Sleep Apnea Device Instructions for Use (IFU)

Overview: This article provides instructions for the use, maintenance, and clinical considerations for Dandy Standard Acrylic Herbst,  Freedom Nylon Sleep, and Preferred Nylon Sleep Apnea devices. It includes safety information, step-by-step application guides, and regulatory codes for dental practices.

Device Overview

A Dandy sleep apnea device is a custom dental appliance used to treat snoring and mild to moderate obstructive sleep apnea. These devices, also known as mandibular advancement devices (MAD), work by repositioning the jaw and tongue to keep the airway open during sleep.

Contraindications for Use

Sleep apnea devices may not be appropriate for individuals with the following conditions:

• Severe Respiratory Conditions: Including severe chronic obstructive pulmonary disease (COPD) or severe asthma.

• Dental Issues: Untreated gum disease or extensive tooth decay.

• Jaw Disorders: Severe temporomandibular joint (TMJ) disorders.

Directions for Device Insertion

Follow these steps to ensure the sleep apnea device is seated correctly:

1. Clean Mouth: Have the patient brush and floss their teeth before insertion.

2. Seat Upper Appliance: Place the upper piece of the appliance in the patient’s mouth and have the patient bite down gently to position it.

3. Engage Lower Appliance: * For Herbst devices, the rod and tube assembly will orient the jaws.

   • For Dorsal devices, insert the lower piece after the upper is in place, then adjust the metal connectors.

4. Verify Comfort: Ensure the patient can breathe through their nose and that the device is comfortable.

Adjustment Recommendations for Clinicians On Acrylic Appliances

When adjusting the device, use the following technical standards:

• Equipment: Use a high-speed handpiece with water and air spray to prevent micro-fractures in the material.

• Bur Selection: Use a fine-grit diamond bur. Use a football-shaped bur for occlusal and lingual surfaces; use a tapered bur for buccal surfaces.

• Pressure: Apply minimal pressure during adjustments.

Adjustment Recommendations for Clinicians On Nylon Appliances

This guide outlines the professional clinical protocols for adjusting the retention and physical fit of nylon jaw-repositioning appliances (such as the Panthera Anti-Snoring Device).

Required Equipment & Materials

• Thermal Adjustments: Water heating unit, tweezers, cold water bath, and patient's dental models.
• Mechanical Adjustments: Slow-speed handpiece, carbide laboratory bur, and a hand instrument (for debris removal).

1. General Preparation (Before Adjustments Are Made)

1. Assessment: Examine the patient to identify the specific area or areas requiring adjustment.
2. Disassembly: Detach the titration/retaining rods from the appliance before proceeding with any modifications.
3. Temperature Control: Heat water to a strict target of 85°C to 90°C (185°F to 194°F).
   ⚠️ Important: This temperature range is required to make the nylon material pliable for adjustment without causing permanent deformation or structural damage.

2. Retention Adjustments (Thermal Protocol)

Protocol A: Correcting Low Retention (Increasing Tightness)

If the appliance fits too loosely in the patient's mouth, follow these steps:

1. Heat: Immerse the affected area of the appliance in the hot water bath for approximately 1 minute.
2. Compress: Remove with tweezers and firmly squeeze the walls of the target area inward for about 5 seconds.
3. Set: Immediately submerge the appliance into the cold water bath while maintaining active squeezing pressure.
4. Evaluate: Try the device in the patient's mouth to check the fit. Repeat the sequence if further retention is required.

Protocol B: Correcting High Retention (Relieving a Fit That is Too Tight)

If the appliance is too difficult to insert or remove, follow these steps:

1. Heat: Immerse the appliance in the hot water bath for approximately 1 minute.
2. Expand: Remove the appliance and firmly press it onto the patient's stone dental model, seating it only about 2/3 of the way down.
3. Set: Submerge the appliance and model into the cold water bath while maintaining downward seating pressure.
4. Evaluate: Try the device in the patient's mouth. Repeat the sequence if the fit remains overly tight.

3. Material Reduction (Mechanical Protocol)

Perform this procedure if the patient experiences localized pressure points, discomfort, or pain from specific areas of the rigid plastic.

1. Locate: Precisely identify the high-pressure area(s) inside the splint.
2. Modify: Utilizing a slow-speed handpiece equipped with a carbide lab bur, gently trim away thin, conservative layers of the nylon material.
3. Finish: * Do not polish the internal surface of the appliance, as this can alter the intended surface texture and fit.
   • Use a manual hand instrument to clean away any residual nylon shavings, burrs, or debris.
4. Verify: Frequently assess the modifications by trying the appliance back in the mouth.

💡 Clinical Tip: If a minor, non-painful amount of pressure remains after trimming, instruct the patient to wear the appliance at home for a few days. Allow them to acclimate to the device before performing any additional physical material reduction. and Storage Instructions

To maintain the integrity of the sleep apnea device, follow these hygiene protocols:

• Daily Cleaning: Clean the sleep apnea device daily before and after every use.

• Washing: Use soap and warm water (not exceeding 45°C/113°F).

• Avoid Immersion of Acrylic Appliances: Do not immerse the device in cleaning solutions for extended periods, as this may cause delamination.

  • Nylon Appliances may soak for extended periods

• Storage: Store the device in a dedicated dental case with proper airflow to prevent moisture buildup.

Additional Information

• Clinical studies on sleep apnea devices have shown that they effectively correct malocclusion by promoting forward movement of the lower jaw and improving skeletal alignment. They contribute to improved dental and facial aesthetics and can reduce the need for permanent tooth extractions.
• If the patient experiences any adverse events, such as pain or irritation, they should discontinue use and contact your practice immediately.
• Sleep apnea devices come with a limited warranty, which may vary depending on the manufacturer.

Insurance and Medical Coding

The following codes apply to the fabrication and adjustment of Herbst and Dorsal devices:

Material Safety Data Sheets (MSDS)

Regulatory and Material Safety

Both Dandy Herbst and Dorsal devices have 510(k) clearance and Class II FDA approval (Premarket Submission Number: K103076). For detailed material information, refer to the Material Safety Data Sheets (MSDS) for Herbst and Dorsal materials.