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Instructions for use
PARI SINUS2 nebuliser system
PARI SINUS2 compressor (Type 128)
®
PARI LC SPRINT
SINUS nebuliser (Type 023)
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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Table of Contents
Related Manuals for Pari SINUS2
Summary of Contents for Pari SINUS2
- Page 1 Instructions for use PARI SINUS2 nebuliser system PARI SINUS2 compressor (Type 128) ® PARI LC SPRINT SINUS nebuliser (Type 023) 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 SINUS2 nebuliser 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 questions 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...
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Page 5: Table Of Contents
Setting up the compressor ..........Preparing for treatment ............ Performing treatment............Ending the treatment ............REPROCESSING ............Single patient use ............. Multiple patient use ............Care of the PARI SINUS tubing system ......Replacing the air filter............Inspecting ................. Storage ................TROUBLESHOOTING ............. TECHNICAL DATA............Compressor .............. - Page 6 – 6 – MISCELLANEOUS ............Disposal................Links ................. Labelling ................APPENDIX: Reprocessing in professional environ- ments (for only one patient) .......... Compressor ..............Nebuliser ................PARI SINUS tubing system ..........
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Page 7: Important Information
Nebuliser The PARI LC SPRINT SINUS nebuliser generates aerosols for respiratory therapy. For reasons of hygiene, this PARI product must only be used in a home environment by a single patient. It is designed to treat patients from age 6 up to adult. Only solutions and suspensions that are approved for use in nebuliser therapy may be used. -
Page 8: Indication
The user must follow these in order to guarantee safe operation 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 – Danger of electrocution The compressor is an electrical device that is powered by sup- ply voltage. It has been designed so that no live parts are ac- cessible. However, if ambient conditions are unfavourable or if the compressor or power cord is damaged, this protection may no longer be provided.
- Page 10 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 11 – 11 – – Always use drinking water for cleaning and disinfecting. – Dry all product components completely after each cleaning and disinfection. – Do not keep the product components in a damp environ- ment or together with damp objects. Treatment of children and anyone who requires assistance For individuals who are not able to perform the therapy session...
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Page 12: Product Description
The following components are included in the package (these may differ from the picture on the packaging): 2e 2f (1) Compressor (2) PARI LC SPRINT SINUS nebuliser (2a) Nebuliser upper part (2b) Nozzle insert (orange) (2c) Nebuliser lower part (2d) Adapter for vibration... -
Page 13: Working Parts
– 13 – 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) Vibration connection... -
Page 14: Description Of Function
– 14 – 2.3 Description of function Aerosol (pulsating) Air inflow (pulsating) Compressed air The compressor supplies the nebuliser with compressed air. When compressed air is supplied, Air inflow the nebuliser generates an aero- (pulsating) sol from the liquid, for example the medication with which it is filled. -
Page 15: Material Information
Approx. 1,000 operating hours (this corresponds to max. 5 years) If the compressor is still in use after this time, have the compressor tested. To do this, contact the manufacturer or distributor. Nebuliser (all components 300 disinfections, max. 1 year except the PARI SINUS tubing system) PARI SINUS tubing system Max. 1 year... -
Page 16: Application
(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 17 – 17 – CAUTION Danger of injury from falling compressor A compressor placed in a poor position poses a risk of injury. • Do not place the compressor above head height. • Make sure that the compressor cannot be pulled down by the power cord or the connection tubes.
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Page 18: Preparing For Treatment
– 18 – 3.2 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 be- fore each use. - Page 19 – 19 – • Insert one tubing connector on the PARI SINUS tubing system in the bottom of the nebuliser. Filling the nebuliser NOTE Nebuliser lid might break off If the lid is twisted in the wrong direction, it may break off.
- Page 20 • Fill the nebuliser with the next inhalation solution as described. Connecting the tubes The PARI SINUS tubing system consists of two identical tubes. One tube is needed for the compressed air supply, the other helps to generate the vibration. To connect the tubing system up fully, proceed as follows: •...
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Page 21: Performing Treatment
– 21 – 3.3 Performing treatment All of the safety instructions in these instructions for use must have been read and understood before any treatment is carried out. Always hold the nebuliser upright during treatment. General instructions for use To ensure that the treatment has the desired effect, please fol- low the instructions below: –... - Page 22 • Make quite sure that the other ends of the tubes connec- ted to the compressor are attached to the PARI nebuliser. Proceed as follows in order to carry out the treatment: • Take the nebuliser out of its holder and hold it upright.
- Page 23 – 23 – • 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 fault is suspected (e.g., follow- ing a fall or if there is a smell of burning plastic).
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Page 24: Ending The Treatment
– 24 – After about 2.5 minutes, carry out the treatment as described for a further 2.5 minutes on the other nostril. The treatment is complete after 5 minutes in all. Some residual fluid will remain in the nebuliser after the end of the treatment. Reducing feeling of pressure If you feel an uncomfortable level of pressure while carrying out the therapy, reduce the pressure:... -
Page 25: Reprocessing
Cleaning and disinfection cycles Compressor housing Clean when visibly dirty Nebuliser (without – Cleaning immediately after every use. PARI SINUS tubing – Disinfection at least once a week. system) In the case of an acute infection or for high risk groups (e.g., cystic fibrosis patients) at least once a day. - Page 26 • Detach the adapter from the tube. • Dismantle the nebuliser into its individual parts. Cleaning The PARI SINUS tubing system cannot be cleaned or disin- fected. Regarding care of the tubing system, follow the in- structions in the corresponding section [see: Care of the PARI SINUS tubing system, page 30].
- Page 27 – 27 – CAUTION Risk of infection due to moisture Moisture encourages the growth of bacteria. • Remove all parts from the pot or disinfector as soon as the disinfection process is finished. • Dry all parts. IN BOILING WATER •...
- Page 28 – 28 – Drying After each cleaning and disinfection, place all product compon- ents on a dry, clean and absorbent surface and let them dry completely. Cleaning the compressor housing 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.
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Page 29: Multiple Patient Use
– 29 – 4.2 Multiple patient use Cleaning and disinfection cycles Nebuliser with Replace before each patient change PARI SINUS tube system Compressor housing Disinfect before each patient change Air filter Replace after 200 operating hours (approx. 1 year) Nebuliser The nebuliser is not suitable for use by more than one patient. -
Page 30: Care Of The Pari Sinus Tubing System
– 30 – 4.3 Care of the PARI SINUS tubing system Dry the PARI SINUS tubing system after every use: • Insert the matching tubing connector on the first of the two tubes in the compressed air connector on the compressor. • Switch the compressor on. -
Page 31: Inspecting
– 31 – 4.5 Inspecting Inspect all product components after each cleaning and disin- fection. Replace any broken, misshapen or seriously dis- coloured parts. 4.6 Storage Store this product as described below: • Wind the power cord up loosely. NOTE! Do not wind the power cord around the compressor. -
Page 32: 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 33: Technical Data
Degree of protection when used in the No protection presence of flammable mixtures of anaesthetics with air, with oxygen, or with nitrous oxide Operating mode Continuous operation 5) Towards nebuliser nozzle (Ø 0.48 mm). 6) Measured according to PARI measurement procedure. - Page 34 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...
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Page 35: Nebuliser
8 ml Aerosol data The aerosol characteristics of the PARI LC SPRINT SINUS nebuliser were determined using the PARI SINUS2 com- pressor. The particle size was measured with the “Next Gener- ation Impactor” (NGI). The measurement was carried out with 7) Without bend, nasal joining piece and adapter; unfilled. -
Page 36: Miscellaneous
– 36 – an ambient temperature of 23 °C and 50% relative humidity. 2 ml salbutamol (1 mg/1 ml) were nebulised. The Jet Flow was measured to be 4.6 l/min. Nominal com- pressor flow Nozzle insert (orange) (4.6 l/min – 1.5 bar) MMAD [µm] 2.18 Aerosol fraction [% > 5 µm] 66.6 Aerosol fraction [% < 2 µm] 28.7... -
Page 37: Links
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 38 – 38 – Serial number ON OFF On / Off Alternating current Protection class of the applied part: Type BF 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...
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Page 39: Appendix: Reprocessing In Professional Environments (For Only One Patient)
Ensure that no liquid gets into the device, as this might dam- age the device. Nebuliser The following overview of the processing steps in professional environments applies to the following products: – Nebuliser (all components except the PARI SINUS tubing system) 1. Preparation Disassemble the product [see: Preparation, page 26]. Check: –... - Page 40 – 40 – 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, ®...
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Page 41: Pari Sinus Tubing System
– dry – dust-free – protected from sources of contamination optional: Use sterile packaging Processing limits max. 300 disinfection cycles, max. 1 year PARI SINUS tubing system 1. Preparation Check the product: – Expiry date of the cleaning agent/disinfectant – Processing limits reached? 2. Cleaning and disinfection... - Page 42 – 42 – ® Mechanical Alkaline cleaning agent, e.g., neodisher cleaning with MediClean forte (Dr. Weigert) in conjunction with ® disinfection: neutralising agent, e.g., neodisher Z (Dr. Weigert) Equipment: – Cleaning device and disinfector in conform- ance with DIN EN ISO 15883, e.g., RDG G7836 CD (Miele) –...
- Page 43 PARI SINUS2 nebuliser system CERTIFICATE OF GUARANTEE We guarantee the compressor for 4 years. The warranty period commences on the date of purchase.
- Page 44 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, 128D2101_en-F 2020-02-05 PARI GmbH Spezialisten für effektive Inhalation Moosstraße 3 82319 Starnberg •...
- Page 45 Notice d'utilisation Système de nébulisation PARI SINUS2 Compresseur PARI SINUS2 (type 128) ® Nébuliseur PARI LC SPRINT SINUS (type 023) Important : lisez attentivement cette notice d'utilisation avant toute utilisation. Suivez toutes les instructions et les consignes de sécurité ! Conservez cette notice d'utilisation dans un endroit sûr.
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