Medtronic mystim 97740 инструкция на русском - Самые разные инструкции по применению

Contents
Table of Contents
Troubleshooting
Bookmarks

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

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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

Related Manuals for Medtronic 97740

Summary of Contents for Medtronic 97740

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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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, 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 …
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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 …
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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…
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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 …
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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…
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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…
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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…
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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 …
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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…
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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 …
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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…
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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 …
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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…
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• 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…
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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.
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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.
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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 …
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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…
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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 …
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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…
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(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 …
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(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…
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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 …
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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 …
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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…
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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 …
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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…
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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 …
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(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 …
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• 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…
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• 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…
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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…
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(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 …
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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 …
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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…
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• 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…
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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…
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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…
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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…
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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…
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(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 …
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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…
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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 …
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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 …
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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 …
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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…
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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 …
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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…
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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 …
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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…
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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 …
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– 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 …
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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 …
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(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…
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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 …
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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…
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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…
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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 …
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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…
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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 …
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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…
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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…
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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 …
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– 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…
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(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…
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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 …
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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 …
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(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…
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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…
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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…
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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 …
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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 …
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• 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 …
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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…
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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…
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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…
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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 …
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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
English 97740 2015-03-01…
Page 185
97740 2015-03-01 English …
Page 186
English 97740 2015-03-01…
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.

Источник

Medtronic

, AdaptiveStim

, GroupAdjust

, Itrel

PrimeAdvanced

, Restore

, RestoreAdvanced

RestorePrime

, RestoreSensor

, RestoreUltra

SoftStart/Stop

, SureScan

, and TargetMyStim

are

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. Operation is

subject to the following two conditions: (1) this device

may not cause harmful interference and (2) this device

must accept any interference received, including

interference that may cause undesired operation.

IMPORTANT: Changes or modifications to this

product not authorized by Medtronic, Inc., could

void the FCC Certification and negate your

authority to operate this product.

This device complies with Industry Canada license-

exempt RSS standard(s). Operation is subject to the

following two conditions: (1) this device may not cause

interference, and (2) this device must accept any

interference, including interference that my cause

undesired operation of the device.

Источник

Download or browse on-line these Operation & User’s Manual for Medtronic MyStim 97740 Health Care Products, Medical Equipment.

Summary of Contents:

[Page 1] Medtronic MyStim 97740

PATIENT PROGRAMMER 97740 Pain therapy user manual for neurostimulation system models 37022, 37701, 37702, 37703, 37704, 37711, 37712, 37713, 37714, 97702, 97712, 97713, 97714 ! USA Rx only 2013 Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″…

[Page 2] Medtronic MyStim 97740

Medtronic ® , AdaptiveStim ® , GroupAdjust ® , Itrel ® , PrimeAdvanced ® , Restore ® , RestoreAdvanced ® , RestorePrime ® , RestoreSensor ® , RestoreUltra ® , SoftStart/Stop ® , SureScan ® , and TargetMyStim ® are trademarks of Medtroni…

[Page 3] Medtronic MyStim 97740

Label Symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC…

[Page 4] Medtronic MyStim 97740

PIN No. PIN number Keep dry Ingress protection rating IP22, per 60601-1-11 MR Magnetic Resonance (MR) Unsafe System meets the applicable Canadian (CAN/CSA-C22.2 No. 60601-1) electrical safety standard requirements. Chinese Standard (SJ/T11364-2006) L…

[Page 5] Medtronic MyStim 97740

Table of contents Label Symbols 3 Glossary 12 1 Introduction 20 How to use this manual 20 Patient guides 22 Patient identification card 25 2 Important therapy information 28 Purpose of the device 28 Purpose of the neurostimulati…

[Page 6] Medtronic MyStim 97740

Individualization of Treatment 49 3 Recovery and care after surgery 52 Recovery from surgery 52 Activities 52 When to call your clinician 54 Care schedule 54 4 Using your patient programmer 56 How the patient programmer works 56…

[Page 7] Medtronic MyStim 97740

Checking the external neurostimulator battery 72 Checking the implanted rechargeable neurostimulator battery 74 Checking the implanted nonrechargeable neurostimulator battery 79 Changing patient programmer preferences 81 Using the carrying case a…

[Page 8] Medtronic MyStim 97740

(Models 37022, 37701, 37702, 37711, 37712, 37713, 37714, 97702, 97712, 97713, 97714) 111 Displaying group names 114 Using GroupAdjust 116 (Models 37022, 37702, 37712, 37713, 37714, 97702, 97712, 97713, 97714) 116 Viewing Scheduled Therapy 119 (M…

[Page 9] Medtronic MyStim 97740

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 For neu…

[Page 10] Medtronic MyStim 97740

Specifications 164 8 Troubleshooting 168 Patient programmer screens 168 Warning screens 168 Information screens 172 Communication screens 181 Possible problems and solutions 181 9 Additional information 190 How stimulation works…

[Page 11] Medtronic MyStim 97740

Warnings 205 Precautions 216 Notes 220 Index 224 97740 2015-03-01 English Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl — PatientProgrammerTemplate.fm Template version 6…

[Page 12] Medtronic MyStim 97740

Glossary Caution — A statement describing actions that could result in damage to or improper functioning of a device. Clinician — A healthcare professional such as a doctor or nurse. Clinician programmer — A device used by a clinician to send instruc…

[Page 13] Medtronic MyStim 97740

Diathermy — A medical treatment applied to the outside of the body that delivers energy into the body. Three types of energy that can be used are shortwave, microwave, and ultrasound. Depending on the power level used, diathermy devices may or may no…

[Page 14] Medtronic MyStim 97740

ERI (Elective replacement indicator) — The neurostimulator is nearing scheduled end of service. Group — Combined programs that provide stimulation to one or more pain sites. Each group may be defined for a different activity, symptom, or time of day….

[Page 15] Medtronic MyStim 97740

Neurostimulator — The power source of a neurostimulation system. It contains the battery and electronics that control the stimulation you feel. An external neurostimulator is carried outside the body. During test stimulation, it is used to determine …

[Page 16] Medtronic MyStim 97740

POR (Power on reset) — The neurostimulator battery has caused the electronic circuitry in the neurostimulator to be reset. Precaution — See Caution. Program — Stimulation directed to a specific pain site. Recharger — The component of the neurostimula…

[Page 17] Medtronic MyStim 97740

Stimulation — The delivery of electrical pulses to the area where pain signals are blocked as they move to the brain. Stimulation blocks some pain signals from reaching the brain. Stimulation settings — Refers to all the features assembled to define …

[Page 18] Medtronic MyStim 97740

Therapy impedance measurements — Impedance and stimulation current measurements taken at the programmed settings. Therapy settings — A specific combination of amplitude, rate, and pulse width parameters acting on a specific electrode set that determi…

[Page 19] Medtronic MyStim 97740

1 Introduction Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl — PatientProgrammerTemplate.fm Template version 6.2: 12-03-2014 M940177A012 Rev X 2015-03-01
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[Page 20] Medtronic MyStim 97740

How to use this manual Use this manual during test stimulation and after receiving an implanted neurostimulator. Ask your clinician to explain anything that is unclear. • A glossary is included at the beginning of this manual. • Chapter 1 «I…

[Page 21] Medtronic MyStim 97740

• Chapter 4 «Using your patient programmer» describes the patient programmer and how to perform specific tasks. • Chapter 5 «Adjusting your stimulation» describes how to adjust your stimulation using your patient programmer. �…

[Page 22] Medtronic MyStim 97740

adverse effects, changes in therapy, and possible system complications. • Chapter 10 «User assistance» describes where to find the patient programmer serial number and who to contact if the patient programmer is lost or broken. • Chapte…

[Page 23] Medtronic MyStim 97740

37022 External Neurostimulator: Test Stimulation Patient Guide. This manual describes the goals, activities, components, and instructions for test stimulation. Table 1.1 Patient guides for an implanted neurostimulator Patient guide Rechargeabl…

[Page 24] Medtronic MyStim 97740

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 rechargeabl…

[Page 25] Medtronic MyStim 97740

Patient identification card When you leave the hospital, your doctor will give you a patient identification card. This card supplies information about you, your implanted device, and your doctor. Your identification card may allow you to bypass secur…

[Page 26] Medtronic MyStim 97740

English 97740 2015-03-01 Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl — PatientProgrammerTemplate.fm Template version 6.2: 12-03-2014 M940177A012 Rev X 2015-03-01 26 Intro…

[Page 27] Medtronic MyStim 97740

2 Important therapy information Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl — PatientProgrammerTemplate.fm Template version 6.2: 12-03-2014 M940177A012 Rev X 2015-03-01
…

[Page 28] Medtronic MyStim 97740

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 …

[Page 29] Medtronic MyStim 97740

• PrimeAdvanced with SureScan MRI Technology Model 97702 • Itrel 4 Models 37703 and 37704 Refer to your patient identification card to determine the model number of your neurostimulator. Purpose of the neurostimulation system (indications) Refer …

[Page 30] Medtronic MyStim 97740

• a neurostimulator • 1 or 2 leads • 1 or 2 extensions (optional) Neurostimulator Extensions Leads Electrodes Figure 2.1 Implanted parts of a typical neurostimulation system (spinal cord stimulation shown). A typical neurostimulation system…

[Page 31] Medtronic MyStim 97740

Charging system (rechargeable neurostimulator) Patient programmer Carrying case Detachable antenna (optional) Figure 2.2 External parts of a typical neurostimulation system. Neurostimulator – The neurostimulator is the power source (battery)…

[Page 32] Medtronic MyStim 97740

an implanted neurostimulator is the right choice for you. Note: Some implanted neurostimulator models include a rechargeable battery. Rechargeable neurostimulators • Restore Model 37711 • RestoreUltra Model 37712 • RestoreUltra with SureScan MR…

[Page 33] Medtronic MyStim 97740

• PrimeAdvanced with SureScan MRI Technology Model 97702 • Itrel 4 Models 37703 and 37704 Lead(s) – A lead is a set of thin wires, covered with a protective coating. A lead has small metal electrodes near the tip. The electrodes transmit electr…

[Page 34] Medtronic MyStim 97740

implanted rechargeable neurostimulator battery. Therapies that may not be used with the neurostimulation system (contraindications) Diathermy—Inform anyone treating you that you CANNOT have any shortwave diathermy, microwave diathermy or therapeuti…

[Page 35] Medtronic MyStim 97740

will not cure your pain. It can, however, reduce your pain to a tolerable level and allow you to resume many of your daily activities. Risks of surgery Implanting a neurostimulation system has risks similar to spinal procedures, including spinal flui…

[Page 36] Medtronic MyStim 97740

devices and magnets encountered in a normal day are unlikely to affect the operation of a neurostimulator. However, sources of strong EMI can result in the following: • Serious patient injury or death, resulting from heating of the implanted compon…

[Page 37] Medtronic MyStim 97740

stimulation or intermittent stimulation, which some patients have described as a jolting or shocking sensation. Although the unexpected change in stimulation may feel uncomfortable, it does not damage the device or injure a patient directly. In rare …

[Page 38] Medtronic MyStim 97740

Table 2.1 Potential effects of EMI from devices or procedures Device or procedure Serious patient injury Device damage Device turns off/on Momentary increase in stimulation Intermittent stimulation Bone growth stimulators XXX CT scans X Defibr…

[Page 39] Medtronic MyStim 97740

Table 2.1 Potential effects of EMI from devices or procedures (continued) Device or procedure Serious patient injury Device damage Device turns off/on Momentary increase in stimulation Intermittent stimulation Electromagnetic field devices (eg…

[Page 40] Medtronic MyStim 97740

[Page 41] Medtronic MyStim 97740

[Page 42] Medtronic MyStim 97740

Case damage—If the neurostimulator case is ruptured or pierced due to outside forces, severe burns could result from exposure to the battery chemicals. Neurostimulator interaction with implanted cardiac devices—When a neurostimulator and an impla…

[Page 43] Medtronic MyStim 97740

program your neurostimulator to a bipolar configuration and a minimum rate of 60 Hz. The cardiac device should be programmed to bipolar sensing. Precautions System and therapy Clinician programmer interaction with a cochlear implant—If you have a c…

[Page 44] Medtronic MyStim 97740

• the radio-frequency (RF) signal used to program either device can reset or reprogram the other device • the magnet in a cardiac programmer can activate magnetically controlled functions in the neurostimulator. To verify that inadvertent program…

[Page 45] Medtronic MyStim 97740

another device (eg, pacemaker, defibrillator, another neurostimulator). The patient control device could accidently change the operation of another device. Patient programmer handling—To avoid damaging the patient programmer, do not immerse the dev…

[Page 46] Medtronic MyStim 97740

generate electromagnetic interference (EMI) or turn off the likely source of EMI. EMI may disrupt communication between the patient programmer and neurostimulator. Examples of EMI sources are computer monitors, cellular telephones, and motorized whee…

[Page 47] Medtronic MyStim 97740

of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery. Spinal cord stimulation patients, in particular, should avoid excessive bending of the torso. Component manipulation (twiddler’s syndrome)—Do not …

[Page 48] Medtronic MyStim 97740

Skydiving, skiing, or hiking in the mountains—High altitudes should not affect the neurostimulator; however, you should consider the movements involved in any planned activity and take precaution to not put undue stress on your implanted system. Du…

[Page 49] Medtronic MyStim 97740

Individualization of Treatment Patient management—Best results are achieved when you are fully informed about the therapy risks and benefits, surgical procedure, follow-up requirements, and self- care responsibilities. Maximum benefits from the neu…

[Page 50] Medtronic MyStim 97740

• Pregnancy, unborn fetus, or delivery • Pediatric use (patients under the age of 18) English 97740 2015-03-01 Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl — PatientProgra…

[Page 51] Medtronic MyStim 97740

3 Recovery and care after surgery Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl — PatientProgrammerTemplate.fm Template version 6.2: 12-03-2014 M940177A012 Rev X 2015-03-01
…

[Page 52] Medtronic MyStim 97740

Recovery from surgery It takes several weeks to heal from surgery. It is normal to feel some discomfort from the incision(s) and to have some pain at the implant site for 2 to 6 weeks. Your doctor may also prescribe physical therapy or medication to …

[Page 53] Medtronic MyStim 97740

• Avoid lying on your stomach. • Avoid reaching over your head. • Avoid turning from side to side. • Avoid bending forward, backward, or from side to side. • Avoid lifting more than 2 kilograms (5 pounds). As you begin to feel better, you s…

[Page 54] Medtronic MyStim 97740

surgery. Discuss your activity level with your doctor. When to call your clinician Contact your clinician if any of the following events occur: • You have pain, redness, or swelling at the incision(s) later than 6 weeks after surgery. • You feel …

[Page 55] Medtronic MyStim 97740

4 Using your patient programmer Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl — PatientProgrammerTemplate.fm Template version 6.2: 12-03-2014 M940177A012 Rev X 2015-03-01
…

[Page 56] Medtronic MyStim 97740

How the patient programmer works The patient programmer communicates with your neurostimulator by sending signals to and receiving signals from the neurostimulator. Your neurostimulator only accepts communications from the patient programmer or clini…

[Page 57] Medtronic MyStim 97740

• An optional detachable external antenna is available for patients who have difficulty reaching their neurostimulator (refer to page 91). Patient programmer with internal antenna Neurostimulator Figure 4.1 Placing the patient programmer over t…

[Page 58] Medtronic MyStim 97740

Notes: • The patient programmer can be used with all the neurostimulator models referenced in this manual; however, the available functions will be different for each model. Be sure to note when a specific neurostimulator model is referenced to det…

[Page 59] Medtronic MyStim 97740

Rechargeable Nonrechargeable Figure 4.2 Therapy screen. The information that appears on the Therapy screen may be different for each patient. The information depends on which neurostimulator you have and how your clinician has programmed your neuro…

[Page 60] Medtronic MyStim 97740

Rechargeable Nonrechargeable Status row Figure 4.3 Status row on Therapy screen. Icons on the Status row indicate the neurostimulator on or off status and the patient programmer battery level status. If you have a rechargeable neurostimulator, the …

[Page 61] Medtronic MyStim 97740

Table 4.1 Status row icons (continued) Icon Description Neurostimulator is on and AdaptiveStim is enabled Implanted rechargeable neurostimulator battery charge level The implanted rechargeable neurostimulator battery charge level is low The im…

[Page 62] Medtronic MyStim 97740

Rechargeable Nonrechargeable Group row Figure 4.4 Group row on Therapy screen. The icons on the Group row indicate the name of the group and whether or not the group is active. Refer to Table 4.2 for a description of the icons that may appear on th…

[Page 63] Medtronic MyStim 97740

Parameter row The Parameter row is the bottom row of the Therapy screen (Figure 4.5). Rechargeable Nonrechargeable Parameter row Figure 4.5 Parameter row on Therapy screen. The icons on the Parameter row indicate the parameter settings currently i…

[Page 64] Medtronic MyStim 97740

Table 4.3 Parameter row icons (continued) Icon Description Pulse width Rate GroupAdjust 1 TargetMyStim … AdaptiveStim position Patient programmer keys Neurostimulator on Neurostimulator off Navigator Sync IncreaseDecrease Power / Backlight…

[Page 65] Medtronic MyStim 97740

Table 4.4 Patient programmer keys Key Function Sync • Synchronizes the neurostimulator and patient programmer. • Activates a selected group. • The patient programmer must be held over the neurostimulator while pressing the Sync key. Na…

[Page 66] Medtronic MyStim 97740

Table 4.4 Patient programmer keys (continued) Key Function Power / Backlight • Pressing and releasing this key turns the patient programmer on or off. • Pressing and holding this key turns the backlight on or off permanently. Normally, the…

[Page 67] Medtronic MyStim 97740

Sync key Figure 4.7 Sync key. Synchronizing sends the settings from your neurostimulator to the patient programmer. All communication with the neurostimulator begins with synchronization. After synchronization, the Therapy screen appears. To synchr…

[Page 68] Medtronic MyStim 97740

Using the Navigator key Use the Navigator key (Figure 4.8) to navigate between and across the rows on the Therapy screen. Figure 4.8 Navigator key. The selection box on the Therapy screen acts as a cursor to show which row is selected for programmi…

[Page 69] Medtronic MyStim 97740

Selection box Options icon Figure 4.9 Options icon and selection box. The Navigator key moves the selection box. The arrows on the Navigator key indicate the direction the selection box will move. • To move the selection box between rows, press t…

[Page 70] Medtronic MyStim 97740

Turning your neurostimulator on or off Complete the following steps to turn the neurostimulator on or off. Note: Turning your neurostimulator on or off also synchronizes the patient programmer and neurostimulator. 1. Hold the patient programmer over …

[Page 71] Medtronic MyStim 97740

On Off Figure 4.10 Turning your neurostimulator on or off. Caution: To prevent possible uncomfortable or unexpected stimulation (jolting or shocking sensation) when stimulation is turned on, decrease all amplitudes to the lowest setting before …

[Page 72] Medtronic MyStim 97740

How to maintain the neurostimulator batteries It is very important that you maintain your neurostimulator batteries, whether you have an external, an implanted rechargeable, or an implanted non-rechargeable neurostimulator. Though you will not need t…

[Page 73] Medtronic MyStim 97740

a. Hold the patient programmer directly over the neurostimulator with the screen facing outward. b. Press the Sync key. The Therapy screen appears. 2. Review the external neurostimulator battery level on the Therapy screen (Figure 4.11). Battery le…

[Page 74] Medtronic MyStim 97740

Table 4.5 External neurostimulator battery message screens The external neurostimulator batteries are depleted and stimulation is not available. Replace the external neurostimulator batteries now. Refer to the manual packaged with the external…

[Page 75] Medtronic MyStim 97740

Note: This section applies only to a neurostimulator with a rechargeable battery. If your neurostimulator is nonrechargeable, continue with «Checking the implanted nonrechargeable neurostimulator battery». Check the implanted rechargeable n…

[Page 76] Medtronic MyStim 97740

neurostimulator in one of the following ways: • Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced. • Battery function is not restored and the neurostimulator must be surgically…

[Page 77] Medtronic MyStim 97740

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. 2. Review the implanted rechargeable batt…

[Page 78] Medtronic MyStim 97740

When the implanted rechargeable neurostimulator battery charge level is low, charge the battery as described in the manual packaged with the charging system. Your implanted rechargeable neurostimulator battery can be charged many times; however, even…

[Page 79] Medtronic MyStim 97740

Checking the implanted nonrechargeable neurostimulator battery (Models 37701, 37702, 37703, 37704, 97702) Complete the following steps to check the implanted nonrechargeable neurostimulator battery. 1. Synchronize the patient programmer and neurostim…

[Page 80] Medtronic MyStim 97740

When the battery in an implanted nonrechargeable neurostimulator is nearing depletion, the neurostimulator must be replaced to continue receiving stimulation. Surgery is required to replace the implanted nonrechargeable neurostimulator. Table 4.7…

[Page 81] Medtronic MyStim 97740

Changing patient programmer preferences Patient programmer preferences affect the way information displays on the screen or the way alert tones sound. These patient programmer preferences include audio, contrast, time, time/number format, and group n…

[Page 82] Medtronic MyStim 97740

Table 4.8 Preference settings icons (continued) Icons Preference Abc… AdaptiveStim name display Return to clinician settings a (see page 108) AdaptiveStim enabled a (see page 129) a Changing these preferences will change your stimulation set…

[Page 83] Medtronic MyStim 97740

2. Press the up arrow on the Navigator key to move the selection box to the Status row (Figure 4.13). Status row Figure 4.13 Accessing preferences from the Status row. 3. Press the left or right arrow on the Navigator key to move the selecti…

[Page 84] Medtronic MyStim 97740

Change row Figure 4.15 Changing the desired preference from the change row. 5. Follow the steps in Table 4.9 to change the selected preference. Table 4.9 Changing patient programmer preferences Audio 1. Press the left or right arrow on …

[Page 85] Medtronic MyStim 97740

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 or darker . 2. Go to step 6, page 88. 97740 2015-03-01 English Filename …

[Page 86] Medtronic MyStim 97740

Table 4.9 Changing patient programmer preferences (continued) Time 1. Press the left or right arrow on the Navigator key to move the selection box to the hour, minutes, or time of day (A or P). 2. Press the Increase or Decrease key to …

[Page 87] Medtronic MyStim 97740

Table 4.9 Changing patient programmer preferences (continued) Time and number format 1. Press the left or right arrow on the Navigator key to move the selection box to a 12-hour clock and numbers with decimals or a 24-hour clock and number…

[Page 88] Medtronic MyStim 97740

Table 4.9 Changing patient programmer preferences (continued) Abc… AdaptiveStim name display (Refer to page 126 for more information about AdaptiveStim names.) 1. Press the left or right arrow on the Navigator key to move the selection b…

[Page 89] Medtronic MyStim 97740

Note: The preference change is sent to the neurostimulator at the next synchronization. 7. Press the left or right arrow on the Navigator key to move to another preference or return to the Therapy screen. Using the carrying case and labeling the …

[Page 90] Medtronic MyStim 97740

Figure 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…

[Page 91] Medtronic MyStim 97740

Using the detachable antenna A detachable antenna (Model 37092) is available if you have difficulty reaching the neurostimulator. It is also useful for viewing the patient programmer screen while you are adjusting stimulation. Complete the following …

[Page 92] Medtronic MyStim 97740

2. Pull the fabric of your clothing through the large opening in the antenna. Then, wedge the fabric in the narrow slit to secure the antenna in place (Figure 4.19). ab Figure 4.19 Pull the fabric through the slit (a) and wedge in place (b). 3. Pu…

[Page 93] Medtronic MyStim 97740

Figure 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….

[Page 94] Medtronic MyStim 97740

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 Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) …

[Page 95] Medtronic MyStim 97740

5 Adjusting your stimulation Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl — PatientProgrammerTemplate.fm Template version 6.2: 12-03-2014 M940177A012 Rev X 2015-03-01
…

[Page 96] Medtronic MyStim 97740

Introduction Various features are available for adjusting your stimulation. Each type or model of neurostimulator provides a unique set of stimulation features. Stimulation features Using the basic neurostimulation features, you can adjust the rate, …

[Page 97] Medtronic MyStim 97740

Table 5.1 Stimulation features available for neurostimulator models a Model Groups Clinician settings b Scheduled therapy Group Adjust Target MyStim Adaptive Stim 37022 Yes Yes Yes Yes Yes 37701 Yes Yes 37702 Yes Yes Yes Yes Yes 37711 Yes Yes…

[Page 98] Medtronic MyStim 97740

Table 5.1 Stimulation features available for neurostimulator models a Model Groups Clinician settings b Scheduled therapy Group Adjust Target MyStim Adaptive Stim a Neurostimulator models 37703 and 37704 do not provide the stimulation feature…

[Page 99] Medtronic MyStim 97740

Notes: • See «Viewing and changing a group» for more information about Groups and «Using GroupAdjust» for more information about GroupAdjust. • See «Using TargetMyStim» for more information about TargetMyStim. Adjust…

[Page 100] Medtronic MyStim 97740

There is often more than one way to change stimulation settings. These instructions describe the most common ways. Notes: • Ask your clinician to print a report with your programmed settings. • When a stimulation setting is changed, you will see …

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AREA OF GLUE

MyStim® Programmer

QUICK GUIDE FOR CHRONIC PAIN

MODEL 97740

Programmer Keys

Programmer Screen Overview

Programmer Functions

NEUROSTIMULATOR ON

• Turns neurostimulation on.

NEUROSTIMULATOR OFF

• Turns neurostimulation o.

SYNC

• Communicates with neurostimulator.

• Press at the beginning of each

session or to activate a new group.

POWER

• Turns programmer on and o.

• Holding key down turns screen backlight

on or o.

NAVIGATOR KEYPAD

• Press up

and down

keys to move

the selection box to desired row.

• Press left

and right

keys to see

additional options in a desired row

(if your doctor has made them available).

MyStim

Programmer

QUICK GUIDE FOR CHRONIC PAIN

Model 97740

INCREASE

• Increases a parameter.

DECREASE

• Lowers a parameter.

Selection box

• Shows which row is selected.

Parameter row

• Shows icons and settings for

program’s parameters that you

can change.

• Options icon

appears only when

other parameters are available.

Amplitude

Changes how strong the stimulation feels

or the spread of the stimulation area.

Pulse Width

Changes how strong the stimulation feels

or the spread of the stimulation area.

Rate

Changes how smooth the stimulation feels.

Rate feels like “tapping.”

Amplitude Group Adjust

Changes all program amplitudes for the

active group at the same time.

Turning the neurostimulator ON or OFF

• Hold the programmer over the

neurostimulator and press the

NEUROSTIMULATOR ON or

OFF key.

Synchronizing the programmer

and neurostimulator

• Hold the programmer over the

neurostimulator and press the

SYNC key.

Side View

Status row

• Neurostimulator ON/OFF

• Implantable neurostimulator

battery level

• Programmer battery level

Group row

• Shows current group.

• Checkbox shows active group.

• Group Name is identied

by a letter (A-H).

• Options icon

appears only when

other groups are available.

Front View

Program number

• Shows program for group displayed.

OFF

Checking MyStim programmer

battery level

1. Synchronize the programmer and

neurostimulator .

2. Examine the programmer battery icon

in the top row.

Replace

batteries

New

batteries

Programmer battery level

Tips

• Always synchronize your programmer and neurostimulator at the beginning of a programming session

• Center the programmer within two inches of the neurostimulator when programming.

• The neurostimulator must be on to increase a parameter for an active group.

Audio alerts

One long beep

• Programming was successful.

Three short beeps

• Highest or lowest parameter limit reached,

• Programming was not successful

because:

– stimulation is turned o.

– programmer could not communicate

with the neurostimulator.

– changes are being made to an

inactive group.

Return to Clinician Settings

1. Verify the appropriate group is

active on the Group row.

2. Use the up

and down

NAVIGATOR keys to select the

Status row.

3. Use the left

and right

NAVIGATOR keys to select Return to

Clinician Settings.

4. Synchronize the programmer and

neurostimulator .

Changing a group

1. Synchronize the programmer

and neurostimulator.

2. Use the up

and down

NAVIGATOR

keys to select the Group row.

3. Use the left

and right

NAVIGATOR

keys to select a group.

4. Synchronize the programmer and

neurostimulator .

5. Verify that the group is active .

SYNC Key

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Related Manuals for Medtronic 97740

Summary of Contents for Medtronic 97740

Page 3: Label Symbols

Page 5: Table Of Contents

Page 11: English

Page 12: Glossary

Page 19: Introduction

Page 20: How To Use This Manual

Page 22: Patient Guides

Page 25: Patient Identification Card

Page 27: Important Therapy Information

Page 28: Purpose Of The Device

Page 29: Purpose Of The Neurostimulation System (Indications)

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

Page 35: Risks Of Surgery

Page 43: Precautions

Page 49: Individualization Of Treatment

Page 51: Recovery And Care After Surgery

Page 52: Recovery From Surgery

Page 54: When To Call Your Clinician

Page 56: Using Your Patient Programmer

Page 58: Patient Programmer Therapy Screen

Page 59: Status Row

Page 61: Group Row

Page 63: Parameter Row

Page 64: Patient Programmer Keys

Page 66: Using The Sync Key

Page 68: Using The Navigator Key

Page 70: Turning Your Neurostimulator On Or Off

Page 72: How To Maintain The Neurostimulator Batteries

Page 74: Checking The Implanted Rechargeable Neurostimulator Battery

Page 79: Checking The Implanted Nonrechargeable Neurostimulator Battery

Page 81: Changing Patient Programmer Preferences

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

Page 91: Using The Detachable Antenna

Page 96: Adjusting Your Stimulation

Page 99: Adjusting Stimulation Settings

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

Page 108: Changing Back To Clinician Settings

Page 111: Viewing And Changing A Group

Page 114: Displaying Group Names

Page 116: Using Groupadjust

Page 119: Viewing Scheduled Therapy

Page 121: Using Targetmystim

Page 124: Using Adaptivestim

Page 126: Adaptivestim Groups And Positions

Page 129: Turning Adaptivestim On And Off

Page 132: Making Adjustments To Adaptivestim

Page 135: Mri Examinations

Page 136: If You Have An Mri Appointment

Page 137: At The Mri Appointment

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

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

Page 141: Activating Mri Mode

Page 148: Turning Stimulation Back On After The Mri Scan

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

Page 155: Maintenance

Page 156: Patient Programmer Batteries

Page 159: Replacing The Patient Programmer Batteries

Page 161: Cleaning And Care

Page 162: Safety And Technical Checks

Page 163: Battery And Patient Programmer Disposal

Page 164: Specifications

Page 167: Troubleshooting

Page 168: Patient Programmer Screens

Page 172: Information Screens

Page 181: Communication Screens

Page 189: Additional Information

Page 190: How Stimulation Works

Page 195: Controlling Your Stimulation

Page 196: Possible Adverse Effects

Page 200: User Assistance

Page 201: Declaration Of Conformity

Page 203: Appendix A: Electromagnetic Interference (Emi)

Page 204: Contraindication

Page 220: Notes

Page 224: Index

Summary of Contents:

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