82-01.54.002483-1.5 Acclarix AX8&AX7&AX4 Service Manual-ES PDF

EDAN Agile PLM Electronic Signature Information
--Signatures related to this document and performed in EDAN Agile PLM.
文件名称：Acclarix AX8&AX7 &AX4 维修手册_英文

文件编号：01.54.002483
版本：1.5
产品型号：Acclarix AX4;Acclarix AX7;Acclarix AX8
项目编码(Project Code)：2908G000
签批信息:
作者 : 谢菊艳 (xiejuyan) 2017-12-07 16:55:05
审核人 : 陈云飞 (chenyunfei) 2017-12-07 19:43:50
审核人 : 李娟 (lijuan) 2017-12-08 08:28:31
审核人 : 黄君君 (huangjunjun) 2017-12-07 19:22:32
审核人 : 郭欣 (guoxin) 2017-12-08 08:56:23
审核人 : 甘艳丽 (ganyanli) 2017-12-07 19:25:44
审核人 : 杨永龙 (yangyonglong) 2017-12-07 18:06:39
审核人 : 明镭 (minglei) 2017-12-08 08:19:01
批准人 : 陈卓鑫 (chenzhuoxin) 2017-12-08 15:02:45
批准人 : 冀伟 (jiwei) 2017-12-08 16:29:27
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

About this Manual
P/N: 01.54.002483
MPN: 01.54.002483015
Release Date: Dec., 2017
© Copyright EDAN INSTRUMENTS, INC. 2015-2017. All rights reserved.
This manual applies to Acclarix AX4\ Acclarix AX7\ Acclarix AX8.
The CE mark is invalidated for Acclarix AX7 until the product has been certified by notified
body.
Acclarix AX7 is not approved for sale until finishing the related registration.
Responsibility of the Manufacturer

EDAN is responsible for any effect on safety, reliability and performance of the equipment only
if:
 Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN.
 The electrical installation of the relevant room complies with local and national standards,
including IEC/EN 60601-1.
 The instrument is used in accordance with the instructions for use.
EDAN will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel to repair those parts
of the equipment that are designated by EDAN as repairable by service personnel.
Terms Used in this Manual

WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.
I
Table of Contents
1 Introduction ............................................................................................................................. 1
1.1. Warnings and Cautions ...................................................................................................... 1
1.2. Labeling Symbols .............................................................................................................. 4
2 Installation ............................................................................................................................... 7
2.1. General System Requirements ........................................................................................... 7
2.1.1 Environmental Requirements........................................................................................ 7
2.1.2 Power Requirements ..................................................................................................... 7
2.2. Unpacking .......................................................................................................................... 7
2.3. Installing Battery ................................................................................................................ 9
2.4. Configuring the System ................................................................................................... 11
2.5. Connection of Auxiliary Devices ..................................................................................... 11
2.5.1. Connecting the Report Printer..................................................................................... 12
2.5.2. Connecting the Video Printer ...................................................................................... 13
2.5.3. Connecting the S-Video Printer .................................................................................. 14
3 Functional Checks ................................................................................................................. 15
3.1. Transducer Connections ................................................................................................... 15
3.2. Battery Performance......................................................................................................... 15
3.3. System Response .............................................................................................................. 15
3.3.1 Transducer Detection/Selection .................................................................................. 15
3.3.2 USB Saving ................................................................................................................. 15
3.4. Transducer Frequency ...................................................................................................... 16
3.5. Transducer Depth ............................................................................................................. 16
3.6. Transducer Performance .................................................................................................. 17
3.7. General System Checks.................................................................................................... 17
4 Basic Service ......................................................................................................................... 18
4.1. Configuring Connectivity ................................................................................................ 18
4.1.1. TCP/IP......................................................................................................................... 18
4.1.2. DICOM ....................................................................................................................... 19
4.1.3. Network Store ............................................................................................................. 22
4.2. Performing an Upgrade .................................................................................................... 23
4.3. License and Configuration files ....................................................................................... 25
4.3.1 Configuration File ....................................................................................................... 26
4.3.2 Updating the License .................................................................................................. 27
4.4. Export/Import Presets....................................................................................................... 28
4.5. Exporting Log Files ......................................................................................................... 30
4.6. Remote Support................................................................................................................ 31
4.7. Preparing a System for Return ......................................................................................... 31
5 Advanced Service .................................................................................................................. 32
5.1. Removing the Ultrasound Module ................................................................................... 32
5.2. Removing and replacing the rear cover ........................................................................... 35
5.2.1 Removal Procedure: .................................................................................................... 35
II
5.2.2 Replacement Procedure: ............................................................................................. 37
5.3. Removing the Hard Disk .................................................................................................. 39
5.4. Replacement Parts ............................................................................................................ 45
5.5. Transducers ...................................................................................................................... 46
6 Troubleshooting..................................................................................................................... 48
6.1 Troubleshooting Notes ..................................................................................................... 48
6.2 System Does Not Boot ..................................................................................................... 48
6.3 Power on Self Test............................................................................................................ 48
6.3.1. Check If System Failure Is Caused by Ultrasound Module (USM) ............................................. 48
6.4 The System Boots, But No Image Appears ...................................................................... 48
6.5 USB Not Detected ............................................................................................................ 48
6.6 Noise or Artifact in the Image .......................................................................................... 49
6.6.1. Checking for Electromagnetic Interference ................................................................ 49
6.7 Troubleshooting the P5-1 flashlight issue ........................................................................ 50
6.7.1. Identifying the P5-1 issue............................................................................................ 50
6.7.2. Resolving the P5-1 flashlight issue ............................................................................. 51
6.8 System Password .............................................................................................................. 53
7 Care and Maintenance ........................................................................................................... 54
Appendix I: Service Record ........................................................................................................... 56
Appendix II Open Issues and Workarounds ................................................................................... 58
III
Acclarix AX8\ Acclarix AX7\ Acclarix AX4 Diagnostic Ultrasound System Service Manual Introduction
1 Introduction
The service provider must read and understand all the information presented in this manual and
indicated portions of the user manual before installing or servicing a unit.
Typical users of this manual:
 Service personnel (installation, maintenance, etc.)
 Hospital service personnel
 Distributors and contract service personnel
Note: Availability of some transducers and features is contingent on local registration and
regulatory approval. Please contact your local distributor or Edan representative for details.
Please see the User Manual for:
 Indications for Use
 Contraindications
 Device Description
 Full Warnings and Cautions applicable for clinical use.
1.1. Warnings and Cautions
The following Warnings and Cautions are intended for use while servicing the equipment.
Please see the user manual for Warnings and Cautions intended for clinical use.
WARNINGS:
 Only authorized personnel should perform service.
 Do not remove system covers or otherwise expose internal electronics. Field

serviceable components are limited to the ultrasound module, batteries, and
power cords.
 Use protective gloves while servicing equipment. Disinfect all cleanable surfaces
prior to servicing.
 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 a hospital grade, grounded, power outlet and plug. Do not use with an
ungrounded outlet. Only use a power outlet within the voltage range of the system
(see 2.1.2)
 The system is ordinary equipment (Sealed equipment without liquid proof). But the
console panel including touch screen, track pad and hard keys is IPX1. The
transducer (not including the connector) is IPX7. Do not immerse or expose any of
-1-
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
40℃. Don't 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/EN60601-1-1 medical electrical systems standard.
 Improper operation may cause the internal lithium battery (hereinafter called
battery) to be hot, ignited or exploded, and it may lead to a decrease of the battery
capacity. It is necessary to read the user manual carefully and pay more attention
to warning messages.
 To avoid the danger of introducing additional hazards, DO NOT perform any

unauthorized modification of the equipment.
 The power adapter is used to isolate the system from main power. Position the
system so that it is easy to disconnect the device.
Transducer Warnings
 Read and follow all manufacturer instructions for disinfection agents.
 To avoid infection, ensure that expiration date of the disinfecting solution has not
passed.
 Unplug the transducer from the system prior to cleaning or disinfecting.
 Do not immerse the transducer beyond the point indicated.
 Do not allow the transducer connector to get wet.
CAUTIONS:
 When replacing components such as the Ultrasound Module, avoid touching the
connector pins. Do not allow the connector pins to short.
 Use care when storing or disposing of batteries. Do not allow the leakage to come
in contact with skin. 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
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the recycling of waste batteries.
 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.
 Do not use in the presence of a flammable gas.
 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.
 During long term storage the battery should be charged at least once every 3
months to ensure battery capacity.
 Use only Edan supplied or recommended parts and accessories.
 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.
 Ensure that the system vents are clear and unobstructed.
 To avoid electrical shock, turn off and disconnect the device from the AC power
source before cleaning and disinfecting.
Transducer Cautions
 Do not use disinfection agents 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.
 Do not touch the pins of the transducer connector.
NOTE:
The pictures and interfaces in this manual are for reference only.
-3-
1.2. Labeling Symbols

The following labels are used on the system:
No. Symbol Definition
1 Serial Number
2 P/N Part Number
3 Date of Manufacture
4 Manufacturer
5 Operating instructions
Warning
6
(Background: Yellow; Symbol & outline: Black )
Refer to User Manual

7
(Background: Blue; Symbol: White)
8 Caution
9 Biological Risks
10 CE marking.
11 Authorized Representative in the European Community
Disposal method. Indicates that the equipment should be sent to

12 special agencies according to local regulations for separate
collection after its useful life.
13 General Symbol for Recovery / Recyclable
Caution: Federal (U.S.) law restricts this device to sale by or on

14
the order of a physician.
-4-
Conforms to AAMI Std. ES 60601-1, IEC Std. 60601-2-37

15
Certified to CSA Std. No. 60601-1, No 60601-2-37
16 IPX7 No harm for short time immersion
17 Type BF Applied Part
18 Transducer connector
19 Pencil Transducer connector (reserved)
20 ECG signal input connector (reserved)
21 Transducer lock
22 Transducer unlock
23 Network port
24 Trademark
25 Direct current
26 Video Output port
27 USB 2.0 port
28 USB 3.0 port
29 Display port
30 Microphone input
31 Headphones
-5-
32 Non-ionizing electromagnetic radiation
FCC
Federal Communications Commission:
33 ID:SMQAX8E
FCC ID:SMQAX8EDAN
DAN
NOTE: The manual is printed in black and white.
-6-
Acclarix AX8\ Acclarix AX7\ Acclarix AX4Diagnostic Ultrasound System Service Manual Installation
2 Installation
2.1. General System Requirements
2.1.1 Environmental Requirements
Condition Ambient Temperature Relative Humidity Atmospheric Pressure
0 °C ~ +40 °C 15% RH ~ 95% RH
Operation 860 hPa - 1060 hPa
(+32 °F~+104 °F) （no condensation）
-20 °C ~ +55 °C 15% RH ~ 95% RH
Transportation 700 hPa ~ 1060 hPa
(-4 °F~+131 °F) （no condensation）
-20 °C ~ +55 °C 15% RH ~ 95% RH
Storage 700 hPa ~ 1060 hPa
(-4 °F~+131 °F) （no condensation）
Table 2-1 Environmental Requirements
2.1.2 Power Requirements

Voltage Tolerances Input Current Frequency
2.5A(2.5A-1.5A) （AC adapter）
100 V-240 V~ ±10% 50 Hz/60 Hz
19V 7.8A MAX(DC)
Table 2-2 Power Requirements
2.2. Unpacking
Visually examine the package prior to unpacking. If any signs of mishandling or damage are
detected, contact the carrier to claim for damage.
Step 1. Remove or cut the packing tape from three sides of the sealed box.
Step 1
Step 2. The contents of the box are organized in three layers. The top layer contains the system
itself, in a protective plastic bag. Remove the system and set it on a clean flat surface.
-7-
Step 2
Step 3. The middle layer may contain transducers, depending on how the order was processed.
Transducer may have been shipped separately, in which case the middle layer is empty..
Step 3
Step 4. The bottom layer contains accessories, as indicated in the following figure:
Step 4
After unpacking is complete, check the contents against the packing slip to confirm the correct
contents. As each item is confirmed, inspect the item. Report any items that are missing, back
ordered or damaged to EDAN or authorized representatives.
-8-
2.3. Installing Battery

The 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 has remained 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%.
To install the battery:
1. Turn off and unplug the ultrasound system.
2. Close the monitor, turn the system upside down and rest it on a flat stable surface.
3. Insert the battery gently into battery compartment and the buttons will lock the battery
automatically.
Figure 2-1 Installation of the Battery

To remove a battery:
1. Turn off and unplug the ultrasound system.
2. Close the monitor, turn the system upside down and rest it on a flat stable surface.
3. Slide the battery buttons to unlock the battery.
4. Take the battery out.
-9-
Figure 2-2 Uninstallation of the Battery

The system also includes a UPS battery that supplies a trickle charge when the main battery is
unavailable. That trickle charge is insufficient to fully power the system.
To install the UPS battery:
1. Close the monitor, turn the system upside down and rest it on a flat surface.
2. Take out the UPS battery from the package.
3. Put the UPS battery gently to the UPS battery compartment.
Figure 2-3 Installation of the UPS Battery

Note:
Please remove the lithium-ion battery prior to installing the UPS battery.
- 10 -
2.4. Configuring the System

After you upgrade the software from 1.3X release to 1.4X release for AX8 and AX7 systems, the
first time you power on the system, a dialog as shown below will be displayed, allowing you
select the correct market area and product model for this system. The selected market area and
product model together determine the configuration of your ultrasound systems.
If you skipped this operation when powering on the system for the first time, next time you power
on the system, this dialog window will be displayed again.
To change the market area and product model after configuring the system, do the follows:
1. Connect a USB keyboard and mouse to the system.
2. Press Ctrl+Shift+M and enter the service password to access the OS manager dialog. Contact
Edan Service if you do not know the service password.
3. Once the OS manager dialog is displayed, the Utility page will have a “Area and Model”
button. Pressing this button will display the Area and Model selection dialog again.
4. Select the correct market area and product model for this system.
2.5. Connection of Auxiliary Devices
Figure 2-4 Connection of Peripherals
- 11 -
2.5.1. Connecting the Report Printer

1. Connect one Report Printer with the ultrasound system via the USB cable.
2. Press Utilities key on the console, click Set Up button on the touch screen and then use
the trackpad to open the Store/Print setup page, as shown below:
3. Press Add to add this printer to the system, and its printer model will be displayed in
Printers list.
4. Press Test to test whether the printer is connected successfully. A test page being printed
out indicates that this printer is connected successfully.
Note:
1. The Printers list can display up to six printers added to the system recently. If
one of the six printers is connected to the system again, you can print directly
without adding it again.
2. The ultrasound system is configured with pdd files of most of the popular
printers and you can add those printers directly. If the ultrasound system does
not have your printer's pdd file configured inside, when you add this printer, the
system will prompt you no ppd file. In that case, you may need to download the
ppd file from the printer supplier. Put the pdd file to a USB stick inside a
directory named “ppd”. Connect the USB disk along with the printer to the
ultrasound system and then do the adding again.
- 12 -
2.5.2. Connecting the Video Printer

1. Connect one supported Video Printer with the ultrasound system via the USB cable.
2. Press Utilities hard key on the console, press Set Up soft key on the touch screen and then
use the trackpad to open the Store/Print setup page, as shown below:
3. Click the down arrow in the Store 1, Store 2 or All Store field and select the connected
Video Printer model from the list.
4. Save the settings. Press the Store 1, Store 2 or All Store key correspondingly to perform
the image printing.
- 13 -
2.5.3. Connecting the S-Video Printer

1. Connect one supported S-Video Printer with the ultrasound system via the video cable.
2. Press Utilities hard key on the console and press Set Up soft key on the touch screen to
open the General setup page, as shown below:
3. Select the same Video Mode (PAL or NTSC) as that of the S-Video Printer. The video
mode of the S-Video Printer can be toggled by the format adjusting key on its rear panel.
4. Save the settings.
5. After connection, press the CAPTURE key and then PRINT key on the printer to perform
the image printing.
Note:
The image printing can be performed only when the video mode of the S-Video
Printer and the ultrasound system are the same. Switch off the printer and reselect
the Video Mode in General setup page if the video mode is changed on the printer,
and then restart the printer.
- 14 -
Acclarix AX8\ Acclarix AX7\ Acclarix AX4 Diagnostic Ultrasound System Service Manual Functional Checks
3 Functional Checks
The following steps confirm basic system functionality. They should be performed:
 After installation.
 After an upgrade or other significant service.
 Semi-annually.
If any of these functional checks fail, please contact EDAN Service for further instructions.
3.1. Transducer Connections

The system is designed to work with a transducer connected, and some features are unavailable
without a transducer. When possible, EDAN recommends that all functional tests are performed
with a transducer attached.
Connect a transducer on the right-hand site port of the ultrasound main unit and press down the
locker to lock the transducer, then power up the system.
Figure 3-1 Transducer Connection
3.2. Battery Performance

Confirm that the battery is working correctly:
 Make sure the battery is installed.
 Disconnect the AC power and confirm that the system remains powered up.
 Reconnect AC power and confirm that the battery is charging. The icon indicates
that the battery is charging.
3.3. System Response

Check if the ultrasound system is error-free when responding to user input (Press any key on the
control panel).
3.3.1 Transducer Detection/Selection
Check if the ultrasound system is error-free when auto-detecting connected transducer(s) or when
toggling operation between multiple connected transducers.
NOTE:
Perform test for all equipped transducers on each port if the system is equipped with an
MTC.
3.3.2 USB Saving
Check the ultrasound system is error-free when saving images/presets to an external USB
memory stick. Refer to chapter 4.4 Export/Import Presets.
- 15 -
3.4. Transducer Frequency

Press Freq. soft key on 10 inch touch screen control panel under B mode to adjust imaging
system to the different transducer operating frequencies.
Figure 3-2 10 inch touch screen control panel

Check if the transducer(s) is error-free in generating an imaging field in each of its intended multi
operating frequencies.
NOTE:
Perform test for all equipped transducers.
3.5. Transducer Depth

Press the Depth Hard key on the control panel to adjust imaging depth limit, check if the
ultrasound system is error-free when adjusting to different imaging depth.
Figure 3-3 Hard key control panel
- 16 -
3.6. Transducer Performance

Place a finger on the surface of the transducer and move it back and forth across the surface.
Observe the image on the screen and confirm that the finger movement can be seen. If in doubt,
use a little transducer gel to ensure good contact.
The image of the finger should be seen at each point along the surface. If there is a break in the
image at a specific spot it may indicate that the transducer has a bad element. If this is suspected,
capture a clip showing the movement and send it to EDAN Service for confirmation.
NOTE:
Perform test for all equipped transducers.
3.7. General System Checks

Step Item Description
Inspect the transducer to make sure that there is no damage.

1. Transducer and cables Inspect cables, do not use a cable which is frayed or split, or
shows signs of wear
2. AC adapter Inspect the AC adapter to make sure that there is no damage.
3. Control panel Check that the control panel is clean.
Check that the screen and indicators are normal, date/time

displayed on the screen is accurate and no error message
displayed.
Check transducer model and frequencies are accurate.
Check obvious abnormal noise, discontinuous image or dark

area in B mode image.
4. Power up Check unusual smell or over heat
Check the transducer surface to avoid over heat.
Perform all functional tests to verify that the control panel,

touch screen and touchpad are OK.
Check the loudspeaker to avoid abnormal noise
Check the fan to make sure no abnormal noise
- 17 -
Acclarix AX8\ Acclarix AX7\ Acclarix AX4 Diagnostic Ultrasound System Service Manual Basic Service
4 Basic Service
4.1. Configuring Connectivity
The Connectivity screens support configuration of network access and services. It is divided into
3 tabs:
 TCP/IP: Configures access to the network from the ultrasound system.
 DICOM: Configures network DICOM services.
 Network Store: Configures non-DICOM storage to a network via FTP.
4.1.1. TCP/IP
This screen configures access to a network. Access can be either wired or wireless.
Figure 4-1 TCP/IP Set-up Screen

Wired Settings:
The following settings apply when connecting an ultrasound system to a wired network via the
network port on the side of the system.
Get Local IP: Either Manually entered (Static) or DHCP. The correct setting will depend on
how your DICOM network is administrated. If you are unsure, try DHCP first. Generally a
Static IP is only needed if the target PACS system requires it. If it is needed, contact your
network IT manager.
IP Address, Subnet Mask, Gateway, DNS: These settings determine how the ultrasound
system communicates with your network. If you chose DHCP then your network router
will set these automatically. If you chose Manually Entered IP then contact your network
IT manager for the appropriate settings.
- 18 -
Wireless Settings: (note: availability of this feature will depend on local regulatory status)
Enable Wireless: This will turn the wireless radio on/off. No wireless networks are
displayed when this is disabled.
Networks: When wireless is enabled the system will search for wireless networks that are
available and display them in this list. Networks that have been previously accessed will
show up with a checkmark (“*”). If there is currently an active network it will show up
with an asterisk (‘√’). If the network requires a password it shows up with a lock icon.
Each displayed network shows the strength of the wireless signal.
Refresh: Clicking on this button updates the list of displayed networks.
The following controls require that a wireless network has been selected from the network
list. Click on the name of a network to select it.
Join: This joins the selected network. If a password is needed a dialog box will be
displayed to enter it.
Forget Network: This forgets any password of the selected network that had been entered,
but the network is still shown in the list.
Advanced Settings: This brings up a dialog box with additional settings for the selected
wireless network. The dialog box includes the following:
 Password: This is useful when the network password has changed.
 Method: Either Manually entered (Static) or DHCP. Generally wireless networks
use DHCP, and a Static address is only needed if required by the target PACS system.
 IP Address, Subnet Mask, Gateway, DNS: If you chose DHCP then your network
router will set these automatically. If you chose Manually Entered IP then contact
your network IT manager for the appropriate settings.
4.1.2. DICOM
This screen configures DICOM services, including Store and Modality Worklist.
Local Settings:
These settings determine how the ultrasound system communicates with other DICOM devices.
These are required for both Store and for Modality Worklist.
- 19 -
Figure 4-2 DICOM Set-up Screen

Local AE Title: Any 16 characters that uniquely identify this system on your DICOM
network. The default “EDAN_STR_SCU” will work unless you have multiple Edan
systems on your network.
Time Out, Transfer Syntax: These determine how the DICOM messages are configured.
The ultrasound system default settings are common, and you will typically not have to
change them. If Ping works, but Verify does not, you may need to review the conformance
statement of your server to determine the proper settings for these.
DICOM Store: Determines when DICOM images and clips are sent to the server. The
options are:
 Transfer on demand: Images, clips and structured reports are only sent when you
manually send them. When there is no exam in progress the Review hard key will
show a list of all exams on the hard drive. Select an exam and press the Send button
at the bottom of the screen.
 Auto-Transfer when Store: Each image or clip is sent automatically when it is
captured. This has the advantage that images and clips are immediately available
for review at the server while the exam is in progress. It has the disadvantage that,
due to the nature of DICOM, images that are already sent can not be deleted from the
server from the ultrasound system.
 Auto Transfer when End Exam: Images, clips and structured reports are sent
automatically when the exam is ended. This is the most common setting.
Monitor Network: Check this item to monitor DICOM network connection status and
update the status of DICOM network icon accordingly during DICOM transfer.
SR Configuration: This brings up a dialog box for detailed structured report configuration.
The dialog box includes the following:
 Send SR with Images: This will enable the function of sending structured report
together with images to a DICOM server.
- 20 -
 Report Type: this determines the type of structured report. Select Enhanced report or
Comprehensive report according to the report type your PACS system requires.
 Data Configuration: this determines whether a report with All results or with only
Summary Results will be sent. All results include all the individual measurement
results of each measurement and its summary results in the worksheet, while
summary results come from all the individual measurement results by the method of
average, maximum, minimum or last which is decided by the user in the worksheet.
 Sequence Delimiter: this determines the method to indicate the end of a DICOM
sequence. Undefined and Explicit are available.
Server Settings:
Server list: The main interaction in this section is a list of configured servers. It starts off
as an empty list, and grows as servers are added. Most sites will only use one server, but if
the system is moved between locations then multiple servers may be entered. Clicking in any
field in this list will select that server. Depending on the exact level of software a second
click may be needed to edit that field. The fields are:
 Default: A check mark on the left side indicates which server is the default for
Auto-Transfer.
 Name: The name of the server that appears in the drop-down list of the patient
database
 AE Title, IP Address, Port, Max PDU: These are the settings of the destination
DICOM server; it’s how the system finds the DICOM server on your network. The
AE title and IP Address are unique to your network; contact your network IT
manager for these settings. The most common setting of Remote Port for DICOM
servers is 104, although your server may be different.
Testing the server: There are two tests to ensure that the server information is entered
correctly. Click on any field for a given server to make that server selected, then:
 Ping: A successful Ping means that the system can communicate with the server at a
low-level; basically that the two computers ‘see’ each other. As a security measure,
some servers on the Internet may be configured to not respond to a Ping even if the
connection is successful.
 Verify: A successful Verify means that the system can communicate with the server
at a DICOM level; basically that the DICOM on both computers understand each
other. A successful Verify will typically mean that your DICOM configuration is
correct.
Other controls:
 Add: Adds another line in the list of servers.
 Delete: Deletes the selected server.
 Default: Makes the selected server the default for Auto-transfer.
- 21 -
Modality Worklist: Modality Worklist will query the configured server for a list of all ultrasound
exams scheduled within the configured date range.
Enable: Turns Modality Worklist on/off.
Update Worklist: Determines when the worklist is updated. Choices are:
 On Demand: Updates only when the Update button is pressed from the patient page.
 Every 15 Minutes: Updates on power-up and then regularly every 15 minutes.
 Every hour: Updates on power-up and then regularly every hour.
 On Start of Exam: Updates when the patient page is displayed at the start of each
exam.
Comment Source: Modality Worklist can fill the ultrasound comments section from the
server. Depending on
 Patient Comments: Obtains comments from DICOM tag (0x0010,0x4000);
 Scheduled Procedure Description: Obtains comments from DICOM tag
(0x0040,0x0007)
 Comments on Schedule Procedure: Obtains comments from DICOM tag
(0x0040,0x0400)
Worklist Server: Selects the server to query for the worklist. Options include any server
configured in Server Settings (see previous section).
Date Range: The range of dates for the worklist query. Note, the option of “Yesterday and
Tomorrow” includes today’s exams.
Map SPSD: Checking this item, the Study Description on Patient information page will
show study description and as well as SPSD(Scheduled Procedure Steps Description)
obtained from Worklist server. Otherwise only shows the study description
4.1.3. Network Store
This screen configures the system to connect to an FTP server on the local network. This allows
the system to store .avi and .bmp files to a local server without using DICOM. To use this, a PC
or server needs to be configured as an FTP server on the local network. The mechanism to do
this depends on the operating system used. Please contact your local IT support for assistance.
Once configured, studies can be sent to the FTP server from the Exam Database shown in Review.
Studies are sent to the configured folder, where each study appears in a separate folder with the
name of the patient and the study date.
- 22 -
Figure 4-3 Network Store Set-up Screen

FTP Server list: The main interaction in this section is a list of configured servers and
directories. It starts off as an empty list, and grows as servers are added. Most sites will
only use one, but if the system is moved between locations then multiple entries may be
useful. Clicking in any field in this list will select that server.
 Name: The name of the server that appears in the drop-down list of the patient
database
 IP Address, Shared Directory: These are the address of the FTP server and the
directory used on that server.
Testing the server: There are two tests to ensure that the server information is entered
correctly. Click on any field for a given server to make that server selected, then:
 Ping: A successful Ping means that the system can communicate with the FTP server
at a low-level; basically that the two computers ‘see’ each other. As a security
measure, some servers on the Internet may be configured to not respond to a Ping
even if the connection is successful.
 Connect: A successful Connect means that the system can communicate with the
FTP server, and FTP transfers will work. If this fails but Ping works it could mean:
oThe destination computer is not correctly configured as an FTP server.
oThe password on the server has changed. Use Edit to re-enter the password.
oThe Shared Directory does not exist. Use Edit to confirm the directory.
Add: Adds another line in the list of servers. This automatically invokes Edit.
Edit: Available when an FTP Server has been selected. This invokes a dialog that edits the IP
address, name, directory, and password.
Delete: Available when an FTP Server has been selected. This deletes the selected server.
4.2. Performing an Upgrade

The details of performing an upgrade may vary depending on the upgrade. The following
instructions apply to a standard upgrade of software and firmware. If additional steps are needed
for a specific upgrade they will be provided separately.
- 23 -
Preparing for the upgrade

EDAN upgrades are done using an ‘epk’ package and its corresponding "md5sum" file. The
"epk" package combines all needed software and firmware, and the "md5sum" file is used to
verify the "epk" package is packaged correctly.
When an upgrade is needed the EDAN Service team will contact you regarding the details and
how to get the needed upgrade file. If you are sent a USB stick you can skip to ‘Performing the
upgrade’. If you were sent an electronic file you will need to copy that file to a USB stick. EDAN
recommends that you use a new USB stick, or a memory stick dedicated to EDAN upgrades.
Mount the USB stick on your computer. On the top level of the USB stick create a folder named
“Ultra”. Within that folder create another folder named “upgrade”. Copy the epk package and
md5sum file to Ultra/upgrade.
Note:
 The epk package and md5sum file you receive from EDAN may not be named ‘upgrade.epk’
and ‘upgrade.md5sum’. In that case rename it to ‘upgrade.epk’ and ‘upgrade.md5sum’.
 The "md5sum" file is created when the "epk" package is packaged. Each "epk" package has
its own "md5sum" file, please don't use the "md5sum" file with other epk packages.
Performing the upgrade
 Power up the ultrasound system that is to be upgraded, and insert the USB stick
containing the upgrade.
 Press the Utilities hard key, and then the Maintenance button on the touch screen.
 Click on the Version tab at the top of the screen. The screen should look similar to figure
4-4.
Note: If you do not see an arrow cursor on the screen, press the Cursor hard key
on the console to invoke one.
Figure 4-4 Version display from Maintenance function
- 24 -
 Click on the Upgrade button at the lower left of the screen. A dialog box will be
displayed asking for confirmation. Click the ‘Yes’ button.
 After a few seconds the screen should look similar to figure 4-5. Each line in the dialog
corresponds to a component that will be upgraded. The number of lines displayed will
depend on the upgrade.
 Click the Start button. Each component will start to upgrade one by one, with the
corresponding line turning green when it is complete.
Note:
The update may last several minutes, do not operate the system or interrupt the
power supply during the update process.
 Upon completion the system needs to shut down to complete the upgrade.
Figure 4-5 The Upgrade Dialog
4.3. License and Configuration files

The features and capabilities of a given ultrasound system depend on the following:
 System type: Currently there are two different types: for human use and for veterinary
use. The system type is set at the time of manufacture and should not be changed in the
field.
Caution: Attempting to change the system type in the field is not a supported operation.
Attempting to do so may cause the system to behave incorrectly.
 Configuration file: The configuration file determines what features are allowed on a
given configuration of system, given local regulatory restrictions. If a feature is disabled
by the configuration file it generally means that feature is not available in a given market.
Caution: Do not load a configuration file that has not been approved for the local market
and system type.
 License file: The license file determines which features are enabled on each specific
system. Generally, license files are specific for a particular system.
- 25 -
4.3.1 Configuration File

New systems coming from the factory have correct configuration files. There are two situations
when a configuration file may need to be updated:
 An upgrade to a new release.
 A regulatory approval for the current configuration. For example, an FDA or CFDA
approval may allow us to enable features are latent in the system but disabled by
configuration.
In either case, specific instructions will be provided with the updated configuration file.
Loading a New Configuration File
 Press the Utilities hard key, and then the Maintenance button on the touchscreen.
 Click on the Version tab at the top of the screen. The screen should look similar to figure
4-6.
 Insert a USB containing the updated configuration file. The configuration file should be
in a ‘config’ folder within the ‘Ultra’ folder on the USB stick.
 Click on the “Import Config” button on the Version screen. (See highlight in 4-6), and
then confirm that you want to overwrite the current configuration.
 The system will display the path/name of a configuration file from Ultra/config. If there
are multiple config files you can select the correct one for the current system.
Caution: Do not load a configuration file that has not been approved for the local market and
system type.
Figure 4-6 Import Config screen
- 26 -
Checking the Current Configuration File

To check the current configuration of a system:
 Press the Utilities hard key, and then the Maintenance button on the touchscreen.
 Click on the Version tab at the top of the screen.
 Click on the “Show Config” button on the Version screen. (See figure 4-7).
 The system will display which features are enabled/disabled in the current configuration.
Figure 4-7 Example of Current Configuration dialog
4.3.2 Updating the License

The ultrasound system is shipped from the factory with all configured features already enabled.
On an upgrade, or if the customer decides to purchase additional features you may need to install
a new license file to upgrade the system.
Obtaining a New License File
Each license file is tied to a specific system. The software serial number or 2D Code of the
system will be needed in order for EDAN to generate a new license file.
 Press the Utilities hard key, and then the Maintenance button on the touch screen.
 Click on the License tab at the top of the screen. The screen should look similar to figure
4-8.
Note:
If you do not see an arrow cursor on the screen, press the Cursor hard key on the
console to invoke one.
- 27 -
 The SW serial number is the 32-character string at the top of the list of licensed features.
The 2D code is next to it. Either write down the string or take a picture of the screen
(preferred) and send this to EDAN Service.
Figure 4-8 The License Screen

Importing a New License File
Once an updated license file is provided to you, the next step is to import that into the system.
 On a USB stick create a folder named ‘Ultra’. Within that folder create another folder
named ‘license’. Copy the license file to Ultra/license/license.
 Power up the ultrasound system and put the USB stick into one of the USB ports.
 Press the Utilities hard key, then the Maintenance button on the touch screen.
 The License tab should be highlighted by default at the top of the screen. If it is not
highlighted, click on it to highlight it.
NOTE
If you don’t see an arrow cursor on the screen, press the Cursor hard key on the
console.
 Click the Import button on the lower left of the screen. You will see a couple of dialog
boxes asking you to confirm that you want to update the license and confirming the
location of the license file. Click ‘Yes’ and ‘OK’
 The license file will update. All available features will have a check mark next to them.
4.4. Export/Import Presets

The system has extensive customization options. These can be moved from system to system to
ensure consistent behavior across systems. Once one system has been configured correctly follow
the following steps:
- 28 -
Exporting Presets
 Insert a USB stick into one of the USB ports.
 Click on the Export/Import tab to highlight it. The screen should look similar to figure
4-9.
NOTE:
console.
 Check to make sure the Export radio button is active (it should be the default)
 Click the checkbox next to the items to be exported: Image Presets, Comment Presets,
Body Mark Presets, User Settings, System Log and Findings.
o Each type of preset can be expanded using the arrow graphics on the left side. This
allows you to export/import any subset of any type of preset.
o The Select All control at the bottom of the screen can be used to quickly toggle on or
off all of the checkboxes.
 The User Settings includes all system-wide settings. It also contains the links between
layers of presets. For example, suppose a system has a user-created comment preset that
was named ‘my_ABD_comments’ that was linked to the Abdomen exam preset on that
system. Exporting those presets and then importing them to a different system would not
link ‘my_ABD_comments’ to the Abdomen exam preset on the new system, unless the
User Settings were also exported/imported.
 Click the Export button at the bottom of the screen to begin the export process.
Figure 4-9 The Import/Export Screen
- 29 -
Importing Presets
4-9.
NOTE:
console.
 Click on the Import radio button at the top of the screen.
 Click the checkbox next to the items to be imported: Image Presets, Comment Presets,
Body Mark Presets, User Settings and Findings.
o Each type of preset can be expanded using the arrow graphics on the left side. This
allows you to export/import any subset of any type of preset.
o The Select All control at the bottom of the screen can be used to quickly toggle on or
off all of the checkboxes.
 Click on the Import button at the bottom of the screen. A confirmation dialog will appear.
Click ‘Yes’ to confirm overwriting the current system presets.
4.5. Exporting Log Files

From time to time you may be asked to provide log files to EDAN as we try to diagnose a
customer issue. To do so:
4-9.
NOTE:
console.
 Check to make sure the Export radio button is active (it should be the default)
 Ensure that only the System Log option is selected from the checkboxes showing what
will be exported. Deselect all other options.
 Click the Export button at the bottom of the screen to begin the export process.
 Bring the USB stick over to your computer.
The log files will be in Ultra Settings/SystemLogs/syslog_yyyymmddhhmmss, where the
latter part of the file name is the timestamp of the export time.
- 30 -
4.6. Remote Support

Remote support function is intended to provide training and service support for customers by
using a Bomgar branded remote control software installed on PC. It is only available when it is
activated by license or configuration file.
Operations can be conducted through remote support function are listed as follows:
 See all screens of the ultrasound system.
 Do all GUI operations .
 Download files, such as .epk upgrade file, license and configuration file, to the ultrasound
system.
 Upgrade software, update license and load a new configuration file remotely.
 Upload files, such as presets, system logs and findings, from the ultrasound system.
Contact EDAN Service for the instructions for using Remote Support function.
4.7. Preparing a System for Return

If you are asked to return a system:
 When appropriate, make arrangements for a loaner system to be used by the customer
while their system is being serviced.
 If there will be a loaner, export the presets from the original system so they can be later
imported on the loaner system.
 Export a copy of all Exam information from the Review function and provide that copy to
the customer. See section 7.4.3 of the basic user manual for details.
 Discuss with the customer whether patient data should be deleted from the system. EDAN
service technicians have been trained in patient privacy standards such as HIPAA, but
privacy policies and procedures may vary from site to site. If the patient data is to be
deleted, see section 7.4.3 of the basic user manual for details.
 Clean all surfaces of the system. See section 12.4 of the basic user manual for details.
 Pack the system in the original box and packing material by reversing the steps outlined in
section 2.2 of this manual
- 31 -
Acclarix AX8\ Acclarix AX7\ Acclarix AX4 Diagnostic Ultrasound System Service Manual Advanced Service
5 Advanced Service
CAUTION:
This section describes advanced service steps that should only be done by, or under the
direction of, EDAN Service Engineers. Other use of this section may void the warranty.
5.1. Removing the Ultrasound Module

Before disassembling the unit, please make sure that:
 The power supply has been disconnected;
 The battery has been removed;
 Transducers and any external components have been removed.
WARNING
Observe precautions for handing electrostatic discharge sensitive devices. Wear
ESD-preventive wrist straps or gloves when disassembling boards.
Tools: Phillips screwdriver, tweezers
Removal Procedure:
Step 1. Close the monitor, turn the system upside down and rest it on a flat surface. Use
tweezers to remove the ultrasound module fastener cover on the rear cover. Remove the
rubber plugs over the two screws on the right of rear cover. .
- 32 -
Ultrasound module
fastener cover
Hole plugs
Step 1
Step 2. Unscrew the three M3*6 flat head screws on the rear cover of the system, shown as the
following figure:
Screw position
Step 2
Step 3. Loosen the fastener, and pull out the ultrasound module from the right side of the
system.
- 33 -
Step 3
Figure 5-1 Ultrasound Module

Installation procedure:
Step 1. Insert the ultrasound module into the slot on the right side of the system.
Step 1
- 34 -
Step 2. Fix the ultrasound module with the three M3*6 flat head screws.
Screw position
Step 2
Step 3. Cover the Ultrasound module fastener cover on the rear cover, use tweezers to mount the
two hole plugs on the right of rear cover, install the battery, and then overturn the system
and put it on a flat table.
5.2. Removing and replacing the rear cover

5.2.1 Removal Procedure:
NOTE:
Three different screw types are used to fasten the back cover. These different types can
look similar to each other. Ensure that these are kept separate.
Step 1. Slide the battery locking lever inwards to unlock the battery, and take the battery out.
Step 1
- 35 -
Step 2. Turn the system upside down and rest it on a flat stable surface, and remove the rubber
plugs over four screws.
Step 2
Step 3. Use a pair of tweezers to remove the ultrasound module fastener cover on the rear cover,
and remove the cover.
Step 3
Step 4. Use the Phillips screwdriver to unscrew all screws on the rear of the system, as show in
the following figure. Note that there are three types of screws. Ensure that these are kept
separate.
- 36 -
M3*8 Flat head screw
Screw position
Other screws on
the rear cover:
M3*6 flat head
M2.5*7 screw
Flat head screw
Step 4
5.2.2 Replacement Procedure:

Step 1. Mount the rear cover.
Step 1
Step 2. Screw in the rear cover of the system with the Phillips screwdriver, and screw positions
are as shown in the following figure.
- 37 -
M3*8 Flat head screw
Screw position
Other screws on
the rear cover:
M3*6 flat head
M2.5*7 screw
Flat head screw
Step 2
Step 3. Mount the ultrasound module fastener cover.
Step 3
Step 4. Mount the rubber plugs back over the four screws.
- 38 -
Step 4
Step 5. Mount the battery.
Step 5
5.3. Removing the Hard Disk

Step 1. Remove the rear cover as described in the previous section.
Step 2. Use the Phillips screwdriver to unscrew the two M2.5*7 flat head screws, which fix the
hard disk, unplug the SATA cable and power supply cable, and take out the hard disk, as
shown in the figure below.
- 39 -
Step 2
Figure 5-2 Hard Disk Module

Step 3. Tear the copper foil away from the margins of hard disk.
Step 3
Step 4. Tear the Mylar away from the hard disk.
Step 4
- 40 -
Figure 5-3 Hard Disk Module without Copper Foil and Mylar
Step 5. Use the Phillips screwdriver to unscrew the four M2.5*7 flat head screws, which fix the
metal bracket, and take out the hard disk.
Screw positions
Step 5
Figure 5-4 Hard Disk
- 41 -
Installation procedure:
Step 1. Mount the hard disk onto the bracket, and fix it with four M2.5*7 flat head screws.
Screw position
Step 1
Step 2. Tear the release paper away from the Mylar, and stick the Mylar to the hard disk, as
shown in the following figure.
Step2
- 42 -
Figure 5-5 Hard Disk Stuck with Mylar

Step 3. Tear the release paper away from a new copper foil(no need to take out the release paper
totally at first), stick it to the Mylar and bracket, and then take out the release paper
totally, and keep the copper foil flat, as shown in the following figure.
Step 3
- 43 -
Figure 5-6 Hard Disk Stuck with Copper Foil

Step 4. Insert one end of SATA cable and power supply cable into the hard disk, and another end
into the main board, mount the hard disk onto the system and fix it with two M2.5*7 flat
head screws.
SATA cable
and power
supply cable Screw position
Step 4
Step 5. Replace the rear cover as described in the previous section.
- 44 -
5.4. Replacement Parts

No. Part Description Part Number Picture
1. Power Cable (EUR standard) 01.13.036638
2. Power Cable (USA standard) 01.13.037122
3. Power Cable (Brazil standard) 01.12.036750
4. AC Power Adapter 21.21.064243
5. Lithium Battery 21.21.064246
02.01.211425/
6. Ultrasound Module 02.01.214045
(for Acclarix AX4 )
Table 5-1 Replacement parts
- 45 -
5.5. Transducers
Model Part Number Type Illustration
C5-2XQ 02.01.211389 Convex
C5-2Q 02.01.212622 Convex
L10-4Q 02.01.211390 Linear
L17-7HQ 02.01.211393 Linear
L17-7SQ 02.01.211394 Linear
E8-4Q 02.01.211392 Endocavity
P5-1XQ 02.01.211391 Phased

Array
- 46 -
P5-1Q 02.01.213916 Phased

Array
L12-5Q 02.01.212623 Linear
MC8-4Q 02.01.212625 Micro

Convex
C5-2MQ 02.01.211474 Convex
P7-3Q 02.01.214038 Phased

Array
MC9-3TQ 02.01.213995 Micro

Convex
Table 5-2 Transducers

NOTE:
This list is based on the maximum configuration and therefore some transducers may not
apply to your product.
- 47 -
Acclarix AX8\ Acclarix AX7\ Acclarix AX4 Diagnostic Ultrasound System Service Manual Troubleshooting
6 Troubleshooting
Please read and understand all cautions and warnings prior to servicing. See section 1.1 for
details.
6.1 Troubleshooting Notes

 When evaluating image quality, best results are seen in a low ambient light environment.
 Clean the screen with a lint-free cloth prior to image evaluation.
 If troubleshooting involves cycling power, please wait 5 seconds between powering-off
and powering-on.
 All electronic equipment, including the system, can be susceptible to electromagnetic
noise and interference. Please see section 6.6.1 for details.
 Ensure that all system use and service are done within the environmental limits of the
system. See section 2.1 for details.
6.2 System Does Not Boot

 If the system is not plugged in, the battery may be fully discharged. Plug the system into a
hospital grade, grounded plug.
 Check the connections from the plug to the power supply, and from the power supply to
the system. Reseat these connections firmly.
 Check that the plug is getting power by plugging in any device that is known to work.
Try using a different circuit.
 Firmly press the power button and hold it in for about a second.
 Are the console keys lit?
o If so, proceed to section 6.3.
o If not, replace the power adaptor and try again.
6.3 Power on Self Test

6.3.1. Check If System Failure Is Caused by Ultrasound Module (USM)
If “USM Failed” is displayed on the monitor after the system boots up, check if the USM breaks
loose, if it is connected properly, or if the location column at the connector which connects the
ultrasound module is broken. Disconnect the USM and reconnect it as described in section 5.1.
6.4 The System Boots, But No Image Appears

 Inspect the connectors on the transducer and on the system. Ensure the connectors are
clean, dry, and have no bent or missing pins.
 Check that the transducer is fully plugged in.
o Try a different transducer to determine if the issue is with the system or the
transducer.
 Swap the Ultrasound Module (See section 5.1)
6.5 USB Not Detected

If a USB memory stick is inserted but not detected, try the following:
- 48 -
 The operating system may take up to 10 seconds to detect a USB memory stick. Make
sure the device is fully seated for at least that long.
Caution:
Do not insert/remove a memory stick repeatedly. Doing so may interfere with the
ability of the system to detect the memory stick, and require a re-boot.
 If the system is in a GUI screen, return to the live image and try removing and re-inserting
the USB. Check to see if the USB icon appears at the bottom of the main screen.
 If a reboot is required, remove the USB memory stick prior to rebooting, and don’t
re-insert it until the reboot is complete.
6.6 Noise or Artifact in the Image

 Check for electromagnetic interference. See section 6.6.1 for details
 Dark image: Adjust Gain, or press the Auto key in B-mode.
 Dark shadow in one part of the screen. Check that sufficient coupling gel has been used.
Try a different transducer. Inspect the transducer for defects on the transducer lens or on
the connector.
 Recall a factory default preset to ensure that image parameters are set correctly.
6.6.1. Checking for Electromagnetic Interference
Ultrasound machines are susceptible to Electromagnetic Interference (EMI) from radio
frequencies, magnetic fields, and transients in the air of wiring. Ultrasound machines also
generate EMI. The system complies with limits as stated on the EMC label. However, there is
no guarantee that interference will not occur in a particular installation.
Possible EMI sources should be identified before the unit is installed.
EMI Rule Prevention Tips
Check for interference
Try using a different circuit.
on the power circuit.
Keep the unit at least 5 meters or 15 feet away from other EMI sources.
Check for interference
Special shielding may be required to eliminate interference problems
from nearby equipment.
caused by high frequency, high powered radio or video broadcast signals.
Poor grounding is the most likely reason why a unit will have noisy images.
Ground the unit
Check grounding of the power cord and power outlet.
After you finish repairing or updating the system, replace all covers and
tighten all screws. Any cable with an external connection requires a magnet
Replace all screws, RF
wrap at each end. Install the shield over the front of card cage. Losing
gaskets, covers, cores
covers or RF gaskets will cause radio frequency interference with the
ultrasound signals.
Do not place labels Never place a label where RF gaskets meet the unit. Otherwise, the gap
where RF gaskets created will permit RF leakage. Or, if a label has been found in such a
touch metal position, move the label.
The interconnecting cables are grounded and require ferrite beads and
Use EDAN supplied
other shielding. Also, cable length, material, and routing are all important;
cables and peripherals
do not change from what is specified.
Cellular phones may transmit a 5V/m signal; that could cause image
Turn off cellular phones
artifacts.
- 49 -
6.7 Troubleshooting the P5-1 flashlight issue

6.7.1. Identifying the P5-1 issue
The “flashlight issue” is a B-mode and Color imaging artifact that can appear with the P5-1
transducer. If a P5-1 is plugged into the system, the following steps show how to identify this
issue:
In B-mode:
 Press the “B” button on hard key control panel to enter B mode.
 Adjust the Gain to 60dB.
 Adjust the Depth to 300mm
 A system with the flashlight artifact will have a bright cone of light in the center of the
image. The artifact gets its name because it looks almost like a flashlight is shining down
the center of the image.
PASS FAIL
Figure 6-1 No flashlight Figure 6-2 flashlight in the middle
In C mode
 Press the “C” button on hard key control panel to enter color mode.
 Adjust the sampling box to the maximum size. (Swipe the trackpad up and down)
 Adjust the Gain to 65dB, there should not be any noise in the image. (Figure 6-3 )
 Adjust Gain to 70dB, the image should have good uniformity, and there should not be any
color flashlight in the center of the image. (Figure 6-5)
- 50 -
PASS FAIL
Figure 6-3 no noise Figure 6-4 noise in the image zone
Figure 6-5 no color lines Figure 6-6 color lines in the middle
6.7.2. Resolving the P5-1 flashlight issue

The P5-1 flashlight issue is generally caused by a broken shielding layer, or by the improper
installation of the ultrasound module. Inspect the following checkpoints and try the suggested
solutions to resolve this issue.
 Comfirm that the ultrasound module is installed properly. Remove the ultrasound module
and re-install it (Refer to section 5.1). Make sure the ultrasound module is inserted
completely.
- 51 -
 Confirm that the slice on the ultrasound module is pushed out when inserting the
ultrasound module. Press the slice onto the metal tightly and fix it with tape if the slice is
pushed out.
 Confirm that both black mylar shielding layers on the bottom of the ultrasound module
slot and on the slides are broken. Tear down and paste on a new one if the mylar is broken.
Mend the shielding layer with tape if the break is small.
- 52 -
6.8 System Password

The system can be configured to require a password at boot time. This can be enabled in
Utilities->Setup->User. Selecting ‘User List’ enables the feature. A list of known users is shown
and the ‘Add’ button will add to this list. Each user is either an ‘Administrator’ or ‘Operator’. An
Administrator can access all exams and change Passwords, while an Operator can only access
exams that they create.
The system ships with two users of Admin1 and Admin2, both predefined with a password of
‘123456’. It is up to the user to change this as needed.
If a customer changes the admin password, and then subsequently forgets the new password, it is
possible for service to reset it. To do so, connect a USB keyboard and mouse to the system, and
then press Ctrl+Shift+M and enter the service password to access the OS manager dialog.
Contact Edan Service if you do not know the service password. Once the OS manager dialog is
displayed, the Restore page will have a “Restore Admin Password” button. Pressing this button
will reset the Admin1 password to “123456”.
Note:
When the password of Admin1 is reset, use Admin1 to login and change the password of
Admin2 on User Set-up Screen.
- 53 -
Acclarix AX8\ Acclarix AX7\ Acclarix AX4 Diagnostic Ultrasound System Service Manual Care and Maintenance
7 Care and Maintenance

Besides the maintenance requirements recommended in this manual, comply with local
regulations on maintenance and measurement.
WARNING
Failure on the part of the responsible individual hospital or institution employing this
equipment to implement a satisfactory maintenance schedule may cause undue
equipment failures and possible health hazards.
Maintenance should be performed according to the schedule provided below. Only authorized
personnel should perform maintenance.
Customer Care Schedule
Interval
Daily Weekly Monthly Others
Item
Clean Transducers √
Clean Control Panel √
Clean Monitor √
Inspect AC Adapter √
Inspect Cables and

√
Connectors
Inspect Safety Label √
Functional tests Semi-annual
Inspect Leakage
Semi-annual
Current
Measurement
Semi-annual
Accuracy Checks
- 54 -
Acclarix AX8\ Acclarix AX7\ Acclarix AX4 Diagnostic Ultrasound System Service Manual Care and Maintenance
Safety Maintenance
The following safety maintenance should be performed at least every 12 months by a qualified
person who has adequate training, knowledge, and practical experience to perform these tests.
 Inspect the safety-related labels for legibility.
 Verify that the device function properly as described in the instructions for use.
 Test the protection earth resistance according to IEC/EN 60601-1 and IEC/EN 60601-2-37:
Limit: 0 - 0.1 Ω.
 Test the earth leakage current according to IEC/EN 60601-1 and IEC/EN 60601-2-37: Limit:
NC 500 μA, SFC 1000 μA.
 Test the patient leakage current according to IEC/EN 60601-1 and IEC/EN 60601-2-37:
Limit: AC NC 100 μA, SFC 500 μA, DC NC 10 μA, SFC 50 μA.
 Test the enclosure leakage current according to IEC/EN 60601-1 and IEC/EN 60601-2-37:
Limit: NC100 μA, SFC 500 μA.
 The leakage current should never exceed the limit.
The data should be recorded in an equipment log. If the device is not functioning properly or any
of the above tests fail, please contact the maintenance personnel of EDAN.
- 55 -
Acclarix AX8\ Acclarix AX7\ Acclarix AX4 Diagnostic Ultrasound System Service Manual Service Record
Appendix I: Service Record

Equipment Information
Model Name Serial Number Service Case Number
Performance Verification
1. System Checks
Transducer model & SN Fail Pass
Transducer
and cables
AC adapter Fail Pass

Control panel Fail Pass
Check the screen and indicators are normal, date/time
displayed on the screen is accurate and no error Fail Pass
message displayed.
Check transducer model and frequencies are accurate. Fail Pass

Check obvious abnormal noise, discontinuous image or
Fail Pass
dark area in B mode image.
Power up Fail Pass
Check unusual smell or over heat
Check the transducer surface to avoid over heat. Fail Pass

Perform all functional tests to verify that control panel,
Fail Pass
touch screen and touchpad are OK.
Check the loudspeaker to avoid abnormal noise Fail Pass
Check the fan to make sure no abnormal noise Fail Pass

2. Functional Checks
Transducer Connection Fail Pass
Battery Performance Fail Pass
Transducer Detection/Selection Fail Pass
System Response
USB Saving Fail Pass
Transducer Frequency Fail Pass
Transducer Depth Fail Pass
Transducer Performance Fail Pass
- 56 -
Check Results
Technician/Signature Date Fail Pass
- 57 -
Acclarix AX8\ Acclarix AX7\ Acclarix AX4 Diagnostic Ultrasound System Service Manual Open Issues and Workarounds
Appendix II Open Issues and Workarounds

The following issues may occur while using the AX8/AX7 1.4 release. With each issue a
workaround is provided.
ID Description Workaround
Occasionally the PW/CW gate
exceeds ROI box when invoke
7695 Move sample line or ROI again.
B+C+Pre_PW/CW or B+C+PW/CW
mode
The image will get stuck for 0.5s
when store clip, also will get stuck
7672, Keep on operating and wait for several
for 3s after finish clip storing.
6941 seconds if you want to observe images.
It has no effect on the function
except UI experience.
Sometimes the M126nw Report
7736 printer can’t print report successfully Plug out and plug in the printer again.
if print test page first.
When connected to a video and a
report printer at the same time, the It can print again after close the prompt
7863 USB video printer can’t print box. Or connect only one printer to the
continuously after printing report system.
printer.
Service or market doctors can
communicate with non-English
Remote support only support
7286 speaking users via telephone or other
English input in chat dialog.
audio communication tools, or can use
English to communicate.
No operation requires using touch
The system gets stuck for a while
screen and touch pad at the same time.
7665 after operating touch screen and
If this case happens, wait until the
touch pad at the same time
system refreshes or restart system.
7897 System may crash in a rare
7821 This is very rare. These steps are
possibility when adjust image
rare to meet in user scene. If this
7739 parameters very quickly or
occurs, restart the machine.
7540 frequently
The system will not boot If there is a problem during boot,
4050 successfully if a footswitch button is ensure that the footswitch is not being
continuously pressed during boot. pressed.
After setting to Manual IP, perform a
DICOM Manual IP sometimes needs
4183 Ping and make sure the IP is still set
to be set twice.
correctly
When the Wi-Fi signal is weak the
5417 Wi-Fi transfers may time out system may take longer to transfer
data. Try moving the system closer to a
- 58 -
router or extending the time-out setting

in set-up.
Transfers to USB terminate if Make sure that the transfer is complete
5658
imaging is re-invoked before exiting the Review function.
Disconnecting and re-connecting Once connected to Wi-Fi, don’t
5727
Wi-Fi takes 30s disconnect.
This is very rare. If this occurs,
5256 Ultrasound Module not found
contact your service representative.
This is very rare. Most of the time,
5678 USB stick not recognized plugging in the USB before entering
Review will work.
When use HP Deskjet 1112 or Canon
When use HP Deskjet 1112 or
E518 printer, if there is lack of paper,
Canon E518 to print a report, it
6065 please fill enough paper, plug out and
could no longer print if there is lack
plug in the printer power cable to
of paper and reload paper
reboot the printer.
The following issues may occur while using the AX4 1.11 release. With each issue a workaround
is provided.
ID Issue Description Workaround
5949 The report could be damaged if If an USB or HD is used to save the report
use a full U disk or HD to export from the Report GUI, ensure the free
report from the Report GUI space is at least 10MB.
6061 If the Sony X898MD and one of the HP
Connect Sony X898MD and one of Deskjet 1112, 2029, Canon E518 are
the HP Deskjet 1112, 2029, Canon connected to the AX8/LX8 system,
E518 printers to the system at the Please set the default printer as “Generic
same time may print out the wrong HP Printer” in
report. “SetupSystemStore/PrintDefault
Printer”
6065 When use HP Deskjet 1112 or Canon
When use HP Deskjet 1112 or
E518 printer, if there is lack of paper,
Canon E518 to print a report, it
please fill enough paper, plug out and
could no longer print if there is lack
plug in the printer power cable to reboot
of paper
the printer.
4050 The system will not boot
successfully if a footswitch button If there is a problem during boot, ensure
is continuously pressed during that the footswitch is not being pressed.
boot.
4183 DICOM Manual IP sometimes After setting to Manual IP, perform a Ping
needs to be set twice. and make sure the IP is still set correctly
5417 When the Wi-Fi signal is weak the system
may take longer to transfer data. Try
Wi-Fi transfers may time out
moving the system closer to a router or
extending the time-out setting in set-up.
- 59 -
5658 Transfers to USB terminate if Make sure that the transfer is complete
imaging is re-invoked before exiting the Review function.
4894 It is difficult to adjust the 3D/4D Use the Set key to toggle between Pos
ROI size with a pinch gesture and Size.
5727 Disconnecting and re-connecting Once connected to Wi-Fi, don’t
Wi-Fi takes 30s disconnect.
5234 This is very rare. If encountered,
Rarely, the QWERTY does not
invoking the patient screen for the current
appear
patient will address this issue.
5256 This is very rare. If this occurs, contact
Ultrasound Module not found
your service representative.
5678 This is very rare. Most of the time,
USB stick not recognized plugging in the USB before entering
Review will work.
5454 Network icon does not appear for The transfer is completed even if the icon
FTP transfer is not shown.
- 60 -
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文件名称：Acclarix AX8&AX7 &AX4 维修手册_英文

版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

Responsibility of the Manufacturer

Terms Used in this Manual

1.1. Warnings and Cautions

 Only authorized personnel should perform service.

 Do not remove system covers or otherwise expose internal electronics. Field

 Only use an Edan supplied power adapter and power cord.

 Do not touch the connector pins on the transducer port.

 To avoid the danger of introducing additional hazards, DO NOT perform any

 Read and follow all manufacturer instructions for disinfection agents.

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

 Do not immerse the transducer beyond the point indicated.

 Do not allow the transducer connector to get wet.

the recycling of waste batteries.

 Do not use in locations subject to vibration.

 Do not use in the presence of a flammable gas.

 Use only Edan supplied or recommended parts and accessories.

 Please read and understand cleaning instructions prior to use.

 Please read and understand maintenance instructions prior to use.

 Ensure that the system vents are clear and unobstructed.

 Do not use disinfection agents beyond their expiration date.

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

 Do not kink or pull on the transducer cable.

 Do not touch the pins of the transducer connector.

1.2. Labeling Symbols

2 P/N Part Number

Refer to User Manual

11 Authorized Representative in the European Community

Disposal method. Indicates that the equipment should be sent to

13 General Symbol for Recovery / Recyclable

Caution: Federal (U.S.) law restricts this device to sale by or on

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

16 IPX7 No harm for short time immersion

17 Type BF Applied Part

19 Pencil Transducer connector (reserved)

20 ECG signal input connector (reserved)

26 Video Output port

27 USB 2.0 port

28 USB 3.0 port

32 Non-ionizing electromagnetic radiation

2.1.2 Power Requirements

2.3. Installing Battery

Figure 2-1 Installation of the Battery

Figure 2-2 Uninstallation of the Battery

Figure 2-3 Installation of the UPS Battery

2.4. Configuring the System

2.5. Connection of Auxiliary Devices

Figure 2-4 Connection of Peripherals

2.5.1. Connecting the Report Printer

2.5.2. Connecting the Video Printer

2.5.3. Connecting the S-Video Printer

3.1. Transducer Connections

Figure 3-1 Transducer Connection

3.2. Battery Performance

3.3. System Response

3.4. Transducer Frequency

Figure 3-2 10 inch touch screen control panel

3.5. Transducer Depth

Figure 3-3 Hard key control panel

3.6. Transducer Performance