Augmedics Ltd • xvision-Spine User Manual Version 7 7.4. Tool Verification When a new tool enters the area the system requests tool verification. The surgeon sees a red notice on the HEADSET. Note: Tool verification is required for the screwdriver every time a new screw is attached to the tool. Figure 32: Tool Verification 1 2 1 Touch the tip of the surgical instrument to the v-point on the body clamp. 2 Swivel the surgical instrument, keeping the tip on the v-point.
7. Spine Surgery with the xvision-Spine System 7.5. Landmark Check 7.5. Landmark Check When the surgeon has verified the first tool a landmark check is done to verify that the XVISION-SPINE system is correctly interpreting the location of the tool tip.
Augmedics Ltd • xvision-Spine User Manual Version 7 Figure 34: Landmark Check Screen A Workstation View B Headset View Touch a known anatomical spot, such as a particular vertebra, or a part of the vertebra, with the tip of the tool. If the physical location of the instrument and the display of the XVISIONSPINE monitor (A) and the HEADSET (B) match, the surgeon instructs the technician to tap Verified. Note: The landmark check is required only on the first tool after verification. 7.6.
7. Spine Surgery with the xvision-Spine System 7.6. Virtual Target Guide Figure 35: Setting the Virtual Target Guide 1 2 3 1 Using the navigated tool, the surgeon touches the tip of the surgical instrument on any part 2 3 of the patient’s anatomy. The surgeon then presses the right pedal, or instructs the technician to tap the Target button. A new virtual target appears. It is composed of 20 yellow rings of the same diameter.
Augmedics Ltd • xvision-Spine User Manual Version 7 Figure 36: Using the Virtual Target Guide 1 Workstation View Headset View 1 When the tool is placed within the field of view it appears on the visual display.
7. Spine Surgery with the xvision-Spine System 7.6. Virtual Target Guide 2 Workstation View Headset View 2 Bring the tool to the first yellow ring to align it with the trajectory. As the tool moves down the trajectory the rings change to a green color. Continue moving the tool along the virtual trajectory until all of the rings are green. Note: Pressing the Target button when fewer than three loops are colored green results in adding another target.
Augmedics Ltd • xvision-Spine User Manual Version 7 The surgeon now has a virtual trajectory guide that can be used to insert another surgical tool at the same location. Figure 37: Inserting a Screw Using the Virtual Trajectory Guide 1 Workstation View Headset View 1 Align the screw along the virtual trajectory guide and insert it.
7. Spine Surgery with the xvision-Spine System 7.6. Virtual Target Guide 3 2 Workstation View Headset View 2 When the screw has been inserted the technician taps the screw icon to release to the tool.
Augmedics Ltd • xvision-Spine User Manual Version 7 4 5 Workstation View Headset View 4 As screws are inserted they appear purple in the workstation view and headset view.
7. Spine Surgery with the xvision-Spine System 7.7. Ending an xvision-Spine Procedure To remove a virtual target do the following. Figure 38: Remove Virtual Target and Virtual Screw A • Click the target. When it turns red (A) click it again. or • Move the tool inside the green funnel and click the target or the footswitch. 7.7.
Augmedics Ltd • xvision-Spine User Manual Version 7 Figure 39: Removing the XVS Spine Clamp 1 2 3 1 Remove the patient marker from the patient clamp using the allen screwdriver and discard it. 2 Loosen the patient clamp using the allen screwdriver and set it aside for cleaning and sterilization. Note: In some cases the patient clamp cannot be loosened using the allen screwdriver. In this case continue with Clamp Removal Tool (page 7-20).
7. Spine Surgery with the xvision-Spine System 7.7. Ending an xvision-Spine Procedure Note: The clamp removal tool releases a screw in the patient clamp and renders it obsolete. The patient clamp cannot be reused. Figure 40: Clamp Removal Tool 1 2 3 4 5 6 7 1 2 3 4 5 6 7 Rotate the handle of the clamp removal tool in a counter-clockwise direction. When the jaws are open sufficiently, place the clamp over the patient clamp. Rotate the handle in clockwise direction until the clamp is fully closed.
8. Cleaning Reusable Components Follow the procedure below to clean the reusable components of the XVISION-SPINE system: • Patient clamps (XVS Straight Clamp, XVS Arc Clamp) • Universal Tool Adaptors • Allen screwdriver • Z-Markers • Navigated Tool Adaptors • XVS adaptors • XVS wrench • Clamp Removal Tool • VP Tool Adaptor All reusable components must be thoroughly cleaned and sterilized before initial use and after each subsequent use.
Augmedics Ltd • xvision-Spine User Manual Version 7 Figure 41: Cleaning Patient Clamp A C B A Clamp pin B Set screw C Hinge pin Figure 42: Cleaning Tool Adaptor Apertures Take care to clean all surfaces. Use the following washer cycle.
8. Cleaning Reusable Components 8.2. Steam Sterilization Phase Recirculation Time (minutes) Temperature Detergent Type and Concentration (if applicable) Pre-rinse 1 02:00 Cold utility water N/A Wash 1 02:00 43 °C utility water Valsure® Neutral Detergent (US) at 2.0 mL/L or Neodisher® Mediclean Forte (EU) at 2.0 mL/L Rinse 1 1:00 Cold utility water N/A Pure Water Rinse 1:00 43 °C criticalI water N/A Dry Time 07:00 115 °C N/A 8.2.
Augmedics Ltd • xvision-Spine User Manual Version 7 Caution: Do not attempt to sterilize any part of the HEADSET. Any attempt is likely to cause damage to the HEADSET and its components. Note: Whenever possible, do not allow blood, debris, or any body fluids to dry on instruments. For best results, and to prolong the life of the HEADSET, process immediately after use.
8. Cleaning Reusable Components 8.3. Cleaning and Disinfection of the Headset 1 Wearing disposable gloves, turn off the power switch of the HEADSET. 2 Disconnect the battery socket from the HEADSET. 3 Remove the battery. For more information see See Battery and Charger on page 4-3 for more information. 4 Remove the three pads attached to the inner portion of the HEADSET and clean them with 5 6 7 8 CaviWipes METREX™ to remove blood stains or other contaminants. Allow the pads to air dry.
9. Maintenance and Service The XVISION-SPINE (XVS) system requires yearly maintenance. System calibration and updates are provided as required by service personnel. Service should only be provided by authorized Augmedics personnel. 9.1. Annual Headset Mechanical Maintenance On an annual basis verify the mechanical functionality of the HEADSET, paying special attention to the following elements.
Augmedics Ltd • xvision-Spine User Manual Version 7 If there are any problems with the mechanical functionality of the HEADSET contact Augmedics technical support. 9.2. Annual Headset Optical Maintenance The luminance of the HEADSET lens assembly may decrease due to aging. The purpose of this annual maintenance test is to verify that the luminance of the display is within predefined specifications.
10. Troubleshooting Message Area Warnings Problem or Message Result/Reason Solution No Navigation Display on Headset: MULTIPLE TOOLS The system has detected Remove the tool that is not in use.
Augmedics Ltd • xvision-Spine User Manual Version 7 Message Area Warnings (continued) Problem or Message Result/Reason Solution Versions mismatch detected in …" Software version mismatch detected Contact Service "Pairing failed” Communication problem Try again or Power off and on the Headset. If the problem persists, contact service.
10. Troubleshooting HEADSET Troubleshooting Problem or Message Result/Reason Solution HEADSET not turning on No power supply • Make sure that the battery cord is attached properly. • Make sure that the battery is inserted fully and that the indicator is full. HEADSET LED flashes light blue HEADSET is initializing Wait for flashing green. HEADSET LED flashes slow green HEADSET is connected to the XVISION-SPINEnetwork (router) but not paired to the Workstation Pair the HEADSET.
Appendix A: System Specifications The specifications listed apply to system operation under typical conditions: Environmental Conditions Operating Temperature Between 10 °C and 30 °C Electrical Safety Battery Specification Battery operated 9-12 V HEADSET Large Battery Pack Normal voltage 11.25V Battery capacity 6400 mAh Maximum charge current 4340 mA Discharge current 1200 mA HEADSET Small Battery Pack Normal voltage 11.
Appendix B: Waste Electrical and Electronic Equipment In accordance with Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE), any item which is marked with the crossed-out wheelie bin symbol must not be disposed of as unsorted municipal waste, but segregated from other waste types for eventual procedure and recovery at an approved recycling facility.
Appendix C: XVS Tool Adaptors The XVISION-SPINE system includes XVS adaptors that are suitable for most surgical instruments. Tool Name Diameter Swivel 7.5-9 mm Universal tool adaptor Leg Down 7.5 mm-9.0 mm Swivel 7.5-9.0 mm universal tool adapter Leg up 7.5 mm-9.0 mm Swivel 6-7.5mm universal tool adapter Leg up 6.0 mm-7.5 mm Swivel 6-7.5mm universal tool adapter Leg Down 6.0 mm-7.5 mm Swivel 5-6 mm universal tool adapter leg down 5.0 mm-6.0 mm Swivel 5-6 mm universal tool adapter leg up 5.
Appendix E: Setting up the Medtronic Oarm 2 Scanner Use the procedures below to set u the Medtronic O-arm 2 scanner. E.1: Connecting Ethernet Cable to XVISION-SPINE Plug one end of the Ethernet cable into the back of the O-arm 2 workstation (A) and connect the other end to any of the LAN ports 1 (1-4) (B) in the back of the XVISION-SPINE router. Note: Do not plug the Ethernet cable to the WAN port. E.2: Setting IP Address Use the procedure below to set the IP address.
Augmedics Ltd • xvision-Spine User Manual Version 7 1. Choose an existing study (A), select Saved Exams (B) and press Send To… (C) 2. 3. Press Navigation System (D) and Send Patient Images (E). Copy Stealth IP information (F) into the XVS SOFTWARE. See Configuring the Scanner Imaging Protocol on page 5-6 for more information. E.
Appendix E: Setting up the Medtronic O-arm 2 Scanner E.4: Sending Image to xvision-Spine 1. 2. Ensure all beads of the Z-Marker (A) and anatomy (B) are in both axial and lateral scout shots. Have the radiology tech make the following 3D settings prior to the 3D spin: • Always choose HD • Choose anatomy location • Choose patient size (only use Medium, Large or XL) • Choose patient positioning • Choose side O-arm in coming in from 3.
Augmedics Ltd • xvision-Spine User Manual Version 7 1. Choose the current patient (A), press Saved Exams (B) and then press Send To… (C). 2. Press Navigation System (D), Send Patient Images (E) and then press Send (F). Information is automatically sent to XVS SOFTWARE.
Appendix F: Setting up the Medtronic Oarm 1 Scanner Use the procedures below to set u the Medtronic O-arm 2 scanner. F.1: Connecting Ethernet Cable to XVISION-SPINE Plug one end of the Ethernet cable into the back of the O-arm 1 workstation (A) and connect the other end to any of the LAN ports 1 (1-4) (B) in the back of the XVISION-SPINE router. Note: Do not plug the Ethernet cable to the WAN port. F.2: Setting IP address Use the procedure below to set the IP address.
Augmedics Ltd • xvision-Spine User Manual Version 7 1. Choose an existing study (A), select Saved Exams (B) and press Send To… (C). 2. 3. Press DICOM Store Server or Navigation System (D) and Send Patient Images (E). Copy Stealth IP information (F) into the XVS SOFTWARE. See Configuring the Scanner Imaging Protocol on page 5-6 for more information. F.
Appendix F: Setting up the Medtronic O-arm 1 Scanner F.4: Sending Image to xvision-Spine 1. 2. Ensure all beads of the Z-Marker (A) and anatomy (B) are in both axial and lateral scout shots. Have the radiology tech make the following 3D settings prior to the 3D spin: • Always choose HD • Choose anatomy location • Choose patient size (only use Medium, Large or XL) • Choose patient positioning • Choose side O-arm in coming in from 3.
Augmedics Ltd • xvision-Spine User Manual Version 7 1. Choose the current patient (A), press Saved Exams (B) and then press Send To… (C). 2. Press Navigation System (D), Send Patient Images (E) and then press Send (F). Information is automatically sent to XVS SOFTWARE.
Appendix G: Setting up the Brainlab Airo Scanner Use the procedures below to set up the Brainlab Airo scanner. G.1: Connecting Ethernet Cable to XVISION-SPINE Plug one end of the Ethernet cable into left NAV port in the back of the Brainlab Airo workstation (A) and connect the other end to any of the LAN ports 1 (1-4) (B) in the back of the XVISION-SPINE router. Note: Do not plug the Ethernet cable to the WAN port. G.2: Setting IP Address Use the procedure below to set the IP address.
Augmedics Ltd • xvision-Spine User Manual Version 7 1. Choose an existing study (A) and press Next or Export (B). 2. Select the listed server (C) and then press Send to DICOM Node (D).
Appendix G: Setting up the Brainlab Airo Scanner G.3: Imaging Settings 3. When the image transfer fails (E) an error message displays the IP information (F). Copy the IP address into the XVS SOFTWARE. See Configuring the Scanner Imaging Protocol on page 5-6 for more information. G.3: Imaging Settings 1. Ensure that all beads of the ZLink and anatomy are in both axial and lateral scout shots. Note: 2. Because there is no monitor this is accomplished using hand control.
Augmedics Ltd • xvision-Spine User Manual Version 7 3. Scroll through the 3D axial image (A) and ensure that all 12 beads of the Z-Marker are in the image. G.4: Sending Image to xvision-Spine Information is sent automatically send to XVS SOFTWARE after the scan. Note: F-4 Archived studies cannot be sent.
Appendix H: Setting up the Ziehm RFD 3D Scanner Use the procedures below to set up the Ziehm RFD 3D scanner. H.1: Connecting Ethernet Cable to XVISION-SPINE Plug one end of the Ethernet cable back of the Ziehm monitor (A) and connect the other end to any of the LAN ports 1 (1-4) (B) in the back of the XVISION-SPINE router. Note: Do not plug the Ethernet cable to the WAN port. H.2: Setting IP address A trained Ziehm employee or distributor must be on site to set up the IP address. 1.
Augmedics Ltd • xvision-Spine User Manual Version 7 2. In the Ziehm console press Test (B). The Verification Successful window (C) indicates that the test has been completed. H.3: Imaging Settings Configure imaging setting as follows: 1. G-2 Ensure all beads of the Z-Marker (A) and anatomy (B) are in both axial and lateral scout shots.
Appendix H: Setting up the Ziehm RFD 3D Scanner H.4: Sending Image to xvision-Spine 2. Have the radiology tech make the following 3D settings prior to the 3D spin: • 3D (C) • Navigation Server: XVision (D) • Application: Bone (E) • Body Size: Adult (F) 3. • Body region: Spine (G) Follow the instructions and steps to perform a 3D scan. The scanner automatically sets the scan parameters based on patient information. Note: Patient’s breath must be held before the scan.
Appendix I: Setting up the Siemens Cios Spin Scanner Use the procedures below to set up the Cios Spin scanner. I.1: Connecting Ethernet Cable to XVISION-SPINE Plug one end of the Ethernet the side of the Cios Spin workstation (A) and connect the other end to any of the LAN ports 1 (1-4) (B) in the back of the XVISION-SPINE router. Note: Do not plug the Ethernet cable to the WAN port. I.2: Setting IP Address A Siemens representative must be on site to set up the IP address.
Augmedics Ltd • xvision-Spine User Manual Version 7 1. Choose Service tab (A) and the Man/Tool box icon (B). After the Siemens representative keys in the password press Configure (C). 2. Press DiICOM Node Settings (D) and then Create New (E).
Appendix I: Setting up the Siemens Cios Spin Scanner I.3: Imaging Settings 3. 4. Press Storage Mode (F) and then Standard (G) for 3D Volumes. Press Save (H). Copy the Cios Spin IP information into the XVS SOFTWARE. See Configuring the Scanner Imaging Protocol on page 5-6 for more information. I.3: Imaging Settings Configure imaging setting as follows: 1. Ensure all beads of the Z-Marker (A) and anatomy (B) are in both axial and lateral scout shots. 2.
Augmedics Ltd • xvision-Spine User Manual Version 7 3. Scroll through 3D axial image (E) and ensure that all 12 beads of the Z-Marker are visible. I.4: Sending Image to XVISION-SPINE After the scan is complete follow the procedure below.
Appendix I: Setting up the Siemens Cios Spin Scanner I.4: Sending Image to xvision-Spine 1. Choose 2D on workstation (A), select axial 3D image (B) and then Export (C). Note: 2. A selected image has a white highlight. A marked image has a checkmark. Set Target to XVISION (D), Transfer to Selected (E), and set this as default (F). The prest the Export icon (G). Information is automatically sent to XVS SOFTWARE.
Appendix J: All-In-One Computer User Manual TM-5010-24P/24F Medical Panel PC USER’S MANUAL V1.1 Copyright© ,2018. All rights reserved All other brand names are registered trademarks of their respective owners.
Augmedics Ltd • xvision-Spine User Manual Version 7 Version Change History Date Version Description 2018/9/20 1.0 First release Remove duplicate line p59 2018/11/05 1.
Appendix J: All-In-One Computer User Manual Acknowledgments Intel® 6th generation Core i and Celeron are registered trademarks of Intel® Corporation. IBM, PC/AT, PS/2 are trademarks of International Business Machines Corporation. ® Microsoft Windows is a registered trademark of Microsoft Corporation. ® RTL is a trademark of Realtek Semi-Conductor Co., Ltd. C&T is a trademark of Chips and Technologies, Inc. UMC is a trademark of United Microelectronics Corporation.
Augmedics Ltd • xvision-Spine User Manual Version 7 FCC Class B This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a residential environment. This equipment generates, uses and can radiate radio frequency energy.
Appendix J: All-In-One Computer User Manual Safety Instructions Intended use The TM-5010-24P/24F 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. It shall not be used for life-supporting system.
Augmedics Ltd • xvision-Spine User Manual Version 7 2. If the medical panel PC unit does fall to the ground, immediately turn the power off and disconnect cords. Then contact a service technician for repairs. Continual use of the unit may result cause a fire or electric shock. Also, do not repair the unit on your own. 3. Having two or more people transporting the display unit is recommended. In addition, when installing the unit by suspending it also requires two or more people. 4.
Appendix J: All-In-One Computer User Manual 8. Use your thumb and index finger, grip firmly on the power cord to disconnect from the electrical socket. By pulling the power cord, may result in damaging it. 9. If the unit is not going to be in use for an extended period of time, remember to disconnect the unit. 10. The medical panel PC unit uses voltage between 100-240VAC. Connect the unit to a power source with the same numerical value as shown.
Augmedics Ltd • xvision-Spine User Manual Version 7 2. Unless proper ventilation is present, do not place unit in an enclosed area; such as a built-in shelf. Keep a minimum distance of 10 cm between the display unit and wall. Operating principle A Medical Panel PC has four main components: the arithmetic logic unit (ALU), the control unit, the memory, and the input and output devices (collectively termed I/O). These parts are interconnected by buses, often made of groups of wires.
Appendix J: All-In-One Computer User Manual Error message / Troubleshooting No power 1. Connect the AC adapter to the computer, and then plug it into an AC outlet. 2. Turn on the computer. Servicing, Repairing, Maintenance & Safety Checks 1. If the unit is not functioning properly, observe the performance level of the display closely to determine what type of servicing is needed. 2. Do not attempt to repair the medical panel PC unit on your own.
Augmedics Ltd • xvision-Spine User Manual Version 7 ISO 7000-0434 : Caution, consult ACCOMPANYING DOCUMENTS. ISO 7000-1641 : Follow operating instructions or Consult instructions for use. IEC 60417 -5009 : STAND-BY. IEC 60417-5031 : Direct current. EU-wide legislation, as implemented in each Member State, requires that waste electrical and electronic products carrying the mark (left) must be disposed of separately from normal household waste.
Appendix J: All-In-One Computer User Manual When networking with electrical devices, the operator is responsible for ensuring that the resulting system meets the requirements set forth by the following standards: – EN 60601-1 (IEC 60601-1) Medical electrical equipment Part 1: General requirements for safety – EN 60601-1-1 (IEC 60601-1-1) Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for Medical electrical systems – EN 60601-1-2 (IEC 60601-1-
Augmedics Ltd • xvision-Spine User Manual Version 7 Caution: DO NOT LEAVE THIS EQUIPMENT IN AN UNCONTROLLED ENVIRONMENT WHERE THE STORAGE TEMPERATURE IS BELOW -20° C (-4° F) OR ABOVE 60° C (140° F). THIS MAY DAMAGE THE EQUIPMENT. This equipment shall not be used in life support systems. The user is not to touch SIP/SOPs and the patient at the same time. Caution – Use suitable mounting apparatus to avoid risk of injury.
