Suction Unit CAMI New Aspiret User Manual
Contents
1. SUCTION UNIT NEW ASPIRET USER MANUAL CE 0123 www medicalsuction co uk NEW ASPIRET Surgical Aspirator is a portable unit working with 230V 50 Hz network electricity 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 Easily portable equipment designed for continuous use It s made of highly heat resistant electrically insulated plastic material that conforms with the latest European safety Standards New Aspiret comes equipped with an aspiration regulator on the front panel and a polycarbonate autoclavable jar complete with overflow valve GENERAL WARNING A A A 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 IMPORTANT SAFETY RULES 1 2 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 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 pl2. equipment Note Ur is the value of the power supply voltage ACCESSORIES SUPPLIED DESCRIPTION COMPLETE ASPIRATION JAR 1000cc CONICAL FITTING TUBES SET 6 mm x 10 mm ASPIRATION PROBE CH20 ANTIBACTERIAL FILTER Available under request with different versions with complete jar 2000cc 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 protect 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 A www medicalsuction co uk 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 a
3. distance from heat sources e Don t use the device thoracic drainage 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 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 will not be responsible for damage due to improper use or connection to an electrical system not complying with current regulations Particular precautions must be made concerning electromagnetic compatibility The medical device must be installed and used according to information supplied with the accompanying documents Instrument and accessories discharging must be done following current law regulations in every country of use 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 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 1 www medicalsuction co uk et IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC DIRECTIVE 2002 96 EC In respect of art 13 Decreto Legislativo 25 Lugli
4. 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 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 e
5. PLEASE CONTACT CA MI TECHNICAL SERVICE THE MANUFACTURER DOES NOT GIVE GUARANTEE IF INSTRUMENT AFTER THE TECHNICAL SERVICE CHECKING APPEARS TO BE TAMPERED 6 www medicalsuction co uk INSTRUCTIONS e Place the unit on a flat horizontal surface e Connect the end of the short silicon tube with antibacterial filter to the suction connector e 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 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 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 e During operation the jar ha
6. cified 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 IEC EN 61000 4 2 8kV in air ceramic tile If floors are covered with synthetic material the relative 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 5 Ur for 0 5 cycle Mains power quality should be that of a interruptions and variations 40 Ur for 05 cycle typical commercial environment or IEC EN 61000 4 11 70 Ur for 25 cycle hospital If lt 5 UtT 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 IEC EN 61000 4 8 should be measured in the intended installation location to assure that it s sufficiently low Conducted Immunity 3Vrms 150kHz to 80MHz IEC EN 61000 4 6 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
7. en rescrew it correctly 5 No aspiration Lid seal not in its seat Unscrew the cap and insert the seal properly in its seat The Vacuum power a Vacuum regulator set to a Turn the vacuum regulator clockwise and check the on the patient side is either minimum value of the vacuum on the gauge very low or absent b Protection filter blocked or b Replace the filter 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 jar d Shut off valve blocked or and unblock the shut off valve The unit twill only damaged work in the upright position e Pump motor damaged e Refer to authorised service personnel 5 The float doesn t close If the cap has been washed Insert the float into it s place ensure that the float is not partially detached 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 fails continued aspiration will be stopped by the bacteriological filter Should this back up security also fail there is a risk of penetration of liquid into the device Don t attempt to proceed with aspiration under these circumstances Return the device to CA MI for service ZN BEFORE EVERY CHECKING OPERATION IN CASE OF ANOMALIES OR BAD FUNCTIONING
8. ncountered 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 8 www medicalsuction co uk
9. nd 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 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 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 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 Place the o ring in
10. o 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 TECHNICAL CHARACTERISTICS MAXIMUM SUCTION PRESSURE without jar 75kPa 0 75 Bar from 75kPa 0 75bar to 10kPa 0 10 bar MAXIMUM SUCTION FLOW without jar 15 U min WORKING CONDITION Room temperature 5 35 C Room humidity percentage 30 75 RH Altitude 0 2000m s l m Room humidity percentage 10 100 RH 2 www medicalsuction co uk SYMBOLS Class Il isolation equipment CE marking in conf
11. ormity with EC directive 93 42 EEC and subsequent changes Warning consult the instruction manual Keep in a cool dry place Conservation temperature 40 70 C Type B equipment DEHP Phthalates Suction catheter Please note technical specifications may vary upon the manufacturer s discretion Guidance and manufacturer s declaration Electromagnetic Emissions 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 Emissions Test Compliance Electromagnetic environment guidance Power disturbance Group 1 The surgical aspirator NEW ASPIRET only CISPR11 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 to ee Conducted emissions Class a ae surgical aspirator NEW ASPIRET can a usted emissions in all environments including Voltage fluctuations flicker emissions Complies domestic IEC EN 61000 3 3 and those connected directly to the public mains distribution that supplies power to environments used for domestic scopes 3 www medicalsuction co uk Guidance and manufacturer s declaration Electromagnetic Immunity The surgical aspirator NEW ASPIRET is intended for use in the electromagnetic environment spe
12. s 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 e Once finished push switch on O position and unplug e Remove the accessories and clean NEVER USE THE DEVICE WITHOUT JAR AND OR PROTECTION FILTER MAKE SURE THAT CHILDREN AND OR MENTALLY ILL PEOPLE DO NOT USE THE DEVICE WITHOUT ADULT SURVEILLANCE ALWAYS PLACE THE DEVICE IN POSITIONS FOR EASY DISCONNECTION 7 www medicalsuction co uk Filter Assembling Mod NEW ASPIRET FLOW DIRECTION S AR9oae_ IN Fluid Inside 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 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
13. to its seat around the cover 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 A DO NOT WASH STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER 5 www medicalsuction co uk MAINTENANCE The NEW ASPIRET suction equipment does not need maintenance or lubrication It is however necessary to inspect the unit before each use Unpack the instrument and always check the plastic parts for any damage that may have occurred during prior use Connect cable to electrical network and turn switch on Close the aspiration outlet with your finger and with suction regulator at maximum check that the vacuum position reaches at least 75 kPa 0 75 bar maximum Rotate the knob from right to left and check the aspiration regulating control The vacuum indicator should go down to 25 kPa 0 25 bar Check that no loud noises are present A fuse F 1x1 6A 250V is located in the plug to protect the instrument If required replace with another or the correct type Fault type 1 The suction unit Cable is damaged Replace the cable doesn t work External power source failure Check the external power source Jar Cap badly screwed down Unscrewed the cap th
14. ug 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 The device can be used only with the bacteriological filter Never immerge the appliance into water Place instrument on stable and flat surfaces Position the device in a way that the air inlets on the back aren t obstructed 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 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 Don t pull the power supply cable to disconnect the plug remove the plug from the mains socket correctly Preserve and use the medical device in environments protected from atmospheric factors and at a
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