Cleaning and Sterilization Instructions
Toby Orthopaedics, Inc.
401 SW 42
Ave, Suite 200
Miami, Florida 33134 USA
Domestic Toll-free: 866.979.TOBY (8629)
Atlantico Systems LTD
Phone: +35 391443609
PANTERA Fracture Fixation Plate System
Point of Use
Implantable devices (plates, screws, etc.) are single use only.
Reusable instruments that are provided clean and ready to use are non-sterile unless
the packaging indicates otherwise.
Clean and sterilize prior to each use, unless device is already provided in clean / sterile
Where applicable, disassemble instruments prior to cleaning.
For additional warnings, reference the PANTERA Instructions For Use (Doc
Implantable devices are single use only and may not be reused once in contact with
bodily fluid, soft tissue, bone, or other sources of contamination.
Repeated processing has minimal effect on reusable PANTERA surgical instruments.
End of life is normally determined by wear and damage due to the use of the
The PANTERA system is indicated for fractures and fracture dislocations, osteotomies,
and non-unions of the proximal humerus.
The plates and screws contained within the system are single use devices, which are
designed for implantation per the relevant surgical procedure.
The drill bits, drill guides, depth gauges, k-wire, drivers, and other instrumentation are
designed for use during the surgical procedure and require decontamination and
cleaning prior to reuse. The instruments typically contact blood, bone, tissue and bodily
fluids during normal use, and therefore, require that the cleaning and processing steps
are completed for each usage.
Remove gross soiling by submerging the instrument into cold water (<40ºC)
immediately after use.
Don't use a fixating detergent or hot water (>40ºC) as this can cause the fixation of
residue, which may influence the result of the reprocessing process.
Remove surface contamination with paper tissue.
Hospital precautions for the handling of contaminated/bio-hazardous materials should
Instruments should be cleaned within 30 minutes after use to minimize the potential of
staining, damage, and drying.
If possible, the devices must be reprocessed in a disassembled or opened state.
Disassemble the Depth Gauge to clean each component of the assembly: Depth Gauge
Tip, Slide and Housing.
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a. Fully retract the Slide into the Housing so that the scale reads zero.
b. Apply angular pressure on the Tip until the groove is visible.
c. Fully separate the Tip from the Housing while taking care to not bend the Slide.
Remove the K-Wire sleeve(s) from the corresponding Post Drill Guide and Cross
Element Guide by turning the threaded sleeve counterclockwise.
Rinse with cold water for approximately 3 minutes.
Applicable towards reusable devices and instrumentation. All reusable instrumentation shall
be considered critical, especially the items with small lumens / cannula or silicone surfaces.
Immerse the device(s) in an enzymatic detergent solution prepared in warm (30-35ºC)
tap water (8 mL EcoLab Neutral Enzymatic Detergent per liter or equivalent detergent
solution) and allow device(s) to soak for not less than five (5) minutes.
Aspirate not less than sixty (60) mL of the detergent solution through any lumens
present, as applicable, using an appropriate sized syringe.
Brush all lumens present on device(s), as applicable, using an appropriately sized nylon
bristled channel brush. Wet the brush in the detergent solution and run the brush down
the entire length of each lumen and back, not less than five (5) times. The brush should
also be used to remove any visible soil.
Brush any silicone surface with a nylon bristled instrument cleaning brush for not less
than two (2) minutes per device where silicone material is present.
Prepare an enzymatic detergent solution in a sonicating water bath (35 kHz has shown
to be effective) using purified water (2 mL EcoLab Neutral Enzymatic Detergent per liter
of water or equivalent detergent solution).
Sonicate the device(s) for not less than ten (10) minutes in the enzymatic detergent
Upon completion of the manual brushing and sonication steps, process the device(s)
through a standard washer / disinfector surgical instruments cycle with the following
parameters (or equivalent):
Automated Cleaning Cycle Parameters
4 minutes heating from
35 to 60ºC,
4 minutes > 60ºC
5 minutes heating from
30 to 80ºC,
5 minutes > 80ºC
Perform a final rinse of the device(s) in running purified water, not less than ~250 mL
per device, and allow the device(s) to air dry.
Perform a visual inspection of the device(s) to ensure that all contaminants have been
removed. Residual bodily fluids, excessive discoloration, unacceptable corrosion, etc.,
are typical reasons to further process the device(s). If the device(s) are determined to
not be visually clean, the above relevant steps shall be repeated. If the device cannot
be cleaned effectively, then it shall be disposed of safely or Toby Orthopaedics’
Customer Service shall be contacted at the phone number listed above.
Automated systems are only recommended for the PANTERA surgical instruments when
combined with the manual cleaning procedure detailed in the section above.
Submerge instruments in a disinfection detergent according to the detergent
2. Rinse the instruments with sterile water to remove the detergent
Note: Disinfection is only a supplementary step and does NOT replace the steam
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Dry the instruments with a lint-free towel. The instruments may never be heated up >140ºC.
To avoid water residues, insufflate cavities of instruments by using sterile compressed air. It
is critical that all areas of the devices are completely dry, as residual moisture causes
possible corrosion and premature deterioration of the instrument.
Lubricate hinges, threads and other moving parts with a commercial water-based surgical
grade instrument lubricant (such as instrument milk) to reduce friction and wear.
Carefully inspect each device to ensure that all visible blood and soil has been removed.
Visually inspect for damage, corrosion and/or wear.
Check the action of moving parts to ensure smooth operation throughout the intended
range of motion.
4. Check instruments with long slender features (particularly rotating instruments) for
5. Where instruments form part of a larger assembly, check that the devices assemble
readily with mating components.
Note: If damage or wear is noted that may compromise the function of the instrument,
contact your Toby Orthopaedics representative for a replacement.
Implantable components may not be reused, but may be resterilized, as required,
through the moist heat method described herein. The implantable components have
been validated for undergoing at least 15 sterilization cycles without loss of
Drill guides, drill guide sleeves, drivers, and similar instruments may be reused as long
as the functionality of the device is sufficient to perform the intended use. Typically
these types of instruments have a lifetime of 50+ surgical cases unless the threads or
driver tip is damaged during use.
The depth gauge assembly and drill bits / k-wires may be reused as long as the
functionality of the device is sufficient and any marking used for measurements are
clearly legible. The depth gauge scale and other similar laser markings on these
devices begin to deteriorate after 10 to 15 sterilization / cleaning cycles, and should be
visually inspected to ensure accuracy is still guaranteed. The cutting edges of the drill
bits / k-wires deteriorate at various times based on use, and the drill bits should be
safely discarded once the edges become dull. The edges can become dull after one
use or may last 10 to 15 surgical cases. Dull drill bits should be safely discarded to
prevent localized burning of the bone during use. Similarly, it is not recommended that
K-wire or drill bits be reused for multiple cases due to the high velocity rotation of the
devices causing possible deformation of the item and deterioration of performance.
The sterilization trays are designed to last hundreds of sterilization / cleaning cycles and
only require replacement when functionality is lost or excessive contamination cannot
Instruments shall be loaded into the dedicated PANTERA sterilization tray for sterilization.
If applicable, use standard medical grade steam sterilization wrap following the AAMI double
wrap method (ANSI/AAMI ST79).
Steam sterilize using a pre-vacuum cycle for 3 minutes at a minimum temperature of 135ºC.
20 Minute minimum drying time in accordance with ANSI/AAMI ST79.
Note: Flash Sterilization is not recommended for PANTERA .
PANTERA surgical instruments should be stored in a cool dry place.
This document is in accordance with ISO 17664 current revision
CONFIDENTIAL: This document is property of Toby Orthopaedics, Inc., and shall not be reproduced or distributed without the
express written consent of Toby Orthopaedics, Inc...
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