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Instructions for Use

Copyright © 2020

DocumentID

Version

Date

1 / 33

Fiagon GmbH

DOC-19-00169 2

08-2020

EN / US

Instructions for Use

Fiagon Cube Navigation System

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Summary of Contents for E 01 1106-4K/8

Page 1: ...1 Instructions for Use Copyright 2020 DocumentID Version Date 1 33 Fiagon GmbH DOC 19 00169 2 08 2020 EN US Instructions for Use Fiagon Cube Navigation System ...

Page 2: ...ation 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 Component Model Navigation Unit Cube4D E 01 1106 HD 8 HD 8 sensor channels E 01 1106 4K 8 4K 8 sensor channels E 01 1106 HD 4 HD 4 sensor channels ...

Page 3: ...3 Instructions for Use Copyright 2020 DocumentID Version Date 3 33 Fiagon GmbH DOC 19 00169 2 08 2020 EN US Content ...

Page 4: ...4 Instructions for Use Copyright 2020 DocumentID Version Date 4 33 Fiagon GmbH DOC 19 00169 2 08 2020 EN US ...

Page 5: ...tation Recommended storage temperature 15 C to 35 C Applied part type BF This is the general warning sign It is used to alert the user to potential hazards All safety messages that follow this sign shall be obeyed to avoid possible harm The device is delivered non sterile Devices that include RF transmitters or that apply RF electromagnetic energy for diagnosis or treatment Portable and mobile RF ...

Page 6: ...onment The Fiagon Cube Navigation Systemm is designed to operate in Professional Healthcare Environment 1 2 Indications for use The Fiagon Cube Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model of the anatomy Specific indication...

Page 7: ...thorized installation of software and modifications or alterations of the device are not permitted due to safety reasons Do not use the system if medical or clinical reasons contraindicate its use 1 4 Description of the Fiagon Cube Navigation System The navigation system allows the tracking and navigation of surgical instruments during surgical procedures using stereotactic techniques The location...

Page 8: ...ube4D models The Navigation Unit Cube4D is available in three models which differ in Video input HD or 4K and amount of sensor channel 4 or 8 The following table gives an overview of the models Model reference Video In specifications Sensor Channel specifications E 01 1106 HD 8 Digital Video Input up to HD 1080p up to 60Hz Analog Video Input PAL or NTSC 8 sensor channels available for connection o...

Page 9: ...ensor port Multi chanel port for Patient Localizer Instruments via VirtuLink extension for models HD 8 and 4k 8 direct or via double instrument support for model HD 4 On Off button Status indicator for instruments Mains connector LAN1 PACS WiFi Antenna Mains switch Monitor Control LAN 2 Monitor Out HDMI Digital Video In DVI Monitor Out DVI Protective earth Analog Video In Composite USB port 4x 4K ...

Page 10: ...al procedures CAUTION Do not use the Navigation System if medical or clinical reasons contraindicate its use CAUTION Do not use the Navigation System if you have not received appropriate training for the safe and efficient use of the Navigation System 1 6 Patient Data Protection HIPAA Privacy Rule Compliance Users of the Fiagon Navigation System have the option of assigning a password before syste...

Page 11: ...ables must be routinely checked and replaced if damaged DANGER Only use the Navigation System in rooms that comply with applicable laws and regulations regarding the safety of electrical systems DANGER The Navigation System must not be used in the presence of combustible gases and vapors The use of electrical devices in surroundings that are not intended for such use may lead to fire and explosion...

Page 12: ...gnal input port or signal output port a medical electrical system is configured It has to be ensured that the Navigation System complies with the requirements of the Navigation System standard 60601 1 ed 3 1 Clause 16 Prior to each use the user must check the functionality and the proper condition of the Navigation System check for loose components and damage DO NOT use the Navigation System if th...

Page 13: ...rs 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 If interference occurs the navigation data are not displayed because they may be inaccurate Once the source of interferenc...

Page 14: ...t is made of touchable conductible parts metal etc and is categorized as protection class 1 and having touchable conductible housing parts the part is required to be provided with an additional potential equalization and to be included in the overall potential equalization Connect this pin to the central potential equalization pin of the endoscopy tower or the room The additional potential equaliz...

Page 15: ...ackside USB Mouse USB Service keyboard 2 m A 00 9101 A 00 9102 port Extension cable instrument instrument or patient localizer 2 m A 00 1200 all Fiagon navigation instruments all C Type Localizer can be connected Multi channel port Cube VirtuLink for up to 3 instruments or patient localizer 2 m E 01 1136 For models with 8 sensor channel HD 8 and 4K 8 all Fiagon navigation instruments all C Type Lo...

Page 16: ...The main switch of the Navigation Unit Cube4D is located on the backside It should be switched to On If the system does not start check the position of the main switch 3 Push the main switch of the system tower on the backside of the module 4 Attach a headrest with the Navigation Sensor to the operating table Place the shaft of the headrest into the appropriate holding fixture of the operating tab...

Page 17: ...on on the front panel of the unit You will hear a confirmation tone after the Navigation Software has started 4 3 Overview of the connections Navigation Sensor e g in headrest Cable connection between Cube and Monitor optional endoscope microscope Optional Automatic Wireless Connection to iPad Remote Control Patient Localizer Instrument connector Patient Localizer Instrument connector Cube VirtuLi...

Page 18: ...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 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 Insert the plu...

Page 19: ...epted and registered to the Navigation System 4 6 Connecting the applied part navigated instrument with the system Take the instrument out of the sterile pouch and place it on the instrument table Insert the plug of the instrument into the appropriate green socket on the Navigation Unit Cube4D Cube VirtuLink Note that the white marking at the Navigation Unit Cube4D plug is at 12 o clock position C...

Page 20: ...tes instrument is outside the measurement field or distortion is detected NOTE Before using the navigation the patient registration has to be done according to the description of the application Consult the instructions for use of the software and respective navigation application NOTE If the instrument or the localizer does not register at the Navigation System it cannot be used for navigation an...

Page 21: ...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 That is when the navigation instrument is currently not used and is guided out of the measurement field of the navigation sensor The status indicator is red The user automatically gets the available video information in an optimized fulls...

Page 22: ...threshold reached or localizer out of the electromagnetic field Solid orange System start System powered on and booting up Software starting Software in Mouse Mode Field generator is connected and turned off Default state if software does not start or if the software is closed Solid red Issue detected Broken instrument or localizer is detected in Mouse Mode or Navigation Mode Instrument with 0 use...

Page 23: ...screenshots have been taken you will hear a confirmation tone To record a video sequence press the button v on the keyboard You will hear a confirmation tone The video recording will be displayed by a green camera symbol in the status bar To stop the recording press the button v on the keyboard once more You can export the documentation after the operation and save it on a USB stick NOTE Further i...

Page 24: ...r the kink protection This might damage the cable Disconnect the navigation sensor from the navigation unit as well 7 2 Shutting down the system After the operation you can shut down the system by pressing the ON OFF button on the Navigation Unit Cube4D The system will shut down automatically Once the shut down has been completed you can pull the plug of the device tower Do not pull the cable or t...

Page 25: ...llows wiping disinfection Apply the solution onto a soft cloth and wipe the entire surface of the housing Wait until the solution has dried off before switching on the Navigation Unit Cube4D For cleaning the components and accessories headrest surgical instruments and the localizer refer to the cleaning recommendations included in the corresponding instructions for use 9 2 Inspection Instructions ...

Page 26: ...ry maintenance work has been carried out before using the Navigation System on a patient DANGER The Navigation System must not be operated if maintenance activities and checks are not regularly carried out in compliance with the requirements and guidelines of applicable laws WARNING Maintenance work may only be carried out by qualified and authorized personnel CAUTION Make sure that all necessary ...

Page 27: ...in your country to get the valid instructions needed for disposal of these components in compliance with the standards applying Technical description 12 1 Conformity The Navigation System was found to be in compliance with the European Medical device directive and has been affixed with the CE marking Therefore it is compliant with the following directive MDD 93 42 EEC 12 2 Manufacturer The manufac...

Page 28: ... C Humidity 30 to 75 without condensation Air pressure 700 hPa to 1060 hPa Transport conditions Temperature 10 C to 35 C Humidity 30 to 75 without condensation Air pressure 700 hPa to 1060 hPa Storage conditions Protected against dust and moisture Recommended storage temperature 15 to 35 C Recommended storage humidity 30 to 75 without condensation Recommended storage air pressure 700 hPa to 1060 h...

Page 29: ...nment Emission Test Compliance Electromagnetic Environment Guidance RF emissions following IEC CISPR 11 Group 1 The Fiagon Cube Navigation System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions following IEC CISPR 11 Class B The Fiagon Cube Navigation System is suitable fo...

Page 30: ... 15 kV ad 2 kV mains 1 kV I O 1 kV dm 2 kV cm Reduction to 0 UT for 0 5 cycles 0 UT for 1 cycle 70 UT for 25 cycles 50Hz 30 cycles 60Hz 0 UT for 250 cycles 50Hz 300 cycles 60Hz 3 A m Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typ...

Page 31: ...ed separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with this symbol a Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateu...

Page 32: ...ve the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations E...

Page 33: ...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 Warning Only connect items devices that have been specified as part of the Fiagon Cube Navigation System or specified as being compatible with the Fiagon Cube Navigation System Monitors The navigation mo...

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