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DJO Global X4 Instructions For Use Manual

Knee brace
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X 4
K ne e Bra c e
T M
In s t r uc t i ons for U se

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Summary of Contents for DJO Global X4

  • Page 1 K ne e Bra c e In s t r uc t i ons for U se...

  • Page 3: Table Of Contents

    ENVIRONMENTAL CONDITIONS ................3 APPLICATION SET UP AND PAIRING ..............4 BRACE APPLICATION INFORMATION ..............4 CLEANING INSTRUCTIONS ..................7 MATERIAL CONTENTS ....................7 X4 SMART BRACE BATTERY REPLACEMENT ............8 FCC AND IC STATEMENTS ..................10 ELECTROMAGNETIC COMPATIBILITY (EMC) .............12 TECHNICAL SPECIFICATIONS .................16 WARRANTY ........................17 DISPOSAL ........................17...

  • Page 4: Intended User Profile

    The Motion Intelligence platform together with X4 is intended to be used to measure and evaluate knee joint range of motion during rehabilitation and exercise in the pre-operative and post-operative phases of reconstructive knee surgery.

  • Page 5: Symbols

    S Y M B O L S S Y M B O L S WARNING! Read and understand all warnings Manufacturer and Instructions for Use before using this device. Non-ionizing Temperature range electromagnetic radiation Atmospheric pressure Humidity range range Indication for protection against water and Prescription only (USA) particular matter...

  • Page 6: Application Set Up And Pairing

    A P P L I C A T I O N S E T U P A N D P A I R I N G A P P L I C A T I O N S E T U P A N D P A I R I N G Download Motion Intelligence App from the App store.
  • Page 7 E N V I R O N M E N T A L C O N D I T I O N S 2. Wrap on thigh strap and secure. Clinician may trim excess material as needed. (Figure 2a and 2b) Figure 2a Figure 2b Wrap on calf strap and secure.
  • Page 8 E N V I R O N M E N T A L C O N D I T I O N S 4. Secure the opposite hinge on the medial or inside of the knee at the center of the knee joint. (Figure 4a and 4b) Figure 4a Figure 4b Stand and walk, make adjustments to straps as needed to ensure hinges...

  • Page 9: Cleaning Instructions

    C L E A N I N G I N S T R U C T I O N S If you are having any medical issues or need an urgent response, please call your doctor’s office directly. If assistance is needed with the brace or setting up or using the App, please call or email: Phone: (844)279-0200/ (760)734-4740 Email: MIsupport@djoglobal.com...

  • Page 10: X4 Smart Brace Battery Replacement

    X 4 S M A R T B R A C E B AT T E RY R E P L A C E M E N T X 4 S M A R T B R A C E B A T T E R Y R E P L A C E M E N T Fully Extend Brace and lay flat with Hinge facing upward.
  • Page 11 X 4 S M A R T B R A C E B AT T E RY R E P L A C E M E N T 4. Lift silicone tray by pulling straight up (metal rod needs to align during reassembly).

  • Page 12: Fcc And Ic Statements

    F C C A N D I C S T A T E M E N T S Replace Hinge cover sliding it over silicone tray. (Figure 12) Figure 12 8. Secure the two screws into hinge cover. (Figure 13) Figure 13 F C C A N D I C S T A T E M E N T S F CC St a t e m e nt s...
  • Page 13 F C C A N D I C S T A T E M E N T S 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 14 Knee Brace MI 360 Sensor is intended for use in the electromagnetic environment specified below. The customer or user of the X4 Knee Brace MI 360 Sensor should assure that it is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions...

  • Page 15: Electromagnetic Compatibility (Emc)

    E L E C T R O M A G N E T I C C O M P AT I B I L I T Y ( E M C ) Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Immunity IEC 60601 Compliance...
  • Page 16 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Portable and mobile RF communications equipment should be used no closer to any part of the X4 Knee Brace Sensor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 17 X4 Knee Brace Sensor is used exceeds the applicable RF compliance level above, the X4 Knee Brace Sensor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the X4 Knee Brace Sensor.

  • Page 18: Technical Specifications

    Knee Brace Sensor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the X4 Knee Brace Sensor can help prevent electromagnetic interference by maintaining a minimum distance between...

  • Page 19: Warranty

    W A R R A N T Y W A R R A N T Y DJO, LLC will repair or replace all or part of the unit and its accessories for material or workmanship defects for a period of six months from the date of sale.
  • Page 20 DJO, LLC 1430 Decision Street Vista, CA T +1.760.727.1280 T +1.800.336.6569 F +1.800.936.6569 DJOglobal.com ©2018 DJO, LLC. All rights reserved. 14-4001 Rev C 2018/04/02...

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