Electromagnetic Compatibility (EMC) and needs to be operated according to the EMC information provided in this instruction manual. NOTE: Call the Biomet Patient Support Department in New Jersey between 8:30 a.m. and 6:30 p.m. Eastern Time at 1-973-299-9300 with any questions or problems. Outside the United States contact your local EBI/Biomet Distributor.
TABLE OF CONTENTS IMPORTANT SAFEGUARDS & CONTENTS ........Inside Front Cover TABLE of CONTENTS....................1 EBI BONE HEALING SYSTEM ® Stimulator..............3 • Description ......................3 • Electrical Requirements ..................3 SYSTEM COMPONENTS ....................4 FULL PRESCRIBING INFORMATION ................5 • Indications For Use ....................5 • Contraindications, Warnings ..................5 •...
60Hz 36W Output: 17.8V 1.5A. Do not use any other power unit with the Model 2001 Bone Healing System. ELECTRICAL REQUIREMENTS Use the following power adapters with the Model 2001 Bone Healing System. Model 2001A Australia Input: 240V 50Hz Output: 17.8V...
33” (83.8cm) cable. Link cables are also available in 12” and 48” lengths. For either a 12” (30.5cm) or 48” (121.9cm) cable, phone the Biomet Patient Support Department at 1-973-299-9300. Outside the United States contact your local EBI/Biomet Distributor.
FULL PRESCRIBING INFORMATION The mechanism of action behind the PEMF technology involves the upregulation of factors that modulate normal bone healing. PEMF increases a number of factors such as TGF- ß BMP-2 and BMP-4, which are normal physiological regulators of the various stages of bone healing, including angiogenesis, chondrogenesis and osteogenesis.
PRECAUTIONS The following conditions may compromise a successful treatment outcome. A. Nonunion fractures with gaps in excess of 1 cm. B. Presence of fixation devices made from magnetic materials. (Most presently used internal or external fixation devices are constructed of 316L S.S., titanium alloys, and cobalt-chromium alloys which are non-magnetic and, therefore, compatible with the EBI Bone Healing System ®...
The EBI Bone Healing System ® Stimulator may be used at home or at work. Your schedule and lifestyle will determine the best time for using the system. Many people find it convenient to treat while they are sleeping. • EBI Pre Market Approval Data (P790002/S012) NOTE: This is a single patient use device, do not reuse.
FRACTURE HEALING IN RESPONSE TO PEMFs (cont’d) • The second stage of healing is indicated by the appearance of consolidated bone stress lines that bridge the fracture gap. This bridging may appear initially, but should progress until cortical continuity occurs in all cortices as visualized on AP and lateral x-rays.
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Place the control unit into the battery A green light on the cradle will charger cradle as illustrated. Make sure illuminate indicating that the charger the control unit is turned off. is connected to household power. CHARGING FULLY CHARGED The control unit display will read Remove the control unit from the battery “CHARGING”.
STEP 2: PREPARING THE SYSTEM TO BEGIN TREATMENT The link cable arrives disconnected from the control unit. Connect one end of the link After confirming that the link cable is properly cable to the control unit cable connected to the control unit, connect the other as illustrated.
STEP 3: TREATING AND CHARGING Patients may treat with the system while recharging the batteries. When the patient treats and charges at the same time, the treatment time and charging message will be displayed. To treat and charge, patients should: 1.
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800 number and ask to speak to a Patient Support Representative. Outside the United States contact your local EBI/Biomet Distributor, or call 1-973-299-9300. 3. Only after the patient places the control unit into the battery charger cradle for recharging will the message automatically clear.
KEYPAD FUNCTIONS ON/OFF BUTTON Each time the ON/OFF button is pressed, an audible beep will be heard. To turn the control unit on, press the on/off button one time. Pressing this button a second time will turn the system off. Every time the control unit is turned on, the display will indicate the following sequence: 1.
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RESET BUTTON The system is designed with a reset function to allow the daily timer to be reset to zero. Should the patient not finish the ten hours of treatment in one day, he/she presses the RESET button for two (2) beeps and the daily timer will go back to zero in preparation for the next treatment session.
Following completion of your daily treatment, you should do the following: 1. Make sure the control unit is off. If you have completed 10 hours, the unit will automatically shut off. With less than 10 hours of treatment, you will need to manually turn the control unit off.
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“PLEASE CALL EBI 1-800-526-2579”. If you need assistance, you should call the 800 number and ask to speak to a Patient Support Representative. Outside the United States contact your local EBI/Biomet Distributor, or call 1-973-299-9300. ”CHECK COIL SEE MANUAL”...
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It is recommended that you contact 1-800-526-2579 your Doctor’s office to inform him/her that you have reached this point in your treatment. See p.64 for Disposal Instructions. Outside the United States contact your local EBI/Biomet Distributor, or call 1-973-299-9300.
Flexible Treatment Coil included with this EBI Bone Healing System ® Stimulator was specifically chosen by Biomet based upon the location of the fracture, the vertical length of the fracture, the depth of signal penetration required to treat the fracture, and the anatomical size of the patient.
Specialty coils are for applications where the standard straps may be too difficult to apply. Each specialty FLX ® coil features one (1) snap at all four corners of the coil and comes pre-assembled to fit the right side of the body but the same straps may be easily switched for left side applications.
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“FLEXION RANGE”. Each Flexion Gauge has a chart of coil tolerances with depth of penetration data. If the coil edge does not fall within the green zone, contact your Biomet representative for a suitable replacement and assistance. Refer to pages 24-28 for diagrams of the Flexion Gauges.
CONFORMING THE FLX ® COIL The FLX ® coil is easily conformable so it may be shaped to the surface anatomy of the fracture site being treated. The coil is also rigid enough to retain its shape once conformed. The lightweight, low, flat profile makes the coil easy to apply and more comfortable for the patient to wear.
CASTED APPLICATIONS: 1. Apply 1-2 rolls of casting material (synthetic or plaster) in the usual manner and allow it to set. Center the coil over the fracture site, confirming correct placement with an x-ray if necessary. 2. Incorporate the coil into the cast with an additional wrap of casting material. 3.
NONCASTED APPLICATIONS: 1. If using the coil directly on the skin, place the foam padding inside the coil. 2. Position the FLX ® coil over the fracture site. The entire fracture site should be centered within the coil treatment window. 3.
Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL Parsippany, NJ 07054 0086 www.biomet.com FLX 1 FLX 1-2 COIL TOLERANCES MIN (9 cm) MAX (13 cm) FLEX SPAN MAXIMUM DEPTH OF PENETRATION 5.5 cm 6.5 cm 6 cm MAXIMUM FRACTURE LENGTH 7 cm 102867-01 Rev.
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Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL Parsippany, NJ 07054 0086 FLX 2 FLX 2-5 www.biomet.com FLX 2-2 FLX 2-4 COIL TOLERANCES MAX (11 cm) FLEX SPAN MIN (8 cm) 8 cm MAXIMUM DEPTH OF PENETRATION 7 cm MAXIMUM FRACTURE LENGTH...
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Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL 0086 Parsippany, NJ 07054 FLX 3 www.biomet.com FLX 3-5 COIL TOLERANCES MAX (9 cm) FLEX SPAN MIN (5 cm) MAXIMUM DEPTH OF PENETRATION 7 cm 5.5 cm MAXIMUM FRACTURE LENGTH 7 cm 6 cm 102867-03 Rev.
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Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL Parsippany, NJ 07054 0086 FLX 5 www.biomet.com COIL TOLERANCES MIN (13 cm) MAX (20 cm) FLEX SPAN MAXIMUM DEPTH OF PENETRATION 12 cm 10 cm MAXIMUM FRACTURE LENGTH 10 cm 10 cm P/N 102867-05 Rev. 10/09...
“FLEXION RANGE”. Each Flexion Gauge has a chart of coil tolerances with depth of penetration data. If the coil edge does not fall within the green zone, contact your Biomet representative for a suitable replacement and assistance. Refer to pages 31-33 for diagrams of these Flexion Gauges.
Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL 0086 Parsippany, NJ 07054 FLX 1-1 www.biomet.com COIL TOLERANCES FLEX SPAN MIN (8 cm) MAX (10 cm) MAXIMUM DEPTH OF PENETRATION 5 cm 4 cm MAXIMUM FRACTURE LENGTH 12 cm 12 cm 102867-11 Rev. 10/09...
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Front View FLEXION GAUGE 0086 FLEXIBLE TREATMENT COIL Parsippany, NJ 07054 www.biomet.com FLX 2-1 12 cm 10 cm FLEX RANGE Back View FLEXION GAUGE FLEXIBLE TREATMENT COIL 0086 Parsippany, NJ 07054 FLX 2-1 www.biomet.com COIL TOLERANCES MIN (10 cm) MAX (12 cm ) FLEX SPAN 4.5 cm...
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Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL 0086 Parsippany, NJ 07054 www.biomet.com FLX 4-1 14 cm 12 cm FLEX RANGE Back View FLEXION GAUGE FLEXIBLE TREATMENT COIL 0086 Parsippany, NJ 07054 www.biomet.com FLX 4-1 COIL TOLERANCES MIN (12 cm) MAX (14 cm)
Coil Application Instructions Applies to: Assembly # Description Coil Replacement # Suggested Placement 5112 ® 0102 Metatarsals, Cuniform Cuboid 5212 ® 0202 Metatarsals, Cuniform Cuboid ® 1-2, 2-2 METATARSAL APPLICATION See Flexion Gauge Instructions for measuring the tolerances of the coil on page 36-37. Used for metatarsal fracture applications and may be applied over a foot shoe garment or bootie.
If the coil edge does not fall within the green zone, contact your Biomet representative for a suitable replacement and assistance. Refer to pages 36 and 37 for diagrams of these Flexion Gauges.
Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL 0086 Parsippany, NJ 07054 www.biomet.com FLX 1 FLX 1-2 COIL TOLERANCES FLEX SPAN MIN (9 cm) MAX (13 cm) MAXIMUM DEPTH OF PENETRATION 6.5 cm 5.5 cm 6 cm MAXIMUM FRACTURE LENGTH 7 cm 102867-01 Rev.
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Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL 0086 FLX 2 FLX 2-5 Parsippany, NJ 07054 www.biomet.com FLX 2-2 FLX 2-4 COIL TOLERANCES MAX (11 cm) FLEX SPAN MIN (8 cm) 8 cm MAXIMUM DEPTH OF PENETRATION 7 cm MAXIMUM FRACTURE LENGTH...
Coil Application Instructions Applies to: Assembly # Description Coil Replacement # Suggested Placement 5113 ® 0103 Clavicle 5213 ® 0203 Clavicle - Larger ® 1-3 OR 2-3 CLAVICLE APPLICATION See Flexion Gauge Instructions for measuring the tolerances of the coil on pages 40-41. Used for right or left clavicle fracture applications.
“FLEX RANGE”. Each Flexion Gauge has a chart of coil tolerances with depth of penetration data. If the coil edge does not fall within the green zone, contact your Biomet representative for a suitable replacement and assistance. Refer to pages 40 and 41 for diagrams of these Flexion Gauges.
Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL 0086 Parsippany, NJ 07054 FLX 2-3 www.biomet.com COIL TOLERANCES FLEX SPAN MIN (120 ) MAX (150 ) 4 cm MAXIMUM DEPTH OF PENETRATION 4 cm MAXIMUM FRACTURE LENGTH 8 cm 8 cm 102867-23 Rev. 10/09...
Coil Application Instructions for: FLX ® 2-4 and FLX ® 4-4 Coils Applies to: Assembly # Description Coil Replacement # Suggested Placement 5214 ® 0204 Ankle 5414 ® 0404 Ankle - Larger ® 2-4 AND 4-4 ANKLE/ELBOW APPLICATION See Flexion Gauge Instructions for measuring the tolerances of the coil on page 44. Used for ankle/elbow fracture applications.
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Both top & bottom straps are then positioned over the front of the ankle or elbow. Fasten straps into place by pressing strap onto Velcro ® hook. Readjust both straps for a secure, comfortable fit opposite the Velcro ® hook before cutting excess straps to size.
“FLEXION RANGE”. Each Flexion Gauge has a chart of coil tolerances with depth of penetration data. If the coil edge does not fall within the green zone, contact your Biomet representative for a suitable replacement and assistance. Refer to page 45 for a diagram of the FLX ®...
“FLEXION RANGE”. Each Flexion Gauge has a chart of coil tolerances with depth of penetration data. If the coil edge does not fall within the green zone, contact your Biomet representative for a suitable replacement and assistance. Refer to pages 37, 48 and 49 for Flexion Gauge diagrams.
Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL 0086 Parsippany, NJ 07054 FLX 3 www.biomet.com FLX 3-5 COIL TOLERANCES MAX (9 cm) FLEX SPAN MIN (5 cm) MAXIMUM DEPTH OF PENETRATION 7 cm 5.5 cm MAXIMUM FRACTURE LENGTH 7 cm 6 cm 102867-03 Rev.
Coil Application Instructions For: FLX ® - XL Coilette Applies to: Assembly # Description Coil Replacement # Suggested Placement 5620 ® - XL 5700 Foot/Ankle, Hand, Wrist Coilette ANKLE APPLICATION Center the coil over the fracture site. Wrap lower strap around bottom of Conform the coil and verify with gauge.
Coil Application Instructions Applies to: Assembly # Description Coil Replacement # Suggested Placement 5613 ® 0603 Clavicle Coilette Clavicle CLAVICLE PLACEMENT APPLICATION INSTRUCTIONS See Conforming the Coil and Flexion gauge instructions on page 55. Components: The FLX ® Coilette Clavicle comes with a FLX ®...
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Velcro ® on the your physician Coilette and or Biomet onto the chest representative. strap. Close the chest strap. b) Common a) Adjust for position. comfort. Excess shoulder and...
Remove the shaped coil and utilize the Flexion Gauge to verify the acceptable bend according to the shape listed below. If the coil edge does not fall within the green zone, contact your Biomet representative for a suitable replacement and assistance.
“FLEX RANGE”. Each Flexion Gauge has a chart of coil tolerances with depth of penetration data. If the treatment coil edge does not fall within the green zone, contact your Biomet representative for a suitable replacement and assistance.
EBI Bone Healing System ® ® -Mini Coilette Instructions Adjust strap up Slip wrist or down arm connector strap until length around wrist. ® of wire to FLX Mini Coilette is properly placed. b) Trim excess Feeding strap strap with through ring, scissors.
Remove the shaped treatment coil and utilize the Flexion Gauge to verify the acceptable bend according to the shape listed below. If the treatment coil edge does not fall within the green zone, contact your Biomet representative for a suitable replacement and assistance.
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® -STANDARD COILETTE FLEXIBLE TREATMENT COIL Foot Application For System Assembly #5610 and Coilette #0600 Cable Dual Velcro ® Straps with snap ® Coilette ® ® Attach the FLX -Standard Center the FLX -Standard Wrap lower strap around Coilette to the strap by bottom of foot and attach Coilette over the fracture site.
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Velcro ® hook on the strap. site and bring straps over the treatment site around each side of as instructed by your thumb. physician or Biomet representative. Excess strap length may When treatment is Secure Velcro ® straps then be cut away.
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® Biomet ® Flexible Treatment Coilette Specifications and Gauge Directions ® Coilette Shape Depth of Penetration Vertical Fracture Length Flat 2.75 cm 4 cm Elliptical 3.5 cm 4 cm Saddle 3.5 cm 2 cm To insure efficacious treatment with the FLX ®...
RETURNING DEFECTIVE PRODUCT A Stimulator Control Unit, AC Adapter, Flexible Treatment Coil, or Link Cable that is defective may be returned to Biomet. To return a part, or if you are having difficulty with the operation of your EBI Bone Healing System ®...
EQUIPMENT CLASSIFICATION • Models 2001, 2001A, 2001J, 2001U Class I Type B • Models 2001E Class II Type B • Ordinary equipment without protection against ingress of water • Equipment not suitable for use in presence of flammable anaesthetic mixture with air or with oxygen or with nitrous oxide •...
ORDERING INFORMATION To order replacement coils or related components simply contact your Biomet representative or call the Biomet Patient Support Department directly at 1-800-526-2579, 8:30 a.m. to 6:30 p.m. Eastern Time Monday through Friday. Outside the United States contact your local EBI/Biomet Distributor, or call 1-973-299-9300.
ELECTROMAGNETIC COMPATIBILITY • The use of accessories and cables other than those supplied may result in increased emissions or decreased immunity of the equipment or system • This equipment should not be used adjacent to or stacked upon other equipment •...
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Table 2 Guidance and manufacturer’s declaration - electromagnetic immunity The Model 2001 Bone Healing System is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 2001 Bone Healing System should assure that it is used in such an environment.
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Table 3 Guidance and manufacturer’s declaration - electromagnetic immunity The Model 2001 Bone Healing System is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 2001 Bone Healing System should assure that it is used in such an environment.
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Table 4 Recommended separation distances between portable and mobile RF communications equipment and the Model 2001 Bone Healing System The Model 2001 Bone Healing System is intended for use in an electromagnetic environment in which radi- ated RF disturbances are controlled. The customer or the user of the Model 2001 Bone Healing System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile communications equipment (transmitters) and the Model 2001 Bone Healing System as recom- mended below, according to the maximum power output of the communications equipment.
EBI Bone Healing System Stimulator. If you have any further questions after reading it, please contact your doctor or call Biomet’s Patient Support Department at 1-800-526-2579 8:30 a.m. – 6:30 p.m. Eastern Time Monday through Friday. Outside the United States contact your local EBI/Biomet Distributor, or call 1-973-299-9300.
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Answer: The EBI Bone Healing System Stimulator should produce no sensations during its use. Should you have any questions, contact Biomet. 7. Question: How many hours per day will I have to apply the treatment coil? Answer: Follow the prescribed number of treatment hours instructed by your doctor (usually 3 to 10 hours per day).
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