Pari LC SPRINT Junior Instructions For Use Manual
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Instructions for use
PARI LC SPRINT
PARI LC SPRINT
PARI LC SPRINT
PARI LC SPRINT
Model: PARI LC SPRINT (Type 023)
Nebulisers for PARI inhalation systems
Important: Read these instructions carefully before using
the product for the first time. Follow all instructions and
safety instructions!
Keep the instructions in a safe place.
®
®
Junior
®
STAR
®
BABY
en
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Summary of Contents for Pari LC SPRINT Junior
- Page 1 PARI LC SPRINT STAR ® PARI LC SPRINT BABY Model: PARI LC SPRINT (Type 023) Nebulisers for PARI inhalation systems Important: Read these instructions carefully before using the product for the first time. Follow all instructions and safety instructions! Keep the instructions in a safe place.
- Page 3 – 3 – Identification, validity, version These instructions for use are valid for PARI nebulisers (Type 023) in the following countries: Countries outside the EU Version of these instructions for use: Version F – 2019-11, Approved version dated 2019-11-15 Information as of: 2019-11 The current version of the instructions for use can be down- loaded from the internet as a PDF file: www.pari.com (on the respective product page)
- Page 4 – 4 – Contact For all product information and in the event of defects or ques- tions about usage, please contact our Service Center: Tel.: +49 (0)8151-279 220 (international) +49 (0)8151-279 279 (German-speaking) E-Mail: info@pari.de...
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Page 5: Table Of Contents
– 5 – TABLE OF CONTENTS IMPORTANT INFORMATION.......... Intended purpose ............. Indication ................Contraindications.............. Safety instructions ............PRODUCT DESCRIPTION ..........Components ..............Product variants ............... Product combinations ............Description of function ............Material information ............Operating life ..............USE .................. Preparing for treatment ............ - Page 6 – 6 – MISCELLANEOUS ............Disposal................Labelling ................APPENDIX: Reprocessing in professional environ- ments for use with several patients ......Nebuliser ................Connection tubing ............
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Page 7: Important Information
The nebuliser must only be used with a PARI compressor. For reasons of hygiene, this PARI product must only be used in a home environment by a single patient. The inhalation system must only be used by individuals who understand the contents of the instructions for use and are able to operate the inhalation system safely. -
Page 8: Indication
The user must follow these in order to guarantee safe op- eration of this PARI product. This PARI product must only be used 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 – Hazard due to small parts which can be swallowed The product contains small parts. Small parts can block the air- ways and lead to a choking hazard. Keep all components of the product out of the reach of babies and infants at all times. Hygiene Observe the following hygiene instructions: –...
- Page 10 – 10 – Identifying and classifying warning instructions Safety-critical warnings are categorised according to the following hazard levels in these instructions for use: DANGER DANGER indicates a hazardous situation which will lead to severe injuries or death if it is not avoided. WARNING WARNING indicates a hazardous situation which can lead to severe injuries or death if it is not avoided.
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Page 11: Product Description
(1f) Connection tubing (2) Air filter for compressor types 128/130/152 (3) Air filter for compressor type 085 3) With PARI PIF-Control System. PIF = Peak Inspiratory Flow (inhalation peak flow control) [see: Performing treatment, page 19]. Not included with all product variants. 4) Not included with all product variants. -
Page 12: Product Variants
– 12 – 2.2 Product variants The PARI LC SPRINT nebuliser is available for various age groups and requirements: – PARI LC SPRINT (nozzle insert: blue) With mouthpiece for treatment of the airways in adults and children aged 4 years and older. – PARI LC SPRINT Junior (nozzle insert: yellow) With mouthpiece or PARI BABY mask and PARI BABY... -
Page 13: Description Of Function
– 13 – 2.4 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: Material Information
– 14 – 2.5 Material information The individual product components are made from the follow- ing materials: Product component Material Nebuliser upper part Polypropylene, thermoplastic elastomer Nozzle insert Polypropylene Nebuliser lower part Polypropylene, thermoplastic elastomer LC interrupter Polypropylene Mouthpiece (with Polypropylene, thermoplastic elastomer exhalation valve) Connection tubing Polyvinyl chloride... -
Page 15: Use
People who assist others in carrying out the therapy must ensure that all of the steps described below are carried out correctly. If the nebuliser is to be operated via a PARI CENTRAL on a central medical gas supply, the instructions for use of the PARI CENTRAL must be followed. - 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 lid 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.
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Page 18: Performing Treatment
– 18 – 3.2 Performing treatment All of the safety instructions in these instructions for use must have been read and understood before any treatment is carried out. Always hold the nebuliser upright during treatment. Proceed as follows in order to carry out the treatment: •... - Page 19 This in turn may lead to an electric shock. • Check that an aerosol is being generated before you begin the treatment. Information about the PIF-Control System: The PARI PIF-Control System in the nebuliser upper section is designed to help the patient learn a slow, controlled inhalation technique.
- Page 20 – 20 – Inhaling with the mouthpiece • Sit in an upright position and relax. • Hold the mouthpiece between your teeth and enclose it with your lips. • Breathe in as slowly and deeply as possible through the mouthpiece, and out again calmly. •...
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Page 21: Ending The Treatment
– 21 – Inhaling with accessories Inhalation with accessories (e.g., masks) is described in the instructions for use of the respective accessory. 3.3 Ending the treatment To end the treatment, proceed as follows: • Switch the compressor off. • Place the nebuliser back in the holder on the compressor. •... -
Page 22: Reprocessing
– 22 – REPROCESSING The product components must be cleaned thoroughly immediately after each use and disinfected at least once a day. If the nebuliser is used in professional environments, follow the information on reprocessing included in the appendix at the end of these instructions for use. -
Page 23: Disinfecting
– 23 – 4.3 Disinfecting After cleaning, disinfect all of the disassembled parts (only parts that have been cleaned can be disinfected effectively). The recommended disinfection procedures are described below. Descriptions of other validated disinfection procedures are available from the manufacturer or dealer upon request. The connection tube cannot be cleaned or disinfected. -
Page 24: Care Of The Connection Tube
– 24 – Using a standard thermal disinfector for baby bottles (not a microwave oven) CAUTION Risk of infection due to inadequate disinfection Inadequate disinfection encourages the growth of bacteria and thus increases the risk of infection. • Make sure that the disinfector is clean and operating properly before every disinfection process. -
Page 25: Drying
– 25 – 4.6 Drying After each cleaning and disinfection, place all product compon- ents on a dry, clean and absorbent surface and let them dry completely. 4.7 Storage Store this product as described below: • Wrap all individual components in a clean, lint-free cloth (e.g., a tea towel). -
Page 26: Technical Data
– 26 – TECHNICAL DATA 6.1 General nebuliser data Size 10 cm × 10 cm × 4 cm Weight 31 g to 33 g Operating gases Minimum compressor flow 3.0 l/min. Minimum operating pressure 0.5 bar / 50 kPa Maximum compressor flow 6.0 l/min. Maximum operating pressure 2.0 bar / 200 kPa Minimum fill volume 2 ml Maximum fill volume 8 ml... - Page 27 Aerosol output rate 0.07 0.16 0.18 [ml/min] Residual volume 1.16 1.16 1.10 [ml] (gravimetric) Percentage of fill volume emitted per minute [%/min] 7) Operation with PARI BOY compressor (Type 130). 8) MMAD = Mass Median Aerodynamic Diameter 9) GSD = Geometric Standard Deviation...
- Page 28 – 28 – Minimum com- Nominal com- Maximum com- pressor flow pressor flow pressor flow Nozzle insert (red) (3 l/min – (5 l/min – (6 l/min – 0.6 bar) 1.6 bar) 1.9 bar) MMAD [µm] 2.10 2.00 2.08 Respirable fraction 74.0 79.6 80.6 [% < 5 µm] Aerosol fraction 26.4 30.3 34.6 [% < 2 µm]...
- Page 29 – 29 – Minimum com- Nominal com- Maximum com- Nozzle insert pressor flow pressor flow pressor flow (3 l/min – (5 l/min – (6 l/min – (yellow) 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]...
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Page 30: Miscellaneous
– 30 – MISCELLANEOUS 7.1 Disposal All product components can be disposed of with domestic waste unless this is prohibited by the disposal regulations prevailing in the respective member countries. 7.2 Labelling The following symbols can be found on the product and/or the packaging: Legal manufacturer The product satisfies the basic requirements as set forth... -
Page 31: Appendix: Reprocessing In Professional Environments For Use With Several Patients
– 31 – APPENDIX: Reprocessing in professional environments for use with several patients Nebuliser The following overview of the processing steps in professional environments applies to the following products: – Nebuliser – LC interrupter 1. Preparation Disassemble the product [see: Preparation, page 22]. Check: –... - Page 32 – 32 – 2. Cleaning and disinfection ® Manual pH-neutral, enzymatic cleaner, e.g., Korsolex ® cleaning: Endo Cleaner (Bode) or Bodedex forte (Bode) Use: In accordance with manufacturer information, if dirt is visible use a brush if necessary. Manual With aldehyde-containing instrument ®...
- Page 33 – 33 – 3. Steam sterilisation Equipment: – Steam steriliser (preferably with fractionated pre-vacuum) in accordance with DIN EN 285 or DIN EN 13060 (Type B) – Sterile barrier system in accordance with DIN EN 11607 Temperature / Duration: 134 °C for at least 3 min. 4. Visual inspection & storage Check: Inspect all individual parts.
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Page 34: Connection Tubing
– 34 – Connection tubing 1. Preparation Check the product: – Expiry date of the cleaning agent/disinfectant – Processing limits reached? 2. Cleaning and disinfection Manual not applicable cleaning: Manual not applicable disinfection: ® Mechanical Alkaline cleaning agent, e.g., neodisher cleaning with MediClean forte (Dr. Weigert) in conjunction with ®... - Page 35 – 35 – 4. Visual inspection & storage Inspect all individual parts. Replace any broken, misshapen or seriously discoloured parts. Storage location: – dry – dust-free – protected from sources of contamination optional: Use sterile packaging Processing limits max. 50 processing cycles...
- Page 36 PARI GmbH Spezialisten für effektive Inhalation Moosstraße 3 82319 Starnberg • GERMANY info@pari.de • www.pari.com...
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