Sterilization, Handling, And Storage; Sterilization; Ipg Handling And Storage - Boston Scientific Precision Manuel

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 Scientific.
• 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 Scien-
tific representative.
For Single
Do Not Reuse.
Do Not Resterilize.
Do not use if package is damaged.

Sterilization, Handling, and Storage

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
• Keep sharp instruments away from the
• Do not use the IPG if it has been dropped
• Do not incinerate an IPG. Improper
Store the IPG between 0 °C and 45 °C
(32 °F and 113 °F). Devices should always
Use Only.
be kept in temperature regulated areas within
the acceptable temperature range. IPG
damage can occur at temperatures outside of
this range.
care.
components.
on a hard surface from a height of more
than one foot.
disposal of the device could result in an
explosion. Devices should be explanted
in the case of cremation, and returned to
Boston Scientific Neuromodulation. An
explant kit is available.
90607862-22 Rev A
Clinician Manual
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