Vertek II Articulating Arm Instructions for Use Rev C

Contraindications None.

Material composition Material contained in product that can cause an allergic reaction: nickel

Compatibility The Vertek™ II Articulating Arm,Dual Starburst Adapter,and Precision Aiming Device are compatible with Medtronic image-guided surgery systems and Medtronic navigation instruments.

System level manuals These devices can be used with Medtronic image-guided surgical systems. See the StealthStation™ system level manuals and cranial procedure pocket guides for descriptions of patient groups, intended users, clinical benefits, side effects, and potential complications. These devices are accessories to your StealthStation™ system.

Warnings Warning: Prior to use, examine the devices. If you find any damage or deterioration do not use the devices and do not attempt to repair them. Warning: The devices are designed for re-use and are supplied non-sterile. Clean and sterilize them according to the instructions in this package insert before first use and for re-use. Warning: Attach only approved Medtronic Navigation instruments or accessories to the articulating arm. Warning: Once the articulating arm is positioned, take care to avoid jarring it or having other inadvertent contact with it. Warning: Pay attention to instrumentation or drapes touching the arm and avoid any loads, stresses, or contact with the arm that may cause it to slip or deflect. Warning: Use caution and exercise care in order to prevent injury during use. See the corresponding system level manuals and procedure pocket guides for further handling instructions. Warning: Abandon use if damage or malfunction occurs during a procedure. Warning: Abandon use if device sterility is compromised. Warning: Do not attempt to alter the product. Only use the product in accordance with its labeling. Warning: Do not open sterile-barrier packages or containers until surgical use. At time of use, inspect barrier for breach. If the sterile barrier is breached,or if you suspect the device’s sterility has been compormised, reprocess all devices contained in the package. Warning: To avoid potential exposure to blood-borne pathogens and chemicals, use appropriate Personal Protective Equipment when handling, processing, or disposing of Medtronic devices. Warning: Do not re-use or re-process a device where transmissible spongiform encephalopathy agents or Creutzfeldt-Jakob disease contamination is suspected or confirmed. Incinerate the potentially contaminated device according to national guidelines.

Precautions Caution: Federal law (U.S.A) restricts this device to sale by or on the order of a physician. Caution: Refer to the StealthStation™ system level manuals and cranial procedure pocket guides for additional instructions, warnings, and cautions.

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Attachment and positioning Warning: Loosening the locking knob releases tension on all arm joints. Fully support all arm segments whenever you loosen the locking knob, to prevent segments from collapsing and causing injury. Caution: The locking knob has a stop to prevent over-loosening. Do not turn the knob further counterclockwise once it has hit this stop. Turning it further may cause the locking knob to jam. 1. Attach the base starburst of the articulating arm to a matching starburst on the Mayfield clamp or a bed frame holder. Tighten the base attachment screw to secure the arm in place. Note: If you are using two articulating arms, attach a Dual Starburst Adapter (960-535) to the operating room bed frame, and attach an arm to each starburst mount on the Dual Starburst. Note: If using a Sugita Headframe, attach the arm with the Sugita Headframe Adapter (961349). Follow all warnings and cautions in this document. 2. Support the arm with one hand while turning the locking knob counterclockwise to loosen it. Adjust the arm linkage segments into the desired position, and retighten the locking knob. Warning: Tighten the locking knob securely. Carefully confirm that it is sufficiently tightened. Warning: Do not overtighten the knob or use levers, mallets, wrenches, etc. to increase tightening torque. 3. Securely attach a Cranial Reference Frame or other instrumentation to the instrument swivel mount. Warning: If the articulating arm is supporting a patient reference frame, and you suspect any deflection or slippage of the articulating arm after registering the patient, re-register the patient before continuing.

Using the precision aiming device 1. Attach the precision aiming device to the Vertek™ arm. Note: Prior to aiming, make sure the precision aiming device is sufficiently tightened. 2. Align the arm with the precision aiming device attached along the planned surgical trajectory. Note: Make sure that the adjustment screws are not tightened when aiming the Vertek™ arm and precision aiming device. 3. When the precision aiming device is aligned with the planned surgical trajectory, tighten the adjustment screws on the Vertek™ arm so that the precision aiming device cannot move during the procedure. Note: See the procedure pocket guides for detailed instructions on how to use the precision aiming device during supported surgical procedures.

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 Reprocessing

End of useful life is normally determined by wear and damage due to use. See 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.

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Instructions Point of Use

Do not allow blood, debris or bodily fluids to dry on the device. Remove excess soil using running, cold tap water.

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.

Preparation for Cleaning

Automated Cleaning

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. Carefully inspect devices, including any lumens and cavities, to ensure all visible soil is removed. Transfer the devices to the washer and select the instrument cycle. Ensure the following set of cycle parameters are properly programmed. Note: Cycle validated using Steris Prolystica™ 2x Concentrate Enzymatic Cleaner and Steris Prolystica™ 2x Concentrate Neutral Detergent at a concentration of 1.0ml/L (1/8 oz/gal). Phase

Recirculation/Soak (minutes)

Water Temperature

Prewash 1

02:00

Cold tap water N/A

Detergent Type

10 - 16°C (50 - 61°F) Enzyme Wash 02:00

Hot tap water

Neutral pH enzymatic cleaner.

43 - 55°C (109 - 131°F) Wash 1

02:00

66°C (151°F) (setpoint)

Neutral pH detergent

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 00:10 Rinse

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. Drying

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

Maintenance Inspection Testing

Visually inspect the device before each use for obvious damage or corrosion to ensure it is not pitted, fractured, bent, loose, or otherwise damaged. Make sure of the following: • Laser etchings, engravings, and other markings are legible. • No cracks are present in instrument handles or any other part of 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. • All parts are present and free of damage and deterioration. • Mating ends are free of damage (nicks, gouges, bends, etc.) that would interfere with the mating function. 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 this device in a sterilization container with SCF01 paper filters. Caution: The device sterilization tray is to be used only for sterilization, not for cleaning.

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Sterilization

Caution: Device cannot be sterilized to an adequate Sterility Assurance Level without prior cleaning. Use a prevacuum steam sterilization cycle with these parameters to sterilize the device. Sterilization cycle parameters for medical facilities inside the U.S.A. • Temperature: 132°C (270°F) • Exposure Time: 4 minutes (04:00) • Minimum Dry Time: 30 minutes (30:00) Sterilization cycle parameters for medical facilities outside the U.S.A. Option A • Exposure: 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.

Disposal Dispose of contaminated devices according to your facility's biohazard disposal procedure and local and national regulations.

Contact information If a serious incident occurs in relation to the use of this device, report it to Medtronic Navigation. If this 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 the Vertek™ II Articulating Arm or Dual Starburst Adapter, or if you need return shipping instructions, contact your local Medtronic Navigation representative or call 1800 595 9709 or 1 720 890 3160 for technical support.

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

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2022-09 9736376 Revision C ©2022 Medtronic Navigation, Inc. All Rights Reserved

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

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

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