3
AW-39-9901 Rev.AA
PK-1602-PL-US © Orthofix, Inc. 7/2016
Provided Non-Sterile
Serial Number
Authorised
Representative
CAPA Symbols Chart revised
See Instructions for Use
Sterilized Using
Irradiation
Do Not Resterilize
Lot Number
Manufacturer
Use By Date
Federal (U.S.A.) law restricts this device to sale
by or on the order of a physician
Single Use Only
Do Not Reuse
Catalogue Number
Manual Cleaning:
1. Upon completing the preparation for the cleaning procedure, prepare the Vesphene
®
IIse
agent per the dilution recommended on the label directions (1 ounce per gallon), or 1 mL
of Vesphene
®
IIse to each 128 mL of potable tap water per the manufacturer’s Directions
for Use label.
2. Bathe instruments in prepared room temperature solution.
3. Manually agitate instruments in Vesphene
®
IIse solution for 15 minutes.
4. 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.
5. Rinse the instruments in USP <1231> purified water for 1.5 minutes.
6. Hang dry the device.
7. Inspect the instruments for visible soil.
8. If visible soil is noted, repeat the steps listed above.
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
®
per gallon of water or according to the
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, glutaralde-
hyde, 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:
The PILLAR SA PTC spacers are provided STERILE. They are sterilized using gamma irradiation
sterilization. Do not re-sterilize.
Sterilization in Orthofix Cases with Blue Wrap:
The PILLAR SA bone screws, plates and instruments are supplied NON-STERILE. Prior to use, all
non-sterile 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:
Method: Steam
Cycle: Gravity
Cycle: Prevac
Temperature: 270°F (132°C)
Temperature: 270°F (132°C)
Exposure time: 15 minutes
Preconditioning: 4 Pulses
Drying Time: 30 minutes
Exposure time: 4 minutes
Double wrapped
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
.
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 PTC instruments, bone screws, and plates are provided in a modular case specifi-
cally 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.
PILLAR SA PTC spacers 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 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 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 these devices to sale by or on the order of a physician.
