Atos Medical TheraBite User manual

IFU
MD
RT

25 mm
30 mm
35 mm
40 mm
45 mm
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bc
d
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1)
2) 3)
© Atos Medical AB, 201308A, REF TM1816
Lateral Scale
4) 5)
6)
7 a) 7 b)

3
10 a)
10 b)
11 a) 11 b)
8) 9)

4
13 c)
12)
13 a)
13 b)

5
14 a)
14 b)
14 c)

6
Disclaimer
Atos Medical offers no warranty - neither expressed nor
implied - to the purchaser hereunder as to the lifetime of the
product delivered, which may vary with individual use and
biological conditions. Furthermore, Atos Medical offers no
warranty of merchantability or tness of the product for any
particular purpose.
Trademarks
TheraBite®is a registered trademark owned by Atos Medical
AB, Sweden. ActiveBand™ is a trademark by Atos Medical AB.

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Manufacturer; Hersteller; Fabrikant; Fabricant; Produttore;
Fabricante; Fabricante; Tillverkare; Producent; Produsent;
Valmistaja; Framleiðandi; Tootja; Ražotājs; Gamintojas;
Výrobce; Gyártó; Výrobca; Proizvajalec; Producent; Producător;
Proizvođač; Proizvođač; Κατασκευαστής; Производител; Üretici;
მწარმოებელი; Արտադրող; İstehsalçı; Производитель; Pro-
dusen; Pengilang; 製造業者; 제조사; 製造商; 制造商;
ןרציה;ןרציה;  
Date of manufacture; Herstellungsdatum; Productiedatum; Date de
fabrication; Data di fabbricazione; Fecha de fabricación; Data de
fabrico; Tillverkningsdatum; Fremstillingsdato; Produksjonsdato
;Valmistuspäivä; Framleiðsludagsetning; Valmistamise kuupäev;
Ražošanas datums; Pagaminimo data; Datum výroby; Gyártás
időpontja; Dátum výroby; Datum proizvodnje; Data produkcji; Data
fabricației; Datum proizvodnje; Datum proizvodnje; Ημερομηνία
κατασκευής; Дата на производство; Üretim tarihi; წარმოების
თარიღი; Արտադրման ամսաթիվ; İstehsal tarixi; Дата
изготовления; Tanggal produksi; Tarikh pembuatan; 製造日; 제조일
자; 製造日期; 制造日期; רוציי ךיראת;רוציי ךיראת;  
Use-by date; Verfallsdatum; Houdbaarheidsdatum; Date limite
d’utilisation; Data di scadenza; Fecha de caducidad; Data de vali-
dade; Används senast: Anvendes inden; Brukes innen; Viimeinen
käyttöpäivä; Síðasti notkunardagur; Kõlblik kuni; Derīguma
termiņš; Naudoti iki; Datum expirace; Felhasználhatóság dátuma;
Dátum najneskoršej spotreby; Rok uporabnosti; Data ważności; Data
expirării; Rok uporabe; Rok upotrebe; Ημερομηνία λήξης; Срок на
годност; Son kullanım tarihi; ვარგისია; Պիտանելիության
ժամկետ; Son istifadə tarixi; Срок годности; Gunakan sebelum
tanggal; Tarikh guna sebelum; 使用期限; 사용 기한; 使用截止日
期; 使用截止日期;
Batch code; Chargencode; Partijnummer; Code de lot; Codice lotto;
Código de lote; Código do lote; Batchkod; Batchkode; Batchkode;
Eränumero; Lotunúmer; Partii kood; Partijas kods; Partijos kodas;
Kód šarže; Sarzs kód; Kód šarže; Številka serije; Kod partii; Codul
lotului; Šifra serije; Šifra serije; Κωδικός παρτίδας; Код на партида;
Parti kodu; სერიის კოდი; Խմբաքանակի կոդ; Partiya kodu; Код
партии; Kode batch; Kod kelompok; バッチコード; 배치 코드; 批
次代碼; 批号; הווצא דוק;הווצא דוק;  
שומישל ןורחא ךיראת;שומישל ןורחא ךיראת;   

8
Product reference number; Produktreferenznummer; Referentienum-
mer product; Numéro de référence du produit; Numero riferimento
prodotto; Número de referencia del producto; Referência do produto;
Referensnummer; Produktreferencenummer; Produktreferansenum-
mer; Artikkelinumero; Tilvísunarnúmer vöru; Toote viitenumber;
Produkta atsauces numurs; Gaminio katalogo numeris; Referenční
číslo produktu; Termék referenciaszáma; Referenčné číslo produktu;
Referenčna številka izdelka; Numer katalogowy produktu; Numărul
de referință al produsului; Referentni broj proizvoda; Referentni broj
proizvoda; Αριθμός αναφοράς προϊόντος; Референтен номер на
продукт; Ürün referans numarası; პროდუქტის საკონტროლო
ნომერი; Արտադրանքի տեղեկատու համարը; Məhsula istinad
nömrəsi; Справочный номер изделия; Nomor referensi produk;
Nombor rujukan produk; 製品参照番号; 제품 참조 번호; 產品參
考號; 产品参考编号; רצומה לש ןיכומיס רפסמ;רצומה לש ןיכומיס רפסמ;   
Do not re-use; Nur zum Einmalgebrauch; Niet hergebruiken; Ne pas
réutiliser; Non riutilizzare; No reutilizar; Não reutilizar; Återan-
vänd ej; Må ikke genanvendes; Skal ikke gjenbrukes; Ei uudel-
leenkäytettävä; Má ekki endurnýta; Mitte taaskasutada; Neizmantot
atkārtoti; Pakartotinai nenaudoti; Nepoužívejte opakovaně; Ne
használja fel újra; Nepoužívajte opakovane; Ne uporabljajte ponov-
no; Nie używać ponownie; A nu se reutiliza; Nemojte ponovno
upotrebljavati; Ne koristiti ponovo; Μην επαναχρησιμοποιείτε; Не
използвайте повторно; Tekrar kullanmayın; არ გამოიყენოთ
ხელახლა; Մեկանգամյա օգտագործման համար; Yenidən isfadə
etməyin; Не подлежит повторному использованию; Jangan
gunakan ulang; Jangan guna semula; 再利用不可; 재사용하지 마십
시오; 請勿重複使用; 请勿重复使用;
רזוח שומישל דעוימ וניא;רזוח שומישל דעוימ וניא;    
Keep away from sunlight and keep dry; Vor Sonnenlicht und
Feuchtigkeit schützen; Niet blootstellen aan zonlicht, droog bewar-
en; Maintenir à l’abri de la lumière directe du soleil et de l’humidité;
Tenere all’asciutto e al riparo dalla luce del sole; Mantener seco y
alejado de la luz solar; Manter afastado da luz solar e da chuva; Håll
borta från solljus och håll torr; Holdes bort fra sollys og holdes tør;
Unngå direkte sollys, holdes tørr; Säilytettävä kuivassa paikassa
suojassa auringonvalolta; Geymið fjarri sólarljósi og haldið þurru;
Hoida kuivas ja eemal päikesevalgusest; Sargāt no saules stariem un
mitruma; Saugoti nuo saulės šviesos ir laikyti sausai; Chraňte před
slunečním zářením a udržujte v suchu; Tartsa a napfénytől távol,
és tartsa szárazon; Chráňte pred slnečným žiarením a uchovávajte
v suchu; Shranjujte na suhem in ne izpostavljajte sončni svetlobi;
Chronić przed światłem słonecznym i przechowywać w suchym
miejscu; A se feri de lumina soarelui și a se menține uscat; Čuvajte
na suhom mjestu i podalje od Sunčeve svjetlosti; Držati dalje od
sunčeve svetlosti i čuvati na suvom; Φυλάσσετε μακριά από το
ηλιακό φως και διατηρείτε τη συσκευή στεγνή; Дръжте далече от
слънчева светлина и съхранявайте на сухо място; Güneş

9
שבי םוקמב ןסחאלו שמשה רואמ קיחרהל שישבי םוקמב ןסחאלו שמשה רואמ קיחרהל שי
        
ışığından uzakta ve kuru tutun; შეინახეთ მზისგან დაცულ
ადგილას და მშრალ მდგომარეობაში; Հեռու պահեք արևի
ճառագայթներից և պահեք չոր տեղում; Gün işığından uzaqda və
quru saxlayın; Берегите от воздействия прямых солнечных лучей
и влаги; Hindarkan dari sinar matahari dan simpan di tempat yang
kering; Jauhkan dari cahaya matahari dan pastikan sentiasa kering;
直射日光および湿気禁止; 직사광선이 닿지 않게 하고 건조한
상태로 유지하십시오; 避免日照並保持乾燥;
避免日照和保持干燥。;
Storage temperature limit; Lagertemperaturgrenze; Maximale
bewaartemperatuur; Limite de température de stockage; Tempera-
ture di stoccaggio; Límite de temperatura de almacenamiento;
Limite da temperatura de armazenamento; Temperaturgränser
för förvaring; Opbevaringstemperaturbegrænsning; Oppbevar-
ingstemperaturgrense; Säilytyslämpötilan raja; Takmarkanir á
hitastigi við geymslu; Säilitustemperatuuri piirmäär; Uzglabāšanas
temperatūras ierobežojums; Laikymo temperatūros riba; Maximální
skladovací teplota; Tárolási hőmérsékletkorlát; Limit skladova-
cej teploty; Omejitve temperature za shranjevanje; Temperatura
przechowywania; Limita temperaturii de depozitare; Ograničenje
temperature skladištenja; Ograničenje temperature skladištenja;
Όρια θερμοκρασίας αποθήκευσης; Граници на температурата на
съхранение; Saklama sıcaklığı sınırı; შენახვის ტემპერატურის
ლიმიტი; Պահպանման ջերմաստիճանի սահմանները; Saxlama
temperaturu həddi; Ограничения температуры хранения; Batas
suhu penyimpanan; Had suhu simpanan; 保管温度制限;
보관 온도 제한; 儲存溫度限制; 储存温度限制;
ןוסחא תרוטרפמט תלבגה;ןוסחא תרוטרפמט תלבגה;    
RT
MAX
MIN
Store at room temperature. Temporary deviations within the
temperature range (max-min) are allowed; Bei Zimmertemperatur
lagern. Temperaturschwankungen innerhalb des Temperaturbereichs
(min.–max.) sind zulässig; Bij kamertemperatuur bewaren. Tijdelijke
afwijkingen van de temperatuur binnen de marge (min-max) zijn
toegestaan; Stocker à température ambiante Des écarts temporaires
dans la plage de température ambiante (max-min) sont autorisés;
Conservare a temperatura ambiente. Sono consentiti scostamenti
temporanei entro i limiti di temperatura (max-min); Almacenar a
temperatura ambiente. Se permiten desviaciones temporales dentro
del rango de temperatura (máx.-mín.); Guardar à temperatura
ambiente. São permitidos desvios temporários dentro do intervalo
das temperaturas (máx-min); Förvara i rumstemperatur. Tillfälliga
avvikelser inom temperaturområdet (max–min.) är tillåtna;
Opbevar ved rumtemperatur. Midlertidige afvigelser i temper-
aturintervallet (maks-min) er tilladt; Oppbevares i romtemperatur.
Midlertidige avvik innenfor temperaturområdet (maks.–min.) er
tillatt; Säilytä huoneenlämmössä. Väliaikainen poikkeama lämpötila-
alueella (suurin-pienin) on sallittu; Geymið við stofuhita. Tímabun-
din frávik innan hitasviðs (lágm.–hám.) eru leyfð; Hoida toatemper-
atuuril. Ajutised nihked temperatuurivahemikus (max–min) on

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lubatud; Uzglabāt istabas temperatūrā. Ir pieļaujamas īslaicīgas
novirzes temperatūras diapazona ietvaros (min.–maks.); Laikyti
kambario temperatūroje. Leidžiami laikini nuokrypiai, neviršijantys
temperatūros intervalo (didž.–maž.); Skladujte při pokojové teplotě.
Dočasné odchylky od teplotního rozsahu (max–min) jsou povoleny;
Tárolja szobahőmérsékleten. Az átmeneti ingadozás a hőmérséklet-
tartományon belül (max.–min.) engedélyezett; Uchovávajte pri
izbovej teplote. Dočasné odchýlky v rámci teplotného rozsahu
(max – min) sú povolené; Shranjujte pri sobni temperaturi. Dovolje-
na so začasna odstopanja znotraj temperaturnega razpona (najv.–
najm.); Przechowywać w temperaturze pokojowej. Dopuszczalne
są przejściowe odchylenia w obrębie zakresu temperatury (maks.
— min.); A se păstra la temperatura camerei. Sunt permise abateri
temporare în intervalul de temperatură (min.–max.); Skladištite pri
sobnoj temperaturi. Dopuštena su privremena odstupanja unutar
raspona temperature (maks. – min.); Čuvati na sobnoj temperaturi.
Dozvoljena su privremena odstupanja unutar temperaturnog opsega
(maks.–min.); Φυλάσσετε σε θερμοκρασία δωματίου. Επιτρέπονται
παροδικές αποκλίσεις εντός του εύρους θερμοκρασίας (μέγιστη-
ελάχιστη); Съхранявайте на стайна температура. Временните
отклонения в температурните диапазони (макс. – мин.) са
разрешени; Oda sıcaklığında saklayın. Sıcaklık aralığı (maksimum-
minimum) içerisinde geçici sapmalara izin verilir; შეინახეთ
ოთახის ტემპერატურაზე. დროებითი გადახრები
ტემპერატურის ფარგლებში (მაქს.-მინ.) დასაშვებია;
Պահել սենյակային ջերմաստիճանում: Թույլատրվում են
ժամանակավոր տատանումներ ջերմաստիճանի ընդգրկույթում
(առավելագույնից նվազագույն); Otaq temperaturunda saxlayın.
Maksimum və minimum temperatur aralığında müvəqqəti
yayınmalara icazə verilir; Храните при комнатной температуре.
Допускаются временные отклонения интервала температур
(макс.-мин.); Simpan pada suhu ruang. Deviasi sementara dalam
rentang suhu (maks-min) diizinkan; Simpan pada suhu bilik. Peny-
impangan sementara dalam julat suhu (maks-min) adalah dibenar-
kan: 室温で保管。温度範囲（最大～最小）内の温度逸脱は許
容。; 실온에서 보관하십시오. 온도 범위내에서의 일시적인 편
차(최대-최소)는 허용됩니다; 室溫儲存。允許在溫度範圍內
（上限至下限）的溫度差異。; 室温下存放。允许温度范围内
（最高-最低）的暂时偏差。;
חווט ךותב תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי חווט ךותב תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי
.(םומינימ-םומיסקמ) הרוטרפמטה.(םומינימ-םומיסקמ) הרוטרפמטה
       .     
.( - )
Caution, consult instructions for use; Vorsicht, Gebrauchsan-
weisung beachten; Let op: Raadpleeg de gebruiksaanwijzingen;
Mise en garde, consulter le mode d’emploi; Attenzione, consultare
le istruzioni per l’uso; Precaución, consultar instrucciones de uso;
Cuidado, consultar as instruções de utilização; Varning, läs instruk-
tion; Forsigtig, se brugsanvisning; Forsiktig, se bruksanvisningen;
Varoitus, katso käyttöohjeet; Varúð, lesið notkunarleiðbeiningarnar;
Ettevaatust, tutvuge kasutusjuhendiga; Uzmanību! Izlasiet lietošanas
norādījumus; Dėmesio, skaityti naudojimo instrukciją; Upozornění,
viz návod k použití; Figyelem, tájékozódjon a használati útmu

11
שומישה תוארוהב ןייעל שי ,תוריהז; שומישה תוארוהב ןייעל שי ,תוריהז;    
Medical Device; Medizinprodukt Medisch hulpmiddel; Dispositif
médical; Dispositivo medico; Producto sanitario; Dispositivo médi-
co; Medicinteknisk produkt; Medicinsk udstyr; Medisinsk utstyr;
Lääkinnällinen laite; Lækningatæki; Meditsiiniseade; Medicīniska
ierīce; Medicinos priemonė; Zdravotnický prostředek; Orvostechni-
kai eszköz; Zdravotnícka pomôcka; Medicinski pripomoček; Wyrób
medyczny; Dispozitiv medical; Medicinski proizvod; Медицинско
средство; Іατροτεχνολογικό προϊόν; Медицинскоизделие; Tıbbi
cihaz; სამედიცინო მოწყობილობა; Բժշկական սարք; Tibbi
Avadanlıq; Медицинское изделие; Peralatan Medis; Peranti Peru-
batan; 医療機器; 의료 장치; 醫療裝置; 医疗器械;
יאופר ןקתה;יאופר ןקתה;  
MD
tatóból; Pozor, riaďte sa návodom na použitie; Pozor; glejte navodila
za uporabo; Uwaga, należy zapoznać się z instrukcją obsługi;
Atenție! Consultați instrucțiunile de utilizare; Pozor: proučite upute
za upotrebu; Oprez, konsultovati uputstvo za upotrebu; Προσοχή,
συμβουλευτείτε τις οδηγίες χρήσης; Внимание, консултирайте се
с инструкциите за употреба; Dikkat, kullanmadan önce talimatları
inceleyin; გაფრთხილება, მოითხოვეთ გამოყენების
ინსტრუქცია; Ուշադրություն, հետևեք օգտագործման
հրահանգներին; Xəbərdarlıq, istifadə qaydalarını oxuyun;
Предостережение, обратитесь к инструкциям по применению;
Perhatian, baca petunjuk penggunaan; Berhati-hati, rujuk arahan
penggunaan; 注意、取扱説明書を参照; 주의, 사용 지침을 참조
하십시오; 注意事項，參閱使用說明; 小心，参阅使用说明书;
IFU
Instructions for use; Gebrauchsanweisung; Gebruiksaanwijzing; Mode
d’emploi; Istruzioni per l’uso; Instrucciones de uso; Instruções de
utilização; Bruksanvisning; Brugsanvisning; Bruksanvisning; Käyt-
töohjeet; Notkunarleiðbeiningar; Kasutusjuhend; Lietošanas norādījumi;
Naudojimo instrukcija; Návod k použití; Használati útmutató; Návod
na použitie; Navodila za uporabo; Instrukcja użycia; Instrucțiuni de
utilizare; Upute za upotrebu; Uputstvo za upotrebu; Οδηγίες χρήσης;
Инструкции за употреба; Kullanım talimatları; გამოყენების
ინსტრუქცია; Օգտագործման հրահանգներ; İstifadə qaydaları;
Инструкции по применению; Petunjuk penggunaan; Arahan peng-
gunaan; 取扱説明書; 사용 지침; 使用說明; 使用说明书;
שומיש תוארוה;שומיש תוארוה;
 

12
Contents
EN - ENGLISH..............................................................13
DE - DEUTSCH ............................................................19
NL - NEDERLANDS....................................................26
FR - FRANÇAIS............................................................34
IT - ITALIANO...............................................................41
ES - ESPAÑOL..............................................................49
PT - PORTUGUÊS.......................................................56
HE - ................................................................................70
AR - .............................................................................76

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Before starting any rehabilitation activity involving the
TheraBite system every user should consider the benets of
medically supervised programs. Clinicians may select and
combine exercises to form programs that are appropriate for
each user’s abilities and goals, including regular monitoring
and review.
ENGLISH
1. Descriptive information
1.1 Intended use
The TheraBite
®
Jaw Motion Rehabilitation System is indicated
for individuals who have, or are at risk of developing trismus
(restrictions in their ability to open their jaw), and/or experience
pain in the joints and/or muscles of the jaw. The device can
also be used as a rehabilitation tool for postoperative physical
therapy of the jaw, or to maintain the mouth open in a stable
position, for example while performing dysphagia exercises.
The TheraBite system is intended for single-patient use only.
1.2 Contraindications
The TheraBite is not intended to 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.
• Individuals with infections of the jaw, osteomyelitis
(inammation of bone and bone marrow), or
osteoradionecrosis (necrosis of bone due to radiation) of
the jaw.
1.3 Description of the device
The TheraBite Jaw Motion Rehabilitation System consists
of the following parts:
1 pc Jaw Mobilizer (Fig. 1)
4 pcs Bite Pads (Fig. 2)
1 pc Hand-Aid (Fig. 3)
30 pcs Range of Motion Scales (Fig. 4)
1 pc Carrying Bag (Fig. 5)
1 pc Instructions for use
1 pc Exercise Log
The Jaw Mobilizer (Fig. 1) is a hand-held device with
adjustable range that is designed to help users to improve or
maintain the range of motion and strength of the jaw in an
anatomically correct way. Pressure applied by the user on
the Lever provides either opening force for passive motion or
stretching or resistance to closing for strengthening.

14
The device consists of the following parts:
a) Fine Adjustment Knob
b) Lever
c) Range Setting Arm
d) Upper Mouthpiece
e) Lower Mouthpiece
CAUTION: Do not attempt to detach the Mouthpieces from
the device; this can cause failure during use.
The Bite Pads (Fig. 2) are self-adhesive pads intended to protect
the user’s teeth. They are available in three versions: Regular,
Edentulous (toothless, thicker cushioning for customized
trimming) and Pediatric. Clinicians may, according to their
independent medical judgment, stack or trim the Bite Pads
for extra protection
The Hand-Aid (Fig. 3) is a tool designed to hold the Lever
down and maintain opening during stretching exercises.
The Range of Motion Scale (Fig. 4) is used to monitor the
progress of the rehabilitation program. An area to record your
progress is printed on the reverse side of the scale and an
Exercise Log comes with your device to track your progress.
The Range of Motion Scale is a disposable product and should
not be cleaned.
1.4 Expectations of the device
Passive motion and stretching with the TheraBite
• is effective in the reduction of trismus resulting from
radiation and/or scarring in head and neck cancer patients.
• is effective in the prevention of trismus in patients
undergoing (chemo)radiation.
• can help to improve joint and jaw function, improve range of
motion, and reduce pain in patients with temporomandibular
disorders.
• has a positive effect on the outcome of surgery when used
for early mobilization in patients who have undergone
tempomandibular joint surgery.
The TheraBite can also strengthen the jaw muscles when
resistance to closing is provided by hand or with the ActiveBand.
During ‘Open Swallow Exercise’ the TheraBite can be used
to hold the mouth open in a stable position.
NOTE:Prospective users should consult with their clinician
before use to determine whether the TheraBite is appropriate
for their individual condition.
1.5 WARNINGS
• DO NOT continue to exercise if you feel unexpected
pain at any time while exercising with the TheraBite. You
should immediately stop using the device and contact your
clinician.
• DO exercise with great caution if you have weakened teeth,
gum disease, weakened bones or joints in jaw, dental plates,
crowns or bridges. Injury may occur if excessive force is
applied while using the TheraBite.

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1.6 PRECAUTIONS
• Do not sterilize the TheraBite. Sterilization processes may
weaken the TheraBite and it may break during use.
• Always handle the TheraBite with care; it may break during
use if damaged due to rough handling.
• Do not apply too high force on the Mouthpieces. They are
designed to break if too much force is applied during use in
order to avoid injury to the jaw.
2. Instructions for use
Before the rst use, the maximum opening of the TheraBite
appropriate for each individual user should be determined by
the clinician.
2.1 Preparation
Setting Maximum Opening of the Jaw Mobilizer
Maximum openings of approximately 25 to 45 millimeters
can be set either by the position of the Range Setting Arm or
the position of the Fine Adjustment Knob. The TheraBite can
be used without adjusting these settings, depending on the
user’s ability to understand and implement instructions for
the application of appropriate pressure.
Adjust the Range Setting Arm (Fig. 6-7)
• Hold the device on its side.
• Use a pointed object (such as a pen) to move the pin that
connects the Range Setting Arm to the Lever (Fig. 7a & 7b).
• Align the Range Setting Arm in the desired position and
replace the pin. (Range change is approximately 5 mm per
interval.)
The scale on the Jaw Mobilizer is for reference only. Use the
Range of Motion Scale for more accurate reference.
2.2 Operating instruction
Before each use check that the device is undamaged. Do not
use the device if it is damaged.
Put on the Bite Pads (Fig. 8-9)
Always make sure that the Mouthpieces are completely dry
before attaching the Bite Pads.
• Peel off the liner (Fig. 8).
• Attach one Bite Pad to the Upper Mouthpiece and one to
the Lower Mouthpiece (Fig. 9).
• Apply pressure with your ngers to ensure proper adhesion
to the Mouthpieces. Pressure and warmth under a prolonged
period will make the Bite Pads stick better.
To enhance adhesion of the Bite Pads, attach the Bite Pads to the
Mouthpieces before going to bed and leave them on overnight.
The adhesive bond on the Bite Pads increases over time, the
longer they are attached prior to use, the more strongly they
will tend to adhere.
Replace the Bite Pads when they become worn. Additional
Bite Pads can be ordered separately.

16
CAUTION: Bite Pads or parts of the pads that become
loose during use might obstruct breathing. Always make sure
that the Bite Pads are securely attached to the Mouthpieces.
Use the Fine Adjustment Knob (Fig. 10)
The Fine Adjustment Knob can be used to slow down or stop
the motion created by the Jaw Mobilizer. If the Knob should
break for any reason, a new one can be ordered separately.
• Turn the knob all the way in (counterclockwise) to stop the
Lever in the highest position (Fig. 10a).
• While squeezing gently, turn the knob out (clockwise)
to allow the Lower Mouthpiece to move down slowly
(Fig. 10b).
• The Lever may be released at any time without turning the
Fine Adjustment Knob.
Use the Hand-Aid (Fig. 11)
• 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. 11a).
• 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. 11b).
To measure the maximal mouth opening (Maximal
Interincisal Opening) (Fig. 12)
• 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 front tooth.
• Rotate the range of motion scale until it contacts an upper
front tooth.
• Take the reading at the point of contact.
In edentulous users, the distance can be measured between
the upper and lower dentures, or if the user is not wearing
dentures between the upper and lower alveolar ridges (gums).
To measure Lateral Movement (Fig. 13)
• Rest the Range of Motion Scale against the chin with the
upper and lower teeth gently closed together.
• Align the arrow with a space between two upper teeth
(Fig. 13a).
• Move the jaw gently side-to-side and read the measurement
on the Lateral Scale opposite the new position of the space
(Fig. 13b & 13c).
2.3 Exercise programs
It is recommended that your clinician selects and combines
exercises that are appropriate for you, including regular
monitoring and review.

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A commonly used exercise program is 5-5-30: Five times per
day. Five stretches each time. Each stretch held for 30 seconds.
When short stretches are deemed sufcient a common exercise
program used is 7-7-7: Seven times per day. Seven stretches
each time. Each stretch held for seven seconds.
Stretching/passive motion
• 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 place the Mouthpieces between your teeth. Your
front teeth should just touch the inside rim of the Upper
Mouthpiece (Fig. 14a).
• Slowly squeeze the Lever to open the Mouthpieces. Do not
bite on the Mouthpieces (Fig. 14b).
• 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 the Lever. Tilting may cause your jaw
to move incorrectly.
• Hold open as long as instructed.
• Relax the squeeze, allowing your mouth to slowly close
(Fig. 14c).
If you nd it difcult to hold the Mouthpieces open, you may
use the Hand-Aid.
Strengthening
• Insert the Mouthpieces and squeeze until you reach the
opening as instructed.
• Bite against the Mouthpieces without releasing the Lever.
• 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, and repeat.
For strengthening exercises using the TheraBite ActiveBand,
see the TheraBite ActiveBand instructions for use.
2.4 Use of Exercise Log
Use the Range of Motion Scale to size your mouth opening
before and after each exercise. The exercise log is used to
document and monitor your progress. The columns in the log
are for the following data:
Section 1: Daily Exercise Log
A: Date
B: Time
C: Type of exercise program/day
D: Sizing of jaw opening
1) Before; 2) After the exercise program.
Section 2: Monthly Exercise Log
The X-axis displays the day of the month. Use the last sizing of
the day from the Daily Exercise Log and enter on the Y-axis.

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2.5 Cleaning
Use water and dish soap to clean the TheraBite Jaw Mobilizer
and Hand-Aid. Rinse well, shake off excess water, and let
dry. After cleaning, examine the Bite Pads and replace them
if necessary.
NOTE: The Mouthpieces are made of a material that tends
to retain moisture. Therefore make sure that the Mouthpieces
are completely dry before replacing the Bite Pads and also
before use.
Do not soak the TheraBite Jaw Mobilizer in any liquid or
attempt to wash it in a dish washer.
Failure to follow the above may change the products
properties and result in malfunction.
2.6 Device lifetime
Depending on handling and usage, the device life time varies.
Laboratory testing of simulated daily usage for a test period
of 12 month show that the device will maintain its structural
integrity for this time period. Usage beyond this time is under
the sole discretion of the user.
2.7 Additional devices
TheraBite ActiveBand: an elastic silicone band used together
with the Jaw Mobilizer to increase and / or maintain strength
and endurance of the chewing muscles.
2.8 Disposal
Always follow medical practice and national requirements
regarding biohazards when disposing of a used medical device.
3. Troubleshooting information
A build-up develops on the Mouthpieces
Possible cause: Build-up may be due to collected dirt on
Mouthpieces after long periods of use or incorrect cleaning
methods.
What to do: Use an emery board (nail le) to lightly le the
surface of the Mouthpieces and rinse off the residue completely.
Dry the Mouthpieces and apply new Bite Pads. Follow cleaning
instructions.
Bite Pads do not stick properly to Mouthpieces
Possible cause: Bite Pads may not stick properly if the
Mouthpieces contain moisture or if the Bite Pads were not
properly placed on the Mouthpieces.
What to do: Always make sure the Mouthpieces are completely
dry and free of build-up before applying the Bite Pads. Apply
sufcient pressure to ensure good initial adhesion to the
Mouthpieces. Allow the adhesive to bond overnight if possible
before use.

19
4. Additional information
4.1 User assistance information
For additional help or information please see back cover of
this instructions for use for contact information.
5. Reporting
Please note that any serious incident that has occurred in
relation to the device shall be reported to the manufacturer
and the national authority of the country in which the user
and/or patient resides.
Ehe mit Rehabilitationsmaßnahmen mit dem TheraBite-System
begonnen wird, sollte jeder Anwender über die Vorteile eines
ärztlich überwachten Programms nachdenken. Um Programme
zu erstellen, kann ein Arzt Übungen auswählen und miteinander
kombinieren, die den Fähigkeiten und Zielen eines jeden
Anwenders angemessen sind.
DEUTSCH
1. Beschreibende Informationen
1.1 Verwendungszweck
Das “TheraBite®Kieferbewegung-Rehabilitationssystem “ ist
für Personen indiziert, die einen Trismus (Einschränkung der
Kieferbeweglichkeit) entwickelt haben oder bei denen die Gefahr
eines solchen besteht und/oder die Schmerzen in den Gelenken
und/oder Muskeln des Kiefers verspüren. Das Instrument
kann zudem als Werkzeug zur Rehabilitation im Rahmen der
postoperativen Physiotherapie des Kiefers verwendet werden.
Es kann außerdem dazu dienen, den Mund in einer stabilen
Stellung offen zu halten, z. B. während Übungen zur Therapie
von Schluckstörungen durchgeführt werden.
Das TheraBite-System ist für die Anwendung durch einen
einzigen Patienten gedacht.
1.2 Kontraindikationen
Das TheraBite ist nicht für den Gebrauch indiziert:
• durch Personen, die einen Bruch im Ober- oder Unterkiefer
haben oder bei denen der Verdacht auf einen Bruch besteht
oder im Fall von sonstiger Knochenschwäche im Kiefer.
• durchPersonenmit einerInfektiondes Kiefers,Osteomyelitis
(Entzündung des Knochens und Knochenmarks) oder
Osteoradionekrose (Nekrose des Knochens infolge von
Bestrahlung) des Kiefers.

20
1.3 Beschreibung des Instruments
Das TheraBite Kieferbewegung-Rehabilitationssystem
setzt sich aus den folgenden Teilen zusammen:
1 Stck. Kiefermobilisator (Abb. 1)
4 Stck. Bite Pads (Bisspolster) (Abb. 2)
1 Stck. Hand-Aid (Arretierscheibe) (Abb. 3)
30 Stck. Range of Motion Scales (Messhilfe für die maximale
Kieferöffnung) (Abb. 4)
1 Stck. Carrying Bag (Tragetasche) (Abb. 5)
1 Stck. Bedienungsanleitung
1 Stck. Übungsprotokoll
Beim Kiefermobilisator (Abb. 1) handelt es sich um ein
Handinstrument mit verstellbarem Bereich, das dafür gedacht
ist, dem Anwender dabei zu helfen, dessen Beweglichkeit und
Muskelkraft des Kiefers auf anatomisch korrekte Art und
Weise zu erhöhen oder zu erhalten. Der vom Anwender auf
den Hebel ausgeübte Druck sorgt entweder für Öffnungskraft
bei passiven Bewegungsübungen oder für Dehnkraft oder
Schließwiderstand bei Kraftübungen.
Das Instrument setzt sich aus den folgenden Teilen
zusammen:
a) Rädchen für die Feineinstellung
b) Hebel
c) Range Setting Arm (Bereich-Einstellarm)
d) Oberes Mundstück
e) Unteres Mundstück
VORSICHT: Versuchen Sie nicht, die Mundstücke vom
Instrument zu lösen; dies kann während des Gebrauchs zum
Versagen desselben führen.
Bei den Bisspolstern (Abb. 2) handelt es sich um selbsthaftende
Pads, mit denen die Zähne des Anwenders geschützt werden
sollen. Sie sind in drei Versionen erhältlich: Regular (Normal),
Edentulous (Zahnlos) (stärkere Polsterung, die der Anwender
nach Bedarf zuschneiden kann) und Pediatric (Für Kinder). Ärzte
können die Bisspolster nach ihrem unabhängigen medizinischen
Ermessen für zusätzlichen Schutz aufeinanderstapeln oder
zuschneiden.
Bei der Arretierscheibe (Abb. 3) handelt es sich um ein
Werkzeug, mit dem der Hebel nach unten gedrückt gehalten und
so bei Dehnübungen für eine dauerhafte Öffnung gesorgt wird.
Die Messhilfe für die maximale Kieferöffnung (Abb. 4)
dient zur Überwachung des Fortschritts im Rahmen des
Rehabilitationsprogramms. Auf der Rückseite der Skala ist ein
Bereich aufgedruckt, in dem Sie Ihren Fortschritt aufzeichnen
können. Ihrem Instrument liegt außerdem ein Übungsprotokoll
bei, mit dem Sie Ihren Fortschritt ebenfalls festhalten können.
Bei der Messhilfe für die maximale Kieferöffnung handelt es
sich um ein Einwegprodukt, das nicht gereinigt werden sollte.