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Safety Information
Sterilization
All implantable and surgical components are sterilized with ethylene oxide (EO) and are for single use
only.
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 the package is opened or damaged.
• Do not use if the labeling is incomplete or illegible.
WARNING: Contents are supplied sterile using an EO process. Do not use if the sterile barrier is
damaged. If damage is found, contact your Boston Scientific 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 result in 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 cross infection, including, but not limited to,
the transmission of infectious disease(s) from one patient to another. Contamination of the device may
result in injury, illness or death of the patient.
Products used during surgery and explanted components are biohazards. After use, dispose of product
and packaging in accordance with hospital, administrative and/or local government policy. For more
information, see "Device Disposal" on page 17.
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.
Use the following instructions to avoid damage to the Pairing Magnet and Pairing Magnet case:
• Clean the Pairing Magnet with the following cleaning agents only: warm tap water, Isopropyl
alcohol (70% concentration), or a weak concentration of mild detergent mixed with warm water.
Apply cleaning agents to a soft cloth and use gentle pressure. Do not submerge the Pairing Magnet
or place under running water.
• If you lose the Pairing Magnet or if the plastic coating surrounding the Pairing Magnet cracks,
contact Boston Scientific for a replacement.
There are no other special handling or storage requirements.
Technical Service
There are no user serviceable parts. If you have a specific question or issue, contact your Boston
Scientific representative.
Safety Information
Implantable Pulse Generator
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