ZIBRIO Stability Pro User Manual

ZIBRIO Stability Pro User Manual

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USER MANUAL
ZIBRIO

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Summary of Contents for ZIBRIO Stability Pro

  • Page 1 USER MANUAL ZIBRIO...
  • Page 2: Table Of Contents

    TABLE OF CONTENTS Safety Information ................2 1.1. Limitations ................2 1.2. Care and Use ................. 3 About the Stability Pro scale and ZIBRIO Balance Test ..... 5 2.1. Intended Use ................. 5 2.2. Patient Contact ..............6 What’s in the Box ................
  • Page 3 9.6. Emissions Limits/Group Immunity Test Levels ..... 24 9.7. Resolution & Accuracy ............27 Error Codes and Troubleshooting ..........28 Maintenance & Service Life ............29 Disposal ................... 30 Help ....................31 14. Warranty................... 32 © 2021 ZIBRIO...
  • Page 5 Congratulations on your ownership of a Stability Pro scale! We’re delighted to support you in helping others understand and manage their balance.
  • Page 6: Safety Information

    1.1 Limitations • The Stability Pro scale is not intended to diagnose or treat any illness or condition. While the Stability Pro scale measures balance, poor balance in itself is not a disease and can be caused by variety of conditions. If you suspect an underlying medical condition that is affecting someone’s balance, consult a doctor;...
  • Page 7: Care And Use

    • Maximum weight limit of 350 lbs. 1.2 Care and Use • Must be used on a hard, level floor. Balance scores and weights will likely be inaccurate if the scale is used on a carpeted floor or an uneven tile floor. •...
  • Page 8 while in use with a patient. • Avoid exposing the scale to magnetic fields, electromagnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, or thermal ignition sources, as these conditions may damage the product. • In the event that you observe unexpected behavior of the scale, follow the instructions listed in section 10, “Error Codes and...
  • Page 9: About The Stability Pro Scale And Zibrio Balance Test

    2.1 Intended Use The Stability Pro scale is intended to quantify balance and weight in adults. It is intended for professional use. It is not intended for self testing, and an operator should remain with the user to spot them as they mount and dismount the scale and to spot them for the duration of the test.
  • Page 10: Patient Contact

    2.2 Patient Contact The glass surface of the Stability Pro scale is the applied part, which will make contact with the patient. The patient should stand on the glass surface. The patient does not need to come in contact with any other parts of the device.
  • Page 11: What's In The Box

    3. WHAT’S IN THE BOX • Stability Pro scale (A) • Power Adapter (B) • User Manual • Quick Start Guide • Balance Test Instructions Poster unscrew to remove battery cover power adapter port...
  • Page 12: Scale Power Options

    4. SCALE POWER OPTIONS 4.1 Power Adapter To power the Stability Pro scale via a wall outlet, plug the included power adapter into the port on the left side of the front edge of the scale. Then plug into a wall outlet.
  • Page 13: Initial Setup

    Portable RF communication equipment that include antennas can affect medical electrical equipment, and should be placed no closer than 12 inches (30 cm) to any part of the Stability Pro, including cables specified by the manufacturer. •...
  • Page 14 this will lead to an inaccurate score. • Be sure to have a visual focal point on the wall for users to look at during the balance test. If testing in front of a blank wall, you can attach a printout of the Balance Test Instructions Poster onto the wall at eye level.
  • Page 15: Using The Stability Pro Scale

    2) Have the user step onto the scale and stand still. Once the weight has stabilized, the scale will display the user’s weight. 3) By default, the Stability Pro scale will display weight in pounds. If desired, the scale display can be changed to kilograms through the ZIBRIO Balance Coach mobile app, which connects to the scale via Bluetooth.
  • Page 16 c) Keep your eyes open during the test, and look forward. Do not look down or move your head during the test. d) Do not talk or chew gum during the test. 4) Assist the user in stepping onto the scale. Users’ feet should be a comfortable standing width apart.
  • Page 17 unsteady, spot them throughout the test. Remain out of eyesight of the user so that your movements do not distract them during the test. Stand directly behind them or behind them and to one side. 6) At the end of the test, the scale will beep and the balance score will be displayed on the scale (1-10).
  • Page 18: Understanding Balance Scores

    4-6 (yellow) means moderate risk of falling 7-10 (green) means low risk of falling Balance changes every day, and many systems affect it. The ZIBRIO Stability Score is a snapshot of a person’s balance right now. Do not be alarmed if a score varies by a few points from one test to another, this is normal.
  • Page 19: What If Someone's Balance Score Is Different Every Time They Take The Test

    It is not unusual for balance to change from day to day, or even throughout a single day. Remember that many factors influence balance, and those are always changing. Refer to the ZIBRIO clinical counseling materials to understand why a person may have scored the way they did today.
  • Page 20: Changing Scale Settings Through Mobile App

    If you still do not see the code, double-check to make sure you entered your email address correctly by filling out the “create account” page again. 5) Return to the ZIBRIO Balance Coach App to enter the 6-digit...
  • Page 21: Connecting To The Scale With A Smart Phone Or Tablet

    Note: If using an Apple device, the scale will not show up in the list of Bluetooth devices accessed from the “Settings” utility. The only way to connect to the Stability Pro scale with an Apple device is through the ZIBRIO Balance Coach app. You may connect to the Stability Pro scale through the Bluetooth utility with Android devices if desired.
  • Page 22: Modifying Scale Settings

    8.4 Modifying Scale Settings 1) Click the menu button in the upper left corner to access the menu. 2) Click “Scale Settings” to access the settings page. 3) Click “lb” or “kg” in the Weighing Mode box to select which unit you would like to scale to display weight in.
  • Page 23: Important Information

    The Stability Pro scale is Class A equipment. 9.1 Optimal Temperature and Environmental Conditions The Stability Pro scale is intended for operation in indoor settings such as clinics, group residence facilities, gyms, or individual homes. It shall operate, without degradation, in ambient temperatures between 5 °C (41 °F) and 40 °C (104 °F), a relative...
  • Page 24: Essential Performance

    at 1.4 dBm EIRP at 2480 MHz. This product has been certified for EMC compliance to IEC 60601-1-2; however strong electrical fields could interfere with the Bluetooth communication for this device. Nearby electrical equipment should be repositioned if malfunctions occur in usage. 9.3 Essential Performance Essential performance is defined as “performance of a clinical function, other than that related to basic safety, where loss or...
  • Page 25 Serial number - indicates the manufacturer’s serial number so that a specific medical device can be identified Date of manufacture - indicates the date when the medical device was manufactured Temperature limit - indicates the temperature limits to which the medical device can be safely exposed Humidity limitation - indicates the range of humidity to which the medical device can be...
  • Page 26: Declarations Of Conformity With The Us Federal Communications Commission (Fcc And Industry Canada (Ic) Regulations

    Atmospheric pressure limitation - indicates the acceptable upper and lower limits of atmospheric pressure for transport and storage 9.5 Declarations of Conformity with the US Federal Communications Commission (FCC) and Industry Canada (IC) Regulations USA - FCC This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules.
  • Page 27 Health Canada limits for the general population; consult Safety Code 6, obtainable from Health Canada’s website: http://www. hc-sc.gc.ca/ewh-semt/pubs/radiation/radio_guide-lignes_direct/ index-eng.php. MODIFICATION STATEMENT Any changes or modifications not expressly approved by ZIBRIO, Inc could void the user’s authority to operate the equipment.
  • Page 28: Emissions Limits/Group Immunity Test Levels

    9.6 Emissions Limits/Group, Immunity Test Levels Guidance and manufacturer’s declaration - electromagnetic emissions The Stability Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
  • Page 29 Guidance and manufacturer’s declaration - electromagnetic immunity The Stability Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test...
  • Page 30 Portable and mobile RF communications equipment should be used no closer to any part of Stability Pro, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 31: Resolution & Accuracy

    To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Stability Pro is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation.
  • Page 32: Error Codes And Troubleshooting

    If any of these components of the display does not light up, the display may be faulty, which could lead to inaccurate weight or balance score readings. In this case, contact ZIBRIO.
  • Page 33: Maintenance & Service Life

    • In the event that a replacement power adapter is needed, contact ZIBRIO for compatible replacement options. Do not use a power adapter other than one sold by ZIBRIO for use with the Stability Pro scale. • The Stability Pro scale and power adapter have an expected service life of 3 years (This statement does not imply warranty coverage.)
  • Page 34: Disposal

    12. DISPOSAL The Stability Pro scale is an electronic device. At the end of its life, it may be disposed of only in manners approved for disposal of electronic devices. Contact local authorities to determine proper methods of electronics disposal in your area. The Stability Pro scale...
  • Page 35: Help

    13. HELP Contact ZIBRIO to report unexpected operation or events, or if you need help. You can contact us by visiting www.zibrio.com/contact- or email us at support@zibrio.com. Headquarters: ZIBRIO, Inc. 2450 Holcombe Blvd Suite X Houston, TX 77021...
  • Page 36: Warranty

    This warranty may not be modified, amended or otherwise changed, except by a written document properly executed by a corporate officer of ZIBRIO. ZIBRIO, Inc. voids the warranty if the Stability Pro scale is opened or tampered with in any way without prior authorization from ZIBRIO, Inc.
  • Page 38 Supporting you to help others understand and manage their balance. www.zibrio.com/start ZIBRIO A-730-403-V8...

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