Boston Scientific Precision - Sterilization, Handling, and Storage; Sterilization; IPG Handling and Storage

Sterilization, Handling, and Storage
Clinician Manual
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Sterilization, Handling, and Storage
Sterilization
All Precision 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 Scientic.
• Do not use the product if the labeled “Use By” date has passed.
• 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 Scientic 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 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.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local
government policy.
IPG 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 from a height of more than one foot.
• Do not incinerate an IPG. Improper disposal of the device could result in an explosion. Devices should
be explanted in the case of cremation, and returned to Boston Scientic Neuromodulation. An explant
kit is available.
Store the IPG between 0 °C and 45 °C (32 °F and 113 °F). Devices should always be kept in temperature
regulated areas within the acceptable temperature range. IPG damage can occur at temperatures outside of
this range.