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Pari PEP S, Instructions For Use Manual

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Summary of Contents for PEP S

Page 1: ...Instructions for use PARI PEP S System Model PARI PEP S System Type 018 PEP therapy system PARI inhalation system accessories for combination therapy en...

Page 2: ...and design changes and printing errors reserved The same applies to illustrations Disclaimer These instructions for use describe the components of PARI products and optional accessories For this reas...

Page 3: ...ignations 10 Product combinations 11 Description of function 11 Material information 12 Calibration 13 Operating life 13 USE 14 Preparing for treatment 14 Performing treatment 16 REPROCESSING IN HOME...

Page 4: ...REPROCESSING IN PROFESSIONAL HEALTH INSTI TUTIONS 25 Reprocessing cycles 25 Processing limits 25 PARI PEP S System 26 Connection tubing 33 Visual inspection and storage 33 FURTHER INFORMATION 34 4...

Page 5: ...a home environment as well as in professional health institutions When used in a home en vironment this PARI product is intended for single patient use only no patient change In a professional enviro...

Page 6: ...ng symbols can be found on the product and or the packaging Medical device Legal manufacturer Date of manufacture This product conforms to the EU Medical Device Regulation 2017 745 Consult instruction...

Page 7: ...also be followed Labelling and classification of warning instructions In these instructions for use safety critical warnings are cat egorised according to the following hazard levels DANGER DANGER ind...

Page 8: ...herapy ses sion without assistance or cannot appreciate the hazards the risk of injury is greater e g strangulation with the power cord or the connection tubing Such individuals include for example ba...

Page 9: ...irst time Always use drinking water for reprocessing Make sure all components are dried properly after each re processing step Do not keep the product components in a damp environ ment or together wit...

Page 10: ...components 2 2 Overview and designations 1 2 3 4 5 6 6a 6b 6c 6d 1 Connecting element 2 Adjusting ring 3 Inhalation valve 4 Mouthpiece without exhalation valve 5 Nose clip 6 Pressure gauge 0 to 100 m...

Page 11: ...therapy PEP therapy In PEP therapy expiratory resistance when exhaling is in creased by the different sizes of the holes in the PARI PEP S System the smaller the hole the greater the resistance The in...

Page 12: ...ing PEP therapy The pressure gauge is connected to the PARI PEP S System by tubes The pressure gauge connector line and the tubing adapter prevent any germs from the exhaled air from getting into the...

Page 13: ...ting life The individual product components have the following expec ted lifetimes Product component Service life PARI PEP S System connector line tubing adapter connection tubing in home environment...

Page 14: ...e Push the PEP S adjusting ring onto the PEP S connecting element Align the adjusting ring so that the hole with the diameter re commended by your doctor or therapist is positioned over the hole in th...

Page 15: ...lation valve washer is seated correctly Combination therapy Assemble the nebuliser without mouthpiece as de scribed in the accompanying instructions for use Attach the PEP S connecting element to the...

Page 16: ...Insert the corresponding end of the connection tubing in the pressure gauge Connect the connection tubing and the pressure gauge con nector line using the tubing adapter 3 2 Performing treatment All...

Page 17: ...n the pressure gauge If this is constantly different from the prescribed value the expiratory resistance must be adjusted see Adjusting expiratory resistance page 14 PEP therapy Block your nose with t...

Page 18: ...t For reasons of hygiene avoid coughing into the PARI PEP S System If the PEP therapy is to be terminated before the end of the nebuliser therapy then the combination therapy can be paused and the PAR...

Page 19: ...the pressure gauge and connection tubing page 24 The maximum operating life of the connection tubing is 1 year 4 1 Reprocessing cycles PARI PEP S System Clean immediately after every use Disinfect on...

Page 20: ...stem from the nebuliser Dismantle the PARI PEP S system into its individual parts Open the cap on the connecting element 4 4 Cleaning Precleaning All individual parts must be precleaned immediately af...

Page 21: ...all parts on a dry clean and absorbent surface and allow them to dry completely If the pressure gauge connector line is visibly soiled replace it In the dishwasher The individual parts can be cleaned...

Page 22: ...ocedures are described below In boiling water EQUIPMENT Clean cooking pot Drinking water PROCEDURE CAUTION Risk of infection due to moisture Moisture encourages the growth of bacteria Remove all parts...

Page 23: ...tor switches off automatically or the minimum disinfection time stated in the instructions for use of the disinfector has elapsed Do not switch the device off prematurely CAUTION Risk of infection due...

Page 24: ...ts after each cleaning and disin fection Replace any broken deformed or seriously discoloured parts 4 8 Drying After each cleaning and disinfection place all product compon ents on a dry clean and abs...

Page 25: ...mediately after every use Disinfect once a week Before a change of patients PARI PEP S System Cleaning Disinfection Sterilisation Connection tubing Mechanical cleaning with disinfection 5 2 Processing...

Page 26: ...carry out mechanical cleaning and disinfection of the connection tubing see Connection tubing page 33 All components of the PARI PEP S System can be cleaned disinfected and sterilised according to the...

Page 27: ...re completely submerged in the solution for the whole of the treatment time There must not be any air pockets or bubbles Clean all individual parts with a solution prepared according to the manufactur...

Page 28: ...ion 0 5 Deionised water Cleaning and disinfection device Steelco DS800 in conformance with DIN EN ISO 15883 1 and 15883 2 Info If a different alkaline cleaning agent is used it may also be necessary t...

Page 29: ...ng to the manufacturer s instructions Info If the recommended treatment time is exceeded significantly the plastic parts may take on the smell of the disinfectant RINSING CAUTION Disinfectant residues...

Page 30: ...due to growth of bacteria Inadequate disinfection encourages the growth of bacteria and thus increases the risk of infection Observe the mixing proportions indicated and the spe cified treatment time...

Page 31: ...inse the product thoroughly to ensure that no residues of the disinfectant remain on the PARI product Rinse all parts thoroughly under running drinking water at approx 15 C for 3 minutes Dispose of th...

Page 32: ...285 or DIN EN 13060 Sterile barrier system in accordance with DIN EN 11607 1 Temperature 132 C 134 C Holding time min 3 minutes PROCEDURE Pack all of the disassembled parts in a sterile barrier syste...

Page 33: ...Vario TD program or comparable valid programs DRYING Dry the connection tubing as described in the section on this topic Drying Connect the connection tubing to a compressed air source compressor or c...

Page 34: ...6 FURTHER INFORMATION All product components may be disposed of with normal do mestic waste The country specific disposal regulations must be observed 34...

Page 35: ...35...

Page 36: ...2021 PARI GmbH Spezialisten f r effektive Inhalation 018D2000_en E en 2021 12 05 PARI GmbH Spezialisten f r effektive Inhalation Moosstra e 3 82319 Starnberg GERMANY info pari de www pari com...

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