PATIENT PROGRAMMER 97740

Transcription

1 PATIENT PROGRAMMER Pain therapy user manual for neurostimulation system models 37022, 37701, 37702, 37703, 37704, 37711, 37712, 37713, 37714, 97702, 97712, 97713, 97714! USA Rx only 2013

2 Medtronic, AdaptiveStim, GroupAdjust, Itrel, PrimeAdvanced, Restore, RestoreAdvanced, RestorePrime, RestoreSensor, RestoreUltra, SoftStart/Stop, SureScan, and TargetMyStim are trademarks of Medtronic, Inc., registered in the U.S. and other countries.! USA FCC Information The following is communications regulation information on the Model Patient Programmer. FCC ID: LF This device complies with Part 15 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. This device complies with Industry Canada licenseexempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that my cause undesired operation of the device.

3 Label Symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123) and R&TTE Directive 1999/5/EC. Consult instructions for use Manufacturer Serial number EC REP XX C XXX F -XX C -XX F Authorized Representative in the European Community Temperature limitation Non-ionizing electromagnetic radiation IEC /EN , Type BF Equipment Antenna jack Label Symbols English 3

4 MR Magnetic Resonance (MR) Unsafe System meets the applicable Canadian (CAN/CSA-C22.2 No ) electrical safety standard requirements. Chinese Standard (SJ/T ) Logo: Electronic Information Products Pollution Control Symbol. (The date in this logo means the environmental protection use period of the product.) Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See recycling.medtronic.com for instructions on proper disposal of this product. For USA audiences only Label Symbols 4 English

5 Table of contents Label Symbols 3 Glossary 12 1 Introduction 20 How to use this manual 20 Patient guides 22 Patient identification card 25 2 Important therapy information 28 Purpose of the device 28 Purpose of the neurostimulation system (indications) 29 Description of your system 29 Therapies that may not be used with the neurostimulation system (contraindications) 34 Risks and benefits 34 Risks of surgery 35 Warnings 35 Precautions 43 Table of contents English 5

6 Table of contents Individualization of Treatment 49 3 Recovery and care after surgery 52 Recovery from surgery 52 Activities 52 When to call your clinician 54 Care schedule 54 4 Using your patient programmer 56 How the patient programmer works 56 Patient programmer Therapy screen 58 Status row 59 Group row 61 Parameter row 63 Patient programmer keys 64 Using the Sync key 66 Using the Navigator key 68 Turning your neurostimulator on or off 70 How to maintain the neurostimulator batteries 72 6 English

7 Checking the external neurostimulator battery 72 Checking the implanted rechargeable neurostimulator battery 74 Checking the implanted nonrechargeable neurostimulator battery 79 Changing patient programmer preferences 81 Using the carrying case and labeling the patient programmer 89 Using the detachable antenna 91 5 Adjusting your stimulation 96 Introduction 96 Stimulation features 96 Adjusting stimulation settings 99 Increasing or decreasing a parameter (amplitude, pulse width, or rate) 104 Changing back to clinician settings 108 (Models 37022, 37702, 37712, 37713, 37714, 97702, 97712, 97713, 97714) 108 Viewing and changing a group 111 Table of contents English 7

8 Table of contents (Models 37022, 37701, 37702, 37711, 37712, 37713, 37714, 97702, 97712, 97713, 97714) 111 Displaying group names 114 Using GroupAdjust 116 (Models 37022, 37702, 37712, 37713, 37714, 97702, 97712, 97713, 97714) 116 Viewing Scheduled Therapy 119 (Models 37022, 37701, 37702, 37711, 37712, 37713, 97702, 97712, 97713) 119 Using TargetMyStim 121 (Models 37022, 37702, 37712, 37713, 37714, 97702, 97712, 97713, 97714) 121 Using AdaptiveStim 124 (Models 37714, 97714) 124 AdaptiveStim groups and positions 126 Turning AdaptiveStim on and off 129 Making adjustments to AdaptiveStim MRI examinations 136 If you have an MRI appointment 136 Responsibilities of the patient in preparing for the MRI appointment English

9 At the MRI appointment 137 Placing your neurostimulation system in MRI mode for the MRI scan 139 Using the Model patient programmer to activate MRI mode 140 Activating MRI mode 141 Turning stimulation back on after the MRI scan 148 For neurostimulators with SureScan MRI Technology (Models 97702, 97712, 97713, 97714) Maintenance 156 Patient programmer batteries 156 Checking the patient programmer batteries 156 Replacing the patient programmer batteries 158 Cleaning and care 160 Safety and technical checks 161 Battery and patient programmer disposal 162 Neurostimulator disposal 162 Table of contents English 9

10 Table of contents Specifications Troubleshooting 166 Patient programmer screens 166 Warning screens 166 Information screens 170 Communication screens 179 Possible problems and solutions Additional information 188 How stimulation works 188 Controlling your stimulation 193 What your clinician controls 193 What you control 193 Possible adverse effects 194 Changes in therapy 194 Possible system complications User assistance 198 User assistance 198 Declaration of Conformity Appendix A: Electromagnetic interference (EMI) 202 Contraindication English

11 Warnings 203 Precautions 214 Notes 218 Index 222 Table of contents English 11

12 Glossary Caution - A statement describing actions that could result in damage to or improper functioning of a device. 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. Glossary 12 English

13 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 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 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) - The neurostimulator has reached the scheduled end of service and no longer delivers the electrical pulses that block pain signals. Glossary English 13

14 ERI (Elective replacement indicator) - The neurostimulator is nearing scheduled end of service. 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. Indication - The purpose of the neurostimulation system and the medical condition for which it may be implanted. Neurostimulation system - The implanted and external components of the stimulation system that delivers electrical pulses to block pain signals as they move to the brain. Glossary 14 English

15 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. OOR (Out of regulation) - The neurostimulator battery is unable to produce the levels of energy required for the current stimulation settings. Overdischarge - The neurostimulator battery continues to lose charge even after you see a low battery screen. Eventually, the battery loses enough charge to permanently affect the neurostimulator. If this occurs, the battery is overdischarged. Parameter - One of three stimulation settings that adjust the electrical pulse: amplitude, pulse width, and rate. Glossary English 15

16 POR (Power on reset) - The neurostimulator battery has caused the electronic circuitry in the neurostimulator to be reset. Precaution - See Caution. Program - Stimulation directed to a specific pain site. Recharger - The component of the neurostimulation system that is used to recharge your neurostimulator battery. 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. Glossary 16 English

17 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 cliniciandefined limits. 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 to deliver stimulation to one or more pain sites. Glossary English 17

18 Therapy impedance measurements - Impedance and stimulation current measurements taken at the programmed settings. Therapy settings - A specific combination of amplitude, rate, and pulse width parameters acting on a specific electrode set that determines the stimulation pulses that are delivered. Warning - A statement describing an action or situation that could harm the patient. Glossary 18 English

19 1 Introduction

20 Introduction 1 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. A glossary is included at the beginning of this manual. Chapter 1 "Introduction" describes the patient documents your clinician should have provided to you. Chapter 2 "Important therapy information" describes when you should and should not use a neurostimulation system, the neurostimulation system components, and the risks, benefits, warnings, precautions, and patient activities related to your neurostimulation system. Chapter 3 "Recovery and care after surgery" provides information about recovering from surgery, activity and care information, and when to contact your clinician. 20 English

21 Chapter 4 "Using your patient programmer" describes the patient programmer and how to perform specific tasks. Chapter 5 "Adjusting your stimulation" describes how to adjust your stimulation using your patient programmer. Chapter 6 "MRI examinations" provides information about what you should do if you have an MRI examination. Chapter 7 "Maintenance" describes how to care for your patient programmer, including how to change the batteries, and lists the specifications for the patient programmer and the implanted neurostimulation system. Chapter 8 "Troubleshooting" describes patient programmer warning and information screens and how to solve possible problems. Chapter 9 "Additional information" describes how stimulation works, possible Introduction English 21

22 Introduction 1 adverse effects, changes in therapy, and possible system complications. Chapter 10 "User assistance" describes where to find the patient programmer serial number and who to contact if the patient programmer is lost or broken. Chapter 11 "Appendix A: Electromagnetic interference (EMI)" provides more information about electromagnetic interference. Patient guides Table 1.1 on page 23 describes the documents you should receive after a neurostimulator is implanted. Notes: If your implantable neurostimulator (INS) has a rechargeable battery, you should receive documents for the neurostimulator charging system. If you have an external neurostimulator you will receive the Medtronic Model 22 English

23 37022 External Neurostimulator: Test Stimulation Patient Guide. This manual describes the goals, activities, components, and instructions for test stimulation. Table 1.1 Patient guides for an implanted neurostimulator Patient guide Rechargeable Nonrechargeable Medtronic Model X X Patient Programmer: Pain Therapy User Manual. See page 20 for details. Medtronic Model Patient Programmer: Quick Reference Guide. Provides instructions for common patient programmer tasks. X X Introduction English 23

24 Table 1.1 Patient guides for an implanted neurostimulator (continued) Introduction 1 Patient guide Rechargeable Nonrechargeable Medtronic Model Recharger: Charging System User Manual. Describes the charging system and how to use it with a rechargeable neurostimulator. Medtronic Model Recharger: Charging System Quick Reference Guide. Provides instructions for common recharging tasks. Patient Identification Card. Provides information about you, your implanted neurostimulator, and your doctor. X X X X 24 English

25 Patient identification card When you leave the hospital, your doctor will give you a patient identification card. This card supplies information about you, your implanted device, and your doctor. Your identification card may allow you to bypass security devices. Carry this card with you at all times and bring this card with you to all MRI appointments (see Chapter 6 "MRI examinations"). If 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.! USA A temporary identification card will be provided at the hospital. After Medtronic receives your implant registration from the hospital, you will receive a permanent identification card. Introduction English 25

26 Introduction 1 26 English

27 2 Important therapy information

28 Important therapy information 2 Purpose of the device The Medtronic Model Patient Programmer is designed to program the following Medtronic neurostimulators: Rechargeable Restore Model RestoreUltra Model RestoreUltra with SureScan MRI Technology Model RestoreAdvanced Model RestoreAdvanced with SureScan MRI Technology Model RestoreSensor Model RestoreSensor with SureScan MRI Technology Model Nonrechargeable Model External Neurostimulator RestorePrime Model PrimeAdvanced Model English

29 PrimeAdvanced with SureScan MRI Technology Model Itrel 4 Models and Refer to your patient identification card to determine the model number of your neurostimulator. 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. Description 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 of a neurostimulation system include (Figure 2.1): Important therapy information English 29

30 a neurostimulator 1 or 2 leads 1 or 2 extensions (optional) Neurostimulator Extensions Leads Important therapy information 2 Electrodes Figure 2.1 Implanted parts of a typical neurostimulation system (spinal cord stimulation shown). A typical neurostimulation system also includes an external patient programmer for controlling your system. If you have a rechargeable neurostimulator, your system also includes a charging system (Figure 2.2). 30 English

31 Patient programmer Charging system (rechargeable neurostimulator) Detachable antenna (optional) Carrying case Figure 2.2 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 whether Important therapy information English 31

32 Important therapy information 2 an implanted neurostimulator is the right choice for you. Note: Some implanted neurostimulator models include a rechargeable battery. Rechargeable neurostimulators Restore Model RestoreUltra Model RestoreUltra with SureScan MRI Technology Model RestoreAdvanced Model RestoreAdvanced with SureScan MRI Technology Model RestoreSensor Model RestoreSensor with SureScan MRI Technology Model Non-rechargeable neurostimulators RestorePrime Model PrimeAdvanced Model English

33 PrimeAdvanced with SureScan MRI Technology Model Itrel 4 Models and 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. Not all neurostimulation systems include an extension. Patient programmer A patient programmer is a hand-held device that you use to select and adjust your stimulation. A detachable antenna is also available if you have difficulty reaching the neurostimulator implant site (refer to "Using the detachable antenna" on page 91). Charging system used with a rechargeable neurostimulator The charging system is used to charge the Important therapy information English 33

34 Important therapy information 2 implanted rechargeable neurostimulator battery. 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. 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 34 English

35 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. Warnings Electromagnetic interference Electromagnetic interference (EMI) 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 Important therapy information English 35

36 Important therapy information 2 devices and magnets encountered in a normal day are unlikely to affect the operation of a neurostimulator. However, sources of strong EMI can result in the following: 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 or off (particularly in a neurostimulator enabled for magnet use) or to reset to power-on-reset (POR) values, resulting in loss of neurostimulation, return of underlying symptoms, and in the case of POR, requiring your health care provider to reprogram the neurostimulator. Unexpected changes in stimulation, causing a momentary increase in 36 English

37 stimulation or intermittent stimulation, which some patients have described as a jolting or shocking sensation. Although the unexpected change in stimulation may feel uncomfortable, it does not damage the device or injure a patient directly. In rare cases, as a result of the unexpected change in stimulation, patients have fallen down and been injured. Refer to the following table for information on the effect of EMI on you and your neurostimulation system. Additional information and instructions on how to reduce the risk from EMI are located in Appendix A of this manual. Important therapy information English 37

38 Important therapy information 2 Table 2.1 Potential effects of EMI from devices or procedures Device or procedure Bone growth stimulators Serious patient injury Device damage Device turns off/on Momentary increase in stimulation Intermittent stimulation X X X CT scans X Defibrillation/ X X X X cardioversion Dental drills X and ultrasonic probes Diathermy, X X X therapeutic Electrocautery X X Electrolysis X X 38 English

39 Table 2.1 Potential effects of EMI from devices or procedures (continued) Device or procedure Electromagneti c field devices (eg, arc welding, power stations) High-output ultrasonics / lithotripsy Household items Laser procedures Serious patient injury Device damage X X Device turns off/on Momentary increase in stimulation Intermittent stimulation X X X X X Important therapy information English 39

40 Important therapy information 2 Table 2.1 Potential effects of EMI from devices or procedures (continued) Device or procedure Magnetic resonance imaging (MRI) Psychotherape utic procedures Radiation therapy Radiofrequency (RF) / microwave abl ation Serious patient injury Device damage Device turns off/on Momentary increase in stimulation Intermittent stimulation X X X X X X X X X X X X X 40 English

41 Table 2.1 Potential effects of EMI from devices or procedures (continued) Device or procedure Theft detector or security device Therapeutic magnets Therapeutic ultrasound Transcutaneou s electrical nerve stimulation (TENS) Serious patient injury Device damage Device turns off/on Momentary increase in stimulation Intermittent stimulation X X X X X X X X X Important therapy information English 41

42 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 implanted cardiac devices When a neurostimulator and an implanted cardiac device (eg, pacemaker, defibrillator) are required, the doctors involved with both devices (eg, neurologist, neurosurgeon, cardiologist, cardiac surgeon) should discuss the possible interactions 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. Defibrillation therapy from an implanted defibrillator can damage the neurostimulator. The electrical pulses from the neurostimulation system could affect with the sensing operation from the cardiac device and result in inappropriate responses from the cardiac device.your 42 English

43 doctor should program 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 should be turned off during programming to prevent unintended audible clicks. Programmer interaction with other active implanted devices If you have a neurostimulator and another active implanted device: Important therapy information English 43

44 Important therapy information 2 the radio-frequency (RF) signal used to program either device can reset or reprogram the other device the magnet in a cardiac programmer can activate magnetically controlled functions in the 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 either device. Component compatibility For proper therapy, use only Medtronic Neuromodulation components that are prescribed by your physician. Patient control devices may affect other implanted devices Do not place patient control devices (eg, patient programmer) over 44 English

45 another device (eg, pacemaker, defibrillator, another neurostimulator). The patient control device could accidently change the operation of another device. Patient programmer handling To avoid damaging the patient programmer, do not immerse the device in liquid; do not clean it with bleach, nail polish remover, mineral oil, or similar substances; and do not drop it or handle it in a way that might damage it. Patient device use When operating an external neurostimulator, patient programmer, or charging system, use special care near flammable or explosive atmospheres. An interaction between the flammable or explosive atmospheres and the battery in the device could occur. The consequences of using a battery-powered device near flammable or explosive atmospheres are unknown. Communication interference from EMI When using your patient programmer to communicate with your neurostimulator, move away from equipment that may Important therapy information English 45

46 Important therapy information 2 generate electromagnetic interference (EMI) or turn off the likely source of EMI. EMI may disrupt communication between the patient programmer and neurostimulator. Examples of EMI sources are computer monitors, cellular telephones, and motorized wheelchairs. Patient programmer modification Do not modify this equipment. Modification of this equipment can result in damage to the programmer, causing the programmer to malfunction or become unusable. Patient activities Please read the following important information about activities to avoid. Activities requiring excessive twisting or stretching Avoid activities that may 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 loss 46 English

47 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 (twiddler s syndrome) 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 cannot be charged. Scuba 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. Important therapy information English 47

48 Important therapy information 2 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 precaution to not put undue stress on your implanted 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 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 be unsafe for you or others if you received an unexpected jolt or shock (eg, driving, operating power tools). Discuss these activities with your doctor. 48 English

49 Individualization 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 selfcare responsibilities. Maximum benefits from the neurostimulation system require longterm postsurgical management. Patient selection The neurostimulation system should not be implanted if: your symptoms are not of physiological origin, you are not an appropriate candidate for surgery, you cannot properly operate the system, or 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: Important therapy information English 49

50 Pregnancy, unborn fetus, or delivery Pediatric use (patients under the age of 18) Important therapy information 2 50 English

51 3 Recovery and care after surgery

52 Recovery 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 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. Recovery and care after surgery 3 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. Avoid activities where you must bend, stretch, or twist your body; these movements can move your leads, which affects your stimulation. 52 English

53 Avoid lying on your stomach. Avoid reaching over your head. Avoid turning from side to side. Avoid bending forward, backward, or from side to side. Avoid lifting more than 2 kilograms (5 pounds). As you begin to feel better, you should be able to perform activities such as: Bathing or showering Sexual activity Working at home or at your business Hobbies or activities, such as walking, gardening, cycling, or swimming Traveling 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 could not perform before your Recovery and care after surgery English 53

54 surgery. Discuss your activity level with your doctor. Recovery and care after surgery 3 When to call your clinician Contact your clinician if any of the following events occur: 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 clinician. Your system is not working properly. You cannot turn the neurostimulator on or off. You cannot adjust stimulation using your patient programmer. Care schedule Your clinician will schedule follow-up visits to make sure you are receiving the most appropriate therapy. 54 English

55 4 Using your patient programmer

56 Using your patient programmer 4 How the patient programmer works The patient programmer communicates with your neurostimulator by sending signals to and receiving signals from the neurostimulator. Your neurostimulator only accepts communications from the patient programmer or clinician programmer. Sending information from the neurostimulator to the patient programmer is called "synchronizing." To synchronize the neurostimulator and the patient programmer, the antenna of the patient programmer must be placed directly over the neurostimulator (Figure 4.1). Notes: Keep your patient programmer accessible at all times. The internal antenna is on the back of the patient programmer. The patient programmer screen must face outward. 56 English

57 An optional detachable external antenna is available for patients who have difficulty reaching their neurostimulator (refer to page 91). Patient programmer with internal antenna Neurostimulator Figure 4.1 Placing the patient programmer over the neurostimulator. Use the patient programmer to: turn the neurostimulator on or off. check the neurostimulator battery. change stimulation settings. Using your patient programmer English 57

58 Using your patient programmer 4 Notes: The patient programmer can be used with all the neurostimulator models referenced in this manual; 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. Figures in this chapter present information common to rechargeable and nonrechargeable neurostimulators. Some figures may display battery level icons that are unique to rechargeable neurostimulators. Patient programmer Therapy screen The Therapy screen displays icons and numbers that indicate your neurostimulator and patient programmer status and your stimulation settings (Figure 4.2). 58 English

59 Rechargeable Nonrechargeable Figure 4.2 Therapy screen. 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. Information on the Therapy screen is arranged in three rows: the Status row, the Group row, and the Parameter row. Status row The Status row is the top row of the Therapy screen (Figure 4.3). Using your patient programmer English 59

60 Status row Rechargeable Nonrechargeable Figure 4.3 Status row on Therapy screen. Using your patient programmer 4 Icons on the Status row indicate the neurostimulator on or off status and the patient programmer battery level status. If you have a rechargeable neurostimulator, the Status row also displays the rechargeable neurostimulator battery charge level status. Refer to Table 4.1 for a description of the icons that may appear on the Status row. Icon Table 4.1 Status row icons Description Neurostimulator is off (Implanted or external neurostimulator) Neurostimulator is on (Implanted or external neurostimulator) 60 English

61 Table 4.1 Status row icons (continued) Icon Description Neurostimulator is on and AdaptiveStim is enabled Implanted rechargeable neurostimulator battery charge level The implanted rechargeable neurostimulator battery charge level is low The implanted nonrechargeable neurostimulator is near the end of service External neurostimulator battery level Patient programmer battery level Group row The Group row is the middle row of the Therapy screen (Figure 4.4). The Group row will only appear on the Therapy screen if your neurostimulator supports the Group feature and your clinician has programmed the Group setting. Using your patient programmer English 61

62 Group row Rechargeable Nonrechargeable Figure 4.4 Group row on Therapy screen. The icons on the Group row indicate the name of the group and whether or not the group is active. Refer to Table 4.2 for a description of the icons that may appear on the Group row. Using your patient programmer 4 Icon Table 4.2 Group row icons Description Active Not active Group name (can be icons or text) Scheduled Therapy AdaptiveStim position (can be this icon or text) 62 English

63 Parameter row The Parameter row is the bottom row of the Therapy screen (Figure 4.5). Parameter row Rechargeable Nonrechargeable Figure 4.5 Parameter row on Therapy screen. The icons on the Parameter row indicate the parameter settings currently in use for your stimulation and provide information about specific stimulation settings available for your neurostimulator. Refer to Table 4.3 for a description of the icons that may appear on the Parameter row. Icon Table 4.3 Parameter row icons Description Amplitude Using your patient programmer English 63

64 Table 4.3 Parameter row icons (continued) Icon Description Pulse width Rate GroupAdjust 1 TargetMyStim AdaptiveStim position Patient programmer keys Using your patient programmer 4 Decrease Neurostimulator on Neurostimulator off Sync Navigator Increase Power / Backlight Figure 4.6 Patient programmer keys. 64 English

65 Table 4.4 Patient programmer keys Key Sync Navigator On Off Function Synchronizes the neurostimulator and patient programmer. Activates a selected group. The patient programmer must be held over the neurostimulator while pressing the Sync key. Moves the selection box on the Therapy screen. Clears the information screens. Turns the neurostimulator on or off. The patient programmer must be held over the neurostimulator while pressing the Neurostimulator on key or Neurostimulator off key. Pressing either of these keys also automatically synchronizes the neurostimulator and patient programmer and displays the Therapy screen. Using your patient programmer English 65

66 Table 4.4 Patient programmer keys (continued) Using your patient programmer 4 Key Power / Backlight Decrease Increase Using the Sync key Function Pressing and releasing this key turns the patient programmer on or off. Pressing and holding this key turns the backlight on or off permanently. Normally, the backlight turns on for eight seconds any time a key is pressed. The backlight provides more light to the display. Decreases or increases a parameter. The patient programmer must be held over the neurostimulator while pressing the Increase key or Decrease key. Pressing and holding the key changes the parameter every halfsecond. To increase a parameter, the neurostimulator must be turned on. Use the Sync key to synchronize your neurostimulator and patient programmer (Figure 4.7). 66 English

67 Sync key Figure 4.7 Sync key. Synchronizing sends the settings from your neurostimulator to the patient programmer. All communication with the neurostimulator begins with synchronization. After synchronization, the Therapy screen appears. To synchronize your neurostimulator and the patient programmer, hold the patient programmer over your neurostimulator and press the Sync key. After synchronization, the Therapy screen appears. Using your patient programmer English 67

68 Using the Navigator key Use the Navigator key (Figure 4.8) to navigate between and across the rows on the Therapy screen. Using your patient programmer 4 Figure 4.8 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 icon will appear next to the selection box (Figure 4.9). 68 English

69 Selection box Options icon Figure 4.9 Options icon and selection box. The Navigator key moves the selection box. The arrows on the Navigator key indicate the direction the selection box will move. To move the selection box between rows, press the up and down arrows on the Navigator key. To move the selection box across a row that continues, press the left and right arrows on the Navigator key. When moving the selection box with the Navigator key, you do not need to hold the programmer over your neurostimulator. However, you must hold the patient programmer over your neurostimulator when pressing all other keys except the Power/Backlight key. Using your patient programmer English 69

70 Using your patient programmer 4 Turning your neurostimulator on or off Complete the following steps to turn the neurostimulator on or off. Note: Turning your neurostimulator on or off also synchronizes the patient programmer and neurostimulator. 1. Hold the patient programmer over your neurostimulator with the patient programmer screen facing outward and press the Neurostimulator on or Neurostimulator off key (Figure 4.10). 2. Verify that the appropriate On or Off icon is displayed on the Therapy screen (Figure 4.10). 70 English

71 On Off Figure 4.10 Turning your neurostimulator on or off. Caution: To prevent possible uncomfortable or unexpected stimulation (jolting or shocking sensation) when stimulation is turned on, decrease all amplitudes to the lowest setting before adjusting the pulse width 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 "Increasing or decreasing a parameter (amplitude, pulse width, or rate)" on page 104. Using your patient programmer English 71

72 How to maintain the neurostimulator batteries It is very important that you maintain your neurostimulator batteries, whether you have an external, an implanted rechargeable, or an implanted non-rechargeable neurostimulator. Though you will not need to recharge the external or non-rechargeable neurostimulators, you should check the battery status regularly and report any low battery messages to your clinician. Using your patient programmer 4 Checking the external neurostimulator battery Check the external neurostimulator battery level every day. Complete the following steps to check the external neurostimulator battery. 1. Synchronize the patient programmer and neurostimulator. 72 English

73 a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. 2. Review the external neurostimulator battery level on the Therapy screen (Figure 4.11). Battery level Replace batteries Full Figure 4.11 External neurostimulator battery status. Table 4.5 lists the message screens associated with the external neurostimulator batteries. Using your patient programmer English 73

74 Table 4.5 External neurostimulator battery message screens Using your patient programmer 4 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. 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. Press any arrow on the Navigator key to clear this information screen. Checking the implanted rechargeable neurostimulator battery (Models 37711, 37712, 37713, 37714, 97712, 97713, 97714) 74 English

75 Note: This section applies only to a neurostimulator with a rechargeable battery. If your neurostimulator is nonrechargeable, continue with "Checking the implanted nonrechargeable neurostimulator battery". Check the implanted rechargeable neurostimulator battery charge level every day. It is critical that you charge your neurostimulator battery before the battery is overdischarged. Refer to the manual packaged with the charging system for more information. Caution: Charge the neurostimulator when you see a Low battery ( ) screen displayed 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 Using your patient programmer English 75

76 Using your patient programmer 4 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. Complete the following steps to check the implanted rechargeable neurostimulator battery. 76 English

77 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. 2. Review the implanted rechargeable battery charge level on the Therapy screen (Figure 4.12). Battery charge level Charge neurostimulator Full Figure 4.12 Implanted neurostimulator charge level on the Therapy screen. Table 4.6 on page 78 lists the message screens associated with the implanted rechargeable neurostimulator battery charge level. Using your patient programmer English 77

78 When the implanted rechargeable neurostimulator battery charge level is low, charge the battery as described in the manual packaged with the charging system. Your implanted rechargeable neurostimulator battery can be charged many times; however, eventually the implanted rechargeable neurostimulator will need to be replaced. Table 4.6 Implanted rechargeable neurostimulator battery message screens Using your patient programmer 4 The implanted rechargeable neurostimulator battery charge level is low and stimulation has stopped. Charge the neurostimulator battery now. Refer to the manual packaged with the charging system. The implanted rechargeable neurostimulator battery charge level is low and stimulation will not be available soon. Charge the neurostimulator battery. Refer to the manual packaged with the charging system. Press any arrow on the Navigator key to clear this information screen. 78 English

79 Checking the implanted nonrechargeable neurostimulator battery (Models 37701, 37702, 37703, 37704, 97702) Complete the following steps to check the implanted nonrechargeable neurostimulator battery. 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. 2. Review the battery status on the Therapy screen. Table 4.7 lists the message screens associated with the implanted nonrechargeable neurostimulator battery. Using your patient programmer English 79

80 When the battery in an implanted nonrechargeable neurostimulator is nearing depletion, the neurostimulator must be replaced to continue receiving stimulation. Surgery is required to replace the implanted nonrechargeable neurostimulator. Table 4.7 Implanted nonrechargeable neurostimulator battery message screens Using your patient programmer 4 EOS Error code = EOS: The implanted nonrechargeable neurostimulator has reached its end of service. Stimulation is not available. Call your clinician. Error code = ERI: The implanted nonrechargeable neurostimulator is nearing end of service. Stimulation will not be available soon. Call your clinician to report this message screen. Press any arrow on the Navigator key to clear this information screen. This screen reappears daily. After clearing this screen, a low battery level icon appears on the Status row of the Therapy screen. 80 English

81 Changing patient programmer preferences Patient programmer preferences affect the way information displays on the screen or the way alert tones sound. These patient programmer preferences include audio, contrast, time, time/number format, and group name. Other features can also be accessed from preference settings. Table 4.8 lists the icons associated with the preference settings and where to find information on other features. Table 4.8 Preference settings icons Icons Preference Audio Contrast Time Time and number format Group name display Using your patient programmer English 81

82 Table 4.8 Preference settings icons (continued) Icons Abc Preference AdaptiveStim name display Return to clinician settings a (see page 108) AdaptiveStim enabled a (see page 129) a Changing these preferences will change your stimulation settings. Complete the following steps to change patient programmer preferences. Using your patient programmer 4 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. 82 English

83 2. Press the up arrow on the Navigator key to move the selection box to the Status row (Figure 4.13). Status row Figure 4.13 Accessing preferences from the Status row. 3. Press the left or right arrow on the Navigator key to move the selection box to the desired preference (Figure 4.14). Figure 4.14 Moving to the desired preference. 4. Press the down arrow to move the selection box to the Change row (Figure 4.15). Using your patient programmer English 83

84 Change row Figure 4.15 Changing the desired preference from the change row. 5. Follow the steps in Table 4.9 to change the selected preference. Table 4.9 Changing patient programmer preferences Using your patient programmer 4 Audio 1. Press the left or right arrow on the Navigator key to move the selection box to audio on or off. 2. Go to step 6, page English

85 Table 4.9 Changing patient programmer preferences (continued) Contrast 1. Press the left or right arrow on the Navigator key to make the contrast lighter or darker. 2. Go to step 6, page 88. Using your patient programmer English 85

86 Table 4.9 Changing patient programmer preferences (continued) Using your patient programmer 4 Time 1. Press the left or right arrow on the Navigator key to move the selection box to the hour, minutes, or time of day (A or P). 2. Press the Increase or Decrease key to change the selection. 3. Press the up arrow on the Navigator key to return the selection box to the Status row. 4. Press the left or right arrow on the Navigator key to return to the Therapy screen. 5. Press the Sync key to send the change to your neurostimulator. 6. To verify the time change, repeat steps 2 and 3 on page 83 to return to the Time Preference screen. 86 English

87 Table 4.9 Changing patient programmer preferences (continued) Time and number format 1. Press the left or right arrow on the Navigator key to move the selection box to a 12-hour clock and numbers with decimals or a 24-hour clock and numbers with commas. 2. Go to step 6, page 88. Group name display (Refer to page 114 for more information about group names.) 1. Press the left or right arrow on the Navigator key to move the selection box to one of the following: icons ( ), letters ( ), or text ( ). 2. Go to step 6, page 88. Using your patient programmer English 87

88 Table 4.9 Changing patient programmer preferences (continued) Using your patient programmer 4 Abc AdaptiveStim name display (Refer to page 126 for more information about AdaptiveStim names.) 1. Press the left or right arrow on the Navigator key to move the selection box to one of the following: English, French, German, Italian, Spanish, or AdaptiveStim icon only. 2. Go to step 6, page When the change is displayed on the screen, move the selection box to the Status row. 88 English

89 Note: The preference change is sent to the neurostimulator at the next synchronization. 7. Press the left or right arrow on the Navigator key to move to another preference or return to the Therapy screen. 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 4.16). The case also has a loop on the back that attaches to a belt. Using your patient programmer English 89

90 Figure 4.16 Insert the patient programmer into the case. Place an identification label on the back of your patient programmer in case the patient programmer is lost (Figure 4.17). Using your patient programmer 4 ID label Figure 4.17 Place the adhesive label on the back of the patient programmer. 90 English

91 Using the detachable antenna A detachable antenna (Model 37092) is available if you have difficulty reaching the neurostimulator. It is also useful for viewing the patient programmer screen while you are adjusting stimulation. Complete the following steps to use the detachable antenna. 1. Place the antenna over your neurostimulator (Figure 4.18). Figure 4.18 Place the antenna over your neurostimulator. Using your patient programmer English 91

92 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 4.19). a b Using your patient programmer 4 Figure 4.19 Pull the fabric through the slit (a) and wedge in place (b). 3. Push the antenna plug firmly into the antenna jack ( ) on the patient programmer (Figure 4.20). 92 English

93 Figure 4.20 Insert the antenna plug into the antenna jack. 4. After the antenna is connected, follow the instructions for using the patient programmer. 5. When you have finished using the patient programmer, grasp the antenna plug and pull it out. Using your patient programmer English 93

94 Caution: Do not pull directly on the antenna cable to disconnect the cable from the programmer because this may damage the antenna cable. Using your patient programmer 4 94 English

95 5 Adjusting your stimulation

96 Adjusting your stimulation 5 Introduction Various features are available for adjusting your stimulation. Each type or model of neurostimulator provides a unique set of stimulation features. Stimulation features Using the basic neurostimulation features, you can adjust the rate, amplitude, and pulse width settings for your stimulation. For complete information, see "Increasing or decreasing a parameter (amplitude, pulse width, or rate)" on page 104. For information about other stimulation features and which neurostimulators support these features, refer to Table 5.1 on page English

97 Table 5.1 Stimulation features available for neurostimulator models a Model Groups Clinician Scheduled settings b therapy Group Adjust Target MyStim Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Adaptive Stim Adjusting your stimulation English 97

98 Adjusting your stimulation 5 Table 5.1 Stimulation features available for neurostimulator models a Model Groups Clinician Scheduled settings b therapy Group Adjust Target MyStim Adaptive Stim a Neurostimulator models and do not provide the stimulation features listed in this table. b This feature, "Changing back to clinician settings," allows you to change your stimulation settings back to those previously set by your clinician. 98 English

99 Notes: See "Viewing and changing a group" for more information about Groups and "Using GroupAdjust" for more information about GroupAdjust. See "Using TargetMyStim" for more information about TargetMyStim. Adjusting stimulation settings 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 programmed stimulation option to another, and adjust the amplitude, pulse width, or rate of the stimulation. Talk to your clinician about the settings that apply to your therapy. Your clinician programs the available functions and specifies the settings you can adjust with your patient programmer. Discuss this with your clinician. Adjusting your stimulation English 99

100 Adjusting your stimulation 5 There is often more than one way to change stimulation settings. These instructions describe the most common ways. Notes: Ask your clinician to print a report with your programmed settings. When a stimulation setting is changed, you will see the change on the Therapy screen. If the patient programmer audio is turned on, you will hear 1 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. 100 English

101 Table 5.2 provides general guidelines for adjusting your stimulation. For additional adjustment guidelines refer to the sections on the specific features associated with your neurostimulator. Adjusting your stimulation English 101

102 Table 5.2 General stimulation adjustment guidelines Adjusting your stimulation 5 Situation Stimulation is too strong Stimulation is not strong enough Stimulation covers too much area Stimulation does not cover painful area The pulses (tapping sensations) feel too slow The pulses (tapping sensations) feel too fast Action Decrease amplitude(s) or pulse width(s) Increase amplitude(s) or pulse width(s) Decrease amplitude(s) or pulse width(s) or change to a different group Increase amplitude(s) or pulse width(s) or change to a different group Increase rate Decrease rate 102 English

103 Table 5.2 General 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 Contact your clinician. stimulation but are unable to find an effective setting. 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. Adjusting your stimulation English 103

104 Adjusting your stimulation 5 Increasing or decreasing a parameter (amplitude, pulse width, or rate) Complete the following steps to adjust a parameter. Notes: To increase a parameter, the neurostimulator must be on. To decrease a parameter, the neurostimulator may be on or off. 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. Caution: To prevent possible uncomfortable or unexpected stimulation (jolting or shocking sensation) when stimulation is turned 104 English

105 on, decrease all amplitudes to the lowest setting before adjusting the pulse width or rate and after turning off the neurostimulator. 2. Verify that the group is active ( ) and that the selection box is located on the Parameter row. 3. Press the left or right arrow on the Navigator key to move the selection box to the desired parameter and program (Figure 5.1). Figure 5.1 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 ( ) for each program, followed by the pulse Adjusting your stimulation English 105

106 Adjusting your stimulation 5 width ( ) for each program, and then the rate ( ). (Scrolling to the left reverses the order.) The program is designated by the number above the Amplitude or Pulse width icon. There will not be a number above the Rate icon because the rate is the same for all programs in a group. 4. Hold the patient programmer over your neurostimulator and press the Increase or Decrease key as needed. The increase or decrease occurs immediately and is saved in the neurostimulator. Notes: Pressing and holding the Increase or Decrease key changes the value every half-second. If one of the information screens in Table 5.3 appears, you tried to increase or decrease the parameter beyond the limits programmed by your 106 English

107 clinician or beyond the capabilities of your neurostimulator. Table 5.3 Parameter limit screens You tried to decrease a parameter below the lowest value allowed (lower limit). Press any arrow on the Navigator key to clear the information screen. You tried to increase a parameter above the highest value allowed (upper limit). Press any arrow on the Navigator key to clear the information screen. Adjusting your stimulation English 107

108 Table 5.3 Parameter limit screens (continued) You tried to increase a parameter above what your neurostimulator can deliver. Press any arrow on the Navigator key to clear the information screen. Changing back to clinician settings (Models 37022, 37702, 37712, 37713, 37714, 97702, 97712, 97713, 97714) Adjusting your stimulation 5 You can change the stimulation settings back to the original settings programmed by your clinician. Complete the following steps to change back to clinician settings. Note: Clinician settings will be applied to the group that is active. If your neurostimulator 108 English

109 supports the use of groups, verify that the group you want to change back to clinician settings is active (see "Viewing and changing a group" on page 111 for instructions on selecting a group). 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. 2. Press the up arrow on the Navigator key to move the selection box to the Status row (Figure 5.2). Status row Figure 5.2 Accessing preferences from the Status row. Adjusting your stimulation English 109

110 3. Press the left or right arrows on the Navigator key to move the selection box to the Return to Clinician Settings preference (Figure 5.3). 4. Press the down arrow to move the selection box to the Change row (Figure 5.3). Change row Adjusting your stimulation 5 Figure 5.3 Change row for selected preference. 5. Press the Sync key to send the change to your neurostimulator and return to the Therapy screen. 110 English

111 Viewing and changing a group (Models 37022, 37701, 37702, 37711, 37712, 37713, 37714, 97702, 97712, 97713, 97714) If your clinician programs the Group function, you may be able to change stimulation settings by selecting a different group. Also, if the Group Name function is enabled, you will see the active group displayed on your programmer screen, see "Displaying group names" on page 114 for more information on how to change how the active group is displayed. Complete the following steps to change to a new group and make the new group active. 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. Adjusting your stimulation English 111

112 b. Press the Sync key. The Therapy screen appears. 2. If needed, press the up arrow on the Navigator key to move the selection box to the Group row (Figure 5.4). Group row Adjusting your stimulation 5 Figure 5.4 Group row on the Therapy screen. 3. Press the left or right arrows on the Navigator key to move the selection box to the new, inactive group (Figure 5.5). 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. 112 English

113 Figure 5.5 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 5.6). 5. Verify that the new group is active on the Therapy screen (Figure 5.6). Figure 5.6 Making a group active. Adjusting your stimulation English 113

114 Displaying group names (Models 37022, 37702, 37712, 37713, 97702, 97712, 97713) Your clinician may enable the Group Name function to specify the groups for you to use for specific areas of coverage, activity, or times. The group name displayed on the patient programmer screen can be a letter (eg, A), an icon (eg, ), or text (eg, Walk). Use the definitions listed in Table 5.4 to understand the icon or text displayed on your patient programmer. Table 5.4 Group name (icons/text) Adjusting your stimulation 5 Icon Text a Definition Sit Group for sitting Stand Group for standing Lie Group for lying Walk Group for walking Sleep Group for sleeping Write Group for writing 114 English

115 Table 5.4 Group name (icons/text) (continued) Icon Text a Definition Day Night Back L Leg R Leg Legs L Arm R Arm Arms Hand Foot Group for daytime Group for nighttime Group for back pain Group for left leg pain Group for right leg pain Group for leg pain Group for left arm pain Group for right arm pain Group for arm pain Group for hand pain Group for foot pain a The text listed in this column will be displayed on the patient programmer exactly as shown in this column (ie, the text will not be translated from English into local languages). Adjusting your stimulation English 115

116 Using GroupAdjust (Models 37022, 37702, 37712, 37713, 37714, 97702, 97712, 97713, 97714) If your clinician enabled the GroupAdjust function, the GroupAdjust icon ( ) will appear in the Parameter row (Figure 5.7). GroupAdjust can be used to adjust all the program amplitudes for the active group at the same time. Parameter row A Adjusting your stimulation 5 Figure 5.7 GroupAdjust on the Parameter row. When the Increase key or Decrease key is selected, the GroupAdjust screen is displayed (Figure 5.8). Figure 5.8 GroupAdjust screen. 116 English

117 Each bar on the GroupAdjust screen represents a program amplitude in the active group. The highlighted portion of the bar represents how much you can adjust the program amplitude before reaching the limits programmed by your clinician. The highlighted portion of the bar increases or decreases as you increase or decrease the amplitude. Complete the following steps to use GroupAdjust to change program amplitudes. Notes: To increase the amplitude, the neurostimulator must be on. To decrease the amplitude, the neurostimulator may be on or off. 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. Adjusting your stimulation English 117

118 Adjusting your stimulation 5 b. Press the Sync key. The Therapy screen appears. 2. Verify that the group is active ( ) and the selection box is located on the GroupAdjust icon on the Parameter row (Figure 5.7 on page 116). 3. Hold the patient programmer over your neurostimulator and press the Increase or Decrease key. The GroupAdjust screen appears. 4. Hold the patient programmer over your neurostimulator and press the Increase or Decrease key to increase or decrease the amplitude as needed. 5. Once the desired levels are displayed, release the Increase or Decrease 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 118 English

119 upper or lower limit before the other program amplitudes. The program that reaches its upper or lower limit will stop increasing or decreasing while the other programs continue increasing or decreasing until they reach their limits. When all programs in the group have reached their upper or lower limits, an information screen will indicate that the limit has been reached (refer to Table 5.3 on page 107). Viewing Scheduled Therapy (Models 37022, 37701, 37702, 37711, 37712, 37713, 97702, 97712, 97713) If your clinician programmed Scheduled Therapy, the Scheduled Therapy icon ( ) appears in the Group row. Scheduled Therapy allows your clinician to program therapy for a specific time of day. You can view Scheduled Therapy status from the Therapy screen. Adjusting your stimulation English 119

120 An example of Scheduled Therapy is provided in Figure 5.9. 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 Group B is active Adjusting your stimulation 5 Figure 5.9 Example of Scheduled Therapy. Note: You can still change groups or turn your neurostimulator on or off when Scheduled Therapy is programmed. 120 English

121 Using TargetMyStim (Models 37022, 37702, 37712, 37713, 37714, 97702, 97712, 97713, 97714) If your clinician has programmed TargetMyStim, the TargetMyStim icon ( 1) will appear in the Parameter row (Figure 5.10). TargetMyStim allows you to make adjustments to your therapy by moving the lead array (active electrodes) up or down one level. Parameter row 1 3 / 5 Figure 5.10 TargetMyStim on Parameter row. Note: If you have a Model or neurostimulator and are using AdaptiveStim, TargetMyStim is not available for AdaptiveStim groups (refer to page 124 for more information on AdaptiveStim). The small metal electrodes near the tip of the lead are not all active at the same time. Only Adjusting your stimulation English 121

122 Adjusting your stimulation 5 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 small numbers on the TargetMyStim icon represent the electrode position for a program in the active group and the number of adjustments available (Figure 5.10). 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 key or Decrease key is selected, the TargetMyStim screen is displayed showing the current position and the selected position (Figure 5.11). 122 English

123 1 3/5 4/5 Figure 5.11 TargetMyStim screen. Complete the following steps to use TargetMyStim to adjust your stimulation. 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. 2. Verify that the group is active ( ) and the selection box is located on the TargetMyStim icon on the Parameter row (Figure 5.10 on page 121). 3. Hold the patient programmer over your neurostimulator and press the Increase Adjusting your stimulation English 123

124 Adjusting your stimulation 5 or Decrease key. The TargetMyStim screen appears. 4. Hold the patient programmer over your neurostimulator and press the Increase or Decrease key to change active electrode positions as needed. 5. Once the desired levels are displayed, press the Sync key. The patient programmer changes the electrode position, then the amplitude slowly increases until it reaches the programmed value. Pressing the Increase or Decrease 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. Using AdaptiveStim (Models 37714, 97714) If your clinician has programmed AdaptiveStim and AdaptiveStim is turned on, 124 English

125 the AdaptiveStim icon ( ) will appear next to the Neurostimulator on icon ( ) in the Status row (Figure 5.12). Note: Your neurostimulator must be turned on ( ) to view AdaptiveStim settings. Status row A B Lying B Figure 5.12 AdaptiveStim icon on Status row of Therapy screen. When your clinician has programmed AdaptiveStim, the neurostimulator records your amplitude adjustments and your changes in position. As you make amplitude adjustments, the new amplitude settings are assigned to the position. The next time you return to this position, the stimulation will match what you selected the last time you were in this position. Note: There may be a short delay before the stimulation changes in response to your Adjusting your stimulation English 125

126 change in position. This delay keeps the neurostimulator from making unnecessary adjustments based on temporary changes in your position. Your clinician can adjust the length of this delay. Adjusting your stimulation 5 AdaptiveStim groups and positions Your clinician can program specific amplitudes for each of 6 positions or your clinician can program AdaptiveStim to adapt the amplitude settings based on the adjustments you make to your stimulation while in one of the positions. AdaptiveStim recognizes these 6 positions: Standing or sitting still Lying on your back or face up Lying on your front or face down Lying on your right side Lying on your left side Mobile 126 English

127 AdaptiveStim position names (abbreviated text or the AdaptiveStim icon) are displayed on the Group row of the Therapy screen. AdaptiveStim position icons are displayed on the Parameter row (Figure 5.13). A Group row Parameter row B Lying B Figure 5.13 AdaptiveStim positions. The AdaptiveStim position displayed on the Therapy screen indicates the position you were in the last time your patient programmer communicated with your neurostimulator. This means that the AdaptiveStim position and stimulation settings displayed on the Therapy screen may not be your current position or the settings currently in use by your neurostimulator. You must synchronize the patient programmer and neurostimulator (refer to "Using the Sync key" on page 66) to display Adjusting your stimulation English 127

128 your current position and the stimulation settings currently in use by the neurostimulator. Note: AdaptiveStim does not recognize reclining positions. The Therapy screen will display your starting position before reclining. For example, when changing to a reclining position from a standing position, the Therapy screen will reflect Upright or. When changing to a reclining position from lying on your back, the Therapy screen will reflect Lying B or. Use the definitions listed in Table 5.5 to understand the AdaptiveStim position names and icons on the Therapy screen. Adjusting your stimulation 5 Table 5.5 AdaptiveStim positions on the Therapy screen Group row a Upright or Lying B or Parameter row Position description Standing or sitting upright Lying on your back 128 English

129 Table 5.5 AdaptiveStim positions on the Therapy screen (continued) Group row a Lying F or Lying R or Lying L or Mobile or Parameter row Position description Lying on your front Lying on your right side Lying on your left side Mobile while upright Transitioning between positions a The text listed in this column will be displayed on the patient programmer in the language selected from the AdaptiveStim name display preference (ie, the text may be in another language other than English) Turning AdaptiveStim on and off If AdaptiveStim is turned on, the AdaptiveStim icon ( ) will appear next to the Neurostimulator on icon ( ) in the Status row. Adjusting your stimulation English 129

130 Note: Your neurostimulator must be turned on ( ) to view AdaptiveStim settings. Complete the following steps to turn AdaptiveStim on or off. 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. 2. Press the up arrow on the Navigator key to move the selection box to the Status row (Figure 5.14). Adjusting your stimulation 5 Status row Figure 5.14 Accessing preferences from the Status row. 130 English

131 3. Press the left or right arrows on the Navigator key to move the selection box to the AdaptiveStim preference (Figure 5.15). Note: The preference screen displays the AdaptiveStim state that you will change to. For example, if AdaptiveStim is currently turned on, the AdaptiveStim off icon (shown in Figure 5.15) will be displayed on the preference screen. A AdaptiveStim off icon showing Figure 5.15 AdaptiveStim preference screen. 4. Press the Sync key to send the change to your neurostimulator and return to the Therapy screen. Adjusting your stimulation English 131

132 Adjusting your stimulation 5 Making adjustments to AdaptiveStim If you make an adjustment to your stimulation and want to have that adjustment remembered for your current position, you must make the adjustment and stay in your current position for at least 3 minutes. Note: If you change position while increasing or decreasing your stimulation amplitude, the AdaptiveStim icon or text will blink, indicating the patient programmer has updated to the current AdaptiveStim position. Even with AdaptiveStim enabled, you may need to make adjustments to your stimulation. Table 5.6 provides general guidelines for adjusting your stimulation when using AdaptiveStim. 132 English

133 Table 5.6 AdaptiveStim adjustment guidelines Situation AdaptiveStim stimulation for a specific position is uncomfortable. You are unable to adjust AdaptiveStim stimulation while in a specific position. Stimulation becomes uncomfortable while riding in a car or another type of transportation. Stimulation becomes uncomfortable while moving in an elevator, escalator, etc. You want AdaptiveStim to turn your therapy off when in a certain position. Action While in the applicable position, decrease amplitude(s) and remain in that position for at least 3 minutes. Make the desired stimulation adjustment, then get in the desired position within 3 minutes and stay there for at least three minutes. Turn AdaptiveStim off. Turn AdaptiveStim off. Adjust your amplitude to 0 V to turn your therapy off instead of turning the neurostimulator off. Adjusting your stimulation English 133

134 Adjusting your stimulation English

135 6 MRI examinations

136 If you have an MRI appointment Depending on what kind of neurostimulation system components that you have implanted, you may be eligible for one of the following types of magnetic resonance imaging (MRI) scans: MRI scans of the head only (this is referred to as head-only eligible). MRI scans of any part of your body (this is referred to as full-body eligible). MRI examinations 6 Responsibilities of the patient in preparing for the MRI appointment If you have a patient identification (ID) card given to you by Medtronic for your implanted neurostimulation system, be sure to bring your most current card to every MRI appointment. The patient ID card shows the MRI clinician that Medtronic is the manufacturer of your implanted 136 English

137 neurostimulation system. The patient ID card also identifies your neurostimulator model number. The MRI clinician can use this information to obtain instructions to determine the eligibility of your implanted neurostimulation system for the MRI scan and the MRI scan safety conditions required by your neurostimulation system. Bring the MRI scan eligibility sheet to the MRI appointment if you were given one from your clinician managing your neurostimulation system. Bring your patient programmer to every MRI appointment. However, do not take the patient programmer into the MRI scanner (magnet) room. At the MRI appointment If you have a patient identification (ID) card given to you by Medtronic for your implanted neurostimulation system, MRI examinations English 137

138 MRI examinations 6 present your most current card to the MRI clinician. Be sure to inform the MRI clinician that you have an implanted neurostimulation system for chronic pain. If you no longer have an implanted neurostimulator, be sure to inform the MRI clinician of any leads or other components that still remain implanted. To obtain the MRI guidelines, the MRI clinician can refer to the contact information at the back of this manual, or the MRI clinician can go to Warning: Inform the MRI clinician before you enter the MRI scanner (magnet) room that you have an implanted neurostimulation system. If you do not provide this important information, you may be given an inappropriate MRI scan, which could cause you injury or could cause damage to your implanted medical device. The MRI clinician conducting your 138 English

139 MRI scan needs to be aware of all medical implants in order to assess the conditions for safely performing your MRI scan. Placing your neurostimulation system in MRI mode for the MRI scan Your implanted neurostimulation system must be placed in MRI mode before your MRI scan. MRI mode turns stimulation off. MRI mode can be activated with your Model patient programmer or with a clinician programmer (if you have a neurostimulator with SureScan MRI Technology). Table 6.1 shows where to go in this chapter for more information. MRI examinations English 139

140 Table 6.1 Activating MRI mode With a patient programmer With a clinician programmer See "Using the Model patient programmer to activate MRI mode" on page 140. See "For neurostimulators with SureScan MRI Technology (Models 97702, 97712, 97713, 97714)" on page 152. MRI examinations 6 Using the Model patient programmer to activate MRI mode If you brought your Model patient programmer to the MRI appointment, you can place your neurostimulation system in MRI mode before your MRI scan and outside of the MRI scanner (magnet) room. MRI mode turns stimulation off. When you activate MRI mode with your patient programmer, stimulation is turned off and an MRI scan eligibility screen will appear. Show this screen to the MRI clinician. 140 English

141 During the MRI scan, keep your neurostimulation system in MRI mode (stimulation must remain off). After the MRI scan and outside of the MRI scanner (magnet) room, you can turn stimulation back on using your patient programmer or you can return to the clinician managing your neurostimulation system to have stimulation turned back on. Activating MRI mode Complete the following steps to activate MRI mode. 1. Synchronize the patient programmer and the neurostimulator. a. Hold the patient programmer directly over your neurostimulator with the screen facing outward. b. Press the Sync key (Figure 6.1). The Therapy screen appears (Figure 6.2 on page 143). MRI examinations English 141

142 Sync key Navigator key Figure 6.1 Location of the Sync key and Navigator key. Note: If the patient programmer does not synchronize the first time, try again with the programmer repositioned over the neurostimulator. 2. If needed, press the up arrow on the Navigator key to move the selection box to the Status (top) row (Figure 6.2). MRI examinations English

143 Status (top) row Therapy screen Selection box on bottom row Therapy screen Move selection box to top row Figure 6.2 Move the selection box to the top row. 3. Press the left or right arrows on the Navigator key to move the selection box until the following screen appears: MR Conditional symbol Sync icon Figure 6.3 The MRI mode activation screen. 4. Hold the patient programmer directly over your neurostimulator with the screen facing outward and press the Sync MRI examinations English 143

144 MRI examinations 6 key. Do not press any other key afterwards. When MRI mode is activated, your implanted neurostimulation system has been placed in MRI mode and stimulation is turned off. Caution: Do not turn stimulation back on before your MRI scan. Leaving stimulation on during the scan could increase the potential for uncomfortable, unintended stimulation. In addition, one of three screens will appear showing the MRI scan eligibility for your implanted neurostimulation system (Figure 6.4). The display of the MRI scan eligibility screen confirms that your neurostimulation system has been placed in MRI mode and stimulation has been turned off. 144 English

145 Serial number of implanted neurostimulator Model number of implanted neurostimulator Information code for MRI clinician to use when contacting Medtronic Technical Support Figure 6.4 Examples of MRI scan eligibility screens. MRI examinations English 145

146 Table 6.2 MRI scan eligibility icons MRI examinations 6 Icon or icon combination Explanation Full-body scan eligible The implanted neurostimulation system allows the patient to be eligible to have MRI scans of any part of the body under specific conditions. The MRI clinician must consult the MRI guidelines for those conditions. Head scan eligible with transmit/ receive head coil The implanted neurostimulation system allows the patient to be eligible for MRI scans of the head only using an RF transmit/receive head coil and under other specific conditions. The MRI clinician must consult the MRI guidelines for those conditions. 146 English

147 Table 6.2 MRI scan eligibility icons (continued) Icon or icon combination Explanation The neurostimulation system MRI scan eligibility cannot be determined. The MRI clinician must consult the MRI guidelines to determine how to proceed or contact Medtronic Technical Support. Information code The code for the MRI clinician to give when contacting Medtronic Technical Support to gather further information about your implanted neurostimulation system. 5. Do not press any other key. Note: The MRI scan eligibility screen on the patient programmer will display for 20 minutes. The buttons on the front of the programmer are disabled when in MRI mode to allow the MRI clinician to MRI examinations English 147

148 MRI examinations 6 photocopy the MRI scan eligibility screen if needed. 6. Give the patient programmer to the MRI clinician with the MRI scan eligibility screen displayed. Note: Do not take the patient programmer into the MRI scanner (magnet) room. If you brought the recharger with you to the MRI appointment, do not take the recharger into the MRI scanner (magnet) room either. Turning stimulation back on after the MRI scan Turn stimulation back on when the MRI scan is complete and you are outside of the MRI scanner (magnet) room. Turning stimulation back on deactivates MRI mode. Stimulation can be turned on with the patient programmer or the clinician programmer: 148 English

149 If you do not have your patient programmer with you, go to the clinician managing your neurostimulation system to turn stimulation on using the clinician programmer. If you brought your patient programmer to the MRI appointment, turn stimulation back on using the patient programmer (see the steps that follow). Complete the following steps to turn on stimulation using the patient programmer. 1. Hold the patient programmer directly over your neurostimulator with the screen facing outward and press the Sync key. 2. Hold the patient programmer over your neurostimulator with the patient programmer screen facing outward and press the Neurostimulator on key (Figure 6.5). MRI examinations English 149

150 Neurostimulator on key Figure 6.5 Neurostimulator on key. 3. Verify that the Neurostimulator on icon ( ) is displayed on the Status row of the Therapy screen. MRI mode is deactivated when the Therapy screen displays with the Neurostimulator on icon (Figure 6.6). MRI examinations English

151 Neurostimulator on icon Therapy screen Figure 6.6 The Therapy screen displays with the Neurostimulator on icon when MRI mode is deactivated. Note: If a power-on-reset (POR) screen appears on the patient programmer, see Table 6.3. Table 6.3 POR screens Screen POR Call your clinician Cause and action Error code = POR: Stimulation has stopped. Call your clinician to restart your therapy. MRI examinations English 151

152 Table 6.3 POR screens (continued) Screen POR Reset occurred Cause and action The implanted neurostimulator has been reset. Stimulation is not available. Call your clinician to report this message screen. To clear the information screen, press any arrow on the Navigator key. For neurostimulators with SureScan MRI Technology (Models 97702, 97712, 97713, 97714) Note: The model number for your implanted neurostimulator is on your patient ID card. MRI examinations 6 If you have a neurostimulator with SureScan MRI Technology, the clinician managing your neurostimulation system can place your neurostimulation system in MRI mode for your MRI examination using the clinician programmer. 152 English

153 You may need to inform your clinician managing your neurostimulation system that an MRI examination has been prescribed for you and that you need MRI mode activated. MRI mode turns stimulation off. Do not turn stimulation back on before your MRI scan. Caution: Do not turn stimulation back on before your MRI scan. Leaving stimulation on during the scan could increase the potential for uncomfortable, unintended stimulation. The clinician may give you an MRI scan eligibility sheet to bring to your MRI appointment. Give the eligibility sheet to the MRI clinician. During the MRI scan, keep your neurostimulation system in MRI mode (stimulation must remain off). After the MRI scan and outside of the MRI scanner (magnet) room, you can turn stimulation back on using your patient programmer or you can return to the clinician MRI examinations English 153

154 managing your neurostimulation system to have stimulation turned back on. MRI examinations English

155 7 Maintenance

156 This section describes how to care for and dispose of your patient programmer and accessories. Patient programmer batteries Always keep 2 new AAA alkaline batteries available for replacement. New batteries provide about 2 months of use, depending upon how often the programmer is used. 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. Maintenance 7 Checking the patient programmer batteries You can check the patient programmer batteries at any time. Complete the following steps to check the patient programmer batteries. 1. Synchronize the patient programmer and neurostimulator. 156 English

157 a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. 2. Review the patient programmer battery status and battery level. The Therapy screen displays an icon indicating the patient programmer battery level (Figure 7.1). Battery level Replace batteries Full Figure 7.1 Patient programmer battery level on the Therapy screen. Table 7.1 lists the screens associated with the patient programmer battery. Maintenance English 157

158 Table 7.1 Patient programmer battery screens The patient programmer batteries are depleted. Programming is not possible. Replace the patient programmer batteries now. The patient programmer batteries are low. You can finish programming. Replace the patient programmer batteries before the batteries become depleted. Press any arrow on the Navigator key to clear the information screen. Replacing the patient programmer batteries 1. Open the battery compartment cover (Figure 7.2). Maintenance English

159 Figure 7.2 Opening the battery cover. 2. Remove the depleted batteries. 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. Maintenance English 159

160 Maintenance 7 Cleaning and care Follow these guidelines to ensure that the patient programmer and accessories function properly. 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. Follow all warnings and precautions in Chapter 2 "Important therapy information" and Chapter 11 "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. 160 English

161 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. 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. Refer to the Medtronic contacts at the end of this manual. Maintenance English 161

162 Battery and patient programmer disposal Dispose of depleted batteries and worn out devices according to local requirements. If you no longer need your patient programmer and would like to donate it, contact your clinician. 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. Maintenance English

163 Specifications Table 7.2 Patient programmer specifications Item Power source Specification 2 AAA alkaline batteries (nonrechargeable, LR03) Operating temperature 9 C to 43 C (49 F to 110 F) Storage temperature -34 C to 57 C Size (approximate) Weight, including batteries (approximate) Battery life Mode of operation (-30 F to 135 F) 9.4 cm 5.6 cm 2.8 cm (3.7 in 2.2 in 1.1 in) 111 g (3.9 oz) 2 months (average) for alkaline batteries Continuous Maintenance English 163

164 Table 7.3 Implanted neurostimulation system specifications Description Typical materials in contact with human tissue a Neurostimulator Lead Extension Specifications Titanium Polyurethane Silicone rubber Silicone medical adhesive Polysulfone Polyurethane Platinum iridium Polyurethane a For a complete list of materials in contact with human tissue, contact your clinician. Maintenance English

165 8 Troubleshooting

166 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 ( ), information ( ), and communication ( ) screens to provide you with information about your system, alert you to a problem with your system, or to guide you during patient programmer use. Troubleshooting 8 Warning screens Warning screens indicate a problem with the patient programmer, the antenna, or the neurostimulator. If the patient programmer audio preference is turned on, 3 tones alert you when a warning screen is displayed on the patient programmer. 166 English

167 Table 8.1 describes the possible warning screens and provides instructions (see blue text) on how to resolve the problem and clear the screen. Table 8.1 Warning screens Screen Synchronize patient programmer and neurostimulator Replace external neurostimulator batteries Replace patient programmer batteries Cause and action The patient programmer and the neurostimulator must be synchronized. Synchronize the patient programmer and neurostimulator. 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. The patient programmer batteries are depleted. Programming is not possible. Replace the patient programmer batteries now. Troubleshooting English 167

168 Table 8.1 Warning screens (continued) Troubleshooting 8 Screen Charge neurostimulator battery Device not supported EOS Call your clinician Cause and action The implanted rechargeable neurostimulator battery charge level is low and stimulation has stopped. Charge the implanted rechargeable neurostimulator battery now. Refer to the manual packaged with the charging system. See "Checking the implanted rechargeable neurostimulator battery" starting on page 74 for important information on low battery level and overdischarging. The implanted device that you are attempting to communicate with is not compatible with the patient programmer. Call your clinician. Error code = EOS: The neurostimulator has reached its end of service. Stimulation is not available. Call your clinician. 168 English

169 Table 8.1 Warning screens (continued) Screen POR Call your clinician Call your clinician Call your clinician Cause and action Error code = POR: Stimulation has stopped. Call your clinician to restart your therapy. Error codes 0 to 252: The system is not working correctly. Stimulation may have stopped. Remove batteries from the patient programmer, wait several seconds, then reinsert the batteries. If the error message appears again, call your clinician. Other codes: The system is not working correctly. Stimulation may have stopped. Write down the code shown on the screen. Call your clinician. Troubleshooting English 169

170 Information screens The information screens provide information about therapy settings, error conditions, and battery levels. If the patient programmer audio preference is turned on, 3 tones alert you when an information screen is displayed on the patient programmer. Table 8.2 describes the possible information screens and provides instructions on how to proceed (see blue text) when these messages appear. Troubleshooting English

171 Table 8.2 Information screens Screen Poor communication Description and action Communication between the patient programmer and the implanted neurostimulator 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. To clear the information screen, press any arrow on the Navigator key. Troubleshooting English 171

172 Table 8.2 Information screens (continued) Screen Poor communication Description and action Communication between the patient programmer and the external neurostimulator was unsuccessful. Reposition the patient programmer over the external 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. To clear the information screen, press any arrow on the Navigator key. Troubleshooting English

173 Table 8.2 Information screens (continued) Screen POR Reset occurred Disconnected cable Description and action The implanted neurostimulator has been reset. Stimulation is not available. Call your clinician to report this message screen. To clear the information screen, press any arrow on the Navigator key. 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. To clear the information screen, press any arrow on the Navigator key. Troubleshooting English 173

174 Table 8.2 Information screens (continued) Troubleshooting 8 Screen Rechargeable neurostimulator battery charge level is low External neurostimulator batteries are low Description and action The implanted rechargeable neurostimulator battery charge level is low and stimulation will not be available soon. Charge your implanted rechargeable neurostimulator battery. Refer to the manual packaged with the charging system. To clear the information screen, press any arrow on the Navigator key. 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. To clear the information screen, press any arrow on the Navigator key. 174 English

175 Table 8.2 Information screens (continued) Screen Patient programmer batteries are low Neurostimulator is nearing end of service Description and action The patient programmer batteries are low. You can finish programming. Replace the patient programmer batteries before the batteries become depleted. To clear the information screen, press any arrow on the Navigator key. The implanted neurostimulator is nearing end of service. Stimulation will not be available soon. Call your clinician to report this message screen. This screen reappears daily. After clearing this screen, a low battery level icon appears on the Status row of the Therapy screen. To clear the information screen, press any arrow on the Navigator key. Troubleshooting English 175

176 Table 8.2 Information screens (continued) Troubleshooting 8 Screen Synchronize Turn neurostimulator on Upper limit reached (amplitude shown) Description and action You tried increasing or decreasing a parameter for an inactive group. Activate the group by synchronizing the patient programmer and neurostimulator. To clear the information screen, press any arrow on the Navigator key. You tried increasing a parameter value with the neurostimulator off. Turn your neurostimulator on and try communication again. To clear the information screen, press any arrow on the Navigator key. You tried increasing a parameter (amplitude, pulse width, or rate) above the highest value allowed. To clear the information screen, press any arrow on the Navigator key. 176 English

177 Table 8.2 Information screens (continued) Screen Lower limit reached (amplitude shown) OOR upper limit reached (amplitude shown) Description and action You tried decreasing a parameter (amplitude, pulse width, or rate) below the lowest value allowed. To clear the information screen, press any arrow on the Navigator key. 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). To clear the information screen, press any arrow on the Navigator key. Troubleshooting English 177

178 Table 8.2 Information screens (continued) Troubleshooting 8 Screen 00R Out of regulation error Configure ENS error Description and action The neurostimulator cannot provide the programmed therapy or increase the parameter to the value that you requested. Call your clinician to report this message screen. To clear the information screen, press any arrow on the Navigator key. Your patient programmer cannot communicate with the ENS. The ENS will need to be reconfigured by your clinician. Call your clinician to report this message screen. To clear the information screen, turn off your patient programmer. Until your ENS is reconfigured by your clinician, this error message will appear when you attempt to communicate with the ENS. 178 English

179 Communication screens Communication screens indicate communication between the patient programmer and the neurostimulator. Table 8.3 describes the possible communication screens. Unless there is a problem with the communication, the communication screen automatically clears when the process is finished. Table 8.3 Communication screens Screen Description and action The patient programmer is communicating with the external neurostimulator. The patient programmer is communicating with the implanted neurostimulator. Possible problems and solutions Table 8.4 will help you solve problems associated with the patient programmer or Troubleshooting English 179

180 identify when to call your clinician. Problems are described in the left column (see bold black text). The right column lists possible causes of the problem (see plain text) and how to correct the problem (see bold blue text). Note: If a problem is not solved after several attempts, or if a problem is not described here, contact your clinician. Troubleshooting English

181 Table 8.4 Troubleshooting problems Problems Causes and actions Uncomfortable stimulation: You are too uncomfortable with the current stimulation to think about how to change it. The selected group or stimulation settings are not suitable for your current activity or posture. Turn the neurostimulator off. Reduce the amplitude for each program in the active group. Change the group if the active group is not one that is recommended by your clinician for your current activity or posture; or adjust the amplitude, pulse width, and rate to values that provide adequate pain relief. Troubleshooting English 181

182 Troubleshooting 8 Table 8.4 Troubleshooting problems (continued) Problems Causes and actions Intermittent stimulation: You feel stimulation only some of the time. Your clinician may have programmed your neurostimulator to turn on and off at regular intervals. If you are not receiving adequate pain relief, contact your clinician. 182 English

183 Table 8.4 Troubleshooting problems (continued) Problems Causes and actions Stimulation is off. No stimulation: You do not feel stimulation but you think stimulation should be on. Use your patient programmer to turn your neurostimulator on. Your clinician has programmed scheduled therapy and stimulation is scheduled to be stopped at this time. If stimulation is desired, select another group and turn stimulation on. The amplitudes for each program in the active group are set too low to feel. Use your patient programmer to increase the amplitude(s). Troubleshooting English 183

184 Troubleshooting 8 Table 8.4 Troubleshooting problems (continued) Problems Causes and actions Delayed stimulation changes: You do not feel stimulation right away after turning on the neurostimulator or you feel stimulation after turning off the neurostimulator. Patient programmer is unresponsive: The display screen is blank when you press a key. Your clinician programmed SoftStart/Stop so that stimulation starts and stops gradually. Allow about 8 seconds for your neurostimulator to turn on and off. You may feel a residual effect after the neurostimulator is turned off. The patient programmer batteries are depleted. Replace the patient programmer batteries. The patient programmer batteries are in backwards. Check the battery polarity and reinstall the patient programmer batteries. 184 English

185 Table 8.4 Troubleshooting problems (continued) Problems Causes and actions Dropped patient programmer: Your patient programmer falls off a cabinet or table. Fluid on the patient programmer: Fluid was spilled onto the programmer or the patient programmer was dropped into water. The patient programmer is designed to withstand a short drop to a hard surface and still operate normally, even if the case is chipped or nicked. Try the patient programmer; it should work. The patient programmer is not waterproof, and water can damage the device. Immediately remove the patient programmer from the water, then dry the patient programmer with a towel dampened with clean tap water. Remove the batteries, then allow the battery compartment to air dry at room temperature for 24 hours. Troubleshooting English 185

186 Troubleshooting English

187 9 Additional information

188 How stimulation works Nerve signals from all over your body travel to your spinal cord and then to your brain. Your brain translates the nerve signals into sensations such as pain. Stimulation delivers electrical pulses to the area where pain signals will be blocked as they move to the brain (Figure 9.1). Brain senses pain Brain senses tingling and reduced pain Stimulation pulse inhibits pain signal Additional information 9 Pain signal from foot Pain signal from foot Figure 9.1 Stimulation blocks pain signals as they move to the brain (spinal cord stimulation shown). 188 English

189 Note: Stimulation will not cure your pain, nor will it block sharp pain caused by a recent injury. To most patients, the stimulation pulses feel like a steady, tingling sensation in the painful area (Figure 9.2). Without stimulation: area of pain With stimulation: area of tingling Figure 9.2 Sensations with and without stimulation (spinal cord stimulation shown). Generally, people experience a fairly constant sensation of the electrical pulses from stimulation. However, you may feel changes when you suddenly move or change position. Additional information English 189

190 Additional information 9 The electrical pulses delivered by stimulation are defined by parameters called amplitude, pulse width, and rate. 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. Rate is the number of pulses delivered per second. Rate feels like "tapping." Your clinician uses a clinician programmer to communicate with your neurostimulator. Your clinician programs stimulation settings according to your needs. Your clinician designs stimulation options using programs to deliver electrical pulses to a specified pain site. A program defines the amplitude, pulse width, and rate of the stimulation pulse, as well as the specific location, pattern, or position in which the pulse will be delivered. 190 English

191 If your neurostimulator model supports the "groups" feature, your clinician can combine programs into "groups". A group is a collection of specific programs combined to provide stimulation to 1 or more pain sites, to provide different levels of stimulation for use during specific activities, or to provide stimulation that responds to changes in your position. A menu of groups can be designed by the clinician to meet a patient's specific needs. Typically, each group is designed for particular activities, positions, symptoms, or time of day. For example, Alex has received a spinal cord stimulation system. 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 used 3 programs (Program 1, Program 2, and Program 3) to design 2 groups (Group A and Group B) for Alex. Additional information English 191

192 Group A consists of Program 1 (for low back pain) and Program 2 (for thigh pain). Group B consists of Program 1, Program 2, and also Program 3 (ankle pain). Alex chooses whichever group he requires (Figure 9.3). Group A Low back and thigh Group B Low back, thigh and ankle Program 1 Program 2 Program 1 Program 2 Additional information 9 Program 3 Figure 9.3 Example of programs and groups. Your clinician will program specific programs and groups that you will be able to adjust with your patient programmer. Discuss this with your clinician. 192 English

193 Controlling your stimulation Your neurostimulator only accepts programming from the clinician programmer or patient programmer; other devices are not able to program your neurostimulator. 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. Additional information English 193

194 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. Additional information 9 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 cellular changes around the electrode(s), changes in the position of the electrode(s), loose 194 English

195 electrical connections, or lead or extension fractures. 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. In rare cases, excessive tissue growth around the electrode(s) may result in spinal cord compression and paralysis. Additional surgery is required to treat these complications, which can occur weeks to years after lead implantation. Additional information English 195

196 Additional information English

197 10 User assistance

198 User assistance 10 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 8.4 on page 181. Otherwise, contact your clinician. If you lose your patient programmer Contact your clinician to order a new patient programmer.! USA To register the patient programmer for service covered by the warranty, complete and mail the warranty registration. 198 English

199 Declaration of Conformity Medtronic declares that this product is in conformity with the essential requirements of Directive 90/385/EEC on Active Implantable Medical Devices and R&TTE Directive 1999/5/EC. For additional information, contact Medtronic. Refer to the list of Medtronic contacts at the end of this manual. User assistance English 199

200 User assistance English

201 11 Appendix A: Electromagnetic interference (EMI)