DP-50

Digital Ultrasonic Diagnostic

Imaging System

Operator’s Manual

[Basic Volume]
 Contents
Intellectual Property Statement .......................................................................................................... I 
Responsibility on the Manufacturer Party .......................................................................................... I 
Warranty ............................................................................................................................................ II 
Exemptions................................................................................................................................... II 
Customer Service Department .................................................................................................... III 
Important Information ....................................................................................................................... IV 
About This Manual ............................................................................................................................ V 
Notation Conventions ........................................................................................................................ V 
Operator’s Manuals ........................................................................................................................... V 
Manuals on Paper ............................................................................................................................. V 
Software Interfaces in this Manual ................................................................................................... VI 
Conventions ..................................................................................................................................... VI 
1  Safety Precautions ..................................................................................................... 1-1 
1.1  Safety Classification ............................................................................................................. 1-1 
1.2  Meaning of Signal Words ..................................................................................................... 1-2 
1.3  Meaning of Safety Symbols ................................................................................................. 1-2 
1.4  Safety Precautions ............................................................................................................... 1-3 
1.5  Latex Alert .......................................................................................................................... 1-11 
1.6  Warning Labels .................................................................................................................. 1-12 
2  System Overview ........................................................................................................ 2-1 
2.1  Intended Use ........................................................................................................................ 2-1 
2.2  Contraindication ................................................................................................................... 2-1 
2.3  Product and Model Code ..................................................................................................... 2-1 
2.4  Product Specifications .......................................................................................................... 2-1 
2.4.1  Imaging Mode ............................................................................................................... 2-1 
2.4.2  Power supply ................................................................................................................ 2-1 
2.4.3  Environmental Conditions ............................................................................................. 2-2 
2.4.4  Size and weights........................................................................................................... 2-2 
2.5  System Configuration ........................................................................................................... 2-2 
2.5.1  Standard Configuration ................................................................................................. 2-2 
2.5.2  Probes Available ........................................................................................................... 2-2 
2.5.3  Options ......................................................................................................................... 2-4 
2.5.4  Peripherals Supported .................................................................................................. 2-4 
2.6  Introduction of Each Unit ...................................................................................................... 2-5 
2.6.1  I/O Panel ....................................................................................................................... 2-7 
2.6.2  Power Supply Panel ..................................................................................................... 2-7 
2.6.3  Control Panel ................................................................................................................ 2-8 
2.7  Symbols .............................................................................................................................. 2-11 
3  System Preparation .................................................................................................... 3-1 
3.1  Move/Posit the System ........................................................................................................ 3-1 
3.2  Power Supply ....................................................................................................................... 3-1 
3.2.1  Connecting External Power Supply .............................................................................. 3-1 
3.2.2  Powered by Battery ...................................................................................................... 3-1 
3.3  Powering ON/ OFF ............................................................................................................... 3-2 
3.3.1  Powering ON ................................................................................................................ 3-2 
3.3.2  Powering OFF............................................................................................................... 3-3 
3.4  Connecting / Disconnecting a Probe .................................................................................... 3-4 

Contents i
 3.4.1  Connecting a Probe ...................................................................................................... 3-4 
3.4.2  Disconnecting a Probe ................................................................................................. 3-4 
3.5  Connecting the Footswitch ................................................................................................... 3-5 
3.6  Connecting/ Removing a USB Storage Device .................................................................... 3-5 
3.7  Graph / Text Printer .............................................................................................................. 3-5 
3.8  Digital Video Printer.............................................................................................................. 3-8 
3.9  Analog Video Printer ............................................................................................................ 3-9 
3.10  External DVD........................................................................................................................ 3-9 
3.11  Basic Screen and Operation ................................................................................................ 3-9 
3.11.1  Basic Screen................................................................................................................. 3-9 
3.11.2  Basic Operations of Screens ...................................................................................... 3-12 
4  Exam Preparation ....................................................................................................... 4-1 
4.1  Start an Exam ....................................................................................................................... 4-1 
4.2  Patient Information ............................................................................................................... 4-1 
4.2.1  New Patient Information ............................................................................................... 4-1 
4.2.2  Retrieve Patient Information ......................................................................................... 4-5 
4.3  Select Exam Mode and Probe ............................................................................................. 4-7 
4.3.1  Supported Exam Modes ............................................................................................... 4-7 
4.3.2  Selecting Exam Mode and Probe ................................................................................. 4-7 
4.3.3  Dual Probe Switching ................................................................................................... 4-8 
4.3.4  Bi-plane Endocavity Probe (65EB10EA) ...................................................................... 4-9 
4.4  Selecting Imaging Mode ....................................................................................................... 4-9 
4.5  Activate& Continue an Exam ............................................................................................. 4-10 
4.5.1  Activate an Exam ........................................................................................................ 4-10 
4.5.2  Continue an Exam ...................................................................................................... 4-10 
4.6  Pause & End an Exam ....................................................................................................... 4-10 
4.6.1  Pause and Exam ........................................................................................................ 4-10 
4.6.2  End an Exam .............................................................................................................. 4-10 
5  Image Optimization..................................................................................................... 5-1 
5.1  Switching Between Image Modes ........................................................................................ 5-1 
5.2  Basic Operations .................................................................................................................. 5-1 
5.3  B Mode ................................................................................................................................. 5-2 
5.3.1  B Mode Exam Protocol ................................................................................................. 5-2 
5.3.2  B Mode Parameters ...................................................................................................... 5-2 
5.3.3  B Mode Image Optimization ......................................................................................... 5-3 
5.4  M Mode ................................................................................................................................ 5-8 
5.4.1  M Mode Exam Protocol ................................................................................................ 5-8 
5.4.2  M Mode Parameters ..................................................................................................... 5-8 
5.4.3  M Mode Image Optimization......................................................................................... 5-8 
5.5  Image Preset ...................................................................................................................... 5-11 
5.5.1  Image Preset .............................................................................................................. 5-11 
6  Display & Cine Review ............................................................................................... 6-1 
6.1  Image Display....................................................................................................................... 6-1 
6.1.1  Splitting Display ............................................................................................................ 6-1 
6.1.2  Image Magnification ..................................................................................................... 6-1 
6.1.3  Freeze/ Unfreeze the Image ......................................................................................... 6-2 
6.2  Cine Review ......................................................................................................................... 6-3 
6.2.1  Entering/ Exiting Cine Review ...................................................................................... 6-3 
6.2.2  Cine Review in 2D Mode .............................................................................................. 6-4 
6.2.3  Cine Review in M Mode ................................................................................................ 6-4 

ii Contents
 6.2.4  Linked Cine Review ...................................................................................................... 6-5 
6.3  Cine Memory ........................................................................................................................ 6-5 
6.3.1  Cine Memory Setting .................................................................................................... 6-5 
6.3.2  Cine Memory Clear ....................................................................................................... 6-6 
6.4  Preset ................................................................................................................................... 6-6 
7  Measurement............................................................................................................... 7-1 
7.1  Basic operations ................................................................................................................... 7-1 
7.2  General Measurements ........................................................................................................ 7-1 
7.2.1  2D General Measurements .......................................................................................... 7-1 
7.2.2  M General Measurements ............................................................................................ 7-2 
7.3  Application Measurement ..................................................................................................... 7-3 
7.4  Measurement Accuracy ........................................................................................................ 7-4 
8  Comments and Body Marks ...................................................................................... 8-1 
8.1  Comments ............................................................................................................................ 8-1 
8.1.1  Comment Basic Procedures ......................................................................................... 8-1 
8.1.2  Comment Menu ............................................................................................................ 8-1 
8.1.3  Adding Comments ........................................................................................................ 8-2 
8.1.4  Moving Comments ........................................................................................................ 8-3 
8.1.5  Editing Comments ........................................................................................................ 8-3 
8.1.6  Deleting Comments ...................................................................................................... 8-3 
8.2  Body Mark ............................................................................................................................ 8-4 
8.2.1  Body Mark Operation Procedures ................................................................................ 8-4 
8.2.2  Menu ............................................................................................................................. 8-4 
8.2.3  Adding Body Marks....................................................................................................... 8-4 
8.2.4  Moving Body Marks ...................................................................................................... 8-5 
8.2.5  Deleting Body Marks..................................................................................................... 8-5 
9  Patient Data Management .......................................................................................... 9-1 
9.1  Patient Information Management ......................................................................................... 9-1 
9.1.1  Enter Patient Information .............................................................................................. 9-1 
9.1.2  Patient Information Setting ........................................................................................... 9-1 
9.2  Image File Management ...................................................................................................... 9-2 
9.2.1  Storage Media............................................................................................................... 9-2 
9.2.2  Image File Formats ....................................................................................................... 9-2 
9.2.3  Image Storage Preset ................................................................................................... 9-2 
9.2.4  Saving Images to the System ....................................................................................... 9-3 
9.2.5  Quickly Saving Images to USB Flash Drive ................................................................. 9-3 
9.2.6  Quickly Saving Full Screen Image to the System ........................................................ 9-4 
9.2.7  Thumbnails ................................................................................................................... 9-4 
9.2.8  Image Review and Analysis.......................................................................................... 9-4 
9.2.9  iVision ........................................................................................................................... 9-6 
9.2.10  Sending Image File ....................................................................................................... 9-8 
9.3  Report Management............................................................................................................. 9-8 
9.4  Patient Data Management (iStation) .................................................................................. 9-10 
9.4.1  Searching a Patient .................................................................................................... 9-11 
9.4.2  Patient Data View & Management .............................................................................. 9-11 
9.5  Backing Up and Erasing Files through DVD Drive............................................................. 9-13 
9.6  Patient Task Manager......................................................................................................... 9-14 
9.7  Access Control ................................................................................................................... 9-15 
9.7.1  Access Setting ............................................................................................................ 9-15 
9.7.2  Setting Access Control ............................................................................................... 9-15 

Contents iii
 9.7.3  System Login .............................................................................................................. 9-16 
9.7.4  Add/ Delete a User ..................................................................................................... 9-16 
9.7.5  Modify Password ........................................................................................................ 9-18 
10  DICOM ........................................................................................................................ 10-1 
10.1  DICOM Preset .................................................................................................................... 10-1 
10.1.1  Network Preset ........................................................................................................... 10-1 
10.1.2  DICOM Preset ............................................................................................................ 10-2 
10.1.3  DICOM Service ........................................................................................................... 10-4 
10.2  Verify Connectivity ............................................................................................................ 10-11 
10.3  DICOM Service ................................................................................................................ 10-12 
10.3.1  DICOM Storage ........................................................................................................ 10-12 
10.3.2  DICOM Print ............................................................................................................. 10-13 
10.3.3  DICOM Worklist ........................................................................................................ 10-13 
10.3.4  Storage Commitment ................................................................................................ 10-15 
10.4  DICOM Media Storage ..................................................................................................... 10-15 
10.5  DICOM Task Manager ...................................................................................................... 10-16 
11  Setup ...........................................................................................................................11-1 
11.1  System Preset .................................................................................................................... 11-2 
11.1.1  Region ........................................................................................................................ 11-2 
11.1.2  General ....................................................................................................................... 11-3 
11.1.3  Image Preset .............................................................................................................. 11-4 
11.1.4  Meas ........................................................................................................................... 11-5 
11.1.5  OB ............................................................................................................................... 11-5 
11.1.6  Key Config .................................................................................................................. 11-5 
11.1.7  Biopsy ......................................................................................................................... 11-7 
11.1.8  Admin .......................................................................................................................... 11-7 
11.2  Exam Preset ....................................................................................................................... 11-7 
11.2.1  Exam Selection ........................................................................................................... 11-7 
11.2.2  Exam Configuration .................................................................................................... 11-8 
11.3  Image Preset ...................................................................................................................... 11-9 
11.4  Measure Preset .................................................................................................................. 11-9 
11.5  Body Mark Preset ............................................................................................................... 11-9 
11.5.1  Preset Body Mark for Exam Mode.............................................................................. 11-9 
11.5.2  Custom Body Marks ................................................................................................. 11-10 
11.6  Comment Preset ...............................................................................................................11-11 
11.6.1  Custom Comments ....................................................................................................11-11 
11.7  Print Preset....................................................................................................................... 11-13 
11.8  Network Preset ................................................................................................................. 11-14 
11.9  Workstation Preset ........................................................................................................... 11-15 
11.10  Manage Settings .............................................................................................................. 11-15 
11.10.1 Exporting Setup Data................................................................................................ 11-15 
11.10.2 Importing Setup Data ................................................................................................ 11-15 
11.11  Maintenance ..................................................................................................................... 11-16 
11.12  System Information .......................................................................................................... 11-16 
12  Probes and Biopsy ................................................................................................... 12-1 
12.1  Probe .................................................................................................................................. 12-1 
12.1.1  Name and Function of Each Part of the Transducer .................................................. 12-2 
12.1.2  Orientation of the Ultrasound Image and the Transducer Head ................................. 12-4 
12.1.3  Operating Procedures ................................................................................................ 12-5 
12.1.4  Utilizing the Transducer Sheath.................................................................................. 12-7 

iv Contents
 12.1.5  Probes Cleaning and Disinfection .............................................................................. 12-8 
12.1.6  Storage and Transportation ...................................................................................... 12-11 
12.2  Biopsy Guide .................................................................................................................... 12-11 
12.2.1  Basic Procedures for Biopsy Guiding ....................................................................... 12-14 
12.2.2  Needle-guided Brackets ........................................................................................... 12-14 
12.2.3  Biopsy Preset............................................................................................................ 12-19 
12.2.4  Needle-guided Bracket Inspection and Installation .................................................. 12-20 
12.2.5  Biopsy Menu ............................................................................................................. 12-24 
12.2.6  Verify Biopsy Guide Line........................................................................................... 12-24 
12.2.7  Removing the Needle-guided Bracket ...................................................................... 12-25 
12.2.8  Clean and Sterilize the Needle-guided Bracket ........................................................ 12-28 
12.2.9  Storage and Transportation ...................................................................................... 12-29 
12.2.10 Disposal .................................................................................................................... 12-29 
13  Battery ....................................................................................................................... 13-1 
13.1  Overview ............................................................................................................................ 13-1 
13.2  Precautions ........................................................................................................................ 13-2 
13.3  Installing and Removing the Batteries................................................................................ 13-2 
13.4  Battery Status Indicator ...................................................................................................... 13-3 
13.5  Checking Battery Performance .......................................................................................... 13-3 
13.6  Battery Disposal ................................................................................................................. 13-4 
14  Acoustic Output ........................................................................................................ 14-1 
14.1  Concerns with Bioeffects .................................................................................................... 14-1 
14.2  Prudent Use Statement ...................................................................................................... 14-1 
14.3  ALARA Principle (As Low As Reasonably Achievable) ...................................................... 14-1 
14.4  MI/TI Explanation ............................................................................................................... 14-2 
14.4.1  Basic Knowledge of MI and TI .................................................................................... 14-2 
14.4.2  MI/TI Display ............................................................................................................... 14-2 
14.5  Acoustic Power Setting ...................................................................................................... 14-3 
14.6  Acoustic Power Control ...................................................................................................... 14-3 
14.7  Acoustic Output .................................................................................................................. 14-4 
14.7.1  Derated Ultrasonic Output Parameters ...................................................................... 14-4 
14.7.2  Limits of Acoustic Output ............................................................................................ 14-4 
14.7.3  Differences between Actual and Displayed MI and TI ................................................ 14-5 
14.8  Measurement Uncertainty .................................................................................................. 14-6 
14.9  References for Acoustic Power and Safety ........................................................................ 14-6 
15  Guidance and Manufacturer’s Declaration............................................................. 15-1 
16  System Maintenance ................................................................................................ 16-1 
16.1  Daily Maintenance .............................................................................................................. 16-1 
16.1.1  Cleaning the System .................................................................................................. 16-1 
16.1.2  Checking Transducer .................................................................................................. 16-3 
16.1.3  Backup of the System Hard Drive .............................................................................. 16-3 
16.2  Maintenance Checks by Service Engineer ........................................................................ 16-3 
16.3  Consumables and Periodic Part Replacement .................................................................. 16-4 
16.4  Troubleshooting .................................................................................................................. 16-4 
Appendix A  Electrical Safety Inspection .................................................................. A-1 

Contents v
©2011-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2016-09.

This version of the manual applies to 01.04.00 software for the DP-50 ultrasound system.

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this Mindray product and this manual. This manual may
refer to information protected by copyright or patents and does not convey any license under
the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure
of the information in this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.

, , , , , BeneView, WATO,
BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and other
countries. All other trademarks that appear in this manual are used only for informational or
editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable
for errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:
z all installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel;
z the electrical installation of the relevant room complies with the applicable national
and local requirements; and
z the product is used in accordance with the instructions for use.

I
 Note
This equipment must be operated by skilled/trained clinical professionals.

Warning
It is important for the hospital or organization that employs this equipment to carry out a
reasonable service/maintenance plan. Neglect of this may result in machine breakdown or
personal injury.

Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.

This warranty shall not extend to:

„ Malfunction or damage caused by improper use or man-made failure.
„ Malfunction or damage caused by unstable or out-of-range power input.
„ Malfunction or damage caused by force majeure such as fire and earthquake.
„ Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
„ Malfunction of the instrument or part whose serial number is not legible enough.
„ Others not caused by instrument or part itself.

II
Customer Service Department

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building,Keji 12th Road South,High-tech industrial
park,Nanshan,Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail service@mindray.com
Address:
Tel: +86 755 81888998
Fax: +86 755 26582680

Mindray DS USA, Inc.

800 MacArthur Blvd.
Mahwah, NJ 07430-0619 USA
Tel: +1(201) 995-8000
Toll Free: +1 (800) 288-2121
Fax: +1 (800) 926-4275

III
 Important Information
1. It is the customer’s responsibility to maintain and manage the system after delivery.
2. The warranty does not cover the following items, even during the warranty period:
(1) Damage or loss due to misuse or abuse.
(2) Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning,
etc.
(3) Damage or loss caused by failure to meet the specified conditions for this system,
such as inadequate power supply, improper installation or environmental conditions.
(4) Damage or loss due to use of the system outside the region where the system was
originally sold.
(5) Damage or loss involving the system purchased from a source other than Mindray or
its authorized agents.
3. This system shall not be used by persons other than fully qualified and certified medical
personnel.
4. Do not make changes or modifications to the software or hardware of this system.
5. In no event shall Mindray be liable for problems, damage, or loss caused by relocation,
modification, or repair performed by personnel other than those designated by Mindray.
6. The purpose of this system is to provide physicians with data for clinical diagnosis. It is
the physician’s responsibility for diagnostic procedures. Mindray shall not be liable for the
results of diagnostic procedures.
7. Important data must be backed up on external memory media.
8. Mindray shall not be liable for loss of data stored in the memory of this system caused by
operator error or accidents.
9. This manual contains warnings regarding foreseeable potential dangers, but you shall
always be alert to dangers other than those indicated as well. Mindray shall not be liable
for damage or loss that results from negligence or from ignoring the precautions and
operating instructions described in this operator’s manual.
10. If the manager for this system is changed, be sure to hand over this operator’s manual to
the new manager.

IV
About This Manual
This operator’s manual describes the operating procedures for this diagnostic ultrasound
system DP-50 and the compatible probes. To ensure safe and correct operations, carefully
read and understand the manual before operating the system.

Notation Conventions
In this operator’s manual, the following words are used besides the safety precautions (refer
to "Safety Precautions"). Please read this operator’s manual before using the system.

CAUTION: 1. The diagnostic ultrasound system is not intended for

ophthalmic use. Its use in this clinical specialty is
contraindicated.
2. U.S.A. Federal Law restricts this device to sale by or on the
order of a physician.

Operator’s Manuals
You may receive multi-language manuals in compact disc or paper. Please refer to English
manual for latest information and register information.
The content of the operator manual, such as screens, menus or descriptions, may be different
from what you see in your system. The content varies depending upon the software version,
options and configuration of the system.

Manuals on Paper
z Operator’s Manual [Basic Volume]: Describes the basic functions and operations of
the system, safety precautions, exam modes, imaging modes, preset, maintenance
and acoustic output, etc.
z Operator’s Manual [Advanced Volume]: Describes measurement preset,
measurements and calculations, etc.
z Operator’s Manual [Acoustic Power Data and Surface Temperature Data]: Contains
data tables of acoustic output for transducers.
z Operation Note: Contains quick guide for basic operations of the system.

NOTE: 1. The manuals in CD are the manuals translated into languages other than
English according to English manuals.
2. When you find that the contents of the manuals in CD are NOT consistent with
the system or English manuals, please ONLY refer to the corresponding English
manuals.
3. The accompanying manuals may vary depending upon the specific system you
purchased. Please refer to the packing list.

V
 Software Interfaces in this Manual
Depending on the software version, preset settings and optional configuration, the actual
interfaces may be different from those in this manual.

Conventions
In this manual, these conventions are used to describe the buttons on the control panel, the
items in menu, buttons in dialog box and some basic operations:
z <Buttons>: The angular bracket indicates buttons, knobs and other controls on
control panel.
z [Items in menu and buttons in dialog box]: The square bracket indicates items in
menu or buttons in dialog box.
z Click [Items or Button]: Move the cursor to the item or button and press <Set>, or
click it on the menu.
z [Items in Menu]Æ[Items in Submenu]: Selects a submenu item following the path.
z [Dyn Rng (Value)]: Indicates menu items with parameter, (value) shows the current
value of the item.

VI
1 Safety Precautions

1.1 Safety Classification

„ According to the type of protection against electric shock:
CLASS I EQUIPMENT
„ According to the degree of protection against electric shock:
Type-BF applied part
„ According to the degree of protection against harmful ingress of water:
Main unit: IPX0
Probes: IPX7
Footswitch: IP68
„ According to the degree of safety of application in the presence of a FLAMMABLE
ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE:
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC
MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE
„ According to the mode of operation:
CONTINUOUS OPERATION
„ According to the installation and use:
PORTABLE EQUIPMENT
MOBILE EQUIPMENT

Safety Precautions 1-1

 1.2 Meaning of Signal Words
In this manual, the signal words" DANGER”, “ WARNING”, “ CAUTION”,
“NOTE” and "Tips" are used regarding safety and other important instructions. The signal
words and their meanings are defined as follows. Please understand their meanings clearly
before reading this manual.
Signal word Meaning
Indicates an imminently hazardous situation that, if not avoided, will result
DANGER in death or serious injury.
Indicates a potentially hazardous situation that, if not avoided, could result
WARNING in death or serious injury.
Indicates a potentially hazardous situation that, if not avoided, may result
CAUTION in minor or moderate injury.
Indicates a potentially hazardous situation that, if not avoided, may result in
NOTE
property damage.
Tips Important information that helps you to operate the system more effectively.

1.3 Meaning of Safety Symbols

Symbol Description
Type-BF applied part.
The ultrasound probes connected to this system are type-BF applied parts.

Caution

1-2 Safety Precautions

1.4 Safety Precautions
Please observe the following precautions to ensure patient and operator’s safety when using
this system.
DO NOT use flammable gasses, such as anesthetic gas or
DANGER: hydrogen, or flammable liquids such as ethanol, near this
system, because there is danger of explosion.

1. Do connect the power plug of this system and power plugs

WARNING: of the peripherals to wall receptacles that meet the ratings
indicated on the rating nameplate. Using a multifunctional
receptacle may affect the system protective grounding
performance, and cause the leakage current to exceed
safety requirements.
Use the cable provided with this system to connect the
printer. Other cables may result in electric shock.
You must use the power adapter provided with the system;
otherwise electric shock may result.
You can only adopt the power supply method provided by
Mindray, other power supply modes (e.g. using a UPS) may
result in electric shock.
2. Connect the protective grounding conductor before
turning ON the system. Disconnect the grounding cable
after turning OFF the system. Otherwise, electric shock
may result.
3. For the connection of power and grounding, follow the
appropriate procedures described in this operator’s
manual. Otherwise, there is risk of electric shock. DO
NOT connect the grounding cable to a gas pipe or water
pipe; otherwise, improper grounding may result or a gas
explosion may occur.
4. Before cleaning the system, disconnect the power cord
from the outlet. System failure and electric shock may
result.
5. This system is not water-proof designed. Do Not use this
system in any place where water or any liquid leakage
may occur. If any water is sprayed on or into the system,
electric shock or device malfunction may result. If water is
accidentally sprayed on or into the system, contact
Mindray Customer Service Department or sales
representative.
6. Do not use a transducer that has a damaged, scratched
surface, or exposed wiring of any kind. Immediately stop
using the transducer and contact Mindray Customer
Service Department or sales representative. There is risk
of electric shock if using a damaged or scratched
transducer.

Safety Precautions 1-3

 7. DO NOT allow the patient to contact the live parts of the
ultrasound system or other devices, e.g. signal I / O
ports. Electric shock may occur.
8. DO NOT touch the Signal I/O ports if in contact with the
patient; otherwise patient injury may result.
9. Do not use an aftermarket probe other than those
specified by Mindray. The probes may damage the
system causing a profound failure, e.g. a fire in the worst
case.
10. Do not subject the transducers to knocks or drops. Use
of a defective transducer may cause an electric shock.
11. Do not open the covers and front panel of the system.
Short circuit or electric shock may result when the
system hardware is exposed and powered on.
12. Do not use this system when any digital device such as a
high-frequency electrotome, high-frequency therapeutic
device or defibrillator is applied already. Otherwise, there
is a risk of electric shock to the patient.
13. When moving the system, you should first fold the
keyboard, disconnect the system from other devices
(including probes) and disconnect the system from the
power supply.
14. Accessory equipment connected to the analog and digital
interfaces must comply with the relevant IEC standards
(e.g., IEC 60950 information technology equipment safety
standard and IEC 60601-1 medical equipment
standard).Furthermore, all configurations must comply
with the standard IEC 60601-1-1.It is the responsibility of
the person, who connects additional equipment to the
signal input or output ports and configures a medical
system, to verify that the system complies with the
requirements of IEC 60601-1-1.If you have any questions
regarding these requirements, consult your sales
representative.
15. Prolonged and repeated use of keyboards may result in
hand or arm nerve disorders for some individuals.
Observe the local safety or health regulations concerning
the use of keyboards.
16. When using intra-cavity transducers, do not activate the
transducer outside the patient’s body.
17. The operator SHOULD NOT touch SIP/SOP and the
patient at the same time.
18. If the battery cannot be automatically maintained in a
fully usable condition, please conduct periodic checking
of the battery.

1-4 Safety Precautions

 19. The ultrasound system use a mains plug as isolation
means to the mains power supply. Please do not set the
ultrasound system in a place difficult to operate the
mains plug.
20. Do not modify this equipment without authorization of
the manufacture.

1. Precautions concerning clinical examination techniques:

CAUTION:
z This system must be used only by qualified medical
professionals.
z This operator’s manual does not describe clinical
examination techniques. The clinician should select the
proper examination techniques based on specialized
training and clinical experience.
2. Malfunctions due to radio wave:
z If a radio wave emitting device is used in the proximity of
this system, it may interfere with operations. Do not bring
or use devices that generate radio waves, such as
cellular telephones, transceivers, and radio controlled
toys, in the room where the system is installed.
z If a person brings a device that generates radio waves
near the system, ask him / her to immediately turn OFF
the device.
3. Precautions concerning movement of the system:
z When you place the system on the mobile trolley and
move them together, you must secure all objects on the
mobile trolley to prevent them from falling. Otherwise you
should separate the system from the mobile trolley and
move them individually.
When you have to move the system with the mobile
trolley upward or downward the stairs, you must separate
them first and then move them individually.
z Object placed on the monitor may fall and injure an
individual when moving.
z Fasten and fully secure any peripheral device before
moving the system. A loose peripheral device may fall
and injure an individual.
4. DO NOT expose the system to excessive vibration
through transportation. Mechanical damage may result.
5. Do not connect this system to outlets with the same
circuit breakers and fuses that control the current of
devices such as life-support systems. If this system
malfunctions and generates overcurrent, or when there is
an instantaneous current at power ON, the circuit breakers
and fuses of the building’s supply circuit may be tripped.
6. Always keep the system dry. Avoid transporting this
system quickly from a cold place to a warm place;
otherwise condensation or water droplets may form
allowing a short circuit and possible electric shock.

Safety Precautions 1-5

 7. If the circuit protector is tripped, it indicates that the
system or a peripheral device was improperly shut down
and the system is unstable. You cannot repair the system
under this circumstance and must call the Mindray
Customer Service Department or sales representative.
8. There is no risk of high-temperature burns during normal
ultrasound examinations. It is possible for the surface
temperature of the transducer to exceed the body
temperature of a patient due to environmental temperature
and exam type combinations. Do not apply the transducer
to the same region on the patient for a long time. Apply
the transducer only for a period of time required for the
purpose of diagnosis.
9. The system and its accessories are not disinfected or
sterilized prior to delivery. The operator is responsible for
the cleaning and disinfection of transducers and
sterilization of biopsy brackets according to the manuals,
prior to the use. All items must be thoroughly processed
to completely remove harmful residual chemicals, which
will not only be harmful to the human body, but also
damage the accessory.
10. It is necessary to press [End Exam] to end the current
scan that is in progress and clear the current Patient
Information field. Otherwise, new patient data may be
combined with the previous patient data.
11. DO NOT connect or disconnect the system’s power cord
or its accessories (e.g., a printer) without turning OFF the
power first. This may damage the system and its
accessories or cause electric shock.
12. If the system is powered off improperly during operation,
it may result in data damage of the system’s hard disk or
system failure.
13. Do not use the system to examine a fetus for a long period
of time.
14. Do not use a USB memory device (e.g., a USB flash drive,
removable hard disk) which has unsafe data. Otherwise,
system damage may result.
15. It is recommended to only use the video devices specified
in this manual.
16. Do not use gel, disinfectant, probes, probe sheath or
needle-guided brackets that are not compatible with the
system.
17. Read the Acoustic Output Principle in the operation
manual carefully before operate this system on clinical
examination.
18. Please use the ultrasound gel compliant with the relevant
local regulations.

1-6 Safety Precautions

 19. The ultrasound system can be powered by connecting to
mains power supply or powered by internal battery, if you
have any doubt with stability of mains power protective
grounding, please use internal battery.

NOTE: 1. DO NOT use the system in the vicinity of strong electromagnetic field (such
as a transformer), which may affect the performance of the system.
2. DO NOT use the system in the vicinity of high-frequency radiation source,
which may affect the performance of the system or even lead to failure.
3. When using or placing the system, keep the system horizontal to avoid
disbalance.
4. To avoid damaging the system, DO NOT use it in following environment:
(1) Locations exposed to direct sunlight;
(2) Locations subject to sudden changes in environmental temperature;
(3) Dusty locations;
(4) Locations subject to vibration;
(5) Locations near heat generators;
(6) Locations with high humidity.
5. Turn ON the system only after the power has been turned OFF for a while. If
the system is turned ON immediately after being turned OFF, the system may
not be rebooted properly and could malfunction.
6. Remove ultrasound gel from the face of a probe when the examination is
complete. Water in the gel may enter the acoustic lens and adversely affect
the performance and safety of the transducer.
7. You should properly back up the system to a secure external storage media,
including system configuration, settings and patient data. Data stored to the
system’s hard drive may be lost due to system failure, improper operation or
accident.
8. Do not apply external force to the control panel, otherwise, the system may
be damaged.
9. If the system is used in a small room, the room temperature may rise. Please
provide proper ventilation and free air exchange.
10. To dispose of the system or any part, contact Mindray Customer Service
Department or sales representative. Mindray is not responsible for any
system content or accessories that have been discarded improperly. Mindray
is not responsible for any system content or accessories that have been
discarded improperly.
11. Electrical and mechanical performance may be degraded due to long usage
(such as current leakage or distortion and abrasion), the image sensitivity and
precision may become worse too. To ensure optimal system operations, it is
recommended that you maintain the system under a Mindray service
agreement.
12. Ensure that the current exam date and time are the same as the system date
and time.
13. DO NOT turn OFF the power supply of the system during printing, file storage
or invoking other system operations. An interrupted process may not be
completed, and can become lost or corrupted.

Safety Precautions 1-7

 14. The system should be powered by battery when the integrality and reliability
of the protective grounding of external power supply is indeterminate.
15. The replaceable fuse is inside the chassis. Refer replacing job to Mindray
service engineers or engineers authorized by Mindray only.

1-8 Safety Precautions

Please read the following precautions carefully to ensure the safety of the patient and the
operator when using the probes.
The ultrasonic probe is only for use with the specified
WARNING: 1. ultrasonic diagnostic system. Please refer to the “2.5.2
Probes Available” to select the proper probe.
The ultrasonic probe must be used only by qualified
2.
professionals.
Confirm that the probe and cable are normal before and
3. after each examination. Electrical shock may result from
a defective probe.
Do not subject the probe to shock. A defective probe may
4.
cause electric shock to the patient.
Do not disassemble the probe to avoid the possibility of
5.
electric shock.
Never immerse the probe connector into liquids such as
water or disinfectant because the connector is not
6.
waterproof. Immersion may cause electric shock or
malfunction.
A probe sheath must be installed over the probe before
7.
performing intra-cavity or biopsy examination.

When using the probe, wear sterile gloves to prevent

CAUTION: 1.
infection.
Be sure to use ultrasound sterile gel. Please use the
ultrasound gel compliant with the relevant local
2.
regulations. And manage the ultrasound gel properly to
ensure that it does not become a source of infection.
In normal diagnostic ultrasound mode, there is no danger
of a normal-temperature burn; however, keeping the probe
3.
on the same region of the patient for a long time may
cause such a burn.
Do not use the carrying case for storing the transducer. If
4. the carrying case is used for storage, it may become a
source of infection.
It is required to practice ALARA when operating
5. ultrasound system. Minimize the acoustic power without
compromising the quality of images.
The probe and accessories supplied with it are not
6. delivered disinfected or sterilized. Sterilization (or high-
level disinfect) before use is required.
Disposable components are packaged sterile and are
single-use only. Do not use if integrity of packaging
7. violated or if expiration date has passed. Please use the
disposable components compliant with the relevant local
regulations.

Safety Precautions 1-9

 Please use the disinfection or sterilization solution that
recommended in this operator’s manual, otherwise
Mindray will not be liable for damage caused by other
8.
solutions. If you have any questions, please contact
Mindray Customer Service Department or sales
representative.
The probe sheath contains natural rubber that can cause
9.
allergic reactions in some individuals.
Do not use pre-lubricated condoms as a sheath. Lubricant
10. may not be compatible with the transducer material and
damage may result.
Transducer damage may be caused by inappropriate gel,
detergent or cleanser:
Do not soak or saturate transducers with solutions
11. containing alcohol, bleach, ammonium chloride
compounds, acetone or formaldehyde.
Avoid contact with solutions or coupling gels containing
mineral oil or lanolin.

NOTE: 1. Read the following precautions to prevent the probe from malfunction:
z Clean and disinfect the transducer before and after each examination.
z After the examination, wipe off the ultrasound gel thoroughly.
Otherwise, the ultrasound gel may solidify and the image quality
would be degraded.
2. Ambient conditions:
To prevent the transducer from being damaged, do not use it where it will be
exposed to:
z Direct sunlight or X-rays
z Sudden changes in temperature
z Dust
z Excessive vibration
z Heat generators
Use the probes under the following ambient conditions:
z Ambient temperature: 0°C ~ 40°C
z Relative humidity: 30% to 85% (no condensation)
z Atmospheric pressure: 700 hPa ~ 1060 hPa
3. Repeated disinfection will eventually damage the probe, please check the
probe's performance periodically.

1-10 Safety Precautions

1.5 Latex Alert
When choosing a probe sheath, it is recommended that you directly contact CIVCO for
obtaining probe sheath, pricing information, samples and local distribution information. For
CIVCO information, please contact the following:
CIVCO Medical Instruments
Tel: 1-800-445-6741
WWW.civco.com
Allergic reactions in latex (natural rubber) sensitive patients may
WARNING: range from mild skin reactions (irritation) to fatal anaphylactic
shock, and may include difficulty in breathing (wheezing),
dizziness, shock, swelling of the face, hives, sneezing or itching
of the eyes (FDA Medical Alert on latex products, “Allergic
Reactions to Latex-containing Medical Devices”, issued on March
29, 1991).

Safety Precautions 1-11

 1.6 Warning Labels
The warning labels are attached to this system in order to call your attention to potential
hazards. The warning labels use the same signal words as those used in the operator’s
manual. Read operator’s manual carefully before using the system.
The name, pattern and meaning of each warning label are described as follows:
No. Warning Labels Meaning
1 Please carefully read this manual
before use device.

2 The following label is available when the a. Do not place the device on a
system works with the mobile trolley. sloped surface. Otherwise the
device may slide, resulting in
personal injury or the device
malfunction. Two persons are
a required to move the device over a
sloped surface.
b. Do not sit on the device.
c. DO NOT push the device when
b c the casters are locked.

3 The machine has only one of the certification labels below.

Please refer to the label attached to the machine to determine the applicable
certification label.
Medical equipment with respect to
electric shock, fire and mechanical
hazards only in accordance with
UL60601-1, CAN/CSA-C22.2
NO.601.1-M90, IEC60601-1-1 and
IEC60601-2-37.

The presence of this label indicates

the machine was certified by ETL
with the statement:
CONFORMS TO UL STD 60601-1,
IEC 60601-2-37，IEC60601-1-1
CERTIFIED TO CSA STD C22.2 No
601.1, CSA STD
C22.2.60601.2.37，CSA STD C22.2
NO.60601-1-1

1-12 Safety Precautions

2 System Overview

2.1 Intended Use

The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women,
pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small
organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal,
musculo-skeletal(conventional, superficial), cardiac(pediatric) and peripheral vascular exams.

2.2 Contraindication
The diagnostic ultrasound system is not intended for ophthalmic use.

2.3 Product and Model Code

DP-

Model code
Product code

NOTE: The functions described in the operator’s manual may vary depending upon the
specific system you purchased.

2.4 Product Specifications

2.4.1 Imaging Mode
B Mode B
M Mode M

2.4.2 Power supply

Voltage 100-240V～
Frequency 50/60Hz
Input Power 1.5-0.8A

System Overview 2-1

 2.4.3 Environmental Conditions
Operational Conditions Storage and Transportation Conditions
Ambient 0℃～40℃ -20℃～55℃
temperature
Relative 30%～85% (no condensation) 30%～95% (no condensation)
humidity
Atmospheric 700hPa～1060hPa 700hPa～1060hPa
pressure

Do not use this system in the conditions other than those

WARNING: specified.

2.4.4 Size and weights

z Size: 190mm×415mm×378mm (Depth×Width×Height)
z Net Weight: 8.6 kg (including battery and ACDC module)

2.5 System Configuration

2.5.1 Standard Configuration
„ Main unit
„ Accessories
z Operator’s manual
z Ultrasound gel
z Power cable
z Multilingual controls overlay
z Probe holder

2.5.2 Probes Available

Region
No. Probe Model Category Intended Use
Applied
Fetal, Abdominal, Pediatric, Musculo-
1. 35C50EA Convex Body surface
skeletal Conventional, Peripheral Vascular
Abdominal, Pediatric, Neonatal Cephalic,
2. 65C15EA Convex Body surface
Adult Cephalic, Cardiac Pediatric
Convex Fetal, Trans-rectal, Trans-vaginal Transvaginal
3. 65EC10EA
Transrectal
4. 65EB10EA Convex Trans-rectal Transrectal
Linear Abdominal, Pediatric, Small organ, Neonatal
5. 75L38EA Cephalic, Musculo-skeletal (conventional, Body surface
superficial), Peripheral Vascular

2-2 System Overview

 Region
No. Probe Model Category Intended Use
Applied
Linear Abdominal, Pediatric, Small organ, Neonatal
6. 75L53EA Cephalic, Musculo-skeletal (conventional, Body surface
superficial), Peripheral Vascular
Abdominal, Pediatric, Small organ, Neonatal
7. 10L24EA Linear Cephalic, Musculo-skeletal (conventional, Body surface
superficial), Peripheral Vascular

Some of the probes have matched needle-guided brackets for biopsy, the available probes
and the corresponding needle-guided brackets are listed as follows:

Needle-guided Biopsy Angle/

Probe Model Applicable Biopsy Needle
Bracket Model Depth (±1°)
NGB-001
Metal/needle 13G, 15G, 16G, 18G, 20G
35C50EA detachable; 25°, 35°, 45°
14G, 16G, 18G, 20G, 22G
metal/needle un-
detachable
NGB-002
75L38EA metal/needle un- 40°, 50°, 60° 13G, 15G, 16G, 18G, 20G
detachable
65EC10EA NGB-004
/
metal/needle un- 16G, 17G, 18G
65EB10EA detachable
NGB-005
65C15EA metal/needle un- 12.7°, 24.2° 13G, 15G, 16G, 18G, 20G
detachable
NGB-007
Plastic/needle Metal: 14G, 16G, 18G, 20G, 22G
75L53EA detachable; 40°, 50°, 60°
Plastic: 13G, 15G, 16G, 18G, 20G
Metal/needle
detachable
NGB-016
10L24EA Metal/needle 30°, 40°, 50° 14G, 16G, 18G, 20G, 22G
detachable

System Overview 2-3

 2.5.3 Options
No. Item
1 iClear module
2 IMT module
DICOM basic module (including: task management, DICOM storage, DICOM print,
3 DICOM storage commitment, DICOM media storage (including DICOM DIR) and
etc.)
DICOM worklist module (only can be applied with the DICOM basic function module
4
configured)
DVD R/W Drive:
5
Model: SE-S224 (USB port)
6 Footswitch
7 Battery Pack (LI34I002A)
8 Mobile Trolley (UMT-150 or UMT-160)
9 Needle-guided bracket
10 Pack

2.5.4 Peripherals Supported

No. Item Model
HP deskjet 1280
HP Color Laserjet CM1015
1. Graph / text printer
HP officejet 6000
HP officejet J3608 all-in-one
SONY UP-D25MD
2. Color Video Printer
MITSUBISHI CP910E
SONY UP-D897
MITSUBISHI P93W-Z
Black and White Video
3. SONY UP-D897
Printer
SONY UP-D898MD
SONY UP-X898MD
4. External DVD R/W Drive SE-S224
5. USB removable storage device
6. Footswitch
Parts that can be used within patient environment:
z Main unit.
z Probes.
z Footswitch.
z Printers: SONY UP-D25MD, MITSUBISHI CP910E, SONY UP-D897, MITSUBISHI
P93W-Z, SONY UP-D898MD, SONY UP-X898MD

2-4 System Overview

 This system complies with IEC60601-1-2:2007, and its RF
WARNING: emission meets the requirements of CISPR11 Class B. In a
domestic environment, the customer or the user should
guarantee to connect the system with Class B peripheral devices;
otherwise RF interference may result and the customer or the
user must take adequate measures accordingly.

NOTE: If the ultrasound system can not recognize the SONY UP-X898MD and SONY UP-
D898MD printers automatically, you may need to change the settings on the
printer: push <PUSH ENTER> to enter the main menu and select [DIGITAL]-
>[DRIVER], and select [897].

2.6 Introduction of Each Unit

System Overview 2-5

 5

9
7

10

No. Name Function

1 Probe holder Used to place the probe
Displays the image and parameters during scanning (tilt angle
2 LCD Display
adjustable)
3 Control Panel Refer to the 2.6.3 Control Panel.
4 Lock button (x2) Press to release the control panel while it’s folded
5 Handle Used to carry the machine

2-6 System Overview

No. Name Function
Interface panel used for inputting and outputting signals, refer
6 I/O Panel
to 2.6.1 I/O Panel.
7 Power supply panel Electrical port panel, refer to 2.6.2 Power Supply Panel.
8 Probe ports Used to connect the probe
9 Battery cover Used to hold the battery
10 USB ports Used to connect USB devices

2.6.1 I/O Panel

<1>
<2> <3> <4>
12V

5V

<5> VGA <6> <7> 3.3V

A
<8>

No. Symbol Function

1 Network port
2
USB ports
3
4 Separate video output, connecting video printer or LCD
5 Remote control port

6 VGA VGA signal output

7 Composite video output
8 / Power indicator

2.6.2 Power Supply Panel

<1>

<2>
100-240~ 50/60Hz 1.5-0.8A

System Overview 2-7

 No. Name Function
1 Power inlet AC power inlet
Used for equipotential connection, that balances the
2 Equipotential terminal protective earth potentials between the system and other
electrical equipment.

2.6.3 Control Panel

No. Name Description Function

Off: when system is turned off;
1 / Power button Green: when system is turned on by pressing this
button.
Exit Press to exit the current status to the previous
2 Esc
status.
/ Press to display or hide the help information on
3 Help
screen.
4 Review / Press to review the stored images.
5 Report / Press to open or close the diagnosis reports.
/ Press to enter or exit the patient information
6 iStation
management system.

2-8 System Overview

No. Name Description Function
User-defined You can assign a function to the key.
7 F1~F4
key
8 Biopsy / Press to show or hide the biopsy guide line.
9 Setup / Press to open/close the setup menu.
10 Del / Press to delete the comment, etc.
Alphanumeric Same as on PC
11 /
keys
12 Arrow / Press to enter or exit the arrow comment status.
Main menu Press to display or hide a mode-specific
13 Menu
parameter menu.
14 Cine Cine Review Press to enter or exit the Cine Review status.
Direction key To adjust LCD brightness or contrast when
15 /
pressing with <Fn> key.
16 TGC / Move to adjust time gain compensation.
Focus Press: to switch between Focus and Freq./THI;
17 /
Freq./THI Rotate: to adjust corresponding parameter
Depth Press: to switch between Depth and Zoom;
18 /
Zoom Rotate: to adjust corresponding parameter
Patient
19 Patient Press to open/ exit patient information screen.
Information
20 Body Mark / Press to enter or exit the Body Mark status.
21 Probe Probe switch Press to switch Probe and Exam Type
/ Press to enter or exit the character comment
22 Comment
status.
23 End Exam / Press to end an exam.
/ Press to clear the comments or measurement
24 Clear
calipers on the screen.
25 Cursor / Press to show the cursor.
26 Nav.Rot / Multifunction knob
Quad-split Press to enter Quad mode from non-Quad mode;
27 Quad screen Press to switch between windows in Quad mode.
Dual-split Press to enter Dual mode from non-Dual mode;
28 Dual
screen Press to switch between windows in Dual mode.
29 M / Press to enter the M mode.
30 B / Press to enter the B mode
31 Measure / Press to enter/ exit Application Measurement
Measurement status: press to switch between the
fixed and active end of the caliper;
32 Update /
Multi-imaging mode: press to change the
currently active window.

System Overview 2-9

 No. Name Description Function
33 Caliper / Press to enter/ exit General Measurement
Rotate: to adjust B or M gain
34 Gain/ iTouch /
Press: to enter/ exit iTouch
35 Save 1 / Press to save, user-defined key
36 Save 2 / Press to save, user-defined key
Press to confirm an operation, same as the left-
37 Set /
button of a mouse.
38 / Trackball Roll the trackball to change the cursor position.
Press to confirm an operation, same as the left-
39 Set /
button of a mouse.
40 Freeze / Press to freeze or unfreeze the image.
41 Print / Press to print: user-defined key.
AC indicator
42 / Indicator 1 AC supply: light green;
Battery supply: light off.
Indicator 2 Battery status indicator
Charging: light in orange
Full: light in green
Discharge (electricity >20%): light in green
43 / Discharge (electricity <20%): blinking in
orange
Discharge (electricity <5%): blinking in
orange rapidly
Non-charge/ discharge: light off
Indicator 3 Standby indicator
44 / Standby: blinking in orange
Other status: light off
HDD status indicator
Read/ write: blinking in green
45 / Indicator 4 Other status: light off
NOTE: DO NOT move the machine when the
indicator blinking in green. Otherwise the HDD
may be damaged by sudden shake.

2-10 System Overview

2.7 Symbols
This system uses the symbols listed in the following table, and their meanings are explained
as well.
Symbol Description

Type-BF applied part

Caution

Dangerous voltage

Equipotentiality

Power button

Network port

USB ports

Video output

Remote control port

VGA VGA signal output

AC (Alternating current)

Battery Status Indicator

Standby indicator

Hard disk indicator

Probe port A
A

Probe port B
B

Product serial number

Manufacture date

System Overview 2-11

3 System Preparation

3.1 Move/Posit the System

Please read and understand the safety precautions before placing the system to ensure
safety for both operator and devices.
1. Switch off the power, and pull out the plug.
2. Disconnect the system from all peripherals.
3. Place the system in a desired location by holding the handle.
4. Leave at least 20cm at the back and both sides of the system.
Maintain enough space around the back and both sides of
CAUTION: the system for plugging/ unplugging the power cord freely,
as well as avoiding system failure resulted due to
increased system operating temperature.

3.2 Power Supply

This system can work normally only when it is connected to the external power supply or the
battery capacity is sufficient.

3.2.1 Connecting External Power Supply

A three-wire power cord is used to connect the system with the external power supply.
The external power supply system must meet the following requirements:
Voltage:100-240V～
Frequency: 50/60Hz
Input current: 1.5- 0.8 A

3.2.2 Powered by Battery

When connected to the external power supply, the system is powered by the external power.
The lithium ion battery inside it is in charging status. When disconnected from the external
power supply, the system is powered by the lithium ion batteries.
Refer to “13 Battery” for the detailed operations and precautions.

System Preparation 3-1

3.3 Powering ON/ OFF
3.3.1 Powering ON
To ensure safe and effective system operation, you must
CAUTION: perform daily maintenance and checks. If the system begins
to function improperly – immediately stop scanning. If the
system continues to function improperly – fully shut down
the system and contact Mindray Customer Service
Department or sales representative. If you use the system in a
persistent improperly functioning state – you may harm the
patient or damage the equipment.

„ Checking before Power-on

To check the system before turning on the system:
No. Check Item
The temperature, relative humidity and atmospheric pressure shall meet the
<1> requirements of operating conditions. See "2.4.3 Environmental Conditions" for
details.
<2> There shall be no condensation.
There shall be no distortion, damage or dirt on the system and peripheral
devices.
<3>
If any dirt is found, cleaning shall be performed as defined in section “16.1.1
Cleaning the System”.
<4> There shall be no loose screws on the LCD or control panel.
There shall be no cable damage (e.g. power cord). Maintaining secure
<5>
connections to the system at all times.
The probes and probe cables shall be free of damage or stains.
<6> See “12.1.5 Probes Cleaning and Disinfection” for details on probe cleaning
and disinfection.
No miscellaneous odds and ends are allowed to be attached or affixed to the
<7>
control panel.
Ensure that all connections are free from damage and remain clear of foreign
<8> object blockages.
There shall be no obstacles around the system and its air vent.
<9> Probe cleaning and disinfection.
<10> The overall scanning environment and field must be clean.
„ Checking after it is turned on
Press the power button in the upper right corner on the control panel.
To check the system after the system is turned on:
No. Check Item
There shall be no unusual sounds or smells indicating possible
<1>
overheating.
<2> There shall be no persistently displayed system error message.

3-2 System Preparation

 No. Check Item
There shall be no evident excessive noise, discontinuous, absent or black
<3>
artifacts in the B Mode image.
Check if there is abnormal heat on the surface of the probe during an
<4>
ultrasound procedure.
<5> The control panel keys and knobs are fully functional.
The exam date and time are the same as the system date and time, and
<6>
are displayed correctly.

1. If you use a probe giving off excessive heat, it may burn

WARNING: the patient.
2. If you find anything not functioning properly, this may
indicate that the system is defective. In this case, shut
down the system immediately and contact Mindray
Customer Service Department or sales representative.

NOTE: When you start the system or switch between probes, you will hear clicking
sounds – this is expected behavior.

3.3.2 Powering OFF

You need to follow the correct procedures to power off the system. In addition, after you
upgrade the software or when the system is down, you need to power off and restart it. 
If you will not use the system for a long period of time, after powering off the system, you shall
disconnect the external power supply; turn off powers of all peripherals connected to the
system. 
„ To power off your system normally:
Gently press the power button once on the upper right corner of the control panel. The
[Shutdown Confirm] screen appears. See the figure below.

z Shut down: To power off the system normally.

z Standby: To enter the standby status.
z Cancel: To cancel the operation.
„ To shut down the system in a direct way if you cannot do it normally:
Press and hold the power button for a long time and the system will power off without
displaying the [Shutdown Confirm] screen. Shutting down the system this way may destroy
the data.

System Preparation 3-3

NOTE: 1. DO NOT rush shutdown of the system in a direct way. It may destroy the
data.
2. After the software upgrade, please shut down the system in the normal way
(using “Shut down” method) so as to guarantee a fully update.

3.4 Connecting / Disconnecting a Probe

1. When connecting or disconnecting a probe, place it in a
CAUTION: proper position, to prevent the probe from falling off or
becoming damaged.
2. Only use the probes provided by Mindray. Aftermarket
probes may result in damage or cause a fire.

3.4.1 Connecting a Probe

Before connecting to the system, check if the probes, cables
WARNING: and connectors are in proper operating order and free from
surface defects, cracks and peeling. Using a defective probe
may cause electric shock.
1. Check if the locking lever on the probe is locked, or unlock it by turning it
counterclockwise to horizontal.
2. Insert the probe connector into the port with the probe cable pointing to the holder.
3. Lock the lever by turning it clockwise.
4. Place the cable properly to avoid being treaded or wrapping with other devices. DO
NOT allow the probe head to hang free.

3.4.2 Disconnecting a Probe

1. Turn the probe lock lever counterclockwise to release the connector.
2. Pull the connector straight out.
3. Keep the probe in safety and care.

3-4 System Preparation

3.5 Connecting the Footswitch
Connect the footswitch to the main unit via a USB port.
Set the functions of the footswitch in the [Key Config] page. Refer to "11.1.6 Key Config" for
details.

3.6 Connecting/ Removing a USB Storage

Device
DO NOT detach an USB storage device directly;
WARNING: otherwise , the ultrasound system or the USB device and/
or data stored in the device may be damaged.
„ When connecting a USB storage device to the ultrasound system, you can see the
symbol in the lower right corner of the screen.

„ To remove the USB storage device: Click to open the [Remove USB Device] screen.
Select the device to be removed. Click [OK].

3.7 Graph / Text Printer

„ Connecting a local printer
As shown in the figure below, a graph / text printer has a power cord and data cable. The
power cord shall be directly connected to a wall receptacle as required.

Power cord

Data cord

USB port

1. Connect the data cable with the USB port on the system.
2. Plug the other end power plug into an appropriate outlet.

System Preparation 3-5

3. Power on the system and the printer.
4. Install the printer driver (drivers of printers listed in “2.5.4 Peripherals Supported” have
already installed):
(1) Enter [Setup]-> [Print Preset].
Enter “Printer Driver” page and the printers that are installed automatically will be
displayed in the list with the “Status” of “Ready”.

(2) Return to “Print Service” page, and select printer from the “Printer” list.

3-6 System Preparation

Drivers of some HP printers have already been integrated in the system, and will be installed
automatically. If the auto-installation fails, a warning icon will display on the right lower corner
of the screen. You need to install the printer driver manually:
a) Download the ppd file from the printer’s official website (contact R&D engineer if
necessary), and copy the ppd file to the storage device (USB disk as an
example).
b) Connect the USB disk to the ultrasound system, run the ppd file and finish the
installation.。
5. Select the printer after installation, and set the Properties.
6. Click [OK] to finish.
„ Add network printer
1. As the system is connected into a LAN, open [Setup]-> [Printer Preset]-> [Printer Driver]
screen.
2. Click [Add Network Printer], and input information of the printer (IP Address, Shared
Printer Name, User name, Workgroup and Password).
3. After successful connection, return to Printer Driver page, and the printer name will be
listed on the page.

NOTE: 1. Before connectting the network printer, make sure the ultrasound system
and the printer are in the same network domain, and the network is
working normally.
2. The IP address and the server name should be valid, e.g. \\10.2.40.123
or \\5-HP, otherwise, the system will fail to connect.
3. If the server has set accessing limitation, the system will prompt a
dialogue box to identify the user. Enter the correct user name, domain
name and password, and then click [OK].

System Preparation 3-7

„ Print Service
You can use a graph/ text printer to print report or images.
z To set the default report printer and its attribute:
In "[Setup]-> [Print Preset]" screen, select the "Print Service", select “Report Print”
column in the service list, set the items in the "Property" box.
z Report print:
Click [Print] in the report dialog box to print a report; or, use the user-defined key to
print, see "11.1.6 Key Config" for details.Please refer to the accompanying manuals
of the printers for more details.

3.8 Digital Video Printer

„ Install a local printer
1. Put the printer in a proper place.
2. Connect the printer (VIDEO IN port) and the ultrasound system (USB port) with the data
cable.
3. Load a paper roll, and turn on the system and printer.
4. Install the printer driver (steps are the same as of graph/text printer, please refer to “3.7
Graph / Text Printer” for details). And you need not install the driver of the printer listed in
section “2.5.4 Peripherals Supported”.
5. Add a print service:
(1) Open [Setup]-> [Print Preset]->[Print Service].
(2) Click [Add Service] to enter the following page.

(3) Select the service type as "Digital Image Print" and enter the service name manually.
(4) Click OK to return to the Printer Service page.
(5) Set the items in the Property box and click [Save] to save the settings.

„ Image print
For DICOM image printing, refer to “10 DICOM”.
z Modify print service:
a) Select an existed printer service in the list.
b) Select the printer type in the Property box.
c) Set the attribute: paper size, orientation, etc.
d) Click [OK] to confirm.
z Image print
h Select the image to be printed on the iStation or Review screen, and click [Send
To] to select the printer to print.
Please refer to the accompanying manuals of the printers for more details.

3-8 System Preparation

3.9 Analog Video Printer
1. Connect the printer (VIDEO IN port) and the ultrasound system (S-Video on IO panel)
with the signal cable;
2. Connect the Remote cable on printer to the Remote port on the ultrasound system.
3. Connect the power cord to a power supply receptacle that is well grounded.
4. Install the printer driver (steps are the same as of graph/text printer, please refer to “3.7
Graph / Text Printer” for details). And you need not install the driver of the printer listed in
section “2.5.4 Peripherals Supported”.
5. Add a print service. Please refer to “3.8 Digital Video Printer”.

3.10 External DVD

1. Connect the USB cable of the DVD recorder to the USB port on the ultrasound system
(all USB ports available).
2. Connect the power adapter of the DVD on the power supply.

3.11 Basic Screen and Operation

3.11.1 Basic Screen
The following diagram maps out the different areas in the screen:
Hospital name Accession#
Patient Information Freeze
Logo Operator Exam time
icon
Probe Acoustic power, MI/TI
Product Mode
Exam Mode

Menu area Image area Image Parameters

Thumbnail Cine Review Area

preview&
zoom Bodymark & Comment
window

Thumbnail Area of Images Saved

Help information area System status icon

System Preparation 3-9

„ Information Area
The information area displays manufacturer logo, hospital name, exam date & time,
acoustic power & MI/TI, freeze icon, patient information, probe model, current exam mode,
and accession #, etc. It can be preset whether to display the operator, patient gender, age,
ID, name etc. via [Setup]-> [System Preset]-> [General]. See “11.1.2 General” for detailed
preset procedures.
z Manufacturer logo
Manufacturer logo, displayed in the upper left corner of the screen.
z Hospital name
Displays the hospital name. Hospital name can be set via [Setup]-> [System Preset]-
> [Region].
z Exam time
Displays the exam time, including date and time. Exam time can be set via [Setup]->
[System Preset]-> [Region]. Exam time will be frozen with the frozen image.
z Acoustic power & MI/TI
Displays the acoustic power. Including the acoustic power, MI (Mechanical Index)
and TI (Thermal Index).
z Freeze icon
The freeze icon means the image is frozen.
z Patient Information
Displays patient name, ID, gender and age etc. Enter the patient information through
the "Patient Info" screen. Or, import the saved patient data from iStation or the
DICOM Worklist server.
z Probe model
Display the currently-used probe model, or the default model.
z Exam Mode
Displays the currently used exam type, e.g. Abdomen, is displayed.
z Operator
Displays the operator’s name on the screen. This information is entered through the
[Patient Info] screen.
z Accession#
The accession # indicates exam number used in hospital information system. It can
be imported via DICOM or input manually.
„ Menu area
Include image menu, measurement menu, comment menu, bodymark menu and so on.
Use the trackball or the multifunctional knob to operate on the menu.
To show or hide the image menu, press <Menu> key on the control panel.
The menu area consists of menu title, menu items. As shown in figure below.

3-10 System Preparation

 Menu title

Tags

Items

h Menu title
Displays the menu name.
h Tags
Attribute tags of the item.
h Items
Refers to the items on a menu. For item that is applicable for more than one mode,
the item appears as universal item in the certain mode. Items of image modes and
measurement can be preset (refer to "11 Setup" for details).
h Return to previous menu
Click [Return] to return to the previous menu from the sub menu.
The multifunction knob can be used to operate the menu. Press the know to open the
menu; rotate the know to navigate through the items one by one.
Depending on the item types, the multifunction knob can:
h For a commanding item or command optional item: press the knob to directly
activate the item.
h For a parameter item or ON/OFF item: press the knob to lock and select the item,
then rotate the knob to switch among the available values; press the knob again
to release and deselect the item.
h For an item with sub-menu: press the knob to extend the sub-menu, and the
cursor navigates to the first sub-item. At the same time, you can exit from the
sub-menu to the previous item by clicking [Return] in the sub-menu.
h For tag items in the menu: e.g. the “Right” and “Left” tag in the measurement
menu. Rotate the multifunctional knob to navigate the tag, and press the knob to
select the tag.
„ Parameter area
Displays the image parameters for the activating window. If there are more than one
imaging modes, the parameters are displayed by each mode. For detailed parameters
displayed in this area, please refer to the corresponding imaging mode (s).
„ Image area
The image area displays the ultrasound images, probe mark (or activating window mark),
time line (in M mode), coordinate axis (including depth, time, velocity/frequency), focus

System Preparation 3-11

 position (located at depth axis in the form of ), besides, the annotation, bodymark,
measurement calipers, grayscale bar are also displayed here.

„ Thumbnail preview & Zoom Window (image-in-image)

In the zoom status, this area displays the thumbnail of a complete image, and a
rectangular frame is used to highlight the currently magnified area. This feature is called
image-in-image.
„ Help information area
The help information area displays various help information or progress bar in the current
status.
Besides, the system can provide help for each key. Press [Help] to enter key-help status,
you can see the cursor changes into an arrow with a question mark on it. Press any key
on the control panel, the screen displays the key-relevant information, meanwhile, the
system exits the key-help status.
Tips: in terms of help information, “TB” refers to “Trackball”, “Knob refers to Multifunction
knob.
„ Thumbnail area of images stored
Displays the thumbnail images stored under the current patient.
„ Image manage area
z Page-turning: when there are more than one page images have been stored, you can
turn to the next or preview page by or respectively.
z Delete: select a thumbnail image , and click to delete it.
z Send to: select a thumbnail image , and click to send it to other devices.

„ System status icon

This area displays the relevant system icons, such as USB memory device, printer,
network, Chinese / English entry, and current system time, etc.
„ None-fixing Area
Position of areas illustrated here are not fixed, you can move them by the trackball within
a certain area on the display.
z Result window
The measurement result window displays the results of recently performed
measurements.
To move the result window:
a) Place the cursor on the title of result window (you can see the cursor changes
into ).
b) Press <Set> and move the trackball, the window moves together with the cursor.
c) Move the cursor to the target position, press [Set] again to anchor the result
window in the target position.
z Comment area
For details, please refer to “8 Comments and Body Marks”.
z Body mark area
For details, please refer to “8 Comments and Body Marks”.

3.11.2 Basic Operations of Screens

A screen consists of title, page tabs, contents and buttons, as shown in the following figure:

3-12 System Preparation

 Title
Tab

Contents

Control
button

Composition Description
The title bar is used to give a description for the content and
Title Bar
function of the screen.
For some screens, contents are distributed across several
pages. Use the selection pointer and <Set> key to
Page Tab
open/close the available pages. Use the selection pointer
and [Set] key to open / close the available pages.
„ Radio button: click to select the item.
„ Check box: click to check or uncheck the item.
„ Entry box: enter characters manually via the keyboard.
Content Position the cursor into the box, and then enter the
letters or characters.
„ Drop-down list box: click [▼] to show the list and select
an item.
When the operation of a screen is complete, press the [OK]
[OK] and [Cancel] or [Cancel] button to save or cancel the operation, and close
the screen.
To reposition a dialogue box:
1. Roll the trackball to move the cursor onto the title bar of the dialogue box. At this time the
cursor becomes a ; press the [Set] key.
2. Roll the trackball and reposition the rectangular graphic to the new desired location.
3. Press the <Set> key, and the dialogue box is moved to the desired position.

System Preparation 3-13

4 Exam Preparation
Before examining a new patient, press <End Exam> to end the
CAUTION: exam of the previous patient, update the patient ID and
information, to avoid mixing data of the next new patient.

4.1 Start an Exam

You can start a patient exam in the following situations:
z New patient information: to start a new patient exam, enter the patient information
first, for details, please refer to “4.2.1 New Patient Information”.
z New exam: to start a new exam for an already recorded patient, the recorded
information can be obtained either through iStation or Worklist, refer to "4.2.2.1
iStation"and "4.2.2.2 DICOM Worklist" for details.
z Activate an exam: select an exam that is ended within 24 hours, and continue the
exam with the imported patient information and exam data. For details, please refer
to “4.5 Activate& Continue an Exam”.
z Continue an exam: select an exam that is paused within 24 hours, and continue the
exam with the imported patient information and exam data. For details, please refer
to “4.5 Activate& Continue an Exam”.
General procedure for an exam: enter the patient information-> select an exam mode and
probe -> choose an imaging mode -> start the exam.
To start a new patient exam, it is better to enter the detailed patient information. The system
will set up a unique information database for each patient based on the patient information
entered, so that the information of one patient will not be confused with that of another patient.

4.2 Patient Information

„ To enter the "Patient Info" screen
z Press <Patient>, or,
z Move the cursor onto the patient information area on the display and press <Set> to
open the screen.
„ To exit the "Patient Info" screen
z Click OK on the "Patient Info" screen; or, press <Patient> on the control panel again,
to save the settings and exit the screen.
z Click [Cancel] or press <Esc> to exit the screen without saving any of the entered
patient data.
z Press <B> or <Freeze> to return to the current exam mode with the entered
information being saved.
„ Click [Quick Register] on the screen to save the patient information quickly and return to
the main screen.

4.2.1 New Patient Information

The Patient Info page is shown as below:
Place the cursor onto the targeted box. The field box is highlighted and a flashing cursor
appears. Information can be entered or selected from the options.

Exam Preparation 4-1

You can also change the cursor position by <Tab>, <Enter> or up/down controls

2
3

4
Information includes:
1. General information
z Name
Enter patient name through the keyboard. Characters of A through Z and 0 through 9 and
“.” are allowed. “\”, “^”, “＝” and “, ” are not permitted.
z Patient ID
Patient ID is generated automatically by the system after starting a new patient, and can
be modified manually. Once you enter the ID and confirm it, you are not allowed to
change it.
NOTE: 1. “\” is not permitted.
2. If enter an ID that is already existed in the system, a warning “The ID
existed, load data” prompts, and you can import the patient data. The
patient data can be edited after importing.
z Other ID
The second ID of the patient used for other information like insurance ID.
z Gender
Select Male, Female or Unknown for patient gender in the drop down list.
z DOB (Date of birth):
h You can either enter the birth date of a patient manually;
h Or, click to select the date, and click [OK] to confirm.
z Age
h Auto generated age: once the DOB is gotten, the system can display an auto-
generated age in the field box, the unit can be “Years”, “Months” or “Days”. If the
age is less than one year, the system will automatically calculate the age in
months or days.
h Also, you can manually enter the age.

4-2 Exam Preparation

NOTE: When you enter the date manually, please enter it in the format as that of the
system.
2. Exam Type
z Exam application type
You can select among: ABD (Abdomen), OB (Obstetrics), GYN (Gynecology), CARD
(Cardiac), VAS (Vascular), URO (Urology), SMP (Small Part), and PED (Pediatrics).
Select the exam type tab to enter the exam-specific information.
z General information:
Study to enter description for each exam.
description:
Primary to enter the primary indications (reason to perform the
indications: exam.)
Secondary to enter the secondary indications.
indications:
CPT4 code: to enter the CPT4 code.
CPT4 to enter the CPT4 description.
description:
z Exam specified information:
Exam Type Information Description
Height /
Weight /
ABD
(Abdomen) BSA (body After the height and weight are inputted, the system will
surface automatically calculate the BSA based on the formula which
area) is set via [Setup]-> [System Preset]-> [General].
Calculate gestation age (GA) and estimated delivery date
(EDD) based on last menstrual period (LMP), in vitro
fertilization (IVF), basic body temperature (BBT), previous
exam date (PRV). Select LMP, IVF, PRV, BBT, or EDD from
the drop-down list; or, calculates GA and LMP according to
the EDD and entered date.
z LMP: After you enter LMP, the system will calculate
Calculation and display GA and EDD.
index z IVF: After you enter IVF, the system will calculate GA
and EDD.
z PRV: input the date and GA of the last exam, the
OB system will calculate a new GA and EDD.
(Obstetric)
z BBT: input BBT, the system will calculate the GA and
EDD.
z EDD: after you enter EDD, the system will calculate
and display GA and LMP.
Gravida Times of pregnancy.
Ectopic Times of abnormal pregnancy. e.g. extrauterine pregnancy
Gestations Number of embryos (1, 2, 3; 1 is default)
Para Times of delivery
Aborta Times of abortion
GYN LMP Last menstrual period

Exam Preparation 4-3

 Exam Type Information Description
(Gynecology) Gravida Times of pregnancy.
Para Times of delivery
Ectopic Times of abnormal pregnancy. e.g. extrauterine pregnancy
Aborta Times of abortion
Height /
Weight /
BSA (body After the height and weight are inputted, the system will
CARD surface automatically calculate the BSA based on the formula which
(Cardiac) area) is set via [Setup] -> [System Preset] ->[General].
BP Blood pressure.
HR /
RA Press Right Atrium Pressure

VAS BP(L) Input left blood pressure.

(Vascular) BP(R) Input right blood pressure.
Serum PSA /
URO
(Urology) PPSA
/
coefficient
SMP (Small
None /
Parts)
PED
None /
(Pediatrics)
3. Operating Information
z Ref. Physician: the people who requires the operator to do the ultrasound operation.
“\”, “^”, “＝” and “,” are not permitted.
z Diagnostician: people who is responsible for exam. “\”, “^”, “＝” and “,” are not
permitted.
z Operator: people who is responsible for images collection and scanning. “\”, “^”, “＝”
and “,” are not permitted.
z Accession #: exam number used in DICOM, “\” is not permitted.
z Comment: exam-specific explanation or remarks.
4. Functional key
z [New Patient]: click to clear the current patient information in the patient information
screen in order to input new patient information.
z [New Exam]: click to clear the current exam information in order to create a new
exam for the current patient.
z [Pause Exam]: to pause the current exam.
z [OK]: click to save the patient data entered and exit the screen.
z [Cancel]: click to cancel the patient data entered and exit the screen.

4-4 Exam Preparation

4.2.2 Retrieve Patient Information
4.2.2.1 iStation
The patient data can be obtained in iStation from the system hardware or USB memory
device. You can enter the searching conditions for the patient.
1. To enter iStation screen (the screen is shown as follows):
z Press <iStation> on the control panel; or,
z Click [iStation] in the "Patient Info" screen; or
z Press the <Review> key on the control panel and click [iStation] in the screen.

2. Select the data source:

Select the data source in the drop-down list of "Data Source".
3. Input the searching condition:
Item: including Name, ID, DOB and Exam Date, the default one is name; then enter a
keyword in accordance with the Item selected.
z Select “Find in results”, the system will search the keyword based on the existed
searched results.
4. Select the desired patient information in the list. The following menu pops up:

Exam Preparation 4-5

 Button Function Description
Review
Click to enter the Review screen.
Image
Patient
Click to enter the Patient Info screen.
Info
Review
Click to enter the Diagnostic Report screen.
Report
Delete
Click to delete the selected record.
Exam
Backup
Click to export the selected patient data to media supported.
Exam
Restore
Click to import the patient data from an external media.
Exam
Send Click to send the selected patient data to external device,
Exam DICOM storage server or DICOM printer.
Active
Click to continue an exam finished within 24 hours.
Exam
Continue Click to continue an unfinished exam carried out within 24
Exam hours.
Other buttons:
z [New Exam]: Click to enter Patient Info screen, meanwhile, the corresponding patient
information is also imported to the new exam. After you edit the patient information in
the Patient Info screen, select [OK] to start a new exam.
z [Select All Exams]: Click to select all records.
z [Exit]: click to exit iStation.

4.2.2.2 DICOM Worklist

When the DICOM basic package is configured and the Worklist server has been set, click
[Worklist] in the "Patient Info" screen to query or import the patient data. (For the setting of
Worklist server, please refer to “10 DICOM”.)
Procedure:
1. Select data source: choose a worklist server in the drop-down list of “Worklist Server”,
and then all the patient exam records in the server are listed out.
2. Input the searching condition:
z Select exam date period, click [Query] to search the patient data in the period.
z Enter patient ID, patient name, accession #, the system affords the result in real-time.

4-6 Exam Preparation

 z Or select the keyword type, enter the keywords and then click [Query] to search.
z To reset the criteria, click [Clear] button.
3. Select the desired patient from the list.
z Click [Start Exam], the patient information is imported into the system and then an
exam is started.
z Click [Transfer], the patient information is imported into the Patient Info screen. Edit
the patient information in the Patient Info screen, and select [OK] to start a new exam.
z Click [Show Detail] to see details of patient data.
4. Click [Exit] to exit the Worklist.

4.3 Select Exam Mode and Probe

If the exam mode is changed during a measurement, all
CAUTION: measurement calipers on the image will be cleared. The data of
general measurements will be lost, but the data of application
measurements will be stored in the reports.

4.3.1 Supported Exam Modes

The system supports to preset application type, measurements, comments, body marks,
image parameters for each exam mode(including user-defined exam modes). For details,
please refer to “11.2.2 Exam Configuration”.
You can select exam modes for the probes. For details, please refer to “11.2.1 Exam
Selection”.

4.3.2 Selecting Exam Mode and Probe

„ Select Probe and Exam Mode
(1) Press <Probe> to open the following dialog box.

Exam Preparation 4-7

 (2) Roll the trackball and press <Set> to select the exam mode, and use the direction
keys to turn pages of the exam modes.
„ To save the image parameters for the current exam mode quickly:
(1) Click [Save] to save the image parameters in the current image mode as presets. A
dialogue box pops up to prompt you the operation will cover the current image preset
data.
(2) Click [Save as] to save the current image parameters to the designated exam mode.
„ Click [Exam Preset] to enter the exam preset screen. For exam preset, please refer to
"11.2 Exam Preset".
„ Exit:
Click [Exit] or press <Probe> to exit, press <B>, <Freeze> or <ESC> can also exit the
screen.

4.3.3 Dual Probe Switching

You can preset user-defined key to implement switching probes between single B and 2B
mode. The function is only available to the probes of the same exam mode.
„ In single B mode: press the user-defined key to switch the current window between two
probes (with Cine Memory in [Image Preset] is set to “Split”)
„ In Dual B mode: press the user-defined key to switch two windows between two probes.
Preset the user-defined key via [Setup](by pressing <Setup>)-> [System Preset]-> [Key
Config].
1. Select the user-defined key in the Key Function page on the left (Print, Save1, Save2,
F1~F4); or, select the key of footswitch.
2. Select “Dual Probe” in the page of Advanced Features on the right.
3. Click [OK] to confirm the setting and exit the dialog box.
4. After returning the preset, the setting will take effect.

4-8 Exam Preparation

4.3.4 Bi-plane Endocavity Probe (65EB10EA)

„ Selecting Exam Mode

1. Connect 65EB10EA to the ultrasound system.
2. Press <Probe> on the control panel to enter the exam mode selecting screen. Roll the
trackball and press <Set> to switch the S or T plane of the probe, or select the exam
mode of the S/T plane of 65EB10EA probe.

„ Dual Probe Function (user-defined key)

1. Connect 65EB10EA to the ultrasound system.
2. Press <Setup> to enter the setup screen, select [System Preset] -> [Key Config] to enter
the page.
3. Select the user-defined key in the Key Function page on the left; or, select the key of
footswitch.
4. Select [Dual Probe] in the page of Advanced Features on the right.

5. Click [OK] to confirm the setting and exit the dialog box.
6. Press the defined key on the control panel for [Dual Probe] function, both the S plane and
T plane image of the probe will be displayed on the screen. Press the user-defined key to
switch between the two windows to activate the current window.

4.4 Selecting Imaging Mode

Use the corresponding key in the control panel to enter the imaging modes.
For the detailed operations in each imaging mode, please refer to “5 Image Optimization”.

Exam Preparation 4-9

4.5 Activate& Continue an Exam
4.5.1 Activate an Exam
Select an exam finished within 24 hours, select the exam record, click from the menu
popped up; or, click [Active Exam] in “iStation” or “Review” screen to activate the exam.
Note:
z The system can automatically load the patient information and exam data to continue
the exam.
z If you want to continue an exam which data lies in an external memory database, you
have to first allow the system to load the patient data to the system’s patient
database.

4.5.2 Continue an Exam

Select an exam paused within 24 hours, select the exam record in iStation screen,
click from the menu popped up to continue the exam.
If you want to continue an exam which data lies in an external memory database, you have to
first allow the system to load the patient data to the system’s patient database.

4.6 Pause & End an Exam

4.6.1 Pause and Exam
„ Sometimes, you have to stop an uncompleted exam due to some special causes. When
the exam is paused, the system can begin other exams.
1. Press <Patient> to enter "Patient Info" screen.
2. Click [Pause Exam].
„ If the system is powered off during scanning, the exam status turns "paused" after the
system restart.
Only one exam can be paused every time.
When an exam is paused, the system will:
1. Saves the exam-related images, reports and measurement data, modifies the status as
“Paused”.
2. Save the exam information, including report, imaging mode, exam mode, image
parameters, operation mode, imaging / measurement data and so on.

4.6.2 End an Exam

Before examining a new patient, press <End Exam> to end the exam of the previous patient,
update the patient ID and information, to avoid mixing data of the next new patient.
To end an exam, you can do one of the following:
z Press <End Exam> on the control panel.
z Click [New Patient] on the Patient Info screen to end the last patient exam and clear
the patient information.
z Click [New Exam] on the Patient Info screen (or iStation screen, or Review screen) to
end the last exam and clear the exam data.

4-10 Exam Preparation

5 Image Optimization
1. The images displayed in this system are only reference for
WARNING: diagnosis. Mindray is not responsible for the correctness of
diagnostic results. It is the responsibility of the clinician,
who performs the exam, to capture the correct diagnostic
results.
2. In Dual-B imaging mode, the measurement results of the
merged image may be inaccurate. Therefore, the results are
provided for reference only, not for confirming a diagnosis.

5.1 Switching Between Image Modes

Key Description

B Mode key: press to enter B mode

M Mode key: press to enter M mode

Dual-split display key: press to enter the Dual-split display mode, and press to
switch between the window

Switching key: Press to change the currently active window.

Press to enter the quad-split screen display, or switch image window in the
Quad mode.

5.2 Basic Operations

Before optimizing the image by adjusting image parameters, adjust the brightness and
contrast of the display to the best.

Requirement Available Operations

Adjust [Gain].
To modify the Adjust TGC
brightness Adjust [Acoustic Power] (try adjusting gain before
increasing the acoustic power)

Image Optimization 5-1

 Requirement Available Operations
Adjust [Dynamic Range]
To modify gray scale Adjust [Map]
image effect Adjust [Persistence]
Adjust [iClear]
Decrease [Depth]
Decrease the [Focus Number]
To increase frame
Decrease the [FOV]
rate
Decrease [Line Density]
Turn on [High FR] in harmonic mode
„ Adjusting through Image Menu:
Press <Menu> or multifunctional knob to open the menu; use the trackball and <Set> or
the multifunctional knob to adjust.
„ Adjusting through control panel:
Trackball, control panel key, knob or sliders.

5.3 B Mode
B mode is the basic imaging mode that displays real-time images of anatomical tissues and
organs.

5.3.1 B Mode Exam Protocol

1. Enter the patient information, and select the appropriate probe and exam mode.
2. Press <B> on the control panel to enter B mode.
3. Adjust parameters to optimize the image.
4. Perform other operations (e.g. measurement and calculation) if necessary.
In real-time scanning of all image modes, press <B> on the control panel to return to B mode.

5.3.2 B Mode Parameters

In B mode scanning, the image parameter area in the upper left corner of the screen displays
the real-time parameter values as follows:

Display F 2.5M D 21.3 G 100 FR 34 IP 1 DR 65

Parameter Frequency Depth Gain Frame Rate B IP B Dynamic
Range

5-2 Image Optimization

5.3.3 B Mode Image Optimization
Gain
Description To adjust the gain of the whole receiving information in B mode. The real-time
gain value is displayed in the image parameter area in the upper left corner of
the screen.
Operation Rotate the <Gain/iTouch> knob clockwise to increase the gain, and
anticlockwise to decrease.
The adjusting range is 0-100.
Effects Increasing the gain will brighten the image and you can see more received
signals. However, noise may also be increased.

Depth
Description This function is used to adjust the display depth of sampling, the real-time
value of which is displayed on the image parameter area in the upper left
corner of the screen.
Operation Use the <Depth/Zoom> knob to adjust the depth.
The adjustable depth values vary depending upon the probe types.
Effects Increase the depth to see tissue in deeper locations, while decrease the depth
to see tissue in shallower locations.
Impacts Depth increase will cause a decrease in the frame rate.

TGC
Description The system compensates the signals from deeper tissue by segments to
optimize the image.
There are 8-segment TGC sliders on the control panel corresponding to the
areas in the image.
Operation To increase the gain compensation at an area of interest, move the TGC slider
to the right. To decrease the gain compensation at the corresponding area of
interest, move the TGC slider to the left.
About 1.5s after the adjustment is finished, the TGC curve disappears.
Effects Adjust the signal gain for the certain image area to get a balanced image.

Frequency
Description This function is used to select the operating frequency of the current probe,
the real-time value of which is displayed in the image parameter area in the
upper left corner of the screen, where “F” represents B mode frequency, and
“FH” represents harmonic frequency.
Operation Adjust it through [Frequency] on the image menu, wherein “H” means the
harmonic frequency.
Values of frequency vary depending upon the probe types. Select the
frequency according to the detection depth and current tissue characteristics.
Effects The higher the frequency the better the near field resolution but the worse the
force of penetration.
Harmonic imaging enhances near field resolution and reduces low-frequency
and large amplitude noise, so as to improve small parts imaging.

Image Optimization 5-3

A. power
Description Refers to the power of ultrasonic wave transmitted by the probe, the real-time
value of which is displayed in the image parameter area in the upper left corner
of the screen.
Operation Adjust through the [Acoustic Power] item in the image menu;
The adjusting range is 7%-100% in increments of 3%.
Effects Generally, increasing the acoustic power will increase the brightness and
contrast of the image as well as the force of penetration.
Impacts You should perform exams according to actual situation and follow the ALARA
Principle.

Focus
Description Refers to adjustment of focus of the ultrasonic beams, symbols as " " of
which will be displayed on the right of the image.
Operation Adjust the focus number through the [Focus Number] in the menu;
Adjust the focus position through the [Focus Position] in the menu;
In B Mode, focus number can be switched among 1-4.
Effects The area that is focused will be of a higher contrast and resolution to provide
a much clearer image.
Impacts The greater the number of focus, the slower the frame rate to image.

Imaging Display Adjustment

Description More information can be obtained without moving the probe or changing the
sampling position.
Operation Change the scan range through the [FOV] item in the menu;
The system provided levels of: ExFOV, W, N, M1, M2.
You can get a much larger field of view when selecting a larger FOV, but the
frame rate will decrease.
B Steer This function is to steer the beam transmitted by the probe.
Steer the transmitting beam through the [B Steer] item in the menu;
The steering angles provided are: -6, 0, 6.
Trapezoid Turn on or off the function through [Trapezoid] item in the menu.
imaging You can define user-defined key for trapezoid function via [Setup]-> [System
Preset]-> [Key Config].
Impacts The B Steer and Trapezoid function are available only for linear probes.

Line Density
Description The function determines the quality and information of the image.
Operation Adjust through the [Line Density] item in the menu;
Levels: UH/ H/ M/ L.
Effects The higher the line density, the higher the resolution, and the lower the frame
rate.

5-4 Image Optimization

Dynamic Range
Description This function is used to adjust the B image resolution to compress or expand
the gray display range.
The real-time dynamic range value is displayed on the image parameter area
in the upper left corner of the screen.
Operation Adjust through the [Dyn Ra.] item in the menu.
The adjusting range is 30-220dB in increments of 5dB.
Effects The more the dynamic range, the more specific the information, and the lower
the contrast with more noise.

iClear
Description This function is used to increase image profile, so as to distinguish the image
boundary.
Operation Adjust through the [iClear] item in the menu;
The system provides 5 levels of iClear effects adjustment, off represents no
iClear is turned on, and the bigger the value the stronger the effect.
Effects The bigger the value the clearer the profile of the image.

Smooth
Description Rejects image noise and makes images smooth.
Operation Adjust through the [Smooth] item in the menu;
The system provides 4 levels of smooth function, the bigger the value the
higher the smooth adjustment.

Persistence
Description This function is used to superimpose and average adjacent B images, so as to
optimize the image and remove noises.
Operation Adjust through the [Persistence] item in the menu;
The system provides 8 level of frame average adjustment, the bigger the
value the stronger the effect.
Effects Persistence can remove image noise to make details to be clearer.
Impacts Persistence increase may lead to signal missing.

Rotation/ Invert
Description This function provides a better observation for image display.
Invert To invert the image horizontally or vertically.
Click [L/R Flip] or [U/D Flip] in the menu to invert the image.
Rotation Rotate the image through the [Rotation] item in the menu.
Image can be rotated by the manners in angle of 0°, 90°, 180°, 270°.
When the image is rotated in the angle of 90° or 270°, the depth scale is
displayed on the upper part of the screen.
When you flip or rotate an image, the “M” mark will change its position on the screen; the M
mark is located in the upper left corner of the imaging area by default.
Impacts The function is available in real-time imaging, freeze or cine review status.

Image Optimization 5-5

iBeam
Description This function is used to superimpose and average images of different steer
angles to obtain image optimization.
Operation Adjust through the [iBeam] item in the menu;
Off: no iBeam
On: maximum iBeam optimization
Effects Images after iBeam processing can be optimized with less spot noise and
higher resolution, so that more details for the structure are revealed.
Impacts iBeam is not available when trapezoid function is turned on.

Auto Merge
Description In the Dual-split mode, when the images of the two windows use the same
probe type, depth, invert status, rotation status and magnification factor, the
system will merge the two images so as to extend the field of vision.
Operation Turn on/ off the function through the [Auto Merge] item in the menu;
Impacts Available only for linear probes.
The function is available in real-time imaging, freeze or cine review status.

Gray Map
Description Adjusting grayscale contras to optimize the image.
Operation Select among the maps through the [Gray Map] item in the menu.
The system provides 8 gray maps to be selected among.
Impacts The function is available in real-time imaging, freeze or cine review status.

IP
Description IP is a combination of several image processing parameters, which is used for
a fast image optimization, the real-time group of which is displayed in the
image parameter area in the upper left corner of the screen.
The IP combination parameters include dynamic range, iClear, persistence,
and smooth.
Operation Select among the IP groups through the [IP] item in the menu.
The system provides 8 groups of IP combinations, and the specific value of
each parameter can be preset.

Colorize and Colorize Map

Description Colorize function provides an imaging process based on color difference
rather than gray distinction.
Operation Turn on/ off the function through the [Colorize] item in the menu;
Select the colorize map through the [Colorize Map] item in the menu;
The system provides 16 colorize maps to be selected among.
Impacts The function is available in real-time imaging, freeze or cine review status.

5-6 Image Optimization

TSI
Description The TSI function is used to optimize the image by selecting acoustic speed
according to tissue characteristics.
Operation Select among the TSI modes through the [TSI] item in the menu;
The system provided 4 ways of optimization for specific tissues: general,
muscle, fluid and fat.

iTouch
Description To optimize image parameters as per the current tissue characteristics for a
better image effect.
Operation Press <Gain/ iTouch> on the control panel, the iTouch symbol will display in
the image parameter area.
Click [iTouch] on the image menu to adjust gain in iTouch status among -12
through 12dB.
Click [iTouch Bright] on the image menu to adjust brightness in iTouch status
among -2 through +2.

Gray Rejection
Description This function is to reject image signals less than a certain gray scale, then the
rejected signal corresponding area turns black.
Operation Click [Gray Rejection] in the menu to adjust.
The adjusting range is 0-5.

Curve
Description To manually enhance or restrain the signal in the certain scale.
Operation Click [Curve] in the menu to open the dialogue box to adjust.
Drag the curve node to increase or decrease the gray scale information: drag
the node up to increase the information and down to decrease.

γ
Description The γ correction is used to correct non-linear distortion of images.
Operation Click [γ] on the image menu to adjust.
The adjusting range is 0-3, increase the value, the image turns dark.

Gray Invert
Description Reverse the polarity of the image.
Operation Click [Gray Invert] to turn on or off the image inversion.

Impacts The gray rejection, curve, γ and gray invert functions are available in real-time
imaging, freeze or cine review status.
These post process adjustments will not influence the cine review.

High FR
Description Increases the frame rate when being turned on in THI mode.

Image Optimization 5-7

Operation In single B mode when THI is turned on, click the [High FR] item in the menu
to obtain images with high frame rates.

HScale
Description Display or hide the width scale (horizontal scale).
The scale of the horizontal scale is the same as that of vertical scale (depth),
they change together in zoom mode, or when the number of the image
window changes. The HScale will be inverted when image is turned up/down.
Operation Click [HScale] on the menu to display or hide the scale.

5.4 M Mode
5.4.1 M Mode Exam Protocol
1. Select a high-quality image during B mode scanning, and adjust to place the area of
interest in the center of the B mode image.
2. Press <M> on the control panel, and roll the trackball to adjust the sampling line.
3. Press <M> on the control panel again or <Update> to enter M mode, then you can
observe the tissue motion along with anatomical images of B mode.
4. During the scanning process, you can also adjust the sampling line accordingly when
necessary.
5. Adjust the image parameters to obtain optimized images.
6. Perform other operations (e.g. measurement and calculation) if necessary.

5.4.2 M Mode Parameters

„ In M mode scanning, the image parameter area in the upper left corner of the screen
displays the real-time parameter values as follows:

Display V3 IP 6 DR 65 G 45
Parameter M Speed M IP M Dynamic Range M Gain
„ During M mode imaging, you can switch between B and M menu from the menu title.
„ During M Mode scanning, frequency and acoustic power of the transducer are
synchronous with that of B Mode.
„ Adjustment of the depth or TGC to the B Mode image will lead to corresponding changes
in M Mode image.

5.4.3 M Mode Image Optimization

Gain
Description To adjust the gain of M mode image. The real-time gain value is displayed in the
image parameter area in the upper left corner of the screen.

5-8 Image Optimization

Operation Rotate the <Gain/ iTouch> knob clockwise to increase the gain, and anti-
clockwise to decrease.
The adjusting range is 0-100.
Effects Increasing the gain will brighten the image and you can see more received
signals. However, noise may also be increased.

Focus Position
Description To change the focus position in M mode, symbols as " " of which are displayed
on the right of the image.
Operation Adjust the focus position through the [Focus Position] item in the menu.

Time Mark
Description To show the time mark in M mode image.
Operation Turn on or off the function through [Time Mark] item in the menu.
Effects When time mark is displayed on the M mode image, it's much easier to identify
the cardiac cycles and detect more details.
Impacts The function is available in real-time imaging, freeze or cine review status.

Display Format
Description To set the display format of M mode image with B mode image.
Operation Adjust through the [Display Format] item in the menu;
There are 4 formats available for the images display: L/R, V1:1, V1:2, Full.
Effects Adjust according to the actual situation and obtain a desired analysis through
comparison.

Speed
Description This function is used to set the scanning speed of M mode imaging, and the
real-time speed value is displayed in the image parameter area in the upper
left corner of the screen.
Operation Change the speed through the [Speed] item in the menu.
There are 6 levels of scan speed available, the smaller the value the faster the
speed.
Effects Speed changing makes it easier to identify disorders in cardiac cycles.

IP
Description IP is a combination of several image processing parameters ,which is used for a
convenient image optimization. The IP combination number is displayed on the
image parameter area on the right part of the screen.
The M IP combination parameters include dynamic range and M soften.
Operation Select among the IP groups through the [IP] item in the menu.
The system provides 8 groups of IP combinations, and the specific value of
each parameter can be preset.

Image Optimization 5-9

Colorize and Colorize Map
Description Colorize function provides an imaging process based on color difference rather
than gray distinction.
Operation Turn on or off the function through the [Colorize] item in the menu;
Select the colorize map through the [Colorize Map] item in the menu;
The system provides 16 different maps to be selected among.
Impacts The function is available in real-time imaging, freeze or cine review status.

Gray Rejection
Description This function is to reject image signals less than a certain gray scale, then the
rejected signal corresponding area turns black.
Operation Click [Gray Rejection] on the image menu to adjust.
The adjusting range is 0-5.

Curve
Description To manually enhance or restrain the signal in the certain scale.
Operation Click [Curve] in the menu to open the dialogue box to adjust.
Drag the curve node to increase or decrease the gray scale information: drag
the node up to increase the information and down to decrease.

γ
Description The γ correction is used to correct non-linear distortion of images.
Operation Click [γ] on the image menu to adjust.
The adjusting range is 0-3.

Gray Invert
Description Reverse the polarity of the image.
Operation Click [Gray Invert] to turn on or off the image inversion.
Impacts The gray rejection, curve, γ and gray invert functions are available in real-time
imaging, freeze or cine review status.
These post process adjustment will not influence the cine review.

Gray Map
Description Adjusting grayscale contras to optimize the image.
Operation Select among the maps through the [Gray Map] item in the menu.
The system provides 8 gray maps to be selected among.
Impacts The function is available in real-time imaging, freeze or cine review status.

Edge Enhance
Description This function is used to increase image profile, so as to distinguish the image
boundary.

5-10 Image Optimization

Operation Adjust through the [Edge Enhance] item in the menu;
The system provides 14 levels of edge enhance effects, off represents no edge
enhance is turned on, and the bigger the value the stronger the effect.
Impacts Larger edge enhance may lead to noise increasing.

Dynamic Range
Description Adjusts contrast resolution of an image, compresses or expands gray display
range. The real-time dynamic range value is displayed on the image parameter
area in the upper left corner of the screen.
Operation Adjust through the [Dyn Ra.] item in the menu.
The adjusting range is 30-220dB in increments of 5dB.
Effects The more the dynamic range, the more specific the information, and the lower
the contrast with more noise.

M Soften
Description This feature is used to process the scan lines of M images to reject noise,
making the image details to be clearer.
Operation Adjust through the [M Soften] item in the menu;
The system provides 14 levels of M Soften adjustment, the bigger the value the
stronger the effect.

5.5 Image Preset

5.5.1 Image Preset
The image preset is used to set image parameters for a specific transducer in a specific exam
type. The setting methods are similar although parameter items are different in each image
mode.
1. Press <Setup> on the keyboard.
2. Select [Image Preset]Æ[B/THI] to enter the B-mode parameters preset, as shown in the
following figure.

Image Optimization 5-11

3. Select an exam mode and probe.
z Select “ABD” (Abdomen) from the drop-down list of “Exam Mode”.
z Select “35C50EA” (for example) from the drop-down list of “Probe”.
4. Image parameter preset
z The [ABD-- All Probe] field on the left side of the screen displays the parameter
preset for all probes in ABD exam mode.
General Parameter
A.power Drop-down list To set the default acoustic power.
TIC, TIB, TIS, to choose the item to be displayed on the
Thermal index Radio button
screen.
To set the default status of colorize function in B mode,
Colorize Check box
to turn on or off.
Colorize Map Drop-down list To set the default colorize map in B mode.
TSI Drop-down list To set the default TSI mode for B mode.
iTouch Drop-down list To set the default gain of iTouch in B mode.
iTouch Bright Drop-down list To set the default brightness of iTouch.
z The [ABD-35C50EA] field on the right side of the screen displays the parameter
preset for the35C50EA probe in ABD exam mode.
Probe Specific Items
Depth Drop-down list To set the default depth in B Mode.
Frequency Drop-down list To set the default frequency of the transducer.
FOV Drop-down list To set the default FOV in B Mode.

5-12 Image Optimization

 Probe Specific Items
Focus Position Drop-down list To set the default focus position in B Mode.
Focus Number Drop-down list To set the default focus number in B Mode.
To set the default steer angle for the linear probe in
Steer Drop-down list
B mode.
To set if trapezoid function is default to be open for
Trapezoid Check box
linear probe in B mode.
Line Density Drop-down list To set the default line density in B Mode.
B Gain Drop-down list To set the default gain value in B Mode.
THI Gain Drop-down list To set the default THI gain value in B Mode.
B Gray Map Drop-down list To set the default gray map in B Mode.
THI Gray Map Drop-down list To set the default THI gray map in B Mode.
To set the default iBeam value for the linear
iBeam Drop-down list
transducer in B Mode.
To set the default horizontal flipping mode: Left or
L/R Flip Radio button
Right.
To set the default vertical flipping mode: Up or
U/D Flip Radio button
Down.
Rotation Drop-down list To set the default rotate status in B Mode.
To set the default B IP value and you can preset
B IP Drop-down list
each parameter in the button.
To set the THI IP parameters and you can preset
THI IP Drop-down list
each parameter in the button.
High FR Check box To set if high FR is turned on by default.
iClear Drop-down list To set default value of iClear.
5. Click [OK] to exit.
Click [OK] to confirm and exit, or click [Cancel] to exit without saving.

Image Optimization 5-13

6 Display & Cine Review

6.1 Image Display

6.1.1 Splitting Display
The system supports dual-split (B/B) and quad-split (4B) display format. However, only one
window is active.
z Dual-split: press <Dual> key on the control panel to enter the dual-split mode, and
using <Dual> key to switch between the two images; press <B> on the control panel
to exit.
z Quad-split: press <Quad> key on the control panel to enter the quad-split mode, and
using <Quad> key to switch between the two images; press <B> on the control panel
to exit.

6.1.2 Image Magnification

NOTE: Zooming an image changes the frame rate which tends to change thermal indices.
The position of the focal zones may also change which may cause the peak
intensity to occur at a different location in the acoustic filed. As a result, the MI may
change.

6.1.2.1 Spot Zoom

Procedures:
1. Enter zoom:
In real-time image scanning, press <Depth/Zoom> knob on the control panel to light the
Zoom indicator.
2. Adjust ROI:
Roll the trackball to change the box size and position, press <Set> to toggle between
setting the size and position. And after sample volume is set, press <Zoom> key again to
enter spot zoom status.
3. Exit:
In spot zooming status, press <Depth/Zoom> again.
Note:
z Spot zooming only can be realized on a scanning image.
z The size and position of sample volume box will be changed along with scanning
depth and area.

Display & Cine Review 6-1

6.1.2.2 Pan Zoom
Procedures:
1. Enter Zoom:
Freeze the image, press <Depth/Zoom> knob on the control panel to light the Zoom
indicator. Image-in-image is displayed.
2. Rotate <Depth/Zoom> knob to change the magnification factor among 0.8-10.
3. Exit:
z Press <Depth/Zoom>.
z Unfreeze the image, the system exit pan zooming status automatically.

6.1.2.3 iZoom (Full-screen Zooming)

Function: to magnify the image in full screen.
According to the region to be zoomed, the system supports two types of full-screen
zooming:
z Zoom in the standard area to full-screen, including image area, parameter area,
image banner, thumbnail area and so on.
z Zoom in the image area only to full-screen.
„ Procedures:
1. Set the User-defined key:
(1) Press <Setup> to enter [Setup] -> [System Preset] -> [Key Config].
(2) Select a function-free key in the function list.
(3) Select "iZoom" in the "Other" page.
(4) Click [OK] to complete the setting.
2. Open the image(or the under scanning image), press the user-defined iZoom key once to
zoom in the standard image area; and then press the key again to zoom in the image
area only.
3. Press the user-defined key again to return to normal status.
„ The iZoom status supports:
z Measurements, adding comments and body marks.
z Video output, saving image and printing the current area that is zoomed in.
z Exiting the zooming status by pressing <Probe>, <Patient>, <iStation>, <Review> or
<Setup>.

6.1.3 Freeze/ Unfreeze the Image

Press <Freeze> on the control panel to freeze a scanning image. In freeze mode, the probe
stops transmitting acoustic power, and all images as well as the parameters are kept still.
Tip: after freezing an image, the system may enter cine review, measure, comment adding, or
body mark mode, which is dependent upon preset. (Setting path: [Setup]→[System Preset]→
[Image Preset]→"Freeze Config")
Press <Freeze> in freeze mode to unfreeze the image, the system continues image scanning.

6.1.3.1 Imaging Mode Switching When Frozen

Imaging mode switching in freeze mode follows the following principles:
z In splitting display B mode, press <B> to exit splitting display mode and display the
image of the currently activated window in full screen.

6-2 Display & Cine Review

 z In freeze mode, the system supports imaging mode switching between the sub-
modes (only for the activated window).
z The imaging mode and parameters of an unfrozen image is the same as the
corresponding one that before frozen; but the display format is the same as the one
before unfrozen.

6.1.3.2 Imaging Display Format Switching When Frozen

Image display format switching in freezing mode follows the following principles:
„ 2D＋M (Press <Freeze> in 2D＋M scanning mode)
If the imaging mode before frozen is 2D (frozen) +M (real time) or 2D (real time) +M
(frozen), then in freeze mode, you can switch between 2D(real time)+M(real time) or
2D(frozen)+M(real time)) by pressing <Update> key on the control panel.
„ Dual/quad splitting display mode (Press <Freeze> key in dual/quad splitting display mode)
z When enters freeze mode, the default activated window is the real-time window
before frozen. Other image windows display the corresponding cine memories, if a
certain cine memory is empty, then no image is displayed.
z Press <Dual> or <Quad> to switch between dual-splitting and quad-splitting modes.
z Press <B> button on the control panel to enter the single display format, which
displays the currently activated window. In single display format, press <Dual> or
<Quad> to switch between dual-splitting and quad-splitting mode.
z Unfrozen: in splitting display status, when you unfreeze the image you can only
unfreeze the image in the activated window, other images still keep frozen. In single-
window display status, the system displays single image after being unfrozen.

6.2 Cine Review

After you press the [Freeze] key, the system allows you to review and edit the images prior to
the image frozen. This function is called as cine review. The magnified images can also be
reviewed after <Freeze> is pressed, and the operating method is the same. You can perform
post process operations, measurements, adding comments and body marks on the images
being reviewed.
The system supports manual review as well as automatic review. The default mode is Manual
Cine, but you can switch between Auto Cine and Manual Cine.
In addition, the system supports the images reviewed along with physiological waveforms, if
the detection of physiological waveforms is performed.
1. Cine Review images can be inadvertently combined in-
CAUTION: between separate patient scans. The cine memory must be
cleared at the end of the current patient and the onset of the
next new patient by selecting the <End Exam> key on the
control panel.
2. Cine files stored in the system’s hard drive shall contain
patient information, to avoid the selection of an incorrect
image file and potential misdiagnosis.

6.2.1 Entering/ Exiting Cine Review

„ To enter cine review:
z Enter "[Setup]-> [System Preset]-> [Image Preset]-> “Freeze Config”, to set "Status
after Freeze" to be "Cine". Then the system enters the manual cine review status
once press <Freeze> to freeze the image.

Display & Cine Review 6-3

 z Open cine files in thumbnail, iStation or Review, the system enters automatic cine
review status.
„ To exit cine review:
z Press <Freeze> key again, the system will return to image scanning and exit cine
review.
z Press <Cine> or <Esc>, the images are still frozen but the system exits cine review.

6.2.2 Cine Review in 2D Mode

„ Manual cine review
After entering the cine review of 2D mode, rolling the trackball or rotating the
multifunctional knob will display the cine images on the screen one by one.
If you roll the trackball to the left, the review sequence is reversed to the image-storing
sequence, thus the images are displayed in descending order. Whereas, if you roll the
trackball to the right, the review sequence is the same as the image-storing sequence,
thus the images are displayed in ascending order. When the reviewing image reaches the
first or the last frame, further rolling the trackball will display the last or first frame.
The cine progress bar at the bottom of the screen (as shown in the figure below):

Start mark
Cursor Current frame/ Total frames
End mark

„ Auto Review
z Reviewing all
In the manual cine review, click [Auto Play] in the menu to activate auto cine review.
z Setting Region of Auto Review
You can set a segment of cine loop which can be reviewed automatically. After the auto
review region is set, the auto cine review can only be performed within this region; but the
manual cine review can be performed beyond this region. When the cine file is saved,
only the images within this region are saved.
a) Set first frame: Manually review the images until the frame which you want to set it
as start point, then click [Set First Frame] to set a start mark.
b) Set end frame: Manually review the images until the frame which you want to set it
as end point, then click [Set End Frame] to set an end mark.
c) Click [Auto Play] on the image mane.
d) Click [Auto Play] again or roll the trackball to enter manual review status; or press
<Cine> to exit cine reviewing.
e) Click [Skip to First]/ [Skip to Last] to review the first or last image.
Tips: you can perform cine review on each image window in the dual/ quad splitting
mode.

6.2.3 Cine Review in M Mode

After entering the cine review of M mode, rolling the trackball or rotating the multifunctional
knob will display the cine images on the screen one by one.
Roll the trackball to the left, the review progress slider moves to the left, the images moves to
the right, and the earlier stored images are invoked. Whereas, roll the trackball to the right,
the review progress slider moves to the right, and the images move to the left, the recently

6-4 Display & Cine Review

stored images are invoked. When you review the images until the earliest or the latest frame,
further rolling the trackball will display the last or first frame.
The cine progress bar at the bottom of the screen (as shown in the figure below):
 

Start mark
Cursor Time played Time in all
End mark

Cine review operations are the same as those of 2D mode.

6.2.4 Linked Cine Review

The linked cine review refers to review of the images captured at the same moment.
There displays the frame mark on the time mark of M image indicating the current 2D
image.
In dual or quad split display mode, you can only review images of the current active window,
use <Dual> or <Quad> to switch the window.

6.3 Cine Memory

6.3.1 Cine Memory Setting
There are 2 ways of cine memory split: auto and split.
Setting path: select "Auto" or "Split" for cine memory in [Preset]→ [System Preset]→ [Image
Preset].
Where,
z "Auto" for the cine memory indicates the system splits the cine memory as per the
number of B image windows.
z “Split” indicates the system always splits the cine memory, even if in the single-B
window, the system splits the cine memory into two as well. You can press <B> key
to switch and display the images in either memory, so you can compare images in
Split mode.
The memory capacity is evenly distributed as per splitting number, as shown in the following
table (Taking B images in low density as an example, the capacity of B cine memory is N
frames):
Imaging
Mode Single-B Dual Quad
Split
The memory splits The memory splits
One memory, with into two, with into four, with
Auto
capacity N frames. capacity N/2 frames capacity N/4 frames
each each
The memory splits The memory splits The memory splits
into two, with into two, with into four, with
Split
capacity N/2 capacity N/2 frames capacity N/4 frames
frames each each each

Display & Cine Review 6-5

6.3.2 Cine Memory Clear
In the following conditions, the cine review memory will be cleared:
z Start an exam of a new patient.
z Start a new exam for the same patient.
z Switching the probe (if the cine memory is split, only the cine memory corresponding
to the currently activated window is cleared)
z Changing the exam condition (if the cine memory is split, only the cine memory
corresponding to the currently activated window is cleared)
z Imaging Mode Switching: include imaging mode switching among B, M, display mode
switching etc.
z Parameters modification, including:
h Parameters that can result in imaging region or direction changing, such as
depth, FOV, trapezoid, steer, zoom and so on.
h Parameters that can result in image frame changing, such as line density, focus
number and so on.
h Change speed in M mode
h 2D image cleared
z Unfreeze the image: after the image is unfrozen, images stored in the cine memory
will be cleared, but if the cine memory is split, only the currently cine memory
corresponding to the activated window will be cleared.
z Open/ close the image file that occupies cine memory.

6.4 Preset
Open [Setup] →[System Preset]→[General] to preset the cine storage length.

Clip length: 1~60s.

6-6 Display & Cine Review

7 Measurement
There are general measurement and application measurement. You can perform
measurements on a zoomed image, cine reviewing image, real-time image, or a frozen image.
For measurements details, please refer to the [Advanced Volume].
Be sure to measure areas of interest from the most optimal
WARNING: image plane to avoid misdiagnosis from inaccurate
measurement values.

1. If an image is unfrozen or the mode is changed during a

CAUTION: measurement, the calipers and measurement data will be
cleared from the screen. The general measurement data will
be lost (the application measurement data are stored in the
report).
2. If the system is turned off or <End Exam> is pressed during
a measurement, the data not saved will be lost.
3. In Dual-B imaging mode, the measurement results of the
merged image may be inaccurate. Therefore, the results are
provided for reference only, not for confirming a diagnosis.

7.1 Basic operations

„ Entering/Exiting Measurement
Enter: on the control panel, press the <Caliper> to enter general measurement; press
<Measure> key to enter application measurement.
Press <Caliper> or <Measure> key again to exit.
„ Measurement result and help information
The system displays and updates measurement results in the result window.
The help information concerning measurement and calculation is displayed in the Help
Information area at the bottom of the screen.

7.2 General Measurements

7.2.1 2D General Measurements
2D general measurements refer to general measurements on 2D mode:
Measurement Tools Function
Distance Measures the distance between two points of interest.
The distance between probe surface and the probing point along
Depth
ultrasound beam.
Angle The angle between two intersected planes.
Area Measures the area and perimeter of a closed region.

Measurement 7-1
Measurement Tools Function
Volume The volume of a target.
The length of two line segments, which are perpendicular to each
Cross Line
other.
Parallel Line The distance between each pair of parallel lines in a sequence.
Trace Length Measures the length of a curve on the image.
Measures the lengths of any two line segments and the calculated
Distance Ratio
ratio.
Area Ratio The areas of any two regions and the calculated ratio.
The grayscale distribution of ultrasonic echo signals in a closed
B histogram
region.
B profile The grayscale distribution of ultrasonic echo signals across a line.

7.2.2 M General Measurements

M general measurements refer to general measurements on M mode. The measurements
listed below can be performed:
Measurement
Function
Tools
Distance The vertical distance between two points.
Time The time interval between any two points.
Measures the distance and time between two points and calculates the
Slope
slope.
Measures the time of n (n≤8) cardiac cycles and calculates the heart rate in
HR
M mode image.
Calculates the average velocity by measuring the distance and time
Velocity
between two points.

7-2 Measurement
7.3 Application Measurement
The system support following measurement types:
„ Abdomen measurements - Used for measurements of abdominal organs (liver, gall
bladder, pancreas and kidney, etc.) and large abdominal vessels.
„ OB measurements- Used for measurements of fetal growth indexed (including EFW) as
well as GA and EDD calculations. The fetus can be evaluated through growth graph
analysis and fetal biophysical profile.
„ Cardiac measurements- Used for left ventricle function measurements and
measurements of main artery and vein parameters, etc.
„ Gynecology measurements - Used for the uterus, ovary and follicles, etc.
„ Small Part measurements – Used for small parts such as thyroid.
„ Urology measurements - Used for prostate, seminal vesicle, renal, adrenal, micturated
and testicle volume.
„ Vascular measurements – Used for carotid, cerebral, upper and lower extremities vessels,
etc.
„ Pediatric measurements - Used for hip joint measurement.
„ Nerve measurements – Used for nerve structure measurements.
„ Emergency measurements - : Used for emergency abdomen, obstetric, superficial etc.

Measurement 7-3
7.4 Measurement Accuracy
Table 1 Error of 2D Images
Parameter Value Range Error
Within ±3%; or when the measured value is less
Distance Full screen
than 40 mm, the error is less than1.5 mm.
Within ±7%; or when the measured value is less
Area (Trace) Full screen
than 16 cm2, the error is less than 1.2 cm2.
Area (ellipse, Within ±7%; or when the measured value is less
Full screen
circle) than 16 cm2, the error is less than 1.2 cm2.
Angle Full screen Within ±3%.

Table 2 Volume Measurements

Value
Parameter Error
Range
Within ±10 %; or when the measured value is less than 64 cm3,
Volume Full screen
the error is less than 6.4 cm3.

Table 3 Time/Motion Measurements

Parameter Value Range Error
Within ±3 %; or when the measured value is less
Distance Full screen
than 40mm, the error is less than 1.5mm.
Time Timeline Display Within ±2%.
Heart rate Timeline Display Within ±4%.

NOTE: Within the selected field range, the measurement accuracy is ensured within the
range mentioned above. The accuracy specifications are performance in the worst
conditions, or based on the real test for the system, regardless of acoustic speed
error.

7-4 Measurement
8 Comments and Body Marks

8.1 Comments
Comments can be added to an ultrasound image to bring attention, notate or communicate
information observed during the examination. You can add comments to: zoomed image, cine
review image, real-time image, frozen image. You can type the character as comments; insert
the pre-defined comments from the comment library; or insert arrow markers.
You must ensure that the entered comments are correct.
WARNING: Incorrect comments may cause misdiagnosis!

8.1.1 Comment Basic Procedures

1. To enter comment status:
z Press the [Comment] key to enter the comment status, and the cursor becomes “|”.
z Press any alphanumeric key, and the corresponding letter or numeral is displayed
besides the cursor.
z Press the <Arrow> key to enter the arrow-adding status.
Tips: when the system entered comment status, the default characters entered are uppercase.
You can see the <Caps Lock> indicator lights on.
2. Place the cursor to the desired place to set the comment location. Add new comment to
the image according to actual situation. Here, you can modify, move, delete, hide or
display the completed comments.
3. To exit comment status:
z In the comment status, press <Comment> key.
z Or press <ESC> or other operating mode keys, such as [Caliper], [Measure] etc.
z In the arrow-adding status, press the <Arrow> key.

8.1.2 Comment Menu

You can adjust relevant settings in comment status via menu.
„ Display or hide the menu
After entering the comment status, pressing the <Menu> key or the multifunctional knob
will show or hide the Comment Text Library menu.
„ Home of comments
Assign the user-defined key for the set home function in “[Setup] → [System Preset] →
[Key Config]”.
Move the cursor to the desired location for a comment and click the Set-Home user-
defined key. The current position of the cursor is set to be the default position of the
comment adding. When clicking [Home], the cursor will turn to the default setting position.

„ Change Font Size/Arrow Size

z Click [Font Size] to change the font size of comment: Small, Mid, Big.
z Click [Arrow Size] to change the arrow size of comment: Small, Mid, Big.

Comments and Body Marks 8-1

The default is the comment text library in the current exam mode. When entered the comment
status, the system displays the customized comment text library for the current exam. If there
is no customized comment text library for the current exam, it will display the comment text
libraries of all the exam modes assigned for the current probe. And if no text library for all the
exam modes is customized, no comment text will be displayed.
Please refer to “11.6 Comment Preset” for comment preset for the specific exam mode.
„ ABC Display
Click [ABC Display] to display or hide the added comments. Assign the user-defined key
for the function in “[Setup]-> [System Preset]->“Key Config” ”.

8.1.3 Adding Comments

The system can be configured with comment text libraries including Abdomen, Cardiology,
GYN(Gynecology), OB(Obstetrics), Urology, SMP(Small Part), Vascular, PED(Pediatric) and
Nerve Blocks.
„ Typing comment characters
1. To set the comment location:
Roll the trackball or press direction-control keys on the keyboard to move the cursor to
the desired location for comments.
2. To type the alphanumeric characters:
z Type the alphanumeric characters through the qwerty (The default characters are
uppercase);
z To type the upper characters, press [Shift] and the character key at the same time.
3. Move to a new line:
In the edit status (the characters are in green color), press <Enter> to move the cursor to
the new line, and the location of the cursor is aligned with that of the first line.
4. In the edit status, move the trackball or press the multifunctional knob to confirm the
character added, and the color of the character added turns yellow.
„ Adding a Comment Text
Move the cursor onto the desired comment text in the menu and press <Set> or the
multifunctional knob, and then the system adds the selected comment text on the set
location. The added comment text is in the edit status, so you can edit the comment
text added.
z Add combined comment: Press <Menu> or the multifunctional knob to show the
menu; rotate the knob to view the comments one by one; press the knob again to add
the selected item onto the image(comment added in an editable state); rotate the
multifunctional knob to search for the next part, and press the knob again to add the
second part of the combined comment. Repeat procedures to add other parts of a
combined comment. Press <Set> to complete the comment.

„ Adding an Arrow
You can add an arrow to a location where you want to pay attention.
1. Press the <Arrow> key, and an arrow will appear at the default position.
2. Adjust the arrow
z Adjust the position and orientation of the arrow: roll the trackball to the desired
position and use the multifunctional knob to change the orientation in 15° increments.
z Click [Arrow Size] on the menu to change the arrow size:
3. Press <Set> or <Enter> to anchor the arrow position, and then the arrow turns yellow.
4. Repeat the above steps to add more arrows.

8-2 Comments and Body Marks

 5. Press <Arrow> key, <ESC> or to exit the arrow comment status.

8.1.4 Moving Comments

1. Move the cursor onto the comment that needs to be moved. Press <Set> to select it,
where a highlighted box appears around the comment.
2. Roll the trackball to move the comment to the new position.
3. Press the <Set> key to anchor the comment in the new position, and the comment-
moving operation is complete.

8.1.5 Editing Comments

„ Modifying (Editing) characters
1. Move the cursor onto the comment that needs to be modified.
z Directly enter the character at the position that the cursor stays; or,

z Double press the <Set> key to enter the edit status, use the or key to
move the cursor to a location where needs to insert characters, and type characters.
2. Press the <Del> key to delete the comment character or text on the right side of the
cursor; Press the <Backspace> key to delete the comment character or text on the
left side of the cursor.
3. Roll the trackball or press the <Set> key or the multifunctional knob to confirm the
modification and to exit the edit status, and the color of the comments turns yellow.
„ Modifying (Editing) Arrows
1. Move the cursor on the arrow that needs to be modified. After the cursor turns to ,
press the <Set> key. The color of the current arrow turns green, and there is green
frame around the arrow, indicating the arrow can be edited. Move the cursor to
change the arrow position.
2. Rotate the multifunctional knob to modify the arrow direction.
3. Press the <Set> or <Enter> key to complete the modifying operation.

8.1.6 Deleting Comments

„ Deleting Comment Characters, Texts or Arrows
1. Move the cursor to the comment to be deleted.
2. Press the <Set> key to select the comment.
3. Press the <Del> or <Clear> key to complete the deleting operation.
„ Deleting a recently-added character, text or arrow
After you add several comments and the cursor is in the “|” or “ ” status, pressing
<Clear> can delete the recently-added or recently-edited comment.
„ Erase All Text
Long press the <Clear> to delete all the comments.
NOTE: 1. When no object is selected, pressing the <Clear> key will clear all comments
and all measurements calipers.
2. After powering off, the system will clear all comments on the image.

Comments and Body Marks 8-3

8.2 Body Mark
The Body Mark (Pictogram) feature is used for indicating the exam position of the patient and
transducer position and orientation.
The system supports body marks for Abdomen, Cardiology, GYN, OB, Urology, Small Part
and Vascular applications. You can preset the system configured general body marks for each
exam mode, also, you can customize the body mark. For details, please refer to “11.5 Body
Mark Preset”.

8.2.1 Body Mark Operation Procedures

To add the first body mark:
1. Press <Body Mark> to enter the body mark status.
2. Select the body mark, adjust the position and direction of the probe icon.
3. Exit body mark mode.
z Press the <Set> key to confirm the position and orientation of the probe marker and
exit the body mark mode.
z Press [Body Mark] again on the control panel.
z Press the [Esc] key to confirm the current operation and exit the body mark status.

8.2.2 Menu
Press <Menu> to display the body mark menu. You can:
„ Select Bodymark library
Move the cursor to menu title, and select the desired library.
„ Display
Click [Display] to display or hide the body mark added.

8.2.3 Adding Body Marks

„ To add the first body mark:
(1) Enter body mark mode.
(2) Select the bodymark library through the menu title.
(3) Select the bodymark.
Move the cursor onto the desired bodymark to highlight your choice, and press <Set>
to add the selected bodymark; or rotate the multifunctional knob to view the
bodymarks.

(4) Press <Set> to confirm the selection.

(5) To adjust the probe position and orientation marker:
z Roll the trackball to place the probe marker at the correct position.
z Rotate the multifunctional knob to adjust the orientation.
z Press the <Set> key to confirm the position and orientation of the probe marker and
exit the body mark mode.

8-4 Comments and Body Marks

8.2.4 Moving Body Marks
You can move the body mark graphic to any desired position within the image area.
1. Roll the trackball to move the cursor onto the body mark. The cursor changes into ,
indicating you can move the pictogram to a new position.
2. Press <Set> key to select the body mark, and a frame will appear around the graphics.
3. Roll the trackball to move the Body Mark graphic to the desired position.
4. Press <Set> to anchor and confirm the new graphics position.
NOTE: In Dual B Mode, a body mark cannot be moved between the separated image
windows.

8.2.5 Deleting Body Marks

„ To delete a body mark
1. Use the trackball to position the cursor on the body mark graphic and Press <Set> to
select.
2. Press <Clear> to delete the selected body mark.

NOTE: In the Body Mark mode, if no object is selected, pressing the [Clear] key will
clear all comments, body marks and general measurements from the screen.
Tips:
z Powering off, preset returning, switching the exam/ patient/ mode/ probe will clear the
body marks.

Comments and Body Marks 8-5

9 Patient Data Management
An exam record consists of all information and data of one exam.
An exam record consists of the following information:
z Patient basic information and exam data
z Image files
z Report
NOTE: 1. DO NOT use the internal hard drive for long-term image storage. Daily
backup is recommended. External storage media is recommended for
image archive.
2. The system patient database space is limited, please back up or clear
patient data in time.
3. Mindray is not responsible for lost data if you DO NOT follow suggested
backup procedures.

9.1 Patient Information Management

9.1.1 Enter Patient Information
The general patient information and exam information are entered through the Patient Info
screen, for details, please refer to “4.2 Patient ”.
After completion of patient information entry, click [OK] to save the patient information to the
patient data.

9.1.2 Patient Information Setting

Open “[Setup] → [System Preset] → [General]”, and then set the following in the Patient Info
area. Here, you can select if to display patient gender, age or operator in the screen; set the
H&W applied unit and select the using surface formula.
z Patient information display
z H&W Unit
z Surface formula

Patient Data Management 9-1

9.2 Image File Management
You can store the image files either in the patient database in the system, or to external
memory devices. For a save image, you can perform operations like image reviewing,
analyzing and demonstration (iVision).

9.2.1 Storage Media

System supported memory media including:
z System hard disk
z USB memory devices: USB flash drive, removable USB hard disk
z DVD±RW, CD-R/W

9.2.2 Image File Formats

The system supports two types of image file formats: system-relevant and PC-compatible.
„ System-relevant formats:
z Single-frame image file (FRM)
Refers to single-frame static image files not to be compressed; you can perform
measurements and comments adding on this type of files.
z Cine file (CIN)
System-defined multi-frame file format; you can perform manual or auto cine review,
and perform measurements or add comments for the reviewed images. After you
open a stored CIN file, the system automatically enters cine review status.
The system can save FRM files as BMP, JPG, TIFF or DCM files, or save CIN files as AVI,
DCM files. The system can also open FRM, JPG, BMP and CIN files.
„ PC-compatible formats:
z Screen file (BMP)
Single-frame file format, used to save the current screen, non-compressed format;
z Screen file (JPG)
Single-frame file format, used to save the current screen in the compressed format;
you can set the compression ratio.
z TIFF: Single-frame export format
z Multi-medium files (AVI)
Multi-frame file format, general cine file format.
z DICOM files (DCM)
DICOM standard files format, single-frame or multi-frame format, used to record
patient information and images.

9.2.3 Image Storage Preset

„ Set image size
You can set the image size via [Setup] →[System Preset]→ [General]. The items are
shown as follows:

9-2 Patient Data Management

„ Set single frame export format
z Format
You can select the image export format in the Send To dialogue box.
NOTE: Compression in a JPEG format may result in image distortion.

„ Set cine saving length

For details, please refer to “6.4 Preset”.

9.2.4 Saving Images to the System

„ To save a single-frame image in the system:
(1) Enter [Setup]-> [System Preset] -> [Key Config]-> [Output], set a user-defined key for
function “Save image to hard drive”.
(2) Press the user-defined key to save the image.
z In the image screen, press the shortcut key to save the current single-frame image
with the image frozen, and the image is saved with the default filename in the default
file directory in the FRM format. The thumbnail of this image will appear in the
thumbnail area on the right side of the screen. When you move the cursor onto the
thumbnail, its filename with suffix will be displayed.
z When a dialog box is displayed on the current screen, press the user-defined key to
save the screen in the BMP format.
„ To save cineloop image in the system:
(1) Enter [Setup]-> [System Preset] -> [Key Config]-> [Output], set a user-defined key for
function “Save cine”.
(2) Freeze an image. Click the user-defined key to save the current image file in the
default file directory in the dynamic image format .CIN.
The thumbnail of this image will appear in the thumbnail area on the lower side of the
screen. When you move the cursor onto the thumbnail, its filename with suffix will be
displayed.

9.2.5 Quickly Saving Images to USB Flash Drive

Use user-defined keys to quickly save the single-frame or cine to USB flash drive.
The image file is stored in the directory: U disk\ US Export\ patient folder\ exam folder\ Image
ID.bmp, here,
z Patient folder name: patient name+ patient ID
z Exam folder name: exam mode+ exam time
„ To store single-frame image to USB flash drive:
(1) Set the user-defined key through the path: [Setup]→ [System Preset]→ [Key Config].
Select a key in the Key Function page on the left side and select “Send image to USB
disk” in the Output page of Function field on the right side.
(2) Return from Preset to the main screen.
(3) Press the user-defined key to save the image to the USB flash drive.
„ To store cine to USB flash drive
Save cine images to a USB flash drive in the AVI format.
(1) Set the user-defined key through the path: [Setup]→ [System Preset]→ [Key Config].
Select a key in the Key Function page on the left side and select “Send AVI Cine to
USB disk” in the Output page of Function field on the right side.
(2) Return from Preset to the main screen, scan and freeze an image.

Patient Data Management 9-3

 (3) Press the user-defined key to save the cineloop.

9.2.6 Quickly Saving Full Screen Image to the System

This function can save the current full screen image to the system with the image in real-time
status.
1. Set the user-defined key through the path: [Setup](by pressing <Setup>)→ [System
Preset]→ [Key Config]. Select a key in the Key Function page on the left side and select
“Send Full Screen Image to hard drive” in the Output page of Function field on the right
side.
2. After the setting, you can use the user-defined key to save full screen image to the
system.

9.2.7 Thumbnails
The stored images or cineloops are displayed in the form of thumbnails on the screen:
z In the iStation screen, the thumbnails refer to the images stored for the selected
exam or the selected patient.
z In the scanning or freeze mode, the thumbnails refer to the images stored in the
current exam.
z In the Review screen, the thumbnails refer to the images stored in the same exam.
z In the Review screen, open an image to enter the image analyzing status, all the
thumbnails belong to the exam are displayed.
z When you move the cursor onto a thumbnail, its name and format will be displayed.

9.2.8 Image Review and Analysis

You can review and analyze the stored images (only refer to the images stored in the system
default path).

9.2.8.1 To review images

You can review all images stored in an exam, and send, delete or analyze the stored images.
„ To enter Review:
z Press <Review> to enter Review screen. The system display the images stored in
this exam of the current patient (if there is no current patient information, you can
review the images of the latest exam).

z Select an exam of a patient in the iStation screen, and click to enter the Review
screen to review the images of the patient. You can also select more than one exam,
and the system will display images of the lately exam images in Review status.
The Review screen is shown as follows:

9-4 Patient Data Management

„ To exit Review:
z Click [Exit] on the Review screen; or,
z Press <ESC> or <Review> again.
„ Basic operations
Move the cursor onto an exam item in the Exam History area and press <Set>. The
selected item is highlighted. Click [Info] or [Report] to view patient information or report.
Double-click a thumbnail to view and analyze an image. Rotating the Multifunctional knob
will navigate through thumbnails.
The function buttons are described as follows:
z Exam History:
You can select one certain exam from the exam directory to review the images.
h If entered from iStation, the screen displays the record(s) selected in the iStation.
If no patient is selected when it was in iStation, then all the patients in the system
database will be displayed, and the current patient exam is listed.
h If entered from the imaging status, the Review screen displays the images of the
current exam, and the default selected image is the one displayed on the
preview main screen.
z Info:
Click to enter the Patient Info screen, you can review or edit the currently-selected
patient information.
z Report
Click to review or edit the currently-selected patient report.
z Image operations
[Select All]: click to select all images in the thumbnail window.
[Deselect All]: after clicking the [Select All], the button changes into [Deselect All], you
can cancel all the selections by clicking [Deselect All].
[Send To]: click to send the selected image to other location, DICOM server, printer
and etc. Or, select the image and click .

Patient Data Management 9-5

 [Delete]: click to delete the selected image. Or, select the image and click .
z Thumbnail Size
Small: 4x4
Middle: 2x2
Full: 1x1
z Switching operations:
[New Exam]: click to create a new exam for the selected patient and open the Patient
Info screen.
[Activate Exam]: click to enter the currently selected exam and enter the image
scanning screen; it grays out if the current patient cannot be activated.
[iStation]: click to enter the iStation screen.
[Exit]: click to exit the Review status, and return to the main screen.

9.2.8.2 To analyze images

For the image analysis, you can view, zoom, perform post processing and measurements,
add comments and perform cine (multi-frame) review for a stored image. The operation steps
are the same as those for real-time scanning; please refer to relevant sections for details.
„ To enter image analysis:
z In the image scanning or freeze status, double-click a thumbnail stored in this exam
to enter the image analysis status; or
z Double-click the selected thumbnail to open the image.
„ To exit the image analysis:
z Press <Freeze> or click [Exit] to exit and enter the real-time scanning status.
z Press <Review> to exit from the image analysis to the Review status.
In image analysis status, the selected image is open on the screen, and the thumbnails of
the same exam are displayed on the Thumbnail area, you can turn the pages, delete or
send a selected image.

9.2.9 iVision
iVision function is used for demonstration of the images stored. Image files are played
according to file names one by one (including the image of system-relevant and PC-
compatible format).
To perform image demonstration:
1. Enter iVision screen:
Enter image menu-> [Advanced], select [iVision]; or, press the user-defined key for iVision
on the control panel (setting path: [Setup]→[System Preset]→[Key Config]).
2. Add the contents to be played and select the demo mode.
3. Select an item in the list, and click [Start] to begin the demonstration.
4. Click [Exit] or press <ESC> to exit the iVision status.
The iVision screen is shown as follows:

9-6 Patient Data Management

„ Demonstration item
The demonstration items are the image files in the formats that the system supports. You
can add the exam data in patient database or system supported image files and folders to
demonstration list. For files and folders in demonstration list, the images in the directory
and subdirectory are played one by one, and the system will automatically jump over the
files that can’t be opened.
„ Demonstration item
There are two kinds of catalogs: Demo Catalog and Customize Catalog.
z Demo Catalog: demo catalog is the folder in hard disk(E disc), where the factory
DEMO is stored. The system plays the images in this folder when performs
demonstration.
The system supports import, delete or clear the data in demo catalog.
Click [Demo Manager] to operate:
[>]: to import data to demo catalog.
[<]: to delete the selected data.
[<<]: to delete all data.
z Customize Catalog: what saved here is the catalog of the displayed image. The
system plays the images in the catalog when performs demonstration.
Operate the catalog by the buttons on the right:
[Add File]: to add files to the file list.
[Add Catalog]: to add catalog to the file list.
[Delete]: to delete the selected file or catalog in the file list.
[Clear]: to clear all the files or catalogs in the file list.

„ Demonstration mode
Interval: refer to the interval time for demonstration, the adjusting range is 1~500s.

Patient Data Management 9-7

„ Option of Demo
You can choose whether to repeat the demonstration or exit after a demonstration is
completed.

9.2.10 Sending Image File

„ On the image screen, select a stored image thumbnail, click (Send To) on the right
corner of the image, the image can be sent to the external device, DVD recorder, DICOM
storage server, DICOM print server, system connected printer and etc.
„ In the iStation screen, click ; or, in Review screen, click [Send To] to send the selected
image to the external devices.
See the figure below.

z For external memory devices (e.g. USB memory devices, DVD or iStorage server):
a) PC format transfer: JPG/ AVI, BMP/ AVI, TIFF/ AVI. Where a single-frame image
is exported as JPG, TIFF or BMP, and the cine file exported as AVI.
b) DCM format transfer: DCM( including single-frame DCM and multi-frame DCM).
c) You can also select to export report in RTF format.
z For DICOM Storage or Print server, select the DICOM Storage or Print server.
z For a video printer, send images to the video printer connected with the system. For
a graph/ text printer, send the images to the default graph/ text printer.

9.3 Report Management

„ Report storage:
The exam reports are stored under the directory of the exam of the patient.

9-8 Patient Data Management

„ Importing, exporting and sending a report

In the iStation screen, select patient data, click (Restore) or (Backup) to import or
export patient information, images and reports from or to an external memory device. See
the following figure:

In the iStation screen, click ; or, in Review screen, click [Send To] to send patient data
to an external memory device, you can choose if reports are exported with images. See
the figure below.

To export the report:

(1) Check “Export Report” on the screen.
(2) Click [OK] to confirm.
You can select paper size for the report in the path: [Setup] → [Print Preset]

Patient Data Management 9-9

„ Printing report
Use a connected graph/text printer to print a report. Please refer to “11.7 Print Preset” for
details about default report printer setting.
For details on report relevant operations, please refer to [Advanced Volume].

9.4 Patient Data Management (iStation)

The patient data include basic patient information, exam information, image files and reports.
You can search, view, backup, send, restore or delete patient data in iStation.
„ To Enter iStation
z Press <iStation> key on the control panel; or
z Click [iStation] in the Patient Info screen; or
z Click [iStation] in the Review screen.
The iStation screen is shown as follows:

Viewing Patient Information

„ Data Source
Select the data source of patient data, the system patient database is default.
„ Patient List
Display patient information, exam mode, number of images and cines, exam state,
backed up or not.

„ New Exam:
After you select a patient data or exam in the iStation screen, click the [New Exam] to
enter the Patient Info screen, where you can select a new exam mode and click [OK] to
begin a new exam.

9-10 Patient Data Management

„ Select All Exams/ Deselect All Exams
Click [Select All Exams] to select all patient data listed. Then the button changes into
[Deselect All Exams], you can cancel all the selections by clicking [Deselect All].

9.4.1 Searching a Patient

(1) Select the data source.
(2) Set search conditions of Name, ID, DOB, Exam Date in the "Item" drop-down list.
(3) Enter the keyword in accordance with the “Item” selected, and the system searches
and displays the results in the patient list.
(4) When you select a patient in the patient list, the images of this patient will be
displayed at the bottom of the screen.
Note:
z When you clear the keyword, enter other keyword or cancel the selection “Find in
results”, the system will refresh the searched results.
z Select “Find in results”, the system will do searching based on the last searched
results.

9.4.2 Patient Data View & Management

Select the desired patient information in the list. The following menu pops up:

„ Review

Select an exam of a patient, click to enter Review screen.

„ Info:

Select an exam of a patient, click on the right side to display the

patient information of this exam.
„ Report

After you select an exam of a patient, click to view the report of this
exam for this patient. If no report is generated in the exam, the system prompts that
“There is no report belongs to the exam”.
„ Delete

Select an exam or a patient, click to delete. However, you cannot

delete patient data being printed, exported or sent, or delete the current exam.
To delete an image, select the image and click on the right side.
„ Backup/ Restore
You can back up the selected patient data to the system-supported media in order to view
it on PC, or restore the patient data to the system from an external media.

Patient Data Management 9-11

 : Backup. Click to export the selected patient data to the system-
supported media.

: Restore. Click to import the patient data from an external media. If

no external data source is connected, then the button is unavailable.

„ Send To
The system supports to send data to external memory devices or print.

z Select the patient record, click in the menu to send exam data or
images of the selected record.

z Select the image, click to send the selected image.

h Send patient exam data to USB devices, DVD drive or iStorage server.
h Send images to USB devices, DVD drive, DICOM storage server, DICOM printer,
video printer, text/ graph printer or iStorage server.
h Send images with report to USB devices, DVD drive or iStorage server.
h Format transfer is available when sending images to USB devices, DVD or
iStorage server. See "9.2.10 Sending Image File" for details.
h Press <Shift> on the control panel to select more than one exam or image at one
time.

„ Activate exam
After you select an exam, which has been performed within 24 hours, click
to activate the exam and load the basic patient information and
measurement data to continue the exam.
If you want to select a patient data in an external memory database to start a new exam
or recover the exam, you have to first allow the system to load the patient data to the
system’s patient database.
„ Continue Exam

Select an exam that is paused within 24 hours, click to activate

the exam and load the basic patient information and measurement data to continue the
exam.
If you want to continue an exam which data lies in an external memory database, you
have to first allow the system to load the patient data to the system’s patient database.
„ Recycle bin
The recycle bin is used to store the deleted patient data, exam data and images (time
lasts from deleting to system is powered off). The system supports recovery of those data
from the recycle bin. NOTE: The recycle bin will be cleared after the system is powered
off.
To recover the deleted patient data, click at the lower right corner of the screen
(when the button is gray, the operation is unavailable) to enter the Patient Recycle Bin
screen.
(1) Select items to be recovered in the list.
(2) Select operations:
z Click [Restore Items] to restore the item back to iStation;
z Click [Delete] to delete the item permanently, and the item can never be restored
again;
z Click [Restore All Items] to restore all the items back to iStation;

9-12 Patient Data Management

 z Click [Empty Recycle Bin] to empty the recycle bin and all items can never be
restored again.
Click [Exit] to exit Recycle Bin screen and return to iStation.

9.5 Backing Up and Erasing Files through

DVD Drive
The system supports DVD-RW to write data in CD/DVD and to read data from CD/DVD in PC.
Support media: DVD±RW, CD-R/W.
„ To write data to a CD/DVD:
(1) Put a CD/DVD in the tray.

(2) Select the data to be backed up, click or in

the screen (in iStation or Review). Select the target drive in the Send To or Back Up
Patient Record dialogue box.

(3) Click or [OK] to start writing with the symbol displays .

(4) After the writing process is completed, click to pop up the Disc Option dialogue
box, and select [Eject] to eject the CD/DVD.

„ To erase data from a CD/DVD

(1) Put the CD/DVD in the tray.

(2) Double-click the symbol to pop up the [Disc Option] screen, as shown in the
figure below.
(3) Click [Erase] to erase data from a CD/DVD;
(4) After the erasing process is completed, click [Eject] in the Disc Option dialogue box.
Note:
z Writing data using “Send To” supports PC format transfer function, while CD/DVD
written by “Backup” supports only system-relevant formats.

z The symbol indicates that the input CD/DVD is damaged or with data of wrong
format.
During the backup process, if a CD/DVD is forcibly taken out
CAUTION: or you perform other operations, the backup process will fail
or the system may malfunction.

NOTE: Directly removing a DVD-RW/DVD+RW drive may result in the damage of drive
and/or the system, please refer to “3.6 Connecting/ Removing a USB Storage
Device” for disconnection.）

Patient Data Management 9-13

9.6 Patient Task Manager
Click at the lower right corner of the screen to pop up the following dialogue box:

Including:
„ Storage Task: displays the DICOM storage task.
„ DICOM Print Task: displays the DICOM print task.
„ Media Storage Task:
z DICOM media storage task(including disc and USB devices)
z Backup task (system-relevant format): select the exam to be backed up in iStation
and click .
z Send to external devices (including disc and USB devices): select exam data or
images in iStation or Review screen, click or [Send To].
z IStorage task.

„ Print Task
List of the current printing task. Displays the file name, status (printing or suspended),
printer name, submit time etc.
If all print tasks are finished, the print icon will disappear from the screen, if not, please
check the manager to see if there is any failure task.

In the Task Management dialogue box, patient ID, name, destination, progress, type, status,
content and task created time are displayed.
You can do the following operations:

9-14 Patient Data Management

„ Delete
Click [Cancel] to cancel the selected task.
„ Retry
Click [Retry] to retry the failed task. When the printer ran out of ink or paper, tasks in print
list will be paused. Click [Retry] to continue the paused print task.
„ Select All
Click [Select All] to select all the tasks.
„ Task Status
Select the undergoing task, the system will display its detailed status information or error
information.

When there is/are task(s) undergoing, the task management icon displays as , you
can click the icon to check the process.

When there is/are task(s) failed, the task management icon displays as , you can
click the icon to check the failure reason.

When the task management icon displays as , it means no task is undergoing or

failure.
„ DICOM Service Setting
Click [Service Setting] to enter DICOM preset. See section 10.3 DICOM Service.

9.7 Access Control

9.7.1 Access Setting
The system support user type of:
„ Administrator
The system administrator can view all patient data, such as patient information, image
and report, etc.
„ Operator
The operator can only view the exam information saved in the system and operated by
himself or herself, such as patient information, image and report, etc. The operator cannot
view the exam data operated by others.

Emergency operators are general ones, they can enter the system without entering
password. But they can’t modify or delete the password.

9.7.2 Setting Access Control

The system administrator can preset the access control, that is, if an operator has the right to
access to the data in the system.
The access control only can be set by the system administrator.
Setting access control:
1. Open the “Admin” page through the path: [Setup]→[System Preset]→[Admin].
2. If [Enable User Account Control] is selected, you need to login before accessing system
data. If unselected, you can access all the data without the authority.

Patient Data Management 9-15

9.7.3 System Login
If [Enable User Account Control] is selected, you can access the data in the system only after
you login the system.
You need to enter user name and password in the following cases:
z Before entering the system
z Changing user
As long as the system is in working status, you can enter the above screens without inputting
user name and password repeatedly. You need to login again after system restart or
dormancy.
„ Login the system:
(1) If the system requires you to log on the system before you access the data, you can
see the following dialogue box.

(2) Select the user name in the drop-down list of User Name.
(3) Enter password and click [Login].

For emergency users, click [Emergency] directly to log on.

„ Changing user
(1) To log out the current user and change to another user, click at the lower right
corner of the screen to pop up the following dialogue box:

(2) Click [Change User] to pop up the Login dialogue box.

(3) Enter the user name and password in the field box.

9.7.4 Add/ Delete a User

The system administrator can add and delete a user, while the operator can’t.

9.7.4.1 Add a User

Premise: you must login the system as the system administrator. If not, you will be required to
enter administrator name and password before the setting.
1. Open the “Admin” page through the path: [Setup]→[System Preset]→[Admin]. See the
figure below.

9-16 Patient Data Management

2. Click [Add] to enter the following page.

3. Enter the user name(you are not allowed to enter the same name or modify the name
already exist).
4. Enter user name and the password.
5. Set the user role in the drop-down list: administrator or operator.
6. Click [OK] to confirm the setting and exit the dialogue box, then the new user will appear
on the User List.

9.7.4.2 Delete a User

Premise: you must login the system as the system administrator. If not, you will be required to
enter administrator name and password before the setting.
1. Open the “Admin” page through the path: [Setup]→[System Preset]→[Admin].
2. Select the user to be deleted in the User List (Emergency user can’t be deleted), click
[Delete] to delete the selected user.

Patient Data Management 9-17

9.7.5 Modify Password
The system administrator can modify password of all users. The administrator password by
factory is empty, you can set the password for it. The operator can only modify his/her own
password.
To modify the password, the user has to login the system first.
There are two ways to modify password: modify it on “Admin” page or on “Session Manage”
dialogue box.
„ “Admin” page (administrator can modify the password)
(1) Open the “Admin” page through the path: [Setup]→[System Preset]→[Admin].
(2) Select the user name to be modified (except emergency operator) in User List, click
[Change Password].
(3) Enter new password and confirm password in the dialog, then click [OK].
„ Session Manage page(general operator and administrator can modify the password).
When the user has logged on the system, you can see at the lower right corner of the
screen.
(1) Click at the lower right corner to pop up the Session Manage dialogue box, on
which you can see the current user’s information.
(2) If you want to modify the current password, click [Change Password] to pop up the
Change Password dialogue box.

(3) Enter the previous and the new password in the dialogue box.
(4) Click [OK] to exit.

9-18 Patient Data Management

10 DICOM
NOTE: Before using DICOM, please read the electronic file DICOM CONFORMANCE
STATEMENT along with the device.
This chapter is confined to the preset, connection verification and DICOM services of the
DICOM-configured ultrasound machine, not including SCP configurations like PACS/ RIS/ HIS.
The DICOM package is optional, so the description here is only applicable for the system
configured with the DICOM package.
This system supports the following DICOM functions:
z DICOM Basic functions: DICOM verify connectivity, DICOM task management,
DICOM storage, DICOM print, DICOM storage commitment, DICOM media storage
(DICOMDIR review)
z DICOM Worklist
Workflows of DICOM preset and application are briefly described as follows:
1. DICOM preset (network preset, DICOM preset and DICOM service)
2. Verify connection.
3. DICOM Services (image storage, print, Worklist, storage commitment, media storage,
DICOMDIR review, task management).
Abbr. used in this chapter:

Abbr. Descriptions
Digital Imaging and Communications in
DICOM
Medicine
AE Application Entity
PDU Protocol Data Unit
SCU Service Class User (DICOM client)
SCP Service Class Provider (DICOM server)
SOP Service-Object Pair

10.1 DICOM Preset

10.1.1 Network Preset
NOTE DO Not edit IP address in Network Preset page as the network task is executed,
otherwise it fails. View if there is any undergoing task in task manager of the system.
Preset local TCP/IP settings.
1. Press <Setup> to enter the [Setup] menu.
2. Select [Network Preset].

DICOM 10-1
3. Local TCP/ IP preset items are described as follows:
Name Description
Current Net Adapter To select network connection mode.
DHCP DHCP: IP address will be automatically obtained from DNS server;
/ Static Static: you need to enter the IP address.
IP Address IP address of the system.
Subnet Mask Used to set different network segment.
Gateway Used to set the gateway IP.
Note:
z The IP address of the system should not be occupied by other devices in the network,
or the DICOM function will fail.
z After you changed “Station Name”, you need to restart the system to make the setting
effective (press the power button and select “Shut Down” and restart the system after
a while).

10.1.2 DICOM Preset

To set the DICOM service and server properties.

1. Press <Setup> to enter the [Setup] menu.

2. Select [DICOM Preset].

10-2 DICOM
3. Preset local DICOM properties and DICOM server.
„ Localhost DICOM Service Property
Name Description
Application entity title of the ultrasound system.
AE Title The AE title here should be the same with the one of the acceptable
SCU set in the server.
DICOM communication port, which should be the same with the one
Port
in the server.
Maximum PDU data package size ranging from 16384 to 65536.
PDU
The default value is 32768.
Enter AE Title, Port, PDU according to the actual situation, and then click [OK] to exit the
screen.
Note:
z AE Title should be the same with the SCU AE Title preset in the server (PACS/ RIS/
HIS), for example, if the AE Title of the server preset in the print server is AAA, and
the AE Title of the accepted SCU is preset as MMM, then in the figure above, the AE
Title of Local should be MMM, and the AE Title of print server should be AAA.
„ DICOM Server Setting
Name Description
Device Name of the device supporting DICOM services.
IP Address IP address of the server.
You can ping other machines to verify connection after entering the
Ping correct IP address. Also you can check the connection of the
already added server in the list.

DICOM 10-3
 Name Description
[Add] Click to add servers to the device list.
[Set DICOM Service] Click to enter DICOM service preset, see “10.1.3 DICOM Service”.
[Delete] Click to delete the selected server (s) in the device list.
Note:
z If the currently entered name has already existed, the system will pop up: “The server
name exists!” Click [OK] to enter another name.

10.1.3 DICOM Service

When the system is configured with DICOM basic function module, and installed DICOM
Worklist and Storage Commitment, the corresponding preset settings can be found in DICOM
Service screen.

Enter [Setup]-> [DICOM Preset], Click [Set DICOM Service], you can add, delete and set the
property of the service on DICOM server.

10.1.3.1 Storage
1. Enter [Setup]-> [DICOM Preset]-> [Set DICOM Service]-> [Storage].
2. Select device, enter the information. For device setting, please refer to “10.1.2 DICOM
Preset.”
z Click [Add] to add the service to the Service list;
z Select an item in the service list, change the parameters in the above area, and click
[Update] to update the item in the service list; click [Cancel] to cancel changing.
z Select an item in the service list, and click [Delete] to delete the service.
z Select an item in the service list, and click [Default] to set the server to be the default
service.
3. Select an item in the service list, and click [Verify] to verify the connection.
4. Click [Exit] to save and exit the preset.

10-4 DICOM
DICOM storage setting items are described as follows:
Name Description
After you set the server (s) in DICOM Server Setting, the name
Device (s) will appear in the drop-down list, select the name of the
storage server.
Service Name Default is xxx-Storage, and it can be modified.
Application Entity title, Here, it should be consistent with that of
AE Title
the storage server.
DICOM communication port, 104 by default. Here, the port should
Port
be consistent with that of the storage server port.
Maximum Retries Range: 0-9.
Interval Time(s) Reserved feature.
Refers to time after which the system will stop trying to establish
Timeout a connection to the service. Value: 5－60s, in increments of 5s,
and 15 by default.
Color Mode Gray/ Mixed/ Color
Select the compression mode: uncompressed, RLE, JPEG and
Compression Mode
JPEG2000.
Compression Ratio Select the compression ratio: lossless, low, medium and high.
Allow Multiframe If SCP supports this function, then select it.
[Add] Add the DICOM service to the service list.
[Cancel] Click to cancel the parameter setting.

DICOM 10-5
 Name Description
Select an item in the service list, change the parameters in the
[Update] above area, and click [Update] to update the item in the service
list.
[Delete] Click to delete the selected service in the service list
Select an item in the service list, click [Default] and you can see
[Default]
“Y” in the Default column.
Click to verify if the two DICOM application entities are normally
[Verify]
connected.
[Exit] Click to exit the screen.
Tips: RLE, JPEG and JPEG2000 are not supported by all SCPs. Please refer to the electronic
file DICOM CONFORMANCE STATEMENT of the SCP to check whether SCP supports or not.
Do not select these compression modes if the storage server doesn’t support them.

10.1.3.2 DICOM Print

1. Enter [Setup]-> [DICOM Preset]-> [Set DICOM Service]-> [Print].
2. Select device, enter the information. For device setting, please refer to “10.1.3 DICOM
Service.”
z Click [Add] to add the service to the Service list;
z Select an item in the service list, change the parameters in the above area, and click
[Update] to update the item in the service list; click [Cancel] to cancel changing.
z Select an item in the service list, and click [Delete] to delete the service.
z Select an item in the service list, and click [Default] to set the server to be the default
service.
3. Select an item in the service list, and click [Verify] to verify the connection.
4. Click [Exit] to confirm the setting and exit the page.

10-6 DICOM
DICOM print setting items are described as follows:
Name Description
After you set the server (s) in DICOM Server Setting, the
Device name (s) will appear in the drop-down list, select the name
of the print server.
Service Name Default is xxx-Print, and it can be modified.
Application Entity title. Here, it should be consistent with that
AE Title
of the print server.
DICOM communication port, 104 by default. Here, the port
Port
should be consistent with that of the print server port.
Maximum Retries Range: 0-9.
Interval Time(s) Reserved feature.
Refers to time after which the system will stop trying to
Timeout establish a connection to the service. Value: 5－60s, in
increments of 5s, and 15 by default.
Refer to copies of printed files. You can select among 1
Copies
through 5, or directly enter the number.
The system supports RGB(color printing) and
Settings MONOCHROME2 (black and white printing). Please select
the type the printer supports.
Film Orientation Select between LANDSCAPE and PORTRAIT.
Priority Specify printing task priority among HIGH, MED and LOW.
Select film size among the selections listed in the drop-down
Film Size
list.
Specify quantity of printed files,e.g. STANDARD\2, 3
Display Format
indicates 6 images are printed for each page.
Medium Type Specify print medium: Paper, Clear Film, Blue Film.
Specify whether you want a trim box to be printed around
Trim
each image on the film: Yes or No.
Min Density Enter the minimum density of the film
Max Density Enter the maximum density of the film.
Configuration Info Enter configuration information in the field.
Specify where the file is exposed:
Destination MAGAZINE (stored in the magazine), or
PROCESSOR (exposed in the processor)
Replicate: interpolated pixels belong to duplicate of adjacent
pixels;
Bilinear: interpolated pixels are generated from bilinear
interpolations between adjacent pixels;
Magnification Type
Cubic: interpolated pixels are generated from cubic
interpolations between adjacent pixels; None: without
interpolation.
Select how the printer magnifies an image to fit the film.

DICOM 10-7
 Name Description
[Add] Add the DICOM service to the service list.
[Cancel] Click to cancel the parameter setting.
Select an item in the service list, change the parameters in
[Update] the above area, and click [Update] to update the item in the
service list.
[Delete] Click to delete the selected service in the service list.
Select an item in the service list, click [Default] and you can
[Default]
see “Y” in the Default column.
Click to verify if the two DICOM application entities are
[Verify]
normally connected.
[Exit] Click to exit the screen.
Parameter setting should be consistent with the printer performance:
z For instance, if the printer cannot support film size to be “8IN*10IN”, please select the
printer supported size.
z Settings: RGB is color printing and MONOCHROME2 is black and white printing.
z Medium Type: for black and white printing, usually Blue Film or Clear Film is used,
and for color printing, Paper is usually used. For details, please refer to printer
conformance statement.
z Change the setting if necessary.

10.1.3.3 DICOM Worklist

1. Enter [Setup]-> [DICOM Preset]-> [Set DICOM Service]-> [Worklist].
2. Select device, enter the information. For device setting, please refer to “10.1.3 DICOM
Service.”
z Click [Add] to add the service to the Service list;
z Select an item in the service list, change the parameters in the above area, and click
[Update] to update the item in the service list; click [Cancel] to cancel changing.
z Select an item in the service list, and click [Delete] to delete the service.
z Select an item in the service list, and click [Default] to set the server to be the default
service.
3. Select an item in the service list, and click [Verify] to verify the connection.
4. Click [Exit] to confirm the setting and exit the page.

10-8 DICOM
DICOM service setting for Worklist is described as follows:
Name Description
After you set the server (s) in DICOM Server Setting screen, the
Device name (s) will appear in the drop-down list, select the name of the
Worklist server.
Service Name Default is xxx-Worklist, and it can be modified.
Application Entity title, Here, it should be consistent with that of
AE Title
the Worklist server.
DICOM communication port, 104 by default. Here, the port should
Port
be consistent with that of the Worklist server port.
Maximum Retries Reserved feature.
Interval Time(s) Reserved feature.
Refers to time after which the system will stop trying to establish
Timeout a connection to the service. Value: 5－60s, in increments of 5s,
and 15 by default.
[Add] Click to add the Worklist service to the service list.
[Cancel] Click to cancel the parameter setting.
Select an item in the service list, change the parameters in the
[Update] above area, and click [Update] to update the item in the service
list.
[Delete] Click to delete the selected service in the service list.
Select an item in the service list, click [Default] and you can see
[Default]
“Y” in the Default column.

DICOM 10-9
 Name Description
Click to verify if the two DICOM application entities are normally
[Verify]
connected.
[Exit] Click to exit the screen.
Note:
In terms of “Scheduled Station AE Title”, if you set this item in the Worklist server, then
“Scheduled Station AE Title” configured here should be consistent with the one set in the
server.
For example, when you set “Scheduled Station AE Title” in the Worklist server as DP50 (this
means you assigned the scheduled exam to DP50), then both “Scheduled Station AE Title”
and “AE Title” in the ultrasound system configuration should be DP50.

10.1.3.4 Storage Commitment

1. Enter [Setup]-> [DICOM Preset]-> [Set DICOM Service]-> [Storage Commitment].
2. Select device, enter the information. For device setting, please refer to “10.1.3 DICOM
Service.”
z Click [Add] to add the service to the Service list;
z Select an item in the service list, change the parameters in the above area, and click
[Update] to update the item in the service list; click [Cancel] to cancel changing.
z Select an item in the service list, and click [Delete] to delete the service.
z Select an item in the service list, and click [Default] to set the server to be the default
service.
3. Select an item in the service list, and click [Verify] to verify the connection.
4. Click [Exit] to confirm the setting and exit the page.

DICOM storage commitment setting items are described as follows:

10-10 DICOM
 Name Description
After you set the server (s) in DICOM Server Setting, the name
Device (s) will appear in the drop-down list, select the name of the
storage commitment server.
Service Name Default is xxx-SC, and it can be modified.
Application Entity title, Here, it should be consistent with that of
AE Title
the storage commitment server.
DICOM communication port, 104 by default. Here, the port
Port should be consistent with that of the storage commitment server
port.
Maximum Retries Reserved feature.
Interval Time(s) Reserved feature.
Value: 5－60s, in increments of 5s, and 15 by default. After image
Timeout storage commitment is sent, the system will close the connection
with the server.
The associated storage server is preset before storage
Associated Storage
commitment, only after the exam is sent out, can storage
Service
commitment be created.
[Add] Add the DICOM service to the service list.
[Cancel] Click to cancel the parameter setting.
Select an item in the service list, change the parameters in the
[Update] above area, and click [Update] to update the item in the service
list.
[Delete] Click to delete the selected service in the service list
Select an item in the service list, click [Default] and you can see
[Default]
“Y” in the Default column.
Click to verify if the two DICOM application entities are normally
[Verify]
connected.
[Exit] Click to exit the screen.

10.2 Verify Connectivity

If you want to verify connectivity (not a must), you can click [Verify] button on the pages of
DICOM Service screen respectively.
z If the verification succeeds, it will prompt “xxx Verify Succeed”.
z Otherwise, it prompts “xxx Verify Failed”.
If verification failed, the possible causes may be:
z The ultrasound machine can’t communicate normally with the server. Please check if
the cable is properly connected; or,
Check if the IP of the server is configured in the same segment with that of the
ultrasound machine; or,
Check if the network adapter, the router, the exchanger or the HUB are normally
working.
z The server does not support the verification. If the connection is normal, it can be
concluded that the server does not support the verification.

DICOM 10-11
 z The server supports the verification, but this function is not activated. Please check if
the verification function is activated.
Note:
Not all the SCPs can support verification; please consult SCP belongings to confirm whether
SCP can support this service. If not, the verification won’t pass.

10.3 DICOM Service

If the system is configured with DICOM modules, and connected to the relevant DICOM
servers, after verifying connection, you can perform storage, print, Worklist, storage
commitment, and query/ retrieve applications.

10.3.1 DICOM Storage

DICOM Storage is used to send image(s) to DICOM storage server for storage.
„ Send image in iStation/Review/main screens
(1) Select image(s)
z Press <iStation> to enter the iStation screen, click to select an exam record in the list,
where thumbnails are displayed in the thumbnail area in the lower part of the screen,
and then click to select a thumbnail or several thumbnails. Or,
z Press <Review> to enter the Review screen, click to select an image or several
images. Or,
z On the main screen, select a thumbnail or several thumbnails.
(2) Select a saved image in the iStaion, Review or main screen, and click on the right
side of the image. The following dialogue box pops up:

(3) Select DICOM in the “Target” list, select a server in the “Storage Server” list.
(4) Click [OK] to start the sending.

10-12 DICOM
10.3.2 DICOM Print
DICOM Print is used to send image(s) to DICOM print server to print images.
„ Print image in iStation/Review/main screens
(1) Select image(s), operations are the same with DICOM storage.
(2) In the Send To dialogue box, select a DICOM print server.

(3) Click [OK] to send print task.

10.3.3 DICOM Worklist

After successfully connected DICOM Worklist server with ultrasound system, you can query
patient records from Worklist server, and then import the desired information to your system.
„ To query patient information via Worklist server:
(1) Press <Patient> to enter Patient Info screen.
(2) Click [WorkList] to enter the WorkList page.

DICOM 10-13
 (3) Retrieve Patient Information
a) Set query criteria among Patient ID, Patient Name, Accession #, Search Key,
Worklist Server or Exam Date. The default exam date is the current date.
b) Click [Query].
c) The scheduled patients, which meet the criteria, are displayed in the lower part of
the screen.
d) After the first query, you can perform the second query based on the preview
results. The scheduled patients in the list will update in real time.
(4) Select the desired patient record in the displayed patient list, and
Select the desired patient and click [Start Exam], the patient information is imported
into the system and then an exam is started.
Click [Transfer], the patient information is imported into the Patient Info screen. Edit
the patient information in the Patient Info screen, and select [OK] to start a new exam.
(5) To show patient information in details:
a) Click to select a patient record.
b) Click [Show Detail] to view the detailed patient information and properties.
„ Use the automatic query function via Worklist server
(1) Enter DICOM Service Preset screen, and open the Worklist page: [Setup]→[DICOM
Preset]→[Set DICOM Service]→“Worklist”.
(2) Select an item in the service list, and click [Default] to set the server to be the default
service.
(3) Click [Exit] and click [Return] in the Setup menu.
(4) Press <Patient> to enter Patient Info screen.
(5) Click [WorkList] to enter the WorkList page.
(6) The system queries intraday patients via Worklist server automatically and the patient
records will appear in the list.
In the off-line status, you can:

10-14 DICOM
„ Perform a second query; or,
„ Click [Show Detail] to view the patient information in details:

10.3.4 Storage Commitment

Storage commitment is used to make sure the images are successfully stored in the DICOM
server.
Before storage commitment, you should set a default storage commitment server.
„ Storage commitment after sending images on iStation screen
(1) Open iStation screen: press <iStation> or press <Patient> and click [iStation].

(2) Select an exam record (image (s) is/are stored in the exam record), click to
open the Send To dialogue box.
(3) Click to select “DICOM” in the “Target” box on the left side, then select the DICOM
storage server in the “Storage Server” box on the right side.
(4) Click [OK] to start sending. The system will send all the images stored in the exam
record to the storage server, meanwhile, it will send storage commitment to the
storage commitment server.

10.4 DICOM Media Storage

The system supports to save patient data to the external media in DCM format. Meanwhile, in
the system, you can view the saved DCM files from external media
„ Media storage:
1. Select patient record(s) in the iStation screen.

2. Click , the following dialog box popped up:

3. Select the destination, and select DICOM format.

4. Set whether to remove patient exam data or only images from the local hard disk.
5. Click [Backup] to begin storage.
If the backup succeeded, there will be a tick marked in the Backup list in iStation screen;
otherwise, no tick is marked.
Tips: There should be no DICOMDIR/ DICMIMG/IHE_PDI files in the external storage
media of the same name with the one being backed up, otherwise, the backup
can’t proceed. Please make sure there is enough storage space; otherwise,
backup may fail due to space shortage.

DICOM 10-15
„ Media review:
1. Connect the external media with DCM files to the system.
2. Select the data source in iStation screen, and the visible data will be shown.
If there are several kinds of data on the media, the system will ask you to select the format
from a dialog box.

„ Data Restore:
1. If the DICOM format data is backed up to external media, you can restore the data to the
system from the media.
2. Review the data stored in the external media.
3. Select the data to be restored in iStation.

4. Click in the iStation screen.

NOTE: Only the system accessible media can be selected.

10.5 DICOM Task Manager

DICOM Task Management is used to view task progress or manage tasks after sending
images for storage, print, or media storage.
For details on tast manager, see 9.6 Patient Task Manager.

10-16 DICOM
11 Setup
The Setup function is designed to set the configuration parameters of operating the system
and maintaining user workflow setup data. The setup data of the user and system are stored
to the hard drive, and should be backed up to CD/DVD or USB memory devices.
When the setup data is changed, be sure to save the preferences
CAUTION: according to the methods described in this chapter. Mindray is
not responsible for the loss of the setup data.
„ To enter Setup:
z Press the <Setup> to enter Setup;
z On probe& exam mode selection page, click [Exam Preset] to enter Exam Preset
page.

„ To exit Setup:
Selecting [Return] on the Setup menu, or press <Esc> to close the Setup menu, and the
parameter settings is saved.
If you change the system language and click [Return] on the Setup menu or press <ESC>,
the system will automatically restart to make the changing effective.
„ Basic operations
The commonly-used setting types are:
z Manually inputting: posit the cursor into the corresponding box, enter the desired
value through keyboard.
z Radio button: Click the button to select an item.
z Check box: click the check box to select one or several options.
z Drop-down list: click the arrow beside the list to select an item.
„ General buttons
z [OK]: click to confirm the setting, exit the current page and then return to the previous
page.
z [Cancel]: click to give up the setting, exit the current page and then return to the
previous page.

Setup 11-1
 z [Load Factory]: click [Load Factory], and all parameter settings will be restored to the
original factory default.

11.1 System Preset

Click [System Preset] on the Setup menu, you can preset:

Page Description
To set the hospital name, language, time zone, time format, system
Region
date/time, logo and so on.
To set patient information, exam setup, patient management, storage,
General
system dormancy, operation log and so on.
Image Preset To set some general parameters in imaging modes.
Meas To set the measure ruler, measure result, units and so on.
To set the relevant information about fetal gestational age, fetal growth
Obstetrics
formula and fetal weight.
Key Config To assign functions to footswitch and <Print>, <Save>, <F1> ~<F6>.
To set the needle-guided bracket model and biopsy guide line relevant
Biopsy
parameters.
Admin To set the user account control relevant information.

11.1.1 Region
Open the Region page via [Setup]-> [System Preset]-> [Region], as shown in the figure below.

11-2 Setup
 Item Description
To set the hospital relevant information like name, address, telephone
Hospital Information
and so on.
To select a language for the system, the available languages are
Chinese, English, French, German, Italian, Portuguese, Russian,
Spanish, Polish, Czech, Turkish, Finnish, Danish, Icelandic,
Language Norwegian, and Swedish.
The system will restart automatically after you change the language
and return from the Setup menu.
Time Zone To select the time zone.
To set the date format among DD/MM/YYYY, MM/DD/YYYY and
Date Format
YYYY/MM/DD.
Time Format To select the time format between 12Hour and 24 Hour.
To set the system date.
Posit the cursor into the corresponding field, and enter the data
System Date
through the keyboard; or, click the calendar icon , and then select
the date.
Enter time to the text box; or modify the time via spinner buttons on
System Time
the right side.

11.1.2 General
Open the General page via [Setup]-> [System Preset]-> [General], as shown in the figure
below.

Setup 11-3
 Type Item Description
To select if to display the following patient information on
Info displays in
the image banner: Gender, Age, Operator, ID, Name,
image banner
Hospital
Patient Info
H&W Unit To set the unit for patient height and weight.
Surface Formula To set the surface formula.
To set the size for a stored image:
Image Area
Image Size
Standard Area
Storage
Full Screen
Clip length/ Time (s) Times: 1~60s
Output Mode PAL/ NTSC
To enable screen saver function, and select the waiting
Screen Enable ScreenSaver
time until screen saver.
Saver
Enable Standby Available after “Enable ScreenSaver” is selected.
Color temperature Cold/ Warm
Display Brightness/Contrast Load the factory data of the display brightness and
Load Factory contrast.
Font size Small/ Medium/ Large
Arrow Size Small/ Medium/ Large
Comments Clear comments
while unfreezing To set if clear comments while unfreezing an image or
image or changing changing probe/exam
probe/exam

11.1.3 Image Preset

Open the Image Preset page via [Setup]-> [System Preset]-> [Image Preset], as shown in the
figure below.

11-4 Setup
 Type Item Description
Reset Config Probe To set the default probe model for the system.
Freeze
Status after Freeze To set the system status after image is frozen.
Config
Image Cine Memory To set the cine memory splitting type: Auto, Split.

11.1.4 Meas
Open the Meas page via [Setup]-> [System Preset]-> [Meas]. Through the page, you can set
the measure ruler, unit and relevant information. For details, please refer to the Operator’s
Manual [Advanced Volume]

11.1.5 OB
Open the OB page via [Setup]-> [System Preset]-> [OB]. Through the page, you can set the
gestational age formula, fetal growth formula, fetal weight formula and the relevant
information. For details, please refer to the Operator’s Manual [Advanced Volume].

11.1.6 Key Config

Open the page via [Setup]-> [System Preset]-> [Key Config], as shown in the figure below.

Setup 11-5
„ Key function setting
You can set the functions for <Print>, <Save>, F-key (F1-F4) and footswitch.
To assign a function to a key:
(1) Click to select the desired key in the Key Function column at the left side of the page.
(2) Click to select a function in Function area. You can see the functions selected at the
right side of the select key.
(3) Click [OK] to complete function setting.

The following introduces an example as setting <F4> as “Save AVI Cine to USB disk”:
(1) Select F4 in the “Key Function” list at the left side of the page.
(2) Select “Save AVI Cine to USB disk” in “Function” at the right side of the page.
(3) Click [OK] to complete the setting.
„ Other Settings
Item Description
Key Lightness To set the lightness for the keys: 0, 1, 2, 3.
Key Volume To set the key volume: 0-2, 0 means no sound.
To set the trackball speed when move the trackball: Slow,
Trackball Speed
Medium, Fast.
To set the color for the trackball: White, Blue, Green, Pink,
Trackball Lightness
Purple, Yellow.

11-6 Setup
11.1.7 Biopsy
Open the Biopsy page via [Setup]-> [System Preset]-> [Biopsy], as shown in the figure below.
„ Bracket
To select the default needle-guided bracket for the probe.
„ Parameter
Press to display the biopsy guideline.

11.1.8 Admin
Open the Admin page via [Setup]-> [System Preset]-> [Admin].
For details of access control, please refer to “9.7 Access Control”.

11.2 Exam Preset

Open [Setup]-> [Exam Preset] or click [Exam Preset] in the “Probe & Exam” selection screen
to enter Exam Preset screen.

11.2.1 Exam Selection

After the Exam Preset screen is entered, the screen will display the Exam Selection page, as
shown in the figure below. This page is used to assign an exam type to a specific probe.
1. To select a probe:
Move the cursor to [Probe], and select a probe from the drop-down list.
2. Selecting/delete exam modes

Setup 11-7
 On the right side of the screen, you can view the exam types supported by the current
probe. On the left side, you can view all the exam modes supported by the system, i.e.,
Exam Library.
z [>]: add a selected exam mode in the [Exam Library] to the [Exam Selected] list.
z [>>]: add all exam modes in the library to the [Exam Selected] list.
z [<]: remove an exam mode selected from the [Exam Selected] list.
z Click [Up] and [Down] to adjust the sequence of the items in Selected Items.
z Click [Default] to set a selected exam mode as the default exam mode.
3. Click [OK] to confirm the modified setup; or click [Cancel] to cancel the modified setting.

11.2.2 Exam Configuration

In the Exam Preset screen, click “Exam Config” page tab to enter Exam Config page.

The system supports:

„ Copying Exam Mode
1. Select an exam mode you want to copy from the list.
2. Click [copy].
3. Select another exam mode and click [Paste]. The parameters in the source exam
mode are copied to the target exam mode (target exam mode will not be renamed).
Tips: loading or pasting exam setup data will overwrite previous presets and can't be reverted.
Exercise caution for this operation.
„ User-defined Exam Modes
You can create a user-defined exam mode by Duplicating an exam mode existed:
1. Select the exam mode you want to copy, and click [Duplicate].
2. Input a new name in the dialog box popped up, and click [OK].

11-8 Setup
Tips: the user-defined exam mode supports duplicating, deleting, renaming, copying and
pasting functions.

„ Renaming Exam Mode (available to user-defined exam mode only)

Select an exam mode, click [Rename].
„ Changing application region (available to user-defined exam mode only)
Select an exam, click the application region from the [Application] column, select a value
from the drop-down list.

11.3 Image Preset

Enter [Setup]-> [Image Preset].
Image preset is used to set the image parameters for each imaging mode.
Image parameters can be divided into the following three categories:
„ Imaging mode relevant parameters
„ Parameters pertinent to both exam mode and probe.
„ Other image specific parameters

For details, please refer to the relevant imaging modes in “5 Image Optimization”.

11.4 Measure Preset

For measurements details, please refer to the Advanced Volume.

11.5 Body Mark Preset

In order to accommodate your workflow – numerous preferential settings can be captured in
Body Mark Preset. This function is to preset, body marks in each exam type, or user-defined
body marks.

11.5.1 Preset Body Mark for Exam Mode

1. To enter Body Mark Preset screen(see the figure below):
Enter [Setup]-> [Bodymark Preset] (as shown in the figure below).

Setup 11-9
2. Selecting exam modes
Select the exam mode in the drop-down list, the current exam mode is by default.
3. Set library: enter the library name of custom body marks.
4. Add or delete body mark(s)
To add the item selected from the [Available Items] into the [Selected
[>]
Items].
[>>] To add all items from the [Available Items] into the [Selected Items].
To remove the selected item in [Selected Items] to the [Available
[<]
Items].
[<<] To remove all items from the [Selected Items].

5. Click [Up] and [Down]: to adjust the sequence of the items in Selected Items.
6. Preset the probe mark of the selected body mark in Selected Items
Move the cursor onto the probe mark of the body mark in Probe area and press <Set> to
make the cursor turn green. Roll the trackball to change the position of the probe, rotate
the multifunctional knob to change the angle, and press <Set> to confirm the orientation
of the probe.
7. Select the body mark in Selected Items and click [Default], and then the body mark will be
prior to be displayed.
8. Click [OK] to complete the setting.

11.5.2 Custom Body Marks

The system supports loading and deleting body marks.
Click [Import Custom] in the Body Mark Preset screen above, enter the user-defined body
mark screen (as shown in the figure below).

11-10 Setup
„ [Load File]: load a single body mark file.
„ [Load Directory]: load all body mark files located in a directory specified.
„ [Return]: exit the current screen.

11.6 Comment Preset

You can preset the custom comments library for each exam mode to your preference.

11.6.1 Custom Comments

You can preset the custom comments library for each exam mode to your preference. The
comments in the library are provided by the system or user-defined ones. The name of the
library, which can be set, will appear on the first page of the library.
1. To enter Comment Preset:
Open the Comment page via [Setup]-> [Comment Preset].

Setup 11-11
2. Select exam mode.
3. Enter Library Name: you can enter characters for the library name, or accept the default
name (the same as that for the exam mode).
4. Add user-defined comments: directly enter comment texts, or select comment texts for
the comment library.
z Directly enter comment texts: posit the cursor in the field box above [Add Comment],
enter the text comment through the keyboard, and then click [Add Comment]. Then
the directly-entered comment will be added to the Available Items and Selected Items.
z Select Available Items: First select a comment library in the drop-down list beside
“Available Items”, and then click [Set] on one item displayed below “Available Items”.
h Click [>] to add the item in Available Items on the left into Selected Items on the right.
h Click [>>] to add all items in Available Items on the left into Selected Items on the
right.
5. Change position of the selected items: select an item on the right side box and click [Up],
[Down], [Left] or [Right] button to change the position of the item.
6. Delete comments:
z Remove item (from the library or user-defined) in the Selected Items list:
Select an item in Selected Items list, and click [<] to remove it to the Available Items list.
Click [<<] to remove all items in Selected Items.
z Delete a user-defined item in the Available Items box. You can only delete the user-
defined items rather than the items in the system library. After a user-defined item is
deleted, it will not be available.
Select a user-defined item in the Available Items box, and click [Delete]. After the
user-defined item in the Available Items box is deleted, the same item in the Selected
Items box on the right will disappear as well.
7. After you customize comments, click [OK] to confirm and exit the [Comment Preset]
screen.

11-12 Setup
11.7 Print Preset
The settings of a printer include print service and print driver.

z Print Service Setting

h Add Service: click to begin print service adding.
h Remove Service: click to delete the selected print service.
h Rename Service: click to rename the selected print service.
h Property: to preset the property of print services.
z Printer Driver Setting
Printers listed in the operator’s manual are all supported by the system, no drive is
required.
Click [Print Driver] page to enter printer driver setting screen:
h Display the printer name as well as print status.
h You can add printer including network printer.
h Check the printer attribute.
For details about DICOM print, please refer to “10 DICOM”.

Setup 11-13
11.8 Network Preset
„ For local TCP/IP preset and DICOM preset, please refer to “10.1 DICOM Preset”.
„ The IStorage screen is as follows:

Name Description
Service Name Name of the device, cannot be empty
IP address of the PC installed with iStorage software, cannot be
IP Address
empty
Press to verify connection with the PC server. On PC server, if the
storage path has not been confirmed, a dialog box will pop up and
Connect guide the user to set it. If the storage path on PC has already been
set, here it displays connection successful after clicking this button.

Add Click it to add the new service to the service list.

Update To save the changed parameters.
Delete Click to delete the selected service in the service list.

„ Add a network service:

1. Set the network server properties as described above.
2. Click [Add] to add the service to the Service list;
3. Select the added service in the service list, you can delete it.
„ Modify a network service:
1. Select the service to be updated in the service list.
2. You can see properties in the Configure Service area.
3. Modify the parameters and click [Update] to update setting.

11-14 Setup
Tips: in order to make network storage function normally, setting of the sharing folder of the
PC server in advance is a must, e.g. machine name, IP address, should be confirmed at first.

11.9 Workstation Preset

You can preset to send the image and measurement data to Workstation, which is an image
data management system.
„ Workstation Preset
Enter [Setup]-> [Workstation Preset] to set the IP Address and Port.
„ User-defined key Preset
Enter [Setup]-> [System Preset]-> [Key Config]-> [Other] to preset a user-defined key for
sending image and measurement data to the workstation. For details on key configuration,
see « 11.1.6 Key Config ».

11.10 Manage Settings

The Manage Settings page is used to import or export the setup data or restore factory setup
data.

11.10.1 Exporting Setup Data

This function is used to write all setup data of the system into a disk for backup. The format of
the data file is PDP.
„ To export some of preset data

1. Enter [Setup]-> [Manage Settings], select some items in the [Export] field on the left.
2. Click [Export] to open the [Export Data] screen.
3. Select the path to save the data.
4. Click [OK].
„ To export all preset data
Click [Export All], select the path to save the data.

11.10.2 Importing Setup Data

This function is used to import the existing setup data to the setup data memory of the system.
The system will reset and operate according to the setup preferences that were imported.
„ To import some of preset data

1. Enter [Setup]-> [Manage Settings], select an item in the Import field on the right.
2. Click [Import] to open the Load Data screen.
3. Select the imported file.
4. Click [OK], a progress bar will appear and the setup data in DTA format is imported to the
specified path.
5. To restore the factory setup data, click [Restore Factory] on the right side of the screen.

Setup 11-15
„ To import all preset data
Click [Import All], select the path to save the data.

11.11 Maintenance
The [Maintenance] function is designed for you to update the system software or other special
functions. If you require these functions, please contact Mindray Customer Service
Department or sales representative.
You can manage preset data, export and upload operation logs here.

11.12 System Information

Click [About] in the Setup menu to enter the system information screen. (The information
varies depending upon the system configurations and version.) ）
„ About
Lists product name, hardware version and other information, which is uneditable but can
be export as txt file by clicking [Save].
„ About Detail
Lists version information of the software, hardware and other modules, which are also
uneditable but can be export as txt file by clicking [Save].
„ Option
Lists option module information.

11-16 Setup
12 Probes and Biopsy
12.1 Probe
The system supports the following probes: 
No. Probe Model Probe Type Illustration

1. 35C50EA Convex

2. 65C15EA Convex

3. 65EC10EA Intra-cavity

4. 75L38EA Linear array

Probes and Biopsy 12-1

 No. Probe Model Probe Type Illustration

5. 75L53EA Linear array

6. 10L24EA Linear array

7. 65EB10EA Convex

 
Note: For details of storage time and condition for disinfected probes or sterilized probes
and brackets, please refer to Technical standard for Disinfection of Medical and Health
Structures
 

12.1.1 Name and Function of Each Part of the

Transducer
Basic structures and functions of all probes listed above are similar, and are described as
follows.

12-2 Probes and Biopsy

„ Probe 35C50EA
<2>

<1>
<3>

<4>

<5>

   
No. Name Function
It converts the electrical signal into ultrasound signal,
making the sound beams focus in the given direction;
meanwhile, it will receive the ultrasound signal and then
<1> Transducer head convert the received signal into electrical signal.
The lens on the surface is the acoustic lens. Apply
ultrasound gel on the acoustic lens.
Needle-guided
<2> bracket fix tabs and Used to mount the needle-guided bracket.
grooves
Used to transmit electrical signals between the transducer
<3> Transducer cable
body and connector.
Used to connect the transducer to the ultrasonic diagnostic
<4> Transducer connector
system.
This locks the connector to the ultrasonic diagnostic
<5> Lock handle
system.
The probes’ structure marked <2> in the figure above may vary with the matched needle-
guided brackets. 
„ Probe 65EB10EA

<3>
<2> <4> <5>
<1>

<6>

Probes and Biopsy 12-3

No. Name Function

It utilizes the piezoelectric effect to convert electrical

<1>Transducer head signals into ultrasound waves, which are transmitted
<1> (convex, vertical section) to the body, and to generate electrical signals when
<2> <2>Transducer head receiving the reflected ultrasound waves (echoes).The
(convex, horizontal section) lens on the surface is the acoustic lens. Apply
ultrasound gel on the acoustic lens.

<3> Locating groove Mount the needle-guided bracket.

This transmits electrical signals between the

<4> Cable
transducer body and connector.

This connects the transducer to the ultrasonic

<5> Connector
diagnostic system.

This locks the connector to the ultrasonic diagnostic

<6> Lock handle
system.

12.1.2 Orientation of the Ultrasound Image and the

Transducer Head
The orientation of the ultrasound image and the transducer are shown below. The “MARK”
side of the ultrasound image on the monitor corresponds to the mark side of the transducer.
Check the orientation before the examination (take linear probe as an example).

Orientation mark

Mark

12-4 Probes and Biopsy

12.1.3 Operating Procedures
This section describes general procedures for operating the transducer. The proper clinical
technique to be used for operating the transducer should be selected on the basis of
specialized training and clinical experience.
„ Procedures for operating (with biopsy function)

Inspection before examination

Connection to the ultrasonic

diagnostic system

Examinations

Biopsy procedure

Disconnection to the ultrasonic

diagnostic system
Sterilization of the needle-
guided bracket

Wiping off the ultrasound gel

Inspection after use

Washing the transducer with water

Storage

Draining/drying

Immersion into disinfectant

Removing the transducer

from disinfectant

Rinsing the transducer in sterile water

Draining/drying

Inspection after use

Storage

Probes and Biopsy 12-5

„ Procedures for operating (with no biopsy function)
Inspection before examination

Connection to the ultrasonic

diagnostic system

Examinations

Disconnection to the ultrasonic

diagnostic system

Wiping off the ultrasound gel

Washing the
transducer with water

Draining/drying

Disinfection

Immersion into disinfectant

Removing the transducer

from disinfectant

Rinsing the transducer into sterile water

Draining/drying

Inspection after use

Storage

Disinfect the probe and sterilize the needle-guided bracket

before and after an ultrasound-guided biopsy procedure is
WARNING: performed. Failure to do so may cause the probe and the
needle-guided bracket become source of infection.

12-6 Probes and Biopsy

12.1.4 Utilizing the Transducer Sheath
A transducer sheath must be installed over the transducer before performing examination.
Probe sheaths are available for use with all clinical situations where infection is a concern.
A probe sheath must be installed over the probe before performing intra-cavity or biopsy
examination. Use a commercially available transducer sheath.
To order transducer sheath, contact:
CIVCO Medical Instruments Co.
102 First Street South, Kalona, IA 52247-9589 USA Tel: 1-319-656-4447
E-mail: info@civco.com
http://www.civco.com
1. Be sure to cover the probe with a new (unused) probe sheath
CAUTION: to prevent infection during examination. If the package of a
probe sheath is open or broken, the sterilization of the probe
sheath may not be sufficient. DO NOT use such a probe
sheath.
2. The cover contains natural rubber latex and talc that can
cause allergic reactions in some individuals.
3. DO NOT use an expired probe sheath. Before using probe
sheaths, verify whether the term of validity has expired.

Method (for reference only):

1. Place an appropriate amount of gel inside 2. Insert the transducer into sheath making
the sheath or on transducer face. Poor sure to use proper sterile technique. Pull
imaging may result if no gel is used cover tightly over transducer face to remove
wrinkles and air bubbles, taking care to
avoid puncturing cover.

3. Secure the sheath with enclosed elastic 4. Inspect the sheath to ensure there are no
bands. holes or tears.

Probes and Biopsy 12-7

12.1.5 Probes Cleaning and Disinfection
After completing each examination, clean and disinfect (or sterilize) the probes as required.
When biopsy procedures have been performed, be sure to sterilize the needle-guided bracket.
Fail to do so may result in the probe and the needle-guided bracket to becoming sources of
infection. Please follow the instructions in the manual for cleaning.

WARNING: Never immerse the probe connector into liquid

such as water or disinfectant. Immersion may
cause electrical shock or malfunction.

1. When performing cleaning and

CAUTION: disinfection of the probe to prevent
infection, wear sterile gloves.

2. After disinfection, rinse the probe thoroughly with sterile

water to remove all chemical residues. Chemical residues on
the probe may be harmful to the human body.
3 No cleaning and disinfecting may result in the probe
becoming a source of infection.

NOTE: 1. After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the
ultrasound gel may solidify and degrade the image quality of the transducer.
2. DO NOT make the probe to become overheated (more than 55°C) during
cleaning and disinfections. High temperature may cause the probe to become
deformed or damaged.

Cleaning
Please refer to the instructions in the manual and follow your hospital policy and procedures
for cleaning.
1. Disconnect the probe from the system.
2. Wear sterile gloves to prevent infection.
3. Wash the transducer with clean water or soapy water to remove all the foreign matters, or,
wipe the transducer with a soft ethyl carbamate sponge. Avoid using a brush, because it
may damage the transducer.
4. Dry the transducer using a sterile cloth or gauze after rinsing. Do not dry the transducer
by heating it.

Disinfecting with Sprays

Use protective eyewear when disinfecting using sprays.
CAUTION:
1. Wear sterile gloves to prevent infection.
2. After you have finished cleaning, spray the transducer with a disinfectant. Follow the
disinfectant manufacturer’s recommended contact time and mode.
3. Remove any residue with a water-moistened soft cloth on the transducer.
4. Wipe off water on the transducer using sterile cloth or gauze after washing.

12-8 Probes and Biopsy

 Connector

Strain relief

NOTE: Observe the graph here carefully to perform disinfection. Do not spray the strain
relief on the connector end or the connector.

Disinfecting by Immersion
1. Wear sterile gloves to prevent infection.
2. Clean the transducer before disinfecting it.MINDRAY recommends the following solutions
to disinfect the transducer.
z Refer to the instructions provided by the chemical manufacturer concerning
concentration of the disinfectant solution, method of disinfection and dilution and
cautions during use.Do not soak the transducer connector or the cable near it into
water or any solution.
z Soak the transducer into the disinfectant solution for the shortest time the
manufacturer recommends (for example, the shortest time recommended by the
manufacturer for soaking Cidex OPA is 12 minutes).
z Follow local regulations when selecting and using the disinfectant.
3. Rinse the transducer with plenty of sterile water (about 2 gallons) for at least 1 minute to
remove all chemical residues on it.Or, follow the rinsing method recommended by the
disinfectant manufacturer to rinse the transducer.
4. Wipe off the water on the transducer with sterile cloth or gauze after rinsing it.Do not dry
the transducer by heating.

Probes and Biopsy 12-9

 Strain relief
Probe handle

NOTE: Observe the graph here carefully to immerse the transducer. Only soak parts of the
transducer below the strain relief.

Compatible Disinfectants
Manufacturer Trade Name Procedures Type
Please refer to the instructions
Pharmaceutical provided by the manufacturer Spray
T-Spray II
Innovations, Inc. of the solution for details.

PROTEXTM Please refer to the instructions

Parker Laboratories provided by the manufacturer Spray
DISINFECTANT
Inc. of the solution for details.
SPRAY
Please refer to the instructions
Metrex MetriZyme provided by the manufacturer Solution
of the solution for details.
Please refer to the instructions
Cidex Activated
ASP provided by the manufacturer Solution
Dialdehyde Solution
of the solution for details.
Please refer to the instructions
ASP Cidex OPA provided by the manufacturer Solution
of the solution for details.

TrophonSonex-HL
Please refer to the instructions
(Used with Trophon
Nanosonics Limited provided by the manufacturer Solution
EPR Ultrasound
of the solution for details.
Probe Disinfector)

12-10 Probes and Biopsy

12.1.6 Storage and Transportation
When all examinations for the day have been completed, confirm that the transducer is in
good condition. After disinfecting the transducer, confirm that the transducer is in good
condition and store it in a suitable place so that the next examination can be conducted
smoothly.
1. To prevent the transducer from being damaged, do not store it in locations where it may
be exposed to:
z Direct sunlight or X-rays
z Sudden changes in temperature
z Dust
z Excessive vibration
z Heat generators
2. Store and transport the transducer under following ambient conditions:
z Ambient temperature: -20°C ~ 55°C
z Relative humidity: 30% to 95% (no condensation)
z Atmospheric pressure: 700 hPa ~ 1060 hPa
3. When the transducer is sent to MINDRAY Customer Service Department or sales
representative for repair, be sure to disinfect it and keep it in the carrying case to prevent
infection.
4. Sterilize the carrying case as necessary.

12.2 Biopsy Guide

1. The person performing biopsy procedures must
understand diagnostic ultrasound thoroughly and
WARNING: have been trained adequately, otherwise, side effects
may be caused in the patient.
2. In situations listed below, the biopsy needle may fail
to penetrate the target. The incorrect biopsy may
cause various side effects in the patient.
z Use a needle-guided bracket that doesn't match
with the transducer.
z Mounts the needle-guided bracket incorrectly.
z Use a biopsy needle that is unsuitable for the
type of biopsy being performed.
z Use a biopsy needle that is unsuitable for the
type of biopsy being performed.
3. Before and after a biopsy procedure is performed,
confirm that the needle-guided bracket is normal.
Manually confirm that the parts of the needle-guided
bracket do not slip off or move from their proper
positions. If the needle-guided bracket is used when
parts are not securely and correctly installed, the
patient may be injured. If an abnormality is found on
the needle-guided bracket, immediately stop using it
and contact MINDRAY Customer Service Department
or sales representative.

Probes and Biopsy 12-11

 4. Do not use a needle-guided bracket when scanning
is performed. The needle may advance in an
incorrect direction and possibly injure the patient.
Never perform a biopsy during image scanning.
5. Do not freeze an image while performing biopsy
procedure.
6. During biopsy procedures, the needle may deviate
from the desired course due to the tissue
characteristics or the type of needle. In particular,
needles of small diameters may deviate to a greater
degree.
7. Sterilize the transducer and the needle-guided
bracket before and after each ultrasound-guided
biopsy procedure is performed. Fail to do so may
cause the transducer and the needle-guided bracket
become sources of infection.
8. The needle mark displayed on the ultrasound image
does not indicate the actual position of the biopsy
needle. Therefore, it should only be used as a
reference. Always monitor the relative positions of
the biopsy needle during the procedures.
9. Adjust the needle mark before the biopsy procedure
is performed.
10. When performing biopsy procedures, use only sterile
ultrasound gel that is certified to be safe. And
manage the ultrasound gel properly to ensure that it
does not become a source of infection.
11. When performing the operation concerning biopsy,
wear sterile gloves.

12-12 Probes and Biopsy

 12. Image of the biopsy target and the actual position of
the biopsy needle:
Diagnostic ultrasound systems produce tomographic
plane images with information of a certain thickness
in the thickness direction of the transducer. (That is
to say, the information shown in the images consist
all the information scanned in the thickness direction
of the transducer.) So, even though the biopsy
needle appears to have penetrated the target object
in the image, it may not actually have done so. When
the target for biopsy is small, dispersion of the
ultrasound beam may lead to image deviate from the
actual position. Pay attention to this. Image deviation
is shown as the figures below:

Biopsy
Target

The biopsy needle appears to reach the target object in

the image

Probe

Needle
Target
Ultrasound beam

Dispersion of the ultrasound beam

To avoid this problem, note points below:
Do not rely only on the echo of the needle tip on the
image. Pay careful attention to the target object,
which should shift slightly when the biopsy needle
comes into contact with it.
Before you perform the biopsy, please evaluate the
size of the object and confirm if the biopsy can be
carried out successfully.

CAUTION: 1. When using the needle-guided bracket wear sterile gloves to

prevent infection.
2. During biopsy of the probe 65EB10EA, misoperation may
occur when the scan range is not set to “W”, which will affect
the blind area of the image and the accuracy of needle
displaying. The scan range should be kept to “W”.

Probes and Biopsy 12-13

12.2.1 Basic Procedures for Biopsy Guiding
1. Select the right needle-guided bracket and needle, install them properly.
Before biopsy guiding, you can preset bracket model, biopsy display and guide line dot
type. For details, please refer to “12.2.3 Biopsy Preset”.
2. Verify the biopsy guide line. For details, please refer to “12.2.5 Biopsy Menu”.
3. Press <Biopsy> on the control panel.
z If the current probe has no matched bracket; or, the image is frozen and the guide
line is hidden before image frozen, then you can’t enter Biopsy menu.
z Before entering Biopsy menu, the system will prompt you “Please verify guidelines
before biopsy”.
4. Set [Display] as “On” to display the guide line, select the bracket and guide line according
to actual situation. For details, please refer to “12.2.5 Biopsy Menu”.
5. On the Biopsy menu, click [Verify] to enter the Verify menu to verify the guide line. After
the verification, click [Save] on the menu to save the parameter setting. And then click
[Exit] to return to Biopsy menu.
Note:
z If you switch the probe or needle-guided bracket during the biopsy, please verify the
guide line again.
z When exit the Biopsy Verify menu without saving the setting, system will confirm with
you “Data have changed. Do you want to save the changes?”, Click [OK] to save the
setting and return to Biopsy menu. Click [OK] to save the setting and return to biopsy
menu.
6. Scan to locate the target. Center the target in the electronic guidezone path.
7. Direct the needle into the area of interest for specimen.
8. After extraction of the biopsy sample is completed, gently remove the probe from the
body. To exit Biopsy menu: press <Esc>; or, navigate the cursor onto the Other menu.
9. Disassemble the items and properly dispose of these items as required.
Fail to match the guidezone displayed to the guide may cause the
DANGER: needle to track a path outside the zone.
It is extremely important that when using the adjustable angle
biopsy guides, the angle displayed on the screen matches the
angle set on the guide, otherwise the needle will not follow the
displayed guidezone which could result in repeated biopsies or
patient injury.

12.2.2 Needle-guided Brackets

A needle-guided bracket is available for purchase as an optional accessory; it is used in
combination with this transducer. Part of the probes have matched needle-guided bracket and
needles. To order needle-guided brackets, contact MINDRAY Customer Service Department
or sales representative.
For biopsy or treatment, ultrasound-guided biopsy procedures can be performed using this
transducer in combination with a needle-guided bracket (optional accessory) and a biopsy
needle (provided by the user).

Name of Parts
This section describes the parts and corresponding functions of each needle-guided bracket.

12-14 Probes and Biopsy

„ NGB-001
z Metal-needle detachable
Guiding hole
Groove V-shaped guiding block

Lock pin

Needle type adjusting base Needle fixing nut

Needle type dial scale

V-shaped cover
Clamp
Angle block

Angle adjusting base Angle pinch

Angle shift sign Pinch nut

z Metal-needle undetachable
Clamping knob of
the needle guide
Needle guide

Needle guide
hole

Clamp
Locating pit
Needle guide rack
Locating
groove
Grip knob

Needle-guided
bracket

Transducer

Probes and Biopsy 12-15

„ NGB-002
Clamping knob
of the needle guide

Needle guide Needle guide hole

Clamp
Locating pit
Needle guide rack

Grip knob

Locating groove

Needle-guided
bracket

Transducer

„ NGB-004
Locking nut

Needle guide
Retaining clamp
Locating bulge

Transducer
Locating groove

12-16 Probes and Biopsy

„ NGB-005
Clamping knob
of the needle guide
Needle guide rack
Needle guide

Clamp
Locating pit

Needle guide hole

Grip knob
Locating
groove

Needle-guided
bracket

Transducer

„ NGB-007
z Metal:

<8>
<7>
<6>

<10>

<9>

<3>
<4>

<1> <5>

<2>

Probes and Biopsy 12-17

 No. Name Description
Support of needle-guided Used for installing the needle-guided bracket on
<1>
bracket the transducer
Groove and tab of the Respectively matched with the tab and groove of
<2>
needle-guided bracket the transducer
There are 3 types of angles available to be
<3> Angle adjusting base
adjusted
<4> Angle shift sign(40°,50°,60°) Matched with the biopsy angle(40°,50°,60°)
<5> Angle pinch nut Used for fixing the angle lock at a chosen angle
Used for determining the angle of the biopsy;
<6> Angle block
different specifications of blocks can be used
Used for installing biopsy needle; there are five
<7> Guiding block specifications of guiding blocks for different
biopsy needles
Specification of guiding Matched with the corresponding biopsy
<8>
block(14G) needle(14G)
<9> Needle guide hole Used for installing the biopsy needle
Pinch nut of needle-guided Used for locking the
<10>
bracket needle-guided bracket and the transducer

z Plastic

No Name Description
Support of needle- Used for installing the needle-guided bracket on the
<1>
guided bracket transducer
Used for determining the angle of the biopsy; there are
<2> Angle block
three specifications of blocks of angle
Used for installing biopsy needle; there are five
<3> Guiding block specifications of guiding blocks for different biopsy
needles
Groove and tab of the
Respectively matched with the tab and groove of the
<4> needle-guided
transducer
bracket

12-18 Probes and Biopsy

 No Name Description
Specification of
<5> Matched with the corresponding biopsy needle（13G）
guiding block（13G）
<6> Needle guide hole Used for installing the biopsy needle
Specification of angle
<7> Corresponding to the size of the biopsy angle（60°）
block（60°）
„ NGB-016

No Name Description
Clamp of needle-guided Used for installing the needle-guided bracket on the
<1>
bracket transducer.
Groove of the needle-
<2> Matches with the tab of the transducer.
guided bracket
<3> Angle adjusting base There are 3 types of angles available to be adjusted.
Angle shift sign (30°, 40°, Matches with the biopsy angle
<4>
50°) (30°, 40°, 50°).
<5> Angle pinch nut Used for fixing the angle lock at a chosen angle.
Determines the angle of the biopsy; different
<6> Angle block
specifications of blocks can be used.
Used for installing the needles of different specifications,
<7> Guiding block
5 types of needles are available.
Specification of guiding
<8> Matched with the corresponding biopsy needle (14G).
block (14G)
Guiding hole of biopsy
<9> Used for installing the needles.
needle
Pinch nut of needle- Used for locking the needle-guided bracket and the
<10>
guided bracket transducer.

12.2.3 Biopsy Preset

Open Biopsy page via [Setup]-> [System Preset]-> [Biopsy].
„ Bracket model
To set the default bracket for a probe.
(1) Select a probe model in the Probe Model list, all the supported bracket models will be
displayed in the “Bracket Model” list on the right side. (If the selected probe has no
bracket matched, no model is displayed.)

Probes and Biopsy 12-19

 (2) Click to select a bracket model on the Bracket Model list.
(3) Click [OK] to confirm the setting and return to Setup menu.
„ Parameter
To set if to display/hide guide line.
(1) Check [Guide Line Display] to set the guide line display, otherwise, the guide line is
hidden when enters biopsy status.
(2) Click [OK] to confirm the setting and return to Setup menu.

12.2.4 Needle-guided Bracket Inspection and Installation

Inspection of the Needle-guided Bracket
Be sure to perform inspections before and after use of the needle-guided bracket. If an
abnormality is found on the needle-guided bracket, immediately stop using it and contact
MINDRAY Customer Service Department or sales representative.
1. Sterilize the needle-guided bracket before and after use.
2. Confirm that the needle-guided bracket is free of damage, deformation, stripping,
malfunction, loose or missing parts.
3. Confirm that the needle-guided bracket is securely mounted in the correct position.

Installing the Needle-guided Bracket

„ NGB-001
z Metal-needle detachable
1. Put on the sterile transducer sheath.
2. Hold the transducer by one hand, select the proper needle-guided bracket, and hold
it with the other hand. Match the groove of the bracket with the tab of the transducer.
Amount the bracket onto the transducer.

3. Screw the pinch nut of the needle-guided bracket to confirm that the needle-guided
bracket is properly installed on the transducer.
4. Adjust the dial scale to the required needle type shift, and then screw the needle
fixing nut to lock the dial scale.(To adjust the dial scale you have to loose the needle
fixing nut first.)
5. Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the
needle type adjusting base, so as to install the needle into the guiding hole.

z Metal-needle undetachable
1. Put on the sterile transducer sheath.

12-20 Probes and Biopsy

 2. Inosculate the locating groove on the clamp with the two raised edges on the
transducer head and aligning the locating pit of the clamp to the convex point on the
transducer head.
3. Turn the grip knob at the tail of the needle-guided bracket tightly.

„ NGB-002
1. Put on the sterile transducer sheath.
2. Inosculate the locating groove on the clamp with the two raised edges on the transducer
head and aligning the locating pit of the clamp to the convex point on the transducer head.
3. Turn the grip knob at the tail of the needle-guided bracket tightly.

„ NGB-004
1. Put on the sterile transducer sheath.

2. Open the retaining clamp, align the needle-guided bracket with the transducer to locate
the locating bulge on the needle guide to the locating grooves on the transducer, and
then turn the retaining clamp to match it with the transducer.

3. When the retaining clamp is turned to the right position, the locking nut will lock the
retaining clamp and the needle-guided bracket is then mounted to the right position.

„ NBG-005
1. Put on the sterile transducer sheath.
2. Inosculate the locating groove on the clamp with the two raised edges on the transducer
head and aligning the locating pit of the clamp to the convex point on the transducer head.
3. Turn the grip knob at the tail of the needle-guided bracket tightly.

„ NGB-007
z Metal
1) Put on the sterile transducer sheath.

Probes and Biopsy 12-21

 2) Hold the transducer by one hand, select the proper needle-guided bracket, and
hold it with the other hand. Match the groove and tab with the tab and groove of
the transducer respectively. Amount the bracket onto the transducer.

3) Screw the pinch nut of the needle-guided bracket to confirm that the needle-
guided bracket is properly installed on the transducer.
4) Select a proper guiding block and push it into the groove above the angle block,
and clamp it tightly.

5) Screw the nut of the block to secure the block.

6) Insert a biopsy needle with the same specification as that of the guiding block
into the hole of the guiding block.

z Plastic
1) Put on the sterile transducer sheath.
2) Hold the transducer by one hand, select proper needle-guided bracket, and hold
it with the other hand. Align the narrow end tab of the needle-guided bracket with
the groove of the transducer, then push the needle-guided bracket forward,
making the tabs and the grooves of the needle-guided bracket to match with the
grooves and tabs of the transducer.

3) Check manually to confirm that the needle-guided bracket is securely installed

on the transducer.

12-22 Probes and Biopsy

 4) Select a proper guiding block and push it into the groove above the angle block,
and clamp it tightly.

5) Insert a biopsy needle with the same specification as that of the guiding block
into the hole of the guiding block.

„ NGB-016
1. Put on the sterile transducer sheath.
2. Select a proper needle-guided bracket, and match the groove with the tab of the
transducer. Mount the bracket onto the transducer.

3. Screw the pinch nut of the needle-guided bracket to confirm that the needle-guided
bracket is properly installed on the transducer.
4. Select a proper guiding block and push it into the groove above the angle block, and
clamp it tightly.

5. Screw the nut of the block to secure the block.

6. Insert a biopsy needle with the same specification as that of the guiding block into the
hole of the guiding block.

Probes and Biopsy 12-23

 Ensure that all guide parts are seated properly prior to performing
CAUTION: a biopsy.

12.2.5 Biopsy Menu

Press <Biopsy> to show the biopsy menu.

„ Select biopsy bracket angle

If the needle-guided bracket supports more than one biopsy angle, you can select the
angle from the drop-down list.
„ Select Dot size
Move the cursor onto [Dot Size], press <Set> to select the dot size among Small, Medium
and Big.
Tips:
z The guide line is a dot line which consists of two kinds of dots, the distance between
two dots is depth dependent. Move the cursor onto the big dot, a numeral, which
represents the biopsy depth, is displayed.
z The biopsy guidezone adjusts along with image adjustments, such as image
inversion/rotations, zoom and depth changes.
z When the imaging depth and area are changed, the guide line will be adjusted.

„ Display or hide the guide line

Set [Biopsy Kit] on the menu to “Off” to hide the guide line.
Or, press <Biopsy> on the control panel to display or hide the guide line.
„ In B mode image menu, you can also display, hide or select the needle-guide bracket via
[Biopsy Kit] item.

12.2.6 Verify Biopsy Guide Line

Prior to each biopsy procedure, be sure to verify the guide
WARNING: 1.
line.
If the needle is not consistent with the guide line, DO NOT
2.
perform the biopsy procedure.

12-24 Probes and Biopsy

NOTE: 1. You can perform guide line verification on a single live B image only, and all
biopsy-irrelevant operations are forbidden.

2. For bi-planar probe applied biopsy, the verification is performed on the first
guide line, the other guide lines can move together with the first one in
parallel.

1. Confirm that the needle-guided bracket has been installed securely in the correct position.
2. Prepare a container filled with sterile water.
3. Place the head of the transducer in the sterile water, and get a biopsy needle into the
needle guide.
4. When the biopsy needle appears on the image, please adjust the parameters of the
menu on the screen to make the biopsy needle is displayed at almost the same position
as the selected needle mark.

z Adjust guide line position

Move the cursor onto [Position], press <Set> key to move it linearly, or press and
rotate the multifunctional-knob. This is operative when there is only one guide line
displayed.
z Adjust angle
Move the cursor onto [Angle], press <Set> key to change the guide line angle, or
press and rotate the multifunctional-knob. This is operative when there is only one
guide line displayed.
z Save verified settings
After the position and angle of the guide line are adjusted, click [Save], and the
system will save the current settings of the guide line. When enter biopsy again, the
displayed Position and Angle are the verified value.
z Restore the factory default settings
Click [Load Factory], and the position and angle of the guide line will be restored to
the factory default settings.
z Exit the biopsy verify status
Click [Exit], and the system will exit the verification status of the guide line.

12.2.7 Removing the Needle-guided Bracket

„ NGB-001
z Metal-needle detachable
1. Pull the lock pin and open up the V-shaped cover to expose the needle.

Probes and Biopsy 12-25

 2. Separate the bracket and the transducer from the needle.
3. Screw the pinch nut to release the needle-guided bracket.

4. Separate the bracket and the transducer.

z Metal-needle undetachable
While holding the transducer and the needle-guided bracket, open the Grip knob of the
needle-guided bracket.
„ NGB-002
While holding the transducer and the needle-guided bracket, open the Grip knob of the
needle-guided bracket.

„ NGB-004
Hold the transducer in the left hand, unscrew the locking nut with the right hand to open
the retaining clamp, and then raise the needle-guided bracket to separate the locating
bulge from the locating grooves.

„ NGB-005
While holding the transducer and the needle-guided bracket, open the Grip knob of the
needle-guided bracket.

„ NGB-007
z Metal
1) Screw the nut of the guiding block and remove the guiding block slightly along
the direction of the needle’s tail.

2) Separate the residual part of the needle-guide bracket and the transducer from
the needle.
3) Screw the pinch nut of the bracket, and remove the needle-guided bracket from
the transducer.

12-26 Probes and Biopsy

 z Plastic
1) Remove the guiding block slightly along the direction of the needle’s tail.
2) Separate the residual part of the needle-guide bracket and the transducer from
the needle.

3) Remove the support of needle-guided bracket from the transducer.

„ NGB-016
1. Screw the nut of the guiding block and remove the guiding block slightly along the
direction of the needle’s tail.

2. Separate the residual part of the needle-guide bracket and the transducer from the
needle.
3. Screw the pinch nut of the bracket, and remove the needle-guided bracket from the
transducer.

4. Separate the transducer and the needle-guided bracket.

Probes and Biopsy 12-27

12.2.8 Clean and Sterilize the Needle-guided Bracket
Cleaning
1. Wear sterile gloves to prevent infection.
2. Or, wash with clean water or soapy water to remove all the foreign matters, or, wipe the
bracket with a soft ethyl carbamate sponge.
3. Wipe off the water on the needle-guided bracket using sterile cloth or gauze after washing
it.
Please follow the instructions in the manual for cleaning.

Sterilization
1. Wear sterile gloves to prevent infection.
2. Clean the needle-guided bracket before sterilizing it. MINDRAY recommends the
following solution or sterilizing system to sterilize the needle-guided bracket.
3. Follow local regulations when selecting and using the disinfectant.
„ Glutaraldehyde-based sterilant:
Chemical
Trade name Procedures
name
Cidex Please refer to the instructions provided by the
Glutaraldehyde Activated manufacturer of the solution for details.
(2.4%) Dialdehyde Soak the transducer into the activated solution for 10
Solution hours (20-25℃)

Before safety and performance is affected, plastic bracket NGB-007 can be sterilized by
Cidex Activated Glutaraldehyde Solution for at least 233 times (10 hours for one time).
z Refer to the instructions provided by the chemical manufacturer concerning
concentration of the solution, and method of disinfections and dilution. Note that the
glutaraldehyde disinfectant solution needs an activating solution.
z Rinse the needle-guided bracket thoroughly with sterile water to remove all chemical
residues on it.
z Wipe off the water on the needle-guided bracket with sterile cloth or gauze after
rinsing it.
„ STERRAD 100S low-temperature hydrogen peroxide gas plasma sterilization system
Chemical name Trade name Procedures
Hydrogen
Hydrogen Please refer to the instructions provided by the
peroxide gas
peroxide vapor producer of the solution for details.
plasma
z Refer to the instruction of STERRAD 100S sterilizing system provided by the
manufacturer for operation instructions and cautions.
z The STERRAD 100S low-temperature hydrogen peroxide gas plasma sterilization
system is available for metal needle-guided brackets.

„ High-pressure steam sterilization (only applicable for metal guided-bracket)

Autoclaving (moist heat) 121° C for 20 minutes.

NOTE: The high-pressure steam/ immersion sterilization do not affect the bracket duration
life, and the duration life is affected by the daily application of the bracket. Please
check the appearance of the bracket before using.

12-28 Probes and Biopsy

12.2.9 Storage and Transportation
■ Don’t use the carrying case for storing the needle-guided bracket. If the carrying case is
used for storage, it may become a source of infection.
■ Between examinations, keep the needle-guided bracket in a sterile environment.
■ When the needle-guided bracket is sent to your MINDRAY representative for repair, be
sure to disinfect or sterilize it and keep it in the carrying case to prevent infection.
■ Sterilize the carrying case as necessary.
■ Store or transport the needle-guided bracket under the following ambient conditions:
z Ambient temperature: -20°C ~ 55°C
z Relative humidity: 30% to 95% (no condensation)

12.2.10 Disposal
Be sure to dispose the needle-guided bracket only after sterilizing it.
Contact your MINDRAY representative when disposing of this device.

Probes and Biopsy 12-29

13 Battery
1. DO NOT install or detach the battery ad arbitrium
WARNING: The batteries have protective mechanism and circuit.
DO NOT disassemble or alter the battery.
2. DO NOT short-circuit the batteries by directly
connecting the negative terminals with metal objects.
3. DO NOT heat the battery or discard it in a fire.
4. Keep the batteries away from fire and other heat
sources.
5. DO NOT immerse the batteries in water or allow them
to get wet.
6. DO NOT charge the batteries near a heat source or in
direct sunlight.
7. DO NOT pierce the batteries with a sharp object, hit or
step on them.
8. DO NOT use the batteries mixed with other battery
models.
9. DO NOT put the batteries into a microwave oven or
pressurized container.
10. If the batteries emit an odor or heat, are deformed or
discolored, or in a way appear abnormal during use,
charging or storage, immediately remove them and
stop using them.

13.1 Overview
The battery charges when the system is connected to the AC power supply.
z Generally, if the system is turned off, a completely discharged battery will fully charge
in less than 3 hours; or generally a battery has been charged for 2 hours, it can
restore the quality of electric charge to above 95%.
NOTE: 1. It is recommended to charge the batteries when the system is turned off, thus
you can quickly charge the battery and save time.
2. Power off the system if you will not use the system for a long period of time
(including storage/ transportation condition), and you should not allow the
system in standby status, otherwise the batteries will be out of power and
permanently damaged.
When the external power supply is not connected, a lithium-ion battery will provide the power.
The model of the chargeable lithium-ion battery (hereinafter called battery for short) is
LI34I002A.

Battery 13-1
NOTE: 1. Only use the specified batteries.
2. If there is only one battery in the system, it cannot supply power and
cannot be charged.

13.2 Precautions
1. Before using the battery, carefully read the description in the label on the surface of the
battery.
2. When you use the battery at the first time and find that it is dirty or emit an odor, do not
use it.
3. Do not expose the battery to heat sources or high pressure.
4. Do not leave the battery in direct sunlight.
5. Store the battery out of the reach of children. Store the battery out of the reach of children.
6. The battery is designed to be charged only in this system; charge the battery only when
the ambient temperature is between 0 and 40 ℃.
7. When the battery is out of power, please charge it immediately.
8. For storage longer than three months, charge a battery to a level no more than 45%.
9. Do not knock the battery.

13.3 Installing and Removing the Batteries

Turn off the system and disconnect the adapter from the
WARNING: main unit before installing or removing batteries. DO NOT
install or remove batteries when the system is turned on or
the system is turned off but the adapter is connected with
the system.
The battery is put in the battery bays at the back side of the system. You can install or remove
it when the system is turned off and the power cord is disconnected from the main unit.
To install the battery:
1. Turn off the unit and detach the power cord from the main unit.
2. You can see a battery bay at the back of the system. (Note that the battery shall be put in
correct direction). Put the battery into the bay and push to the right side until it’s tightly
locked.
3. Close the battery cover.

13-2 Battery
 Battery cover

To remove the battery:

1. Turn off the unit and detach the power cord from the main unit.
2. Open the battery cover.
3. Push the battery to left until it’s released.
4. Take out the battery from the bay.

13.4 Battery Status Indicator

The battery status indicator is located in the lower right corner of the screen, indicating the
battery capacity.

: indicates the battery capacity is empty.

: indicates the battery capacity is full.

When the power capacity is not enough, the system will pop up a prompt:
Warning! Battery is out of power! Please connect to power supply or system will be shut down
in one minute. Connect the power supply to afford normal work.

13.5 Checking Battery Performance

The battery performance may be degraded over time, so you need to check the battery
performance periodically. The checking procedures are shown as follows:
1. Stop the ultrasound exam.
2. Connect the system to the AC power supply to charge the batteries until current capacity
is full.
3. Disconnect the system from the AC power supply to power the system by the batteries
until the system automatically shuts down.
4. The powering time of the batteries indicates the battery performance.
If the powering time of the battery is much shorter than that specified in the Specification
Manual, you may replace the battery or contact the service personnel.

Battery 13-3
13.6 Battery Disposal
NOTE: You should observe the local regulations when disposing of the battery.

13-4 Battery
14 Acoustic Output
This section of the operator’s manual applies to the overall system including the main unit,
probes, accessories and peripherals. This section contains important safety information for
operators of the device, pertaining to acoustic output and how to control patient exposure
through use of the ALARA (as low as reasonably achievable) principle. Also this section
contains information regarding the acoustic output testing and the real-time output display.
Read this information carefully before using the system.

14.1 Concerns with Bioeffects

Diagnostic ultrasound is recognized as being safe. In fact, there have been no reports of
injuries to patients caused by diagnostic ultrasound.
It cannot be stated categorically that ultrasound is 100% safe. Studies have revealed that
ultrasound with extremely high intensity is harmful to body tissues.
Diagnostic ultrasound technology has made a great leap forward during the last several years.
This rapid advance has generated concerns about the potential risk of bioeffects when new
applications or diagnostic technologies become available.

14.2 Prudent Use Statement

Although there are no confirmed biological effects on patients caused by exposures from
present diagnostic ultrasound instruments, the possibility exists that such biological effects
may be identified in the future. Thus ultrasound should be used in a prudent manner to
provide medical benefit to the patient. High exposure levels and long exposure times should
be avoided while acquiring necessary clinical information.

14.3 ALARA Principle (As Low As

Reasonably Achievable)
It is required to practice ALARA when using ultrasound energy. Practicing ALARA ensures that
the total energy level is controlled below a low enough level at which bioeffects are not
generated while diagnostic information is being accumulated. The total energy is controlled by
output intensity and total radiation time. The output intensity necessary for examinations
differs depending on the patient and the clinical case.
Not all examinations can be performed with an extremely low level of acoustic energy.
Controlling the acoustic level at an extremely low level leads to low-quality images or
insufficient Doppler signals, adversely affecting the reliability of the diagnosis. However,
increasing the acoustic power more than necessary does not always contribute to an increase
in quality of information required for diagnosis, rather increasing the risk of generating
bioeffects.
Users must take responsibility for the safety of patients and utilize ultrasound deliberately.
Deliberate use of ultrasound means that output power of ultrasound must be selected based
on ALARA.
Additional information regarding the concept of ALARA and the possible bioeffects of Ultrasound is
available in a document from the AIUM (American Institute of Ultrasound Medicine) title “Medical
Ultrasound Safety”.

Acoustic Output 14-1

14.4 MI/TI Explanation
14.4.1 Basic Knowledge of MI and TI
The relationship of various ultrasound output parameters (frequency, acoustic pressure and
intensity, etc) to bioeffects is not fully understood presently. It is recognized that two
fundamental mechanisms may induce bioeffects. One is a thermal bioeffect with tissue
absorption of ultrasound, and another one is a mechanical bioeffect based on cavitations.
Thermal Index (TI) gives the relative index of temperature increase by thermal bioeffect, and
Mechanical Index (MI) gives the relative index of mechanical bioeffect. TI and MI indices
reflect instantaneous output conditions, so they DO NOT consider the cumulative effects of
the total examination time.
„ MI (Mechanical Index):
The mechanical bioeffects are the result of compression and decompression of insonated
tissues with the formation of micro bubbles that may be referred to as cavitations.
MI is an index that shows the possibility of the cavitations generation based on acoustic
pressure, and the value in which the peak-rarefactional acoustic pressure is divided by the
square root of the frequency. Therefore MI value becomes smaller when the frequency is
higher or the peak-rarefactional acoustic pressure is lower, it becomes difficult to generate the
cavitations.
MI = Pr, α

fawf × CMI

Wherein, CMI = 1 (MPa / MHz )

For the frequency 1 MHz and the peak-rarefactional acoustic pressure 1 MPa, MI becomes 1.
It is possible to think MI to be one threshold of the cavitations generation. Especially, it is
important to keep MI value to be low when both gases and the soft tissues exist together, for
such as lung exposure in cardiac scanning and bowel gas in abdominal scanning.
„ TI (Thermal Index):
TI is determined by the ratio of the total acoustic power to the acoustic power required to
raise the tissue temperature by 1 degree C. In addition, because the temperature rises is
greatly different according to tissue structures, TI is divided three kinds: TIS (Soft-tissue
Thermal Index), TIB (Bone Thermal Index) and TIC (Cranial-bone Thermal Index).
z TIS: Thermal index related to soft tissues, such as abdominal and cardiac
applications.
z TIB: Thermal index for applications, such as fetal (second and third trimester) or
neonatal cephalic (through the fontanel), in which the ultrasound beam passes
through soft tissue and a focal region is in the immediate vicinity of bone.
z TIC: Thermal index for applications, such as pediatric and adult cranial applications,
in which the ultrasound beam passes through bone near the beam entrance into the
body.
WFUMB (World Federation for Ultrasound in Medicine and Biology) guidelines: state that
temperature increase of 4 degree C for 5 min or more should be considered as
potentially hazardous to embryonic and fetal tissue.
The smaller the MI/TI values, the lower the bioeffects.

14.4.2 MI/TI Display

TI and MI values are displayed in the upper part of the screen in real-time. The operator
should monitor these index values during examinations and ensure that exposure time and
output values are maintained at the minimum amounts needed for effective diagnosis.

14-2 Acoustic Output

NOTE: If there is a value of MI or TI exceeds 1.0, you must be careful to practice the
ALARA principle.
The display precision is 0.1

14.5 Acoustic Power Setting

„ Acoustic power adjustment
Click [A. power] in the menu to adjust the acoustic power percentage, and the value is
displayed on the screen. The greater the acoustic power percentage, the greater the current
acoustic output.
When the image is frozen, the system stops transmitting acoustic power.
„ Default setting of acoustic power
Selection of diagnostic applications is the most important factor for controlling ultrasound
output.
The permissible level of intensity of ultrasound differs depending on the region of interest. For
fetal examinations, in particular, much care must be exercised.
In this system, imaging setups can be created using the ultrasound output set by you. At this
time, the default function is disabled. It is the user’s responsibility for any change to the
default settings.
Default choices

Initial power 7% to 100%*

* Definition of 100%:
The maximum acoustic power of a transducer determined by the increase in transducer
surface temperature in the selected mode and the acoustic power restrictions specified
by the FDA.
NOTE: This system automatically returns to the settings whenever changes are made to
the values (when you turn on the power, switch between probes, press [End Exam],
or select Return in the Setup menu). In the factory default settings, the Acoustic
Output is limited below settings. Following the ALARA restriction, you are allowed to
increase the acoustic power under FDA 510(k) Guidance-Track3 limits and to set it
in the image preset screen.
The acoustic output of the system has been measured and calculated in accordance with
IEC60601-2-37: 2005, FDA 510(K) GUIDANCE, Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment (NEMA UD-2 2004) and the “Standard for Real-Time
Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment (AIUM and
NEMA UD-3 2004).

14.6 Acoustic Power Control

The qualified operator may use the system controls to limit the ultrasound output and to adjust
the quality of the images. There are three categories of system controls relative to output.
They are controls that have direct effect on the output, controls that indirectly control output
and controls that are receiver controls.
„ Direct Controls
It is possible to control, if necessary, the acoustic output with the menu control. In this case,
the maximum value of the acoustic output never exceeds an MI of 1.9, TI of 6 and an ISPTA.3 of
720 mW/cm2 in any mode of operation.

Acoustic Output 14-3

„ Indirect Controls
The controls that indirectly affect output are many imaging parameters. These are operating
modes, frequency, focal point positions, image depth and pulse repetition frequency (PRF).
The operating mode determines whether the ultrasound beam is scanning or non-scanning.
Thermal bioeffect is closely connected to M mode.
Acoustic attenuation of tissue is directly related to transducer frequency.
The focal point is related to active aperture of transducer and beam width.
For the higher PRF (pulse repetition frequency), the more output pulses occur over a period
of time.
„ Receiver Controls
The receiver controls (for example, gain, dynamic range, and image post-processing, etc.) do
not affect output. These controls should be used, when possible, to improve the image quality
before using controls that directly or indirectly affect output.

14.7 Acoustic Output

14.7.1 Derated Ultrasonic Output Parameters
In order to determine the relevant Ultrasonic Output Parameters, a method is used which
allows for the comparison of ultrasound systems which operate at different frequencies and
are focused at different depths. This approach, called "derating" or "attenuating", adjusts the
acoustic output as measured in a water tank to account for the effect of ultrasound
propagation through tissue. By convention, a specific average intensity attenuation value is
used, which corresponds to a loss of 0.3 dB/cm/MHz. That is, the intensity of ultrasound will
be reduced by 0.3 dB/MHz for every centimeter of travel from the transducer. This can be
expressed by the following equation:

I atten = I water ×10(－0.3 / 10 × f c × z )

Where Iatten is the attenuated intensity, Iwater is the intensity measured in a water tank (at
distance z), fc is the center frequency of the ultrasound wave (as measured in water), and z is
the distance from the transducer. The equation for attenuating pressure values is similar
except that the attenuation coefficient is 0.15 dB/cm/MHz, or one-half the intensity coefficient.
The intensity coefficient is double the pressure coefficient because intensity is proportional to
the square of pressure.
Although the attenuation coefficient chosen, 0.3 dB/cm/MHz, is significantly lower than any
specific solid tissue in the body, this value was chosen to account for fetal examinations. In
early trimester ultrasound fetal examinations, there may be a significant fluid path between
the transducer and the fetus, and the attenuation of fluid is very small. Therefore the
attenuation coefficient was lowered to account for this case.

14.7.2 Limits of Acoustic Output

In accordance with the FDA Track 3 requirements, the derating (or attenuated) approach was
incorporated into the FDA Acoustic Output Limits, as listed below. The maximum acoustic
output level from any transducer in any operating mode is expected to fall below these limits.
FDA Maximum Acoustic Output Limits for Track 3 (Attenuated Values)

Application Ispta.3 (mW/cm2) Isppa.3 (W/cm2) MI

Regions Or
(except eyes) 720 ≤ 190 ≤ 1.9

14-4 Acoustic Output

14.7.3 Differences between Actual and Displayed MI and
TI
In operation, the system will display to the operator the Acoustic Output Parameters Thermal
Index, TI, or Mechanical Index, MI (or sometimes both parameters simultaneously). These
parameters were developed as general indicators of risk from either thermal or mechanical
action of the ultrasound wave. They serve to indicate to the operator whether a particular
setting of the system increases or decreases the possibility of Thermal or Mechanical effect.
More specifically, they were designed to assist in the implementation of the ALARA principle.
As an operator changes a given system control, the potential effect of the change in output
will be indicated. However, the Thermal Index is not the same as temperature rise in the body,
for several reasons. First of all, in order to provide a single display index to you, a number of
simplifying assumptions had to be made. The biggest assumption was the use of the
attenuating formula described above, which is much lower than the actual value for most
tissues within the body. Scanning through muscle or organ tissue, for example, will produce
much higher attenuation than 0.3 dB/cm/MHz. There were also significant simplifications
made for the thermal properties of tissue. Therefore, scanning through highly perfused tissue,
such as the heart or vasculature, will produce significantly less thermal effect than that
suggested by the Thermal Index.
Similarly, the Mechanical Index was derived to indicate the relative possibility of mechanical
(cavitation) effects. The MI is based on the derated peak-rarefactional pressure and the center
frequency of the ultrasound wave. The actual peak-rarefactional pressure is affected by the
actual attenuation caused by tissue in the path between the transducer and the focal point.
Again, all solid tissues within the body have higher attenuation than the proscribed 0.3
dB/cm/MHz value, and therefore, the actual peak-rarefactional pressure will be lower. Further,
the actual peak-rarefactional pressure will change depending upon the region of the body
being scanned.
For these reasons, the TI and MI displays should only be used to assist the operator in
implementing ALARA at the time of the patient examination.

Acoustic Output 14-5

14.8 Measurement Uncertainty
Ispta 28.5%
Isppa 28.5%
Center frequency (fc) 2%
Total power (W) 28.5%
(5.1% for Scan-mode and Combined-mode)
Peak-rarefactional pressure 14.7%

14.9 References for Acoustic Power and

Safety
1. “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993
2. “Medical Ultrasound Safety” issued by AIUM in 1994
3. "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision
3" issued by AIUM/NEMA in 2004
4. "Standard for real-time display of thermal and mechanical acoustic output indices on
diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in 2004
5. "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers" issued by FDA in 2008.
6. “Medical electrical equipment – Part 2-37: Particular requirements for the safety of
ultrasonic medical diagnostic and monitoring equipment” issued by IEC in 2005.

14-6 Acoustic Output

15 Guidance and
Manufacturer’s Declaration
The system complies with the EMC standard IEC60601-1-2: 2007.
The use of unapproved accessories may diminish system
WARNING: performance.

NOTE: 1 Use of accessories, probes, and cables other than those specified may result in
increased emission or decreased immunity of system.
2 The system or its components should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the system or its
components should be observed to verify normal operation in the configuration in
which it will be used.
3 The system needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided below.
4 Other devices may interfere with this system even though they meet the
requirements of CISPR.
5 Preventing conducted RF immunity. Due to technological limitations, the
conducted RF immunity level are limited to 1Vrms level, conducted RF
interference above 1Vrms may cause wrong diagnosis and measurements. We
suggest that you position system further from sources of conducted RF noise.
6 Operation of system, in the case that the patient physiological signal is lower
than the minimum amplitude or value specified in the product specifications, may
cause inaccurate results.
7 Portable and mobile RF communications equipment can affects system. See
tables 1, 2, 3, and 4 below.

Guidance and Manufacturer’s Declaration 15-1

TABLE 1
GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC EMISSIONS
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
ELECTROMAGNETIC ENVIROMENT－
EMISSIONS TEST COMPLIANCE
GUIDANCE
The system uses RF energy only for its
internal function. Therefore, its RF
RF emissions emissions are very low and are not likely
Group 1
CISPR 11
to cause any interference in nearby
electronic equipment.
RF emissions
Class B
CISPR 11 The system is suitable for use in all
establishments including domestic
Harmonic Emissions
Class A establishments and those directly
IEC 61000-3-2 connected to the public low-voltage
Voltage Fluctuations/ Flicker power supply network that supplies
Emissions Compliance buildings used for domestic purposes
IEC 61000-3-3

15-2 Guidance and Manufacturer’s Declaration

TABLE 2
GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
IEC 60601 COMPLIANCE ELECTROMAGNETIC
IMMUNITY TEST
TEST LEVEL LEVEL ENVIRONMENT-GUIDANCE
Electrostatic ±6 kV contact; ±6 kV contact; Floors should be wood,
Discharge(ESD) ±8 kV air ±8 kV air concrete or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the
relative humidity should be at
least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should
Transient / burst supply lines; supply lines; be that of a typical
IEC 61000-4-4 ±1 kV for ±1 kV for commercial or hospital
input/output input/output lines environment.
lines
Surge ±1 kV line(s) to ±1 kV line(s) to Mains power quality should
IEC 61000-4-5 line(s); line(s); be that of a typical
±2 kV line(s) to ±2 kV line(s) to commercial or hospital
earth earth environment.

Voltage dips, <5% UT (>95% <5% UT (>95% Mains power quality should
Short interruptions dip in UT ) for dip in UT ) for 0.5 be that of a typical
and voltage 0.5 cycle cycle commercial or hospital
variation on power environment. If you require
supply input continued operation during
voltage 40% UT (60% 40% UT (60% dip power mains interruptions, it
dip in UT ) for 5 in UT ) for 5 cycle is recommended that our
IEC 61000-4-11 cycle product be powered from an
70% UT (30% dip uninterruptible power supply
70% UT (30% in UT ) for 25 or a battery.
dip in UT ) for 25 cycle
cycle
<5% UT (>95%
<5% UT (>95% dip in UT ) for 5
dip in UT ) for 5 sec
sec
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 HZ) fields should be at levels
magnetic field characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.
NOTE: UT is the A.C. mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration 15-3

TABLE 3
GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
IMMUNITY IEC 60601 COMPLIANCE ELECTROMAGNETIC
TEST TEST LEVEL LEVEL ENVIRONMENT-GUIDANCE
Portable and mobile RF
communications equipment should
be used no closer to any part of
system, including cables, than the
3 Vrms recommended separation distance
Conduced RF calculated from the equation
150 kHz - 80 1 Vrms
IEC 61000-4-6 applicable to the frequency of the
MHz
transmitter. Recommended
separation distance
d = 3.5 x P
d = 1.2 x P 80 MHz to 800 MHz

d = 2.3 x P 800 MHz to 2.5GHz

Where, P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
3 V/m
Radiated RF Field strengths from fixed RF
80MHz - 3 V/m
IEC 61000-4-3 transmitters, as determined by an
2.5GHz electromagnetic site survey, should
be less than the compliance level in
each frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:

Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
„ Field strengths from fixed transmitters, such as base stations for radio (cellular
/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which system is used exceeds the applicable RF compliance level
above, system should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as
reorienting or relocating system.
„ Over the frequency ranges 150kHz to 80MHz, field strengths should be less than
1V/m.

15-4 Guidance and Manufacturer’s Declaration

TABLE 4
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE
RF COMMUNICATION DEVICE AND SYSTEM
The system is intended for use in an electromagnetic environment in which radiated RF
disturbance are controlled. The customer or the user of system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communication equipment (transmitters) and system as recommended below,
according to the maximum output power of the communication equipment.
Separation Distance According to Frequency of Transmitter
Rated Maximum (m)
Output power of 150kHz -80MHz 80MHz-800MHz 800MHz-2.5GHz
Transmitter
(W) ⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡7 ⎤
d =⎢ ⎥ P d =⎢ ⎥ P d=⎢ ⎥ P
⎣ 1 ⎦ ⎣ 3 ⎦ ⎣3⎦
0.01 0.35 0.12 0.23
0.1 1.11 0.37 0.74
1 3.50 1.17 2.34
10 11.07 3.69 7.38
100 35.00 11.67 23.34
For transmitters at a maximum output power not listed above, the recommended
separation distanced in meters (m) can be determined using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
If system image distortion occurs, it may be necessary to position system further from
sources of conducted RF noise or to install external power source filter to minimize RF
noise to an acceptable level.

Note 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

Guidance and Manufacturer’s Declaration 15-5

16 System Maintenance
Routine system maintenance shall be carried out by the user. Service maintenance will be
provided by Mindray service engineers while the system is under warranty. System
maintenance after the warranty has expired is the full responsibility of the owner / operator.
1. Only an authorized Mindray service engineer can perform
WARNING: maintenance not specified in this operator’s manual.
2. For the sake of the system performance and safety, you
should perform periodical checks for the system.

16.1 Daily Maintenance

You are responsible for daily maintenance.

16.1.1 Cleaning the System

Before cleaning the system, be sure to turn off the power and
WARNING: disconnect the power cord from the outlet. If you clean the
system while the power is “On”, it may result in electric shock.
„ Cleaning the probe
Please refer to the operator’s manual of the corresponding transducer or “12.1.5 Probes
Cleaning and Disinfection”to perform cleaning and disinfection.
„ Cleaning the probe cable
a) Use soft dry cloth to wipe off stains from the probe cable.
b) If it is difficult to clean the stains thoroughly, use soft cloth dipped with mild
detergent, and then let the cable air dry.
„ Cleaning the monitor
Using a soft cloth, apply a glass cleaner directly to the cloth and wipe down the monitor to
remove finger marks, dust and smudges. Allow the monitor to air-dry.
NOTE: 1. Do not use hydrocarbon glass cleaner or cleaner for OA (Office Automation)
equipment to clean the monitor. These substances may cause deterioration of
the monitor.
2. Keyboard on the control panel should be cleaned periodically, otherwise, keys
maybe blocked by dirt and buzzer dings, keys don’t work.
„ Cleaning the control panel, cover and bracket
Use dry soft cloth to clean the surface of the system. If the system is dirty, moisten the
soft cloth with a mild or neutral detergent and wipe off any stains. Use dry soft cloth to
remove any moisture and allow all hard surfaces to completely air-dry.
„ Cleaning the trackball
z Tool: tissue paper or dry cotton cloth
z Method:
The trackball on the control panel is used to move the cursor and plays an importance part in
man-machine communication. As one of the most frequently used parts on the control
panel ,it may become ineffective due to dirt that enters into the trackball module.

System Maintenance 16-1

 a) Disassembling the trackball:
Rotate the trackball clamp ring 35 degrees anticlockwise. When the clamping ring lifts,
remove the clamping ring and trackball. You can draw out the ball with the help of adhesive
tape. See the figures below.

Clamp ring

Track ball

Rotate clamp ring 35 degrees anticlockwise Remove clamp ring Draw out the ball
b) Cleaning
Clean the lens slightly using the tissue until there is no foreign matter. Then clean the other
parts and the dust excluder. Make sure to exert force properly when clean the small ball,
otherwise, the small ball may drop down. See the figure below. No system shutdown is
required during the whole clean. Reinstall the ball and clamp ring after the clean is finished.

Lens
Small ball (x3)

Waterspout

When liquid is spray onto the trackball area, most of the liquid can be discharged through the
waterspout, besides, you can dry the leaving water using the tissue or cloth.
c) Installing the trackball
Put back the ball, align the buckle with gap of the front cover, press the clamp ring with both
hands and rotate it 35 degrees clockwise to click the buckle. At this moment, the clamp ring
cannot be moved any further, it indicates that the clamp ring clicks in position. See the figure
below. See figure below.

Before installing Turn 35 degrees lockwise Installed

Buckle (x2)

16-2 System Maintenance

16.1.2 Checking Transducer
Check the transducer connector for crack every time before use. DO NOT use the transducer
if a crack is inspected. A thoroughly inspection to the transducer including cable and
connector is required every time when you clean the transducer.

16.1.3 Backup of the System Hard Drive

To prevent deterioration or loss of data stored in the system hard drive, create a backup copy
of the hard drive at regular intervals.

16.2 Maintenance Checks by Service

Engineer
The following checks must be performed to ensure and maintain system safety and
performance. Please contact Mindray Customer Service Department or sales representative
to schedule and carry out these checks.
Check Category Check Item
Interior of the system
Cleaning
Peripherals
Ground leakage current
Enclosure leakage current
Patient leakage current
Electric safety
Patient leakage current (110% supply voltage on
applied part)
Patient auxiliary leakage current
Monitor mounting mechanism
Control panel
Mechanical safety Mounting mechanism for the peripheral devices
Check other mechanical structures
Check the transducer appearance
Images in each mode
Image recording
Image recording by using the standard probe

System Maintenance 16-3

16.3 Consumables and Periodic Part
Replacement
This system contains some consumables and parts requiring periodic replacement.
Before replacing them, please contact Mindray Customer Service Department or sales
representative for instructions.

16.4 Troubleshooting
To ensure proper system operation and function, it is recommended that a maintenance and
inspection plan be established to periodically check the safety of the system. If any system
malfunction is experienced, contact Mindray Customer Service Department or sales
representative.
If any persistent system malfunction is experienced, e.g. an onscreen error message, blank
imaging screen, absent menus, please refer to the following table below. If the failure cannot
be eliminated, please contact Mindray Customer Service Department or sales representative.
1. Do not spill water or other liquid into the system while you
CAUTION: perform the cleaning. Otherwise it may result in
malfunction or electric shock.
2. When you want to clean probe connectors and TGC
sliders, contact Mindray Customer Service Department or
sales representative. Cleaning it yourself may result in
malfunction or degradation of the performance.

16-4 System Maintenance

„ Troubleshooting Table

No. Failure Cause Measure

After the „ Abnormal power system „ Verify that the plug has not
1
power supply or incorrect connection become loosened or
is turned on, of the power cord. dislodged from the back of
the power the system.
indicator does
not light on.
2 When the „ The interval between „ Turn off the system and
power turnoff and restart is too wait a minimum time of 1
indicator of the short – wait a minimum minute, then restart the
monitor is on time of 20 seconds. system.
and image is „ The monitor brightness „ Adjust the Contrast
blank. or contrast may be
improperly set.
The monitor „ The transmission power, „ Adjust the transmission
3
displays the overall gain or TGC power, gain or TGC
characters but controls are improperly control.
no images. set. „ Ensure proper probe
„ Verify that a probe is connection.
connected and / or fully „ Unfreeze the image.
connected.
„ The system is in the
frozen status.
The image „ The exam mode is not „ Select an appropriate
4
quality has correct. exam type.
degraded
„ The settings of the „ Adjust the settings of the
image post processing image via post processing
are not correct. or reset the post
„ The image presets are processing to the default
inappropriate values.
„ Reset the factory default
setups.
The button is „ Button blocked by too „ Check the control panel for
5
responseless much dirt the button being blocked
with the and press it several times
system to release it.
buzzing
„ Clean the button

System Maintenance 16-5

Appendix A Electrical Safety
Inspection
The following electrical safety tests are recommended as part of a comprehensive preventive
maintenance program. They are a proven means of detecting abnormalities that, if undetected,
could prove dangerous to either the patient or the operator. Additional tests may be required
according to local regulations.

All tests can be performed using commercially available safety analyzer test equipment.
These procedures assume the use of a 601PROXL International Safety Analyzer or
equivalent safety analyzer. Other popular testers complying with IEC 60601-1 used in Europe
such as Fluke, Metron, or Gerb may require modifications to the procedure. Follow the
instructions of the analyzer manufacturer.

The electrical safety inspection should be periodically performed every two years. The
safety analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of
line voltage and grounding, as well as total current loads.

A.1 Power Cord Plug

A.1.1 The Power Plug
Test Item Acceptance Criteria
The power plug pins No broken or bent pin. No discolored pins.
The plug body No physical damage to the plug body.
The power plug No physical damage to the strain relief. No
The strain relief
plug warmth for device in use.
The power plug No loose connections.
No physical damage to the cord. No
deterioration to the cord.
For devices with detachable power cords,
The power cord
inspect the connection at the device.
For devices with non-detachable power
cords, inspect the strain relief at the device.

A.2 Device Enclosure and Accessories

A.2.1 Visual Inspection
Test Item Acceptance Criteria
No physical damage to the enclosure and
The enclosure and accessories
accessories.

Electrical Safety Inspection A-1

 Test Item Acceptance Criteria
No physical damage to meters, switches,
connectors, etc.
No residue of fluid spillage (e.g., water,
coffee, chemicals, etc.).
No loose or missing parts (e.g., knobs,
dials, terminals, etc.).

A.2.2 Contextual Inspection

Test Item Acceptance Criteria
No unusual noises (e.g., a rattle inside the
case).
The enclosure and accessories No unusual smells (e.g., burning or smoky
smells, particularly from ventilation holes).
No taped notes that may suggest device
deficiencies or operator concerns.

A.3 Device Labeling

Check the labels provided by the manufacturer or the healthcare facility are present and
legible.
z Main unit label
z Integrated warning labels

A.4 Protective Earth Resistance

a. Plug the probes of the analyzer into the device’s protective earth terminal and protective
earth terminal of the AC power cord.
b. Test the earth resistance with a current of 25 A.
c. Verify the resistance is less than limits.
„ LIMITS
ALL COUNTRIES R = 0.2 Ω Maximum

A.5 Earth Leakage Test

Run an Earth Leakage test on the device being tested before performing any other leakage
tests.
The following outlet conditions apply when performing the Earth Leakage test.
z normal polarity (Normal Condition);
z reverse polarity (Normal Condition);
z normal polarity with open neutral (Single Fault Condition);
z reverse polarity with open neutral (Single Fault Condition).
„ LIMITS
For UL60601-1,
z 300 μA in Normal Condition.

A-2 Electrical Safety Inspection

 z 1000 μA in Single Fault Condition.
For IEC60601-1,
z 500 μA in Normal Condition.
z 1000 μA in Single Fault Condition.

A.6 Enclosure Leakage Test

The following outlet conditions apply when performing the Enclosure Leakage test.
z normal polarity (Normal Condition);
z reverse polarity (Normal Condition);
z normal polarity with open neutral (Single Fault Condition);
z reverse polarity with open neutral (Single Fault Condition);
z normal polarity with open earth (Single Fault Condition);
z reverse polarity with open earth (Single Fault Condition).
„ LIMITS
For UL60601-1,
z 100μA in Normal Condition.
z 300 μA in Single Fault Condition.
For IEC60601-1:
z 100μA in Normal Condition.
z 500 μA in Single Fault Condition.

A.7 Patient Leakage Current

Patient leakage currents are measured between a selected applied part and mains earth. All
measurements have a true RMS only.
The following outlet conditions apply when performing the Patient Leakage Current test.
z normal polarity (Normal Condition);
z reverse polarity (Normal Condition),
z normal polarity with open neutral (Single Fault Condition);
z reverse polarity with open neutral (Single Fault Condition).
z normal polarity with open earth (Single Fault Condition);
z reverse polarity with open earth (Single Fault Condition).

„ LIMITS

For BF applied parts,

z 100μA in Normal Condition.
z 500μA in Single Fault Condition.

A.8 Mains on Applied Part Leakage

The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage,
through a limiting resistance, to selected applied part terminals. Current measurements are
then taken between the selected applied part and earth. Measurements are taken with the
test voltage (110% of mains) to applied parts in the normal and reverse polarity conditions.
The following outlet conditions apply when performing the Mains on Applied Part test.
z Normal Polarity;

System Maintenance A-3

 z Reversed Polarity.

„ LIMITS

z For BF applied parts: 5000 μA.

A.9 Patient Auxiliary Current

Patient Auxiliary currents are measured between any selected Applied Part connector and the
remaining Applied Part connectors. All measurements may have a true RMS only response.

The following outlet conditions apply when performing the Patient Auxiliary Current test.
z normal polarity (Normal Condition);
z reverse polarity (Normal Condition);
z normal polarity with open neutral (Single Fault Condition);
z reverse polarity with open neutral (Single Fault Condition);
z normal polarity with open earth (Single Fault Condition);
z reverse polarity with open earth (Single Fault Condition).
„ LIMITS

For BF applied parts,

z 100μA in Normal Condition.
z 500μA in Single Fault Condition.

Note: Make sure the safety analyzer is authorized comply with requirement of IEC60601-1.
Follow the instructions of the analyzer manufacturer.

A-4 Electrical Safety Inspection

P/N: 046-001834-00 (V9.0)