General Instructions; Before Use; Intended Use / Indications - Atos Medical TheraBite Instrucciones De Uso

PART I: GENERAL AND USER
INFORMATION

General Instructions

This User Manual contains general safety, operating, maintenance,
and care instructions for the TheraBite
System . Both clinicians and users should carefully review this User
™
Manual before prescribing or using the TheraBite system. Users
who have any questions about the safety, operation, maintenance,
care, or other use of the TheraBite system after reviewing the User
Manual should consult with their clinician.
This User Manual, which is provided to all users of the TheraBite
system, may be revised periodically and therefore must be reviewed
carefully each time the device is prescribed and used.

Before Use

The TheraBite system should not be used in any manner until the
patient has consulted with, and received proper instructions from,
his or her treating clinician.
Before the TheraBite system may be used for the first time, the
maximum opening of the TheraBite device appropriate for each
individual user must be determined and set by the user's clinician.
Prior to each use, carefully inspect the product to ensure that it
is undamaged and that all components, parts and accessories are
complete and in proper condition. Do not use the TheraBite system
if the product, or any of its components, parts, or accessories, show
any signs of cracking or other structural damage.

Intended use / Indications

The TheraBite system is indicated for use in individuals who
are restricted in their ability to open their jaws (trismus or jaw
hypomobility).
The TheraBite system is indicated for use in individuals who
experience pain in the joints and/or muscles of the jaw.
The TheraBite system may also be used as a rehabilitation tool
for postoperative physical therapy of the jaw.
Patients at risk of developing limited jaw motion may consider
the TheraBite system for prophylactic use on the advice and under
the supervision of a trained clinician.
Prospective users should consult with their clinician to determine
whether the TheraBite system is appropriate for their individual
conditions.
Contraindications
The TheraBite system should not be used by individuals who have
or may have a fracture in the maxilla or mandible (upper or lower
jaw) or other weaknesses of the bones of the jaw.
Patients with infections of the jaw, osteomyelitis, or osteoradionecrosis
of the jaw should not use the TheraBite system.
Jaw Motion Rehabilitation
®
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