Neurological Medtronic Confidential Title Model 37742 Patient programmer: pain therapy user manual Medtronic Confidential This Document is the Property of Medtronic, Inc. and must be accounted for. Information hereon is confidential. DO NOT reproduce it, reveal it to unauthorized persons or send it outside Medtronic without proper authorization. Part No. Writer Theresa King-Hunter Part No.
Medtronic Confidential NeuroPatntR00 37742_FC.fm 10/13/04 10:16 am Size 4.625" x 6.
7742_FC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Medtronic®, Restore™, and SoftStart™ are trademarks of Medtronic, Inc. c FCC Information The following is communications regulation information on the Model 37741 Patient Programmer. FCC ID: LF537741 This device complies with Part 15 Rules.
Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 Contents 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742_Sym.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Label symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. CE 0123 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. The use of this device might be subject to individual country licensing regimes in Europe.
Medtronic Confidential NeuroPatntR00 37742_Sym.fm 10/13/04 10:17 am Size 4.625" x 6.
37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A company dedicated to patients Introduction 1 Medtronic was founded in 1949 by Earl Bakken, a graduate student in electrical engineering, and his brotherin-law, Palmer J. Hermundslie. Today Medtronic is the world leader in medical technology, pioneering therapies that restore health, extend life and alleviate pain.
Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN develop new ones. Although we are a large company, individual patients and their needs are still the driving force behind what we do and how we do it. Our goal is to improve the quality of your life. This booklet, which provides information about your neurostimulation system, is one small way we try to help. Welcome to the Medtronic family. We wish you well.
37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 system, and the risks, benefits, warnings, precautions, and patient activities related to your neurostimulation system. • Chapter 3, “Introduction to stimulation,” describes the therapy, neurostimulation system components, and recovery and care information. • Chapter 4, “Using your patient programmer,” describes the patient programmer and how to perform specific tasks.
Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient guides Table 1.1 describes the documents you should receive during test stimulation and after a neurostimulator is implanted. Table 1.1 Patient guides for test stimulation and implant Test (ENSa) Document Implant (INSb) ✓ Medtronic Model 37742 Patient Programmer: Pain Therapy User Manual. See page 13 for chapter details.
Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 1.1 Patient guides for test stimulation and implant (continued) Test (ENSa) Document a Medtronic Model 37751 Recharger: Charging System User Manual. Describes the charging system and how to use it with an implanted neurostimulator. ✓ Medtronic Model 37751 Recharger: Charging System Quick Reference Guide. Provides instructions for common charging system tasks.
Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 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.
Medtronic Confidential NeuroPatntR00 Introduction 1 37742_Ch01.fm 10/13/04 10:18 am Size 4.625" x 6.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Purpose of the device The Medtronic Model 37742 Patient Programmer is designed to program the Medtronic Model 37711 Restore Neurostimulator.
Medtronic Confidential NeuroPatntR00 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN diathermy) anywhere on your body because you have an implanted neurostimulation system. Energy from diathermy can be transferred through your implanted system, and can cause tissue damage, resulting in severe injury or death. Refer to “Appendix A: Electromagnetic interference (EMI)” on page 121 for more information.
Medtronic Confidential NeuroPatntR00 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN If you are on anticoagulation therapy you might be at greater risk for postoperative complications such as hematomas that could result in paralysis. Possible adverse effects Important therapy information 2 Adverse effects of stimulation are usually mild and go away when stimulation is turned OFF.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 stimulation, possibly related to cellular changes around the electrode(s), changes in the position of the electrode(s), loose electrical connections, or lead or extension fractures. It is also possible that the implanted materials could cause an allergic or immune system response.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 affect the operation of a neurostimulator. However, strong sources of 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.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Refer to Table 2.1, on page 26, and “Appendix A: Electromagnetic interference (EMI)” on page 121 for information on the sources of EMI, the effect of EMI on you and your neurostimulation system, and instructions on how to reduce the risk from EMI.
26 220907005 Rev X English 37742 2004-08 Printing instructions: Household items High-output ultrasonics /lithotripsy Electromagnetic field devices (eg, arc welding, power stations) ✓ ✓ ✓ ✓ ✓ Electrocautery Electrolysis ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ Momentary increase in stimulation Device damage ✓ ✓ Serious patient injury Diathermy, therapeutic Dental drills and probes Defibrillation/ cardioversion Bone growth stimulators Device/procedure ✓ ✓ Device turns OFF or ON ✓ ✓ ✓ ✓ Intermitte
220907005 Rev X 37742 2004-08 English Printing instructions: ✓ ✓ Serious patient injury ✓ ✓ ✓ ✓ ✓ ✓ Momentary increase in stimulation ✓ ✓ Device damage Important therapy information 2 Theft detectors/security devices Therapeutic magnets Radiofrequency (RF)/ microwave ablation Radiation therapy Psychotherapeutic procedures Magnetic resonance imaging (MRI) Laser procedures Device/procedure ✓ ✓ ✓ ✓ Device turns OFF or ON ✓ ✓ ✓ ✓ Intermittent stimulation page 130 page 138 pa
28 220907005 Rev X Transcutaneous electrical nerve stimulation (TENS) Therapeutic ultrasound Device/procedure Device damage ✓ Serious patient injury ✓ ✓ Momentary increase in stimulation ✓ Device turns OFF or ON ✓ Intermittent stimulation page 135 page 122 See guidelines Table 2.1 Potential effects of EMI from devices or procedures (continued) Important therapy information 2 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Neurostimulator interaction with cardiac implantable devices – When a neurostimulator and an implanted cardiac device (eg, pacemaker, defibrillator) are required, the doctors involved with both devices (neurologist, neurosurgeon, cardiologist, cardiac surgeon) should discuss the possible interaction between the devices before surgery.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 should reprogram your neurostimulator to a bipolar configuration and a minimum rate of 60 Hz. The cardiac device should be programmed to bipolar sensing.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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).
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Important therapy information 2 Patient device handling – To avoid damaging the device, do not immerse it in liquid; do not clean it with bleach, nail polish remover, mineral oil, or similar substances; and do not drop it or mishandle it in a way that may damage it.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Component manipulation – Do not manipulate or rub your neurostimulation system through the skin; this is sometimes called “Twiddler’s Syndrome.” Manipulation can cause damage to your system, lead dislodgement, skin erosion, or stimulation at the implant site. Manipulation may also flip your device so that it can’t be charged.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Important therapy information 2 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.
37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 some patients have described as uncomfortable stimulation (a jolting or shocking sensation). You should reduce your amplitude to the lowest setting and turn OFF your neurostimulator before engaging in activities that could become unsafe for you or others if you received an unexpected jolt or shock (eg, driving, operating power tools). Discuss these activities with your doctor.
742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • you are not an appropriate candidate for surgery. • you cannot properly operate the system. • you do not receive satisfactory results from test stimulation.
37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN How stimulation works Nerve signals from all over your body travel to your spinal cord and then to your brain. Your brain translates the signals into sensations such as pain. Introduction to stimulation 3 Stimulation delivers electrical pulses to the area where your pain signals will be blocked as they move to the brain (Figure 3.1).
37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Note: Stimulation will not cure your pain, nor will it block sharp pain caused by a recent injury. Area of pain Area of stimulation Figure 3.2 Stimulation feels like tingling in the area of pain. Generally, people experience a fairly constant sensation of stimulation. However, you may feel changes when you suddenly move or change position.
Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Parts of your system A typical neurostimulation system has implanted parts that deliver the electrical pulses to the area where your pain signals are blocked. Typically the implanted parts are: a neurostimulator, one or two leads, and one or two extensions (optional) (Figure 3.3).
37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient programmer Medtronic Confidential NeuroPatntR00 Charging system Detachable antenna (optional) Carrying case Neurostimulator – The neurostimulator is the power source for your neurostimulation system. It contains electronics that generate the electrical pulses. During test stimulation, an external neurostimulator is used to determine whether an implanted neurostimulator is the right choice for you.
37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Lead(s) – A lead is a thin wire 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 thin wire, covered with a protective coating, that connects the neurostimulator to a lead.
37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Understanding your therapy Stimulation delivers electrical pulses to the area where your pain signals will be blocked as they travel to the brain. The electrical pulses are made up of 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.
37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 For example, Alex has pain in his low back and right thigh. Typically, Alex’s pain doesn’t vary; however, sometimes Alex has additional pain in his right ankle. Alex’s clinician designed two groups for Alex to choose from. Group A is for Alex’s typical pain; group B is for the additional ankle pain (Figure 3.5). Alex chooses whichever group he requires.
Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 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 What you control As your activities vary throughout the day, your therapy needs may change.
37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 group. Talk to your clinician about the settings that apply to your therapy. Charging Introduction to stimulation 3 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.
Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • 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 has been overdischarged and restored twice before.
Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Recovery and care Recovering from surgery It takes several weeks to heal from surgery. It is normal to feel some discomfort from the incision(s) and to have some pain at the 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.
Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • Avoid activities where you must bend, stretch, or twist your body; these movements can move your leads which affects your stimulation. • 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).
Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 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 surgery. Discuss your activity level with your doctor.
37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Care schedule Introduction to stimulation 3 Your clinician will schedule follow-up visits to make sure you are receiving the most appropriate therapy.
Medtronic Confidential NeuroPatntR00 Introduction to stimulation 3 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.
37742_Ch04.fm 10/13/04 10:18 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN How the patient programmer works Using your patient programmer 4 The patient programmer communicates with your neurostimulator by sending signals to and receiving signals from the neurostimulator. To send and receive the signals, the internal antenna of the programmer must be placed over the neurostimulator (Figure 4.1).
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient programmer Neurostimulator Internal antenna Figure 4.1 Place the patient programmer over the neurostimulator. The patient programmer is used to: • turn the neurostimulator ON or OFF. Synchronizing and displaying the THERAPY screen Synchronizing sends the settings from your neurostimulator to the patient programmer.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • To synchronize your neurostimulator and the patient programmer, hold the programmer over your neurostimulator and press one of the three keys shown in Figure 4.2. Using your patient programmer 4 Note: Using the NEUROSTIMULATOR ON key to synchronize also turns On the neurostimulator. Using the NEUROSTIMULATOR OFF key to synchronize also turns Off the neurostimulator.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Status row Group row Parameter row Figure 4.3 THERAPY screen. Using your patient programmer 4 Icons on the THERAPY screen indicate your neurostimulator settings and the battery level of your neurostimulator and patient programmer (Table 4.1).
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.1 THERAPY screen icons (continued) Row Parameter Icons b Description Amplitude Pulse width Rate b If only one group is available, this row is blank. If you cannot change any parameters, this row is blank. If your clinician programmed therapy to occur at a specific time, the scheduled therapy ( ) icon is shown in the Group row (Figure 4.4).
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • Group B is active most of the day and stimulation is ON • Stimulation is stopped during sleep Stimulation is stopped Group B is active Figure 4.4 Example of scheduled therapy. Using your patient programmer 4 Checking the external neurostimulator battery Check the external neurostimulator battery level every day.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Battery level Replace batteries Full Figure 4.5 External neurostimulator battery status on the THERAPY screen. Screens indicating that the external neurostimulator batteries need immediate replacement are described in Table 5.1 and Table 5.3. Checking the implanted neurostimulator battery Check the implanted neurostimulator battery charge level every day.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 with the screen facing outward and press the SYNC key. The THERAPY screen appears displaying the implanted neurostimulator battery level (Figure 4.6). Using your patient programmer 4 Caution: Charge the neurostimulator when you see a low battery ( ) screen on the patient programmer or recharger; this prevents the battery from overdischarging (see glossary).
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN – 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. Battery charge level Full Figure 4.6 Implanted neurostimulator charge level on the THERAPY screen.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN If the implanted neurostimulator needs immediate charging, you will see one of the screens shown on Table 4.2. Table 4.2 Neurostimulator battery screens The implanted neurostimulator battery charge level is low and stimulation will not be available soon. Charge your implanted neurostimulator battery. Refer to the manual packaged with the charging system.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.2 Neurostimulator battery screens (continued) Caution: Charge the neurostimulator when you see a low battery ( ) screen on the patient programmer or recharger; this prevents the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Guidelines for adjusting your stimulation Using your patient programmer 4 To receive the most effective therapy, some days you may need to adjust your stimulation several times; other days you may not need to adjust it at all. Your clinician will provide complete guidelines about when you may want to adjust your stimulation. Table 4.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.3 Stimulation adjustment guidelines (continued) Situation Action You have unexpected changes in stimulation 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 Using your patient programmer 4 Change to a different group and turn ON the neurostimulator.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Turning your neurostimulator ON or OFF 1. Hold the programmer over your neurostimulator with the programmer screen facing outward and press the NEUROSTIMULATOR ON or NEUROSTIMULATOR OFF key (Figure 4.7). The THERAPY screen appears. ON OFF Figure 4.7 Turning your neurostimulator ON or OFF.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 (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.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • When a stimulation setting is changed, you will see the change on the THERAPY screen. • If audio is ON, you will hear one tone that means the change was effective. Three rapid tones mean the change did not occur. Using the NAVIGATOR key Figure 4.8 NAVIGATOR key.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • 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. Using your patient programmer 4 • When moving the selection box with the NAVIGATOR key, you do not need to hold the programmer over your neurostimulator.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Changing a group 1. Hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key. The THERAPY screen appears. 2. Press the up arrow on the NAVIGATOR key to move the selection box to the Group row (Figure 4.10). Figure 4.10 Group row. 3.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Figure 4.11 Move to a new group. 4. Hold the programmer over your neurostimulator and press the SYNC key to send the change to your neurostimulator (Figure 4.12). Using your patient programmer 4 5. Verify that the new group is active the THERAPY screen (Figure 4.12). 74 220907005 Figure 4.12 Active group.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Increasing or decreasing a parameter (amplitude, pulse width, or rate) Notes: • To increase a parameter, the neurostimulator must be ON. 1. Hold the patient programmer over your neurostimulator with the screen facing outward and press the NEUROSTIMULATOR ON , NEUROSTIMULATOR OFF , or SYNC key. The THERAPY screen appears.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 2. Press the left or right arrow on the NAVIGATOR key to move the selection box to the desired parameter (Figure 4.13). Parameter row Figure 4.13 Move to parameter row.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN needed (Figure 4.14). The increase or decrease occurs immediately and is saved in the neurostimulator. DECREASE INCREASE Figure 4.14 DECREASE and INCREASE keys. – Pressing and holding the INCREASE or DECREASE key changes the value every half-second. – If one of the information screens in Table 4.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.4 Parameter limit screens Lower limit You tried to decrease a parameter (amplitude, pulse width, or rate) below the lowest value allowed. Press any arrow on the Navigator key to clear the screen. Upper limit Press any arrow on the Navigator key to clear the screen.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Patient programmer batteries Always keep two new AAA alkaline batteries available for replacement. New batteries provide about two months 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.
37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Battery level Replace batteries Full Figure 4.15 Patient programmer battery level. If the programmer batteries need immediate replacement, one of the screens shown in Table 4.5 appears. Table 4.5 Patient programmer battery replacement screens Using your patient programmer 4 The patient programmer batteries are low. You can finish programming.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Replacing patient programmer batteries Figure 4.16 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 1.
37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Summary of keys DECREASE NEUROSTIMULATOR ON NEUROSTIMULATOR OFF SYNC INCREASE POWER/ BACKLIGHT NAVIGATOR Using your patient programmer 4 Figure 4.17 Patient programmer keys.
37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.6 Summary of keys Key Function Turns the neurostimulator ON OFF . ON OFF or • The programmer must be held over the neurostimulator while pressing the NEUROSTIMULATOR ON or OFF key. • Pressing either of these keys also automatically synchronizes the neurostimulator and programmer and displays the THERAPY screen. Synchronizes the neurostimulator and programmer.
37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.6 Summary of keys (continued) Key Function Decreases parameter. Decrease Increase or increases a • The programmer must be held over the neurostimulator while pressing the INCREASE or DECREASE key. • Pressing and holding the INCREASE or DECREASE key changes the parameter every half-second. • To increase a parameter, the neurostimulator must be turned ON.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Preferences: Changing the audio, contrast, time, and time/ number format Programmer preferences are accessed from the Status row of the THERAPY screen. Table 4.7 lists the preference icons. Table 4.7 Preference icons Icons Preference Audio Contrast Time and number format 1. Hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key.
37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 2. Press the up arrow on the NAVIGATOR key to move the selection box to the Status row (Figure 4.18). Status row Figure 4.18 Preferences are accessed from the Status row. Using your patient programmer 4 3. Press the left or right arrow on the NAVIGATOR key to move the selection box to the desired preference (Figure 4.19). 86 220907005 Desired preference Figure 4.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Change row Figure 4.20 Move to Change row. 5. Follow the steps in Table 4.8 to change the selected preference. Table 4.8 Changing preferences 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 89. Contrast 1. Press the left or right arrow on the NAVIGATOR key to make the contrast lighter or darker . 2.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.8 Changing preferences (continued) 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.
37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.8 Changing preferences (continued) Time and number format 3.50 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 with a 24-hour clock and numbers with commas. 2. Go to step 6, page 89. 7. Press the left or right arrow on the NAVIGATOR key to move to another preference or return to the THERAPY screen.
37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 The case also has a loop on the back that attaches to a belt. Figure 4.21 Insert the programmer into the case. Using your patient programmer 4 Place an identification label on the back of your patient programmer in case the programmer is lost (Figure 4.22). 90 220907005 ID label Figure 4.22 Place the adhesive label on the back of the programmer.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Optional detachable antenna The detachable antenna is available if you have difficulty reaching the neurostimulator. It is also useful for viewing the patient programmer screen while you are adjusting stimulation. Connecting the antenna Figure 4.23 Place the antenna over your neurostimulator.
Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 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 4.24). Using your patient programmer 4 a 92 220907005 b Figure 4.24 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.
37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Figure 4.25 Insert the antenna plug into the antenna jack. Using the antenna When you have finished using the patient programmer, grasp the antenna plug and pull it out. Caution: Do not pull directly on the antenna cable to disconnect the cable from the programmer because this may damage the antenna cable.
Medtronic Confidential NeuroPatntR00 Using your patient programmer 4 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.
37742_Ch05.fm 10/13/04 10:20 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN This chapter will help you solve problems with your 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.
Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN describes warning screens and provides instructions (see blue text) on how to resolve the problem and clear the screen. Table 5.1 Warning screens Screen Cause and action Synchronize programmer and neurostimulator The programmer and the neurostimulator must be synchronized. Synchronize the programmer and neurostimulator.
Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.1 Warning screens (continued) Screen Cause and action Charge the implanted neurostimulator battery The neurostimulator battery charge level is low and stimulation has stopped. Charge the neurostimulator battery now. Refer to the manual packaged with the charging system.
Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.1 Warning screens (continued) Screen Cause and action - 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.
Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Communication screens The communication screens show you that a process is in progress. Table 5.2 describes the communication screens for your neurostimulation system. The communication screens automatically clear when the neurostimulation system finishes the process. Troubleshooting 5 I 100 220907005 Table 5.
37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 your programmer and neurostimulator. If the audio is ON, three tones alert you to the message. Table 5.3 describes information screens and instructions on how to proceed (see blue text). Note: Press any arrow on the NAVIGATOR key to clear an information screen. Table 5.
Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.3 Programmer information screens (continued) Screen Description and action Poor communication The programmer attempted to communicate with the external neurostimulator, but communication was unsuccessful. Reposition the programmer over the external neurostimulator with the programmer screen facing outward and try communication again.
37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 5.3 Programmer information screens (continued) Screen Description and action Upper limit (amplitude shown) You tried increasing a parameter (amplitude, pulse width, or rate) above the highest value allowed. Lower limit (amplitude shown) You tried decreasing a parameter (amplitude, pulse width, or rate) below the lowest value allowed.
Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.3 Programmer information screens (continued) Screen Description and action Implanted neurostimulator battery charge level is low The implanted neurostimulator battery charge level is low and stimulation will not be available soon. Charge your implanted neurostimulator battery. Refer to the manual packaged with the charging system.
37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 5.3 Programmer information screens (continued) Screen Description and action Sync up You tried increasing or decreasing a parameter for an inactive group. Synchronize the programmer and neurostimulator. Patient programmer information Troubleshooting 5 These screens provide Neurostimulation information to your clinician or Medtronic during system troubleshooting.
37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Possible problems and solutions Table 5.4 will help you solve problems or identify when to call your clinician. Problems are described in the left column (bold black text). The right column lists possible causes of the problem (plain text) and how to correct the problem (bold blue text).
220907005 Rev X Troubleshooting 5 The selected group or stimulation settings are not suitable for your current activity or posture. Uncomfortable stimulation: You are too uncomfortable with the current stimulation to think about how to change it. 4. 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. 3. Reduce the rate for the active group.
108 220907005 Rev X Intermittent stimulation: You feel stimulation only some of the time. Your clinician programmed SoftStart/Stop so that stimulation starts and stops gradually: Delayed stimulation changes: You do not feel stimulation right away after turning ON the neurostimulator or you feel stimulation after turning OFF the neurostimulator. Your clinician may have programmed your neurostimulator to turn ON and OFF at regular intervals.
220907005 Rev X Troubleshooting 5 Stimulation is OFF. No stimulation: You do not feel stimulation but you think stimulation should be ON. Use your patient programmer to increase the amplitude(s). The amplitudes for each program in the active group are set too low to feel. If stimulation is desired, select another group and turn stimulation ON. Your clinician has programmed scheduled therapy and stimulation is scheduled to be stopped at this time.
110 220907005 Rev X Dropped programmer: Your patient programmer falls off a cabinet or table. The programmer batteries are depleted. Patient programmer is unresponsive: The display screen is blank when you press a key. Try the patient programmer; it should work. 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. Check the battery polarity and reinstall the patient programmer batteries.
220907005 Rev X Troubleshooting 5 The patient programmer is not waterproof, and water can damage the device. Fluid on the programmer: Fluid was spilled onto the programmer or the programmer was dropped into water. Remove the batteries, then allow the battery compartment to air dry at room temperature for 24 hours. Immediately remove the programmer from the water, then dry the programmer with a towel dampened with clean tap water. Causes and actions Problems Table 5.
37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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 list of Medtronic contacts at the end of this manual. The serial number is located in the battery compartment. This number identifies each patient programmer.
37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN This section describes how to care for and dispose of your patient programmer and accessories. 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.
Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • Follow all warnings and precautions in chapter 2 “Important therapy information” and chapter 7 “Appendix A: Electromagnetic interference (EMI)”. • Handle the device with care. Do not drop, strike, or step on the device. • Do not dismantle or tamper with the device. • Clean the outside of the device with a damp cloth when necessary.
Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 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 the patient programmer requires repair or is nonfunctional, send it to the address listed below. USA Medtronic, Inc.
Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Battery and programmer disposal Dispose of depleted batteries and worn out devices according to local requirements. If you no longer need your programmer and would like to donate it, contact your clinician. Neurostimulator disposal Maintenance 6 The implanted device should be removed before burial or cremation.
Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Declaration of conformity Medtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment, and Directive 90/385/EEC on Active Implantable Medical Devices. Maintenance 6 For additional information, contact Medtronic. Refer to the list of Medtronic contacts at the end of this manual.
Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Specifications Table 6.1 Patient programmer specifications Item Specification Power source 2 AAA alkaline batteries (non-rechargeable, LR03) Operating temperature +9 to +43°C (+49 to +110°F) Storage temperature -40 to +65°C (-40 to +150°F) Operating/storage 30% to 95% relative humidity Size Approximately 9.4 x 5.6 x 2.8 cm (3.7 x 2.2 x 1.
Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 6.2 Implanted neurostimulation system specifications Description Specifications Typical materials in contact with human tissuea Titanium Polyurethane Silicone rubber Polysulfone Silicone medical adhesive Lead Polyurethane Platinum iridium Extension Polyurethane For a complete list of materials in contact with human tissue, contact your clinician.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Appendix A: Electromagnetic interference Please review “Electromagnetic interference (EMI)” on page 23 and Table 2.1 on page 26 for additional information. 122 220907005 Before any medical procedure is begun, always inform any health care personnel that you have an implanted neurostimulation system.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 diathermy can be transferred through your implanted system, can cause tissue damage, and can result in severe injury or death. Personal injury or device damage can occur during diathermy treatment when: • the neurostimulation system is turned ON or OFF. • diathermy is used anywhere on your body (not just where your neurostimulation system is located).
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Warnings Appendix A: Electromagnetic interference EMI from the following medical procedures or equipment can damage the device, interfere with device operation, or cause you harm.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • The lowest clinically appropriate energy output (watt seconds) should be used. After external defibrillation, your doctor should confirm that the neurostimulation system is working as intended. • The insulation on the lead or extension can be damaged, causing the lead or extension to fail or causing induced currents that can damage tissue or stimulate or shock you.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 When electrocautery is necessary, these precautions must be followed: • The neurostimulator should be turned OFF before using electrocautery. • Bipolar cautery should be used. • If unipolar cautery is necessary: – only low-voltage modes should be used. Appendix A: Electromagnetic interference – the lowest possible power setting should be used.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Magnetic resonance imaging (MRI) – Medtronic recommends that an MRI should not be prescribed for you if you have any part of an implanted neurostimulation system. Exposing you to an MRI can potentially injure you or damage your neurostimulator.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Note: This warning applies even if only a lead or an extension is implanted in your body.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • An MRI can permanently damage the neurostimulator, requiring it be removed or replaced. • The neurostimulator can move within the implant pocket and align with the MRI field, resulting in discomfort or reopening of a recent implant incision. In addition, the MRI image can be degraded, distorted, or blocked from view by your implanted neurostimulation system.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Appendix A: Electromagnetic interference Theft detectors and security devices – Use care when approaching theft detector and security devices (such as those found in airports, libraries, and some department stores). When approaching these devices, do the following: 130 220907005 1.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Double Security gate Medtronic Confidential NeuroPatntR00 Single security gate (stay as far as possible from gate) Note: Some theft detectors might not be visible. 3. Proceed through the security device. Do not linger near or lean on the security device. 4. After you pass through the security device, turn your neurostimulator ON again.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Precautions Appendix A: Electromagnetic interference EMI from the following equipment is unlikely to affect your neurostimulation system if the guidelines below are followed: 132 220907005 Bone growth stimulators – The coils of an external magnetic field bone growth stimulator should be kept 45 cm (18 in) away from the neurostimulation system.
Medtronic Confidential NeuroPatntR00 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • Television and radio transmitting towers (safe if outside the fenced area) If you suspect that equipment is interfering with the neurostimulation system, do the following: 1. Move away from the equipment or object. Appendix A: Electromagnetic interference 2. If possible, turn off the equipment or object. 134 220907005 3.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Radiation therapy – High radiation sources such as cobalt 60 or gamma radiation should not be directed at the neurostimulation system. If radiation therapy is required near the neurostimulation system, lead shielding should be placed over the device to help prevent damage.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 discontinue using the TENS until you talk with your doctor. Notes Appendix A: Electromagnetic interference Household items – Most household appliances and equipment that work properly and are properly grounded will not interfere with the neurostimulation system.
37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • Radio frequency sources: Keep AM/FM radios, and cellular, cordless, and conventional telephones at least 10 cm (4 in) away from the implanted neurostimulator. • Stereo speakers and radios for the home or car: Do not lift or carry them close to or touching the part of your body where the neurostimulator is located.
Medtronic Confidential NeuroPatntR00 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 15 cm (6 in) away from the neurostimulation system. • Diagnostic X-rays or fluoroscopy Appendix A: Electromagnetic interference Note: Tight pressure in the area of your neurostimulator, such as used during mammography, can damage the neurostimulator or disconnect components of your neurostimulation system. This will require surgery to replace or repair the neurostimulation system.
37742_GLS.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Glossary Amplitude – The strength or intensity of an electrical pulse. Caution – A statement describing actions that could result in damage to or improper functioning of a device. Charging system – Equipment used to charge the battery inside an implanted neurostimulator. Clinician – A healthcare professional such as a doctor or nurse.
Medtronic Confidential NeuroPatntR00 37742_GLS.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 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.
Medtronic Confidential NeuroPatntR00 37742_GLS.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Group – Combined programs that provide stimulation to one or more pain sites. Each group may be defined for a different activity, symptom, or time of day. Group row – The middle row on the THERAPY screen. This row includes groups that a patient can change. Implanted neurostimulator – See Neurostimulator.
37742_GLS.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 – 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.
Medtronic Confidential NeuroPatntR00 37742_GLS.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient programmer – A hand-held device that allows you to turn your neurostimulator ON and OFF. It is also used to adjust some stimulation settings. Program – Stimulation directed to a specific pain site. Precaution – See Caution. Pulse width – The length or duration of an electrical pulse. Rate – The number of electrical pulses delivered each second.
37742_GLS.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Status row – The top row on the THERAPY screen. Icons represent information about the neurostimulator and the patient programmer. Stimulation – The delivery of electrical pulses to the area where pain signals are blocked as they move to the brain. Stimulation blocks some pain signals from reaching the brain.
37742_GLS.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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. THERAPY screen – The main screen displayed on the patient programmer. Warning – A statement describing an action or situation that could harm the patient.
Medtronic Confidential NeuroPatntR00 Glossary 37742_GLS.fm 10/13/04 10:22 am Size 4.625" x 6.
37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.
Index 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 Dental drills 132 Diathermy 20, 122 Disposing of implanted neurostimulator 117 patient programmer 117 patient programmer batteries 117 Driving 35 Electrocautery 125 Electrolysis 132 Electromagnetic field devices 133 Electromagnetic interference (EMI) 23–28, 122–138 Error codes 99 Extensions 42 External neurostimulator See Neurostimulator (external) Fluoroscopy 138 Group row 57, 73 Group row icons 58 Group, changing 73–74 Groups 43–44 Hiking 34 Household items 136 Hyperb
37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 Neurostimulator (implanted) battery level screen 104 battery warning screen 98 charging the battery 46, 63–64 checking battery level 61–64 description 41 disposing of 117 turning ON or OFF 69 when to turn OFF 35 Neurostimulator OFF key 56, 83 Neurostimulator ON key 56, 83 Number format preference 85–89 Options icon 72 Parameter limit screens 78 Parameter row 57 Parameter row icons 59 Parameter, increasing or decreasing 75–78 Patient identification card 17 Patient progra
Medtronic Confidential NeuroPatntR00 Index 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.
Medtronic Confidential NeuroPatntR00 Status row 57, 86, 88 Status row icons 58 Stimulation adjusting settings 70–78 description 38 guidelines for adjusting 66–68 troubleshooting 107–109 uncomfortable 69, 107 unexpected 69 unexpected changes 34, 68 Sync key 56, 83 Synchronizing 55, 56 Test stimulation 41 Theft detectors 130 Therapy screen 55, 56 Therapy screen icons 57 Time format preference 85–89 Time preference 85–89 Tones, audio 71, 96, 101 Transcutaneous electrical nerve stimulation (TENS) 135 Turning n
Medtronic Confidential NeuroPatntR00 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.
37742_bcv.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Contacts: Asia: Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza, The Lee Gardens, 33 Hysan Avenue, Causeway Bay, Hong Kong Tel. 852-2891-4068 Fax 852-2591-0313 Medtronic Asia Ltd. 3 Floor Peter Building, 570-6 Shinsa-Dong Kangnam-ku, Seoul 135-120, South Korea Tel. 82-2-548-1148 Fax 82-2-518-4786 Australia: Medtronic Australasia Pty. Ltd.
37742_bcv.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Internet: www.medtronic.com Tel. 1-763-505-5000 Fax 1-763-505-1000 Medtronic E.C. Authorized Representative/Distributed by Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel.