Pari eflow rapid Instructions For Use Manual
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- Instructions for use manual (494 pages) ,
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Summary of Contents for Pari eflow rapid
- Page 1 nebuliser system Instructions for use Használati utasítás Notkunarleiðbeiningar Instrukcja obs ugi Kasutusjuhend Navodila za uporabo Upute za uporabu Kullan m talimatlar...
- Page 2 Short guide For full details, please read and take note of the instructions for use. SSEMBLE * TouchSpray made under licence from The Technology Partnership plc.
- Page 3 Short guide For full details, please read and take note of the instructions for use. NHALE Sit in an upright position. Hold nebuliser handset horizontally.
- Page 4 Short guide For full details, please read and take note of the instructions for use. EBULISER HANDSET HYGIENE AT HOME Clean immediately after inhalation Warm water, washing up liquid Disinfect Disinfect in the steam disinfector for 6 minutes, or boil thoroughly in distilled water for 5 minutes.
- Page 5 Instructions for use ......3 .....33 Návod k použití ......65 ......95 Kasutusjuhend......127 Upute za uporabu ......157 Használati utasítás ......187 Notkunarleiðbeiningar....217 Instrukcja obs ugi ......247 Návod na použitie ......279 Navodila za uporabo....309 Kullan m talimatlar ......339 ® eFlow rapid - 2022-07...
- Page 6 ® eFlow rapid - 2022-07...
- Page 7 INSTRUCTIONS FOR USE ® For eFlow rapid Type 178G1005 Table of contents 1 IMPORTANT INFORMATION ............5 Organisation of warnings ..................5 Handling the nebuliser system................5 Treatment of babies, children and individuals requiring assistance ....6 2 PRODUCT DESCRIPTION..............7 Intended purpose....................8 Indication........................8 Intended use......................8 Contraindications ....................8 Intended patient group ..................9 Lifetime of the medical device................9...
- Page 8 Controller, connection cord and power adapter ..........21 Cleaning ........................ 21 Disinfection......................21 Storage......................... 21 6 TROUBLESHOOTING ..............22 7 DISPOSAL ..................26 8 SPARE PARTS AND ACCESSORIES .........26 9 TECHNICAL DATA ...............27 General......................... 27 ® eFlow rapid nebuliser handset ................. 27 Classification according to EN 60601-1 ............
- Page 9 IMPORTANT INFORMATION Handling the nebuliser Read these instructions for use and the instructions for use of the accompanying system accessories completely before using for Check the nebuliser system before each the first time. Keep them safe so that you use. can refer to them again later.
- Page 10 Treatment of babies, children and individuals requiring assistance WARNING: Children and anyone who requires assis- tance must be supervised constantly by an adult during inhalation therapy. This is the only way to ensure safe and effective treatment. These individuals often under- estimate the hazards associated with the equipment (e.g., risk of strangulation with the cable), and this can result in risk of...
- Page 11 PRODUCT DESCRIPTION ® Connection cord (connection between eBase Controller the controller and the nebuliser ON/OFF button handset) ® Two eFlow rapid nebuliser handsets Power adapter (incl. aerosol head) Country-specific adapter Medication cap (AU, EU, UK, US) Aerosol head - Carrying case and nebuliser handset ®...
- Page 12 (intense coughing). The nebuliser system must only be used in accordance with its intended purpose. Only original PARI accessories must be The frequency of inhalation sessions may used to operate the system (see “SPARE vary depending on the nebuliser solution PARTS AND ACCESSORIES”, page 26).
- Page 13 For babies and toddlers who head has a possible lifetime of between cannot use the mouthpiece to inhale, three and six months. If the nebuliser PARI offers appropriate masks as handset is used frequently (two or more accessories. different nebuliser solutions several times...
- Page 14 PREPARING FOR INHALATION Information for the first • Insert the batteries as indicated by the polarity symbols. application - Wash your hands thoroughly every time before using the nebuliser system. - To avoid irritation of the airways due to inhaling aerosol when it is too cold and impairment of the aerosol properties, do not use medications straight from the refrigerator.
- Page 15 Preparing the nebuliser • Replace the country-specific adapters for the power adapter as required. To handset unlock, press the clip and push the country-specific adapter upwards. CAUTION: When plugging in, make sure that the Check the parts of your nebuliser handset adapter (9a) engages in the power before each use.
- Page 16 • Insert the inspiratory valve (5) in the • Attach the mouthpiece (7) to the aerosol aerosol chamber. chamber. When doing so, check that the two valve flaps are seated correctly. They must lie perfectly flush and face towards the aerosol chamber following insertion.
- Page 17 • Connect the connection cord (8) to the • Close the medication reservoir. controller. • Check that all parts are connected tightly and that the medication reservoir • Place the nebuliser handset on a firm, is sealed. flat surface. • Add the quantity of medication prescribed by your doctor to the medication reservoir.
- Page 18 PERFORMING INHALATION • Sit in an upright position and relax. This A green LED next to the ON/OFF button makes inhalation easier and improves lights up and an audible signal (1 beep) is uptake of the medication in the airways. emitted to indicate readiness for use.
- Page 19 Screens during inhalation End of the inhalation session The following screens appear during the The inhalation session is finished as soon inhalation session: as no more aerosol is generated, and the following screen appears: Start During inhalation The controller switches off automatically. If the controller switches itself off consider- ably sooner or later than usual, follow the instructions in Chapter “TROUBLE-...
- Page 20 For safe disposal of the leftover medica- tion, follow the information in the medication package leaflet. Info: The nebulisation times may gradually become longer with increasing length of use. This does not constitute a malfunction of the nebuliser handset. • When operating with the power adapter: When the inhalation session has ended, disconnect the power adapter plug from the socket.
- Page 21 CLEANING AND DISINFECTION Nebuliser handset • Remove the inspiratory valve from the aerosol chamber. WARNING: • Remove the aerosol head (4). To do this, gently press the engaging The nebuliser handset (and the aerosol side hooks on the aerosol head head) must be cleaned immediately after together.
- Page 22 Hygienic reprocessing at CAUTION: home Do not use a brushes or any other tools to clean the aerosol head as they may cause damage to the product components. WARNING: Clean the nebuliser handset (incl. aerosol head) immediately after each application. NOTE: Rinsing all the parts of the nebuliser hand- set and the aerosol head in warm tap...
- Page 23 WARNING: Disinfect the nebuliser handset parts and the aerosol head at least once a day, e.g., immediately after cleaning at the end of the day (a nebuliser handset cannot be disinfected effectively unless it has been cleaned first). NOTE: Do not use a microwave to disinfect the aerosol head.
- Page 24 • Place the individual parts on a dry, clean surface and allow them to air-dry • Place the nebuliser handset compo- completely. nents in the instrument dishwasher. • Select the 93 °C programme (treatment time: 10 minutes). The effectiveness of this procedure has been validated using a G7736 disinfector made by Miele and using neodisher MA (Chemische Fabrik Dr.
- Page 25 Controller, connection cord Storage and power adapter Between applications, particularly for prolonged breaks in treatment, keep the nebuliser handset in a dry, dust-free place Clean the controller, the connection cord (e.g., nebuliser handset bag). and the power adapter as necessary with Pack the controller, the connection cord a clean, lint-free, damp cloth.
- Page 26 TROUBLESHOOTING You can correct malfunctions that occur during daily operation yourself. The following tables will help you to locate and correct the causes of malfunction. Screen Possible cause Solution (flashes alternately) Connection - Verify that all parts between the are securely controller and the connected.
- Page 27 Fault/Condition Possible cause/Solution The controller cannot be switched on - To switch on, press the (no beep, no orange or green light ON/OFF button for approx. 2 seconds. signal). - Is power cord plug plugged into mains and the device (for mains operation)? Does the power adapter LED light up? - Are the batteries inserted correctly? - Check the charge level of the batteries.
- Page 28 Fault/Condition Possible cause/Solution The nebulisation times have become If the nebuliser handset is used regularly, considerably longer than normal. the nebulisation time will gradually become longer. This is not a malfunction. However, if you notice that the nebulisation time has become considerably longer (twice as long), this may be due to one of the following: - You are inhaling a different medication.
- Page 29 Fault/Condition Possible cause/Solution The medication cap cannot be The negative pressure in the medication removed from the medication reservoir is too high. reservoir after the inhalation • Open the aerosol chamber and gently treatment. pull the aerosol head so that air can flow The medication cap can now be removed easily.
- Page 30 Power adapter (100 to 240 V~, 50-60 Hz) 078B7114 Connection cord 178G6009 Carrying case 078E8005 PARI Filter valve set 041G0500 PARI SMARTMASK (adults) 041G0730 SMARTMASK Kids (children aged 2 and older) 078G5000 SMARTMASK Baby (babies weighing 2.5 kg and more)
- Page 31 TECHNICAL DATA General Technical electromagnetic compatibility data in table form is available upon request from PARI Pharma GmbH or on the Internet under the following link: https://www.pari.com/fileadmin/Electromagnetic-compatibility-4.pdf Electrical connection PARI power adapter REF 078B7114 Input: 100 to 240 V~, 50-60 Hz...
- Page 32 Classification according to EN 60601-1 Type of electric shock protection Protection class II (power adapter) Degree of protection from electric shock of Type BF applied part (nebuliser handset) Degree of protection against ingress of IP 21 water as per IEC 60529 (IP rating) Degree of protection when used in the pres- No protection ence of flammable mixtures of anaesthetics...
- Page 33 Ambient conditions for Ambient conditions for operation transport and storage - Ambient temperature: - Temperature: -25 °C to +70 °C +5 °C to +40 °C - Relative humidity of ambient air: - Relative humidity of ambient air: 0% to 93% (non-condensing) 15% to 93% (non-condensing) - Air pressure: 500 hPa to 1060 hPa - Air pressure: 700 hPa to 1060 hPa...
- Page 34 SYMBOLS Medical device Follow the instructions for use Single patient – multiple use Direct current Alternating current Lot number Item number Serial number Unique Device Identifier Protection class of the applied part: Type BF Protection class II appliance The device is protected against dripping water Minimum and maximum ambient temperature Minimum and maximum humidity Minimum and maximum air pressure...
- Page 35 Caution Manufacturer Date of manufacture ® eFlow rapid - 2022-07...
- Page 36 TERMS AND CONDITIONS OF WARRANTY PARI guarantees to you that if used for its - repairs, adaptations or modifications intended purpose your nebuliser system have been made to the device by will be free from defects in material or persons not authorised by PARI.
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