BIOMET 2001A User Manual Download Page 64

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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.

Place the

FLX

-Standard

Coilette onto the

Velcro

hook on the strap.

Place the FLX

-Standard

Coilette over treatment

site and bring straps

around each side of

thumb.

Secure

Velcro

straps

onto the Velcro

hook.

Adjust for comfort.

Excess strap length may

then be cut away.

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.

Dual Velcro

Straps with

Velcro

hooks

Cable

FLX

Coilette

FLX

-STANDARD COILETTE FLEXIBLE TREATMENT COIL

Summary of Contents for 2001A

Page 1: ...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 EC REP Authorized European Representative Biomet UK Ltd Waterton Industrial Estate Bridgend CF31 3XA UK ...

Page 2: ...Non Invasive Stimulation OPTIONS EVIDENCE EXPERIENCE EBI Bone Healing System Model 2001 User Manual and Package Insert ...

Page 3: ...turn 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 C to 38 C 32 F to 100 F normal storage transport temperature is 15 C to 45 C 5 F to 113 F 13 Connect this product to a properly grounded outl...

Page 4: ...nd FLX 5 Coil Application Instructions 19 20 Conforming the FLX Coil 21 Casted Applications 22 Noncasted Applications 23 Flexion Gauges 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 FLX 4 1 Coils 30 Flexion Gauges 31 33 FLX 1 2 2 2 Metatarsal Application 34 Coil Application Instructions 34 Flexion G...

Page 5: ...xion Gauge Instructions for FLX Mini Coil 56 EBI Bone Healing System FLX Mini Coilette Instructions 57 Flexion Gauge 58 Flexion Gauge Instructions for the FLX Standard Coilette 59 Coil Application Instructions for the FLX Standard 59 62 Flexion Gauge 63 CLEANING INSTRUCTIONS 64 TREATMENT COMPLETION 64 DISPOSAL INSTRUCTIONS 64 EQUIPMENT CLASSIFICATION 65 SYMBOL DESCRIPTION 65 ORDERING INFORMATION 6...

Page 6: ...enerated 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 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 Sys...

Page 7: ...tery 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 ...

Page 8: ...Type III lesions 22 2 The long term post treatment follow up for the congenital pseudarthrosis study patient population n 48 was to skeletal maturity or the age of 18 The study had an 87 5 follow up rate CONTRAINDICATIONS A Nonunion fractures in which a synovial pseudarthrosis fluid filled gap exists B Under certain conditions electromagnetic stimulation could inhibit the output of some demand pac...

Page 9: ...session 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 If you do not finish ten hours in that day then use the RESET button to return the time to zero See RESET BUTTON Remember if the treatment is administered longer than the prescribed amount ten hours the additiona...

Page 10: ... a prescription Treatment at home or in another appropriate 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 ...

Page 11: ...onsolidated 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 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 ...

Page 12: ...tment A green light on the cradle will illuminate indicating that the charger is connected to household power Place the control unit into the battery charger cradle as illustrated Make sure the control unit is turned off Remove the control unit from the battery charger cradle The control unit is now ready for connection to the link cable and treatment coil C D E F FULLY CHARGED CHARGING ...

Page 13: ...After confirming that the link cable is properly connected to the control unit connect the other 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 A B C ...

Page 14: ...he 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 STEP 3 TREATING AND CHARGING Patients may treat with the system ...

Page 15: ...BI 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 ...

Page 16: ...HS 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 press...

Page 17: ... for two audible beeps To avoid 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 BACKLIGHT BUTTON The system is d...

Page 18: ...ATTERY 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 ...

Page 19: ...ly flexed 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 COIL 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 Un...

Page 20: ... 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 treatment the treatment signal is locked off The display will read SYSTEM ENDPOINT 400 DAYS followed by PLEASE CALL EBI 1 800 526 2579 The display will turn off This message will appear every time the control unit is turned on At this point the syst...

Page 21: ...25 cm 6 cm Saddle 7 5 cm 5 5 cm 4 cm FLX 1 Minimum 9 cm 6 5 cm 7 cm Scaphoid Maximum 13 cm 5 5 cm 6 cm FLX 1 1 Minimum 8cm 5 cm 12 cm Elliptical Maximum 10 cm 4 cm 12 cm FLX 1 2 Minimum 9cm 6 5 cm 7 cm Metatarsal Maximum 13 cm 5 5 cm 6 cm FLX 1 3 Minimum 120 3 cm 5 cm Clavicle Maximum 150 3 cm 5 cm FLX 2 Minimum 8 cm 8 cm 10 cm Maximum 11 cm 7 cm 10 cm FLX 2 1 Minimum 10 cm 5 cm 16 cm Elliptical M...

Page 22: ...LX 5 5500 Femur 19 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 NOTE Not all coils need to have straps switched Fracture Type Specialty Coil Type Lo...

Page 23: ...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...

Page 24: ...d to permit routine follow up examination by x ray 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 ...

Page 25: ... 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 refi...

Page 26: ...d 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 ...

Page 27: ...N GAUGE FLEXIBLE TREATMENT COIL FLX 1 R FLX 1 2 R FLEXION GAUGE FLEXIBLE TREATMENT COIL 13 cm 9 cm CABLE 102867 01 Rev 10 09 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 C E N T I M E T E R S Parsippany NJ 07054 FLEX RANGE www biomet com 0086 FLX 1 FLX 1 2 R Parsippany NJ 07054 www biomet com 0086 FLEX RANGE Front View Back View Not to scale ...

Page 28: ...NETRATION MAXIMUM FRACTURE LENGTH 8 cm 10 cm 7 cm 10 cm 102867 02 Rev 10 09 CABLE 11 cm 8 cm FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 2 R FLX 2 2 R FLX 2 4 R FLX 2 5 R C E N T I M E T E R S 0 1 2 3 4 5 6 7 8 9 10 11 12 FLEX RANGE Parsippany NJ 07054 www biomet com 0086 Parsippany NJ 07054 www biomet com 0086 Front View Back View Not to scale ...

Page 29: ... PENETRATION MAXIMUM FRACTURE LENGTH 7 cm 7 cm 5 5 cm 6 cm 102867 03 Rev 10 09 FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 3 R FLX 3 5 R CABLE 5 cm 9 cm 0 1 2 3 4 5 6 7 8 9 10 C E N T I M E T E R S FLEX RANGE Parsippany NJ 07054 www biomet com 0086 Parsippany NJ 07054 www biomet com 0086 Front View Back View Not to scale ...

Page 30: ...27 Front View Back View Not to scale ...

Page 31: ... 14 15 16 17 18 19 20 21 Parsippany NJ 07054 www biomet com 0086 FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 5 R COIL TOLERANCES FLEX SPAN MIN 13 cm MAX 20 cm MAXIMUM DEPTH OF PENETRATION MAXIMUM FRACTURE LENGTH 12 cm 10 cm 10 cm 10 cm P N 102867 05 Rev 10 09 P Parsippany NJ 07054 www biomet com 0086 Front View Back View Not to scale ...

Page 32: ... Used for long vertical fracture lengths comminuted and segmented fracture applications Position coil so that it covers the entire fracture length according to physician instructions Position coil with cable toward waist Make sure coil is firmly in place before securing straps Bring top and bottom straps around back to opposite side Press strap onto Velcro hook Readjust both straps for a secure co...

Page 33: ...ve 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 Bio...

Page 34: ...ppany NJ 07054 www biomet com 0086 FLEXION GAUGE Front View Back View COIL TOLERANCES FLEX SPAN MIN 8 cm MAX 10 cm MAXIMUM DEPTH OF PENETRATION MAXIMUM FRACTURE LENGTH 5 cm 12 cm 4 cm 12 cm 102867 11 Rev 10 09 FLEXIBLE TREATMENT COIL FLX 1 1 R FLEXION GAUGE Parsippany NJ 07054 www biomet com 0086 Not to scale ...

Page 35: ... 5 cm 14 cm FLEXIBLE TREATMENT COIL FLX 2 1 R FLEX RANGE 10 cm 12 cm C E N T I M E T E R S 102867 21 Rev 10 09 0 1 2 3 4 5 6 7 8 9 10 11 12 0086 Parsippany NJ 07054 www biomet com FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 2 1 R FLEXION GAUGE 0086 Parsippany NJ 07054 www biomet com Front View Back View Not to scale ...

Page 36: ...NETRATION MAXIMUM FRACTURE LENGTH 6 cm 22 cm 6 cm 18 cm 14 cm 12 cm FLEX RANGE C E N T I M E T E R S 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 102867 41 Rev 10 09 0086 Parsippany NJ 07054 www biomet com 0086 Parsippany NJ 07054 www biomet com FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 4 1 R Front View Back View Not to scale ...

Page 37: ...sal 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 the metatarsal site Securely fasten the treatment coil by pressing on the back of the Velcro patch within the center of ...

Page 38: ...f 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 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...

Page 39: ...N GAUGE FLEXIBLE TREATMENT COIL FLX 1 R FLX 1 2 R FLEXION GAUGE FLEXIBLE TREATMENT COIL 13 cm 9 cm CABLE 102867 01 Rev 10 09 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 C E N T I M E T E R S Parsippany NJ 07054 FLEX RANGE www biomet com 0086 FLX 1 FLX 1 2 R Parsippany NJ 07054 www biomet com 0086 FLEX RANGE Front View Back View Not to scale ...

Page 40: ...NETRATION MAXIMUM FRACTURE LENGTH 8 cm 10 cm 7 cm 10 cm 102867 02 Rev 10 09 CABLE 11 cm 8 cm FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 2 R FLX 2 2 R FLX 2 4 R FLX 2 5 R C E N T I M E T E R S 0 1 2 3 4 5 6 7 8 9 10 11 12 FLEX RANGE Parsippany NJ 07054 www biomet com 0086 Parsippany NJ 07054 www biomet com 0086 Front View Back View Not to scale ...

Page 41: ...ch them Position coil on clavicle over fracture site according to physician instructions Position coil with cable toward waist Make sure coil is firmly in place before securing straps Bring long strap diagonally across the back and then around to the front across the chest Press strap onto Velcro hook Dotted line represents alternate placement of long strap Cut excess straps to size Short strap is...

Page 42: ...nector 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 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 If the coil edge does not fal...

Page 43: ...40 Back View Front View Not to scale ...

Page 44: ...ON GAUGE FLEXIBLE TREATMENT COIL FLX 2 3 R Front View COIL TOLERANCES FLEX SPAN MIN 120 MAX 150 MAXIMUM DEPTH OF PENETRATION MAXIMUM FRACTURE LENGTH 4 cm 8 cm 4 cm 8 cm 102867 23 Rev 10 09 FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 2 3 R 0086 Parsippany NJ 07054 www biomet com Back View Not to scale ...

Page 45: ... 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 f...

Page 46: ...ro hook before cutting excess straps to size DO NOT over tighten 4 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 on...

Page 47: ...t 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 replac...

Page 48: ...45 Front View Back View Not to scale ...

Page 49: ...roximal humerus fracture site according to physician instructions Position coil with cable toward waist Make sure coil is firmly in place before securing straps Bring the long strap diagonally across the back and then around to the front across the chest Press strap onto Velcro hook Readjust both straps for a secure comfortable fit DO NOT over tighten before cutting excess straps to size Second st...

Page 50: ...move 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 B...

Page 51: ... PENETRATION MAXIMUM FRACTURE LENGTH 7 cm 7 cm 5 5 cm 6 cm 102867 03 Rev 10 09 FLEXION GAUGE FLEXIBLE TREATMENT COIL FLX 3 R FLX 3 5 R CABLE 5 cm 9 cm 0 1 2 3 4 5 6 7 8 9 10 C E N T I M E T E R S FLEX RANGE Parsippany NJ 07054 www biomet com 0086 Parsippany NJ 07054 www biomet com 0086 Front View Back View Not to scale ...

Page 52: ...49 Front View Back View Not to scale ...

Page 53: ...ter the coil over the fracture site Conform the coil and verify with gauge Wrap lower strap around bottom of foot and attach to Velcro hook Adjust straps for comfort Excess strap length may be cut away When treatment is complete for the day remove the coilette by loosening the straps Wrap upper strap around ankle and cable Attach to Velcro hook 1 2 3 ANKLE APPLICATION 2 4 ...

Page 54: ... shape and remove Verify coil is conformed within treatment limit with Flexion gauge Secure upper proximal strap first Wrap strap around hand and attach to Velcro hook Adjust straps for comfort When treatment is complete for the day remove the coilette by loosening the straps Secure lower distal strap by wrapping around fracture site and attaching to Velcro hook Cut away excess strap length 1 2 3 ...

Page 55: ...ngth Flat Elliptical Saddle 3 5 cm 4 25 cm 5 5 cm 6 cm 6 cm 4 cm COIL SPECIFICATIONS 106109 Rev 10 09 TREATMENT XL COILETTE GAUGE FLX FLEXIBLE R 0086 Parsippany NJ 07054 www biomet com 52 CURVE CURVE S A D D L E E L L I P T I C A L 0086 Parsippany NJ 07054 www biomet com Front View Back View Not to scale ...

Page 56: ...Velcro is longer than the one without Velcro b Note The snap should be located in the center of your back a Wrap the long strap with Velcro around your chest and back onto itself Secure it in place with the Velcro Excess cable strap 1 2 CLAVICLE PLACEMENT APPLICATION INSTRUCTIONS See Conforming the Coil and Flexion gauge instructions on page 55 Components The FLX Coilette Clavicle comes with a FLX...

Page 57: ...ssing the strap over the Velcro on the Coilette and onto the chest strap Close the chest strap 4 5 a Adjust for comfort Excess shoulder and chest strap lengths may be then cut away b Common position 6a 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 rea...

Page 58: ... Remove the shaped coil and utilize the Flexion Gauge to verify the acceptable bend according to the shape listed below 3 If the 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 n...

Page 59: ...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 If the treatment coil edge does not fall within the green zone contact your Biomet representative for a suitable replacement and assistance R...

Page 60: ...ing strap to Velcro hook b Trim excess strap with scissors 3 4 Adjust FLX Mini Coilette to size by squeezing or opening Secure FLX Mini Coilette in place by wrapping strap around finger and securing onto Velcro hook 5 6 Trim excess strap with scissors Warning Do not place FLX Mini Coilette over metallic splints or jewelry Connect EBI Bone Healing System Stimulator link cable to wrist connector by ...

Page 61: ...58 Front View Back View Not to scale ...

Page 62: ...table bend according to the shape listed below 3 If the treatment 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 coil bend should not exceed the curve indicated on this Flexion Gauge Saddle Place the trea...

Page 63: ...tom of foot and attach to Velcro hook Wrap top strap around ankle and cable and attach to Velcro hook Adjust strap for comfort Excess strap length may then be cut away 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 Dual Velcro Straps with snap Cable FLX Coilette 1 2...

Page 64: ...tte over treatment site and bring straps around each side of thumb Secure Velcro straps onto the Velcro hook Adjust for comfort Excess strap length may then be cut away 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 Dual Velcro Straps with Velcro hooks ...

Page 65: ...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...

Page 66: ...L SPECIFICATIONS CURVE CURVE CURVE CURVE 102266 C00 Rev 10 09 S A D D L E E L L I P T I C A L E L L I P T I C A L FLEXIBLE TREATMENT COIL FLEXION GAUGE FLEXIBLE TREATMENT COIL COILETTE S A D D L E 0086 Parsippany NJ 07054 www biomet com 0086 Parsippany NJ 07054 www biomet com FLEXION GAUGE COILETTE Front View Back View Not to scale ...

Page 67: ...ontrol 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 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 thei...

Page 68: ...rous oxide Mode of operation continuous SYMBOL DESCRIPTION Type B Manufacturer Direct Current Catalog Number Alternating Current Serial Number Attention See Instructions Non ionizing Radiation Class II Single Patient Use Prescription Only Not for use by patients who are pregnant or becoming pregnant Not recommended for patients with certain types of pacemakers or implantable defibrillators Transpo...

Page 69: ...ic Field Treatment in Ununited Fractures and Failed Arthodeses Journal of the American Medical 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 ORDERING INFORMATION To order replacement coils or related components simply contact your B...

Page 70: ... 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 1067223 00 Charging Cradle 1067223 01 ...

Page 71: ...ectromagnetic 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 Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 2 The Model 2001 Bone Healing System must emit electromagnetic ...

Page 72: ... differential mode 2 kV for common mode Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Model 2001 Bone Healing System requires continued operation during power mains interruptions it is recommended that the Model 2001 Bone Healing System be powered from an unint...

Page 73: ... P is the maximum power output rating of the transmitter in watts W according to the 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 followi...

Page 74: ...istance 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 Table 4 71 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...

Page 75: ...cture 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 fra...

Page 76: ...nded to be used with certain types of demand pacemakers or implantable defibrillators or in close proximity to a person with a pacemaker or defibrillator 10 Question If I 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 t...

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