EBI Bone Healing System® - Model 2001
Contents
1. Transportation and storage temperature range WEEE Do not discard with household waste Si 49 Non ionizing Radiation 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 The following information is necessary to expedite any requests Patient name e Physician name e Where to send replacement items patient home MD office etc Available component parts See following page C A L Bassett Robert J Pawluk and A A Pilla Augmentation and Bone Repair by Inductively Coupled Electromagnetic 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 Bone and Joint Surgery Vol 63 4 pp 511 523 April 1981 C A L Bassett S N Mitchell and S R Gaston Pulsing Electromagnetic Field Treatment in Ununited Fractures and Failed Arthodeses Journal of the American Med2. 53 54 Flexion Gauge Instructions for FLX Flexible Treatment Coilette Clavicle 55 e Phalange Coil Application Instructions for the FLX Mini 56 e Flexion Gauge Instructions for FLX Mini Golil 56 EBI Bone Healing System FLX Mini Coilette Instructions 57 az 111 UU E P EDO 58 Flexion Gauge Instructions for the FLX Standard Coilette 59 Coil Application Instructions for the FLX Standard 59 62 9 0001 63 CLEANING INSTRUC 64 TREATMENT COMPLE ne aia a 64 DISPOSAL ING FRUC TON LLULLU LU LLULLU brani 64 80111511 1 CDA SEG 65 SYNBOL DESCRIPTION err 65 ORDERING INFORMATION 66 RERE RENGE 66 REPLACEMENT GOMPONENTS n kk kak k ya A 67 ELECTROMAGNETIC GOMPATIBILITY j j UU LJ LH E I IKKKX 68 71 QUESTIONS AND ANSWERS nn n 72 13 EBI Model 2001 Bone Healing System Model 2001 a
3. Allow six to twelve weeks for the progression of trabecular bridging with the counterproductive effects of tensile loading Fuzziness at the fracture gap will be noted radiographically FRACTURE HEALING IN RESPONSE TO PEMFs e Unlike fresh fractures the healing of nonunions treated with pulsing electromagnetic fields PEMFs does not involve external callus formation Rather the healing is more endosteal or inside out with the changes occurring within the fracture gap tissues and in the adjacent bone ends The bone healing process typically progresses in the following manner under PEMF treatment e Triggering calcification of the fibrocartilage in the fracture gap is an early PEMF effect Radiographically this calcification is evidenced by the appearance of fuzziness in the gap space The fuzziness varies in amount and rate of appearance Concurrently new blood vessels penetrate the calcified fibrocartilage and the sclerotic bone flanking the gap begins to resorb sclerolysis These effects are normally observed approximately one to three months after treatment is initiated NOTE This early healing may be disrupted by injudicious loading and motion due to inadequate immobilization FRACTURE HEALING IN RESPONSE TO cont d he 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 con
4. Coilette Gauge Saddle Shape see specifications above Place the Coilette over the red portion of the gauge marked saddle The Coilette bend should not exceed the saddle curve on the FLX Coilette Gauge 62 Front View FLEXION GAUGE wn U FLEXIBLE TREATMENT COIL 60086 COIL SPECIFICATIONS FLX Coilette Depth of Vertical Fracture Shape Penetration Length Fe 2em _ 102266 00 Rev 10 09 Back View FLEXION GAUGE LUM SU FLEXIBLE TREATMENT COIL COILETTE C 0086 A Not to scale 63 CLEANING INSTRUCTIONS THE 2001 SYSTEM The controller and charger can be cleaned by wiping with a damp cloth and mild soap Do not immerse in water or use solvents or other cleaning agents Do not machine dry FLX COILS FLX coils are not sterile Clean with mild soap and water by wiping with a damp cloth Do not immerse in water or any liquid TREATMENT COMPLETION Treatment should not be suspended until healing occurs or your physician recommends that you discontinue use of the device The device is programmed to deliver 400 consecutive days of treatment The maximum recommended treatment period is 9 months See SYSTEM ENDPOINT 400 DAYS Page 17 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 havi
5. 24 28 FLX 1 1 OR 2 1 OR 4 1 LONG VERTICAL FRACTURE APPLICATION 29 Coil Application Instructions 29 Flexion Gauge Instructions for FLX 1 1 FLX 2 1 amp 4 1 Coils 30 dg NETS 21529 FLA 1 2 2 2 Metatarsal ADDIICAPIOD 34 SCO uu u u u 34 Flexion Gauge Instructions for FLX 1 2 8 FLX 2 2 Goils 99 52312411 20110 36 37 FLX 1 3 OR 2 3 CLAVICLE APPLICATION eene 30 Flexion Gauge Instructions for FLX 1 3 amp FLX 2 3 Goils 39 e Flexion 40 41 FLX 2 4 AND 4 4 ANKLE ELBOW 42 Flexion Gauge Instructions for FLX 2 4 amp FLX 4 4 Goils 44 xia 5411 45 FLX 2 5 OR 3 5 OR 4 5 PROXIMAL HUMERUS SHOULDER APPLICATION 46 e Flexion Gauge Instructions for FLX 2 5 FLX 3 5 amp FLX 4 5 Coils 47 aC 49 49 TABLE OF CONTENTS ANKLE APPLICATION FLX XL Coilette een 50 HAND APPLICATION FLX XL Collette 51 FLX XL Flexion Gauge I aa 52 CLAVICLE PLACEMENT APPLICATION INSTRUCTIONS
6. Maximum FLX 3 Minimum Maximum S 33 33 33 33 FLX 3 5 Minimum Shoulder Maximum FLX 4 Minimum Maximum Co ON ON CO OH ON SN BOD NARA FLX 4 1 Minimum Elliptical Maximum FLX 4 4 Minimum Ankle Maximum FLX 4 5 Minimum Shoulder Maximum rEX 5 Minimum Femur Maximum 18 opecialty 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 NOTE Not all coils need to have straps switched Fracture Type Specialty Coil Type Long Vertical Fractures FLX 1 1 or 2 1 or 4 1 Metatarsals FLX 2 1 or 2 2 Clavicle FLX 1 3 or 2 3 Ankle Elbow FLX 2 4 or 4 4 Proximal Humerus Shoulder FLX 2 5 or 3 5 or 4 5 Coil Application Instructions for the FLX 1 FLX 2 FLX 3 FLX 4 and FLX 5 Coils Applies to Assembly Description Coil Replacement Suggested Placement 5001 FLX 1 0100 Metatarsals Radius Ulna Scaphoid Metacarpals 5210 FLX 2 0200 Humerus Tibia Fibula Radius Ulna 5310 FLX 3 0300 Radius Ulna Humerus Metatarsals Tibia Fibula 5410 FLX 4 0400 Femur Tibia Fibula Humerus 9010 FLX 5 9900 Femur 19 Flexion Gauge Instructions for FLX 1 FLX 2 FLX 3 FLX 4 amp FLX 5 Coils In order to e
7. RECHARGE BATTERY and 10 short beeps will sound After 10 seconds the beep RECHARGE BATTERY will stop and the display will shut off 2 Until the batteries are recharged Alternates with RECHARGE BATTERY will appear on the display each time the control unit is turned on After the third time PLEASE CALL EBI the patient turns the unit on without 1 800 526 2579 recharging RECHARGE BATTERY will appear and alternate with PLEASE CALL EBI 1 800 526 2579 If patients need assistance with recharging they Should call the 800 number and ask to speak to a Patient Support Representative Outside the United States contact your local EBl 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 4 When the control unit has been fully charged it may be removed for ambulatory treatment or left in the battery charger cradle and turned on for nonambulatory use NOTE Every 14 days the charger will automatically refresh the batteries by completely depleting them before it begins REFRESH charging When this occurs the control unit display will read REFRESHING Once the system has refreshed the batteries the control unit display will read CHARGING and the charging process Will begin The refresh mode will take a few hours depending on the size of the CHARGING FLX Flexible Treatmen
8. SAFEGUARDS amp GONTENTS Inside Front Cover TABLE OF CONTENT n y vad k ka xwa ka w sa 1 EB DON HEALING A 3 N s RTT 3 3 OPE COMPONENTS u isi i i A salak dal kal n kk dank ba 4 FULL PRESCRIBING INFORMATION L 5 5 Contraindications Warnings U klrin dareke delese ean 5 Precautions Adverse Effects kk kk kK Ka KK Ke K 6 anda aa FO RENE 6 Fracture Healing in Response to PEMFS 7 OPERATING INSTRUC 1 0 E 8 17 ell T Dal RACINE 0 9 e STEP 2 Preparing the System to Begin Treatmeni 10 STEPS and Gat DI 11 STEP Recharging the iH aac 11 13 15 e TROUBLESHOOTING SYSTEM MESSAGES 15 17 FLA FLEXIBLE TREATMENT I l lu 18 e FLX 1 FLX 2 FLX 3 FLX 4 and FLX 5 Coil Application Instructions 19 20 e Conforming the FLX 21 s Casted el ES TOT SNNT 22 e Noncasted Applications 23 V PISO 00 5 HH HH Jp pJ J o n
9. SPAN MIN 9 cm MAX 13 cm MAXIMUM DEPTH OF PENETRATION 65cm 55cm MAXIMUM FRACTURE LENGTH Tem 6cm 102867 01 Rev 10 09 Back View 4 5 6 7 8 9 C E N M E T E R S 10 FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 1 60086 FLX 1 A FLEX RANGE Not to scale 24 Front View FLEXION GAUGE Parsippany 11 07054 FLEXIBLE TREATMENT COIL www biomet com FLX 2 FLX 2 5 FLX 2 2 C 0086 FLX 22 COIL TOLERANCES FLEX SPAN MIN 8 cm MAX 11 cm MAXIMUM DEPTH OF PENETRATION MAXIMUM FRACTURE LENGTH 10cm 10cm 102867 02 Rev 10 09 Back View C E N M E T E R 5 FLEXION GAUGE MER FLEXIBLE TREATMENT COIL www biomel com FLX 2 FLX 2 5 60086 i FLX 2 4 FLEX RANGE A Not to scale 25 Front View NJ 07054 FLEXIBLE TREATMENT COIL www biomet com FLX 3 C 0086 3 5 COIL TOLERANCES FLEX SPAN MIN 5 cm MAX 9 cm MAXIMUM DEPTH OF PENETRATION MAXIMUM FRACTURE LENGTH 7 cm 102867 03 Rev 10 09 Back View C E M E T E R S ROVEST i FLEXIBLE TREATMENT COIL Parsippany NJ 07054 B www biomet com FLX 3 C 0086 FLX 3 5 FLEX RANGE 26 Not to scale Front View FLEXION GAUGE LIAME FLEXIBLE TREATMENT COIL Www noni Eom FLX 4 FLX 4 4 60086 FLX 4 4 COIL T
10. 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 NOTE Included in each system is 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 DEPTH OF PENETRATION SPECIFICATIONS FOR FLX FLEXIBLE TREATMENT COILS 1 2 3 4 5 AND COILETTE COILS TOLERANCES FLX Coil M L Flexion Depth of Vertical Fracture Penetration Length 3 FLX Mini Coilette Minimum 2 5cm Phalangeal Maximum 3 5cm oon 33 FLX Coilette Flat N A Small bones Elliptical N A Saddle N A oo ooo FLX XL Flat Coilette saddle Tea TON 808 886 Ses S22 C C CD 33 333 333 FLX 1 Minimum Scaphoid Maximum FLX 1 1 Minimum Elliptical Maximum 33 MN oo 33 FLX 1 2 Minimum Metatarsal Maximum FLX 1 3 Minimum Clavicle Maximum FLX 2 Minimum Maximum 33 33 FLX 2 1 Elliptical Maximum FLX 2 2 Minimum Metatarsal Maximum FLX 2 3 Minimum Clavicle Maximum FLX 2 4 Minimum Ankle Maximum o3 33 33 3 SO amp 3835 33 FLX 2 5 Minimum Shoulder
11. Used for right or left clavicle fracture applications NOTE Coil comes pre assembled for right clavicle applications only For left clavicle applications unsnap the two straps on the pre assembled coil and switch them Position coil on clavicle over fracture site Bring long strap diagonally across according to physician instructions the back and then around to the front Position coil with cable toward waist across the chest Press strap onto Make sure coil is firmly in place before Velcro hook Dotted line represents securing straps alternate placement of long strap Short strap is then positioned under the Cut excess straps to size arm and brought around to the front Attach short strap to the coil by pressing strap onto Velcro hook Readjust both long and short straps for a secure comfortable fit DO NOT over tighten 38 Flexion Gauge Instructions for FLX 1 3 amp FLX 2 3 Coils In order to ensure proper fit and efficacious treatment the Flexion Gauge should be checked for the proper shape 1 Place the coil at the treatment site and shape for best fit Coil should be bent only in one direction Do not kink or twist the coil 2 Remove the shaped coil and place edge closest to the connector cable into the Slot notch on the right hand side of the Flexion gauge marked with a green triangle Move the gauge through the open middle of the coil until the opposite coil edge touches the gauge again The coil e
12. and bottom straps around length according to physician instructions back to opposite side Position coil with cable toward waist Make sure coil is firmly in place before securing straps Press strap onto Velcro hook Readjust Cut excess straps to size both straps for a secure comfortable fit DO NOT over tighten 29 Flexion Gauge Instructions for FLX 1 1 FLX 2 1 amp FLX 4 1 Coils In order to ensure proper fit and efficacious treatment the Flexion Gauge should be checked for the proper shape 1 Place the coil at the treatment site and shape for best fit Coil should be bent only in one direction Do not kink or twist the coil 2 Remove the shaped coil and place edge closest to the connector cable into the Slot notch on the right hand side of the Flexion Gauge marked with a green triangle The opposite coil edge should fall within the green zone in the area marked FLEXION RANGE Each Flexion Gauge has a chart of coil tolerances with depth of penetration data 3 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 30 Front View FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATMENT COIL www biomet com 1 1 C 0086 COIL TOLERANCES FLEX SPAN MIN 8 cm MAX 10 cm MAXIMUM DEPTH OF PENETRATION Sem m MAXIMUM
13. the control unit off and leave it connected to the battery charger cradle to continue charging the batteries if it is not displaying FULLY CHARGED STEP 4 RECHARGING THE BATTERIES The average daily treatment time supplied by the batteries in the control unit will vary according to the size of FLX coil being used All coils should deliver a minimum treatment time of ten hours per charge except the FLX 5 which will deliver five hours of treatment per charge At room temperatures 24 C 75 F charging may take up to two hours In warm temperatures 29 C 85 F the unit may take up to five hours to charge After daily treatment patients should do the following A Turn the control unit off B Follow instructions A E from Step 1 Pages 8 amp 9 C It is not necessary to disconnect the control unit from the charger cradle once fully charged The control unit can remain in the battery charger cradle until the patient s next treatment session NOTE The batteries cannot be overcharged If the control unit is in the battery charger cradle and the batteries are already fully charged the charger will terminate the recharging process early This will be indicated by the control unit display reading FULLY CHARGED when charging is complete Therefore do not be concerned if the batteries are inadvertently charged more than once 11 When the batteries need recharging the following will occur 1 The display will read
14. unit from the battery CHARGING When the control unit charger cradle The control unit is now is fully charged the display will read ready for connection to the link cable and FULLY CHARGED The EBI Bone Healing treatment coil System Stimulator is now ready for daily treatment 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 end of the link cable to the FLX Flexible Treatment Coil This connection allows for simple quick disconnect and reconnect by the patient Next position the FLX Flexible Treatment Coil over the fracture site The entire fracture site should be centered within the coil treatment window 10 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 Turn the control unit on 2 Follow instructions A E from Step 1 Page 8 NOTE If treating while the control unit is connected to the battery charger cradle the control unit display Will read TREATING 00 00 and CHARGING Once the patient has TREATING 00 00 completed the treatment he should AND CH ARGING turn
15. Authorized European Representative Biomet UK Ltd Waterton Industrial Estate Bridgend CF31 3XA UK C 0086 100 Interpace Parkway Parsippany NJ 07054 800 526 2579 www biomet com 10680121 Rev B 2010 EBI LLC All trademarks are the property of Biomet Inc or its subsidiaries unless otherwise indicated Velcro is a registered trademark of Velcro Industries B V Rx Only EBI Bone Healing System Model 2001 IMPORTANT SAFEGUARDS READ ALL INSTRUCTIONS BEFORE USING When using electrical products basic safety precautions should always be followed including WARNING To reduce the risk of electric shock fire or potential injury 1 Do not use while bathing 2 Do not place or store product where it can fall or be pulled into a tub or sink 3 Do not immerse the control unit coil battery charger power unit or the battery charger cradle in any liquid 4 Do not reach for a product that has fallen into a liquid Unplug from the wall outlet immediately 9 Do not permit the battery charger to be connected when wet 6 Do not drop the control unit coil battery charger power unit or the battery charger into any liquid 7 Avoid touching the battery contacts when the battery charger cradle is plugged into an outlet 8 Do not place the battery charger cradle in the bed with you if you are using the unit while you are sleeping 9 Never operate this product if it has a damaged link cable cord or plug If
16. FRACTURE LENGTH 12cm 12 A 102867 11 Rev 10 09 Back View 2 3 4 6 7 5 C E N T I M E T E R S GAUGE 2 FLEXIBLE TREATMENT COIL C 0086 FLEX RANGE A 31 Not to scale Front View 6 7 8 C E N T E R 5 FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 2 FLEX RANGE A Back View LTS T FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATMENT COIL www biomet com FLX 2 1 C 0086 COIL TOLERANCES FLEX SPAN MIN 10 cm 12 MAXIMUM DEPTH OF PENETRATION Sem 45cm MAXIMUM FRACTURE LENGTH 16cm 14cm 102867 21 Rev 10 09 Not to scale 32 Front View 5 6 7 8 9 10 11 12 13 14 C E N T I M E T E R S FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATMENT COIL www biomet com C 0086 FEX ed FLEX RANGE A Back View FLEXION GAUGE Parsippany 07054 FLEXIBLE TREATMENT COIL FLX 4 1 COIL TOLERANCES FLEX SPAN MIN 12 cm MAX 14 cm MAXIMUM DEPTH OF PENETRATION 102867 41 Rev 10 09 Not to scale 33 Coil Application Instructions Applies to Assembly Description Coil Replacement Suggested Placement 5112 FLX 1 2 0102 Metatarsals Cuniform Cuboid 5212 FLX 2 2 0202 Metatarsals Cuniform Cuboid FLX 1 2 2 2 METATARSAL APPLICATION See Flexion Gau
17. OLERANCES FLEX SPAN MIN 925em MAX 1480 ry WAXMUNDERTROFRENETRATON _ waxMUMFRACTURELENGTH 2em sem 102867 04 Rev 10 09 Back View C E N T I M E T E FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATMENT COIL www biomet com C 0086 T OP FLX 4 5 A 14 50 cm Not to scale 21 Front View FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATM ENT COIL www biomet com 60086 COIL TOLERANCES MAXIMUM DEPTH OF PENETRATION 12 100m MAXIMUM FRACTURE LENGTH 10cm 10cm P N 102867 05 Rev 10 09 Back View rt ce TW TT TT TT TT TT TT PT TT TT TT TT T TT TT T 0 1 2 3 4 5 6 7 8 9 10 Ti 12 13 14 15 16 17 18 19 20 21 c E N T 1 E T E R 5 FLEXION GAUGE 7 FLEXIBLE TREATMENT COIL C 0086 FEK A Not to scale 28 Coil Application Instructions Applies to Assembly Description Coil Replacement Suggested Placement 9111 FLX 1 1 0101 Radius Ulna Malleolus M L 5211 FLX 2 1 0201 Tibia Fibula Radius Ulna 5411 FLX 4 1 0401 Humerus Tibia Fibula Radius Ulna FLX 1 1 OR 2 1 OR 4 1 LONG VERTICAL FRACTURE APPLICATION oee Flexion Gauge Instructions for measuring the tolerances of the coil on page 31 33 Used for long vertical fracture lengths comminuted and segmented fracture applications Position coil so that it covers the entire fracture Bring top
18. ON RANGE Each Flexion Gauge has a chart of coil tolerances with depth of penetration data 3 Ifthe 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 47 Front View iyan ELEMION Gauice Parsippany NJ 07054 FLEXIBLE TREATMENT COIL www biomet com 3 C 0086 FLX 3 5 COIL TOLERANCES FLEX SPAN MIN 5 cm MAX 9 cm MAXIMUM DEPTH OF PENETRATION E MAXIMUM FRACTURE LENGTH 7 cm 102867 03 Rev 10 09 Back View C E T I M E T E R 5 E EIE FLEXIBLE TREATMENT COIL Parsippany NJ 07054 u www biomet com FLX 3 C 0086 FLX 3 5 FLEX RANGE Not to scale 48 Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL arsippany NJ 07054 www biomet com FLX 4 C 0086 FLX 4 4 COIL TOLERANCES MAXIMUM DEPTH OF PENETRATION 10em s 102867 04 Rev 10 09 Back View C E N T I M E T E FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATMENT COIL www biomet com FLX 4 C 0086 FLX 4 4 FLX 4 5 A 14 50 cm Not to scale 49 Coil Application Instructions For FLX XL Coilette Applies to Assembly Description Coil Replacement Suggested Placement 5620 FLX XL 5700 Foot Ankle Hand Wrist Coilette ANKLE APPLICATION Center the coi
19. a CANNOT CHARGE hardware problem within the charger The message will stay on the display for 10 seconds Alternates with and then turn off each time the control unit is turned on After the third time of turning the unit on without correcting the problem PLEASE CALL EBI CANNOT CHARGE will appear and alternate 8111 826 with PLEASE CALL EBI 1 800 526 2579 1 800 920 2979 If you need assistance you should call the 800 i number and ask to speak to a Patient Support Until 3rd time Representative Outside the United States contact your local EBI Biomet Distributor or call 1 973 299 9300 SYSTEM ENDPOINT 400 DAYS PLEASE CALL EBI 1 800 526 2579 When the control unit reaches 400 days of SYSTEM ENDPOINT treatment the treatment signal is locked off 400 DAYS The display will read SYSTEM ENDPOINT 400 DAYS followed by PLEASE CALL EBI 1 800 Alternates with 526 2579 The display will turn off This message will appear every time the control unit is turned on At this point the system should be PLEASE CALL EBI discarded Itis 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 EBl Biomet Distributor or call 1 973 299 9300 17 FLX FLEXIBLE TREATMENT COILS The FLX Flexible Treatment Coil included with this EBI Bone Healing System
20. all 5315 FLX 3 5 0305 Humerus Proximal Medium 5415 4 5 0405 Humerus Proximal Larger FLX 2 5 OR 3 5 OR 4 5 PROXIMAL HUMERUS SHOULDER APPLICATION See Flexion Gauge Instructions for measuring the tolerances of the coil on page 47 Used for proximal humerus shoulder applications Position coil over the proximal humerus Bring the long strap diagonally fracture site according to physician across the back and then around to instructions Position coil with cable the front across the chest Press toward waist Make sure coil is firmly strap onto Velcro hook in place before securing straps second strap is then positioned under the Readjust both straps for a secure arm and brought around to the front comfortable fit DO NOT over tighten Attach strap to the coil by pressing strap before cutting excess straps to size onto Velcro hook 46 Flexion Gauge Instructions for FLX 2 5 3 5 amp FLX 4 5 Coils In order to ensure proper fit and efficacious treatment the Flexion Gauge should be checked for the proper shape 1 Place the coil at the treatment site and shape for best fit Coil should be bent only in one direction Do not kink or twist the coil 2 Remove the shaped coil and place edge closest to the connector cable into the slot notch on the right hand side of the Flexion Gauge marked with a green triangle The opposite coil edge should fall within the green zone in the area marked FLEXI
21. applied directly to the skin A spe Cific electrical current is delivered to the coil by the control unit The coil then delivers the ther apeutic electromagnetic signal to the nonunion fracture site GROUNDING PLUG This product is equipped with a grounding plug with the exception of the Model 2001E The battery charger power unit should be plugged into a wall outlet that is properly installed and grounded In the event of an electrical short circuit grounding reduces the risk of electric shock by providing an escape wire for the electric current If it is necessary to use an extension cord use an extension cord that has a 3 blade grounding plug and a 3 slot receptacle that will accept the plug on the product Do not use damaged cords D Not for use by patients who are pregnant or becoming pregnant Not recommended for patients with certain types of pacemakers or implantable defibrillators 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 D BMP 2 and BMP 4 which are normal physiological regulators of the various stages of bone healing including angiogenesis chondrogenesis and osteogenesis INDICATIONS FOR USE The EBI Bone Healing System Stimulator is indicated for the treatment of fracture nonunions failed fusions and congenital pseudarthrosis in the appendicular system A no
22. ber if the treatment is administered longer than the prescribed amount ten hours the additional time cannot be applied for future days Example If you used the system for multi ple sessions totaling 14 hours one day you should not abbreviate the next day s cumulative treatment time to six hours For your convenience your daily treatment time is displayed continuously in hours and minutes After ten hours of treatment the display will read 10 00 and beep three 3 times and then shut off automatically 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 2 Insert the control unit firmly into the battery charger cradle to recharge the batteries for your next treatment See BATTERY CHARGING 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 For Prescription Use Only The EBI Bone Healing System Stimulator is a durable therapeutic electrical device intended for single patient use only under a prescription Treatment at home or in another appropriat
23. ce of the interference as indicated in table 4 Table 1 Guidance and manufacturer s declaration electromagnetic emissions 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 RF emissions Group 2 CISPR 11 RF emissions Class B CISPR 11 Harmonic emissions Not applicable IEC 61000 3 2 Voltage fluctuations Not applicable flicker emissions IEC 61000 3 3 68 Electromagnetic environment guidance The Model 2001 Bone Healing System must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected The Model 2001 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 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 IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact Floors should be wood concr
24. dge should fall within the green zone in the area marked FLEX RANGE Each Flexion Gauge has a chart of coil tolerances with depth of penetration data 3 Ifthe 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 39 Front View FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATMENT COIL C 0086 ms COIL TOLERANCES MAXIMUM DEPTH OF PENETRATION MAXIMUM FRACTURE LENGTH 5 24 102867 13 Rev 10 09 Back View FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATMENT COIL www biomet com C 0086 gt 120 150 NOTCH A N SEA O Not to scale 40 Front View FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATMENT COIL www biomet com FLX 2 3 C 0086 COIL TOLERANCES FLEX SPAN MIN 120 MAX 150 MAXIMUM DEPTH OF PENETRATION MAXIMUM FRACTURE LENGTH 8 8 102867 23 Rev 10 09 Back View FLEXION GAUGE 2 FLEXIBLE TREATMENT COIL C 0086 FLX 2 3 NOTCH A TREATMENT WINDOW Not to scale 41 Coil Application Instructions for FLX 2 4 and FLX 4 4 Coils Applies to Assembly Description Coil Replacement Suggested Placement 5214 FLX 2 4 0204 Ankle 0414 FLX 4 4 0404 Ankle Lar
25. e 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 35 Front View e FLEXION GAUGE 2 FLEXIBLE TREATMENT COIL C 0086 Ed FLX 1 2 COIL TOLERANCES FLEX SPAN MIN 9 cm MAX 13 cm MAXIMUM DEPTH OF PENETRATION 65cm 55cm MAXIMUM FRACTURE LENGTH Tem 102867 01 Rev 10 09 Back View 4 5 6 7 8 9 C E N M E T E R 5 10 11 FLEXION GAUGE Parsippany NJ 07054 Www biome com FLEXIBLE TREATMENT COIL FLX 1 C 0086 FLX 1 A FLEX RANGE Not to scale 36 Front View GOYET FLEXION GAUGE FLEXIBLE TREATMENT COIL 7 FLX 2 FLX 2 5 60086 FLX 2 2 FLX 2 4 COIL TOLERANCES FLEX SPAN MIN 8 cm MAX 11 cm MAXIMUM DEPTH OF PENETRATION MAXIMUM FRACTURE LENGTH 10cm 10cm 102867 02 Rev 10 09 Back View FLEXION GAUGE EET FLEXIBLE TREATMENT COIL FLX 2 FLX 2 5 C 0086 Eod FLX 2 4 FLEX RANGE Not to scale 37 Coil Application Instructions Applies to Assembly Description Coil Replacement Suggested Placement 9113 FLX 1 3 0103 Clavicle 5213 FLX 2 3 0203 Clavicle Larger FLX 1 3 OR 2 3 CLAVICLE APPLICATION see Flexion Gauge Instructions for measuring the tolerances of the coil on pages 40 41
26. e or similar setting is acceptable The device cannot be reprocessed i e disinfected sterilized etc with the intent to be used by another patient or for treatment other than prescribed RECOMMENDED CONCURRENT FRACTURE MANAGEMENT The EBI Bone Healing System Stimulator works best when motion of the fracture site is minimized or nonexistent For most patients this immobilization is achieved by applying a well molded plaster or synthetic cast at the beginning of treatment together with initial non weight bearing if it is the lower extremity The following methods of fracture immobilization have been most effective e ankle tarsals metatarsals short leg cast or rigid internal fixation tibia long leg cast short leg cast with rigid fixation or stable internal fixation or external fixation shoulder clavicle brace or abduction splint or internal fixation or figure 8 immobilization humerus stable internal fixation and or adequate immobilization with controlled rotation scaphoid wrist long arm cast with thumb spica short arm cast with rigid fixation or stable internal fixation carpals metacarpals phalanges cast or internal fixation or external fixation WEIGHT BEARING GUIDELINES Immediate weight bearing is recommended for stable fractures less than five degrees of motion in any plane and or stable internal fixation Initial non weight bearing is recommended for unstable fractures greater than five degrees of motion
27. eatment the Flexion Gauge should be checked for the proper shape 1 Place the coil at the treatment site and shape for best fit Coil should be bent only in one direction Do not kink or twist the coil 2 Remove the shaped coil and place edge closest to the connector cable into the slot notch on the right hand side of the Flexion Gauge marked with a green triangle The opposite coil edge should fall within the green zone in the area marked FLEXION RANGE Each Flexion Gauge has a chart of coil tolerances with depth of penetration data 3 Ifthe 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 4 4 Coil Flexion Gauge Refer to page 25 for a diagram of the FLX 2 4 Coil Flexion Gauge 44 Front View FLEXION GAUGE FLEXIBLE TREATMENT COIL Parsippany NJ 07054 www biomet com FLX 4 C 0086 FLX 4 4 COIL TOLERANCES MAXIMUM FRACTURE LENGTH 102867 04 Rev 10 09 Back View C E N M E T E FLEXION GAUGE Parsippany NJ 07054 FLEXIBLE TREATMENT COIL www biomet com C 0086 FLX 4 FLX 4 4 FLX 4 5 CABLE A Y 14 50 cm FLEX RANGE Not to scale 45 Coil Application Instructions For FLX 2 5 3 5 4 5 Applies to Assembly Description Coil Replacement Suggested Placement 5215 FLX 2 5 Humerus Proximal Sm
28. ed below The customer or the user of the Model 2001 Bone Healing System should assure that it is used in such an environment IEC 60601 Compliance ectromagnetic environment test level level guidance Portable and mobile RF communications equip ment should be used no closer to any part of the Model 2001 Bone Healing System including cables than the recommended separation dis tance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 1 354 IEC 61000 4 6 1 354 80 MHz to 800 MHz where P is the maximum power output rating of IEC 61000 4 3 80 MHz to 2 5 the transmitter in watts W according to the GHz transmitter manufacturer and d is the recom mended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equip ment marked with the following symbol 9 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 cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be pr
29. edict ed theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Model 2001 Bone Healing System is used exceeds the applicable RF compliance level the Model 2001 Bone Healing System should be observed to verify normal operation If abnormal perfor mance is observed additional measures may be necessary such as reorienting or relocating the Model 2001 Bone Healing System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 1 V m 70 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 Rated maximum Separation distance meters according to frequency of transmitter output power of transmitter 150 kHz to 80 MHz 80 MHz 10 800 MHz 800 MHz to 2 5 GHz For transmitters rated at a maximum output po
30. elry Front View RDOXE FLX FLEXIBLE MINI TREATMENT GAUGE www biomet com C 0086 COIL TOLERANCES MAXIMUM DEPTH OF PENETRATION 25cm 20cm MAXIMUM FRACTURE LENGTH A 106123 Rev 10 09 Back View 0 1 2 3 4 5 6 7 8 N T 1 R S i FLX FLEXIBLE Parsippany NJ 07054 MINI TREATMENT GAUGE C 0086 3 5 2 5cm A Not to scale 98 Coil Application Instructions for the FLX Standard Coilette Applies to Assembly Description Coil Replacement Suggested Placement 5610 Standard 0600 Metatarsals Scaphoid Distal Radius Coilette Cuboid M L Malleous Flexion Gauge Instructions for FLX Standard Coilette In order to ensure proper fit and efficacious treatment the Flexion Gauge should be checked for the proper shape 1 Place the treatment coil at the treatment site and shape for best fit The treatment coil must only be bent in one of two directions Long or short axis see illustrations that follow Do not kink or twist the treatment coil The shape of the treatment coil will determine the specifications 2 Remove the shaped treatment coil and utilize the Flexion Gauge to verify the acceptable bend according to the shape listed below 3 Ifthe treatment coil edge does not fall within the green zone contact your Biomet representative for a suitable replacement and assistance Optional Shapes Flat Fl
31. es where internal fixation devices such as rods or pins already exist Question What is the usual healing time with this system Answer Since the EBI Bone Healing System Stimulator triggers the bone healing process the treatment period is similar to that expected following the surgical procedures for problem fractures Your physician will determine the length of the treatment period based on the progress of your fracture Your compliance with the recommended ten 10 hours per treatment is very important A review of the clinical data demonstrates that less than the recommended use of the device possibly results in an increase in the time to heal your fracture 790002 5012 Question Is the treatment as effective as surgery Answer The success rate using the EBI Bone Healing System Stimulator is comparable to surgical results without the risk associated with surgery 72 10 11 12 13 14 Question Is the cost of treatment covered by health insurance Medicare or Medicaid Answer While the individual policies may differ in their coverage most private insurance companies health plans or workers compensation plans have approved treatment with the EBI Bone Healing System Stimulator Coverage is also provided by Medicare and Medicaid Question What will feel during treatment Answer The EBI Bone Healing System Stimulator should produce no sensations during its use Should you have any questions contact Bio
32. ete or discharge ESD ceramic tile If floors are covered 8 kV air with synthetic material the relative IEC 610004 2 humidity should be at least 309 Electrical fast 2 kV for power Mains power quality should be that of transient burst supply lines a typical commercial or hospital environment IEC 61000 4 4 1 kV for input output lines Surge 1 kV for Mains power quality should be that of differential mode a typical commercial or hospital IEC 61000 4 5 environment 2 kV for common mode Voltage dips lt 5 U Mains power quality should be that of short gt 95 dip in Ur a typical commercial or hospital interruptions and for 0 9 cycle environment If the user of the Model voltage varia 40 U 2001 Bone Healing System requires tions on 60 dip in Uy continued operation during power power supply for 5 cycles mains interruptions it is input lines recommended that the Model 2001 7096 U Bone Healing System be powered IEC 61000 4 11 30 dip in U from an uninterruptible power supply for 25 cycles UPS lt 5 Ur gt 95 dip in U for 9 sec Power frequency Power frequency magnetic fields should 50 60 Hz be at levels characteristic of a typical magnetic field location in a typical commercial or hospital environment IEC 61000 4 8 69 Table 3 uidance and manufacturer s electromagnetic immunity The Model 2001 Bone Healing System is intended for use in the electromagnetic environment specifi
33. exion Gauge not required Elliptical Place treatment coil over green portion of Flexion Gauge The coil bend should not exceed the curve indicated on this Flexion Gauge Saddle Place the treatment coil over the red portion of the Flexion Gauge The coil bend should not exceed the curve indicated on this Flexion Gauge 99 FLX STANDARD COILETTE FLEXIBLE TREATMENT COIL Foot Application For System Assembly 5610 and Coilette 0600 snap Dual Velcro Straps with 2201 E 0 Attach the FLX Standard Center the FLX Standard Wrap lower strap around Coilette to the strap by Coilette over the fracture site bottom of foot and attach connecting it to the Velcro to Velcro hook hook provided on the strap Wrap top strap around ankle Adjust strap for comfort and cable and attach to Excess strap length may then be cut away Velcro hook When treatment is completed for the day remove the FLX Standard Coilette by loosening the straps Leave the straps attached to the Coilette It is ready for your next daily treatment 60 FLX STANDARD COILETTE FLEXIBLE TREATMENT COIL Hand Application For System Assembly 5610 and Coilette 0600 Shape and place the FLX Standard Coilette over the treatment site as instructed by your physician or Biomet representative Secure Velcro straps onto the Velcro hook Adjust for comfort FLA Dual Velcro Straps with Velcro ho
34. ext daily treatment 94 Flexion Gauge Instructions for FLX Flexible Treatment Coilette Clavicle In order to ensure proper fit and efficacious treatment the Flexion Gauge should be checked for the proper shape 1 Place the coil at the treatment site and shape for best fit The FLX Coil must only be bent in one of two directions Long or short axis see illustrations that follow Do not kink or twist the coil The shape of the coil will determine the specifications 2 Remove the shaped coil and utilize the Flexion Gauge to verify the acceptable bend according to the shape listed below 3 Ifthe coil edge does not fall within the green zone contact your Biomet representative for a suitable replacement and assistance Optional Shapes Flat Flexion Gauge not required Elliptical Place treatment coil over green portion of Flexion Gauge The treatment coil bend should not exceed the curve indicated on this Gauge saddle Place the treatment coil over the red portion of the Flexion Gauge The coil bend should not exceed the curve indicated on this Flexion Gauge Refer to page 63 for a diagram of the Flexion Gauge 99 Coil Application Instructions for the FLX Mini Applies to Assembly Description Coil Replacement Suggested Placement 5630 FLX Mini 5650 Phalanges Flexion Gauge Instructions for FLX Mini Coil In order to ensure proper fit and efficacious treatment the Flexion Gauge should be checked
35. for the proper shape 1 Place the coil at the treatment site and shape for best fit Treatment coil should be bent only in one direction Do not kink or twist the coil 2 Remove the shaped treatment coil and place edge closest to the connector cable into the slot notch on the right hand side of the Flexion Gauge marked with a green triangle The opposite treatment coil edge should fall within the green zone in the area marked FLEX RANGE Each Flexion Gauge has a chart of coil tolerances with depth of penetration data 3 Ifthe treatment coil edge does not fall within the green zone contact your Biomet representative for a suitable replacement and assistance Refer to page 58 for a diagram of the Flexion Gauge 96 Bone Healing System FLX Mini Coilette Instructions Slip wrist Adjust strap up connector strap or down arm around wrist until length of wire to FLX Mini Coilette is properly placed b Trim excess strap with 50165015 Feeding strap through ring adjust and tight en securing strap to Velcro hook Secure FLX Mini Coilette in place by wrapping strap around finger and Securing onto Velcro hook i Adjust FLX Mini Coilette to size by Squeezing or Opening Trim excess strap with scissors Connect EBI Bone Healing System Stimulator link cable to wrist connector by inserting plug into jack Begin treatment Warning Do not place FLX Mini Coilette over metallic splints or jew
36. ge 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 The FLX 1 2 and FLX 2 2 treatment coils have a foam overlay on the exterior of the coil that permits a Velcro patch face to open through the window in the treatment coil Conform the treatment coil to securely fasten the treatment coil by the metatarsal site pressing on the back of the Velcro patch within the center of the treatment coil No trimming or readjusting is required 34 Flexion Gauge Instructions for FLX 1 2 amp FLX 2 2 Coils In order to ensure proper fit and efficacious treatment the Flexion Gauge should be checked for the proper shape 1 4 Place the coil at the treatment site and shape for best fit Coil should be bent only in one direction Do not kink or twist the coil Remove the shaped coil and place edge closest to the connector cable into the slot notch on the right hand side of the Flexion Gauge marked with a green triangle The opposite coil edge should fall within the green zone in the area marked FLEXION RANGE Each Flexion Gauge has a chart of coil tolerances with depth of penetration data After verifying the coil shape is within the green zone affix the foam backing to the coil via the snaps at each corner The Velcro strap should be exposed through the coil window facing the treatment site If the coil edg
37. ger FLX 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 NOTE Position coil with cable toward waist Make sure coil is firmly in place before securing straps Position coil over the fracture site at the back of the ankle for ankle application or over the elbow for elbow application according to physician instructions Make certain the coil is flush with the bottom of the foot or centered over the elbow Make sure coil is firmly in place before securing straps 42 23 E EW n d 4 m 4 9 m m 4 E P u N n m Ta E Lo Ji E Straps are then positioned over the front of the ankle or elbow Readjust both straps for a secure comfortable fit opposite the Velcro hook before cutting excess straps to size DO NOT over tighten Optional for ankle application only If the coil migrates upward you may use the additional Strap provided to secure the coil Simply fasten one end of the strap to the medial inside seam Side of the ankle bring strap under the foot and back around to the lateral side outside side of ankle Fasten strap into place by pressing strap onto Velcro hook 43 Flexion Gauge Instructions for FLX 2 4 amp FLX 4 4 Coils In order to ensure proper fit and efficacious tr
38. ical Association Vol 247 No 5 pp 623 628 February 5 1982 C A L Bassett Pulsing Electromagnetic Fields A New Method to Modify Cell Behavior in Calcified and Non Calcified Tissue Calcified Tissue Int Vol 34 No 1 1 8 1982 Model 2001 BHS Replacement components Applies to Description Part Number Coil FLX 1 0100 Coil FLX 1 1 0101 Coil FLX 1 2 0102 Coil FLX 1 3 0103 Coil FLX 2 0200 Coil FLX 2 1 0201 Coil FLX 2 2 0202 Coil FLX 2 3 0203 Coil FLX 2 4 0204 Coil FLX 2 5 0205 Coil FLX 3 0300 Coil FLX 3 5 0305 Coil FLX 4 0400 Coil FLX 4 1 0401 Coil FLX 4 4 0404 Coil FLX 4 5 0405 Coil FLX 5 5500 Coil Standard Coilette 0600 Coil Clavicle Coilette 0603 Coil Mini Coilette 5650 Coil XL 5700 Controller 106 223 00 Charging Cradle 1067223 01 67 ELECTROMAGNETIC COMPATIBILITY he use of accessories and cables other than those supplied may result in increased emissions or decreased immunity of the equipment or system e his equipment should not be used adjacent to or stacked upon other equipment e Portable and mobile RF communications equipment can adversely affect the operation of Medical Electrical Equipment n the event this equipment interferes with the operation of other equipment or experiences interference from other equipment to continue treatment it will be necessary to move the Model 2001 Bone Healing System away from the sour
39. ies to Assembly Description Coil Replacement Suggested Placement 5613 FLX 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 Coilette and straps to be fitted over the effected torso and shoulder Place the coilette and straps provided on a flat surface The straps are provided snapped together Notice that the strap with Velcro is longer than the one without Velcro Excess cable strap a Wrap the long strap with Velcro b Note The snap should be located around your chest and back onto itself in the center of your back secure it in place with the Velcro 53 TS Pull the remaining short strap from behind your back over the shoulder on the Place the FLX Secure the Coilette over the Coilette in place treatment site by passing the strap over the M Velcro on the Coilette and 4 onto the chest strap Close the chest strap as instructed by your physician or Biomet representative b Common position a Adjust for comfort Excess shoulder and chest strap lengths may be then cut away When treatment is completed for the day remove the coil by unhooking the strap from around your chest Leave the strap over your shoulder secured to the coil and chest strap Remove the coil It is ready for your n
40. ing does not appear satisfactory Some commonly asked questions about the EBI Bone Healing System Stimulator 1 N I Question What is the EBI Bone Healing System Stimulator and how does it promote healing Answer The EBI Bone Healing System Stimulator is an effective method for promoting the healing of fractures that have not mended spontaneously The system consists of a treatment coil which is incorporated into a cast on top of a cast or brace or placed directly on to the skin The control unit delivers a therapeutic electric current to the treatment coil at the fracture site Many events occur at the time of fracture to promote healing Among them are your body s own natural electrical currents However if these natural electrical currents are interrupted healing may become problematic The therapeutic electrical current produced by the EBI Bone Healing System Stimulator is very similar to the currents that the body produces naturally to signal the bone to begin healing in the first few weeks after your fracture Just as you are unaware of the electrical currents produced by your own body you may not be aware of the therapeutic electrical current produced by the EBI Bone Healing System Stimulator Question Is the system safe Answer The system has been widely used because of its proven success and absence of any known risks It does not require surgery has no known side effects and is effective even in fractur
41. is of the tibia Treatment with pulsing electromagnetic fields Clinical Orthop 154 136 149 1981 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 Stimulator ADVERSE EFFECTS None known DIRECTIONS FOR USE Follow the treatment schedule prescribed by your doctor normally ten 10 hours per day Your compliance with the recommended ten 10 hours per day treatment is very important A review of the clinical data demonstrates that less than the recommended use of this device possibly results in an increase in the time to heal your fracture P790002 S01 2 If you are unable to treat for ten continuous hours it is recommended that you break up the total treatment time into more than one session You should Turn the control unit off when finished with your session e When ready to resume treating turn the control unit on The display will indicate the treatment time you have completed and keep track of your cumulative treatment time for the day f you do not finish ten hours in that day then use the RESET button to return the time to zero See RESET BUTTON Remem
42. it is not working properly if it has been dropped and damaged or dropped into any liquid Return the product to EBI 10 Keep all cords away from heated surfaces 11 Never insert any object into any opening of the system 12 Do not place the control unit or the battery charger in prolonged heat or direct sunlight Normal operating temperature range is 0 to 38 32 F to 100 F normal storage transport temperature is 15 C to 45 C 5 F to TIS FD 13 Connect this product to a properly grounded outlet See GROUNDING INSTRUCTIONS 14 Use this product only for its intended use as described in this manual 15 Medical Electrical Equipment needs special precautions regarding 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 9 3 299 9300 with any questions or problems Outside the United States contact your local EBl Biomet Distributor SAVE THESE INSTRUCTIONS Contents Model 2001 Control Unit Recharger Power Supply FLX Treatment Coil with straps if applicable User Manuals 2 Connector cables FLX Gauge Belt and Pouch if applicable Travel Card Recharger base Carrying Case Caution Federal Law U S A restricts this device to sale by or on the order of a physician For Prescription Use Only TABLE OF CONTENTS IMPORTANT
43. k cable in the carrying bag for the best device protection Question turned the control unit on and the display reads RECHARGE BATTERY Do have to wait or can use the system now Answer You may treat with the system while it is charging but before it is fully recharged Leave the control unit connected to the battery charger Make sure the control unit is on This is called treating and recharging at the same time The display will read TREATING 00 00 AND CHARGING 73
44. l over the fracture site Wrap lower strap around bottom of Conform the coil and verify with gauge foot and attach to Velcro hook Wrap upper strap around ankle and Adjust straps for comfort Excess cable Attach to Velcro hook strap length may be cut away When treatment is complete for the day remove the coilette by loosening the straps 90 Coil Application Instructions For FLX XL Coilette Applies to Assembly Description Coil Replacement Suggested Placement 5620 FLX XL 5700 Foot Ankle Hand Wrist Coilette WRIST APPLICATION Center the coilette over the fracture site secure upper proximal strap first Conform shape and remove Verify coil is Wrap strap around hand and attach conformed within treatment limit with to Velcro hook Flexion gauge secure lower distal strap by wrapping Adjust straps for comfort When around fracture site and attaching to treatment is complete for the day Velcro hook Cut away excess strap length remove the coilette by loosening the straps 91 Front View FLX FLEXIBLE TREATMENT XL COILETTE GAUGE Parsippany NJ 07054 www biomet com C 0086 COIL SPECIFICATIONS FLX Coilette Depth of Vertical Fracture Shape Penetration Length Saddle 5 5 cm 106109 Rev 10 09 Back View DOZE Parsippany NJ 07054 www biomet com C 0086 A 2 52 Not to scale Coil Application Instructions Appl
45. met Question How many hours per day will 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 Question Can the EBI Bone Healing System Stimulator be used if become pregnant Answer Use of the Bone Healing System on pregnant patients has not been evaluated therefore it is not recommended in these cases lf you become pregnant notify your physician immediately Question s there any danger in wearing the treatment coil if have a pacemaker or defibrillator Answer The unit is not recommended to be used with certain types of demand pacemakers or implantable defibrillators or in close proximity to a person with a pacemaker or defibrillator Question If extend the number of treatment hours per day will it reduce the number of days required to heal my fracture Answer No increasing the daily number of treatment hours beyond ten hours per day will not reduce the overall length of time to heal your fracture Question Are there any side effects Answer None are known Question Can use an extension cord with the battery charger unit Answer Yes See GROUNDING PLUG PAGE 4 Question What is the best way to store and transport the system travel a good deal and will be carrying the EBI Bone Healing System Stimulator with me Answer It is recommended that you store and transport the control unit battery charger the lin
46. nd FLX Flexible Treatment Coil Caution Federal Law U S A restricts this device to sale by or on the order of a physician For Prescription Use Only Single prescription Single patient use Not for re sale re use or re distribution DESCRIPTION The EBI Bone Healing System Stimulator promotes healing by inducing weak pulsing electrical currents at the nonunion fracture site These signals are generated by a low energy electromagnetic field created by passing specific electrical current pulses through a flexible treatment coil Electrical Requirements of Model 2001 Power Unit USA Americas Input 120V u 60Hz 36W Output 17 8V 1 5 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 Ving 11111 mmt awa m L tum BULL ER j Model ZI BEW EEE nput JV JAZ oW eee c ME Model 2001J mpt TV X 9Uz 1100 JUTU L i mur am for TEY TR TT TT SYSTEM COMPONENTS CONTROL UNIT The EBI Bone Healing System Stimulator control unit operates on nickel metal hydride rechargeable batteries which allow for ambulatory use The control unit contains the operating electronics programmed for the FLX Flexible Treatment Coil It includes an audible and visible self checking alarm mechanism to alert the patient if the unit is not functioning prope
47. ng difficulty with the operation of your EBI Bone Healing System Stimulator please contact the Quality Assurance Department 1 973 299 9300 follow prompts to Product Support NOTE Only defective units may be returned to Biomet Units that have passed through their system endpoints or that have previously delivered a complete prescribed treatment must be disposed of properly see Disposal Instructions DISPOSAL INSTRUCTIONS The Stimulator control unit AC adapter link cables FLX Treatment Coil cradle and battery are regulated and should be properly disposed of or recycled according to local statutes and regulations Please contact your local recycling center for instructions and procedures to safely dispose of the EBI Bone Healing System Stimulator 64 EQUIPMENT CLASSIFICATION Models 2001 2001A 2001J 20010 Class Type B Models 2001E Class 11 Type B e Ordinary equipment without protection against ingress of water e Equipment not suitable for use in presence of flammable anaesthetic mixture with air or with oxygen or with nitrous oxide Mode of operation continuous SYMBOL DESCRIPTION Type B n Class II Manufacturer Direct Current Not recommended for Catalog Number patients with certain types pregnant Not for use by patients who are pregnant or becoming N Alternating Current of pacemakers or implantable Serial Number defibrillators Attention See Instructions
48. nly appear during a treatment session In order to recharge the batteries and continue treatment ensure that the control unit is on Refer to Step 4 RECHARGING THE BATTERIES P 11 repeating 1 4 RECHARGE BATTERY 19 CHECK CONNECTORS SEE MANUAL This message accompanied by 10 short audible beeps appears when the control unit is not CHECK CONNECTORS Treatment Coil Be sure to check all connections SEE MANUAL properly connected to the FLX Flexible between the control unit link cable and the Alternates with treatment coil If the connection is not made the unit will turn itself off When the unit is turned back on and the message continues PLEASE CALL EBI check all connections again If the problem is OND FOR not corrected and the connection is not made 000 920 20 9 the message will stay on the display for 10 seconds and then turn off each time the control unit is turned on After the third time of turning the unit on without correcting the problem CHECK CONNECTORS SEE MANUAL will appear and alternate with 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 This message accompanied by ten short audible CHECK COIL beeps appears when the FLX Flexible Treatment Coil is damaged or inappropriatel
49. nsure proper fit and efficacious treatment the Flexion Gauge should be checked for the proper shape 1 Place the coil at the treatment site and shape for best fit Coil should be bent only in one direction Do not kink or twist the coil 2 Remove the shaped coil and place edge closest to the connector cable into the slot notch on the right hand side of the Flexion Gauge marked with a green triangle The opposite coil edge should fall within the green zone in the area marked FLEXION RANGE Each Flexion Gauge has a chart of coil tolerances with depth of penetration data 3 Ifthe 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 20 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 The coil is designed to be bent in only one direction single plane see illustration It should not be twisted or kinked FLX COIL APPLICATIONS It is necessary that the entire fracture site receive a therapeutic pulsing field This is accomplished by placing the treatment coil over the fracture site Ensure that the entire fracture is centered within the t
50. nunion is considered to be established when there are no visibly progressive signs of healing The original 1979 PMA study included 146 patients with nonunion fractures These difficult fractures were characterized as follows 2 3 average number of prior surgeries and an average of thirty seven months median twenty months since original injury These patients were followed for a minimum of four years average seven years from the date of treatment termination with a success rate of 63 5 Even though long term follow up requirements were 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 Bassett who defined the tibial lesions as Type 0 6 Type II n 19 and Type III n 18 with Type being the most severe and recalcitrant to treatment The success rate for Bassett Type lesions was 66 7 Bassett Type II lesions 57 9 and Bassett Type 111 lesions 22 2 The long term post treatment follow up for the congenital pseudarthrosis study patient population 48 was to skeletal maturity or the age of 18 The study had an 87 5 follow up rate A Nonunion fractures which a synovial pseudarthrosis fluid filled gap exists B Under certain conditions electromagnetic stimulation could inhibit the output of some demand pacemakers or implantable defibrillators Therefore it is not recommended for patients
51. oks J Cable Place the FLX Standard Coilette over treatment site and bring straps around each side of thumb uu Place the FLX9 Standard Coilette onto the Velcro hook on the strap 9 n When treatment is completed for the day remove the FLX Standard Coilette by loosening the straps Leave the straps attached to the FLX Standard Coilette It is ready for your next daily treatment Excess strap length may then be cut away 61 FLX Flexible Treatment Coilette Specifications and Gauge Directions FLX Coilette Shape Depth of Penetration Vertical Fracture Length Hat 2 5 cm 4 cm Elliptical 3 5 cm 4 cm Saddle 3 5 cm 2 cm To insure efficacious treatment with the FLX Coilette Coil 1 Place the Coilette on the treatment site and shape for best fit The Coilette must only be bent in one of two directions long axis or short axis see illustrations Do not kink or twist the Coilette 2 The shape of the Coilette will determine the coil specifications see above 3 Remove the Coilette and utilize the enclosed FLX Coilette Gauge to verify the shape listed below Optional Shapes Flat Shape see coil specifications above The FLX Coilette Gauge is not needed Elliptical Shape see coil specifications above Place the Coilette over the green portion of the gauge marked elliptical The Coilette bend should not exceed the elliptical curve indicated on the FLX
52. reatment coil window The coil is designed to permit routine follow up examination by x ray 21 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 Position the connector mounting assembly near the coil and incorporate it into the cast with additional cast material SPECIAL NOTE If patient compliance with the system is not a concern the treatment coil may be placed on top of a cast or brace Be sure to mark the coil placement with an indelible marker for easy refitting by the patient 22 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 Attach and secure the FLX coil around the extremity with the Velcro strap or the garment to give the patient a snug yet comfortable fit NOTE To allow flexibility in positioning the treatment coil was designed with a large treatment window However it is recommended that the center of the coil be positioned over the fracture site 23 Front View FLEXION GAUGE 7 FLEXIBLE TREATMENT COIL C 0086 COIL TOLERANCES FLEX
53. rly The control unit is designed to store the patient s daily usage information Patients are encouraged to bring the control unit and treatment coil to each follow up visit to allow the prescribing physician to review their treatment regimen NOTE The control unit may be worn comfortably on a belt or the waist using the Belt Pouch when the patient is ambulatory BATTERY CHARGER CRADLE The battery charger cradle is powered by the battery charger power unit adaptor and is designed to recharge the control unit batteries Its design also allows the control unit to be used in a treat and charge situation i e while sleeping sitting See TREATING AND CHARGING STEP 3 pg 11 BATTERY CHARGER POWER UNIT The battery charger power unit is powered by normal house current and is designed to provide power to the charger cradle Power unit must be unplugged from wall outlet to be disconnected LINK CABLE The link cable connects the control unit to its FLX Flexible Treatment Coil The link cable supplied is a 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 FLX FLEXIBLE TREATMENT COIL The FLX Flexible Treatment Coil is an encased wire coil that may be incorporated into a cast over a cast or brace or when a cast is not utilized may be
54. t Coil being used 12 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 EBI RECOMMENDS 10 HOURS PER DAY for the 2001 BHS 2 AVG HR DAY 00 00 This is the daily treatment average since the patient s treatment started 3 DAYS USED 000 This is the total number of days of treatment 4 DAYS UNUSED 000 This is the total number of days when there was no treatment 5 TREATING 00 00 This is the cumulative number of hours of treatment in the present or previous treatment session provided that the reset button has not been pressed see RESET BUTTON EBI RECOMMENDS 10 HOURS PER DAY 5 PATIENT USAGE AVG HR DAY 00 00 PATIENT USAGE DAYS USED 000 4 PATIENT USAGE DAYS UNUSED 000 TREATING 0 00 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 The treatment time will be retained on the display unless the RESET button is depressed for two audible beeps To avoid
55. the accidental reset of the daily time the RESET button has a one second delay When pressed the RESET button will beep To clear the time back to zero continue holding the button until a second beep is heard approximately one second Release the RESET button This will clear the time back to 0 00 The display will then read TREATING 0 00 TREATING 0 00 BACKLIGHT BUTTON The system is designed with a backlight function to enhance the visibility of the LCD display in dim lighting When pressed the BACKLIGHT button will beep and the backlight will turn on for 5 seconds 14 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 N Insert the control unit firmly into the battery charger cradle to recharge the batteries for your next treatment See BATTERY CHARGING 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 TROUBLESHOOTING SYSTEM MESSAGES Allow up to one minute for the display message to change after taking corrective action e RECHARGE BATTERY If this message appears the batteries need to be recharged This message will o
56. tinuity occurs in all cortices as visualized on AP and lateral x rays Once cortical continuity is established and clinical union occurs i e no motion the PEMFs treatment may be discontinued These effects are normally observed approximately three to eight months after treatment is initiated At this point the patient should be put on a program of guarded rehabilitation to prevent refracture e Subsequent remedullarization and remodeling occurs according to Wolff s Law and may take from twelve to twenty four months to complete OPERATING INSTRUCTIONS Before using the EBI Bone Healing System Stimulator for the first time the control unit Should be charged STEP 1 BATTERY CHARGING The EBI Bone Healing System Stimulator runs on nickel metal hydride batteries Before treating with the system the patient will need to charge the batteries to a full charge At room temperatures 24 C 175 charging may take up to two hours In warm temperatures 29 C 85 F the unit may take up to five hours to charge Plug the battery AC charger power unit Attach battery AC charger power unit to into a grounded wall outlet the battery charger cradle A green light on the cradle will Place the control unit into the battery illuminate indicating that the charger charger cradle as illustrated Make sure is connected to household power the control unit is turned off FULLY CRARGED The control unit display will read Remove the control
57. wer not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for 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 71 QUESTIONS AND ANSWERS This section has been prepared to answer some of the questions most frequently asked about the 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 0 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 Bone is one of the tissues of the human body with the ability to mend itself when injured in much the same way as skin and other tissues can After a break bone repair processes usually assure a sound union within a few months Occasionally however the formation of new bone is slow and the break fails to heal properly Medically prescribed use of the EBI Bone Healing System Stimulator by a physician can often promote healthy bone growth and repair in cases when normal heal
58. with certain types of pacemakers or implantable defibrillators Patients should be cautioned to avoid coming in close proximity to pacemaker or defibrillator wearers during stimulation C Use of the EBI Bone Healing System Stimulator on pregnant patients has not been evaluated therefore it is not recommended in these cases The long term effects of exposure low level magnetic fields not known Routine use of The EBI Bone Healing System Stimulator for over 20 years has indicated no known risks B During the treatment of patients with open epiphyses when the epiphysis is in the pulsing field physicians are advised that the epiphyseal growth plates should be monitored for possible effects C Use of the EBI Bone Healing System Stimulator for spine and skull has not been evaluated D To reduce the risk of potential injury 1 AVOID touching the battery charger contacts when the battery charger is plugged into a wall outlet 2 DO NOT place the battery charger in bed if treating while sleeping E The control unit and battery charger are electrically live when connected together and the battery charger is plugged into an outlet To reduce the risk of serious injury by electric shock patients are advised 1 DO NOT permit the battery charger to be connected when wet 2 DO NOT immerse the control unit the coil or the battery charger in water or any liquid Bassett CAL N Caulo and J Kort Congenital pseudarthros
59. y flexed The SEE MANUAL message will stay on the display for 10 seconds and then turn off each time the control unit is Alternates with turned on After the third time of turning the unit on without correcting the problem CHECK COIL SEE MANUAL will appear and alternate with PLEASE CALL EBI PLEASE CALL EBI 1 800 526 2579 lf you 1 800 526 2579 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 CANNOT TREAT PLEASE CALL EBI 1 800 526 2579 This message accompanied by ten short audible beeps appears when there is a hardware CANNOT TREAT problem within the control unit The message will stay on display for 10 seconds and then turn Alternates with off each time the control unit is turned on After the third time of turning the unit on without correcting the problem CANNOT TREAT will PLEASE CALL EBI appear and alternate with PLEASE CALL EBI 1 800 526 2579 1 800 526 2579 f you need assistance you should call the 800 number and ask to speak to a Patient Support Representative Outside the United otates contact your local EBl Biomet Distributor or call 1 973 299 9300 16 CANNOT CHARGE PLEASE CALL EBI 1 800 526 2579 This message accompanied by 10 short audible beeps appears when temperature is over 38 degrees C under 0 degrees C or there is
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