Orthofix Unity Mode D'emploi page 3

Preparation for Cleaning:
1. All instruments with moving parts (e.g., knobs, triggers, hinges) should be placed in the
open position to allow access of the cleaning fluid to areas that are difficult to clean.
2. Soak the instruments for a minimum of 10 minutes in purified water prior to the manual or
automated cleaning process.
3. Use a soft cloth or a soft plastic bristle brush to remove any visible soil from the instruments
prior to manual or automated cleaning. Use a soft plastic bristle brush or a pipe cleaner to
remove soil from any inner lumens. You can also use a syringe (if appropriate) for hard to
reach areas.
4. Enzymatic detergent should be used for manual and automated cleaning. All enzymatic
detergents should be prepared at the use dilution and temperature recommended by the
manufacturer. Softened tap water may be used to prepare the enzymatic detergents. Use of
recommended temperatures is important for optimal performance of enzymatic detergent.
Manual Cleaning:
1. Completely submerge instruments in an enzymatic detergent and allow to soak for 20
minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has
been removed. Particular attention must be given to crevices, lumens, mated surfaces,
connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow,
soft-bristled brush (i.e. pipe cleaner brush).
2. Remove the instruments from the enzymatic detergent and rinse in tap water for a minimum
of 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficult to reach
areas.
3. Place prepared cleaning solution in a sonication unit. Completely submerge device in
cleaning solution and sonicate for 10 minutes.
4. Rinse instrument in purified water for at least 3 minutes or until there is no sign of blood or
soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens, holes
and other difficult to reach areas.
5. Repeat the sonication and rinse steps above.
6. Remove excess moisture from the instrument with a clean, absorbent and non-shedding
wipe.
7. Inspect the instruments for visible soil.
8. If visible soil is noted, repeat the steps listed above.
Automated Cleaning:
1. Completely submerge the instruments in an enzymatic detergent and allow to soak and
sonicate for 10 minutes each. Use a soft nylon bristled brush to gently scrub the device until
all visible soil has been removed. Particular attention must be given to crevices, lumens,
mated surfaces, connectors and other hard to clean areas. Lumens should be cleaned with
a long, narrow, soft nylon bristled brush (i.e. pipe cleaner). Use of a syringe or water jet will
improve flushing of difficult to reach areas and closely mated surfaces.
2. Remove instruments from the cleaning solution and rinse in purified water for a minimum of
1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult to reach
areas.
3. Place instruments in a suitable washer/disinfector basket and process through a standard
instrument washer/disinfector cleaning cycle.
4. Orient instruments into the automated washer's carriers as recommended by the washer
manufacturer.
5. The following minimum parameters are essential for thorough cleaning.
a. 2 minute prewash with cold tap water
b. 1 minute prewash with hot tap water
c. 2 minute detergent wash with hot tap water (64-66°C/146-150°F)
d. 1 minute hot tap water rinse
e. 2 minute thermal rinse with purified water (80-93°C/176-200°F)
f. 1 minute purified water rinse (64-66°C/146-150°F)
g. 7 to 30 minute hot air dry (116°C/240°F)
6. Inspect the instruments for visible soil.
7. If visible soil is noted, repeat the above listed steps until no visible soil is noted.
Note: Certain cleaning solutions such as those containing caustic soda, formalin, glutaraldehyde,
bleach, and/or other alkaline cleaners may damage instruments. These solutions should not be
used.
Note: Visually inspect instruments after cleaning and prior to each use. Discard or return to Orthofix
any instruments that are broken, discolored, corroded, have cracked components, pits, gouges, or
are otherwise found defective. Do not use defective instruments.
Instrument Use:
• Never use torque limiting drivers in the counter-clockwise (CCW) direction to loosen
a fastener
• Only use torque limiting handle as intended per the operative technique
• Never impact on torque limiting handles or use as an impacting device on other devices
• Never use a torque limiting handle as a prying tool
Torque Limiting Instrument Maintenance:
• If a torque-limiting handle has been dropped, impacted or used incorrectly, return to
Orthofix.
• Torque-limiting handles require maintenance at minimum, every three years or per your
service agreement. Please return your torque limiting handles to Orthofix for required
maintenance.
Instrument End of Life Determination:
Do not reuse Single Use instruments. Visually inspect the reusable instruments to determine if the
instrument has reached end of life. Orthofix reusable instruments have reached End of Life when:
1. Instruments show signs of damage such as binding, bending, breakage, overt signs of wear
and/or any other conditions which may impact the devices safe and effective use.
2. Instruments intended for cutting bone and/or tissue (e.g. tap, rasp, curette, rongeur) – when
any of the cutting surfaces show signs of wear such as nicks, abrasions or otherwise dulled
cutting surfaces.
3. Instruments that interface with other devices (e.g. implants, instruments, handles) - when
the mating feature binds, fails to attach or fails to hold the device securely. The instrument
function should be verified prior to each use.
4. Do not use instruments which reached End of Life. Discard End of Life instruments per your
hospital procedure or return to Orthofix for disposal.
Sterilization:
The Unity Lumbosacral Fixation System should be sterilized by the hospital using the recommended
cycle:
Method: Steam
Cycle: Gravity
Temperature: 250°F (121°C
Exposure time: 30 minutes
Physician Information:
Patient Selection:
Patient selection is an extremely important factor in the success of implant procedures. It is
important that the candidates be carefully screened and the optimal therapy selected.
Preoperative:
1. Carefully screen the patient, choosing only those that fit the indications described above.
2. Care should be exercised in the handling and storage of the implant components. The
implants should not be scratched or otherwise damaged. Store away from corrosive
environments.
3. An adequate inventory of implants should be available at surgery of the sizes expected to
be used.
4. All components and instruments should be cleaned and sterilized prior to each use.
Additional sterile components should be available in case of an unexpected need.
Intraoperative:
1. Instructions should be carefully followed.
2. Extreme caution should be used around the spinal cord and nerve roots.
3. The implant surface should not be scratched or notched since such actions may reduce the
functional strength of the construct.
4. Bone grafts must be placed in the area to be fused such that the graft fits snugly against the
upper and lower vertebral bodies.
5. Bone cement should not be used as it will make removal of the components difficult or
impossible.
6. Before closing soft tissue, check each screw to make sure that none have loosened.
Postoperative:
1. Detailed instructions should be given to the patient regarding care and limitations, if any.
2. To achieve maximum results, the patient should not be exposed to excessive mechanical
vibrations. The patient should not smoke or consume alcohol during the healing process.
3. The patient should be advised of their limitations and taught to compensate for this
permanent physical restriction in body motion.
4. If a non-union develops or if the components loosen, the devices should be revised or
removed before serious injury occurs. Failure to immobilize the non-union, or a delay in
such, will result in excessive and repeated stresses on the implant. It is important that
immobilization of the spinal segment be maintained until fusion has occurred.
5. The implants are temporary internal fixation devices. Internal fixation devices are designed
to stabilize the spine during the normal healing process. After the spine is fused, the devices
serve no functional purpose and should be removed.
Patient Information:
The temporary internal fixation devices used in your recent spinal surgery are metallic implants
that attach to the bone and aid in the healing of bone grafts. These implants have been shown
to be valuable aids to surgeons in the treatment of bony fusions. These devices do not have the
capabilities of living bone. Intact living bone is self-repairing, flexible and occasionally breaks and/or
degrades. The anatomy of the human body places a size limitation on any artificial fixation device
used in surgery. The maximum size limitation increases the chances of the mechanical complications
of loosening, bending, or breaking of the devices. Any of these complications could result in the
need for additional surgery. Accordingly, it is very important that you follow the recommendations
of your physician. Use braces as instructed. By following these instructions, you can increase your
chances of a successful result and reduce your risk of injury and/or additional surgery.
Packaging:
Packages for each of the components should be intact upon receipt. If a consignment system is
used, all sets should be carefully checked for completeness and all components should be carefully
checked for damage prior to use. Damaged packages or products should not be used and should be
returned to Orthofix.
The Unity Lumbosacral Fixation System instruments and implants are provided in modular cases
specifically intended to contain and organize the system's components. The system's instruments
are organized into trays within each modular case for easy retrieval during surgery. These trays also
provide protection to the system components during shipping. Additionally, individual instruments
and implants are provided in sealed poly bags with individual product labels.
Product Complaints:
Any Healthcare Professional (e.g., customer or user of this system of products) who has any
complaints or who has experienced any dissatisfaction in the product quality, identity, durability,
reliability, safety, effectiveness and/or performance, should notify Orthofix Inc., 3451 Plano Parkway,
Lewisville, TX 75056, USA, by telephone at 1-214-937-3199 or 1-888-298-5700 or by e-mail at
complaints@orthofix.com.
Further Information:
A recommended operative technique for the use of this system is available upon request from
Orthofix at the phone numbers provided above.
Latex Information:
The implants, instruments and/or packaging material for the Unity Lumbosacral Fixation System are
not formulated with and do not contain natural rubber. The term "natural rubber" includes natural
rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber
in its formulation.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
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or: Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Exposure time: 8 minutes