3
When using a mechanical washer, make sure all instruments stay properly in place and do not
touch or overlap each other. Always follow the manufacturer’s specifications for automatic wash-
ers and use a free-rinsing, low-sudsing detergent with a neutral pH (6.0 – 8.5). Due to variations
in water quality, the type of detergent and its concentration may require adjustment for optimal
cleaning.
Rinse all instruments thoroughly with tap water, de-ionized or distilled water to remove all traces
of debris and cleansing agents. Make sure all internal cavities and ratchets are thoroughly rinsed.
Visually inspect for any remaining soil. If necessary, using a soft brush, gently clean, paying close
attention to crevices and other hard to clean areas. Re-clean and rinse as described above, if
manual cleaning is performed.
Instruments must be thoroughly dried and all residual moisture must be removed before they are
stored. Allow to air dry, or use a soft, lint-free, absorbent towel/cloth to dry external surfaces.
All products should be treated with care. Improper use or handling may lead to damage and
possible improper functioning of the device.
Instructions for Assembly and Inspection:
1. Parallel Guide Set (PN 11-1109-FD7):
There are three parts to the Parallel Guide Set: 1. Locking Nut, 2. Sliding Block, and 3.
Parallel Guide Frame. The Parallel Guide Set requires assembly after cleaning using the
following steps:
a. Slide the Sliding Block through the underside of the Parallel Guide Frame with the
threads leading.
b. Slide the Nut over the Sliding Block’s shaft and thread it into place, making sure the
Sliding Block seats properly.
2. Packing Plunger (PN 11-1109-FD8-1) and Packing Tube (PN 11-1109-FD8-2):
There are two parts: 1. Packing Plunger and 2. Packing Tube (single use only). The Packing
Plunger and Packing Tube require assembly after cleaning using the following step:
a. Insert the Plunger into the Tube.
3. Variable Drill Bit (PN 11-1109-FD9-1) and Adjustable Drill Collar (PN 11-1109-FD9-2):
There are two parts: 1. Variable Drill Bit (single use only) and 2. Adjustable Drill Collar.
The Variable Drill Bit and Adjustable Drill Collar require assembly after cleaning using the
following steps:
a. Slide the Drill Collar, with the arrow pointing towards the proximal end of the Drill Bit,
over the Drill Bit Shank until the desired depth position is engaged.
b. Flex the parallel beams to release the Drill Collar from the detent engagement.
After cleaning and before use, inspect the instruments for possible damage, wear or non-
functioning parts. Discontinue use and replace all instruments that show wear, cracks, corrosion,
pitting, discoloration, etc. Damaged or defective instruments should not be used.
Sterilization:
The SambaScrew SI Fixation System implants and instruments are provided NON-STERILE and
must be thoroughly cleaned and sterilized prior to each use.
Place the dry instruments in the designated locations in the case (see markings on tray surface
that indicate proper storage location in the case).
Sterilization for Instrument Cases with Blue Wrap:
It is recommended to double wrap instrument cases in standard central supply FDA cleared wrap
prior to steam sterilization using the gravity cycles. A single wrap (or pouch) may be used for the
pre-vacuum cycle.
Only sterile products should be placed in the operative field. For a 10
-6
sterility assurance level,
these products are recommended to be steam sterilized by the hospital using one of the three
sets of process parameters below:
Sterilization Parameters for Use in the United States for Instrument Cases:
Method: Steam
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure time: 4 Minutes
Drying time: NA – Immediate Use Cycle
The following gravity sterilization cycles are not considered by the United States Food and Drug
Administration (US FDA) to be standard sterilization cycles. Users should only use sterilizers and
accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological
indicators, and sterilization containers) that have been cleared by the US FDA for the following
selected gravity sterilization cycle specification.
Method: Steam*
or:
Method: Steam
Cycle: Gravity
Cycle: Gravity
Temperature: 273°F (134°C)
Temperature: 250°F (121°C)
Exposure time: 20 Minutes*
Exposure time: 60 Minutes
Drying time: 15-30 Minutes
Drying time: 15-30 Minutes
Note:
Because of the many variables involved in sterilization, each medical facility should cali-
brate and verify the sterilization process (e.g., temperatures and times) used for their equipment.
*Some non-U.S. Health Care Authorities recommend sterilization according to these parameters
in order to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially for
surgical instruments that could come into contact with the central nervous system. This steriliza-
tion cycle has not been validated for prion inactivation.
Sterilization for Screw Caddy with Blue Wrap:
The SambaScrew SI Fixation System implants are supplied NON-STERILE. Prior to use, all
implants should be placed in the appropriate Orthofix caddy 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: Pre-vacuum (minimum 4 pulses)
Temperature: 270°F (132°C)
Temperature: 270°F (132°C)
Exposure time: 15 minutes
Exposure time: 4 minutes
Drying time: 30 minutes
Drying time: 30 minutes
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 care-
fully checked for damage prior to use. Damaged packages or products should not be used and
should be returned to Orthofix.
The SambaScrew SI Fixation System instruments and implants are provided in a modular case
and caddy specifically intended to contain and organize the system’s components. The system’s
instruments are organized in a modular case for easy retrieval during surgery. The modular case
also provides 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) 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, Lewis-
ville, TX 75056, USA, Telephone: 214-937-3199 or 1-888-298-5700 or via email at
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 SambaScrew SI Fixation 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.
AW-11-9901 Rev.AA
PK-1602-PL-US © Orthofix, Inc. 9/2016
Provided Non-Sterile
Authorised
Representative
CAPA Symbols Chart revised
See Instructions for Use
Lot Number
Manufacturer
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
