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Sterilization: Contents of the surgical kits are supplied sterile using an ethylene oxide (EO)
process. Do not use if sterile barrier is damaged. If damage is found, call Boston Scientific
Technical Support and return the damaged part to Boston Scientific.
All implantable and surgical components are sterilized with 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.
Stimulator Orientation: Orient the Stimulator parallel to the skin surface. Suboptimal
placement of the Stimulator may result in a revision surgery. Patients should avoid touching
the Stimulator site or incisions. If patients notice a change in the appearance of the skin at the
Stimulator location, such as the skin becoming thin over time, they should contact their healthcare
provider.
In order to ensure effective device communications, including device programming, and proper
charging, perform the following:
•
For rechargeable IPGs, orient the Stimulator parallel to the skin surface and at a depth
less than 2 cm and greater than 0.5 cm below the skin.
•
For non‑rechargeable Vercise Genus IPGs, orient the Stimulator parallel to the skin
surface and at a depth less than 2.5 cm below the skin to ensure effective device
communication.
•
For the non‑rechargeable Vercise PC IPG (DB‑1140), orient the Stimulator parallel to the
skin surface. There is no depth restriction for the Vercise PC IPG.
•
The etched writing "This Side Up" must be facing out of the pocket toward the patient's
skin.
Suboptimal placement of the Stimulator may result in the inability to communicate with the device
or inability to recharge and may require a revision surgery.
Patients should be instructed not to change the orientation of or turn over the Stimulator. If the
Stimulator flips over in the body, then it cannot communicate or be charged. If stimulation cannot
be turned on after charging, the Stimulator may have changed orientation or rotated; patients
should contact their healthcare provider to arrange an evaluation of the system.
Safety Information
Information for Prescribers
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