EXOGEN® User Guide
Contents
1. C or above 45 C e Damp or wet location and or near water e Outside use indoors only e Within the reach of small children e With the battery charger cable stretched across a floor or other areas where people walk that would cause a tripping hazard e On floor or other area where EXOGEN or the cable may be damaged by people walking on them EXOGEN Disposal EXOGEN is designed for single patient use only For details on how to dispose of EXOGEN correctly contact your local government waste disposal agency or Customer Service Caution Dispose of the battery properly to prevent environmental contamination and possible human injury Warning Do not throw any part of EXOGEN into fire Removing the Battery for Disposal Only remove the battery from EXOGEN for disposal To remove the battery follow these steps 1 Make sure EXOGEN is not plugged in to an electrical outlet 4 Remove the battery door by lifting up at the tab 2 Turn EXOGEN screen side down and find the battery door screw Gently lift battery out of compartment Push small tab inward to unlock connector 5 Gently lift the battery out of the compartment 6 Follow the red and black wires to find the battery connector 7 Push the small tab in and pull up to unlock the battery connector Customer Service Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 3 Use a screwdriver to remove the battery door screw 8 R2. perform the following steps Pause Treatment History You can pause the treatment history to view it for longer than 5 seconds To pause the treatment history perform the following steps 1 When you see the treatment history screen press the button to pause 2 The treatment history will pause and a pause symbol flashes 3 Press the button again to un pause the treatment history and continue 4 The treatment history screen will automatically un pause after 2 minutes and continue EXOGEN must be OFF and unplugged from the charger Press and hold the power button until the Treatment History Start screen appears The recent treatment history appears for 5 seconds This continues until your entire treatment history has been shown After the last treatment history screen displays for 5 seconds EXOGEN beeps and turns itself off You may exit the Treatment History mode at any time by pressing and holding the button until EXOGEN turns itself off exogen Treatment History Start Screen pi 43 84 AAAA AMANA NV ASA NV SA AR OR AR AR AR AR AE AAAA VS SG VV VVVY 116 0 exogen B 0 o 116 250 100 o Treatment History Screen 2 exogen il 116 250 100 Treatment History Screen 1 VV VV SAAANA NA VAR AR AR AR AL AR A PSY SSSS SAACAN ANA VV AY 2 116 X 0 exogen S 0 o 116 250 100 Treatment His
3. 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Test Report 100972305ATL 002 02 07 2013 Testing performed by Intertek 1950 Evergreen Blvd Suite 100 Duluth GA 30096 Customer Service Customer Service is available to answer questions regarding EXOGEN and to handle servicing or disposal needs To contact the International Service Center Call toll free Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 00800 02 04 06 08 customercare international bioventusglobal com pr Authorized European Community EC Representative EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 0 70 345 8570 Fax 31 0 70 346 7299 Australian Sponsor Emergo Australia Level 20 Tower Il Darling Park 201 Sussex Street Sydney NSW 2000 Australia For additional information on the EXOGEN Ultrasound Bone Healing System please visit our website at www exogen com Limited Warranty Bioventus LLC Seller warrants to the original purchaser Purchaser of its EXOGEN Ultrasound Bone Healing System System purchased by Purchaser directly from Seller that the System conforms to Seller s manufacturing specifications This warranty shall be in effect for a period of one year fr
4. 2 Pull the long end of the strap through the plastic loop as shown 5 Tighten the strap by pulling on the long end Fasten the strap in place Do not make the strap too tight 4 Close the Cover 5 Leave your Card in EXOGEN until all your treatments have been used If you have used all the treatments on your card and you feel your fracture has still not healed contact your doctor 3 Use 2 fingers to squeeze the cap tabs together to open the cap 2 Use 2 fingers to squeeze the cap tabs together to open the cap 3 Pull out the round felt plug inside the opening Customer Service Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 Add Gel and Place Transducer Note Some patients have experienced mild skin irritation caused by skin sensitivity to the gel If you feel your skin is sensitive to the gel you may change the gel to mineral oil or glycerin Add gel on the transducer every time you treat your fracture 1 Take the cap off the gel bottle 2 Hold the transducer so the cord is down and the smooth side of the transducer is up Press down on the gel bottle nozzle 4 Put the transducer gel side down into 5 Align the cord coming out of the to put gel on the smooth side of the the port The gel will be touching the transducer with the notch in the transducer You only need one full skin over your treatment site cap Snap the cap shut on the pump of gel on the transducer strap or
5. Recharging EXOGEN Check the charge level on EXOGEN following treatment If the battery is low charge EXOGEN with the supplied charger See the Charging EXOGEN page 4 for instruction on charging EXOGEN Treatment Card Insertion Cover closed 1 Find the cover on the right side of EXOGEN Preparing to Treat Your Fracture To treat your fracture you will need EXOGEN the gel and strap If you have a cast around your fracture you will not need the strap Your doctor may have marked your fracture site with an X or told you where to treat your fracture This is the spot to place the transducer to treat your fracture Contact your doctor if you are not sure where to treat your fracture Before you begin check the cable and the transducer for any cracks or signs of damage If damaged do not use EXOGEN and contact Customer Service Precaution The transducer strap and gel are not sterile and placement on an open wound is not advised 2 Pull down the tab to open the cover Place the Strap 1 Position the strap with the cap facing up 4 Slide on the strap and place the port over the X mark on your skin If You Have a Cast 1 Your cast will have a plastic port with cap built into it Treatment Card metal contacts facing up 3 Put the Card into the port metal contacts facing up and entering first Press the card into EXOGEN until the card clicks into place
6. effects as demonstrated in live pigs with surgical metallic implants Arch Phys Med Rehabil 1979 483 488 Lotsova El Effect of ultrasound on the strength of metal fixing pins for fractures and joint injuries Mekh Kompoz Mat 1979 No 3 548 549 Premarket Approval P900009 Supplement 6 Summary of safety and effectiveness data low intensity pulsed ultrasound device for the noninvasive treatment of nonunions Skoubo Kristensen E Sommer J Ultrasound influence on internal fixation with a rigid plate in dogs Arch Phys Med Rehabil 1982 63 371 373 Pounder NM Harrison AJ Low intensity pulsed ultrasound for fracture healing A review of the clinical evidence and the associated biological mechanism of action Ultrasonics 2008 48 330 338 Siska PA Gruen GS Pape HC External adjuncts to enhance fracture heating What is the role of ultrasound Injury International Journal of the Care of the Injured 2008 39 1095 1105 Rubin C Bolander M Ryaby JP Hadjiargyrou M The use of low intensity ultrasound to accelerate the healing of fractures J Bone Joint Surg 2001 83 A No 2 259 270 Ziskin MC Report on the safety of the Therasonics Medical Systems SAFHS unit model 2A PMA900009 vol 3 section VI A 1 209 234 Technical Information EXOGEN Operating Specifications Ultrasound frequency Modulating signal burst width Repetition Rate Duty Factor Effective radiating area ERA Temporal average power Spatial avg t
7. intensity ultrasound Clin Orthop Relat Res 1998 355S S216 229 Handolin L Kiljunen V Arnala Pajarinen J Partio EK Rokkanen P The effect of low intensity ultrasound and bioabsorbable self reinforced poly L lactide screw fixation on bone in lateral malleolar fractures Arch Orthop Trauma Surg 125 5 317 21 Heckman JD Ryaby JP McCabe J Frey JJ Kilcoyne RF Acceleration of tibial fracture healing by non invasive low intensity pulsed ultrasound J Bone Joint Surg 1994 76 A 1 26 34 Jones CP Coughlin MJ Shurnas PS Prospective CT scan evaluation of hindfoot nonunions treated with revision surgery and low intensity ultrasound stimulation Foot amp Ankle International 2006 27 229 235 Katsuki M Mikami J Matsuno T Clinical results of sonic accelerated fracture healing system for upper extremity diseases Journal of Japanese Society for Surgery of the Hand 2002 19 5 601 605 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Kristiansen TK Ryaby JP McCabe J Frey JJ Roe LR Accelerated healing of distal radial fractures with the use of specific low intensity ultrasound J Bone Joint Surg 1997 79 A 7 961 973 Lerner A Stein H Soudry M Compound high energy limb fractures with delayed union our experience with adjuvant ultrasound stimulation Exogen Ultrasonics 2004 42 1 9 915 917 Leung KS Lee WS Tsui HF Liu PP Cheung WH Complex tibial fractur
8. the cast Note The first time you use the gel you may need to pump a few times to start the gel flowing 6 Replace the cap on the gel bottle O LUI A TE gt lt LL EXOGEN Setup First Use EXOGEN tracks how often the system is used The current hour needs to be set to make sure the tracking is accurate The hour must be set once the very first time EXOGEN is turned on Hour Setting 1 Press the button once The hour and AM PM show on the screen This may or may not be your current hour The clock must be set to your current hour For example if your time is anywhere between 2 00 PM and 2 59 PM set the hour to 2 PM 2 Press the button once to advance the time one hour Press the button one press at a time until the correct hour and AM PM is displayed on the screen 3 Press and hold button until you see the hour confirmation screen This indicates that the hour has been set on EXOGEN You do not need to set the minutes After 5 seconds the device will beep and automatically turn off Contact Customer Service if you have incorrectly set the time r bioventus www exogen com Press button Start up screen Time set Press button once to advance hour Press button once to advance hour Flashing time set screen Press amp hold Current hour Confirmation Screen Treating Your Fracture Start Treatment Hold EXOGEN in your
9. to the use of EXOGEN Warnings The safety and effectiveness of the use of EXOGEN has not been established for e Fractures with post reduction displacement of more than 50 i e fractures in which the opposing broken bone ends are out of alignment by more than one half of the width of the bone Pathological fractures due to bone pathology or malignancy fractures due to disease Pregnant or nursing women Individuals with thrombophlebitis blood clot in a vein vascular insufficiency poor blood supply abnormal skin sensitivity very sensitive skin sensory paralysis lack of sensation alcoholism and or nutritional deficiency Individuals receiving steroid anti coagulant prescription non steroidal anti inflammatory calcium channel blocker and or diphosphonate therapy Individuals using these therapies were excluded from the studies because of the possible effects of these therapies on bone metabolism e Non unions of the vertebra and the skull e Individuals lacking skeletal maturity Precautions e EXOGEN will not correct or alter post reduction when your fracture is initially set and placed in a cast aspects of a fracture such as displace ment angulation or malalignment The transducer strap and gel are not sterile and placement on an open wound is not advised The operation of active implantable devices such as cardiac pacemakers may be adversely affected by close exposure to EXOGEN The p
10. EXOGEN User Guide Read before using your device Q bioventus EXOGEN Overview Getting Started EXOGEN Setup Tracking Your Treatment Troubleshooting EXOGEN Care Customer Service EXOGEN Label Symbol Descriptions and Equipment Classification Table of Contents Information Symbol refer to User Guide EXOGEN Overview 1 Troubleshooting 15 Indications for Use 1 Catalog Numb Soe EXOGEN Device 1 Operating Conditions 16 CE Mark indicates conformity with European Council Directive of 14 June 1993 concerning Medical Devices 93 42 EEC Charger power supply 2 Storage 16 Strap 2 EXOGEN Expected Service Life 16 Type BF Applied Part The transducer shown in Figure 2 on page 1 is an applied part rasouna Gouping agl A Sa cs Con A i i ucer shown in Figu i i an ji j ji es Treatment Card 2 EXOGEN Disposal 17 EXOGEN Usage 2 Removing the Battery for Disposal 17 EU Not for General Waste Important Things to Know 3 noi i This symbol indicates that EXOGEN should not be disposed of with ordinary household waste at the end of its life For details on how Contraindications 3 Clinical Studies 18 to dispose of this device correctly contact your local government waste disposal agency or your local Bioventus representative Warnings 3 Metals and Implants 18 Precautions 3 prea pu pait This symbol indicates the authorized representative in the European Community ONE RER ji Complications 18 Treatment Card Insertion 5 Referenc
11. N should be used for 20 minutes per day or as prescribed by your doctor It is important that you use EXOGEN as prescribed by your doctor to get the full benefit of the treatment Your doctor will decide when your fracture is healed Every fracture is different and it takes some fractures longer to heal than others Call your doctor if you have questions or concerns about your fracture EXOGEN is for single patient use only EXOGEN will deliver the number of treatments provided on your treatment card If this number is reached and you are still treating your fracture under your doctor s direction contact Customer Service for instructions Important Things to Know EXOGEN is approved for use by persons that are 18 years or older and skeletally mature There is no maximum age limit to using EXOGEN The anticipated education level of an EXOGEN user is to read English to an 8th Grade level or equivalent and the ability to read and understand Western Arabic numerals No special previous experience or skills are needed or expected to be able to operate EXOGEN There may be physical impairments that result from the presence of a fracture such as reduced range of motion or immobility EXOGEN is expected to be useable with one hand used for guiding and holding EXOGEN Read Getting Started page 4 and Treating Your Fracture page 9 before you begin using EXOGEN Contraindications There are no known contraindications
12. ani F Mariani PP Low intensity pulsed ultrasound in the conservative treatment of pseudoarthrosis Journal of Sports Medicine and Physical Fitness 2004 44 173 178 Pilla AA Figueiredo M Nasser PR Alves JM Ryaby JT Klein M Kaufmann JJ Siffert RS Acceleration of bone repair by pulsed sine wave ultrasound animal Clinical and mechanistic studies In Electromagnetics in Biology and Medicine ed by CT Brighton and SR Pollock San Francisco Press 331 341 1991 Romano C Messina J Meani E Low intensity ultrasound for the treatment of infected nonunions In Agazzi M Bergami PL Cicero G Gualdrini G Mastorillo G Meani M Mintina S Soranzo ML editors Guarderni di infezione osteoarticolari 1999 83 93 Sato W Matsushita T Nakamura K Acceleration of increase in bone mineral content by low intensity ultrasound energy in leg lengthening J Ultrasound Med 1999 18 699 702 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 Strauss E Gonya G Adjunct low intensity 48 ultrasound in charcot neuroarthropathy Clin Orthop Relat Res 1998 349 132 138 Strauss E Ryaby JP McCabe JM Treatment of Jones fractures of the foot with adjunctive 49 use of low intensity pulsed ultrasound stimulation J Orthop Trauma 1999 13 4 310 Tsumaki N Kakiuchi M Sasaki J Ochi T Yoshikawa H Low intensity pulsed ultrasound accelerates maturation of callus in patient
13. atments 223 238 241 251 261 271 28 on this day 29h 301 S310 322 33 234 35 You completed three or more 20 minute If You Have a Cast 564 34 384 394 404 41i 42 POUR TRES rente onithis day Follow steps 1 3 above and then do the a 4 exogen PS following instead of step 4 p O j 9 250 64 Y 0 data Partial treatment You treated for less than 20 minutes 6 Snap the cap shut 5 Insert the felt plug with the tab up into the port This plug helps prevent swelling in the cast when you are not using EXOGEN 4 Carefully clean any gel from your cast skin and port with a soft cloth 7 Place EXOGEN and the gel back into the carrying case until you are ready to treat again PVR VV r Figure 8 Treatment History Screen X S on this day EXOGEN should be used for 20 minutes per day or as prescribed by your doctor Customer Service Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 11 Summary Data SP Treatment Days Treatment days are the number of days that you have completed a 20 minute treatment Cumulative Partial Treatments Cumulative Partial Treatments are the number of partial treatment minutes that add together to count against your treatment card When the sum of your partial treatment reaches 20 minutes it will count as one full treatment against your card Treatment Card Treatment Car
14. cation in which EXOGEN is used exceeds the applicable RF compliance level above EXOGEN should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating EXOGEN Over the frequency range 150 kHz to 80 MHz field strengths should be less than 1 V m Customer Service Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 21 Recommended separation distances between portable and mobile RF communications equipment and EXOGEN EXOGEN is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of EXOGEN can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and EXOGEN as recommended below according to the maximum output power of the communications equipment Rated maximum output power of Separation distance according to frequency of transmitter meter m transmitter watts W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2 P d 2 3 P For transmitters rated at a maximum output power 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
15. creased radiofrequency emissions or decreased electromagnetic immunity of the EXOGEN which may cause EXOGEN to stop working The USB plug end of the cord plugs into EXOGEN The other end plugs into a wall outlet The charger requires a standard 100 240 VAC 50 60 Hz household electrical outlet One of the following chargers will be included with EXOGEN depending on the electrical requirements of your country Australia Part 71034463 Europe Part 71034462 United Kingdom Part 71034461 Read more about how to charge EXOGEN in Getting Started on page 4 Mini USB plug Figure 3 EXOGEN Charger Strap The strap Figure 4 is used to position the transducer over your treatment site The strap has a port in it to hold the transducer in place The cap holds the transducer down on the treatment site The strap is adjustable to fit most fracture locations If your strap does not fit the location of your fracture please contact Customer Service to find out if there is another strap which may fit better Figure 4 EXOGEN Strap Part Number 71034622 Ultrasound Coupling Gel Ultrasound coupling gel Figure 5 is provided for use with EXOGEN The gel is to be placed on the transducer every time you use EXOGEN The gel lets the ultrasound signal reach your fracture through your skin EXOGEN will not work properly if gel is not covering the transducer and you will receive an alert from EXOGEN Only
16. d be used no closer to any part of EXOGEN including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz d_1 2 VP d_ 1 2 VP 80 MHz to 800 MHz d_ 2 3 VP 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended 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 equipment marked with the following symbol el NOTE U is the a c mains voltage prior to application of the test level NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 predicted 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 lo
17. d is the ratio of the number of 20 minute treatments used versus the number of treatments assigned to the Treatment Card inserted into your EXOGEN device The total number of treatments used is the sum of the Treatments ef and Cumulative Partial Treatments E Missed Treatment Days are the number of days that you did not complete a 20 minute treatment This is the total of all days marked with an X Missed Treatment Days 100 Compliance Percentage Compliance Percentage is the number of days a full treatment was delivered divided by the number of total days since you began using EXOGEN If you have EXOGEN for 60 days but forgot to treat 8 of those days and 2 days you only treated for 10 minutes you will have the following numbers Fifty 20 minut treatments delivered 1 cumulative partial treatment sum of two 10 minute partial treatments exogen 83 51 treatments o used on the card 250 treatments assigned to card 8 missed treatment days compliance 50 60 Treatment History After using EXOGEN over time you may want to view your treatment history and show it to your doctor EXOGEN lets you view your treatment history without having to start a treatment You can start EXOGEN in Treatment History mode You cannot enter Treatment History mode when EXOGEN is being charged To view your treatment history
18. e life of EXOGEN and its accessories is 343 treatments 6860 minutes Once EXOGEN delivers 343 treatments it will not provide further treatment Battery and Charging Satety Battery e Do not attempt to replace the lithium ion battery e Do not attempt to replace the lithium ion battery with non approved batteries Incorrect replacement of the battery could result in damage to EXOGEN The battery should only be serviced by Bioventus trained personnel Be sure to use only the USB battery charger provided with the system see page 2 Other battery chargers may cause battery overheating and damage the battery EXOGEN the battery chargers or the user Do not use an extension cord with the battery charger as this may cause overheating Do not use the battery charger with other devices as this may damage the battery charger and or the other device If the battery area on EXOGEN or the battery charger becomes excessively warm discontinue using and contact Customer Service Charging e Charge the battery to at least 25 capacity one bar before attempting to perform a treatment when the battery is used for the first time or after prolonged storage e The battery will charge whether EXOGEN is turned off or on e If the battery power decreases quickly even after recharging for many hours contact Customer Service Do not recharge the battery in any of the following locations e Where the ambient temperature is below 0
19. e outcomes following treatment with low intensity pulsed ultrasound Ultrasound Med Biol 2004 30 389 395 Mayr E Frankel V Ruter A Ultrasound an alternative healing method for nonunions Arch Orthop Trauma Surg 2000 120 1 8 Mayr E Laule A Suger G Ruter A Claes L Radiographic results of callus distraction aided by pulsed low intensity ultrasound J Orthop Trauma 2001 15 6 407 414 Mayr E Mockl C Lenich A Ecker M R ter A Is low intensity ultrasound effective in treating disorders of fracture healing Unfallchirurg 2002 105 108 115 Mayr E Rudzki MM Borchardt B Ha sser H Ruter A Does pulsed low intensity ultrasound accelerate healing of scaphoid fractures Handchir Mikrochir Plast Chir 2000 32 115 122 Mayr E Wagner S Ecker M Ruter A Ultrasound therapy for nonunions pseudarthrosis three case reports Unfallchirug 1999 102 3 191 196 Narasaki K Low intensity ultrasound treatment of nonunion and delayed union cases Orthopaedic Surgery and Traumatology Japanese language 2000 43 3 225 230 Nolte PA Klein Nuland J Albers GHR Marti RK Semeins CM Goei SW Burger EH Low intensity ultrasound stimulates in vitro endochondral ossification J Orthop Res 2001 16 2 16 22 Nolte PA van der Krans A Patka P Janssen IMC Ryaby JP Albers GHR Low intensity pulsed ultrasound in the treatment of nonunions J Trauma 2001 51 4 693 703 Pigozzi F Moneta MR Giombini A Giannini S Di Cesare A Fagn
20. emove and properly dispose of the battery according to your local or national refuse laws 18 Clinical Sfudies The EXOGEN Ultrasound Bone Healing System has been evaluated for osseous defect healing in a number of clinical 1 39 studies These studies have demon strated acceleration of fresh fracture by 38 and a non union heal rate of 86 Metals and Implants Clinical data indicates that healing rates and acceleration of osseous defect repair is not affected by internal or external metal fixation Several reference articles have focused on conventional therapeutic ultrasound s effect on surgical metallic biodegradeable and bioresorbable implants and conclude there are no untoward effects EXOGEN low intensity pulsed ultrasound is not capable of penetrating metal when treating osseous defects with plate fixation place the transducer over the fracture site but not directly over the plate Mechanism of Action Four review articles have assessed the clinical and basic science evidence for the EXOGEN Ultrasound Bone Healing System Their analyses suggested the EXOGEN Ultrasound Bone Healing System induced cellular reactions at each phase of fracture healing from inflammation through to endochondral ossification and remodelling Adverse Events Unlike conventional physical therapy ultrasound devices EXOGEN is incapable of producing harmful temperature increases in body tissue The ultrasound
21. emporal avg SATA Beam non uniformity ratio BNR Battery Battery Type Input Voltage USB Beam type 1 5 5 MHz 200 10 microsecond us 1 0 10 kilohertz kHz 20 3 88 1 square cm cm 117 30 milliwatts mW 30 30 mW cm 4 0 maximum 3 7 VDC 700 mAh Lithium ion 5 0 VDC 2 6A max Collimated The essential performance of EXOGEN includes the following e Free from the display of incorrect numerical values numbers associated with the ultrasound therapy e Free from the production of unwanted ultrasound output e Free from the production of excessive ultrasound output e Free from the production of unintended or excessive transducer surface temperature Customer Service Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 19 20 EXOGEN Classifications EXOGEN has the following classifications e Internally Powered Equipment e Type BF Applied Part e EXOGEN device IP 22 protection against ingress of water e Transducer IP 67 protection against ingress of dust e Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or with nitrous oxide e Mode of operation Intermittent Guidance and Manufacturer s Declaration Electromagnetic Emissions and Immunity Testing Electromagnetic Compatibility Testing Summary Testing Report for Bioventus LLC Equipment Under Test EXOGEN Used for Life Supp
22. es 18 Rx Symbol Federal Law U S A restricts this device to sale distribution or use by or on the order Place the Strap 5 Technical Information 19 Kon of a physician or properly licensed practitioner This device is only intended for use by the individual If You Have a Cast 5 a i for whom it is prescribed Add Gel and Place Transducer 6 EXOGEN Classifications 20 Guidance and EXOGEN Setup 8 Manufacturer s Declaration 20 THIS DEVICE IS NON STERILE Fi It does not require sterilization before use irst Use 8 F Hour Setting 8 Customer Service 23 Treating Your Fracture 9 Limited Warranty 23 EXOGEN Cleaning 10 Tracking Your Treatment 11 EXOGEN Overview Indications for Use EXOGEN Ultrasound Bone Healing System is indicated for the non invasive treatment of osseous defects excluding vertebra and skull that includes e Treatment of delayed unions and non unions e Accelerating the time to heal of fresh fractures e Treatment of stress fractures e Accelerating repair following osteotomy e Accelerating repair in bone transport procedures e Accelerating repair in distraction osteogenesis procedures e Treatment of joint fusion A non union is considered to be established when the fracture site shows no visibly progressive signs of healing Treatment card gt EXOGEN Description The EXOGEN Ultrasound Bone Healing System provides non invasive therapy for healing non unions and accelerating time to healing of fre
23. gged in and charging Shows how much charge is left in the battery A treatment was not completed on this day A 20 minute treatment was completed on this day Two 20 minute treatments were completed on this day Three or more 20 minute treatments were completed on this day A treatment was delivered on this day but was less than 20 minutes Flashes during use to show you are treating your fracture Counts down from 20 minutes to show treatment time remaining Automatically displays when countdown timer reaches zero to show that treatment is complete EXOGEN should be used for only 20 minutes per day or as prescribed by your doctor Customer Service Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 Getting Started Charging EXOGEN EXOGEN has a rechargeable lithium ion battery A fully charged battery delivers approximately five 20 minute treatments It takes about 5 hours to fully charge a discharged EXOGEN battery WARNING To avoid the risk of electric shock EXOGEN must only be connected to a supply mains with protective earth a 3 prong electrical outlet Do not use any adapters or extension cords to charge EXOGEN Only plug the charger into an UL listed electrical outlet Charge EXOGEN before you begin a treatment or turn EXOGEN on Follow the steps on the right to charge EXOGEN As you use EXOGEN the symbol will change to show the reduced battery life See Fig
24. hand to view the screen or set EXOGEN down on a nearby flat surface Perform the following steps to begin treatment 1 Press the button on EXOGEN EXOGEN beeps and the start up screen appears for 2 seconds 2 Atreatment history screen appears on the screen for 5 seconds It shows your treatment summary For more information on the screen see Tracking Your Treatment on page 11 3 Next the 20 minute countdown timer appears on the screen EXOGEN automatically begins the ultrasound treatment A treatment symbol flashes as the timer counts down This means you are treating your fracture Note To stop EXOGEN in the middle of the 20 minute treatment press and hold the button until EXOGEN turns off If your EXOGEN has an error during treatment see Troubleshooting on page 15 4 When the countdown timer reaches zero EXOGEN beeps and shows the treatment complete checkmark The treatment complete checkmark displays for 5 seconds Then EXOGEN beeps and turns itself off Note Do not remove the Treatment Card while treating your fracture exogen bioventus www exogen com Press button Pa Start up screen 0 0 E 0 0 60 Treatment History Screen exogen 0 Completion Customer Service Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 m gt L m Z m U 9 Tracking Your EXOGEN Cleaning T
25. harging port and Treatment Card port The cord and transducer are not removable from EXOGEN EXOGEN contains the internal electronics and battery It checks the ultrasound signal to make sure EXOGEN works properly The transducer sends low intensity pulsed ultrasound to the fracture site through the gel EXOGEN can also sense if gel is present on the transducer surface EXOGEN stores and displays your daily use This data is available to you and your physician EXOGEN has a mini USB charging port to allow you to recharge the battery EXOGEN will not communicate with any other electrical devices Card Port not shown Color Screen MEARE NORNERSIOyE sxogen EXOGEN Device Sound Coupling 6 te ith EXOGEN ultrasound System Button Coiled Cord Transducer Figure 1 EXOGEN Ultrasound Bone Healing System Figure 2 EXOGEN Device Part 71034451 Customer Service Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 1 Charger power supply EXOGEN is powered by a rechargeable battery charger Figure 3 is included with EXOGEN Your charger may look different from the image below depending on the country where you live Only use this supplied charger with EXOGEN Do not plug other chargers into EXOGEN Other chargers may cause injury to you or others near EXOGEN as well as damage to the charger The use of chargers transducers or cables other than those supplied may result in in
26. hysician should advise the patient or other person in close proximity during treatment to be evaluated by the attending cardiologist or physician before starting treatment with EXOGEN The cords pose a risk for strangulation Keep out of reach of children Cell phones televisions and other devices using radiofrequency energy may cause interference This interference may cause EXOGEN to operate improperly or stop operating completely While EXOGEN complies with the limits for Class B digital devices pursuant to Part 15 of the FCC rules it has not been studied with all brands and models of phone The safety and effectiveness of EXOGEN when used for more than one daily 20 minute treatment period has not been studied For single patient use ONLY The risk includes but is not limited to cross contamination between patients as cleaning agents and solvents are not recommended for this system When choosing a treatment site ensure that the site selected allows for full contact of the transducer face with the skin Failure to do so may result in the transducer being only partially coupled to the skin This may reduce the effectiveness of EXOGEN in treating the fracture Display Symbols and Descriptions Charging Symbol Battery Status IT EE Double Checkmark Double Checkmark Plus Treatment Symbol Countdown Timer Treatment Complete Partial Treatment PR Description Flashes to show EXOGEN is plu
27. in the vicinity of equipment such as portable and mobile communication units marked with this symbol si If abnormal operation of EXOGEN is observed attempt to relocate or reorient EXOGEN in relation to the interfering equipment until the interference stops The charger will function with an input voltage range from 100 VAC 240 VAC and has an operating frequency range is from 50 60 Hz The charger output is 5 VDC EXOGEN and accessories should be stored and transported within Ambient temperature range 0 C to 32 C 32 F to 89 F Relative humidity range 15 to 75 Atmospheric pressure range 700 hPA to 1060 hPA If EXOGEN is stored or transported in temperatures outside this range allow EXOGEN time to come to room tempera ture for at least 30 minutes before operating The least favorable working conditions for EXOGEN are 32 C at 75 Humidity Storage e To prevent damage to EXOGEN and its accessories store EXOGEN in its carrying case while not in use Do not store EXOGEN near radiators or extreme heat e Do not expose EXOGEN to extreme tem peratures or the internal electronic components may be damaged e As with any home electronic device protect EXOGEN from impact exposure to moisture liquid spills sand dirt or debris After your fracture has healed or prior to long term storage of EXOGEN remove the battery to prevent leakage of the battery EXOGEN Expected Service Life The expected servic
28. l the relative humidity should be at least 30 Electrical fast transient 2 kV for power supply 2 kV for power supply burst lines lines IEC 61000 4 4 1 kV for input output Not Applicable for input lines output lines 1 kV differential mode 2 kV common mode U lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec 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 Mains power quality should be that of a typical commercial or hospital environment If the user of EXOGEN requires continued operation during power mains interruptions it is recommended that EXOGEN be pow ered from an uninterruptible power supply or a battery Voltage dips short lt 5 interruptions and voltage gt 95 dip in U for 0 5 variations on power cycle 40 U 60 dip supply input lines IEC in U for 5 cycles 70 61000 4 11 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec T Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com mercial or hospital environment Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Portable and mobile RF communications equipment shoul
29. m Customer Service Australia 1800 428 220 Ireland 1800 552 197 UK 0800 0516384 00800 02 04 06 08 What should I do Add more gel to the transducer See Add Gel and Place Transducer on page 6 After you add more gel place the transducer back over the fracture using the strap or cast port EXOGEN will stop beeping and the countdown timer will restart If EXOGEN still beeps and the Add Gel screen remains add more gel Plug EXOGEN into a power source with the provided charger It is safe to charge EXOGEN and treat at the same time See Charging EXOGEN on page 4 Call Customer Service Do not try to fix EXOGEN yourself Insert your card if it is not already inserted If the card is inserted remove it and reinsert it according to the directions in the Treatment Card Insertion section on page 5 If you are still having trouble please contact Customer Service If you are still being instructed by your doctor to treat your fracture with EXOGEN call Customer Service for instructions If you are still being instructed by your doctor to treat your fracture with EXOGEN call Customer Service for instructions What should I do Plug in charger to EXOGEN and fully charge your battery If EXOGEN still does not respond contact Customer Service Stop using EXOGEN and contact Customer Service ONILOOHS4 1dNOdL 16 EXOGEN Care EXOGEN should be handled with care Please note the following e Use
30. om the date of purchase In the event of a material breach of this warranty upon timely written notice Seller will at its sole option either repair or replace the System or refund the original purchase price This will constitute Purchaser s sole remedy This limited warranty does not extend to any re sale or other transfer of the System by Purchaser to any other person or entity Seller expressly disclaims any and all other warranties either expressed or implied relating to the System or its performance including without limitation any IMPLIED WARRANTY OF MERCHANTABILITY and any IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE 23 JVDIASAS AAWOLSNO Authorized European Community EC Representative EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 0 70 345 8570 Fax 31 0 70 346 7299 Bioventus LLC 4721 Emperor Blvd Suite 100 Durham NC 27703 USA General Information 1 800 396 4325 International Customer Service toll free Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 00800 02 04 06 08 customercare international bioventusglobal com www exogen com 2014 Bioventus LLC All rights reserved EXOGEN and the Bioventus logo are registered trademarks of Bioventus LLC Product No 81087028 Rev A 2014 10 CE Q bioventus
31. only a clean soft cloth paper towel or cotton swab to clean EXOGEN the transducer and the strap Do not use cleaning agents or solvents on any of the components of the system Do not attempt to modify disassemble or repair the EXOGEN There are no user serviceable parts inside EXOGEN Exercise care when handling the transducer as rough handling may scratch the transducer face and cause EXOGEN not to work properly If any parts of EXOGEN or its accessories are damaged do not use EXOGEN Please contact Customer Service to return your EXOGEN for servicing EXOGEN is classified as an IP 22 device The IP 22 classification indicates that EXOGEN provides Protection against the access of fingers or similar objects from the internal components of EXOGEN Protection against the harmful ingress of water into the enclosure of EXOGEN when tilted up to 15 from normal position e The EXOGEN transducer is classified as an IP 67 component The IP 67 classification indicates that the transducer is Dust tight Will not be damaged by water under defined conditions of pressure and time up to 1 meter underwater e Never put EXOGEN in or under water Operating Conditions EXOGEN should be operated within Ambient temperature range 5 C to 32 C 41 F to 89 F Relative humidity range 15 to 75 non condensing Atmospheric pressure range 700 hPA to 1060 hPA Interference with proper operation of EXOGEN may occur
32. or examples of alerts and what to do if you get an alert Alerts What does this mean Gel Error The countdown timer stops EXOGEN beeps and displays the yellow Add Gel screen There is not enough gel on the transducer Low Battery You are not able to start treatment or view history EX OGEN beeps and displays the yellow Low Battery screen The battery level is very low You must charge EXOGEN Contact Customer Service EXOGEN beeps and displays the yellow Contact Customer Service screen EXOGEN has detected that it is not working properly Treatment Card Error Your Treatment Card is missing or is improperly inserted No Remaining Treatments on the Treatment Card EXOGEN beeps and displays the yellow No Remaining Treatments screen No treatments remain on the Treatment Card that is currently inserted in the device End of Service EXOGEN beeps and displays the yellow No Remain ing Treatments screen EXOGEN has reached the end of its expected service life 343 treatments Note Your Treatment Card may still have treatments remaining but the number of treatments used and the number of treatments available on the card will not be displayed Problems What does this mean The battery may be completely discharged or your EXOGEN has malfunctioned Blank screen EXOGEN does not turn on The battery area on The battery or charger is malfunctioning EXOGEN or the battery charger gets excessively war
33. ort No Use in shielded enclosure No Guidance and manufacturer s declaration electromagnetic emissions EXOGEN is intended for use in the electromagnetic environment specified below The customer or the user of EXOGEN should assure that it is used in such an environment Emissions Test Electromagnetic environment guidance RF emissions Group 1 EXOGEN uses RF energy only for its internal function Therefore its RF emissions CISPR 11 are very low and are not likely to cause any interference in nearby electronic equip ment RF emissions Class B EXOGEN is suitable for use in all establishments other than domestic and those CISPR 11 directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Surge 1 kV differential mode IEC 61000 4 5 2 kV common mode U Guidance and manufacturer s declaration electromagnetic immunity EXOGEN is intended for use in the electromagnetic environment specified below The customer or the user of the EXOGEN should assure that it is used in such an environment Immunity test IEC 60601 Test Level Compliance Level Electromagnetic environment guidance Electrostatic discharge 6 kV contact 6 kV contact ESD 8 kV air 8 kV air IEC 61000 4 2 Floors should be wood concrete or ceramic tile If floors are covered with synthetic materia
34. output intensity of EXOGEN is 30 mW cm and is typically only 1 to 5 of the output intensity of conventional therapeutic ultrasound devices The ultrasound intensity is comparable to diagnostic ultrasound 1 to 50 mW cm such as the intensities used in obstetrical sonogram procedures fetal monitoring In addition there is no evidence of non thermal adverse effects cavitation Complications No device related adverse reactions or medical complications related to the use of EXOGEN were reported during the clinical studies Some patients have experienced mild skin irritation caused by skin sensitivity to the coupling gel If you feel your skin is sensitive to the gel you may change the coupling medium to mineral oil or glycerin In the distal radius study one patient complained of pain during treatment but they no longer had the pain by the next follow up visit and one patient complaining of pain withdrew from the study References 10 11 12 13 15 16 Cook Ryaby JP McCabe J Frey JJ Heckman JD Kristiansen TK Acceleration of tibia and distal radius fracture healing in patients who smoke Clin Orthop Relat Res 1997 337 198 207 Coughlin MJ Simth BW Traughber P The evaluation of the healing rate of subtalar arthrodeses part 2 The effect of low intensity ultrasound stimulation Foot amp Ankle International 2008 29 970 977 Duarte LR University of Sao Paulo Brazil unpublished data
35. presented Societe Internationale de Chirurgie Orthopedique et de Traumatologie SICOT El Mowafi H Mohsen M The effect of low intensity pulsed ultrasound on callus maturation in tibial distraction osteogenesis Int Orthop 2005 29 121 124 Frankel VH Mizuno K Management of nonunion with pulsed low intensity ultrasound therapy international results Surg Technol Int 2001 X 1 6 Frankel VH Results of prescription use of pulsed ultrasound therapy in fracture management Surg Technol Int 1998 VII 389 393 Fujioka H Tanaka J Yoshiya S Tsunoda M Fujita K Matsui N Makino T Kurosaka M Ultrasound treatment of nonunion of the hook of the hamate in sports activities Knee Surg Sports Traumatol Arthrosc 2004 12 2 162 164 Fujioka H Tsunoda M Noda M Matsui N Mizuno K Treatment of ununited fracture of the hook of hamate by low intensity pulsed ultrasound a case report J Hand Surg 2000 25 1 77 79 Furue Y The effect of low intensity pulsed ultrasound for treatment of nonunion Orthopaedic Surgery and Traumatology Japanese language 2000 43 3 231 235 Gebauer D Mayr E Orthner E Ryaby JP Low intensity pulsed ultrasound effects on nonunions Ultrasound Med Biol 2005 31 1391 1402 Gold SM Wasserman R Preliminary results of tibial bone transports with pulsed low intensity ultrasound Exogen J Orthop Trauma 2005 19 10 16 Hadjiargyrou M McLeod K Ryaby JP Rubin C Enhancement of fracture healing by low
36. reatment After treatment is complete you must clean the transducer after each use Treatment Data The Treatment History Screen shows your treatment summary Today s day will have a purple box around it EXOGEN will mark every day with one of the following symbols X mark checkmark double checkmark double checkmark plus or partial treatment Track Usage EXOGEN tracks how often you use it Your usage will be shown on the screen which displays 42 treatment days on each screen There are two parts to the screen The top part shows a treatment data grid and the bottom part shows the treatment O LUI A TE gt lt Lu 10 summary information See Figure 8 Symbol Name Description l X mark You did not complete a treatment 1 Squeeze tabs to open the cap on 2 Gently remove the transducer from the 3 Wipe off any gel on the transducer 4 Remove the strap and clean any gel from on this day the port port Do not yank the cord Pulling hard with a soft cloth You do not need your skin and strap with a soft cloth on the cord to remove the transducer any cleaning fluid See eee eee Checkmark You completed a 20 minute treatment may cause the cord to detach from the i d d EXOGEN back into the carrying case until you on this day ransducer and require your l are ready to treat again to be serviced 4 1 A x 134 14 Treatment 15 16 17 18 19 20 21 data Doubl checkmark You completed two 20 minute tre
37. s treated with opening wedge high tibial osteotomy by hemicallotasis J Bone Joint Surg Am 2004 86 A 2399 2405 Uchiyama Y Nakamura Y Mochida J Tamaki T Effect of Low Intensity Pulsed Ultrasound Treatment for Delayed and Non union Stress Fractures of the Anterior Mid Tibia in Five Athletes Tokai J Exp Clin Med 2007 32 121 125 Warden SJ Bennell KL McMeeken JM Wark JD Acceleration of fresh fracture repair using the sonic accelerated fracture healing system SAFHS a review Calcif Tissue Int 2000 66 157 163 Yoshitaka H Toshiharu S Osamu U Toshifumi K Kazuhisa B Effect of low internisty ultrasound on severe open fractures Seikei Geka Orthopaedic Surgery and Traumatology Japanese language 2003 46 1 67 73 Emami A Petren Mallmin M Larsson S No effect of low intensity ultrasound on healing time of intramedullary fixed tibial fractures J Orthop Trauma 1999 13 252 257 Rue J P Armstrong D W 3rd Frassica F J Deafenbaugh M Wilckens J H The effect of pulsed ultrasound in the treatment of tibial stress fractures Orthopedics 2004 27 1192 1195 Gersten JW Effect of metallic objects on temperature rises produced in tissue by ultrasound Am J Phys Med 1988 37 75 82 Handolin L Pohjonen T Partio EK Arnala Tormala P Rokkanen P The effects of low intensity pulsed ultrasound in bioabsorbable self reinforced poly L lactide screw Biomaterials 2002 23 2733 2736 Lehman J et al Ultrasonic
38. sh fractures Internationally EXOGEN can be used on both fresh fractures and non unions and both can be conservatively or surgically treated EXOGEN transmits a low intensity ultra sound signal to the fracture site through coupling gel with little or no sensation felt by the patient during the treatment Low intensity pulsed ultrasound has been shown in in vitro and in vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing The patient administers treatment at home or at work once daily for 20 minutes or as prescribed by a physician Charger EXOGEN automatically alerts the patient in case of improper application or performance The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device a charger a gel bottle a strap and a Treatment Card The EXOGEN device provides the treatment control circuitry the battery supply and monitors the operation of the transducer at the fracture site The signal specifications cannot be changed Everything you need to treat your fracture is included in the EXOGEN Ultrasound Bone Healing System See Figure 1 Your charger may look different from the image below depending on the country where you live If one of the items in Figure 1 is missing please contact Customer Service to receive a replacement EXOGEN Device EXOGEN Figure 2 features a transducer at the end of a coiled cord color screen power button USB c
39. tory Screen 3 Customer Service Australia 1800 428 220 Ireland 1800 552197 UK 0800 0516384 13 14 Replacing Your Treatment Card If you have used all the treatments on your Treatment Card and you feel your fracture has still not healed please contact your doctor If you are still under your doctor s care they may prescribe you another Treatment Card To order a replacement Treatment Card please contact Customer Service Once you receive your replace ment Treatment Card follow the instructions to replace your old card Cover closed Make sure your device is turned off and not plugged into a power source Find the cover on the right side of EXOGEN Pull down at tab to open 3 Pull down the tab to open the cover Treatment Card metal contacts facing up 4 Press the Treatment Card inward until it clicks and then release your finger from the Treatment Card The card should eject from the device far enough for you to grab it 5 Remove the Treatment Card from EXOGEN and discard 6 Put the new Treatment Card into the port metal contacts facing up and entering first Press the card into EXOGEN until the card clicks into place 7 Close the cover 8 Leave your Treatment Card in EXOGEN until all your treatments have been used Troubleshooting EXOGEN will alert you if something is not working properly EXOGEN will beep and display an alert screen See the table below f
40. ure 7 You may charge EXOGEN at any time whether it is on or off When the battery level is low you must charge EXOGEN before your next treatment You can charge EXOGEN and treat your fracture at the same time Use the charger provided in the EXOGEN Ultrasound Bone Healing System Do not connect EXOGEN to any other electrical equipment EXOGEN is unable to communicate with any other electrical equipment USB Cover closed 1 Find the USB cover on the left side of EXOGEN Battery status Charging symbol 5 You will see the charging symbol white lightning bolt and battery status symbol flashing in the corner of the screen This lightning bolt charging symbol tells you EXOGEN is charging Charge EXOGEN until a fully charged battery is shown by the battery status Full Charge Partial Charge Partial Charge Low Charge Figure 7 Battery Status Symbols si Pull down at a tab to open USB Cover open 2 Pull the tab down to open the USB cover 6 When charging is complete remove the USB plug from EXOGEN close the USB cover and unplug the charger from the wall USB plug of charger 3 Plug the end of the charger into an electrical outlet Plug the USB plug end of the charger into the USB port BATTERY PROBLEM Try fully charging EXOGEN with the charger provided If your EXOGEN unit still does not work call Customer Service Do not try to fix EXOGEN yourself
41. use the supplied gel Do not use other gels as they may damage the transducer surface or block the signal If you need more gel please call Customer Service Note Some patients have experienced mild skin irritation caused by skin sensitivity to the gel If you feel your skin is sensitive to the gel you may change the gel to mineral oil or glycerin Cap Nozzle Bottle h Sound Coupling amp t Ube y pot n EXOGEN ultrasound q System q ternal use only iy N long for use as Lys to the EXOGEN Ins gg PPlication guidelines P on bottle after use PT Figure 5 Ultrasound Coupling Gel Part Number Part 71034694 Treatment Card EXOGEN comes with a Treatment Card Figure 6 Based on your physician s prescription the amount of treatments on your card may vary Once the card is inserted EXOGEN will show you how many treatments you have used on your card EXOGEN will only work properly if the card is inserted The card must remain inside of EXOGEN until all treatments are used Only use the Treatment Card supplied by Bioventus Do not insert other cards in EXOGEN Other cards may become damaged when inserted into EXOGEN If you have not received a Treatment Card with your EXOGEN contact Customer Service A selection of Treatment Cards are available depending on your country of residence Metal Contacts Treatment Card Figure 6 Treatment Card EXOGEN Usage EXOGE
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