Portable Suction Unit CAMI New Askir30 12V User Manual
Contents
1. SUCTION UNIT NEW ASKIR30 12V USER MANUAL CE 0123 medical suction www medicalsuction co uk NEW ASKIR 30 12V Surgical aspirator is a portable unit working with 12V dc autotration battery designed for the aspiration of bodily fluids in adult and children It s particularly suitable for nasal oral or tracheal aspiration of mucus catarrh or blood after minor surgical procedures and can be used in post operative therapy at home or conveniently transported from one hospital ward to another The device is intended to be powered by a 12V DC car battery with non continuous operation Ton 20 min Toff 40 min 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 GENERAL WARNING A READ INSTRUCTION MANUAL CAREFULLY BEFORE USE THE DEVICE IS FOR USE BY QUALIFIED PERSONNEL SURGEON PROFESSIONAL NURSE ASSISTANT THE INSTRUMENT MUST NOT DISASSEMBLED FOR TECHNICAL SERVICE ALWAYS CONTACT CA MI SRL 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 elec2. t appear to be necessary Unpack the instrument and always check integrity of plastic parts and feeding cable they might have been damaged during previous use Connect the cable to electrical network and turn the switch on Close the aspirator outlet with your finger and with suction regulator at maximum check that the vacuum indicators reaches at least 75kPa 0 75 bar Rotate the knob from right to left The vacuum indicator should go down 25kPa 0 25 bar Check that no loud noises are present The device is protected by a safety fuse F 10A L 250V situated in the cigarette lighter adapter For fuses replacing always the type and the range Before changing the fuse disconnect the plug from the power supply socket Cause Y O et pe The suction unit doesn t work Cable is damaged SSS ae tot o the cable External power source failure Check the external power source 2 No aspiration Jar Cap badly screwed down Unscrewed the cap then rescrew it correctl 3 No aspiration Lid seal not in its seat Unscrew the cap and insert the seal properly in its seat 4 The Vacuum power on the a Vacuum regulator set to minimum a Turn the vacuum regulator clockwise and check the patient side is either very low b Protection filter blocked or value of the vacuum on the gauge or absent damaged b Replace the filter c Connection tubes blocked kinked c Replace or reconnect the tubes check the jar or disconnected connections d Shut off valve blocke
3. www medicalsuction co uk Guidance and manufacturer s declaration Electromagnetic Emissions The surgical aspirator NEW ASKIR 30 12V is intended for use in the electromagnetic environment specified below Emissions Test Compliance Electromagnetic environment guidance Irradiated Conducted emissions Group 1 The surgical aspirator NEW ASKIR 30 12V CISPR11 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 Class B The surgical aspirator NEW ASKIR 30 12V CISPR11 can be used in all Harmonic emissions IEC EN 61000 3 2 Class A environments including domestic and Voltage fluctuations flicker emissions Complies those connected directly to the IEC EN 61000 3 3 public mains distribution that supplies power to environments used for domestic scopes Guidance and manufacturer s declaration Electromagnetic Immunity The surgical aspirator NEW ASPIRET is intended for use in the electromagnetic environment specified below The customers or the user of the surgical aspirator NEW ASPIRET should assure that it s used in such an environment Immunity Test Compliance Electromagnetic environments guidance Electrostatic discharge ESD 6kV on contact Floors should be wood concrete or ceramic IEC EN 61000 4 2 8kV in air tile If floors are covered with synthetic material the rel
4. 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 in the cover under VACUUM connector 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 anew employment now DO NOT WASH STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER A www medicalsuction co uk MAINTENANCE The NEW ASKIR 30 12V suction equipment does not need maintenance or lubrication It is however necessary to inspect the unit before each use With regard to training given the information contained in the user manual and since it is easy to understand the said device it doesn
5. CE WITHOUT ADULT SURVEILLANCE ALWAYS PLACE THE DEVICE IN POSITIONS FOR EASY DISCONNECTION 6 www medicalsuction co uk RULES FOR RETURNING AND REPAIRING UNDER NEW EUROPEAN RULES CA MI REQUIRES THE FOLLOWING PROCEDURES TO BE CARRIED OUT TO PROTECT THE INSTRUMENT AND THE SAFETY OF ALL WHO COME IN CONTACT WITH IT CA MI warrants it s product for 24 months after purchasing date 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 CA MI will not be responsible for damage caused through improper use To avoid such damage please read the instruction carefully Where CA MI determines that an instrument is faulty a replacement will be provided only ifa SALES RECEIPT and STAMPED GUARANTEE are provided CA MI will not be responsible for damage accessories These may be replaced at the customer s expense 7 www medicalsuction co uk
6. G PLEASE CONTACT CA MI TECHNICAL SERVICE THE MANUFACTURER DOES NOT GIVE GUARANTEE IF INSTRUMENT AFTER THE TECHNICAL SERVICE CHECKING APPEARS TO BE TAMPERED INSTRUCTIONS 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 Place the unit on a flat horizontal surface Connect one end of the short silicon tube with antibacterial filter to the suction connector on the lid of the jar The other tube already connected to the filter has to be connected to the VACUUM jar outlet where has been fixed the red float security 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 5 www medicalsuction co uk 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 conn
7. ative humidity should be at least 30 Electrical fast transient burst 2kV power supply Mains power quality should be that of a IEC EN 61000 4 4 typical commercial environment or hospital Surge 1kV differential mode Mains power quality should be that of a IEC EN 61000 4 5 typical commercial environment or hospital Loss of voltage brief voltage interruptions 5 Ur for 0 5 cycle Mains power quality should be that of a and variations 40 Ur for 05 cycle typical commercial environment or hospital IEC EN 61000 4 1 1 70 Ur for 25 cycle If lt 5 Ur the user of the surgical aspirator NEW for 5 sec ASPIRET request that the appliance operates continuously the use of a continuity unit is recommended Magnetic field 3A m The power frequency magnetic field should IEC EN 61000 4 8 be measured in the intended installation location to assure that it s sufficiently low eee amine ema OOOO oO IEC EN 61000 4 6 for appliances that aren t life supporting IEC EN 61000 4 3 for appliances that aren t life equipment Note Ur is the value of the power supply voltage 3 www medicalsuction co uk ACCESSORIES SUPPLIED DESCRIPTION COMPLETE ASPIRATION JAR 1000cc CONICAL FITTING TUBES SET 6 mm x 10 mm ASPIRATION PROBE CH20 ANTIBACTERIAL FILTER Antibacterial Filter The filter is produced with PTFE hydrophobic material witch prevents fluids entering the pneumatic circuit The filter is for a single patient use which will pr
8. d or d Empty the jar or disconnect the tube from the jar and damaged unblock the shut off valve The unit twill only work in the e Pump motor damaged upright position e Refer to authorised service personnel 5 The float doesn t close If the cap has been washed ensure Insert the float into it s Daca slack ac that the float is not partially detached 6 The float doesn t close The float it s covered by dirty Ichi anc the cap leave the and put in on autoclave material Foam inside the jar Fill the jar to 1 3 full of ordinary water Faults 1 2 3 4 5 6 7 None of the remedies has Contact the seller or CA MI After sales Assistance achieved the desired results Service 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 FUNCTIONIN
9. e 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 its 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 TECHNICAL CHARACTERISTICS MAIN VOLTAGE 12V dc SICILICONE TUBE SIZE 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 Warning consult the instruction manual Conservation temperature 40 70 C Type B equipment DEHP Phthalates Suction catheter Alternate Current ON 2
10. ection causes immediate destruction in case of contact with sucked liquids Filter assembling FLOW DIRECTION IN Fluid Inside Suction Pump Inlet Jar Air Tube Connect the long silicone tube to the PATIENT jar outlet Connect the other end of the long silicon tube to the probe plastic connector then connect the suction probe to it Connect the power cord to the device then connect the plug to the electrical mains supply Push switch on position I to start suction 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 functionality vacuum then rescrew the lid on the jar correctly During operation the jar has to be in vertical position to avoid overflow valve to cut off aspiration Should this happen switch off the device and disconnect the tube from the jar cover from VACUUM outlet Once finished push switch on O position and unplug Remove the accessories and clean WARNING The on off button used as a network switch is the element that separates the mains in any case even if the device is equipped with a specific on off button the 12V power plug must remain accessible once the device is in use to allow for an additional method to simultaneously disconnect all the poles from the mains NEVER USE THE DEVICE WITHOUT JAR AND OR PROTECTION FILTER MAKE SURE THAT CHILDREN AND OR MENTALLY ILL PEOPLE DO NOT USE THE DEVI
11. mental conditions different than those indicated in this manual may harm seriously 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 supplied with the device furnished with the relative CE compliance certification according to the requirements of regulation ISO 10993 1 thus no allergic reactions and skin irritations may occur 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 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 1 www medicalsuction co uk Z 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 garbag
12. ng 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 850 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 To clean the plastic housing of the device wear disposable latex gloves and clean with denaturated alcohol or hypoclorite solutions Washing and or cleaning the autoclavable jar as to be carried out as follows e Wear protection gloves and apron glasses and face mask if necessary to avoid contact with contaminating substances Disconnect the jar from the device Disconnect all tubes from the jar and the protection filter Empty and dispose of the content and of the suction catheter according to the laws in force in your country Separate all parts of the cover overflow valve o ring 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
13. otect patients and machines from cross contamination When the filter is wet it s not possible to use the unit therefore the filter should be changed immediately In case of possible contamination or discolouration change the filter immediately Don t use the suction unit without the protection filter fitted 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 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 cleani
14. 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 Don t use the device thoracic drainage 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 NEW ASKIR 30 12V 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 T 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 CA MI Srl 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 environ
15. tric 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 si 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 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 CA MI 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
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