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X-ROM iQ
Instructions For Use

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Summary of Contents for DJO Donjoy X-ROM iQ

  • Page 1 X-ROM iQ Instructions For Use...
  • Page 3: Table Of Contents

    TABLE OF CONTENTS INTENDED USER PROFILE ..............2 INTENDED USE/INDICATIONS ...............2 CONTRAINDICATIONS ................2 WARNINGS AND CAUTIONS ..............2 SYMBOLS ...................... 3 ENVIRONMENTAL CONDITIONS ............3 APPLICATION SET UP AND PAIRING ............4 BRACE APPLICATION INFORMATION ..........5 CLEANING INSTRUCTIONS ..............9 MATERIAL CONTENTS ................9 BATTERY REPLACEMENT ................9 FCC AND IC STATEMENTS ..............
  • Page 4: Intended User Profile

    BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE PROPER FUNCTIONING OF THE DEVICE. INTENDED USER PROFILE The intended user should be a licensed medical professional, the patient, the patient’s caretaker, or a family member providing assistance.
  • Page 5: Symbols

    SYMBOLS WARNING! Read and understand all warnings Manufacturer and Instructions for Use before using this device. Non-ionizing electromagnetic Temperature range radiation Atmospheric pressure Humidity Range range Indication for protection Prescription only (USA). against water and particular matter. ENVIRONMENTAL CONDITIONS Temperatures +41°F (5°C) TO +104°F (40°C) Relative Humidity 15% to 90% non-condensing...
  • Page 6: Application Set Up And Pairing

    APPLICATION SET UP AND PAIRING Download Motion iQ App from the App store. Ensure Bluetooth is enabled on your phone or tablet Settings For iPhone: Settings > Bluetooth > On For Android: Settings > Connections. Bluetooth > On Follow the link in the welcome email from your clinician. This will launch the Motion iQ application and start your account setup.
  • Page 7: Brace Application Information

    BRACE APPLICATION INFORMATION Unfasten strap ends near black buckles and open brace flat by pulling both uprights apart. Place leg on top of flat brace. Shorter upright is applied to the thigh. Adjust brace until each upright is aligned to centerline of the medial and lateral sides of the leg and the center of the hinge is aligned with the center of the knee joint.
  • Page 8 Telescope sliders by depressing the slider button until the desired length is reached. The top and bottom sliders should be adjusted first, followed by the sliders closest to the knee (note that inner sliders cannot be adjusted until the outer sliders are moved to provide sufficient clearance).
  • Page 9 Attach each of the black buckles. Tighten straps by pulling on loose end. Remove excess strap and reposition alligator strap end to new edge of the strap. Secure strap-end to strap. A) Adjust the hinge by pulling the Flexion and Extension stops outward and rotating until the desired angle aligns with the button center.
  • Page 10 STRAP REPLACEMENT: Should straps require replacement, carefully use scissors to cut away the strap where it connects to the slider. Insert the new strap and secure. Contact DJO for the X-ROM iQ Replacement Straps Kit. If you are having any medical issues or need an urgent response, please call your doctor’s office directly.
  • Page 11: Cleaning Instructions

    CLEANING INSTRUCTIONS Remove softgoods from the brace by sliding the straps off the top and bottom of the hinge bars. Hand wash foam liners in water (30°C) with mild detergent. Rinse thoroughly. AIR DRY only, do not heat dry. Do not wash the hinge component containing the electronic sensor.
  • Page 12 Using a fingernail or small object such as a ball point pen, push the gold battery clip to the side and lift up the battery to remove. Place the new battery into the slot towards the gold clip then push the opposite side down until the battery clicks into place.
  • Page 13 Carefully slide the hinge cover back onto the brace and secure by replacing the screws. Be careful to not over tighten the screws.
  • Page 14: Fcc And Ic Statements

    FCC AND IC STATEMENTS FCC Statements Warning: changes or modifications to this device not expressly approved by (DJO LLC) 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 15 IC Statements This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence.
  • Page 16: Electromagnetic Compatibility (Emc)

    ELECTROMAGNETIC COMPATIBILITY (EMC) The X-ROM iQ sensor is intended for use in the electromagnetic environment specified below. The customer or user of the X-ROM iQ sensor should assure that it is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions Electromagnetic Environment Compliance...
  • Page 17 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Immunity IEC 60601 Compliance Environment Test Test Level Level Guidance Floors should be wood, concrete Electrostatic or ceramic tile. If Discharge ±6 kV contact ±8 kV contact floors are covered (ESD) with synthetic ±8 kV air ±15 kV air material, the...
  • Page 18 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Portable and mobile RF communications equipment should be used no closer to any part of the X-ROM iQ sensor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Immunity IEC 60601 Compliance...
  • Page 19 Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 20: Technical Specifications

    TECHNICAL SPECIFICATIONS Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the X-ROM iQ sensor The X-ROM iQ sensor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the X-ROM iQ sensor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the X-ROM iQ sensor as recommended below,...
  • Page 21: Warranty

    WARRANTY 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. To the extent the terms of this warranty are inconsistent with local regulations. The provisions of such local regulations will apply.
  • Page 24 DJO, LLC 1430 Decision Street Vista, CA 92081-8553 • USA T +1.800.321.9549 T +1.800.336.6569 F +1.800.936.6569 DJOglobal.com ©2021 DJO, LLC. All rights reserved. 14-4014 REV B 2021/02/16...

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