Suction Unit CAMI New Hospivac350 User Manual
Contents
1. SUCTION UNIT NEW HOSPIVAC350 SUCTION UNIT NEW HOSPIVAC400 USER MANUAL CE 0123 medical suction l www medicalsuction co uk NEW HOSPIVAC 400 NEW HOSPIVAC 350 is a surgical aspirator power fed at 230V 50Hz to be used for suctioning body liquids such as mucus phlegm and blood provided with 4 antistatic wheels two of which with braking device and a pulling handle This equipment is designed for easy transport and continuous utilization Thanks to these characteristics and to its functions this device is particularly suitable for utilization in hospital wards and operation theatres both for suctioning body liquids and for gynaecological and dermatological liposuction applications Its provided with a plastic body with thermal and electrical isolation in compliance with European safety standards two complete suction tanks in polycarbonate suitable for sterilization and a float valve besides being fitted with a suction regulator and a vacuum gauge on the front panel Versions fitted with footswitch control and flux deviator are available on request The electronic management system fitted on the front panel allows to perform suction by means of the footswitch control as well as to suction liquids in both tanks provided without having to switch the equipment off to reconnect the second tank GENERAL WARNING READ INSTRUCTION MANUAL CAREFULLY BEFORE USE ONLY HIGHLY QUALIFIED STAFF USE RESERVED THE INST2. At the end of the autotest cycle the ON OFF button led will flash To decide which side to perform the suction from press OUT LEFT or OUT RIGHT and the selected button led will show a blue light Press the ON OFF button again to start the suction cycle If the device is set up for using the flow deviator ensure the antibacterial filter has been positioned on both sides Connect the footswitch control feeding cable with the plug marked as FOOTSWITCH CONTROL Press the button marked as to perform suction using the footswitch control and execute intermittence work cycles Press the button marked as to perform remote suction using the footswitch control continuous suction To stop suction just push on the footswitch control with strength Press the ON OFF button to stop the medical equipment Before removing the feeding plug ensure autotest has been performed on the panel s MADE IN ITALY HOSPIVAC Ka A as A 1 Og SSA xx 80 2055 KPa 5 o g AN Using FLOVAC disposable collection system Before connecting the disposable collection system remove the white ring fitted on the tank holder for a more comfortable insertion of the same container Connect the short tube with the throttle connector marked as VACUUM fitted on the lid of the disposable pocket The container should be positioned on ON The long silicon tube should be connected with the connector marked as PATIENT In order to perform s
3. filter is made of hydrophobic material that stops the passage of liquids into the same filter If you suspect the filter may have been contaminated and or got wet or discoloured always remove and replace the filter If the equipment is to be used on patients with unknown pathological conditions or should you evaluate the possibility of indirect contamination remove and replace the filter after each utilization The filter is not designed for decontamination disassembly and or sterilization If you suspect the filier may have been contaminated and or got wet or discoloured always remove and replace the filter If the equipment is to be used on patients whose pathologies are known and not implying any indirect contamination risks we recommend to remove and replace the filter at the end of each work shift or else every month even if the equipment has not been used 4000cc complete tank versions are available on request Versions fitted with FLOVAC 2000ml or 3000ml disposable collection systems including a re usable rigid polycarbonate container and a disposable Liner are also available on request WARNING Suction tubes for insertion in the human body purchased separately from the machine should comply with ISO 10993 1 standards on material biocompatibility 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 al
4. 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 You can then detach all accessories and perform cleaning operations as described under Cleaning accessories and internal parts below Using the footswitch control Connect the footswitch control feeding cable with the plug marked as FOOTSWITCH CONTROL After the device has been connected all Leds are still off When the ON OFF button is pressed all Leds are activated at once for 1 second autotest At the end of the autotest cycle the ON OFF button led will flash Press the button marked as to perform suction using the footswitch control and execute intermittence work cycles Press the button marked as to perform remote suction using the footswitch control continuous suction To stop suction just push on the footswitch control with strength 8 www medicalsuction co uk 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 collection tanks provided Flow deviator comes with two complete suction kits 2 sets of tubes 2 antibacterial and hydrophobic filters and two conical junctions After the device has been connected all Leds are still off When the ON OFF button is pressed all Leds are activated at once for 1 second autotest
5. RUMENT 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 LOCAL 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 b
6. 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 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
7. e 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 previous use Always check the integrity of the footswitch power cord 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 90 kPa 0 90 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 4A 250V reachable from exterior and it situated in the plug protects the instrument For use replacing always check the type and the range indicated r O EEE i EE M uni doesn t work External power source failure Check the external power source 3 No aspiration Lid seal not in its seat Unscrew the cap and insert the seal properly in its seat The Vacuum Vacuum regulator set to a Turn the vacuum regulator clockwise and pa on the patient dam check the value of the vacuum on the gauge side is either very b Protection filter blocked b Replace the filter low or absent or damaged c Replace or reconnect the tubes check the jar c Connection tubes blocked connections kinked or disconnected d Empty the jar o
8. eriously the safety and the technical characteristics of the same IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC DIRECTIVE 002 96 EC n 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 TYPOLOGY MDD 93 42 EEC Class Ila Medical Decice NEW HOSPIVAC 400 HIGH VACUUM HIGH FLOW 230V 50Hz 300 VA F 1 x4A 250V MAXIMUM SUCTION PRESSURE wit
9. etting in contact with contaminating substances after each utilization cycle of the machine 4 www medicalsuction co uk Guidance and manufacturer s declaration Electromagnetic Emissions The surgical aspirator NEW HOSPIVAC 400 NEW HOSPIVAC 350 is intended for use in the electromagnetic environment specified below The customers or the user of the surgical aspirator NEW HOSPIVAC 400 NEW HOSPIVAC 350 should assure that its used in such an environment Emissions Test Complianc Electromagnetic environment guidance e Power disturbance Group 1 The surgical aspirator NEW HOSPIVAC 400 NEW CISPR11 HOSPIVAC 350 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 The surgical aspirator NEW HOSPIVAC 400 NEW emissions CISPR11 HOSPIVAC 350 can be used in all environments including domestic and those connected directly to the public mains 61000 3 2 distribution that supplies power to environments used for Voltage fluctuations Complies domestic scopes flicker emissions IEC EN 61000 3 3 Guidance and manufacturer s declaration Electromagnetic Immunity The surgical aspirator NEW HOSPIVAC 400 NEW HOSPIVAC 350 is intended for use in the electromagnetic environment specified below The customers or the user of the surgical aspirator NEW HOSPIVAC 400 NEW HOSPIVAC 350 should assure that its used in s
10. fter 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 responsibility 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
11. hout 90kPa 0 90 Bar 90kPa 0 90 Bar jar 675mmHg 675mmHg MAXIMUM SUCTION FLOW without jar 90 l min 60 l min WEIGHT 20 Kg 13 Kg SIZE 460 x 850 h x 420 mm DUTY CYCLE to 35 C and 110 operating Non Stop Operated voltage SICILICONE TUBE SIZE ACCURANCY OF VACUUM INDICATOR WORKING CONDITION Room temperature 55390 Room humidity percentage 30 75 RH Altitude 0 2000m s l m CONSERVATION CONDITION AND Room temperature 40 70 C TRASPORT Room humidity percentage 10 100 RH SYMBOLS Class II isolation equipment CE marking in conformity with EC directive 93 42 EEC and subsequent changes C 01 23 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 Conservation temperature 40 70 C Type B equipment Fuse Alternate Current ON OFF Using the footswitch control for intermittence suction Using the footswitch control for continuous suction 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 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 g
12. n 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 N DO NOT WASH STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER 6 www medicalsuction co uk Instruction for disposal Liner Flovac If the device is equipped with disposable collection systems FLOVAC carry out the disposal of the bag as follows Turn off the Vacuum and remove all the tubes connected to the Liner giving particular attention to avoid accidental contamination Fit the appropriate plugs to the PATIENT and TANDEM ports pressing the home firmly taking care to avoid accidental contamination Turn the butterfly connector to OFF Remove the liner bag from the rigid container and transfer it to the waste disposal area ensuring that all the openings are sealed keeping in mind the product is potentially infectious This product must be disposed of in accordance with the current hospital regulations MAINTENANCE The NEW HOSPIVAC 400 NEW HOSPIVAC 350 suction equipment does not need maintenanc
13. nect the short silicon tube fitted with the antibacterial fi with the Device suction union you may choose either the right or t left union e The other tube by one end connected with the filter shoul 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 fitte The float signals when the maximum level of volume is rea i e 90 of the tank volume has already been used to pre liquid from entering the machine the float closes the lid junction This equipment should only be utilised on an horizuria working surface WARNING Ensure that the IN marker on the filter is on the side facing the collection jar lid and fitted into 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 feeding cable into a power socket Press the ON OFF button to start the medical equipment 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
14. r disconnect the tube from d Shut off valve blocked the jar and unblock the shut off valve The unit or damaged twill only work in the upright position e Pump motor damaged e Refer to authorised service personnel 5 The float doesn t If the cap has been washed Insert the float into it s place close ensure that the float is not partially detached close material autoclave Contact the seller or CA MI After sales 6 7 achieved the desired results Assistance Service If the overfill security system it s activated don t proceed 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 7 www medicalsuction co uk BEFORE EVERY CHECKING OPERATION IN CASE OF ANOMALIES OR BAD FUNCTIONING PLEASE CONTACT CA MI TECHNICAL SERVICE THE MANUFACTURER DOES NOT GIVE GUARANTEE IF INSTRUMENT AFTER THE TECHNICAL SERVICE CHECKING APPEARS TO BE TAMPERED INSTRUCTIONS e Con
15. so 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 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 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 i
16. uch an environment Immunity Test Electromagnetic environments guidance Electrostatic discharge ESD 6kV on contact Floors should be wood concrete or ceramic tile If floors IEC EN 61000 4 2 8kV in air are covered with synthetic material the relative humidity should be at least 30 burst commercial environment or hospital IEC EN 61000 4 4 mode commercial environment or hospital Loss of voltage brief voltage 5 Ur for 0 5 cycle Mains power quality should be that of a typical interruptions and variations 40 Ur for 05 cycle commercial environment or hospital If the user of the IEC EN 61000 4 11 70 Ur for 25 cycle surgical aspirator NEW HOSPIVAC 400 NEW lt 5 Ur for 5 sec HOSPIVAC 350 request that the appliance operates continuously the use of a continuity unit is recommended Magnetic field 3A m The power frequency magnetic field should be IEC EN 61000 4 8 measured in the intended installation location to assure that it s sufficiently low Conducted Immunity 3Vrms 150kHz to IEC EN 61000 4 6 80MHz for appliances that arent life supporting Irradiated Conducted 3V m 80MHz to 2 5 IEC EN 61000 4 3 GHz for appliances that arent life equipment Note Ur is the value of the power supply voltage 5 www medicalsuction co uk ACCESSORIES SUPPLIED ANTIBACTERIAL AND HYDROFOBIC FILTER FOOTSWITCH CONTROL cod 52130 for versions equipped with footswitch control Replacing the antibacterial filter The
17. uction close the connector marked as TANDEM with the lid provided If using the equipment with FLOVAC disposable collection system antibacterial filters are not required since each disposable pocket is already provided with an inside filter The hydrophobic antireflux and antibacterial filter provided will protect the equipment while also acting as float valve deactivating vacuum generation when the maximum volume level is reached When the float valve intervenes signalling the device is too full the suction source must be disconnected within no more than 5 minutes Warning The accidental inversion of connections may cause contamination for the operator and or for the vacuum generation equipment NEVER USE THE DEVICE WITHOUT JAR AND OR PROTECTION FILTER Ze MAKE SURE THAT CHILDREN AND OR D N MENTALLY ILL PEOPLE DO NOT USE THE DEVICE WITHOUT ADULT SURVEILLANCE ALWAYS PLACE THE DEVICE IN POSITIONS FOR a EASY DISCONNECTION 9 www medicalsuction co uk Filter Assembling Mod NEW HOSPIVAC 400 NEW HOSPIVAC 350 FLOW DIRECTION Suction pump Inlet Jar Air Tube 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 a
18. y 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 5 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 witch it has been designed ad 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 s
19. y the manufacturer CA MI Srl to guarantee the highest efficiency and safety of the device e The device can be used only with the bacteriological filter Never immerge the appliance into water e Avoid touching the aspirator with wet hands and always prevent 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 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 N sa R 2 www medicalsuction co uk e Keep off the reach of children or not capable people without supervision e Don t leave the appliance connected to the power supply socket when not in use e Dont pull the power suppl
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