PRESTIGE LP™ Reusable
M708348B183E Rev. C
Instruments
2017-05-12
IMPORTANT INFORMATION FOR THE PRESTIGE LP™ REUSABLE INSTRUMENTS
DESCRIPTION
The PRESTIGE LP™ reusable instruments are made out of a variety of materials commonly used in orthopedic and
neurological procedures which meet available national or international standards specifications.
INTENDED USE
The PRESTIGE LP™ reusable instruments are intended for the surgical implantation of the PRESTIGE LP™ Cervical Disc.
Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
Do not re-use or re-process devices labeled as single use devices. Re-use or re-processing of single use devices may
compromise the structural integrity and the intended function of the device which could result in patient injury.
DO NOT IMPLANT THE INSTRUMENTS.
If there is any doubt or uncertainty concerning the proper use of these instruments, contact Medtronic Customer Service for
instructions. Any available surgical techniques will be provided at no charge.
Medtronic does not and cannot warrant the use of these instruments, 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, such as on sharp edges, may cause injury to the patient or
operative personnel.
▪ Improper maintenance, handling, or poor cleaning procedures can render the instrument unsuitable for its intended
purpose, or even dangerous to the patient or surgical staff.
▪ It is important the surgeon exercise extreme caution when working in close proximity to vital organs, nerves or vessels, and
the forces applied while correcting the position of the instrumentation is not excessive, such that it might cause injury to the
patient.
▪ The methods of use of instruments are to be 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.
▪ Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those
without a previous surgery.
PRECAUTIONS
Any form of distortion or excessive wear on instruments may cause a malfunction likely to lead to serious patient injury.
Regularly review the operational state of all instruments and, if necessary, make use of repair and replacement services.
▪ Do not use this instrument for any action for which it was not intended.
To avoid injury, the instrument should be carefully examined prior to use for functionality or damage prior to use. A
damaged instrument should not be used. Additional back-up instruments should be available.
▪ These instruments should be carefully placed on trays, cleaned after each use, and stored in a dry environment.
▪ Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in the
successful utilization of the system by the surgeon. Further, 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 of the implants or the instruments.
▪ 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.
▪ Some surgeries require the use of instruments which incorporate a measuring function. Ensure these are not worn and any
surface engravings are clearly visible.
POTENTIAL ADVERSE EFFECTS
▪ Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs, or joints.
▪ Infection if instruments are not properly cleaned and sterilized.
▪ Pain, discomfort, or abnormal sensations resulting from the presence of the instrument.
▪ 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 operating staff.
▪ Bony fracture in cases of deformed spine or weak bone.
▪ Tissue damage to the patient, physical injury to operating staff, and/or increased operating time that may result from the
disassembly of multi-component instruments occurring during surgery.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the patient, the important
medical information given in this document should be conveyed to the patient.
FOR US AUDIENCES ONLY
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
These devices should be used only by physicians familiar with the devices, their intended use, any additional
instrumentation, and any available surgical techniques.
PACKAGING
The PRESTIGE LP™ reusable instruments are supplied non-sterile. Packages for non-sterile components should be intact upon
receipt. All sets should be carefully checked for completeness and all components should be carefully checked for signs of
damage prior to use. Damaged packages or products should not be used and should be returned to Medtronic.
Remove all packaging material prior to cleaning and sterilization. Only sterile instruments should be used in surgery.
Instruments should be thoroughly cleaned prior to re-sterilization. Always immediately clean and re-sterilize all instruments used
in surgery. This process must be performed before handling, or before returning product to Medtronic.
EXAMINATION
Instruments must always be examined by the user prior to use in surgery. Examination should be thorough, and should take into
account 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, bruising or distortion, and all components of the
instrument are complete.
Never use instruments with obvious signs of excessive wear, damage, or that are incomplete or otherwise
nonfunctional.
Visual Inspection
Make certain of the following:
▪ Laser etchings, engravings, and other markings are legible.
▪ No cracks are present in instrument handles or any part of the instrument.
▪ Discoloration, stains, or rust do not exist on the instrument. If present, attempt to remove in accordance with the cleaning
instructions provided in the Processing and Reprocessing 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 insulation.
▪ There is no damage to the working ends or tips of the instrument. The working ends should be free of cracks, sharp edged
gouges, and other damage. When applicable, the working ends should be sharp.
▪ There is no damage to threads present on an instrument.
▪ All parts of an instrument are present and free of damage. 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.
Functional Inspection
Make certain of the following:
▪ The parts intended to move will do so 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.
▪ Sharp edges are sharp to the touch and are not dull, have no nicks, or any other damage.
▪ Tips meet when appropriate.
Processing and Reprocessing Instructions - General Considerations
It is the purpose of this document to provide cleaning, disassembly, and sterilization procedures for the PRESTIGE LP™
Reusable Instruments. First, it is important to outline the terminology used in this document and its significance in reprocessing.
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 reprocessing is contingent upon the thoroughness of cleaning.
Cleaning is the initial step and sterilization occurs later in reprocessing. To ensure acceptable reprocessing, there should be no
delay between the steps in this document.
Bloodborne Pathogens
Universal precautions for handling these instruments after use should be observed by all hospital personnel according to OSHA
Standard 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens.
Thorough Cleaning of this Instrument
It is critical that these instruments are thoroughly cleaned after each use following the specific cleaning steps listed in this
document. Ineffective or incomplete cleaning can hinder subsequent sterilization activities.
Automated Cleaning
A fully automated washer/disinfector cycle is not recommended as the sole cleaning method for these instruments. Separate
manual cleaning of each part numbered instrument is required (see Table 1).
TABLE 1
Part Number Component Description
6972425 5mm x 12mm Rail Punch
6972426 6mm x 12mm Rail Punch
6972445 5mm x 14mm Rail Punch
6972446 6mm x 14mm Rail Punch
6972447 7mm x 14mm Rail Punch
6972465 5mm x 16mm Rail Punch
6972466 6mm x 16mm Rail Punch
6972467 7mm x 16mm Rail Punch
6972486 6mm x 18mm Rail Punch
6972487 7mm x 18mm Rail Punch
6972525 5mm x 12mm Trial Cutter Guide
6972526 6mm x 12mm Trial Cutter Guide
6972545 5mm x 14mm Trial Cutter Guide
6972546 6mm x 14mm Trial Cutter Guide
6972547 7mm x 14mm Trial Cutter Guide
6972565 5mm x 16mm Trial Cutter Guide
6972566 6mm x 16mm Trial Cutter Guide
6972567 7mm x 16mm Trial Cutter Guide
6972586 6mm x 18mm Trial Cutter Guide
6972587 7mm x 18mm Trial Cutter Guide
6973000 Inserter Handle
6973050 5mm Inserter Inner Shaft
6973060 6mm Inserter Inner Shaft
6973070 7mm Inserter Inner Shaft
6973225 5mm x 12mm Implant Trial
6973245 5mm x 14mm Implant Trial
6973265 5mm x 16mm Implant Trial
6973226 6mm x 12mm Implant Trial
6973246 6mm x 14mm Implant Trial
6973247 7mm x 14mm Implant Trial
6973266 6mm x 16mm Implant Trial
6973267 7mm x 16mm Implant Trial
6973286 6mm x 18mm Implant Trial
6973287 7mm x 18mm Implant Trial
TABLE 2
Streamlined Instruments
Part Number Component Description
6975405 5mm Rail Punch
6975406 6mm Rail Punch
6975407 7mm Rail Punch
6975205 5mm Drill Guide
6975206 6mm Drill Guide
6975207 7mm Drill Guide
6975225 5mm x 12mm Implant Trial
6975245 5mm x 14mm Implant Trial
6975265 5mm x 16mm Implant Trial
6975226 6mm x 12mm Implant Trial
6975246 6mm x 14mm Implant Trial
6975266 6mm x 16mm Implant Trial
6975286 6mm x 18mm Implant Trial
6975247 7mm x 14mm Implant Trial
6975267 7mm x 16mm Implant Trial
6975287 7mm x 18mm Implant Trial
Manual Cleaning
Disinfection agents such as sanitizing and chemical solutions act to reduce microbes on instrument surfaces, but may not act as
cleaners. Other types of soaps or detergents may not clean this instrument to an appropriate level of cleanliness. Enzymatic
cleaning agents are recommended. This type of cleaner has been shown to effectively remove organic soils, such as blood,
from these instruments. The cleaning instructions for these instruments has been validated by Medtronic using an enzymatic
cleaner.
Cleaning Agents and Cleaning Tools
The following cleaning agents, solutions, or tools should NOT be used when cleaning these instruments:
▪ Saline solution
▪ Alkaline cleaning agents
▪ Solutions containing chlorine (e.g., bleach) or aldehydes (e.g., gluteraldehyde)
▪ Formalin, mercury, chlorides, bromides, iodides, or ringers solution
▪ Metal brushes or scouring pads
The use of neutral pH enzymatic cleaners and soft bristled brushes and soft pipe cleaners are recommended.
Cleaning and Rinsing Water
If available, softened tap water should be used to clean these instruments. De-ionized water should be used for the final rinse
step to prevent mineral deposits on the instrument surfaces.
Use of Mineral Oil or Silicone-Based Lubricants
These types of lubricants should never be used on these instruments as they may not be removed by these cleaning
instructions. The lubricants may coat microorganisms, prevent direct contact of steam with the instrument surfaces, and hinder
sterilization.
MANUAL CLEANING INSTRUCTIONS
Proper Handling After Use
DO NOT allow these instruments 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.
Disassembly Instructions for Instruments Requiring Disassembly Prior to Cleaning
PRESTIGE LP™ Inserter Handle (Part Number 6973000), PRESTIGE LP™ 5mm Inserter Inner Shaft (Part Number 6973050),
PRESTIGE LP™ 6mm Inserter Inner Shaft (Part Number 6973060), and PRESTIGE LP™ 7mm Inserter Inner Shaft (Part
Number 6973070)
1. Separate the Inserter Handle and Inserter Shaft(s) assembled during the surgical procedure. All instruments are required to
be in a stand-alone state prior to the commencement of cleaning (Inserter Inner Shaft(s) disassembled from the Inserter
Handle, see Figure 1).
2. Separate the Inserter Inner Shaft from the Inserter Handle by rotating the square handle counterclockwise. Pull on the head
of the inner shaft every 3 to 4 turns to determine if the threads have disengaged and the inner shaft can now be removed.
3. Proceed with the remaining cleaning instructions in this document.
FIGURE 1
P/N 6973000 Prestige
LP™ Inserter Handle
Prestige LP™
Inserter Inner Shaft
Clean each part number
in its stand-alone state
(non-assembled)
Cleaning Instructions – Point of Use
1. Remove all visible soil from the instrument(s) using non-shedding wipes.
2. Place the instrument(s) in a tray of water or cover with damp towels. Instrument(s) should be cleaned within 30 minutes of
use to minimum the potential for drying.
Cleaning Instructions - Dedicated Cleaning Area
1. Immediately transport the tray containing the covered instrument(s) to a work area dedicated to further reprocessing of
instrument(s).
2. Rinse and flush all instrument parts under running tap water for 3 minutes.
3. Scrub the Inserter Handle, inner lumen of the Inserter Handle, Inserter Shaft, as well as all surfaces of the remaining
instrument(s) with an appropriate soft bristle brush to aid in the removal of visible soil.
4. Perform steps 2 and 3 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 all instrument parts in the enzymatic cleaner, completely submerged, and soak for 45-60 minutes.
7. Remove instrument parts from the enzymatic cleaner and flush under running tap water. Specifically for the PRESTIGE
LP™ Inserter Handle (P/N 6973000), hold it vertically under the water stream in order to flush the inner lumen. Rinse all
instruments for 3 minutes.
8. Using tap water, prepare a second enzymatic cleaning solution according to the manufacturer’s instructions, dilution
recommendation, and temperatures in an appropriately-sized sonicator.
9. Place the instrument parts in the enzymatic cleaner, completely submerged, and sonicate for 45-60 minutes.
10. Remove instrument parts from the sonicator and rinse using running tap water. Specifically for the PRESTIGE LP™ Inserter
Handle (P/N 6973000), hold it vertically under the water stream in order to flush the inner lumen. Rinse all instruments for 3
minutes.
11. Rinse all instruments with de-ionized water for an additional 3 minutes. Specifically for the PRESTIGE LP™ Inserter Handle
(P/N 6973000), hold it vertically under the de-ionized water stream in order to flush the inner lumen.
12. Dry the instrument(s) using clean, absorbent, non-shedding wipes.
13. Carefully inspect the instrument(s), including cannulations and lumens, to ensure all contamination has been removed. Hold
the Inserter Handle up to a light source and inspect the cannulation. If any soil is still present on the instrument(s), repeat
the cleaning process or contact your Medtronic distributor immediately to arrange for disposal or replacement.
NOTE: Do not proceed with reprocessing of a soiled instrument.
14. All instrument(s) should be sterilized separately in a stand-alone, disassembled state.
Inspection
1. Inspect all instruments for deterioration, corrosion, discoloration, pitting, and cracking.
2. If any instrument is damaged in any way, contact your Medtronic distributor immediately to arrange for disposal or
replacement. Do not proceed with reprocessing of a damaged instrument.
Sanitization
The PRESTIGE LP™ instruments listed in Table 1 are considered critical instruments and must be sterilized prior to initial use,
or in adherence to these reprocessing instructions before re-use. Sanitization with disinfectant solutions or chemicals is
unnecessary and not recommended for these instruments.
Sterilization Instructions
Ethylene oxide (EO), gas plasma, gamma irradiation, chemical vapor, or dry heat sterilization methods are NOT recommended
for sterilization of these instruments. Steam/moist heat is the recommended method of sterilization.
These instruments must be sterilized prior to initial use, or as part of these reprocessing instructions, before re-use. It is
recommended to sterilize these instruments as stand-alone instruments.
Sterilization wraps, pouches, chemical indicators, biological indicators, and sterilization trays should be FDA-cleared for the
selected sterilization cycle parameters.
The following sterilization instructions have been validated to a sterility assurance level of 10-6.
1. Wrap or pouch the disassembled instruments separately as stand-alone instruments, or place them into their designated
positions in the PRESTIGE LP™ instrument set tray/case and then wrap the tray/case.
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 instrument into the sterilizer by following the sterilizer manufacturer’s recommended loading procedures and load
configurations.
4. Follow the sterilizer manufacturer’s recommended procedures to program the sterilizer with any one of the sets of
sterilization cycle parameters found in Table 3.
Table 3: Sterilization Cycle Parameters For Medical Facilities Located in the U.S. and Its Territories:
METHOD CYCLE TEMPERATURE EXPOSURE TIME
MINIMUM DRY TIME
1
Steam Gravity Displacement 250°F (121°C) 30 Minutes 30 Minutes
Steam Gravity Displacement 270°F (132°C) 15 Minutes 30 Minutes
Steam Gravity Displacement 275°F (135°C) 10 Minutes 30 Minutes
Steam Dynamic-Air Removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-Air Removal 275°F (135°C) 3 Minutes 30 Minutes
1
The minimum dry times were validated using sterilizers having vacuum drying capabilities. If moisture is observed on the
packaged product at the end of the sterilization cycle, re-packaging and re-sterilization with a longer drying time will be
necessary. Drying cycles using ambient atmospheric pressure will also require longer dry times. Refer to the sterilizer
manufacturer’s recommendations.
NOTE: Chamber size and chamber load differences may exist between industrial and health care facility sterilizer models.
The sterilization parameters listed in Table 2 can be achieved in both health care facility and larger, industrial sterilizer
models. Because of the many variables involved in sterilization, each medical facility should calibrate and verify the
sterilization process (e.g., temperatures, times) used for their equipment.
Although the treatment of the instruments, materials used, and details of sterilization have an important effect, for all practical
purposes, there is no limit to the number of times instruments can be re-sterilized.
Further Information
In case of complaint, or for supplementary information, contact Medtronic.
Product Complaints
Any health care professional (e.g., user of this system of products) having any complaints or having experienced any
dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness, or performance, should notify the
distributor or Medtronic. Further, if any of the implanted spinal system component(s) ever “malfunctions” (i.e., does not meet any
of its performance specifications or otherwise does not perform as intended), or is suspected of doing so, the distributor should
be notified immediately. If any Medtronic product ever malfunctions and may have caused or contributed to the death or serious
injury of a patient, the distributor should be notified immediately by telephone, fax, or written correspondence. When filing a
complaint, provide the component(s) name and number, lot number(s), your name and address, the nature of the complaint,
and notification of whether or not a written report from the distributor is requested.
©2017 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
DESCRIPTION OF DEVICE MARKINGS
CAUTION: Federal law (U.S.A.) restricts this device to sale
by or on the order of a physician.
Consult instructions for use
Batch code
Catalogue number
For U.S. audiences only.
Manufacturer
Non-sterile
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