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Instructions for Use

Copyright © 

2018  Products

DocumentID

Version

Date

4 / 34

Fiagon GmbH

E 01 1103

DOC-18-00147 1

09-2018

Indented use ................................................................................................................................................. 6

Indications for use ......................................................................................................................................... 6

Contraindication ............................................................................................................................................ 7

Description of the navigation unit .................................................................................................................. 8

Qualification of  the user ............................................................................................................................... 10

Patient data protection ................................................................................................................................ 10

Cyber and information security .................................................................................................................... 10

Safety notes in this manual ......................................................................................................................... 11

General safety notes ................................................................................................................................... 11

Safety measures at the installation location ................................................................................................. 12

Safety measures when using the system .................................................................................................... 12

Electromagnetic  interference ....................................................................................................................... 13

Electromagnetic navigation ......................................................................................................................... 13

Preparation ................................................................................................................................................. 17

Starting the system ..................................................................................................................................... 18

Overview of the connections ....................................................................................................................... 18

Connecting the navigation sensor with the system ...................................................................................... 18

Connecting the patient localizer with the system ......................................................................................... 19

Connecting the navigated instrument/ mapping device with the system ...................................................... 19

Navigation mode ......................................................................................................................................... 21

Full screen Video mode ............................................................................................................................... 21

Mouse mode ............................................................................................................................................... 21

Disconnecting the components ................................................................................................................... 23

Shutting down the system ........................................................................................................................... 23

Cleaning the surface of the device .............................................................................................................. 24

Inspection  instructions ................................................................................................................................. 24

Maintenance ............................................................................................................................................... 25

Routine checks............................................................................................................................................ 25

Updates ...................................................................................................................................................... 25

Summary of Contents for Fiagon Navigation System

Page 1: ...1 Instructions for Use Copyright 2018 Products DocumentID Version Date 1 34 Fiagon GmbH E 01 1103 DOC 18 00147 1 09 2018 Instructions for Use Fiagon Navigation System ...

Page 2: ...4 Fiagon GmbH E 01 1103 DOC 18 00147 1 09 2018 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 ...

Page 3: ...entation Recommended storage temperature 15 C to 35 C Applied part type B 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 4: ...ation location 12 Safety measures when using the system 12 Electromagnetic interference 13 Electromagnetic navigation 13 Preparation 17 Starting the system 18 Overview of the connections 18 Connecting the navigation sensor with the system 18 Connecting the patient localizer with the system 19 Connecting the navigated instrument mapping device with the system 19 Navigation mode 21 Full screen Video...

Page 5: ...opyright 2018 Products DocumentID Version Date 5 34 Fiagon GmbH E 01 1103 DOC 18 00147 1 09 2018 Conformity 27 Manufacturer 27 Technical data 28 Essential performance 28 Imaging systems 34 Monitors 34 Medical video systems 34 ...

Page 6: ...escribed in this instruction manual Read the instructions for use carefully before using the instrument Keep the instruction manual close to the device so you can use it at any time CAUTION U S Federal law restricts this device to sale by or on the order of a physician Indented use This system is intended for use by healthcare professionals only The Fiagon Navigation System is intended as an aid f...

Page 7: ...ronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators e g deep brain stimulation programmable CSF shunts The system must not be used at patients with monopolar pacemakers older designs with lower resistance to interference or ICD s implantable cardioverter defibrillator The system should not be used in patients with implantable body worn devices...

Page 8: ...s for Use Copyright 2018 Products DocumentID Version Date 8 34 Fiagon GmbH E 01 1103 DOC 18 00147 1 09 2018 Description of the navigation unit 1 Navigation units product code E 01 1103 with serial no before 18 0700 ...

Page 9: ...9 Instructions for Use Copyright 2018 Products DocumentID Version Date 9 34 Fiagon GmbH E 01 1103 DOC 18 00147 1 09 2018 2 Navigation units product code E 01 1103 with serial no starting from 18 0700 ...

Page 10: ...d the clinical procedures CAUTION Do not use the system if medical or clinical reasons contraindicate its use CAUTION Do not use the system if you have not received an appropriate training for the safe and efficient use of the system 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 t...

Page 11: ...sed with power networks that meet the described requirements The plugs and cables must be routinely checked and replaced if damaged DANGER Only use the system in rooms that are in compliance with applicable laws and regulations regarding the safety of electrical systems DANGER The system must not be used in the presence of combustible gases and vapors The use of electrical devices in surroundings ...

Page 12: ...irements of the system standard 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 interru...

Page 13: ...p 95 over 5s duration from the mains supply may lead to a power loss of the unit The unit and navigation software will restart automatically on return of the voltage to nominal level After approx 40 seconds the unit is back to operation The registration of the patient will be restored on reloading the patient Please refer to section Troubleshooting unintended power shut down for details for mitiga...

Page 14: ...ry systems with EM tracking technology In adjacent rooms MR scanner For EMC technical specifications of the system refer to the related chapter in this document NOTE RFID tags are not likely to interfere with the system unless they are positioned directly between the field generating device and the sensor Make sure the instruments and equipment used for the surgery do not contain any RFID tags tha...

Page 15: ...emarks Monitor Out DVI IN DVI D shielded 2 m A 00 9201 Video In Composite Video shielded 2 m A 00 9202 Monitor Control RS 232 2 m A 00 9204 USB backside USB Mouse 2 m A 00 9101 Instrument Double instrument support 2 m A 01 1203 Instrument Extension cable instrument 2 m A 00 1200 Patient localizer Extension cable localizer 2 m A 001201 USB frontside for pen drives Not to be used in navigation mode ...

Page 16: ...01 1103 DOC 18 00147 1 09 2018 Mains connector Mains power cord UL Approved 1 80 m A 21 9200 Power Supply Cord Hospital Grade UL Approved according to UL 817 3 m A 21 9201 Warning The cables and accessories provided by Fiagon should only be used in connection with the Fiagon navigation system ...

Page 17: ... located on the back It should be switched to On If the system does not start check the position of the main switch 3 Mount navigation sensor Attach a head rest with the navigation sensor to the operating table Place the shaft of the head rest into the appropriate holding fixture of the operating table and lock the head rest Type navigation headrest Maquet Type navigation headrestFlat Refer to the...

Page 18: ...ensor with the system Insert the plug of the navigation sensor e g Navigation Headrest Maquet into the appropriate socket sensor metal socket on the navigation module Note that the red marking at the plug is at 12 o clock position 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 th...

Page 19: ...ce with the system Take the instrument or mapping device out of the sterile pouch and place it on the instrument table Insert the plug of the component into the appropriate socket Instrument green socket on the navigation module Note that the white marking at the plug is at 12 o clock position CAUTION Note that you are inserting the plug of the component into a non sterile device Once the navigate...

Page 20: ...g the navigation the patient registration has to be done accordingly to the description of the application Consult the instructions for use of the software and navigation application respectively 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 ...

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

Page 22: ...shot has been taken you will hear a confirmation tone To record a video sequence press the video button on the navigation module You will hear a confirmation tone The video recording will be displayed by a green camera symbol in the status bar and a highlighted video button To stop the recording press the video button once more You can export the documentation after the operation and save it on a ...

Page 23: ...Dip 95 over 5s duration or a power shut down due to electrical failures Under these circumstances the computer screen is blank and does not show the intra operative images Also the green power indicator LED light on the navigation unit is turned off The system starts automatically immediately after the power returns It takes 40s till the navigation software is ready for the user to interact User i...

Page 24: ...has dried off before switching on the system For cleaning the components and accessories head rest surgical instruments and the localizer refer to the cleaning recommendations included in the corresponding instructions for use CAUTION Never spray or pour cleaning solution or disinfectant directly onto the surface because there is a risk that the cleaning agent comes into direct contact with the co...

Page 25: ...ried 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 safety measures are taken into account during maintenance work to prevent damage and injuries NOTE We recommend to keep a medical devices book for the repair and maintenance work carried out Take n...

Page 26: ...H E 01 1103 DOC 18 00147 1 09 2018 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 ...

Page 27: ...xed with the CE marking Therefore it is compliant with the following directive MDD 93 42 EEC 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 us under the following address Fiagon GmbH Neuendorfstraße 23b 16761 Hennigsdorf Germany Phone 4...

Page 28: ...sation Air pressure 1060 hPa to 700 hPa Transport conditions Temperature 10 C to 35 C Humidity 30 to 75 without condensation Air pressure 1060 hPa to 700 hPa Storage conditions Protected against dust and moisture Recommended storage temperature 15 to 35 C Humidity 30 to 75 without condensation Air pressure 1060 hPa to 700 hPa Warning If the system is transported indoor after outdoor placement wait...

Page 29: ...ion Test RF emissions following IEC CISPR 11 Compliance group 1 Electromagnetic Environment Guidance The 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 system is suitable for use in all establishments including domestic est...

Page 30: ...ve amplitude 40 UT for 100 ms 70 UT for 500 ms 5 UT 5000 ms 3 A m Compliance Level Level 6kV cd 8kV ad 2kV mains 1kV I O 1kV dm 2kV cm Reduction to 5 for 10 ms positive amplitude 5 UT for 10ms negative amplitude 5 UT for 10ms negative amplitude 40 UT for 100 ms 70 UT for 500 ms 5 UT 5000 ms 3 A m Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are cove...

Page 31: ... and d is the recommended 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 strengths from fixed transmitters such as base stations for radio cellular cordless telephones and l...

Page 32: ...f transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable t...

Page 33: ...ents provided by Fiagon or its representatives Patient localizer Extension cable localizer 2 m A 001201 Patient localizer Patient localizers various Patient localizers provided by Fiagon or its representatives Mains connector Mains power cord uL Approved 1 80 m A 21 9200 Power Supply Cord Hospital Grade UL Approved according to UL 817 3 m A 21 9201 Warning The use of accessories and cables other t...

Page 34: ...ps Siemens GE Kodak Morita 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 Monitors The navigation module can only be connected...

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