Sterilization, Handling, And Storage; Sterilization; Ipg Handling And Storage - Boston Scientific Precision SC-1110 Serie Manual De Uso

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
Scientific representative.
For Single Use Only.
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 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 Scientific
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.
9055959-008 Rev A 15 of 327
Clinician Manual