Healthcare Professionals Overview
Breathe Easy Knowing They Will Too
Imagine how your patients’ lives could change if they were given the freedom to do their airway clearance therapy while still doing everyday activities. That’s exactly what our Monarch Airway Clearance System is designed to do. The Monarch System employs revolutionary technology to provide High Frequency Chest Wall Oscillation (HFCWO) therapy in a mobile way. Now your patients can move about freely even as they receive targeted kinetic energy and airflow to thin and mobilize airway secretions.
The Monarch System is a HFCWO therapeutic device with revolutionary technology. This vest therapy clears the airways by combining mobility with targeted kinetic energy and airflow to thin and mobilize secretions. Because when patients can move about freely during therapy, they can take control of their therapy—and their lives.
Mobile
A rechargeable battery powers therapy on the move.
Move Mucus
A study shows that the Monarch System aids in sputum production.1
Connected
Connected portal helps patients share therapy results with their care team.
Powered by PODs
The Monarch System’s eight Pulmonary Oscillating Discs (PODs) are positioned to deliver targeted kinetic energy to the upper and lower lungs. This targeted therapy generates airflow helping to thin mucus and mobilize secretions from the small airways to the large airways, from which they can be coughed or suctioned out to help improve your patient’s airway clearance.2-9
PODs operate in a pattern designed to loosen mucus and optimize the airway clearance effect.
Airflow moves the mucus from small airways toward the large airways, from which they can be more easily expelled or removed.
Connection You Can Feel Good About
The Connex Health Portal from Baxter helps patients and clinicians clearly see day to day therapy results, so they can make informed decisions together.
Meet the Mind Behind the MONARCH System: Marten Devlieger
Marten Devlieger and his sister were both born with cystic fibrosis (CF). As they grew up, their mother had to manually administer chest physiotherapy (CPT) to them, to help clear their airways. But Marten envisioned a life with more independence. He created a mobile therapeutic device to provide him with the airway clearance therapy he needed. It freed him to travel, to pursue his love of kite-surfing, to have adventures, and to raise his own family. And when Marten told us that he wanted others to experience the flexibility and control he’d claimed for himself, we gladly partnered with him to develop the Monarch Airway Clearance System.
Watch a brief video to learn more.
Take a quick tour of the functions, features, and benefits of this non-invasive device for HFCWO therapy.
CARE CONNEX Program
Baxter created the CARE Connex Program to deliver comprehensive services at every step of the patient journey, offering new efficiencies for your practice and helping improve the therapy experience for patients.
We work with over a thousand leading local, regional, and national companies to include commercial health plans and networks, Medicaid, Medicare, TRICARE and the Department of Veterans Affairs.
For further information about the MONARCH System, please contact your Baxter sales representative or call Baxter customer service at 1-800-426-4224.
Rx Only. For safe and proper use of product mentioned herein, please refer to the Instructions for Use or Operator Manual.
- Leemans G, Belmans D, Van Holsbeke C, et al. The effectiveness of a mobile high-frequency chest wall oscillation (HFCWO) device for airway clearance. Pediatr Pulmonol. 2020;55:1984–92.
- Data on File at Baxter International Inc.
- NIDCD Fact Sheet: Hearing and Balance. Noise-Induced Hearing Loss. National Institute on Deafness and Other Communication Disorders. NIH Pub. No. 99-4233. March 2014. Accessed March 7, 2024. https://www.nidcd.nih.gov/health/noise-induced-hearing-loss
- Bench testing conducted in 2017. Testing was performed at the following therapy settings: The Vest System Model 105 and the Monarch System Model 1000 with intensity/pressure set at 10, frequencies settings at 5, 14, and 20 Hz; the AffloVest System was tested at the “Vibration” setting at “Low”, Medium” and “High” settings, which according to the AffloVest System web site operate at 5Hz, 13Hz, and 20Hz respectively. The AffloVest Systems used were labeled as REF 8200 and 8300. Testing consisted of measuring impulse force, or applied force over a timeframe of 30 seconds, via 4 force sensors placed on a mannequin in upper and lower chest locations. Comparisons are not based on head to head clinical efficacy or safety studies.
- Independent lab testing conducted in 2017. Data was analyzed and compared average pulse airflows at the mouth generated by high frequency chest wall oscillation (HFCWO) therapy in 10 human subjects using home care garments. Airflows were measured via pneumotachometer at settings of the following: The Vest System Model 105 and the Monarch System Model 1000 with intensity/pressure set at 10, frequencies settings at 5, 10, 15, and 20 Hz; the AffloVest System was tested at the “Vibration” setting at “Low”, Medium” and “High” settings, which according to the AffloVest System web site operate at 5Hz, 13Hz, and 20Hz respectively. The AffloVest Systems used were labeled as REF 8200 and 8300. Comparisons are not based on head to head clinical efficacy or safety studies. Airflow test subjects were adult males with healthy lung function. Results for female subjects and patients with lung disease may vary from those in this study.
- King M, Phillips D, Gross D, Vartian V, Chang HK, Zidulka A. Enhanced tracheal mucus clearance with high frequency chest wall compression. Am Rev Respir Dis. 1983; 128:511-5.
- Dosman CF and Jones RL. High-frequency chest compression: a summary of the literature. Can Respir J. 2005. 12(1): p. 37-41.
- Freitag L, et al. Removal of excessive bronchial secretions by asymmetric high-frequency oscillations. J Appl Physiol. 1989; 67: 614-9.
- McCarren B, Alison JA. Physiological effects of vibration in subjects with cystic fibrosis. Eur Resp J. 2006; 27: 1204-9.
Baxter, CARE Connex, Hillrom, and Monarch are trademarks of Baxter International Inc. or its subsidiaries.
US-FLC115-240007 (v1.0) 12/2024
Patient Overview
Freedom to Move About Your Life
It can be hard to fit therapy into your life, even though you know how important it is. People like you are taking control of their lives with the Monarch Airway Clearance System. By allowing you to move freely, the Monarch Airway Clearance System opens a new world of possibilities for doing your therapy, your way.
We’re excited about that new world—because for nearly 35 years, helping people with chronic respiratory diseases and conditions has been a big part of who we are at Baxter.
Leap Forward
Inspired by patients, the Monarch System uses a revolutionary mobile technology to help clear your airways while allowing you to move about freely.
Cut Loose
You can get the mobility and flexibility to do your therapy while fitting more into your day. You can do more of the things you love and take more control of your life.
Take Off
This system is designed to travel easily with you. Take it with you camping, to the airport, wherever you need to go. It’s for someone on the move—like you.
Mobility Powered by POD Technology
The Monarch System uses Pulmonary Oscillating Discs (PODs) to generate oscillations and targeted kinetic energy to your lungs. This airway clearance therapy helps thin mucus and increase airflow, mobilizing secretions from the airways while you’re going about your day. So, you no longer have to put your life on hold for therapy.
Front and back PODs operate in a pattern to optimize oscillatory effect to the airways.
Oscillating PODs deliver targeted kinetic energy and generate airflow in the lungs to loosen mucus.
Air gets behind the mucus to move it to the large airways.
Meet the Mind Behind the MONARCH System
Marten Devlieger and his sister were both born with cystic fibrosis (CF). As they grew up, their mother had to manually perform chest physiotherapy (CPT) to them, to help clear their airways.
But Marten envisioned a life with more independence. He created a mobile therapeutic device to provide him with the airway clearance therapy he needed. It freed him to travel, to pursue his love of kitesurfing, to have adventures, and to raise his own family.
And when Marten told us that he wanted others to experience the flexibility and control he’d claimed for himself, we gladly partnered with him to develop the Monarch Airway Clearance System.
Why Airway Clearance Is Important
When mucus cannot be cleared from the lungs, it builds up and creates an environment in which bacteria can grow. This can lead to repeated, serious lung infections, which can cause more damage to the airways of the lungs and a vicious cycle of infection. This cycle may lead to irreversible lung damage and respiratory failure.
If you need to manage treatment for a chronic respiratory disease or condition, you know airway clearance therapy is important.
Airway Clearance Techniques (ACTs) loosen thick, sticky mucus so it can be cleared from the lungs by coughing or huffing. These techniques include chest physical therapy, sometimes provided with the help of a caregiver. High-frequency chest wall oscillation devices gently compress and release the chest wall which creates airflow within the lungs. This type of therapy traditionally involves an inflatable garment that is worn and attached to an air pulse generator that rapidly inflates and deflates the garment. The Vest Airway Clearance System from Baxter uses this type of therapy and has helped thousands of patients dealing with respiratory insufficiency get airway clearance.
Diseases Of Respiratory Insufficiency
Respiratory insufficiency refers to conditions that reduce your body’s ability to perform gas exchange, including:
- Cystic Fibrosis (CF): is an inherited genetic condition where a faulty protein causes mucus to become thick and sticky. When mucus builds in affected organs of a patient with Cystic Fibrosis, it can cause infections, blockage or damage. Patients with Cystic Fibrosis can have difficulties clearing mucus from their airways which can lead to damaged, widened airways, otherwise known as the condition bronchiectasis.3
- Neuromuscular Disease: refers to conditions that affect the nerves and muscles that control breathing. Examples include amyotrophic lateral sclerosis (ALS), often called Lou Gehrig’s disease; muscular dystrophies; and myasthenia gravis. As these conditions progress, loss of nerve function can lead to difficulty in breathing and respiratory insufficiency.
- Bronchiectasis (brong-ke-EK-ta-sis) (BE) is a condition where the lungs’ airways are abnormally stretched and scarred, resulting in mucus buildup. Often it is caused by an infection or other condition that injures the walls of the airways or prevents mucus from being cleared.
Your One-Stop Destination for Managing Your Therapy
Now, the Monarch System comes connected to the Connex Health Portal, so you and your care team have a clear picture of what’s going on with your day-to-day therapy. That’s important for your health, because it helps you stay on track and keeps your care team in the loop, so you can make informed treatment decisions together.
Designed with You In Mind
Sportswear-inspired design gives you freedom of mobility. Quiet operation allows normal conversation.1,2 Pendant control simplifies system operation for you. Rechargeable battery conveniently powers your therapy.
What’s Included
Mobile garment
with 8 independently operating PODs delivering targeted kinetic energy.
Pendant control
is intuitive and simple to use.
Vest shell
in your choice of five colors; washable & dryable.
Rolling carrying case
with retractable handle and backpack straps looks like ordinary luggage and makes it easy to travel with the device.
Rechargeable battery
powers therapy on the move.
Power adapter and cord
Connex connectivity
One-stop control center where your doctor can help manage your therapy decisions.
Is it right for me?
The Monarch Airway Clearance System is cleared by the FDA to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician’s choice of treatment. The Monarch System can help people living with diagnoses such as:
Chronic Pulmonary
– Bronchiectasis, Cystic Fibrosis and Primary Ciliary Dyskinesia
Neuromuscular
– Cerebral Palsy, Muscular Dystrophy, Spinal Muscular Atrophy, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Stable Quadriplegia and Paralysis of Diaphragm
How do I obtain a MONARCH Airway Clearance System?
The Monarch System must be prescribed by your doctor. Consult with your doctor to understand if it is right for you.
Insurance Coverage
The Monarch Airway Clearance System is covered by Medicare and commercial insurance plans High Frequency Chest Wall Oscillation (HFCWO) therapy. Find a provider call customer service at 1-800-426-4224 or email at [email protected].
Ask Your Doctor
Ask your doctor about the Monarch System if you have respiratory insufficiency and answer “yes” to any of the following questions:
- Chronic mucus hypersecretion or retention associated with a chronic pulmonary or neuromuscular condition.
- Ineffective cough or inability to remove mucus by coughing.
- Frequent respiratory infection as a result of secretion retention.
- Alternative airway clearance therapy tried and failed or contraindicated.
Watch a brief video to learn more.
Learn all about this mobile, non-invasive HFCWO therapy device.
CARE CONNEX Program
Baxter created the CARE Connex Program to help improve your therapy experience every step of the way. Our team of 200+ professionals is ready to assist you with:
- Understanding your insurance, warranty coverage and financial options available to you
- 24-hour clinical care with multilingual customer service and product support
- Device setup and configuration from licensed clinical trainers
To learn more, talk to your healthcare provider about the MONARCH System.
Rx Only. For safe and proper use of product mentioned herein, please refer to the Instructions for Use or Operator Manual.
- Data on File at Baxter International Inc.
- NIDCD Fact Sheet: Hearing and Balance. Noise-Induced Hearing Loss. National Institute on Deafness and Other Communication Disorders. NIH Pub. No. 99-4233. March 2014. Accessed March 7, 2024. https://www.nidcd.nih.gov/health/noise-induced-hearing-loss
- NHLBI Fact Sheet: WHAT IS CYSTIC FIBROSIS? Cystic Fibrosis. National Heart Lung and Blood Institute. NIH Pub. No. 22-HL-8178. January 2022. Accessed July 7, 2024. https://www.nhlbi.nih.gov/sites/default/files/publications/WhatIsCysticFibrosis.pdf
Baxter, CARE Connex, Hillrom, and Monarch are trademarks of Baxter International Inc. or its subsidiaries.
US-FLC115-240007 (v1.0) 12/2024
Technical Specifications
Dig deeper into product attributes to see how we can fit your requirements.
| Weight | 13 lbs. (with battery) |
| Mid-Torso Circumference | Fits 22" to 50" |
| Base Material | EVA foam |
| Shell Material | Polyester |
| Battery | Lithium-ion |
Rx Only. For safe and proper use of product mentioned herein, please refer to the Instructions for Use or Operator Manual.
Baxter, CARE Connex, Hillrom, and Monarch are trademarks of Baxter International Inc. or its subsidiaries.
US-FLC115-240007 (v1.0) 12/2024
Resources & Documentation
Get in the know to get the most value out of your solution.
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Training Videos
keyboard_arrow_downMONARCH System Training Video
MONARCH System Fit Assessment Video
MONARCH System Prescription Form
Learn how the MONARCH Airway Clearance System supports breathing.
Rx Only. For safe and proper use of product mentioned herein, please refer to the Instructions for Use or Operator Manual.
US-FLC115-240007 (v1.0) 12/2024
Clinical Data
Understanding HFCWO Mechanisms of Action*
Expiratory airflow bias is important, and kinetic energy transferred through the chest wall to the lungs is believed to help loosen secretions adhering to lung tissue.1-6 HFCWO creates kinetic energy designed to increase airflow to help mobilize secretions from the airways.1,2,4,6,7
Impulse Force Testing Results8
Kinetic Energy Delivered to the Chest Wall
Kinetic energy delivered to the chest wall generates airflow to mobilize secretions and is believed to help loosen secretions.8,9 Impulse force was used to evaluate the kinetic energy delivered by an airway clearance system. Measuring this force applied over an acute period of time provides insight to the energy transfer through a chest wall to lung tissue.
Airflow Testing Results9
Airflow to Mobilize Secretions
Pulse airflow was used to evaluate the airflow created by different airway clearance systems. Each pulse of airflow at the mouth was measured via software customized to measure oscillating airflow. Testing shows the Monarch System can generate up to 5x the airflow of the AffloVest System.10 **
Summary of Impulse Force and Airflow Testing8,9
* Comparisons are not based on head-to-head clinical efficacy studies. The clinical significance of these differences has not been established. Airflow test subjects were adult males with healthy lung function. Results for female subjects and patients with lung disease may vary from those in this study.
Clinical Results
Data from a clinical evaluation of the Monarch Airway Clearance System by Leemans G., et al., were presented at the 2018 North American Cystic Fibrosis Conference (NACFC). The researchers reported the Monarch System was comparable to The Vest System for sputum production. Post-therapy evaluations of the Monarch System showed statistically significant improvement in Brody scores and FRI results, suggesting the device's relative airway clearance effectiveness.11
Comparison of Wet Sputum Weight, MONARCH System vs. THE VEST System (P=0.77)11
Brody Scores and FRI Measurements for the MONARCH System
Download the clinical research summary to learn more.
Leemans Fluidda Monarch System Clinical Research Summary
Rx Only. For safe and proper use of product mentioned herein, please refer to the Instructions for Use or Operator Manual.
- King M, Phillips D, Gross D, Vartian V, Chang HK, Zidulka A. Enhanced tracheal mucus clearance with high frequency chest wall compression. Am Rev Respir Dis. 1983; 128:511-5.
- Dosman CF and Jones RL. High-frequency chest compression: a summary of the literature. Can Respir J. 2005. 12(1): p. 37-41.
- Freitag L, et al. Removal of excessive bronchial secretions by asymmetric high-frequency oscillations. J Appl Physiol. 1989; 67: 614-9.
- McCarren B, Alison JA. Physiological effects of vibration in subjects with cystic fibrosis. Eur Resp J. 2006; 27: 1204-9.
- Murray M, et al. Critical Care Medicine Perioperative Management Second Edition by Lippincott Williams & Wilkins. 2002: p. 435.
- Chest physical therapy. www.healthofchildren.com/C/Chest-Physical-Therapy.html. Accessed March 19, 2024.
- Kendrick A. Airway Clearance Techniques in Cystic Fibrosis: Physiology, Devices and the Future, Cystic Fibrosis. InTech, 2012. Available from https://www.intechopen.com/books/cystic-fibrosis-renewed-hopes-through-research/airway-clearance-techniques-in-cystic-fibrosisphysiology- devices-and-the-future.
- Bench testing conducted in 2017. Testing was performed at the following therapy settings: The Vest System Model 105 and the Monarch System Model 1000 with intensity/pressure set at 10, frequencies settings at 5, 14, and 20 Hz; the AffloVest System was tested at the “Vibration” setting at “Low”, Medium” and “High” settings, which according to the AffloVest web site operate at 5Hz, 13Hz, and 20Hz respectively. The AffloVest Systems used were labeled as REF 8200 and 8300. Testing consisted of measuring impulse force, or applied force over a timeframe of 30 seconds, via 4 force sensors placed on a mannequin in upper and lower chest locations. Comparisons are not based on head to head clinical efficacy or safety studies.
- Independent lab testing conducted in 2017. Data was analyzed and compared average pulse airflows at the mouth generated by high frequency chest wall oscillation (HFCWO) therapy in 10 human subjects using home care garments. Airflows were measured via pneumotachometer at settings of the following: The Vest System Model 105 and the Monarch System Model 1000 with intensity/pressure set at 10, frequencies settings at 5, 10, 15, and 20 Hz; the AffloVest System was tested at the “Vibration” setting at “Low”, Medium” and “High” settings, which according to the AffloVest System web site operate at 5Hz, 13Hz, and 20Hz respectively. The AffloVest Systems used were labeled as REF 8200 and 8300. Comparisons are not based on head to head clinical efficacy or safety studies. Airflow test subjects were adult males with healthy lung function. Results for female subjects and patients with lung disease may vary from those in this study.
- Data on File at Baxter International Inc.
- Leemans G, Belmans D, Van Holsbeke C, et al. The effectiveness of a mobile high-frequency chest wall oscillation (HFCWO) device for airway clearance. Pediatr Pulmonol. 2020;55:1984–92.
Baxter, CARE Connex, Hillrom, Monarch and The Vest are trademarks of Baxter International Inc. or its subsidiaries.
AffloVest is a registered trademark of Tactile Medical.
US-FLC115-240007 (v1.0) 12/2024
Frequently Asked Questions
Expand All-
How do I ensure the MONARCH System fits my patients properly?
keyboard_arrow_downA licensed, professional Baxter trainer will come to your patient's home to provide a personalized fitting and Monarch System training. Afterward, your patient may need additional fit adjustments as the Monarch System’s device's foam conforms to his or her body. If you have any questions about device fit, please call Baxter Customer Service at 800-426-4224.
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What are the MONARCH System's maintenance requirements?
keyboard_arrow_downAlthough the Monarch System requires no general maintenance, its cleaning guidelines are listed in its User Manual.
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Are the shells machine-washable and dryable?
keyboard_arrow_downYes. The vest shell can be machine-washed and tumble-dried on low heat. The shoulder pads, backpack cover, and POD covers should be wiped down with an approved cleaner. Refer to the Monarch System's User Manual for full cleaning guidelines.
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How does the MONARCH System provide therapy to the entire lung when the PODs are only touching the torso in eight places?
keyboard_arrow_downExcellent question. The Monarch System employs a clearance therapy known as High Frequency Chest Wall Oscillation (HFCWO) to thin and mobilize secretions from the airways and help improve respiratory health. Its Pulmonary Oscillating Discs (PODs) deliver targeted kinetic energy to both lungs' upper and lower lobes, front and back. This helps to thin mucus and increase airflow throughout the lungs. That stronger airflow can get behind secretions, lift them away from airway surfaces, and move them along from the small airways to the large airways, from which they can be coughed or suctioned out.
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How does the MONARCH System's therapy differ from that of THE VEST System?
keyboard_arrow_downBoth provide HFCWO therapy to clear the airways. Whereas The Vest System uses an airbladder system to deliver airflow-generating energy over the entire chest wall, the Monarch System uses its magnet-containing PODs deliver energy to specific regions of the lungs' upper and lower lobes, therefore wearing a Monarch System garment may feel different from wearing a vest garment. The Monarch System's targeted kinetic energy likewise thins mucus and generates airflow to mobilize secretions.
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Do health insurance companies typically cover the MONARCH System?
keyboard_arrow_downContact your (or your patient's) insurance company to determine coverage for High Frequency Chest Wall Oscillation (HFCWO) devices. The Monarch System is intended for patients who are 15+ years old.
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How often does Baxter contact MONARCH patients?
keyboard_arrow_downA member of the Baxter Respiratory Health’s clinical staff will periodically call the patient to discuss how the system is working for him or her and to answer any questions. Insurance providers may request this data to ensure that the device is being used.
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Can I travel on an airplane with the MONARCH System?
keyboard_arrow_downWhen traveling with the Monarch System, it's recommended that patients review the latest medical device regulations on the U.S. Transportation Security Administration's website (www.tsa.gov). The Monarch System has a lithium-ion battery and current TSA guidelines allow a lithium-ion battery to be included only in carry-on luggage (it may not be included in checked luggage). When a bag is checked at the gate or at plane-side, the Monarch System's battery must be removed and kept with the passenger in the aircraft cabin. The travel agent or airline should be able to answer questions regarding the requirements for traveling with medical devices. Patients might also consider carrying a letter from their physician, stating their medical condition(s) and medical need for the device.
For patient billing and insurance FAQs, click the link below.
Rx Only. For safe and proper use of product mentioned herein, please refer to the Instructions for Use or Operator Manual.
US-FLC115-240007 (v1.0) 12/2024