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Supersonic AixplorerUltimate, User Manual

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The  Fusion/Navigation  feature  is  to  be  used  with  the  following
components:

• driveBAY (3D Guidance driveBAY Electronics Unit, sensor and mid-

range transmitter)

• omniTRAX™ (optional)
• VirtuTRAX™ (optional)
• eTRAX™ (optional)
• Transmitter cart (optional) SSIP92922-A03

Only the following components may be connected to the driveBAY:

Component

Manufacturer

Reference

Transducer sensor

NDI

600786

General Purpose

Electromagnetic Sensor

CIVCO

610-1066

eTRAX™

CIVCO

610-1055

3DG trackSTAR Mid-

Range Transmitter

NDI

600222-H

#*

%++&# 

This table compiles information related to the electrical protection of the
devices used for the Fusion/Navigation feature.

Component

Manufacturer

Classification

IP Code

eTRAX™

CIVCO

CF Applied Part

IPX 7

General purpose

sensor for

VirtuTRAX™

and omniTRAX™

CIVCO

B Applied Part

IPX0

@'-A

$#

Summary of Contents for AixplorerUltimate

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Page 3: ... 3 B 3 9 9 9 B 3 B B 0 1 1 B 2 1 3 4 9 1 3 4 C 3 5 6 0 B 5 6 0 9 0 1 A ...

Page 4: ... 20 D 7 7 9 8 7 B 1 8 2 1 1 3 4 B 3 3 3 3 1 9 B BB B9 2 B9 3 B BC 1 BC 2 1 9 1 9 9 99 4 2 9C 2 5 6 6 2 B 2 7 C A ...

Page 5: ... 7 C 1 CB 8 BD 7 9 B 7 4 B B B B3 B C C C BB D 7 D 7 7 4 7 D 9 D3 7 B 5 7 B D D DB A ...

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Page 9: ...d with the safety of the operator and patient in mind The Fusion Navigation feature has been developed in collaboration with MedCom GmbH Please read the following chapters thoroughly before you start working with the system SuperSonic Imagine guarantees the system will perform as intended only when all cautions and warnings specified in this user s guide are observed Fusion Navigation is a feature...

Page 10: ...le Target module with Risk Organs Safety Margins Registration module Motion tracking detection and correction breathing detection with omniTRAX Volume Navigation and Needle Guidance Data Import Virtual Mode eTRAX VirtuTRAX and US target definition Motion tracking detection and correction breathing detection with omniTRAX Navigation module Fusion Volume Navigation and Needle Guidance Full Data Impo...

Page 11: ...to direct the use of the ultrasound device This guide is intended for users who have been trained or are otherwise familiar with the use of medical ultrasound devices and the Fusion Navigation feature Clinical guidance on how to perform an ultrasound examination is not provided in this manual This Fusion Navigation guide complies with the following 93 42 EEC European Directive modified by 2007 47 ...

Page 12: ...ephone 33 0 442 99 24 32 Telephone 33 0 426 70 02 70 Fax 33 0 442 52 59 21 E mail contactsFR supersonicimagine com SuperSonic Imagine Inc 2625 Weston Road Weston FL 33331 North America Telephone 1 954 660 3528 E mail contactsUSA supersonicimagine com A SuperSonic Imagine Ltd 18 Upper Walk Virginia Water Surrey GU25 4SN United Kingdom Telephone 44 0 845 643 4516 E mail contactsUK supersonicimagine ...

Page 13: ...36 700 E mail contactsDE supersonicimagine com SuperSonic Imagine Suite 2304 Block D Ocean International DongSiHuan ZhongLu Chaoyang District Beijing 100025 China Phone 86 10 85861023 2951 2917 Fax 86 10 8586 2389 E mail beijing supersonicimagine com Call your SuperSonic Imagine local representative A ...

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Page 17: ... of the 2nd modality shall never be used as a standalone source for assessments since it represents computed and thus artificial information SuperSonic Imagine is not engaging any responsibility for indirect harm due to the use and evaluation of diagnosis data furnished by the Fusion Navigation feature 7 The operational electromagnetic field ovoid shape is minimum 20cm maximum 80 cm in front of th...

Page 18: ... registration procedure has to be repeated unless movement correction is activated through the use of omniTRAX CT or MR When one of the the needle guidance tools VirtuTRAX or eTRAX is enabled on the Ultrasound device while in Navigation or Virtual Mode it displays a corresponding virtual biopsy line in the 2nd modality image These guidelines are intended to be used as an additional orientation too...

Page 19: ...apter 6 Settings 97 The accuracy of the system could be affected by an incorrect assembling of the eTRAX needle or a damaged eTRAX device Before starting any procedure always verify the reliability of your eTRAX device by mean of the dedicated accuracy verification procedure See Chapter 6 Settings 97 Use a sterilized sheath to cover the holder and the receiver before lock to the needle Clean it wi...

Page 20: ...nce When loading 3D DICOM dataset please be aware that the Fusion Navigation feature is not able to handle non equivalent distant acquisitions as well as 3D datasets that have been acquired while a gantry tilt was applied The following symbols are used for the Fusion Navigation feature only Please refer to the Aixplorer Ultimate User s Guide for all symbols regarding the Aixplorer Ultimate Symbol ...

Page 21: ...in Take the Needle and do a pivot movement and rotation Keep needle tip in fixed position Be aware that the error of the displayed needle position increases proportionally to the needle length Needle calibration failure VirtuTRAX Calibration failed Needle Tip probably changed position during movement Keep needle tip in fixed position for calibration Calibration failed The needle is placed in the w...

Page 22: ...ow on do not move patient nor transmitter 3D Ultrasound acquisition Please start an examination before US acquisition Memory error 3D acquisition requires more memory than is available Please contact a SuperSonic Imagine representative Try to change acquisition parameters Needle navigation with defined risk organs RISK organ in the way Import of secondary modality The patient name does not match t...

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Page 25: ...nected to the driveBAY Component Manufacturer Reference Transducer sensor NDI 600786 General Purpose Electromagnetic Sensor CIVCO 610 1066 eTRAX CIVCO 610 1055 3DG trackSTAR Mid Range Transmitter NDI 600222 H This table compiles information related to the electrical protection of the devices used for the Fusion Navigation feature Component Manufacturer Classification IP Code eTRAX CIVCO CF Applied...

Page 26: ... NDI Class I IPX0 Transducer Sensor NDI Class I B Applied Part IPX0 This section describes which part of each device may be in contact with the patient during an exam or an interventional procedure these parts are highlighted in orange on the pictures below eTRAX Sheath eTRAX Stylet VirtuTRAX A ...

Page 27: ...General Purpose Sensor omniTRAX CT omniTRAX MR A ...

Page 28: ... operating range of its transmitter Tracking data is reported serially to your host computer via a USB interface Make sure you have the following components before using the driveBAY tracker 3D Guidance driveBAY Electronics Unit Check the driveBAY LED status before use LED Definition of the 3D Guidance Electronic Units LED State Description of board status Possible Error Conditions resulting in LE...

Page 29: ...T BLINKING RED 2Hz MDSP DSP code downloaded by POSERVER MDSP failed to respond to messages MDSP code corrupt MDSP error Board error SLOW BLINKING ORANGE 1Hz POSERVER successfully communicated with MDSP SYSTEM EEProm error PLD version error MDSP fails to respond after tests MDSP test failed FAST BLINKING ORANGE 2Hz All of POSERVER initialization and power on test is complete Transmitter not present...

Page 30: ...ostics has failed Primary suspect is a removed transmitter This shows up as a TX Temp Sense error Secondary suspects might be TX Temp Sense or EU Temp Sense over heating problem A Transducer sensor Model 800 2 These clips are to be used to attach the sensor cable to the transducer cable Twist the clip as shown below to firmly attach the cables Mid Range Transmitter A ...

Page 31: ...gy this device allows physicians to quickly and accurately register patient anatomy eliminating a tedious manual image registration When placed on the sternum or any solids parts of the body such as ribs omniTRAX can be used to synchronise images for viewing the needle path with a moving target omniTRAX features multiple fixed reference points visible under CT and ultrasound in an accurate three d...

Page 32: ...e sensor during image fusion adjusting with small patient movements such as breathing omniTRAX is designed for single patient use and is sold non sterile The durable sensor is part of a Class B device The device may be cleaned high level disinfected or sterilized according to instructions for use The omniTRAX device is also compatible with MR the MR dedicated omniTRAX device is shown above 4 7 5 6...

Page 33: ...systems with navigation technology this device allows physicians to more precisely track the tip of any rigid instrument such as biopsy needles as it is being directed to a targeted anatomical area In the case of ultrasound the instruments is inserted into the patient and the tip location is displayed in real time on the ultrasound screen 7 The Aixplorer Ultimate is an imaging device For intervent...

Page 34: ...When integrated with visualization tools eTRAX enables accurate percutaneous targeting of lesions without radiation or open surgery This two part coaxial system consists of a reusable non sterile needle handle with a 1 3mm sensor in the distal tip and a sterile disposable needle with a trocar tip A sterile CIV Flex cover is used to easily cover the reusable handle prior to insertion into the dispo...

Page 35: ...positioning in the clinical environment The durable sensor is part of a Class CF device The device may be cleaned or disinfected according to instructions for use 4 eTRAX models are compatible with the Aixplorer Ultimate 12GA 14GA 16GA and 18GA The list of compatible needles is available at http www civco com Note that the maximum operational range of the eTRAX device is 35cm from the transmitter ...

Page 36: ...r more information about the operational electromagnetic field of the transmitter You must mount the transmitter on the cart for more information please refer to the section called Setting Up the Transmitter on the Cart 37 Don t put the cart with the transmitter too close to walls containing metallic components it could affect the accuracy of the tracking 7 Remove transmitter during cart transport...

Page 37: ... 3D endo probe SEV12 3 the transmitter needs to be placed behind the probe handle to maximize the sensor detection Move the cart using the handle Use the braking system on two wheels to lock the system in position A ...

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Page 41: ...weighs 2 6kg 5 73lbs Grasp it firmly before moving it 4 Set up the transmitter in a non magnetic location such as wood or plastic but never on the floor preferably on the optional transmitter cart Try to keep at least a 61cm 24 inch radius around the transmitter free from any magnetic object or electrical wiring which means keeping the transmitter at least that distance away from the Aixplorer Ult...

Page 42: ... omniTRAX to the connector marked 4 Do not put the transmitter or the sensor near metallic objects Always connect the sensors and the transmitter to the driveBAY when the Aixplorer Ultimate is off 0 1 Since the driveBAY is connected to the Aixplorer Ultimate power supply the driveBAY starts up when you turn on the Aixplorer Ultimate The indicator light on the front of the drive BAY slowly blinks w...

Page 43: ...nd double check all the cable connections Make sure all the cables are fully seated in their plugs Then turn it back on Once the patient is ready for the exam position the transmitter on a stable non magnetic support on the side and slightly over the patient so that the anatomy of interest is within the operational electromagnetic field Don t put the transmitter too close to walls containing metal...

Page 44: ...Then place the transmitter clamp on the plate as follows C A ...

Page 45: ...Make sure the clamp is well mounted on the plate as shown below A ...

Page 46: ...ighten the screws in the dedicated holes 20 This section indicates the steps to follow to properly prepare the probe for the exams as well as how to position the omniTRAX VirtuTRAX and eTRAX devices if needed A ...

Page 47: ...e Chapter 7 System Care Maintenance 101 If the bracket does not fit properly do not use it Once mounted do not use the bracket if it is rotating or moving on the probe Or if the sensor is rotating or moving on the bracket Please verify periodically that the bracket is not damaged and fits the probe properly without moving A ...

Page 48: ...cket in the correct position on the probe as follows For the XC6 1 When mounting the bracket on the transducer make sure the arrows on the side of both the bracket and the transducer are aligned see picture below A ...

Page 49: ... For the SL10 2 When mounting the bracket on the transducer make sure the arrows on the side of both the bracket and the transducer are aligned see picture below A ...

Page 50: ... For the SE12 3 The clamp of the SE12 3 bracket has to be placed on the side of the thumb dedicated area of the probe see picture below A ...

Page 51: ... For the SEV12 3 The clamp of the SEV12 3 bracket has to be placed on the side of the thumb dedicated area of the probe see picture below A B ...

Page 52: ...y attached failure to do so could result in inaccuracy 7 Do not use if the sensor fell down Attach the sensor to the bracket by putting the sensor side with the small notch see picture below on the sensor mount area of the bracket 9 A ...

Page 53: ...taching the sensor the side with the small notch has to be placed against the probe see picture below Make sure the sensor is firmly attached For the XC6 1 Mount the sensor on the dedicated area as shown above A ...

Page 54: ... For the SL10 2 Mount the sensor on the dedicated area as shown above For the SE12 3 The sensor mount area is located in the bracket as shown above C A ...

Page 55: ...therefore always put the sensor on the bracket before attaching the bracket to the transducer For the SE12 3 make sure to push the sensor so that it touches the bottom of the dedicated groove 7 Clean and disinfect sterilize before usage and between each patient according the recommendations in the Chapter 7 System Care Maintenance 101 A ...

Page 56: ...lize single use device Reuse reprocessing or resterilization may create a risk of contamination of the device cause patient infection or cross infection 1 Place an appropriate amount of gel inside the sheath and or the transducer face Poor imaging may result if no gel is used 2 Insert the transducer into the sheath making sure to use proper sterile technique Pull the sheath tightly of the transduc...

Page 57: ...3 A B ...

Page 58: ...B A ...

Page 59: ...combined to compute a virtual slice image that is spatially comparable to the currently displayed ultrasound scan 7 Fusion performance can be impacted by organ deformation due to application of excessive pressure of the transducer on the patient s body patient s breathing or different patient position during the 2nd modality exam Before the system is able to compute the 2nd modality image correctl...

Page 60: ...xplorer Ultimate User s Guide For more details about how to use the Fusion Navigation feature please refer to the following sections in this chapter The probes compatible with the Fusion Navigation feature are the following XC6 1 SL10 2 SE12 3 SEV12 3 7 Never re use a sheath intended for invasive use The following list indicates the sheaths compatible with the probes Transducer width 7 89 cm 3 11 ...

Page 61: ...Flex Flat Folded 3D 610 362 14 x 61cm Protek Sterile Latex Free PullUp Probe Cover Kit 2097 14 x 121 9cm Ecolab Microtek Sterile Latex Free PullUp Probe Cover with gel PC1292EU 15 x 244cm 8 D Transducer width 5 92 cm 2 33 in cable length 2 1 m 82 7 in Manufacturer Sterility Latex Latex Free Description Product Number Dimensions CIVCO Sterile Latex Free CIV Flex Flat Folded 610 323 6 x 91 5cm CIVCO...

Page 62: ... 610 844 4 x 30cm CIVCO Non sterile Latex Free NeoGuard Rolled 610 838 4 x 30cm CIVCO Non Sterile Latex Free Eclipse Polyethylene cover with gel 610 1102 8 4 tapered to 4 3 x 24 1cm CIVCO Non Sterile Latex Free Eclipse Polyethylene cover with gel 610 792 6 1 tapered to 4 6 x 24 1cm CG Medical Sterile Latex PR STC080316 8 x 30cm 24 Transducer width at tip 2 47 cm 0 97 in transducer maximum width at...

Page 63: ...d 610 844 4 x 30cm CIVCO Non sterile Latex Free NeoGuard Rolled 610 838 4 x 30cm CIVCO Non Sterile Latex Free Eclipse Polyethylene cover with gel 610 1102 8 4 tapered to 4 3 x 24 1cm CIVCO Non Sterile Latex Free Eclipse Polyethylene cover with gel 610 792 6 1 tapered to 4 6 x 24 1cm Manufacturer Sterility Latex Latex Free Description Product Number Dimensions Vygon Sterile Latex Free 39 00 09 100 ...

Page 64: ... 7 Manufacturer Sterility Latex Latex Free Description Product Number Dimensions CIVCO Sterile Latex Free CIV Flex 610 1207 10 12GA x 7cm with 7 6 tapered to 3 8 x 147cm CIVCO Sterile Latex Free CIV Flex 610 1209 10 12GA x 9cm with 7 6 tapered to 3 8 x 147cm CIVCO Sterile Latex Free CIV Flex 610 1211 10 12GA x 11cm with BC A ...

Page 65: ...y Latex Latex Free Description Product Number Dimensions CIVCO Sterile Latex Free CIV Flex 610 1407 10 14GA x 7cm with 7 6 tapered to 3 8 x 147cm CIVCO Sterile Latex Free CIV Flex 610 1409 10 14GA x 9cm with 7 6 tapered to 3 8 x 147cm CIVCO Sterile Latex Free CIV Flex 610 1411 10 14GA x 11cm with 7 6 tapered to 3 8 x 147cm CIVCO Sterile Latex Free CIV Flex 610 1413 10 14GA x 13cm with 7 6 tapered ...

Page 66: ...tapered to 3 8 x 147cm CIVCO Sterile Latex Free CIV Flex 610 1613 10 16GA x 13cm with 7 6 tapered to 3 8 x 147cm CIVCO Sterile Latex Free CIV Flex 610 1615 10 16GA x 15cm with 7 6 tapered to 3 8 x 147cm CIVCO Sterile Latex Free CIV Flex 610 1057 16GA x 17cm and 7 6 tapered to 3 8 x 147cm Manufacturer Sterility Latex Latex Free Description Product Number Dimensions CIVCO Sterile Latex Free CIV Flex...

Page 67: ... 610 1813 10 18GA x 13cm with 7 6 tapered to 3 8x 147cm CIVCO Sterile Latex Free CIV Flex 610 1815 10 18GA x 15cm with 7 6 tapered to 3 8 x 147cm CIVCO Sterile Latex Free CIV Flex 610 1818 10 18GA x 18cm with 7 6 tapered to 3 8 x 147cm 4 7 Manufacturer Sterility Latex Latex Free Description Product Number Dimensions CIVCO Sterile Latex Free CIV Flex Telescopically folded 610 1059 10 17GA with 8 9 ...

Page 68: ...n t move between exams Manufacturer Sterility Latex Latex Free Description Product Number Dimensions 3M Sterile Latex Free Transparent Film Dressing Frame Style 1626W 10 x 12 cm 1 Ultrasound image 2 2nd modality volume 3 Thumbnails of 2nd modality views 4 Control interface 5 Menu with main modules 6 Layouts icons 9 A ...

Page 69: ...tings 97 for more details about the Settings Data Management See the section called Data Import optional 72 for more details about Data Management Virtual Mode See the section called Virtual Mode 68 for more details about Virtual Mode Targets Allows to define targets or Risk Areas on the 2nd Modality dataset A dedicated Target List menu is also available in the Virtual Mode to define targets on th...

Page 70: ...asound image or the full Aixplorer ultrasound area Flip Left Right Pressing this button allows you to switch the selected plane from left to right or the opposite Flip Top Bottom Pressing this button allows you to switch the selected plane from top to bottom or the opposite Layouts Pressing one of these buttons changes the display format of the on screen information Full screen view Click on this ...

Page 71: ...bout this layout Needle reference view See the section called Needle Reference View 92 for more details about Needle reference view 2 3 1 3 and 4 thumbnails 2 3 1 3 Side by side Side by side and 4 thumbnails 6 view comparison layout between two imported modalities See the section called Comparing Two 2nd Modality Volumes 75 for more details about the 6 view comparison layout A 9B ...

Page 72: ...the intersection cross you can adjust the display as needed See the section called Comparing Two 2nd Modality Volumes 75 for more details about Matching View 9 7 This area shows you in real time the function of the Trackball TouchRing PW button and Select Depending on the context you can use these buttons to modify settings When you can use one of these buttons it is highlighted in orange and its ...

Page 73: ...n the sensor and the transmitter as close as possible to guarantee accurate results and ensure that the quality signal is green The red TissueTuner marker appears when the TissueTuner currently used is not the same as the one used during the factory calibration Always use the 1540 m s TissueTuner value when in Fusion Navigation This area allows you to visualize in real time the various planes of t...

Page 74: ...terventional procedure The Virtual mode allows you to define up to 7 biopsy targets or Risk Areas 1 Click on New US Target A virtual target is displayed on both sides 2 Move the Trackball to position the target 3 Use the TouchRing or PW knob to resize the target the diameter value is displayed in live 4 Press Select to validate the target The target appears on the list 9C A ...

Page 75: ...ange the color of the target 6 Check the Risk checkbox to change the target into a Risk area You can define a security margin around this risk area from 5 mm to 15 mm When a risk area is defined you will receive a warning message if the needle path crosses it 7 9 1 Select the target or risk area you want to delete 2 Click on Delete A 9 ...

Page 76: ...hey are correctly connected click on either eTRAX On Off or VirtuTRAX On Off to activate one of the devices 2 There are 2 methods for the VirtuTRAX calibration in the Settings Menu under Other Settings tab Manual method A popup window will appear asking you to manually enter the needle distance which is the distance between the needle tip and the bottom part of the needle holder Pivot method Do a ...

Page 77: ... is correctly connected configured and well positioned on the patient It allows to monitor the patient breathing and ensure the breathing level is the same as the one used during the CT or MR acquisition Movement Correction will automatically correct the referential as a function of patient s movement if the omniTRAX is correctly connected configured and well positioned on the patient Movement Det...

Page 78: ... scanning plane but still parallel to it the needle path is displayed as a solid grey line When the needle path is not parallel to the scanning plane but crossing it the needle path is displayed as a dotted blue line with a circle showing the intersection between the needle path and the scanning plane and the distance from the needle tip to the circle 5 6 Data Import This section allows you to imp...

Page 79: ...yed 2 Enter your patient information 3 Use search criteria as needed Press Query 4 Select the appropriate exam to retrieve Press Retrieve 5 When Retrieved Pushed or Imported highlighted in green appears press Send to fusion A ...

Page 80: ...orted exams from a media To import DICOM data from a USB media or the CD DVD press Import from Media A window will appear allowing you to import either a DICOM DIR file or a Folder containing the DICOM data to be imported 6 Click on the black and white vertical bar to adjust the DICOM contrast and brightness A ...

Page 81: ...ast profiles for each modality Press Remove to remove a volume or press Remove All to remove all the volumes 4 When at least two volumes have been imported you can display the 2 modalities and compare them using the 6 view comparison layout icon The 3 MPR views of each volume will then be compared in a top bottom display Select which modalities you want to compare under the primary volume and seco...

Page 82: ...l Fusion bar You can then use either the TouchRing or PW to adjust the fusion blending control In addition you can press the Matching icon to display in diagonal the 2 modalities and then use the pointer and Select button to focus on an area of interest to be displayed with the 2 modalities and see how they match 9 A ...

Page 83: ...modality This feature is available is B mode SWE CFI CPI dCPI Angio PL U S RT CEUS and TriVu 1 Click on the 3D button The system is in live ultrasound imaging 2 Put the probe on the first plane of the volume you want to acquire 3 Click on Start acquisition A ...

Page 84: ... Click on Stop acquisition or wait until the progress bar is complete 6 Once done the system automatically switches to the Navigation mode with the 3D ultrasound acquisition on the right 2 Please note that the 3D volume rendering is always displayed in black and white C A ...

Page 85: ...pability to use the motorized 3D acquisition This feature is only available in B mode 1 You can launch a 3D acquisition using the 3D Acquisition button on the Touch screen 2 This can be done either from the Data Import menu or from the Virtual Mode menu when SEV12 3 is used A ...

Page 86: ...e within the 3D US volume acquired 7 When using the 3D endo probe SEV12 3 the transmitter needs to be placed behind the probe handle to maximize the sensor detection After a registration the tilting of the transducer needs to be limited in order to minimize registration accuracy errors C A ...

Page 87: ... has not been used and the movement correction is not activated The registered slice of the 3D volume from the 2nd modality appears on the right side of the screen The live ultrasound image appears on the left side of the screen 7 1 Click on the One Plane tab of the Registration module and select the plane of interest in the 2nd modality 3D volume Use the thumbnails at the bottom of the screen to ...

Page 88: ...lane When the registration has been performed the transmitter will track the probe movement as well as the patient movement through the omniTRAX patient tracker if it has been used The system will display the ultrasound live image and the registered slice from the 2nd modality in a side by side manner including overlapping between the two images Fusion Blending control C A ...

Page 89: ... be registered on the 2nd modality The live Ultrasound image is now perfectly synchronized with the 2nd Modality on a specific anatomical point When you want to register more than one internal marker go to the Internal Markers Registration section Use the TouchRing or PW to change the priority between the ultrasound image and the 2nd modality Fusion blending control 7 After registration and partic...

Page 90: ...to find the 2nd modality slice with the same anatomical point 5 Click on 2nd Modality under Record Position to freeze the image 6 Click on the anatomical point to be registered on the 2nd Modality Right side 7 Repeat this procedure from step 1 on at least 3 different anatomical points 8 Click on Register Markers The live Ultrasound image is now perfectly synchronized with the 2nd Modality based on...

Page 91: ...s of the omniTRAX markers seen on the 3D view make sure the auto detection of the omniTRAX markers in enabled 3 The 3 other points will be automatically detected and selected If the auto detection fails you can select the markers manually either on the 3D view or on one of the 3 MPR views which can be scrolled using the TouchRing or PW The Settings option Optimize marker position during click allo...

Page 92: ... select the 4 omniTRAX markers on the 3D volume You can start by clicking on the marker located at the top of the omniTRAX You can improve the omniTRAX registration in order to compensate the differences of patient anatomical conditions and positions between the CT or MR exam and the ultrasound exam 1 Click on the One Plane registration tab 2 Click on One Point to better match the live ultrasound ...

Page 93: ...lity image The live ultrasound image is now perfectly synchronized with the 2nd Modality on a specific anatomical point The Navigation Mode is the main application of Fusion Navigation providing additional real time image information from a 2nd modality side by side to the live ultrasound screen Additionally the virtually computed 2nd modality image might be overlapped on the current ultrasound si...

Page 94: ... comparison of the ultrasound live image vs the registered 2nd modality image using the PW or TouchRing Overlap controls to determine how well the two images match Please repeat the registration procedure if the ultrasound live image and the corresponding 2nd modality image appear to be poorly registered 8 After having successfully registered two different imported volume modalities with the live ...

Page 95: ...ce it on top of the main modality image you want to overlap over the two others and use the PW TouchRing as needed to adjust the overlapping This will be reflected on the upper right image with an associated percentage of display of each modality To get the focus on specific Aixplorer Ultimate mode controls management and arbitration such as color box size and position place the Pointer on top of ...

Page 96: ...mages match Please repeat the registration procedure if the ultrasound live image and one of the corresponding 2nd modality images appear to be poorly registered This section describes how to define targets for the 2nd modality only 2 types of targets may be defined see the section called Defining Ultrasound Targets 68 Interventional procedure targets Risk Areas The Target mode allows you to defin...

Page 97: ...st 2 Click on New a target is displayed on the 4 views 3 Move the Trackball to position the target 4 Use the TouchRing or PW knob to resize the target the diameter value is displayed in live 5 Press Select to validate the target The target appears on the list 2 You may hide each target as needed Uncheck the Show checkbox to hide the target Click on the colored square on the right menu to change th...

Page 98: ...sk areas at once by clicking on Delete All 7 4 This layout allows you while in Navigation with a 2nd Modality and with VirtuTRAX or eTRAX enabled to display the needle as a fixed reference within the 3 MPR views of the 2nd Modality At that time moving the needle or the treatment device will lead to a movement of the 3 MPR views to better center the target on the 3 MPR views and better guide the ne...

Page 99: ...Prospective Clip Save Time option settings from the main System Configuration menu of Aixplorer Ultimate which is managed by Ultrasound mode 2 Navigation Fusion images or clips cannot be reviewed in Full screen from the Review mode they can only be displayed in Review Image List as thumbnails All Navigation Fusion images or clips can be exported in DICOM format through the Network or through USB m...

Page 100: ...se be aware that the current patient breath state should be comparable to the one during the 2nd modality acquisition 7 Minimize patient motion or use omniTRAX However from the technical point of view an overlapping accuracy of at least 5mm can be achieved under the presumption that the registration has been done with an overall error better than 5mm 8 In the ultrasound image 5 error or better In ...

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Page 103: ...he right side of the screen to access the configuration menu The Settings menu is divided into 2 tabs System Accuracy Other Settings The system accuracy tab see picture above allows you to configure the sensor port assignments It is divided in 3 sub tabs Needle Calibration Test Sensor Port Assignment Sensor Positions A ...

Page 104: ...e transmitter is defective please contact your SuperSonic Imagine representative and if either the eTRAX or VirtuTRAX is defective please contact CIVCO or the reseller To perform the Needle Calibration Test please follow the instructions given on the screen in the Needle Calibration Test menu Sensor Port Assignment allows you to change the assignments of the sensor devices to the driveBAY ports Se...

Page 105: ...igure the way external data are imported either by Acquisition Tag or Series Number This option is available for each modality CT MR and PET This sub tab allows you to define the criteria based on which the imported data and the US exam will be compared The criteria are the following Patient Name Patient ID Date of Birth A ...

Page 106: ... also allows you to change the direction to which you should turn the PW TouchRing to increase the fusion blending between the US and the 2nd modality Clockwise Counter clockwise Finally you can change the calibration procedure of the VirtuTRAX Manual you must enter the length of the needle manually Pivot you must keep the needle in a fixed position and do a pivot movement A ...

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Page 109: ... the VirtuTRAX and omniTRAX devices The other accessories used for these devices are single use and therefore disposable 7 Users of this product have an obligation and responsibility to provide the highest degree of infection control to patients co workers and themselves To avoid cross contamination follow infection control policies established by your facility The recommended protocol for reproce...

Page 110: ...al purpose sensor from cleaning solution and remove any remaining residue with dry wipe Follow cleaning solution manufacturer s direction for use and recommendations for concentration High level disinfect general purpose sensor using CIDEX OPA ortho Phthaladehyde Solution Johnson Johnson or equivalent 55 ortho phthaladehyde based solution Follow manufacturer s instructions and recommendations for ...

Page 111: ...isually inspect the ENTIRE device is clean and no visible things remain Flush with the high level disinfectant to ensure that the disinfectant reaches all areas Always use sterile water for rinsing or removing residual germicides from devices Do not rinse reprocessed devices with tap water which may recontaminate the device Thoroughly dry the device after rinsing Always use a probe cover to minimi...

Page 112: ...acy Periodically clean the equipment electronics unit transmitter sensor and cables by wiping down with a cloth dampened in a cleaning solution such as mild soap and water isopropyl alcohol or a similar acceptable cleaning solution If the tracker s components come in contact with biological fluid or tissue be sure to follow your organization s procedures for proper cleaning and disinfection The el...

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Page 115: ...cation Check the suggestions outlined in Not able to communicate below Power up defaults did not change after configuring with the utility Configuration download interrupted driveBAY did not reset restart after burning the Flash settings Re start the driveBAY and the utility and set the defaults again Be sure to click APPLY to send the setting to the Electronics Cycle power to the driveBAY and re ...

Page 116: ... or Z position outputs suddenly change you may have crossed a hemisphere boundary Use the HEMISPHERE command to rectify Determine correct frequency 50 Hz in Europe 60 Hz in North America and set to correct value Poor accuracy Metal in tracking environment Damaged equipment Sensor or transmitter connector not properly inserted A software application error Board error Check all around the transmitte...

Page 117: ...erSonic Imagine S A Les Jardins de la Duranne Bât E et F 510 rue René Descartes F 13857 Aix en Provence Cedex France Telephone 33 0 442 99 24 32 Fax 33 0 442 52 59 21 Email contactsFR supersonicimagine fr ...

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