PROFESSIONAL MEDICAL PRODUCTS
ASPIRATORE CHIRURGICO SUPER VEGA - 2 X 2 L
SU CARRELLO / SU CARRELLO CON PEDALE
SUPER VEGA SUCTION ASPIRATOR - 2 X 2 L
ON TROLLEY / ON TROLLEY WITH FOOTSWITCH
ASPIRATEUR SUPER VEGA - 2 X 2 L - SUR CHARIOT /
SUR CHARIOT AVEC INTERRUPTEUR À PÉDALE
CHIRURGISCHER ABSAUGER SUPER VEGA - 2 X 2 L
ROLLABSAUGGERÄT /ROLLABSAUGGERÄT
MIT FUSSSCHALTER
ASPIRADOR QUIRÚRGICO SUPER VEGA - 2 X 2 L
SOBRE CARRO / SOBRE CARRO CON PEDAL
M28191-M-Rev.2-09.20
28191 - 28192
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Italy
0476
ENGLISH
SUPER VEGA SUCTION ASPIRATOR it’s an electrical powered surgical aspirator (230V ~ / 50Hz) used for
the nasal, oral and tracheal suction in man of body liquids (mucus, catarrh or blood).
The equipment is equipped with a trolley provided with 5 wheels (three of them are provided with loocking
system in order to avoid the equipment can overbalance) and an external plastic enclosure. Thanks to this
characteristics and to the rating that it has, this product is particularly suitable for hospital use, minor surgical
applications and post-operative therapy at home. Made of highly heat resistant, electrically insulated plastic
material in conformity with the latest European safety standard, the product is supplied with 2 complete
polycarbonate autoclavable jars with overow valve and it is equipped with aspiration regulator and vacuum
indicator located on the front panel.
Device designed to provide easy transport and use CONTINUOUS. On request it is available the version with
pedal control and version with pedal control and collection ow diverter.
28191 SUPER VEGA SUCTION ASPIRATOR ON TROLLEY
28192 SUPER VEGA SUCTION ASPIRATOR ON TROLLEY WITH FOOTSWITCH
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GENERAL WARNING
Read instruction manual carefully before use.
Only highly qualied 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 inspected for visual
damage. Check the mains cable and do not connect to power if damage is apparent;
2. Before connecting the appliance always check that the electric data indicated on the data label and the type
of plug used, correspond to those of the mains electricity to witch it’s to be connected;
3. Respect the safety regulations indicated for electrical appliances and particularly:
- Use original components and accessories provided by the manufacturer to guarantee the highest efciency and safety of the device.
- The device can be used only with the bacteriological lter.
- Never immerge the appliance into water.
- Position the device on stable and at surfaces in a way that the air inlets on the back aren’t obstructed;
- To avoid incidents, do not place the aspirator on unstable surfaces, which may cause it to accidentally fall
and lead to a malfunction and/or breakage. Should there be signs of damage to the plastic parts, which
may expose inner parts of the energised device, do not connect the plug to the electrical socket. Do not
attempt to make the device work before it has been thoroughly checked by qualied personnel and/or the
GIMA technical service department.
- Don’t use in the presence of inammable substances such as anaesthetic, oxygen or nitrous oxide.
- Don’t touch the device with wet hands and always prevent the appliance coming into contact with liquids.
If you accidentally fell into the water, unplug the power cord from the power outlet before grasping the
appliance.
- 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 dened by the manufacturer.
The manufacturer will not be responsible for damage due to improper use or connection to an electrical
system not complying with current regulation.
6. The medical device requires special precautions regarding electromagnetic compatibility and must be in-
15
stalled and used in accordance with the information provided with the accompanying documents: the SUPER VEGA SUCTION ASPIRATOR 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) furnished with the relative CE compliance certication according to the requirements of regulation ISO
10993-1: thus, no allergic reactions and skin irritations may occur.
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.
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.
ENGLISH
CONTRAINDICATIONS
- Before using the ASPIRATOR, consult the instructions for use: failure to read all the instructions in this
manual can be harmful for the patient.
- The device cannot be used to drain chest uids.
- The device must not be used for suction of explosive, corrosive or easily ammable liquids.
- ASPIRATOR is not suitable for MRI. Do not introduce the device in MRI environments.
TECHNICAL CHARACTERISTICS
Model SUPER VEGA SUCTION ASPIRATOR
Typology (MDD 93/42/EEC) Medical Device Class IIa
Classication UNI EN ISO 10079-1 HIGH VACUUM / HIGH FLOW
Main Voltage 230 V ~ / 50 Hz
Power consuption 110 VA
Fuse F 1 x 1.6A L 250 V
Maximum suction aspiration (without jar) -80kPa (- 0.80bar)
Minimum suction aspiration (without jar) Less than -40kPa (-0.40 bar)
Maximum ow (without jar) 40 l/min
Weight 6.2 Kg
Dimension 380 x 920 (h) x 360mm
Functioning NON-STOP OPERATED
Accurancy of Vacuum Indicator ± 5%
Working condition Room temperature: 5 ÷ 35°C
Conservation and transport condition Room temperature: - 40 ÷70°C
Room humidity percentage: 30 ÷75% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Room humidity percentage: 10 ÷ 100% RH
Atmospheric pressure: 500 ÷ 1060 hPa
ENGLISH
16
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.
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 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
• N°2 COMPLETE ASPIRATION JAR 2000cc
• CONICAL FITTING
• SUCTION CATHETER CH20
• TUBES SET 8 mm x 14 mm
• ANTIBACTERIAL AND HYDROFOBIC FILTER
• FOOTSWITCH CONTROL (for versions equipped with footswitch control)
• EUROPEAN POWER SUPPLY CORD (H05VV-F - 2x0.75mm² - 2mt)
On request, are available versions with disposable collection system (FLOVAC® 2000ml) composed by a
reusable polycarbonate vessel and polyethylene disposable bag (collection liner for uids suction canisters).
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.
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.
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.
Service life of the device: More than 850 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.
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ENGLISH
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 (overow device, washer).
• Disconnect all tubes from the jar and the protection lter.
• Empty and dispose of the contents of the suction container (also observe regional regulations);
• 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
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.
Further disinfection of the jar and lid can be performed with commercial disinfectant by carefully following
the instructions and the dilution values supplied by the manufacturer. After cleaning, allow to air dry in a
clean environment. 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 sure 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).
Disposing of disposable bags:
If the device is tted with FLOVAC® disposable collection systems (consisting of a rigid, reusable polycarbonate 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 collection 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. The rigid, reusable
container and the reusable “Male” tting may be cleaned and disinfected using water and neutral detergents
and/or sterilised in an autoclave at 121°C (relative pressure 1 bar) for 15 min. Do not use solvents or alcohol
for cleaning and disinfection as these products may damage the component. The mechanical strength of the
FLOVAC reusable container and of the tting is guaranteed for up to 30 cleaning and sterilisation cycles at
the specied conditions (EN ISO 10079-1). Beyond this limit, the physical and mechanical properties of the
plastic may deteriorate and, therefore, replacement is recommended.
ENGLISH
18
PERIODICAL MAINTENANCE CHECKS
The SUPER VEGA SUCTION ASPIRATOR does not need maintenance or lubrication. It is, however, necessary 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 and feeding cable, they might have been damaged
during previous use. Connect the cable to electrical network and turn the switch on.
Close the aspirator outlet with your nger and with suction regulator at maximum check that the vacuum
indicators reaches at least -80kPa (-0.80 bar). Rotate the knob from right to left. The vacuum indicator should
go down -40kPa (-0.40 bar).
Check that no loud noises are present. A protection fuses (F 1 x 1.6 A L 250V) reachable from exterior and
situated in the plug protects the instrument. For fuses replacing, always the type and the range.
Before changing the fuse, disconnect the plug from the power supply socket.
Internally, the device (only for devices tted with a circuit board) is protected by a fuse (T 50mA L 250V) that
cannot be reached from the outside, so please contact a technician authorised by the manufacturer for its
replacement.
Fault type Cause Solution
1. The suction unit doesn’t
work
2. No aspiration Jar Cap not screwed on correctly Unscrew the cap, and re-screw it
3. No aspiration Lid seal not in its seat Unscrew the cap and insert the seal
4. The Vacuum power on
the patient side is either
very low or absent
5. The oat doesn’t close If the cap has been washed,
6. The oat doesn’t close The oat it’s covered by dirty
7. Low suction Foam inside the jar Fill the jar to 1/3 full of ordinary water
8. No aspiration due to
ow leakage of mucus
Faults 1 - 2 - 3 - 4 - 5 - 6
- 7 - 8
Cable is damaged External
power source failure
• Vacuum regulator set
to minimum
• Protection lter blocked or
damaged
• Connection tubes blocked,
kinked or disconnected
• Shut-off valve blocked or
damaged
• Pump motor damaged
ensure that the oat is not
partially detached
material
Filter blocked Replace lter
None of the procedures have
achieved the desired results
Replace the cable Check the external
power source
properly in its seat
• Turn the vacuum regulator clockwise
and check the value of the vacuum on
the gauge
• Replace the lter
• 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
• Refer to authorised service personnel
Fit the oat into it’s place
Unscrewed the cap, leave the and put
in on autoclave
Contact GIMA customer service
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.
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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.
ENGLISH
INSTRUCTION FOR USE
Assembly of the device SUPER VEGA SUCTION ASPIRATOR: Take the 5 arm base and set up the 5
wheels that come with the above device. The wheels provided with braking device must be placed one next to
the order. Take the support bar that comes with the device SUPER VEGA SUCTION ASPIRATOR and place
it in the hole on the 5-arm base. From under the base, lock the two parts by means of the supplied screw.
Eventually, place the device on the trolley.
• 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 empty indicator, the jar and the antibacterial lter.
• If the device is to be transported from one place to another, to prevent the liquid collection jar from falling
and consequently the liquid from spilling, removing the jar from the device is recommended.
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. The vacuum jar, during use, must be used in
vertical mode, to prevent the action of the backow valve. If this protection is triggered, turn the device off and
disconnect the pipe connected to the vacuum jar (indicated with the word VACUUM) on its cover.
• Connect one end of the short silicon tube, with antibacterial lter, to the suction connector on the lid of the
jar.
• The other tube, connected to the lter on one end, must be attached to the connector on the ask cover to
which the oat is secured inside. (overow device). The overow device starts working (the oat closes the
connector on the cover) when the maximum volume of liquid is reached, so no liquid can enter the machine
(90% of the ask’s total volume), thus ensuring that the liquid cannot penetrate inside the machine. The
device must be used on a at work top.
WARNING: Ensure that the FLUID SIDE or IN marker on the lter is on the side facing the collection jar
lid and tted into the “VACUUM”. A wrong connection causes immediate destruction in case of contact with
sucked liquids.
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.
ENGLISH
20
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 silicone tube to the “PATIENT” jar outlet
• Connect the other end of the long silicon tube to the probe plastic connector, then connect the suction
probe to it.
• Connect the power cord to the device then connect the plug to the electrical mains supply.
• Push switch on position ON/OFF to start suction.
• Unscrew the lid of the jar and ll the jar 1/3 full or ordinary water (this assists the unit to reach peak vacuum
performance and makes clean-up easier) then re-screw the lid on the jar correctly.
• During operation the jar has to be in vertical position to avoid overow valve to cut off aspiration. Should
this happen, switch off the device and disconnect the tube from the jar cover (from “VACUUM” outlet).
• Once nished push switch on ON/OFF position and unplug.
• Remove the accessories and clean.
• At the end of each use, place the device in its box away from dust.
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.
Autoclavable Silicon 8x14 mm
Vacuum (Kpa / Bar)
“PATIENT” Port
“VACUUM” Port
Antibacterial Filter
Vacuum Regulator Knob
ON / OFF Switch
Conical Fittings
Collection Jar in Autoclave PC
WARNING: NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER
KEEP OFF THE REACH OF CHILDREN OR NOT CAPABLE PEOPLE WITHOUT SUPERVISION
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ENGLISH
Footswitch control device:
The equipment, on request, is provided with a footswich control device. It allows the continuous
use of the surgical aspirator. In this case, the plug of the footswitch device shall be inserted into the appropriate socket outlet placed on the back side of the equipment.
Near the footswitch control plug, there is a commutator that operates
the device directly using the mains or by using the footswitch control.
When the switch is turned on (green light) and the commutator is in
position I, the device works directly using the mains.
When the switch is turned on (green light) and the commutator is in
position II, the device works via remote control (footswitch control).
When the switch is turned on (green light) and the commutator is in
position 0, the device is powered but not in operation.
Using the footswitch control and the ow deviator:
If using equipment tted with a ow deviator, users may direct suctioned liquids in any of the two collection
tanks provided. Flow deviator comes with two complete suction kits (2 sets of tubes, 2 antibacterial and hydrophobic lters and two conical junctions).
WARNING: NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER
Using FLOVAC® disposable collection system:
Before connecting the disposable collection system, remove the blue ring tted on the tank holder for a more
comfortable insertion of the same container.
- After opening the package, fully stretch the bag and then atten it concentrically to eliminate as much air
as possible.
- Insert the bag and apply the cover to an appropriately sized reusable rigid container by pressing rmly
around the entire perimeter. Make sure that the system is completely sealed.
- Close the connector marked as “TANDEM” with the lid provided.
- Connect the power source of the vacuum to the VACUUM port equipped with specic reusable conical
tting with “male” connection.
- Connect the patient tube to the PATIENT port of the cover.
- Before use, check all closures and make sure there are no leaks, starting the aspiration source. If the bag
expands to fully adhere to the walls of the rigid container and the cover bends towards the inside of the
glass, the system is not leaking.
- Start the aspiration and periodically check the lling level of the container. The overow valve will cause the
interruption of aspiration if the aspirated uids have reached the maximum lling level of the device.
- When the oat valve intervenes signalling the device is too full, the suction source must be disconnected
within no more than 5 minutes.
Warning: The accidental inversion of connections may cause contamination for the operator and/or
for the vacuum generation equipment.
RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
This section contains information regarding the conformity of the compliance with the EN 60601-1-2 (2015)
Standard. The SUPER VEGA SUCTION 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,
ENGLISH
22
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 different to 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 SUPER VEGA SUCTION ASPIRATOR is intended for use in the electromagnetic environment specied below. The
customers or the user of the SUPER VEGA SUCTION ASPIRATOR should assure 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
Guidance and manufacturer’s declaration – Immunity Emissions
The SUPER VEGA SUCTION ASPIRATOR is intended for use in the electromagnetic environment specied below. The
customers or the user of the SUPER VEGA SUCTION ASPIRATOR should assure that it’s used in such an environment.
Immunity Test Level indicated by the
Electrostatic
discharge (ESD)
EN 61000-4-2
Electrical fast
transient / burst
EN 61000-4-4
Surge
EN 61000-4-5
Loss of voltage, brief
voltage interruptions
and variations
EN 61000-4-11
Magnetic eld with
network frequency
(50/60 HZ)
EN 61000-4-8
Note UT is the value of the power supply voltage
EN 60601-1-2
+/-8kV on contact
+/-15kV in air
± 2kV power supply
lines
± 1kV for input /
output lines
± 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
<5 % UT (>95% dip UT)
for 5 sec
30A/m The device doesn’t
Group 1 The SUPER VEGA SUCTION ASPIRATOR only used RF energy only
Class [B] The SUPER VEGA SUCTION ASPIRATOR can be used in all en-
Class [A]
Complies
for its internal functioning. Therefore, its RF emissions are very low
and are not cause interference in proximity of any Electronic appli-
ances.
vironments, including domestic and those connected directly to the
public mains distribution that supplies power to environments used
for domestic scopes.
Compliance Level Electromagnetic environment - guidance
The device doesn’t
change its state
The device doesn’t
change its state
The device doesn’t
change its state
- - Mains power quality should be that of a typical
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%.
Mains power quality should be that of a typical
commercial environment or hospital.
Mains power quality should be that of a typical
commercial environment or hospital.
commercial environment or hospital If the user
of the SUPER VEGA SUCTION ASPIRATOR
request that the appliance operates continuously, the use of a continuity unit is recom-
mended.
The power frequency magnetic eld should be
measured in the intended installation location
to make sure that it’s sufciently low.
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ENGLISH
Guidance and manufacturer’s declaration – Immunity Emissions
The SUPER VEGA SUCTION ASPIRATOR is intended for use in the electromagnetic environment specied below. The
customers or the user of the SUPER VEGA SUCTION ASPIRATOR should assure that it’s used in such an environment.
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 SUPER
VEGA device, than the separation distance calculated
by the equation applicable to the transmitter frequency.
Recommended separation distance
3,5
√P
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
1
from 80 MHz to 800MHz
√P
1
1
from 800 MHz to 2.7 GHz
√P
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 eld from the
xed 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 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 terres-
trial 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 SUPER VEGA 36 surgical aspirator is intended to operate in an electro-magnetic environment where RF irradiated
interferences are under control. The client or operator of the SUPER VEGA 36 device can help prevent electro-magnetic
interference by keeping a minimum distance between the portable and mobile RF communication devices (transmitters)
and the SUPER VEGA 36 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
ENGLISH
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
Caution: read instructions (warnings)
carefully
Keep in a cool, dry place Keep away from sunlight
Manufacturer Date of manufacture
Product code Lot number
Follow instructions for use
24
Medical Device complies
with Directive 93/42/EEC
WEEE disposal Class II applied
Serial number Temperature limit
Fuse
ON / OFF Atmospheric pressure limit
0 / I / II
IPX1
The technical specications may change without notice
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Remote Control
Covering Protection rate
(for pedal of code 28192)
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.
Type B applied part
Alternating current
~
Mains frequency
Hz
Humidity limit
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