Pari PEP S System Instructions For Use Manual
  1. Manuals
  2. Brands
  3. Pari Manuals
  4. Personal Care Products
  5. PEP S
  6. Instructions for use manual

Pari PEP S System Instructions For Use Manual

Hide thumbs Also See for PEP S System:
Table of Contents

Advertisement

Quick Links

Download this manual
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

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the PEP S System and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Pari PEP S System

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 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 ................Contraindication ............... Labelling ................Safety and warning instructions ........PRODUCT DESCRIPTION ..........Components ..............Overview and designations ..........Product combinations ............Description of function ............Material information ............Calibration ................
  • Page 4 – 4 – REPROCESSING IN PROFESSIONAL HEALTH INSTI- TUTIONS................Reprocessing cycles ............Processing limits .............. PARI PEP S System ............Connection tubing ............Visual inspection and storage .......... FURTHER INFORMATION ..........

  • Page 5: Important Information

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

  • Page 6: Contraindication

    – 6 – 1.3 Contraindication The PARI PEP S System must not be used by individuals who are suffering from untreated pneumothorax or massive hae- moptysis. 1.4 Labelling The following symbols can be found on the product and/or the packaging: Medical device Legal manufacturer...

  • Page 7: Safety And Warning 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. When the system is used in combination therapy, the instruc- tions for use of the nebuliser and compressor used must also be followed.
  • Page 8 – 8 – General The PARI PEP S system must not be used without first receiv- ing instruction from a healthcare professional If your health condition does not improve or it even wor- sens as a result of the treatment, seek professional med- ical advice.
  • Page 9 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 10: Product Description

    – 10 – PRODUCT DESCRIPTION 2.1 Components Please refer to the package for information on the supplied components. 2.2 Overview and designations 6c 6d (1) Connecting element (2) Adjusting ring (3) Inhalation valve (4) Mouthpiece (without exhalation valve) (5) Nose clip (6) Pressure gauge 0 to 100 mbar (6a) Pressure gauge (6b) Tubing adapter...

  • Page 11: Product Combinations

    PEP therapy In PEP therapy, expiratory resistance when exhaling is in- creased by the different sizes of the holes in the PARI PEP S System (the smaller the hole, the greater the resistance). The increased expiratory resistance has the effect of stabilising the airways and stimulating mucus dissolution.

  • Page 12: Material Information

    The greater the pressure, the greater the expiratory resistance. The pressure gauge makes it possible to adjust the desired ex- piratory resistance on the PARI PEP S System and to monitor it during PEP therapy. The pressure gauge is connected to the PARI PEP S System by tubes.

  • Page 13: Calibration

    Connection tubing Polyvinyl chloride Tubing connector Thermoplastic elastomer 2.6 Calibration 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 expec- ted lifetimes: Product component Service life PARI PEP S System,...

  • Page 14: Use

    – 14 – All the steps described below must be carried out properly. 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 connecting element. •...
  • Page 15 – 15 – PEP therapy • Insert the PEP S inhalation valve in the connecting ele- ment. • Insert the mouthpiece (without exhalation valve) on the other side of the connecting element. Info: Make sure that the blue in- halation valve washer is seated correctly.

  • Page 16: Performing Treatment

    •  CAUTION! Risk of infec- tion due to contamination! If the connection tubing is con- nected directly to the PARI PEP S System, germs may build up in the tubing. Since the connection tubing cannot be disinfected, 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 17 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 recommen- ded by your doctor or physiotherapist.
  • Page 18 If the PEP therapy is to be terminated before the end of the nebuliser therapy, then the combination 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 19: Reprocessing In Home Environments

    – Disinfect once per week Cleaning and disinfection can be carried out together with the nebuliser. Pressure gauge Care as required [see: Care of the pressure gauge and connection tubing, page 24]. 4.2 Processing limits PARI PEP S System, 300 processing cycles, disinfection max. 1 year...

  • Page 20: Preparation

    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. 4.4 Cleaning Precleaning All individual parts must be precleaned immediately after use.
  • Page 21 – 21 – PROCEDURE: • Add about 1 teaspoonful 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. • In case of visible soiling, use a medium-soft brush (e.g. a toothbrush) which is used exclusively for this purpose.

  • Page 22: Disinfecting

    – 22 – DRYING: Ensure that there is no residual moisture remaining in the com- ponents. If necessary: • Shake the water out of all of the parts. • Place all parts on a dry, clean and absorbent surface, and allow them to dry completely.
  • Page 23 – 23 – DRYING: • Shake the water out of all of the parts. • Place all parts on a dry, clean and absorbent surface, and allow them to dry completely. Using a standard thermal disinfector for baby bottles (not a microwave oven) EQUIPMENT: –...

  • Page 24: Care Of The Pressure Gauge And Connection Tubing

    – 24 – 4.6 Care of the pressure gauge and connection tubing Wipe the pressure gauge and connection tubing with a damp cloth as necessary. If the connection tubing is visibly soiled, replace it. 4.7 Inspecting Inspect all product components after each cleaning and disin- fection.

  • Page 25: Reprocessing In Professional Health Institutions

    Dry the connection tubing after each use [see: Connection tubing, page 33]. 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 26: Pari Pep S System

    • Replace the connection tubing or carry out mechanical cleaning and disinfection of the connection tubing [see: Connection tubing, page 33]. All components of the PARI PEP S System can be cleaned, disinfected and sterilised according to the procedures de- scribed below. The connection tubing and elastic band of the mask must be treated separately.
  • Page 27 – 27 – 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 28 – 28 – 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 29 – 29 – 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 30 – 30 – 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 31 • 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 32 – 32 – 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 33: Connection Tubing

    – 33 – 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 34: Further Information

    – 34 – FURTHER INFORMATION All product components may be disposed of with normal do- mestic waste. The country-specific disposal regulations must be observed.
  • Page 35 – 35 –...
  • Page 36 ©2021 PARI GmbH Spezialisten für effektive Inhalation, 018D2000_en E 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:

018

Table of Contents