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USER MANUAL

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

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InViewTM User Manual

MANUAL UPDATE SHEET


Attached is a complete version of the InViewTM User’s manual.
All pages carry the same version number: 05B46EN01.
If there is an update for this version, please remember to recycle the
replaced pages.

U.S.A.: Federal law restricts this device to use by or on the order of a physician.

The device configuration is listed in the attached configuration list.

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InViewTM User Manual

Device Configuration List InViewTM

Unit and probe

Article # Description

97154 411323 InViewTM basic configuration in transport case with the


following items:
• Scanner with “InViewTM” keyboard and L20 probe hardwired to
the unit
• 2 Battery Packs
• 1 Battery Charger
• User manual
• 1 Bottle of Gel
• 1 Roll Stand Adapter

Options

Article # Description
97154 410057 Battery Pack¹)
97154 411227 Communication Package
97154 411267 Battery Charger³)
97154 411038 Mains Supply²)
97154 411102 Roll Stand Adapter

¹) originally labeled: Manufactured by Esaote Europe, Philipsweg 1, 6227AJ Maastricht,


The Netherlands

²) originally labeled: Hitron Electronics Corporation, model HES49-12040-7


incl cable,(medical grade power cord).

³) originally labeled: Fast Battery Charger, Manufactured Mascot Norway


Incl. Cable, (not medical grade power cord)

Version: 05B46EN01 i
InViewTM User Manual

To order please contact:


Arrow International
2400 Bernville Road
Reading, PA19605 USA
Tel. 800-523-8446
(+1) 610-655-8522

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InViewTM User Manual

Explanation of Symbols

Symbol Description

Equipment conforms to IEC60601 Type CF requirements for


medical electrical equipment.

Video Output.

Refer to the user manual before activation of the unit.

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InViewTM User Manual

Table of Contents

Intended Clinical Use and Safety Information.............................................1


Safety information .............................................................................................................2
Electrical Safety ..............................................................................................................................................2
Electromagnetic Compatibility.........................................................................................................................2
Warnings and Precautions..............................................................................................................................3
Precautions .....................................................................................................................................................5

System Content and Set Up ..........................................................................7


Contents of the Package ...................................................................................................7
Options............................................................................................................................................................7
Inspection of the InViewTM ..............................................................................................................................8
Rear panel of the InViewTM: ............................................................................................................................8

Preparing the examination environment ....................................................................... 10


Should you still have problems starting up the system, please contact Arrow
International. .................................................................................................................... 10
How to attach the InViewTM to the roll stand ................................................................. 10
How to get started ........................................................................................................... 10
Operating in a Sterile Environment................................................................................ 11
Control Panel & Screen Information ..........................................................12
The Keypad...................................................................................................................................................12
The direct operating keys..............................................................................................................................14
The Screen....................................................................................................................................................16
Optimize image presentation ........................................................................................................................17
Probe Frequencies........................................................................................................................................17
Video processing ..........................................................................................................................................17

System and Application Settings ...............................................................18


System settings ............................................................................................................... 18
Application settings ........................................................................................................ 19
Reinstalling manufacturer’s default settings ................................................................ 20
Main Menu ....................................................................................................21
Image modes.................................................................................................................... 21
B Mode ..........................................................................................................................................................21
Double B Mode .............................................................................................................................................21
B + M Mode...................................................................................................................................................22
M Mode .........................................................................................................................................................22
Zoom .............................................................................................................................................................22

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Macros (Shortcuts) .......................................................................................................... 23


Save/Recall image ........................................................................................................... 23
Image to disk.................................................................................................................................................23
Image from disk.............................................................................................................................................24
Delete from disk ............................................................................................................................................24
Format disk ...................................................................................................................................................25
Format disk ...................................................................................................................................................25

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

About the scanner ........................................................................................................... 38


Measurements..............................................................................................39
B Mode Measurements.................................................................................................... 40
Distance ........................................................................................................................................................40
Length (manual/auto follow)..........................................................................................................................40
Area/Circumference (manual/auto follow) ....................................................................................................41
Ellipse (Area/Circumference/Volume)...........................................................................................................41
Angle .............................................................................................................................................................42

M Mode measurement ..................................................................................................... 42


Vascular Access Procedure........................................................................43
General Information ......................................................................................................................................43
Probe Preparation .........................................................................................................................................43
Use of the Scanner .......................................................................................................................................44

Cleaning, Disinfection and Maintenance ...................................................45

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Handling and Care ........................................................................................................... 45


Probe Warnings and Precautions .................................................................................. 45
Products and procedures that may damage the probes...............................................................................45

General probe cleaning ................................................................................................... 46


Probe Disinfection ........................................................................................................... 46
Probe Sterilization ........................................................................................................... 47
Cleaning of the Scanner.................................................................................................. 48
Cleaning of the battery .................................................................................................... 48
Cleaning of the protective case...................................................................................... 48
Cleaning of the roll stand................................................................................................ 48
Ultrasound coupling gel.................................................................................................. 49
Sterile Covers................................................................................................................... 49
Acoustic Output Information ......................................................................50
FDA Tables ....................................................................................................................... 50
Specifications...............................................................................................54

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Intended Clinical Use and Safety Information

The following table lists the intended clinical use of the InViewTM and its integrated probe.

Art.# Type Probe Indications for use


97154 411323 InViewTM Linear 20 mm Peripheral vascular
configuration 10- 5 MHz Small organs
Musculoskeletal (conventional and
superficial)
Intra-operative (abdominal, vascular)

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.

Small Organs and Musculoskeletal (Conventional and Superficial)


This system transmits ultrasound energy into the various parts of the body to obtain 2D
and M Mode images of normal structures and some pathologies of the breast, thyroid,
superficial soft tissue, shoulder joints, wrist, ankle, and knee, which can be used to assess
the presence and extent of some diseases and injuries.

Intraoperative (abdominal and vascular)


This system transmits ultrasound energy into the various parts of the body using 2D and M
Mode imaging to obtain ultrasound images that provide guidance during interventional and
intra-operative procedures. This system can be used to provide ultrasound guidance for
biopsy and drainage procedures, and provide assistance during abdominal and vascular
intraoperative 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).

The use of ACCESSORY equipment not complying with the


equivalent safety requirements of this equipment may lead to a
reduced level of system safety.
- Use of the accessory in the PATIENT VICINITY:
Evidence that safety certification of the ACCESSORY is in
accordance with the appropriate IEC60601-1/IEC60950 and/or
IEC60601-1-2 harmonized national standard.

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:

ƒ Relocating the system


ƒ Increasing the separation from other devices
ƒ Powering the ultrasound system from an outlet different from the one of interfering device
ƒ Contacting service personel for help

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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Guidance and manufacturer’s declaration – electromagnetic emmisions


The InView is intended for use in the electromagnetic environment specified below.
The customer or the user of the InView should assure it is used in such an enviroment.

Emmisons test Compliance Electromagnetic environment guidance


RF emissions Group 1 The InView uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment
RF emissions Class A
CISPR 11 The InView is suitable for use in all establishments
other than domestic, and may be used in domestic
Harmonic emissions Not applicable establishments and those directly connected to the
CISPR 11 public network that supllies buildings used for domestic
IEC 61000-3-2 purposes, provided the following caution is heeded:
Voltage fluctuations/ Not applicable
flicker emmisions Caution: This equipment/system is intended for use by
IEC 61000-3-3 healthcare professionals only. This is a CISPR 11 Class
A medical equipment/system. In a domestic
environment tis equipment/system may cause radio
interference, in which case it may be necessary to take
adequate mitigation measures, such as re-orienting,
relocating or shielding the InView or filtering the
connection to the public mains network.

Warnings and Precautions

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

qualified personnel only.

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‰ If the ultrasound equipment or other devices are defective, there is a risk of


electrical shock. Be careful not to place the patient into contact with the ultrasound
equipment or other devices.
‰ The use of non-Esaote Europe components with this scanner may result in damage
to Esaote Europe components.
‰ To prevent hazards, refer to your local requirements for adequate electrical
installation in case of class II type CF equipment.
‰ Do not subject the equipment to excessive mechanical shock, for example, when
moving the equipment. If the equipment is repeatedly subjected to excessive
mechanical shock, mechanical parts may be damaged.
‰ The manufacturer, assembler, installer or importer considers himself responsible for
the effects on safety, reliability and performance of this product only if:
o Assembly operations, extensions, re-adjustments, modifications or repairs are
carried out by authorized personnel.
o The electrical installation of the relevant room complies with the IEC
requirements.
o The product is used in accordance with the instructions for use.
‰ While there is no danger to a patient with a pacemaker, ultrasonic scanning
equipment could cause mechanical damage to the pacemaker if used directly over
the device's implant site.
‰ Do not use the equipment in locations subject to intense electric or magnetic fields
(near transformers, for example).
‰ Do not use the equipment near devices generating high frequencies (such as
medical telemeters and cordless telephones). If used near such devices, the
equipment may malfunction or adversely affect such devices.
‰ To guarantee proper unit operation do not operate the scanner in an environment
with a temperature in excess of 8-40 °C (46.4 – 104 °F).
‰ Avoid use and storage near a heater or in direct sunlight. For correct image
contrast, only TFT-LCD screens properly adjusted by the manufacturer may be
used on the scanner.
‰ Inspect the probe carefully if dropped or strikes hard surface. If it appears damaged,
remove from use.
‰ See detailed instructions how to clean the probe in this manual.
‰ The LCD screen is fragile and must be handled accordingly.

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‰ Electromagnetic compatibility.

This system complies with the EN60601-1-2. It is a class A device.

This is a class A product. The product is suitable


for use in all establishments other than domestic.
This product is also allowed in domestic
establishments under jurisdiction of a health care
professional (according IEC60601-1-2 clause
36.201.1).

‰ A warning is displayed to the operator when the internal temperature is equal or


higher than: 60 °C (140 °F).

In the case of high temperature message


displayed on the screen, the user has to end the
examination as soon as possible.

‰ 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:

Do not open, throw in fire, heat, or short circuit.


Charge only with provided charger.
Do not use the battery pack in any other devices
than specified.
Do not connect directly to a power outlet.
Be sure to charge the battery within a temperature
range of 8 to 40 °C.
Storage temperature: min -20 °C / -4 °F
max 60 °C / 140 °F.
Storage pressure: 700 – 1060 hPa (10.2 – 15.4psi)

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.

In the case of battery low charged message


displayed on the screen, the user has to end the
examination as soon as possible.

The battery pack contains a rechargeable nickel


metal hydride battery. DO NOT dispose of it in
water, fire, or solid waste landfill. Federal and
local laws may apply to the disposal of this
battery.

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System Content and Set Up

Contents of the Package


The package of the InViewTM consists of the following:

• Scanner and probe hardwired to the unit


• 2 Batteries (cable included)
• Battery charger and travel kit
• User manual
• Bottle of gel

Options

Article # Description

97154 410057 InView™ Battery Pack ¹)

97154 411227 InView™ Communication Package

97154 411038 InView™ Mains Supply ²)

97154 411267 InView™ Battery Charger ³)

97154 411102 InView™ Roll Stand Adapter

¹) originally labeled: Manufactured by Esaote Europe Equipment, Philipsweg 1, 6227AJ


Maastricht, The Netherlands

²) originally labeled: Hitron Electronics Corporation, model HES49-12040-7


incl cable,(medical grade power cord).

³) originally labeled: Fast Battery Charger, Manufactured Mascot Norway


Incl. Cable, (not medical grade power cord)

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InViewTM Set Up

Inspection of the InViewTM


Upon opening the shipping box check the transport case, the probe (housing, cable and
connection) and the scanner for damage.

Rear panel of the InViewTM:

Power connection Video output Probe cable

Outlet Freeze button (not


applicable with this unit)

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:

The grounding and enclosure leakage currents of


the system in combination with the VCR or Image
Copier may not exceed the leakage limits for
IEC60601-1 publication class II equipment safety
type CF.

To prevent hazards refer to your local requirements for adequate electrical installation.

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Preparing the examination environment


The scanner may be battery operated or connected to the mains supply as described at
the beginning of this section of the manual.
If the scanner fails to start up, the cable connections should be checked. If a subsystem,
such as a video printer, is not working, check its power connection, power switch and
signal connection lead.

Should you still have problems starting up the system, please contact Arrow
International.

How to attach the InViewTM to the roll stand


1. Place the scanner on top of the mounting plate of the scanner holder from the
rolling stand.
2. Slide the tabs on one side of the plate into their inserts at the back of the scanner.
3. Use the screws at the other end of the plate to attach the plate to the scanner.
4. Connect the scanner to the power source (battery or mains supply).
5. When the scanner is properly attached to the mounting plate, the user is allowed to
adjust the position of the InViewTM vertically or horizontally by rotating the rolling
stand.

How to get started


- Install the scanner on its own roll stand.
- Verify that the scanner is properly connected to a InViewTM power source (battery or
Mains supply) and that the peripherals (printer, VCR) are properly connected.

When the InViewTM is delivered, the batteries are


completely empty.
Hence, before supplying the InViewTM by battery,
the batteries have to be charged by the battery
charger provided with the InViewTM.
The battery should be charged outside the patient
environment

- Switch on the scanner.


- Apply coupling gel to the probe lens surface or to the patient’s skin.
- If the scan’s image quality is not satisfactory, adjust the depth, overall gain and
frequency.

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Operating in a Sterile Environment


If the scanner is intended to be used in a sterile environment, the system probe should be
prepared as follows:
- Apply sterile coupling gel to the probe lens surface.
- Place the probe into a sterile sheath.
- Fix the sheath on the probe with the supplied elastic bands. Note: no sheath folds
or air bubbles should be visible on the lens.
- Apply sterile coupling gel to the sheath (the part in contact with the lens of the
probe) or onto the patient’s skin.
- If the scan’s image quality is not satisfactory, adjust the depth, overall gain and
frequency.

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Control Panel & Screen Information

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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The direct operating keys.


Direct operating keys are frequently used during an examination.

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.

SOFTWARE PROGRAMMABLE KEY

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

These keys can be used to:


o Change the position of the cursor
o Change the position of the caliper cross
o Move through the menu
o Adjust the number of focal points and their position

STORE

This key stores the displayed ultrasound image into the memory of the unit.

GAIN adjustment keys

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...

Depth scale & focus points


Two methods of providing depth information are available according to the setting in the
main menu.
1. A scale format indicates the displayed depth.
2. The display depth is shown on the left side of the screen and a scale is displayed
both on the left side and in the central part of the image with marks. An arrow
indicates the actual focus point position.

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

Optimal image resolution


The focus setting influences the resolution.

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.

Optimize image presentation


Always try to optimize the image with the total gain keys of the scanner.

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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System and Application Settings

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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System settings are software version dependent,


and are not guaranteed to be functional between
software versions.

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.

How to create/configure an application preset:


To add a new preset to the system, follow the three step process described below.

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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How to update an existing application preset:


To update an existing application preset proceed following the steps below.

1. Load the application preset to update by Applications – Selection Application.


2. Set the settings of the system during the normal use of the InViewTM.
3. Save the new settings under the current application preset by Applications – Edit –
Save Application.

Application settings are software version


dependent, and are not guaranteed to be
functional with software versions.

Reinstalling manufacturer’s default settings


To return the scanner back to the manufacturer’s default settings, use the menu item
Program – Installation - Install default. This will return the scanner back to its original
shipping state. All previous system settings and application settings will be lost.

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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.

The active image can be frozen by pressing the FREEZE key.


The word FREEZE in the status field will be highlighted when the image
is frozen.

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

The M Mode sweep speed can be altered as explained above.

Zoom
Zoom can be activated when the scanner displays a single live B Mode image.

• Press the Macro key , select Zoom and press SELECT


• The zoom box will appear on the screen
• Press DEPTH to resize the zoom box and use the CURSOR KEYS to move it
on the 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.

Image Depth (cm) Zoom Box


Repositionable Box Sizes (cm)
1.6 No -
2.2 Yes, up and down 2 x 1.6
3.3 Yes, up and down 2 x 1.6, 2 x 2.2
2 x 1.6, 2 x 2.2,
4.4 Yes, up and down
2 x 3.3

• Press the Macro key to zoom in the image


• When the zoom is on, the position of the zoomed image can still be adjusted
by using the CURSOR KEYS

• Press the Macro key to switch the zoom off

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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Image from disk


Select this item and another menu will appear. Depending on how many images
there are stored and on which dates, the menu can look like the following:

[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

Delete from disk


Select this item and another menu will appear. Depending on how many images
there are stored and on which dates, the menu can look like the following.

[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.

With the InViewTM communication package it is


possible to transfer images from the InViewTM to
the PC. Please contact your Arrow International
sales representative or Arrow International
directly in order to obtain this package. The
InViewTM communication package includes an
instruction manual how to install the package and
how to transfer the images to the PC.

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.

Erase text line


Selecting Erase Text line allows the user to delete the information entered into
the Line fields.
Selecting Erase Text line deletes only the lines that are selected under Erase
text option.

Erase text option


Erase Text option allows the user to define which lines must be deleted when
Erase Text line is selected.
To perform the selection of the line(s) to delete, select Erase Text option. The list
below appears:

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.

Preset Focal points number


Default 1
Soft 3
Hard 3

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.

A horizontal bar and an alphanumerical keyboard will appear in the


screen.
Use the cursor keys to select a letter and use the SET key to enter the
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.

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

Penetration, Generic, and Resolution set a frequency.

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.

Time & date


Select Time or date in this menu. A new menu appears:

Time (HH : MM : SS) : 14 : 52 : 03

Or

Date (YY - MM- DD) : 03- 02- 14

A small alphanumerical keyboard will also appear on the screen.


Using the cursor keys and the set key (for confirmation) a new Time or
date can now be entered.
The time and date are displayed in the left top corner of the screen.

Time format

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Using Time format the time display can be changed. Selecting Time
format will generate the following menu:

HH:MM:SS (Time is displayed in 24 hour format)


HH:MM AM/PM (Time is displayed in 12 hour format)

Activate the Time format of your choice.

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

Activate Date format of your choice.

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

The criterion is the average brightness of structures to be visualized. If


images in which measurements are to be taken are often light, a darker
cursor may be selected to make it more visible.

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:

Length, Area/Circumference method


Ellipse method

Length, Area/Circumference method


Selecting Length, Area/Circumference method displays the following
menu on the screen:

Manual
Auto follow

From the menu, choose whether performing the Length,


Area/Circumference method measurement by manual or 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

Select Gray Map 5 or Gray Map 6.


The following curve appears on the screen:

A Gray Map translates an input signal to an output signal according to a curve.


On the graphical representation the horizontal axis represents the received signal
from the probe, where a high reflection gives high amplitude and low reflection low
amplitude. The scale runs from left for low levels to right for high levels.

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.

The programmed curve can be changed back manually as follows:

‰ 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.

The gray map can be programmed under an


application (preset).

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)

In general all actions or sequence of actions to be performed with menu selections


can be programmed under one single key; Macro.
A macro is programmed as follows:
• Press SELECT to display the Main menu.
• Select Program from the Main menu and press SELECT again. The
Program menu will now appear.

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• Select Macro from this menu.


• When the Macro menu is displayed, move the cursor to the Macro to be
programmed and press SELECT.

A Macro will be marked with a √ when that particular Macro is already


programmed. An empty window will be displayed at the bottom of the screen.
Keys selected via the menu selections will appear in this window and are part of
the Macro.

To insert selections from the normal menu structure, press SELECT to display the
Macro programming menu.

Save and Quit


Quit
Backspace
Clear
Move
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.

4. The Program window appears.

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.

How to use a Macro


In order to activate a Macro, press the “Macro” key on the left side of the
keypad.
The list of the programmed macros will be displayed.

Select the corresponding macro to activate the programmed item.

How to delete a Macro


In order to delete a Macro, follow the procedure below:
• Press SELECT to enter the main menu
• Select Program and press SELECT
• Select Macro and press SELECT
• Select from the list the macro you want to delete and prss SELECT
• Press SELECT twice without editing any character
• Press SELECT to open the Macro programming menu
• Select Clear and press SELECT
• Press SELECT, select Save and quit and press SELECT

Installation
Return to the Program menu and select Installation. The Installation menu will
be displayed on the screen:

Install default settings


Measurement unit
Extern video standard

Install default settings


Select Install default settings. The following menu appears:

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).

Extern video standard


This option sets the system to CCIR (PAL 50 Hz) or EIA (NTSC 60 Hz).

About the scanner


Select About the scanner and a second menu will appear on the screen.
This menu contains information for the service engineer, for instance, the software release
number and date. Use the up and down cursor keys to scroll through the information
window.

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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.

A maximum of 5 measurements can be simultaneously displayed on the screen by Multi.

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B Mode Measurements

The following measurements are available in B Mode:


Distance (D): Distance measurement between two points.
Length (L): Length measurement of a curve.
Area/circumference (A and C): Area and Circumference.
Ellipse (A, C and V): Area, Circumference and Volume.
Angle: Angle measurement.

The Measurements can be activated with the SET key sequentially.


The Measurements are listed in the following order: Distance, Length,
Area/Circumference, Ellipse, Angle.
The active measurement mode is displayed on the left side of the screen.

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.

Length (manual/auto follow)


Length measurement is a measurement along a curved line. The length measurement can
be performed manually or auto follow. The measurement type can be selected and
programmed through menu selection (refer to Program – Caliper settings – Length,
Area/Circ. Method).
Press the SET key repeatedly until the length measurement is displayed.
The first 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.
‰ 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:

1. Manual: Drawing a contour is performed by repeatedly pressing the SET key


and moving the cross with the CURSOR KEYS.
2. Auto follow: Drawing a contour is performed by positioning the cross to the
correct position. Press the SET key and draw a contour with the CURSOR
KEYS.

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‰ The result is displayed on the left of the screen.

Area/Circumference (manual/auto follow)


Area/Circumference is measured simultaneously. The Area/circumference
measurement can be performed manually or with auto follow. The measurement type can
be selected and programmed (refer to Program – Caliper settings – Length, Area/Circ.
Method).
Press the SET key repeatedly until the (first) Area/circumference measurement is
displayed. The first 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.
‰ 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:

1. Manual: Drawing a circumference is performed by repeatedly pressing the SET


key and moving the cross with the CURSOR KEYS.
2. Auto follow: Drawing a circumference is performed by positioning the cross to
the correct position. Pressing the SET key and drawing a circumference with the
CURSOR KEYS.

‰ The result is displayed at the left side of the screen.

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.

To change the Ellipse measurement method: go to Program - Caliper settings - Ellipse


method, and choose between Axes or Points.
This setting is saved as a system setting.

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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Indication of Long Axis Method


Press the SET key repeatedly until the Ellipse measurement is displayed.
The first 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.
‰ 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.

‰ Press the SET key to start the measurement mode.


‰ The M Mode measurements appear at the left side of the M Mode image and the
cross appears on the image.
‰ Use the CURSOR KEYS to place the first cross.
‰ Press SET to fix the position of the first cross.
‰ Use the CURSOR KEYS to place the second cross.
‰ As the second cross is being moved, the values of distance, time, velocity, and
heart rate are updated on the left side of the screen.

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Vascular Access Procedure

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:

• These devices (vascular access catheters, needles, and accessories) should


be used only by clinicians experienced or trained in the implantation of
vascular access devices and knowledgeable of the risks.

The use of needles and catheters involves


inherent risk.

• 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.

Use of the Scanner


The InViewTM scanner provides ultrasound images of the vascular structures and organs to
help the healthcare users before and during the vascular access procedures.

Arrow International and Esaote Europe cannot be


considered responsible for the results on the
patients and the outcomes of the procedures.
These remain the responsibility of the user
performing the examination.

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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Cleaning, Disinfection and Maintenance

Handling and Care


Although the scanner is produced with the utmost care and only the highest quality
components are used, maintenance will be necessary from time to time to ensure trouble-
free operation.
Contact your Arrow International sales representative for service options.

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.

Probe Warnings and Precautions


Always follow these basic precautions:

‰ Inspect the probe daily for cracks and other damage.


‰ DO NOT use a probe that has been cracked or damaged.
‰ DO NOT use a probe that has been dropped or struck against another object until it
is inspected by a service engineer.
‰ Avoid pinching or kinking the probe cable. If the probe housing becomes cracked or
broken or if there are cuts or openings in the probe cable the electrical safety of the
probe could be compromised.
‰ Switch the system off before cleaning and disinfecting.

Products and procedures that may damage the probes


Some products and procedures damage probes. Use of any of the following products or
procedures WILL VOID your probe warranty.

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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.

The following procedures are known to damage probes:


‰ Autoclaving
‰ Soaking the probe in chlorine bleach

High-level disinfect the probe ONLY by soaking in


the recommended liquid germicide. Other
methods are NOT allowed and could damage the
probe, voiding your warranty.

General probe cleaning


Cleaning the probe is done by first removing the ultrasound coupling gel with a soft tissue
and then gently wiping the probe dry using a new tissue or dry cloth.
If the probe is very dirty do the following:

‰ 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.

CidexTM Activated Dialdehyde Solution


Advanced Sterilization Products,
A Johnson & Johnson Company
P.O. Box 90130
Arlington, Texas 76004-3130
Telephone: 800-595-0200
www.cidex.com

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Probe Sterilization
No sterilization methods have been tested directly on the probe for the InViewTM scanner.

Use the recommended liquid germicides for a time


sufficient to reach a high-level disinfection
(according to the instructions from the
manufacturer of the disinfecting solution).
Other methods and longer times of exposure are
NOT allowed and could damage the probe.

Although the probe is rated IPX-7, it’s


recommended to immerse the probe case only to
the point where there is a 1 cm space between the
water level and the cable (see drawing below). The
probe is not watertight and immersion can
compromise its electrical safety features.

Always follow these basic precautions for


cleaning and high level disinfecting:
‰ DO NOT soak the probe in alcohol. Alcohol is
nearly inactive against certain organisms.
‰ DO NOT rub the probe with an abrasive sponge
when washing with soap and water. Use a soft
cloth or towel.

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Cleaning of the Scanner


‰ Wipe the scanner gently using a clean tissue or dry cloth.

If the scanner is unclean, do the following:

‰ Wipe the scanner gently with a dampened cloth.


‰ Wipe the scanner dry with a towel.
‰ To disinfect the scanner mildly, use a cloth dampened with 70%, or less, alcohol
solution. Do not soak the scanner in an alcohol solution.

Cleaning of the battery


‰ Wipe the battery gently dry using a new tissue or dry cloth.

If the battery is unclean, do the following:

‰ Wipe the battery gently with a dampened cloth.


‰ Wipe the battery dry with a towel.
‰ To disinfect the battery mildly, use a cloth dampened with 70%, or less, alcohol
solution. Do not soak the battery in an alcohol solution.

Cleaning of the protective case


If the protective case is dirty use a dampened cloth to wipe the case clean.

Cleaning of the roll stand


‰ Wipe the roll stand gently using a clean tissue or dry cloth.

If the roll stand is unclean one can do the following:

‰ Wipe the roll stand gently with a dampened cloth.


‰ Wipe the roll stand dry with a towel.
‰ To disinfect the roll stand mildly, use a cloth dampened with 70%, or less, alcohol
solution. Do not soak the roll stand in an alcohol solution.

Other
For proper use of the probe the following additional items are necessary:

‰ High level disinfection solution (Use recommended brand only).


‰ Ultrasound coupling gel.
‰ Sterile cover (when the probe is intended to be used in a sterile environment).

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Ultrasound coupling gel


Use an ultrasound coupling gel to prepare the probe for an exam.
The gel recommended for use with the InViewTM Ultrasound system is Aquasonic 100
manufactured by Parker Laboratories, 286 Eldridge Road, Fairfield, New Jersey 07004,
USA. Telephone – 800-631-8888 and cleared by FDA via K802146.

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)

CIVCO Medical Instruments


102 First Street South
Kalona, IA 52247-9589
Tel: 800-445-6741
www.civco.com

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Acoustic Output Information

FDA Tables
Acoustic output reporting table for Track 1
Non-Autoscanning mode

System: InViewTM
Part nr: 411323
SN: 05020017

Transducer Model: Probe human L 10-5 20mm


Partnr: 311492
SN: 50448010

Application(s): C1.3

Operating mode: M Mode

Acoustic Output MI ISPTA.3 ISPPA.3


[-] [mW/cm2] [W/cm2]
Maximum Value 0.96 36.20 255
Associated Pr.3 [MPa] 2.20
Acoustic W0 [mW] 0.60 0.50
Parameters fc [MHz] 5.30 5,30 6.60
Zsp [cm] 1.10 1.10 1.50
Beam dimensions x-6 [cm] 0.11 0.15
y-6 [cm] 0.12 0.10
PD [µs] 0.35 0.26
PRF [Hz] 500 500
EDS Azimuthal [cm] 0,50
Elavation [cm] 0.40
Operator Frequency mode PEN PEN PEN
Controls Focus point 3 3 3

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Acoustic output reporting table for Track 1


Autoscanning mode

System: InViewTM
Part nr: 411323
Sn: 05020017

Transducer Model: Probe Human L 10-5 20mm


Part nr: 311942
Sn: 50448010

Operating mode: B Mode

Application(s): C1.3

Acoustic Output MI ISPTA.3 ISPPA.3


[-] [mW/cm2] [W/cm2]
Maximum Value 0.96 44.4 255
Associated Pr.3 [MPa] 2.20
Acoustic W0 [mW] 6.0 5.2
Parameters fc [MHz] 5.3 5.2 6.6
Zsp [cm] 1.1 1.5
Beam dimensions x-6 [cm] 0.15
y-6 [cm] 0.10
PD [µs] 0.35 0.26
PRF [Hz] 4788 4788
EDS Azimuthal [cm] 1.43
Elevation [cm] 0.40
Operator Frequency mode Pen Pen Pen
Controls Focus point 3 4 4
Scan depth min min min

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Acoustic output reporting table for Track 1


Autoscanning mode

System: InViewTM
Part nr: 411323
Sn: 05020017

Transducer Model: Probe Human L 10-5 20mm


Part nr: 311942
Sn: 50448010

Operating mode: BMMode

Application(s): C1.3

Acoustic Output MI ISPTA.3 ISPPA.3


[-] [mW/cm2] [W/cm2]
Maximum Value 0.96 71.10 255.0
Associated Pr.3 [MPa] 2.20
Acoustic W0 [mW] 5.8 5.0
Parameters fc [MHz] 5.3 5.2 6.6
Zsp [cm] 1.1 1.5
Beam dimensions x-6 [cm] 0.15
y-6 [cm] 0.10
PD [µs] 0.35 0.26
PRF [Hz] 4700 4700
EDS Azimuthal [cm] 0.50
EBD Elevation [cm] 0.40
Operator Frequency mode Pen Pen Pen
Controls Focus point 3 4 4
Scan depth min min min

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Acoustic Output Reporting Table

Transducer model: 311492 (L10-5 20 mm)

Operating mode: BM-mode

TIS TIB
Index Label MI non-scan non- TIC
scan
Aaprt≤1 Aaprt>1 scan

Global Maximum Index Value 0,96 0,13 0,02 - 0,06 (a)


pra (MPa) 2,20
P (mW) 4,0 0,5 0,5 #
min of
(mW) -
[Pα(zS),Ita,α(zS)]
zS (cm) -
Assoc zbp (cm) -
Acoustic
zb (cm) 1,46
Parameter
z at max Ipi,α 1,06
deq(zb) (cm) 0,14
fawf (MHz) 5,3 6,6 6,6 - 6,6 #
X (cm) 0,50 0,50 - 0,50 #
Dim of Aaprt
Y (cm) 0,40 0,40 - 0,40 #
td (µsec) 0,35
prr (Hz) 4700
Other
pr at max Ipi (MPa) 2,62
Information
deq at max Ipi (cm) 0,15
2
Ipa,α at max MI (W/cm ) 210

Frequency PEN GEN GEN GEN


Focus 3 4 4 4
Operating
Control Depth (cm) 1,6 1,6 1,6 1,6
Conditions

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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Environmental operating conditions


‰ Not suitable for use in the presence of a
flammable anaesthetitc mixture with air or with
oxygen or nitrous oxide.

General storage Temperature –20 ÷ 60 °C (-4 ÷ 140 °F)

When used at the max specified ambient temp. of


40°C (104 °F), the transducer free air temp. can
reach a temp. of 46 °C (114,8 °F)

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