Packaging; Further Information - Orthofix CONSTRUX Mini PTC Gebrauchsanleitung

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 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.
AW-37-9901 Rev.AJ
CO-2008 © Orthofix, Inc. 2/2021
Sterilization:
CONSTRUX Mini PTC Spacer System implants are provided STERILE. They are sterilized using
gamma irradiation sterilization. Do not re-sterilize.
Sterilization in Orthofix Cases with Blue Wrap:
The CONSTRUX Mini PEEK Spacer System instruments are supplied NON-STERILE and are
compatible for use with the CONSTRUX Mini PTC Spacer System. Prior to use, all instruments
should be place in the appropriate Orthofix case which will be wrapped in a FDA cleared
sterilization wrap 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
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 a filtered or solid bottom to
properly enclose the Orthofix case (recommended 23¼" long x 11¼" wide container). The
following sterilization cycle has been validated:
Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Exposure time: 4 minutes
Drying time: 30 minutes
Note: Rigid sterilization containers with solid bottoms cannot be used in gravity steam cycles.
Validation and routine monitoring should be performed per ANSI/AAMI ST79 Comprehensive
guide to steam sterilization and sterility assurance in health care facilities. Other cycles may be
used as long as they comply with the above practices and provide a sterility assurance level
of 10 -6 .

Packaging:

CONSTRUX Mini PTC implants are provided STERILE. Do not use if the package is opened or
damaged or if the expiration date has passed.
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 CONSTRUX Mini Spacer System instruments 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 are provided in sealed poly bags with individual product labels.
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 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 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 CONSTRUX Mini PTC Spacer 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 this device to sale by or on the order of a physician.
3
or: Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Exposure time: 4 minutes
Drying time: 30 minutes
Double wrapped
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
Authorized
Single Use Only
Representative
Do Not Reuse
Catalogue Number
Do Not Resterilize
Provided Non-Sterile
Serial Number
Sterilized Using
Lot Number
Irradiation