Depuy Synthes EXPEDIUM VERSE Bedienungsanleitung Seite 10

• If areas are difficult to inspect visually, check for blood by
immersing or flushing the instrument in a 3% hydrogen
peroxide solution. If bubbling is observed, blood is present.
Rinse instruments for a minimum of 1 minute with warm,
85°F – 104°F (30°C - 40°C), tap water after using
hydrogen peroxide solution.
• If soil is still present, re-clean the instrument.
Disinfection
Devices must be terminally sterilized prior to surgical use.
See Sterilization instructions.
Maintenance
Carefully inspect instruments between uses to verify proper
functioning. Send damaged instruments to a supplier of
authorized repair or refurbishment services.
Inspection and Functional Testing
• Visually inspect the instruments for damage and wear.
• The shafts should be free of bending and distortion.
• Cutting edges of the Drills should be free of nicks and have
a continuous edge.
• Moveable parts should have smooth movement without
excessive play.
• Locking mechanisms should fasten securely and close easily.
Packaging
• If desired, use instrument trays to contain instruments that
are provided in sets.
• Double wrap instruments in accordance with local
procedures, using standard wrapping techniques such as
those described in the current revision of ANSI/AAMI ST79.
Sterilization
• Use a validated, properly maintained and calibrated
steam sterilizer.
• Effective steam sterilization can be achieved using the
following cycle:
Cycle Type Temperature
Pre-Vacuum 270°F (132°C) 4 minutes
Pre-Vacuum 273°F (134°C) 3 minutes
• Post-sterilization drying of the sterilization load within the
sterilization vessel is standard practice in hospitals. ANSI/
AAMI ST79:2006, "Comprehensive guide to steam steriliza-
tion 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.
• Only legally marketed, FDA cleared sterilization wrap,
pouches, or DePuy Synthes Reusable Sterilization
Containers should be used by the end-user for packaging
Exposure
Time Dry Time
60 minutes
60 minutes
10 of 196
terminally sterilized devices. The manufacturer's instruc-
tions for use for the sterilization wrap, pouches, or DePuy
Synthes Reusable Sterilization Containers are to be fol-
lowed. The use of DePuy Synthes Reusable Sterilization
Containers are limited to use in the United States only, and
are not approved for use outside of the United States.
Storage
Store sterile packaged devices in a manner that provides
protection from dust, moisture, insects, vermin, and extremes
of temperature and humidity.
MAGNETIC RESONANCE (MR)
COMPATIBILITY
The EXPEDIUM VERSE Spine 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 spi-
nal 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 L5-S1 vertebra, degenerative spondylolisthesis
with objective evidence of neurologic impairment, fracture,
dislocation, scoliosis, kyphosis, spinal tumor, and failed previ-
ous fusion (pseudarthrosis). The safety and effectiveness of
these devices for any other conditions are unknown.
CoCr tapered rods are not intended to connect the
EXPEDIUM Spine System to the Synthes SYNAPSE System.
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 bear-
ing 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 unless otherwise
specified.