Johnson & Johnson DePuy Spine EXPEDIUM SFX, Руководство пользователя

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• Enzyme soak
•
Rinse
• Ultrasonic cleaning (10­20 minutes)
•
Rinse
• Automated cleaning in a washer disinfector with lid on to
contain implant components
• Dry
Avoid impact, scratching, bending or surface contact
with any materials that might affect the implant surface
or configuration.
Special attention shall be paid to recesses since both
chemicals and rinse water may be entrapped in them.
RECOMMENDATIONS FOR
STEAM STERILIZATION:
Wrap implants in accordance with local procedures using
standard wrapping techniques such as those described in
ANSI/AAMI ST79:2006.
In a properly functioning calibrated steam sterilizer,
independent testing has shown that effective sterilization
may be achieved using the following parameters:
Cycle: Pre­Vacuum
Temperature: 270° F (132° C)
Exposure time: 4 minutes
Drying Time:
60 minutes
Post­sterilization drying of the sterilization load within
the sterilization vessel is standard practice in hospitals.
ANSI/AAMI ST79:2006, “Comprehensive guide to steam
sterilization and sterility assurance in health care facilities”
provides guidance to hospitals for selecting appropriate
drying parameters based on the sterilization cycle that is
being conducted. Sterilizer manufacturers also typically
provide recommendations for drying parameters for their
specific equipment.
Implants previously implanted must
not be re­used.
MAGNETIC RESONANCE (MR)
COMPATIBILITY
The EXPEDIUM SFX Cross Connector System has not
been evaluated for safety and compatibility in the MR
environment. They have not been tested for heating or
migration in the MR environment.
USAGE
WARNING: The safety and effectiveness of pedicle screw
spinal systems have been established only for spinal
conditions with significant mechanical instability or deformity
requiring fusion with instrumentation. These conditions
are significant mechanical instability or deformity of the
thoracic, lumbar, and sacral spine secondary to severe
spondylolisthesis (grades 3 and 4) of the L5­S1 vertebra,
degenerative spondylolisthesis with objective evidence of
neurological impairment, fracture, dislocation, scoliosis,
kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis). The safety and effectiveness of these
devices for any other conditions are unknown.
PRECAUTION: The implantation of pedicle screw spinal
systems should be performed only by experienced spinal
surgeons with specific training in the use of this pedicle
screw spinal system because this is a technically demanding
procedure presenting a risk of serious injury to the patient.
The surgeon must be thoroughly knowledgeable not only
in the medical and surgical aspects of the implant, but
must also be aware of the mechanical and metallurgical
limitations of metallic surgical implants. Postoperative care
is extremely important. The patient must be instructed
in the limitations of the metallic implant and be warned
regarding weight bearing and body stresses on the
appliance prior to firm bone healing. The patient should be
warned that noncompliance with postoperative instructions
could lead to failure of the implant and possible need
thereafter for additional surgery to remove the device.
Refer to the individual system surgical technique manuals
for additional important information.
DePuy Spine Spinal System components should not be
used with components from other manufacturers.
After solid fusion occurs, these devices serve no functional
purpose and may be removed. In some cases, removal is
indicated because the implants are not intended to transfer
or to support forces developed during normal activities.
Any decision to remove the device must be made by the
physician and the patient taking into consideration the
patient’s general medical condition and the potential risk to
the patient of a second surgical procedure.
These devices are not intended or expected to be the only
mechanism for support of the spine. Regardless of the
etiology of the spinal pathology, for which implantation
of these devices was chosen, it is the expectation and
requirement that a spinal fusion or arthrodesis be planned
and obtained. Without solid biological support provided by
spinal fusion, the devices cannot be expected to support
the spine indefinitely and will fail in any of several modes.
These modes may include bone­metal interface failure,
implant fracture, or bone failure.
When using posterior spinal instrumentation in children,
it is preferable that children be above the age of ten but
need not have reached skeletal maturity. In special circum­
stances, implants may be used at younger ages. Due to the
difficulties in conducting randomized prospective studies
with children, there is limited clinical data on pediatric