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 ® Physician Manual and Package Insert English Language...
-
Page 2: Table Of Contents
Contents Important Safeguards and Contents ......... Page 1 Biomet EBI Bone Healing System ........Page 2 ® Description ..............Page 2 Electrical Requirements ..........Page 2 System Components ............Page 3 Full Prescribing Information ..........Page 4 Indications for Use ............Page 4 Contraindications ............Page 4 Warnings, Precautions, Adverse Effects ....... Page 5 General Treatment Instructions ......... Page 6 Operating Instructions ............Page 8 Step 1: Battery Charging ..........Page 8 Step 2: Preparing the System to Begin Treatment .. -
Page 3: Important Safeguards And Contents
16. Use of your bone healing system for the Wall Adapter, in any liquid. spine and skull has not been evaluated or 4. Do not reach for your bone healing system approved. that has fallen into a liquid. Unplug from *NOTE: Please contact the Biomet Patient the wall outlet immediately. Support Department in Parsippany, New Jersey 5. Do not permit the AC Wall Adapter to be between the hours of 8:30 a.m. and 5:30 p.m. connected when wet. Eastern Time at 1.973.299.9300 with any 6. Never touch the AC Wall Adapter contacts questions or problems. -
Page 4: Biomet ® Ebi Bone Healing System
Biomet EBI Bone Healing System ® SFLX Treatment Coil Description The Biomet EBI Bone Healing System ® promotes healing by inducing weak pulsing electrical currents at the fracture nonunion site. These signals are generated by a low energy electromagnetic field created by passing specific current pulses through an anatomically configured treatment coil. Electrical Requirements of AC Wall Adapter Unit –... -
Page 5: System Components
Biomet sales representative. treatment coil to each follow-up visit to provide the opportunity to review their overall treatment *NOTE: The Control Unit must not be worn complinace in how they are using their Biomet ® on the coil. EBI Bone Healing System. *NOTE: While walking, the patient may wear the control unit comfortably on a belt or the waist using the Clip Holder. -
Page 6: Full Prescribing Information
Intended User Profile 1. B assett CAL, N Caulo and J Kort, “Congenital The EBI Bone Healing System is intended to ® pseudarthrosis of the tibia: Treatment with treat adults who have been medically diagnosed pulsing electromagnetic fields”. with a fracture nonunion or failed fusion in the Clinical Orthop, 154: 136-149,1981. appendicular system. It is also intended to treat... -
Page 7: Warnings, Precautions, Adverse Effects
C. U se of the Biomet EBI Bone Healing ® and distributors provide to the FDA based upon System for the spine and skull have not relevant product codes for similar devices. been evaluated. The original EBI Bone Healing System was approved D. To reduce the risk of potential injury: and introduced in 1979. Since then, over 600, 000 1. A VOID touching the AC Wall Adapter systems have been marketed. The safe and effec- contacts when the AC Wall Adapter is tive use of non-invasive bone growth stimulation plugged into an AC outlet. devices over this time has clearly established their 2. D O NOT charge the battery in bed if... -
Page 8: General Treatment Instructions
EBI Bone Healing System is The Biomet clock will automatically reset and be ready to ® programmed to deliver a maximum of 270 deliver the next 10 hour therapeutic treatment therapeutic treatment periods. Biomet period when next turned on. - Page 9 • Scaphoid/Wrist: stable internal fixation or ATTENTION: This is a single patient use device, long arm cast with thumb spira (short arm do not reuse. For Prescription Use Only. The cast with rigid fixation) Biomet EBI Bone Healing System is a durable ® therapeutic electrical device intended for single • Carpals/Metacarpals/Phalanges: cast, patient use only under a prescription. Treatment internal, or external fixation at home or in another appropriate or similar setting is acceptable.
-
Page 10: Operating Instructions
Lithium Ion battery and cannot be replaced by a service technician. You must Step 1: Battery Charging read and follow these safety instructions and The Biomet EBI Bone Healing System ® warnings in conjunction with the Important operates on a lithium ion battery. Before safeguards provided within this manual before treating with the system, the patient must fully using or charging the battery within your charge the battery. At room temperatures,... -
Page 11: Step 2: Preparing The System To Begin Treatment
Normal charging temperature range is 50°F within the coil treatment window. During (10°C) to +95°F (35°C). treatment, the position of the treatment coil may shift due to patient activity. The treatment Step 2: Preparing the System to Begin Treatment coil must be adjusted and centered as required The Biomet EBI Bone Healing System includes ® to cover the fracture nonunion site. two link cables: “zero” length and 28". The cable exiting the controller is 4 1/2" long. All Step 3: Treating and Charging SFLX Treatment Coils have an 8" cable. Hence, Patients may treat with the system while use of the “zero” length link cable would recharging the battery. When the patient treats... -
Page 12: Step 4: Recharging The Batteries
RECHARGE BATTERY After completing a daily treatment session, patients should do the following: TREATMENT HALTED A. Turn the controller off. After daily treatment, turn the controller OFF and recharge as described in step 1: Battery B. Follow instructions A-C from Charging. (See page 8). Step 1. Controller (Page 8) *NOTE: An excessively low battery will result in C. I t is not necessary to disconnect the no LCD display. controller from the AC Adapter charger once If you are experiencing charging difficulties, fully charged. The controller can remain please verify that all electrical connections are plugged into the AC Wall Adapter until the established. Then try charging the controller patient’s next treatment session. again. If you are still experiencing difficulties, contact Biomet. For a complete listing of contact information, refer to page 29. -
Page 13: Controller Holder
Battery Indicator Display An audible click should be heard, thus The capacity of the battery is displayed during securing the controller to the holder. the course of treatment. Four bars indicates a full charge with three bars indicating • Adjust clip holder placement to maximize approximately 75% charge. patient comfort and avoid possible impacts with furniture, etc. California Perchlorate Label The controller contains a permanently installed Keep the Bone Healing System and its back up battery mounted on the printed circuit accessories away from small children board that contains very small amounts of perchlorate. California law requires the following... -
Page 14: Keypad Functions
AVG HR/DAY 00:00 controller on, press the on/off button one time. Pressing this button a second time for at least one second will turn the controller off. Every time the controller is turned on, the display will PATIENT USAGE indicate the following sequence: DAYS USED 000 1. “ RECOMMENDED USE 10 HOURS PER DAY” for the Biomet EBI Bone ® PATIENT USAGE Healing System. DAYS UNUSED 000 2. “ PATIENT USAGE”; “AVG HR/DAY 00:00” - This is the daily treatment average since the TREATING 0:00 patient’s treatment started. -
Page 15: Troubleshooting System Messages
SEE MANUAL 2. I nsert the AC Adapter charger into the controller to recharge the battery for your next treatment (see Step 1: BATTERY ”Check Coil See Manual” CHARGING page 8). This message, accompanied by three to The Biomet EBI Bone Healing System may ® four audible beeps, appears when the SFLX be used at home or at work. Your patient’s Treatment Coil is disconnected, damaged, schedule and lifestyle will determine the best or inappropriately flexed. The message will time for using the system. Many people find it stay on the display until the controller turns convenient to treat while they are sleeping. -
Page 16: Compliance Data Software
Operating Instructions (Continued) Compliance Data Software Introduction “Cannot Treat Call Biomet 1.973.299.9300” (Physician Use Only) This message, accompanied by three audible This bone healing system contains embedded beeps, appears when there is a hardware software and firmware which allows the display problem within the controller. The message of patient-specific history data including usage “CANNOT TREAT” will appear and alternate... - Page 17 Troubleshooting days un-used and days lapsed. Total treatment If connection or printing problems occur, time is displayed along with a graph of the please check all connection cables or your number of treatment sessions recorded at network administrator. Please call Biomet (page specific treatment duration hour intervals. 29) should any additional problems arise. Care should be taken not to manipulate data in Warnings any way. The Compliance Data Download Software must only be run on a personal computer operated Biomet recommends patients bring their by or under the guidance and supervision of a controller to each follow-up visit so that Biomet sales representative. This software...
- Page 18 Operating Instructions (Continued) Sample Patient Usage Report Device: Biomet EBI Bone Healing System ® Serial Number: 0002 Days Lapsed: Days Used: Days Unused: Avg Hours / Day: 4:13 Avg Hours / Session: 6:22 Total Treatment Time: 417 Hours Treatment Period:...
-
Page 19: Sflx Flexible Treatment Coils
SFLX Treatment Coils Depth of Penetration Specifications for SFLX Treatment Coils SFLX 1, 2, 3, 4, 5, and Coilette Treatment Coils Tolerances SFLX Coil M/L Flexion Depth of Vertical Anatomical Penetration Fracture Length Location(s) SFLX Mini Coilette Minimum 2.5 cm 2.5 cm 1.5 cm phalanges Maximum 3.5 cm... -
Page 20: Sflx-1, Sflx-2, Sflx-3, Sflx-4 And Sflx-5 Coil Application
(Continued) *NOTE: The Biomet EBI Bone Healing All SFLX Coil – Anatomical placement ® System does not include a treatment coil. The instructions and Flexion Gauges are included prescribing physician and Biomet representative with the coil. will select the treatment coil suitable for the particular part of the patient’s anatomy to be Specialty treatment coils are for applications treated. If initially treating with a cast treatment where the standard straps may not be adequate coil can be interchanged in the event a cast is to secure the treatment coil. -
Page 21: Conforming The Sflx Treatment Coil
The opposite treatment coil edge should fall within the green zone in the area marked “FLEXION RANGE”. Each Flexion Gauge has a chart of treatment coil tolerances with depth of penetration data. *NOTE: During treatment, the position of the treatment coil may shift due to patient activity. 3) I f the treatment coil edge does not fall The treatment coil strap(s) may be loosened within the green zone contact your Biomet and the coil adjusted and centered as required representative for a suitable replacement to cover the fracture nonunion site. Tighten the and assistance. straps again to finish the correction. -
Page 22: Casted And Noncasted Applications
Casted and Noncasted Applications Casted Applications: Noncasted Applications: 1. A pply one to two rolls of casting material 1. P osition the SFLX Treatment Coil over the (synthetic or plaster) in the usual manner, fracture nonunion site. The entire fracture and allow it to set. Center the SFLX nonunion site should be centered within the Treatment Coil over the fracture nonunion treatment coil window/field of influence. site, confirming correct placement with an X-ray if necessary. 2. A ttach and secure the SFLX Treatment Coil around the extremity with the Velcro strap †... -
Page 23: Cleaning Instructions
Cleaning Instructions Treatment Completion Biomet EBI Bone Healing System Biomet EBI Bone Healing System ® ® The controller and AC Wall Adapter can be The maximum recommended therapeutic cleaned by wiping with a damp cloth and mild treatment period is nine months (approximately soap. Do not immerse in water or use solvents 270 days). or other cleaning agents. DO NOT MACHINE WASH OR DRY When the Control Unit reaches system endpoint, the signal is locked. “SYSTEM ENDPOINT CALL... -
Page 24: Returning Defective Product
Equipment Classification Symbol Description Warning • Biomet EBI Bone Healing System ® Class II Note Type BF Type BF Equipment • Ordinary equipment without protection Direct Current against ingress of water Alternating Current • Equipment not suitable for use in presence of flammable anaesthetic Attention – See Instructions mixture with air or with oxygen or with nitrous oxide Non-ionizing Radiation Class II • Mode of operation – continuous Single Patient Use / Single Prescription Disposal/Recycling The control unit, AC Wall adapter, link cables, WEEE – Do not dispose of this SFLX Treatment Coil are regulated and should device with household waste... -
Page 25: Ordering Information
Ordering Information References To order replacement treatment coils or related C.A.L. Bassett, Robert J. Pawluk, and A.A. Pilla. components contact your Biomet representative “Augmentation and Bone Repair by Inductively or call the Biomet Patient Support Department Coupled Electromagnetic Fields”. Science . to 5:30 directly at 1.973.299.9300, 8:30 184:575-577, 1974. . Eastern Time Monday through Friday. Outside the United States contact your local C.A.L. Bassett, S.N. Mitchell, L. Norton, N. EBI/Biomet Distributor. Caulo and S.R. Gaston. “Electromagnetic Repairs of Non-Unions. Electrical and Magnetic The Following Information is Necessary to Control of Musculoskeletal Growth and Repair”. Expedite Any Requests: C.T. Brighton, ed., Grune and Stratton, New York, 1979. -
Page 26: Biomet ® Ebi Bone Healing System Components
Biomet EBI Bone Healing System Components ® Accessories Replacements and Components Catalog # Description Catalog # Description 1067725-00 USB Cable For Compliance 1068234 Controller Assembly – USA Download 1068233 Controller Only RP 1068208 Clip Holder RP 1068209 Extremity Band 1068222 Belt Strap RP 1068315 AC Wall Adapter RP – USA 1068225 SFLX 1 Coil 1068226 SFLX 2 Coil 1068227 SFLX 2-1 Coil 1068228 SFLX 2-4 Coil... -
Page 27: Electromagnetic Compatibility
Table 1 Guidance and Manufactures Declaration – Electromagnetic Emissions The Biomet EBI Bone Healing System is intended for use in the electromagnetic environment ® specified below. The customer or the user of the Biomet EBI Bone Healing System should assure ® that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions Group 1... - Page 28 Electromagnetic Compatibility (Continued) Table 2 Guidance and Manufactures Declaration – Electromagnetic Immunity The Biomet EBI Bone Healing System is intended for use in the electromagnetic environment ® specified below. The customer or the user of the Biomet EBI Bone Healing System should assure ® that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Electromagnetic Level...
- Page 29 Table 3 Guidance and Manufactures Declaration – Electromagnetic Immunity The Biomet EBI Bone Healing System is intended for use in the electromagnetic environment ® specified below. The customer or the user of the Biomet EBI Bone Healing System should assure ® that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Electromagnetic Level Environment - Guidance...
- Page 30 The Biomet EBI Bone Healing System is intended for use in an electromagnetic environment in ® which radiated RF disturbances are controlled. The customer or the user of the Biomet EBI Bone ® Healing System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile communications equipment (transmitters) and the Biomet ® EBI Bone Healing System as recommended below, according to the maximum power output of the communications equipment. Separation Distance (Meters) According to Frequency of Transmitter Rated Maximum Output 150 kHz to 80 MHz 80 MHz to 800 MHz 150 MHz to 2.5 GHz...
-
Page 31: Further Information
Further Information Biomet 399 Jefferson Road Parsippany, New Jersey 07054 1.973.299.9300 If you are a patient and need to contact Biomet, please use the following numbers: Ordering Replacements • Patient Services Department • 1.973.299.9300 Returns/Defective Products/ Troubleshooting • Quality Assurance Department • 1.973.299.9300 Questions About Your Bill • Patient Advocacy Department • Phone: 1.888.236.3652 (USA only) • e-mail: patientadvocate@biomet.com... -
Page 32: Reimbursement Form
• b eyond the usual postoperative care Physician______________________________ associated with the procedure(s) performed; and, Date__________________________________ • t he physician is providing and meeting Physician Management of Biomet Stimulators the three, key components (e.g., history, are generally recognized under CPT code 20974. examination and medical decision This code encompasses services associated making). - Page 33 Notes:...
- Page 34 Notes:...
- Page 36 Biomet EBI Bone Healing System ® Physician Manual and Package Insert English Language 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 • 1068220-00 Rev. A • BNS231188L ©2013 EBI, LLC. All rights reserved. All trademarks are the property of Biomet, Inc. or one of its subsidiaries unless otherwise indicated. denotes a third party trademark. Velcro is a registered †...