Medtronic 7434A Patient Programmer User Manual manual

Medtronic, Inc. Patient Programmer manual

manual

User ManualRx OnlyItrel®EZ™Model 7434A Patient Programmer9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 1
9VProgrammerBatteryNeurostimulatorBatteryExplanation of Symbols on Products and PackagingKeypad Symbols Stimulation ControlSwitch SymbolsStatus Light SymbolsNeurostimulator OffIncrease RateVolume OffHigh VolumeNeurostimulator OnDecrease AmplitudePulse WidthLow VolumeNeurostimulator OffNeurostimulator OnBeeper Volume ControlSwitch SymbolsMiscellaneous SymbolsPositioning Symbol IEC 60601-1/EN60601-1,Type BF EquipmentAntenna ConnectorConformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive 90/385/EEC.For U.S. audiences only.Equipment has been tested and accepted for listing under the Canadian Standard Association, for distribution in Canada.Storage Temperature Atmospheric PressureRelative Humidityc®/Refer to the appropriate product to see symbols that apply.Risk Class 2wXX %XX %XXX hPaXX.X in. HgXX hPaXX.X in. HghPaAttention, see accompanyingdocuments9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 2
To turn the neurostimulator on: a) Press the Neurostimulator On key. Listen for theconfirmation beep.b) Check that the green Neurostimulator On light is lit. This light stays on for 8 seconds after you release the key.To turn the neurostimulator off:a) Press the Neurostimulator Off key. Listen for theconfirmation beep.Medtronic® Itrel® EZ™Model 7434A9VTo turn the neurostimulator on or off:Place the programmer over your neurostimulator.Itrel®EZ™Patient Programmer Quick Programming GuideGreenNeurostimulator“On“ Lightb) Check that the yellow Neurostimulator Off light is lit. This light stays on for 8 seconds after you release the key.YellowNeurostimulator“Off“ LightBack of Patient Programmer231Location of Neurostimulator9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 3
To adjust amplitude, rate, or pulse width:Remove the battery compartment cover.Select thestimulation setting: amplitude ( ), rate ( ), or pulse width ( ).Place theprogrammerover your neurostimulator.Press the neurostimulatorOn key. Listen for theconfirmation beep.+lSN9V IEC-6LR61Press the Increase ( ) orthe Decrease ( ) key to make a change. You should hear one beep for each change.Repeat steps 2-5 for other stimulation settings. Replace the battery cover.SOUND ACTIONOne beep You have pressed the On/Off orIncrease/Decrease key and the change was received by theneurostimulator.Three Indicates one of the following:rapid • You tried to adjust the beeps lowest neurostimulator beyond theor highest settings.• You tried to increase stimulationwith the neurostimulatorturned off.562341If the patient programmer beeps:9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 4
A COMPANY DEDICATED TO PATIENTSMedtronic was founded in 1949 by Earl Bakken, a graduate student inelectrical engineering, and his brother-in-law, Palmer J. Hermundslie. TodayMedtronic is the world leader in medical technology, pioneering therapiesthat restore health, extend life, and alleviate pain.From its modest beginnings in a 600-square-foot Minneapolis garage, wehave transformed Medtronic into a worldwide company that servescustomers in more than 120 countries. Each year, millions of patients aretreated with Medtronic products and therapies. We invest almost $500million each year in research and development, working closely with theworld’s leading physicians and scientists to enhance our current productsand therapies, and to develop new ones. Although we are a large company,individual patients and their needs are still the driving force behind what wedo and how we do it.Our goal is to improve the quality of your life. This booklet, which providesinformation about your stimulation system, is one small way we try to help.Welcome to the Medtronic family. We wish you well.9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 5
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CONTENTSABOUT THIS BOOKLET.................................................................. 1INTRODUCTION ............................................................................... 3Indications..................................................................................................3Contraindications .....................................................................................3Warnings .................................................................................................... 4Precautions ................................................................................................ 6Risks of Surgery ........................................................................................9Possible Side Effects.............................................................................. 10Changes in Therapy............................................................................... 10Possible Device Complications ........................................................... 11RECOVERING FROM SURGERY................................................. 12Healing..................................................................................................... 12Physical Therapy and Medications..................................................... 12Activities...................................................................................................13WHAT IS PAIN? ................................................................................ 15WHAT IS STIMULATION AND HOW DOES IT MANAGE PAIN?............................................................................. 15 i9900213EN/197877_001/ccs 1/29/01 2:18 PM Page i
WHAT DOES YOUR STIMULATION SYSTEMLOOK LIKE?..................................................................................... 17HOW DOES YOUR STIMULATION SYSTEM WORK? ...........19HOW DOES STIMULATION FEEL?............................................. 22HOW IS YOUR ITREL 3 SYSTEM IMPLANTED?......................25WHAT DOES THE PATIENT PROGRAMMER DO?................ 30HOW DOES THE PATIENT PROGRAMMER WORK? ........... 31PATIENT PROGRAMMER FEATURES ....................................... 32Keypad...................................................................................................... 33On/Off Keys ..................................................................................... 34Increase and Decrease Keys ........................................................... 34Control Switches .................................................................................... 35Stimulation Control Switch ........................................................... 36Beeper Volume Control Switch ..................................................... 37Symbols and Status Lights................................................................... 38Symbols.............................................................................................. 38Status Lights...................................................................................... 38ii9900213EN/197877_001/ccs 1/29/01 2:18 PM Page ii
USING THE PATIENT PROGRAMMER ..................................... 41Placing the Programmer over the Neurostimulator ....................... 41Checking the Neurostimulator Battery ............................................. 43Turning the Neurostimulator On and Off......................................... 45Adjusting Your Stimulation .................................................................. 52Programming Tips............................................................................ 53Decreasing the Amplitude to the Lowest Setting........................ 56Adjusting the Pulse Width.............................................................. 57Adjusting the Rate............................................................................ 60Adjusting the Amplitude ................................................................ 62ACCESSORIES................................................................................... 65Wrist Strap and Carrying Case ........................................................... 65Detachable Antenna.............................................................................. 67Attaching the Antenna over the Neurostimulator...................... 69Connecting the Antenna to the Patient Programmer ................. 71Disconnecting the Antenna............................................................. 71Caring for the Antenna.................................................................... 73Caring for Your Skin ........................................................................ 74Using your Control Magnet (Optional) ............................................ 75iii9900213EN/197877_001/ccs 1/29/01 2:18 PM Page iii
CARING FOR YOUR PATIENT PROGRAMMER..................... 79Battery Cover .......................................................................................... 79Removing the Battery Cover .......................................................... 79Replacing the Battery Cover .......................................................... 80Identification Label................................................................................ 81Checking the Programmer Battery..................................................... 83Removing the Battery............................................................................ 85Installing the Battery ............................................................................. 86Cleaning and Care................................................................................. 88Service ...................................................................................................... 90Battery and Device Disposal................................................................ 90TROUBLESHOOTING..................................................................... 92LIVING WITH YOUR STIMULATION SYSTEM.................... 102Patient Identification Card ................................................................. 102When to Call Your Doctor................................................................... 104Do’s and Don’ts .................................................................................... 106Environmental Problems.................................................................... 108Battery Information................................................................................112Battery and Device Disposal.............................................................. 113Medical and Dental Procedures........................................................ 114iv9900213EN/197877_001/ccs 1/29/01 2:18 PM Page iv
COMMONLY ASKED QUESTIONS........................................... 117SPECIFICATIONS........................................................................... 123SPECIAL NOTICE........................................................................... 124LIMITED WARRANTY .................................................................. 125GLOSSARY....................................................................................... 134WARRANTY REGISTRATION CARD....................................... 139QUICK PROGRAMMING GUIDE ............................................. 1417General WarningThe Medtronic®Itrel®EZ™Model 7434A Patient Programmer (the“Programmer“) is designed to program the adjustable parameters of theMedtronic®Itrel®3 Implantable Neurostimulator (the “neurostimulator“).Do not attempt to use the programmer on another device (for example, acardiac pacemaker). Radio signals from the patient programmer mayinterfere with the performance of other implantable devices. v9900213EN/197877_001/ccs 1/29/01 2:18 PM Page v
FCC INFORMATIONThe following is communications regulation information on theItrel®EZ™ Model 7434A Patient Programmer.FCC ID: LF57434AThis device complies with Part 15 Rules. Operation is subject tothe following two conditions: (1) this device may not causeharmful interference and (2) this device must accept anyinterference received, including interference that may causeundesired operation.IMPORTANT: Changes or modifications to this product not authorized byMedtronic, Inc., could void the FCC Certification and negate yourauthority to operate this product.9900213EN/197877_001/ccs 1/29/01 2:18 PM Page vi
ABOUT THIS BOOKLETFor over 30 years, stimulation has helped thousands of patientsmanage their pain. This has also improved their quality of life.Your stimulation system may be used with other pain treatmentslike physical therapy or medicine. Stimulation will not cure yourpain. It may, however, reduce your pain to a tolerable level. As aresult, you may be able to resume your daily activities.19900213EN/197877_001/ccs 1/29/01 2:18 PM Page 1
This booklet provides you with the following:• Indications, contraindications, warnings, precautions, risks ofsurgery, possible side effects, changes in therapy, and possibledevice complications• What to expect as you recover from surgery• Definition of pain and stimulation• Description of your implanted system and how it works tomanage your pain• Description of your patient programmer, and how to use it andcare for it• Steps to take to help you solve problems or identify when youshould call your doctor • How to live with your stimulation system• Answers to common questions• Important terms that appear as bold in text; these terms arelisted in the Glossary at the end of this booklet.Ask your doctor to explain anything that is unclear.29900213EN/197877_001/ccs 1/29/01 2:18 PM Page 2
INTRODUCTIONIndicationsThe Medtronic®Itrel®3 System is indicated as an aid in themanagement of chronic, intractable pain of the trunk or limbs.Patients should be carefully selected to assure that their pain is ofphysiologic origin. Also, patients must be appropriate candidatesfor surgery.7CautionAll other uses remain investigational.ContraindicationsImplantation of an Itrel 3 System is contraindicated for:• Patients for whom trial stimulation is unsuccessful.• Patients who are unable to properly operate the system.39900213EN/197877_001/ccs 1/29/01 2:18 PM Page 3
WarningsCase Damage—If the neurostimulator case is pierced, severe burnscould result.Equipment Operation—Do not use potentially dangerousequipment (cars, power tools, etc.) when your neurostimulator ison. What may feel like a sudden increase in stimulation (“jolt“ or“shock“) could cause you to lose control of the equipment you areusing. Turn the neurostimulator off and set the amplitude to thelowest setting.Postural Changes—As your spine moves, you may sense anincrease or decrease in the stimulation. It may seem as though theneurostimulator is turning on or off. When you bend over or movesuddenly, you may even feel an uncomfortable “jolt“ or “shock.“Pregnancy—Safety for use during pregnancy or delivery has notbeen established.49900213EN/197877_001/ccs 1/29/01 2:18 PM Page 4
Theft Detectors and Screening Devices—Use care whenapproaching theft detectors and security arches (such as thosefound in airports, libraries, and some department stores) as thesedevices can cause momentary, uncomfortable, or painfulstimulation. Similarly, avoid airport security wands.When approaching these devices do the following:1. Show your patient identification card to security staff. Ask thatyou be allowed to bypass the security device, request a handsearch, or ask that the security device be turned off.2. If passing through the security device is unavoidable, turn theneurostimulator off.3. Reduce the amplitude to the lowest setting.4. Approach the security device slowly. If any stimulation is felt,back out of the security device immediately without changingbody position. If no stimulation is felt, move quickly throughto the other side.59900213EN/197877_001/ccs 1/29/01 2:18 PM Page 5
PrecautionsPatient Management—To ensure the most benefit from yoursystem, regular appointments with your doctor are recommended.Medical Procedures—Some medical procedures can damage theneurostimulation system or can cause changes to the system whichmay produce discomfort, pain, or injury. Consult your doctorabout risks and benefits of procedures such as:• Electrosurgery (surgery performed using electrical methods)• Diathermy (heat treatment)• Lithotripsy (the crushing of a blockage within the urinary tractusing electrical methods)• Radiation therapy (that is, cancer treatment)• Magnetic resonance imaging (MRI)—not recommended• Defibrillation (electric shock to the heart)69900213EN/197877_001/ccs 1/29/01 2:18 PM Page 6
Electromagnetic Interference (EMI)—Strong electrical fields, suchas those produced by radio towers or some industrial equipment,can affect the function of your neurostimulator. This can causeuncomfortable stimulation (a “jolt“ or “shock“). This problem iscalled electromagnetic interference, or EMI.High/Low Pressure Effects—The effects of high/low pressure(that is, scuba diving, unpressurized airplanes) on patients with animplanted neurostimulation system are unknown.79900213EN/197877_001/ccs 1/29/01 2:18 PM Page 7
Home Appliances—Be sure that appliances and equipment areproperly installed and in good working condition before usingthem.Occupational Environments—Strong interference could causeyour neurostimulator to deliver inappropriate or additionalstimulation to your spinal cord. Turning the neurostimulator offmay reduce the effect of interference. Devices or equipment toavoid are theft detectors, airport/security screening devices,electric arc welding equipment, electric substations and powergenerators, CB or ham radio antennas, electric induction heatersused in industry to bend plastic, TV/radio transmitting towers, orelectric steel furnaces.89900213EN/197877_001/ccs 1/29/01 2:18 PM Page 8
Risks of SurgeryImplanting the Itrel 3 System has the same risks as any otherneurostimulation implant procedure. These risks include:• Spinal fluid leak, headache• Fluid collection (seroma) or bruising (hematoma) at theneurostimulator site• Bleeding near the spinal cord (epidural hemorrhage orhematoma) or paralysis• Infection99900213EN/197877_001/ccs 1/29/01 2:18 PM Page 9
Possible Side EffectsSide effects of spinal cord stimulation are usually mild and goaway when stimulation is turned off. Possible side effects include:• Chest wall stimulation• Uncomfortable stimulation• Jolting or shocking sensation• Pain at the surgery sitesChanges in TherapyThere may be changes in the level of your pain control over time.In most cases, your doctor can correct these changes withoutsurgery. However, it is possible that surgery may be required.109900213EN/197877_001/ccs 1/29/01 2:18 PM Page 10
Possible Device Complications• There may be pain, redness, or swelling at the neurostimulatorsite more than 6 weeks after surgery.• The lead may move; surgery may be needed to reposition thelead.• The system may wear through your skin; this can cause aninfection or scarring.• Pain control may decrease or stop due to device problems. Oneexample is the lead or extension wires could break.Note: Do not twist or turn the system through your skin;this can disconnect or damage the system.• Your body may have an allergic response to implantedmaterials.119900213EN/197877_001/ccs 1/29/01 2:18 PM Page 11
RECOVERING FROM SURGERYHealingIt takes several weeks to heal from surgery. You will feel somediscomfort from the incision(s). You will also have some pain atthe neurostimulator site for 2 to 6 weeks. This pain is normal.Physical Therapy and MedicationsYour physician may also prescribe physical therapy, medication, orboth to help manage your pain. Always follow your doctor’sinstructions for the therapy(ies) prescribed.129900213EN/197877_001/ccs 1/29/01 2:18 PM Page 12
ActivitiesDuring your recovery (about 6 weeks), follow your doctor’sadvice. Avoid activities where you must bend, stretch, or twistyour body; this can move your lead and alter your stimulation.To prevent lead movement, AVOID the following activities duringyour recovery:• Lying on your stomach• Reaching over your head• Turning from side to side• Bending forward, backward, or from side to side• Lifting more than 5 pounds139900213EN/197877_001/ccs 1/29/01 2:18 PM Page 13
As you begin to feel better, you should be able to return toactivities such as:• Bathing or showering• Sexual activity• Working at home or at your business• Hobbies or other activities such as walking, gardening, cycling,or swimming• TravelingDiscuss any type of strenuous activity with your doctor first, toavoid any possible damage to your system. Remember thatreturning to your daily activities should make you feel better,not worse.Note: As you adjust to life with better pain control, youmay want to try activities that you could not perform beforeyour surgery. Discuss this with your doctor first.149900213EN/197877_001/ccs 1/29/01 2:18 PM Page 14
WHAT IS PAIN?Nerve signals from all over your body travel to your spinal cord,and then to your brain. Your brain translates nerve signals intofeelings such as pressure, itching, tingling, or pain. It is your brainthat feels pain, not the area of your body where the signal started. WHAT IS STIMULATION AND HOW DOES ITMANAGE PAIN?Stimulation delivers tiny electrical pulses to the spinal cord. Thisblocks the pain signal as it travels to the brain. If the signal doesnot reach the brain, the pain is not “felt.“Note: Stimulation will not cure your pain nor will it blocksharp pain caused by a recent injury. 159900213EN/197877_001/ccs 1/29/01 2:18 PM Page 15
16Stimulation blocks pain signals as they move to the brain.Pain signalmoving to brain is blocked bystimulationPain signal ismoving to brainfrom painful foot9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 16
WHAT DOES YOUR STIMULATION SYSTEM LOOK LIKE?A typical stimulation system has three implanted parts: oneneurostimulator, one lead, and one extension.Neurostimulator: The neurostimulator is the power source of yoursystem. It contains a special battery and electronics to control thestimulation you feel.Note: In time, the battery inside your neurostimulator willwear out. When this occurs, your neurostimulator will needto be surgically replaced.Lead: The lead (pronounced “leed“) is a thin wire covered with aprotective coating. The lead has small metal electrodes near thetip. The lead is surgically placed with the metal electrodes nearyour spinal cord. The electrodes transmit tiny electrical pulses tothe area where your pain signals will be blocked.179900213EN/197877_001/ccs 1/29/01 2:18 PM Page 17
Extension: The extension is a thin wire placed under the skin. Italso is covered with a protective coating. The extension connects tothe neurostimulator at one end and to the lead at the other end. The parts of your stimulation system.18ExtensionNeurostimulatorLeadElectrode9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 18
HOW DOES YOUR STIMULATION SYSTEM WORK?After your surgery, your doctor used a physician programmer (asmall computer) to send stimulation instructions to yourneurostimulator. These instructions control the stimulation youfeel. The instructions are stored in your neurostimulator. If needed,your doctor can use the programmer to change the instructions.You have been given a patient programmer to use with yoursystem. It allows you to turn your neurostimulator on and off. Italso allows you to fine tune your stimulation. Your doctor or nursewill explain how to use the patient programmer. Refer to “Usingthe Patient Programmer,“ on page 41. 199900213EN/197877_001/ccs 1/29/01 2:18 PM Page 19
An optional control magnet can also be used to turn yourneurostimulator on and off. This magnet can also be used to start adosage of stimulation if programmed by your doctor. You cannotuse the control magnet to adjust amplitude. If necessary, your doctor can disable the circuit that allows on/offcontrol with the magnet.A special code inside your neurostimulator allows onlyprogramming from the physician or patient programmer; otherdevices, such as the control magnet, are not able to program yourneurostimulator.209900213EN/197877_001/ccs 1/29/01 2:18 PM Page 20
Neurostimulator controlling devices.21Itrel®EZ™PatientProgrammer ControlMagnet9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 21
HOW DOES STIMULATION FEEL?Your neurostimulator sends tiny electrical pulses through theextension to the lead. The electrical pulses move through the leadand electrodes to the area where your pain signals will be blocked.To most patients, these pulses feel like tingling in the pain area.Sensations vary from patient to patient. When your neurostimulator is turned on, the tingling slowlyincreases until it levels off. When your neurostimulator is turnedoff, the tingling slowly decreases until it stops.229900213EN/197877_001/ccs 1/29/01 2:18 PM Page 22
Stimulation feels like tingling in the area of pain.23PainfulAreaStimulationArea9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 23
As your spine moves, you may sense an increase or decrease in thestimulation. It may seem as though the neurostimulator is turningon or off. When you bend over or move suddenly, you may evenfeel an uncomfortable “jolt“ or “shock.“Do not be alarmed if these sudden changes in stimulation occur.The instructions inside your neurostimulator have not changed.Your movement has probably caused your spinal cord to movecloser to or farther from the lead electrodes. For a moment, thestimulation may feel more or less intense than it should. Sudden changes in stimulation like these are most common duringthe recovery period. They usually decrease as you heal and thelead becomes more secure in your spinal column.249900213EN/197877_001/ccs 1/29/01 2:18 PM Page 24
HOW IS YOUR ITREL®3 SYSTEM IMPLANTED?Implantation of your Itrel®3 System has four basic steps andusually is done in one or two operations. The four steps are asfollows:• Lead placement• Screening• Neurostimulator internalization• Neurostimulator programmingDuring the lead placement, you may be under a local anesthetic.The doctor will ask you to help determine when the lead is in thecorrect place. You will know the lead is correctly placed when youfeel a tingling sensation in the area of your pain. This is thesensation you will feel instead of pain when your Itrel®3 System isblocking pain.259900213EN/197877_001/ccs 1/29/01 2:18 PM Page 25
An external “screener“ device provides the energy for the trialstimulation during the lead placement. If your doctor chooses tointernalize the system in one operation., the neurostimulator isimplanted after a successful lead placement.If the procedure is done in two operations, you will have a trialscreening period of several days. Your doctor will use the“screener“ to determine the most comfortable and effectivestimulation settings for you.269900213EN/197877_001/ccs 1/29/01 2:18 PM Page 26
The neurostimulator is internalized while you are under local orgeneral anesthesia. This will occur after the screening period or, aspreviously explained, immediately after the lead placement. Thedoctor makes an incision in the skin, usually in the abdomen.The neurostimulator is usually placed in the abdomen.27NeurostimulatorExtensionLead9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 27
The neurostimulator is placed under the skin. The lead is thenconnected to the neurostimulator via the extension (wire). Yourdoctor will try to place the neurostimulator in an area that is mostcomfortable and cosmetically acceptable.After the internalization, your doctor will use the physicianprogrammer to program the neurostimulator to the therapysettings that are appropriate to your needs. Your doctor may alsochoose to program a SoftStart™/Stop stimulation. The SoftStart is afeature that gradually increases the amplitude from zero (0) to theprogrammed amplitude when your neurostimulator is turned on.When you turn off the neurostimulator, SoftStop graduallydecreases the amplitude to zero (0) before turning off.289900213EN/197877_001/ccs 1/29/01 2:18 PM Page 28
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WHAT DOES THE PATIENT PROGRAMMER DO?Use the patient programmer only with your implantedneurostimulator. DO NOT use the programmer on other devices(such as a cardiac pacemaker). 7WarningSignals (telemetry) from the patient programmer may disrupt the functionof other implanted devices.Your programmer is easy to use. You can use it to: • Turn the neurostimulator on or off.• Adjust the stimulation of your neurostimulator.• Check the status of the neurostimulator battery and the programmer battery.• Confirm that the neurostimulator has received instructionsfrom the programmer.309900213EN/197877_001/ccs 1/29/01 2:18 PM Page 30
HOW DOES THE PATIENT PROGRAMMERWORK?The patient programmer sends signals to your neurostimulator.These signals tell the neurostimulator to turn on or off or tochange stimulation.The neurostimulator also sends signals to the patient programmer.Signals from the neurostimulator confirm changes you have made.Signals also tell you the status of the neurostimulator battery.The programmer placed over the neurostimulator.31Location of Neurostimulator9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 31
PATIENT PROGRAMMER FEATURESThis section describes the features of the patient programmer. The patient programmer.32KeypadBattery CoverBattery CoverRelease Tab9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 32
KeypadThe keypad has 4 keys: Neurostimulator On and Off keys,and Increase and Decrease keys.The keypad.33Turns neurostimulator offIncrease andDecrease Keys Turns neurostimulator on9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 33
On and Off KeysPress the On and Off keys to turn the neurostimulator onand off. Increase and Decrease KeysAStimulation Control switch, under the battery cover, is used toselect the amplitude, rate, or pulse width. (See page 79 forinformation on removing the battery cover.) Press the Increase and/or Decrease key to adjust the amplitude, rate, or pulsewidth within ranges set by your doctor.349900213EN/197877_001/ccs 1/29/01 2:18 PM Page 34
Control SwitchesThe control switches and battery are located under the battery cover.For instructions on removing the battery cover, refer to page 79.Control switches and battery.+lSN9V IEC-6LR6135Stimulation Control Switch(Rate is selected)Beeper Volume Control Switch(High volume is selected)Amplitude Rate PulseWidthOff Low HighBattery9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 35
Stimulation Control SwitchDepending on the instructions your doctor has programmed intoyour neurostimulator, you can adjust some or all of these settingswith the Stimulation Control switch: amplitude, rate, and pulsewidth. Colors and symbols identify each setting (see below).Changing these settings will help you find the highest level ofcomfort and pain relief.The amount or “volume“(strength or intensity)of stimulation required to mask your pain.This is the setting most often adjusted by patients.The number of pulses per second; rate feels like “tapping.“The length or duration of the electrical pulse. A longer pulse covers a larger area. Note: The Increase and Decrease keys on your keypadadjust the selected stimulation control.36Pulse Width RateAmplitude 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 36
Beeper Volume Control SwitchThe programmer beeps each time a change is received by yourneurostimulator. Turn the beeper Off or set the volume to Lowor High with the Beeper Volume Control switch.(See Table 1.)Table 1. Beeper description.If you hear It meansOne beep You have pressed the On/Off or Increase/Decreasekey and the change was successfully received byyour neurostimulator. Three rapid beeps You tried to adjust the amplitude, pulse width, or rate beyond the highest and lowest settings.You tried to increase amplitude, rate, or pulsewidth with the neurostimulator turned off.You pressed On while your neurostimulator was in “dose lockout.“ Some patients’ doctors set a lockout period during which no stimulation is delivered. You cannot adjust stimulation during the lockout.379900213EN/197877_001/ccs 1/29/01 2:18 PM Page 37
Symbols and Status LightsThe back of your programmer displays symbols and status lights.These will help you during a programming session.SymbolsA positioning symbol helps you align your programmer over theneurostimulator.An antenna symbol directs you to the detachable antennaconnector. An optional, detachable antenna can be plugged inhere.Status LightsWhen lit or blinking, the status lights tell you the following:• Whether the neurostimulator is on or off• The neurostimulator battery status • The programmer battery status389900213EN/197877_001/ccs 1/29/01 2:18 PM Page 38
Symbols and status lights on the back of the patient programmer.Medtronic® Itrel® EZ™Model 7434A9V39GreenProgrammerBattery LightGreenNeurostimulator“On“ LightGreenNeurostimulatorBattery LightYellowNeurostimulator“Off“ LightDetachableAntennaSymbol PositioningSymbol9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 39
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USING THE PATIENT PROGRAMMERThis section is organized as follows:• Placing the Programmer over the Neurostimulator• Checking the Neurostimulator Battery• Turning the Neurostimulator On and Off• Adjusting Your StimulationPlacing the Programmer over the NeurostimulatorLocate the neurostimulator implanted under your skin and holdthe programmer over it. Hold the programmer flat against yourskin or clothing so that the keypad is directly over yourneurostimulator. To send and receive signals, hold theprogrammer steady over the neurostimulator for at least 1 secondwhile you press any key. When you align the programmercorrectly over the neurostimulator, two or more lights will shine. 419900213EN/197877_001/ccs 1/29/01 2:18 PM Page 41
If the beeper is on, it will beep.The lights and beeper tell you that you have lined up theprogrammer and neurostimulator and they are sending signals toeach other. If only the programmer battery light is lit and the beeper does not beep, move the programmer an inch or two andtry again.42Note: A detachableantenna is also available.This is helpful for patientswho cannot reach theirneurostimulator. Refer to“Accessories“ on page 65for more information.Position the programmer over theneurostimulator. (Place against clothing or skin.)9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 42
Checking the Neurostimulator BatteryThe Neurostimulator Battery light on the back of the programmertells you the status of your neurostimulator battery.See page 112 for information on what to do when your batteryruns down.To check the neurostimulator battery:1. Place the programmer over your neurostimulator. Hold theprogrammer flat against your skin or clothing so that thekeypad is directly over your neurostimulator.2. If your neurostimulator is off, press the Off key. If yourneurostimulator is on, press the On key. Hold the programmerover the neurostimulator for at least 1 second.3. Confirm that the green Neurostimulator Battery light on theback of the programmer is lit. Refer to Table 2 for moreinformation about the Neurostimulator Battery light. 439900213EN/197877_001/ccs 1/29/01 2:18 PM Page 43
44Note: Move indoors or into the shade if sunlight dimsthe programmer lights.Table 2. Neurostimulator Battery lights.When this happens It MeansGreen Neurostimulator Battery light Neurostimulator battery is OK.is on for 8 seconds after pressing any key.Green Neurostimulator Battery light The neurostimulator battery is low. is blinking for 8 seconds after Call your doctor’s office.pressing any key.Green Neurostimulator Battery light Reposition programmer and try again.is off after pressing any key. Interference from electrical equipmentcan cause lights to remain off. Move toanother room and try again.If the light remains off, the neurostimu- lator battery may need to be replaced.The neurostimulator should be reviewed with a physician programmer.Contact your doctor immediately.9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 44
Turning the Neurostimulator On and OffTurn your neurostimulator on when:• You require pain relief, or• You want to adjust the amplitude, rate, or pulse width.Turn your neurostimulator off when:• The amplitude is set at the lowest setting and you do not needstimulation.• You are using equipment that could be harmful to you orothers if you should receive a sudden shock (for example,driving a car). • You are having a medical or dental procedure. See“Precautions,” page 6.• You are passing though a theft detector or a security devicesuch as those used in department stores and airports.459900213EN/197877_001/ccs 1/29/01 2:18 PM Page 45
Notes: • Turning the neurostimulator off extends the battery life ofyour neurostimulator. When the battery wears out, theneurostimulator must be surgically replaced. You will wantto make it last as long as possible. • Decreasing the amplitude to the lowest setting will not turnoff the neurostimulator. 7CautionTo avoid unpleasant stimulation, always decrease the amplitude to thelowest setting:• After turning your neurostimulator off.• Before adjusting the rate or pulse width of your neurostimulator. After rate or pulse width are set, slowly increase the amplitude to your comfort level.469900213EN/197877_001/ccs 1/29/01 2:18 PM Page 46
To turn the neurostimulator on:1. Place the programmer over your neurostimulator. Hold theprogrammer flat against your skin or clothing so that thekeypad is directly over your neurostimulator.Place the programmer over the neurostimulator.2. Press the Neurostimulator On key and hold the programmerover the neurostimulator for 1 second. If the beeper is on, youshould hear one beep to confirm that a change has occurred.47Location ofNeurostimulator9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 47
Press the Neurostimulator On key.3. Check that the green Neurostimulator On light on the back ofthe programmer is lit; this indicates that the neurostimulatorwas successfully turned on (see Table 3). This light stays on for 8 seconds after you release the key.Note: The neurostimulator will turn on with the settingslast programmed. 489900213EN/197877_001/ccs 1/29/01 2:18 PM Page 48
To turn the neurostimulator off:1. Place the programmer over your neurostimulator. Hold theprogrammer flat against your skin or clothing so that thekeypad is directly over your neurostimulator.Place the programmer over the neurostimulator.2. Press the Neurostimulator Off key and hold the programmerover the neurostimulator for 1 second. If the beeper is on, youshould hear one beep to confirm that a change has occurred. 49Location ofNeurostimulator9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 49
Press the Neurostimulator Off key.3. Check that the yellow Neurostimulator Off light on the back ofthe programmer is lit; this indicates that the neurostimulatorwas successfully turned off (see Table 3). This light stays on for8 seconds after you release the key.Note: Move indoors or into the shade if sunlight dims theprogrammer lights.509900213EN/197877_001/ccs 1/29/01 2:18 PM Page 50
4. Decrease the amplitude to the lowest setting (refer to pages 56 -57 for instructions).7CautionTo avoid unpleasant stimulation, always decrease the amplitude to thelowest setting after turning your neurostimulator off.Table 3. Neurostimulator On and Off lights.When It MeansThe green Neurostimulator On light is lit Neurostimulator is on.for 8 seconds after pressing any key.The yellow Neurostimulator Off light is lit Neurostimulator is off.for 8 seconds after pressing any key.Neither Neurostimulator On nor Off The programmer does not know light is lit after pressing any key. if the neurostimulator is on or off because it failed to communicate with the neurostimulator.Refer to “Troubleshooting,“ page 96.519900213EN/197877_001/ccs 1/29/01 2:18 PM Page 51
52Adjusting Your StimulationTable 4 provides some general guidelines for when you shouldadjust your stimulation. Your doctor will provide more completeguidelines.Table 4. When to adjust your stimulation.Adjust the Amplitude Press This KeyBefore you adjust rate or pulse widthAfter you turn the neurostimulator off When the tingling is not strong enough When the tingling is too strongAdjust the Pulse Width Press This KeyIf the tingling does not cover your pain areaIf the tingling seems to cover too much areaAdjust the Rate Press This KeyIf the tapping is uncomfortable9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 52
Programming TipsThe following tips are helpful when using the patient programmer.7CautionTo avoid unpleasant stimulation, always decrease the amplitude to thelowest setting:• After turning your neurostimulator off.• Before adjusting the rate or pulse width of your neurostimulator. After rate or pulse width are set, slowly increase the amplitude to your comfort level.• Always set your neurostimulator to the lowest settings thatprovide pain relief. The higher the settings, the faster yourneurostimulator battery will wear out. When the batterywears out, the neurostimulator must be surgically replaced.You will want to make it last as long as possible.• Select amplitude, rate, or pulse width using the StimulationControl switch. The Increase and Decrease keys willadjust the stimulation setting that you select.539900213EN/197877_001/ccs 1/29/01 2:18 PM Page 53
• The neurostimulator must be on to increase amplitude, rate,and pulse width. However, the neurostimulator may be eitheron or off to decrease the amplitude, rate, or pulse width. • Use the lights on the back of the programmer to confirm that achange is taking place. The Neurostimulator On or Off lights,the Programmer Battery light, and the Neurostimulator Batterylight should be lit after sending a change to theneurostimulator. This confirms that the neurostimulator isturned on or off, and that the neurostimulator and theprogrammer batteries are OK. These lights stay on for 8 seconds after you release the key.549900213EN/197877_001/ccs 1/29/01 2:18 PM Page 54
• If the beeper is on, the programmer will beep once for eachchange that is programmed into your neurostimulator. Yourprogrammer will beep three times if you try to increase astimulation setting when the neurostimulator is off. It will alsobeep three times if you have reached the lowest or highestvalue for the selected setting (amplitude, rate, or pulse width).The programmer will beep three times if you press On while thesystem is in “dose lockout.“• You can increase or decrease settings more quickly by pressingand holding down the desired key. Every second, theprogrammer will send a change to the neurostimulator. 559900213EN/197877_001/ccs 1/29/01 2:18 PM Page 55
Decreasing the Amplitude to the Lowest SettingAlways decrease the amplitude to the lowest setting beforeadjusting pulse width and rate or after turning yourneurostimulator off.1. Remove the battery cover. (Refer to “Removing the BatteryCover,” page 79.)2. Move the Beeper Volume Control switch to Low or High .3. Move the Stimulation Control switch to amplitude .Move the Stimulation Control switch to amplitude.R61569900213EN/197877_001/ccs 1/29/01 2:18 PM Page 56
574. Place the programmer over your neurostimulator. Hold theprogrammer flat against your skin or clothing so that thekeypad is directly over your neurostimulator.5. Press and hold the Decrease key until the programmer beepsrapidly three times. This reduces the amplitude to the lowestsetting.Note: The neurostimulator may be on or off whendecreasing amplitude.6. Replace the battery cover. (Refer to “Replacing the BatteryCover,” page 80.)Adjusting the Pulse Width1. Remove the battery cover. (Refer to “Removing the BatteryCover,” page 79.)2. Decrease the amplitude to the lowest setting as described onpage 56.9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 57
7CautionTo avoid unpleasant stimulation, always decrease the amplitude to thelowest setting before adjusting the pulse width or rate of yourneurostimulator. After rate or pulse width is set, slowly increase theamplitude to your comfort level.3. Move the Stimulation Control switch to pulse width .Move the Stimulation Control switch to pulse width.61589900213EN/197877_001/ccs 1/29/01 2:18 PM Page 58
4. Place the programmer over your neurostimulator. Hold theprogrammer flat against your skin or clothing so that thekeypad is directly over your neurostimulator.5. Press Neurostimulator On to turn on the neurostimulator.6. Press the Increase or Decrease key to make a change. 7. Move the Stimulation Control switch to amplitude .8. Place the programmer over your neurostimulator. Hold theprogrammer flat against your skin or clothing so that thekeypad is directly over your neurostimulator.9. Press the Increase key to assess the change. Repeat steps 2through 9 until the change is acceptable.10. Replace the battery cover. (Refer to “Replacing the BatteryCover,” page 80.)599900213EN/197877_001/ccs 1/29/01 2:18 PM Page 59
Adjusting the Rate1. Remove the battery cover. (Refer to “Removing the BatteryCover,” page 79.)2. Decrease the amplitude to the lowest setting as described onpages 56 - 57.7CautionTo avoid unpleasant stimulation, always decrease the amplitude to thelowest setting before adjusting the pulse width or rate of yourneurostimulator. After rate or pulse width is set, slowly increase theamplitude to your comfort level.3. Move the Stimulation Control switch to rate .Move the Stimulation Control switch to rate.61609900213EN/197877_001/ccs 1/29/01 2:18 PM Page 60
4. Place the programmer over your neurostimulator. Hold theprogrammer flat against your skin or clothing so that thekeypad is directly over your neurostimulator.5. Press Neurostimulator On to turn on the neurostimulator.6. Press the Increase or Decrease key to make a change. 7. Move the Stimulation Control switch to amplitude .8. Place the programmer over your neurostimulator. Hold theprogrammer flat against your skin or clothing so that thekeypad is directly over your neurostimulator.9. Press the Increase key to assess the change. Repeat steps 2through 9 until the change is acceptable.10. Replace the battery cover. (Refer to “Replacing the BatteryCover,” page 80.)619900213EN/197877_001/ccs 1/29/01 2:18 PM Page 61
Adjusting the Amplitude1. Remove the battery cover. (Refer to “Removing the BatteryCover,” page 79.)2. Move the Stimulation Control switch to amplitude .Move the Stimulation Control switch to amplitude.LR61629900213EN/197877_001/ccs 1/29/01 2:18 PM Page 62
3. Place the programmer over your neurostimulator. Hold theprogrammer flat against your skin or clothing so that thekeypad is directly over your neurostimulator.4. Press Neurostimulator On to turn on the neurostimulator.5. Press the Increase or Decrease key to make a change. 6. Replace the battery cover. (Refer to “Replacing the BatteryCover,” page 80.)639900213EN/197877_001/ccs 1/29/01 2:18 PM Page 63
649900213EN/197877_001/ccs 1/29/01 2:18 PM Page 64
ACCESSORIESWrist Strap and Carrying CaseA wrist strap is packaged with the patient programmer and can beused to help you avoid dropping it. The wrist strap is attachednear the battery cover release tab. A carrying case is also enclosedwith the programmer. Store the patient programmer in thecarrying case to protect it.659900213EN/197877_001/ccs 1/29/01 2:18 PM Page 65
Location of the wrist strap attachment.66Wrist StrapAttachmentWristStrap9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 66
Detachable AntennaA detachable antenna is available for patients who cannot reachtheir neurostimulator. The patient programmer can be used toprogram the neurostimulator as previously described. Whenconnected, the detachable antenna turns off the programmer’sinternal antenna.7CautionDo not attach the antenna over your neurostimulator incision using theadhesive discs until the incision heals.Note: When the detachable antenna is not used, keep therubber plug in the antenna connector of the patientprogrammer. The rubber plug helps keep water out of theprogrammer. 679900213EN/197877_001/ccs 1/29/01 2:18 PM Page 67
To keep the antenna in place, use the adhesive discs supplied withthe antenna. The adhesive discs are hypoallergenic. This helpsreduce the chance of irritation. If irritation occurs, consult yourdoctor.Replace the adhesive discs every day. Before replacing an old discwith a fresh one, clean your skin using an antibacterial soap anddry thoroughly.689900213EN/197877_001/ccs 1/29/01 2:18 PM Page 68
Attaching the Antenna over the Neurostimulator1. Remove adhesive disc from square sheet.2. Attach disc to antenna coil. Remove protective covering.69AdhesiveDiscAntennaCoilAdhesiveDisc9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 69
Note: The antenna must be properly lined up over theneurostimulator for programming to occur. Theprogrammer’s internal antenna is disabled when theantenna is properly connected.4. Press antenna firmly inplace.3. Position antenna overneurostimulator asshown.70NeurostimulatorAntenna9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 70
Connecting the Antenna to the Patient Programmer1. Pull out the rubber plug on the patient programmer to revealthe antenna connector. Note: The antenna connector is located on the end of theprogrammer near the keypad.2. Insert the antenna’s metal plug into the antenna connector andpush the metal plug until it fits securely into place. Disconnecting the Antenna1. Grasp the plug and pull it straight out. Do not pull on the cablebecause this may break the wires. 2. Insert the rubber plug into the antenna connector.Note: Keep the rubber plug in the antenna connector whennot in use; this helps keep water out of the programmer.719900213EN/197877_001/ccs 1/29/01 2:18 PM Page 71
The detachable antenna and patient programmer.72RubberPlugAntennaConnectorAntennaMetalPlugKeypad9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 72
Caring for the AntennaIf you use the detachable antenna, you should wash it daily withmild soap and water.Note: Do not allow the metal plug end of the cord to getwet.1. Disconnect the antenna from the programmer before cleaning.2. Wash the antenna with mild soap and water. 3. Rinse the antenna. Make sure no soap remains on it. 4. Dry the antenna with a clean towel immediately after washing. Note: When not in use, store the antenna in a plastic bag toprotect it from dust.739900213EN/197877_001/ccs 1/29/01 2:18 PM Page 73
Caring for Your SkinSkin may become irritated from the pressure of the antenna orfrom an allergic reaction to the adhesive used to hold the antennain place. Therefore, it is very important to keep the skin in thisarea clean and dry. Inspect the area every day to see that the skinremains healthy.7CautionIf you notice swelling or redness in the area where you place the antenna,contact your doctor before using the antenna again.Clean the skin over the neurostimulator with an antibacterial soapand change the antenna adhesive discs daily. If the discs irritate your skin, you may want to wear a soft, snug-fitting undergarment to protect your skin and then tape theantenna to the outside of the undergarment.749900213EN/197877_001/ccs 1/29/01 2:18 PM Page 74
Using Your Control Magnet (Optional)By briefly applying and then removing the optional controlmagnet over your neurostimulator, you can turn it on or off. Thisfeature can be disabled by your doctor, however. If it is disabled,the magnet will not turn the neurostimulator on or off.Your implant site and the final placement of your neurostimulatorcan vary from the examples shown in the following instructions.Have your doctor show you how to locate or position the magneton your neurostimulator so that it is centered as shown in thefollowing figure.Magnet properly centered over neurostimulator. 75NeurostimulatorControlMagnet9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 75
To turn the neurostimulator on or off, follow these steps:Step 1. Grasp the magnet with the flat end away from you.Step 2. Press the flat end of the magnet directly over and along thelength of the neurostimulator.769900213EN/197877_001/ccs 1/29/01 2:18 PM Page 76
Step 3. Hold the magnet steady for 1 to 2 seconds.Step 4. Remove the magnet.If the magnet fails to turn the neurostimulator on or off, repeat steps 3 and 4, holding the magnet against the neurostimulator in adifferent position. Try a “1 o’clock“ or “4 o’clock“ position. 1 o’clock position 4 o’clock position779900213EN/197877_001/ccs 1/29/01 2:18 PM Page 77
If your doctor has programmed the neurostimulator with theSoftStart™/Stop feature, the magnet will automatically start theincrease or decrease. If the neurostimulator has been programmedwith a dosage of stimulation, the magnet will start the dose. Note: Allow a few seconds for the SoftStart circuit to raisethe amplitude to the point where you can feel it.If your doctor has programmed the neurostimulator with thecycling feature and you use your magnet (or patient programmer)to turn off the neurostimulator, your therapy will then stop. Whenyou reapply the magnet to turn on the neurostimulator again, yourtherapy always starts at the beginning of the On cycle. 789900213EN/197877_001/ccs 1/29/01 2:18 PM Page 78
79CARING FOR YOUR PATIENT PROGRAMMERBattery CoverWhen the battery cover is removed, you can replace the battery oraccess the Stimulation Control switch.Removing the Battery Cover1. Hold the programmer with one hand.2. Lift the battery cover release tab on the end of the programmer.Lift off the cover.Remove the battery cover.Release Tab9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 79
Replacing the Battery Cover1. Place the center hook on the edge of the cover into the centerslot in the programmer.2. Lower the battery cover.3. Press down the end of the cover to lock it in place.Replace the battery cover.809900213EN/197877_001/ccs 1/29/01 2:18 PM Page 80
Identification LabelYour patient programmer comes with an identification label. 1. Fill in the label (name, phone number, etc.) with permanentink.2. Peel off the backing and stick the label to the inside of thebattery cover.Note: Do not place the label over the ridges on the batterycover.819900213EN/197877_001/ccs 1/29/01 2:18 PM Page 81
Placement of the identification label in the battery cover.82InsideBatteryCoverReleaseTabPlace Label HereIdentification Label9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 82
Checking the Programmer BatteryA 9-volt battery provides the power for the patient programmer.Use an alkaline battery for best performance and economy.Notes: • When not using the programmer for more than 4 weeks,remove the battery to prevent possible damage to the devicedue to battery leakage.•Make sure that you always have a fresh 9-volt battery so that you can turn your neurostimulator on and off or adjust the stimulation settings when necessary.• Do not use a rechargeable or zinc-air battery. Theprogrammer is designed to indicate its battery status with analkaline battery installed; other battery types may not giveaccurate indications of the programmer’s battery status.The Programmer Battery light is located on the back of theprogrammer. It tells you the status of your programmer battery.9V839900213EN/197877_001/ccs 1/29/01 2:18 PM Page 83
To check the programmer battery: Press any key on the patientprogrammer keypad. The green Programmer Battery light willrespond. Refer to Table 5 for more information about theProgrammer Battery light.Table 5. Programmer Battery light.When It MeansGreen Programmer Battery Programmer battery is OK.light is on for 8 seconds afterpressing any key.Green Programmer Battery light Programmer battery is low. is blinking after pressing Replace with new 9-volt any key. battery.Green Programmer Battery light Replace with new 9-volt is off after pressing any key. battery.9V849900213EN/197877_001/ccs 1/29/01 2:18 PM Page 84
Removing the Battery1. Remove the battery cover. (Refer to “Removing the BatteryCover,” page 79.)2. Place one finger on the edge of the battery between the Controlswitches.3. Lift the battery out of the compartment without using excessiveforce.Remove the battery.SN+859900213EN/197877_001/ccs 1/29/01 2:18 PM Page 85
Installing the BatteryAn alkaline battery is recommended for longer battery life.1. Remove the battery cover (refer to page 79) and the old battery(refer to page 85), if necessary.2. Check the battery label for positive [+] and negative [-]contacts. Match them with the [+] and [-] symbols in thebattery compartment.3. Press the battery down fully into the battery compartmentwithout using excessive force.Notes: • Do not press any of the programmer’s keys during batteryinsertion.• The programmer performs a self-test when the battery isinserted. A successful check is indicated by a single flash ofthe status lights followed by a short beep. If this does notoccur, the self-test has failed. Refer to “Troubleshooting,“page 96. 869900213EN/197877_001/ccs 1/29/01 2:18 PM Page 86
4. Replace the battery cover. (Refer to “Replacing the BatteryCover,” page 80.)Install the battery.SN+3.2.879900213EN/197877_001/ccs 1/29/01 2:18 PM Page 87
Cleaning and Care• Your patient programmer is a precision device; handle it withcare. • Do not take apart or tamper with the programmer; this couldaffect how it works.• Protect the programmer from sharp blows or physical shocks.• Clean the outside of the programmer with a slightly dampcloth. Mild household cleaners will not damage the case orlabels. • Your patient programmer is not waterproof. Do not allowmoisture to get inside the device. • If you drop your patient programmer in water, refer to“Troubleshooting,” page 101. 7CautionDo not immerse the programmer in liquid. Do not clean it with bleach, nailpolish remover, or other similar substances.889900213EN/197877_001/ccs 1/29/01 2:18 PM Page 88
• Clean the battery contacts periodically with a cotton swabdampened with alcohol. Do not use a pencil eraser orsandpaper.• Replace low or depleted batteries to ensure proper operation.• When not using the programmer for more than 4 weeks,remove the battery to prevent possible corrosion of the patientprogrammer due to battery leakage.899900213EN/197877_001/ccs 1/29/01 2:18 PM Page 89
ServiceThe Itrel®EZ™Patient Programmer has been designed and testedto provide long, trouble-free service. If repair or service is needed,call Medtronic at 1-800-328-0810.To register the programmer for service covered by the warranty,complete and mail the warranty registration card. It is inserted inthis manual. The serial number is located on a label within thebattery compartment. It identifies each Itrel®EZ™PatientProgrammer. If you write or call Medtronic about your patientprogrammer, refer to the serial number.Battery and Device DisposalDispose of depleted programmer batteries and worn-out devicesaccording to local regulations.909900213EN/197877_001/ccs 1/29/01 2:18 PM Page 90
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TROUBLESHOOTINGThis section will help you solve problems or identify when to callyour doctor. Problems are described in the left column. The bluetext in the right column lists possible causes of the problem(Causes); the bold text in the right column describes how to correctthe problem (Action). Note: If your problem is not solved after several attempts,or if your problem is not described here, contact yourdoctor.Problem Causes and ActionYou’re too 1. Turn the neurostimulator off.uncomfortable 2. Reduce the amplitude, rate, and pulse width.with your current 3. Turn the neurostimulator on.stimulation to 4. Reset the rate and pulse width; reset amplitude last.think about howto change it.929900213EN/197877_001/ccs 1/29/01 2:18 PM Page 92
Problem Causes and ActionNo lights turn on after No battery or depleted battery. you try to program your Replace the battery; use a new 9-volt battery.neurostimulator.Sunlight may be making the programmer lights too dim.If you are outdoors, move indoors or into the shade.Your programmer does No battery or depleted battery. not respond to key Replace the battery; use a new 9-volt battery.presses.The Programmer Battery Programmer or detachable antenna is not alignedlight turns on, but none correctly over neurostimulator.of the neurostimulator Move the programmer or antenna and try again.lights are on.939900213EN/197877_001/ccs 1/29/01 2:18 PM Page 93
Problem Causes and ActionThe Neurostimulator The neurostimulator battery is low or depleted.Battery light is blinking, Contact your doctor.or it has been blinking and is now off.The programmer does Antenna not connected correctly. not work with the Disconnect the antenna, plug it in, and try again.detachable antenna connected. The antenna is not aligned over the neurostimulator.Refer to the instructions on page 69.The antenna is broken.Try programming without the detachable antenna. Replace detachable antenna with a new one.949900213EN/197877_001/ccs 1/29/01 2:18 PM Page 94
Problem Causes and ActionYou want to check If the neurostimulator is off, push the Off key. The your neurostimulator yellow Neurostimulator Off light should be lit.without changing the If the neurostimulator is on, push the On key. Thesetting. green Neurostimulator On light should be lit.Refer to “Checking the Neurostimulator Battery“on page 43 for more information.All the lights on your One of the programmer’s keys may have beenprogrammer are on, pressed during battery installation.and it does not respond Remove the battery for at least 3 seconds and then when you press a key. replace it, making sure no keys are pressed duringbattery installation.959900213EN/197877_001/ccs 1/29/01 2:18 PM Page 95
Problem Causes and ActionThe neurostimulator The programmer or detachable antenna is not aligned lights are off when correctly over the neurostimulator.you press any key. Move the programmer or antenna and try again.The programmer was removed from the neurostimulator too soon.Hold the programmer over the neurostimulator for at least 1 second after pressing a key.Radio signals from appliances, computers, machinery, etc. are affecting your programmer.Move to a different room and try again.Remove the detachable antenna and try again.The status lights The programmer failed the self-test and/or one of thedo not flash and the programmer’s keys was pressed during battery beeper does not installation.beep when a fresh Remove battery, press any key, turn the beeper to battery is installed. low or high, and insert a second fresh battery, making sure no keys are pressed during battery installation. The status lights should flash, and you should hear one beep. If this does not occur, contact your doctor.969900213EN/197877_001/ccs 1/29/01 2:18 PM Page 96
Problem Causes and ActionThe beeper does not The beeper is not on.sound. Only the Set the Beeper Volume Control switch to low or high Programmer Battery volume and listen to be sure it is working.light is on.The programmer or detachable antenna is not aligned correctly over the neurostimulator.Move the programmer or antenna and try again.The programmer was removed from the neurostimulator too soon.Hold the programmer over the neurostimulator for at least 1 second.Radio signals from appliances, computers, machinery, etc. are affecting your programmer.Move to a different room and try again.Remove the detachable antenna and try again.979900213EN/197877_001/ccs 1/29/01 2:18 PM Page 97
Problem Causes and ActionYou feel a programming The programmer was too far away from the neuro- change after pressing a stimulator. The neurostimulator might have received key, but the beeper the signal to change but did not tell the programmerdidn’t beep and what it did.the Neurostimulator Hold the programmer closer to your neurostimulatorOn or Off lights and try again.did not light.An electrical appliance blocked your neurostimulatorradio signal from telling the lights and beeper to turn on.1. Move to another room. Press any key to check the lights.2. Move the programmer and try again.The programmer was moved away too soon after pressing the keys.Hold the programmer over the neurostimulator for at least 1 second after pressing a key.989900213EN/197877_001/ccs 1/29/01 2:18 PM Page 98
Problem Causes and ActionYou do not feel Your doctor programmed a feature called stimulation right away SoftStart/Stop so that your stimulation will start after turning your and stop gradually.neurostimulator on, or Allow about 8 seconds for your neurostimulator to you feel stimulation turn on and off.after you turn the neurostimulator off.The programmer or detachable antenna is not aligned correctly over your neurostimulator.Move the programmer or antenna and try again.Your amplitude is set at its lowest setting.Slowly increase the amplitude until you feel stimulation.999900213EN/197877_001/ccs 1/29/01 2:18 PM Page 99
Problem Causes and ActionYour neurostimulator The programmer or detachable antenna is not will not turn on. aligned correctly over the neurostimulator.Move the programmer or antenna and try again.The programmer was removed from the neurostimulator too soon.Hold the programmer closer to your neurostimulator and try again. Hold the programmer over the neurostimulator for at least 1 second. The green Neurostimulator On light should be lit for 8 seconds after the key is pressed. Try again.Your amplitude is set at the lowest setting, and you don’t feel the stimulation.Slowly increase the amplitude until you feel stimulation.1009900213EN/197877_001/ccs 1/29/01 2:18 PM Page 100
Problem Causes and ActionYou spill fluid on your Dry it with a towel. programmer.Your programmer falls 1. Remove the programmer from water.into water. 2. Briefly rinse the patient programmer with cleantap water. Wipe it with a towel dampened with clean tap water.3. Remove the battery cover and battery. Shake the programmer to remove as much water as possible.4. Dry the battery compartment with a towel.5. Allow the battery compartment to dry at room temperature for as long as possible (24 hours recommended).6. Shake the programmer; if you see or hear water inside, repeat steps 4 and 5.7. When the programmer is dry, replace the battery and cover.8. If the programmer does not work properly, return it to Medtronic for service.Your programmer falls Try the programmer; it should work. If it does not off a cabinet or table. work, return it to Medtronic for service. 1019900213EN/197877_001/ccs 1/29/01 2:18 PM Page 101
LIVING WITH YOUR STIMULATION SYSTEMPatient Identification CardWhen you leave the hospital, your doctor will give you atemporary identification card. This card supplies basic informationabout your neurostimulator and identifies your doctor in the eventof an accident. Your identification card might allow you to bypasssecurity arches or wands such as those used in airports. After Medtronic receives your device registration information fromyour hospital, you will receive a permanent identification card.Carry this card with you at all times. If you move, change doctors,or lose your card, contact Medtronic Patient Services for a new card.Patient ServicesMedtronic Neurological710 Medtronic Parkway, NEMinneapolis, MN 55432-5604Toll-free: (800) 510-67351029900213EN/197877_001/ccs 1/29/01 2:18 PM Page 102
103In case of an emergency, please notify:PhysicianPhone ( )Medtronic Neurological, Minneapolis MN 55432-5604Telephone: (763) 514-5000 Toll-Free: (800) 510-6735Medical Device Temporary Identification The bearer of this card has an implanted medical device prescribed by his or her doctor.Patient’s NameAddressCity State or CountryPhone ( )Model NumberSerial NumberImplant DateUC200000981EN / 182403-0019900213EN/197877_001/ccs 1/29/01 2:18 PM Page 103
When to Call Your DoctorYour doctor will schedule follow-up visits. Your doctor will checkyour neurostimulator and make sure you are receiving the mostappropriate treatment. However, you should contact your doctor ifany of the following events occur:• You have pain, redness, or swelling at the incision site laterthan 6 weeks after surgery.• Your neurostimulator is not working properly.• You are not getting enough pain relief.• You feel discomfort or pain during stimulation. Turn theneurostimulator off first, then call your doctor.• You feel no stimulation, “tingling,“ when the neurostimulator is on.• You cannot turn the neurostimulator on or off.• You are unable to adjust stimulation with your patientprogrammer.1049900213EN/197877_001/ccs 1/29/01 2:18 PM Page 104
• Stimulation changes or stops and your pain returns.• The area of stimulation has changed dramatically (for example,moving from your right leg to your left leg).• The Neurostimulator Battery light on your patient programmeris blinking.• The Neurostimulator Battery light on your patient programmerwas blinking but is now off, regardless of which key you press.1059900213EN/197877_001/ccs 1/29/01 2:18 PM Page 105
Do’s and Don’tsBy following the guidelines listed below, you can ensure that yourpatient programmer will function properly.Do:• Keep your patient programmer out of the reach of children.• Use your patient programmer only as explained to you by yourdoctor or as discussed in this manual.• Handle your patient programmer with care. It is a sensitivedevice that can be damaged by rough handling.• Remove a worn-out battery from your patient programmer andreplace it with a new one. Worn-out batteries may damageelectronic circuits due to battery leakage.• Keep a fresh 9-volt battery available so that you can turn yourneurostimulator on and off or adjust the stimulation settingswhen needed.1069900213EN/197877_001/ccs 1/29/01 2:18 PM Page 106
• Turn your neurostimulator off when not in use. Theneurostimulator battery is not replaceable. When it wears out,the neurostimulator must be surgically replaced, so you willwant to make it last as long as possible. Battery life is dependenton the settings required to control your pain symptoms and onhow many hours per day you use your device.• Go to all follow-up appointments. Reschedule if an appointmentis missed.• Carry your patient identification card with you at all times.Don’t:7WarningDo not use potentially dangerous equipment (cars, power tools, etc.) whenyour neurostimulator is on. What may feel like a sudden increase instimulation (“jolt“ or “shock“) could cause you to lose control of theequipment you are using. Turn the neurostimulator off and set theamplitude to the lowest setting before using this type of equipment. • Don’t do any strenuous activity, such as heavy lifting, extremetwisting or bending, or running, without first talking to yourdoctor. 1079900213EN/197877_001/ccs 1/29/01 2:18 PM Page 107
Environmental ProblemsStrong electrical fields, such as those produced by radio towers orsome industrial equipment, can affect the function of yourneurostimulator. This can cause uncomfortable stimulation (a “jolt“ or “shock“). This problem is called electromagneticinterference, or EMI.7WarningElectrical interference or a strong magnetic field (electromagnetic or from apermanent magnet) could switch your neurostimulator on or off unlessyour doctor has disabled the circuit that allows on/off control with themagnet. If this happens, use your programmer to switch theneurostimulator back on or off. Electrical interference should not change thestimulation settings that are programmed into your neurostimulator.Most household appliances and office equipment do not produceinterference strong enough to affect your neurostimulator.1089900213EN/197877_001/ccs 1/29/01 2:18 PM Page 108
You can normally operate the following household items and office equipment:Note: Be sure that appliances and equipment are properlyinstalled and in good working condition before using them. Microwave ovensTelevisions, AM/FM radios,VCRs, etc.Tabletop appliances such astoasters, blenders, electriccan openers, and foodprocessorsHand-held items such ashair dryers, electric shavers,and remote controlsAppliances such as washers,dryers, garage door openers,electric stoves, and vacuumcleanersElectric blankets and heatingpadsPersonal computers, electrictypewriters, copiers, and faxmachines1099900213EN/197877_001/ccs 1/29/01 2:18 PM Page 109
Strong interference could cause your neurostimulator to deliverinappropriate or additional stimulation to your spinal cord.Turning the neurostimulator off may reduce the effect ofinterference.Devices or equipment to AVOID:Theft detectorsAirport/security screeningdevicesElectric arc weldingequipmentElectric substations andpower generatorsCB or ham radio antennasElectric induction heatersused in industry to bendplasticTV/radio transmittingtowersElectric steel furnaces1109900213EN/197877_001/ccs 1/29/01 2:18 PM Page 110
If you suspect that an electric or magnetic device is interferingwith your neurostimulator, move away from the device or, ifpossible, turn the device off. Then use the patient programmer toturn your neurostimulator on or off.7WarningUse care when approaching security arches or gates (such as those found inairports, libraries, and some department stores) as these devices can causeinappropriate or additional stimulation if you pass through them. Similarly,avoid airport security wands.When approaching security arches or gates, do the following:1. Show your patient identification card to security staff. Ask that you beallowed to bypass the security device, request a hand search, or ask thatthe security device be turned off.2. If passing through the security device is unavoidable, turn theneurostimulator off.3. Reduce the amplitude to the lowest setting.1119900213EN/197877_001/ccs 1/29/01 2:18 PM Page 111
1124. Approach the security device slowly. If any stimulation is felt, back outof the security device immediately without changing body position. Ifno stimulation is felt, move quickly through to the other side.Battery InformationYour neurostimulator operates on a sealed battery and, like allbatteries, it will not run indefinitely. To replace the battery, yourphysician must replace the entire neurostimulator. This requires asurgical procedure.See page 43 for information on how to check the status of yourneurostimulator battery.As the battery runs down, the stimulation may feel less intense,more intense, or different. These changes are normal and are nocause for alarm. When you feel this change in stimulation, makean appointment with your doctor to have your neurostimulatorbattery checked.9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 112
7CautionIf you have very low stimulation thresholds when your battery nears totaldepletion, you may feel more intense stimulation. Adjust yourneurostimulator amplitude to a desired level or turn it off.If the Neurostimulator Battery light on your patient programmerflashes, your neurostimulator may need replacement. Make anappointment with your doctor to have your neurostimulatorbattery checked.As the neurostimulator battery wears down, you may have toincrease the stimulation amplitude slightly to receive adequatepain relief.Battery and Device DisposalRemove the neurostimulator before burial or cremation. In somecountries removal of battery-operated implantable devices ismandatory because of environmental concerns; please check your1139900213EN/197877_001/ccs 1/29/01 2:18 PM Page 113
local regulations. Also, the cremation process causes the battery toexplode. Dispose of depleted batteries and worn-out devicesaccording to local regulations.Medical and Dental ProceduresWith proper precautions, most medical procedures are unlikely tointerfere with your neurostimulator. Always tell any medical staffthat you have an implanted stimulation system. Turn theneurostimulator off and decrease your amplitude to its lowestsetting before all medical and dental procedures.Some common medical and dental procedures that should notaffect your neurostimulator include:• Diagnostic x-rays such as dental x-rays—Exception: some x-rays that require tight enclosure of the area where yourneurostimulator is implanted (such as mammography) mayrequire adjustment to lessen pressure on your system.1149900213EN/197877_001/ccs 1/29/01 2:18 PM Page 114
• Dental drills and ultrasonic probes used to clean teeth—Exception: These should not be placed directly over yourimplant site.• Therapeutic ultrasound and electrolysis—Exception: Theseshould not be used directly over your implant site.7CautionSome medical procedures can damage the neurostimulation system or cancause changes to the system that may produce discomfort, pain, or injury.Consult your doctor about risks and benefits of procedures such as:• Electrosurgery (surgery performed by electrical methods)• Diathermy (heat treatment)• Lithotripsy (the crushing of a blockage within the urinary tractusing electrical methods)• Radiation therapy (that is, cancer treatment)• Magnetic resonance imaging (MRI)—not recommended• Defibrillation (electric shock to the heart)1159900213EN/197877_001/ccs 1/29/01 2:18 PM Page 115
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COMMONLY ASKED QUESTIONSWhat does stimulation feel like?The electrical pulses delivered by your neurostimulator usuallyfeel like tingling in the area of your pain.Can I turn my neurostimulator on or off?Yes. You can use your patient programmer or the controlmagnet to turn your neurostimulator on and off.Will I be able to adjust the stimulation?Yes. You can use your patient programmer to fine tune theamplitude, pulse width, and rate. However, this depends onthe instructions and limits your doctor has stored in yourneurostimulator. 1189900213EN/197877_001/ccs 1/29/01 2:18 PM Page 118
What should I do if I have trouble turning my neurostimulatoron?Be sure to wait at least 8 seconds to feel stimulation afterturning your neurostimulator on. If you do not feel anystimulation after 8 seconds, try again to turn the neuro-stimulator on while holding the patient programmer flatagainst your skin or clothing so that the keypad is directly overthe neurostimulator. If you still cannot turn your neuro-stimulator on, contact your doctor.How long will the battery in my neurostimulator last?The battery life of the neurostimulator depends on the numberof hours you use it each day and how strong the stimulationmust be to control your pain. Your doctor can give you anestimate after your neurostimulator settings have beendetermined.1199900213EN/197877_001/ccs 1/29/01 2:18 PM Page 119
Can the battery be recharged?No.How is the neurostimulator battery replaced?The entire neurostimulator must be surgically replaced becausethe neurostimulator’s battery is sealed within the device. Thisreplacement procedure usually does not include replacement ofthe lead or extension.How large is the neurostimulator?The neurostimulator is oval and approximately 2.4 inches long,2.2 inches wide, and 0.4 inches thick.Will the neurostimulator show through my clothes?Depending on your body build, the neurostimulator mayappear as a small bulge under the skin. However, your doctorwill try to place the neurostimulator in an area that is mostcomfortable and cosmetically acceptable.1209900213EN/197877_001/ccs 1/29/01 2:18 PM Page 120
Will my system limit my activities?Generally, no—you should be able to resume your normaldaily activities. However, be sure to consult your doctor beforeundertaking any particularly strenuous activities such as heavylifting or extreme twisting or bending.What happens if my neurostimulator stops working?Stimulation will stop and your pain may return. If thishappens, contact your doctor.Does the neurostimulator make any noise?No.What should I do if the stimulation changes or becomes painful?Use your patient programmer or the control magnet to turnyour neurostimulator off and contact your doctor.1219900213EN/197877_001/ccs 1/29/01 2:18 PM Page 121
What does it mean if I can feel stimulation only sometimes?Your doctor may have programmed your neurostimulator toturn on and off at regular intervals. However, if you do notreceive adequate pain relief, contact your doctor.Is it normal for the stimulation to increase or decrease when Ichange position?Generally, stimulation should feel constant. However, abruptmovements or changes in posture can make the stimulationfeel more or less intense due to the position of the electrode(s)relative to your spinal cord.Will a microwave oven interfere with the neurostimulator?No.How often should my doctor check the neurostimulator?Your neurostimulator should be checked once every 6 months.However, your doctor may want to see you more or less often,depending on your condition.1229900213EN/197877_001/ccs 1/29/01 2:18 PM Page 122
What happens at a follow-up visit?Your doctor will assess any changes in your medical condition,check your neurostimulator’s battery level, monitor any drugsyou are taking, and answer any questions you may have. Asyour condition changes, your physician may also reprogramyour neurostimulator.How often will I have to replace the battery in my patientprogrammer?Battery life depends on how often the programmer is used.Typically, a patient can expect at least 3 months of use from anew alkaline battery. Always keep a fresh battery available.1239900213EN/197877_001/ccs 1/29/01 2:18 PM Page 123
PATIENT PROGRAMMER SPECIFICATIONSPower Source: 9-volt alkaline battery (type 6LR61 or 6F22E)Operating Temperature: 49° F to 110° F9° C to 43° CStorage Temperature: -40° F to 149° F-40° C to 65° CRelative Humidity: 30% to 75%Atmospheric Pressure: 20.7 in. Hg to 31.3 in. Hg (700 hPa to 1060 hPa)Programmer Size: Approximately 2.4 x 5.3 x 1.2 inches (135 mm x 61 mm x 30 mm)Programmer Weight: Approximately 6 oz (170 g)(including battery)Battery Life: 3 months (average) for an alkaline batteryMode of Operation: Continuous1249900213EN/197877_001/ccs 1/29/01 2:18 PM Page 124
SPECIAL NOTICEMedtronic®Neurostimulator kits consist of a neurostimulator andtools to connect the neurostimulator to implantable extensions.Neurostimulators are used with extensions, which are implanted inthe extremely hostile environment of the human body. Neuro-stimulators may fail to function for a variety of causes including,but not limited to, medical complications, body rejection phenomena,or component failure. In addition, neurostimulators and tools maybe easily damaged by improper handling or use. For tools, Medtronicdisclaims all warranties, both express and implied, including, butnot limited to, any implied warranty of merchantability or fitnessfor a particular purpose. Medtronic shall not be liable to any personor entity for any medical expenses or any direct incidental or conse-quential damages caused by any defect, failure, or malfunction ofany tool, whether a claim for such damage is based upon warranty,contract, tort, or otherwise. No person has any authority to bind1259900213EN/197877_001/ccs 1/29/01 2:18 PM Page 125
Medtronic to any representation or warranty with respect to tools.1269900213EN/197877_001/ccs 1/29/01 2:18 PM Page 126
MEDTRONIC®NEUROLOGICALIMPLANTABLE NEUROSTIMULATORLIMITED WARRANTY(U.S. Customers Only)A. This Limited Warranty provides the following assurance to thepatient who receives a Medtronic® Itrel®3 Model 7425Neurostimulator, hereafter referred to as Neurostimulator:(1) Should the Neurostimulator fail to function within normaltolerances due to a defect in materials or workmanshipwithin a period of one (1) year, commencing with the date ofimplantation of the Neurostimulator, Medtronic will at itsoption: (a) issue a credit to the purchaser of the replacementNeurostimulator equal to the Purchase Price, as defined in `requested as its replacement, or (b) provide a functionallycomparable replacement Neurostimulator at no charge.1279900213EN/197877_001/ccs 1/29/01 2:18 PM Page 127
(2) Battery cell depletion will occur with time and is notconsidered to be a defect in materials or workmanship. Thebatteries have a specified capacity which may deplete atdifferent rates depending on Neurostimulator settings andrequirements for neurostimulation functions. Therefore, norepresentation is made that the Neurostimulator will last theentire term of this Limited Warranty.(3) As used herein, Purchase Price shall mean the lesser of thenet invoiced price of the original or current functionallycomparable, or replacement Neurostimulator.B. To qualify for the Limited Warranty, these conditions must bemet:(1) The Neurostimulator must be implanted prior to its “USEBY“ date in conjunction with Medtronic leads or leads ofequal quality and comparable electrical characteristics. (2) All device registration materials must be completed andreturned to Medtronic within thirty (30) days ofimplantation of the Neurostimulator.1289900213EN/197877_001/ccs 1/29/01 2:18 PM Page 128
(3) Replaced Neurostimulators must be returned to Medtronicwithin thirty (30) days of explantation and shall be theproperty of Medtronic.C. This Limited Warranty is limited to its express terms. Inparticular:(1) Except as expressly provided by this Limited Warranty,MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT,INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASEDON ANY DEFECT, FAILURE, OR MALFUNCTION OF THENEUROSTIMULATOR TO FUNCTION WITHIN NORMALTOLERANCES, WHETHER THE CLAIM IS BASED ONWARRANTY, CONTRACT, TORT, OR OTHERWISE.(2) This Limited Warranty is made only to the patient in whomthe Neurostimulator was originally implanted. AS TO ALLOTHERS, MEDTRONIC MAKES NO WARRANTY,EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITEDTO, ANY IMPLIED WARRANTY OF MERCHANTABILITYOR FITNESS FOR A PARTICULAR PURPOSE, WHETHERARISING FROM STATUTE, COMMON LAW, CUSTOM,1299900213EN/197877_001/ccs 1/29/01 2:18 PM Page 129
OR OTHERWISE. NO SUCH EXPRESS OR IMPLIEDWARRANTY TO THE PATIENT SHALL EXTEND BEYONDTHE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITEDWARRANTY SHALL BE THE EXCLUSIVE REMEDYAVAILABLE TO ANY PERSON.(3) The exclusions and limitations set out above are notintended to, and should not be construed so as tocontravene mandatory provisions of applicable law. If anypart or term of this Limited Warranty is held to be illegal,unenforceable, or in conflict with applicable law by a courtof competent jurisdiction, the validity of the remainingportions of the Limited Warranty shall not be affected, andall rights and obligations shall be construed and enforced asif this Limited Warranty did not contain the particular partor term held to be invalid. This Limited Warranty gives thepatient specific legal rights. The patient may also have otherrights which vary from state to state.1309900213EN/197877_001/ccs 1/29/01 2:18 PM Page 130
(4) No person has any authority to bind Medtronic to anyrepresentation, condition, or warranty except this LimitedWarranty.(5) This Limited Warranty is not applicable to leads, extensions,or accessories used with this Neurostimulator.* This Limited Warranty is provided by Medtronic Neurological, 800 53rd Avenue NE, Minneapolis, MN 55421-1200. Itapplies only in the United States. Areas outside the United States should contact their local Medtronic representativefor exact terms of the Limited Warranty.1319900213EN/197877_001/ccs 1/29/01 2:18 PM Page 131
MEDTRONIC®NEUROLOGICALITREL®EZ™MODEL 7434A PATIENT PROGRAMMERLIMITED WARRANTY(U.S. Customers Only)A. This Limited Warranty provides the following assurance to thepurchaser of the Medtronic®Itrel®EZ™Model 7434A PatientProgrammer, hereafter referred to as “Equipment“:(1) Should the Equipment fail to function within normaltolerances due to a defect in materials or workmanshipwithin a period of one (1) year, commencing with thedelivery of the Equipment to the purchaser, Medtronic willat its option: (a) repair or replace any part or parts of theEquipment; (b) issue a credit to the purchaser equal to thePurchase Price, as defined in Subsection A(2), against thepurchase of the replacement Equipment or (c) provide afunctionally comparable replacement Equipment at nocharge.1329900213EN/197877_001/ccs 1/29/01 2:18 PM Page 132
(2) As used herein, Purchase Price shall mean the lesser of thenet invoiced price of the original, or current functionallycomparable, or replacement Equipment.B. To qualify for Limited Warranty set forth in Section A(1), thefollowing conditions must be met:(1) The Equipment must be returned to Medtronic within thirty(30) days after discovery of the defect (Medtronic may, at itsoption, repair the Equipment on site).(2) The Equipment must not have been repaired or alteredoutside of Medtronic's factory in any way which, in thejudgment of Medtronic, affects its stability and reliability.The Equipment must not have been subjected to misuse,abuse, or accident.C. This Limited Warranty is limited to its express terms. Inparticular:(1) Except as expressly provided by this Limited Warranty,MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT,INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED1339900213EN/197877_001/ccs 1/29/01 2:18 PM Page 133
ON ANY DEFECT, FAILURE, OR MALFUNCTION OF THEEQUIPMENT, WHETHER THE CLAIM IS BASED ONWARRANTY, CONTRACT, TORT, OR OTHERWISE.(2) This Limited Warranty is made only to the purchaser of theEquipment. AS TO ALL OTHERS, MEDTRONIC MAKESNO WARRANTY, EXPRESS OR IMPLIED, INCLUDING,BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OFMERCHANTABILITY OR FITNESS FOR A PARTICULARPURPOSE WHETHER ARISING FROM STATUTE,COMMON LAW, CUSTOM, OR OTHERWISE. NOEXPRESS OR IMPLIED WARRANTY TO THE PATIENTSHALL EXTEND BEYOND THE PERIOD SPECIFIED INA(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THEEXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.1349900213EN/197877_001/ccs 1/29/01 2:18 PM Page 134
(3) The exclusions and limitations set out above are notintended to, and should not be construed so as tocontravene mandatory provisions of applicable law. If anypart or term of this Limited Warranty is held to be illegal,unenforceable, or in conflict with applicable law by a courtof competent jurisdiction, the validity of the remainingportions of the Limited Warranty shall not be affected, andall rights and obligations shall be construed and enforced asif this Limited Warranty did not contain the particular partor term held to be invalid. This Limited Warranty gives thepurchaser specific legal rights. The purchaser may also haveother rights which vary from state to state.(4) No person has any authority to bind Medtronic to anyrepresentation, condition, or warranty except this LimitedWarranty.* This Limited Warranty is provided by Medtronic Neurological, 800 53rd Avenue NE, Minneapolis, MN 55421-1200. Itapplies only in the United States. Areas outside the United States should contact their local Medtronic representativefor exact terms of the Limited Warranty.1359900213EN/197877_001/ccs 1/29/01 2:18 PM Page 135
GLOSSARYAmplitude—The amount or “volume”(strength or intensity) ofstimulation required to mask your pain. This setting is adjustedmost often by patients.Beeper Volume Control Switch—The switch located under thebattery cover. It lets you turn the beeper Off or set the volume toLow or High.Control Magnet—An optional magnet that allows you to turnyour neurostimulation system on and off. Electrode—The small metal conductor near the tip of the lead thatis placed near your spinal cord. Electrodes deliver tiny pulses ofelectricity to the area where your pain signals will be blocked.Electromagnetic Interference (EMI)—Interference caused by theenergy field generated by electrical or magnetic devices such as1369900213EN/197877_001/ccs 1/29/01 2:18 PM Page 136
airport security systems or television transmitting towers.Extension—The thin wire that connects the neurostimulator to thelead.Lead—The wire with small metal electrodes near the tip that isimplanted near the nerves to be stimulated.Neurostimulator—The power source of your system. It contains aspecial battery and electronics to control the stimulation you feel. Patient Programmer—The hand-held device that allows you toturn your neurostimulator on and off and finely adjust some of thestimulation settings programmed by your doctor.Physician Programmer—The small computer your doctor uses tosend stimulation instructions to your neurostimulator.Pulse Width—The length or duration of an electrical pulse.1379900213EN/197877_001/ccs 1/29/01 2:18 PM Page 137
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NO POSTAGENECESSARYIF MAILEDIN THEUNITED STATESBUSINESS REPLY MAILFIRST-CLASS MAIL PERMIT NO. 7611 MINNEAPOLIS, MNPOSTAGE WILL BE PAID BY ADDRESSEEMEDTRONIC NEUROLOGICALDEVICE REGISTRATION MS N700PO BOX 59262MINNEAPOLIS MN 55459-98959900213EN/197877_001/ccs 1/29/01 2:18 PM Page 139
IMPORTANT: Please detach, fill out, and mail this card to register your programmer.(The serial number is located under the 9-volt battery.)Itrel® EZ™ Patient Programmer Model 7434A Warranty Registration CardPurchase Date:(Mo)(Last) (First)(Area Code)(Day) (Yr)Name:(Last) (First)Name:Address:City:Zip Code:Zip Code:Implant Physician Name:Hospital Name:State:Address:City: State:Phone: () -Phone: () --Serial Number: NGL-9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 140
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Medtronic Neurological800 53rd Avenue NEMinneapolis, MN 55421-1200USAInternet: www.medtronic.comTel: (763) 514-5000Toll-free: (800) 328-0810FAX: (763) 514-5078UC199900213 EN PN197877-001 Rev. B© Medtronic, Inc. 2001All Rights Reserved9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 142

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