Boston Scientific WaveWriter Alpha - English; Default Chapter; Table of Contents

Information for Prescribers
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
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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
The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Boston Scientic
Neuromodulation Corporation is under license.
All other trademarks are the property of their respective owners.
Additional Information
For Indications and related information, see the Indications DFU. For other device-specic information not included in this manual, labeling symbols,
and warranty information, refer to the appropriate DFU for your Boston Scientic System as listed on your Reference Guide.
Throughout this document, the WaveWriter Alpha™ and WaveWriter Alpha™ 16 Systems will be referred to as the WaveWriter Alpha System.
WaveWriter Alpha™ Prime, and WaveWriter Alpha™ Prime 16 Systems will be referred to as the WaveWriter Alpha Prime Systems.
The WaveWriter Alpha System includes a rechargeable Implantable Pulse Generator (IPG). References to the Charging System or charging process
are applicable only for rechargeable IPGs.
The WaveWriter Alpha Prime System includes a non-rechargeable IPG.
All information included within this manual is applicable to both Spinal Cord Stimulator (SCS) and Peripheral Nerve Stimulation (PNS) therapy unless
otherwise specied.
Table of Contents
Device and Product Description ............................................................................................................................................................. 1
Contraindications ..................................................................................................................................................................................... 1
Safety Information .................................................................................................................................................................................... 1
Instructions for the Patient ........................................................................................................................................................................................1
Warnings ..........................................................................................................................................................................................................1
Precautions ......................................................................................................................................................................................................2
Adverse Effects ................................................................................................................................................................................................3
Instructions for the Physician ....................................................................................................................................................................................3
Sterilization ...............................................................................................................................................................................................................4
Technical Service ..................................................................................................................................................................................... 4
End of Programmed Service ................................................................................................................................................................... 4
IPG Battery Life ......................................................................................................................................................................................... 4
Rechargeable Systems ............................................................................................................................................................................................4
Non-Rechargeable Systems .....................................................................................................................................................................................4
Estimating Longevity (for Non-Rechargeable Systems) ...................................................................................................................................5
Elective Replacement (for Non-Rechargeable Systems) .................................................................................................................................5
Quality of Wireless Service ..................................................................................................................................................................... 5
Timing .......................................................................................................................................................................................................................5
Troubleshooting Wireless Coexistence Issues .........................................................................................................................................................5
Wireless Security ...................................................................................................................................................................................... 5
Telemetry Information .............................................................................................................................................................................. 6
Wireless Charging Information ............................................................................................................................................................... 6
Essential Performance ............................................................................................................................................................................. 6
External Trial Stimulator ...................................................................................................................................................................................6
Other External Devices ....................................................................................................................................................................................6
Electromagnetic Compatibility - EN 60601-1-2 Classication Information ......................................................................................... 6
Notice to the User Per Industry Canada Radio Standards Specications: ......................................................................................... 8
Contact Information ................................................................................................................................................................................. 9