O-arm® Imaging System Supplemental Guide Indications for Use
Contents
1. Storing the 2D Image to the Session File To store the captured image The one that appears on the left side of MVS to the patient s session press the store button on the appropriate button on the hand switch or footswitch Saving Gantry Positions and Image Settings as Memory Presets To save gantry position and image quality settings for a 2D shot press M on the pendant and then a preset button 1 4 The preset LED lights up These settings are saved until you start a new imaging session To overwrite a preset press M and then the preset button again Gantry positions can only be saved while in 2D mode Note It may help to write down on note cards which positions and settings are saved to which presets i e M1 AP M2 Lateral Note Presets only apply during a single session Note Presets save the gantry position relative to the cabinet of the O arm System not to the anatomy If you reposition the entire system the presets will no longer apply to the anatomy Saving a Park Position Position the gantry as far out of the way left right as possible without compromising line of sight to the reference frame and instru ments if using a StealthStation System camera Wag or tilt the gantry as appropriate in whatever direction gives the surgical team better access Press M on the pendant and then the P preset button 8 O arm Imaging System Supplemental Guide2. the patient position the gantry so that the patient is as far as possible from the X ray tube Note The short set of LEDs in the gantry light ring denotes the position of the X ray tube the long set of LEDs denotes the position of the detector 1 Use the Pendant buttons to position the gantry around the patient so that the patient is as far as possible from the X ray tube for each shot angle A Make sure the system is in 2D mode press 2D button at top of Pendant Set pendant control Auto Brightness Control ON whenever possible To take the image press on the hand switch or foot switch to take a standard shot or Oy for a high definition boost shot if the anatomy is particularly dense f Note high definition fluoro boost is a higher radiation dose Always consider patient radia tion exposure before increasing dose Make a long enough exposure to allow the auto brightness feature to stabilize Watch your image on the MVS and terminate expo sure when an acceptable image is displayed Make any adjustments necessary to achieve desirable image quality see page 11 for Tips Improve 2D Image Quality Figure 7 Positioning for a PA shot top ora lateral shot bottom 2D 3D Image Acquisition uolsinboy abew dz 10 Taking 3D Images 1 2 O arm Imaging System Supplemental Guide 5 Ifthe 3
3. you Be Ge must press and hold the button until the gantry has Note Do not extend it completely Leave a completed the entire desired range of motion margin of about 4 inches in case you need to 1 Press and hold the Up arrow on the up down extend it further once it is around the table control 1 to undock the gantry 3 Open the gantry door 5 No other positioning button will function until If you are going to drape the gantry do so now the system is undocked See Draping the Gantry If you are going to leave the gantry around the table during the procedure and want to set a park position offset the gantry to the side opposite where you will park it left right 4 Drive the system forward to bring it around the table LOOK carefully as the O arm System is brought around the table Other OR personnel should watch and assist to make sure that the system does not contact the patient table booms drapes tubes etc as you bring it into place D 5 Once the gantry is around the table and Figure 6 Pendant controls h patient close the gantry door 3 finish the for initial positioning draping procedure as you do so if you are 3 using the tube drape Have others watch and assist to make sure that the door closes without contacting or pinching anything Gantry Motion Ranges Up Down 18 total range Note Maximum down range only reachable when gantry extended beyond base
4. 14 Viewing 3D Images Using O arm Imaging System Oblique Slicing optional feature angle you selected The adjustment angle is limited to 45 a a Zero Key On The Alpha Keypad To reset the image to the original oblique slice press the zero key 2 on the alpha keypad 0 soo Figure 14 3D Oblique Slicing Image O a gt Medtronic O arm Imaging System Supplemental Guide Archiving Reviewing Archiving and Deleting Patient Studies Completed imaging sessions are stored on the Saved Exams page Figure 15 Opening a patient exam and session in Saved Exams To open images from a session to view on the MVS 1 2 15 Double click on the patient s name then double click on the imaging session Find the image set in the preview area and double click to open it A 3D set loads and opens in a 3 in 1 view in the MVS monitor See pages 13 and 14 A 2D image or snapshot opens as a preview in the left hand pane of the MVS monitor Archiving Ie c gt To open the Annotation Editor to annotate 2D images stitched 2D images or snapshots press lt A gt on the keyboard E c To stitch up to nine 9 2D images together select them all in the imaging session Press and hold lt Ctrl gt click on each image and then press lt Stitch Image gt to open the first screen for image stitching For further information on stitching images refer to the O arm User
5. Figure 20 Memory preset buttons Moving the O arm System laterally 1 3 Press the lift and shift button 4 to lower the wheels that allow lateral movement When the lift and shift wheels are down the system emits a regular chirp This alert is to remind you that having the lift and shift wheels lowered drains the battery Move the O arm System to the desired position As soon as the system is where you want it press the lift and shift button a second time 19 N D Ban By YW 2 Ta S 5 WwW c suomun snoaue arsiy 20 Troubleshooting Transferring Images O arm Imaging System Supplemental Guide 3D Image does not transfer to StealthStation Navigation System 1 Check for the green check mark beside an image of the StealthStation camera on the O arm pendant prior to 3D acquisition to ensure readiness of the StealthStation 2 Maintain hand or foot switch contact during entire 3D acquisition or image data may be lost 3 Ensure that the StealthStation and O arm Systems are connected via a network cable and that they remain connected until the images have transferred completely to the StealthStation System 4 Do not unplug the interconnect cable between the O arm System and MVS immediately after acquiring an image or data may be lost wait until data transfer is confirmed at the MVS before detaching the cable 5 Check that the St
6. Guide Puy 16 O arm Imaging System Supplemental Guide To archive patient data 1 Insert your external media or connect to the network or system to which you are exporting images 2 On the Saved Exams page select an entire patient record an imaging session or an image set You can also click on the thumbnail for a Dose Report to save it 3 Click Send To 4 In the dialog that opens select the radio button for the export media device To save the data to a CD or DVD select CD ROM to save it to a USB drive select Removable Storage Device 5 Under Options select either Send Patient Images Send Snapshots or both Note You cannot export snapshots across a network If you do not want patient information to appear on the transferred images select Anonymize 6 Click Send A popup indicates the progress of the transfer To delete patient data 1 Select the patient s name in the Saved Exams page 2 Highlight the exam to delete 3 If the Prevent Deletion box is checked for that exam un check it 4 Click Delete Patient Figure 16 The Send To dialog to export data O O 17 a gt Medtronic O arm Imaging System Supplemental Guide Radiation Safety Emergency Procedures Radiation Side View z Figure 17 During Safety 3D spin acquisition Personnel personnel who remain oe in the room should Positioning be at either end of the gantry two 2 meters away and protecte
7. fiber non metal surgical table Removing all unnecessary metal leads wires instruments from the surgical field In spine procedures performing the 3D scan before rods are inserted reduces metal artifact Filling the surgical opening with saline solution prior to initiating a 3D exposure a m Figure 9 For 3D Images patient anatomy Pausing patient respiration during the time should be isocenter in the gantry of image acquisition about 20 seconds for standard exposure O 11 gt Medtronic O arm Imaging System Supplemental Guide Imaging Tips and Tricks Tips to Improve 2D Image Quality With Auto Brightness ON you can improve contrast by using the Region of Interest softkey CD to select an area dashed green line inside the image on which automatic brightness and gray scale will be based Note Each successive press of the ROI softkey reduces the size of a green frame within the image Once ROI reaches its smallest size pressing the ROI softkey again restores it to full size If a patient has poor bone density you can improve contrast by disabling Auto Brightness 2 and using the up down arrows on the kV softkey 3 to control technique manually The mA settings track the kV settings automatically Adjust contrast and brightness of an image using the contrast and brightness buttons Collimate as appropriate using the collimation buttons 5 The center button resets the apertu
8. gantry settle into the corresponding holes in the platform Figure 3 Pendant display when M VS DIL gged in Figure 4 Pendant display when MVS NOT plugged in Turn off the MVS Disconnect the MVS from the power outlet Move the O arm System and MVS to their storage location e Once you ve reached the storage location plug the MVS into a power outlet and re connect the interconnect cable between the MVS and O arm System Verify that O arm System is charging battery indicator lights scrolling Turn off the O arm System Cleaning the System To clean the system cover panels and cables wipe them with a cloth dampened with a suitable disinfectant Avoid use of phenol based corrosive or solvent disinfectant agents that may harm system surfaces If you are not sure of the properties of a disinfectant agent do not use it P Be careful not to drip or splash any liquid into the interior of the system x ie Pa a ES _ a a S Medtronic O arm Imaging System Supplemental Guide Entering Exam Information O arn Positioning Entering Exam Data Once the system powers on the Exam Information page opens on the MVS console If it is not open press lt ESC gt on the keyboard to open it Entering Data Before a Session Enter data in as few or as many of the fields as you wish You do not have to fill in any data to start an imaging session Imaging sessions started without any exam data enter
9. D image is to be used for surgical D navigation check now that The O arm MVS is connected to the StealthStation System and the systems are communicating green check mark on Pendant The StealthStation software is on the Figure 8 Acquire Scans screen and the status 3D mode bar is green softkeys The StealthStation System camera can see the reference frame on the patient Put the system in 3D mode Press 3D button and the O arm tracker at top of Pendant 6 Make sure all personnel are positioned outside Select each of the following to match the the room to minimize radiation exposure or intended imaging using the Pendant are using lead protective gear before you Softkeys Figure 8 initiate 3D image acquisition see Figure 17 Patient Orientation L R Prone Supine Press AND HOLD t Gy button neal ae Anatomy Imaged head thorax abdomen the hand switch or foot switch and extremity a KEEP HOLDING THE BUTTON PEDAL for the complete duration of the spin until the exposure is complete and you no longer hear principles audible beeping Patient Thickness S M L XL Dose Standard or HD3D high definition Note always consider AL before increasing dose Note You can further adjust find mA as needed to get optimal image qt Position the gantry so that the patie at is isocenter see Figure 9 i Doing the following if appropriate can improve 3D image quality Using a carbon
10. O E Technical Support a gt Medtronic 800 595 9709 Toll Free 720 890 3160 Local and International O arm Imaging System Supplemental Guide Indications for Use The O arm Imaging System is a mobile X ray system designed for 2D fluoroscopic use and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high X ray attenuation such as bony anatomy and metallic objects The O arm Imaging System is compatible with certain Image Guided Surgery Systems DISCLAIMER Users should be familiar with the User Manual prior to operating the O arm Imaging System Please refer to the O arm User Manual BI 500 00142 for warnings and precautions related to the safe use of the system Innovating for life Technical Support a gt Medtronic 800 595 9709 Toll Free 720 890 3160 Local and International O arm Imaging System Supplemental Guide Indications for Use The O arm Imaging System is a mobile X ray system designed for 2D fluoroscopic use and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high X ray attenuation such as bony anatomy and metallic objects The O arm Imaging System is compatible with certain Image Guided Surgery Systems DISCLAIMER Users should be familiar with the User Manual prior to operating the O arm Imaging System Please refer to the
11. O arm User Manual BI 500 00142 for warnings and precautions related to the safe use of the system Innovating for life o Note While driving the system be careful not to contact doors other equipment or people Make sure that it does not run over cables on the floor its weight can crush them sng Bathory I dy Charging ogo v E i if Hi i Note Line up the red dot on the cable end with the red dot on the cable port Note Make sure the battery charge indicators on the O arm System power panel are scrolling If they are not check the cable connection and line power to the MVS aberos dnias S h utti ng Down and O arm Imaging System Supplemental Guide Storing the System 1 When the O arm System is no longer needed in the procedure open the gantry door completely YOU A and prepare to move the system away from the table LOOK to make sure the paths of the O arm System and the gantry are clear of any cables tubes wires bars booms equipment personnel and patient drapes before you move the system away from the table key area of concern is clearance under the table Disconnect the cable between the MVS and O arm System Wrap it around post of MVS Pm Dock the O arm gantry always put it in docked position before you transport or store it c To dock the gantry PUSH AND HOLD the Dock button 1 on the Pendant until the docking pins beneath the
12. a gt Medtronic O arm Imaging System Supplemental Guide Installing the Tube Drape The Tube drape is part number 9732722 Check the revision number on the package and follow the instructions that apply Before you begin open the door of the gantry 1 Remove the drape from the sterile pack and place it on a sterile table with the left hand label up and facing you 2 Grip the drape under the fold beneath the Left hand label with your left hand and unfold it to the left and then grip the drape under the Right hand label fold with your right hand and unfold it to the right 3 Unfold the top fold of the drape toward you 4 Following the hand indicators put your hands into the drape main fold 5 Raise your hands and lift the drape up allowing the drape to hang open in front of you Note for best results don t grip the drape just tilt your fingertips up as you lift f Installing Tube Drape adeig aqny buljjeisuy OR Va soles Imaging System Supplemental Guide Installing the Tube Drape continued 6 7 Walk to the opening of the gantry and hold the drape so that the opening aligns with the upper part of the gantry A non sterile assistant takes ahold of the drape at a GRIP HERE tab on one side of the gantry and pulls the drape over the top of the gantry to the positioner following the THIS END OVER UNIT indicator It helps if another non sterile assistant does this at the same time on t
13. ainy 1 Make sure size and anatomy selections match patient size and anatomy 2 Increase mA until desired image quality achieved 3 Use HD acquisition as appropriate adjusting mAs to match standard scan technique Anatomy cut off in image 1 Open collimation to see anatomy 2 Reposition anatomy to the center of the imaging panel O 13 O arm Imaging System Supplemental Guide Figure 12 Manipulating 3D image sets Full Screen View Right button click Lightbox view MIP view Desired Action Mouse or Touch Pad action To shift the active pane yellow frame through the Press the left button on the mouse or images axial coronal sagittal keyboard touch pad To scroll through the images Turn the mouse wheel or press the up down buttons on the keyboard To cycle the image display between Press the right button on the mouse or key e default 3 in 1 board touch pad e full screen display of the active image e lightbox presentation To switch to MIP view Press both left and right buttons together With the MIP view displayed With the MIP view displayed To rotate the MIP view around the selected axis Press the right or left arrow on the To toggle the rotational axis between vertical keyboard or turn the mouse wheel and horizontal Press the left touchpad or mouse button Innovating for life Manipulating 3D Reconstructions SUOI INJISUOIAY QE bunejndiueyy
14. d by a barrier of not less than 0 5mm of lead Radiation Safety Patient Dose When imaging with the O arm System always follow ALARA guidelines for patient radiation exposure ALARA As Low As Reasonably Achievable e Reduce exposure time whenever possible e Position the patient for lowest exposure with highest image quality see page 9 e Use the lowest exposure dose that gives adequate image quality Radiation Dose Rep OF S To view the current dose report 1 Open the Exam Info page 2 Click on Dose The current dose report oper s in the left hand window c To save the report to the exam database and close it click Save and Close c gt To close it without saving click Close Y to the exam database 9 the latest data Note The system saves an image of the current repe If the report changes save it again to have a copy Wit it does not automatically update Fluoro Dose Mode of Op Exposure Time sec Exposure mGy DAP a cm2 Figure 78 Fluoro ee nico High Level Fluoro 13 09 7 Sample dose 45 11 16 65 report A 3D Dose ID Kp mAs __ CTDI mGy DLP mGy cm Phantom cm 3D 1 120 00 93 75 11 91 190 42 Head 16 3D 2 120 00 195 50 14 08 225 13 Body 32 a S 415 55 O CL Ayayes uoneipey sainpsd01q Huap Emergency Procedures Emergency Stop and Emergency Stop Reset There are two Emergency Stop buttons One on the O arm System control panel the other on the P
15. ealthStation System has sufficient hard drive capacity If it is above 80 full delete studies and re send the current study from the O arm system Image Transfer Issues across a network e Network connections can be made either before system is turned on or after it has completely booted up Make sure that the network cables are secure in the ports Note The system should not be connected to the network during a surgical procedure e Axial images are the only ones that can be transferred to PACs at this time coronal images and sagittal images cannot be transferred e Snapshots are in TIFF format They cannot be saved to PAC systems that do not accept TIFF files Re home Recalibration of Mechanical Robotics On occasion the O arm System will need to have its robotics recalibrated The system alerts you of the need to do this and displays messages guiding you through the procedure 1 Before you begin move the system away from any patient table or other equipment since the system will reposition the gantry through its full range of motions 2 Press the M button on the Pendant This is the same M button used for Memory presets 3 Hold the M button down until the system has performed its mechanical activities O arm System does not move even though the system is on Check to see if clutch is engaged At lower left of O arm System cabinet Lever should be in the DOWN position for motorized transport 0 www medtronicnavigati
16. ed are saved by their date and time stamp Use the touch pad to move the cursor or use the lt Tab gt key on your keyboard to move between fields When you have entered all the data you want click Accept to start the imaging session or New to save the data to the Scheduled Exam list e ae ay i F i r Finding and Editing Patient Data for Completed Sessions Completed imaging sessions are saved under Saved Exams most recent exam listed first Imaging sessions started without any exam data entered can be identifed by their date and time stamp You can edit the exam information for a patient by opening their session under Saved Exams and clicking Edit Opening Dafa for Scheduled Sessions Fo To open patient exam info for a scheduled exam data saved or imported earlier find the patient s name in the list under Scheduled Exams Double click on the patient s name to open it in the Exam Information screen and _ press Accept to start the imaging session Figure 5 Exam Information Page Entering Exam Information 0 arm Positioning Huluolisog W1e 0 UONeWOJU wex Bunau Positioning the O arm System O arm Imaging System Supplemental Guide and Gantry For storage and transport the gantry should bein 2 Extend the gantry 2 away from the cabinet the docked position until you can see the pinch hazard labels on Note for all pendant controls except Lift and Shift
17. endant e When pressed these do NOT shut off the entire system they only stop battery driven motions and X ray imaging functions e They may be used either in an emergency if the system were to act in an unexpected way or they may be used as a fail safe to prevent unintended actuation of the drive wheels or the X ray functions e To return the system to full functionality after pressing Emergency Stop press the Emergency Stop Reset button Emergency Gantry Door Opening If the gantry door does not open upon pressing the Door Open button on the pendant __ first try the electronic override if the door remains stuck try the manual override Electronic Override Locate the yellow Door Override button onthe side of the gantry right side if gantry viewed from cabinet end Press the yellow door override button AND the door open button onthe pendant simultaneously Note you can swing the Pendant around on its pivot as shown in image below to allow you to reach both buttons at the same time Manual Override Step by step directions on opening the gantry door are in the right side pocket of the MVS attached to the T shaped Rotor Alignment Pin Follow the step by step directions to open a stuck gantry door ays fem Enab in a ly o ol Figure 19 Buttons for Emergency stop and reset and gantry door opening Battery Raty Changng Levees O S Medtronic Miscellaneous Functions
18. he other side At the positioner end of the gantry there is a piece of tape with backing The non sterile assistant removes the tape backing and applies the tape to the positioner near the top If the side folds of the drape are held up by tabs break the tabs and let the drape hang down There are also pieces of tape on the bottom of the side folds that can be used to attach the drape to the underside of the gantry 10 Have the operator position the gantry over the patient 11 Sterile Break the perforation between the green arrows on the two 2 door tear tabs and gently shake the drape folds out 12 Have the O arm operator start to close the gantry door while the sterile person holds the drape so that it hangs down just below the closing door Note as the door closes communicate with the operator to stop closing it at any time that there is danger of the drape snagging or tearing 13 As the door reaches the bottom part of the gantry a non sterile assistant makes sure that the drape opening fits around the lower portion of the gantry and is kept clear of the door as the door closes A gt Medtronic O arm Imaging System Supplemental Guide Installing the Tube Drape continued 14 The sterile person now tapes up the drape slack If you are using the O arm system with a StealthStation navigation system do this on the side of the gantry opposite to where the StealthStation camera will be positioned during imagi
19. ng To tape up the slack break the perforation between the green arrows on the poly ties remove the tape backing near the bottom of each tie and use the tape to cinch up the excess drape Installing Tube Drape adeiq eqn bulAoway 1 2 ei nae ur s gt Removing the Tube Drape Sterile person Release the poly ties that are holding up the drape slack At the door end of the gantry is a TEAR AWAY AFTER USE sticker that indicates a fine perforation in the drape The sterile person holds the drape above the perforation to keep it in place while the gantry door opens Once the gantry door is fully open a non sterile person tugs downward to tear at the end Sterile person rolls up the upper portion ofthe drape while taking care not to contact the contami nated drape interior Tip Putting on a second pair of gloves before doing this reduces chance of contamination and allows you to use the remo ed outer glove to secure the rolled up drape Stuff the rolled drape into the opening in the top of the gantry door Have the operator remove the O arm System from the sterile field Once the system is clear of the sterile field remove the tape on the rear cabinet and pull the drape off of the gantry O S Medtronic O arm Imaging System Supplemental Guide 2D 3D Image Acquisition Taking 2D Images For each 2D shot to maximize image area increase sharpness and reduce radiation dose to
20. on com Medtronic Navigation 826 Coal Creek Circle Louisville CO 80027 A Toll Free 877 242 9504 Medt Telephone 720 890 3200 faejil e Fax 720 890 3500 9670995 O arm Imaging System Supplemental Guide Medtronic Navigation Inc 2012 All Rights Reserved Printed in USA
21. re to fully open Note Please be aware that the settings for collimation using 2D memory preset 4 will translate to your 3D Spin Figure 10 Left pendant keys for adjusting image quality above left uncollimated image above middle collimation applied to image above right ROI applied to image dashed green lines Imaging Tips and Tricks Syd pue sdi buibew 12 Troubleshooting Taking Images Unable to get a 2D image 1 Are you in 2D mode If not select 2D button at top of Pendant NUY SAU 2 Did you press the or O button on the hand or footswitch This is how you activate imaging 3 Is the Emergency Stop button 2 activated If so press the RESET button 4 Has the X ray On Off button been pressed If so press it again to restore X ray function 2D Image Not Penetrated No detail or anatomical definition A Hold hand switch button down for longer exposure e If that doesn t work take shot again using boost button Xo sh 2D Image Overexposed tc ok right Once AutoBrightness is off dec ease kVp or mA to desired brightness Figure 11 The Pendant O arm Imaging System Supplemental Guide 2D Image is Grainy 1 Activate X ray hand switch or foot switch button long enough for a good exposure 2 Use collimation and adjust ROI see page 11 3 Adjust Noise Reduction softkey as needed to reach desired smoothness 3D Image is Gr
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