3
AW-16-9901 Rev.BF
TX-2201 © Orthofix, Inc. 07/2022
Serial Number
Authorized
Representative
CAPA Symbols Chart revised2 - TDX - EN
See Instructions for Use
Lot Number
Manufacturer
Single Use Only
Do Not Reuse
Catalogue Number
Use By Date
Sterilized Using
Ethylene Oxide
Do Not Resterilize
Orthofix.com/IFU
sprays break down protein matter and prevent blood and protein based materials from drying
on instruments. Manufacturer’s instructions for preparation and use of these solutions should be
explicitly followed.
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.
Torque Limiting 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 TDX Posterior Dynamic Stabilization System Instruments should be sterilized by the hospital
using one of the following recommended cycles:
Method: Steam
or:
Method: Steam
Cycle: Gravity
Cycle: Prevac
Temperature: 250°F (121°C)
Temperature: 270°F (132°C)
Exposure time: 30 minutes
Exposure time: 8 minutes
The TDX Posterior Dynamic Stabilization System implants are provided STERILE. They are
sterilized using Ethylene Oxide sterilization. Do not re-sterilize.
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 TDX Posterior Dynamic Stabilization System instruments are provided in a modular case
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 are provided in sealed poly bags with individual product labels.
TDX Posterior Dynamic Stabilization System implants 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, telephone at 1-214-937-3199 or 1-888-298-5700 or by
e-mail at [email protected].
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 TDX Posterior Dynamic Stabilization
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:
The TDX Posterior Dynamic Stabilization System has not been cleared by the US Food
and Drug Administration and is not available in the United States.
