Orthofix Cervical-Stim 5505 Instruction Manual Download Page 7

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Treatment Instructions

•  The CervicalStim device should be worn for 4 hours each day as prescribed 

by a physician.   

•  The CervicalStim device may be used at any time of day that is most 

convenient for the patient.

•  The device is programmed to reset daily at midnight Central Standard Time, 

unless adjusted by a physician or Orthofix representative for a  
different time zone or reset time. 

•  Hours worn before the reset time will be logged and stored in the device for 

daily use compliance.

•  The overall treatment duration (months/weeks) will vary based on  

specific patient conditions as determined by a physician.

•  Because the CervicalStim device is lightweight and portable, treatment can 

be received while sitting, walking, reclining, sleeping, etc. However, since 
each patient is unique, the overall activity level should be based on  
physician instructions.

Timing of Treatment Sessions

•  The CervicalStim device tracks the treatment time; this tracking (or timing)  

begins when the device is turned on and at least one minute of treatment 
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, press the On/Off button again. 
• The countdown will resume at the remaining daily treatment time. 
•  When daily treatment is completed, the device will automatically  

turn off.

Charging the Battery

The CervicalStim device is powered by a rechargeable lithium-ion battery pack. 

The battery pack will provide at least one full treatment before needing to be 

recharged. A power supply to charge the battery is provided with the device. 

Use only the Orthofix power supply to charge the battery (Part no. Orthofix 

20110412, 20114794, WR9QA1200U23KIT(R6B), or 20123808). 

To ensure that the device is functioning properly, the CervicalStim device 

constantly monitors battery voltage and the electrical signal. The LCD will display 

a battery capacity symbol and the device will beep to alert the patient when  

the battery is low and will soon need to be recharged.  

The CervicalStim device should be charged before the first use and every day 

after completing treatment. Do not wear the device while charging. The device 

will not deliver treatment while charging.

Summary of Contents for Cervical-Stim 5505

Page 1: ...Model 5505 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: ...Visual and Audio Indicators Wearing the Device Device Accessories Device Use and Care Care and Cleaning Storage Travel Disposal Service Clinical Information Clinical Data Summary Adverse Events Equip...

Page 4: ...alStim device incorrectly it may harm you or may not help your healing process The CervicalStim device has not been evaluated in treating patients with the following conditions osseous or ligamentous...

Page 5: ...atural healing process that may be impaired in some people The CervicalStim device contains a Control Unit and a Treatment Coil in one integrated device A micro processor generates the CervicalStim de...

Page 6: ...ow the prescribed treatment time remaining and the battery status The flashing colon on the LCD screen and On Off button indicate that the device is on and delivering treatment The CervicalStim device...

Page 7: ...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 press the On...

Page 8: ...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 will be displayed next to the battery symbo...

Page 9: ...lete 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 treatment may...

Page 10: ...icalStim device simply slip the device over your head 2 For a wider opening detach the Velcro Tab near the control unit and place over your head 3 The device does not need to be tight against the back...

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

Page 12: ...y personnel Do not wear or operate the CervicalStim device while onboard the airplane Disposal After treatment is complete and a physician advises you to discontinue use you may dispose of the device...

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

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

Page 15: ...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 0 6...

Page 16: ...ive 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 Device and Device Box...

Page 17: ...12 Orthofix 20114794 Input 100 240VAC 50 60Hz 200mA Input 100 240VAC 50 60Hz 150 350mA Output Voltage 5VDC 1 3A Output Voltage 5VDC 2 4A Orthofix 20123808 Orthofix WR9QA1200U23KIT R6B Input 100 240VAC...

Page 18: ...bility and Immunity The CervicalStim device complies with IEC 60601 1 2 for electromagnetic compatibility EMC The CervicalStim device needs special precautions regarding EMC and needs to be used in ac...

Page 19: ...ces 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 warran...

Page 20: ......

Page 21: ...Modelo 5505 Manual De Instrucciones Spanish Espa ol...

Page 22: ...CervicalStim patente de dispositivo n U S 6 024 691 U S 5 743 844 U S 6 132 362 Ensamblado en los Estados Unidos de Am rica ASSEMBLED IN USA...

Page 23: ...siones de tratamiento Carga de la bater a Indicadores visuales y audibles Transporte del dispositivo Accesorios del dispositivo Utilizaci n y cuidado del dispositivo Cuidado y limpieza Almacenamiento...

Page 24: ...ecta este podr a causarle lesiones o no ayudarle en su proceso de curaci n El dispositivo CervicalStim no se ha evaluado en el tratamiento de pacientes con las siguientes enfermedades traumatismo espi...

Page 25: ...star afectado en algunas personas El dispositivo CervicalStim incluye una unidad de control y un transductor de tratamiento en un dispositivo integrado Un microprocesador genera la se al el ctrica del...

Page 26: ...estante y el estado de la bater a Los dos puntos parpadeantes de la pantalla LCD y del bot n de Encendido Apagado indican que el dispositivo est encendido y aplicando el tratamiento El dispositivo Cer...

Page 27: ...tratamiento La LCD muestra una cuenta regresiva del tiempo restante de tratamiento diario Para detener el tratamiento en cualquier momento solo tiene que mantener oprimido el bot n de Encendido Apagad...

Page 28: ...trar un s mbolo de una bater a llen ndose para verificar que el dispositivo se est cargando Cuando la bater a alcance la carga completa se mostrar un s mbolo de marca de comprobaci n junto al s mbolo...

Page 29: ...Carga completa indica cuando la bater a est completamente cargada La bater a debe estar cargada para encender el dispositivo E12345678 E12345678 Bater a vac a indica que la bater a debe cargarse ante...

Page 30: ...o CervicalStim solo tiene que colocarse el dispositivo por encima de la cabeza 2 Para una mayor abertura desprenda la pesta a de Velcro situada cerca de la unidad de control y col quesela por encima d...

Page 31: ...so podr a dejar de ser seguro No intente abrir ni desarmar el dispositivo CervicalStim ya que no contiene ninguna pieza que el usuario pueda reparar PRECAUCI N PELIGRO DE ESTRANGULAMIENTO mantenga el...

Page 32: ...CervicalStim a bordo del avi n Eliminaci n Una vez que complete el tratamiento y un m dico le indique que deje de usarlo deber desechar el dispositivo de acuerdo con las ordenanzas o planes de recicla...

Page 33: ...ntrol y 163 pacientes al grupo del dispositivo CervicalStim Los pacientes llevaron puesto el dispositivo CervicalStim durante 4 horas al d a en sesiones de 4 horas continuas o de una hora La seguridad...

Page 34: ...dolor de cabeza migra as y n useas Estos efectos podr an estar o no directamente relacionados con el uso del dispositivo CervicalStim El xito cl nico con respecto a los s ntomas se evalu mediante lo s...

Page 35: ...9 5 5 Patolog a de nivel adyacente 3 4 5 3 1 9 8 8 8 8 4 9 Complicaciones quir rgicas 2 3 0 2 1 3 7 7 7 5 3 1 DEB patolog a lumbar 8 11 9 8 5 0 5 5 5 5 3 1 Traumatismo o lesi n no cervical 2 3 0 2 1 3...

Page 36: ...ositivo Fabricante Manual de instrucciones No debe desecharse en la basura general Dispositivo y caja del dispositivo Mant ngase seco Dispositivo y caja del dispositivo Marca FCC Dispositivo y caja de...

Page 37: ...1 a o El equipo no debe utilizarse en presencia de una mezcla anest sica inflamable con aire u xido nitroso La fuente de alimentaci n se considera doblemente aislada con una construcci n clase II en...

Page 38: ...re el equipo y el receptor Conecte el equipo a un tomacorriente de un circuito diferente al circuito donde est conectado el receptor Consulte al proveedor o a un t cnico de radio TV con experiencia pa...

Page 39: ...sentante de Atenci n a pacientes o a su distribuidor local para obtener el n mero de autorizaci n de la devoluci n y la direcci n antes de devolver el producto Excepto que las leyes correspondientes l...

Page 40: ...056 Tel 214 937 2718 Patient Services 800 535 4492 toll free orthofix com BoneGrowthTherapy com P N 20115188 Rev AD 2018 09 05 CS 1804 PL US Orthofix Holdings Inc Caution Federal law USA restricts thi...

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