Antares Ultrasound Imaging System User and Reference Manuals Supplement, 5.0

Antares Ultrasound Imaging System
User and Reference Manuals Supplement, 5.0
S1 — General Information
S2 — Imaging Functions
S3 — Supplement to fourSight 4D Imaging and 3-Scape Imaging
S4 — syngo Velocity Vector Imaging
S5 — syngo Arterial Health Analysis Package
S6 — Transesophageal Transducer
S7 — Manuals Errata, 4.0

10038445-ABS-001-01-01
S ie me ns M edi cal Sol uti on s USA , In c . 10038445-01

Siemens Medical Solutions USA, Inc. CE Declaration
Ultrasound Division
1230 Shorebird Way
Mountain View, CA 94043-1344 This product is provided with a CE marking in
U.S.A. accordance with the regulations stated in
Council Directive 93/42/EEC of June 14, 1993
(800) 498-7948 concerning Medical Devices. Siemens Medical
(650) 969-9112 Solutions USA, Inc. is certified by Notified Body
0123 to Annex II.3 – Full Quality System.
©2007 Siemens Medical Solutions USA, Inc.
All Rights Reserved.
Authorized EC Representative:
March 2007 Siemens Aktiengesellschaft
Printed in the United States of America. Medical Solutions
Henkestraße 127
ACUSON Antares, SONOLINE Antares, D-91052 Erlangen
Advanced SieClear, Cadence, Dynamic TCE, Germany
eSie Touch, fourSight, SieClear, syngo, Velocity
Vector Imaging, and 3-Scape are trademarks or
registered trademarks of Siemens AG or its
subsidiaries and affiliates.
CIDEX, CIDEX Plus, CIDEX OPA, Milton, Virkon,
Gigasept FF, and STERRAD are trademarks of
their respective owners.
Siemens reserves the right to change system
specifications at any time.
ii U S E R A N D R E F E R E N C E M A N U A L S S U P P L E M E N T
General Information
Accessories and Options ................................................................................... 3
Transducers................................................................................................... 3
Phased Array .......................................................................................... 3
Transducer Accessories ......................................................................... 3
CD/DVD Combination Drive............................................................................... 3
Other Alphanumeric Keys ................................................................................. 4
Hide Text ....................................................................................................... 4
Text/Picto Group Box..................................................................................... 4
Anonymizing a Patient Study............................................................................ 5
Patient Security .................................................................................................. 6
Logging In to the Ultrasound System ............................................................ 6
Locking the Ultrasound System..................................................................... 7
Logging Off the Ultrasound System .............................................................. 7
Reference Section .............................................................................................. 8
Shortcut Buttons on the Image Screen ......................................................... 8
Disk Space Security Indicators ...................................................................... 8
U S E R A N D R E F E R E N C E M A N U A L S S U P P L E M E N T S1 - 1
General Information
S1 - 2 U S E R A N D R E F E R E N C E M A N U A L S S U P P L E M E N T
General Information
Accessories and Options

(Supplement to [1] Instructions for Use, Chapter 6, "Technical Description," and
System Reference, Chapter 1, "Acoustic Output Reference")
The following accessories and options require product version 5.0 or higher:
Advanced SieClear Spatial Compounding option (includes Dynamic
Tissue Contrast Enhancement (TCE) option)
syngo Velocity Vector Imaging option
syngo Arterial Health Package
Breast Imaging application (includes Elasticity Imaging option and
Fatty Tissue imaging option)
Advanced fourSight technology option
Amnioscopic Render Method option
syngo Auto OB option
DICOM Structured Report for Cardiac (included in the Cardiac
Application Module for software versions 5.0 or higher)
Transducers
Phased Array
V5M with micro-pinless adapter (requires the Cardiac Application
Module)
Transducer Accessories
Micro-pinless adapter (compatible with the V5M transducer)
CD/DVD Combination Drive

(Supplement to [1] Instructions for Use, Chapter 1, "Introduction," and Chapter 6,
"Technical Description")
Note: The DVD recordable media supported by the CD/DVD combination drive is DVD-R
or DVD-RW only. The CD/DVD combination drive does not support DVD+R or DVD+RW
formatted media.
General Information
Other Alphanumeric Keys

(Supplement to [1] Instructions for Use, Chapter 3, "System Controls")
Hide Text
Hides the Patient Banner on the screen. To redisplay the hidden Patient
Banner, press the Hide Text key again.
The green LED next to the key is illuminated when this function is enabled.
Text/Picto Group Box

Note: You can display the Text/Picto group box on the Calcs task card or on the Image
task card.
Selection Description Icon

Hide Words Hides all annotations, text cursor, and arrows on the ---
screen.
General Information
Anonymizing a Patient Study

(Supplement to [1] Instructions for Use, Chapter 5, "Beginning an Exam")
You can anonymize any completed patient study located in the local
database on the patient browser.
This will result in the removal of all information from the Patient Banner. The
system substitutes "Anonymous" in the place of the patient's name with a
new Patient ID. The Patient ID is generated from the date and time of the
anonymization.
Anonymized exams are automatically deleted from the ultrasound system

according to the automatic disk management settings in the system
presets.
To assign anonymity to an exam:

Select Anonymize from the Patient menu at the top of the patient
browser.
General Information
Patient Security
(Supplement to Antares User and Reference Manuals)
Important Note: Activating the security package on the ultrasound system requires a
Siemens service representative.
The security package on the ultrasound system protects patient information

from unauthorized access. It is the responsibility of the ultrasound system
administrator, someone located in your facility, to observe local security
polices and implement security settings and policies for the ultrasound
system.
The ultrasound system administrator also assigns permissions for each user
account. Permissions establish data access rights (either no access or full
access) that determine whether or not a user can view studies stored on the
system through the patient browser.
Logging In to the Ultrasound System

Once the security package is activated, all users are required to log in to the
ultrasound system prior to use.
To understand the permissions assigned to your user account, or if you do

not already have a user name and case-sensitive password, contact your
ultrasound system administrator.
To log in using your account:

On the login screen, use the alphanumeric keyboard to enter your
username and password and then select OK.
To log in as a different user:
1. Select the Security button at the bottom of the screen.
Security button.
2. Select Log in Different User.

3. Use the alphanumeric keyboard to enter your username and password
and then select OK.
General Information
Locking the Ultrasound System

Once the security package is activated, you can "lock" the system to prevent
unauthorized access to patient information.
Note: You can also lock the ultrasound system by activating the screen saver.
To lock the ultrasound system:

2. Select Lock Computer.
The system locks the system and displays the login screen.
Logging Off the Ultrasound System

You can log off the ultrasound system only after an exam is completed,
including data transfer.
To log off the ultrasound system:

2. Select Log Off <UserName> (where UserName is your username).
The system logs you out and displays the login screen.
General Information
Reference Section
Shortcut Buttons on the Image Screen
Icon Tooltip Function
Security Displays a dialog box for locking the ultrasound system, logging on or off the system,
and for changing the user password.
Note: This button displays only if the security package has been activated by your Siemens
service representative.
Disk Space Security Indicators

An icon displays on the lower right of the screen when you must contact
your administrator to archive the security audit logs.
Icon Function
Low disk space warning icon (yellow)
Indicates when the administrator must archive the ultrasound system's audit logs.
Failure to archive the audit logs will result in a loss of system functionality.
Full disk warning icon (red)
Indicates the system will be locked and no further actions may be taken on the system
until the audit logs are archived. If the full disk warning icon displays, contact the
ultrasound system administrator immediately.
Imaging Functions
Advanced SieClear Spatial Compounding Technology with
Dynamic TCE Capabilities.................................................................................. 3
Activating or Deactivating Advanced SieClear ............................................... 4
Changing Advanced SieClear Settings........................................................... 4
Changing Dynamic TCE Settings ................................................................... 4
Changing Tissue Stabilization Settings .......................................................... 4
Elasticity Imaging (EI) ........................................................................................ 5
Basic Measurements..................................................................................... 6
Fatty Tissue Imaging (FTI) ................................................................................. 7
Activating or Deactivating FTI ........................................................................ 7
syngo AutoOB Measurement ............................................................................ 8
Activating or Deactivating syngo AutoOB...................................................... 8
Imaging Functions
Imaging Functions
Advanced SieClear Spatial

Compounding Technology with
Dynamic TCE Capabilities
(Optional)
(Supplement to [2] Instructions for Use, Chapter 2, 2D-Mode and M-Mode
Imaging Functions)
Advanced SieClear Spatial Compounding is an optional 2-D image

optimization technique for enhanced viewing of tissue differences by
detection of subtle lesions and enhanced tissue differentiation.
Advanced SieClear applies up to 13 lines of sight at greater steering angles

to improve contrast resolution and border detection and to reduce speckle.
It produces images that have improved detail and contrast resolution,
improved visualization, and continuity of linear structures.
Advanced SieClear works in combination with Dynamic Tissue Contrast

Enhancement (TCE) and Tissue Stabilization to provide detail in complex
masses.
Dynamic Tissue Contrast Enhancement (TCE)
Dynamic TCE is a multi-scale adaptive image filter that relies on edge
diffusion and pyramidal processing to simultaneously achieve speckle
reduction and contrast enhancement, improving the coherence of
anatomical structures.
Dynamic TCE provides:
– Enhanced, realistic tissue presentation
– Patient-specific processing which adapts to differences in tissue
Tissue Stabilization
Tissue stabilization reduces the artifacts seen in compounded images,
thereby acting as an auto-focus for resolving the borders and edges of
heterogeneous structures.
In combination, these three imaging features provide images that enhance
continuity of linear structures and tissue boundaries, and maintain the
visibility of diagnostically-relevant acoustic shadowing and enhancement.
Note: Advanced SieClear maintains basic SieClear functionality when entering Color
Doppler, Color Power, PW Doppler, and M-mode.
Note: SieClear and Advanced SieClear are not available during Cadence Contrast Agent
Imaging.
See Also: [1] Instructions for Use, Chapter 6, Compatible Transducers.
Imaging Functions
Activating or Deactivating
Advanced SieClear
To activate Advanced SieClear:
1. Select Advanced SieClear from the 2D-mode Parameter menu.
2. Press the MENU control on the control panel to turn Advanced
SieClear on.
To deactivate Advanced SieClear:

2. Press the MENU control on the control panel to turn Advanced
SieClear off.
Changing Advanced SieClear Settings

To change the value for Advanced SieClear:
2. Rotate the MENU control on the control panel clockwise to increase the
setting or counterclockwise to decrease the setting.
Changing Dynamic TCE Settings

To change the value for Dynamic TCE:
1. Select Dynamic TCE from the 2D-mode Parameter menu.
2. Rotate the MENU control on the control panel clockwise to increase the
setting or counterclockwise to decrease the setting.
Changing Tissue Stabilization Settings

To turn Tissue Stabilization on or off:
1. Select Tissue Stabilize from the 2D-mode Parameter menu.
2. Press the MENU control on the control panel to turn Tissue
Stabilization on.
Press the MENU control on the control panel to turn Tissue
Stabilization off.
Imaging Functions
Elasticity Imaging (EI)

(Optional)
Imaging Functions)
Elasticity Imaging (EI) detects the relative stiffness of tissue during real-time
2D-mode imaging. Elasticity Imaging is a qualitative visualization method
that displays the relative stiffness of tissue as an elastogram. Elastograms
are generated during image acquisition by performing cycles of small,
manual compression during routine 2D-mode imaging. Images can be
displayed side-by-side with a standard 2D-mode image or full-screen.
See Also: [2] Instructions for Use, Chapter 1, Measurements and Calculations.
To activate Elasticity Imaging:

1. Press the 2D control on the control panel.
The Parameter menu lists 2D-mode menu selections, and the system
assigns control of the trackball to the pointer.
The Imaging group box displays 2D feature selections.
2. During image acquisition, access the Imaging group box and select the
EI button.
The system activates Elasticity Imaging and displays two images on the
screen in a live, dual format. The left image is a standard 2D-mode
image; the right image is represented by a gray, transparent region of
interest (ROI).
The active 2D-mode gray map is depicted by a gray bar, which displays
on the right side of the image screen. The gray bar represents the range
of gray shades available for the selected 2D-mode map. Directly above
the gray bar on the right side of the image screen is a second gray bar
for Elasticity Imaging. The EI bar represents the range of gray shades
available for depicting the stiffness of the tissue from SF (soft) to
HD (hard).
3. Use a cycle of gentle compressions to scan and generate the
elastogram, while avoiding lateral movement of the transducer.
Note: The natural compressions generated by a patient's respirations may be
sufficient during image acquisition for generating the elastogram.
4. If necessary, optimize the 2D-mode image using the 2D-mode menu

selections in the Parameter menu.
Imaging Functions
5. To optimize the size of the live, dual format on the screen, select
View Scale in the Imaging group box and adjust the setting from
50% to 100% in increments of 5.
Note: As you enlarge the image, the system "crops" the edges of the image while
maintaining the aspect ratio.
6. To toggle a standard gray scale map with an inverted gray scale map,
select Map Index and adjust the setting from 0 (normal, gray scale map)
to 2 (inverted gray scale map).
7. To apply a color map to the elastogram, select the Color Map button in
the Imaging group box.
Note: This selection is available during real-time imaging or on frozen images and
during CINE review.
The EI gray bar (above the 2D-mode gray bar) on the right side of the
image screen is replaced by a color bar. The color bar represents the
active color map available for depicting the stiffness of the tissue from
SF (soft) in purple to HD (hard) in red.
8. To display a full screen image, select the Elasticity Full button from the
Imaging group box. Select the Elasticity Dual button to reactivate the
side-by-side display.
9. To exit Elasticity Imaging, access the Imaging group box and press the
2D control on the control panel.
Basic Measurements
Basic measurements are available with Elasticity Imaging, including the
Area Ratio and Distance Ratio. You can perform all basic measurements
(distance, ellipse, and trace) on either dual screen.
See Also: [2] Instructions for Use, Chapter 1, Measurements and Calculations.
A "shadow" function is included with Elasticity Imaging. When the shadow

function is active, you can make a measurement on either the left image or
the right image. The system then duplicates and displays the measurement
on the other image.
To activate the shadow function during measurements with Elasticity

Imaging active:
1. During Elasticity Imaging, with the measurement function active, rotate
the MENU control on the control panel to highlight Shadow on the
Measurement menu, and then press the MENU control.
2. Measure a distance, trace, or ellipse on either image.
The system duplicates and displays the measurement on the other
image. The actual image measured contains the measurement markers
and the dotted line; the "shadow" image only contains the dotted line
(without the measurement markers).
3. To deactivate the "shadow" function, rotate the MENU control on the
control panel to highlight Shadow on the Measurement menu and then
press the MENU control.
Imaging Functions
Fatty Tissue Imaging (FTI)

Imaging Functions)
Fatty Tissue Imaging (FTI) provides enhanced 2D-mode image quality with
improved lateral and contrast resolution for ultrasound imaging of the fatty
breast tissue by allowing for a speed of sound correction during imaging.
Activating or Deactivating FTI

To activate FTI:
Select FTI from the 2D-mode Parameter menu.
To deactivate FTI:
1. Select FTI from the 2D-mode Parameter menu.
2. Press the MENU control on the control panel.
Imaging Functions
syngo AutoOB Measurement

(Optional)
(Supplement to [2] Instructions for Use, Chapter 3, Obstetric Measurements, Calculations,
and Reports)
Use the syngo AutoOB measurement method during an OB exam to

automatically measure fetal anatomy. The measurement labels available are:
Femur length (FL)
Abdominal circumference (AC)
Biparietal diameter (BPD)
Head circumference (HC)
Note: When you take a head circumference measurement, the occipital frontal
diameter (OFD) is automatically calculated and displayed on the right side of the
screen.
syngo AutoOB is automatically activated whenever you freeze an image

during an OB exam. The Auto button and its associated measurement label
buttons (FL, HC, AC, and BPD) are also activated, and display in blue on the
left side of the screen.
If a real-time image is displayed during an OB exam or syngo AutoOB is

unavailable, the measurement label buttons are inactive and display in grey.
Activating or Deactivating syngo AutoOB

To activate syngo AutoOB:
1. Begin an OB exam in 2D-mode, and press the FREEZE control on the
control panel.
2. Click the required syngo AutoOB measurement label button on the left
side of the screen (FL, HC, AC, or BPD).
The ultrasound system displays the associated AutoOB measurement
markers on the image and arbitrates a caliper to the trackball.
3. Press the SELECT control on the control panel to confirm and save the
measurement.
To undo or remove a syngo AutoOB measurement in an image:

Click Undo.
To use basic measurements (deactivate syngo AutoOB):
1. Click the Auto button on the left side of the screen.
2. To reactivate syngo AutoOB measurement, click the Auto button again.
Supplement to fourSight 4D Imaging and
3-Scape Imaging
Setting Up for Volume Acquisition .................................................................. 3
Using the CurvedTop VOI Display ................................................................. 3
Rendering Volumes............................................................................................ 4
2D-Mode Parameters for fourSight Imaging.................................................. 4
Amnioscopic Rendering................................................................................. 4
Changing the Render Direction of the Volume ............................................... 5
Using Curved MPRs............................................................................................ 6
MultiSlice ............................................................................................................ 8
Displaying MultiSlice ..................................................................................... 8
Using Thick Slice Imaging (TSI) ...................................................................... 10
Storing, Printing, and Retrieving .................................................................... 12
Storing Volumes as Clips............................................................................. 12
Reference .......................................................................................................... 13
2D-Mode Parameters for fourSight Imaging................................................ 13
fourSight Editing Group Box ........................................................................ 13
fourSight 3D/4D Advanced Group Box ........................................................ 14
Supplement to fourSight 4D Imaging and 3-Scape Imaging
Setting Up for Volume Acquisition

See also: Chapter 10, fourSight 4D Imaging and 3-Scape Imaging, [2] Instructions for Use.
Note: Predefined parameters are available using the drop down menus. The availability of
predefined parameters is dependent upon the selected exam type and transducer.
Using the CurvedTop VOI Display

You can curve the top of the VOI to define the shape of the viewing plane in
the VOI and remove extraneous information.
To use the CurvedTop VOI display with a 3D or 4D image:

1. Click either the 3D or 4D button on the Parameter menu.
2. To perform 3D or 4D acquisition, press the UPDATE/VIEW key on the
control panel.
3. To activate the CurvedTop VOI tool, press the PRIORITY TOOL key on
the control panel.
Note: You may be required to press the PRIORITY TOOL key repeatedly to cycle
through other options before you access CurvedTop VOI.
The system displays the CurvedTop VOI graphic on screen. It also

displays "C VOI" in the lower right of the screen.
CurvedTop VOI graphic.
4. To change the contours of the curve, roll the trackball to define the
new contour.
5. To finalize the curve, press the SELECT key on the control panel.
6. To return to a flattened CVOI, roll the trackball to reposition the curve
and press the SELECT key on the control panel.
Rendering Volumes
You can select a rendering method to improve contrast resolution,
transparency, and clarify detail in your data.
2D-Mode Parameters for fourSight Imaging

Note: For information about existing parameters not discussed here, see
"2D-Mode Parameters for fourSight Imaging," Chapter 3, System Controls,
[2] Instructions for Use.
Menu
Selection Tool Tip Description Settings
(current Rendering Mode Renders the data in the volume using the selected Gradient Lighting
setting) rendering method(s):
Amnioscopic
Gradient Lighting — Simulates the reflection
of light off a surface, resulting in improved
depth perception.
Amnioscopic — Simulates scattering of
directed light within an object, producing
translucency and shadowing effects.
Lighting Lighting Adjusts the lighting and shading effects used in 0 to 100%
Gradient Light Rendering. (in increments of 5)
Amnioscopic Rendering
When using the Amnioscopic rendering method, you can control the
position of the directed light source on the rendered volume. This rendering
method simulates the scattering of directed light within an object producing
translucency and shadowing effects.
To position the directed light source:

1. Click Rendering Mode on the Parameter menu, and then
select Amnioscopic.
2. Select the VR.
The system outlines the VR with a green box and displays the Light
graphic in the upper left corner of the box. It also displays "LIGHT" in the
lower right of the screen.
3. To set the light direction, roll the trackball to the required location and
press the SELECT key on the control panel.
Changing the Render Direction of the

Volume
Use the Render Direction controls to change the VOI orientation to:
Up/Down
Down/Up
Left/Right
Right/Left
Front/Back
Back/Front
To change the render direction of the volume:
1. Select the volume quadrant.
2. Click the Render Direction button on the Editing group box.
Render Direction button.
The Render Direction controls display to the right of the button.

These controls have a timed display and automatically close after a
few seconds. To redisplay them, click the Render Direction
button again.
3. Click the required render direction control.
Using Curved MPRs

You can use a curved MPR (multi-planar reformatting) to straighten curved
anatomy (such as a fetal spine) for evaluation.
A curved MPR generates cross-sections along a centerline to show details

of a curved structure and displays the result with the orthogonal reference
image of the displayed volume. The result is a straightened image of the
curved structure, intended to facilitate further evaluation.
Note: Proper care and attention must be taken in the drawing and interpretation of the
curved MPR result, as structures outside the path may be distorted because the final
image is straightened. To avoid misrepresenting and distorting anatomical structures and
their relationships, ensure that the path you draw does not cross the same object more
than once and that you always view the resulting Curved MPR image in context to the
related orthogonal slice.
To use a curved MPR:

1. Select the required volume with a curved section of anatomy.
2. Optimize the orientation and display of the required portion of the
curved anatomy in Quadrant A.
3. Click the Curved MPR button on the 3D/4D Advanced group box.
Curved MPR button.
4. To define the curved MPR image, select the method for drawing
the curve:
– Line
– Spline
– Trace
5. To activate the Curved MPR caliper, select the displayed quadrant.
6. Define a line curve:
a. Click the starting point and roll the trackball to the ending point.
b. To anchor the point and complete the line curve, press the
SELECT key on the control panel.
7. Define a spline or a trace curve:

a. Click the starting point and roll the trackball.
b. To set individual points along the curve, click the starting point, roll
the trackball, and press the NEXT/CALCS key on the control panel
at intervals.
Note: While you are drawing the curve, you can use the Backspace key on the
alphanumeric keyboard to delete the most recently drawn segment of
the shape.
c. To anchor the last point and complete the curve, press the
SELECT key on the control panel.
The VR Quadrant displays the curved anatomy as straightened.
Arrows indicate the direction in which the curve was drawn.
A red dot indicates the center of the drawn line.
8. Use the following options to display or reposition the MPR curve.
To… Do this:
Reposition the drawn MPR 1. Position the cursor over the center segment of the line to change the
curve to another location cursor to the repositioning pointer.
on the image The system displays a hand cursor.
2. Roll the trackball to drag the line to the required location.
or
Use the arrow keys on the alphanumeric keyboard to reposition the line
to the required location.
Rotate (swivel) the MPR 1. Click the cursor over either end point of the line to change the cursor to
curve around the center the rotation pointer.
point of the image 2. Roll the trackball to drag the end point in the direction of the
required rotation.
Magnify the resultant 1. Select the resultant curved MPR image.
curved MPR image 2. Rotate the ZOOM control on the control panel to adjust the zoom factor
and magnify the curved MPR result.
Rotate the resultant 1. Select the resultant curved MPR image.
curved MPR image 2. Rotate the M control on the control panel to rotate the image around the
z axis.
9. To exit the curve function, click the Curved MPR button again.
MultiSlice
Use the MultiSlice feature to view:
Multiple cross-sectional slices at the same time in any plane (A, B, or C).
An anatomy of interest in sequential order, similar to a CT or MRI scan.
A 4D CINE sequence.
Displaying MultiSlice
To display volume slices:
1. Click the MultiSlice button on the 3D/4D Advanced group box.
MultiSlice button.
2. To slice the volume vertically in the selected MPR, click the

Vertical Ranges button.
Vertical Ranges button.
3. To slice the volume horizontally, click the Horizontal Ranges button.
Horizontal Ranges button.
The VR quadrant displays a page of the slices.

Note: The asterisk indicates the center slice of the acquired volume.
4. To display and adjust the slices use the following options:

To… Do this:
Enlarge the page of multislices to Double click the UPDATE VIEW key on the control panel.
fill the viewing window
(full-screen multislice)
Display a single slice from the 1. Double click the UPDATE VIEW key on the control panel twice.
multislice page 2. To redisplay the multislice page, double-click the enlarged image.
Display the next slice of the image Click the Next Image button.
Next Image button.
Display the previous slice of the Click the Previous Image button.
image
Previous Image button.
Display the next page of slices Click the Next Page button.
Next Page button.
Display the previous page of slices Click the Previous Page button.
Previous Page button.
Change the division between 1. Select quadrant.

pages 2. Roll the trackball to pan through the images.
Adjust the distance between slices 1. Click the Slice Spacing control.
2. Rotate the MENU control on the control panel to increase or
decrease the slice thickness setting.
Change the number of slices Click the appropriate layout button.

displayed on each page
Change the reference MPR Click the appropriate MPR button.
5. To exit MultiSlice mode, click the MultiSlice button again.
Using Thick Slice Imaging (TSI)

Use the Thick-Slice Imaging (TSI) feature to improve the contrast resolution
of the image.
You can display TSI in one the following views:

A/C displays the 2D acquisition plane (A-plane) with a thick slice image
of the coronal plane (C-plane).
The A-plane image displays in the MPR quadrant on the left. A horizontal
dotted reference line indicates the center of the thick slice displayed on
the right.
The thick slice image of the coronal plane (C-plane) displays in the
VR quadrant on the right. It is displayed with the default slice
thickness setting.
A/A displays the 2D acquisition plane with a thick slice image of the
acquisition plane.
The A-plane image displays in the MPR quadrant on the left. A horizontal
dotted reference line indicates the center of the thick slice displayed on
the right.
The thick slice image of the A-plane displays in the VR quadrant on the
right. It is displayed with the default slice thickness setting.
To use TSI:
1. Click the Thick Slice Imaging button on the 3D/4D Advanced
group box.
Thick Slice Imaging button.
2. To display the 2D acquisition plane with a thick slice image of the

coronal plane, click the A/C button on the 3D/4D Advanced group box.
a. Select the MPR quadrant (on the left).
To reposition the reference line horizontally over the review
area, roll the trackball.
The image in VR quadrant (on the right) corresponds to the
location of the reference line.
To pan the reference line around the z axis, rotate the M control
on the control panel.
The image in VR quadrant (on the right) pans the area
corresponding to the reference line.
b. Select the VR quadrant (on the right).
To increase or decrease the slice thickness setting, click the
Slice Thickness control on the 3D/4D Advanced group box and
then rotate the MENU control on the control panel.
Available settings are: 2, 3, 5, 7, 10, 15, 20, 25, and 30.
To pan the image around the z axis, rotate the M control on the
control panel.
To change the size of the image, rotate the ZOOM control on
the control panel.
3. To display the 2D acquisition plane with a thick slice image of the
acquisition plane, click A/A on the 3D/4D Advanced group box.
a. Select the MPR quadrant (on the left).
To pan the center dot around the z axis, rotate the M control on
the control panel.
The image in VR quadrant (on the right) pans the area
corresponding to the reference line.
b. Select the VR quadrant (on the right).
To pan the image around the z axis, rotate the M control on the
control panel.
To zoom the image, rotate the ZOOM control on the
control panel.
4. To exit TSI mode, click the Thick Slice Imaging button again.
Storing, Printing, and Retrieving

You can store volume(s) acquired during an examination, store and print
images of the volume(s), convert a volume to a DICOM multi-frame clip, and
retrieve volumes from previous examinations.
Storing Volumes as Clips

You can store clips of the currently displayed volume(s) during continuous
review of acquired volumes or during automatic rotation.
To convert a volume to a clip in 3D or 4D Compose:

1. Press the CLIP/VOL key on the control panel.
2. To enter a name for the clip in the Enter Volume Label field, use the
alphanumeric keyboard.
3. Select the type of volume or view to be saved:
– Volume
– Clip of Acquisition Plane
– Clip of Elevation Plane
– Clip of Coronal Plane
Note: You can select any combination of options.
4. To save the volume as a clip, click Save.
To convert a volume to a clip in 4D Cine:

1. Press the CLIP/VOL key on the control panel.
2. To enter a name for the clip in the Enter Volume Label field, use the
alphanumeric keyboard.
3. Select the type of volume or view to be saved:
– 4D Cine (a volume sequence)
– 4D Single Frame (a single volume)
– Volume
– Clip of Acquisition Plane
– Clip of Elevation Plane
– Clip of Coronal Plane
Note: You can select any combination of options.
4. To save the volume as a clip, click Save.
Reference
2D-Mode Parameters for fourSight Imaging
Note: A Parameter menu may have more than one page of selections. To access
additional menu selections, click the Page indicator.
Menu
Selection Tool Tip Description Settings
(current Rendering Mode Renders the data in the volume using the selected Gradient Lighting
setting) rendering method(s):
Amnioscopic
Gradient Lighting - Simulates the reflection of
light off a surface, resulting in improved depth
perception.
Amnioscopic - Simulates scattering of directed
light within an object, producing translucency
and shadowing effects.
Lighting Lighting Adjusts the lighting and shading effects used in 0 to 100%
Gradient Light Rendering. (in increments of 5)
Note: For information about existing parameters not discussed here, see
"2D-Mode Parameters for fourSight Imaging," Chapter 3, System Controls,
[2] Instructions for Use.
fourSight Editing Group Box

Use the Editing group box to define an area within the volume to be
removed. These selections are available during acquisition, when acquisition
is paused, and for retrieved volumes.
Menu
Selection Tool Tip Description
Render Direction Changes the render direction of the VOI orientation to:
Up/Down
Down/Up
Left/Right
Right/Left
Front/Back
Back/Front
Note: For information about existing selections not discussed here, see
"fourSight Editing Group Box," Chapter 3, System Controls, [2] Instructions for Use.
fourSight 3D/4D Advanced Group Box

Use the 3D/4D Advanced group box to straighten curved anatomy using
curved MPR (multi-planar reformatting), view multiple cross-sectional slices
at the same time in any plane, and control the thickness of a slice to
improve contrast.
Menu Selection Tool Tip Description

MultiSlice Displays tools for viewing multiple cross-sectional slices at
the same time in any plane.
Horizontal Ranges Displays horizontal slices of the volume relative to the
selected MPR quadrant.
Vertical Ranges Displays vertical slices of the volume relative to the selected
MPR quadrant.
Previous Page Displays the previous page.
Previous Image Displays the previous image.
Next Image Displays the next image.
Next Page Displays the next page.
Reference MPR A Displays MPR plane A.
Reference MPR B Displays MPR plane B.
Reference MPR C Displays MPR plane C.
-- Slice Spacing Displays the spacing of the volume slices.
Layout Displays the arrangement of slices on the screen.
Thick Slice Displays tools for increasing contrast resolution in the

Imaging rendered thin volume.
MPR A to VR C Displays MPR Plane A on the left with a dotted line

indicating the center of the thick slice and VR Plane C on the
right with a default slice thickness.
MPR A to VR A Displays MPR Plane A on the left with a dotted line
indicating the center of the thick slice and VR Plane A on the
right with a default slice thickness.
-- Slice Thickness Displays the thickness of the VR slice in millimeters.
Curved MPR Displays tools for drawing a curved MPR (multi-planar

reformatting) to straighten curved anatomy.
Line Defines a curved line structure with two marker positions.
Spline Defines a curved line structure with three or more marker

positions.
Trace Defines a free-form drawn outline.
syngo Velocity Vector Imaging
Overview ............................................................................................................. 3
Compatible Clips ........................................................................................... 3
Activating syngo VVI ......................................................................................... 4
Obtaining Velocity Vector Data ........................................................................ 5

Positioning the Clip Frame............................................................................. 5
Basic Clip Review Functions ......................................................................... 5
Tracing Structures (Creating Traces).............................................................. 6
Editing and Deleting Traces.................................................................... 7
Building a New Heart Cycle Loop for Processing .......................................... 7
Processing Traces ......................................................................................... 8
Repositioning the Velocity Reference Point................................................... 8
Changing Heart Cycle Information................................................................. 9
Applying the Average Heart Cycle ................................................................. 9
Viewing Derived Data ...................................................................................... 10

Displaying Derived Data for Other Traces ................................................... 10
Defining an M-Mode Background for Curve Plots........................................ 11
Changing the Data Display .............................................................................. 12

Changing the Velocity Vector Display .......................................................... 12
Rendering 3-D Images of Parametric Velocity M-mode Graphs.................. 13
Displaying Curves on the Curve Plots.......................................................... 13
Adjusting Smoothing for Curves........................................................... 14
Displaying Values for Data Points on Curves........................................ 15
Changing the Time Interval on the Period Selector .............................. 15
Changing the Scale of the Curve Plots (Strain/Velocity Measurement
Window)............................................................................................... 15
Magnifying Curve Plots (Strain/Velocity Measurement Window) ......... 16
Exporting Images and Clips............................................................................. 17
syngo VVI Controls .......................................................................................... 18

Strain/Velocity Measurement Window ........................................................ 20
3D Window and Magnification Window............................................... 20
Global Measurements Window................................................................... 21
Heart Rate Dialog Box ................................................................................. 21
M-Mode for Plot Background Window ........................................................ 22
Dyssynchrony Analysis Window ................................................................. 22
Overview
syngo Velocity Vector Imaging (syngo VVI) is a clinical software program that
enables you to analyze volumes and other images to track and estimate tissue
velocity at selected points on a user-defined outline (trace) of a structure.
syngo VVI illustrates tissue velocity by placing velocity vectors (arrows) on the
trace. These velocity vectors (along with the velocity reference point) are the
source of the derived quantitative data, such as velocity.
Compatible Clips
You can activate syngo VVI for any clip that contains only 2D-mode data.
WARNING: Do not transfer studies from a VCR to syngo VVI. Some DICOM
header information is not captured in VCR format. Lack of adequate DICOM
header information in these studies might result in inaccurate calculations in
syngo VVI.
Activating syngo VVI

When syngo VVI is active, you can obtain and view velocity vector data based
on a traced structure. You can also print and export clips to an external
USB-compatible storage device.
To activate syngo VVI:

1. Open a study and select a clip.
You can activate syngo VVI for a selected compatible clip in an active
study or a previously-saved one.
2. Click the syngo VVI button on the left side of the screen.
3. Review and analyze the clip.
4. To exit, click the Exit button.
Obtaining Velocity Vector Data

You can obtain velocity vector data by processing a trace (contour). You can
also change the heart rate information used for the velocity vector data.
When you process a trace, the program illustrates tissue velocity using
velocity vectors (arrows). The program also derives quantitative data from the
velocity vectors and from the placement of the velocity reference point.
The velocity vectors indicate the direction and velocity of tissue motion for
each clip frame. Vector length illustrates the magnitude of velocity (speed)
while vector arrowheads illustrate direction.
Quantitative data derived from the velocity vectors includes velocity, strain,
strain rate, ejection fraction (EF), Dmin, Dmax, segmental volume, and timing
information, such as time-to-peak values. This data is depicted as curves,
parametric velocity M-mode graphs, and/or parametric segmental diagrams.
Positioning the Clip Frame

You can reposition the clip frame within the clip window. Changing the
position of the clip frame allows you to view information such as detected
heart rate.
To position the clip frame:

1. Select the clip frame.
2. Roll the trackball to the new position, and then press the SELECT key on
the control panel.
Basic Clip Review Functions

You can stop or start playback of the clip or review the clip image frame by
image frame. You can also select an image frame for display.
To stop or start playback of the clip, choose a method:

Click the Play/Stop button.
Press the right or left arrow key on the keyboard.
To review the clip image frame by image frame, choose a method:
Click the Prior or Next button.
Press the right or left arrow key on the keyboard.
Tracing Structures (Creating Traces)

You can create a trace (contour) to process for velocity vector data.
When the tracing function is active and the cursor is positioned on the clip,
the cursor shape changes to a crosshair ("+").
To create a trace:
1. If the clip is playing, click the Play/Stop button; click the Next or Prior
button to display the desired clip frame.
2. Position the cursor over the desired position on the clip.
3. Press the SELECT key to anchor the first marker.
Note: Siemens recommends anchoring the first marker as follows: for long axis
traces, on the left; for short axis traces, at the top (12 o’clock position). Siemens
recommends anchoring at least one marker for each wall segment; to evaluate
differences in motion within a wall segment, anchor several markers.
4. For each segment of the trace, move the cursor to outline the structure
and press the SELECT key to anchor the marker and end the segment.
5. To complete the trace, press the NEXT/CALCS key on the control panel
to position the last marker.
To delete a segment from a trace:

1. Position the cursor over the marker to be deleted.
The cursor shape changes to a four-pointed arrow.
2. Press the NEXT/CALCS key to delete the marker.
Editing and Deleting Traces

You can edit and delete processed traces (contours) on the VVI window.
To edit the currently displayed trace:

1. Click the Edit Trace button on the right side of the screen.
2. Position the cursor over a marker on the trace. The cursor shape changes
to a four-pointed arrow.
3 Press the SELECT key and roll the trackball to drag the marker to the
new location.
4. Press the SELECT key to set the new position.
5. To exit the editing function, click the Edit Trace button.
To delete a trace, choose a method:

On the VVI window, click the Delete button.
With the editing function active, position the cursor over a segment of the
trace and press the SELECT key. If the cursor shape changes to a
four-pointed arrow, you have selected a marker. Move the cursor off the
marker and onto a segment before pressing the SELECT key to delete
the trace.
On the History section, select a trace button and then click the Delete
button.
Building a New Heart Cycle Loop for

Processing
You can select two or more heart cycles for processing within a multiple-cycle
clip by designating clip frames. The selected heart cycles are displayed as a
single representative heart cycle and provide improved temporal resolution in
multi-cycle clips.
Note: The Average Cycle Calculation button is available for multiple-cycle clips only
before processing.
To build a new heart cycle loop for processing:

1. Click the Average Cycle Calculation button on the right side of the
screen.
The program displays the Average Cycle Calculation dialog box with the
Period Selector graph at the top.
2. Reposition the left or right vertical bar of the Period Selector graph to
designate the included clip frames:
– Position the cursor over a vertical bar on the graph and press the
SELECT key to set the new location.
3. Click Build New Loop to recalculate using the designated clip frames
and exit the dialog box.
Processing Traces
You can process traces (contours) to obtain velocity vector data.
When you process a trace, the program generates four equidistant points for
every user-defined marker in the trace (except when using the Generic Trace
processing algorithm) and plays the clip, displaying arrows to indicate the
velocity vector data. The size of the velocity vectors is indicated on the lower
right.
The program displays a button for each processed trace in the History tab on
the upper left of the screen.
To process a trace for velocity vector data:

1. Either create a trace or select an existing trace from the History tab.
2. Select a trace processing algorithm selection (such as Long Axis).
3. Choose a method:
– Click the Process Images button on the right side of the screen.
– Click the Prior or Next button.
The program plays the clip, displaying the velocity vectors (arrows).
Repositioning the Velocity Reference Point

You can reposition the velocity reference point on the clip.
The location of the velocity reference point determines the component of the
2-D velocity vector, displayed in the curves and the parametric velocity
M-mode graphs, for all windows except the Dyssynchrony Analysis window,
which references the local direction of the trace (not the velocity reference
point). The velocity vectors (arrows) are not affected by the velocity reference
point.
To reposition the velocity reference point:

1. If the clip is playing, click the Play/Stop button to display the velocity
reference point.
2. Click the velocity reference point.
When the cursor is over the velocity reference point, the cursor shape
changes to a four-pointed arrow.
3. Roll the trackball to drag the velocity reference point to a new location and
press the SELECT key to set the new velocity reference point.
4. To recalculate and update the display, click the Process Images button.
Changing Heart Cycle Information

You can change the heart rate, the number of heart beats represented by the
clip, and the number of heart beats represented by a selected segment of the
ECG trace.
To change the heart cycle information:

1. To view the program-detected heart rate on the clip, drag the slider on the
lower left until the heart rate is visible.
2. Click the Set the "Heart Rate" Value button to display the Heart Rate
dialog box.
3. To change the heart rate, click the R button (if required to clear the current
value).
4. Select digits in sequence from the buttons to the right of the Heart Rate
text box.
Note: To cancel changes and display the original heart rate, click Reset.
5. To change the number of heart beats in the clip, click in the Entire
recording corresponds to __ heartbeats text box and use the numeric
keys on the keyboard to edit the value.
6. To select a segment of the clip for use with syngo VVI and change the
number of heart beats for the segment:
a. Click at the beginning of the desired segment in the ECG trace graph
(located above the Selected trace corresponds to __ heartbeats
text box) and drag to the end of the desired segment.
b. The program highlights the selected segment of the ECG trace.
c. Repeatedly click the up or down arrow next to the Selected trace
corresponds to __ heartbeats text box to edit the current value.
Note: To cancel changes and display the original number of heart beats for the
segment, click Reset.
7. To exit the Heart Rate dialog box, click Close.

The program recalculates and updates the display.
Applying the Average Heart Cycle

To apply the calculated average heart cycle to each heart cycle in
the clip:
Select the Average Heart Cycle check box.
The program recalculates and updates the display.
Viewing Derived Data

You can view data derived from the velocity vector data for the currently
displayed trace.
To view data derived from the velocity vector data:

1. Click the button on the right side of the syngo VVI window that
corresponds to the required data.
Derived data Button
Velocity Strain/Velocity Measurement Window
Strain Strain/Velocity Measurement Window
Strain rate Strain/Velocity Measurement Window
Ejection fraction Global Measurements Window
Dmin and Dmax Global Measurements Window
Volume Global Measurements Window
Segmental volume Global Measurements Window
Timing information as related to strain, Dyssynchrony analysis
strain rate, velocity, or displacement
2. To display the previous window, click Close.
Displaying Derived Data for Other Traces

You can display derived data for previously created traces (contours).
To display derived data for another trace:

Click a numbered trace button on the History tab.
S4 - 1 0 U S E R A N D R E F E R E N C E M A N U A L S S U P P L E M E N T
Defining an M-Mode Background for

Curve Plots
You can define an M-mode background for display behind each curve plot.
The user-created drawing for the M-mode background can include multiple
segments. An M-mode background provides additional timing information.
To define and display an M-mode Background:

1. Display an image frame for definition of the freeform M-mode
background.
2. Click the MMode for Plot Background button on the right side of the
screen to display the M-mode Background window.
3. Position the cursor over the clip and press the SELECT key to anchor the
first marker.
4. For each segment of the M-mode free-form drawing, move the cursor to
create the segment and press the SELECT key to anchor the marker and
end the segment.
5. To anchor the last marker and complete the drawing, press the
NEXT/CALCS key.
6. To delete the freeform drawing and restore default settings, click Reset.
7. To adjust the gamma image setting (change both brightness and
contrast), drag the Gamma slider to the right or left.
8. To restore the original gamma image setting, click the Gamma < >
button.
9. To toggle black and white display settings, select the Reverse Colors
check box.
10. Click Close to exit the M-mode Background window and display the
previous window.
U S E R A N D R E F E R E N C E M A N U A L S S U P P L E M E N T S4 - 1 1
Changing the Data Display

You can change the velocity vector display, render 3-D images of parametric
velocity M-mode graphs, and display curves on the curve plots.
Changing the Velocity Vector Display

You can change the display of velocity vectors, such as the length and
density. The value for length of the velocity vectors is displayed. For example,
"x10" indicates that the velocity vectors are ten times the original length.
To change the velocity vector display:

1. To adjust the length of the velocity vectors (arrows), click the
Shorter Arrows or the Longer Arrows button.
Note: When comparing multiple sets of data, use the same arrow length for each set.
2. To change the density of points and velocity vectors displayed, click the
Toggle Original Border Points to Equispaced Points x4 button.
3. To display or hide the velocity vectors, click the No Arrows button to
cycle through the display settings.
Rendering 3-D Images of Parametric

Velocity M-mode Graphs
You can render 3-D images of the parametric velocity M-mode graphs
displayed in the Strain/Velocity Measurement window.
To render 3-D images of a parametric velocity M-mode graph:

1. Click the 3D button adjacent to the parametric velocity M-mode graph.
The program displays the 3-D rendering in the 3D window.
2. To rotate the 3-D image:

– Position the cursor over the image.
Note: Position the cursor at the center of the 3-D image for optimal control.
– Press the SELECT key and roll the trackball to rotate the rendering.
– Press the SELECT key again to set the new position.
3. To magnify the 3-D image, position the cursor to the right or left of the
Zoom slider and press the SELECT key
4. To restore the original settings for orientation and magnification, click
Reset.
5. Click Close to display the Strain/Velocity Measurement window.
Displaying Curves on the Curve Plots

You can display curves for selected target point(s) on the trace (contour),
selected point(s) on the parametric velocity M-mode graph, or specified
timing parameters. Available methods depend on the displayed window.
You can also display values for data points on curves, change the time interval
or scale of the curve plots, and magnify the curve plots.
The program displays curves on the curve plots in the displayed window. The
program assigns a unique color to each point selected on either the
parametric velocity M-mode graph or the trace; each curve uses the color of
the selected point.
To display a curve for: Do this:

A selected target point on 1. If the clip is playing, click the Play/Stop button.
the trace (VVI window) 2. Position the cursor over a location on the trace
and press the SELECT key to confirm the
position.
A selected point on the Position the cursor over a location on the parametric
parametric velocity M-mode velocity M-mode graph and press the SELECT key
graph (VVI window or to confirm the position.
Strain/Velocity
Note: You can select up to ten uniquely colored points.
Measurement window)
All points on the parametric Click Row by Row.

velocity M-mode graph
Note: To remove all curves from the window, click
(Strain/Velocity Delete Stored Points.
Measurement window)
All traces (Global Select (check) the Vol./Area Plot [Current] / [All]
Measurement window) check box.
The current trace only Clear the Vol./Area Plot [Current] / [All] check box.
(Global Measurement
window)
Specified timing parameters Select timing parameters.

(Dyssynchrony Analysis
Note: To display all curves, select the All Curves check
window) box. To display selected curves, clear the All Curves
check box and select check boxes for the curves. Data
on the window includes values for the displayed curves
only.
To remove all selected points on the parametric velocity M-mode graph

(VVI window):
1. Position the cursor over the parametric velocity M-mode graph and press
the NEXT/CALCS key.
The program displays the Reset Pinpoints button.
2. Click the Reset Pinpoints button.
Adjusting Smoothing for Curves

You can enable smoothing for curves on all curve plots (all windows). The
program displays a curvy line above each curve plot when smoothing is
enabled.
To enable smoothing for curves on the curve plot:

Click the Toggle Filtered/Unfiltered Plots button.
Displaying Values for Data Points on Curves

You can display the value for a data point on a curve.
When you position the cursor over a data point, the program displays a
connector line from the selected data point to the value, listed above the
curve’s plot. The value and connector line are updated according to the
position of the cursor. The program removes the value and connector line
when you exit the window.
To display the value for a data point on a curve:

Position the cursor over the data point.
Changing the Time Interval on the Period Selector

You can change the time interval on the period selector by repositioning the
left and/or right frame markers. This is available on the Strain/Velocity
Measurement window only.
To define a segment on the Period Selector:

1. Position the cursor on a new location on the left or right vertical bar of the
Period Selector graph, and then press the SELECT key.
When the cursor is over the left or right vertical bar, the cursor shape
changes to a horizontal double-arrow to indicate that a vertical bar is
available for selection and repositioning.
2. Press the SELECT key to set the new position.
Changing the Scale of the Curve Plots

(Strain/Velocity Measurement Window)
You can change the scale of curve plots on the Strain/Velocity Measurement
window.
To change the scale of a curve plot (Strain/Velocity Measurement

window only):
1. Position the cursor over the vertical scroll bar to the left of the curve plot.
2. Click the up or down arrow in the scroll bar to change the scale of the
curve plot.
Magnifying Curve Plots (Strain/Velocity

Measurement Window)
You can magnify the curve plots displayed on the Strain/Velocity
Measurement window.
Magnified curve plots display in a full-screen format.
To magnify curve plots:

1. Select the check box for each required curve plot.
2. Click Zoom.
The program magnifies the curve plots in a new window.
3. To redisplay the Strain/Velocity Measurement window, click Close.
Exporting Images and Clips

You can export syngo VVI images and clips to an external USB-compatible
storage device. Exported image files contain the displayed window without
the on-screen selections. Exported clip files contain the clip in motion, as
displayed within its clip window.
The export function is available on the Strain/Velocity Measurement window,

Global Measurements window, or Dyssynchrony Analysis window.
The program stores exported files on the root directory of the connected
storage device, using the following path (where <patient> is the patient
name): \VVI\<patient>\
The file name format for exported syngo VVI files is

(XXXX) MMDDYYYY-HHMMSS, where XXXX is the code indicating the
exported window and MMDDYYYY-HHMMSS is the date and time of export;
MM is the month, DD is the day, YYYY is the year, HH is the hour, MM is the
minute, and SS is the second. The file name extension for image files is JPG;
and for clip files, AVI. The file name codes are described below.
MAIN: VVI window.
REG: Strain/Velocity Measurement window.
REGz: Full-screen display of magnified curve plot(s).
3D: Full-screen display of 3-D rendering (parametric velocity M-mode
graph).
GLO: Global Measurement window.
CRT: Dyssynchrony Analysis window.
To export an image or clip from syngo VVI:
1. If the VVI window is displayed and the clip is playing, click the Play/Stop
button.
2. To change the clip frame displayed for the image file, click the
Next Frame or Previous Frame button.
3. Click the Export button.
The program displays a dialog box that allows you to select the location
for the exported file.
4. Select the location and click OK.

When the export function is complete, the program displays a
confirmation message.
syngo VVI Controls

Button Selection Description
-- Exit Exits the module.
Strain/Velocity Displays velocity, strain, and strain rate information
Measurement Window in the Strain/Velocity Measurement window.
Global Measurements Displays ejection fraction (EF), Dmin, Dmax,
Window volume, and segmental volume information in the
Global Measurement window.
Note: This selection may not be available for traces
processed using the Generic Curve processing
algorithm.
Dyssynchrony analysis Displays timing information (such as time-to-peak

values) related to strain, strain rate, velocity, or
displacement in the Dyssynchrony window.
Note: This selection may not be available for traces
processed using the Generic Curve processing
algorithm.
--- Long Axis Selects the Long Axis algorithm for processing the
trace.
--- Short Axis Selects the Short Axis algorithm for processing the
trace.
--- Generic Curve Selects the Generic Curve algorithm for processing
the trace.
--- Average Heart Cycle When selected (enabled), calculates and applies the
average heart cycle to each heart cycle in the clip.
Note: This selection is available for multiple-cycle clips,
after processing only.
--- Restores the original gamma image setting.
--- Gamma Adjusts the gamma image setting (changes both

brightness and contrast).
Process Images Calculates velocity vector data for the selected
trace.
New Trace Activates the tracing (outlining) function and
removes the displayed trace (if any) from the
window.
Edit trace Activates or deactivates the editing function. When
the editing function is active, points within the trace
are available for repositioning.
Set the "Heart Rate" Displays the Heart Rate dialog box for defining the
Value heart rate and number of heart beats.
Shorter Arrows Decreases the length of the velocity vectors in
two-pixel increments.

No Arrows Cycles through display settings for velocity vectors:
Display velocity vectors
Hide velocity vectors
Hide velocity vectors and trace (contour)
Longer Arrows Increases the length of the velocity vectors in
two-pixel increments.
Restore the Graphs Displays all curves on the curve plot.
Aspect
Toggle Original Border Toggles display of the user-defined trace points
Points to Equispaced with display of the program-generated trace points.
Points x4
MMode for Plot Displays the M-mode Background window to define
Background an M-mode background for display on plots behind
curves. The background is defined using a
"free-form M-mode trace."
Toggle Adjusts the smoothing in curves on all curve plots
Filtered/Unfiltered (all windows).
Plots
Average Cycle Selects one or more heart cycles within a
Calculation multiple-cycle clip for processing and display as a
representative heart cycle.
Note: This selection is available for multiple-cycle clips,
before processing only.
Export Exports an image or clip to an external

USB-compatible storage device.
--- (slider at lower left) Positions the clip frame within the clip window.
--- Reset Removes all selected points on the parametric
velocity M-mode graph.
Note: This selection is displayed on the parametric
velocity M-mode graph window.
Play/Stop Starts and stops playback of a clip. This is a toggle

control.
Next Frame Displays the next frame of a clip.
Previous Frame Displays the previous frame of a clip.
--- History Displays a button for each trace.

--- Delete Removes the displayed trace from the window.
Strain/Velocity Measurement Window

Selection Description
Row by Row Displays curves for all points in the parametric velocity
M-mode graphs.
Delete Stored Points Removes all selected points from the parametric velocity
M-mode graphs and associated curves.
Zoom Magnifies the selected curve plots to a full-screen
display.
Velocity Selects the velocity curve plot for magnification.
Strain Selects the strain curve plot for magnification.
Strain Rate Selects the strain rate curve plot for magnification.
3D Displays the 3-D window including the 3-D rendering of
information in the related parametric velocity M-mode
graph.
M-Mode for Plot Background.
Export
Close Exits the displayed window.
3D Window and Magnification Window

The following selections are displayed on the 3D window and the
magnification window accessed from the Strain/Velocity Measurement
window.
Export Exports an image or clip to an external USB-compatible
storage device.
Global Measurements Window

--- Vol./Area Plot When selected (checked), displays curves for all traces. When
[Current] / [All] unselected, displays curves for the current trace only.
M-Mode for Plot Displays the M-mode Background window to define an M-mode
Background background for display on plots behind curves. The background is defined
using a "free-form M-mode trace."
Export Exports an image or clip to an external USB-compatible storage device.
Play/Stop Starts and stops playback of a clip. This is a toggle control.
Next Frame Displays the next frame of a clip.
Previous Frame Displays the previous frame of a clip.
--- Close Exits the displayed window.
Heart Rate Dialog Box

Heart Rate Changes the heart rate.
Entire recording corresponds Changes the number of heart beats represented by the clip.
to __ heartbeats
Reset Clears the current value for the following selections: Heart Rate and
Selected trace corresponds to __ heartbeats.
Selected trace corresponds Selects a segment of the clip for use with syngo VVI and changes the
to __ heartbeats number of heart beats represented by the selected segment.
Select all Selects the entire ECG trace.
OK Saves changes and exits the dialog box.
M-Mode for Plot Background Window

Gamma Adjusts the gamma image setting (changes both brightness and contrast).
Restores the original gamma image setting.
Reset Removes the currently displayed "free-form M-mode trace."

Reverse Colors Toggles black-on-white display with white-on-black display.
Dyssynchrony Analysis Window

--- Time To Computes and displays values for the selected time parameter:
Peak (time to peak)
75% (time to 75 percent)
50% (time to 50 percent)
--- Velocity Computes, displays, and depicts values for the selected parameter:
Tangential (tangential velocity)
Radial (radial velocity)
--- Strain Computes, displays, and depicts values for strain.
--- Strain Rate Computes, displays, and depicts values for strain rate.
--- Displacement Computes, displays, and depicts values for the selected parameter:
Tangential (tangential displacement)
Radial (radial displacement)
--- All Curves When selected (enabled), displays all curves. When cleared (disabled),
displays selected curves only.
Note: Data on the window includes values for the displayed curves only.
M-Mode for Plot Displays the M-mode Background window to define an M-mode
Background background for display on plots, behind curves. The background is defined
using a "free-form M-mode trace."
--- Close Exits the displayed window.
syngo Arterial Health Analysis Package
Intended Use....................................................................................................... 3
Compatibility.................................................................................................. 3
Acquiring Clips for Use with AHP .................................................................. 3
Activating AHP.................................................................................................... 4
Reviewing the Clip in AHP............................................................................. 4
Excluding Frames from Quantification ................................................... 5
Analyzing and Quantifying IMT Data.............................................................. 5
Frame Bar............................................................................................... 6
Editing Borders....................................................................................... 8
Drawing a Border ................................................................................... 9
Calculating Distensibility and Elasticity......................................................... 11
IMT Report ........................................................................................................ 13
Accessing the IMT Report ........................................................................... 14
Editing Risk Factors.............................................................................. 14
Clearing Risk Factors............................................................................ 15
Entering Comments ............................................................................. 15
Editing Measurements ......................................................................... 15
Exporting Measurements..................................................................... 16
Reference .......................................................................................................... 17
Glossary....................................................................................................... 17
Changing Default Settings (Setup Screen) .................................................. 18
Selecting Options for the IMT ROI (Border Tab)................................... 18
Viewing Population Sets (Normals and Composite Normals
Tabs)..................................................................................................... 20
Defining Values for Population Sets ..................................................... 21
Setting Up a Protocol (Protocol Tab)..................................................... 23
Screen Controls ........................................................................................... 26
AHP Screen – Navigation Panel............................................................ 26
Image Quality Panel ............................................................................. 26
IMT Editing Tools Panel........................................................................ 27
Clinical References ...................................................................................... 28
Normals Data Values — Atherosclerosis Risk in Communities
(ARIC) Study......................................................................................... 29
Composite Normals Data Values — Atherosclerosis Risk in
Communities (ARIC) Study................................................................... 32
Intended Use
Caution: In the United States of America, federal law restricts this device to
sale or use by, or on the order of, a physician.
The syngo Arterial Health Analysis software program (AHP) provides a

method of quantifying Common Carotid Intima-Media Thickness (IMT).
Quantification of common carotid IMT is used to provide an estimate of

vascular age for use in evaluating the potential risk of cardiovascular events
in adults who do not have a history of cardiovascular disease. The AHP
program uses automated border detection to determine the maximum and
average thickness of the intima-medial layer of the carotid artery and of
plaque within the carotid artery.
Compatibility
(Requires software version 5.0 or higher)
AHP is compatible only with 2D-mode images and clips acquired with a
linear transducer.
Acquiring Clips for Use with AHP

Acquire clips from at least three segments of each blood vessel from both
the left and the right sides of the body:
Proximal and/or mid-Common Carotid Artery, if disease is noted
Distal Common Carotid Artery
Bulb (Internal Carotid Artery and External Carotid Artery)
Bifurcation
Internal Carotid Artery
Acquire images of each segment at multiple angles. Start at 180 degrees
(anterior), move obliquely and capture images at 30-degree intervals.
Note: The AHP program requires a minimum of five compatible clips of different vessel
segments to calculate values for average vascular age.
Activating AHP
You can activate AHP for a selected compatible clip in an active study or a
previously saved one.
To activate AHP:
1. Select a clip.
2. Click the syngo AHP button on the left side of the screen.
3. If essential data is missing from the patient information (such as age or
gender), enter the required information as prompted and then click
Apply.
4. Review and analyze the clip.
5. To select another clip or image, double-click a thumbnail at the bottom
of the screen.
6. To exit AHP, click the Exit button.
Reviewing the Clip in AHP

You can review the clip to evaluate and change the display of the image.
To: Select:
Display the previous frame of the clip.
Play the clip.
Stop playback.
Display the next frame of the clip.
Magnify (zoom) the current clip or frame.
Minimize the current clip or frame.
Adjust the contrast.

To reset the default setting, click the contrast icon.
Adjust the brightness.
To reset the default setting, click the brightness icon.
Pan the frame.
Excluding Frames from Quantification

You can exclude specific frames from quantification and analysis during
review of the clip.
The Deleted frame symbol indicates the frame is unavailable for quantification and
analysis.
To: Select:
Exclude the current frame from quantification.
Note: Excluding a frame does not delete the frame; it excludes the frame
from the quantification only. To include the frame in the quantification, select
the button again.
Note: Use the AHP Setup screen to view the excluded frames during clip playback.
See also: "Changing Default Settings (Setup Screen)," p. S5-18.
Analyzing and Quantifying IMT Data

Note: All distance measurements display in mm with three decimal point precision.
The AHP program provides the following measurements of the distances

between the lumen-intima boundary and the media-adventitia boundary:
Maximum IMT distance for the currently displayed frame
Mean IMT distance for the currently displayed frame
Quality index for the currently displayed frame, upon initial
detection only
Standard deviation for the currently displayed frame
Average maximum IMT distance across all non-excluded frames in
the clip
Average mean IMT distance across all non-excluded frames in the clip
Vascular age
Saved measurements display in the report and in the worksheet. You can
delete the measurements only on the worksheet.
Note: Use the AHP Setup screen to determine the range of color to apply to the
"thickness" between the lumen-intima and media-adventitia or to only display lines to
indicate the borders of the lumen-intima and media-adventitia.
Frame Bar
The indicators on the frame bar at the bottom of the screen correspond to
the ECG trace. The reference position for the displayed frame is indicated by
a white vertical line, at the far left of the graphic below. The green triangle
indicates end systole and the green "R" indicates the start and end of the
R-wave.
1. Frame bar.
2. End systole indicator.
3. Reference position indicator.
4. R-wave indicator.
To analyze the contents of the clip after activating AHP:

1. Select a population set for use in computation from the left-most
drop-down list.
2. Select a vessel segment and the angle of acquisition.
a. Select a descriptive term for the segment of the vessel from the
middle drop-down list.
Note: The AHP program uses this term to label the segment of the vessel in the
report.
b. Select the value representing the angle of acquisition from the

right-most drop-down list.
3. Select a wall setting (Near or Far) for the selected segment of the
vessel from the Wall drop-down list on the right of the screen.
4. Click the frame bar at the bottom of the screen to select the reference
position corresponding to the start of the R-wave on the ECG trace.
A vertical white line indicates the reference position.
5. Position the IMT ROI (region of interest):

The AHP program outlines the ROI in red and displays a cursor on the
left side of the ROI.
a. Click in the vessel near the wall for analysis to position the IMT ROI.
For the far wall, the upper edge of the ROI must be within the
lumen of the vessel. For the near wall, the lower edge of the ROI
must be within the lumen of the vessel.
The AHP program automatically calculates and displays
measurement values on the right side of the screen for the active
frame and for the average of all frames in the clip.
b. To lengthen the IMT ROI, drag either side of the IMT ROI to the
required location.
Measurement values automatically update after resizing of the IMT ROI.
Note: Use the AHP Setup screen to determine the initial size of the IMT ROI.
6. Edit information for IMT analysis and quantification, as required.

7. Repeat steps 2 through 6 for each required vessel segment.
8. To save IMT data to the report, click Save IMT.
Editing Borders
You can edit the border indicating the boundaries of the lumen-intima and
the media-adventitia in the active IMT ROI to adjust the data used for
quantification and analysis. A yellow line indicates the lumen-intima; a
magenta line indicates the media-adventitia. You can also clear the edits.
Example of the cursor during the edit function.
To edit the border:

1. Select the button corresponding to the segment of the vessel required
for editing.
To edit: Select:
Far lumen-intima
Near lumen-intima
Far media-adventitia
Near media-adventitia
2. To edit the border, click the intended location of each new point along
the vessel boundary.
A crossmark indicates the location of each edit point.
Note: The IMT program uses an interface near the crossmark to redraw the line.
3. To undo an edit point, click Undo Edit.
Undo Edit button.
4. To clear all of the edit points and the IMT ROI, click Clear Borders.
Clear Borders button.
5. Double-click the last point to conclude editing.

The IMT program either applies color to the lines depicting the borders
of the vessel boundaries or applies shades of color or a solid color to the
"thickness" between the lumen-intima boundary and the media-
adventitia boundary.
Note: Use the AHP Setup screen to determine the ranges of color to apply to the
"thickness" between the lumen-intima and media-adventitia or to only display lines to
indicate the borders of the lumen-intima and media-adventitia.
A color bar on the left of the screen displays the range of colors and
corresponding scale for indicating the average vessel thickness.
Drawing a Border
You can draw the border indicating the boundaries of the lumen-intima and
the media-adventitia to adjust the data used for quantification and analysis.
You can also clear the edits.
Example of the cursor during the drawing function.
To draw a border:
1. Select the button corresponding to the segment of the vessel required
for drawing the border.
To draw this border: Select:
Far lumen-intima
Near lumen-intima
Far media-adventitia
Near media-adventitia
2. To draw a border, click the intended location of each new point along
the boundary of the vessel.
A crossmark indicates the location of each point. The AHP program
automatically connects the points to draw the line.
Note: Borders can only be drawn from left to right.
3. Select the next vessel wall drawing tool.

4. Position each new point along the border of the vessel corresponding to
the previous trace.
5. To undo an edit point, click Undo Edit.
Undo Edit button.
6. To clear all of the edit points and the IMT ROI, click Clear Borders.
Clear Borders button.
7. After the lumen-intima and media-adventitia have been traced,

double-click the last point.
The AHP program applies a color indicating the average vessel
thickness.
Calculating Distensibility and Elasticity

You can measure distensibility and elasticity measurements on both an end
diastolic frame and an end systolic frame.
Note: Only one distensibility and one elasticity measurement is available for each study. If
you save more than one distensibility measurement or more than one elasticity
measurement, then the most-recently saved measurement overwrites its previous
respective measurement.
To determine distensibility and elasticity measurements:

Note: The clip must contain an ECG trace and a complete R-R heartbeat.
1. Select a clip and activate the AHP program.

2. Enter the patient's blood pressure information in the risk factor
dialog box.
a. Click Reports on the upper right of the screen.
b. Click Edit Risk Factors at the bottom of the report.
c. Select the appropriate values for systolic and diastolic blood
pressure.
d. Click Save.
3. Click Distensibility/Elasticity on the upper right of the screen.
4. Determine the vessel diameter at End Diastole (ED).
a. Click the reference position on the frame bar at the bottom of the
screen corresponding to end diastole.
See also: "Frame Bar," p. S5-6.
b. Position the IMT ROI on the far wall of the vessel in the end
diastolic frame.
The measurements for the mean IMT and the mean diameter of the
vessel display on the right of the screen.
c. Perform any necessary edits.
d. Click Save ED.
5. Determine the vessel diameter at End Systole (ES).

a. Click the reference position on the frame bar at the bottom of the
screen corresponding to the end systole.
b. Position the IMT ROI on the far wall of the vessel in the end systolic
frame.
The measurements for the mean IMT and the mean diameter of the
vessel display on the right of the screen.
c. Perform any necessary edits.
d. Click Save ES.
The AHP program automatically calculates and displays the values
for distensibility and for elasticity.
IMT Report
The report can display an overall vascular age and an overall average risk for
potential coronary heart disease.
Comparison data within the report is based upon published studies listed in
the Clinical References section. Risk analysis is based on information from
the Framingham Heart Study.
The report can contain the following averages for each segment of the
vessel:
Maximum Intima-Media Thickness
Mean Intima-Media Thickness
Standard deviation of the mean Intima-Media Thickness
Vascular age
Framingham risk score (CHD Risk)
Note: The Framingham risk score only displays if the risk factors are saved.
The report can contain the following averages across all segments of the
vessel:
Composite mean Intima-Media Thickness
Percentage-equivalence for the composite mean Intima-Media
Thickness
Note: The value only displays if five or more segments of the vessel are measured.
Average vascular age

Note: The value only displays if five or more segments of the vessel are measured
and when the chronological age is within the bounds of the composite mean IMT
normal data.
Percentage-average for CHD Risk

You may also insert comments into the report and view the following
graphs depicting the current average IMT compared to the population
(low, medium, and high) IMT age in a year:
A graph depicting the composite mean IMT across all segments
of the vessel
A graph representing the composite of each segment of the vessel
and the most-recently saved image
Accessing the IMT Report

You can edit risk factors, insert comments in the report, and edit
measurements in the worksheet.
To access the IMT Report:

1. Click Reports on the upper right of the AHP screen.
2. To change the size of the displayed report page, click the up or down
arrow in the Zoom % box on the lower right of the screen.
3. Edit the report.
To: Select:
Access the Framingham CHD Risk Factors screen and Edit Risk Factors
enter values.
Remove the display of Risk Factors from the report Clear Risk Factors
and clear all user-entered values.
Enter comments into the report. Edit Comments
Display the report with a scroll bar on the right. Show Report
Display the worksheet. Show Worksheet
Display the Worksheet Measurements screen. Edit Measurements
Note: You can delete measurements from the worksheet
only.
Editing Risk Factors

You can edit the risk factor settings for the current report. The values for risk
factor analysis display to the right of the patient data in the report.
To edit risk factors in the report:

1. Click Edit Risk Factors at the bottom of the report.
The AHP program displays the Framingham CHD Risk Factors screen.
2. Select the check box for Use Chronological Age or Use Vascular Age.
3. Enter the values for systolic and diastolic blood pressure.
4. Enter the values for both the total cholesterol and the HDL cholesterol
levels.
5. If applicable, select the check box for Smoker and/or Diabetes.
6. To save your changes, click Save.
7. To discard your changes, click Cancel.
Clearing Risk Factors

You can remove the display of risk factors from the report.
To clear risk factors:

Click Clear Risk Factors at the bottom of the report.
Entering Comments
You can enter and save comments for the current report.
To edit comments:
1. Click Edit Comments at the bottom of the report.
2. Use the keyboard to enter your comments.
3. To save your comments, click Save.
4. To discard your comments, click Cancel.
Editing Measurements
The worksheet contains the measurements for each segment of the vessel
and displays the measurements according to each vessel, view, and wall:
Minimum Intima-Media Thickness
Maximum Intima-Media Thickness
Mean Intima-Media Thickness
Vascular age
Framingham risk score
Length of the IMT ROI
You can delete measurements from the worksheet only.
To edit measurements:
1. Click Show Worksheet at the bottom of the report.
2. Click Edit Measurements at the bottom of the worksheet.
3. Select the measurements to delete for a particular vessel, view,
and wall.
4. Click Delete.
5. To save your changes, click Save.
6. To discard your changes, click Cancel.
Exporting Measurements
You can export the report and worksheet in HTML or TIFF format to a
network device, CD, or USB device. You can also export the quantification
data results, in a comma-separated variables (.csv) format readable by a
spreadsheet program (such as Excel), to a network device, CD, or USB
device.
See also: Chapter 1, Patient Data Management, [2] Instructions for Use.
Reference
The reference section provides a glossary of terminology, an explanation of
the preset settings in the Setup screen, and a listing of all the controls and
options provided in the AHP program.
Glossary
ARIC Atherosclerosis Risk in Communities study
CCA Common Carotid Artery
CHD Coronary Heart Disease
D&E Distensibility and Elasticity
ECA External Carotid Artery
ICA Internal Carotid Artery
IMB Intima-Media boundary
IMT Intima-Media Thickness
LBUL Left Bulb
LCCA Left common carotid artery
LI Lumen-intima
LIB Lumen-intima boundary
LICA Left internal carotid artery
MA Media-adventitia
MAB Media-adventitia boundary
ROI Region of Interest
RBUL Right Bulb
RCCA Right common carotid artery
RICA Right internal carotid artery
WARF Wisconsin Alumni Research Association
Changing Default Settings (Setup Screen)

The Setup screen displays tabs of selections for establishing AHP presets
for acquisition and quantification of data.
To access the Setup screen:

1. Click Setup on the upper right of the AHP screen.
The Setup screen displays the Border, Normals, Composite Normals,
and Protocol tabs.
2. Select a tab for customizing options.
3. To save changes to the settings, click Save.
4. To restore default settings, click Restore Defaults.
Selecting Options for the IMT ROI (Border Tab)

You can set up options for the display of the IMT ROI (region of interest) and
change the color schemes to apply to the "thickness" between the lumen-
intima boundary and the media-adventitia boundary.
To set up options for the ROI:

1. With the Setup screen active, select the Border tab.
2. Select an option and adjust the setting.
To: Select: Settings / Default
Specify the default setting of Wall (drop-down list) Far (factory default)
the first wall for evaluation Near
Specify the length of the IMT Search Length (cm) 2.50 – 0.25
ROI, in centimeters Factory default: 1.00
Specify the depth of the IMT Near Wall Search Depth (cm) 1.50 – 0.10
ROI for the near wall, in Factory default: 0.20
centimeters
Specify the depth of the IMT Far Wall Search Depth (cm) 1.50 – 0.10
ROI for the far wall, in Factory default: 0.50
centimeters
To: Select: Settings / Default

Omit the excluded frames Skip Excluded Frames on on, off
from clip playback Playback (check box)
Detect boundaries on all Detect All Frames (check box) on, off
frames
Note: Detecting all frames may
slow the performance of the
AHP program.
Display the IMT ROI Show Search Region (check box) on, off
Represent the vessel Display of IMT area Border lines
boundaries with lines only, or Solid shading (Mean IMT)
to apply color or shading to depicts mean IMT with a single,
the "thickness" between the solid color
lumen-intima boundary and
the media-adventitia boundary Solid shading (Max IMT)
depicts the maximum IMT with a
single, solid color
Thickness shading applies the
available range of colors to the
IMT
3. If required, change the color scheme to apply to the "thickness" between
the lumen-intima boundary and the media-adventitia boundary.
a. Select Solid shading (Mean IMT), Solid shading (Max IMT), or
Thickness shading from the Display of IMT area drop-down list.
Note: You cannot change the color for lines representing the border. The AHP
program assigns a yellow line to the lumen-intima; a magenta line to the media-
adventitia; and a red outline to indicate the IMT ROI.
b. Select the name of the current color assigned to Color_1_Low,

Color_2_Mid, Color_3_Mid_High, or Color_4_High.
c. Click the arrow on the right of the screen and then select the Web,
Custom, or System tab.
d. Select a color scheme for the AHP program to apply to the selected
IMT area.
4. To save changes to the settings, click Save.
5. To restore default settings, click Restore Defaults.
Viewing Population Sets (Normals and Composite

Normals Tabs)
You can select a population set for Normals and for Composite Normals. The
Normals tab contains population sets and data values for each segment of
the vessel. The Composite Normals tab contains population sets and data
values for all segments of the vessel.
Data values are from the Atherosclerosis Risk in Communities (ARIC) study.
To view the values used for the Normals population set and each
segment of the vessel:
1. With the Setup screen active, select the Normals tab.
2. Select the population set and segment of the vessel.
The Setup screen displays a graph indicating low, medium, and high IMT
values by age for the selected population and segment of the vessel and
a table of the actual data depicted in the graph.
To select a Composite Normals population segment:

1. With the Setup screen active, select the Composite Normals tab.
2. Select the population set.
The Setup screen displays a graph indicating low, medium, and high IMT
values by age for the selected population set and a table of the actual
data depicted in the graph.
Defining Values for Population Sets

You can define values used for population sets for Normals and Composite
Normals. In the Normals tab, you define population sets and data values for
each segment of the vessel. In the Composite Normals tab, you define
population sets and data values inclusive of all segments of the vessel.
Defining Values for Population Sets and Each Segment

of the Vessel (Normals Tab)
To define values used for the population set and each segment of the
vessel:
1. With the Setup screen active, select the Normals tab.
2. Click in the box to the right of the asterisk at the bottom of the Normals
list and use the alphanumeric keyboard to enter a name for the new
population set.
3. In the Normal data list, click in the table and use the alphanumeric
keyboard to enter your data.
a. Enter an age.
b. Insert the lower, medium, and high values for the IMT.
Note: The low value cannot be greater than either the medium or high value; the
medium value cannot be greater than the high value.
c. Enter a second row of values.

Note: The program requires at least two rows of values for each population set.
4. To save the population set, click Save.
To delete user-defined IMT data:

To remove user-defined IMT data from the Normal data list, select a
row and click Remove.
The AHP program deletes the selected row of IMT data values.
To delete a user-defined population set:

To remove a user-defined population set and its corresponding IMT
data, from the Normals list, select a protocol and click Remove.
The AHP program deletes the selected population set and all its data
values.
To restore predefined (default) settings:

Click Restore Defaults.
The AHP program deletes all user-defined population sets and displays
only the factory defaults.
Defining Values for Population Sets and All Segments

of the Vessel (Composite Normals Tab)
To define values used for the population set and all segments of the
vessel:
1. With the Setup screen active, select the Composite Normals tab.
2. Click in the box to the right of the asterisk at the bottom of the Protocol
list and use the alphanumeric keyboard to enter a name for the new
population set.
Note: The name of the population set should match the name in the Normals list on
the Normals tab, but it should not include a specific vessel.
For example: If the name of the population set in the Normals list is
ABCD_AsianFemale_RICA, enter ABCD_AsianFemale as the new population
name.
3. In the Composite normals data list, click in the table and use the
alphanumeric keyboard to enter your data.
a. Enter an age.
b. Insert the lower, medium, and high values for the IMT.
Note: The low value cannot be greater than either the medium or high value; the
medium value cannot be greater than the high value.
c. Enter a second row of values. (At least two rows of values are
required for each population set.)
4. To save the population set, click Save.
To delete user-defined IMT data:

To remove user-defined IMT data from the Composite normals data
list, select a row and click Remove.
The AHP program deletes the selected row of IMT data values.
To delete a user-defined population set:

To remove a user-defined population set and its corresponding IMT
data, from the Protocol list, select a protocol and click Remove.
The AHP program deletes the selected protocol and all its data values.
To restore predefined (default) settings:

The AHP program deletes all user-defined population sets and displays
only the factory defaults.
Setting Up a Protocol (Protocol Tab)

Important: If you define a protocol and subsequently click Restore Defaults at the
bottom of the Protocol tab, all user entries are deleted.
On the Protocol tab, the AHP program displays population sets in a drop-
down list. The program also displays the vessel name, a drop-down list of
population sets and segments of the vessel, and possible angles of
acquisition. The acquisition angles display as comma-separated variables
(CSV).
Note: The Protocol tab lists population sets and data values from the Atherosclerosis
Risk in Communities (ARIC) Study.
To assign an existing protocol to an existing vessel name:

1. With the Setup screen active, select the Protocol tab.
2. Ensure that the corresponding protocol name for the specified vessel is
displayed in the Protocol box.
3. Select a population and segment of the vessel from the Normal drop-
down list.
4. To save the protocol assignment, click Save.
To define a new protocol:

1. With the Setup screen active, select the Protocol tab.
2. Click New Protocol at the bottom of the screen.
The Protocol Name box below the Protocol drop-down list displays the
name of the protocol which can be modified.
3. In the Protocol Name box, enter a name for the new protocol.
Note: The data entered in the Composite Normals tab is mapped to the name
displayed in the Protocol box.
4. To enter a vessel name in the Vessel Name column, click in the vessel
name box and enter a new or existing vessel name.
Valid values for entry:
– Right Distal CCA
– Right Bulb
– Right ICA
– Left Distal CCA
– Left Bulb
– Left ICA
– user defined (name entered using the keyboard)
5. Select a population set from the Normal drop-down list:
– ARIC_BlackFemale_LCCA
– ARIC_BlackFemale_LBUL
– ARIC_BlackFemale_LICA
– ARIC_BlackFemale_RCCA
– ARIC_BlackFemale_RBUL
– ARIC_BlackFemale_RICA
– ARIC_BlackMale_LCCA
– ARIC_BlackMale_LBUL
– ARIC_BlackMale_LICA
– ARIC_BlackMale_RCCA
– ARIC_BlackMale_RBUL
– ARIC_BlackMale_RICA
– ARIC_WhiteFemale_LCCA
– ARIC_WhiteFemale_LBUL
– ARIC_WhiteFemale_LICA
– ARIC_WhiteFemale_RCCA
– ARIC_WhiteFemale_RBUL
– ARIC_WhiteFemale_RICA
– ARIC_WhiteMale_LCCA
– ARIC_WhiteMale_LBUL
– ARIC_WhiteMale_LICA
– ARIC_WhiteMale_RCCA
– ARIC_WhiteMale_RBUL
– ARIC_WhiteMale_RICA
– Unknown
6. Enter comma-separated variables (CSV) without any spaces in the

Orientations box.
– To view available values, click a line item and use the arrow keys on
the keyboard to view the whole line.
– To copy a line item, select the line, click the right mouse button, and
then select Copy.
– To paste a line item, select a new location, click the right mouse
button, and then select Paste.
Valid values for entry:
– Angle 300
– Angle 270
– Angle 240
– Angle 210
– Angle 180
– Angle 150
– Angle 120
– Angle 90
– Anterior
– Mid
– Posterior
Note: Valid values are dependent on the right or left vessel selection.
7. To save the selected protocol, click Save.
To delete an existing protocol:

1. Select a population set from the Protocol drop-down list.
2. Click Delete Protocol.
The AHP program allows you to delete only user-defined protocols.
Factory defaults cannot be deleted.
To restore default protocols:

The AHP program deletes all user-defined protocols and displays only
the factory defaults.
Screen Controls
Controls consist of on-screen selections, keys on the alphanumeric
keyboard, and keys on the system control panel.
AHP Screen – Navigation Panel

The navigation panel displays on the upper right of the AHP screen.
Selection
Icon (Tool Tip) Description
IMT Border Displays the IMT screen with the Image Quality Panel and the IMT Editing
Tools Panel.
Distensibility/ Displays the screen for determining distensibility and elasticity only when the
Elasticity currently displayed clip or image contains an ECG trace.
Reports Displays the IMT report and report selections.
Setup Displays the AHP Setup screen.
Exit Exits the AHP program.
Image Quality Panel

The image quality panel displays on the right of the screen.
Selection
Prior Displays the previous frame of the clip.
Run Starts playback of the displayed clip.
Stop Stops playback of the displayed clip.
Next Displays the next frame of the clip.
Zoom + Magnifies the current clip or frame.
Zoom – Minimizes the current clip or frame.
Pan Positions the current clip or frame in the window.
Contrast Adjusts the difference between the light and dark shades.
(slider)
Brightness Lightens or darkens shades.
(slider)
IMT Editing Tools Panel

Tools for editing the borders of the IMT display on the right of the screen
and are available after establishing the IMT ROI.
Selections
Selection Description Settings
Wall (drop-down list) Specify the default setting of the first wall Far
for evaluation. Near
Far Wall Tools

Button Tool Tip Description
Edit lumen- Activates the edit function for the far lumen-intima boundary.
intima
Note: This button is also available as a selection for determining distensibility and
elasticity.
Edit media- Activates the edit function for the far media-adventitia boundary.
adventitia
elasticity.
Manual trace Activates the manual trace function for the far lumen-intima boundary.
lumen-intima
Manual trace Activates the manual trace function for the far media-adventitia boundary.
media-
adventitia
Near Wall Tools

Edit lumen- Activates the edit function for the near lumen-intima boundary.
intima Note: This button is also available as a selection for determining distensibility and
elasticity.
Edit media- Activates the edit function for the near media-adventitia.
adventitia Note: This button is also available as a selection for determining distensibility and
elasticity.
Manual trace Activates the manual trace function for the near lumen-intima boundary.
lumen-intima
Manual trace Activates the manual trace function for the near media-adventitia boundary.
media-
adventitia
Trace Editing Tools

Clear borders Deletes the current border and the IMT ROI.
elasticity.
Toggle exclude Exclude or include a specific frame from analysis and quantification.
frame
Undo Edit Discards the most recent edit.

Note: This button is also available as a selection for determining distensibility
and elasticity.
-- Save IMT Saves data into the report.
Clinical References
James H. Stein, Claudia E. Korcarz, Maureen E. Mays, Pamela S. Douglas,
Mari Palta, Hongling Zhang, Tamara LeCaire, Diane Paine, David Gustafson,
and Liexiang Fan, Madison, Wisconsin, and Issaquah, Washington: A
Semiautomated Ultrasound Border Detection Program That Facilitates
Clinical Measurement of Ultrasound Carotid Intima–Media Thickness.
Journal of the American Society of Echocardiography, 18: 244–51, 2005.
James H. Stein: Carotid Intima-Media Thickness and Vascular Age: You Are
Only as Old as Your Arteries Look. Journal of the American Society of
Echocardiography,17: 686–9, 2004.
Peter W.F. Wilson, Ralph B. D’Agostino, Daniel Levy: Prediction of Coronary

Heart Disease Using Risk Factor Categories. Circulation, 97: 1837-1847,
1998. Framingham Heart Study; National Heart, Lung, and Blood Institute,
Framingham, Mass (P.W.F.W., D.L.); Boston University Mathematics
Department, Boston, Mass (R.B.D., A.M.B., H.S.); and Framingham Heart
Study, Boston University School of Medicine, Framingham, Mass (W.B.K.).
The Normals tab lists population values from the Atherosclerosis Risk in
Communities (ARIC) study. Collaborative Studies Coordinating Center,
Department of Biostatistics, School of Public Health, University of North
Carolina at Chapel Hill, 137 E. Franklin Street Suite #203, Chapel Hill, NC
27514-4145.
Normals Data Values — Atherosclerosis Risk in

Communities (ARIC) Study
The Normals tab displays normal values for population groups from the
Atherosclerosis Risk in Communities (ARIC) study. Select the population
that most closely matches the characteristics of the current patient.
Group Vessel Percentile Intercept Slope IMT at 40 IMT at 70
Black Female LCCA 10 0.18 0.0056 0.404 0.572
25 0.206 0.0064 0.462 0.654
50 0.206 0.008 0.526 0.766
75 0.176 0.0104 0.592 0.904
90 0.129 0.0134 0.665 1.067
Black Female RCCA 10 0.176 0.006 0.416 0.596
25 0.248 0.006 0.488 0.668
50 0.228 0.008 0.548 0.788
75 0.214 0.01 0.614 0.914
90 0.185 0.0126 0.689 1.067
Black Female LBUL 10 0.248 0.0056 0.472 0.64
25 0.221 0.0074 0.517 0.739
50 0.127 0.0114 0.583 0.925
75 -0.044 0.0176 0.66 1.188
90 -0.375 0.0286 0.769 1.627
Black Female RBUL 10 0.216 0.006 0.456 0.636
25 0.235 0.0074 0.531 0.753
50 0.199 0.0106 0.623 0.941
75 0.039 0.017 0.719 1.229
90 -0.151 0.0266 0.913 1.711
Black Female LICA 10 0.452 -0.0012 0.404 0.368
25 0.364 0.002 0.444 0.504
50 0.321 0.005 0.521 0.671
75 0.194 0.01 0.594 0.894
90 0.046 0.016 0.686 1.166
Black Female RICA 10 0.278 0.0024 0.374 0.446
25 0.267 0.0046 0.451 0.589
50 0.198 0.0076 0.502 0.73
75 0.055 0.0134 0.591 0.993
90 -0.369 0.027 0.711 1.521
Black Male LCCA 10 0.176 0.0064 0.432 0.624
25 0.17 0.008 0.49 0.73
50 0.164 0.01 0.564 0.864
75 0.092 0.0136 0.636 1.044
90 -0.084 0.0196 0.7 1.288

Black Male RCCA 10 0.045 0.009 0.405 0.675
25 0.064 0.01 0.464 0.764
50 0.064 0.012 0.544 0.904
75 0.025 0.015 0.625 1.075
90 -0.047 0.0186 0.697 1.255
Black Male LBUL 10 0.032 0.01 0.432 0.732
25 0.228 0.008 0.548 0.788
50 -0.032 0.016 0.608 1.088
75 -0.246 0.0236 0.698 1.406
90 -0.696 0.038 0.824 1.964
Black Male RBUL 10 0.031 0.0098 0.423 0.717
25 0.163 0.0094 0.539 0.821
50 0.152 0.0124 0.648 1.02
75 0.042 0.018 0.762 1.302
90 -0.17 0.028 0.95 1.79
Black Male LICA 10 0.257 0.003 0.377 0.467
25 0.176 0.006 0.416 0.596
50 0.047 0.011 0.487 0.817
75 -0.198 0.0184 0.538 1.09
90 -0.785 0.0346 0.599 1.637
Black Male RICA 10 0.139 0.0054 0.355 0.517
25 0.161 0.0066 0.425 0.623
50 0.08 0.0104 0.496 0.808
75 -0.067 0.0162 0.581 1.067
90 -0.775 0.0346 0.609 1.647
White Female LCCA 10 0.179 0.0054 0.395 0.557
25 0.166 0.0068 0.438 0.642
50 0.16 0.0084 0.496 0.748
75 0.16 0.01 0.56 0.86
90 0.099 0.013 0.619 1.009
White Female RCCA 10 0.166 0.0056 0.39 0.558
25 0.179 0.0066 0.443 0.641
50 0.176 0.008 0.496 0.736
75 0.16 0.01 0.56 0.86
90 0.113 0.0126 0.617 0.995
White Female LBUL 10 0.227 0.005 0.427 0.577
25 0.207 0.0066 0.471 0.669
50 0.07 0.012 0.55 0.91
75 -0.094 0.018 0.626 1.166
90 -0.476 0.0296 0.708 1.596

White Female RBUL 10 0.141 0.007 0.421 0.631
25 0.107 0.0094 0.483 0.765
50 0.028 0.0132 0.556 0.952
75 -0.19 0.0204 0.626 1.238
90 -0.662 0.034 0.698 1.718
White Female LICA 10 0.227 0.003 0.347 0.437
25 0.217 0.0046 0.401 0.539
50 0.18 0.0072 0.468 0.684
75 0.066 0.012 0.546 0.906
90 -0.361 0.0246 0.623 1.361
White Female RICA 10 0.243 0.003 0.363 0.453

25 0.223 0.005 0.423 0.573
50 0.195 0.0078 0.507 0.741
75 0.022 0.014 0.582 1.002
90 -0.331 0.0254 0.685 1.447
White Male LCCA 10 0.224 0.0052 0.432 0.588
25 0.236 0.0064 0.492 0.684
50 0.211 0.0086 0.555 0.813
75 0.168 0.0116 0.632 0.98
90 0.074 0.0156 0.698 1.166
White Male RCCA 10 0.164 0.006 0.404 0.584
25 0.154 0.0076 0.458 0.686
50 0.147 0.0094 0.523 0.805
75 0.114 0.012 0.594 0.954
90 0.016 0.016 0.656 1.136
White Male LBUL 10 0.155 0.0074 0.451 0.673
25 0.454 0.0036 0.598 0.706
50 0.056 0.014 0.616 1.036
75 -0.089 0.0206 0.735 1.353
90 -0.327 0.031 0.913 1.843
White Male RBUL 10 0.106 0.0084 0.442 0.694
25 0.081 0.011 0.521 0.851
50 -0.134 0.018 0.586 1.126
75 -0.491 0.029 0.669 1.539
90 -0.954 0.0444 0.822 2.154
White Male LICA 10 0.206 0.004 0.366 0.486
25 0.196 0.006 0.436 0.616
50 0.159 0.009 0.519 0.789
75 -0.071 0.0166 0.593 1.091
90 -0.535 0.031 0.705 1.635
White Male RICA 10 0.177 0.005 0.377 0.527
25 0.167 0.007 0.447 0.657
50 0.077 0.0114 0.533 0.875
75 -0.25 0.0216 0.614 1.262
90 -0.797 0.039 0.763 1.933
Composite Normals Data Values —

Atherosclerosis Risk in Communities (ARIC) Study
Values
Selection Age Low Medium High
ARIC_BlackFemale 40 0.482033 0.550487 0.628347
70 0.650933 0.803477 1.020537
ARIC_BlackMale 40 0.480333 0.572847 0.648001
70 0.720333 0.841857 1.172002
ARIC WhiteFemale 40 0.443167 0.512153 0.583335
70 0.638167 0.795143 1.005336
ARIC WhiteMale 40 0.491987 0.555332 0.639513
70 0.699977 0.907331 1.196523
Unknown 40 0.474 0.548 0.625
70 0.677 0.837 1.099
Wisconsin Alumni Research Foundation (WARF)
Transesophageal Transducer
About the V5Ms Transducer ............................................................................. 3
Transducer Articulation Controls.................................................................... 5
Array Rotation Control ............................................................................ 5
Flex Controls .......................................................................................... 6
Friction Brakes ....................................................................................... 7
Preparation for Use ............................................................................................ 9
Prior to First Use ........................................................................................... 9
Prior to Each Use........................................................................................... 9
Inspecting the Transducer .................................................................... 10
Using a Transducer Cover .................................................................... 11
Using Protective Drapes....................................................................... 11
Electrical Safety Considerations .................................................................. 12
Pacemakers.......................................................................................... 12
Defibrillators ......................................................................................... 12
Punctures or Cracks ............................................................................. 13
Electrosurgical Units............................................................................. 13
Using the Micro-Pinless Adapter ................................................................. 14
Imaging with the V5Ms Transducer ............................................................... 15
Changing the Imaging Scan Plane ............................................................... 16
Temperature Controls and Safeguards ........................................................ 17
Temperature Sensor Failure ................................................................. 18
Exam Considerations................................................................................... 19
Bite Guards .......................................................................................... 19
Exam Procedures ................................................................................. 19
Transesophageal Transducer — Care............................................................. 21
Cleaning and Storage................................................................................... 22
Approved Cleaning and Disinfection Agents for the V5Ms
Transducer ........................................................................................... 22
Cleaning and Disinfecting the Transducer ............................................ 23
Cleaning and Disinfecting the Bite Guard ............................................. 25
Storing and Handling ............................................................................ 25
Service and Repair....................................................................................... 25
Summary — Patient and Equipment Safety .................................................. 26
Technical Description — V5Ms ....................................................................... 28
Transducer Surface Temperature Limits ..................................................... 29
Transducer Technical Data and Acoustic Output ......................................... 29
Transducers and Intended Applications................................................ 29
Default Displayed MI and TI Values by Transducer .............................. 29
IEC 61157 Acoustic Output Reporting ................................................. 29
Track 3, FDA 510(k) Acoustic Output Reporting.......................................... 30
Summary Table for Acoustic Output .................................................... 30
Supplement to Electromagnetic Emissions and Immunity:
Guidance and Manufacturer's Declaration................................................... 34
User-Accessible Cables........................................................................ 34
About the V5Ms Transducer

WARNING: Do not use this transducer unless you are thoroughly trained in
transesophageal echocardiography and are familiar with the orientation of
cardiac images obtained through a TEE procedure. The V5Ms should be used
only by a licensed physician.
WARNING: Before attempting to use this transducer, you should be thoroughly
familiar with the safe operation of the ultrasound imaging system and this
transducer. Refer to the content of this chapter and to the Safety and Care
chapter in the Instructions for Use manual for safety-related information.
WARNING: The leakage current test for transesophageal transducers must be
done prior to each use in order to reduce the likelihood of harm to the patient.
Refer to the manufacturer's instructions included with the tester.
See also: Safety and Care, [1] Instructions for Use, Chapter 2.
The V5Ms is a multi-frequency, multi-plane, phased sector array transducer.

The transducer can be introduced into the esophagus of the patient to
obtain images of the heart structure. This procedure, known as
transesophageal echocardiography (TEE), can provide virtually unobstructed
views of the heart and surrounding tissue.
The V5Ms transducer supports the following modes:
2D-mode
M-mode
Pulsed Wave Doppler
Steerable Continuous Wave Doppler
Color Doppler
Color DTI
Pulsed Wave DTI
7 1
2
ING
RN
WA
Controls located on the handle of the V5Ms transducer

allow anterior/posterior and left/right deflection of the distal tip
and 180° rotation of the transducer array.
1 Flexible shaft
2 Cable
3 Transducer connector
4 Transducer controls
5 Distal tip (Contains rotating array)
6 Articulating section
7 Depth markings (in centimeters)
Transducer Articulation Controls

WARNING: When you insert or withdraw the transducer, ensure that the
flex controls are in the neutral alignment position, without the friction brakes
applied. Failure to do so can result in patient injury and damage to the
transducer.
Caution: Do not use your hands or fingers to bend or manipulate the articulating
section of the V5Ms transducer. To avoid severe damage to the articulating
mechanism, use only the transducer controls to change the articulation angle.
The Array Rotation Control, Flex Controls, and Friction Brakes are located on
the handle of the transducer.
Transducer controls.
1 Flex Controls
Bend the articulating section of the transducer shaft
2 Array Rotation Control
Rotates the transducer array
3 Friction Brakes (one on each side of the transducer)
Locks the flex controls
Array Rotation Control

The array rotation control rotates the array within the distal tip of
the transducer. The position of the array corresponds to the
imaging scan plane. The scan plane is adjustable from 0° to 180°.
Flex Controls
The flex controls manipulate the movement of the distal tip.
The Flex Controls are located on the handle of the transducer.
Anterior/Posterior Deflection
For anterior deflection (anteflexion) of the distal tip, rotate the
anterior/posterior flex control toward the A marking to move the
tip anteriorly.
For posterior deflection (retroflexion) of the distal tip, rotate the
anterior/posterior flex control toward the P marking to move the
tip posteriorly.
Right/Left Deflection
For right deflection of the distal tip, rotate the left/right flex control toward
the R marking to move the tip right.
For left deflection of the distal tip, rotate the left/right flex control toward
the L marking to move the tip left.
Neutral Position
To place the distal tip in the neutral position, rotate the anterior/posterior
flex control and the right/left flex control to align the N marking and
raised reference lines with the raised reference line on the handle of
the transducer.
Flex controls in the neutral alignment.
1 Anterior/Posterior flex control

2 Left/Right flex control
Friction Brakes
The friction brakes lock the deflection positions of the distal tip. When the
brakes are engaged, you can change the imaging scan plane without losing
acoustical contact.
A friction brake is located on each side of the transducer handle. The friction
brakes are color-coded to match their corresponding flex control.
Example of transducer with locked/unlocked icons. Brake

for Anterior/Posterior flex control is in the locked position.
1 Anterior/Posterior flex control (light gray)

2 Brake for Anterior/Posterior flex control (light gray)
Example of transducer without locked/unlocked icons. Brake

for Anterior/Posterior flex control is in the unlocked position.
To lock the anterior/posterior deflection position of the distal tip:

Press the raised tactile indicator located on the button of the
corresponding brake.
To unlock a brake:
Press the flat portion on the button of the corresponding brake.
Example of transducer with locked/unlocked icons. Brake

for Left/Right flex control is in the locked position.
1 Left/Right flex control (dark gray)

2 Brake for Left/Right flex control (dark gray)
Example of transducer without locked/unlocked icons. Brake

for Left/Right flex control is in the unlocked position.
To lock the left/right deflection position of the distal tip:

Press the raised tactile indicator located on the button of the
corresponding brake.
To unlock a brake:
Press the flat portion on the button of the corresponding brake.
Preparation for Use

WARNING: When using an endocavity or intraoperative transducer with a
CF type applied part, the patient leakage currents may be additive.
WARNING: The leakage current test for transesophageal transducers must be
done prior to each use in order to reduce the likelihood of harm to the patient.
Refer to the manufacturer's instructions included with the tester.
WARNING: Prior to each use, inspect the V5Ms transducer to ensure that it is
functioning properly and that it has no cuts, tears, or rough edges. A failure to do
so can result in harm to the patient or damage to the device.
WARNING: The outer surfaces of an endocavity or intraoperative transducer
should be checked to ensure there are no unintended rough surfaces, sharp
edges, or protrusions that may cause a safety hazard.
Prior to First Use

Proper precautions reduce risks to the patient and the equipment.
Review the Safety and Care section.
Thoroughly understand the features and operation of the V5Ms
transducer, particularly the use of the flex controls and friction brakes.
Clean and high-level disinfect the V5Ms transducer prior to its first use.
Perform a leakage current test on the transducer. Refer to the
manufacturer's instructions included with the tester.
Prior to Each Use

Review this checklist before each use of the V5Ms transducer to ensure
patient safety, comfort, and confidence.
Review patient history to ensure contraindications do not apply.
Thoroughly inspect the transducer for mechanical damage.
Familiarize yourself with the articulation controls.
Ensure that the transducer has been properly cleaned and has been
high-level disinfected, if disinfection is necessary.
Perform a leakage current test on the transducer. Refer to the
manufacturer's instructions included with the tester.
Place a cover on the transducer, if indicated.
If necessary, place a drape over the transducer handle, cable, connector
and the ultrasound system.
See also: Safety and Care, Chapter 2, [1] Instructions for Use.
Inspecting the Transducer

WARNING: Prior to each use, inspect the V5Ms transducer to ensure that it is
functioning properly and that it has no cuts, tears, or rough edges. A failure to do
so can result in harm to the patient or damage to the device.

To inspect the transducer before use:
1. Examine by look and touch the entire surface of the flexible shaft all
the way to the distal tip for cuts, scrapes, protrusions, holes, dents,
or cracks.
If you discover the surface of the transducer has been compromised,
do not use the transducer. Contact your local Siemens representative.
2. Test the array rotation control to ensure a smooth rotation.
3. Rotate the flex controls through the full range of motion and observe
that the control movement is smooth and easy.
If the range of motion is tight or binding, or if the transducer controls
make an unusual noise, do not use the transducer. Contact your local
Siemens representative.
If the distal tip appears to sag slightly when the flex controls are in the
neutral position, this may be a sign of stretched or damaged control
cables. Do not use the transducer. Contact your local Siemens
representative.
4. Engage the brakes (deflection locking mechanism) by pressing each
ratchet button.
The brakes hold the distal tip at the appropriate articulation angle
when locked.
Using a Transducer Cover

WARNING: There have been reports of severe allergic reactions to medical
devices containing latex (natural rubber). Health care professionals are advised
to identify latex-sensitive patients and be prepared to treat allergic reactions
promptly. For additional information in the U.S.A., refer to FDA Medical
Alert MDA91-1.
For greatest patient and operator safety, cover a transducer with a
transducer cover. Siemens recommends that you use market-cleared
transducer covers specifically designed for TEE applications. Follow the
instructions provided by the manufacturer of the transducer cover.
Disposal
While wearing protective gloves, remove the transducer cover from the
transducer and dispose of it according to the medical regulations for
biohazardous waste.
Using Protective Drapes

Follow your hospital's guidelines regarding equipment use in the presence
of infectious disease.
Electrical Safety Considerations

For safe use of this device, ensure an electrical safety procedure is in place
for periodically inspecting the grounding system in the examination area and
that this procedure is performed routinely.
Pacemakers
WARNING: Pacemakers are susceptible to the high frequency electrical signal
generated by ultrasound equipment and other surgical equipment. When using
the V5Ms transducer on a patient who has a pacemaker, pay special attention to
pacemaker operation. Stop the examination if there is interference.
Defibrillators
WARNING: The V5Ms transducer is designed to withstand the effects of
defibrillation. However, when possible, disconnect the transducer during
defibrillation since a malfunction of the safety controls could otherwise result in
electrical burns for the patient.
The V5Ms transducer is designed to withstand the effects of defibrillation.
There are no exposed conductive surfaces distal to the handle. Within the
flexible shaft, a chassis ground shield covers all active circuits and
conductors. The shield runs along the entire length of the transducer.
V5Ms transducers with this label are certified as type BF defibrillator proof
per IEC 60601-1 Standard for Safety of Medical Equipment:
Type BF Defibrillator-proof Patient Connection.
V5Ms transducers with this label are not certified as defibrillation proof:
Type BF Applied Part.
Punctures or Cracks
Punctures or cracks in the outer layer of the transducer could expose the
patient's esophagus to chassis leakage current and cause the patient to be
at the chassis ground potential. If this occurs, the transducer will no longer
meet the requirements of a type BF classification. The transducer would no
longer be a "floating" part and would fail a dielectric test. Provided that the
internal grounding mechanism within the ultrasound system's power cord is
intact and the cord is connected to a properly grounded wall outlet, there is
little hazard to the user or patient from the system's leakage current.
However, since the patient would now be at ground potential, leakage
currents from other devices within the patient's environment could travel
through the patient, compromising the safety to the patient or operator. If
punctures or cracks in the outer layer of the transducer are observed,
contact your local Siemens representative.
Electrosurgical Units
WARNING: Use only isolated output electrosurgical units with the V5Ms
transducer and disconnect the transducer when it is not in use. Failure to follow
these procedures can result in esophageal burns for the patient, damage to the
equipment, and unreliable data.
Use only electrosurgical units that have isolated outputs. If possible, use
return-fault/ground-fault detection circuits, which provide extra protection.
Electrosurgical units and other operating room devices that do not have
isolated outputs can introduce radio frequency electromagnetic fields or
currents into the patient. The transducer is susceptible to these radio
frequencies, which can interfere with the 2D-mode image and can
completely override the color flow image, making it useless for
diagnostic purposes.
In addition, any failure to an electrosurgical unit or other device, including the
V5Ms transducer, could cause electrosurgical currents to return along the
transducer's conductors. As a result, the patient could suffer from burns to
the esophageal membranes. This arcing could also damage the transducer.
To reduce the risk of leakage currents and electrosurgical interference,
disconnect the V5Ms transducer from the ultrasound system when it is not
in use.
Where isolation of electrosurgical units is in question, consult the manual for
each electrosurgical unit or contact the biomedical engineering group.
Using the Micro-Pinless Adapter

Caution: To avoid damaging the V5Ms transducer, the micro-pinless adapter, or
the ultrasound system, you must use the V5Ms transducer with the micro-
pinless adapter connected only to the second (middle) array transducer port on
the ultrasound system.
The micro-pinless adapter is required for connecting the V5Ms transducer to
the ultrasound system.
Transducer ports.
1 Valid transducer port for use with the micro-pinless adapter
To connect the micro-pinless adapter to the ultrasound system:

1. Insert the adapter into the second (middle) array transducer port.
2. Rotate the lever on the adapter clockwise to lock it in position.
3. Connect the micro-pinless transducer to the adapter.
See also: "Connecting and Disconnecting Transducers," [1] Instructions for Use,
Chapter 4.
To disconnect the micro-pinless adapter from the ultrasound system:

1. Disconnect the micro-pinless transducer from the adapter.
2. Rotate the lock on the adapter counterclockwise until it unlocks.
3. Remove the adapter from the ultrasound system.
Imaging with the V5Ms Transducer

During imaging with the V5Ms transducer, information displays on the
image screen regarding the rotation angle of the transducer array and
regarding an indication of temperature at the lens surface of the transducer
array.
Lens Temp: <37˚C
1
The Scan Plane Icon indicates the approximate rotation angle

of the imaging scan plane.
1 Temperature Indicator
Should normally display as <37°C.
2 Rotation Angle of the transducer array.
Changing the Imaging Scan Plane

You can change the imaging plane of the V5Ms transducer by using the
array rotation control to rotate the transducer crystal within the distal tip
of the transducer in a 0° to 180° range. The starting position for the
transducer is 0°.
The array rotation control is located on the handle of the transducer.
As the array orientation changes, the on-screen scan plane icon updates to
indicate the relative direction of the array and the numerical value of the
rotation angle.
The angle of 0° is The angle of 90° is The angle of 180°
equivalent to the equivalent to the provides the mirrored
transverse imaging longitudinal imaging transvere imaging
scan plane. scan plane. scan plane.
Lens Temp: <37˚C Lens Temp: <37˚C Lens Temp: <37˚C
Examples of the scan plane icon. The array rotation angle is displayed numerically at the
top of the icon.
To change the array orientation:

Press the array rotation control to increase or decrease the array rotation
angle. Press and hold the control to rapidly change the angle.
Temperature Controls and Safeguards

Because some concerns have been raised about possible thermal injury to
the esophagus due to the local buildup of heat during transesophageal
echocardiography, the V5Ms transducer incorporates a shut-off mechanism
in the interest of patient safety in the unlikely event overheating should
occur. For additional information on temperature limitation, refer to EN
60601-2-37 and IEC 60601-2-37.
A temperature sensor mounted in the distal tip of the transducer monitors
the temperature of the scanning array and displays the temperature on the
screen.
When the temperature is 37°C or below, the temperature indicator displays
<37°C.
Once the temperature is above 37°C, the system displays the actual
temperature. When the temperature reaches 40°C, the temperature
indicator is highlighted.
For example, if the temperature at the lens surface of the transducer array
reaches 40°C during the exam, the temperature indicator is highlighted and
the display changes to 40°C.
Lens Temp: 40°C
A temperature indicator is displayed above the scan plane icon.
If the temperature at the lens surface of the transducer array reaches 41°C
during the exam, the system displays the following message on the
image screen:
Thermal Limit
At thermal limit. System frozen. Press Override to continue.
To reduce acoustic output:

Lower the transmit voltage
Change scanning mode
See also: Controls affecting acoustic output, [1] Instructions for Use, Chapter 2.
If you choose to override, or if the acoustic output is reduced and the

temperature drops below 41°C, the message disappears. If the temperature
drops to 37°C or below, the on-screen temperature indicator
displays <37°C.
You may choose to override and continue to image when the temperature
indicator displays 41°C or higher without lowering the acoustic output.
However, if the acoustic output is not reduced, the lens surface at the
transducer array may reach 43ºC during imaging. If this happens, the system
automatically freezes the image. This turns off the transmitted power to the
transducer. The system displays the following message:
Thermal Limit
Maximum thermal limit exceeded. Disconnect transducer to continue. For more
instructions, see user's manual.
If the original transducer is left in place, it will not be operable until the lens
surface of the transducer array has cooled sufficiently (typically less than
one minute).
Temperature Sensor Failure

If the system detects a temperature sensor failure, the system stops
imaging and displays the following message:
Temperature Monitor Failure
Temperature monitor failure. Disconnect transducer.
Exam Considerations
Bite Guards
Bite guards are provided with the transducer for use with patients who
will be awake during the exam. These guards are also available from
third-party providers.
Do not use the provided bite guard with anesthetized patients. Use a
separately purchased bite guard that has a space for taping an endotracheal
tube to the guard.
Exam Procedures
WARNING: When you insert or withdraw the transducer, ensure that the flex
controls are in the neutral alignment position, without the friction brakes applied.
Failure to do so can result in patient injury and damage to the transducer.
WARNING: To reduce the risk of pressure necrosis, put the transducer in the
neutral position when inserting or withdrawing it. Minimize pressure applied to
the articulating section and distal tip. Do not let the distal tip displace tissue for
more than five minutes.
WARNING: Do not use the V5Ms transducer for any procedure requiring
hyperextension of the neck. Improper patient positioning can cause paralysis
of the vocal cord.
WARNING: Always use a bite guard to prevent damage to the transducer
from the patient's teeth, which could, as a result, create potential mechanical
and electrical hazards for the patient. Using a bite guard also protects the
patient's teeth.
To use the V5Ms transducer during a transesophageal

echocardiogram:
1. Remove dentures, if present, and place them in a protected area until
after the procedure.
2. Place a transducer cover on the transducer, if needed.
3. Place a bite guard around the distal end of the transducer.
4. Ensure that both friction brakes are unlocked and both flex controls are
in the neutral alignment position before inserting the transducer so that
the transducer can bend to accommodate the path of the esophagus.
5. Place the transducer in the patient's mouth, and secure the bite guard
into place before further advancing the transducer.
6. When the transducer has been inserted, press the array rotation control
to change the imaging scan plane.
7. As necessary, adjust the anterior/posterior and the left/right deflection
using the flex controls. Position the transducer for optimal acoustical
contact and the required viewing scan plane.
8. When the required scan plane is achieved and good acoustical contact
is made, engage both the anterior/posterior and the left/right friction
brakes.
9. Unlock both friction brakes and move both flex controls to the neutral
position to acquire new echocardiographic views, which necessitate
further advancement or withdrawal of the transducer, or change in
the deflection.
10. Unlock both friction brakes and move both flex controls to the neutral
position to remove the transducer.
Transesophageal Transducer — Care

WARNING: To minimize the risk of cross-contamination and infectious diseases,
endocavity and intraoperative transducers must be cleaned and high-level
disinfected after each use. A sterile, non-pyrogenic transducer sheath must be in
place during procedures requiring sterility.
WARNING: There have been reports of severe allergic reactions to medical
devices containing latex (natural rubber). Health care professionals are advised
to identify latex-sensitive patients and to be prepared to treat allergic reactions
promptly. For additional information in the U.S.A., refer to FDA Medical
Alert MDA91-1.
WARNING: During neurosurgical procedures, if a transducer becomes

contaminated with tissue or fluids of a patient known to have Creutzfeld-Jacob
disease, the transducer should be destroyed, as it cannot be sterilized.
WARNING: When using an endocavity or intraoperative transducer with a
CF type applied part, the patient leakage currents may be additive.
Caution: Transducers are sensitive instruments – irreparable damage may occur

if they are dropped, knocked against other objects, cut, or punctured. Do not
attempt to repair or alter any part of a transducer.
Caution: To avoid cable damage, do not roll the system over transducer cables.
Caution: To avoid damage to the transducer, do not use transducer sheaths

containing an oil-based coating or petroleum- or mineral oil-based ultrasound
coupling agents. Use only a water-based ultrasound coupling agent.
Caution: Follow all instructions provided by manufacturers of sterile goods
(transducer sheaths) to ensure proper handling, storage, and cycling of all sterile
goods.
Take extreme care when handling or storing transducers. They must not be
dropped, jarred, or knocked against other objects. Do not allow transducers
to come into contact with any sharp-edged or pointed object.
Cleaning and Storage

Each time the transducer is used, it must be properly cleaned
and disinfected.
Approved Cleaning and Disinfection Agents for

the V5Ms Transducer
WARNING: The use of any disinfectants other than those specified here may
damage the transducer and, as a result, may create electrical hazards for
patients and/or users.
WARNING: Disinfectants and cleaning methods listed are recommended by

Siemens for compatibility with product materials, not for biological
effectiveness. Refer to disinfectant label instructions for guidance on
disinfection efficacy and appropriate clinical uses.
Cidex
Cidex Plus
Cidex OPA
Milton
Gigasept FF
Cleaning and Disinfecting the Transducer

WARNING: To avoid electrical shock and damage to the system, disconnect the
transducer prior to cleaning or disinfecting.
WARNING: Never use Steam Heat or Ethylene Oxide for disinfecting the V5Ms
transducer. These disinfection methods may damage the jacketing material, the
transducer array, or the articulation controls, making the device unsafe to use on
a patient.
WARNING: Never use iodine or solutions containing iodine for cleaning or
disinfecting the V5Ms transducer. Iodine will cause degradation of the shaft
material and of the distal tip resulting in a dangerous electrical hazard.
Caution: Never clean the transducer with bleach. Cleaning with bleach will
damage the flexible shaft jacketing material, which will invalidate the
manufacturer's warranty and could increase leakage current.
Caution: The distal tip is very sensitive to pressure. Care must be taken not to
damage the tip while cleaning it.
Caution: Do not bend the flexible shaft into a curve of less than 30.5 cm
in diameter.
Caution: The transducers have been designed and tested to be able to
withstand high-level disinfection as recommended by the manufacturer of
the disinfectant product. Carefully follow the disinfectant manufacturer's
instructions.
Caution: Never immerse the entire V5Ms transducer in any solution. Immersion
of the transducer handle could introduce fluid into the housing and cause
damage to the controls or steering cables.
Caution: Do not immerse the transducer above 100-cm from the distal tip;
doing so may damage the controls.
Submerge only to the 100-cm mark.
To clean the V5Ms transducer:

1. Disconnect the transducer from the system.
2. Wearing protective gloves, remove the transducer cover, if appropriate.
Dispose of it in accordance with medical regulations for biohazardous
waste.
3. Clean the distal tip and flexible shaft of the transducer with gauze pads
that have been soaked in approved cleaning agents or immerse the tip
and shaft up to the 100-cm mark in an approved cleaning solution.
4. Use gauze pads dipped in a mild, soapy solution to wipe off any parts of
the transducer that cannot be immersed.
5. Rinse the distal tip and shaft up to the 100-cm mark with warm tap
water. Wipe off the soapy solution from the remaining portion of the
transducer with gauze pads moistened with tap water.
6. Clean the transducer handle with a pad moistened in 70% isopropyl
alcohol. Do not use ethanol.
7. Disinfect the transducer.
To disinfect the V5Ms transducer:
1. Immediately after cleaning, submerge the distal tip and the flexible shaft
up to the 100-cm mark in one of the approved disinfectant agents.
2. Carefully follow the disinfectant manufacturer's instructions for
high-level disinfection.
3. Dry the transducer with gauze pads. Do not use heated air.
4. Store the disinfected transducer in the original shipping case only after
disinfecting. The transesophageal transducer is fragile and should not be
stored in the transducer holders on the system.
Cleaning and Disinfecting the Bite Guard

To clean the bite guard:
1. Wearing protective gloves, wash the bite guard in mild, soapy water,
being sure to remove all debris.
2. Thoroughly rinse the guard in flowing tap water.
To disinfect the bite guard:
1. Thoroughly clean the bite guard.
2. Soak the guard in one of the approved disinfecting agents listed
above and follow the disinfectant manufacturer's directions for
high-level disinfection.
3. Rinse the guard thoroughly to remove the disinfectant.
4. Dry with a paper towel or air dry.
Storing and Handling

The V5Ms transducer is a mechanically sensitive device. The distal tip is
especially sensitive to bumps, scrapes, and jarring. Take extreme care when
handling and storing the transducer. Never move the distal tip by hand.
Always use the flex controls.
When you store the V5Ms transducer, ensure that both friction brakes
are off, the distal tip is straight, and the cables and flexible shaft are free
of kinks.
Store the disinfected transducer in the original shipping case only after
disinfecting. The transesophageal transducer is fragile and should not be
stored in the transducer holders on the system.
Transporting the Transducer
Use the case for shipping or for moving the transducer from one site to
another. Take care that the distal tip is straight and that the cable is free of
kinks as you carefully place the transducer in the foam padding. Before you
close the lid, ensure that nothing protrudes from the case.
Service and Repair

Do not attempt to repair or alter any part of the V5Ms transducer. Contact
your local Siemens service representative office immediately if your
transducer appears to be damaged or malfunctions in any way.
Summary — Patient and

Equipment Safety
Following the preventive measures outlined below will help ensure
patient safety.
Potential Harm to
Preventive Measure Problem Patient/Potential Damage
Place both V5Ms flex controls in the Improper insertion Esophageal cuts, bruising, bleeding,
neutral alignment position, without the or withdrawal ligament damage, perforations
friction brakes applied, when you insert
or withdraw it. Do not force
the transducer.
Inspect the V5Ms transducer prior to Mechanical damage, Severe trauma, esophageal cuts,
each use to ensure that it is functioning electrical damage, bleeding, perforation, electrical burns,
properly and that it has no cuts, tears, leakage current serious electrical hazards
fraying, loose parts, or rough edges.
Use only isolated output electrosurgical Non-isolated Electrical burns
units with the V5Ms transducer. electrosurgical units
Disconnect the transducer when it is
not in use.
Adjust the Transmit Voltage (dB or %) Improper transducer Esophageal burns
as low as clinically useful. Observe the temperature and/or
on-screen temperature warning acoustic output
messages and respond accordingly.
For maximum safety (where possible), Defibrillation Electrical burns
disconnect the V5Ms transducer from
the system prior to defibrillation rather
than relying on the transducer's
built-in safeguards.
Maintain a regimen of electrical Electrical damage, Esophageal burns, electrical damage
safety checks. leakage current
Put the transducer in the neutral Pressure necrosis Permanent damage to esophageal lining
position, without either friction brake
applied, when inserting or withdrawing
it. Minimize pressure applied to the
articulating section and distal tip. Do not
let the distal tip displace tissue for more
than five minutes.
Potential Harm to
Preventive Measure Problem Patient/Potential Damage
Do not use the V5Ms transducer if a Esophageal Varices Excessive bleeding
patient has esophageal varices or
masses or strictures are present.
Do not use the V5Ms transducer for any Improper patient position Paralysis of the vocal cord
procedure requiring hyperextension of
the neck.
Be aware that a patient with a loose Improper assessment of Tooth loss
tooth could lose the tooth in a dental risk
TEE procedure.
Use a bite guard. No dental protection, Dental damage, electrical damage
leakage current
Never use Steam Heat or Improper cleaning Esophageal burns
Ethylene Oxide for disinfecting the resulting in
V5Ms transducer. electrical damage
Do not use any disinfectants other than
those specified.
Do not use iodine or solutions
containing iodine for cleaning or
disinfecting the V5Ms transducer.
Immerse the V5Ms transducer no Improper disinfection, Nosocomial infection, electrical damage
longer than the time required by the exposing electrical affecting image quality, electrical safety,
manufacturer for high-level disinfection. workings to liquids or mechanical operation
Never immerse transducer controls or
the system connector in liquids.
Do not force distal tip articulation. Forcing the Stretching or breaking
Always use the controls to deflection control deflection controls
alter articulation.
When the V5Ms transducer is not in Improper storage Damage to array elements, cuts and
use, store it in the original case or abrasions to the flexible shaft
suspend it from a wall rack. Do not
store the transducer in a tight coil.
Technical Description — V5Ms

Transducer Type: Phased Array, multiplane
Elements: 64
Array Rotation Angle: 0º – 180º
Distal Tip Articulation: 120º anterior, 90º posterior
45º right, 45º left
2D-mode Transmit 3.64 MHz, 5.0 MHz, 6.15 MHz, 7.27 MHz
Frequencies:
PW Doppler and 3.3 MHz, 3.6 MHz, 3.8 MHz, 4.7 MHz
Color Frequency:
CW Doppler Frequency: 3.3 MHz, 3.6 MHz, 3.8 MHz, 4.0 MHz, 4.4 MHz
Imaging Modes: 2D-mode, PW Doppler, Steerable CW Doppler,
Color mode, M-mode, Color DTI, Pulsed Wave DTI
Maximum Image
Field of View: 90º
Image: Sector
Operating Environment
Temperature: 10ºC to +40ºC
Relative Humidity: 10% to 80%
Storage Environment
Temperature: -10ºC to +50ºC
Relative Humidity: 10% to 95%
Degree of protection V5Ms transducers with this label are certified as type BF
against electrical shock: defibrillator proof per IEC 60601-1 Standard for Safety of
Medical Equipment
V5Ms transducers with this label are certified as type BF

(not defibrillator proof) per IEC 60601-1 Standard for Safety
of Medical Equipment
Degree of protection
against ingress of fluid: IPX8
Measurement Accuracy
Rotation angle of the
transducer array: ≤3°
Temperature: Temperature Accuracy
>41°C 40.1 ≤ 41°C
>=41°C 40.1 ≤ 41°C
>=42ºC 41.1 ≤ 42°C
>=42°C and system freeze 41.9 ≤ 43°C
EMC Note: Operating the transducer in close proximity to sources of electromagnetic

fields, such as radio transmitters, may lead to temporary degradation or interference
visible on the image monitor screen. A lightening of image background may be noticed
while visualizing hypoechoic structures, or color spectral interference, or jitter, or
horizontal lines in the image screen may occur. The transducer and system have been
designed and tested to withstand such interference and will not be permanently affected.
Transducer Surface Temperature Limits

(Supplement to [1] Instructions for Use, Chapter 2, "Safety and Care)
Maximum Temperature
Transducer TMM Still Air
V5Ms ≤41°C ≤41°C
Transducer Technical Data and Acoustic

Output
(Supplement to System Reference, Chapter 1, "Acoustic Output Reference")
Transducers and Intended Applications

PHASED ARRAY TRANSDUCERS
V5Ms 3.5 – 6 MHz B, C, M, PW, CW Adult transesophageal
Default Displayed MI and TI Values by Transducer

(Per transducer/mode that exceeds default MI or TI value of 0.4)
Mode
Transducer 2D M pwD Color cwD
MI TI MI TI MI TI MI TI MI TI
V5Ms 0.5 0.7 1.2
IEC 61157 Acoustic Output Reporting

Acoustic output information for the Antares ultrasound imaging system.
Type: V5Ms
Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Division
Parameter Mode Bi Bp Ci Cp Di Dp Mi Mp
p_ (MPa) 1.94 3.79 1.64 5.03 1.65 5.25 4.47 5.59
I spta (mW/cm2) 130 9 129 53 541 53 202 166
System settings: Power (%) 100 100 100 100 100 100 100 100
Focus (cm) 13.0 2.0 13.0 3.0 4.0 4.0 3.0 3.0
Frequency (MHz) 3.64 6.15 3.81 4.71 3.81 4.71 3.64 6.15
I p (mm) 15 15 15 14 26 28 25 29
W pb6 (II) (mm) 10.9 2.6 11.0 4.6 1.6 1.5 1.1 0.9
(⊥) (mm) 5.8 7.0 5.9 7.2 2.3 2.2 2.7 2.6
prr (kHz) 11.2 0.1 0.6 0.6
srr (Hz) 215.5 90.5 36.5 12.5
Output beam dimensions
(II) (mm) 9.6 9.6 9.6 7.5 9.6 9.6 9.6 9.6
(⊥) (mm) 8.5 8.5 8.5 8.5 8.5 8.5 8.5 8.5
f awf (MHz) 3.8 5.9 3.8 4.6 3.9 4.5 3.9 5.7
APF a (%) 121 62 143 47 142 45 53 42
AIF b (%) 121 62 143 47 142 45 53 42
Maximum power (mW) 29 22 18 16 24 6 12 14
I ob (mW/cm2) 35 27 22 25 30 7 15 17
Power-up mode B B B B B B B B
Initialization mode B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes
I tt (mm) n/a n/a n/a n/a n/a n/a n/a n/a
I ts (mm) Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes - - - - B+D B+D B+M B+M
B+C+D B+C+D B+C+M B+C+M
a Acoustic power-up fraction
b Acoustic initialization fraction
Acoustic output information is presented according to the recommendations of the International

Electrotechnical Commission (IEC) as expressed in IEC 61157.
Track 3, FDA 510(k)

Acoustic Output Reporting
Summary Table for Acoustic Output

A "yes" indicates that either MI or TI index is greater than 1.0 for each
transducer/mode combination. A Track 3 acoustic output table is supplied
for each transducer/mode combination marked with "yes."
The asterisk (*) in the Power column indicates that no data is provided
because it is the same as its corresponding Color flow data.
The double asterisk (**) in the CW Doppler column indicates that the output
for steerable continuous wave Doppler is less than the output for
pulsed Doppler.
Transducer
Model Operating Mode
B-mode 2D-THI Color Power M-mode Pulsed CW
(2D) Flow Doppler Doppler
V5Ms yes yes * yes yes yes
Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)
Transducer model: V5Ms Operating mode: 2D-mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
Aaprt ≤1 Aaprt >1
Maximum Value --- 1.02 (a) - - - (a)
Pr.3 (MPa) 2.05
Associated Acoustic Parameters
Wo (mW) # - - #
min of [W.3(Z1), ITA.3(Z1)] (mW) -
Z1 (cm) -
Zbp (cm) -
Zsp (cm) 1.80 -
deq (Zsp) (cm) -
fc (MHz) 3.90 # - - - #
Dim. of Aaprt X (cm) # - - - #
Y (cm) # - - - #
PD (μsec) 0.48
Other Information
PRF (Hz) 90.19

Pr @ PII max (MPa) 2.53
d eq@ PII max (cm) -
Focal Length FLx (cm) # - - #
FLy (cm) # - - #
I pa.3 @ MI max (W/cm2) 192.73
Focus (cm) 2.00 # - - - #
Operator
Control
Frequency (MHz) 3.64 # - - - #

Res/Speed 0 # - - - #
a This Index is not relevant to this operating mode.

b This transducer is not intended for transcranial or neonatal cephalic uses.
c This formulation for TIS is less than that for an alternate formulation in this mode.
# No data is provided for this operation condition since the maximum index value is not reported for the reason listed.

Transducer model: V5Ms Operating mode: Color / Power
MI TIS TIB TIC
Aaprt ≤1 Aaprt >1
Maximum Value --- (a) 0.66 - - - 0.69
Pr.3 (MPa) #
Wo (mW) 24.94 - - 24.94

min of [W.3(Z1), ITA.3(Z1)] (mW) -
Z1 (cm) -
Zbp (cm) -
Zsp (cm) # -
deq (Zsp) (cm) -
fc (MHz) # 4.89 - - - 4.89
Dim. of Aaprt X (cm) 0.96 - - - 0.96
Y (cm) 0.85 - - - 0.85
PD (μsec) #
Other Information
PRF (Hz) #
Pr @ PII max (MPa) #
d eq@ PII max (cm) -
Focal Length FLx (cm) 4.01 - - 4.01
FLy (cm) 5.50 - - 5.50
I pa.3 @ MI max (W/cm2) #
Focus (cm) # 4.01 - - - 4.01
Operator
Control
Res/Speed # 6 - - - 6
Ensemble Size # 7 - - - 7
Frequency (MHz) # 4.71 - - - 4.71


Transducer model: V5Ms Operating mode: Pulsed Doppler
MI TIS TIB TIC
Aaprt ≤1 Aaprt >1
Maximum Value --- (a) - 0.73 - 0.87 0.80
Pr.3 (MPa) #
Wo (mW) - 31.39 17.68 16.85

min of [W.3(Z1), ITA.3(Z1)] (mW) -
Z1 (cm) -
Zbp (cm) -
Zsp (cm) # 1.20
deq (Zsp) (cm) 0.34
fc (MHz) # - 4.89 - 3.60 4.84
Dim. of Aaprt X (cm) - 0.96 - 0.49 0.25
Y (cm) - 0.85 - 0.85 0.85
PD (μsec) #
Other Information
PRF (Hz) #
d eq@ PII max (cm) 0.32
Focal Length FLx (cm) - 4.00 - 1.04
FLy (cm) - 5.50 - 5.50
Frequency (MHz) # - 4.71 - 3.33 4.71
Operator
Control
Focus (cm) # - 4.00 - 2.00 1.04

Gate Size (cm) # - 0.10 - 0.10 0.10
Sample Rate (Hz) # - 26042 - 22321 28409


Transducer model: V5Ms Operating mode: Continuous Wave Doppler
MI TIS TIB TIC
Aaprt ≤1 Aaprt >1
Maximum Value --- (a) - 0.42 - 1.29 0.94
Pr.3 (MPa) #
Wo (mW) - 26.42 26.42 19.83

min of [W.3(Z1), ITA.3(Z1)] (mW) -
Z1 (cm) -
Zbp (cm) -
Zsp (cm) # 1.10
deq (Zsp) (cm) 0.36
fc (MHz) # - 3.31 - 3.31 4.89
Dim. of Aaprt X (cm) - 0.48 - 0.48 0.25
Y (cm) - 0.85 - 0.85 0.85
PD (μsec) #
Other Information
PRF (Hz) #
FLy (cm) - 5.50 - 5.50
Frequency (MHz) # - 3.33 - 3.33 3.33
Operator
Control
Focus (cm) # - 2.01 - 2.01 1.06

Gate Size (cm) # - 0.10 - 0.10 0.10
Sample Rate (Hz) # - n/a - n/a n/a


Transducer model: V5Ms Operating mode: M-mode
MI TIS TIB TIC
Aaprt ≤1 Aaprt >1
Maximum Value --- (a) - 0.42 - 0.65 0.55
Pr.3 (MPa) #
Wo (mW) - 22.50 13.63 22.50

min of [W.3(Z1), ITA.3(Z1)] (mW) -
Z1 (cm) -
Zbp (cm) -
Zsp (cm) # 1.30
deq (Zsp) (cm) 0.26
fc (MHz) # - 3.95 - 3.75 3.95
Dim. of Aaprt X (cm) - 0.96 - 0.66 0.96
Y (cm) - 0.85 - 0.85 0.85
PD (μsec) #
Other Information
PRF (Hz) #
FLy (cm) - 5.50 - 5.50
Frequency (MHz) # - 3.64 - 3.64 3.64
Operator
Control
Focus (cm) # - 7.01 - 1.00 7.01

Gate Size (cm) # - 1.00 - 1.00 1.00
Sample Rate (Hz) # - 600 - 600 600

Supplement to Electromagnetic Emissions

and Immunity: Guidance and
Manufacturer's Declaration
User-Accessible Cables
Length
Cable Type Shielded (m) Ferrite
Transducer Cables:
V5Ms Yes ≤ 2.3 m None
Table 1. Guidance and Manufacturer's Declaration – Electromagnetic Immunity for

the Antares System with the following Transducer(s): V5Ms
The Antares system is intended for use in the electromagnetic environment specified below. The customer or
the user of the Antares system should assure that it is used in such an environment.
IEC 60601-1-2
Immunity Test Test Level Compliance Level Electromagnetic Environment - Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Antares
system, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance (d )
(See Table 2)
Conducted RF 3 Vrms V1 = 3 Vrms

⎡ 3.5 ⎤
IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 2.5 MHz d =⎢ ⎥ P
7.9 MHz to 14 MHz ⎣ V1 ⎦
V1 = 0.067 Vrms
2.5 MHz to 7.9 MHz
V1 = 0.97 Vrms
14 MHz to 80 MHz
Radiated RF 3 V/m E1 = 3 V/m

⎡ 3.5 ⎤
IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 190 MHz d =⎢ ⎥ P 80 MHz to 800 MHz
208 MHz to 800 MHz ⎣ E1 ⎦
800 MHz to 1145 MHz
1180 MHz to 1644 MHz ⎡7⎤
1763 MHz to 2.5 GHz d =⎢ ⎥ P 800 MHz to 2.5 GHz
E1 = 1.9 V/m
⎣ E1 ⎦
148 MHz to 165 MHz where P is the maximum output power rating of the
E1 = 2.1 V/m transmitter in watts (W) according to the transmitter
190 MHz to 208 MHz manufacturer and d is the recommended separation
distance in meters (m).
E1 = 1.8 V/m
1145 MHz to 1180 MHz V1 and E1 = Compliance Level
E1 = 2 V/m Field strengths from fixed RF transmitters, as
1644 MHz to 1763 MHz determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Antares system is used exceeds the applicable
RF compliance level above, the Antares system should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as changing transducers or transducer operating frequency,
or re-orienting or relocating the Antares system.
b
Within the frequency range 150 kHz to 80 MHz, field strengths should be less than the compliance level (V1).
Table 2. Recommended separation distances between portable and mobile RF communications equipment and the Antares system with the following transducer(s):
V5Ms
The Antares system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Antares system can
help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Antares
system as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m (meters)
Rated
800 MHz to
maximum 150 kHz to 80 MHz to
1145 MHz
output power 2.5 MHz to 14 MHz to 2.5 MHz 148 MHz to 190 MHz to 190 MHz 1145 MHz to 1644 MHz to
1180 MHz to
7.9 MHz 80 MHz 7.9 MHz to 165 MHz 208 MHz 208 MHz to 1180 MHz 1763 MHz
of transmitter 14 MHz 800 MHz
1644 MHz
1763 MHz to 2.5 GHz
W (watts) ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡7⎤ ⎡7⎤ ⎡7⎤
d =⎢ ⎥ P d =⎢ ⎥ P d =⎢ ⎥ P d =⎢ ⎥ P d =⎢ ⎥ P d =⎢ ⎥ P d=⎢ ⎥ P d=⎢ ⎥ P d=⎢ ⎥ P
⎣ V1 ⎦ ⎣ V1 ⎦ ⎣ V1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦
0.01 5.22 0.36 0.12 0.18 0.16 0.12 0.39 0.35 0.23
0.1 16.5 1.14 0.38 0.58 0.53 0.38 1.23 1.11 0.73
1 52.2 3.6 1.2 1.8 1.66 1.2 3.9 3.5 2.3
10 165 11.4 3.8 5.8 5.3 3.8 12.3 11.1 7.3
100 522 36 12 18 17 12 39 35 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
Manuals Errata, 4.0
Antares Systems: Manuals Errata.................................................................... 3
Standard Deviation Obstetrics: GA............................................................... 3
Screen Selections − Clip Review................................................................... 3
Starting a New Exam from the Patient Report Screen .................................. 3
Comments ..................................................................................................... 3
Auxiliary Inputs .............................................................................................. 4
External ECG ......................................................................................... 4
System Classifications................................................................................... 4
Standards Compliance .................................................................................. 4
Design Standards ................................................................................... 4
IEC 61157 Acoustic Output Reporting ........................................................... 5
Track 3, FDA 510(k) Acoustic Output Reporting ........................................... 7
Summary Table for Acoustic Output....................................................... 7
Electromagnetic Emissions and Immunity: Guidance and Manufacturer's
Declaration .................................................................................................. 10
User-Accessible Cables ....................................................................... 13
Manuals Errata
Manuals Errata
Antares Systems: Manuals Errata

Standard Deviation Obstetrics: GA
[1] Instructions for Use, 3-6
#SD: Difference between GA and Clinical Age in number(#) of SDs. It is not the
2SD(d) printed on the report page and often reported with GA. The equation for
#SD is:
2 × (GA − Clinical Age)
# SD =
2SD(d)
Screen Selections − Clip Review

Selection
Toggle Display Select to lock or unlock the format display
function during Clip Review.
Select Thumbnails Allows you to select thumbnails using the MENU

control for display in the Clip Review panel.
6 of 10 Arrange Selected (Example) Displays the number of selected

thumbnails and the total number of thumbnails.
Use to display the selected thumbnails in the Clip
Review panel.
Starting a New Exam from the Patient

Report Screen
Select the New Patient button on the lower-right of the Patient Report screen.
The ultrasound system displays the Patient Registration screen. Follow the
instructions for registering a new patient in the user manual.
Comments
[2] Instructions for Use, Calcs 1-15
A button labeled "Comments" has been added to the top-left of the Patient Report
screen. When Comments is selected, the system displays a comment section that is
shared by all applications.
Manuals Errata
Auxiliary Inputs
WARNING: The Aux 1 input is not intended for direct connection to the patient.
To reduce the risk of electrical shock while using this connection, ensure that the
external source (peripheral equipment) is properly set up and is designed for
direct patient connection.
External ECG
You can connect an external ECG cable to the ultrasound system for use with the
ECG function.
Note: Assemble the external ECG cable using the connector adapters included in the
ECG cable kit.
To connect the external ECG cable:

1. Connect the one-pin external ECG cable to the socket labeled "Aux 1 ECG"
on the front of the system.
2. To connect the external ECG cable to a device (external source), see the Example of Aux 1 ECG
device manufacturer's operating instructions. connector socket.
System Classifications
[1] Instructions for Use, 2-19, 6-35
Degree of protection against electrical shock:

Type BF applied part
Standards Compliance
Design Standards
UL 60601-1
Manuals Errata
IEC 61157 Acoustic Output Reporting

System Reference, Chapter 1

Type: P10-4
Parameter Mode Bp Bi Cp Ci Dp Di Mp Mi CwD
p_ (MPa) 3.54 2.10 6.06 2.32 6.06 4.10 6.58 6.58 0.27
2
I spta (mW/cm ) 30 222 83 308 110 950 252 252 853
System settings:
Power (%) 100 100 100 100 100 100 100 100 100
Focus (cm) 1.0 5.0 2.5 7.0 2.5 2.5 2.0 2.0 4.0
Frequency (MHz) 4.44 4.44 5.71 4.44 5.71 4.44 6.15 6.15 4.00
I p (mm) 22 20 18 18 20 18 20 20 21
W pb6 (II) (mm) 2.6 4.0 1.2 8.6 1.1 1.3 0.7 0.7 1.6
(⊥) (mm) 2.3 2.5 3.3 2.6 2.8 2.7 2.9 2.9 1.8
prr (kHz) 0.1 2.2 0.6 0.6 0.0
srr (Hz) 19.2 202.9 8.0 15.3
(II) (mm) 3.6 9.4 6.3 13.2 6.2 6.3 7.1 7.1 4.9
(⊥) (mm) 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0
f awf (MHz) 4.8 4.5 5.7 4.5 5.7 4.5 6.0 6.0 4.0
a
APF (%) 74 126 43 114 44 64 40 40 968
b
AIF (%) 74 126 43 114 44 64 40 40 968
Maximum power (mW) 39 42 20 70 5 43 28 28 20
2
I ob (mW/cm ) 214 88 65 106 18 138 78 78 80
Power-up mode B B B B B B B B B
Initialization mode B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes
I tt (mm) n/a n/a n/a n/a n/a n/a n/a n/a n/a
I ts (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes - - - - B+D B+D B+M B+M -
B+C+ B+C+
B+C+D B+C+D M M -
Acoustic output information is presented according to the recommendations of the
International Electrotechnical Commission (IEC) as expressed in IEC 61157.
Manuals Errata

Type: PX4-1
Parameter Mode Bp Bi Cp Ci Dp Di Mp Mi CwD
p_ (MPa) 3.89 3.58 3.13 3.13 4.31 3.79 4.07 2.98 0.24
2
I spta (mW/cm ) 17 284 479 479 100 923 206 305 587
System settings:
Power (%) 100 100 100 100 100 100 100 100 100
Focus (cm) 2.8 8.0 5.0 5.0 5.0 5.0 4.3 4.3 4.0
Frequency (MHz) 4.21 2.50 2.50 2.50 3.33 3.33 3.08 1.82 2.00
I p (mm) 26 44 35 35 42 42 43 40 31
W pb6 (II) (mm) 1.2 11.0 2.6 2.6 2.2 2.2 1.0 1.5 3.1
(⊥) (mm) 2.8 5.0 4.1 4.1 3.6 3.6 3.7 4.6 2.3
prr (kHz) 0.1 1.2 0.6 0.6 0.0
srr (Hz) 25.9 95.4 18.5 18.5
(II) (mm) 9.9 19.2 11.8 11.8 11.8 11.8 19.2 19.2 6.6
(⊥) (mm) 9.0 16.0 16.0 16.0 16.0 16.0 9.0 9.0 16.0
f awf (MHz) 3.7 2.3 2.5 2.5 3.3 3.3 2.8 2.0 2.0
a
APF (%) 70 76 88 88 63 72 67 92 1,158
b
AIF (%) 70 76 88 88 63 72 67 92 1,158
Maximum power (mW) 49 224 141 141 11 83 13 25 63
2
I ob (mW/cm ) 55 73 75 75 6 44 8 15 59
Power-up mode B B B B B B B B B
Initialization mode B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes
I tt (mm) n/a n/a n/a n/a n/a n/a n/a n/a n/a
I ts (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes - - - - B+D B+D B+M B+M -
B+C+ B+C+ B+C+ B+C+
D D M M -
Acoustic output information is presented according to the recommendations of the
International Electrotechnical Commission (IEC) as expressed in IEC 61157.
Manuals Errata
Track 3, FDA 510(k)

Acoustic Output Reporting
Summary Table for Acoustic Output
A "yes" indicates that either MI or TI index is greater than 1.0 for each
transducer/mode combination. A Track 3 acoustic output table is supplied for each
transducer/mode combination marked with "yes."
The asterisk (*) in the Power column indicates that no data is provided because it is
the same as its corresponding Color flow data.
Operating Mode
Transducer B-mode Color Pulsed CW
Model (2D) 2D-THI Flow Power M-mode Doppler Doppler
C5F1 yes yes yes * yes yes
C7F2 yes yes yes * yes yes
C5-2 yes yes yes * yes yes
CX5-2 yes yes yes * yes yes
CH4-1 yes yes yes * yes yes
CH6-2 yes yes yes * yes yes
EC9-4 yes yes yes
EV9F4 yes yes yes
P10-4 yes yes yes * yes yes
PH4-1 yes yes yes * yes yes
PX4-1 yes yes yes * yes yes yes
VF7-3 yes yes yes * yes yes
VFX9-4 yes yes yes * yes yes
VF13-5SP yes yes yes * yes yes
VFX13-5 yes yes yes * yes yes
CW2 yes
CW5 yes
Manuals Errata

Transducer model: P10-4 Operating mode: CW Doppler
TIS TIB
Scan Non-scan Non-scan
Index Label MI Aaprt ≤1 Aaprt >1 TIC
Maximum Value --- (a) - 0.71 - 1.93 1.83
Pr.3 (MPa) #
Wo (mW) - 29.74 21.38 21.38

min of [W.3(Z1), (mW)
ITA.3(Z1)] -
Z1 (cm) -
Zbp (cm) -
Zsp (cm) # 0.50
deq (Zsp) (cm) 0.22
fc (MHz) # - 5.00 - 4.00 4.00
Dim. of Aaprt X (cm) - 0.63 - 0.13 0.13
Y (cm) - 0.50 - 0.50 0.50
PD (μsec) #
Other Information
PRF (Hz) #
FLy (cm) - 3.00 - 3.00
Operator
Focus (mm)
Control
# - 7.00 - 1.13 1.13

Frequency (MHz) # - 5.00 - 4.00 4.00
# No data is provided for this operation condition since the maximum index value is not reported for the
reason listed.
Manuals Errata

Transducer model: PX4-1 Operating mode: CW Doppler
TIS TIB
Scan Non-scan Non-scan
Index Label MI Aaprt ≤1 Aaprt >1 TIC
Maximum Value --- (a) - - 1.33 3.57 3.04
Pr.3 (MPa) #
Wo (mW) - - 162.90 162.90

min of [W.3(Z1), (mW)
ITA.3(Z1)] 111.48
Z1 (cm) 2.10
Zbp (cm) 2.01
Zsp (cm) # 4.30
deq (Zsp) (cm) 0.57
fc (MHz) # - - 2.50 2.00 2.00
Dim. of Aaprt X (cm) - - 0.88 0.88 0.88
Y (cm) - - 1.60 1.60 1.60
PD (μsec) #
Other Information
PRF (Hz) #
Focal Length FLx (cm) - - 11.70 11.70
FLy (cm) - - 5.00 5.00
Operator
Focus (mm)
Control
# - - 11.70 11.70 11.70

Frequency (MHz) # - - 2.50 2.00 2.00
# No data is provided for this operation condition since the maximum index value is not reported for the
reason listed.
Manuals Errata
Electromagnetic Emissions and Immunity:

Guidance and Manufacturer's Declaration
Table 1. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
for the Antares system with the following Transducer(s): CW2
The Antares system is intended for use in the electromagnetic environment specified below. The customer or the user of the
Antares system should assure that it is used in such an environment.
IEC 60601-1-2
Immunity Test Test Level Compliance Level Electromagnetic Environment - Guidance
Portable and mobile RF communications equipment

should be used no closer to any part of the 10037396-
ABS-001-01-01 system, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
(See Table 2)
Conducted RF 3 Vrms V1 = 3 Vrms

⎡ 3.5 ⎤
1.02 MHz to 1.87 MHz ⎣ V1 ⎦
2.12 MHz to 80 MHz
V1 = 0.33 Vrms
0.97 MHz to 1.02 MHz
V1 = 0.002 Vrms
Radiated RF 3 V/m E1 = 3 V/m

⎡ 3.5 ⎤
IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 2.5 GHz d =⎢ ⎥ P 80 MHz to 800 MHz
⎣ E1 ⎦
⎡7⎤
d=⎢ ⎥ P 800 MHz to 2.5 GHz
⎣ E1 ⎦
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
V1 and E1 = Compliance Level
Field strengths from fixed RF transmitters, as determined
a
by an electromagnetic site survey, should be less than
b
the compliance level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
a
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Antares system is used exceeds the applicable RF
compliance level above, the Antares system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as changing transducers or transducer operating frequency, or
re-orienting or relocating the Antares system.
b
Manuals Errata
Table 2. Recommended separation distances between portable and mobile RF

communications equipment and the Antares system with the following
transducer(s): CW2
The Antares system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the Antares system can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Antares system as recommended
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter - m (meters)

Rated
maximum 150 kHz to 0.97 MHz
0.97 MHz to 1.87 MHz to 80 MHz to 800 MHz to
output power 1.02 MHz to 1.87 MHz
1.02 MHz 2.12 MHz 800 MHz 2.5 GHz
of transmitter 2.12 MHz to 80 MHz
⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡7⎤

W (watts) d =⎢ ⎥ P d =⎢ ⎥ P d =⎢ ⎥ P d =⎢ ⎥ P d=⎢ ⎥ P
⎣ V1 ⎦ ⎣ V1 ⎦ ⎣ V1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦
0.01 1.06 175 0.12 0.12 0.23
0.1 3.35 553 0.38 0.38 0.73
1 10.6 1,750 1.2 1.2 2.3
10 33.5 5,534 3.8 3.8 7.3
100 106.1 175 K 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
Manuals Errata
Table 3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

for the Antares system with the following Transducer(s): CW5
The Antares system is intended for use in the electromagnetic environment specified below. The customer or the
user of the Antares system should assure that it is used in such an environment.
Immunity IEC 60601-1-2 Electromagnetic Environment -
Test Test Level Compliance Level Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Antares system, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
(See Table 4)
Conducted RF 3 Vrms V1 = 3 Vrms ⎡ 3.5 ⎤
5.04 MHz to 9.99 MHz ⎣ V1 ⎦
9.99 MHz to 80 MHz
V1 = 0.23 Vrms
V1 = 0.715 Vrms
9.99 MHz
Radiated RF 3 V/m E1 = 3 V/m ⎡ 3.5 ⎤
IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 2.5 GHz d =⎢ ⎥ P 80 MHz to 800 MHz
⎣ E1 ⎦
⎡7⎤
d=⎢ ⎥ P 800 MHz to 2.5 GHz
⎣ E1 ⎦
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
V1 and E1 = Compliance Level
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Antares system is used exceeds the applicable RF
compliance level above, the Antares system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as changing transducers or transducer operating frequency, or re-
orienting or relocating the Antares system.
b
Manuals Errata
Table 4. Recommended separation distances between portable and mobile RF

communications equipment and the Antares system with the following
transducer(s): CW5
The Antares system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the Antares system can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Antares system as recommended
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter - m (meters)

Rated
maximum 150 kHz to 4.94 MHz
output power 4.94 MHz to 80 MHz to 800 MHz to
5.04 MHz to 9.99 MHz 9.99 MHz
of transmitter 5.04 MHz 800 MHz 2.5 GHz
9.99 MHz to 80 MHz
⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡7⎤
W (watts) d =⎢ ⎥ P d =⎢ ⎥ P d =⎢ ⎥ P d =⎢ ⎥ P d=⎢ ⎥ P
⎣ V1 ⎦ ⎣ V1 ⎦ ⎣ V1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦
0.01 1.52 0.12 0.49 0.12 0.23
0.1 4.8 0.38 1.54 0.38 0.73
1 15.2 1.2 4.9 1.2 2.3
10 48.1 3.8 15.4 3.8 7.3
100 152 12 49.0 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
User-Accessible Cables
Cable Type Shielded Length (m) Ferrite
Transducer Cables:
CW2 Yes ≤ 2.3 m None
CW5 Yes ≤ 2.3 m None
Manuals Errata

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Antares Ultrasound Imaging System

User and Reference Manuals Supplement, 5.0

S3 — Supplement to fourSight 4D Imaging and 3-Scape Imaging

S4 — syngo Velocity Vector Imaging

S5 — syngo Arterial Health Analysis Package

S7 — Manuals Errata, 4.0

S ie me ns M edi cal Sol uti on s USA , In c . 10038445-01

Accessories and Options

CD/DVD Combination Drive

Other Alphanumeric Keys

Text/Picto Group Box

Selection Description Icon

Anonymizing a Patient Study

Anonymized exams are automatically deleted from the ultrasound system

To assign anonymity to an exam:

The security package on the ultrasound system protects patient information

Logging In to the Ultrasound System

To understand the permissions assigned to your user account, or if you do

To log in using your account:

2. Select Log in Different User.

Locking the Ultrasound System

To lock the ultrasound system:

Logging Off the Ultrasound System

To log off the ultrasound system:

Disk Space Security Indicators

Advanced SieClear Spatial

Advanced SieClear Spatial Compounding is an optional 2-D image

Advanced SieClear applies up to 13 lines of sight at greater steering angles

Advanced SieClear works in combination with Dynamic Tissue Contrast

See Also: [1] Instructions for Use, Chapter 6, Compatible Transducers.

To deactivate Advanced SieClear:

Changing Advanced SieClear Settings

Changing Dynamic TCE Settings

Changing Tissue Stabilization Settings

Elasticity Imaging (EI)

To activate Elasticity Imaging:

4. If necessary, optimize the 2D-mode image using the 2D-mode menu

A "shadow" function is included with Elasticity Imaging. When the shadow

To activate the shadow function during measurements with Elasticity

Fatty Tissue Imaging (FTI)

Activating or Deactivating FTI

syngo AutoOB Measurement

Use the syngo AutoOB measurement method during an OB exam to

syngo AutoOB is automatically activated whenever you freeze an image

If a real-time image is displayed during an OB exam or syngo AutoOB is

Activating or Deactivating syngo AutoOB

To undo or remove a syngo AutoOB measurement in an image:

Setting Up for Volume Acquisition

Using the CurvedTop VOI Display

To use the CurvedTop VOI display with a 3D or 4D image:

The system displays the CurvedTop VOI graphic on screen. It also

CurvedTop VOI graphic.

2D-Mode Parameters for fourSight Imaging

To position the directed light source:

Changing the Render Direction of the

Render Direction button.

The Render Direction controls display to the right of the button.

Using Curved MPRs