CareFusion ApneaRx Micro-Adjustable Sleep Apnea Appliance
CareFusion ApneaRx Micro-Adjustable Sleep Apnea Appliance
This oral appliance is a solution for those with mild sleep apnea or those who cannot work with traditional CPAP therapy. By repositioning the jaw, the ApneaRx Micro-Adjustable Sleep Apnea Appliance not only helps to open your airway to help you breathe easier, but also reduces snoring.
Contents of Package: ApneaRx Micro-Adjustable Sleep Apnea Appliance
Description: The ApneaRx is recommended by the American Academy of Sleep for treatment of mild sleep apnea or for those who cannot tolerate traditional CPAP therapy. This oral appliance works by repositioning the lower jaw to prevent airway collapse, ensuring you breathe easily throughout the night. The easily customized appliance is fitted much like a mouthguard, boiled until soft and fitted into the mouth, creating a custom fit. The MicroFit, millimeter by millimeter adjustment increments can be done by you, no need to go back to your doctor!
ApneaRx's small size makes it ideal for travel, able to fit virtually anywhere. With no need for power cords or bulky machines, this oral appliance is perfect for anyone on the go. It is also a good alternative for anyone without insurance, as traditional machines and masks can cost up to one thousand dollars total! Be sure to consult with your doctor to see if the ApneaRx is a viable option to treat your OSA.
Product Skus: 22543-001
How Does ApneaRx Work?
ApneaRx works by a technique called ‘mandibular repositioning’ in which it advances and holds the lower jaw in a forward position so that the airway is opened at night. This improves breathing and reduces snoring and sleep apnea. ApneaRx is unique in that it allows the patient to micro-calibrate the setting of the forward advancement at any time to achieve a custom comfortable fit. This is very important to achieve optimal clinical success and patient comfort.
Are Oral Appliances Effective in Reducing Sleep Apnea?
The American Academy of Dental Sleep Medicine (AASM) has recently identified oral appliances as an effective treatment for OSA. The AASM states that an oral appliance should be the first line therapy for mild to moderate sleep apnea and CPAP intolerant patients. A recent randomize clinical study of 108 patients performed by Peter Cistulli, MD at the University of Sydney, Australia demonstrated that CPAP and oral appliances have an equivalent health outcome given CPAP’s greater efficacy is off set by more patient compliance with oral appliances.
What are the Potential Consequences if Treatment for Sleep Apnea is Ignored?
Neglect in treating sleep apnea may result in life threatening medical disorders. Not pursuing treatment may lead to morning headaches, impotence, gastro esophageal reflux, nocturnal bruxism, and mortality. Cardiovascular effects may include high blood pressure, cardiac arrhythmias, heart attack, stroke, increased cholesterol, and atherosclerosis.
Why ApneaRx vs Other Oral Appliances?
The Medicare Product Design Standards published November 11, 2010 indicated that an oral appliance should provide the patient the ability to advance the lower jaw in 1 mm increments, up to 10 mm at any time. ApneaRx is the only boil and bite oral appliance that accomplishes this without the use of screws, wires, nuts, bolts, rubber bands, etc. Thus more patient comfort and clinical efficacy is achieved.
Does ApneaRx Require a Prescription?
Yes. ApneaRx is a Class II medical device which requires a prescription from a licensed medical practitioner. Sleep MDs, dentists, general practitioners are the most likely medical practitioners to prescribe ApneaRx. Local or internet durable medical equipment (DME) dealers can help the patient obtain a prescription for ApneaRx from medical practitioners of the patient choice.
Is ApneaRx Safe?
Mandibular repositioning to reduce snoring and sleep apnea has been safely prescribed by dentists and physicians for several decades. Since ApneaRx is adjustable if can be better fitted to the patient to avoid potential problems – like TMJ. As with all products, you should carefully read and follow all instructions and labeling before use.
Does ApneaRx Cause TMJ and Pain After Use?
No! Unlike other products that lock your jaw into a setting, ApneaRx’s design provides micro- calibration to insure against TMJ. If your jaw feels uncomfortable, just reduce the advancement of ApneaRx until more comfortable. It pain continues, discontinue use immediately and contact your health care professional.
Is ApneaRx Easy to Fit?
Fitting is quick and easy. All you do is immerse the device in boiling water for 90 seconds. After dipping it in cool water for a couple of seconds, ApneaRx is placed in your month and self molded for 30 seconds. This process can be repeated 2-3 times. A step-by-step Instruction Guide is included in the ApneaRx kit, and we highly suggest it be read in detail before fitting ApneaRx.
Why is ApneaRx too Big?
Currently ApneaRx only comes in one size. About 20% of patients’ months are too small for the currently sized ApneaRx. We will eventually have 2 sizes that will accommodate most patients.
What is the Best Way to Adjust ApneaRx? (see inside cover lid for detailed instructions)
It is important to adjust ApneaRx after it has been fitted at the factory setting of 3mm. The thermal fitting process will help to secure the molded material to the jaw trays. To adjust the lower jaw tray forward - simply stabilize the upper tray with you left hand forming a “P” shape with your left thumb. Simultaneously push in the 2 sides of the lower tray with your right thumb and trigger finger (where is says PUSH) and use your left thumb to help push the lower tray forward. This can also be done by forcing and clicking the lower tray forward by 1mm increments. To adjust the lower tray backwards – it will help to know that ApneaRx is locked by ratchets. A backwards rocking motion is required to move the lower jaw tray around the ratchets.
What do I do if the moldable thermal inserts come loose?
Do no worry. The moldable material (Elvax) inserts are heat staked into fastening holes located at the bottom of the jaw trays. If by chance they are dislodged before the Elvax material is molded into the tray when boiled, just push the stakes back into the holes and continue with the fitting process. Once the Elvax material is boiled it adheres to the trays and dislodging it is difficult. If the stakes can not be re-inserted into the tray’s fastening holes, return ApneaRx for a replacement. Tip – Boil ApneaRx at the 3 mm factory setting before adjustments are made. Dislodging of the Elvax inserts are rare once ApneaRx has been boiled.
How Long Does it Take to Feel Comfortable with ApneaRx?
Typically, the adjustment period takes about 3-5 nights of consistent use. It is perfectly normal for your jaw, teeth and gums to feel moderately sore and fatigued at first. This discomfort is much like getting braces or a retainer for the first time. However, it is not normal to experience severe, sharp or ongoing pain. These symptoms may be an indication of a more serious problem with your jaw called temporomandibular disorder (TMD). If you experience these symptoms or believe you have TMD, discontinue use immediately and contact your health care professional.
Can I Breathe through My Mouth while Wearing ApneaRx?
Yes! ApneaRx lets you breathe completely naturally, through your mouth and nose. We recommend you do not buy any device that restricts breathing through your mouth or nose.
How Do I Clean my ApneaRx?
Clean ApneaRx in warm water with mild dish soap. For best results, use a toothbrush; however, do not use toothpaste, as it tends to discolor and alter the surface of the device. Rinse thoroughly to remove all soap prior to storage.
How Do I Store my ApneaRx?
Store your cleaned ApneaRx in the supplied case. This ensures that it will retain its shape and prevent accidental damage.
How Often Should ApneaRx be Replaced?
Each ApneaRx undergoes normal wear and tear through the course of nightly use. We recommend replacing the unit every 12-15 months. Some individuals grind their teeth (bruxism), more than others and therefore may need to replace it more often.
What are Frequent Causes for Returns?
It is common that most people make the mistake of trying the device right out of the box. And thus they return the item. ApneaRx is a CUSTOM FIT device and is intended to be boiled before being used. Do not use ApneaRx without boiling it to a CUSTOM FIT first.
I tried using a CPAP machine but couldn't fall asleep with it so I had to stop. My doctor told me about this when it came on the market and I've used it since. It took a little getting used to because it fits like a mouthguard, but I don't even notice it anymore.
- Tom, PA
Submitted on January 7, 2014
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