Abbott 3875 User manual

St. Jude Medical™ Patient

Controller

For Deep Brain Stimulation Systems

Model 3875

USER'S GUIDE

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

™ Indicates a trademark of the Abbott group of companies.

‡ Indicates a third-party trademark, which is property of its respective owner. Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc. Pat. http://www.abbott.com/patents

Contents
About This Guide......................................................	1
Symbols and Definitions ......................................	1
Terms Used in This Document ............................	6
Prescription and Safety Information ..........................	7
Intended Use ......................................................	7
Indications for Use ..............................................	7
Contraindications ................................................	8
MRI Safety Information........................................	8
Warnings.............................................................	9
Precautions.......................................................	15
Adverse Effects .................................................	23
Patient Expectations..........................................	28
Product Description................................................	30
About Your System............................................	31
Overview of the Patient Controller ......................	33
Items You Will Receive ......................................	37
Your Personal Identification Card.......................	38
Directions for Use...................................................	39
Start-up Screen .................................................	39
Overview of the Therapy Screen ........................	41
Starting and Stopping Stimulation......................	45
Mode ................................................................	47
Using the Surgery Mode Feature .......................	49
Using the MRI Mode Features...........................	52
Viewing and Selecting a Program.......................	57
Adjusting Strength.............................................	60
System Information ...........................................	63
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Additional Patient Controller Information .................	66
Maintaining the Generator and Patient Controller ....	67
Checking the Generator Battery Status ..............	67
Checking the Patient Controller Battery Status ...	68
Caring for the Patient Controller.........................	69
Cybersecurity .........................................................	70
Protecting Access to the Patient Controller.........	70
Wireless Security Measures ...............................	71
Guidelines for Secure Use .................................	72
Troubleshooting......................................................	73
Troubleshooting Messages for MRI Mode ..........	85
Technical Support ..................................................	88
Appendix A: Downloading the Patient Controller
App .....................................................................	89
Appendix B: Pairing the Patient Controller to the
Generator ............................................................	91
Appendix C: Regulatory Statements ........................	92
Statement of FCC Compliance ...........................	92
Statement of Compliance With License-Exempt
RSS Standard (Canada)..................................	94
Declaration of Conformity (Industry Canada)
Notice to Users of Radio and Television ..........	94
Identification Information for Product
Registration ....................................................	94
Product Classification Statement (CISPR 11,
Class B)..........................................................	95

Wireless Technology Information .......................	95
Radio Transmitter, Cables, Transducers ............	97
Quality of Service for Wireless Technology .........	98

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About This Guide

This guide explains how to use the St. Jude Medical™ Patient Controller application (Model 3875) with your neurostimulation system. If you have any questions about your system, contact Technical Support.

Symbols and Definitions

The following symbols may be used in this document and on some of the products and packaging:

NOTE: For symbols and definitions for the patient controller, refer to the user guide available at support.apple.com/manuals for the Apple‡ iOS‡ device you are using to run the patient controller app; or, on the patient controller Home screen, tap Settings > General > About > Legal > Regulatory.

Table 1. Symbols and definitions

Symbol Definition

Caution, consult accompanying documents

Consult this document for important safetyrelated information (This symbol is blue and white on the device.)

Consult instructions for use

Follow instructions for use on this website

Device contains a type BF applied part to protect you from shock. The device is internally powered and is intended for continuous operation.

Magnetic Resonance (MR) Conditional, an item with demonstrated safety in the MR environment within the defined conditions. At a minimum, address the conditions of the static magnetic field, the switched gradient magnetic field, and the radiofrequency fields. Additional conditions, including specific configurations of the item, may be required.

Table 1. Symbols and definitions

Symbol Definition

Magnetic Resonance (MR) Unsafe, an item poses unacceptable risks to the patient, medical staff, or other persons within an MR environment

Device contains a radio-frequency (RF) transmitter, which may cause RF interference with other devices near this device.

Keep dry

Ingress protection rating for a device that is protected from the intrusion of solid foreign objects as small as 12.5 mm in diameter and is protected from vertically dripping water when the device is tilted at an angle up to 15 degrees

Expiration date

Date of manufacture

Catalog number

Manufacturing facility

Table 1. Symbols and definitions

Symbol Definition

Temperature limits for storage conditions

Humidity limits

Pressure limits

Manufacturer

Do not use if the product sterilization barrier or its packaging is compromised

Contents quantity

Programmer

Accessories

Serial number

Batch code

Unique Device Identification

Prescription use only

Table 1. Symbols and definitions

Symbol Definition

This product shall not be treated as household waste. Instead it is the user’s responsibility to return this product to Abbott Medical for reprocessing.

By ensuring that this product is disposed of properly, you will help prevent potential negative consequences for the environment and human health, which could be caused by inappropriate waste handling of this product. The recycling of materials will help to conserve natural resources.

For more information about how to return this product for recycling, please contact Abbott Medical.

Authorized European representative

European conformity, affixed in accordance with the relevant provisions of AIMD directive 90/385/EEC. Hereby, Abbott Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive.

Table 1. Symbols and definitions

Symbol Definition

Australian Communications and Media

Authority (ACMA) and New Zealand Radio

Spectrum Management (RSM) Regulatory

Compliance Mark (RCM)

This equipment is certified for type certification pursuant of Article 38-24 of the Japan Radio Law

Terms Used in This Document

This section contains definitions of some of the terms used in this document.

Magnetic Resonance (MR) Conditional system. A group of implanted parts that allows a patient to receive a magnetic resonance imaging (MRI) scan safely if all the requirements for the implanted parts and for scanning are met.

Program. A combination of stimulation parameters that are set to get a desired therapeutic effect.

Stimulation parameter. A setting that is part of a complete program.

Prescription and Safety Information

Read this section to gather important prescription and safety information.

Intended Use

This neurostimulation system is designed to deliver electrical stimulation to targets in the brain. The

St. Jude Medical™ Patient Controller app is intended to be used as part of the system to help the patient manage prescribed stimulation programs.

Indications for Use

This system is indicated for the following conditions:

Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications.

Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.

Contraindications

This system is contraindicated for patients who meet the following criteria:

Are unable to operate the system

Have unsuccessful test stimulation

The following procedures are contraindicated for patients with a deep brain stimulation system. Advise patients to inform their healthcare professional that they cannot undergo the following procedures:

Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy)

Electroshock therapy and transcranial magnetic stimulation (TMS)

MRI Safety Information

You may be implanted with the parts that make up a Magnetic Resonance (MR) Conditional system, which allows you to receive an MRI scan if all the requirements for the implanted parts and for scanning are met. Scanning under different conditions may cause device malfunction, severe injury, or death. Contact your physician before receiving an MRI scan to find out if you can undergo the procedure and to learn more about any risks. Additionally, before receiving an MRI scan, inform the healthcare professional that you are implanted with a neurostimulation system. If you do not have an MR Conditional system, you cannot receive an MRI.

Do not bring your patient controller into the scanner magnet room. It can be affected by the MRI magnet, may present a projectile hazard, and is MR Unsafe.

For more information about what you need to do to prepare for an MRI scan, refer to "Using the MRI Mode Features" (page 52) in this guide.

Warnings

The following warnings apply to these components.

NOTE: For nontherapy-related warnings regarding the St. Jude Medical™ Patient Controller, refer to the user guide available at support.apple.com/manuals for the Apple‡ iOS‡ device you are using to run the patient controller app.

System Warnings

Pregnancy and nursing. Do not use the neurostimulation system if you are pregnant or nursing.

High stimulation outputs and charge density limits. Avoid excessive stimulation. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths.

High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The system can be programmed to use parameter settings outside the range of those used in the clinical studies.

If the programming of stimulation parameters exceeds the charge density limit of 30 μC/cm2, a screen will appear warning you that the charge density is too high. Charge density can be reduced by lowering the stimulation amplitude or pulse width. For more information, contact your physician.

Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet.

Risk of depression, suicidal thoughts, and suicide. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Suicidal thoughts, suicide attempts, and suicide are events that have also been reported. Patients and caregivers should consider the following:

Before the procedure, be sure you talk to your treating physician(s) if you have a history of depression, suicidal thoughts, or have attempted suicide. Be sure you understand the possible risks of new onset or worsening depression (including suicidal thoughts) as well as the potential clinical benefits of DBS therapy.

After the procedure, if you notice unusual changes in mood or behavior (such as increased anxiety, sleeping problems, loss of interest in activities, feeling of hopelessness, mood swings, weight loss or weight gain), or impulse control, contact your physician. If you are having thoughts of suicide, contact your physician or emergency services immediately.

It is important to attend on-going follow-up visits with your physician to manage your therapy.

Operation of machinery and equipment. Do not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if your symptoms were to unexpectedly return.

Device components. The use of components not approved for use by Abbott Medical may result in damage to the system and increased risk to the patient.

Electrosurgery devices. Electrosurgery devices may harm you or damage your neurostimulation system. If you need to receive a procedure using an electrosurgery device, place your generator in Surgery Mode. Your physician may only use bipolar electrosurgery devices and they should keep the device as far away from your neurostimulation system as possible. Additionally, they must confirm the neurostimulation system is functioning correctly after your procedure.

Radiofrequency or microwave ablation. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.

Implanted cardiac devices. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator.

Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.

Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of

neurostimulator. Conversely, the other active implanted device may interfere with operation of the neurostimulation system.

Case damage. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals.

Cremation. The IPG should be explanted before cremation because the IPG could explode. Return the explanted IPG to Abbott Medical.

Low frequencies. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). For this reason, programming at frequencies less than 30 Hz is not recommended.

Return of symptoms and rebound effect. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). In rare cases, this can create a medical emergency.

Emergency procedures. Designate a representative (family member or close friend) to notify any emergency medical personnel of your implanted neurostimulation system if emergency care is required. You will receive an identification card to carry that will inform emergency medical personnel of

your implanted system. Use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion.

Device Warnings

Explosive or flammable gases. Do not use the device in an environment where explosive or flammable gas fumes or vapors are present, including hyperbaric chambers. Operating the device could cause it to ignite, causing severe burns, injury, or death.

Interference with other devices. This equipment can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Avoid placing equipment components directly over other electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected.

Application modification. To prevent unintended stimulation, do not modify the operating system or application in any way.

Strangulation. The cords in this system pose a strangulation risk. To avoid strangulation, be careful when using cords and keep cords out of the reach of children.

Precautions

The following precautions apply to these components.

NOTE: For nontherapy-related precautions for the St. Jude Medical™ Patient Controller, refer to the user guide available at support.apple.com/manuals for the Apple‡ iOS‡ device you are using to run the patient controller app.

General Precautions

Infection. Follow proper infection control procedures. Infections may require that the device be explanted.

Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).

Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public establishments, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Use caution when approaching such a device and request help to bypass the device. If you must go through or near a gate or doorway containing this type of device, move quickly and then check your IPG to determine if it is turned on or off.

Unauthorized changes to stimulation parameters. Do not make unauthorized changes to physicianestablished stimulation parameters.

Damage to shallow implants. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions.

Long-term safety and effectiveness. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Safety and effectiveness has not been established for patients with neurological disease other than Parkinson’s disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression;

patients under 22 years; implantation in targets other than STN or GPi for Parkinson's disease and VIM for essential tremor; patients with an active implantable device; patients requiring MRI.

Handling and Implantation

Component manipulation. Do not rub or press on implanted components through the skin. This may cause the leads to move leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection.

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

Hospital and Medical Environments

Medical tests and procedures. Before undergoing medical tests or procedures (such as therapeutic radiation or electrolysis), contact your physician to determine if the procedure will cause you injury or damage your neurostimulation system. Specifically, you should be aware that medical devices such as electrohydraulic lithotriptors, therapeutic X rays, computerized tomography (CT) scans, cobalt machines, and linear accelerators may cause damage to the electronic circuitry of an implanted neurostimulation system.

Electrical medical treatment. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting the stimulation strength to zero. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment.

High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted device. If lithotripsy must be used, do not focus the energy near the device.

Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted device.

External defibrillators. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. After defibrillation, confirm the neurostimulation system is still working.

Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation

effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Electrocardiograms. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Inaccurate ECG results may lead to inappropriate treatment of the patient.

Home and Occupational Environments

Patient activities and environmental precautions. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves.

Activities requiring excessive twisting or stretching. Patients should avoid activities that may put undue stress on the implanted components of the

neurostimulation system. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component.

Activities requiring coordination. Loss of coordination is a possible side effect of DBS therapy. You should use caution when doing activities that require coordination, even if you were able to do them before receiving therapy (for example, swimming).

Bathing. You should exercise reasonable caution when bathing.

Component manipulation by patient. Patients should avoid manipulating the implanted system components (for example, the neurostimulator, the burr hole site). This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation.

Scuba diving or hyperbaric chambers. Avoid scuba diving below 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA). Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage your

neurostimulation system. Before diving or using a hyperbaric chamber, contact your physician to discuss the effects of high pressure.

Skydiving, skiing, or hiking in the mountains. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead.

Household appliances. Household appliances that contain magnets (for example, refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off.

Therapeutic magnets. Patients should be advised to not use therapeutic magnets. Therapeutic magnets (for example, magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off.

Physician instructions. Always follow the programs and therapy instructions established for you by your physician. If you do not, the therapy may be less effective.

Patient training. Do not use your neurostimulation system until an authorized clinician has trained you how to control stimulation and safely use the system.

Magnet usage. The magnet provided with the system is a high-powered magnet intended for use solely with the system. Keep it away from watches, credit cards, computer disks, and other magnetically sensitive items to avoid damaging them. Always place the keeper bar on the magnet when not in use.

Home use. This product is intended for home use per physician instruction. To avoid damage and other potential hazards, keep this product away from children and pets.

Wireless use restrictions. In some environments, the use of wireless functions (for example, Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on.

Device Precautions

Keep the device dry. Your device is not waterproof. Keep it dry to avoid damage. Do not use the device

when engaging in activities that might cause it to get wet, such as swimming or bathing.

Handle the device with care. The device is a sensitive electronic device that can be damaged by rough handling, such as dropping it on the ground.

Control of your device. Keep your device out of the hands of children in order to avoid potential damage or unauthorized change in stimulation parameters.

Battery precaution. This device contains a lithium ion battery as well as other potentially hazardous materials. Do not crush, puncture, or burn the device because explosion or fire may result. Return it to Abbott Medical for proper disposal.

Device modification. This equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.

Adverse Effects

Deep brain stimulation potentially has the following adverse effects:

Possible surgical complications. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); subcutaneous hemorrhage or seroma; hematoma; cerebrospinal fluid leakage or cerebrospinal fluid abnormality; brain

contusion; infection or inflammation; antibiotic anaphylaxis; skin disorder; edema; persistent pain at surgery site or IPG site; erosion; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; neuropathy (nerve degeneration); hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusion—transient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; aphasia; deep vein thrombosis; complications from anesthesia; phlebitis (vein inflammation); pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc.); complications from unusual physiological variations in patients, including foreign body rejection phenomena; pneumonia, seizure or convulsions; paralysis (loss of motor function, inability to move); stroke and death.

Possible deep brain stimulation complications. Deep brain stimulation complications include, but are not limited to, the following:

Device-related complications

-Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture

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