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PATIENT PROGRAMMER 37743

1. 77 77 x t ebueuo o Moy 1noge xutui 440 10je nuunso4nau y UINL 7E or yopeinuns juouno eu UM eJnjsod 10 1ueAno INOA 104 lqelins 104 00 ale NOA s um s uonejnuims 10 dnos6 pejosjes y uonejnuuns ejqeuojuioouf Suonoe pue s sneo sul lqold suie qoud BunoousejqnoJ Y S lqEL G Sunoous lqnol English 37743 2007 09 132 G Bunoousejqnoi ueu ANOA 1981u09 431131 ured eyenbope Hura JOU 94e NOA JI 19A9M0H S EAH TU Tejn68J ye 440 pue NO un o JojejnuumnsoJneu Jno ACW ueniu INOA euin eui jo awos Ajuo uonejnuuns jae no uone nuuns uayuu 440 p u n s 10 e numsouneu ay Jaye 129 J8 ienpis l e Aew noA 440 pue NO Uun o 101ejnumsouneu 4no4 so Spuooes g 1noqe Moy sdojs pue sues uonejnuuns 181 os doig ueisSuos ueniu 1 5 pue s sneo J0jejnuimsouneu eui 4 0 Buiuum uorne nuuns NOA 10 eui NO bulun aye Aeme pyp uomnejnuiJns JOU op noA seDueuo 5 po ejog sul lqold penuguoo suiejqoud Gunoouse qnoJ ps 133 37743 2007 09 English s epnujduie v ose23Joul o JowWWeIHOJd 1uened noA asp 99J 01 MO 00 195 aye dnoJ6 y Ul ureJ60Jd uoee 40 sepnijdure eu NO uonejnuins usm pue dno46 Jayjoue 129
2. 8 Figure 4 27 Place the antenna over your neurostimulator 2 Pull the fabric of your clothing through the large opening in the antenna Then wedge the fabric in the narrow slit to secure the antenna in place Figure 4 28 Figure 4 28 Pull the fabric through the slit a and wedge in place b Using your patient programmer 4 112 English 37743 2007 09 3 Push the antenna plug firmly into the antenna jack Y on the patient programmer Figure 4 29 Figure 4 29 Insert the antenna plug into the antenna jack Using the antenna After the antenna is connected follow the instructions for using the patient programmer When you have finished using the patient programmer grasp the antenna plug and pull it out Caution Do not pull directly on the antenna cable to disconnect the cable from the programmer because this may damage the antenna cable 37743 2007 09 English Using your patient programmer 4 y 1uened ano Durs English 37743 2007 09 114 Troubleshooting 5 116 This chapter will help you solve problems with your patient programmer It also provides information on when to call your clinician Note If you cannot solve a problem or if your problem is not described here contact your clinician Patient programmer screens The patient programmer displays warning A communication X and information screens to pr
3. Using your patient programmer 4 A those electrodes that are active deliver the electrical pulses Specific combinations or positions of active electrodes will deliver stimulation to a very specific pain site TARGETmyStim allows you to try specific electrode positions to determine which is best for your pain The numbers on the TARGETMYSTIM icon represent the electrode position for a program in the active group and the number of adjustments available Figure 4 18 on 93 For example 3 5 means the electrodes are in position 3 out of a possible 5 positions The number of available positions will vary depending on how your clinician programmed your neurostimulator When the INCREASE or DECREASE key is selected the TARGETMYSTIM screen is displayed showing the current position and the selected position Figure 4 19 English 37743 2007 09 e PEZA Figure 4 19 TARGETMYSTIM screen Hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key The THERAPY screen appears Verify that the group is active V and the selection box is located on the TARGETMYST M icon on the Parameter row Figure 4 18 on page 93 Hold the patient programmer over your neurostimulator and press the INCREASE or DECREASE C key The TARGETMYSTIM screen appears Hold the patient programmer over your neurostimulator and press the INCREASE or DECREASE x key to ch
4. Important therapy information 2 N cx Important therapy information 2 N N Risks and benefits Stimulation has helped thousands of patients manage their pain and improve their quality of life Your neurostimulation system may be used with other pain treatments Stimulation will not cure your pain It can however reduce your pain to a tolerable level and allow you to resume many of your daily activities Risks of surgery Implanting a neurostimulation system has risks similar to spinal procedures including spinal fluid leak headaches swelling bruising bleeding infection or paralysis If you are on anticoagulation therapy you might be at greater risk for postoperative complications such as hematomas that could result in paralysis English 37743 2007 09 Possible adverse effects Adverse effects of stimulation are usually mild and go away when stimulation is turned OFF These adverse effects could include radicular chest wall stimulation uncomfortable stimulation a jolting or shocking sensation or persistent pain at the neurostimulator site Changes in therapy Over time there could be changes in the level of your symptom control In most cases your doctor can correct these changes without surgery Possible system complications The lead extension or neurostimulator could migrate within the body or erode through the skin There could be undesirable changes in stimulation possibly related to cellul
5. 37743 Pain therapy user manual for the Model 37701 RestorePRIME Model 37702 Prime ADVANCEDS Model 37711 Restore Model 37712 RestoreULTRA Model 37713 RestoreADVANCED neurostimulation systems Medtronic PrimeADVANCEDS Restore RestoreADVANCED and RestorePRIME are registered trademarks of Medtronic Inc GROUPADJUST RestoreULTRA SoftStart Stop and TARGETmyStim are trademarks of Medtronic Inc rusa FCC Information The following is communications regulation information on the Model 37741 Patient Programmer FCC ID LF537741 This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation IMPORTANT Changes or modifications to this product not authorized by Medtronic Inc could void the FCC Certification and negate your authority to operate this product Label symbols Explanation of symbols on products and packaging Refer to the appropriate product to see symbols that apply CE Conformit Europ enne 0123 0123 European Conformity This symbol means that the device fully complies with AIMD Directive 90 385 EEC NB 0123 and R amp TTE Directive 1999 5 EC Qo The use of this device might be subject to individual country licensing regimes in Europe OS
6. Refer to the Medtronic contacts at the end of this manual Battery and programmer disposal Dispose of depleted batteries and worn out devices according to local requirements If you no longer need your programmer and would like to donate it contact your clinician English 37743 2007 09 Neurostimulator disposal The implanted device should be removed before burial or cremation In some countries removal of battery powered implantable devices is required before burial because of environmental concerns Also the device should be removed before cremation The cremation process causes the battery to explode Explanted devices should not be resterilized or reimplanted Declaration of conformity Medtronic declares that this product is in conformity with the essential requirements of Directive 1999 5 EC on Radio and Telecommunications Terminal Equipment and Directive 90 385 EEC on Active Implantable Medical Devices For additional information contact Medtronic Refer to the list of Medtronic contacts at the end of this manual 37743 2007 09 English Maintenance 6 AZ Specifications Table 6 1 Patient programmer specifications Item Specification Power source 2 AAA alkaline batteries non rechargeable LR03 Operating 9 C to 43 C 49 F to 1109F temperature Storage 40 C to 65 C 40 F to 150 F temperature Operating storage 30 to 95 relative humidity Operating storage 70 kP
7. Electromagnetic interference 152 e The neurostimulator should be turned OFF before using electrocautery Bipolar cautery should be used e f unipolar cautery is necessary only low voltage modes should be used the lowest possible power setting should be used the current path ground plate should be kept as far away as possible from the neurostimulator extension and lead full length operating room table grounding pads should not be used e After electrocautery your doctor should confirm that the neurostimulator is vvorking as intended High output ultrasonics lithotripsy Use of high output ultrasonics or lithotripsy is not recommended if you have an implanted neurostimulation system f lithotripsy must be used the beam should English 37743 2007 09 not be focused within 15 cm 6 in of the neurostimulator Magnetic resonance imaging MRI An MRI examination of the head only may be safely performed under certain specific conditions However Medtronic recommends that an MRl using a radiofrequency RF transmit body coil should not be prescribed for you if you have any part of an implanted neurostimulation system Exposing you to an MRI using a radiofrequency RF transmit body coil or not following the specific conditions indicated above can cause tissue damage and can result in severe injury or death Please have your health care professional contact Medtronic for specific
8. Settings adjusting stimulation 85 96 Skiing 35 Skydiving 35 SoftStart Stop 133 Specifications 144 Index 37743 2007 09 English 179 Index 180 Status row 61 100 102 Status row icons 62 Stimulation adjusting settings 85 96 description 40 troubleshooting 132 134 uncomfortable 77 132 unexpected changes 35 77 82 Sync key 59 97 Synchronize warning screen 117 Synchronizing 58 59 97 TARGETmyStim function 93 96 Test stimulation 43 Theft detectors 156 Therapy screen 60 Therapy screen icons 62 63 64 Time format preference 99 104 Time preference 99 104 Tones audio 80 116 123 Transcutaneous electrical nerve stimulation TENS 161 Turning neurostimulator ON or OFF 77 97 Twiddler s Syndrome 34 Ultrasonic probes 158 Ultrasonics high output 152 Ultrasound 163 Uncomfortable stimulation preventing 77 troubleshooting 132 Unexpected changes in stimulation 35 82 English 37743 2007 09 Unexpected stimulation preventing 77 Upper limit 88 Warning screens 116 120 Warnings 24 31 X rays 164 Index 37743 2007 09 English 181 Index 182 English 37743 2007 09 Contacts Asia Medtronic International Ltd Tel 02891 4068 Fax 02591 0313 Medtronic Asia Ltd Tel 02 548 1148 Fax 02 518 4786 Australia Medtronic Australasia Pty Ltd Tel 02 9879 5999 Fax 02 9879 5100 Austria Medtronic sterreich GmbH Tel 01 24044 Fax 01 24044 100 Belgium Medtronic Belgium S A Tel 02 456 090
9. Signal from foot Figure 3 1 Stimulation blocks some of the pain signals as they move to the brain English 37743 2007 09 Note Stimulation will not cure your pain nor will it block sharp pain caused by a recent injury To most patients the pulses feel like a steady tingling sensation in the painful area Figure 3 2 Area of pain Area of stimulation Figure 3 2 Stimulation feels like tingling in the area of pain Generally people experience a fairly constant sensation of stimulation However you may feel changes when you suddenly move or change position 37743 2007 09 English Introduction to stimulation 3 A Introduction to stimulation 3 N Parts of your system A typical neurostimulation system has implanted parts that deliver the electrical pulses to the area where your pain signals are blocked Typically the implanted parts are a neurostimulator one or two leads and one or two extensions optional Figure 3 3 Neurostimulator Extensions TTTHTHTRF Q7 ae Leads x N I Figure 3 3 Implanted parts of a typical neurostimulation system A typical neurostimulation system also includes an external patient programmer for controlling your system If you have a English 37743 2007 09 rechargeable neurostimulator your system also includes a charging system Figure 3 4 Patient programmer Charging system rechargeable neurostimulator Detach
10. 2007 09 a If two security gates are present walk through the middle keeping as far away as possible from each gate b If one gate is present walk as far away as possible from it Double Security Single security gate stay as gate far as possible from gate Figure 7 1 Approaching security gates Note Some theft detectors might not be visible Proceed through the security device Do not linger near or lean on the security device After you pass through the security device turn your neurostimulator ON again 37743 2007 09 English Appendix A Electromagnetic interference N Appendix A Electromagnetic interference 158 Precautions EMI from the following equipment is unlikely to affect your neurostimulation system if the guidelines below are followed Bone growth stimulators The coils of an external magnetic field bone growth stimulator should be kept 45 cm 18 in away from the neurostimulation system When a bone growth stimulator is used your doctor should ensure that both the bone growth stimulator and neurostimulator are working as intended Dental drills and ultrasonic probes The neurostimulator should be turned OFF and the drill or probe should be kept at least 15 cm 6 in away from the neurostimulator Electrolysis The neurostimulator should be turned OFF and the electrolysis wand should be kept at least 15 cm 6 in away from the neurostimulator English 37743 20
11. 3 5 Alex chooses whichever group he requires English 37743 2007 09 Group A Group B Low back and thigh pain Low back thigh and ankle pain Figure 3 5 Example of programs and groups Controlling your stimulation Your neurostimulator only accepts programming from the clinician programmer or patient programmer other devices are not able to program your neurostimulator 37743 2007 09 English Introduction to stimulation 3 A Introduction to stimulation 3 What your clinician controls Your clinician uses a clinician programmer to communicate with your neurostimulator Your clinician designs programs and groups according to your needs Your clinician can also specify the settings that you will be able to adjust with your patient programmer Discuss this with your clinician What you control As your activities vary throughout the day your therapy needs may change The patient programmer allows you to turn stimulation ON and OFF switch from one group to another and adjust the amplitude pulse width or rate for each program in the active group Talk to your clinician about the settings that apply to your therapy English 37743 2007 09 Charging a rechargeable neurostimulator Note This section applies only to a neurostimulator with a rechargeable battery If your neurostimulator is non rechargeable continue with Recovery and care on page 51 It is critical that you charge your neuro
12. System meets the applicable Canadian TUV C22 2 601 1 M90 R2001 and US v UL 60601 1 2003 electrical safety standard requirements N Caution consult accompanying documents SN Serial number Jt Storage temperature Relative humidity 37743 2007 09 English Label symbols Label symbols A XXX HPa XXX in Hol Xx HPa XXX in Ho Q Y G Atmospheric pressure IEC 60601 1 EN60601 1 Type BF Equipment Non ionizing electromagnetic radiation Screen light Antenna jack For USA audiences only Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations See http recycling medtronic com for instructions on proper disposal of this product Chinese Standard SJ T11364 2006 Logo Electronic Information Products Pollution Control Symbol The date in this logo means the environmental protection use period of the product English 37743 2007 09 Contents Label symbols 3 Introduction 11 A company dedicated to patients 12 How to use this manual 13 Patient guides 15 Patient identification card 18 Important therapy information 19 Purpose of the device 20 Purpose of the neurostimulation system indications 21 Therapies that may not be used with the neurostimulation system contraindications 21 Risks and benefits 22 Risks of surgery 22 Pos
13. an electrical pulse Rate The number of electrical pulses delivered each second Settings See Stimulation settings Glossary 37743 2007 09 English 169 Glossary 170 SoftStart Stop This feature programmed by your clinician starts and stops stimulation gradually by slowly increasing or decreasing to the programmed amplitude or OFF Spinal cord This is your body s information center Nerve signals from the entire body travel to your spinal cord and then to your brain Status row The top row on the THERAPY screen Icons represent information about the neurostimulator and the patient programmer Stimulation The delivery of electrical pulses to the area where pain signals are blocked as they move to the brain Stimulation blocks some pain signals from reaching the brain Stimulation settings Refers to all the features assembled to define the stimulation you feel The clinician programs all stimulation You can adjust some stimulation settings within clinician defined limits English 37743 2007 09 Synchronize The process of sending and receiving information between the patient programmer and neurostimulator Test stimulation The period of time when an external neurostimulator is used to determine if stimulation blocks the pain signals effectively Therapy Treatment of a disease or condition When neurostimulation therapy is prescribed a neurostimulation system is used
14. bleach nail polish remover mineral oil or similar substances and do not drop it or mishandle it in a way that may damage it Patient device use The device is not certified for use in the presence of a flammable or anesthetic mixture with air or with oxygen or nitrous oxide The consequences of using the device near flammable atmospheres are unknown 37743 2007 09 English Important therapy information 2 Important therapy information 2 c A Patient activities Activities requiring excessive twisting or stretching Avoid activities that put undue stress on the implanted components of your neurostimulation system Activities that include sudden excessive or repetitive bending twisting bouncing or stretching can cause parts of your neurostimulation system to fracture or migrate This can result in a loss of stimulation intermittent stimulation stimulation at the fracture site and additional surgery Spinal cord stimulation patients in particular should avoid excessive bending of the torso Component manipulation Do not manipulate or rub your neurostimulation system through the skin this is sometimes called Twiddler s Syndrome Manipulation can cause damage to your system lead dislodgement skin erosion or stimulation at the implant site If you have a rechargeable neurostimulator manipulation may also flip your device so that it can t be charged English 37743 2007 09 Scuba
15. diving or hyperbaric chambers Do not dive below 10 meters 33 feet of water or enter hyperbaric chambers above 2 0 atmospheres absolute ATA Pressures below 10 meters 33 feet of water or above 2 0 ATA can damage the neurostimulation system Before diving or using a hyperbaric chamber discuss the effects of high pressure with your doctor Skydiving skiing or hiking in the mountains High altitudes should not affect the neurostimulator however you should consider the movements involved in any planned activity and take care to not put undue stress on your implanted neurostimulation system During skydiving the sudden jerking that occurs when the parachute opens can dislodge or fracture the lead requiring additional surgery to repair or replace the lead Unexpected changes in stimulation Electromagnetic interference changes in posture and other activities can cause a perceived increase in stimulation which 37743 2007 09 English Important therapy information 2 Important therapy information 2 o some patients have described as uncomfortable stimulation a jolting or shocking sensation You should reduce your amplitude to the lowest setting and turn OFF your neurostimulator before engaging in activities that could become unsafe for you or others if you received an unexpected jolt or shock eg driving operating power tools Discuss these activities with your doctor Individualizatio
16. do not need to hold the patient programmer over your neurostimulator However you must hold the patient programmer over your neurostimulator when pressing all other keys except the POWER key English 37743 2007 09 Checking batteries Checking the external neurostimulator battery Check the external neurostimulator battery level every day To check the external neurostimulator battery level hold the patient programmer over your neurostimulator and press the SYNC 2 key The THERAPY screen appears displaying the external neurostimulator battery level Figure 4 6 Battery level 65 z amp M A ull 3 50 Caen nee Replace 4 4 Full batteries Figure 4 6 External neurostimulator battery status on the THERAPY screen When the batteries are low replace the batteries as described in the external neurostimulator patient guide 37743 2007 09 English Using your patient programmer 4 o J Using your patient programmer 4 o Screens indicating that the external neurostimulator batteries need immediate replacement are shown in Table 4 4 Table 4 4 External neurostimulator battery Cra replacement screens The external neurostimulator batteries are low and stimulation will not be available soon Replace the external neurostimulator batteries Refer to the manual packaged with the external neurostimulator The external neurostim
17. implant site for 2 to 6 weeks Your doctor may also prescribe physical therapy or medication to help manage your pain Always follow your doctor s instructions Activities Some movements can cause changes in stimulation For example leaning back may cause the lead to move closer to your spinal cord this can increase the sensation of stimulation Other movements may cause the lead to move further away from your spinal cord and decrease the stimulation sensation Sudden changes in stimulation are most common during recovery 37743 2007 09 English Introduction to stimulation 3 c Introduction to stimulation 3 c e Avoid activities where you must bend stretch or twist your body these movements can move your leads which affects your stimulation e Avoid lying on your stomach Avoid reaching over your head e Avoid turning from side to side e Avoid bending forward backward or from side to side e Avoid lifting more than 2 kilograms 5 pounds As you begin to feel better you should be able to perform activities such as e Bathing or showering e Sexual activity e Working at home or at your business e Hobbies or activities such as walking gardening cycling or swimming e Traveling English 37743 2007 09 Remember returning to your daily activities should make you feel better not worse Note As you adjust to life with better pain management you may want to try activities that you cou
18. implanted non rechargeable Implanted rechargeable neurostimulator See Neurostimulator implanted rechargeable Increase key 87 88 98 Increasing a parameter 85 89 Indications 21 Information screens 123 128 Interference See Electromagnetic interference EMI Keys patient programmer 96 98 Laser procedures 160 Leads 44 Lithotripsy 152 Low battery level screen external neurostimulator 128 implanted non rechargeable neurostimulator 129 patient programmer 128 Low battery screen 70 Lower limit 88 Magnetic resonance imaging MRI 153 Magnetoencephalography MEG 164 Magnets therapeutic 164 Mammography 164 Microwave ablation 155 English 37743 2007 09 Navigator key 65 66 96 Neurostimulation system parts 42 Neurostimulator external checking battery level 67 68 description 43 low battery level screen 128 replace batteries warning screen 117 replacing batteries 67 turning ON or OFF 77 when to turn OFF 36 Neurostimulator implanted non rechargeable checking battery level 73 74 description 43 disposing of 143 low battery level screen 129 130 turning ON or OFF 77 when to turn OFF 36 Neurostimulator implanted rechargeable battery charge level warning screen 118 charging the battery 49 50 checking battery level 69 72 description 43 disposing of 143 low battery charge level screen 127 recharge warning screen 118 turning ON or OFF 77 when to turn OFF 36 Neurostimulator OFF key 59 97 Neurostimulator ON key 59 97 N
19. in a 55 square meter 600 square foot Minneapolis garage we have transformed Medtronic into a worldwide company that serves customers in more than 120 countries Each year millions of patients are treated with Medtronic products and therapies We invest almost 500 million each year in research and development working closely with the world s leading physicians and scientists to enhance our current products and therapies and to English 37743 2007 09 develop new ones Although we are a large company individual patients and their needs are still the driving force behind what we do and how we do it Our goal is to improve the quality of your life This booklet which provides information about your neurostimulation system is one small way we try to help Welcome to the Medtronic family We wish you well How to use this manual Use this manual during test stimulation and after receiving an implanted neurostimulator Ask your clinician to explain anything that is unclear e Chapter 1 Introduction describes the patient documents your clinician should have provided to you e Chapter 2 Important therapy information describes when you should and should not use a neurostimulation 37743 2007 09 English ntroduction 1 c Introduction 1 system and the risks benefits warnings precautions and patient activities related to your neurostimulation system Chapter 3 Introduction to stimulati
20. is not possible however the clinician may be able to restore the battery function Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways e Battery function is restored however charging sessions may be more frequent because battery capacity has been reduced English 37743 2007 09 e Battery function is not restored and the neurostimulator must be surgically replaced Battery function is not restored because The neurostimulator battery is permanently damaged The neurostimulator battery has been overdischarged and restored twice before The third time the battery is overdischarged the neurostimulator will reach end of service Surgery is required to replace the neurostimulator If the implanted neurostimulator needs immediate charging you will see one of the screens shown in Table 4 5 37743 2007 09 English Using your patient programmer 4 Using your patient programmer 4 N N Table 4 5 Implanted rechargeable neurostimulator ca battery screens The implanted neurostimulator battery charge level is low and stimulation will not be available soon Charge your implanted neurostimulator battery Refer to the manual packaged with the charging system Press any arrow on the NAVIGATOR key to clear this message from the screen The neurostimulator battery charge level is low and stimulation has stopped Charg
21. muscle spasms reduce joint contractures reduce swelling and pain after surgery and promote wound healing Electrode A metal piece near the tip of the lead Electrodes deliver electrical pulses to the area where your pain signals will be blocked Electromagnetic interference EMI A strong field of energy near electrical or magnetic devices that could prevent the neurostimulator from functioning properly EOS End of service EOS A notification that the neurostimulator has reached scheduled end of service At EOS the neurostimulator no longer delivers the electrical pulses that block pain signals ERI Elective replacement indicator ERI A notification that the neurostimulator is nearing scheduled end of service English 37743 2007 09 Extension A thin wire covered with a protective coating that connects the neurostimulator to a lead External neurostimulator ENS See Neurostimulator Group Combined programs that provide stimulation to one or more pain sites Each group may be defined for a different activity symptom or time of day Group rovv The middle rovv on the THERAPY screen This row includes groups that a patient can change Implantable neurostimulator INS See Neurostimulator Indication The purpose of the neurostimulation system and the medical condition for which it may be implanted Lead A thin wire with protective coating that has metal electrodes on o
22. or OFF particularly in a neurostimulator enabled for magnet use or to reset to the power on reset POR values resulting in loss of stimulation return of underlying symptoms and in the case of POR requiring your health care provider to reprogram your neurostimulator Unexpected changes in stimulation causing a momentary increase in stimulation or intermittent stimulation which some patients have described as a jolting or shocking sensation Although the unexpected change in stimulation 37743 2007 09 English Important therapy information 2 N c Important therapy information 2 N o could feel uncomfortable it does not damage the device or injure a patient directly In rare cases as a result of the unexpected changes in stimulation patients have fallen down and been injured Refer to Table 2 1 on page 27 and Appendix A Electromagnetic interference EMI on page 147 for information on the sources of EMI the effect of EMI on you and your neurostimulation system and instructions on how to reduce the risk from EMI English 37743 2007 09 2 uomeuuojur Adejeui jueuoduu 291 oDed pjouesnoH Asdujoui za ebed soiuoseJn indino ubiH suoneis samod Buipjew s olA p 691 eDed oneuDeuio42e 3 g9 SIS 0J199 3 LG 19 ne204199 3 9v oDed onnedeijeui Awaye g9 oDed seqoJd pue s jup jejueq UOISJOAOI
23. requiring your health care provider to reprogram your neurostimulator e The neurostimulator can move within the implant pocket and align with the MRI field resulting in discomfort or reopening of a recent implant incision In addition the MRI image can be degraded distorted or blocked from view by your implanted neurostimulation system Radiofrequency RF microwave ablation Safety has not been established for radiofrequency RF or microwave ablation in patients with an implanted neurostimulation system Induced electrical 37743 2007 09 English Appendix A Electromagnetic interference Appendix A Electromagnetic interference 156 currents can cause heating especially at the lead electrode site resulting in tissue damage Theft detectors and security devices Use care when approaching theft detector and security devices such as those found in airports libraries and some department stores When approaching these devices do the following 1 Show the security personnel your patient identification card for the neurostimulator and ask for a manual search Security personnel may use a handheld security wand but ask them not to hold the security wand near the neurostimulator any longer than is needed If you must pass through the theft detector or security screening device turn your neurostimulator OFF approach the center of the device and walk through normally English 37743
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25. 004 USA Medtronic Inc Tel 1 763 505 5000 Toll free 1 800 328 0810 Fax 1 763 505 1000 Medtronic Alleviating Pain Restoring Health Extending Life Manufacturer Medtronic Inc 710 Medtronic Parkway Minneapolis MN 55432 5604 USA Internet www medtronic com Tel 1 763 505 5000 Fax 1 763 505 1000 Medtronic E C Authorized Representative Distributed by Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel 31 45 566 8000 Fax 31 45 566 8668 Europe Africa Middle East Headquarters Medtronic International Trading Sarl Route du Molliau 31 Case Postale CH 1131 Tolochenaz Switzerland Internet www medtronic co uk Tel 41 21 802 7000 Fax 41 21 802 7900 Asia Pacific Medtronic International Ltd Suite 1602 16 F Manulife Plaza The Lee Gardens 33 Hysan Avenue Causeway Bay Hong Kong Tel 852 2891 4068 Fax 852 2591 0313 Contacts for specific countries are listed inside this cover 9 66A001 M9284 All Rights Reserved M928466A001 Medtronic Inc 2007 A
26. 07 09 Electromagnetic field devices The following equipment or environments should be avoided Antennas of citizen band CB or ham radios Electric arc welding equipment Electric induction heaters Electric steel furnaces High power amateur transmitters High voltage areas safe if outside the fenced area Linear power amplifiers Magnetic degaussing equipment Magnets and other equipment that generate strong magnetic fields Microwave communication transmitters safe if outside the fenced area Perfusion systems Resistance welders 37743 2007 09 English Appendix A Electromagnetic interference Appendix A Electromagnetic interference 160 Television and radio transmitting towers safe if outside the fenced area If you suspect that equipment is interfering with the neurostimulation system do the following 1 Move away from the equipment or object 2 If possible turn off the equipment or object 3 Then if necessary use the patient programmer to return the neurostimulator to the desired ON or OFF state 4 Inform the equipment owner or operator about the interference If the above actions do not resolve the effects of the interference or you suspect that your therapy is not the same after exposure to EMI contact your doctor Laser procedures The neurostimulator should be turned OFF and the laser should be directed away from the neurostimulation system English 377
27. 3 37743 2007 09 English Using your patient programmer 4 o Using your patient programmer 4 o N Table 4 1 Status row icons Row Icons Description Status 65 Neurostimulator is ON Implanted or external neurostimulator Neurostimulator is OFF Implanted or external neurostimulator Implanted rechargeable neurostimulator battery charge level The rechargeable implanted neurostimulator battery charge level is low The non rechargeable implanted neurostimulator is near the end of service K External neurostimulator Tual battery level Patient programmer battery c level The icons on the Group row indicate the name of the group whether or not the group is active and whether or not your clinician English 37743 2007 09 has programmed Scheduled Therapy for you Table 4 2 Table 4 2 Group row icons Row lcons Description Group M Active L1 Not active e Scheduled Therapy refer to page 78 A B C Group name icons text refer to page 105 2 Walk The icon ortext on your patient programmer screen may differ The group name will be displayed as a single letter an icon or text 37743 2007 09 English Using your patient programmer 4 o Using your patient programmer 4 o AR The icons on the Parameter row indicate the settings for your stimulation and whether or not your clinician has enabled GroupAdjust or TARGETmyStim for yo
28. 43 2007 09 Psychotherapeutic procedures Safety has not been established for psychotherapeutic procedures using equipment that generates electromagnetic interference eg electroconvulsive therapy transcranial magnetic stimulation in patients who have an implanted neurostimulation system Induced electrical currents may cause heating especially at the lead electrode site resulting in tissue damage Radiation therapy High radiation sources such as cobalt 60 or gamma radiation should not be directed at the neurostimulation system If radiation therapy is required near the neurostimulation system lead shielding should be placed over the device to help prevent damage Transcutaneous electrical nerve stimulation TENS TENS electrodes should not be placed so that current passes over any part of the neurostimulation system If you feel that the TENS unit might be interfering with your neurostimulator 37743 2007 09 English Appendix A Electromagnetic interference 161 discontinue using the TENS until you talk with your doctor Notes Household items Most household appliances and equipment that work properly and are properly grounded will not interfere with the neurostimulation system The following equipment is safe if you follow these guidelines Computer disk drives Keep the neurostimulator away from disk drives e Induction range Keep the neurostimulator away from the burners while the burners ar
29. EPZZE Iepojy Dluosjpayy SIlel p 4ejdeuo do gi ees yenueyy sasp Kdeieu uled 1426 EPZZE 1 DOVV uone nuilis 1991 JO suononJjsul pue sjueuodujoo saaye sjeo eui sequoseq OPIND juajeg uonejnuills 1821 4oje nuisounaN EU49 X3 ZZOLE I POW ouonpeyy qSNI 4501 1uejdugj SN3 o qeoD1euoaJ uoN ajqeabieyooy sal juejduui pue 1s 10 sepin jueneg ALL uogonpoJlu English 37743 2007 09 16 uononpoJu Jojejnuinsouneu ejqejue dui q Jojejnuunsouneu euJ8lX3 e 40120p ino4 pue j0jejnuunsounau ino noA 1noge uoneuuojul sepi o4g PIED UOIJEDYIUAP 4218 4SNI 1uejdug 4SNI 1uejdug SN3 o qeaDJeuooJ UON ajqeabieyooy 1591 luowunood penumnuoo 1uejduui pue uone nuumns 1591 10 s pin juened LL QEL 7 37743 2007 09 English Introduction 1 Patient identification card VVhen you leave the hospital your doctor vvill give you a patient identification card This card supplies information about you your implanted device and your doctor Your identification card may allovv you to bypass security devices Carry this card with you at all times f you move change doctors or lose your card contact Medtronic for a replacement card Refer to the Medtronic contacts at the end of this manual A temporary identification card vvill be provided a
30. Group name icons text Icon display dec Definition i Sit Group for use when you are sitting Stand Group for use when you are standing Lie Group for use when you are lying x VValk Group for use when you are vvalking 221 Sleep Group for use when 2 Write you are sleeping Group for use when you are writing Group for use during the day C Night Group for use during the night d Back Group for back pain x L Leg Group for left leg pain 37743 2007 09 English Using your patient programmer 4 107 Using your patient programmer 4 108 Table 4 15 Group name icons text continued Text Icon display display Definition R Leg Group for right leg pain x Legs Group for leg pain X L Arm Group for left arm pain X R Arm Group for right arm pain Xx Arms Group for arm pain y Hand Group for hand pain Foot Group for foot pain The text display listed in this column will be displayed on the patient programmer exactly as shown in this column ie the text display will not be translated from English into local languages Replacing the patient programmer batteries Always keep two new AAA alkaline batteries available for replacement New batteries English 37743 2007 09 provide about two months use depending upon how often the patient programmer is used Caution If the device will not be used for several weeks remove the
31. Group row on the THERAPY screen 3 Press the left or right gt arrows on the NAVIGATOR key to move the selection box to the new group Figure 4 12 N Caution Select the group that your clinician has recommended for the current activity or posture Use of another group may result in uncomfortable or unexpected stimulation jolting or shocking sensation when stimulation is turned ON 37743 2007 09 English Using your patient programmer 4 co Using your patient programmer 4 4 Go um 58 l all 4 1 Figure 4 12 Moving to a new group 4 Hold the patient programmer over your neurostimulator and press the SYNC key to send the change to your neurostimulator Figure 4 13 5 Verify that the new group is active M on the THERAPY screen Figure 4 13 Figure 4 13 Making a group active English 37743 2007 09 Increasing or decreasing a parameter amplitude pulse width or rate Notes e To increase a parameter the neurostimulator must be ON To decrease a parameter the neurostimulator may be ON or OFF 1 Hold the patient programmer over your neurostimulator with the screen facing outward and press the NEUROSTIMULATOR ON NEUROSTIMULATOR OFF or SYNC key The THERAPY screen appears N Caution To prevent possible uncomfortable or unexpected stimulation jolting or shocking sensation when stimulation is turned ON decrease all amplitudes to the lo
32. J8Ss pauisep si uonej nuuns JI uull S14 1e peddois 01 pe npeuos s uomne nuuns pue Adel u pejnpeuos seu ueniu INO NO 40165Inulsosn u ano4 uan o JOWWeIHOjd q ned noA esf 34O SI uogejnuins suon e pue s sneo NO 8q pinous uonernuls yuy NOA yng uonejnuuns JOU op NOA uomne nuuns ON sul lqold penuguoo suiejqoud Gunoouse qnoJ ps 4 G Bunoousejqnoi English 37743 2007 09 134 Bunoousejqnoi 310 pinoys s ulur Solsd 1uened ay AIL p yolu Jo peddiuo SI BSED y H U A jewou eje1edo ns pue eoeyns e o doup oys e o peuBisep s 1uened eu e ge1 10 euiqeo e jo sje juaned uno 1euruej4504d 1uened peddoug S L nNEQ 1ourueabo4d 1uoned ay jje1sureJ pue Ajuejod As neq ay SpJeMyXoeq ul ase s L neq 1eujuej6o4d 1uened eu S L NEQ 1uoned eui eoejdou peiejdep ale s n yeq juemed ay 5 pue s sneo hoy e sseJd no u uM xXuelq SI ua9Jos Ke dsip eAisuodsejun SI 1uoned sul lqold penuguoo suiejqoud Gunoouse qnoJ tS 4 135 37743 2007 09 English SINOY pz 40 9o1n1e49duujo woo 16 Alp 11e 0 3uounJjedujoo As neq 9u1 AMO HIE UdU S L N EQ eu uea Ul peueduiep Joe
33. LL 29 37743 2007 09 English Important therapy information 2 Case damage If the neurostimulator case is ruptured or pierced due to outside forces severe burns could result from exposure to the battery chemicals Neurostimulator interaction with cardiac implantable devices When a neurostimulator and an implanted cardiac device eg pacemaker defibrillator are required the doctors involved with both devices neurologist neurosurgeon cardiologist cardiac surgeon should discuss the possible interaction between the devices before surgery To minimize or prevent device damage or interactions your doctors should place the devices on the opposite side of the body from one another e Defibrillation therapy from the implanted defibrillator can damage the neurostimulator e The electrical pulses from the neurostimulation system could affect the sensing operation of the cardiac device and result in inappropriate responses from the cardiac device Your doctor English 37743 2007 09 should reprogram your neurostimulator to a bipolar configuration and a minimum rate of 60 Hz The cardiac device should be programmed to bipolar sensing Precautions System and therapy Clinician programmer interaction with a cochlear implant If you have a cochlear implant the external portion of the cochlear system should be kept as far away as possible from the clinician programmer or the cochlear implant sh
34. MRI guidelines for head only MRI scans Contact information is found on the last page of this manual The known potential risks are as follows Induced electrical currents during an MRI using a radiofrequency RF transmit body coil can cause heating of the 37743 2007 09 English Appendix A Electromagnetic interference neurostimulation system especially at the lead electrode site which can cause tissue damage and can result in severe injury or death Induced electrical currents can also stimulate or shock you Note This warning applies even if only a lead or an extension is implanted in your bogy Factors that increase the risks of heating and injury include but are not limited to the following High MRI Specific Absorption Rate SAR Radio Frequency RF power levels Lower impedance leads or extensions Medtronic product names or model numbers designated with a 7 an LZ or Low Impedance MRI RF transmit coil that is near or extends over the implanted lead Implanted leads with small surface area electrodes Appendix A Electromagnetic interference 154 English 37743 2007 09 Short distances between lead electrodes and tissue that is sensitive to heat e An MRI can permanently damage the neurostimulator requiring it be removed or replaced e An MRI can affect neurostimulator operation The MRI can also reset the neurostimulator to power on reset values
35. OSTIMULATOR ON or NEUROSTIMULATOR OFF key Figure 4 9 2 Verify that the appropriate ON or OFF icon is displayed on the THERAPY screen Figure 4 9 Figure 4 9 Turning your neurostimulator ON or OFF N Caution To prevent possible uncomfortable or unexpected stimulation jolting or shocking sensation when stimulation is turned ON decrease all 37743 2007 09 English Using your patient programmer 4 N Using your patient programmer 4 N co amplitudes to the lovvest setting before adiusting the pulse vvidth or rate and after turning OFF the neurostimulator 3 If you have turned the neurostimulator OFF decrease the program amplitudes to the lowest setting For instructions see ncreasing or decreasing a parameter amplitude pulse vvidth or rate on page 85 Note VVhen you turn your neurostimulator ON or OFF the patient programmer and neurostimulator are synchronized Scheduled Therapy Scheduled Therapy allows your clinician to program therapy for a specific time of day If your clinician programmed Scheduled Therapy the SCHEDULED THERAPY Qx icon appears in the Group row English 37743 2007 09 An example of Scheduled Therapy is provided in Figure 4 10 The screens and timetable display the following Group B is active most of the day and stimulation is ON Stimulation is OFF during sleep Stimulation is stopped Figure 4 10 Example of Scheduled Therapy Note Y
36. a to 106 kPa atmospheric 20 7 in Hg to 31 3 in Hg pressure Size 9 4 cm x 5 6 cm x 2 8 cm approximate 8 7 in x 2 2 in x 1 1 in Weight including 111 g 3 9 oz batteries approximate Battery life 2 months average for alkaline batteries Mode of operation Continuous Maintenance 6 144 English 37743 2007 09 Table 6 2 Implanted neurostimulation system specifications Description Specifications Typical materials in contact with human tissue Neurostimulator Titanium Polyurethane Silicone rubber Silicone medical adhesive Polysulfone Lead Polyurethane Platinum iridium Extension Polyurethane a For a complete list of materials in contact vvith human tissue contact your clinician b Polysulfone is contained in the rechargeable neurostimulators only Maintenance 6 37743 2007 09 English 145 Maintenance 6 146 English 37743 2007 09 Electromagnetic interference EMI 7 Appendix A Appendix A Electromagnetic interference 148 Please review Electromagnetic interference EMI on page 24 and Table 2 1 on page 27 for additional information Before any medical procedure is begun always inform any health care personnel that you have an implanted neurostimulation system The potential for the following effects results from an interaction of the neurostimulation system and equipment even when both are working properly Contraindication Diathermy Inf
37. able antenna optional Carrying case Figure 3 4 External parts of a typical neurostimulation system Neurostimulator The neurostimulator is the power source battery for your neurostimulation system It contains electronics that generate the electrical pulses During test stimulation an external neurostimulator is used to determine 37743 2007 09 English Introduction to stimulation 3 AR Introduction to stimulation 3 A A whether an implanted neurostimulator is the right choice for you The implanted neurostimulator may include a rechargeable battery e The implanted Model 37711 Restore Model 37712 RestoreULTRA and Model 37713 RestoreADVANCED neurostimulators contain rechargeable batteries e The implanted Model 37701 RestorePRIME and Model 37702 PrimeADVANCED neurostimulators contain non rechargeable batteries Lead s A lead is a set of thin wires covered with a protective coating A lead has small metal electrodes near the tip The electrodes transmit electrical pulses to the area where your pain signals are blocked Extension s An extension is a set of thin wires covered with a protective coating that connects the neurostimulator to a lead Patient programmer A patient programmer is a hand held device that you English 37743 2007 09 use to select and adjust your stimulation A detachable antenna is also available if you have difficulty reaching the neurostimulator im
38. ammer After synchronizing the THERAPY screen appears 37743 2007 09 English Using your patient programmer 4 Cc Using your patient programmer 4 o e Understanding the THERAPY screen The THERAPY screen appears on the patient programmer display after the patient programmer and neurostimulator have been synchronized refer to Synchronizing on page 58 The information that appears on the THERAPY screen may be different for each patient The information depends on which neurostimulator you have and how your clinician has programmed your neurostimulator Note Figures in this chapter present information common to rechargeable and non rechargeable neurostimulators Some figures may display battery level icons that are unique to rechargeable neurostimulators English 37743 2007 09 Information on the THERAPY screen is arranged in three rows the Status row the Group row and the Parameter row The information on each row is represented by icons Figure 4 3 BATTERY LEVEL icon 6 Go amp Status row A Ps MA Group row M A AM 3 50 61 Parameter row All 3 501e Rechargeable Non rechargeable Figure 4 3 THERAPY screen Icons on the Status row indicate your neurostimulator status and the battery level of your patient programmer Table 4 1 on page 62 If you have a rechargeable neurostimulator the Status row also displays the BATTERY LEVEL icon for the rechargeable neurostimulator Figure 4
39. ange active electrode positions as needed 37743 2007 09 English Using your patient programmer 4 c Using your patient programmer 4 o 5 Once the desired levels are displayed press the SYNC key Note The patient programmer changes the electrode position then the amplitude slowly increases until it reaches the programmed value Pressing the INCREASE or DECREASE C key will stop the amplitude increase before it reaches the programmed value 6 Press the left arrow on the NAVIGATOR key to return to the THERAPY screen Summary of keys DECREASE NEUROSTIMULATOR ON NEUROSTIMULATOR OFF Figure 4 20 Patient programmer keys English 37743 2007 09 Key ON OFF Table 4 10 Summary of keys Function Turns the neurostimulator ON or OFF The patient programmer must be held over the neurostimulator while pressing the NEUROSTIMULATOR ON or OFF key Pressing either of these keys also automatically synchronizes the neurostimulator and patient programmer and displays the THERAPY screen Sync Synchronizes the neurostimulator and patient programmer Activates a selected group The patient programmer must be held over the neurostimulator while pressing the SYNC key 37743 2007 09 English Using your patient programmer 4 SJ Using your patient programmer 4 Table 4 10 Summary of keys continued Key C Decrease Increase Functio
40. ar changes around the electrode s changes in the position of the electrode s loose electrical connections or lead or extension 37743 2007 09 English Important therapy information 2 N Important therapy information 2 N AR fractures It is also possible that the implanted materials could cause an allergic or immune system response Your neurostimulation system might unexpectedly cease to function due to battery depletion or other causes These events which can include electrical shorts or open circuits conductor wire fractures and insulation breaches cannot be predicted Warnings Electromagnetic interference EMI Electromagnetic interference is a field of energy generated by equipment found in the home work medical or public environments that is strong enough to interfere with neurostimulator function Neurostimulators include features that provide protection from EMI Most electrical devices and magnets encountered in a normal day are unlikely to affect the operation of a neurostimulator However strong sources of EMI can result in the following English 37743 2007 09 e Serious patient injury or death resulting from heating of the implanted components of the neurostimulation system and damage to surrounding tissue System damage resulting in a loss of or change in symptom control and requiring additional surgery Operational changes to the neurostimulator that can cause it to turn ON
41. batteries from the device A battery left in the device may corrode causing damage to the electronic components 1 Open the battery compartment cover Figure 4 24 Figure 4 24 Opening the battery cover 2 Remove the depleted batteries 37743 2007 09 English Using your patient programmer 4 Using your patient programmer 4 110 3 Insert the new batteries as shown on the battery compartment label 4 Close the battery compartment cover 5 Dispose of old batteries according to local requirements Using the carrying case and labeling the patient programmer The carrying case has a pouch to hold the patient programmer and the quick reference guide Figure 4 25 The case also has a loop on the back that attaches to a belt Go Figure 4 25 Insert the patient programmer into the case English 37743 2007 09 Place an identification label on the back of your patient programmer in case the patient programmer is lost Figure 4 26 D Figure 4 26 Place the adhesive label on the back of the patient programmer Optional detachable antenna The detachable antenna is available if you have difficulty reaching the neurostimulator It is also useful for viewing the patient programmer screen while you are adjusting stimulation Connecting the antenna 1 Place the antenna over your neurostimulator Figure 4 27 Using your patient programmer 4 37743 2007 09 English 111
42. e the neurostimulator battery now Refer to the manual packaged with the charging system English 37743 2007 09 Checking the implanted non rechargeable neurostimulator battery Models 37701 and 37702 To check the implanted non rechargeable neurostimulator battery status hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key The THERAPY screen appears When the battery in a non rechargeable neurostimulator is nearing depletion the neurostimulator must be replaced to continue receiving stimulation therapy Surgery is required to replace the non rechargeable neurostimulator Screens indicating that the non rechargeable neurostimulator battery is nearing depletion are shown in Table 4 6 37743 2007 09 English Using your patient programmer 4 Using your patient programmer 4 AZ Table 4 6 Implanted non rechargeable neurostimulator battery screens j gt 8 The implanted non rechargeable neurostimulator battery is nearing depletion and stimulation will not be available soon Call your clinician to schedule a visit You may clear this screen and return to the THERAPY screen by pressing any arrow on the NAVIGATOR key This screen reappears daily After clearing this screen a low battery level icon appears on the Status row of the THERAPY screen The implanted non rechargeable neurostimulator battery is dep
43. e turned on e Freezer refrigerator or storm doors Do not lean against the magnetic strip that holds the door closed e Power tools Keep the motor away from the neurostimulator lead and extension Appendix A Electromagnetic interference 162 English 37743 2007 09 Radio frequency sources Keep AM FM radios and cellular cordless and conventional telephones at least 10 cm 4 in away from the implanted neurostimulator Sewing machines or salon hair dryers Keep the neurostimulator away from the motors Stereo speakers and radios for the home or car Do not lift or carry them close to or touching the part of your body where the neurostimulator is located Other medical procedures EMI from the following medical procedures is unlikely to affect your neurostimulation system Computerized axial tomography CT or CAT scans Diagnostic ultrasound eg carotid scan doppler studies Note To minimize potential image distortion the neurostimulator should be turned OFF and the transducer kept 37743 2007 09 English Appendix A Electromagnetic interference o Appendix A Electromagnetic interference 164 15 cm 6 in away from the neurostimulation system e Diagnostic X rays or fluoroscopy Note Tight pressure in the area of your neurostimulator such as used during mammography can damage the neurostimulator or disconnect components of your neurostimulation system This will require surge
44. ey to return to the THERAPY screen Press the SYNC key to send the change to your neurostimulator To verify the time change repeat steps 2 and 3 on page 100 to return to the TIME PREFERENCE screen English 37743 2007 09 Table 4 12 Changing preferences continued Time and number format G 1 Press the left 4 or right p gt 3 50 P arrow on the NAVIGATOR Key to 10 00pm move the selection box to a 12 hour clock and numbers with decimals or with a 24 hour clock and numbers with commas 2 Go to step 6 page 103 Group name display See page 105 Return to clinician settings See page 104 6 When the change is displayed on the screen move the selection box to the Status top row Note The preference change is sent to the neurostimulator at the next synchronization 37743 2007 09 English Using your patient programmer 4 7 Press the left 4 or right gt arrow on the NAVIGATOR key to move to another preference or return to the THERAPY screen Changing to clinician settings You can change the stimulation settings for the active group back to the original settings programmed by your clinician Table 4 13 Using your patient programmer 4 104 English 37743 2007 09 Table 4 13 Changing to clinician settings Clinician settings preference 1 Verify that the desired group is active M 2 Complete steps 1 4 beginning on page 100 Note Clinician settin
45. f your patient programmer and accessories Cleaning and care Follow these guidelines to ensure that the patient programmer and accessories function properly A Caution If the device will not be used for several weeks remove the batteries from the device A battery left in the device may corrode causing damage to the electronic components Keep the device out of the reach of children and pets Use the device only as explained to you by your clinician or as discussed in this manual Maintenance 6 140 English 37743 2007 09 Follow all warnings and precautions in chapter 2 Important therapy information and chapter 7 Appendix A Electromagnetic interference EMI Handle the device with care Do not drop strike or step on the device Do not dismantle or tamper with the device Clean the outside of the device with a damp cloth when necessary Mild household cleaners will not damage the device or labels The device is not waterproof Do not allow moisture to get inside the device Keep fresh batteries available Replace low or depleted batteries 37743 2007 09 English Maintenance 6 A oh Maintenance 6 142 Safety and technical checks Periodic safety and technical checks or periodic maintenance of the patient programmer are not required The patient programmer contains no user serviceable parts If repair or service is needed contact your clinician or a Medtronic sales office
46. ful area Increase amplitude s or pulse width s or change to a different group The pulses tapping sensations feel too slow Increase rate The pulses tapping sensations feel too fast Decrease rate 37743 2007 09 English Using your patient programmer 4 E Using your patient programmer 4 co N Table 4 8 Stimulation adjustment guidelines continued Situation You have unexpected changes in stimulation Action 1 Turn OFF the neurostimulator 2 Decrease amplitude s turn ON the neurostimulator adjust parameters and slowly increase amplitude s to the desired level or Change to a different group and turn ON the neurostimulator You have tried adjusting stimulation but are unable to find an effective setting Contact your clinician You will be passing through a theft detector or security device You will be using potentially dangerous equipment You will be having a medical procedure Before engaging in these activities consult Appendix A Electromagnetic Interference EMI for details English 37743 2007 09 Changing a group 1 Hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key The THERAPY screen appears If needed press the up arrow on the NAVIGATOR key to move the selection box to the Group row Figure 4 11 7 da am ail 3 50 Figure 4 11
47. gs will be applied to the group that is indicated on the CLINICIAN SETTINGS PREFERENCE screen 3 Press the SYNC key to send the change to your neurostimulator and return to the THERAPY screen Changing group names Models 37702 37712 and 37713 If your implanted neurostimulator is a Model 37702 PrimeADVANCED a Model 37712 RestoreULTRA or a Model 37713 RestoreADVANCED and your clinician enabled the Group name icons text function you can change the group name displayed on the patient programmer screen Table 4 14 You can change the group name displayed 37743 2007 09 English Using your patient programmer 4 co Using your patient programmer 4 106 on the screen to a letter eg A an icon eg or text eg Walk Table 4 14 Changing Group name preferences Group name preferences 1 7 1 4 beginning on page 1 2 Press the or right arrow on the NAVIGATOR key to move the selection box to one of the following Icons amp amp z Letters or Text Abc 3 Go to step 6 page 103 Your clinician may enable the Group Name icons text function to specify the groups to use for specific areas of coverage activity and time of use Table 4 15 lists the Group name preferences that may be available Note Use the definitions listed in Table 4 15 to understand the icon or text displayed on your patient programmer English 37743 2007 09 Table 4 15
48. hable antenna check that the antenna is connected properly reposition the antenna and try communication again You tried increasing a parameter value with the neurostimulator OFF Turn your neurostimulator ON and try communication again 37743 2007 09 English Troubleshooting 5 N Troubleshooting 5 126 Table 5 3 Information Screen Upper limit amplitude shown screens continued Description and action You tried increasing a parameter amplitude pulse width or rate above the highest value allowed Upper limit 00R amplitude shown You tried increasing a parameter amplitude pulse width or rate above what your neurostimulator can deliver Decrease another parameter before increasing this parameter Recharge the rechargeable neurostimulator battery if applicable Replace the external neurostimulator batteries if applicable English 37743 2007 09 Table 5 3 Information screens continued Screen Lower limit amplitude shown Description and action You tried decreasing a parameter amplitude pulse width or rate below the lowest value allowed The cable to the external neurostimulator is loose or disconnected Connect the cable to the external neurostimulator Turn the patient programmer OFF then ON again Rechargeable implanted neurostimulator battery charge level is low um The implanted neurostimula
49. ion screens The information screens show the programming status and the battery level for your patient programmer The information screen also indicates the battery level of a rechargeable neurostimulator If the audio is ON three tones alert you to the message Table 5 3 describes information screens and instructions on how to proceed see blue text Note Press any arrow on the NAVIGATOR key to clear an information screen 37743 2007 09 English Troubleshooting 5 N Table 5 3 Information screens Screen Description and action Poor The patient programmer communication attempted to communicate with the implanted neurostimulator but communication was unsuccessful Reposition the patient programmer over the implanted neurostimulator with the screen facing outward and try communication again If using the detachable antenna check that the antenna is connected properly reposition the antenna and try communication again Troubleshooting 5 124 English 37743 2007 09 Table 5 3 Information screens continued Screen Poor communication Press NEUROSTIMULATOR ON key Description and action The patient programmer attempted to communicate with the external neurostimulator but communication was unsuccessful Reposition the patient programmer over the external neurostimulator with the patient programmer screen facing outward and try communication again If using the detac
50. lation the first consideration is your survival External defibrillation or cardioversion can damage a neurostimulation system and cause induced electrical currents through the lead and extension These induced electrical currents could injure you The current flowing through the neurostimulation system should be minimized as follows e Paddles should be positioned as far from the neurostimulator as possible e Paddles should be positioned perpendicular to the neurostimulation system English 37743 2007 09 e The lowest clinically appropriate energy output watt seconds should be used After external defibrillation your doctor should confirm that the neurostimulation System is working as intended Electrocautery If electrocautery tools are used near an implanted device or contacts a device the following effects can occur e The insulation on the lead or extension can be damaged causing the lead or extension to fail or causing induced currents that can damage tissue or stimulate or shock you e The neurostimulator can be damaged stimulation can be temporarily decreased or increased or the neurostimulator can be turned OFF because the neurostimulator was reset to power on reset values requiring your health care provider to reprogram your neurostimulator When electrocautery is necessary these precautions must be followed 37743 2007 09 English Appendix A Electromagnetic interference 151 Appendix A
51. ld not perform before your surgery Discuss your activity level with your doctor When to call your clinician Contact your clinician if any of the following events occur e You have pain redness or swelling at the incision s later than 6 weeks after surgery You feel discomfort or pain during stimulation Turn your neurostimulator OFF and call your doctor e Your system is not working properly You cannot turn the neurostimulator ON or OFF e You cannot adjust stimulation using your patient programmer 37743 2007 09 English Introduction to stimulation 3 Introduction to stimulation 3 4 Care schedule Your clinician will schedule follow up visits to make sure you are receiving the most appropriate therapy English 37743 2007 09 4 Using your patient programmer Using your patient programmer 4 c o How the patient programmer works The patient programmer communicates with your neurostimulator by sending signals to and receiving signals from the neurostimulator To send and receive the signals the internal antenna of the patient programmer must be placed over the neurostimulator Figure 4 1 Notes e The internal antenna is on the back of the patient programmer The patient programmer screen must face outward An optional detachable antenna is available for patients who have difficulty reaching their neurostimulator refer to page 111 Engli
52. leted and stimulation is not available Call your doctor English 37743 2007 09 Checking the patient programmer batteries To check the patient programmer battery level hold the patient programmer over your neurostimulator and press the SYNC 2 key The THERAPY screen appears displaying the patient programmer battery level Figure 4 8 Battery level 05 m Go MA ul 3 50 Co i an i d Replace 4 Full batteries Figure 4 8 Patient programmer battery level on the THERAPY screen If the patient programmer batteries need immediate replacement you will see one of the screens shown in Table 4 7 37743 2007 09 English Using your patient programmer 4 N Using your patient programmer 4 o Table 4 7 Patient programmer battery m replacement screens The patient programmer batteries are low You can finish programming Press any arrovv on the NAVIGATOR key to clear the screen then continue programming Replace the patient programmer batteries before the batteries become depleted refer to page 108 The patient programmer batteries are depleted Programming is not possible Replace the patient programmer batteries now refer to page 108 English 37743 2007 09 Turning your neurostimulator ON or OFF 1 Hold the patient programmer over your neurostimulator with the patient programmer screen facing outward and press the NEUR
53. m Jomo e YUM 1euruej804d JUEHed oju p ddolp sem 1 Asp u uq y Wo juaned y 10 sawWesBold 1uened ay Aoul l 1uened eui ouo p lilds eoi ep eui eDeuiep ued Je e pue SEN pin J Jeurure1b604d JOOJdJ9 M 10U S 1uered eu 1uened y uo pini i Suonoe pue s sneo sul lqolci penuguoo suiejqoud Gunoouse qnoJ tS 4 G Bunoousejqnoi English 37743 2007 09 136 User assistance The patient programmer has been designed and tested to provide trouble free service If repair or service is needed contact your clinician or a Medtronic sales office Refer to the Medtronic contacts at the end of this manual The serial number is located in the battery compartment This number identifies each patient programmer If you contact Medtronic about your patient programmer refer to the serial number If your patient programmer stops working First try the steps in Table 5 4 on page 132 Otherwise contact your clinician If you lose your patient programmer Contact your clinician to order a new patient programmer To register the patient programmer for service covered by the warranty complete and mail the warranty registration 37743 2007 09 English Troubleshooting 5 J Troubleshooting 5 138 English 37743 2007 09 This section describes how to care for and dispose o
54. n Decreases or increases a parameter The patient programmer must be held over the neurostimulator while pressing the INCREASE Or DECREASE key Pressing and holding the INCREASE or DECREASE x key changes the parameter every half second To increase a parameter the neurostimulator must be turned ON Seul Navigator Moves the selection box on the THERAPY screen The OPTIONS 4 icon at the end of a row on the THERAPY screen indicates that the row continues Q Power Backlight Turns the patient programmer power ON and OFF Pressing and holding this key also turns the backlight oN and orr The backlight provides more light to the display English 37743 2007 09 Preferences Changing the audio contrast time time number format Patient programmer preferences are accessed from the Status row of the THERAPY screen Table 4 11 lists the preference icons Table 4 11 Preference icons Icons Preference q Audio O Contrast Time D Time and number format Group name display A A see page 105 e Return to clinician settings 37743 2007 09 English Using your patient programmer 4 1 Hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key The THERAPY screen appears 2 Press the up A arrow on the NAVIGATOR key to move the selection box to the Status row Figure 4 21 Stat
55. n of treatment Patient management Best results are achieved when you are fully informed about the therapy risks and benefits surgical procedure follow up requirements and self care responsibilities Maximum benefits from the neurostimulation system require long term postsurgical management English 37743 2007 09 Patient selection The neurostimulation system should not be implanted if e your symptoms are not of physiological origin e you are not an appropriate candidate for surgery e you cannot properly operate the system you do not receive satisfactory results from test stimulation Use in specific populations The safety and effectiveness of this therapy has not been established for the following e Pregnancy unborn fetus or delivery e Pediatric use patients under the age of 18 37743 2007 09 English Important therapy information 2 J z uomeuuojur dejeui jueuodu English 37743 2007 09 38 Introduction to stimulation 3 A How stimulation Works Nerve signals from all over your body travel to your spinal cord and then to your brain Your brain translates the signals into sensations such LU J as pain C 4 Stimulation delivers electrical pulses to the area where your pain signals will be blocked as they move to the brain Figure 3 1 Brain translates signal as pain Brain senses pain and tingling Neurostimulator pulses sent to brain
56. ne end and a connector on the other Glossary 37743 2007 09 English 167 Glossary 168 Neurostimulation system Components that deliver electrical pulses to block pain signals as they move to the brain Neurostimulator The power source of a neurostimulation system It contains the battery and electronics that control the stimulation you feel An external neurostimulator is carried outside the body During test stimulation it is used to determine whether or not stimulation is effective An implanted neurostimulator is placed inside the body If stimulation is effective during test stimulation the neurostimulator is implanted Overdischarge The neurostimulator battery continues to lose charge even after you see a low battery L screen Eventually the battery loses enough charge to permanently affect the neurostimulator If this occurs the battery is overdischarged English 37743 2007 09 Parameter One of three stimulation settings that adjust the electrical pulse amplitude pulse width and rate Parameter row The bottom row on the THERAPY Screen Icons indicate the parameters that a patient can adjust Patient programmer A hand held device that allows you to turn your neurostimulator ON and OFF It is also used to adjust some stimulation settings Program Stimulation directed to a specific pain site Precaution See Caution Pulse width The length or duration of
57. on describes the therapy neurostimulation system components and recovery and care information Chapter 4 Using your patient programmer describes the patient programmer and how to perform specific tasks Chapter 5 Troubleshooting describes patient programmer warning and information screens how to solve possible problems and who to contact if your device is lost or broken Chapter 6 Maintenance describes how to care for your patient programmer and system specifications Appendix A provides more information about electromagnetic interference A glossary is included at the end of this manual English 37743 2007 09 Patient guides Table 1 1 on page 16 describes the documents you should receive during test stimulation and after a neurostimulator is implanted Note If your implantable neurostimulator INS has a rechargeable battery you should receive documents for the neurostimulator charging system 37743 2007 09 English Introduction 1 9961 uiei1s s Buifueuo UOWWOD JO suornonujsul Sopi oJd APIND e2uaJ9JoH xoinc uejs4S BuiBueu 196186429H 19226 JGpo y Diuospayy 40je nuunsouneu pejuejduui ue UHA 1I esn O Mou pue uiejs s Buey eui s qu s q enuey s s 5 BuiBueu 196186429H 19226 I POW 29Iuo4poejy SYSE juened uouiuoo JO suononujsui sepi oJg APINH 2 YANO juaned
58. on appears on the Status row of the THERAPY screen POR The implanted neurostimulator has been reset Stimulation is not available Call your clinician You may clear this screen and return to the THERAPY screen by pressing any arrow on the NAVIGATOR key Troubleshooting 5 37743 2007 09 English 129 Table 5 3 Information screens continued Screen Description and action OOR The neurostimulator is unable to deliver the programmed settings Call your clinician You may clear this screen and return to the THERAPY screen by pressing any arrow on the NAVIGATOR key Troubleshooting 5 130 English 37743 2007 09 Possible problems and solutions Table 5 4 will help you solve problems or identify when to call your clinician Problems are described in the left column bold black text The right column lists possible causes of the problem plain text and how to correct the problem bold blue text Note If a problem is not solved after several attempts or if a problem is not described here contact your clinician 37743 2007 09 English Troubleshooting 5 y y ured pIAO d 81 sanjeA O 9je1 pue s nd apnyjdwe v 1sn pe 10 inisod 10 1uaJ1no ANOA 10 ueroluio ano4 Aq p pu wwo 1 SI 1841 ouo zou s dnoJ6 oAnoe eui y ay 5ucu dnoi6 oAnoe ay ul weiHoid uoeo 104 ay
59. ontents Contents 00 Preferences Changing the audio contrast time time number format 99 Changing to clinician settings 104 Changing group names Models 37702 37712 and 37713 105 Replacing the patient programmer batteries 108 Using the carrying case and labeling the patient programmer 110 Optional detachable antenna 111 Connecting the antenna 111 Using the antenna 113 Troubleshooting 115 Patient programmer screens 116 Warning screens 116 Communication screens 122 Information screens 123 Possible problems and solutions 131 User assistance 137 Maintenance 139 Cleaning and care 140 Safety and technical checks 142 English 37743 2007 09 Battery and programmer disposal Neurostimulator disposal 143 Declaration of conformity 143 Specifications 144 Appendix A Electromagnetic interference EMI 147 Contraindication 148 Warnings 150 Precautions 158 Notes 162 Glossary 165 Index 173 37743 2007 09 English 142 Contents Contents 10 English 37743 2007 09 q s nz M m ce ih Introduction 1 N to patients Medtronic was founded in 1949 by Earl Bakken a graduate student in electrical engineering and his brother in law Palmer J Hermundslie Today Medtronic is the world leader in medical technology pioneering therapies that restore health extend life and alleviate pain A company dedicated v From its modest beginnings
60. orm anyone treating you that you CANNOT have any shortwave diathermy microwave diathermy or therapeutic ultrasound diathermy all now referred to as diathermy anywhere on your body because you have an implanted neurostimulation system Energy from English 37743 2007 09 diathermy can be transferred through your implanted system can cause tissue damage and can result in severe injury or death Diathermy can also damage parts of your neurostimulation system This can result in loss of therapy from your neurostimulation System and can require additional surgery to remove or replace parts of your implanted system Personal injury or device damage can occur during diathermy treatment when e the neurostimulation system is turned ON or OFF e diathermy is used anywhere on your body not just where your neurostimulation system is located e diathermy is used to deliver heat or no heat e any component of your neurostimulation system lead extension neurostimulator remains in your body 37743 2007 09 English Appendix A Electromagnetic interference Appendix A Electromagnetic interference 150 Warnings EMI from the following medical procedures or equipment can damage the device interfere with device operation or cause you harm If these procedures or equipment are required the guidelines below must be followed Defibrillation cardioversion When you are in ventricular or atrial fibril
61. ou can still change groups or turn your neurostimulator ON or OFF when Scheduled Therapy is programmed Adjusting stimulation settings There is often more than one way to change stimulation settings These instructions describe the most common ways 37743 2007 09 English Using your patient programmer 4 Using your patient programmer 4 e Notes e Ask your clinician to print a report with your programmed settings e When a stimulation setting is changed you will see the change on the THERAPY screen e f audio is ON you will hear one tone that means the change was effective Three rapid tones mean there was a problem communicating with your neurostimulator and the change may not have occurred To receive the most effective therapy some days you may need to adjust your stimulation several times other days you may not need to adjust it at all Your clinician will provide complete guidelines about when you may want to adjust your stimulation Table 4 8 provides general guidelines for adjusting your stimulation English 37743 2007 09 Table 4 8 Stimulation adjustment guidelines Situation Stimulation is too strong Action Decrease amplitude s or pulse width s Stimulation is not strong enough Increase amplitude s or pulse width s Stimulation covers too much area Decrease amplitude s or pulse width s or change to a different group Stimulation does not cover pain
62. ould be turned OFF during programming to prevent unintended audible clicks Clinician programmer interaction with other active implanted devices If you have a neurostimulator and another active implanted device the radio frequency signal used to program either device can reset or reprogram the other device or the magnet in a cardiac programmer can activate magnetically controlled functions in the 37743 2007 09 English Important therapy information 2 ex Important therapy information 2 N neurostimulator To verify that inadvertent programming did not occur clinicians familiar with each device should check the programmed settings before you are sent home from the hospital and after either device is programmed or as soon as possible after these times Contact your doctor immediately if you notice symptoms that could be related to either device or to the medical condition treated by that device Component compatibility For proper therapy use only Medtronic Neurological components that are prescribed by your physician Patient control devices Do not place patient control devices eg patient programmer over another device eg pacemaker defibrillator another neurostimulator The patient control device could accidently change the operation of another device English 37743 2007 09 Patient device handling To avoid damaging the device do not immerse it in liquid do not clean it with
63. oup at the same time 37743 2007 09 English Using your patient programmer 4 co Using your patient programmer 4 Parameter row Figure 4 16 Group Adjust on the Parameter row When the INCREASE or DECREASE x key is selected the GROUPADJUST screen is displayed Figure 4 17 E ll Figure 4 17 GROUPADUUST screen Each bar on the GROUPADJUST screen represents each program amplitude for the active group and the amount of adjustment available relative to the limits programmed by your clinician These bars increase or decrease as you increase or decrease the amplitudes English 37743 2007 09 1 Hold the patient programmer over your neurostimulator with the screen facing outward and press the NEUROSTIMULATOR ON NEUROSTIMULATOR OFF or SYNC key The THERAPY screen appears Notes To increase the amplitude the neurostimulator must be ON To decrease the amplitude the neurostimulator may be ON or OFF Verify that the group is active V and the selection box is located on the GROUPADJUST icon on the Parameter row Figure 4 16 Hold the patient programmer over your neurostimulator and press the INCREASE or DECREASE key The GROUPADJUST screen appears 37743 2007 09 English Using your patient programmer 4 ex Using your patient programmer 4 N 4 Hold the patient programmer over your neurostimulator and press the INCREASE or DECREASE C key
64. ovide you with information about your system alert you to a problem with your system or to guide you during patient programmer use Warning screens Warning screens indicate a problem with the patient programmer the antenna or the neurostimulator If the audio is ON three English 37743 2007 09 tones alert you to the message Table 5 1 describes warning screens and provides instructions see blue text on how to resolve the problem and clear the screen Table 5 1 Warning screens Screen Synchronize programmer and neurostimulator Cause and action The patient programmer and the neurostimulator must be synchronized Synchronize the patient programmer and neurostimulator Replace the external neurostimulator batteries The external neurostimulator batteries are depleted and stimulation is not available Replace the external neurostimulator batteries now Refer to the manual packaged with the external neurostimulator 37743 2007 09 English Troubleshooting 5 Table 5 1 Warning screens continued Screen Cause and action Replace the The patient programmer patient batteries are depleted programmer Programming is not possible batteries Replace the patient programmer batteries now Charge the The neurostimulator battery rechargeable charge level is low and implanted stimulation has stopped neurostimulator Charge the neurostimulator battery batter
65. pJe2 og eDed uonernuqiy q g9 eDed 2 SJojejnuuns ymo euog NO uonernumns uoneinums 10440 ul oDeuep juened ainpasoid aoinag s Yu hlu lul suuni sp l ul 891080 snoria i lA q H s seJnpeooud JO seoi ep WN3 10 S 2 4 enuelog Z lqEL 27 37743 2007 09 English 9G oDed Anoes s1o oelep yeu yol ebed sjeuDeui onnedejJoau UOHEIQE 9AeMOJOIUJ GG ebed 4H AouenbaJjoipeu 191 Adesau uoneipeu 9 onnedejeujouo Asg IHW Buibeuu eg oDed aoueuosal oneuBe N 091 ebed soJnpoeooud jose NO uone nuins kiniu uoneinums 10440 ul iuoned ainpasoidjaoinag ees jueniuugeju suuni 5 991490 cnoua lA q Aiejuawoy ues penunuoo seunpeooud JO SEDIASP wo N3 JO S jenuelog L Z AALL 2 uomeuuojur Adejeui jueuoduu English 37743 2007 09 28 2 uomeuuojur Adejeui jueuoduu 931 uonejnuins 801110 191 snooeue nosueJ 8p oDed punoseJjn onnedejau NO uonernumns funfui uonejnuins 10440 ul obewep juened ainpasoid aainaq ees jueniuugeju suuni sp l ul 221080 Snoua lA q Aezu woN Mes penunuoo seinpeooud JO S LA D wo N3 JO 5129 jenuelog L Z AA
66. plant site Charging system used with a rechargeable neurostimulator The charging system is used to charge the implanted rechargeable neurostimulator battery Understanding your therapy Stimulation delivers electrical pulses to the area where your pain signals will be blocked as they travel to the brain The electrical pulses are defined by parameters called amplitude pulse width and rate e Amplitude is the strength of the pulse It affects the stimulation strength or coverage required to manage your pain Pulse width is the duration of the pulse It affects the stimulation strength or coverage required to manage your pain 37743 2007 09 English Introduction to stimulation 3 A Introduction to stimulation 3 AR o Rate is the number of pulses delivered per second Rate feels like tapping A program delivers electrical pulses to a specified pain site Programs are combined into groups to provide stimulation to one or more pain sites A menu of groups can be designed to meet a patient s specific needs Typically each group is designed for particular activities symptoms or time of day For example Alex has pain in his low back and right thigh Typically Alex s pain doesn t vary however sometimes Alex has additional pain in his right ankle Alex s clinician designed two groups for Alex to choose from Group A is for Alex s typical pain group B is for the additional ankle pain Figure
67. ry level icon 61 Bone growth stimulators 158 Cardioversion 150 Carrying case 110 CAT scans 163 Cell phones 163 Change row 101 Changes in stimulation unexpected 35 82 Changing a group 83 84 Charging rechargeable neurostimulator 49 50 Charging system 43 45 Checking batteries external neurostimulator 67 68 implanted non rechargeable neurostimulator 73 74 implanted rechargeable neurostimulator 69 72 patient programmer 75 76 Clinician programmer 47 48 Communication screens 122 Complications system 23 English 37743 2007 09 Computerized axial tomography 163 Contraindications 21 Contrast preference 99 104 Cremation 143 CT scans 163 Decrease key 87 88 98 Decreasing a parameter 85 89 Defibrillation 150 Dental drills 158 Diathermy 21 148 Disposing of implanted neurostimulator 143 patient programmer 142 patient programmer batteries 142 Driving 36 Electrocautery 151 Electrolysis 158 Electromagnetic field devices 159 Electromagnetic interference EMI 24 29 148 164 Error codes 120 Extensions 44 External neurostimulator See Neurostimulator external Fluoroscopy 164 Group changing 83 84 description 46 47 Group Naming function icon text 105 108 Group row 61 62 Group row icons 63 Index 37743 2007 09 English 175 Index 176 GroupAdjust function 89 93 Hiking 35 Household items 162 Hyperbaric chambers 35 Identification label 111 Implanted non rechargeable neurostimulator See Neurostimulator
68. ry to replace or repair the neurostimulation system X ray equipment should be adjusted so it does not squeeze the neurostimulator too tightly e Magnetoencephalography MEG e Positron Emission Tomography PET scans Therapeutic magnets eg magnetic mattresses blankets wrist wraps elbow wraps Keep the magnet at least 25 cm 10 in away from your neurostimulator Magnetic fields of 10 gauss or less will generally not affect the neurostimulator English 37743 2007 09 Glossary Amplitude The strength or intensity of an electrical pulse Caution A statement describing actions that could result in damage to or improper functioning of a device Charging system Equipment used to charge the battery inside an implanted neurostimulator Clinician A healthcare professional such as a doctor or nurse Clinician programmer A device used by a clinician to send instructions to a neurostimulator Contraindication A condition or circumstance when a person should not have a neurostimulation system Diathermy A medical treatment applied to the outside of the body that delivers energy into the body Three types of energy that can be used are shortwave microwave and Glossary 37743 2007 09 English 165 Glossary 166 ultrasound Depending on the power level used diathermy devices may or may not produce heat within the body This treatment is typically used to relieve pain stiffness and
69. sh 37743 2007 09 Patient programmer Neurostimulator Internal antenna Figure 4 1 Placing the patient programmer over the neurostimulator The patient programmer is used to e turn the neurostimulator ON or OFF e change stimulation settings Note The patient programmer can be used with all the neurostimulator models referenced in this chapter however the available functions will be different for each model Be sure to note when a specific neurostimulator model is referenced to determine if the information is applicable for your neurostimulator Your clinician enables the available functions and specifies the settings you can adjust with 37743 2007 09 English Using your patient programmer 4 N Using your patient programmer 4 your patient programmer Discuss this with your clinician Synchronizing Synchronizing sends the settings from your neurostimulator to the patient programmer All communication with the neurostimulator begins with synchronization e To synchronize your neurostimulator and the patient programmer hold the patient programmer over your neurostimulator and press one of the three keys shown in Figure 4 2 Note Using the NEUROSTIMULATOR ON key to synchronize also turns ON the neurostimulator Using the NEUROSTIMULATOR OFF key to synchronize also turns OFF the neurostimulator English 37743 2007 09 Figure 4 2 Synchronizing your neurostimulator and patient progr
70. sible adverse effects 23 Changes in therapy 23 Possible system complications 23 Warnings 24 Precautions 31 37743 2007 09 English Contents c Contents o System and therapy 31 Patient activities 34 Individualization of treatment 36 Introduction to stimulation 39 How stimulation works 40 Parts of your system 42 Understanding your therapy 45 Controlling your stimulation 47 VVhat your clinician controls 48 VVhat you control 48 Charging a rechargeable neurostimulator 49 Recovery and care 51 Recovering from surgery 51 Activities 51 When to call your clinician 53 Care schedule 54 Using your patient programmer 55 Hovv the patient programmer vvorks 56 Synchronizing 58 Understanding the THERAPY screen 60 English 37743 2007 09 Using the NAVIGATOR key 65 Checking batteries 67 Checking the external neurostimulator battery 67 Checking the implanted rechargeable neurostimulator battery Models 37711 37712 37713 69 Checking the implanted non rechargeable neurostimulator battery Models 37701 and 37702 73 Checking the patient programmer batteries 75 Turning your neurostimulator ON or OFF 77 Scheduled Therapy 78 Adjusting stimulation settings 79 Changing a group 83 Increasing or decreasing a parameter amplitude pulse width or rate 85 Using GroupAdjust Models 37702 37712 and 37713 89 Using TARGETmyStim Models 37702 37712 and 37713 93 Summary of keys 96 37743 2007 09 English C
71. sing your patient programmer 4 co Notes Pressing and holding the INCREASE or DECREASE key changes the value every half second f one of the information screens in Table 4 9 appears you tried to increase or decrease the parameter beyond the limits programmed by your clinician or beyond the capabilities of your neurostimulator Table 4 9 Parameter limit screens Lower limit le You tried to decrease a parameter below the lowest value allowed lower limit Press any arrow on the NAVIGATOR key to clear the screen Upper limit all F T You tried to increase a parameter above the highest value allowed upper limit Press any arrow on the NAVIGATOR key to clear the screen English 37743 2007 09 Table 4 9 Parameter limit screens continued Upper You tried to increase limit a parameter above OOR what your neurostimulator can P deliver al f ut 00R 00R oor Press any arrow on the NAVIGATOR key to clear the screen Using GroupAdjust Models 37702 37712 and 37713 If your implanted neurostimulator is a Model 37702 PrimeADVANCED a Model 37712 RestoreULTRA or a Model 37713 RestoreADVANCED and your clinician enabled the GroupAdjust function the GROUPADJUST icon will appear in the Parameter row Figure 4 16 GroupAdjust may be used to adjust all program amplitudes for the active gr
72. stimulator battery before the battery is overdischarged Refer to the manual packaged with the charging system for more information N Caution Charge the neurostimulator when you see a low battery screen on the patient programmer or recharger this prevents the battery from overdischarging see glossary If the neurostimulator battery is allowed to overdischarge charging is not possible however the clinician may be able to restore the battery function 37743 2007 09 English Introduction to stimulation 3 A Introduction to stimulation 3 Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways e Battery function is restored however charging sessions may be more frequent because battery capacity has been reduced e Battery function is not restored and the neurostimulator must be surgically replaced Battery function is not restored because The neurostimulator battery is permanently damaged The neurostimulator battery has been overdischarged and restored twice before The third time the battery is overdischarged the neurostimulator will reach end of service Surgery is required to replace the neurostimulator English 37743 2007 09 Recovery and care Recovering from surgery It takes several weeks to heal from surgery It is normal to feel some discomfort from the incision s and to have some pain at the
73. t the hospital After Medtronic receives your implant registration from the hospital you vvill receive a permanent identification card English 37743 2007 09 2 Important therapy information Important therapy information 2 N e Purpose of the device The Medtronic Model 37743 Patient Programmer is designed to program the following Medtronic neurostimulators Rechargeable Model 37711 Restore Model 37712 RestoreULTRA Model 37713 RestoreADVANCED Non rechargeable Model 37701 RestorePRIME Model 37702 PrimeADVANCED Model 37022 External Neurostimulator ENS English 37743 2007 09 Purpose of the neurostimulation system indications Refer to the indications sheet that is packaged with the patient programmer for the purpose of the neurostimulation system and related information Therapies that may not be used with the neurostimulation system contraindications Diathermy Inform anyone treating you that you CANNOT have any shortwave diathermy microwave diathermy or therapeutic ultrasound diathermy all now referred to as diathermy anywhere on your body because you have an implanted neurostimulation system Energy from diathermy can be transferred through your implanted system and can cause tissue damage resulting in severe injury or death Refer to Appendix A Electromagnetic interference EMI beginning on page 148 for more information 37743 2007 09 English
74. to increase or decrease the amplitude as needed 5 Once the desired levels are displayed release the INCREASE or DECREASE C key to save the amplitude adjustment and to return to the THERAPY screen Notes One program amplitude represented by one of the bars may reach its upper or lower limit while the other program amplitudes have not The program that has reached its upper or lower limit will stop increasing or decreasing while the other programs will continue increasing or decreasing until they have also reached their limits When all programs in the group have reached either their upper or lower limits an information screen will be English 37743 2007 09 displayed stating that the limit has been reached see Table 4 9 on page 88 Using TARGETmyStim Models 37702 37712 and 37713 If your implanted neurostimulator is a Model 37702 PrimeADVANCED Model 37712 RestoreULTRA or a Model 37713 RestoreADVANCED and your clinician has programmed TARGETmyStim the TARGETMYSTIM icon will appear in the Parameter row Figure 4 18 TARGETmyStim allows you to make adjustments to your therapy by moving the lead array active electrodes up or down one level OG amp MA t 3 5 Parameter row Figure 4 18 TARGETmyStim on Parameter row The small metal electrodes near the tip of the lead are not all active at the same time Only 37743 2007 09 English Using your patient programmer 4
75. to deliver stimulation to one or more pain sites THERAPY screen The main screen displayed on the patient programmer Warning A statement describing an action or situation that could harm the patient Warning screen A screen displayed on the patient programmer that alerts you to a problem with the programmer antenna or neurostimulator 37743 2007 09 English Glossary 171 Index Activities 34 35 51 Adjusting stimulation guidelines for 80 82 settings 85 96 Adverse effects 23 Amplitude description 45 increasing or decreasing 85 89 reduce to lowest setting 36 Antenna detachable 111 113 Antenna internal patient programmer 56 57 Audio changing preference 99 104 tones 80 116 123 Backlight Power Backlight key 98 Batteries external neurostimulator checking 67 68 low battery level screen 128 replace warning screen 117 replacing 67 Batteries patient programmer checking 75 76 disposing of 142 replacing 108 Battery implanted non rechargeable neurostimulator checking 73 74 low battery level screen 129 130 replacing 73 Index 37743 2007 09 English 173 Index 174 Battery implanted rechargeable neurostimulator charging 49 50 checking 69 72 low battery charge level screen 127 recharge warning screen 118 Battery charge level low screen 127 Battery level low screen external neurostimulator 128 implanted non rechargeable neurostimulator 129 patient programmer 128 Batte
76. tor battery charge level is low and stimulation will not be available Soon Charge your implanted neurostimulator battery Refer to the manual packaged with the charging system 37743 2007 09 English Troubleshooting 5 N Table 5 3 Information screens continued Screen Description and action External The external neurostimulator neurostimulator batteries are low and stimulation batteries are lovv will not be available soon Replace the external Es neurostimulator batteries Refer to the manual packaged with the external neurostimulator Patient The patient programmer programmer batteries are low You can finish batteries are low programming Replace the patient programmer batteries before the batteries become depleted Synchronize You tried increasing or decreasing a parameter for an inactive group eO Synchronize the patient programmer and neurostimulator Troubleshooting 5 128 English 37743 2007 09 Table 5 3 Information screens continued Screen Description and action Implanted The implanted neurostimulator is neurostimulator nearing end of service is nearing end of Stimulation will not be available service Soon Call your clinician to schedule A e a visit Y You may clear this screen and return to the THERAPY screen by pressing any arrow on the NAVIGATOR key This screen reappears daily After clearing this screen a low battery level ic
77. ttom of the screen Error codes 0 to 252 Remove batteries from the patient programmer wait several seconds then re insert the batteries If the error message appears again call your doctor Other codes Write down the code shown on the screen Call your doctor Call your doctor Your neurostimulator has reached end of service A e Stimulation is not available 7 Call your doctor EOS LO 2 Call your doctor Your neurostimulator has been I reset Stimulation is not A available d v amp dy Call your doctor POR 120 English 37743 2007 09 Table 5 1 Warning screens continued Screen Device not supported A Cause and action The implanted device that you are attempting to communicate with is not compatible with the patient programmer Call your doctor 37743 2007 09 English Troubleshooting 5 121 Communication screens The communication screens show you that a process is in progress Table 5 2 describes the communication screens for your neurostimulation system The communication screens automatically clear when the neurostimulation system finishes the process Table 5 2 Communication screens Screen Description and action Communication The patient programmer is communicating with the implanted neurostimulator The patient programmer is communicating with the external neurostimulator Troubleshooting 5 122 English 37743 2007 09 Informat
78. u Table 4 3 Table 4 3 Parameter row icons Row Icons Description Parameter 1234 Amplitude al 1 234 Pulse width Rate ul GroupAdlust refer to page 89 t TARGETmyStim refer to page 93 f you cannot change any parameters this row is blank The NAVIGATOR key on the patient programmer allows you to move between rows and display all the information for each row English 37743 2007 09 Using the NAVIGATOR key The NAVIGATOR key Figure 4 4 is used to navigate between and across the rows on the THERAPY screen Figure 4 4 NAVIGATOR key The selection box on the THERAPY Screen acts as a cursor to show which row is selected for programming If there is more information on the row than can be displayed the OPTIONS 4 icon will appear next to the selection box Figure 4 5 37743 2007 09 English Using your patient programmer 4 o c Using your patient programmer 4 o o Gm um A Selection box ial 3 50 Options icon Figure 4 5 OPTIONS icon and selection box ae The NAVIGATOR key moves the selection box The arrows on the NAVIGATOR key indicate the direction the selection box will move e To move the selection box between rows press the up A and down WY arrows on the NAVIGATOR key e To move the selection box across a row that continues press the left 4 and right gt arrows on the NAVIGATOR key e When moving the selection box with the NAVIGATOR key you
79. ulator batteries are depleted and stimulation is not available Replace the external neurostimulator batteries now Refer to the manual packaged with the external neurostimulator English 37743 2007 09 Checking the implanted rechargeable neurostimulator battery Models 37711 37712 37713 Check the implanted neurostimulator battery charge level every day e To check the implanted neurostimulator battery charge level hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key The THERAPY screen appears displaying the implanted neurostimulator battery level Figure 4 7 Battery charge level Go zs M A ful 3 504 C3 Gi Gao Cn Ge Charge Full neurostimulator Figure 4 7 Implanted neurostimulator charge level on the THERAPY screen 37743 2007 09 English Using your patient programmer 4 o Using your patient programmer 4 When the neurostimulator battery charge level is low charge the battery as described in the manual packaged with the charging system Your implanted neurostimulator battery can be charged many times however eventually the neurostimulator will need to be replaced N Caution Charge the neurostimulator when you see a low battery 3 screen on the patient programmer or recharger this prevents the battery from overdischarging see glossary If the neurostimulator battery is allowed to overdischarge charging
80. umber format preference 99 104 Index 37743 2007 09 English 177 Index 178 Options icon 65 Parameter description 45 increasing or decreasing 85 89 Parameter row 61 Parameter row icons 64 Patient identification card 18 Patient programmer batteries 75 76 108 110 cleaning and care 33 140 description 44 47 48 56 57 disposing of 142 keys 96 98 lovv battery level screen 128 preferences 99 104 purpose 20 replace batteries warning screen 118 replacing batteries 108 troubleshooting 135 136 turning ON and OFF 98 Positron Emission Tomography PET scans 164 Power tools 36 Power Backlight key 96 98 Precautions 31 36 Preference icons 99 Preferences changing 99 104 Pregnancy 37 PrimeADVANCED neurostimulator See Neurostimulator implanted non rechargeable English 37743 2007 09 Programmer See Patient programmer Programs 46 47 Psychotherapeutic procedures 161 Pulse width description 45 increasing or decreasing 85 89 Radiation therapy 161 Radiofrequency RF ablation 155 Rate description 46 increasing or decreasing 85 89 Repair 142 Restore neurostimulator See Neurostimulator implanted rechargeable RestoreADVANCED neurostimulator See Neurostimulator implanted rechargeable RestorePRIME neurostimulator See Neurostimulator implanted non rechargeable RestoreULTRA neurostimulator See Neurostimulator implanted rechargeable Scheduled Therapy 79 Scuba diving 35 Security devices 156 Serial number 137
81. us row M A al 3 50 Figure 4 21 Accessing preferences from the Status row 3 Press the left 4 or right gt arrow on the NAVIGATOR key to move the selection box to the desired preference Figure 4 22 Using your patient programmer 4 Figure 4 22 Moving to the desired preference 100 English 37743 2007 09 4 Press the down W arrow to move the selection box to the Change row Figure 4 23 m Change row 4 Figure 4 23 Change rovv for selected preference 5 Follovv the steps in Table 4 12 to change the selected preference Table 4 12 Changing preferences Audio 1 Press the left lt or right arrow on the NAVIGATOR Key to move the selection box to audio ON 4 or OFF 2 2 Go to step 6 page 103 Contrast 1 Press the left 4 or right b arrovv on the NAVIGATOR key to make the contrast lighter O or darker 2 Go to step 6 page 103 Using your patient programmer 4 37743 2007 09 English 101 Using your patient programmer 4 102 Table 4 12 Changing preferences continued Time 1 Press the left lt or right arrovv on the NAVIGATOR key to move the selection box to the hour minutes or time of day A or P Press the INCREASE or DECREASE key to change the selection Press the up A arrow on the NAVIGATOR key to return the selection box to the Status row Press the left 4 or right gt arrow on the NAVIGATOR k
82. west setting before adjusting the pulse width or rate and after turning OFF the neurostimulator 2 Verify that the group is active Vf and that the selection box is located on the Parameter row 37743 2007 09 English Using your patient programmer 4 co c Using your patient programmer 4 00 o 3 Press the left 4 or right p arrow on the NAVIGATOR key to move the selection box to the desired parameter and program Figure 4 14 t5 E ua Q gt ul 3 50 ul 3 50 Figure 4 14 Moving to the desired parameter Notes Only one parameter for one program can be displayed at a time on the parameter row Scrolling to the right displays the amplitude 21 for each program followed by the pulse width for each program and then the rate 7 Scrolling to the left reverses the order The program is designated by the number above the AMPLITUDE or PULSE WIDTH icon English 37743 2007 09 There will not be a number above the RATE icon because the rate is the same for all programs in a group Hold the patient programmer over your neurostimulator and press the INCREASE or DECREASE key to increase or decrease the selected parameter as needed Figure 4 15 The increase or decrease occurs immediately and is saved in the neurostimulator DECREASE INCREASE Figure 4 15 DECREASE and INCREASE keys 37743 2007 09 English Using your patient programmer 4 J U
83. y now Refer to the A manual packaged vvith the charging system On Troubleshooting 5 118 English 37743 2007 09 Table 5 1 Warning screens continued Screen Cause and action Caution Charge the neurostimulator when you see a low battery 1 screen on the patient programmer or recharger this prevents the battery from overdischarging see glossary If the neurostimulator battery is allowed to overdischarge charging is not possible however the clinician may be able to restore the battery function Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways Battery function is restored however charging sessions may be more frequent because battery capacity has been reduced Battery function is not restored and the neurostimulator must be surgically replaced Battery function is not restored because The neurostimulator battery is permanently damaged The neurostimulator battery has been overdischarged and restored twice before The third time the battery is overdischarged the neurostimulator will reach end of service Surgery is required to replace the neurostimulator 37743 2007 09 English Troubleshooting 5 Table 5 1 Warning screens continued Screen Cause and action Call your doctor The system is not working correctly Stimulation may have A e stopped ay Read the error code at the bi bo

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