BIOMET EBI Bone Healing System Physician Manual And Package Insert Download Page 2 | Manualshive

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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 9
  Step 3: Treating and Charging ...................................... Page 9
  Step 4: Recharging the Batteries .................................. Page 10
  Controller Holder ........................................................... Page 11
  Keypad Functions .......................................................... Page 12
  Troubleshooting System Messages .............................. Page 13
  Compliance Data Software ............................................ Page 14
SFLX Flexible Treatment Coils ........................................... Page 17
SFLX-1, SFLX-2, SFLX-3, SFLX-4
and SFLX-5 Coil Application ............................................. Page 18
  Conforming the SFLX Treatment Coil ........................... Page 19
  Casted and Noncasted Applications ............................. Page 20
  Cleaning Instructions .................................................... Page 21
Treatment Completion ....................................................... Page 21
Returning Defective Product ............................................. Page 22
  Equipment Classification ............................................... Page 22
  Disposal/Recycling ....................................................  Page 22
  Symbol Description....................................................... Page 22
Ordering Information ......................................................... Page 23
References ......................................................................... Page 23
Biomet

®

EBI Bone Healing System Components .............. Page 24

Electromagnetic Compatibility ........................................... Page 25
Further Information ........................................................... Page 29
Reimbursement Form ....................................................... Page 30

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Summary of Contents for EBI Bone Healing System

Page 1: ...The Biomet EBI Bone Healing System Physician Manual and Package Insert English Language ...

Page 2: ...he Batteries Page 10 Controller Holder Page 11 Keypad Functions Page 12 Troubleshooting System Messages Page 13 Compliance Data Software Page 14 SFLX Flexible Treatment Coils Page 17 SFLX 1 SFLX 2 SFLX 3 SFLX 4 and SFLX 5 Coil Application Page 18 Conforming the SFLX Treatment Coil Page 19 Casted and Noncasted Applications Page 20 Cleaning Instructions Page 21 Treatment Completion Page 21 Returning...

Page 3: ...g system 12 Do not place your bone healing system s control unit in prolonged heat or direct sunlight Normal operating temperature range is 5 C to 38 C 41 F to 100 F 20 80 RH non condensing normal storage transport temperature is 15 C to 60 C 5 F to 140 F 13 Use your bone healing system only for its intended use as prescribed by your physician and described in this manual 14 No modification to thi...

Page 4: ... coil Electrical Requirements of AC Wall Adapter Unit USA Americas Input 100 240V 50 60Hz 0 3 0 8 A Output 12V 2 0A MAX Do not use any other AC wall adapter with the Biomet EBI Bone Healing System Electrical Requirements The Biomet EBI Bone Healing System Control unit is available in the following configuration Americas Includes an AC Adapter charger with a standard two prong plug NOTE An Internat...

Page 5: ...dapter 1 The AC Wall Adapter is designed to recharge the permanently installed battery inside the control unit See step 3 Treating and Charging page 9 2 The control unit allows for treating while charging Do not use any other AC Wall Adapter with the Biomet EBI Bone Healing System Link Cable The link cable connects the control unit to its SFLX Flexible Treatment Coil The link cables supplied are z...

Page 6: ...ere not included in the original study designs a follow up rate of 82 was achieved Forty three 43 of the original 48 patients in the congenital pseudarthrosis study were classified by Bassett1 who defined the tibial lesions as Type I n 6 Type II n 19 and Type III n 18 with Type III being the most severe and recalcitrant to treatment The success rate for Bassett Type I lesions was 66 7 Bassett Type...

Page 7: ... NOT immerse the control unit treatment coil or the AC Wall Adapter in any liquid Precautions The following conditions may compromise a successful treatment outcome A Nonunion fractures with gaps in excess of 1 0 cm B Presence of fixation devices or instrumentation made from magnetic materials Please note Most presently used internal or external fixation devices are constructed of 316L S S titaniu...

Page 8: ... place for four hours turns the device off and does not push the RESET button Patient then turns the device on within the next 12 hours and only completes the remaining six hours of treatment for that therapeutic treatment period Shortened Segmented A treatment period of less than 10 hours may be achieved by pushing the reset button prior to the completion of the 10 hour period Once the device has...

Page 9: ...d etc with the intent to be used by another patient or for treatment other than initially prescribed This device has been designed to reduce the risk of potential reuse by automatically ceasing to function in accordance with the General Treatment Instructions specified and defined within Recommended Concurrent Fracture Treatment The Biomet EBI Bone Healing System works best when motion of the frac...

Page 10: ...m Ion battery and cannot be replaced by a service technician You must read and follow these safety instructions and warnings in conjunction with the Important safeguards provided within this manual before using or charging the battery within your control unit Do not attempt to open the control unit to access the battery or its internal electronic components for any reason No unauthorized modificat...

Page 11: ...ls used with the EBI Bone Healing System Model 2001 After confirming that the link cable is properly connected to the controller connect the other end of the link cable to the SFLX Flexible Treatment Coil This connection allows for simple quick disconnect and reconnect by the patient Next position the SFLX Flexible Treatment Coil over the fracture nonunion site The entire fracture nonunion site sh...

Page 12: ... Wall Adapter until the patient s next treatment session NOTE The controller s permanently installed battery cannot be overcharged If the controller is plugged into the AC Adapter and the battery is fully charged the charger will terminate the recharging process early During the charging process the LED adjacent to the plug will remain orange and once the charging is complete the LED will turn gre...

Page 13: ... Controller Clip Holder The controller may be worn on a belt in a clip holder that is included in the system or in the optional extremity band The holder will securely hold the controller during normal treatment To insert the controller into the clip holder align the front of the controller that features the reset backlight button facing away from the clip holder Align the slots on the controller ...

Page 14: ...et button has not been pressed see RESET BUTTON 6 Pressing the RESET button will result in the display reading RESETTING for ap proximately three seconds The display will then return to display as indicated in number five above 1 2 3 4 5 6 RECOMMENDED USE 10 HOURS PER DAY PATIENT USAGE AVG HR DAY 00 00 PATIENT USAGE DAYS USED 000 PATIENT USAGE DAYS UNUSED 000 TREATING 0 00 BATTERY RESETTING RESET ...

Page 15: ...rs the battery needs to be recharged This message will only appear during a treatment session In order to recharge the battery and continue treatment connect the AC Wall Adapter and turn the controller on Refer to Step 4 Page 10 RECHARGING THE BATTERY Check Connectors See Manual This message accompanied by audible beeps appears when the controller is not properly connected to the SFLX Treatment Co...

Page 16: ...ains embedded software and firmware which allows the display of patient specific history data including usage and therapeutic treatment time via use of Biomet Compliance Data Download Software The Compliance Data Download Software is classified as a medical device data system MDDS Its primary function is the electronic retrieval transfer display and storage of device generated specific patient his...

Page 17: ...fer your Biomet representative has this 2 Call Contact your local Biomet representative to arrange download of the Compliance Data Download Software Connect the USB Accessory cable for compliance download PN 1067725 00 to the device s USB port located on the side of the controller to the left of the power button Connect the USB cable to an open USB port on a PC Turn on the device Open the Complian...

Page 18: ...d 1 Days Used 78 Days Unused 21 Avg Hours Day 4 13 Avg Hours Session 6 22 Total Treatment Time 417 Hours Treatment Period 123 Days Demonstration mode Invalid Data Frequency of Treatment Dose 20 18 16 14 12 10 8 6 4 2 0 0 1 1 2 2 3 3 4 4 5 5 6 6 7 7 7 7 7 14 14 12 11 10 9 7 8 8 9 9 10 Treatment Hours Number Of Sessions Sample ...

Page 19: ...addle Maximum 11 cm 7 cm 10 cm SFLX 2 4 Minimum 8 cm 8 cm 10 cm Maximum 11 cm 7 cm 10 cm SFLX 3 Minimum 5 cm 7 cm 7 cm Maximum 9 cm 5 5 cm 6 cm SFLX 4 Minimum 9 25 cm 10 cm 12 cm Maximum 14 5 cm 8 cm 8 cm SFLX 4 1 Minimum 9 25 cm 10 cm 12 cm Saddle Maximum 14 5 cm 8 cm 8 cm SFLX 4 1 Minimum 12 cm 6 cm 22 cm Elliptical Maximum 14 cm 6 cm 18 cm SFLX 4 4 Minimum 9 25 cm 10 cm 12 cm Maximum 14 5 cm 8 ...

Page 20: ... for the SFLX 1 SFLX 2 SFLX 3 SFLX 4 and SFLX 5 Treatment Coils Applies to Description Treatment Coil Suggested Placement SFLX 1 1068225 Metatarsals Radius Ulna Scaphoid Metacarpals SFLX 2 1068226 Humerus Tibia Fibula Radius Ulna SFLX 3 1068229 Radius Ulna Metatarsals Distal Tibia Fibula SFLX 4 1068235 Midshaft Femur Tibia Fibula Humerus SFLX 5 1068224 Femur Proximal or Mid Shaft NOTE Given certai...

Page 21: ...cific placement instructions and a Flexion Gauge for measuring the tolerances of the coil The coil should not be flexed beyond the Flex Range of the gauge the area indicated by green color Flexion Gauge Instructions for SFLX 1 SFLX 2 SFLX 3 SFLX 4 and SFLX 5 Treatment Coils In order to ensure proper fit and efficacious treatment the Flexion Gauge should be employed to check for the proper shape 1 ...

Page 22: ...nt coil strap s may be loosened to allow the coil to be adjusted and centered as required to cover the fracture nonunion site Tighten the straps again to finish the adjustment Casted Applications 1 Apply one to two rolls of casting material synthetic or plaster in the usual manner and allow it to set Center the SFLX Treatment Coil over the fracture nonunion site confirming correct placement with a...

Page 23: ...et EBI Bone Healing System The maximum recommended therapeutic treatment period is nine months approximately 270 days When the Control Unit reaches system endpoint the signal is locked SYSTEM ENDPOINT CALL BIOMET will appear on the LCD display The display will then turn OFF This message will appear every time the Control Unit is turned ON At this point the system should be disposed of in an enviro...

Page 24: ...RNING Never dispose of control unit in a fire because it contains a permanently installed battery which could explode Warning Note Type BF Equipment Direct Current Alternating Current Attention See Instructions Non ionizing Radiation Class II Single Patient Use Single Prescription WEEE Do not dispose of this device with household waste Charge Battery Reset Backlight On Off Rx Only Prescription Onl...

Page 25: ...tromagnetic Fields Science 184 575 577 1974 C A L Bassett S N Mitchell L Norton N Caulo and S R Gaston Electromagnetic Repairs of Non Unions Electrical and Magnetic Control of Musculoskeletal Growth and Repair C T Brighton ed Grune and Stratton New York 1979 C A L Bassett S N Mitchell and S R Gaston Treatment of Ununited Tibial Diaphyseal Fractures With Pulsing Electromagnetic Fields Journal of Bo...

Page 26: ...Coil 1068229 SFLX 3 Coil 1068235 SFLX 4 Coil 1068236 SFLX 4 1 Coil 1068237 SFLX 4 4 Coil 1068224 SFLX 5 Coil 1068238 SFLX Coilette 1068239 SFLX Mini Coilette 1068240 SFLX XL Coilette 1068210 Cable Zero Inch RP 1068215 Cable 28 RP 1068223 Cable 48 1068313 Black Velcro Strapping For SFLX Treatment Coilette 1068314 Black Velcro Strapping For SFLX Treatment Coilette Clavicle Application 1068317 Intern...

Page 27: ...t emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected The Biomet EBI Bone Healing System is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Group 1 RF Emissions CISPR 11 RF Emissions CIS...

Page 28: ...m be powered from an uninterruptible power supply UPS 6 kV contact 8 kV air 3 A m 2 kV for power supply lines 1 kV for input output lines 1 kV for differential mode 2 kV for common mode 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Electrostatic Discharge ESD IEC 610004 2 Electrical Fast Transient Burst IEC 610004 4 Pow...

Page 29: ...r the user of the Biomet EBI Bone Healing System should assure that it is used in such an environment NOTE 1 At 80 MHz and 800 MHz the higher frequency applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellul...

Page 30: ...nsmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 150 MHz to 2 5 GHz d 3 5 P d 3 5 P 35 35 d 7 P 01 1 1 1 1 7 1 3 5 3 5 2 21 1 11 06 11 06 7 10 35 35 70 22 13 100 Separation Distance Meters According to Frequency of Transmitter 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 Biome...

Page 31: ...d 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: ... 51 multiple procedures for services performed on the same day or at the same session by the same provider Reimbursement Coding Note CPT 20974 Electrical Stimulation to Aid Bone Healing Non Invasive CPT Code 20974 is considered to be a minor procedure with a global day 000 designation A Biomet Stimulator has been applied as follows Patient________________________________ Fracture Fusion Site______...

Page 33: ...31 Notes ...

Page 34: ...32 Notes ...

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Page 36: ...apers EXPERIENCE Recognized as an industry pioneer with EBI lineage Biomet has helped over one million people 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 tradema...

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