Orthofix 1114RC R Subject Manual

Rotator cuff repair study

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Subject Manual For the
Orthofix Rotator Cuff Repair Study
Models 1114RC R/L

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Summary of Contents for Orthofix 1114RC R

  • Page 1 Subject Manual For the Orthofix Rotator Cuff Repair Study Models 1114RC R/L...
  • Page 2 ASSEMBLED IN Assembled in the United States of America Device Patents No. U.S. 5,743,844 U.S. 6,132,362...
  • Page 3: Table Of Contents

    Known and Expected Adverse Events ............Device Symbol Descriptions ..............The RCStim Device Classifications ............Compliance Statements ................Information regarding Electromagnetic Compatibility and Immunity ..................Device Box Components 1 – The RCStim Device 1 – Power Supply 1 – Literature Pack Orthofix Clinical Helpline: 866-657-7030...
  • Page 4: Rotator Cuff Repair Study

    Rotator Cuff Repair Study Thank you for participating in the Orthofix Rotator Cuff Repair Study. This study is being conducted to determine if the RCStim device can improve the healing of medium to full thickness tear rotator cuff injuries after muscle repair.
  • Page 5: Device Information

    Device Information The RCStim device is being evaluated an adjunctive therapy for the healing of the rotator cuff muscles following rotator cuff repair surgery. Device Description The RCStim device is an external device that generates a Pulsed Electromagnetic Field (PEMF) signal as a nonsurgical, prescription treatment to increase the chances of a successful rotator cuff repair.
  • Page 6: How The Rcstim Device Works

    How the RCStim Device Works To enhance rotator cuff repair, PEMF therapy activates and augments the body’s natural healing process. The RCStim device contains a Control Unit and a Treatment Coil in one integrated device. A micro-processor generates the PEMF signal, which is a highly uniform, low-energy pulsed electromagnetic field sent from the treatment coil.
  • Page 7: Device Operation

    Device Operation Turning the Device On and Off The RCStim device can be turned on by pressing the On/Off Button on the Control Unit of the device. When the device is turned on, it will display the Compliance Screen with Compliance percentage. The LCD will then show the Treatment Screen with the prescribed treatment time remaining and the battery status.
  • Page 8: Daily Treatment Instruction

    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 that came with the device to charge the RCStim device (Part no. Orthofix 20110412 or 20114794).
  • Page 9 To ensure that the device is functioning properly, the RCStim device constantly monitors battery voltage and the electrical signal. The LCD will display a battery capacity symbol and the device will beep to alert you when the battery is low and will soon need to be recharged.
  • Page 10: Visual And Audio Indicators

    Exception Screen E123 Exception Codes – Display of ERROR, any E codes (e.g., E01, E02), along with three slow beeps. Contact the Orthofix Clinical Helpline at 1-866-657-7030 for help. 1-866-657-7030...
  • Page 11: Device Compliance

    Device Compliance This device works with an app that can be downloaded from the iTunes App store on your iPhone or iPad; it is free of charge. With this app, you will be able to monitor how long you have worn your device every day and whether or not you are being “compliant”...
  • Page 12: Storage Of The Device

    DO NOT dispose of this device. At the end of your prescribed treatment period in the study, please bring the RCStim device with you to your study appointment and they will send it back to the study sponsor (Orthofix) for you.
  • Page 13: Service

    Service If you have questions concerning the device or require any assistance, please call the Clinical Study Helpline at 1-866-657-7030. There are no serviceable parts in this device. Contraindications There are no known contraindications for the RCStim device as an adjunct to rotator cuff repair surgery.
  • Page 14: Adverse Effects Summary

    Known and Expected Adverse Events Adverse effects may be experienced when using the RCStim device. These adverse effects may include increased pain, numbness and tingling, headache, migraines, and nausea. These effects may or may not be directly related to use of the RCStim device.
  • Page 15: Device Symbol Descriptions

    Equipment Classification Device Symbol Descriptions Symbol Meaning Symbol Location Attention – Refer to Instruction Manual Device and Device Box Type BF Applied Part Device and Device Box Read Instructions for Use On/Off Device Prescription Only Device Storage Temperature Range Device Box Year of Manufacture for Active Device Device and Device Box Manufacturer...
  • Page 16: The Rcstim Device Classifications

    (2) this device must accept any interference received, including interference that may cause undesired operation. IMPORTANT! Changes or modifications not expressly approved by Orthofix, Inc. could void the user’s authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
  • Page 17: Information Regarding Electromagnetic Compatibility And Immunity

    the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
  • Page 18 Caution: Investigational Device Limited by Federal (or United States) law to investigational use. Orthofix Inc. 3451 Plano Parkway Lewisville, Texas 75056 Clinical Helpline 866-657-7030 orthofix.com P/N 20123119 Rev.02 BS-1629 © Orthofix Holdings, Inc. 3/2017...

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1114rc l

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