EDAN INSTRUMENTS AX3EDAN User Manual

About This Manual

P/N:01.54.458117 MPN: 01.54.458117011 Release Date: March, 2019 © Copyright EDAN INSTRUMENTS, INC. 2018-2019

This User Manual applies to 1.0X releases for Acclarix AX3 series Diagnostic Ultrasound Systems including Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15 and Acclarix AX18. See Appendix A.9 for the difference between these models.

This User Manual Basic Volume together with the User Manual Advanced Volume (P/N:01.54.458118) contain necessary and sufficient information to use the Acclarix AX3 series Diagnostic Ultrasound Systems safely for the intended purposes and approved clinical applications.

Please read and make sure you understand all of the instructions in this manual prior to using the system. Disregarding instructions, particularly warnings and cautions, is considered abnormal use.

Not all measurements and features are available for all system models and configurations. This manual is based on the complete set of transducers and features available. Therefore, some of the contents may not apply to your product. If you have any questions, please contact your local EDAN representative. The pictures and interfaces in this manual are for reference only.

Conventions

In this manual, the following conventions are used to describe the system for better understanding:

 Bold: bold texts indicate keys or items on main screen or touch screen.  <Bold>: bold texts in angular brackets indicate buttons, knobs and other controls on the console

or on the keyboard.

 ->: Arrow indicates operations following the path.

Contact Information

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

Contents

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

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

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

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

2 Safety ............................................................................................................................................ 2

2.1 Warnings .................................................................................................................................... 2

2.2 Cautions ................................................................................................ ..................................... 4

2.3 Labeling Symbols ....................................................................................................................... 7

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

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

3.2 System Overview ..................................................................................................................... 12

3.2.1. Main Unit .......................................................................................................................... 12

3.2.2. Control Panel .................................................................................................................... 15

3.2.3. Screen Layout ................................ ................................................................ .................. 18

3.2.4. Touch Screen ................................................................................................................... 21

3.2.5. Trackball ........................................................................................................................... 22

3.3 System Preparation .................................................................................................................. 23

3.3.1. Battery Use ....................................................................................................................... 23

3.3.2. AC Power Use .................................................................................................................. 24

3.3.3. Transducer Connection .................................................................................................... 25

3.3.4. Powering on/ off ............................................................................................................... 27

4 Exam Operation ......................................................................................................................... 28

4.1 How to Start an Exam ............................................................................................................... 28

4.2 How to End an Exam ................................................................................................................ 29

4.3 How to Restart an Exam ........................................................................................................... 29

4.4 The Patient Information Page ................................................................................................... 29

4.5 Modality Worklist ...................................................................................................................... 32

5 Imaging ....................................................................................................................................... 33

5.1 B-mode ..................................................................................................................................... 33

5.1.1. Using B-mode ................................................................................................................... 33

5.1.2. B-mode Image Optimization ............................................................................................. 33

5.2 Color Mode ............................................................................................................................... 36

5.2.1. Color Mode Variants ......................................................................................................... 36

5.2.2. Using Color Mode ............................................................................................................. 36

5.2.3. Color Image Optimization ................................................................................................. 36

5.3 PW Mode .................................................................................................................................. 39

5.3.1. Using PW Mode ............................................................................................................... 39

5.3.2. PW Image Optimization .................................................................................................... 39

5.3.3. HPRF ............................................................................................................................... 42

5.4 CW Mode ................................................................................................................................. 42

5.4.1. Using CW Mode ............................................................................................................... 42

5.4.2. CW Image Optimization.................................................................................................... 43

5.5 M-mode ................................................................................................ .................................... 45

5.5.1. Using M-mode .................................................................................................................. 45

5.5.2. M-mode Image Optimization ............................................................................................ 45

6 Transducers and Biopsy ........................................................................................................... 47

6.1 Transducers .............................................................................................................................. 47

6.2 Using Transducers.................................................................................................................... 48

6.3 Transducer Cleaning and Disinfecting ...................................................................................... 51

6.3.1. Cleaning ........................................................................................................................... 51

6.3.2. Disinfecting ....................................................................................................................... 51

6.4 Needle Biopsy Guide ................................................................................................................ 54

6.4.1. Installing Needle Guide Bracket ....................................................................................... 54

6.4.2. Activating Needle Guide Function .................................................................................... 58

6.4.3. Calibrating the Needle Guide Line .................................................................................... 59

6.5 Needle Visualization ................................................................................................................. 60

6.6 Center Line ............................................................................................................................... 61

6.7 Needle Guide Bracket Cleaning and Sterilization ..................................................................... 61

7 Features ...................................................................................................................................... 62

7.1 Comment .................................................................................................................................. 62

7.2 Body Mark ................................................................................................................................ 64

7.3 Dual Image Display .................................................................................................................. 65

7.4 Zoom ........................................................................................................................................ 65

7.5 Cine Review ............................................................................................................................. 66

8 Measurements and Reports ...................................................................................................... 67

8.1 Generic Measurements ............................................................................................................ 68

8.1.1. B-mode Generic Measurements ....................................................................................... 68

8.1.2. Strip Doppler Generic Measurements .............................................................................. 71

8.1.3. M-mode Generic Measurements ...................................................................................... 75

8.2 Application Measurements ....................................................................................................... 76

8.2.1. Abdomen Measurements.................................................................................................. 77

8.2.2. Gynecology Measurements .............................................................................................. 78

8.2.3. Obstetrics Measurements................................................................................................. 79

8.2.4. Cardiac Measurements .................................................................................................... 81

8.2.5. Small Parts Measurements .............................................................................................. 84

8.2.6. Urology Measurements .................................................................................................... 84

8.2.7. Vascular Measurements ................................................................................................... 85

8.3 Worksheet and Report .............................................................................................................. 88

8.3.1. Worksheet ........................................................................................................................ 88

III

8.3.2. OB Worksheet .................................................................................................................. 90

8.3.3. Growth Curve ................................ ................................................................ ................... 91

8.3.4. Report .............................................................................................................................. 93

8.4 Measurement Accuracy ............................................................................................................ 95

9 Exam Data Management ................................................................................................ ............ 96

9.1 Storing Images ......................................................................................................................... 96

9.2 Reviewing Images .................................................................................................................... 97

9.3 Exam Database ........................................................................................................................ 99

9.4 Archiving Studies .................................................................................................................... 100

10 Presets ...................................................................................................................................... 101

10.1 Preset Organization .............................................................................................................. 101

10.2 Selecting a Preset ................................................................................................................ 102

10.3 Storing and Editing a Preset ................................................................................................. 102

10.3.1. Exam Preset ................................................................................................................. 103

10.3.2. Image Preset ................................................................................................................ 104

10.3.3. Comment Preset .......................................................................................................... 105

10.3.4. Body Mark Preset ......................................................................................................... 106

10.3.5. Measure Preset ............................................................................................................ 107

11 Utilities ...................................................................................................................................... 109

11.1 System Set-up ...................................................................................................................... 109

11.1.1. General Set-up ............................................................................................................. 109

11.1.2. Patient Set-up ............................................................................................................... 111

11.1.3. Store/Print Set-up ......................................................................................................... 112

11.1.4. Report Set-up ............................................................................................................... 113

11.1.5. Image Set-up ................................................................................................................ 114

11.2 Connectivity .......................................................................................................................... 115

11.2.1. TCP/IP .......................................................................................................................... 115

11.2.2. DICOM .......................................................................................................................... 116

11.3 Maintenance ......................................................................................................................... 118

11.3.1. License ................................................................................................ ......................... 118

11.3.2. Version .......................................................................................................................... 119

11.3.3. Demo ............................................................................................................................ 119

11.3.4. Tool ............................................................................................................................... 120

11.4 Screen Adjust........................................................................................................................ 120

12 In Between Exams ................................................................................................................... 122

12.1 Unpacking ............................................................................................................................ 122

12.2 Transport .............................................................................................................................. 122

12.3 Storage ................................................................................................................................. 122

13 Troubleshooting and Maintenance ......................................................................................... 123

13.1 Daily Checklist ...................................................................................................................... 123

13.2 Troubleshooting .................................................................................................................... 123

13.3 Cleaning the System ............................................................................................................ 124

13.4 Maintenance ......................................................................................................................... 126

Appendix A Specifications ......................................................................................................... 127

A.1 Electrical Safety Classifications ........................................................................................... 127

A.2 Power Supply ...................................................................................................................... 127

A.3 Machine Specifications ........................................................................................................ 128

A.4 Display Specifications ......................................................................................................... 128

A.5 General Specifications ........................................................................................................ 128

A.6 Wi-Fi Specifications ............................................................................................................. 129

A.7 Operating, Storage and Transportation Environment .......................................................... 129

A.7.1 Operating Environment ................................................................................................ 129

A.7.2 Storage and Transportation Environment .................................................................... 129

A.8 Transducer Specifications ................................................................................................... 130

A.9 Configuration Difference ...................................................................................................... 130

Appendix B Ultrasound Intensity and Safety ........................................................................... 131

B.1 Ultrasound in Medicine ........................................................................................................ 131

B.2 Ultrasound Safety and the ALARA Principle ........................................................................ 131

B.3 Explanation of MI/TI ............................................................................................................ 132

B.3.1 MI (Mechanical Index) ................................................................................................. 132

B.3.2 TI (Thermal Index) ....................................................................................................... 132

B.3.3 Display of MI/TI ............................................................................................................ 133

B.4 Acoustic Output ................................................................................................................... 133

B.4.1 Factors that Contribute to Uncertainty in the Output Display ....................................... 133

B.4.2 Differences between Actual and Displayed MI/TI ......................................................... 133

B.4.3 Measurement Uncertainty ............................................................................................ 133

B.4.4 Acoustic Power Default Settings .................................................................................. 134

B.5 Operator Control Features ................................................................................................... 134

B.6 Prudent Use Statement ....................................................................................................... 135

B.7 References for Acoustic Output and Safety ......................................................................... 135

B.8 Transducer Acoustic Output Data ........................................................................................ 135

Appendix C Order List ................................................................................................................ 136

Appendix D EMC Information .................................................................................................... 138

Acclarix AX3 Series Diagnostic Ultrasound System User Manual Introduction

1 Introduction

1.1 Intended Use/ Indications for Use

The Acclarix AX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics. General clinical applications include:

 Abdominal  Gynecology (including endovaginal)  Obstetric  Cardiac  Small Parts (Breast, Testes, Thyroid, etc.)  Urology  Musculoskeletal  Peripheral Vascular  Adult Cephalic

1.2 Contra-indications

The Acclarix AX3 series Diagnostic Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

1.3 Device Description

The Acclarix AX3 series Diagnostic Ultrasound System consists of a main system and associated ultrasound transducers.

The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezoelectric 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 then converts the waves back to an electrical signal. The system then analyzes the returned signals and generates an ultrasound image or spectral Doppler display.

The Diagnostic Ultrasound System provides 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‟s user interface provides both hard keys for functions frequently used throughout an exam and touch screen controls for mode-specific functions.

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Acclarix AX3 Series 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 system. For your convenience, all warnings and cautions are provided in this section, but may be duplicated elsewhere in this document in the context of the instructions for use.

2.1 Warnings

 Only use Edan supplied power adapter and power cord.  Only use 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). The transducers

(not including transducer connector) is IPX7 certified. The footswitch is IP68 certified. Do not immerse or expose any of the parts to extended moisture. Splash resistance does not extend to transducer connectors. Please 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 the 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.

 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.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety

 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

become hot, ignited or possibly explode, and it may lead to decreased battery capacity. It is necessary to read the user manual instructions and warning messages carefully.

 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 during an exam.  Install the system according the EMC guidance provided in Appendix D.  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 Appendix D 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 it from the power supply.

 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 Service Manual, available from your Edan representative.

 Keep non-medical equipment 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 system grounding and

cause the system to exceed current leakage limits.

 It is not suggested to use a multiple socket-outlet with the device. If one is required, make sure

that the multi-socket complies with the requirement specified in Chapter 16 of IEC 60601-1, or the multi-socket is with an isolation transformer. And the multi-socket shall not be placed on the floor.

 SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied as a part

of the system, to the multiple portable socket-outlet supplying the system.

 SHOCK HAZARD - Don't connect non-electrical equipment, which has been supplied as a part

of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer.

 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 comply 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.  The system may be interfered with by other equipment, even if that other equipment complies

with CISPR EMISSION requirements.

 The system cannot be used together with high-frequency surgical equipment.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety

 Remove the battery from the device when the device is not used for a long time.

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 procedure. Use a new sterile sheath for each

such procedure.

 Unplug the transducer from the system prior to cleaning or disinfecting.  Do not immerse the transducer beyond the point indicated in Figure 6-3.  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 other than the battery cover.

 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 from one battery to

come in contact with other batteries. Batteries (including button cell on the main board) are hazardous waste. 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. Inappropriate disposal of waste may contaminate the environment.

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

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 malfunctions.

 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.

Appendix B.2 Ultrasound Safety and the ALARA Principle

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety

 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 source before

cleaning and disinfecting.

 No user serviceable parts are inside the system. All repairs on the system must be performed

by EDAN certified service personnel.

 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.

 The packaging is to be disposed of according to local or hospital‟s regulations; otherwise, it

may cause environmental contamination. Place the packaging at a location that is inaccessible to children.

 Patient data transmitted by the system is not encrypted. Please ensure the physical security of

the network. If WiFi is used, use WPA2 protocol and require a WiFi password.

 Only use upgrade files with known provenance. Confirm that the system boots to imaging after

an upgrade.

 Properly dispose of used cleaning agents or disinfectants according to your hospital's

regulations.  The system does not need calibration as part of routine maintenance. 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 store the transducer in

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 AX3 Series Diagnostic Ultrasound System User Manual Safety

Federal Communications Commission (FCC) statement:

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.

The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction.

Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety

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

CE Marking

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.

IPX7

No harm for short time immersion

2.3 Labeling Symbols

The following labels are used on the system:

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety

Type BF Applied Part

Transducer connector

Pencil Transducer connector (reserved)

Transducer lock

Transducer unlock

Network port

Trademark

Direct current

S-Video Output port

USB 2.0 port

USB 3.0 port

HDMI

HDMI port

AC Power Indicator

System Working Indicator

Battery Indicator

Non-ionizing electromagnetic radiation

FCC ID: SMQAX3EDAN

Federal Communications Commission: FCC ID:SMQAX3EDAN

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety

No.

Symbol

Definition

This way up

Fragile

Keep away from rain

General Symbol for Recovery / Recyclable

Stacking limit by number

Do not step on!

Handle with care

The following labels are used on the packaging:

NOTE:

The user manual is printed in black and white.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

Model

Angle/Depth

Description

BGK-C5-2

20° , 28°, 40°

For use with the C5-2Q, Supports: 14G-23G

BGK-L40UB

34°, 43°, 53°, 66°

For use with the L17-7Q, Supports: 14G-23G

BGK-001

1.0cm, 1.5cm, 2.0cm

For use with the L17-7Q, Supports: 21G

BGK-002

38° , 46°, 58°

For use with the L12-5Q, Supports: 14G-23G

BGK-003

1.0cm, 1.5cm, 2.0cm

For use with the L12-5Q, Supports: 21G

BGK-CR10UA

2°

For use with the E8-4Q, Supports: 16G, 18G

3 Getting Started

3.1 System Configuration

Standard Configuration:

The system is shipped with the following components:

 1 main unit  1 AC adapter  1 power cord  1 rechargeable lithium battery  1 USB disk  1 bottle of coupling gel  1 basic user manual and 1 advanced user manual  1 packing list

Options:

The following options are also available:

 Transducers:

C5-2Q, L12-5Q, E8-4Q, P5-1Q, L17-7Q

 Needle Guide Bracket Kit

 2nd rechargeable lithium battery  Footswitch  Suitcase

Table 3-1 Needle Guide Bracket Kits

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

Printer Type

Printer Model

Interface

Color Video Printer SONY UP-25MD

S-Video

SONY UP-D25MD

USB

B/W Video Printer

SONY UP-X898MD

USB

Report Printer

HP Officejet Pro 251dw

USB

HP LaserJet Pro 200 color M251n

USB

HP LaserJet CP1525n Color

USB

HP Deskjet Ink Advantage 2010

USB

HP Deskjet 1010

USB

HP Deskjet 1510

USB

HP LaserJet 400 M401d

USB

HP DeskJet Ink Advantage Ultra 2029

USB

HP DeskJet 1112

USB

Canon E518

USB

Canon iP2780

USB

HP LaserJet Pro MFP M126nw

USB

EPSON L310

USB

HP DeskJet 1050

USB

HP DeskJet 2050

USB

HP LaserJet M252n

USB

EPSON L130

USB

Supported Peripheral Accesories：

 The recommended printers are listed as follows:

Only the recommended printers listed above are verified by EDAN. Therefore, it is suggested to only use these printers. Use of other printers should comply with IEC 60950 or IEC 60601-1. Edan is not responsible for the accuracy of other printers.

Table 3-2 Printer List

WARNING

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

6 7 6 7 8

11 9 10

3.2 System Overview

3.2.1. Main Unit

Figure 3-1 Main Unit

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

No.

Name

Description

Monitor

Display the images and parameters during scanning.

Power Switch

Power on/off the system.

Touch Screen

Use to control operation and activate functions.

Control Panel

Use to control the operation .

AC Power Indicator

It illuminates when the system is connected to AC power.

It is off when the system is no connected to AC power

System Working Indicator

It illuminates when system is running, and it is off when the system is shutdown.

Battery Indicator

It is off when no battery is connected or battery is fully charged.

It illuminates in orange when battery is low. It illuminates in green when the system

operates on battery power or the battery is charging.

Transducer Locking Lever

Use to lock or unlock the transducer.

Transducer Port

Used for connecting a transducer to the system.

Handle

Used for carrying the system.

Safety Lock Connector

Used for connecting a safety lock to the system.

Vents

Used for heat dissipation and ventilation.

I/O Ports

Use to connect the I/O extend modules.

1. Ensure system vents are clear and unobstructed. Bad ventilation will result in high system temperature. When the high temperature warning "System Temperature is High. Please check the system for good ventilation" displays, refer to section 13.2 Troubleshooting for the specific troubleshooting steps.

2. Excessive dust and dirt could clog internal airflow and cause overheating. Do not use in a dusty environment.

Table 3-3 Main Unit Description

CAUTION

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

Power supply

Network port

S-Video output port

HDMI port

USB 3.0 port

USB 2.0 port

1 2 3 4 5 6 7

I/O Ports on the left panel:

Figure 3-2 I/O ports

Table 3-4 I/O Ports

Caution

1. The HDMI port does not support "hot plug" feature. Please connect the external display to the HDMI port before starting the ultrasound system. Otherwise the external display may be unrecognized or display abnormally.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

No.

Key

Name

Description

Power switch

Press to power on/off the system

Patient

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

Transducer

Press to switch transducers or exam presets.

Review

Press to enter exam database or image review mode. See section 9 for details.

Press to print images via the connected video printer.

3.2.2. Control Panel

Figure 3-3 Control Panel

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

Report

Press to display the report page.

User-defined button

Clear

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

10.

Body Mark

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

11.

Cursor

Press to hide or display the mouse cursor.

12.

Press to return to B-mode imaging from any other imaging modes. See section 5.1 for details.

13.

Color

Press to enter or exit Color Mode. See section 5.2 for details.

14.

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

15.

Press to get the sample line. Use the trackball to adjust the position of the sample line. Press it again to display the Doppler strip.

See section 5.3 for details.

16.

Press to get the sample line. Use the trackball to adjust the position of the sample line. Press it again to display the Doppler strip.

See section 5.4 for details.

17.

Comment

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

18.

Measure

Invokes the Measure function for Generic and Application Measurements. See section 8 for details.

19.

Single

Press to display the currently active side of Dual image as a single image. See section 7.3 for details.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

20.

Dual

Enters dual split screen. Each single press on it toggles between two images. See section 7.3 for details.

21.

Store Image

Press to store static images.

22.

Store Clip

Press to store clips.

23.

Freeze

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

24.

Update

In measurement, pressing <Update> switches the active side of calipers. See section 8 for details.

When Spectral Doppler strip is displayed, pressing <Update> allows switching between live acquisition of the Doppler strip or the reference image.

25.

Trackball

Move the trackball to change the cursor position, adjust M mark position in M mode, adjust sample line position in PW mode, etc.

26.

Trackball keys

Two trackball keys provide a wide variety of functions depending on the system state (e.g., selects a start or end point of a measurement, selects menu items on the screen, etc). For the convenience of introduction, we call them <Set> throughout this user manual.

27.

Zoom/Angle

The functions of this knob vary with system functions. When one function is activated, its indicator illuminates. Then rotate to zoom an image or adjust the angle.

For example: In B and Color mode, the Zoom function is auto activated

and its indicator illuminates. Rotating the knob will zoom images.

In PW or CW mode, the Angle function is auto activated and its indicator illuminates. Rotating the knob will adjust the Doppler scale to account for the angle between the Doppler cursor and the blood flow.

When Comment or Body Mark function is enabled, the Angle function is auto activated and its indicator illuminates. Rotating the knob will adjust the angle of comment arrow or the transducer icon.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

28.

Depth

Rotate to adjust the depth of the image displayed.

29.

Auto/Gain

Press to optimize B image automatically. Rotate to change the gain of images.

①

④

⑤

②

③ ⑤ ⑥

Table 3-5 Buttons on Control Panel

3.2.3. Screen Layout

Figure 3-4 Main Screen Display

① Information Field

The top line of this field contains your hospital/institution name. Please see Section

Set-up

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:

for information on customization.

 The currently active transducer  The currently active preset  System 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 depth, TGC, maps, image parameters, MI and TI.

11.1.1 General

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

No.

Shortcut Keys

Description

1 Select All

Selects all the displayed static images and clips.

2 Delete

Deletes the selected static images and clips.

3 Export

Exports the selected static images and clips to removable storage devices.

4 Page Up

Turns the page up when more than one page of images are displayed.

5 Page Down

Turns the page down when more than one page of images are displayed.

No.

Icons

Description

Utility icon

Provides access to system setup, screen adjust, connectivity, maintenance, etc.

Image Store icon

Displays the number of static images and clips stored in the current exam.

USB icon

USB disk available.

Printer icon

Printer available. Symbol is in green when printing in progress.

③Mini Report The left side of the screen displays a “mini-report” which displays measurements performed during the

current exam. ④Thumbnail Field The right side of the screen displays thumbnail images of all statics and clips captured for currently

active exam or when in Review. This field also contains several shortcut keys for selecting, viewing, deleting, exporting images. See the below for details:

⑤ Soft Keys Field

The soft keys filed is displayed below image field and above status bar. This field displays:

 The illustration of trackball and trackball keys.  Cine bar when the system is frozen.

 An "Exit" icon . Only displayed in review mode. Clicking on this icon will exit the review

mode.

⑥ Status Bar

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

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

Wi-Fi icon

Wi-Fi function is enabled, but no WI-FI network is connected.

No WI-FI icon will be displayed when Wi-Fi function is disabled in Connectivity setup.

Wi-Fi network is connected. Clicking on this icon shows a list of available Wi-Fi networks.

Selecting an available network displays a dialog box for entering password. Clicking on the "WiFi: Turn off" button above the list will disconnect the currently connected WI-FI network.

WI-FI network is disconnected. Clicking on this icon shows a "WiFi: Turn on" button.

Clicking on this button shows a list of available Wi-Fi networks. Selecting an available network displays a dialog box for entering password.

Network Transfer Status icon

The network transfer status icon shows the transfer statuses of the DICOM network.

 Outline in grey color: At least one DICOM network is

configured for file transfer.

 Outline in green color: Data exchange with a DICOM

Server.

 Outline in red color: No DICOM network is configured

for file transfer.

Clicking on this icon displays a queue of exam or image transfers and as well as the transfer status of each exam or image including refused, pending, active, succeeded and failed.

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.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

Battery icon

Battery fully charged, symbol in green.

Battery more than 80% charged.

Battery 60%-80% charged.

Battery 40%-60% charged.

Battery low, symbol in red.

Battery removed.

Battery charging.

3.2.4. Touch Screen

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

Figure 3-5 Touch screen of the System

A. Tabs: Each imaging mode that is active has a tab at the top of the touch screen. Usually, the

imaging mode that was most recently activated is the top tab and has priority. Pressing on any other tab will bring it to the top and provide access to the controls available for that imaging mode.

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

Pressing anywhere on the control and swiping across it will continuously change the value. C. Push button: This can either be an on/off control (like “Colorize”). D. Radio Buttons: A collection of buttons where only one is active at any time. Activating one will

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

de-activate all others. E. 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. F. 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.

3.2.5. Trackball

The trackball operation is easy and convenient. It can achieve the following functions:

 Move the measurement cursor during measurement.  Move the comment cursor in the comment status.  Move the M Mark in the B+M mode.  Move the scan area of Color mode, increase or decrease the size of scan area of Color mode.  Move the sample line in the PW/CW mode.  Realize single frame playback in the frame-by-frame playback status.  Move the zoomed window in the zoom status.

NOTE:

1. Please be gentle when running the trackball.

2. Please keep the surface of trackball clean.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

3.3 System Preparation

3.3.1. Battery Use

The system may come with two lithium-ion batteries depending on your order. One fully charged battery can run the system for approximately 1 hour and two fully charged batteries together can run the system for approximately 2 hours, depending on use. The batteries are automatically charged when the system is plugged in.

The system has two battery compartments which are identified by letter A and B respectively. The battery icon of the battery which is installed in battery compartment A is displayed with letter A on it and the battery icon of the battery which is installed in battery compartment B is displayed with letter B on it.

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 6 months to ensure battery capacity is more than 75%.

3. Only use Edan supplied battery.

To install the battery:

1. Turn off and unplug the system.

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

3. Unscrew the three screws securing the battery door, and remove the battery door.

Figure 3-6 Removing battery door.

4. Put the battery gently to battery compartment.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

Figure 3-7 Installation of the Battery

5. Close the battery door and screw the three screws.

To remove a battery:

1. Turn off and unplug the system.

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

3. Unscrew the three screws securing the battery door, and remove the battery door.

4. Remove the battery.

5. Close the battery door and screw the three screws.

WARNING

1. When the battery capacity is ≤20%, the battery status icon turns red.

2. When the battery capacity is ≤10%, the system displays a prompt “Low Battery. The

system will shutdown in 3 mins. Please plug in the power supply immediately."

3.3.2. AC Power Use

When using AC power, position the system so that it is easy to disconnect it from AC power supply. To connect AC power:

1. Connect the AC power cord with the power adapter.

2. Connect the DC power cord from the power adapter to the power connector on the system. Make

sure the side with a "Direction Indicating Dot" should face upside when connecting the DC power connector, as the illustration below.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

Direction Indicating Dot

3. Push the power cord in firmly to ensure a secure connection.

4. Connect the AC power cord to a hospital-grade power outlet.

WARNING

1. Make sure the AC power supply complies with the following specifications: 100V-240V~, 50Hz/60Hz.

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

3. Only use Edan supplied power adapter and power cord.

3.3.3. Transducer Connection

To connect a transducer:

Figure 3-8 Tansducer Locking Handle

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

2. Toggle the locking handle to the top position.

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

irreparable damage.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

Figure 3-9 Lock the tansducer locking handle

To disconnect a transducer:

1. Toggle the locking handle to the bottom position to unlock the transducer connector.

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.

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.

3. Only disconnect a transducer when the system is shutdown or is frozen.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Getting Started

3.3.4. Powering on/ off

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 the control panel.

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:

1. Turn off and unplug the device after use.

2. 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 power. There are three events that can invoke sleep mode:

 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

There are two events that can exit sleep mode:

 Open the cover of the system.  Press the Power on/off key.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation

4 Exam Operation

4.1 How to Start an Exam

1. Press the <Patient> key and enter patient information, or select a scheduled patient from the modality worklist.

If there is no previous exam, pressing the <Patient> key 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

The following options are available:

 End Exam: select this to end the current exam and return to live imaging to start a new

exam.

 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.

If Same Patient is checked, selecting New Exam will end the previous exam and create a new exam for the same patient. The main screen will display the Patient Information Page with the previously entered patient information except for the exam accession number. Changing the patient information for one exam will not impact the others. If Same Patient is unchecked, selecting New Exam, a blank Patient Information Page will be displayed for entering patient information for a new patient. Tick the check box of Same Patient when operating multiple exams for same patient.

 Cancel: Exits the dialog without starting or ending an exam.

2. Press OK on the touch screen or press the <Patient> key again to start scanning.

3. To change transducer or exam preset, press the <Transducer> key, and then the Transducer touch screen provides you choices of available transducers and exam presets, as the figure below.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation

Figure 4-2 Example of Transducer Touch Screen

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 New Exam. This both

ends the exam and displays the Patient Information Page for the next exam.

 Pressing the <Patient> key, as described above, and then selecting End Exam. 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.

4.3 How to Restart an Exam

1. Select an exam from the Exam Database within the time limit selected in Patient Set-up menu.

For the setting of time limit, refer to section

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.

11.1.2 Patient Set-up

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:

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation

Figure 4-3 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 date of birth is entered, the age is automatically calculated.

Note: By default, the patient name has two fields: family name and given name. It can be configured to be

one field in the Patient Setup screen (See section 11.1.2 for detail). The next line displays tabs of multiple exam presets, and the associated patient information fields are

displayed below this line. The patient information needed to fill in changes with different exam presets. All the possible patient information fields you may need to fill in are listed below:

 Gender: Select the patient‟s gender: “M” (Male), “F” (Female), “O” (Other), or “<blank>”.  LMP: Last Menstrual Period (yyyy/mm/dd or mm/dd/yyyy), 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 autocalculated 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 or mm/dd/yyyy).EDD is autocalculated 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 values for each

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.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation

 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.  Comment: Enter any additional comments.

While the Patient Information Page is displayed the following buttons are displayed on the touch screen and Patient Information Page:

Figure 4-4 Patient Information Touch Screen Press OK to exit the Patient information Page and save the patient information. 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.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Exam Operation

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 setup screen, the worklist is shown to the left of the Patient Information Page, as shown below.

Figure 4-5 Modality Worklist Display

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

The worklist shows all scheduled ultrasound exams within the date-range specified in the DICOM connectivity setup screen (See 11.2.2). Typing any text in the Filter field will filter the list to exams that contain the entered text.

Update: Press to query the patient data and update the list manually. Hide List: Press 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 entered into the associated fields

on the patient information page, with the option to edit or complete. Then press OK on the touch screen to start an exam.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

Name

Control

Description

TGC

The Time Gain Compensation 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 adjust all sliders to a new setting.

Dynamic Range

The Dynamic Range, or log compression, adjusts how echo intensities are converted to brightness. A high dynamic range will display more shades of gray, while a low dynamic range will display fewer shades of gray and a more contrasty image.

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 to reduce random noise. There are 4 options: Off, Low, Med., and High. The persistence level corresponds to the number of frames averaged. The frame rate is unchanged.

Frequency

Frequency allows selection of the fundamental or harmonic frequencies used for imaging. The Harmonic option must be invoked to access the harmonic frequencies. Frequency selection is available during live imaging.

5 Imaging

5.1 B-mode

5.1.1. Using B-mode

1. Press <B> on the console to enter B mode.

2. Perform the image scanning.

3. Adjust Image parameters to optimize the image.

5.1.2. B-mode Image Optimization

The following touch controls can be used to optimize the B-mode image.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

Harmonic

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

Spatial Compounding

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

Focus Number

Focus Number adjusts the number of foci is displayed. As the number of foci increases, image uniformity across depth will increase, but the frame rate will decrease.

Focus Position

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 postprocessing 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. There are 20 tint maps 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 and is used to toggle 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.

Up/Down

The Up/Down invert control is indicated by an upside-down R and is used to toggle the up/down orientation of the image. The TGC curve is also re-oriented with Invert On, so that the top of the TGC curve corresponds to the top of the image on the screen.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

FOV

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

Steer

The Steer control is only available for linear transducers and steers the B-mode image left or right, without moving the transducer. This function can be particularly useful when visualizing needles or other objects that are enhanced by a perpendicular beam. Steer is not available if Spatial Compounding or Trapezoid are turned on.

Trapezoid

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

Image Type

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

10.3.2

for more information.

Line Density

Adjusts the line density to optimize the lateral resolution for the best possible image. The higher the line density, the higher the lateral resolution, but the lower the frame rate.

Needle

Press to invoke the touch screen for Needle Enhancement Visualization and Needle Biopsy Guide functions. See section 6.4 and 6.5 for more information.

Acoustic power

Adjusts the acoustic output power of the activate transducer and is only available in live imaging. Higher acoustic power numbers correspond to increased sensitivity in the image with improved penetration, but the ALARA principle should be followed in actual clinical situations.

Center Line

Press to activate the Center Line function. Refer to section

6.6 for details.

Table 5-1 B-mode Touch Screen Controls

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

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 5.4.1 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.

5.2 Color Mode

5.2.1. Color Mode Variants

The 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 cannot 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.

5.2.2. Using Color Mode

1. Perform the image scanning to get a good image in B mode;

2. Press <Color> to enter B+Color mode and display ROI box;

3. Adjust the size and position of ROI box.

Presses on <Set> switch between the status of adjusting the size and position of ROI box. Use trackball to adjust.

4. Press PDI, DPDI or Color mode key on the touch screen to switch Color Doppler modes when

necessary;

5. Adjust image parameters to optimize the Color image.

5.2.3. Color Image Optimization

The following touch controls can be used to optimize the Color image.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

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

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

Wall Filter

The Filter control removes excessive noise from movement of vessel walls. Options of Low, Med. and High are available. Higher wall filter level will suppress more strong single of the vessel walls, but low flow signal will be missing.

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 color signals from a region within the Color ROI box, the Threshold determines whether to display overlapping signals as grayscale or color.

In Color mode, higher Threshold values display more color, and lower Threshold values display more grayscale.

Upward presses increase threshold. Downward presses decrease threshold.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

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.

Dynamic Range

The Dynamic Range, or log compression, adjusts how echo intensities are converted to brightness. A high dynamic range presents a flatter, less contrasty color display, while a low dynamic range presents a more contrasty color display. Only available in PDI/DPDI mode.

Line Density

Adjusts the line density to optimize the lateral resolution for the best possible image. The higher the line density, the higher the lateral resolution, but the lower the frame rate.

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Acclarix AX3 Series 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 increased color sensitivity and penetration, but the ALARA principle should be followed in actual clinical situations.

Name

Control

Description

Scale

Scale adjusts the range of velocities that are displayed. Upward presses increase scale and downward presses decrease scale. Increasing scale when the PW cursor is relatively deep may result in invoking HPRF, if it is configured. See section 5.3.3 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, the negative velocities are displayed above the baseline. Invert does not affect the baseline position.

Quick-Angle

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

Table 5-2 Color Mode Touch Screen Controls

5.3 PW Mode

5.3.1. Using PW Mode

1. Perform the image scanning to get a good image in B mode or B+Color(DPI/DPDI) mode;

2. Press <PW> on the console to display sample line;

3. Use the trackball and touch controls to adjust the position of the sample line and the size and

angle of the sample gate;

4. Press <PW> on the console to enter B+PW or B+Color(PDI/DPDI)+PW mode and display

Doppler strip.

5. Adjust image parameters to optimize the Doppler strip.

6. When spectrum is displayed, pressing <Update> toggles between acquiring the Doppler strip and

acquiring the reference image.

5.3.2. PW Image Optimization

The following touch controls can be used to optimize the PW image.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

Filter

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 will display more shades of gray, while a low dynamic range will display fewer shades of gray and a more contrasty Doppler display.

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

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

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

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. In Duplex mode, either the Doppler strip or the reference image is updated continuously. In Triplex mode, both the Doppler strip and reference image are updated simultaneously.

Image Type

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

Steer

This control is only available for linear transducers and 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 waveforms.

Trace Side

Press one of the three options to specify which side of the Doppler baseline to take measurements from:

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

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Acclarix AX3 Series 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 increased sensitivity in the Doppler display and improved penetration, but the ALARA principle should be followed in actual clinical situations.

Table 5-3 PW Mode Touch Screen Controls

5.3.3. 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 primary PW gate to a shallower location until only one gate is displayed.

5.4 CW Mode

5.4.1. Using CW Mode

CW mode is only available on phased array transducer.

1. Perform the image scanning to get a good image in B mode or B+Color(DPI/DPDI) mode;

2. Press <CW> on the console to display sample line;

3. Use the trackball and touch controls to adjust the position of the sample line;

4. Press <CW> on the console to enter B+CW or B+Color(PDI/DPDI)+CW mode and display

Doppler strip.

5. Adjust image parameters to optimize the Doppler strip.

6. When spectrum is displayed, pressing <Update> toggles between acquiring the Doppler strip and

acquiring the reference image.

In CW mode, pressing on <PW> on the console will switch PW mode directly.

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Acclarix AX3 Series 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

Quick-Angle

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

Filter

Colorize

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

5.4.2. CW Image Optimization

The following touch controls can be used to optimize the CW image.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

Gray Map Tint

Adjusts the current post processing, either grayscale or tinted.

Dynamic Range

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

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.

Acoustic Power

Table 5-4 CW Mode Touch Screen Controls

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

Name

Control

Description

Colorize

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

Gray Map Tint

Adjusts the current postprocessing, either grayscale or tinted.

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.

5.5 M-mode

5.5.1. Using M-mode

1. Perform image scanning to get a good image in B mode;

2. Press <M> to display M strip and sample line;

3. Move the trackball to adjust the sample line;

4. Adjust image parameters to optimize M strip.

5.5.2. M-mode Image Optimization

The following touch controls can be used to optimize the M-mode image.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Imaging

Strip Size

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 displayed side-by-side with the B-mode image. When Off, the M-Mode strip is displayed 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). Off, Low, Med. and High settings 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 increased sensitivity and penetration in the image, but the ALARA principle should be followed in actual clinical situations.

Table 5-5 M-Mode Touch Screen Controls

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

No.

Model

Type

Application

Applied Region

C5-2Q

Convex

Abdomen Fetal / Obstetrics Urology Gynecology Musculoskeletal

Surface

E8-4Q

Micro Convex

Fetal / Obstetrics Gyncecology Trans-vaginal Trans-rectal Urology

Endocavity 3

L12-5Q

Linear

Small parts Peripheral Vascular Musculoskeletal

Surface

P5-1Q

Phased Array

Adult Cardiac Abdomen Pediatric Cardiac Adult Cephalic

Surface 5

L17-7Q

Linear

Small Parts Peripheral Vascular Musculoskeletal

Surface

6 Transducers and Biopsy

6.1 Transducers

Table 6-1 Transducer Model & Application

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

No.

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.

Center line mark

Indicates the center line position of the transducer, which are usually used for out-of-plane needle guide.

Transducer model

Displays the transducer model.

Needle-guided bracket fixing tabs and groves

Provides mounting support for the needle-guided bracket.

Transducer orientation mark

The side of orientation mark on the transducer corresponds to the side of orientation mark on the display screen

Transducer cable

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

Transducer connector

Connects the transducer to the ultrasound imaging system.

5 6

6.2 Using Transducers

Understanding a Transducer:

Figure 6-1 takes L12-5Q transducer to show an example of a transducer.

Figure 6-1 Typical transducer

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Orientation Mark

Image Orientation Mark

The image orientation mark on the display screen and on the transducer are shown as below. The side of orientation mark on the transducer corresponds to the side of orientation mark on the display screen. Ensure orientation marks on the display screen and transducer are on the same side prior to scanning.

Figure 6-2 Image Orientation Mark

Proper Use of Transducers

To extend the service life and maintain optimum transducer performance, please operate as follows:

 Inspect transducer cable, 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. The temperature should be below

45°C.

2. To avoid damaging the device, the disinfection method is limited to regular maintenance of

devices in hospitals. Disinfecting instruments should be cleaned first.

3. The coupling gel adapted to the transducer is a medical ultrasound coupling gel. Use only

ultrasound coupling gel that complies with local regulations.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Use of Transducer sheath

CAUTION

1. Always wear gloves to perform the following steps.

2. To minimize disease transmission, legally marketed, sterile transducer sheath is required to use

for intra-cavitary 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.

5. Before cleaning or disinfecting the transducer, remove the sheath gently and discard it. Put on a

new single-use sheath before using the transducer.

6. Use of protective sheath with natural rubber latex may lead to a severe anaphylactic reaction in

persons sensitive to the natural latex protein.

7. Transducer sheath should be used with all clinical situations where infection is a concern. To install transducer sheath:

1. Place an adequate amount of sterile coupling gel in the protective sheath and/or 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. Check and

eliminate bubbles between the surface of the transducer and the sheath. Be careful not to pierce the sheath.

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

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

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Transducer Applied Region

Transducer Type

Disinfecting Intensity

Disinfecting Method

Contact intact body surface

Body surface

LLD

Spraying or wiping

Contact mucous membrane

Endocavity

HLD

Immersion

Note: LLD=Low-level Disinfection; HLD=High-level disinfection

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.

6.3.1. Cleaning

The validated cleaning agents for cleaning the transducers are:

 Ethanol (75%)  Isopropanol (70%)

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

To clean the transducers:

1. Disconnect the transducer from the system.

2. Wipe the transducer cable with a soft cloth dampened with the cleaning solution until no visible

contaminants remain.

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

contaminants remain.

4. After cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water

until no visible cleaning agent remains.

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

6. Leave the transducer to air dry.

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

6.3.2. Disinfecting

Selecting a proper way to disinfect your transducers based on your transducer applied region:

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Disinfectants

Disinfecting Intensity

Disinfecting Method

Ethanol (75%)

LLD

Spraying or wiping

Isopropanol (70%)

LLD

Spraying or wiping

Cidex OPA (0.55%)

HLD

Immersion

Glutaraldehyde(1.8%-2.2%)

HLD

Immersion

The validated disinfectants for transducer are:

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.

4. Please cleaning the transducer prior to disinfection.

Disinfecting by spraying or wiping:

1. Disconnect the transducer from the system.

2. Wear protective gloves to prevent infection.

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

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

disinfectant solution. Follow the disinfectant manufacturer's recommended contact time and mode.

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

cloth or leave the transducer to air dry.

6. Inspect the transducer to ensure that there is no damage. Note: If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required for the

disinfection step.

Disinfecting by Immersion:

1. Disconnect the transducer from the system.

2. Wear protective gloves to prevent infection.

3. Prepare the disinfectant solution (Cidex OPA 0.55% or Glutaraldehyde(1.8%-2.2%)).

4. Place the cleaned and dried transducer in contact with the disinfectant (refers to figure 6-3 for the

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

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

cloth or leave the transducer to air dry.

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

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Disinfectant

E8-4Q

Figure 6-3 Depth of the Transducer Immerged into Disinfectant

WARNING

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

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

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

3. 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.

4. Use the immersion method to disinfect the intra-cavitary transducer.

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

concentration should not exceed the value provided above.

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

7. Patient contact area should be immersed into the solution while using the immersion method, but

should not exceed the depth shown in figure 6-3.

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

gas, steam, or heat. Severe damage may result.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

6.4 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 6.4.3) 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.

6.4.1. Installing Needle Guide Bracket

WARNING

1. For illustration purpose only, transducer and bracket may be shown without a protective sheath.

Always place a protective sheath on transducer and bracket to protect cross infection.

 BGK-C5-2/BGK-L40UB/BGK-002 The installation steps for BGK-C5-2, BGK-L40UB and BGK-002 brackets are the same. Here we take

one bracket for illustration.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Clamp

Locking Knob

Adjusting Knob

Needle Guide Path

Tab Release

Angle Knob

Structures:

Installation and Use Steps:

1. Place an appropriate amount of gel on transducer surface, and insert transducer into the sheath.

2. Loosen the locking knob to open the clamp of bracket. Attach the bracket to the transducer by

aligning the locating markers on the bracket and the transducer. Properly secure the clamp of bracket with the locking knob. Ensure the backet is firmly attached.

3. Loosen the angle knob to select a needle guide angle, and secure the angle knob.

4. Press the tab release and place the biopsy needle into the needle guide path. Use the adjusting

knob to properly secure the needle.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Clamp

Needle Guide Path

Locking Knob

5. After biopsy, press the tab release to remove the needle, and loosen the locking knob to remove

the bracket from the transducer.

 BGK-CR10UA Structures:

Installation and Use Steps:

1. Place an appropriate amount of gel on transducer surface, and insert transducer into the sheath.

2. Loosen the locking knob to open the clamp of bracket. Attach the bracket to the transducer by

aligning the locating markers on the bracket and the transducer.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Needle Guide Holder

Clamp

Locking Knob

3. Properly secure the clamp of bracket with the locking knob. Ensure the backet is firmly attached,

and then place the biopsy needle into the needle guide path.

 BGK-001/BGK-003 The installation steps for BGK-001 and BGK-003 brackets are the same. Here we take one bracket for

illustration.

Structures:

Installation and Use Steps:

1. Place an appropriate amount of gel on transducer surface, and insert transducer into the sheath.

2. Loosen the locking knob to open the clamp bracket. Attach the bracket to the transducer by

aligning the locating markers on the bracket and the transducer. Properly secure the clamp of bracket with the locking knob.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Specification

Depth

21G（1.0cm）

0.8 - 1.2 cm

21G（1.5cm）

1.3 - 1.7 cm

21G（2.0cm）

1.8 - 2.2 cm

3. Install the disposable Needle Guide.

a. Select appropriate disposable needle guide to achieve target depth from skin line:

b. Install the needle guide to the needle guide holder, and then put in the biopsy needle:

6.4.2. 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 angles. If the current transducer supports such a

guide then the Line paddle key appears. Pressing it selects guide lines of different angles. Each line represents a corresponding angle marked on the needle guide bracket.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Figure 6-4 Needle Guide Touch Screen

WARNING

1. To avoid patient injury when using a multi-angle bracket, make sure that the same angle(A, B, C

or D) is selected on both the bracket and the ultrasound system.

6.4.3. Calibrating the Needle Guide Line

WARNING

2. 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.

3. Do not use the needle guide bracket if the needle does not track with the guide during calibration.

Figure 6-5 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 Line paddle key to select a

guide line.

3. Press the Calibration button on the touch screen to display the Angle and Position paddle

button.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

Angle Line

 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.

4. Any changes will be saved as the default value automatically.

6.5 Needle Visualization

Needle Visualization is an image processing technology that enhances needle visibility. It is available in B-mode for all linear transducers.

Figure 6-6 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.  Shallow/Medium/Steep: press to enhance the needle visibility for different needle inserted

angles. For best results use the angle line that is closest to perpendicular to the needle path.

Figure 6-7 Touch Screen for Needle Enhancement Visualization

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Transducers and Biopsy

6.6 Center Line

The Center Line is a vertical dotted line displayed at the middle of the image field, representing the middle of ultrasound beam. The Center Line helps to locate the position and depth of a target disease focus for out-of-plane biopsy, lithotripsy and etc..

To use Center Line:

1. Press Center-Line on B-mode touch screen to activate Center Line.

2. A dotted center line is displayed vertically at the middle of the image field. The position and

direction of the center line cannot be changed.

3. Move the transducer to locate the target.

4. Use distance measurement to obtain the depth of the target. Note: Center Line is not available on Endocavity transducer E8-4Q.

6.7 Needle Guide Bracket Cleaning and Sterilization

NOTE:

1. Use proper sterilization technique at all times when performing a biopsy.

2. Ensure that protective gloves are worn.

WARNING

The needle guide bracket kits are not disinfected or sterilized before delivery. The operators must clean and sterilize the needle guide bracket kits before and after each use.

To clean a needle guide bracket:

1. Disconnect the needle guide bracket from the transducer after each use, and remove all visible

residues from the needle guide bracket using a small and soft-bristled brush or other similar devices. Do the cleaning quickly before the needle guide bracket dries out.

2. Soak the needle guide bracket in the cleaning solution (Ethanol 75% or Isopropanol 70%) for at

least five minutes. Use a soft-bristled brush to clean the needle guide bracket during the soaking. If the residue is hard to be removed, repeat the soaking procedures. Take out the needle guide bracket from the cleanser and wipe all residues with a dry cloth.

To sterilize a needle guide bracket:

Sterilize the Needle Guide Assembly by autoclaving for at least four minutes at 132oC.

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Acclarix AX3 Series 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

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

Show or hide a touch screen keyboard.

Exit

Press to exit the comments function.

7 Features

7.1 Comment

The Comment function allows 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 touchscreen for the Comment function. The top portion of the screen shows comments that are pre-defined in pre-sets. See section 10 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

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features

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 type the desired text.

 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. Rotate the <Angle> knob on the console to adjust the orientation of the arrow.

5. Press <Set> key to confirm the arrow and you can now enter text at the end of the arrow.

If the "Continuous Arrow" is checked on General Comment Settings Screen, pressing <Set> key will confirm the arrow and display a second arrow. Repetition of this will add multiple arrows.

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.

2. 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, body marks, and

measurements.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features

Button

Description

Delete

Delete the graphics on the image area

Exit

Press to exit the body mark function.

7.2 Body Mark

Body Mark allows you add a body mark 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 body marks that are pre-defined in pre-sets. See section 10 for details on how to configure these. The bottom portion of the screen shows controls available while the Body Mark function is active. Table 7-2 gives an overview of these controls.

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 body mark graphic appears on the main screen with the transducer icon shown in the default position.

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

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

changed with the <Angle> knob on the console.

4. Press <Update> key and roll the trackball to move the position of body mark graphic.

The <Update> key can be used to toggle between moving the transducer icon and moving the body mark graphic.

5. Press <Set> to complete the adding of a body mark. Deleting a body mark:

There are two ways of deleting a body mark graphic:

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

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features

Indicator Indicator

7.3 Dual Image Display

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.

Dual image display is invoked by pressing the Dual hard key on the console. Each single press of Dual key during real-time imaging activates the image on one side and the image on other side becomes frozen.

In Dual mode, press the Single hard key on the console to return to single image real-time scanning.

Dual Exit Exit Dual using any of the following:

 Pressing the B, M, PW, CW hard key.  Transducer change, preset recall, or new exam.

Dual image display is available in B and Color Doppler mode.

7.4 Zoom

Zoom mode is available on the live or frozen image in B mode and Color mode. When the indicator of zoom function illuminates, rotate the physical Zoom knob on the console, as shown below, to zoom an image. The indicator of zoom function will illuminate whenever zoom function is available.

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

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Features

Current Frame

Total Frames

Start Frame

Review Mark

End Frame

Current Frame

Total Frames

Start Frame

Review Mark

End Frame

7.5 Cine Review

Press <Freeze> key on the console to freeze the image or select a stored cine clip, and the cine bar is displayed on the bottom of the screen, as shown below.

Figure 7-3 Typical Cine Bar in B/Color Mode

Figure 7-4 Typical Cine Bar in PW/CW/M Mode

The cine can be reviewed manually or automatically.

Manual Review:

Move the trackball to review the cine frame by frame. As the trackball moves, the current cine number is displayed on the right of the cine bar.

Auto Review:

1. Set the start frame: in manual review status move the trackball to review frame by frame until the

frame that you want to set as the start point, press Set Start button on the touch screen to select a frame as the start frame.

2. Set the end frame: in manual review status, move the trackball to review frame by frame until the

frame that you want to set as the end point, press Set End button on the touch screen to select a frame as the end frame.

3. Adjust the review speed by the Speed paddle key.

4. Press Play button on the touch screen to review the cine within the set region automatically.

In dual imaging, freeze the image, and press to toggle between the two windows. The cine bar corresponds to the currently active image, and you can perform manual/auto review for the currently active image.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

8 Measurements and Reports

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 8-1 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. The upper part of the touch screen shows Application Measurements. These are different for each imaging mode and each preset.

Figure 8-1 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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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

Figure 8-2 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 the trackball 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.

8.1 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 used 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.

Note: The generic measurements supported in each imaging mode may vary with different exam presets.

The following sections describe all the generic measurements supported in each imaging mode.

8.1.1. B-mode Generic Measurements

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

 Distance  Circ/Area  Angle  Volume

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

 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. Select Distance from the touch screen.

3. Move the caliper to the start point.

4. Press the <Set> key to fix the start point.

5. Move the caliper to the end point. Presses of the <Update> key will toggle between active calipers, allowing you to adjust the

position of start point and end point.

6. Press the <Set> key to fix the end point and complete the measurement.

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

To measure Area or Circumference with an Ellipse:

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

2. Select Circ/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 start point.

4. Press the <Set> key to fix the start point.

5. Move the caliper and press the <Set> key to fix the end point. An ellipse appears and can be adjusted with the trackball. Presses of the <Update> key will toggle between active calipers, allowing you to adjust the ellipse diameter.

6. Press the <Set> key to complete the measurement.

To measure Area or Circumference with a Trace:

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

2. Select Circ/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 start point.

4. Press the <Set> key to fix the start point and start drawing the trace.

5. Moving the caliper to mark the trace outline.

6. Press the <Set> 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. Select Angle from the touch screen.

3. Move the caliper to the vertex of the angle you are measuring, and press the <Set> key to fix the first point.

4. Move the caliper to one end of the angle, and press the <Set> key to fix the second point.

5. Move the caliper to the other end of the angle.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

Presses of the <Update> key will toggle between active calipers, allowing you to adjust the position of the three points that make up the angle.

6. Press the <Set> key to fix the third point and complete the angle measurement.

Volume: Volume can be measured with 3 Distances.

To measure Volume with 3 Distances:

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

2. Select Volume from the touch screen.

3. Move the caliper to the start point.

4. Press the <Set> key to fix the start point.

5. Move the caliper to the end point. Presses of the <Update> key will toggle between active calipers, allowing you to adjust the position of start point and end point.

6. Press the <Set> key to fix the end point and complete the measurement of the first distance.

7. Repeat step 3~6 to complete the measurements of the second and third distance. Then the Volume measurement result displays.

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. 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 start point.

4. Press the <Set> key to fix the start pint.

5. Move the caliper to the end point. Presses of the <Update> key will toggle between active calipers, allowing you to adjust the position of start point and end point.

6. Press the <Set> key to complete the measurement of the first distance.

7. Repeat step 3~6 to complete the measurement of the second distance. Then the Stenosis measurement result displays.

To measure Stenosis with Ellipses:

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

2. 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 start point.

4. Press the <Set> key to fix the start point.

6. Press the <Set> key to complete the measurement of the first ellipse.

7. Repeat step 3~6 to complete the measurement of the second Ellipse. Then Stenosis measurement result displays.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports To measure Stenosis with Traces:

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

2. 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 start point.

4. Press the <Set> key to fix the start point and start drawing the trace.

5. Moving the caliper to mark the trace outline.

6. Press the <Set> key to complete the trace.

7. Repeat step 3~6 to complete the measurement of the second trace. Then Stenosis measurement result displays.

8.1.2. Strip Doppler Generic Measurements

The system supports the following types of generic strip Doppler measurements:

 Caliper  Trace  Auto Trace  HR (Heart Rate)  RI (Resistive Index)  TEI  dp/dt

Caliper: The Caliper measurement can provide a wide range of results, as shown below. The actual results displayed will depend on the results you selected in Tool Options.

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

To use the Caliper measurement:

1. Invoke the Measure Function on a Doppler strip.

2. Select Caliper from the touch screen.

3. Move the caliper to the PS point.

4. Press the <Set> key to fix the PS point.

5. Move the caliper to the ED point. Presses of the <Update> key will toggle between active calipers, allowing you to re-position

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

the PS point or ED point.

6. Press the <Set> key to fix the ED point and complete the measurement. 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, as shown below. The actual results displayed will depend on the results you selected in Tool Options.

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

NOTE: Trace measurement can only be activated on a frozen image.

To use the Trace measurement with a draw method:

1. Freeze the strip and invoke the Measure Function on a Doppler strip.

2. Select Trace from the touch screen. Trace can be done with a Draw. Draw will follow your movements

3. Move the caliper to the start point.

4. Press the <Set> key to fix the start point and start drawing the trace.

5. Moving the caliper to mark the trace outline. Presses of the <Update> key will toggle between active calipers, allowing you to adjust the positions of the PS or ED points in the trace.

6. Press the<Set> key to complete the trace.

Auto Trace: Auto Trace is capable of measuring the maximum and/or mean blood flow on a frozen Doppler strip. Each result that it calculates is associated with either the maximum or the mean value. Auto Trace measurement can provide a wide range of results, as shown below. The actual results displayed will depend on the results you selected in Tool Options.

 PS  ED  MD  TAMax  TAMean  PGmax

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

 PGmean  PI  RI  S/D  VTI  Time  AT  DT  HR

NOTE:

1. Auto trace measurement can only be activated on a frozen Doppler strip..

2. Live Auto Trace is available as a separate feature on the Doppler touch screen. To activate Auto Trace in real time mode, press Auto Trace button on PW touch screen.

To use the Auto Trace measurement:

1. Freeze the strip and invoke the Measure Function on a Doppler strip.

2. Select Auto Trace from the touch screen.

3. 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.

HR: The HR measurement tool can provide the heart rate calculation.

To use the HR measurement tool:

1. Invoke the Measure Function on a Doppler strip.

2. Select HR from the touch screen.

3. Move the caliper to the first heartbeat.

4. Press the <Set> key to fix the start point.

5. Move the caliper to the next beat. Presses of the <Update> key will toggle between active calipers, allowing you to adjust the position of start point and end point.

6. Press the <Set> key to fix the end point and complete HR measurement.

RI: The RI measurement can provide a wide range of results, as shown below. The actual results displayed will depend on the results you selected in Tool Options..

 PS  ED  RI  S/D

To use the RI measurement tool:

1. Invoke the Measure Function on a Doppler strip.

2. Select RI from the touch screen.

3. Move the caliper to the PS point.

4. Press the <Set> key to fix the PS point.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

5. Move the caliper to the ED point. Presses of the <Update> key will toggle between active calipers, allowing you to re-position the PS point or ED point.

6. Press the <Set> key to fix the ED point and complete RI measurement.

TEI: The TEI index measurement is useful for the assessment of ventricular systolic and diastolic function. Higher TEI index indicates decreased ventricular function.

To use the TEI measurement:

1. Invoke the Measure Function on a Doppler strip.

2. Select TEI from the touch screen.

3. Measure Time A (Mitral Valve Close-Open Duration ) by caliper pairs.

4. Measure Time B (Ventricular Ejection Time) by caliper pairs.

5. The system calculates the TEI index automatically. The illustration is shown below:

dp/dt: The left ventricular dp/dt measurement is a useful index for evaluating myocardial contractility.

To use the dp/dt measurement:

1. Invoke the Measure Function on a Doppler strip.

2. Select dp/dt from the touch screen.

3. Move the caliper to the position at the 100 cm/s scale on one of the cardiac cycles and press the <Set> key.

4. Move the caliper to the position at 300 cm/s scale on the same cardiac cycle and press the <Set> key. The time difference "

5. The system calculates dp/dt based on the

dt "

between the two positions come out.

"dt "

value

. Formula:

dp/dt = 32/dt (mmHg/s)

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

8.1.3. M-mode Generic Measurements

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

 Caliper  HR (Heart Rate)

Caliper: The Caliper measurement can provide a wide range of results, as shown below:

 Distance  Time  Slope

To use the Caliper measurement:

1. Invoke the Measure Function on an M-mode strip.

2. Select Caliper from the touch screen.

3. Move the Caliper to the start point.

4. Press the <Set> key to fix the start point.

5. Move caliper to the end point. Presses of the <Update> key will toggle between active calipers, allowing you to adjust the position of start point and end point.

6. Press the <Set> key to fix the end point and complete the measurement.

HR: The HR measurement tool can provide the heart rate calculation.

To use the HR measurement tool:

1. Invoke the Measure Function on an M-mode strip.

2. Select HR from the touch screen.

3. Move the caliper to the first heartbeat.

4. Press the <Set> key to fix the start point.

5. Move the caliper to the next beat. Presses of the <Update> key will toggle between active calipers, allowing you to adjust the position of start point and end point.

6. Press the <Set> key to fix the end point and complete HR measurement.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

8.2 Application Measurements

Application Measurements have a pre-defined meaning and can be entered into a report. The system 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

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. The results are entered into the report when the measurement is done.

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

Please refer to the Advanced User Manual for the calculation formulas and references.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

Abdomen Measurement

Description

Tool

Section 1: B-mode Measurements

1.1

Liver

Liver L

Liver Length

Caliper

Liver W

Liver Width

Liver H

Liver Height

Portal Vein

Portal Vein Diameter

CHD

Common Hepatic Duct

1.2

Gall Bladder GB L

Gallbladder Length

GB H

Gallbladder Height

GB wall th

Gallbladder wall thickness

CBD

Common Bile Duct

1.3

Pancreas Panc duct

Pancreatic duct

Panc head

Pancreatic head

Panc body

Pancreatic body

Panc tail

Pancreatic tail

1.4

Spleen Spleen L

Spleen Length

Spleen H

Spleen Height

1.5

Renal Renal L

Renal Length

Renal W

Renal Width

Renal H

Renal Height

Cortex

Renal Cortex thickness

1.6

Aorta Diam

Aorta Diameter

Section 2: Doppler Measurements

2.1

Abdominal Aorta

Caliper*

Trace*

Auto Trace*

2.2

SMA

Superior Mesenteric Artery

2.3

IMA

Inferior Mesenteric Artery

2.4

Hepatic Artery

2.5

Splenic A

Splenic Artery

2.6

Renal A

Renal Artery

2.7

Portal V

Portal Vein

Caliper

2.8

IVC

Inferior Vena Cava

2.9

M Portal V

Main Portal Vein

2.10

Hepatic V

Hepatic Vein

2.11

M Hepatic V

Middle Hepatic Vein

2.12

Splenic V

Splenic Vein

2.13

SMV

Superior Mesenteric Vein

8.2.1. Abdomen Measurements

Abdomen measurements include liver, gall bladder, pancreas, spleen, renal and Aorta Diam.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

Abdomen Measurement

Description

Tool

2.14

IMV

Inferior Mesenteric Vein

No.

Gynecology Measurement

Description

Tool

Section 1: B-mode Measurements

1.1

Uterus

Uterus L

Uterus Length

Caliper

Uterus W

Uterus Width

Uterus H

Uterus Height

Endo

Endometrium Thickness

UT-Cavity

Uterine Cavity Depth

1.2

Cervix Cervix L

Cervix Length

Cervix W

Cervix Width

Cervix H

Cervix Height

1.3

Ovary Ovary L

Ovary Length

Ovary W

Ovary Width

Ovary H

Ovary Height

1.4

Cyst** Cyst D1

Cyst Distance 1

Cyst D2

Cyst Distance 2

Cyst D3

Cyst Distance 3

1.5

Follicle** Fol. D1

Follicle Distance 1

Fol. D2

Follicle Distance 2

Fol. D3

Follicle Distance 3

1.6

Fluid POD

Fluid Pouch of Douglas

Section 2: Doppler Measurements

2.1

Ovary A

Ovary Artery

Caliper*

Trace*

Auto Trace*

2.2

Ut. A

Uterine Artery

Table 8-1 Abdomen Measurement

* The tools can be switched by Tool Options in the touch screen after the Measurement is selected.

8.2.2. Gynecology Measurements

Gynecology measurements include uterus and ovary.

*The tools can be switched by Tool Options in the touch screen after the Measurement is selected. ** The measurement method including 1 Distance, 2 Distances and 3 Distances can be configured in

Measure Preset. See Section 10.3.5 for details.

Table 8-2 Gynecology Measurements

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

OB Measurement

Description

Tool

Section 1: B-mode Measurements

1.1

Gestational Sac

Caliper

1.2

Yolk Sac

1.3

CRL

Crown Rump Length

1.4

Nuchal Translucency

1.5

Nuchal Fold

1.6

BPD

Biparietal Diameter

1.7

OFD

Occipital Frontal Diameter

1.8

Head Circumference

Ellipse*

Trace*

1.9

Abdominal Circumference

1.10

Femur Length

Caliper

1.11

TAD

Transverse Abdominal Diameter

1.12

APAD

Anteroposterior Abdominal Diameter

1.13

CER

Cerebellum Diameter

1.14

HUM

Humerus Length

1.15

ULNA

Ulna Length

1.16

RAD

Radius Length

1.17

TIB

Tibia Length

1.18

FIB

Fibula Length

1.19

APTD

Anteroposterior Trunk Diameter

1.20

TTD

Transverse Trunk Diameter

1.21

FTA

Fetal Trunk Area

Ellipse*

Trace*

1.22

THD

Thoracic Diameter

Caliper

1.23

Foot

Foot Length

8.2.3. Obstetrics Measurements

Obstetric measurements are used to calculate the GA (Gestation Age), EDD (Estimated Delivery Date) and EFW (Estimated Fetus Weight).

Multiple fetuses

The Obstetric package supports measurements and reports on up to four fetuses. If you know the number of fetuses at the start of the exam then you can enter this in the Patient page (see section 4.4). When the number of fetuses is known the system adjusts the user interface to optimize for that number. If no information is entered about the number of fetuses the system will assume there is one.

Except where noted below, every measurement and calculation supports multiple fetuses. The system supports the B/D/M obstetric measurements.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

OB Measurement

Description

Tool

1.24

Deepest Pocket

1.25

AFI**

Amniotic Fluid Index

Caliper

1.26

RV Diam

Right Ventricular Diameter

Caliper

1.27

RA Diam

Right Atrium Diameter

1.28

RVOT Diam

Right Ventricular Outflow Tract Diameter

1.29

LV Diam

Left Ventricular Diameter

1.30

LA Diam

Left Atrium Diameter

1.31

LVOT Diam

Left Ventricular Outflow Tract Diameter

1.32

Asc Aorta

Ascending Aorta Diameter

1.33

Ao Arch Diam

Aorta Arch Diameter

1.34

Ao Isthmus

Aorta Isthmus Diameter

1.35

Desc Aorta

Descending Aorta Diameter

1.36

MPA Diam

Main Pulmonary Artery

1.37

Ductus A

Duct Arteriosus Diameter

1.38

CTAR A1

Cardio/Thorax area ratio

Cardio Area

Trace

Thorax Area

Ellipse

Section 2: Doppler Measurements

2.1

MCA

Middle Cerebral Artery

Caliper*

Trace*

Auto Trace*

2.2

Umb. A

Umbilical Artery

2.3

Planenta A**

Placenta Artery

2.4

Ductus V

Ductus Venosus

Caliper

2.5

Mitral Valve

2.6

Tricuspid Valve

2.7

MPV

Main Pulmonary Vein

2.8

Ductus A

Duct Arteriosus

2.9

Ovary A**

Ovary Artery

Caliper*

Trace*

Auto Trace*

2.10

Ut. A**

Uterine Artery

2.11

Fetal Ao

Fetal Aorta

2.12

Desc Aorta

Descending Aorta

2.13

FHR***

Fetal Heart Rate (1 cycles)

Caliper

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

OB Measurement

Description

Tool

Section 3: M-mode Measurements

3.1

FHR***

Fetal Heart Rate

Caliper

No.

Cardiac Measurement

Description

Tool

Section 1: B-mode Measurements

1.1

LV Simpson

A4C Dias.

Left Ventricular apical four-chamber views at End-diastole

Simpson

A4C Sys.

Left Ventricular apical four-chamber views at End-systole

A2C Dias.

Left Ventricular apical two-chamber views at End-diastole

A2C Sys.

Left Ventricular apical two-chamber views at End-systole

1.2

Vent. Dim (Ventricular Diameter)

RVAWd

Right Ventricular Anterior Wall Thickness at End-diastole

Caliper

RVIDd

Right Ventricular Internal Diameter at end-diastole

IVSTd

Interventricular Septal Thickness at End-diastole

IVSTs

Interventricular Septal Thickness at End-systole

LVIDd

Left Ventricular Internal Diameter at End-diastole

LVIDs

Left Ventricular Internal Diameter at End-systole

LVPWd

Left Ventricular Posterior Wall Thickness at End-diastole

LVPWs

Left Ventricular Posterior Wall Thickness at End-systole

1.3

PV Diam

Pulmonary Valve Diameter

1.4

RVDs

Right Ventricular Diameter at end-systole

1.5

RA Length

Right Atrium Length Diameter

1.6

RA Width

Right Atrium Width Diameter

1.7

LA Length

Left Atrium Length Diameter

Table 8-3: OB Measurements * The tools can be switched by Tool Options in the touch screen after the Measurement is selected. **Multiple Fetuses N/A. ***System provides 1-8 cycles for HR measurement, depending on measurement setup.

8.2.4. Cardiac Measurements

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

Cardiac Measurement

Description

Tool

1.8

LA Width

Left Atrium Width Diameter

1.9

Ao Asc

Ascending Aorta Diameter

1.10

AoD

Aortic Root Diameter

1.11

LVOT Diam

Left Ventricular Outflow Tract

1.12

RVOT Diam

Right Ventricular Outflow Tract

Section 2: Doppler Measurements

2.1

MV(Mitral Valve)

E/A

E-wave Velocity/ A-wave Velocity

Caliper

MV PHT

Mitral Valve Pressure Half Time

MV Trace

Mitral Valve Trace

Trace

IVRT

Isovelocity Relaxation Time

Caliper

MV A Dur

Mitral Valve A-wave Duration

MV DecT

Mitral Valve Deceleration Time

2.2

TV(Tricuspi d Valve)

TV Trace

Tricuspid Valve Trace

Trace

TV Vmax

Tricuspid Valve Maximum Velocity

Caliper

2.3

AoV(Aortic Valve)

LVOT Trace

Left ventricular outflow tract Trace

Trace

LVOT Vmax

Left ventricular outflow tract maximum Velocity

Caliper

AoV Trace

Aortic Valve Trace

Trace

AoV Vmax

Aortic Valve maximum Velocity

Caliper

2.4

PV (Pulmonic

Valve)

PV Trace

Pulmonic Valve Trace

Trace

PV Vmax

Pulmonic Valve maximum Velocity

Caliper

2.5

P Vein (Pulmonic

Vein)

PVein S Vel

Pulmonic Veins Systole Velocity

Caliper

PVein D Vel

Pulmonic Veins Diastole Velocity

PV A Vel

A Point Reverse Velocity

2.6

HR**

Heart rate

Caliper

Section 3: M-mode Measurements

3.1

Vent. Dim (Ventricular

Diameter)

RVAWd

Right Ventricular Anterior Wall Thickness at End-diastole

Caliper

RVIDd

Right Ventricular Internal Diameter at end-diastole

IVSTd

Interventricular Septal Thickness at End-diastole

LVIDd

Left Ventricular Internal Diameter at End-diastole

LVPWd

Left Ventricular Posterior Wall

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

Cardiac Measurement

Description

Tool

Thickness at End-diastole

IVSTs

Interventricular Septal Thickness at End-systole

LVIDs

Left Ventricular Internal Diameter at End-systole

LVPWs

Left Ventricular Posterior Wall Thickness at End-systole

3.2

LVET

Left Ventricular Ejection Time

3.3

MV(Mitral Valve)

E-F Slope

Mitral Valve E-F slope

EPSS

E point septal separation

3.4

LA/Ao LA

Left atrial diameter

AoD

Aortic root diameter

RVOT Diam

Right Ventricular outflow tract

3.5

HR**

Heart rate

Table 8-4 Cardiac Measurements * The tools can be switched by Tool Options in the touch screen after the Measurement is selected. **System provides 1-8 cycles for HR measurement, depending on measurement setup.

Simpson’s Method of Disks (MOD)

Simpson‟s MOD is a method used to calculate LV diastolic and systolic volumes and ejection fraction. Simpson‟s MOD is available in the Cardiac presets.

To use the Simpson‟s MOD 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.

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

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. Pivot the Point D caliper to a new desired position if necessary.

7. Press <Set> key to complete the measurement.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

Small Parts Measurement

Description

Tool

Section 1: B-mode Measurements

1.1

Thyroid

THY L

Thyroid Length

Caliper

THY W

Thyroid Width

THY H

Thyroid Height

Isthmus

Thyroid Isthmus

1.2

Breast

Lesion 1

Breast Lesion 1

Lesion 2

Breast Lesion 2

Lesion 3

Breast Lesion 3

Lesion 4

Breast Lesion 4

Lesion 5

Breast Lesion 5

1.3

Testis

Testis L

Testis Length

Testis W

Testis Width

Testis H

Testis Height

Section 2: Doppler Measurements

2.1

STA

Superior Thyroid Artery

Caliper*

Trace*

Auto Trace*

2.2

ITA

Inferior Thyroid Artery

No.

Urology Measurement

Description

Tool

Section 1: B-mode Measurements

1.1

Renal

Renal L

Renal Length

Caliper

Renal W

Renal Width

Renal H

Renal Height

Cortex

Renal Cortex thickness

1.2

Bladder

Pre-BL L

Pre-void Bladder Length

8.2.5. Small Parts Measurements

Small Parts measurements include thyroid and breast.

* The tools can be switched by Tool Options in the touch screen after the Measurement is selected.

8.2.6. Urology Measurements

Urology measurements include renal, bladder, prostate, seminal and testicle.

Table 8-5 Small Parts Measurement

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

Urology Measurement

Description

Tool

Pre-BL W

Pre-void Bladder Width

Pre-BL H

Pre-void Bladder Height

Post-BL L

Post-void Bladder Length

Post-BL W

Post-void Bladder Width

Post-BL H

Post-void Bladder Height

1.3

Prostate Prostate L

Prostate Length

Prostate W

Prostate Width

Prostate H

Prostate Height

1.4

Seminal Seminal L

Seminal Length

Seminal W

Seminal Width

Seminal H

Seminal Height

1.5

Testis Testis L

Testis Length

Testis W

Testis Width

Testis H

Testis Height

Section 2: Doppler Measurements

2.1

Renal A

Renal Artery

Caliper*

Trace*

Auto Trace*

2.2

Arcuate A

Arcuate Artery

2.3

Seg. A

Segmental Artery

2.4

Int. A

Interlobar Artery

No.

Vascular

Measurement

Description

Tool

Section 1: B-mode Measurements

1.1

CCA IMT

Common Carotid Artery Intima-Media Thickness

Caliper

1.2

ICA IMT

Internal Carotid Artery Intima-Media Thickness

1.3

BIF IMT

Carotid Artery Bifurcation Intima-Media Thickness

1.4

VF Area

Volume Flow Area

Section 2: Doppler Measurements

2.1

CCA

Common Carotid Artery

Caliper*

Trace*

Auto Trace*

2.2

ECA

External Carotid Artery

2.3

ICA

Internal Carotid Artery

Table 8-6 Urology Measurements * The tools can be switched by Tool Options in the touch screen after the Measurement is selected.

8.2.7. Vascular Measurements

Vascular measurements include IMT in B-Mode, Carotid and Artery in Doppler Mode.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

Vascular

Measurement

Description

Tool

2.4

Vert Artery

2.5

SUBC A

Subclavian Artery

2.6

Axill A

Axillary Artery

2.7

Brach A

Brachial Artery

2.8

Ulnar A

Ulnar Artery

2.9

Radial A

Radial Artery

2.10

CFA

Common Femoral Artery

2.11

DFA

Deep Femoral Artery

2.12

SFA

Superficial Femoral Artery

2.13

CIA

Common Iliac Artery

2.14

EIA

External Iliac Artery

2.15

IIA

Internal Iliac Artery

2.16

Pop A

Popliteal Artery

2.17

Peron A

Peroneal Artery

2.18

PTA

Posterior Tibial Artery

2.19

ATA

Anterior Tibial Artery

2.20

DPA

Dorsalis Pedis Artery

2.21

SUBC V

Subclavian Vein

Caliper

2.22

Axill V

Axillary Vein

2.23

Brach V

Brachial Vein

2.24

Cepha V

Cephalic Vein

2.25

Basilic V

Basilic Vein

2.26

Ulnar V

Ulnar Vein

2.27

Radial V

Radial Vein

2.28

M Cubital V

Median Cubital Vein

2.29

CFV

Common Femoral Vein

2.30

DFV

Deep Femoral Vein

2.31

SFV

Superficial Femoral Vein

2.32

CIV

Common Iliac Vein

2.33

EIV

External Iliac Vein

2.34

IIV

Internal Iliac Vein

2.35

Saph V

Great Saphenous Vein

2.36

Pop V

Popliteal Vein

2.37

Peron V

Peroneal Vein

2.38

PTV

Posterior Tibial Vein

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

No.

Vascular

Measurement

Description

Tool

2.39

ATV

Anterior Tibial Vein

2.40

SSV

Small Saphenous Vein

2.41

HR**

Heart Rate

2.42

VF TAMean

Volume Flow Time Average Mean Velocity

Auto Trace

2.43

ACA

Anterior Cerebral Artery

Auto Trace

2.44

MCA

Middle Cerebral Artery

2.45

PCA

Posterior Cerebral Artery

2.46

ACoA

Anterior Communicating Artery

2.47

PCoA

Posterior Communicating Artery

2.48

Basilar Artery

2.49

Vertebral Artery

2.50

ICA

Internal Carotid Artery

Table 8-7 Vascular Measurements * The tools can be switched by Tool Options in the touch screen after the Measurement is selected. **System provides 1-8 cycles for HR measurement, depending on measurement setup.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

8.3 Worksheet and Report

Worksheet is available at any time during an exam, and is displayed as default on the main screen. Report contains the information from a worksheet but it is formatted in a slightly different manner.

8.3.1. Worksheet

To view a worksheet:

Press <Report> key on the console to open worksheet screen. A worksheet includes: Patient Information, Measure/Calculation data and Comments.

Figure 8-3 2D Worksheet Main Screen Display

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

Figure 8-4 Worksheet Touch Screen Display(OB as Example) There is a group of radio button that includes: Report, Worksheet and Growth Curve. Note: Radio Buttons are buttons where only one is active at any time. Activating one will de-activate all

others

 Press Report button on the touch screen to get the report page.  Press Worksheet button on the touch screen to switch back to the worksheet page.  Press Growth Curve button on the touch screen to access the fetal growth curves. It is only

available in OB worksheet, and is not displayed for any other preset.

 2D, M, Doppler: Press these buttons to display or hide separate measurement data by image

modes. The three buttons are on status as default, and user can switch it to off associated section. Each of these sections will start to display on a new page in worksheet.

 Expand: Press to expand and list all available measurements of current measure preset no

matter whether it is measured or not when it is on, and contracts unmeasured items when it is off. All those measured items are always displayed, regardless it is in current measure preset or not.

 Comment: Press to display or hide comment section. This is an editable field for user to type any

diagnosis or treatment comments.

 Fetus Compare: Click it to get the pages to compare multiple fetus data in one page. It only

shows summary data for each fetus. It is available only in multiple fetus situations.

 Fetus A, Fetus B, Fetus C, Fetus D: There is a group of radio button to switch fetus, and

worksheet main screen page shows data of selected fetus. It is only available in multiple fetus situations, and the number of enabled button equals current fetus number which is determined in patient information page.

 Page: Press to switch worksheet page in multiple pages. This is disabled when there is only one

page.

To edit a worksheet:

Move the cursor over an editable field such as a measurement result, and press the <Set> key. A touch QWERTY is automatically invoked. Type in your changes and press the Enter key to save the changes. After editing a result, an "underline" will be displayed below the value to indicate this is a

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports manually edited value.

Figure 8-5 Editing a measurement in Worksheet

8.3.2. OB Worksheet

Please see previous section for an overview of reports and worksheets. This section describes worksheet capabilities that are unique to OB. Figure 8-7 shows an example of the OB worksheet.

Figure 8-6 OB Worksheet With Expand on.

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

A: LMP: The LMP is displayed on the first page of the report. If the LMP was entered on the

Patient page that date is transferred to here.

B: GA: Two different versions of the GA are displayed:

 Clinical GA: Calculated from the LMP.  GA(CUA) or GA(AUA): Displays Composite Ultrasound Age(CUA) or Average Ultrasound

Age(AUA), depending the Default GA display configured in Measure Preset(see section

10.3.5 for details). C: EDD: Two different versions of the EDD are displayed based on the two GA values. D: Reference: Change the equation used to calculate the GA. E: CUA/AUA: These checkboxes let you decide which results are included in the CUA or AUA

calculation. CUA is calculated from the selected BPD, HC, AC and/or FL measurement result; AUA is the averaged value of the selected GAs calculated from single parameter including BPD, HC, AC, FL etc. Whether CUA or AUA is displayed depends on the Default GA display configured in Measure Preset(see section 10.3.5 for details).

F: EFW reference: Change the equation used to calculate the estimated fetal weight.

8.3.3. Growth Curve

OB Growth Curve indicates predicted fetal growth patterns according to the selected reference for a measurement or calculation. A growth curve graph can display information acquired in the current exam. Multiple fetus data can be display in the same graphic to compare their growth trending details.

For each growth curve graph, there is a drop-down list for selecting specific measurement or calculation, and a drop-down list for selecting specific reference of selected measurement or calculation. Selecting one of them, the growth curve graph will change accordingly.

Figure 8-7 Growth Curve Graph

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

To view a growth curve graph:

Press the <Report> hard key to enter the Worksheet, and then press the Growth Curve button on the touch screen to display the Growth Curve Graph.

Figure 8-8 Growth Curve Touch Screen Following controls are invoked by Growth Curve button.  Single/Quad: press to select the number of the growth curve graph for display.

Figure 8-9 Quad Growth Curve Graph

 Fetus Compare: Press to display multiple fetus data in the same graphic for comparing their

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

data directly .It appears only in multiple fetus situations, and the fetus number is determined by which is entered in patient information.

Figure 8-10 Comparing fetus in a growth curve graph

 Fetus A, Fetus B, Fetus C, Fetus D：There is a group of radio button to switch fetus, and the

growth curve graph shows data of selected fetus. It is only available in multiple fetus situations, and the number of enabled button equals current fetus number which is determined in patient information page. It is disabled when Fetus Compare is on.

8.3.4. Report

Press the <Report> hard key to enter the Worksheet, and then press the Report button on the touch screen to display the Report screen. A report includes: Header, Patient Information, Images, Measurement/Calculation data, Comments and Sonographer signature .

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Measurements and Reports

Figure 8-11 Report Main Screen The middle part of the main screen is the general layout of a report. On the left side of the main screen, you can set the layout of the report:

 Auto Adjust: Automatically adjusts the layout of the report.  Image Column: Selects the column number and the images will be displayed accordingly.

On the right side of the main screen, you can select images to add into the report. Maximum 21 images can be added to the report.

Figure 8-12 Report Touch Screen

Save As: Press it to store the report as PDF file to external storage. Preview: Press it to invoke print preview before print. Then switching report pages and zooming in

report are supported. Print: Press it to print the report when connecting a USB report printer.

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EDAN INSTRUMENTS AX3EDAN User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual