Gima SUPER VEGA BATTERY User manual

ASPIRATORE SUPER VEGA BATTERY
SUPER VEGA BATTERY SUCTION UNIT
ASPIRATEUR SUPER VEGA BATTERY
SAUGER SUPER VEGA BATTERY
ASPIRADOR SUPER VEGA BATTERY
ASPIRADOR SUPER VEGA BATTERY
SSAK AKUMULATOROWY SUPER VEGA BATTERY
ASPIRATOR SUPER VEGA BATTERY
ΣΥΣΚΕΥΗ ΑΝΑΡΡΟΦΗΣΗΣ SUPER VEGA BATTERY
M28243-M-Rev.2-09.20
PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Made in Italy
28243 0476

15 ENGLISH
SUPER VEGA BATTERY SUCTION UNIT 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. The luminous LED positioned on the
front panel indicates its activation and the charge status of the device. Its body is made from plastic with high
thermal and electrical insulation in compliance with recently introduced European safety regulations. Sup-
plied 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 / professional nurse / assistant)
The use of the device at home is restricted to an adult in full possession of mental faculties and / or home
carers
The instrument must not disassembled. For technical service always contact Gima S.p.A.
IMPORTANT SAFETY RULES
1. Check the condition of the unit before each use. The surface of the unit should carefully inspected for visual
damage.
Check the mains cable and do not connect to power if damage is apparent;
2. Before connecting the appliance always check that the electric data indicated on the data label and the type
of plug used, correspond to those of the mains electricity to witch it’s to be connected;
3. Respect the safety regulations indicated for electrical appliances and particularly:
- Use original components and accessories provided by the manufacturer to guarantee the highest 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.
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.
6. The medical device requires special precautions regarding electromagnetic compatibility and must be in-
stalled and used in accordance with the information provided with the accompanying documents: the SU-

16
ENGLISH
PER VEGA BATTERY SUCTION UNIT 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 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 faculties as they may strangle themselves with the patient’s tube and/or the power cable.
The manufacturer cannot be held liable for accidental or indirect damages should the device
be modied, repaired without authorization or should any of its component be damaged due to acci-
dent or misuse.
Any minimal modication / repair on the device voids the warranty and does not guarantee the com-
pliance with the technical requirements provided by the MDD 93/42/EEC (and subsequent changes)
and its normatives.
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 SUPERVEGA BATTERY 230/12V
Typology (MDD 93/42/EEC) Class IIa Medical device
UNI EN ISO 10079-1 Classication HIGH VACUUM / LOW 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)
Maximum Suction Pressure (without jar) -75kPa (- 0.75 bar)
Minimum Suction Pressure (without jar) Less -25kPa (-0.25 bar)
Maximum Suction Flow (without jar) 16 l /min
Weight 3.50 Kg
Insulation Class (when used with the AC/DC adapter) Class II

17 ENGLISH
The technical specications may change without notice
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 6 mm x 10 mm
• Hydrophobic and antibacterial lter
• AC/DC adapter
• Power supply cord for ac/dc adapter
• Cigarette ligther cable
On request, versions with a complete 2000ml jar are also available.
Antibacterial and hydrophobic lter: designed for a single patient with the aim of protecting patient and
machine against infections cross. It blocks the passage of the liquids that come into contact with it. Always
replace it if yes suspected to be contaminated and / or wetted or discolored. If the aspirator is used on patients
in pathological situations not known and where it is not possible to assess any indirect contamination, replace
the lter after each use. The lter is not designed to be decontaminated, disassembled and / or sterilized.
In case the pathology of the patient and / or is knownwhere there is no danger of indirect contamination, we
recommend replacing the lter after each work shift or otherwise every 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
Insulation Class (when used with an Internal battery) Internally Powered Equipment
Insulation Class (when used with a car cigarette
lighter cable) Class II
Size 350 x 210 x 180 mm
Battery Holding Time 80 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
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 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.
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 (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 deposits.
Rinse with hot running water and dry all parts with a soft cloth (non-abrasive). It is possible to wash with com-
mercial disinfectants by carefully following the instructions and dilution values supplied by the manufacturer.
After cleaning, leave the parts to dry in an open, clean environment.
• Dispose of the aspiration catheter according to that provided by local laws and regulations.
The silicone aspiration tubes and the conical 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 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 sue that cover seals perfectly to avoid vacuum leack-
ages 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 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).
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19
DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER
PERIODICAL MAINTENANCE CHECKS
The SUPER VEGA BATTERY SUCTION UNIT 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. Un-
pack 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 -75kPa (-0.75 bar) minimum (internal battery). Rotate the knob from right to
left and check the aspiration regulating control. The vacuum indicator should go down -25kPa (-0.25 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 F1, F2 (T 15A L 125V) that can-
not be reached from the outside. Therefore, contact the manufacturer to request the assistance of an author-
ized 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 by outside. In order to replace it, consult
the technical staff authorised by the manufacturer.
USE ONLY THE RECOMMENDED BATTERIES FROM GIMA. THE USE OF OTHER BATTERIES
ARE NOT RECOMMENDED AND INVOLVING 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.
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

20
If the overll security system it’s activated, don’t proceede with the liquid aspiration. If the overll security
system 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 INSTRU-
MENT, 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
another method of disconnection from the electrical mains.
ENGLISH
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

21
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.
ENGLISH

22
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.
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 BATTERY SUCTION UNIT surgical aspirator is an electro-medical device that requires
particular precautions regarding electro-magnetic compatibility and which must be installed and commis-
sioned according to the electro-magnetic compatibility information supplied. Portable and mobile radio com-
munication 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
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
or malfunctions). The use of accessories, transducers and cables differing from those specied, with the ex-
ception 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.
ENGLISH
Guidance and manufacturer’s declaration – electromagnetic Emissions
The SUPER VEGA BATTERY SUCTION UNIT is intended for use in the electromagnetic environment specied below.
The customers or the user of the SUPER VEGA BATTERY SUCTION UNIT 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 BATTERY SUCTION UNIT 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 BATTERY SUCTION UNIT 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 BATTERY SUCTION UNIT is intended for use in the electromagnetic environment specied below.
The customers or the user of the SUPER VEGA BATTERY SUCTION UNIT 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 typi-
cal commercial environment or hospital If the
user of the SUPER VEGA BATTERY SUC-
TION UNIT 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 BATTERY SUCTION UNIT is intended for use in the electromagnetic environment specied below.
The customers or the user of the SUPER VEGA BATTERY SUCTION UNIT 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 BATTERY SUCTION UNIT device, than the
separation distance calculated by the equation applica-
ble to the transmitter frequency.
Recommended separation distance
from 80 MHz to 800MHz
from 800 MHz to 2.7 GHz
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 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 BATTERY SUCTION UNIT surgical aspirator is intended to operate in an electro-magnetic envi-
ronment where RF irradiated interferences are under control. The client or operator of the SUPER VEGA BATTERY
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 SUPER VEGA BATTERY 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
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 Follow 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 Temperature limit
Battery Atmospheric Pressure limit
Direct current
~
Alternating current
IP21
Covering Protection rate
Hz
Mains frequency
ON / OFF Humidity limit
SYMBOLS

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.
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 TERMS
The Gima 12-month standard B2B warranty applies.
ENGLISH