Computer Aided Surgery Systems Equipment Cleaning and Sterilization Instructions

Cleaning, Inspection, and Sterilization Instructions Instructions for devices that must be cleaned using automated washer/disinfectors without sonication, or cleaned manually with sonication Instruction set 1: Instructions for devices that must be cleaned using automated washer/disinfectors without sonication, or cleaned manually with sonication Limitations on Reprocessing

End of useful life is normally determined by wear and damage due to use. See “Maintenance Inspection Testing” on page 3 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.

Containment and Transportation

Reprocessing begins at the point of use. 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 potable water with a hardness value between 0.7 mmol/l – 2.0 mmol/l. Caution: Devices should be cleaned within 30 minutes of use to limit fixation of contaminants.To prolong the life of the device, reprocess immediately after use. Warning: To prevent cross-contamination, always handle, transport, clean, disinfect, sterilize, and package devices contacting the central nervous system separately from other devices.

Preparation for Cleaning

Remove any single-use spheres 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. If you are unsure how to disassemble the device in preparation for cleaning, refer to the device-specific instructions for use, or contact Medtronic Navigation™technical support at 800 595 9709 or 720 890 3160. Before the cleaning step, thoroughly rinse the device under running cold tap water at a temperature of 10 – 16°C (50 – 61°F) to remove any visible soil. Use a soft-bristled brush or clean cloth to aid soil removal. Give particular attention to crevices, lumens and other areas that present a challenge to cleaning. For cannulated devices that are used with guide-wires, 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.

Automated Cleaning

Caution: Follow EN ISO 15883-1 for load and thermometric settings for all washer-disinfectors. Transfer the devices to the washer and select the instrument cycle. Ensure the following set of cycle parameters are properly programmed. Caution: Use the device sterilization tray for sterilization only, not for cleaning or disinfection. Phase

Recirculation/Soak

Water Temperature

Detergent Type

Prewash 1

2 minutes (02:00)

Cold tap water 10 – 16°C (50 – 61°F)

N/A

Enzyme Wash

2 minutes (02:00)

Hot tap water 43 – 55°C (109 – 131°F)

Steris Prolystica™2x Concentrate Enzymatic Cleaner, 1.0 ml/L (⅛ oz/gal), or equivalent neutral pH enzymatic detergent.

Wash 1

2 minutes (02:00)

66°C (151°F) (setpoint)

Steris Prolystica™2x Concentrate Neutral Detergent, 1.0ml/L (⅛ oz/gal), or equivalent neutral pH detergent

Rinse 1

15 seconds (00:15)

Hot tap water 43 – 60°C (109 – 140°F)

N/A

Thermal Rinse

1 minute (01:00)

90°C (194°F) (setpoint)

N/A

Purified Water Rinse

10 seconds (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.

Page 2

Equipment Cleaning and Sterilization, continued Instruction set 1: Instructions for devices that must be cleaned using automated washer/disinfectors without sonication, or cleaned manually with sonication (Continued) Manual Cleaning

Manually clean the device only when a washer-disinfector is not available. 1.

Prepare a neutral enzymatic detergent such as Steris Prolystica™2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of ⅛ oz/gal at a temperature of 23°C (73°F), or use an equivalent neutral pH detergent following that manufacturer’s recommendations. Immerse the device in the prepared enzymatic detergent, actuate the device and allow it to soak for a minimum of 10 minutes.

2.

Thoroughly clean the device. Pay particular attention to crevices, lumens and other hard-to-clean areas to remove all visible soil. For cannulated devices that are used with guide-wires, use an appropriately-sized brush, cleaning stylet, or pipe cleaner to clean a 1.50 mm diameter cannula.

3.

Prepare a fresh neutral enzymatic detergent such as Steris Prolystica™2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of ⅛ oz/gal at a temperature of 23°C (73°F), or use an equivalent neutral pH detergent following that manufacturer’s recommendations. Using a syringe repeatedly flush lumens, blind holes, and cracks until the solution runs clear. Allow detergent solution into hard-to-reach areas.

4.

After soaking, the device should be thoroughly rinsed under running warm tap water at a temperature of 30 – 45°C (86 – 113°F) for a minimum of 1 minute to remove all residual detergent. Actuate the device during rinse to allow water into hard-to-reach areas. Use a syringe to aid in rinsing.

5.

In a sonication unit, prepare a neutral enzymatic detergent such as Steris Prolystica™2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of ⅛ oz/gal at a temperature of 23°C (73°F), or use an equivalent neutral pH detergent following that manufacturer’s recommendations. Completely submerge the device in the prepared enzymatic detergent and allow it to sonicate for a minimum of 10 minutes.

6.

After sonication, the device should be thoroughly rinsed under running warm tap water at a temperature of 30 – 45°C (86 – 113°F) for a minimum of 1 minute to remove all residual detergent. Actuate the device during rinse to allow water into hard-to-reach areas. Use a syringe to aid in rinsing.

7.

Following the warm tap water rinse, the device should be thoroughly rinsed in room temperature (25°C) (77°F) purified water (deionized, reverse osmosis, or equivalent) for a minimum of 30 seconds. Use a syringe to aid in rinsing.

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

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. Additionally, check for the following: • Laser etchings, engravings, and other markings that are illegible. • Cracks in the handle or any other part of the device. • Discoloration, corrosion, stains or rust. If present, attempt to clean the device using the cleaning instructions provided in this document. If reprocessing does not remove the discoloration, corrosion, stains, or rust, the device is at the end of its useful life. • Damage to the working end or tip. The working end should be free from cracks, sharp-edged gouges, and other damage. • Missing parts or parts that are damaged and deteriorated. • Mating ends that have damage (such as nicks, gouges, bends, and so forth) that interfere with the mating function. • An insecure handle-to-shaft connection, on devices that have such a connection. • Damaged threads, on a device that has threads. A device that 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. Contact Medtronic Navigation.

Part Number 9730713, revision 17

Page 3

Instruction set 1: Instructions for devices that must be cleaned using automated washer/disinfectors without sonication, or cleaned manually with sonication (Continued) Packaging

The user facility is responsible for using only accessories (such as sterilization wraps, chemical indicators, and biological indicators) that have been approved by the Food and Drug Administration for medical facilities inside the U.S.A. and its territories, or conform to EN ISO 11607 for medical facilities outside the U.S.A. and its territories. 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 or tray is not available. Caution: The device sterilization tray is to be used for sterilization only, not for cleaning or disinfection. Caution: Do not wrap rigid sterilization containers.

Sterilization

Warning: 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. Caution: Devices cannot be sterilized to an adequate Sterility Assurance Level without prior cleaning. Caution: Do not sterilize the device at temperatures greater than 137°C (279°F). These sterilization instructions have been validated to a sterility assurance level of 10 -6. 1.

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

2.

Program the sterilizer with the parameters found in Table A for medical facilities inside the U.S.A. and its territories, or one of the parameter sets in Table B for medical facilities outside the U.S.A. and its territories.

Table A: Sterilization cycle parameters for the medical facilities inside the United States of America and its territories Method

Cycle

Temperature

Exposure time

Minimum Dry Time1

Steam

Prevacuum

132°C (270°F)

4 minutes

30 minutes

Table B: Sterilization cycle parameters for medical facilities outside the United States of America and its territories Method

Cycle

Temperature

Exposure time

Minimum Dry Time1

Steam

Prevacuum

132°C (270°F)

4 minutes

30 minutes

Steam

Prevacuum

134°C (273°F)

18 minutes

30 minutes

1 Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient

atmospheric pressure may require more time. Storage

Page 4

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

Equipment Cleaning and Sterilization, continued Instructions for wired (active) devices that must be cleaned using manual methods Warning: Disconnect active instruments from system or power sources before reprocessing Caution: Do not submerge components that contain LEDs or any other electronics and do not allow liquid to enter the electrical connections. Electronic components may be permanently damaged as a result of submersion. Allow any submerged component 24 hours of air-dry time before attempting to assess damage. Instruction set 2: Instructions for wired (active) devices that must be cleaned using manual methods Limitations on Reprocessing

End of useful life is normally determined by wear and damage due to use. See “Maintenance Inspection Testing” on page 6 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.

Containment and Transportation

Reprocessing begins at the point of use. If the device cannot be reprocessed immediately, keep the device moist during transport. For example, fully submerge a cloth in tap water or in a prepared pH-neutral enzymatic solution per detergent manufacturer’s recommendation. Wrap the device in this cloth. Tap water is defined as potable water with a hardness value between 0.7 mmol/l – 2.0 mmol/l. Caution: Devices should be cleaned within 30 minutes of use to limit fixation of contaminants. To prolong the life of the device, reprocess immediately after use. Warning: To prevent cross-contamination, always handle, transport, clean, disinfect, sterilize, and package devices contacting the central nervous system separately from other devices.

Preparation for Cleaning

1.

Disengage all components.

2.

Use a soft-bristled brush or clean cloth to remove visible soil. Give particular attention to crevices, lumens and other areas that present a challenge to cleaning. Carefully inspect devices, including any lumens and cavities, to ensure all visible soil is removed.

Automated Cleaning

Warning: Do not use an automated washer-disinfector.

Manual Cleaning

Caution: Use the device sterilization tray for sterilization only, not for cleaning or disinfection. 1.

Prepare a neutral enzymatic detergent such as Steris Prolystica™2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of ⅛ oz/gal at a temperature of 23°C (73°F), or use an equivalent neutral pH detergent following that manufacturer’s recommendations.

2.

Soak a clean cloth in the detergent solution and wipe each portion of the device (cable and body) for a minimum of 3 minutes.

3.

Thoroughly clean the device using a soft-bristled brush. Pay particular attention to crevices and other hard-toclean areas to remove all foreign matter.

4.

Flush crevices and blind holes in the device with fresh detergent solution.

5.

Flush the device with purified water (deionized, reverse osmosis, or equivalent).

6.

Soak a clean cloth in purified water (deionized, reverse osmosis, or equivalent) and wipe each portion of the device (cable and body) for a minimum of 2 minutes to remove any residual detergent.

7.

Dry the device with a clean, soft cloth.

8.

Inspect for spotting, residues, debris, or visible particulate matter on reprocessed devices.

Caution: Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat cleaning. Drying

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

Part Number 9730713, revision 17

Page 5

Instruction set 2: Instructions for wired (active) devices that must be cleaned using manual methods (Continued) 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. Additionally, check for the following: • Laser etchings, engravings, and other markings that are illegible. • Cracks in the handle or any other part of the device. • Discoloration, corrosion, stains or rust. If present, attempt to clean the device using the cleaning instructions provided in this document. If reprocessing does not remove the discoloration, corrosion, stains, or rust, the device is at the end of its useful life. • Damage to the working end or tip. The working end should be free from cracks, sharp-edged gouges, and other damage. • Missing parts or parts that are damaged and deteriorated. • Mating ends that have damage (such as nicks, gouges, bends, and so forth) that interfere with the mating function. • An insecure handle-to-shaft connection, on devices that have such a connection. • Damaged threads, on a device that has threads. A device that 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. Contact Medtronic Navigation.

Packaging

The user facility is responsible for using only accessories (such as sterilization wraps, chemical indicators, and biological indicators) that have been approved by the Food and Drug Administration for medical facilities inside the U.S.A. and its territories, or conform to EN ISO 11607 for medical facilities outside the U.S.A. and its territories. 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 or tray is not available. Caution: The device sterilization tray is to be used for sterilization only, not for cleaning or disinfection. Caution: Do not wrap rigid sterilization containers.

Sterilization

Warning: 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. Caution: Devices cannot be sterilized to an adequate Sterility Assurance Level without prior cleaning. Caution: Do not sterilize the device at temperatures greater than 137°C (279°F). These sterilization instructions have been validated to a sterility assurance level of 10 -6. 1.

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

2.

Program the sterilizer with the parameters found in Table C for medical facilities inside the U.S.A. and its territories, or one of the parameter sets in Table D for medical facilities outside the U.S.A. and its territories.

Table C: Sterilization cycle parameters for the medical facilities inside United States of America and its territories Method

Cycle

Temperature

Exposure time

Minimum Dry Time1

Steam

Prevacuum

132°C (270°F)

4 minutes

30 minutes

Table D: Sterilization cycle parameters for medical facilities outside the United States of America and its territories

1

Storage

Page 6

Method

Cycle

Temperature

Exposure time

Minimum Dry Time1

Steam

Prevacuum

132°C (270°F)

4 minutes

30 minutes

Steam

Prevacuum

134°C (273°F)

18 minutes

30 minutes

Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient atmospheric pressure may require more time.

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

Equipment Cleaning and Sterilization, continued Instructions for devices that must be cleaned using automated washer/disinfectors with sonication, or cleaned manually with sonication Instruction set 3: Instructions for devices that must be cleaned using automated washer/disinfectors with sonication, or cleaned manually with sonication Limitations on Reprocessing

End of useful life is normally determined by wear and damage due to use. See “Maintenance Inspection Testing” on page 9 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.

Containment and Transportation

Reprocessing begins at the point of use. 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 potable water with a hardness value between 0.7 mmol/l – 2.0 mmol/l. Caution: Devices should be cleaned within 30 minutes of use to limit fixation of contaminants. To prolong the life of the device, reprocess immediately after use. Warning: To prevent cross-contamination, always handle, transport, clean, disinfect, sterilize, and package devices contacting the central nervous system separately from other devices.

Preparation for Cleaning

Remove any single-use spheres 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. If you are unsure how to disassemble the device in preparation for cleaning, refer to the device-specific instructions for use, or contact Medtronic Navigation™technical support at 800 595 9709 or 720 890 3160. Before the cleaning step, thoroughly rinse the device under running cold tap water at a temperature of 10 – 16°C (50 – 61°F) to remove any visible soil. Use a soft-bristled brush or clean cloth to aid soil removal. Give particular attention to crevices, lumens and other areas that present a challenge to cleaning. For cannulated devices that are used with guide-wires, 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.

Part Number 9730713, revision 17

Page 7

Instruction set 3: Instructions for devices that must be cleaned using automated washer/disinfectors with sonication, or cleaned manually with sonication (Continued) Automated Cleaning

Caution: Follow EN ISO 15883-1 for load and thermometric settings for all washer-disinfectors. Caution: Use the device sterilization tray for sterilization only, not for cleaning or disinfection. 1.

Prepare a neutral enzymatic detergent such as Steris Prolystica™2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of ⅛ oz/gal at a temperature of 23°C (73°F), or use an equivalent neutral pH detergent following that manufacturer’s recommendations. Using a syringe repeatedly flush lumens, blind holes, and cracks until the solution runs clear. Allow detergent solution into hard-to-reach areas.

2.

In a sonication unit, prepare a neutral enzymatic detergent such as Steris Prolystica™2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of ⅛ oz/gal at a temperature of 23°C (73°F), or an equivalent neutral pH detergent following that manufacturer’s recommendations. Completely submerge the device in the prepared enzymatic detergent and allow it to sonicate for a minimum of 10 minutes.

3.

After sonication, the device should be thoroughly rinsed under running warm tap water at a temperature of 30 – 45°C (86 – 113°F) for a minimum of 1 minute to remove all residual detergent. Actuate the device during rinse to allow water into hard-to-reach areas. Use a syringe to aid in rinsing.

4.

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

Phase

Recirculation/Soak

Water Temperature

Detergent Type

Prewash 1

2 minutes (02:00)

Cold tap water 10 – 16°C (50 – 61°F)

N/A

Enzyme Wash

2 minutes (02:00)

Hot tap water 43 – 55°C (109 – 131°F)

Steris Prolystica™2x Concentrate Enzymatic Cleaner, 1.0 ml/L (⅛ oz/gal), or equivalent neutral pH enzymatic detergent.

Wash 1

2 minutes (02:00)

66°C (151°F) (setpoint)

Steris Prolystica™2x Concentrate Neutral Detergent, 1.0ml/L (⅛ oz/gal), or equivalent neutral pH detergent

Rinse 1

15 seconds (00:15)

Hot tap water 43 – 60°C (109 – 140°F)

N/A

Thermal Rinse

1 minute (01:00)

90°C (194°F) (setpoint)

N/A

Purified Water Rinse

10 seconds (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.

Page 8

Equipment Cleaning and Sterilization, continued Instruction set 3: Instructions for devices that must be cleaned using automated washer/disinfectors with sonication, or cleaned manually with sonication (Continued) Manual Cleaning

Manually clean the device only when a washer-disinfector is not available. 1.

Prepare a neutral enzymatic detergent such as Steris Prolystica™2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of ⅛ oz/gal at a temperature of 23°C (73°F), or use an equivalent neutral pH detergent following that manufacturer’s recommendations. Immerse the device in the prepared enzymatic detergent, actuate the device and allow it to soak for a minimum of 10 minutes.

2.

Thoroughly clean the device. Pay particular attention to crevices, lumens and other hard-to-clean areas to remove all visible soil. For cannulated devices that are used with guide-wires, use an appropriately-sized brush, cleaning stylet, or pipe cleaner to clean a 1.50 mm diameter cannula.

3.

Prepare fresh neutral enzymatic detergent such a Steris Prolystica™2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of ⅛ oz/gal at a temperature of 23°C (73°F), or use an equivalent neutral pH detergent following that manufacturer’s recommendations. Using a syringe repeatedly flush lumens, blind holes, and cracks until the solution runs clear. Allow detergent solution into hard-to-reach areas.

4.

After soaking, the device should be thoroughly rinsed under running warm tap water at a temperature of 30 – 45°C (86 – 113°F) for a minimum of 1 minute to remove all residual detergent. Actuate the device during rinse to allow water into hard-to-reach areas. Use a syringe to aid in rinsing.

5.

Prepare a neutral enzymatic detergent such as Steris Prolystica™2x Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of ⅛ oz/gal at a temperature of 23°C (73°F) in a sonication unit, or use an equivalent neutral pH detergent following that manufacturer’s recommendations. Completely submerge the device in the prepared enzymatic detergent and allow it to sonicate for a minimum of 10 minutes.

6.

After sonication, the device should be thoroughly rinsed under running warm tap water at a temperature of 30 – 45°C (86 – 113°F) for a minimum of 1 minute to remove all residual detergent. Actuate the device during rinse to allow water into hard-to-reach areas. Use a syringe to aid in rinsing.

7.

Following the warm tap water rinse, the device should be thoroughly rinsed in room temperature (25°C) (77°F) purified water (deionized, reverse osmosis, or equivalent) for a minimum of 30 seconds. Use a syringe to aid in rinsing.

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

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. Additionally, check for the following: • Laser etchings, engravings, and other markings that are illegible. • Cracks in the handle or any other part of the device. • Discoloration, corrosion, stains or rust. If present, attempt to clean the device using the cleaning instructions provided in this document. If reprocessing does not remove the discoloration, corrosion, stains, or rust, the device is at the end of its useful life. • Damage to the working end or tip. The working end should be free from cracks, sharp-edged gouges, and other damage. • Missing parts or parts that are damaged and deteriorated. • Mating ends that have damage (such as nicks, gouges, bends, and so forth) that interfere with the mating function. • An insecure handle-to-shaft connection, on devices that have such a connection. • Damaged threads, on a device that has threads. A device that 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. Contact Medtronic Navigation.

Packaging

The user facility is responsible for using only accessories (such as sterilization wraps, chemical indicators, and biological indicators) that have been approved by the Food and Drug Administration for medical facilities inside the U.S.A. and its territories, or conform to EN ISO 11607 for medical facilities outside the U.S.A. and its territories. 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 or tray is not available. Caution: The device sterilization tray is to be used for sterilization only, not for cleaning or disinfection. Caution: Do not wrap rigid sterilization containers.

Part Number 9730713, revision 17

Page 9

Instruction set 3: Instructions for devices that must be cleaned using automated washer/disinfectors with sonication, or cleaned manually with sonication (Continued) Sterilization

Warning: 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. Caution: Devices cannot be sterilized to an adequate Sterility Assurance Level without prior cleaning. Caution: Do not sterilize the device at temperatures greater than 137°C (279°F). These sterilization instructions have been validated to a sterility assurance level of 10 -6. 1.

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

2.

Program the sterilizer with the parameters found in Table E for medical facilities inside the U.S.A. and its territories, or one of the parameter sets in Table F for medical facilities outside the U.S.A. and its territories.

Table E: Sterilization cycle parameters for the medical facilities inside United States of America and its territories Method

Cycle

Temperature

Exposure time

Minimum Dry Time1

Steam

Prevacuum

132°C (270°F)

4 minutes

30 minutes

Table F: Sterilization cycle parameters for medical facilities outside the United States of America and its territories

1

Storage

Page 10

Method

Cycle

Temperature

Exposure time

Minimum Dry Time1

Steam

Prevacuum

132°C (270°F)

4 minutes

30 minutes

Steam

Prevacuum

134°C (273°F)

18 minutes

30 minutes

Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient atmospheric pressure may require more time.

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

Equipment Cleaning and Sterilization, continued Index of Devices Part Number

Description

Egg Quick Connect Handle

963-778

4.5 mm Diameter Cannula

960-341

Awl Tip

963-791

Long Percutaneous Clamp

960-342

Probe Tip

963-792

Short Percutaneus Clamp

960-521

UC Drill Guide

963-793

Percutaneous Starburst

960-522

UC Drill Guide Trocar

963-794

45° Perc Post

960-523

3 mm UCD Bit Guide

963-795

Percutaneous Screwdriver

960-524

3 mm UC Drill Guide Bit

963-850

Fighter Insertion/Removal Tool

960-527

3 mm Cancellous Bit

963-864

Passive Orthopedic Frame

960-535

Mayfield™Mount Double Star Adapter

9680149

Touchsite Stylus

960-537

Articulating Arm

9730027

Open Spine Clamp Driver

960-539

Biopsy Guide

9730092

PCI Handle

960-615

Linear Sharp Probe

9730269

Microscope Probe

960-717

3.2 mm Adjustable Drill Stop

9730288

Precimed Reamer Adapter

961-337

Small Passive Cranial Reference Frame

9730289

Orthopedic, Dovetail Clamp

961-349

Sugita™Headframe Adapter

9730422

Precimed Teflon Reamer Sleeve

961-576

SureTrak™II Small Clamp

9730476

3 in Fixator Pin

961-578

SureTrak™ II Medium Clamp

9730477

5 in Fixator Pin

961-579

SureTrak™ II Med Passive Fighter

9730478

Precimed Reamer Verification Tip

961-580

SureTrak™ II Large Clamp

9730489

TeraTracker, Blue Tracker

961-581

SureTrak™ II Large Passive Fighter

9730490

TeraTracker, Green Tracker

961-584

SureTrak™ II Clamp Driver

9730491

TeraTracker, Gold Tracker

962-123

90° Jamshidi™Mount

9730492

TeraTracker, Purple Tracker

963-774

Modular Drill Guide-Short

9730605

Small Passive Reference Frame

963-775

2.5 mm Diameter Cannula

9730818

Right Tactile Probe

963-776

2.9 mm Diameter Cannula

9730819

Left Tactile Probe

963-777

3.2 mm Diameter Cannula

9730820

Tactile Awl

Part Number

Description

960-339

Part Number 9730713, revision 17

Use Instruction Set

Use Instruction Set

Page 11

Part Number

Description

9730864

Part Number

Description

2-Pin Fixator

9732772

150 mm Cannula

9730873

4.0 mm Hex Wrench

9733037

AxiEM™ Spine Reference Clamp

9730944

4.5 mm Cannulated Tap

9733139

Cannulated Vertex™ Max Trocar

9730945

5.5 mm Cannulated Tap

9733140

9730946

6.5 mm Cannulated Tap

Cannulated Vertex™ Max Drill Tube

9733148

Radiolucent Thoracic Clamp

9731110

Image Guided Handle

9733157

Navigus™ Probe

9731450

Mobile Localizer Holder

9733158

Vertek™ Probe

9731567

Small Passive Orange Fighter

9733161

Cannulated Vertex™ Max Awl

9731780

Ti Open Spine Clamp

9733182

9731833

1/4 in Ball Hex Driver

Vertex™ Max Cannulated 1.86p, 4.0 mm Tap

9733183

Vertex™ Max Cannulated 4.5 mm Tap

9733184

Vertex™ Max Cannulated 4.0 mm, 1.5p Tap

9733213

1.9 mm Reducing Tube

9733214

2.2 mm Reducing Tube

9733215

2.6 mm Reducing Tube

9733223

Cannulated Universal Handle

9733332

Adjustable Stop

9733457

Pedicle 2.25 mm Probe

9733504

0° Light Reference Frame

9733505

90° Light Reference Assembly

9733509

3.5 mm Vertex™ Max Tap

9733510

4.0 mm 10-24 mm Vertex™ Max Tap

9733511

4.0 mm 26-52 mm Vertex™ Max Tap

9733512

4.5 mm Vertex™ Max Tap

9733513

4.0 mm Cortical Vertex™ Max Tap

9733514

4.5 mm Cortical Vertex™ Max Tap

9733530

1.5 mm Tip Awl

9733531

2.0 mm Tip Probe

9731965

4.3 mm Ball Tip Probe

9732159

Quick Release 1 Frame

9732160

Quick Release 2 Frame

9732269

Knee Verification Plate

9732296

Long 2.5 Ball Pointer Probe

9732353

Cross Pin Perc Reference Frame

9732355

Vertex™Max Cannulated Drill Guide

9732356

Gray Passive Othopaedic Reference Frame

9732515

Left Thoracic Tactile Probe

9732516

Right Thoracic Tactile Probe

9732520

Quick Release Base

9732562

Cross Pin Tap Cap

9732563

100 mm Cannula

9732564

Cross Pin Slap Hammer

9732565

100 mm Dilator

9732566

Short Bed Rail Adapter

9732771

150 mm Dilator

Page 12

Use Instruction Set

Use Instruction Set

Equipment Cleaning and Sterilization, continued Part Number

Description

9733649

Part Number

Description

Coutertorque Assy Spine Driver

9734590

Universal Navlock™ Tracker Gray

9733701

1.6 mm Reusable Screwdriver

9734682

Universal Navlock™ Tracker Violet

9733734

Ratcheting QC Small Straight Handle

9734683

Universal Navlock™ Tracker Orange

9733816

Dilator Tracker

9734734

9733817

Navigated Dilator

Universal Navlock™ Tracker Green

9733879

Linear Blunt HC Probe

9733880

Linear Sharp HC Probe

9733881

Cranial Active HC Frame

9733884

SureTrak™ II Active HC Fighter

9733885

Active HC Fighter

9733886

Small Active HC Frame

9733887

Ortho HC Frame

9734036

Drill Guide Aggressive Tip Bit

9734051

Instrument Small SureTrak™ II Clamp

9734054

Large Polestar™ SureTrak™ II Tracker

9734228

NavLock™ Driver Assembly Gray

9734259

NavLock™ Driver Assembly Orange

9734315

NavLock™ Driver Assembly Violet

9734410

Ratcheting Egg Handle

9734433

Right Lumbar Tactile Probe

9734434

Left Lumbar Tactile Probe

9734435

Tactile Awl

9734436

Left Thoracic Tactile Probe

9734437

Right Thoracic Tactile Probe

9734439

Percutaneous Ball Driver

9734450

Insertion / Removal Tool

Part Number 9730713, revision 17

Use Instruction Set

Use Instruction Set

Page 13

ȤŋȦƮƗŢőƝūƞŋȯʼnĖĉĚõûǮȥ Page 14