Pari 041 Instructions For Use Manual
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Pari 041 Instructions For Use Manual

Pari 041 Instructions For Use Manual

Filter valve set for inhalation systems
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Instructions for use
PARI Filter Valve Set
(Type 041)
Accessories for PARI inhalation systems
Accessories for the PARI PEP S System
en

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Summary of Contents for Pari 041

  • Page 1 Instructions for use PARI Filter Valve Set (Type 041) Accessories for PARI inhalation systems Accessories for the PARI PEP S System...
  • 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: Table Of Contents

    – 3 – TABLE OF CONTENTS IMPORTANT INFORMATION.......... Intended purpose ............. Indication ................Contraindications.............. Labelling ................Safety instructions ............PRODUCT DESCRIPTION ..........Components ..............Overview and product designations ......... Product combinations ............Description of function ............Material information ............Operating life ..............USE ..................
  • Page 4 – 4 – REPROCESSING IN PROFESSIONAL HEALTH INSTI- TUTIONS................Reprocessing cycles ............Processing limits .............. PARI Filter Valve Set............Visual inspection and storage .......... FURTHER INFORMATION ..........

  • Page 5: Important Information

    – 5 – IMPORTANT INFORMATION 1.1 Intended purpose The PARI Filter Valve Set is an accessory for PARI nebulisers or the PARI PEP S System. The PARI Filter Valve Set reduces the release of the exhaled aerosol into the ambient air.

  • Page 6: Labelling

    Medical device Legal manufacturer Date of manufacture This product conforms to the EU Medical Device Regulation 2017/745. Consult instructions for use Item no. Production batch number, lot number Unique Device Identifier (UDI) Exhalation filter Y-connection PARI filter pad Mouthpiece without expiratory valve...

  • Page 7: Safety Instructions

    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. Please also follow the instructions for use of the nebuliser and compressor you are using.
  • Page 8 – 8 – Hygiene Comply with the following hygiene instructions: – Use only components that have been thoroughly cleaned and dried. Contamination and residual moisture encourage bacterial growth, which increases the risk of infection. – Before every use and reprocessing cycle, wash your hands thoroughly.

  • Page 9: Product Description

    2.1 Components Please refer to the package for information on the supplied components. 2.2 Overview and product designations (1) Exhalation filter (1a) Lower part (1b) Upper part (with exhalation valve) (2) PARI Filter Pad (3) Y-connection (4) Mouthpiece (without exhalation valve)

  • Page 10: Product Combinations

    – 10 – 2.3 Product combinations The PARI Filter Valve Set can be combined with the following PARI products: – PARI jet nebulisers, except PARI LC SPRINT SINUS – PARI membrane nebulisers, such as eFlow®rapid nebuliser. Information about the accessories to be used is included in the instructions for use of the nebuliser.

  • Page 11: Operating Life

    – 11 – 2.6 Operating life The individual product components have the following expec- ted lifetimes: Product component Service life PARI Filter Valve Set in a home environment (exhalation filter, Y-connection, [see: Processing limits, mouthpiece) page 16] PARI Filter Valve Set in a professional environment (exhalation filter, Y-connection, [see: Processing limits,...

  • Page 12: Use

    All the steps described below must be carried out correctly. 3.1 Preparing for treatment Use a PARI Filter Pad for the PARI Filter Valve Set Using accessories Information on assembling accessories is included in the in-...
  • Page 13 • Push the exhalation filter onto the Y-connection. • Push the mouthpiece (without exhalation valve) onto the Y-connection. Connecting the PARI Filter Valve Set with the PARI PEP S System • Assemble the PARI PEP S system without mouthpiece, as described in the instructions for use of the PARI PEP S system.

  • Page 14: Performing Treatment

    – 14 – Connecting the PARI Filter Valve Set with a jet nebuliser • Assemble the nebuliser as described in the instructions for use of the nebuliser. • Push the PARI Filter Valve Set onto the nebuliser. Connecting the PARI Filter Valve Set with a membrane nebuliser •...

  • Page 15: Ending The Treatment

    • Carry out the PEP treatment as described in the instructions for use of the PARI PEP S. 3.3 Ending the treatment End the treatment as described in the instructions for use of the nebuliser or the PARI PEP S system which you are using.

  • Page 16: Reprocessing In A Home Environment

    4.3 Preparation • Detach the PARI Filter Valve Set from the nebuliser. • Dismantle the PARI Filter Valve Set into all individual parts. • Dispose of the PARI filter pad. 4.4 Cleaning Precleaning All individual parts must be precleaned immediately after use.
  • Page 17 – 17 – Manual cleaning EQUIPMENT: – Drinking water temperature of at least 40 °C – Standard washing-up liquid – Receptacle with at least 3 l capacity PROCEDURE: • Add about 1 teaspoon of wash- ing-up liquid to 3 l warm drink- ing water. •...
  • Page 18 – 18 – 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 19: Disinfecting

    – 19 – 4.5 Disinfecting Disinfect all individual components after cleaning. Only com- ponents that have been cleaned can be disinfected effectively. The validated disinfection procedures are described below. In boiling water EQUIPMENT: – Clean saucepan – Drinking water PROCEDURE: CAUTION Risk of infection due to moisture Moisture encourages the growth of bacteria.
  • Page 20 – 20 – 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 prop- erly before every disinfection process. •...

  • Page 21: Inspecting

    After each cleaning and disinfection, place all components on a dry, clean and absorbent surface, and let them dry completely. 4.8 Storage Store your PARI Filter Valve Set as described below: • Wrap all individual components in a clean, lint-free cloth (e.g. a tea towel).

  • Page 22: Reprocessing In Professional Health Institutions

    – 22 – REPROCESSING IN PROFESSIONAL HEALTH INSTITUTIONS 5.1 Reprocessing cycles Single patient use PARI Filter Valve Set – Clean immediately after every use – Disinfect once a week Before a change of patient PARI Filter Valve Set – Cleaning –...

  • Page 23: Pari Filter Valve Set

    • Clean, disinfect and sterilise all separated parts before every patient change. All components of the PARI Filter Valve Set without PARI filter pad can be cleaned, disinfected and sterilised according to the procedures described below.
  • Page 24 – 24 – Cleaning and disinfecting Manual cleaning EQUIPMENT The method has been validated in Europe using: – pH-neutral, enzymatic cleaning agent: ® 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...
  • Page 25 – 25 – Cleaning with disinfection Cleaning and disinfection can be carried out in a single cycle using chemical reprocessing. To ensure safety when handling chemicals, observe the in- structions for use for the disinfectant. Mechanical EQUIPMENT: cleaning with The method has been validated in Europe using: disinfection: –...
  • Page 26 – 26 – 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 about 15 °C – Application time: 5 minutes PROCEDURE: •...
  • Page 27 – 27 – Chemical disinfection To ensure safety when handling chemicals, observe the in- structions for use for 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 28 Disinfectants can trigger allergic reactions or irritation of the mucous membrane on contact with the skin. • Rinse 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.
  • Page 29 – 29 – 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 30: Visual Inspection And Storage

    – 30 – 5.4 Visual inspection and storage Check all individual components. Replace any broken, de- formed or seriously discoloured parts. Storage location: – dry – dust-free – protected from sources of contamination optional: use sterile packaging FURTHER INFORMATION All product components may be disposed of with normal do- mestic waste.
  • Page 31 – 31 –...
  • Page 32 ©2022 PARI GmbH Spezialisten für effektive Inhalation, 041D3101 A en 2022-04-25   PARI GmbH Spezialisten für effektive Inhalation Moosstraße 3 82319 Starnberg • GERMANY info@pari.de • www.pari.com...

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