Gima SUPER VEGA 36 User manual

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
ASPIRATORE A BATTERIA SUPER VEGA 36
SUPER VEGA 36 BATTERY ASPIRATOR
ASPIRATEUR SUPER VEGA BATTERIE 36 L/MIN
CHIRURGISCHER ABSAUGER SUPER VEGA 36 - BATTERIE
ASPIRADOR QUIRÚRGICO SUPER VEGA 36 - BATERÌA
APARELHO DE SUCÇÃO CIRÚRGICO SUPER VEGA 36
A BATTERIA
M28190-M-Rev.3-12.19
PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in Italy
ATTENZIONE: Gli operatori devono leggere e capire
completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
AVIS: Les opérateurs doivent lire et bien comprendre
ce manuel avant d’utiliser le produit.
ACHTUNG: Die Bediener müssen vorher dieses Handbuch
gelesen und verstanden haben, bevor sie das Produkt benutzen.
ATENCIÓN: Los operadores tienen que leer y entender
completamente este manual antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender
completamente este manual antes de usar o produto
Manuale d’uso - User manual
Manuel de l’utilisateur - Gebrauchsanweisung
Guía de Uso - Guia para utilização
28190 0476

15 ENGLISH
SUPER VEGA 36 SURGICAL SUCTION PUMP is a suction pump particularly suited for use in hospital
wards, in patients with tracheotomy, in small surgical applications and post-operative treatments at home. A
device that can be used for nasal, oral and tracheal aspirations in adults or for body liquids in children (for
example mucus, phlegm and blood). A device designed to offer ease-of-transport and almost continuous use
thanks to the adoption of an electronic system to manage the power supply. Supplied with an audible alarm
and visual tell-tale (luminous LED) to indicate the battery status. Featuring a body in plastic with high thermal
and electrical insulation in compliance with recently introduced European safety regulations. Supplied com-
plete with sterilizable polycarbonate jug with overow valve. Features a suction regulator and vacuum gauge
located on the front panel.
GENERAL WARNING
Read instruction manual carefully before use. The device is for use by qualied personnel (surgeon / profes-
sional 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 be 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 be inspected for
visual damage. Check the mains cable and do not connect to power if damage is apparent;
2. Before connecting the appliance always check that the electric data indicated on the data label and the type
of plug used, correspond to those of the mains electricity to which it’s to be connected;
3. Respect the safety regulations indicated for electrical appliances and particularly:
- Use original components and accessories provided by the manufacturer to guarantee the highest ef-
ciency and safety of the device;
- The device can be used only with the bacteriological lter;
- Never immerge the appliance into water;
- 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 thorough-
ly checked by qualied personnel and/or the GIMA technical service department.
- Position the device on stable and at surfaces in a way that the air inlets on the back aren’t obstructed;
- To avoid incidents, do not place the aspirator on unstable surfaces, which may cause it to accidentally fall
and lead to a malfunction and/or breakage. Should there be signs of damage to the plastic parts, which
may expose inner parts of the energised device, do not connect the plug to the electrical socket. Do not
attempt to make the device work before it has been thoroughly checked by qualied personnel and/or the
GIMA technical service department.
- Don’t use in the presence of inammable substances such as anaesthetic, oxygen or nitrous oxide;
- Don’t touch the device with wet hands and always prevent the appliance coming into contact with liquids;
- Don’t leave the appliance connected to the power supply socket when not in use;
- Don’t pull the power supply cable to disconnect the plug remove the plug from the mains socket correctly;
- Store and use the device in places protected against the weather and far from any sources of heat. After
each use, it is recommended to store the device in its own box away from dust and sunlight.
- In general, it is inadvisable to use single or multiple adapters and/or extensions. Should their use be
necessary, you must use ones that are in compliance with safety regulations, however, taking care not to
exceed the maximum power supply tolerated, which is indicated on the adapters and extensions.
- Prevent children from using the device without proper supervision;
- Never leave the appliance near water, do not immerse it in any liquid. If the device has fallen into water,
unplug it before you hold it. Do not use the appliance if the plug or AC / DC power supply is damaged or
wet (send it immediately to an authorized service center or technical service).
4. For repairs, exclusively contact technical service and request the use of original spare parts. Failure to
comply with the above can jeopardise the safety of the device;
5. Use only for the purpose intended. Don’t use for anything other than the use dened by the manufacturer.
The manufacturer will not be responsible for damage due to improper use or connection to an electrical
system not complying with current regulation.

16
ENGLISH
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
SUPER VEGA 36 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 has 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 seri-
ously 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 specic 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 facultiesas 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 mod-
ied, repaired without authorization or should any of its component be damaged due to accident or misuse.
Any minimal modication / repair on the device voids the warranty and does not guarantee the compliance
with the technical requirements provided by the MDD 93/42/EEC (and subsequent changes) and its norma-
tives.
CONTRAINDICATIONS
- Before using the SUPER VEGA 36 SUCTION 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.
- SUPER VEGA 36 SUCTION ASPIRATOR is not suitable for MRI. Do not introduce the device in MRI envi-
ronments.
TECHNICAL CHARACTERISTICS
Model SUPER VEGA 36 SUCTION ASPIRATOR
Typology (MDD 93/42/EEC) Class IIa Medical device
UNI EN ISO 10079-1 Classication High Vacuum / High Flow
Power Feeding 14V 4A with AC/DC adapter (input: 100-240V~ - 50/60Hz
- 100VA) or Internally powered equipment (Pb Battery
12V 4A) or with cigarette lighter adapter (12V 4A)
Current Consumption 4.0A
Maximum Suction Pressure (without jar) -80kPa (-0.80 Bar)
Minimum Suction Pressure (without jar) Less -40kPa (-0.40 bar)
Maximum Suction Flow (without jar) 36 l/min
Insulation Class (when used with the AC/DC adapter) Class II

17 ENGLISH
CLEANING OF THE DEVICE
Use a soft dry cloth with not – abrasive and not – solvent detergents. To clean the device external parts always
use a cotton cloth dampened with detergent. Don’t use abrasive or solvent detergents.Before carrying out
any cleaning and / or maintenance operation, disconnect the appliance from the power supply, unplugging it
or turning off the switch on the device.
Particular care should be taken to ensure that the internal parts of the equipment do not get in
touch with liquids. Never clean the equipment under water.
During all clearing operations use protection gloves and apron (if need be, also wear a face mask and glass-
es) to avoid getting in contact with contaminating substances (after each utilization cycle of the machine).
ACCESSORIES SUPPLIES
• Complete aspiration jar 1000ml
• Conical tting
• Tubes set 8 mm x 14 mm
• Hydrophobic and antibacterial lter
• AC/DC adapter
• Power supply cord for AC/DC adapter
• Cigarette ligther cable
Available under request with different versions with complete jar 2000ml.
The lter is produced with (PTFE) hydrophobic material to prevent uids entering the pneumatic circuit.
It should be changed immediately if it becomes wet or if there is any sign of contamination or discolouration.
If should also be changed if the unit is used with a patient whose risk of contamination is unknown. Don’t use
the suction unit without the protection lter. If the suction unit is used in an emergency or in a patient where
the risk of contamination is not known the lter must be changed after each use.
The lter is not designed to be decontaminated, disassembled and/or sterilised. If the patient’s pathology is
known and/or no risk of indirect contamination exists, it is advisable to replace the lter after each work shift
or at any rate on a monthly basis even if the device is not used.
WARNING: Suction tubes for insertion in the human body purchased separately from the machine
should comply with ISO 10993-1 standards on material biocompatibility.
Insulation Class (when used with an Internal battery) Internally Powered Equipment
Insulation Class (when used with a car cigarette
lighter cable) Class II
Weight 4.06Kg
Size 350 x 210 x 180 mm
Battery Holding Time 60 minutes
Battery Time Charge 240 minutes
Accuracy of Vacuum Indicator ± 5%
Working Condition Room temperature: 5 ÷ 35°C
Room humidity percentage: 10 ÷ 93 % RH
Atmospheric pressure: 800 ÷ 1060 hPa
Conservation condition and Transport Room temperature: - 25 ÷70 °C
Room humidity percentage: 0 ÷ 93% RH
Atmospheric pressure: 500 ÷ 1060 hPa

18
Aspiration jar: the mechanical resistance of the component is guaranteed up to 30 cycles of cleaning and
sterilization. Beyond this limit, the physical-chemical characteristics of the plastic material may show signs of
decay. Therefore, we recommend that you change it.
Silicone tubes: the number of cycles of sterilization and/or cleaning is strictly linked to the employment of the
said tube. Therefore, after each cleaning cycle, it is up to the nal user to verify whether the tube is suitable
for reuse. The component must be replaced if there are visible signs of decay of the material constituting the
said component.
Conical tting: the number of cycles of sterilization and the number of cleaning cycles is strictly linked to
the employment of the said component. Therefore, after each cleaning cycle, it is up to the nal user to verify
whether the tting is suitable for reuse. The component must be replaced if there are visible signs of decay in
the material constituting the said component.
Service life of the device: more than 1000 hours of operation (or 3 years) in accordance with the standard
conditions of testing and operation. Shelf life: maximum 5 years from the date of manufacture.
WARNING: The medical device is provided without a specic suction probe. If this device must be
used with a specic suction probe, the end user is responsible for making sure it complies with the
EN 10079-1 regulation.
CLEANING OF ACCESSORIES
Before using the device, the manufacturer advises you to clean and/or sterilize the accessories. Washing and
/ or cleaning the autoclavable jar is to be carried out as follows:
• Wear protection gloves and apron (glasses and face mask if necessary) to avoid contact with contaminat-
ing substances.
• Disconnect the tank from the device and remove the said container from the support of the device.
• Separate all the parts of the cover (overow device, washer).
• Disconnect all tubes from the jar and the protection lter.
• Wash each part of the container from secretions under cold running water and then clean every single part
in hot water (temperature not exceeding 60°C).
• Once again, carefully wash each single part using, if necessary, a non-abrasive brush to remove any de-
posits. Rinse with hot running water and dry all parts with a soft cloth (non-abrasive). It is possible to wash
with commercial disinfectants by carefully following the instructions and dilution values supplied by the
manufacturer. After cleaning, leave the parts to dry in an open, clean environment.
• Dispose of the aspiration catheter according to the provisions of local laws and regulations.
The jug and lid can be further disinfected using a common disinfectant, strictly following the instructions and
dilution values provided by the manufacturer. At the end of cleaning operations, leave 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 proce-
dure:
• Place the overow valve into its seat in the cover (under VACUUM connector)
• Insert oating valve keeping the o-ring towards the opening of the cage
• Place the o-ring into its seat around the cover
• After completing assembling operations always make sure that cover seals perfectly to avoid vacuum
leakages 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.
ENGLISH

19
After sterilization and cooling at environment temperature of the parts make sure that these are not damaged.
The aspiration tubes can be sterilized on autoclave using a sterilization cycle at 121°C (1 bar relative pres-
sure – 15 min).
The conical connector can be sterilized on autoclave using a sterilization cycle at 121°C (1 bar relative pres-
sure – 15 min).
DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER
PERIODICAL MAINTENANCE CHECKS
The SUPER VEGA 36 SUCTION ASPIRATOR suction equipment 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 AC/DC switching adapter ,
feeding cable, they might have been damaged during previous use. Connect cable to electrical network and
turn switch on. Close the aspirator outlet with your nger and with suction regulator in maximum vacuum
position check that the vacuum indicators reaches – 80kPa (-0.80 bar) minimum (internal battery). Rotate the
knob from right to left and check the aspiration regulating control. The vacuum indicator should go down –
40kPa (-0.40 bar). Verify that loud noises are not present, these can indicate wrong functioning. 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 specications) 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
qualied 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 made up of a lead battery which cannot be accessed from the outside. In order to replace it,
consult the technical staff authorised by the manufacturer.
ENGLISH
Fault type Cause Solution
1. Red light on Battery run down Hook up the power cord to the electricity mains,
positioning the equipment power switch on 0.
2. No light Defective AC/DC adapter or technical
internal problem Contact the technical service.
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 oat doesn’t close If the cap has been washed, ensure
that the oat is not partially detached Insert the oat into it’s place
6. The oat doesn’t close The oat it’s covered by dirty material Unscrewed the cap, leave the and put in on au-
toclave
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 Filter blocked Replace lter
9. The Vacuum power
on the patient side is either
very low or absent
• 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
• 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
• Contact the technical service
10. Noisy Technical internal problem Contact 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 Assis-
tance Service

20
USE ONLY THE RECOMMENDED BATTERIES FROM GIMA. THE USE OF OTHER BATTERIES IS
NOT RECOMMENDED AND INVOLVES THE CANCELLATION OF WARRANTY
In the event that the service personnel has to replace the internal battery, pay special attention to the polarity
of the same component. The + / - polarities are indicated directly on the battery.
If the overll security system is activated, don’t proceede with the liquid aspiration. If the overll security sys-
tem doesn’t work there are two cases:
1st case – If the overll security system doesn’t work the aspiration will be stopped by the bacteriological lter
who avoids the liquid penetration inside the device.
2nd case – If both the security system and the bacteriological ltrer do not work, there is the possibility that
liquid has leaked 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 in-
structions 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 identify any operating faults and/or damage due
to transport and/or storage.
· The work surface must be at and stable in order that the control panel can be reached and so that the
vacuum gauge, vase and antibacterial lter are clearly visible.
· It is recommended not to hold the device in your hand and/or avoid prolonged contact with the body of the
device.
WARNING: For correct use, position the suction unit on a at and stable surface, thus maximising the
available volume of the vase and improving the efciency of the overow device.
Operation with AC/DC power pack:
• Connect the short silicone tube with the antibacterial lter to the suction port. The other tube, connected to
the lter on one end, must be connected to the spout on the vase lid with the oat assembled inside (over-
ow device). The overow device is triggered (the oat closes off the internal lid tting) when the maximum
volume (90% of the effective vase volume) is reached, thus preventing the liquid from penetrating the inside
of the machine. The device must be used on a at, horizontal surface.
• Connect the long silicone tube to the free spout on the lid; the free end of the tube must be connected to
the conical tting for the probe coupling, to which the suction probe must then be connected.
• Connect the universal power pack to the device using the dedicated connector and insert the power cord
plug into the socket. To start the treatment, press the switch into position I to turn the device on
• Set the desired vacuum level (Bar / kPa) through the vacuum regulator. Turn the knob in a clockwise direc-
tion to increase the vacuum level: these values can be read on the “vacuum gauge”.
• To suspend and/or end the treatment, press the switch again and pull the plug out of the socket
• To mitigate the formation of foam inside the vase, unscrew and remove the lid from the vase, and ll the
latter with 1/3 water (to facilitate cleaning operations and speed up depressurisation during operation), then
screw the lid back onto the vase.
• Remove the accessories and proceed with cleaning operations.
• At the end of each use place the device back in the box, protected against dust
WARNING: The power cord plug is the element of separation from the electrical mains, even if the device is
equipped with an on/off button. Once the device is in use, the power plug must remain accessible to allow
ENGLISH

21
another method of disconnection from the electrical mains.
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 insufcient 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.
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”)
Operation with Internal Battery
• Press the switch in position I to turn the device on (the external power pack doesn’t need to be connected)
• The fully charged battery life is about 60 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).
Recharging operations: to be able to charge the internal battery it is necessary to connect the universal
switching adapter to the electric network for approx. 240 minutes with the main switch to position 0.
TAB. I – INDICATOR LIGHTS DURING OPERATIONS
When an external power supply is connected (regardless of the state of the battery charger) and when the
device is working (after having turned it on), the LED stays in a FIXED GREEN position.
ENGLISH

22
NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER
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 SUPER VEGA 36 SUCTION surgical aspirator is an electro-medical device that requires particular pre-
cautions 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
conguration (for example, constantly and visually checking for the absence of anomalies or malfunctions).
The use of accessories, transducers and cables differing from those specied, with the exception of trans-
LED Signal Phase Problem / Cause Solution
Flashing Green
Led
During rechanrge Battery recharge running Wait
Steady Greed Led During rechanrge Recharging cycle
complete
Remove power supply
Steady Red Led During battery
operation
Flat battery Start recharging cycle
WARNING: During this signal, you will hear a
long, continuous beep (duration of sound 0.8
sec / sound frequency: every 8.5 sec), which
noties the user regarding the battery dis-
charge.
Flashing Red Led Device automatically
turns off when the
battery is at
Battery completely at When the device is restarted the LED will ash
red: begin the battery recharge cycle immedi-
ately
Steady Orange Led During battery
operation
Intermediate status Guaranteed battery function / Recharge when
the red LED signal comes on.
ENGLISH

23
ducers 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.
ENGLISH
Guidance and manufacturer’s declaration – electromagnetic Emissions
The SUPER VEGA 36 SUCTION ASPIRATOR is intended for use in the electromagnetic environment specied below.
The customers or the user of the SUPER VEGA 36 SUCTION ASPIRATOR should make sure that it’s used in such an
environment.
Emissions test Compliance Electromagnetic environment - guidance
Irradiated / Conducted
emissions CISPR11 Group 1 The SUPER VEGA 36 SUCTION 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 ap-
pliances.
Irradiated / Conducted
emissions CISPR11 Class [B] The SUPER VEGA 36 SUCTION 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 uctuations / icker
emissions EN 61000-3-3
Complies
Guidance and manufacturer’s declaration – Immunity Emissions
The SUPER VEGA 36 SUCTION ASPIRATOR is intended for use in the electromagnetic environment specied below.
The customers or the user of the SUPER VEGA 36 SUCTION ASPIRATOR should make sure 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
+/-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 ma-
terial, 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
+/-2 kV ordinary 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 typ-
ical commercial environment or hospital If
the user of the SUPER VEGA 36 SUCTION
ASPIRATOR request that the appliance oper-
ates continuously, the use of a continuity unit
is recommended.
Magnetic eld with
network frequency
(50/60 HZ)
EN 61000-4-8
30A/m The device doesn’t
change its state
The power frequency magnetic eld should
be measured in the intended installation lo-
cation to make sure that it’s sufciently low.
Note UT is the value of the power supply voltage

24
Guidance and manufacturer’s declaration – Immunity Emissions
The SUPER VEGA 36 SUCTION ASPIRATOR is intended for use in the electromagnetic environment specied below.
The customers or the user of the SUPER VEGA 36 SUCTION ASPIRATOR should make sure 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
Radiated
Immunity
EN 61000-4-3
3Vrms 150kHz
to 80Mhz
(for non life-supporting
devices)
10V/m 80MHz
to 2.7GHz
(for non life-supporting
devices)
V1 = 3 V rms
E1 = 10 V / m
The portable and mobile RF communication devices,
including cables, must not be used closer to the SU-
PER VEGA 36 device, than the separation distance
calculated by the equation applicable to the transmitter
frequency.
Recommended separation distance
from 80 MHz to 800MHz
from 800 MHz to 2.7 GHz
Where Pis 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 site
a)
, could be lower than the
level of conformity of each frequency interval
b)
.
It is possible to check for interference in
proximity to devices identied by the fol-
lowing 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 inuenced by the
absorption and by reection 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-magnet-
ic study of the site should be considered. If the eld intensity measured in the place where the device will be used surpass-
es the above mentioned applicable level of conformity, the normal functioning of the device should be monitored. If abnor-
mal 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.
3,5
V 1
√P
d=
12
E 1
√P
d=
23
E 1
√P
d=
ENGLISH

25 ENGLISH
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
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 Pis 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 inuenced by the
absorption and by the reection from buildings, objects and people
3,5
V 1
√P
d=12
E 1
√P
d= 23
E 1
√P
d=
Caution: read instructions (warnings) carefully Consult instructions for use
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 Type BF applied part
WEEE disposal Class II applied
Serial number Store between -25 and 70°C
Battery Atmospheric Pressure
Direct current
~
Alternating current
IP21
Covering Protection rate
Hz
Mains frequency
ON / OFF
SYMBOLS
the technical specications may change without notice

26
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 specic recycling point for electric and electronic equipment.
For further information on recycling points contact the local authorities, the local recycling center or
the shop where the product was purchased. If the equipment is not disposed of correctly, nes or
penalties may be applied in accordance with the national legislation and regulations.
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 Ofce, your household
waste disposal service or the shop where you purchased the product.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product.
This product meets high qualitative standards both as regards the material and the production. The warranty
is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected
parts due to production reasons. Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall not extend the warranty.
The warranty is void in the following cases: repairs performed by unauthorized personnel or with non-original
spare parts, defects caused by negligence or incorrect use.
GIMA cannot be held responsible for malfunctioning on electronic devices or software due to outside agents
such as: voltage changes, electro-magnetic elds, radio interferences, etc.
The warranty is void if the above regulations are not observed and if the serial code (if available) has been
removed, cancelled or changed.
The defected products must be returned only to the dealer the product was purchased from. Products sent
to GIMA will be rejected.
ENGLISH