Boston Scientific WaveWriter Alpha Series Manual

WaveWriter Alpha™
and
WaveWriter Alpha™ Prime
Implantable Pulse Generators
Directions for Use
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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. 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

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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

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Description
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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.

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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
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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

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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
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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.

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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.