Pari PEP S System Instructions For Use Manual
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Pari PEP S System Instructions For Use Manual

Pep therapy system
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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

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Summary of Contents for Pari PEP S System

  • 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...
  • Page 2 These instructions for use describe the components of PARI products and optional ac- cessories. 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 op- tional. When using the systems, products and functions, the applicable country-specific regu- lations must be observed.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS IMPORTANT INFORMATION ..............5 Intended purpose.....................5 Indication .........................5 Contraindication.......................5 Labelling ........................6 Safety and warning instructions................7 PRODUCT DESCRIPTION ................ 9 Components ......................9 Overview and designations ..................9 Product combinations....................9 Description of function...................10 Material information....................11 Calibration ......................11 Operating life ......................11 USE......................
  • Page 4 REPROCESSING IN PROFESSIONAL HEALTH INSTITUTIONS ..... 21 Reprocessing cycles....................21 Processing limits....................21 PARI PEP S System....................22 Connection tubing....................28 Visual inspection and storage................28 TECHNICAL DATA ................. 29 FURTHER INFORMATION ..............29...

  • Page 5: Important Information

    – by children aged 10 and older and adults after informed instruction This PARI product can be used in a home environment, as well as in professional health in- stitutions. When used in a home environment, this PARI product is intended for single-pa- tient use only (no patient change).

  • Page 6: Labelling

    1.4 Labelling The following symbols can be found on the product and/or the packaging: Medical device Legal manufacturer Date of manufacture Item no. Production batch number, lot number Unique Device Identifier (UDI) This product conforms to the EU Medical Device Regulation 2017/745. Consult instructions for use Mouthpiece without expiratory valve Connecting element...

  • Page 7: Safety And Warning Instructions

    The user must follow these in order to guarantee safe operation of this PARI product. This PARI product must be used only as described in these instructions for use. When the system is used in combination therapy, the instructions for use of the nebuliser and compressor used must also be followed.
  • Page 8 General The PARI PEP S system must not be used without first receiving instruction from a health- care professional If your health condition does not improve or it even worsens as a result of the treat- ment, seek professional medical advice. Treatment of babies, infants, and anyone who requires assistance...

  • Page 9: Product Description

    Tubing adapter Connection tubing Pressure gauge connector line 2.3 Product combinations The PARI PEP S system can be used with: – Nebulisers: PARI LC PLUS, PARI LC STAR, PARI LC SPRINT, PARI LC SPRINT Junior, PARI LC SPRINT STAR, PARI LC SPRINT COMPACT, PARI LC SPRINT SP, and PARI LL – Pressure gauge – PARI Filter/Valve Set The PARI PEP S System cannot be used with masks.

  • Page 10: Description Of Function

    PEP therapy on each occasion. – Use of the PEP S System for children. The pressure gauge helps parents when monitoring the correct implementation of the PEP therapy of their child. The pressure gauge allows the parents to check at any time whether the child is undergoing the PEP therapy in the optimum pressure range.

  • Page 11: Material Information

    The pressure gauge should be calibrated every three years. For this, please contact PARI GmbH. 2.7 Operating life The individual product components have the following expected lifetimes: Product component Service life PARI PEP S System, con- in home environment [see: REPROCESSING IN A HOME nector line, tubing adapter, ENVIRONMENT, page 16] connection tubing PARI PEP S System, con- in professional environment [see: REPROCESSING IN...

  • Page 12: Use

    3.1 Preparing for treatment • Close the PEP S connecting element securely using the cap. Adjusting expiratory resistance • Push the PEP S adjusting ring onto the PEP S con- necting element. • Align the adjusting ring so that the hole with the dia- meter recommended by your doctor or therapist is po- sitioned over the hole in the connecting element.
  • Page 13  CAUTION! Risk of infection due to contamin- ation! If the connection tubing is connected directly to the PARI PEP S System, germs may build up in the tubing. Since the connection tubing cannot be disin- fected, use the pressure gauge exclusively with the extra pressure gauge connector line and the tubing adapter, in order to avoid a risk of infection.

  • Page 14: Performing Treatment

    The exhaled air should pass through the hole in the PEP S adjusting ring. • Cough to clear any secretion that is loosened during the treatment. For reasons of hygiene, avoid coughing into the PARI PEP S System. • Continue the PEP therapy session for the period recommended by your doctor or physio-...
  • Page 15 If the PEP therapy is to be terminated before the end of the nebuliser therapy, then the com- bination therapy can be paused and the PARI PEP S System can be replaced by the mouth- piece with exhalation valve or a mask. To do this, proceed as follows: •...

  • Page 16: Reprocessing In A Home Environment

    • Detach the tubing adapter from the pressure gauge connector line and the connection tubing. General: • If necessary, disconnect the PARI PEP S system from the nebuliser. • Dismantle the PARI PEP S system into its individual parts. • Open the cap on the connecting element.

  • Page 17: Cleaning

    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 temperature of about 40 °C –...

  • Page 18: Disinfecting

    In the dishwasher To ensure safety when handling the cleaning agent used, follow the corresponding instruc- tions for use, particularly the accompanying safety instructions. The individual parts can be cleaned in a standard household dishwasher provided it is con- nected to a mains water supply of drinking water quality. PROCEDURE: Do not clean the individual components together with very dirty dishes.

  • Page 19: Care Of The Pressure Gauge And Connection Tubing

    Using a standard thermal disinfector for baby bottles (not a microwave oven) EQUIPMENT: – Thermal disinfector with a runtime of at least 6 minutes. PROCEDURE: CAUTION Risk of infection due to inadequate disinfection Inadequate disinfection encourages the growth of bacteria and thus increases the risk of infection.

  • Page 20: Drying

    4.8 Drying After each cleaning and disinfection, place all product components on a dry, clean and ab- sorbent surface and let them dry completely. 4.9 Storage Store this product as described below: • Wrap all individual components in a clean, lint-free cloth (e.g. a tea towel). •...

  • Page 21: Reprocessing In Professional Health Institutions

    INSTITUTIONS Dry the connection tubing after each use [see: Connection tubing, page 28]. 5.1 Reprocessing cycles Single patient use PARI PEP S System – Clean immediately after every use – Disinfect once a week Before a change of patients PARI PEP S System –...

  • Page 22: Pari Pep S System

    • Replace the connection tubing or carry out mechanical cleaning and disinfection of the connection tubing [see: Connection tubing, page 28]. All components of the PARI PEP S System can be cleaned, disinfected and sterilised ac- cording to the procedures described below. The connection tubing must be treated separately.
  • Page 23 PROCEDURE: CAUTION Risk of infection 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 specified treatment time. • Ensure that all components are completely submerged in the solution for the whole of the treatment time.
  • Page 24 Cleaning with disinfection To ensure safety when handling chemicals, follow the instructions for use of the disinfectant. Mechanical cleaning EQUIPMENT: with disinfection: The method has been validated in Europe using: – Alkaline cleaning agent: ® Dr. Weigert neodisher MediClean forte (concentration: 0.5%) –...
  • Page 25 Chemical cleaning EQUIPMENT: with disinfection: The method has been validated in Europe using: ® – Aldehyde-free instrument disinfectant: Bode Bomix  plus (concen- tration: 2%) Active agent basis: Quaternary ammonium compound – Application time: 5 minutes PROCEDURE: • Clean and disinfect the individual parts in a single work step with a solution prepared according to the manufacturer’s instructions.
  • Page 26 • Rinse the product thoroughly to ensure that no residues of the disinfectant remain on the PARI product. • Rinse off all parts thoroughly in running water at about 15 °C for 3 minutes. • Dispose of the used solution. The diluted solution can be disposed of down the drain.
  • Page 27 Sterilising CAUTION Risk of infection by residual germs If there is dirt on the parts, germs capable of reproduction may remain despite the steril- isation process. As a result, there is a danger of infection. • Clean, disinfect, and dry all parts thoroughly before sterilising. •...

  • Page 28: Connection Tubing

    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 29: Technical Data

    TECHNICAL DATA Expiratory pressure in mbar Air flow [L/min] Dimensions and weights PEP S Pressure gauge Dimensions 13x3x5.3 8x6x4 LxWxH [cm] Weight [g] 14.7 107.1 FURTHER INFORMATION All product components may be disposed of with normal domestic waste. The country-spe- cific disposal regulations must be observed.
  • Page 32   PARI GmbH Spezialisten für effektive Inhalation Moosstraße 3 82319 Starnberg • GERMANY info@pari.de • www.pari.com ©2023 PARI GmbH Spezialisten für effektive Inhalation, 018D2001-G en 2023-07-19...

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