Boston Scientific Spinal Cord Stimulation (SCS) Systems
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1 Boston Scientific Spinal Cord Stimulation (SCS) Systems REV B
2 Boston Scientific Spinal Cord Stimulator Systems - Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Trademarks All trademarks are the property of their respective holders REV B ii of ii
3 Introduction Introduction The provides the list of Directions for Use (DFU) available for each Boston Scientific Spinal Cord Stimulator System. These manuals are designed for clinicians and other health care providers. IMPORTANT: Please note that only the Directions for Use that are appropriate for your region will be provided with your SCS system. Additional information may be provided in addendums to these DFUs. How to Use this In this, DFUs are listed for each Spinal Cord Stimulator System in a table format. Follow the instructions below to find information for your SCS system: 1. Find the appropriate table for your SCS system. For example, if you are using a Precision Spectra System, find the table labelled Precision Spectra Directions for Use. 2. Use the highlighted rows to locate the information of interest to you (e.g. indications, implantable pulse generator, or programming). The DFU containing this information is listed below. The Boston Scientific DFUs are provided either online (as directed in your product packaging) or with your SCS system REV B 1 of 13
4 Boston Scientific Spinal Cord Stimulator Systems - Precision SCS System Directions for Use Information Intended Use/Indications for Use Indications for use Contraindications, Safety Information, General Device Information Adverse Events Summary Contraindications Precautions Warnings Physician Instructions Sterilization Component Disposal Information for contacting Boston Scientific Precision Implantable Pulse Generator Compatible Leads Connecting to the IPG IPG Battery Life IPG Explant or Replacement IPG Handling and Storage IPG Implantation Kit Contents IPG Registration Information IPG Specifications and Technical Data OR Cables, OR Cable Extension, External Trial Stimulator Connecting the Leads, Lead Extensions, or Splitter to the OR Cable Connection to the External Trial Stimulator Patient Trial Belt instructions for use Directions for Use Precision Spinal Cord Stimulator System Clinician Manual Percutaneous Leads, Extensions, and Splitters Intraoperative testing using the OR Cable Assembly and External Trial Stimulator List of percutaneous Leads for trial and permanent implant Storage and handling for leads, extensions, and splitters Precision Spinal Cord Stimulator System Clinician Manual OR Percutaneous Leads DFU REV B 2 of 13
5 Precision SCS System Directions for Use Surgical Leads Intraoperative testing with OR Cable Assembly and External Trial Stimulator List of surgical leads Storage and handling for leads and extensions Programming Clinician Programmer Programming with the Bionic Navigator software Remote Control Instructions for Use Connection of the External Trial Stimulator to the Clinician Programmer Adapters Precision Spinal Cord Stimulator System Clinician Manual OR Surgical Leads Leads DFU Bionic Navigator Software Guide Precision Spinal Cord Stimulator System Clinician Manual M1 Connector M1 Connector DFU Precision M8 Adapter Precision M8 Adapter DFU Precision S8 Adapter Precision S8 Adapter DFU OMG Connector-A OMG Connector-A DFU OMG Connector-M OMG Connector-M DFU Surgical Tools and Accessories Clik Anchor Clik Anchor DFU Clik X Anchor Clik X Anchor DFU Introducer instructions for use Introducer DFU Med A instructions for use Med A DFU Warranty Warranty information Limited Warranty Labeling Symbols Labeling Symbols Labeling Symbols REV B 3 of 13
6 Boston Scientific Spinal Cord Stimulator Systems - Precision Montage MRI SCS System Directions for Use Information Directions for Use Intended Use/Indications for Use Indications for use Indications for Use DFU Contraindications, Safety Information, General Device Information Adverse Events Summary Battery Life Component Disposal Contraindications Device Description Electromagnetic Interference End of Programmed Service Information for contacting Boston Scientific IPG Battery Life MRI Information Physician Instructions Precautions Sterilization Storage and Handling Telemetry Information Warnings Precision Montage ImageReady MRI Guidelines ImageReady MRI Full Body Guidelines for Precision Montage MRI SCS System Precision Montage Implantable Pulse Generator (IPG) Compatible Leads Connecting to the IPG IPG Battery Status IPG Explant or Replacement IPG Handling and Storage IPG Implantation IPG Registration Information Specifications and Technical Data SCS Implant Conditions for MRI Eligibility Precision Montage MRI Information for Prescribers DFU ImageReady MRI Full Body Guidelines for Precision Montage MRI SCS System Precision Montage MRI Implantable Pulse Generator DFU REV B 4 of 13
7 Precision Montage MRI SCS System Directions for Use OR Cable, OR Cable Extensions, External Trial Stimulator, Patient Trial Belt Connection to the External Trial Stimulator Inserting Leads, Lead Extensions, or Splitter into the OR Cable Connector -- 1x16 OR Cable Clinician Trial Manual -- 2x8 OR Cable Patient Trial Belt instructions for use Programming: Clinician Programmer, Wand, and Remote Control Clinician Programmer Programming leads Bionic Navigator 3D Programming Manual (DFU) Connection of the Clinician Programmer to the External Trial Stimulator by Programming Wand Programming Wand DFU Instructions for using the remote control (SC-5250) Freelink Remote Control DFU for SC-5250 Avista MRI Leads Intraoperative testing using the OR Cable Assembly and External Trial Stimulator Storage and handling for MRI leads SCS Implant Conditions for MRI Eligibility Percutaneous Leads Intraoperative testing using the OR Cable Assembly and External Trial Stimulator List of percutaneous Leads for trial and permanent implant Storage and handling for leads, extensions, and splitters Surgical Leads Intraoperative testing with OR Cable Assembly and External Trial Stimulator List of surgical leads Storage and handling for leads and extensions Avista MRI Percutaneous Leads DFU Percutaneous Leads DFU Surgical Leads DFU REV B 5 of 13
8 Boston Scientific Spinal Cord Stimulator Systems - Surgical Tools and Accessories Clik X MRI Anchor Clik X MRI Anchor DFU Clik X Anchor Clik X Anchor DFU Clik Anchor Clik Anchor DFU Introducer instructions for use Introducer DFU Med A instructions for use Med A DFU Warranty Warranty information Limited Warranty Labeling Symbols Labeling Symbols Labeling Symbols REV B 6 of 13
9 Precision Novi SCS System Directions for Use Precision Novi SCS System Directions for Use Information Directions for Use Intended Use/Indications for Use Indications for use Indications for Use DFU Contraindications, Safety Information, General Device Information Adverse Events Summary Contraindications Component Disposal Device Description Elective Replacement End of Service Estimating Battery Longevity Information for contacting Boston Scientific IPG Battery Life MRI Information Physician Instructions Precautions Sterilization Storage and Handling Telemety Warnings Precision Novi Implantable Pulse Generator (IPG) Precision Novi Information for Prescribers DFU Compatible Leads Connecting to the IPG IPG Battery Life IPG Explant or Replacement IPG Handling and Storage IPG Implantation IPG Registration Information Specifications and Technical Data Precision Novi Implantable Pulse Generator DFU OR Cable, OR Cable Extensions, External Trial Stimulator, Patient Trial Belt Connection to the External Trial Stimulator Inserting Leads, Lead Extensions, or Splitter into the OR Cable Connector -- 1x16 OR Cable -- 2x8 OR Cable Patient Trial Belt instructions for use Clinician Trial Manual REV B 7 of 13
10 Boston Scientific Spinal Cord Stimulator Systems - Programming: Clinician Programmer, Wand, and Remote Control Clinician Programmer Programming Leads Connection of the Clinician Programmer to the External Trial Stimulator by Programming Wand Bionic Navigator 3D Programming Manual DFU Programming Wand DFU Instructions for using the remote control (SC-5240) Freelink Remote Control DFU for SC-5240 Instructions for using the remote control (SC-5250) Freelink Remote Control DFU for SC-5250 Percutaneous Leads, Extensions, and Splitters Intraoperative testing using the OR Cable Assembly and External Trial Stimulator List of percutaneous Leads for trial and permanent implant Storage and handling for leads, extensions, and splitters Percutaneous Leads DFU Surgical Leads Intraoperative testing with OR Cable Assembly and External Trial Stimulator List of surgical leads Storage and handling for leads and extensions Surgical Leads DFU Adapters M1 Connector M1 Connector DFU Precision M8 Adapter Precision M8 Adapter DFU Precision S8 Adapter Precision S8 Adapter DFU Surgical Tools and Accessories Clik Anchor Clik Anchor DFU Clik X Anchor Clik X Anchor DFU Introducer instructions for use Introducer DFU Med A instructions for use Med A DFU Warranty Warranty information Limited Warranty Labeling Symbols Labeling Symbols Labeling Symbols REV B 8 of 13
11 Precision Spectra SCS System Directions for Use Precision Spectra SCS System Directions for Use Information Directions for Use Intended Use/Indications for Use Indications for use Indications for Use DFU Contraindications, Safety Information, General Device Information Adverse Events Summary Component Disposal Contraindications Device Description Electromagnetic Interference End of Programmed Service Information for contacting Boston Scientific MRI Information IPG Battery Life Physician Instructions Precautions Sterilization Storage and Handling Warnings Precision Spectra Implantable Pulse Generator (IPG) Precision Spectra Information for Prescribers DFU Compatible Leads Connecting to the IPG IPG Battery Status IPG Explant or Replacement IPG Handling and Storage IPG Implantation IPG Registration Information Specifications and Technical Data Precision Spectra Implantable Pulse Generator DFU Precision Spectra ImageReady MRI Guidelines ImageReady MRI Guidelines ImageReady MRI Head Only Guidelines for Precision Spectra Spinal Cord Stimulator System REV B 9 of 13
12 Boston Scientific Spinal Cord Stimulator Systems - OR Cable, OR Cable Extensions, External Trial Stimulator, Patient Trial Belt Connection to the External Trial Stimulator Inserting Leads, Lead Extensions, or Splitter into the OR Cable Connector -- 1x 16 OR Cable Clinician Trial Manual -- 2x8 OR Cable Patient Trial Belt instructions for use Programming: Clinician Programmer, Wand, and Remote Control Clinician Programmer Programming leads Bionic Navigator 3D Programming Manual (DFU) Connection of the Clinician Programmer to the External Trial Stimulator by Programming Wand Programming Wand DFU Instructions for using the remote control (SC-5240) Freelink Remote Control DFU for SCS-5240 Instructions for using the remote control (SC-5250) Freelink Remote Control DFU for SC-5250 Instructions for using the remote control (SC-5232) Percutaneous Leads, Extensions, and Splitters Intraoperative testing using the OR Cable Assembly and External Trial Stimulator List of percutaneous Leads for trial and permanent implant Storage and handling for leads, extensions, and splitters Precision Spectra System Clinician Remote Control DFU Percutaneous Leads DFU Surgical Leads Intraoperative testing with OR Cable Assembly and External Trial Stimulator List of surgical leads Storage and handling for leads and extensions Surgical Leads DFU Adapters M1 Connector M1 Connector DFU Precision Spectra OMG Adapter Precision Spectra OMG Adapter DFU Precision M8 Adapter Precision M8 Adapter DFU Precision S8 Adapter Precision S8 Adapter DFU REV B 10 of 13
13 Precision Spectra SCS System Directions for Use Surgical Tools and Accessories Clik Anchor Clik Anchor DFU Clik X Anchor Clik X Anchor DFU Introducer instructions for use Introducer DFU Med A instructions for use Med A DFU Warranty Warranty information Limited Warranty Labeling Symbols Labeling Symbols Labeling Symbols REV B 11 of 13
14 Boston Scientific Spinal Cord Stimulator Systems - Argentina T: F: Australia / New Zealand T: , F: Austria T: F: Balkans T: F: Belgium T: F: Brazil T: F: Bulgaria T: F: Canada T: F: Chile T: F: China Beijing T: F: China Guangzhou T: F: China Shanghai T: F: Colombia T: F: Czech Republic T: F: Denmark T: F: Finland T: F: France T: +33 (0) F: +33 (0) Germany T: F: Greece T: F: Hong Kong T: F: Hungary T: F: India Bangalore T: /5 F: India Chennai T: F: India Delhi T: /6 F: India Mumbai T: F: Italy T: F: Korea T: F: Malaysia T: F: Mexico T: F: Middle East / Gulf / North Africa T: F: The Netherlands T: F: Norway T: F: Philippines T: F: Poland T: F: Portugal T: F: Singapore T: F: South Africa T: F: Spain T: F: Sweden T: F: Switzerland T: F: Taiwan T: F: Thailand T: F: Turkey Ankara T: F: Turkey Istanbul T: F: Uruguay T: F: UK & Eire T: F: Venezuela T: F: REV B 12 of 13
15 Precision Spectra SCS System Directions for Use This page intentionally left blank REV B 13 of 13
16 Legal Manufacturer Boston Scientific Neuromodulation Rye Canyon Loop Valencia, CA USA (866) in US and Canada (661) , (661) Fax (866) TTY AUS Australian Sponsor Address Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone Free Fax EU Authorised Representative Boston Scientific Limited Ballybrit Business Park Galway, Ireland T: +33 (0) F: +33 (0) Boston Scientific Corporation or its affiliates. All rights reserved REV B
Limited Warranty. CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
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