Pneumatic Stealth-Midas™ System
Model: PM700N
Système pneumatique Stealth-Midas™
Sistema Stealth-Midas™ neumático
Sistema pneumático Stealth-Midas™
Sistema pneumático Stealth-Midas™
Πνευματικό σύστημα Stealth-Midas™
Modèle: PM700N
Modelo: PM700N
Modelo: PM700N
Modelo: PM700N
Μοντέλο: PM700N
User’s Guide
FR Mode d’emploi ES Guía del usuario PT-BR Manual do usuário PT-PT Guia do utilizador EL Οδηγός χρήστη
The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Stealth-Midas™, StealthStation™, Midas Rex™,
MR7™, 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.
Contents
Glossary ...................................................................................................................................................................................... 2
Indications for use .................................................................................................................................................................. 2
Device description .................................................................................................................................................................. 2
Warnings .................................................................................................................................................................................... 2
No Latex Policy ........................................................................................................................................................................ 2
Pneumatic Stealth-Midas Motor........................................................................................................................................ 3
Setting up the operating room .......................................................................................................................................... 3
Pneumatic Stealth-Midas system ...................................................................................................................................... 5
Dissecting tools and attachments .................................................................................................................................... 7
Navigation ............................................................................................................................................................................... 10
Troubleshooting ....................................................................................................................................................................18
Cleaning and sterilization .................................................................................................................................................. 20
Preventative Maintenance .................................................................................................................................................22
Limited warranty ................................................................................................................................................................... 23
Symbols .................................................................................................................................................................................... 24
Components........................................................................................................................................................................ 3
Power source requirements ........................................................................................................................................... 3
Pneumatic connections .................................................................................................................................................. 4
Setting up the system ...................................................................................................................................................... 5
Connecting the motor ..................................................................................................................................................... 6
Activating the motor ........................................................................................................................................................ 6
Disassembling the system.............................................................................................................................................. 7
Depressurize the System ....................................................................................................................................... 7
Disconnect hoses ..................................................................................................................................................... 7
Discard the lubricant/diuser Cartridge .......................................................................................................... 7
Remove the attachment and tools .................................................................................................................... 7
Straight attachment assembly ..................................................................................................................................... 7
Straight attachment disassembly ................................................................................................................................ 8
Angled attachment assembly ....................................................................................................................................... 8
Angled attachment alignment ..................................................................................................................................... 9
Angled attachment disassembly ................................................................................................................................. 9
Navigable dissecting tools and attachments ....................................................................................................... 10
Sterile sphere assembly ................................................................................................................................................10
Synergy spine software workow .............................................................................................................................10
Instrument management: Adding Stealth-Midas to a procedure .................................................................11
Verifying the Stealth-Midas .........................................................................................................................................13
Starting navigation ......................................................................................................................................................... 14
Projecting ........................................................................................................................................................................... 16
Selecting tip ......................................................................................................................................................................16
Changing views ................................................................................................................................................................17
Planning .............................................................................................................................................................................. 17
Glossary
Dissecting tool Disposable cutting tool that connects to 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 identied 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 qualied 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 operate the Stealth-Midas system in the presence of Magnetic Resonance Imaging devices.
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 conrmed.
W7 During navigation, and after decompression and/or distraction, frequently conrm 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 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 specically 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. Conrm that the dissecting tool package label indicates Stealth-Midas (Stealth-Midas) if navigation is
required.
W17 Do not use the Stealth-Midas system before proper cleaning and sterilization.
W18 The tracker is permanently axed 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 MR7 Instructions for Use 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 identied 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.
2
Pneumatic Stealth-Midas Motor
Components
The Pneumatic Stealth-Midas motor is a high-speed, high-torque motor used to dissect bone and biomaterials.
Pneumatic Stealth-Midas
1. Hose
2. Tracker
3. Pneumatic motor
4. Collet
5. Foot switch connection
Setting up the operating room
Power source requirements
Required Operating (Dynamic)
Pressure
80–120 psi 100 psi 12 cubic feet/minute Nitrogen or Dry-Filtered Compressed
5.5–8.3 bar 6.9 bar 340 liters/minute
CAUTION: Do not run the motor at an operating pressure above or below the required operating pressure range. Operating pressure below 80 psi (5.5 bar) may
not provide proper lubrication to the motor. Operating pressure above 120 psi (8.3 bar) may damage or reduce the life of the motor.
Nominal Operating (Dynamic)
Pressure
Approximate Flow Rate Required Gas Type
Air
3
Pneumatic connections
1
Gas connection options
1. Regulator Hose (N2 DISS)
2. N2 DISS to Air DISS Adapter Gas Source
3. N2 DISS to Male Schrader Adapter Gas Source
4. Gas Source (N2 DISS)
CAUTION: If you are using the Midas Rex Safety Valve Regulator instead of the Legend Regulator, you must replace the in-line oiler with the DISS/WF4 adapter
before use.
4
5. Regulator
6. DISS/WF4 Adapter
7. Regulator
Pneumatic Stealth-Midas system
Setting up the system
Installing the Oiler Cartridge
1. Set the non-running (static) pressure to 80 -- 120 psi (5.5 – 8.3 bar) at the gas source. Operating (dynamic) pressure may be adjusted later.
2. Hold the lubricant/diuser cartridge perpendicular to the housing (Figure 2), and press the cartridge’s circular tting onto the housing’s circular receptacle
(Figure 3), breaking the foil seal.
3. Rotate the cartridge down until it clicks into place.
4. Verify that the lock symbol on the cartridge is lined up with the notch on the housing (Figure 4).
Warnings:
• Failure to properly secure the lubricant/diuser cartridge may cause injury to operator and/or operating room sta.
• Do not attempt to remove the lubricant/diuser cartridge while the system is pressurized.
Cautions:
• Do not use the Pneumatic Stealth-Midas motor without a lubricant/diuser installed.
• Do not use a lubricant/diuser cartridge for more than one hour of drill time.
• Do not re-use a lubricant/diuser cartridge. It is a single-use product.
• Do not attempt to rell a used lubricant/diuser cartridge.
• Do not use a lubricant/ diuser cartridge if it appears to be damaged, or if the inner foil seal is punctured.
2
Aligning the lubricant/diuser
cartridge with the housing
3
Pressing the cartridge onto the housing Correctly installed lubricant/ diuser cartridge
4
5
Connecting the motor
1
2
3
Connect the motor hose to the motor port on top of the pneumatic control unit, by swinging the port cover to the side and pressing the end of the hose into the
port (Figure 5).
Warning: Do not pinch, kink, obstruct, cut, tear, or step on the motor/exhaust hose. This may cause the hose to burst, potentially injuring the patient or user.
Note: The motor’s exhaust hose may have an oily lm on the external surface from the pressure and/or temperature dierentials following sterilization. Wipe the
exhaust hose with a sterile cloth prior to use. If motor continues to have oil on the exhaust hose, return the motor to Medtronic for refurbishing.
Prior to installation of a Legend attachment and dissecting tool, ensure that the arrows on the motor collet ats are aligned (Figure 6). If the arrows are not aligned,
use the motor wrench to turn the collet at closest to the motor case until its arrow is aligned with the arrow on the other collet at.
Activating the motor
1. Activate the motor by pressing on the foot control pedal (Figure 7).
2. Adjust operating pressure as needed at the compressed gas source until supply pressure gauge on pneumatic control unit reads within a range of 80 -- 120
psi (5.5 – 8.3 bar) as required. Operating pressure (with motor running) will decrease slightly from the non-running (static) pressure setting when the motor is
activated.
Note: To decrease pressure, turn down the in-house compressed gas source or loosen the pressure handle on the regulator. Push down on the pressure relief at
the pneumatic control unit to exhaust pressure in the hoses. Then readjust pressure as needed.
5
Connecting the motor hose to the motor port Aligning the collet ats
6
7
Foot control pedal
1. Foot control pedal
2. Air pressure gauge
3. Control slide
6
8
1. Motor port connection button
2. Pressure relief button
Motor port connection and pressure relief buttons
1
Disassembling the system
Depressurize the System
1. Turn o the compressed gas at the source.
2. Press the pressure relief button on the pneumatic control unit, to
release remaining gas (Figure 8).
Warning: Do not disassemble equipment before the gas is released from
the control unit.
Disconnect hoses
Release the motor hose from the control unit, by holding the hose rmly
and pressing the motor port connection button (Figure 8).
2
Discard the lubricant/diuser Cartridge
Remove the lubricant/diuser cartridge from the housing and discard it.
Caution: Do not re-use a lubricant diuser cartridge. It is a single-use
product.
Remove the attachment and tools
1. Follow the applicable instructions in the Dissecting Tools and
Attachments section of this manual to remove the attachment and
tool from the motor.
2. Discard used dissecting tools in an appropriate container.
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. Conrm that the dissecting
tool packaging label has the Stealth-Midas logo ( )on it 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 Pneumatic Stealth-Midas motor will not run properly unless the attachment is in the locked position.
• 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 9). An audible click, heard and
perceptible by touch, conrms that the tool is fully seated.
2. Insert the tool into the attachment with a slight rotational motion (Figure 10). An audible click, heard and perceptible to the touch, conrms that the tool is
fully seated.
3. Rotate the attachment in the direction indicated by arrow until the attachment alignment mark is directly in line with the locked symbol (Figure 11). You will
hear two clicks as the attachment is rotated.
4. Rotate the secondary lock to the locked position (Figure 12).
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.
9
11 12
Sliding the attachment over the motor collet Inserting the dissecting tool into the attachment
Attachment in the locked position Locking the secondary lock
10
7
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.
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 Pneumatic 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.
• Conrm that the dissecting tool packaging label has the Stealth-Midas logo on it ( ) 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 13). An audible click,
heard and perceptible by touch, conrms 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 14).
13
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, conrms that the tool 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 15).
7. 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 attachment to conrm that the secondary lock is holding the tool securely.
Motor alignment mark and tool lock alignment mark aligned with lock
15
Inserting the dissecting tool into the attachment Tool lock in the locked position
symbol
14
16
Secondary lock tightens attachment to motor
8
Angled attachment alignment
1. Note that angled attachments can connect in two dierent orientations. 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 17).
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 18).
17
3. Note that the direction of the locked angled attachment will match the label on the tracker (Figure 19). This information will be used when selecting the
appropriate navigation tool card.
Angled attachment in left orientation Angled attachment in right orientation
Unlocked Locked Unlocked Locked
18
19
Angled left Angled right
Angled attachment direction matches tracker label
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.
9
Navigable dissecting tools and attachments
Dissecting Tools
Use only dissecting tools specically designed for use with this drill system. Conrm that the dissecting tool packaging has the Stealth-Midas logo
( ) on it if navigation is required (Figure 20).
20
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.
Note: 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.
Navigation
The following instructions for the Pneumatic 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 workow
Complete the following steps before navigating with the Stealth-Midas:
Select Synergy Spine & Trauma. Select Surgeon.
10
Select Procedure: Select the procedure type by selecting the imaging
modality: Stealth-Midas uses Optical Tracking.
Set up Equipment: Ensure that all lines to essential equipment are
green. If lines are dashed orange, check connections/cables.
Verify Instruments: Check that desired Stealth-Midas tool card is
selected and matches physical hardware.
Acquire Scan: The system will remain on this screen until the
O-arm system image acquisition step has been performed.
Instrument management: Adding Stealth-Midas to a procedure
The Verify Instruments screen displays tool cards (Tool List) for the instruments congured 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.
11
To add or remove instruments to the procedure, click [Add or Remove Instruments] to display the Add or Remove Instruments dialog (Figure 21).
21
Verify Instruments Screen: Select Add or Remove instruments if a dierent 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 22).
Add or Remove Instrument Dialog: If desired instrument is not listed, it can be added by selecting Add/Remove at this Site
22
12
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 23).
23
Add or Remove Instrument from this site: Press done to return to Verify Instruments screen
Verifying the Stealth-Midas
The Verify Instruments screen (Figure 21) 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 veried (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.
Conrm that the tool card selected matches the physical set-up of the Stealth-Midas (Figure 24).
24
Conrm that the tool card selected matches the Stealth-Midas hardware
13
You can verify instruments either now or later at the Navigate task. To verify an instrument:
1. Conrm that the correct reference frame and Stealth-Midas tool cards are pictured in the Verify Instruments screen.
2. Click [Camera] and conrm 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 25). 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 veried, the system makes a positive sound (chime), the bottom of the instrument’s tool card turns green, and changes to Veried
status. When an instrument verication fails, the system makes a negative sound (bonk).
6. Click the right arrow to advance to the next task.
25
Verify Instrument Screen while Stealth-Midas is being inserted into reference frame divot
Starting navigation
Warning: Frequently conrm navigation accuracy and system responsiveness during live navigation. Use the Stealth-Midas while not rotating to touch several
bony anatomy landmarks and conrm that the locations identied 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 veried and automatically tracked when placed in the camera’s eld of view. If you have
not already veried 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 reect 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 modication 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.
14
In the Standard Prole, the default layout for the navigation screen is 4-on-1 with the coronal, axial, sagittal, and 3D model images displayed (Figure 26). 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.
26
Default 4-on-1 layout
Use the Trajectory and Probe’s Eye views to visualize progression along the instrument axis (Figure 27).
• Trajectory View 1 is paraxial. The view is dened by a plane rotated 90o from the plane that denes Trajectory View 1.
• Trajectory View 2 is parasagittal or para-coronal. The view is dened 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.
27
Trajectory 1, Trajectory 2, and Probe’s Eye Views
15
Projecting
Click [Select Projection] to add a projection onto the tip of the Stealth-Midas’ virtual display (Figure 28). The tip projection will extend outward along the
instrument’s linear trajectory and is adjustable in length and width using on-screen controls.
28
Stealth-Midas with a cylinder projection added
Selecting tip
Click [Select Tip] to choose to display the CAD model for the selected Stealth-Midas dissecting tool and attachment (Figure 29).
29
Stealth-Midas displayed as a CAD model
16
Changing views
Click [Cycle Views] to cycle through the image presets selected in View Settings (Figure 30).
30
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 31).
31
Stealth-Midas with plan selected
17
Troubleshooting
Issue Possible Cause Action
Motor not Running or Low on Power Hoses not properly connected. Make sure all connections are secure.
Check gas supply pressure gauge.
Operating pressure inadequate. Increase pressure according to compressed gas requirements, if
necessary.
Attachment not properly installed and locked
onto the motor.
Foot pedal on pneumatic control unit not
functioning properly.
Motor stalls Manually spin the dissecting tool, then activate the motor. If the
Motor Continues to Run Pneumatic control unit is not functioning
properly.
System Makes an Abnormal Noise Inadequate lubrication Check for proper installation of the lubricant/diuser cartridge.
Motor’s exhaust hose is damaged, or internal
pressure hose is detached.
Worn bearings Switch attachments to determine whether the bearings are
Attachment not properly installed and locked
onto the motor.
Safety relief valve has been activated by high
air pressure.
Motor is Too Hot to Touch/Hold Inadequate cool down period following
sterilization
Inadequate lubrication Check for proper installation of the lubricant/diuser cartridge.
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.
Attachment will not properly seat in the
motor
Tool is Dicult to Remove from
Attachment
Dissecting tool fails A non-Legend dissecting tool is being used. Replace with a Legend dissecting tool.
Dissecting tool vibrates excessively Dissecting tool’s size and geometry may create
Motor collet ats are not aligned Use the Legend motor wrench to rotate the at closest to the
Aging of attachment
Improper cleaning
Use of reprocessed tools
Use of an unauthorized refurbisher
Worn attachment bearings Try another attachment to isolate the location of the problem. If
Attachment and tool are not compatible. Match color code on the dissecting tool packaging to the color
Motor is damaged. Return motor to Medtronic to be refurbished.
Dissecting tool’s size and geometry may
contribute to ailing at certain speeds.
excessive vibration at certain speeds.
Remove and re-install attachment and tool to ensure proper
installation and locking of attachment onto motor.
Check for obstructions under the foot pedal. If foot pedal
continues to fail, return the pneumatic control unit to Medtronic
to be refurbished.
motor continues to stall, return it to Medtronic to be refurbished.
Depressurize the system and return the pneumatic control unit to
Medtronic to be refurbished.
If the problem persists, replace the cartridge. If replacing the
cartridge does not x the problem, return the motor to Medtronic
for refurbishing.
Depressurize the system and return the motor to Medtronic to be
refurbished.
failing in the motor or in the attachment. Return the failing
component to Medtronic to be refurbished.
Remove and reinstall attachment and tool to ensure proper
installation and locking of the attachment onto the motor.
Ensure that air operating/dynamic air pressure is no higher than
120 psi.
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.
motor case until its marker is aligned with the marker on the at
farthest away from the motor case.
Return to Medtronic to be refurbished or purchase new
equipment.
the attachment is failing, return it to Medtronic.
code of the attachment.
Adjust the speed by changing the pressure setting or foot
control. If ailing persists, change dissecting tool.
Adjust the speed by changing the pressure setting or foot
control. Change dissecting tools.
18
Issue Possible Cause Action
Dissecting tool will not seat properly in
the motor or attachment collet
Smoke is generated by the attachment or
motor
System does not navigate Spheres not properly seated on posts Reseat spheres.
Debris in collet of attachment or motor Clean the attachment or motor thoroughly according to the
instructions in this manual. If cleaning does not correct the
problem, return the attachment or motor to Medtronic to be
refurbished.
A non-Legend dissecting tool is being used. Replace with a Legend dissecting tool.
Attachment is not in the locked position. Make sure the attachment is in the locked position.
Camera does not see spheres Reposition navigation camera. Ensure spheres face the camera.
Clean sphere surface, if necessary.
Instrument not veried Verify instrument by placing the Stealth-Midas tip in the
reference frame divot.
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 Conrm that attachment to motor lock and secondary lock are
Conrm that the dissecting tool in the Stealth-Midas matches
what was selected in the software.
Conrm that angled attachment orientation matches what was
selected in the software.
both secure.
19
Cleaning and sterilization
Pneumatic Stealth-Midas Motor
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 Pneumatic Stealth-Midas devices.
• Do not use ultrasonic cleaners to clean Pneumatic Stealth-Midas 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.
Instructions
Point of Use No particular requirements. Follow hospital procedures.
Containment and
Transportation
Preparation for
Decontamination
Cleaning:
Automated
(Do NOT use ultrasonic washer)
Cleaning: Manual 1. Wipe all external surfaces of the motor and hose, and wipe the inner surface of oiler housing with a cloth dampened
Drying and Lubrication 1. Thoroughly dry motor. An air gun may be used to blow moisture out.
Disinfection No particular requirements. Follow hospital procedures.
Packaging For sterilization, place devices in instrument tray. Instrument tray should be wrapped with up to two layers of 1-ply
It is recommended that devices are reprocessed as soon as is practical following use.
No particular requirements. 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.
Verify that devices are visually clean after automated cleaning.
Recommended Washer Cycle
Pre-Wash: Cold tap water, 2 minutes
Wash: 66°C, 5 minutes using a neutral enzymatic detergent, pH 6.0–8.0
Rinse: Hot tap water, 1 minute
with a neutral enzymatic detergent, pH 6.0–8.0.
2. Brush motor case and collet with a nylon brush dampened with a neutral enzymatic detergent. If using the Pneumatic
Stealth-Midas Touch motor, be sure to brush under the nger control lever.
3. Rinse motor thoroughly under running water, collet end pointed down. Dry collet and motor with lint-free towel.
4. Verify that devices are visually clean after manual cleaning.
Note: Medtronic no longer recommends using the clean 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.
20
Sterilization
(Temperatures are minimum
required, times are minimum
required)
Maintenance, Inspection and
Testing
Storage Store with other sterile devices.
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 as actually performed, using equipment, materials, and personnel in the reprocessing facility,
achieves the desired result. This normally requires validation and routine monitoring of the process.
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
*Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with prions
or a Transmissible Spongiform Encephalopathy (TSE) such as Creutzfeldt-Jakob disease (CJD).
STERRAD Sterilization: Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal
diameter and length restrictions.
100% EtO Sterilization Parameters:
Preconditioning: 55–59°C, 70 ±5% relative humidity, 30 minutes
Temperature: 55–59°C
Relative humidity: 70 ±5%
Ethylene oxide concentration: 725 ± 25mg/L
Gas exposure time (full-cycle): 4 hours
Aeration: 18 hours at 55–59°C
Liquid Chemical Sterilization: Do not use liquid chemical sterilants due to immersion procedure.
Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
After cleaning and sterilization, verify functionality prior to re-use.
Legend Attachments / Tubes
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 Legend devices.
• Do not use ultrasonic cleaners to clean Legend 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.
Instructions
Point of Use No particular requirements.
Containment and
Transportation
Preparation for
Decontamination
Cleaning:
Automated
(Do NOT use ultrasonic washer)
It is recommended that devices are reprocessed as soon as is practical following use.
No particular requirements. Follow hospital procedures.
Review the washer-disinfector warning above, before using this cleaning method. Manually rinse attachments/tubes
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
Pre-Wash: Cold tap water, 2 minutes
Wash: 66°C, 5 minutes using a neutral enzymatic detergent, pH 6.0–8.0
Rinse: Hot tap water, 1 minute
21
Cleaning: Manual Wipe all attachments with a cloth, dampened with a surgical instrument cleaning solution.
Attachments and tubes may be mechanically agitated in cleaning solution, but not soaked or immersed.
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 and tubes.
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.
Move any moveable parts back and forth to allow solution to thoroughly clean attachment.
Rinse thoroughly with tap water.
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 Legend attachment cleaning nozzle (PA120) as this may cause some
attachments to overheat.
Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate attachments:
1. 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.
2. Articulate movable components to ensure proper lubrication.
3. Remove excess lubricant with a clean cloth.
Disinfection No particular requirements. 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.
Sterilization
(Temperatures are minimum
required, times are minimum
required)
Maintenance, Inspection and
Testing
Storage Store with other sterile devices.
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 as actually performed, using equipment, materials and personnel in the reprocessing facility,
achieves 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 conrmed with prions
or a Transmissible Spongiform Encephalopathy (TSE) such as Creutzfeldt-Jakob disease (CJD).
STERRAD Sterilization: Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal
diameter and length restrictions.
100% EtO Sterilization Parameters:
Preconditioning: 55–59°C, 70 ±5% relative humidity, 30 minutes
Temperature: 55–59°C
Relative Humidity: 70 ±5%
Ethylene oxide concentration: 725 ± 25mg/L
Gas exposure time (full-cycle): 4 hours
Aeration: 18 hours at 55–59°C
Liquid Chemical Sterilization: Do not use liquid chemical sterilants due to immersion procedure.
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.
Preventative Maintenance
For the Pneumatic Stealth-Midas System, MR7 System Preventive Maintenance Manual will assist you in getting the greatest ownership value from your Pneumatic
Stealth-Midas 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 specic steps necessary to maintain the Pneumatic StealthMidas System.
22
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 Pneumatic Stealth-Midas directly from Medtronic or from its aliate or its authorized distributor or representative. The
Pneumatic Stealth-Midas includes the motor with integrated tracker and hose.
i. Should a System Component fail to function to Medtronic’s published specications 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 specications 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 notied in writing within thirty (30) days following discover 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 Stealth-Midas
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 benet 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 conict with applicable law, the validity of the remaining portion of the Limited Warranty
shall not be aected, 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.
23
Symbols
REF
LOT
SN
STERILE
Brush
Control Unit
Adapter
STERILE R
!USA
Caution Air Pressure Relief Tube
Reference Number Use with United States federal law restricts this
device to sale by or on the order of a
physician.
Bone Mill
Lot Number
Quantity For single patient
Is approximately equal
to
Date of manufacture
Bone Mill Unlock
Regulator
Serial Number
use only. Do not
re-use, re-process, or
re-sterilize this product.
Re-use, re-processing
or re-sterilization
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.
Use by date
Regulator
Multi-Use Disposable Attachment
Instrument Case
Lubricant/Diuser
Dissecting Tool
Attachment
Multi-Use Disposable Attachment
Instrument Case
Lubricant/Diuser
Dissecting Tool
Attachment
Motor
Motor Lock
Brush On
Adapter O
USA Only Finger-Operated Control
Manufacturer Foot-Operated Control
Refurbished
Accessory
Non-Sterile
Control Unit
Sterilized Using Irradiation
Refurbished
Accessory
24
Do Not Dispose Of This
EC REP
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.
Tool Control Consult Instructions
Compliant with
European Council
Directive MDD 93/42/
EEC.
for Use
XX° C
>X° C
<XX° C
XX° C
Temperature Limitations
Authorized Representative in the
European Community
R
Angled attachment with
tracker oriented to the
right
L
Angled attachment
with tracker oriented to
the left
Dissecting tool compatible with StealthMidas Navigation
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.
Medtronic Powered
Surgical Solutions
4620 North Beach Street
Fort Worth, TX 76137
USA
medtronic.com
+1 800 643 2773
EC REP
Authorized Representative in the
European Community
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
+31 45 566 8000
manuals.medtronic.com
© 2016 Medtronic, Inc.
175034ML53 REV A
2016-08
Système pneumatique
Stealth-Midas™
Modèle: PM700N
Mode d’emploi
Les marques suivantes sont des marques commerciales ou déposées de Medtronic, Inc. aux États-Unis et dans d'autres pays: Stealth-Midas™, StealthStation™,
Midas Rex™, MR7™, Legend™, Synergy™, et O-arm™. Toutes les autres marques commerciales, marques de service, marques déposées ou marques de service
déposées sont la propriété de leurs détenteurs respectifs aux États-Unis et dans d’autres pays.