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BIOMET EBI Bone Healing System User Manual

BIOMET EBI Bone Healing System
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The Biomet
®
EBI Bone Healing System
Physician Manual and Package Insert
English Language
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
trademarkofVelcroIndustriesandVelcroUSAInc.RxOnly.PrescriptionOnly-SingleUseOnly-
NotforRe-saleorRe-Distribution-DoNotReuse

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BIOMET EBI Bone Healing System Specifications

General IconGeneral
CategoryMedical Equipment
TechnologyPulsed Electromagnetic Field (PEMF)
FDA ApprovalYes
Power SupplyBattery
DimensionsVaries by model
Signal TypePulsed
Stimulation TypeNon-invasive

Summary

Important Safeguards and Contents

System Components

Control Unit – Controller

Describes the control unit, its battery, programming, alarms, and patient compliance features.

SFLX Flexible Treatment Coil

Describes the SFLX Flexible Treatment Coil, its construction, application methods, and signal delivery.

Full Prescribing Information

Indications for Use

Specifies the fracture nonunions, failed fusions, and congenital pseudarthrosis indications for the system.

Contraindications

Lists contraindications such as synovial pseudarthrosis and potential interference with medical devices.

Warnings

Highlights warnings regarding long-term magnetic field exposure, open epiphyses, spine/skull use, and electrical safety.

General Treatment Instructions

Recommended Usage

Advises a daily treatment dosage of 10 hours and emphasizes compliance for optimal healing.

Operating Instructions

Step 1: Battery Charging

Explains the process for fully charging the control unit's lithium ion battery before the first use.

Battery Safety Warning

Lists critical warnings about handling the permanently installed lithium ion battery and the control unit.

Step 2: Preparing the System to Begin Treatment

Details connecting the link cable and positioning the SFLX Flexible Treatment Coil over the nonunion site.

Step 3: Treating and Charging

Provides instructions for patients to treat with the system while the battery is recharging.

Step 4: Recharging the Battery

Outlines the procedure for recharging the controller's battery after completing a daily treatment session.

Keypad Functions

Troubleshooting System Messages

SFLX Treatment Coils

Depth of Penetration Specifications

Details penetration specifications, flexion, and anatomical locations for various SFLX treatment coils.

Application Instructions for SFLX Coils

Provides application instructions and suggested anatomical placements for specific SFLX treatment coils (1-5).

Conforming and Applying the SFLX Treatment Coil

Details how to shape and apply the SFLX Treatment Coil to effectively cover the fracture nonunion site.

Casted and Noncasted Applications

Biomet® EBI Bone Healing System Components

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