Orthofix CONSTRUX Mini PEEK Instrucciones De Uso página 3

Automated Cleaning:
1. Use a soft cloth or soft plastic bristle brush to remove any visible soil from the outside
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 as 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, 1 minute
i. Heated USP <1231> Purified Water Rinse 1: re-circulating 10 seconds
j. Heated USP <1231> Purified Water Rinse 2: non re-circulating 10 seconds
k. Dry at 115°C, 7 minutes
6. Visually 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 if instruments are broken, discolored, corroded, have cracked components, pits, gouges,
or otherwise found defective. Do not use defective instruments.
Sterilization:
Sterilization in Orthofix Cases with Blue Wrap:
The CONSTRUX Mini PEEK VBR System implants and instruments are supplied NON-STERILE.
Prior to use, all implants and instruments should be placed in the instrument/implant case which
will be wrapped in an FDA cleared sterilization wrap and placed in the autoclave for sterilization
by the hospital using one of the following recommended cycles:
Method: Steam or:
Cycle: Gravity
Temperature: 270°F (132°C
Exposure time: 15 minutes
Drying time: 30 minutes
Double wrapped
AW-47-9902 Rev.AA
CO-1602 © Orthofix, Inc. 11/2016
per
®
®
Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Preconditioning: 4 Pulses
Exposure time: 4 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 instrumentation cases (recommended 23¼" long x 11¼" wide
container). The following sterilization cycle has been validated:
Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Preconditioning: 4 Pulses
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 as 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
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 CONSTRUX Mini PEEK VBR 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 are provided in sealed poly bags with individual product labels.
Product Complaints:
Any Healthcare 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 email at complaints@orthofix.com.
Further Information:
A recommended operative technique for the use of this system is available upon request. Please
contact Orthofix using the information listed above.
Latex Information:
The implants, instruments and/or packaging material for the CONSTRUX Mini PEEK VBR 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.
CAPA Symbols Chart revised2 - CONSTRUX Mini PEEK - EN
3
Federal (U.S.A.) law restricts this device to sale
by or on the order of a physician
Catalogue Number
See Instructions for Use
Orthofix.com/IFU
Manufacturer
Single Use Only Authorized
Representative
Do Not Reuse
Provided Non-Sterile
Serial Number
Lot Number
.
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