Further Information - Orthofix PILLAR SA PEEK Instrucciones De Uso

Automated Cleaning:
1. Upon completing the preparation for the cleaning procedure, set up the washer/disinfector
detergent dose at ½ ounce of Endozime AW Plus
manufacturer recommendations.
2. If visible soil is noted, scrub instruments with a soft plastic bristle brush and use the
brush or a pipe cleaner long enough to reach the entire length of any interior lumen(s) to
remove the soil.
3. Place scrubbed instruments into the washer baskets.
4. Orient instruments into 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 with enzyme/detergent, 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. 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.
Sterilization:
Sterilization in Orthofix Cases with Blue Wrap:
The PILLAR SA PEEK Spacer System instruments and implants are supplied NON-STERILE. Prior to
use, all instruments and implants should be placed 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 or:
Cycle: Gravity
Temperature: 270°F (132°C)
Exposure time: 15 minutes
Drying time: 30 minutes
Double wrapped
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
AW-49-9902 Rev.AC
PK-1802 © Orthofix, Inc. 9/2018
per gallon of water or according to the
®
®
Method: Steam
Cycle: Prevac
Temperature: 270°F (132°C)
Preconditioning: Per manufacturer's settings
Exposure time: 4 minutes
Drying time: 30 minutes
Double wrapped
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 PILLAR SA 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 and
implants 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 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 PILLAR SA PEEK 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 these devices to sale by or on the order of a physician.
CAPA Symbols Chart revised2 - Pillar SA - EN
3
Federal (U.S.A.) law restricts this device to sale
by or on the order of a physician
See Instructions for Use Manufacturer
Authorized
Orthofix.com/IFU
Representative
Single Use Only
Serial Number
Do Not Reuse
Catalogue Number
Lot Number
Provided Non-Sterile