ProSomnus Sleep and Snore Devices - PATIENT INSTRUCTIONS FOR USE
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ProSomnus® Sleep and Snore Devices
PATIENT INSTRUCTIONS FOR USE
1
TABLE OF CONTENTS INDICATIONS
The ProSomnus Sleep and Snore Devices are intended to reduce
night time snoring and mild to moderate Obstructive Sleep Apnea
Introduction........................................................................................... 2
(OSA) in adults.
Indications............................................................................................. 2
Contraindications................................................................................... 2 CONTRAINDICATIONS
Warnings............................................................................................... 2 The device is contraindicated for patients who:
• Have Central Sleep Apnea.
Precautions............................................................................................ 2 • Have severe respiratory disorders.
• Have loose teeth or advance periodontal disease.
Directions for Daily Use......................................................................... 3
• Are under 18 years of age.
Homecare Cleaning Instructions........................................................... 3
Storage.................................................................................................. 3 WARNINGS
Advancement Instructions.................................................................. 3-7 Use of the device may cause:
• 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
PRECAUTIONS
Devices.
Patients should consider their medical history, including history of
These FDA cleared devices comply with applicable international
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.
EACH PROSOMNUS SLEEP AND SNORE DEVICE PACKAGE
INTRODUCTION CONTAINS:
ProSomnus Sleep Devices are intended to reduce snoring and mild to • 1 or more lower arches
moderate Obstructive Sleep Apnea (OSA) by holding your lower jaw • 1 or more upper arches
forward during sleep. Your device may have a compliance sensor. The • Instructions for use
compliance sensor logs the time the device is worn. • Storage case(s)
Your dentist prescribes the amount of advancement increments Additionally, ProSomnus [CA] Sleep and Snore Device packages
according to your treatment plan. ProSomnus Sleep Devices are contain an adjustment key. ProSomnus [PH] Sleep and Snore
single patient use, patient specific, simple to use, comfortable and Device packages contain an adjustment key and/or wrench.
easy to clean.
Material content: Polymethylmethacrylate (PMMA).
Ball Clasps: Medical grade stainless steel.*
2
[PH] Herbst Arms & [CA] Jackscrew: Medical grade stainless Note: Mouthwash, bleach solutions, denture cleaners or abrasive
steel.* toothpaste may harm the device.
Gold Colored Screw: Titanium nitride coated medical grade
stainless steel.*
*Stainless steel contains nickel and chromium. Meets National STORAGE
Institute for Occupational Safety and Health standards. Keep out of reach of small children and pets.
The ProSomnus Sleep Device should be stored in a cool, dry place.
DIRECTIONS FOR DAILY USE OF THE PROSOMNUS SLEEP Ensure the device is not exposed to extreme temperature in excess of
DEVICES 60°C/140°F.
1. Insert prior to sleep.
2. Inspect the device prior to use. Contact your prescriber if you ADVANCEMENT INSTRUCTIONS
observe any abnormalities. ProSomnus MicrO2 and [IA] Sleep and Snore Devices:
3. Rinse with water before use. • Jaw advancements are achieved by removing your current upper
4. Select the prescribed arches, sandwich together. or lower arch and inserting the next prescribed arch in the series.
5. Open wide, secure the arches onto your teeth. Advancements up to 12.0mm may be achieved with additional
6. Gently relax your jaw and settle down for a restful night. arches as prescribed by your doctor.
7. To remove the device:
a. First remove the lower arch. Gently open your mouth and place
your thumbs into your cheek areas below the post on both side 4 DEVICES
edges of the device to lift out and remove. COMBINATION ADVANCEMENTS
U0, U2, L0, L1
b. Apply even, upward pressure at the side edges of the device
Upper 0 +
to lift out and remove. 0mm
Lower 0
c. Repeat the same process for the upper arch by applying
downward pressure, using your index fingers. Upper 0 +
1.0mm
Lower 1
Note: Do not remove one-handed, this will place unnecessary
torque on the arch frame and can cause breakage. Upper 2 +
2.0mm
Lower 0
WARNING: Always wear both upper and lower arches together.
Never wear individual arches only. Upper 2 +
3.0mm
Lower 1
HOMECARE INSTRUCTIONS
Note: Sterilization is not required.
Daily:
• After use, thoroughly clean your 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 your appliance completely. Store in the
container. Leave the container open to ensure that your devices dry.
• Daily soaking of your devices is not recommended.
3
ProSomnus [CA] Sleep and Snore Devices:
Jaw advancements are achieved by adjusting the expansion screw,
using the tool provided, per your doctor’s 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.
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.
4ProSomnus [CA] Advancement Tables:
Note: Your ProSomnus [CA] Sleep and Snore Device can be
adjusted within a 12.0mm total titration range. Your dentist will
instruct you on the number of 90° screw turns to make based on
comfort and symptom reduction. Your dentist may provide you 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
*Do not exceed maximum number of turns.
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
5ProSomnus [CA] LP Advancement Tables:
Note: Your ProSomnus [CA] LP Sleep and Snore Device can be
adjusted within a 12.0mm total titration range. Your dentist will
instruct you on the number of 90° screw turns to make based on
comfort and symptom reduction. Your dentist may provide you with
an additional lower arch to achieve additional advancement.
Resetting Upper Post: Turn screw on Upper [CA] LP Arch 90° in
Starting Position +3.0mm the opposite direction to move post to the back of the arch.
*Do not exceed maximum number of turns.
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
6ProSomnus [PH] Sleep and Snore Devices:
• Jaw advancements are achieved by adjusting the Herbst nuts or
pinholes by using the tool provided, per your doctor’s
prescription. Advancements up to 12.0mm may be achieved
with additional arches as prescribed by your doctor. 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 0.1mm, position the adjustment tool on square head
advancer screw as shown in Fig 1a. Rotate 90° in the direction of
the etched arrow on the Herbst arm as shown in Fig 1b. Repeat
on the other side.
3. To reduce advancement, rotate in the opposite direction of the
etched arrow.
4. A ruler is laser etched on the wrench handle to check the
advancement throughout treatment as shown in Fig 2.
ProSomnus [PH] Adjustment Table: *Do not exceed maximum number of turns.
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)
7Consult instructions for use
Manufacturer
Non-sterile
Keep dry
PATENTED
Upper limit of temperature
ProSomnus® and MicrO2® are Registered Trademarks. ProSomnus,
MicrO2 the “O” logo design and the artwork and designs contained Caution
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 Prescription only
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.
Authorized representative in the
U.S. Patent No. 9,820,882 European Community
U.S. Patent No. 9,808,327
PRO3-060-E (February 2020)
ProSomnus.com European conformity
Leader in Precision OAT®
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