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Electromagnetic compatibility

The fusionTrack is medical electrical equipment and needs special precautions regarding EMC and needs
to be installed and put into service according to EMC information provided in this document.

EMC tests have not included any AC-adapter with the product.

Applied standards
EN 60601-1-2:2007 +AC:2010
IEC 60601-1-2:2007 (ed3.0)

Medical electrical equipment – Part 1-2: General re-
quirements for basic safety and essential performance
– Collateral standard: Electromagnetic compatibility –
Requirements and tests

EN 60601-1-2:2015
IEC 60601-1-2:2014 (ed4.0)

Medical electrical equipment – Part 1-2: General re-
quirements for basic safety and essential performance
– Collateral standard: Electromagnetic compatibility –
Requirements and tests

Electromagnetic emissions
The fusionTrack is intended for use in the electromagnetic environment specified below. The integrator, the customer
or the user should assure that it is used in such an environment.
Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions
EN 55011:2016
CISPR 11:2015 (ed6.0)

Group 1

The fusionTrack 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 elec-
tronic equipment.

RF emissions
EN 55011:2016
CISPR 11:2015 (ed6.0)

Class B

The fusionTrack is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply net-
work that supplies buildings used for domestic pur-
poses.

Harmonic emissions
EN 61000-3-2:2014
IEC 61000-3-2:2014

Not applicable

Voltage fluctuations / Flicker emissions
EN 61000-3-3:2013
IEC 61000-3-3:2013

Not applicable

Use of the fusionTrack adjacent to, or stacked with other
equipment should be avoided because it could result in im-
proper operation and can lead to wrong measurements to
serious injury including death. If such use is necessary, the
fusionTrack and the other equipment should be observed to
verify that they are operating normally.

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Содержание fusionTrack 500

Страница 1: ...witzerland www atracsys measurement com Atracsys Support smith nephew com Tel 41 0 21 533 09 00 fusionTrack 500 User manual File name fTk500_InstructionsHowToUse pdf Document type Manual Version v4 5 2 Revision 8403a38 Pages 113 Date 17th June 2020 ...

Страница 2: ...re requirements 15 3 2 The fusionTrack device 16 3 2 1 Power input 17 3 2 2 Cables 19 3 2 3 Status LEDs 19 3 3 The fusionTrack software development kit 19 3 4 Authorised modifications 19 4 Shock sensor 21 4 1 Registers 21 4 1 1 Status register 21 4 1 2 Error register 22 5 Hardware installation 23 5 1 Operating environment requirements 23 5 2 Least favorable working conditions 24 5 3 Transportation...

Страница 3: ...0 Stray fiducials 44 8 Using the fusionTrack system 45 8 1 The fusionTrack system options 45 8 1 1 Library related options 46 8 1 2 Device related options 46 8 1 3 Detection stage related options 50 8 1 4 Wireless related options 51 8 1 5 Authentication related options 51 8 1 6 Environment and options 52 8 2 User interface software demo exe 52 8 2 1 Recalibration of a marker 57 8 2 2 Exporting the...

Страница 4: ... tool from Atracsys 78 14 Electromagnetic compatibility 79 14 1 Essential performances 81 14 1 1 Quality of the measurement 81 14 1 2 Measurement rate 82 14 2 Cables 83 15 Communication parameters 84 15 1 Changing the IP 84 15 2 Changing the local UDP port 85 15 3 Connection to multiple fusionTrack devices 85 16 The fusionTrack device authentication 87 16 1 Implementation 87 16 2 Setting the key i...

Страница 5: ...95 19 2 Hashing code 95 19 3 About JsonCpp 95 19 4 About Qt 96 19 5 About FreeGLUT 97 19 6 About Coin3D 97 19 7 Base 64 97 19 8 About FLTK 98 A Mathematical considerations 99 A 1 Homogeneous coordinates 99 A 2 Marker pose 99 A 3 Inverting a marker pose 100 B Warning summary 101 References 113 ...

Страница 6: ...outines protocols and tools for building software applications Fiducial Simplest element sphere covered with reflective material sticker with reflective material reflective glass sphere IR LED detected by the optical tracking system and reconstructed as a three dimensional point e g x y z coordinates GUI Graphical User Interface this is a type of interface that allows users to interact with electr...

Страница 7: ... by a PoE The fusionTrack is a PD PoE Power Over Ethernet providing both an Ethernet connection and power supply using only one Eth ernet cable PSE Power Source Equipment when talking about a device powered by a PoE The PSE provides power to the PD Raw data Image of a fiducial on a camera SDK Software Development Kit which is typically a set of software development tools that allows the creation o...

Страница 8: ...tracsys prior to proceeding Atracsys makes no expressed or implied warranty of any kind with regard to this document or the programs and data on the electronic media accompanying this document Atracsys makes no representation condition or warranty to the user or any other party with respect to the adequacy of this document or accompanying media for any particular purpose or with respect to its ade...

Страница 9: ...step The integrator has to check that the device position of the device is well suited for the application surgery and that required regulations are respected Optical hazards according IEC 62471 1 Exempt group The fusionTrack device uses powerful infrared LEDs for illu mination and communication This infrared light at approx imately 850 nm is not visible by human eyes According to the standard IEC...

Страница 10: ...ests related to the electrical security and electromagnetic compatibility for the whole sys tem 1 2 Caution In the whole documentation cautions are indicated with this symbol and graphics The information from the accompa nying paragraph must be followed to avoid damaging the equipment 1 3 Safety signs and symbols Various symbols are used in this manual the user s manual and on the product itself t...

Страница 11: ...mperatures See Section 5 3 The fusionTrack device must not be disposed of in the trash see Section 17 4 The extension port must not be used See Figure 3 3 LASER RADIATION Do not stare into beam Class 2 Laser Product λ 400 700nm Po 1 mW 1 4 Device label This section details the information printed on the label of the device An example is provided on Fig ure 1 1 The label gives the serial number of ...

Страница 12: ...y question regarding the content of this guide or the operation of this product please contact us Atracsys LLC Route du Verney 20 1070 Puidoux Switzerland www atracsys measurement com Atracsys Support smith nephew com Tel 41 0 21 533 09 00 1 7 Updates The latest version of this document can be downloaded from Atracsys website The address as well as the required username and password are provided b...

Страница 13: ...idely used in the medical field With its unparalleled measurement speed accuracy and latency the fusionTrack 500 is ideally suited for robotic applications The fusionTrack system is one of the components of an IGS tool The final i e surgical application will depend on the requirements of the integrator The fusionTrack measures distances and angles between markers fixed on the patient as well as ma...

Страница 14: ... 1 Figure 2 1 Accuracy Measurement volume xz projection Figure 2 2 Accuracy Measurement volume yz projection The volume presented on Figure 2 1 and Figure 2 2 is the validated volume i e the volume in which the trueness of the fusionTrack device is checked This volume is obtained from the smoothed union of all AVT boxes as such it is larger than the actual seen volume at low z This is due to the f...

Страница 15: ...marker 6 spheres discs IR LEDs per marker Software Development Kit SDK C C shared library Operating systems Windows Linux see Section 3 1 Power requirements Power over Ethernet PoE IEEE 802 3at 2009 48 V 0 6 A Pollution degree 2 Overvoltage category I Acoustic energy 80 dB Laser Class 2 Standards Basic safety and essential performance IEC 60601 1 2005 A1 2012 Ed 3 1 Electromagnetic disturbances IE...

Страница 16: ...tions and rotations in respect to the fusionTrack housing the fixation base The fusionTrack is designed to provide accurate relative measurements Relative measurements means that position and rotation from one respectively several markers to each other are computed Figure 3 1 Sketch of the fusionTrack device The cameras in blue are mounted on a rigid rod in green This rod is fixed to the shell gre...

Страница 17: ...ce of data allowing the user to do additional processing display filtering collection etc The fusionTrack device can track two types of markers passive and active ones More detailed explanations about those two marker types are given in Section 7 6 The fusionTrack device must be powered off when not in use e g using a switch before the PoE PSE The powered on time be the fusionTrack device used or ...

Страница 18: ...connections Finally the two LEDs indicate the status and the speed of the Ethernet communication see Section 3 2 3 The extension port 10 is not intended for user connections Do not connect anything on this plug 3 2 1 Power input The used power supply must be a limited power source Any used power supply must not be able to deliver more than 100 W The integrator has to implement a mean to isolate th...

Страница 19: ...nteroperability issues are listed in Table 3 3 Using an improper passive injector may damage the device Section 3 2 2 also provides valuable information regarding providing power to the fusionTrack device Property 802 3at Type 2 Also known as PoE PoE plus Power available at PD 25 50 W Max power delivered by PSE 30 0 W Voltage range at PSE 50 0 V to 57 0 Va Voltage range at PD 42 5 V to 57 0 Vb Max...

Страница 20: ... no negociation phase takes place and it is always guaranteed that the fusionTrack receives power Both shielded and unshielded cables work perfectly Using a PoE PSE In this case the usage of unshielded cables before and after the PSE presents less problems Ground loops between the PSE and the PC have to be avoided i e the main power connections of the PSE and the PC have to be connected together i...

Страница 21: ...ga c Link 1000BASE T PoE Unknown Green Flashinga c Link 1000BASE T PoE Type 2 Ethernet TX LED Red Flashingb c Link 10BASE T PoE Type 2 Unknown Yellow Flashingb c Link 100BASE T PoE Unknown Orange Flashingb c Link 100BASE T PoE Type 2 Blue Flashingb c Link 1000BASE T PoE Unknown Green Flashingb c Link 1000BASE T PoE Type 2 User Status LED User Status LED is available for the user to indicate person...

Страница 22: ...ock event over the threshold has happened the user is informed over the SDK if the corresponding option is activated The battery is automatically recharged each time the fusionTrack device is powered Therefore in a regular usage scenario the battery is always almost fully charged A completely empty battery is fully recharged in 24 h The system runs autonomously for approximately 6 months without r...

Страница 23: ...lure on accelerometer 0 is detected The failure is critical Bit 3 RTC failed The flag is set to 1 when failure on the real time clock is detected The failure is critical Bit 2 EEPROM failed The flag is set to 1 when a failure on the non volatile memory is detected The failure is critical Bit 1 No battery The flag is set to 1 when the battery is empty The failure is critical Bit 0 Shock The flag is...

Страница 24: ...be located in the sterile area The fusionTrack must not be used if a hot hair outlet is present between the fusionTrack and the markers The re fraction index changes of the hot and cold air interfaces could cause wrong measurements The fusionTrack has to be placed horizontal An orientation other than horizontal e g vertical can detoriate precision due to thermal gradients inside the device To allo...

Страница 25: ... only one functioning mode therefore no least favorable working conditions exist 5 3 Transportation and storage environmental conditions The integrator of the fusionTrack system must take care of the mechanical stability of the fusionTrack at all times when the fusionTrack is in use but also when it is not powered Effectively the calibration of the device may be invalidated if the device suffered ...

Страница 26: ...hen it is not powered Effectively the calibration of the device may be invalidated if the device suffered from shocks drop and strong vibrations The fusionTrack must therefore be firmly fixed to avoid any fall and should be mounted on a structure which minimises the probability of shocks drops and vibrations When installed on a tripod or on a cart special care has to be taken to avoid tipping over...

Страница 27: ...erformance a Actually the last byte can be anything but 7 which corresponds to the device IP Table 5 4 Default network settings Number of fidu cials Gigabit Ethernet 1000BASE T 1000 Mbit s 100BASE T 100 Mbit s Ethernet MTU 1500 bytes no Jumbo Frame Ethernet MTU 9014 bytes Jumbo Frame Ethernet MTU 1500 bytes no Jumbo Frame Ethernet MTU 9014 bytes Jumbo Frame CPU load Network Mb s Frame Rate Hz CPU ...

Страница 28: ... Type B applied part it is only considered as Type B applied part Therefore only the two following requirements have to be respected Requirements of the 60601 1 to provide protection against electric shock Requirements of the 60601 1 regarding touch current enclosure leakage current fusionTrack protection against electric shock The fusionTrack is certified following the medical standard 60601 1 Fo...

Страница 29: ...ormation systems The combination of a fusionTrack system on a system following IEC 60950 1 is respecting 2 MOPP This means that as long as the computer or its peripherals screen mouse keyboard have not to be considered as applied parts Type B i e they are outside of the patient environment of 1 5 m there is no possible direct or indirect contact between the patient and this equipment it is not man...

Страница 30: ... Type B Type BF or Type CF according to the nature of the device and the type of contact Each classification has differing requirements from the point of view of protection against electrical shock Type CF is the most stringent classification being required for those applications where the applied part is in direct conductive contact with the heart or other applications as considered necessary Typ...

Страница 31: ...Atracsys 6 1 Windows installation The installer for Windows is a wizard which allows an easy installation with possible customisation of the setup Depending on the target environment Visual Studio redistributables will be automatically installed as well 6 2 Linux installation The Linux package consists of a compressed tarball 1 tar xJvf fusionTrack_v_4_1_1 gcc 5 4_x64 tar lzma 2 cd fusionTrack_v_4...

Страница 32: ...e 7 1 and Figure 7 2 Its origin is the optical centre of the left camera Unless specified otherwise all distances are expressed in millimetres mm The fusionTrack contains an accelerometer whose system of coordinates has its x axis opposite to the y axis of the camera system of coordinates Its y axis is colinear to the fusionTrack cylinder pointing from the right camera to the left one Figure 7 1 C...

Страница 33: ...cked by the fusionTrack device the markers must lie inside the working volume de scribed in Figure 7 3 It should be noted this volume is not the same as the validated volume shown on Figure 2 1 and Figure 2 2 Figure 7 3 fusionTrack tracking volume ...

Страница 34: ...tation matrix registration error in mm corresponding to the result of the least square minimisation between the marker geometry and the measured fiducial positions the geometrical id corresponding to the id field from the geometry file Section 7 7 a tracking id giving a unique number to identify a marker on a frame a mask indicating which fiducials have been used to reconstruct the marker i e if b...

Страница 35: ...s outside the theoretical field of view the picture header information consisting of the header status indicating if an error occurred when retrieving the data the picture dimensions the picture counter a unique and consecutive generated number the picture timestamp corresponding to the time in µs since the device startup the timestamp is taken at the start of the image exposure the picture image ...

Страница 36: ...t to the fusionTrack sensors For active fiducials the fusionTrack emits an IR signal which triggers the LED emission on the connected marker In both cases the IR light is detected by the fusionTrack sensors in the same way The fusionTrack SDK then builds fiducials by combining pairs of raw data wrong combinations are rejected using the epipolar error explained in Section 7 9 The reconstructed fidu...

Страница 37: ...et of calibration parameters indexed by a synthetic temperature value On each frame the current synthetic temperature value is computed and a calibration is either interpolated or extrapolated from the ones con tained in the calibration file New events see Section 7 3 1 have been added to allow the user to get the current synthetic temperature and the value of the synthetic temperature when the de...

Страница 38: ...tries A marker is assumed to be calibrated and sterile Fiducials are assumed to be correctly fixed on the marker Instructions about fixing fiducials on markers must be clearly specified by the integrator in the end user manual Sterile markers fiducials or battery packaging must be opened inside the Operating Room OR The integrator has to specify in the user manual to open sterile markers fidu cial...

Страница 39: ...and tracks the markers using the geometry of the fiducials on the marker The fusionTrack device needs a geometrical description of each tracked marker this description is called the geometry file Several causes related to markers might cause wrong measurements Even when the marker itself has not been geometrically deformed any damages on fiducials might be an issue when a fiducial is particularly ...

Страница 40: ... LEDs mounted in a rigid structure The LEDs can either emit continuously or be synchronised with the fusionTrack cameras In the latter case the marker also contains an IR receiver An active marker is powered by a battery or from the equipment to which it is attached Those markers can either be wired or wireless The fusionTrack device IR communication sends a pattern which is recognised by the IR r...

Страница 41: ...n a polarity marking and a polarity inversion circuit on the marker The measurement precision of an active marker can be deto riated because of liquids on its fiducials or IR receptor In structions about identifying and cleaning of active fiducial must be clearly specified by the integrator in the end user manual An active fiducial marker must be sterilised before each us age Cleaning or sterilisa...

Страница 42: ...ains the following information A geometry section containing a count key which indicates the number of fiducials at least 3 at most 6 composing the marker an id key indicating the unique id of the geometry A fiducialX section for each fiducial where X goes from 0 to n 1 n being the number of fiducials composing the marker described by the count key Each fiducialX section contains the coordinates o...

Страница 43: ...polar max distance The epipolar max distance affects the raw data pairing The epipolar error tolerance expresses the distance in pixels between the centroid of the raw data from the right camera and its expected position deduced from the centroid position on the left camera The bigger the tolerance the higher the probability of finding a matching pair however the probability of creating a phantom ...

Страница 44: ...ob detection The edge blob detection option is a binary option enabled by default When it is on the raw data located at the edges of the sensor are rejected because their computed position i e the centroid are known to be biased by the missing part of the raw data This has then an impact on the reconstructed 3D position of the fiducial leading to a wrong estimation of the position and orientation ...

Страница 45: ... reported positions Using stray fiducial positions may lead to hazardous situations such as IR transmitter incandescent light reflections or other IR source may be reconstructed as a stray fiducial There is no way to identify a stray fiducial i e its id number may change from one frame to the next The application must therefore perform checks based on the position to ensure an identification of th...

Страница 46: ...s have been chosen to ensure optimal tracking performances Changing them might impact the performances of the fusionTrack system The fusionTrack device must be cleaned as described in Chapter 17 The Atracsys SDK is shipped with precompiled softwares From the install directory they can be found in the relative path fusionTrack SDK bin Their use is described in the following two sections Each soft w...

Страница 47: ...ch are options not directly linked to a specific device Name Type Description Library Version ftkBuffer read only global Allows to read the SDK full version string Device library version ftkBuffer read only global Allows to read the device layer library full version string Data directory ftkBuffer read write global Allows to access the path from where the marker calibration files and AVT software ...

Страница 48: ...only Allows to read the current temperature sensor reading for the index set with the Temperature sensor index option Reading a value before set ting a valid index will result in an error Temperature sensor ref erence float32 read only Allows to read the median temperature sensor value for the index set with the Temperature sen sor index option during the calibration Reading a value before setting...

Страница 49: ...eriod int32 read write permanent Allows to access the interval in seconds be tween two checks of the shock sensors When set to default value 0 there will be no reporting of shocks For any positive value the fusionTrack device will check at the set interval if a shock oc cured and the ftkGetLastFrame function will re port the FTK_WAR_SHOCK_DETECTED warning Shock sensor threshold int32 read only per...

Страница 50: ...ed by the device layer library for instance because one UDP packet was dropped Reading this option before setting Copies lost counters will result in an error Copies lost counters int32 write only Copies the internal values accessed by the Counter of lost frames and Counter of cor rupted frames options Resets lost counters int32 write only Resets the internal values accessed by the Counter of lost...

Страница 51: ...uted as the point between the left and the right cameras Epipolar Maximum Dis tance float32 read write Defindes the maximum distance in pixels be tween the right raw data and the right epipolar line defined by the left candidate during the match search Matching Tolerance float32 read write Defines the tolerance in mm between the mea sured and reference lengths defined by two fidu cials of a marker...

Страница 52: ...2 write only Resets a wireless marker using its short ID Marker button stream ing int32 read write Toggles the periodic scanning of the wireless button status and the its streaming in the ftkFrameQuery events member If the En able pairing option is enabled the streaming is disabled whatever the value of this option Marker battery stream ing int32 read write Toggle the periodic scanning of the wire...

Страница 53: ... demo exe The Atracsys SDK documented in 1 is shipped with a precompiled GUI program This program is run by executing demo64 exe This program consists of a main window which is composed of several panels and a secondary window showing a 3D representation of the scene Windows only The GUI demo software is not part of the fusionTrack soft ware system It is only meant to provide a showcase of what ca...

Страница 54: ...onding to the data at different processing stages Raw data which are the blobs detected on each picture 3D which consist of a 3D point reconstructed from a pair of raw data Marker consisting of a 3D position and a rotation matrix this is what is shown on Figure 8 1 The demo allows to open the two storage locations in order to see the files Lower panel Below the two pictures is located a dockable t...

Страница 55: ...hing 5 Display The Device related option tab contains the following options Serial Number which is the serial number of the tracking device This option is read only Image Compression Threshold Image Integration Time Picture rejection threshold Enable data sending Enable IR strobe User LED red component User LED green component User LED blue component User LED frequency Enables the user LED Shock m...

Страница 56: ...ess Pointer 73 and Wireless Development Kit 98 PCB Version This value identifies the version of the electronic the PCB in the marker PCB Assembly This value identifies the version of the electronic parts assembled on the PCB Mechanical version This value identifies the version of the mechanicals parts of the marker Geometry The identifier of the geometry used for the tracking The same value can be...

Страница 57: ...GUI i e they do not correspond to any option from the SDK They are Display images enables picture display This can have an impact on the GUI framerate on low end PCs Display error info in images enables showing additional information on the picture i e aspect ratio for the raw data epipolar and triangulation errors for fiducials registration error for markers Update Timer Timeout allows to limit t...

Страница 58: ...ted that the demo exe software acquires data from the fusionTrack at the display update rate This means that exported values won t be recorded at the maximum speed of the fusionTrack The user can choose which data to export the default setting is to export everything i e to create three files The number of frames to record can be set in which case the saving will automatically stop when this numbe...

Страница 59: ...he Record button triggers the choice of the output directory Then the record starts until the user hits Stop recording or the number of frames to record is reached The file name consists of the prefix followed by by the device serial number in hexadecimal and the current timestamp e g Dumper_0xbb000005c21ffa28_2017 11 07_14h39m53 xml 8 3 Command line software samples The Atracsys SDK is also shipp...

Страница 60: ...d ftk6_ControlLED presents how to control the user LED by setting the LED colour the red green and blue components can be set individually and its blinking frequency ftk7_AcquisitionExtended demonstrates how to get additional information on the current frame The sample contain an example of how to get the real number of reconstructed 3D fiducials even if no storage has been reserved for the 3D fid...

Страница 61: ...User manual Version v4 5 2 Figure 8 4 Temperature sensors location top view Figure 8 5 Temperature sensors location isometric view ...

Страница 62: ...s the following information non exhaustive list date and time device serial number and type SDK version values of the various options values of the fusionTrack device internal registers ftk19_OpticalCommunication presents how the to get a wireless marker battery and button status using events ftk20_Latency provides a way to study the relation between latency and the Picture rejection threshold so ...

Страница 63: ... hardware level and the software acquisition time i e time between two picture acquisition at the host PC level 8 4 1 Running the software The user can steer the behaviour of the software via the following options number of recorded frames in each loop set via the f nbframes M switch number of loops set via the n nbloops N switch tolerance on the maximum time between two acquisitions at the host P...

Страница 64: ...ding period mean 2986 27 us STD 73 1067 us min 2985 us max 8955 us median 2985 us 19 20 UPDATE TIME TEST 21 Host User PC time between updates mean 2986 37 us STD 161 047 us min 11 093 us max 9297 64 us median 2986 1 us 22 Acceptance criteria Update time maximum 30000 us Test result PASSED 23 24 MAX downstream latency TEST 25 Host Latency time added downstream from the device for measurement frames...

Страница 65: ...file can be written and open a terminal in this directory either cmd or PowerShell 2 From the aforementioned terminal run cmake G generator_string A x64 path_to_the_sample_dire command Valid examples are 1 cmake G Visual Studio 15 2017 Win64 C Program Files Atracsys fusionTrack SDK samples 2 cmake G Visual Studio 16 2019 A x64 C Program Files Atracsys fusionTrack SDK samples 3 Open the samples sln...

Страница 66: ...d through Pypy The wrapper needs Python 64 bits git CMake 3 10 or newer and a C 11 compliant compiler i e Microsoft Visual Studio 2015 or newer gcc 5 0 or newer clang 3 8 or newer 9 2 Matlab wrapper A Matlab wrapper is distributed which has been tested with Matlab R2016a and Microsoft Visual Studio 2015 on Windows It consists of a set of C source files which are then compiled via Matlab using Visu...

Страница 67: ...the Matlab wrapper On Listing 9 2 is presented how to initialise the wrapper enumerate connected devices and get the SDK version A geometry is then registered and finally a frame is retrieved showing 4 fiducials and a marker 1 trSystem FusionTrack 2 3 trSystem 4 5 FusionTrack with properties 6 7 FTK_OPT_DRIVER_VER 4 8 FTK_MIN_VAL 0 9 FTK_MAX_VAL 1 10 FTK_DEF_VAL 2 11 FTK_VALUE 3 12 version 1 13 14...

Страница 68: ...d the fusionTrack to be correctly established It is estab lished when the serial number is printed in the console and when the device status LED is blinking in blue If the fusionTrack beeps twice in a row and the status LED is solid green then the procedure must be started again from step 2 10 2 Updating the firmware of the fusionTrack The update of the fusionTrack firmware is done through the com...

Страница 69: ...on 10 1 The update procedure is the following 1 Use the command update_shockSensor to upload the shock detection unit firmware in the fusionTrack see Figure 10 2 For example 1 update_shockSensor C Users john doe Download fTk_accMega_0 0 1 09 bin Listing 10 2 Uploading the new shock sensor detection unit firmware to the fusionTrack 2 The device will beep twice 3 Wait for OK to be displayed See Figu...

Страница 70: ... reboot the marker 2 As soon as the led on the marker is in purple use the command update_wMarker to upload the wireless marker firmware see Figure 10 3 For example 1 update_wMarker home john doe Downloads wTm_a_00000037 bin Listing 10 3 Uploading the active marker firmware to the marker The firmware is different depending on the type of the marker Marker type Firmware name Wireless Boomerang Mark...

Страница 71: ...aded from the device 2 The data is sent to Atracsys processing server and the pdf report is sent by email The procedure is the following 1 Use the command dlEEPROM to download the data and send them to Atracsys For instance dlEEPROM your_email_address 2 Wait for OK to be displayed 3 Boot the device in application firmware by switching off and after 5 s on again or by running the reset 1 command An...

Страница 72: ...monitoring of the registration error see Section 11 2 2 the zeroing method described in Chapter 12 3 the accuracy assessment method described in Chapter 13 The two last methods guarantee the fusionTrack is operational in the configured environment by checking the calibration integrator settings and environment configuration The zeroing method must be performed before the navigation procedure is st...

Страница 73: ...grator shall state in their user manual that no objects in the field of view are allowed but the markers pointers or surgical tools A large registration error can be caused by a scratched fidu cial liquids on fiducial damaged fiducial wrongly fixed fidu cials on the marker or a deformed marker The integrator must generate an error message when the marker registra tion error is too high 11 3 Contro...

Страница 74: ...Chapter 17 11 5 Control environmental conditions Instability of the fusionTrack device can cause injury by falling on patient or operator Attachment between feet and hold ing mechanism must be perfectly stable Instructions indi cating how to fixate fusionTrack using the threads in the feet are provided in Section 5 4 Polluting light in the field of view might lead to wrong mea surements The integr...

Страница 75: ...ionTrack device misuse of the SDK or misuse of the OS functionalities might cause wrong measurements causing patient injury The integrator should perform unit tests during the development process to vali date configured settings The integrator must take care that the host PC meets the SDK and their software requirement especially the needed memory and the nominal CPU usage must be paid attention t...

Страница 76: ...re failure might cause wrong measurements The in tegrator should perform unit tests during the development process to validate the software functionality On Unix Linux the integrator must ensure the software is functional with the used GNU C library C Standard Li brary and POSIX thread versions The integrator must generate a noisy environment error message when the environment is poluted with refl...

Страница 77: ...er and an additional marker the latter is required to have a cavity in which the tip of the pointer must fit whatever the pointer position and orientation e g a cone or a cylinder as illustrated in Figure 12 1 Once the pointer tip has been inserted in the marker cavity the pointer should be rotated around its tip which must remain in the marker cavity The fusionTrack records the position and orien...

Страница 78: ...ive markers is changed The operator for this test is the surgeon How to proceed must be clearly stated in the user manual Any liquid on lenses such as body fluids ejection or conden sation could lead to wrong measurements Lenses have to be cleaned as soon as they get in contact with liquids The zeroing method has to be re performed after each cleaning Some disposable passive fiducials cannot be cl...

Страница 79: ...nitor the marker s registration error as well as the dis tances between the marker s fiducials If the used marker is accuratly calibrated it may be enough to look at the width of the distribution of the registration error The integrator must specify an upper bound on this width above which the test is considered to fail In general monitoring the distance between two fiducials of the marker is a su...

Страница 80: ...d assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions EN 55011 2016 CISPR 11 2015 ed6 0 Group 1 The fusionTrack 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 elec tronic equipment RF emissions EN 55011 2016 CISPR 11 2015 ed6 0 Class B ...

Страница 81: ... VRMS 150 kHz to 80 MHz 6 VRMS ISM bands 3 VRMS 150 kHz to 80 MHz 6 VRMS ISM bands Portable and mobile RF communications equip ment should be used no closer to any part of the fusionTrack including cables than the rec ommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P 150 kHz to 80 MHz d 0 35 P 80 MHz to ...

Страница 82: ...35 0 70 10 3 8 1 1 2 2 100 12 0 3 5 7 0 For transmitters rated at a maximum output power not listed above the recommended separation dis tance d in metres m can be determined 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 Notes At 80 MHz and 800 MHz the separation d...

Страница 83: ...images Ethernet link speed host PC OS blocked optical path and many more In the typical setup that was tested the measurement rate was not affected by any of the electromagnetic immunity tests stated in the Table 14 1 except for the following cases Immunity test Note ESD discharges Communication status LED might blink shortly on discharges Electrical fast transient burst Acquisition rate might tem...

Страница 84: ...14 2 Cables Access Length Type Screened Ethernet RJ 45 port 100 1000 Mbps PoE max 100 ma Cat 5e or better un shielded a Total length i e before and after a potential PoE injector Not intended to connect directly to outdoor cables ...

Страница 85: ...55 192 168 0 0 192 168 255 255 When changing the IP the user must carefully note the new IP otherwise it may be difficult to connect to the device again 1 Use the set_ip to set the new IP for instance 1 set_ip 172 16 2 4 2 Wait for New IPv4 address set Please reset device to be printed 3 Either reboot manually the device or use the reset 0 command 4 Quit atnet with the exit command Once a new IP h...

Страница 86: ...rk 3 4 version 1 5 interfaces 6 7 address 172 17 1 7 8 port 3509 9 localPort 13485 10 11 12 13 Listing 15 2 JSON file trying to force the local UDP port 15 3 Connection to multiple fusionTrack devices The new ftkInitExt function also allows to use the same library handle to connect to more than one fusionTrack device The recommended way to do it is to use one dedicated Ethernet adapter per fusionT...

Страница 87: ...User manual Version v4 5 2 12 port 3509 13 14 15 16 Listing 15 3 Example of configuration allowing the connection to 2 fusionTracks ...

Страница 88: ...ions The challenge consist into sending data to the tracker and receiving back the encrypted version of the data The encryption is done using the pre programmed keys The encrypted challenge received from the fusionTrack device is compared to the challenge encrypted by the SDK The chosen algorithm is XTEA 3 eXtended TEA with a 128 bits key and 64 bits challenges This algorithm was chosen for its si...

Страница 89: ...ong It will fail if no key has previously been set or if the last request was performed less than 1 s ago Finally the integer Challenge result option allows to check wether the two encrypted challenges i e the one computed by the fusionTrack device and the SDK are the same in which case a 1 is returned or not in which case a 0 is returned A full example is shown on Listing 16 3 1 The uploaded file...

Страница 90: ...ize 8u 42 43 if ftkSetData lib sn requestChallengeId buffer ftkError FTK_OK 44 45 handle error 46 47 48 int32_t result 0 49 50 if ftkGetInt32 lib sn checkChallengeId result 51 ftkOptionGetter FTK_VALUE ftkError FTK_OK 52 53 handle error 54 55 56 if value 1 57 58 cout Device successfully authenticated endl 59 60 else 61 62 cerr Could not authenticate device endl 63 Listing 16 3 Full example of key ...

Страница 91: ...User manual Version v4 5 2 Figure 16 1 The Authentication tab in the GUI demo allows to check a key by requesting a challenge to the connected fusionTrack ...

Страница 92: ...ng solutions Eyeglass lens tissues must not be used as it may scratch the lens Other surfaces must be dried using a clean and dry cloth The device must be turned off and disconnected prior to cleaning The disinfecting detergent must not be spilled di rectly onto the device or any of its components It must be ensured that no fluids enter the fusionTrack This may damage the fusionTrack by causing sh...

Страница 93: ...nd therefore to poor tracking accuracy The loss of tracking accuracy can be detected using the procedure described in Chapter 13 In the case of a device not passing the test it should not be used anymore and sent back to Atracsys for repair 17 4 Disposal of equipment To ensure environmentally responsible disposal decommissioned equipment please contact Atracsys see Section 1 6 ...

Страница 94: ...e are common if using 100BASE T cables instead of 1000BASE T ones The user should check that the used cables are intact a 1000BASE T cable with a broken wire pair might be detected as a 100BASE T cable leading to the same rate restrictions Both problems can be detected by looking at the RX TX LEDs at the back of the device see Section 3 2 3 18 1 2 PoE problems If the fusionTrack device seems to ha...

Страница 95: ...se contact Atracsys for more information In order to determine whether a harming shock occurred during the shock sensor downtime an accu racy verification must be performed See Chapter 13 18 1 5 FTK_WAR_SHOCK_SENSOR_AUTO_ENABLE warning If the ftkGetLastFrame function returns the ftkError FTK_WAR_SHOCK_AUTO_ENABLE warning it means that the fusionTrack shock sensor was offline for a moment and autom...

Страница 96: ...the author be held liable for any damages arising from the use of this software Permission is granted to anyone to use this software for any purpose including commercial applications and to alter it and redistribute it freely subject to the following restrictions 1 The origin of this software must not be misrepresented you must not claim that you wrote the original software 2 If you use this softw...

Страница 97: ...ons of the Software THE SOFTWARE IS PROVIDED AS IS WITHOUT WARRANTY OF ANY KIND EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY FITNESS FOR A PAR TICULAR PURPOSE AND NONINFRINGEMENT IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM DAMAGES OR OTHER LIABILITY WHETHER IN AN ACTION OF CONTRACT TORT OR OTHERWISE ARISING FROM OUT OF OR IN CONNE...

Страница 98: ...e into stagnation FreeGLUT is in development to improve the toolkit It is released under the MIT License 19 6 About Coin3D The demo software uses Coin3D Coin3D is a high level retained mode toolkit for effective 3D graphics development It is API compatible with Open Inventor 2 1 Coin3D is Free Software published under the BSD 3 clause license 19 7 Base 64 The demo software uses base 64 encoding by...

Страница 99: ...constitute a derivative work 4 Static linking of applications and widgets to the FLTK library does not constitute a derivative work and does not require the author to provide source code for the application or widget use the shared FLTK libraries or link their applications or widgets against a user supplied version of FLTK 5 If you link the application or widget to a modified version of FLTK then ...

Страница 100: ...ither via the ftkMarker rotation or the atracsys MarkerData _Rotation fields The ftkMarker rotation matrix is stored such that it is accessed like this ftkMarker rotation rowId columnId and the information is simply copied into the atracsys MarkerData _Rotation field i e indices are used in the same way Consider the following example taken from the simulator data in which a marker with geometry ID...

Страница 101: ...dinates it can be checked easily that R t 0 1 pi 1 xi 1 i 0 3 R t 0 1 p0 1 190 802 110 569 872 977 1 x0 1 R t 0 1 p1 1 198 099 75 386 870 775 1 x1 1 R t 0 1 p2 1 237 889 75 902 874 949 1 x2 1 R t 0 1 p3 1 222 010 116 581 876 743 1 x3 1 A 3 Inverting a marker pose If the position and orientation of a marker is needed in the coordinate system of another marker the trans formation should be inverted ...

Страница 102: ...ired regulations are respected Optical hazards according IEC 62471 1 Exempt group The fusionTrack device uses powerful infrared LEDs for illu mination and communication This infrared light at approx imately 850 nm is not visible by human eyes According to the standard IEC 62471 1 hazard values are reported at a fixed distance d 200 mm the fusionTrack is classified in the Exempt group To further re...

Страница 103: ...ical security and electromagnetic compatibility for the whole sys tem The extension port 10 is not intended for user connections Do not connect anything on this plug The used power supply must be a limited power source Any used power supply must not be able to deliver more than 100 W The integrator has to implement a mean to isolate the fusion Track electrically from the supply mains The fusionTra...

Страница 104: ...se the integrator shall apply chapter 14 13 of IEC 60601 1 This section is provided as information only the integrator has to discuss and verify the fusionTrack integration with a certification body The fusionTrack is designed to provide accurate relative measurements and should not be used to perform abso lute measurement See Chapter 3 for more information Most of the functions of the API return ...

Страница 105: ...tries A marker is assumed to be calibrated and sterile Fiducials are assumed to be correctly fixed on the marker Instructions about fixing fiducials on markers must be clearly specified by the integrator in the end user manual Sterile markers fiducials or battery packaging must be opened inside the Operating Room OR The integrator has to specify in the user manual to open sterile markers fidu cial...

Страница 106: ...event badly reconstructed data to be used Instructions about using a calibrated marker and not geo metrically deformed have to be clearly specified by the inte grator to the user For single use markers the end user manual must clearly state that the markers should not be reprocessed The markers packaging must be marked with a label indicating they cannot be reprocessed For single use fiducials ins...

Страница 107: ... the active marker undergoes a sterilisation procedure The batteries used in active markers must comply with the regulation standards Battery for active markers must be sterile The integrator has to indicate in the end user manual to use only sterilized batteries according to ISO 14937 Any electric defects on active markers such as explosion leakage overheating might lead to operator or patient in...

Страница 108: ... other hazards The integrator should use redundant fiducials i e four or more fiducials instead of only three and require the recon structed marker to use all of them The default parameters have been chosen to ensure optimal tracking performances Changing them might impact the performances of the fusionTrack system The fusionTrack device must be cleaned as described in Chapter 17 The certification...

Страница 109: ...e inte grator shall state in their user manual that no objects in the field of view are allowed but the markers pointers or surgical tools A large registration error can be caused by a scratched fidu cial liquids on fiducial damaged fiducial wrongly fixed fidu cials on the marker or a deformed marker The integrator must generate an error message when the marker registra tion error is too high The ...

Страница 110: ...ny perturbation The integrator is suggested to periodically check the camera pictures The fusionTrack is not intended to be sterilised An initial level of contamination could lead to patient contamination The cameras have to be placed outside of the sterile field and cleaned after every single use Methods of cleaning are indicated in Chapter 17 The integrator must check that the fusionTrack device...

Страница 111: ... Unordered packets may affect the performances of the fusionTrack Received data from fusionTrack device might be delayed or the latency might be inconsistent the clock synchronization procedure as described in Section 8 4 must be performed by the integrator to ensure that the fusionTrack device and software running on the host computer are correctly syn chronized A software dysfunction due to unav...

Страница 112: ... the fusionTrack adjacent to or stacked with other equipment should be avoided because it could result in im proper operation and can lead to wrong measurements to serious injury including death If such use is necessary the fusionTrack and the other equipment should be observed to verify that they are operating normally Use of accessories transducers and cables other than those specified or provid...

Страница 113: ...er manual Version v4 5 2 The end user manual instruction shall provide a validated cleaning and disinfection method to the end user The integrator must ensure markers are not deformed after sterilisation ...

Страница 114: ...n 2 http en wikipedia org wiki INI_file 2014 Online accessed 2015 01 13 3 Roger M Needham David J Wheeler Tea extension tech rep Computer Laboratory University of Cambridge 1997 4 A F Möbius Der barycentrische Calcül ein neues Hilfsmittel zur analytischen Behandlung der Geome trie 1827 ...

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