• Introduction
  • What Is the Lamira™ Nebulizer System?
  • The Lamira™ Nebulizer System Components
  • Getting Started
  • Operating the Lamira™ Nebulizer System
  • Troubleshooting Potential Problems
  • Progress Check Questions
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INTRODUCTION

Welcome to the Lamira™ Nebulizer System and Instructions for Use educational magazine, which will give you an in-depth look at the Lamira Nebulizer System (Lamira) that patients will use each day to take ARIKAYCE® (amikacin liposome inhalation suspension). After reviewing the contents of this eMagazine, you should be able to:

  • Discuss with HCPs and office staff the Lamira Nebulizer System to administer ARIKAYCE® for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) as part of a combination antibiotic regimen for adult patients;
  • Describe how to operate, maintain, and troubleshoot problems with the Lamira Nebulizer System; and
  • Understand the importance of physician and patient comfort with knowing how to use Lamira.

Instructions on eMagazine Icons

Throughout this eMagazine, you will encounter icons which when selected, offer more information around the topic being discussed.

Note that you may download and take notes on a PDF version of this installment of inspireWIRE by selecting the Resources download icon.

At the end of this eMagazine, you will be required to take the progress check and you should select the “Get Course Credit” button when you are done to receive credit.


WHAT IS THE LAMIRA™ NEBULIZER SYSTEM?

A Brief Overview

The Lamira Nebulizer System is an electronic nebulizer that uses eFlow® technology designed to enable aerosolization of ARIKAYCE® via a vibrating, perforated membrane that includes thousands of laser-drilled holes.

Patients are prescribed ARIKAYCE® for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) as part of a combination antibiotic regimen for adult patients. This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Durability of sputum culture conversion at 3-months after cessation of therapy has not yet been established.

Lamira includes multiple components that need to be cleaned and disinfected prior to their first use and following each use. When Lamira is maintained and used properly, treatment with ARIKAYCE® should take patients approximately 14 minutes. However, treatment time can vary and could take up to 20 minutes. To make it easier to travel with, Lamira is designed to be lightweight and portable.

Lamira was optimized specifically for use with ARIKAYCE®. Why is this important?

Select the icon to learn more.

Lamira uses eFlow technology, designed to produce aerosols with a high density of active drug and a precisely defined droplet size. Advances in technology allowed the device manufacturer, PARI, to tailor the design of its eFlow nebulizers. The technology allows for versatility with respect to target droplet size, drug volume, and dosage. This means that the device is customized for a specific clinical application.

In addition, because particle size distribution is an important factor in how much medication reaches the site of infection in the lung, laser-drilled holes in the Lamira aerosol head were designed to have a very narrow size distribution—designed specifically for ARIKAYCE® delivery into the deep lung.



THE LAMIRA™ NEBULIZER SYSTEM COMPONENTS

What Is Included in the Lamira Nebulizer System Package and ARIKAYCE® 28-Day Drug Kit?

It is important for you to understand how to use Lamira to help address any questions or concerns the prescribing physician may have about the use of the device. This eMagazine includes step-by-step instructions on how to assemble, operate, and maintain Lamira. Throughout this eMagazine, you will see select Warnings and other important information related to the topic being presented. The Instructions for Use contains additional information that can help patients use their Lamira as intended. Patients should be advised to read and understand the entire Instructions for Use, including all safety precautions, prior to using their Lamira. Patients may also contact ARIKARES at 1-833-274-5273 with any questions.

Select the icon for more information on how to use Lamira safely.

Before learning about operating Lamira, you should become familiar with the various Lamira components as well as what the patient receives in each 28-Day Drug Kit.

Select the icons to see what’s inside the Lamira Nebulizer System and each ARIKAYCE® 28-Day Drug Kit.

To reduce the risk of fatal injury from electrocution:

  • Patients should not place or store the Lamira Nebulizer System near water or other liquid such as a bathtub or sink, place or drop the Lamira Nebulizer System into water or other liquid, or use while bathing.
  • Patients should not reach for the Lamira Nebulizer System if it has fallen into water or other liquid; the System should be unplugged right away and picked up only after it has been unplugged.

Before using Lamira, patients should be aware of the following important points:

  • Patients should not share their Handset with other people.
  • Patients must never use other medications in the Handset. Using other medicine in the Lamira nebulizer can result in severe injury or death.

Please be aware that these are not all the warnings. Please refer to the full IFU.

Lamira Nebulizer System

  • A. Carrying Case
  • B. A/C Power Supply
  • C. “AA” Batteries
  • D. Connection Cord
  • E. Controller
  • F. Spare Aerosol Head
  • G. Spare Handset

The Aerosol Head and Handset (including the Medication Cap, and Mouthpiece) should be set aside as spare. Patients will receive a new Handset and 4 Aerosol Heads with their 28-Day Drug Kit.

ARIKAYCE® 28-Day Drug Kit

Each 28-Day Drug Kit contains:

  • A. ARIKAYCE® Quick Start Guide
  • B. Instructions for Use
  • C. Full Prescribing Information
  • D. Handset (including Aerosol Chamber, Medication Cap, Blue Valve, and Mouthpiece)
  • E. 4 Aerosol Heads (each one is to be used for 7 days and replaced)
  • F. 28 vials of ARIKAYCE® (4 boxes with 7 vials each; 1 vial is to be used each day for 28 days)

It is important for patients to use a new Aerosol Head at the start of each week and to clean and disinfect it before they use it for the first time.


GETTING STARTED

Choosing the Power Supply

Lamira can be used with 4 “AA” batteries or the A/C Power Supply.

Use the arrows to review the instructions patients will need to follow when choosing a power option.

First slide
Second slide

Four high-quality “AA” batteries should provide 2 hours of total use. Note that rechargeable and disposable batteries have differences in storage life and output. If storing the Controller for more than 30 days, remove the batteries to reduce the risk of battery leakage.

Step 1: Open the Battery Door on the Controller by placing your thumb on the tab of the Battery Door and firmly pulling the tab to open the Door.

Step 2: Load the Batteries. Each Battery Chamber has a small figure showing the proper position of each battery.

Step 3: Close the Battery Door. You should hear a “click” when the door is closed properly.

If patients choose not to use the A/C Power Supply, they should be advised to carry an extra set of batteries with them at all times.

Second slide

The A/C Power Supply will automatically adjust to incoming voltage and will power the Controller with or without installed batteries. It can be used worldwide, but requires “Plug Converters” for use outside the USA.

Step 1: If necessary, insert the Plug Converter into the A/C Power Supply.

Step 2: The Controller should be placed on a clean, flat, stable surface. Plug the A/C Power Supply into the Controller by pushing the round end of the A/C Power Supply plug into the Plug Inlet Port, which is located on the underside of the gray Battery Door. Do not try to insert the A/C Power Supply into the front of the Controller.

Step 3: Plug the A/C Power Supply into the wall outlet.

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OPERATING THE LAMIRA NEBULIZER SYSTEM

Assembling the Handset

Note: The Handset and Aerosol Head must be cleaned and disinfected prior to first use and after each use. For more information, refer to the section, Disassembling, Cleaning and Disinfecting the Lamira Nebulizer System.

Before patients can take their medication each day, they will need to assemble the Handset. This section covers all of the steps involved in getting Lamira ready for use. If any parts are damaged, patients should call ARIKARES at 1-833-274-5273 to request replacement parts. It is important to note that the Handset and Aerosol Head are not sterile and must be cleaned and disinfected before using it for the first time and after each use. Patients should be instructed to inspect all parts to make sure they are cleaned and not visibly damaged.

Use the arrows to see each step patients will need to follow when assembling their Handset.


STEP 1

Clean and disinfect the Handset and Aerosol Head before first use and after each use. Use clear liquid soap made for washing dishes to clean the Handset.

Patients should always begin assembly using components that have been properly cleaned and disinfected. This topic is covered in a separate section of this Article, Disassembling, Cleaning and Disinfecting the Lamira Nebulizer System.

STEP 2

Wash and dry your hands.

It is important that you wash and dry your hands before handling Lamira components that have already been cleaned and disinfected.

STEP 3

Open the Handset

The Medication Reservoir and the Aerosol Chamber are attached using a “hinge.” First, gently pull up on the tab of the Medication Reservoir. This will release the Aerosol Chamber so that you may open it.

STEP 4

Insert the Blue Valve

Insert the Blue Valve on top of the Aerosol Chamber. Make sure the 2 valve flaps are positioned down. Do not push the Blue Valve inside the Aerosol Chamber. The Blue Valve should be placed on top of the Aerosol.

STEP 5

Insert the Aerosol Head

Check to make sure the Aerosol Head is labeled “For Amikacin Liposome Inhalation Suspension”. Carefully grasp the Aerosol Head by the 2 flexible plastic tabs on each side of the Aerosol Head. Turn the Aerosol Head so that “for Amikacin Liposome Inhalation Suspension” is facing toward you and is at the top of the Aerosol Head.

Squeeze the two flexible plastic tabs together while inserting the metal arms and flexible plastic tabs into the Medication Reservoir. You should feel the flexible plastic tabs “grab” as you insert it.

It is important that patients are instructed that they should not touch the silver part of the Aerosol Head at any time during assembly.

STEP 6

Close the Handset

Close the Handset by pushing the Aerosol Chamber together with the Medication Reservoir until you hear a “snap.” If you do not hear a snap, open the Handset and check that the Blue Valve is seated properly.

STEP 7

Attach the Mouthpiece to the Handset

Attach the Mouthpiece to the Handset. Make sure the Blue Flap is facing up and is pressed in the slot on the Mouthpiece. Push the Mouthpiece straight onto the Handset. Make sure the Mouthpiece stays attached to the Handset during treatment.

STEP 8

Attach the Connection Cord

Attach the Connection Cord by lining up the bottom of the Connector with the bottom of the Handset and pushing the Connection Cord upward against the rear underside of the Handset until you hear the parts “snap” together.

STEP 9

Connect the Connection Cord to the Controller

Push the round end of the Connection Cord into the Plug Inlet Port located under the digital display. Place the Controller with the attached Handset on a clean, flat surface.

Previous Next

To view a video segment on assembling the Lamira Nebulizer System Handset, select the icon.

VIDEO COMING SOON!


Getting Ready to Take ARIKAYCE®

You should be familiar with the various steps patients need to follow when administering ARIKAYCE®. It is also important for you to be aware of potential operational and safety issues patients may have so that you are prepared to speak to the prescribing physician about them.

Select the icon for more information on potential operational and safety issues patients may encounter.

Before they start treatment, patients should be aware of the following important points:

  • If patients use a bronchodilator, they should use the bronchodilator before taking ARIKAYCE®. They should refer to the bronchodilator leaflet for information.
  • Each vial of ARIKAYCE® is for single use only.
  • Patients must never take ARIKAYCE® with any other type of Handset or Aerosol Head.
  • Lamira must only be used for ARIKAYCE®.
  • Patients must not inject or drink the liquid in the vial.
  • ARIKAYCE® should never be used if the manufacturer’s expiration date has passed or if the 6-week “use by” date indicated by the pharmacy has passed, whichever of the 2 dates comes first.

Please be aware that these are not all the Warnings. Please refer to the full IFU.

Use the arrows to see step-by-step instructions patients will need to follow when taking ARIKAYCE®.



STEP 1

Shake the ARIKAYCE® vial well for at least 10 to 15 seconds, until the medication looks the same throughout and is well mixed.

For Lamira to operate properly, ARIKAYCE® should be at room temperature. Patients should not use ARIKAYCE® if it has been frozen. They should contact ARIKARES with any questions or concerns at 1-833-274-5273.

STEP 2

Lift the orange cap from the vial and throw away the orange cap.

STEP 3

Grip the metal ring on top of the vial. Pull it down gently until one side breaks away from the vial.

STEP 4

Pull the metal band from around the vial top in a circular motion until it comes off completely from the vial. Throw away the metal band after it is removed.

STEP 5

Carefully remove the rubber stopper by pulling it upward.

STEP 6

Make sure the Handset is placed on a clean, flat, stable surface. Pour only 1 vial of ARIKAYCE® into the Medication Reservoir.

Patients should never use more than 1 vial for each treatment.

STEP 7

Attach the Medication Cap by lining up the Tabs on the Medication Cap with the Tab Slots on the Medication Reservoir. Turn the Medication Cap clockwise until it stops. As the Medication Cap is turned, the inner cap of the Medication Cap should rise.

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Administering ARIKAYCE®

This section will help you understand the functionality of the Controller included with the Lamira Nebulizer System. Knowing how to operate Lamira will help you communicate with the prescribing physician about key points regarding operation of Lamira.

The Controller has an On/Off button, an LED status light, and an LCD display. The LCD display and status light, as well as a “beeping” sound, will help guide patients through their treatment. As you will see in an upcoming section in this eMagazine, Troubleshooting Potential Problems, they can also help patients solve problems when the device is not operating properly.

The Controller should be placed on a clean, flat, and stable surface. It is important for patients to sit in a relaxed, upright position and to hold the Handset level throughout the duration of the treatment.

Select each of the topics below to reveal operational instructions and the corresponding audio and visual cues patients will receive while using their Lamira.

Operating Lamira

To begin treatment, sit in a relaxed, upright position. Press and hold the On/Off button for 2 to 3 seconds until the start screen appears on the LCD screen.

(Start screen)


You will hear 1 "beep."

The status light will turn green. The Lamira is now On.

(Treatment)

After treatment begins, the treatment screen will replace the start screen and aerosol mist will begin to flow.

Inhalation Technique

Insert the Mouthpiece by placing it on top of your bottom lip and tongue. Close your lips around the Mouthpiece. Take slow, deep breaths, then breathe normally in and out through the Mouthpiece until your treatment is complete.

Correct Technique

Incorrect Technique


Hold the Handset level throughout your treatment. If the Handset is held at an angle over 45 degrees, the following will occur.


You will hear 2 “beeps.”
The status light will show 2 green lights.

The Controller will shut down after 30 seconds. If this occurs, hold the Handset level and press the On/Off button to restart your treatment.

Pausing Treatment

Lamira can be stopped at any time during operation by pressing/holding the On/Off button for 3 seconds.

The LCD screen will go from On to Pause.
You will hear a 5-beep alarm tone.

The status light will flash red-green.

Resuming Treatment

To resume treatment while in pause mode, press the On/Off button for 1 full second.

The Controller will run for up to 20 minutes. If treatment is not complete after 20 minutes, press the On/Off button to continue treatment. 

Completing Treatment

The amount of time to nebulize ARIKAYCE® should take 14 minutes but could take up to 20 minutes. It is also important to note that the time may vary from dose to dose and may become longer unless the cleaning and maintenance instructions are followed. Refer to the section, Disassembling, Cleaning and Disinfecting the Lamira Nebulizer System, for more information.

At the end of treatment, the following will occur:

Lamira will “beep” 2 times.
The status light will flash red 2 times.
The Dose Complete Checkmark will appear briefly on the screen.

The Controller will automatically shut off.

Check the Medication Reservoir by removing the Medication Cap to make sure the full dose was completed. If more than a few drops remain, replace the Medication Cap and press the On/Off button to complete your dose.

The Handset should be cleaned and disinfected after each use. Patients should be instructed to change their Aerosol Head after 7 uses and to clean and disinfect it before they use it for the first time.

Button_1 Button_2 Button_3 Button_4

To view a video segment on administering ARIKAYCE®, select the icon.

VIDEO COMING SOON!


Disassembling, Cleaning and Disinfecting the Lamira Nebulizer System

Properly maintaining Lamira is a critical part of administration of ARIKAYCE®. Patients will need to disassemble their Lamira and clean the Handset and Aerosol Head right after each use. If the Aerosol Head becomes clogged, it can increase the time it takes patients to complete their dose.

To reduce the risk of infection, illness, or injury from contamination, patients should be instructed to clean and dry all parts of the Handset after each use. Patients are to be instructed to disinfect the Handset and Aerosol Head immediately after each cleaning. Disinfecting the Handset and Aerosol Head is important because cleaning them only removes the medication and saliva. Contamination and moisture may cause the growth of bacteria, which increases the risk of infection or illness.

Select the icon for more information on disassembling, cleaning and disinfecting.

Use the arrows to see step-by-step instructions patients will need to follow when disassembling, cleaning and disinfecting their Lamira.

Disassembling, Cleaning and Disinfecting the Lamira Nebulizer System

Contamination and moisture may cause the growth of bacteria and the Aerosol Head can be affected by ARIKAYCE® left over in it. It is important for patients to rinse and clean their Handset right after every use. If the Handset looks dirty, patients should soak the parts in soapy water for longer than 5 minutes. It is important to note that:

  • The Handset and Aerosol Head should not be placed in the dishwasher.
  • The Handset and Aerosol Head should not be put in a microwave oven.
  • Brushes and abrasives should not be used to clean the Handset and Aerosol Head.

To prevent serious or fatal illness or injury caused by contamination, patients should disinfect their Handset at the end of every day.

Please be aware that these are not all the warnings. Please refer to the full IFU.

STEP 1

Disconnect the Handset from the Connection Cord.

STEP 2

Remove the Medication Cap by turning counter clockwise and pulling straight up.

STEP 3

Remove the Mouthpiece from the Aerosol Chamber by pulling straight off. The Blue Flap must still be attached to the Mouthpiece.

STEP 4

Gently pull up on the tab to open the Handset and remove the Blue Valve.

STEP 5

Press the 2 flexible plastic tabs on the side of the Aerosol Head toward each other and remove.

Patients should never touch the center silver part of the Aerosol Head. One Aerosol Head should be used for 7 days. Patients should use a new Aerosol Head each week when they open a new box containing 7 ARIKAYCE® vials.

STEP 6

Rinse each of the parts under warm running tap water for 10 seconds.

Thorough rinsing of both sides of the Aerosol Head helps to prevent clogging and makes sure the Aerosol Head works properly. Patients should never use a brush or any other object to clean the Aerosol Head.

STEP 7

Clean all Handset parts by adding a few drops of clear liquid dish soap and warm tap water to a clean tub or bowl. Cover the Handset parts in the warm soapy water and soak for 5 minutes, shaking them periodically.

Patients should never use white or antibacterial liquid dish soaps because these may contain additives harmful to the Aerosol Head.

STEP 8

Rinse all parts thoroughly under warm running tap water to remove the soap. Check each part and soak for another 5 minutes if any of the parts look dirty.

STEP 9

Note: In the IFU, Step 9 refers patients to a separate section for disinfecting instructions. For training purposes, the steps for disinfecting Lamira are covered here.

Disinfect the Handset and Aerosol Head after cleaning. To prevent serious or fatal illness or injury caused by contamination, disinfect the Handset and Aerosol Head at the end of every day by following these instructions:

  • Boil the Handset parts, including the Aerosol Head, in a clean pot of distilled water for a full 5 minutes; then
  • Air dry all of the parts on a lint-free towel.

Once fully dry, the parts can be wrapped in the lint-free towel and stored until next use. Patients can reassemble the parts just prior to taking their next treatment.


Step 10

To reduce the risk of electric shock, disconnect all connections before cleaning. Switch off the Controller. Remove the Connection Cord and A/C Power Supply cord from the Controller.

STEP 11

Clean the Controller Housing and Connection Cord with a soft, clean, damp cloth.

Patients should never place the Controller unit under water or allow liquid to get inside the Controller. The Controller should not come in contact with water or cleaning agents. If liquid does get into the Controller, patients should contact ARIKARES at 1-833-274-5273.

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For a summary of the recommended Cleaning and Disinfecting Schedule, select the icon.


Instruction When Parts cleaned Method How Long Comments
Rinse After each use
  • Aerosol Head
  • Medication Cap and Seal
  • Blue Valve
  • Medication Reservoir and Chamber Mouthpiece
 Warm running tap water. 10 seconds Rinse each side of the Aerosol Head for 10 seconds.
Clean After each use
  • Aerosol Head
  • Medication Cap and Seal
  • Blue Valve
  • Medication Reservoir and Chamber Mouthpiece
 Soak each piece in warm, soapy water.
While soaking, swish or shake each piece. 		5 minutes Use 3 to 5 drops of clear liquid dish soap in a bowl with enough warm water to cover all pieces. Soak longer if Handset has dried or if visibly dirty.
Rinse After cleaning
  • Aerosol Head
  • Medication Cap and Seal
  • Blue Valve
  • Medication Reservoir and Chamber Mouthpiece
 Warm running tap water. Until soap is removed. Check each part and soak for another 5 minutes if any part looks dirty.
Disinfect Every day
  • Aerosol Head
  • Medication Cap and Seal
  • Blue Valve
  • Medication Reservoir and Chamber Mouthpiece
 Boil in distilled water. 5 minutes Air dry in a dust-free environment.

TROUBLESHOOTING POTENTIAL PROBLEMS

This section highlights the Frequently Asked Questions (FAQs) included in the Lamira Nebulizer System Instructions for Use. Knowing the answers to FAQs will help you in your conversations with the prescribing physician. Sharing this information with the prescribing physician may also guide their patient education discussions, allowing patients the best possible chance of using their Lamira correctly.

Select each of the FAQs to reveal the answers.

FAQs
Answer: With normal operation and proper cleaning, the Handset should deliver 1 vial of ARIKAYCE® in about 14 minutes but could take up to 20 minutes. Lamira should automatically shut off shortly after treatment is complete or after 20 minutes. If Lamira turns off after 20 minutes, check the Medication Reservoir to make sure the full dose has been taken.
Answer: Only a drop of ARIKAYCE® should remain in the Medication Reservoir. If more than a drop remains, start the Controller and complete the dose. Then, clean the Aerosol Head. If after proper cleaning, more than a drop remains in the Medication Reservoir, contact ARIKARES at 1-833-274-5273.
Answer:

The answer depends on which power option is being used.

  • If using batteries, use the figures in each Battery Compartment to check that the batteries are inserted correctly. If the batteries are positioned properly, check to see if the light is blinking on the Controller signaling low battery power. If it is, replace the batteries or use the A/C Power Supply.
  • If using the A/C Power Supply, check the connection to be sure it is firmly connected to the Power Supply Port located underneath the Battery Compartment. Be sure that the A/C Power Supply is plugged into a working wall outlet.

If there still seems to be no power after following these steps, contact ARIKARES at
1-833-274-5273.

Answer:

A vacuum has formed in the Medication Reservoir. Remove the Connection Cord, open the Handset and carefully remove the Aerosol Head. The Medication Cap will then be easier to remove.

Answer:

If there is no mist coming out of the Handset, complete the following steps in order:

  • 1. Check that the Controller has power.
  • 2. Make sure the Connection Cord is correctly attached.
  • 3. Check to be sure that the Handset has been assembled properly.
  • 4. Check to be sure that the ARIKAYCE® is in the Medication Reservoir.

If the Controller or the Handset still do not function properly, contact ARIKARES.

Answer:

The 2 recommendations for liquid leaking from the Handset are as follows:

  • To prevent leaks, be sure (1) the Blue Valve is properly attached to the Aerosol Chamber, (2) the Aerosol Head is inserted correctly, (3) the Medication Cap is screwed on fully, and (4) the Medication Reservoir and Aerosol Chamber are closed properly and snapped together.
  • It is normal to have some liquid collect in the Aerosol Chamber. Try to hold the Handset so that liquid does not pour out of the Mouthpiece.
Answer:

There are 3 potential reasons for this problem.

  • 1. Low voltage. Replace the batteries or use the AC adapter. Press the On/Off button to continue treatment.
  • 2. The Handset was tilted above 45°. Hold the Handset level and press the On/Off button to continue treatment.
  • 3. ARIKAYCE® is cold. Allow the ARIKAYCE® to warm to room temperature and then press the On/Off button to continue treatment.
Answer:

If the Controller does not shut off after treatment has ended, try the following steps in order:

  • 1. The Controller may take up to 60 seconds to shut off after the dose is completed. Press the On/Off button to stop the Controller earlier.
  • 2. If the issue is not resolved, disconnect the A/C Power Supply from the Controller and remove the batteries. Then, reinsert the batteries following the instructions in the section, Choosing the Power Supply.

If this situation continues 3 or 4 times, contact ARIKARES at 1-833-274-5273.

Answer:

A new set of batteries should provide 2 hours of total use. Consider using rechargeable batteries.

Answer:

Contact ARIKARES at 1-833-274-5273.

It is important to let physicians know that patients can call ARIKARES at 1-833-ARIKARE or 1-833-274-5273 with any questions or concerns they may have.

Troubleshooting

Lamira is equipped both to signal patients when Lamira is working properly and to alert them of potential problems.

Select the icon to see a full list of faults and conditions as well as the possible causes and solutions.

Fault and Condition Possible Cause and Solution

Steady

 The Controller is running on A/C power.

Steady

 The Controller is running on battery power.

Flashing

 The battery is empty. Replace the batteries or switch to A/C power.

Flashing

 The battery is low. Replace the batteries or switch to A/C power.

Flashing

Lamira turns on, but LED flashes red-green and LCD display flashes this symbol

This error message can mean one of two things:

  • Bad or Missing Connection Cord
    Check the Connection Cord between Handset and Controller, or
  • Bad or Missing Aerosol Head
    Correct this, and restart the Controller.

Flashing

 No ARIKAYCE® is detected. Add ARIKAYCE®. If ARIKAYCE® has already been added, gently tap the Handset, hold the Handset level and restart the Controller.

Flashing

 Lamira has reached the 20-minute maximum time and will shut down. If ARIKAYCE® remains, restart the Controller. After treatment is complete, clean and disinfect the Aerosol Head.

Steady

 Lamira is misting and working properly.

Steady

 The Controller has paused. To resume, press the On/Off button.

Flashing

 Press the On/Off button to start treatment.

Brief

 Lamira is functioning properly. The Controller has started properly.

Brief

 There is no ARIKAYCE® remaining. Treatment is complete. If ARIKAYCE® is remaining, the Handset might be tilted. Keep the Handset level, gently tap the Handset, and restart the Controller.
Lamira cannot be activated and there is no green LED (status light), no screen, and no beep.

This error means one of two things:

  • Bad, missing, or misloaded batteries, or
  • Bad or missing A/C Power.
Lamira beeps 1 time and begins to produce a mist, then stops and shuts off with no beep, no LED (status light), and with ARIKAYCE® still present.

This error means one of two things:

  • Bad batteries, or
  • Bad A/C Power.

Replace the batteries or A/C Power Supply and restart the Controller.

Lamira stops before ARIKAYCE® is completely used up.

This error means one of two things:

  • Lost power. Replace batteries or use A/C Power Supply; or,
  • Tilted Handset. Keep the Handset level, gently tap the Handset and restart the Controller.

Lamira does not stop automatically after all the ARIKAYCE® is consumed.

Clean and disinfect the Aerosol Head. If the condition continues, contact ARIKARES at 1-833-274-5273.

Longer than normal nebulization time.

 The Aerosol Head is dirty. Clean and Disinfect the Aerosol Head. Replace the Aerosol Head with a new one from the Drug Kit after 7 uses.

The Handset leaks.

Consider the following:

  • Make sure Blue Valve is placed correctly in the Handset and the 2 flaps point into the Handset Chamber;
  • Make sure Aerosol Head is correctly placed in the Handset; and,
  • If the Blue Valve and Aerosol Head are correctly placed, note that it is normal to have some liquid collect in the Aerosol Chamber and Mouthpiece. The amount depends on the volume of the ARIKAYCE® and on the breathing pattern.

The On button was accidently pressed for 10 seconds, which activated the easycare function. Easycare is an accessory that assists in cleaning the Aerosol Head but it is not used for ARIKAYCE®. Press the On/Off button briefly to turn-off the Controller and stop the easycare function.



Progress Check Questions

Answer the following Progress Check Questions to see how much you recall from the materials you reviewed. When you are finished, be sure to select the “Get Course Credit” button to receive credit.
  1. Q1
  2. Q2
  3. Q3
  4. Q4
  5. Q5
  6. Q6
  7. Q7
  8. Q8
  9. Q9
  10. Q10
  11. Q11

Which of the following comes in the Lamira Carrying Case? (Select all that apply.)





In each 28-Day Drug Kit, patients receive:





Which of the following are steps involved in assembling the Handset? (Select all that apply.)





When should patients clean and disinfect their Lamira Handset and Aerosol Head?





Which statement about disinfecting the Aerosol Head and Handset is true? (Select all that apply.)


cleaning them is insufficient.



of bacteria, which increases the risk of infection or serious illness.


the medication and saliva.

Of the following, which items are important for patients to remember when assembling the handset? (Select all that apply.)




Suspension”


Which of the following statements about taking ARIKAYCE® is false?





that drug.

How long should patients shake their vial of ARIKAYCE® before adding it to
the Medication Reservoir?





If Lamira is cleaned and maintained properly, approximately how long will it take patients to complete treatment with ARIKAYCE®?





What happens if patients hold the Handset at an angle over 45 degrees while taking ARIKAYCE®?





When cleaning the Handset, patients will do all of the following except:




water to a clean tub or bowl.


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