OraSTRETCH PRESS JAW MOTION REHAB SYSTEM Instruction Manual

ORASTRETCH® PRESS
JAW MOTION REHAB SYSTEM
INSTRUCTION MANUAL
AND TRACKING LOG
READ INSTRUCTIONS BEFORE USE FOR
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 O
RASTRETCH
®
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 recom­mendation 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.
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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 O
RASTRETCH
®
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.
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