Simplify Disc Instruments Instructions for Use

Instruments are provided non-sterile and must be cleaned and sterilized using the validated instructions prior to use.

Recommendations for Care and Cleaning of Simplify Disc Instruments Set Initial Treatment at Point of Use Promptly after use, rinse instruments under running tap water (≈45°C) to remove gross soil. It is suggested to keep instruments moist after point of use (i.e., soak in treated water or cover with damp towels) until the manual cleaning process is initiated. Preparation before cleaning Perform manual or automated cleaning using the following: • Advanced Sterilization Products Enzol Enzymatic Detergent for Manual Cleaning or neodisher MediClean forte for Automated Cleaning with Manual Pre-Cleaning • Non-abrasive, nylon bristled brush (Sklar #10-1444 Double End Brush Nylon or equivalent) • ISO 15883-1 compliant washer disinfector

2

Manual Cleaning The following Manual Cleaning Instructions have been validated. 1

Prepare detergent solution using Enzol Enzymatic detergent (Advanced Sterilization Products, Division of Ethicon US, LLP), two (2) ounces (60 mL) of detergent per one gallon (3.8 L) of tap water (22°C to 27°C).

2

If applicable, fully extend the jaws of the device.

3

Rinse device under running tap water (22°C to 27°C) for a minimum of 30 seconds.

4

Immerse device in detergent solution and (if applicable) fully actuate the shaft in, then out while submerged.

5

Soak devices in detergent for two (2) minutes.

6

Brush the threaded area of the device for one (1) minute and all remaining surfaces of the device for one (1) minute [for a total of two (2) minutes of brushing] using a non-abrasive nylon bristled brush (Sklar #10-1444 Double End Brush Nylon or equivalent).

7

Flush lumen(s) (if applicable) of device six (6) times with 50 mL aliquots of detergent solution (300 mL total).

8

Sonicate devices for five (5) minutes in detergent.

9

Remove devices from sonicator and rinse under running tap water for one (1) minute. If applicable, actuate shaft in and out while rinsing.

10

If applicable, flush lumen six (6) times with 50 mL aliquots of tap water (300 mL total).

11

Submerge device in de-ionized (DI) water for 1 minute.

12

Wipe device with non-linting wipe(s) and allow to dry completely.

13

Visually inspect each instrument for the absence or presence of remaining soil in a well-lit area.

Automated Cleaning (with Manual Pre-Cleaning) The following Automated Cleaning procedure (with Manual Pre-Cleaning) has been validated. Manual Pre-Cleaning 1

Prepare a detergent solution using neodisherMediClean forte prepared using 5 mL detergent per liter of water (0.5%).

2

If applicable, fully extend the jaws of the device.

3

Rinse device under running tap water (22°C to 27°C) for a minimum of 30 seconds.

4

Immerse device in detergent solution and (if applicable) fully actuate the shaft in, then out while submerged.

5

Soak devices in detergent for two (2) minutes.

6

Brush the threaded area of the device for one (1) minute and all remaining surfaces of the device for one (1) minute [for a total of two (2) minutes of brushing] using a non-abrasive nylon bristled brush (Sklar #10-1444 Double End Brush Nylon).

7

Flush lumen(s) (if applicable) of device six (6) times with 50 mL aliquots of detergent solution (300 mL total).

8

If applicable, flush lumen six (6) times with 50 mL aliquots of tap water (300 mL total).

9

Wipe device with non-linting wipe(s) and allow to dry completely.

3

Automated Cleaning and Disinfection (with Manual Pre-Cleaning) 1 2 3

Before automated cleaning, devices must be cleaned in accordance with the Manual Pre-Cleaning. Place the instruments in a washer-disinfector at an angle to allow for draining and ensure device cavities are facing down. Perform the following automated cycle: Pre-Wash

RECIRCULATION TIME (MINUTES : SECONDS) 02:00

Wash

10:00

Rinse

0:15

Thermal Rinse

05:00

Drying

15:00

PHASE

TEMPERATURE Cold Heated 140°F / 60.0°C Hot Heated 194°F / 90.0°C 210°F / 98.8°C (High)

DETERGENT / WATER TYPE Tap neodisher MediClean forte (5 mL per L water) Tap High Purity N/A

4

If needed, thoroughly dry the instrument with a clean, lint-free cloth/wipe. Use filtered, medical grade, pressurized air (≤40psi) or a syringe filled with air to facilitate drying the device.

5

Visually inspect each instrument for the absence or presence of remaining soil in a well-lit area.

Recommendations for Care and Cleaning of Simplify Disc Tray Initial Treatment at Point of Use It is suggested to keep the tray moist after point of use (i.e., soak in treated water or cover with damp towels) until the manual cleaning process is initiated. Preparation before cleaning Perform automated cleaning using the following: • neodisher MediClean forte Detergent • Non-abrasive, nylon bristled brush (Sklar #10-1444 Double End Brush Nylon or equivalent) NOTE: Manual cleaning is NOT a disinfection process. Manual Pre-Cleaning Instructions

1

Prepare a detergent solution using neodisher MediClean forte prepared using 5 mL detergent per liter of water (0.5%).

2

Disassemble the tray into the following components as applicable: Lid, Top Tray Insert, Second Tray Insert and Tray Base.

3

Immerse the tray components in the detergent solution and soak for a minimum of five (5) minutes.

4

While immersed, brush each component for a minimum of two (2) minutes (each) until visibly clean using a non-abrasive, nylon bristled brush (Sklar #10-1444 Double End Brush Nylon).

5

Immerse each tray component in a tap water bath for a minimum of one (1) minute.

4

Automated Cleaning Instructions 1

Before automated cleaning, devices must be cleaned in accordance with the Manual Pre-Cleaning Steps.

2

Place the disassembled, empty trays in a washer-disinfector to allow for draining.

3

Perform the following automated cycle: Pre-Wash

RECIRCULATION TIME (MINUTES : SECONDS) 02:00

Wash

10:00

Rinse

0:15

Thermal Rinse

05:00

Drying

15:00

PHASE

TEMPERATURE Cold Heated 140°F / 60.0°C Hot Heated 194°F / 90.0°C 210°F / 98.8°C (High)

DETERGENT / WATER TYPE Tap neodisher MediClean forte (5 mL per L water) Tap High Purity N/A

4

If needed, thoroughly dry the tray components with clean, nonlinting cloth/wipes.

5

Visually inspect each tray component for the absence or presence of remaining soil in a well-lit area.

Recommendations for Sterilization of Simplify Disc Instruments Loosen or fully open moveable features of instruments, and place in the cervical tray as illustrated on the tray. Latch the lid securely in place prior to wrapping. Wrap the trays using the AAMI CSR double wrap method prior to sterilization to maintain sterility of internal components. Wrap the tray in a medical grade sterilization pouch or wrap which conforms to the recommended specifications for steam sterilization provided below (for example: Cardinal Health Convertor Brand Bio-Shield Regular Sterilization Wrap; Ref Number: 4040, Lot Number: 19EDDNB016, 510(k) reference number: K770933). Ensure that the pouch or wrap is large enough to contain the tray without stressing the seals or tearing the pouch or wrap. The wrapped Simplify Disc Instrument Sets should be sterilized in the tray provided, in a prop- erly functioning and calibrated autoclave. NOTE: It is the responsibility of the hospital to ensure that reprocessing is performed using the appropriate equipment and materials, and that personnel in the reprocessing facility have been adequately trained in order to achieve the desired result. Equipment and processes should be validated and routinely monitored. Any deviation by the processor from these instructions should be properly evaluated for effectiveness to avoid potential adverse consequences.

5

NOTE: At some point in time, instruments wear out and should be replaced. It is the responsibility of the user to ensure each instrument is visually inspected according to the instructions provided in the following sections.

Recommended minimum sterilization parameters that have been validated to provide a 10-6 sterility assurance level (SAL) are: Method: Temperature: Exposure Time: Dry Cycle:

Pre-vacuum Steam 132°C (270°F) 4 minutes 20 minutes

Warning • Do not use these instruments for any action for which it was not intended such as prying or lifting.

AND: Method: Temperature: Exposure Time: Dry Cycle:

Pre-vacuum Steam 134°C (273°F) 3 minutes 30 minutes

• To avoid injury, the instruments should be carefully examined prior to use for functionality or damage. A damaged instrument should not be used. • The Simplify Disc Instruments should only be used by surgeons who are experienced with anterior cervical spinal procedures.

The user/processor should comply with local laws and ordinances in countries where reprocessing requirements are more stringent than those provided above.

• Correct selection, assembly and placement of the instruments for the appropriate implant core are essential to ensure proper performance and functioning of the instruments. Information regarding the selection, assembly and placement of the instruments is provided in the Simplify Disc Surgical Technique Guide.

NOTE: Do not stack trays during sterilization. Use of this cycle is validated to produce a Sterility Assurance Level (SAL) of at least 10-6. Caution Handle devices with care to prevent cutting surgical gloves with sharp-edged surgical instruments.

• Due to the proximity of vascular structures, neurological structures, and major organ systems to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurological damage and/or injury to adjacent organs with the use of Simplify Disc Instruments. Care must be taken to identify and protect these structures.

Limits on Reprocessing Simplify Disc Instruments lifespan is normally determined by wear and damage due to use. Instruments should not be expected to last indefinitely. These items are often subjected to high loads and/or impact forces. Before each use carefully inspect all instruments. Do not use an instrument that is severely corroded, marred or worn or cutting instruments with dull edges. Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used. It is the responsibility of the user to ensure each instrument is visually inspected according to the instructions provided.

• The Simplify Disc Instruments is not to be used with any other device. • Do not use the tray for any action for which it was not intended. NuVasive, Inc. does not and cannot warrant the use of Simplify Disc Instruments nor any of the component parts upon which repairs have been made or attempted except as performed by NuVasive, Inc.

6

Residual Risks and Possible Adverse Effects • 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 and sterilization procedures can render an instrument unsuitable for its intended purpose, or even dangerous to the patient or surgical staff. • Possibility that an instrument fragment may be left in the body. • Proper patient selection and operative care are critical to the success of the device and avoidance of injury during surgery. Read and follow all other product information supplied by the manufacturer of the implants or the instruments. • Extreme care should be taken to ensure that the instruments remain in good working order. Any surgical techniques applicable for use of this system should be carefully followed. The residual risks identified with using the Simplify Disc Instruments can be grouped into the following categories: disassembly, moving parts, torsion, shear and tensile forces, instrument misuse, improper device sizing, device fragmentation, sharp edges, patient with greater risk factors, local tissue discoloration, significant impairment, significant but temporary or reversible illness, impairment or injury, illness, impairment, or injury that necessitates medical or surgical intervention beyond the standard of care to correct or prevent serious injury, nerve root impingement, vertebral body fracture, damage to vertebral endplate, spinal cord injury, injury to vertebral artery, dysphagia/dysphonia.

7

Contraindications

Other Precautions

The instrument tray is intended only for use with Simplify Disc Instrument sets. Do not add instruments to the set. Sterilization of contents other than Simplify Disc Instrument Set has not been validated.

1. Excessive forces when using instruments can be dangerous. 2. Any form of distortion or excessive wear on instruments may cause a malfunction that could lead to serious patient injury.

Storage and Transportation Simplify Disc Instrument Set trays may be used as a packaging system for transportation of instruments.

3. Regularly review the operational state of all instruments and, if necessary, make use of repair and replacement services. Limited warranty and disclaimer:

NuVasive, Inc. products are provided with a limited written warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness for a particular purpose, are hereby disclaimed.

Table 2: Description of Symbols used in packaging

8

NuVasive, Inc. 7475 Lusk Blvd. San Diego, CA 92121 USA USA Phone: +01.800.475.9131 USA Fax: +01.800.475.9134 www.nuvasive.com Australian Sponsor: NuVasive Australia & NZ PTY LTD. Building 9 588A Swan Street Richmond VIC 3121 Melbourne, Australia

NuVasive Netherlands B.V Jachthavenweg 109A 1081 KM Amsterdam The Netherlands Phone: +31 20 72 33 000

NuVasive Switzerland GmbH c/o Domenghini & Partners AG Falkengasse 3 6004 Luzern, Switzerland UK Responsible Person: NuVasive UK Limited Suite B, Ground Floor, Caspian House, The Waterfront, Elstree, Herts, WD6 3BS, United Kingdom

Please see www.nuvasive.com/eifu for complete instructions for use for Simplify Disc and Simplify Disc Instruments. 32175-EN_N-2022-08