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12, Design, testing, and labeling reusable medical devices
for reprocessing in health care facilities: A guide for device
manufacturers.
NON-STERILE IMPLANTS
For the implants supplied non-sterile, they will be supplied
clean. ISO 8828 or AORN recommended practices for in-
hospital sterilization should be followed for all components.
RECOMMENDATIONS FOR
STEAM STERILIZATION
In a properly functioning calibrated steam sterilizer, inde-
pendent testing has shown that effective sterilization may be
achieved using the following parameters:
Cycle: Pre-Vacuum
Temperature: 270° F (132° C)
Exposure Time:
4 minutes
Drying Time:
60 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
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.
Only legally marketed, FDA cleared sterilization wrap,
pouches, or DePuy Synthes Reusable Sterilization
Containers should be used by the end-user for packaging
terminally sterilized devices. The manufacturer's instructions
for use for the sterilization wrap, pouches, or DePuy Synthes
Reusable Sterilization Containers are to be followed. 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.
Inspect visually for damage or the presence of blood or tis-
sue. If blood or tissue is observed on the implant, it must be
thoroughly cleaned manually using a soft brush and neutral
pH detergent or discarded.
Cleaning instructions
•
Enzyme soak
•
Rinse
•
Ultrasonic cleaning (10-20 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.
Wrap implants in accordance with local procedures using
standard wrapping techniques such as those described in
ANSI / AAMI ST79:2006.
Implants previously implanted should not be re-used.
INDICATIONS AND USAGE
CAUTION: U.S.A. Law restricts this device to sale by or on
the order of a physician.
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.
The SUMMIT SI OCT Spinal System and MOUNTAINEER
OCT Spinal System are intended to promote fusion of
the cervical spine and occipito-cervico-thoracic junction
(occiput-T3), and are indicated for the following:
•
ddd (neck pain of discogenic origin with degeneration of
the disc as confirmed by patient history and radiographic
studies)
•
spondylolisthesis
•
spinal stenosis
•
fracture/dislocation
•
atlanto/axial fracture with instability
•
occipitocervical dislocation
•
revision of previous cervical spine surgery
•
tumors
The occipital bone screws are limited to occipital fixa-
tion only.
The use of the monoaxial and polyaxial screws is limited to
placement in the upper thoracic spine (T1-T3) in treating
thoracic conditions only. They are not intended to be placed
in the cervical spine.
The SONGER wire/cable system to be used with the
SUMMIT SI OCT Spinal System and MOUNTAINEER OCT
Spinal System allows for wire/cable attachment to the
posterior cervical spine.
