Related Manuals for Zimmer Biomet OrthoPak
Summary of Contents for Zimmer Biomet OrthoPak
- Page 1 Biomet OrthoPak ® ® Non-invasive Bone Growth Stimulator System Complete Manual and Package Insert...
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Page 2: Table Of Contents
Table of Contents SYSTEM CONTENTS ..........................1 IMPORTANT SAFEGUARDS ......................... 2 THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM ......3 ® ® • Description ........................... 3 • Electrical Requirements for Battery and Charger ................3 SYSTEM COMPONENTS ........................3,4 FULL PRESCRIBING INFORMATION .................... -
Page 3: System Contents
System Contents • Electrodes • Charger Cradle • Rechargeable Battery Packs (2) • Electrode Cover Patches • Stimulator • Device Holster • Lead Wires - 20” Lead Wire and 48” Lead Wire • Patient Manual • Complete Manual and Package Insert •... -
Page 4: Important Safeguards
If any of the replacement parts are damaged they must be replaced by Zimmer Biomet in order to avoid a hazard. 14. Do not short circuit, overcharge, crush, mutilate, nail penetrate, heat, reverse the + or - terminals or disassemble the battery pack. -
Page 5: The Biomet ® Orthopak ® Non-Invasive Bone Growth Stimulator System
Biomet OrthoPak Non-invasive Bone Growth Stimulator System ® ® Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Rx Only. Figure 1 This device is not intended for re-sale or re-distribution. Single patient use only. - Page 6 Battery temperature is too low or high 5°C to 38°C [41°F to 100°F] Battery voltage is too low Contact Zimmer Biomet for a new battery pack Electrodes A supply of electrodes is included with every assembly. The patient should replace electrodes every 1 to 7 days.
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Page 7: Full Prescribing Information
Full Prescribing Information INDICATIONS FOR USE The Biomet OrthoPak Non-invasive Bone Growth Stimulator System is indicated for the treatment of an ® ® established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visible progressive signs of healing. -
Page 8: Operating Instructions
Components in this system are to be used only with Zimmer Biomet approved parts. No attempt should be made to modify, repair or substitute parts or components for this device. - Page 9 4) If a battery pack is in the charger cradle 3) Following arrows, install the battery and no light is illuminated, an error is pack into the battery charger cradle as indicated. See page 14 for possible error illustrated (1) Lightly press down on reasons and possible solutions.
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Page 10: Step 2: Preparing The System To Begin Treatment
3) Insert the uncharged battery pack into the 2) Following arrows, insert the charged battery charger cradle by pushing it onto the battery pack into the Biomet OrthoPak ® ® charger cradle (1). Lightly press down on Non-invasive Bone Growth Stimulator the battery pack to ensure contact (2). -
Page 11: Step 3: Recharging The Battery Pack
Do not be concerned if the battery pack is inadvertently charged more than once or kept on the charger cradle for a long period of time. When the Biomet OrthoPak Non-invasive Bone Growth Stimulator System needs a fully charged ® ®... - Page 12 With use, the electrode gel area may dry out and the electrode may lose its contact with the skin. (This may cause the LED on the stimulator blink intermittently, and cause an audible intermittent alarm sound). If this occurs, the electrode may be reapplied. If dry, moisten the entire gel area of the electrode with tap water.
- Page 13 OrthoPak Non-invasive Bone Growth Stimulator System. Lead ® wires are provided in two lengths: 20, and 48 inches. Additional lengths are available from Zimmer Biomet. Figure 7 Electrode Cover Patches Electrode Cover Patch Electrode cover patches are available to be used for non-casted applications by patients who are experiencing difficulty keeping the electrode pads in good contact with the skin.
- Page 14 Immobilization Techniques may vary with each patient, requiring the use of a cast, brace, or splint. The patient is given a number of options for wearing/carrying the Biomet OrthoPak Non-invasive Bone Growth Stimulator ® ® System, depending on the type of immobilizer used. In the event of a casted application, it will be necessary to access electrode skin sites through prepared windows.
- Page 15 Remote Mount Use the enclosed holster and/or extremity band to directly attach the stimulator to a brace, splint or cast. (Figure 15) Connection of Electrodes If the stimulator is worn at the waist (Figure 16) select the 48-inch electrode lead wire. Figure 15 If the stimulator is to be placed on the extremity band, select the 20-inch lead wire.
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Page 16: Lcd Symbols Description And Instructions
This data may be downloaded to a personal computer for viewing, storage and/or print out via the use of Biomet Compliance Data Download Software. Please call your local Zimmer Biomet representative to obtain more information. -
Page 17: Ordering Information
Ordering Information To order supplies, contact Zimmer Biomet. See page 2, “Important Safeguards”, for contact information. The following information is necessary to expedite any inquiry: • Patient name • Physician name • Address to send replacement items (patient home, MD office, etc.) Equipment Classification •... -
Page 18: Cleaning Instructions
Cleaning Instructions Use a damp cloth for cleaning any part of the Biomet OrthoPak Non-invasive Bone Growth ® ® Stimulator System. Do not use cleaning products or detergents. Electromagnetic Compatibility A. The use of accessories, lead wires or replacement parts other than those supplied by Zimmer Biomet may result in increased emissions or decreased immunity of the equipment or system. - Page 19 Table 2 Guidance and manufacturers declaration - electromagnetic immunity The Biomet OrthoPak Non-invasive Bone Growth Stimulator System is intended for use in the ® ® electromagnetic environment specified below. The customer or the user of the Biomet OrthoPak ® ®...
- Page 20 Table 3 Guidance and manufacturers declaration - electromagnetic immunity The Biomet OrthoPak Non-invasive Bone Growth Stimulator System is intended for use in the ® ® electromagnetic environment specified below. The customer or the user of the Biomet OrthoPak ® ®...
- Page 21 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the Biomet OrthoPak Non-invasive ® ® Bone Growth Stimulator System The Biomet OrthoPak Non-invasive Bone Growth Stimulator System is intended for use in an ® ® electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user...
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Page 22: Patient Counseling Information
The device components should be handled with care. Damage may occur if the device is inappropriately handled or abused. Disposal Instructions When treatment has concluded as determined by the prescribing physician, Zimmer Biomet requests that the patient dispose of the Biomet OrthoPak Non-invasive Bone Growth Stimulator System ®... -
Page 23: Electrode Instructions For Use
Electrode Instructions for Use Do not open outer packet until ready to use. 1) Tear open packet. 2) Remove electrode from clear plastic backing liner. 3) Wet finger with tap water and moisten entire gel area. 4) Place electrode on skin. 5) Connect electrode to electrode lead. - Page 24 PN # 1067799-00 Rev. F 399 Jefferson Road • Parsippany, NJ 07054 800.526.2579 • zimmerbiomet.com/bonehealing • BNS231000L 11/19 ©2019 Zimmer Biomet. All rights reserved. All trademarks are the property of Zimmer Biomet or its affiliates, unless otherwise indicated. Rx Only.