Warnings; Precautions - Boston Scientific SureTek Burr Hole Cover Instrucciones De Uso

Burr Hole Cover Directions for Use

Warnings

Prior to securing the base, examine the cranial bone and structure to ensure that disease or damage are
not present and that the thickness of the bone is 5 mm or greater. Failure to adhere to this warning may
negatively impact the following:
• Lead Anchoring. Lead migration due to an improperly anchored lead may diminish the
effectiveness of therapy.
• Burr Hole Closure. An unstable closure may increase the risk of infection and place the patient at
risk for damage to neural brain tissue, CSF leakage and/or damage to the dura.

Precautions

Components. The use of components other than those supplied by Boston Scientific and intended for use
with the Boston Scientific DBS System may damage the system, diminish the effectiveness of therapy,
and/or put the patient at unknown risk. A backup device should be available at the time of surgery.
Sterilization. Contents of the surgical kits are supplied sterile using an ethylene oxide process. Do not
use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative and return
the damaged part to Boston Scientific.
Resterilization. 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 cross-infection, 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. If resterilization is desired, obtain a new sterile device for
implantation.
Check the expiration date on the package before opening the sterile package and using the contents. Do
not use the contents if the current date is past the "Use By" date, if the package is opened or damaged, or if
contamination is suspected because of a defective sterile package seal.
• Inspect the seal integrity of the outer tray before use.
• Inspect the seal integrity and sterile indicator on the inner tray. The sterile indicator will be green
with red stripes if sterile. Yellow stripes indicate the tray is not sterile. If the tray is not sterile, do
not use the components and return to Boston Scientific.
• Open the inner tray in the sterile field.
• Do not use any component that shows signs of damage.
• Do not use if "Use By" date has expired.
Storage, Handling and Transport. Store components between 0° C to 45° C (32° F to 113° F) in an area
where they are not exposed to liquids or excessive moisture. Temperatures outside of the stated range
can cause damage. If stored in conditions beyond the required storage temperature, do not use the
components and return to Boston Scientific.
Component Removal and Disposal. Dispose of the Burr Hole Cover kit components and packaging in
accordance with hospital, administrative and/or local government policy.
Burr Hole Cover Directions for Use
91062297-02 2 of 251