Suction Units CAMI New AskirC30 User Manual
Contents
1. SUCTION UNIT NEW ASKIR C30 USER MANUAL CE 0123 medical suction 1 www medicalsuction co uk NEW ASKIR C30 it s an electrical powered surgical aspirator used for the nasal oral and tracheal suction in man and child of body liquids mucus catarrh or blood The unit is equipped with a trolley provided with 5 wheels three of them are provided with locking system in order to avoid the equipment can overbalance and an external plastic enclosure Thanks to this characteristics and to the rating that it has this product is particularly suitable for hospital use on the tracheotomized patients minor surgical applications and post operative therapy at home Made of highly heat resistant electrically insulated plastic material in conformity with the latest European safety standard the product is supplied with a complete polycarbonate autoclavable jar with overflow valve and it is equipped with aspiration regulator and vacuum indicator located on the front panel Available under request with different version for application and use version with remote control etc GENERAL WARNING READ INSTRUCTION MANUAL CAREFULLY BEFORE USE ONLY HIGHLY QUALIFIED STAFF USE RESERVED THE INSTRUMENT MUST NOT BE DISASSEMBLED FOR A TECHNICAL SERVICE ALWAYS CONTACT CA MI KEEP OFF THE REACH OF CHILDREN OR NOT CAPABLE PEOPLE WITHOUT SUPERVISION FULL CONTAINERS MUST BE HANDLED WITH GREAT CARE DURING TRANSFER TO THE DISPOSAL AREAS FOLLOWING THE L2. For repairs exclusively contact CA MI technical service and request the use of original spare parts Failure to comply with the above can jeopardise the safety of the device 6 This medical device must be destined exclusively for the use for which it has been designed and described in this manual Any different use must be considered incorrect and therefore dangerous the manufacturer cannot be considered liable for damage caused by improper incorrect and or unreasonable use or if the appliance is used in electrical plants that are not in compliance with the regulations in force 7 Particular precautions must be made concerning electromagnetic compatibility The medical device must be installed and used according to information supplied with the accompanying documents 8 Instrument and accessories discharging must be done following current law regulations in every country of use 9 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 CA MI technical assistance 10 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 CA MI Srl 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 acciden
3. A m The power frequency magnetic field should be IEC EN 61000 4 8 measured in the intended installation location to meN assure that it s sufficiently low Conducted Immunity 3Vrms 150kHz to 80MHz for appliances that aren t life supporting Irradiated Conducted 3V m 80MHz to 2 5 GHz IEC EN 61000 4 3 for appliances that aren t life equipment Note Ur is the value of the power supply voltage 5 www medicalsuction co uk ACCESSORIES SUPPLIED ANTIBACTERIAL AND HYDROFOBIC FILTER SUCTION PROBE CH20 FOOTSWITCH CONTROL cod 52130 for versions equipped with footswitch control 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 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 CLEANING THE MAIN UNIT To clean the device external parts always use a cotton cloth dampened with detergent Don t use abrasive or solvent detergents PAR
4. MUM SUCTION FLOW without jar DUTY CYCLE to 35 C and 110 operating 120 ON 60 OFF voltage SICILICONE TUBE SIZE 8x 14mm ACCURANCY OF VACUUM INDICATOR WORKING CONDITION Room temperature 5 35 C Room humidity percentage 30 75 RH Altitude 0 2000m s l m CONSERVATION CONDITION AND TRASPORT Room temperature 40 70 C Room humidity percentage 10 100 RH SYMBOLS Class II isolation equipment CE marking in conformity with EC directive 93 42 EEC and subsequent changes CE 0123 Manufactured by CA MI Srl Via Ugo La Malfa nr 31 43010 Pilastro PR Italia Warning consult the instruction manual To Preserve in place coolness and dry land Type B equipment Alternate Current Mains Frequency Remote Control DEHP Phthalates Suction catheter Please note technical specifications may vary upon the manufacturer s discretion A www medicalsuction co uk Guidance and manufacturer s declaration Electromagnetic Emissions The surgical aspirator NEW ASKIR C30 is intended for use in the electromagnetic environment specified below The customers or the user of the surgical aspirator NEW ASKIR C30 should assure that it s used in such an environment Power disturbance The surgical aspirator NEW ASKIR C30 only used RF energy CISPR11 only for its internal functioning Therefore its RF emissions are very low and are not cause interference in proximity of any Electronic appliances The surgical a
5. OCAL PROCEDURES AND REGULATIONS IMPORTANT SAFETY RULES On opening the packaging check the integrity of the appliance paying particular attention to the presence of damage to the plastic parts which may make access possible to internal live parts and also to breakage and or peeling of the power supply cable In these cases don t connect the plug to the electric socket Carry out these controls before each use 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 If the plug supplied with the appliance is incompatible with the mains electricity socket contact qualified staff for replacement of the plug with a suitable type The use of simple or multiple and or extension adapters is not generally recommended Whenever their use is indispensable use those in compliance with safety regulations however paying attention not to exceed the maximum power supply limits which are indicated on the adapters and extensions Respect the safety regulations indicated for electrical appliances and particularly e Use original components and accessories provided by the manufacturer CA MI to guarantee the highest efficiency and safety of the device e The device can be used only with the bacteriological filter Never immerse the appliance into water e Avoid touching the aspirator with wet hands and always prev
6. TICULAR CARE SHOULD BE TAKEN TO ENSURE THAT THE INTERNAL PARTS OF THE A N 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 CLEANING ACCESSORIES AND INTERNAL PARTS At the end of the application switch the equipment off and clean all its accessories as follows e Wear protection gloves and apron if need be also wear a face mask and glasses to avoid getting in contact with contaminating substances e Disconnect the tank from the equipment removing any tubes connected to the container and paying particular attention to avoiding accidental contaminations e Empty and dispose of the flacon content complying with hospital regulations as well as with any provisions in force including local regulations e Separate all the parts of the lid float device and rings After disposing of disposable parts and disassembling the jar wash in running cold water and rinse thoroughly Then soak in warm water temperature shall not exceed 60 C Wash thoroughly 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
7. 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 10 www medicalsuction co uk
8. device NEW ASKIR C30 Take the 5 arm base and set up the 5 wheels that come with the above device The wheels provided with braking device must be placed one next to the order Take the support bar that comes with the device NEW ASKIR C30 and place it in the hole on the 5 arm base From under the base lock the two parts by means of the supplied screw Eventually place the device on the trolley e Connect the short silicon tube fitted with the antibacterial filter with the device suction union you may choose either the right or the left union e The other tube by one end connected with the filter should instead be connected with the union on the tank lid marked as VACUUM in which the float signalling when the device is too full is fitted The float signals when the maximum level of volume is reached i e 90 of the tank volume has already been used to prevent liquid from entering the machine the float closes the lid junction This equipment should only be utilised on an horizontal working surface WARNING Ensure that the IN marker on the filter is on the side facing the collection jar lid and fitted into A N the VACUUM A wrong connection causes immediate destruction in case of contact with sucked liquids Connect the long silicon tube with the lid union still free and marked as PATIENT Connect the conical junction for probe insertion with the free end of the long silicon tube Insert the plug of the equipment feed
9. ent the equipment from getting in touch with liquids Never leave the equipment near water or immerse it into a liquid Should the equipment fall into water detach its power cable from the socket before touching it e None of the electrical and or mechanical parts of the machine is designed to be repaired by the client and or by its user Do not open the aspirator or disassembly its electrical and or mechanical parts Always report to CA MI Srl technical support e Using the equipment in environmental conditions other than those indicated in this manual may seriously endanger its safety and technical parameters e Position the appliance on flat stable surfaces Position the device in a way that the air inlets on the back aren t obstructed e Never use the device in environments which have anaesthetic mixtures inflammable with air oxygen or nitric oxide e Don t touch the device with wet hands and always prevent the appliance coming into contact with liquids e Keep off the reach of children or not capable people without supervision Don t leave the appliance connected to the power supply socket when not in use e Don t pull the power supply cable to disconnect the plug remove the plug from the mains socket correctly e Preserve and use the medical device in environments protected from atmospheric factors and at a distance from heat sources e Don t use the device thoracic drainage N a 2 www medicalsuction co uk 5
10. ing cable into a power socket Press the ON OFF button to start the medical equipment e To deal with foam formation within the tank unscrew the tank lid and fill 1 3 of the tank with water to make cleaning easier and speed up depression while operating the equipment place the lid on the jar e While using the equipment the suction tank should always be used vertically to avoid the intervention of the antireflux valve In case of intervention of this protection switch the device off and disconnect the tube connected with the suction tank the one marked as VACUUM on the same lid e Press the ON OFF e You can then detach all accessories and perform cleaning operations as described under Cleaning accessories and internal parts below Footswitch control device The equipment on request is provided with a footswich control device It allows the continuous use of the surgical aspirator In this case the plug of the footswitch device shall be inserted into the appropriate socket outlet placed on the back side of the equipment 9 www medicalsuction co uk Close to this socket a white switch is placed This switch shall be pushed on the position Il so start and stop of the suction operation can be obtained by pressing and releasing the foot swithc control device Using the footswitch control and the flow deviator If using equipment fitted with a flow deviator users may direct suctioned liquids in any of the two collectio
11. ity of CA MI for damages caused by the transport or dismay from the vector Every returned instrument will be hygienically checked before repairing If CA MI finds instrument not suitable for repairing due to clear signs of internal or external contamination the same will be returned to customer with specification of NOT REPAIRED INSTRUMENT accompanied by an explanation letter CA MI will decide if contamination is due to bad functioning or misuse If contamination is due to bad functioning CA MI will substitute the instrument only if a SALE RECEIPT and STAMPED GUARANTEE accompany the same CA MI is not responsible for contaminated accessories they will be substitute at customer s expenses For this reason it is COMPULSORY to carefully disinfect the external part of the instrument and accessories with a cloth soaked in methylated spirits or hypochlorite based solutions Put the instrument and accessories in a bag with indication of disinfecting We also request to specify the kind of fault in order to speed up repairing procedures To this end please read the instructions carefully in order to avoid damaging the equipment through improper use Always specify the fault encountered so that CA MI can establish whether it falls into the category of the faults covered by the guarantee CA MI Srl cannot be held liable for accidental or indirect damages should the device be modified repaired without authorization or should any of its component be
12. n tanks provided Flow deviator comes with two complete suction kits 2 sets of tubes 2 antibacterial and hydrophobic filters and two conical junctions NEVER USE THE DEVICE WITHOUT JAR AND OR PROTECTION FILTER MAKE SURE THAT CHILDREN AND OR MENTALLY ILL PEOPLE DO NOT USE THE DEVICE A N WITHOUT ADULT SURVEILLANCE ALWAYS PLACE THE DEVICE IN POSITIONS FOR EASY DISCONNECTION RULES FOR RETURNING AND REPAIRING COMPLYING WITH THE NEW EUROPEAN RULES CA MI INDICATES THE IMPORTANT POINTS TO PROTECT INSTRUMENT AND OPERATORS HYGIENE THESE RULES MUST BE RESPECTED IN ORDER TO GUARANTEE HYGIENE AND SAFETY TO ALL THE PEOPLE OPERATING WITH THE INSTRUMENT TO OBTAIN QUALITY AND WELL BEING CA MI warrants it s products for 24 months after purchasing date In front of this warranty CA MI will be obliged only to repair or substitute free of charge the products or parts of them that after verification effected on our factory or our authorized Service Center by the Technical Service results defective The product must be accompanied by a description of the defect The warranty with exclusion of responsibility for direct and indirect damages it is thought limited to the solos defects of material or workmanship and it stops having effect when the device results however gotten off tampered or sheltered out of the Factory or from the Authorized Service center The commodity always travels to risk and danger of the buyer without any responsibil
13. position Pump motor Refer to authorised service personnel damaged close ensure that the float is not partially detached close material Foam inside the jar Fill the jar to 1 3 full of ordinary water Faults 1 2 3 4 5 None of the remedies has Contact the seller or CA MI After sales Assistance 6 7 achieved the desired Service results 7 www medicalsuction co uk 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 CA MI technical service CA MI Srl 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 N PLEASE CONTACT CA MI TECHNICAL SERVICE CA MI DOES NOT GIVE GUARANTEE IF INSTRUMENT AFTER THE TECHNICAL SERVICE CHECKING APPEARS TO BE TAMPERED Filter Assembling Mod NEW ASKIR C30 FLOW DIRECTION Suction pump Inlet Jar Air Tube 8 www medicalsuction co uk INSTRUCTIONS Assembly of the
14. revious use Connect cable to electrical network and turn switch on Close the aspiration outlet with your finger and with suction regulator in maximum vacuum position check that the vacuum indicators reaches 80 kPa 0 80 bar maximum Rotate the knob from right to left and check the aspiration regulating control The vacuum indicator should go down 40 kPa 0 40 bar Verify that loud noises are not present these can indicate wrong functioning A protection fuse F 1 x 1 6A 250V reachable from exterior and it situated in the plug protects the instrument For use replacing always check the type and the range indicated Cause Fault ype __ suction Cable is damaged SS ae S the cable a doesn t work External power source failure Check the external power source Jar Cap badly screwed down Unscrewed the cap then rescrew it correct Lid seal not in its seat Unscrew the cap and insert the seal properly in its seat 4 The Vacuum Vacuum regulator set a Turn the vacuum regulator clockwise and power on the patient to minimum check the value of the vacuum on the gauge side is either very Protection filter b Replace the filter low or absent blocked or damaged c Replace or reconnect the tubes check the jar c Connection tubes blocked connections kinked or disconnected d Empty the jar or disconnect the tube from the d Shut off valve jar and unblock the shut off valve The unit twill only blocked or damaged Pa in the upright
15. spirator NEW ASKIR C30 can be used in all emissions CISPR11 environments including domestic and those connected directly to the public mains distribution that supplies power to 61000 3 2 environments used for domestic scopes Voltage fluctuations flicker Complies emissions IEC EN 61000 3 3 Guidance and manufacturer s declaration Electromagnetic Immunity The surgical aspirator NEW ASKIR C30 is intended for use in the electromagnetic environment specified below The customers or the user of the surgical aspirator NEW ASKIR C30 should assure that it s used in such an environment Immunity Test Electromagnetic environments guidance Electrostatic discharge 6kV on contact Floors should be wood concrete or ceramic tile If ESD floors are covered with synthetic material the IEC EN 61000 4 2 relative humidity should be at least 30 Electrical fast transient 2kV power supply Mains power quality should be that of a typical burst commercial environment or hospital IEC EN 61000 4 4 IEC EN 61000 4 5 commercial environment or hospital Loss of voltage brief 9 Ur for 0 5 cycle Mains power quality should be that of a typical voltage interruptions and 40 Ur for 05 cycle commercial environment or hospital If the user of variations 70 U for 25 cycle the surgical aspirator IEC EN 61000 4 1 1 lt 5 Ur for 5 sec NEW ASKIR C30 request that the appliance operates continuously the use of a continuity unit is recommended Magnetic field 3
16. stem cycle at 121 C 1 bar relative pressure making sure that the jar is positioned upside down 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 6 www medicalsuction co uk After sterilization and cooling at environment temperature of the parts make sure that these are not damaged Assemble the jar as follows e Place the overflow valve into its seat in the cover under VACUUM connector e Insert floating valve keeping the o ring towards the opening of the cage e Place the o ring into its seat around the cover e After completing assembling operations always make sue that cover seals perfectly to avoid vacuum leakages or liquid exit The aspiration tubes can be sterilized on autoclave using a sterilization cycle at 120 C The conical connector can be sterilized on autoclave using a sterilization cycle at 121 C The device is ready for a new employment now DO NOT WASH STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER MAINTENANCE The NEW ASKIR C30 suction equipment does not need maintenance or lubrication It is necessary to check functioning and instrument before every use Unpack the instrument and always check integrity of plastic parts and feeding cable they might have been damaged during p
17. t 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 Directive and its normatives pe IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC DIRECTIVE 2002 96 EC In respect of art 13 Decreto Legislativo 25 Luglio 2005 n 151 Actuation of European directives 2002 95 EC 2002 96 EC and 2003 108 EC for reduction in use of dangerous substances in the electric and electronic device and for garbage disposal The symbol as over applied on the device or its packaging means that at the end of its useful life the product must not be disposed of with domestic waste At the end of device useful the user will must deliver it to the able collecting centres for electric and electronic garbage or give back to the retailer in the moment of equivalent new device purchasing one against one Disposing of the product separately prevents possible negative consequences for the environment and for health deriving from inadequate disposal It also allows the recovery of materials of witch it s made up in order to obtain an important saving of energy and resources and to avoid negative effects to the ambient and health In case of abusive disposal of device by user will be applied administrative endorsements in compliance with current standard 3 www medicalsuction co uk TECHNICAL CHARACTERISTICS MAXI
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