Медтроник руководство пользователя

Медтроник-логотип

Medtronic, Inc. находится в Миннеаполисе, штат Миннесота, США, и является частью отрасли производства медицинского оборудования и расходных материалов. В Medtronic Usa, Inc. работает 40,000 695.90 сотрудников во всех подразделениях, а объем продаж составляет 655 млн долларов США. (Показатель продаж смоделирован). В корпоративную семью Medtronic Usa, Inc. входит XNUMX компаний. Их официальный webсайт Медтроник.ру.

Каталог руководств пользователя и инструкций для продуктов Medtronic можно найти ниже. Продукция Medtronic запатентована и зарегистрирована под торговыми марками Medtronic, Inc.

Контактная информация:

Адрес: 710 Medtronic Pkwy Миннеаполис, Миннесота, 55432-5604 США 

Сотрудники (этот сайт): Фактический 2,500 год
Сотрудники (все сайты): 40,000 Представить

Доход: $ 695.90 миллионов Рельефная

Год начала: 1984
Зарегистрировано: 1984

Рейтинг ESG: 3.0
Средний показатель по отрасли ESG: 2.24 

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Medtronic Strata Valve Reference Manual

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Strata

Valve

®

ADJUSTMENT REFERENCE GUIDE

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Summary of Contents for Medtronic Strata Valve

  • Page 1
    Strata Valve ® ADJUSTMENT REFERENCE GUIDE…
  • Page 2
    Strata Valve Adjustment Tools ® Preoperative Procedures READING THE PERFORMANCE LEVEL 1. Position the Locator Tool above the valve while it is still in the sterile 2. Set the Indicator Tool (compass) into the Locator Tool packaging, so the blue arrows are pointing in the same direction as while aligning the red bands on the tools.

  • Page 3: Postoperative Procedures

    StrataVarius Adjustment System ® Postoperative Procedures READING THE PERFORMANCE LEVEL 1. Insert the Smart Card (face-up) corresponding to the valve 2. Press the POWER button and allow the system time to complete to be read. the self-test. 3. Holding the system 10 cm above the valve and with the red arrow 4.

  • Page 4
    ADJUSTING THE PERFORMANCE LEVEL 7. Position the system directly over the valve, with the red arrow 8. Lower the Adjustment Tool (magnet) straight into the cutout, pointing in the direction of fluid flow. with the blue arrow pointing to the current valve setting. The magnet icon and calibration prompt will appear on the screen.

  • Page 5: Frequently Asked Questions

    StrataVarius Adjustment System ® Frequently Asked Questions ® Q: Can the StrataVarius System be used to read and adjust a Strata-type valve before it is implanted? ® A: Yes, but we suggest using the Strata Hand Tools while the valve is in the sterile packaging.

  • Page 6: Ordering Information

    Strata NSC Smart Card (Replacement) 45809 StrataVarius Magnet (Replacement) Indicator Tool Locator Tool Adjustment Tool For more information, contact your Medtronic Neurosurgery sales representative or refer to www.MedtronicNeurosurgery.com. Medtronic Neurosurgery International Telephone Numbers Rx only. Refer to product instruction 125 Cremona Drive…

Источник

  • Contents

  • Table of Contents

  • Troubleshooting

  • Bookmarks

Quick Links

      • (Models 37022, 37701, 37702, 37711, 37712, 37713, 37714, 97702, 97712, 97713, 97714)

PATIENT PROGRAMMER

97740

Pain therapy user manual for neurostimulation

system models 37022, 37701, 37702, 37703,

37704, 37711, 37712, 37713, 37714, 97702,

97712, 97713, 97714

  Rx only

! USA

2013

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Summary of Contents for Medtronic 97740

  • Page 1
    PATIENT PROGRAMMER 97740 Pain therapy user manual for neurostimulation system models 37022, 37701, 37702, 37703, 37704, 37711, 37712, 37713, 37714, 97702, 97712, 97713, 97714   Rx only ! USA 2013…
  • Page 2
    , RestoreUltra ® ® ® SoftStart/Stop , SureScan , and TargetMyStim trademarks of Medtronic, Inc., registered in the U.S. and other countries. FCC Information ! USA The following is communications regulation information on the Model 97740 Patient Programmer. FCC ID: LF537741 This device complies with Part 15 Rules.

  • Page 3: Label Symbols

    90/385/EEC (NB 0123) and R&TTE Directive 1999/5/EC. Consult instructions for use Manufacturer Serial number Authorized Representative in the EC REP European Community XX °C Temperature limitation XXX °F -XX °C -XX °F Non-ionizing electromagnetic radiation IEC 60601-1/EN60601-1, Type BF Equipment Antenna jack 97740 2015-03-01  English …

  • Page 4
    Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http:// recycling.medtronic.com for instructions on proper disposal of this product. For USA audiences only English  97740 2015-03-01…

  • Page 5: Table Of Contents

    Purpose of the device 28 Purpose of the neurostimulation system (indications) 29 Description of your system 29 Therapies that may not be used with the neurostimulation system (contraindications) 34 Risks and benefits 34 Risks of surgery 35 Warnings 35 Precautions 43 97740 2015-03-01  English …

  • Page 6
    Patient programmer Therapy screen 58 Status row 59 Group row 61 Parameter row 63 Patient programmer keys 64 Using the Sync key 66 Using the Navigator key 68 Turning your neurostimulator on or off 70 How to maintain the neurostimulator batteries 72 English  97740 2015-03-01…
  • Page 7
    Stimulation features 96 Adjusting stimulation settings 99 Increasing or decreasing a parameter (amplitude, pulse width, or rate) 104 Changing back to clinician settings 108 (Models 37022, 37702, 37712, 37713, 37714, 97702, 97712, 97713, 97714) 108 Viewing and changing a group 111 97740 2015-03-01  English …
  • Page 8
    AdaptiveStim groups and positions 126 Turning AdaptiveStim on and off 129 Making adjustments to AdaptiveStim 132 6  MRI examinations 136   If you have an MRI appointment 136 Responsibilities of the patient in preparing for the MRI appointment 136 English  97740 2015-03-01…
  • Page 9
    At the MRI appointment 137 Placing your neurostimulation system in MRI mode for the MRI scan 139 Using the Model 97740 patient programmer to activate MRI mode 140 Activating MRI mode 141 Turning stimulation back on after the MRI scan 148…
  • Page 10
    What your clinician controls 195 What you control 195 Possible adverse effects 196 Changes in therapy 196 Possible system complications 196 10  User assistance 200   User assistance 200 Declaration of Conformity 201 11  Appendix A: Electromagnetic   interference (EMI) 204 Contraindication 204 English  97740 2015-03-01…

  • Page 11: English

    Warnings 205 Precautions 216 Notes 220 Index 224 97740 2015-03-01  English …

  • Page 12: Glossary

    Clinician — A healthcare professional such as a doctor or nurse. Clinician programmer — A device used by a clinician to send instructions to a neurostimulator. Contraindication — A condition or circumstance when a person should not have a neurostimulation system. English  97740 2015-03-01…

  • Page 13
    EOS (End of service) — The neurostimulator has reached the scheduled end of service and no longer delivers the electrical pulses that block pain signals. 97740 2015-03-01  English …
  • Page 14
    Indication — The purpose of the neurostimulation system and the medical condition for which it may be implanted. Neurostimulation system — The implanted and external components of the stimulation system that delivers electrical pulses to block pain signals as they move to the brain. English  97740 2015-03-01…
  • Page 15
    Eventually, the battery loses enough charge to permanently affect the neurostimulator. If this occurs, the battery is overdischarged. Parameter — One of three stimulation settings that adjust the electrical pulse: amplitude, pulse width, and rate. 97740 2015-03-01  English …
  • Page 16
    OFF. Spinal cord — This is your body’s information center. Nerve signals from the entire body travel to your spinal cord, and then to your brain. English  97740 2015-03-01…
  • Page 17
    Therapy — Treatment of a disease or condition. When neurostimulation therapy is prescribed, a neurostimulation system is used to deliver stimulation to one or more pain sites. 97740 2015-03-01  English …
  • Page 18
    Therapy settings — A specific combination of amplitude, rate, and pulse width parameters acting on a specific electrode set that determines the stimulation pulses that are delivered. Warning — A statement describing an action or situation that could harm the patient. English  97740 2015-03-01…

  • Page 19: Introduction

    1 Introduction…

  • Page 20: How To Use This Manual

    • Chapter 3 «Recovery and care after surgery» provides information about recovering from surgery, activity and care information, and when to contact your clinician. English  97740 2015-03-01…

  • Page 21
    • Chapter 8 «Troubleshooting» describes patient programmer warning and information screens and how to solve possible problems. • Chapter 9 «Additional information» describes how stimulation works, possible 97740 2015-03-01  English …

  • Page 22: Patient Guides

    Notes: • If your implantable neurostimulator (INS) has a rechargeable battery, you should receive documents for the neurostimulator charging system. • If you have an external neurostimulator you will receive the Medtronic Model English  97740 2015-03-01…

  • Page 23
      Table 1.1 Patient guides for an implanted neurostimulator Patient guide Rechargeable Non- rechargeable Medtronic Model 97740 Patient Programmer: Pain Therapy User Manual. See page 20 for details. Medtronic Model 97740 Patient Programmer: Quick Reference Guide. Provides instructions for common patient programmer tasks.
  • Page 24
      Table 1.1 Patient guides for an implanted neurostimulator (continued) Patient guide Rechargeable Non- rechargeable Medtronic Model 37751 Recharger: Charging System User Manual. Describes the charging system and how to use it with a rechargeable neurostimulator. Medtronic Model 37751 Recharger: Charging System Quick Reference Guide.

  • Page 25: Patient Identification Card

    MRI appointments (see Chapter 6 «MRI examinations»). If you move, change doctors, or lose your card, contact Medtronic for a replacement card. Refer to the Medtronic contacts at the end of this manual. A temporary identification card will be ! USA provided at the hospital.

  • Page 26
    English  97740 2015-03-01…

  • Page 27: Important Therapy Information

    2 Important therapy information…

  • Page 28: Purpose Of The Device

    Purpose of the device The Medtronic Model 97740 Patient Programmer is designed to program the following Medtronic neurostimulators: Rechargeable • Restore Model 37711 • RestoreUltra Model 37712 • RestoreUltra with SureScan MRI Technology Model 97712 • RestoreAdvanced Model 37713 •…

  • Page 29: Purpose Of The Neurostimulation System (Indications)

    Description of your system A typical neurostimulation system has implanted parts that deliver the electrical pulses to the area where your pain signals are blocked. Typically the implanted parts of a neurostimulation system include (Figure 2.1): 97740 2015-03-01  English …

  • Page 30
    2.1 Implanted parts of a typical neurostimulation system (spinal cord stimulation shown). A typical neurostimulation system also includes an external patient programmer for controlling your system. If you have a rechargeable neurostimulator, your system also includes a charging system (Figure 2.2). English  97740 2015-03-01…
  • Page 31
    2.2 External parts of a typical neurostimulation system. Neurostimulator – The neurostimulator is the power source (battery) for your neurostimulation system. It contains electronics that generate the electrical pulses. During test stimulation, an external neurostimulator is used to determine whether 97740 2015-03-01  English …
  • Page 32
    RestoreUltra with SureScan MRI Technology Model 97712 • RestoreAdvanced Model 37713 • RestoreAdvanced with SureScan MRI Technology Model 97713 • RestoreSensor Model 37714 • RestoreSensor with SureScan MRI Technology Model 97714 Non-rechargeable neurostimulators • RestorePrime Model 37701 • PrimeAdvanced Model 37702 English  97740 2015-03-01…
  • Page 33
    (refer to «Using the detachable antenna» on page 91). Charging system used with a rechargeable neurostimulator – The charging system is used to charge the 97740 2015-03-01  English …

  • Page 34: Therapies That May Not Be Used With The Neurostimulation System (Contraindications)

    Risks and benefits Stimulation has helped thousands of patients manage their pain and improve their quality of life. Your neurostimulation system may be used with other pain treatments. Stimulation English  97740 2015-03-01…

  • Page 35: Risks Of Surgery

    Electromagnetic interference (EMI) is a field of energy generated by equipment found in the home, work, medical, or public environments that is strong enough to interfere with neurostimulator function. Neurostimulators include features that provide protection from EMI. Most electrical 97740 2015-03-01  English …

  • Page 36
    (POR) values, resulting in loss of neurostimulation, return of underlying symptoms, and in the case of POR, requiring your health care provider to reprogram the neurostimulator. • Unexpected changes in stimulation, causing a momentary increase in English  97740 2015-03-01…
  • Page 37
    Refer to the following table for information on the effect of EMI on you and your neurostimulation system. Additional information and instructions on how to reduce the risk from EMI are located in Appendix A of this manual. 97740 2015-03-01  English …
  • Page 38
    English  97740 2015-03-01…
  • Page 39
    97740 2015-03-01  English …
  • Page 40
    English  97740 2015-03-01…
  • Page 41
    97740 2015-03-01  English …
  • Page 42
    Defibrillation therapy from an implanted defibrillator can damage the neurostimulator. • The electrical pulses from the neurostimulation system could affect the sensing operation from the cardiac device and result in inappropriate responses from the cardiac device. Your doctor should English  97740 2015-03-01…

  • Page 43: Precautions

    Programmer interaction with other active implanted devices—If you have a neurostimulator and another active implanted device: 97740 2015-03-01  English …

  • Page 44
    Component compatibility—For proper therapy, use only Medtronic Neuromodulation components that are prescribed by your physician. Patient control devices may affect other implanted devices—Do not place patient control devices (eg, patient programmer) over English  97740 2015-03-01…
  • Page 45
    The consequences of using a battery-powered device near flammable or explosive atmospheres are unknown. Communication interference from EMI— When using your patient programmer to communicate with your neurostimulator, move away from equipment that may 97740 2015-03-01  English …
  • Page 46
    Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching can cause parts of your neurostimulation system to fracture or migrate. This can result in loss English  97740 2015-03-01…
  • Page 47
    2.0 atmospheres absolute (ATA). Pressures below 10 meters (33 feet) of water (or above 2.0 ATA) can damage the neurostimulation system. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with your doctor. 97740 2015-03-01  English …
  • Page 48
    (eg, driving, operating power tools). Discuss these activities with your doctor. English  97740 2015-03-01…

  • Page 49: Individualization Of Treatment

    • you cannot properly operate the system, • you do not receive satisfactory results from test stimulation. Use in specific populations—The safety and effectiveness of this therapy has not been established for the following: 97740 2015-03-01  English …

  • Page 50
    • Pregnancy, unborn fetus, or delivery • Pediatric use (patients under the age of English  97740 2015-03-01…

  • Page 51: Recovery And Care After Surgery

    3 Recovery and care after surgery…

  • Page 52: Recovery From Surgery

    Sudden changes in stimulation are most common during recovery. • Avoid activities where you must bend, stretch, or twist your body; these movements can move your leads, which affects your stimulation. English  97740 2015-03-01…

  • Page 53
    • Traveling Remember, returning to your daily activities should make you feel better, not worse. Note: As you adjust to life with better pain management, you may want to try activities that you could not perform before your 97740 2015-03-01  English …

  • Page 54: When To Call Your Clinician

    Your system is not working properly. • You cannot turn the neurostimulator on or off. • You cannot adjust stimulation using your patient programmer. Care schedule Your clinician will schedule follow-up visits to make sure you are receiving the most appropriate therapy. English  97740 2015-03-01…

  • Page 55
    4 Using your patient programmer…

  • Page 56: Using Your Patient Programmer

    (Figure 4.1). Notes: • Keep your patient programmer accessible at all times. • The internal antenna is on the back of the patient programmer. • The patient programmer screen must face outward. English  97740 2015-03-01…

  • Page 57
    (refer to page 91). Patient programmer with internal antenna Neurostimulator Figure 4.1 Placing the patient programmer over the neurostimulator. Use the patient programmer to: • turn the neurostimulator on or off. • check the neurostimulator battery. • change stimulation settings. 97740 2015-03-01  English …

  • Page 58: Patient Programmer Therapy Screen

    Some figures may display battery level icons that are unique to rechargeable neurostimulators. Patient programmer Therapy screen The Therapy screen displays icons and numbers that indicate your neurostimulator and patient programmer status and your stimulation settings (Figure 4.2). English  97740 2015-03-01…

  • Page 59: Status Row

    Information on the Therapy screen is arranged in three rows: the Status row, the Group row, and the Parameter row. Status row The Status row is the top row of the Therapy screen (Figure 4.3). 97740 2015-03-01  English …

  • Page 60
    Refer to Table 4.1 for a description of the icons that may appear on the Status row.   Table 4.1 Status row icons Icon Description Neurostimulator is off (Implanted or external neurostimulator) Neurostimulator is on (Implanted or external neurostimulator) English  97740 2015-03-01…

  • Page 61: Group Row

    Group row The Group row is the middle row of the Therapy screen (Figure 4.4). The Group row will only appear on the Therapy screen if your neurostimulator supports the Group feature and your clinician has programmed the Group setting. 97740 2015-03-01  English …

  • Page 62
    Refer to Table 4.2 for a description of the icons that may appear on the Group row.   Table 4.2 Group row icons Icon Description Active Not active Group name (can be icons or text) Scheduled Therapy AdaptiveStim position (can be this icon or text) English  97740 2015-03-01…

  • Page 63: Parameter Row

    Refer to Table 4.3 for a description of the icons that may appear on the Parameter row.   Table 4.3 Parameter row icons Icon Description Amplitude 97740 2015-03-01  English …

  • Page 64: Patient Programmer Keys

      Table 4.3 Parameter row icons (continued) Icon Description Pulse width Rate GroupAdjust TargetMyStim AdaptiveStim position … Patient programmer keys Decrease Increase Neurostimulator on Power / Neurostimulator off Backlight Sync Navigator Figure 4.6 Patient programmer keys. English  97740 2015-03-01…

  • Page 65
    • The patient programmer must be held over the neurostimulator while pressing the Neurostimulator on key or Neurostimulator off key. • Pressing either of these keys also automatically synchronizes the neurostimulator and patient programmer and displays the Therapy screen. 97740 2015-03-01  English …

  • Page 66: Using The Sync Key

    Pressing and holding the key changes the parameter every half- second. • To increase a parameter, the neurostimulator must be turned on. Using the Sync key Use the Sync key to synchronize your neurostimulator and patient programmer (Figure 4.7). English  97740 2015-03-01…

  • Page 67
    All communication with the neurostimulator begins with synchronization. After synchronization, the Therapy screen appears. To synchronize your neurostimulator and the patient programmer, hold the patient programmer over your neurostimulator and press the Sync key. After synchronization, the Therapy screen appears. 97740 2015-03-01  English …

  • Page 68: Using The Navigator Key

    The selection box on the Therapy screen acts as a cursor to show which row is selected for programming. If there is more information on the row than can be displayed, the Options icon will appear next to the selection box (Figure 4.9). English  97740 2015-03-01…

  • Page 69
    When moving the selection box with the Navigator key, you do not need to hold the programmer over your neurostimulator. However, you must hold the patient programmer over your neurostimulator when pressing all other keys except the Power/Backlight key. 97740 2015-03-01  English …

  • Page 70: Turning Your Neurostimulator On Or Off

    1. Hold the patient programmer over your neurostimulator with the patient programmer screen facing outward and press the Neurostimulator on Neurostimulator off key (Figure 4.10). 2. Verify that the appropriate On or Off icon is displayed on the Therapy screen (Figure 4.10). English  97740 2015-03-01…

  • Page 71
    3. If you have turned the neurostimulator off, decrease the program amplitudes to the lowest setting. For instructions, see «Increasing or decreasing a parameter (amplitude, pulse width, or rate)» on page 104. 97740 2015-03-01  English …

  • Page 72: How To Maintain The Neurostimulator Batteries

    Checking the external neurostimulator battery Check the external neurostimulator battery level every day. Complete the following steps to check the external neurostimulator battery. 1. Synchronize the patient programmer and neurostimulator. English  97740 2015-03-01…

  • Page 73
    The Therapy screen appears. 2. Review the external neurostimulator battery level on the Therapy screen (Figure 4.11). Battery level Replace Full batteries Figure 4.11 External neurostimulator battery status. Table 4.5 lists the message screens associated with the external neurostimulator batteries. 97740 2015-03-01  English …

  • Page 74: Checking The Implanted Rechargeable Neurostimulator Battery

    Replace the external neurostimulator batteries. Refer to the manual packaged with the external neurostimulator. Press any arrow on the Navigator key to clear this information screen. Checking the implanted rechargeable neurostimulator battery (Models 37711, 37712, 37713, 37714, 97712, 97713, 97714) English  97740 2015-03-01…

  • Page 75
    (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function. Allowing the neurostimulator battery to overdischarge will permanently affect the 97740 2015-03-01  English …
  • Page 76
    The third time the battery is overdischarged, the neurostimulator will reach end of service. Surgery is required to replace the neurostimulator. Complete the following steps to check the implanted rechargeable neurostimulator battery. English  97740 2015-03-01…
  • Page 77
    Therapy screen (Figure 4.12). Battery charge level Charge Full neurostimulator Figure 4.12 Implanted neurostimulator charge level on the Therapy screen. Table 4.6 on page 78 lists the message screens associated with the implanted rechargeable neurostimulator battery charge level. 97740 2015-03-01  English …
  • Page 78
    The implanted rechargeable neurostimulator battery charge level is low and stimulation will not be available soon. Charge the neurostimulator battery. Refer to the manual packaged with the charging system. Press any arrow on the Navigator key to clear this information screen. English  97740 2015-03-01…

  • Page 79: Checking The Implanted Nonrechargeable Neurostimulator Battery

    Press the Sync key. The Therapy screen appears. 2. Review the battery status on the Therapy screen. Table 4.7 lists the message screens associated with the implanted nonrechargeable neurostimulator battery. 97740 2015-03-01  English …

  • Page 80
    Call your clinician to report this message screen. Press any arrow on the Navigator key to clear this information screen. This screen reappears daily. After clearing this screen, a low battery level icon appears on the Status row of the Therapy screen. English  97740 2015-03-01…

  • Page 81: Changing Patient Programmer Preferences

    Table 4.8 lists the icons associated with the preference settings and where to find information on other features.   Table 4.8 Preference settings icons Icons Preference Audio Contrast Time Time and number format Group name display 97740 2015-03-01  English …

  • Page 82
    Complete the following steps to change patient programmer preferences. 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. English  97740 2015-03-01…
  • Page 83
    Navigator key to move the selection box to the desired preference (Figure 4.14). Figure 4.14 Moving to the desired preference. 4. Press the down arrow to move the selection box to the Change row (Figure 4.15). 97740 2015-03-01  English …
  • Page 84
      Table 4.9 Changing patient programmer preferences Audio 1. Press the left or right arrow on the Navigator key to move the selection box to audio on or off . 2. Go to step 6, page 88. English  97740 2015-03-01…
  • Page 85
      Table 4.9 Changing patient programmer preferences (continued) Contrast 1. Press the left or right arrow on the Navigator key to make the contrast lighter darker . 2. Go to step 6, page 88. 97740 2015-03-01  English …
  • Page 86
    Navigator key to return to the Therapy screen. 5. Press the Sync key to send the change to your neurostimulator. 6. To verify the time change, repeat steps 2 and 3 on page 83 to return to the Time Preference screen. English  97740 2015-03-01…
  • Page 87
    1. Press the left or right arrow on the Navigator key to move the selection box to one of the following: – icons ( – letters ( ), or – text ( 2. Go to step 6, page 88. 97740 2015-03-01  English …
  • Page 88
    – English, – French, – German, – Italian, – Spanish, or – AdaptiveStim icon only. 2. Go to step 6, page 88. 6. When the change is displayed on the screen, move the selection box to the Status row. English  97740 2015-03-01…

  • Page 89: Using The Carrying Case And Labeling The Patient Programmer

    Using the carrying case and labeling the patient programmer The carrying case has a pouch to hold the patient programmer and the quick reference guide (Figure 4.16). The case also has a loop on the back that attaches to a belt. 97740 2015-03-01  English …

  • Page 90
    4.16 Insert the patient programmer into the case. Place an identification label on the back of your patient programmer in case the patient programmer is lost (Figure 4.17). ID label Figure 4.17 Place the adhesive label on the back of the patient programmer. English  97740 2015-03-01…

  • Page 91: Using The Detachable Antenna

    It is also useful for viewing the patient programmer screen while you are adjusting stimulation. Complete the following steps to use the detachable antenna. 1. Place the antenna over your neurostimulator (Figure 4.18). Figure 4.18 Place the antenna over your neurostimulator. 97740 2015-03-01  English …

  • Page 92
    (Figure 4.19). Figure 4.19 Pull the fabric through the slit (a) and wedge in place (b). 3. Push the antenna plug firmly into the antenna jack ( ) on the patient programmer (Figure 4.20). English  97740 2015-03-01…
  • Page 93
    4.20 Insert the antenna plug into the antenna jack. 4. After the antenna is connected, follow the instructions for using the patient programmer. 5. When you have finished using the patient programmer, grasp the antenna plug and pull it out. 97740 2015-03-01  English …
  • Page 94
     Caution: Do not pull directly on the antenna cable to disconnect the cable from the programmer because this may damage the antenna cable. English  97740 2015-03-01…
  • Page 95
    5 Adjusting your stimulation…

  • Page 96: Adjusting Your Stimulation

    For complete information, see «Increasing or decreasing a parameter (amplitude, pulse width, or rate)» on page 104. For information about other stimulation features and which neurostimulators support these features, refer to Table 5.1 on page 97. English  97740 2015-03-01…

  • Page 97
    97740 2015-03-01  English …
  • Page 98
    English  97740 2015-03-01…

  • Page 99: Adjusting Stimulation Settings

    Talk to your clinician about the settings that apply to your therapy. Your clinician programs the available functions and specifies the settings you can adjust with your patient programmer. Discuss this with your clinician. 97740 2015-03-01  English …

  • Page 100
    To receive the most effective therapy, some days you may need to adjust your stimulation several times; other days you may not need to adjust it at all. Your clinician will provide complete guidelines about when you may want to adjust your stimulation. English  97740 2015-03-01…
  • Page 101
    Table 5.2 provides general guidelines for adjusting your stimulation. For additional adjustment guidelines refer to the sections on the specific features associated with your neurostimulator. 97740 2015-03-01  English …
  • Page 102
    Stimulation does not cover Increase amplitude(s) or painful area pulse width(s) or change to a different group The pulses (tapping Increase rate sensations) feel too slow The pulses (tapping Decrease rate sensations) feel too fast English  97740 2015-03-01…
  • Page 103
    You will be passing through a theft detector or security device Before engaging in these activities, consult «Appendix You will be using A: Electromagnetic potentially dangerous interference (EMI)» for equipment details. You will be having a medical procedure 97740 2015-03-01  English …

  • Page 104: Increasing Or Decreasing A Parameter (Amplitude, Pulse Width, Or Rate)

    Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears.  Caution: To prevent possible uncomfortable or unexpected stimulation (jolting or shocking sensation) when stimulation is turned English  97740 2015-03-01…

  • Page 105
    5.1 Moving to the desired parameter. Notes: – Only one parameter for one program can be displayed at a time on the Parameter row. Scrolling to the right displays the amplitude ( ) for each program, followed by the pulse 97740 2015-03-01  English …
  • Page 106
    – Pressing and holding the Increase or Decrease key changes the value every half-second. – If one of the information screens in Table 5.3 appears, you tried to increase or decrease the parameter beyond the limits programmed by your English  97740 2015-03-01…
  • Page 107
    (lower limit). Press any arrow on the Navigator key to clear the information screen. You tried to increase a parameter above the highest value allowed (upper limit). Press any arrow on the Navigator key to clear the information screen. 97740 2015-03-01  English …

  • Page 108: Changing Back To Clinician Settings

    You can change the stimulation settings back to the original settings programmed by your clinician. Complete the following steps to change back to clinician settings. Note: Clinician settings will be applied to the group that is active. If your neurostimulator English  97740 2015-03-01…

  • Page 109
    Press the Sync key. The Therapy screen appears. 2. Press the up arrow on the Navigator key to move the selection box to the Status row (Figure 5.2). Status row Figure 5.2 Accessing preferences from the Status row. 97740 2015-03-01  English …
  • Page 110
    4. Press the down arrow to move the selection box to the Change row (Figure 5.3). Change row Figure 5.3 Change row for selected preference. 5. Press the Sync key to send the change to your neurostimulator and return to the Therapy screen. English  97740 2015-03-01…

  • Page 111: Viewing And Changing A Group

    Complete the following steps to change to a new group and make the new group active. 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. 97740 2015-03-01  English …

  • Page 112
    (Figure 5.5).  Caution: Select the group that your clinician has recommended for the current activity or posture. Use of another group may result in uncomfortable or unexpected stimulation (jolting or shocking sensation) when stimulation is turned English  97740 2015-03-01…
  • Page 113
    4. Hold the patient programmer over your neurostimulator and press the Sync key to send the change to your neurostimulator (Figure 5.6). 5. Verify that the new group is active on the Therapy screen (Figure 5.6). Figure 5.6 Making a group active. 97740 2015-03-01  English …

  • Page 114: Displaying Group Names

      Table 5.4 Group name (icons/text) Icon Text Definition Group for sitting Stand Group for standing Group for lying Walk Group for walking Sleep Group for sleeping Write Group for writing English  97740 2015-03-01…

  • Page 115
    Group for hand pain Foot Group for foot pain The text listed in this column will be displayed on the patient programmer exactly as shown in this column (ie, the text will not be translated from English into local languages). 97740 2015-03-01  English …

  • Page 116: Using Groupadjust

    GroupAdjust can be used to adjust all the program amplitudes for the active group at the same time. Parameter row Figure 5.7 GroupAdjust on the Parameter row. When the Increase key or Decrease key is selected, the GroupAdjust screen is displayed (Figure 5.8). Figure 5.8 GroupAdjust screen. English  97740 2015-03-01…

  • Page 117
    To increase the amplitude, the neurostimulator must be on. • To decrease the amplitude, the neurostimulator may be on or off. 1. Synchronize the patient programmer and neurostimulator. a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. 97740 2015-03-01  English …
  • Page 118
    5. Once the desired levels are displayed, release the Increase or Decrease key to save the amplitude adjustment and to return to the Therapy screen. Notes: – One program amplitude (represented by one of the bars) may reach its English  97740 2015-03-01…

  • Page 119: Viewing Scheduled Therapy

    If your clinician programmed Scheduled Therapy, the Scheduled Therapy icon ( ) appears in the Group row. Scheduled Therapy allows your clinician to program therapy for a specific time of day. You can view Scheduled Therapy status from the Therapy screen. 97740 2015-03-01  English …

  • Page 120
    • Stimulation is off during sleep Stimulation is stopped Group B is active Figure 5.9 Example of Scheduled Therapy. Note: You can still change groups or turn your neurostimulator on or off when Scheduled Therapy is programmed. English  97740 2015-03-01…

  • Page 121: Using Targetmystim

    AdaptiveStim, TargetMyStim is not available for AdaptiveStim groups (refer to page 124 for more information on AdaptiveStim). The small metal electrodes near the tip of the lead are not all active at the same time. Only 97740 2015-03-01  English …

  • Page 122
    3 out of a possible 5 positions. The number of available positions will vary depending on how your clinician programmed your neurostimulator. When the Increase key or Decrease key is selected, the TargetMyStim screen is displayed showing the current position and the selected position (Figure 5.11). English  97740 2015-03-01…
  • Page 123
    2. Verify that the group is active ( ) and the selection box is located on the TargetMyStim icon on the Parameter row (Figure 5.10 on page 121). 3. Hold the patient programmer over your neurostimulator and press the Increase 97740 2015-03-01  English …

  • Page 124: Using Adaptivestim

    6. Press the left arrow on the Navigator key to return to the Therapy screen. Using AdaptiveStim (Models 37714, 97714) If your clinician has programmed AdaptiveStim and AdaptiveStim is turned on, English  97740 2015-03-01…

  • Page 125
    The next time you return to this position, the stimulation will match what you selected the last time you were in this position. Note: There may be a short delay before the stimulation changes in response to your 97740 2015-03-01  English …

  • Page 126: Adaptivestim Groups And Positions

    AdaptiveStim recognizes these 6 positions: • Standing or sitting still • Lying on your back or face up • Lying on your front or face down • Lying on your right side • Lying on your left side • Mobile English  97740 2015-03-01…

  • Page 127
    Therapy screen may not be your current position or the settings currently in use by your neurostimulator. You must synchronize the patient programmer and neurostimulator (refer to «Using the Sync key» on page 66) to display 97740 2015-03-01  English …
  • Page 128
    Use the definitions listed in Table 5.5 to understand the AdaptiveStim position names and icons on the Therapy screen.   Table 5.5 AdaptiveStim positions on the Therapy screen Group row Parameter Position description Upright or Standing or sitting upright Lying B or Lying on your back English  97740 2015-03-01…

  • Page 129: Turning Adaptivestim On And Off

    AdaptiveStim name display preference (ie, the text may be in another language other than English) Turning AdaptiveStim on and off If AdaptiveStim is turned on, the AdaptiveStim icon ( ) will appear next to the Neurostimulator on icon ( ) in the Status row. 97740 2015-03-01  English …

  • Page 130
    Press the Sync key. The Therapy screen appears. 2. Press the up arrow on the Navigator key to move the selection box to the Status row (Figure 5.14). Status row Figure 5.14  Accessing preferences from the Status row. English  97740 2015-03-01…
  • Page 131
    (shown in Figure 5.15) will be displayed on the preference screen. AdaptiveStim off icon showing Figure 5.15  AdaptiveStim preference screen. 4. Press the Sync key to send the change to your neurostimulator and return to the Therapy screen. 97740 2015-03-01  English …

  • Page 132: Making Adjustments To Adaptivestim

    AdaptiveStim icon or text will blink, indicating the patient programmer has updated to the current AdaptiveStim position. Even with AdaptiveStim enabled, you may need to make adjustments to your stimulation. Table 5.6 provides general guidelines for adjusting your stimulation when using AdaptiveStim. English  97740 2015-03-01…

  • Page 133
    Turn AdaptiveStim off. uncomfortable while moving in an elevator, escalator, etc. You want AdaptiveStim to Adjust your amplitude to turn your therapy off when 0 V to turn your therapy off in a certain position. instead of turning the neurostimulator off. 97740 2015-03-01  English …
  • Page 134
    English  97740 2015-03-01…

  • Page 135: Mri Examinations

    6 MRI examinations…

  • Page 136: If You Have An Mri Appointment

    MRI appointment • If you have a patient identification (ID) card given to you by Medtronic for your implanted neurostimulation system, be sure to bring your most current card to every MRI appointment. The patient ID card shows the MRI…

  • Page 137: At The Mri Appointment

    Bring your patient programmer to every MRI appointment. However, do not take the patient programmer into the MRI scanner (magnet) room. At the MRI appointment • If you have a patient identification (ID) card given to you by Medtronic for your implanted neurostimulation system, 97740 2015-03-01  English …

  • Page 138
    If you do not provide this important information, you may be given an inappropriate MRI scan, which could cause you injury or could cause damage to your implanted medical device. The MRI clinician conducting your English  97740 2015-03-01…

  • Page 139: Placing Your Neurostimulation System In Mri Mode For The Mri Scan

    MRI mode before your MRI scan. MRI mode turns stimulation off. MRI mode can be activated with your Model 97740 patient programmer or with a clinician programmer (if you have a neurostimulator with SureScan MRI Technology). Table 6.1 shows where to go in this chapter for more information.

  • Page 140: Using The Model 97740 Patient Programmer To Activate Mri Mode

    152. Using the Model 97740 patient programmer to activate MRI mode If you brought your Model 97740 patient programmer to the MRI appointment, you can place your neurostimulation system in MRI mode before your MRI scan and outside of the MRI scanner (magnet) room.

  • Page 141: Activating Mri Mode

    1. Synchronize the patient programmer and the neurostimulator. a. Hold the patient programmer directly over your neurostimulator with the screen facing outward. b. Press the Sync key (Figure 6.1). The Therapy screen appears (Figure 6.2 on page 143). 97740 2015-03-01  English …

  • Page 142
    Note: If the patient programmer does not synchronize the first time, try again with the programmer repositioned over the neurostimulator. 2. If needed, press the up arrow on the Navigator key to move the selection box to the Status (top) row (Figure 6.2). English  97740 2015-03-01…
  • Page 143
    Navigator key to move the selection box until the following screen appears: MR Conditional symbol Sync icon Figure 6.3  The MRI mode activation screen. 4. Hold the patient programmer directly over your neurostimulator with the screen facing outward and press the Sync 97740 2015-03-01  English …
  • Page 144
    In addition, one of three screens will appear showing the MRI scan eligibility for your implanted neurostimulation system (Figure 6.4). The display of the MRI scan eligibility screen confirms that your neurostimulation system has been placed in MRI mode and stimulation has been turned off. English  97740 2015-03-01…
  • Page 145
    Serial number of implanted neurostimulator Model number of implanted neurostimulator Information code for MRI clinician to use when contacting Medtronic Technical Support Figure 6.4  Examples of MRI scan eligibility screens. 97740 2015-03-01  English …
  • Page 146
    The implanted neurostimulation system allows the patient to be eligible for MRI scans of the head only using an RF transmit/receive head coil and under other specific conditions. The MRI clinician must consult the MRI guidelines for those conditions. English  97740 2015-03-01…
  • Page 147
    The neurostimulation system MRI scan eligibility cannot be determined. The MRI clinician must consult the MRI guidelines to determine how to proceed or contact Medtronic Technical Support. Information code The code for the MRI clinician to give when contacting Medtronic…

  • Page 148: Turning Stimulation Back On After The Mri Scan

    Turn stimulation back on when the MRI scan is complete and you are outside of the MRI scanner (magnet) room. Turning stimulation back on deactivates MRI mode. Stimulation can be turned on with the patient programmer or the clinician programmer: English  97740 2015-03-01…

  • Page 149
    1. Hold the patient programmer directly over your neurostimulator with the screen facing outward and press the Sync key. 2. Hold the patient programmer over your neurostimulator with the patient programmer screen facing outward and press the Neurostimulator on (Figure 6.5). 97740 2015-03-01  English …
  • Page 150
    Neurostimulator on key Figure 6.5 Neurostimulator on key. 3. Verify that the Neurostimulator on icon ) is displayed on the Status row of the Therapy screen. MRI mode is deactivated when the Therapy screen displays with the Neurostimulator on icon (Figure 6.6). English  97740 2015-03-01…
  • Page 151
    Note: If a power-on-reset (POR) screen appears on the patient programmer, see Table 6.3.   Table 6.3 POR screens Screen Cause and action Error code = POR: Stimulation has stopped. Call your clinician to restart your therapy. Call your clinician 97740 2015-03-01  English …

  • Page 152: For Neurostimulators With Surescan Mri Technology (Models 97702, 97712, 97713, 97714)

    Note: The model number for your implanted neurostimulator is on your patient ID card. If you have a neurostimulator with SureScan MRI Technology, the clinician managing your neurostimulation system can place your neurostimulation system in MRI mode for your MRI examination using the clinician programmer. English  97740 2015-03-01…

  • Page 153
    During the MRI scan, keep your neurostimulation system in MRI mode (stimulation must remain off). After the MRI scan and outside of the MRI scanner (magnet) room, you can turn stimulation back on using your patient programmer or you can return to the clinician 97740 2015-03-01  English …
  • Page 154
    English  97740 2015-03-01…

  • Page 155: Maintenance

    7 Maintenance…

  • Page 156: Patient Programmer Batteries

    Keep the batteries away from children. If children or pets swallow the batteries, contact a doctor at once. Checking the patient programmer batteries You can check the patient programmer batteries at any time. Complete the following English  97740 2015-03-01…

  • Page 157
    Press the Sync key. The Therapy screen appears. 2. Review the patient programmer battery status and battery level. The Therapy screen displays an icon indicating the patient programmer battery level (Figure 7.1). 97740 2015-03-01  English …
  • Page 158
    Patient programmer battery level on the Therapy screen. Table 7.1 lists the screens associated with the patient programmer battery.   Table 7.1 Patient programmer battery screens The patient programmer batteries are depleted. Programming is not possible. Replace the patient programmer batteries now. English  97740 2015-03-01…

  • Page 159: Replacing The Patient Programmer Batteries

    You can finish programming. Replace the patient programmer batteries before the batteries become depleted. Press any arrow on the Navigator key to clear the information screen. Replacing the patient programmer batteries 1. Open the battery compartment cover (Figure 7.2). 97740 2015-03-01  English …

  • Page 160
    Figure 7.2  Opening the battery cover. 2. Remove the depleted batteries. 3. Insert the new batteries as shown on the battery compartment label. 4. Close the battery compartment cover. 5. Dispose of old batteries according to local requirements. English  97740 2015-03-01…

  • Page 161: Cleaning And Care

    Follow all warnings and precautions in Chapter 2 «Important therapy information» and Chapter 11 «Appendix A: Electromagnetic interference (EMI)». • Handle the device with care. Do not drop, strike, or step on the device. • Do not dismantle or tamper with the device. 97740 2015-03-01  English …

  • Page 162: Safety And Technical Checks

    The patient programmer contains no user-serviceable parts. If repair or service is needed, contact your clinician or a Medtronic sales office. Refer to the Medtronic contacts at the end of this manual. English  97740 2015-03-01…

  • Page 163: Battery And Patient Programmer Disposal

    Explanted devices should not be resterilized or reimplanted. We suggest you request that your explanted device be returned to Medtronic for analysis and disposal. Letting us analyze the condition of your device will help us improve future devices. Refer to the back cover for contact…

  • Page 164: Specifications

    9.4 cm × 5.6 cm × 2.8 cm (approximate) (3.7 in × 2.2 in × 1.1 in) Weight, including 111 g (3.9 oz) batteries (approximate) 2 months (average) for Battery life alkaline batteries Mode of operation Continuous Service life Up to 5 years English  97740 2015-03-01…

  • Page 165
    Batteries should be removed from the device for storage or transport.   Table 7.3 Implanted neurostimulation system specifications Description Specifications Typical materials in contact with human tissue  Neurostimulator Titanium Polyurethane Silicone rubber Silicone medical adhesive Polysulfone  Lead Polyurethane Platinum iridium 97740 2015-03-01  English …
  • Page 166
      Table 7.3 Implanted neurostimulation system specifications (continued) Description Specifications Extension Polyurethane For a complete list of materials in contact with human tissue, contact your clinician. English  97740 2015-03-01…

  • Page 167: Troubleshooting

    8  Troubleshooting…

  • Page 168: Patient Programmer Screens

    Warning screens Warning screens indicate a problem with the patient programmer, the antenna, or the neurostimulator. If the patient programmer audio preference is turned on, 3 tones alert you when a warning screen is displayed on the patient programmer. English  97740 2015-03-01…

  • Page 169
    Replace the external Replace external neurostimulator batteries now. neurostimulator Refer to the manual packaged batteries with the external neurostimulator. The patient programmer batteries are depleted. Programming is not possible. Replace the patient Replace patient programmer batteries now. programmer batteries 97740 2015-03-01  English …
  • Page 170
    Device not supported Call your clinician. Error code = EOS: The neurostimulator has reached its end of service. Stimulation is not available. Call your clinician Call your clinician. English  97740 2015-03-01…
  • Page 171
    If the error message appears again, call your clinician. Other codes: The system is not working correctly. Stimulation may have stopped. Write down the code shown Call your clinician on the screen. Call your clinician. 97740 2015-03-01  English …

  • Page 172: Information Screens

    If the patient programmer audio preference is turned on, 3 tones alert you when an information screen is displayed on the patient programmer. Table 8.2 describes the possible information screens and provides instructions on how to proceed (see blue text) when these messages appear. English  97740 2015-03-01…

  • Page 173
    If using the detachable antenna, check that the antenna is connected properly, reposition the antenna and try communication again. To clear the information screen, press any arrow on the Navigator key. 97740 2015-03-01  English …
  • Page 174
    If using the detachable antenna, check that the antenna is connected properly, reposition the antenna and try communication again. To clear the information screen, press any arrow on the Navigator key. English  97740 2015-03-01…
  • Page 175
    The cable to the external neurostimulator is loose or disconnected. Connect the cable to the Disconnected cable external neurostimulator. Turn the patient programmer off then on again. To clear the information screen, press any arrow on the Navigator key. 97740 2015-03-01  English …
  • Page 176
    Replace the external External neurostimulator batteries. neurostimulator Refer to the manual packaged batteries are low with the external neurostimulator. To clear the information screen, press any arrow on the Navigator key. English  97740 2015-03-01…
  • Page 177
    This service screen reappears daily. After clearing this screen, a low battery level icon appears on the Status row of the Therapy screen. To clear the information screen, press any arrow on the Navigator key. 97740 2015-03-01  English …
  • Page 178
    Navigator key. You tried increasing a parameter (amplitude, pulse width, or rate) above the highest value allowed. To clear the information Upper limit reached screen, press any arrow on (amplitude shown) the Navigator key. English  97740 2015-03-01…
  • Page 179
    OOR upper limit Decrease another parameter reached (amplitude before increasing this shown) parameter. Recharge the rechargeable neurostimulator battery (if applicable). Replace the external neurostimulator batteries (if applicable). To clear the information screen, press any arrow on the Navigator key. 97740 2015-03-01  English …
  • Page 180
    Call your clinician to report this message screen. To clear the information screen, turn off your patient programmer. Until your ENS is reconfigured by your clinician, this error message will appear when you attempt to communicate with the ENS. English  97740 2015-03-01…

  • Page 181: Communication Screens

    Screen Description and action The patient programmer is communicating with the external neurostimulator. The patient programmer is communicating with the implanted neurostimulator. Possible problems and solutions Table 8.4 will help you solve problems associated with the patient programmer or 97740 2015-03-01  English …

  • Page 182
    The right column lists possible causes of the problem (see plain text) and how to correct the problem (see bold blue text). Note: If a problem is not solved after several attempts, or if a problem is not described here, contact your clinician. English  97740 2015-03-01…
  • Page 183
    97740 2015-03-01  English …
  • Page 184
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  • Page 185
    97740 2015-03-01  English …
  • Page 186
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  • Page 187
    97740 2015-03-01  English …
  • Page 188
    English  97740 2015-03-01…

  • Page 189: Additional Information

    9 Additional information…

  • Page 190: How Stimulation Works

    (Figure 9.1). Brain senses Brain senses tingling pain and reduced pain Stimulation pulse inhibits pain signal Pain signal Pain signal from foot from foot Figure 9.1  Stimulation blocks pain signals as they move to the brain (spinal cord stimulation shown). English  97740 2015-03-01…

  • Page 191
    Figure 9.2  Sensations with and without stimulation (spinal cord stimulation shown). Generally, people experience a fairly constant sensation of the electrical pulses from stimulation. However, you may feel changes when you suddenly move or change position. 97740 2015-03-01  English …
  • Page 192
    A program defines the amplitude, pulse width, and rate of the stimulation pulse, as well as the specific location, pattern, or position in which the pulse will be delivered. English  97740 2015-03-01…
  • Page 193
    Typically, Alex’s pain doesn’t vary; however, sometimes Alex has additional pain in his right ankle. Alex’s clinician used 3 programs (Program 1, Program 2, and Program 3) to design 2 groups (Group A and Group B) for Alex. 97740 2015-03-01  English …
  • Page 194
    Program 1 Program 2 Program 2 Program 3 Figure 9.3  Example of programs and groups. Your clinician will program specific programs and groups that you will be able to adjust with your patient programmer. Discuss this with your clinician. English  97740 2015-03-01…

  • Page 195: Controlling Your Stimulation

    Talk to your clinician about the settings that apply to your therapy. 97740 2015-03-01  English …

  • Page 196: Possible Adverse Effects

    The lead, extension, or neurostimulator could migrate within the body or erode through the skin. • There could be undesirable changes in stimulation, possibly related to cellular changes around the electrode(s), changes in the position of the electrode(s), loose English  97740 2015-03-01…

  • Page 197
    • In rare cases, excessive tissue growth around the electrode(s) may result in spinal cord compression and paralysis. Additional surgery is required to treat these complications, which can occur weeks to years after lead implantation. 97740 2015-03-01  English …
  • Page 198
    English  97740 2015-03-01…
  • Page 199
    10 User assistance…

  • Page 200: User Assistance

    The patient programmer has been designed and tested to provide trouble-free service. If repair or service is needed, contact your clinician or a Medtronic sales office. Refer to the Medtronic contacts at the end of this manual. The serial number is located in the battery compartment.

  • Page 201: Declaration Of Conformity

    Medtronic declares that this product is in conformity with the essential requirements of Directive 90/385/EEC on Active Implantable Medical Devices and R&TTE Directive 1999/5/EC. For additional information, contact Medtronic. Refer to the list of Medtronic contacts at the end of this manual. 97740 2015-03-01  English …

  • Page 202
    English  97740 2015-03-01…

  • Page 203: Appendix A: Electromagnetic Interference (Emi)

    11 Appendix A: Electromagnetic interference (EMI)

  • Page 204: Contraindication

    Energy from diathermy can be transferred through your implanted system, and can cause tissue damage, resulting in severe injury or death. Diathermy can also damage parts of your neurostimulation system. This can result in loss of therapy from your neurostimulation English  97740 2015-03-01…

  • Page 205
    (lead, extension, neurostimulator) remains in your body. Warnings EMI from the following medical procedures or equipment can damage the device, interfere with device operation, or cause you harm. If these procedures or equipment are required, the guidelines below must be followed: 97740 2015-03-01  English …
  • Page 206
    • Paddles should be positioned as far from the neurostimulator as possible. • Paddles should be positioned perpendicular to the neurostimulation system. • The lowest clinically appropriate energy output (watt seconds) should be used. English  97740 2015-03-01…
  • Page 207
    (requiring your health care provider to reprogram your neurostimulator). When electrocautery is necessary, these precautions must be followed: 97740 2015-03-01  English …
  • Page 208
    (ground plate) should be kept as far away as possible from the neurostimulator, extension, and lead. – full-length operating-room-table grounding pads should not be used. • After electrocautery, your doctor should confirm that the neurostimulator is working as intended. English  97740 2015-03-01…
  • Page 209
    MRI scan. For your MRI scan, the MRI clinician must follow all conditions given in the MRI guidelines for Medtronic neurostimulation systems for chronic pain instructions for use manual. • Full-body eligible MRI scans…
  • Page 210
    MRI using a radio-frequency (RF) transmit body coil or not following the  Please have your health care professional contact Medtronic for the latest MRI guidelines for your neurostimulation system for chronic pain. Contact information is found at the back of this manual, or the health care professional can go to www.medtronic.com/mri.
  • Page 211
    SureScan MRI Technology have been designed to minimize the potential interactions described in this section when the appropriate conditions are followed as given in the MRI guidelines for Medtronic neurostimulation systems for chronic pain instructions for use manual. •…
  • Page 212
    – High MRI specific absorption rate (SAR) RF power levels – Low impedance leads or extensions (Medtronic product names or model numbers designated by a “Z,” an “LZ,” or “low impedance”) – Implanted lead systems with small surface area electrodes –…
  • Page 213
    Device interactions – MRI may affect the operation of the neurostimulator and require reprogramming of the neurostimulator with the clinician programmer after the MRI scan. The MRI may also reset the parameters to power- on-reset (POR) settings, which may also 97740 2015-03-01  English …
  • Page 214
    (such as those found in airports, libraries, and some department stores). When approaching these devices, do the following: 1. Show the security personnel your patient identification card for the neurostimulator and ask for a manual search. Security English  97740 2015-03-01…
  • Page 215
    (Figure 11.1). a. If two security gates are present, walk through the middle, keeping as far away as possible from each gate. b. If one gate is present, walk as far away as possible from it. 97740 2015-03-01  English …
  • Page 216
    4. After you pass through the security device, turn your neurostimulator on again. Precautions EMI from the following equipment is unlikely to affect your neurostimulation system if the guidelines below are followed: English  97740 2015-03-01…
  • Page 217
    15 cm (6 in) away from the neurostimulator. Electromagnetic field devices—The following equipment or environments should be avoided: • Antennas of citizen band (CB) or ham radios • Electric arc welding equipment 97740 2015-03-01  English …
  • Page 218
    Perfusion systems • Resistance welders • Television and radio transmitting towers (safe if outside the fenced area) If you suspect that equipment is interfering with the neurostimulation system do the following: 1. Move away from the equipment or object. English  97740 2015-03-01…
  • Page 219
    Psychotherapeutic procedures—Safety has not been established for psychotherapeutic procedures using equipment that generates electromagnetic interference (eg, electroconvulsive therapy, transcranial magnetic stimulation) in patients who have an implanted neurostimulation system. Induced electrical currents may 97740 2015-03-01  English …

  • Page 220: Notes

    TENS unit might be interfering with your neurostimulator, discontinue using the TENS until you talk with your doctor. Notes Household items—Most household appliances and equipment that work properly and are properly grounded will not interfere with the neurostimulation system. The English  97740 2015-03-01…

  • Page 221
    Radio-frequency sources (AM/FM radios, cellular telephones, and cordless and conventional telephones): Keep these items at least 10 cm (4 in) away from the implanted neurostimulator. • Sewing machines or salon hair dryer: Keep the neurostimulator away from the motors. 97740 2015-03-01  English …
  • Page 222
    Diagnostic x-rays or fluoroscopy Note: Tight pressure in the area of your neurostimulator, such as used during mammography, may damage or disconnect components of your neurostimulation system. This may require surgery to replace or repair the neurostimulation system. X-ray equipment English  97740 2015-03-01…
  • Page 223
    • Magnetoencephalography (MEG) • Positron emission tomography (PET) scans Therapeutic magnets—Keep therapeutic magnets at least 25 cm (10 in) away from your neurostimulator. Magnetic fields of 10 gauss or less will generally not affect the neurostimulator. 97740 2015-03-01  English …

  • Page 224: Index

    124-129 enabled icon 61 guidelines for adjusting 133 icon 124 making adjustments 132 off icon 131 positions 126-129 turning on and off 129 Adjusting stimulation guidelines for 100-103 settings 100-103 Adverse effects 196 Amplitude description 192 GroupAdjust 116 English  97740 2015-03-01…

  • Page 225
    100, 168, 172 Backlight (Power/Backlight) key 66 Batteries (external neurostimulator) checking battery level 72 low battery level screen 176 replace warning screen 169 Batteries (patient programmer) about 156 checking 156 disposing of 163 replacing 159 Battery charge level (low) screen 176 97740 2015-03-01  English …
  • Page 226
    170 Battery level (low) screen external neurostimulator 176 implanted nonrechargeable neurostimulator 177 patient programmer 177 Bone growth stimulators 217 Burial 163 Cardiac devices 42, 43, 45 Cardioversion 206 Carrying case, patient programmer 89 CAT scans 206 Cell phones 220 English  97740 2015-03-01…
  • Page 227
    75 patient programmer 156 Clinician programmer 195 Clinician settings, returning to 108 Clinician, when to call 54, 200 Communication screens 181 Complications, system 196 Computer disk drives 220 Configure ENS error error screen 180 Contraindications 34 Contrast preference 81-89 97740 2015-03-01  English …
  • Page 228
    Disposing of implanted neurostimulator 163 patient programmer batteries 163 patient programmer 163 Driving 48 Electrocautery 207 Electrolysis 217 Electromagnetic field devices 217 Electromagnetic interference (EMI) 36 Error codes 0 to 252 171 Configure ENS error 180 EOS 170 ERI 177 English  97740 2015-03-01…
  • Page 229
    GroupAdjust 116 Group changing and making active 111 description 193 Group name displaying with icon or text 114 icon or text definitions 114 Group row description 61 icons 62 Hair dryer 220 Hiking 48 Household items 220 Hyperbaric chambers 47 97740 2015-03-01  English …
  • Page 230
    Neurostimulator (implanted rechargeable) Increase key 66, 106 Increasing a parameter 104-108 Indications 29 Induction range 220 Information screens 172-180 Interference see Electromagnetic interference (EMI) Itrel 4 neurostimulator see Neurostimulator (implanted nonrechargeable) Keys (patient programmer) 64 Laser procedures 219 Leads 33 English  97740 2015-03-01…
  • Page 231
    Lower parameter limit screens 107 Magnetic resonance imaging (MRI) 136, 209 Magnetic strip 220 Magnetoencephalography (MEG) 223 Magnets, therapeutic 223 Mammography 222 Medical procedure, what to do 204 Microwave ablation 214 Model number of implanted neurostimulator, where to find 29 97740 2015-03-01  English …
  • Page 232
    MRI mode activating with clinician programmer 152 activating with patient programmer 140, 141 deactivating 148 description 139, 144 MRI scan eligibility screens 144-145 MRI scan eligibility icons 146 screens 144-145 types of 136 Navigator key 65, 68 Neurostimulation system (implanted) specifications 165 English  97740 2015-03-01…
  • Page 233
    177 model numbers 28 turning on or off 70 Neurostimulator (implanted rechargeable) battery charge level warning screen 170 charging the battery 74 checking battery charge level 75 description 31 disposing of 163 low battery charge level screen 176 97740 2015-03-01  English …
  • Page 234
    65 Number format preference 81-89 OOR (out of regulation) error screen 180 parameter limit screens 108 Options icon 68 Overdischarged neurostimulator battery 75 Parameter, increasing or decreasing 104-108 Parameter limit screens 106-108 Parameter row description 63 icons 63 English  97740 2015-03-01…
  • Page 235
    57 keys 64 low battery level screen 177 preferences 81-89 purpose 28 repair 162, 200 replace batteries warning screen 169 replacing batteries 159 screens 168-181 specifications 164 troubleshooting 181-187 turning on and off 66 Pediatric use 49 PET scans 223 97740 2015-03-01  English …
  • Page 236
    223 Power/Backlight key 66 Power tools 220 Precautions 43 Preferences, changing 81-89 Preference settings icons 81 Pregnancy 49 PrimeAdvanced neurostimulator see Neurostimulator (implanted nonrechargeable) PrimeAdvanced with SureScan MRI Technology neurostimulator see Neurostimulator (implanted nonrechargeable) Programmer see Patient programmer English  97740 2015-03-01…
  • Page 237
    104-108 Radiation therapy 220 Radio-frequency (RF) ablation 214 Radios 220 Rate description 192 guidelines for adjusting 100-103 icon 64 increasing or decreasing 104-108 in programs within a group 106 Recovery from surgery 52 Refrigerator 220 Repair 162 97740 2015-03-01  English …
  • Page 238
    Technology neurostimulator see Neurostimulator (implanted rechargeable) Restore neurostimulator see Neurostimulator (implanted rechargeable) RestorePrime neurostimulator see Neurostimulator (implanted nonrechargeable) RestoreSensor neurostimulator see Neurostimulator (implanted rechargeable) RestoreSensor with SureScan MRI Technology neurostimulator see Neurostimulator (implanted rechargeable) RestoreUltra neurostimulator see Neurostimulator (implanted rechargeable) English  97740 2015-03-01…
  • Page 239
    Security screening devices 214 Selection box 68 Serial number, patient programmer 200 Settings, adjusting stimulation 100-103 Sewing machines 220 Skiing 48 Skydiving 48 SoftStart/Stop 186 Specifications neurostimulation system (implanted) 165 patient programmer 164 Status row description 59 icons 60 Stereo speakers 220 97740 2015-03-01  English …
  • Page 240
    100-103 troubleshooting 183-185 uncomfortable 183 unexpected changes 103 Storm doors 220 Surgery recovery 52 risks 35 Synchronize warning screen 169 Synchronizing description 56 function 65 how to 67 Sync key 65, 66 TargetMyStim 121 Test stimulation 31 Theft detectors 214 English  97740 2015-03-01…
  • Page 241
    Turning neurostimulator on or off 65, 70 Twiddler’s syndrome 47 Ultrasonic probes 217 Ultrasonics, high-output 209 Ultrasound, diagnostic 222 Uncomfortable stimulation 71, 104 troubleshooting 183 Unexpected changes in stimulation 52, 103 Unexpected stimulation 48, 71, 104 Upper parameter limit screens 107 Warning screens 168-171 Warnings 35-43 97740 2015-03-01  English …
  • Page 242
    X-rays, diagnostic 222 English  97740 2015-03-01…
  • Page 243
    97740 2015-03-01  English …
  • Page 244
    Fax (1786)-709-4244 Belgium: Medtronic Belgium S.A. Norway: Medtronic Norge AS Tel. 02-456-0900 Tel. 67-10-32-00 Fax 02-460-2667 Fax 67-10-32-10 Canada: Medtronic of Canada Ltd. Poland: Medtronic Poland Sp. z.o.o. Tel. (1-905)-460-3800 Tel. (022)-465-69-00 Fax (1905)-826-6620 Fax (022)-465-69-17 Czech Republic: Medtronic Czechia Portugal: Medtronic Portugal, Lda.
  • Page 245
    The Netherlands: Medtronic B.V. USA: Medtronic, Inc. Tel. (045)-566-8000 Tel. (1-763)-505-5000 Fax (045)-566-8668 Fax (1-763)-505-1000 Toll-free: (1-800)-328-0810 Turkey: Medtronic Turkey Tel. +90 216 636 1000 Fax +90 216 636 1008 U.K.: Medtronic U.K. Ltd. Tel. 01923-212213 Fax 01923-241004  …
  • Page 246
    European Community Medtronic B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31, Case Postale 84 CH — 1131 Tolochenaz, Switzerland www.medtronic.eu Tel. +41-21-802-7000 Fax +41-21-802-7900 Asia-Pacific Medtronic International Ltd.

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