Boston Scientific Precision Montage SC-1200 Manual

91053242-08 REV A
en tres rufr arde elit cznl sksv plhuno da pt ptBR
Directions for Use
Instrucciones de uso
Mode d’emploi
Gebrauchsanweisung
Istruzioni per l’uso
Gebruiksaanwijzing
Bruksanvisning
Käyttöohje
Bruksanvisning
Brugsanvisning
Instruções de Utilização
Instruções de uso
Kullanım Talimatları
Указания по использованию
 
Οδηγίες χρήσης
Návod k použití
Návod na použitie
Instrukcja obsługi
Használati utasítások
CAUTION: Federal law restricts this device
to sale, distribution and use by or on the order
of a physician.
Precision Montage™ MRI
16 Contact Implantable
PulseGenerator
Directions for Use
Boston Scientific Confidential. Unauthorized use is prohibited.
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Implantable Pulse Generator
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Implantable Pulse Generator
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.
Drawings are for illustration purposes only.
Trademarks
All trademarks are the property of their respective holders.

IC: 9773A-SC1132
Additional Information
For Indications and related information, see the Indications DFU for your spinal cord stimulator system.
For contraindications, warnings, precautions, adverse events summary, physician instructions, sterilization,
component disposal, and contact information for Boston Scientic, refer to the Information for Prescribers
DFU for your spinal cord stimulator system. For other device-specic information not included in this
manual, labeling symbols, and warranty, refer to the appropriate DFU as listed on your Reference Guide.
For SCS Implant conditions for MRI eligibility, refer to the appropriate MRI guidelines manual for your SCS
system as listed on your Reference Guide.
For information regarding the Patient Identication Card, FCC rules and for clinical studies
supporting the clinical use of the neurostimulation system, refer to the Information for Prescribers manual.
Product Model Number
Model Description
SC-1200 Precision Montage™ MRI 16 Contact Implantable Pulse Generator
Boston Scientific Confidential. Unauthorized use is prohibited.
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
..................................................................................................................1
Compatible Leads....................................................................................................1
SCS Systems with ImageReady™ MRI Technology ...............................................1
Compatible Leads for Full Body MRI Eligibility .......................................................1
 ......................................................................................................1
IPG Kit .....................................................................................................................1
.............................................2
...........................................2
............................................................................3
......................................................................................................................3
 ..................................................................................4
............................................................................................4
....................................................................................................5
SCS Implant Conditions for Full Body MRI Eligibility...............................................5
IPG Handling and Storage.......................................................................................5
Pre-Op Instructions..................................................................................................6
IPG Implantation......................................................................................................6
Tunneling the Lead or Lead Extension ....................................................................7
Connecting the Lead, Extension, Splitter, or Connector to the IPG.........................9
Connecting to the IPG: ............................................................................................9
IPG Explant or Replacement .................................................................................10
 ........................................................................... 11
......................................................................................................... 11
....................................................................................................12
Boston Scientific Confidential. Unauthorized use is prohibited.
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Description
Implantable Pulse Generator
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Description
The Precision Montage™ MRI Implantable Pulse Generator (IPG) system is intended to treat chronic pain
by electrically stimulating the spinal cord. The multi-channel, multi-electrode device capability provides
exibility in conjunction with ease of programming. A rechargeable battery increases IPG longevity
and output capability while reducing size and device replacement surgeries. The IPG is controlled by a
handheld Remote Control, and can be engaged by a clinician programmer using proprietary programming
software. Periodically, the IPG battery requires replenishing with an external RF charging device.
Compatible Leads
• Innion™ 16 xxcm 16 Contact Lead
• Innion™ CX xxcm 16 Contact Lead
• Linear™ xxcm 8 Contact Lead
• Linear ST xxcm 8 Contact Lead
• Linear 3-4 xxcm 8 Contact Lead
• Linear 3-6 xxcm 8 Contact Lead
• Artisan™ 2x8 Surgical Lead
• Avista™ MRI xxcm 8 Contact Lead
• 8 Contact Extensions
• 2x4 Splitters
• 2x8 Splitters
Note: xx denotes length (cm). The Precision Montage MRI System supports any combination of 8 contact
percutaneous, 16 contact percutaneous and 16 contact surgical leads totaling up to 16 active
contacts.
SCS Systems with ImageReady™ MRI Technology
When an appropriate Boston Scientic SCS System with ImageReady MRI Technology is implanted as
directed (see “SCS Implant Conditions For Full-body MRI Eligibility” in this manual), a patient’s full body
may be eligible for MRI scans under specic conditions. For detailed information about eligibility and
conditions for MRI scanning, refer to the ImageReady MRI Full Body Guidelines for the Precision Montage
MRI System.
Compatible Leads for Full Body MRI Eligibility
• Avista™ MRI xxcm 8 Contact Lead
Package Contents
IPG Kit
(1) Implantable Pulse Generator
(1) Hex Wrench
(1) IPG Pocket Template
(2) Port Plugs
(1) Device Registration Form and Temporary Patient Identication Card
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Implantable Pulse Generator
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Max Current Amplitude per Electrode Vs Impedance
0.00
5.10
10.20
15.30
20.40
25.50
300 400 500 600 700 800 900 1000 1100 1200
Current (mA)
Impedance (Ω)
Maximum Amplitude Based on Impedance and Pulse Width
PW = 20 us
PW = 100 us
PW = 200 us
PW = 300 us
PW = 400 us
PW = 600 us
PW = 800 us
PW = 1000 us
Programmable up to 25.5 mA
Programmable up to 21.1 mA
Programmable up to 15.8 mA
Programmable up to 12.7 mA
20 µsec
100 µsec
200 µsec
300 µsec
400 µsec
600 µsec
800 µsec
1000 µsec
Pulse Width:
Max Amplitude Based on Frequency and Pulse Width
0.00
5.10
10.20
15.30
20.40
25.50
0200 400 600 800 1000 1200
Current (mA)
Frequency (Hz)
Maximum Amplitude Based on Frequency and Pulse Width
PW = 20 us
PW = 100 us
PW = 200 us
PW = 300 us
PW = 400 us
PW = 600 us
PW = 800 us
PW = 1000 us
Pulse Width:
20 µsec
100 µsec
200 µsec
300 µsec
400 µsec
600 µsec
800 µsec
1000 µsec
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
Implantable Pulse Generator
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Specications and Technical Data
Parameter  
Areas (Channels) 4 —
Amplitude 0 – 25.5 mA 0 mA
Rate 2 – 1200 ppsa40 pps
Width 20 – 1000 μsecb210 μsec
Cycle 1 sec – 90 min, OFF OFF
Ramp ON 1 – 10 secs 3 secs
Contacts 1 – 16, case: +100% to -100%, OFF 1 – 16, case: OFF
a. Only one Area is available if the rate is >130 pps.
b. Amplitude × Width ≤ 12.7 µC
Materials
Case Titanium
Header Epoxy
Strain Relief Silicone
Size/Volume 51.3 mm x 46.0 mm x 10.8 mm / 19.8 cm3(including header)
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Implantable Pulse Generator
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Radiopaque Identication Tag
The IPG contains a radiopaque identication tag
The identication tag is visible using standard x-ray procedures.
Registration Information
In accordance with international practice and regulatory legislation in some countries, a registration form
is packed with each Boston Scientic neurostimulator. The purpose of this form is to maintain traceability
of all products and to secure warranty rights. It also allows the institution involved in the evaluation or
replacement of a specic device to gain quick access to pertinent data from the manufacturer.
Fill out the registration form included in the package contents. Return one copy to Boston Scientic,
keep one copy for patient records, provide one copy to the patient, and one copy to the physician.
Boston Scientic Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, California 91355, USA
Attention: Customer Service Department
Boston Scientific Confidential. Unauthorized use is prohibited.
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Instructions for Use
Implantable Pulse Generator
91053242-08 Rev A 5 of 279
Instructions for Use
SCS Implant Conditions for Full Body MRI Eligibility
CAUTION: To allow a patient full-body MRI scan eligibility under specic conditions, implant a Boston
Scientic SCS System with ImageReady MRI Technology described below. If the implant criteria
are not met, the patient will not have an SCS system with full-body MRI scan eligibility. MRI scans
performed under different conditions can result in patient injury or damage to the implantable device.
• Use only ImageReady MRI SCS system components (e.g., leads and IPGs) as specied in the
ImageReady™ MRI Full Body Guidelines for Precision Montage MRI SCS System.
Note: Lead extensions, adapters, and splitters are not full-body MRI scan eligible.
• Implant the IPG in the upper buttocks or lower ank.
• Implant the lead in the epidural space.
Note: Retrograde lead placements have not been evaluated for MRI.
• Use only the suture sleeves provided with the Avista™ MRI lead kit or the Clik™ X MRI anchor to
secure the Avista MRI leads.
• Explant any previously abandoned leads, extensions, splitters or adapters that may be in the
patient (i.e. leads, extensions, splitters, or adapaters, or portions of, that are not connected directly
to an IPG).
Note: Other implanted medical devices may limit or restrict MRI scans.
• It is recommended that you enter all component model number and implant location information
using the ImageReady MRI Full Body Patient Eligibility Checklist and maintain it in the patient’s
medical records. When adding, changing, or removing IPGs, leads or accessories, it is
recommended that you complete a new ImageReady MRI Full Body Patient Eligibility Checklist and
maintain it in the patient medical record.
• For the full body MRI conditions and MRI-specic warnings and precautions for conducting an MRI
scan, refer to the ImageReady MRI Full Body Guidelines for Precision Montage MRI SCS System.
IPG Handling and Storage
• Handle the IPG and all components with care.
• Keep sharp instruments away from the components.
• Do not use the IPG if it has been dropped.
• Do not incinerate an IPG. Improper disposal of the device could result in an explosion. Devices
should be explanted in the case of cremation, and returned to Boston Scientic Neuromodulation
Corporation. An explant kit is available.
• Store the IPG between 0 °C and 45 °C ( 32 °F and 113 °F). Devices should always be kept in
temperature regulated areas within the acceptable temperature range. IPG damage can occur at
temperatures outside of this range.
Boston Scientific Confidential. Unauthorized use is prohibited.
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Pre-Op Instructions
1. Ensure that the IPG is fully charged prior to the permanent implant procedure. The approximate
location of the IPG is marked on the IPG kit. Turn on the Charger and place it over the IPG to begin
charging. Refer to “Charging Steps” on page 11 for additional instructions.
2. Check that the sterile package is intact. (See “Sterilization” in the Information for Prescribers manual
for the Precision Montage MRI SCS System.)
3. If intra-operative stimulation testing is desired, ensure that a Trial Stimulator is available for use. Refer
to the Clinician Trial Manual for your SCS System for additional instructions.
IPG Implantation
1. Ensure that the area surrounding the lead entry site is incised to a dimension that will accommodate
the tunneling tool.
2. Check that the lead is securely anchored.
CAUTION: Do not use polypropylene sutures as they may damage the suture sleeve. Do not suture
directly onto the lead, or use a hemostat on the lead body. This may damage the lead insulation. In
addition, during an MRI scan, the patient could be at risk of tissue heating, resulting in tissue damage
or serious patient injury.
3. Select and mark the intended IPG site, using the IPG template, and create an incision for the IPG
pocket.
4. Create a subcutaneous pocket no larger than the IPG outline at a depth of up to 2.0 cm from the
surface. Implant charging could become ineffective at depths shallower than 0.5 cm or greater than
2.0 cm.
Note: For full-body MRI scan eligibility, conrm that the subcutaneous pocket for the IPG has been
created in the upper buttock or lower ank. (See the caution in “SCS Implant Conditions for Full
Body MRI Eligibility” in this manual).
5. Tunnel the lead(s) to the IPG site.
Note: Using the IPG template will help guide the correct pocket sizing. It is important to keep the pocket
small to reduce the chances of patient manipulation and IPG ipping. Select an IPG site several
inches away from the previously externalized trial lead site to reduce risk of infection.
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