Additional Information - Depuy Synthes EXPEDIUM SFX Handbuch

Step 8. Sterilization
Steam (moist heat) sterilization shall be performed in a locally
approved, pre-vacuum (forced air removal) cycle. The steam
sterilizer should be validated to the requirements of any local
standards and guidance such as EN 285 or AAMI/ANSI ST8.
The steam sterilizer should be installed and maintained in
compliance to manufacturer's instructions and local require-
ments. Ensure that the steam sterilizer cycle is chosen that is
designed to remove air from porous or lumened device loads
in accordance to manufacturer's instructions and does not
exceed the criteria for sterilizer load.
The following steam sterilization cycles are examples of
validated cycles:
Minimum
Sterilization
Condition- Exposure Time
ing Phase (minutes)
Prevacuum 4
Prevacuum 3
Extended steam exposure cycle can be used to meet local
requirements such as 134°C (274°F) for 18 minutes.
The efficiency of steam sterilizer drying can range considerable
depending on the sterilizer design, loading, packaging and
steam supply during the sterilization process. The user
should employ verifiable methods (e.g. visual inspections)
to confirm adequate drying. Extended drying within the
sterilizer or in an external drying cabinet in accordance with
manufacturer's instructions may be necessary. Do not exceed
140°C (284°F) during drying.
Immediate-Use steam sterilization is only intended for individual
instruments and should only be performed when approved by
local policies. DePuy Synthes does not support immediate-
use steam sterilization of instrument sets, cases or implants
using this method.
The following steam sterilization cycle is an example of a
validated cycle for individual instruments only:
• Unwrapped instrument
• A minimum 3 (three) pulse prevacuum cycle
• 132°C (270°F) for 4 minutes
Step 9: Storage
Sterilized products should be stored in a dry, clean
environment, protected from direct sunlight, pests, and
extremes of temperature and humidity.
Refer to sterilization wrap or rigid container manufacturers
IFU for limits on sterile product storage time and storage
requirements for temperature and humidity.
Minimum
Sterilization
Exposure
Temperature Dry Time*
132°C
30 minutes
(270°F)
134°C
30 minutes
(274°F)
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ADDITIONAL INFORMATION

Cleaning agent information: Examples of detergents that have
been used during cleaning validations include Prolystica™ 2X
Concentrate Enzymatic Cleaner, Prolystica™ 2X Neutral
Detergent, Enzol™, Endozime™, Neodisher Medizym™,
Terg-A-Zyme™, and NpH-Klenz™.
The chemical quality of the water used during reprocessing
can impact device safety. Facilities should use the
recommended water quality requirements for device
reprocessing in accordance with local guidance (such as
AAMI TIR 34, Water for the reprocessing of medical devices)
and these instructions for use.
These instructions for use have been validated in accordance
with ISO 17664. It remains the responsibility of the facility to
ensure that the processing is performed using equipment,
materials and personnel at a designated area, and achieves
the desired requirements. This includes validation and routine
monitoring of the process. Likewise, any deviation by the
processor from these recommendations should be evaluated
for effectiveness and any potential adverse consequences.
All personnel using these instructions should be qualified
with documented expertise, competency and training. Users
should be trained on healthcare facility policies and proce-
dures along with current applicable guidelines and standards.
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 L5-S1 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.