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ProSomnus® Sleep and Snore DevicesDOCTOR INSTRUCTIONS FOR USE

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TABLE OF CONTENTS

Introduction ..........................................................................................2

Indications ............................................................................................2

Contraindications ..................................................................................2

Warnings ..............................................................................................2

Precautions ...........................................................................................2

Technical Components ......................................................................3-6

Prescribing ProSomnus Sleep Devices ................................................7

Manufacturing Requirements ...............................................................8

Directions for Daily Use ........................................................................8

Homecare Cleaning Instructions ..........................................................8

Advancement Instructions ..............................................................9--12

Storage ...............................................................................................13

Warranty and Repair ...........................................................................13

INTRODUCTION ProSomnus Sleep Devices are intended to reduce snoring and mild to moderate Obstructive Sleep Apnea (OSA) by holding the lower jaw forward during sleep. The ProSomnus device may have a compliance sensor. The compliance sensor logs the time the device is worn.

The dentist prescribes the amount of advancement increments according to the treatment plan. ProSomnus Sleep Devices are single patient use, patient specific, simple to use, comfortable and easy to clean.

INDICATIONS The ProSomnus Sleep and Snore Devices are intended to reduce night time snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults.

CONTRAINDICATIONSThe device is contraindicated for patients who:• Have Central Sleep Apnea.• Have severe respiratory disorders.• Have loose teeth or advance periodontal disease.• Are under 18 years of age.

WARNINGSUse of the device may cause:• Tooth movement or changes in dental occlusion.• Gingival or dental soreness.• Pain or soreness to the temporomandibular joints.• Obstruction of oral breathing.• Excessive salivation.

PRECAUTIONSPatients should consider their medical history, including history of asthma, breathing, or respiratory disorders, or other relevant health problems, and contact the appropriate healthcare provider before using the device.

ProSomnus Sleep and Snore Devices include the ProSomnus® MicrO2®

Sleep and Snore Device, the ProSomnus® [IA] Sleep and Snore Device with Monogram™ Customization Options, the ProSomnus [CA] Sleep and Snore Device and the ProSomnus [PH] Sleep and Snore Device.

These devices will also be referred to as the ProSomnus Sleep Devices.

These FDA cleared devices comply with applicable international medical device regulations.

Caution: Federal (U.S.) law restricts this device to sale by, or on the order of, a dentist’s prescription only.

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Low Profile DesignContoured Cheek and Lip Borders

Retainer-Like Precision Fit

Lingualess Design

Arch Identifier

Dual 90° Non-Radius Posts

TECHNICAL COMPONENTS The ProSomnus Sleep Devices are customized patient specific dental devices. The patient’s device may vary in features selected as part of the Monogram Customization Options available as noted on the ProSomnus Sleep and Snore Devices Rx.

ProSomnus® MicrO2®

The first OAT device designed with patient physiology in mind.

ProSomnus MicrO2 utilizes modern clinical protocols, manufacturing technologies and engineering concepts to resolve the design tradeoffs that limit the performance of traditional OAT devices.

Each ProSomnus Sleep And Snore Device Package Contains:

• 1 or more lower arches• 1 or more upper arches• Instructions for use• Storage case(s)

Additionally, ProSomnus [CA] Sleep and Snore Device packages contain an adjustment key. ProSomnus [PH] Sleep and Snore Device packages contain an adjustment key and/or wrench.

Material content: Polymethylmethacrylate (PMMA).Ball Clasps: Medical grade stainless steel.*

[PH] Herbst Arms & [CA] Jackscrew: Medical grade stainless steel.*

Gold Colored Screw: Titanium nitride coated medical grade stainless steel.**Stainless steel contains nickel and chromium. Meets National Institute for Occupational Safety and Health standards.

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Proprietary Iterative Advancement

• 12.0mm Advancement Range (with UA)• Unlimited Advancement Arches• Titration Intervals• Compliance Sensor Series

Monogram Customization Options

Splint Coverage• Full Lingualess• Full Lingual Coverage• Lingualess Anterior with Full Posterior Coverage• Tapered Posterior

Post Design• Dual 90° Non-Radius Posts• Dual 70° Radius Posts

Other• Anterior Airway• Anterior Discluder• Metal-Free Hooks• And more…

33% Less Vertical Opening Required

BetterPrecision

Precision Driven Symmetrical Design

16% Stronger Anterior/Posterior Direction8% Stronger Lateral Direction

4.5x More Tongue Space

30% Less Overall Volume

Metal-Free3.6x Fewer Monomers

3.0mm LateralFreedom of Movement

ProSomnus® [IA] with Monogram™ Customization Options The only precision Iterative Advancement Medical Device for OAT.

This precision manufactured [IA] Sleep Device is easy to customize for each patient centric treatment plan. Add Anterior Discluders, Airway Openings, Different Dual Post Angles, Splint Coverage Options, Unlimited Advancement Arches and more, all with the intent

of optimizing treatment outcomes, patient experiences and clinical efficiency. Personalize and customize with the ProSomnus [IA] Device and Monogram Customization Options.

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ProSomnus® [IA] SELECT Designed to be the most comfortable Medical Device for OSA.

A signature variation of the ProSomnus [IA] Device, SELECT enables patients to have an excellent treatment experience. SELECT is optimized for patients with challenged lip competency with less than 5.0mm of anticipated advancement.

ProSomnus® [PH] The only precision Herbst-style Medical Device for OAT.

The ProSomnus [PH] Precision Herbst-style Sleep Device is FDA cleared, Medicare E0486 verified and designed to provide a better experience for all patients. Incorporating the ProSomnus precision OAT platform, ProSomnus [PH] offers all the benefits

Nested Dual Posts Minimal Facial Coverage

Anatomical Splint

Upper Posterior Comfort Bumps

Metal-Free Hooks for Elastics

Retainer Like, Precision Fit5.7x More Tongue Space

Upper Gold Screw for Arch Indicator

Upper Blue Arrow for Arch Indicator

7.0mm Range

Wrench-style Hex Nut Titration

Lower Anterior Comfort Bumps

Capped Screws for Comfort

E0486 VERIFIED

of ProSomnus [IA] and [CA], using a Herbst-style advancement mechanism providing 7.0mm total titration. ProSomnus [PH] provides greater comfort, durability, smaller overall volume, ease of use and efficiency over predicate Herbst-style devices.

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ProSomnus® [CA] LP The only low-profile Continuous Advancement OAT Medical Device for OSA.

ProSomnus [CA] LP is the only low-profile Continuous Advancement OAT Medical Device for OSA. In addition to the ProSomnus platform advantages such as fewer side effects, biocompatible hygienic mate-rial, impression-free digital replacements and device customizations, [CA] LP uniquely offers clinicians precision Continuous Advancement

without compromising patient comfort. ProSomnus [CA] LP utilizes proprietary technologies to resolve the archform asymmetries, man-ufacturing variances, bulkiness and other device design limitations of traditional dorsal style Continuous Advancement devices.

34% Overall Lower Profile

More Flex forEasy Delivery

Low Profile Advancement System

3.0mm Lateral Freedom of Movement

12.0mm Advancement Range (with UA)

38% Less Bulk for Lip Closure

Natural Anatomical Scalloping

Prescription DrivenSymmetrical Design

Engineered for Comfort

29% Less Bulk for Buccal Comfort

Optimized for Greater Tongue Space

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PRESCRIBING THE MICRO2 AND [IA] SLEEP AND SNORE DEVICES

PRESCRIBING THE [PH] SLEEP AND SNORE DEVICE

PRESCRIBING THE PROSOMNUS [CA] SLEEP AND SNORE DEVICES

ProSomnus MicrO2 and [IA] Sleep and Snore Devices follow an Iterative Advancement protocol, including four initial arches:

• Series A includes 1 set of upper and lower initial arches milled at the bite registration position. Initial arches are identified as being in the zero (0) position. • Series A includes two more advancement arches. The additional upper advancement arch is milled at 2.0mm. The additional lower advancement arch is milled at 1.0mm. Advancements are measured and milled from the zero (0) position.

The ProSomnus [PH] Sleep and Snore Device uses a Continuous Advancement protocol.

The upper arch is connected by a Herbst Arm to the lower arch with a Herbst Nut Plus Wrench Adjustment or Herbst Pinhole Adjustment allowing for small incremental adjustments in a range from -1.0mm to 6.0mm. The ProSomnus [PH] Sleep and Snore Device provides contin-uous advancement titration capacity and is Medicare E0486 verified.

Jaw advancements are achieved by adjusting the Herbst nuts or pin-holes by using the tool provided, per your prescription. Advancements up to 12.0mm may be achieved with additional arches as prescribed.

The ProSomnus [CA] Sleep and Snore Devices also use a Continuous Advancement protocol. There are two types of ProSomnus [CA] Sleep and Snore Devices:

ProSomnus [CA] The ProSomnus [CA] Sleep and Snore Device provides 1 upper [CA] arch with Continuous Advancement titration capability and 1 lower arch (L0). The upper [CA] arch has a split 90° Post that contains an adjust-able expansion screw allowing for small incremental adjustments in a range from -1.0mm to 5.0mm. When the advancement is completed using that upper advancement range and you find your patient will need more advancement, simply order an additional lower advancement arch (L5), which adds another 5.0mm or total advancement up to 12.0mm.

ProSomnus [CA] LPThe ProSomnus [CA] LP, a Continuous Advancement Low-Profile option which includes: 1 upper [CA] LP arch; 1 lower (L0) arch; 1 lower (L3) arch; Lingualess Anterior Coverage; Full Posterior Coverage; Tapered Posts; Flat Plane Splint Design with Lingual and Labial Anatomical Scalloping. Device starting position is set at bite when delivered. When the advancement is completed using the initial upper [CA] LP arch, the patient can swap in the lower (L3) arch.

Note: Both the ProSomnus [CA] and [CA] LP Sleep and Snore Devices can be adjusted within a 12.0mm total titration range.

Jaw advancements are achieved by removing the current upper or lower arch and inserting the next prescribed arch in the series. Advancements up to 12.0mm may be achieved with additional arches as prescribed.

Note: ProSomnus [IA] comes with [UA] Unlimited Advancement Arches. When the advancement is completed using the initial series and you find that the patient will need another arch at 1.0mm or 0.5mm position that differs from the initial series, simply order the next desired advancement arch. If you find that the patient needs another advance-ment arch still, again order another 1.0mm or 0.5mm position that differs from the previous series and additional arch(es). Repeat until satisfied that your patient is in the treatment position you desired.

4 DEVICES U0, U2, L0, L1 COMBINATION ADVANCEMENTS

Upper 0 + Lower 0 0mm

Upper 0 + Lower 1 1.0mm

Upper 2 + Lower 0 2.0mm

Upper 2 + Lower 1 3.0mm

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DIRECTIONS FOR DAILY USE OF THE PROSOMNUS SLEEP DEVICES1. Insert prior to sleep.2. Inspect the device prior to use. Contact prescriber if any abnormalities are observed.3. Rinse with water before use.4. Select the prescribed arches, sandwich together.5. Open wide, secure the arches onto your teeth.6. Gently relax the jaw and settle down for a restful night.7. To remove the device: a. First remove the lower arch. Gently open the mouth and place your thumbs into the cheek areas below the post on both side edges of the device to lift out and remove. b. Apply even, upward pressure at the side edges of the device to lift out and remove. c. Repeat the same process for the upper arch by applying downward pressure, using index fingers.

Note: Do not remove one-handed, this will place unnecessary torque on the arch frame and can cause breakage.

WARNING: Always wear both upper and lower arches together. Never wear individual arches only.

HOMECARE INSTRUCTIONSNote: Sterilization is not required.Daily:• After use, thoroughly clean the ProSomnus Sleep Device using a regular soft toothbrush, cool or warm water and mild detergent, such as orthodontic device cleansers or antibacterial liquid soaps.• Rinse thoroughly and dry the appliance completely. Store in the container. Leave the container open to ensure that the devices dry.• Daily soaking of the devices is not recommended.Note: Mouthwash, bleach solutions, denture cleaners or abrasive toothpaste may harm the device.

MANUFACTURING REQUIREMENTS

Repositioning Bite Registration • A repositioning open bite at a protrusive position. • Bite registration material must extend to cover the full length of the arch. • Needs to represent the correct midline position, as determined by the prescribing dentist.

ProSomnus devices require 3.0mm of clearance at the lowest cusp point. The diagram below shows how to visualize the amount of space required.

Doctors have been reported using several additional techniques when issues arise to make sure they have enough clearance:• Moving the bite fork to include dangling cusps.• Modifying the bite fork to capture dangling cusps.• Adding material to the incisal guide area to open the vertical more.• Measuring with a caliper in the bicuspid and molar areas.• Shortening the device when there is an excessive Curve of Spee.

ProSomnus Sleep Device Prescription • Please identify the advancement iterations you require. • Please sign your prescription and include all necessary highlighted information.

Accurate U/L Full Arch Models or Impressions • Must capture distal surfaces of terminal molars. • Recommend PVS impression material. • Digital Impression Policy: ProSomnus receives digital impressions. For quality assurance purposes, sleep devices made from digital impressions are fit against a 3D printed model of the digital impres- sion. Device is designed to fit stone models from impressions, always test fit on models.

3.0mm 3.0mm3.0mm3.0mm

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ADVANCEMENT INSTRUCTIONS

ProSomnus MicrO2 and [IA] Sleep and Snore Devices:

ProSomnus [CA] Sleep and Snore Devices:

ProSomnus [CA] Backward Adjustment:

1. 3.2. 4.

IMPORTANT!

Hold upper tray with expansion screw facing you.

Rotate the expansion tool 90° in the direction opposite of the arrow.

Fit the expansion tool into the adjustment keyhole.

Count your turns and repeat adjustments on both sides.

1.

ProSomnus [CA] Forward Adjustment:

3.2. 4.

IMPORTANT!

Hold upper tray with expansion screw facing you. Locate yellow reference arrow on device.

Rotate the expansion tool 90° in the direction of the arrow to advance forward.

Fit the expansion tool into the adjustment keyhole.

Count your turns and repeat adjustments on both sides.

Jaw advancements are achieved by removing the current upper or lower arch and inserting the next prescribed arch in the series. Advancements up to 12.0mm may be achieved with additional arches as prescribed by the doctor.

Jaw advancements are achieved by adjusting the expansion screw, using the tool provided, per the prescription. Note: The arrows on the side of the expansion screw. These indicate the direction to turn the screw to advance the post. Each 90° turn is 0.1mm.

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ProSomnus [CA] Advancement Tables:

ProSomnus [CA] Standard, (Upper [CA] Arch + Lower 0 Arch):

ProSomnus [CA] with Additional Lower Advancement Arch, (Upper [CA] Arch + Lower +5.0mm Arch):

Note: The ProSomnus [CA] Sleep and Snore Device can be adjusted within a 12.0mm total titration range. You will instruct your patient on the number of 90° screw turns to make based on comfort and symptom reduction. You may provide the patient with an additional lower arch to achieve additional advancement. Resetting Upper Post: Turn screw on Upper [CA] Arch 90° in the opposite direction to move post to the back of the arch.

+5.0mmStarting Position

Reverse (90 o Screw

Turns)

Bite Starting Position

Forward (90 o Screw Turns)

90o Screw Turns -10 -5 0 5 10 15 20 25 30 35 40 45 50

Expansion Screw Adj. (mm)

-1.0 mm

-0.5 mm

0.0 mm

0.5 mm

1.0 mm

1.5 mm

2.0mm

2.5 mm

3.0 mm

3.5 mm

4.0 mm

4.5 mm

5.0 mm

Expansion screw reset position Forward (90 o Screw Turns)

90o Screw Turns 0 5 10 15 20 25 30 35 40 45 50 55 60

Expansion Screw Adj. (mm)

5.0 mm

5.5 mm

6.0 mm

6.5 mm

7.0 mm

7.5 mm

8.0 mm

8.5 mm

9.0 mm

9.5 mm

10.0 mm

10.5 mm

11.0 mm

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ProSomnus [CA] LP Advancement Tables:

Note: The ProSomnus [CA] LP Sleep and Snore Device can be adjusted within a 12.0mm total titration range. You will instruct your patient on the number of 90° screw turns to make based on comfort and symptom reduction. You may provide your patient with an additional lower arch to achieve additional advancement. Resetting Upper Post: Turn screw on Upper [CA] LP Arch 90° in the opposite direction to move post to the back of the arch.+3.0mmStarting Position

Starting Position Forward Advancement

Screw Turns (Forward 90°)

0 5 10 15 20 25 30 34

Bite Position (mm) 0.0 mm

0.4 mm

0.9 mm

1.3 mm

1.8 mm

2.2 mm

2.6 mm

3.0 mm

Starting Position Forward Advancement

Screw Turns (Forward 90°)

0 5 10 15 20 25 30 34

Bite Position (mm) 3.0 mm

3.4 mm

3.9 mm

4.3 mm

4.8 mm

5.2 mm

5.6 mm

6.0 mm

ProSomnus [CA] LP, (Upper LP [CA] Arch + Lower 0 Arch):

ProSomnus [CA] LP with Additional Lower Advancement Arch, (Upper [CA] LP Arch + Lower +3.0mm Arch):

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ProSomnus [PH] Sleep and Snore Devices:• Jaw advancements are achieved by adjusting the Herbst nuts or pinholes by using the tool provided, per your prescription. Advancements up to 12.0mm may be achieved with additional arches as prescribed by you. Pay attention to the arrows on the side of the Herbst arm. These arrows indicate the direction to turn the screw to advance. Each 90° turn is 0.1mm and each full turn is 0.4mm.

1) Hold the upper arch perpendicular to the lower arch, such that the Herbst arm is straight up and down:

2) To advance each side by 0.1mm, position the adjustment tool straight forward as shown in Fig 1a.

3) Rotate 90° in the direction of the arrow on the Herbst arm as shown in Fig 1b. Repeat on the other side.

4) To reduce advancement, rotate in the opposite direction of the arrow shown in Fig 1b. Repeat on the other side.

5) Confirm adjustment position of the Herbst arm by holding the wrench next to the Herbst arm as shown in Fig 2.

Reverse (90o Turns)

Bite Starting Position Forward (90 o Turns)

90° Turns -10 -5 0 5 10 15 20 25 30 35 40 45 50 55 60

Herbst Arm Adj.

(mm)

-1.0 mm

-0.5 mm

0.0 mm

0.5 mm

1.0 mm

1.5 mm

2.0 mm

2.5 mm

3.0 mm

3.5 mm

4.0 mm

4.5 mm

5.0 mm

5.5 mm

6.0 mm

Fig 2

1 3 5 7

L L

0mmAdvancement Markings (Raised lines on device provide referece of advancement location)

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ProSomnus [PH] Adjustment Table:

Fig 1a

Fig 1b

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STORAGEKeep out of reach of small children and pets.

The ProSomnus Sleep Device should be stored in a cool, dry place. Ensure the device is not exposed to extreme temperature in excess of 60°C/140°F.

WARRANTY AND REPAIR Terms and Conditions

ProSomnus Sleep Devices carry a service warranty of 3 years* from date of manufacture for a one-time repair, reline, or replacement per arch. Non-standard designs are not warranted. Upon repair or reline, the service warranty is retired. Upon one-time replacement, the remainder of the original warranty period, from original date of manufacture, remains intact.

ProSomnus [PH] Herbst-style Sleep Devices

After structural review of the case, all Herbst-style parts should be replaced by the prescribing dentist. ProSomnus offers a ProKit for purchase which includes all Herbst-style replacement parts. Please return any defective parts to ProSomnus for investigation.

*ProSomnus [PH] carries a best in class service warranty of 3 + 2 years for Medicare patients. Please contact ProSomnus to arrange verification of patient’s Medicare coverage.

Visit ProSomnus.com (Terms and Conditions Section) for further information.

Visit ProSomnus.com (Education Section) for a series of technique videos.

PATENTED MD 1

PATENTED MD 1

Consult instructions for use

Manufacturer

Non-sterile

Keep dry

Upper limit of temperature

Caution

Prescription only

European conformity

Medical Device

Single Patient – multiple use

Authorized representative in the European Community

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PATENTED

ProSomnus® and MicrO2® are Registered Trademarks. ProSomnus, MicrO2 the “O” logo design and the

artwork and designs contained herein are trademarks and copyrights of ProSomnus Sleep Technologies, Inc. and may not be reproduced, distributed, displayed, published, altered or used without prior written consent. All other products and company names mentioned herein are trademarks of their respective

owners, and ProSomnus Sleep Technologies, Inc. is not associated, affiliated, endorsed, or sponsored by Herbst and/or the current owner of the Herbst name.

U.S. Patent No. 9,820,882 | U.S. Patent No. 9,808,327PRO3-061-D (April 2020)

ProSommus Sleep Technologies5860 West Las Positas Blvd., Suite 25

Pleasanton, CA 94588, USA

Main 844.537.5337 | ProSomnus.comLeader in Precision OAT®