eFlow rapid nebuliser handset Instructions for Use April 2018

Kurzanleitung / Short guide Details bitte in der Gebrauchsanweisung nachlesen und beachten!

For full details, please read and take note of the instructions for use.

1 ZUSAMMENBAUEN 1 ASSEMBLE

*

*) TouchSpray® Technology made under licence from the Technology Partnership PLC.

Kurzanleitung / Short guide Details bitte in der Gebrauchsanweisung nachlesen und beachten!

For full details, please read and take note of the instructions for use.

2 INHALIEREN

2 INHALE

Aufrecht sitzen. Vernebler waagerecht halten.

Sit in an upright position. Hold nebuliser handset horizontally.

Kurzanleitung / Short guide Details bitte in der Gebrauchsanweisung nachlesen und beachten!

For full details, please read and take note of the instructions for use.

3 GERÄTE-HYGIENE 3 DEVICE HYGIENE ZU HAUSE AT HOME Sofort reinigen Warmes Wasser, Spülmittel

Clean immediately Warm water, washing up liquid

Desinfizieren 6 Minuten in Vaporisator desinfizieren oder 5 Minuten in destilliertem Wasser auskochen.

Disinfect Disinfect in the steam disinfector for 6 minutes, or boil thoroughly in distilled water for 5 minutes.

Trocknen An der Luft (ca. 4 Stunden) trocknen. An einem sauberen, trockenen Ort aufbewahren.

Dry Allow to air dry (for about 4 hours). Store in a clean, dry place.

de Gebrauchsanweisung ...3 en Instructions for use ...29 da Brugsanvisning...55 es Instrucciones de uso...79 fr Notice d'utilisation...105 it Istruzioni per l'uso ...131 nl Gebruiksaanwijzing ...157 no Bruksanvisning...183 pt Manual de instruções ...207 sv Bruksanvisning...233

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INSTRUCTIONS FOR USE

For eFlow®rapid Type 178G1005

Table of contents 1 IMPORTANT INFORMATION ...31 Organisation of warnings ...31 Handling the nebuliser system...31 Treatment of babies, children and individuals requiring assistance ...32

2 PRODUCT DESCRIPTION...33 Intended use...34 Proper use ...34 Intended patient groups ...34 Medications ...34 Life cycle ...34

3 PREPARING FOR INHALATION...35 Information for the first application ...35 Preparing the controller ...35 Operation with the supplied batteries or standard commercial rechargeable batteries ...35 Operation with the power adapter...35 Preparing the nebuliser handset ...36

4 PERFORMING INHALATION ...39 Pausing during inhalation...39 Display indicators during inhalation...40 End of the inhalation session ...40

5 CLEANING AND DISINFECTION ...41 Nebuliser handset...41 Preparation ...41 Cleaning...42 Disinfection ...42 Controller and connection cord ...44 Storage ...44

6 TROUBLESHOOTING ...45 7 DISPOSAL...49 8 SPARE PARTS AND ACCESSORIES ...49 eFlow®rapid - 04/18

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9 TECHNICAL DATA ...50 General... 50 Classification according to DIN EN 60601-1 ... 50 Materials used ... 51 Ambient conditions for operation ... 51 Storage and transportation conditions ... 51

10 EXPLANATION OF SYMBOLS ...52 11 TERMS AND CONDITIONS OF WARRANTY...53 Service and manufacturer ... 53

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IMPORTANT INFORMATION

Read these instructions for use and the instructions for use of the accompanying accessories completely before using for the first time. Keep them safely so that you can refer to them again later. If these instructions for use are not followed, injuries or damage to the product cannot be ruled out. You should have a medical examination before treating illnesses.

Organisation of warnings In these instructions for use, safetyrelated warnings are organised in hazard levels: - The signal word CAUTION is used to indicate dangers which may result in slight to moderate injuries or impair treatment if precautionary measures are not taken. - The signal word NOTE is used to indicate general precautionary measures for working with the product which should be followed to avoid damaging the product.

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Handling the nebuliser system Check the nebuliser system before every application. Replace all broken, misshapen and heavily discoloured parts. Damaged parts can impair the function of the nebuliser system and thus also affect treatment. Do not operate the nebuliser system if the power adapter is visibly damaged, since otherwise there is a danger from contact with live parts (e.g., electric shock). In this case, follow the instructions below: - Always remove the power adapter from the socket to ensure that the power is completely cut off. - Never remove the power adapter from the socket with wet hands. There may be a danger of electric shock. - Do not allow pets (e.g., rodents) near the cables. - Do not use the nebuliser system in areas where there is a risk of explosion or in the presence of gases that promote combustion (e.g., oxygen, nitrous oxide, flammable anaesthetics). - Do not carry out an inhalation session while you are driving a motor vehicle (risk of accident).

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Treatment of babies, children and individuals requiring assistance - Babies, children and anyone who requires assistance must be supervised constantly by an adult during inhalation therapy. This is the only way to ensure safe and effective treatment. These individuals often underestimate the hazards associated with the equipment (e.g. risk of strangulation with the cable), and this can result in risk of injury. - The product contains small parts. Small parts can block the airways and pose a choking hazard. Therefore, be sure to keep them out of the reach of children at all times. - The nebuliser handsets are only suitable for use by patients who can breathe unassisted and are conscious. This is the only way to ensure effective treatment and avoid a choking hazard.

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PRODUCT DESCRIPTION 4 4a

4b

5 3*

1 6 9

7a 7

9a 5a 2

8 1 Controller 2 2 complete nebuliser handsets (incl. aerosol heads): 3 Aerosol head* 4 Medication cap (preassembled), consisting of: 4a Cap seal 4b Cap 5 Medication reservoir and 5a Aerosol chamber (preassembled) 6 Inspiratory valve 7 Mouthpiece with 7a Expiratory valve (preassembled)

8 Connection cord (connection between the controller and the nebuliser handset) 9 Power adapter 9a Interchangeable adapter (3 items) - Transport case and nebuliser handset bag - easycare cleaning aid for aerosol heads Check that all components are contained in your package. If they are not, contact your local service partner (see "Service and manufacturer" on page 53).

*) TouchSpray® Technology made under licence from the Technology Partnership PLC

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Intended use

Intended patient groups

The eFlow®rapid inhalation system is

The nebuliser system is only suitable for use by patients who can breathe unassisted and are conscious. Inhalation with the mouthpiece is the most effective form of inhalation, since it results in minimum medication loss on the way to the lung. For babies and infants who cannot use the mouthpiece to inhale, PARI offers appropriate masks as accessories.

intended for the treatment of diseases of the airways and lungs.

Proper use The nebuliser system must only be operated in accordance with its intended purpose. The frequency of application may vary depending on the clinical picture and the medication used. The nebuliser handset is designed for use by one patient only. Info: The eBase Controller can also be used for a medication-specific nebuliser handset. Follow the instructions for use of the nebuliser handset as well. CAUTION: Medications that are approved for inhalation with a medication-specific nebuliser handset must not be used with an eFlow®rapid nebuliser handset (risk of incorrect dosage). Only original PARI accessories must be used to operate the system. CAUTION: Using accessories (components or cables) other than those supplied as spare parts by the manufacturer may cause increased electromagnetic emissions or reduced electromagnetic immunity, leading to a malfunction. PARI Pharma GmbH is not responsible for damage if the system is used improperly or contrary to the instructions.

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Medications The eFlow®rapid inhalation system must only be used to nebulise permitted inhalation solutions and suspensions. These are usually specified by the doctor. Take note of any limitations in the package leaflet accompanying each medication. CAUTION: Never attempt to inhale essential oils, as this can cause irritation of the airways (intense coughing).

Life cycle - Controller: 3 to 5 years - Nebuliser handset (without aerosol head): 1 year - Aerosol head: 3 to 6 months The expected life cycle of the aerosol head depends on how often and for how long it is used. With two inhalation treatments lasting a total of 30 minutes’ inhalation time and one disinfection per day, a life cycle of up to 6 months can be expected.

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PREPARING FOR INHALATION

Information for the first application - To avoid irritation due to inhaling aerosol when it is too cold, do not use medications straight from the refrigerator. - Clean the nebuliser handset and aerosol head before the first application (see CLEANING AND DISINFECTION, page 41). - The controller can be operated with non-rechargeable batteries or rechargeable batteries, or it can be connected to the mains power supply via the power adapter supplied.

Preparing the controller Operation with the supplied batteries or standard commercial rechargeable batteries Info: Rechargeable batteries cannot be recharged in the controller! • Open the battery compartment by lifting the clip:

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• Insert the batteries as indicated by the polarity symbols:

• Close the battery compartment. Operation with the power adapter Check that the power adapter is intact before every application. Do not use a power adapter that is damaged or faulty. Info: The batteries or rechargeable batteries can be left in the controller while the device is operated on mains power with the power adapter. This does not deplete the energy reserves of the batteries or rechargeable batteries.

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• Replace the country-specific adapters for the power adapter as required. To unlock, press the clip and push the interchangeable adapter upwards. When plugging in, make sure that the adapter (9a) engages in the power adapter housing.

9a

Preparing the nebuliser handset CAUTION: Check the parts of your nebuliser handset before every application. Replace all broken, misshapen and heavily discoloured parts. Damaged parts and incorrectly assembled nebuliser handsets can impair the function of the nebuliser handset and thus also affect the treatment. Info: The medication reservoir and the aerosol chamber are already preassembled. • Open the aerosol chamber (5a):

• Connect the power adapter to the power cord socket on the controller:

5a

When the power adapter is plugged into a socket, the controller is ready for use.

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en • Insert the aerosol head (3). It must snap noticeably into place.

• Close the aerosol chamber:

NOTE: Do not touch the membrane (metal part in the middle of the aerosol head), it can be damaged very easily.

NOTE: If the button closure does not close, ensure that the inspiratory valve is seated correctly. It must lie flat against the aerosol chamber. 3 • Attach the mouthpiece (7) to the aerosol chamber. • Insert the inspiratory valve (6). When doing so, check that the two valve flaps are seated correctly. They must lie perfectly flush.

7

6

Info: For inhalation with a mask, follow the instructions for use of the mask you are using.

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• Connect the connection cord (8) to the controller and the nebuliser handset.

• Close the medication reservoir:

8

• Check that all parts are connected tightly and that the medication reservoir is sealed:

• Add the quantity of medication prescribed by your doctor to the medication reservoir: CAUTION: Ensure that the medication is filled no higher than the upper scale graduation mark (6 ml). Do not overfill under any circumstances!

Info: If you intend to inhale several medications one after the other, rinse all nebuliser handset parts thoroughly with warm tap water before refilling.

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PERFORMING INHALATION

• Sit in an upright position and relax. This makes inhaling easier and improves uptake of the medication in the airways. • Hold the nebuliser handset in your hand. CAUTION: Hold the nebuliser handset horizontally throughout the inhalation session. If held in a tilted position, an incorrect dosage may occur. • Hold the mouthpiece between your teeth and enclose it with your lips without blocking the blue expiratory valve.

A green LED lights up and an audible signal (1 beep) is emitted to indicate proper functioning. • Inhale and exhale slowly and deeply through the mouthpiece. The mouthpiece can also remain in the mouth while exhaling. Do not breathe through your nose. You may use a nose clip if your doctor agrees. Info: It is normal for aerosol to escape through the expiratory valve in the mouthpiece during exhalation; this is not a malfunction.

Pausing during inhalation If it is necessary to interrupt the inhalation session briefly, use the Pause function: • Press the ON/OFF button for approx. 1 second. Pause mode is activated if the LED flashes green. • Press the ON/OFF button for approx. 1 second again to resume the inhalation session. • Press the ON/OFF button on the controller to start the inhalation session:

Info: The Pause function is available for use after an operating time of at least 5 seconds. If pausing for a longer time, switch the controller off by pressing the ON/OFF button for approx. 2 seconds. As long as there is enough liquid in the medication reservoir, the nebuliser handset can be restarted by pressing the ON/OFF button again.

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Display indicators during inhalation The following indicators appear on the display during inhalation:

End of the inhalation session The inhalation session is finished as soon as no more aerosol is generated and the following message appears in the display:

Start

The controller switches off automatically.

During inhalation

Nebulising with battery power

Nebulising with mains power

Activated Pause function

Pause function when operating with batteries

Info: The nebulising time may become longer with increasing length of use. This does not constitute a malfunction of the nebuliser handset. Info: Note that about 1 ml of medication cannot be nebulised and remains unused in the medication reservoir; this residue must be discarded. This is necessary to ensure a safe quantity of medication is delivered and does not constitute a malfunction:

approx. 1 ml • When operating with the power adapter: When the inhalation session has ended, disconnect the power adapter plug from the socket.

Pause function with mains power

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CLEANING AND DISINFECTION

Nebuliser handset The nebuliser handset (and the aerosol head) must be cleaned immediately after each use, and disinfected once a day. Preparation Disassemble the nebuliser system into its constituent parts: • Pull the connection cord out of the nebuliser handset: • Remove the mouthpiece from the nebuliser handset. • Carefully pull the blue expiratory valve (7a) on the mouthpiece (7) out of the slot. Info: The expiratory valve is held in place by a thin fixing clip so that it cannot get lost. This clip must not be detached from the mouthpiece.

• Disassemble the medication cap. To do this, press the cap seal (4a) downwards and out of the cap (4b).

4b 4a

• Open the aerosol chamber. • Remove the aerosol head. To do this, gently press the engaging hooks on the aerosol head together from the side:

7

7a • Open the medication reservoir and pour out the medication residue.

• Remove the inspiratory valve from the aerosol chamber.

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