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EM200N
Quick Guide
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Medtronic EM200N Instructions for Use

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Electric Stealth-Midas™ System
Model: EM200N
User’s Guide
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The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Midas Rex®, Stealth-Midas™, StealthStation™, IPC™, ClearView™, Legend™, Synergy™, and O-arm™. All other trademarks, service marks, registered trademarks or registered service marks are the property of their respective owners in the United States and other countries.
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Contents
Glossary ...................................................................................................................................................................................... 3
Indications for use .................................................................................................................................................................. 3
Device description .................................................................................................................................................................. 3
Warnings .................................................................................................................................................................................... 3
No Latex Policy ....................................................................................................................................................................... 3
Electric Stealth-Midas motor .............................................................................................................................................. 3
Dissecting tools and attachments .................................................................................................................................... 5
Navigation ................................................................................................................................................................................. 9
Troubleshooting ....................................................................................................................................................................15
Cleaning and sterilization .................................................................................................................................................. 16
Preventative maintenance ................................................................................................................................................ 18
Limited warranty ................................................................................................................................................................... 18
Symbols .................................................................................................................................................................................... 19
Instrument management: Adding Stealth-Midas to a procedure .................................................................10
Verifying the Stealth-Midas .........................................................................................................................................11
Starting navigation ......................................................................................................................................................... 13
Projecting ........................................................................................................................................................................... 13
Selecting tip ......................................................................................................................................................................13
Changing views ................................................................................................................................................................14
Planning .............................................................................................................................................................................. 14
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Glossary
Dissecting tool Disposable cutting tool that connects to Stealth-Midas motor
IPC Integrated Power Console, used to power the Electric Stealth-Midas motor
Tool list List of navigable items in StealthStation software
Indications for use
The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identied relative to a CT- or MR-based model, uoroscopic images, or digitized landmarks of the anatomy.
Device description
The Stealth-Midas is a powered drill that will remove soft tissue, hard tissue, bone, and biomaterials during surgical procedures. The permanently attached tracker will allow for intraoperative navigation of spinal procedures using the StealthStation. This device is intended for use by physicians trained in the procedures described.
Warnings
W1 It is important that the Stealth-Midas system operator be familiar with the system User’s Guide, its precautions, procedures and safety issues. W2 The Stealth-Midas system and its associate applications should be used only by qualied medical professionals who are thoroughly trained and experienced
in performing surgery with Medtronic computer-assisted surgery systems.
W3 The Stealth-Midas system and its associated applications should be used only as an adjunct for surgical guidance. It is not a replacement for the surgeon’s
knowledge, expertise, or judgment.
W4 Do not place Electric Stealth-Midas handpiece in the proximity of magnetic eld, such as magnetic drape and MRI equipment, to avoid inadvertent
handpiece activation.
W5 Ensure that the Reference Frame is properly secured to anatomy before navigating. Neglecting to verify that the Reference Frame is secured could result in
navigational inaccuracy if the hardware moves in relation to the anatomy after registration is complete. W6 Operate the Stealth-Midas only after appropriate anatomical landmarks and the intended surgical site have been conrmed. W7 During navigation and after decompression and/or distraction, frequently conrm navigational accuracy by touching the tip of the Stealth-Midas on known
anatomical points and comparing the position of the Stealth-Midas tip in the image with its physical location. W8 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. W9 Heavy side loads and/or long operating periods may cause the device to overheat. W10 Always secure the secondary lock to eliminate motion between the dissecting tool and the tracker, which could impact navigation accuracy. W11 The Stealth-Midas Motor should only be operated when the attachment is in the locked position. W12 DO NOT verify the handpiece for navigation with the handpiece running to prevent device damage or deposit metal shavings on the surgical site. W13 The Stealth-Midas is a precision surgical instrument. With precision instruments, excessive force, beyond the design strength of the instruments, can be
caused by even simple manual overloading. W14 Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. W15 Carefully inspect dissecting tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any
suspicious dissecting tools with a new one prior to use. W16 Use only dissecting tools specically designed for use with this drill system. Match the nomenclature and color code on the tool packaging to the same
nomenclature and color code on the attachment. Conrm that the dissecting tool packaging label has the Stealth-Midas logo ( ) if
navigation is required. W17 Do not use the Stealth-Midas system before proper cleaning and sterilization. W18 The tracker is permanently axed to the Stealth-Midas motor and should not be removed at any time. W19 If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system. W20 Always re-verify the Stealth-Midas in the software when changing dissecting tools, attachments, or attachment orientation. W21 Clinical Navigation Software Application prevents the simultaneous localization with multiple trackers with incompatible geometries. Use only one
Navigated Stealth-Midas Motor per procedure. W22 Do not apply force when verifying dissecting tools. W23 Refer to the IPC Instructions for Use, Clearview Insert, and Synergy Spine & Trauma Pocket Guide for additional instructions, warnings, and cautions.
No Latex Policy
Medtronic Powered Surgical Solutions guarantees that all Stealth-Midas, Legend equipment and products identied in this manual manufactured by and/or for Medtronic Powered Surgical Solutions do not contain latex. Medtronic Powered Surgical Solutions’ packaging materials, labels, pouches, package inserts or similar items do not contain latex.
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Electric Stealth-Midas motor
Components
The Electric Stealth-Midas motor (Figure 1) is a high speed, high torque, navigable electric motor used to dissect bone and biomaterial at selectable speeds from 200 to 75,000 rpm. The following instructions for the Electric Stealth-Midas are in addition to the general assembly instructions found in the IPC instructions for use. Complete IPC setup, then continue to the instruction below.
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Electric Stealth-Midas
1. IPC connection
2. Cable
3. Tracker
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1. Electric Stealth-Midas motor connection ports
2. Multifunction foot pedal connection port
IPC Connector Panel
4. Secondary lock
5. Collet
Connection to IPC
Locate the Electric Stealth-Midas connection port on the IPC connector panel (Figure 2) and insert the connector. Note: Refer to IPC Instructions for Use for more detailed instructions on operation of IPC and touch-screen.
Technical specications
Electric Stealth-Midas Motor EM200N
Size 17.4 cm Length x 1.65 cm Diameter
Weight 130g
Speed 75,000 rpm Forward/Reverse
Duty Cycle for Applied Part For use in operating room temperatures up to 40°C (104°F), the Electric Stealth-Midas motor is rated for 3 minutes at 60,000 rpm
followed by 25 minutes of rest.
For normal operating room temperatures (typically 20°C/68°F), the Electric Stealth-Midas motor is rated for cutting indenitely at 60,000 rpm.
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Dissecting tools and attachments
Straight attachment assembly
Caution: Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment. Conrm that the dissecting
tool packaging label has the Stealth-Midas logo ( ) if navigation is required.
Notes:
• An attachment will not seat on the motor if the arrows on the collet ats are not in alignment.
• The Electric Stealth-Motor will not run properly unless the attachment is in the locked position.
• Conrm that the dissecting tool packaging label has the Stealth-Midas logo (Stealth-Midas) if navigation is required.
• Smoke and/or excessive heat may be generated if the attachment is not in the fully locked position. This may result in thermal injury to the surgeon or sta.
1. Slide a straight attachment over the motor collet aligning triangular arrows on the attachment and the motor case (Figure 3). An audible click, heard and
perceptible by touch, conrms that the attachment is fully seated.
2. Insert the tool into the attachment with a slight rotational motion (Figure 4). An audible click, heard and perceptible to the touch, conrms that the tool is fully
seated.
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3. Rotate the attachment in the direction indicated by arrow until the attachment alignment mark is directly in line with the locked symbol (Figure 5). You will
hear two clicks as the attachment is rotated.
4. Rotate the secondary lock to the locked position (Figure 6).
5. Gently pull on the tool to ensure that it is locked into the handpiece. Note: Tool should rotate freely. If not, unlock the assembly, re-seat the tool and re-lock the attachment.
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Straight attachment assembly Straight attachment assembly: Insert tool
Straight attachment assembly: Rotate attachment to lock Straight attachment assembly: Secondary lock
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Straight attachment disassembly
1. Hold the motor in palm of hand. Rotate the secondary lock to the unlocked position.
2. Rotate the attachment to the unlocked position.
3. Remove the dissecting tool from the attachment and discard the tool. For double lock attachments, push the sleeve on the attachment distally before rotating.
4. Use thumb and index nger to lift the attachment o of the motor.
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Angled attachment assembly
Notes:
• A dissecting tool may be installed and locked in the attachment before the angled attachment is installed onto the motor.
• Angled and straight attachments with the same length, marking and color band share the same dissecting tools.
• The Electric Stealth-Midas motor will not run properly unless the attachment is in the locked position.
• Always secure the secondary lock when using angled attachments to eliminate motion between the dissecting tool and the tracker on the motor, which could
impact navigation accuracy.
• Conrm that the dissecting tool packaging label has the Stealth-Midas logo ( ) if navigation is required.
• Smoke and/or excessive heat may be generated if attachment is not in the fully locked position. This may result in thermal injury to the surgeon or sta.
1. With the tool lock in the unlocked position, insert a dissecting tool into the angled attachment with a slight rotational motion (Figure 7). An audible click,
heard and perceptible by touch, conrms that the tool is fully seated.
2. Rotate the tool lock in the direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 8).
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3. Gently pull on the tool to ensure that it is locked into the handpiece.
4. Slide the angled attachment over the motor collet aligning triangular arrows on the attachment and the motor case. An audible click, heard and perceptible by
touch, conrms that the attachment is fully seated.
5. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. You will hear two
clicks as the attachment is rotated.
6. Verify that both the attachment to motor alignment mark and the tool lock alignment mark are directly in line with the locked symbol (Figure 9).
7. Rotate the secondary lock to the locked position (Figure 10). This secondary lock is required to eliminate motion between the dissecting tool and the tracker
on the motor, which could impact navigation accuracy. Toggle the attachment to conrm that the secondary lock is holding the tool securely.
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Angled attachment assembly: Insert tool Angled attachment assembly: Rotate tool lock
Angled attachment assembly: Tool/attachment lock to motor Secondary lock tightens attachment to motor
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Angled attachment alignment
Note: Angled attachments can connect in two dierent orientations.
1. To assemble the attachment so that the tracker faces to the left, insert the attachment facing up relative to the tracker. Rotate the attachment in the direction
indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. You will hear two clicks as the attachment is rotated. The tracker will now face to the left (Figure 11).
2. To assemble the attachment so that the tracker faces to the right, insert the attachment facing down relative to the tracker. Rotate the attachment in the
direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. You will hear two clicks as the attachment is rotated. The tracker will now face to the right (Figure 12).
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Angled attachment in left orientation Angled attachment in right orientation
Unlocked Locked Unlocked Locked
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3. Note that the direction of the locked angled attachment will match the label on the tracker (Figure 13). This information will be used when selecting the
appropriate navigation tool card.
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Angled left Angled right
Angled attachment direction matches tracker label
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Angled attachment disassembly
1. Rotate the Tool Lock to the unlocked position to remove the tool from the attachment.
2. Rotate the secondary lock to the unlocked position.
3. Rotate the attachment to the unlocked position and lift attachment o of the motor. For double lock attachments, push the sleeve on the attachment distally
before rotating.
ClearView tool assembly
Caution: Conrm that the dissecting tool packaging label has the Stealth-Midas logo ( ) if navigation is required.
1. Slide the ClearView tool over the motor collet aligning triangular arrows on the tool hub and the motor case. Note: The ClearView tools can connect in two dierent orientations, but will only navigate with the tool facing away from the tracker.
2. To assemble the ClearView tool, insert the tool facing to the left (Figure 14).
3. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. You will hear two
clicks as the attachment is rotated. The tracker will now face away from the tool (Figure 15).
4. Rotate the secondary lock to the locked position (Figure 16). This secondary lock is required to eliminate motion between the dissecting tool and the tracker
on the motor, which could impact navigation accuracy. Toggle the tool to conrm that the secondary lock is holding the tool securely.
5. Attach irrigation tubing (Figure 17).
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Unlocked position of ClearView tool Locked position of ClearView tool
Secondary lock attachment to motor ClearView tool with irrigation tubing attached
ClearView attachment disassembly
1. Remove irrigation tubing.
2. Rotate the secondary lock to the unlocked position.
3. Rotate the attachment to the unlocked position on the motor case.
4. Remove the attachment from the motor.
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Navigable dissecting tools and attachments
Dissecting Tools
Use only dissecting tools specically designed for use with this drill system. Conrm that the dissecting tool packaging label has the Stealth-Midas logo ( ) if navigation is required (Figure 18).
Midas tool label with Stealth-Midas logo
Attachments
The Stealth-Midas is compatible with all Midas attachment types that correspond to a navigable tool: straight, angled, variable, or double-locking.
Note:
• Variable attachments do not change the tip location of the dissecting tool.
• Adjusting variable tube exposure will not be represented on navigation image.
Sterile sphere assembly
Place single-use sterile spheres on each of the tracker’s four stems. Push each sphere onto the stem until it “clicks” into place. Make sure the sphere is rmly seated on the stem before navigating.
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Navigation
The following instructions for the Stealth-Midas are in addition to the general navigation instructions found in the Synergy Spine & Trauma Pocket Guide and StealthStation System Manual. User should consult the Synergy Spine & Trauma Pocket Guide and StealthStation System Manual for more detailed instruction on the StealthStation System.
Synergy spine software workow
Complete the following steps before navigating with the Stealth-Midas:
Synergy spine software workow
Select Synergy Spine & Trauma. Select Surgeon.
Select Procedure: Select the procedure type by selecting the imaging
modality: Stealth-Midas uses Optical Tracking.
Verify Instruments: Check that desired Stealth-Midas tool card is selected and matches physical hardware.
Set up Equipment: Ensure that all lines to essential equipment are green. If lines are dashed orange, check connections/cables.
Acquire Scan: The system will remain on this screen until the O-arm system image acquisition step has been performed.
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Instrument management: Adding Stealth-Midas to a procedure
The Verify Instruments screen displays tool cards (Tool List) for the instruments congured for the procedure. The Tool List may be scrolled using the up or down arrows at the bottom of the list. Select the tool card that matches the attachment and dissecting tool that is connected to the Stealth-Midas motor.
Note: Only one Stealth-Midas dissecting tool and attachment combination can be added to a procedure. Adding a new dissecting tool/attachment combination will automatically remove any other Stealth-Midas tool that had been selected.
Caution: If a tool or attachment orientation is changed during a procedure, you must return to the Add or Remove Instruments screen to change the tool in the software.
To add or remove instruments to the procedure, click [Add or Remove Instruments] (Figure 19) to display the Add or Remove Instruments dialog (Figure 20).
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Verify Instrument Screen: Select Add or Remove instruments if a dierent Stealth-Midas tool is desired
The Instruments Used in Procedure list displays prominently on the left. The Instruments Not Used in Procedure list displays on the right. Each list can be scrolled using the up or down arrows located at the bottom of each list. Use the search box located at the top of the Instruments Not Used in Procedure list to search for instruments without scrolling. Click [Search] and enter text for the instrument desired using the virtual keyboard onscreen or the system keyboard. The list is updated as text is entered or removed from the search box. Click [Done] to return to the Verify Instruments task. To add instruments to the Instruments Not Used in Procedure list, click [Add/Remove at this Site] to open the Admin panel to the Instruments tab (Figure 20).
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Add or Remove Instrument Dialog: If desired instrument is not listed, it can be added by selecting Add/Remove at Site
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Add or remove instruments used at the site from the Instruments tab. Then click [Done] to return to the Add or Remove Instruments dialog (Figure 21).
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Add or Remove Instrument from this site: Press done to return to Verify Instruments screen
Verifying the Stealth-Midas
The Verify Instruments screen (Figure 19) displays the tool card for the instruments selected for the procedure. Each tool card indicates whether those instruments are within the camera’s tracking view (main part of card is green) and whether it is veried (bottom part of the card).
Warnings:
• Physically inspect instruments for any defects. Never attempt to use a damaged instrument.
• Always verify an instrument before use.
• Always re-verify an instrument if you have changed tool or changed attachment orientations.
• Do not apply force when verifying dissecting tool.
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Conrm that the tool card selected matches the physical set-up of the Stealth-Midas (Figure 22).
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You can verify instruments either now or later at the Navigate task. To verify an instrument:
1. Conrm that the correct reference frame and Stealth-Midas tool cards are pictured in the Verify Instruments screen.
2. Click [Camera] and conrm that both the Stealth-Midas and the reference frame are visible in the Tracking View.
3. Insert the tip of the Stealth-Midas tool into the bottom of the divot in the reference frame (Figure 23). Keep the instrument as perpendicular to the divot as
possible.
4. Hold the Stealth-Midas steady for 2 seconds.
5. When the Stealth-Midas is veried, the system makes a positive sound (chime), the bottom of the instrument’s tool card turns green, and changes to Veried
status. When an instrument verication fails, the system makes a negative sound (bonk).
6. Click the right arrow to advance to the next task.
Conrm that the tool card selected matches the Stealth-Midas hardware
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Verify Instrument Screen: Stealth-Midas is being inserted into reference frame divot
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Starting navigation
Warning: Frequently conrm navigation accuracy and system responsiveness during live navigation. Use the Stealth-Midas while not rotating to touch several
bony anatomy landmarks and conrm that the locations identied on the images match the locations touched on the patient. If accuracy degrades, re-register the patient. For O-arm and 3D procedures, re-acquire the exam and re-register the patient.
Caution: Ensure the Reference Frame is properly secured to anatomy. Neglecting to verify that the Reference Frame is secured could result in navigational inaccuracy if the hardware moves in relation to the anatomy after registration is complete.
The Stealth-Midas with tool and attachment selected for the procedure is veried and automatically tracked when placed in the camera’s eld of view. If you have not already veried the Stealth-Midas, do so now by holding its tip in the reference frame divot. During navigation, the software updates the 2D and 3D views in real time to reect changes in the position of the Stealth-Midas’ tip on the anatomy. When navigation is active, the crosshairs display green. When navigation is frozen, the crosshairs display red. Tracked instrument status indicators display in green at the bottom right corner of the image area. The names of instruments that are not tracked are displayed in red.
To display the image modication buttons, click the Modify Images tab. Click the tab again to hide the buttons. Refer to the Synergy Spine & Trauma Pocket Guide for more details.
In the Standard Prole, the default layout for the navigation screen is 4-on-1 with the coronal, axial, sagittal, and 3D model images displayed (Figure 24). To change the layout, click the Control Panel tab, click [View Settings] and then select a layout. You can customize up to three view settings per procedure for quick cycling.
Use the Trajectory and Probe’s Eye views to visualize progression along the instrument axis (Figure 25).
• Trajectory View 1 is paraxial. The view is dened by a plane rotated 90 from the plane that denes Trajectory View 1.
• Trajectory View 2 is parasagittal or para-coronal. The view is dened by the plane containing the probe and running parallel to the long axis of the patient’s
body.
• The Probe’s Eye View shows the plane that is located at the probe tip, perpendicular to the probe. This perspective mimics what the surgeon would see if looking down the shaft of the Stealth-Midas.
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Default 4-on-1 layout Trajectory 1, Trajectory 2, and Probe’s Eye Views
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Projecting
Click [Select Projection] to add a projection onto the tip of the Stealth-Midas’ virtual display. The tip projection will extend outward along the instrument’s linear trajectory and is adjustable in length and width using on-screen controls (Figure 26).
Selecting tip
Click [Select Tip] to choose to display the CAD model for the selected Stealth-Midas dissecting tool and attachment (Figure 27).
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Stealth-Midas with a cylinder projection added Stealth-Midas displayed as a CAD model
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Changing views
Click [Cycle Views] to cycle through the image presets selected in View Settings (Figure 28).
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Click cycle views to display alternate views
Planning
Click [Select Plan] to choose which plan to display on the images. The plans are color coded, and multiple plans can be displayed (Figure 29).
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Stealth-Midas with plan selected
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Troubleshooting
Issue Possible Cause Action
Motor is too hot to touch/hold Inadequate cool down period following
sterilization
Attachment transferring heat to the motor. Switch attachments to determine whether the heat is being
Heavy side loading during dissection. Discontinue use and rest the motor by using it intermittently or
Inadequate irrigation Ensure adequate irrigation to surgical site during bone dissection.
Tool is dicult to remove from attachment Aging of attachment
Use of reprocessed tools
Use of an unauthorized refurbisher
Improper cleaning Clean the attachment thoroughly according to the instructions in
Attachment will not seat properly on the motor
Motor does not run Cables not properly connected Ensure motor and foot control cables are properly connected.
Motor with attachment rotates, but an abnormal noise is heard.
Motor collet ats are not aligned Use the Stealth-Midas motor wrench to rotate the at closest to
Speed setting is too low Ensure that a speed greater than 3000 rpm is selected.
Attachment not properly installed and locked onto the motor
Internal failure of motor and/or console. Change motor or console to isolate the problem.
Foot control not properly functioning Check for obstruction under the foot pedal.
Cables damaged Check cable for cracks, splits, or bent connector pins.
Bearings are worn Change the attachment to isolate the location of the problem.
Poor electrical connection Check all connections from the electrical source to console.
Internal failure of motor, console, or cable Change motor or console to isolate the failing component.
Attachment not properly installed Remove and reinstall the attachment and dissecting tool.
Motor must be allowed to cool down following steam sterilization.
generated by the motor or the attachment.
wrap the motor with a moist sterile towel.
Contact Customer Service.
this manual.
Change tool.
the motor case until its marker is aligned with the marker on the at farthest away from the motor case.
Remove and reinstall the attachment and dissecting tool to ensure proper installation.
Ensure motor and foot control cables are properly connected.
Clearview tool or irrigation does not run properly.
System does not navigate Spheres not properly seated on posts Reseat spheres
Camera does not see spheres Reposition navigation camera. Ensure spheres on Stealth-Midas
Instrument not veried Verify instrument by placing the Stealth-Midas tip in the
Non-navigated dissecting tool selected Ensure tool has Stealth-Midas logo on packaging.
Incorrect attachment or tool selected in software
Incorrect angled attachment orientation selected
Angled attachment not in fully locked position Conrm that attachment to motor lock and secondary lock are
Incorrect ClearView orientation. Conrm ClearView tool faces away from tracker.
Refer to Midas Rex Clearview User’s Guide.
face the camera and that the sphere surface is clean.
reference frame divot.
Conrm that the dissecting tool in the Stealth-Midas matches what was selected in the software
Conrm that angled attachment orientation matches what was selected in the software.
both secure.
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Cleaning and sterilization
Electric Stealth-Midas Cleaning and Sterilization instructions are subject to change. Up to date instructions are available online at manuals.medtronic.com.
Warnings and Precautions • Do not remove tracker from motor.
• Remove Navigation spheres prior to cleaning and sterilization.
• Do not soak/submerge devices.
• Do not use ultrasonic cleaners to clean devices.
• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach,
sodium hydroxide, formic acid, or solutions containing glutaraldehyde.
• The use of a washer-disinfector for cleaning may cause a degradation in performance.
• Allow an adequate cooling period after steam sterilization.
Limitations Verify functionality prior to re-use.
Point of Use Follow hospital procedures.
Containment and Transportation
Preparation for Decontamination
Cleaning: Automated (Do NOT use ultrasonic washer)
Cleaning: Manual • Wipe all external surfaces of the motor and cable with a cloth dampened with a neutral enzymatic detergent, pH 6.0-
Drying and Lubrication 1. Thoroughly dry motor. An air gun may be used to blow moisture out.
Disinfection Follow hospital procedures.
Packaging For sterilization, place devices in instrument tray. Instrument tray should be wrapped with up to two layers of 1-ply
Sterilization (Temperatures are minimum required, times are minimum required)
It is recommended that devices are reprocessed as soon as is practical following use.
Follow hospital procedures.
• Review the washer-disinfector warning above, before using this cleaning method.
• Remove devices from instrument trays before placing into washer baskets.
• Orient devices following recommendations of the washer/disinfector manufacturers.
Recommended Washer Cycle
8.0.
• Brush motor case and collet with a nylon brush dampened with a neutral enzymatic detergent.
• Rinse motor thoroughly under running water, collet end pointed down. Dry collet and motor with towel.
• Verify that devices are visually clean after manual cleaning.
Note: Medtronic no longer recommends using the cleaning nozzle (PA120), as this may cause some devices to overheat.
2. Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate motor:
• Holding the can approximately 10-15 cm (3-6 inches) away from the motor, spray all components that move, rotate, or slide with three quick squirts.
• Remove excess lubricant with a clean cloth.
polypropylene wrap. For use in the US, a FDA-cleared wrap should be used.
Steam Sterilization
Cycle Pre -Vac Pre-Vac Pre-Vac
Temperature 132 °C 134 °C 134 °C
Time 4 minutes 18 minutes 3 minutes
Drying 20 minutes 20 minutes 15 minutes
STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen
LIQUID CHEMICAL STERILIZATION
100% EtO Sterilization Parameters
Preconditioning 55-59 °C, 70 ±5 % relative humidity, 30 minutes
Sterilization Temperature 55-59 °C
Phase Recirculation Time Water
Temperature
Pre-Wash 2 minutes Cold tap water Not applicable
Wash 5 minutes 66°C (set point) Neutral enzymatic detergent, pH 6.0-8.0
Final Rinse 1 minute Hot tap water Not applicable
internal diameter and length restrictions.
Do not use liquid chemical sterilants due to immersion procedure.
Relative Humidity 70 +/- 5 %
Ethylene oxide concentration 725 +/- 25 mg/L
Gas exposure time (full-cycle) 4 hours
Aeration 55-59 °C, 18 hours
Detergent Type and Concentration
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Maintenance, Inspection and Testing
• Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
• Verify functionality prior to re-use.
Storage Store with other sterile devices.
Additional Information None
Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor
to ensure that the reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process. Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with prions or a Transmissible Spongiform Encephalopathy (TSE) such as Creutzfeldt-Jakob disease (CJD).
Legend Attachments Cleaning and Sterilization instructions are subject to change. Up to date instructions are available online at manuals.medtronic.com.
Warnings and Precautions • Do not soak/submerge devices.
• Do not use ultrasonic cleaners to clean devices.
• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach,
sodium hydroxide, formic acid, or solutions containing glutaraldehyde.
• The use of a washer-disinfector for cleaning may cause a premature degradation in performance.
• Allow an adequate cooling period after steam sterilization.
• Use ONLY nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being
secured properly in the handpiece.
Limitations Verify functionality prior to re-use.
Point of Use Follow hospital procedures.
Containment and
It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Preparation for
Follow hospital procedures.
Decontamination
Cleaning: Automated (Do NOT use ultrasonic washer)
• Review the washer-disinfector warning above, before using this cleaning method.
• Manually rinse attachments under tap water, until no visible soil is noticed, before placing them into the automatic
washer.
• Remove devices from instrument trays before placing into washer baskets.
• Orient devices following recommendations of the washer/disinfector manufacturers.
Recommended Washer Cycle
Phase Recirculation Time Water
Temperature
Detergent Type and Concentration
Pre-Wash 2 minutes Cold tap water Not applicable
Wash 5 minutes 66 °C (set point) Neutral enzymatic detergent, pH 6.0-8.0
Rinse 1 minute Hot tap water Not applicable
Cleaning: Manual 1. Wipe all attachments with a cloth, dampened with a surgical instrument cleaning solution.
2. Attachments may be mechanically agitated in cleaning solution, but not soaked or immersed.
3. A nylon brush dampened with a surgical instrument cleaning solution may be used to clean the external surfaces and internal connecting surfaces of the attachments.
4. Straight attachments have special cleaning brushes sized to the attachment’s internal diameter. Push the brush wet with surgical instrument cleaning solution through the attachment from rear to front to loosen and remove debris trapped inside.
5. Move any moveable parts back and forth to allow solution to thoroughly clean attachment.
6. Rinse thoroughly with tap water.
Drying and Lubrication 1. Thoroughly dry attachments. An air gun may be used to blow moisture out from rear to front of attachment.
Note: Medtronic no longer recommends using the Stealth-Midas attachment cleaning nozzle (PA120), as this may cause
some attachments to overheat.
2. Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate attachments:
• Holding the can approximately 10-15 cm (3-6 inches) away from the attachment, spray all components that move, rotate, or slide with three quick squirts.
• Articulate movable components to ensure proper lubrication.
• Remove excess lubricant with a clean cloth.
Disinfection Follow hospital procedures.
Packaging For sterilization, place devices in instrument tray. Instrument tray should be wrapped with up to two layers of 1-ply
polypropylene wrap. For use in the US, a FDA-cleared wrap should be used.
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Sterilization (Temperatures are minimum required, times are minimum required)
Maintenance, Inspection and Testing
Storage Store with other sterile devices.
Additional Information None
Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor
to ensure that the reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires valida­tion and routine monitoring of the process.
Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.
Steam Sterilization
Cycle Pre -Vac Pre-Vac Pre-Vac
Temperature 132 °C 134 °C 134 °C
Time 4 minutes 18 minutes 3 minutes
Drying 15 minutes 20 minutes 10 minutes
Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with prions or a Transmissible Spongiform Encephalopathy (TSE) such as Creutzfeldt-Jakob disease (CJD).
STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen
internal diameter and length restrictions.
LIQUID CHEMICAL STERILIZATION
100% EtO Sterilization Parameters
Preconditioning 55-59 °C, 70 ±5% relative humidity, 30 min
Sterilization Temperature 55-59 °C
• Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
• Verify functionality prior to re-use.
Do not use liquid chemical sterilants due to immersion procedure.
Relative Humidity 70 ±5 %
Ethylene oxide concentration 725 +/- 25 mg/L
Gas exposure time (full-cycle) 4 hours
Aeration 55-59 °C, 18 hours
Preventative maintenance
For the Electric Stealth-Midas System, the EHS System Preventive Maintenance Manual will assist you in getting the greatest ownership value from your Stealth­Midas EHS System, while helping to maximize its performance, safety and reliability. The scheduled preventive maintenance/service program is in addition to the required routine cleaning after each use. Please refer to the preventive maintenance manual for the specic steps necessary to maintain the Electric Stealth-Midas System.
Limited warranty
A. This Limited Warranty provides the following assurance for the customer who purchases a Medtronic Stealth-Midas System. This Limited Warranty is extended
only to the buyer purchasing the Electric Stealth-Midas directly from Medtronic or from its aliate or its authorized distributor or representative. The Electric Stealth-Midas includes the motor with integrated tracker and motor cable.
i. Should a System Component fail to function to Medtronic’s published specications during the term of this Limited Warranty [one (1) year from the
date of sale of a new System Component or ninety (90) days from the date of sale of a refurbished or used System Component], Medtronic will either repair or replace the Motor Component or any portion thereof.
ii. Should a Single Use Component fail to function to Medtronic’s published specications prior to its “use by” date, Medtronic will replace the Single Use
Component.
B. To qualify for this Limited Warranty, the following conditions must be met:
i. The Product must be used on or before its “Use By” or “Use Before” date, if applicable. ii. The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling. iii. Medtronic must be notied in writing within thirty (30) days following discovery of defect. iv. The Product must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in (iii) above. v. Upon examination of the Product by Medtronic, Medtronic shall have determined that: (i) the Product was not repaired or altered by anyone other
than Medtronic or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services, if applicable, have been performed on the Product.
C. This Limited Warranty is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED WHETHER
STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall Medtronic be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the IPC System, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise
D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law.
Users may benet from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this Limited Warranty is held by any court of competent jurisdiction to be illegal, unenforceable, or in conict with applicable law, the validity of the remaining portion of the Limited Warranty shall not be aected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid.
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Symbols
EUR · USA · JPN · AUS
IPX1
IPX7
DEHP
NIM
EC REP
ACC
STERILE
On O Button Package Contents Follow Instructions
For Use
EMC Compliance Mark Do Not Oil Do Not Immerse Caution: Federal law
Fuse
Use By Date
Protected Against Vertical Water Drops
Protected Against The Eects Of Temporary Immersion In Water
F
Oscillate Authorized
Forward Precaution: Pinch Hazard.
Conforms to ANSI/AAMI ES 60601-1, IEC/EN 60601-1. Certied to CSA C22.2 No.601.1
(USA) restricts this device to sale by or on the order of a physician.
Representative in the European Community
Keep Fingers Clear Of Rollers
>120 VAC
Accessory Type BF Applied Part
AC Power Start/Stop Foot Pedal Connector Protective Earth
Output RF Transmitter
(Interference May Occur)
Is Approximately Equal To
Non-Sterile Stim Bur Connector Right Foot Control
Consult Instructions for Use
R
BUR
Quantity
Not Greater Than 120vac
EHS
NIM Console Connector Top Foot Control Unit
Electrical High Speed Handpiece Connector
Reverse
Fine Irrigant Adjustment
Left Foot Control Unit Button / Mode Button
Unit Button / Control Button
Button / Handpiece Button
Locked If the single use symbol
PHT
PHT Contains DEHP (di­2-ethyl hexyl phthalate)
Equipotential Ground Connector
Use With
RoHS - Environmental friendly use period ­China (SJ/T11364-2006)
Do Not Dispose Of This Product In The Unsorted Municipal Waste Stream. Dispose Of This Product According to Local Regulations. See Recycling. Medtronic. Com For Instructions On Proper Disposal Of This Product.
is on the device label then this device is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
19
Page 22
Symbols
REGULATOR
REF
LOT
STERILE R
SN
!USA
Dissecting Tool
Caution
Fr
Unlocked Handpiece Adapter Motor
World Wide Standard for Medical Tubing Diameter
Accessory
Accessory
Regulator
ON
<120s
XX° C >X° C
L
Applied Part Duty Cycle Date of Manufacture Attachment
OFF
>180s
Catalog Number Manufacturer
Lot Number Brush
Serial Number Ergonomically
engineered
USA Only
Skeeter
1
Pump Head 1
Pump Head 2 Instrument Case
Bone Mill
2
Angled attachment with tracker oriented to the left
<XX° C
Temperature Limitation Compliant with
XX° C
R
Angled attachment with tracker oriented to the right
European Council Directive MDD 93/42/ EEC.
REFURBISHED
Bone Mill Control Unit
Sterilized Using Irradiation
Multi-Use Disposable Attachment
Dissecting Tool
Lubricant/Diuser
Dissecting tool compatible with Stealth­Midas Navigation
Refurbished
20
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The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual. Refer to manuals.medtronic.com for the current version.
Page 24
Medtronic Powered
EC REP
Surgical Solutions
4620 North Beach Street Fort Worth, TX 76137 USA medtronic.com +1 800 643 2773
Authorized Representative in the European Community
Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands +31 45 566 8000 manuals.medtronic.com
Europe/Middle East/Africa
Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH- 1131 Tolochenaz Switzerland +41 21 802 7000
Australia
Medtronic Australasia Pty Ltd 5 Alma Road Macquarie Park, NSW 2113 Australia
Canada
Medtronic of Canada Ltd 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada +1 905 460 3800
Technical manuals
medtronic.com/manuals
© 2016 Medtronic, Inc. 175033EN REV B 2016-09
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