FCC ID: LF57434A Patient Programmer

9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 1 Itrel EZ Model 7434A Patient Programmer User Manual Rx Only 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 2 Explanation of Symbols on Products and Packaging Refer to the appropriate product to see symbols that apply. Keypad Symbols Neurostimulator On Neurostimulator Off Decrease Increase Status Light Symbols Stimulation Control Switch Symbols Beeper Volume Control Switch Symbols Amplitude Rate Pulse Width Volume Off Low Volume High Volume Miscellaneous Symbols Positioning Symbol Antenna Connector IEC 60601-1/EN60601-1, Type BF Equipment Conformit Europenne (European Conformity). This symbol means that the device fully complies with European Directive 90/385/EEC. For U.S. audiences only. Neurostimulator On Neurostimulator Off c

Neurostimulator Battery Programmer Battery 9V Risk Class 2 Equipment has been tested and accepted for listing under the Canadian Standard Association, for distribution in Canada. XXX hPa XX.X in. Hg hPa Storage Temperature XX %

XX %

Relative Humidity XX hPa XX.X in. Hg w Atmospheric Pressure Attention, see accompanying documents 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 3 Itrel EZ Patient Programmer Quick Programming Guide To turn the neurostimulator on or off:

1 Place the programmer over your neurostimulator. Location of Neurostimulator Green Neurostimulator On Light Medtronic Itrel EZ Model 7434A Yellow Neurostimulator Off Light 2 To turn the neurostimulator on:

a) Press the Neurostimulator On key. Listen for the confirmation beep. b) Check that the green Neurostimulator On light is lit. This light stays on for 8 seconds after you release the key. 3 To turn the neurostimulator off:

a) Press the Neurostimulator Off key. Listen for the confirmation beep. 9V Back of Patient Programmer b) Check that the yellow Neurostimulator Off light is lit. This light stays on for 8 seconds after you release the key. 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 4 To adjust amplitude, rate, or pulse width:

5 Remove the battery compartment cover.

) or

) key Press the Increase (

the Decrease (

to make a change. You should hear one beep for each change. 1 2 Select the stimulation setting:

amplitude (

rate (

pulse width (

), or

). 3 Place the programmer over your neurostimulator. 4 Press the neurostimulator On key. Listen for the confirmation beep. 1 6 R L 6

C E I V 9

+ l N S 6 Repeat steps 2-5 for other stimulation settings. Replace the battery cover. If the patient programmer beeps:

SOUND ACTION One beep You have pressed the On/Off or Increase/Decrease key and the change was received by the neurostimulator. Three rapid beeps Indicates one of the following:

You tried to adjust the lowest neurostimulator beyond theor highest settings. You tried to increase stimulation with the neurostimulator turned off. 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 5 A COMPANY DEDICATED TO PATIENTS Medtronic was founded in 1949 by Earl Bakken, a graduate student in electrical engineering, and his brother-in-law, Palmer J. Hermundslie. Today Medtronic is the world leader in medical technology, pioneering therapies that restore health, extend life, and alleviate pain. From its modest beginnings in a 600-square-foot Minneapolis garage, we have transformed Medtronic into a worldwide company that serves customers in more than 120 countries. Each year, millions of patients are treated with Medtronic products and therapies. We invest almost $500 million each year in research and development, working closely with the worlds leading physicians and scientists to enhance our current products and therapies, and to develop new ones. Although we are a large company, individual patients and their needs are still the driving force behind what we do and how we do it. Our goal is to improve the quality of your life. This booklet, which provides information about your 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 6 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page i CONTENTS ABOUT THIS BOOKLET .................................................................. 1 INTRODUCTION ............................................................................... 3 Indications..................................................................................................3 Contraindications .....................................................................................3 Warnings .................................................................................................... 4 Precautions ................................................................................................ 6 Risks of Surgery ........................................................................................9 Possible Side Effects.............................................................................. 10 Changes in Therapy............................................................................... 10 Possible Device Complications ........................................................... 11 RECOVERING FROM SURGERY................................................. 12 Healing..................................................................................................... 12 Physical Therapy and Medications..................................................... 12 Activities...................................................................................................13 WHAT IS PAIN? ................................................................................ 15 WHAT IS STIMULATION AND HOW DOES IT MANAGE PAIN?............................................................................. 15 i 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page ii WHAT DOES YOUR STIMULATION SYSTEM LOOK LIKE?..................................................................................... 17 HOW DOES YOUR STIMULATION SYSTEM WORK? ...........19 HOW DOES STIMULATION FEEL?............................................. 22 HOW IS YOUR ITREL 3 SYSTEM IMPLANTED?......................25 WHAT DOES THE PATIENT PROGRAMMER DO?................ 30 HOW DOES THE PATIENT PROGRAMMER WORK? ........... 31 PATIENT PROGRAMMER FEATURES ....................................... 32 Keypad...................................................................................................... 33 On/Off Keys ..................................................................................... 34 Increase and Decrease Keys ........................................................... 34 Control Switches .................................................................................... 35 Stimulation Control Switch ........................................................... 36 Beeper Volume Control Switch ..................................................... 37 Symbols and Status Lights................................................................... 38 Symbols.............................................................................................. 38 Status Lights...................................................................................... 38 ii 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page iii USING THE PATIENT PROGRAMMER ..................................... 41 Placing the Programmer over the Neurostimulator ....................... 41 Checking the Neurostimulator Battery ............................................. 43 Turning the Neurostimulator On and Off......................................... 45 Adjusting Your Stimulation .................................................................. 52 Programming Tips............................................................................ 53 Decreasing the Amplitude to the Lowest Setting........................ 56 Adjusting the Pulse Width.............................................................. 57 Adjusting the Rate............................................................................ 60 Adjusting the Amplitude ................................................................ 62 ACCESSORIES................................................................................... 65 Wrist Strap and Carrying Case ........................................................... 65 Detachable Antenna.............................................................................. 67 Attaching the Antenna over the Neurostimulator ...................... 69 Connecting the Antenna to the Patient Programmer ................. 71 Disconnecting the Antenna............................................................. 71 Caring for the Antenna.................................................................... 73 Caring for Your Skin ........................................................................ 74 Using your Control Magnet (Optional) ............................................ 75 iii 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page iv CARING FOR YOUR PATIENT PROGRAMMER..................... 79 Battery Cover .......................................................................................... 79 Removing the Battery Cover .......................................................... 79 Replacing the Battery Cover .......................................................... 80 Identification Label................................................................................ 81 Checking the Programmer Battery..................................................... 83 Removing the Battery............................................................................ 85 Installing the Battery ............................................................................. 86 Cleaning and Care ................................................................................. 88 Service ...................................................................................................... 90 Battery and Device Disposal................................................................ 90 TROUBLESHOOTING..................................................................... 92 LIVING WITH YOUR STIMULATION SYSTEM.................... 102 Patient Identification Card ................................................................. 102 When to Call Your Doctor................................................................... 104 Dos and Donts .................................................................................... 106 Environmental Problems.................................................................... 108 Battery Information................................................................................112 Battery and Device Disposal .............................................................. 113 Medical and Dental Procedures........................................................ 114 iv 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page v COMMONLY ASKED QUESTIONS........................................... 117 SPECIFICATIONS........................................................................... 123 SPECIAL NOTICE........................................................................... 124 LIMITED WARRANTY .................................................................. 125 GLOSSARY....................................................................................... 134 WARRANTY REGISTRATION CARD....................................... 139 QUICK PROGRAMMING GUIDE ............................................. 141 7 General Warning The Medtronic Itrel EZ Model 7434A Patient Programmer (the Programmer) is designed to program the adjustable parameters of the Medtronic Itrel 3 Implantable Neurostimulator (the neurostimulator). Do not attempt to use the programmer on another device (for example, a cardiac pacemaker). Radio signals from the patient programmer may interfere with the performance of other implantable devices. v 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page vi FCC INFORMATION The following is communications regulation information on the Itrel EZ Model 7434A Patient Programmer. FCC ID: LF57434A This device complies with Part 15 Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 1 ABOUT THIS BOOKLET For over 30 years, stimulation has helped thousands of patients manage their pain. This has also improved their quality of life. Your stimulation system may be used with other pain treatments like physical therapy or medicine. Stimulation will not cure your pain. It may, however, reduce your pain to a tolerable level. As a result, you may be able to resume your daily activities. 1 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 2 This booklet provides you with the following:

Indications, contraindications, warnings, precautions, risks of surgery, possible side effects, changes in therapy, and possible device complications What to expect as you recover from surgery Definition of pain and stimulation Description of your implanted system and how it works to manage your pain Description of your patient programmer, and how to use it and care for it Steps to take to help you solve problems or identify when you should call your doctor How to live with your stimulation system Answers to common questions Important terms that appear as bold in text; these terms are listed in the Glossary at the end of this booklet. Ask your doctor to explain anything that is unclear. 2 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 3 INTRODUCTION Indications The Medtronic Itrel 3 System is indicated as an aid in the management of chronic, intractable pain of the trunk or limbs. Patients should be carefully selected to assure that their pain is of physiologic origin. Also, patients must be appropriate candidates for surgery. 7 Caution All other uses remain investigational. Contraindications Implantation of an Itrel 3 System is contraindicated for:

Patients for whom trial stimulation is unsuccessful. Patients who are unable to properly operate the system. 3 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 4 Warnings Case DamageIf the neurostimulator case is pierced, severe burns could result. Equipment OperationDo not use potentially dangerous equipment (cars, power tools, etc.) when your neurostimulator is on. What may feel like a sudden increase in stimulation (jolt or shock) could cause you to lose control of the equipment you are using. Turn the neurostimulator off and set the amplitude to the lowest setting. Postural ChangesAs your spine moves, you may sense an increase or decrease in the stimulation. It may seem as though the neurostimulator is turning on or off. When you bend over or move suddenly, you may even feel an uncomfortable jolt or shock. PregnancySafety for use during pregnancy or delivery has not been established. 4 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 5 Theft Detectors and Screening DevicesUse care when approaching theft detectors and security arches (such as those found in airports, libraries, and some department stores) as these devices can cause momentary, uncomfortable, or painful stimulation. Similarly, avoid airport security wands. When approaching these devices do the following:

1. Show your patient identification card to security staff. Ask that you be allowed to bypass the security device, request a hand search, or ask that the security device be turned off. If passing through the security device is unavoidable, turn the neurostimulator off. 2. 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 changing body position. If no stimulation is felt, move quickly through to the other side. 5 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 6 Precautions Patient ManagementTo ensure the most benefit from your system, regular appointments with your doctor are recommended. Medical ProceduresSome medical procedures can damage the neurostimulation system or can cause changes to the system which may produce discomfort, pain, or injury. Consult your doctor about 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 tract using electrical methods) Radiation therapy (that is, cancer treatment) Magnetic resonance imaging (MRI)not recommended Defibrillation (electric shock to the heart) 6 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 7 Electromagnetic Interference (EMI)Strong electrical fields, such as those produced by radio towers or some industrial equipment, can affect the function of your neurostimulator. This can cause uncomfortable stimulation (a jolt or shock). This problem is called electromagnetic interference, or EMI. High/Low Pressure EffectsThe effects of high/low pressure

(that is, scuba diving, unpressurized airplanes) on patients with an implanted neurostimulation system are unknown. 7 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 8 Home AppliancesBe sure that appliances and equipment are properly installed and in good working condition before using them. Occupational EnvironmentsStrong interference could cause your neurostimulator to deliver inappropriate or additional stimulation to your spinal cord. Turning the neurostimulator off may reduce the effect of interference. Devices or equipment to avoid are theft detectors, airport/security screening devices, electric arc welding equipment, electric substations and power generators, CB or ham radio antennas, electric induction heaters used in industry to bend plastic, TV/radio transmitting towers, or electric steel furnaces. 8 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 9 Risks of Surgery Implanting the Itrel 3 System has the same risks as any other neurostimulation implant procedure. These risks include:

Spinal fluid leak, headache Fluid collection (seroma) or bruising (hematoma) at the neurostimulator site Bleeding near the spinal cord (epidural hemorrhage or hematoma) or paralysis Infection 9 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 10 Possible Side Effects Side effects of spinal cord stimulation are usually mild and go away when stimulation is turned off. Possible side effects include:

Chest wall stimulation Uncomfortable stimulation Jolting or shocking sensation Pain at the surgery sites Changes in Therapy There may be changes in the level of your pain control over time. In most cases, your doctor can correct these changes without surgery. However, it is possible that surgery may be required. 10 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 11 Possible Device Complications There may be pain, redness, or swelling at the neurostimulator site more than 6 weeks after surgery. The lead may move; surgery may be needed to reposition the lead. The system may wear through your skin; this can cause an infection or scarring. Pain control may decrease or stop due to device problems. One example 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 implanted materials. 11 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 12 RECOVERING FROM SURGERY Healing It takes several weeks to heal from surgery. You will feel some discomfort from the incision(s). You will also have some pain at the neurostimulator site for 2 to 6 weeks. This pain is normal. Physical Therapy and Medications Your physician may also prescribe physical therapy, medication, or both to help manage your pain. Always follow your doctors instructions for the therapy(ies) prescribed. 12 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 13 Activities During your recovery (about 6 weeks), follow your doctors advice. Avoid activities where you must bend, stretch, or twist your body; this can move your lead and alter your stimulation. To prevent lead movement, AVOID the following activities during your 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 pounds 13 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 14 As you begin to feel better, you should be able to return to activities 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 Traveling Discuss any type of strenuous activity with your doctor first, to avoid any possible damage to your system. Remember that returning to your daily activities should make you feel better, not worse. Note: As you adjust to life with better pain control, you may want to try activities that you could not perform before your surgery. Discuss this with your doctor first. 14 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 15 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 into feelings such as pressure, itching, tingling, or pain. It is your brain that feels pain, not the area of your body where the signal started. WHAT IS STIMULATION AND HOW DOES IT MANAGE PAIN?

Stimulation delivers tiny electrical pulses to the spinal cord. This blocks the pain signal as it travels to the brain. If the signal does not reach the brain, the pain is not felt. Note: Stimulation will not cure your pain nor will it block sharp pain caused by a recent injury. 15 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 16 Pain signal moving to brain is blocked by stimulation Pain signal is moving to brain from painful foot Stimulation blocks pain signals as they move to the brain. 16 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 17 WHAT DOES YOUR STIMULATION SYSTEM LOOK LIKE?

A typical stimulation system has three implanted parts: one neurostimulator, one lead, and one extension. Neurostimulator: The neurostimulator is the power source of your system. It contains a special battery and electronics to control the stimulation you feel. Note: In time, the battery inside your neurostimulator will wear out. When this occurs, your neurostimulator will need to be surgically replaced. Lead: The lead (pronounced leed) is a thin wire covered with a protective coating. The lead has small metal electrodes near the tip. The lead is surgically placed with the metal electrodes near your spinal cord. The electrodes transmit tiny electrical pulses to the area where your pain signals will be blocked. 17 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 18 Extension: The extension is a thin wire placed under the skin. It also is covered with a protective coating. The extension connects to the neurostimulator at one end and to the lead at the other end. Neurostimulator Extension Electrode Lead The parts of your stimulation system. 18 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 19 HOW DOES YOUR STIMULATION SYSTEM WORK?

After your surgery, your doctor used a physician programmer (a small computer) to send stimulation instructions to your neurostimulator. These instructions control the stimulation you feel. 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 your system. It allows you to turn your neurostimulator on and off. It also allows you to fine tune your stimulation. Your doctor or nurse will explain how to use the patient programmer. Refer to Using the Patient Programmer, on page 41. 19 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 20 An optional control magnet can also be used to turn your neurostimulator on and off. This magnet can also be used to start a dosage of stimulation if programmed by your doctor. You cannot use the control magnet to adjust amplitude. If necessary, your doctor can disable the circuit that allows on/off control with the magnet. A special code inside your neurostimulator allows only programming from the physician or patient programmer; other devices, such as the control magnet, are not able to program your neurostimulator. 20 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 21 Itrel EZ Patient Programmer Control Magnet Neurostimulator controlling devices. 21 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 22 HOW DOES STIMULATION FEEL?

Your neurostimulator sends tiny electrical pulses through the extension to the lead. The electrical pulses move through the lead and 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 slowly increases until it levels off. When your neurostimulator is turned off, the tingling slowly decreases until it stops. 22 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 23 Stimulation Area Painful Area Stimulation feels like tingling in the area of pain. 23 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 24 As your spine moves, you may sense an increase or decrease in the stimulation. It may seem as though the neurostimulator is turning on or off. When you bend over or move suddenly, you may even feel 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 move closer to or farther from the lead electrodes. For a moment, the stimulation may feel more or less intense than it should. Sudden changes in stimulation like these are most common during the recovery period. They usually decrease as you heal and the lead becomes more secure in your spinal column. 24 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 25 HOW IS YOUR ITREL 3 SYSTEM IMPLANTED?

Implantation of your Itrel 3 System has four basic steps and usually is done in one or two operations. The four steps are as follows:

Lead placement Screening Neurostimulator internalization Neurostimulator programming During the lead placement, you may be under a local anesthetic. The doctor will ask you to help determine when the lead is in the correct place. You will know the lead is correctly placed when you feel a tingling sensation in the area of your pain. This is the sensation you will feel instead of pain when your Itrel 3 System is blocking pain. 25 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 26 An external screener device provides the energy for the trial stimulation during the lead placement. If your doctor chooses to internalize the system in one operation., the neurostimulator is implanted after a successful lead placement. If the procedure is done in two operations, you will have a trial screening period of several days. Your doctor will use the screener to determine the most comfortable and effective stimulation settings for you. 26 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 27 The neurostimulator is internalized while you are under local or general anesthesia. This will occur after the screening period or, as previously explained, immediately after the lead placement. The doctor makes an incision in the skin, usually in the abdomen. Lead Neurostimulator Extension The neurostimulator is usually placed in the abdomen. 27 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 28 The neurostimulator is placed under the skin. The lead is then connected to the neurostimulator via the extension (wire). Your doctor will try to place the neurostimulator in an area that is most comfortable and cosmetically acceptable. After the internalization, your doctor will use the physician programmer to program the neurostimulator to the therapy settings that are appropriate to your needs. Your doctor may also choose to program a SoftStart/Stop stimulation. The SoftStart is a feature that gradually increases the amplitude from zero (0) to the programmed amplitude when your neurostimulator is turned on. When you turn off the neurostimulator, SoftStop gradually decreases the amplitude to zero (0) before turning off. 28 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 29 29 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 30 WHAT DOES THE PATIENT PROGRAMMER DO?

Use the patient programmer only with your implanted neurostimulator. DO NOT use the programmer on other devices

(such as a cardiac pacemaker). 7 Warning Signals (telemetry) from the patient programmer may disrupt the function of 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 instructions from the programmer. 30 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 31 HOW DOES THE PATIENT PROGRAMMER WORK?

The patient programmer sends signals to your neurostimulator. These signals tell the neurostimulator to turn on or off or to change 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. Location of Neurostimulator The programmer placed over the neurostimulator. 31 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 32 PATIENT PROGRAMMER FEATURES This section describes the features of the patient programmer. Keypad Battery Cover Release Tab 32 Battery Cover The patient programmer. 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 33 Keypad The keypad has 4 keys: Neurostimulator On and Increase and Decrease keys. Increase and Decrease Keys The keypad. and Off keys, Turns neurostimulator on Turns neurostimulator off 33 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 34 On and Off Keys Press the On and off. and Off keys to turn the neurostimulator on Increase and Decrease Keys A Stimulation Control switch, under the battery cover, is used to select the amplitude, rate, or pulse width. (See page 79 for information on removing the battery cover.) Press the Increase and/or Decrease key to adjust the amplitude, rate, or pulse width within ranges set by your doctor. 34 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 35 Control Switches The control switches and battery are located under the battery cover. For instructions on removing the battery cover, refer to page 79. Stimulation Control Switch

(Rate is selected) Beeper Volume Control Switch

(High volume is selected) Amplitude Rate Pulse Width Battery 1 6 R L 6

C E I V 9

+ l N S Off Low High Control switches and battery. 35 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 36 Stimulation Control Switch Depending on the instructions your doctor has programmed into your neurostimulator, you can adjust some or all of these settings with the Stimulation Control switch: amplitude, rate, and pulse width. Colors and symbols identify each setting (see below). Changing these settings will help you find the highest level of comfort and pain relief. Amplitude Rate Pulse Width 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 adjust the selected stimulation control. and Decrease keys on your keypad 36 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 37 Beeper Volume Control Switch The programmer beeps each time a change is received by your neurostimulator. Turn the beeper Off or set the volume to Low or High

(See Table 1.) If you hear One beep with the Beeper Volume Control switch. Table 1. Beeper description. It means You have pressed the On/Off or Increase/Decrease key and the change was successfully received by your 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 pulse width 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. 37 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 38 Symbols and Status Lights The back of your programmer displays symbols and status lights. These will help you during a programming session. Symbols A positioning symbol helps you align your programmer over the neurostimulator. An antenna symbol directs you to the detachable antenna connector. An optional, detachable antenna can be plugged in here. Status Lights When lit or blinking, the status lights tell you the following:

Whether the neurostimulator is on or off The neurostimulator battery status The programmer battery status 38 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 39 Detachable Antenna Symbol Green Neurostimulator On Light Green Neurostimulator Battery Light Green Programmer Battery Light Positioning Symbol Medtronic Itrel EZ Model 7434A Yellow Neurostimulator Off Light 9V Symbols and status lights on the back of the patient programmer. 39 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 40 40 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 41 USING THE PATIENT PROGRAMMER This section is organized as follows:

Placing the Programmer over the Neurostimulator Checking the Neurostimulator Battery Turning the Neurostimulator On and Off Adjusting Your Stimulation Placing the Programmer over the Neurostimulator Locate the neurostimulator implanted under your skin and hold the programmer over it. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. To send and receive signals, hold the programmer steady over the neurostimulator for at least 1 second while you press any key. When you align the programmer correctly over the neurostimulator, two or more lights will shine. 41 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 42 If the beeper is on, it will beep. The lights and beeper tell you that you have lined up the programmer and neurostimulator and they are sending signals to each other. If only the programmer battery light is lit and the beeper does not beep, move the programmer an inch or two and try again. Note: A detachable antenna is also available. This is helpful for patients who cannot reach their neurostimulator. Refer to Accessories on page 65 for more information. Position the programmer over the neurostimulator.

(Place against clothing or skin.) 42 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 43 Checking the Neurostimulator Battery The Neurostimulator Battery light on the back of the programmer tells you the status of your neurostimulator battery. See page 112 for information on what to do when your battery runs down. To check the neurostimulator battery:

1. Place the programmer over your neurostimulator. Hold the 2. programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. If your neurostimulator is off, press the Off key. If your neurostimulator is on, press the On key. Hold the programmer over the neurostimulator for at least 1 second. 3. Confirm that the green Neurostimulator Battery light on the back of the programmer is lit. Refer to Table 2 for more information about the Neurostimulator Battery light. 43 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 44 Note: Move indoors or into the shade if sunlight dims the programmer lights. Table 2. Neurostimulator Battery lights. When this happens Green Neurostimulator Battery light is on for 8 seconds after pressing any key. Green Neurostimulator Battery light is blinking for 8 seconds after pressing any key. Green Neurostimulator Battery light is off after pressing any key. It Means Neurostimulator battery is OK. The neurostimulator battery is low. Call your doctors office. Reposition programmer and try again. Interference from electrical equipment can cause lights to remain off. Move to another 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. 44 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 45 Turning the Neurostimulator On and Off Turn 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 need stimulation. You are using equipment that could be harmful to you or others 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 device such as those used in department stores and airports. 45 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 46 Notes:

Turning the neurostimulator off extends the battery life of your neurostimulator. When the battery wears out, the neurostimulator must be surgically replaced. You will want to make it last as long as possible. Decreasing the amplitude to the lowest setting will not turn off the neurostimulator. 7 Caution To avoid unpleasant stimulation, always decrease the amplitude to the lowest 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. 46 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 47 To turn the neurostimulator on:

1. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. Location of Neurostimulator Place the programmer over the neurostimulator. 2. Press the Neurostimulator On key and hold the programmer over the neurostimulator for 1 second. If the beeper is on, you should hear one beep to confirm that a change has occurred. 47 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 48 Press the Neurostimulator On key. 3. Check that the green Neurostimulator On light on the back of the programmer is lit; this indicates that the neurostimulator was 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 settings last programmed. 48 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 49 To turn the neurostimulator off:

1. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. Location of Neurostimulator Place the programmer over the neurostimulator. 2. Press the Neurostimulator Off key and hold the programmer over the neurostimulator for 1 second. If the beeper is on, you should hear one beep to confirm that a change has occurred. 49 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 50 Press the Neurostimulator Off key. 3. Check that the yellow Neurostimulator Off light on the back of the programmer is lit; this indicates that the neurostimulator was successfully turned off (see Table 3). This light stays on for 8 seconds after you release the key. Note: Move indoors or into the shade if sunlight dims the programmer lights. 50 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 51 4. Decrease the amplitude to the lowest setting (refer to pages 56 -

57 for instructions). 7 Caution To avoid unpleasant stimulation, always decrease the amplitude to the lowest setting after turning your neurostimulator off. Table 3. Neurostimulator On and Off lights. When The green Neurostimulator On light is lit for 8 seconds after pressing any key. It Means Neurostimulator is on. The yellow Neurostimulator Off light is lit Neurostimulator is off. for 8 seconds after pressing any key. Neither Neurostimulator On nor Off light is lit after pressing any key. The programmer does not know if the neurostimulator is on or off because it failed to communicate with the neurostimulator. Refer to Troubleshooting, page 96. 51 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 52 Adjusting Your Stimulation Table 4 provides some general guidelines for when you should adjust your stimulation. Your doctor will provide more complete guidelines. Table 4. When to adjust your stimulation. Adjust the Amplitude Before you adjust rate or pulse width After you turn the neurostimulator off When the tingling is not strong enough When the tingling is too strong Adjust the Pulse Width If the tingling does not cover your pain area If the tingling seems to cover too much area Adjust the Rate If the tapping is uncomfortable 52 Press This Key Press This Key Press This Key 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 53 Programming Tips The following tips are helpful when using the patient programmer. 7 Caution To avoid unpleasant stimulation, always decrease the amplitude to the lowest 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 that provide pain relief. The higher the settings, the faster your neurostimulator battery will wear out. When the battery wears 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 Stimulation Control switch. The Increase and Decrease adjust the stimulation setting that you select. keys will 53 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 54 The neurostimulator must be on to increase amplitude, rate, and pulse width. However, the neurostimulator may be either on or off to decrease the amplitude, rate, or pulse width. Use the lights on the back of the programmer to confirm that a change is taking place. The Neurostimulator On or Off lights, the Programmer Battery light, and the Neurostimulator Battery light should be lit after sending a change to the neurostimulator. This confirms that the neurostimulator is turned on or off, and that the neurostimulator and the programmer batteries are OK. These lights stay on for 8 seconds after you release the key. 54 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 55 If the beeper is on, the programmer will beep once for each change that is programmed into your neurostimulator. Your programmer will beep three times if you try to increase a stimulation setting when the neurostimulator is off. It will also beep three times if you have reached the lowest or highest value for the selected setting (amplitude, rate, or pulse width). The programmer will beep three times if you press On while the system is in dose lockout. You can increase or decrease settings more quickly by pressing and holding down the desired key. Every second, the programmer will send a change to the neurostimulator. 55 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 56 Decreasing the Amplitude to the Lowest Setting Always decrease the amplitude to the lowest setting before adjusting pulse width and rate or after turning your neurostimulator off. 1. Remove the battery cover. (Refer to Removing the Battery Cover, page 79.) 2. Move the Beeper Volume Control switch to Low 3. Move the Stimulation Control switch to amplitude or High

. Move the Stimulation Control switch to amplitude. 1 6 R 56 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 57 4. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. 5. Press and hold the Decrease key until the programmer beeps rapidly three times. This reduces the amplitude to the lowest setting. Note: The neurostimulator may be on or off when decreasing amplitude. 6. Replace the battery cover. (Refer to Replacing the Battery Cover, page 80.) Adjusting the Pulse Width 1. Remove the battery cover. (Refer to Removing the Battery Cover, page 79.) 2. Decrease the amplitude to the lowest setting as described on page 56. 57 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 58 7 Caution To avoid unpleasant stimulation, always decrease the amplitude to the lowest setting before adjusting the pulse width or rate of your neurostimulator. After rate or pulse width is set, slowly increase the amplitude to your comfort level. 3. Move the Stimulation Control switch to pulse width

. Move the Stimulation Control switch to pulse width. 1 6 58 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 59 4. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. to turn on the neurostimulator. 5. Press Neurostimulator On 6. Press the Increase 7. Move the Stimulation Control switch to amplitude 8. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. key to make a change. or Decrease

. 9. Press the Increase key to assess the change. Repeat steps 2 through 9 until the change is acceptable. 10. Replace the battery cover. (Refer to Replacing the Battery Cover, page 80.) 59 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 60 Adjusting the Rate 1. Remove the battery cover. (Refer to Removing the Battery Cover, page 79.) 2. Decrease the amplitude to the lowest setting as described on pages 56 - 57. 7 Caution To avoid unpleasant stimulation, always decrease the amplitude to the lowest setting before adjusting the pulse width or rate of your neurostimulator. After rate or pulse width is set, slowly increase the amplitude to your comfort level. 3. Move the Stimulation Control switch to rate

. 60 Move the Stimulation Control switch to rate. 1 6 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 61 4. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. 5. Press Neurostimulator On 6. Press the Increase 7. Move the Stimulation Control switch to amplitude 8. Place the programmer over your neurostimulator. Hold the key to make a change. to turn on the neurostimulator. or Decrease

. programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. 9. Press the Increase key to assess the change. Repeat steps 2 through 9 until the change is acceptable. 10. Replace the battery cover. (Refer to Replacing the Battery Cover, page 80.) 61 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 62 Adjusting the Amplitude 1. Remove the battery cover. (Refer to Removing the Battery Cover, page 79.) 2. Move the Stimulation Control switch to amplitude

. 1 6 R L Move the Stimulation Control switch to amplitude. 62 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 63 3. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. 4. Press Neurostimulator On 5. Press the Increase key to make a change. 6. Replace the battery cover. (Refer to Replacing the Battery to turn on the neurostimulator. or Decrease Cover, page 80.) 63 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 64 64 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 65 ACCESSORIES Wrist Strap and Carrying Case A wrist strap is packaged with the patient programmer and can be used to help you avoid dropping it. The wrist strap is attached near the battery cover release tab. A carrying case is also enclosed with the programmer. Store the patient programmer in the carrying case to protect it. 65 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 66 Wrist Strap Attachment Wrist Strap 66 Location of the wrist strap attachment. 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 67 Detachable Antenna A detachable antenna is available for patients who cannot reach their neurostimulator. The patient programmer can be used to program the neurostimulator as previously described. When connected, the detachable antenna turns off the programmers internal antenna. 7 Caution Do not attach the antenna over your neurostimulator incision using the adhesive discs until the incision heals. Note: When the detachable antenna is not used, keep the rubber plug in the antenna connector of the patient programmer. The rubber plug helps keep water out of the programmer. 67 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 68 To keep the antenna in place, use the adhesive discs supplied with the antenna. The adhesive discs are hypoallergenic. This helps reduce the chance of irritation. If irritation occurs, consult your doctor. Replace the adhesive discs every day. Before replacing an old disc with a fresh one, clean your skin using an antibacterial soap and dry thoroughly. 68 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 69 Attaching the Antenna over the Neurostimulator Adhesive Disc 1. Remove adhesive disc from square sheet. Adhesive Disc Antenna Coil 2. Attach disc to antenna coil. Remove protective covering. 69 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 70 Neurostimulator Antenna 3. Position antenna over neurostimulator as shown. 4. Press antenna firmly in place. Note: The antenna must be properly lined up over the neurostimulator for programming to occur. The programmers internal antenna is disabled when the antenna is properly connected. 70 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 71 Connecting the Antenna to the Patient Programmer 1. Pull out the rubber plug on the patient programmer to reveal the antenna connector. Note: The antenna connector is located on the end of the programmer near the keypad. Insert the antennas metal plug into the antenna connector and push the metal plug until it fits securely into place. Disconnecting the Antenna 1. Grasp the plug and pull it straight out. Do not pull on the cable because this may break the wires. Insert the rubber plug into the antenna connector. Note: Keep the rubber plug in the antenna connector when not in use; this helps keep water out of the programmer. 2. 2. 71 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 72 Keypad Antenna Connector Metal Plug Rubber Plug Antenna The detachable antenna and patient programmer. 72 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 73 Caring for the Antenna If you use the detachable antenna, you should wash it daily with mild soap and water. Note: Do not allow the metal plug end of the cord to get wet. 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 to protect it from dust. 73 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 74 Caring for Your Skin Skin may become irritated from the pressure of the antenna or from an allergic reaction to the adhesive used to hold the antenna in place. Therefore, it is very important to keep the skin in this area clean and dry. Inspect the area every day to see that the skin remains healthy. 7 Caution If 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 soap and 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 the antenna to the outside of the undergarment. 74 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 75 Using Your Control Magnet (Optional) By briefly applying and then removing the optional control magnet over your neurostimulator, you can turn it on or off. This feature 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 neurostimulator can vary from the examples shown in the following instructions. Have your doctor show you how to locate or position the magnet on your neurostimulator so that it is centered as shown in the following figure. Neurostimulator Control Magnet Magnet properly centered over neurostimulator. 75 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 76 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 the length of the neurostimulator. 76 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 77 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 a different position. Try a 1 oclock or 4 oclock position. 1 oclock position 4 oclock position 77 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 78 If your doctor has programmed the neurostimulator with the SoftStart/Stop feature, the magnet will automatically start the increase or decrease. If the neurostimulator has been programmed with a dosage of stimulation, the magnet will start the dose. Note: Allow a few seconds for the SoftStart circuit to raise the amplitude to the point where you can feel it. If your doctor has programmed the neurostimulator with the cycling feature and you use your magnet (or patient programmer) to turn off the neurostimulator, your therapy will then stop. When you reapply the magnet to turn on the neurostimulator again, your therapy always starts at the beginning of the On cycle. 78 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 79 CARING FOR YOUR PATIENT PROGRAMMER Battery Cover When the battery cover is removed, you can replace the battery or access the Stimulation Control switch. Removing the Battery Cover 1. Hold the programmer with one hand. 2. Lift the battery cover release tab on the end of the programmer. Lift off the cover. Release Tab Remove the battery cover. 79 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 80 Replacing the Battery Cover 1. Place the center hook on the edge of the cover into the center slot 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. 80 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 81 Identification Label Your patient programmer comes with an identification label. 1. Fill in the label (name, phone number, etc.) with permanent ink. 2. Peel off the backing and stick the label to the inside of the battery cover. Note: Do not place the label over the ridges on the battery cover. 81 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 82 Place Label Here Identification Label Inside Battery Cover Release Tab Placement of the identification label in the battery cover. 82 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 83 9V Checking the Programmer Battery A 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 device due 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. The programmer is designed to indicate its battery status with an alkaline battery installed; other battery types may not give accurate indications of the programmers battery status. The Programmer Battery light is located on the back of the programmer. It tells you the status of your programmer battery. 83 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 84 To check the programmer battery: Press any key on the patient programmer keypad. The green Programmer Battery light will respond. Refer to Table 5 for more information about the Programmer Battery light. Table 5. Programmer Battery 9V light. When Green Programmer Battery light is on for 8 seconds after pressing any key. It Means Programmer battery is OK. Green Programmer Battery light is blinking after pressing any key. Programmer battery is low. Replace with new 9-volt battery. Green Programmer Battery light is off after pressing any key. Replace with new 9-volt battery. 84 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 85 Removing the Battery 1. Remove the battery cover. (Refer to Removing the Battery Cover, page 79.) 2. Place one finger on the edge of the battery between the Control switches. 3. Lift the battery out of the compartment without using excessive force.

S N Remove the battery. 85 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 86 Installing the Battery An 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 the battery compartment. 3. Press the battery down fully into the battery compartment without using excessive force. Notes:

Do not press any of the programmers keys during battery insertion. The programmer performs a self-test when the battery is inserted. A successful check is indicated by a single flash of the status lights followed by a short beep. If this does not occur, the self-test has failed. Refer to Troubleshooting, page 96. 86 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 87 4. Replace the battery cover. (Refer to Replacing the Battery Cover, page 80.) 2.

S N 3. Install the battery. 87 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 88 Cleaning and Care Your patient programmer is a precision device; handle it with care. Do not take apart or tamper with the programmer; this could affect how it works. Protect the programmer from sharp blows or physical shocks. Clean the outside of the programmer with a slightly damp cloth. Mild household cleaners will not damage the case or labels. Your patient programmer is not waterproof. Do not allow moisture to get inside the device. If you drop your patient programmer in water, refer to Troubleshooting, page 101. 7 Caution Do not immerse the programmer in liquid. Do not clean it with bleach, nail polish remover, or other similar substances. 88 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 89 Clean the battery contacts periodically with a cotton swab dampened with alcohol. Do not use a pencil eraser or sandpaper. 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 patient programmer due to battery leakage. 89 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 90 Service The Itrel EZ Patient Programmer has been designed and tested to 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 in this manual. The serial number is located on a label within the battery compartment. It identifies each Itrel EZ Patient Programmer. If you write or call Medtronic about your patient programmer, refer to the serial number. Battery and Device Disposal Dispose of depleted programmer batteries and worn-out devices according to local regulations. 90 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 91 91 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 92 TROUBLESHOOTING This section will help you solve problems or identify when to call your doctor. Problems are described in the left column. The blue text in the right column lists possible causes of the problem

(Causes); the bold text in the right column describes how to correct the problem (Action). Note: If your problem is not solved after several attempts, or if your problem is not described here, contact your doctor. Causes and Action 1. Turn the neurostimulator off. 2. Reduce the amplitude, rate, and pulse width. 3. Turn the neurostimulator on. 4. Reset the rate and pulse width; reset amplitude last. Problem Youre too uncomfortable with your current stimulation to think about how to change it. 92 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 93 Causes and Action Problem No 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 presses. Replace the battery; use a new 9-volt battery. The Programmer Battery Programmer or detachable antenna is not aligned light turns on, but none of the neurostimulator Move the programmer or antenna and try again. lights are on. correctly over neurostimulator. 93 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 94 Problem Causes and Action The Neurostimulator Battery light is blinking, Contact your doctor. or it has been blinking and is now off. The neurostimulator battery is low or depleted. The programmer does not work with the detachable antenna connected. Antenna not connected correctly. Disconnect the antenna, plug it in, and try again. 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. 94 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 95 Problem You want to check your neurostimulator without changing the setting. Causes and Action If the neurostimulator is off, push the Off key. The yellow Neurostimulator Off light should be lit. If the neurostimulator is on, push the On key. The 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 programmers keys may have been programmer are on, 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 during battery installation. pressed during battery installation. 95 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 96 Causes and Action Problem The neurostimulator The programmer or detachable antenna is not aligned lights are off when you press any key. 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 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 programmer failed the self-test and/or one of the programmers keys was pressed during battery installation. Remove battery, press any key, turn the beeper to 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. The status lights do not flash and the beeper does not beep when a fresh battery is installed. 96 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 97 Problem The beeper does not sound. Only the Programmer Battery light is on. Causes and Action The beeper is not on. Set the Beeper Volume Control switch to low or high volume and listen to be sure it is working. 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. 97 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 98 Causes and Action Problem You 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 programmer didnt beep and what it did. the Neurostimulator Hold the programmer closer to your neurostimulator On or Off lights did not light. and try again. An electrical appliance blocked your neurostimulator radio 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. 98 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 99 Causes and Action Your doctor programmed a feature called Problem You do not feel stimulation right away SoftStart/Stop so that your stimulation will start after turning your neurostimulator on, or Allow about 8 seconds for your neurostimulator to you feel stimulation after you turn the neurostimulator off. and stop gradually. turn on and 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. 99 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 100 Causes and Action Problem Your 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 dont feel the stimulation. Slowly increase the amplitude until you feel stimulation. 100 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 101 Problem You spill fluid on your Dry it with a towel. programmer. Causes and Action Your programmer falls 1. Remove the programmer from water. into water. 2. Briefly rinse the patient programmer with clean tap 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. 101 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 102 LIVING WITH YOUR STIMULATION SYSTEM Patient Identification Card When you leave the hospital, your doctor will give you a temporary identification card. This card supplies basic information about your neurostimulator and identifies your doctor in the event of an accident. Your identification card might allow you to bypass security arches or wands such as those used in airports. After Medtronic receives your device registration information from your 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 Services Medtronic Neurological 710 Medtronic Parkway, NE Minneapolis, MN 55432-5604 Toll-free: (800) 510-6735 102 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 103 Medical Device Temporary Identification Physician In case of an emergency, please notify:

The bearer of this card has an implanted medical device prescribed by his or her doctor. Patients Name Address City State or Country Phone ( ) Phone ( ) Model Number Serial Number Implant Date Medtronic Neurological, Minneapolis MN 55432-5604 Telephone: (763) 514-5000 Toll-Free: (800) 510-6735 UC200000981EN / 182403-001 103 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 104 When to Call Your Doctor Your doctor will schedule follow-up visits. Your doctor will check your neurostimulator and make sure you are receiving the most appropriate treatment. However, you should contact your doctor if any of the following events occur:

You have pain, redness, or swelling at the incision site later than 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 the neurostimulator 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 patient programmer. 104 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 105 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 programmer is blinking. The Neurostimulator Battery light on your patient programmer was blinking but is now off, regardless of which key you press. 105 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 106 Dos and Donts By following the guidelines listed below, you can ensure that your patient 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 your doctor or as discussed in this manual. Handle your patient programmer with care. It is a sensitive device that can be damaged by rough handling. Remove a worn-out battery from your patient programmer and replace it with a new one. Worn-out batteries may damage electronic circuits due to battery leakage. Keep a fresh 9-volt battery available so that you can turn your neurostimulator on and off or adjust the stimulation settings when needed. 106 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 107 Turn your neurostimulator off when not in use. The neurostimulator battery is not replaceable. When it wears out, the neurostimulator must be surgically replaced, so you will want to make it last as long as possible. Battery life is dependent on the settings required to control your pain symptoms and on how many hours per day you use your device. Go to all follow-up appointments. Reschedule if an appointment is missed. Carry your patient identification card with you at all times. Dont:

7 Warning Do not use potentially dangerous equipment (cars, power tools, etc.) when your neurostimulator is on. What may feel like a sudden increase in stimulation (jolt or shock) could cause you to lose control of the equipment you are using. Turn the neurostimulator off and set the amplitude to the lowest setting before using this type of equipment. Dont do any strenuous activity, such as heavy lifting, extreme twisting or bending, or running, without first talking to your doctor. 107 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 108 Environmental Problems Strong electrical fields, such as those produced by radio towers or some industrial equipment, can affect the function of your neurostimulator. This can cause uncomfortable stimulation

(a jolt or shock). This problem is called electromagnetic interference, or EMI. 7 Warning Electrical interference or a strong magnetic field (electromagnetic or from a permanent magnet) could switch your neurostimulator on or off unless your doctor has disabled the circuit that allows on/off control with the magnet. If this happens, use your programmer to switch the neurostimulator back on or off. Electrical interference should not change the stimulation settings that are programmed into your neurostimulator. Most household appliances and office equipment do not produce interference strong enough to affect your neurostimulator. 108 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 109 You can normally operate the following household items and office equipment:

Microwave ovens Televisions, AM/FM radios, VCRs, etc. Tabletop appliances such as toasters, blenders, electric can openers, and food processors Hand-held items such as hair dryers, electric shavers, and remote controls Appliances such as washers, dryers, garage door openers, electric stoves, and vacuum cleaners Electric blankets and heating pads Personal computers, electric typewriters, copiers, and fax machines Note: Be sure that appliances and equipment are properly installed and in good working condition before using them. 109 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 110 Strong interference could cause your neurostimulator to deliver inappropriate or additional stimulation to your spinal cord. Turning the neurostimulator off may reduce the effect of interference. Devices or equipment to AVOID:

Theft detectors Airport/security screening devices Electric arc welding equipment Electric substations and power generators CB or ham radio antennas Electric induction heaters used in industry to bend plastic TV/radio transmitting towers Electric steel furnaces 110 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 111 If you suspect that an electric or magnetic device is interfering with your neurostimulator, move away from the device or, if possible, turn the device off. Then use the patient programmer to turn your neurostimulator on or off. 7 Warning Use care when approaching security arches or gates (such as those found in airports, libraries, and some department stores) as these devices can cause inappropriate or additional stimulation if you pass through them. Similarly, avoid airport security wands. When approaching security arches or gates, do the following:

1. 2. Show your patient identification card to security staff. Ask that you be allowed to bypass the security device, request a hand search, or ask that the security device be turned off. If passing through the security device is unavoidable, turn the neurostimulator off. 3. Reduce the amplitude to the lowest setting. 111 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 112 4. Approach the security device slowly. If any stimulation is felt, back out of the security device immediately without changing body position. If no stimulation is felt, move quickly through to the other side. Battery Information Your neurostimulator operates on a sealed battery and, like all batteries, it will not run indefinitely. To replace the battery, your physician must replace the entire neurostimulator. This requires a surgical procedure. See page 43 for information on how to check the status of your neurostimulator battery. As the battery runs down, the stimulation may feel less intense, more intense, or different. These changes are normal and are no cause for alarm. When you feel this change in stimulation, make an appointment with your doctor to have your neurostimulator battery checked. 112 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 113 7 Caution If you have very low stimulation thresholds when your battery nears total depletion, you may feel more intense stimulation. Adjust your neurostimulator amplitude to a desired level or turn it off. If the Neurostimulator Battery light on your patient programmer flashes, your neurostimulator may need replacement. Make an appointment with your doctor to have your neurostimulator battery checked. As the neurostimulator battery wears down, you may have to increase the stimulation amplitude slightly to receive adequate pain relief. Battery and Device Disposal Remove the neurostimulator before burial or cremation. In some countries removal of battery-operated implantable devices is mandatory because of environmental concerns; please check your 113 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 114 local regulations. Also, the cremation process causes the battery to explode. Dispose of depleted batteries and worn-out devices according to local regulations. Medical and Dental Procedures With proper precautions, most medical procedures are unlikely to interfere with your neurostimulator. Always tell any medical staff that you have an implanted stimulation system. Turn the neurostimulator off and decrease your amplitude to its lowest setting before all medical and dental procedures. Some common medical and dental procedures that should not affect your neurostimulator include:

Diagnostic x-rays such as dental x-raysException: some x-rays that require tight enclosure of the area where your neurostimulator is implanted (such as mammography) may require adjustment to lessen pressure on your system. 114 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 115 Dental drills and ultrasonic probes used to clean teeth Exception: These should not be placed directly over your implant site. Therapeutic ultrasound and electrolysisException: These should not be used directly over your implant site. 7 Caution Some medical procedures can damage the neurostimulation system or can cause 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 tract using electrical methods) Radiation therapy (that is, cancer treatment) Magnetic resonance imaging (MRI)not recommended Defibrillation (electric shock to the heart) 115 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 116 116 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 117 117 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 118 COMMONLY ASKED QUESTIONS What does stimulation feel like?

The electrical pulses delivered by your neurostimulator usually feel 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 control magnet 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 the amplitude, pulse width, and rate. However, this depends on the instructions and limits your doctor has stored in your neurostimulator. 118 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 119 What should I do if I have trouble turning my neurostimulator on?

Be sure to wait at least 8 seconds to feel stimulation after turning your neurostimulator on. If you do not feel any stimulation after 8 seconds, try again to turn the neuro-

stimulator on while holding the patient programmer flat against your skin or clothing so that the keypad is directly over the 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 number of hours you use it each day and how strong the stimulation must be to control your pain. Your doctor can give you an estimate after your neurostimulator settings have been determined. 119 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 120 Can the battery be recharged?

No. How is the neurostimulator battery replaced?

The entire neurostimulator must be surgically replaced because the neurostimulators battery is sealed within the device. This replacement procedure usually does not include replacement of the 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 may appear as a small bulge under the skin. However, your doctor will try to place the neurostimulator in an area that is most comfortable and cosmetically acceptable. 120 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 121 Will my system limit my activities?

Generally, noyou should be able to resume your normal daily activities. However, be sure to consult your doctor before undertaking any particularly strenuous activities such as heavy lifting or extreme twisting or bending. What happens if my neurostimulator stops working?

Stimulation will stop and your pain may return. If this happens, 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 turn your neurostimulator off and contact your doctor. 121 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 122 What does it mean if I can feel stimulation only sometimes?

Your doctor may have programmed your neurostimulator to turn on and off at regular intervals. However, if you do not receive adequate pain relief, contact your doctor. Is it normal for the stimulation to increase or decrease when I change position?

Generally, stimulation should feel constant. However, abrupt movements or changes in posture can make the stimulation feel 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. 122 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 123 What happens at a follow-up visit?

Your doctor will assess any changes in your medical condition, check your neurostimulators battery level, monitor any drugs you are taking, and answer any questions you may have. As your condition changes, your physician may also reprogram your neurostimulator. How often will I have to replace the battery in my patient programmer?

Battery life depends on how often the programmer is used. Typically, a patient can expect at least 3 months of use from a new alkaline battery. Always keep a fresh battery available. 123 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 124 PATIENT PROGRAMMER SPECIFICATIONS Power Source:

9-volt alkaline battery

(type 6LR61 or 6F22E) Operating Temperature:

Storage Temperature:

Relative Humidity:

Atmospheric Pressure:

Programmer Size:

Programmer Weight:

(including battery) Battery Life:

Mode of Operation:

49 F to 110 F 9 C to 43 C

-40 F to 149 F

-40 C to 65 C 30% to 75%

20.7 in. Hg to 31.3 in. Hg (700 hPa to 1060 hPa) Approximately 2.4 x 5.3 x 1.2 inches

(135 mm x 61 mm x 30 mm) Approximately 6 oz (170 g) 3 months (average) for an alkaline battery Continuous 124 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 125 SPECIAL NOTICE Medtronic Neurostimulator kits consist of a neurostimulator and tools to connect the neurostimulator to implantable extensions. Neurostimulators are used with extensions, which are implanted in the 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 may be easily damaged by improper handling or use. For tools, Medtronic disclaims all warranties, both express and implied, including, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. Medtronic shall not be liable to any person or entity for any medical expenses or any direct incidental or conse-

quential damages caused by any defect, failure, or malfunction of any tool, whether a claim for such damage is based upon warranty, contract, tort, or otherwise. No person has any authority to bind 125 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 126 Medtronic to any representation or warranty with respect to tools. 126 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 127 MEDTRONIC NEUROLOGICAL IMPLANTABLE NEUROSTIMULATOR LIMITED WARRANTY

(U.S. Customers Only) A. This Limited Warranty provides the following assurance to the patient who receives a Medtronic Itrel 3 Model 7425 Neurostimulator, hereafter referred to as Neurostimulator:

(1) Should the Neurostimulator fail to function within normal tolerances due to a defect in materials or workmanship within a period of one (1) year, commencing with the date of implantation of the Neurostimulator, Medtronic will at its option: (a) issue a credit to the purchaser of the replacement Neurostimulator equal to the Purchase Price, as defined in `

requested as its replacement, or (b) provide a functionally comparable replacement Neurostimulator at no charge. 127 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 128

(2) Battery cell depletion will occur with time and is not considered to be a defect in materials or workmanship. The batteries have a specified capacity which may deplete at different rates depending on Neurostimulator settings and requirements for neurostimulation functions. Therefore, no representation is made that the Neurostimulator will last the entire term of this Limited Warranty.

(3) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original or current functionally comparable, or replacement Neurostimulator. B. To qualify for the Limited Warranty, these conditions must be met:

(1) The Neurostimulator must be implanted prior to its USE BY date in conjunction with Medtronic leads or leads of equal quality and comparable electrical characteristics.

(2) All device registration materials must be completed and returned to Medtronic within thirty (30) days of implantation of the Neurostimulator. 128 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 129

(3) Replaced Neurostimulators must be returned to Medtronic within thirty (30) days of explantation and shall be the property of Medtronic. C. This Limited Warranty is limited to its express terms. In particular:

(1) Except as expressly provided by this Limited Warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE, OR MALFUNCTION OF THE NEUROSTIMULATOR TO FUNCTION WITHIN NORMAL TOLERANCES, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.

(2) This Limited Warranty is made only to the patient in whom the Neurostimulator was originally implanted. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM, 129 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 130 OR OTHERWISE. NO SUCH EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.

(3) The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Limited Warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the patient specific legal rights. The patient may also have other rights which vary from state to state. 130 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 131

(4) No person has any authority to bind Medtronic to any representation, condition, or warranty except this Limited Warranty.

(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. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for exact terms of the Limited Warranty. 131 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 132 MEDTRONIC NEUROLOGICAL ITREL EZ MODEL 7434A PATIENT PROGRAMMER LIMITED WARRANTY

(U.S. Customers Only) A. This Limited Warranty provides the following assurance to the purchaser of the Medtronic Itrel EZ Model 7434A Patient Programmer, hereafter referred to as Equipment:

(1) Should the Equipment fail to function within normal tolerances due to a defect in materials or workmanship within a period of one (1) year, commencing with the delivery of the Equipment to the purchaser, Medtronic will at its option: (a) repair or replace any part or parts of the Equipment; (b) issue a credit to the purchaser equal to the Purchase Price, as defined in Subsection A(2), against the purchase of the replacement Equipment or (c) provide a functionally comparable replacement Equipment at no charge. 132 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 133

(2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original, or current functionally comparable, or replacement Equipment. B. To qualify for Limited Warranty set forth in Section A(1), the following conditions must be met:

(1) The Equipment must be returned to Medtronic within thirty

(30) days after discovery of the defect (Medtronic may, at its option, repair the Equipment on site).

(2) The Equipment must not have been repaired or altered outside of Medtronic's factory in any way which, in the judgment 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. In particular:

(1) Except as expressly provided by this Limited Warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED 133 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 134 ON ANY DEFECT, FAILURE, OR MALFUNCTION OF THE EQUIPMENT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.

(2) This Limited Warranty is made only to the purchaser of the Equipment. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM, OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON. 134 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 135

(3) The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Limited Warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the purchaser specific legal rights. The purchaser may also have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation, condition, or warranty except this Limited Warranty.

* This Limited Warranty is provided by Medtronic Neurological, 800 53rd Avenue NE, Minneapolis, MN 55421-1200. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for exact terms of the Limited Warranty. 135 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 136 GLOSSARY AmplitudeThe amount or volume (strength or intensity) of stimulation required to mask your pain. This setting is adjusted most often by patients. Beeper Volume Control SwitchThe switch located under the battery cover. It lets you turn the beeper Off or set the volume to Low or High. Control MagnetAn optional magnet that allows you to turn your neurostimulation system on and off. ElectrodeThe small metal conductor near the tip of the lead that is placed near your spinal cord. Electrodes deliver tiny pulses of electricity to the area where your pain signals will be blocked. Electromagnetic Interference (EMI)Interference caused by the energy field generated by electrical or magnetic devices such as 136 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 137 airport security systems or television transmitting towers. ExtensionThe thin wire that connects the neurostimulator to the lead. LeadThe wire with small metal electrodes near the tip that is implanted near the nerves to be stimulated. NeurostimulatorThe power source of your system. It contains a special battery and electronics to control the stimulation you feel. Patient ProgrammerThe hand-held device that allows you to turn your neurostimulator on and off and finely adjust some of the stimulation settings programmed by your doctor. Physician ProgrammerThe small computer your doctor uses to send stimulation instructions to your neurostimulator. Pulse WidthThe length or duration of an electrical pulse. 137 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 138 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 139 NO POSTAGE NECESSARY IF MAILED IN THE UNITED STATES BUSINESS REPLY MAIL FIRST-CLASS MAIL PERMIT NO. 7611 MINNEAPOLIS, MN POSTAGE WILL BE PAID BY ADDRESSEE MEDTRONIC NEUROLOGICAL DEVICE REGISTRATION MS N700 PO BOX 59262 MINNEAPOLIS MN 55459-9895 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 140 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 Card Serial Number: N G L Purchase Date:

(Mo)

(Day)

(Yr) Name:

Name:

Address:

(Last) City:

Zip Code:

Implant Physician Name:

Phone:

) Hospital Name:

Address:

City:

Zip Code:

(Last)

(First) State:

Phone:

State:

(Area Code)

(First) 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 141 9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 142 Medtronic Neurological 800 53rd Avenue NE Minneapolis, MN 55421-1200 USA Internet: www.medtronic.com Tel: (763) 514-5000 Toll-free: (800) 328-0810 FAX: (763) 514-5078 UC199900213 EN PN197877-001 Rev. B Medtronic, Inc. 2001 All Rights Reserved