OraSTRETCH PRESS JAW MOTION REHAB SYSTEM User manual

ORASTRETCH® PRESS
JAW MOTION REHAB SYSTEM
INSTRUCTION MANUAL
AND TRACKING LOG
READ INSTRUCTIONS BEFORE USE FOR
SAFETY, USAGE, AND TO AVOID INJURY.

2
GENERAL INFORMATION
Overview___________________________________
The ORASTRETCH® Press Jaw Rehab System is a medical device to prevent
and treat a restricted mouth and for therapy of jaw and mouth dysfunction.
Users and healthcare providers should read this instruction manual for
information on safety, usage, maintenance, and care of the ORASTRETCH®
Press device. Users with further questions should contact their doctor.
Function___________________________________
The ORASTRETCH® Press Jaw Rehab System works by squeezing the handles
to move the mouthpieces apart along the anatomical curved motion of the
jaw up to 50mm wide. A user’s hand provides the force to push apart the
jaw for stretching of tissues and mobilizing the joint. The unit can also
off er resistance for muscle strengthening. The ORASTRETCH® Press device
can be used to treat the jaw joints, muscles and hypomobility (trismus),
for post-operative rehabilitation, and prophylactically to prevent trismus.
DISCLAIMER: No promise or guarantee of results is being made or
implied. Patient outcomes will vary. The device scale is approximate and
should be used to track progress only.
Safety_____________________________________
The ORASTRETCH® Press Jaw Rehab System is user controlled allowing users
to avoid hyper-extension and excessive force over the small distance of
jaw motion. A limit screw is included for the provider or user to set a
maximum opening and prevent over-stretching.
As a medical device, the ORASTRETCH® Press device is available by recom-
mendation of a licensed health care professional who understands the
usage and purpose of the ORASTRETCH® Press device. A prescription may
be required for this device, and varies by country. This instruction manual
is subject to review and periodic updates. Please review this manual
carefully before prescribing and/or use of the ORASTRETCH® Press device.
DISCLAIMER: The ORASTRETCH® Press device is a manually controlled
medical device, and should not be used without the consultation and
direction of a health care professional. As a manually controlled device,
the user must take care to proceed slowly with therapy and to avoid any
sharp or prolonged pain.

3
FEATURES
Product Specifications_________________________
1............................Mouthpieces 4.....................................Scale
2.............................Limit Screw 5..........................Scale Marker
3...................................Handles
Accessories_________________________________
Mouthpiece Bitepads Carrying Bag
MIO Patient Scale Manual and Tracking Log
Contents___________________________________
2.................General Information 7.............Warning and Cautions
3..................................Features 8-9......................Tracking Logs
4...................Indication & Usage 10..................................Notes
5..........................Rehabilitation 11.............................Warranty
6............................Maintenance 12..........................Order Form

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Indications_________________________________
The ORASTRETCH® Press device is indicated for orofacial post-surgical
rehab; limited range-of-motion of the jaw and mouth, trismus or jaw
hypomobility; for facial or muscle pain; and for temporomandibular joint
dysfunction. Patients should consult with a health care professional to
determine if the ORASTRETCH® Press device is an appropriate treatment for
their medical conditions.
Contraindications____________________________
The ORASTRETCH® Press device is contraindicated for patients with
weak, weakened, fractured, or infected bones of the upper and lower
jaw (maxilla and mandible); or patients suff ering from ankylosis,
osteomyelitis, or osteoradionecrosis of the jaw.
INDICATIONS
USAGE INSTRUCTIONS
The ORASTRETCH® Press device was designed to assist patients to stretch,
mobilize and train their jaw and mouth:
Bitepad
Application
• Peel off the backing from the foam pads.
• Apply a pad to the upper and lower biteplate.
• Raise the ORASTRETCH® Press device and insert the
biteplates into the mouth. Align teeth and bite down
on the pads to strengthen bitepads’ adhesion.
Adjustable
Safety
Screw
• Thread limit screw into hole on upper handle.
• Squeeze the handles to move the biteplates apart.
• Rotate the limit screw to force the device closed
to maximum opening desired. Use the scale as an
approximate guide.
Basic Use
• Raise the ORASTRETCH® Press device and insert the
biteplates between the upper and lower teeth.
• Squeeze the handles to move the biteplates apart.
Measuring
• Squeeze device open to a light stretch and note
scale marker’s position in relation to the scale.
• Record opening at start and end of each session.
The ORASTRETCH® Press device was designed to be small and light for
portability. Use it at home, at work, or on vacation, and do not skip or
discontinue usage without instructions from your health care provider. If
you are experiencing sharp or prolonged pain, contact your doctor.

5
Suggested Treatments*_______________________
7-7-7
Stretch
• Insert the device, and squeeze the biteplates apart.
• Hold the device open for 7 seconds. Release.
• Repeat 7-second hold for 7 repetitions.
• Perform 7 times a day.
5-5-30
Stretch
• Insert the device, and squeeze the biteplates apart.
• Hold open for 30 seconds. Release.
• Repeat 30-second hold for 5 repetitions.
• Perform 5 times a day.
Passive
Motion
• Insert the device. Slowly squeeze the device open.
• Slowly release the squeeze to close the device.
• Repeat opening and closing for 5 minutes.
• Perform 3 times a day.
Strength
Training
• Insert the device. Slowly squeeze the device open.
• Bite down against the open device and hold for 5
seconds. Release. Repeat 10 times.
• Perform 3 times a day.
Muscle
Training
• Insert the device. Slowly open and close the device.
• Try to keep your teeth lightly in contact with the
pads as they move.
• Repeat opening and closing for 5 minutes. Perform
3 times a day.
*These are suggested protocols and should only be followed as specifi ed
by a health care provider. Only use the device as instructed by provider.
Tracking___________________________________
Measure your opening at the beginning and end of each therapy session.
This manual contains a log for the user to record their opening. Keep
track of the user’s opening and changes over time. Share this informa-
tion with the healthcare provider, so they may evaluate your progress
and make therapy changes as needed. Measurements by the device or
paper scale are approximations for use with progress tracking.
Therapy Compliance__________________________
Stretching, passive motion and muscle training therapies only work with
repeated daily therapy. Success in recovering and increasing range-
of-motion requires commitment and dedication to your rehabilitation.
Progress is often slow with improvements noticeable after weeks of rehab.
REHABILITATION

6
MAINTENANCE
Care______________________________________
Replace or cover the bite pads with a new pad as desired. Apply bite
pads only when the device is dry. If bitepads do not stick adequately,
lightly rough the mouthpiece with nail fi le or heat with a hair dryer to
improve adhesion.
Store the ORASTRETCH® Press device in its convenient carrying bag when
not in use to help keep it clean. Discoloration of the device may occur.
It may be caused by direct sunlight, minerals in the water, extreme
temperatures, and prolonged moisture exposure. Keep dry and out of
direct sunlight.
Cleaning___________________________________
Clean only the mouthpieces of the device. For basic cleaning rinse
the mouthpieces and pads with water or antiseptic mouthwash. For
more extensive cleaning, use a toothbrush and toothpaste to brush the
mouthpieces and pads clean. Wipe and allow to fully dry.
Do NOT fully submerge or allow the device to get completely wet. Do
NOT put the OraStretch press in the dishwasher. If the device is wet,
wipe, shake dry, and allow to fully dry out.
You may also use soap and warm water to clean the ORASTRETCH® Press
device. Thoroughly rinse the mouthpieces, shake out any remaining
liquid and allow to completely dry on clean paper or cloth towel. If the
device needs to be cleaned beyond the mouthpieces, spot clean that
area only and make sure to fully dry the unit.
Do not use alcohol to clean the mouthpieces, as it may interfere with the
adhesion of the pads. Do not use chemical agents or autoclave systems
to clean or sterilize the ORASTRETCH® Press device, as they may weaken
the device.
Additional Information________________________
CranioMandibular Rehab, Inc. focuses on the therapeutic needs of head,
neck, face, and jaw patients.
For customer service, more information or to order additional
ORASTRETCH® Press devices, accessories, or other products, please contact
CranioMandibular Rehab, Inc at 1-800-206-8381 or visit us on our web
site at www.craniorehab.com.

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WARNING: The ORASTRETCH® Press device is capable of signifi cant
force on the user’s jaw, mouth and teeth, which may cause injury
or damage to tissues, dentition, and/or dental/orthodontic appliances.
Patients with weak or damaged dentition, bones, joints obturators, and
gap-bridging spans should inform their doctor of such conditions and
use extra caution with the ORASTRETCH® Press device. Stop use of the
ORASTRETCH® Press device if the user feels sharp, extended, or unexpected
pain, and contact the prescribing health care provider. Continued use
with pain may cause injury.
WARNING: Do not use the ORASTRETCH® Press device for excessive
periods of time, with excessive force, or in a manner that does not follow
your health care provider’s instructions. Before using the ORASTRETCH®
Press device, all users should be evaluated, diagnosed, and instructed
by a health care professional on the need for and use of the device. All
treatment programs and protocols should be regularly monitored and
reviewed by the health care provider. Deviating from protocols and
health care provider instructions may cause short- or long-term damage.
WARNING: Do not sterilize the ORASTRETCH® Press device. The
ORASTRETCH® Press device is intended for single-patient use and is non-
sterile. Care should be taken with patients susceptible to infection in
applicable areas. Sterilization may weaken the device to cause injury,
and sharing devices could spread infection.
WARNING: Users should inspect the device carefully before each
use. The device and its accessories should be free from damage and
cracking. Use of a damaged or cracked device may cause failure of the
device or injury.
CAUTIONS:
• Only use the ORASTRETCH® Press Jaw Rehab System under the guidance
and instruction from your doctor or therapist.
• Do not expose the ORASTRETCH® Press device to excessive heat, cold,
sunlight, or moisture, as it may weaken or discolor the device.
• Do not wash the ORASTRETCH® Press device in the dishwasher as it may
weaken or discolor the device.
• Do not disassemble or modify the device, except as instructed by a
healthcare professional as it may weaken the device.
• All scales, paper or on the device, use an approximate gradient for
individual progress tracking. Scales are not intended as a measuring
function for prognosis or specifi c treatment.
WARNINGS AND CAUTIONS

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TRACKING LOG
Severe: 0-15mm Extreme Functional Loss Rehab: No Pads. <9mm: Use mouthpiece side. <6mm: No system fi t. Mod: 15-25mm Major Functional Loss. Rehab: Use with Pads. Mild: 25-35mm Functional Loss. Rehab: Use with Pads.
5
10 15 20 25 30
35mm
40 45 50 55 60
Trismus Functional
Range
Average MIOs Men: 50-60mm Women: 45-55mm
Prevent trismus
with an OraStretch
press jaw motion
rehab system.
Maximum Interincisial Opening (MIO) mm)
Start: ________
Date

9
TRACKING LOG
Severe: 0-15mm Extreme Functional Loss Rehab: No Pads. <9mm: Use mouthpiece side. <6mm: No system fi t. Mod: 15-25mm Major Functional Loss. Rehab: Use with Pads. Mild: 25-35mm Functional Loss. Rehab: Use with Pads.
5
10 15 20 25 30
35mm
40 45 50 55 60
Trismus Functional
Range
Average MIOs Men: 50-60mm Women: 45-55mm
Prevent trismus
with an OraStretch
press jaw motion
rehab system.
Maximum Interincisial Opening (MIO) mm)
Start: ________
Date

10
NOTES

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LIMITED WARRANTY:
The manufacturer warrants to the initial domestic consumer user that the
ORASTRETCH® Press device meets the Manufacturer’s specifi cations and is
free from defects for one-year from purchase of the product by the original
registered user.
This warranty is contingent upon proper usage of the ORASTRETCH® Press
device in the application for which it was intended and shall not extend
or apply to any damage or defect resulting from product misuse, abuse,
neglect, modifi cation, alteration, unusual stress, improper storage or
handling, or disregard for product warnings and cautions.
Except for the express limited warranty set forth above, the manufacturer
grants no warranties with respect to the ORASTRETCH® Press device,
expressed or implied, either in fact or by operation of law, by statute or
otherwise, and the manufacturer specifi cally and expressly disclaims any
implied warranty of quality, warrant of merchantability, warranty of non-
infringement of third-party rights.
The manufacturer’s liability under the above warranty shall be limited to a
replacement with a comparable product when the device is returned to the
manufacturers address. In no event shall the manufacturer be liable for
any special consequential, or incidental damage for breach of warranty.
State limitations may preempt above provisions. This warranty gives you
specifi c legal rights and you may have others granted by your state.
The ORASTRETCH® Press device has been manufactured for:
CranioMandibular Rehab, Inc.
2600 W 29th Ave, #102G, Denver, CO 80211
Tel: [phone] Fax: [phone] www.CranioRehab.com
Medical Technology Promedt Consulting GmbH
Altenhofstrasse 80, 66386 St. Ingbert Germany
[phone] www.mt-procons.com
Patents and Trademarks_______________________
ORASTRETCH® is a trademark of CranioMandibular Rehab, Inc. The
ORASTRETCH® Press Jaw Rehab System is covered by patent US8307745
and protected by United States and international law.
©2013 CranioMandibular Rehab, Inc. Denver, CO.
Lot: MAN-OSP-0315 Revised: 03-23-2015

ACCESSORIES
Item Description
JAW REHAB SYSTEM MOUTHPIECE BITEPADS
Bitepad Pack - 1/8” (3mm) thick
4 pads, 2 sets.
Edentulous Bitepad Pack - 3/8” (9.5mm) thick
4 pads, 2 sets.
ORASTRETCH DYNAMIC BANDS - For Dynamic Stretching.
OraStretch Dynamic Bands
Pack of 4 - Alternative for progressive stretching.
RANGE-OF-MOTION SCALES - Improved for small ROMs and simple usage.
OraStretch ROM or MIO Scales
Packs of 50.
THERMAL THERAPY KIT
JawBra and Gel Packs (4) - Soft compressive head wrap and
hot-cold gel packs to reduce swelling and pain of the face
and joint.
TO ORDER: Visit www.craniorehab.com or call us at 1-800-206-8381.
*Prices subject to change, S/H, and other charges.
ORASTRETCH® MIO Scale Usage
See scale instructions for complete information.
Vertical Range
Lateral Scale
Severe: 3-12mm Rotational: 6-35mm Alt Scale: 35-50mm
Protrusion Scale
0-15mm 0-15mm