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NEUROMODULATION CONFIDENTIAL DOCUMENT/RECORD This document/record is electronically controlled, printed copies are considered uncontrolled. Identifier Version Author NDHF1245-121586 Title:
4.0 Monica Tuy 97745 User Manual DRAFT for Agency and Summative Testing Pages:
(including this page) Monica Tuy Signed By Responsibility Date/Time (GMT) APPROVALS Technical Communications Approver 7/12/2012 5:42:48 PM Form MEDN-0500 version 3.0 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 CONTROLLER Pain therapy user manual for Intellis Model 97715 and Model 97725 Wireless External Neurostimulation Systems 97745
! USA Rx only 2013 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Medtronic, AdaptiveStim, and SoftStart/Stop are trademarks of Medtronic, Inc., registered in the U.S. and other countries. Intellis is a trademark of Medtronic, Inc.
! USA FCC Information The following is communications regulation information on the Model 97745 Controller. FCC ID: LF597745 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 may cause undesired operation of the device. M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Label Symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. Conformit Europenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123) and R&TTE Directive 1999/5/EC. Consult instructions for use MR Magnetic Resonance (MR) Unsafe PIN No. EC REP
+XX C
+XXX F
-XX C
-XX F Manufacturer Serial number PIN number Authorized representative in the European community Temperature limitation Non-ionizing electromagnetic radiation IEC 60601-1/EN60601-1, Type BF Equipment 977452013-04English l s o b m y S l e b a L 3 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 System meets the applicable Canadian
(CAN/CSA-C22.2 No. 60601-1) and US
(UL 60601-1:2003) electrical safety standard requirements. Chinese Standard (SJ/T11364-2006) Logo: Electronic Information Products Pollution Control Symbol. (The date in this logo means the environmental protection use period of the product.) 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 l s o b m y S l e b a L 4 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table of contents Label Symbols 3 Glossary 12 1Introduction 20 How to use this manual 20 Patient guides 22 Patient identification card 25 2Important therapy information 28 Purpose of the device 28 Purpose of the neurostimulation system
(indications) 28 Description of your system 29 Therapies that may not be used with the neurostimulation system
(contraindications) 33 Risks and benefits 33 Risks of surgery 34 Warnings 34 Precautions 43 t s t n e n o c f o 977452013-04English l e b a T 5 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Individualization of Treatment 48 3Recovery and care after surgery 52 Recovery from surgery 52 Activities 52 When to call your clinician 54 Care schedule 55 4Using your controller 58 How your controller works 58 Controller screen and keys 59 Home screen 62 Unlocking and locking your controller 65 Unlocking your controller 65 Locking your controller 69 Turning your stimulation on or off 70 Turning your stimulation on for all pain areas 70 Turning your stimulation off for all pain areas 72 How to maintain neurostimulator batteries 75 English97745 t s t n e n o c f o l e b a T 6 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Checking the battery status of the controller and neurostimulator 75 Changing controller preferences using the Menu 80 To access the Menu screen 80 Changing the audio and vibration settings 84 Changing the brightness of the controller display 86 Changing the date 87 Changing the time 88 Changing the language 90 Changing the number format 91 Viewing information about the controller and the neurostimulator 92 5Adjusting your stimulation 96 Introduction 96 Stimulation features 96 Adjusting stimulation settings 96 Programming modes 100 Changing parameter and stimulation settings 101 Increasing or decreasing a parameter
(intensity, pulse width, or rate) 106 977452013-04English M948515A001Rev X2013-04 t s t n e n o c f o l e b a T 7 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Adjusting intensity for all pain areas together 108 Turning stimulation on or off for individual pain areas 110 Turning cycling on or off 112 Changing a program for individual pain areas 114 Viewing and changing a group 115 Using AdaptiveStim 117 AdaptiveStim groups and positions 119 Checking your body position 121 Turning AdaptiveStim on or off 124 Making adjustments to AdaptiveStim 125 6MRI examinations 128 If you have an MRI appointment 128 Responsibilities of the patient in preparing for the MRI appointment 129 At the MRI appointment 130 Determining if you are in MRI mode 131 Placing your neurostimulation system in MRI mode for the MRI scan 133 Using your controller to activate MRI mode 134 Activating MRI mode 135 English97745 t s t n e n o c f o l e b a T 8 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Turning stimulation back on after the MRI scan 139 Visiting your clinician to activate MRI mode 141 7Using the recharging system with the implanted neurostimulator 146 Recharging the implanted neurostimulator battery 146 Recharging the neurostimulator battery 146 To stop recharging the neurostimulator battery 154 Changing the recharging temperature and speed 155 Recharging the controller battery pack 158 8Troubleshooting 164 Controller screens 164 Warning screens 165 Alert screens 173 Notification screens 182 977452013-04English M948515A001Rev X2013-04 t s t n e n o c f o l e b a T 9 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Possible problems and solutions 187 9Additional information 194 How stimulation works 194 Controlling your stimulation 199 What your clinician controls 199 What you control 199 Possible adverse effects 200 Changes in therapy 200 Possible system complications 200 10Maintenance and assistance 204 Accessories 204 Labeling the controller 204 Using the carrying case 205 Replacing the type AA controller batteries 206 Replacing the controller battery pack 207 Setting up a new controller 208 Cleaning and care 219 Safety and technical checks 221 Battery and controller disposal 221 Neurostimulator disposal 221 t s t n e n o c f o l e b a T 10 English97745 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Specifications 222 User assistance 223 Declaration of conformity 224 11Appendix A: Electromagnetic interference (EMI) 226 Contraindication 226 Warnings 227 Precautions 238 Notes 242 Index 244 t s t n e n o c f o 977452013-04English l e b a T 11 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 instructions to a neurostimulator. Contraindication - A condition or circumstance when a person should not have a neurostimulation system. Controller - A hand-held device that allows you to turn your neurostimulator on and off and check your neurostimulator battery. It is also used to adjust some of the stimulation settings. y r a s s o G l 12 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 not produce heat within the body. This treatment is typically used to relieve pain, stiffness and muscle spasms, reduce joint contractures, reduce swelling and pain after surgery, and promote wound healing. Discharged battery - The rechargeable battery is depleted and should be charged as soon as possible. When the battery is in a discharged state, therapy is not available. Elective replacement indicator (ERI) -
Notification that the INS is nearing or has reached its recommended replacement date. Electrode - A metal piece near the tip of the lead. Electrodes deliver electrical pulses to the area where your pain signals will be blocked. 977452013-04English y r a s s o G l 13 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Electromagnetic interference (EMI) - A strong field of energy near electrical or magnetic devices that could prevent the neurostimulator from functioning properly. End of service (EOS) - Condition of an ENS at the time it is no longer able to operate successfully. External neurostimulator (ENS) - See Neurostimulator. Group - Collection of programs that work together for a particular effect or area. Implanted neurostimulator (INS) - See Neurostimulator. Indication - The purpose of the neurostimulation system and the medical condition for which it may be implanted. Intensity - The strength of an electrical pulse. y r a s s o G l 14 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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. 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 whether or not stimulation is effective. An implanted neurostimulator is placed inside the body. If stimulation is effective during test stimulation, the neurostimulator is implanted. Out-of-regulation (OOR) - The neurostimulator battery is unable to produce the levels of energy required for the current stimulation settings. Pain areas - An area of the body where a patient feels pain. 977452013-04English M948515A001Rev X2013-04 y r a s s o G l 15 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Parameter - One of three stimulation settings that adjust the electrical pulse: intensity, pulse width, and rate. Precaution - See Caution. Program - Stimulation directed to a specific pain site. Pulse width - The length or duration of an electrical pulse. Recharger - The component of the neurostimulation system that is used to recharge your neurostimulator battery. SoftStart/Stop - This feature is programmed by your clinician. When the neurostimulator is turned on, stimulation will slowly increase to the programmed intensity. When the neurostimulator is turned off, stimulation will slowly decrease. 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. English977452013-04 y r a s s o G l 16 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 the stimulation you feel. The clinician programs all stimulation. You can adjust some stimulation settings within clinician-defined limits. Test stimulation - The period of time when an external neurostimulator is used to determine if stimulation blocks the pain signals effectively. 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. y r a s s o G l 17 977452013-04English M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Therapy settings - A specific combination of intensity, rate, and pulse width parameters used to control the stimulation delivered by a neurostimulator. Warning - A statement describing an action or situation that could harm the patient. y r a s s o G l 18 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 1Introduction M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 provided at the beginning of this manual. Chapter 1 "Introduction", describes how to use this manual, patient guides you should receive, and information about the patient identification card. Chapter 2 "Important therapy information", describes when you should and should not use a neurostimulation system, the neurostimulation system components, and the risks, benefits, warnings, precautions, and patient activities related to your neurostimulation system. Chapter 3 "Recovery and care after surgery", provides information about recovering from surgery, activity and care English977452013-04 1 n o i t c u d o r t n I 20 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 information, and when to contact your clinician. Chapter 4 "Using your controller", describes the controller and how to perform specific tasks. Chapter 5 "Adjusting your stimulation", describes how to adjust your stimulation using your controller. Chapter 6 "MRI examinations", provides important information about what you should do if you have an MRI examination. Chapter 7 "Using the recharging system with the implanted neurostimulator", describes how to use the recharging system to recharge your implanted neurostimulator battery. Chapter 8 "Troubleshooting", describes controller warning, alert, and information screens and how to solve problems. Chapter 9 "Additional information", describes how stimulation works, possible 977452013-04English M948515A001Rev X2013-04 1 n o i t c u d o r t n I 21 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 adverse effects, changes in therapy, and possible system complications. Chapter 10 "Maintenance and assistance", describes how to set up a new controller, care for your controller, and instructions on using accessories. This chapter also provides controller specifications and information about who to call for assistance. Chapter 11 "Appendix A: Electromagnetic interference (EMI)", provides information about electromagnetic interference and how it may affect your neurostimulation system. Patient guides Table 1.1 on page 23 describes the documents you should receive during test stimulation and after a neurostimulator is implanted. English977452013-04 1 n o i t c u d o r t n I 22 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 1.1Patient guides for test stimulation and implanted neurostimulation systems ENSa X INSb X X Document Medtronic Model 97725 Wireless External Neurostimulator:
Test Stimulation Patient Guide Describes the goals, activities, components, and instructions for test stimulation. Medtronic Model 97745 Controller:
Quick Reference Guide: Provides instructions for common controller tasks. 1 n o i t c u d o r t n I 23 977452013-04English M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 1.1Patient guides for test stimulation and implanted neurostimulation systems
(continued) INSb X X ENSa Document Medtronic Model 97755 Recharger:
Recharging System User Manual:
Describes the components of the recharging system, including the rechargeable battery pack and power supply. Patient Identification Card: Provides information about you, your implanted neurostimulator, and your doctor. a External neurostimulator b Implanted neurostimulator English977452013-04 1 n o i t c u d o r t n I 24 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 security devices. Carry this card with you at all times and bring this card with you to all 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.
! USA A temporary identification card will be provided at the hospital. After Medtronic receives your implant registration from the hospital, you will receive a permanent identification card. 1 n o i t c u d o r t n I 25 977452013-04English M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 1 n o i t c u d o r t n I 26 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 2Important therapy information M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Purpose of the device The Medtronic Model 97745 Controller is designed to program the following Medtronic neurostimulators:
Rechargeable Intellis Model 97715 Implanted Neurostimulator Nonrechargeable Model 97725 Wireless External Neurostimulator Refer to your patient identification card to determine the model number of your neurostimulator. Purpose of the neurostimulation system
(indications) Refer to the indications sheet that is packaged with the controller for the purpose of the neurostimulation system and related information. 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 28 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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):
a neurostimulator, 1 or more leads, and 1 or more extensions (optional). 2 n o i t a m r o n f i y p a r e h t t n a t r o p m 977452013-04English I 29 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Neurostimulator Extensions Leads Electrodes Figure 2.1Implanted parts of a typical neurostimulation system (spinal cord stimulation shown). A typical neurostimulation system also includes an external controller for controlling your system. If you have a rechargeable neurostimulator, your system also includes a recharging system (Figure 2.2). 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 30 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Recharging system
(packaged separately) Recharger Belt Power Supply Controller Battery pack Figure 2.2Recharging components of a rechargeable 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 an implanted neurostimulator is the right choice for you. 2 n o i t a m r o n f i y p a r e h t t n a t r o p m 977452013-04English I 31 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Note: Your controller refers to the neurostimulator as the device. 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 electrical pulses to the area where your pain signals are blocked. Extension(s) An extension is a set of thin wires, covered with a protective coating, that connects the neurostimulator to a lead. Not all neurostimulation systems include an extension. Controller A controller is a hand-held device that you use to select and adjust your stimulation. Recharging system The recharging system is used to charge the implanted rechargeable neurostimulator battery. Components included in the recharging system are: recharger, belt, battery pack, power supply, and system carrying case. Refer to the manual packaged with the recharging system for more 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 32 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 information about the recharging system components. Therapies that may not be used with the neurostimulation system
(contraindications) DiathermyInform anyone treating you that you CANNOT have any shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) anywhere on your body because you have an implanted neurostimulation system. Energy from diathermy can be transferred through your implanted system, and can cause tissue damage, resulting in severe injury or death. 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 2 n o i t a m r o n f i y p a r e h t t n a t r o p m 977452013-04English I 33 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 fluid leak, headaches, swelling, bruising, bleeding, infection, or paralysis. If you are on anticoagulation therapy you might be at greater risk for postoperative complications such as hematomas that could result in paralysis. For information about possible adverse effects, refer to "Possible adverse effects" on page 200. Warnings Wound contactDO NOT use the recharger on an unhealed wound. The recharging system is not sterile, and contact with the wound may cause an infection. 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 34 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Trial systems (neurostimulation systems that are not fully implanted)MRI should not be prescribed for patients undergoing trial
(test) stimulation or who have any neurostimulation system components that are not fully implanted. If an MRI scan is required, the clinician must explant all trial (test) stimulation components. MRI has not been tested on trial (test) stimulation components and may cause heating of the lead electrodes, resulting in tissue damage or serious patient injury. Electromagnetic interference 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 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:
2 n o i t a m r o n f i y p a r e h t t n a t r o p m 977452013-04English I 35 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Serious patient injury or death, resulting from heating of the implanted components of the neurostimulation system and damage to surrounding tissue. System damage, resulting in a loss of or change in symptom control and requiring additional surgery. Operational changes to the neurostimulator, that can cause it to turn on or off, resulting in loss of neurostimulation and the return of underlying symptoms. Unexpected changes in stimulation, causing a momentary increase in 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 cases, as a result of the unexpected change in stimulation, patients have fallen down and been injured. 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 36 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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. 2 n o i t a m r o n f i y p a r e h t t n a t r o p m 977452013-04English I 37 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 s e r u d e c o r p r o s e c i v e d m o r f I M E f o s t c e f f e l a i t n e t o P 1
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e d y t i r u c e s r o e c v i 977452013-04English M948515A001Rev X2013-04 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 41 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Case damageIf 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 devicesWhen a neurostimulator and an implanted cardiac device (eg, pacemaker, defibrillator) are required, the doctors involved with both devices (eg, neurologist, neurosurgeon, cardiologist, cardiac surgeon) should discuss the possible interactions between the devices before surgery. To minimize or prevent device damage or interactions, your doctors should place the devices on the opposite side of the body from one another. Defibrillation therapy from an implanted defibrillator can damage the neurostimulator. The electrical pulses from the neurostimulation system could affect with the sensing operation from the cardiac device and result in inappropriate responses from the cardiac device.Your English977452013-04 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 42 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 doctor should 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 Battery charge levelCheck battery status and charge the battery regularly. Battery capacity will continue to slowly drain, even when the neurostimulator is off. If the battery becomes completely discharged, therapy will be lost. Clinician programmer interaction with a cochlear implantIf you have a cochlear implant, the external portion of the cochlear system should be kept as far away as possible from the clinician programmer or the cochlear implant should be turned off during programming to prevent unintended audible clicks. 2 n o i t a m r o n f i y p a r e h t t n a t r o p m 977452013-04English I 43 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Component compatibilityFor proper therapy, use only Medtronic Neuromodulation components that are prescribed by your physician. Equipment modificationDo not modify this equipment. Modification of this equipment can result in damage to the device, causing the device to malfunction or become unusable. Patient control devices may affect other implanted devicesDo not place patient control devices (eg, patient programmer, controller, recharger) over another device (eg, pacemaker, defribrillator, another neurostimulator). The patient control device could accidently change the operation of another device. Patient device handlingTo avoid damaging the device, do not immerse it in liquid; do not clean it with bleach, nail polish remover, mineral oil, or similar substances;
and do not drop it or mishandle it in a way that may damage it. 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 44 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Patient device useWhen operating a patient control device (eg, external neurostimulator, patient programmer, controller, recharging system), use special care near flammable or explosive atmospheres. An interaction between the flammable or explosive atmospheres and the battery in the device could occur. The consequences of using a battery-powered device near flammable or explosive atmospheres are unknown. Programmer interaction with other active implanted devicesIf you have a neurostimulator and another active implanted device the radio-frequency (RF) signal used to program either device can reset or reprogram the other device. To verify that inadvertent programming did not occur, clinicians familiar with each device should check the programmed settings before you are sent home from the hospital and after either device is programmed (or as soon as possible after these times). 2 n o i t a m r o n f i y p a r e h t t n a t r o p m 977452013-04English I 45 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Contact your doctor immediately if you notice symptoms that could be related to either device or to the medical condition treated by either device. Patient activities Activities requiring excessive twisting or stretchingAvoid activities that may put undue stress on the implanted components of your neurostimulation system. 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 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 (twiddlers syndrome)Do not manipulate or rub your neurostimulation system through the skin; this is sometimes called twiddler's syndrome. Manipulation can cause damage to your 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 46 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 system, lead dislodgement, skin erosion, or stimulation at the implant site. Scuba diving or hyperbaric chambersDo not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 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. Skydiving, skiing, or hiking in the mountainsHigh 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. During skydiving, the sudden jerking that occurs when the parachute opens can dislodge or fracture the lead, requiring additional surgery to repair or replace the lead. Unexpected changes in stimulation Electromagnetic interference, changes in 977452013-04English M948515A001Rev X2013-04 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 47 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 posture, and other activities can cause a perceived increase in stimulation, which some patients have described as uncomfortable stimulation (a jolting or shocking sensation). You should reduce your intensity to the lowest setting and turn off your neurostimulator before engaging in activities that could be unsafe for you or others if you received an unexpected jolt or shock (eg, driving, operating power tools). Discuss these activities with your doctor. Individualization of Treatment Patient managementBest 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 neurostimulation system require long-term postsurgical management. Patient selectionThe neurostimulation system should not be implanted if:
your symptoms are not of physiological origin, 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 48 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 you are not an appropriate candidate for surgery, you cannot properly operate the system, or you do not receive satisfactory results from test stimulation. Use in specific populationsThe safety and effectiveness of this therapy has not been established for the following:
Pregnancy, unborn fetus, or delivery Pediatric use (patients under the age of 18) 2 n o i t a m r o n f i y p a r e h t t n a t r o p m 977452013-04English I 49 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 2 n o i t a m r o n f i y p a r e h t t n a t r o p m I 50 English977452013-04 M948515A001Rev X2013-04
1 2 | User Manual part 2 of 6 | Users Manual | 5.43 MiB |
Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 3Recovery and care after surgery M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 help manage your pain. Always follow your doctors instructions. wWarning: DO NOT use the recharger on an unhealed wound. The recharging system is not sterile, and contact with the wound can cause an infection. Activities Some movements can cause changes in stimulation. For example, leaning back may cause the lead to move closer to your spinal cord; this can increase the sensation of stimulation. Other movements may cause the lead to move further away from your spinal cord and decrease the stimulation sensation. Sudden 3 y r e g r u s r e t f a e r a c d n a y r e v o c e R 52 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 changes in stimulation are most common while you are recovering from surgery. Avoid activities where you must bend, stretch, or twist your body; these movements can move your leads, which affects your stimulation. 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 should be able to perform activities such as:
Bathing or showering Sexual activity Working at home or at your business Hobbies or activities, such as walking, gardening, cycling, or swimming 3 y r e g r u s r e t f a e r a c d n a y r e v o c e R 977452013-04English 53 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 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 discomfort or pain during stimulation. Turn your stimulation off and call your clinician. Your system is not working properly. You cannot turn stimulation on or off. You cannot adjust stimulation using your controller. 3 y r e g r u s r e t f a e r a c d n a y r e v o c e R 54 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Care schedule Your clinician will schedule follow-up visits to make sure you are receiving the most appropriate therapy. 3 y r e g r u s r e t f a e r a c d n a y r e v o c e R 977452013-04English 55 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 3 y r e g r u s r e t f a e r a c d n a y r e v o c e R 56 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 4Using your controller M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 How your controller works The controller communicates wirelessly with your neurostimulator by sending signals to and receiving signals from the neurostimulator. Your neurostimulator only accepts communications from the controller or clinician programmer. Sending information from the neurostimulator to the controller will only occur after the controller and neurostimulator are
"paired". Your neurostimulator will not be able to send information to anything except for the controller that it is paired with. Your doctor will pair your controller and neurostimulator. If you receive a new controller or for some other reason it is not paired with your neurostimulator, see "Setting up a new controller" on page 208, for information about how to pair the controller and the neurostimulator. Note: Make sure to keep your controller with you at all times in the event that you need to adjust or turn your stimulation off. Use the controller to:
4 r e l l o r t n o c r u o y i g n s U 58 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Turn your stimulation on or off. Check the neurostimulator and controller battery status. Change stimulation settings. Notes:
The controller 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 is referenced to determine if the information is applicable for your neurostimulator. The controller is an electronic device that should be used in accordance with any restrictions while traveling (eg, airplane takeoffs). Controller screen and keys Your controller has a touchscreen, a display screen that reacts to your touch and allows you to press buttons and functions that are displayed on the screen. Use one finger when 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 59 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 pressing buttons or functions. Having multiple fingers at once on the front face of the controller may not allow the function or task to be performed. There are 3 different ways to use the touchscreen depending on the function or task:
Short, light presses for a button selection. Pressing and holding to unlock a screen. Pressing lightly and dragging a slider bar to view additional selections. In addition to these on-screen buttons and functions, your controller also has a number of keys (Table 4.1). Table 4.1Controller keys Function Turns stimulation on or off. Key Stimulation On/Off 4 r e l l o r t n o c r u o y i g n s U 60 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 4.1Controller keys (continued) Key Increase/
Decrease Function Adjust stimulation. Select and navigate settings displayed on the screen. Wake up the controller. Note: To perform most functions on the controller, you must first press the Increase/Decrease key to wake up the controller. There is a charging port on the bottom of the controller and a recharging light above the touchscreen. The charging port and recharging light are used with rechargeable neurostimulators (Figure 4.1). 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 61 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Stimulation On/Off key Recharging light Touchscreen Increase key Decrease key Charging port Figure 4.1Controller keys. Home screen The Home screen is the first screen to appear after unlocking your controller. The Home screen provides an overview of your stimulation settings (Figure 4.2). Note: The Home screen may look different for each patient depending on which mode your clinician has programmed for your neurostimulator. The modes are: Single and Group mode. 4 r e l l o r t n o c r u o y i g n s U 62 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Details about what is displayed on the Single and Group mode Home screens are provided in "Programming modes" on page 100. Battery status button Lock button Pain area stimulation on/off buttons Menu button Pain area buttons Figure 4.2Home screen (Single mode shown). The number of Pain areas displayed on the Home screen depends on how your clinician has programmed your neurostimulator. There can be up to 4 pain areas. The buttons at the top of the Home screen allow you to perform the following tasks:
Check the battery status of the controller. Check the battery status of the neurostimulator. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 63 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Lock the controller. Access the Menu screen. Refer to Table 4.2 for more information on these buttons. Icon Table 4.2Home screen buttons Description Battery status button The left icon on this button displays the controller battery status. The right icon on this button displays the neurostimulator battery status. Press this button to check the battery status in detail. For more information on checking batteries, see "Checking the battery status of the controller and neurostimulator" on page 75. Lock button Press this button to lock the controller. 4 r e l l o r t n o c r u o y i g n s U 64 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 4.2Home screen buttons (continued) Icon Description Menu button Press this button to access the Menu screen. For more information about the Menu screen options. Refer to
"Changing controller preferences using the Menu"
on page 80. Unlocking and locking your controller Unlocking your controller When the Increase/Decrease key is pressed to wake up the controller, the Unlock screen appears (Figure 4.3). 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 65 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Figure 4.3Unlock screen. Notes:
If the controller does not display the Unlock screen, the controller may not have been properly set up. Call your clinician if the Unlock screen does not appear. When the controller is locked, pressing the Stimulation On/Off key will provide the option to bypass the Unlock screen and to turn stimulation on or off. 1. Press and hold the Lock (
) button on the Unlock screen. 4 r e l l o r t n o c r u o y i g n s U 66 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 As the Lock button is held, bars appear on the screen and move toward the Lock button (Figure 4.4). Figure 4.4Unlocking the controller. 2. Stop pressing the Lock button when the screen changes to a circle of dots
(Figure 4.5). The controller is searching for your neurostimulator. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 67 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Figure 4.5The controller searching for your neurostimulator. After unlocking the controller, the first screen you see is the Home screen
(Figure 4.6). 4 r e l l o r t n o c r u o y i g n s U 68 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Single mode Group mode Figure 4.6Home screen. If the Home screen does not appear, see
"Troubleshooting" on page 163. Locking your controller Your controller can be locked, so if buttons or keys are accidentally pressed, there will not be an unexpected change in your stimulation. If you have stimulation on, locking your controller will not turn stimulation off. Stimulation will remain on even when the controller is locked. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 69 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Note: The controller screen will dim after 30 seconds of inactivity, and will automatically lock itself after 2 minutes of inactivity. You can also press the Lock button to lock the controller immediately. 1. From the Home screen, press the Lock
(
) button to lock the controller. Turning your stimulation on or off You can turn stimulation on or off at any time. Follow these steps to turn your stimulation on or off for all pain areas. To turn stimulation on or off for individual pain areas, refer to "Turning stimulation on or off for individual pain areas" on page 110. Turning your stimulation on for all pain areas 1. To turn stimulation on, firmly press the Stimulation On/Off key, which is located on the top of your controller. 4 r e l l o r t n o c r u o y i g n s U 70 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 2. Press the Stimulation On button to turn stimulation on (Figure 4.7). Note: If you do not wish to turn stimulation on or off, but want to access the Home screen, press the Go To Unlock button and unlock your controller. Figure 4.7Turning stimulation on. 3. The Home screen will appear to confirm that stimulation is on (Figure 4.8). Single mode: The Pain area stimulation on/off buttons will display checkmarks highlighted in green when stimulation is turned on. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 71 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Group mode: The Group button will be highlighted in green when stimulation is turned on. Single mode Group mode Figure 4.8Home screen with stimulation turned on. Turning your stimulation off for all pain areas 1. To turn stimulation off, firmly press the Stimulation On/Off key, which is located on the top of your controller. 4 r e l l o r t n o c r u o y i g n s U 72 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 2. Press the Stimulation Off button to turn stimulation off (Figure 4.9). Notes:
If you do not wish to turn stimulation off, but instead wish to access the Home screen, press the Go To Unlock button. If your controller was already on, instead of the Go To Unlock button, the Lock Controller button will be shown. 4 r e l l o r t Figure 4.9Turning stimulation off. 3. The Home screen will appear to confirm that stimulation is off (Figure 4.10). n o c r u o y i g n s U 977452013-04English 73 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Single mode: The Pain area stimulation on/off buttons will display gray dashes when stimulation is turned off. An orange message will also be shown that reads "Stimulation is off". Group mode: The Group button will be shown in gray when stimulation is turned off. An orange message will also be shown that reads "Stimulation is off". Single Mode Group Mode Figure 4.10Home screen with stimulation turned off. 4 r e l l o r t n o c r u o y i g n s U 74 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 How to maintain neurostimulator batteries It is very important that you maintain your neurostimulator batteries, whether you have an external or an implanted rechargeable neurostimulator.
#Caution: Check battery status and charge the battery regularly. Battery capacity will continue to slowly drain, even when the neurostimulator is off. If the battery becomes completely discharged, therapy will be lost. Though you will not need to recharge the external neurostimulator, you should check the battery status regularly and report any low battery messages to your clinician. Checking the battery status of the controller and neurostimulator Check the status of the batteries in your controller and your neurostimulator every day. You can check the status of the batteries at any time. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 75 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Note: The battery levels of the controller and the neurostimulator are shown on the Battery
) button on the Home screen. For status (
further detail about battery levels, follow the steps below. 1. If necessary, unlock the controller by pressing and holding down the Lock (
button on the Unlock screen.
) 2. From the Home screen, press the Battery
) button. Two battery figures status (
appear (Figure 4.11). Controller battery status Neurostimulator (device) battery status 4 r e l l o r t n o c r u o y i g n s U Figure 4.11Batteries screen. 3. Press the Exit (
) button at the top right corner of the touchscreen to exit. 76 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 4.3 lists the different battery indicators. Table 4.3Battery indicators Description Indicator icon Controller battery. Neurostimulator (device) battery:
External neurostimulator. Implanted neurostimulator. Table 4.4 lists several battery level definitions and whether action is needed. Table 4.4Battery level definitions Battery icon Definitions Battery icon is green. Battery level is full. No action is needed. Battery icon is green. Battery level is half full. No action is needed. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 77 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 4.4Battery level definitions (continued) Battery icon Definitions Battery icon is orange. Battery level is low. Action is needed soon. If you have an external neurostimulator. Replace the controller batteries soon. See
"Replacing the type AA controller batteries"
on page 206. If you have an implanted neurostimulator:
Recharge the controller battery pack. See "Recharging the controller battery pack" on page 158. Recharge the neurostimulator battery. See "Recharging the implanted neurostimulator battery" on page 146. 4 r e l l o r t n o c r u o y i g n s U 78 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 4.4Battery level definitions (continued) Battery icon Definitions Battery icon is red. Battery level is nearly depleted. Action is needed now. If you have an external neurostimulator:
Replace the controller batteries. See
"Replacing the type AA controller batteries" on page 206. Stimulation may not be available, the external neurostimulator batteries will need to be replaced. Do not replace the external neurostimulator batteries by yourself. Call your clinician. If you have an implanted neurostimulator:
Recharge the controller battery pack. See "Recharging the controller battery pack" on page 158. Stimulation may not be available. Recharge the neurostimulator battery. See "Recharging the implanted neurostimulator battery" on page 146.
"Controller screens" on page 164 lists the warning and alert screens associated with the 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 79 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 batteries for the controller and neurostimulators. Changing controller preferences using the Menu Controller preferences affect the way information displays on the screen or the way alert/vibration tones sound or are felt. These controller preferences include audio/vibration, brightness, date, time, language, and number format. Other features can also be accessed from Menu screen. Table 4.5 on page 81 lists the preferences associated with the Menu screen and where to find information for other features. To access the Menu screen 1. Press the Menu (
) button on the Home screen. 2. Drag the slider bar, or use the Increase/
Decrease key to view other preferences on the Menu screen (Figure 4.12). 4 r e l l o r t n o c r u o y i g n s U 80 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Exit button Slider bar Figure 4.12Menu screen. 3. Select the Menu preference. Refer to Table 4.5 for preferences and instructions. Table 4.5Controller preferences on the Menu screen Menu preference Audio/Vibe Description This option is used to adjust the audio and vibration settings. Refer to "Changing the audio and vibration settings" on page 84. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 81 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 4.5Controller preferences on the Menu Menu preference Check Position MRI Mode Brightness Date 4 r e l l o r t n o c r u o y i g n s U screen (continued) Description This feature is only used with the implanted neurostimulator. It is used to check your current body position if your physician has enabled the AdaptiveStim feature. Refer to "Checking your body position"
on page 121. This feature is only used with the implanted neurostimulator. It is used to turn stimulation off to prepare for an MRI examination. Refer to "Placing your neurostimulation system in MRI mode for the MRI scan"
on page 133. This option is used to adjust the brightness of the touchscreen. Refer to "Changing the brightness of the controller display" on page 86. This option is used to change the date displayed on your controller. Refer to "Changing the date" on page 87. 82 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 4.5Controller preferences on the Menu Menu preference Time Language Numbers About screen (continued) Description This option is used to change the time and format displayed on the controller. Refer to "Changing the time" on page 88. This option is used to change the language displayed on the controller. Refer to "Changing the language" on page 90. This option is used to change how numbers are displayed on the controller. Refer to "Changing the number format"
on page 91. This option is used to review technical information about your neurostimulation system. Refer to "Viewing information about the controller and the neurostimulator" on page 92. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 83 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 4.5Controller preferences on the Menu Menu preference Recharging screen (continued) Description This feature is only used with the implanted neurostimulator. It is used to change the battery recharging speed and temperature while recharging. Refer to "Changing the recharging temperature and speed" on page 155. Changing the audio and vibration settings The controller will play an audio tone to alert you of any problems during recharging of the implanted neurostimulator. The Audio option can be set to off, low, or high. The controller will vibrate every time you press a key or screen button to confirm your press. The Vibration option can be set to off or on. 4 r e l l o r t n o c r u o y i g n s U 84 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 1. Select the Audio/Vibe button from the Menu screen. The Audio/Vibe screen appears (Figure 4.13). Off Off Low High On Figure 4.13Audio/Vibe screen. 2. To change audio settings, press the desired button for Audio Off, Low, or High. 3. To change vibration settings, press the desired button for Vibration Off or On. 4. Press the OK button to return to the Menu screen. 5. Press the Exit (
Home screen.
) button to return to the 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 85 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Changing the brightness of the controller display 1. Select the Brightness button from the Menu screen. The Brightness screen appears (Figure 4.14). Figure 4.14Brightness screen. 2. Using the touchscreen or the Increase/
Decrease key, select the circle below the desired brightness level. 3. Press the OK button to return to the Menu screen. 4. Press the Exit (
Home screen.
) button to return to the 4 r e l l o r t n o c r u o y i g n s U 86 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Changing the date Note: Date settings cannot be changed while recharging the implanted neurostimulator. 1. Drag the slider bar, or use the Increase/
Decrease key to view additional preferences on the Menu screen. 2. Select the Date button from the Menu screen. The Date screen appears
(Figure 4.15). Day Month Year Figure 4.15Date screen. 3. To change the Day, Month, or Year, press the touchscreen button with the incorrect value, then use the Increase/Decrease key to change the value. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 87 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 4. Press the OK button to return to the Menu screen. 5. Press the Exit (
Home screen.
) button to return to the Changing the time Note: Time settings cannot be changed while recharging the implanted neurostimulator. 1. Drag the slider bar, or use the Increase/
Decrease key to view additional preferences on the Menu screen. 2. Select the Time button from the Menu screen. The Time screen appears
(Figure 4.16). 4 r e l l o r t n o c r u o y i g n s U 88 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Hour Minute Time format Figure 4.16Time screen. 3. To change the Hour, Minute, or Time format, press the touchscreen button with the incorrect value or format, then use the Increase/Decrease key to change the value or format. Note: Time format selections include: AM/
PM and 24-hour. 4. Press the OK button to return to the Menu screen. 5. Press the Exit (
Home screen.
) button to return to the 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 89 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Changing the language 1. Drag the slider bar, or use the Increase/
Decrease key to view additional preferences on the Menu screen. 2. Select the Language button from the Menu screen. The Language screen appears
(Figure 4.17). Slider bar Figure 4.17Language screen. 3. Select the desired language from the options available. Drag the slider bar, or use the Increase/Decrease key to view more language options. 4 r e l l o r t n o c r u o y i g n s U 90 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 4. Press the OK button to return to the Menu screen. 5. Press the Exit (
Home screen.
) button to return to the Changing the number format 1. Drag the slider bar, or use the Increase/
Decrease key to view additional preferences on the Menu screen. 2. Select the Numbers button from the Menu screen. The Numbers screen appears
(Figure 4.18). 4 r e l l o r t Figure 4.18Numbers screen. n o c r u o y i g n s U 977452013-04English 91 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 3. Using the touchscreen or the Increase/
Decrease key, select the circle next to the desired number format for the controller. 4. Press the OK button to return to the Menu screen. 5. Press the Exit (
Home screen.
) button to return to the Viewing information about the controller and the neurostimulator 1. Drag the slider bar, or use the Increase/
Decrease key to view additional preferences on the Menu screen. 2. Select the About button from the Menu screen. The About screen appears
(Figure 4.19). 4 r e l l o r t n o c r u o y i g n s U 92 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Left button Right button Figure 4.19About screen. 3. Use the Left/Right button or Increase/
Decrease key to view information about the controller and neurostimulator. Note: The following information may be available through the About screen. Information shown may be different depending on the type of neurostimulator that is paired with the controller. ERI (Elective Replacement Indicator): The estimated date that the implanted neurostimulator may be replaced. 4 r e l l o r t n o c r u o y i g n s U 977452013-04English 93 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 INS (Implanted Neurostimulator):
The model number, serial number, and system information for the implanted neurostimulator. ENS (External Neurostimulator): The model number, serial number, and system information for the external neurostimulator.
! (Last Error): The date that the last warning or alert screen was displayed on the controller. PTM (Controller): The software version that your controller is using. This screen may also show the recharger compatibility for the implanted neurostimulator. 4. Press the OK button to return to the Menu screen. 5. Press the Exit (
Home screen.
) button to return to the 4 r e l l o r t n o c r u o y i g n s U 94 English977452013-04 M948515A001Rev X2013-04
1 2 | User Manual part 3 of 6 | Users Manual | 3.52 MiB |
Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 5Adjusting your stimulation M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 intensity, pulse width, and rate settings for your stimulation. For complete information, see "Changing parameter and stimulation settings" on page 101. For information about Single and Group mode, refer to "Programming modes" on page 100. For information about AdaptiveStim, refer to
"Using AdaptiveStim" on page 117. Adjusting stimulation settings As your activities vary throughout the day, your therapy needs may change. The controller allows you to turn stimulation on and off, switch from one programmed stimulation option to 5 n o i t l a u m i t s r u o y g n i t s u d A j 96 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 another, and adjust the intensity, pulse width, and rate of the stimulation. 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 controller. Discuss this with your clinician. There is often more than one way to change stimulation settings. These instructions describe the most common ways. Note: When a stimulation setting is changed, you will see the change when accessing a Pain area through the Home screen. 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. Table 5.1 provides general guidelines for adjusting your stimulation. For additional adjustment guidelines, refer to the sections on 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 97 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 the specific features associated with your neurostimulator. Table 5.1General stimulation adjustment Situation Stimulation is too strong Stimulation is not strong enough Stimulation covers too much area Stimulation does not cover painful area The pulses (tapping sensations) feel too slow The pulses (tapping sensations) feel too fast guidelines Action Decrease intensities or pulse width(s). Increase intensities or pulse width(s). Decrease intensities or pulse width(s) or change to a different program or group. Increase intensities or pulse width(s) or change to a different program or group. Increase rate. Decrease rate. 5 n o i t l a u m i t s r u o y g n i t s u d A j 98 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 5.1General stimulation adjustment guidelines (continued) Situation You have unexpected changes in stimulation Action 1. Turn off the neurostimulator. 2. Decrease intensities, turn on the neurostimulator, adjust parameters, and slowly increase intensities to the desired level. or Change to a different program or group and turn on the neurostimulator. Contact your clinician. You have tried adjusting stimulation but are unable to find an effective setting. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 99 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 5.1General stimulation adjustment guidelines (continued) Action Before engaging in these activities, consult "Appendix A: Electromagnetic interference (EMI)" on page 225 for details. Situation You will be passing through a theft detector or security device You will be using potentially dangerous equipment You will be having a medical procedure Programming modes Your clinician will choose one of two programming modes, Single or Group mode in order to best meet your stimulation needs. Single modeThis programming mode allows you to adjust stimulation settings for individual pain areas. Group modeThis programming mode allows you to adjust stimulation settings for a group of pain areas. 5 n o i t l a u m i t s r u o y g n i t s u d A j 100 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 The programming mode selected by your clinician determines what is displayed on the Home screen (Figure 5.1). Single mode Group mode Figure 5.1Programming modes displayed on the Home screen. Changing parameter and stimulation settings The Home screen displays the Pain areas that your clinician has programmed for stimulation
(Figure 5.2). You may be able to adjust certain parameters and stimulation settings set up by your clinician. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 101 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Pain area buttons Single mode Group mode Figure 5.2Pain area buttons on the Home screen. Note: If you have only 1 pain area and no additional parameter or stimulation settings, you may not be able to access pain area settings through the Home screen. After pressing a Pain area button on the Home screen, the Pain area will display the available settings (Figure 5.3). 5 n o i t l a u m i t s r u o y g n i t s u d A j 102 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Exit button Settings Down button Figure 5.3Pain area settings. Refer to Table 5.2 for a description of parameter and stimulation settings and where to find information for those settings. Note: Some settings may not be available depending on what your clinician has programmed for your neurostimulator. Table 5.2Parameter and stimulation settings Button Description IntensityControls the strength of the stimulation. Refer to "Increasing or decreasing a parameter (intensity, pulse width, or rate)" on page 106. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 103 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 5.2Parameter and stimulation settings
(continued) Button Description StimulationOn or off setting for stimulation. Refer to "Turning stimulation on or off for individual pain areas" on page 110. RateSets the speed of the stimulation pulses. Refer to "Increasing or decreasing a parameter (intensity, pulse width, or rate)" on page 106. AdaptiveStimTurns AdaptiveStim on or off. This feature is only available for the implanted neurostimulator. Refer to "Turning AdaptiveStim on or off"
on page 124. Pulse widthSets the length of the stimulation pulse. It affects the strength and coverage area of the stimulation. Refer to "Increasing or decreasing a parameter (intensity, pulse width, or rate)" on page 106. 5 n o i t l a u m i t s r u o y g n i t s u d A j 104 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 5.2Parameter and stimulation settings
(continued) Button Description CyclingTurns stimulation on and off at preset times as programmed by your clinician. Refer to "Turning cycling on or off" on page 112. ProgramA custom combination of stimulation settings programmed by your clinician. Refer to "Changing a program for individual pain areas" on page 114. Note: If your neurostimulator is using Group mode, the Program setting is not available. Refer to "Viewing and changing a group" on page 115. Up/Down buttons Press to view additional parameter and stimulation settings for a pain area. These buttons may not appear depending on how your clinician has programmed your neurostimulator. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 105 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Increasing or decreasing a parameter (intensity, pulse width, or rate) Complete the following steps to adjust a parameter. Notes:
To increase a parameter, the neurostimulator must be on. To decrease a parameter, the neurostimulator may be on or off. 1. Press the Pain area button on the Home screen for the pain area you want to adjust. 5 n o i t l a u m i t s r u o y g n i t s u d A j 2. Select the parameter setting button that you want to change. If applicable, use the Up/Down buttons to view additional parameter settings. Buttons that may be available include:
Intensity (
) Pulse width (
Rate (
)
) 106 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Notes:
You may not see every parameter setting displayed on your controller. Only the parameter settings that were set up by your clinician will appear on the controller screen. Adjusting the Rate for 1 pain area will affect the rate of all other pain areas. 3. Press the Increase/Decrease key to adjust parameter settings. Press and release the Increase/
Decrease key to slowly increase or decrease parameter settings. Press and hold the Increase/Decrease key to quickly increase or decrease parameter settings. 4. Press the Exit (
) button at the top right corner of the touchscreen to exit. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 107 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Adjusting intensity for all pain areas together If your clinician has enabled the option to adjust intensity for all pain areas together, then you can quickly increase or decrease intensity on the Home screen. Discuss this option with your clinician. Notes:
To increase intensity for all pain areas together, the neurostimulator must be on. To decrease intensity for all pain areas together, the neurostimulator may be on or off. 1. From the Home screen, press the Increase/Decrease key to adjust your stimulation intensity (Figure 5.4). 5 n o i t l a u m i t s r u o y g n i t s u d A j 108 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Figure 5.4Pressing the Increase/Decrease key. All pain areas will change at the same time when you press the Increase/
Decrease key. The names of the pain areas will be replaced with the intensity values when you press the Increase/Decrease key. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 109 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Press and release the Increase/
Decrease key to slowly increase or decrease the intensity setting. Press and hold the Increase/Decrease key to quickly increase or decrease the intensity setting. 2. When you are finished adjusting intensity,
) button to lock the press the Lock (
controller. Turning stimulation on or off for individual pain areas You can turn stimulation on or off at any time. Follow these steps to turn your stimulation on or off for individual pain areas. To turn stimulation on or off for all pain areas, refer to "Turning your stimulation on or off" on page 70. 1. If you are using Single mode, press the Pain area stimulation on/off button on the Home screen (Figure 5.5). 5 n o i t l a u m i t s r u o y g n i t s u d A j 110 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Battery status button Lock button Pain area stimulation on/off buttons Menu button Pain area buttons Figure 5.5Pain area stimulation on/off button on the Home screen. 2. Or, refer to steps 35. 3. Press the Pain area button on the Home screen for the pain area you want to adjust. 4. Press the Stimulation (
) button. The Stimulation screen is shown (Figure 5.6). 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 111 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Figure 5.6Stimulation screen. 5. Press the On or Off button to turn stimulation on or off for the selected pain area. 6. Press the Exit (
) button at the top right corner of the touchscreen to exit. Turning cycling on or off 1. Press the Pain area button on the Home screen for the pain area you want to adjust. If applicable, use the Up/Down buttons to view additional stimulation settings. 2. 5 n o i t l a u m i t s r u o y g n i t s u d A j 112 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 3. Press the Cycling (
) button. The Cycling screen is shown (Figure 5.7). Figure 5.7Cycling screen. 4. Press the On or Off button to turn cycling on or off. Note: When you turn off cycling for one pain area, it will be off for all pain areas.
) button at the top right 5. Press the Exit (
corner of the touchscreen to exit. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 113 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Changing a program for individual pain areas 1. Press the Pain area button on the Home screen for the pain area you want to adjust. If applicable, use the Up/Down buttons to view additional stimulation settings.
) button. The 3. Press the Program (
2. Program screen is shown (Figure 5.8). 5 n o i t l a u m i t s r u o y g n i t s u d A j Figure 5.8Program screen. 4. Press the 1, 2, or 3 button for the program you want to select. 114 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 5. Press the Exit (
) button at the top right corner of the touchscreen to exit. Viewing and changing a group If your clinician has programmed your neurostimulator to use Group mode, you may be able to adjust your stimulation settings by selecting a different group from the Home screen. Up to 3 different groups may be available. Groups are viewed by the letters: A, B, and C. Your clinician will explain how your groups are set up to deliver stimulation and when you may want to change groups. Complete the following steps to change to a new group. To turn stimulation on or off for a group, refer to "Turning your stimulation on or off" on page 70. 1. Press the Group button on the Home screen (Figure 5.9). 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 115 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Group button Figure 5.9Home screen (group A shown). 2. Using the touchscreen or the Increase/
Decrease key, select the circle next to the desired group. (Figure 5.10). Figure 5.10Which group? screen. 5 n o i t l a u m i t s r u o y g n i t s u d A j 116 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 3. Press the OK button. The Home screen will display showing the selected group
(Figure 5.11). Figure 5.11Home screen (group B shown). Using AdaptiveStim If your clinician has programmed the AdaptiveStim feature, and AdaptiveStim is turned on, the implanted neurostimulator can automatically sense your body position and adjust the intensity of the stimulation based on your body position. Your clinician may program a maximum intensity setting based on your stimulation needs. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 117 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Note: AdaptiveStim must be turned on to view or change AdaptiveStim settings. Refer to
"Turning AdaptiveStim on or off" on page 124 to confirm that AdaptiveStim is turned on. When you are adjusting your settings for a specific position, you may need to make sure that your body is in the desired position before you make the adjustments. Discuss AdaptiveStim adjustment settings with your clinician. As you make adjustments to the intensity setting, the new setting is recorded for that position. You may need to stay in this position for up to 5 minutes before the new intensity is recorded. Your clinician can adjust this length of time, confirm the length of time with your clinician. The next time you return to this position, the stimulation intensity automatically changes to the recorded setting. For example, if you want to decrease the intensity of your stimulation when you are lying 5 n o i t l a u m i t s r u o y g n i t s u d A j 118 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 down on your back and your clinician has programmed AdaptiveStim settings so that you must be in the desired position before making adjustments, first turn off stimulation. Then get into the position, use the controller to adjust intensity to 0.0. Next, turn on stimulation and then slowly increase intensity to the desired setting for that position. Be sure to discuss your AdaptiveStim settings with your clinician. Note: When the AdaptiveStim setting is turned on, the intensity of the stimulation may not change immediately when you change positions. This delay is intentional and keeps the neurostimulator from making unnecessary adjustments based on temporary changes in your position. Your clinician can adjust the length of this delay. AdaptiveStim groups and positions Your clinician can program specific intensities for each of 7 positions or your clinician can program AdaptiveStim to adapt the intensity settings based on the adjustments you make to your stimulation while in one of the positions. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 119 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Refer to Table 5.3 for an overview of the 7 different positions recognized by AdaptiveStim. Table 5.3Positions recognized by AdaptiveStim Position graphic Description Lying Back Lying Front Lying Left Lying Right Standing Mobile 5 n o i t l a u m i t s r u o y g n i t s u d A j 120 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 5.3Positions recognized by AdaptiveStim (continued) Position graphic Description Reclining Unrecognized position Checking your body position If you want to check to make sure that the neurostimulator recognizes your body position, use the Check Position feature. 1. Press the Menu (
) button on the Home screen. 2. Select the Check Position button. The Check Position screen is shown and will display your current position and program intensities (Figure 5.12). 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 121 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Figure 5.12Check Position screen (lying back position shown). Note: If the Check Position button is not available, check to make sure AdaptiveStim is turned on. Refer to
"Turning AdaptiveStim on or off" on page 124. 3. To check a different position, move your body into the next position. 4. Press the Recheck button. The Check Position screen is shown and will display your new position and program intensities
(Figure 5.13). 5 n o i t l a u m i t s r u o y g n i t s u d A j 122 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Figure 5.13Check Position screen (standing position shown). Note: If your new position is not displayed, press the Recheck button again. It may require up to 1 minute to recognize a Mobile position. If you are still having problems with this feature, contact your clinician. 5. Press the OK button to return to the Menu screen. 6. Press the Exit (
Home screen.
) button to return to the 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 123 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Turning AdaptiveStim on or off 1. Press the Pain area button on the Home screen for the pain area you want to adjust. If applicable, use the Up/Down buttons to view additional stimulation settings. 2. 3. Press the AdaptiveStim (
) button. The AdaptiveStim screen is shown
(Figure 5.14). 5 n o i t l a u m i t s r u o y g n i t s u d A j Figure 5.14AdaptiveStim screen. 4. Press the On or Off button to turn AdaptiveStim on or off. 124 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Note: When you turn off AdaptiveStim for one pain area, it will be off for all pain areas. 5. Press the Exit (
) button at the top right corner of the touchscreen to exit. Making adjustments to AdaptiveStim If you make an adjustment to your stimulation and want to have that adjustment remembered for your current position, you may have to stay in your current position for up to 5 minutes. Your clinician can adjust this length of time, confirm the length of time with your clinician. Even with AdaptiveStim enabled, you may need to make adjustments to your stimulation. Table 5.4 provides general guidelines for adjusting your stimulation when using AdaptiveStim. 5 n o i t l a u m i t s r u o y g n i t s u d A j 977452013-04English 125 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 5.4AdaptiveStim adjustment guidelines Situation AdaptiveStim stimulation for a specific position is uncomfortable. Action While in the applicable position, decrease intensities and remain in that position for the duration programmed by your clinician. Make the desired stimulation adjustment, then get in the desired position within the time programmed by your clinician and stay there for the duration programmed by your clinician. Turn AdaptiveStim off. Turn AdaptiveStim off. Adjust your intensity to 0.0 to turn your therapy off instead of turning the neurostimulator off. You are unable to adjust AdaptiveStim stimulation while in a specific position. Stimulation becomes uncomfortable while riding in a car or another type of transportation. Stimulation becomes uncomfortable while moving in an elevator, escalator, etc. You want AdaptiveStim to turn your therapy off when in a certain position. 5 n o i t l a u m i t s r u o y g n i t s u d A j 126 English977452013-04 M948515A001Rev X2013-04
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Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 6MRI examinations M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 If you have an MRI appointment wWarning: MRI should not be prescribed for patients undergoing trial (test) stimulation or who have any neurostimulation system components that are not fully implanted. If an MRI scan is required, the clinician must explant all trial (test) stimulation components. MRI has not been tested on trial (test) stimulation components and may cause heating of the lead electrodes, resulting in tissue damage or serious patient injury. Depending on what kind of neurostimulation system components that you have implanted, you may be eligible for one of the following types of magnetic resonance imaging (MRI) scans:
MRI scans of the head only (this is referred to as head-only eligible). MRI scans of any part of your body (this is referred to as full-body eligible). 6 s n o i t i a n m a x e I R M 128 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Responsibilities of the patient in preparing for the 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 clinician that Medtronic is the manufacturer of your implanted neurostimulation system. The patient ID card also identifies your neurostimulator model number. The MRI clinician can use this information to obtain instructions to determine the eligibility of your implanted neurostimulation system for the MRI scan and the MRI scan safety conditions required by your neurostimulation system. Bring the MRI scan eligibility sheet to the MRI appointment if you were given one 6 s n o i t i a n m a x e I R M 977452013-04English 129 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 from your clinician managing your neurostimulation system. Note: The MRI scan eligibility sheet information should match what is displayed on the In MRI Mode screen of your controller. Bring your controller to every MRI appointment. However, do not take the controller 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, present your most current card to the MRI clinician. Be sure to inform the MRI clinician that you have an implanted neurostimulation system for chronic pain. If you no longer have an implanted neurostimulator, be sure to inform the MRI 6 s n o i t i a n m a x e I R M 130 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 clinician of any leads or other components that still remain implanted. To obtain the MRI guidelines, the MRI clinician can refer to the contact information at the back of this manual, or the MRI clinician can go to www.medtronic.com/mri. wWarning: Inform the MRI clinician before you enter the MRI scanner (magnet) room that you have an implanted neurostimulation system. 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 MRI scan needs to be aware of all medical implants in order to assess the conditions for safely performing your MRI scan. Determining if you are in MRI mode Be sure your stimulation is turned off and your neurostimulator is in MRI mode. Refer to the 6 s n o i t i a n m a x e I R M 977452013-04English 131 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 following instructions to determine if you are in MRI mode. 1. If necessary, unlock your controller by pressing and holding the Lock (
on the Unlock screen. You should see the In MRI Mode
) button screen. Refer to Figure 6.2 on page 136 for examples of these screens. If you see the In MRI Mode screen, you are in MRI mode. If you see the Home screen, you are not in MRI mode. Refer to "Using your controller to activate MRI mode" on page 134. Notes:
If you bring your controller to the MRI appointment, the information displayed on the In MRI Mode screen accurately displays the MRI eligibility for your neurostimulation system. If you also have an MRI eligibility sheet from your clinician, the In MRI Mode screen 6 s n o i t i a n m a x e I R M 132 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 should match the information on the MRI eligibility sheet. Placing your neurostimulation system in MRI mode for the MRI scan Your implanted neurostimulation system must be placed in MRI mode before your MRI scan. MRI mode turns stimulation off. MRI mode can be activated with your controller or with a clinician programmer. Table 6.1 shows where to go in this chapter for more information. Table 6.1Activating MRI mode With a controller With a clinician programmer See "Using your controller to activate MRI mode" on page 134. See "Visiting your clinician to activate MRI mode" on page 141. 6 s n o i t i a n m a x e I R M 977452013-04English 133 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Using your controller to activate MRI mode If you brought your controller 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. MRI mode turns stimulation off. When you activate MRI mode with your controller, stimulation is turned off and the In MRI Mode screen will appear (Figure 6.2 on page 136). Show this screen to the MRI clinician. 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 controller or you can return to the clinician managing your neurostimulation system to have stimulation turned back on. 6 s n o i t i a n m a x e I R M 134 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Activating MRI mode Complete the following steps to activate MRI mode. 1. If necessary, unlock your controller by pressing and holding the Lock (
on the Unlock screen.
) button 2. Press the Menu (
screen.
) button on the Home 3. Select the MRI Mode button. The Enter MRI Mode screen appears (Figure 6.1). Figure 6.1Enter MRI Mode screen. 4. Press the Continue button to continue. 6 s n o i t i a n m a x e I R M 977452013-04English 135 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 When MRI mode is activated, your implanted neurostimulation system has been placed in MRI mode and stimulation is turned off. In addition, one of three In MRI Mode screens will appear showing the MRI scan eligibility for your implanted neurostimulation system (Figure 6.2). The display of the In MRI Mode screen confirms that your neurostimulation system has been placed in MRI mode and stimulation has been turned off. 6 s n o i t i a n m a x e I R M Figure 6.2The In MRI Mode screen displays your MRI scan eligibility. 136 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 6.2MRI scan eligibility icons Icon combination Explanation Full-body scan eligible The implanted neurostimulation system allows the patient to be eligible to have MRI scans of any part of the body under specific conditions. The MRI clinician must consult the MRI guidelines for those conditions. Head scan eligible with transmit/
receive head coil 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. 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. 6 s n o i t i a n m a x e I R M 977452013-04English 137 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 5. Do not press any other keys or buttons. Note: The In MRI Mode screen on the controller will display for 10 minutes. The keys on the controller are disabled when in MRI mode. 6. Give your controller to the MRI clinician with the In MRI Mode screen displayed. Note: Do not take your controller into the MRI scanner (magnet) room. If you brought the recharger with you to the MRI appointment, do not take the recharger into the MRI scanner (magnet) room either.
#Caution: Do not turn stimulation back on before your MRI scan. Leaving stimulation on during the scan could increase the potential for uncomfortable, unintended stimulation. 6 s n o i t i a n m a x e I R M 138 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 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 controller or the clinician programmer:
If you do not have your controller with you, go to the clinician managing your neurostimulation system to turn stimulation on using the clinician programmer. If you brought your controller to the MRI appointment, turn stimulation back on using the controller (see the steps that follow). Complete the following steps to turn on stimulation using the controller. 1. If necessary, unlock your controller by pressing and holding the Lock (
on the Unlock screen.
) button 6 s n o i t i a n m a x e I R M 977452013-04English 139 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 2. Press the Exit MRI Mode button on the In MRI Mode screen (Figure 6.3). Figure 6.3Example In MRI Mode screen. The Stimulation is off screen appears
(Figure 6.4). 6 s n o i t i a n m a x e I R M Figure 6.4Stimulation is off screen. 140 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 3. Press one of the available buttons from the Stimulation is off screen (Figure 6.4):
Press the OK button to keep stimulation off and to return to the Home screen. Press the Turn On button to turn on stimulation and return to the Home screen. Your stimulation settings will return to how they had been programmed before you entered MRI Mode. If the Home screen is not shown after exiting MRI Mode, refer to
"Troubleshooting" on page 163. Visiting your clinician to activate MRI mode 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 6 s n o i t i a n m a x e I R M 977452013-04English 141 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 MRI examination using the clinician programmer. You may need to inform your clinician managing your neurostimulation system that an MRI examination has been prescribed for you and that you need MRI mode activated. MRI mode turns stimulation off. Do not turn stimulation back on before your MRI scan.
#Caution: Do not turn stimulation back on before your MRI scan. Leaving stimulation on during the scan could increase the potential for uncomfortable, unintended stimulation. The clinician may give you an MRI scan eligibility sheet to bring to your MRI appointment. Give the eligibility sheet to the MRI clinician. 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 6 s n o i t i a n m a x e I R M 142 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 stimulation back on using your controller or you can return to the clinician managing your neurostimulation system to have stimulation turned back on. 6 s n o i t i a n m a x e I R M 977452013-04English 143 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 6 s n o i t i a n m a x e I R M 144 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 7Using the recharging system with the implanted neurostimulator M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 This section of the manual provides instructions on how to recharge your implanted neurostimulator. The recharging system is packaged separately from the controller. Refer to the manual packaged with the recharging system for more information about the recharging system components.
#Caution: Check battery status and charge the battery regularly. Battery capacity will continue to slowly drain, even when the neurostimulator is off. If the battery becomes completely discharged, therapy will be lost. Recharging the implanted neurostimulator battery Recharging the neurostimulator battery The controller battery pack should be charged before starting to recharge the neurostimulator 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 146 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 battery. Refer to "Recharging the controller battery pack" on page 158. Only use the controller and recharger with the implanted neurostimulator listed in this manual. Charge the controller battery pack and implanted neurostimulator even if you are not using them for an extended period of time. You cannot charge the controller and neurostimulator at the same time. Your ability to locate your neurostimulator and the depth of the neurostimulator determine the efficiency of the recharging session. With practice, you will find the best location on your skin for placing your recharger. Note: Recharging quality is affected by factors such as implant depth and location. Recharging quality will vary between patients. Discuss your recharging quality with your clinician. wWarning: DO NOT use the recharger on an unhealed wound. The recharging system is 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 977452013-04English 147 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 1. not sterile, and contact with the wound can cause an infection. If desired, place the recharger head into the opening on the belt. Note: The belt is packaged with the recharging system. For more information about using the belt, refer to the manual packaged with the recharging system. 2. Plug the recharger into the controller charging port (Figure 7.1). Figure 7.1Plugging the recharger into the controller charging port. 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 148 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 3. If necessary, press and hold the Lock (
) button on the Unlock screen. The Position screen will be displayed (Figure 7.2). Figure 7.2Position screen. 4. Press your skin where your neurostimulator is located to determine the best place to position the recharger. 5. Position the recharger over your neurostimulator and press the Continue button. A series of screens will appear on the controller screen describing the recharging activity. 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 977452013-04English 149 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Note: Your recharger may make clicking noises while it searches for the neurostimulator. This is considered normal. If the recharger is able to successfully locate the neurostimulator, the Batteries screen (Figure 7.3) will display with the recharging quality. 6. Figure 7.3Batteries screen with the neurostimulator recharging quality. Notes:
The recharging light will flash green while your neurostimulator is recharging. 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 150 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Refer to Table 7.1 on page 153 for more information about recharging status indicators. 7. Press the Exit (
) button to view the Home screen. If you intend to make adjustments to your stimulation while recharging, refer to "Changing parameter and stimulation settings" on page 101. 8. Press the Lock (
) button to lock the controller while recharging. Note: When the controller is locked during the recharging process, it will still continue to recharge your neurostimulator. The recharger should remain over your neurostimulator until the recharging light is steady green and no longer flashing. When recharging is complete, the Batteries screen displays Finished (Figure 7.4). 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 977452013-04English 151 M948515A001Rev X2013-04
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Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U Figure 7.4Batteries screen with neurostimulator Finished status. Notes:
If recharging is interrupted, or issues are experienced while attempting to recharge. Refer to "Troubleshooting" on page 163 for causes and solutions. Refer to "Changing the recharging temperature and speed" on page 155 to change the recharging temperature 152 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 and speed while recharging your neurostimulator battery. Table 7.1Recharging status indicators Indicator Green flashing light Green steady light Amber flashing light Amber steady light Audio alert
(Beeping) Description Recharging is in progress. Recharging is finished. The battery is fully charged. There may be a recharging problem, see "Troubleshooting" on page 163 for information. Recharging ended due to a problem, see "Troubleshooting" on page 163 for more information. There may be a recharging problem, the controller screen may display information to help you resolve the problems. If the problem is not resolved, see "Troubleshooting" on page 163 for more information. The Audio alert is optional and can be turned on or off from the controller Menu, see "Changing the audio and vibration settings" on page 84 for instructions for setting the preferences for the Audio alert. 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 977452013-04English 153 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 To stop recharging the neurostimulator battery You can stop the recharging process at any time, even before the Batteries screen indicates that recharging is Finished. 1. If necessary, press and hold the Lock (
button on the Unlock screen.
) 2. Press the Stop button on the Batteries screen (Figure 7.5). Figure 7.5Batteries screen with the neurostimulator recharging quality. The Batteries screen will read Finished with the percentage of battery that the 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 154 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 controller and neurostimulator currently hold (Figure 7.6). 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U Figure 7.6Batteries screen with neurostimulator Finished status. 3. Press the Exit (
) button to view the Home screen. Note: If you want to continue recharging, press the Recharge button shown on the Batteries screen. Refer to "Recharging the neurostimulator battery" on page 146. Changing the recharging temperature and speed The recharging temperature and speed can only be adjusted while the neurostimulator is 977452013-04English 155 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 being actively recharged. The higher the number, the quicker and warmer recharging will be. The default recharging temperature and speed is 4. 1. Start the process for recharging the neurostimulator battery. Refer to
"Recharging the neurostimulator battery"
on page 146. If necessary, press and hold the Lock (
button on the Unlock screen.
) 2. 3. Press the Exit (
screen. 4. Press the Menu (
screen.
) button on the Batteries
) button on the Home 5. Drag the slider bar, or use the Increase/
Decrease key to view additional preferences on the Menu screen. 6. Select the Recharging button. The Recharging screen is shown (Figure 7.7). 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 156 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Figure 7.7Recharging screen. 7. Using the touchscreen or the Increase/
Decrease key, select the circle next to the desired recharging temperature and speed
(Figure 7.7). The more bars you select, and the higher the number, the faster the recharging speed and the warmer the recharger will feel while you are recharging. It is normal to feel some heat under the recharger while recharging, if this is uncomfortable, reduce the recharging speed. 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 977452013-04English 157 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 The recharging temperature and speed that you select will stay the same until you change the setting again. 8. Press the OK button to exit. 9. Press the Exit (
Home screen.
) button to return to the 10.Press the Battery status (
view the Batteries screen. Or, press the Lock (
controller.
) button to
) button to lock the Recharging the controller battery pack This procedure requires the power supply packaged with the recharging system. Refer to the manual packaged with the recharging system for more information about the power supply. The power supply cannot be used to recharge type AA batteries. 1. Plug the power supply into an electrical outlet (Figure 7.8). 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 158 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 2. Plug the connector end of the power supply into the charging port of the controller
(Figure 7.8). Figure 7.8Plug the power supply into the electrical outlet and controller charging port. Notes:
The recharging light will flash green while your controller battery pack is recharging. 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 977452013-04English 159 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Refer to Table 7.1 on page 153 for more information about recharging status indicators. 3. Press and hold the Lock (
) button on the Unlock screen. The controller will display the Batteries screen (Figure 7.9). Figure 7.9Batteries screen with the controller recharging status. 4. Press the Exit (
screen.
) button to view the Home 5. Press the Lock (
) button to lock the controller while recharging. 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 160 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Note: The controller should be locked while recharging the battery pack to help speed up the recharging process. When the controller battery pack is completely charged, the recharging light will be steady green and no longer flashing. The Batteries screen displays Finished
(Figure 7.10). Figure 7.10Batteries screen with controller Finished status. 6. To complete recharging the controller battery pack at any time, unplug the power supply from the controller charging port. 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 977452013-04English 161 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 7 r o t a u m l i t s o r u e n d e t n a p m l i e h t h t i w m e i t s y s g n g r a h c e r e h t i g n s U 162 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 8 Troubleshooting M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 This chapter will help you if you are experiencing problems with your Controller. It also provides information on when to call your clinician. Note: If you cannot solve a problem or if your problem is not described here, contact your clinician. Controller screens The controller displays three different types of screens: warning screens, alert screens, and notification screens. These screens provide you with information about your system, alert you to a problem with your system, or guide you during controller use. Icon Description Red triangle with an exclamation point Orange triangle with an exclamation point Blue circle with the letter 'i'
Screen type Warning screen Alert screen Notification screen 8 g n i t o o h s e b u o r T l 164 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Warning screens Warning screens indicate a problem with the controller, recharger, or neurostimulator. Table 8.1 describes the possible warning screens and provides instructions (see blue text) on how to resolve the problem and clear the screen. If the warning screen is not resolved using the instructions in Table 8.1, write down the message on the screen and the number in the bottom right corner of the warning screen, and call Medtronic or your clinician. 8 g n i t o o h s e b u o r T l 977452013-04English 165 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Message Table 8.1Warning screens Cause and action The controller batteries are depleted. Programming is not available. Recharge the controller battery pack now. Refer to
"Recharging the controller battery pack" on page 158. The controller batteries are depleted. Programming is not available. Replace the controller batteries now. Refer to
"Replacing the type AA controller batteries" on page 206. 8 g n i t o o h s e b u o r T l 166 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.1Warning screens (continued) Message Cause and action The implanted neurostimulator batteries are depleted. Stimulation is not available. Recharge the implanted neurostimulator. Refer to
"Recharging the implanted neurostimulator battery" on page 146. The external neurostimulator batteries are low and stimulation will not be available soon. Write down the message on the screen and the screen number in the bottom right corner. Do not replace the external neurostimulator batteries by yourself. Call your clinician. Press the OK button to exit this screen. 8 g n i t o o h s e b u o r T l 977452013-04English 167 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.1Warning screens (continued) Message Cause and action The ENS button on the external neurostimulator is stuck in the pressed position. Press and release the ENS button, then press the OK button to clear the screen. If this does not solve the problem, write down the message on the screen and the screen number in the bottom right corner, and call your clinician. The controller battery pack is low and the controller is unable to recharge the implanted neurostimulator battery. Recharge the controller battery pack. Refer to
"Recharging the controller battery pack" on page 158. Press the OK button to exit this screen. 8 g n i t o o h s e b u o r T l 168 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.1Warning screens (continued) Message Cause and action The external neurostimulator may have reached its end of service (EOS) and needs to be checked by your clinician. Stimulation is not available. The implanted neurostimulator needs to be checked by your clinician. Stimulation is not available. Write down the message on the screen and the screen number in the bottom right corner, and call your clinician. The neurostimulator therapy settings are not complete. Write down the message on the screen and the screen number in the bottom right corner, and call your clinician. 8 g n i t o o h s e b u o r T l 977452013-04English 169 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.1Warning screens (continued) Message Cause and action The external neurostimulator lead door was open while attempting to adjust stimulation. Close the lead door on your external neurostimulator. Retry adjusting your stimulation settings. If you cannot easily close the door, contact your clinician. Press the OK button to exit this screen. There is a problem with the recharger. The recharger will not be able to recharge your implanted neurostimulator. Disconnect the recharger from the controller. Write down the message on the screen and the screen number in the bottom right corner, and call Medtronic. Press the OK button to exit this screen. 8 g n i t o o h s e b u o r T l 170 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.1Warning screens (continued) Message Cause and action Your controller is using type AA batteries. Type AA batteries cannot be used to recharge an implanted neurostimulator. Replace the controller batteries with the battery pack. Refer to the recharging system user manual for instructions on replacing the battery pack. If you do not have a battery pack, call Medtronic. Press the OK button to exit this screen. 8 g n i t o o h s e b u o r T l 977452013-04English 171 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.1Warning screens (continued) Message Cause and action The software is not working correctly. Stimulation may have stopped. Write down the message on the screen and the screen number in the bottom right corner, then follow these steps:
1. Remove and reinsert the controller batteries, then retry the action that caused the error screen to appear. If this does not solve the problem, call Medtronic. 2. 8 g n i t o o h s e b u o r T l 172 English977452013-04 M948515A001Rev X2013-04
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Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.1Warning screens (continued) Message Cause and action The system is not working correctly. Stimulation may have stopped. Note: Disregard the alpha-
numeric code shown. It is used by Medtronic only. Write down the message on the screen and the screen number in the bottom right corner, then follow these steps:
1. Remove and reinsert the controller batteries, then retry the action that caused the error screen to appear. If this does not solve the problem, call Medtronic. 2. Alert screens Alert screens indicate a pairing or other connection problem between the controller, recharger, or neurostimulator. 8 g n i t o o h s e b u o r T l 977452013-04English 173 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.2 describes the possible alert screens and provides instructions (see blue text) on how to resolve the problem and clear the screen. Message Table 8.2Alert screens Cause and action The controller batteries are low. Programming will not be possible soon. Replace the controller batteries now. Refer to
"Replacing the type AA controller batteries" on page 206. Press the OK button to exit this screen. The controller batteries are low. Programming will not be possible soon. Recharge the controller battery pack soon. Refer to
"Recharging the controller battery pack" on page 158. Press the OK button to exit this screen. 8 g n i t o o h s e b u o r T l 174 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.2Alert screens (continued) Message Cause and action The implanted neurostimulator battery is low. Recharge the implanted neurostimulator soon. Refer to "Recharging the implanted neurostimulator battery" on page 146. Press the OK button to exit this screen. The implanted neurostimulator has reached the elective replacement point. The implanted neurostimulator will stop providing stimulation soon. Call your clinician. Press the OK button to exit this screen. 8 g n i t o o h s e b u o r T l 977452013-04English 175 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.2Alert screens (continued) Message Cause and action The implanted neurostimulator battery is too low to support MRI mode. Do not get an MRI scan without first recharging your implanted neurostimulator, then access MRI mode. Refer to "Recharging the implanted neurostimulator battery" on page 146. Press the OK button to exit this screen. 8 g n i t o o h s e b u o r T l 176 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.2Alert screens (continued) Message Cause and action The controller cannot find the paired external neurostimulator. The external neurostimulator may be out of range or the batteries may be depleted. Move the controller closer to the external neurostimulator and make sure your hand is not covering the top of the controller, then press the Try Again button. If this does not solve the problem, the external neurostimulator batteries may need to be replaced. Write down the message on the screen and the screen number in the bottom right corner, and call your clinician. Press the Exit (
exit this screen.
) button to 8 g n i t o o h s e b u o r T l 977452013-04English 177 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.2Alert screens (continued) Message Cause and action The controller cannot find the paired implanted neurostimulator. The implanted neurostimulator may be out of range or the battery may be depleted. If the recharger is connected to the controller, reposition the recharger over your implanted neurostimulator and press the Recharge button. If the recharger is not connected to the controller, move the controller closer to your implanted neurostimulator and make sure your hand is not covering the top of the controller, then press the Try Again button. If this does not solve the problem, your implanted neurostimulator may need to be recharged. Press the Exit (
exit this screen.
) button to 8 g n i t o o h s e b u o r T l 178 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.2Alert screens (continued) Message Cause and action The controller is unable to recharge your implanted neurostimulator due to a poor connection between the controller and implanted neurostimulator. Position the recharger over the implanted neurostimulator, and press the Try Again button. Press the Cancel button to exit the screen without continuing to recharge. 8 g n i t o o h s e b u o r T l 977452013-04English 179 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.2Alert screens (continued) Message Cause and action The controller is unable to recharge your implanted neurostimulator because it was unable to find your implanted neurostimulator, or there was a poor connection between the controller and the implanted neurostimulator. Position the recharger over the implanted neurostimulator, and press the Restart button. Press the Cancel button to exit the screen without continuing to recharge. 8 g n i t o o h s e b u o r T l 180 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.2Alert screens (continued) Message Cause and action A problem has occurred during recharging of the implanted neurostimulator that is preventing the controller from recharging the implanted neurostimulator. Press and hold the Lock (
button. The next screen will identify the problem that has occured. Refer to the
"Troubleshooting" on page 163 to identify the cause of the problem and actions needed.
) 8 g n i t o o h s e b u o r T l 977452013-04English 181 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.2Alert screens (continued) Message Cause and action A problem has occured during recharging of the implanted neurostimulator that is preventing the controller from recharging the implanted neurostimulator. Position the recharger over the implanted neurostimulator so that the highest number is shown in the bottom center of the screen. If the controller successfully starts recharging the implanted neurostimulator, the Batteries screen will be shown. Refer to "Recharging the neurostimulator battery"
on page 146. Notification screens Notification screens provide information about therapy settings, error conditions, and battery levels. 8 g n i t o o h s e b u o r T l 182 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.3 describes the possible notification screens and provides instructions on how to proceed (see blue text) when these messages appear. Table 8.3Notification screens Message Cause and action The recharger cable has become disconnected from the controller. Reconnect the recharger cable to the controller. Press the OK button to exit this screen. You tried decreasing your stimulation below the lowest value allowed. Press the OK button to exit this screen and return to the lowest allowed setting. If you are feeling discomfort, call your clinician. 8 g n i t o o h s e b u o r T l 977452013-04English 183 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.3Notification screens (continued) Message Cause and action There was a problem with the controller memory, which caused the controller preferences to be lost. Press the OK button to exit this screen. Follow the on-
screen instructions until you see the Finished screen. If this does not solve your problem, write down the message on the screen and the screen number in the bottom right corner, and call Medtronic. 8 g n i t o o h s e b u o r T l 184 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.3Notification screens (continued) Message Cause and action Your combined settings cannot be delivered by the external or implanted neurostimulator. This is sometimes referred to as out-
of-regulation or OOR. If the implanted neurostimulator battery is low, recharge it. Refer to
"Recharging the implanted neurostimulator battery" on page 146. Switch to a different program, refer to "Changing a program for individual pain areas" on page 114. Or, switch to a different group, refer to "Viewing and changing a group" on page 115. If you are not receiving symptom relief, call your clinician. Press the OK button to exit this screen. 8 g n i t o o h s e b u o r T l 977452013-04English 185 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.3Notification screens (continued) Message Cause and action You tried to increase your stimulation when stimulation was off. Press the Turn On button on the controller screen to turn stimulation on, then try adjusting stimulation again. To keep stimulation off and not change settings, press the OK button to exit this screen. You tried increasing your stimulation above the highest value allowed. You can not increase your stimulation any higher. Press the OK button to exit this screen and return to the highest allowed setting. If you are not receiving symptom relief, call your clinician. 8 g n i t o o h s e b u o r T l 186 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Possible problems and solutions Table 8.4 will help you solve problems or identify when to call your clinician. Instructions are provided in (blue text) on how to resolve the problem. If a problem is not solved after several attempts, or if a problem is not described here, contact your clinician. 8 g n i t o o h s e b u o r T l 977452013-04English 187 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Problems Uncomfortable stimulation: You are too uncomfortable with the current stimulation to think about how to change it. Table 8.4Troubleshooting problems Causes and actions The selected group or stimulation settings are not suitable for your current activity or posture. Turn the neurostimulator off. Reduce the intensity for each pain area or group. Change the group if the active program is not one that is recommended by your clinician for your current activity or posture;
or adjust the intensity, pulse width, and rate to values that provide adequate pain relief. If this does not eliminate the problem, call your clinician. 8 g n i t o o h s e b u o r T l 188 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.4Troubleshooting problems
(continued) Problems Uncomfortable warmth while recharging: You experience uncomfortable warmth from the recharger while recharging the implanted neurostimulator. Causes and actions Your recharger is too hot to work properly. Allow the recharger to cool. Store the recharger and controller in a cool, dry place. Your skin is too warm for a successful recharging session. Move to a cool location, remove any excess clothing, allow your skin temperature to cool. Lower the recharging temperature and speed, refer to "Changing the recharging temperature and speed" on page 155. 8 g n i t o o h s e b u o r T l 977452013-04English 189 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.4Troubleshooting problems
(continued) Problems Intermittent stimulation:
You feel stimulation only some of the time. No stimulation: You do not feel stimulation but you think stimulation should be on. Causes and actions Your clinician may have programmed your neurostimulator to turn on and off at regular intervals. If you are not receiving adequate pain relief, contact your clinician. Stimulation is off. Use your controller to turn your stimulation on. The intensities for each program in the active pain area(s) or group are set too low to feel. Use your controller to increase the intensities. 8 g n i t o o h s e b u o r T l 190 English977452013-04 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.4Troubleshooting problems
(continued) Problems Delayed stimulation changes: You do not feel stimulation right away after turning on the neurostimulator or you feel stimulation after turning off the neurostimulator. Controller is unresponsive: The display screen is blank when you press a key. Causes and actions Your clinician programmed SoftStart/Stop so that stimulation starts and stops gradually. Allow about 8 seconds for your neurostimulator to turn on and off. You may feel a residual effect after the neurostimulator is turned off. The controller batteries are depleted. Replace the controller batteries. If you have an implanted neurostimulator, recharge the controller battery pack. The controller batteries are in backwards. Check the battery polarity and reinstall the controller batteries. 8 g n i t o o h s e b u o r T l 977452013-04English 191 M948515A001Rev X2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 05-01-2012 Table 8.4Troubleshooting problems
(continued) Problems Dropped controller: Your controller falls off a cabinet or table. Fluid on the controller:
Fluid was spilled onto the controller or the controller was dropped into water. Causes and actions The controller is designed to withstand a short drop to a hard surface and still operate normally, even if the case is chipped or nicked. Try the controller; it should work. The controller is not waterproof, and water can damage the device. Immediately remove the controller from the water, then dry the controller with a towel dampened with clean tap water. Remove the batteries or battery pack, then allow the battery compartment to air dry at room temperature for 24 hours. 8 g n i t o o h s e b u o r T l 192 English977452013-04 M948515A001Rev X2013-04
1 2 | ID Label | ID Label/Location Info | 603.75 KiB |
97745 MR Rx only FCC ID: LF597745 IC:3408D-MPPGR4 M947531A003 SEE SHEET 2 ORIENT ARROWS AS SHOWN SEE SHEET 2 A DOCUMENT RELEASE 12-01808 02MAY12 CEP CF
.05 LB-IN TORQUE. 05 LB-IN TORQUE. NOTES 1 ASSEMBLY SHALL MEET ALL REQUIREMENTS CONTAINED IN THE RELATED ENGINEERING BILL OF DOCUMENTS, BILL OF MATERIALS AND SPECIFICATIONS. 2 PRESS-FIT BATTERY CONTACT INTO CASE HALF BOTTOM. BATTERY CONTACT MUST BE FULLY SEATED AGAINST STOPS IN CASE HALF BOTTOM. 3 TIGHTEN SCREWS F/N 9 TO 2.00 4 TIGHTEN SCREWS F/N 10 TO 1.50 5 CLEAN DOME CONTACT AREAS ON PWB WITH ISOPROPYL ALCOHOL PRIOR TO ASSEMBLING DOME SHEET TO PWB. REMOVE DOME SHEET FROM RELEASE LINER AND LOCATE ON PCB WITH PROVIDED TOOLING HOLES. 6 LCD FLEX TAIL AND VIBRATOR MOTOR TO BE CONNECTED TO RESPECTIVE RECEPTICAL ON PCB. 7 LABELS TO BE LOCATED WITHIN SILK SCREEN OUTLINES ON PCB. ORIENTATION TO MATCH SILK SCREEN POLAIRITY INDICATORS 8 SERIAL NUMBER / BARCODE LABEL TO BE ADHERED TO RECESS IN CASE BOTTOM ASSEMBLY. 9 LABEL TO BE APPLIED TO RECESS IN BATTERY DOOR. ORIENTATION TO BE RIGHT READING, AND SAME DIRECTION AS LOGO ON ACCENT BAND. 10 REMOVE ADHESIVE LINER ON ACCENT BAND BEFORE INSTALLING. ACCENT BAND TO BE FULLY SEATED ON CASE HALF BOTTOM. 11 A PROTECTIVE FILM SHALL BE PLACED OVER LCD LENS. SUPPLIER LABELS ON THE PROTECTIVE FILM ARE ALLOWED, BUT CANNOT BE PLACED OVER DISPLAY AREA. 12 UPON APPROVAL BY MEDTRONIC, INC. OF THE INITIAL DESIGN, ANY PROCESS CHANGES, DESIGN CHANGES OR DEVIATIONS CONSIDERED BY THE MANUFACTURER SHALL BE SUBMITTED TO MEDTRONIC, INC. IN WRITING FOR REVIEW. IF CHANGES ARE SUBMITTED FOR APPROVAL, THE INFORMATION SUBMITTED SHALL INCLUDE A COMPLETE DESCRIPTION OF THE CHANGE AND THE EFFECT THE CHANGE WILL HAVE ON ALL CHARACTERISTICS OF THE DEVICE/MATERIAL. UPON REQUEST, THE MANUFACTURER SHALL SUBMIT SAMPLES OF THE PROPOSED DEVICE/MATERIAL FOR THE EVALUATION AND APPROVAL BY MEDTRONIC, INC. 13 CLEAN MATING AREA ON CASE HALF BOTTOM CORRESPONDING TO ADHESIVE AREA ON ACCENT BAND WITH ISOPROPYL ALCOHOL PRIOR TO ASSEMBLY. TITLE DATE 23MAR12 DRAFTING C. PETERS ENGINEERING C. FERRARO DEVICE ASSEMBLY - PTM, INTELLIS
. DO NOT SCALE PRINT DIMENSIONS ARE IN INCHES THE CAD DATA FOR THIS PART NUMBER CAN BE MADE AVAILABLE UPON REQUEST X.X .1 X.XX .01 X.XXX .005 X.XXXX .0005 ANGLES 1.0 D E S I G N D O C U M E N T TYPE FIRST DESIGNED FOR MODEL NEXT ASSY
REV SIZE DOCUMENT NUMBER SHEET D M951956A A 1 OF 2 CAD MODEL: EMPTY STOP IN CASE HALF BOTTOM 2 PLACES VIEW SHOWN WITH F/N 17 REMOVED SCALE 4.000 DOCUMENT NUMBER REV SHEET M951956A A 2 OF 2
1 2 | Agent Authorization letter | Cover Letter(s) | 174.85 KiB |
Federal Communications Commission Laboratory Division 7435 Oakland Mills Rd Columbia, MD 21045 Attn: Joe Dichoso, Chief, Equipment Authorization Branch Joe.Dichoso @fcc.gov Dear Mr. Dichoso,
|, the undersigned, as the authorized signatory for Medtronic, Inc., grantee code LF5, hereby authorize Anne Coldwell of Medtronic, Inc., to act on my behalf in all manners relating to the following applications for equipment authorization, including signing of all documents relating to this application:
Description FCC ID Orn Clinician Programmer LF58880CW CTM2 = Clinician Telemetry Module LF58880T2 PTM3 Personal Therapy Manager, Intellis LF597745 ae Recharge Therapy Manager LF597755 ENS External Neuro Stimulator, Intellis ola eae) External Neuro Stimulator, Interstim LF53531 Personal Therapy Manager, Interstim LF53537 Personal Therapy Manager LF537745 Any and all acts carried out by Anne Coldwell of Medtronic, Inc. on our behalf shall have the same effects as acts of my own. This authorization shall be sent along with each application when filing with the FCC or TCB for certification of products covered by the above specified FCC IDs.
(next page) Charles S. Farlow Senior Program Manager, Systems Engineering Medtronic Cardiac Rhythm Disease Management 8200 Coral Sea Street NE, MVC83 Mounds View, MN 55112 March 20, 2012 Page 1 of 2 Fe LD ate ae ced Be a ss a If there are any questions related to this letter, please contact me at charles.s.fariow @ medtronic.com (+1 763 742 5158). MA Respectfully, Oritclelccme we mrclilel iy
(een Phillip Inglis, TRP Inc. Page 2 of 2
1 2 | Antenna Info | Operational Description | 75.73 KiB |
Antenna Information for PTM Model 97745 The PTM Model 97745 uses two antenna's. The main Telemetry-M antenna is a multi-turn helical antenna soldered into the bottom of the PCB assembly. The Bluetooth antenna is a PCB antenna. No replacement of antennas is required. The Bluetooth antenna used in the PTM Model 97745 is a monopole antenna incorporated into the Printed Circuit Board. Therefore the specific antenna will be used in all cases by default. The Bluetooth antenna used in the PTM Model 97745 is a part of the PCB and has no model number. It is manufactured by Medtronic, Inc and is a planar monopole antenna. The gain for the PTM3 Bluetooth antenna is -1.37 dBi. The primary Telemetry-M antenna is manufactured by Medtronic and has a maximum gain of 0 dBi. Telemetry-M Antenna Bluetooth Antenna
1 2 | Compliance Opinion | Cover Letter(s) | 21.24 KiB |
FCC Compliance Opinion WTD 12.7.3 Information about the Applicant Grantee (Company Name) FCC Contact Person Address City, State, Zip Job Number Model FCC ID Agent Approval Type Equipment Class Medtronic Inc. Charles Farlow 7000 Central Avenue NE Minneapolis, MN 55432 MDTR0182 97745 LF597745 Anne Coldwell Original DSS Part 15 Spread Spectrum Transmitter TNB Licensed Non-Broadcast Station Transmitter 15.247, 95 I Rule Part Overview Medtronic, Inc. is submitting this application for the original certification of their Clinician Telemetry Module (CTM2), model 97745, FCC ID LF597745. Model 97745 is a portable device which acts as a communications link from a Clinician Programmer to an Implantable Medical Device. The Model 97745 contains a Bluetooth v2.0+ EDR transceiver, and a FCC part 95I transceiver operating in the 400 MHz MICS band. Confidentiality requested for allowed files. Request is properly addressed and referenced. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 10/23/2012 MDTR0182
1 2 | Cover letter | Cover Letter(s) | 94.33 KiB |
ir/Madam, his is an application for FCC approval of the Intellis Model 97745 Patient Therapy Manager with Bluetooth and MICS transceivers for original certification. est data and applicable documents required for certification are included in the accompanying documentation. The test data provided shows that Model 97745 meets the requirements of FCC Part 15.247, and 95. Medtronic, Inc. therefore requests FCC certification for the PTM. ederal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Medtronic, Inc. 7000 Central Avenue Northeast Minneapolis, MN 55432 Model No: 97745 Description: _ Intellis Patient Therapy Manager (PTM aoe |e adhe aft] Suspuaixy - YIpvaP] Dussorsey - umm] dunDlagy Anne Coiawe Director, Quality and Reliabilit
1 2 | Request for Confidentiality | Cover Letter(s) | 27.89 KiB |
We also request the exhibits listed below as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. External Photographs Test Setup Photographs User's Manual Internal Photographs Any exhibit information for which we have requested confidentiality, but which ma not be accorded such treatment by the FCC, should be returned to us. The documents listed above contain trade secrets that are treated as confidential by us. Substantial competitive harm to us could result should they be made available to the public. Sincerely,
-August-2012 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Medtronic, Inc, Request for Confidentiality FCC ID NO: LF597745 To whom it may concern, We hereby respectfully request that under the provision of 47 CFR 0.459 and 0.457(d the documents listed below and attached with this application for certification be MAC em Aimee erie CHIC IEE Ie e Schematics e Theory of Operation e Frequency Block Diagrams ronic Alleviating Pain Restoring Health - Extending Life Director, Quality and Reliabili
1 2 | Tuneup Procedure | Parts List/Tune Up Info | 22.27 KiB |
To whom it may concern, The Intellis Patient Therapy Manager (PTM) Model 97745 device does not have a procedure or a method to update the output power levels of the transmitter once in the field or even if the PTM has been shipped back to Medtronic. If the unit has been damaged, the customer will return the damaged unit and will receive anew PTM from the factory that has passed all manufacturing tests. Re: Attestation of Tune Up Procedure
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2012-10-26 | 402 ~ 405 | TNB - Licensed Non-Broadcast Station Transmitter | Original Equipment |
2 | 2402 ~ 2480 | DSS - Part 15 Spread Spectrum Transmitter |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2012-10-26
|
||||
1 2 | Applicant's complete, legal business name |
Medtronic, Inc.
|
||||
1 2 | FCC Registration Number (FRN) |
0008250839
|
||||
1 2 | Physical Address |
8200 Coral Sea Street NE
|
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1 2 |
Mounds View, 55112
|
|||||
1 2 |
United States
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
d******@nwemc.com
|
||||
1 2 | TCB Scope |
B2: General Mobile Radio And Broadcast Services equipment in the following 47 CFR Parts 22 (non-cellular) 73, 74, 90, 95, 97, & 101 (all below 3 GHz)
|
||||
1 2 |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
|||||
app s | FCC ID | |||||
1 2 | Grantee Code |
LF5
|
||||
1 2 | Equipment Product Code |
97745
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
G******** G******
|
||||
1 2 | Title |
Sr. RF Regulatory Program Manager
|
||||
1 2 | Telephone Number |
763-5********
|
||||
1 2 | Fax Number |
651-3********
|
||||
1 2 |
G******@medtronic.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 04/24/2013 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | TNB - Licensed Non-Broadcast Station Transmitter | ||||
1 2 | DSS - Part 15 Spread Spectrum Transmitter | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | 97745 | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Output power is conducted. The antenna(s) used for this transmitter must not be collocated or operating in conjunction with any other antenna or transmitter within a host device, except in accordance with FCC multi-transmitter product procedures. | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Northwest EMC, Inc.
|
||||
1 2 | Name |
G****** K****
|
||||
1 2 | Telephone Number |
503-8********
|
||||
1 2 | Fax Number |
503-8********
|
||||
1 2 |
g******@nwemc.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 95I | 402.00000000 | 405.00000000 | 0.0000640 | 4.2000000000 ppm | 64K8F1D | ||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0029100 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC