Idiomas disponibles
Idiomas disponibles
13. Excessive torque applied to the screws may strip the threads in the bone.
14. DO NOT REUSE IMPLANTS. Discard used, damaged, or otherwise suspect implants.
15. 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.
16. Based on fatigue testing results, the physician/surgeon should consider the levels of
implantation, patient weight, patient activity level, other patient conditions, etc. which
may impact the performance of the system.
17. Mixing of dissimilar metals can accelerate the corrosion process. Do not use the titanium
alloy or cobalt chrome alloy components of this system with implants of other material
composition or components from different manufacturers unless specifically stated.
18. The Firebird Spinal Fixation System and Phoenix MIS Fixation System have not been
evaluated for safety and compatibility in the MR environment, nor have the Firebird Spinal
Fixation System or the Phoenix MIS Fixation System been tested for heating or migration
in the MR environment.
19. Reuse of the devices labeled as single-use could result in injury or re-operation due to
breakage or infection. Do not attempt to re-sterilize single-use implants that come in
contact with body fluids.
20. When using the offset connectors to connect the Firebird spinal construct to the ilium,
pedicle screws must be used at the S1 or S2 level of the spine. Do not use the offset
connectors to connect the ilium without this intermediate screw fixation.
21. The safety, efficacy and performance of the system have been established for conditions
in which the system is used as intended and when used as identified in the Indications
for Use. Performance of the system has not been evaluated for use that is contrary to
the Intended Use, Indications for Use or for use that is contraindicated. Failure to use the
system as indicated could detrimentally affect the performance of its components.
22. Other adverse effects related to pedicle screw fixation, such as screw or rod bending,
breakage, or loosening, may also occur in pediatric patients. Pediatric patients may be at
increased risk for device-related injury because of their small stature.
23. The correct handling of the implant is extremely important. Implants should not be
excessively or repeatedly bent, notched or scratched. These operations can produce
defects in surface finish and internal stress concentrations, which may become the focal
point for eventual failure of the device.
MRI Compatibility Information:
The Firebird Spinal Fixation System/Phoenix MIS Fixation System has not been evaluated for
safety and compatibility in the MR environment. It has not been tested for heating, migration, or
image artifact in the MR environment. The safety of the Firebird Spinal Fixation System/Phoenix
MIS Spinal Fixation System in the MR environment is unknown. Scanning a patient who has this
device may result in patient injury.
Cleaning:
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System HA Coated Screw
implants are sterilized using gamma radiation sterilization. Do not re-sterilize. All other system
implants are provided clean but not sterile. Once an implant comes in contact with any human
tissue or bodily fluid it should not be re-sterilized or used. Please discard all contaminated
implants.
For Firebird Spinal Fixation System Cases 44-9011, 44-9012, 44-9013, 44-9020,
44-9030, 44-9040, 44-9050 and 61-9060:
All instruments and implants must first be cleaned using established hospital methods before
sterilization and introduction into a sterile field. Additionally, all instruments and implants that
have been previously taken into a sterile surgical field must first be cleaned using established
hospital methods before sterilization and reintroduction into a sterile surgical field. Cleaning
can include the use of neutral cleaners followed by a deionized water rinse. All products should
be treated with care. Improper use or handling may lead to damage and possible improper
functioning of the device.
For All Other Firebird, Phoenix and JANUS Cases and Caddies:
All instruments must be thoroughly cleaned after each use using the manual or automated
cleaning method listed below.
From Point of Use:
Whenever possible, do not allow blood, debris or body fluids to dry on instruments. For best
results and to prolong the life of the surgical instrument, reprocess immediately after use.
Cleaning may be done using validated hospital methods or following the validated cleaning
process described below.
Instructions for Disassembly and Assembly:
Prior to cleaning please see the operative technique for disassembly and assembly instructions
for the five instruments which require disassembly prior to cleaning, the: Multi-Axial Screw Driver
(20-0200), Mono-Axial Screw Driver (20-0300), Multi-Axial Screw Driver (36-1831), Modular
Screw Driver (36-1832) and the Midline Modular Screw Driver (36-1833). No other instruments
within the system require disassembly prior to cleaning.
Preparation for Cleaning:
1. Any instruments with moving parts (i.e., knobs, triggers, hinges) should be separated and
placed in the open position to allow better access of the cleaning fluid to the difficult to
clean areas. Use a soft cloth or plastic bristle brush to remove any visible soil from the
instruments.
2. Soak the instruments for a minimum of 10 minutes in sterile 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.
Manual Cleaning:
1. After disassembly of the instruments, use a soft cloth and/or a soft plastic bristle brush to
remove any visible soil from the outside and inside of the instrument.
2. Prepare Vesphene
IIse agent at the use-dilution recommended on the label directions
®
(1 ounce per gallon) as follows: Add 1 mL of Vesphene
water per the manufacturer's recommendations.
3. Bathe instruments in prepared room temperature solution as recommended by the
detergent manufacturer.
4. Manually agitate instruments in Vesphene
5. Scrub instruments with a soft plastic bristle brush if visible soil is noted and use a soft
plastic bristle brush or pipe cleaner long enough to reach the entire length of the interior
lumen to remove the soil.
6. Rinse the instruments in USP <1231> purified water for 1.5 minutes.
7. Hang dry the device.
8. Visually inspect the instruments for visible soil.
9. If visible soil is noted, repeat the steps listed above.
Automated Cleaning:
1. After disassembly of the instruments use a soft cloth or soft plastic bristle brush to
remove any visible soil from the outside of and inside of the instruments. Use a soft
plastic bristle brush or pipe cleaner long enough to reach the entire length of the interior
lumen to remove the soil from the inner lumens prior to automated cleaning.
2. Set up the washer/disinfector detergent dose at ½ ounce of Endozime AW Plus
gallon of water or according to the manufacturer recommendations.
3. Remove the instruments from the instrument case and place them into the washer
baskets.
4. Orient instruments in the automated washer's carriers as recommended by the washer
manufacturer.
5. The following automated cleaning cycle is recommended (minimum recommended times
are provided for each stage):
a. Pre-Wash 1: cold potable water, 2 minutes
b. Enzyme/Detergent treatment:
1. Spray, 20 seconds
2. Soak, 1 minute
3. Rinse cold potable water, 15 seconds
4. Rinse cold potable water, 15 seconds
c. Wash ≥ 65°C, 2 minutes using Endozime AW Plus
d. Rinse 1: hot potable water, 15 seconds
e. Rinse 2: hot potable water, 15 seconds
f. Rinse 3: hot potable water, 15 seconds
g. Rinse 4: hot potable water, 15 seconds
h. Thermal rinse ≥ 93°C for 1 minute
i. Heated USP Purified Water Rinse 1: re-circulating 10 seconds
j. Heated USP Purified Water Rinse 2: non re-circulating 10 seconds
k. Drying: 7 minutes, 115°C
l. Visually inspect the instruments for visible soil.
m. 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,
gauges, or are otherwise found defective. Do not use defective instruments.
Sterilization:
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation 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 44-9011, 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, Phoenix and JANUS 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
Firebird NXG and JANUS 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)
Exposure time: 4 minutes
Drying time: 30 minutes
3
®
IIse to 128.0 mL of potable tap
solution for 15 minutes.
®
®
or:
Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Exposure time: 8 minutes
or:
Method: Steam
Cycle: Prevac (minimum 4 pulses)
Temperature: 270°F (132°C)
Exposure time: 4 minutes
Drying time: 30 minutes
®
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