The PODs operate in a pattern designed to loosen mucus and help clear your patients’ airways.
Airflow moves the mucus from small to large airways, where they can be coughed or suctioned out.
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® Airway Clearance 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.7
connection you can feel good about
When you are closely connected to your patients, you can make better decisions together. That’s why the Monarch® System integrates with the Hillrom™ Connex® App and Health Portal—giving you both easy access to daily therapy session results. Your patients can also use the app to track everything from medications and Pulmonary Function Tests (PFTs) to nutrition, exercise and more—rewarding healthy behaviors and empowering them to feel their best.
Indications and important safety information
Indications for Use8
The Monarch® Airway Clearance System is intended to provide airway clearance therapy and promote bronchial drainage where external manipulation of the thorax is the physician’s choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging. The Monarch System is intended to be used in the Home Care environment by patients, 15 years and older.
If any patient conditions exist that could cause the use of Monarch Airway Clearance System, Model 1000 to present a risk to the patient, do not use the unit except as directed by a physician. Death or serious injury could occur.
Monarch Airway Clearance System, Model 1000 is contraindicated if these conditions are present:
- The Monarch® device uses Pulmonary Oscillating Discs (PODs) that create a magnetic field which is present whether the device is turned on or off. Due to the presence of the magnetic field, people who have an active implantable medical device, such as any of the following, are contraindicated (if they cannot keep the susceptible component at least 6 inches away from the Monarch® device):
- Infusion Pumps, including Insulin Pumps
- Circulatory Support Devices
- Implantable Cardioverter Defibrillators (ICDs)
- Head and/or neck injury that has not yet been stabilized.
- Active hemorrhage with hemodynamic instability.
The Monarch Airway Clearance System warnings include:
- Patients that may have difficulty clearing secretions from the upper airway (such as those with DMD or other advanced neuromuscular or neurological disorders) may require specialized therapy regiments involving manually or mechanically assisted coughing or other techniques in conjunction with Monarch® Airway Clearance System, Model 1000 therapy. Please consult your physician to determine if additional therapy is appropriate.
- The Monarch System is prescribed by a physician for an individual patient’s use only. No one else should every try on the device, whether it is on or off. It should never be worn or used by someone with an active implantable medical device due to the presence of the magnetic field created by the Monarch® Pulmonary Oscillating Discs (PODs).
For a complete list of Warnings or to obtain a copy of the User Manual, please call us at 800-426-4224.
For more detailed product information, visit the Hillrom website.
- 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 MonarchTM 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® 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.
- Sound testing per International Standard IEC 60601-1, 3rd Edition at a distance of 30 cm. Sound testing results found the Monarch System operates at a level at or below that considered as a “normal conversation”; reference https://www.nidcd.nih.gov/health/noise-induced-hearing-loss.
- 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.
- Leemans G, De Hondt A, Ides K, et al. Evaluation of a mobile HFCWO device in patients with cystic fibrosis. Pediatric Pulmonology. September 2018;53(S2):S1-S481.
- The Monarch Airway Clearance System Model 1000 User Manual (195292).
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202762 rev 5 07-OCT-2020 ENG – US