Augmedics XVISION-SPINE User Manual

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XVISION

PINE

User Manual

Augmedics Ltd

1 Ha-Tsmikha St., Yoqneam Illit 2069205, Israel

1-888-814-4988

Version 7

https://augmedics.com/

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Summary of Contents for Augmedics XVISION-SPINE

Page 1 XVISION PINE User Manual Augmedics Ltd 1 Ha-Tsmikha St., Yoqneam Illit 2069205, Israel 1-888-814-4988 Version 7 https://augmedics.com/...
Page 3 License Contract design is the exclusive property of Augmedics Ltd. Any copying either in part or XVISION PINE in whole is strictly prohibited.
Page 5: Table Of Contents
2.7. Method of Sterilization or Disinfection 2-10 2.8. Manufacturer Responsibility 2-10 2.9. General Notes, Cautions, and Warnings 2-10 3. Overview 3.1. Intended Use 3.2. Intended User and Environment 3.3. Contraindications 4. xvision-Spine Components 4.1. XVS Software 4.2. Router 4.3. Headset 4.4. Battery and Charger...
Page 6 4.7. Single Use Sterile Kit 4.8. Optional Accessories 4.8.1. Roll Stand 4.8.2. All-In-One Computer 4.8.3. Tablet Computer 5. xvision-Spine System Installation and First Use 5.1. XVS Software Installation 5.1.1. XVS Software Installation Procedure 5.1.2. Hospital-Supplied Computer Requirements 5.2. Accessory Assembly Instructions 5.3.
Page 7 Appendix B: Waste Electrical and Electronic Equipment Appendix C: XVS Tool Adaptors Appendix D: XVS Patient Clamps Appendix E: Setting up the Medtronic O-arm 2 Scanner E.1: Connecting Ethernet Cable to xvision-Spine E.2: Setting IP Address E.3: Imaging Settings E.4: Sending Image to xvision-Spine Appendix F: Setting up the Medtronic O-arm 1 Scanner F.1: Connecting Ethernet Cable to xvision-Spine...
Page 8 Augmedics Ltd • xvision-Spine User Manual Version 7 G.4: Sending Image to xvision-Spine Appendix H: Setting up the Ziehm RFD 3D Scanner H.1: Connecting Ethernet Cable to xvision-Spine H.2: Setting IP address H.3: Imaging Settings H.4: Sending Image to xvision-Spine Appendix I: Setting up the Siemens Cios Spin Scanner I.1: Connecting Ethernet Cable to xvision-Spine...
Page 9: Introduction
Note: This product and/or the use of this product in a method may be covered by one or more patents or patent applications, available at https://augmedics.com/patents/. 1.2. Conventions Used in this Manual Throughout this manual, cautions and warnings are used to provide critical information needed before the device is used.
Page 10: List Of Symbols
Augmedics Ltd • xvision-Spine User Manual Version 7 1.3. List of Symbols The following symbols may appear on system equipment, system packaging or in this manual: Symbol Meaning Consult operating instructions Manufacturer Date of manufacture Use by: the date after which the device shall not be used...
Page 11: Safety Information
Setup and training of the XVS system is provided by Augmedics Ltd. Do not operate the XVS system before reading this manual and gaining a clear understanding of the operation of the system. If any part of this manual is not clear, contact your Augmedics representative for clarification.
Page 12: Electromagnetic Compatibility
Otherwise, degradation of the performance of this equipment could result. Caution: Any changes or modifications not expressly approved by Augmedics Ltd could void the user’s authority to operate the equipment. 2.4.1. FCC Class A This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference than may cause undesired operation.
Page 13: Cybersecurity User Instructions
System OFTWARE Communication (page 5-3). Augmedics recommends that users enable a firewall on the hospital PC and configure the firewall so that only the network is enabled. XVISION PINE Augmedics Ltd uses industry-standard instructions to protect the system.
Page 14: Reporting Device Security Or Privacy Breaches
Augmedics recommends that users configure their PC to update automatically, to ensure that cybersecurity and other security updates are applied to the PC as soon as they become available. For a pre-configured Augmedics PC, the updates will be part of the annual maintenance procedure.
Page 15: Software Maintenance Support For The Software
2. Safety Information 2.6. Electromagnetic Immunity Declaration Software Maintenance Support for the Software Any software updates and patches are handled in a similar way to the basic installation. After the update is developed and verified and new software installation is created this is supplied to the service technician who will need to visit the customer and install the update.
Page 16 Augmedics Ltd • xvision-Spine User Manual Version 7 Declaration: Electromagnetic Immunity (Headset) (continued) Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance Radiated RF IEC 3V/m 3V/m Portable and mobile RF communications 61000-4-3 equipment should be used no closer to any part...
Page 17: Optional Tablet And Router
2. Safety Information 2.6. Electromagnetic Immunity Declaration Optional T and Router ABLET Declaration: Electromagnetic Emissions (Optional Tablet and Router) Emissions Test Compliance Electromagnetic Environment – Guidance RF emissions CISPR 11 Group1 Class A The XVS system and the Tablet use RF energy only for its internal function.
Page 18 Augmedics Ltd • xvision-Spine User Manual Version 7 Declaration: Electromagnetic Immunity (Optional Tablet and Router) (continued) Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance Conducted RF 3V, 6V 3Vrms, 6V Portable and mobile RF communications IEC 61000-4-6...
Page 19 2. Safety Information 2.6. Electromagnetic Immunity Declaration Recommended Separation Distances (Headset and Optional Tablet) Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the XVS System Rated Maximum Separation Distance According to Frequency of Transmitter (m) Output Power of 150 kHz to 80 MHz 150 kHz to 80 MHz in 80 MHz to 800 MHz...
Page 20: Method Of Sterilization Or Disinfection
The other parts of the XVS system should not be sterilized. 2.8. Manufacturer Responsibility Augmedics Ltd is responsible for the safety, reliability and performance of the XVS system only if: • Assembly, operations, extensions, modifications, service and repairs are carried out by authorized Augmedics personnel •...
Page 21 PINE Caution: For continued protection against the risk of fire, use only system cables and accessories approved or supplied by Augmedics. Other cables and accessories may damage the system or interfere with its safe operation. Caution: Do not touch the H...
Page 23: Overview
3. Overview (XVS) system is a stereotactic image-guided navigation system designed to XVISION PINE assist surgeons in placing pedicle screws accurately, during open or percutaneous computer- assisted spinal surgery. The system is designed to provide surgeons with an immersive 3D and 2D visualization of patient’s anatomy through skin and tissue.
Page 24: Contraindications
Augmedics Ltd • xvision-Spine User Manual Version 7 3.3. Contraindications Medical conditions which contraindicate the use of the XVS system include any medical conditions which may contraindicate the medical procedure itself.
Page 25: Xvs Software
Components XVISION PINE (XVS) system is comprised of the following main components. XVISION PINE 4.1. XVS Software The dedicated XVS S receives the intraoperative 3D scanner images and calculates OFTWARE the registration between the patient’s anatomy and the acquired intraoperative images. It also creates a 3D scanned spine model and initializes the H EADSET It then receives tracking information calculated by the infrared (IR) H...
Page 26 Augmedics Ltd • xvision-Spine User Manual Version 7 Figure 1: H ID of Parts EADSET Head light On/Off switch Head strap adjustment knob Battery connector Large rechargeable battery Small rechargeable battery (option) Rechargeable battery holder WiFi antennas pads EADSET Folding lock mechanism...
Page 27: Battery And Charger
Pull the battery out of the battery case. Set the battery into its charger stand. Recharge the battery after every surgical procedure. The full charge cycle takes between one to two hours. Note: When the battery reaches 30 life cycles, contact Augmedics Ltd.
Page 28 Augmedics Ltd • xvision-Spine User Manual Version 7 4.5. Footswitch XVISION PINE Footswitch (FCC-ID: 2AODW-NRF24L01SMD) enables wireless control of XVISION PINE by the surgeon XVS S functions. See Footswitch Controls on page 7-9 XVISION PINE OFTWARE for more information. Note: Footswitch is powered by four AAA batteries.
Page 29 4. xvision-Spine Components 4.6. Reusable Components Figure 4: XVS Instrument Tray for Universal Tools (Maximal Configuration) XVS Instrument Tray for Universal Tools (ASP00027) XVS Arc Clamp (AMCH00006) XVS Short Straight Clamp (62 mm) (AMCH00005) XVS Wrench (AMCH00030) Screwdriver 4 mm (SCDH00004) Fixed 3-4 mm universal tool adaptor Leg Up (AMCFSU03) Swivel 7.5-9 mm universal tool adaptor Leg Down (AMCRMD75)
Page 30 Augmedics Ltd • xvision-Spine User Manual Version 7 Figure 5: XVS Instrument Tray for Navigated Tools (Maximal Configuration) XVS Instrument Tray for Navigated Tools (ASP00011) XVS Arc Clamp (AMCH00006) XVS Short Straight Clamp (62 mm) (AMCH00005) XVS Wrench (AMCH00030) Screwdriver 4 mm (SCDH00004)
Page 31 4. xvision-Spine Components 4.8. Optional Accessories Warning: Do not use the sterile components if the expiration date has passed. Warning: The sterile components are intended for use during a single procedure only. Discard after use. Do not re-sterilize. If the package is found opened or damaged, discard these components and use components from a new package.