Orthofix Firebird Wirbelsäulen-Fixationssystem Gebrauchsanleitung Seite 4

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 minutes 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 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 System HA coated screw implants are sterilized using gamma radiation sterilization. Do not
re-sterilize. All other implants and instruments are supplied NON-STERILE.
For Firebird Spinal Fixation System Cases 44-9010, 44-9011, 44-9012, 44-9013, 44-
9020, 44-9030, 44-9040, 44-9050 and 61-9060:
The Firebird Spinal Fixation System should be sterilized by the hospital using one of the
following recommended cycles when utilizing an FDA cleared sterilization wrap:
Method: Steam
Cycle: Gravity
Temperature: 250°F (121°C)
Exposure time: 30 minutes
For All Other Firebird Systems Cases and Caddies:
Prior to use, all implants and instruments should be placed in the appropriate Orthofix case
which will be wrapped in an FDA cleared sterilization wrap, or individually wrapped, and placed
in the autoclave for sterilization by the hospital using one of the following recommended cycles:
Method: Steam
Cycle: Gravity
Temperature: 270°F (132°C)
Exposure time: 15 minutes
Drying time: 30 minutes
Double wrapped
AW-36-9902 Rev. AF
FB-2103 © Orthofix, Inc. 05/2021
or: Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Exposure time: 8 minutes
or: Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Preconditioning: Per
manufacturer's settings
Exposure time: 4 minutes
Drying time: 30 minutes
Double wrapped
Firebird NXG, JANUS Midline Fixation Screw and JANUS Fenestrated Screw System
Sterilization in Rigid Sterilization Containers:
When using rigid sterilization containers, clean, inspect and prepare the rigid sterilization
container according to the manufacturer's instructions.
Select the appropriate rigid sterilization container with either filtered bottom or solid bottom to
properly enclose the Orthofix case(s) (recommended 23¼" long x 11¼" wide container). The
following sterilization cycle has been validated:
Sterilization Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Preconditioning: Per manufacturer's settings
Exposure time: 4 minutes
Drying time: 30 minutes
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 successfully 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 System instruments and implants are provided in a modular case specifically intended to
contain and organize the system components. The system instruments are organized into trays
within the modular case for easy retrieval during surgery. These trays also provide protection to
the system components during shipping. Additionally, individual instruments and implants will
be provided in sealed poly bags with individual product labels attached to them.
Note: The HA coated screws are provided sterile. Do not use if the package is opened or
damaged, or if the expiration date has passed.
Product Complaints:
Any Health Care 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:
Recommended operative techniques for the use of these systems are available upon request
from Orthofix at the phone numbers provided above.
Latex Information:
The implants, instruments and/or packaging material for the 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.
All third party trademarks used herein are the trademarks of their respective owners. KYPHON®
HV-R is a registered trademark of Medtronic, Inc. Orthofix is not associated with or sponsored by
Medtronic, Inc.
Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
4
Federal (U.S.A.) law restricts this device to sale
by or on the order of a physician
See Instructions for Use
Use By Date
Orthofix.com/IFU
Manufacturer
Single Use Only Authorized
Representative
Do Not Reuse
Catalogue Number
Do Not Resterilize
Provided Non-Sterile
Serial Number
Sterilized Using
Lot Number
Irradiation