Atos Medical TheraBite Instrucciones De Uso página 10

WARNINGS
If the user feels unexpected pain at any time while using the
TheraBite system, the user should immediately stop using the
product and should immediately contact his or her clinician.
Injury may occur if excessive force is applied while using the
TheraBite system, especially in users with weakened dentition,
periodontal disease, weakened bones or joints, or gap-bridging
plates. Users should disclose any such condition to their clinician
before using the TheraBite system and should exercise extreme
caution while using the product.
Before commencing any rehabilitation regimen involving
the TheraBite system, all users should receive a thorough,
professional evaluation by a clinician who is properly trained
in the diagnosis of mandibular dysfunction. All therapeutic
programs and rehabilitation regimens involving the TheraBite
system should include regular monitoring, review, and evaluation
by a clinician.
CAUTIONS
The TheraBite system is intended for single-patient use only.
Do not expose the TheraBite system to direct sunlight and
excessive moisture. Do not expose the TheraBite system to
extreme temperatures.
Do not sterilize the TheraBite system. Sterilization processes
may weaken the materials out of which the device is manufactured,
as well as the bonding of the mouthpieces, and cause failure
under load.
Always handle the TheraBite system with care.
Product description [Fig. 1-5]
The TheraBite Jaw Motion Rehabilitation System consists of:
• The Jaw Mobilizer (1 pc) [Fig. 1] including the following parts:
a. Fine Adjustment Knob [Fig. 1a]
b. Lever [Fig. 1b]
c. Range Setting Arm [Fig. 1c]
d. Upper Mouthpiece [Fig. 1d]
e. Lower Mouthpiece [Fig. 1e]
• Bite Pad (4 pcs) [Fig. 2]
• Hand-Aid (1 pc) [Fig. 3]
• Range of Motion Scale (30 pcs) [Fig. 4]
• Carrying Bag (1 pc) [Fig. 5]
• User Manual (1 pc)
• Patient Progress Log (1 pc)
CAUTION: The components of the jaw mobilizer are not
detachable. Any attempt to detach the parts e.g. the mouthpieces,
can weaken the device and cause failure under load.
How does the TheraBite system work?
The TheraBite system is a hand-operated system with adjustable
range that is designed to assist users to improve the range of motion
and strength of the jaw. The jaw mobilizer is held in the hand during
use, with the mouthpieces placed between the upper and lower front
teeth. Pressure on the Lever, applied by the user, provides either
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