EDAN INSTRUMENTS AX8EDAN User Manual

Preface

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

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

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

Contact Information:

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

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

Contents

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

III

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction

1 Introduction

1.1 Intended Use/ Indications for Use

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

health professional for ultrasound evaluations. Specific clinical applications include:

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

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

health professional for ultrasound evaluations. Specific clinical applications include:

 Adult Cephalic*

1.2 Contra-indications

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

1.3 Device Description

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction

No.

Symbol

Definition

1 Serial Number

P/N

Part Number

3 Date of Manufacture

4 Manufacturer

5 Operating instructions

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

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

Caution

9 Biological Risks

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

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

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

approved for use until finishing the related registration.

1.4 Labeling Symbols

The following labels are used on the Acclarix AX8 system:

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Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction

Authorized Representative in the European Community

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

General Symbol for Recovery / Recyclable

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

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

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

IPX7

No harm for short time immersion

Type BF Applied Part

Transducer connector

Pencil Transducer connector (reserved)

ECG signal input connector (reserved)

Transducer lock

Transducer unlock

Network port

Trademark

Direct current

Video Output port

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Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction

USB 2.0 port

USB 3.0 port

Display port

Microphone input

Headphones

FCC ID:

SMQAX8EDAN

Federal Communication Commission: FCC ID: SMQAX8EDAN

NOTE:

The user manual is printed in black and white.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

2 Safety

Throughout this document the following terms are used:

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

or death.

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

inaccurate data, or invalidate a procedure.

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

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

2.1 Warnings

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

instructions prior to changing the battery.

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

shock or system malfunction.

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

ungrounded outlet.

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

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

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

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

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

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

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

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

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

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

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

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

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

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

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

simultaneously.

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

result in increased emissions or decreased immunity of the equipment.

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

including portable and RF communication devices.

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

system so that it is easy to disconnect the device.

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

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

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

patient. (1.5m/6ft.)

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

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

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

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

circuit being used to power the system.

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

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

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

guide assembly between uses.

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

report.

Transducer Warnings

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

passed.

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

new sterile sheath for each such procedure.

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

2.2 Cautions

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

not remove any covers.

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

use in a dusty environment.

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

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

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

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

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

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

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

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

 Practice ALARA principle when operating ultrasound system. Minimize the

acoustic power without compromising the image quality.

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

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

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

interference may cause image distortion or other malfunction.

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

months to ensure battery capacity.

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

professional for ultrasound evaluations.

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

system speaker or fans.

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

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

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

information.

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

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

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

part of an overall clinical assessment.

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Safety

source before cleaning and disinfecting.

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

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

Transducer Cautions

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

is evidence of excessive wear or damage.

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

transducer to temperatures in excess of 55°C .

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

with broken or bent pins.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

Printer Model

Printer Type

Interface

SONY UP-25MD

Color Image

S-Video

SONY UP-D25MD

Color Image

USB

SONY UP-X898MD

B/W Image

USB

HP Officejet Pro 251dw

Color Report

USB

HP Laserjet Pro 200 M251n

Color Report

USB

HP Laserjet CP1525n Color

Color Report

USB

HP Deskjet Ink Advantage 2010

Color Report

USB

HP Deskjet 1010 Color

Color Report

USB

HP Deskjet 1510 Color

Color Report

USB

HP LaserJet 400 M401d

B/W Report

USB

3 Getting Started

3.1 System Configuration

The Acclarix AX8 system is shipped with the following components:

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

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

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

L17-7SQ, C5-2MQ*

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

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

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

Note: Only support DVD disk single burning.

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

details.

Table 3-1 Printer List

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

Model

Name

Description

BGK-C5-2

BGK-C5-2 Needle Guide Bracket Kit

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

BGK-L40UB

L40UB Needle Guide Bracket Kit

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

BGK-CR10UA

CR10UA Needle Guide Bracket Kit

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

BGK-R15UB

R15UB Needle Guide Bracket Kit

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

BGK-P5-1X

BGK-P5-1X Needle Guide Bracket Kit

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

6 7

8 9

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

 Needle Guide Bracket Kit

Table 3-2 Needle Guide Bracket Kits

3.2 System Overview

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

No.

Name

Description

Monitor

Display the images and parameters during scanning.

Touch Screen

Use to control operation and activate functions

Control panel

Use to control the operation

Handle

Used for carrying the system

Hinge

Used to rotate the monitor

Transducer locking lever

Use to lock or unlock the transducer

Transducer Port

Used for connecting a transducer to the Acclarix AX8 main unit

TrackPad

Use to change the cursor position

Battery Indicator

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

I/O Ports

Use to connect the I/O extend modules

Figure 3-1 Appearance of the System

Table 3-3 Appearance of the System

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

1. Power supply

5. USB 2.0 port

2. S-Video output port

6. Network port

3. Display port

7. Microphone input port

4. USB 3.0 port

8. Audio output port

1 3 4

5 6 7 2 8

I/O Ports on the left panel:

Figure 3-2 I/O ports of the system

Table 3-4 I/O Ports of the System

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

3.3 Battery Use

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

CAUTION

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

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

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

to ensure battery capacity is more than 75%.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

To install the battery:

1. Turn off and unplug the Acclarix AX8 system.

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

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

automatically.

Figure 3-3 Installation of the Battery

To remove a battery:

1. Turn off and unplug the Acclarix AX8 system.

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

3. Slide the battery button to unlock the battery.

4. Take the battery out.

Figure 3-4 Battery Removal

To install the UPS battery:

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

2. Take out the UPS battery from the package.

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

Figure 3-5 Installation of the UPS Battery

3.4 Connecting and Disconnecting a Transducer

To connect a transducer:

Figure 3-6 Tansducer Locking Handle

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

2. Toggle the locking handle to the bottom position.

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

irreparable damage.

Figure 3-7 Lock the tansducer locking handle

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

To disconnect a transducer:

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

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

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

Figure 3-8 Unlock the Tansducer Locking Handle

CAUTION

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

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

with broken or bent pins.

Multi-Transducer Connector (MTC)

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

Figure 3-9 Connect to the MTC

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

off.

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

3.5 Powering on/ off

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

 To power on:

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

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

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

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

Note:

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

 To power off:

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

confirmation dialog box.

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

directly.

NOTE:

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

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

There are three events that can invoke sleep mode:

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

①

③

④

⑤

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

this time.

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

Figure 3-10 Confirmation Dialog Box When Power off

3.6 Screen Layout

Figure 3-11 Main Screen Display

①Information Field：

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

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

This field also contains data fields for:

 The currently active transducer

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

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

②Image Field:

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

③Mini Report:

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

④Thumbnail Field:

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

⑤Status Bar:

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

 Image Store icon

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

 Battery icon

: Battery fully charged, symbol in green.

: Battery higher than 80%.

: Battery 60%-80%.

: Battery 40%-60%.

: Battery low, symbol in red.

: Battery removed, outline in red.

: Battery charging.

 Network status icon

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

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

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

: Hard drive available

: Hard drive data exchange, symbol in green.

: Hard drive 95% full, symbol in red.

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

 USB icon

Symbol in grey color: USB available

 DVD icon

: Symbol in grey: DVD device is connected

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

transmission is available.  Printer icon

: Printer available.

 Wifi icon *

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

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

WARNING

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

1) this device may not cause harmful interference, and

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

No.

Key

Name

Description

Patient

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

cause undesired operation.

NOTE:

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

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

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

receiver is connected.

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

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

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

3.7 Control Panel

Figure 3-12 Control Panel of the System

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

Preset

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

End Exam

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

Utilities

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

Alt Store

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

Report

Press to display the report page

Review

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

Zoom

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

Depth

Press to adjust the depth of the image displayed.

10.

Body Mark

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

11.

Clear

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

12.

Comment

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

13.

Update

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

14.

Cursor

Press to hide or display the cursor

15.

Measure

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

16.

Freeze/Cine

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

17.

Store 1

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

18.

Store 2

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

19.

Gain

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

20.

User-defined button

21.

User-defined button

22.

Color

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

23.

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

24.

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

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

25.

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

Table 3-4 Buttons on Control Panel

3.8 Touch Screen

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

Figure 3-13 Touch screen of the System

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

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

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

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

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

that immediately performs an action (like “Auto”)

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

one will de-activate all others.

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

to access any of the controls in it.

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

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

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

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

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Acclarix AX8 Diagnostic Ultrasound System User Manual Getting Started

Customizing the touch screen

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

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

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

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

next page.

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

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

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

the B-mode tab.

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

 Comments  Bodymarkers  Measurements

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

3.9 Trackpad

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

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

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

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

For example:

o In most live imaging modes this is Gain.

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

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

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

box.

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

caliper pair.

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

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+ 101 hidden pages