Boston Scientific Artisan Manual

CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
Surgical Leads
Directions for Use
92395574-02
Content: MP92395574-02 REV A
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Directions for Use
Mode d’emploi
Gebrauchsanweisung
Gebruiksaanwijzing
Instrucciones de uso
Istruzioni per l’uso
Instruções de Utilização
Οδηγίες χρήσης
Bruksanvisning
Brugsanvisning
Käyttöohje
Bruksanvisning
Návod k použití
Návod na použitie
Használati utasítások
Instrukcja obsługi
Указания за употреба
Upute za upotrebu
Instrucțiuni de utilizare
Navodila za uporabo

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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.
Additional Information
For Indications and related information, see the Indications DFU or Clinician Manual for your spinal cord
stimulator system. For contraindications, warnings, precautions, adverse events summary, physician
instructions, sterilization, component disposal, and Contacts information for Boston Scientic, refer to
the Information for Prescribers DFU or Clinician Manual 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 for your SCS system as listed on your Reference Guide.
Product Model Numbers
Model Description
SC-3138-xx xxcm 8 Contacts Lead Extension Kit
SC-8120-xx ArtisanTM xxcm 2x8 Surgical Lead Kit
SC-8216-xx Artisan xxcm 2x8 Surgical Lead Kit
SC-8416-xx Artisan MRI xxcm 2x8 Surgical Lead Kit
SC-8336-xx CoverEdgeTM 32 xxcm 4x8 Surgical Lead Kit
SC-8436-xx CoverEdge MRI 32 Surgical Paddle Lead
SC-8352-xx CoverEdge X 32 xxcm 4x8 Surgical Lead Kit
SC-8452-xx CoverEdge X MRI 32 Surgical Paddle Lead
Note: xx refers to length (cm).

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Table of Contents
Description...................................................................................................................................... 1
Surgical Paddle Lead.................................................................................................................. 1
2x8 Surgical Paddle Lead ........................................................................................................... 1
4x8 Surgical Paddle Lead ........................................................................................................... 1
Lead Extension ........................................................................................................................... 1
Package Contents .......................................................................................................................... 2
Lead Extension Kit ...................................................................................................................... 2
2x8 Surgical Paddle Lead Kit...................................................................................................... 2
4x8 Surgical Paddle Lead Kit...................................................................................................... 2
Specications and Technical Data................................................................................................ 3
2x8 Surgical Lead ....................................................................................................................... 3
4x8 Surgical Lead ....................................................................................................................... 3
Lead Extension ........................................................................................................................... 3
Registering the Leads.................................................................................................................... 4
Instructions for Use........................................................................................................................ 5
Lead and Lead Extension Handling and Storage........................................................................ 5
Paddle Lead Placement in the Epidural Space........................................................................... 5
Intraoperative Stimulation Testing ............................................................................................... 6
Anchoring the Lead..................................................................................................................... 6
Tunneling the Lead or Lead Extension ....................................................................................... 7
Connecting the Lead Extension .................................................................................................. 9

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Description
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Description
The surgical Paddle Leads function as a component of Boston Scientic’s Spinal Cord Stimulator (SCS)
systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord,
resulting in an inhibition of pain sensation.
Surgical Paddle Lead
2x8 Surgical Paddle Lead
The 2x8 Surgical Lead is available in lengths of 50 cm and 70 cm. The distal (paddle) end of the Lead has
two columns of eight evenly spaced planar electrodes. Each electrode is 3x2 mm in size. On the proximal
side, this Lead employs 2 Lead tails. The end of each tail has eight evenly spaced Contacts. The right tail
of the Paddle Lead is laser-etched to allow for ease of right and left identication. Each tail can be inserted
into an IPG, or into a Lead Extension.
4x8 Surgical Paddle Lead
The 4x8 CoverEdge™ Surgical Leads are available in lengths of 50 cm and 70 cm with tightly spaced
electrodes or widely spaced electrodes. The distal (paddle) end of the Lead has four columns of 8 evenly
spaced planar electrodes. Each electrode is 1x3.4 mm in size. On the proximal side, the Lead has 4 tails.
The end of each tail has 8 evenly spaced Contacts. Each tail of the Paddle Lead is uniquely identied
with marker bands. Reading from left to right with the electrodes faced down, the rst tail has one
marker band, the second has two, the third has three, and the fourth has four marker bands. Each tail
corresponds to the respective column of Contacts on the paddle. Each tail can be inserted into an IPG, or
into a Lead Extension.
Note: The 4x8 Surgical Lead is intended for use with the Boston Scientic 4-port SCS Stimulators.
Lead Extension
Lead Extensions are designed to connect the percutaneous and Paddle Leads to the IPG for spinal cord
stimulation. The Extension may be added to a Lead to externalize the Lead for a trial procedure or to
extend the Lead when a permanent IPG is implanted.
Lead Extensions are available in lengths of 25 cm, 35 cm, and 55 cm. The Lead Extensions can be
connected to either the Trial Stimulator (via an OR Cable Assembly) or directly to an IPG.

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Package Contents
Lead Extension Kit
(1) Lead Extension
(1) Hex Wrench
(1) Tunneling Tool Assembly
(1) Device Registration Form/Temporary Patient Identication Card
2x8 Surgical Paddle Lead Kit
(1) Paddle Lead
(4) Suture Sleeves
(2) Lead Position Labels—left and right (non-sterile)
(1) Device Registration Form/Temporary Patient Identication Card
4x8 Surgical Paddle Lead Kit
(1) Paddle Lead
(6) Suture Sleeves
(1) Device Registration Form/Temporary Patient Identication Card

Specications and Technical Data
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Specications and Technical Data
2x8 Surgical Lead
Part Specication
Lead Lengths 50, 70 cm
Lead Shape 2 x 8 paddle
Lead Width 8 mm
Number of Electrode Contacts 16
Electrode Length 3 mm
Electrode Spacing 1 mm
Contacts Material Platinum
Insulation Material Silicone, Polyurethane
Conductor Material MP35N-DFT-28% Ag
4x8 Surgical Lead
Part Specication
Lead Lengths 50, 70 cm
Lead Shape 4 x 8 paddle
Lead Width 9 mm (tightly-spaced version),
10 mm (widely-spaced version)
Number of Electrode Contacts 32
Electrode Size - Width x Length 1 mm x 3.4 mm
Electrode Spacing (longitudinal) 1 mm (tightly-spaced version),
3.2 mm (widely-spaced version)
Contacts Material Platinum/Iridium
Insulation Material Silicone, Polyurethane
Conductor Material MP35N-DFT-28% Ag
Lead Extension
Part Specication
Extension Lengths 25, 35, 55 cm
Extension Diameter 1.3 mm
Number of Electrode Contacts 8
Contacts Material Platinum/Iridium, Stainless Steel
Insulation Material Silicone, Polyurethane
Conductor Material MP35N-DFT-28% Ag

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Registering the Leads
In accordance with international practice and regulatory legislation in some countries, a registration form is
packed with each Boston Scientic Lead/Lead Extension.
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 implanted Lead, accessory or
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
25129 Rye Canyon Loop
Valencia, California 91355, USA
Attention: Customer Service Department

Instructions for Use
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Instructions for Use
Physician training is required. Boston Scientic also recommends that implanting physicians read all
product labeling prior to using our devices.
Lead and Lead Extension Handling and Storage
• Avoid damaging the Lead with sharp instruments or excessive force during surgery.
• Do not sharply bend or kink the Lead or Extension.
• Do not tie suture(s) directly to the Lead or Extension; use the provided Suture Sleeves.
• Avoid pulling an implanted Lead taut; provide a stress relief loop at the insertion site to minimize
tension on the Lead.
• Avoid handling the Lead with sharp instruments; use only rubber-tipped forceps.
• Take care when using sharp instruments such as hemostats or scalpels to prevent damaging the
Lead.
• Wipe off any body uids from the Lead connector end before connecting it to any other component.
Fluid contamination of these connections could compromise the integrity of the stimulation circuit.
Store components between 0 °C and 45 °C (32 °F and 113 °F) in an area where they are not exposed to
liquids or excessive moisture. Temperatures outside of the stated range can cause damage.
Paddle Lead Placement in the Epidural Space
1. Determine the appropriate vertebral level for Lead placement using uoroscopic guidance.
2. Position, prep and drape the patient in the usual accepted manner.
3. Ensure adequate space prior to introducing the Paddle Lead.
OPTIONAL: A Passing Elevator or Paddle Blank may be used prior to introducing the 2x8 Paddle Lead
or 4x8 Paddle Lead into the epidural space (respectively). Select the appropriately sized Paddle Blank
for use with the 4x8 Paddle. Passing elevators and Paddle Blanks are designed to help verify that the
epidural space is cleared for placement of the Paddle Lead.
Grasp the curved area of the Passing Elevator with your ngertips. Grasp the tails of the Paddle
Blank with your ngertips as you would hold the Paddle Lead. While avoiding pressure on
the thecal sac and spinal cord, carefully and gently introduce the Passing Elevator or Paddle
Blank at a shallow angle into the epidural space along the midline. When the Passing Elevator
or Paddle Blank reaches the target site for the Lead, gently remove the elevator or blank.
CAUTION: Do not use the Passing Elevator or Paddle Blank to clear scar tissue or open up a narrow
spinal canal. Exerting excessive force may cause patient injury or breakage of the Passing Elevator.
4. Use the standard technique to introduce the Paddle Lead into the epidural space, visually ensuring that
the Contacts are facing down towards the dura.

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5. Advance the Lead to the desired location.
6. Once the Paddle Lead is at the appropriate vertebral level, use standard technique to identify Leads
and proceed to the instructions for Connecting to the OR Cable in the appropriate DFU for your SCS
system as listed in your Reference Guide.
Intraoperative Stimulation Testing
Note: The following steps are for procedural reference only. For detailed stimulation testing procedures
and guidelines refer to the appropriate programming manual for your SCS system as listed in the
Reference Guide.
1. After linking the Clinician Programmer to the Trial Stimulator, check impedances to verify that
components are properly connected. Lead impedance is measured and displayed for each of the
IPG’s Contacts. Impedances, indicated by an x or an orange circle in your Programming Software, are
considered to be resultant from open or unconnected wires. Refer to your Programming Manual for
additional information.
2. Using test stimulation, enlist patient feedback to verify Lead placement and pain coverage.
Note: If Lead repositioning is necessary, turn stimulation off before proceeding.
3. Repeat steps 1 and 2 if the Lead has been repositioned.
4. When the desired stimulation is achieved:
a) Turn the Trial Stimulator off.
b) Unlock each OR cable connector and disconnect from the Lead(s).
5. Record the Lead position by capturing a uoroscopic image to be sure the Leads have not moved.
Retest if necessary.
6. Proceed to “Anchoring the Lead.”
Note: Before receiving a permanent SCS system, it is recommended that patients undergo a trial
procedure so that they can experience stimulation to evaluate if SCS is effective at treating their
chronic pain.
Anchoring the Lead
Leads can be permanently anchored with a Suture Sleeve or with an anchor. Refer to the Directions for
Use for your Boston Scientic anchor as listed in your Reference Guide, or continue with the following
steps to anchor using a Suture Sleeve.
1. Place a Suture Sleeve over the Lead and down to the supraspinous ligament or deep fascial tissue.

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2. Ligate the Suture Sleeve onto the Lead by tying a 2-0 silk or other nonabsorbable suture around the
center groove of the sleeve to prevent sliding. Circumferential stitches may be tied at the compression
slots.
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 or
result in Lead fracture.
Note: The 4 cm and 2.3 cm Suture Sleeves each have three (3) compression slots, which are designed
to reduce slippage.
3. Suture the sleeve to the supraspinous ligament or deep fascia through the Suture Sleeve holes.
4. Tie multiple sutures as tightly as possible around the Suture Sleeve to secure it to the Lead.
CAUTION: Tightening sutures directly on the Lead can damage the Lead.
5. For Permanent Trials, proceed to the instructions for “Tunneling the Lead or Lead Extension” on page 7.
6. For Permanent IPG Implantation, proceed to the instructions for “IPG Implantation” in the appropriate
DFU for your SCS system as listed in your Reference Guide.
Example of 4x8 Surgical Lead secured by two anchors:
Tunneling the Lead or Lead Extension
Note: If using a 4x8 Surgical Lead, it is recommended to use the Long Tunneling Tool (35cm).
1. Attach the tunneling tool handle to the shaft by turning the locking mechanism clockwise.

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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.
5. Make a small incision at the desired exit site.
6. Create a subcutaneous tunnel between the midline incision and the exit site until the straw is visible
and accessible at the exit point.
7. Unscrew and remove the tunneling tool handle.

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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 proximal ends through the straw, then withdraw the straw.
10. For Permanent Trials, proceed to “Connecting the Lead Extension” on page 9.
11. For Permanent IPG Implantation, if Extensions are used, proceed to the instructions for “Connecting
the Lead Extension” on page 9.
12. For Permanent IPG Implantation, refer to instructions for connecting to the IPG in the appropriate DFU
for your SCS system as listed in your Reference Guide.
Note: The following Codman Disposable Catheter Passers may be used in place of the Boston Scientic
tunneling tool for the 2x8 Surgical Lead only:
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 IPG pocket to the midline
incision using the standard technique.
Connecting the Lead Extension
1. Wipe clean the proximal end of the Lead, then insert the proximal end into the Lead Extension
connector until it stops and the retention ring (long ring) is under the Setscrew.
Note: If there appears to be an obstruction when inserting the Lead into the Lead Extension connector,
use the Hex Wrench to loosen (counterclockwise) the Setscrew and/or gently rotate the Lead to
help advance the proximal end.
2. Ensure that the Lead is fully inserted before tightening the Setscrew to prevent Lead damage.
3. Using the Hex Wrench supplied, turn the Extension connector Setscrew clockwise until it clicks,
indicating lock.
Note: • Ensure that the Hex Wrench is fully seated in the Setscrew before tightening.
• The Hex Wrench is torque-limited and cannot be overtightened.
4. Form an appropriately-sized pocket using blunt dissection on either side of midline for coiled excess
Lead and Extension connectors.
5. Place a small loop at the Lead for slack. If necessary, loosely tie a suture around the Lead-loop, but do
not tighten onto the Lead.

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CAUTION: Tightening sutures directly on the Lead can damage the Lead.
6. Carefully remove excess slack by gently pulling the Extensions from the exit wound.
7. For permanent trials, if desired, a small suture may be used to close the exit wound of the Extension.
Place and tape a stress relief loop and dress the wound. Proceed to instructions for connecting to the
OR Cable Connector in the appropriate DFU for your SCS System as listed in your Reference Guide.
8. For a Permanent Implant, close the midline incision, and proceed to instructions for connecting to the
IPG in the appropriate DFU for your SCS System as listed in your Reference Guide.

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Mode d'emploi des sondes chirurgicales
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Garanties
Boston Scientic Corporation se réserve le droit de modier, sans préavis, les informations relatives à ses
produits dans le but d'améliorer leur abilité ou leur capacité de fonctionnement.
Les dessins et schémas sont présentés à des ns d'illustration uniquement.
Marques commerciales
Toutes les marques commerciales citées appartiennent à leurs détenteurs respectifs.
Informations supplémentaires
Pour connaître les indications et les informations connexes, consulter les Indications d'utilisation ou le
Manuel destiné aux médecins de votre système de stimulation médullaire. Pour les contre-indications,
avertissements, précautions, le résumé des effets indésirables, les instructions destinées aux médecins,
les règles de stérilisation et de mise au rebut des composants et les coordonnées de Boston Scientic,
veuillez consulter le Manuel d'informations destiné aux prescripteurs ou le Manuel destiné aux médecins
de votre système de stimulation médullaire. Pour toute autre information spécique à l'appareil non
présente dans ce manuel, les symboles qui apparaissent sur les étiquettes et la garantie, consulter
le manuel approprié de votre système de stimulation médullaire, comme indiqué dans votre Guide de
référence.
Références des produits
Modèle Description
SC-3138-xx Kit de prolongation de sonde à 8 contacts xxcm
SC-8120-xx Kit de sonde chirurgicale ArtisanTM xxcm 2x8
SC-8216-xx Kit de sonde chirurgicale Artisan xxcm 2x8
SC-8416-xx Kit de sonde chirurgicale Artisan MRI xxcm 2x8
SC-8336-xx Kit de sonde chirurgicale CoverEdgeTM 32 xxcm 4x8
SC-8436-xx Sonde chirurgicale à palette CoverEdge MRI 32
SC-8352-xx Kit de sonde chirurgicale CoverEdge X 32 xxcm 4x8
SC-8452-xx Sonde chirurgicale à palette CoverEdge X MRI 32
Remarque : xx se réfère à la longueur (cm).

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Table des matières
Description.................................................................................................................................... 15
Sondes à palettes chirurgicales ................................................................................................ 15
Sonde chirurgicale à palette 2x8............................................................................................... 15
Sonde chirurgicale à palette 4x8............................................................................................... 15
Extension de sonde................................................................................................................... 15
Contenu de l'emballage ............................................................................................................... 16
Kit de prolongation de sonde .................................................................................................... 16
Kit de sonde chirurgicale à palette 2x8 ..................................................................................... 16
Kit de sonde chirurgicale à palette 4x8 ..................................................................................... 16
Caractéristiques et données techniques ................................................................................... 17
Sonde chirurgicale 2x8.............................................................................................................. 17
Sonde chirurgicale 4x8.............................................................................................................. 17
Extension de sonde................................................................................................................... 17
Enregistrement des sondes ........................................................................................................ 18
Mode d'emploi .............................................................................................................................. 19
Manipulation et stockage de la sonde et de la prolongation de sonde ..................................... 19
Positionnement de la sonde à palette dans l'espace épidural .................................................. 19
Essais de stimulation peropératoires ........................................................................................ 20
Ancrage de la sonde ................................................................................................................. 20
Tunnellisation de la sonde ou de la prolongation...................................................................... 21
Connexion de la sonde-extension............................................................................................. 23

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Description
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Description
Les Sondes à palette chirurgicales fonctionnent en tant que composants des systèmes de Stimulateur
médullaire (SCS) de Boston Scientic en délivrant une stimulation électrique aux structures nerveuses
dans le segment dorsal de la moelle épinière, avec pour effet une inhibition de la sensation de douleur.
Sondes à palettes chirurgicales
Sonde chirurgicale à palette 2x8
La sonde chirurgicale 2x8 est disponible en deux longueurs (50 et 70 cm). Son extrémité distale (palette)
présente deux colonnes de huit électrodes planaires en platine espacées uniformément. Chaque
électrode a une taille de 3x2 mm. À son extrémité proximale, cette sonde possède 2 extrémités de sonde.
L'extrémité de chaque queue présente huit contacts espacés uniformément. La queue droite de la sonde
à palette est gravée au laser pour faciliter l'identication de la droite et la gauche. Chaque queue peut être
insérée dans un GII ou une sonde-extension.
Sonde chirurgicale à palette 4x8
Les sondes chirurgicales 4x8 CoverEdge™ sont disponibles en longueurs de 50 cm et 70 cm avec des
électrodes très rapprochées ou très espacées. L'extrémité distale (palette) de la sonde présente quatre
colonnes de 8 électrodes planaires espacées uniformément. Chaque électrode a une taille de 1x3,4 mm.
À son extrémité proximale, cette sonde possède 4 extrémités. L'extrémité de chaque queue présente
8 contacts espacés uniformément. Chaque queue de la sonde à palette est identiée de manière unique
par des bandes repères. En allant de gauche à droite, avec les électrodes orientées vers le bas, la
première queue présente une seule bande repère, la deuxième en présente deux, la troisième trois et
la quatrième présente quatre bandes repères. Chaque queue correspond à la colonne respective de
contacts sur la palette. Chaque queue peut être insérée dans un GII ou une sonde-extension.
Remarque : la sonde chirurgicale 4x8 est destinée à être utilisée avec les Stimulateurs SCS Boston
Scientic à 4 ports.
Extension de sonde
Les prolongations de sonde sont conçues pour relier les sondes percutanées et les sondes à palette
au GII pour la stimulation médullaire. La prolongation peut être connectée à une sonde en vue de
l'externaliser lors d'une procédure d'essai ou de la prolonger en cas d'implantation d'un GII permanent.
Les prolongations de sonde sont disponibles dans des longueurs de 25 cm, 35 cm et 55 cm. La
prolongation peut être connectée au stimulateur d'essai (via un câble de salle d'opération) ou directement
à un GII.