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.
9900213EN/197877_001/ccs ® Itrel EZ ™ 1/29/01 2:18 PM Page 3 To turn the neurostimulator on or off: 1 Quick Programming Guide Patient Programmer Place the programmer over your neurostimulator. Location of 2 To turn the neurostimulator on: a) Press the Neurostimulator On key. Listen for the confirmation beep. Neurostimulator b) Check that the green Neurostimulator On 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 To adjust amplitude, rate, or pulse width: Remove the battery compartment cover. 2 Select the stimulation setting: amplitude ( ), rate ( ), or pulse width ( ). 3 4 Place the programmer over your neurostimulator. Press the neurostimulator On key. Listen for the confirmation beep. 9V IEC-6LR61 1 SN l + Page 4 5 Press the Increase ( ) or the Decrease ( ) key to make a change. You should hear one beep for each change.
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.
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9900213EN/197877_001/ccs 1/29/01 2:18 PM Page i CONTENTS ABOUT THIS BOOKLET .................................................................. 1 INTRODUCTION ............................................................................... 3 Indications..................................................................................................3 Contraindications .....................................................................................3 Warnings ...........................................
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? ...........
900213EN/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...............................
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................................................................................
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 .......................................................................................
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.
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.
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
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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 4 Warnings Case Damage—If the neurostimulator case is pierced, severe burns could result. Equipment Operation—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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 5 Theft Detectors and Screening Devices—Use 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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 6 Precautions Patient Management—To ensure the most benefit from your system, regular appointments with your doctor are recommended. Medical Procedures—Some medical procedures can damage the neurostimulation system or can cause changes to the system which may produce discomfort, pain, or injury.
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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 8 Home Appliances—Be sure that appliances and equipment are properly installed and in good working condition before using them. Occupational Environments—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.
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.
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.
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.
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 doctor’s instructions for the therapy(ies) prescribed.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 13 Activities During your recovery (about 6 weeks), follow your doctor’s advice. Avoid activities where you must bend, stretch, or twist your body; this can move your lead and alter your stimulation.
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.
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.
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.
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.
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. Extension Neurostimulator Electrode Lead The parts of your stimulation system.
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.
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.
9900213EN/197877_001/ccs 1/29/01 Itrel® EZ™ Patient Programmer 2:18 PM Page 21 Control Magnet Neurostimulator controlling devices.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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 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. and Off keys, Turns neurostimulator on Increase and Decrease Keys Turns neurostimulator off The keypad.
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.
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) Battery Pulse Width Off + l Rate Low High SN Amplitude 9V IEC-6LR61 Beeper Volume Control Switch (High volume is selected) Control switches and battery.
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.
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 with the Beeper Volume Control switch. (See Table 1.) Table 1. Beeper description. If you hear It means One beep You have pressed the On/Off or Increase/Decrease key and the change was successfully received by your neurostimulator.
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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 39 Detachable Antenna Symbol Positioning Symbol Green Neurostimulator “On“ Light Medtronic® Itrel® EZ™ Model 7434A Yellow Neurostimulator “Off“ Light Green Neurostimulator Battery Light Green Programmer Battery Light 9V Symbols and status lights on the back of the patient programmer.
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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.
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.
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 programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. 2.
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 44 lights. When this happens It Means Green Neurostimulator Battery light is on for 8 seconds after pressing any key. Neurostimulator battery is OK. Green Neurostimulator Battery light is blinking for 8 seconds after pressing any key. The neurostimulator battery is low. Call your doctor’s office.
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.
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.
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.
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.
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.
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.
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 It Means The green Neurostimulator On light is lit for 8 seconds after pressing any key. Neurostimulator is on.
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.
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.
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.
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.
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. R61 1. Remove the battery cover. (Refer to “Removing the Battery Cover,” page 79.) 2. Move the Beeper Volume Control switch to Low or High 3. Move the Stimulation Control switch to amplitude . Move the Stimulation Control switch to amplitude. 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.
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. 61 3. Move the Stimulation Control switch to pulse width Move the Stimulation Control switch to pulse width. 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. 5. Press Neurostimulator On to turn on the neurostimulator. 6. Press the Increase or Decrease key to make a change. 7. Move the Stimulation Control switch to amplitude . 8. Place the programmer over your neurostimulator.
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. 60 61 3.
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 to turn on the neurostimulator. 6. Press the Increase or Decrease key to make a change. 7. Move the Stimulation Control switch to amplitude . 8. Place the programmer over your neurostimulator.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 62 Adjusting the Amplitude LR61 1. Remove the battery cover. (Refer to “Removing the Battery Cover,” page 79.) 2. Move the Stimulation Control switch to amplitude . Move the Stimulation Control switch to amplitude.
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 to turn on the neurostimulator. 5. Press the Increase or Decrease key to make a change. 6. Replace the battery cover. (Refer to “Replacing the Battery Cover,” page 80.
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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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 66 Wrist Strap Attachment 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 programmer’s internal antenna. 7 Caution Do not attach the antenna over your neurostimulator incision using the adhesive discs until the incision heals.
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.
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.
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 programmer’s internal antenna is disabled when the antenna is properly connected.
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. 2. Insert the antenna’s 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.
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.
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. 2. 3. 4. Disconnect the antenna from the programmer before cleaning. Wash the antenna with mild soap and water. Rinse the antenna. Make sure no soap remains on it. Dry the antenna with a clean towel immediately after washing.
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.
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.
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.
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 o’clock“ or “4 o’clock“ position.
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.
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.
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.
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.
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.
9900213EN/197877_001/ccs 9V 1/29/01 2:18 PM Page 83 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.
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. 9V Table 5. Programmer Battery 84 light. When It Means Green Programmer Battery light is on for 8 seconds after pressing any key. Programmer battery is OK. Green Programmer Battery light is blinking after pressing any key.
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. + SN Remove the battery.
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.
00213EN/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. + 3. SN Install the battery.
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.
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.
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.
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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.
9900213EN/197877_001/ccs 1/29/01 Problem 2:18 PM Page 93 Causes and Action 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 not respond to key presses. No battery or depleted battery. Replace the battery; use a new 9-volt battery.
9900213EN/197877_001/ccs 1/29/01 Problem 2:18 PM Page 94 Causes and Action The Neurostimulator The neurostimulator battery is low or depleted. Battery light is blinking, Contact your doctor. or it has been blinking and is now off. The programmer does 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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 95 Problem Causes and Action You want to check your neurostimulator without changing the setting. 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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 96 Problem Causes and Action The neurostimulator lights are off when you press any key. 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 after pressing a key. Radio signals from appliances, computers, machinery, etc.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 97 Problem Causes and Action The beeper does not sound. Only the Programmer Battery light is on. 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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 98 Problem Causes and Action You feel a programming change after pressing a key, but the beeper didn’t beep and the Neurostimulator On or Off lights did not light. The programmer was too far away from the neurostimulator. The neurostimulator might have received the signal to change but did not tell the programmer what it did. Hold the programmer closer to your neurostimulator and try again.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 99 Problem Causes and Action You do not feel stimulation right away after turning your neurostimulator on, or you feel stimulation after you turn the neurostimulator off. Your doctor programmed a feature called SoftStart/Stop so that your stimulation will start and stop gradually. Allow about 8 seconds for your neurostimulator to turn on and off. The programmer or detachable antenna is not aligned correctly over your neurostimulator.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 100 Problem Causes and Action Your neurostimulator will not turn on. The programmer or detachable antenna is not aligned correctly over the neurostimulator. Move the programmer or antenna and try again. The programmer was removed from the neurostimulator too soon. Hold the programmer closer to your neurostimulator and try again. Hold the programmer over the neurostimulator for at least 1 second.
9900213EN/197877_001/ccs Problem 1/29/01 2:18 PM Page 101 Causes and Action You spill fluid on your Dry it with a towel. programmer. Your programmer falls 1. Remove the programmer from water. into water. 2. Briefly rinse the patient programmer with 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.
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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 103 In case of an emergency, please notify: Medical Device Temporary Identification Physician The bearer of this card has an implanted medical device prescribed by his or her doctor.
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.
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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 106 Do’s and Don’ts 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.
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.
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.
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.
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.
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.
9900213EN/197877_001/ccs 4. 1/29/01 2:18 PM Page 112 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.
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.
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.
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 electrolysis—Exception: 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.
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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.
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 neurostimulator 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 neurostimulator on, contact your doctor.
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 neurostimulator’s 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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 121 Will my system limit my activities? Generally, no—you 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.
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.
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 neurostimulator’s 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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 124 PATIENT PROGRAMMER SPECIFICATIONS 124 Power Source: 9-volt alkaline battery (type 6LR61 or 6F22E) Operating Temperature: 49° F to 110° F 9° C to 43° C Storage Temperature: -40° F to 149° F -40° C to 65° C Relative Humidity: 30% to 75% Atmospheric Pressure: 20.7 in. Hg to 31.3 in. Hg (700 hPa to 1060 hPa) Programmer Size: Approximately 2.4 x 5.3 x 1.
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. Neurostimulators may fail to function for a variety of causes including, but not limited to, medical complications, body rejection phenomena, or component failure.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 126 Medtronic to any representation or warranty with respect to tools.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 127 MEDTRONIC® NEUROLOGICAL IMPLANTABLE NEUROSTIMULATOR LIMITED WARRANTY (U.S. Customers Only) A.
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.
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.
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.
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.
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.
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).
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.
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.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 136 GLOSSARY Amplitude—The amount or “volume” (strength or intensity) of stimulation required to mask your pain. This setting is adjusted most often by patients. Beeper Volume Control Switch—The switch located under the battery cover. It lets you turn the beeper Off or set the volume to Low or High. Control Magnet—An optional magnet that allows you to turn your neurostimulation system on and off.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 137 airport security systems or television transmitting towers. Extension—The thin wire that connects the neurostimulator to the lead. Lead—The wire with small metal electrodes near the tip that is implanted near the nerves to be stimulated. Neurostimulator—The power source of your system. It contains a special battery and electronics to control the stimulation you feel.
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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.
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.
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9900213EN/197877_001/ccs 1/29/01 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 2:18 PM Page 142 UC199900213 EN PN197877-001 Rev. B © Medtronic, Inc.
