Boston Scientific Precision Montage Owner's manual

Precision Montage™
MRI Spinal Cord
Stimulator System
Information for Prescribers
91053246-02
Content: 91114311 REV AC
Information for Prescribers
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Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information
relating to its products in order to improve their reliability or operating capacity.
Trademarks
All trademarks are the property of their respective holders.
Additional Information
For Indications and related information, see the Indications DFU. For other device-specic
information not included in this manual, labeling symbols, and warranty information, refer to the
appropriate DFU for your SCS System as listed on your Reference Guide.

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Table of Contents
Device and Product Description ..............................................................................................1
Contraindications......................................................................................................................1
Safety Information.....................................................................................................................1
Instructions for the Patient ..................................................................................................1
Instructions for the Physician ..............................................................................................8
Essential Performance .......................................................................................................8
Telemetry Information ........................................................................................................8
Sterilization .........................................................................................................................9
Electromagnetic Compatibility ..........................................................................................10
Technical Service ..............................................................................................................14
End of Programmed Service .............................................................................................14
IPG Battery Life ................................................................................................................ 15

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Magnetic Resonance Imaging (MRI).
• The Precision Montage MRI Spinal Cord Stimulator (SCS) System is “MR Conditional”.
An MRI examination can be conducted safely using only a 1.5 Tesla horizontal closed-
bore whole-body MRI system for the MRI scan when all instructions in the supplemental
manual “ImageReady™ MRI Full Body Guidelines for Precision Montage MRI Spinal Cord
Stimulator System” are followed. The 1.5T MRI system can be congured to use the Full
Body, Head, and Extremity transmit/receive RF quadrature coils, and receive only coils of
any type. It is important to read the information in this supplemental manual in its entirety
before conducting or recommending an MRI examination on a patient with a Precision
Montage MRI SCS System. The “ImageReady™ MRI Full Body Guidelines for Precision
Montage MRI Spinal Cord Stimulator System” manual appears on the Boston Scientic
websites (www.bostonscientic.com/MRI and www.bostonscientic.com/ImageReady). MRI
examinations performed on patients with the Precision Montage MRI System using open-
sided MRI systems, or other types of MRI systems operating at other static magnetic eld
strengths (higher or lower) have not been assessed and, as such, should not be performed.
• External Devices: Boston Scientic external components (i.e., External Trial Stimulator
and OR Cable, Remote Control and accessories, Battery Charger) are MR Unsafe.
They must not be taken into any MR environment such as the MRI scanner.
Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been established
for pediatric use.
Diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be
used on SCS patients. The energy generated by diathermy can be transferred through the
Stimulator system, causing tissue damage at the lead site and resulting in severe injury or
death. The IPG, whether it is turned on or off, may be damaged.
Implanted Stimulation Devices. Spinal cord stimulators may interfere with the operation of
implanted sensing stimulators such as pacemakers or cardioverter debrillators. The effects of
implanted stimulation devices on neurostimulators is unknown.
Stimulator Damage. Burns may result if the pulse generator case is ruptured or pierced
and patient tissue is exposed to battery chemicals. Do not implant the device if the case is
damaged.
Postural Changes. Patients should be advised that changes in posture or abrupt movements
may cause decreases, or uncomfortable or painful increases in the perceived stimulation
level. Patients should be advised to turn down the amplitude or turn off the IPG before making
posture changes.
Important: If unpleasant sensations occur, the IPG should be turned off immediately.

Safety Information
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Electromagnetic Interference. Strong electromagnetic elds can potentially turn the
Stimulator off, cause temporary unpredictable changes in stimulation, or interfere with the
Remote Control communication. Patients should be counseled to avoid or exercise care around
the following:
• Theft detectors, tag deactivators and RFID devices, such as those used at department
stores, libraries, and other public establishments. The patient should proceed with
caution, ensuring to move through the center of the detector as quickly as possible.
• Security screeners, such as those used in Airport Security or at entrances to government
buildings, including hand-held scanners. The patient should request assistance to
bypass the device. If the patient must pass through the security screener, they should
move quickly through the device staying as far from the physical device as allowable.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other
anti-theft systems that can broadcast a radio frequency (RF) signal. The
high energy elds produced by these systems may interfere with the
operation of the Remote Control and its ability to control stimulation.
• Other sources of electromagnetic disturbance, such as RF transmitters
at television or radio broadcast stations, Amateur Radio or Citizens Band
radio transceivers, or Family Radio Service band transceivers.
Note: When in close proximity, equipment that generates strong electromagnetic
elds might cause unintended stimulation or interfere with wireless
communication even if they comply with International Special
Committee on Radio Interference (CISPR) requirements

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Precautions
Physician training is required.
Medical Devices/Therapies. The following medical therapies or procedures may turn
stimulation off or may cause permanent damage to the Stimulator, particularly if used in close
proximity to the device:
• lithotripsy
• electrocautery (See “Instructions for the Physician” on page 8)
• external debrillation
• radiation therapy (Any damage to the device by radiation may not be immediately
detectable.)
• ultrasonic scanning
• high-output ultrasound
X-ray and CT scans may damage the Stimulator if stimulation is on. X-Ray and CT Scans are
unlikely to damage the Stimulator if stimulation is turned off.
If any of the above is required by medical necessity, refer to “Instructions for the Physician” on
page 8. Ultimately, however, the device may require explantation as a result of damage to
the device.
Automobiles and Other Equipment. Patients should not operate automobiles, other
motorized vehicles, or potentially dangerous machinery/ equipment with therapeutic stimulation
switched on. Stimulation must be turned off rst. Sudden stimulation changes, if they occur,
may distract patients from attentive operation of the vehicle or equipment.
Post Operative. During the two weeks following surgery, it is important that patients use
extreme care so that appropriate healing will secure the implanted components and close the
surgical incisions:
• Patients should not lift objects of more than 2.5 kilograms (ve pounds).
• Patients should not engage in rigorous physical activity such as twisting, bending, or
climbing.
• If new leads were implanted, patients should not raise their arms above their head.
Temporarily, there may be some pain in the area of the implant as the incisions heal. Patients
should be instructed that if discomfort continues beyond two weeks, they should contact their
physician.
If patients notice excessive redness around the wound areas during this time, they should
contact their physician to check for infection and administer proper treatment. In rare cases,
adverse tissue reaction to implanted materials can occur during this period.
Patients should consult their physician before making lifestyle changes due to decreases in
pain.

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Stimulator Location. Patients should never attempt to change the orientation or “ip” (rotate
or spin) the Stimulator. Patients should not “nger” or play with the Stimulator. If the Stimulator
ips over in the Patient’s body, it cannot be charged. If the Patient knows that the device has
turned, or if stimulation cannot be turned on after charging, the Patient should contact his or her
physician to arrange an evaluation of the system. In some cases, the skin over the Stimulator
may become very thin over time. If this occurs, Patients should contact their physicians.
Lead Location. In some instances a lead can move from its original location, and stimulation
at the intended pain site can be lost. If this occurs, Patients should consult their physician who
may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning
the lead during another operation.
Device Failure. Stimulators can fail at any time due to random component failure, loss of
battery functionality, or lead breakage. If the device stops working even after complete charging
(up to four hours), Patients should turn off the Stimulator and contact their physician so that the
system can be evaluated.
Operating Temperature. The operating temperature of the Trial Stimulator, Remote Control,
and Programming Wand is 5–40 °C (41–104 °F). For proper operation, do not use the Charger
if the ambient temperature is above 35 °C (95 °F).
Storage, Handling and Transport. Do not expose the Remote Control or Charging System
components to excessively hot or cold conditions. Do not leave the devices in your car
or outdoors for extended periods of time. The sensitive electronics can be damaged by
temperature extremes, particularly high heat.
If the Remote Control or the Charging System is to be stored for a period of time without
batteries, the storage temperature should not exceed -20 to 60 °C (-4 to 140 °F).
Handle the system external components and accessories with care. Do not drop them or
submerge them in water. Although reliability testing has been performed to ensure quality
manufacturing and performance, dropping the devices on hard surfaces or in water, or other
rough handling, can permanently damage these components. (See “Limited Warranty - IPG”.)
Upon completion of the Patient Trial, remove the batteries from the Trial Stimulator.
Component Disposal. Do not dispose of the Remote Control or Charger in re. The battery
in these devices can explode in re. Dispose of used batteries in accordance with local
regulations. The IPG should be explanted in the case of cremation, and returned to Boston
Scientic. External devices to be disposed of per local regulatory requirements. Please contact
your healthcare professional.

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Remote Control, Charging System, External Trial Stimulator and Wand Cleaning. The
charging system components can be cleaned using alcohol or a mild detergent applied with a
cloth or tissue. The Remote Control, External Trial Stimulator and Programming Wand can be
cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from
soapy detergents should be removed with a cloth lightly dampened with water. Do not use
abrasive cleansers for cleaning. Do not clean any of the accessories while they are directly or
indirectly connected to a power outlet.
Cell Phones. While we do not anticipate any interference with cell phones, the full effects
of interaction with cell phones are unknown at this time. If there is a concern or a problem is
encountered, the patients should contact their physician.
Adverse Effects
Potential risks are involved with any surgery.
The possible risks of implanting a pulse generator as part of a system to deliver spinal cord
stimulation include:
• Lead migration, resulting in undesirable changes in stimulation and subsequent reduction in
pain relief.
• System failure, which can occur at any time due to random failure(s) of the components
or the battery. These events, which may include device failure, lead breakage, hardware
malfunctions, loose connections, electrical shorts or open circuits and lead insulation
breaches, can result in ineffective pain control.
• Tissue reaction to implanted materials can occur. In some cases, the formation of reactive
tissue around the lead in the epidural space can result in delayed onset of spinal cord
compression and neurological/sensory decit, including paralysis. Time to onset is variable,
possibly ranging from weeks to years after implant.
• Skin erosion at the IPG site can occur over time.
• Possible surgical procedural risks are: temporary pain at the implant site, infection,
cerebrospinal uid (CSF) leakage and, although rare, epidural hemorrhage, seroma,
hematoma and paralysis.
• External sources of electromagnetic interference may cause the device to malfunction and
affect stimulation.
• Exposure to MRI can result in heating of tissue, image artifacts, induced voltages in the
neurostimulator and/or leads, lead dislodgement.
• Undesirable stimulation may occur over time due to cellular changes in tissue around the
electrodes, changes in electrode position, loose electrical connections and/or lead failure.

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• The patient may experience painful electrical stimulation of the chest wall as a result of
stimulation of certain nerve roots several weeks after surgery.
• Over time, the Stimulator may move from its original position.
• Weakness, clumsiness, numbness or pain below the level of implantation.
• Persistent pain at the IPG or lead site.
In any event, instruct the patient to contact their physician to inform him/her.

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Instructions for the Physician
Implanted Stimulation Devices. If such implanted devices are indicated for the patient,
careful screening is required to determine if safe results can be achieved before permanently
implementing concurrent electrical therapies.
Postural Changes. Depending on the activity level of the patient, postural changes may affect
stimulation intensity. Instruct patients to keep the Remote Control on hand at all times, and
ensure that they understand how to adjust stimulation levels. Refer to Postural Changes in the
Instructions for Patients section of this manual, page 2, for additional information.
Medical Devices/Therapies. If the patient is required to undergo lithotripsy, electrocautery,
external debrillation, radiation therapy, ultrasonic scanning, or high-output ultrasound, X-ray or
CT scan:
• Turn off stimulation at least ve minutes before the procedure or application.
• All equipment, including ground plates and paddles, must be used as far away from the IPG
as possible.
• Every effort should be taken to keep elds, including current, radiation, or high-output
ultrasonic beams, away from the IPG.
• Equipment should be set to the lowest energy setting clinically indicated.
• Instruct patients to conrm IPG functionality following treatment by turning on the IPG and
gradually increasing stimulation to the desired level.
Essential Performance
Failure of the external electrical components will not result in an unacceptable risk to the user.
Telemetry Information
Frequency Band: 119 – 131 kHz
Modulation type: FSK
Effective Radiated Power: 0.05 mW (-13 dBm) maximum
Magnetic Field Strength (at 3 m distance): 46 μA/m

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Sterilization
All Precision Montage MRI System implantable and surgical components are sterilized with
ethylene oxide.
Inspect the condition of the sterile package before opening the package and using the contents.
Do not use the contents if the package is broken or torn, or if contamination is suspected
because of a defective sterile package seal.
• Do not use any component that shows signs of damage.
• Do not resterilize the package or the contents. Obtain a sterile package from Boston
Scientic.
• Do not use if the product is past the labeled expiration date.
• All components are for single use only. Do not reuse.
• Do not use if package is opened or damaged.
• Do not use if labeling is incomplete or illegible.
WARNING: Contents supplied STERILE using an ethylene oxide (EO) process. Do not use
if sterile barrier is damaged. If damage is found, call your Boston Scientic representative.
For Single Use Only.
Do Not Reuse.
Do Not Resterilize.
Do not use if package is damaged.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or
resterilization may also create a risk of contamination of the device and/or cause patient
infection or crossinfection, including, but not limited to, the transmission of infectious disease(s)
from one patient to another. Contamination of the device may lead to injury, illness or death of
the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or
local government policy.

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Electromagnetic Compatibility
EN 60601-1-2 Classication Information
• Internally Powered Equipment
• Continuous Operation
• Ordinary Equipment
• Class II
Guidance and Manufacturer’s Declaration - electromagnetic emissions
The Precision Montage MRI System intended for use in the electromagnetic environment specied
below. The customer or user of the IPG should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment Guide
RF emissions CISPR 11 Group 1 The Precision Montage MRI System uses
RF energy only for its internal function.
Therefore, its RF emissions are very low
and are not likely to cause any interference
in nearby electronic equipment.
RF emissions CISPR 11 Class B The Precision Montage MRI System is
suitable for use in all establishments.
Including domestic establishments and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class B
Voltage uctuations
/ Flicker emissions
IEC 61000-3-3
Complies

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Guidance and manufacturer’s declaration – electromagnetic immunity
The Precision Montage MRI System is intended for use in the electromagnetic environment specied
below. The customer or the user of the Precision Montage MRI System should assure that it is used in
such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
environment
– guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
Air:
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact:
± 8 kV
Air:
Remote Control
and Charger:
± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
ETS and Wand:
± 2 kV, ± 4 kV, ± 8 kV
Contact:
Remote Control and
Charger: ± 8 kV
ETS and Wand:
± 6 kV
Floors should be
wood, concrete
or ceramic tile. If
oors are covered
with synthetic
material, the relative
humidity should
be at least 30 %.
Note: Applies to
external devices.
Electrical fast transient/
burst IEC 61000-4-4
(Programming
Wand only)
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge IEC 61000-4-5
(Programming
Wand only)
± 1 kV line(s)
to line(s)
± 2 kV line(s) to earth
± 1 kV line(s)
to line(s)
± 2 kV line(s) to earth
Mains power quality
should be that of a
typical commercial or
hospital environment.

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Guidance and manufacturer’s declaration – electromagnetic immunity
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
(Programming
Wand only)
<5 % U
T
(>95 % dip in U T )
for 0,5 cycle
40 % U T
(60 % dip in U T )
for 5 cycles
70 % U T
(30 % dip in U T )
for 25 cycles
<5 % U T
(>95 % dip in U T )
for 5 s
<5 % U T
(>95 % dip in U T )
for 0,5 cycle
40 % U T
(60 % dip in U T )
for 5 cycles
70 % U T
(30 % dip in U T )
for 25 cycles
<5 % U T
(>95 % dip in U T )
for 5 s
Mains power quality
should be that of a
typical commercial or
hospital environment.
If the user of the
Precision Montage
MRI System requires
continued operation
during power mains
interruptions, it
is recommended
that the Precision
Montage MRI
System be
powered from an
uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m 30 A/m Power frequency
magnetic elds
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Magnetic elds from
common appliances
are not expected to
affect the device.
NOTE U
T is the a.c. mains voltage prior to application of the test level.

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Guidance and manufacturer’s declaration – electromagnetic immunity
The Precision Montage MRI System is intended for use in the electromagnetic environment specied
below. The customer or the user of the Precision Montage MRI System should assure that it is used in
such an environment.
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - guidance
Conducted RF
IEC 61000-4-6
(ETS only)
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
6 Vrms in ISM
and amateur
radio bands
between
150 kHz and
80 MHz
Professional healthcare facility environment
and home healthcare environment.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2,7 GHz
10 V/m
80 MHz to
2,7 GHz
Professional healthcare facility environment
and home healthcare environment.
Field strengths from xed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency range. Interference
may occur in the vicinity of equipment
marked with the symbol shown below:
NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF
transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the
location in which the Precision Montage MRI System is used exceeds the applicable RF compliance
level above, the Precision Montage MRI System should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the Precision Montage MRI System.

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Recommended separation distances between portable and mobile RF
communications equipment and the Precision Montage MRI System
The Precision Montage MRI System is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Precision Montage MRI
System can help prevent electromagnetic interference by maintaining a minimum distance of 30 cm
between portable and mobile RF communications equipment (transmitters) and the Precision Montage
MRI System.
NOTE These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reection from structures, objects and people.
Notice to the User Per Industry Canada Radio Standards Specications:
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions:
1. this device may not cause interference, and
2. this device must accept any interference, including interference that may cause undesired
operation of the device.
Technical Service
There are no user serviceable parts. If you have a specic question or issue, please contact
your Boston Scientic representative.
End of Programmed Service
The Precision Montage MRI System IPG software is programmed to end service after 12
years. As the IPG nears the end of the programmed period, the Remote Control and Clinician
Programmer provide the following indicators to inform the user that the end of the programmed
period is approaching:
• Remote Control - Approximately six months before the end of programmed
period, the Remote Control displays a weekly message indicating the
number of service days remaining. Approximately one month before
the end of the programmed period, the message displays daily.

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• Clinician Programmer - When less than six months of service remain, an indicator displays
on the Connect screen of the Clinician Programmer. When end of the programmed period
has been reached, a message displays when connecting to the Stimulator to indicate
that end of the programmed period has been reached and programming is not allowed.
Patients should contact their health care provider upon rst receiving a message regarding the
number of service days remaining.
IPG Battery Life
The rechargeable battery in the Precision Montage MRI System IPG should provide at least
ve years and up to 25 years or more of service.1 The IPG recharge interval at typical settings
is at least 30 days.2 Over time, the IPG battery will need more frequent recharges. Like all
rechargeable batteries, use over time and repeated recharge cycles reduce the maximum
charge capacity of the IPG battery. Battery life is dependent on your stimulation settings and
conditions.
1 The expected years of battery operation are dened as the longer of either:
A. Typical case: the time at which therapy cannot be maintained with daily charging.
OR
B. High energy case: when the maximum recharge interval has decreased by more than 50 % from the initial recharge
interval.
2 This estimated recharge interval is based on the following assumptions:
• The Precision Montage MRI PG is newly implanted and at the beginning of its charging life.
• The IPG has been programmed to the following settings: Current amplitude: 4 mA; Pulse Width: 300 μs; Pulse Rate:
50 Hz and Impedance: 750 Ohms.
NOTE: Your actual settings may vary, thus varying the number of days for your recharge interval.