Orthofix Hallmark Gebrauchsanleitung Seite 3

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.
Torque Limiting Instrument Maintenance
• Only use torque limiting handles as intended. Never use torque limiting handles in the
counterclockwise (CCW) direction to break loose a set screw or any other implant.
• 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.
• If a torque-limiting handle has been dropped, impacted or used incorrectly, recalibration
should be performed.
• 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 Hallmark Anterior Cervical Plate System should be sterilized by the hospital using the
recommended cycle:
Method: Steam (wrapped) or:
Cycle: Gravity
Temperature: 250°F (121°C)
Exposure time: 30 minutes
Drying 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.
AW-62-9903 Rev.AF
HM-2101 © Orthofix, Inc. 05/2021
Method: Steam (wrapped)
Cycle: Prevac
Temperature: 270°F (132°C)
Exposure time: 8 minutes
Drying time: 30 minutes
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 Hallmark Anterior Cervical Plate 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) who has any complaints or
who has experienced any dissatisfaction with 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 email 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 Hallmark Anterior Cervical Plate
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.
CAPA Symbols Chart revised2 - HALLMARK - EN
3
Federal (U.S.A.) law restricts this device to sale
by or on the order of a physician
See Instructions for Use
Manufacturer
Authorized
Orthofix.com/IFU
Representative
Single Use Only
Serial Number
Do Not Reuse
Lot Number
Catalogue Number
Provided Non-Sterile