Sterilization; Technical Service - Boston Scientific Spectra WaveWriter Informacion Para Medicos

Information for Prescribers

Sterilization

All Spectra WaveWriter SCS System implantable and surgical components are sterilized with
ethylene oxide.
Inspect the condition of the sterile package before opening the package and using the contents.
Do not use the contents if the package is broken or torn, or if contamination is suspected
because of a defective sterile package seal.
• Do not use any component that shows signs of damage.
• Do not resterilize the package or the contents. Obtain a sterile package from Boston
Scientific.
• Do not use if the product is past the labeled expiration date.
• All components are for single use only. Do not reuse.
• Do not use if package is opened or damaged.
• Do not use if labeling is incomplete or illegible.
WARNING: Contents supplied STERILE using an ethylene oxide (EO) process. Do not use
if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
For Single Use Only.
Do Not Reuse.
Do Not Resterilize.
Do not use if package is damaged.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or
resterilization may also create a risk of contamination of the device and/or cause patient
infection or crossinfection, including, but not limited to, the transmission of infectious disease(s)
from one patient to another. Contamination of the device may lead to injury, illness or death of
the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or
local government policy.

Technical Service

There are no user serviceable parts. If you have a specific question or issue, please contact
your Boston Scientific representative.
Spectra Wavewriter™ System Information for Prescribers
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