Pari COMPACT2 Instructions For Use Manual
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Pari COMPACT2 Instructions For Use Manual

Inhalation system
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Instructions for use
PARI COMPACT2 inhalation system
PARI COMPACT2 compressor (Type 152)
®
PARI LC PLUS
nebuliser (Type 022)
PARI child mask soft (Type 041)
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.
en

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  • Page 1 Instructions for use PARI COMPACT2 inhalation system PARI COMPACT2 compressor (Type 152) ® PARI LC PLUS nebuliser (Type 022) PARI child mask soft (Type 041) 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 COMPACT2 inhalation systems in the following countries: Countries outside the EU Version of these instructions for use: Version F – 2020-02, Approved version dated 2019-11-21 Information as of: 2019-11...
  • 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...

  • Page 5: Table Of Contents

    – 5 – TABLE OF CONTENTS IMPORTANT INFORMATION.......... Intended purpose ............. Indication ................Contraindications.............. Safety instructions ............PRODUCT DESCRIPTION ..........Components ..............Working parts ..............Description of function ............Material information ............Maintenance ..............Operating life ..............APPLICATION ..............Setting up the compressor ..........Preparing for treatment ............
  • Page 6 – 6 – MISCELLANEOUS ............Disposal................Links ................. Labelling ................APPENDIX: Reprocessing in professional environ- ments for use with several patients ......Compressor ..............Nebuliser and accessories ..........Connection tubing ............

  • Page 7: Important Information

    Compressor The purpose of the PARI compressor is to generate com- pressed air for operating a PARI nebuliser. The PARI compressor is intended for use with multiple pa- tients. It must only be used for PARI nebulisers. The com- pressor can be operated by the patient himself and must only be used indoors.

  • 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 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 – 10 – – if it is suspected that the compressor or the power cord might have been damaged (e.g., after the compressor has fallen or if there is a smell of burning plastic) – if a malfunction occurs during operation –...
  • Page 11 – 11 – Impairment of treatment due to electromagnetic interference Use only original spare parts and original accessories from PARI. The use of third party products can result in increased emissions of electromagnetic interference or reduced resis- tance of the PARI compressor. Hygiene Observe the following hygiene instructions: –...
  • Page 12 – 12 – Identifying and classifying warning instructions Safety-critical warnings are categorised according to the follow- ing 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.

  • Page 13: Product Description

    PRODUCT DESCRIPTION 2.1 Components The following components are included in the package (these may differ from the picture on the packaging): (1) Compressor (2) PARI LC PLUS nebuliser (2a) Inspiratory valve (2b) Nozzle insert (transparent) (2c) Nebuliser lower part (2d) Mouthpiece (2e) Connection tubing (3) PARI child mask soft...

  • Page 14: Working Parts

    – 14 – 2.2 Working parts The compressor includes the following working parts: (1) Carrying handle (2) Power cord (connected inseparably to the compressor) (2a) Cable holder (3) Ventilation slits (4) Holder for nebuliser (5) Identification label (bottom of device) (6) Air connection (7) Air filter (8) On/off switch...

  • Page 15: Description Of Function

    – 15 – 2.3 Description of function Compressor with nebuliser Aerosol Compressed air The compressor supplies the nebuliser with compressed air. 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 16: Material Information

    Mouthpiece (with Polypropylene, thermoplastic elastomer exhalation valve) Connection tubing Polyvinyl chloride Tubing endpiece Thermoplastic elastomer PARI child mask soft Polypropylene, thermoplastic elastomer Elastic band Synthetic rubber 2.5 Maintenance The compressor is maintenance free. 2.6 Operating life The individual product components have the following expec-...

  • Page 17: Application

    People who assist others in carrying out the therapy must en- sure 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 18 (including accessories there- for, such as antenna cables or external antennas). • If the PARI device has to be placed immediately beside or on top of other devices for operation, all devices must be monitored to ensure that they are working properly.

  • Page 19: Preparing For Treatment

    – 19 – Set the compressor up as follows: • Place the compressor on a firm, flat, dust-free, dry surface. • Plug the power plug into a suitable socket.  CAUTION! Route the power cord in such a way that it is not a tripping hazard and no one can become entangled in it.
  • Page 20 – 20 – • Attach the connection tubing to the nebuliser. Using the mouthpiece • Fit the mouthpiece onto the nebuliser. Using the mask • If desired, attach the elastic band to the mask (as shown in the figure).
  • Page 21 – 21 – • If applicable, detach the mouthpiece from the nebuliser. • Attach the mask to the nebuliser. Filling the nebuliser • Insert the nebuliser in the holder on the compressor in- tended for this purpose. • If applicable, detach the inspiratory valve from the nebuliser. •...

  • Page 22: Performing Treatment

    – 22 – If several inhalation solutions are to be used one after the other: • Rinse the nebuliser out with drinking water between the indi- vidual applications. • Shake excess water out of the nebuliser. • Fill the nebuliser with the next inhalation solution as described.
  • Page 23 – 23 – • Take the nebuliser out of its holder and hold it upright. • Verify that all parts are firmly connected to each other. • Switch the compressor on.  DANGER! Danger of death by electrocution in the case of device fault! Switch the compressor off and discon- nect the power plug from the mains socket immediately if a...
  • Page 24 – 24 – • Carry out the inhalation treatment until the noise in the nebuliser changes. Some residual fluid will remain in the nebuliser after the end of the treatment. Inhaling with the mask CAUTION Impaired treatment due to escaping aerosol If the mask does not form a seal on the face, aerosol may escape.

  • Page 25: Ending The Treatment

    – 25 – Teach the child to perform the following inhalation manoeuvre: • Breathe in as slowly and deeply as possible through the mask and out again calmly. • Continue inhaling until the noise in the nebuliser changes. Some residual fluid will remain in the nebuliser after the end of the treatment.

  • Page 26: Reprocessing

    – 26 – REPROCESSING DANGER Danger of electrocution Liquids can conduct electricity, thereby posing a risk of elec- tric shock. • Always switch the compressor off and disconnect the power plug from the mains socket before starting to clean it. If the inhalation system is used by only one patient, follow the instructions for cleaning and disinfecting in the section "Single patient use"...
  • Page 27 – 27 – NEBULISER • Detach the tube from the nebuliser. • Detach the mouthpiece from the nebuliser. • Make sure that all residual volume is removed from the nebuliser. • Dismantle the nebuliser into its individual parts. • Carefully pull the blue exhala- tion valve out of the slot in the mouthpiece.
  • Page 28 – 28 – 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 be- low. Descriptions of other validated disinfection procedures are available from the manufacturer or dealer upon request. The connection tube cannot be cleaned or disinfected.
  • Page 29 – 29 – 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 prop- erly before every disinfection process.

  • Page 30: Multiple Patient Use

    – 30 – Clean the compressor housing as follows: • Wipe the outer surface of the housing with a clean, damp cloth. 4.2 Multiple patient use Cleaning and disinfection cycles Nebuliser (with Replace before each patient change connection tubing) and mask Compressor housing Disinfect before each patient change...

  • Page 31: Care Of The Connection Tube

    – 31 – • If the compressor is visibly dirty, clean the compressor before disinfecting it [see: Cleaning the compressor housing, page 30]. • Moisten a cloth with the disinfectant. NOTE! Danger of device fault due to liquid penetration. Never spray any liquids onto the compressor or the power cord.

  • Page 32: Inspecting

    – 32 – Replace the air filter: • Pull the old air filter out of the filter holder and fit the new fil- ter in its place. NOTE! Only use air filters provided by the manufacturer or dealer for operating your compressor. If air filters that are not designed for the compressor are used, the compressor may be damaged.

  • Page 33: Troubleshooting

    The compressor must not be repaired except by the Technical Service of PARI GmbH or a service center expressly authorised to do so by PARI GmbH. If the compressor is opened or manipulated by anyone else, all claims under the warranty shall be void. In these cases, PARI GmbH will accept no liability.
  • Page 34 – 34 – Housing dimensions 18.5 cm × 13.0 cm × 15.0 cm (W × H × D) Weight 1.55 kg Pressure 1.2 bar Compressor flow 4.1 l/min Sound pressure level 56 dB(A) Classification according to IEC 60601-1 / EN 60601-1 Type of electric shock protection Protection class II Degree of protection from electric shock of Type BF the applied part (nebuliser) Degree of protection according to IEC 60529 / IP 21 EN 60529 against penetration by water and...
  • Page 35 Technical data on electromagnetic compatibility (EMC informa- tion) is available in table format upon request from the manu- facturer or dealer or on the internet at the following linked page: https://www.pari.com/fileadmin/Electromagnetic-compatibility-5.pdf Ambient conditions During operation Ambient temperature +10 °C to +40 °C...

  • Page 36: Nebuliser

    27.5 g to 29.5 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; PARI LC STAR: 6 ml 6) Without mouthpiece and mask; unfilled.
  • Page 37 [% > 5 µm] Aerosol output [ml] 0.30 0.40 0.38 Aerosol output rate 0.09 0.12 0.14 [ml/min] Residual volume 1.28 1.15 1.14 [ml] (gravimetric) 7) Operation with PARI COMPACT2 compressor (Type 152). 8) MMAD = Mass Median Aerodynamic Diameter 9) GSD = Geometric Standard Deviation...

  • Page 38: Miscellaneous

    All other product components All other product components included in your PARI inhalation system can be disposed of with domestic waste unless other regulations apply in the country where you are located.

  • Page 39: Links

    – 39 – 7.2 Links Warranty conditions: Technical data regarding electro- www.pari.com/ magnetic compatibility: warranty-conditions https://www.pari.com/fileadmin/ Electromagnetic-compatibility-5.pdf 7.3 Labelling The following symbols can be found on the product compon- ents and/or the packaging: This product satisfies the requirements of 93/42/EEC (Medical devices) and 2011/65/EU (RoHS).
  • Page 40 – 40 – Protection class II device The device is protected against drip water (degree of protection according to IEC 60529 / EN 60529). Temperature limit Humidity, limit Air pressure, limit Legal manufacturer...

  • Page 41: Appendix: Reprocessing In Professional Environments For Use With Several Patients

    Nebuliser and accessories The following overview of the processing steps in professional environments applies to the following products: – Nebuliser – PARI child mask soft (without elastic band) 1. Preparation Disassemble the product [see: Preparation, page 26]. Check: – Expiry date of the cleaning agent/disinfectant...
  • Page 42 – 42 – 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 disinfectant, ®...
  • Page 43 – 43 – 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 – Mask stabiliser Temperature / Duration: 134 °C for at least 3 min. Info: Always use the mask stabil- iser when sterilising because oth- erwise it may lose its shape under...

  • Page 44: Connection Tubing

    – 44 – 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 45 – 45 – Processing limits max. 50 processing cycles...
  • Page 46 – 46 –...
  • Page 47 PARI COMPACT2 inhalation system CERTIFICATE OF GUARANTEE We guarantee the compressor for 2 years. The warranty period commences on the date of purchase.
  • Page 48 The product with the serial number stated above was sold in its original packaging by us. Date of purchase Stamp and signature of the dealer ©2020 PARI GmbH Spezialisten für effektive Inhalation, 152D2102_en-F 2020-02-07   PARI GmbH Spezialisten für effektive Inhalation Moosstraße 3 82319 Starnberg •...
  • Page 49 Instrucciones de uso Sistema de inhalación PARI COMPACT2 Compresor PARI COMPACT2 (Tipo 152) ® Nebulizador PARI LC PLUS (Tipo 022) Mascarilla pediátrica soft PARI (Tipo 041) Importante: Antes de utilizar el producto lea detenidamente estas instrucciones de uso. Atención: respete todas las ins- trucciones y la información sobre seguridad.

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