Pari BOY Classic Instructions For Use Manual

Pari BOY Classic Instructions For Use Manual

Inhalation system for the treatment of the lower airways
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Instructions for use
®
PARI BOY
Classic inhalation system
®
Model: PARI BOY
 Classic compressor (Type 130)
Model: PARI LC SPRINT
Model: PARI mask soft (Type 041)
PARI inhalation system for the treatment of the lower airways
®
nebuliser (Type 023)
en

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Summary of Contents for Pari BOY Classic

  • Page 1 Instructions for use ® PARI BOY Classic inhalation system ® Model: PARI BOY  Classic compressor (Type 130) ® Model: PARI LC SPRINT nebuliser (Type 023) Model: PARI mask soft (Type 041) PARI inhalation system for the treatment of the lower airways...
  • Page 2: Warranty

    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 .........................6 Contraindication.......................6 Labelling ........................7 Safety and warning instructions................8 PRODUCT DESCRIPTION ..............12 Components ......................12 Overview and designations ...................12 Working parts ......................13 Description of function...................14 Material information....................15 Maintenance......................15 Service life......................16 USE......................17 Setting up the compressor..................17 Preparing for treatment..................19 Performing treatment.....................22...
  • Page 4 TROUBLESHOOTING................37 TECHNICAL DATA ................. 38 Compressor......................38 Nebuliser .......................40 FURTHER INFORMATION ..............42 Disposal.........................42 Links ........................42...
  • Page 5: Important Information

    IMPORTANT INFORMATION Intended purpose The PARI inhalation system consists of a PARI compressor, a PARI nebuliser and PARI ac- cessories. The system is used to treat the lower airways. This product can be used in a home environment, as well as in professional health institu- tions.
  • Page 6: Indication

    The nebuliser must only be connected with a PARI compressor or with a central gas supply system. The PARI CENTRAL is intended for the connection with the central gas supply sys- tem. An application takes approximately 5 to 10 minutes (depending on the quantity of fluid), but in any case no more than 20 minutes.
  • Page 7: Labelling

    The symbol of the refuse bin with a cross through it indicates that it must be disposed of sep- arately. On/Off PARI BOY compressor Air filter for compressor type 130 Tubing adapter PARI adult mask soft...
  • Page 8: 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. The instructions for use of the inhalation solution used must also be followed.
  • Page 9 General If non-approved solutions or suspensions are used for nebulisation, then nebuliser aerosol characteristics may differ from the information provided by the manufacturer. This product is not suitable for use in an anaesthetic breathing system or a ventilator breath- ing system. Tracheotomised patients cannot inhale using a mouthpiece.
  • Page 10 – before cleaning and maintaining the device – immediately after use – Keep the power cord away from domestic animals (e.g. rodents). They may damage the insulation on the power cord. Danger of a device defect To avoid a device defect, comply with the following instructions: –...
  • Page 11 Keep all components of the product out of the reach of babies and infants at all times. 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 inter- ference resistance of the PARI compressor.
  • Page 12: Product Description

    PRODUCT DESCRIPTION Components Please refer to the package for information on the supplied components. Overview and designations 1 Compressor 2 Nebuliser Nebuliser upper part Nozzle attachment Nebuliser lower part Mouthpiece (with exhalation valve) Tubing adapter Connection tubing 3 Mask Elastic band...
  • Page 13: Working Parts

    Working parts The compressor includes the following working parts: Carrying handle Power cord (connected inseparably to the compressor) Cable holder Ventilation slits Holder for nebuliser Identification label (bottom of device) Compressed air connection Air filter On/off switch 4) The power plug type is country-specific. The figure shows the europlug (type "C").
  • Page 14: Description Of Function

    Liquid Compressed air In combination with a mouthpiece or a suitable mask, the PARI LC SPRINT nebuliser (Type 023) is a suitable therapy for patients in all age groups. The nozzle attachments de- scribed below are particularly suitable for the specified age groups.
  • Page 15: Material Information

    The PARI child and adult mask soft can be fixed to the face using the elastic band. The elastic band is attached to the loops on the side of the mask.
  • Page 16: Service Life

    When the expected operating life has been reached, replace the affected component. Re- placement sets or PARI Year Packs (a nebuliser with connection tubing and an air filter for a compressor) are available.
  • Page 17: Use

    • The PARI CENTRAL O2 is no longer sold. • If you use a PARI CENTRAL O2 which is still on the market, perform the treatment us- ing oxygen only after consultation with, and under the supervision of, a professional.
  • Page 18 CAUTION Impairment to quality of treatment caused by electromagnetic interference Electrical devices can cause electromagnetic interference. Interference can impair the function of the devices and thus also the effectiveness of the treatment. • Do not place the device immediately beside or on top of other devices. •...
  • Page 19: Preparing For Treatment

    Preparing for treatment Assembling the nebuliser CAUTION Risk of impaired treatment Damaged components and/or an incorrectly assembled nebuliser may impair functioning of the nebuliser and thus treatment as well. • Check all nebuliser components and the accessories before each use. •...
  • Page 20 Preparing the inhalation therapy USING THE MOUTHPIECE • Fit the mouthpiece onto the nebuliser. USING THE MASK • If necessary, attach the elastic band to the mask. • Attach the mask to the nebuliser.
  • Page 21 Filling the nebuliser NOTE Nebuliser lid might break off If the cap is twisted in the wrong direction, it may break off. The nebuliser will then be un- usable and irreparable. • Never move the lid except in the direction allowed by the hinge. •...
  • Page 22: Performing Treatment

    Performing treatment All the safety instructions and warnings in these instructions for use must have been read and understood before any treatment is carried out. Always hold the nebuliser upright during treatment. • If necessary, use the tubing adapter to connect the connection tubing and the compressor.
  • Page 23: Inhalation Therapy

    • Check that an aerosol is being generated (a fine mist is escaping from the nebuliser) be- fore 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, con- trolled inhalation technique. This improves uptake of the active agent in the lower airways.
  • Page 24 • Take note of possible side effects caused by escaping aerosol. These are described in the information for use of the respective medication. With PARI child or adult mask soft • Check whether the exhalation valve is pressed out- wards, to ensure that the user can breathe out freely during the inhalation session.
  • Page 25: Ending The Treatment

    Ending the treatment • Switch the compressor off by shifting the on/off switch to "OFF”. • Place the nebuliser back in the holder on the compressor. • Disconnect the power plug from the mains socket. Complete disconnection from the mains is only certain when the power plug has been unplugged from the socket.
  • Page 26: Reprocessing

    REPROCESSING CAUTION Risk of infection due to cross-contamination in the case of a change in patients If a product is used for more than one patient, there is a risk that germs may be transmit- ted from one patient to the next. •...
  • Page 27: Reprocessing Cycles

    Replace after 200 operating hours (approx. 1 year) 5) For the therapy of patients at risk, disinfect the individual parts once per day. Take note of the additional information for patients at risk [see: Reprocessing for patients at risk, page 28]. 6) Air filters are included in every PARI Year Pack.
  • Page 28 Reprocessing cycles in professional healthcare institution SINGLE PATIENT USE – Clean immediately after every use Nebuliser components – Disinfect once per week – Clean immediately after every use Mask components – Disinfect once per week Elastic band Cleaning visible dirt Compressor housing Cleaning visible dirt Air filter...
  • Page 29: Limits Of Reprocessing

    Limits of reprocessing Limits of reprocessing in a home environment Nebuliser and accessories, disinfection 300 processing cycles, max. 1 year Mask, disinfection 300 processing cycles, max. 1 year Limits of reprocessing in a professional healthcare institution Nebuliser and accessories, disinfection 300 reprocessing cycles, max. 1 year Nebuliser and accessories, sterilisation 100 processing cycles, max. 1 year 50 reprocessing cycles, Connection tubing...
  • Page 30: Reprocessing Of Nebuliser And Mask

    Reprocessing of nebuliser and mask The following products can be cleaned, disinfected and sterilised according to the procedure described below: – PARI nebuliser and PARI accessories – PARI mask soft The connection tubing and elastic band of the mask must be treated separately.
  • Page 31 Procedure A - Thermal disinfection using boiling water EQUIPMENT: – Clean cooking pot – Drinking water PROCEDURE: • Place all the individual parts in water at a rolling boil for at least 5 minutes. B - Using a standard thermal disinfector for baby bottles EQUIPMENT: –...
  • Page 32 Sterilisation temperature and holding time: – Temperature: 134 °C – Holding time: minimum 3 minutes to maximum 5 minutes Information on sterilising a PARI mask soft: Always use the corresponding mask stabiliser when sterilising this mask type, because other- wise the mask may lose its shape under the ef- fects of high temperatures.
  • Page 33: Reprocessing The Compressor

    Reprocessing the compressor DANGER Life-threatening situation from electrocution Liquids can conduct electricity, thereby posing a risk of electric shock. • Before starting to clean the compressor, always switch it off, and disconnect the power plug from the mains socket. NOTE Danger of device fault due to liquid penetration If liquids get into the interior of the compressor, this may cause a fault in the device.
  • Page 34 Procedure • Inspect all product components after each cleaning and disinfection. • Replace defective, deformed or seriously discoloured parts. The air filter must be checked at regular intervals (after every 10th use). If it is dis- coloured brown or grey, or if it is damp or clogged, it must be replaced. The air filter cannot be cleaned and then reused! Removing the air filter •...
  • Page 35: Reprocessing The Connection Tubing

    Reprocessing the connection tubing Dry the connection tubing after each use. The maximum operating life of the connection tubing is 1 year. Procedure EQUIPMENT: The method has been validated in Europe using: ® – Neodisher MediClean forte (concentration: 0.5%) – Deionised water –...
  • Page 36: Further Information About Reprocessing

    Further information about reprocessing Further validated processes for reprocessing The instructions provided were validated by PARI and were found to be suitable for prepar- ing your medical device for its reuse. Further validated processes for reprocessing: https://www.pari.com/fileadmin/041D0624_Professional_healthcare_insti- tution_Validated_Reprocessing_Methods.pdf Ensure that the reprocessing actually performed by your personnel on your equipment with the chemicals used achieves the desired results.
  • Page 37: Troubleshooting

    The compressor must be repaired only by PARI GmbH Technical Service or a service loca- tion expressly authorised to do so by PARI GmbH. If the compressor is opened or manipu- lated by anyone else, all claims under the warranty shall be void. In these cases, PARI GmbH will accept no liability.
  • Page 38: Technical Data

    TECHNICAL DATA Compressor General compressor data Supply voltage 220 – 240 V Mains frequency 50 Hz Power consumption 0.95 A Housing dimensions (W × H × D) 18.5 cm × 13.0 cm × 15.0 cm Weight 1.7 kg Pressure 1.6 bar Compressor flow 5.0 l/min. Sound pressure level 54 dB(A) Classification as per IEC 60601-1/EN 60601-1 Type of electric shock protection Protection class II Degree of protection from electric shock from the application Type BF...
  • Page 39: Electromagnetic Compatibility

    Electromagnetic compatibility Electrical medical equipment is subject to special precautionary measures with regard to electromagnetic compatibility (EMC). Such equipment must be installed and operated only in accordance with the electromagnetic compatibility instructions. Portable and mobile high-frequency communication devices can disrupt electrical medical equipment.
  • Page 40: Ambient Conditions

    Ambient conditions DURING OPERATION Ambient temperature +10 °C to +40 °C Relative humidity 30% to 75% (non-condensing) Atmospheric pressure 700 hPa to 1,060 hPa The compressor is intended for operation in all healthcare situations. It is not permitted to operate it in trains, motor vehicles or aeroplanes. Use of the compressor in professional healthcare facilities is limited to the inpatient wards and the intensive care unit.
  • Page 41 Aerosol output rate [ml/ 0.07 0.16 0.18 min] Residual volume [ml] (gra- 1.16 1.16 1.10 vimetric) Percentage of fill volume emitted per minute [%/min] 9) Operation with PARI BOY compressor (Type 130). 10) MMAD = Mass Median Aerodynamic Diameter 11) GSD = Geometric Standard Deviation...
  • Page 42: Further Information

    Links Terms and conditions of warranty: Technical data regarding electromagnetic compatibility: https://www.pari.com/int/warranty-conditions https://www.pari.com/fileadmin/041D0623-Electro- magnetic-compatibility-EMV.pdf PARI inhalation systems in aircraft: https://www.pari.com/fileadmin/041D0625_Airplane_Certificate_Jet_nebuliser.pdf 12) Directive 2012/19/EU of the EUROPEAN PARLIAMENT AND THE EUROPEAN COUNCIL of July 4, 2012 on waste electrical and electronic equipment.
  • Page 44   PARI GmbH Spezialisten für effektive Inhalation Moosstraße 3 82319 Starnberg • GERMANY info@pari.de • www.pari.com ©2024 PARI GmbH Spezialisten für effektive Inhalation, 130D2801-G en 2024-04-19...

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