Atos Medical TheraBite JAW MOTION REHABILITATION SYSTEM User manual

Instructions for use
Region 1
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LANGUAGES
English................................................................. 8-17
DEutsch.............................................................. 18-28
nEDErlanDs .................................................. 29-39
Français............................................................ 40-50
italiano.............................................................. 51-61
Español.............................................................. 62-72
português....................................................... 73-83
תירבע....................................................................................84-93
orDEring inForMation................................94
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ENGLISh
Content
part i:
gEnEral anD usEr inForMation......................................................9
part ii:
instructions For thE clinician....................................................16
part iii:
aDDitional inForMation....................................................................17
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PART I: GENERAL AND USER
INFORMATION
General Instructions
This User Manual contains general safety, operating, maintenance,
and care instructions for the TheraBite
®
Jaw Motion Rehabilitation
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 rst 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.
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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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opening force or resistance to closing. [Fig. 6]
The TheraBite system utilizes repetitive passive motion and
stretching. The jaw mobilizer guides the mandible (lower jaw) along
an anatomically correct, curved pathway during opening and closing
movements. [Fig. 6]
The TheraBite system can help achieve:
1. Proper jaw opening:
• by stretching connective tissues
• by mobilizing joints
• by strengthening muscles across their full range of motion
2. Reduction in pain and inammation
• Passive mobilization of the joint
Research has indicated that mobilization is beneficial in the
management of joint disorders. Motion is necessary to prevent the
degeneration of cartilage, the layer of tissue that lines most of the
joint surfaces. In many cases, movement may stimulate joint healing
and reduce pain and swelling.
By stretching and relaxing muscles, gradual mobilization exercises
can help individuals with muscle pain to improve their range of
motion. Passive motion can also provide therapeutic advantages,
especially following an operation.
How to use the TheraBite system
How to put on the Bite Pads [Fig. 7-8]
The TheraBite system comes with self-adhesive bite pads to protect
the user’s teeth. The clinician may, in the exercise of his or her
independent clinical judgment, stack or trim the bite pads for extra
protection.
• Peel off the backing to expose the sticky surface. [Fig. 7]
• Attach one bite pad to the Upper Mouthpiece and one to the Lower
Mouthpiece. [Fig. 8]
• Apply pressure with your thumb or similar means to ensure
sufcient initial adhesion to the mouthpieces. Pressure and warmth
under a prolonged period will make the bite pads tackier.
• To enhance adhesion of the bite pads to the mouthpieces, apply
the bite pads to the mouthpieces before going to bed and leave
them on overnight.
The adhesive bond created by the pressure-sensitive adhesive on
the bite pads increases with time, such that the longer the bite pads
sit on the mouthpieces prior to using the device, the more strongly
they will tend to adhere.
If the bite pads become worn, replace them with the two extra
bite pads that are included with the TheraBite system.
For individuals with no teeth (edentulous) or a limited number
of teeth, bite pads with thick cushioning for customized trimming
can be ordered separately. Bite pads for pediatric use are provided
with the TheraBite system for children.
Additional bite pads can also be ordered separately.
CAUTION: bite pads or parts of bite pads that become loose
during use might obstruct breathing. Therefore make sure
that the bite pads are securely attached to the mouthpieces
after trimming and bonding.
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How to use the Jaw Mobilizer [Fig. 6]
Hold the jaw mobilizer with the Lever up and with the mouthpieces
inside your mouth. Squeeze the Lever gently to move the Lower
Mouthpiece downward, following the natural motion of the jaw.
How to use the Fine Adjustment Knob [Fig. 9]
The Fine Adjustment Knob can be used to slow or stop the motion
created by the jaw mobilizer.
• Turn the knob all the way in (counter/anti-clockwise) to stop the
Lever in the highest position. [Fig. 9a]
• While squeezing gently, turn the knob out (clockwise) to allow
the lower mouthpieces to move down slowly. [Fig. 9b]
• The Lever may be released at any time without turning the Fine
Adjustment Knob.
How to use the Hand-Aid [Fig. 10]
The hand-aid is a tool designed to hold the Lever down and maintain
opening during stretching or isometric exercises.
To install the Hand-Aid:
• Hold the jaw mobilizer in your left hand, and loosen the Fine
Adjustment Knob so that the Lever can be squeezed all the way
down.
• Take the hand-aid in your right hand with the narrow groove on
top.
• Squeeze the Lever down, and place the open side of the hand-aid
over the lowest part of the Lever. [Fig. 10a]
• Rotate the hand-aid one-quarter turn clockwise, so that the handle
groove is over the handle, and release the squeeze.
• To use, slide the hand-aid towards the mouth. [Fig. 10b]
• To release, push the hand-aid away.
How to use the Range of Motion Scale
[Fig. 11 & 12]
The range of motion scale is designed to make mandibular motion
measurement quick and easy. An area to record your progress is
printed on the reverse side of the scale and a progress log comes
with your device to track your progress.
To measure the Maximal Incisal Opening
[Fig. 11]
• Open your mouth as widely as possibly without discomfort.
• Place the range of motion scale so that the notch rests on the edge
of a lower incisor (tooth).
• Rotate the range of motion scale until it contacts an upper incisor.
• Take the reading at the point of contact.
• Record the measurement on the reverse side of the range of motion
scale or in the separate patient progress log.
To measure Lateral Movement [Fig. 12]
• Rest the range of motion scale against the lower incisors with the
teeth in gentle occlusion (the upper and lower teeth close together).
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• Align the arrow with an interproximal space (space between two
upper teeth). [Fig. 12a]
• Move the mandible laterally (side-to-side), and read the measurement
on the Lateral Scale opposite the new position of the space. [Fig.
12b & 12c]
• Record your progress on the reverse side of the range of motion
scale or in the separate patient progress log.
Getting started [Fig. 13]
Adjust the Fine Adjustment Knob so that the Lever moves freely.
Let the Lever come all the way up.
• Hold the jaw mobilizer in the hand most comfortable for you.
• Relax and open your mouth.
• Place the mouthpieces between your upper and lower teeth, inside
your lips. [Fig. 13a]
• Your front teeth should just touch the inside rim of the Upper
Mouthpiece.
• Be careful to hold the jaw mobilizer level. Gently squeeze the
Lever to push the Lower Mouthpiece down against your lower
teeth. [Fig. 13b]
• Release at any time by relaxing your hand. [Fig. 13c]
Always begin and end each session by recording your beginning
and ending measurements in the patient progress log. This will give
you an accurate assessment of your progress, and will guide your
clinician in directing your treatment.
Care and cleaning
Use soap/detergent and water to clean the TheraBite system. Rinse
well, shake off excess water, and dry.
The range of motion scale is a disposable product, which should
not be cleaned.
After cleaning the device, examine the bite pads on the Upper
and Lower Mouthpiece and replace them if necessary. Replace bite
pads only after ensuring that the mouthpieces are dry.
Caution: The mouthpieces are made of a material that tends
to retain moisture. Therefore, do not attempt to use the jaw
mobilizer until the mouthpieces are dry of all moisture. Do not
soak the device in any liquid. Damage to the unit may result if
force is applied to mouthpieces that are wet.
Caution: Avoid using a dishwasher to clean the TheraBite
system. Prolonged cleaning with a dishwasher may weaken the
bonding of the mouthpieces or cause discoloring.
Caution: Do not steam autoclave or gas autoclave the TheraBite
system. Sterilization processes may weaken the bonding of the
mouthpieces and cause failure under load.
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Daily use
It is very important that the rehabilitation program recommended by
your clinician is followed on a regular basis. To help you maintain
your rehabilitation program, whether at work, while traveling, or
at play, a Carrying Bag is included with the TheraBite system. The
Carrying Bag is designed to keep all the components and accessories
of the TheraBite system together. The Carrying Bag also has room
for tissues and other convenient items.
Be sure to take the TheraBite system with you wherever you go
and continue your rehabilitation program at regular intervals during
both work and recreation, as your clinician has advised. Do not miss
a session! Always measure and record the opening of your mouth
before and after each session, using the range of motion scales and
the patient progress log.
Rehabilitation programs for the
TheraBite system
All users should receive adequate advice and instruction, as well as
a personalized rehabilitation program, from their clinicians prior
to using the TheraBite system. All rehabilitation programs should
include regular monitoring, review, and evaluation by a properly
trained clinician.
A commonly used exercise regimen is 7-7-7: Seven times per
day. Seven stretches each time. Each stretch held for seven seconds.
Individuals who suffer from muscle and/or joint pain may also
benet from longer stretch exercises in their rehabilitation programs.
An exercise regimen with longer stretches is 5-5-30: Five times
per day. Five stretches each time. Each stretch held for 30 seconds.
After having used the TheraBite system for several months, you
may be able to reduce your exercise regimen. Consult your clinician
before making any changes to your rehabilitation program and/or
exercise regimen.
Rehabilitation program for wider jaw
opening
Stretching program
• Place properly cushioned mouthpieces between your teeth.
• Following the instructions of your clinician, slowly squeeze the
Lever to open the mouthpieces. (Do not bite on the mouthpieces!)
• Allow your jaw to follow along with the motion of the mouthpieces.
(Be careful not to tilt the jaw mobilizer up or down as you squeeze.
Tilting may cause your jaw to move incorrectly.)
• Hold open as long as instructed by your clinician.
• Relax the squeeze, allowing your mouth to slowly close.
• Rest and repeat as instructed. If you nd it difcult to hold the
mouthpieces open, you may wish to use the hand-aid.
• A very slow opening motion may help to reduce pain or discomfort
and may help to avoid muscle spasm.
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For slow opening:
• Turn the Fine Adjustment Knob all the way in (counter/anti-
clockwise).
• Gently squeeze the Lever with one hand while turning the Fine
Adjustment Knob outward (clockwise) with the other hand.
• Continue to open until you have reached the limit prescribed.
• Relax, rest, and repeat.
Rehabilitation program to gain strength
Resisted Movement
• Insert the Mouthpieces and squeeze until you reach the opening
recommended by your clinician.
• Without releasing the Lever, bite against the mouthpieces.
• Slowly release the Lever, allowing your mouth to close against
the hand pressure. Your clinician will advise you how hard to
squeeze while closing.
• Rest briey, then repeat.
Rehabilitation program to develop
coordination
Reeducation
The anatomically correct motion of the jaw mobilizer helps to train
your jaw to move naturally.
• Insert the mouthpieces and bite very gently.
• Open your mouth while squeezing the Lever just hard enough to
keep your teeth lightly touching the bite pads.
• After opening as wide as you comfortably can, release the Lever
slowly and close, still keeping your teeth in contact with the bite
pads.
• Repeat as often as instructed by your clinician so that your jaw
muscles are trained to move correctly.
Troubleshooting
A build-up develops on the mouthpieces of
the Jaw Mobilizer
Possible cause 1: Build-up may be due to dirt that has accumulated
on mouthpieces after long periods of use.
Possible cause 2: Build-up may be due to the presence of calcium
or other minerals in tap water.
What to do:
• Clean the mouthpieces with a non-glycerin alcohol.
• Use an emery board (nail le) to lightly le the surface of the
mouthpieces.
• Rinse off the residue completely.
• Dry the mouthpieces and apply new bite pads.
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Bite Pads do not stick properly to mouthpieces
Possible cause 1: bite pads may not stick properly if the mouthpieces
contain moisture.
Possible cause 2: The bite pads were not properly placed on the
mouthpieces.
What to do:
• Always make sure the mouthpieces are dry and free of build-up
before applying the bite pads.
• Heat will make the adhesive on the bite pads tackier. Warm the
mouthpieces under low heat with a hair dryer to evaporate moisture.
Allow the mouthpieces to cool down to room temperature.
• Review the User Manual regarding bite pad application. Apply
sufficient pressure to ensure good initial adhesion to the
mouthpieces.
Discoloration occurs on the Jaw Mobilizer’s
surface and mouthpiece
Possible cause 1: Discoloration may occur due to the presence of
iron in tap water.
Possible cause 2: Discoloration may also occur when the jaw
mobilizer is exposed to direct sunlight, excessive moisture, or
extreme temperatures.
In most cases, discoloration is purely cosmetic, and will not decrease
the effectiveness of the device.
What to do:
• Do not soak the device in any liquid. Always dry the jaw mobilizer
well after use and cleaning.
• Clean the mouthpieces with a non-glycerin alcohol.
• Keep the jaw mobilizer away from direct sunlight, excessive
moisture, and/or extreme temperatures.
• When not in use, store the jaw mobilizer inside the Carrying Bag
in a cool dry place.
Read the User Manual carefully to enhance your understanding of
the appropriate use and care of the TheraBite system. Additional
User Assistance Information is set forth in Part V, below.
PART II: INSTRUCTIONS FOR THE
CLINICIAN
Setting Maximum Opening of the Jaw Mobilizer [Fig.
14-15]
Maximum openings of approximately 25 to 45 millimeters can be
set by the position of the Range Setting Arm. [Fig. 14]
• Hold the device on its side and apply very gentle pressure to the
Lever – not enough to move the Lower Mouthpiece.
• Use a pointed object (such as a pen or pencil) to push out the pin
that connects the Range Setting Arm to the Lever. [Fig. 15a &
15b]
• Align the Range Setting Arm in the desired position and replace
the pin. (Range change is approximately 5 mm per interval.)
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The TheraBite system can be used without adjusting these settings,
depending on the patient’s ability to understand and implement
instructions for the application of appropriate pressure.
The scale on the jaw mobilizer is for patient reference only. Use
the range of motion scale for more accurate measurement.
PART III: ADDITIONAL INFORMATION
Limited Warranty
Atos Medical (“Manufacturer”) warrants that the TheraBite Jaw
Motion Rehabilitation System meets the Manufacturer’s specications
and is free from manufacturing defects at the time of delivery.
This warranty is contingent upon proper use of the TheraBite
Jaw Motion Rehabilitation System 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, modication, alteration,
unusual stress, or improper storage or handling.
Except for the express limited warranty set forth above, the
manufacturer grants no warranties with respect to the TheraBite
Jaw Motion Rehabilitation System, express or implied, either
in fact or by operation of law, by statute or otherwise, and the
manufacturer specically and expressly disclaims any implied
warranty of quality, warranty of merchantability, warranty of
non-infringement of third-party rights.
The manufacturer´s liability under the above warranty shall
be limited to a refund of the distributor´s purchase price. In no
event shall the manufacturer be liable for the cost of procurement
of substitute goods or for any special, consequential, or incidental
damage for breach of warranty.
Date of Printing
See version number on the back cover.
Trademark
TheraBite is a registered trademark owned by Atos Medical AB,
Sweden.
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Deutsch
Inhalt
TEIL I:
Allgemeine Anweisungen.....................................................20
TEIL II:
Hinweise Für Den Behandelnden Arz.............................27
TEIL III:
Zusätzliche Informationen.....................................................28
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TEIL I: ALLGEMEINE ANWEISUNGEN
Allgemeine Anweisungen und Anwender-
Hinweise
Diese Gebrauchsanweisung enthält allgemeine Sicherheits-,
Nutzungs-, Wartungs- und Pegehinweise für das TheraBite®Jaw
Motion Rehabilitation System™. Sowohl Ärzte als auch Anwender
sollten diese Gebrauchsanweisung sorgfältig lesen, bevor das
TheraBite System verschrieben oder benutzt wird. Anwender, die
nach der Lektüre der Gebrauchsanweisung noch Fragen zu Sicherheit,
Benutzung, Wartung oder Pege des TheraBite Systems haben,
sollten ihren behandelnden Arzt konsultieren.
Diese Gebrauchsanweisung für alle Anwender des TheraBite
Systems kann von Zeit zu Zeit aktualisiert werden und sollte daher
immer sorgfältig gelesen werden, bevor das Produkt verschrieben
oder benutzt wird.
Vor der Verwendung
Vor der Verwendung des TheraBite Systems muss der Patient
seinen behandelnden Arzt konsultiert haben und von diesem eine
angemessene Anleitung für die Nutzung des Produkts erhalten haben.
Vor der ersten Verwendung des TheraBite Systems muss die
maximal zulässige Öffnung des TheraBite vom Arzt für jeden
Benutzer individuell eingestellt werden.
Vor jeder Verwendung ist das Produkt zu überprüfen, um
sicher zu stellen, dass es nicht beschädigt ist und dass alle Teile
sowie Zubehörteile des Produkts vollständig vorhanden und sich
in einwandfreiem Zustand benden. Das TheraBite System darf
nicht verwendet werden, wenn eine der Komponenten Risse oder
andere Beschädigungen aufweist.
Bestimmungsgemäßer Gebrauch /
Indikationen
Das TheraBite System ist für Personen bestimmt, deren Kieferfunktion
eingeschränkt ist (Trismus oder eingeschränkte Kieferbeweglichkeit).
Das TheraBite System ist indiziert bei Personen, die Schmerzen
in den Gelenken und/oder Muskeln des Kiefers haben.
Das TheraBite System kann auch im Rahmen der Rehabilitation
nach postoperativer Physiotherapie des Kiefers eingesetzt werden.
Patienten, die eine eingeschränkte Kieferbewegungsfähigkeit
entwickeln, können das TheraBite System auf Anraten und unter
Beobachtung des behandelnden Arztes prophylaktisch verwenden.
Interessierte Personen sollten ihren Arzt konsultieren, um zu
ermitteln, ob das TheraBite System für sie geeignet ist.
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KONTRAINDIKATIONEN
Das TheraBite System sollte nicht von Personen verwendet werden,
die an einer akuten oder vermuteten Fraktur der Maxilla (Oberkiefer)
oder der Mandibula (Unterkiefer) oder anderen Krankheiten der
Kieferknochen leiden.
Patienten, die unter Kieferinfektionen, Osteomyelitis oder
Osteoradionekrose des Kiefers leiden, sollten das TheraBite System
nicht verwenden.
WARNHINWEISE
Wenn während der Anwendung des TheraBite Systems unerwartet
Schmerzen auftreten, sollte die Anwendung sofort unterbrochen
und ein Arzt aufgesucht werden.
Übermäßige Kraftaufwendung bei Verwendung des TheraBite
Systems kann zu Verletzungen führen. Dies gilt insbesondere für
Patienten mit geschwächtem Gebiss, Peridontalerkrankungen,
geschwächten Knochen oder Gelenken sowie nach einer
Versorgung mit Brücken. Benutzer mit diesen Voraussetzungen
sollten den behandelnden Arzt vor Verwendung des TheraBite
Systems darauf aufmerksam machen und das Produkt nur mit
äußerster Vorsicht anwenden.
Vor Beginn der Rehabilitationstherapie mit dem
TheraBite System sollten die Patienten einer gründlichen
zahnärztlichen Untersuchung durch einen Facharzt für
Kieferheilkunde unterzogen werden. Alle Therapie- und
Rehabilitationsmaßnahmen unter Verwendung des TheraBite
Systems sollten auch die regelmäßige Überwachung, Überprüfung
und Beurteilung durch einen Arzt umfassen.
VORSICHTSMASSNAHMEN
Das TheraBite System ist jeweils nur für einen einzelnen
Patienten bestimmt.
Das TheraBite System vor direktem Sonnenlicht, übermäßiger
Feuchtigkeit und extremen Temperaturen schützen.
Das TheraBite System darf nicht sterilisiert werden. Die
Sterilisation kann das Material, aus dem das Produkt besteht,
schwächen, wodurch sich das Mundstück bei Belastung lösen
könnte.
Behandeln Sie das TheraBite System immer vorsichtig.
Produktbeschreibung [Abb. 1-5]
Das TheraBite Jaw Motion Rehabilitation System besteht aus:
• Kiefertrainer (Jaw Mobilizer) (1 St.) [Abb. 1] mit folgenden Teilen:
a. Rädchen für die Feineinstellung [Abb. 1a]
b. Hebel [Abb. 1b]
c. Einstellarm für die maximale Öffnung [Abb. 1c]
d. Oberes Mundstück [Abb. 1d]
e. Unteres Mundstück [Abb. 1e]
• Bisspolster (Bite Pad), (4 St.) [Abb. 2]
• Arretierscheibe (Hand-Aid), (1 St.) [Abb. 3]
• Messhilfe für die maximale Öffnung (Range of Motion Scale),
(30 St.) [Abb. 4]
• Transporttasche (1 St.) [Abb. 5]
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