do not introduce the device in MRI environ-
ments
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 5,2 A - 14,8 V by internal Li-Ion battery
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 190 x 150mm
Battery Holding Time 70 minuti
Battery Time Charge 360 minutes
Battery life 300 charging cycles
Working Condition Room temperature: 0 ÷ 40°C
4A - 12V 4A) by ambulance adapter model
Room humidity percentage: 0 ÷ 85% RH
Atmospheric pressure: 800 ÷ 1060 hPa
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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
The technical specications 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 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 8x14 mm
• Hydrophobic and antibacterial lter
• A support bracket
• Suction probe CH20
• AC/DC adapter
• Power supply cord for AC/DC adapter
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 whenever 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 assessment 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
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.
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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.
WARNING: Suction tubes for insertion in the human body purchased separately from the machine
should comply with ISO 10993-1 standards on material biocompatibility.
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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 (overow 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 overow 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 leackages 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 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 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.
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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.
Internally, the device (see electrical sheet) is protected by two fuses F1 and F2 (F 15A L 125V), which cannot
be reached from the outside; refer to technical personnel authorised by the manufacturer to replace them.
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.
Only use batteries recommended by Gima. Use of batteries other than those recommended
will make the warranty void and null.
Only qualied personnel are authorised to replace the internal battery. Any operation Performed by
non-trained personnel may cause danger (e.g. Excessive temperature)
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.
Typical defect Cause Remedy
1. Steady Red Back-Light Low battery Should it be used on an ambulance, place the
2. No Led On and Back-Light
failure
3. No aspiration Vessel lid screwed incorrectly Unscrew and tighten the lid of the vessel
4. No aspiration Cover gasket not in place Unscrew the cover and reposition the gasket in
5. Blocked oat Fouling on the oat Unscrew the cover, remove the oat and pro-
6. Failure to close the oat If the cap has been washed, check that
7. Slow aspiration Foam formation inside the collecting
8. No aspiration caused by
mucus leakage
9. Low and/or no vacuum
power
10. Noisy device Internal problem Contact the Gima technical service
Defects 1 - 2 - 3 - 4 - 5 - 6 - 7
- 8 - 9 - 10
Device locked Internal technical problem. Contact technical
the oat is not partially detached
vessel
Clogged lter Replace the lter
• Unsuitable aspiration level
• Protection lter blocked
• Connection pipes to the lter and the
device blocked, kinked or discon-
nected
• Overow valve closed or blocked
• Damaged pump
None of the remedies was effective Contact your Gima dealer or service centre
device on the support bracket and leave it to
charge until a Steady White Back-Light is shown
(ref. TAB.I).
If equipped with an AC/DC power supply, connect the power cable to the mains, with the
switch not pressed and leave it to charge until
a Steady White Back-Light is shown (ref. TAB.I)
assistance.
its cover housing.
ceed with cleaning.
Wedge oat
Fill the vessel 1/3 full of normal water
• Proceed to set the correct aspiration value
• Filter replacement
• Connect the pipes to the lter and/or vessel or
replace them if clogged
• Unblock the overow valve, hold the device
upright
• Contact the Gima technical 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 verication
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.
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If the overll security system it’s activated, don’t proceede with the liquid aspiration. If the overll security
system doesn’t work there are two cases:
1° case – If the overll security system doesn’t work the aspiration will be stopped by the bacteriological lter
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.
The medical device contains rmware. This information is made available in order to assist the technical assistance personnel in the eventual repair of the appliance.
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.
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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 lter.
WARNING: For proper use, place the aspirator on a at, stable surface in order to have the full volume
of use of the jar and better efciency of the overow device.
Operation with Internal Battery
• Connect the short silicon tube, with antibacterial lter, to the suction connector (VACUUM). The other tube,
with one end connected to the antibacterial lter with the other end to jar’s lid connector where has been
xed the red oat. When the 90% of the volume of the jar is reached there is the activation of the security
oat (the oat close the aspiration connector on the jar) to the avoid liquid penetration inside the device.
Filter assembling
Make sure the lter is assembled with the arrows on the side of the patient.
WARNING: The inside of the medical device must be regularly checked for the presence of liquids or other
visible contamination (secretions). In the presence of liquids or other visible contamination, immediately replace the medical device due to the risk of an insufcient vacuum ow rate.
These products have been designed, tested and manufactured exclusively for single patient use and for a
period no longer than 24 hours.
• Connect the long silicon tube to the other jar’s lid connector (PATIENT PORT);
• 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;
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• 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 ash at the centre of the display.
Release the key and, after 3 seconds, the value will be operating (xed digit on the display) and saved. The
desired value remains xed 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: -15kPa (-0.15 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 ll 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.
• At the end of each use place the device on its FIXING BRACKET (ref. SECURING THE NEW SUCTION
UNIT)
• 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: The seal hook placed on the SUPPORT is the dividing element from the 12V mains, even
if the device is equipped with the specic ON/OFF button.
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 uids.
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.
“Proximity” sensor
“Proximity” switch
LCD display
Adjustment button
depression “-”
ON/OFF switch
Adjustment button
depression “+”
Charging operations (through the supplied AC/DC adapter): The internal battery can also be recharged
with the universal power supply by connecting it through the special connector and inserting the power cable
plug into the power socket. Estimated charging time about 6 hours (360 minutes) with the device turned off
(not operating).
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The symbol positioned near the 12V jack on the casing requires the user to read the instructions before
each use, identifying the model and type of power supply which can be connected through the information
provided in the instructions for use.
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 by placing the device on the specic support bracket (ref. Support
Bracket and Charge Chapter). 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 activa-
tion of the bar-graph
Fixed white back-light
and xed activation of
the bargraph
Fixed white back-light
and xed activation of
the bar-graph
Fixed green back-light During battery
Fixed yellow back-light During battery
Fixed red back-light During battery
Flashing red back-light Automatic switch-off
During the Charge
phase
During the Charge
phase
During the Charge
phase
operation
operation
operation
of the device due to
discharged battery
Battery charge in
progress
Charging cycle complete Remove the device from the
Charging cycle complete
(with AC/DC power
supplì)
Primary status / Battery
fully charged
Intermediate status /
Battery not fully charged
Low battery Start charge phase
Battery fully discharged The ashing back-light switches on upon
Wait
support plate of the ambulance
Remove the power supply
Battery operation guaranteed
Battery operation guaranteed / start the charge
cycle upon activation of the red back-light
ATTENTION: A long and continuous beep is
produced during this signal to warn the opera-
tor about the low charge level of the battery.
reactivation of the device. Immediately start
the battery charge cycle.
TAB. II – WRITTEN SIGNALS / BUTTON LED SIGNAL
Button LED signal /
written signal
ON/OFF button Power on Green Near the front panel key
Proximity Button Switch the ON/OFF key Blue LED located above
CHA Displays the battery
Small three-digit
number (000)
Bar-graph
(arc bar-graph)
Function Colour Position
the “Proximity” key
charge status
Displays the voltage of the
device if in charge phase
or it displays the full scale
of the bar-graph.
It displays the trend of the
negative pressure or of the
charge status
Fixed white back-light and progressive activation of the bargraph
Fixed white or green back-light
depending on whether external
power supply or battery and
progressive activation of the
bar-graph are used.
Progressive activation of the
bar-graph (black)
Central in digits of large
dimensions
Sideways in small digits
Arc-shaped in the middle
of the screen
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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
NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER
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.
SUPPORT BRACKET AND CHARGE
The device is supplied with support bracket, therefore, the SUPERVEGA EVO suction unit can be xed to
the rescue means, in compliance with the standards of reference. This bracket is equipped with electrical
cable connected to the 12V
the suction unit to be charged.
• The bracket must be installed in compliance with the indications provided in this manual. Failure to comply
with such warning may compromise the conformity to standard EN 1789 (design and construction of med-
ical vehicles) and signicantly reduce the safety of the medical device;
• Never alter mechanical, electrical, and structural parts of the bracket. These interventions make the device
dangerous and, therefore, they preclude its use;
power supply source of the ambulance and allows the internal battery of
The support bracket of the SUPERVEGA EVO device consists of a plastic part (ABS) and a seal hook, which
allows the suction unit to be xed safely and easily. The gure below shows the bracket complete in all its
parts.
MicroSwitch
Contact n
Contact n
Seal hook
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The electrical cable of the bracket has double insulation and it must always be connected to an electrical
source (12 V ) of the ambulance. Connection to the power supply source must always comply with the
polarity.
In case of incorrect connection, the internal battery cannot be charged.
The electrical connections must always be performed by qualied and authorised personnel. Connections must never be entrusted to unauthorised personnel.
Even if voltage is only 12V , short circuit may cause serious damage to persons and objects (risk of
re, etc.).
Securing the Supervega Evo suction unit
The support bracket has been designed and manufactured only to x and charge the SUPERVEGA EVO
suction unit; no other device can be secured to this system.
The seal efciency and charge of the device is guaranteed only for this surgical suction unit model.
Insertion and extraction operations of the suction unit:
• Take the SUPERVEGA EVO suction unit;
• Place the device on the support bracket pulling the seal hook. Try to t it inside the section on the bottom
of the device;
• Before removing your hands from the suction device, make sure that it is xed correctly (pull the handle of
the device upwards and check the correct position of the device on the bracket);
• To remove the suction unit from the bracket, pull the seal hook and remove the suction unit from the section
on the bottom of the device. Firmly hold the device and remove it from the bracket placing it in a safe point.
Device bottom
Seal hook
Support
bracket
Once the suction unit has been tted in the support bracket, make sure that the charge is in progress
by checking the signal of the LCD screen on the front of the device as indicated in TAB. I and TAB. II.
The charge time of the internal battery (fully discharged) with support bracket must last about 6 hours (360
minutes) with the device switched off (not running). Always charge the battery after each use. The continuous
charge of the battery does not damage the internal battery but allows maximum autonomy.
Support bracket functional test
All test described here allow the user to check the efciency of support, proper charging of the vacuum cleaner and / or the need for intervention by the service technician. This check must be performed at least once a
day, and always weekly.
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• Check the operation of the bracket (without suction unit) by repeatedly acting on the seal hook. The move-
ment must be free from obstructions.
• Always make sure that the xing screws are tightened correctly;
• Fit the suction unit in the bracket as indicated in Chapter “Securing the SUPERVEGA EVO suction device”;
• Visually check (as per TAB II) the activation of the LCD screen.
In the event one or more phases fail, refer to the technical service.
Do not tamper with mechanical and/or electrical parts as this may affect the safety and efciency of the
device.
No electrical and/or mechanical part of the support bracket has been designed to be repaired by the manufacturer, customer, and/or user. Always refer to the authorised technical service.
Maintenance and reuse
Once the device has been tted in the bracket, always make sure that, upon activation, the LCD screen conrms the charge in progress of the internal battery (rif. TAB.I and TAB.II).
When using emergency vehicles, always check the housing of the suction unit in the support bracket at the
end of the intervention.
In case of accidents or collisions of the emergency vehicle, always request the authorised technical service
to check the support bracket and the suction unit.
RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
This section contains information regarding the conformity of the compliance with the EN 60601-1-2 Standard
(2015).
The SUPERVEGA EVO SUCTION UNIT 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 conguration (for example, constantly and visually checking for the absence of anomalies or malfunctions). The use of accessories, transducers and cables differing from those specied, 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 SUPERVEGA EVO SUCTION UNIT is intended for use in the electromagnetic environment specied below. The
customers or the user of the SUPERVEGA EVO SUCTION UNIT should make sure that it’s used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
Irradiated / Conducted
emissions CISPR11
Irradiated / Conducted
emissions CISPR11
Harmonic emissions
EN 61000-3-2
Voltage uctuations / icker
emissions EN 61000-3-3
Group 1 The SUPERVEGA EVO SUCTION UNIT only used RF energy only
Class [B] The SUPERVEGA EVO SUCTION UNIT can be used in all environ-
Class [A]
Complies
for its internal functioning. Therefore, its RF emissions are very low
and are not cause interference in proximity of any Electronic appliances.
ments, including domestic and those connected directly to the public
mains distribution that supplies power to environments used for do-
mestic scopes.
ENGLISH
Guidance and manufacturer’s declaration – Immunity Emissions
The SUPERVEGA EVO SUCTION UNIT is intended for use in the electromagnetic environment specied below. The
customers or the user of the SUPERVEGA EVO SUCTION UNIT should make sure that it’s used in such an environment.
Immunity Test Level indicated by the
Compliance Level Electromagnetic environment - guidance
EN 60601-1-2
Electrostatic
discharge (ESD)
EN 61000-4-2
+/-8kV on contact
+/-15kV in air
The device doesn’t
change its state
Floors should be wood, concrete or ceramic
tile. If oors 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 /
The device doesn’t
change its state
Mains power quality should be that of a typical
commercial environment or hospital.
output lines
Surge
EN 61000-4-5
Loss of voltage, brief
voltage interruptions
and variations
EN 61000-4-11
± 1kV differential mode
+/-2 kV ordinary mode
<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
The device doesn’t
change its state
Mains power quality should be that of a typical
commercial environment or hospital.
- - Mains power quality should be that of a typi-
cal commercial environment or hospital If the
user of the SUPERVEGA EVO SUCTION
UNIT request that the appliance operates
continuously, the use of a continuity unit is
recommended.
<5% UT (>95% dip UT)
for 5 sec
Magnetic eld with
network frequency
(50/60 HZ)
30A/m The device doesn’t
change its state
The power frequency magnetic eld should
be measured in the intended installation location to make sure that it’s sufciently low.
EN 61000-4-8
Note UT is the value of the power supply voltage
28
Guidance and manufacturer’s declaration – Immunity Emissions
The SUPERVEGA EVO SUCTION UNIT is intended for use in the electromagnetic environment specied below.
The customers or the user of the SUPERVEGA EVO SUCTION UNIT should make sure that it’s used in such an envi-
ronment.
Immunity Test Level indicated by the
EN 60601-1-2
Conducted
Immunity
EN 61000-4-6
3Vrms 150kHz
to 80Mhz
(for non life-supporting
devices)
Compliance
Level
V1 = 3 V rms
Electromagnetic environment - guidance
The portable and mobile RF communication devices,
including cables, must not be used closer to the SUPERVEGA EVO SUCTION UNIT device, than the sep-
aration distance calculated by the equation applicable
to the transmitter frequency.
Recommended separation distance
3,5
Radiated
Immunity
EN 61000-4-3
10V/m 80MHz
to 2.7GHz
(for non life-supporting
devices)
E1 = 10 V / m
d=
d=
d=
V
12
E
23
E
√P
1
from 80 MHz to 800MHz
√P
1
1
from 800 MHz to 2.7 GHz
√P
29
ENGLISH
Where P is the maximum nominal output voltage of the
transmitter in Watt (W) depending on the manufactur-
er of the transmitter and the recommended separation
distance in metres (m). The intensity of the eld from
the xed RF transmitters, as determined by an elec-
tro-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 identied by the following symbol:
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 inuenced by the
absorption and by reection from buildings, objects and people.
a) The eld intensity for xed 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 xed RF transmitters, an electro-magnetic study of the site should be considered. If the eld 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 eld intensity on an interval frequency of 150 kHz to 80 MHz should be less than 10 V/m.
Recommended separation distance between portable and mobile radio-communication devices and the monitor
The SUPERVEGA EVO SUCTION UNIT 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 SUCTION UNIT
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 SUCTION UNIT 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)
150KHz to 80MHz 80MHz to 800MHz 800MHz to 2,7GHz
d=
3,5
V
√P
1
d=
12
√P
1
E
d=
23
E
√P
1
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 inuenced by the
absorption and by the reection from buildings, objects and people
SYMBOLS
ENGLISH
30
Caution: read instructions (warnings) carefully
Keep in a cool, dry place Keep away from sunlight
Manufacturer Date of manufacture
Product code Lot number
Medical Device complies
with Directive 93/42/EEC
WEEE disposal Class II applied
Serial number Temperature limit
Battery Atmospheric Pressure limit
Direct current Humidity limit
IP22
Covering Protection rate ON / OFF
Disposal: The product must not be disposed of along with other domestic waste. The users must
dispose of this equipment by bringing it to a specic recycling point for electric and electronic equipment.
Follow instructions for use
Type BF applied part
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 Ofce, your household
waste disposal service or the shop where you purchased the product.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
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