fiagon Navigation Unit Cube 4D Instructions For Use Manual

Image-guided surgery system

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Instructions for Use

Fiagon GmbH

Instructions for Use

Fiagon Cube Navigation System

DocumentID

Version

DOC-19-00169

Date

1 / 33

08-2020

EN / US

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Summary of Contents for fiagon Navigation Unit Cube 4D

Page 2 Instructions for Use Product: Trade Name: Fiagon Cube Navigation System Common Name of Device: Image-guided surgery system Manufacturer Fiagon GmbH Component/ Model Neuendorfstraße 23b Navigation Unit Cube D -16761 Hennigsdorf Germany E 01 1106-HD/8 (HD, 8 sensor channels) E 01 1106-4K/8 (4K, 8 sensor channels)
Page 5 Alternating current (AC) Protective earth (PE) Federal law (USA) restricts this device to sale by or on the order of a physician. Consult instructions for use Copyright © 2020 DocumentID Version Date 5 / 33 Fiagon GmbH DOC-19-00169 08-2020 EN / US...
Page 6 CAUTION: This system is intended for use by healthcare professionals only. 1.1. Intended use The Fiagon Cube Navigation System and its components are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device is a positioning aid/display for surgical instruments. Surgeons use this system as a tool to locate anatomical structures in the patient during an operation.
Page 7 (image based and model based). Refer to the instructions for use of the software and the Fiagon Application Notes of the procedures for guidance on the selection of a suitable localizer, headrest, and instrument type for each procedure.
Page 8 Digital Video Input up to HD 1080p 4 sensor channels available for Analog Video Input PAL or NTSC connection of up to 2 Instuments Copyright © 2020 DocumentID Version Date 8 / 33 Fiagon GmbH DOC-19-00169 08-2020 EN / US...
Page 9 Monitor Out Protective Analog Digital USB port HDMI earth Video In Video In (4x) Video In (Composite) (DVI) (4xSDI) Models Model -HD/8 and -HD/4 -4K/8 Copyright © 2020 DocumentID Version Date 9 / 33 Fiagon GmbH DOC-19-00169 08-2020 EN / US...
Page 10 Navigation System. 1.7. Cyber and information security Fiagon strongly recommends to use anti-virus software and to keep the firewall settings of the Operating system (Windows 10 professional) active (delivery settings). We recommend the use of the software Avira Antivirus Premium 2013 (Avira Operations GmbH &...
Page 11 Read these notes carefully. 2.2. General safety notes All Fiagon products have been developed and manufactured in compliance with strict safety standards. Nevertheless, proper use and regular maintenance of the medical system is required. It is indispensable that the users of this system carefully read and pay attention to all risk and safety phrases described in the instruction manual.
Page 12 Before connecting the Navigation System to network or data coupling, identify, analyze, evaluate, and control the resulting risk. WARNING: Do not connect devices other than storage media or Fiagon approved devices to the USB interface. CAUTION: The Network connection must be unplugged from the Fiagon Navigation System during surgery.
Page 13 In case interference occurs contact Fiagon Service. If EM disturbances occur: The Fiagon Cube Navigation System has an automatic interference detection that shows the user when interference occurs during navigation. Standard instruments such as endoscopes or forceps normally do not cause any interference.
Page 14 The installation in the OR, the tower as well as the connection to the monitor and video source are subject to the initial installation. Consult the Fiagon service or refer to the guide “bringing into service after transport”. Medical Monitor...
Page 15 Hospital Grade (UL Approved according to UL 817) WARNING: The cables and accessories provided by Fiagon should only be used in connection with the Navigation Unit Cube . Other than those specified may result in increased emissions or decreased immunity of the Navigation Unit Cube Copyright ©...
Page 16 Refer to the instructions for use of the specific Navigation headrest type for detailed mounting instructions. NOTE: Use a head positioning cushion or ring on the headrest to support the head of the patient. Copyright © 2020 DocumentID Version Date 16 / 33 Fiagon GmbH DOC-19-00169 08-2020 EN / US...
Page 17 Connection to iPad endoscope/microscope Remote Control Patient Localizer/ Instrument connector Cube VirtuLink Navigation Sensor Multiport extention cable (e.g. in headrest) Patient Localizer/ Instrument connector Copyright © 2020 DocumentID Version Date 17 / 33 Fiagon GmbH DOC-19-00169 08-2020 EN / US...
Page 18 Cube. Note that the red marking at the plug is at 12 o'clock position. This socket is suitable to connect to all Fiagon Navigation Sensors. Once the Navigation Sensor is connected, you will hear a confirmation tone and the status bar will appear on the top of the navigation screen.
Page 19 12 o'clock position. CAUTION: Note that you are inserting the plug of the instrument into a non-sterile device. This socket is suitable to connect to all Fiagon Instruments (applied parts), which can be identified by their green marked plug.
Page 20 NOTE: If the instrument or the localizer does not register at the Navigation System, it cannot be used for navigation and needs to be exchanged. Copyright © 2020 DocumentID Version Date 20 / 33 Fiagon GmbH DOC-19-00169 08-2020 EN / US...
Page 21 The navigation instrument has the focus. 5.2. Fullscreen video mode This mode is configured in the applications (modules) offered by Fiagon that utilize a video signal of a medical video device (endoscope or microscope). In this mode, the connected video signal is displayed in fullscreen on the display. The mode is activated when no navigation information is available for 3 seconds.
Page 22 Instructions for Use 5.4. LED feedback The Fiagon Cube Navigation System gives the user real-time feedback about its status and the status of connected instruments and localizers via the LED feedback bar of the Navigation Unit Cube The following table states the status of different lighting:...
Page 23 You can export the documentation after the operation and save it on a USB stick. USB ports NOTE: Further information to export the documentation is described in the instructions for use of the navigation software. Copyright © 2020 DocumentID Version Date 23 / 33 Fiagon GmbH DOC-19-00169 08-2020 EN / US...
Page 24 Do not pull the cable or the kink protection. This might damage the cable. to “Off Position” à O at the back. Turn the main switch of the Navigation Unit Cube Copyright © 2020 DocumentID Version Date 24 / 33 Fiagon GmbH DOC-19-00169 08-2020 EN / US...
Page 25 Spilling liquids on any electrical device attached to the system should warrant inspection by an authorized Fiagon service representative. 9.2. Inspection Instructions After cleaning, visually inspect the system under appropriate light conditions for remaining debris.
Page 26 CAUTION: Make sure that all necessary safety measures are taken into account during maintenance work to prevent damage and injuries. NOTE: Fiagon recommends keeping a medical devices book for the repair and maintenance work carried out. Take notes of relevant information regarding the type of work, the company that carried out the work, and other important information.
Page 27 MDD 93/42/EEC 12.2. Manufacturer The manufacturer acts in compliance with international and national standards and laws. Information about the compliance can be provided on request. Please contact your regional consultant or contact Fiagon using the following contact details : Fiagon GmbH...
Page 28 The device is not designed for use with or near inflammable or explosive gases. The Fiagon Cube Navigation System WiFi works in the 2,4 GHz frequency band according to the standards 802.11 ac/a/b/g/n with a transmission power of 100 mW maximum.
Page 29 Instructions for Use EMC compliance statement The Fiagon Cube Navigation System needs special precautions regarding EMC and needs to be installed and put into service according to the following described EMC information. Electromagnetic emission The Fiagon Cube Navigation System is intended for use in the electromagnetic environment specified below.
Page 30 Electromagnetic immunity The Fiagon Cube Navigation System is intended for use in the electromagnetic environment specified below. The customer or the user of the Fiagon Cube Navigation System should assure that it is used in such an environment. Immunity Test...
Page 31 Instructions for Use Electromagnetic immunity The Fiagon Cube Navigation System is intended for use in the electromagnetic environment specified below. The customer or the user of the Fiagon Cube Navigation System should assure that it is used in such an environment. Immunity...
Page 32 The Fiagon Cube Navigation System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Fiagon Cube Navigation System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Fiagon Cube Navigation System as recommended below, according to the maximum output power of the communications equipment.
Page 33 Contact a service representative if you plan to use a different device. Before using the Fiagon system for the first time in clinical routine, it is necessary to check its compatibility with the CT scanner or DVT. If problems arise regarding the loading process of image data sets, please contact your service representative.

This manual is also suitable for:

E 01 1106-hd/8 E 01 1106-4k/8 E 01 1106-hd/4