Medtronic ML-0714 Instructions for Use

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Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 1 of 12

Manufacturer: Titan Spine a division of
Medtronic

Method: Manual and Automated Cleaning with Steam Sterilization
Devices: All Titan devices provided non-sterile.

This document contains instructions for cleaning, disinfection, and sterilization of Titan product provided non-sterile,
including implants, instruments, caddies and trays. Reusable instruments may enter normally sterile parts of the human
body and are considered critical items. The cleaning and sterilization methods described below have been validated for
use at an accredited laboratory per standards ANSI/AAMI TIR12, ANSI/AAMI TIR30, and ISO 17665-1. Cleaning and
sterilization validations are summarized in the Additional Information section of this document. Any deviation from the
suggested reprocessing methods should be evaluated for effectiveness using an approved method or standard and
must be validated by the end user. Hospital approved methods should be followed when handling implants or
instruments contaminated with blood, tissue, and/or bodily fluid. Proper personal protection equipment (PPE) per
hospital procedures must be donned when handling product. Only trained personnel shall conduct reprocessing tasks.
Any Titan product that appears to be damaged or corroded should not be used and a Medtronic representative should
be notified immediately in order that product may be returned; damaged product should be reprocessed prior to
shipment. Aesculap® SterilContainersTM should be reprocessed according to the manufacturer’s specifications.

WARNINGS

• The World Health Organization (WHO) recommends special CJD (Creutzfeldt - Jakob disease)
inactivation processing procedures. Consult a WHO representative for further information, if you
have reason to believe a device has been contaminated.

• Instrument surfaces can be damaged by improper handling; handle with care.

• Take care while handling sharp instruments to avoid injury.

• Abrasive cleaners or cleaning tools, such as steel wool, are to be avoided.

• Improper concentrations of cleaning agents can damage stainless steel, titanium and aluminum

device’s protective surface leading to corrosion, discoloration, unrecognizable markings and other
surface conditions. When using such products, be sure to follow manufacture recommended
concentration, exposure time, temperature and material compatibility. Detergents with a pH
between 7 and 9.5 are recommended. Certain plastics may become brittle or discolored due to
excessive reprocessing. Follow manufacture recommended instructions when using disinfection
units, cleaning agents and all other mechanical cleaning devices.

• Do not exceed 137°C (279°F) during reprocessing steps.

• Note: The cleaning and disinfecting equipment should comply with the requirements of ISO 15883.

Follow special instructions of the manufacturer for the automated washing device. Devices must
be sterilized in a properly functioning, calibrated steam sterilizer.

Limitations on
Reprocessing

Repeated reprocessing of medical devices has minimal effect on the devices. The end of life of Titan
devices will be determined through inspection processes of each implant, instrument, caddy and tray
after reprocessing. All devices are to be examined for functional integrity, corrosion and damage
(proper assembly, scratches and dents, material residue, discoloration, impurities, etc.). Damaged
devices, those with unrecognizable markings, signs of corrosion or dull edges should not be used
and must be properly cleaned and sterilized before notifying a Medtronic representative and returning
the product to Medtronic.

Reprocessing Instructions

The instructions provided have been validated by the manufacturer of the medical device as being capable of preparing
a medical device for reuse. It remains the responsibility of the processor to ensure that the processing, as actually
performed using equipment, materials and personnel in the processing facility, achieves the desired result. This
requires verification and/or validation and routine monitoring of the process.

Initial
treatment at
the point of
use

Instruments should be wiped clean of gross soil and kept moist to prevent drying before transferring
instruments to the central processing department. Do not place used instruments back into the tray
before cleaning. Transport used instruments in a closed puncture-proof container to the reprocessing
area to avoid potential environmental contamination. Fragile instruments may be transported in a
separate container to avoid damaging the instruments. Clean instruments as soon as possible after
use. Adequate cleaning must be carried out prior to sterilization.

CONTROLLED

Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 2 of 12

Preparation
before
cleaning

The general instructions for cleaning and decontamination described in this document shall be used
for all Titan devices provided non-sterile, except those listed below. The cleaning instructions for
products listed below will be described in sections that follow, as identified by their product
information. Note: Aesculap® SterilContainersTM should be reprocessed according to the
manufacturer’s specifications.

• Endoskeleton™ TCS Torque Limiting Handle, P/N 5210-1046

• Endoskeleton™ TCS 3/16 Square, Torque Driver, P/N 5210-1076

Every implant or instrument, regardless if it has been soiled, should be processed using the following
recommendations. Remove devices form trays and caddies for cleaning. Open instrument teeth,
locks, thread locks and hinges. Multi-component instruments should be disassembled in the
reprocessing area prior to cleaning. If disassembly is required, instructions are as indicated in product
specific instructions or as described in the Additional Information section.

Sort out sharp instruments to avoid injury and use caution during manual cleaning of sharp or pointed
instruments. Carefully clean long, narrow, blind holes and inner lumen of instruments. For heavily
soiled instruments, soak, flush, rinse with cool water and wipe with cloth to prevent soil from drying, as
needed.

Cleaning:
Manual

A neutral cleaner with pH 7 – 9.5 is recommended; cleaner with a pH greater than 11 should be used
only on compatible materials according to its respective data sheet. Follow manufacturer instructions
to achieve the correct dilution, temperature, and contact time and water quality of the detergent.
Implants, instruments and cases should be cleaned in a fresh, newly prepared solution. Avoid
overloading the ultrasonic wash basket.

Manually clean and process devices using the following parameters.

Phase

Cleaning instruction

Minimum

Duration of Time

(if applicable)

Water Type and

Temperature

(if applicable)

Pre-wash

Immerse disassembled device in cold water for 5
minutes. Do not use a fixating agent or hot water as this
can cause fixation of residue.

5 minutes

Cold water

Brush device with a soft bristled nylon brush. Continue
until all visible residues are removed. Carefully clean
long, narrow, blind holes and brush inner lumen of
instruments with a suitable bottle brush. Actuate all
movable and hinged parts and clean area with a brush.

N/A

Cold water

Ultrasonic

Place device in an ultrasonic bath with a clean, freshly
prepared solution of warm (40°C), demineralized water
(DI/PURW) and cleaning product(s)* for 5 minutes.

5 minutes

Warm DI/PURW

water (40°C)

Rinse

Rinse the device thoroughly, covering all geometry with
demineralized (DI/PURW) water for 15 seconds, using a
water jet pistol for small gaps and slits as necessary.

15 seconds

DI/PURW water

Drying

Dry device with a clean, soft, lint-free cloth and/or purified
air.

N/A

N/A

*Follow the detergent manufacturer’s recommendations for the correct dilution, temperature, contact
time and water quality for the detergent. A summary of the cleaning validation is included in the
Additional Information section.

CONTROLLED

Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 3 of 12

Reprocessing Instructions for Endoskeleton™ TCS Torque Limiting Handles (P/N 5210-1046):

The recommended cleaning parameters for P/N 5210-1046 are detailed below. All torque drivers (P/N
5210-1046) are shipped in a non-sterile condition and must be cleaned and sterilized prior to use.
Torque drivers must not be disassembled for any reason. Consult the manufacturer’s specifications
for detailed instructions.

• Immediately after use, this device should be presoaked in an enzymatic detergent bath safe

for medical devices for five (5) minutes. The time and temperature of this soak should follow
the manufacturer’s instruction.

• Scrub the submerged device(s) with a soft bristle brush. Agitate the device while scrubbing.

Actuate moving parts. Use a small cytology brush to clean internal channels.

• Clean the cannulated devices using a small brush through the cannulation.

• Ultrasonically clean the instrument(s) for ten (10) minutes in a neutral pH detergent (or

acceptable alternative).

• Prepare the detergent according to the manufacturer’s recommendation.

• After presoak, the device must be rinsed in demineralized water.

Cleaning (Manual):

• Use a cleaning brush to remove any remaining soil or debris, paying special attention to small
grooves, crevices, and cannulation.

• Rinse thoroughly with warm (38-49˚ C (100-120˚F)) demineralized water. Agitate the device
for at least three (3) minutes.

• Check this device for any visible soil and repeat the cleaning process if soil is found. (A longer
presoak may be necessary.)

• Allow water to run through device. If the water leaving the device appears to be soiled, repeat
the cleaning procedure.

• Dry the exterior of the device(s) with a clean, lint-free cloth.

• DO NOT use any abrasive detergents, brushes, or cleaning pads. All brushes used should be

designed for use on medical devices.

Cleaning (Automated):

• An automatic cleaning device such as an ultrasonic cleaner is always preferred over manual
cleaning when available.

• Run the Automatic wash cycle with temperatures of 40°C and ultrasonic waves of 35 kHz for
10 minutes. These times and temperatures will vary depending on the equipment and
detergent used.

• Following cleaning, thoroughly rinse the devices with warm (38-49˚ C (100-120˚F))
demineralized water for at least one (1) minute.

• Allow water to run through device. If the water leaving the device appears to be soiled, repeat
the cleaning procedure.

• Dry the exterior of the device(s) with a clean, lint-free cloth.

• Only use an automatic cleaner that has been properly maintained and cleaned.

Steam Sterilization:
After a steam sterilization cycle the device must be allowed to cool for a minimum of 40 minutes in
(stagnant) open air or 30 minutes under forced air prior to being used. Failure to allow for proper
cooling can adversely affect torque performance.

Reprocessing Instructions for Endoskeleton™ TCS 3/16 Square, Torque Driver (P/N 5210-1076):

The recommended cleaning parameters for P/N 5210-1076 are detailed below. All torque drivers (P/N
5210-1076) are shipped in a non-sterile condition and must be cleaned and sterilized prior to use.
Torque-Limiting Drivers and Handles are not designed for disassembly before cleaning. To avoid
damage (pitting, rusting), avoid highly aggressive agents (NaOH, NaOCL), and salt solutions.
Surgical instruments should only be used and reprocessed by qualified healthcare practitioners.
Consult the manufacturer’s specifications for detailed instructions.

CONTROLLED

Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 4 of 12

Point of Use:

1. Wipe instruments to remove visible soil.

2. Keep instruments moist, preferably submerged in cold water (<40°C) immediately after use.

Manual Cleaning:

1. Submerge instruments in a pH neutral enzymatic cleaning agent or detergent (pH <8.5)
solution for 10 to 15 minutes. Do not use aldehyde fixating detergents because they can
cross-link the protein residues, making it difficult to remove soiling. Follow detergent
manufacturer's instructions for mixing ratios and temperature.

2. Use a soft bristle brush if needed to remove visible soil from surfaces. Give special attention
to uneven surfaces (such as knurled handles) and drilled holes/cannulation. Use flexible bottle
brush, syringes, or aspiration for hard to reach places such as cannulation.

3. Thoroughly rinse with de-ionized or sterile, purified water, (<40°C), until it is no longer slippery
to the touch, for a minimum of 2 minutes. Use a syringe to apply rinsing solution under
pressure to hard to reach areas such as cannulations and drilled holes.

4. Visually inspect instruments for remaining debris, paying special attention to hard to reach
areas. Repeat rinsing steps if needed until no visible soiling remains.

5. Drain instruments on single-use drying paper or lint-free towel.

Ultrasonic Cleaning:

1. Submerge instrument in ultrasonic bath with pH neutral enzymatic cleaning agent or
detergent, (pH <8.5), solution. Follow detergent manufacturer's instructions for mixing ratios
and temperature.

2. Soak at 25 to 45 kHz for 10 to 15 minutes. Visually ensure complete immersion of
instruments.

3. Thoroughly rinse with de-ionized or sterile, purified water, (<40°C), until it is no longer slippery
to the touch, for a minimum of 2 minutes. Use a syringe to apply rinsing solution under
pressure to hard to reach areas such as cannulations and drilled holes.

4. Visually inspect instruments for remaining debris, paying special attention to hard to reach
areas. Repeat rinsing steps if needed until no visible soiling remains.

5. Drain instruments on single-use blotting paper.

Dry & Inspect Instruments:

1. Thoroughly dry instruments with a soft, lint-free cloth, with single-use drying paper, or with
medical grade, filtered, compressed air. Hard to reach areas such as drilled holes and
cannulations should be dried with medical compressed air.

2. Visually inspect instruments before sterilization. This is typically done under normal lighting
and without magnification.

3. Visually inspect for soiling, corrosion, cracks, and damage to components.

4. Functionally inspect adapters (if equipped) to ensure they connect onto mating shafts. Check
function of ratcheting screwdrivers in both directions, (forward and reverse).

5. Notify appropriate personnel regarding damage and malfunctioning components.

Sterilization:

1. Sterilization testing has been performed in accordance with ISO 17665-1:2006 Sterilization of
Health Care Products – Moist Heat – Part 1 a. Gravity: 250°F, 30 min exposure, 45 min dry
time.

2. After dry time allow a minimum of ten minutes for equilibration period to allow instrument to
cool to room temperature.

Cleaning:
Automated

Instruments and trays should be washed separately. A wire basket provided by the mechanical
washer manufacturer may be used to hold loose instruments and component devices. All design
features must be accessible for cleaning and positioned to assist with drainage where liquid may
settle. For example, cannulations and blind holes should be inclined downwards and hinges should be
open to assist with drainage. Avoid overloading the wire baskets and washer. Process the devices
using the following parameters.

CONTROLLED

Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 5 of 12

Step

Cleaning Instructions

Minimum

Duration of Time

(if applicable)

Water Type and

Temperature

(if applicable)

Pre-wash

Clean device with cold water for 2 minutes.

2 minutes

Cold water

Enzymatic

Wash

Wash with a solution of warm (55°C) cleaning
detergent* for 5 minutes.

5 minutes

Warm water

(55°C)

Rinse

Rinse with cold demineralized (DI/PURW) water for 5
minutes.

5 minutes

Cold DI/PURW

water

Thermal

Disinfection

Automated Thermal Disinfection in washer/disinfector
under consideration of national requirements in
regards to A0-Value (See ISO 15883).

N/A

N/A

Drying

Drying has been achieved when no residual water can
be detected at the end of the drying stage.

N/A

N/A

*Follow the detergent manufacturer’s recommendations for the correct dilution, temperature, contact
time and water quality for the detergent. A summary of the cleaning validation is included in the
Additional Information section.

Inspection

Instruments, implants and trays should be inspected for cleanliness prior to sterilization. Actuate any
movable or hinged parts for thorough inspection. Repeat the provided cleaning steps until instruments
and cases are free of any visible debris and moisture.

Implants and instruments are to be examined by hospital trained personnel for functional integrity,
corrosion and damage (proper assembly, scratches and dents, material residue, discoloration,
impurities, etc.). Damaged devices, those with unrecognizable markings, signs of corrosion or dull
edges should not be used and must be properly cleaned, sterilized and returned to Medtronic.

A thorough inspection of the Aesculap® SterilContainersTM and its components must be conducted
prior to every use to ensure proper performance per the manufacturer’s specifications. If the
Aesculap® SterilcontainerTM is damaged, DO NOT USE TO STERILIZE PRODUCT. Notify a
Medtronic representative and return the cleaned and sterilized container to Medtronic.

Maintenance

Lubrication

Hospital trained personnel must lubricate any moving parts, such as hinges, joints, spring loaded
bearings, or threads on instruments after disassembling and cleaning. Neutral pH lubricants are
recommended. Mineral or oil-based lubricants should never be used, as steam cannot penetrate
mineral oils and instruments may not achieve sterility.

Lubrication is required for proper functioning of devices. On the Endoskeleton™ TAS and TCS Fixed
Angle Drivers (P/Ns 2300-1313, 2300-1322 & 5210-1067), ensure thorough lubrication where lock
nut/pin rotates on the inner shaft and on drive gears. On the Endoskeleton™ TAS Quick Inserter (P/N
2300-1312), the linear motion threads, lubrication ports, adjustment tabs and blade hinge area must
be kept well lubricated. Lubricate prior to assembly and use. Below are examples of common
lubrication points:

Hinges and Sliders:

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Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

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Moving and
Rotating
Mechanisms:

Mating
Components:

Packaging

Reassemble instruments prior to sterilization unless otherwise designated by the sterilization tray
configuration. If reassembly is required, instructions are as indicated in product specific instructions or
as described in the Additional Information section of this document.

Place clean, dry devices into their designated brackets within a Titan tray using the product images
and product identifiers on the tray as a guide. Trays and their components are designed to weigh 25
lbs or less for ease of handling and reprocessing. If instruments are added to the tray at the hospital,
the user is responsible for validation of the new layout.

Chemical and biological indicators may be used to for verification or validation at the customer facility.
It is recommended that the indicators be placed throughout the tray, especially in dense, tightly
packed areas of the tray, such as in caddies or in the bottom of the tray.

Aesculap® SterilContainerTM:
Follow the container manufacturer’s specifications for detailed instructions. Place one sheet of the
Aesculap (US751) filter paper over each perforated section on the inside of the lid. Be sure indicator
dot faces toward the inside of the container when the lid is in place and that the indicator dot is visible
through the retention plate on the inside of the lid. Secure each filter with the retention plate designed
for use with the container lid. Place assembled instrument tray(s) into the prepared container bottom.
Place inner lid on top of the tray and lock into position. Place assembled lid onto the container bottom,
align handles on bottom with latches on lid. Simultaneously close both locking latches on the lid.

Perforated (Non-Rigid) Container:

Double wrap cases in a sterile packaging barrier (FDA-cleared sterilization wrap is recommended).
Place implants and instruments in cases in such a way that they will not damage the sterile barrier or
other instruments.

Sterilization

Aesculap® SterilContainerTM:

The container should be placed flat for effective sterilization and positioned per the sterilizer
manufacturer’s guidelines for optimum sterilization conditions. External stacking is not recommended.
Processing Aesculap® SterilContainersTM:
Run the sterilizer using the following sterilization cycle:

Cycle

Instructions

Method

Steam

Cycle

Pre-vacuum

Temperature

134°C (273°F)

Exposure time

3 Minutes

Minimum Dry Time**

30 Minutes

CONTROLLED

Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 7 of 12

At completion of the cycle, the sterilizer door may be opened approximately 6” and left open for a
period of 15 minutes to aid in drying, or as recommended by the sterilizer manufacturer.
The container needs to remain on the container cart, in a draft free area, until cool enough to handle.
Cooling in a draft-free area minimizes the formation of condensation on the inside of containers. If
condensation on the inside of containers comes into contact with the outside contaminants, sterility
may be compromised.

Perforated (Non-Rigid) Containers

The following parameters were validated for sterilizing
implants, instruments and cases within a sterile
barrier packaging system. Do not exceed an 18-minute
hold time during sterilization. External stacking is not
recommended.

The following sterilization cycles (in accordance with ANSI/AAMI ST79 or ISO 14937 and ISO 17665-

1) are recommended for use with FDA-cleared sterilization wraps:

Surgical

Case

Method

Cycle

Temperature

Minimum Exposure

Time

Minimum Dry

Time**

Wrapped

Steam

Pre-Vacuum

132°C (270°F)

4 minutes

40 minutes

Wrapped*

Steam*

Pre-Vacuum*

134°C (273°F)*

3 minutes*

40 minutes*

Wrapped

Steam

Pre-Vacuum

135°C (275°F)

3 minutes

40 minutes

*For use outside USA only
**Drying times may vary due to different packaging methods (sterile barrier system, reusable
sterilization container, etc.), steam quality, product material, weight, sterilizer performance, variable
cooling, etc. Health Care facilities are responsible for following validated cleaning methods to ensure
safe handling and decontamination has been achieved. If any moisture is observed, the set must be
considered contaminated and reprocessed per ANSI/AAMI ST79. Manufacturer and distributor
assume no liability for the sterilization of the product carried out by the customer which have not been
performed according to the recommended parameters.

Storage

Store sterile devices in a cool, dry place. The environment should be free from dust, moisture or
extreme temperature or humidity. Use products in the order of “first-in, first-out.” Follow the
sterilization wrap manufacturer’s or the rigid container manufacturer’s IFU indications for event and/or
time related restraints on sterility maintenance.

Additional
Information

Validation Information:

The following supplies were used during validation of these reprocessing instructions. Enzol®
Solution was utilized in cleaning validation activities and determined to be capable of effectively
cleaning a non-sterile Titan devices. A 7-minute dry time was utilized after automated washing. The
sterilization validation was conducted in an empty sterilizer chamber using a PRIMUS Sterilizer (Model
#PSS8-A-MSSD) and FDA-cleared Halyard Health Sterilization Wrap (H600).

[space intentionally left blank]

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Type:

Training Document

Title:

Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 8 of 12

Disassembly Instructions:
Endoskeleton™ TAS

The Endoskeleton™ TAS Fixed Angled Driver (P/N 2300-1313) must be disassembled for cleaning,
as shown in the image below. Unthread the inner shaft from the outer body by turning the knob
counterclockwise. Then, remove the driver/drill tip from the outer body by sliding the outer sheath
away from the tip of the driver and turning the driver. Reassembly is completed by reversing the steps
described for disassembly.

The Endoskeleton™ TAS Cage Quick Inserter (P/N 2300-1312) must be reassembled for use, as
described in the steps and images below. The instrument is disassembled for cleaning by reversing
the steps described below.

Step 1: Assemble the Inner Shaft into the distal end of the Outer Body by first spreading the spring­loaded Blades. Then, insert and thread the Inner Shaft counter-clockwise:

Step 2: Take care to ensure proper orientation of the Inner Shaft with respect to the blades. The
Vertebral Body Stop Features of the Inner Shaft go through the Blade Channels, as shown below.
Note the lasermarking note.

Step 3: Attach the ¼” Square connect Ratcheting T-handle to the back of the Quick Inserter:

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Document No. 70-0015

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The Endoskeleton™ TAS Anterolateral Inserters (P/Ns 2300-1303, 2300-1304, 2300-1305, 2300-
1318, 2300-1319, & 2300-1320) must be reassembled for sterilization, as shown in the steps and
images below. The instrument is disassembled for cleaning by reversing the steps described below.
Each Inserter consists of 3 subcomponents to allow for cleaning and sterile processing. The 3
subcomponents are:

Outer Body:

Inner Shaft:
Inner Tip:

Step 1: Assemble the Inner Shaft to Inner Tip by threading the male threaded end of the Inner Tip into
the female thread of the Inner Shaft. Ensure it is finger-tight to keep it from rotating during assembly
with Outer Body in next step.

Step 2: Insert Step 1 assembly into Outer Body. Look down lumen of Outer Body to ensure the “Hook”

of the Inner Tip is oriented correctly as it advances.

Note Inner Tip Orientation while advancing
assembly through Outer Body (left) is correct.

Step 3: Thread the knurled knob
clockwise until finger tight to secure
Inner Shaft assembly into the Outer
Body. When assembled properly,
note no gap between the shoulder
of the Outer Body and the face of
the knurled knob.

Step 4: Test assembly by rotating back knob clockwise and counter clockwise to ensure linear travel

of assembly.

No gap Knurled knob

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Reprocessing Instructions for Titan Devices

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Endoskeleton™ TC

The Endoskeleton™ TC Inserter (P/N 5200-1001) must be disassembled for cleaning, as shown in

the image below. Thread the locking nut into the unlocked position. Unthread the collar from the outer

body, then remove the outer body from the inner shaft. The instrument may be reassembled for

sterilization by reversing the steps described above.

Endoskeleton™ TT

The Endoskeleton™ TT Articulating Inserter (P/N 4200-1046) must be reassembled for use, as

described in the steps and images below. For cleaning, the Inserter should be disassembled by

reversing the steps described below. For disassembly, note in step 2, “Release Angle” button must

be pushed and held while turning Knob clockwise to begin unthreading Knob from Outer Body.

Each Inserter consists of 3 subcomponents to allow for cleaning and sterile processing. The 3

subcomponents are:

Outer Body:

Inner Shaft:

Knob:

Step 1: Assemble the Knob to the Outer Body by holding down the “Release Angle” button while

inserting the tip end of the Outer Body shaft into the back end of the Knob.

When assembling, note inner geometry of Knob in
relation to Outer Body Tip. The Outer Body tip is
highlighted in the images below. Components must be
in correct orientation to slide the Knob onto the Shaft.

Depress “Push” Button and ensure the sliding shaft is

in the “straight” position before sliding onto the Knob.

Correct

Incorrect

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Document No. 70-0015

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Step 2: Slide Knob onto Outer Body Shaft. When it hits the threads rotate the Knob counterclockwise

to thread onto the Outer Body. The Knob is designed to fit onto the threads in only one orientation, with

the “Release Angle” button and “0, 20, 40” degree markings facing the same direction, as shown below.

Once Knob is inserted to the position shown, rotate
counterclockwise to engage threads. Inserter tip
will be in the starting position (0°) once a hard stop
is felt. Note the line on the Knob and the “0” on the
shaft will align.

Step 3: Assemble the Inner Shaft to the Outer Body by holding the “Push to Clean” button and

inserting the Inner Shaft through the back end of the Outer Body.

References

AAMI TIR 12: Designing, testing, and labeling reusable medical devices for reprocessing in health

care facilities: A guide for medical device manufacturers

AAMI TIR 30: A compendium of processes, materials, test methods, and acceptance criteria for

cleaning reusable medical devices

ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care

facilities

ISO 14937: Sterilization of health care products – General requirements for characterization of

sterilizing agent and the development, validation and routine control of a sterilization process for

medical devices

ISO 15883: Washers – disinfectors

ISO 17664: Processing of health care products

ISO 17665: Sterilization of health care products

Engineering Report: 09-0107 Steam Sterilization Validation of Endoskeleton Instrument and Implant

Sets in Reusable Rigid Container Systems

Engineering Report: 09-0317 Steam Sterilization Validation of Wrapped Endoskeleton™ Systems

Engineering Report 09-0239 Endoskeleton™ TT Instrument Cleaning Validation – Simulated Use

Aesculap® SterilContainerTM System Instructions for Use (SOP-AIC-5001592 – February 2018)

Bradshaw Medical, Inc. 2nd Gen. Axial Torque Limiting Driver IFU (Form 7.2.2-17 Rev. 0 – 8/30/2018)

MedTorque, Inc. Instructions for Use (IFU) Torque Limiting Drivers (IFU-002 Rev. C)

Manufacturer

Contact

For further information, contact:

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place

Memphis, Tennessee 38132

Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

Rotate to Thread

Knob fits onto threads with release angle button and angle markings on the same side

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Reprocessing Instructions for Titan Devices

Document No. 70-0015

Revision No. 16

DCR No. 5520

Proprietary and confidential property of Medtronic

Page 12 of 12

Date issued: 5/20/2020