PureSleep Anti-Snoring Mouthpiece Instruction Manual (Model PSKITC1)

1. Product Overview

The PureSleep Anti-Snoring Mouthpiece is designed to reduce snoring by gently holding your lower jaw slightly forward of its normal resting position during sleep. This action helps to open the upper airway, improving airflow and reducing tissue vibration that causes snoring. PureSleep is an FDA-cleared device for over-the-counter use, indicating its proven safety and effectiveness when used as directed.

Image: The PureSleep device, its packaging, and instruction booklet.

2. Important Safety Information

WARNING: This device is not suitable for individuals under 18 years of age.

Contraindications: Do NOT use PureSleep if you:

• Are under 18 years of age.
• Are undergoing orthodontic treatment.
• Have had a dental implant within the last three months.
• Have chronic severe asthma, emphysema, COPD, or any other serious breathing or respiratory disorder.
• Have been diagnosed with central sleep apnea (a neurological disorder, distinct from obstructive sleep apnea).
• Have been diagnosed with temporomandibular joint disorder (TMD) or experience symptoms such as clicking, popping, grating, or locking of your jaw, or jaw pain when opening your mouth, yawning, or chewing.
• Experience jaw or tooth pain from clenching your jaw or grinding your teeth.
• Have loose, damaged, or weakened teeth, loose fillings, or loose caps.
• Have abscesses, severe mouth sores, bleeding gums, or severe gum disease.
• Have full dentures (partial dentures are acceptable if healthy molars are present on each side of the top and bottom arches).
• Are currently using another dental appliance for sleep.

Potential Side Effects:

Use of this device may cause tooth movement, bite change, gum or tooth soreness, pain or soreness of the temporomandibular (jaw) joint or a worsening of TMD symptoms, and excessive salivation. You may also experience reduced ability to breathe through your mouth as easily. If you experience difficulty breathing or if other respiratory disorders exist or continue, stop using PureSleep and consult a physician immediately. PureSleep is not indicated for the treatment of obstructive sleep apnea.

Image: A detailed list of conditions for which PureSleep should not be used.

3. Setup and Customization

The PureSleep device is designed for custom fitting to maximize comfort and effectiveness. A detailed step-by-step instruction guide is included in your PureSleep kit to walk you through the process in less than ten minutes.

Fitting Process:

1. Prepare the Device: The PureSleep device consists of two components. Ensure they are correctly aligned as per the included guide.
2. Boil and Mold: Immerse the device in boiling water for the recommended duration (typically 2 minutes, refer to your specific guide). This softens the material for molding.
3. Custom Impression: Carefully remove the softened device from the hot water. After allowing it to cool slightly (usually 15 seconds, as per instructions), place it in your mouth and bite down firmly. Simultaneously, push your lower jaw slightly forward to achieve the desired mandibular repositioning. Use your fingers to press the material against your teeth for a snug fit.
4. Cool and Set: Hold the position for the specified time, then remove the device and immerse it in cold water to set the impression.

It may take a few nights to fully acclimate to wearing the device. Initial soreness or an unusual feeling on your teeth is common but should subside. If discomfort persists, consult your dental professional.

Image: The PureSleep device, showing its two-piece design, ready for the fitting process.

Instructional Video:

Video: A detailed guide from The Pure Sleep Company on how to properly fit and use the PureSleep Anti-Snoring Mouthpiece for optimal results.

4. Operating Your PureSleep Device

Once customized, the PureSleep device is ready for nightly use. It works by gently holding your lower jaw forward, which prevents the soft tissues at the back of your throat from collapsing and obstructing your airway. This mechanism reduces or eliminates the vibrations that cause snoring.

How it Works:

• The device repositions the lower jaw, creating an open airway.
• Improved airflow reduces the likelihood of snoring.
• The patented, low-profile mechanism minimizes vertical jaw position without bulky components.

Image: Illustration demonstrating how the PureSleep device repositions the jaw to open the airway.

Usage Tips:

• Wear the device every night for consistent results.
• It may take a few nights to become accustomed to the sensation of wearing the device.
• If you experience any discomfort, ensure the device is properly fitted according to the instructions.

Mechanism Explanation Video:

Video: A short explanation from The Pure Sleep Company detailing how the device works to eliminate snoring.

5. Care and Maintenance

Proper care of your PureSleep device ensures hygiene and extends its lifespan.

Cleaning Instructions:

• After each use, rinse the device thoroughly with cool water.
• Brush the device gently with a toothbrush and mild soap or a non-abrasive denture cleaner. Avoid using toothpaste, as it can be abrasive.
• Rinse again thoroughly to remove any cleaning residue.
• For deeper cleaning, you may soak the device with a retainer cleaning tablet every few days.

Storage:

Store your PureSleep device in the provided handy ventilated storage case when not in use. This protects it from damage and allows it to air dry, preventing bacterial growth.

Image: The PureSleep device stored in its white, ventilated case.

Replacement:

It is recommended to replace your PureSleep device every 6-8 months, or sooner if it shows signs of wear, damage, or becomes discolored.

6. Troubleshooting

If you encounter issues with your PureSleep device, consider the following:

Discomfort or Soreness:

• Initial Adjustment: It is normal to experience some tooth or jaw soreness during the first few nights of use. This typically subsides as your mouth adjusts.
• Refitting: If discomfort persists or is significant, the device may not be perfectly fitted. Review the customization instructions and consider a careful refitting if the material allows.
• Excessive Jaw Forwarding: Ensure you did not push your jaw too far forward during the molding process. This can cause undue strain.
• Consult a Professional: If pain or discomfort continues after several nights of use, or if you suspect a more serious issue, discontinue use and consult your dentist or physician.

Device Not Reducing Snoring:

• Proper Fit: A loose or improperly fitted device may not effectively reposition your jaw. Ensure a snug and secure fit.
• Underlying Conditions: Snoring can be a symptom of more serious conditions like obstructive sleep apnea. If PureSleep does not alleviate your snoring, or if you experience other symptoms like gasping for air during sleep, excessive daytime sleepiness, or morning headaches, consult a healthcare professional for a comprehensive evaluation.
• Device Type: While effective for many, no single anti-snoring solution works for everyone. Your specific anatomy or the nature of your snoring may require a different approach.

7. Product Specifications

8. Warranty and Customer Support

The Pure Sleep Company offers an unconditional, money-back 60-day guarantee to ensure your complete satisfaction. Please note that due to hygiene reasons, snoring mouthpieces are generally not returnable to retailers like Amazon, but the manufacturer's guarantee provides direct recourse.

Contacting Support:

For warranty claims, product inquiries, or further assistance, please refer to the contact information provided in your PureSleep instruction booklet or visit The Pure Sleep Company's official website.