Legend and MR8 Navigated 23cm and 31cm attachments and tools Instructions For Use Rev E Oct 2020

Customer service For further information regarding the use of this product or to report any problems, please contact Medtronic Customer Service, or contact your local distributor: Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, Texas 76137 USA US Help Line (800-335-9557) [email protected] International Service: International Customers should contact their local Medtronic representative. The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual. Refer to manuals.medtronic.com for the current version.

The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Legend™, Mazor X™, Midas Rex™, and MR8™. All other trademarks, service marks, registered trademarks or registered service marks are the property of their respective owners in the United States and other countries.

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EN PHYSICIAN NOTE: These attachments and dissecting tools can be used with the Mazor X™ Stealth Edition system. Refer to the Mazor X™ Stealth Edition system instruction manual for additional indications, contraindications, safety precautions, and more detailed instructions for use. Refer to the Midas Rex™ Legend™ or MR8™ system IFUs for more detailed Instructions for use. Refer to Spine procedure guide for more information. Refer to the dissecting tool’s labeling for information on specific operating requirements and limitations.

Device description Attachments Attachments are designed to align the surgical dissecting tools with the motor to provide support and stability during various surgical procedures. Dissecting tools Surgical dissecting tools are designed and intended for the removal and drilling of hard tissue and bone during various surgical procedures.

Indications for use The Midas Rex™ attachments and tools for Mazor are indicated for the incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures. Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

Contraindications None.

Warnings W1

Only use the attachments, instrument tray, and sterilization case after the proper cleaning and sterilization protocols have been followed.

W2

Do not use the twist drill dissecting tools with the 23cm and 31cm attachments outside of the cannula to drill pilot holes.

W3

Do not soak/submerge the attachments.

W4

Dissecting tools are for single use only to prevent contamination. Reprocessing and re-using a dissecting tool may cause injury to the patient. The dissecting tools are packaged sterile and not intended for repeat use.

W5

Drilling with trajectories above the angle limits provided in Table 2 may cause injury to the patient.

W6

Failure to fully lock the attachment and dissecting tool in motor may lead to product detachment and/or patient injury.

W7

Excessive drilling force or applying high lateral force while drilling may result in dissecting tool instability, loss of accuracy, and/or injury to the patient.

W8

Inspect the attachment before and after each use for damage, wear, or illegible markings. If damage is observed, do not use damaged product until it is repaired by Medtronic or replaced.

W9

Using an attachment or dissecting tool that appears unstable may cause loss of accuracy, patient injury, or both.

W10 Using interface products others than those approved for use in this IFU may lead to serious patient injury. W11 Selecting the wrong dissecting tool may cause instrumentation incompatibility, loss of accuracy, or both. Use only dissecting tools specifically designed for use with these drill systems. Match the nomenclature and color on the dissecting tool packaging to the same nomenclature and color band on the attachment. W12 Contact between a rotating dissecting tool and the cannula or other equipment may damage the dissecting tool and may cause dissecting tool instability or loss of accuracy. W13 The dissecting tool performance may be compromised when operated outside of the recommended speeds or pressure settings and may cause patient injury. 1

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W14 Do not use an overheated device as it may cause thermal injury to the patient or operator. W15 All service must be performed by Medtronic qualified personnel only. W16 Do not modify any components of the system; performance could be diminished. W17 Do not place the motor, attachment, or dissecting tool on the patient or in an unsecured location during surgery. W18 Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat reprocessing, starting with the Preparation for cleaning step. W19 Do not wrap the sterilization case. W20 Use the instrument tray and the sterilization case for sterilizing the re-usable devices only. W21 Do not use alkaline cleaning for the instrument tray or the sterilization case. W22 Do not use the instrument tray and the sterilization case for cleaning or disinfecting of the re-usable devices. Devices must be cleaned separate from the tray and case. W23 Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning and decontamination. W24 Dissecting tool flutes are sharp and may perforate surgical gloves. Dissecting tool stems may be grasped with a hemostat to aid in installation and removal. Use methods at the operative site to control bleeding that do not compromise patient safety during surgery. W25 Keep the cutting area of the dissecting tool away from fingers and loose clothing to prevent laceration of the user and crosscontamination through a compromised glove. W26 Do not use a dissecting tool if its packaging is damaged or opened outside the sterile field. Sterility may be compromised if packaging is opened or damaged. W27 Do not use dull dissecting tools. Use of dull dissecting tools can reduce the cutting effectiveness. W28 Exposure of dissecting tool packaging to ambient light for extended periods of time may cause damage to packaging. W29 The drill system operator/user should take appropriate measures in ensuring that sensitive anatomy is protected during drilling and use of the devices. W30 The use of a washer-disinfector for cleaning may cause a degradation in attachment performance. W31 Allow an adequate cooling period after steam sterilization. W32 Do not clean the attachments according to cannula cleaning parameters since this would reduce the useful life of the attachments. W33 The navigated 23cm and 31cm attachments and tools should be used only as an adjunct for surgical guidance. They are not a replacement for the surgeon’s knowledge, expertise, or judgment. W34 Do not apply force when verifying drill assembly. W35 The navigated 23cm and 31cm attachments and tools should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic computerassisted surgery systems. W36 Remove navigation spheres from tracker and discard prior to cleaning and sterilization. W37 Do not operate the device while the tool contacts a divot in the robotic reference frame during navigated tool verification. Operating the device could damage the divot and tool. W38 Operate the Midas Rex™ navigated 23cm and 31cm attachment and tools only after appropriate anatomical landmarks have been identified and the intended surgical site has been confirmed. Refer to the Spine procedure guides and the Mazor X™ Stealth Edition system instructions manual to complete these guidelines.

Cautions C1 C2

2

Do not use an ultrasonic cleaner with automated cleaning. Remove devices from instrument tray before placing into washerdisinfector and allow devices to drain. Orient devices in the washerdisinfector by following manufacturer recommendations.

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C3 C4 C5 C6

C7

C8

C9

C10 C11

C12

Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure. Do not use ultrasonic cleaners for attachments. Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite or bleach, sodium hydroxide, formic acid, or solutions containing glutaraldehyde. Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the dissecting tool from being secured properly in the motor. Do not expose these devices to sterilization temperatures greater than 137°C (279°F). Exposure to temperatures greater than 137°C (279°F) may impact the performance of the device and also the efficacy of the sterilization cycle. Because of the variability in cleaning efficiencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) should be validated by persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility. Devices should be cleaned within 30 minutes (30:00) of use to limit fixation of contaminants. To avoid delays during surgery, setup and confirm instrumentation performance prior to surgery. Having additional sets of instruments and devices is recommended. The tracker is permanently affixed to the attachments and should not be removed at any time.

Training requirements The operator must be familiar with this Instructions for use, Midas Rex™ Legend™ and/or MR8™ Instructions for use, and Mazor X™ Stealth Edition system instruction manual for their precautions, procedures, and safety issues.

Residual risks Residual risks related to the use of a Medtronic Midas Rex™ attachments and dissecting tools for Mazor spine procedures and their associated applications are the same as the residual risks for the spinal procedures in which the system is used. The residual risks are: General surgical complications, insufficient treatment, pain, inflammation, biological reaction, infection, tissue damage/tissue trauma, fractures, vision impairment, burn, bleeding or blood loss, great vessel perforation, cerebrospinal fluid leakage, permanent or transient neurological deficit/ dysfunction, nervous system injury, spinal injury, paralysis, ischemic event, or death.

Possible adverse events In the event that a serious incident has occurred related to device use, immediately report the event to Medtronic and the competent authorities.

Installation Notes: • If any damage, wear, rust, or corrosion is observed with the product or if action is required beyond cleaning, do not use the product and return to Medtronic for service. • Verify functionality prior to use/reuse. - Check attachments for proper appearance, Install the attachment and dissecting tool, then briefly run the motor. - Check attachment for overheating. - Check dissecting tool for flail. Warning: Operate the Midas Rex™ navigated 23cm and 31cm attachment and tools only after appropriate anatomical landmarks have been identified and the intended surgical site has been confirmed. Refer to the Spine procedure guides and the Mazor X™ Stealth Edition system instructions manual to complete these guidelines.

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1. Slide attachment over the motor collet, aligning the triangular arrows on the attachment and the motor case. An audible click, heard and perceptible by touch, confirms that the attachment is fully seated (Figures 1-1 and 1-2). 1-1

Legend™ attachment assembly

1-2

MR8™ attachment assembly

2. Insert the dissecting tool into the attachment with a slight rotational motion (Figures 2-1 and 2-2). An audible click, heard and perceptible by touch, confirms that the dissecting tool is fully seated. 2-1

Legend™ attachment assembly

2-2

MR8™ attachment assembly

3. Rotate the attachment in the direction indicated by arrow on the attachment until the attachment alignment mark is directly in line with the locked symbol (Figures 3-1 and 3-2). You will hear two clicks for the Legend™ and one click with the MR8™ as the attachment is rotated. 3-1

4

Legend™ attachment assembly

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MR8™ attachment assembly

4. Gently pull on the dissecting tool to ensure that it is locked into the assembly. Free run the drill assembly prior to use to check for proper function and dissecting tool stability.

Sterile sphere assembly Open sterile spheres package. Place single-use sterile spheres on each of the tracker’s four posts (Figure 4). Press on each sterile sphere onto the stem until they “snap” into place. Ensure the sterile spheres are firmly seated on the posts, clean and dry before navigating. 4

Sterile sphere assembly

Navigation Once the sterile spheres are assembled, the product can be optically tracked by the Mazor X™ Stealth Edition system. Refer to the Mazor X™ Stealth Edition system instruction manual for further instructions on selection of instrument tool cards, navigation, and troubleshooting instructions of the navigated instrument.

Navigated tool verification Warning: Do not operate the device while the tool contacts a divot in the robotic reference frame during navigated tool verification. Operating the device could damage the divot and tool. Place the tip of each instrument into a divot in the robotic reference frame (Figure 5). Hold the instrument perpendicular and visible to the navigation camera until confirmation is received. Refer to the Mazor X™ Stealth Edition system instruction manual for further instructions on verification of the navigated device. 5

Navigated tool verification

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Drilling The navigated 23cm and 31cm attachments and tools are used with the Mazor X™ Stealth Edition system to create pilot holes. Refer to Table 1 for platform, attachment, dissecting tool, and cannula compatibility. Note: For drilling multiple pilot holes, clean the debris from the drill assembly prior to insertion into the cannula. Table 1: Attachment and dissecting tool compatibility with cannula Platform

Attachment

Dissecting tool

Cannula

Hole diameter

RBT024101 AS23N

23TD3030

RBT024501 RBT034201

3.0mm

RBT034501

Legend™

RBT024102 AS31N

31TD3030

RBT024502 RBT034202

3.0mm

RBT034502 RBT024101 MR8-AS23N

MR8-23TD3030

RBT024501 RBT034201

3.0mm

RBT034501

MR8™

RBT024102 MR8-AS31N

MR8-31TD3030

RBT024502 RBT034202

3.0mm

RBT034502

Note: Confirm the color on the navigated attachment matches the color on the tool pouch. Refer to the system IFU for tool nomenclature. After installation, sterile sphere assembly, and navigated tool verification, prepare for drilling with the following steps: 1. Power the drill assembly per the following: (1) For electric motors: set the Integrated Power Console (IPC) speed between 60,000 RPM to 75,000 RPM (2) For pneumatic motors: set the pneumatic foot (PCU) control pressure between 80 psi to 120 psi 2. Insert the drill assembly inside the cannula. Raise the drill assembly slightly off the bone. 3. Power the drill assembly and provide a slight forward drilling force until the tip of the attachment comes into contact with the bone structure. After creating the pilot hole, back the drill assembly out while running the motor until the drill reaches the original starting point. Note: Take note of depth markings on the attachment to ensure the dissecting tool is removed from the pilot hole before stopping the drill. 4. Stop the motor before removing the drill assembly from the cannula. Caution: Do not run the drill while removing the dissecting tool and attachment from the cannula. 5. Clean debris from cannula and from the drill assembly (including the dissecting tool tip). 6. For drilling multiple pilot holes, clean the debris from the drill assembly prior to insertion into the cannula and after removing the drill assembly from the cannula. Ensure the drill assembly and cannula do not have debris on them.

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Drill angle limitations Warnings: Drilling with trajectories above the angle limits provided in Table 2 may cause injury to the patient. Table 2: Drill angle limits Platform

Dissecting tool

Drill angle limit

23TD3030 Legend™ 31TD3030 60° MR8™-23TD3030 MR8™ MR8™-31TD3030

Removal 1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position. In this position, the arrows on the attachment and motor will line up. 2. Remove the dissecting tool from the attachment and discard the dissecting tool per local regulations. 3. Use thumb and index finger to lift the attachment off of the motor. 4. Remove all the spheres from tracker and discard the spheres per local regulations.

Sterility The dissecting tools and navigation spheres are provided STERILE by use of radiation and are intended for SINGLE PATIENT USE ONLY. DO NOT RESTERILIZE THE DISSECTING TOOLS. MEDTRONIC ASSUMES NO LIABILITY FOR DEVICES THAT HAVE BEEN RESTERILZED BY HEALTH CARE FACILITIES. Attachments are REUSABLE and provided NON-STERILE.

System accessories: disposable components Cleaning brushes Clean debris from lumen of attachments with the appropriate cleaning brushes. The disposable cleaning brushes are sized for navigated 23cm and 31cm attachments. Table 3: Disposable cleaning brush dimensions Internal bore diameter

Brush length

3.2 mm

41 cm (16 in)

System accessories: non-disposable components Instrument trays The 3/4 DIN MAZ600 instrument tray (Figures 6-1 through 6-3) holds the navigated 23cm and 31cm attachments and cannulas to be sterilized and the instrument tray is placed inside the sterilization case or wrapped for steam sterilization. 6-1

Instrument tray closed 3/4 DIN MAZ600

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3/4 DIN MAZ600 instrument tray upper level with cannulas

6-3

3/4 DIN MAZ600 instrument tray lower level with attachments

Sterilization case The sterilization case (Figure 7) is a sterilization containment device designed to hold the cannula and attachments for sterilization, storage, transportation, and aseptic presentation of its contents. This case is available in 3/4 DIN. The sterilization case consists of a base with carrying handles and a lid that is secured to the base by means of a latching mechanism. The instrument tray holds the attachments and cannulas to be sterilized and is placed inside the sterilization case. A filter system is incorporated to provide for air evacuation and sterilant penetration during the sterilization cycle and to act as a barrier to microorganisms during storage, handling, and transport. 7

8

3/4 DIN sterilization case

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Cleaning and sterilization Attachments should be cleaned and then sterilized per the instructions below: Note: Reprocess the cannula per the instructions in the Medtronic Surgical Instruments for use with Mazor X™ Stealth Edition (M708348B825E) and Medtronic Reusable Instruments and Accessories (0380035). Medtronic recommends incineration of devices that have directly contacted patients suspected or confirmed with a Transmissible Spongiform Encephalopathy (TSE)/ Creutzfeldt-Jakob disease (CJD) diagnosis. Reprocessing instructions for the cannulas Follow the reprocessing instructions for Medtronic Surgical Instruments for use with Mazor X™ Stealth Edition (M708348B825E) and Medtronic Reusable Instruments and Accessories (0380035).

Reprocessing instructions for the navigated attachments, instrument tray, and sterilization case Warnings and cautions

•

Do not clean the attachments according to cannula cleaning parameters since this would reduce the useful life of the attachment.

•

Do not remove the tracker. Removal of tracker could damage navigated attachment.

•

Remove navigation spheres from tracker and discard prior to cleaning and sterilization.

•

Do not soak/submerge devices.

•

The use of a washer-disinfector for cleaning may cause a degradation in performance.

•

Allow an adequate cooling period after steam sterilization.

•

Do not use ultrasonic cleaners to clean devices.

•

Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite or bleach, sodium hydroxide, formic acid, or solutions containing glutaraldehyde.

•

Limitations on reprocessing Point of use

Containment and transportation Preparation for decontamination Preparation for cleaning

Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the dissecting tool from being secured properly in the handpiece. The product is provided non-sterile and must be cleaned and sterilized before first use and any reuse. Reprocessing begins at the point of use. Reprocess the device within 30 minutes of use. Do not allow blood, debris, or bodily fluids to dry on the device. Remove excess soil using running, cold tap water 10 - 22°C (50 - 72°F). Tap water is defined as potable water with a hardness value of <150 mg/L. It is recommended that devices are reprocessed as soon as is practical following use. Detach the attachment from the motor. Remove and discard the dissecting tool. Do not soak devices. Attachments: •

Ensure that the motor, dissecting tool, and navigation spheres have been removed from the attachment prior to cleaning.

•

Manually rinse the attachment under tap water, ensuring all hard to reach areas are rinsed, until no visible soil is noticed.

•

Use a nylon brush to aid in cleaning.

•

Give attention to crevices and other areas that present a challenge to cleaning.

•

Remove devices from instrument trays before placing into washer, if applicable.

•

Orient devices following recommendations of the washerdisinfector manufacturer.

•

Clean per recommended washer cycles for neutral or alkaline washer cycle parameters in either Table 4 or Table 5.

•

After cleaning, visually examine all parts of the device for cleanliness. If visible soil remains, repeat cleaning.

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Reprocessing instructions for the navigated attachments, instrument tray, and sterilization case Instrument tray: •

To clean the instrument tray after use, thoroughly rinse the instrument tray under cold running tap water to remove any visible soil.

•

Use a soft-bristled brush or clean cloth to aid soil removal around brackets and handles.

•

Give particular attention to crevices and other areas that present a challenge to cleaning.

•

Carefully inspect trays, handles, instrument brackets, and cavities to ensure all visible soil is removed.

•

Clean per recommended washer cycle per neutral wash cycle parameters in Table 4.

•

After cleaning per the recommended washer cycle below, visually examine the instrument tray for cleanliness. If visible soil remains, repeat cleaning.

Sterilization case: •

To clean the sterilization case after use, discard the single use filters and thoroughly rinse the sterilization case under cold running tap water to remove any visible soil.

•

Use a soft-bristled brush or clean cloth to aid soil removal around brackets, filter retention plates, and handles.

•

Gently flush the gasket region of the sterilization case if soil is visible.

•

Give particular attention to crevices and other areas that present a challenge to cleaning.

•

Carefully inspect cases, handles, gaskets, filter retention plates, instrument brackets, and cavities to ensure all visible soil is removed.

•

Remove the filter retention plates from the lid and base by turning the lever on the retention plate clockwise. Do not remove the gasket for the cleaning procedure.

•

Clean per recommended washer cycle per neutral wash cycle parameters in Table 4.

•

After cleaning per the recommended washer cycle below, visually examine the sterilization case for cleanliness. If visible soil remains, repeat cleaning.

Cleaning: Automated Warnings: •

Use the instrument tray and the sterilization case for sterilizing the re-usable devices only.

•

Do not use the instrument tray and sterilization case for cleaning or disinfection of the re-usable devices.

•

Do not use ultrasonic cleaner.

Table 4: Automated wash cycle using a neutral enzymatic detergent (pH 6.0-8.0) Phase Pre-wash

Recirculation (minutes) 2 minutes (02:00)

Water temperature Cold tap water 10 - 16°C (50 - 61°F) Hot tap water 43 - 55°C (109 - 131°F)

Enzyme wash

2 minutes (02:00)

Wash

2 minutes (02:00)

66°C (155°F) (setpoint)

Rinse

15 seconds (00:15) 1 minute (01:00) 10 seconds (00:10)

43 - 60°C (109 - 140°F) 90°C (194°F) (setpoint) 66°C (151°F) (setpoint)

Thermal rinse Purified water rinse

If visible soil remains, repeat cleaning.

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Detergent type Not applicable

Neutral pH enzymatic cleaner like STERIS Prolystica® 2x concentrate enzymatic cleaner, 1.0mL/L (1/8 oz/gallon) (diluted pH range of 6.0 - 8.0) Neutral pH detergent like STERIS Prolystica®2x concentrate neutral detergent, 1.0mL/L (1/8 oz/gallon) (diluted pH range of 6.0 - 8.0) Not applicable Not applicable Not applicable

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Reprocessing instructions for the navigated attachments, instrument tray, and sterilization case Table 5: Automated wash cycle using an alkaline detergent Note: Do not use alkaline cleaning for the instrument tray or the sterilization case. Recirculation (minutes)

Water temperature

Pre-wash

2 minutes (02:00)

Wash

5 minutes (05:00)

Cold tap water 10 - 16°C (50 - 61°F) 43°C (109°F) (setpoint)

Rinse

1 minute (01:00)

Phase

Thermal rinse

Hot tap water 43 - 60°C (109 - 140°F) 90°C (194°F) (setpoint) 66°C (151°F) (setpoint)

1 minute (01:00) Purified water 1 minute, rinse 30 seconds (01:30) If visible soil remains, repeat cleaning.

Detergent type Not applicable

Alkaline detergent like Dr. Weigert neodisher SeptoClean, 3mL/L (3/8 oz/gal) (diluted pH range of 11.0 - 11.2) Not applicable

Not applicable Not applicable

*Alkaline detergent manufacturers provide alkaline detergents concentrated. The alkaline detergents must be diluted per the detergent manufacturer’s instructions for cleaning medical devices. Medtronic has verified alkaline detergent compatibility for working solutions up to 11.2. Cleaning: Manual

Navigated attachments: 1.

Ensure that the motor, dissecting tool, and navigation spheres have been removed from the attachment prior to cleaning.

2.

Thoroughly rinse the attachment under tap water, ensuring all hard to reach areas are rinsed, until no visible soil is noticed.

3.

Use a nylon brush to aid in cleaning.

4.

Give attention to crevices and other areas that present a challenge to cleaning.

5.

Prepare with tap water an enzymatic cleaner, like STERIS Prolystica® 2x concentrate enzymatic cleaner, following the manufacturer’s recommendations of 1.0 mL/L (1/8 oz/ gallon) at room temperature or use an equivalent neutral pH cleaner following that manufacturer’s recommendations.

6.

Thoroughly wipe all attachments with a cloth, dampened with a surgical instrument cleaning solution until all gross soil has been removed.

7.

Using a brush wetted with the detergent, brush the attachments to clean the external surfaces and internal connecting surfaces.

8.

Attachments have special cleaning brushes sized to the attachment’s internal diameter. Push the brush, wet with surgical instrument cleaning solution, through the attachment from rear to front to loosen and remove debris trapped inside. Insert the brush into the bore at the front of the attachment. Brush the bore to loosen debris trapped inside. Rinse the bore to remove debris.

9.

10. Rinse the attachment thoroughly with tap water. Flush both ends to remove detergent. 11. Following the warm tap water rinse, the attachment should be thoroughly rinsed in room temperature with purified water (deionized, reverse osmosis, or equivalent) for a minimum of 30 seconds. 12. Verify that devices are visually clean after manual cleaning. If visible soil remains, repeat cleaning. 13. Thoroughly dry attachments. An air gun may be used to blow moisture out.

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Reprocessing instructions for the navigated attachments, instrument tray, and sterilization case Instrument tray and sterilization case: 1. Manually clean the sterilization case and instrument tray only when a washer-disinfector is not available. 1.

Thoroughly rinse the sterilization case and instrument tray under cold running tap water (10 - 22°C/50 - 72°F) to remove any visible soil.

2.

Use a soft-bristled brush or clean cloth to aid soil removal around brackets, handles, and filter retention plates (only on the sterilization case).

3.

If soil is visible, gently flush the gasket region of the sterilization case.

4.

Give particular attention to crevices and other areas that present a challenge to cleaning.

5.

Carefully inspect the sterilization case and instrument tray, including the handles, gaskets, filter retention plates, and cavities, to ensure all visible soil is removed.

2. Prepare neutral enzymatic cleaner STERIS Prolystica®2x concentrate. 1.

Prepare the enzymatic cleaner following the manufacturer’s recommendations of 1.0ml/L (1/8 oz/gallon) at a temperature of 23°C (73°F) or use an equivalent neutral pH cleaner following that manufacturer’s recommendations.

2.

Immerse the sterilization case and instrument tray in the prepared enzymatic cleaner, actuate the tray and allow it to soak for a minimum of 10 minutes.

3. Thoroughly clean the sterilization case and instrument tray. 1.

Use a soft-bristled brush for the outer portion of the sterilization case and instrument tray.

2.

Pay particular attention to crevices, filter retention plates (only on the sterilization case), latches, and other hard-to-clean areas to remove all visible soil. 4. After soaking, thoroughly rinse the sterilization case and instrument tray under warm (23 - 43°C/73 - 109°F) running tap water for a minimum of 1 minute to remove all residual cleaner. 1.

Rinse the sterilization case and instrument tray.

2.

Use a syringe to aid in rinsing.

5. Following the warm tap water rinse, thoroughly rinse the sterilization case and instrument tray in room temperature 25°C (77°F) purified water (deionized, reverse osmosis, or equivalent) water for a minimum of 30 seconds. Note: After cleaning, visually examine all parts of the sterilization case and instrument tray for cleanliness. If visible soil remains, repeat cleaning.

Drying and lubrication

6. Dry the instrument tray and sterilization case with a clean, lint-free towel. Note: Medtronic no longer recommends using the Legend™ navigated attachment cleaning nozzle (PA120), as this may cause some navigated attachments to overheat. Thoroughly dry navigated attachments. An air gun may be used to blow moisture out from rear to front of navigated attachment. Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate the navigated attachment. 1. Holding the can approximately 10-15cm (3-6 in.) away from the navigated attachment, spray all components that move, rotate, or slide with three quick squirts.

Disinfection Maintenance, inspection, and testing

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2. Remove excess lubricant with a clean cloth. No particular requirements. Do not reprocess for surgical use a device that has obvious damage or corrosion. Return to Medtronic for service. Visually inspect the reprocessed devices following cleaning. Inspection should be performed with adequate lighting. Magnification is not required. A device that shows or exhibits the properties listed below is at the end of its useful life. Attachments may be disposed of at the end of their useful life according to local and national regulations. •

Obvious damage or corrosion

•

Pitting, cracks, fractures, or bending

•

Illegible laser etchings, engravings, and other markings

•

Discoloration, corrosion, stains or rust

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Reprocessing instructions for the navigated attachments, instrument tray, and sterilization case Packaging

Warnings: •

Do not wrap the sterilization case.

•

Use the instrument tray and the sterilization case for sterilization only. The attachments and cannulas must be cleaned separate from the trays.

There are two options available for packaging: 1. Devices may be sterilized using a wrapped instrument tray. The instrument tray should be wrapped with two layers of 1-ply polypropylene wrap using a sequential envelope technique. For use in the USA, an FDA-cleared wrap should be used. 2. Devices can also be sterilized by placing them inside the instrument tray and then placing the instrument tray inside the sterilization case. Instrument tray: 1. Inspect the devices before each sterilization cycle. Make sure the instrument tray does not have cracks or tears and that the silicone brackets are not damaged. 2. Arrange the cleaned devices in the instrument tray’s silicone brackets. The instrument tray includes printed outlines as a guide for the devices that fit within the tray. 3. Close the instrument tray with the lid. Option 1: Wrap the instrument tray for sterilization: •

The user facility is responsible for using only accessories (such as sterilization wraps, chemical indicators, and biological indicators) that are cleared and labeled for the validated sterilization parameters specified in this Instructions for Use by the Food and Drug Administration for medical facilities in the U.S.A. and its territories, or conform to EN ISO 11607 for medical facilities outside of the U.S.A. and its territories.

•

The instrument tray should be wrapped with two layers of 1-ply polypropylene wrap using a sequential envelope technique. For use in the USA, an FDA-cleared wrap should be used.

Option 2: Place the instrument tray into the sterilization case: 1. Use one filter for the sterilization case’s lid. 1.

Place the filter over the perforations in the lid and place a filter retention plate over the filter.

2.

Secure the filter retention plate by pushing downwards at the center and rotating the handles until you hear them click (Figure 8-1).

2. Place a rack around the filter plates (Figure 8-2). 3. Place the instrument tray with the lid on into the sterilization case (Figure 8-3). 4. Close the sterilization case and apply labels and seals. 1.

On both sides of the sterilization case, position the top of the latch over the ridge in the lid and push the bottom section of the latch in toward the sterilization case (Figure 8-4). You will feel a solid click.

2.

Place the appropriate metal ID tags in the label holders located on either side of the sterilization case latches (Figure 8-5).

Note: Use only the approved tamper-evident seals. Using a nonapproved tamper-evident seal could damage the locking clip. 5. Place the case flat on the shelf of the sterilizer cart.

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Reprocessing instructions for the navigated attachments, instrument tray, and sterilization case 8-1

Sterilization case filter placement

8-2

3/4 DIN sterilization case with rack

8-3

Instrument tray inside the sterilization case

8-4

3/4 DIN closed case

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Reprocessing instructions for the navigated attachments, instrument tray, and sterilization case 8-5

Sterilization

Tamper-evident seal on the 3/4 DIN case

Warnings: •

Do not attempt to run the attachments immediately after autoclaving. Allow an adequate cooling period after steam sterilization.

•

Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat reprocessing, starting with the Preparation for cleaning step.

•

Use the instrument tray and the sterilization case for sterilization only. The system devices must be cleaned separate from the trays.

•

Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning and decontamination.

Cautions: •

Do not expose these devices to sterilization temperatures greater than 137°C (279°F). Exposure to temperatures greater than 137°C (279°F) may impact the performance of the device and also the efficacy of the sterilization cycle.

Notes: •

The instructions provided have been validated by the manufacturer as being capable of preparing the product for reuse. It remains the responsibility of the processor to ensure that the reprocessing as actually performed, using equipment, materials, and personnel in the reprocessing facility, achieves the desired result. This normally requires validation and routine monitoring of the process.

•

Load the parts into the sterilizer by following the sterilizer manufacturer’s recommended loading procedures and load configurations.

•

These sterilization instructions have been validated to a sterility assurance level of 10-6.

•

The recommended sterilization parameters are only valid with properly maintained and calibrated equipment that is cleared by the Food and Drug Administration for medical facilities in the U.S.A. and its territories or CE marked for medical facilities outside the U.S.A. and its territories.

•

Steam for sterilization should be generated from water that has been treated to remove total dissolved solids, filtered to remove contaminants and water droplets, and supplied via piping without deadlegs or other stagnant zones where contamination might collect. Steam saturation should be greater than 97%.

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Reprocessing instructions for the navigated attachments, instrument tray, and sterilization case Cycle

Temperature

Minimum Exposure time dry time (wrapped)

Minimum dry time (sterilization case)

In any geography - sterilization prevacuum (dynamic-air-removal) steam cycle parameters for medical facilities Prevacuum

132°C (270°F)

4 minutes (04:00)

35 minutes (35:00)*

30 minutes (30:00)*

Prevacuum

135°C (275°F)

3 minutes (03:00)

35 minutes (35:00)*

30 minutes (30:00)*

Outside the U.S.A. - sterilization prevacuum (dynamic-air-removal) steam cycle parameters for medical facilities Prevacuum

134°C (273°F)

3 minutes (03:00)

35 minutes (35:00)*

30 minutes (30:00)*

Prevacuum

134°C (273°F)

18 minutes (18:00)

35 minutes (35:00)*

30 minutes (30:00)*

*Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient atmospheric pressures may require more time. Maintenance, inspection, and testing

Storage

Use

Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired. Verify functionality prior to use/reuse. •

Check attachments for proper appearance, Install the attachment and dissecting tool, then briefly run the motor.

•

Check attachment for overheating.

• Check dissecting tool for flail. Make sure that the case is dry before storage and stored in cool, dry conditions at ambient room temperature. Store sterile devices in such a way that the sterile package is not compromised. When you are ready to use the devices, follow these steps. 1. Before you open the case, make sure that: (1) You have selected the correct sterilization case. (2) The tamper-evident seals are intact. 2. Unlatch the case. 3. Use the ring on top of the lid to remove the lid. Using the ring avoids contaminating the case’s contents. 4. Remove the tray of devices and place it in the sterile field.

Disposal After use, dispose of the device in accordance with hospital, administrative, or government policies.

Customer service For further information regarding the use of this product or to report any problems, please contact Medtronic using the appropriate information provided on the contact information card packaged with each device; or contact your local distributor.

Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE) Attachments that have been used on patients with suspected CreutzfeldtJakob Disease (CJD) or other Transmissible Spongiform Encephalopathies (TSE) should be quarantined and not reused until a diagnosis is confirmed or excluded. Medtronic Powered Surgical Solutions (MPSS) will not authorize or accept the return of MPSS products that directly contacted a patient or are contaminated with a patient’s body fluids that is suspected or confirmed with TSE or CJD diagnosis. Furthermore, MPSS recommends that all MPSS product used on a patient confirmed with or suspected of a TSE/CJD diagnosis be incinerated. If TSE/CJD is excluded as a diagnosis, the quarantined reusuable equipment may be returned for use after appropriate cleaning, decontamination and sterilization. Hospital personnel should contact their infection control personnel for current procedures and policy for reusable equipment processing. Contact your Sales Representative for temporary equipment while original equipment is quarantined or for replacement of

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product incinerated under this policy.

Planned maintenance For the planned maintenance schedule, the Midas Rex™ Legend™ or MR8™ high speed drill system Instructions for use will assist you in getting the greatest ownership value from your system, while helping to maximize its performance, safety, and reliability. The scheduled preventative maintenance/service program is in addition to the required routine cleaning after each use. Please refer to the planned maintenance section of the Midas Rex™ Legend™ or MR8™ high speed drill system Instructions for use for the specific steps necessary to maintain the device performance.

Limited warranty For limited warranty information, see the Legend or MR8 system Instructions for use.

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Symbols Compliant with European Council Directive MDD 93/42/EEC

EC REP Authorized Representative in the European Community Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Consult Instructions for use

Manufacturer

Use By Date

Catalog Number

Use With

Locked

Do not use if package is damaged

Package Quantity

Non-sterile

Sterilized using Irradiation

Serial Number

Attachment

Lot Number

Diameter

Dissecting Tool

Single Use

Medical Device

Single Sterile Barrier

Distributor

Importer

Quantity