Abbott 3875 User manual
St. Jude Medical™ Patient
User's Guide
Controller
For Deep Brain Stimulation Systems
Model 3875
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.
‡ Ind
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
Pat.
©
icates a third-party trademark, which is property of its respective owner.
http://www.abbott.com/patents
2020 Abbott. All Rights Reserved.
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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
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Wireless Technology Information ....................... 95
Radio Transmitter, Cables, Transducers ............ 97
Quality of Service for Wireless Technology ......... 98
1
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
General > About > Legal > Regulatory.
Settings >
2
Symbol
Definition
continuous operation.
required.
Table 1. Symbols and definitions
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
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
3
Symbol
Definition
Magnetic Resonance (MR) Unsafe, an item
MR environment
device.
Table 1. Symbols and definitions
poses unacceptable risks to the patient,
medical staff, or other persons within an
Device contains a radio-frequency (RF)
transmitter, which may cause RF
interference with other devices near this
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
4
Symbol
Definition
barrier or its packaging is compromised
Table 1. Symbols and definitions
Temperature limits for storage conditions
Humidity limits
Pressure limits
Manufacturer
Do not use if the product sterilization
Contents quantity
Programmer
Accessories
Serial number
Batch code
Unique Device Identification
Prescription use only
5
Symbol
Definition
By ensuring that this product is disposed of
Abbott Medical.
of this directive.
Table 1. Symbols and definitions
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.
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
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
Authorized European representative
6
Symbol
Definition
Compliance Mark (RCM)
the Japan Radio Law
Table 1. Symbols and definitions
Australian Communications and Media
Authority (ACMA) and New Zealand Radio
Spectrum Management (RSM) Regulatory
This equipment is certified for type
certification pursuant of Article 38-24 of
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.
7
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.
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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.
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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.
10
If the programming of stimulation parameters exceeds
2
the charge density limit of 30 μC/cm
, 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.
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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.
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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
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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
14
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.
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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).
16
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;
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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.
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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
19
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
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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
21
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.
22
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
23
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
24
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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