Pari LC SPRINT BABY Instructions For Use Manual

For inhalation systems

Hide thumbs Also See for LC SPRINT BABY:

Instructions for use manual (200 pages)

Instructions for use manual (36 pages)

Instructions for use manual (240 pages)

page of 40

/ 40
Bookmarks

Quick Links

Download this manual

Instructions for use

PARI LC SPRINT

Model: PARI LC SPRINT (Type 023)

Nebulisers for PARI lnhalation systems

Junior

STAR

BABY

Need help?

Do you have a question about the LC SPRINT BABY and is the answer not in the manual?

Questions and answers

Summary of Contents for Pari LC SPRINT BABY

Page 1 Instructions for use ® PARI LC SPRINT ® PARI LC SPRINT Junior ® PARI LC SPRINT STAR ® PARI LC SPRINT BABY Model: PARI LC SPRINT (Type 023) Nebulisers for PARI lnhalation systems...
Page 2 PARI products and optional accessories. For this reason, these instructions for use also describe and illustrate features not present in your PARI product because they are, for instance, country-specific and/or optional. When using the systems, products and functions, the applicable country-specific regula- tions must be observed.
Page 3 – 3 – TABLE OF CONTENTS IMPORTANT INFORMATION.......... Intended purpose ............. Indication ................Contraindication ............... Labelling ................Safety and warning instructions ........PRODUCT DESCRIPTION ..........Components ..............Overview and designations ..........Product variants ............... Product combinations ............Description of function ............Material information ............
Page 4 – 4 – REPROCESSING IN PROFESSIONAL HEALTH INSTI- TUTIONS................Reprocessing cycles ............Processing limits .............. Nebuliser ................Connection tubing ............Visual inspection and storage .......... TROUBLESHOOTING ............. TECHNICAL DATA............General nebuliser data ............. Aerosol characteristics according to ISO 27427 ....FURTHER INFORMATION ..........
Page 5 The nebuliser must only be connected with a PARI compressor or with a central gas supply system. The PARI CENTRAL is in- tended for the connection with the central gas supply system. This PARI product can be used in a home environment, as well as in professional health institutions.
Page 6 – 6 – This PARI product is suitable only for patients who are able to breathe by themselves and are conscious. An application takes approximately 5 to 10 minutes (depending on the quantity of fluid), but in any case no more than 20 minutes. The frequency and duration of use is determined by profes-...
Page 7 Consult instructions for use Item no. Production batch number, lot number Connection tubing Nozzle insert (blue) Nozzle insert (red) Nozzle insert (yellow) Mouthpiece PARI LC SPRINT nebuliser LC interrupter Air filter for compressor types 128/130/152 Air filter for compressor type 041 Air filter for compressor types 028/085 Tubing adapter...
Page 8 The user must follow these in order to guarantee safe op- eration of this PARI product. This PARI product must be used only as described in these in- structions for use. The instructions for use of the compressor and accessories used and the information for use of the inhalation solution used must also be followed.
Page 9 – 9 – General Nebuliser aerosol characteristics differ from the information provided by the manufacturer if non-approved solutions or sus- pensions are used for nebulisation. This product is not suitable for use in an anaesthetic breathing system or a ventilator breathing system. Tracheotomised patients cannot inhale with a mouthpiece.
Page 10 Reporting serious incidents Serious incidents which occur in connection with this PARI product must be reported promptly to the manufacturer and/or the distributor, as well as to the competent authority. Any incident which has led or could lead directly or indirectly to death or an unexpected serious worsening of the health condi- tion of a person is to be considered serious.
Page 11 – 11 – PRODUCT DESCRIPTION 2.1 Components Please refer to the package for information on the supplied components. 2.2 Overview and designations (1) Nebuliser (1a) Nebuliser upper part (1b) Nozzle attachment (1c) Nebuliser lower part (1d) Interrupter (1e) Mouthpiece (1f) Connection tubing (2) Air filter for compressor...
Page 12 (including premature babies) and children (aged 0 to 4 years). 2.4 Product combinations The PARI nebuliser can be connected to all PARI compressors or to a central medical gas supply system via a PARI CENTRAL. The nebuliser can be used in combination with a range of PARI accessories.
Page 13 – 13 – 2.5 Description of function The PARI nebuliser is part of a PARI inhalation system. When compressed air is supplied, Ambient air the nebuliser generates an aero- Aerosol sol from the liquid, for example the medication with which it is filled.
Page 14 When the expected lifetime is reached, replace the nebuliser with a new nebuliser. For this, nebuliser replacement sets (a nebuliser with connection tubing) or PARI Year Packs (a nebuliser with connection tubing and an air filter for a com- pressor) are available.
Page 15 All the steps described below must be carried out properly. If the nebuliser is to be connected to a central medical gas sup- ply system via a PARI CENTRAL, the instructions for use of the PARI CENTRAL must be followed. 3.1 Preparing for treatment...
Page 16 – 16 – • Attach the connection tubing to the nebuliser. • 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 the nebuliser.
Page 17 – 17 – Filling the nebuliser NOTE Nebuliser lid might break off If the cap is twisted in the wrong direction, it may break off. The nebuliser will then be unusable and irreparable. • Never move the lid except in the direction allowed by the hinge.
Page 18 – 18 – 3.2 Performing treatment All the safety instructions and warnings in these instruc- tions for use must have been read and understood before any treatment is carried out. Always hold the nebuliser upright during treatment. • If necessary, use the tubing adapter to connect the connec- tion tubing and the com- pressor.
Page 19 – 19 – • Take the nebuliser out of its holder on the compressor and hold it upright. • Verify that all parts are firmly connected to each other. • DANGER! Life-threaten- ing situation from electrocu- tion if there is a device fault! Switch the compressor off im- mediately, and disconnect the power plug from the mains...
Page 20 – 20 – Information about the PIF-Control System: The PARI PIF-Control System in the nebuliser upper section is de- signed to help the patient learn a slow, controlled inhalation tech- nique. This improves uptake of the active agent in the lower air- ways.
Page 21 – 21 – Using the LC interrupter If the LC interrupter is attached, aerosol is not 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.
Page 22 – 22 – REPROCESSING IN A HOME ENVIRONMENT The product components must be cleaned thoroughly immedi- ately after each application and disinfected at least once a week. The connection tubing cannot be cleaned or disinfected. Dry the connection tubing after each use [see: Care of the con- nection tube, page 26].
Page 23 – 23 – 4.4 Cleaning Precleaning All individual parts must be precleaned immediately after use. EQUIPMENT: – Drinking water temperature of about 15 °C PROCEDURE: • Rinse all parts used for 2 minutes in running drinking water. Manual cleaning EQUIPMENT: – Drinking water with a temperature of at least 40 °C –...
Page 24 – 24 – In the dishwasher The individual parts can be cleaned in a standard household dishwasher provided it is connected to a mains water supply of drinking water quality. To ensure safety when handling the cleaning agent used, fol- low the corresponding instructions for use, particularly the ac- companying safety instructions.
Page 25 – 25 – PROCEDURE: CAUTION Risk of infection due to moisture Moisture encourages the growth of bacteria. • Remove all parts from the pot as soon as the disinfection process is finished and allow them to dry. • Place all the individual parts in water at a rolling boil for at least 5 minutes.
Page 26 – 26 – CAUTION Risk of infection due to moisture Moisture encourages the growth of bacteria. • Remove all parts from the disinfector as soon as the disin- fection process is finished and allow them to dry. Regarding the performance of the disinfection, the duration of the disinfection procedure and the quantity of water required, follow the instructions for use of the disinfector you are using.
Page 27 – 27 – • Store all individual components in a dry, dust-free place. REPROCESSING IN PROFESSIONAL HEALTH INSTITUTIONS Dry the connection tubing after each use [see: Connection tubing, page 35]. 5.1 Reprocessing cycles Single patient use Nebuliser without – Clean immediately after every use connection tubing and –...
Page 28 • Replace the connection tubing or carry out mechanical cleaning and disinfection of the connection tubing [see: Connection tubing, page 35]. All components of a PARI nebuliser and the PARI accessories used can be cleaned, disinfected and sterilised according to the procedures described below.
Page 29 – 29 – Cleaning and disinfecting Manual cleaning EQUIPMENT The method has been validated in Europe using: – pH-neutral, enzymatic cleaner: ® Bode Bomix plus (concentration: 0.1%) – Drinking water temperature of about 15 °C – Application time: 10 minutes PROCEDURE: CAUTION Risk of infection due to growth of bacteria Inadequate disinfection encourages the growth of bacteria and thus increases the risk of infection.
Page 30 – 30 – Cleaning with disinfection Cleaning and disinfection can be carried out in a single cycle using a chemical preparation process. To ensure safety when handling chemicals, follow the instruc- tions for use of the disinfectant. Mechanical EQUIPMENT: cleaning with The method has been validated in Europe using: disinfection: –...
Page 31 – 31 – Chemical EQUIPMENT: cleaning with The method has been validated in Europe using: disinfection: – Aldehyde-free instrument disinfectant: Bode ® Bomix plus (concentration: 2%) Active agent basis: Quaternary ammonium compound – Drinking water at approx. 15 °C – Application time: 5 minutes PROCEDURE: •...
Page 32 – 32 – Chemical disinfection To ensure safety when handling chemicals, follow the instruc- tions for use of the disinfectant. EQUIPMENT: The method has been validated in Europe using: ® – Aldehyde-containing disinfectant: Bode Korsolex basic (concentration: 4%) Active agent basis: Aldehyde donor, aldehyde –...
Page 33 • Rinse 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.
Page 34 – 34 – Sterilising CAUTION Risk of infection by residual germs If there is dirt on the parts, germs capable of reproduction may remain despite the sterilisation process. As a result, there is a danger of infection. • Clean, disinfect, and dry all parts thoroughly before steril- ising.
Page 35 – 35 – 5.4 Connection tubing Mechanical cleaning and disinfecting EQUIPMENT: The method has been validated in Europe using: ® – Alkaline cleaning agent: Dr. Weigert neodisher MediClean forte – Neutralising agent: Dr. Weigert neodisher Z – Cleaning and disinfection device: RDG G7836 CD (Miele) (conforming to DIN EN ISO 15883) –...
Page 36 – 36 – TROUBLESHOOTING Contact the manufacturer or distributor: – in the event of faults that are not listed in this chapter – if the suggested procedure does not correct the fault Fault Possible cause Remedy No aerosol is The nebuliser nozzle Clean the nebuliser.
Page 37 31.2 [% > 2 µm < 5 µm] Aerosol fraction 47.7 38.1 39.5 [% > 5 µm] Aerosol output [ml] 0.35 0.41 0.38 Aerosol output rate 0.07 0.16 0.18 [ml/min] 6) Operation with PARI BOY compressor (Type 130). 7) MMAD = Mass Median Aerodynamic Diameter 8) GSD = Geometric Standard Deviation...
Page 38 – 38 – Minimum Nominal Maximum compressor compressor compressor Nozzle insert flow flow flow (blue) (3 l/min – (5 l/min – (6 l/min – 0.6 bar) 1.6 bar) 1.9 bar) Residual volume 1.16 1.16 1.10 [ml] (gravimetric) Percentage of fill volume emitted per minute [%/min] Minimum Nominal Maximum compressor...
Page 39 – 39 – Minimum Nominal Maximum compressor compressor compressor Nozzle insert flow flow flow (yellow) (3 l/min – (5 l/min – (6 l/min – 0.6 bar) 1.6 bar) 1.9 bar) MMAD [µm] 2.08 2.11 2.05 Respirable fraction 61.7 73.3 76.5 [% < 5 µm] Aerosol fraction 17.4 29.5 28.6 [% < 2 µm] Aerosol fraction 44.3 43.8...
Page 40 ©2021 PARI GmbH Spezialisten für effektive Inhalation, 023D2001_en I en 2021-12-05 PARI GmbH Spezialisten für effektive Inhalation Moosstraße 3 82319 Starnberg • GERMANY info@pari.de • www.pari.com...

This manual is also suitable for:

Lc sprint junior Lc sprint star Lc sprint 023