OPERATING INSTRUCTIONS
MEDAP
HAND-HELD NEBULISER
GA 5750.4172 EN 14
Page 1: ...OPERATING INSTRUCTIONS MEDAP HAND HELD NEBULISER GA 5750 4172 EN 14 ...
Page 2: ...0 4172 EN 14 2 Subject to technical modification Illustrations and technical specifications may vary slightly from those in these Operating Instructions as a result of ongoing product development V14 2016 07 ...
Page 3: ...cordance with the intended purpose 8 1 5 3 Applicable standards 9 1 5 4 Intended purpose 9 1 5 4 1 Incorrect operation contraindications 10 1 5 4 2 Possible applications 10 1 5 5 Interface description 11 1 5 5 1 General 11 1 5 5 2 Dimensions for the connector keyed to a particular type of gas 11 1 5 5 3 Regulating unit 11 2 Principal safety notes 12 2 1 General safety notes 12 3 Initial operation ...
Page 4: ... Cleaning 24 6 3 1 General 24 6 3 2 Cleaning procedure 25 6 3 3 Cleaning of suction sleeve and nozzle 25 6 4 Disinfection 26 6 4 1 General 26 6 4 2 Suitable disinfectants 26 6 4 3 Disinfection procedure 27 6 4 4 Disinfection procedures 27 6 4 5 Special safety notes 27 7 Maintenance 29 7 1 Visual and functional inspections 29 7 2 Maintenance 29 7 3 Repairs 29 8 Technical specifications 31 8 1 Gener...
Page 5: ...e contaminated after use Clean and disinfect the product before disposal 1 4 How to use these operating instructions 1 4 1 General These operating instructions are provided to familiarise you with the features of this ATMOS product They are subdivided into several chapters Please note Please read these operating instructions carefully and completely before using the product for the first time Alwa...
Page 6: ...tential risk to persons or property which may result in health hazard or grave property damage CAUTION Indicates a potential risk to property which may result in property damage Tab 1 Design of safety notes 1 4 4 2 Design for other notes Notes not referring to personal injury or property damage are used as follows Pictogram Descriptor Reference to NOTE Supplementary assistance or further useful in...
Page 7: ...abelling in compliance with the EN 980 standard Symbol for Serial number Labelling in compliance with the IEC 60601 1 standard Symbol for Follow Operating Instructions Material designation for the plastic PA polyamide Material designation for the plastic PSU polysulfone Packaging label Symbol for Keep dry Transportation label Symbol for Temperature limitations Transportation label Symbol for Relat...
Page 8: ...1 Profile seal 4 Medicine cup 12 O ring 5 Adapter 13 Nozzle 6 Knurled head screw 14 Suction sleeve 7 Connector 15 Piece of tube 8 Connection thread 16 Cleaning needle 1 5 2 Use in accordance with the intended purpose Product As per appendix IX of the Medical Products Directive 93 42 EU this product belongs to class IIb In accordance with this directive the product may only be used by persons who h...
Page 9: ...medication The medication is separated into tiny drops in the medication cup aerosol size of 0 5 7 μm at 500 kPa and supplied to the patient through the inhalation mask approx 2 ml 10 min Only use the hand held nebuliser in conjunction with a regulating unit flowmeter precision regulation valve or pressure reducing valve with O2 or Air flowmeter which has a minimum litre capacity of 13 l min and a...
Page 10: ...ection to an Air flowmeter The flow of volume supplied to the hand held nebuliser is regulated by S FLOW A 15 LS FLOW A 15 FINA FLOW A 15 Connection to FINA O2 precision regulation valve The flow of volume supplied to the hand held nebuliser is regulated using the FINA RV O with O2 M 15x1 G 3 8 connection tube Connection to FINA AIR precision regulation valve The flow of volume supplied to the han...
Page 11: ...m as well as the functional testing are subject to the overall responsibility of the medical staff Functionality and suitability of the connected accessory for each intended application must be checked by the operator before every use This includes the functionality of the connector components its air tightness and suitability regarding material properties working pressure and flow rate 1 5 5 2 Di...
Page 12: ...failure Only use original accessories or spare parts DANGER Observe hygiene guidelines Contaminated components may be hazardous to the patient s health Prepare the product according to the hygiene guidelines before using it for the first time Clean and disinfect the product DANGER Fire explosion hazard Air oxygen and oxygen compounds react explosively with oils greases and lubricants Fire and expl...
Page 13: ...mechanical forces of the connected accessory may affect the product in order to avoid functional failures or damages WARNING Configuration of the overall system The configuration of the overall system as well as the functional testing are subject to the overall responsibility of the medical staff The operator must check proper functionality and suitability of the product for each intended applicat...
Page 14: ...ay only be operated when it is vertical The patient must be cooperative and must be able to press the hand held nebulizer to his her mouth and nose in vertical position WARNING Reasons for poor performance Operating pressures other than 500 kPa 10 may cause deviations in the performance of the hand held nebuliser ...
Page 15: ... connected _ _ Ensure that the thread G 3 8 M 18x1 of the fine regulating valve flowmeter or pressure reducing valve with flowmeter matches the connection tube to be connected 3 2 Assembly of hand held nebuliser 7 8 6 4 9 1 2 3 5 Fig 2 Assembly of hand held nebuliser _ _ Insert the groove of the nozzle 1 into the gap of the suction sleeve 2 9 9 The nozzle engages with an audible click 9 9 Bore hol...
Page 16: ... basic unit with one hand when installing or removing accessories in order to compensate for the tensile forces which are created NOTE Connection thread of hand held nebuliser M 15x1 Connection thread for O2 connection tube to regulating unit G 3 8 Connection thread for Air connection tube to regulating unit M 18x1 3 4 1 Connection of FINA FLOW O 15 2 1 3 4 5 6 Fig 3 Connection of FINA FLOW O 15 _...
Page 17: ...er coupling ring 5 onto the connector 6 of the hand held nebulizer _ _ Pay attention that no tensile forces affect the hand held nebulizer 3 4 3 Connection of the LS FLOW flowmeter 1 2 3 4 5 6 Fig 5 Connection of the LS FLOW flowmeter _ _ Ensure that the coupling ring of the connection tube is fitted with flat gaskets _ _ Ensure that the adapter contains a flat gasket _ _ Screw adapter 1 directly ...
Page 18: ...e _ _ Tighten the connection tube with the smaller coupling ring 4 onto the connector 5 of the hand held nebulizer _ _ Pay attention that no tensile forces affect the hand held nebulizer 3 4 5 Connection of O2 pressure reducing valve with flowmeter 1 2 3 4 Fig 7 Connection of O2 pressure reducing valve with flowmeter _ _ Tighten the connection tube 1 with the larger coupling ring 2 fingertight ont...
Page 19: ...gular operation To be performed by technical staff _ _ Take hand held nebulizer from the rail bracket 1 and hand it to the patient _ _ Open regulating unit 2 on the fine regulating valve 2 1 Fig 9 Regular operation To be performed by patient _ _ Place inhalation mask 1 to mouth and nose with slight pressure _ _ Turn knurled head screw upward 9 9 Hand held nebulizer is set to continuous nebulisatio...
Page 20: ...bulizer is set to continuous nebulisation 4 3 Taking the unit out of operation The FINA fine regulating valve is used to describe how to take the unit out of operation 1 2 Fig 11 Taking the unit out of regular operation Taking the unit out of regular operation _ _ Release the knurled head screw 1 and close _ _ If the inhalation is interrupted for a longer time close the gas supply on the regulatin...
Page 21: ...Taking the unit out of continuous operation Taking the unit out of continuous operation _ _ Close the knurled head screw 1 after completing inhalation _ _ If the inhalation is interrupted for a longer time close the gas supply on the regulating unit 2 of the fine regulating valve ...
Page 22: ... head screw Nozzle suction sleeve or piece of tube is contaminated Clean contaminated parts Defective connection tube or improper screw connection Check or if necessary replace connection tube Connection tube is missing or defective Check or if necessary replace the seal O ring 4 x 1 5 is missing or defective Check or if necessary replace O ring Filling level too low Fill hand held nebuliser Medic...
Page 23: ...n cause property damage Do not use the following products for cleaning and disinfection Products containing alcohol e g hand disinfectants Halogenides e g fluorites chlorides bromides iodides Dehalogenating compounds e g fluorine chlorine bromine iodine Products that may scratch the surface e g scouring agents wire brushes wire wool Standard commercial solvents e g benzene thinner Water containing...
Page 24: ...zle 6 separate suction sleeve 7 and piece of tube 8 6 3 Cleaning 6 3 1 General NOTE In the event of very dirty product surfaces carry out an additional disinfection procedure before cleaning the product NOTE Use only all purpose cleaners which are slightly alkaline soap solution and contain tensides and phosphates as the active cleaning agents In the event of heavily contaminated surfaces use conc...
Page 25: ...rpose detergent solution _ _ Ensure that the product is free of contamination and encapsulated particles of grime _ _ Thoroughly wipe off the product with a soft cloth dipped in clean water _ _ Ensure that the product is free of detergent residues _ _ Dry product with a dry absorbent and lint free cloth 9 9 This will help to reduce pathogen growth on the product s surface _ _ Wipe or spray disinfe...
Page 26: ...nsure that no disinfectants enter the unit Check the functionality of the product after each disinfection CAUTION Risk of injury Do not use any disinfection agents that would jeopardize patients personnel or the functionality of the product Do not disinfect with phenoles or agents that split halogen chlorine or oxygen Do not disinfect with solvents benzene thinner Do not spray disinfect 6 4 2 Suit...
Page 27: ...ents depending on the properties of the materials Components In solu tion1 Wiping2 Autoclaving with heated steam3 up to 134 C Gas sterilisation Nebulizer housing X Medicine cup X X X X Suction sleeve Nozzle Piece of tube Inhalation mask Adapter Profile seal 1 After exposure as prescribed in the manufacturer s instructions rinse components thoroughly with water and dry them afterwards 2 After expos...
Page 28: ...treatment DANGER Health hazard The product is used to administer medication Residues of sterilisation gases or other substances in the product can endanger the patient s health Ensure the product is thoroughly degased after gas sterilisation CAUTION Property damage due to tension cracks Do not treat polysulphone containers with strong acids or alkaline solutions NOTE For notes on cleaning disinfec...
Page 29: ...ections The following table can be used as a template Suggestion No Inspection Defects are present No defects 1 Has the product been cleaned and disinfected according to the hygiene guideline _ _ Do not use the product any longer _ _ Clean and disinfect the product according to the guideline Comment 2 Space for other tests Tab 6 Visual and functional inspections 7 2 Maintenance We recommend having...
Page 30: ...lists and testing schedules for system components that ATMOS has deemed to be repairable in the field If defects are detected the product may not be used any longer Make a note of the deficiencies and the REF number on the data plate and notify the responsible ATMOS Service Inform the appropriate foreign representative outside Germany ...
Page 31: ...inciple Venturi system Max fill level 10 ml Connection thread of O2 flowmeter M 15x1 Diameter of droplets at 500 kPa 0 5 7 µm Nebulising volume at 500 kPa approx 2 ml 10 min Gas consumption 13 Nl min 100 kPa 1 bar 1000 mbar 750 mmHg 8 2 Ambient conditions Temperature 15 C to 50 C shipping 15 C to 30 C in operation Relative humidity 10 to 95 shipping 30 to 75 in operation Atmospheric pressure 700 h...
Page 32: ...on 32 GA 5750 4172 EN 14 8 8 4 Particle size distribution Particle size distribution of the aerosol spray share in particle size in μm The dark bar indicates the mean value Fig 15 Particle size distribution depends on the recorded particle size class ...
Page 33: ...14 33 8 8 5 Cumulative frequency Diagram of cumulative frequency of the average particle size distribution of the aerosol spray share in particle size in μm The darker line indicates the mean value Fig 16 Diagram of the cumulative size distribution of the results ...
Page 34: ... information LS DFLOW O 15 See price information LS FLOW A 15 See price information FINA RV O See price information FINA RV A See price information 9 16 G 3 8 adapter 5752 2745 9 16 M 18x1 adapter 5752 2762 Connection tube oxygen ISO colour coding 5752 5067 Connection tube for compressed air neutral colour 5752 5032 Connection tube compressed air ISO colour coding 5752 5033 Holder with double hook...
Page 35: ...Notes ...
Page 36: ...mbH Kehler Str 31 76437 Rastatt Baden Wuerttemberg GERMANY Telephone 49 7222 932 0 www maquet com Distributor ATMOS MedizinTechnik GmbH Co KG Ludwig Kegel Str 16 79853 Lenzkirch GERMANY Phone 49 7653 689 0 www atmosmed com ...
