Medutek KATASPIR 230/12BR User manual

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KATASPIR 230/12BR
Suction Unit
Instruction Manual
English (EN)

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GB
GENERAL WARNING..................................................................................................................................................................................................... 16
IMPORTANT SAFETY RULES .............................................................................................................................................................................16-17
TECHNICAL CHARACTERISTICS .............................................................................................................................................................................17
SYMBOLS............................................................................................................................................................................................................................18
CLEANING DEVICE ........................................................................................................................................................................................................18
ACCESSORIES SUPPLIES.............................................................................................................................................................................................19
CLEANING OF ACCESSORIES .............................................................................................................................................................................19-20
PERIODICAL MAINTENANCE CHECKS ..........................................................................................................................................................20-21
INSTRUCTION FOR USE .......................................................................................................................................................................................21-23
RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES ...............................................................................23-25
WARRANTY CONDITIONS..........................................................................................................................................................................................25
RULES FOR RETURNING AND RAPAIRING ........................................................................................................................................................25

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KATASPIR 230/12BR is a surgical aspirator with the following electrical features : 14V 4A with AC/DC adapter mod. UE60-
140429SPA1 of FUHUA (input: 100-240V~ - 50/60Hz - 100VA) or Internally powered equipment (Pb Battery 12V 4A) or
with cigarette lighter adapter (12V 4A). KATASPIR 230/12BR is a desk-type electric suction unit for the aspiration of body
liquids, oral, nasal and tracheal aspiration in adults or children. The appliance is designed for easy transport and almost
continuous use. The unit is operated by means of an electronic power management system, also monitoring the internal battery
operation and status. Provided with visual and acoustic alarm indicating low battery level, the main unit is also equipped with
vacuum-meter (bar & kPa) and vacuum regulator on the front panel.
Thanks to these characteristics and to its functions, this device is particularly suitable for different applications: utilization in
hospital wards, for tracheotomy, for suction of body liquids and for minor surgery.
GENERAL WARNING
READ INSTRUCTION MANUAL CAREFULLY BEFORE USE.
THE DEVICE IS FOR USE BY QUALIFIED PERSONNEL (SURGEON / PROFESSIONAL NURSE / ASSISTANT)
THE USE OF THE DEVICE AT HOME IS RESTRICTED TO AN ADULT IN FULL POSSESSION OF MENTAL FACULTIES AND / OR
HOME CARERS
THE INSTRUMENT MUST NOT DISASSEMBLED. FOR TECHNICAL SERVICE ALWAYS CONTACT MEDUTEK
IMPORTANT SAFETY RULES
1. Check the condition of the unit before each use. The surface of the unit should carefully inspected for visual damage.
Check the mains cable and do not connect to power if damage is apparent;
2. Before connecting the appliance always check that the electric data indicated on the data label and the type of plug used,
correspond to those of the mains electricity to witch it’s to be connected;
3. Respect the safety regulations indicated for electrical appliances and particularly:
•Use original components and accessories provided by the manufacturer to guarantee the highest efficiency and safety
of the device;
•The device can be used only with the bacteriological filter;
•Never immerge the appliance into water;
•Do not place or store the aspirator in places where it may fall or be pulled into the bathtub or washbasin. In the event
it is accidentally dropped, do not attempt to remove the device from the water whilst the plug is still connected:
disconnect the mains switch, remove the plug from the power supply and contact the MEDUTEK technical service
department. Do not attempt to make the device work before it has been thoroughly checked by qualified personnel
and/or the MEDUTEK technical service department.
•Position the device on stable and flat surfaces in a way that the air inlets on the back aren’t obstructed;
•To avoid incidents, do not place the aspirator on unstable surfaces, which may cause it to accidentally fall and lead to a
malfunction and/or breakage. Should there be signs of damage to the plastic parts, which may expose inner parts of
the energised device, do not connect the plug to the electrical socket. Do not attempt to make the device work
before it has been thoroughly checked by qualified personnel and/or the MEDUTEK technical service department.
•Don’t use in the presence of inflammable substances such as anaesthetic, oxygen or nitrous oxide;
•Don’t touch the device with wet hands and always prevent the appliance coming into contact with liquids;
•Don’t leave the appliance connected to the power supply socket when not in use;
•Don’t pull the power supply cable to disconnect the plug remove the plug from the mains socket correctly;
•Store and use the device in places protected against the weather and far from any sources of heat. After each use, it is
recommended to store the device in its own box away from dust and sunlight.
•In general, it is inadvisable to use single or multiple adapters and/or extensions. Should their use be necessary, you
must use ones that are in compliance with safety regulations, however, taking care not to exceed the maximum power
supply tolerated, which is indicated on the adapters and extensions.
4. For repairs, exclusively contact technical service and request the use of original spare parts.
Failure to comply with the above can jeopardise the safety of the device;
5. Use only for the purpose intended. Don’t use for anything other than the use defined by the manufacturer.
The manufacturer will not be responsible for damage due to improper use or connection to an electrical system not
complying with current regulation.
6. The medical device requires special precautions regarding electromagnetic compatibility and must be installed and used in
accordance with the information provided with the accompanying documents: the KATASPIR 230/12BR 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 MEDUTEK. 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.

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10. The medical device is in contact with the patient by means of a disposable probe (not supplied with the device).
Suction tubes for insertion in the human body purchased separately from the machine should comply with ISO 10993-1
standards on material biocompatibility.
11. The product and its parts are biocompatible in accordance with the requirements of regulation EN 60601-1.
12. Operation of the device is very simple and therefore no further explanations are required other than those indicated in the
following user manual.
13. The lead battery integrated in the device is not to be considered as an ordinary domestic waste. Such a component must be
disposed of in a specific collection centre in order to be recycled.
14. Use in Home-Care: Keep all accessories of the device out of reach of children under 36 months of age since they contain
small parts that may be swallowed.
15. Do not leave the device unattended in places accessible to children and/or persons not in full possession of mental faculties
as they may strangle themselves with the patient's tube and/or the power cable.
The manufacturer cannot be held liable for accidental or indirect damages should the device be modified,
repaired without authorization or should any of its component be damaged due to accident or misuse.
Any minimal modification / repair on the device voids the warranty and does not guarantee the compliance
with the technical requirements provided by the MDD 93/42/EEC (and subsequent changes) and its
normatives.
CONTRAINDICATIONS
-Before using the KATASPIR 230/12BR, consult the instructions for use: failure to read all the instructions in this manual
can be harmful for the patient.
-Don’t use the device thoracic drainage.
-The device must not be used for suction of explosive, corrosive or easily flammable liquids.
-KATASPIR 230/12BR is not suitable for MRI. Do not introduce the device in MRI environments.
DISPOSAL OF WASTE BATTERIES - (Directive 2006/66/EC)
This symbol on the battery or on the packaging indicates that the battery provided with this product shall not be
treated as household waste. By ensuring these batteries are disposed of correctly, you will help prevent potentially
negative consequences for the environment and human health which could otherwise be caused by inappropriate
waste handling of the battery. The recycling of the materials will help to conserve natural resources.
At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries.
For more detailed information about recycling of this product or battery, please contact your local Civic Office, your
household waste disposal service or the shop where you purchased the product.
TECHNICAL CHARACTERISTICS
Model
KATASPIR 230/12BR
Typology (MDD 93/42/EEC)
Class IIa Medical device
UNI EN ISO 10079-1 Classification
HIGH VACUUM / LOW FLOW
Power Feeding
14V 4A with AC/DC adapter mod. UE60-140429SPA1
of FUHUA (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 mod.
UE60-140429SPA1)
Class II
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
Accurancy 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

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SYMBOLS
Insulation Class II (when used with AC / DC adapter or when connected
to a car cigarette lighter cable)
CE marking in conformity with EC directive 93/42/CEE and subsequent
changes
General warnings and/or specifications
Consult the instruction manual
Manufacturer: CA-MI S.r.l.
Via Ugo La Malfa nr.13 – Frazione Pilastro
43013 Langhirano (PR) Italia
Applied Part type BF (suction probe)
Keep in a cool, dry place
Conservation temperature: - 25 ÷ 70° C
Atmospheric Pressure
Battery
Direct Current
Hz
Mains frequency
ON / OFF
Batch production
Serial number
Model / Ref number
IP21
Degree of protection an electrical device provides in the case of
accidental or intentional contact with the human body or with objects,
and protection in the case of contact with water.
1st DIGIT
PENETRATION OF SOLIDS
2nd DIGIT
PENETRATION OF LIQUIDS
Protected against solids having a
dimension greater than Ø 12mm
Protected against the vertical
flow of drops of water
Device approved according to international standards ECE-R10
CLEANING DEVICE
Use a soft dry cloth with not – abrasive and not – solvent detergents. To clean the device external parts always use a cotton cloth
dampened with detergent. Don’t use abrasive or solvent detergents.
PARTICULAR CARE SHOULD BE TAKEN TO ENSURE THAT THE INTERNAL PARTS OF THE EQUIPMENT DO
NOT GET IN TOUCH WITH LIQUIDS. NEVER CLEAN THE EQUIPMENT WITH WATER.
During all clearing operations use protection gloves and apron (if need be, also wear a face mask and glasses) to avoid getting in
contact with contaminating substances (after each utilization cycle of the machine).
10R-052100

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ACCESSORIES SUPPLIES
DESCRIPTION
CODE
1000 ml JAR, reusable
048-210001
Cover for 1000 ml jar
048-210352
Silicone Tubing Set with Filter
033-04820
Filter
392-080466
The filter is produced with (PTFE) hydrophobic material to prevent fluids entering the pneumatic circuit. It should be changed
immediately if it becomes wet or if there is any sign of contamination or discolouration. If should also be changed if the unit is used
with a patient whose risk of contamination is unknown. Don’t use the suction unit without the protection filter. If the suction
unit is used in an emergency or in a patient where the risk of contamination is not know the filter must be changed after each use.
Available under request with different versions with complete jar 2000ml.
Suction catheter: Single-use device to be used on a single patient. Do not wash or re-sterilize after use. Reuse may cause cross-
infections. Don’t use after lapse of the sell-by date
Check the expiry date on the original packaging of the suction catheter and check the integrity of the sterile
packaging. MEDUTEK declines any liability for injury to the patient correlated to the deterioration of the above-
mentioned sterile packaging due to handling of the original packaging by third parties.
WARNING: Suction tubes for insertion in the human body purchased separately from the machine should comply with ISO
10993-1 standards on material biocompatibility.
Aspiration jar: The mechanical resistance of the component is guaranteed up to 30 cycles of cleaning and sterilization.
Beyond this limit, the physical-chemical characteristics of the plastic material may show signs of decay. Therefore, we recommend
that you to change it.
Silicone tubes: the number of cycles of sterilization and/or cleaning is strictly linked to the employment of the said tube.
Therefore, after each cleaning cycle, it is up to the final user to verify whether the tube is suitable for reuse. The component must
be replaced if there are visible signs of decay of the material constituting the said component.
Conical fitting: the number of cycles of sterilization and the number of cleaning cycles is strictly linked to the employment of the
said component. Therefore, after each cleaning cycle, it is up to the final user to verify whether the fitting is suitable for reuse.
The component must be replaced if there are visible signs of decay in the material constituting the said component.
Service life of the device: More than 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 contaminating
substances;
•Disconnect the tank from the device and remove the said container from the support of the device.
•Separate all the parts of the cover (overflow device, washer).
•Disconnect all tubes from the jar and the protection filter
•Wash each part of the container from secretions under cold running water and then clean every single part in hot
water (temperature not exceeding 60°C)
•Once again, carefully wash each single part using, if necessary, a non-abrasive brush to remove any deposits.
Rinse with hot running water and dry all parts with a soft cloth (non-abrasive). It is possible to wash with commercial
disinfectants by carefully following the instructions and dilution values supplied by the manufacturer.
After cleaning, leave the parts to dry in an open, clean environment.
•Dispose of the aspiration catheter according to that provided by local laws and regulations.
The silicone aspiration tubes and the conical fitting may be carefully washed in hot water (temperature must not exceed
60°C). After cleaning, leave the parts to dry in an open, clean environment.

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When cleaning is complete, reassemble the container for liquid aspirations according to the following procedure:
•Place the overflow valve into its seat in the cover (under VACUUM connector)
•Insert floating valve keeping the o-ring towards the opening of the cage
•Place the o-ring into its seat around the cover
•After completing assembling operations always make sue that cover seals perfectly to avoid vacuum leackages or
liquid exit
After disposing of disposable parts and disassembling the jar wash in running cold water and rinse thouroughly.
Then soak in warm water (temperature shall not exceed 60°C). Wash thouroughly and if necessary use a non-abrasive brush to
remove incrustations. Rinse in running warm water and dry all parts with a soft cloth (non-abrasive).
The jar and the cover can be autoclaved by placing the parts into the autoclave and running one sterilization stem cycle at 121°C
(1 bar relative pressure – 15 min) making sure that the jar is positioned upsidedown. Mechanical resistance of the jar is
guaranteed up to 30 cycles of sterilization and cleaning at the indicated conditions (EN ISO 10079-1). Beyond this limit the
physical-mechanical characteristics of the plastic may decrease and replacement of the part is therefore recommended.
After sterilization and cooling at environment temperature of the parts make sure that these are not damaged.
The aspiration tubes can be sterilized on autoclave using a sterilization cycle at 121°C (1 bar relative pressure – 15 min).
The conical connector can be sterilized on autoclave using a sterilization cycle at 121°C (1 bar relative pressure – 15 min).
DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER
PERIODICAL MAINTENANCE CHECKS
The KATASPIR 230/12BR suction equipment does not need maintenance or lubrication.
It is, however to inspect the unit before each use. With regard to training, given the information contained in the user manual and
since it is easy to understand the said device, it doesn’t appear to be necessary. Unpack the instrument and always check integrity
of plastic parts 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 finger 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 specifications) by two fuses (T 15A L 125V) that cannot be reached from the
outside. Therefore, contact the manufacturer to request the assistance of an authorized and qualified technician when they need to
be replaced. If it’s replaced make sure that its replacement is always the same type and value, as indicated.
The device is 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.
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 float doesn’t close
If the cap has been washed,
ensure that the float is not
partially detached
Insert the float into it’s place
6. The float doesn’t close
The float it’s covered by dirty
material
Unscrewed the cap, leave the and put in on autoclave
7. Low suction
Foam inside the jar
Fill the jar to 1/3 full of ordinary water
8. No aspiration due to flow
leakage of mucus
Filter blocked
Replace filter
1. The Vacuum power on the
patient side is either very low
or absent
•Vacuum regulator set to
minimum
•Protection filter 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 filter
•Replace or reconnect the tubes, check the jar
connections
•Empty the jar, or disconnect the tube from the jar and
unblock the shut-off valve. The unit twill only work in
the upright position
•Contact the technical service
2. Noisy
Technical internal problem
Contcat the technical service
Faults 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 –
9 - 10
None of the remedies has
achieved the desired results
Contact the seller or MEDUTEK After-sales Assistance
Service

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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 MEDUTEK. 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.
If the overfill security system it’s activated, don’t proceede with the liquid aspiration. If the overfill security system doesn’t work
there are two cases:
1° case – If the overfill security system doesn’t work the aspiration will be stopped by the bacteriological filter who avoid the liquid
penetration inside the device.
2° case – If both the security system doesn’t work, there is the possibility that liquid comes inside the device, in this case return the
device to MEDUTEK technical service.
MEDUTEK 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
MEDUTEK TECHNICAL SERVICE. MEDUTEK DOES NOT GIVE GUARANTEE IF INSTRUMENT, AFTER THE
TECHNICAL SERVICE CHECKING, APPEARS TO BE TAMPERED.
IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC
DIRECTIVE 2012/19/UE-WEEE:
The symbol on the device indicates the separated collection of electric and electronic equipment. At the end of
life of the device, don’t dispose it as mixed solid municipal waste, but dispose it referring to a specific
collection centre located in your area or returning it to the distributor, when buying a new device of the
sample type to be used with the same functions.
This procedure of separated collection of electric and electronic devices is carried out forecasting a European
environmental policy aiming at safeguarding, protecting and improving environment quality, as well as avoiding potential effects
on human health due to the presence of hazardous substances in such equipment or to an improper use of the same or of parts of
the same Caution: The wrong disposal of electric and electronic equipment may involve sanctions.
INSTRUCTION FOR USE
•The device must be checked before each use in order to detect malfunctions and / or damage caused by transport and / or
storage.
•The working position must be such as to allow one to reach the control panel and to have a good view of the empty
indicator, the jar and the antibacterial filter.
•It is recommended not to keep the device in your hands and / or to avoid prolonged contact with the body of apparatus.
WARNING:For proper use, place the aspirator on a flat, stable surface in order to have the full volume of use of the jar and
better efficiency of the overflow device.
Operation using with AC/DC switching adapter
•Place the unit on a flat, horizontal surface.
•Connect the short silicon tube,with antibacterial filter, to the suction connector. The other tube, with one end connected to
the antibacterial filter with the other end to jar’s lid connector where has been fixed the red float. When the 90% of the
volume of the jar is reached there is the activation of the security float (the float close the aspiration connector on the jar) to
avoid liquid penetration inside the device.
•Connect the long silicon tube to the other jar's lid connector
•Connect the other end of the long silicon tube to the probe plastic connector then connect the suction probe to it.
•Connect the switching adapter to the device with the appropriate connector and insert the power cable plug to the power
socket. To start the treatment press the I switch to turn it on
•Set the desired vaccum value (Bar / kPa) with the appropriate vacuum regulator. Turning the handle clockwise increase the
vacuum value: these values can be read on the “vacuum indicator” instrument.
•To suspend and / o r terminate the treatment, press the switch againg and pull the plug out from the power socket.
•Unscrew the jar's lid and fill the jar 1/3 full or ordinary water (this for an easy cleaning operations and an rapid reaching of
the functionally vacuum) then rescrew the lid on the jar correctly.
•To extract the accessories and start with cleaning.
WARNING: Ensure that the FLUID SIDE or IN marker on the filter is on the side facing the collection jar lid and fitted into the
“VACUUM”. A wrong connection causes immediate destruction in case of contact with sucked liquids.

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Filter assembling
FLOW DIRECTION
Suction Pump
Inlet
Jar Air Tube
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.
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
(mod. UE 60140429SPA1 of FUHUA) to the electric network for approx. 240 minutes with the main switch to position 0.
The battery’s autonomy when fully charged is approx. 80 minutes with continued operations.
TAB. I – INDICATOR LIGHTS DURING OPERATIONS
When an external power supply (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.
LED Signal
Phase
Problem / Cause
Solution
Flashing Green Led
During rechanrge
Battery recharge running
Wait
Steady Greed Led
During recharge
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 notifies the user
regarding the battery discharge.
Flashing Red Led
Device automatically turns
off when the battery is flat
Battery completely flat
When the device is restarted the
LED will flash red: begin the
battery recharge cycle
immediately
Steady Orange Led
During battery operation
Intermediate status
Guaranteed battery function /
Recharge when the red LED
signal comes on.
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”)
NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER
IN / Fluid Inside
IN

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RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
This section contains information regarding the conformity of the compliance with the EN 60601-1-2 Standard.
The KATASPIR 230/12BR surgical aspirator is an electro-medical device that requires particular precautions regarding electro-
magnetic compatibility and which must be installed and commissioned according to the electro-magnetic compatibility
information supplied. Portable and mobile radio communication devices (mobile phones, transceivers, etc.) may interfere with
the medical device and should not be used in close proximity with, adjacent to or on top of the medical device. If such use is
necessary and unavoidable, special precautions should be taken so that the electro-medical device functions properly in its
intended operating configuration (for example, constantly and visually checking for the absence of anomalies or malfunctions).
The use of accessories, transducers and cables different to those specified, with the exception of transducers and cables sold by
the appliance and system manufacturer as spare parts, can lead to an increase in emissions or in a decrease of the immunity of
the device or system. The following tables supply information regarding the EMC (Electromagnetic Compatibility)
characteristics of the electro-medical device.
Guidance and manufacturer’s declaration – electromagnetic Emissions
The surgical aspirator KATASPIR 230/12BR is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator KATASPIR 230/12BR should assure that it’s used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
Irradiated / Conducted emissions
CISPR11
Group 1
The surgical aspirator KATASPIR 230/12BR only used RF
energy only for its internal functioning. Therefore, its RF
emissions are very low and are not cause interference in
proximity of any Electronic appliances.
Irradiated / Conducted emissions CISPR11
Class [B]
The surgical aspirator KATASPIR 230/12BR can be used in
all environments, including domestic and those connected
directly to the public mains distribution that supplies power
to environments used for domestic scopes.
Harmonic emissions EN 61000-3-2
Class [A]
Voltage fluctuations / flicker emissions
EN 61000-3-3
Complies

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Guidance and manufacturer’s declaration – Immunity Emissions
The surgical aspirator KATASPIR 230/12BR is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator KATASPIR 230/12BR should assure that it’s used in such an environment.
Immunity Test
Level indicated by the
EN 60601-1-2
Compliance Level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC/EN 61000-4-2
± 6kV on contact
± 8kV in air
The device doesn’t
change its state
Floors should be wood, conceret or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
transient / burst
EN 61000-4-4
± 2kV power supply
lines
± 1kV for input /
output lines
The device doesn’t
change its state
Mains power quality should be that of a typical
commercial environment or hospital.
Surge
EN 61000-4-5
± 1kV differential mode
The device doesn’t
change its state
Mains power quality should be that of a typical
commercial environment or hospital.
Loss of voltage, brief
voltage interruptions
and variations
EN 61000-4-11
5%U
T
(>95% dip U
T
) for
0.5 cycle
40%UT(>60% dip UT) for
5 cycle
70%UT(>30% dip UT) for
25 cycle
<5%UT(>95% dip UT) for
5 sec
-
Mains power quality should be that of a typical
commercial environment or hospital If the user of
the surgical aspirator KATASPIR 230/12BR
request that the appliance operates continuously,
the use of a continuity unit is recommended.
Magnetic field
EN 61000-4-8
3A/m
The device doesn’t
change its state
The power frequency magnetic field should be
measured in the intended installation location to
assure that it’s sufficiently low.
Nota UTis the value of the power supply voltage
Guidance and manufacturer’s declaration – Immunity Emissions
The surgical aspirator KATASPIR 230/12BR is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator KATASPIR 230/12BR should assure that it’s used in such an environment.
Immunity Test
Level indicated by
the EN 60601-1-2
Compliance
Level
Electromagnetic environment - guidance
Conducted Immunity
EN 61000-4-6
3Vrms 150kHz to
80Mhz (for non life-
supporting devices)
V
1
= 3 V rms
The portable and mobile RF communication devices,
including cables, must not be used closer to the KATASPIR
230/12BR device, than the separation distance calculated
by the equation applicable to the transmitter frequency.
Recommended separation distance
d = [3.5 / V1]
P
d = [12 / E1]
P
from 80 MHz to 800MHz
d = [23 / E1]
P
from 800 MHz to 2.5 GHz
Where P is the maximum nominal output voltage of the
transmitter in Watt (W) depending on the manufacturer of
the transmitter and the recommended separation distance
in metres (m). The intensity of the field from the fixed RF
transmitters, as determined by an electro-magnetic study
of the sitea), could be lower than the level of conformity of
each frequency interval b). It is possible to check for
interference in proximity to devices identified by the
following symbol:
Radiated Immunity
EN 61000-4-3
3V/m 80MHz to
2.5GHz (for non life-
supporting devices)
E
1
= 3 V / m
Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the absorption and by
reflection from buildings, objects and people.
a) The field intensity for fixed transmitters such as the base stations for radiotelephones (mobile and cordless) and terrestrial mobile
radio, amateur radio devices, radio AM and FM transmitters and TV transmitters can not be theoretically and accurately foreseen. To
establish an electro-magnetic environment generated by fixed RF transmitters, an electro-magnetic study of the site should be
considered. If the field intensity measured in the place where the device will be used surpasses the above mentioned applicable level of
conformity, the normal functioning of the device should be monitored. If abnormal performance arises, additional measures such as
changing the device's direction or positioning may be necessary.
b) The field intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V/m.

GB
12
Recommended separation distance between portable and mobile radio-communication devices and the monitor
The KATASPIR 230/12BR surgical aspirator is intended to operate in an electro-magnetic environment where RF irradiated
interferences are under control. The client or operator of the KATASPIR 230/12BR device can help prevent electro-magnetic
interference by keeping a minimum distance between the portable and mobile RF communication devices (transmitters) and
the KATASPIR 230/12BR device, as recommended below, in relation to the radio-communication maximum output power.
Maximum nominal
output power of the
Transmitter W
Separation distance from the frequency transmitter (m)
150 kHz to 80 MHz
d = [3.5 / V1]
P
80 MHz to 800 MHz
d = [12/E1]
P
800 MHz to 2.5 GHz
d = [23/E1]
P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters with a maximum nominal output power not shown above, the recommended separation distance in metres
(m) can be calculated using the equation applicable to the transmitter frequency, where P is the maximum nominal output
power of the transmitter in Watt (W) depending on the transmitter's manufacturer.
Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the
absorption and by the reflection from buildings, objects and people.
WARRANTY CONDITIONS
This product is guaranteed for a period of 24 months from the date of purchase. The warranty includes the repair or replacement
of defect spare parts free of charge, if the defect has been clearly described by the customer and determined by technical service.
Inspections on the part of the seller, performed at the request of the customer and intended to determined wjether the device is
fully functional, are not covered by the free-of-charge warranty service. This service will be charged to the customer depending on
the effort required. The consumables components are not subject to warranty. Consumable components are silicon tubes, filters,
seals, conical adaptor and suction catheter. Also exluded from warranty is all damage resulting from improper handling, wilful
damage or improper care of the device.
The warranty shall expire if repairs and servicing are not carried out by technical service.
RULES FOR RETURNING AND RAPAIRING
UNDER NEW EUROPEAN RULES, MEDUTEK REQUIRES THE FOLLOWING PROCEDURES TO BE CARRIED OUT TO PROTECT THE
INSTRUMENT AND THE SAFETY OF ALL WHO COME IN CONTACT WITH IT.
Before returning an instrument for repair, the external surfaces and all accessories MUST be carefully disinfected with a cloth
soaked in methylated spirits or hypochlorite-based solution. The instrument and accessories should then be placed in a bag with a
note outlining the disinfection undertaken.
Failure to follow this procedure will result in the instrument being returned to the purchaser unrepaired.
Instruments returned for repair MUST be accompanied by a description of the problem. MEDUTEK will not be responsible for
damage caused through improper use. To avoid such damage, please read the instruction carefully.
Where MEDUTEK determines that an instrument is faulty, a replacement will be provided only if a SALES RECEIPT and STAMPED
GUARANTEE are provided. MEDUTEK will not be responsible for damage accessories. These may be replaced at the customer’s
expence.

13
MEDUTEK
Handelsgesellschaft für Medizintechnik mbH & Co. KG
Stresemannstr. 54
♦
28207 Bremen
Tel.: +49 (0) 421 - 427 48 0 ♦Fax: +49 (0) 421 - 427 48 48
www.medutek.com ♦[email protected]
CA-MI S.r.l
Via Ugo La Malfa N° 13 – Frazione Pilastro
43010 Langhirano (PR) ITALY
30751/692 – Rev. 2 - 28.09.2017