Simplify Disc Accessory Kit Instructions for Use

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

Warning

Handle instruments with care to prevent cutting surgical gloves with sharp-edged surgical instruments.

• Do not use these instruments for any action for which they were not intended such as prying or lifting. • To avoid injury, the instruments should be carefully examined prior to use for functionality or damage. A damaged instrument should not be used.

Limits on Reprocessing Simplify Disc Accessory Kit 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 corroded, marred or worn or cutting instruments with dull edges. Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed out) part numbers, damaged and excessively worn devices should not be used.

• The Simplify Disc Accessory Kit should only be used by surgeons who are experienced with anterior cervical spinal procedures. • 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: 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.

• 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 Accessory Kit. Care must be taken to identify and protect these structures. • The Simplify Disc Accessory Kit is intended to be used only with Simplify Disc and is not to be used with any other device.

NuVasive,Inc.doesnotandcannotwarranttheuseofSimplifyDiscAccessoryKitnoranyofthecomponent partsuponwhichrepairshavebeenmadeorattemptedexceptasperformedbyNuVasive,Inc.

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Possible Adverse Effects

Other Precautions

• Breakage, slippage, misuse, or mishandling of instruments, such as on sharp edges, may cause injury to the patient or operative personnel.

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.

• Improper maintenance, handling, or poor cleaning and sterilization procedures can render the instrument unsuitable for its intended purpose, or even dangerous to the patient or surgical staff.

3. Regularly review the operational state of all instruments and, if necessary, make use of repair and replacement services. Contraindications

• Possibility that an instrument or device fragment may be left in the body.

The Simplify Disc Accessory Kit is intended to be used only with Simplify Disc and is not to be used with any other device. Do not add instruments to the set. Sterilization of contents other than Simplify Disc Accessory Kit has not been validated.

• 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.

Storage and Transportation The Accessory Kit Instrument Set tray may be used as a packaging system for transportation of instruments.

CR Handle CR Housing CR Jaw Small CR Jaw Large CR Core Gauge Osteotome (5mm)

Figure 1: Simplify Disc Accessory Kit showing instruments and sterilization case.

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Recommendations for Care and Cleaning of Simplify Disc Accessory Kit 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

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.

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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 neodisher MediClean 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.

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

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

2

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:

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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.

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Recommendations for Care and Cleaning of Simplify Disc Instrument 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 four (4) components: 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 of four (4) components for a minimum of two (2) minutes (each) and 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.

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. 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

3

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.

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Recommendations for Sterilization of Simplify Disc Accessory Kit Disassemble instruments, and place in the Accessory Kit tray as illustrated on the tray lid. 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.

Figure 2: Simplify Disc Accessory Kit

The wrapped Simplify Disc Accessory Kit should be sterilized in the tray provided, in a properly 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.

Recommended minimum sterilization parameters that have been validated to provide a 10-6 sterility assurance level (SAL) are:

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

Method: Temperature: Exposure Time: Dry Cycle:

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.

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

Limitedwarrantyanddisclaimer: 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.

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

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

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Please see www.nuvasive.com/eifu for complete instructions for use for Simplify Disc and Simplify Disc Instrument Set. 32156-EN_K-2022-06