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Related Manuals for BIOMET EBI Bone Healing System
Summary of Contents for BIOMET EBI Bone Healing System
- Page 1 The Biomet EBI Bone Healing System ® Patient Manual...
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Page 2: Table Of Contents
Contents Introduction................. Page 1 Symbol Description ..............Page 2 Warnings ..................Page 3 Battery Warning ............... Page 5 Indications, Contraindications, Usage and Adverse Effects ..Page 7 Indications: ................Page 7 Contraindications: ..............Page 7 Usage: ..................Page 8 Adverse Effects: ............... Page 8 What does a Bone Healing System do?........ -
Page 3: Introduction
Please read through the entire manual before operating. Biomet is committed in providing every opportunity to you to achieve a successful outcome. If you have any questions or concerns regarding your Bone Healing System or one-on-one personal training please feel free to contact Biomet directly or your local sales representative at any time. -
Page 4: Symbol Description
Lithium Ion Battery – Single Patient Use / Recycle in compliance Single Prescription with local laws WEEE – Do not dispose The Biomet EBI Bone ® of this device with Healing System has not household waste been tested for safety or... -
Page 5: Warnings
Never operate your bone healing system if it has a damaged link cable, cord or plug, if it is not working properly, if it has been dropped and damaged, or immersed into any liquid. Contact Biomet immediately for a replacement part(s). Keep all electrical cords and cables away from heated surfaces. - Page 6 Warnings (Continued) 10. Keep the Bone Healing System and its accessories away from small children. This device is not a toy and may be hazardous to children. For example: • A choking hazard may exist for detachable parts • I mproper use could result in exposure to a treatment signal for which the risks of exposure to children have not been established 11.
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Page 7: Battery Warning
Battery Warning CAUTION: The Biomet EBI Bone Healing System control unit contains ® a permanently installed Lithium Ion battery. You must read and follow these safety instructions and warnings provided within this manual before using or charging the battery within your control unit. - Page 8 Any abuse or misuse to the control unit or its permanently installed battery may result in serious personal injury and/or property damage. Biomet is not liable for any such abuse, misuse or resulting damage. To ensure proper charging, ONLY USE the AC Wall Adapter supplied with your device system and follow the specific operating instructions provided within this manual.
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Page 9: Indications, Contraindications, Usage And Adverse Effects
4. The Biomet EBI Bone Healing System has not been tested for ® safety or been evaluated for heating in the MR environment. The effects of MRI procedures and scans using MR systems has not been determined or established”... -
Page 10: Usage
Rx Only - Prescription Only - Single Use Only - Not for Re-Sale or Re-Distribution - Do Not Reuse. Adverse Effects: The original EBI Bone Healing System was approved and introduced ® in 1979. Since then, over 600,000 systems have been marketed. The safe and effective use of non-invasive bone growth stimulation devices over this time has clearly established their therapeutic benefit of use. -
Page 11: What Does A Bone Healing System Do
Your doctor has prescribed the Biomet EBI Bone Healing System to ® help heal your fracture nonunion or failed fusion. The Biomet ® Bone Healing System is a proven, safe and effective medical device. The system consists of an anatomically configured flexible treatment coil that can be worn directly over a cast or worn over clothing or directly on the skin during treatment. -
Page 12: What Comes In The System Kit
What does a Bone Healing System do? (Continued) What comes in the System Kit? • Electronic control unit/controller - #1068233 • Controller to Coil Connector link cables: - “Zero” inch link cable - #1068210 - 28 inch link cable - #1068215 • Belt - #1068222 • Clip Holder - #1068208 • AC Wall Adapter - #1068315 • Physician’s Manual • Patient Manual Biomet EBI Bone Healing System Kit Contents ®... - Page 13 Physicians Manual Patient Manual If at any point you need a replacement part for your Bone Healing System please contact Biomet directly at 1.800.526.2579 and reference the part number next to the description of the item you need to order.
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Page 14: Additional Components
Additional Components SFLX Flexible Therapeutic Treatment Coils In addition to your Biomet EBI Bone Healing System you have also ® received an SFLX flexible therapeutic treatment coil. The coil you have depends on the type and location of your fracture nonunion or failed fusion your doctor diagnosed. -
Page 15: Extremity Band
Extremity Band An optional extremity band is also available if you would like to wear your Bone Healing System’s electronic control unit closer to your treatment site, for example on your arm. When ordering the extremity band, reference part number #1068209 and it will be shipped to you with important user and safety instructions. -
Page 16: How Do I Connect My Control Unit To My Treatment Coil
How do I connect my control unit to my treatment coil? First, connect the controller (A) to either the “Zero” inch or 28 inch Link Cable (B). Then connect Link Cable (B) to the Treatment Coil (C). The Link Cable selection depends on which cable length best fits your specific treatment needs. -
Page 17: How Do I Start My Treatment
Press once and release for the Button on the left beneath display’s backlight to come on the display and Biomet logo Backlight/Reset * NOTE: If you hold down the backlight button for two beeps, the control unit will reset its internal clock to 00:00 treatment time for... - Page 18 How do I start my treatment? (Continued) 3) The display on your control unit will scroll through the following five messages. FIRST MESSAGE: Your compliance with the EBI RECOMMENDS recommended 10 hours per 10 HOURS PER DAY day treatment is very important. A review of the clinical data demonstrated that less than the recommended use may possibly...
- Page 19 You can also request an optional extremity band from Biomet if you would like to wear the controller closer to your treatment site, for example on your arm.
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Page 20: How Do I Charge My Battery
How do I charge my battery? 1) In order to charge your Bone Healing System’s battery, connect the AC Wall Adapter (A) to the control unit (B) as shown: 2) Then, plug the AC Wall Adapter into an appropriate AC Wall outlet. * NOTE: You are able to treat and charge at the same time. -
Page 21: Cleaning Instructions
Your Bone Healing System’s control unit is programmed to deliver a maximum of 400 consecutive days of treatment. When 400 days of treatment are reached, treatment automatically stops and the following message will be displayed: “SYSTEM ENDPOINT CALL BIOMET”. -
Page 22: Disposal
(Continued) Disposal When your treatment has concluded as determined by your doctor, Biomet requests that you properly dispose your Bone Healing System according to local statutes and regulations. What if I have questions? If you have questions about your Biomet EBI Bone Healing System, ®... - Page 24 Patient Manual To learn more about this product, contact your local Biomet Sales Representative today. 399 Jefferson Road • Parsippany, NJ 07054 800.526.2579 • www.biomet.com • BNS231187L 12/12 ©2012 EBI, LLC. All rights reserved. All trademarks are the property of Biomet, Inc. or one of its subsidiaries unless otherwise indicated. Rx Only.
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