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Summary of Contents for fiagon Fiagon Navigation System
- Page 1 Instructions for Use Instructions for Use Fiagon Navigation System Copyright © 2018 Products DocumentID Version Date 1 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018...
- Page 2 Instructions for Use Product: Trade Name: Fiagon Navigation System Common Name of Device: Image guided surgery system Manufacturer Fiagon GmbH Neuendorfstraße 23b D -16761 Hennigsdorf Germany Telephone: +49 3302 20121 10 Fax: +49 3302 20121 15 info@fiagon.de Copyright © 2018...
- Page 3 The device must not be opened and repairing must only be done by qualified personal. Alternating current (AC) Protective earth (PE) Federal law (USA) restricts this device to sale by or on order of a physician. Copyright © 2018 Products DocumentID Version Date 3 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018...
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Page 4: Table Of Contents
Shutting down the system ........................... 23 Cleaning the surface of the device ......................24 Inspection instructions ..........................24 Maintenance ............................... 25 Routine checks............................25 Updates ..............................25 Copyright © 2018 Products DocumentID Version Date 4 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018... - Page 5 Conformity..............................27 Manufacturer ............................... 27 Technical data ............................. 28 Essential performance..........................28 Imaging systems ............................34 Monitors ..............................34 Medical video systems ..........................34 Copyright © 2018 Products DocumentID Version Date 5 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018...
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Page 6: Indented Use
The Fiagon Navigation System is a system that is used in surgical computer-assisted instrument navigation. Please refer to these instructions for use to operate the Fiagon system correctly and safely. You will find an overview and explanation of all relevant steps to set up the unit that are necessary for a navigated operation. -
Page 7: Contraindication
The navigation system may only be used with the components and accessories that the manufacturer indicates as suitable. The navigation system may only be used with Fiagon Navigation software and accessories that the manufacturer indicates as compatible with the system. -
Page 8: Description Of The Navigation Unit
Instructions for Use Description of the navigation unit 1. Navigation units (product code E 01 1103) with serial no. before 18-0700 Copyright © 2018 Products DocumentID Version Date 8 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018... - Page 9 Instructions for Use 2. Navigation units (product code E 01 1103) with serial no. starting from 18-0700 Copyright © 2018 Products DocumentID Version Date 9 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018...
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Page 10: Qualification Of The User
Patient data protection HIPAA Privacy Rule Compliance: Users of the Fiagon Navigation System have the option of assigning a password before system operation in order to prevent unauthorized access to individually identifiable health information. -
Page 11: Safety Notes In This Manual
Read these notes carefully. General safety notes All Fiagon products have been developed and manufactured in compliance with strict safety standards. Nevertheless, a 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 risks and safety phrases described in the instruction manual. -
Page 12: Safety Measures At The Installation Location
60601-1:2005 Clause 16 · Prior to each use, the system should be checked for loose components and damage. DO NOT use if these conditions exist. If service is required, contact your Fiagon Navigation sales representative immediately. · Use of an uninterrupted power supply (UPS) to the device is mandatory to ensure the device remains on during voltage dips and unintended interruptions for interventions that do not allow for delays in the procedure or absence of image guidance. -
Page 13: Electromagnetic Interference
Do not connect equipment other than storage media to the USB interface. The Network connection must be unplugged from the Fiagon Navigation System during surgery. Make sure Storage media are free of viruses before connecting to the system. - Page 14 RFID tags that will be in the measuring field. Consult the Instructions for use of the devices to check whether and where RFID technology is used. Copyright © 2018 Products DocumentID Version Date 14 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018...
- Page 15 The installation in the tower as well as the connection to the monitor and video source are subject to the initial installation. Consult the Fiagon service or your dealer. This procedure is done by Fiagon’s authorized personnel. WARNING: Use of an uninterrupted power supply (UPS) to the device is mandatory to ensure the device remains on during voltage dips and unintended interruptions for interventions that do not allow for additional delay in the procedure or absence of image guidance.
- Page 16 Cord -3 m A 21 9201 Hospital Grade (UL Approved according to UL 817) Warning: The cables and accessories provided by Fiagon should only be used in connection with the Fiagon navigation system. Copyright © 2018 Products DocumentID Version Date...
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Page 17: Preparation
NOTE: Use a head positioning cushion or ring on the navigation on headrest to support the head of the patient. Copyright © 2018 Products DocumentID Version Date 17 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018... -
Page 18: Starting The System
The Status indicators for the patient localizer and the Instrument will be displayed in black and white indicating that they are not connected. status indicator of patient localizer status indicator of instrument Copyright © 2018 Products DocumentID Version Date 18 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018... -
Page 19: Connecting The Patient Localizer With The System
Green indicator denotes instrument is in measurement field, Red indicator denotes instrument is outside measurement field or a distortion is detected Copyright © 2018 Products DocumentID Version Date 19 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018... - Page 20 NOTE: If the instrument or the localizer does not register at the navigation system, it cannot be used for the navigation. It needs to be exchanged. Copyright © 2018 Products DocumentID Version Date 20 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018...
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Page 21: Navigation Mode
The navigation instrument has the focus. Full screen 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 full screen on the display. The mode is activated when no navigation information is available for 3 seconds. - Page 22 You can export the documentation after the operation and save it on a CD-R, a DVD or a USB stick. NOTE: Further information to export the documentation are described in the instructions for use of the navigation software. Copyright © 2018 Products DocumentID Version Date 22 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018...
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Page 23: Disconnecting The Components
Troubleshooting – unintended power shut down Power shut down of Fiagon navigation system can occur by e.g. unintended removal of power plug, necessary change of the location of the device during surgery, power loss due to voltage dips (Dip>95% over 5s duration) or a power shut down due to electrical failures. -
Page 24: Cleaning The Surface Of The Device
Spilling liquids on any electrical device attached to the system should warrant inspection by an authorized Fiagon service technician. Inspection instructions After cleaning, visually inspect the system under good light conditions for remaining debris. Repeat cleaning procedures if required. -
Page 25: Maintenance
Updates of this instruction manual will be published as additional pages as soon as updated information or corrections are available. Updates will be provided along with a software update of the current version (e.g., update of Fiagon Navigation 3.6.5 to Fiagon Navigation 3.7.5). - Page 26 CAUTION: The navigation system must not be used without a valid instruction manual. The instruction manual corresponds to this new version. NOTE: For information on current hardware and software products, please visit the manufacturer's website: www.Fiagon.com Copyright © 2018 Products DocumentID Version Date 26 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018...
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Page 27: Conformity
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 us under the following address: Fiagon GmbH Neuendorfstraße 23b 16761 Hennigsdorf Germany... -
Page 28: Technical Data
Distortion detection method. Field distortions are detected. (95% confidence interval is < 2mm) total accuracy on anatomic preparation (mean value < 2 mm and < 2°) Copyright © 2018 Products DocumentID Version Date 28 / 34 Fiagon GmbH E 01 1103 DOC-18-00147 09-2018... - Page 29 Instructions for Use EMC compliance statement The Fiagon 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 system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
- Page 30 Instructions for Use Electromagnetic immunity The Fiagon system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment. Immunity Test IEC 60601-1-2 Test...
- Page 31 Instructions for Use Electromagnetic immunity The Fiagon system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment. Immunity Test IEC 60601-1-2 Test...
- Page 32 Recommended separation distances between portable and mobile RF communications equipment and the Fiagon system The Fiagon system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Fiagon system can help prevent...
- Page 33 Instructions for Use The Fiagon navigation should only be connected with the following accessories and cables to comply with the standards mentioned above. Interface Type Cable Type / Max. length Fiagon Order No. Remarks accessory Monitor Out/ DVI – D, shielded...
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Page 34: Imaging Systems
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.
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