Supersonic AixplorerUltimate User manual
















  
    
 
   
   
  
   

   
  
   
    
 
  
  

 


   

   
™™ 
™
™  
   
 


   

 

 


   
 

 
 
™™™
   

   
 
   
  
   
   


   
 
™   
™   
™ 
 
   
    

   
   

  

  


 
 
 
  
 
 

 
™
   

 
   

   
 
 
   
 
 
  
 

 
 
  

 

™

™
™
 

   

   
 

   
 

  
 

 


 

 


The following documents are available for the Aixplorer® Ultimate
Ultrasound System:
•Quick Guide
•User's Guide
•Fusion/Navigation Guide
The Quick Guide contains basic information regarding the use of the
product.
It does not replace the User's Guide.
The User's Guide contains important information regarding the use and
safety of the product. Please read this guide carefully and store it in a
location where it can be easily accessed.
This Fusion/Navigation Guide contains important information regarding
the use and safety of the Fusion/Navigation feature.
The Aixplorer® Ultimate system has been designed 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 intended to support a clinical ultrasound
exam and follow percutaneous procedures by means of providing
additional real-time image information from a 2nd modality like CT,
MR, PET or 3D US or their combination, with the possibility to plan
ideal treatment procedure. The second modality is imported and then
synchronized with the live US image, permitting the live correlation with
the patient position.
 

The 2nd modality image is not intended to be used as a standalone
diagnostic image since it represents information of a patient probably
not congruent with the current (real) patient situation and shall therefore
always be seen as an additional source of information.

The user must be a physician able to perform a biopsy, navigate into MRI
or CT scanner volumes, and manipulate ultrasound devices.
3 packages are available for the Fusion/Navigation feature:
Package Name Components
Fusion -Full Data Import module
-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 Import module
-Target module with Risk
Organs/ Safety Margins
-Registration module
-Navigation module
-Virtual Mode module (eTRAX™,
VirtuTRAX™ and US target definition)
-Motion tracking (detection
and correction) breathing
detection with omniTRAX™
* does not allow import of external data, only 3D US scans.
** for 3D US scans only.
 


This Fusion/Navigation guide contains important information about the
use and safety of the fusion feature of Aixplorer® Ultimate.
Please contact your local SuperSonic Imagine sales or service
representative for further information.
Pictures are not contractual and are only displayed for general
information purposes.
It also contains information about contacting SuperSonic Imagine for
support.
This guide is intended for use by, or by the order of, and under direct
supervision of a licensed physician qualified 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/EEC European
Directive
• FDA regulation, 21 CFR § 801

In case further information is needed, trainings are advised and
available upon request at SuperSonic Imagine. Please contact your local
representative for more information.

Customer service representatives are available regionally to help answer
your questions.
 

Please contact your local SuperSonic Imagine sales or service
representative for assistance.

SuperSonic Imagine
Les Jardins de la Duranne - Bât E & F
510, rue René Descartes
13857 Aix en Provence Cedex - France
Telephone: [phone]
Telephone: [phone]
Fax: [phone]
E-mail: [email protected]

SuperSonic Imagine, Inc.
2625 Weston Road
Weston, FL 33331- North America
Telephone: [phone]
E-mail: [email protected]

SuperSonic Imagine Ltd.,
18 Upper Walk
Virginia Water
Surrey GU25 4SN - United Kingdom
Telephone: [phone]
E-mail: [email protected]
 


SuperSonic Imagine GmbH
Zeppelinstr. 71 – 73
81669 München - Germany
Phone: [phone] - 844
Fax: + 49 89 36036 - 700
E-mail: [email protected]

SuperSonic Imagine
Suite 2304, Block D, Ocean International, DongSiHuan ZhongLu,
Chaoyang District, Beijing (100025), China
Phone : [phone]
Fax: + 86-10-8586 2389
E-mail: [email protected]

Call your SuperSonic Imagine local representative.
 

 


 

 



a WARNING symbol describes precautions necessary to prevent injury
or loss of life.

a CAUTION symbol describes precautions necessary to protect the
equipment.

A diagnosis can not be only based on the results of the Fusion/Navigation
feature. In particular the displayed image 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.

The operational electromagnetic field (ovoid shape) is minimum 20cm,
maximum 80 cm in front of the transmitter, 66cm for a good accuracy,
+/-30cm above and below, +/- 28cm on the sides.
 

Avoid metallic objects that include steel or iron between the tracking
transmitter and receiver since they may affect the accuracy of the tracking
device. If in doubt, please contact your technical support.
Don't put the transmitter too close to walls containing metallic
components, it could affect the accuracy of the tracking.
Patients with cardiac pacemakers shall not be treated with the Fusion/
Navigation feature.
During and after the registration, do not move the transmitter nor the
patient during the following session. For each session or in the event of
a patient shift or transmitter movement, the 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 tool
but must not be used without considering the real-time ultrasound biopsy
line display. In particular it should not be considered during percutaneous
procedures as it may not reflect the real-time situation.
The Virtual Needle length is defined by the distance between the sensor
and the needle tip. Calibrate the needle to acquire the right length or enter
it manually. The measure is considered in cm.
 

If the difference between the input and the measured distance is more than
5mm, the virtual needle may not be displayed properly and the procedure
can be a risk for the patient.
The Virtual Needle displayed may not be congruent with the real needle
position. Verify with Ultrasound or any other imaging modality useful to
assess the real needle position. Do not perform any invasive procedure
before the proper assessment of the needle tool.
When using the VirtuTRAX sensor the accuracy is sensitive to needle
bending. Do not use needle with Gauge more than 16GA and only use
rigid needle.
The accuracy of the system could be affected by tolerance existing in the
VirtuTRAX plastic holder, or a slight shift of the needle tip during the
calibration procedure. Before starting any procedure, always verify the
reliability of your VirtuTRAX device by means of the dedicated accuracy
verification procedure (See Chapter 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 with a dedicated product before and after use.
The accuracy of the breathing sensor depends on the position where it is
attached to the patient.
Please verify the breathing in and breathing out positions after sensor
calibration.
The omniTRAX™ needs to be placed on the patient skin before the CT
scan or MR and patient movements after its placement can lead to a
misalignment of the holder and consequently registration error.
When the breathing sensor is activated with the motion a constant time is
needed to discern the movement due to the breathing to the one for the real
patient movement. During this time (s) the accuracy could be degraded.
Do not base diagnosis on exported recorded clip or images only.
 

The interpolation process between the slices could modify the anatomical
structure between them. Please verify the morphology before using it.
The Navigation accuracy in optimal condition can be affected by
registration error, patient breathing and sensor support tolerance, EM
interference ...
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 Meaning
Type B
Type CF
Manufacturer
only Physician Only
Unsafe for MR
No Pacemaker
 