Orthofix CERVICAL STIM 5505CE Instruction Manual Download Page 2 | Manualshive

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CervicalStim Device Patent No.
U.S. 6,024,691
U.S. 5,743,844
U.S. 6,132,362

Assembled in the United States of America

ASSEMBLED IN

USA

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Summary of Contents for CERVICAL STIM 5505CE

Page 1: ...Model 5505CE Instruction Manual...

Page 2: ...CervicalStim Device Patent No U S 6 024 691 U S 5 743 844 U S 6 132 362 Assembled in the United States of America ASSEMBLED IN USA...

Page 3: ...f Treatment Instructions Timing of Treatment Sessions Charging the Battery Visual and Audio Indicators Wearing the Device Device Use and Care Care and Cleaning Storage Travel Disposal Service Clinical...

Page 4: ...our doctor has given you If you use CervicalStim incorrectly it may harm you or may not help your healing process CervicalStim has not been evaluated in treating patients with the following conditions...

Page 5: ...y s natural healing process that may be impaired in some people CervicalStim contains a Control Unit and a Treatment Coil in one integrated device A micro processor generates CervicalStim s electrical...

Page 6: ...the treatment status and the compliance percentage The LCD will show the prescribed treatment time remaining and the battery status The flashing colon on the LCD screen and On Off button indicate tha...

Page 7: ...atment is complete The LCD shows a countdown of the daily treatment time remaining To stop treatment at any point simply press and hold the On Off Button until you hear a beep To resume treatment pres...

Page 8: ...he AC Wall Outlet is delivering power 5 The Control Unit LCD will display a battery symbol filling to verify that the device is charging When the battery reaches a complete charge a check mark symbol...

Page 9: ...Charging Complete Charging Complete Indicates when the battery is fully charged Battery must be charged to turn on E12345678 E12345678 Battery Empty Indicates that the battery must be charged before...

Page 10: ...n gently bend and shape the treatment coil to fit more comfortably around the neck The following is the suggested method for wearing CervicalStim 1 To put on CervicalStim simply slip the device over y...

Page 11: ...Do not modify this equipment as this could make it unsafe to use Do not attempt to open or disassemble CervicalStim as there are no user serviceable parts inside CAUTION STRANGULATION HAZARD Keep the...

Page 12: ...erate CervicalStim while onboard the airplane Disposal After treatment is complete and a physician advises you to discontinue use you may dispose of the device according to your local governing ordina...

Page 13: ...gned to the control group and 163 patients were assigned to the CervicalStim group Patients wore the CervicalStim unit for 4 hours each day either for 4 continuous hours or in one hour sessions Safety...

Page 14: ...include increased pain numbness and tingling headache migraines and nausea These effects may or may not be directly related to the use of the CervicalStim Clinical success with regard to symptoms was...

Page 15: ...0 0 0 1 1 5 1 1 5 1 1 5 2 3 0 1 1 5 1 1 5 1 1 5 1 1 5 67 1 of Patients Experiencing the Event 9 5 6 9 5 6 8 5 0 3 1 9 2 1 3 8 5 0 2 1 3 6 3 8 2 1 3 2 1 3 0 2 1 3 0 0 0 0 1 0 6 0 0 0 0 0 1 0 6 1 0 6 1...

Page 16: ...ufacture for Active Device Device and Device Box Manufacturer Instruction Manual Not for General Waste Device and Device Box Keep Dry Device and Device Box FCC Mark Device and Device Box CE Mark Devic...

Page 17: ...the 1Hz 50KHz range This field is distributed within and near the treatment coil Type BF applied part The applied part is the treatment coil with integrated control unit IEC 60529 enclosure rating IP...

Page 18: ...garding Electromagnetic Compatibility and Immunity CervicalStim complies with IEC 60601 1 2 for electromagnetic compatibility EMC CervicalStim needs special precautions regarding EMC and needs to be u...

Page 19: ...Representative or your local distributor to obtain the Return Authorization number and address prior to returning the product Except as specifically required by applicable law the foregoing warranty...

Page 20: ......

Page 21: ...Mod le 5505CE Manuel d instructions French Fran ais...

Page 22: ...N de brevet du dispositif CervicalStim U S 6 024 691 U S 5 743 844 U S 6 132 362 Assembl aux tats Unis ASSEMBLED IN USA...

Page 23: ...i des s ances de traitement Charge de la batterie Indicateurs visuels et sonores Application du dispositif Utilisation et entretien du dispositif Entretien et nettoyage Stockage Transport limination R...

Page 24: ...du m decin viter d utiliser le dispositif CervicalStim Si le dispositif CervicalStim est utilis de fa on incorrecte cela risque de porter atteinte au patient ou de ne pas avoir d effet sur le processu...

Page 25: ...peut tre diminu chez certaines personnes Le CervicalStim comprend une unit de commande et un transducteur de traitement en un seul dispositif Un microprocesseur g n re le signal lectrique du dispositi...

Page 26: ...LCD indique le temps restant pour le traitement prescrit et l tat de la batterie Le deux points qui clignote sur l cran LCD et le bouton marche arr t indiquent que le dispositif est en marche et que l...

Page 27: ...CD indique un compte rebours de la dur e de traitement quotidienne restante Pour arr ter tout moment le traitement il suffit d appuyer sur le bouton marche arr t et de le maintenir enfonc jusqu ce qu...

Page 28: ...eur murale est sous tension 5 L cran LCD de l unit de commande affiche un symbole de batterie qui se remplit pour confirmer la charge du dispositif Quand la batterie est compl tement charg e un symbol...

Page 29: ...quand la batterie est compl tement charg e La batterie doit tre charg e pour pouvoir mettre le dispositif en marche E12345678 E12345678 Batterie puis e Indique que la batterie doit tre charg e avant...

Page 30: ...eut l g rement fl chir et mettre en forme le transducteur de traitement afin d obtenir une meilleure adaptation autour du cou M thode sugg r e pour l application du dispositif CervicalStim 1 Pour appl...

Page 31: ...ce mat riel cela risque d affecter son innocuit Ne pas tenter d ouvrir ou de d monter le dispositif CervicalStim il ne contient aucune pi ce r parable par l utilisateur MISE EN GARDE RISQUE D TRANGLEM...

Page 32: ...ent est termin et qu un m decin prescrit l arr t du traitement le dispositif peut tre limin conform ment aux ordonnances gouvernementales ou programmes de recyclage locaux Contacter les autorit s loca...

Page 33: ...s ont t affect s au groupe CervicalStim Les patients ont port le dispositif CervicalStim pendant 4 heures chaque jour 4 heures successives ou 4 s ances d une heure La s curit et l efficacit ont t valu...

Page 34: ...ents c phal es migraines et naus e Ces effets peuvent tre directement li s ou non l utilisation du dispositif CervicalStim La r ussite clinique en termes de sympt mes a t valu e selon les crit res sui...

Page 35: ...8 8 4 9 Complications chirurgicales 2 3 0 2 1 3 7 7 7 5 3 1 Lombalgie 8 11 9 8 5 0 5 5 5 5 3 1 Traumatisme l sion non cervical 2 3 0 2 1 3 5 5 5 4 2 5 Engourdissement picotements 6 8 9 6 3 8 4 4 4 4...

Page 36: ...e de fabrication dispositif actif Dispositif et bo te du dispositif Fabricant Mode d emploi Ne pas liminer avec les d chets m nagers Dispositif et bo te du dispositif Conserver au sec Dispositif et bo...

Page 37: ...fonctionnement Fonctionnement intermittent Ce dispositif n est pas st rile Il n a pas besoin d tre st rilis Dur e de vie du mat riel 1 an Ce mat riel ne doit pas tre utilis en pr sence d un m lange d...

Page 38: ...im est conforme la norme IEC 60601 1 2 remative la compatibilit lectromagn tique CEM Le dispositif CervicalStim exige des pr cautions particuli res en mati res de CEM et doit tre utilis conform ment a...

Page 39: ...peler un repr sentant des Services patient ou le distributeur local pour obtenir un num ro de retour et une adresse avant de renvoyer le produit Sauf dans la mesure sp cifiquement exig e par la loi en...

Page 40: ...lia 1 800 870 395 Australian Sponsor Emergo Australia Level 20 Tower II Darling Park 201 Sussex Street Sydney NSW 2000 Australia orthofix com bonestimulation com P N 20122316 Rev AC 2017 08 22 CS 1703...

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