Boston Scientific WaveWriter Alpha Series Manual

WaveWriter Alpha™
and
WaveWriter Alpha™ Prime
Implantable Pulse Generators
Directions for Use
92469342-02
Content: MP92469342-02 REV A
en fr de nl es it pt-EU el no da sv cs sk hu pl bg hr ro sl
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

Implantable Pulse Generator
Implantable Pulse Generator
92469342-02 ii of iv
en
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. 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 system. For
other device-specic instructions not included in this manual, labeling symbols, and warranty information,
refer to the appropriate DFU as listed in your Reference Guide.
For information on programming interactions, refer to the appropriate Programming Manual as listed in
your Reference Guide.
For SCS Implant conditions for MRI eligibility, refer to the appropriate MRI guidelines manual for your SCS
system as listed in your Reference Guide.
Product Model Number
Model Number Description
SC-1216 WaveWriter Alpha™ 16 Implantable Pulse Generator Kit
SC-1232 WaveWriter Alpha™ Implantable Pulse Generator Kit
SC-1416 WaveWriter Alpha™ Prime 16 Implantable Pulse Generator Kit
SC-1432 WaveWriter Alpha™ Prime Implantable Pulse Generator Kit

Implantable Pulse Generator
92469342-02 iii of iv
en
Table of Contents
Description........................................................................................................................................................................ 1
Radiopaque Identication Tag ...................................................................................................................................... 1
Compatible Leads ........................................................................................................................................................ 1
Compatible Leads for Full Body MRI Eligibility ............................................................................................................ 2
Package Contents ............................................................................................................................................................ 3
WaveWriter Alpha and WaveWriter Alpha Prime IPG Kit ............................................................................................. 3
WaveWriter Alpha 16 and WaveWriter Alpha Prime 16 IPG Kit ................................................................................... 3
Specications and Technical Data.................................................................................................................................. 4
Materials............................................................................................................................................................................ 4
Instructions for Use.......................................................................................................................................................... 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, Lead Extension, Splitter, or Connector to the 16 Contact IPG .................................................. 9
Connecting to the IPG .................................................................................................................................................. 9
Connecting the Lead, Lead Extension, Splitter, or Connector to the 32 Contact IPG ................................................ 10
IPG Explant or Replacement ..................................................................................................................................... 12
Rechargeable Stimulator System ................................................................................................................................. 12
Charging Steps .......................................................................................................................................................... 12
IPG Battery Status ..................................................................................................................................................... 13
Non Rechargeable Stimulator System ......................................................................................................................... 14

Implantable Pulse Generator
Implantable Pulse Generator
92469342-02 iv of iv
en
This page intentionally left blank.

Description
Implantable Pulse Generator
92469342-02 1 of 353
en
Description
The WaveWriter Alpha™, WaveWriter Alpha™ 16, WaveWriter Alpha™ Prime, and WaveWriter Alpha™
Prime 16 Implantable Pulse Generators (IPG) are intended to treat chronic pain by electrically stimulating
the spinal cord or peripheral nerves. The multi-channel, multi-electrode device capability provides exibility
in conjunction with ease of programming. The IPGs are controlled by a handheld Remote Control, and can
be engaged by a Clinician Programmer using proprietary programming software.
Radiopaque Identication Tag
The IPG contains a radiopaque identication tag. The identication tag is visible using standard x-ray
procedures and will help identify the device model number without performing a surgical operation.
SC-1216 SC-1232 SC-1416 SC-1432
WaveWriter Alpha and WaveWriter Alpha 16 IPGs are rechargeable. References to the Charging System
or charging process are applicable only when using a rechargeable SCS IPGs. WaveWriter Alpha Prime
and WaveWriter Alpha Prime 16 IPGs are non-rechargeable.
Compatible Leads
• Artisan™ 2x8 Surgical Leads
• Artisan MRI xxcm 2x8 Surgical Lead
• Avista™ MRI xxcm 8 Contact Lead
• CoverEdge™ 32 xx cm 4x8 Surgical Lead
• CoverEdge X 32 xx cm 4x8 Surgical Lead
• CoverEdge MRI 32 xx cm 4x8 Surgical Lead
• CoverEdge X MRI 32 xx cm 4x8 Surgical Lead
• Innion™ 16 xx cm 16 Contact Lead
• Innion CX xx cm 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
• Precision M8 Adapter
• Precision S8 Adapter
• 8 Contact Extensions
• 2x4 Splitters
• 2x8 Splitters
Note: xx denotes length (cm).
The WaveWriter Alpha 16 and WaveWriter Alpha Prime 16 Systems support any combination of 8 Contact
percutaneous, 16 Contact percutaneous, or 16 Contact Surgical Leads totaling up to 16 active Contacts.

Implantable Pulse Generator
Implantable Pulse Generator
92469342-02 2 of 353
en
The WaveWriter Alpha and WaveWriter Alpha Prime Systems support any combination of 8 Contact
percutaneous, 16 Contact percutaneous, and 16 and 32 Contact Surgical Leads totaling up to 32 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” section 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 appropriate Boston
Scientic SCS System.
Compatible Leads for Full Body MRI Eligibility
• Artisan™ xx cm 2x8 Surgical Lead
• Artisan MRI xx cm 2x8 Surgical Lead
• Avista™ MRI xxcm 8 Contact Lead
• CoverEdge™ 32 xx cm 4x8 Surgical Lead
• CoverEdge X 32 xx cm 4x8 Surgical Lead
• CoverEdge MRI 32 xx cm 4x8 Surgical Lead
• CoverEdge X MRI 32 xx cm 4x8 Surgical 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

Package Contents
Implantable Pulse Generator
92469342-02 3 of 353
en
Package Contents
WaveWriter Alpha and WaveWriter Alpha Prime IPG Kit
Description Quantity
32 Contact Implantable Pulse Generator 1
Hex Wrench 1
IPG Pocket Template 1
Port Plugs 4
WaveWriter Alpha 16 and WaveWriter Alpha Prime 16 IPG Kit
Description Quantity
16 Contact Implantable Pulse Generator 1
Hex Wrench 1
IPG Pocket Template 1
Port Plugs 2

Implantable Pulse Generator
Implantable Pulse Generator
92469342-02 4 of 353
en
Specications and Technical Data
Parameter Range Default
Areas (Channels) 4 —
Amplitude 0 – 25.5 mA 0 mA
Rate 2 Hz – 1200 Hz 40 Hz
Width 20 – 1000 μsec 210 μsec
Cycle 0 sec – 90 min OFF
Ramp Up 1 – 10 secs
-or-
OFF
3 secs
Contacts (16-Contact IPG) 1 – 16, case: +100% to -100%,
OFF
1 – 16, case: OFF
Contacts (32-Contact IPG) 1 – 32, case: +100% to -100%,
OFF
1 – 32, case: OFF
Materials
Case Titanium
Header Epoxy
Strain Relief Silicone
Size/Volume
(including header)
WaveWriter Alpha Prime (32 Contacts): 75mm x 49.6mm X 11.6mm/36.6 cm3
WaveWriter Alpha Prime 16: 72mm x 49.6mm X 11.6mm /34.9 cm3
WaveWriter Alpha (32 Contacts): 55.6mm x 46mm X 10.7mm /21.6 cm3
WaveWriter Alpha 16: 52.1mm x 46mm X 10.7mm /20.1 cm3

Instructions for Use
Implantable Pulse Generator
92469342-02 5 of 353
en
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 the appropriate Boston Scientic 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.
• If using the Avista MRI Lead(s), 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 the appropriate Boston Scientic 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 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.

Implantable Pulse Generator
Implantable Pulse Generator
92469342-02 6 of 353
en
Pre-Op Instructions
1. For rechargeable IPGs, 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. See”Charging Steps” section in this manual for additional instructions.
2. Check that the sterile package is intact. (See “Sterilization” section in the Information for Prescribers
manual.)
3. If intraoperative stimulation testing is desired, ensure that an External Trial Stimulator (ETS) is
available for use. Ensure that stimulation is off (the ETS indicator light is not blinking) before opening
the battery compartment of the ETS. 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.
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. Using the IPG Pocket Template, select and mark the intended IPG site, and create an incision for the
IPG pocket.
4. Create a subcutaneous pocket no larger than the IPG outline. For non-rechargeable IPGs, implant
at a depth of up to 2.5 cm from the surface. For Rechargeable IPGs, implant charging could become
ineffective at depths shallower than 0.5 cm or greater than 2.0 cm.
Note: Using the IPG Pocket 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.
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” section in this manual).
5. Tunnel the Lead(s) to the IPG site.

Instructions for Use
Implantable Pulse Generator
92469342-02 7 of 353
en
Tunneling the Lead or Lead Extension
Tunneling Tool Assemblies (SC-4254 and SC-4252) are sold separately. If using a 4x8 Surgical Lead or
Innion CX Lead, we recommend using the 35 cm Long Tunneling Tool (SC-4254).
Note: The following Codman Disposable Catheter Passers may be used in place of the Boston Scientic
tunneling tool: REF 82-1515 (36 cm); REF 82-1516 (55 cm); REF 82-1517 (65 cm) When using a
Codman Disposable Catheter Passer, tunnel from the midline or anchor incision to the IPG pocket
using the standard technique.
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.
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.

Implantable Pulse Generator
Implantable Pulse Generator
92469342-02 8 of 353
en
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 Lead 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.
CAUTION: Do not tunnel the Splitter.
Note: If using the 2x8 Splitter and performing a permanent trial, the Splitter tails may be tunneled to the
exit site.

Instructions for Use
Implantable Pulse Generator
92469342-02 9 of 353
en
Connecting the Lead, Lead Extension, Splitter, or Connector to the 16 Contact IPG
Note: Lead Extensions, Adapters, and Splitters are not full-body MRI scan eligible.
IPG ports are labeled as follows:
CD
Connecting to the IPG
• Leads connect to IPG ports C or D.
• For the Innion 16, connect the Splitter tail with laser-etched bands (Contacts 1-8 of the Innion 16
Lead) to the left Port C and the unmarked Splitter tail (Contacts 9-16 of the Innion 16 Lead) to the
right Port D.
• For the Innion CX Lead, connect the tail with the single marker band (Contacts 1-8 of the Innion
CX Lead) to the Port C and the tail with two marker bands (Contacts 9-16 of the Innion CX Lead
to the right Port D.
• For the Artisan and Artisan MRI 2x8 Surgical Leads, connect the left side to the left Port C. Connect
the right side (the laser-etched tail), Contacts 9-16, to the right port D.

Implantable Pulse Generator
Implantable Pulse Generator
92469342-02 10 of 353
en
Connecting the Lead, Lead Extension, Splitter, or Connector to the 32 Contact IPG
Note: Lead Extensions, Adapters, and Splitters are not full-body MRI scan eligible.
IPG ports are labeled as follows:
D
AB
C
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 Innion™ 16, connect the Splitter tail with laser etched bands (Contacts 1-8 of the Innion
16 Lead) to the left Ports A or C and the unmarked Splitter tail (Contacts 9-16 of the Innion 16
Lead) to the right Ports B or D.
• For the Innion CX Lead, connect the tail with the single marker band (Contacts 1-8 of the Innion
CX Lead) to the left Ports A or C and the tail with two marker bands (Contacts 9-16 of the Innion
CX 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.
• For the 4x8 Surgical Lead, connect the Lead tail as follows to the 32 Contact IPG:
- Lead tail with one marker band (Contacts 1-8) to Port A.
- Lead tail with two marker bands (Contacts 9-16) to Port B.
- Lead tail with three marker bands (Contacts 17-24) to Port C.
- Lead tail with four marker bands (Contacts 25-32) to Port D.
Example: 4x8 Surgical Lead (electrodes faced down)
4
3
2
1
8
7
6
5
1 Contacts 1-8 5Connects to port A
2Contacts 9-16 6Connects to port B
3Contacts 17-24 7Connects to port C
4Contacts 25-32 8 Connects to port D

Instructions for Use
Implantable Pulse Generator
92469342-02 11 of 353
en
1. Fully insert the Leads, Lead Extensions, Splitters, and/or Connector(s) into the IPG Ports, 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.
Note: Lead Extensions, Adapters, and Splitters are not full-body MRI scan eligible.
2. Fully insert a Port Plug into unused IPG Ports.
Note: If you experience difculty when inserting the Lead, Lead Extension, Splitter, Connector, or Port
Plug, use the Hex Wrench to loosen (counterclockwise) the Setscrew and/or gently rotate the Lead
to help advance the proximal end.
Note: To conrm good connections, check impedances before tightening the Setscrew. 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 Setscrew until the Hex Wrench “clicks,” indicating lock.
CAUTION: Ensure that the Lead is fully inserted before tightening the Setscrew to prevent Lead
damage
Note: If a Port Plug is used, it is still necessary to tighten the Setscrew 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.
6. If desired, secure the IPG in the pocket by suturing through the holes in the IPG header.
CAUTION: Do not Suture through the Leads or Splitter.
CAUTION: Tightening Sutures directly on the Lead can damage the Lead. In addition, during an MRI
scan, the patient could be at risk of tissue heating, resulting in tissue damage or serious patient injury.
7. Close and dress the wound(s).

Implantable Pulse Generator
Implantable Pulse Generator
92469342-02 12 of 353
en
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 Setscrews to release and remove the Leads, Lead Extensions, or Splitters.
4. For replacement, connect the new IPG following the instructions for “Connecting the Lead, Lead
Extension, Splitter, or Connector to the 16 Contact IPG” on page 9. Or, to terminate therapy,
surgically remove the implanted Lead system.
5. Notify Boston Scientic to document the reason for explant or replacement and to arrange for return of
IPG and components.
Rechargeable Stimulator System
The WaveWriter Alpha and WaveWriter Alpha 16 IPGs are rechargeable. Boston Scientic recommends
any recharge routine that ts the patient’s schedule and lifestyle while maintaining sufcient charge to
maintain stimulation.
Developing a patient’s recharge routine involves 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 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 Charger Handbook
and the Clinician Remote Control Directions for Use for additional information. The recharging process is
simple, but important.
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 Pad, as shown, may result
in a burn. If pain or discomfort is felt, cease charging and contact Boston Scienti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 IPG.
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 IPG.
3. Place the Charger over the IPG. When the Charger is aligned with the IPG, the beeping will stop.
• Centering the Charger over the IPG 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.

Rechargeable Stimulator System
Implantable Pulse Generator
92469342-02 13 of 353
en
• 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 IPG by using either an Adhesive Pad or the Charger Belt.
• Adhesive Pad: Remove the clear liner from the pad. Apply the white side with the blue stripe to
the back of the Charger. Then remove the beige liner from the pad. 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.
Note: If you accidentally apply the pad in the wrong location, or if the Charger Belt moves out of
alignment, the Charger will start beeping again. Use a new Adhesive Pad 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 Pad, 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 IPG.
Note: • The end-of-a-charge signal is a distinct double beep, and the alignment indicator is a steady
continuous signal.
• The Remote Control or the Clinician Programmer 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 IPG battery life.
IPG Battery Status
The patient Remote Control displays the IPG battery status when communicating with the IPG. Refer
to the Clinician Remote Control Directions for Use for additional information. When the Remote Control
indicates a low battery the IPG 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 IPG will also cease. Until a sufcient level of charge has been attained, the IPG
may not communicate with the Remote Control.

Implantable Pulse Generator
Implantable Pulse Generator
92469342-02 14 of 353
en
Non Rechargeable Stimulator System
For information on battery longevity, see the Information for Prescribers manual. The Clinician Programmer
and the patient remote control provide notice when the IPG battery has entered Elective Replacement
Mode and when the IPG battery has reached its end of service (EOS). Refer to the Programming Manual
and the Remote Control Directions for Use for additional information.
Failure to replace the IPG may lead to reduced programming capabilities, limited communication with the
stimulator, and loss of stimulation.

Implantable Pulse Generator
92469342-02 15 of 353
en
This page intentionally left blank.

Générateur d'impulsions implantable
fr
Générateur d'impulsions implantable
92469342-02 16 sur 353
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, consultez les Indications d'utilisation.
Pour les contre-indications, les avertissements, les 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 Informations destinées aux médecins
de votre système. Pour toute autre instruction spécique au dispositif non présente dans ce manuel, les
symboles des étiquettes et les informations de garantie, consultez le manuel approprié, comme indiqué
dans votre Guide de référence.
Pour plus d'informations sur les interactions de programmation, reportez-vous au manuel de
programmation approprié, tel qu'il gure dans votre guide de référence.
Pour les conditions d'implantation du système de stimulation médullaire pour l'éligibilité à l'IRM, consultez
les directives IRM appropriées pour votre système de stimulation médullaire comme indiqué dans votre
Guide de référence.
Référence du produit
Numéro de
modèle
Description
SC-1216 Kit de générateur d’impulsions implantable du système WaveWriter Alpha™ 16
SC-1232 Kit de générateur d’impulsions implantable du système WaveWriter Alpha™
SC-1416 Kit de générateur d’impulsions implantable du système WaveWriter Alpha™ Prime 16
SC-1432 Kit de générateur d’impulsions implantable du système WaveWriter Alpha™ Prime