User Manual - Novamedica
Contents
1. F O cunEB CON MOTORE A PISTONE WITH PISTON COMPRESSOR AVEC MOTOR A PISTON CON MOTOR DE PISTON MIT KOLBENMOTOR vw B lO es N Grm MANUALE D USO USER MANUAL MODE D EMPLOI HANDBUCH MANUAL DE ISTRUCCIONES 0123 30751 037 Revisione 0 del 17 03 2008 CA MI di Attolini Mario amp C snc Via Ugo La Malfa N 31 43010 Pilastro PR Italia Tel 39 0521 637133 631138 Fax 39 0521 639041 E mail vendite ca mi it export ca mi it CLINEB is a piston type compressor nebulizer system working at 230V 50Hz other voltages available upon request High performance with any type of drug ideal for intensive hospital and clinic use Manufactured with high thermal and electric insulation plastic chassis in compliance with the latest European Safety regulations The oil free piston compressor has long durability and is equipped with the highly efficient HI FLO jet nebulizer to guarantee quick and accurate drug delivery The device is designed for easy transport and halding and is recommended for atomising antibiotics and bronchodilator drugs The medical device is designed for continuous use GENERAL WARNING N READ INSTRUCTION MANUAL CAREFULLY BEFORE USE N DRUG ADMINISTRATION MUST BE UNDER MEDICAL CONTROL N THE INSTRUMENT MUST NOT BE DISASSEMBLED FOR A TECHNICAL SERVICE ALWAYS CONTACT CA MI IMPORTANT SAFETY RULES 1 On opening the packaging check the integrity of the appliance paying particular attent2. position I b Thermal protector may be on the device has b Switch off the device by pressing the switch to been working beyond its limits and or near position 0 and left the motor cool down for at least 30 heat sources minutes 2 Low Nebulization Clogged Nebulizer Tank Clean and disinfect the nebulizer tank as explained in the instruction manual 3 Low Nebulization Clogged Nebulizer Tank If cleaning was not succesful change cruet 4 Absence of Nebulization Clogged Nebulizer Tank a Check that the nebulizer contains medication Make sure that the nebulizer is not clogged Air tube is bended or squeezed Check the connection between the compressor air outlet port and the accessories b Make sure the air tube is not bended or squeezed 5 Slow Nebulization Highly dense drug Dilute drug in physiological liquid 6 Noisy Device Extended use Call retainer or manufacturer CA MI Fault 1 2 3 4 5 6 No solution with previous items Call retainer or manufacturer CA MI if the unit does not nebulizer once the above conditions have been checked we suggest to contact your dealer or technical service CA MI CA MI snc will provide upon request electric diagrams component list descriptions setting instructions and any other information that can help the technical assistance staff for product repair N BEFORE EVERY CHECKING OPERATION IN CASE OF ANOMALIES OR BAD FUNCTIONING PLEASE CONTACT CA MI TECHNICAL SERVICE CA MI DOES NOT GIVE GUARANTE
3. B aerosol should assure that it s used in such an environment Irradiated Conducted emissions CISPR11 Group 1 The CLINEB aerosol 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 Harmonic emissions Class A The CLINEB aerosol can be used in all IEC EN 61000 3 2 environments including domestic and Voltage fluctuations Complies those connected directly to the public mains flicker emissions distribution that supplies power IEC EN 61000 3 3 to environments used for domestic scopes Guidance and manufacturer s declaration Electromagnetic Emissions The CLINEB aerosol is intended for use in the electromagnetic environment specified below The customers or the user of the CLINEB aerosol should assure that it s used in such an environment Immunity Test Electromagnetic environments guidance Electrostatic discharge ESD 6kV on contact Floors should be wood conceret or IEC EN 61000 4 2 8kV in air ceramic tile If floors are coverei 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 a typical commercial environment or hospital Loss of voltage brief
4. E IF INSTRUMENT AFTER THE TECHNICL SERVICE CHECKING APPEARS TO BE TAMPERED 1 Air Tube 2 Nebulizer Tank 3 Nebulization Nozzle 4 Nebulizer Top 5 Mouthpiece 6 Adult Mask 7 Pediatric Mask 8 Nosepiece accessory under request
5. N FOR USE Place the device on a flat stable and clean surface and plug it in the wall socket Make sure the power cord id thouroughly unrolled to avoid dangerous overheating In case the power cord is damaged contact CA MI technical assistance for replacement e Prepare the HI FLO nebulizer opening the upper part and pouring the drug prescibed by your doctor into the lower tank Close the nebulizer Connect the air tube into the air outlet placet above the knob of nebulization Connect the other end of air tube into the bottom of the nebulizer Connect the selected accessory to the nebulizer child mask adult mask mouthpiece or nosepiece Make sure the air filter is placed properly in its seat in the bottom of the device Air Filter replacement Open the air filter cover remove the filter and insert the new one Place back the cover Press the ON OFF switch to position I to start nebulization e To interrupt or stop the treatment press again the ON OFF switch e Adjust the nebulization speedy by turning the know towards MIN for longer treatments or towards MAX for quicker treatments e After treatment has been completed press the ON OFF switch to position 0 and pull out the plug from the wall socket Wash the nebulizers and the accessories as explained in the Cleaning section e Place back power cord and accessories into the compartments Always use the nebulizer facing upwards so that substances and or medicines cannot es
6. ants that are not in compliance with the regulations in force 8 Particular precautions must be made concerning electromagnetic compatibility The medical device must be installed and used according to information supplied with the accompanying documents 9 Some components of the device are small enough to be swallowed by children therefore keep the device out of children s reach 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 11 Remember to e Only use this device with medicines prescribed by your doctor e Carry out the treatment only using the accessory indicated by the doctor according to the pathology 10 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 exclu
7. cape from the nebulizer during the normal use NEVER INHALE IN HORIZONTAL POSITION NEVER BEND THE NEBULIZER OVER 60 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 MAINTENANCE The CLINEB atomiser does not need maintenance or lubrication Before use always check correct functioning and safety of the device Carry out disinfection as described in the CLEANING ACCESSORIES section Unpack the instrument and always check integrity of plastic parts and feeding cable they might have been damaged during previous use Connect cable to electrical network and turn switch on Close the air outlet with one finger to make sure that noise produced is regular and there is no malfunctioning With the air outlet always closed check the correct functioning of the nebulization regulator by turning the knob form MIN to MAX Make sure the indicator of the pressure meter is working correctly Verify that the atomiser is not damaged by previous use it was badly put away or badly knocked A protection fuse F 1x1 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 Fault type 1 The device doesn t work a The plug may be misplaced in the wall a Make sure the plug is properly placed in the wall socket socket Make sure the ON OFF switch is in
8. ion 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 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 Ifthe 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 4 Never leave the appliance inserted if not necessary disconnect the plug from the mains power supply when it is not being used 5 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 Never immerge the appliance into water Position the appliance on flat stable surfaces Position the device in a way that the air inlets on the back aren t obstructed Neve
9. o 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 snc 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 Directive and its normatives TECHNICAL CHARACTERISTICS TYPOLOGY MDD 93 42 EEC Dispositivo Medico Classe lla MODEL CLINEB POWER FEEDING 230V 50Hz 110V 60Hz no CE 0123 NEB RATE with 4ml of 0 9 NaCI solution measured as specifications of EN 3544 1 to 40T and 110 operating voltage ACCURACY OF PRESSURE METER MIN CAPACITY NEBULIZER MAX CAPACITY NEBULIZER WORKING CONDITION Room temperature 10 40C Altitude 0 2000m s l m Room humidity percentage 10 95 RH J K s speedymed f 5 2 l min 60 e 40 l min 5 0 l min CUMULATIVE UNDERSIZE x CUT OFF um MMAD Mass Median Aerodynamic Diameter GSD Geometric Standard Deviation SYMBOLS Class II isolation equipment CE marking in conformity with EC directive 93 42 EEC Manufactured by CA MI snc di Attolini Mario amp C Via Ugo La Malfa nr 31 43010 Pila
10. r use the device in environments which have anaesthetic mixtures inflammable with air oxygen or nitric oxide Don t touch the device with wet hands and always prevent the appliance coming into contact with liquids The use of this device by children and or incompetent person always requires the careful surveillance of an adult in possession of their full mental faculties e The medical device and most of all the nebulae must be kept out of children s reach as it contains small parts hat could be swallowed 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 e Preserve and use the medical device in environments protected from atmospheric factors and at a distance from heat sources e Device not suitable for anesthesia and lung ventilation 6 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 7 This medical device must be destined exclusively for the use for witch it has been designed ad described in this manual It must therefore be used as an aerosol therapy system 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 pl
11. sion 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 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 t
12. stro PR Italy Warning consult the instruction manual To Preserve in place coolness and dry land Conservation temperature 25 70 C Type B equipment Fuse Alternate Current Mains Frequency EN EN E CLEANING DEVICE Use a soft dry cloth with not abrasive and not solvent detergets N MAKE SURE THAT INTERNAL PARTS OF THE APPLIANCE DON T COME INTO CONTACT WITH LIQUIDS AND THE PLUG IS NOT INSERTED CLEANING THE ACCESSORIES Procced as follows to disinfect the accessories 1 Turn the upper part of the nebulizer in an anti clockwise direction 2 Disconnect the internal pisper at the base of the nebulizer using the fingers 3 Use denatured alcohol or a hypochlorite based solution easily found at chemist to clean the accessories 4 After using the appliance disassemble the nebulizer and clean all parts in warm water rinse carefully and remove excess water using a soft cloth and leave to dry in a clean place DO NOT BOIL OR PUT IN AUTOCLAVE THE ACCESSORIES After each treatment clean thoroughly each component of the nebulizer except air tube removing medication residual and possible impurities Clean all parts in warm water Rinse thoroughly making sure that all deposits are washed away and let dry Guidance and manufacturer s declaration Electromagnetic Emissions The CLINEB aerosol is intended for use in the electromagnetic environment specified below The customers or the user of the CLINE
13. voltage interruptions 5 Ur for 0 5 cycle Mains power quality should be that of a and variations 40 U for 05 cycle typical commercial environment or IEC EN 61000 4 11 70 U for 25 cycle hospital If the user of the CLINEB lt 5 Ur aerosol request that the appliance for 5 sec operates continuosly 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 GEN eIODAS feraphanestetsentie supporti IEC EN 61000 4 6 for appliances that aren t life supporting EN NNFTUU IEC EN 61000 4 3 for appliances that aren t life equipment STANDARD ACCESSORIES ACCESSORIES HI FLO KIT Nebulizer HI FLO Adult Mask Pediatric Mask Air Tube and Mouth piece Air Filter n 3 spare part For each individual patient it s recommended to use the nebulizer for 6 months or for a maximum of 120 treatments The nebulizer must be replaced after a long period of inactivity if it is deformed or broken or if the nebulizer nozzle is blocked by dry medicine dust ecc Only use the original nebulizer supplied by CA MI with the device The air filter must be replaced every 25 hours of functioning or when it result particulary worn For replacement lift the filter and replace with a new one Only use original CA MI filter N DON T USE THE DEVICE WITHOUT AIR FILTER 14 INSTRUCTIO
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