Patient IFU - Serena SleepSerena Sleep

Portal Dental professional

[email protected]

Congratulations for taking this step in relieving sleep apnea using a comfortable and effective sleep appliance by Serena Sleep.

Your healthcare professional is dedicated to help you improve your obstructive sleep apnea.

Appliance Description

Your new Serena Sleep appliance is custom- made to your teeth. It is an intraoral appliance used for treating snoring and sleep apnea. This oral appliance is designed to advance your lower jaw (mandibular) to help open your upper air way while you sleep. Please see your speciﬁc model description for further detailed information.

Rx only. Federal law restricts this appliance to sale by prescription.

How To Use Elevate Model	How to use Serena Nylon EMA® Model	Jaw Positioning, Removingthe Appliance
Period of Use, Morning Activities	Morning Repositioner	Cleaning and Storage, Deep Cleaning
Appliance Selection, Sleep Study	Appliance Exam & Prescribing

How To Use Elevate Model

Remove the Serena Sleep appliances from the package and examine them.
Working with your dental healthcare professional, select the proper upper and lower appliances as indicated by the letter code on the side of the appliances. Codes A, B and C are designed for your upper teeth and Codes X, Y and Z are designed for your lower teeth. You may have one, two or three upper appliances and one, two or three lower appliances.
- Use the upper and lower appliances as instructed by your dental healthcare professional.
  1. Upper and lower appliances have step placements for different advancements to optimize the effectiveness and comfort of your Serena Sleep Appliance.
  2. Each upper and lower appliance has notches for elastics to help train your teeth to stay together through the night. Use these elastics as instructed by your dental healthcare professional.
  3. When using elastics, make sure both sides of your appliances are using matching elastics.
  4. It can take several weeks of use to achieve optimal efficiency and comfort.
Rinse the appliance thoroughly. Clean with antibacterial soap and a toothbrush.
Prior to sleeping, insert the appliance in your mouth. The appliance should remain on your teeth for the entire sleep period.

Inserting the Elevate appliance when not using elastics:

Place the upper appliance in your mouth. Press up on the appliance with both thumbs to ensure that it ﬁts securely and comfortably. Place the lower appliance in your mouth. Press down on both sides of the appliance using your index ﬁngers to ensure it ﬁts comfortably.

Inserting the Elevate appliance when using elastics:

Place upper and lower appliances in your mouth and press up on the appliance with both thumbs to ensure that the upper appliance ﬁts securely and comfortably on your upper teeth. Position the lower appliance so that it is aligned with your teeth and press down on the appliance to ensure that the lower appliance ﬁts securely and comfortably on your lower teeth.

How to use Serena Nylon EMA® Model

Remove the Serena Sleep appliances from the package and examine them.
Working with your dental healthcare professional, place the proper advancement bands on the posts as shown here.
- Advancement Bands:
  1. Use the bands as instructed by your dental healthcare professional.
  2. Bands have different lengths and elasticity to optimize the effectiveness and comfort of your Serena Sleep appliance.
  3. Make sure both sides of your appliances are using matching bands.
  4. It can take several weeks of use to achieve optimal effectiveness and comfort.
Rinse the appliance thoroughly with warm water and clean with a toothbrush and antibacterial soap
Prior to sleeping, insert the appliance in your mouth. The appliance should remain in for the entire sleep period.

Place upper and lower appliances in mouth and press up on the appliance with both thumbs to ensure that upper appliances fit securely and comfortably on to your upper teeth.

Position the lower appliance so that it is aligned with your teeth and press down on the appliance to ensure the lower appliance fits securely and comfortable on your lower teeth.

Jaw Positioning

With the upper and lower appliance ﬁtted on your teeth, gently bite down and slide your bottom jaw forward and then relax your jaw and your bite. Note: Always wear the upper appliance and lower appliance when using. Do not wear only one without wearing the other.

Removing the Appliance

Using your thumbs on both sides, gently pull the lower appliance in an upwards motion to remove. Using both your index ﬁngers and thumbs, gently pull the upper appliance down and forwards to remove.

Period of Use

The appliance can be worn every night.
The appliance should be replaced when the appliance cracks or the appliance fails to stay in the patient’s mouth. If one of these problems occur please return the appliance to your doctor/ dentist for evaluation and potential replacement.

Morning Activities

The American Academy of Dental Sleep Medicine suggests jaw exercises may reduce jaw discomfort related to using your oral sleep apnea appliance. The American Academy of Dental Sleep Medicine has a 4-minute video that shows several jaw exercises. Type in this information to go to the video: https://www.aadsm.org/patient_jaw_exercises.php

Morning Repositioner

If your dental healthcare professional provided you with a morning repositioner, it is important to use it each morning as instructed by your dental healthcare professional.

Sore jaw muscles are common when ﬁrst using your sleep appliance. If jaw pain or bite problems persist, contact your dental healthcare professional.

Cleaning and Storage

It is very important to clean your Serena Sleep appliance daily to ensure you get the best benefit and longevity from the appliance. Please follow the steps below to clean your appliance.

Always clean your appliance in the morning immediately after having removed it from your mouth.
Use a soft toothbrush.
Do not use toothpaste as it contains abrasives.
After having removed the appliance from the storage case, thoroughly brush it with a toothbrush and antibacterial soft soap and rinse.
Dry all parts of the appliance and storage case carefully and thoroughly using a clean towel.
When not in use, the appliance should be stored in your storage case and kept away from children, pets and out of direct sunlight.

Recommended Deep Cleaning

Deep clean your Serena Sleep appliance twice a week. Fill your provided container about ½ full with warm water. Add a compatible cleanser (your appliance is made from Nylon 12 material) and then place your appliances into the container. Submerse your appliances according to the cleanser instructions.

After the cleaning process is complete, rinse your appliance and dry it. Discard the used cleaning solution and rinse and dry your container.

Note that some cleansers contain allergen ingredients. Be sure to follow the cleaner’s instructions and warnings.

Appliance Selection, Sleep Study, Appliance Exam & Prescribing

It is imperative that you have a sleep study completed prior to receiving a prescription for an intraoral appliance. The sleep study will determine the level or severity that you are currently experiencing, and this information should be used by your dentist to determine your prescription. You should receive a complete and comprehensive dental exam prior to receiving a snoring or sleep apnea appliance. Once you have undergone a comprehensive dental exam complete with full records and a sleep study then the dentist can accurately prescribe a snoring or sleep apnea appliance.

Warranty

Serena Sleep warrants this appliance be free from defects in materials and in fabrication for a period of 36 months from the date of delivery to the providing practitioner. This appliance is meant for treating snoring and obstructive sleep apnea at the source. Serena Sleep does not make any guarantees regarding the outcome treatment of obstructive sleep apnea.

Serena Sleep warranty is invalidated if the appliance needs to be remade due to change in the patient’s oral anatomy.

The longevity of the appliance is left up to the patient once received from the providing dentist. The warranty is invalidated if the patient breaks a particular area on the appliance that cannot be repaired and therefore the appliance needs to be remade.

Warranty does not cover accessory parts (straps, hinges, elastics, etc.) bite registration change, improper cleaning, unauthorized modiﬁcations or any other non-manufacturing related issues.

Manufactured by Serena Sleep

Registered trademarks

US Patent No: 9655695

US Patent No: 9744006

US Patent No: D870894S

US Patent No: 11185436

Made in the USA – FDA Cleared

Appliance Description

The Serena Sleep Nightguard/Occlusal Appliance are custom-made intraoral orthotic used for protecting teeth and restorations against the forces of bruxism and alleviating temporomandibular joint, jaw, and muscle and tension headache pain. These appliances are made of durable, medical grade, Nylon PA2200 (polyamide 12) unless otherwise noted.

Rx only. Federal law restricts this device to be sold only by or on the order of a prescription.

How to Use Your NIGHTGUARD and OCCLUSAL Appliance

Remove the Serena Sleep Nightguard/Occlusal Appliance from the package and examine them.

Working with your dental healthcare professional, determine if the appliance is fitted for your upper or lower teeth. If both are included, determine which appliance is for your upper teeth and which is for your lower teeth. Wear your appliance(s) as instructed by your dental healthcare professional.

Inserting your Appliance(s)

If an upper appliance is used, insert it into the mouth and press up on the appliance with both thumbs to ensure that it fits securely and comfortably. If a lower appliance is used, place it in the mouth and press down on both sides of the appliance using index fingers to ensure it fits comfortably.

Patient should gently bite down on the appliances to ensure they are seated and comfortable on the teeth.

Removing the Appliance

To remove the appliance(s), use thumb or fingernail on the edge of the appliance near the back of the mouth and push away from the teeth then peel the appliance from the rest of the teeth.

Period of Use

From the time you receive the appliance, you should wear it as instructed by your dental healthcare professional. You should not wear the appliance if you have not worn the device within the first year after receiving the appliance. See your dental healthcare professional for instructions. The appliance should be replaced when the appliance cracks or the device fails to stay in the patient’s mouth. The appliance should be replaced wheninstructed by your dental healthcare professional or the appliance cracks or the appliance fails to stay in the patient’s mouth.

If you have questions or concerns, please contact your dental healthcare professionals.

Cleaning and Storage

It is very important to clean your Serena Sleep appliance daily to ensure you get the best benefit and longevity from the appliance. Please follow the steps below to clean your appliance.

Always clean your appliance in the morning immediately after having removed it from your mouth.
Use a soft toothbrush.
Do not use toothpaste as it contains abrasives.
After having removed the appliance from the storage case, thoroughly brush it with a toothbrush and antibacterial soft soap and rinse.
Dry all parts of the appliance and storage case carefully and thoroughly using a clean towel.
When not in use, the appliance should be stored in your storage case and kept away from children, pets and out of direct sunlight.

Recommended Deep Cleaning

After the cleaning process is complete, rinse your appliance and dry it. Discard the used cleaning solution and rinse and dry your container. Note that some cleansers contain allergen ingredients. Be sure to follow the cleaner’s instructions and warnings.

Warranty

Serena Sleep warrants this appliance to be free from defects in materials and in fabrication for a period of 12 months from the date of delivery to the providing practitioner. This device is used for protecting teeth and restorations against the forces of bruxism and alleviating temporomandibular joint, jaw, and muscle and tension headache pains source. Serena Sleep does not make any guarantees regarding the outcome of the treatment.

Serena Sleep warranty is invalidated if the appliance needs to be remade due to change in the patient’s oral anatomy. The warranty is invalidated if the patient breaks, cracks or wears through any area on the appliance.

Warranty does not cover improper cleaning, unauthorized modiﬁcations or any other non-manufacturing related issues or any accessory parts.