EXOGEN 4000+ Ultrasound Bone Healing System
Contents
1. ale o Instructions 77 smith amp nephew for Use EXOGEN 4000 Ultrasound Bone Healing System CAUTION Federal Law U S A restricts this device to sale distribution or use by or on the order of a physician or properly licensed practitioner The device is only intended for use by the individual for whom it is prescribed Symbol Summary Tables Equipment Classification and Device Symbol Descriptions Information Symbol refer to Instructions for Use CE Mark indicates conformity with European Council Directive of 14 June 1993 0086 concerning Medical Devices 93 42 EEC EU Not for General Waste This symbol indicates that this device should not be disposed of with ordinary household waste at the end of its life For details on how to dispose of this device correctly contact your local government waste disposal agency or your local Smith amp Nephew representative oo d vr EC Rep Symbol indicates the authorized representative in the European Community SN Serial number first four digits of the serial number indicate the month and year of manufacture Rx Symbol Federal Law U S A restricts this device to sale distribution or use Kony by or on the order of a physician or properly licensed practitioner This device is only intended for use by the individual for whom it is prescribed EXOGEN is a Class B digital apparatus which meets all requirements of the Canadian Interference Causing Equipment Regulations2. EXOGEN est un appareil de classe B qui r pond a toutes les exigences des R gulations Canadiennes sur les quipements pouvant causer des interf rences Table of Contents INTRODUCTION TO THE EXOGEN 4000 ULTRASOUND BONE HEALING S STEN ossei Ea INDICAUONS FOR USE iposi nesa i an EE E EE CONTRAINDICAT ONS epris epn EERE PE EEEE WARNINGS 05 PRECAUTIONS COMPLICATIONS ADVERSE EVENTS DEVICE DESCRIPTION SOTEM COMPONENTI cessere Er rE E 3 TREATMENT SCHEDULE oa passcctepcenssovrgrn tions nen En nn 4 DEVICE LIFE 000 TREATMENT TIME VISUAL AND AUDIO INDICATORS eee eeeeeereeeeeeeeeeeeees 5 DEVICE APPLICATION FO SMO MIS THE SIRAP paroiis nr EON APPLYING THE DEVICE WHEN YOU HAVE A CAST cccccceceeeessesssssseeees APPLYING COUPLING GEL cccccccccscsecesesecccceccccsseseeseeesessssessssseaeees DEVICE OPERATION sass nosisavpesaecsstsasarieesaieaonnes tasnseeeasuioraates TURNING THE UNIT ON AND OFF ccccccccccceccucesccuceuscecceuseusceees WHEN TREATMENT IS COMPLETE 0c ccccccsccceccsccceccscecscccecescesceuscs CARE AND CLEANING ec eee cecceeeceeeneeeeeeeeeeeeeeteeeeaeeeaes OPERATION STORAGE AND TRANSPORT 000000 eee eee D ks O S 4 eevee re err rererr rrrersere tren renner Terre errr te EIS VINCE EE EEE E E E For additional information on the EX
3. open Grade II or Ill fractures with large wounds or that require surgical intervention with internal or external fixation screws and or plates used to hold your broken bones in place or that are not sufficiently Stable for closed reduction manipulation of the fracture without surgery and cast immobilization cast treatment Precautions e The device will not correct or alter post reduction when your fracture is initially set and placed in a cast aspects of a fracture such as displacement angulation or malalignment e The operation of active implantable devices such as cardiac pacemakers may be adversely affected by close exposure to the EXOGEN device The physician 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 the EXOGEN device e Cell phones televisions and other devices using radio frequency energy may cause interference While the EXOGEN device 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 e The safety and effectiveness of the EXOGEN device when used for more than one daily 20 minute treatment period has not been studied Patients in the clinical studies were instructed to apply the device for one treatment period of twenty minutes each day e The age ranges of the patients in the PMA non union
4. studies were 17 86 The effect of EXOGEN therapy on patients outside this age range has not been studied e The age ranges of the patients in the PMA fresh fracture studies were 17 67 The effect of EXOGEN therapy on patients outside this age range has not been studied e The safety and effectiveness of the use of this device has been demonstrated for patients followed up over a period of 6 5 years 78 months Complications No device related adverse reactions or medical complications related to the use of this device were reported during the clinical studies Some patients have experienced mild skin irritation caused by skin sensitivity to the coupling gel Resolution can be obtained by a change of coupling medium to mineral oil or glycerin In the distal radius study one patient complained of pain during treatment but this resolved by the next follow up visit and one patient complaining of pain withdrew from the study Adverse Events The ultrasound intensity is comparable to diagnostic ultrasound such as the intensities used in obstetrical sonogram procedures fetal monitoring Unlike conventional physical therapy ultrasound devices the EXOGEN device is incapable of producing harmful temperature increases in body tissue In addition there is no evidence of non thermal adverse effects Device Description The EXOGEN device is designed for ease of use at home and is comprised of a main operating unit with a permanently c
5. the fracture site as marked by your physician You should be able to see the mark on your skin through the round opening Figure 4 4 Tighten the strap utilizing hook and loop to hold position Be careful not to overtighten Figure 4 Applying the Device when you have a Cast Your physician or cast technician will prepare your cast for EXOGEN treatment by installing the plastic cap assembly into your cast 1 Using 2 fingers gently squeeze the flanges on the sides of the cap installed in your cast and open the cap as indicated in Figure 3 on the previous page 2 Remove the round felt plug from the cast opening Figure 5 Figure 5 Applying Coupling Gel 1 2 3 Remove the top from the coupling gel bottle Hold the transducer where the cable meets the transducer Place your finger on the gel bottle pump and press down to apply one pump of gel onto the transducer face Note The first time you use the gel you may need to pump a few times to get the gel flowing Figure 6 Place the transducer into the cap opening The gel should be touching the skin Figure 7 Align the cord in the U shaped cutout in the cap and snap the cap closed on the strap or on the cast Figure 8 amp 9 Replace the top on the gel bottle Figure 6 Figure 8 Figure 7 Figure 9 Device Operation 3 The device will then display the total number of PARTIAL treatments 4 The device will then start ultraso
6. OGEN device please visit our website at www exogen com THIS DEVICE IS NON STERILE IT DOES NOT REQUIRE STERILIZATION PRIOR TO USE Introduction to the EXOGEN 4000 Ultrasound Bone Healing System The EXOGEN 4000 Ultrasound Bone Healing System provides a non invasive therapy for healing non unions or accelerating the healing of fresh fractures The EXOGEN device delivers safe low intensity pulsed ultrasound through a coupling gel to a broken bone The low intensity pulsed ultrasound has been shown in laboratory studies to stimulate cells to produce growth factors and proteins that are important to bone healing PLEASE BE SURE TO READ THE ENTIRE MANUAL BEFORE USING The EXOGEN 4000 Ultrasound Bone Healing System Indications for Use The EXOGEN 4000 or any other EXOGEN Ultrasound Bone Healing System is indicated for e The non invasive treatment of established non unionst excluding skull and vertebra e Accelerating the time to a healed fracture for fresh closed posteriorly displaced distal radius fractures fractures of the end of the large bone in your forearm and fresh closed or Grade open tibial diaphysis fractures fractures in the middle 80 of the large bone in your lower leg in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization adult individuals eighteen years of age or older who have fractures with or without minor skin wounds that ar
7. count down the 20 minutes of treatment time when you push the On Off button and it will automatically shut itself off with an audible beep when the 20 minute treatment is complete The device also has an internal patient usage monitor that records the date and time of each treatment This record can be made available to your physician so that he or she can monitor your compliance Your physician will determine when your fracture is healed Each patient and fracture is unique and it takes some fractures longer to heal than others Note The 20 minute treatment time may be interrupted for up to 30 seconds if necessary Do not push the orange On Off button Remove the transducer from your skin attend to your interruption reapply coupling gel to the transducer as necessary and return the transducer to your skin If the interruption is longer than 30 seconds the device will turn off and you will need to begin a new 20 minute treatment Visual and Audio Indicators Symbol Alarm Meaning Next Steps Meaning The device has encountered a fault condition Attention symbol shown with a Next Steps Wait 1 minute Turn the device on by pressing the beeping tone lasting for 30 seconds orange On Off button If the device still displays the Attention then the device turns off symbol call Smith amp Nephew Customer Services for service see Service Meaning Add coupling gel to the transducer face Add Gel symbol blinks with a Next Steps Re
8. e placed in a cast for treatment A non union is considered to be established when the fracture site shows no visibly progressive signs of healing Contraindications There are no known contraindications to the use of this device Warnings The safety and effectiveness of the use of this device 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 e Pathological fractures due to bone pathology or malignancy fractures due to disease e Pregnant or nursing women e 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 e Individuals receiving steroid anti coagulant prescription Warnings continued e 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 e Fresh fracture locations other than the distal radius end of the large bone in the forearm or tibial diaphysis middle 80 of the large bone in your lower leg e Fresh fractures that are
9. ing gel on the transducer surface and alerts the patient with an audible beep if gel is not present The MOU maintains a complete record of patient daily use of the device which is available to the physician The transducer transmits low intensity pulsed ultrasound to the skin at the fracture site through a coupling medium The gel bottles supplied with the device contain the appropriate ultrasound coupling gel Alternatively mineral oil or glycerin can be substituted for the gel provided Note EXOGEN Ultrasound coupling gel supplied is the recommended gel for use with this system Do not substitute other gels as they may damage the transducer surface or impede signal transmission Please call the Clinical Therapies Service Center 1 800 836 4080 of Smith amp Nephew Inc if you need more coupling gel The Strap is designed to hold the transducer over the fracture site When closed it applies light pressure to the top of the transducer to maintain skin contact Treatment Schedule Device Life The EXOGEN device is powered by a non replaceable non rechargeable lithium battery pack with a life of a minimum of 150 treatments of 20 minutes each If your EXOGEN device requires a battery service before your fracture is healed please call the Clinical Therapies Service Center 1 800 836 4080 Treatment Time The EXOGEN device should be worn for 20 minutes per day or as prescribed by your physician The EXOGEN 4000 device will
10. move the transducer from the strap or cast Add beeping tone that lasts for 30 one pump of coupling gel to the transducer face that will touch seconds then the device turns off your skin Place the transducer to your skin in the strap or cast If the device has turned off press the orange On Off button Pulsing Treatment symbol which Meaning Ultrasound treatment is being delivered and device is pulses as the timer counts down functioning properly Treatment Stop symbol displays briefly with 2 tone beep and device Meaning 20 minute treatment has been completed turns off Digital numbers displayed on screen Meaning Device is running a 2 second self test Meaning Device is counting treatment time down from 20 Digital numbers displayed on screen mines Device Application Before you begin treatment with the EXOGEN 4000 your physician will place a mark on your skin over your fracture to indicate where you should position the EXOGEN 4000 transducer To begin a 20 minute treatment with the EXOGEN 4000 you will need Figure 2 e The EXOGEN 4000 main operating unit e A bottle of EXOGEN coupling gel e The strap Positioning the Strap 1 Hold the strap with the EXOGEN cap side up and pull the end of the strap up through the bottom of the loop Figure 2 Figure 3 2 Using 2 fingers gently squeeze the flanges on the sides of the cap to open the cap Figure 3 3 Position the strap so the cap is placed directly over
11. nited States Call 1 800 836 4080 option 2 In the European Community Call 49 746 22080 In all other countries Call 1 901 396 2121 USA and ask for Clinical Therapies service Center Questions regarding where to place the device for treatment fracture healing issues with casts or other medical issues should be addressed to your physician Authorized European Community EC Representative Smith amp Nephew Orthopaedics GmbH Alemannenstrasse 14 78532 Tuttlingen Germany Telephone 49 746 22080 Fax 49 746 2208135 13 In the USA Smith amp Nephew Inc 1450 E Brooks Rd Memphis TN 38116 USA Telephone 1 901 396 2121 1 800 836 4080 In Other Countries Call USA Telephone 1 901 396 2121 Copyright 2006 Smith amp Nephew Inc Trademark of Smith amp Nephew Reg US Pat amp TM Off Product No 81068937 Rev 0 11 09
12. onnected transducer a strap and coupling gel see figure 1 Itis lightweight and portable with a large visual display and audible tones to give information during treatment Transducer Figure 1 C Q x f i Da Gel Bottles Main Operating Unit MOU Strap Use the EXOGEN device for 20 minutes a day or as prescribed by a physician You should continue using the EXOGEN 4000 device until your physician determines that your fracture is sufficiently healed The intensity of the ultrasound signal is low similar to diagnostic ultrasound intensities used in sonograms fetal monitoring The main operating unit provides the treatment control circuitry the primary battery supply and also monitors the operation of the transducer at the fracture site To ensure the device is functioning properly the EXOGEN device main operating unit constantly monitors the ultrasound signal delivery The unit is functioning correctly if the numbers are counting down If at any time the device stops functioning properly an Attention signal will appear on the screen Neither you nor your physician can change the ultrasound specifications or service the device system Components The Main Operating Unit MOU is powered by a non replaceable lithium battery The MOU self monitors controls system operation during treatment and verifies correct operation of the transducer The device monitors the presence absence of coupl
13. orporate complex electronic technology to deliver its low intensity pulsed ultrasound treatment and should be handled with care Please note the following Do not attempt to modify or repair the EXOGEN device There are no user serviceable parts inside the device Use only a clean soft cloth paper towel or cotton swab to clean the transducer or strap Do not use cleaning agents or solvents on any of the components of the system Never immerse the unit in water Care and Cleaning continued e Donot expose the EXOGEN device to extreme temperatures or the internal electronic components may be damaged e Exercise care when handling the transducer as rough handling may adversely affect the device s operation e Donot store near radiators or extreme heat e Aswith any home electronic device protect the EXOGEN 4000 device from impact exposure to moisture liquid spills sand dirt or debris e Periodically inspect the cable and the transducer for any cracks or signs of damage Operation Storage and Transport The EXOGEN device should be operated within Ambient temperature range 50 F 10 C to 104 F 40 C Relative humidity range 30 to 75 Atmospheric pressure range 700 hPA to 1060 hPA The EXOGEN device should be stored and transported within Ambient temperature range 32 F 0 C to 122 F 50 C Relative humidity range 30 to 75 Atmospheric pressure range 700 hPA to 1060 hPA If the device is stored or transp
14. orted in temperatures outside this range allow the device time to come to room temperature before operating Interference with proper operation of the EXOGEN 4000 device may occur in the vicinity of equipment such as portable and mobile communication units marked with this symbol CD If abnormal operation of the device is observed attempt to relocate or reorient the device in relation to the interfering equipment Disposal Follow your local refuse laws to dispose of the EXOGEN 4000 unit The EXOGEN unit is for single patient use ONLY Dispose of batteries properly to prevent injury Do not throw into fire Service Smith amp Nephew Clinical Therapies Service Center is available to answer questions regarding use of the EXOGEN 4000 device and to handle any servicing needs Call 1 800 836 4080 option 2 If your unit shows the Attention symbol or otherwise needs service please follow these instructions 1 Call Smith amp Nephew Clinical Therapies Service Center describe the problem and request a Return Authorization RA number 2 Pack the device in its original packaging Otherwise pack the device to prevent movement during shipping 3 Label the box with this address Smith amp Nephew Inc 1450 E Brooks Rd Memphis TN 38116 4 Complete the shipper airbill supplied with your device and contact the freight company to arrange pickup To Contact Smith amp Nephew Clinical Therapies Service Center In the U
15. und treatment The timer Turning the Unit On and Off countdown begins at 20 minutes and there will be a Pulsing Treatment symbol 5 The unit is delivering ultrasound provided the numbers are counting down Once the 20 minute treatment countdown has reached zero the device will emit a 2 tone beep and turn itself off When Treatment is Complete 1 Open the cap 2 Remove the transducer and clean any excess gel with a soft cloth Figure 11 Figure 10 Firmly press then release the orange On Off button on the EXOGEN 4000 to turn the device on Figure 10 When the device is on a sequence of status symbols will display momentarily as follows 1 The device will emit a 2 tone beep and show all the symbols on the display at once while it runs a 2 second self test 2 The device will then display the total number of COMPLETE treatments delivered Figure 11 3 Remove the strap and clean any excess gel from your skin and strap Figure 12 If using with a cast a Carefully clean any excess gel from your cast b Replace the round felt plug with the tab on top into the cap opening This is important to prevent swelling in the cast opening when you are not using EXOGEN Figure 13 4 Place unit and accessories into EXOGEN system tote until the next treatment time Figure 13 Care and Cleaning While the EXOGEN 4000 Ultrasound Bone Healing System has been designed for your ease of use it does inc
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