Manuale New Speedymed
Contents
1. for 0 5 cycle Mains power quality should be that of a typical commercial interruptions and variations 40 Us for 05 cycle environment or hospital If the user of the CLINEB aerosol request IEC EN 61000 4 1 1 70 U for 25 cycle that the appliance operates continuosly the use of a continuity unit lt 5 Ur for 5 sec is recommended IEC EN 61000 4 8 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 eguipment Note Uris the value of the power supply voltage CLEANING DEVICE Use a soft dry cloth with not abrasive and not solvent detergets A MAKE SURE THAT INTERNAL PARTS OF THE APPLIANCE DON T COME INTO CONTACT WITH LIQUIDS AND THE PLUG IS NOT INSERTED www nebuliser entre co uk INSTRUCTION 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 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 in2. 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 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 responsibility of CA MI for damages caused by the transport or dismay from the vector Every returned instrument
3. 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 ifa 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 S R L 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 doe
4. FLO GoOINEB WITH PISTON COMPRESSOR USER MANUAL CE 0123 Kitteni t centre www nebulisercentre co uk 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 termal 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 nebulizaer to guarantee quick and accurate drug delivery The device is designed for easy tranport and halding and is recommended for atomising antobiotics and bronchodilator drugs The medical device is designed for continuous use GENERAL WARNING READ INSTRUCTION MANUAL CAREFULLY BEFORE USE A DRUG ADMINISTRATION MUST BE UNDER MEDICAL CONTROL THE INSTRUMENT MUST NOT BE DISASSEMBLED FORA TECHNICAL SERVICE ALWAYS CONTACT CA MI 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 2 before connecting the appliance always check that the electric data
5. S Before undertaking and cleaning operation switch off and unplug the unit CLEANING ACCESSORIES 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 Wash under running water with mild non abrasive washing up liquid 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 DISINFECTION 1 Use denatured alcohol or a hypochlorite based solution easily found at chemist to clean the accessories 2 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 AIR TUBE AND THE MASKS The device isn t sterile Before use carry out cleaning and disinfection operations The nebulizer HI FLO the mouthpiece and the nosepiece must be disinfected by boiling in water for max 10 minutes We suggest you disinfect the nebulizer HI FLO the mouthpiece and the nosepiece using cold disinfecting liquids solutions with hypochlorite Attention Never use a cleaning brush or put sharp objects into the jet holes as this will damage the nebulizer www nebulisercentre co uk Guidance and manufacturer
6. cturer 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 S R L 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 BEFORE EVERY CHECKING OPERATION IN CASE OF ANOMALIES OR BAD FUNCTIONING PLEASE CONTACT CA MI TECHNICAL SERVICE CA MI DOES NOT GIVE GUARANTEE IF INSTRUMENT AFTER THE TECHNICL SERVICE CHECKING APPEARS TO BE TAMPERED www nebuliser entre co uk
7. 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 e Never immerge the appliance into water e Position the appliance on flat stable surfaces e 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 The use of this device by children and or incompetent person always requires the careful surveillance of an adult in po
8. n 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 www nebulisercentre co uk 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 im 2003 108 EC for reduction in use of dangerous substances in the electric and electronic device and for garbage disposal i 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 Ed OA garbage or give back to the retailer in the moment of equivalent new device purchasing one against one Disposing of the product kar separately prevents possible negative consequences for the environment and for health deriving from inadequate disposal It also allows
9. orrect 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 1 The device doesn t work a The plug may be misplaced in the wall Make sure the socket plug is properly placed in the wall socket Make sure the b Thermal protector may be on the device ON OFF switch is in position l has been working beyond its limits and or Switch off the near heat sources device by pressing the switch to position 0 and left the motor cool down for at least 30 minutes 2 Low Nebulization Clogged Nebulizer Tank Clean and disinfect the nebulizer tank as explained in the instruction manual 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 Fault1 2 3 4 5 6 No solution with previous items Call retainer or manufa
10. 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 Emissions Test Compliance Electromagnetic environment guidance 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 The CLINEB aerosol can be used in all environments including domestic Harmonic emissions Class A and those connected directly to the public mains distribution that supplies IEC EN 61000 3 2 power to environments used for domestic scopes Voltage fluctuations flicker emissions Complies IEC EN 61000 3 3 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 Electrostatic discharge ESD 6kV on contact Floors should be wood conceret or ceramic tile If floors are IEC EN 61000 4 2 8kV in air coverei with synthetic material the relative humidity should be at least 30 IEC EN 61000 4 4 environment or hospital IEC EN 61000 4 5 environment or hospital Loss of voltage brief voltage 5 U
11. s not guarantee the compliance with the technical requirements provided by the MDD 93 42 EEC Directive and its normatives www nebulisercentre co uk TECHNICAL CHARACTERISTICS TYPOLOGY MDD 93 42 EEC MODEL POWER FEEDING POWER CONSUMPTION FUSE MAX PRESSURE MAX AIR FLOW OPERATING PRESSURE OPERATING AIR FLOW NEB RATE with 4ml of 0 9 NaCl solution MMAD GSD WEIGHT SIZE NOISE LEVEL measured as specifications of EN 13544 1 DUTY CYCLE to 40 C and 110 operating voltage ACCURACY OF PRESSURE METER MIN CAPACITY NEBULIZER MAX CAPACITY NEBULIZER WORKING CONDITION Room temperature Room humidity percentage 20 85 RH Altitude 0 2000m s l m CONSERVATION CONDITION AND TRASPORT Room temperature 25 70 C Room humidity percentage 10 95 RH a m a Aa a ai A m A 51 Imin an 4 0 l min l F f Za 60 5 0 Umin MMAD CUMULATIVE UNDERSIZE x 0 10 20 30 40 50 CUT OFF um MMAD Mass Median Aerodynamic Diameter GSD Geometric Standard Deviation www nebulisercentre co uk SYMBOLS Class II isolation equipment CE marking in conformity with EC directive 93 42 EEC and subsequent changes Manufactured by CA MI S r l Via Ugo La Malfa nr 31 43010 Pilastro PR Ital 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 CELANING THE ACCESSORIE
12. ssession of their full mental faculties e The device has small components which might be removed and easily swallowed Use by minors and disabled people require presence of an adult with his faculties Don t leave the device unattended in places easily accessible by minors and disabled people e 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 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 plants 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 informatio
13. to 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 to start nebulization To interrupt or stop the treatment press again the ON OFF switch Adjust the nebulization speedy by turning the know towards MIN for longer treatments or towards MAX for quicker treatments 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 Place back power cord and accessories into the compartments Always use the nebulizer facing upwards so that substances and or medicines cannot escape from the nebulizer during the normal use NEVER INHALE IN HORIZONTAL POSITION NEVER BEND THE NEBULIZER OVER 60 SURVEILLANCE AN MAKE SURE THAT CHILDREN AND OR MENTALLY ILL PEOPLE DO NOT USE THE DEVICE WITHOUT ADULT ALWAYS PLACE THE DEVICE IN POSITIONS FOR EASY DISCONNECTION www nebulisercentre co uk STANDARD ACCESSORIES ACCESSORIES HI FLO KIT Nebulizer HI FLO Adult Mask Pediatric Mask Air Tube Mouth piece and Noisepiece Air Filter n 3 spare part For each individual patient it s recommended
14. 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 AN DON T USE THE DEVICE WITHOUT AIR FILTER Air Tube Nebulizer Tank Nebulization Nozze Nebulizer Top Mouthpiece Adult Mask Pediatric Mask Nosepiece tai tal kal kli ee i Use the nose piece accessory only if expressly indicated by your doctor and paying attention NEVER to introduce inside the nose the nasal bifurcation but only bring it as close as possible www nebuliser entre co uk 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 c
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