Product Info
Information for Prescribers
WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers
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Sterilization
All implantable and surgical components of the WaveWriter Alpha and WaveWriter Alpha Prime Systems,
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 Scientic.
• 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 Scientic representative.
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.