Professional Documents
Culture Documents
1
USER MANUAL
Instructions for use
Doc. #: 05B46EN01
Distributed by:
Arrow International
2400 Bernville Road
Reading, PA19605 USA
Tel. 800-523-8446
(+1) 610-655-8522
Manufactured by:
Esaote Europe B.V.
Philipsweg 1, 6227 AJ Maastricht, The Netherlands
3
InViewTM User Manual
U.S.A.: Federal law restricts this device to use by or on the order of a physician.
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Article # Description
Options
Article # Description
97154 410057 Battery Pack¹)
97154 411227 Communication Package
97154 411267 Battery Charger³)
97154 411038 Mains Supply²)
97154 411102 Roll Stand Adapter
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Explanation of Symbols
Symbol Description
Video Output.
Table of Contents
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Text ................................................................................................................................... 25
Enter text.......................................................................................................................................................25
Hide text ........................................................................................................................................................25
Expose Text ..................................................................................................................................................26
Erase text line ...............................................................................................................................................26
Erase text option ...........................................................................................................................................26
Applications ..................................................................................................................... 26
Select Application..........................................................................................................................................26
Settings .........................................................................................................................................................27
Edit ................................................................................................................................................................29
Frequency .....................................................................................................................................................30
Program ............................................................................................................................ 30
System settings.............................................................................................................................................31
Caliper settings .............................................................................................................................................33
Gray Maps.....................................................................................................................................................34
Macro ............................................................................................................................................................35
How to use a Macro ......................................................................................................................................37
How to delete a Macro ..................................................................................................................................37
Installation .....................................................................................................................................................37
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The following table lists the intended clinical use of the InViewTM and its integrated probe.
Peripheral vascular
This system transmits ultrasound energy into the various parts of the body using 2D and M
Mode imaging to obtain ultrasound images. The most common structures imaged are
carotid arteries, deep veins in the arms and legs, and great vessels in the abdomen. The
system provides ultrasound guidance to assist in the placement of needles and catheters
in vascular or other anatomical structures, peripheral line placement, as well as
interventional radiology procedures.
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Safety information
$ NOTE: The user should always follow the ALARA (As Low As Reasonably
Achievable) principle. Use the lowest amount of acoustic output power for the
shortest duration of time to obtain the necessary clinical diagnostic information.
Electrical Safety
As defined in EN60601-1 (IEC Standard 601-1, Safety of Medical Electrical Equipment),
this equipment is classified as Class II, type CF (probes).
Electromagnetic Compatibility
This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-
2:2001-09. These limits are designed to provide reasonable protection against harmful interference in a
typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if
not installed and used in accordance with the instructions, may cause harmful interference to other devices
in the vincinity. However, there is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmfull interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one more of the following
measures:
In the presence of RF interference, the physisian must evaluate the image degradation and its diagnostic
impact
Warning: Use of accessories and cables other then those specified in the InView manual, Chapter “System
content and set-up”, may result in increased emission or decreased immunity of the system
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Before connecting and operating the scanner this section must be read
carefully.
Warnings
To avoid a risk of explosion the equipment must not be operated in the presence of
flammable anesthetics.
To avoid a risk of electric shock do not open the equipment. Refer servicing to
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Electromagnetic compatibility.
The system shuts down when the internal temperature exceeds: 70 °C (158 °F).
Precautions
Cleaning the probe is done by first removing the ultrasound coupling gel with a soft tissue.
Then gently wipe the probe dry using a new tissue or dry cloth.
When additional cleaning is required, use only a mild detergent or hand soap with water
and a soft cloth.
For cleaning and disinfection issues related to the InViewTM unit, its probe and
accessories, please refer to “Cleaning, Disinfection and Maintenance” paragraph in this
manual.
To avoid damage, the probe cable must not be coiled to a diameter of less than 9 cm (3.5
inch).
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Battery:
1. Connect the battery to the scanner with the provided battery cable.
2. When the battery is almost depleted, a low-battery indication will appear on the screen.
The battery will operate for another 10 minutes. Disconnect the battery from the system
and connect the battery to the charger. Insert the charger’s electrical cord into an
electrical wall socket. When the battery is recharged a green light will be visible.
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Options
Article # Description
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InViewTM Set Up
The Power connection on the rear panel of the scanner lets the system be supplied only
as follows:
InViewTM Battery
InViewTM Mains Supply
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If using a video printer, connect the video input of the printer to the video output of the
scanner marked:
If using a VCR, connect the video input of the VCR to the video output of the scanner
marked:
To prevent hazards refer to your local requirements for adequate electrical installation.
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Should you still have problems starting up the system, please contact Arrow
International.
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Throughout the manual the keys are printed in capitals and each menu word and/or line
appears in bold characters.
This chapter gives you an explanation on all keys and the basic set-up operations that
need to be performed.
The Keypad
The operating keys are situated around the LCD-screen.
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SELECT
Pressing the SELECT key, when only the ultrasound image is on the screen, will
display the main menu. By scrolling through this menu using the cursor keys ,
with the arrow pointing up and downwards, any item can be highlighted and then
activated by pressing the SELECT key again. This will display a second menu from which
any item can be chosen by using the cursor keys as before.
Pressing SELECT again will result in one of the following:
o Another menu.
o An action, for example the display of the application presets available.
o Programming of the chosen item.
ESCAPE
With the ESCAPE key you can step back through the menus.
Activating this key will make the chosen menu disappear from the screen without
activating an item from that menu.
SET
When no menus are displayed, the SET key is used to activate and control the cross for
measurement.
In some menus (gray map editor) the SET key is used for edit operations.
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ON/OFF
With this key the InViewTM can be switched on and off when powered either from Mains
supply or the battery.
FREEZE
The FREEZE key freezes or unfreezes the image. Upon unfreezing the image the
measurements are automatically cleared.
This is a software-controlled key, which has different functions depending upon the current
image mode or menu item. The function associated to this key is indicated on the screen
(for example, Macro appears next to the key for menu shortcuts and Zoom off appears
when the zoom feature is active).
IMAGE DEPTH
With the IMAGE DEPTH key the displayed image depth can be changed. Four depth steps
are available and can be set by repeatedly pressing the Image Depth key until the desired
depth is selected.
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CURSOR KEYS
STORE
This key stores the displayed ultrasound image into the memory of the unit.
Adjusts the total gain of the ultrasound image to a preferred level. The last chosen level is
stored in the nonvolatile memory.
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The Screen
The screen is divided into the following areas:
Status field
The status field displays the actual mode/status and parameters of the scanner on the left
side of the screen, such as FREEZE, DEPTH, preset...
Results field
The Results field displays the measurement result and is positioned on the left side of the
screen.
Image field
The Image field displays the ultrasound image.
The Image
Focus
The focus of an ultrasound image is defined in three planes:
1. Axial resolution
The axial resolution is defined as that in line with the ultrasound beam and it is
determined by the frequency of the probe. The higher the frequency the better the
axial resolution. However, the maximum penetration decreases.
2. Lateral resolution
Lateral resolution is defined as that in the plane of the ultrasound beam.
3. Transverse resolution
Transverse resolution is defined as that perpendicular to the plane of the ultrasound
image.
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According to the chosen depth, the focus is automatically positioned. If such position is not
satisfactory for the user, it can be adjusted by the up & down cursor keys.
Probe Frequencies
The frequency steps available in the scanner with the linear probe are indicated by the
following information: Generic (medium frequency), Resolution (high frequency), and
Penetration (low frequency).
A higher frequency is more suitable for displaying superficial vessels (for vascular studies
and vascular access applications) and structures (for small organ and musculoskeletal
applications).
A lower frequency is more suitable for displaying deeper vessels (for vascular studies and
vascular access applications) and structures (for small organ and musculoskeletal
applications). In the latter case, the user should be aware that lowering the frequency of
the scanner improves the penetration and decreases the resolution.
Video processing
The scanner enables digital grayscale conversion.
Grayscale conversion can be useful in certain applications to enhance the visibility of
tissues.
The scanner has 4 preprogrammed and two user programmable gray maps. The gray
maps influences the video grayscales just before the video output to the LCD.
It is possible to program two gray maps. For this function please refer to the Gray Maps
paragraph in the next chapter.
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Basic settings configuring the InViewTM and its imaging are stored in the non-volatile
memory of the scanner. This means that when the electrical power is switched off, the
settings will be retained and re-used when the InViewTM starts up.
The InViewTM non-volatile settings are organized into two different levels. These levels are:
1. System settings
2. Application settings
Programming “application settings” requires the settings to be adjusted during the normal
use of the system. Then the settings must be saved under a preset before switching off the
system. This concept is also referred to as “programming by example”.
System settings
System settings comprise all configurable items in the scanner, including application
settings. The programming of these settings is described in the Menu chapter, page 27.
System parameters that can be programmed are:
Watchdog (powersaver)
Time and date
Time format and date format
Gray tone of text annotation (Color in the menu)
Caliper settings
Macro keys
All active menu selections
Measurement methods
Measurement unit
Scale Format
Central Marker
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Application settings
The InViewTM is completely programmable to the user’s preference. The user may
program the scanner for different applications (presets).
Up to 10 presets may be programmed.
1. If the preset name does not exist, create a new ‘application preset’ name under
Applications in the menu or rename an existing preset and enter a seven character
alphanumeric name (refer to Menu chapter for programming directions). When editing is
complete, press SELECT twice to confirm the new name.
2. Set the application preferences according to the users preferences by normal operation
of the scanner.
3. If satisfied with the settings, return to the Applications menu and choose Edit, a third
menu will be displayed. Select now Save Application.
System parameters stored as part of “Application settings” are:
Gray map
M Mode speed
Image depth
DNF (Dynamic Noise Filter)
Image upside down
Reverse
Dynamic range
Focus Positioning
Focal Points number
Frequency/Depth
Creating a new application preset is also possible by following the procedure below.
1. Set the settings of the system during the normal use of the InViewTM.
2. If satisfied with the settings, save under application preset by selecting Applications –
Edit – Save Application As in the menu.
3. Enter a 7 character alphanumeric name for the preset identification and then press
SELECT twice to confirm.
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Main Menu
The scanner employs an extensive 'pull-down' menu structure. These menus will be
explained as the different items are being discussed.
Image modes
Select the Image modes and a second menu will appear on the screen:
B Mode
B+B Mode
B+M Mode
M Mode
Zoom
B Mode
The InViewTM will start up in single image live B Mode.
Selecting the B Mode will always result in switching back to single image live B
Mode.
Double B Mode
Selecting B+B Mode will result in a double B Mode image on the screen.
Once the scanner is in dual image mode, the B+B Mode must be selected again
to change the live image from the left side to the right side or vice versa.
The selection of a double image mode will be indicated by the appearance of a
box with the image mode letter ("B") directly below the time in the upper left corner
of the scanner. There will be two boxes, one for the right image and one for the
left image. A highlighted "B" will appear in the active side.
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B + M Mode
Select B+M Mode. On the screen, the B Mode image will be on the left side and
the M Mode image will be on the right side.
A dotted line will appear in the B Mode image. This is the M Mode selection line.
Position this line in the center of the image that is being checked for movement.
Its position is changed by using the cursor keys.
The selection of a double image mode will be indicated by the appearance of a
box with the image mode letter ("B") directly below the time in the upper left corner
of the scanner. There will be two boxes, one for the right image and one for the
left image. A highlighted "B" will appear in the B image side and a highlighted M
will appear in the M image side. To freeze the M Mode image, select the B+M
mode again. Only the "B" box will remain highlighted. To unfreeze the M Mode,
select B+M mode again.
The distance between two dotted vertical lines on the M Mode image represents 1
second. The total sweep time over the entire width of the screen is indicated in the
status field: T:...s
To change the M Mode sweep speed, choose Applications from the main menu,
then Settings, then M Mode speed.
• A bar will be displayed at the bottom of the image.
• Use the CURSOR KEYS to select a M Mode speed (1 – 5)
• Press SELECT to store the speed.
M Mode
Select M Mode and the M Mode image will be displayed over the entire width of
the screen. The distance between two dotted vertical lines on the M Mode image
represents 1 second. The total sweep time over the entire width of the screen is
indicated in the status field: T:...s
Zoom
Zoom can be activated when the scanner displays a single live B Mode image.
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• The possibility to move the zoom box on the image and the number of steps
available to resize the box depend on image depth, as displayed on the table
below.
Zoom can be also selected through the menu: Image Modes – Zoom.
Macros (Shortcuts)
Select Macros and a second menu will appear on the screen whenever there are Macros
programmed. The Macro menu will only show the programmed Macros. How to program a
Macro is under Program – Macro.
Save/Recall image
Select Save/Recall image and a second menu will appear on the screen.
Image to disk
Image from disk
Delete from disk
Format disk
Image to disk
Select this item and the frozen image will be stored in the scanner’s memory.
The following modes can be stored to disk: B Mode image, B+B Mode image, B+M
Mode image, M Mode image, and Zoom mode image.
The number of images that can be stored is more than 300.
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[DIR] 13-01-04
[DIR] 20-01-04
[DIR] 29-01-04
[DIR] 13-01-04 means a directory of images made on January 13 in the year 2004.
The directory display depends on date format chosen.
Selecting one of these directories will display a menu with all the images stored on
that date.
B_103022.BMP
BB104500
…
B_103022: means a B Mode (or Zoom mode) image stored at 10.30.22 hour
BB104500: means a B+B Mode image stored at 10.45.00 hour
[DIR] 13-01-04
[DIR] 20-01-04
[DIR] 29-01-04
[DIR] 13-01-04 means a directory of images made on January 13 in the year 2004.
Selecting one of these directories will display a menu with all the images stored on
that date.
It is possible to delete more than one image at a time. Choose the image(s) you
want to delete and press SET. The selected image(s) will be marked by a check
mark (√). Pressing SELECT deletes the marked image(s) from the disk.
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Format disk
Select this item and the memory will be formatted. All stored images will be
deleted.
Text
Selecting Text displays the following option list:
Enter text
Hide text / Expose Text
Erase text line
Erase text option
Enter text
Displays the following list of options:
Line1
Line2
Line3
Header1
Header2
Header3
The user may change the headers at the bottom of the image (such as Hospital,
Patient, Physician…) and the corresponding text.
The header constitutes the title of the line as well as a line of text.
Every line will have the structure “Header: Text”.
Line 1 is programmed at the manufacturer for patient ID. It is the only text line that
is automatically reset every time the scanner restarts.
Hide text
Selecting Hide text hides the three text lines (headers included) so that will be no
longer visible on the screen. When Expose Text option is active, the option Hide
Text appears in the menu.
With Hide text option on, stored or printed images will not display text.
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Expose Text
When Hide Text option is active, the option Expose Text appears in the menu.
Selecting Expose Text shows the hidden text on the screen.
With Expose text option on, the stored or printed images will display text.
Expose Text is option set by the manufacturer.
Line 1
Line 2
Line 3
When a line has a check mark in front of it, it will be erased when Erase text line
is selected. Unchecked lines will not be erased.
To mark a line, select it with the CURSOR KEYS and then press SELECT.
By default, the three lines are not checked.
Applications
Select Applications and a second menu will appear on the screen.
Select application
Settings
Edit
Frequency
Select Application
Activate Select application to display the list of the available application presets.
From the factory, the scanner includes three standard presets: Default, Soft, and
Hard.
Use the cursor keys to select the preset and press SELECT to activate it. The
selected preset has a check mark in front of it.
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Settings
Activate Settings and the following menu will appear on the screen.
Upside down
Reverse
DNF
Dynamic range
Focus points
Autofocus
Autofocus zone
M Mode speed
Gray maps
When Upside down, Reverse, DNF, and Autofocus are on, they have a check
mark in front of them.
Upside down
Selecting Upside down will invert the image. Selecting this item again will
return the image to the original display.
Reverse
Selecting Reverse will reverse the displayed image. Selecting this item
again will return the image to the original display.
DNF
Selecting this item will switch on or off the Dynamic Noise Filter.
Dynamic range
Selecting Dynamic range will display a horizontal control bar. By using
the cursor keys the “receive” dynamic range can be adjusted to match the
current application. Please note total image gain may have to be
readjusted after selecting a new dynamic range setting.
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Focus points
Selecting Focus points will display a slider which allows the user to set
the number of focal points. Moving the left and right arrow keys adjusts the
number of points.
When the B mode image of the scanner is live, pressing the left and right
arrow keys adjusts the number of focal points.
The number of focal points for the three presets set from the manufacturer
are listed in the table below.
Autofocus
If Autofocus option is checked (indicating it is on), the system adjusts the
focal point(s) position automatically as the depth is adjusted.
If the Autofocus is unchecked (indicating it is off), the focal point(s)
position has to be adjusted manually by using the CURSOR KEYS (up and
down).
Autofocus zone
Selecting Autofocus zone will display a slider which allows the user to set
the zone of the image to focalize by Autofocus. The slider is adjusted by
using the CURSOR KEYS (up and down).
M Mode speed
The scanner needs to be in M-mode, selecting M Mode speed a slider will
appear at the bottom of the image.
Use the CURSOR KEYS to select the M Mode speed. When you have the
required sweep speed press SELECT to program this speed. There are 5
different speeds (1 - 5).
Gray Maps
The InViewTM offers digital grayscale conversion. There are 4
preprogrammed (Gray Map 1 – 4) and 2 user programmable gray maps
(Gray map 5 – 6). The gray maps influence the video grayscale, just
before the video output to the monitor.
Select Gray maps to choose the gray map of preference for the current
application.
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Edit
Activate Edit and the following menu will appear on the screen.
New application
Save application
Save application as
Rename application
Delete application
New application
To create a new preset, select New Application and a horizontal bar as
well as an alphanumeric keyboard will appear on the screen.
To name the preset, use the CURSOR KEYS to select letter(s). Use the
SET key to enter the individual letters in the horizontal bar. The maximum
number of characters that can be entered is 7. Once the preset name is
edited, press SELECT twice to confirm.
The maximum number of presets that can be created and stored in the
system is 10.
Save application
Select Save application to save the application settings under the current
preset (whose label is displayed on the screen).
Save application as
Select Save application as to save the settings under a new preset. The
original preset will be retained.
Rename application
A horizontal bar and an alphanumeric keyboard will appear in the screen.
Use the CURSOR KEYS and the SET key to rename the current preset.
Once the preset name is edited, press SELECT twice to confirm.
Delete application
Select Delete application to display a list of the programmed presets.
Select the preset to be deleted and press SELECT.
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Frequency
Selecting Frequency opens a sub-window including the following options:
Penetration
Generic
Resolution
Automatic
Frequency Description
Low frequency. This frequency is
Penetration
suitable for deep imaging
Medium frequency. This frequency is
Generic suitable for medium deep imaging
(3.3 – 4.4 cm)
High frequency. This frequency is
Resolution suitable for superficial imaging
(1.6 – 2.2 cm)
Automatic allows the system to set automatically the frequency according to the
selected depth. This is the default setting as programmed from the manufacturer.
Program
Selecting Program displays the following options list:
System Settings
Calliper Settings
Gray Maps
Macro
Installation
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System settings
Select System settings.
The System settings menu will be displayed on the screen:
Watchdog
Time
Date
Time Format
Date Format
Scale Format
Color
Watchdog (powersaver)
This function lets the user program the scanner to switch off completely or
to just switch the probe off. The user determines the amount of time the
unit is not in use before the watchdog activates.
Go to the System settings and select Watchdog and the following menu
will appear on the screen:
Off: The scanner will not go on standby or be switched off totally. Off is
the default setting of the Watchdog from the factory.
Analog Clock: The scanner will display an analog clock on the screen.
Digital Clock: The scanner will display a digital clock on the screen.
Standby: The scanner will go on standby switching the monitor off.
Scanner Off: The scanner will switch off.
Watchdog Time: The user is allowed to set the time for the watchdog
from a minimum of 1 minute up to maximum 15 minutes.
Or
Time format
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Using Time format the time display can be changed. Selecting Time
format will generate the following menu:
Date format
Using Date format the display of date can be altered. Selecting Date
format will give you the following menu:
MM/DD/YY
YY-MM-DD
DD.MM.YY
DD-MM-YY
DD/MM/YY
Color
Using Color (selectable in the menu through System Settings – Color),
the gray tone of the cross and the text displayed in the image can be
selected to be
White
Gray
Dark gray
Scale Format
Selecting Scale Format will generate the following sub-menu:
Digits
Central markers
If the Digits option is checked, then depth indications will be provided also
on the lateral scale, otherwise only the maximum display depth will appear
on the left side of the screen.
If the Central markers option is checked, then depth dots will be displayed
every 0.5 cm along the central line of the ultrasound image.
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Caliper settings
Return to the Program menu and select Caliper settings. The following menu will
appear on the screen:
Manual
Auto follow
Manual
In manual, the cross is positioned where the measurement is to
begin. Press the SET key. Move the cross to the next position
along the contour of the structure to be measured and press SET
again. Repeat these steps until you have described a complete
contour or length of the structure.
Auto follow
In auto follow, the cross is moved to the position where the
measurement is to begin. Press the SET key. Draw a
circumference of the structure or measure the length by moving
the cross.
Ellipse method
Select Ellipse method. The following menu will be displayed.
Axes
Points
From this menu choose whether to make the ellipse measurement through
axes or points.
Axes
Selecting Axes, an ellipse is automatically displayed upon drawing
the longest axis. The ellipse can be repositioned, re-sized and
rotated.
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Points
Selecting Points, an ellipse is automatically displayed upon
positioning 5 points along the outer border of the structure to be
measured.
Gray Maps
Return to the Program menu and select Gray Maps. The following menu appears
on the screen:
Gray Map 5
Gray Map 6
The vertical axis represents the gray-level on the monitor. The scale runs from
black at the bottom to white at the top.
If no display correction is required, a straight line must be drawn from the lower left
corner to the right top corner.
The result is that low reflections are represented as black on the image and high
reflections are represented by white.
An inverted image; however, is obtained by a line from the left top corner to the
lower right corner. Both these lines are called linear curves.
In some applications a non-linear (custom) curve is preferable. To draw such
curve is explained below.
You can define your own gray map by performing the following steps:
With the cursor keys, move the cross to the left side of the field and position it
where the gray map is to start.
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Press SET. A white square will appear in place of the cross; the displayed white
line immediately changes its position.
Move the cross slightly to the right and upward or downwards or at the same level
as the starting point and press SET again. A white square appears and the
position of the white line will change again.
Repeat the previous step until the complete gray map has been entered, shown by
the white line.
When the gray map has been completed, press the Select key in order to store the
gray map.
Place the cross on the white square and press SET. The white square will be
erased and the white line will change its position.
Removing all the squares erases the gray map.
In order to activate your gray map, select Applications from the main menu.
Select Settings. Scroll down to Gray Maps and select yours.
Macro
The scanner incorporates six Macros (shortcuts) which can be defined by the user
for quick execution of preprogrammed actions:
Macro 1
Macro 2
Macro 3
Macro 4
Macro 5
Macro 6
From the factory, the first three macros are used for:
• ID (permits the user to insert the patient ID or name)
• Preset (opens the window to select the application preset)
• Zoom (activates the Zoom mode)
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To insert selections from the normal menu structure, press SELECT to display the
Macro programming menu.
• Save and quit saves the requested action as a macro and quits the
Program menu.
• Quit quits the Program menu without saving the changes.
• Backspace deletes the last chosen action. The cursor will move 1 item to
the left.
• Clear clears all the contents of the Program window.
• Move attaches the Program window to the cursor keys in order to move it
to a different position on the screen and allow visualization of the underlying
image.
• Menu displays the main menu and allows access to the underlying levels
from which Macro actions can be retrieved.
Example: If the user wants to program the MACRO 5 to reverse the image
left/right.
1. Press SELECT, move the cursor to Program and press SELECT again.
2. Choose Macro from the menu, move to Macro 5 and press SELECT.
3. Edit the name to give to the macro (for example “Reverse”) and then press
SELECT.
5. Press SELECT, Menu, Applications, Settings, Reverse. This last action will
appear in the window.
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6. Press SELECT, Save and Quit. From this point on the Macro 5 will reverse the
image left/right.
Installation
Return to the Program menu and select Installation. The Installation menu will
be displayed on the screen:
Selecting Yes: The original manufacturer settings will be installed (All the
programmed settings will be erased).
Measurement unit
A new menu will be displayed:
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cm
inch
The user is allowed to choose how the scale-bar on the screen and the
measurements are to be expressed (centimeters or in inches).
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Measurements
This chapter will explain the procedures to perform measurements in all the different
image modes.
To make measurements the following keys are used:
SET key
When you press the SET key the image will freeze automatically and the
measurement mode is initialized.
While in measurement mode, a cross appears on the screen. To move the cross
use the CURSOR KEYS.
Press SET to set the position of the cross.
To select a different measurement mode, press the SET key before moving the
cross.
Multi
When the measurement mode is on, the Multi function appears next to the software
configurable key .
Multi lets a new measurement to be performed without losing the result of the previous
measurement (which is displayed inside a bar at the bottom of the screen).
After the second cross has been placed by the CURSOR KEYS, press the
SOFTWARE CONFIGURABLE KEY (Multi).
The measurement just performed will remain on the screen while a new caliper
symbol will appear on the screen.
If a different type of measurement is desired, press repeatedly SET to select it.
Proceed to performing the measurement as described in the following sections.
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B Mode Measurements
Distance
Distance measurement is between two points in a straight line. Press the SET key once or
repeatedly until the distance measurement is displayed.
The first caliper cross appears on the screen.
Move the cross with the cursor keys to the desired position.
Press the SET key to fix the first cross.
Press the cursor keys. A second cross can be positioned at the second position.
DO NOT press SET again. If you do, the measurements taken are lost.
The distance is displayed on the left of the screen.
Move the cross with the cursor keys to the desired position.
Press the SET key to fix the first cross.
Then draw a contour along the structure with the cursor keys. This contour can be
drawn in two ways depending on the measurement type, active at that moment:
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Move the cross with the cursor keys to the desired position.
Press the SET key to fix the first cross.
Draw a circumference along the structure with the cursor keys. This circumference
can be drawn in two ways depending on the measurement type active at that
moment:
Ellipse (Area/Circumference/Volume)
Area, Circumference and Volume are measured simultaneously with the Ellipse
measurement method.
The Area, Circumference and Volume can be measured using the five points method or
using the indication of long axis method.
5 points Method
Press the SET key repeatedly until the Ellipse measurement is displayed.
The first caliper cross appears on the screen.
• Move the cross with the cursor keys to the desired position.
• Press the SET key to fix the first cross.
• Move the cross with the cursor keys to the next desired position. Press the SET key to fix
the second cross.
• Repeat until five points have been set.
• Now an ellipse through the five points will automatically be displayed.
• The results are displayed at the left side of the screen.
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Move the cross with the cursor keys to the desired position.
Press the SET key to fix the first cross.
Draw a straight line along the long axis of the structure.
Press the SET key to fix the second cross.
An ellipse with a small area is drawn automatically.
Change the area of the Ellipse with the cursor keys.
The result is displayed at the left side of the screen.
The position, size and rotation of the ellipse can still be changed by pressing the SET key
again. When SET is pressed, an icon will appear for few seconds in the left top corner of
the screen and indicate which of the variables position, size or rotate is controlled with the
cursor keys.
Angle
Press the SET key repeatedly until the angle measurement is displayed.
The first cross appears on the screen:
Move the cross with the cursor keys to the position where the angle should be
measured.
Draw a straight line along one of the axis of the angle.
Press the SET key to fix this line.
Move the CURSOR KEYS. A second line will be visible. Put this line along the other
axis of the angle.
The result is displayed at the left side of the screen.
M Mode measurement
The following measurements are available for M Mode:
Distance: Distance measurement between two points.
Time: Time measurement between two points on the M trace.
Velocity: Ratio between Distance and Time.
Heart rate: Heart beat rate calculated through two peaks.
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General Information
This section provides some information and warnings for the use of the InViewTM scanner
during vascular access procedures.
The user should follow hospital/institution policies and procedures for ultrasound guided
vascular access procedures with attention to the following recommendations:
• Do not re-use single use products including but not limited to sterile
ultrasound gel, sterile cover, elastic band, and needles.
• Identify latex sensitive patients before the exam. Serious allergic reactions to
latex have been reported and you should be ready to react accordingly.
• Pay attention to the ultrasound image during the insertion of the needle in the
body. Be sure to verify that the needle follows the desired path to reach the
target vessel and avoids other vessels or structures adjacent or close by.
• Use sterile tools and instruments during the examination when required.
• Assure that the probe is made sterile and prepared as described in the
section below for sterile procedure.
Probe Preparation
1. Make sure the probe is disinfected. Follow the recommendations for probe cleaning
and disinfection in this manual as well as the instructions from the manufacturer of
the disinfecting solution.
2. Apply sterile coupling gel on the lens.
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3. Place the sterile cover on the probe and use the components in the sterile cover kit
to secure it in place. Remove any folds of the sterile cover and air bubbles over the
lens to optimize the ultrasound propagation through the cover.
4. Apply sterile coupling gel on the cover (over the lens part of the probe) or on the
skin of the patient on the area of investigation.
The image quality can be improved by adjusting the Depth and Frequency settings as well
as the overall gain in order to get the ideal display of the specific vessel to be visualized.
To assist the user, the InViewTM probe has a gray arrow marker positioned at the center of
the lens. A dotted line is present on the screen at the center of the image (the dots are 0.5
cm apart to aid in determining the depth). The marker on the probe corresponds to the
center of the image or the central dotted line.
It is suggested that the user utilizes the central dotted line on the screen as a reference
point while performing vascular access procedures.
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Remove loose dust from the exterior with a soft cloth or a dry brush.
A solution of water with a mild detergent may be used. Avoid abrasive cleaners.
Check the ventilation fan of the unit for proper operation. The fan will be intermittently
active and audible.
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Products that contain the following chemicals are known to damage the probe:
Acetone
Methanol
Denatured ethyl alcohol
Mineral oil
Iodine
Any lotions or gels containing fragrance
Check with the ultrasound gel manufacturer regarding gel contents. If you have additional
questions, please contact the local representative.
Scrub the probe with your hands with water or with water and mild detergent. Use a
dampened soft cloth or towel. Never use an abrasive sponge.
Dry the transducer by gently rubbing it with a soft, dry cloth.
Probe Disinfection
Disinfect the probe using CidexTM Activated Dialdehyde Solution according to the
manufacturer’s directions.
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Probe Sterilization
No sterilization methods have been tested directly on the probe for the InViewTM scanner.
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Other
For proper use of the probe the following additional items are necessary:
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NOTE: When the ultrasound scanner is intended to be used in a sterile environment, use a
sterile coupling gel.
Sterile Covers
The cover tested with the probe of InViewTM is:
• Civco 610-542 Sterile 14x91.5cm (5.5" x 36") CIV-Flex cover (3D end)
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FDA Tables
Acoustic output reporting table for Track 1
Non-Autoscanning mode
System: InViewTM
Part nr: 411323
SN: 05020017
Application(s): C1.3
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System: InViewTM
Part nr: 411323
Sn: 05020017
Application(s): C1.3
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System: InViewTM
Part nr: 411323
Sn: 05020017
Application(s): C1.3
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TIS TIB
Index Label MI non-scan non- TIC
scan
Aaprt≤1 Aaprt>1 scan
Note:
(a) This probe is not intended for transcranial or neonatal cephalic uses
(#) No data are reported for this operating condition since the global maximum index
value is not reported for the reason listed.
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Specifications
GENERAL INFORMATION
Technical specifications of the scanner
Connections
Power input 10.5-13.5V DC connects instrument to operating power.
Video OUT Video output terminal for video recording, printing or external monitor.
Standard CCIR/PAL or EIA/NTSC video.
Communications Bi-directional infrared port.
General specifications
Power Battery pack or external power, consumption 18VA
Battery pack 12 Volt DC rechargeable NiMh, 4.4 Ah.min
External power Use only specified Esaote Europe Equipment power adapter
(Art # power adapter: 97154 411038)
Probe type Linear array 20mm 10-5 MHz
Scanning method Linear
Max image depth 44 mm
Post processing 4 fixed and 2 user programmable gamma correction curves
Dynamic range Max. 55dB, programmable
Measurements Multifunctional measurement system, able to measure Distance,
Length, Area, Volume, Circumference, Angle, Time, Speed.
Display format 5.0 inch scale TFT LCD, resolution 320(H)*234(V)
Gray shades 256
Weight 1000 grams without battery (2.2 lbs.)
Dimensions W*D*H=15.5*12*13 cm
Rating probe IPX-7, not suitable for use in the presence of a flammable anaesthetic
mixture with air or with oxygen or nitrous oxide.
Enclosure and Within specification for class II type CF according to IEC60601-1
leakage current
Environmental Temperature 8 ÷ 40 °C (46,4 ÷ 104 °F). Humidity up to 95% (at 40 °C /
104 °F).
Operating
Conditions
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