PARI LAMIRA (01) PDF Document

To operate the PARI LAMIRA nebuliser system safely, follow these instructions:

• Check the nebuliser system before each use. Replace any broken, deformed, or heavily discoloured parts.

• Do not use the nebuliser system if the power adapter shows visible signs of damage to avoid the hazard of live parts (electric shock).

• Always unplug the power adapter from the socket to ensure complete disconnection from the mains.

• Never disconnect the power adapter from the socket with wet hands to avoid an electric shock.

• Do not allow pets (e.g., rodents) to get close to 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, nitrogen oxide, flammable anaesthetics).

• Keep the nebuliser system away from hot surfaces (e.g., a hob).

• Do not use the system while operating motorised vehicles due to the risk of an accident.

People who need assistance must be supervised constantly by an adult during the nebuliser treatment. This is the only way to ensure safe and effective treatment. Such persons often underestimate the hazards associated with the devices (e.g., risk of strangulation with the cable), which can lead to injuries.

Additionally, the product contains small parts which can block the airways and pose a choking hazard. Therefore, make sure that they are always kept out of the reach of children.

Before the first use of your PARI LAMIRA, please follow these steps:

1. Wash your hands thoroughly every time before using the nebuliser system.

2. To ensure the nebuliser handset functions properly, ARIKAYCE must be brought to room temperature. Therefore, take ARIKAYCE out of the refrigerator 45 minutes before its application.

3. In order to prepare and use ARIKAYCE, follow the instructions in the package leaflet for the medication.

4. Clean and disinfect the nebuliser handset and aerosol head before using them for the first time.

The controller can be operated with the delivered batteries or with commercially available rechargeable batteries. Note that rechargeable batteries cannot be charged in the controller.

1. Open the battery compartment by lifting the clip.

2. Insert the (rechargeable) batteries into the compartment so that they match the symbols +/-.

3. Close the battery compartment.

Mains power:

Make sure that the power adapter is undamaged before every use. If the power adapter is damaged or faulty, do not use it.

The eBase® Controller was developed for mobile use. Therefore, insert (rechargeable) batteries before use and leave them in the controller during mains operation. This guarantees smooth functionality and does not deplete the energy reserves of the (rechargeable) batteries.

Before every use, check the nebuliser handset parts. Replace any broken, deformed, or heavily discoloured parts. Damaged or incorrectly assembled parts can impair the function and affect the treatment.

1. To replace the country-specific adapter for the power adapter as required, press on the clip and push the adapter upwards. When inserting the new adapter, make sure that it engages in the power adapter housing.

2. Connect the power adapter to the power cord socket on the controller.

3. Plug the power adapter into an electrical wall socket.

4. Insert the aerosol head into the openings on the medication reservoir (with the aerosol chamber opened). It must snap noticeably into place. Do not touch the membrane (the curved metal surface in the middle of the aerosol head) to avoid damage.

5. Insert the inspiratory valve into the aerosol chamber. Ensure that both valve flaps are seated correctly and face the aerosol chamber after insertion. They must lie perfectly flush.

6. Close the aerosol chamber. If the snap closure does not close, check whether the inspiratory valve has been inserted correctly. It must lie flush against the aerosol chamber.

7. Attach the connection cord to the nebuliser handset.

8. Attach the connection cord to the controller.

9. Fasten the mouthpiece to the aerosol chamber.

10. Add the contents of a vial of ARIKAYCE to the medication reservoir.

11. Close the medication reservoir.

12. Check that all parts are connected tightly and that the medication reservoir is sealed.

1. Sit in an upright position and relax. This makes inhaling easier and improves uptake of the medication in the airways.

2. Hold the nebuliser handset horizontally in your hand at all times while performing inhalation. If the handset is tilted, it may result in an incorrect dosage being delivered.

3. Press the ON/OFF button on the controller to start nebulisation. A green LED will light up, and an audible signal (1 beep) will indicate it’s ready for operation.

4. Hold the mouthpiece between your teeth and enclose it with your lips. The lips must not touch the blue expiratory valve.

5. Breathe in and out slowly and deeply through the mouthpiece. The mouthpiece should remain in your mouth while you are breathing out as well. Do not breathe through your nose; use a nose clip if necessary.

The inhalation session should last approximately 14 minutes but can take up to 20 minutes. It is normal for some fluid to collect in the aerosol chamber and for some aerosol to escape through the expiratory valve on the mouthpiece while you exhale; this is not a malfunction.

The inhalation session can be interrupted briefly if necessary by using Pause mode. Pause mode can only be activated after a few seconds of operation.

• Press the ON/OFF button for approx. 1 second. Pause mode is activated when the LED light flashes green.

• Press the ON/OFF button for approx. 1 second again to resume the inhalation session.

For longer pauses, switch the controller off by pressing the ON/OFF button for at least 2 seconds. Provided there is enough liquid in the medication reservoir, nebulisation can be restarted by pressing the ON/OFF button.

The following indicators appear on the display during inhalation:

• Start: The eFlow TECHNOLOGY logo is displayed.

• During inhalation (battery power): An icon of the nebuliser emitting aerosol with a battery symbol is shown.

• During inhalation (mains power): An icon of the nebuliser emitting aerosol with a plug symbol is shown.

• Pause mode activated (battery power): An icon of the nebuliser, a battery symbol, and a pause symbol (II) are shown.

• Pause mode activated (mains power): An icon of the nebuliser, a plug symbol, and a pause symbol (II) are shown.

Inhalation is ended as soon as no more aerosol is generated. An audible signal (2 beeps) is emitted, and a check mark appears in the display of the controller. The controller will then switch itself off automatically.

Always check to make sure that the entire dose of ARIKAYCE has been nebulised:

1. Open the medication cap and check the contents of the medication reservoir.

2. If more than a few drops of ARIKAYCE are still in the medication reservoir, continue the inhalation session by putting the medication cap back in its place and then pressing the ON/OFF button.

When the system is used regularly, the time needed to complete nebulisation may slowly increase. This is not a malfunction.

After the session has ended, immediately carry out the hygiene procedures. If using the power adapter, disconnect it from the socket.

To prepare the PARI LAMIRA for cleaning, dismantle the nebuliser handset into its individual parts:

1. Pull the connection cord out of the nebuliser handset.

2. Remove the mouthpiece from the nebuliser handset.

3. Open the medication reservoir. The medication reservoir and aerosol chamber are preassembled and must not be detached from one another.

4. Open the aerosol chamber.

5. Remove the inspiratory valve from the aerosol chamber.

6. Remove the aerosol head by gently pressing the lateral engaging hooks together. Be careful not to touch the membrane (the curved metal surface in the middle of the aerosol head) to avoid damage.

The nebuliser handset and the aerosol head must be cleaned immediately after each application. Placing the parts in warm washing water straight after use prevents medication residue from accumulating.

1. Rinse all nebuliser handset parts and the front and back of the aerosol head (for 10 seconds each) under warm running tap water (drinking water quality, temperature up to 37 °C).

2. Place all nebuliser handset parts and the aerosol head in warm tap water with a little washing up liquid for 5 minutes. If the parts are heavily soiled, move the nebuliser handset parts gently back and forth in the washing water. Do not use any brushes or other tools to clean the aerosol head.

3. Rinse all parts thoroughly under warm running tap water to remove the dishwashing soap. Check each part, and if soiling is still visible, place the part in washing water for another 5 minutes.

4. Shake all parts to remove most of the water before disinfection.

Disinfect the nebuliser handset and aerosol head immediately after cleaning them. Do not use a microwave to disinfect the aerosol head.

Boiling in distilled water:

1. Place all parts in boiling water for at least 5 minutes. Use a clean pot and distilled water. Ensure there is enough water in the pot to prevent the plastic parts from melting on the hot bottom.

2. Take the parts out of the pot.

3. Shake all parts to remove most of the water.

4. Place the individual parts on a dry, clean surface and allow them to dry completely. Ensure adequate drying as moisture promotes the growth of bacteria.

5. Check the individual parts after every disinfection and replace any broken, deformed, or heavily discoloured parts.

Alternative: Using a thermal disinfector for baby bottles:

• To ensure effective disinfection, use a thermal disinfector with an operating time of at least 6 minutes. Follow the instructions for use of the thermal disinfector.

• Inadequate disinfection promotes the growth of bacteria. Do not switch the device off before the disinfection cycle is complete. Ensure the thermal disinfector is clean and functions properly.

• Take the parts out immediately after disinfection is complete. Place them on a clean, dry surface and allow them to dry.

Cleaning:

Clean the housing surface of the controller and the cable as necessary with a clean, damp cloth. Do not hold the controller under running water or use liquid cleaning agents.

Disinfection:

Disinfect the controller, connection cord, and power adapter immediately after cleaning. Use an alcohol-based, standard commercial disinfectant wipe. Follow the instructions for use of the disinfectant wipe. Allow the components to dry completely.

Between applications, particularly during longer breaks in treatment, keep the nebuliser handset in a dry, dust-free place. Pack the controller, power adapter, and connection cord in the case provided for this purpose.

Note: Leaking batteries can damage the controller. Therefore, take the (rechargeable) batteries out of the controller if you do not intend to use the nebuliser system for a longer period.

If the screen alternately flashes an icon showing the controller and an icon showing the nebuliser with a disconnected cable between them, it means the cable connection to the controller or on the nebuliser handset is interrupted. You should check the cable connections.

If the screen alternately flashes an icon of the medication reservoir with an empty indicator and a full indicator, it means no medication has been added. You should fill the reservoir with medication.

If the screen alternately flashes an icon of the controller and an “ON” icon with the nebuliser, it means the inhalation was interrupted. To continue, resume inhalation by restarting the device (press the ON/OFF button).

A flashing warning triangle on the screen indicates that the maximum operating time of 20 minutes per inhalation session has been exceeded. To continue, resume inhalation by restarting the device (press the ON/OFF button).

If the battery icon is flashing and shows a charge level less than 50%, you should have new (rechargeable) batteries ready. If the battery icon is flashing and appears flat/empty, you need to insert new batteries or connect the power adapter.

If the controller cannot be activated (no beep, no orange or green light signal), try the following solutions:

• To switch the device on, press and hold the ON/OFF button for approx. 2 seconds.

• Is the power plug connected to the power supply and the device?

• Are the (rechargeable) batteries inserted correctly?

• Check the charge level of the (rechargeable) batteries.

If, after switching the controller on, no aerosol is generated, and/or the controller switches itself off again after a few seconds, check the following:

• Has the medication reservoir been filled?

• Check the connection between the controller and the nebuliser handset.

If the controller switches itself off even though there is still medication in the medication reservoir, consider these possible causes and solutions:

• Check the charge level of the (rechargeable) batteries.

• The nebuliser handset was not being held horizontally. Hold the nebuliser handset horizontally.

• The controller switches itself off automatically after 20 minutes. Press the ON/OFF button again to continue the inhalation session and inhale the prescribed dosing of medication.

When the system is used regularly, the time needed to complete nebulisation may slowly increase. This is not a malfunction. However, if you notice that the nebulisation times have become significantly longer, it may be due to one of the following reasons:

• The medication cap was not closed correctly.

• The aerosol head was not cleaned immediately after the last application, or it is damaged.

• You are using the aerosol head for longer or more often than is recommended in the “Lifetime of the medical device” section.

If aerosol escapes continuously in large volumes from the opening slots in the medication reservoir, check whether the nebuliser handset has been assembled correctly. When doing so, ensure that both valve flaps of the inspiratory valve are seated correctly. When the valve is inserted, they must lie flat and face towards the aerosol chamber.

A small amount of fluid collects in the aerosol chamber during inhalation. When the nebuliser handset is tilted, it can escape through the mouthpiece. To prevent this, hold the nebuliser handset horizontally during use.

Some drops of fluid can collect on the expiratory valve on the mouthpiece during treatment and may run down the mouthpiece. To manage this, keep a cloth to hand.

The negative pressure in the medication reservoir is too great. To resolve this, open the aerosol chamber and carefully pull the aerosol head to enable air to flow in. The medication cap can now be removed easily.