Boston Scientific precision spectra Manual

CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician. 90970875-06 REV A
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Directions for Use
Instrucciones de uso
Mode d’emploi
Gebrauchsanweisung
Istruzioni per l’uso
Gebruiksaanwijzing
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Käyttöohje
Bruksanvisning
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Instruções de Utilização
Instruções de uso
Kullanım Talimatları
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Precision Spectra™ System
Implantable Pulse Generator
Directions for Use
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070451 A.1
Spectra IPG Entrada 2.0 19L
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Implantable Pulse Generator
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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.
Drawings are for illustration purposes only.
Trademarks
All trademarks are the property of their respective holders.
Industry Canada Equipment Certication Number
IC: 9773A-SC1132
Additional Information
For Indications and related information, see the Indications DFU. 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 instructions not included in this manual, labeling symbols, and
warranty information, refer to the appropriate DFU 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
for your SCS system.
Product Model Number
Model Number Description
SC-1132 Implantable Pulse Generator
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070451 A.1
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Table of Contents
Description........................................................................................................................................................................ 1
Compatible Leads:....................................................................................................................................................... 1
Package Contents ............................................................................................................................................................ 1
IPG Kit.......................................................................................................................................................................... 1
Max Current Amplitude per Electrode Vs Impedance................................................................................................... 2
(for all leads other than the 4x8 Surgical Lead) ........................................................................................................... 2
Max Current Amplitude per Electrode Vs Impedance................................................................................................... 2
(for the 4x8 Surgical Lead)........................................................................................................................................... 2
Max Amplitude Based on Frequency and Pulse Width ................................................................................................ 3
(for all leads other than the 4x8 Surgical Lead) ........................................................................................................... 3
Max Amplitude Based on Frequency and Pulse Width ................................................................................................ 3
(for the 4x8 Surgical Lead)........................................................................................................................................... 3
Specications and Technical Data.................................................................................................................................. 4
Materials............................................................................................................................................................................ 4
Radiopaque Identication Tag ........................................................................................................................................ 5
Registration Information.................................................................................................................................................. 5
Instructions for Use.......................................................................................................................................................... 6
IPG Handling and Storage........................................................................................................................................... 6
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
IPG Explant or Replacement ......................................................................................................................................11
Rechargeable Stimulator System ..................................................................................................................................11
Charging Steps................................................................................................................................................................11
IPG Battery Status.......................................................................................................................................................... 12
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
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Description
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Description
The Precision Spectra™ 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 xx cm 16 contact lead
• Innion CX xxcm 16 Contact Lead
• Linear™ xx cm 8 Contact Leads
• Linear ST xx cm 8 Contact Leads
• Linear 3-4 xx cm 8 Contact Leads
• Linear 3-6 xx cm 8 Contact Leads
• Artisan™ 2x8 Surgical leads
• CoverEdge™ 32 xxcm 4x8 Surgical Lead
• CoverEdge X 32 xxcm 4x8 Surgical Lead
• 8 Contact Extensions
• 2x4 Splitters
• 2x8 Splitters
Note: xx denotes length (cm)
The Precision Spectra System supports any combination of 8 contact percutaneous, 16 contact
percutaneous and 16 contact surgical leads totaling up to 32 active contacts.
Package Contents
IPG Kit
(1) Precision Spectra Implantable Pulse Generator
(1) Hex Wrench
(1) Tunneling Tool Assembly
(1) IPG Pocket Template
(4) Port Plugs
(1) Device Registration Form and Temporary Patient Identication Card
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Max Current Amplitude per Electrode Vs Impedance
(for all leads other than the 4x8 Surgical Lead)
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 ()
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 Current Amplitude per Electrode Vs Impedance
(for the 4x8 Surgical Lead)
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 ()
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 to17.6 mA
Programmable up to 13.2 mA
Programmable up to 10.6 mA
Pulse Width:
20 µsec
100 µsec
200 µsec
300 µsec
400 µsec
600 µsec
800 µsec
1000 µsec
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070451 A.1
Spectra IPG Entrada 2.0 19L
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Max Amplitude Based on Frequency and Pulse Width
Implantable Pulse Generator
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Max Amplitude Based on Frequency and Pulse Width
(for all leads other than the 4x8 Surgical Lead)
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
Max Amplitude Based on Frequency and Pulse Width
(for the 4x8 Surgical Lead)
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
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070451 A.1
Spectra IPG Entrada 2.0 19L
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Implantable Pulse Generator
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Specications and Technical Data
Parameter Range Default
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 – 32, case: +100% to -100%, OFF 1 – 32, case: OFF
a. Only one Area is available if the rate is >130 pps.
b. Amplitude × Width ≤ 12.7 µC for all leads other than the 4x8 Surgical Lead; Amplitude × Width
≤ 10.6 μC for the 4x8 Surgical Lead.
Materials
Case Titanium
Header Epoxy
Strain Relief Silicone
Size/Volume 55.0 mm x 46.0 mm x 10.8 mm / 21.2 cm3(including header)
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070451 A.1
Spectra IPG Entrada 2.0 19L
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Radiopaque Identication Tag
Implantable Pulse Generator
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Radiopaque Identication Tag
The IPG contains a radiopaque identication tag “BSC IPG”. 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.
Production
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Instructions for Use
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 on a hard surface.
• 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.
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” in this manual for additional instructions.
2. Check that the sterile package is intact. (See “Sterilization” in the Information for Prescribers manual.)
3. If intra-operative stimulation testing is desired, ensure that a Trial Stimulator is available for use. Refer
to the Clinician Trial Manual 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.
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.
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.
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070451 A.1
Spectra IPG Entrada 2.0 19L
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