FOR US AUDIENCES ONLY
0380035E Rev. G
Medtronic Reusable Instruments and
Accessories
2021-01-26
IMPORTANT INFORMATION FOR MEDTRONIC REUSABLE INSTRUMENTS AND
ACCESSORIES
DESCRIPTION
Reusable instruments are manufactured from a variety of materials commonly used in orthopedic and neurological procedures,
which meet applicable national and/or international standards. These instruments may be shipped in Medtronic Transportation/
Sterilization Cassettes. The Medtronic Transportation/Sterilization Cassettes are designed to be used in conjunction with a
legally marketed, validated, and FDA-cleared sterilization wrap to allow steam sterilization of non-sterile devices.
Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a
variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize
Medtronic orthopedic or neurological non-sterile devices. The Medtronic Transportation/Sterilization Cassettes are not intended
on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared
sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.
INTENDED USE
These orthopedic manual surgical instruments are intended for use in surgical procedures to manipulate tissue, bone, or for use
with other devices in orthopedic surgery. An instrument may incorporate a measuring function which has uses as described on
the label and the instrument.
DO NOT IMPLANT THE INSTRUMENTS.
The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize,
transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic
Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction
with a legally marketed, validated, FDA-cleared sterilization wrap.
Medtronic does not and cannot warrant the use of these instruments or Medtronic Transportation/Sterilization Cassettes nor any
of the component parts upon which repairs have been made or attempted, except as performed by Medtronic or an authorized
Medtronic repair representative. Implied warranties of merchantability and fitness for a particular purpose or use are specifically
excluded.
WARNINGS
▪ Breakage, slippage, misuse, or mishandling of instruments or Medtronic Transportation/Sterilization Cassettes, such as on
sharp edges, may cause injury to the patient, or surgical or processing personnel.
▪ Improper maintenance, handling, or inadequate cleaning procedures can render the instrument or Medtronic
Transportation/Sterilization Cassettes (cases, trays, lids) unsuitable for their intended purpose or may even be dangerous to
the patient or surgical or processing personnel.
▪ There are particular risks involved in the use of instruments used for bending and cutting rods. Use of these types of
instruments can cause injury to the patient by virtue of the extremely high forces required. Do not cut rods in situ. Any
breakage of an instrument or implant in this situation could be extremely hazardous. The physical characteristics required
for many instruments do not permit them to be manufactured from implantable materials, and if any broken fragments of
instruments remain in the body of a patient, the patient could have allergic or infectious consequences.
▪ The surgeon should use extreme caution when working in close proximity to vital organs, nerves, or vessels. Excessive
force should not be used when positioning instruments, since it could cause injury to the patient.
▪ Correct handling of Medtronic Transportation/Sterilization Cassettes is extremely important. Do not modify Medtronic
Transportation/Sterilization Cassettes. Do not notch or bend Medtronic Transportation/Sterilization Cassettes. Notches,
scratches, or other damage and/or wear in Medtronic Transportation/Sterilization Cassettes occurring during surgery may
contribute to breakage.
PRECAUTIONS
▪ Excessive force applied by instruments to implants can dislodge devices, particularly hooks.
▪ Exposing instruments or Medtronic Transportation/Sterilization Cassettes to temperatures in excess of 275°F (135°C) may
modify the physical characteristics. If instruments or Medtronic Transportation/Sterilization Cassettes are exposed to
temperature exceeding 275°F (135°C), perform an additional inspection to ensure they function as intended. See the
EXAMINATION section for more information.
▪ Extreme care should be taken to ensure instruments and Medtronic Transportation/Sterilization Cassettes remain in good
working order. During the procedure, the proper functioning of instruments and Medtronic Transportation/Sterilization
Cassettes is extremely important. Instruments or Medtronic Transportation/Sterilization Cassettes should not be bent or
damaged.
▪ Misuse of instruments or Medtronic Transportation/Sterilization Cassettes, resulting in corrosion, “freezing-up”, scratching,
loosening, bending, or fracture of components of an instrument or Medtronic Transportation/Sterilization Cassette may
inhibit or prevent proper function.
▪ Instruments should be carefully placed on trays, cleaned after each use, and stored in a dry environment.
▪ Do not use instruments for any action for which they were not intended.
▪ Regularly review the operational state of all instruments and, if necessary, contact Medtronic or an authorized Medtronic
repair representative.
▪ To avoid injury, the instrument should be carefully examined for functionality or damage prior to use. A damaged instrument
should not be used. Additional back-up instruments should be available.
▪ Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in the
successful use of instruments by the surgeon. The proper selection and the compliance of the patient will greatly affect the
results.
▪ Proper patient selection and operative care are critical to the success of the surgery and avoidance of injury during surgery.
Read and follow all other product information supplied by the manufacturer.
▪ Special precautions are needed during pediatric use. Care should be taken when using instruments in pediatric patients,
since these patients can be more susceptible to the stresses involved in their use.
▪ Ensure instruments with a measuring function are not worn and any surface engravings are clearly visible.
▪ Medtronic Transportation/Sterilization Cassettes are subjected to repeated stresses related to routine transportation,
cleaning, and sterilization processes. Medtronic Transportation/Sterilization Cassettes should be carefully inspected before
each use to ensure they are fully functional.
▪ Medtronic Transportation/Sterilization Cassettes are not to exceed a maximum weight and load distribution of 11.4kg/25lbs.
▪ Dissimilar metals should be separated from direct contact during sterilization to resist corrosion. Medtronic Transportation/
Sterilization Cassettes are designed with coated or silicone brackets to prevent contact with the stainless steel instruments
contained within Medtronic Transportation/Sterilization Cassettes.
POSSIBLE ADVERSE EFFECTS
▪ Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs, or joints.
▪ Infection if instruments or Medtronic Transportation/Sterilization Cassettes are not properly processed.
▪ Pain, discomfort, or abnormal sensations resulting from the presence of the device.
▪ Nerve damage due to surgical trauma.
▪ Dural leak in cases of excessive load application.
▪ Impingement of close vessels, nerves, and organs by slippage or misplacement of the instrument.
▪ Damage due to spontaneous release of clamping devices or spring mechanisms of certain instruments.
▪ Cutting of skin or gloves of surgical or processing personnel.
▪ Bony fracture in cases of deformed spine or weak bone.
▪ Tissue damage to the patient, physical injury to surgical personnel, and/or increased operating time that may result from the
accidental disassembly of multi-component instruments occurring during surgery.
▪ The methods of use of instruments are determined by the user’s experience and training in surgical procedures. A
successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other
patient conditions may compromise the results.
Physician note: although the physician is the learned intermediary between the company and patient, the important medical
information given in this document should be conveyed to the patient.
For US audiences only
Caution: Federal (US) law restricts these devices to sale by or on the order of a physician.
These devices should only be used by physicians familiar with the devices, their intended use, any additional instrumentation,
and any available surgical techniques. In addition, these devices should only be processed by operators familiar with the
devices and the processing information contained within this document.
PACKAGING
Instruments may be shipped in stand-alone packaging or in Medtronic Transportation/Sterilization Cassettes. Stand-alone
packaging, Medtronic Transportation/Sterilization Cassettes, and the contained medical devices should be intact upon receipt.
Medtronic Transportation/Sterilization Cassettes and contained medical devices should be checked for completeness and
should be checked for signs of damage prior to use. Damaged packages, cassettes, or instruments should not be used and
should be returned to Medtronic.
EXAMINATION
Instruments must always be examined by the user pre/post cleaning and prior to surgery. Examination should be thorough and
must include a visual and functional inspection of the working surfaces, pivots, racks, spring or torsional operation, cleanliness
of location holes or cannulations, and the presence of any cracks, bending, deformation, or distortion, and that all components
are complete.
Medtronic Transportation/Sterilization Cassettes must be examined by the user prior to use. Examination should be thorough
and must include a visual and functional inspection. Examination must also ensure the Medtronic Transportation/Sterilization
Cassettes are complete. Do not proceed with processing of damaged Medtronic Transportation/Sterilization Cassettes.
Never use instruments or Medtronic Transportation/Sterilization Cassettes with obvious signs of excessive wear, damage, or
that are incomplete or otherwise non-functional.
Visual Inspection
As applicable, ensure the following:
Instruments:
▪ All laser markings and other markings are legible.
▪ No cracks are present in instrument handles or any part of the instrument.
▪ Discoloration, corrosion, stains, or rust does not exist. If present, follow the instructions in the Limitations on Processing
section of this document.
▪ There is no handle/shaft separation, and the handle-to-shaft connection is secure.
▪ No cuts or gouges in silicone are present.
▪ There is no damage (cuts, tears, etc.) to the insulation.
▪ There is no damage to the working ends or tips. The working end should be free of cracks, sharp edged gouges, and other
damage. When applicable, the working end should be sharp.
▪ There is no damage to threads.
▪ All parts are present and free of damage and deterioration. Examples of parts that may be missing, loose, or damaged
include set screws, springs, curved springs, pins, and prongs.
▪ Mating ends are free of damage (nicks, gouges, bends, etc.) that would interfere with the mating function.
▪ Cannulated instruments with a guide wire or other insertion tool are visually checked.
Medtronic Transportation/Sterilization Cassettes (cases, trays, lids):
▪ All laser markings and other markings are legible.
▪ No cracks, deformation, or distortion are present.
▪ No discoloration, corrosion, stains, or rust are present.
▪ No cuts or gouges in silicone brackets are present.
▪ No cracks or peeling of nylon coating on metal brackets.
▪ Latches, caddies, modules, or lids, fit/function correctly.
Functional Inspection
As applicable, ensure the following:
Instruments:
▪ Any moving parts move freely, without sticking, binding, or grinding.
▪ Springs return the handle of the instrument to its original position.
▪ Retention tabs hold appropriate mating parts and are not damaged.
▪ The instrument will function as intended with the appropriate mating parts.
▪ Ball detents will hold mating parts and are free from damage.
▪ Sharp edges are sharp to the touch and are not dull, have no nicks, or any other damage.
▪ Tips meet when appropriate.
▪ Ratcheting mechanisms are functional. This includes handles, latches, and other mechanisms. All teeth should be present
and functional.
▪ Driver tips are not worn beyond functional use. If necessary, mate the instrument with the appropriate part.
Medtronic Transportation/Sterilization Cassettes:
▪ Any moving parts move freely without sticking, binding, or grinding.
▪ There should be no sharp edges on cassettes.
▪ Latches, caddies, modules, and/or lids, fit correctly.
PROCESSING - GENERAL CONSIDERATIONS
Cleaning is the removal of organic soil. Effective cleaning:
▪ Minimizes the organic soil transfer from one patient to another.
▪ Prevents accumulation of residual soil throughout the product’s use life.
▪ Allows for successful follow up sterilization. Adequate processing is contingent upon the thoroughness of cleaning.
Cleaning is the initial step and sterilization occurs later in processing and is intended to kill microorganisms to reduce the
likelihood of transmission and possibilities of infection. To ensure acceptable processing, there should be no delay between the
steps in this document.
Instruments may be safely and effectively processed using manual or a combination of manual and automated washerdisinfector (enzymatic or alkaline) cleaning procedures outlined in this document. Medtronic Transportation/Sterilization
Cassettes may be safely and effectively processed using manual or a combination of manual and automated washer-disinfector
(enzymatic) cleaning procedures outlined in this document.
The processor should comply with local laws and ordinances in countries where processing requirements are more stringent
than those detailed in this document.
Bloodborne Pathogens
Universal precautions for handling instruments and Medtronic Transportation/Sterilization Cassettes after use should be
observed by all hospital personnel according to OSHA Standard 29 CFR 1910.1030 regarding occupational exposure to
bloodborne pathogens.
Cleaning Agents and Cleaning Tools
Instruments: use of neutral detergents, enzymatic cleaners (7.0 – 8.0 pH), alkaline cleaning agents (8.0 – 11.0 pH), soft bristled
brushes, and soft pipe cleaners are recommended. High alkaline cleaning agents (>11.0 pH) should not be used.
Note: alkaline cleaning agents may require neutralization following cleaning. Refer to manufacturer’s instructions to determine if
neutralization is required and follow manufacturer’s instructions for neutralization. It is critical that alkaline cleaning solutions be
properly neutralized and rinsed from instruments.
Medtronic Transportation/Sterilization Cassettes: use of neutral detergents, enzymatic cleaners (7.0 – 8.0 pH) soft bristled
brushes and soft pipe cleaners are recommended. Do not use alkaline cleaning agents as the alkaline cleaners will cause
significant damage and render Medtronic Transportation/Sterilization Cassettes unusable.
The following cleaning agents, solutions, or tools should
Cassettes:
not be used on instruments or Medtronic Transportation/Sterilization
▪ Saline solution.
▪ Solutions containing chlorine (e.g. bleach) or aldehydes (e.g. glutaraldehyde).
▪ Formalin, mercury, chlorides, bromides, iodides, or Ringer's solution.
▪ Metal brushes or scouring pads.
Cleaning and Rinsing Water
If available, softened tap water should be used. Critical water should be used for the final rinse step to prevent mineral deposits
on surfaces (de-ionized water is recommended). One or more of the following processes may be used to treat water defined as
critical water: ultra-filtered (UF), reverse osmosis (RO), de-ionized (DI), or equivalent. Use of hard water should be avoided.
Use of Mineral Oil or Silicone-Based Lubricants
Mineral oil or silicone-based lubricants should not be used as they may not be removed by these cleaning instructions. These
types of lubricants may coat microorganisms, prevent direct contact of steam with instrument surfaces, and hinder sterilization.
Processing Warnings/Cautions
▪ Do not allow soiled instruments or Medtronic Transportation/Sterilization Cassettes to dry after use and prior to cleaning.
Cleaning and subsequent sterilization may be hindered when blood or bloody solutions are allowed to dry on instruments or
Medtronic Transportation/Sterilization Cassettes.
▪ Medtronic reusable instruments are considered critical devices (i.e. critical contact) and must be thoroughly cleaned, then
sterilized prior to initial use, or in adherence to these processing instructions before reuse.
▪ Soiled or used instruments should not be loaded into Medtronic Transportation/Sterilization Cassettes for cleaning in an
automated washer-disinfector. Instruments must be cleaned separately from Medtronic Transportation/Sterilization
Cassettes.
▪ Medtronic Transportation/Sterilization Cassettes can only be cleaned using enzymatic (neutral) cleaning solutions.
▪ Certain solutions, (i.e. alkaline based and/or containing bleach, glutaraldehyde, or formalin) may significantly damage the
Transportation/Sterilization Cassettes. These solutions must not be used.
▪ Universal precautions should be observed by all health care facility personnel that work with contaminated or potentially
contaminated instruments or Medtronic Transportation/Sterilization Cassettes. Caution should be exercised when handling
instruments with sharp points or cutting edges.
▪ Appropriate PPE should be worn when handling or working with contaminated or potentially contaminated materials,
devices and equipment. PPE may include gowns, masks, goggles, face shields, gloves, and shoe covers.
▪ Do not place heavy instruments on top of delicate instruments.
▪ Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization
moisture caused by rapid cooling.
Limitations on Processing
▪ Repeated processing has minimal effect on these instruments or Medtronic Transportation/Sterilization Cassettes.
▪ End of life is determined by excessive wear and damage from normal use. The treatment of instruments or Medtronic
Transportation/Sterilization Cassettes, materials used, and details of cleaning and sterilization have an important effect. For
all practical purposes, there is no limit to the number of times instruments and Medtronic Transportation/Sterilization
Cassettes can be processed.
▪ See the EXAMINATION section of this document including the Visual and Function inspection subsections to determine if
the device is at the end of its useful life.
INSTRUCTIONS - Instruments Only
(Instructions for Medtronic Transportation/Sterilization Cassettes are included after the instructions for the
instruments)
Bringing a new
instrument into
service
Point of use
▪ Instruments are provided non-sterile and must be thoroughly cleaned, then sterilized before the first use
and any reuse.
▪ Remove all packaging material prior to cleaning and sterilization.
▪ Remove all visible soil from instruments using non-shedding wipes.
▪ Instruments should be thoroughly cleaned within 30 minutes of use to minimize the potential for drying.
▪ If the instruments cannot be processed immediately, keep the devices moist during transport.
▪ Place instruments in a tray of softened tap water, if available, or cover with damp towels.
Containment and
transportation
▪ Immediately transport the tray containing the covered instruments to a work area dedicated to further
processing.
▪ Soiled instruments should be transported separately from non-contaminated instruments to avoid
contamination of personnel and surroundings.
Preparation for
cleaning
▪ Instruments that require disassembly prior to cleaning are provided with specific processing/
disassembly/reassembly instructions. For additional details, refer to the specific processing/
disassembly/reassembly instructions for the instruments.
▪ Remove any occlusions prior to cleaning. Flush cannulated devices with tap or critical water to prevent
the drying of soil and/or debris.
▪ Instruments may be safely and effectively processed using manual or a combination manual and
automated washer-disinfector (enzymatic or alkaline) cleaning procedures outlined in Tables 1 and 2.
Automated
cleaning:
enzymatic or
alkaline
1. Rinse, flush, and scrub instruments under running (cold) tap water at a temperature of <110°F (<43°C)
for 30 seconds to 1 minute. Scrub instruments with appropriately-sized, soft bristle brushes to remove
visible soil. Scrub inside any lumens or cavities and actuate device (if applicable).
2.
Using tap water, prepare an enzymatic cleaning solution
solution
recommendations, and temperatures in an appropriately-sized sonicator.
3. Place instruments in the enzymatic or alkaline cleaner, submerge completely, and ultrasonicate at 40 –
50 kHz for a minimum of 15 minutes. Ensure all surfaces, lumens, and components are in contact with
the cleaning solution.
Note: ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning
solution. Air pockets will decrease the efficacy of the ultrasonic cleaning. Minimize air pockets or bubble
formation by flushing lumens, cavities, crevices, or springs with cleaning solution while the instrument is
immersed in the ultrasonic reservoir.
4. Transfer the instruments to the automated washer-disinfector and program the washer-disinfector with
the cycle parameters listed in Table 1 (enzymatic) or Table 2 (alkaline). Ensure instruments that are
cannulated and/or have blind holes are positioned in the washer-disinfector to allow proper drainage,
and pooling of wash water does not occur. Ensure the cycle parameters in Table 1 or Table 2 are
properly programmed.
5. Upon unloading, visually inspect instruments, including any lumens and cavities, to ensure all visible
soil has been removed. If soil is still present, repeat the cleaning process or contact Medtronic
immediately to arrange for disposal or replacement. Do not proceed with processing of a soiled
instrument.
Table 1: Enzymatic Cleaner (7.0 – 8.0 pH)
Pulsed enzymatic
2
(described after Table 2) according to the manufacturer’s instructions, dilution
Cycle Temperature set
points
Pre-wash <110°F (<43°C)
Cold tap
Wash Hot tap 10:00 0.2 – 0.8 mL/liter
wash
Detergent wash
(Neutral pH)
Rinse 160°F (71°C) 15:00 N/A
Rinse Hot tap ≥00:15 N/A
149°F (65°C) 5:00 0.2 – 0.8 mL/liter
1
(described after Table 1) or alkaline cleaning
Minimum time
(min:s)
2:00 N/A
Concentration
INSTRUCTIONS - Instruments Only
(Instructions for Medtronic Transportation/Sterilization Cassettes are included after the instructions for the
instruments)
Table 1: Enzymatic Cleaner (7.0 – 8.0 pH) (continued)
Cycle Temperature set
points
Thermal rinse
200°F (93°C) 5:00 N/A
Minimum time
(min:s)
Concentration
(critical water)
Dry 210°F (98.8°C) ≥30:00 N/A
1
Note: cycle validated using Prolystica Enzymatic Presoak and Cleaner
(1-4 mL/liter) for ultrasonication
and Prolystica Ultra Concentrate Enzymatic Cleaner and Prolystica Neutral Detergent for washerdisinfector use.
Table 2: Alkaline cleaning agent (8.0 – 11.0 pH)
Cycle Temperature set
points
Pre-wash <110°F (<43°C)
Minimum time
(min:s)
2:00 N/A
Concentration
Cold tap
Pulsed alkaline
wash
Wash Hot tap 10:00 2 – 6 mL/liter
Rinse Hot tap ≥00:15 N/A
Alkaline detergent wash 140°F (60°C) 5:00 2 – 6 mL/liter
Rinse 160°F (71°C) 15:00 N/A
Thermal rinse
200°F (93°C) 5:00 N/A
(critical water)
Dry 210°F (98.8°C) ≥30:00 N/A
2
Note 1: cycle validated using neodisher MediClean Forte
(5-10 mL/liter: ultrasonication; 2-6 mL/liter:
washer-disinfector). A neutralizing step is not required for neodisher MediClean Forte. However, other
alkaline cleaning agents may require this step. Refer to manufacturer’s instructions to determine if
neutralization is required.
Note 2: due to the many variables involved with washer-disinfectors, each health care facility should
properly install, calibrate, and verify the process (e.g. temperatures, times) used for their equipment.
Washer-disinfector manufacturer recommendations should always be followed. When cleaning multiple
devices in one cleaning cycle, ensure the manufacturer’s maximum load is not exceeded. Cleaning
validation was conducted using a full chamber load.
Manual cleaning:
enzymatic
1. Manually clean instruments only when an automated washer-disinfector is not available.
2. Disassemble instruments, if applicable.
3. Rinse, flush, and scrub instruments under running (cold) tap water at a temperature of <110°F (<43°C)
for a minimum of 3 minutes. Scrub instruments with appropriately-sized, soft bristle brushes or pipe
cleaners to remove visible soil. Scrub inside any lumens or cavities and actuate device (if applicable).
4. Scrub until all visible soil is removed.
5. Using tap water, prepare an enzymatic cleaning solution according to the manufacturer’s instructions,
dilution recommendations, and temperatures.
6. Place instruments in the enzymatic cleaner, submerge completely, and soak 45 - 60 minutes. Ensure
all surfaces, lumens, and components are in contact with the cleaning solution.
7. Remove instruments from the enzymatic cleaning solution and flush under running (cold) tap water.
Flush any lumens or cavities in the water stream. Rinse with (cold) tap water for a minimum of 3
minutes.
8. Using tap water, prepare a second enzymatic cleaning solution according to the manufacturer’s
instructions, dilution recommendations, and temperature in an appropriately-sized sonicator.
9. Place instruments in the enzymatic cleaning solution, submerge completely, and ultrasonicate at 40 –
50 kHz for a minimum of 45 minutes. Ensure all surfaces, lumens, and components are in contact with
the cleaning solution.
Note: ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning
solution. Air pockets will decrease the efficacy of the ultrasonic cleaning. Minimize air pockets or bubble
formation by flushing lumens, cavities, crevices, or springs with cleaning solution while the instrument is
immersed in the ultrasonic tank.
10. Remove the instruments from the ultrasonicator and rinse using (cold) running tap water. Flush any
lumens or cavities in the water stream. Rinse for a minimum of 3 minutes.
11. Repeat rinsing as in step 10, this time with critical water for an additional 3 minutes.
INSTRUCTIONS - Instruments Only
(Instructions for Medtronic Transportation/Sterilization Cassettes are included after the instructions for the
instruments)
12. Carefully visually inspect instruments, including any lumens and cavities, to ensure all visual soil has
been removed. If any soil is still present, repeat the cleaning process or contact Medtronic immediately
to arrange for disposal or replacement. Do not proceed with processing of a soiled instrument.
Thermal rinse
▪ Decontaminate the devices by a thermal final rinse within an automated washer-disinfector at 200°F
(93°C) for 5 to 10 minutes.
▪ Disinfection with disinfectant solutions or chemicals is not required because the decontamination
process includes cleaning followed by sterilization.
▪ Thermal rinse alone does not render the instruments safe for patient use.
Drying: automated
washer-disinfector
▪ Upon completion of washer-disinfector cycle perform a visual inspection for dryness.
▪ If moisture is observed on instruments after the washer-disinfector cycle, dry using clean, absorbent,
non-shedding wipes, forced (medical grade) air, and/or dry heat oven at ≥245°F (≥118°C) for a
minimum of 30 minutes.
▪ For complex instruments [e.g. shaft within lumen configurations, fine channels (cannulations) and
mating articulating surfaces], a dry heat oven at ≥245°F (≥118°C) for a minimum of 30 minutes is
required. Perform a visual inspection for dryness.
▪ Instruments should be completely dry before packaging for sterilization.
Drying: manual
▪ Dry the devices using clean, absorbent, non-shedding wipes and/or forced (medical grade) air, and/or a
dry heat oven. Perform a visual inspection for dryness and repeat if necessary.
▪ Instruments should be completely dry before packaging for sterilization.
Inspection and
reassembly
▪ If the instrument was disassembled prior to cleaning, reassemble, if applicable.
▪ Carefully inspect the instrument for damage by performing a thorough examination as referenced in the
EXAMINATION section of this document.
▪ If the instrument is damaged, contact Medtronic immediately to arrange for disposal or replacement. Do
not proceed with processing of a damaged device.
Packaging
▪ A standard non-woven/moisture resistant surgical sterilization wrap or equivalent must be used.
▪ Individual instruments or dedicated Medtronic Transportation/Sterilization Cassettes must be double
wrapped prior to sterilization.
▪ Only instruments manufactured and/or distributed by Medtronic should be included.
▪ Proceed to the STERILIZATION INSTRUCTIONS section.
INSTRUCTIONS - Medtronic Transportation/Sterilization Cassettes Only (cases, trays, lids)
(Instructions for reusable instruments are provided in the previous table)
Bringing new
Medtronic
Transportation/
Sterilization
Cassettes into
service
Point of use
▪ Medtronic Transportation/Sterilization Cassettes are provided non-sterile and must be thoroughly
cleaned, then sterilized before the first use and any reuse.
▪ Remove all packaging material prior to cleaning and sterilization.
▪ Remove all visible soil from case and trays using non-shedding wipes.
▪ Medtronic Transportation/Sterilization Cassettes should be thoroughly cleaned immediately after use to
minimize the potential for drying.
Containment and
transportation
▪ If Medtronic Transportation/Sterilization Cassettes cannot be processed immediately, keep the devices
moist during transport.
▪ Use softened tap water on soiled Medtronic Transportation/Sterilization Cassettes, if available, or cover
with damp towels.
▪ Immediately transport Medtronic Transportation/Sterilization Cassettes to a work area dedicated to
further processing.
Preparation for
cleaning
▪ Medtronic Transportation/Sterilization Cassettes must be cleaned individually and not nested inside one
another. Case and module lids must be removed and cleaned separately or cleaned in the open
position if removal is not applicable.
▪ Medtronic Transportation/Sterilization Cassettes may be safely and effectively processed using manual
or combination manual and automated washer-disinfector (enzymatic only for cases and trays) cleaning
procedures outlined in this document. Do not use alkaline solutions on Medtronic Transportation/
Sterilization Cassettes as these agents cause damage to Medtronic Transportation/Sterilization
Cassettes.
INSTRUCTIONS - Medtronic Transportation/Sterilization Cassettes Only (cases, trays, lids)
(Instructions for reusable instruments are provided in the previous table)
Automated
cleaning:
enzymatic
1. Rinse, flush, and scrub Medtronic Transportation/Sterilization Cassettes under (cold) tap water <110°F
(<43°C) for a minimum of 30 seconds.
2. Transfer the devices to the automated washer-disinfector and program the washer-disinfector with the
cycle parameters listed in Table 3. Ensure Medtronic Transportation/Sterilization Cassettes are
positioned in the washer-disinfector to allow proper drainage. Ensure the inner portions of the
cassettes/modules are angled downward toward the sprayer arms and the cycle parameters in Table 3
are properly programmed.
3. Upon unloading, visually inspect devices, including any lumens and cavities/mated surfaces, to ensure
all visual soil has been removed. If soil is still present, repeat the cleaning process or contact Medtronic
to arrange for disposal or replacement. Do not proceed with processing of a soiled device.
Table 3: Enzymatic (neutral) cleaner (7.0 – 8.0pH)
Cycle Temperature set
points
Pre-wash <110°F (<43°C)
Minimum time
(min:s)
2:00 N/A
Cold tap
Pulsed enzymatic
wash
Wash <140°F (<60°C)
Hot tap
Rinse <140°F (<60°C)
4:00 0.2 – 0.8mL/liter
≥00:15 N/A
Hot tap
Detergent wash
140°F (60°C) 5:00 0.2 – 0.8mL/liter
(neutral pH)
Rinse 160°F (71°C) 5:00 N/A
Thermal rinse
194°F (90°C) 5:00 N/A
(critical water)
Dry 210°F (98.8°C) ≥15:00 N/A
Note: cycle validated using Steris Prolystica Ultra Concentrate Enzymatic Cleaner and Prolystica Neutral
Detergent for washer-disinfector use.
Manual cleaning:
enzymatic
1. Manually clean Medtronic Transportation/Sterilization Cassettes when an automated washerdisinfector is not available.
2. Rinse, flush, and scrub Medtronic Transportation/Sterilization Cassettes under cold tap water <110°F
(<43°C) for a minimum of 1 minute.
3. Scrub devices with appropriately-sized, soft bristle brushes or pipe cleaners to remove visible soil.
Scrub inside any lumens or cavities and actuate device (if applicable).
4. Scrub until all visible soil is removed.
5. Using tap water, prepare an enzymatic cleaning solution according to the manufacturer’s instructions,
dilution recommendations, and temperatures. Place devices in the enzymatic cleaner, submerge
completely, and soak for a minimum of 10 minutes. Ensure all surfaces, lumens, and components are
in contact with the cleaning solution.
6. Remove devices from the enzymatic cleaning solution and flush under running (cold) tap water.
Lumens or cavities must be flushed in the water stream. Rinse with cold tap water for a minimum of 1
minute.
7. Using tap water, prepare a second enzymatic cleaning solution according to the manufacturer’s
instructions, dilution recommendations, and temperatures in an appropriately-sized sonicator.
8. Place the devices in the enzymatic cleaning solution, submerge completely, and ultrasonicate at 40 –
50 kHz for a minimum of 20 minutes.
Note: ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning
solution. Air pockets will decrease the efficacy of the ultrasonic cleaning. Minimize air pockets or bubble
formation by flushing lumens, cavities, crevices, or springs with cleaning solution while the device is
immersed in the ultrasonic tank.
9. Remove devices from the sonicator and rinse using cold running tap water. Lumens or cavities must be
flushed in the water stream. Rinse for a minimum of 10 minutes.
10. Repeat rinsing as in step 9, this time with critical water for an additional 10 minutes.
11. Carefully visually inspect devices, including any lumens and cavities, to ensure all visible soil has been
removed. If any soil is still present, repeat the cleaning process or contact Medtronic immediately to
arrange for disposal or replacement. Do not proceed with processing of a soiled device.
Note: cycle validated using Prolystica Enzymatic Presoak and Cleaner
1
(1 – 4 mL/liter).
Concentration
INSTRUCTIONS - Medtronic Transportation/Sterilization Cassettes Only (cases, trays, lids)
(Instructions for reusable instruments are provided in the previous table)
Drying: Automated Washer-Disinfector
▪ Upon completion of washer-disinfector cycle, perform visual inspection for dryness.
▪ If moisture is observed on Medtronic Transportation/Sterilization Cassettes, dry using clean, absorbent,
non-shedding wipes, and/or forced (medical grade) air until moisture is no longer present.
Manual
▪ Dry the devices using clean, absorbent, non-shedding wipes, and/or forced (medical grade) air. Perform
a visual inspection for dryness and repeat if necessary.
Inspection and
reloading
▪ Inspect Medtronic Transportation/Sterilization Cassettes for damage by performing a thorough
examination as referenced in the EXAMINATION section of this document.
▪ If Medtronic Transportation/Sterilization Cassettes or modules are damaged, contact Medtronic
immediately to arrange for disposal or replacement.
▪ Load the Medtronic Transportation/Sterilization Cassettes or modules with their applicable devices.
▪ Proceed to the STERILIZATION INSTRUCTIONS section.
STERILIZATION INSTRUCTIONS for both Instruments and Medtronic Transportation/Sterilization Cassettes
Sterilization 1. Double wrap individual instruments or double wrap dedicated Medtronic Transportation/Sterilization
Cassettes containing instruments with an FDA-cleared, non-woven/moisture resistant surgical sterilization
wrap.
2. Inspect the packaging to ensure no rips, punctures, or seal failures are present in or on the packaging prior
to loading into the sterilizer.
3. Load the instruments or Medtronic Transportation/Sterilization Cassettes into the sterilizer by following the
sterilizer manufacturer’s recommended loading procedures and load configurations.
Note: do not sterilize stacked Medtronic Transportation/Sterilization Cassettes.
4. Follow the sterilizer manufacturer’s recommended procedures to program the sterilizer with any one of the
sterilization cycle parameters in Table 4.
Table 4: Sterilization cycle parameters
Storage and
Shelf-Life
Cycle Temperature Exposure time
Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Dynamic-air-removal 275°F (135°C) 3 Minutes 30 Minutes
3
Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using
ambient atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s
recommendations.
Chamber size and chamber load differences may exist between industrial and health care facility sterilizer
models. The sterilization parameters in Table 4 can be achieved in both health care facility and larger,
industrial sterilizer models. Because of the many variables involved in sterilization, each health care facility
should calibrate and verify the sterilization process (e.g. temperatures, times) used for their equipment.
The Medtronic Transportation/Sterilization Cassettes may only be used for sterilization. The total weight of
the Medtronic Transportation/Sterilization Cassettes should not exceed 11.4kg/25lbs for the safety of the
personnel handling the Medtronic Transportation/Sterilization Cassettes.
Note: steam for sterilization should be generated from water treated to remove total dissolved solids and
non-condensable gases, filtered to remove contaminates and water droplets, and supplied via piping
without dead legs or other stagnant zones where contamination may collect.
Caution: ethylene oxide (EO), gas plasma, gamma irradiation, chemical vapor, or dry heat sterilization
methods are not recommended for sterilization of these devices. Steam/moist heat is the recommended
method of sterilization.
Ensure the Medtronic Transportation/Sterilization Cassettes are dry before storing. Store in dry, clean
conditions at ambient room temperature. Shelf-life of sterilized Medtronic Transportation/Sterilization Cassettes
is dependent upon the legally marketed sterilization wrap. The health care facility should establish a shelf life
for sterilized instrumentation based upon the type of sterilization wrap used and the recommendations of the
sterile wrap manufacturer.
Minimum dry time
3
STERILIZATION INSTRUCTIONS for both Instruments and Medtronic Transportation/Sterilization Cassettes
Additional
information
▪ Instruments should be processed before being returned to Medtronic.
▪ Immediately clean and re-sterilize the Medtronic Transportation/Sterilization Cassettes used in surgery. The
Medtronic Transportation/Sterilization Cassettes should be thoroughly cleaned, inspected, and sterilized
before being returned to Medtronic.
▪ Any medical device that has been in contact with a patient known to have or suspected to have a prion or
prion-related disease, such as Creutzfeldt - Jakob disease, should not be returned to Medtronic and should
be quarantined and processed per the guidelines in ST79 for processing devices contaminated with high
risk tissue at the health care facility. Contact Medtronic for information regarding proper disposal/
destruction.
The cleaning and sterilization information provided is in accordance with AAMI TIR12, AAMI TIR30, ANSI/AAMI ST81, ISO
17664, ISO 17665, ISO 15883-2, and ISO 15883-5. The processing instructions provided in this document have been validated
as being capable of preparing instruments and Medtronic Transportation/Sterilization Cassettes for reuse. The sterilization
validation demonstrated a sterility assurance level of 10
Transportation/Sterilization Cassettes. A double wrapped, “worst case” perforated tray configuration was used in the validation
activities. The sterilization validation was conducted using an empty chamber load (i.e. using a single worst case transportation/
sterilization cassette).
Sterilization validations for the worst case Medtronic Transportation/Sterilization Cassette (22.75 x 11.26 x 5.5 inches) included
implants and common surgical instruments such as rasps, drivers, trials, handles, inserters, probes, drills, etc. The validated
total weight was 28.4 lbs. The validated worst case loading configurations of the Medtronic Transportation/Sterilization Cassette
included the following worst case lumen dimensions: 363 mm x 1.575 mm and 247.5 mm x 4.1 mm.
The cleaning and sterilization instructions provided have been validated as being capable of preparing the Medtronic
Transportation/Sterilization Cassettes for reuse. The sterilization validation demonstrated a sterility assurance level of 10
sterilization parameters were performed with aluminum Medtronic Transportation/Sterilization Cassettes. It remains the
responsibility of the processor to ensure the processing is performed using validated equipment and that personnel in the
processing facility have been trained to achieve the desired results. This normally requires validation and routine monitoring of
the process. Any deviation by the processor from the instructions should be properly evaluated for effectiveness and potential
adverse consequences. Some devices have specific disassembly/re-assembly instructions. In this case, refer to the instructions
provided with the devices for additional instructions. Users must establish appropriate cleaning protocols for reusable medical
devices used at their sites using the recommendations of the device manufacturer and cleaning agent manufacture.
Device List: Refer to M708348B497E Medtronic Transportation/Sterilization Cassettes IFU at
-6
. The sterilization parameters were validated with Medtronic
www.medtronic.com/manuals.
-6
. The
STORAGE AND SHELF LIFE
Non-sterile instruments and Medtronic Transportation/Sterilization Cassettes: ensure the instruments and Medtronic
Transportation/Sterilization Cassettes are dry before storing. Store in dry, clean conditions at ambient room temperature. Nonsterile instruments and Medtronic Transportation/Sterilization Cassettes are reusable and do not have a specified shelf life. End
of life (shelf life) is determined by excessive wear and damage from normal use. Refer to Limitations on Processing under the
Processing Warning/Cautions section for more information.
Shelf life of sterilized instruments and Medtronic Transportation/Sterilization Cassettes depends on the legally marketed
sterilization wrap. The health care facility should establish a shelf life for sterilized instrumentation based on the type of
sterilization wrap used and the recommendations of the sterile wrap manufacturer.
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
MRI INFORMATION
Medtronic instruments and Transportation/Sterilization Cassettes are not intended to be used in the magnetic resonance (MR)
environment. As such, Medtronic instruments have not been evaluated for safety and compatibility in the MR environment.
Therefore, the safety of the Medtronic instruments in the MR environment is unknown.
FURTHER INFORMATION
If there is any doubt or uncertainty concerning the proper use or processing of Medtronic reusable instruments or Medtronic
Transportation/Sterilization Cassettes, contact Medtronic. In addition, any available surgical techniques will be provided at no
charge.
©2021 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Non-sterile
For US audiences only
Batch code
Manufacturer
Catalogue number
Consult instructions for use at this website.
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