3
3. Used instruments must be transported to the central supply in closed or covered
containers to prevent unnecessary contamination risk.
Note:
Soaking in proteolytic enzymatic detergents or other pre-cleaning solutions facilitates
cleaning, especially in instruments with complex features and hard-to-reach areas (e.g.
cannulated and tubular designs, etc.). These enzymatic detergents as well as enzymatic foam
sprays break down protein matter and prevent blood and protein based materials from drying
on instruments. Manufacturer’s instructions for preparation and use of these solutions should be
explicitly followed.
Instructions for Disassembly:
1. Modular Implant Inserters:
There are three parts to each modular Implant Inserter: 1. Inserter Shaft, 2. Instrument Body
and 3. Threaded Insert. The Universal Implant Inserter Handle may also be attached. The
modular Implant Inserters require disassembly prior to cleaning using the following steps:
a. Grip the instrument at the gold-colored knob and Inserter Shaft with one hand.
b. With the other hand, hold the black silicone handle and pull the plunger away from
the Instrument Body.
c. While still pulling the plunger, rotate the handle clockwise until disengaged from the
Instrument Body. Set aside the Universal Implant Inserter Handle.
d. Hold the assembly level and grip the Instrument Body at the gold-colored knob with
the pronged tip pointed away from you.
e. Turn the ribbed collar on the Inserter Shaft and firmly rotate it clockwise to disengage
it from the Instrument Body. Completely unthread the ribbed collar until it slides down
and stops on colored ring.
f. Keep the ribbed collar away from the threaded side near colored ring and firmly tug
the Inserter Shaft with the other hand. Use caution to not drop the Threaded Insert out
of the Inserter Shaft.
g. Slowly tilt the Inserter Shaft so the prongs are higher than the ribbed collar to remove
the Threaded Insert. If the Threaded Insert does not disengage, gently tap the larger
opening onto the palm of your hand to remove it.
Preparation for Cleaning:
1. All instruments with moving parts (e.g., knobs, triggers, hinges) should be placed in the
open position to allow access of the cleaning fluid to areas that are difficult to clean.
2. Soak the instruments for a minimum of 10 minutes in purified water prior to the manual
or automated cleaning process.
3. Use a soft cloth or a soft plastic bristle brush to remove any visible soil from the
instruments prior to manual or automated cleaning. Use a soft plastic bristle brush
or a pipe cleaner to remove soil from any inner lumens. You can also use a syringe (if
appropriate) for hard to reach areas.
4. Enzymatic detergent should be used for manual and automated cleaning. All enzymatic
detergents should be prepared at the use dilution and temperature recommended by
the manufacturer. Softened tap water may be used to prepare the enzymatic detergents.
Use of recommended temperatures is important for optimal performance of enzymatic
detergent.
Manual Cleaning:
1. Completely submerge instruments in an enzymatic detergent and allow to soak for 20
minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has
been removed. Particular attention must be given to crevices, lumens, mated surfaces,
connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow,
soft-bristled brush (i.e. pipe cleaner brush).
2. Remove the instruments from the enzymatic detergent and rinse in tap water for a
minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other
difficult to reach areas.
3. Place prepared cleaning solution in a sonication unit. Completely submerge device in
cleaning solution and sonicate for 10 minutes.
4. Rinse instrument in purified water for at least 3 minutes or until there is no sign of blood
or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens,
holes and other difficult to reach areas.
5. Repeat the sonication and rinse steps above.
6. Remove excess moisture from the instrument with a clean, absorbent and non-shedding
wipe.
7. Inspect the instruments for visible soil.
8. If visible soil is noted, repeat the steps listed above.
Automated Cleaning:
1. Completely submerge the instruments in an enzymatic detergent and allow to soak and
sonicate for 10 minutes each. Use a soft nylon bristled brush to gently scrub the device
until all visible soil has been removed. Particular attention must be given to crevices,
lumens, mated surfaces, connectors and other hard to clean areas. Lumens should be
cleaned with a long, narrow, soft nylon bristled brush (i.e. pipe cleaner). Use of a syringe
or water jet will improve flushing of difficult to reach areas and closely mated surfaces.
2. Remove instruments from the cleaning solution and rinse in purified water for a minimum
of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult to
reach areas.
3. Place instruments in a suitable washer/disinfector basket and process through a standard
instrument washer/disinfector cleaning cycle.
4. Orient instruments into the automated washer’s carriers as recommended by the washer
manufacturer.
5. The following minimum parameters are essential for thorough cleaning.
a. 2 minute prewash with cold tap water
b. 1 minute prewash with hot tap water
c. 2 minute detergent wash with hot tap water (64-66°C/146-150°F)
d. 1 minute hot tap water rinse
e. 2 minute thermal rinse with purified water (80-93°C/176-200°F)
f. 1 minute purified water rinse (64-66°C/146-150°F)
g. 7 to 30 minute hot air dry (116°C/240°F)
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.
Instructions for Assembly and Inspections
1. Modular Implant Inserters:
There are three parts to each modular Implant Inserter: 1. Inserter Shaft, 2. Instrument
Body and 3. Threaded Insert. The modular Implant Inserters require assembly after
cleaning using the following steps:
a. Hold the Inserter Shaft so that the prongs are pointed toward the floor. Carefully insert
the Threaded Insert, threaded tip first, into the large opening on the Inserter Shaft.
b. Keep the prongs pointed toward the floor with the ribbed collar resting on the colored
ring in one hand, and insert the Instrument Body with the gold-colored knob into the
large opening on Inserter Shaft.
c. Turn the Instrument Body until it fully seats in the in the square connection. There
should be no gap between the Instrument Body and Inserter Shaft.
d. With the prongs still pointed toward the floor, raise the ribbed collar. Once the ribbed
collar is at the threads, rotate it counterclockwise until it clicks over the lip on the
Instrument Body and no gap remains between the ribbed collar and Instrument Body.
e. If placing the instrument in the Instrument Case, do not attach the Universal Implant
Inserter Handle, as it has a separate set of brackets than the Implant Inserter.
Instrument End of Life Determination:
Do not reuse Single Use instruments. Visually inspect the reusable instruments to determine if
the instrument has reached end of life. Orthofix reusable instruments have reached End of Life
when:
1. Instruments show signs of damage such as binding, bending, breakage, overt signs of
wear and/or any other conditions which may impact the devices safe and effective use.
2. Instruments intended for cutting bone and/or tissue (e.g. tap, rasp, curette, rongeur)
– when any of the cutting surfaces show signs of wear such as nicks, abrasions or
otherwise dulled cutting surfaces.
3. Instruments that interface with other devices (e.g. implants, instruments, handles) - when
the mating feature binds, fails to attach or fails to hold the device securely. The instrument
function should be verified prior to each use.
4. Do not use instruments which reached End of Life. Discard End of Life instruments per
your hospital procedure or return to Orthofix for disposal.
Sterilization:
The FORZA PTC Spacer System implants are supplied STERILE. They are sterilized using gamma
irradiation sterilization. Do not re-sterilize.
Sterilization in Orthofix Cases with Blue Wrap:
FORZA PEEK Spacer System instruments are compatible for use with the FORZA PTC Spacer
System implants and are supplied NON-STERILE. Prior to use, all instruments 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
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 case (recommended 23¼” long x 11¼” wide container). Based on
the rigid sterilization container size, the FORZA Discectomy Case may require removal of the lid
prior to insertion into the sterilization container. The following sterilization cycle was 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 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:
The FORZA PTC Spacer System implants are sterilized using Gamma irradiation sterilization. Do
not re-sterilize.
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.
FORZA Spacer System instruments 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.
