kinetra , soletra, and itrel ii 8870 - boala parkinson tehnice/dbs-prog8870-gd.pdf · part #...

Part # M221233A004

Software Application CardProgramming Guide for Software Version A—12/03

Rx Only

Kinetra®, Soletra®, and Itrel® IINeurostimulators for Deep Brain Stimulation (DBS™)

8870

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Part # M221233A004Inside Front cover—For Position Only—Do Not Print!

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Medtronic Confidentialreference_R00

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Software Application Card - 8870 Programming Guide Version A

Kinetra®, Soletra®, and Itrel® II Neurostimulators for Deep Brain Stimulation (DBS™)


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The following are trademarks of Medtronic®:

Medtronic®, Itrel®, and Activa® are registered trademarks of Medtronic. Kinetra®, Soletra®, N’Vision™, Access™, Access Review™, DBS™, and SoftStart™ are trademarks of Medtronic.

About This Manual

Movement Disorder Programming Guide, Version A–12/03 iii


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About This Manual

This Programming Guide is a reference manual supporting Medtronic Kinetra, Soletra, and Itrel II Neurostimulation Systems. Each neurostimulator has its own technical manual packaged with the device.

Note: Discussions on Itrel II in this manual are limited to the indications of Activa Parkinson’s Control Therapy and Activa Tremor Control Therapy.

Organization of this guide is divided into the following sections:

Section 1: Introduction – This section provides general disclosure information regarding the Kinetra, Soletra, and Itrel II Neurostimulator Systems, along with information about system components.

Section 2: N’Vision Clinician Programmer – This section describes the N’Vision Programmer and provides basic programmer information. For detailed instructions on the use of the N’Vision Programmer, refer to the technical manual packaged with the device.

Section 3: Programming – Section 3 provides information on programming the Kinetra, Soletra, and Itrel II Neurostimulators using the Model 8840 N’Vision Clinician Programmer and the 8870 Application Card. Information on programmable features and step-by-step programming instructions are provided.

Section 4: Troubleshooting – This section contains information for the most common stimulation problems. The purpose of this section is to guide and direct the clinician if problems arise during programming of the neurostimulator.

Section 5: Programming at a Glance – Section 5 contains a brief overview of the most commonly used programming features.

Glossary – A glossary for this Programming Guide is provided.

About This Manual

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Table of contents

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Table of contents

About This Manual iii

1. Introduction

Intended Use 2Warnings 2Precautions 4System Overview 6

Neurostimulator 6Leads and Extensions 6N’Vision Clinician Programmer 7Application Card 7Patient Components 8

2. N’VISION Clinician Programmer

Programming Head 3Printer 3

3. Programming

Before You Begin 2Icon Identification 3Using Demo Mode 4Programming Overview 5

Basic Programming Steps 6Beginning a Programming Session 9

Overview 9Interrogate the Neurostimulator 11Enter Patient Information on the Profile Screen 12Quick Look Screen 17Turning on the Neurostimulator 19

Programming Stimulation Settings 20Programming Electrode Polarities 23Programming Pulse Width, Rate, and Amplitude 27Charge Density 37

Programming Parameters on the Special Screen 39Special Screen 39

Using the Data Screen 52Overview 52Recommendations When Using Measurement Functions 53Data Screen Components 54

Programming a Neurostimulator for Patient Control 57The Therapy Controller and Limits 58

Table of contents

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Patient Limits 59Programming Restrictions 61Programming Patient Limits 62

Reviewing and Printing from the Summary Screen 65

4. Troubleshooting

No Telemetry or Error Messages 3No Telemetry Checklist 4Noninvasive Troubleshooting for No Telemetry or Other Error Messages 4

No Stimulation or Intermittent Stimulation 10Causes of No Stimulation or Intermittent Stimulation 10

Changes in Symptom Suppression 18Causes of Change in Therapy Response 18

Ineffective Stimulation 19Patient-related Causes for Ineffective Stimulation 19Etiology-related Causes for Ineffective Stimulation 19

5. Programming at a Glance

Typical Programming Procedures 2

A. Glossary

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1Introduction

This chapter provides general disclosure information regarding the Kinetra, Soletra, and Itrel II Neurostimulator Systems used for Activa Parkinson’s Control Therapy and Activa Tremor Control Therapy, along with information about system components.

Intended Use 1-2

Warnings 1-2

Precautions 1-4

System Overview 1-6

IntroductionIntended Use

1-2 Movement Disorder Programming Guide, Version A–12/03



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Intended Use

The 8870 Application Card is intended for use with the Medtronic Model 8840 N’Vision Clinician Programmer in programming Medtronic implantable neurostimulators and pumps.

This manual addresses programming of the:

■ Kinetra Model 7428 Neurostimulator

■ Soletra Model 7426 Neurostimulator

■ Itrel II Model 7424 Neurostimulator

Warnings

The N’Vision Programmer can only be used to program Medtronic Neurological devices that correspond with therapy application software on the Model 8870 Application Card.

Model 8529 Magnet – The Model 8529 Magnet may be attached to the Model 8840 programming head and is for use with Medtronic SynchroMed and SynchroMed EL pumps only. Remove the magnet before using the N’Vision Programmer with Medtronic neurostimulators.

Special Ramp – Do not use Special Ramp with Soletra or Itrel II for deep brain stimulation. Consult the appropriate neurostimulator manual for additional information.

Cycling Mode – Do not use Cycling Mode with Soletra or Itrel II for deep brain stimulation. Consult the appropriate neurostimulator manual for additional information.

Sterile Field – When using the programmer in a sterile field, place the programmer and programming head into a sterile bag. The programmer is not sterile and cannot be sterilized.

IntroductionWarnings




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Avoid Excessive Stimulation – There is a potential risk of brain tissue damage for stimulation parameter settings of high amplitudes and wide pulse widths.

The Activa System is capable of parameter settings out of the range of those used in the clinical studies. Suppression of symptoms should occur at amplitudes of 1 to 3.5 V, pulse widths of 60 to 120 µsec, and rates of 130 to 185 Hz. Higher amplitudes and pulse widths may indicate a system problem or less than optimal lead placement. Parameter values exceeding the recommended output settings should only be programmed with due consideration of the warnings concerning charge densities and charge imbalance (Soletra Model 7426 and Itrel II Model 7424).

If programming of stimulation parameters exceeds charge density limits, the following programmer warning appears: WARNING: CHARGE DENSITY MAY BE HIGH ENOUGH TO CAUSE TISSUE DAMAGE.

The use of rates less than 30 pps may “drive” tremor, i.e., cause it to occur at the same frequency as the programmed frequency. For this reason, rates should not be programmed below 30 pps.

IntroductionPrecautions




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Precautions

Programming Head Placement – If the programming head is not properly positioned over the neurostimulator, programmed parameters may not change. The programming head must be held steadily over the neurostimulator while telemetry is in progress.

For all parameters except amplitude, a status bar on a pop-up screen will be displayed to indicate telemetry in progress. The progress of amplitude programming is displayed on the Programming Screen (refer to page 3-20).

Programming Preparation – Initiate programming only after careful study of the appropriate technical manuals for all components. Refer to the appropriate technical manual for a complete list of indications, contraindications, warnings, precautions, and adverse events.

Reprogramming – Program parameter changes gradually and in small increments or undesirable stimulation can result.

Storage – Do not use the N’Vision Programmer or Application Card if they were transported or stored at temperatures above or below the specified temperature range of -40° - 149°F (-40° - 65°C). Allow the equipment to stabilize to a temperature within the operating range of 48° - 105°F (10° - 40°C) before using it to program.

Electromagnetic Interference – Do not use the N’Vision Programmer in the proximity of equipment that generates electromagnetic interference (EMI). EMI may cause a disruption in programmer function. Examples of common medical sources of EMI are magnetic resonance imaging (MRI) and lithotripsy. Computer monitors, cell phones, x-ray equipment, and other monitoring equipment may also generate EMI. Refer to the appropriate technical manual for a list of EMI sources.

Application Card – Do not force the Application Card into the programmer. Do not insert nonMedtronic, generic application cards into the N’Vision Programmer.

Telemetry – Radio signals (telemetry) from the physician programmer may interfere with the performance of other implantable devices.

IntroductionPrecautions




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Custom Limits – In the Kinetra application, custom limits should always be set as a final step in programming, prior to printing a final review. The limits often change when using the clinician programmer to program new settings for amplitude, amplitude resolution, pulse width, or rate. By programming custom limits last, you ensure accuracy and save time otherwise required to reprogram.

Sensitivity to Stimulation – Patients with extremely high sensitivity to stimulation may sense the transmission of the programming signals.

IntroductionSystem Overview




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System Overview

Neurostimulator

Neurostimulators produce electrical pulses for neurostimulation and have a wide range of programmable parameters and modes. The Kinetra Model 7428 Neurostimulator is designed to accommodate two extensions. The amplitude, pulse width, and electrode polarities are set independently for each program; allowing parameter values for the right side to be different from those for the left side.

Note: The Soletra and Itrel II Neurostimulators provide single-program stimulation.

Figure 1-1. Kinetra, Soletra, and Itrel II Neurostimulators

Leads and Extensions

Leads and extensions connected to the neurostimulator deliver electrical stimulation to specific areas of the brain.

7428

Model 7424 Itrel II Neurostimulator

Model 7426 Soletra Neurostimulator

Model 7428 Kinetra Neurostimulator





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N’Vision Clinician Programmer

The N’Vision Clinician Programmer is used to program the stimulation parameters and modes of the neurostimulator via telemetry, the radio-frequency communication between the implanted device and the programming device.

Figure 1-2. N’Vision Clinician Programmer

Application Card

The 8870 Application Card is a plug-in card that contains the necessary software to program the Kinetra, Soletra, and Itrel II Neurostimulators.

Each neurostimulator has a unique recognition code that allows the programmer to use the appropriate software during programming.

N'VISION

P





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w Warning: Do not use the N’Vision Clinician Programmer and the installed Application Card to program any devices other than associated Medtronic neurostimulators and pumps. If an attempt to program an incompatible device is made, an error message will appear on the programmer.

♦ Procedure – To install the Application Card

# Caution: Do not force the Application Card into the programmer.

1. Insert the Application Card (arrow and bar code side facing up) in the direction of the arrow into the card slot until it is seated in place.

2. Pull the ejection button out and flip it down and to the side until it is flush with the opening.

Refer to the “Getting Started” card packaged with the N’Vision Programmer for programmer set up instructions.

Note: Do not remove the application card from the programmer once it is installed. Removal of the card during programming can cause data loss.

Patient Components

Therapy Controller

Therapy controllers are hand-held, battery-powered devices. The therapy controllers used with Kinetra, Soletra, and Itrel II turn the neurostimulators on and off and check neurostimulator battery status. The therapy controller used with Kinetra can also adjust the amplitude, pulse width, and rate for one or two programs within physician-approved stimulation limits programmed with the N’Vision Programmer.

Control Magnet

The Model 7452 Control Magnet allows patients to turn off and on their neurostimulators. Additionally, the patient can use the control magnet to select a normal or low amplitude setting on the Itrel II Neurostimulator.

Table 1-1 summarizes the functions of the system components. For detailed information on individual system components, refer to the associated technical manuals and/or Instructions for Use (IFU) sheets. For detailed information on programming the neurostimulators, refer to “Programming Overview” on page 3-5.





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Table 1-1. System Component Function

Component Function

Neurostimulator Produces electrical pulses to stimulate specific areas of the brain and is programmable.

Leads and Extensions

Deliver electrical stimulation from neurostimulator to specific areas of the brain.

Programmer with Application Card

Switches neurostimulator on and off.Programs stimulation parameters.

Kinetra Soletra Itrel II

Programs 1 and 2Amplitude and LimitsPulse Width and LimitsRate and LimitsElectrode Polarity

AmplitudePulse WidthRateElectrode Polarity

AmplitudePulse WidthRateElectrode Polarity

Selects or programs stimulation modes and special functions.

Kinetra Soletra Itrel II

Patient Control; Cycling; Day Cycling; SoftStart/Stop

Cycling; SoftStart/Stop; Special Ramp; Dose; Dose Lockout; Rate Modulation; Pulse Width Modulation

Cycling; SoftStart/Stop; Special Ramp; Dose; Dose Lockout; Magnet Amplitude; Rate Modulation; Pulse Width Modulation

Activates measurement functions for all neurostimulators: Neurostimulator Stimulation Current, Neurostimulator Battery Capacity, Lead Impedance, Patient Use Data.Configures neurostimulator for use with patient programmer and control magnet.

Patient Control Devices

Model 7452 Control MagnetTherapy Controller: Switches neurostimulator on and off; monitors neurostimulator, patient programmer batteries status (Kinetra, Soletra, and Itrel II); adjusts amplitude, pulse width, and rate for one or two programs within clinician-programmed limits (Kinetra only).





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2N’VISION Clinician Programmer

Section 2 describes the Model 8840 N’Vision Clinician Programmer and provides basic programmer information. For detailed instructions on the use of the programmer, refer to the technical manual packaged with the device.

Programming Head 2-3

Printer 2-3

N’VISION Clinician Programmer




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The N’Vision Clinician Programmer is used to review and program (via telemetry) neurostimulator parameters and modes. Figure 2-1 is a representation of the N’Vision Programmer and its components.

Figure 2-1. N’Vision Clinician Programmer and Components

Note: Install the programmer batteries before use. For installation instructions, refer to the technical manual or “Getting Started” card packaged with the programmer.

The programmer is a hand-held, portable device that offers a single platform for Medtronic Neurological therapies and applications. The programmer is equipped with a touch screen for data entry and device programming and has an infrared (IR) port through which communication can be established with compatible printers.

Before using the programmer for the first time; refer to the “Getting Started” card for information on:

■ Insert the batteries

■ Insert the application card

■ Power up the programmer

■ Set localization options

N'VISION

Therapy Stop Button

Scroll Wheel

Programming Button

Application Card Port

Power Switch

Programming Head

Battery Compartment

Stylus Storage

Telemetry Cable Wheel

IR Port





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Programming Head

Telemetry is a means of communication between the implanted device and the programmer via the programming head. Telemetry occurs during all programming sessions.

The N’Vision Clinician Programmer telemetry head can be used while docked to the programmer or extended on a cable that reels out from the programmer.

During each telemetry sequence, an indicator light on the programming head indicates proper positioning over the neurostimulator and successful communication.

Printer

The optional Model 3445 Seiko DPU Printer communicates with the N’Vision Programmer via IR signals (Figure 2-2).

Figure 2-2. Model 3445 Seiko DPU Printer

Note: Most standard desktop printers with IR capability and with protocol IrDA 1.0 may also be used with the programmer.

Before printing, ensure that the IR port on the programmer is facing the IR lens of the printer and within 1 meter (39.4 in) of the printer, then select the print option from the Slider Bar on the N’Vision Programmer touch screen or select the printer icon in the title bar of the applications. Detailed printing instructions are provided in Chapter 3 of this manual.





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3Programming

Section 3 provides information on programming the Kinetra, Soletra, and Itrel II Neurostimulators using the N’Vision Programmer and Application Card. Information on programmable features and step-by-step programming instructions are provided.

Before You Begin 3-2

Icon Identification 3-3

Using Demo Mode 3-4

Programming Overview 3-5

Beginning a Programming Session 3-9

Programming Stimulation Settings 3-20

Programming Parameters on the Special Screen 3-39

Using the Data Screen 3-52

Programming a Neurostimulator for Patient Control 3-57

Programming Restrictions 3-61

Reviewing and Printing from the Summary Screen 3-65

ProgrammingBefore You Begin




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Before You Begin

Prior to using the Model 8840 N’Vision Clinician Programmer, verify that the programmer is properly set up. Refer to the technical manual packaged with the programmer or the “Getting Started” card in the programmer package to ensure that the programmer is ready for use. Observe the following precautions before initiating a programming or review session.

# Cautions:

■ Do not attempt telemetry in the proximity of equipment that generates electromagnetic interference (EMI). EMI may cause a disruption in programmer function. Examples of common medical sources of EMI are magnetic resonance imaging (MRI) and lithotripsy. Computer monitors, cell phones, x-ray equipment, and other monitoring equipment may also generate EMI.

■ Radio signals (telemetry) from the physician programmer may interfere with the performance of other implantable devices.

w Warning: When using the programmer in a sterile field, place the programmer and programming head into a sterile bag. The programmer is not sterile and cannot be sterilized.

Ensure that the application card is properly installed. Refer to the technical manual packaged with the N’Vision Programmer.

Note: The programming head must be properly positioned over the neurostimulator and held steadily while telemetry is in progress. A light on the programming head will flash amber if telemetry is attempted, but not established, or if telemetry is established, then interrupted. A flashing green light on the programming head indicates successful communication between the implanted device and the programmer. A pop-up screen on the programmer will include a status bar that tracks the progress of the telemetry. When communication is successful and complete, the pop-up screen will disappear.

ProgrammingIcon Identification




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Icon Identification

Some of the most common status and screen icons used in programming are provided below for reference.

Patient Profile Screen Icon IR Port Status

Quick Look Screen Icon Printer Status

Programming Screen Icon

Programming Head Present

Special Screen Icon

Communication Established with Programming Head

Data Screen Icon

No Communication Established with Programming Head

Summary Screen Icon

Magnet Present on Programming Head

High Battery Status (Programmer) Demo Mode

Medium Battery Status (Programmer)

EOL Battery Status (Programmer)

ProgrammingUsing Demo Mode




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Using Demo Mode

A demo mode is available on the N’Vision Clinician Programmer. To access the Demo Mode, touch the stylus to the Demo Mode button (Figure 3-1).

Figure 3-1. Demo Mode

The Demo Mode allows the user to navigate through all of the screens and programming functions used during patient sessions. If desired, use the Demo Mode as a simulation to familiarize yourself with the interface prior to using the programmer during an actual patient session.

Demo ModeButton

Note: The neurostimulator icon is inactive (“slashed” through) in Demo Mode.

ProgrammingProgramming Overview




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Programming Overview

Programming of neurostimulators and therapy parameters is accomplished through the touch screen of the Model 8840 N’Vision Clinician Programmer. Refer to the technical manual packaged with the programmer for an overview of basic programmer functions.

The programming parameters are located on various screens that are accessed by contact of the stylus with the tabs associated with the screens.

Tab icons and the functions and features of the screens associated with the tabs are described briefly below. Detailed descriptions of these screens and their functions are provided later in this chapter.

Profile Screen: Patient and device configuration information are entered on the Profile Screen. The information entered here is carried through onto the remaining screens. This information needs to be entered only the first time that the neurostimulator is interrogated, unless a different application card is used for a subsequent interrogation.

Quick Look Screen: This screen provides information about current neurostimulator settings, including device parameters, patient control, and patient use. Parameters cannot be programmed on this screen; however, when a specific parameter on this screen is touched with the stylus, the programmer transfers the user to a screen that allows programming of that parameter.

Programming Screen: This screen is used for programming device parameters, including: electrode polarity; amplitude; pulse width; and rate.

Special Screen: This screen is used to program “special” parameters such as SoftStart, patient control, cycling, and magnet amplitude.

Data Screen: Various device measurements are taken from this screen, including: electrode impedance, therapy measurements, and battery information.





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Summary Screen: The Summary Screen is used as a final check of device settings after programming of all parameters is completed. Counters are cleared from this screen. The clinician can abandon all session programming and return the neurostimulator to the settings programmed prior to the start of current session. Additionally, the print reports function is accessed from this screen.

Basic Programming Steps

Note: Some areas on the programmer display may be “greyed out” during programmer use. “Greyed out” areas are not accessible during programming. Refer to page 3-19 for more information.

Table 3-1 presents an overview of the basic steps for a typical programming session with the application card and the programmer.

w Warning: Before approaching the patient, remove the Model 8529 Magnet from the programmer. The magnet may turn the patient’s implanted device on or off.

Table 3-1. Programming Overview: Basic Programming Steps

To: Do This:

1. Turn the programmer on. Pull backward on the power button on the programmer, and hold momentarily before releasing.

2. Navigate to the neurostimulationdesktop for programming.

Select the neurostimulator icon on the touch screen.

3. Initiate telemetry between theneurostimulator and the programmer.

Position the programming head over the implanted device and hold the programming head steady.

4. Interrogate the device. Press the programming (P) key on the side of the programmer. The light on the back of the programming head will flash green while telemetry is ongoing and will stop flashing when telemetry is finished.

Hold the programming head steadily over the device until the interrogation is complete.

A pop-up screen with a status bar will indicate the progress of the telemetry and will disappear when communication has been established between the device and the programmer.





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5. Enter patient information. If necessary, select the Profile Screen tab. Enter the patient ID and lead location using the stylus to select letters from the pop-up keyboard (the keyboard appears when the stylus makes contact with these areas). Enter the number of leads by selecting “1” or “2” with the stylus. If appropriate, select “Renumber Electrodes.”

6. Select lead(s) and Electrode Polarity Navigate to the Programming Screen. Negative, positive, and off values for the electrodes are toggled by using the stylus to select the electrodes. If available, the case can also be programmed with stylus touch.

7. Select Pulse Width and Rate. Using the stylus, select the rectangular field under pulse width or rate. A pop-up screen allows the user to select the desired rate or pulse width.

8. Program. Hold the programming head over the neurostimulator, and press the programming (P) key.

9. Select Amplitude. Using the stylus, select the amplitude input box. A pop-up screen allows the user to select the desired amplitude. As the amplitude increases, each distinct increase in amplitude is actually programmed as the amplitude continues to increase.

10. Set Cycling Parameters. Access the Special Screen and select Cycling from the drop-down box. Program desired parameters.

11. Set Patient Control parameters. Access the Special Screen and select Patient Control from the drop-down box. Program desired parameters.

12. Verify parameters on theSummary Screen

Access the Summary Screen. Verify that intended parameters have been programmed.

13. Clear counters If necessary, access the Summary Screen. Using the stylus, select the Clear Counters button.

14. Print reports Select the print option from the Slider Bar on the programmer touch screen or select the printer icon in the title bar of the application.

Table 3-1. Programming Overview: Basic Programming Steps (Continued)

To: Do This:





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Note: Remember that the N’Vision Programmer allows for batch programming of some parameters. You may set all target parameters on one screen, then program all parameters at once before navigating to a different screen.

ProgrammingBeginning a Programming Session




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Beginning a Programming Session

Overview

This section contains detailed information on programming the Kinetra, Soletra, and Itrel II Neurostimulators with the 8870 Application Card and Model 8840 N’Vision Clinician Programmer.

To ensure that the programmer is ready for use, follow the set-up instructions in the “Getting Started” card packaged with the programmer.

When your programmer turns on and passes the self-test, the “Application Selection Screen” (Figure 3-2) will appear.

Figure 3-2. Application Selection Screen

Number of files available to print

Percentage of memory used





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Notes:

■ When the percentage of memory used approaches 100%, delete files that you no longer need from the data session manager.

■ If the Model 8529 Magnet is affixed to the programmer, a pop-up screen will appear when you initiate telemetry, reminding you to remove the magnet. Remove the magnet and retry the telemetry attempt.

Once you have selected an application, the Therapy Desktop will appear (Figure 3-3), and you will see the following message: Caution: Turn INS output on before all parameter adjustments, especially amplitude and pulse width.

Figure 3-3. Therapy Desktop





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Interrogate the Neurostimulator

Position the programming head over the implanted device. Press the programming (P) button. The programmer will automatically identify the INS (implantable neurostimulator) model that is implanted. A pop-up screen will appear on the programmer, and a status bar will indicate telemetry progress (Figure 3-4).

Figure 3-4. Status Bar Indicating Telemetry Progress

When the status bar disappears, you may begin programming.

Notes:

■ The screens presented on the following pages are representative of specific Medtronic neurostimulator applications. Not all features represented are available on all neurostimulator models.

■ If no information has been entered into the Profile Screen prior to interrogation of an Itrel II, the programmer will display a screen asking you to select the appropriate therapy.





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Enter Patient Information on the Profile Screen

For new patients, neurostimulator default settings (set at shipping) should appear when the device is interrogated; for existing patients, the most recent programmed settings should appear.

The first time that a specific 8870 Application Card is used with a patient, you will be prompted to enter patient information on the Profile Screen (Figure 3-5).

Figure 3-5. Patient Profile Screen

Device SerialNumber

Note: During patient sessions, the neurostimulator icon is active.





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Using the Keyboard

The keyboard pops up when the stylus contacts some input boxes that require alpha-numerical input. Four keyboards are available:

The arrow at the bottom left of the screen is used to toggle the keyboard between upper and lower case alpha characters (Figure 3-6). The circular arrow to the left of the space bar changes to the keyboard to foreign and special character displays.

Keyboard 1 Keyboard 2

Keyboard 3 Keyboard 4





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♦ To enter patient information:

1. Select the Profile Screen tab.

2. Using the stylus, touch the input box under the Patient ID field. A keyboard appears (Figure 3-6).

Figure 3-6. Entering Patient Information

Pop-upkeyboard

Enter patient identification information here.

Close Keyboard

Enter

Backspace

Space Bar





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3. Using the stylus, enter the patient Identification and any other desired information in the input boxes of the “Enter patient ID” field.

4. Select the number of leads to match the patient configuration. If appropriate, choose the “Renumber electrodes” (if lead connection to the neurostimulator is different than pictured). If the configuration you are using is not depicted on the screen, select a configuration that allows access to all available electrodes.

Note: You cannot change from a 2-lead configuration to a 1-lead configuration unless all electrodes are programmed off and amplitude and tracking limits are set to 0V on the program you intend to shut off.

5. Using the stylus, you may enter lead location in the input box next to that field. When you touch inside the input boxes, a pop-up keyboard will appear. Using the stylus, key in lead location using the letters on the keyboard.

The information you enter on the Patient Profile Screen will automatically carry over to the other screens. The neurostimulator model and session date will appear at the top of the Quick Look and Summary Screens (Figure 3-7).

Figure 3-7. Position of Neurostimulator Model and Session Date

NeurostimulatorModel and Session

Date





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Note: If the neurostimulator has undergone a Power On Reset (POR), all programmed settings and the neurostimulator serial number will be lost. The first review of the neurostimulator settings after a POR will result in the message POWER ON RESET HAS OCCURRED, along with the following pop-up message.

The pop-up keyboard will appear with the message above. Enter the serial number (located in your patient’s records) or press cancel.

Note: If at any time, telemetry fails, the following pop-up screen will appear, giving you the option to continue or cancel the session.





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Quick Look Screen

Note: If the neurostimulator has been previously programmed with the 8870 Application card you are presently using, the patient profile information will already be stored, and the Quick Look Screen will appear following successful telemetry (Figure 3-8). The screen will contain the patient information you entered previously.

Figure 3-8. Quick Look Screen





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The Quick Look Screen allows you to access other screens where you can program parameters. For example, if you touch the area containing amplitude, pulse width, and rate information, the Programming Screen will appear. Similarly, if you touch any area within the Patient Control box, the Special Screen will appear; patient control parameters are programmed on this screen.

Patient Use Data

Patient use data provide you with information about patient use of the neurostimulator.

Patient use data are accessed from the Quick Look Screen (Figure 3-9).

Figure 3-9. Accessing Patient Use Data

Patient Use Data





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Parameters that are available for review include: hours used (the number of hours the neurostimulator was ON and the amplitude was greater than 0V); last reset (date of last counter reset, i.e., last follow up examination);% used (time stimulation is on divided by total time); and battery status (neurostimulator battery status).

Turning on the Neurostimulator

The neurostimulator on/off function is accessed through the neurostimulator icon located at the top right of all the screens (Figure 3-10). The on/off function is a toggle selection. To turn the neurostimulator on or off, touch the neurostimulator icon with the stylus. The neurostimulator icon reflects the status of the neurostimulator as on

or off.

Note: When target values have not yet been programmed (when values are pending), many functions are not available. For example:

■ When amplitude is pending, electrode polarity, pulse width, and rate are not accessible.

■ When any target value is pending, navigation between tabs is not possible.

■ When invalid electrode configurations are selected, the program (P) button can not be selected.

■ When special ramp is selected, cycling options are inaccessible.

Inaccessible functions such as those listed above are “greyed out” on the screen.

Patient use data also include the number of neurostimulator activations. That number is defined as the number of times the neurostimulator was turned on with a magnet (Soletra and Itrel II) or with a magnet or a clinician or patient programmer (Kinetra).

# Caution: Patients with extremely high sensitivity to stimulation may sense the transmission of the programming signals.

ProgrammingProgramming Stimulation Settings




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Programming Stimulation Settings

Programming Screen

Turn the neurostimulator on (Figure 3-10). The neurostimulator will turn on at the settings to which it was last programmed, or to shipping parameters, if you are programming the device for the first time.

The Kinetra Neurostimulator can be programmed with separate amplitudes, pulse widths, and electrode polarities for each program (side).

A typical sequence for programming stimulation settings consists of the following steps:

1. Program electrode polarities (refer to page 3-23).

Note: Changing polarity automatically pends the amplitude to 0V.

Figure 3-10. Program Electrode Polarities

Using the stylus,select the electrode

you wish to program.The electrode will

change fromnegative(-),

positive (+), or off(blank) each time the

stylus contactsthe electrode.

Neurostimulator On/Off Icon





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2. Program pulse width and rate (refer to page 3-27).

Figure 3-11. Set Pulse Width and Rate for Program 1

3. When you are finished selecting pulse width and rate, use the stylus to select the programming button. To cancel changes made on the screen before programming, select the “Clear pending” button.

4. Program amplitude (refer to “Amplitude” on page 3-30).

Using the stylus,select the PW

input box. A list ofselectable pulse

widths will appear.Choose the desired

pulse width value.

Using the stylus, select the Rate input box. A list of selectable rates will appear. Choose the desired rate value.





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Figure 3-12. Set Amplitude for Program 1

5. When you select a greater amplitude for programming, the amplitude will begin to “ramp” automatically, unless the auto-increase function is turned off. To interrupt the amplitude ramp before it is complete, use the stylus to select the stop ramp ( ) button.

6. If configuring two programs, repeat the previous steps for Program 2.

Using the stylus, select the Amplitude input box. A list of selectable amplitudes will appear. Choose the desired amplitude value. (Alternative methods for programming are presented beginning on page 3-31)





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Programming Restrictions

Electrode Polarity – Note the following restrictions when programming electrode polarity:

■ If a bipolar configuration is desired, any polarity combination may be selected as long as at least one electrode is positive, one electrode is negative, and the neurostimulator case is off.

■ If a unipolar configuration is desired, the neurostimulator case must be selected as the only positive electrode; the lead electrodes may be programmed in any combination of negative or off as long as at least one electrode is negative.

Notes:

■ Amplitude cannot be programmed if values are pending.

■ Invalid polarity programming parameters will not be accepted by the programmer. If you have selected invalid polarity combinations, the Program button will remain “greyed out”.

Programming Electrode Polarities

To program electrode polarities:

1. Using the stylus, select the Programming Screen (Figure 3-13).

2. On the lead to be programmed, use the stylus to toggle the appropriate electrode through the “-,” “+,” or blank (off) options until the desired value appears.





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Electrode Polarity

Programmable polarity settings consist of a cathode (a negative “pole” designated on the programmer display with a “-” sign on the graphic electrodes) and an anode (a positive “pole” designated on the programmer display with a “+” sign on the graphic electrodes and neurostimulator case) (Figure 3-13). Any of the electrodes and the neurostimulator case can also be programmed off (designated on the screen by the absence of a “+” or “-” sign).

Figure 3-13. Programming Electrode Polarities

Notes:

■ The amplitude changes to 0V when polarity settings are changed.

■ Rate is not independently programmable for two programs. (Refer to the information on using two programs on page 3-25).

Negative Electrode

Positive Electrode

ElectrodeProgrammed Off

NeurostimulatorCase





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Programs

A program is a specific combination of amplitude, rate, and pulse width parameters, acting on a specific electrode combination.

The Kinetra Neurostimulator has two available programs, designated on the Programming Screen as (left side) and (right side).

The two separate programs allow for stimulation with different amplitudes and pulse widths, and for different electrode polarities within each program.

The same rate value is programmed for Program 1 and Program 2 with the Kinetra Neurostimulator.





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3. Repeat Step 2 to program the neurostimulator case (Figure 3-14).

Figure 3-14. Programming the Case

4. Verify that the desired program is selected and ensure desired values are selected for each program.

5. Press the “Program” button, or set remaining parameters prior to programming.

Neurostimulator Case(programmed on)





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Programming Pulse Width, Rate, and Amplitude

After electrode polarity is selected, input values for the following parameters:

Rate

Rate is the frequency or speed [in hertz (Hz)] of the stimulation pulses.

The rate parameter is not independently programmable between Program 1 and Program 2 with Kinetra. To program rate, first program the rate at a value between 130-160 Hz for the lead and electrodes controlling the side of your patient’s body where symptoms are the most obvious or intense. Then, program the amplitude and pulse width for that lead. Use the amplitude and pulse width that you programmed for the first lead as a baseline for programming amplitude and pulse width for the second lead.

Note: Remember that if you change the rate on one lead the rate on the second lead automatically changes to match the revised rate.

♦ To program the rate:

1. Using the stylus, touch the rate input box (Figure 3-15).

Figure 3-15. Program Rate

2. A list of available rate options will appear. Select the target value.

Rate Input Box





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3. In the rate input box, both the actual and target rate settings will appear, with an arrow pointing from the original setting to the target rate.

4. Press the “Program” button.

5. Once programmed, the new rate setting will appear in the rate input box.

Note: For Kinetra, the rate is not independently programmable for both programs, so it is only necessary to set the rate values once.

# Caution: Patients with extremely high sensitivity to stimulation may sense the transmission of the programming signals.

Pulse Width

Pulse width is the duration (in µsec) of a pulse.

# Caution: Always decrease the amplitude to 0V before changing pulse width. After the change, slowly increase the amplitude to avoid unpleasant stimulation to the patient.

♦ To program the pulse width:

1. Using the stylus, touch the pulse width input box on the programming screen (Figure 3-16).





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Figure 3-16. Program Pulse Width

2. A list of available pulse width options will appear. Select the target value.

3. In the pulse width input box, both the actual and target pulse width settings will appear, with an arrow pointing from the original setting to the newly selected pulse width.

4. Press the “Program” button, or set remaining parameters prior to programming.

5. Once programmed, the new pulse width setting will appear in the pulse width input box.

Pulse Width Input Box





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Amplitude

Note: Ensure that the neurostimulator is on prior to programming to avoid unpleasant stimulation for the patient.

Amplitude is the strength or intensity (in volts) of a stimulation pulse. Amplitude can be programmed in one of three ways:

■ using incremental steps;

■ using preset parameters; or

■ using the scroll wheel.

Notes:

■ If you have requested an increase in the amplitude, but you wish to stop the increase while it is ramping, you may do so by touching the stop ramp icon ( ) just below the amplitude setting box, or by depressing the scroll wheel one time.

■ The amplitude can also be set to 0V by touching the down arrow with the line under it . This icon is positioned to the right of the amplitude setting box, just under the up and down arrows (Figure 3-17).

Amplitude auto-increase feature – The auto-increase feature must be enabled to allow for automatic ramping of amplitude increases while programming (Figure 3-18). When auto-increase is enabled, the amplitude will increase automatically at the rate selected in the auto-increase input box.





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♦ To program the amplitude using incremental steps:

1. Using the stylus, select the up (increment) or down (decrement) arrow in the amplitude box (Figure 3-17).

Figure 3-17. Programming Amplitude

2. When you touch the up or down arrow with the stylus, the amplitude will start to change or “ramp.”

Note: If you are increasing the amplitude, the target amplitude may increase faster than the actual amplitude. In the amplitude input box, you will see the actual amplitude as it increases, followed by an arrow pointing to the target amplitude (Figure 3-19). If you are decreasing the amplitude by steady contact with the down arrow, the amplitude will decrease at a non-specific rate until the target amplitude is achieved.

The programmer will automatically program the change incrementally, until the target value is reached. There is no need to touch the Program button.

Amplitude Setting Box

Amplitude Increase (Increment)

Amplitude Decrease (Decrement)

Set Amplitude to 0 volts

Stop Amplitude Ramp up





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Note: If you touch the Program button while the amplitude is still increasing, the programmer will immediately set the amplitude to the target value.

♦ To program the amplitude using preset parameters:

1. Using the stylus, touch the input box where the actual amplitude is displayed (Figure 3-18).

2. A list of possible amplitudes will appear (Figure 3-18). Select a target amplitude. After you select a target amplitude, the selection box will close.

Figure 3-18. Selecting Preset Amplitude Values

If the desired amplitude is greater or less than the target chosen, use the up or down arrow to reach the exact target.

Note: Available amplitudes may be limited dependent upon the programmed pulse width and rate. Refer to Table 3-2 to determine if a desired amplitude is unavailable (grayed out) due to incompatible rate or pulse width parameters.

Available Amplitude Settings

Auto-increase feature





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Table 3-2. Maximum programmable amplitudes at high rates and pulse widths

Programmed Pulse Width (µsec)

Limited Amplitude at High Rates (Hz)

130 150 175 200 220 250

90 NONE NONE 10.4 9.9 9.5 9.1

120 10.4 10.0 9.5 9.0 8.6 8.1

180 9.2 8.7 8.1 7.6 7.0 6.4

240 8.3 7.7 7.1 6.6 6.0 5.5

300 7.3 6.8 6.2 5.7 5.4 5.0

360 6.8 6.2 5.6 5.0 4.7 4.3

420 6.4 5.9 5.3 4.8 4.5 4.1

450 6.0 5.5 4.8 4.2 3.8 3.4





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Figure 3-19. Target Amplitude Ramp

The programmer will automatically program or ramp incremental increases in amplitude until the target value is reached, if the auto-increase feature is enabled.

As the amplitude ramps, the actual amplitude is presented on the left, followed by an arrow pointing to the target amplitude.





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♦ To program the amplitude using the scroll wheel

1. While on the Programming Screen, depress the scroll wheel on the side of the programmer to activate the scroll wheel (Figure 3-20).

Figure 3-20. Programming Amplitude Using the Scroll Wheel

2. A scroll wheel icon will appear to the left of the amplitude input box on the screen.

3. While the icon is visible, each distinct up turn of the scroll wheel increases the amplitude, and each distinct down turn of the scroll wheel decreases the amplitude.

The programmer will automatically increment or “ramp” the amplitude until the target value is reached.

Note: The target value can be immediately reached by pressing the programming key on the side of the programmer (Figure 3-20).

P Scroll Wheel

Programming Key





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4. When you have reached the desired amplitude, depress the scroll wheel to deactivate the amplitude icon.

Notes:

■ If you have requested an increase in the amplitude, but you wish to stop the increase while it is ramping, you may do so by touching the stop ramp icon ( ) just below the amplitude setting box, or by depressing the scroll wheel one time.

■ The amplitude can also be set to 0 by touching the down arrow with the line under it . This icon is positioned to the right of the amplitude setting box, just under the up and down arrows (Figure 3-17).

Amplitude Resolution

Amplitude resolution can be selected on the Programming Screen (Figure 3-21). To change amplitude resolution, select the amplitude input box on the Programming Screen. In the amplitude resolution box, select the desired amplitude resolution.

Figure 3-21. Programming Amplitude Resolution





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Charge Density

A survey of literature regarding electrical stimulation of neural tissue suggests that damage may occur above 30 microcoulombs/cm2/phase. The Activa System is capable of producing charge densities in excess of 30 microcoulombs/cm2/phase.

The maximum programmable amplitude for neurostimulators used with the Activa System is 10.5 V, and maximum pulse width is 450 microseconds. The curved lines in Figure 3-22 represent a charge density of 30 microcoulombs/cm2/phase at various impedance measurements, calculated for the electrode surface area of the Model 3387/3389 DBS leads. Mean resistance found in the Activa clinical studies were as follows.

■ Tremor clinical studies (Vim): 1387 ohms(range: 453-1999 ohms).

■ Parkinson’s disease clinical studies (all targets): 1294 ohms (range: 415-1999 ohms).

■ Parkinson’s disease clinical studies (GPi): 1161 ohms(range: 415-1967 ohms).

■ Parkinson’s disease clinical studies (STN): 1177 ohms(range: 628-1926 ohms).

Charge density is determined by plotting a point corresponding to the pulse width setting (x-axis), and the amplitude setting (y-axis). If this point is below the appropriate resistance curve, then the charge density is below 30 microcoulombs/cm2/phase. Points above the curve indicate a charge density above 30 microcoulombs/cm2/phase.

The shaded area in Figure 3-22 indicates a charge density above 30 microcoulombs/cm2/phase at the conservative impedance estimate of 500 ohms. If stimulation parameters are selected that fall into the shaded area of the graph, the following programmer warning appears: WARNING: CHARGE DENSITY MAY BE HIGH ENOUGH TO CAUSE TISSUE DAMAGE. Programming may continue at the desired values (refer to the appropriate software applications manual for further information).

Figure 3-22 includes two examples of charge density calculated for the 8840. In Example A, the neurostimulator stimulation parameters are set to: amplitude = 3.0 V and pulse width = 90 µsec. The charge density for





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Example A is below the shaded warning zone, thus indicating a charge density below 30 microcoulombs/cm2/phase at the most conservative impedance of 500 ohms.

In Example B, neurostimulator stimulation parameters are set to: amplitude = 6.1 V and pulse width = 210 µsec. The charge density at these settings is in the shaded area indicating it may be high enough to cause tissue damage at an impedance of 500 ohms. However, as shown in Figure 3-22, if the impedance in this case is at the clinical mean from either the tremor clinical study or the Parkinson’s disease clinical studies, the charge density would be below 30 microcoulombs/cm2/phase.

Figure 3-22. Charge densities with clinical studies resistance values

0

2

4

6

8

10

12

0 50 100 150 200 250 300 350 400 450

500 Ohms (Charge Density Warning)

GPi - 1161 Ohms (mean resistance from Parkinsons Clinical study)

STN - 1177 Ohms (mean resistance from Parkinsons Clinical study)

Vim - 1387 Ohms (mean resistance from Tremor Clinical study)

2000 Ohms

{

Example A

Example B

+

+

WARNING AREA

DBS Amplitude and Pulse Width Limits

Computed to resistances ranging from 500 to 2,000 ohms

DBS Lead Surface Area = 0.06 cm2

Charge Density Threshold = 30 Microcoulombs/cm2/phase

Am

plitu

de (

V)

Pulse Width (µsec)

ProgrammingProgramming Parameters on the Special Screen




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Programming Parameters on the Special Screen

Special Screen

Several special programmable parameters and features are available on the Special Screen to prolong battery life and assist in patient comfort and convenience. Features on this screen include:

■ Kinetra: Patient control; cycling; day cycling; SoftStart/Stop.

■ Soletra: Cycling, special ramp; dose; dose lockout; control magnet; patient control; SoftStart/Stop; rate modulation; pulse width modulation.

■ Itrel II: Cycling; special ramp; dose; dose lockout; magnet amplitude; rate modulation; pulse width modulation; SoftStart/Stop; control magnet.

This section discusses programming of many of these features. Because patient control parameters are typically programmed at the end of a patient session, programming of patient control features is discussed at the end of this chapter.

Note: You do not need to program each parameter individually on the Special Screen. You may set all target values for each drop-down box function and then program.

Stimulation Modes

w Warning: For the Soletra and Itrel II Neurostimulators, use only Continuous Mode for Deep Brain Stimulation. The potential for a charge imbalance condition exists if Cycling and/or Special Ramp Modes are programmed. DO NOT program to Cycling or Special Ramp Modes for these neurostimulators.

■ Continuous Mode – stimulation is continuous.

■ Cycling Mode – stimulation is cycled on and off automatically.

These modes can be modified by two programmable features that increase patient comfort and convenience:

■ SoftStart/Stop: amplitude is gradually increased as stimulation starts and gradually decreased as stimulation stops.





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■ Day Cycling: provides a method of synchronizing Day Cycling ON and OFF times with the 24-hour clock. For example, stimulation can be programmed to stop automatically at night and resume in the morning (Kinetra only).

Continuous Mode

In Continuous Mode, stimulation is continuous or unchanging. Output is determined by previously programmed values for amplitude, pulse width, and rate.

All neurostimulators have programmed default values of Continuous Mode. Therapies will operate in Continuous Mode unless the Cycling or Special Ramp Modes are programmed.

SoftStart/Stop

The SoftStart/Stop feature can be used in conjunction with Continuous Mode and with most Cycling Modes. SoftStart allows the amplitude to increase gradually (ramp up) over a specified period from 0V to the selected amplitude value. This feature is intended to increase patient comfort by providing a gentle or “soft” start as stimulation begins. The SoftStop feature causes the output to decrease gradually to 0V (ramp down) when the stimulation is turned off. Use of the SoftStart/Stop feature helps to avoid any unpleasant sensation at the onset of stimulation. For Kinetra, programmable ramp times for this feature (up and down) are 1, 2, 4, or 8 seconds. SoftStart/Stop ramp times for the Itrel II and Soletra are automatically programmed.





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♦ To program SoftStart/Stop:

1. Access the Special Screen (Figure 3-23).

2. In the drop down box, select Cycling.

3. Using the stylus, touch the SoftStart/Stop input box. A list of available values will display.

4. Select the desired value.

5. Using the stylus, select the Program button.

Figure 3-23. Programming SoftStart/Stop

SoftStart/Stop





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Cycling Mode

w Warning: Do not use cycling mode with Soletra or Itrel II. Consult the appropriate neurostimulator manual for additional information.

In Cycling Mode, stimulation is automatically cycled on and off, and the output is determined by programmed selection of: Cycling On times, and Cycling Off times (in seconds, minutes, or hours).

The Cycling Mode may extend battery life while maintaining good symptom suppression. Due to the “carryover” effect, the patient may continue to experience symptom suppression during the Cycling Off time of the Cycling Mode.

♦ To program the neurostimulator for Cycling Mode:

1. Access the Special Screen (Figure 3-24).

Figure 3-24. Programming Cycling Mode

2. In the drop-down box, select Cycling.

3. Using the stylus, touch the Mode input box. Contact of the stylus with this area toggles the selection between Cycling Mode and Continuous Mode. Choose Cycling Mode.

4. Using the stylus, touch the Cycling ON input box. A pop-up screen appears.

5. Select the range in which the target cycling time appears (Figure 3-25).





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Figure 3-25. Select Target Cycling Time Range

6. Use the sliding bar or arrows to select the exact target cycling time.

7. Select the checkmark ( ) icon to save the settings and exit the pop-up screen.

8. Repeat steps 4 through 7 to set Cycling Off times.

Note: Selecting the exit ( ) icon will return the user to the Special Screen without saving changes.

Cycling Mode can be programmed with or without SoftStart/Stop.

Checkmark Icon

Exit (No Save)Icon





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Notes:

■ If the Cycling On and Cycling Off times for Itrel II or Soletra are programmed to ≥15 seconds, SoftStart is automatically enabled. Conversely, if either the Cycling On or Cycling Off times are <15 seconds, SoftStart will be disabled.

■ Whenever rate, pulse width, or amplitude are adjusted and the neurostimulator is in Cycling Mode, the neurostimulator automatically switches to Continuous Mode for 15 seconds to allow evaluation of the programmed change. At the end of 15 seconds, if no further adjustments have been made, the neurostimulator remains on and a Cycling On period begins.

Day Cycling Feature (Kinetra Only)

The Kinetra Neurostimulator can be programmed with Day Cycling. Day Cycling conserves the neurostimulator battery and is convenient for the patient as a means of synchronizing a therapy schedule with the patient’s 24-hour clock. For example, if a patient requires stimulation while awake and no stimulation while sleeping, the neurostimulator can be programmed to automatically turn on and off at a specified time (Figure 3-26).

Figure 3-26. Day Cycling Mode

The neurostimulator can be manually turned on or off at any time, but the programmed cycling times will not be erased.

24-Hour Clock

Stop Time 2200 (10.00 PM)

Start Time 0730 (7:30 AM)





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Note: Day Cycling may not function properly if the programmer date and time are not accurately programmed.

♦ To program the Day Cycling Feature:

1. Access the Special Screen.

2. In the drop-down box, select Cycling.

3. Using the stylus, touch the Day Cycling input box, Start time (Figure 3-27).

Figure 3-27. Programming Day Cycling

Day Cycling Start

Day CyclingStop





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4. Select the “On” option in the pop-up screen that appears (Figure 3-28).

Figure 3-28. Programming Day Cycling Start and Stop Times

5. Set the start and stop times (available in 30-minute increments) using the sliding bar or arrows.

6. Select the checkmark icon ( ) to set the times or the exit icon ( ) to cancel.

Special Ramp (Itrel II and Soletra)

Special Ramp Stimulation is a cycling mode with a fixed Cycle On Time of 35 seconds and Cycle Off Time of 0.1 seconds. Special Ramp Stimulation works similarly to SoftStart/Stop. However, the ramp time is much longer than in the normal SoftStart/Stop feature. Ramp times of 15, 20, 25, or 30 seconds may be selected. The total Cycle On Time is set to 35 seconds. Thus, the portion of the Cycle On Time at the fully programmed amplitude is 20, 15, 10, or 5 seconds, respectively. The amplitude then immediately drops back to zero for 0.1 seconds before beginning the gradual ramp up to return to the programmed setting.

w Warning: Do not use Special Ramp for deep brain stimulation. Consult the appropriate neurostimulator technical manual for additional information.





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♦ To program Special Ramp:

1. On the Special Screen, select “Other” from the drop-down box (Figure 3-29).

Figure 3-29. Programming Special Ramp Parameters

2. With the stylus, touch the “Special Ramp” input box.

3. Select the ramp time desired.

Note: Programming Special Ramp causes the Cycling Mode to default to Continuous.

Special Ramp Program Function





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Dose/Dose Lockout (Soletra and Itrel II)

Dose and Dose Lockout can be programmed to restrict your patient’s use of the neurostimulator. The Dose parameter represents the time when the patient can turn on the neurostimulator (15, 30, 45, 60, or 75 minutes). The Dose Lockout time represents the time during which your patient cannot turn on the neurostimulator. (1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 hours).

♦ To program Dose and Dose Lockout:

1. On the Special Screen, select “Other” from the drop-down box.

2. With the stylus, touch anywhere in the Dose and/or Dose Lockout input box.

3. Select the time(s) desired for Dose and/or Dose Lockout.

Magnet Amplitude (Itrel II Only)

Magnet amplitude allows the patient to reduce the sensation of stimulation by reducing the amplitude, without a therapy controller. The patient can activate magnet amplitude using a Model 7452 Control Magnet.

Application of the magnet for 1 or 2 seconds followed by immediate removal of the magnet causes stimulation to switch between on and off. Application of the magnet for 6 seconds or more causes the amplitude value to change between normal amplitude and magnet amplitude.

Notes:

■ No programming can be performed when magnet amplitude is active.

■ Use the normal amplitude to find a desired magnet amplitude value.





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♦ To program Magnet Amplitude:


2. Select Other in the drop-down box.

3. Using the stylus, touch the magnet amplitude input box (Figure 3-30).

4. Select the desired amplitude from the list of available amplitude settings.

Figure 3-30. Programming Magnet Amplitude

Magnet Amplitude Input Box





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Rate and Pulse Width Modulation (Soletra and Itrel II)

Rate and pulse width modulation times can be adjusted in an effort to prevent the patient from becoming accustomed to stimulation, thereby limiting its effectiveness. Rate and pulse width modulation are enabled and disabled on the Special Screen.

♦ To program Rate and Pulse Width Modulation:


2. Select “Other” in the drop-down box.

3. Using the stylus, select the rate modulation or pulse width modulation (Figure 3-31) input box and enable or disable the function using the stylus.

Figure 3-31. Setting Rate and Pulse Width Modulation

Note: Figure 3-31 represents an Itrel II.

Rate Modulation Input Box

Pulse WidthModulation

Input Box

Magnet Amplitude Input Box





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Control Magnet

The control magnet allows your patient to turn the neurostimulator output on and off.

♦ To enable and disable the Control Magnet (Kinetra):


2. Select “Other.”

3. Using the stylus, touch the control magnet input box (Figure 3-32).

Figure 3-32. Enabling and Disabling the Control Magnet

4. The control magnet function toggles between on and off.

Control Magnet Input Box

ProgrammingUsing the Data Screen




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Using the Data Screen

Overview

Neurostimulation Systems provide several measurement functions that are useful when you are assessing:

■ Status of the neurostimulator battery;

■ System troubleshooting;

■ Patient use of the device.

Table 3-3. Measurement Functions

Measurement Functiona What it Does When to Use

Battery Information (refer to Data Screen)

• Provides a general indication of the status of the neurostimulator battery [OK, Low, or EOL (End of Life)]

• Provides reading of battery voltage

After each programming session or for troubleshooting

“Stim” Current (refer to Data Screen)

Measures current present within the system

After each programming session or for troubleshooting

“Stim” Impedance (refer to Data Screen)

Measures impedance within the system (resistance of the lead, extension, and body tissue to stimulation)

After each programming session

Patient Use Data (refer to Quick Look Screen)

Reports patient’s use of the neurostimulator

During each patient follow-up

Automated Impedance Measures each electrode pair to test all wires in the lead

For troubleshooting

Battery Capacity Calculates the percentage of battery that has been used

During each patient follow-up

a Note: Not all neurostimulators support all functions.





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Recommendations When Using Measurement Functions

Measurements and diagnostic data obtained from the N’Vision Clinician Programmer are intended to aid in your clinical observations. If a patient is receiving unsatisfactory stimulation, measurement of electrode impedance may help detect problems with the system, such as a broken lead, loose connection, or short circuit.

However, as with any electronic system, internal and external factors can influence the accuracy of neurostimulator measurements. For example, changes in lead position can affect the stimulation current or the load impedance measurement. If you obtain a reading that seems inconsistent with your observations, repeat the measurement.

Before using any measurement functions, please note:

■ In general, more accurate readings can be obtained at the measurement default or at higher amplitude and/or pulse width settings. Under some conditions, such as low amplitudes or narrow pulse widths, a measurement cannot be obtained.

■ You should measure electrode impedance at the end of each programming session. This provides historical information that may be useful for troubleshooting and isolating problems if they arise. For example, measurements that show a significant increase in load impedance can indicate a fractured lead conductor, a loose setscrew, etc. Conversely, a significant decrease in load impedance can indicate shorted conductors, a break in lead insulation, etc. For the purposes of troubleshooting, it is useful to know what the measured values were when the system was operating properly.

# Caution: DO NOT rely solely on the results of impedance testing for troubleshooting. Accuracy of the data generated during impedance tests can fluctuate based on the neurostimulator that is being tested and on the programmed settings.





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Data Screen Components

The Data Screen consists of three areas representing different types of diagnostic data that can be collected (Figure 3-33).

Figure 3-33. Data Screen Components

Electrode Impedance Measurements

Therapy Measurements

Neurostimulator Battery Measurements





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Electrode Impedance – If a patient is receiving unsatisfactory stimulation, measurement of electrode impedance might help detect problems with the system, such as a broken lead, loose connection, or short circuit. Refer to the Troubleshooting section of this programming guide for additional information.

Note: The impedance measurement is an automated feature that delivers a short sequence of pulses to each possible electrode pair, one after another. This can potentially cause transient unexpected effects. The measurement can be stopped at any time using the Therapy-Stop key or on-screen cancel button. All measurements recorded prior to selection of the Therapy-Stop key or cancel button will be displayed on the programmer screen.

Default amplitude (1.5 volts), pulse width (210 μsec), and rate (30 Hz) settings are available for use during electrode impedance measurement. Typically the lowest settings possible to successfully complete the test should be used for Kinetra. During the test, the measurement settings replace the settings you have programmed. At the end of the test, programmed settings are automatically restored. Refer to “Troubleshooting” on page 4-1, for more information.

To measure electrode impedance, use the stylus to select the measurement icon ( ) WHILE THE PROGRAMMING HEAD IS POSITIONED OVER THE NEUROSTIMULATOR. When the test is complete, test results will display on the screen.

After you select the measurement icon to begin the test, a pop-up message will display, asking you to choose to continue or cancel the test. If you choose to continue, the test will begin, and a status bar will be displayed, allowing you to track the progress of the test. This second window will also contain a cancel test option that can be selected at any time during the test.

Note: Many electrode combinations are tested, and the test may last up to 2 minutes. If the electrode impedance test is interrupted due to interference or telemetry loss for other reasons before completion, the neurostimulator will remain programmed with the parameters used during the test. Review the Troubleshooting section of this manual for potential causes of telemetry loss, take appropriate corrective action, and select Retry. Check the final programmed parameters in the neurostimulator.





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If at any time you select the “Cancel” button, the programmer will automatically return stimulation parameters to the most recently programmed values. The Therapy Stop key will also interrupt the test, but the neurostimulator will be turned off before stimulation parameters are restored to the values programmed prior to initiation of the test.

Therapy Measurements – The therapy measurements area provides for impedance and stimulation current measurements at the currently programmed (actual) device parameters.

You may need to increase parameters to ensure an effective test, or decrease parameters to avoid patient discomfort.

To measure these parameters, use the stylus to select the measurement icon ( ) WHILE THE PROGRAMMING HEAD IS POSITIONED OVER THE NEUROSTIMULATOR. When the test is complete, test results will display on the screen.

Battery Information – The battery information area provides neurostimulator battery status information. The battery status is updated each time the neurostimulator is programmed and each time the battery status is reviewed. One of the following messages will display to describe the status of the neurostimulator battery:

■ OK

■ Low (Battery voltage is 5–15% of original capacity)

■ EOL (End of life; less than 5% of original capacity remains)

After the neurostimulator battery is depleted, therapy and telemetry are no longer possible.

To measure voltage and battery capacity, use the stylus to select the measurement icon ( ) WHILE THE PROGRAMMING HEAD IS POSITIONED OVER THE NEUROSTIMULATOR. When the test is complete, test results will display on the screen.

ProgrammingProgramming a Neurostimulator for Patient Control




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Programming a Neurostimulator for Patient Control

For the Kinetra Neurostimulator, you have the option to prescribe upper and lower limits for amplitude, pulse width, and rate that allow your patients to adjust their stimulation within your prescribed limits using the therapy controller. The Kinetra Neurostimulator is shipped with these optional limits set to ±0. To enable these optional limits, program the limits to the appropriate values for your patient.

Patient selection – Adjustable parameter control may not be appropriate for all patients. Physician discretion will need to be exercised to determine whether an individual patient and/or caregiver is capable of managing parameter control that adjusts therapy. Patients may be eligible for adjustable parameter control if they:

■ do not exhibit symptoms of dementia.

■ have the cognitive ability to understand and operate the therapy controller.

■ have the physical ability to operate the therapy controller (or the patient’s caregiver is physically able to operate it).

■ may benefit from having the ability to adjust parameters.

■ have the ability and willingness to maintain contact with the programming clinician.





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Programming recommendations – If you decide to give your patient adjustable parameter control, please note the following recommendations:

■ Give only amplitude control to patients who have never adjusted their stimulation before.

■ Use a step approach when allowing additional parameter control. Give your patient control of one additional parameter at a time.

■ Program limits to allow the patient or caregiver to easily return to the programmed therapeutic baseline when needed (see step 1 in “Programming Patient Limits” on page 3-62). The therapeutic baseline is the clinician-programmed value for amplitude, pulse width, or rate.

■ Always check the programmed changes prior to the patient leaving the office.

■ Schedule follow-up visits with the patient. Giving the patient adjustable parameter control is not intended to replace follow-up visits.

The Therapy Controller and Limits

The user manual patients receive with their Model 7436 therapy controller explains that patients adjust a stimulation parameter by pressing the Increase or Decrease key for the selected program. For each successful adjustment (increase or decrease) of a stimulation parameter the therapy controller beeps once. Three beeps indicate the patient has tried to adjust a stimulation parameter beyond the programmed limit.

Number and size of adjustments – Explain to your patients how many adjustments it takes to reach their upper limit and lower limit from their programmed baseline for each parameter. In programming patient control limits, the number of patient adjustments for a parameter equals the number of programmable values between the limit value and programmed value. See the table below for the programmable values for each stimulation parameter.





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Patient Limits

There are two programmable options for both lower and upper limits: custom limits and tracking limits.

Custom Limits

Custom limits are higher and lower values independent of the programmed values. The upper custom limit cannot be programmed to a value less than the programmed value for the parameter (Figure 3-34).

Figure 3-34. Example of Physician Programmed Custom Limits

Table 3-4. Stimulation Parameter Values

Stimulation Parameters Values

Amplitude Normal resolution: 0 to 10.5 V in 0.1 V stepsFine resolution: 0 to 6.35 V in 0.5 V steps

Pulse Width 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450 µsec

Rate 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 102, 105, 107, 110, 115, 117, 120, 125, 127, 130, 132, 135, 137, 140, 142, 145, 147, 150, 152, 155, 157, 160, 165, 167, 170, 175, 180, 182, 185, 190, 195, 200, 205, 210, 215, 220, 230, 235, 240, 250 pps

Volts

1

2

3

4

Patient's Range of

Stimulation

Physician Programmed Value

Physician Programmed Lower & Upper Limits





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Notes:

■ You must always evaluate both upper and lower custom limits with any change to programmed values.

■ If you program a value for amplitude, pulse width, or rate above or below the programmed custom upper and lower limit values, the programmer will adjust the custom value to equal the programmed value.

Caution: Custom limits (if used) should always be set as a final step in programming, prior to printing a final review. The limits often change when using the physician programmer to program new settings for amplitude, amplitude resolution, pulse width, or rate. By programming custom limits last, you ensure accuracy and save time otherwise required to reprogram.

Tracking Limits

Tracking limits automatically remain at a specified value above and below the programmed value for amplitude (±0V, ±0.4V, ±1V, ±2V, ±3V), pulse width (±0µs), and rate (±0Hz). Upper limits and lower limits change when the programmed value for amplitude, pulse width, and/or rate are changed with the clinician programmer. For example, if the limit for amplitude is set to track at ±1V, then the upper limit will always remain 1V greater than the programmed amplitude value (up to the maximum allowable parameter). Similarly, the lower limit will be 1V less than the programmed amplitude value (down to 0V), no matter how often amplitude is changed with the clinician programmer (Figure 3-35).

Figure 3-35. Example of Physician Programmed Tracking Limits

+1V

+1V –1V

–1V

Patient's Range of

StimulationPatient's Range of

Stimulation

Physician Programmed Value

Physician Programmed Lower & Upper Limits

Volts

1

2

3

4





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Programming Restrictions

■ Program 1 and Program 2 must be set to the same programmable option, either custom limits or tracking limits.

■ If both programs carry tracking limits, the tracking values will be the same for both programs.

■ If both programs carry custom limits, the limit values may be different for each program.

■ If the parameter limit for the selected program is switched from a tracking limit to a custom limit, the parameter limit for the other program will also change to a custom limit. The new limit is set by adding the programmed parameter for the unselected program to the previous Tracking Limit value.

■ If the upper limit for amplitude or pulse width is programmed to a higher value than the programmed value, the physician programmer will use the higher value when calculating charge density.

■ When you are programming patient control limits, the physician programmer will warn you if the combination of programmed parameters plus the patient control limits exceed the safe charge density values. You should not override this charge density warning when programming patient limits. Reduce the allowed programmability so that the maximum settings that the patient could program do not exceed the safe charge density values. The patient does not receive the charge density warning.





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Programming Patient Limits

Note: When programming patient limits, take into consideration the patient’s use of medications.

♦ Procedure – To program limits

1. Select the Patient Control option on the Special Screen (Figure 3-36).

Figure 3-36. Programming Patient Control Parameters

Note: When programming patient limits, ensure that patients can return to their therapeutic baseline by programming one of the following options:■ Set the lower limit to the baseline value so patients can only

increase their stimulation but can return to their baseline by simply decreasing stimulation.

■ Set the upper limit to the baseline value so patients can only decrease their stimulation but can return to their baseline by simply increasing stimulation.

■ Set the lower and upper limits as desired around the baseline. Inform patients of the number of steps between the therapeutic baseline and the upper and lower limits (See “Number and size of adjustments” on page 3-58).

2. To program custom or tracking limits for amplitude, select the arrow in the drop-down box.





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3. Select either Custom or the tracking value desired in the drop-down box.

4. If you are using two programs, select the input box corresponding with the appropriate program.

5. If you selected custom, a list of available limits will appear. Enter the target value, and repeat for the other side. For tracking limits, select the desired value from the available choices.

Notes:■ For patients who have never adjusted their stimulation before, it

is recommended that you provide only amplitude control (go to step 10 to finish the procedure).

■ If you decide to give your patient additional parameter control, use a step approach and give only one additional parameter at a time.

6. In the pulse width box, select the arrow on the drop-down box.

7. For pulse width custom limits, select custom. Using the stylus, select the input box corresponding to the program you are using. A pop-up screen will appear; select the target value. Repeat for second program if appropriate. For tracking limits, select ±0 µsec. Select Program.

Note: Selecting ±0 for tracking limits will prevent your patient from changing pulse width parameters.

8. In the rate box, select the arrow on the drop down box.

9. For rate custom limits, select custom. Using the stylus, select the input box corresponding to the program you are using. A pop-up screen will appear; select the target value. For tracking limits, select ±0Hz. Select Program. Rate is not independently programmable for both programs.

Note: Selecting ±0 for tracking limits will prevent your patient from changing rate parameters.

10. When you have set all patient control target values, hold the programming head over the implanted neurostimulator. Press the program (P) button and hold the programming head in place until telemetry is complete.





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11. After setting the patient control limits, program the neurostimulator to the minimum and maximum amplitude, rate, and pulse width combinations to assure that each combination does not cause any undesired side effects.

Note: When testing patient limits, take into consideration the patient’s use of medications as they may affect the patient’s overall therapy outcomes.

12. Prior to the patient leaving the clinic: ■ Explain to the patient or caregiver how to adjust stimulation

parameters with the therapy controller, including how programmable limits affect parameter adjustment. Inform patients how to return to their therapeutic baseline (see step 1 in “Programming Patient Limits” on page 3-62).

■ Tell the patient or caregiver which side of his or her body is controlled by the Program 1 Increase/Decrease keys and which side corresponds to the Program 2 Increase/Decrease keys on the therapy controller. Record this information in the program record section of the Access Model 7436 Therapy Controller patient manual.

■ Have the patient or caregiver use the therapy controller to demonstrate that he or she has the ability to implement therapy changes and return to the programmed therapeutic baseline.

■ Instruct the patient or caregiver to return to therapeutic baseline settings or turn the device off and call the prescribing physician if changing stimulation values results in uncomfortable stimulation or other unwanted effects.

■ Remind the patient or caregiver to schedule follow-up visits with the prescribing clinic.

ProgrammingReviewing and Printing from the Summary Screen




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Reviewing and Printing from the Summary Screen

The Summary Screen should be reviewed prior to ending the patient session.

After the completion of a programming session, the programmed settings should be reviewed, printed, and placed in the patient file for future reference. The N’Vision Clinician Programmer contains an infrared (IR) port for communication with most IR capable printers. You can order an IR-compatible Model 3445 Seiko DPU printer through Medtronic. Brief directions for printing are presented below. For detailed information on printer selection and printing, refer to the technical manual packaged with the N’Vision Programmer.

From the Summary Screen, all programming changes made during the patient session can be canceled by using the Return to Initial Settings option (Figure 3-37).





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Figure 3-37. Return to Initial Setting

When the Return to Initial Settings option is selected, a pop-up screen displays, asking the user to confirm the choice to cancel all programming changes made during the session.





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♦ To print a copy of the currently programmed settings:

Note: You must exit the application before a report on that session can be saved and accessed for printing in the Session Data Manager.

1. Move the N’Vision Programmer to within 1 meter of the desired printer. Ensure that the IR port on the programmer and the IR port on the printer are directly facing each other.

2. On the Summary Screen, select “Print Report” (Figure 3-38).

Figure 3-38. Accessing the Print Function

3. A message screen will appear, giving you the option to print or cancel the print request. Select the appropriate option. The report will print automatically unless you press cancel.

Note: The print function can also be accessed at any time by selecting the printer icon ( ) at the top of any of the programmer screens, or by selecting the Session Data Manager ( ) icon from the Slider Bar. Figure 3-39 shows the print request screen and its options.

During the patient session, the initial and final programmed parameters are automatically saved to a unique report. The name of the report and that of the patient session are identical, and reports are automatically saved to the Session Data Manager.

Print Report Field





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Figure 3-39. Print Request Screen

Print a “long” report of selected session

Print a “short”report of selected

session

Move highlighted jobs out of print queue

Printer queue





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To print from the Print Request Screen

1. Select the printer icon from the Slider Bar or from the Application Bar at the top of the programmer screen.

2. A list of patient sessions will be displayed in the lower half of the Session Data Manager. Highlight the patient session(s) you wish to print.

3. Move the highlighted patient session(s) to the printer queue by selecting either the print long report (includes therapy measurement data) or print short report (includes patient information and programmed settings data) option (Figure 3-39).

4. The programmer IR protocol is enabled as soon as you move the patient session(s) into the printer queue. Align the programmer IR port with an IR port on a compatible printer, and the reports will automatically print.

To delete patient sessions from the Session Data Manager, highlight the patient session(s) you wish to delete, and use the stylus to select the trash can icon on the lower right corner of the screen.





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4Troubleshooting

This section contains troubleshooting information for the most common stimulation problems. The purpose of this section is to guide and direct the clinician if problems arise during programming of Kinetra, Soletra, or Itrel II Neurostimulators. Approach troubleshooting conservatively. Prior to performing invasive procedures, ensure that all non-invasive causes have been considered, and contact a Medtronic representative.

No Telemetry or Error Messages 4-3

No Stimulation or Intermittent Stimulation 4-10

Changes in Symptom Suppression 4-18

Ineffective Stimulation 4-19

Troubleshooting




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Table 4-1. Troubleshooting logic for common stimulation complications

PROBLEM SOLUTION

Noninvasive Procedures

Invasive Procedures

No Telemetry or Error Message

• Refer to No Telemetry Checklist on page 4-4

Problem unresolved?

Perform Actions in Table 4-2, page 4-5.

No Stimulation or Intermittent Stimulation (Refer to page 4-10 for possible causes.)

• Perform Procedure 1 (page 4-10) for non-invasive troubleshooting

Problemunresolved?

Perform Procedure 2 (page 4-14) for invasive troubleshooting

Changes in Therapy (Refer to page 4-18 for possible causes.)

• Perform Procedure 3 (page 4-18) for non-invasive troubleshooting

Problemunresolved?

Perform Procedure 4 (page 4-18) for invasive troubleshooting

Ineffective Stimulation (Refer to page 4-19 for patient-related and etiology-related causes.)

• Patient-related causes: Perform Procedure 5 (page 4-19) for non-invasive troubleshooting

TroubleshootingNo Telemetry or Error Messages




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No Telemetry or Error Messages

During telemetry, the following message box will be displayed:

Telemetry problems are identified on the programmer in the following format:





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The messages that appear during telemetry failure include:

■ The telemetry module is not responding

■ There was no response from the neurostimulator

■ There was interference during attempted communication with the neurostimulator

The most common causes for no telemetry are listed below. Check this list prior to proceeding to Table 4-2. Refer to Table 4-2 for additional error message troubleshooting.

No Telemetry Checklist

■ Decrease the distance between the telemetry module and the neurostimulator, pressing the module firmly over the implanted neurostimulator.

■ If unsure of the exact location of the neurostimulator, place the telemetry module in several different positions around the approximate location of the neurostimulator.

■ After pressing the Programming key, move the programming head around slowly near the implant.

■ Look for the indicator light on the back of the telemetry module. Successful telemetry is confirmed by a flashing green light.

■ When holding the telemetry module over the implanted neurostimulator, do not drape your hand over the back of the module. Hold the module at the base.

■ Ensure that the programmer batteries are not depleted.

■ Check for sources of possible EMI interference (e.g., computer monitors).

Noninvasive Troubleshooting for No Telemetry or Other Error Messages

Note: Before referring to Table 4-2, ensure that you have gone through the “No Telemetry Checklist” presented above.





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Table 4-2. Noninvasive Troubleshooting for No Telemetry, Error, or Informational Messages

ERROR MESSAGE/TEXT EXPLANATION

TELEMETRY FAILURE.There was no response from the Implantable Neurostimulator. Reposition the programming head and press Retry. Press Cancel to end this session.

The neurostimulator did not respond.

TELEMETRY FAILURE.There was interference while communicating with the Implantable Neurostimulator. Reposition the programming head or move away from potential sources of interference and press Retry. Press Cancel to end this session.

Interference occurred during communication with the neurostimulator.

NEW INS DETECTED.A different Implantable Neurostimulator has been detected. Reposition the programming head over the original device and press Retry. Press Cancel to quit this session.

A new neurostimulator was detected.

BATTERY WARNING.The programmer batteries are low. Turn the programmer off and replace the batteries.

Battery is low.

CARD MISSING.The Application Card has been ejected. Reinsert the card to continue.

Application card was ejected.

CARD FAILURE.The Application Card has been corrupted. Power down the programmer and contact Medtronic technical services.

Application card error.

SESSION DATA MANAGER.The Session Data Manager is full. Press the Continue button to proceed without saving this session. Press Cancel to open the Session Data Manager and delete old records.

The Session Data Manager is full.

APPLICATION CARD FULL.The Application Card is full. Files for this session will not be saved. Consult the technical manual.

The application card is full; patient information will not be saved.





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APPLICATION ERROR.The application has been halted because of an error. Contact Medtronic technical services: Service Code: _________________

The application has stopped because of an internal error.

INVALID INS SETTING.Invalid parameters have been detected in the Implantable Neurostimulator. Press Continue to program the device to valid settings.

Invalid parameters have been detected in the neurostimulator.

POWER ON RESET.The Implantable Neurostimulator has undergone a reset. Refer to the technical manual. Reenter the serial number and press Continue. If you do not know the serial number of the device, press Cancel.

The neurostimulator has undergone a power on reset.

INVALID SERIAL NUMBER.An invalid serial number has been detected. Reenter the serial number and press Continue. If you do not know the serial number of the device, press Cancel.

The serial number at session start was invalid.

MAGNET PRESENT.The programming head has detected a magnet. Remove the magnet to continue.

A magnet was detected on the telemetry module.

MAGNET MODE.The Implantable Neurostimulator is in magnet amplitude mode. This mode must be disabled in order for the normal amplitude to be active.

The neurostimulator is in magnet amplitude (“mag amp”) mode.

INVALID ELECTRODE.Electrode configuration must include at least one positive (+) and one negative (-) electrode.

An invalid electrode setting exists

INVALID ELECTRODE.The Case is positive (+). No other electrodes can be positive (+).

An invalid electrode setting exists.

INCOMPLETE MEASUREMENT. The measurement for one of the programs cannot be made because all electrodes are off.

Impedance and therapy measurements cannot be made because no electrodes have been programmed.

Table 4-2. Noninvasive Troubleshooting for No Telemetry, Error, or Informational Messages (Continued)






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CLEAR COUNTERS. Reset therapy counters?

You have selected the clear counters option.

AUTOMATED IMPEDANCE. This test will take approximately 1 to 2 minutes. All electrode pairs will be tested. Consult the technical manual for important patient information.

You have selected the automated impedance test function.

PROGRAM CHANGE. Changing the number of programs will cause all amplitude settings to be set to 0. Do you wish to proceed?

You have chosen the option to change the number of programs to use for the patient’s therapy.

CONFIRM MEASUREMENT. The device’s output will be temporarily turned off during this measurement. Do you wish to proceed?

You have chosen to run a test that will temporarily turn off all stimulation parameters.

INITIAL SETTINGS. This will reset all parameters to the values that they had at the beginning of the current session. Do you wish to proceed?

You have selected the return to initial settings function.

UNCONFIRMED VALUES. Unconfirmed parameter values exist. Start a new session and verify all parameters.

The programmer cannot confirm the most recently programmed values.

CONFIRM MEASUREMENT. The device’s output will be temporarily turned on during this measurement. Do you wish to proceed?

You have chosen to run a measurement test during which stimulation parameters will be turned on.

LIMITS HAVE CHANGED. Caution: One or more parameter limits have changed.

The programmer has detected changed limits.

INS NOT SUPPORTED. This Application does not support the detected device. Refer to the technical manual for a listing of supported devices. Press Ok to end this session.

The implanted neurostimulator cannot be programmed by the clinician programmer.

DOSE LOCKOUT. The Implantable Neurostimulator cannot be turned on while Dose Lockout is in effect.

You selected the neurostimulator “On” function while dose lockout was programmed on.







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DOSE LOCKOUT. Dose Lockout is programmed. Refer to the technical manual for details of this feature.

The selected parameter cannot be activated when dose lockout is on.

PARAMETERS HAVE CHANGED. Parameters have been changed by another programmer. Check the new parameter values.

Stimulation parameters have been reprogrammed during a session with a different programmer.

INCOMPLETE MEASUREMENT. The measurement cannot be made at these settings. Reprogram pulse width or amplitude to a higher value and try again.

Amplitude or pulse width settings are too low for a successful impedance therapy measurement.

TELEMETRY IN PROGRESS.Communicating with the Implantable Neurostimulator.

The programmer is attempting device interrogation.

WARNING.Do not use special ramp for deep brain stimulation. Consult the technical manual.

You have attempted to program special ramp with deep brain stimulation therapy.

WARNING.Charge density may be high enough to cause tissue damage. Consult the technical manual.

You have selected an amplitude or pulse width setting that may be great enough to cause tissue damage.

WARNING.Do not use cycling mode for deep brain stimulation. Consult the technical manual.

You have attempted to program cycling mode with deep brain stimulation therapy.







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Figure 4-1. Iconic Error Messages

Hardware/Software Failure Message

Application Card Missing Application Card Error

Therapy-stop Key Pressed with no Application Active

Programming Key Pressed with no Application Active

TroubleshootingNo Stimulation or Intermittent Stimulation




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No Stimulation or Intermittent Stimulation

No stimulation or intermittent stimulation may be caused by any of the sources listed below. If you suspect one of these problems, perform Procedure 1.

Causes of No Stimulation or Intermittent Stimulation

■ The patient is confused about the use of the therapy controller or control magnet.

■ The patient has turned off the neurostimulator.

■ Amplitude is too low to be effective.

■ Stimulation is in the Cycling Mode (Cycling Off Time).

■ There is a short circuit or open circuit in the lead or extension.

■ The metal of the conductor wire or connection mechanism is exposed or uninsulated.

■ The wound dressing is too thick to allow for successful telemetry.

■ There is a connection problem (lead to extension or neurostimulator to extension).

■ The neurostimulator battery is depleted.

■ Neurostimulator component failure.

■ The patient has come into contact with a magnet (telephone head, refrigerator door, stereo speakers, etc.) and the neurostimulator has turned off and on.

■ The neurostimulator is in Dose Lockout Mode (Soletra and Itrel II).

♦ Procedure 1 – Noninvasive troubleshooting for no stimulation or intermittent stimulation

1. Ask the patient to describe the stimulation problem using the following questions:

Did the loss of stimulation occur suddenly or gradually?■ Sudden loss of stimulation may indicate that the

neurostimulator has been turned off or that there is a hardware problem.





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■ Gradual loss of stimulation may indicate battery depletion or a physiologic cause such as sensory accommodation.

Describe the feeling of stimulation that you are experiencing at this time.

Note: Encourage the patient to accurately and completely describe the feeling of stimulation.■ No feeling may indicate a hardware problem, battery depletion,

or a physiologic cause as described above.■ A burning sensation, somewhere along the system pathway

from the neurostimulator to the lead, that comes and goes when the neurostimulator is turned on and off may indicate a problem with leads, extensions, or connectors.

■ A burning sensation that is constant may indicate a physiologic cause such as infection.

■ A change in the therapy results may indicate lead migration.■ In a unipolar configuration (case is positive) the patient may

experience skeletal muscle stimulation around the site of the neurostimulator, particularly at high amplitude settings. Consider using bipolar configurations when possible to resolve skeletal muscle stimulation.

2. If the source of the problem is revealed in Step 1, perform the relevant test listed below and resolve the problem. Otherwise, perform the following tests in succession until the problem is uncovered or resolved.■ Programming Review■ Battery Depletion Check■ Electrode Impedance and Stimulation Current Measurements■ Component Palpation■ X-ray Examination

Programming Review

1. Ensure the patient is using the device(s) correctly.

2. Review all program settings, electrode selections, parameters, and modes to ensure that all settings are correctly programmed.

3. Set stimulation to the continuous mode and eliminate the SoftStart/Stop feature while ensuring that the neurostimulator is on.





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4. Slowly increase the amplitude to determine therapy response. In some cases, the patient has simply “accommodated” to a certain voltage level and may require a slight increase to obtain adequate control.

Battery Depletion Check

Battery depletion is one potential cause of system problems, particularly with a neurostimulator. Check the neurostimulator battery status. Refer to page 3-52 of this programming guide and the appropriate neurostimulator technical manual for additional information.

Component Palpation

1. Turn the amplitude to the previously programmed, comfortable voltage level.

2. Try a palpation test to further interrogate the system:

a. Firmly palpate or massage the skin over the implanted system components, beginning at the neurostimulator pocket.

b. Continue to palpate the skin along the pathway to the lead-extension connection near the neck, ensuring that all components and connections are firmly palpated.

c. Watch for these results:■ Stimulation recurs when implanted components are palpated,

indicating a possible loose connection that must be surgically repaired (refer to Procedure 2).

■ Patient feels a burning sensation, particularly at a connection or along the extension pathway, indicating a possible exposed wire or connection that must be surgically repaired (refer to Procedure 2).

Note: If the burning sensation continues when the neurostimulator is off, a physiologic cause, such as infection, may be the cause.

X-ray Examination

Obtain an x-ray to investigate lead position, loose connections, and possible broken wires.

■ Because an x-ray detects metal, a continuous path of metal should be seen from the neurostimulator to the stimulating electrodes.





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■ An opening or “blank spot” in the path may indicate a broken wire or an open connection.

Note: Lack of visualization of the extension metal conductor might not indicate a discontinuity. Contact Medtronic for more information.

■ Confirm that no connections have been pulled apart.

Lead migration, loose connections, and broken lead wires all require surgical intervention (refer to Procedure 2).

Electrode Impedance and Stimulation Current Measurements for the Soletra and Itrel II Neurostimulators

Electrode impedance and stimulation current are electrical values that can be interrogated with the programmer. These values may help to further define the system problem.

Look for the expected measurement values for short circuit (low impedance, high stimulation current) or open circuit (high impedance, low stimulation current):

Electrode Impedance and Stimulation Current Measurements for the Kinetra Neurostimulator

Electrode impedance and stimulation current are electrical values that can be interrogated with the programmer. These values may help to further define the system problem.

Look for the expected measurement values for short circuit (low impedance, high stimulation current) or open circuit (high impedance, low stimulation current):

Impedance values indicating potential short circuit

Soletra Neurostimulation System Itrel II Neurostimulation System

Impedance<100 Ohms Impedance<100 Ohms

Impedance values indicating potential open circuit

Impedance>2000 Ohms Impedance>2000 Ohms

Impedance values indicating potential short circuit

Impedance values indicating potential open circuit

Impedance<100 Ohms Impedance>4000 Ohms





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Accuracy of impedance measurement for the Model 7428 Kinetra Neurostimulator – At typical stimulation settings for Parkinson’s disease patients (1-3.5 V, 60-120 µsec), the impedance measurement may not accurately reflect the actual lead impedance. In general, the accuracy of the impedance measurement increases at higher amplitudes and wider pulse widths. Refer to Table 4-3 for a listing of stimulation parameter settings, measured impedance, and corresponding actual impedance.

# Caution: DO NOT rely solely on the results of impedance testing for troubleshooting. Accuracy of the data generated during impedance tests can fluctuate based on the neurostimulator that is being tested and on the programmed settings.

♦ Procedure 2 - Invasive troubleshooting for no stimulation or intermittent stimulation

If none of the noninvasive troubleshooting tests have identified the problem or if these tests have demonstrated that the problem is with an implanted component, contact Medtronic Technical Services for additional information before proceeding with the invasive procedure (surgery).

Supplies needed for invasive troubleshooting include the following:

■ Alligator clip cable

■ Test Stimulation (Screener)

■ Backup system components (lead, extension, neurostimulator)

Table 4-3. Accuracy of Load Impedance Measurement a

Stimulation Parameter Settings (Amplitude and Pulse Width)

Measured Impedance (Ohm) Actual Impedance (Ohm)

1 V, 60 µsec 0-200200-400

400-4000

0-700700-2000

2000-Open

3 V, 120 µsec 0-500500-10001000-20002000-4000

0-500500-1400

1400-40004000-Open

4 V, 210 µsec 0-500500-10001000-16001600-24002400-4000

0-500500-1000

1000-19001900-34003400-Open

a All values are approximate.





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■ Programmer

■ Accessories (hex wrenches, boots, medical adhesive, stylets, anchors)

■ Other supplies as needed

Note: All supplies must be sterile except the test stimulator and programmer.

If you have identified specific component problems, perform the corresponding troubleshooting procedure from the following:

■ Exposed wire or connection

■ Connection problem

■ Lead migration

Exposed Wire or Connection

If the patient presents with a “burning” sensation that is only present when the neurostimulator is on, perform the initial surgical incision over the site of the reported burning. Be careful not to damage any insulation.

Note: A constant burning that continues when the neurostimulator is off may indicate a physiologic cause such as infection.

If the burning is at a connection site, redo the connection using a new insulation boot, then:

■ Inspect for lead full insertion into the extension connector.

■ Inspect connection for any damage.

■ Inspect setscrews for proper tightness.

■ Place the newly redone connection back into the incision and retest the system prior to wound closure.

If the burning is at the neurostimulator site, be certain that:

■ The etched identification side of the neurostimulator is facing towards the skin, not towards the muscle.

■ The rubber grommets remain in all four screw holes on the neurostimulator connector block and that no leaf within a rubber grommet is stuck open.





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■ The extension is fully seated in the connector block and that there are no nicks or cuts on the underside of the neurostimulator or anywhere that might result in bare metal exposure.

Note: If the rubber grommets appear to be damaged or open to fluid infiltration, use a small amount of medical adhesive on the surface to seal. Do not force adhesive into the setscrews.

Connection Problem

If there is a connection problem, perform the surgical incision over the connection site. Redo connection, testing for system integrity prior to wound closure.

Note: Do not overtighten connections. Tighten each setscrew clockwise until it touches the extension connector pin—continue tightening for a maximum of 1/4 turn only. After you remove the hex wrench, check that the rubber grommet has closed.

Lead Migration

If the lead has migrated, perform the incision over the lead-extension connection.

1. Expose and bring the connection outside the incision. Disconnect the lead extension.

2. If the lead is anchored, carefully dissect down to the anchoring site and remove the anchor.

3. Attempt to guide the lead to a location that yields appropriate therapy response. Conduct screening tests to confirm proper lead location.

4. Carefully redo the lead-extension connection, internalize the system, and close the wound.

If you have not identified specific component problems, perform the troubleshooting procedure below.

1. Position the patient on the operating table so that the lead-extension site and neurostimulator pocket are accessible.

2. Identify the lead-extension connection by palpation or fluoroscopy and perform an incision to expose the connection, being careful not to damage the system components with the scalpel. Carefully bring the connection outside the incision.





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3. Remove the protective boot from the connection, undo the connection and separate the lead and extension.

4. Connect the screening cable to the lead. Connect the screening cable to the test stimulator and screen the patient to determine the electrode combination last used by the patient.

a. If stimulation occurs, proceed to step 5.

b. If stimulation does not occur, the lead may need to be replaced or repositioned.

5. Reconnect the lead and extension and turn the system on.

a. If stimulation occurs, put the protective boot back on and carefully redo the connection, retesting prior to internalizing the system.

b. If stimulation does not occur, proceed with step 6.

6. Perform an incision and bring the neurostimulator outside. Exercise extreme care with the scalpel to avoid damaging the components. Undo the extension-neurostimulator connection and separate the components. Attach the alligator clip screening cable to the end of the extension. Connect the cable to the test stimulator and test the patient for stimulation response.

a. If stimulation occurs, proceed with step 7.

b. If stimulation does not occur, the problem may be with the extension. Replace it with a new extension. Reconnect system components and screen prior to internalization.

7. Reconnect the neurostimulator to the extension. Turn the neurostimulator on.

a. If stimulation occurs, inspect the connection to ensure that it is secure and carefully place the neurostimulator back in the pocket. Turn the neurostimulator on once more and verify system integrity prior to wound closure.

b. If stimulation does not occur, contact a Medtronic representative. For possible causes of no stimulation, refer to page 4-10.

TroubleshootingChanges in Symptom Suppression




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Changes in Symptom Suppression

Changes in symptom suppression may be caused by any of the sources listed below. If you suspect one of these problems, perform Procedure 3.

Causes of Change in Therapy Response

■ There is lead migration.

■ There is a short or open circuit resulting in reduced current delivered to the stimulating electrodes.

■ There is medication interference.

♦ Procedure 3 – Noninvasive troubleshooting for change in therapy response

1. Try different electrode combinations. Be certain to have at least one electrode negative and one electrode positive.

2. Palpate along the extension-lead connection; the patient should feel a change in stimulation if there is an insulation break or a loose connection. If found, an insulation break or loose connection must be invasively repaired.

3. Obtain an x-ray to determine if the lead has migrated.

4. If the patient feels a burning in the neurostimulator pocket, there may be a short or open circuit (e.g., exposed wire). Short or open circuits must be invasively repaired. Refer to Procedure 4.

♦ Procedure 4 – Invasive troubleshooting for change in therapy response

If none of the noninvasive troubleshooting tests are able to recapture appropriate stimulation, contact Medtronic Technical Services for additional information before proceeding with the invasive procedure (surgery).

1. Make an incision at the lead-extension connection. Expose and bring the connection outside the incision. Disconnect the lead and extension.

2. If the lead is anchored, carefully dissect down to the anchoring site and remove the anchor.

TroubleshootingIneffective Stimulation




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3. Attempt to guide the lead to a location that yields appropriate therapy response. Conduct screening tests to confirm proper lead location.

4. Carefully redo the lead-extension connection, internalize the system, and close the wound.

Ineffective Stimulation

Ineffective stimulation (i.e., stimulation that is in the appropriate areas, but not strong enough to meet therapy needs) may be caused by patient-related or etiology-related causes as described below. If you suspect one of these problems, see the corresponding troubleshooting procedure.

Patient-related Causes for Ineffective Stimulation

■ Changes in family circumstances or dynamics

■ Psychological changes

♦ Procedure 5 – Troubleshooting for patient-related causes for ineffective stimulation

1. Review recent changes in patient’s life.

2. Initiate psychotherapy/family counseling, if necessary.

Etiology-related Causes for Ineffective Stimulation

■ Accommodation to stimulation

■ Disease progression resulting in original parameter settings being ineffective.

TroubleshootingIneffective Stimulation




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5Programming at a Glance

Section 5 contains directions for basic programming functions.

Typical Programming Procedures 5-2

Programming at a GlanceTypical Programming Procedures




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Typical Programming Procedures

This chapter is intended as a brief overview of basic device programming using the 8870 Application Card and the Model 8840 N’Vision Clinician Programmer. For in-depth programming instructions, refer to Chapter 3, Programming.

Prior to using the procedures outlined below, ensure that the appropriate application card is inserted in the programmer, that the programmer is turned on, and that the device has been interrogated.

Typically, you should use the stylus to make selections on all programming screens. Thus, when you are directed to “select” a parameter or input box on the screen, use the stylus to touch the parameter or the blank input box associated with that parameter.

Remember that you do not have to program one parameter at a time; the N’Vision Programmer has a batch programming feature. Typically, you may set all target parameters on one screen, and program only once.

Note: When target values have not yet been programmed (when values are pending), many functions are not available. For example:

■ When amplitude is pending, electrode polarity, pulse width, and rate are not accessible.

■ When any target value is pending, navigation between tabs is not possible.

■ When invalid electrode configurations are selected, the program (P) button can not be selected.

■ When special ramp is selected, cycling options are inaccessible.

Inaccessible functions such as those listed above are “greyed out” on the screen.

Note: You cannot navigate from one screen to another if pending target parameters on a screen have not been programmed.





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For a “typical” programming session, follow the instructions below.

Note: Not all of the programming options presented on the following pages are available on all Medtronic neurostimulators.

1. Select the neurostimulator icon from the Application Selection Screen.

2. Place the programming head over the neurostimulator and press the programming (P) button.

3. The programmer will automatically identify the type of neurostimulator implanted. If the application card has been used previously to program the neurostimulator and patient information was entered previously, that information will be automatically available and the programmer will default to the Quick Look Screen.





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4. Check device and patient information provided on the Quick Look Screen (Figure 5-1).

Figure 5-1. Check Device and Patient Information

Note: If you have not previously interrogated your patient’s device with the application card in the programmer, the Patient Profile Screen will appear, and you should enter all patient and device data. Refer to “Enter Patient Information on the Profile Screen” on page 3-12 for specific instructions.





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5. Navigate to the Programming Screen.

Figure 5-2. Programming Screen

6. Select electrode polarities (Figure 5-3).

Figure 5-3. Select Electrode Polarities.





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7. Program pulse width value (Figure 5-4).

Figure 5-4. Change Pulse Width Value

8. Program rate value (Figure 5-5).

Figure 5-5. Change Rate Value

9. Position the programming head over the neurostimulator and press the program ( P ) button.





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10. Program amplitude value and associated parameters (Figure 5-6).

Figure 5-6. Select Amplitude

11. Position the programming head over the neurostimulator and press the program (P) button.





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12. Navigate to the Special Screen (Figure 5-7).

Figure 5-7. Access the Special Screen

13. Select the desired parameter for programming from the drop-down menu (Figure 5-8).

Figure 5-8. Select the Desired Parameter for Programming





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14. For Cycling (if available):

a. Choose a mode (continuous or cycling) (Figure 5-9):

Figure 5-9. Choose a Mode

b. Choose Cycling On and Off times (Figure 5-10):

Figure 5-10. Set Cycling On and Cycling Off times





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c. Set Day Cycling start and stop times, if desired (Figure 5-11):

Figure 5-11. Set Day Cycling Start and Stop Times

d. Set SoftStart/Stop times, if desired (Figure 5-12).

Figure 5-12. Set SoftStart/Stop Times

Movement Disorder Programming Guide, Version A–12/03 A-1


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AGlossary

Amplitude – A measure of the electrical intensity delivered in a stimulating pulse, measured in volts.

Application Card – A small memory card on which Medtronic Neurological therapy applications are housed.

Batch Programming – The action of changing all target (pending) values to actual values during a single communication between the programming head and the implanted device.

Custom Limit – Programmable lower and upper limits that are independent of programmed values.

Cycling Mode – A mode in which the output is alternately cycled on and off automatically.

Cycling Off Time – In a cycling mode, the length of time between stimulation periods; the time of the “resting” period.

Cycling On Time – In a cycling mode, the length of time that stimulation is delivered.

Day Cycling – A method of synchronizing a patient therapy schedule to the 24-hour clock.

Input Box – An area on the programmer touchscreen that, when activated, initiates the appearance of another screen or an action by the programmer.

Lead Impedance – A measure of the resistance of the lead(s), extension(s), and body tissue to device stimulation.

Glossary

A-2 Movement Disorder Programming Guide, Version A–12/03


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Localization Parameters – Options for selecting country-specific formats for date, time, and numbering schemes.

Mode – A type of stimulation delivery.

Program – A combination of electrode, pulse width, rate, and amplitude settings. Programs are also referred to as channels in some literature.

Pulse Width – A measure, in microseconds, of the duration of each stimulating pulse.

Rate – The frequency or speed of stimulation pulses.

Session Data Manager – A feature housed on the Model 8840 N’Vision Clinician Programmer that allows collection and storage of patient data information gathered during patient sessions.

SoftStart/Stop – A feature that gradually increases amplitude from 0V to the target value when the neurostimulator is turned on and gradually decreases the amplitude to 0V when the neurostimulator is turned off.

Stylus – A blunt pen- or pencil-shaped device used to make contact with a touchscreen on a device such as a computer or programmer.

Target Value – Before programming, the intended value of a parameter.

Telemetry – Radio-frequency transmissions between the programmer and the implanted device.

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© Medtronic, Inc. 2005All Rights Reserved

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