ProSomnus Sleep and Snore Devices - DOCTOR INSTRUCTIONS FOR USE
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ProSomnus® Sleep and Snore Devices
DOCTOR INSTRUCTIONS FOR USE
1
TABLE OF CONTENTS INTRODUCTION
ProSomnus Sleep Devices are intended to reduce snoring and mild to
Introduction........................................................................................... 2
moderate Obstructive Sleep Apnea (OSA) by holding the lower jaw
forward during sleep. The ProSomnus device may have a compliance
Indications............................................................................................. 2 sensor. The compliance sensor logs the time the device is worn.
Contraindications................................................................................... 2 The dentist prescribes the amount of advancement increments
according to the treatment plan. ProSomnus Sleep Devices are single
Warnings............................................................................................... 2 patient use, patient specific, simple to use, comfortable and easy to
clean.
Precautions............................................................................................ 2
Technical Components....................................................................... 3-6
INDICATIONS
The ProSomnus Sleep and Snore Devices are intended to reduce
night time snoring and mild to moderate Obstructive Sleep Apnea
Prescribing ProSomnus Sleep Devices................................................. 7 (OSA) in adults.
Manufacturing Requirements................................................................ 8
CONTRAINDICATIONS
Directions for Daily Use......................................................................... 8 The device is contraindicated for patients who:
• Have Central Sleep Apnea.
Homecare Cleaning Instructions........................................................... 8 • Have severe respiratory disorders.
• Have loose teeth or advance periodontal disease.
• Are under 18 years of age.
Advancement Instructions............................................................... 9--12
Storage................................................................................................ 13 WARNINGS
Use of the device may cause:
Warranty and Repair............................................................................ 13 • Tooth movement or changes in dental occlusion.
• Gingival or dental soreness.
ProSomnus Sleep and Snore Devices include the ProSomnus® MicrO2® • Pain or soreness to the temporomandibular joints.
Sleep and Snore Device, the ProSomnus® [IA] Sleep and Snore Device • Obstruction of oral breathing.
with Monogram™ Customization Options, the ProSomnus [CA] Sleep • Excessive salivation.
and Snore Device and the ProSomnus [PH] Sleep and Snore Device.
These devices will also be referred to as the ProSomnus Sleep Devices. PRECAUTIONS
These FDA cleared devices comply with applicable international Patients should consider their medical history, including history of
asthma, breathing, or respiratory disorders, or other relevant health
medical device regulations.
problems, and contact the appropriate healthcare provider before
Caution: Federal (U.S.) law restricts this device to sale by, or on the using the device.
order of, a dentist’s prescription only.
2
Each ProSomnus Sleep And Snore Device Package Contains:
• 1 or more lower arches
• 1 or more upper arches Material content: Polymethylmethacrylate (PMMA).
• Instructions for use Ball Clasps: Medical grade stainless steel.*
• Storage case(s) [PH] Herbst Arms & [CA] Jackscrew: Medical grade stainless steel.*
Gold Colored Screw: Titanium nitride coated medical grade stainless
Additionally, ProSomnus [CA] Sleep and Snore Device packages steel.*
contain an adjustment key. ProSomnus [PH] Sleep and Snore Device *Stainless steel contains nickel and chromium. Meets National
packages contain an adjustment key and/or wrench. Institute for Occupational Safety and Health standards.
TECHNICAL COMPONENTS Retainer-Like
Precision Fit
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. Contoured Cheek
Low Profile Design and Lip Borders
ProSomnus MicrO2 utilizes modern clinical protocols, manufacturing
technologies and engineering concepts to resolve the design
tradeoffs that limit the performance of traditional OAT devices. Dual 90° Non-Radius Posts Lingualess Design
Arch Identifier
3
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 of optimizing treatment outcomes, patient experiences and clinical
for each patient centric treatment plan. Add Anterior Discluders, efficiency. Personalize and customize with the ProSomnus [IA]
Airway Openings, Different Dual Post Angles, Splint Coverage Device and Monogram Customization Options.
Options, Unlimited Advancement Arches and more, all with the intent
30% Less 4.5x More Proprietary Iterative Advancement
Overall Volume Tongue Space • 12.0mm Advancement Range (with UA)
• Unlimited Advancement Arches
• Titration Intervals
• Compliance Sensor Series
3.0mm Lateral
Freedom of Movement Monogram Customization
Options
Splint Coverage
• Full Lingualess
• Full Lingual Coverage
• Lingualess Anterior with Full
Posterior Coverage
Metal-Free • Tapered Posterior
3.6x Fewer Monomers
Post Design
• Dual 90° Non-Radius Posts
16% Stronger Anterior/
• Dual 70° Radius Posts
Posterior Direction
8% Stronger Lateral Direction Other
• Anterior Airway
• Anterior Discluder
Precision Driven 33% Less Vertical Better • Metal-Free Hooks
Symmetrical Design Opening Required Precision • And more…
4
ProSomnus® [IA] SELECT Nested Dual Posts Minimal Facial
Coverage
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.
Anatomical Splint
ProSomnus® [PH]
The only precision Herbst-style Medical Device for OAT.
The ProSomnus [PH] Precision Herbst-style Sleep Device is FDA of ProSomnus [IA] and [CA], using a Herbst-style advancement
cleared, Medicare E0486 verified and designed to provide a better mechanism providing 7.0mm total titration. ProSomnus [PH] provides
experience for all patients. Incorporating the ProSomnus greater comfort, durability, smaller overall volume, ease of use and
precision OAT platform, ProSomnus [PH] offers all the benefits efficiency over predicate Herbst-style devices.
Upper Upper Blue 5.7x More Retainer Like, Precision Fit
Posterior Arrow for Arch Tongue Space
Comfort Indicator Metal-Free Hooks
Bumps for Elastics
E0486 VERIFIED
Upper Gold Screw for
Arch Indicator
7.0mm Wrench-style Capped Screws Lower Anterior
Range Hex Nut Titration for Comfort Comfort Bumps
5
ProSomnus® [CA] LP
The only low-profile Continuous Advancement OAT Medical Device
for OSA.
ProSomnus [CA] LP is the only low-profile Continuous Advancement without compromising patient comfort. ProSomnus [CA] LP utilizes
OAT Medical Device for OSA. In addition to the ProSomnus platform proprietary technologies to resolve the archform asymmetries, man-
advantages such as fewer side effects, biocompatible hygienic mate- ufacturing variances, bulkiness and other device design limitations of
rial, impression-free digital replacements and device customizations, traditional dorsal style Continuous Advancement devices.
[CA] LP uniquely offers clinicians precision Continuous Advancement
12.0mm Advancement 34% Overall More Flex for 38% Less Natural
Range (with UA) Lower Profile Easy Delivery Bulk for Lip Anatomical
Closure Scalloping
3.0mm Lateral
Freedom of
Movement
Engineered for
Comfort Optimized
for Greater
Low Profile Prescription Driven 29% Less Bulk for Tongue
Advancement System Symmetrical Design Buccal Comfort Space
6
PRESCRIBING THE MICRO2 AND [IA] PRESCRIBING THE [PH] SLEEP AND
SLEEP AND SNORE DEVICES SNORE DEVICE
ProSomnus MicrO2 and [IA] Sleep and Snore Devices follow an The ProSomnus [PH] Sleep and Snore Device uses a Continuous
Iterative Advancement protocol, including four initial arches: Advancement protocol.
• Series A includes 1 set of upper and lower initial arches milled at the The upper arch is connected by a Herbst Arm to the lower arch with
bite registration position. Initial arches are identified as being in the a Herbst Nut Plus Wrench Adjustment or Herbst Pinhole Adjustment
zero (0) position. allowing for small incremental adjustments in a range from -1.0mm to
• Series A includes two more advancement arches. The additional 6.0mm. The ProSomnus [PH] Sleep and Snore Device provides contin-
upper advancement arch is milled at 2.0mm. The additional lower uous advancement titration capacity and is Medicare E0486 verified.
advancement arch is milled at 1.0mm. Advancements are measured
Jaw advancements are achieved by adjusting the Herbst nuts or pin-
and milled from the zero (0) position.
holes by using the tool provided, per your prescription. Advancements
up to 12.0mm may be achieved with additional arches as prescribed.
4 DEVICES COMBINATION ADVANCEMENTS
U0, U2, L0, L1
Upper 0 + PRESCRIBING THE PROSOMNUS [CA]
0mm
Lower 0
SLEEP AND SNORE DEVICES
Upper 0 +
1.0mm The ProSomnus [CA] Sleep and Snore Devices also use a Continuous
Lower 1
Advancement protocol. There are two types of ProSomnus [CA] Sleep
Upper 2 + and Snore Devices:
2.0mm
Lower 0 ProSomnus [CA]
The ProSomnus [CA] Sleep and Snore Device provides 1 upper [CA]
Upper 2 +
3.0mm arch with Continuous Advancement titration capability and 1 lower arch
Lower 1
(L0). The upper [CA] arch has a split 90° Post that contains an adjust-
able expansion screw allowing for small incremental adjustments in a
Jaw advancements are achieved by removing the current upper or
range from -1.0mm to 5.0mm. When the advancement is completed
lower arch and inserting the next prescribed arch in the series.
using that upper advancement range and you find your patient will need
Advancements up to 12.0mm may be achieved with additional arches
more advancement, simply order an additional lower advancement arch
as prescribed.
(L5), which adds another 5.0mm or total advancement up to 12.0mm.
Note: ProSomnus [IA] comes with [UA] Unlimited Advancement ProSomnus [CA] LP
Arches. When the advancement is completed using the initial series The ProSomnus [CA] LP, a Continuous Advancement Low-Profile
and you find that the patient will need another arch at 1.0mm or 0.5mm option which includes: 1 upper [CA] LP arch; 1 lower (L0) arch; 1 lower
position that differs from the initial series, simply order the next desired (L3) arch; Lingualess Anterior Coverage; Full Posterior Coverage;
advancement arch. If you find that the patient needs another advance- Tapered Posts; Flat Plane Splint Design with Lingual and Labial
ment arch still, again order another 1.0mm or 0.5mm position that Anatomical Scalloping. Device starting position is set at bite when
differs from the previous series and additional arch(es). Repeat until delivered. When the advancement is completed using the initial upper
satisfied that your patient is in the treatment position you desired. [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.
7
MANUFACTURING REQUIREMENTS DIRECTIONS FOR DAILY USE OF THE
Repositioning Bite Registration PROSOMNUS SLEEP DEVICES
• A repositioning open bite at a protrusive position. 1. Insert prior to sleep.
• Bite registration material must extend to cover the full length 2. Inspect the device prior to use. Contact prescriber if any
of the arch. abnormalities are observed.
• Needs to represent the correct midline position, as determined by the 3. Rinse with water before use.
prescribing dentist. 4. Select the prescribed arches, sandwich together.
5. Open wide, secure the arches onto your teeth.
ProSomnus devices require 3.0mm of clearance at the lowest cusp 6. Gently relax the jaw and settle down for a restful night.
point. The diagram below shows how to visualize the amount of space 7. To remove the device:
required. 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
3.0mm 3.0mm 3.0mm 3.0mm
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.
Doctors have been reported using several additional techniques when
issues arise to make sure they have enough clearance:
WARNING: Always wear both upper and lower arches together.
• Moving the bite fork to include dangling cusps.
Never wear individual arches only.
• 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. HOMECARE INSTRUCTIONS
ProSomnus Sleep Device Prescription Note: Sterilization is not required.
Daily:
• Please identify the advancement iterations you require.
• After use, thoroughly clean the ProSomnus Sleep Device using
• Please sign your prescription and include all necessary highlighted
a regular soft toothbrush, cool or warm water and mild detergent,
information.
such as orthodontic device cleansers or antibacterial liquid soaps.
• Rinse thoroughly and dry the appliance completely. Store in the
Accurate U/L Full Arch Models or Impressions
container. Leave the container open to ensure that the devices dry.
• Must capture distal surfaces of terminal molars. • Daily soaking of the devices is not recommended.
• Recommend PVS impression material. Note: Mouthwash, bleach solutions, denture cleaners or abrasive
• Digital Impression Policy: ProSomnus receives digital impressions. toothpaste may harm the device.
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.
8ADVANCEMENT INSTRUCTIONS
ProSomnus MicrO2 and [IA] Sleep and Jaw advancements are achieved by removing the current upper
or lower arch and inserting the next prescribed arch in the series.
Snore Devices: Advancements up to 12.0mm may be achieved with additional
arches as prescribed by the doctor.
ProSomnus [CA] Sleep and Snore Jaw advancements are achieved by adjusting the expansion screw,
using the tool provided, per the prescription. Note: The arrows on
Devices: the side of the expansion screw. These indicate the direction to turn
the screw to advance the post. Each 90° turn is 0.1mm.
ProSomnus [CA] Forward Adjustment:
1. 2. 3. 4.
IMPORTANT!
Hold upper tray with Fit the expansion tool Rotate the expansion tool Count your turns and
expansion screw facing you. into the adjustment 90° in the direction of the repeat adjustments on
Locate yellow reference keyhole. arrow to advance forward. both sides.
arrow on device.
ProSomnus [CA] Backward Adjustment:
1. 2. 3. 4.
IMPORTANT!
Hold upper tray with Fit the expansion tool Rotate the expansion Count your turns and
expansion screw facing you. into the adjustment tool 90° in the direction repeat adjustments on
keyhole. opposite of the arrow. both sides.
9ProSomnus [CA] Advancement Tables:
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.
Starting Position +5.0mm
ProSomnus [CA] Standard, (Upper [CA] Arch + Lower 0 Arch):
Reverse Bite
(90 o Screw Starting Forward (90 o Screw Turns)
Turns) Position
90o Screw Turns -10 -5 0 5 10 15 20 25 30 35 40 45 50
Expansion -1.0 -0.5 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Screw Adj. (mm) mm mm mm mm mm mm mm mm mm mm mm mm mm
ProSomnus [CA] with Additional Lower Advancement Arch, (Upper [CA] Arch + Lower +5.0mm Arch):
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 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.5 10.0 10.5 11.0
Adj. (mm) mm mm mm mm mm mm mm mm mm mm mm mm mm
10ProSomnus [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
Starting Position +3.0mm opposite direction to move post to the back of the arch.
ProSomnus [CA] LP, (Upper LP [CA] Arch + Lower 0 Arch):
Starting
Position Forward Advancement
Screw Turns 0 5 10 15 20 25 30 34
(Forward 90°)
Bite Position (mm) 0.0 0.4 0.9 1.3 1.8 2.2 2.6 3.0
mm mm mm mm mm mm mm mm
ProSomnus [CA] LP with Additional Lower Advancement Arch, (Upper [CA] LP Arch + Lower +3.0mm Arch):
Starting Position Forward Advancement
Screw Turns 0 5 10 15 20 25 30 34
(Forward 90°)
Bite Position (mm) 3.0 3.4 3.9 4.3 4.8 5.2 5.6 6.0
mm mm mm mm mm mm mm mm
11ProSomnus [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.
Fig 1a
1) Hold the upper arch perpendicular to the lower arch, such that
the Herbst arm is straight up and down:
Fig 1b
2) To advance each side by 0.1mm, position the .adjustment tool
straight forward as shown in Fig 1a. Advancement Markings
(Raised lines on device 6 4 2 0mm
3) Rotate 90° in the direction of the arrow on the.Herbst arm as provide referece of
advancement location)
shown in Fig 1b. Repeat on the other side.
4) To reduce advancement, rotate in the opposite direction of the L
arrow shown in Fig 1b. Repeat on the other side.
L
5) Confirm adjustment position of the Herbst arm by holding the 1 3 5 7
wrench next to the Herbst arm as shown in Fig 2.
Fig 2
ProSomnus [PH] Adjustment Table:
Reverse Bite Starting
Forward (90 o Turns)
(90 o Turns) Position
90° Turns -10 -5 0 5 10 15 20 25 30 35 40 45 50 55 60
Herbst -1.0 -0.5 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0
Arm Adj. mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm
(mm)
12STORAGE
Keep out of reach of small children and pets. Consult instructions for use
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. Manufacturer
WARRANTY AND REPAIR Non-sterile
Terms and Conditions
ProSomnus Sleep Devices carry a service warranty of 3 years*
Keep dry
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,
Upper limit of temperature
from original date of manufacture, remains intact.
ProSomnus [PH] Herbst-style Sleep Devices
After structural review of the case, all Herbst-style parts should Caution
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.
Prescription only
*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. Authorized representative in the
European Community
Visit ProSomnus.com (Terms and Conditions Section) for further
information.
Visit ProSomnus.com (Education Section) for a series of European conformity
technique videos.
PATENTED MD 1
Medical Device
1 Single Patient – multiple use
PATENTED MD
13PATENTED
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. 9,808,327
PRO3-061-D (April 2020)
ProSommus Sleep Technologies
5860 West Las Positas Blvd., Suite 25
Pleasanton, CA 94588, USA
Main 844.537.5337 | ProSomnus.com
Leader in Precision OAT®
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