Augmedics Ltd • xvision-Spine User Manual Version 7 4.8.1. Roll Stand The optional variable-height Roll Stand with a VESA mount can be used for the optional AllIn-One Computer or optional Tablet Computer, described below. Figure 7: Roll Stand The roll stand is assembled when the system is set up for first time use. 4.8.2. All-In-One Computer You can use the optional All-In-One Computer to run the XVS SOFTWARE, which is installed when your system is set up for first use.
4. xvision-Spine Components 4.8. Optional Accessories The All-In-One Computer is intended to serve as a medical monitor which is designed for general purpose for hospital environment and for diagnosis. It could be used for Surgical, Radiology, PACS (Picture Archiving Communication Systems), LIS (Lab Information Systems) and Electronic Medical Record purpose. The All-In-One Computer can be attached to the VESA connector on the Roll Stand See All-In-One Computer User Manual on page I-1 for more information.
Augmedics Ltd • xvision-Spine User Manual Version 7 Note: Before snapping the detachable workstation to the optional HP ZBook x2 Protective Case attached to the Roll Stand remove the keyboard base from the tablet and set it aside. See Tablet Computer User Guide on page J-1 for more information. See Tablet Computer User Guide on page J-1 for additional warnings.
5. XVISION-SPINE System Installation and First Use When the system is delivered follow the procedures below. • Remove the components of the XVISION-SPINE (XVS) system from its packaging and inspect for damage. Document any damage with photos and make notes. Inform your sales representative of any damage the unit incurred during shipping. • Verify that all of the components are present.
Augmedics Ltd • xvision-Spine User Manual Version 7 5.1.2.
5. xvision-Spine System Installation and First Use 5.2. Accessory Assembly Instructions • At least one of the following inputs: • HDMI • DVI-D • SDI 5.2. Accessory Assembly Instructions Assemble and install accessories per DMR-XVS-SER-003. 5.3. XVISION-SPINE System Communication Communication is done via any Wi-Fi router that supports the IEEE 802.11g standard and is configured to support the XVS network. Configure communication as follows. 1. 2. 3. 4. 5. Turn on the computer.
Augmedics Ltd • xvision-Spine User Manual Version 7 Warning: The HEADSET is a personalized device which is calibrated to the user’s eyes and shall be used only by a user who performed screen-eye calibration by Augmedics authorized personnel. The HEADSET includes an adjustable head strap for self-adjusted optimal positioning. There are several user specific HEADSET designs (IPD, forehead-eye distance).
5. xvision-Spine System Installation and First Use 5.4. Custom-Fit the Headset to the Surgeon 1 2 3 4 5 6 Attach the battery. Power on the HEADSET by pressing the on/off button. Rotate the lock knob in a counterclockwise direction to unlock the hinges. Mount the HEADSET and adjust the head strap by rotating the rear knob. Make sure the front straps are positioned as indicated in the figure. Adjust the front part of the HEADSET to position the lenses in the correct distance and angle relative to your eyes.
Augmedics Ltd • xvision-Spine User Manual Version 7 5.5. Headset Pairing During installation of the XVS system the Augmedics technician pairs each HEADSET. Optionally, each HEADSET can be given a pairing name so that it can be more easily identified during XVS procedures. Figure 12: HEADSET Pairing Screen 1 2 3 4 1. 2. 3. 4.
5. xvision-Spine System Installation and First Use 5.6. Configuring the Scanner Imaging Protocol 1. 2. Click the imaging icon (A). Enter the following information (B) given from the scanner in the popup screen: • Name of Scanner (title to name the connection) • IP Address • AE Title 3. • Port Press Apply Connection (C). The scanner name appears above the scanner icon Caution: . Ensure that the firewall on the XVISION-SPINE computer is disabled.
Augmedics Ltd • xvision-Spine User Manual Version 7 • Setting up the Ziehm RFD 3D Scanner (page G-1) • Setting up the Siemens Cios Spin Scanner (page H-1) 5.7. XVISION-SPINE Footswitch Battery Installation The XVISION-SPINE Footswitch is powered by four AAA batteries. Follow the procedure below to install them. Figure 13: Insert Batteries into XVISION-SPINE Footswitch 1 7 6 5 2 4 3 1. 2. 3. 4. 5.
5. xvision-Spine System Installation and First Use 5.7. xvision-Spine Footswitch Battery Installation 6. 7. 8. If the blue LED illuminates the footswitch it means that the batteries have been correctly installed and that connection has been achieved. Replace the rubber pad and back panel. Lock the back panel in place with the four screws removed at the beginning of the procedure.
6. XVISION-SPINE System Preprocess Workflow Follow the procedures below prior to the surgical procedure. 6.1. Starting up the XVISION-SPINE System In the operating room launch the XVS SOFTWARE and power up the router and the HEADSET that is to be used in the procedure to automatically connect all of the devices. Before scrubbing in, mount the HEADSET when you are not sterile. Caution: The HEADSET is a non-sterile device and cannot be sterilized.
Augmedics Ltd • xvision-Spine User Manual Version 7 3. 4. For procedures using two HEADSETs select the second headset and key in an optional pairing name, as before. Click Save. Note: The HEADSET should be powered up at least ten minutes before the surgical procedure to enable it to reach its operating temperature. Continue with footswitch connection. Figure 15: Check Footswitch Connection A B Press the center switch (A) to test connectivity.
6. xvision-Spine System Preprocess Workflow 6.1. Starting up the xvision-Spine System The XVS SOFTWARE displays the main screen. Figure 16: New Study Screen A B C A New Study (A): use this when this is the first surgical procedure for a new patient. B New Study (Keep Tools): discard patient data but use the calibrations of the selected tools from the previous study. Useful if you need to do several scans on the same patient for different areas of the back.
Augmedics Ltd • xvision-Spine User Manual Version 7 Figure 17: New Study Menu Note: In rare cases the monitor display may not be seen while wearing the HEADSET. In this case tilt your head by a few degrees to the left or right to restore visibility of monitor display. See New Study on page 7-1 for more information. 6.2. Prepare Surgical Tools The system supports up to six navigated instruments per a single procedure. Contact Augmedics Ltd regarding supported tools.
6. xvision-Spine System Preprocess Workflow 6.2. Prepare Surgical Tools Warning: The XVISION-SPINE system is not compatible with bent instruments. Using bent or damaged instruments may affect system accuracy. Verify that the instrument is not bent or otherwise damaged. Universal Tool Adaptors Figure 18: Prepare Surgical Tool for Universal Tool Adaptor 1 6 5 4 3 2 1 Remove the appropriate instrument marker from the sterile packaging and set it on the 2 3 4 5 6 universal tool adaptor.
Augmedics Ltd • xvision-Spine User Manual Version 7 Navigated Tool Adaptors Figure 19: Prepare Surgical Tool for Navigated Tool Adaptors 1 5 4 3 2 1 Remove the appropriate instrument marker from the sterile packaging and set it on the 2 3 4 5 6-6 navigated tool adaptor. Use the hex screwdriver to tighten the instrument marker to the navigated tool adaptor. Insert the surgical instrument. Hold the navigated tool adaptor where indicated.
6. xvision-Spine System Preprocess Workflow 6.2. Prepare Surgical Tools VP Tool Adaptors Figure 20: Prepare Surgical Tool for VP Tool Adaptors 4 3 1 2 1 Remove the appropriate instrument marker from the sterile packaging and set it on the vp tool adaptor. 2 Use the hex screwdriver to tighten the instrument marker to the vp tool adaptor. 3 Align the surgical instrument. 4 Tighten the vp tool adaptor to the instrument using a 3 mm Allen key (not supplied).
Augmedics Ltd • xvision-Spine User Manual Version 7 Continue with the other adaptors that will be used in the procedure (up to six). 6.3. Surgical Instrument Calibration Each navigated surgical instrument must be calibrated before use. Note: It is recommended to calibrate tools 20 minutes after the HEADSET has been powered up and paired. After the tool calibration, the HEADSET will remain powered up and paired.
6. xvision-Spine System Preprocess Workflow 6.3. Surgical Instrument Calibration Figure 21: Calibrate Tools 12 6 3 5 4 1 Select TOOL CALIBRATION from the XVS SOFTWARE. 2 Select the HEADSET to be used for calibration. Note: The HEADSET is listed by its serial number or its pairing name. See Headset Pairing on page 5-6 for more information. 3 Select a surgical instrument to be calibrated.
Augmedics Ltd • xvision-Spine User Manual Version 7 Note: None of the names is specific, except for the Screwdriver. If the generic name is not appropriate, choose Other. 4 Take one of the prepared surgical instruments and touch the tip of the tool to the calibration point on the patient marker. 5 Press the Start button (located on the bottom left of the screen) and swivel the tool, keeping the tip on the point.
6. xvision-Spine System Preprocess Workflow 6.4. Screwdriver Calibration Figure 22: Calibrate Screwdriver 12 3 7 6 5 4 1 Select TOOL CALIBRATION from the XVS SOFTWARE. 2 Select the HEADSET to be used for calibration. Note: The HEADSET is listed by its serial number or its pairing name. See Headset Pairing on page 5-6 for more information. 3 Select Screwdriver and screw length. 4 Take the prepared screwdriver and touch its tip to the calibration divot of the patient marker.
Augmedics Ltd • xvision-Spine User Manual Version 7 5 Swivel the tool, keeping the tip on the point, until calibration reaches 100%. Note: The surgeon can monitor progress on the HEADSET display. 6 When calibration is 100% place the screwdriver perpendicular on the patient marker as 7 marked in the HEADSET display. Wait for the Calibration Succeed message Calibration Succeed before continuing. Press Swivel Test to verify that the tool is not bent and follow the procedure below. 1. 2. 3. 4.
6. xvision-Spine System Preprocess Workflow 6.5. Patient Registration Using Spine Clamp Warning: Do not over-tighten the patient clamp, as this may damage the spinous processes. Warning: Verify that the clamp is closed tightly enough on the spinous processes so that it does not move during the surgical procedure. Note: The available working area is five levels beyond the base of the clamp. Patient clamps are reusable components of the XVS system.
Augmedics Ltd • xvision-Spine User Manual Version 7 Figure 23: XVS Straight Clamp 1 2 3 4 1 Insert the allen screwdriver into the adjustment screw of the XVS Straight Clamp. Caution: Take care to use the aperture located to the side of the clamp. Attempting to tighten the central aperture, used for the patient marker, may damage the XVS Straight Clamp. 2 Turn the allen screwdriver in a counter-clockwise direction to open the clamp jaws.
6. xvision-Spine System Preprocess Workflow 6.5. Patient Registration Using Spine Clamp XVS Arc Clamp Warning: The XVS Arc Clamp configuration is to be used only during open spine procedures. The recommended direction is to place the clamp in the cranial to caudal direction with the pointed end pointing caudally. Figure 24: XVS Arc Clamp Attachment 1 2 3 4 1 Insert the allen screwdriver into the adjustment screw of the XVS Arc Clamp.
Augmedics Ltd • xvision-Spine User Manual Version 7 6.5.2. Patient Registration Patient registration is the process whereby the XVISION-SPINE system orients the transformation between the patient scan and the patient marker. Note: The recommendation of manufacturers of intraoperative scanners is to take care that, during a scan, the patient does not move, the patient is not moved, and that the patient’s breath be held. Otherwise the 3D image reconstruction may contain errors.
6. xvision-Spine System Preprocess Workflow 6.5. Patient Registration Using Spine Clamp 1 Attach the Z-Marker to the patient clamp with the allen screwdriver. Choose either the ZMarker-60 or Z-Marker-40 so it will be as close as possible to the surface of the patient’s body. Note: Make sure that the Z-Marker does not touch the patient’s skin. 2 Initiate an intraoperative 3D scan of the area, verifying that the desired spine anatomy and 3 4 the Z-Marker are included in the scan.
7. Spine Surgery with the XVISION-SPINE System When all preprocess tasks have been completed continue with preparing the surgical procedure at the computer where the XVS SOFTWARE is installed. 7.1. New Study Use the New Study screen to finalize all procedures for the surgical procedure. Typically, at the end of the intraoperative scan, 3D data is sent directly to the computer where the XVS SOFTWARE is installed.
Augmedics Ltd • xvision-Spine User Manual Version 7 7.2. Create 3D Model With a completed registration tap Create 3D Model. Figure 27: Create 3D Model A D C Note: B For touch screens, the technician uses standard pinch and swipe gestures to manipulate the model (A), including pan, zoom in/out, and rotate rendered data. The window level (B) is used to set threshholds for the image to eliminate everything but bone tissue. When the image is satisfactory tap Create Model (C).
7. Spine Surgery with the xvision-Spine System 7.3. Beginning the Surgical Procedure Figure 28: Create Mesh A Thresholds B Amoeba button to erase scan artifacts C Save the model D Back to previous screen The bounding box around the mesh can be adjusted to remove artifacts by rotating it and then pressing one of the orange handles to crop out unneeded data. When the mesh shows the spinous process as clearly as possible tap Save. The save process may take several minutes. Then press Start Procedure. 7.3.
Augmedics Ltd • xvision-Spine User Manual Version 7 Note: During the surgical procedure the HEADSET should remain between 30 cm and 70 cm above the tracked instruments. Note: Return the HEADSET image view by moving the head when you are out of working limits.
7. Spine Surgery with the xvision-Spine System 7.3.
Augmedics Ltd • xvision-Spine User Manual Version 7 7.3.1. Headset Controls The technician in the operating room uses the controls below according to the verbal instructions of the surgeon during the procedure. Caution: If the HEADSET fails a message appears on the HEADSET and the system monitor. In this case use a different HEADSET. Caution: In case of loss of image in either or both eyes use a different HEADSET.
7. Spine Surgery with the xvision-Spine System 7.3. Beginning the Surgical Procedure Figure 30: Headset Controls A B J C D I E F G H Area Name Notes A HEADSET status • • B HEADSET device name See Headset Pairing on page 5-6 for more information C Tip View Cuts/removes layers according to where the tip of the surgical instrument is located D Transparent Model Available only on HEADSET E 3D Off Slice view only F 3D Follow Region interest follows the tool.
Augmedics Ltd • xvision-Spine User Manual Version 7 Area Name Notes G 3D Fixed Show fixed 3D and 2D (slice) displays (according to HEADSET movement) Warning: The 3D Fixed mode is not intended for use in open surgeries and shall only be used in minimally invasive surgeries.
7. Spine Surgery with the xvision-Spine System 7.3. Beginning the Surgical Procedure 7.3.2. Footswitch Controls The surgeon can control the following XVISION-SPINE software functions using the Footswitch.
