USER MANUAL
TABLE OF CONTENTS 1. Safety Information .......................................................................... 2 1.1. Limitations ............................................................................. 2 1.2. Care and Use ......................................................................... 3 2. About the ZIBRIO Pro Scale and ZIBRIO Balance Test ............. 5 2.1. Intended Use ......................................................................... 5 2.2. Resolution and Accuracy ...........
10. 11. 12. 13. 14. (IC) Regulations .......................................................................24 9.6. Emissions Limits/Group Immunity Test Levels ............. 26 Error Codes and Troubleshooting ................................................ 30 Maintenance & Service Life ........................................................31 Disposal ........................................................................................... 32 Help .......................................................
Congratulations on your ownership of a ZIBRIO Scale! We’re delighted to support you in helping others understand and manage their balance.
1. SAFETY INFORMATION At ZIBRIO we are very safety conscious, and we design and manufacture products with the safety of you, our valued customer, at the forefront. We ask that you adhere to the following precautions when using your ZIBRIO Pro scale. WARNING: No modification of this equipment is allowed. Do not use with accessories, detachable parts, or materials not described in this manual. 1.1 Limitations • • • • • • The ZIBRIO Pro Scale is not intended to diagnose or treat any illness or condition.
• 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. Should not get wet. Do not immerse in water. Be sure the surrounding floor and the surface of the scale are dry to avoid slipping when using the scale. If cleaning is needed, clean top glass surface with glass cleaner.
• • 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 Troubleshooting.
2. ABOUT THE ZIBRIO PRO SCALE AND ZIBRIO BALANCE TEST The ZIBRIO Pro Scale measures postural stability through the ZIBRIO Balance Test, which is a 60 second test with a two-legged, open-eyed stance. Balance is measured in Brios, on a scale from 1 to 10. 10 Brios represents the best possible balance across the human population. 1-3 Brios is associated with an increased risk of falling in adults ages 65 and up. The scale also measures weight.
optimized for children, and will not give an accurate measurement of a child’s balance ability. It is meant to assess balance in adults ages 18 and older and weighing at least 50 lbs. It may not assess balance accurately in the following populations: individuals with vestibular disorders, tremors, or attention and memory issues. Weights under 100 lbs are displayed with a resolution of 0.1 lbs and weights 100 pounds and above are displayed with a resolution of 1 pound.
uses by different patients. If the scale is being used barefoot, clean the glass surface of the scale between uses by different patients, following instructions in section 1.2. The scale does not need to be cleaned between uses with the same patient.
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4. SCALE POWER OPTIONS 4.1 Power Adapter To power the ZIBRIO 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. 4.2 Battery Power To operate the ZIBRIO Pro scale with batteries, open the battery compartment and add 6 new AA batteries (not included). Use a Phillips head screwdriver to remove the battery cover on the back of the scale.
5. INITIAL SETUP 5.1 Powering on the Scale • • Refer to section 4 for explanation of how to power the scale via power cord or batteries. To turn on the scale, place it on a flat surface and step or press on it. 5.2 Where to Put the Scale • • • • • • Place scale on a level, hard floor. Place the scale at least 1.5 feet from a wall, facing the wall, for a balance test. Some users who place the scale closer to wall report feeling visual discomfort during the balance test.
• • • 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 test instructions poster onto the wall at eye level. Some users have reported feeling dizzy if testing in front of a completely blank wall. Some users who use walkers feel more comfortable rolling their walker over the scale to assist their mount and dismount.
6. USING THE ZIBRIO PRO SCALE 6.1 Weight Measurement 1) If the scale was moved between uses, it is important to zero the scale to get an accurate weight reading. Zero the scale by pressing on it for 2 seconds and then releasing. The display should read “0.0”. If the scale was not moved since last use, skip this step. 2) Have the user step onto the scale and stand still. Once the weight has stabilized, the scale will display the user’s weight.
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. Their feet should not hang over any edges of the scale, and should be fairly centered. 5) Have the user stand still on the scale, complying with the test instructions.
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). After the user steps off the scale, the balance score will remain displayed for 10 seconds or until someone presses on the scale to zero it again.
7. UNDERSTANDING BALANCE SCORES 1-3 (red) means high risk of falling today 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 Balance 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. Many different factors affect a person’s balance score.
7.2 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. Some people’s balance scores will fluctuate by as many as 4 points from day to day.
8. CHANGING SCALE SETTINGS THROUGH MOBILE APP 8.1 Minimum Device Requirements The ZIBRIO Balance Coach App is compatible with… • Apple devices running iOS 12 and above, including: • iPhone 5S and later. • All iPad Air and iPad Pro models, iPad 5th generation, iPad 6th generation, iPad mini 2 and later. • iPod touch 6th generation models. • Android mobile phones running Android 4.0.0 and newer.
code and finish creating your account. 6) If you encounter any problems in the process of creating your account, visit our website at www.zibrio.com/support for FAQs and technical support. 8.3 Connecting to the Scale with a Smart Phone 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 ZIBRIO SmartScale with an Apple device is through the ZIBRIO Balance Coach app.
8.4 Modifying Scale Settings 1) Click the menu button in the upper left corner to access the menu. 2) Click “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. 4) Click “save” at the bottom of the settings page to save your changes. 5) Remember that settings will only be saved to the scale when the scale is connected. You cannot modify the scale settings when the scale isn’t connected.
9. IMPORTANT INFORMATION The ZIBRIO Pro Scale is Class A equipment. 9.1 Optimal Temperature and Environmental Conditions The ZIBRIO Pro Scale is intended for operation in indoor settings such as clinics, group residence facilities, gyms, or individual homes.
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 degradation beyond the limits specified by the manufacturer results in an unacceptable risk.” It is assumed there is no essential performance applicable to this scale. 9.
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 safely exposed Alternating current Direct current Class II equipment Medical device manufacturer - indicates the medical dev
Atmospheric pressure limitation - indicates the acceptable upper and lower limits of atmospheric pressure for transport and storage 23
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. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment.
CANADA - INDUSTRY CANADA (IC) This device complies with RSS 210 of Industry Canada. 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 this device. Caution: Exposure to Radio Frequency Radiation.
9.6 Emissions Limits/Group, Immunity Test Levels Guidance and manufacturer’s declaration - electromagnetic emissions The Zibrio 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. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The device must emit electromagnetic energy in order to perform its intended function.
Guidance and manufacturer’s declaration - electromagnetic immunity The Zibrio 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 IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic ±6 kV contact discharge (ESD) ±8 kV air IEC 61000-4-2 ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile.
Guidance and manufacturer’s declaration - electromagnetic immunity The Zibrio 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.
Guidance and manufacturer’s declaration - electromagnetic immunity The Zibrio 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. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
10. ERROR CODES & TROUBLESHOOTING “Err” is the scale’s error code, and might be displayed for the following reasons: • The user stepped off the scale before the balance test was complete, so a score cannot be calculated. If this occurs, repeat the balance test. • The user made erratic movements during the balance test that are not compatible with the test protocol, so a score cannot be calculated. If this occurs, repeat the balance test. • An unknown error occurred. Repeat the balance test.
11. MAINTENANCE & SERVICE LIFE • • • • • Inspect the scale and power adapter at least monthly for damage. Check for cracks in the glass or plastic surfaces. Check to ensure that the battery cover is firmly attached. Check to make sure all 4 foot pads are present and undamaged. Inspect power adapter for loose parts, fraying, or other damage. The ZIBRIO Pro Scale is factory calibrated and does not require user calibration.
12. DISPOSAL The ZIBRIO 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 ZIBRIO Pro Scale is not considered bio-hazardous material.
13. HELP Contact ZIBRIO to report unexpected operation or events, or if you need help. You can contact us by visiting www.zibrio.com/support or email us at support@zibrio.com. Headquarters: ZIBRIO, Inc.
14. WARRANTY Solely for the benefit of the original buyer, ZIBRIO INCORPORATED (“ZIBRIO”) warrants all new ZIBRIO Pro Scale products of its manufacture to be free from defects in material and workmanship, and will replace or repair, F.O.B., at its factory in Omaha, Nebraska, USA, or other location designated by ZIBRIO, any ZIBRIO Pro Scale products returned to it within twelve (12) months of original purchase by the buyer. Such repair or replacement shall be free of charge.
ZIBRIO, Inc. voids the warranty if the ZIBRIO Pro Scale is opened or tampered with in any way without prior authorization from ZIBRIO, Inc.
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