Boston Scientific Neuromodulation SC1132 SC-1132 User Manual 90655621 03 IPG FALCON indb

Boston Scientific Neuromodulation Corporation SC-1132 90655621 03 IPG FALCON indb

Additional User Manual 3

CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
90655621-03 REV A
Precision Spectra™ System
Implantable Pulse Generator
Directions for Use
SC-1132 Implantable Pulse Generator
Implantable Pulse Generator
Implantable Pulse Generator
90655621-03 Rev A ii of iv
Copyright
© 2011 Boston Scientifi c Corporation or its affi liates. All Rights Reserved. These documents
are the property of Boston Scientifi c Corporation and shall not be reproduced, distributed,
disclosed, or used for manufacture or sale of device without the express written consent of
Boston Scientifi c Corporation.
Guarantees
Boston Scientifi 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
Precision Spectra and Infi nion are trademarks of Boston Scientifi c. Other brands and their
products are trademarks or registered trademarks of their respective holders and should be
noted as such.
Table of Contents
Implantable Pulse Generator
90655621-03 Rev A iii of iv
Product Model Number
SC-1132 Implantable Pulse Generator
Refer to the Indications for Use for indications and related information.
Refer to the appropriate Information for Prescribers manual for contraindications, warnings,
precautions, adverse events summary, Physician instructions, sterilization, component disposal,
and contact information for Boston Scientifi c. Refer to the Labeling Symbols Addendum for an
explanation of labeling symbols.
Refer to the following Directions for Use (DFU) for device specifi c instructions not included
in this manual: Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra™ System
Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming
Manual, and Programming Wand DFU.
Refer to the Limited Warranty for warranty information.
For information regarding the Patient Identifi cation Card, FCC rules and for clinical
studies supporting the clinical use of the neurostimulation system, refer to the Information for
Prescribers manual.
Table of Contents
Description ......................................................................................................................1
Package Contents .......................................................................................................... 1
IPG Kit .........................................................................................................................1
Specifi cations and Technical Data ................................................................................ 3
Registration Information ................................................................................................3
Instructions for Use ........................................................................................................ 4
IPG Handling and Storage ..........................................................................................4
Pre-Op Instructions .....................................................................................................4
IPG Implantation .........................................................................................................4
Tunneling the Lead or Lead Extension .......................................................................5
IPG Explant or Replacement.......................................................................................9
Rechargeable Stimulator System ................................................................................. 9
Charging Steps .............................................................................................................10
WARNINGS: .............................................................................................................10
IPG Battery Status ........................................................................................................ 11
Implantable Pulse Generator
Implantable Pulse Generator
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Description
Implantable Pulse Generator
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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 fl 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.
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 Identifi cation Card
Implantable Pulse Generator
Implantable Pulse Generator
90655621-03 Rev A 2 of 11
Maximum Current Amplitude per Electrode Versus Impedance
Pulse Width:
Current (mA)
Impedance (Ω)
Note: Maximum output capacity is frequency independent
Programmable up to 25.5 mA
Programmable up to 21.1 mA
Programmable up to 15.8 mA
Programmable up to 12.7 mA
Specifi cations and Technical Data
Implantable Pulse Generator
90655621-03 Rev A 3 of 11
Specifi 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 secb210 sec
Cycle 0.1 – 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 C.
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)
Radiopaque Identifi cation Tag
The IPG contains a radiopaque identifi cation tag “BSC IPG”. The identifi 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 Scientifi 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 specifi 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
Scientifi c, keep one copy for patient records, provide one copy to the patient, and one copy to
the physician.
Boston Scientifi c Neuromodulation
25155 Rye Canyon Loop
Valencia, California 91355
Attention: Customer Service Department
Implantable Pulse Generator
Implantable Pulse Generator
90655621-03 Rev A 4 of 11
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 Scientifi c
Neuromodulation. 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.
Instructions for Use
Implantable Pulse Generator
90655621-03 Rev A 5 of 11
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 fl ipping. Select
an IPG site several inches away from the previously externalized trial lead site to reduce
risk of infection.
Tunneling the Lead or Lead Extension
1. If not already assembled, attach the tunneling tool handle to the shaft by turning the locking
mechanism clockwise.
Tool Handle
Locking Mechanism
Shaft
2. Mark the desired route of the tunnel.
3. Administer the appropriate local anesthetic along the tunneling path.
4. OPTIONAL. If necessary, bend the tool shaft to conform to the patient’s body.
Implantable Pulse Generator
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5. Make a small incision at the desired exit site.
6. Create a subcutaneous tunnel between the lead(s) incision and the IPG pocket site until the
straw is visible and accessible at the exit point.
7. Unscrew and remove the tunneling tool handle.
8. Grasp the tip of the tool with one hand while holding the straw in place with the other hand.
Pull the tunneling tool shaft out through the straw.
9. Push the lead or extension through the straw, then withdraw the straw.
10. Pull the proximal end(s) out of the exit point.
11. Wipe the proximal end(s) clean.
Instructions for Use
Implantable Pulse Generator
90655621-03 Rev A 7 of 11
CAUTION: Do not tunnel splitter.
Note: If using the 2x8 Splitter and performing a permanent trial, the splitter tails may be
tunneled to the exit site.
Note: The following Codman Disposable Catheter Passers may be used in place of the
Boston Scientifi c tunneling tool:
REF 82-1515 (36 cm); REF 82-1516 (55 cm); REF 82-1517 (65 cm)
Note: When using a Codman Disposable Catheter Passer, tunnel from the midline incision to
the IPG pocket using the standard technique.
Connecting the Lead, Extension, Splitter, or Connector to the IPG
IPG ports are labeled as follows:
For convenience, connect leads or splitter tails to the IPG ports corresponding to their locations,
superior versus inferior or left versus right lead placements. For example:
• Superior leads to upper IPG ports A or B. Inferior leads to IPG ports C or D.
• For the Infi nion™16, connect the splitter tail with laser etched bands (contacts 1-8 of the
Infi nion 16 lead) to the left ports A or C and the unmarked splitter tail (contacts 9-16 of
the Infi nion 16 lead) to the right ports B or D.
• For the Artisan 2x8 surgical lead, connect the left side to the left ports A or C. Connect
the right side (the laser-etched tail), contacts 9-16, to the right ports B or D.
Implantable Pulse Generator
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90655621-03 Rev A 8 of 11
1. Fully insert the lead(s), extension(s), splitter(s), and/or connector(s) into the IPG port(s),
being careful not to stress or bend the proximal end of the lead. When the lead is properly
inserted, the lead will stop and the retention ring will be located under the set screw.
2. Fully insert a port plug into unused IPG ports.
Note: If you experience diffi culty when inserting the lead, lead extension, splitter, connector, or
port plug, use the hex wrench to loosen (counterclockwise) the set screw and/or gently
rotate the lead to help advance the proximal end.
Note: To confi rm good connections, check impedances before tightening the set screw. The
IPG must be in contact with the subcutaneous pocket in order to receive accurate
impedance measurements.
3. Pass the hex wrench through the hole in the septum located on the front or back of the IPG
header and tighten each set screw until the hex wrench “clicks,” indicating lock.
CAUTION: Ensure that the lead is fully inserted before tightening the set screw to prevent
lead damage
Note: If a port plug is used, it is still necessary to tighten the set screw on the port plug as
described above.
Note: The hex wrench is torque-limited and cannot be over-tightened.
4. Place the IPG in the subcutaneous pocket with logo marking facing up towards the skin.
5. Coil excess lead, extension, splitter, or connector under the IPG.
Rechargeable Stimulator System
Implantable Pulse Generator
90655621-03 Rev A 9 of 11
6. If desired, secure the IPG in the pocket by suturing through the holes in the IPG header.
CAUTION: Do not suture through leads or splitter.
7. Close and dress the wound(s).
IPG Explant or Replacement
1. Turn off the IPG.
2. Surgically open the IPG pocket and withdraw the device. Please try to preserve the integrity
of all components so that complete device assessment can be performed.
3. Loosen the connector set screws to release and remove the leads, extensions, or splitters.
4. For replacement, connect the new IPG following the instructions for “Connecting the Lead,
Extension, Splitter, or Connector to the IPG” on page 7. Or, to terminate therapy, surgically
remove the implanted lead system.
5. Notify Boston Scientifi c to document the reason for explant or replacement and to arrange
for return of IPG and components.
Rechargeable Stimulator System
The Precision Spectra™ Stimulator is rechargeable. Boston Scientifi c recommends any
recharge routine that fi ts the patient’s schedule and lifestyle while maintaining suffi cient charge
to maintain stimulation.
Developing a patient’s recharge routine involves fi nding the right balance among the following:
• How much power is required for the patient to experience effective therapy.
• How often the patient wants to recharge.
• How long the patient wants to recharge.
• How the patient would like to manage their personal schedule.
The Precision Spectra Clinician Programmer will estimate charging time based on 24 hours per
day of stimulation at the programmed settings. To charge fully, wait until the Charger emits an
end of charge beep signal or the Remote Control display indicates that the battery is charged.
Refer to the Patient’s Charger Handbook and the Physician’s Remote Control Directions for
Use for additional information. The recharging process is simple, but important.
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Charging Steps
WARNINGS:
• Patient should not charge while sleeping. This may result in a burn.
• While charging, the Charger may become warm. It should be handled with care.
• Failure to use the Charger with either the Charger Belt or an adhesive patch, as shown,
may result in a burn. If pain or discomfort is felt, cease charging and contact Boston
Scientifi c.
The Charger Base Station should be plugged in and the Charger placed in the Base Station
when not in use. When the indicator light is green, the Charger is fully charged. When the
indicator is amber, the Charger is partially charged, but is still able to deliver a charge to the
Stimulator.
1. When the indicator light is green, remove the Charger from the Base Station. The indicator
light will then turn off.
2. Press the power button. The indicator light will come on again, and the Charger will begin
beeping as it searches for the Stimulator.
3. Place the Charger over the Stimulator. When the Charger is aligned with the Stimulator, the
beeping will stop.
• Centering the Charger over the Stimulator will ensure the shortest charging time.
• Many patients are able to feel the implanted Stimulator and can place the Charger
directly on top of it.
• Alternatively, centering the Charger within the alignment area (i.e., the area where
the Charger does not beep) will also ensure that the Charger is aligned.
4. Secure the Charger over the Stimulator by using either an adhesive patch or the Charger
Belt.
• Adhesive Patch: Remove the clear liner from the patch. Apply the white side with
the blue stripe to the back of the Charger. Then remove the beige liner from the
patch. Secure the Charger over the Stimulator by pressing the adhesive to the skin
over the Stimulator.
• Charger Belt: Place the Charger into the pocket on the Charger Belt so that the
Power button is visible through the mesh fabric. Secure the Charger over the
Stimulator by adjusting the Charger Belt.
IPG Battery Status
Implantable Pulse Generator
90655621-03 Rev A 11 of 11
Note: If you accidentally locate the patch in the wrong place, or if the Charger Belt moves out
of alignment, the Charger will start beeping again. Use a new adhesive patch or readjust
the belt to place the Charger back into position.
5. When the Charger emits a series of double beeps, the Stimulator is fully charged. Turn off
the Charger, remove the Charger Belt or adhesive patch, and return the Charger to the
Base Station. Do not confuse the end of charge signal (a series of double beeps) with the
continuous beeps that indicate that the Charger is searching for the Stimulator.
Note: • The end of a charge signal is a distinct double beep, and the alignment indicator is a
steady continuous signal.
• The Remote Control will not be able to communicate with the IPG when charging.
Refer to “IPG Battery Life” in your Information for Prescribers manual for information on
Stimulator battery life.
IPG Battery Status
The patient Remote Control displays the Stimulator battery status when communicating with the
Stimulator. Refer to the Clinician’s Remote Control Directions for Use for additional information.
When the Remote Control indicates a low battery the Stimulator should be recharged as soon
as possible.
Failure to recharge may lead to loss of stimulation in less than 24 hours. After stimulation stops,
communication with the Stimulator will also cease. Until a suffi cient level of charge has been
attained, the Stimulator may not communicate with the Remote Control.
© 2012 Boston Scientifi c Corporation
or its affi liates. All rights reserved.
90655621-03 REV A 2012-04
Corporate Headquarters
Boston Scientifi c Neuromodulation
25155 Rye Canyon Loop
Valencia, CA 91355 USA
(866) 789-5899 in US and Canada
(661) 949-4000, (661) 949-4022 Fax
(866) 789-6364 TTY
www.bostonscientifi c.com
Email: neuro.info@bsci.com
AUS Australian Sponsor
Address
Boston Scientifi c (Australia) Pty Ltd
PO Box 332
BOTANY
NSW 1455
Australia
Free Phone 1800 676 133
Free Fax 1800 836 666
EU Authorised
Representative:
Boston Scientifi c International S.A.
55 Avenue des Champs Pierreux
TSA 51101
92729 NANTERRE CEDEX,
FRANCE
T: +33 1 57 66 80 00
F: +33 1 57 66 84 99
Authorized to affi x in 2012.

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