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KINETRA ® Dual Program Neurostimulator for Deep Brain Stimulation Rx only Technical Manual 7428

Neurostimulator Kinetra pt. DBS in boala Parkinson

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Page 1: Neurostimulator Kinetra pt. DBS in boala Parkinson

M220822A003 Rev X

7428_FCV.FM 3/15/06 4:14 pmUC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm)

Medtronic Confidentialpackage_R00a

KINETRA®

Dual Program Neurostimulator for Deep Brain Stimulation

Rx only

Technical Manual

7428

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M220822A003 Rev X

7428_ENtpg.fm 3/15/06 4:14 pmUC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm)

Medtronic Confidentialpackage_R00a

KINETRA®

Technical Manual

Model 7428

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Medtronic®, Access®, Activa®, Itrel®, Kinetra®, MemoryMod®, N’Vision®, and Soletra® are registered trademarks of Medtronic, Inc.

DBS™ and SoftStart/Stop™ are trademarks of Medtronic, Inc.

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Table of Contents

Overview of Manual 5System Description 6Indications 6Contraindications 7Warnings 8Precautions 10

Physician Training 10Storage and Sterilization 10System and Therapy 10Implantation/Explantation 12Electromagnetic Interference (EMI) 14Medical Environment 15Home or Occupational Environment 16

Clinical Studies and Adverse Events 18Individualization of Treatment 18Resterilization 18Directions for Use 20

Neurostimulator Implantation or Replacement 20Tunneling to the Neurostimulator Site 21Making the Lead-Extension Connection 21Making the Extension-Neurostimulator Connection 21Explant Disposition 31Environmental Problems 31Handling and Storage 34Patient Registration 34

Physician Training Information 35Patient Counseling Information 36

Theft Detectors and Screening Devices 36

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Component Manipulation by Patient 37Kinetra Patient Eligibility 38

Rate Control 38Screening for Patient Eligibility 38

Detailed Device Description 40General Description 40Postoperative Patient Management 45Programming Stimulation Parameters 49Electrode Programming Configurations 53Test Stimulation 56Specifications and Features 56

How Supplied 63Appendix: Battery Longevity Reference Information 64

Tips for Maximizing Battery Life 64Estimating Battery Life Prior to Neurostimulator Internalization 64Battery Longevity Worksheet 68

Glossary 74

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Overview of Manual

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Overview of Manual

This manual provides information on the Kinetra neurostimulator, a component of the Activa System for deep brain stimulation. The manual describes some items to discuss with your patient, and explains how to register the patient’s device. You will also find instructions for handling, storing, implanting, replacing, and explanting the neurostimulator. General resterilization guidelines are also provided for the new neurostimulator.

The manual is divided into the following sections:■ System Description■ Indications■ Contraindications■ Warnings■ Precautions■ Clinical Studies and Adverse Events■ Individualization of Treatment■ Resterilization■ Directions for Use■ Physician Training Information■ Patient Counseling Information■ Kinetra Patient Eligibility■ Detailed Device Description■ How Supplied■ Appendix: Battery Longevity Reference Information■ Glossary

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System Description

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System Description

The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain.

The dual program Model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via the Model 7482 DBS Extension and either the Model 3387 DBS Lead or the Model 3389 DBS Lead. These components comprise the implantable portion of the Activa System.

The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet.

For a complete list of model numbers and components compatible with the Kinetra Neurostimulator, see the Activa System Components Sheet packaged with this manual in the neurostimulator shelf box.

Indications1

Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson’s Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson’s disease that are not adequately controlled with medication.

1 The dual program Kinetra Model 7428 neurostimulator is not approved for Tremor Control Therapy since only unilateral stimulation is approved for Tremor Control Therapy.

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Contraindications

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Contraindications

Implantation of an Activa Brain Stimulation System is contraindicated for:

■ Patients exposed to diathermy. Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.Diathermy is further prohibited because it can also damage the neurostimulation system components resulting in loss of therapy, requiring additional surgery for system explantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned “on” or “off.” Advise your patients to inform all their health care professionals that they should not be exposed to diathermy treatment.

■ Patients who will be exposed to Magnetic Resonance Imaging (MRI) using a full body transmit radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends over the chest area. Performing MRI with this equipment can cause tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis or death. Refer to the MRI guidelines manual packaged with this product for comprehensive safety information and instructions.

■ Patients for whom test stimulation is unsuccessful.■ Patients who are unable to properly operate the brain

stimulator.

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Warnings

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Warnings

Coagulopathies – Use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should consider underlying factors, such as previous neurological injury, or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.

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 described in “Programming Stimulation Parameters” on page 49.

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.

Case Damage – If the neurostimulator case is ruptured or pierced after implant due to outside forces, severe burns could result from exposure to battery chemicals.

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Warnings

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Placement of Lead-Extension Connector in Neck – Do not place the lead-extension connector in the soft tissues of the neck. Placement in this location has been associated with an increased incidence of lead fracture.

Theft Detectors and Screening Devices – Theft detectors found in retail stores, public libraries, etc., and airport/security screening devices may cause the stimulation power source of an implantable neurostimulation system to switch On or Off1. It is also possible that sensitive patients, or those with low stimulation thresholds, may experience a momentary increase in their perceived stimulation. For other indications, higher levels of stimulation have been described as uncomfortable (“jolting” or “shocking”) by some patients as they pass through these devices. Refer to “Patient Counseling Information” on page 36 for more information.

Replacement Procedure – Do not replace two Soletra Model 7426 Neurostimulators with one Kinetra Model 7428 Neurostimulator unless retunneling is performed so both lead-extensions are on the same side of the body. Otherwise, the “looped” configuration formed by the lead-extensions increases the potential for electromagnetic interference (EMI) effects.

Magnetic Resonance Imaging – Do not conduct an MRI examination on a patient with any implanted Activa System component until you read and fully understand all MRI information in this manual. Do not conduct an MRI examination at parameters other than those described in this guideline. Failure to follow all warnings and guidelines related to MRI can result in serious and permanent injury including coma, paralysis, or death. Refer to the MRI guidelines manual packaged with this product for comprehensive safety information and instructions.

1 Unexpected On/Off switching of the Kinetra Model 7428 Neurostimulator, as described throughout the Warnings and Precautions sections of this manual, may be avoided by disabling the magnet control circuit with the clinician programmer software. If the magnet control circuit is disabled, patients will require a Model 7436 Therapy Controller to turn their therapy On or Off. Refer to “Control Magnet” on page 44.

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Precautions

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Precautions

Physician Training

Implanting Physicians – Implanting physicians should be experienced in stereotactic and functional neurosurgery. Refer to “Physician Training Information” on page 35 in this manual for further information.

Prescribing Physicians – Prescribing physicians should be experienced in the diagnosis and treatment of movement disorders and should be familiar with the use of the Activa System.

Storage and Sterilization

Resterilization Considerations – Refer to “Resterilization” on page 18 for further information.

Storage Temperature – Store the Model 7428 Neurostimulator between 0° F (-18° C) and 131° F (55° C). Temperatures outside this range can damage components.

System and Therapy

Battery Longevity and Brain Target Selection – Stimulation settings for systems implanted in the internal Globus Pallidus (GPi) may be higher than stimulation settings for systems implanted in the Subthalmic Nucleus (STN). Consequently, systems implanted in the GPi may have shorter battery life than systems implanted in the STN.

Component Failures – The Activa System may unexpectedly cease to function due to battery depletion or other causes. These events, which can include electrical short or open circuits, conductor (wire) fracture, and insulation breaches, cannot be predicted. The patient’s disease symptoms will return if the device ceases to function.

Components – The use of non-Medtronic components with this system may result in damage to Medtronic components, loss of stimulation, or patient injury.

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Precautions

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Inadvertent Programming – If more than one neurostimulator is implanted, then the potential for unintentional programming changes to the other neurostimulator exists. If two neurostimulators are implanted, they must be implanted at least 8 inches apart to minimize interference. Verify final programmed parameters by reviewing both devices at the conclusion of any programming session.

Lead Materials – The polyurethane tubing of the lead may release neurotoxic or carcinogenic compounds. Data are insufficient to assess the likelihood of these effects occurring in patients who receive the device.

Long-Term Safety and Effectiveness of Activa Therapy – The long-term safety and effectiveness of Activa Therapy has not been established.

Use in Specific Populations – The safety and effectiveness of this therapy has not been established for the following:

■ Patients with neurological disease origins other than idiopathic Parkinson’s disease

■ Patients with a previous surgical ablation procedure■ Patients who are pregnant■ Patients under the age of 18 years■ Patients over the age of 75 years■ Patients with dementia■ Patients with coagulopathies■ Patients with moderate to severe depression

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Precautions

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Implantation/Explantation

Body Fluids – Do not resterilize any system component after exposure to body fluids.

Component Disposal – If explanting an Activa System component, please remember the following guidelines:

■ Do not incinerate or cremate the neurostimulator; explosion can result if a neurostimulator is subjected to incineration or cremation temperatures.

■ Return all explanted components to Medtronic for analysis and safe disposal.

Connections – Wipe off any body fluids on the extension or lead contacts or connector before connecting. Contamination of connections can cause intermittent stimulation or shorts in the neurostimulation circuit.

Connector Block Setscrews – Limit counter-clockwise rotations of neurostimulator setscrews. Rotate enough to provide an unobstructed pathway for the extension connector pins. Too many counter-clockwise rotations may disengage the setscrew from the connector block.

Etched Identification – Place the neurostimulator away from bony structures and with the etched identification side facing outward, away from muscle tissue to minimize pain at the neurostimulator site. This also helps to minimize the possibility of skeletal muscle stimulation, which may be perceived by the patient as twitching or burning.

Excess Extension Wire – Do not place any excess extension wire on top of the neurostimulator’s front side (printed side). Wrap any excess extension wire around the perimeter (Figure 1). This avoids any increase in subcutaneous pocket depth, helps minimize potential damage during neurostimulator replacement surgery, and helps minimize potential kinking of the extension wire.

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Precautions

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Figure 1. Wrap excess wire around the perimeter of the neurostimulator.

Handling Components – Handle the implanted components of this system with extreme care. These components may be nicked, cut, or damaged by excessive traction or sharp instruments and may require surgical replacement.

■ Do not bend, kink, or stretch the lead body whether or not the stylet is in place. Do not bend or kink the tungsten stylet.

■ Do not tie a suture directly to the extension or lead body. Use the burr hole cap and ring provided by Medtronic to secure the lead in place.

■ When handling the lead with forceps, use only a rubber-tipped bayonet forceps.

Hex Wrench – Do not overtighten setscrews when using the hex wrench. Excessive torque on setscrews may damage lead contacts. Verify that the sealing grommet has closed on the neurostimulator.

Implant Considerations – Do not implant a component of the system when:

■ The storage package has been pierced or altered; or if the component shows signs of damage; or

■ The “Use By” date has expired, because this can adversely affect storage package sterility.

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Precautions

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Multiple Implants – The long-term safety associated with leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown.

Percutaneous Extension Setscrew Connector – If resistance is still felt when removing lead from the percutaneous extension setscrew connector, loosen the setscrews slightly to ensure that they clear the lead contacts. Avoid disengaging the setscrews. Inspect the lead contacts for damage (flattening or stretching of the lead) if resistance was felt prior to removal.

Percutaneous Extension Severing – When severing the percutaneous extension, use gentle traction on the extension to avoid dislodging the lead.

Percutaneous Extension Suture Removal – Do not cut near the lead when removing sutures from the percutaneous extension. Cutting the lead’s insulation can result in loss of stimulation and the lead’s failure.

Sutures – Do not draw the suture too tightly because damage may occur to the connector boot or to the extension or lead.

Torque Wrench – To prevent undertightening the neurostimulator setscrews, do not use the torque wrench from the extension kit. Undertightening may result in insufficient electrical contact within the connector block, which may cause intermittent stimulation.

Electromagnetic Interference (EMI)

Electromagnetic interference is a field (electrical, magnetic or a combination of both) that is generated by various medical or environmental devices. These medical and environmental (home, occupational, and other) devices may generate enough interference to change the parameters of a neurostimulator; turn a neurostimulator off and on, or cause a neurostimulator to surge, shock, or jolt the patient.

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Precautions

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In addition, it is possible for the extension, lead, or both to “pick up” electromagnetic interference and deliver an excess voltage, which can in turn deliver an excessive amount of heat to the brain. Refer to the sections that follow for guidelines on the interaction of electromagnetic interference and an implanted Activa System.

Medical Environment

Most routine diagnostic procedures, such as fluoroscopy and x-rays, are not expected to affect system operation. However, because of higher energy levels, sources such as transmitting antennas found on various diagnostic and therapeutic equipment may interfere with the Activa System.

Effects on Other Medical Devices – The Activa System may affect the operation of other implanted devices, such as cardiac pacemakers and implantable defibrillators. Possible effects include sensing problems and inappropriate device responses. If the patient requires concurrent implantable pacemaker and/or defibrillator therapy, careful programming of each system may be necessary to optimize the patient’s benefit from each device.

Electrocautery – Electrocautery can damage the lead, the extension, or both. It can also cause temporary suppression of neurostimulator output and/or reprogramming of the neurostimulator. If use of electrocautery is necessary, the current path (ground plate) should be kept as far away from the neurostimulator, extension, and lead as possible, and use of bipolar electrocautery is recommended.

External Defibrillators – If a patient requires external defibrillation, the first consideration should be patient survival. Safety for use of external defibrillatory discharges on patients with neurostimulation systems has not been established. External defibrillation may damage a neurostimulator.

If external defibrillation is necessary, follow these precautions to minimize current flowing through the neurostimulator and lead system:

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Precautions

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■ Position defibrillation paddles as far from the neurostimulator as possible.

■ Position defibrillation paddles perpendicular to the implanted neurostimulator-lead system.

■ Use the lowest clinically appropriate energy output (watt seconds).

■ Confirm neurostimulation system function following any external defibrillation.

High Radiation Sources – High radiation sources, such as cobalt 60 or gamma radiation, should not be directed at the neurostimulator. If a patient requires radiation therapy in the vicinity of the neurostimulator, place lead shielding over the device to prevent radiation damage.

Lithotripsy – Use of high output ultrasonic devices, such as an electrohydraulic lithotriptor, is not recommended for patients with an implanted neurostimulation system. While there is no danger to the patient, exposure to high output ultrasonic frequencies may result in damage to the neurostimulator circuitry. If lithotripsy must be used, do not focus the beam near the neurostimulator.

Psychotherapeutic Procedures – The safety of psychotherapeutic procedures using equipment that generates electromagnetic interference (e.g., electroshock therapy, transcranial magnetic stimulation) has not been established.

Home or Occupational Environment

Home Appliances – Home appliances that are in good working order and properly grounded do not usually produce enough electromagnetic interference (EMI) to interfere with neurostimulator operation. However, items with magnets (e.g., stereo speakers, refrigerators, freezers, power tools) may cause the neurostimulator to switch On or Off.

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Precautions

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Occupational Environments – Commercial electrical equipment (arc welders, induction furnaces, resistance welders), communication equipment (microwave transmitters, linear power amplifiers, high-power amateur transmitters), and high voltage power lines may generate enough electromagnetic interference (EMI) to interfere with neurostimulator operation if approached too closely.

Patient Activities/Environmental Precautions – Patients should exercise reasonable caution in avoidance of devices which generate a strong electric or magnetic field. Close proximity to high levels of electromagnetic interference (EMI) may cause a neurostimulator to switch On or Off. The system also may unexpectedly cease to function due to battery depletion or other causes. For these reasons, the patient should be advised about any activities that would be potentially unsafe if their symptoms unexpectedly return. For additional information about devices which generate electromagnetic interference, call Medtronic at 1-800-707-0933.

Patient Magnet – The magnet provided to the patient for device activation and deactivation may damage televisions, computer disks, computer monitors, credit cards, and other items affected by strong magnetic fields.

Radio Frequency Sources – Analog and digital cellular phones, AM/FM radios, cordless phones, and conventional wired telephones may contain permanent magnets. To prevent undesired turning On or Off of the stimulation, these devices should be kept at least 4 inches away from the implanted neurostimulator.

Therapeutic Magnets – Therapeutic magnets (for example, those found in bracelets, back braces, shoe inserts and mattress pads) can cause inadvertent on or off activations of the neurostimulator. Therefore, patients should be advised not to use them.

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Clinical Studies and Adverse Events

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Clinical Studies and Adverse Events

The clinical use of the Kinetra Model 7428 Neurostimulator is supported by the Medtronic Parkinson’s disease clinical studies using the Itrel II Model 7424 Neurostimulator. For results of the Parkinson’s disease clinical trials and a complete list of adverse events reported during the Parkinson’s disease clinical trials, refer to the Activa Clinical Summary packaged with this product.

Because safety and effectiveness of the Activa Parkinson’s Control therapy was established using bilateral Itrel II neurostimulators, clinical results and adverse event rates associated with a single dual-channel Kinetra neurostimulator may not be identical.

Individualization of Treatment

For information about individualization of treatment, refer to the Activa Clinical Summary packaged with this product.

Resterilization

The implantable components of the Activa System were sterilized with ethylene oxide prior to shipment. The package should be inspected for damage prior to use. If you are unsure of the components’ sterility for any reason, they can be resterilized at the hospital site.

Note: If contamination is suspected because of a defective sterile package seal, the neurostimulator and accessories can be returned to Medtronic for replacement or they can be resterilized at the hospital. Replacements are otherwise subject to the terms of the Medtronic Limited Warranty (US Customers). Medtronic does not accept returned neurostimulators or accessories for resterilization and return them to customers.

Because of variations in hospital sterilizers, precise instructions for sterilization or aeration cannot be given here. If further information is

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Resterilization

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necessary regarding the procedures to be used, contact the manufacturer of the sterilizer unit. Use biological indicators or other acceptable methods to validate the effectiveness of the hospital’s sterilizer unit.

Medtronic cannot accept the responsibility for the hospital’s resterilization of any components. If, however, the hospital decides to resterilize, usual and customary sterilization methods should be used.

Subject to the foregoing, the following may be considered:

Ethylene oxide is an acceptable method for resterilization when the neurostimulator and accessories are repackaged in an ethylene oxide-permeable package. The temperature during the process should not exceed 131° F (55° C). The maximum possible aeration must be allowed before implanting the neurostimulator and using the accessories.

Resterilization of a neurostimulator does not change the Use By date established at the time of manufacture, because the date is based on battery life.

Steam autoclaving may be used for the hex wrenches only.

To autoclave the hex wrenches, a standard cycle of 30 minutes at 250° F (121° C) and 15 psig is recommended. For “flash” autoclave, a standard cycle of 5 minutes at 270° F (132° C) and 27 psig is recommended.

# Cautions:

■ Do not resterilize and use the neurostimulator or accessories after exposure to body tissues or fluids.

■ Do not use radiation to resterilize any component. DO NOT AUTOCLAVE the neurostimulator. DO NOT CLEAN the neurostimulator in ULTRASONIC CLEANERS.

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Directions for Use

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Directions for Use

Neurostimulator Implantation or Replacement

This section outlines the basic steps of the suggested procedure for implanting or replacing the neurostimulator. Refer to the appropriate extension implant manual for specific information related to the extension implant procedure. Once the verification of the efficacy of deep brain stimulation for your patient has been determined during the test stimulation procedure, the extension and neurostimulator may be implanted.

To implant the neurostimulator:

1. Remove the percutaneous extension(s), if used, in accordance with the procedure outlined in the appropriate extension manual.

2. Create a subcutaneous pocket for the neurostimulator using blunt dissection in the subclavicular region.Notes:■ If MRI is planned, avoid, if possible, implanting the

neurostimulator in the abdomen. This requires the use of a longer length lead/extension system that can increase heating from MRI induced RF currents, especially at the lead electrodes. See the MRI guidelines manual packaged with this product for comprehensive safety information and instructions.

■ The neurostimulator should be located no more than 1.5 inches (4.0 cm) beneath the surface of the skin in subcutaneous tissue to allow proper programming. The device must be placed parallel to the skin surface. The etched identification side of the neurostimulator must face outward, away from muscle. When placing two neurostimulators, ensure a minimum of 8 inches (20 cm) separates the two to prevent cross-programming.

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Directions for Use

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■ In placing the neurostimulator, take into account the possibility of future cardiac needs (e.g., pacemakers, defibrillators, etc.). Implanting the neurostimulator on the right side allows for possible future placement of cardiac devices on the left side.

3. Place the neurostimulator in the pocket to assure a proper fit and then remove it.

Tunneling to the Neurostimulator Site

For instructions on tunneling to the neurostimulator site refer to the appropriate extension manual.

Making the Lead-Extension Connection

For instructions on making the lead-extension connection refer to the appropriate extension manual.

Making the Extension-Neurostimulator Connection

To make the connection between the extension and the neurostimulator:

1. Check the neurostimulator connector block and determine if any setscrews obstruct the socket. If necessary, partially back out the setscrews.a. To back out a setscrew, insert the hex wrench through the

pre-pierced hole in the rubber grommet and turn the

# Caution: Place the neurostimulator away from bony structures with the etched identification side facing outward, away from muscle tissue to minimize pain at the neurostimulator site, and to minimize the possibility of skeletal muscle stimulation, which may be perceived by patients as twitching or burning.

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setscrew counterclockwise only until the socket is unobstructed (Figure 2).

Note: With the Kinetra Model 7428 Neurostimulator, four setscrews are located on top of the connector module, two for each extension. Two setscrews are oriented at a 90° angle and two are oriented at a 45° angle.

Figure 2. Insert hex wrench in rubber grommet and turn setscrew counterclockwise to back out setscrew.

b. Wipe off any body fluids from the extension connector pins and connector block.

c. Check that the encapsulated diagram on the extension matches the diagram on the neurostimulator.

d. Insert the Extension 1 connector pins fully into Socket I. Socket I corresponds to electrodes 0-3 on Lead 1.

# Caution: Limit counterclockwise rotations of the setscrews. Rotate enough to provide an unobstructed pathway for extension connector pins. Too many rotations may disengage the setscrew from the neurostimulator connector block.

45° Angle 90° Angle

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e. Insert the Extension 2 connector pins fully into Socket II (Figure 3). Socket II corresponds to electrodes 4-7 on Lead 2.

Note: If inserting the extension pins is still difficult, use sterile water as a lubricant.

Figure 3. Insert extension connector pins into neurostimulator sockets.

2. Once the extension connector pins are fully inserted in the neurostimulator sockets, do the following for each of the four setscrews:a. Insert the hex wrench through the rubber grommet to

engage the setscrew.b. Tighten the setscrew by turning the hex wrench clockwise

until resistance is felt (Figure 4).c. Continue tightening for a maximum of 1/4 turn. The

setscrews must touch the extension connector pins for proper electrical connection.

Note: When tightening the setscrews, the hex wrench must be oriented at the same angle as the setscrews (Figure 4).

Socket I(Electrodes 0-3)

Socket II(Electrodes 4-7)

Extension 1 Extension 2

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Figure 4. Insert hex wrench and tighten all four setscrews.

Note: The sealing rings within the neurostimulator connector block are designed to form a seal with the extension connector pins. No sealant or sutures are required.

# Cautions:■ To prevent undertightening the neurostimulator

setscrews, do not use the torque wrench from the extension kit. Undertightening may result in insufficient electrical contact within the connector block, which may cause intermittent stimulation.

■ Do not overtighten the setscrews or permanent damage to the setscrews and/or sockets could result.

■ Be sure the hex wrench is fully inserted to prevent damage to the setscrew.

■ Verify that each leaf of the sealing rubber grommet has closed after the wrench is withdrawn. If the grommet seal is not fully closed, the patient may experience shocking, burning, or irritation at the neurostimulator implant site. In addition, fluid leakage into the setscrew connector block may result in changes to stimulation.

45° Angle 90° Angle

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3. Place the neurostimulator into the subcutaneous pocket (Figure 5). Position the neurostimulator so that no sharp bends occur along the extension or lead (Figure 6).

Figure 5. Place neurostimulator into subcutaneous pocket.

# Caution: Place the neurostimulator away from bony structures and with the etched identification side facing outward, away from muscle tissue to minimize pain at the neurostimulator site, and to minimize possibility of skeletal muscle stimulation, which may be perceived by the patient as twitching or burning.

# Caution: Do not loop or coil the extension on top of the neurostimulator’s etched identification side. Wrap any excess extension wire around the perimeter of the neurostimulator (Figure 6). This avoids any increase in subcutaneous pocket depth, minimizes potential damage during replacement surgery, and minimizes potential kinking of the extension wire.

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Figure 6. Wrap excess wire around the perimeter of the neurostimulator.

4. Secure the neurostimulator in the subcutaneous pocket, using the suture holes in the connector block to secure it to the muscle fascia. (Figure 7).

Figure 7. Suture hole locations on neurostimulator connector block.

5. Check the stimulation parameters.

6. Confirm that the desired program is stimulating the desired area (e.g., that Program 1 [Lead 1] stimulates the left side and Program 2 [Lead 2] stimulates the right side).

7. Close and dress the incision.

Suture Holes

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8. Complete the patient registration form and mail it to Medtronic.

Note: If only one lead is implanted at this time, perform the following steps using the accessories from the Model 3550-09 Accessory Kit:■ 1 Lead, 1 Extension—Insert the neurostimulator

connector plug into the unused socket of the neurostimulator connector block and tighten the setscrews (Figure 8).

Figure 8. Insert connector plug into unused neurostimulator socket.■ 1 Lead, 2 Extensions—Slide the closed boot over the

extension’s setscrew connector and secure with sutures (Figure 9).

w Warning: If the neurostimulator case is ruptured or pierced after implant due to outside forces, severe burns could result from exposure to battery chemicals.

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Figure 9. Slide closed boot over extension setscrew connector and suture.

To replace the Kinetra Neurostimulator:

1. Open the neurostimulator implant site per normal surgical procedure, and carefully remove the neurostimulator from the subcutaneous pocket.

2. Clean the neurostimulator and extension connector with sterile water; wipe both dry with surgical sponges.

3. Insert the hex wrench included in the package through the pre-pierced hole in the rubber sealing grommet, and loosen the setscrews by turning counterclockwise (Figure 2).

4. Gently retract the extension pins from the neurostimulator connector. If the extension pins show any signs of pitting corrosion, the extension should be replaced. Clean and dry both the pins and extension connector body—they must be free of fluids or tissue.

5. Check the neurostimulator connector and determine if any setscrews obstruct the socket space. If necessary, back out the setscrews.

6. Insert the Extension 1 connector pins fully into Socket I. Socket I corresponds to electrodes 0-3 on Lead 1.

7. Insert the Extension 2 connector pins fully into Socket II (refer to Figure 3). Socket II corresponds to electrodes 4-7 on Lead 2.

# Caution: Use care to avoid damaging the extension wire which may be wrapped around the perimeter of the neurostimulator.

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8. Tighten each setscrew clockwise until it touches the connector pin—continue tightening for a maximum of 1/4 turn only (Figure 4). When tightening the setscrews, the hex wrench must be oriented at the same angle as the setscrews (refer to Figure 4). After you remove the wrench, check that the sealing rubber grommet has closed.

9. Place the new neurostimulator into the subcutaneous pocket, with the etched identification side facing outward, and secure.Note: The neurostimulator should be located no more than 1.5 inches (4.0 cm) beneath the surface of the skin in subcutaneous tissue to allow proper programming. The device must be placed parallel to the skin surface. The etched identification side of the neurostimulator must face outward, away from muscle. If another neurostimulator is already implanted or planned for the future, ensure at least 8 inches (20 cm) between the two.

# Cautions:■ To prevent undertightening the neurostimulator

setscrews, do not use the torque wrench from the extension kit. Undertightening may result in insufficient electrical contact within the connector block, which may cause intermittent stimulation.

■ Do not overtighten the setscrews or permanent damage to the setscrews and/or sockets could result.

■ Be sure the hex wrench is fully inserted to prevent damage to the setscrew.

■ Verify that each leaf of the sealing rubber grommet has closed after the wrench is withdrawn. If the grommet seal is not fully closed, the patient may experience shocking, burning, or irritation at the neurostimulator implant site. In addition, fluid leakage into the setscrew connector block may result in changes to stimulation.

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10. Use the suture holes in the connector block to secure the neurostimulator in the subcutaneous pocket. Use normally available surgical needles and sutures.

11. Check the stimulation parameters.

12. Confirm that the desired program is stimulating the desired area (e.g., that Program 1 (Lead 1) stimulates the left side and Program 2 (Lead 2) stimulates the right side).

13. Close the neurostimulator pocket incision.

14. Fill out and mail the implant registration form to Medtronic.

# Cautions:

■ Place the neurostimulator away from bony structures and with the etched identification side facing outward, away from muscle tissue to minimize pain at the neurostimulator site, and to minimize possibility of skeletal muscle stimulation, which may be perceived by the patient as twitching or burning.

■ Do not loop or coil the extension on top of the neurostimulator’s etched identification side. Wrap any excess extension wire around the perimeter of the neurostimulator (Figure 6). This avoids any increase in subcutaneous pocket depth, minimizes potential damage during replacement surgery, and minimizes potential kinking of the extension wire.

w Warning: If the neurostimulator case is ruptured or pierced after implant due to outside forces, severe burns could result from exposure to battery chemicals.

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Explant Disposition

Explanted products must be returned to Medtronic for proper disposal. Please include an explanation of explant on the Returned Product Information Report that is packaged with the Self-addressed Mailer Kits provided by Medtronic.

Return explanted products to:

Medtronic Inc.Neurological DivisionReturned Product AnalysisMS N600P.O. Box 1250Minneapolis, MN 55440-9087

The self-addressed mailer kits are available from your Medtronic Sales Representative.

Environmental Problems

Kinetra neurostimulators are designed to assure immunity from most common sources of electromagnetic interference (EMI). Because many different types of EMI sources exist, it is impossible to specify all interference sources here. However, the most common sources of EMI are discussed below.

Hospital or Medical Environment

Kinetra neurostimulators have been tested for electromagnetic compatibility (EMC) in electrical and magnetic fields that simulate common sources of EMI found in a hospital environment. Severe electromagnetic fields, such as those that exist near electrocautery equipment, can reprogram a neurostimulator, temporarily suppress the output of a neurostimulator, and cause damage to the implanted system components.

Telemetry usually continues to function but may indicate that the neurostimulator output is On when, in fact, no stimulation is being delivered because the amplitude is set to 0.0 V. Kinetra

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neurostimulators have a protective circuit to prevent damage to the circuitry, but a large burst of electromagnetic energy may temporarily affect the output and/or the ability to reprogram the device. Severe EMI (e.g., electrocautery, defibrillatory discharge, MRI) can also erase the neurostimulator serial number.

Refer to the section Precautions: Medical Environment for information on the interaction between specific medical equipment and the Activa System.

Home or Job Environment

Kinetra neurostimulators should not be affected by normal operation of electrical equipment such as household appliances, electric machine shop tools, microwave ovens, RF transmitting systems, or microwave frequency transmitting systems. A strong magnetic field (electromagnet or permanent magnet) can switch the neurostimulator output from On to Off or Off to On1, but does not change the programmed parameters.

In addition, theft detectors and airport/security screening devices can affect the neurostimulator output and patient stimulation.

Advise your patients to use care when approaching theft detectors or airport/security screening devices. If they feel unwanted stimulation as they approach the device, suggest that they request assistance to bypass the device.

1 Unexpected On/Off switching of the Kinetra Model 7428 Neurostimulator may be avoided by disabling the magnet control circuit with the clinician programmer software. If the magnet control circuit is disabled, patients will require a Model 7436 Therapy Controller to turn their therapy On or Off. Refer to “Control Magnet” on page 44.

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Advise your patients to avoid or to exercise care when approaching the following:

■ Theft detectors■ Airport/security screening devices■ Large stereo speakers with magnets■ Electric arc welding equipment■ Electric steel furnaces■ Electric induction heaters (used in industry to bend plastic)■ Power lines■ Electric substations and power generators

If your patient suspects an electrical device or magnet is interfering with the neurostimulator, advise him/her to move away from it, or turn the device off. Then, the patient can use the control magnet or therapy controller to set the neurostimulator back to the desired On or Off state. When switched On, the neurostimulator will resume stimulation at the previously programmed level.

w Warning: Theft detectors found in retail stores, public libraries, etc., and airport/security screening devices may cause the stimulation power source of an implantable neurostimulation system to switch On or Off. It is also possible that sensitive patients, or those with low stimulation thresholds, may experience a momentary increase in their perceived stimulation. For other indications, higher levels of stimulation have been described as uncomfortable (“jolting” or “shocking”) by some patients as they pass through these devices. Refer to “Patient Counseling Information” on page 36 for more information.

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Handling and Storage

The neurostimulator can be damaged if dropped on a hard surface, that is, dropped from a height of 30 cm (12 in.) or more onto a surface like a concrete floor. If this happens, the unit should not be implanted. The neurostimulator should not be stored at temperatures above 131° F (55° C) or below 0° F (-18° C).

Patient Registration

Inside the shipping container for each Kinetra Neurostimulator is an implant registration form that creates a permanent record of your patient’s implant. It is important that you complete the form and promptly return the original to Medtronic, Inc. Three copies are provided for the patient’s medical records.

Medtronic will transfer vital information to a wallet-sized, plastic-coated identification card and will mail it directly to the patient. A temporary identification card is packaged with the neurostimulator for the patient’s use until the permanent card arrives.

In addition to the patient identification card, the information on the form registers the device warranties and creates a record of the implant in Medtronic’s implant data system. The information in this system ensures compliance with the Safe Medical Devices Act (USA).

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Physician Training Information

Prescribing physicians should have expertise in the medical treatment of patients with movement disorders. Implanting physicians should have expertise with functional stereotactic neurosurgical treatment of movement disorders. Such expertise should include knowledge of the anatomical and neurophysiological characteristics of the targeted nucleus, surgical and /or implantation techniques for the Activa System, operational and functional characteristics of the Activa System, and experience in the continued management of patients by stimulation parameter adjustment. Physicians may contact Medtronic before prescribing or implanting an Activa System for the first time and request a referral to a physician experienced in the use of Activa Therapy.

All Activa System programming should be by or under the supervision of a physician or other experienced medical personnel familiar with the use of the programming software and equipment. Physicians should be thoroughly familiar with Activa System supporting material, including:

■ All product labeling, and■ Education and training materials.

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Patient Counseling Information

Before surgery, the patient and family should be advised of the known risks of the surgical procedure and the therapy, as discussed in other sections of this manual, as well as the potential benefits. After the Activa System is implanted, the patient should also be advised to read the patient manual included in the neurostimulator package.

Theft Detectors and Screening Devices

Patients should be advised to use care when approaching security arches or gates (such as those found in airports, libraries, and some department stores) because these devices can turn on or turn off their neurostimulator. If an airport security wand is used, they should ask the security personnel to avoid placing the wand over the neurostimulator.

When approaching these devices, patients should do the following:

1. If security personnel are present, show them the neurostimulator identification card and request a hand search.

2. If patients must pass through the security device, they should approach the center of the device and walk normally (Figure 10).a. If two security gates are present, they should walk through

the middle, keeping as far away as possible from each gate.

b. If one gate is present, they should walk as far away as possible from it.

Note: Some theft detectors may not be visible.

3. Proceed through the security arch or gate. Do not touch, lean on or linger near the security arch or gate.

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Figure 10. Approaching security gates.

4. If patients suspect that their neurostimulator was turned off, they should make sure someone is able to turn on the system again. (This person could be the patient, if his or her medical condition allows it. It could also be a family member or clinician who has been taught how to use the system.)

Component Manipulation by Patient

Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). This can result in component damage.

Double Security

Gate

Single Security Gate (Stay as far away as possible

from gate)

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Kinetra Patient Eligibility

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Kinetra Patient Eligibility

Prior to neurostimulator implant, ensure that the Kinetra Neurostimulation System is appropriate for your patient.

Rate Control

If independent rate control is desired to provide adequate symptom control for your patient, be aware that rate parameter values are not independently programmable with the Kinetra Model 7428 neurostimulator. Consider implanting two Soletra Model 7426 neurostimulators if independent rate values are desired.

Note: In Medtronic’s clinical studies of the Itrel II Model 7424 neurostimulator for advanced Parkinson’s disease, at least 58% of all subjects had identical rates bilaterally at all follow-up visits.

Screening for Patient Eligibility

Verify that the screening parameters do not exceed the maximum amplitude shown in Table 1 on page 39. If test stimulation is unsuccessful or if parameter settings to achieve therapeutic benefit are within the charge density warning area (refer to Figure 13 on page 52), the system should not be implanted.

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Table 1. Maximum Amplitude (Volts) Available for Specific Rate/Pulse Width Combinations.a,b

a This table is based on data collected with a 1000 ohm resistive load. If the screening rate is between table settings, use the next higher rate.

b The shaded area has upper limits that exceed the charge density warning threshold. See Figure 13 on page 52.

Pulse Width (Microseconds)

60 90 120 150 180 210

Rate (Hz) 130 9.5 V 9.5 V 9.5 V 9.0 V 8.0 V 7.5 V

140 9.5 V 9.5 V 9.0 V 8.5 V 8.0 V 7.5 V

150 9.5 V 9.5 V 9.0 V 8.0 V 7.5 V 7.0 V

160 9.5 V 9.5 V 8.5 V 8.0 V 7.0 V 6.5 V

170 9.5 V 9.5 V 8.5 V 7.5 V 6.5 V 6.5 V

185 9.5 V 9.0 V 8.0 V 7.0 V 6.5 V 6.0 V

200 9.5 V 8.5 V 7.5 V 7.0 V 6.0 V 5.5 V

220 9.0 V 8.0 V 7.5 V 6.5 V 5.5 V 5.0 V

250 9.0 V 7.5 V 7.5 V 5.5 V 5.0 V 4.5 V

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Detailed Device Description

General Description

The Kinetra Neurostimulator has a wide range of noninvasively programmable parameters and stimulation modes. The neurostimulator provides current parameter information, via telemetry, when used with the clinician programmer. The following sections outline the major neurostimulator features.

Programs

The stimulation pulses delivered to each lead are determined by a parameter called a program. A program is a specific combination of amplitude, rate, and pulse width parameters acting on a specific electrode set. The Kinetra Model 7428 Neurostimulator has two available programs (P1 and P2). Program 1 corresponds to Lead 1 (electrodes 0-3 and the case) and Program 2 corresponds to Lead 2 (electrodes 4-7 and the case). Rate is not independently programmable; one programmed setting determines the rate for both programs.

Dual-Program Stimulation

Dual-program pulses are delivered alternately rather than simultaneously. Program 1 delivers an output pulse at its programmed amplitude and pulse width parameters, followed by the Program 2 output pulse at its programmed amplitude and pulse width parameters. This sequence is repeated, with single output pulses alternately delivered. Figure 11 illustrates dual-program operation.

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Figure 11. Examples of dual-program stimulation.

Programmable Functions

The Kinetra Neurostimulator is programmed with either the Model 7432 Clinician Programmer and the MemoryMod Model 7459 Software Cartridge or the Model 8840 Clinician Programmer and the Model 8870 Application Card.

The clinician programmer is used to program the stimulation parameters for both programs by telemetry. It controls various parameters and stimulation modes (Table 2). The clinician programmer displays instruction “prompts” and shows parameter data. A “hard-copy” printout can also be produced during a programming sequence. Some features include Day Cycling, SoftStart/Stop, and Control Magnet Enable/Disable. Patient use information is also available. Neurostimulator internal counters automatically monitor items such as total stimulation time and total number of activations.

The Access Model 7436 Therapy Controller allows the patient to turn the neurostimulator on and off and check the neurostimulator battery status (device shipped with these features active). In addition, the Kinetra Neurostimulator can be programmed with upper and lower limits for amplitude, pulse width, and rate. The Kinetra

Lead 1 (P1)Lead 2 (P2)

Lead 1 (P1)Lead 2 (P2)

1 Rate is always the same for both programs

Different amplitude and pulse width on both programs1

Same amplitude and pulse width on both programs1

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Neurostimulator is shipped with these optional limits set to ±0. When these optional limits are enabled by the physician, patients can adjust their stimulation within the prescribed limits using the therapy controller. These optional limits may not be appropriate for all patients. Physician discretion will need to be exercised to determine whether an individual patient or caregiver is capable of managing parameter control.

For a complete description of programmable functions, refer to the manuals supplied with the software and therapy controller. Programmers made by other manufacturers are not compatible with the Kinetra Model 7428 Neurostimulator.

Table 2. Kinetra Model 7428 Controlling Devices and Functions.

Controlling Device Function

7432 Programmer with 7459 Software8840 Programmer with 8870 Software

• Switches Neurostimulator Output On/Off and provides neurostimulator battery status

• Programs Stimulation Parameters and limits for Programs 1 and 2

• Programs Stimulation Modes• Collects Measurements and Diagnostic Data• Programs Special Features

7436 Therapy Controller

• Switches Neurostimulator Output On/Off• Gives Neurostimulator On/Off Status• Adjusts Stimulation Parameters within

Physician Prescribed Limits for both Programs• Provides Neurostimulator Battery Status

7452 Control Magnet

• Switches Output On/Off if the magnet function has been enabled with the clinician programmer

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For a description of programmer operations and programming functions, refer to the appropriate hardware technical manual or software programming guide.

Telemetry Data

The Kinetra neurostimulator is capable of providing telemetry data transmissions when properly reviewed by the clinician programmer. Upon interrogation, Kinetra neurostimulators will transmit the following via a radiofrequency (RF) link to the clinician programmer for display or printing:

■ Model and serial number identification ■ Programmed parameters and values ■ Neurostimulator battery status ■ Number of patient activations (since last reset)■ Total stimulation time (since last reset) ■ Elapsed time (since last reset)■ Verification of program changes

After a program entry, the programmer compares neurostimulator parameters, via telemetry, with the entries made during programming. The neurostimulator parameter or mode is changed to match the entry and the new value or mode is registered on the display.

Only the clinician programmer can receive and display telemetry data from the neurostimulator.

# Caution: Do not send a patient home with any invalid values for programmable parameters displayed on the programmer screen. They must be reprogrammed to valid parameter values. Note that severe EMI (e.g., electrocautery, defibrillatory discharges, MRI) can erase the neurostimulator serial number.

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Control Magnet

The control magnet enables your patient to switch the neurostimulator output On or Off. The patient briefly applies the Medtronic Model 7452 Control Magnet over the implanted neurostimulator and then removes it to turn the neurostimulator On or Off. Application of the magnet for 2 seconds followed by removal causes the output circuit to turn On or Off.

The magnet On/Off control circuit is enabled when the flat edge of the magnet is applied over the neurostimulator implant site for 2 seconds (Figure 12). The actual switching occurs when the magnet is withdrawn. The magnet On/Off control circuit does not affect programmed parameters; when the output is switched On using the magnet, the output resumes its previously programmed waveform and stimulation mode.

Figure 12. Magnet properly positioned over neurostimulator.

The magnet control circuit can be disabled with the clinician programmer software. Patients who are exposed to magnets or strong electromagnetic fields may experience unexpected On/Off switching of their neurostimulators. If On/Off switching occurs, you can disable the magnet control circuitry with a command to the neurostimulator from the clinician programmer. The magnet control circuit can later be enabled with another command from the clinician programmer, if desired. Detailed instructions on this disable feature

Magnet

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are contained in the programming guide provided with the clinician programmer.

Neurostimulator Counters

Patient Activations – Each time the neurostimulator is turned On, the activation is counted on the Patient Activation Counter. This counter will count up to 32,767 patient activations, and it can be read by telemetry and reset by a special programming command.

Total Stimulation Time – The total stimulation time is the amount of time the neurostimulator is On (with amplitude > 0) since the counter was last reset. It is a cumulative total with a counter capacity of 8,738 hours, or approximately 1 year. If cycling is programmed, Off cycle time is included.

Elapsed Time – The elapsed time is the amount of total time since the counters were last reset. The capacity of this counter is 8,192 hours, or approximately one year.

Counter Reset – All counters can be reset with the clinician programmer.

Postoperative Patient Management

The treating clinician(s) should be experienced in all aspects of the medical management of patients with Parkinson’s disease. Clinicians using Activa Therapy for the first time are encouraged to contact a Medtronic representative for information on the postoperative management of Activa patients.

When programming stimulation parameters, give consideration to the following programming recommendations regarding initial stimulation parameters.

# Caution: If the On or Off control by the magnet-actuated reed switch is disabled, the patient must have a therapy controller to turn the neurostimulator on or off.

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Programming Initial Stimulation Parameters for Activa Parkinson’s Control Therapy – The following procedure provides instructions on programming post-operative stimulation parameters for Activa Parkinson’s Control Therapy, and is one approach for the physician’s consideration.

Notes:■ High amplitude/pulse width combinations can result in

excessive charge density. Refer to “Programming Stimulation Parameters” on page 49 for more information.

■ With the Kinetra Model 7428 Neurostimulator operating in a dual-program configuration, select stimulation parameters for Program 1 (Lead 1) and Program 2 (Lead 2).

■ If independent rate control is desired to provide adequate symptom control for your patient, be aware that rate parameter values are not independently programmable with the Kinetra Model 7428 neurostimulator.

1. Allow sufficient time for the patient to recover from surgery. Schedule the initial programming visit so that the patient is in an “off” period, when the Parkinson’s disease symptoms are predominant.

2. Set the neurostimulator to the initial settings provided in Table 3.

3. To evaluate the potential effectiveness of all electrodes, select a predominant Parkinson’s disease symptom, such as rigidity or tremor, that responds to changes in stimulation.

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Table 3. Programming Settings for Activa Parkinson’s Control Therapy.

Parameter Typical Initial

Setting

Range/Options Typical Final Setting

Amplitude 0.0 V Normal: 0-10.5 VFine: 0-6.35 V

2.5-3.5 V

Pulse Width 60-120 µsec 60-450 µsec 60-120 µsec

Ratea

a The same value for rate is programmed for both Program 1 and Program 2.

130-160 pps 3-250 pps 130-185 pps

Electrode Polarity (Refer to “Electrode Programming Configurations” on page 53)

Unipolar Unipolar or

Bipolar

Variesb

b In the Medtronic-sponsored clinical investigation, most STN patients used unipolar stimulation, whereas similar proportions of GPi patients used unipolar and bipolar stimulation.

Mode Continuous Cycling or Continuous

Continuous

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4. To expedite electrode selection, program the neurostimulation system to a unipolar electrode configuration where the neurostimulator case is the positive electrode, electrode 0 is the negative electrode for Program 1, and electrode 4 is the negative electrode for Program 2.Note: It may be desirable to ultimately program the neurostimulation system to a bipolar electrode configuration, where both the positive and negative electrical poles are the lead electrodes. This can reduce the potential for electromagnetic interference-related side effects, and may optimize battery life.

5. Gradually increase amplitude by 0.1 - 0.5 V incrementally until a predominant Parkinson’s disease symptom (rigidity, tremor) is suppressed. Wait a few minutes to assess the effect of stimulation.

6. If there is uncomfortable stimulation or inadequate symptom suppression, reduce the amplitude to 0 V and select another electrode as the negative electrode. Repeat step 5. Select the electrode that provides the best control of symptoms with the fewest side effects.

7. After the most desirable negative electrode is selected, gradually increase the amplitude until side effects occur. The therapeutic window between symptom suppression and occurrence of side effects should be sufficiently wide to allow for future amplitude adjustments.

8. Evaluate the patient in an “on” period, when Parkinson’s disease symptoms are controlled after a usual dose of antiparkinsonian medication. Assess the effect of stimulation on suppressing or worsening of dyskinesias.

9. After Amplitude settings are determined, adjust Pulse Width and Rate to improve therapeutic benefit and minimize side effects.

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Notes:■ Symptom suppression is desirable at the lowest possible

amplitude, rate, and pulse width in order to improve battery longevity and minimize charge density.

■ The same value for rate is programmed for both Program 1 and Program 2.

10. Document final parameter settings for future reference.

Programming Stimulation Parameters

When programming stimulation parameters, give consideration to the following recommendations regarding high output interlocks and charge density.

High Output Interlocks – Certain combinations of high amplitude, pulse width, and rate stimulation settings are not allowed by the clinician programmer. If you attempt to program a parameter value (or limit) that will cause the settings to exceed the high output interlock limit, the desired parameter value can only be achieved by reducing one of the other parameter values. Refer to Table 4 for information on limited amplitude at high programmed rate and pulse width combinations.

Note: If the upper limit for amplitude, pulse width, or rate is programmed to a higher value than the programmed value, the programmer will use this value when determining a high output interlock.

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Charge Densities – 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 (Figure 13).

The device’s maximum amplitude is 10.5 V, and maximum pulse width is 450 microseconds. The curved lines in Figure 13 represent a charge density of 30 microcoulombs/cm2/phase at various impedance measurements, calculated for the electrode surface area of the DBS Model 3387/3389 Lead. Mean resistance found in the clinical studies were as follows.

■ 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).

Table 4. Maximum Programmable Amplitude at High Rate/Pulse Width Combinations.

Programmed Limited Amplitude at High Rates (Hz)

PW (µsec) 130 150 175 200 220 250

90 10.5 V 10.5 V 10.4 V 9.9 V 9.5 V 9.1 V

120 10.4 V 10.0 V 9.5 V 9.0 V 8.6 V 8.1 V

180 9.2 V 8.7 V 8.1 V 7.6 V 7.0 V 6.4 V

240 8.3 V 7.7 V 7.1 V 6.6 V 6.0 V 5.5 V

300 7.3 V 6.8 V 6.2 V 5.7 V 5.4 V 5.0 V

360 6.8 V 6.2 V 5.6 V 5.0 V 4.7 V 4.3 V

420 6.4 V 5.9 V 5.3 V 4.8 V 4.5 V 4.1 V

450 6.0 V 5.5 V 4.8 V 4.2 V 3.8 V 3.4 V

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■ 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 of Figure 13 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 application manual for further information).

Figure 13 includes two examples of charge density calculated for the Activa System. In Example A, the Kinetra Model 7428 Neurostimulator is set to typical parameter settings for symptom suppression: amplitude = 3.0 V and pulse width = 90 µsec. The charge density for 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 13, if the impedance in this case is at the clinical mean from the Parkinson’s disease clinical study, the charge density would be below 30 microcoulombs/cm2/phase.

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Figure 13. Charge density with Parkinson’s disease clinical mean resistance.

Am

plit

ud

e (V

olt

s)

Pulse Width (Microseconds)

DBS Amplitude and Pulse Width LimitsComputed for resistances ranging from 500 to 2,000 ohms

DBS Lead Surface Area = 0.06 cm2

Charge Density Threshold = 30 Microcoulombs/cm2/phase

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Electrode Programming Configurations

The Kinetra Neurostimulation System offers two types of configurations: unipolar (neurostimulator case positive, lead electrode(s) negative) and bipolar (neurostimulator case off, one or more lead electrodes positive and one or more lead electrodes negative). In addition, by selecting and activating different combinations of electrodes available for the neurostimulation system, the stimulation can be tailored to individual patient therapy requirements.

Some of the advantages and disadvantages of the configurations are discussed below. When selecting the configuration, check the impact on battery life. For more information on battery longevity, refer to “Appendix: Battery Longevity Reference Information” on page 64.

For more information on the leads or the extensions, refer to the technical manual packaged with the product.

Bipolar Configurations – In a bipolar configuration, at least one lead electrode is positive and at least one lead electrode is negative, with the neurostimulator case Off. Using a bipolar configuration with one negative lead electrode and one positive electrode may maximize battery life.

w Warning: Use only leads that are compatible with the output capabilities of the neurostimulator. Refer to the system components sheet.

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Unipolar Configurations – In a unipolar configuration, one or more lead electrodes are negative and the neurostimulator case is positive. Check the effect on battery life. Refer to “Appendix: Battery Longevity Reference Information” on page 64.

Note: Activating more than the minimum number of electrodes in either unipolar or bipolar configurations spreads the stimulation over a greater area, but may reduce the battery life. Activate additional electrodes only after other electrode combinations have been tried. However, check the effect on battery life. For more information on battery longevity, refer to “Appendix: Battery Longevity Reference Information” on page 64.

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Figure 14. Electrode Configuration.

Front

Back

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Test Stimulation

An intraoperative test stimulation phase during the lead implant procedure verifies a correct lead placement that results in symptom suppression with minimal side effects. Perform test stimulation intraoperatively. If there is no symptom suppression, do not implant the Activa System. Instructions for the test stimulation are included in the DBS Lead Implant Manual and the Model 3625 Test Stimulator Operator Manual.

Specifications and Features

The Kinetra Neurostimulator is powered by a hermetically sealed, silver vanadium oxide cell and uses integrated circuits. To protect the neurostimulator components from intrusion of body fluids, the electronics and power source are hermetically sealed within an oval-shaped titanium shield.

Refer to Table 5 for a list of the parameter operating ranges, to Table 6 for parameter settings at shipping, and to Table 7 for the physical characteristics of the neurostimulator. The Kinetra Model 7428 Neurostimulator case has an external insulating coating to help minimize possible skeletal muscle stimulation at the neurostimulator implant site. An uninsulated area on one side of the neurostimulator (etched identification side) can serve as the positive electrode when using a unipolar configuration. The uninsulated side should be positioned outward, away from muscle tissue, toward the exterior of the body.

Kinetra neurostimulators have a self-sealing connector assembly with a corrosion-resistant titanium-alloy body and titanium setscrews. This connector assembly can accommodate two extensions to form a dual-program system. Securing the extension requires the use of the hex wrench that is packaged with the neurostimulator.

Other features of Kinetra neurostimulators include: two suture holes to enable you to secure the neurostimulator within the subcutaneous pocket; Power On Reset (POR); and a radiopaque identification code.

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Table 5. Kinetra Model 7428 Neurostimulator Programmable Parameter Values.

Programmable Parameters

Valuesa

Pulse Amplitude b and Limits for Programs 1 and 2

Normal resolution: 0 to 10.5 V (0.1 V steps)Fine Resolution: 0 to 6.35 V (0.05 V steps)

Rate and Limitsb,c 66 values from 3 to 250

Pulse Width and Limits for Programs 1 and 2b

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

Cycle On Time 0.1 second to 24 hours

Cycle Off Time 0.1 second to 24 hours

Cycle On Timew/SoftStart

2 seconds to 24 hours

Cycle Off Timew/SoftStart

2 seconds to 24 hours

SoftStart/Stop 1, 2, 4, or 8 seconds

Electrode Polarity for Program 1

0, 1, 2, 3, Electrodes: Off, Neg or PosCase: Off or Pos

Electrode Polarity for Program 2

4, 5, 6, 7, Electrodes: Off, Neg or PosCase: Off or Pos

Day Cycling ON Time 30 minutes to 24 hoursd

Day Cycling OFF Time

30 minutes to 24 hoursd

Magnet ON/OFF Control Circuit

Enabled or Disabled

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a Note: All values are approximate.b Note: Certain combinations of amplitude, pulse width, and rate are not allowed. Refer

to “High Output Interlocks” on page 49.c The same values for rate and rate limits are programmed for both Program 1 and

Program 2.d The sum of the ON and OFF times must equal 24 hours.

Table 6. Kinetra Model 7428 Neurostimulator Shipping Settings.

Description Value

Amplitude for Programs 1 and 2 (Normal Resolution)

Upper LimitLower Limit

0 volts

+0 volts tracking-0 volts tracking

Rate for Programs 1 and 2Upper LimitLower Limit

130 pps+0 pps tracking-0 pps tracking

Pulse Width for Programs 1 and 2Upper LimitLower Limit

90 µsec+0 µsec tracking-0 µsec tracking

Output On/Off Switch Offa

Mode Continuous Dual-Program

SoftStart/Stop 4 seconds

Magnet Control Circuit Enabled

Electrode Polarity for Program 1 0 = Negative1 = Off2 = Off3 = PositiveCase = Off

Electrode Polarity for Program 2 4 = Negative5 = Off6 = Off7 = PositiveCase = Off

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a Note: Exposure to a strong source of electromagnetic interference (EMI) can cause the output switch to toggle to the On position. However, since the Amplitude setting is 0.0 V, there is no neurostimulator output.

Table 7. Kinetra Model 7428 Neurostimulator Physical Description.

Description Valuea

Height 2.4 in. (61 mm)

Length 3.0 in. (76 mm)

ThicknessCaseConnector

0.527 in. (13.4 mm)0.590 in. (15.0 mm)

Weight 2.9 oz (83 g)

Volume 3.1 in3 (51 cm3)

External Shield Titaniumb

Storage Temperature -18° C to +55° C0° F to +131° F

a All values are approximate.b Note: The Kinetra Model 7428 Neurostimulator has an insulating coating to prevent

undesirable muscle stimulation. The uninsulated side with the etched identification should be positioned outward, away from the muscle.

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Kinetra Neurostimulator Battery Longevity

“Appendix: Battery Longevity Reference Information” on page 64 in this manual can be used to help you estimate battery longevity for the Kinetra Neurostimulator at various parameter settings. The fewer the number of stimulation hours used daily, the longer the total longevity.

The battery information provided in the appendix is theoretical. In actual use, parameters, usage time, and other factors such as impedance, may vary. Therefore, the tables and formulas cannot predict precise longevity for any given patient. However, once battery life is estimated, it is possible to set realistic expectations of battery life and achieve optimal battery life from the Kinetra Neurostimulator.

Note: Battery life estimates are for a new implant and therefore should be made at the time of implant.

Battery Status Indicators

The clinician programmer enables you to monitor your patient’s neurostimulator battery status. The programmer provides both voltage and current measurements. For example, as the neurostimulator battery depletes, the telemetry readout will show LOW on the programmer’s display. If you use the printer, it will print LOW. As the battery voltage decreases further, the clinician programmer shows the battery status as EOL (End of Life) on the display, or prints EOL. After the neurostimulator battery has been depleted, telemetry is no longer possible. Refer to the table below for a summary of battery status messages and their meaning.

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In addition to the neurostimulator battery status, the programmer can measure the battery voltage (volts), stimulation current (µamps), and battery capacity.

It is recommended that stimulation current and impedance measurements be taken after every programming session with your patient. This information can be valuable at a later time if a malfunction develops. The measurements can be used to troubleshoot and isolate the problem.

For example, measurements that show a significant reduction in stimulation current (or increase in impedance) can indicate a fractured lead conductor, a loose setscrew, and so forth. Conversely, a significant increase in stimulation current (or decrease in impedance) can indicate shorted conductors, a break in lead insulation, and so forth. In either case, it is very useful to know what the settings were when the system was operating properly.

The battery capacity measurement calculates the voltage of the neurostimulator battery and the percentage of battery capacity consumed.

Note: The neurostimulator must be Off to perform this measurement.

Battery Status Indicators Battery Voltage Level

OK Battery voltage is OK

Low Battery voltage is approaching EOL (5-15% remaining capacity)a

a Schedule replacement surgery immediately.

EOL (End-of-Life) Battery voltage is near depletion (<5% remaining capacity)a

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Battery Depletion

As the neurostimulator battery nears total depletion the output will gradually decrease and then vanish completely when the neurostimulator automatically shuts itself down.

Notes:■ When the neurostimulator battery reaches Low status, the

neurostimulator battery light on the therapy controller blinks when the patient interrogates the device. Patients should be instructed to contact their physician.

■ The clinician programmer calculates battery capacity remaining, so the physician can schedule neurostimulator replacement based on the patient settings and remaining battery capacity1.

Power On Reset

As a safety feature, each time there is a temporary interruption in battery output, the neurostimulator will automatically reset to zero amplitude and output Off, the electrodes and case will reset to Off, and the serial number will be lost. This could be caused, for example, by use of an electrocautery tip near the neurostimulator or by defibrillation. To restore stimulation, turn the neurostimulator On and program the neurostimulator to the previously programmed parameter values.

# Caution: Patients may experience a decrease in symptom suppression as the battery nears total depletion. Patients should be instructed to contact their clinician.

1 If the remaining battery capacity is 15% or less, schedule replacement surgery immediately.

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X-Ray Identification

X-ray identification permits the determination of manufacturer and neurostimulator model number. With standard x-ray procedures, the code inside the connector block appears as white characters. The Medtronic symbol identifies Medtronic as the manufacturer. For the Kinetra Model 7428 Neurostimulator, the designated letters are NFD (Figure 15).

Figure 15. X-ray identification location.

How Supplied

The Kinetra Model 7428 Neurostimulator package contains the following:

■ One Model 7428 Neurostimulator■ One Hex Wrench■ Product Literature

Note: The contents of the inner package are STERILE.

The neurostimulator and accessories contained in the package are intended for Single Use Only.

Neurostimulator Connector Block

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Appendix: Battery Longevity Reference Information

With the Kinetra neurostimulator, you can expect battery life to range from months to years, depending on the parameters you have selected for your patient and the patient’s use of the system. This appendix provides reference information that will assist you in estimating Kinetra battery longevity prior to neurostimulator internalization and maximize battery life during use. It contains the procedure, tables and formulas needed to estimate battery longevity plus tips for maximizing battery life. These estimates are based on programmed parameters and correction factors for electrode selection and expected usage time. However, actual battery life will vary due to other factors such as impedance, changes in stimulation requirements over time, amount of stimulation use, and stimulation parameters selected within the programmed limits for amplitude, rate, and pulse width.

Tips for Maximizing Battery Life

The following tips will help optimize Kinetra battery life:■ Use the minimum number of active electrodes necessary for

effective stimulation.■ Use bipolar stimulation. Keeping all other programmed

settings constant, changing to bipolar stimulation provides longer battery life than unipolar stimulation.

■ Use the lowest effective settings and upper limits for amplitude, rate, and pulse width.

Estimating Battery Life Prior to Neurostimulator Internalization

Follow this procedure to estimate Kinetra battery life prior to neurostimulator internalization. Use the worksheet on page 68 to record settings and calculate longevity.

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1. Determine the expected Program 1 operating parameters for the neurostimulator, including Amplitude, Rate, Pulse Width, number of active electrodes, cycle ON/OFF times, and hours of stimulation per day.

2. Determine the Program 1 Energy Use (EU) from Table 8 (page 71) using the expected values for amplitude, rate, and pulse width.Notes:■ Use the table values that are closest to the expected

values. Be aware that when values do not match, there will be a discrepancy between calculated longevity estimates and actual results.

■ Table 8 assumes neurostimulator usage of 24 hours per day. If neurostimulator usage is different from that, adjustments will be made in later calculations.

3. Determine the Program 1 Electrode Correction Factor (ECF) from Table 9 (page 72) for the number of active electrodes.Note: If selecting an electrode configuration for this program with only one positive and only one negative electrode (bipolar), you may skip step 3 because the Electrode Correction Factor is 1.0.

4. Multiply the Program 1 Energy Use by the Program 1 Electrode Correction Factor to obtain the Program 1 Factor (P1F).

5. Repeat steps 1 through 4 for Program 2 to obtain the Program 2 Factor (P2F).

6. Add the Program 1 Factor and the Program 2 Factor to obtain the Dual-Program Factor (DPF).

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7. Determine the Usage Correction Factor (UCF) from the following formula (the value will be between 0 and 1):Usage Correction Factor = Usage Ratio x Cycling Ratio[Usage Ratio = hours of stimulation (per day) ÷ 24 hours][Cycling Ratio = cycle On ÷ (cycle On + cycle Off)]Notes:■ If Cycling is not programmed, the formula becomes:

Usage Correction Factor = Usage Ratio ■ If using Continuous mode with 24 hours of stimulation, you

may skip step 7 because the Usage Correction Factor is 1.0.

8. Multiply the results of steps 6 and 7 to obtain the adjusted Energy Use value:DPF x UCF = adjusted Energy Use

9. Finally, take the adjusted Energy Use value and determine the estimated battery longevity in years from Table 10 (page 73).

Example

Assume the patient’s neurostimulator will be programmed to these settings:

Amplitude: Program 1 = 2.7 V; Program 2 = 3.0 VRate (for Programs 1 and 2) = 185 HzPulse Width: Program 1 = 60 µsec; Program 2 = 120 µsecElectrodes: Program 1 bipolar = 1 +, 2 –, remaining Off;Program 2 bipolar = 5 +, 6 –, 7 – and 4 OffContinuous modeHours of Stimulation = 16 hours

The Energy Use from Table 8 (page 71) would be 59 for Program 1 and 114 for Program 2.

The Electrode Correction Factor from Table 9 (page 72) would be 1.0 for Program 1 and 1.3 for Program 2.

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Thus, the Program 1 Factor would be 59 x 1.0 = 59,and the Program 2 Factor would be 114 x 1.3 = 148.2,making the Dual-Program Factor 59 + 148.2 = 207.2.

The Usage Correction Factor would be:Usage Ratio = 16 ÷ 24 = 0.66Usage Correction Factor = Usage Ratio = 0.66

The adjusted Energy Use would be: 207.2 x 0.66 = 136.8

And the estimated battery longevity from Table 10 (page 73) would be 5 years.

To show how small changes in parameter settings can have a big impact on battery longevity, consider this alternate example:

All settings remain the same except the electrode configuration for both programs is changed to unipolar (case +) with 2 active electrodes.The Electrode Correction Factor for both programs would be 2.8. This would result in an adjusted Energy Use of 319.7 instead of 136.8, and a longevity estimate of 2.3 years instead of 5 years.

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Battery Longevity Worksheet

Program 1 Energy Use (P1 EU)

The Program 1 Energy Use (EU) from Table 8 on page 71 is: ______

Program 1 Electrode Correction Factor (P1 ECF)

If the electrode configuration for Program 1 is one positive and one negative electrode, skip this step. Otherwise, the Program 1 Electrode Correction Factor (ECF) from Table 9 on page 72 is: ______

Program 1 Factor (P1F)

Compute the Program 1 Factor:(P1 EU) _____ x (P1 ECF) _____ = _____ (P1F)

Program 2 Energy Use (P2 EU)

The Program 2 Energy Use (EU) from Table 8 on page 71 is: ______

Amp ______ V Rate ______ Hz PW ______ µsec

Amp ______ V Rate ______ Hz PW ______ µsec

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Program 2 Electrode Correction Factor (P2 ECF)

If the electrode configuration for Program 2 is one positive and one negative electrode, skip this step. Otherwise, the Program 2 Electrode Correction Factor (ECF) from Table 9 on page 72 is: ______

Program 2 Factor (P2F)

Compute the Program 2 Factor:(P2 EU) _____ x (P2 ECF) _____ = _____ (P2F)

Dual-Program Factor (DPF)

Compute the Dual-Program Factor:(P1F) _____ + (P2F) _____ = _____ (DPF)

Usage Correction Factor

If using Continuous mode with 24 hours of stimulation, skip this step. Otherwise, calculate the Usage Correction Factor as follows:

Hours of stimulation (per day): _____ hours

Cycle On time: _____

Cycle Off time: _____

Compute the Usage Ratio:_____ hours of stimulation ÷ 24 hours = _____

And the Cycling Ratio:

_____ cycle On ÷ (_____ cycle On + _____ cycle Off) = _____

With the Usage Ratio (UR) and the Cycling Ratio (CR), compute the Usage Correction Factor (UCF):

(UR) _____ x (CR) _____ = _____ (UCF)

Or if Cycling is not used:(UR) _____ = _____ (UCF)

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Longevity Estimate

Now calculate the adjusted Energy Use:

(DPF) _____ x (UCF) _____ = _____ (adjusted EU)

The estimated battery longevity from Table 10 on page 73 is:__________ years

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Table 8. Kinetra Neurostimulator Energy Use for 2 Active Bipolar Electrodes per Program for 24 Hours/Day Usage.

Pulse Width

Amplitude Rate 60 120 210 450

1.0

130185250

101419

182634

294355

5882

103

2.0130185250

253749

497193

84120155

169237300

3.0130185250

415977

81114148

137195249

276383481

4.0130185250

74103134

142200259

241338434

484665N/A

5.0130185250

113159207

219309397

374522666

749N/AN/A

6.0130185250

162227292

315441564

536743N/A

1073N/AN/A

7.0130185250

222312400

432603774

7351020N/A

N/AN/AN/A

8.0130185250

293409524

5697951013

968N/AN/A

N/AN/AN/A

9.0130185250

376523664

7311014N/A

N/AN/AN/A

N/AN/AN/A

10.0130185250

480673856

933N/AN/A

N/AN/AN/A

N/AN/AN/A

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Note: N/A in Table 8 refers to values that are not allowed by the clinician programmer. Refer to “High Output Interlocks” on page 49.

Table 9. Kinetra Neurostimulator Electrode Correction Factor (ECF).

Electrode Configuration Electrode Correction Factor

Bipolar

1 Negative, 1 Positive 1.0

1 Negative, 2 Positive 1.3

1 Negative, 3 Positive 1.5

2 Negative, 1 Positive 1.3

2 Negative, 2 Positive 1.8

3 Negative, 1 Positive 1.5

Unipolar

1 Negative, Case Positive 1.8

2 Negative, Case Positive 2.8

3 Negative, Case Positive 3.5

4 Negative, Case Positive 4.2

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Table 10. Kinetra Neurostimulator Longevity Estimates (Years) for Energy Use (EU).

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Glossary

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Glossary

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

Interference – Anything that reduces the effectiveness of the neurostimulator or a programming transmission.

Mode – The type of stimulation that can be programmed.

Parameter, Programmable – A specific function with an operating range of selectable values (i.e., Rate, Pulse Width) that enables the tailoring of neurostimulation therapy for a patient.

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

Rate – A measure, in pulses per second (or Hz), that provides the number of times stimulating pulses are delivered each second.

SoftStart/Stop Stimulation – The SoftStart/Stop feature that allows stimulation to begin with a ramped output (e.g., it is designed to prevent a sudden “burst” of stimulation when the neurostimulator turns On normally). This is done by gradually increasing the amplitude of the stimulating pulses up to the programmed value. The SoftStart/Stop feature also causes a gradual decrease of the amplitude of stimulation back down to zero when the neurostimulator output is turned Off, or when the Off cycle begins.

Telemetry – A radiofrequency type of communication.

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