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Indications for Use1
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® Airway Clearance System has been prescribed by your physician for your use only. Do not let others try on your device, whether it is turned 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). See the Contraindications section in the manual for further description of an active implantable medical device.
For a complete list of Warnings or to obtain a copy of the User Manual, please call us at 800-426-4224.
1The Monarch Airway Clearance System Model 1000 User Manual (195292).