NavLock Tracker Instruments Instructions for Use

9734240: 6.5mm, cannulated

Awl Tip Taps 9734282: 4.0 - 4.5mm 9734283: 4.5 - 5.5mm 9734284: 5.5 - 6.5mm 9734285: 6.5 - 7.5mm

C. Dilators (Tissue Protectors) 9734028: 4.0 - 4.5mm 9734029: 4.5 - 5.5mm 9734030: 5.5 - 6.5mm 9734031: 6.5 - 7.5mm

D. Interbody Trials 9734555: 8mm x 26mm StealthStation™ Capstone™ Trial 9734559: 10mm x 26mm StealthStation™ Capstone™ Trial 9734563: 12mm x 26mm StealthStation™ Capstone™ Trial 9734567: 14mm x 26mm StealthStation™ Capstone™ Trial 9734653: 8mm x 45mm StealthStation™ Clydesdale™ Trial 9734654: 8mm x 50mm StealthStation™ Clydesdale™ Trial 9734655: 8mm x 55mm StealthStation™ Clydesdale™ Trial 9734656: 10mm x 45mm StealthStation™ Clydesdale™ Trial 9734657: 10mm x 50mm StealthStation™ Clydesdale™ Trial 9734658: 10mm x 55mm StealthStation™ Clydesdale™ Trial 9734659: 12mm x 45mm StealthStation™ Clydesdale™ Trial 9734660: 12mm x 50mm StealthStation™ Clydesdale™ Trial 9734661: 12mm x 55mm StealthStation™ Clydesdale™ Trial 9734662: 14mm x 45mm StealthStation™ Clydesdale™ Trial 9734663: 14mm x 50mm StealthStation™ Clydesdale™ Trial 9734664: 14mm x 55mm StealthStation™ Clydesdale™ Trial

E. Slap Hammer 9734592 Slap Hammer

Intended use/Indications for use The Navigated Awls and Probes are intended to be used during pedicle and disc preparation during spinal fusion procedures. The Navigated Taps and Dilators are intended to be used during the preparation for placement of Medtronic screws during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery.

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The navigated instruments are specifically designed for use with Medtronic systems utilizing STEALTH technology that are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Contraindications None.

Material cmposition Material contained in product that can cause an allergic reaction: nickel For additional materials of concern information such as REACH, CA Prop 65, or other product stewardship programs, go to www.medtronic.com/productstewardship.

Compatibility The NavLock™ tracker is compatible with Medtronic image-guided surgery systems and Medtronic navigation instruments.

System level manuals This device can be used with Medtronic image-guided surgery systems. See the system level manuals and spine procedure pocket guides for descriptions of patient target groups, intended users, clinical benefits, side effects, and potential complications disclosure statements. This device is an accessory to your Medtronic system utilizing STEALTH technology.

Warnings Warning: Do not reuse or reprocess the device if transmissible spongiform encephalopathies or Creutzfeldt-Jakob disease contamination is suspected or confirmed. Incinerate the potentially contaminated device according to national guidelines. Warning: Prior to use, examine the devices for damage, deterioration, deformation, and abuse. Do not attempt to use any instrument that appears to be bent or otherwise damaged. Abandon the use of any device damaged during the procedure. See the Maintenance Inspection Testing instructions in this document to determine if the device is suitable for use. If defects are found, do not use the product. Contact Medtronic Navigation. Warning: All NavLock™ Tracker instruments are designed for re-use and are supplied in nonsterile condition. Clean and sterilize the devices before every use according to the directions in this document. Warning: Do not open sterile-barrier packages or containers until surgical use. At time of use, inspect barrier for breach. If the sterile barrier was breached before surgical use, reprocess all devices contained in the package. Warning: During navigation, and after decompression and/or distraction, frequently confirm navigational accuracy by touching the tip of the instrument on known anatomical points, including accuracy checkpoints, and comparing the position of the instrument tip in the image with its physical location. Warning: Exercise care in order to prevent injury when handling instruments. See the system manuals and spine procedure pocket guide for further handling instructions. Warning: Abandon use if damage or malfunction occurs during a procedure. Warning: After initial verification, there is no need to re-verify when switching between instruments.

Precautions Caution: Federal law (U.S.A.) restricts these devices to sale by or on the order of a physician. Caution: Refer to the system level manuals and spine procedure pocket guide for additional instructions, warnings, and cautions.

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Caution: Disengage all components before cleaning and sterilizing. Caution: Cannulated taps have the potential to accumulate bone and other tissue in the cannula. Using a cannulated tap without a guide wire can increase the possibility of bone and tissue accumulation. Please use caution when cleaning the cannula because using sharp instruments to remove material from the obstructed cannula may cause injury to areas of the body including the hand. If the obstruction cannot be removed from the cannula, the device is considered to be at the end of its useful life. Dispose of the device according to national regulations.

Device reprocessing - cleaning, inspection, and sterilization 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 device’s useful 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 and is intended to kill microorganisms to reduce the likelihood of transmission and possibilities of infection. To ensure acceptable reprocessing, there should be no delay between the steps in this document. Blood-borne pathogens - Universal precautions for handling this device after use should be observed by all hospital personnel according to OSHA Standard 29 CFR 1910.1030, Occupational Exposure to Blood borne Pathogens.

Cleaning, inspection, and sterilization Caution: Because of the variability in cleaning efficiencies and sterilizer operating parameters, all given parameters (temperature, time, etc.) 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. Limitations on End of useful life is normally determined by wear and damage due to use. See reprocessing the “Maintenance Inspection Testing” section in this document to determine if the device is at the end of its useful life. Caution: At the end of its useful life, dispose of the device in accordance with national regulations.

Instructions Point of use

Reprocessing begins at the point of use. Cannulated taps have the potential to accumulate bone and other tissue in the cannula. Use without a guide wire can increase this possibility. If the obstruction cannot be removed from the cannula, the device will be considered at the end of its useful life. Dispose of the device according to national regulations. Caution: Do not allow blood, debris, or bodily fluids to dry on the devices. Keep the instruments moist if it cannot be reprocessed immediately.

Containment and transportation

Caution: Devices should be cleaned within 30 minutes of use to limit fixation of contaminants. If the device cannot be reprocessed immediately, keep the device moist during transport. For example, place the device in a tray of tap water. Tap water is defined as utility water with a hardness of <150 mg/l. To prolong the life of the device, reprocess immediately after use.

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Preparation for cleaning

Remove the single-use spheres from the NavLock™ Tracker and dispose of them in accordance with national regulations. No special tools are required; grasp the sphere at its base and pull up. Disengage all components. Before the cleaning step, thoroughly rinse the device under running cold tap water at a temperature of 10-22°C (50-72°F) to remove any visible soil. Use a soft-bristled brush or clean cloth to aid soil removal. Give particular attention to crevices and other areas that present a challenge to cleaning. For cannulated devices, use an appropriately-sized brush, cleaning stylet, or pipe cleaner to clean a 1.50 mm diameter cannula. Carefully inspect devices, including any lumens and cavities, to ensure all visible soil is removed. Caution: If a cannulated instrument is occluded with bone or other tissue, please use caution as injury may occur.

Automated cleaning

Transfer the devices to the washer and select the instrument cycle. Ensure the following set of cycle parameters are properly programmed. Phase

Recirculation/ Soak (minutes)

Water Temperature

Detergent Type

Prewash 1

02:00

Cold tap water

N/A

10-16°C (50-61°F) Enzyme Wash

02:00

Hot tap water 43-55°C (109-131°F)

Prolystica™ 2x Concentrate Enzymatic Cleaner, 1.0ml/L (1/8 oz./gallon), or equivalent neutral pH enzymatic cleaner.

Wash 1

02:00

66°C (151°F) (setpoint)

Prolystica™ 2x Concentrate Neutral Detergent, 1.0ml/L (1/8 oz/gallon), or equivalent neutral pH cleaner.

Rinse 1

00:15

Hot tap water

N/A

43-60°C (109-140°F) Thermal Rinse

01:00

90°C (194°F) (setpoint)

N/A

Purified Water Rinse

00:10

66°C (151°F) (setpoint)

N/A

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

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Manual cleaning Manually clean the device only when a washer-disinfector is not available. Thoroughly rinse device under running cold tap water at a temperature of 10-22°C (50-72°F) to remove visible soil. A soft bristled brush should also be used to aid in the removal of soil. Pay particular attention to crevices and other hard-to-clean areas to remove all visible soil. Prepare neutral enzymatic cleaner Prolystica™ 2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of 1.0ml/L (1/8 oz/gallon) at a temperature of 23-30°C (73-86°F). Immerse the device in the prepared enzymatic cleaner, actuate the device and allow it to soak for a minimum of 10 minutes. Thoroughly clean device with a soft bristle brush for the outer portion of the device. Pay particular attention to crevices, lumens and other hard-to-clean areas to remove all visible soil. For cannulated devices, use an appropriately-sized brush, cleaning stylet, or pipe cleaner to clean a 1.50 mm diameter cannula. After soaking, the device should be thoroughly rinsed under warm running tap water at a temperature of 30-45°C (86-113°F) for a mini-mum of 1 minute to remove all residual cleaner. Allow water into hard-to-reach areas. Prepare neutral enzymatic cleaner Prolystica™ 2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of 1.0ml/L (1/8 oz/gallon) at a temperature of 23-30°C (73-86°F) in a sonication unit. Completely submerge the device in the prepared enzymatic detergent and allow it to sonicate for a minimum of 10 minutes. After sonication, the device should be thoroughly rinsed under warm running tap water at a temperature of 30-45°C (86-113°F) for a mini-mum of 1 minute to remove all residual cleaner. Allow water into hard-to-reach areas. Following the warm tap water rinse, the device should be thoroughly rinsed in room temperature (23-30°C) (73-86°F) de-ionized (DI) water for a minimum of 30 seconds. Warning: After cleaning, visually examine all parts of the device for cleanliness. If visible soil remains, repeat cleaning. Drying

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If necessary, dry the device with a clean, lint-free towel.

Maintenance inspection tiesting

Visually inspect the device before each use for obvious damage or corrosion to ensure it is not pitted, fractured, bent, or otherwise damaged. Make sure of the following: • Laser etchings, engravings, and other markings are legible. • No cracks are present in the instrument. • Discoloration, corrosion, stains or rust are not present. If so, attempt to clean using the cleaning instructions provided in this document. If reprocessing does not remove the corrosion, stains, or rust, the device is at the end of its useful life. • That the handle-to-shaft connection is secure. • There is no damage to the working ends or tips. The working end should be free from cracks, sharp-edged gouges, and other damage. • There is no damage to the threads. • Mating ends are free of damage (nicks, gouges, bends, etc.) that would interfere with the mating function. • Cannulas are free of debris including bone. A device that shows or exhibits properties listed above is at the end of its useful life. Dispose of the device according to national regulations. Warning: Do not reprocess for surgical use a device that has obvious damage or corrosion.

Packaging

Sterilize devices in one of the following configurations: • In the appropriate Medtronic-branded reusable rigid sterilization container with SCF01 paper filters. • In the appropriate Medtronic-branded double-wrapped sterilization tray. • Individually wrapped in sterilization wrap, such as Kimguard™ (KC600) Sterilization Wrap, if the appropriate Medtronic-branded container is not available. Caution: The device sterilization container is to be used for sterilization only, not for cleaning or disinfection. Caution: Do not wrap rigid sterilization containers.

Sterilization

Sterilization cycle parameters for medical facilities inside the U.S.A. • Exposure: Prevacuum • Temperature: 132°C (270°F) • Exposure Time: 4 minutes (04:00) • Minimum Dry Time*: 30 minutes (30:00)

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Sterilization cycle parameters for medical facilities outside the U.S.A. Option A • Exposure Time: Prevacuum • Temperature: 132°C (270°F) • Exposure Time: 4 minutes (04:00) • Minimum Dry Time*: 30 minutes (30:00) Option B • Exposure: Prevacuum • Temperature: 134°C (273°F) • Exposure Time: 18 minutes (18:00) • Minimum Dry Time*: 30 minutes (30:00) * The time required to dry the device may vary with environmental conditions. Note: 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%. Storage

Ensure instruments and sterile packaging are dry before storing. Store in dry, clean conditions at ambient room temperature such that the package is not compromised.

Use 1. Place single-use sterile spheres on each of the four NavLock™ Tracker stems. Push each sphere onto the stem until it “clicks” into place. Make sure the sphere is firmly seated on the stem. 2. Snap the appropriate instrument (example Awl 9734678) into the NavLock™ Tracker until fully seated. Ensure that the instrument cannot be pulled out of the device. 3. Secure the Handle to the hind of the instrument. a. Retract the collar on the handle and snap onto the hind end of the instrument. b. Confirm that the handle is secured to the instrument by making sure that it cannot be pulled out of the device. 4. Verify the assembly. a. Select the current color NavLock™ Tracker from the instrument list in the procedure software ensuring that the default instrument matches the selected instrument. b. Check that the instrument has green status (that it is being tracked by the system) on the screen. c. Place the instrument straight into the reference frame divot. See examples in the illustration below. d. Face the NavLock™ Tracker array toward the camera. e. Wait for the system to verify or press the footswitch to verify (if the system is equipped with a footswitch).

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5. Change instruments as needed. a. Retract the collar on the handle and remove the handle from the instrument. b. Depress the buttons on both sides of the NavLock™ Tracker and remove the instrument from the NavLock tracker. c. Repeat steps 2 and 3 for each instrument. 6. Use the dilators with the Awl Tip Taps. Use tap markings to gauge the depth of the tap as it proceeds beyond the dilator. It is the taps, not the dilators, that are the navigated devices. The dilators should only be used when the NavLock™ Tracker assembly has been verified. 7. Use the Slap Hammer (9734592) to remove trials from the patient anatomy. a. Depress the buttons on both sides of the NavLock™ Tracker and remove the Trial from the NavLock tracker. b. Attach the Slap Hammer to the hind end of the Trial.

Disposal When the device shows visible signs of wear, it is at the end of its useful life. Dispose of it according to your facility's procedure for surgical instruments.

Contact information If a serious incident occurs in relation to the use of this device, report it to Medtronic Navigation. If a serious incident occurs in the European Union, also report it to the competent authority in the Member State where the incident occurred.

Assistance If you have questions about using the NavLock™ Tracker instruments, or need shipping and return information, contact your local Medtronic Navigation representative or call Medtronic Navigation at 1 800 595 9709 or 1 720 890 3200.

Symbol definitions The following symbols may appear on the device packaging: Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Medical device. Importer.

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2021-05 9734290 G04, Revision B ©2021 Medtronic Navigation, Inc. All Rights Reserved

Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Main 1 720 890 3200 Fax 1 720 890 3500 www.medtronic.com Technical Support USA 1 800 595 9709 International 1 720 890 3160 [email protected]

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen Netherlands Telephone 31 45 566 80 00 Australia Medtronic Australasia Pty Ltd 2 Alma Road Macquarie Park, NSW 2113 Telephone 1800 668 670 Printed in the USA

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