1:Stealth Autoguide™ II Sterilization Tray (9736377)
Stealth Autoguide™ Reusable Devices Cleaning and
Sterilization
Intended use
The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial
positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to
guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an
image guided navigation system with three-dimensional imaging software.
The Stealth Autoguide
™
reusable devices are intended for use with the Stealth Autoguide™ System.
Product description
The Stealth Autoguide™ System consists of a surgical trajectory platform and procedural specific
accessories. The products work together to create a complete procedural solution for trajectory
alignment.
Stealth Autoguide™ reusable devices
Common devices
• Stealth Autoguide™ Tracker (28248)
• Autoguide Tapping Tube (31527)
• Legend™
Note:
• Autoguide Lower Guiding Insert (28249)
• Autoguide Upper Guiding Insert (27586)
• Autoguide Guiding Joint (27584)
Biopsy / sEEG devices
• Autoguide Stab Incision Height Guide (27563)
• Autoguide Stab Incision Obturator (28340)
• Autoguide Stab Incision Drill Guide (28326)
• Autoguide Stab Biopsy, 2.2 mm Reducing Tube (28330)
Depth Stop Attachment (ASDS01)
For cleaning of the Legend™ Depth Stop Attachment (ASDS01), refer to the instructions
for use that accompany the device.
• Autoguide Burr Hole Drill Guide (28322)
• Autoguide Burr Hole 2.2 mm Reducing Tube (28334)
• Autoguide sEEG Reducing Tube (one of the following):
- Autoguide sEEG, 2.4 mm Reducing Tube (28336)
Autoguide sEEG, 2.5 mm Reducing Tube (9736381)
-
• Autoguide sEEG, 4.0 mm Reducing Tube (28328)
• Autoguide sEEG, Drill Guide (9736380)
Visualase™ devices
• Autoguide Visualase™ Height Guide (27565)
• Autoguide Visualase
• Autoguide Visualase
• Autoguide Visualase
™
Obturator (28338)
™
Drill Guide (28324)
™
1.7 mm Reducing Tube (28332)
Potential complications
Medtronic has identified potential complications for users related to cleaning and sterilization of the
Stealth Autoguide
limited to:
Pain, infection, edema, tissue or bone damage, bleeding, nerve damage
™
System reusable devices. These potential complications include, but are not
Warnings
Warning:
Warning:
Warning:
Warning:
Warning:
Warning:
Prior to use, examine the product packaging and the product itself for damage,
deterioration, or abuse. Do not attempt to use any device that appears to be bent or otherwise
damaged. Abandon the use of any device damaged during the procedure. See the
“Maintenance Inspection Testing” instructions in this document to determine if the device is
suitable for use. If defects are found, do not use the product. Contact the device manufacturer.
The sterilizable devices of the Stealth Autoguide™ System are designed for reuse and
are supplied in non-sterile condition. Clean and sterilize the devices prior to use.
Place only the specified devices in the rigid sterilization container. Placing additional
items in the rigid sterilization container affects sterilization efficacy and dry time.
Use Personal Protective Equipment (PPE) as necessary when handling, processing, or
disposing of the device. Universal precautions should be observed by all personnel according
to OSHA Standard 29 CFR 1910.1030 Occupational Exposure to Blood Borne Pathogens.
Do not reuse or reprocess any device where spongiform encephalopathies or
Creutzfeldt-Jakob disease contamination is suspected. Incinerate the potentially contaminated
device according to national guidelines.
To prevent cross-contamination, always handle, transport, and reprocess devices
contacting the central nervous system separately from other devices.
Precautions
Caution:
Caution:
Caution:
Federal law (U.S.A.) restricts this device to sale by, or on the order of, a physician.
For health care facilities outside the U.S.A. and its territories, follow EN ISO 15883-1 for
load and thermometric settings for all washer/disinfector machines.
Do not use corrosive agents unless included in the recommendations.
Compatibility
For sterilization and storage of the Stealth Autoguide™ reusable devices, use the Stealth
Autoguide
inner tray includes graphical outlines of the devices and corresponding part numbers.
™
sterilization container (part number 31814 or 9736377). The sterilization container’s
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Material composition
Material contained in product that can cause an allergic reaction: Nickel
System level manual
The Stealth Autoguide™ reusable devices are used with the Stealth Autoguide™ System. See the
Stealth Autoguide
intended user profiles, intended patient population, clinical benefits, side effects, and potential
complications.
™
System Manual for descriptions of indications for use, contraindications,
Reprocessing instructions
Cleaning is the removal of organic soil. Effective cleaning accomplishes the following:
• Minimizes the organic soil transfer from one patient to another.
• Prevents accumulation of residual soil throughout the product’s useful life.
• Allows for successful sterilization. Sterilization is contingent upon the thoroughness of cleaning.
Cleaning is the initial step and sterilization occurs after cleaning is complete. Sterilization is
intended to kill microorganisms to reduce the likelihood of transmission and possibilities of infection.
To ensure acceptable reprocessing, there should be no delay between cleaning, inspection, and
sterilization.
Use the following instrument lumen measurements to determine lumen brush sizes for cleaning:
Instruments
Autoguide Stab Incision Drill Guide (28326) 4.1 mm × 28.0 mm (tip)
™
Autoguide Visualase
Autoguide Burr Hole Drill Guide (28322) 7.9 mm × 97.9 mm
Autoguide sEEG Drill Guide (9736380) 4.1 mm × 28.9 mm (tip)
Autoguide Visualase
Autoguide Stab Biopsy 2.2 mm Reducing Tube (28330) 2.2 mm × 70.1 mm
Autoguide Burr Hole 2.2 mm Reducing Tube (28334) 2.2 mm × 76.4 mm
Autoguide sEEG 2.4 mm Reducing Tube (28336) 2.4 mm × 77.5 mm
Autoguide sEEG 2.5 mm Reducing Tube (9736381) 2.5 mm × 77.5 mm
Autoguide sEEG 4.0 mm Reducing Tube (28328) 4.0 mm × 77.5 mm
Limitations on
reprocessing
Point of use Reprocessing begins at the point of use. Reprocess the device within 30
Drill Guide (28324) 5.3 mm × 41.3 mm (tip)
™
1.7 mm Reducing Tube (28332) 1.7 mm × 76.4 mm
End of useful life is normally determined by wear and damage due to use.
See the “Maintenance Inspection Testing” section in this document to determine if the device is at the end of its useful life.
Caution: At the end of its useful life, dispose of the device in accordance
with national regulations.
minutes of use. Do not allow blood, debris, or bodily fluids to dry on the
device. Remove excess soil using running, cold tap water 10 – 22°C (50 –
72°F). Tap water is defined as potable water with a hardness value of
<150 mg/l.
Lumen measurements (diameter
× length)
7.9 mm × 69.8 mm (shaft)
7.9 mm × 108.2 mm (shaft)
7.9 mm × 68.8 mm (shaft)
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Containment
and
transportation
Preparation for
Cleaning
Caution: Devices should be cleaned within 30 minutes of use to limit fixa-
tion of contaminants.
If the device cannot be reprocessed immediately, keep the device moist
during transport.
To prolong the life of the device, reprocess immediately after use.
Instruments:
Caution: Do not remove the retaining ring on the outside of the height
guides or on the inside of the lower guiding insert. Removing the retaining ring renders these devices unusable.
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1. Remove the single-use spheres from the Stealth Autoguide
Tracke r
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.
™
2. You may remove thumbscrews from the Stealth Autoguide
Tracke r
(28248), the 2.2 mm reducing tubes (28334 and 28330), the 1.7 mm
reducing tube (28332), and the lower guiding insert (28249). The
2.4 mm and 4.0 mm reducing tubes (28336 and 28328) do not have
thumbscrews.
a. To remove the thumbscrews, fully loosen the screw until it comes
free from the device.
b. Take care to retain thumbscrews.
3. Thoroughly rinse the device under running cold tap water at a temperature of 10 – 22°C (50 – 72°F) to remove any visible soil.
4. Use a soft-bristled brush or clean cloth to aid soil removal. Give particular attention to lumens, crevices, thumbscrews, thumbscrew holes,
and other areas that present a challenge to cleaning.
5. Use a lumen brush, cleaning stylet, or pipe cleaner to clean the reducing tube and drill guide lumens.
6. Carefully inspect devices, including any lumens, thumbscrews, thumbscrew holes, and cavities, to ensure all visible soil is removed.
7. Reassemble the thumbscrews to the reducing tubes and the Stealth
Autoguide
™
Tracker by threading the thumbscrews into the devices.
Warning: If a reducing tube or a drill guide is obstructed with bone or other
tissue, use caution as injury may occur while trying to remove the
obstruction.
Reducing tubes and drill guides have the potential to accumulate bone and
other tissue in the lumen. If the obstruction cannot be removed from the
lumen, the device is considered to be at the end of its useful life. Dispose of
the device according to national regulations.
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Automated
cleaning
Caution: Use the rigid sterilization container for sterilization only, not for
cleaning or disinfection.
Instruments:
1. Prior to placing the device into the washer, thoroughly rinse the device
under running cold tap water 10 – 22°C (50 – 72°F) to remove any visible soil.
2. Use a soft-bristled brush for exterior cleaning and an appropriate
lumen brush for interior cleaning to aid in the removal of soil. Give particular attention to crevices, lumens, and other hard-to-clean areas to
remove all visible soil. Carefully inspect the devices, including lumens
to ensure all visible soil is removed.
™**
3. Prepare a neutral enzymatic cleaner such as Steris Prolystica
2x
Concentrate Enzymatic Cleaner following the manufacturer’s recommendations of 1.0 mL/L (1/8 oz/gal) at a temperature of 23 – 30°C (73
– 86°F), or use an equivalent neutral pH enzymatic cleaner following
that manufacturer’s recommendations.
4. Using a syringe, repeatedly flush lumens, until the solution runs clear.
Allow cleaner solution to reach hard-to-clean areas.
5. Transfer the devices to the washer, and select the instrument cycle.
Ensure the cycle parameters for either neutral pH enzymatic cleaner or
alkaline detergent are properly programmed.
Neutral wash cycle parameters for reusable Stealth Autoguide™
devices
Phase Recirculation/
soak (minutes)
Prewash 1 2 minutes
(02:00)
Water temperature
Cold tap water
10 - 22°C
Cleaner type
N/A
(50 - 72°F)
Enzyme Wash 2 minutes
(02:00)
Hot tap water
43 - 55°C
(109 - 131°F)
Steris Prolys-
™**
2x Concen-
tica
trate Enzymatic
Cleaner, 1.0 ml/L
(1/8 oz/gallon), or
equivalent neutral
pH enzymatic
cleaner
Wash 1 2 minutes
(02:00)
66°C (151°F)
(setpoint)
Steris Prolys-
™**
2x Concen-
tica
trate Neutral
Detergent 1.0 ml/L
(1/8 oz/gallon), or
equivalent neutral
pH detergent
Rinse 1 15 seconds
(00:15)
Hot tap water
43 - 60°C
N/A
(109 - 140°F)
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Automated
cleaning
continued
Thermal Rinse 1 minute
(01:00)
Purified Water
Rinse
10 seconds
(00:10)
90°C (194°F)
(setpoint)
66°C (151°F)
(setpoint)
N/A
N/A
Alkaline wash cycle parameters for reusable Stealth Autoguide
™
devices – alkaline detergent (working solution pH 8.0- 11.2 pH)*
*Alkaline detergent manufacturers provide concentrated alkaline detergents. The alkaline detergents must be diluted per the detergent manufacturer's instructions. Medtronic has verified alkaline detergent compatibility
for working solutions up to 11.2 pH.
Phase Recirculation/
soak (minutes)
Pre-wash 2 minutes
(02:00)
Water temperature
Cold tap water
10 - 22°C
Detergent type
N/A
(50 - 72°F)
Wash 5 minutes
(05:00)
Hot tap water
43°C (109°F)
(target)
Alkaline detergent
such as Dr. Weigert neodisher
SeptoClean,
3 mL/L (3/8 oz/gal)
Rinse 1 minute
(01:00)
Hot tap water
43 - 60°C
N/A
(109 - 140°F)
Thermal Rinse 1 minute
(01:00)
Purified Water
Rinse
1 minute 30 seconds
90°C (194°F)
(setpoint)
66°C (151°F)
(setpoint)
N/A
N/A
(01:30)
Warning: After cleaning, visually examine all parts of the device for cleanli-
ness. If visible soil remains, repeat cleaning.
Drying If necessary, dry the device with a clean, lint-free towel or clean/filtered
compressed air.
™**
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Maintenance
inspection
testing
Instruments:
Visually inspect each instrument following cleaning. Inspection should be
performed with adequate lighting. Magnification is not required. A device
that shows or exhibits the properties listed below is at the end of its useful
life. Dispose of the device according to national regulations.
• Obvious damage or corrosion
• Pitting, cracks, fractures, or bending
• Illegible laser etchings, engravings, and other markings
• Discoloration, corrosion, stains, or rust
• Damaged or stripped threads
• Dull or damaged sharp edges
• Damaged bearings
• Separation of joints
Warning: Do not reprocess for surgical use a device that has obvious dam-
age or corrosion.
Warning: Replace any device that appears to be damaged because a dam-
aged device may cause inaccuracy or patient harm.
Packaging The user facility is responsible for using only accessories (such as chemical
indicators and biological indicators) that are cleared and labeled for the validated sterilization parameters specified in this document by the Food and
Drug Administration for health care facilities in the U.S.A. and its territories,
or conform to EN ISO 11607 for health care facilities outside of the U.S.A.
and its territories.
™**
Sterilize instruments in the rigid SteriTite
sterilization container (part num-
ber 31814) with SCF01 paper filters.
™**
Follow the instructions that accompany the SteriTite
sterilization container
to prepare the container for sterilization.
™**
Arrange the clean devices in the inner tray of the SteriTite
sterilization
container. The tray includes printed outlines and part numbers of the
devices that fit within the tray.
Warning: Place only the specified devices in the inner tray. Placing addi-
tional items in the container affects sterilization efficacy and dry time.
Sterilization Warning: Do not wrap the container. Devices cannot be sterilized to an ade-
quate Sterility Assurance Level (SAL) if the container is wrapped.
Warning: The recommended sterilization parameters are only valid with
properly maintained and calibrated equipment that is cleared by the
Food and Drug Administration for health care facilities in the U.S.A. and
its territories or CE marked for health care facilities outside the U.S.A.
and its territories.
Warning: Steam for sterilization should be generated from water that has
been treated to remove total dissolved solids, filtered to remove contaminants and water droplets, and supplied via piping without deadlegs
or other stagnant zones where contamination might collect. Steam saturation should be greater than 97%.
Caution: Use the rigid sterilization container for sterilization only. Instru-
ments must be cleaned separate from the container.
Caution: Devices cannot be sterilized to an adequate Sterility Assurance
Level (SAL) without prior cleaning.
7
Sterilization
continued
Storage Make sure that the container is dry before storage, and stored in cool, dry
The reusable Stealth Autoguide™ devices are validated for steam sterilization (moist heat) only.
1. Load the container into the sterilizer following the sterilizer manufacturer’s load procedures and load configurations.
2. Program the sterilizer using either the parameters below for health
care facilities inside the U.S.A. and its territories or for health care facilities outside the U.S.A. and its territories.
Sterilization cycle parameters – Steam (moist heat) method
Health care facilities inside the U.S.A.
Cycle Temperature Exposure time Minimum dry
time*
Prevacuum 132°C
(270°F)
Prevacuum 135°C
(275°F)
*Minimum dry times were validated using sterilizers having vacuum drying
capabilities. Drying cycles using ambient atmospheric pressures may
require more time.
Health care facilities outside the U.S.A.
Cycle Temperature Exposure time Minimum dry
Prevacuum 132°C
(270°F)
Prevacuum 134°C
(273°F)
Prevacuum 135°C
(275°F)
Prevacuum 134°C
(273°F)
*Minimum dry times were validated using sterilizers having vacuum drying
capabilities. Drying cycles using ambient atmospheric pressures may
require more time.
conditions at ambient room temperature. Store sterile devices in such a way
that the sterile package is not compromised.
4 minutes
(04:00)
3 minutes
(03:00)
4 minutes
(04:00)
18 minutes
(18:00)
3 minutes
(03:00)
3 minutes
(03:00)
30 minutes
(30:00)
30 minutes
(30:00)
time*
30 minutes
(30:00)
30 minutes
(30:00)
30 minutes
(30:00)
30 minutes
(30:00)
Instructions for use
When you are ready to use the sterilized container, follow these steps.
1. Before you open the container, make sure that:
• You have selected the correct device container.
• The tamper-evident seals are intact.
• The external chemical indicators have changed color to indicate that the container was steam
sterilized.
2. Break the tamper-evident seals and discard them.
3. Unlatch the container.
4. Use the rings on top of the lid to remove the lid.
Using the rings avoids contaminating the container’s contents.
8
5. Make sure that the internal chemical indicator has changed color to indicate that the container
was steam sterilized.
6. Remove the tray of devices and place it in the sterile field.
7. Refer to the Stealth Autoguide
devices in a clinical procedure.
™
System Manual for detailed instructions on use of the individual
Contact information
If a serious incident occurs in relation to the use of this device, report it to Medtronic Navigation. If
this incident occurs in the European Union, also report it to the competent authority in the Member
State where the incident occurred.
Assistance
If you have questions about the reusable Stealth Autoguide™ devices, contact Medtronic
Navigation, Inc. for technical support. In the U.S., call 1 800 595 9709; outside the U.S., call
+1 720 890 3160.
™**
Third party brands are trademarks of their respective owners. All other brands are trademarks of
a Medtronic company.
Symbol definitions
The following symbols may appear on the device packaging:
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician.
Medical device
Importer
9
Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville, Colorado 80027
USA
Main 720 890 3200
Fax 720 890 3500
Technical Support
U.S. 1 800 595 9709
International 1 720 890 3160
www.medtronic.com
www.manuals.medtronic.com
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
Netherlands
Telephone 31 45 566 80 00
©2021 Medtronic Navigation, Inc.
All Rights Reserved
9736152
D00567542 Revision A
00763000616151
2021-12
Australia
Medtronic Australasia Pty Ltd
2 Alma Road
Macquarie Park, NSW 2113
1800 668 670
Printed in the USA
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