EDAN INSTRUMENTS AX8EDAN User Manual

Preface

This manual contains necessary and sufficient information to use the Acclarix AX8 system safely for the purposes for which it is intended. It applies to all 1.3X releases.

Read and understand all instructions in this manual prior to using the Acclarix AX8 ultrasound system.

Disregarding instructions, particularly warnings and cautions, is considered abnormal use. Caution: Federal law restricts this device to use by, or on the orders of, a physician.

Contact Information:

For sales or service information please contact your local distributor or the EDAN service department at: support@edan.com.cn

P/N: 01.54.002481 MPN: 01.54.002481014 Release Date: Dec., 2016 © Copyright EDAN INSTRUMENTS, INC. 2015-2016

Contents

1 Introduction ................................................................................................................................ 1

1.1 Intended Use/ Indications for Use .......................................................................................... 1

1.2 Contra-indications .................................................................................................................. 1

1.3 Device Description ................................................................................................................. 1

1.4 Labeling Symbols .................................................................................................................. 2

2 Safety ......................................................................................................................................... 5

2.1 Warnings ................................................................................................................................. 5

2.2 Cautions ................................................................................................................................. 7

3 Getting Started ......................................................................................................................... 10

3.1 System Configuration .......................................................................................................... 10

3.2 System Overview ................................................................................................................. 11

3.3 Battery Use ........................................................................................................................... 13

3.4 Connecting and Disconnecting a Transducer ....................................................................... 15

3.5 Powering on/ off ................................................................................................................... 17

3.6 Screen Layout....................................................................................................................... 18

3.7 Control Panel ........................................................................................................................ 21

3.8 Touch Screen ........................................................................................................................ 24

3.9 Trackpad ............................................................................................................................... 25

4 Exam Operation ....................................................................................................................... 27

4.1 How to Start an Exam .......................................................................................................... 27

4.2 How to End an Exam ........................................................................................................... 27

4.3 How to Restart an Exam ...................................................................................................... 27

4.4 The Patient Information Page ............................................................................................... 28

4.5 Modality Worklist ................................................................................................................ 30

5 Imaging .................................................................................................................................... 32

5.1 B-mode ................................................................................................................................. 32

5.1.1. B-mode Touch Screen Controls ................................................................................. 32

5.1.2. Dual Imaging ............................................................................................................. 35

5.1.3. Quad Imaging ............................................................................................................ 35

5.1.4. Panorama ................................................................................................................... 35

5.1.5. Zoom .......................................................................................................................... 36

5.2 PW-mode .............................................................................................................................. 37

5.2.1. PW Touch Screen Controls ........................................................................................ 37

5.2.2. HPRF ......................................................................................................................... 39

5.2.3. Update ........................................................................................................................ 39

5.3 CW-mode ............................................................................................................................. 39

5.3.1. CW Touch Screen Controls........................................................................................ 39

5.4 Color-mode .......................................................................................................................... 41

5.4.1. Color Touch Screen Controls ..................................................................................... 41

5.4.2. Color Mode Variants .................................................................................................. 43

5.5 M-mode ................................................................................................................................ 43

5.5.1. M-mode Touch Screen Controls ................................................................................ 43

5.6 3D/4D Mode* ...................................................................................................................... 44

5.6.1. Pre-3D ........................................................................................................................ 45

5.6.2. 3D Volume Sweeping ................................................................................................ 46

5.6.3. 3D Image Review ...................................................................................................... 46

5.6.4. 4D Volume Acquisition .............................................................................................. 51

5.6.5. 4D Live Volume ......................................................................................................... 52

5.6.6. 4D Cine ...................................................................................................................... 52

6 Transducers .............................................................................................................................. 53

6.1 Transducer Model ................................................................................................................ 53

6.2 Name and Function of Each Part of the Transducer ............................................................ 54

6.3 Transducer Cleaning and Disinfecting ................................................................................. 54

7 Features .................................................................................................................................... 58

7.1 Comments ............................................................................................................................ 58

7.2 Body Mark ........................................................................................................................... 59

7.3 Measurements ...................................................................................................................... 60

7.3.1. Generic Measurements .............................................................................................. 63

7.3.2. Application Measurements and Calculations ............................................................ 69

7.4 Patient Information Management ......................................................................................... 73

7.4.1. Storing Images ........................................................................................................... 73

7.4.2. Reviewing Images ...................................................................................................... 73

7.4.3. Patient Database ......................................................................................................... 75

7.4.4. Archiving Studies....................................................................................................... 77

7.5 Needle Biopsy Guide ........................................................................................................... 78

7.5.1. Installing Needle Guide Bracket ................................................................................ 78

7.5.2. Activating Needle Guide Function ............................................................................ 82

7.5.3. To Adjust the Needle Guide Line .............................................................................. 83

7.6 Needle Visualization ............................................................................................................ 83

8 Presets ...................................................................................................................................... 85

8.1 Preset Organization .............................................................................................................. 85

8.2 Selecting a Preset ................................................................................................................. 86

8.3 Storing a Preset .................................................................................................................... 86

8.3.1. Presets ........................................................................................................................ 87

8.3.2. Comments Presets ...................................................................................................... 90

8.3.3. Bodymarker Presets ................................................................................................... 91

8.3.4. Measure Presets ......................................................................................................... 93

9 Utilities .................................................................................................................................... 97

9.1 Set-up ................................................................................................................................... 97

9.1.1. General Set-up ........................................................................................................... 97

9.1.2. Patient Set-up ............................................................................................................. 99

9.1.3. Store/Print Set-up ..................................................................................................... 100

9.1.4. Miscellaneous Set-up ............................................................................................... 101

9.1.5. User Set-up .............................................................................................................. 102

9.2 Connectivity ....................................................................................................................... 103

9.2.1. TCP/IP ..................................................................................................................... 103

9.2.2. DICOM .................................................................................................................... 104

9.2.3. Network Store .......................................................................................................... 107

9.3 Maintenance ....................................................................................................................... 108

9.3.1. License ..................................................................................................................... 108

9.3.2. Version ..................................................................................................................... 108

III

9.3.3. Demo ........................................................................................................................ 109

9.3.4. Export/Import ........................................................................................................... 109

9.4 Screen Adjust ..................................................................................................................... 111

10 In Between Exams ................................................................................................................. 113

10.1 Unpacking ........................................................................................................................ 113

10.2 Transport .......................................................................................................................... 113

10.3 Storage .............................................................................................................................. 113

11 Order List ............................................................................................................................... 114

12 Troubleshooting and Maintenance ......................................................................................... 116

12.1 Daily Checklist ................................................................................................................. 116

12.2 Troubleshooting ............................................................................................................... 116

12.3 Maintenance ..................................................................................................................... 117

12.4 Cleaning the System ......................................................................................................... 117

12.4.1. Cleaning the System Surface ................................................................................... 118

12.4.2. Needle Guide Bracket Cleaning and Sterilization ................................................... 118

13 Specifications ......................................................................................................................... 119

13.1 Electrical Safety Classifications ....................................................................................... 119

13.2 Power Supply ................................................................................................................... 119

13.3 Machine Specifications .................................................................................................... 120

13.4 Display Specifications ...................................................................................................... 120

13.5 General Technical Specifications ..................................................................................... 120

13.6 Operating, Storage and Transportation Environment ....................................................... 121

13.6.1. Operating Environment ............................................................................................ 121

13.6.2. Storage and Transportation Environment ................................................................. 121

14 EMC Information ................................................................................................................... 122

Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction

1 Introduction

1.1 Intended Use/ Indications for Use

For the United States of America The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied

health professional for ultrasound evaluations. Specific clinical applications include:

 Abdominal  Gynecology (including endovaginal)  Obstetric  Cardiac  Small parts (Breast, Testes, Thyroid, etc.)  Urology  Musculoskeletal  Peripheral vascular  Intra-operative

For the EU and other non-USA regions The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied

health professional for ultrasound evaluations. Specific clinical applications include:

 Adult Cephalic*

1.2 Contra-indications

The Edan Acclarix AX8 Ultrasound system is not intended for ophthalmic use.

1.3 Device Description

The Edan Acclarix AX8 Ultrasound system consists of a main system along with associated transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which

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Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction

No.

Symbol

Definition

1 Serial Number

P/N

Part Number

3 Date of Manufacture

4 Manufacturer

5 Operating instructions

Warning (Background: Yellow; Symbol & outline: Black )

Refer to User Manual (Background: Blue; Symbol: White)

Caution

9 Biological Risks

The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices.

then converts back to an electrical signal. The Acclarix AX8 system then analyzes the returned signal to generate an image or conduct Doppler processing. The Acclarix AX8 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. The system provides both touch screen and hard buttons for the User Interface. *Descriptions of transducer C5-2MQ, adult cephalic application, 3D/4D function, PW one-key

optimization, acoustic power control, panorama measurement and wireless function are not

approved for use until finishing the related registration.

1.4 Labeling Symbols

The following labels are used on the Acclarix AX8 system:

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Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction

Authorized Representative in the European Community

Disposal method. Indicates that the equipment should be sent to special agencies according to local regulations for separate collection after its useful life.

General Symbol for Recovery / Recyclable

Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.

Conforms to AAMI Std. ES 60601-1, IEC Std. 60601-2-37

Certified to CSA Std. No. 60601-1, No 60601-2-37

IPX7

No harm for short time immersion

Type BF Applied Part

Transducer connector

Pencil Transducer connector (reserved)

ECG signal input connector (reserved)

Transducer lock

Transducer unlock

Network port

Trademark

Direct current

Video Output port

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Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction

USB 2.0 port

USB 3.0 port

Display port

Microphone input

Headphones

FCC ID:

SMQAX8EDAN

Federal Communication Commission: FCC ID: SMQAX8EDAN

NOTE:

The user manual is printed in black and white.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

2 Safety

Throughout this document the following terms are used:

 Warning: Advises against certain actions or situations that could result in personal injury

or death.

 Caution: Advises against actions or situations that could damage equipment, produce

inaccurate data, or invalidate a procedure.

 Note: Provides useful information regarding a function or a procedure.

Please read all warnings and cautions prior to using the Acclarix AX8 ultrasound system. For your convenience all warnings and cautions are provided in this section. These may be duplicated elsewhere in this document in the context of the instructions for use.

2.1 Warnings

 Only use an Edan supplied power adapter and power cord.  Only use an Edan supplied battery. Read and understand the battery installation

instructions prior to changing the battery.

 Only use Edan supplied transducer. Use of other transducers may result in electric

shock or system malfunction.

 Only use a hospital grade, grounded, power outlet and plug. Do not use with an

ungrounded outlet.

 The system is ordinary equipment (Sealed equipment without liquid proof). But the

console panel including touch screen, track pad and hard keys is IPX1. Transducer (not including the transducer connector) is IPX7. Footswitch is IP68. Do not immerse or expose any of the parts to extended moisture. Splash resistance does not extend to transducer connectors. Keep connectors dry.

 Do not use in a wet environment or when the relative humidity exceeds 95%.  Do not reverse the positive and negative poles when installing a battery.  Do not use the battery near heat sources or when the ambient temperature is over

40oC. Do not heat or dispose of in fire.

 Do not destroy the battery; do not pierce or cause a strong impact to the battery.  Do not touch the connector pins on the transducer port.  Parts and accessories used must meet the requirements of the applicable

IEC/EN60601 series safety standards, and/or the system configuration must meet the requirements of the IEC/EN60601-1.

 Use protective barriers (gloves and transducer sheaths) whenever possible.

Follow sterile procedures when appropriate. Thoroughly clean Transducers and reusable accessories after each patient examination and disinfect or sterilize as needed. Refer to transducer use and care instructions. Follow all infection control policies established by your office, department or institution as they apply to personnel and equipment.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

 Not intended for Ophthalmic use.  If a sterile transducer cover becomes compromised during an intra-operative

application involving a patient with transmissible spongiform encephalopathy, such as Creutzfeldt-Jakob disease, follow the guidelines of the U.S. Disease Control Center and this document from the World Health Organization: WHO/CDS/APH/2000/3, WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies. The transducers for your system cannot be decontaminated using a heat process.

 Contact with natural rubber latex may lead to a severe anaphylactic reaction in

persons sensitive to the natural latex protein, Sensitive users and patients must avoid contact with these items. EDAN strongly recommends that health-care professionals identify their latex-sensitive patients, and refer to the March 29, 1991 Medical Alert on Latex products. Be prepared to treat allergic reactions immediately.

 Improper operation may cause the internal lithium battery (hereinafter called

battery) to be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It is necessary to read the user manual carefully and pay more attention to warning messages.

 Do not touch accessible contacts of electrical equipment and the patient

simultaneously.

 This device is not suitable for intra-cardiac use or direct cardiac contact.  The system shall not be serviced or maintained while in use with a patient.  Install the system according the EMC guidance provided in Chapter 14  Do not stack the system on other electronic equipment.  The use of transducer and connecting cable not supplied by the manufacturer may

result in increased emissions or decreased immunity of the equipment.

 Refer to Chapter 14 for recommended separation distances from other equipment,

including portable and RF communication devices.

 The power adapter is used to isolate the system from main power. Position the

system so that it is easy to disconnect the device.

 No modification of this equipment is allowed.  The system should be maintained regularly, at least annually, by a qualified

technician who has adequate training, knowledge and experience. That person should be familiar with the AX8 Service Manual (P/N: 01.54.002483), available from your Edan representative.

 Keep non-medical equipment (such as the external printer) out of the vicinity of the

patient. (1.5m/6ft.)

 Use of an extension cord or multi-socket outlet setup to provide power to the

ultrasound system or to the system‟s peripheral devices, may compromise the

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

system grounding and cause the system to exceed leakage current limits.

 SHOCK HAZARD – Do not connect non-isolated electrical equipment to the same

circuit being used to power the system.

 Edan recommends the use of isolated connectors on any electrical equipment

attached to the system, and/or using isolation transformers that complies with IEC60601-1 to power that electrical equipment.

 Always use sterile technique during a biopsy procedure. Sterilize the needle

guide assembly between uses.

 Use a sterile needle with each use.  Always confirm the clinical accuracy of the IMT result before entering it into the

report.

Transducer Warnings

 To avoid infection, always use protective gloves when cleaning or disinfecting  Read and follow all manufacturer instructions for disinfection agents.  To avoid infection, ensure that expiration date of the disinfecting solution has not

passed.

 Disinfect the transducer after each intra-cavity or intra-operative procedure. Use a

new sterile sheath for each such procedure.

 Use a pyrogen-free transducer sheath for neurological intra-operative procedures.  Unplug the transducer from the system prior to cleaning or disinfecting.  Do not immerse the transducer beyond the point indicated in Figure 6-2.  Do not allow the transducer connector to get wet.

2.2 Cautions

 The system contains no user serviceable components other than the battery. Do

not remove any covers.

 Excessive dust and dirt could clog internal airflow and cause overheating. Do not

use in a dusty environment.

 Do not use a battery that leaks, emits an odor, appears deformed, or discolored.

Immediately replace it with a new Edan-supplied battery and dispose of the old battery according to local regulations. Replace a battery that has reached the end of its service life.

 Use care when storing or disposing of batteries. Do not allow the leakage to come

in contact with each other. Do not dispose of them together with household garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries.

 Inspect the system regularly, at least weekly. Before use ensure there is no visible

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

evidence of damage to the equipment, cables, and transducers. If a component is damaged replace it before use.

 Do not use in locations subject to vibration.  Read and understand the section A1.2 Ultrasound Safety and the ALARA Principle

of Acclarix AX8 Advanced User Manual before using the system. Do not expose a patient to ultrasound energy longer than clinically reasonable.

 Practice ALARA principle when operating ultrasound system. Minimize the

acoustic power without compromising the image quality.

 Do not use in the presence of a flammable anesthetic.  The system generates radio frequency energy, which may cause interference with

other devices in the vicinity. If interference is suspected, try re-orienting or relocating the equipment.

 The use of electrosurgical units or other devices that generate radio frequency

interference may cause image distortion or other malfunction.

 During long term storage the battery should be charged at least once every 3

months to ensure battery capacity.

 The system should only be used by a qualified physician or allied health

professional for ultrasound evaluations.

 Use only Edan supplied or recommended parts and accessories.  Verify measurement results prior to entering them into a report.  Contact your local distributor or Edan service if there is excessive noise from the

system speaker or fans.

 Please read and understand cleaning instructions prior to use.  Please read and understand maintenance instructions prior to use.  Please read and understand instructions for system operation prior to use.  Studies stored on the system hard drive should be archived regularly. The system

is not intended for long term storage of patient information. Confirm successful archiving before deleting a study from the hard drive.

 Ensure that the system vents are clear and unobstructed.  Confirm patient identification information prior to storing or printing any exam

information.

 If you have any questions about maintenance, technical specifications, or system

functionality, please contact your local distributor or Edan service at: support@edan.com.cn

 Ultrasound images occasionally have artifacts, and should only be used as one

part of an overall clinical assessment.

 To avoid electrical shock, turn off and disconnect the device from the AC power

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

source before cleaning and disinfecting.

 The device and accessories are to be disposed of according to local regulations

after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal.

Transducer Cautions

 Do not use disinfection agents beyond their expiration date.  Do not use sterile sheaths beyond their expiration date.  Inspect the transducer connector, cable, and head periodically. Do not use if there

is evidence of excessive wear or damage.

 Do not operate the transducer to temperatures in excess of 40°C or storage the

transducer to temperatures in excess of 55°C .

 Do not kink or pull on the transducer cable.  Broken or bent connector pins can cause image artifacts. Do not use a transducer

with broken or bent pins.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

Printer Model

Printer Type

Interface

SONY UP-25MD

Color Image

S-Video

SONY UP-D25MD

Color Image

USB

SONY UP-X898MD

B/W Image

USB

HP Officejet Pro 251dw

Color Report

USB

HP Laserjet Pro 200 M251n

Color Report

USB

HP Laserjet CP1525n Color

Color Report

USB

HP Deskjet Ink Advantage 2010

Color Report

USB

HP Deskjet 1010 Color

Color Report

USB

HP Deskjet 1510 Color

Color Report

USB

HP LaserJet 400 M401d

B/W Report

USB

3 Getting Started

3.1 System Configuration

The Acclarix AX8 system is shipped with the following components:

 Acclarix AX8 main unit  1 rechargeable lithium battery  1 UPS battery  1 AC adapter  1 bottle of coupling gel  1 basic user manual and 1 advanced user manual

The following options are also available (please see the Order List Appendix for details)

 Transducers: C5-2XQ, C5-2Q, L10-4Q, L12-5Q, L17-7HQ, E8-4Q, MC8-4Q, P5-1XQ,

L17-7SQ, C5-2MQ*

 1 Trolley MT-807  Footswitch  Suitcase  The Acclarix AX8 supports the following external DVD drives: SAMSUNG SE-218GN,

SAMSUNG SE-208GN, LENOVO DB75, ASUS SDRW-08D2S-U and PIONEER DVR-XU01C.

The Acclarix AX8 supports the following DVD disks: Philips CD-R 700MB 80min 52x, Sony CD-RW 700MB 1x-4x,Sony DVD-RW 4.7GB 120min 2x/1x, Verbatim DVD+RW 4.7GB 120min 4x.

Note: Only support DVD disk single burning.

 The Acclarix AX8 supports the following printers. Please contact the manufacturer for

details.

Table 3-1 Printer List

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

Model

Name

Description

BGK-C5-2

BGK-C5-2 Needle Guide Bracket Kit

For use with the C5-2XQ/C5-2Q, Supports: 16G, 18G, 20G, 22G

BGK-L40UB

L40UB Needle Guide Bracket Kit

For use with the L10-4Q, Supports: 16G, 18G, 20G, 22G

BGK-CR10UA

CR10UA Needle Guide Bracket Kit

For use with the E8-4Q, Supports: 16G

BGK-R15UB

R15UB Needle Guide Bracket Kit

For use with the MC8-4Q, Supports: 16G, 18G, 20G, 22G

BGK-P5-1X

BGK-P5-1X Needle Guide Bracket Kit

For use with the P5-1XQ Supports: 14G-22G

6 7

8 9

Note: For more printer models, please see: http://hplipopensource.com/hplip-web/supported_devices/combined.html . Generally, printer models with driver version 3.14.3 or lower can be supported by Acclarix AX8, but some models cannot be perfectly supported.

 Needle Guide Bracket Kit

Table 3-2 Needle Guide Bracket Kits

3.2 System Overview

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

No.

Name

Description

Monitor

Display the images and parameters during scanning.

Touch Screen

Use to control operation and activate functions

Control panel

Use to control the operation

Handle

Used for carrying the system

Hinge

Used to rotate the monitor

Transducer locking lever

Use to lock or unlock the transducer

Transducer Port

Used for connecting a transducer to the Acclarix AX8 main unit

TrackPad

Use to change the cursor position

Battery Indicator

LEDs indicate battery charge. Each LED corresponds to 20% of battery power. The LEDs will flicker while the battery is charging. Touch the battery indicator to view the battery power.

I/O Ports

Use to connect the I/O extend modules

Figure 3-1 Appearance of the System

Table 3-3 Appearance of the System

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

1. Power supply

5. USB 2.0 port

2. S-Video output port

6. Network port

3. Display port

7. Microphone input port

4. USB 3.0 port

8. Audio output port

1 3 4

5 6 7 2 8

I/O Ports on the left panel:

Figure 3-2 I/O ports of the system

Table 3-4 I/O Ports of the System

NOTE：If an external monitor is connected to the system via display port, configure the resolution to 1920x1080, other resolution may cause abnormal ultrasound machine display.

3.3 Battery Use

The Acclarix AX8 system comes with one lithium-ion battery. When it is fully charged it can run the system for approximately 60 minutes, depending on use. It is automatically charged when the system is plugged in.

CAUTION

1. If the system will remain unused for more than one week, charge the battery to at

least 75%capacity, take the battery out and store the system and battery separately.

2. During long term storage the battery should be charged at least once every 3 months

to ensure battery capacity is more than 75%.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

To install the battery:

1. Turn off and unplug the Acclarix AX8 system.

2. Close the monitor, turn the system upside down and rest it on a flat stable surface.

3. Put the battery gently to battery compartment, and the button will lock the battery

automatically.

Figure 3-3 Installation of the Battery

To remove a battery:

1. Turn off and unplug the Acclarix AX8 system.

2. Close the monitor, turn the system upside down and rest it on a flat stable surface.

3. Slide the battery button to unlock the battery.

4. Take the battery out.

Figure 3-4 Battery Removal

To install the UPS battery:

1. Close the monitor, turn the system upside down and rest it on a flat surface.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

2. Take out the UPS battery from the package.

3. Put the UPS battery gently to the UPS battery compartment.

Figure 3-5 Installation of the UPS Battery

3.4 Connecting and Disconnecting a Transducer

To connect a transducer:

Figure 3-6 Tansducer Locking Handle

1. Align the connector with the transducer port and carefully push into place.

2. Toggle the locking handle to the bottom position.

3. Do not allow the transducer head to hang free. Impact to the transducer head could result in

irreparable damage.

Figure 3-7 Lock the tansducer locking handle

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

To disconnect a transducer:

1. Toggle the locking handle to the top position to unlock the connection of the Transducer.

2. Firmly grasp the transducer connector and carefully remove it from the system port.

3. Store transducer in its protective carrying case prior to transport.

Figure 3-8 Unlock the Tansducer Locking Handle

CAUTION

1. Do not touch the pins of the transducer connector.

2. Broken or bent connector pins can cause image artifacts. Do not use a transducer

with broken or bent pins.

Multi-Transducer Connector (MTC)

The Multi-Transducer Connector (MTC) is an optional addition to the AX8 that allows up to three transducers to be connected to the system. The MTC can be mounted to the optional AX8 cart, or lie flat on an adjacent table.

Figure 3-9 Connect to the MTC

Note: Pluging and unpluging the MTC should be done while the system is frozen or turned

off.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

3.5 Powering on/ off

Please review and follow the steps described in the Section 12.1.Daily Checklist prior to powering on the device.

 To power on:

1. Connect the system to a hospital grade power supply, or use the battery as the power supply.

2. Press the power on/off key on the top left of control panel.  To Login

If Password Protection is enabled (see section 9.1.5), the system displays a Login dialog when booting up the system, you can type in or select user name in the drop-down list of User name, then enter password and click Login.

For emergency use, you can click on Emergency to log on directly without entering user name and password.

Note:

When both Admin1 and Admin2 password are forgotten, please contact the serviceman for the system password reset.

 To power off:

1. Press the power on/off key on the top left of control panel and the system displays a

confirmation dialog box.

2. Select “Shut Down” from the confirmation dialog box. If the system is unresponsive, a long press of the power on/off key will shut down the system

directly.

NOTE:

Please unplug the AC adapter from the power socket and disconnect the battery prior to storage.

 Sleep mode The system will enter a sleep mode that maintains exam information while using minimal battery.

There are three events that can invoke sleep mode:

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

①

③

④

⑤

 Close the cover of the system without powering-off the system.  No user input for a configurable amount of time. Please see System Set-up to configure

this time.

 Pressing the Sleep button on the confirmation dialog box when powering off.

Figure 3-10 Confirmation Dialog Box When Power off

3.6 Screen Layout

Figure 3-11 Main Screen Display

①Information Field：

The top line of this field contains your hospital/institution name. Please see Section 9.1. General Set-up for information on customizing this area.

The second line of this field contains the patient name, gender, age and ID, as entered through the Patient Information screen.

This field also contains data fields for:

 The currently active transducer

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

 The currently active preset  MI, TI, current date and time.

②Image Field:

The ultrasound image appears in the Image Field, under the Information field. The image field also contains information typically associated with the image, such as scales, TGC, and maps. The system supports two different image sizes within the image field. See 9.1.1 for details

③Mini Report:

The left side of the screen displays a “mini-report” which provides a synopsis of applications measurements performed in the current exam.

④Thumbnail Field:

The right side of the screen displays thumbnail images of all statics and clips captured in the current exam.

⑤Status Bar:

The bottom of the screen is used to display icons that provide system status. These include:

 Image Store icon

: Number of static images and clips in the current exam.

 Battery icon

: Battery fully charged, symbol in green.

: Battery higher than 80%.

: Battery 60%-80%.

: Battery 40%-60%.

: Battery low, symbol in red.

: Battery removed, outline in red.

: Battery charging.

 Network status icon

The network icons show the connection status of the DICOM or FTP Server. If no

Network Server is defined then the icon does not show at all.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

: Outline in grey color: Successful connection with a Server. Outline in green color: Data exchange with a Server. Outline in red color: Failure to connect with a configured Server.  Hard drive icon.

: Hard drive available

: Hard drive data exchange, symbol in green.

: Hard drive 95% full, symbol in red.

: Hard drive 95% full with data exchange, symbol in red.

 USB icon

Symbol in grey color: USB available

 DVD icon

: Symbol in grey: DVD device is connected

: Symbol in green: DVD device is connected, disc is inserted and data

transmission is available.  Printer icon

: Printer available.

 Wifi icon *

：Wi-Fi available, Subject to regulatory approval. See Connectivity (Section

9.2.1) for enabling wireless if it is licensed. Clicking on this icon shows a list of all Wi-Fi networks that are currently available.

WARNING

The system complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

1) this device may not cause harmful interference, and

2) this device must accept any interference received, including interference that may

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

No.

Key

Name

Description

Patient

Invokes the Patient Information Screen. Typically used to start/end exams or to modify patient information during an exam. See section 4.1

cause undesired operation.

NOTE:

1. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential 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 radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

- Connect the equipment into an outlet on a circuit different from that to which the

receiver is connected.

- Consult the dealer or an experienced radio/TV technician for help.

2. Any changes or modifications to this unit not expressly approved by the party

responsible for compliance could void the user's authority to operate the equipment.

3.7 Control Panel

Figure 3-12 Control Panel of the System

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

Preset

Allows you to change the Preset being used. See section 8 for details.

End Exam

Completes an exam without invoking the Patient Information Screen for the next exam. See section 4.2

Utilities

Press this button to get the Set Up, Maintenance, Connectivity and Screen Adjust keys on the touch screen.

Alt Store

One of three keys that can be configured to store images or clips, or to set video printers. See section 7.4 for details.

Report

Press to display the report page

Review

Press to enter exam database or image review mode. See section 7.4 for details.

Zoom

Press to zoom the image in or out. See section 5.1.5 for details.

Depth

Press to adjust the depth of the image displayed.

10.

Body Mark

Enters or exits the Body Mark function. See section 7.2 for details.

11.

Clear

Press to clear all the measurements, calculations, comments, and body marks displayed in the current image.

12.

Comment

Enters or exits the Comment function. See section 7.1 for details.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

13.

Update

In Strip Doppler this switches between acquiring the Doppler strip and the reference image. See section 5.2.3 for details.

14.

Cursor

Press to hide or display the cursor

15.

Measure

Invokes the Measure function for Generic and Application Measurements. See section 7.3 for details.

16.

Freeze/Cine

Press this key to switch between the frozen and real-time states.

17.

Store 1

One of three keys that can be configured to store or print images or clips, or to set video printers. See section 7.4 for details.

18.

Store 2

One of three keys that can be configured to store or print images or clips, or to set video printers. See section 7.4 for details.

19.

Gain

Controls the overall gain for the imaging mode that currently has the UI focus. In normal imaging the gain can also be adjusted by sliding your finger along the top of the trackpad area

20.

User-defined button

21.

User-defined button

22.

Color

Press to enter or exit Color Mode. See section 5.4 for details

23.

Press to enter or exit M Mode. See section 5.5 for details. Use the trackpad to adjust the M sample line.

24.

Press to get the sample line, use the trackpad to adjust the position and press the hardkey again to confirm.

For other information, see section 5.2 and 5.3 for details.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

25.

Press to return to B-mode imaging from any display or imaging mode. See section 5.1 for details.

Table 3-4 Buttons on Control Panel

3.8 Touch Screen

The Touch Screen contains controls that vary depending on the active function. There are several types of controls used by the touch screen, as illustrated below:

Figure 3-13 Touch screen of the System

A. Tabs: Each function that is active has a tab on the touch screen. Usually the function that

was most recently activated is the top tab. Pressing on any other tab will bring it to the top and provide access to that function‟s controls.

B. Slider: Pressing on the top or bottom of a slider changes the control setting by one value.

Pressing anywhere on the control and dragging will continuously change the value.

C. Push button: This can either be an on/off control (like “Colorize”) or a one-shot control

that immediately performs an action (like “Auto”)

D. Radio Buttons: A collection of buttons where only one is active at any time. Activating

one will de-activate all others.

E. Folder: Controls can be grouped together into a folder. Pressing on the folder will open it

to access any of the controls in it.

F. TGC: The B-mode tab has a specialized control for TGC. Each slider can be dragged

horizontally and individually. Dragging vertically down across the sliders will set all sliders.

G. Pages: When a tab has multiple pages of controls each page is represented by a dot at the

top of the page. The current page is indicated by a filled-in dot. You can move between pages by dragging your finger horizontally across the dots. These dots do not appear when there is only one page in the current tab.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

Customizing the touch screen

The touch screen can be customized to meet your needs. Press and hold any control for about a second to put the touch screen in customization mode. Continue pressing and drag the control to a new location.

 Creating Folders: Dragging one control on top of another control will create a folder that

contains both controls. Dragging controls out of a folder until only one exists will automatically delete that folder. Folders cannot contain other folders.

 Multiple pages: Dragging a control to the side of the screen will move that control to the

next page.

 Radio Button Cluster: There is no restriction on moving a single radio button. However,

we suggest that they are grouped adjacent to each other. When they are grouped in this way the system will automatically draw a border around them to indicate they are a related group of radio buttons.

 TGC: The TGC is a special control that cannot be moved. It is always on the right side of

the B-mode tab.

For most tabs there is one arrangement of controls. Whatever way they are customized will be remembered across exams and across power-ups. However, the following tabs can have multiple different arrangements:

 Comments  Bodymarkers  Measurements

These functions are often configured differently for different exams. For example, the measurements for an OB exam are different from those of an abdomen exam. Each configuration of these tabs is stored in an application preset (see Chapter 8 Presets, for details)

3.9 Trackpad

In general the Acclarix AX8 trackpad is used like a trackball or similar pointing device used on most ultrasound systems. Using a trackpad instead of a trackball helps make the console sealed, and makes the system easier to clean. In addition, there are several capabilities that the trackpad supports that would not be possible on a traditional trackball:

 The trackpad supports multi-finger gestures. For example:

o While in B-mode a pinch-out gesture can be used to zoom the image. o While in Color a pinch gesture can re-size the ROI.

 Dragging along the Swipe button on top edge of the trackpad as a primary sliding control.

For example:

o In most live imaging modes this is Gain.

 The top right of the trackpad is reserved as a „Set‟ button. Pressing this corner is generally

equivalent to a single click on a mouse or trackball. For example:

o In CD it is used to toggle between controlling the size and the position of the pan

box.

o In Measure it is used to toggle between controlling one side or the other side of a

caliper pair.

 The top left of the trackpad is reserved as an „Enter‟ button. Pressing this corner is

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

generally equivalent to a double click on a mouse. For example:

o In Measure it is used to enter a measurement into a report.

The examples provided above are a subset of how the trackpad is used. Additional examples are provided in specific feature descriptions elsewhere in this manual.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Exam Operation

4 Exam Operation

4.1 How to Start an Exam

To start a new exam, press the Patient key and enter in patient information for the exam, or select a scheduled patient from the modality worklist.

If there is no previous exam this will bring you directly to the Patient Information Page (see figure 4-2 below). If a previous exam is still active you will see the following dialog:

Figure 4-1 Exam Confirmation Dialog

It has the following options:

 Edit Current: This lets you edit the Patient Information for the current exam. It does not

start a new exam.

 New Exam: Select this to start a new exam with the same patient. It confirms that you

want to end the previous exam, and then displays the Patient Information Page with the previous patient information still displayed.

 Cancel: Exits the dialog without starting or ending an exam.  New Patient: Select this to start a new exam. It confirms that you want to end the

previous exam, and then displays a blank Patient Information Page for the new exam.

4.2 How to End an Exam

There are two ways to end an exam:

 Pressing the Patient key, as described above, and then selecting the New Patient. This

both ends the exam and presents the Patient Information Page for the next exam. This is the most common way of ending the exam, especially when there are several exams in a row.

 Pressing the End Exam key. This brings up a dialog to confirm you want to end the exam,

but does not invoke the Patient Information Page for the next exam. You might end the exam this way when there is no exam next.

When an exam is ended the associated files on the system are closed. If a DICOM server is connected successfully and Auto-transfer when End Exam is configured, any remaining images are transferred.

4.3 How to Restart an Exam

1. Select an exam within the time limit in Exam Database. For the setting of time limit, refer to

section 9.1.2 Patient Set-up.

2. Press Restart on the touch screen to continue/edit the exam that was performed on the

selected patient. You can also modify the patient information by pressing Patient-->Edit Current.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Exam Operation

4.4 The Patient Information Page

The Patient Information Page is used to enter or modify patient demographic data. The following figure is an example:

Figure 4-2 Patient Information Page(OB Exam)

The top three lines are for entering the patient last name, first name, ID, exam accession number, and DOB (Date-of-Birth) or age. If a date of birth is entered the age is automatically calculated.

Note: By default the patient name is two fields: family name and given name. It can be

configured to be one field in the Patient Setup screen (See section 9.1.2 for detail).

The next line shows the current transducer, and the preset that will be used for the current exam. See section 8.3.1.2 for information on presets. The preset can be changed by clicking this drop-down and selecting one of the other presets associated with the current transducer.

The lines below the preset-selection vary depending on the current preset (see section 8.3.1.2 for detail). They show clinical information that is preset-specific.

 Gender: Select the patient‟s gender: “M” (Male), “F” (Female), “O” (Other), or “<blank>”.

“F” is default for gynecology, obstetric and breast exams; “M” is default for prostate

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Acclarix AX8 Diagnostic Ultrasound System User Manual Exam Operation

exam and testis exam; <blank> is default for others exam.

 LMP: Last Menstrual Period (yyyy/mm/dd), If LMP is entered then GA and EDD are

calculated. Entering EDD does not impact LMP. An LMP more than 300 days ago is considered invalid.

 GA: Gestational Age (xxWyD), it is auto-calculated when LMP or EDD is entered (only

in OB Exam). A GA of more than 42W6D is considered invalid and not displayed.

 EDD: Estimated Date of Delivery (yyyy/mm/dd). It is auto-calculated when LMP is

entered..

 Fetus: Enter 1 up to 4, for multiple gestations.  G/P/A: G stands for Gravida, P stands for Para and A stands for Aborta. Enter the times of

them in the fields separated by slashes.

 Study Description: enter the study description.  Height: Enter the patient‟s height. The units can be set in the Patient section of Setup.  Weight: Enter the patient‟s weight. The units can be set in the Patient section of Setup.  BSA: Body Surface Area, it is auto-calculated and displayed when Height/Weight is

entered.

 HR: Enter the Heart Rate.  BP: Enter the Blood Pressure.  PSA: Prostate Specific Antigen.  PPSA Coefficient: Predicted Prostate Specific Antigen.  Ref. Physician: Enter the name of the Ref.Physician.  Dx. Physician: Enter the name of the Dx.Physician.  Operator: Enter the name of the person performing the exam. .  CPT code: Current Procedural Terminology code.  <Custom field 1>: Enter the user-defined data.  <Custom field 2>: Enter the user-defined data.  Comments: Enter any additional comments.

While the Patient Information Page is displayed the following touch screen controls are shown:

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Acclarix AX8 Diagnostic Ultrasound System User Manual Exam Operation

Figure 4-3 Patient Information Touch Screen

Press Start Exam to exit the Patient Page function and return to B-mode imaging with the newly entered demographic data entered for the active exam.

Press Cancel to exit the Patient Information Page without storing any of the entered data. Press Clear All to clear all of the demographic fields except for name and ID. Input LMP, and press Prior Exam to enable the entry of previous OB exam data for fetal

trending details, it is only available when an OB preset is selected.

4.5 Modality Worklist

Modality worklist provides a list of scheduled patients derived from a DICOM server. It is available only when a DICOM server is configured and worklist is enabled.

When the modality worklist function is enabled and configured in DICOM Connectivity screen, the worklist is shown to the left of the Patient Information Page, as shown below.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Exam Operation

Figure 4-4 Modality Worklist Display

The worklist is displayed at the left side of the Patient Information Page in two columns showing patient name and patient ID. Clicking on the header of each column will sort the list by the corresponding column.

The worklist shows all scheduled ultrasound exams within the date-range specified in the Connectivity Utility (See 9.2.2). Typing any text in the Patient Name or ID fields will filter the list to exams that contain the entered text.

Update: Press it to query the patient data and update the list manually. Hide List: Press it to hide the list with only a Show List button displayed. Press the Show List

button to display the list and other buttons. Select one patient from the list and the detailed patient information is filled in the associated

fields on the patient information page, allowing you edit or complete. Then press Start Exam on the touch screen to start an exam.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Key

Description

The B-mode key behaves differently than the other mode keys. B-mode imaging is the baseline state of the system. Therefore, the B key returns to B-mode imaging at any time from any display on the system. See section 5.1 for B-mode controls.

Invokes and exits strip Doppler mode. Press D button and press PW/CW on the touch screen to switch to CW mode (requires P5-1XQ transducer). See section

5.2/5.3 for Doppler controls.

Invokes and exits color modes, including Color, Power Doppler Imaging (PDI) and Directional Power Doppler Imaging (DPDI). The default color mode is determined by the preset and can be changed while Color is active. See section 5.4 for Color controls.

Invokes and exits M-mode. See section 5.5 for M-mode controls

Name

Control

Description

TGC

The Time Gain Control (TGC) adjusts the gain of the image at different depths. Each slider can be adjusted separately, or you can drag your finger vertically to set all of the sliders to a new setting.

Auto

The Auto push button controls automatically updates the Gain and TGC. Each single press of the button renews the automatic optimization.

Dynamic Range

The Dynamic Range, or log compression, adjusts how echo intensities are converted to brightness. A high dynamic range presents a flat image, while a low dynamic range present a large range of intensities.

5 Imaging

The imaging modes are entered and exited via dedicated hard keys along the right side of the console.

Table 5-1 Mode Control Hard Buttons

5.1 B-mode

5.1.1. B-mode Touch Screen Controls

The following touch screen controls impact the B-mode image. Touch screen controls can be located where you want them to be. See section 3.8 for details.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

eSRI

eSRI is Speckle Reduction Imaging. There are 4 levels: Off, Low, Med. and High. High level provides more aggressive speckle reduction.

Persistence

Persistence averages frames together in order to reduce random noise. There are 4 options: Low, Med., High and Off. The persistence level corresponds to the number of frames averaged. The frame rate is unchanged; as each new frame is acquired it is averaged with the preceding frames.

Frequency

This determines the fundamental or harmonic (with harmonic invokes) frequencies used for imaging. It is available on live images.

Harmonic

The Harmonic control invokes and exits harmonic imaging. While in harmonic imaging the control is highlighted and „H‟ in the B-mode frequency field. Depending on the transducer there may be multiple harmonic frequencies.

Spatial Compounding

Spatial Compounding combines images fired from multiple angles in order to reduce speckle, reduce shadow artifacts, and enhance contrast. Spatial compounding is an on/off control.

Foc. Num

Focus Number adjusts the number of focus positions. As the number of foci increases the frame rate will decrease, but there will be more image uniformity across depths.

Foc. Pos.

Focus Position adjusts the depth of the focus or foci. Upward presses move the focus shallower, regardless of the U/D invert status of the image.

Gray Map

Gray Map adjusts the post processing map used on the B-mode image. In general, higher map numbers correspond to more contrast in the image.

Colorize

The Colorize control adds a color tint to the B-mode image.

Tint

The Tint control changes the color tint being used. Gold, Sepia, Blue, Ice and Clear are available. If Colorize had been off, changing the Color map control will automatically activate it.

Left/Right

The Left/Right invert control is indicated by a backward R. It toggles the left/right orientation of the image. The Edan E orientation marker at the top of the image switches with the left/right invert to match the orientation marker on the transducer.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Up/Down

The Up/Down invert control is indicated by an upside-down R. It toggles the up/down orientation of the image. The TGC also swaps so the top of the TGC corresponds to the top of the image on the screen.

FOV

The Field of View control adjusts the image width. Full, Large, Med. and Small are available. As the image becomes narrower the frame rate increases.

Steer

This control is only available for linear transducers. It steers the B-mode image left or right, without moving the transducer. This can be particularly useful when visualizing needles or other objects that are enhanced by a perpendicular beam.（in Spatial Compounding,

Trapezoid and Panorama states, steer function is not valid）

Trapezoid

The Trapezoid control activates the trapezoid imaging on linear transducer. It is a part of the B-mode function and available in live imaging.

Panorama

The Panorama control invokes the Panorama function. See section

5.1.4 for details.

Image Type

B-mode supports presets for Detail, General, and Penetration. See section 8.3.1.1 for more information.

Frame rate

Adjusts the tradeoff between frame rate and spatial resolution. Higher settings provide more temporal resolution.

Dual B

Press to activate dual imaging mode. Dual L activates the live image on the left side of image field, and Dual R activates the live image on the right side of image field.

Quad

Press to activate quad imaging mode. Refer to section 5.1.3 Quad Imaging for details.

3D/4D

Press to activate 3D/4D imaging mode. Refer to section 5.6 3D/4D mode for details.

Needle

Press to invoke the touch screen menu for Needle Enhancement Visualization and Needle Biopsy Guide functions. See section 7.5 and 7.6 for more information.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Acoustic power*

Adjusts the acoustic output power of the activated transducer. It is only available in live imaging. Higher acoustic power numbers correspond to more brightness and contrast in the image and more force of penetration, but the ALARA principle should be followed in actual situations.

Table 5-2 B-mode Touch Screen Controls

5.1.2. Dual Imaging

Dual Imaging displays images side by side on the screen. During real-time imaging when Dual imaging is enabled, the active image is displayed in real-time and the other image is frozen.

Press the Dual L or Dual R button on the B-mode touch screen to select the left or right image for activation. With both images frozen, press the Dual L or Dual R button to toggle between the

images.

Dual Exit Dual is exited by any of the following:

 Pressing the Dual button corresponding to the currently active side.  Pressing the Quad button.  Pressing the B, M, D hard key.  Pressing the 3D/4D button.  Transducer change, preset recall, or new exam.

Color Doppler is available during dual imaging.

5.1.3. Quad Imaging

Quad Imaging displays images in four quadrants on the screen. During real-time imaging when Quad imaging is enabled, the active image is displayed in real-time and other images are frozen.

Quad imaging is invoked by pressing Quad button on the B-mode touch screen. Quad button is a one-shot button. Each single press on it during real-time imaging activates one of the four images in an order from the top left one to the top right one, then to the bottom left one and to the bottom right one. Each single press on it during frozen status switches among the four images in an order described above but does not change the frozen status of the system.

Quad Exit

Quad is exited by any of the following:

 Pressing the B, M, D hard key.  Pressing the Dual button  Pressing the 3D/4D button  Transducer change, preset recall, or new exam.

Color Doppler is available during Quad imaging.

5.1.4. Panorama

Panorama constructs an extended field of view image as the transducer slides along its long axis.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Panorama is available in live B-mode imaging. To acquire a panoramic image:

 Press the Panorama button on the B-mode touch screen.  Press the Set button on the trackpad to start acquisition.  Slide the transducer along the long axis

The B-mode image will extend to incorporate the newly imaged anatomy.

 When the full anatomy has been acquired, press the Enter button on the trackpad or press

the Freeze hard key. System also will enter the panorama review state when exceeding the default time.

After acquisition the completed Panoramic image is redisplayed to fit on the screen. Measurements*, Comments and Bodymarkers are then supported.

Note:

1. If a measurement function in panorama mode is activated, the caution information of “The accuracy of measurements in Panorama is limited and can be lower than measurements in B-image” in yellow font color appears on the bottom of the image and a caution symbol appears on the head of the measurement results.

2. IMT measurement is not available on panorama image.

Panorama is available only with linear transducers.

Speed Indicator

During an acquisition, a speed indicator bar on the screen will show the current scan speed. Keep the indicator in the green center of the graphic in order to achieve best results.

Most acceptable normal speed too slow too fast

Figure 5-1 Panorama Speed Indicator

5.1.5. Zoom

Zoom is available in live or frozen B-mode and Color imaging. Press the Zoom hard key to zoom an image. There are 2 ways to zoom an image: The Zoom paddle key or a pinch-out gesture on the track pad.

 Zoom Paddle key

o Press the upper part of the Zoom paddle to make the image bigger. o Press the lower part of the Zoom paddle to make the image smaller, down to normal

size.

 Pinch Gesture: Use two fingers on the main part of the trackpad, and move the two fingers

outward from each other (“Pinch-out”). The image will enlarge.

When in Zoom mode, use the trackpad to pan the position of zoomed image. The B image remains zoomed after entering other imaging modes.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Name

Control

Description

Scale

Scale adjusts the range of velocities that are displayed. Upward presses increase scale and downward presses decrease it. Increasing scale when the PW cursor is relatively deep may result in invoking HPRF, if it is configured. See section 5.2.2 for details.

Baseline

The Baseline control adjusts the Doppler baseline. Upward presses move the baseline up on the screen and downward presses move the baseline down.

Invert

Normally signals above the baseline are positive velocities (moving toward the transducers). However, when Invert is pressed then negative velocities are above the baseline. Invert does not affect the baseline position.

Angle Correct

Adjust the Doppler scale to account for the angle between the Doppler cursor and the blood flow. Upward presses increment the angle. Downward presses decrement the angle. Angles above 80 are not allowed.

Quick-Angle

Adjusts the angle correct quickly to one of 60/0/-60.

Filter

The Filter control removes excessive noise from movement of vessel walls. Options of Low, Med. and High are available.

Colorize

Switches between grayscale and colorized (pseudo-color) postprocessing maps.

Gray Map Tint

Adjusts the current postprocessing, either grayscale or tinted

Dynamic Range

The Dynamic Range, or log compression, adjusts how signal intensities are converted to brightness. A high dynamic range presents a flat spectrum, while a low dynamic range presents a large range of spectrum brightness.

5.2 PW-mode

5.2.1. PW Touch Screen Controls

The following touch screen controls impact the PW image. Touch screen controls can be located where you want them to be. See section 3.8 for details.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

SV Size/Gate Size

Gate adjusts the size of the sample volume gate. Upward presses increase the gate size. Downward presses decrease the gate size.

Sweep Speed

Sweep adjusts the sweep speed of the Doppler strip. Options of

Slow, Low, Med., High and Fast are available. Upward presses

increase sweep speed. Downward presses decrease sweep speed.

Strip Size

Format changes the relative size of the Doppler strip compared to the reference image. Full, Large, Med. and Small are available.

Volume

Volume adjusts the audio volume of the Doppler strip. This can be adjusted in pre-Doppler to set the initial volume upon invoking Doppler acquisition.

Duplex (Triplex)

This determines if the strip mode and reference image are imaging simultaneously or not. If the reference image is B-mode

this is labeled “Duplex”. If the reference image includes color this is labeled “Triplex”.

Image Type

Strip Doppler supports image presets for Low Flow, Medium Flow, and High Flow.

Steer

This control is only available for linear transducers. It steers the Doppler cursor angle left or right.

Frequency

This determines the Doppler transmit frequency used for imaging.

Auto Trace

Press to activate the Auto Trace function on a real-time or frozen PW Doppler strip.

The Auto Trace function automatically traces the spectral Doppler waveform and records several measurements on selected general imaging. See section 7.3.1 for details.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Auto Trace Direction

Press to specify which side of the Doppler baseline to take measurements from. there are 3 options:

Up: traces positive portion of waveform (above baseline). Down: traces negative portion of waveform (below baseline). Both: traces waveform on both sides of baseline.

Acoustic power*

Adjusts the acoustic output power of the activated transducer. It is only available in live imaging. Higher acoustic power numbers correspond to more brightness and contrast in the image and more force of penetration, but ALARA principle should be followed in actual situations.

Auto Optimization*

The Auto push button automatically updates the PW gain, DR, baseline and PRF scale. Each single press of the button renews the automatic optimization. Whether Gain, DR or Scale/Baseline is optimized when pressing Auto button can be configured in Set-up. See section 9.1.4 for detail.

Table 5-3 PW Mode Touch Screen Controls

5.2.2. HPRF

Conventional PW Doppler scales are limited by the Nyquist limit. High Pulse Repetition Frequency (HPRF) allows the system to exceed the Nyquist limit by having multiple Doppler pulses in the body at the same time. In HPRF imaging multiple Doppler gates are displayed, since the multiple Doppler pulses could be giving information from different depths. HPRF is automatically invoked when needed to maintain the requested depth and scale. For example, if the system is at a high scale and you move the cursor deeper the system may automatically invoke HPRF. This can also happen if the cursor is deep and you increase scale.

If HPRF is active you will see multiple Doppler gates on the reference image. If you do not want to be in HPRF, decrease the scale or move the cursor to a more shallow location until only one gate is displayed.

5.2.3. Update

The Update hard key toggles between acquiring Doppler strip and acquiring the reference image.

5.3 CW-mode

Depending on system configuration, CW may be available on the P5-1XQ transducer. There are two ways to invoke CW:

 Press the CW button on the Doppler touchscreen to switch between PW and CW modes.  Configure the F1 or F2 programmable hardkey to invoke CW directly (see section 9.1 for

details).

5.3.1. CW Touch Screen Controls

The following touch screen controls impact the CW image. Touch screen controls can be located where you want them to be. See section 3.8 for details.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Name

Control

Description

Scale

Scale adjusts the range of velocities that are displayed. Upward presses increase scale and downward presses decrease it.

Baseline

The Baseline control adjusts the Doppler baseline. Upward presses move the baseline up on the screen and downward presses move the baseline down.

Image Type

Strip Doppler supports image presets for Low Flow, Medium Flow, and High Flow.

Invert

Angle Correct

Quick-Angle

Adjusts the angle correct quickly to one of 60/0/-60.

Filter

The Filter control removes excessive noise from movement of vessel walls. Options of Low, Med. and High are available.

Colorize

Switches between grayscale and tinted (pseudo-color) postprocessing maps.

Gray Map Tint

Adjusts the current postprocessing, either grayscale or tinted.

Dynamic Range

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Sweep Speed

Sweep adjusts the sweep speed of the Doppler strip. Options of Slow, Low, Med., High and Fast are available. Upward presses increase sweep speed. Downward presses decrease sweep

speed.

Strip Size

Format changes the relative size of the Doppler strip compared to the reference image. Full, Large, Med. and Small are available.

Volume

Volume adjusts the audio volume of the Doppler strip. This can be adjusted in pre-Doppler to set the initial volume upon invoking Doppler acquisition.

Name

Control

Description

Color Mode Variation

A set of radio-buttons display the color modes that are available on the current transducer, and let you switch between them. See section 5.4.2 for details.

Scale

Scale adjusts the range of velocities that are displayed. Upward presses increase scale and downward presses decrease it. It is available in Velocity, PDI, and DPDI. It is not available in Freeze/Cine.

Baseline

The Baseline control adjusts the Color baseline. Upward presses move the baseline up on the scale and downward presses move the baseline down.Baseline is not available in PDI mode.

Invert

Table 5-4 CW Mode Touch Screen Controls

5.4 Color-mode

5.4.1. Color Touch Screen Controls

The following touch screen controls impact the color image. Touch screen controls can be located where you want them to be. See section 3.8 for details.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Wall Filter

The Filter control removes excessive noise from movement of vessel walls. Options of Low, Med. and High are available.

Map

Adjusts the current map for the active color variation.

Persist

Persistence determines the number of frames that are averaged together for display. Levels of Off, Low, Med. and High are available.

Smooth Filter

The smoothness filter determines the spatial filtering that is applied to the Color image. Higher filter levels create a smoother image. Upward presses increase the filter. Downward presses decrease the filter.

Threshold

When the system receives both B-mode and CD signal from a region the threshold determines whether to display that as grayscale or color. Higher values mean a stronger CD signal is needed to display it in color. Upward presses increase threshold. Downward presses decrease threshold.

Frequency

Frequency determines the transmit frequency used by color Doppler. Upward presses increase the frequency. Downward presses decrease the frequency.

Steer

This control is only available for linear transducers. It steers the Color ROI box angle left or right.

Image Type

Color Doppler supports image presets for Low Flow, Medium Flow, and High Flow.

Dual Live

To activate split screen with simultaneous live B/Color and live B. the live B image without color and the same live B image with color are simultaneously displayed on each side of the image field.

Freezing the image will freeze both sides simultaneously. Cine review will review both sides simultaneously.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Dynamic Range

Frame rate

Adjusts the tradeoff between frame rate and spatial resolution. Higher settings provide more temporal resolution.

Acoustic power*

Adjusts the acoustic output power of the activated transducer. It is only available in live imaging. Higher acoustic power numbers correspond to more brightness and contrast in the image and more force of penetration, but ALARA principle should be followed in actual situations.

Name

Control

Description

Colorize

Switches between grayscale and colorized (pseudo-color) postprocessing maps.

Gray Map Tint

Adjusts the current postprocessing, either grayscale or tinted.

Table 5-5 Color Mode Touch Screen Controls

5.4.2. Color Mode Variants

The Acclarix AX8 system supports 3 types of Color Doppler imaging:

 Color (Color Doppler): This is velocity Color Doppler that shows direction and velocity

of flow. Different colors represent different velocities, and positive flow has different colors than negative flow.

 PDI (Power Doppler Imaging): PDI shows the power, or intensity, of the Doppler signal.

PDI is typically more sensitive to low levels of flow, but can not distinguish the velocity or direction of the flow.

 DPDI (Directional Power Doppler Imaging): This is similar to DPI in that it shows the

power of the Doppler signal instead of the velocity. However, it does map positive flow to different colors than negative flow.

5.5 M-mode

5.5.1. M-mode Touch Screen Controls

The following touch screen controls impact the M-mode image. Touch screen controls can be located where you want them to be. See section 3.8 for details.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Dynamic Range

Focus Pos

The focus position set in B-mode applies to M-mode as well. Upward presses move the focus shallower, regardless of the U/D invert status of the M-mode. Downward presses move the focus deeper.

Sweep Speed

Sweep adjusts the sweep speed of the M-mode strip. Options of Slow, Low, Med High and Fast are available. Upward presses increase sweep speed. Downward presses decrease sweep

speed.

Strip Size

Format changes the relative size of the M-mode strip compared to the reference image. Full, large, Med and small are available.

Side-by-side

This is an on/off control. When On, the M-Mode strip is side-by-side with the B-mode image. When Off, the M-Mode strip is below the B-mode image

Line Persistence

The line Persistence determines how many M-mode lines are averaged together for the display, similar to persistence in B-Mode. Levels of Off, Low, Med and High are available.

Frequency

Frequency determines the transmit frequency used by M-Mode. Upward presses increase the frequency. Downward presses decrease the frequency.

Acoustic power*

Adjusts the acoustic output power of the activated transducer. It is only available in live imaging. Higher acoustic power numbers correspond to more brightness and contrast in the image and more force of penetration, but ALARA principle should be followed in actual situations.

Table 5-6 M-Mode Touch Screen Controls

5.6 3D/4D Mode*

Depending on the system configuration and regulatory approval, 3D/4D may be available on the C5-2MQ* transducer. The first step in using 3D or 4D is to activate pre-3D mode. There are two ways to activate pre-3D mode:

1. Press the 3D/4D button on the touch screen in B-mode.

2. Configure the F1 or F2 hard key to invoke 3D/4D. There are two options to do so, one

labeled „3D‟ and the other „4D‟. These both invoke pre-3D, but with different defaults for 3D

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Name

Control

Description

Image quality

Adjusts the trade-off between speed and quality of the acquisition. Settings include High (quality), Medium, and Fast.

Angle

Adjusts the angle of the volume acquisition. Upward presses increment the angle. Downward presses decrement the angle. Angle range is from 5ºto 70º in increments of 5º.

Baby Spine/ Baby Face

These two radio buttons determine if the acquisition is optimized for looking at a Baby Spine (Maximum Intensity Projection), or a Baby Face (Surface Render). Thresh (only in surface render mode), bright and contrast will be adjusted

and 4D.

NOTE: Measurement function is not available in 3D/4D.

5.6.1. Pre-3D

The Pre-3D mode supports defining the 3D/4D acquisition location and settings. Figure 5-2 shows an example of the pre-3D image. The ROI (Region of Interest) indicates the

portion of the image that will be used for 3D/4D. The position/size of the ROI can be adjusted using the trackpad and Set key. Also note that there is a horizontal line going across the ROI near the top and it can be adjusted to a curved line upwards and downwards by using the trackpad. This is the clip plane. The initial volume rendering will show everything below this line.

Figure 5-2 Pre-3D Image

The touch screen controls in pre 3D interface:

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

automatically.

3D/4D

These two radio buttons determine if the acquisition will be 3D or 4D.

Start

Start an acquisition. If 3D was highlighted then a single volume is acquired. If 4D was highlighted then continuous acquisitions are started.

Exit

Exit 3D/4D

Table 5-7 Pre-3D Touch Screen

5.6.2. 3D Volume Sweeping

During the process of 3D volume sweeping, the images swept in ROI box are displayed in the image area.

Figure 5-3 3D Image Scanning

While scanning, the sector in the right bottom is filled gradually，and no buttons on the control panel and touch screen can be activated.

5.6.3. 3D Image Review

If 3D was selected, then the system will enter to the 3D review status after finishing one sweep.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Name

Control

Description

Volume

These two radio buttons toggle between the Volume display and the Multi-Slice display.

A/B/C/3D

These four radio buttons select which quadrant is the focus of the navigation/panning controls. A/B/C are three

orthogonal slices through the volume, while „3D‟ is the

rendered image.

Single, Dual, Quad

These three radio buttons switch the display to show 1, 2, or 4 images at once. Single shows the 3D image, dual shows the A slice and 3D image, Quad shows three MPR slices and 3D image.

Reset

Reset the operation of pan, rotate and zoom to the initial condition.

Pan

Pan image along the x-axis or y-axis of the activated window. Use the trackpad to pan image along x-axis and

Figure 5-4 3D Image Review

 There are two image modes: Volume imaging mode and multi-slice imaging mode. Figure

5-4 shows Volume Imaging Mode in quad screen with a Baby Face volume rendering.

 Quadrant A shows a slice through the data that mimics the original ultrasound image.  Quadrant B is orthogonal to A, as if the transducer had been rotated 90 degrees.  Quadrant C is orthogonal to A and B, showing a slice that is parallel to the transducer

face.

The icon at the bottom-right shows the position of each slice with respect to the full 3D data set.

The following table shows the controls that are available in Volume Imaging Mode

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

y-axis.

VOI

Press to activate the function of adjusting VOI or clip

plane. Use the trackpad to adjust and press Set to switch between VOI and clip plane.

Cut

Function of cut. After activating this button, the 3D image is selected, press Set to locate the start point, use trackpad to trace and second press Set to locate the end point The region within these two points will be cut. The system will draw a straight line between the start and end point to enclose the cut region.

Undo

Undo the previous cut operation

Redo

Redo the previous undo operation

Undo All

Return to the condition before cutting

Threshold

Adjust the threshold of surface render mode, Upward presses increase threshold. Downward presses decrease threshold.

Bright.

Adjust the bright of 3D image

Contrast

Adjust the contrast of 3D image.

3D Smooth/

MPR Smooth

Adjust smoothness of A\B\C slices and 3D images. Higher filter levels create a smoother image. Upward presses increase the filter. Downward presses decrease the filter.

Rotation

Quickly rotate the image. Available angles are: 0°/90° /180 °/270° .

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Rotation X

Rotate the image by the X-axis of the activated window.

Rotation Y

Rotate the image by the Y-axis of the activated window.

Rotation Z

Rotate the image by the Z-axis of the activated window. New

Volume

End the 3D volume sweeping and return to the pre-3D interface

Exit

Exit 3D/4D

MPR Review

MPR (multi-planar reconstruction) review function. After this button is activated, the 3D image is hidden, two perpendicular lines appear on the selected quadrant.

These two lines are color matched with the other 2 MPR quadrants, and show where the three planes intersect. Left/right trackpad movement moves one of these lines while up/down moves the other line.

3D Tint

Select 3D tint, options of Clear，Candle，Copper，Sepia， Gold.

MPR Tint

Select MPR tint, options of Gold, Sepia, Blue, Ice and Clear are available.

Table 5-8 Volume imaging Mode Touch Screen

Image area and touch screen controls in multi-slice imaging mode:

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Control

Name

Description

A/B/C

These three radio buttons determine which slice isthe required parallel slice. These three choices are the same as on the Volume display in quad mode.

3*3, 2*2, 3*2

These three radio buttons determine the layout of the display. Pan

Pan the basis slice along the x-axis or y-axis of the activated window. Use the trackpad to pan the basis slice along x-axis y-axis. Parallel slices change with the pan operation.

Reset

Reset the operation of pan, rotate and zoom to the initial condition.

Number

Select how many slices to use

Figure 5-5 Multi-slice Imaging Mode

In figure 5-5, the first image shows the basis slice, other images are orthogonal to the basis slice and parallel to each other. Lines on the basis slice indicate the locations of the parallel slices. If there are more slices than images then the un-displayed slices are shown with a dotted line. A number below each parallel slice shows the slice location in the basis slice, with 0 being the middle slice.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Distance

Adjust the distance between slices.

When there are more slices than can be displayed at once this control cycles through the subset of slices displayed.

Tint

Select multi-slice tint, options of Gold, Sepia, Blue, Ice and Clear are available.

Smooth

Adjust smoothness of A\B\C slices. Higher filter levels create a smoother image. Upward presses increase the filter. Downward presses decrease the filter.

Rotation X

Rotate the basis slice by the X-axis of the activated window. Parallel slices change with the rotation operation.

Rotation Y

Rotate the basis slice by the Y-axis of the activated window. Parallel slices change with the rotation operation.

Rotation Z

Rotate the basis slice by the Z-axis of the activated window. Parallel slices change with the rotation operation.

Table 5-9 Multi-slice Mode Touch Screen

5.6.4. 4D Volume Acquisition

Press 3D/4D button on the touch screen in B-mode to enter pre-3D, select 4D, select Baby Spine or Baby Face fist and use the ROI box to set the region. Only ROI will be stored during the volume sweep. Use the trackpad to set the size and location of the ROI box. Press Set to confirm. Use the trackpad to set the edge of VOI (Volume of interest) and press Start button on the touch screen or the Enter button on the trackpad to begin sweep.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Imaging

Name

Control

Description

cine

Switch between 3D and 4D review state

5.6.5. 4D Live Volume

4D Live volume continuously sweeps and displays successive 3D volumes. During live 4D imaging the following controls are available: activate any window of A/B/C/3D,

Single/Dual/Quad，VOI, Threshold, Bright, Contrast, 3D Smooth/ MPR Smooth, 3D Tint/ MPR Tint, Rotation, Rotation X, Rotation Y, Rotation Z , Zoom and Gain in B mode.

Figure 5-6 4D Volume Sweeping Image

As shown in figure above, image in the left is A slice and image in the right is the live 4D volume rendering.

5.6.6. 4D Cine

During the process of 4D live volume imaging; press the Freeze button on the control panel to enter the 4D cine mode. A cine replay scroll bar appears below the images. Use the trackpad to replay the reset 3D images. For the selected frame, user can execute all operations that are available 3D review status. Press Freeze again to return to the live image.

Touch screen controls are the same as that of static 3D except for Cine button.

Figure 5-7 4D Cine

Table 5-10 4D Touch Screen

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Acclarix AX8 Diagnostic Ultrasound System User Manual Transducer

No.

Model

Type

Application

C5-2XQ/ C5-2Q

Convex

Abdomen Fetal / Obstetrics Urology Gynecology

Musculo-skeletal Nerve

E8-4Q

Endocavity

Fetal / Obstetrics Endo-vaginal

Endo-rectal : Urology

L10-4Q

Linear

Small Parts (Thyroid, Testes, Breast) Peripheral Vascular Musculo-skeletal Neurology

L12-5Q

Linear

Small parts (Thyroid, Testes, Breast) Vascular Musculoskeletal Neurology

L17-7HQ

Linear

Small Parts (Thyroid, Testes, Breast) Peripheral Vascular Musculo-skeletal Neurology

L17-7SQ

Linear

Intra-operative Musculo-skeletal Nerve

Vascular

MC8-4Q

Micro Convex

Pediatric Neonatal (including abdominal and cephalic) Neurology Vascular

P5-1XQ

Phase array

Adult Cardiac Abdomen Pediatric Cardiac

Adult cephalic*

C5-2MQ*

Convex

Fetal / Obstetrics

6 Transducers

6.1 Transducer Model

Table 6-1 Transducer Model & Application

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Acclarix AX8 Diagnostic Ultrasound System User Manual Transducer

Name

Function

Transducer head

Converts electrical signals to sound waves, and then converts received echoes back to electrical signals. The tip of the transducer is the acoustic lens.

Transducer cable

Transmits electrical signals between the transducer head and the transducer connector.

Transducer connector

Connects the transducer to the ultrasonic diagnostic system

Transducer head

Transducer connector

Transducer cable

6.2 Name and Function of Each Part of the Transducer

Figure 6-1 shows an example of a transducer.

Figure 6-1 Typical transducer

6.3 Transducer Cleaning and Disinfecting

Transducers should be cleaned and/or disinfected as necessary or between use with a recommended cleanser or disinfectant. Disconnect the transducer from the system prior to cleaning and disinfecting.

The validated cleaning agents for cleaning the transducers are:

 Mild near neutral detergent  Ethanol (75%)  Isopropanol (70%)

Cleaning agents should be applied and removed using a clean, soft, non-abrasive cloth or paper towel.

The validated disinfectants for transducer are:  Ethanol (75%)

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Acclarix AX8 Diagnostic Ultrasound System User Manual Transducer

 Isopropanol (70%)  OPA (0.55%)

If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required for the disinfection step.

WARNING

1. Unplug the transducer from the system prior to cleaning or disinfecting.

2. To avoid infection, always use protective gloves when performing cleaning and disinfecting procedures.

3. To avoid infection, ensure that expiration date of the disinfecting solution has not passed.

To clean the transducers:

1. Disconnect the transducer from the system.

2. Wipe the patient contact area with a soft cloth dampened with the cleaning solution until no

visible contaminants remain.

3. Wipe off the cleaning solution with a fresh cloth or towel, dampened with tap water after

cleaning until no visible cleaning agent remains.

4. Wipe off with a dry cloth to remove residual moisture.

5. Leave the transducer to air dry.

NOTE：A single-use sheath should be used on E8-4Q transducer. Before cleaning the transducer, remove the sheath gently and discard it. Put on a new single-use sheath before using the transducer.

CAUTION

1. Always wear gloves to perform the following steps.

2. To minimize the disease transmission, use of legally marketed, sterile transducer and sheath is strongly recommended for intra-cavitary and intra-operative procedures. Legally marketed, sterile, pyrogen free transducer sheath is required to use for neurological intra-operative procedures.

3. DO NOT use an expired transducer sheath. Check whether the term of validity has expired prior to using transducer sheaths.

4. The single-use sheath should comply with the local regulations.

To install transducer sheath:

1. Place an adequate amount of sterile coupling gel on the acoustic window of the transducer;

2. Insert the transducer into the sheath;

3. Pull the sheath over the transducer and cable until the sheath is fully extended;

4. Secure the sheath using the bands or clips supplied with the sheath;

5. Check and eliminate bubbles between the face of the transducer and the sheath. Bubbles

between the face of transducer and the sheath may affect the ultrasound imaging.

6. Inspect the sheath to ensure that there are no damages (i.e. holes or tears).

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Acclarix AX8 Diagnostic Ultrasound System User Manual Transducer

C5-2XQ/

C5-2Q

P5-1XQ

L17-7SQ

L17-7HQ

L10-4Q/

L12-5Q

Disinfectant

E8-4Q

MC8-4Q

C5-2MQ*

There are two methods to disinfect the transducer (use the immersion method for the E8-4Q and L17-7SQ):

Non-immersion:

1. Disconnect the transducer from the system.

2. Prepare the disinfectant solution (75% ethanol or 70% isopropanol).

3. Spray the solution to the transducer interface or wipe it with a soft cloth dampened with the

disinfectant solution.

4. Rinse the transducer according to the disinfectant instructions. Wipe the transducer with a dry

cloth or leave the transducer to air dry.

5. Inspect the transducer to ensure that there is no damage.

Immersion:

1. Prepare the disinfectant solution （Cidex OPA）

2. Place the cleaned and dried transducer in contact with the disinfectant (refers to figure 6-2 for

the contacting area) for the time specified by the disinfectant manufacturer.

3. Rinse the transducer according to the disinfectant instructions. Wipe the transducer with a dry

cloth or leave the transducer to air dry.

4. Inspect the transducer to ensure that there is no damage.

1. Do not immerse the transducer connector. If the cable connector is immersed, do not

Figure 6-2 Depth of the Transducer Immerged into Disinfectant

WARNING

plug the connector into the system. Rinse the connector under running water and dry it thoroughly. If necessary, contact EDAN for service.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Transducer

2. Prohibit infiltration of any type of liquid into the device or the transducer.

3. Do not sterilize the transducer using techniques such as autoclave, ultraviolet, gamma

radiation, gas, steam, or heat. Severe damage May result.

4. Use only ultrasound coupling gel that complies with local regulations.

5. Do not immerse the AC adapter and connector of the transducer into solutions.

Transducers can be submerged to, but not including, the strain relief of the transducer array. Do not immerse or soak any part of a transducer in any cleaning material not listed in the recommended list of disinfectant.

6. Use the Cidex OPA immersion method to disinfect the endocavity transducer.

7. Only non-immersion method can be used with solution of ethanol or isopropanol. The

solution concentration should not exceed the value provided above.

8. The immersion time should not exceed the time that is specified by the disinfectant

manufacturer.

9. Patient contact area should be immersed into the solution while using the immersion

method, but should not exceed the depth shown in figure 6-2.

Proper Use of Transducers

In order to extend the service life and to obtain optimum performance of the transducer, please operate as follows:

Inspect AC adapter, socket and acoustical window of the transducer periodically. Shut down the machine before connecting or disconnecting the transducer. Do not drop the transducer onto the floor or collide with hard objects. Otherwise it will be

damaged easily. Do not heat the transducer. Do not pull or bend the transducer cable. Coupling gel can only be used on the head of the transducer, and it should be wiped off after use. Clean and disinfect the transducer after every use. The acoustical window and the shell of the transducer should be examined frequently.

CAUTION

1. Do not disinfect or clean transducers under high temperature, and the temperature

should be below 45°C.

2. In order to avoid damaging the device, the disinfection method is limited to regular

maintenance of devices in hospitals. Disinfecting instruments should be cleaned first.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Features

Button

Description

Home

Set the cursor in a pre-defined location.

Set Home

Set the current cursor location as the new Home location

Move Block

Select comments for moving to desired locations

Delete

Delete a whole text or text group or an arrow

Delete All

Clear all comments on the image area

Arrow

Create a new arrow for annotating

Keyboard

Toggle between showing pre-defined comments(comment library) or a touch screen keyboard

7 Features

7.1 Comments

The Comments function lets you add annotation to an image. The Comment function is invoked by pressing the Comment hard key on the console. Figure 7-1 shows an example touch screen for Comments. The top portion of the screen shows comments that are pre-defined in pre-sets. See section 8 for details on how to configure these. The bottom portion of the screen shows controls available while the Comment function is active. Table 7-1 gives an overview of these controls.

Figure 7-1 Comment Touch Screen

Table 7-1 Comment Touch Screen Description

Adding comments

You can add either pre-defined comments or use a keyboard.

Adding comments using the keyboard

1. Invoke the Comment function.

2. Press the “Keyboard” touch screen key to display a keyboard on the touch screen.

3. Move the cursor to the desired location and enter the desired text.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Features

Adding comments using pre-defined comments

1. Invoke the Comment function

2. Move the cursor to the desired location and press the desired pre-defined comment.

Some of the pre-defined comments may be grouped together with a border surrounding them

(such as „Rt‟ and „Lt‟ in figure 7.1). These are special keys that let you quickly replace one term with another, regardless of where the cursor is within a block of text. For example, if

you had entered “Rt. Kidney” as a block of text, pressing the “Lt.” button would change that

block to “Lt. Kidney” even if the cursor is not at the specific location.

Adding arrows

1. Invoke the Comment function

2. Press Arrow button on the touch screen to display an arrow at the current cursor location.

3. Move the arrow to the desired location. Note that while the arrow is being moved the

orientation of the arrow is fixed.

4. Press the Pos/Angle button to set the tip of the arrow in its current location and toggle

adjusting the angle of the arrow. The trackpad can now be used to rotate the arrow. The Pos/Angle button can be used to toggle between moving the head of the arrow and moving the tail of the arrow. The selected button is yellow colorized in the background.

5. Press the Enter button to complete the arrow. You can now enter text at the end of the arrow.

Modifying comments

1. Move the cursor to a desired comment, notice that an insert cursor appears in the text as the

cursor moves over an existing block of text. Enter text using either the keyboard or pre-defined comments. The new comments will be

added to the old text.

Deleting comments

There are several ways to delete comments:

 Move the cursor to the desired block of comments and press the Delete button on the touch

screen to delete that block of comments.

 Press the Delete All button on the touch screen to remove all comments.  Press the Clear hard key on the console to remove all comments, bodymarkers, and

measurements.

7.2 Body Mark

The Body Mark lets you add a bodymarker graphic to an image and indicate the location of the transducer using a transducer icon on that graphic. The Body Mark function is invoked by pressing the Body Mark hard key on the console. Figure 7.2 shows an example touch screen for Body Mark. The main portion of the screen shows a grid of bodymarkers that are pre-defined in pre-sets. See section 8 for details on how to configure these. The bottom portion of the screen shows controls available while the Comment function is active. Table 7-2 gives an overview of these controls.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Features

Button

Description

Delete

Delete the graphics on the image area

Angle

Rotates the transducer icon on the bodymarker graphic.

Figure 7-2 Body Mark Touch Screen

Table 7-2 Body Mark Touch Screen Description

Adding a body mark:

1. Invoke the Body Mark function The default bodymarker graphic appears on the main screen, with the transducer icon shown

in the default position.

2. Select a desired bodymarker graphic on the touch screen, that graphic replaces the default.

3. Move the transducer icon as needed. The orientation of the transducer icon can be changed

with the Angle touch screen key.

Moving the transducer icon:

1. Press Probe/Graphic to toggle moving the transducer icon.

The transducer icon can not be moved outside of the bodymarker graphic area.

2. Press Probe/Graphic to confirm the new position of the transducer icon and toggle moving

the bodymarker graphic. Probe/Graphic button can be used to toggle between moving the transducer icon and moving

the bodymarker graphic. The selected button is yellow colorized in the background.

Deleting a body mark:

There are two ways of deleting a bodymarker graphic:

 Press Delete on the touch screen to delete the graphics on the image area.  Press the Clear hard key to delete all bodymarkers, comments, and measurements.

7.3 Measurements

NOTE: This section provides general introduction of generic and application

measurements. For details about specific application measurements and calculations, please refer to the Acclarix AX8 Advanced Manual.

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The Measure function lets you perform measurements on a live or frozen image. The Measure function is invoked by pressing the Measure hard key on the console. Figure 7-3 shows an example touch screen for Measure.

There are two types of measurements: Generic Measurements: These are simple tools like Distance or Area. There is no specific

anatomy associated with these measurements and they do not appear in a report. Application Measurements: These are measurements for specific anatomy or clinical conditions.

The results can be entered into a report that can be printed later. On the Measure touch screen the lower part of the touch screen shows Generic Measurements.

These are different for each imaging mode, but are the same for all presets. The upper part of the touch screen shows Application Measurements. These are different for each imaging mode and each preset. See section 8 for details on how to configure these.

Figure 7-3 Measure Touch Screen

Tool Options

Some measurements can be done with a choice of different tools, and each tool has a choice of multiple output result items. The users can configure the default tool and result items for these measurements by Tool Options. For result options, at least one item should be selected.

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Figure 7-4 Tool Options Touch Screen

Moving the measurement result window

The measurement result window is displayed on the top left corner of the image field by default, the system supports changing the display position of the result window by dragging it.

To change the display position of result window:

1. Press Cursor hard key to invoke a cursor after a measurement is done.

2. Move the cursor over the result window, and press Set key, the result window will turn

green.

3. Move on the track pad to locate a desired position within the image field for the result

window.

4. Press Set key again to fix the result window on the new position.

The system supports a different result window position for each image mode.

Note: The measurement result window cannot be moved when measure in review state.

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Figure 7-5 Moving the Measurement Result Window

7.3.1. Generic Measurements

A default generic measurement is automatically started when Measure is invoked. Each imaging mode supports several types of measurements, as described below. You can switch between these types using the touch screen buttons along the bottom of the touch screen. Some generic measurements have options, for the method to perform the measurement. When the current generic measurement has options available you can view and change those options through the Tool Options touch screen buttons.

7.3.1.1. B-mode Generic Measurements

The Acclarix AX8 supports the following types of generic B-mode measurements:

 Distance  Circ/Area  Angle  Volume  Stenosis

Distance: The distance measurement is always done with a caliper pair.

To measure Distance with a caliper pair:

1. Invoke the measure function on a B-mode image.

2. If Distance is not the default measurement, select Distance from the touch screen.

3. Move the caliper to the desired location.

4. Press the Set key to place that caliper and add the second half of the caliper pair.

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Further presses of the Set key toggle which side of the caliper can be moved. Pressing the Enter key completes the caliper and allows you to create another tool.

Circ/Area: Area and Circumference can be measured with an Ellipse or Trace

To measure Area or Circumference with an Ellipse:

1. Invoke the measure function on a B-mode image.

2. If Area is not the default measurement, select Area from the touch screen.

If Ellipse is not the default tool, press Tool Options to switch to Ellipse

3. Move the caliper to the desired location.

4. Press the Set key to place that caliper and add the second half of the caliper pair.

5. Press the Set key to place the second half of the caliper. An ellipse appears and can be

adjusted with the trackpad. Further presses of the Set key toggle between controlling each side of the ellipse caliper and the ellipse diameter. Pressing the Enter key completes the caliper and allows you to create another tool.

To measure Area or Circumference with a Trace:

1. Invoke the measure function on a B-mode image.

2. If Area is not the default measurement, select Area from the touch screen.

If Trace is not the default tool, press Tool Options to switch to Trace. Trace can be done with a Draw option. Draw will follow your movements.

3. Move the caliper to the desired location.

4. Press the Set key to place the caliper and start drawing the trace.

5. Moving the caliper now leaves behind a trail of dots to mark the trace outline

6. Press the Enter key to complete the trace.

Angle: The Angle measurement is always done with an angle tool.

To measure Angle:

1. Invoke the measure function on a B-mode image.

2. If Angle is not the default measurement, select Angle from the touch screen.

3. Move the caliper to the vertex of the angle you are measuring.

4. Press the Set key to place that point and create a new caliper. Move that to one end of the

angle.

5. Press the Set key to place that end and create a new caliper. Move that to the other end of

the angle. Further presses of the Set key toggle between controlling each of the three points that make up the angle. Pressing the Enter key completes the angle and allows you to create another tool.

Volume: Volume can be measured with 3 Distance.

To measure Volume with 3 Distance:

1. Invoke the measure function on a B-mode image.

2. If Volume is not the default measurement, select Volume from the touch screen.

Move the caliper to the desired location.

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3. Press the Set key to place that caliper and add the second half of the first caliper pair.

4. Further presses of the Set key toggle which side of the caliper can be moved. Pressing the

Enter key completes the first caliper pair and creates the second caliper pair.

5. Repeat step 3~5 to complete the second caliper pair and create the third caliper pair.

6. Repeat step 3~5 to complete the third caliper pair and allow you to create another tool.

Stenosis: Stenosis can be measured with Caliper Pairs, Ellipses, or Traces To measure Stenosis with Caliper Pairs:

1. Invoke the Measure Function on a B-mode image.

2. If Stenosis is not the default measurement, select Stenosis from the touch screen.

If Caliper is not the default tool, press Tool Options to switch to Caliper.

3. Move the caliper to the desired location.

4. Press the Set key to place that caliper and add the second half of the caliper pair.

5. Further presses of the Set key toggle which side of the caliper can be moved. Pressing the

Enter key completes the caliper and creates the second caliper pair tool.

6. Repeat step 3~5 to complete the second caliper pair and allow you to create another tool.

To measure Stenosis with Ellipses:

1. Invoke the Measure Function on a B-mode image.

2. If Stenosis is not the default measurement, select Stenosis from the touch screen.

If Ellipse is not the default tool, press Tool Options… to switch to Ellipse.

3. Move the caliper to the desired location.

4. Press the Set key to place that caliper and add the second half of the caliper pair.

5. Press the Set key to place the second half of the caliper. An ellipse appears and can be

adjusted with the trackpad.

6. Further presses of the Set key toggle between controlling each side of the ellipse caliper

and the ellipse diameter. Pressing the Enter key completes the first Ellipse and creates the second Ellipse tool.

7. Repeat step 3~6 to complete the second Ellipse and allow you to create another tool.

To measure Stenosis with Traces:

1. Invoke the Measure Function on a B-mode image.

2. If Stenosis is not the default measurement, select Stenosis from the touch screen.

If Traces is not the default tool, press Tool Options to switch to Traces.

3. Move the caliper to the desired location.

4. Press the Set key to place the caliper and start drawing the trace.

5. Moving the caliper now leaves behind a trail of dots to mark the trace outline

6. Press the Enter key to complete the trace.

7. Repeat step 3~6 to complete the second trace and allow you to create another tool.

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7.3.1.2. Strip Doppler Generic Measurements

The Acclarix AX8 supports the following types of generic strip Doppler measurements:

 Caliper  Trace  Auto Trace  HR (Heart Rate)  RI (Resistive Index)

Caliper: The Caliper measurement can provide a wide range of results. To use the Caliper measurement:

1. Invoke the Measure Function on a Doppler strip.

2. If Caliper is not the default measurement, select Caliper from the touch screen.

3. Move the caliper to the desired location. At this point the measurement can display the

following results (the actual results shown will depend on the preset):

 Vel  PG

4. If you want a caliper pair, press the Set key to place the caliper and add the second half of

the caliper pair. At this point the measurement may display the following results (the actual results shown will depend on the preset):

 V1  V2  RI  S/D  Time  ΔV  Accel  PG1  PG2  PHT

Further presses of the Set key toggle which side of the caliper can be moved. Pressing the Enter key completes the caliper and allows you to create another tool. The S/D, PI, and PHT results assume that the first caliper is placed on the peak systolic point.

Trace: The Trace measurement can provide a wide range of results.

To use the Trace measurement:

1. Invoke the Measure Function on a Doppler strip.

2. If Trace is not the default measurement, select Trace from the touch screen.

3. Trace can be done with a Draw. Draw will follow your movements

4. Move the caliper to the desired start point.

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5. Press the Set key to place the start point and start drawing the trace.

6. Moving the caliper now leaves behind a trail of dots to mark the trace outline. Press the

Set key to adjust the positions of the PS or ED points in the trace.

7. Press the Enter key to complete the trace.

8. At this point the trace measurement may display the following results (the actual results

shown will depend on the preset):

 PS  ED  MD  TAMax  PGmax  PGmean  PI  RI  S/D  VTI  Time  AT  DT

NOTE: Measure trace can only be active in image frozen status. Auto Trace: Auto Trace is capable of determining the maximum and/or mean blood flow in

freeze mode. Each result that it calculates is associated with either the maximum or the mean value. For activate auto trace in real time mode, press Auto Trace button in PW touch screen.

To use the Auto Trace measurement:

1. Invoke the Measure Function on a Doppler strip.

2. If Auto Trace is not the default measurement, select Auto Trace from the touch screen. The trace waveform(s) automatically appear. If any maximum-related results are enabled then

the maximum value waveform is displayed on the Doppler strip. If any mean-related results are enabled then the mean value waveform is displayed.

3. The Trace measurement may display the following results (the actual results shown will

depend on the preset):

 PS  ED  MD  TAMax  TAMean  PGmax  PGmean  PI  RI  S/D  VTI  Time  AT  DT

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 HR NOTE: Measure Auto trace can only be active in image frozen status. Live auto trace is available as a separate feature from the Doppler touch screen.

HR：The HR measurement can provide the heart rate calculation by measured the time of the heart beat cycles.

To use the HR measurement：

1. Invoke the Measure Function on a Doppler strip.

2. If HR is not the default measurement, select HR from the touch screen.

3. Move the caliper to position the first heart beat. Press the Set key to activate a second

caliper.

4. Move the second caliper to position the next beat.

5. Press the Enter key to complete or press the Set key to switch moving the first caliper.

6. The HR measurement can display the following result(the actual results shown will

depend on the preset):

 HR RI: The RI measurement can measure the PS and ED to calculate the result of RI and S/D.

To use the RI measurement：

1. Invoke the Measure Function on a Doppler strip.

2. If RI is not the default measurement, select RI from the touch screen.

3. Move the caliper to position the PS point. Press the Set key to activate a second caliper.

4. Move the second caliper to position the ED point.

5. Press the Enter key to complete or press the Set key to switch moving the first caliper.

6. The RI measurement can display the following results (the actual results shown will

depend on the preset):

 PS

 ED

 RI

 S/D

7.3.1.3. M-mode Generic Measurements

The Acclarix AX8 supports the following types of generic M-mode measurements:

 Caliper  HR (Heart Rate)

Caliper: The Caliper measurement can provide a wide range of results.

To use the Caliper measurement:

1. Invoke the Measure Function on an M-mode strip. A caliper measurement is automatically

invoked. It displays the Depth at the current location.

2. Move the Caliper to the desired location.

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3. Press the Set key to place that caliper and add the second half of the caliper pair. Further

presses of the Set key toggle which side of the caliper can be moved. Pressing the Enter key completes the caliper and allows you to create another tool

4. The Caliper measurement can display the following results:

 Distance

 Time

 Slope

HR：The HR measurement can provide the heart rate calculation by measured the time of the heart beat cycles.

To use the HR measurement：

1. Invoke the Measure Function on a Doppler strip.

2. If HR is not the default measurement, select HR from the touch screen.

3. Move the caliper to position the first heart beat. Press the Set key to activate a second

caliper.

4. Move the second caliper to position the next beat.

5. Press the Enter key to complete or press the Set key to switch moving the first caliper.

6. The HR measurement can display the following result(the actual results shown will

depend on the preset):

7.3.2. Application Measurements and Calculations

Application Measurements have a pre-defined meaning and can be entered into a report. Acclarix AX8 supports the following application packages, each with its own set of measurements, calculations and report:

 OB (including multiple fetuses)  Abd  Vascular  Cardiac  Gynecology  Small Parts  Urology  Pediatric(including Neonatal)

Please see the Advanced User Manual for the complete content of each package. When you select an application measurement from the touch screen it will automatically invoke

the type of measurement it needs. For example, if you select “BPD” from the OB application it will automatically invoke a distance measurement. These measurements generally behave as described above for generic measurements. However, a final press of the Enter key after the measurement is complete will enter the result into the report.

Some application measurements can have multiple variations. For example, in a twin OB exam the OB measurements can be done on either fetus. As another example, in Vascular exams several measurements can be done in a Proximal, Mid, or Distal location. When a measurement has

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multiple variations you will see buttons on the touch screen that let you pick which variation you are measuring.

7.3.2.1. Auto IMT

(Note: Auto-IMT is not available in the USA and some other countries.)

Intima-media thickness (IMT) is a measurement of the thickness of tunica intima and tunica media. The system provides an automatic measurement of the Carotid IMT.

Figure 7-6 IMT Touch Screen

To measure IMT:

1. Invoke the B-mode Measure Function in Carotid Preset.

2. Select an IMT measurement on the touch screen. A ROI box will be displayed on the

image field.

3. Select the buttons on right side of the touch screen to measure a different position of

carotid artery.

4. Press Set key to resize the ROI box, move the ROI box to locate the measure position.

5. Press Enter key to complete and get the Auto IMT measure results. Press Enter Key

again to save the results in the worksheet.

6. If you are not satisfied with the measurement result, press Undo key to restart the IMT

measurement.

7. The IMT measurement can display the following result:

 Max (the maximum value of the IMT results)  Min (the minimum value of the IMT results)  Avg (the average value of the IMT results)  Width (the width of the ROI box)  SD (the Standard Deviation of the IMT results)  Points (the number of valid points in the IMT results)

NOTE: IMT measurement can only be active in image frozen status.

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Figure 7-7 ROI Box of Auto IMT

Figure 7-8 Measure Result of Auto IMT

7.3.2.2. Simpson’s (Method of Disks)

Simpson is a tool in Cardiac presets used to determine LV diastolic and systolic volumes, and from that derive an ejection fraction.

To use the Simpson measurement:

1. Invoke the B-mode Measure function.

2. Select LV Simpson measurement on the touch screen and then select one measurement label

from A4C Dias., A4C Sys., A2C Dias., and A2C Sys.. A single caliper will be displayed on the image field.

3. Move the caliper and press Set key to position the start point A at one end of left ventricular

long axis.

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4. Draw the trace along the endocardium of left ventricular.

5. Press Set key to fix the end point B and complete the trace. A new caliper positions

automatically at the apex (Point D) of the trace, connecting the Point C (Midpoint of point A and B). This distance between point C and D is the longest detected by the system, as shown below:

6. Move the caliper(Point D) to a new desired position if necessary.

7. Press Enter key to complete the measurement.

See Chapter 6 Cardiac in advanced manual for the detailed Simpson measurement and calculation results and equations.

7.3.2.3. PISA

PISA (Proximal Isovelocity Surface Area) is a tool in Cardiac presets used for quantitative analysis of regurgitation. It is only available in Color and Doppler mode.

To use PISA measurement in Color mode:

1. Adjust the color image until the aliasing appears. Invoke the Measure function.

2. Select PISA measurement on the touch screen and then select a measurement label from MR

Rad, MR Als. Vel, AR Rad, AR Als. Vel, TR Rad, TR Als.Vel, PR Rad and PR Vls. Vel. A single caliper will be displayed on the image field.

3. Move the caliper and press Set key to position the caliper as the center of the semicircular.

4. Move the trackpad to adjust the radius length and orientation of the semicircular.

5. Press Enter key to fix the semicircular and then a dialog box of “Color Aliasing Velocity”

pops up.

6. Select “Top aliasing velocity”, “Bottom aliasing velocity”, or manually enter the aliasing

velocity from 0 cm/s to 500 cm/s.

7. Click OK and then measurement results are shown. To use PISA measurement in Doppler mode:

1. Freeze a strip image. Invoke the Measure function.

2. Select PISA measurement on the touch screen and then select a measurement label from MR

Trace, AR Trace, TR Trace and PR Trace.

3. Use the Doppler trace tool to get the measurement results. When all the measurements described above have been completed, the system automatically

calculates the Flow Rate, Flow and EROA(Effective Regurgitant Orifice Area). See Chapter 6 Cardiac in advanced manual for the detailed PISA measurement and calculation results and related equations.

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7.4 Patient Information Management

7.4.1. Storing Images

The control panel has three store keys: Store 1, Store 2, and Alt Store. Each store key can be separately configurable to support any of the following functions:

 Store a static image.  Store a clip.  Video print function

For details about the configuration of store keys, please refer to Section 8.

Storing an image:

1. If a Store key is configured to store a static image it will always capture what is on the

imaging area of the screen. This includes live, frozen, or Cine images. It also includes reports or other GUI screens and review.

Storing a clip:

1. If a Store key is configured to store a clip image it will capture the moving image in live or

auto cine play. If the image is frozen or a non-image screen is displayed then a static image is stored.

2. The store starts with the press of the button and continues for the configured length of the

clip or until the clip store is interrupted. The following events can cause the clip store to stop:

 A second press of the store button  Display of a GUI screen or dialog  Mode change  Reaching a pre-defined clip duration (refer to System Setup)  Image parameters change (depth and zoom in B/C mode, M cursor, sweep speed, strip

size and depth in M mode, angle, scale, baseline, invert, strip size and sweep speed in Strip Doppler mode.)

 Cine play pause (press Freeze button, Set button or dragging left along the Swipe button)

7.4.2. Reviewing Images

If Static or Clip images have been stored for the current exam then they can be reviewed by pressing the Review hard key on the console.

NOTE: If nothing has been stored in the current exam then the Review hard key will invoke the Patient Database function (see the next section).

Figure 7-9 shows an example touch screen for Review. The following table explains the action of each button in Review.

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Button

Description

Page

Change the display one page at a time.

Speed

Change the playing speed of the highlighted clip; the speed range is 12.5%-100%, in increments of 12.5%.The default speed is 50%.

L.Margin

Change the left margin of a highlighted clip

R.Margin

Change the right margin of a highlighted clip

Frame

Scroll the paused clip frame by frame

Play

Plays/Stops the highlighted clip. This can also be done with the Set key on the trackpad.

Overlay Display

Show or hide overlay icons on thumbnail images

Remove Deleted

Permanently remove all deleted images

Delete

Delete the highlighted image. A deleted image is marked by a deleted icon. To cancel the delete, press this button while the deleted image is highlighted

Change the displayed layout: 4*4, 2*2, 1*1, 2*3

Show Selected

Toggle between showing all images and only showing the selected images

Select

Toggle the highlighted image in/out of the selected images

Select All

Select all the images in the current exam.

Slideshow

Play all the images as a slideshow.

Export

Export selected images to a removable media currently available. Plug in a USB disk, select a image, press this button and the following confirmation dialog pop-up:

Figure 7-9 Review Screen

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Select the export path from destination drop list menu and click OK to confirm. If there is only one removable media then this field is a read-only field. Static images export as .bmp files. Clip images export as .avi files.

While export in progress the dialog is displayed as bellow. Cancel button is used to stop the export. The dialog disappears when export finishes.

If there is no USB plugged in, the message “The images cannot be exported because no USB flash drive is inserted” is displayed and no export work to do.

Exit

Exit review function

Table 7-3 Review Touch Screen Controls

Select Set: By default, Review displays all Static and Clip images stored for the current exam in the order

they were stored. Images can be placed into the Select Set by highlighting them and pressing the Select key on the touchscreen. Pressing the Show Selected button will then display the selected images in the order they were selected.

Reviewing Clips: By default stored clips playback at half speed. You can adjust the playback rate Review will show

Static and Clip images intermixed in the order they were stored.

Exiting Review:

In review state, press Review or B hard key on the control panel, or press the Exit button on the touch screen to exit the review function.

Measurement in Review State:

Measurements in review state are supported for the current exam (including restarted). Review a clip or static image for current active exam (please pause the clip when a desired image is got) and then press Measure hardkey on the console to start measurements.

Note:

1) PISA, Auto IMT and Auto Trace measurements are disabled in review state.

2) Measurements on stored panorama image are not available in review state.

7.4.3. Patient Database

The Patient Database provides a list of recently performed studies. It can be accessed by pressing the Review hard key on the console when there is no active exam. Figure 7-10 shows an example

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screen shot from the Patient Database screen.

Figure 7-10 Patient Database screen

The main part of the display shows a list of studies. Clicking on the header of a field will sort the list by that field. Fields can be displayed or hidden.

Filter: The database filter field at the top-left of the screen provides a powerful tool to find the study of

interest. It filters the list based on whatever text is typed in this field. The filter applies to all fields. For example, typing “Ab” into the filter will show exams that either have that text in either the patient name or in the Exam preset. By default the filter is set to blank, so the default list shows all exams.

Storage Size: There is a box displaying current disk usage. It contains text with the current usage and is filled with a solid color to the extent that the current capacity is used. The text shows

“<current usage> of <total capacity>”. The units are “Mb” for values less than 1 Gb, and “Gb”

for anything larger. The solid color fill is green when usage is less than 75% of capacity, yellow for usage between 75% and 95%, and red when disk usage is above 95%.

Destination: The location where the highlighted exam(s) shall be exported, including all configured network locations and any writable USB disk or DVD drive currently available. This includes:

 DICOM server location(s) defined in the DICOM section of Connectivity. (See 9.2.2)  FTP server location(s) defined in the Network Store section of Connectivity. (See 9.2.3)  Any inserted USB drive or DVD drive.

Remove DICOM Header: If this item is checked, static images will be exported as bmp format, and clips will be exported as avi format. Otherwise all the images will be exported as DICOM format. This interaction is only available when exporting to USB or DVD.

Send/Burn: Pressing this will send/burn the highlighted exam(s) to the destination. This button is available when one or more exams are selected.

Figure 7-11 Send database

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Working with one study:

A study is selected by clicking on it. When a study is selected thumbnail images from that study are shown on the right side of the screen.

A study can also be send to a DICOM server, saved to a USB device or DVD drive, or deleted. If the study has been copied to either a server or to a USB device or DVD drive a small disk icon appears next to it, indicating that it has been saved.

CAUTION:

 Studies stored on the system hard drive should be archived regularly. The system

is not intended for long term storage of patient information. Confirm successful archiving before deleting a study from the hard drive.

Working with multiple studies: Multiple studies can be selected by clicking the small box at the left of each listed study. Multiple

studies can be stored to a DICOM server, saved to a USB device or DVD drive, or deleted. Only one study can be reviewed at a time.

7.4.4. Archiving Studies

All Clips and Static images stored on the Acclarix AX8 are stored internally in DICOM format. They may be converted to .bmp and .avi as described below. The AX8 supports many methods to export an exam for long-term storage:

 The study can be sent to a DICOM server. In this case the images are in DICOM (.dcm)

format.

 The study can be send to an FTP server. In this case the images are in .bmp and .avi format.  The study can be saved to a USB or DVD. In this case the images can be stored as either

DICOM or .bmp/.avi format.

Sending a study to a DICOM server:

There are three ways to send a study to a DICOM server. See section 9 for details on configuring a DICOM server and choosing one of the following options

1. From the patient database screen, you can select a study or multi-studies and send it to a

configured server.

2. You can configure the system to automatically send the study at the end of the exam. With

this option the study is sent in the background while you continue to use the system for the next exam.

3. You can configure the system to automatically send each image and clip as it is stored. This

has the advantage that the images and clips are available on the server sooner. Note that if you have it configured this way you can still delete stored images and clips on the system, but that will not delete them on the server if they have already been sent.

Sending a study to FTP Server

Please see section 9 for details on configuring a FTP server. Once an FTP server is configured the exam can be sent to the server from the patient database screen. Select the exam(s) from the list shown, and select the FTP server from the list of currently configured destinations.

Saving a study to USB or DVD

If a USB flash drive or DVD is plugged in then studies can be archived to them in either DICOM or .avi/bmp format. Plug the device into a USB port prior to invoking the patient database

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screen, select the exam(s) from the list shown, and select the device from the list of currently configured destinations.

7.5 Needle Biopsy Guide

NOTE: Use proper sterile technique at all times when performing a biopsy.

Always follow these basic precautions:

WARNING

1. Disinfect the needle guide kit before the first use and after each subsequent use.

2. Calibrate the needle guide kit (see section 7.5.3) under any of the following

conditions:

a) The first time that each bracket/transducer combination is used. b) If the bracket or transducer head is dropped or struck, or has evidence of wear. c) If previous use has shown some drift of the needle from the center of the

guidelines.

3. The displayed needle guide pathway on the EDAN video monitor is intended for

reference during biopsy procedures. A variety of factors outside EDAN‟s control, such as changing tissue density, bending of the needle, off-axis pressure by the person holding the transducer, etc., may cause deflection of a needle outside of the displayed video pathway even when the transducer, needle guide, and the system software are all performing as intended and within manufacturing specification. The specialist performing a biopsy procedure must be aware of potential external factors when performing an invasive procedure.

4. Do not freeze the system when performing a biopsy.

5. EDAN needle guides are designed and manufactured to attach firmly to designated

transducers and should not require excessive force to assemble or disassemble. Do not use a needle guide that requires excessive force or manipulation to assemble or disassemble.

6. A single-use sheath should be used on transducer when performing a biopsy.

7.5.1. Installing Needle Guide Bracket

The needle guide bracket kit consists of the needle guide bracket and between 1 to 4 interchangeable guides for different gauge needles (see table 3-2 for details)

Step 1: Take the needle guide bracket kit out of the package. Check to make sure it is the correct kit for the transducer being used (see table 3-2) and inspect it carefully for any damage. See figure 7-12 for a typical needle guide bracket kit.

WARNING

The needle guide bracket kits are not disinfected or sterilized before delivery. Disinfect the needle guide kit before the first use and after each subsequent use For detailed operations, see 12.4.2 Needle Guide Bracket Cleaning and Sterilization.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Features

圆锥台

矩形卡槽

旋钮2

螺钉

旋钮1

一字形凸起

凹槽

Knob 1

Rectangular slot

Knob 2

Cone

Screw

Convex

Notch

Figure 7-12 Structure of Needle Guide Bracket Kit

Step 2: Select the correct size guide for the gauge of needle to be used, and secure it to the needle guide holder by tightening knob 1. If the needle guide holder is loose tighten the screw with an allen wrench. Loosen knob 2 all the way prior to installing the bracket on the transducer.

Step 3: The transducer has a small circular dimple on one side of the transducer, and a rectangular ridge on the other side. Place the needle guide bracket over the transducer such that knob 2 tightens into the circular dimple and the ridge sits inside the corresponding slot on the bracket. (see figures 7-13 through 7-16).

Figure 7-13 Convex slot of Probe Figure 7-14 Notch of Probe

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Acclarix AX8 Diagnostic Ultrasound System User Manual Features

矩形孔

Rectangular Hole

Figure 7-15 Attaching Bracket Kit to Probe Figure 7-16 Turning Knob 2 Clockwise

Step 4: Insert the needle into the rectangular hole, as shown in Figure 7-17.

Figure 7-17 Inserting Needle into Rectangular Hole

Installing needle guide bracket of endocavity probe:

Step 1: Take the needle guide bracket kit out of the package. Check to make sure it is the correct kit for the endocavity transducer (see table 3-2) and inspect it carefully for any damage. See figure 7-18 for an endocavity needle guide bracket kit.

WARNING

The needle guide bracket kits are not disinfected or sterilized before delivery. Disinfect the needle guide kit before the first use and after each subsequent use. For detailed operations, see 12.4.22 Needle Guide Bracket Cleaning and Sterilization.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Features

Lock

Knob 1

Fixing claws

Notches

Figure 7-18 Structure of Needle Guide Bracket Kit

Step 2: Attach the needle guide bracket kit to the transducer by placing the bracket over the head of the probe, ensure that the three fixing claws of the bracket catch in the notches at the probe tip, turn the lock clockwise as the arrow direction shown in Figure 7-21, and then turn knob 1 clockwise until it locks in place, as shown in Figure 7-22.

Figure 7-19 Notches at the Probe Tip

Figure 7-20 Turning the Lock Clockwise

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Acclarix AX8 Diagnostic Ultrasound System User Manual Features

Round hole

Figure 7-21 Turning the Knob 1 Clockwise

Step 3: Insert the needle into the round hole, as shown in Figure 7-22.

Figure 7-22 Insert the Needle into the Round Hole

7.5.2. Activating Needle Guide Function

To enable the needle guide function:

1. In the B mode imaging, press Needle button on touch screen, A needle touch screen UI is

displayed, Press Enable button to active the Needle Guide function.

2. Press Double Line button to switch double line and single line as the Needle guide Line

graphics.

3. Some needle guide brackets support multiple (up to 3) angles. If the current transducer

supports such a guide then the Angle button appears. Pressing it cycles through the available angles.

Figure 7-23 Needle Guide Touch Screen

NOTE: The distance between each dot of the needle guide line indicates 0.5 cm.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Features

7.5.3. To Adjust the Needle Guide Line

The needle guide bracket was calibrated during manufacture. However, certain events may cause the bracket alignment to shift, and new calibration required.

WARNING

1. Calibrate the needle guide under any of the following conditions:

a) The first time a needle guide is used with a given transducer. b) Any time the needle guide or transducer has been dropped or struck against a

hard surface.

c) After repeated use.

2. Do not use the needle guide bracket if the needle does not track with the guide during

calibration.

Figure 7-24 Needle Guide Calibration Touch Screen

To calibrate the guide line

1. Assemble the needle guide bracket on the transducer, and use the transducer to image a water

bath or needle guide phantom.

2. From the Needle function on the B-mode touch screen, press the Calibration button on the

touch screen to display the Angle and Position paddle button.

 Use the Position paddle to adjust the line horizontally until the origin aligns with the

actual needle.

 Use the Angle paddle to adjust the angle of the line until the entire line aligns with the

actual needle.

 Any changes will be saved as the default value automatically.

7.6 Needle Visualization

Needle Visualization is an image processing technology that enhances needle visibility. It is available in B-mode for all linear transducers.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Features

Angle Line

Figure 7-25 Needle Enhancement Visualization

Needle Visualization is invoked by pressing the Needle button on B-mode touch screen, and

then the Enable button in the Needle Visualization section of the Needle touch screen. The following parameters can be adjusted when it is active.

 Enable: Enables or disables Needle Visualization.  L/R: press to display the angle line on left side or right side of the image field.  Medium/Steep: press to enhance the needle visibility for different needle inserted angles:

24° (Medium) and 40° (Steep). For best results use the angle line that is closest to perpendicular to the needle path.

Figure 7-26 Touch Screen for Needle Enhancement Visualization

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

8 Presets

8.1 Preset Organization

The Acclarix AX8 Presets are divided into two levels: the Exam Presets and Application Presets. Exam Preset: Each transducer has its own set of Exam Presets. Each Exam Preset contains:

 The image parameters that optimize its transducer for an intended use.  The list of data fields displayed on the patient demographic page.  Pointers to Application Presets for Comments, Measurements, and BodyMarkers.

Application Preset: The Application Presets are independent from the transducer. Application Presets are used to select Comments, BodyMarkers and Measurements. Since they are independent from the transducer, several Exam Presets can use the same Application Preset.

Figure 8-1 shows an example of how Transducers, Exam Presets, and Application Presets are related. For simplicity, this shows just a few of the items that are on the real system. In this example the C5-2XQ and the E8-4Q both have an OB Exam Preset. The C5-2XQ OB Exam Preset optimizes the C5-2XQ imaging for OB while the E8-4Q OB Exam Preset optimizes the E8-4Q for the same use. The parameters used for each transducer can be different, and changing one Exam preset does not change the other.

However, both OB Exam Presets point to the same OB Measurement Preset as the Application Preset. This means you can, for example, just configure OB measurements once, and both the C5-2XQ and E8-4Q will have updated OB measurements.

This example just shows a single kind of Application Preset. The Acclarix AX8 actually has separate Application presets for Comments ,Bodymarkers and Measurements. The same principle applies to each of these: application presets can be shared across exam presets and transducers.

Figure 8-1 Preset Organization

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

8.2 Selecting a Preset

There are two ways to select a preset The Preset Function: The preset function is invoked by pressing the Preset button in the upper

left corner of the console. See figure 8-2 for an example preset touch screen. The currently active transducer is shown at the top of the touch screen. Below it are all the presets associated with that transducer. Pressing any preset button selects that preset, recalling its parameters for system use. If the system is configured with the optional Multi-Transducer Connector (MTC) this screen will show a top row of all connected transducers, allowing you to switch to any one of these and then select the preset to be used with that transducer.

Figure 8-2 Example Preset Screen

The Patient Page: An exam preset can also be selected from the patient page, typically at the beginning of an exam. A drop-down list of presets associated with the current transducer is shown near the top of the screen. Select from that drop down to change the preset. This will also change the demographic fields that are displayed.

8.3 Storing a Preset

There are two ways to store or modify an exam preset: Snapshot and Editing. Snapshot:

 Select the exam preset you want to modify or use as the basis for a new preset.  Make any changes you want to system settings using the standard imaging UI.  Press the Preset hard key on the console.  Press the Save button on the touch screen to update the current exam preset with the new

setting.

 Press the Save As button to create a new preset and rename the preset.

Editing:

You can directly view and change the settings for any preset using the Set-up function.

 Press the Utilities hard key on the console.  Press the Set-up button on the touch screen to invoke setup.

The screen shown in Figure 8-3 appears.

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

 Press System to edit overall system settings unrelated to presets. See section 9 for details.  Press Presets to do any of the following:

o Edit the imaging parameters of an exam preset. o Configure the demographic fields that appear for that preset o Configure which Comment, Measure, or Bodymarker presets are associated with

each exam preset.

 Press Comments to configure the pre-defined text of each comment preset.  Press Bodymarker to configure which bodymarker graphics appear with each

bodymarker preset.

 Press Measure to configure measurement options of each measure preset.

Figure 8-3 Top level Touch Screen for the Setup Function

8.3.1. Presets

Figure 8-4 shows an example of the presets page.

Figure 8-4 The Preset Definition Page

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

8.3.1.1. Editing Image Settings

Figure 8-5 shows an example imaging set-up screen for imaging parameters. This example shows the screen for editing the B-mode settings for the C5-2XQ Abdomen exam preset.

Figure 8-5: Example Set-up Screen for Imaging Parameters

Transducer and Exam Preset: There are drop-downs at the top of the screen for selecting the transducer and Exam Preset you want to edit. Each transducer has its own set of exam presets, and these two drop-downs let you select which exam preset, on which transducer, you want to edit.

Image Modes: The next row of controls show tabs for each imaging mode. These let you select which imaging mode you want to edit for the current exam preset. The example shows the B-mode tab selected.

The image mode is divided into two sections. Parameters that have one value for each preset are shown on the left. Parameters that are associated with Image Types are shown on the right.

Image Type: Each imaging mode has a set of image types. For example in B-mode the types are Detail, General, and Penetration. While imaging, the image type lets you quickly change the aesthetic look of the image without changing settings like depth or invert status. The right side of the preset set-up screen shows a tab for each image look. The parameters shown below those tabs let you customize that image type for the current preset.

8.3.1.2. Configuring Patient Info

Figure 8-6 shows an example of the Patient information configuration page. This page allows you to configure which demographic fields are shown for each exam preset.

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

Figure 8-6 Example Patient Information Configuration Page

To change the demographic fields shown with any preset:

 Select the preset you want to configure. This can either be done at the Preset Definition

level before invoking the Patient Information Configuration page, or it can be done directly on this page.

 Click the check box on any field you want to display.

8.3.1.3. Selecting Default Measurement Package

Measure: Select one of the pre-defined application measurement packages to be the default measure for the preset.

8.3.1.4. Selecting Default Comments Preset

Comments: Select one of the pre-defined comments presets to be the default comments for the preset.

8.3.1.5. Selecting Default Bodymark Preset

Bodymark: Select one of the pre-defined bodymark presets to be the default bodymark for the preset.

8.3.1.6. Selecting Default TI

TI: Select one of the pre-defined TI presets to be the default preset. TI here includes: TIS (Soft Tissue Thermal Index), TIB( Bone Thermal Index) and TIC (Cranial Bone Thermal Index)

8.3.1.7. Selecting Default Output Power

Output Power: Select one of the pre-defined acoustic output power.

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

8.3.2. Comments Presets

Figure 8-7 Comments Preset

Adding a new Comment：

1. Move the cursor to a blank field in the comments area and press Set.

2. Enter a new comment through keyboard and press Enter to finish editing.

Editing an Exist Comment in Comment Preset:

1. Move the cursor to a comment in the comments area and press Set.

2. Edit the selected comment through keyboard and press Enter to finish editing.

Deleting an Exist Comment in Comment Preset:

1. Move the cursor to a comment in the comments area and press Set.

2. Press Delete in touch screen to delete the selected comment.

Creating a Group of Comments:

1. Move the cursor over the intended comment then press-and-hold the Enter button. The

selected comment will pop-up.

2. Drag the selected comment on top of an adjacent comment or insert it into an adjacent

group, then Press Set. The selected comments are joined as one group.

Moving out a Comment from a Comment Group:

1. Move the cursor over the intended comment then press the Set button.

2. Press Delete button on touch screen. The selected comment is removed from the group.

The rest of the comments in the group will be re-ordered. If there is only one comment in the group, then the group is disbanded.

General Settings:

 Auto-erase comments when the image is unfrozen: If this option is enabled, the

comments will be erased when the image is unfrozen, otherwise the comments will only be erased on demand or at the start of a new exam.

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

 Suppress Comment on Unfreeze: If this option is enabled the Comment function goes

away when the system is unfrozen, and comes back again with the next freeze. Manually exiting the function causes it to remain inactive until manually activated.

Figure 8-8 Comment Setting

8.3.3. Bodymarker Presets

Figure 8-9 Bodymarker Preset Touch Screen

Enabling/Disabling a Bodymarker to a Preset:

Press a bodymarker on touch screen to switch it as checked or not, the bodymarker is enabled or disabled to current preset.

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

Pre-defined graphics area

Figure 8-10 Bodymarker Preset

Deleting a Bodymarker from a Preset:

If the selected bodymarker is from a user-defined which does not point to any exam preset, you can delete it with the Delete button.

If the selected bodymarker is from a user-defined which points to an exam preset, or the selected bodymarker is from a default preset, the Delete button will be unavailable.

1. Select a bodymarker from pre-defined graphics area.

2. Press Delete on the touch screen.

Moving a Bodymarker in Pre-Defined Graphics Area:

1. Move the cursor over a bodymarker in pre-defined graphics area and click Enter.

A green box displays outside of the bodymarker.

2. Move the trackpad to a desired position and click Enter. To move it to another page, move

the trackpad over page up or down icons.

Set a Default Bodymarker for a Preset:

Select a bodymarker from pre-defined graphics area and click Default, the bodymarker is set as a default bodymarker to select preset.

The default bodymarker can not be deleted from a preset until another bodymarker is selected as a default one.

General Settings:

 Auto-erase bodymarker when the image is unfrozen: If this option is enabled, the

bodymarkers will be erased when the image is unfrozen, otherwise the bodymarkers will only be erased on demand or at the start of a new exam.

 Suppress Body Mark on Unfreeze: If this option is enabled the bodymarkers function

goes away when the system is unfrozen, and comes back again with the next freeze. Manually exiting the function causes it to remain inactive until manually activated.

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

Pre-Defined Measurement Area

Figure 8-11 Bodymaker Preset

8.3.4. Measure Presets

The Preset UI of the Measure Presets set-up page is divided into the main screen display and the touchscreen display.

The main screen display shows the current measure presets. The list of presets is shown along the left side, and the grid of buttons to the right show the current content of the selected preset.

The touch screen display shows a library of all possible measurements that can be added to or deleted from any measure preset. The column along the left shows different clinical application types and the grid of buttons to the right show all the supported content for that application. You can add a measurement from any application to any preset.

Figure 8-12 Measure Preset

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

Adding a new Measure Preset：

A new measure preset can be added by copying an existing preset. The new measure preset contains the same measurements as the copied preset. Select a preset from the list along the left, and then press the Copy As button.

Enabling/Disabling a measurement in a Preset

Select the preset you want to configure from the list along the left side of the main screen. The current contents show in the grid along the right of the main screen. Press a measurement from the measurement library on the touch screen to toggle it in or out of the selected preset.

Figure 8-13 Measure Preset touch screen

Editing an Existing Measurement in a Measure Preset

1. Select the preset you want to customize from the list along the left of the main screen.

2. Select the measurement you want to customize from the grid along the right of the main

screen.

3. Press the Option button on the touch screen to customize the selected measurement.

4. If the selected measurement can be performed by different tools (Caliper, Trace, etc.) select

the tool you want from the tabs provided, and check the default box.

5. Check the boxes for the results that you want to derive from this measurement. For a Generic measurement, press Default button on the touch screen to configure it as a default

measurement for the current selected image mode in a preset.

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Acclarix AX8 Diagnostic Ultrasound System User Manual System Setup

Figure 8-14 Measurement Option

8.3.4.1. General Settings

Figure 8-15 Measurement General Settings

 Report Logo

The system supports a user-defined report header by importing a logo and setting the logo‟s position and size.

Report logo settings are as follows:

 Import: import a bmp format logo from USB disk.  Delete: delete the imported logo.

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EDAN INSTRUMENTS AX8EDAN User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual