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7.2 Aerosol characteristics according to

ISO 27427

The aerosol characteristics presented in these instructions for
use were determined in accordance with ISO 27427 using Sal-
butamol. If other solutions or suspensions are used for
nebulisation, the aerosol characteristics may differ from the val-
ues shown (particularly if they have greater viscosity).
The following data is based on tests according to a standard
which takes adult breathing patterns as a basis. Therefore,
these figures will probably differ from corresponding figures
that were calculated for populations of children and infants.

Nozzle insert
(transparent)

Minimum
compressor
flow
(3 l/min. –
0.6 bar)

Nominal
compressor
flow
(4 l/min. –
1.2 bar)

6

Maximum
compressor
flow
(6 l/min. –
1.9 bar)

MMAD [µm]

7

5.4

4.5

3.4

GSD

8

2.13

2.23

2.31

Respirable fraction
[% < 5 µm]

44.0

53.2

66.2

Aerosol fraction
[% < 2 µm]

11.6

17.9

28.1

Aerosol fraction
[% > 2 µm < 5 µm]

32.4

35.3

38.1

Aerosol fraction
[% > 5 µm]

56.0

46.8

33.8

Aerosol output [ml] 0.30

0.40

0.38

Aerosol output rate
[ml/min]

0.09

0.12

0.14

6) Operation with PARI COMPACT2 compressor (Type 152).

7) MMAD = Mass Median Aerodynamic Diameter

8) GSD = Geometric Standard Deviation

– 40 –

Summary of Contents for LC PLUS 022

Page 1: ...Instructions for use PARI LC PLUS Model PARI LC PLUS Type 022 Nebulisers for PARI inhalation systems en...

Page 2: ...rnberg Germany Technical 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 a...

Page 3: ...ignations 11 Product variants 11 Product combinations 12 Description of function 12 Material information 13 Service life 13 USE 14 Preparing for treatment 14 Performing treatment 18 Ending the treatme...

Page 4: ...8 Reprocessing cycles 28 Processing limits 28 Nebuliser 29 Connection tubing 37 Visual inspection and storage 38 TROUBLESHOOTING 39 TECHNICAL DATA 39 General nebuliser data 39 Aerosol characteristics...

Page 5: ...vironment this PARI product is intended for single patient use only no patient change In a professional environment the device can be used with different patients as long as the cor responding hygien...

Page 6: ...frequency and duration of use is determined by profes sional medical staff2 according to the individual needs of the patient 1 2 Indication For treatment of diseases of the lower airways 1 3 Contraind...

Page 7: ...ice Identifier UDI This product conforms to the EU Medical Device Regulation 2017 745 Follow the instructions for use Mouthpiece with exhalation valve Inhalation valve Connection tubing Nebuliser inse...

Page 8: ...d must 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 DAN...

Page 9: ...atient should refrain from using skin care products of this kind while using the device If your health condition does not improve or it even wor sens as a result of the treatment seek professional med...

Page 10: ...esidual moisture encourage bacterial growth which increases the risk of infection Before every use and reprocessing cycle wash your hands thoroughly Make absolutely sure you also carry out reprocessin...

Page 11: ...s 1 1e 1c 1b 1a 1f 1d 2 1 Nebuliser 1a Inhalation valve 1b Nozzle attachment 1c Nebuliser lower part 1d LC interrupter 1e Mouthpiece 1f Connection tubing 2 Air filter for compressor 2 3 Product varian...

Page 12: ...PARI nebuliser is part of a PARI inhalation system Compressed air Aerosol Ambient air Liquid When compressed air is supplied the nebuliser generates an aero sol from the liquid with which it is fille...

Page 13: ...ife The individual product components have the following expec ted lifetimes Product component Service life Nebuliser connection tubing and accessories in a home environment see REPROCESSING IN A HOME...

Page 14: ...UTION Risk of impaired treatment Damaged components and or an incorrectly assembled nebuliser may impair functioning of the nebuliser and thus treatment as well Check all nebuliser components and the...

Page 15: ...ction tubing to the nebuliser Or Attach the LC interrupter to the nebuliser Insert the connection tubing in the air inlet on the side of the LC interrupter Using the mouthpiece Fit the mouthpiece onto...

Page 16: ...r the required quantity of inhalation solution into the nebuliser Be sure to follow the instruc tions regarding the minimum and maximum fill volumes see General nebuliser data page 39 If the nebuliser...

Page 17: ...ns are to be used one after the other Rinse the nebuliser out with drinking water between the indi vidual applications Shake excess water out of the nebuliser Fill the nebuliser with the next inhalati...

Page 18: ...on tubing and the com pressor DANGER Life threaten ing situation caused by mix ing up tubes If tubing sys tems for other devices are present close by e g for infu sions check carefully to en sure that...

Page 19: ...ately and disconnect the power plug from the mains socket if a fault is suspected e g if the device is dropped or there is a smell of burning plastic If there is a device fault there may be a risk of...

Page 20: ...generated until the interrupter button is pressed Proceed as follows to inhale and to interrupt aerosol generation when breathing out Press the interrupter button to generate aerosol Info If the butt...

Page 21: ...nding the treatment To end the treatment proceed as follows Switch the compressor off by shifting the on off switch to OFF Place the nebuliser back in the holder on the compressor Disconnect the power...

Page 22: ...on tubing is 1 year 4 1 Reprocessing cycles Nebuliser Clean immediately after every use Disinfect once per week 4 2 Processing limits Nebuliser and accessories disinfection 300 reprocessing cycles max...

Page 23: ...ut 1 teaspoon of wash ing up liquid to 3 l warm drink ing water Place all the parts in the wash ing up water Application time 5 minutes Occasionally move the parts back and forth If there is visible s...

Page 24: ...icularly the ac companying safety instructions PROCEDURE Do not clean the individual components together with very dirty dishes Place all components in the crockery basket so that no wa ter can collec...

Page 25: ...cteria Remove all parts from the saucepan as soon as the disin fection process is complete and allow them to dry Place all the individual parts in water at a rolling boil for at least 5 minutes NOTE R...

Page 26: ...d in the instructions for use of the disinfector has elapsed Do not switch the device off prematurely CAUTION Risk of infection due to moisture Moisture encourages the growth of bacteria Remove all pa...

Page 27: ...Inspecting Inspect all product components after each cleaning and disin fection Replace any broken deformed or seriously discoloured parts 4 8 Drying After each cleaning and disinfection place all com...

Page 28: ...every use Disinfect once per week Before a change of patient Nebuliser excluding connection tubing but including accessories e g mask Cleaning Disinfection Sterilisation Connection tubing Mechanical...

Page 29: ...echanical cleaning and disinfection of the connection tubing see Connection tubing page 37 All components of a PARI nebuliser and of the PARI accessor ies used can be cleaned disinfected and sterilise...

Page 30: ...the risk of infection Observe the specified mixing proportions and the spe cified treatment time Ensure that all components are completely submerged in the solution for the whole of the treatment time...

Page 31: ...dividual parts thoroughly under running drinking water at approx 15 C for 3 minutes DRYING Shake the water out of all of the parts Place all parts on a dry clean and absorbent surface and allow them t...

Page 32: ...n 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 to...

Page 33: ...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 34: ...due to growth of bacteria Inadequate disinfection encourages the growth of bacteria and thus increases the risk of infection Observe the specified mixing proportions and the spe cified treatment time...

Page 35: ...inse the product thoroughly to ensure that no residues of the disinfectant remain on the PARI product Rinse off all parts thoroughly in running drinking water at about 15 C for 3 minutes Dispose of th...

Page 36: ...ce with DIN EN 285 or DIN EN 13060 Type B Sterile barrier system Temperature 132 C 134 C Holding time min 3 minutes PROCEDURE Place all the disassembled parts in a sterile barrier system which complie...

Page 37: ...r MediClean forte Neutralising agent Dr Weigert neodisher Z Cleaning and disinfection device RDG G7836 CD Miele conforming to DIN EN ISO 15883 Special baskets for Miele instrument dishwasher Compresse...

Page 38: ...source on Leave the compressed air source running until all the mois ture in the tubing has been removed 5 5 Visual inspection and storage Check all individual components Replace any broken de formed...

Page 39: ...c ted properly Check that the tubing con nectors are connected firmly to the compressor and the nebuliser The connection tubing is leaking Replace the connection tubing 7 TECHNICAL DATA 7 1 General ne...

Page 40: ...these figures will probably differ from corresponding figures that were calculated for populations of children and infants Nozzle insert transparent Minimum compressor flow 3 l min 0 6 bar Nominal com...

Page 41: ...r 6 Maximum compressor flow 6 l min 1 9 bar Residual volume ml gravimetric 1 28 1 15 1 14 Percentage of fill volume emitted per minute min 4 4 5 9 6 9 8 FURTHER INFORMATION All product components may...

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Page 44: ...2022 PARI GmbH Spezialisten f r effektive Inhalation 022D3001 A en 2022 09 27 PARI GmbH Spezialisten f r effektive Inhalation Moosstra e 3 82319 Starnberg GERMANY info pari de www pari com...

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