DC-6

Diagnostic Ultrasound System

Operation Manual
[Basic Volume]

 2006 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.

Product Information
Product Name: Diagnostic Ultrasound System Model: DC-6 Issued date of this manual: 2006-12 Version: 1.1.

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 copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaptation or translation of this manual, in any manner whatsoever without the written permission of Mindray, is strictly forbidden.

are the registered trademarks or All other trademarks that

trademarks owned by Mindray in China and other countries. using them. They are the property of their respective owners.

appear in this manual are used only for editorial purposes without the intention of improperly

I-1

Responsibility on the Manufacturer Party

Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for safety, reliability and performance of this product only in the condition that:

all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel;

the electrical installation of the relevant room complies with the applicable national and
local requirements;

the product is used in accordance with the instructions for use.

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 injury of human health.

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: z z z any Mindray product which has been subjected to misuse, negligence or accident; any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed; any product of any other manufacturer.

I-2

Return Policy
Return Procedure
In the event that it becomes necessary to return this product or part of this product to Mindray, the following procedure should be followed: 1. Obtain return authorization: Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Returned shipments will not be accepted if the Mindray number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return. 2. 3. Freight policy: The customer is responsible for freight charges when this product is shipped to Mindray for service (this includes customs charges). Return address: Please send the part(s) or equipment to the address offered by Customer Service department

Company Contact Manufacturer: Address:

Phone: Fax:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen,518057, P.R.China +86 755 26582479 26582888 +86 755 26582934 26582500

EC-Representative: Address: Phone: Fax:

Shanghai International Holding Corp. GmbH(Europe) Eiffestrasse 80, 20537 Hamburg Germany 0049-40-2513175 0049-40-255726

I-3

Important Information
1. 2. The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product. 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 unacceptable environmental conditions. (4) Damage or loss due to use outside the territory in which the system was originally sold. (5) Damage or loss involving system purchased from a source other than Mindray or its authorized agents. 3. 4. 5. 6. This system shall not be used by persons other than fully qualified and certified medical personnel. Do not make changes or modifications to the software or hardware of this product. 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. The purpose of this system is to provide physicians with data for clinical diagnosis. The responsibility for diagnostic procedures lies with the physicians involved. Mindray shall not be liable for the results of diagnostic procedures. 7. 8. 9. Important data must be backed up on external recording media such as clinical records, notebooks etc. Mindray shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents. This manual contains Warnings regarding foreseeable potential dangers. Be alert at all times to dangers other than those indicated. Mindray shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions contained in this operation manual. 10. On the occasion of change of the administrator or manager for this system, be sure to hand over this operation manual.

I-4

Introduction
This operation manual describes the operating procedures for DC-6 diagnostic ultrasound system. To ensure safe and correct operation of the system, carefully read and understand the manual before operating the system.

1. Notation Conventions
In this operation manual, the following words are used in addition to the signal words related to the safety precautions (refer to "Safety Precautions"). Please read this operation manual before using the system. NOTE: Indicates information of interest to users of this system as to exceptional conditions or operating procedures.

CAUTION:

In U.S.A. federal Law restricts this device to be sale by or on the order of a physician.

CAUTION:

The DC-6 Diagnostic Ultrasound system is not intended for ophthalmic use. Its use in this clinical specialty is contraindicated.

I-5

2. Operation Manuals
The organization of the documents supplied with this system is shown below: Main unit operation manuals Describe detailed system information on preparation, operating procedures, maintenance checks, and functions. Describe the operating and sterilization procedures for transducers.

Transducer operation manuals

NOTE:

For practical applications, the following manuals are available: (1) (Advanced Volume) (2) (Acoustic Output Data)

3. Interface in this Operation Manual

Depending on the software version and configuration of each system, interfaces or menus may appear different from those shown in the manuals. Please refer to the displays of the system you purchased.

I-6

Safety Precautions
1. Meaning of Signal Words DANGER, WARNING,

In this operation manual, the signal words

CAUTION and NOTE 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 in death or serious injury. Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury. Indicates a potentially hazardous situation that, if not avoided, may result in property damage.

DANGER WARNING
CAUTION
NOTE

2.

Meaning of Safety Symbols

Symbol Type-BF applied part The ultrasound transducers connected to this system are Type-BF applied parts. The ECG module connected to this system is also a Type-BF applied part. "Attention" indicates the points requiring attention. Be sure to read the operation manual concerning these points before using the equipment. Description

S-1

3.

Safety Precautions

Please observe the following precautions to ensure patient and operator safety when using this system.

DANGER: Do not use flammable gasses such as anesthetic gas, oxygen or

hydrogen, or flammable liquids such as ethanol, near this product, because there is danger of explosion.

WARNING:
1. Do connect the plug of this equipment to the wall receptacle, and the plug must meet the ratings indicated on the rating nameplate. Using an adapter or multi-functional receptacle may affect the system grounding performance and thus causing the leakage current to exceed safety requirements. In addition, do connect the video printer to the auxiliary power socket of this system. And use the printing cable provided by this system to connect the printer. Otherwise, it may cause electric shock. 2 Be sure to connect the potential-equalization lead wire before inserting the equipment power plug into the receptacle. Also, be sure to remove the equipment power plug from the receptacle before disconnecting the wire to avoid electric shock. 3Connect the earth conductor only before turning ON the system. Disconnect the grounding cable only after turning OFF the system. Otherwise, electric shock may result. 4 For the connection of power and grounding, follow the appropriate procedures described in this operation manual. Otherwise, there is risk of electric shock. Do not connect the grounding cable to a gas pipe or water pipe, otherwise functional grounding may not be effective or there may be risk of a gas explosion. 5Before cleaning the system, be sure to disconnect the power cable from the outlet. If the system is defective, there is risk of electric shock.

S-2

6 No waterproof device is applied to this equipment. Do not use this equipment in any place with the possibility of water ingress. There is risk of electric shock if any water is sprayed on or into the equipment. If carelessly spray any water onto the equipment, contact the Mindray sales office, customer service department or representative. 7 Use the transducer carefully. In case that the body contacts the scratched transducer surface, immediately stop using the transducer and contact the Mindray sales office, customer service department or representative. There is risk of electric shock if using the scratched transducer. 8 Be careful not to let the patient contact the live parts of the ultrasound equipment or other devices, such as signal I/O ports. If the ultrasound equipment is defective, there is risk of electric shock. 9. Do not use the transducers other than those specified by Mindray. Otherwise, the equipment and the transducer may be damaged, causing an accident such as a fire in the worst case. 10. Do not subject the transducers to knocks. transducers may cause an electric shock. 11. Do not open the shell or front panel. If you open the shell when the system is powered on, there may be a short circuit or electric shock. 12. Do not use this system with using equipment at the same time such as an electrosurgical unit, high-frequency therapy equipment, or a defibrillator, etc. otherwise it may result in electric shock to the patient. 13. Use only the ECG leads provided with the ECG module, otherwise it may result in electric shock. 14. If this system needs to be moved, please hold the handle. If other parts of the system are held, it may cause damage due to the abnormal force. Do not push the system from the left/right side; otherwise it may be toppled over. Use of defective

S-3

15. Accessory equipment connected to the analogue and digital interfaces must be complied with the relevant IEC standards (e.g., IEC 60950 Safety of information technology Equipment Standard and IEC 60601-1 Medical Equipment standard). Furthermore all configurations should comply with the standard IEC60601-1-1. Any person, who connects additional equipment to the signal input or output ports and configures a medical system, is responsible for ensuring that the system complies with the requirements of IEC60601-1-1. If you have any problem, consult the technical services department of your local representative. 16. Prolonged and repeated use of keyboards can result in hand or arm nerve disorders for some individuals. Observe the local safety or health regulations concerning the keyboard use.

CAUTION: 1Precautions concerning clinical examination techniques:

(1) This system must be used only by qualified professionals. (2) This operation manual does not describe clinical examination techniques. Selection of the proper clinical examination technique must be based on specialized training and clinical experience. 2Malfunctions due to radiowaves: (1) Use of radiowave-emitting devices in the proximity of this medical electronic system may interfere with its operation. 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. (2) 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 installation and movement of the system: (1) Ensure to install the equipment horizontally and lock up the casters securely. Otherwise, it may move to cause injury. (2) Do not move the equipment from its sides; otherwise it may be toppled over and may injure people. (3) When you move the equipment on a slope, it shall be moved slowly by two people; otherwise it may happen to slide and severely injure people. (4) Do not sit on the equipment, because it may move and make people lose balance and fall.
S-4

(5) Dot not place any object on the monitor, because it may fall and injure people. (6) Fasten the peripheral devices before moving the equipment. Otherwise, the peripheral devices may fall and injure people. (7) When moving the equipment on steps, you shall prevent it from being toppled. 4Do not vibrate the equipment excessively (when moving the equipment); otherwise the mechanical parts (such as casters) may be damaged. If the equipment is often moved on a bumpy floor, contact the Mindray sales office, customer service department or representative. 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 an overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the buildings supply circuit may be tripped. 6Always keep the machine dry. Avoid transporting this machine quickly from the cold place to the warm place; otherwise condensation or water drops may be formed, causing short circuit. 7If the circuit breaker is tripped, it indicates that the machine or the peripheral devices have problems. In these cases, you cannot repair by yourself but should contact the Mindray sales office, customer service department or representative. 8 There is no risk of high-temperature burns during routine ultrasound examinations, even if, due to environment temperature and exam modes, the surface temperature of the transducer exceeds the body temperature of the patient. To prevent high-temperature burns, do not apply the transducer to the same region on the patient for a long time. Apply the transducer only for as long as required time for diagnosis. 9This device and its accessories are not disinfected and sterilized when they are out of the factory, so the user shall disinfect and sterilize transducers or biopsy brackets as per the manuals prior to use of transducers or biopsy brackets. After the sterilization or disinfection of accessories, chemicals must be washed out or gases must be discharged thoroughly from the accessories. Remaining residual chemicals or gases will not only result in damage to the accessories but also can be harmful to human bodies.

S-5

10Before examining a new patient, press the key to delete the patient information and data recorded in the image memory for the previous patient. Otherwise, the new data may be confused with the data of the previous patient. 11. Do not connect/disconnect the system and its accessories (such as printers or recorders) without turning OFF the power; otherwise it may cause damage of the equipment or electric shock. 12. Do not turn OFF the power supply of the system during printing, saving, or invoking; otherwise these processes may not be completed normally or files may be lost. 13. During operation, if the system is improperly powered off, it may result in data damage of the hard disk or system failure.

NOTE:

1. Do not use the machine in the vicinity of strong electromagnetic field (such as the transformer), which may affect the performance of the machine. 2. Do not use the machine in the vicinity of high-frequency radiation source, which may affect the performance of the machine or even lead to failure. 3. To avoid damaging the machine, do not use the machine in following environment: (1) Locations exposed to direct sunlight; (2) Locations subject to sudden changes in temperature; (3) Dusty locations; (4) Locations subject to vibration; (5) Locations near heat generators; (6) Locations with high humidity. 4. Turn ON the system only after the power has been OFF for more than 20 seconds. If the system is turned ON immediately after being turned OFF, the system may malfunction. 5. Turn OFF the auxiliary power switch or stop transmission through the Freeze key before connecting or disconnecting a transducer. system and/or the transducer may malfunction. If a transducer is connected or disconnected with an image displayed, the

S-6

6. After using the transducer, remove the ultrasound gel on it and place the transducer on the transducer holder. Otherwise, water in the gel may enter the acoustic lens, thus adversely affecting the performance and safety of the transducer. 7. You can record the registration data (including the hospital data and patient data). To ensure the security of the data, be sure to back up the data on external storage media. Data stored in the equipment may be lost due to improper operation or an accident. 8. Do not apply external force to the control panel (e.g. leaning against it). Otherwise it may damage the system. 9. If the system is used in a small room, the room temperature may rise. Therefore, proper ventilation shall be provided. 10. When disposing the system or any part of it, contact your Mindray representative. Do not dispose of this system without consulting Mindray. Mindray would bear no responsibility for damages resulting from disposal of this system without consulting Mindray. 11. Degradation of electrical and mechanical safety characteristics (such as generation of a leakage current or deformation/abrasion of mechanical parts) and of image sensitivity and resolution may occur after a period of time. To ensure normal operation of the system, it is recommended to sign a maintenance and service agreement to prevent accidents. 12. Output power outlet in the system is used to supply power for the recommended peripheral devices. Do not connect other devices to the outlet, otherwise the rated output power may be exceeded and failure may result. Maximum output power of the power outlet for peripheral devices is 350VA.

NOTE: The following definition of the WEEE label applies to EU member states only: The use of this symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased the product. * For system products, this label may be attached to the main unit only.

S-7

4.

Latex Alert WARNING:

Allergic reactions in latex (natural rubber) sensitive patients may 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 March 29, 1991)

Therefore, when choosing the transducer cover, we recommend that the user contact CIVCO directly for obtaining transducer cover, 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

S-8

5.

Warning Labels

Various warning labels are attached to this system in order to call the user's attention to potential hazards. The symbol on the warning labels indicates safety precautions. The warning labels

use the same signal words as those used in the operation manual. Detailed information about the warning labels is given in the operation manual. Read operation manual carefully before using the system. The name, pattern and the meaning of each warning label are described as follows: No. <1> Label Meaning (a) CAUTION: Do not sit on the system. (b) Before using the system, be sure to carefully read the relevant content of this operation manual. (c) DANGER: The system must not be used around flammable gasses.

<2>

(a) CAUTION: Do not place the system on a sloped surface. Otherwise the system may slide unexpectedly, resulting in person injury or the system malfunction. The system should be moved over a sloped surface by two persons to ensure safty. (b) CAUTION: The system shells must not be opened, because the high voltage inside may cause electric shock.

<3>

Beware of excessive stress exerted to the system.

S-9

CONTENTS
1 Overview ................................................................................................1-1
1.1 1.2 Intended Use .................................................................................................. 1-1 Model Introduction .......................................................................................... 1-1

Product Specifications .........................................................................2-1

2.1 2.2 2.3 Image Modes .................................................................................................. 2-1 Environmental Conditions ............................................................................... 2-1 External Dimensions and Weight .................................................................... 2-1

System Configuration...........................................................................3-1
3.1 3.2 3.3 3.4 Standard Configuration ................................................................................... 3-1 Transducers Available..................................................................................... 3-1 Optional Units ................................................................................................. 3-2 Supported Peripheral Devices ........................................................................ 3-2

Introduction ...........................................................................................4-1
4.1 4.2 4.3 4.4 4.5 4.6 Introduction of Each Unit................................................................................. 4-1 I/O Panel......................................................................................................... 4-3 Power Panel ................................................................................................... 4-4 ECG Panel...................................................................................................... 4-5 Control Panel .................................................................................................. 4-6 Symbols ........................................................................................................ 4-13

Placement and Connection ..................................................................5-1

5.1 5.2 5.3 5.4 5.5 5.6 Placing the System ......................................................................................... 5-1 Connecting the Power Cable and Protective Earth......................................... 5-1 Connecting/Disconnecting a Transducer ........................................................ 5-4 Connecting/Removing a USB Memory Device ............................................... 5-5 Connecting a Footswitch................................................................................. 5-6 Connecting a graph/text printer....................................................................... 5-6

Power ON/OFF.......................................................................................6-1
6.1 6.2 6.3 Power ON ....................................................................................................... 6-1 Restart the System ......................................................................................... 6-3 Power OFF ..................................................................................................... 6-3

Basic Screen and Operation ................................................................7-1

7.1 Basic Screen................................................................................................... 7-1
C-1

7.2

Basic Operations of Dialog ............................................................................. 7-5

Patient Information ...............................................................................8-1

8.1 8.2 8.3 Entering/Exiting Patient Information................................................................ 8-1 Patient Information Input................................................................................. 8-2 Importing Patient Information Worklist ............................................................ 8-5

Exam Modes ..........................................................................................9-1

9.1 9.2 9.3 Instruction of Exam Modes ............................................................................. 9-1 Selecting Exam Modes ................................................................................... 9-2 Presetting Exam Modes.................................................................................. 9-2

10 Image Modes .......................................................................................10-1

10.1 Categories of Image Modes.......................................................................... 10-1 10.2 Switching Between Image Modes................................................................. 10-2 10.3 Image Adjustment ......................................................................................... 10-3 10.4 Image Parameter Preset............................................................................. 10-14

11 Cine Review.........................................................................................11-1
11.1 Entering/Exiting Cine Review........................................................................ 11-1 11.2 Cine Review in the B/Color Mode ................................................................. 11-2 11.3 Cine Review in the PW/M Mode ................................................................... 11-2 11.4 Linked Cine Review ...................................................................................... 11-2 11.5 Setting Region of Auto Review ..................................................................... 11-3

12 Measurements .....................................................................................12-1
12.1 Basic Operation ............................................................................................ 12-1 12.2 General Measurements ................................................................................ 12-2 12.3 Application Measurements............................................................................ 12-5

13 Comments ...........................................................................................13-1
13.1 Entering/Exiting Comments .......................................................................... 13-1 13.2 Comment Menu ............................................................................................ 13-1 13.3 Adding Comments ........................................................................................ 13-2 13.4 Moving Comments ........................................................................................ 13-5 13.5 Modifying Comments .................................................................................... 13-5 13.6 Deleting Comments ...................................................................................... 13-6 13.7 Comment Preset........................................................................................... 13-7

14 Body Marks..........................................................................................14-1
14.1 Entering/Exiting Body Mark Mode................................................................. 14-1 14.2 Categories of Body Marks............................................................................. 14-1

C-2

14.3 Body Mark Menu........................................................................................... 14-2 14.4 Adding Body Marks....................................................................................... 14-3 14.5 Moving Body Marks ...................................................................................... 14-4 14.6 Deleting Body Marks..................................................................................... 14-4 14.7 Body Mark Preset ......................................................................................... 14-5

15 Patient File Management ....................................................................15-1

15.1 Image File Formats ....................................................................................... 15-1 15.2 Storing Image Files ....................................................................................... 15-2 15.3 Image Review and Analysis .......................................................................... 15-3 15.4 iVision ........................................................................................................... 15-3 15.5 Search Patient .............................................................................................. 15-4 15.6 iStation .......................................................................................................... 15-5 15.7 Disk Management......................................................................................... 15-6

16 Preset ...................................................................................................16-1
16.1 Entering/Exiting Preset ................................................................................. 16-1 16.2 System Preset .............................................................................................. 16-2 16.3 Exam Mode Preset ....................................................................................... 16-3 16.4 Image Parameter Preset............................................................................... 16-3 16.5 Comment Preset........................................................................................... 16-3 16.6 Body Mark Preset ......................................................................................... 16-3 16.7 Measurement Preset .................................................................................... 16-4 16.8 Preset Data................................................................................................... 16-4 16.9 Maintenance ................................................................................................. 16-4

17 Biopsy Guide .......................................................................................17-1

17.1 Entering or Exiting Biopsy Menu ................................................................... 17-1 17.2 Displaying Biopsy Guide Lines ..................................................................... 17-1 17.3 Verifying the Biopsy Guide line ..................................................................... 17-2

18 ECG ......................................................................................................18-1
18.1 ECG Connection........................................................................................... 18-2 18.2 Displaying ECG Signal.................................................................................. 18-2

19 VCR ......................................................................................................19-1
19.1 Record .......................................................................................................... 19-2 19.2 Replay........................................................................................................... 19-3

20 System Maintenance ..........................................................................20-1

20.1 Daily Maintenance ........................................................................................ 20-1

C-3

20.2 Maintenance Checks by Service Engineer ................................................... 20-3 20.3 Consumable Parts and the Parts of Periodic Replacement .......................... 20-4 20.4 Troubleshooting ............................................................................................ 20-4

21 Acoustic Output ..................................................................................21-1

21.1 Concerns with Bioeffects .............................................................................. 21-1 21.2 Prudent Use Statement................................................................................. 21-1 21.3 ALARA Principle (As Low As Reasonably Achievable) ................................. 21-2 21.4 MI/TI Explanation.......................................................................................... 21-2 21.5 Acoustic Power Setting ................................................................................. 21-5 21.6 Acoustic Power Control................................................................................. 21-6 21.7 Acoustic Output ............................................................................................ 21-7 21.8 Measurement Uncertainty............................................................................. 21-9 21.9 References for Acoustic Power and Safety................................................... 21-9

22 Measurement Accuracy......................................................................22-1 23 Safety Classification...........................................................................23-1 24 Guidance and Manufacturer's Declaration .......................................24-1 Appendix A DICOM .................................................................................... A-1

C-4

1
1.1 1.2
DC

Overview
Intended Use

The DC-6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates, and it is intended for use in abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, pediatric, neonatal cephalic, musculoskeletal (general and superficial), and intraoperative (liver, gallbladder, pancreas exams.

Model Introduction
Model code Product code

NOTE: The functions described in operation manuals of this system, are not provided for all models sold in all regions. The functions may vary depending upon the specific system you purchased.

1-1

2
2.1
B mode M mode Color mode Power mode PW mode

Product Specifications
Image Modes

2.2

Environmental Conditions
Power supply voltage Power supply frequency Power consumption : 100 to 127V or 220 to 240V : 50/60Hz : 800VA

(1) Power supply

(2) Operating conditions Ambient temperature Relative humidity Atmospheric pressure : 0C to 40C : 30% 85% (no condensation) : 700 hPa to 1060 hPa

(3) Storage and transportation conditions Ambient temperature Relative humidity Atmospheric pressure : -20C to 55C : 30% to 95% (no condensation) : 700 hPa to 1060 hPa

WARNING:

Do not use this system in the conditions other than those specified.

2.3

External Dimensions and Weight

External dimensions: 1390mm (height) 790mm (length) 480mm (width) Weight: Approx. 132 kg.

2-1

3
3.1
1 2 3 4 Main unit Monitor

System Configuration
Standard Configuration

Accessories Transducers of standard configuration

3.2
Model
3C5 3C5A 3C1 6CV1 7L4

Transducers Available
Type
Convex Convex Convex Convex Linear

Intended Use
Gynecology, pediatrics Gynecology, pediatrics obstetrics, obstetrics, abdomen, abdomen, abdomen,

Region Applied Body surface Body surface Body surface Transvaginal, transrectal Body surface

Gynecology, obstetrics, pediatrics, cardiology

Gynecology, obstetrics, urology Small parts, neonatal cephalic, peripheral vascular, superficial surface, general musculoskeletal Small parts, neonatal cephalic, peripheral vascular, superficial surface, general musculoskeletal Small parts, neonatal cephalic, peripheral vascular, superficial surface, general musculoskeletal Small parts, neonatal cephalic, peripheral vascular, superficial surface, general musculoskeletal Intraoperation (liver, gallbladder, pancreas), small parts

7L4A

Linear

Body surface

7L6

Linear

Body surface

10L4

Linear

Body surface

7LT4

Intraoperative T-type

Intraoperation, Body surface

3-1

System Configuration

3.3
No
1 2 3

Optional Units
Name
Footswitch DICOM module ECG module

Model
971-SWNOM DICOM 3.0 /

Remark

The ECG module contains the relevant hardware and software, as well as ECG leadwires. ECG lead part number: AHA: 0010-20-12126 IEC: 0010-20-12127

HPRF module

3.4
No
1 2 3

Supported Peripheral Devices

Name
B/W video printer Color video printer Graph/text printer

Model Recommended
Sony UP-897MD Mitsubishi P93W Sony UP-20; Mitsubishi CP-910E HP DeskJet 5652 HP DeskJet 5650 HP DeskJet 3820 HP DeskJet 1280 HP DeskJet 6548 HP DeskJet 6848 HP DeskJet 450 HP Business InkJet 1000 HP Business InkJet 1200 Sony SVO-9500MD2

VCR recorder

WARNING:
DC-6 complies with IEC60601-1-2:2001+A1:2004, RF emission meets the requirements of CISPR11 Class B. In a domestic environment the customer or the user of DC-6 should assure that it is connected to Class B peripheral equipment; otherwise the system may cause radio interference in which case the customer or the user of DC-6 may be required to take adequate measures.

3-2

4
4.1

Introduction
Introduction of Each Unit

4-1

Introduction

No <1> <2> <3> <4> <5> <6> <7>

Name Monitor Minor panel Main panel Keyboard CD-RW

Function Displays the images and parameters during scanning Human-machine interface, operation control Human-machine interface, operation control Human-machine interface, operation control Rewritable CD drive

Space for placing Used for placing B/W video printer video printer Transducer socket Interface connecting transducers and the main unit There are 3 active sockets and one dummy socket.

<8> <9>

Casters Handle

Used for fixing or moving the system Used for pushing the system Used for placing transducers temporarily Used for connecting the ECG cable and footswitch, etc.

<10> Transducer holder <11> ECG panel

<12> Table for placing Used for placing color video printer color printer <13> I/O panel <14> Power panel <15> USB interface <16> MIC interface <17> Space for placing <18> Power switch Interface panel for input and output signals Electrical interface panel Used for USB devices (The upper is used for USB devices, while the lower is for expansion.) Reserved Used for placing video recorder Used for turning on/off the power supply

4-2

Introduction

4.2

I/O Panel
<1> <9> <13> <17>

<2>

<5>

<10>

<14>

<18>

<3>

<6>

<11>

<15>

<19>

<7> <4> <8>

<12>

<16>

<20>

No
<1> <2>,<3> <4> <5> <6> <7>,<8> <9>,<10> <11>,<12> <13>,<14> <15>,<16> <17>,<18> <19>,<20>

Symbol

Function
Connects parallel port devices Ethernet interface System reset Serial port Control port for color video printer USB port (The lower is used for USB devices, while the upper is for expansion.) Used for VGA I/O Used for RGB component video I/O Used for separate video I/O Used for compound video I/O Used for stereo audio I/O

4-3

Introduction

4.3

Power Panel

<1>

<3> <4>

<5>

<2>

No
<1> <2> <3> <4> <5>

Name
Ground terminal

Function
Used for grounding connection

Equipotential terminal Used for equipotential connection Power outlet Circuit breaker Power inlet Power supply for optional peripheral devices Used for cutting off power supply of the system AC power inlet

4-4

Introduction

4.4

ECG Panel

No
<1> <2> <3>

Name

Function

ECG lead signal input Used for connecting ECG leads and acquiring interface ECG signals External ECG input port signal Used for connecting the signal output port of ECG monitor Used for connecting the footswitch

Footswitch interface

4-5

Introduction

4.5

Control Panel

4.5.1 Main panel

No <1> <2> <3> <4> <5> <6> <7> <8> <9> <10> <11> <12> <13>

English Name Patient Info / / SV Filter PW Steer Angle Scale Baseline Doppler Freq Color IP Color Filter

Function Starting an exam of a new patient Entering the patient information input screen Power indicator Hard disk indicator Adjusting the size of sample volume Adjusting wall filter frequency in the PW mode Adjusting SV steering angle of a linear transducer in the PW mode Adjusting SV corrected angle in the PW mode Adjusting pulse repetition frequency in the Color/Power/PW mode Adjusting baseline position in the PW/Color mode Adjusting transmitting frequency in the Color/Power/PW mode Selecting IP parameter combination in the Color/Power mode Selecting wall filter in the Color/Power mode
4-6

Introduction

<14> <15> <16> <17> <18> <19> <20> <21> <22> <23> <24> <25> <26> <27> <28> <29> <30> <31> <32> <33>

Color Steer Focus IP Freq/THI B Steer CW PW B Color M Update Dual Quad Power Save Cine Review Save Img Cine iTouch Depth/Zoom

<34> <35> <36>

Freeze Menu

Adjusting ROI steering angle of a linear transducer in the Color/Power mode Adjusting focus position for B images Selecting IP for B images Adjusting the current transducer frequency and harmonic frequency Adjusting steering scan of a linear transducer Reserved Press the key to enter the PW mode, and rotate the key to adjust gain of a PW image Entering the B mode by pressing it, and adjusting the gain by turning it Entering the Color Doppler mode by pressing it, and adjusting the gain by turning it Pressing the key to enter the M mode, and rotate the key to adjust gain of an M image Switching mode image in M/B mode or PW/B mode. Entering Dual-split screen display, or switch live image window in Dual. Entering Quad-split screen display, or switch live image window in Quad. Entering the Power Doppler mode by pressing it, and adjusting the gain by turning it Quickly saving cine files to the default region of the internal hard disk in the preset image format Reviewing the image files of the current patient or the last patient. Quickly saving image files to the default region of the internal hard disk in the preset image format. In the frozen status, entering/exiting the manual Cine playback status. Optimizing images by pressing this key When the Depth indicator lights on, the knob is used for adjusting image depth by turning it; when the knob is pressed down and the Zoom indicator lights on, the knob is used for adjusting magnification factor by turning it. Freezing or unfreezing an image Invoking or closing the menu corresponding to the current status The multifunction knob is used with the current status and trackball, and it has many functions. Please refer to the operation description for details. Returning to the previous operation Changing the active point of the caliper during measurement; or opening the comment library in the comment status Confirming, equivalent to the left-button of the mouse

<37> <38>

Back Change

<39>

Set

4-7

Introduction

<40> <41> <42> <43> <44> <45> <46> <47> <48> <49>

Caliper Print trackball Arrow Comment Report Body Mark Exit Clear Measure

Starting general measurement function Printing the screen image (video print control) Adjusting the cursors position on the screen Adding comment arrows, and the arrow orientation is adjusted through the multifunction knob. Pressing the key to start the comment function, and the system enters the comment status. Entering the current patient report Starting the body mark function by pressing it and the system enters the body mark edit status. Exiting the current status and returning to the previous status. Clearing all comments, measurement calipers, Clearing the selected body mark on image. Starting application measurement functions.

4-8

Introduction

4.5.2 Minor panel

No
<1> <2> <3> <4> <5> <6> <7> <8> <9> <10> <11> <12> / / / /

English Name

Function
Reserved for future use, can be defined Reserved for future use, can be defined Reserved for future use, can be defined Reserved for future use, can be defined Used for data recording Entering or exiting the ECG menu Entering the patient files management Switching between effective transducers connected and its exam mode. Adjusting time gain compensation Adjusting Acoustic Output Adjusting ECG signal position and ECG gain Adjusting Doppler sound volume

Record ECG iStation Probe TGC A.Power ECG Volume

4-9

Introduction

4.5.3 Keyboard

Ejection of the keyboard Push the edge of the keyboard inward slightly, and then the keyboard

automatically ejects outward. At this time the light under the main control panel is bright automatically to lighten the keyboard. Retraction of the keyboard Push the keyboard inward, and when a click sound is heard, the keyboard is retracted.

4-10

Introduction

Functions of the keys

No
<1> <2> <3> <4> <5> <6> <7> <8> <9> <10> <11> <12> <13> <14> <15> <16> <17> <18> <19> <20> <21>

Key
Enter Esc Tab Space Caps Lock Num Lock Shift Ctrl Alt Pause/Break Home End PgUp PgDn Arrow Ins Del Back Space PrtSc Win Logo Application

Function Receiving the input data; or moving the cursor to the head of next row of the text or the input field.
Same as that of theExitkey Jumping to the next operation Inserting a space Switching between upper and lower case letters Switching between numerics and other characters Press theShiftkey and another key simultaneously, and then upper and lower case letters or upper and lower characters can be switched; Shift Set; Combined shortcut, Ctrl Set; Combined key / Moving the cursor to the head of the row, or the leftmost side of an edit unit. Moving the cursor to the tail of the row, or the rightmost side of an edit unit. Turning pages upward or leftward Turning pages downward or rightward Moving the cursor position Switching between inserting and overwriting characters Deleting characters after the cursor Deleting characters before the cusor / / /

NOTE: / symbols represent the keys are undefined.

4-11

Introduction

Functions of the keys F1 to F12

No <1> <2> <3> <4> <5> <6> <7> <8> <9> F1 F2 F3 F4 F5 F6 F7 F8 F9 Key / Quickly starting the patient information screen (identical to the Info key) Quickly starting the diagnosis report screen (identical to the Report key) Quickly starting the comment status (identical to the Comment key) / / / / Switching to the video replay menu Quickly starting preset function Turning on/off the display of biopsy guide line / Function

<10> F10 <11> F11 <12> F12

NOTE: for the keys undefined, the user can define functions for them as per needs and habit. Refer to Preset chapter for details.

4-12

Introduction

4.6

Symbols
This system uses the symbols listed in the following table, and their meanings

are explained as well. Refer to Safety Precautions for safety symbols.

Symbol Type-BF device

!

Meaning

Refer to relevant content in the Operation Manual, to avoid safety accidents Dangerous voltage AC (alternate current) Functional earth Equipotentiality Protective earth Breaker ON/OFF Power ON/OFF Footswitch Transducer socket Network port Parallel port Serial port S-VIDEO signal interface VIDEO signal interface VGA signal RGB signal External signal input Remote control port USB

4-13

Introduction

System reset Audio signal Microphone input jack Product serial number Manufacture date
Manufacturer Authorized representative in the European community The device is fully in conformance with the Council Directive Concerning Medical Devices 93/42/EEC. The number adjacent to the CE marking (0123) is the number of the EU-notified body that certified meeting the requirements of Annex II of the Directive.

4-14

5
5.1

Placement and Connection

Placing the System

Please read and understand the safety precautions before placing the system.

(1) Unlock the four casters. (2) Move the system by holding the handle. (3) When the system is placed in a desired position, lock the four casters. (4) Leave at least 20cm at the back and both sides of the system.

CAUTION: Ensure enough space at the back and both sides of the system;
otherwise failure may result due to the temperature rise in the system.

5.2

Connecting the Power Cable and Protective Earth

5.2.1 Connecting the power cable

The power system of the device must meet the following requirements: 100 to 127V or 220 to 240V 50/60Hz Power consumption: greater than 800VA. The method of connection is described as follows: (1) Push the retaining clamp upward, and put the power cable into the receptacle, as shown in the figure below.
Retaining clamp

Recepticle

Power cable

5-1

Placement and Connection

(2) Push the retaining clamp downward, and lock the power cable, as shown in the figure below.

5.2.2 Protective earth terminal

The power cable of the system is a three-wire cable. The grounding terminal should be connected with the protective earth cable. Be sure that the power earth protection can work normally.

WARNING:
1. Do not connect the three-wire cable of the system with a two-wire plug; otherwise it may result in electric shock.

2 Be sure to connect this system and its peripheral devices to wall receptacles, which shall meet the rated power requirement written on the plate. Adapters or multifunctional receptacles may cause the leakage current to exceed the safety requirement. In addition, please connect the video printer to the special auxiliary power outlet of this system, and use the cable provided with this system to connect the printer. Other cables may result in electric shock.

5-2

Placement and Connection

5.2.3 Equipotential terminal

The symbol of represents the equipotential terminal that is used for balancing the

protective earth potentials between the system and other electrical equipment. Refer to Power Supply Panel for the relevant explanation.

WARNING:
1. Be sure to connect the equipotential lead wire before inserting the power plug into the receptacle; also, be sure to remove the power plug from the receptacle before disconnecting the equipotential lead wire; otherwise, it may cause electric shock. 2. When you want to connect another device to this system, you should use the equipotential cable to connect each of equipotential terminals; otherwise electric shock may occur.

3. Information concerning the functional earth terminal (

):

The user should connect the system according to the local regulations. 4. Connect the earth cable only before turning ON the system. Disconnect the earth cable only after turning OFF the system. Otherwise, electric shock may occur. 5.
Do not connect this system to the outlets with the same circuit breakers and fuses that control the current to devices such as life-support systems. Once this system fails or generates an overcurrent, or once there is an instantaneous current at power on, the circuit breakers and fuses of the buildings supply circuit may be tripped.

5-3

Placement and Connection

5.3

Connecting/Disconnecting a Transducer

CAUTION:
1. Turn off the power of the system or freeze the image (through the Freeze key) before connecting/disconnecting of the transducer. Otherwise, failure may occur. 2. When connecting or disconnecting a transducer is, place it in the transducer holder and hang the cable on the hook, to prevent the transducer from falling off and damaging. 3. When using a transducer, hang the cable on the hook, to prevent the cable from twisting and damaging. 4. Only use the transducers provided by Mindray. Otherwise it may result in damage or cause a fire.

5.3.1 Connecting a transducer WARNING:

Ensure the transducer, cable and connector to be in the normal

status (free from crack and peeling) before connecting the transducer. If a defective transducer is used, electric shock may occur.

1. Turn the lock of the transducer connector to keep it in the horizontal position; keep the cable upward and insert the connector into the socket, and then press it tightly.

2.

Turn the lock 90clockwise to the vertical position. See the figures below.

Unlock

Lock

5-4

Placement and Connection

5.3.2 Disconnecting a transducer

Turn the locking lever 90counterclockwise to the horizontal position, and pull out the transducer connector along vertical direction, as shown in the figure below.

5.4 Connecting/Removing a USB Memory Device

1 When a USB memory device is connected to the ultrasound system through a USB port, the symbol appears in the lower right corner of the screen. , and press

2 To remove the USB memory device, move the cursor onto theSetkey. A dialog box pops up.

3 Select the memory device to be removed, and press the [OK] button to remove it.

WARNING:

Do not remove a USB memory device directly; otherwise it

may damage the USB memory device and the ultrasound system.

5-5

Placement and Connection

5.5

Connecting a Footswitch

The footswitch can control Freeze operation and Print operation remotely. Connect the footswitch connector to the port at the bottom of the ECG panel, as shown in the figure below, and then rotate the connector to fix it in position.
Footswitch port

Footswitch

5.6

Connecting a graph/text printer

As shown in the figure below, a graph/text printer has a power cable and data cable, and the power cable shall be directly connected to a wall receptacle as required. The printer model shall be a specified model supported by this system. Refer to Recommended Peripheral Devices for specific models.

Power cable Data cable

The procedures are described as follows: 1 Connect the data cable to USB port of the system. 2 Connect the power cable to a wall receptacle. 3 Turn on the power of the ultrasound system. 4 The installation process is complete.

5-6

6
6.1

Power ON/OFF
Power ON

CAUTOIN:

To ensure the safe and effective operation of the system, you need to perform daily maintenance and checks. If you find any abnormity, shut down the machine immediately and contact the Mindray sales office, customer service department or representative. If you use the abnormal equipment, it may harm patients and damage the equipment.

6.1.1 Checking before power ON

Before the system is turned on, please check the system as the following items:
No <1> <2> <3> <4> <5> <6> <7> Check Item The temperature, relative humidity and atmospheric pressure shall meet the requirements of operating conditions. There shall be no condensation. There shall be no distortion, damage or dirt on the system and peripheral devices. If any dirt is found, cleaning shall be performed as per Cleaning the system. There shall be no unsecured casters, monitor and main panel or loose screws. The locks of the casters shall work normally. There shall be no damage concerning the cables (including the power cable), and connection of connectors shall be secured. The transducers and transducer cables shall be free of damage or stains. If any stain is found, it shall be cleaned, disinfected and sterilized in terms of the operation manual of the transducers. No sundries are allowed on the main panel. Check the outlet of the auxiliary power supply of this equipment and all I/O ports, ensuring there is no abnormity such as damage or occlusion by foreign objects. There shall no obstacles around the equipment and its air vent. Regarding cleaning, disinfection and sterilization of the transducers, refer to the operation manual of the transducers. The field and environment shall be clean.

<8> <9>

<10> <11>

6-1

Power ON/OFF

6.1.2 Turning on the power

First check whether the circuit breaker is switched on. If not, switch on the breaker. After the power indicator on the main panel is on, turn on the power (on the left side of the machine) to start the system. After the normal startup, the screen of the image is displayed. Check if the equipment is started normally according to the following items: No <1> <2> <3> <4> <5> <6> Check Item There shall no abnormal sound, smell or overheating. There shall no error message displayed. There shall no evident noise, discontinuous display or black area on a B-mode image. Check if there is abnormal heat on the surface of the transducer during operation. The keys and knobs on the panels and keyboard can function normally. The date and time of the system are identical to those of the current exam, and are correctly displayed.

WARNING:
1. If a transducer giving abnormal heat is used, it may burn the patient. 2. If any abnormity is detected, it indicates that the equipment is defective. In this case, shut down the machine immediately and contact your service representative.

NOTE: When you start the system or switch between transducers, you will hear a sound of sputtering, which is regarded as normal.

6-2

Power ON/OFF

6.2

Restart the System

When any of the following abnormalities occurs, the user can disconnect the power cable of the system from the wall receptacle, and then restart the system after several minutes: An error message is displayed and does not disappear.

The screen display is abnormal. The system operations cannot be executed.

6.3

Power OFF

If the system will not be used for a long time, the power shall be turned off. Perform the following operations: (1) Place the transducer on the transducer holder and hook the transducer cable.

(2) Turn off the power switch of the system on the left side. If the system will not be used for a long period of time, please cut off the circuit breaker on the power panel (namely, pull down the switch of the breaker). Do not directly switch off the breaker without turning off the power switch first, since it may cause system failure.
(3) Turn off all the power supplies of the peripheral devices connected to this equipment.

6-3

7
7.1
shortcut tool field.

Basic Screen and Operation

Basic Screen

The monitor is to display the ultrasound images, parameters and operation menus. The menus and parameters vary depending upon image scanning modes. The basic screen is generally divided into: information field, image field, active window field, menu and image parameter field, measurement result field, status prompt field, and

Information field

Menu & image parameter field Image field

Measurement Active window field Status prompt field Shortcut tools field result field

7-1

Basic Screen and Operation

7.1.1 Information field

The information field displays manufacturer logo, hospital name, patient information, system date and time, transducer model and current frequency, current exam mode, and freezing mark etc.

Manufacturer logo The Mindrays logo is displayed in the upper left corner of the screen.

Hospital name The hospital name is displayed on the screen, and it can be set through the General item in the system preset dialog box. Patient information
The patient name, ID, Gender and Age are displayed on the screen, and they can be entered through the patient information input dialog box or loaded old patient.

System date and time The system date and time are displayed on the screen, and the date, time and format can be set through the General item in the system preset dialog box. Transducer model The model of the currently used transducer is displayed on the screen. The transducer model can be selected in the transducer selection dialog box. Current exam mode
The currently used exam mode, such as adult abdomen etc. is displayed.

7.1.2 Image field

The image field displays ultrasound image, comment, measurement caliper, body mark, scale mark, grey bar and color bar.

Ultrasound image The display width and shape of an image depend upon the selected transducers and setups. And it already displays depth scale indication, focus mark, and selected grey bar or color bar. Comments and body marks The comments are used to assist analysis and explanation of images, and they consist of comment texts and comment arrows. The body marks indicate the probing position on patient body and probing orientation of a transducer, when an image is scanned. Measurement caliper
In the general measurement status and measurement statuses of various applications, the measurement calipers are displayed in the image field during measurement. However, after some operations are performed (e.g., unfreezing operation), measurement calipers will be cleared.
7-2

Basic Screen and Operation

7.1.3 Menu and image parameter field

Menus
The menus are grouped into image control menus, measurement menus and control program menus. The menus are generally in the status of suspension, and the user can press theMenukey to open the suspended menus. After a menu is suspended, the position of the menu will display the current image parameter information.

Image control menu

Most of the image control menu items belong to parameter-adjusting menu items. Pressing theSetkey orBackkey can switch between parameter values or options.

Measurement menu
The measurement menus are different depending upon image modes and applications measurement packages. Most of measurement menu items belong to command-executing menu items. Pressing theSetkey on a menu item can start a measurement. The menu items with a submenu work in the same way. Move the cursor onto a menu item, its submenu automatically opens, and pressing a submenu item can start a measurement.

Control program menu

The control program menu is used to start a new program or menu of screen operation, such as preset menu and file menu. The control program menu generally belong to command-type menu, and pressing theSetkey can start a new screen. For the [OK] and [Cancel] buttons on the screen, pressing the [OK] button can confirm the information changes on the screen and exit the screen; pressing the [Cancel] button can cancel the information changes to return to the previous information on the screen and remain in the current status and exit the screen.

Image parameter display

After the menu is suspended, the position of the menu displays image parameters, as shown in the figure below (as an example).

B and C on the left side respectively represent B mode and Color mode, while the parameters refer to the parameters in the corresponding modes, such as transducer frequency (e.g., 2.5M), gain (e.g., G62 and G19), dynamic range (e.g., DR65), depth (e.g., D2.1), IP, PRF, and wall filter (WF1), etc. The image parameters can be changed in this field through locating cursor on the parameter and then rotating the multi-functional knob.

7-3

Basic Screen and Operation

7.1.4 Measurement result field

The measurement result field displays the results of measurements and calculations. The measurement result is generally displayed in real time. Before the measurement caliper is fixed, moving the cursor can refresh the result in real time. After the measurement caliper is fixed, the result will be constantly displayed.

7.1.5 Active window field

The active window field displays body mark selection window, image review window, and ECG waveform display (only valid for the system with ECG module). It also displays acoustic output parameters.

Acoustic output parameters

The acoustic output parameters include MI/TI real time parameters and acoustic power level (such as AP1). Refer to Acoustic Output section for MI/TI. Acoustic power level represents ultrasound transmitting power, and it can be adjusted through theA.powerkey on the main panel.

7.1.6 Status prompt field

The left side of the field displays help information in the current status (such as free cursor status, Cine review status, SV or ROI adjusting status etc,), as shown in the figure below:

SV adjusting status

Zoom status

Free cursor status

Cine review status

The right side of the field shows USB device connecting information, recorder status, and network status etc..

7.1.7 Shortcut tool field

The shortcut tool field, right below the image, displays shortcut tools as per the current status (an example is taken as follows):

Move the cursor onto a shortcut tool button, and the name of the tool will appear. Press

Set or Back key to adjust values.

7-4

Basic Screen and Operation

7.2 Basic Operations of Dialog

The schematic of a dialog box is shown in the figure below. A dialog box generally consists of several parts as shown in the figure.

Composition Title Bar

Page tab

Description The title bar is used to give a general description for the content and function of the dialog box. For some dialog box, contents are designed to distribute on several pages. To set parameters, it needs to select pages and switch between pages. Pressing theSetkey on the page tab can switch to the corresponding page.

Adjustable items

Pressing theSet or Backkey can adjust the values. When the operation of a dialog box is complete, the user can

OKandCancel

press theOKorCancelbutton to save or cancel the operation, and close the dialog box.

Drag a dialog box

To drag a dialog box, the method is described as follows:

1. Roll the trackball to move the cursor onto the title bar of the dialog box, and at this time the cursor becomes ; press theSetkey. 2. Roll the trackball, and there is a rectangular frame, the same size as that of the dialog box, moves with the cursor; position the rectangular frame to the place where the dialog box will be moved. 3. Press theSetkey, and the dialog box moves to the desired position. 4. After step 2, pressing theBackkey can cancel the operation of dragging the dialog box and the dialog box remains in the original position.

7-5

8
CAUTION:

Patient Information

Although the user can start scanning a patient without entering patient information, it is recommended to enter patient information before an image is scanned. Thus the system can create the patient database, to avoid the data confusion.

Before examining a new patient, press the Patient key to update

patient ID and information; Otherwise, the new data may be confused with the data of the previous patient.

8.1

Entering/Exiting Patient Information

To enter the patient info screen: When examining a new patient, press the Info. key or F2 key. Or move the cursor onto the patient info display field, and press theSetkey to enter the Patient Info dialog box.

To exit the patient info screen: In the Patient Info dialog box, clicking the [Ok] button can save the patient information and exit the dialog box; clicking the [Cancel] button or pressing theExit key or pressing Infokey again will not save the current information, but exit the dialog box.

8-1

Patient Information

8.2

Patient Information Input

8.2.1 Basic patient information

In the new patient exam, pressing the Info.can enter the patient info screen, as shown in the figure below:

The operation of patient information input is described as follows:

ID

If the user selects the Auto ID item following the patient ID column, and the system will automatically create patient ID. If the user deselects the Auto ID item following the patient ID column, and the system will default it as manual input of patient ID. If the user enters a patient ID that has existed in the database, when the user clicks [OK], the system will pop up the message for loading the ID data. User can preset auto ID or input ID manually in system preset.

Name, Gender and Age

Name: The user can directly enter patient name through the alphanumeric keyboard, and characters of A through Z, 0 through 9 and . are allowed; the user can also switch to Chinese input method to enter Chinese characters. Refer to the Appendix for the Chinese input method. Gender: The user can click to select Male or Female. DOB: The user can enter the birth date of a patient, and the system will automatically calculate the patient age and display it on the screen. The age unit is either Years, Months or Days. If the age is less than one year, the system will automatically
8-2

Patient Information

calculate age in months or days. The user can either enter the birth date manually, or click the icon following the entry box, and then the system will display the date

control as shown in the figure below:

Comment

The user can enter the comment information if necessary.

Move the cursor to select the corresponding item in the patient list of the iStation window, and continuously pressing theSetkey twice or clicking theInfo.button on the screen can view the patient information. Select a patient, click the [Begin Exam], then load the patient information as the current patient information.

8.2.2 Detailed patient information

Click on the Patient Info screen to open the detailed patient information screen. The detailed information consists of General and OB.

The general information contains: Height, Weight, BSA (automatically calculated by the system) and Formula, BP, HR, physician information, patient phone number and address.
8-3

Patient Information

The OB information contains: 1 LMP 2 EDD by LMP 3 GA by LMP 4 Exp. Ovular : Last Menstrual Period : Estimated Date of Delivery, calculated by LMP : Gestational Age, calculated by LMP : Expected date of Ovulation

5 EDD by Exp. Ovular : Estimated Date of Delivery, calculated by Exp. Ovular 6 GA by Exp. Ovular 7 Gestation 8 Gravida 9 Para 10 Ectopic 11 Aborta 12 Days of cycle : Gestational Age, calculated by Exp. Ovular

: number of embryo : times of pregnancy : times of delivery : times of ectopic gestation : times of abortion : days of Menstrual cycle

8-4

Patient Information

8.3

Importing Patient Information Worklist

After installing the DICOM software package and setting the worklist server, the user can click to import the patient information, as shown in the figure below:

The operation is described as follows: 1. 2. Determine the data source: select the worklist server. Set conditions of the patient to whom the worklist is imported: ID, patient name, DOB or exam date. 3. Click , and then the system will search the corresponding patient

information according to the set conditions. 4. 5. To change the conditions, click to reset the conditions.

In the patient worklist, select the desired patient to be imported, and click [OK] to
import the patient information to the ultrasound system.

8-5

9
9.1
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

Exam Modes

CAUTION: Once the exam mode is changed during a measurent, all

measurement calipers on the image will be cleared. The data of general measurements may be lost, but the data of application measurements are stored in the reports.

Instruction of Exam Modes

Adult ABD (Adult abdominal) Adult Cardiac GYN (Gynecology) OB1 (First trimester) OB2/3 (Second and third trimester) Fetal Cardiac Kidney Prostate THY (Thyroid) Breast Other SMP (Other small parts) Carotid Per Vein (Peripheral vein) Per Artery (Peripheral artery) Ped ABD (Pediatric abdominal) Ped Cardiac (Pediatric cardiac) User 1 User 2 User 3 User 4

This system can configure the following exam modes:

9-1

Exam Modes

9.2

Selecting Exam Modes

Connect a transducer to the system, and press theProbekey to open a dialog box as shown in the figure below. Roll the trackball to move the cursor to select exam modes corresponding to the transducer and press theSetkey to confirm.

9.3
screen.

Presetting Exam Modes

In the preset menu, select the [Exam Preset] item, and click it to enter the exam preset

Click the [Preset] button on of the transducer screen, and the user can also enter the exam preset screen. The exam preset screen consists of exam selection for transducers and parameter setup for exam modes, i.e., Exam Selection and Exam Config.

9-2

Exam Modes

9.3.1

Exam Selection

After the exam preset screen is entered, the dialog box generally displays the Exam Selection page, as shown in the figure below. This page is used to set applied exam modes for the specified transducer.

The operating method is described as follows: 1. Select a transducer: move the cursor onto the column and select the transducer model through the drop-down menu. 2. On the right side of the screen, the user can view the exam modes supported by the current transducer; on the left side, the user can view all the exam modes supported by the system, i.e., Exam Library. To delete a mode supported by the current transducer, select the mode first, and then click to delete it. To add ,

a mode for the current transducer, select the mode from the exam mode library on the left side, and click to add it to the Exam Selected column. Click

to add all different items between the exam library and exam selected to the Exam Selected column. 3. After the selected exam modes are set, the user can arrange the order of these exam modes. By means of the and buttons, the user can

adjust the order of these exam modes one by one. 4. To set some exam modes to default exam modes for the transducer, first select the exam modes, and then click 5. Clicking modified setup.
9-3

. can cancel the

can confirm the modified setup; clicking

Exam Modes

9.3.2 Exam Config

The Exam Config dialog box is shown as follows:

In the Exam Config screen, the user can configure parameters of measurements, comments, body marks and images for each exam mode.

9.3.3

User-defined exam modes

The user can define exam modes, through the Exam Config page in the Exam Preset dialog box. The procedures are described as follows: 1. 2. 3. 4. 5. 6. Select User 1, and then the background becomes light blue. Click Click Click Click to set measurement package for the user-defined mode. to set commonly-used comments for the user-defined mode. to set body mark type for the user-defined mode. to set image parameters for the user-defined mode.

The process of defining exam mode is complete.

9-4

10
WARNING:
diagnostic results.

Image Modes

The images displayed in this system are only reference for diagnosis. Mindray is not responsible for correctness of diagnostic results, while the physician, who performs the exam, is responsible for the correctness of

10.1

Categories of Image Modes

The system supports the following image modes: B mode; M mode; Color mode; Power/DirPower mode; PW mode

10-1

Image Modes

10.2
Key

Switching Between Image Modes

Selecting and Switching

B mode knob; pressing it can enter B mode; turning it can adjust B gain

M mode knob, press the key to enter the M mode, and rotate the key to adjust gain of M image.

PW mode knob, press the key to enter the PW mode, and rotate the key to adjust gain of PW image

Reserved.

Color mode knob; pressing it can enter Color mode; turning it can adjust gain.

Power mode knob; pressing it can enter Power mode; turning it can adjust gain.

Dual-split display key, Press the key to enter the Dual-split display mode.

Quad-split display key, Press the key to enter the Quad display mode.

Switching key; press it can cyclically switch image windows in the PW +B or M+B mode.

10-2

Image Modes

10.3

Image Adjustment

The image adjustment is performed through the image menus and control panels. The user can switch options on the menus through theSetkey and Back key, or keep the cursor on the menu item, and rotate the multi-functional knob to adjust parameters or options. The panel-adjusting items are adjusted through the buttons or sliders on the panels.

10.3.1 B mode
Change B image display
In the B mode, the user can change display depth, reverse (horizontally or vertically) an image, rotate an image, change view field of an image, or magnify an image.

Change display depth

Through theDepth/zoombutton on the main panel, the user can adjust the display depth when the Depth indicator lights on. The adjustable depth values vary depending upon transducer types.

Reverse/rotate an image
Left/Right reverse: through the [L/R Reverse] item in the B image menu can switch between Left and Right. Or clicking the image icon at the

bottom of an image can reverse the image horizontally. Up/Down reverse: through the [U/D Reverse] item in the B image menu can switch between Up and Down. Or clicking the image bottom of an image can reverse the image vertically. Rotation: through the [Rotation] item in the B image menu can cyclically select between rotation angles. The user can identify image orientation through the M mark on the screen: by default, the M mark is located in the upper left corner. icon at the

Change view field of an image

Scan Range: The scan range can be changed by adjusting scan angle. The scan range setup has four selections and they can be switched through the Scan Range item in the image menu. Steering scan:
10-3

Image Modes

The steering scan function is only valid for linear transducers, and the steering angle is adjusted through theB Steerlever on the main panel.

Optimizing B image
The change of image-optimizing parameters affects the image quality, and the user can adjust them as per actual needs.

iTouch
The iTouch key is used to optimize image parameters as per the current tissue characteristics, in order to obtain better image effect. The function is realized through theiTouchkey on the main panel.

Gain
To adjust the B image gain, turn theBknob on the main panel.

TGC
TGC (time gain compensation) control is used to adjust depth gain to optimize an image in different segments of the image. The system has 8-segment TGC sliders, and the user can adjust them as per needs. Move sliders to the right, gain increases, corresponding area image brightness increases; move sliders to the left, gain decreases, corresponding area image brightness decreases.

Focus number
To change focus number in the scan field, the user can switch between options of Focus Number in the image menu.

Focus position
To change the focus position, the user can adjust theFocuslever on the main panel.

Line density
It is used to change scan density. The higher the scan line density, the smaller the frame rate. The user can switch it through the Line Density item in the image menu.

MBP
MBP (that is Multi-beam Parallel Imaging) increases temporal resolution and real-time frame rate, while collecting useful information to re-build high quality images. The user can adjust it ON or OFF in the image menu.

Dynamic range
The dynamic range function is used to adjust contrast resolution of the image to compress or expand grey display range. The user can adjust numeric through the Dynamic Range in the image menu or image parameters field.

10-4

Image Modes

Colorize
User can open or close the colorize function through the colorize item in the image menu. In Colorize Map, user can select Colorize code. The position where the grey scale bar is displayed displays Colorize code. The user can also click the icon below the image to oen or close colorize function.

TSI (tissue specific imaging)

This function is used to select acoustic speed according to tissue characteristic, and this system can set four specific tissues, i.e., general, muscle, fluid and fat. The user can switch between selections.

Frame average
This function is used to superimpose and average adjacent B images, to remove image noise, making image details to be clearer. The user can perform this function through the Frame Average item in the image menu.

Smooth
This function is to reject image noise, making images to be smooth. The user can adjust it through the Smooth item in the image menu. The smaller the value, the lower the smooth; whereas the bigger the value, the higher the smooth.

Noise rejection
This function is to reject image noise, thus increasing signal-noise ratio. The user can adjust it through the Noise Reject in the image menu. The smaller the value the lower rejection; whereas the bigger the value the higher the rejection.

AGC
AGC refers to automatic gain control, used to increase acoustic shadow in bright area and dark area. The user can adjust automatic gain level through the AGC menu item. The smaller the value the smaller the AGC; whereas the bigger the value the bigger the AGC.

Edge enhancement
This function is used to increase image profile, in order to distinguish image boundary. The user can adjust it through Edge Enhance in the image menu. This function can be set to OFF if it is not used.

IP
IP refers to a combination of image processing parameters, including dynamic range, edge enhancement, smooth, frame average, AGC and noise rejection. This system can preset 8 groups of IP combinations, and the user can switch between groups of
10-5

Image Modes

combinations through theIPlever, and the IP combination number is displayed on the upper right side of the screen. The user can view it when the menu hides.

THI (tissue harmonic imaging)

The system provides the THI function, and the user can adjust theFreq/THIlever to switch to THI. In the THI condition, adjusting IP can generate the THI IP value, and the user can also preset THI IP in the image parameter preset.

Gray map
The system presets several gray maps, and each map is derived from combination of grey transform curve, grey rejection curve and correction. The user can select Map1 to Map8 through the Gray Map item in the image menu, and can preset Map in the image parameter preset.

Post process
Post processing is used to apply the gray correction to the image in order to obtain the image with optimum map The user can use the post processing submenu of the image menu to adjust the grey transform curve, grey rejection curve and correction. The post processing is valid for real time, frozen and Cine reviewed images. Gray Transform: 1. 2. Click [Curve], and the gray transform curve pops up; Move the cursor onto a node of the curve, and the cursor becomes cursor, and the user can see that the image changes with the adjustment; 3. Press theSetkey again, fix the node in the new position, and the cursor resumes to . Repeat the above process, the user can adjust the next node; pressing the Back key can cancel the adjustment, and the resumes the previous position. 4. 5. Press theSetkey on the Linear Transformitem, and the grey transform becomes a 45straight line; Clicking theOKkey can confirm the adjustment and exit the status; clicking the Cancelcan resume the previous curve and exit the status. The adjustment is shown in the following figures: ; press theSetkey, and roll the trackball to move the to adjust the grey transform

10-6

Image Modes

Gray Rejection: The gray rejection is to reject image signals less than certain grey scale. 1. 2. Click the [Rejection] item of the [Post Process] menu in the B image menu or M image menu, the gray rejection dialog box pops up; Move the cursor onto , and the cursor becomes see that the image changes with the adjustment; 3. 4. After adjustment, press theSetkey again, and the cursor resumes to ; or pressing the Back can cancel adjustment, the resumes the previous position. Pressing the Set key on OK can confirm the curve adjustment and exit the status, and the gray rejection dialog box disappears; or selectingCancelcan resume the previous curve and exit the status, and the gray rejection dialog box disappears. The adjustment is shown in the following figures: , and press theSetkey; roll the trackball to move the to adjust the gray rejection curve. The user can

correction: correction is used to correct the non-linear distortion of images. correction parameters are represented by 0, 1, 2, and 3, respectively representing coefficients of 1, 1.1, 1.2, and 1.3. The user can adjust [] item of the [Post Process] submenu in the B image menu or M image menu, and the correction parameters are displayed on this menu item.

10-7

Image Modes

10.3.2 M mode
Change M image Scan speed
This function is used to set the refreshing speed of M images. The user can adjust it through the Speed item in the M image menu. The smaller the value, the faster refreshing speed; whereas the bigger the value, the slower the refreshing speed.

Time mark
This function is used to turn on or off the display of the time mark on the M image. The user can set the Time Mark through the M image menu.

Full screen
The full screen function refers to the M image be displayed in full screen, and it is set through the Full Screen item of the M image menu. Turning on this function can only display the M image, while turning it off displays the M+B images.

Optimizing adjustment
The meaning and adjustment of most parameters of M images are similar to those of B images, so adjustment of Colorize, dynamic range, edge enhance, AGC, gray maps, IP, post processing will not be repeated here. Refer to relevant sections of B images. The following is to introduce the special parameters of M images.

Gain
Rotating theMknob on the main panel can adjust the M image gain.

Line Correlation
This function is used to process the scan lines of M images to reject noise, making the image details to be clearer. The user can adjust it through the Line Correlation item in the image menu. The smaller the value, the smaller the line correlation.

Smooth
This function is to obtain smooth transition of M images. The user can adjust it through the Smooth in the M image menu. The smaller the value, the smaller the smooth.

Image enhancement
Image enhancement is used to increase acuteness of M images, and it is adjusted through the Image Enhance item in the M image menu.

10-8

Image Modes

10.3.3 Color mode

The color flow mode is used to detect color flow information, and the color is designed to judge the direction and speed of blood flow. Generally the color above the color bar indicates the flow towards the transducer, while the color below the color bar indicates the flow away from the transducer; the brighter the color, the faster the flow speed; whereas the darker the color, the slower the flow speed.

Change image display format Baseline

Adjusting baseline to change the range of blood speed, the user can adjust the color bar baseline through the Baselinekey on the main panel.

Color reverse
Clicking [Reverse] in the image menu can switch between ON or OFF. When ON is set, the color bar is reversed.

ROI Color
Clicking the [ROI Color] item in the image menu can change the ROI color. There are up to 8 colors for selection.

B/C Wide
The maximum width is set to be the same as that of a B image. This function can be switched through ON and OFF in the menu.

B/C Sync
This function is used to synchronously display B image and Color image, and the window will be automatically switched to the dual windows (one for B image, the other for Color image) when the function is turned on. It is selected through the Color image menu.

Image Disp
This function is used to turn on or off the B image display outside the color ROI, and it is set through the Color image menu.

Optimizing adjustment Color gain

This function is used to adjust color gain, and can be adjusted through theColorkey on the main panel.

Color frequency
This function is adjusted through theDoppler Freqlever on the main panel.

Wall filter
This function is used to adjust the cut-off frequency of wall filter, and can be adjusted
10-9

Image Modes

through the Color Filterlever on the main panel.

PRF
The PRF value is used to adjust the speed range of the color flow, and can be adjusted through theScalelever on the main panel.

Steering angle
This function is used to adjust the scan angle of linear transducers, and can be adjusted through theColor Steerlever on the main panel.

Color map
The color map is a group of the color image map parameters, and can be switched through the image menu. The user can also click the switch between color maps. icon below the image to

Line density
This function is used to change scan density. The user can switch it through the Line Density item in the image menu.

MBP
MBP (that is Multi-beam Parallel Imaging) increases temporal resolution and real-time frame rate. The user can turn on or off the function through the MBP item in the image menu.

Packet size
The packet size is used to adjust the accuracy of blood flow. The parameter can be switched through the image menu.

Smooth
This function is to reject image noise, making images to be smooth. The user can adjust it through the Smooth item in the image menu. The smaller the value, the lower the smooth; whereas the bigger the value, the higher the smooth.

Persistence
The persistence is a parameter for temporal smooth. The user can adjust its levels through the image menu.

Contrast
The contrast refers to contrast of color maps. The user can adjust it through the image menu. The bigger the value the stronger the contrast; whereas the smaller the value the weaker the contrast.

Priority
This function is used to set levels of the flow display, and it is adjusted through the image menu.

10-10

Image Modes

Focus position
This function is used to adjust the color focus position relative to the B focus. The user can adjust it through the [Focus Position] item in the image menu. When its value is changed, the transmit focusing delay changes accordingly.

10.3.4 Power/DirPower mode

Power mode is used to image blood flow by displaying the density of red blood cells, as opposed to their velocity, in the form of different brightness, but it doesnt provide the directional information. However, the DirPower (Directional Power Doppler) mode can provide information of the flow velocity and direction. Most parameter adjustments of Power mode are consistent with those of the Color mode and the dynamic range adjustment is consistent with that of B mode. Refer to relevant section of the Color mode and B mode. The parameters are adjusted through the control panel or the Power image menu. The following is to introduce the special items of the Power mode.

Map (Power Map / DirPower Map)

The maps in the Power image menu are grouped into two categories: Power maps and Directional Power maps. The former four belong to Power maps, and the latter four belong to Directional Power maps. The Power maps provide information of flow speed; the Directional Power maps provide not only information of flow speed but also information of flow direction. The operator can switch among the maps through the "Map" item in the Power image menu to select the desired one.

LVRLow velocity rejection

The low velocity rejection function is to shield the information of some low velocity flow. The user can adjust the rejection levels through the [Low Vel. Reject] item in the Power image menu. The bigger the value the bigger the flow speed rejected; the user can turn off this function.

10-11

Image Modes

10.3.5 PW mode
PW mode (Pulsed Wave Doppler mode) scan produces a series of pulses used to study the motion of blood flow at a small region along a desired scan line. The X-axis of the graph represents time while the Y-axis represents Doppler frequency shift. The shift can be converted into velocity and flow if an appropriate angle between the beam and blood flow is known. The thickness of the spectral signal is indicative of laminar or turbulent flow.

Scan speed
The user can click the [Speed] item in the image menu to switch between different scan speed levels.

Colorize
Adjustment of PW Colorize is identical to that of B mode Colorize.

Reverse
Clicking the [Reverse] item in the menu can switch between ON and OFF options. When the option is set to ON, the frequency spectrum is reversed.

Size and angle of sample volume

Moving theSVlever on the main panel can adjust the width of the sample volume. Moving thePW Steerlever on the main panel can adjust the steering angle of SV. Rotating theAngleknob on the main panel can adjust the correction angle of SV.

Baseline
Moving theBaselinekey on the main panel can adjust the baseline.

Wall filter
The PW mode wall filter is to adjust the cut-off frequency of wall filter, and the user can adjust it through theFilterlever on the main panel.

PRF
The PRF value is to adjust the flow speed range, and the user can adjust it through the Scalelever on the main panel.

Color frequency
This function is adjusted through theDoppler Freqlever on the main panel.

Simul
When the [Simul] item in the PW image is set to ON, it indicates that the image in the B/Power mode is simultaneously scanned, i.g., the system enters the PWB (or Power) double real time mode. When it is set to OFF, it indicates that it is non double real time
10-12

Image Modes

mode.

Auto Trace
PW Auto Trace function is to set the maximum speed, average speed and maximum scattering value of tracing through the PW image menu. Set type of trace through [Auto Trace] submenu; The level change of [Threshold] is only valid for the maximum speed trace, used to change the trace coefficient. When [Trace Area] is set to ALL, the whole spectrum will be traced; when it is set to Top, the spectrum above the baseline will be traced; when it is set to Bottom, the spectrum below the baseline will be traced. The [Trace Smooth] item is to set the smooth of tracing.

Audio
The user can set the PW audio to ON or OFF through the PW menu.

Time mark
When a spectrum is viewed, the time mark facilitates to specify the time information of special points. The user can set the [Time Mark] item to ON or OFF through the PW menu.

Full Screen
The full screen function refers to the PW image be displayed in full screen. Turning on this function can only display the PW image, while turning it off displays the PW+B images.

10.3.6 Acoustic power

The acoustic power refers to the power of the ultrasound transmitted by the transducer. The acoustic power shall be selected according to practical situations and ALARA principle. Rotating theA.Powerknob can adjust the acoustic power. The acoustic power level is displayed right below the image (as well as MI/TI).

10.3.7 Image magnification

Press the key, the Zoom indicator lights on, and the system enters the

magnification status. Rotating the knob can adjust the magnification factor. In the Zoom status, rolling the trackball can move the amplified image so as to view the detail. Pressing it again or pressing theExitkey can exit the magnification status.
10-13

Image Modes

10.4

Image Parameter Preset

The user can enter the image parameter preset screen through the Image Preset item in the [Preset] menu or on the Exam Preset page.

The image preset is used to set image parameters for a specific transducer in a specific exam mode. The setting methods are similar although parameter items are different in each image mode. The following is to take B/THI image mode for the 3C5 transducer in adult abdominal exam mode as an example.

The Use 1 - All Probe field on left side of the screen displays the general parameter setup for all transducers in abdominal exam mode. The Use 1 - 3C5 field on the right side of the screen displays parameter setup for the 3C5 transducer in User1 exam mode. The operation of the image parameter setup is easy, and the user can click options or select in the drop-down menu. The following is to introduce the [Load Factory] function and [Record Current] function. [Load Factory]: Click [Load Factory], and the parameter setup in all pages will resume the factory setup. [Record Current]: Clicking [Record Current] can quickly store the currently-used parameter values for each parameter item in the image parameter preset, and the setup is valid for all pages of this dialogue box.

10-14

Image Modes

IP parameter preset: Click the [BIP] or [THI IP] button, and the corresponding IP combination preset can be entered, as shown in the figure below. The user can set the parameter values of each IP combination, and click [OK] to store the new setup.

Preset of gray map: Clicking [Gray Map] on the Image Preset screen can enter the preset of gray map, as shown in the figure below.

Refer to relevant B mode chapter for adjustment of post processing curves. The system can preset 8 post processing maps, which can be selected through the image menu. [Record Current]: Clicking [Record Current] can quickly store the currently-used parameter values for each parameter item in the image parameter preset, and the setup is valid for the current preset page.

10-15

11
reviewed.

Cine Review

After freezing, the system allows user to review and edit the images prior to freezing. This function is called as Cine review. The magnified images can also be reviewed after freezing, and the operating method is same. The user can change post processing effect, perform measurements, add comments and body marks on the images being The Cine review function of the system supports to be reviewed manually and automatically; the default setup is Manual Cine, but the user can switch between Auto Cine and Manual Cine.

CAUTION: 1.

Before a new patient is examined, press the Patient key to

clear the Cine memory, to avoid confusion of new and old patient images and misdiagnosis. 2. The Cine files stored in the hard disk contain patient information for reference, to avoid error and misdiagnosis.

11.1

Entering/Exiting Cine Review

Entering Cine Review: Press the Freeze key to freeze an image, and the Cine key indicator lights on, and then the system automatically enters the Manual Cine status. Exiting Cine Riview: Press the Freeze key again, the system will return to scanning image and exit cine review. Press Cine key or Exit key, the images are already in freezing but the system exit cine review.

11-1

Cine Review

11.2

Cine Review in the B/Color Mode

When the cine review in B or Color mode, roll the trackball, the Cines wiil be displayed in turn on the screen. Roll the trackball to the right, and the Cineloop sequences will be displayed in ascending order of frame number; whereas roll the trackbll to the left, and the Cineloop sequences will be displayed in descending order of frame number. The Cine process bar at the bottom of the screen (as shown in the figure below): the whole bar represents the total frame number, the numerics following the indicating bar represent the current frame No and the total frame No. The slider represents the currently reviewed frame number.

In the Manual Cine status, turning the multifunction knob can switch to Auto Cine. While Cineloop sequences are being reviewed, turning the multifunction knob can change the speed of Auto Cine. In the Auto Cine status, rolling the trackball can end the Auto Cine and enter the Manual Cine.

11.3

Cine Review in the PW/M Mode

When the cine review in PW or M mode, roll the trackball, the Cine will be displayed in turn on the screen. Roll the trackball to the left, the review process slider moves to the left, the images moves to right, and the earlier stored images are invoked; whereas move the trackball to the right, the review process slider moves to the right, and images move to the left, the recent stored images are invoked. The cine review process bar is displayed at the bottom of the screen (as shown in the figure below). The numerics following the indicating bar represent the current time and the total time in the M/PW mode.

To switch between Auto Cine and Manual Cine, the method is identical to that of the B/Color mode.

11.4

Linked Cine Review

The linked Cine review refers to simultaneous review of real-time images in the M+B, PW+B (or Color) mode. If the images in the two windows arent real time at the same time, the user can only review images in the current active window. Refer to description in sections 11.1 and 11.2 for cine review operations. However, in the linked cine review, B/Color images shall be simultaneously displayed with M/PW images.

11-2

Cine Review

11.5 Setting Region of Auto Review

For the Cine images reviewed, the user can set a region to review that be interested. 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. After the system enters the Cine review status, perform the following procedures to set the reviewed region. After the process of setting is complete, the new reviewed region is between the two triangle marks (as shown in the figure below):

Start Method 1: 1. 2. 3. 4. 1. 2. 3. 4.

End

Return images to the first image frame to be reviewed, and press the Set key to set the triangle mark for the start position. Press the Change key to switch to the end position. Return images to the last image frame to be reviewed, and press the Set key to set the end position. Rotate the multi-functional knob to enter the auto review. Manually return images to the first image to be reviewed, and press the Menu key to open the freeze menu, and click [Set Star t] to set the start position. Press theMenu key to close the freeze menu, and the system returns to the Cine review status. Manually return images to the last image to be reviewed, and press theMenuto open the freeze menu, and click the [Set End] to set the end position. Click [Review Loop Range] to enter the Auto Review status.

Method 2:

11.5.1 Relative preset

The user can preset the default review time in the system preset screen. Enter the preset screen, and open the [General] page. In the File Store field, the Cine Store item is located at the bottom, as shown in the figure below.

For Without ECG (s), the setting is second(s), referring to the duration from the moment of freezing counted down to the set time point. For With ECG (loop), the setting is cardiac cycles, which can only be selected through the drop-down menu. The cardiac cycles can be selected in the range of 1 through 3.

11-3

12

Measurements

WARNING:
1. Be sure to measure correct objects in effective area during measurements; otherwise it may cause misdiagnosis. 2. When a measurement of Doppler flow is performed, do not let the direction of a transducer be perpendicular to the direction of the flow; otherwise information of the flow cannot be displayed and misdiagnosis may occur.

CAUTION:
1. During the measurements, once the freezing status is unfrozen or the exam mode is changed, all the measure calipers will be cleared and the general measurement data will be lost (application measurement data are stored in reports). 2. During the measurements, When you turn off the system or press the Patientkey, all the data not saved will be lost.

12.1

Basic Operation

12.1.1 Entering the measurement status

Pressing the or key can enter the measurement status. The image

menus on the right side of the screen are respectively corresponded to the general measurement menu and application measurement menu. Press the same key again will exit measurements status. The measurement operation can be performed not only on a magnified image and Cine reviewed image, but also on a real-time image and frozen image.

12.1.2 Measurement result and Help information

The system displays and updates measurement results in the result display area. The Help information concerning measurement and calculation is displayed in the Help bar at the bottom of the screen.
12-1

Measurements

12.2

General Measurements

12.2.1 General measurements in the B mode

The measurements listed below can be performed in the B mode: Measurement item Depth Distance Angle Area Volume Cross line Parallel line Tracing length Ratio B histogram B profile Function The distance between a transducer surface and a point along the direction of the ultrasonic wave is measured. The distance between two points is measured. The angle between two intersected planes is measured. The area and perimeter of a closed region are measured. The volume of an object is measured (Ellipse-Volume, ED and 3D-Volume). The lengths of two line segments, which are perpendicular to each other, are measured. The distance between each pair of two lines among several parallel lines in the sequence is measured. The length of a curve is measured. To measure the lengths of any two lines and calculate the ratio To measure gray distribution of ultrasonic echo signals in a closed region To measure gray distribution of ultrasonic echo signals on a line

12-2

Measurements

12.2.2 General measurements in the M mode

The measurements listed below can be performed in the M mode: Measurement item Distance Time Slope Heart rate Function The vertical distance between two points is measured. The time interval between any two points is measured. The average speed (slope) is calculated by means of measuring the distance and time between two points. On an M HR image, the interval of n (n8) HR cycles is measured, and the number of HR per minute is calculated.

12.2.3 General measurements in the PW mode

The measurements listed below can be performed in the PW mode: Measurement item Time Heart rate Speed Acceleration Function The time interval between any two points is measured. The interval of n (n8) HR cycles is measured, and the number of HR per minute is calculated. On the PW-mode image, speed and pressure difference of a point on the Doppler spectrum waveform are measured. On the PW-mode image, speed and interval of two points are measured, and speed difference and acceleration are calculated. On blood flow waveform in the PW mode, the speeds of two peak points are measured, and RI (Resistance Index) and the ratio value are calculated. On the PW-mode image, the speed, difference and index of Doppler waveforms are obtained through tracing one or several Doppler waveforms. The range of auto trace is selected through [Spectrum Range].

Resistance index

Spectrum trace

12-3

Measurements

12.2.4 General measurements in the Color mode

The measurements listed below can be performed in the Color mode: Measurement item Depth Distance Angle Area Volume Cross line Parallel line Tracing length Ratio B histogram B profile Color speed Function The distance between a transducer surface and a point along the direction of the ultrasonic wave is measured. The distance between two points is measured. The angle between two intersected planes is measured. The area and perimeter of a closed region are measured. The volume of an object is measured (Ellipse-Volume, ED and 3D-Volume). The lengths of two line segments, which are perpendicular to each other, are measured. To measure the distance between each pair of two lines among several parallel lines in the sequence. To measure the length of a curve. To measure the lengths of any two lines and calculate the ratio To measure gray distribution of ultrasonic echo signals in a closed region To measure gray distribution of ultrasonic echo signals on a line On the Color-mode image, the speed of blood flow is measured.

12-4

Measurements

12.3

Application Measurements

12.3.1 Measurements in obstetrics

The measurements in obstetrics application are used for calculating fetal gestational age (GA) and estimated delivery date (EDD), for measuring and calculating fetal growth indexes, such as fetal weight, and by means of growth curve and Fetus Biophysical Profile the user can judge if the fetus grows normally.

Measurement item Fetus measurement items Fetus Doppler Calculation items Amniotic fluid index (AFI) Fetal weight (EFW) Fetal Biophysical Profile

Content Measure the parameters of fetal growth.(such as Gestational Sac Diameter, Crown Rump Length, Yolk Sac Size, Bi-Parietal Diameter, Occipital Frontal Diameter, fetal cephalic, etc) Umbilical Artery, middle cerebral artery, Uterine Artery, Fetal Aorta, etc GA and EFW, etc. Measuring amniotic fluid depth for calculating AFI Estimate fetal weight through the fetal growth parameters. After the fetus images are observed with scrutiny and fetus growth parameters are obtained through experiments or measurements, the fetus growth is evaluated, based on certain criteria, for the purpose of clinical reference.

12-5

Measurements

12.3.2 Measurements in cardiology

The measurement items include left ventricle function measurement and measurements of main artery and vein parameters. The measurement items are listed in the table below:

Measurement item Cardiac measurements

Content The measurement items include: left ventricle function RV left ventricular mass weight Right Ventricular End Diastolic Diameter heart rate ejection time The measurement items include: aorta blood flow of aorta blood flow of pulmonary artery blood flow of pulmonary vein mitral valve blood flow of mitral valve blood flow of tricuspid valve flow volume

Blood flow measurements

12-6

Measurements

12.3.3 Measurements in gynecology

The application measurement for gynecology is used for the uterus, ovary and dominant follicle.

Measurement item Uterus

Content The measurement items include: Uterus body Cervix Endometrial thickness Left ovary volume and right ovary volume

Ovary volume Dominant follicle measurement

Left dominant follicle and right dominant follicle (up to 8)

12.3.4 Measurements in small parts

The application measurement for small parts is used for small parts such as thyroid.

Measurement item Thyroid volume

Content Left and right thyroid volumes

12.3.5 Measurements in urology

The application measurement for urology is used for prostate volume, seminal vesicle, kidney volume, renal cortex thickness, adrenal gland, remnant volume, testicle volume.

Measurement item Prostate

Content Using rectum scanning method to measure prostate volume, and calculating prostate specific antigen based on the formula. Measuring sizes of left and right seminal vesicles Measuring volumes of left and right kidneys Measure length, width and thickness of adrenal gland. Measuring remnant urine volume after micturition, i.e. size of a bladder after micturition Measuring the volume of a testicle

Seminal vesicle Kidney Adrenal Gland Remnant Testicle

12-7

Measurements

12.3.6 Measurements in orthopedics

The application measurement for orthopedics is mainly used for hip joint measurement.

Measurement item HIP

Content Draw BL (baseline), ARL, and IL and calculate hip joint angle;
then estimate the type of dislocation based on age and angle force of the infant..

12.3.7 Measurements in peripheral vessels

The application measurement for peripheral vessels is used for carotid vessel, upper and lower limbs vessels. The PV measurement items are listed in the table below:

Measurement item Carotid vessels

Content The measurement items include: Common carotid artery Internal carotid artery External carotid artery Vertebral artery Upper and lower limbs vessels

Upper and lower limbs vessels Vessel parameters

Flow speed Length stenotic ratio Area stenotic ratio Eastimated flow volume through vessel diameter Eastimated flow volume through vessel area

12-8

13

Comments

Comments are often required to add on ultrasonic images during diagnosis, thus enhancing readability of the images. The comments can be added on frozen images, as well as reviewed images and magnified images. The types of comments include: texts and indicating arrows.

WARNING:

Ensure that the entered comments are correct. Incorrect comments may cause misdiagnosis!

13.1
Press

Entering/Exiting Comments
key to enter the comment status, and the cursor turns to |.

Pressing theCommentkey again or any other operating mode key can exit the comment status.

13.2

Comment Menu

In the comment status, pressing theMenukey can show or hide the comment menu. Through the menu, the user can change the font size and arrow size of comments, or enter the dialog box of comment preset. The menu is shown in the figure below:

In addition, clicking the and arrow size of comments.

icon in shortcut tools bar can also change the font size

13-1

Comments

13.3

Adding Comments

13.3.1 Typing characters

After the system enters comment status, the procedures of typing characters through the keyboard are shown as follows: 1. Localize comments Roll the trackball or press the ,, orkey to move the cursor to the desired position. 2. Type characters

Enter the comments directly through the keyboard; To enter a character on the upper characters of a key, press theShiftkey and the corresponding key at the same time, and the entry method is the same as that of the PC keyboard;

3. Line feed In the edit status of comments (characters are green), press theEnterkey, the cursor changes to the next line, and its position is lined up with the first line. 4. In the edit status of comments, move the trackball or press theSetkeykey to confirm the added characters, and the color of the characters turns to yellow.

13-2

Comments

13.3.2 Comment library

1. In the comment status, place the cursor in the desired position in the image. 2. Turn the multifunction knob mode one by one. 3. Press theChangekey to display the comment library dialog box, as shown in the figure below: to display the general comment texts of the exam

4. Search the desired comment text Select the category first and click its tab to enter the page. Move the scroll bar on the right side to search the desired comment text. 5. Select comment text Move the cursor on the desired comment text and press theSetkey, and the system automatically adds the selected text to the specified position and closes the dialog box. At this time the added comment text is in the edit status, so the user can edit this comment text. 6. Press theSetkey or move the trackball to confirm the comment text. If there is no desired comment text in the comment library and it needs to exit the library, place the cursor on the [Close] button of the dialog box and press the Set key to close the dialog box.

13-3

Comments

13.3.3 Adding indicating arrows

The indicating arrow is used in the place where needs to add the comment or to highlight. 1. In the comment status, press the key, and an indicating arrow appears in

the default position in the image. The user can move the arrow and adjust its direction, or delete it. 2. 3. Localize an arrow: roll the trackball to move an arrow to the desired place. Adjust the direction of an arrow

Turn the multifunction knob increments of 15 for each level. 4.

to adjust the direction of an arrow in the

The size of an indicating arrow is adjusted through the comment menu or shortcut tools bar.

5. 6.

Pressing theSetkey can confirm the added arrow, which turns to yellow. Repeat the above procedures to add more indicating arrows.

13-4

Comments

13.4
1.

Moving Comments
In the comment status, roll the trackball to move the cursor onto the comment that needs to be moved. Press theSetkey to select it, and at this time a highlighted frame appears around the comment.

2. 3.

Roll the trackball to move the comment to the new position. Press the Set key to anchor the comment in the new position, and the comment-moving operation is complete.

13.5

Modifying Comments

13.5.1 Modify characters

1. Roll the trackball to move the cursor on the comment that needs to be modified, and press theSetkey to select it. 2. 3. Press theSetkey again to enter the edit status. Use theorkey to move the cursor to a place where needs to insert characters, and type characters or select the new comment text from the comment library; pressing the Del key can delete the comment character or text on the right side of the cursor, and pressing theBackspacekey can delete the comment character or text on the left side of the cursor. 4. Press theSetkey to confirm the modification and to exit the edit status, and the color of the comments turns to yellow.

13.5.2 Modify indicating arrows

1. Roll the trackball to move the cursor on the arrow that needs to be modified. The cursor turns to , and press the set key. The color of the current arrow turns to

green, and there is green frame around the arrow, indicating the arrow can be edited. Moving the cursor can modify the arrow position. 2. 3. Turn the multifunction knob to modify the arrow direction. Press thesetkey to complete the modifying operation.

13-5

Comments

13.6

Deleting Comments

13.6.1 Delete characters

1. 2. 3. Roll the trackball to a position where needs to delete comment characters. Press thesetkey to select the character to delete. Press the Del key or Backspace key to complete the deleting operation, and the cursor turns to the comment cursor.

13.6.2 Delete arrows

1. Press theChangekey to select the newly added arrow, enabling it to become active arrow. Press theChangekey to repeatedly select the newly added arrows in reverse order, until the desired arrow is selected. Or move the cursor until it turns to targeted arrow. 2. Press theDelkey orBackspacekey to delete the selected arrow. , and press thesetkey to select the

NOTE: repeatedly pressing theBackkey can delete the newly added arrows in reverse order.

13.6.3 Delete all comments and arrows

In the comment status, that is, the cursor is in the | status but no comment is edited, pressing the Back key can delete the previous comment; pressing the Clear key can clear all the comment characters, texts and arrows on the display.

NOTE: When no object is selected, pressing the Clear key would clear all comments
and all measurements calipers.

13-6

Comments

13.7

Comment Preset

The user can use comment preset function to preset the initial font size, commonly-used comments for each exam mode, and user-defined comments.

13.7.1 Preset usual comments

The user can preset the usual comments as required, and the preset comments will appear in the Usual Comment page in the first page of the comment library. The preset operation is performed according to the following procedures: 1. Enter the comment preset screen, and the system enters the dialog box as shown in the figure below.

2.

Select the usual comment texts in the available items on the left side, and click to add them to the column on the right side. Continuously clicking the

comment items can select multiple comment texts to be added, and once a comment text is selected its background becomes blue. Clicking theSetkey on the selected comment text can cancel the selection. To add all comment texts on the left side to the column on the right side, directly click 3. .

To select different categories of comment text libraries, the user can perform the selection through the drop-down menu on the right side of Comment Library as shown in .

4.

For the comment texts in the Selected Items column on the right side, the user can adjust their positions through the
13-7

or

button.

Comments

5.

To delete the comment texts in the Selected Items column, select the item to delete and then click . To delete all items, click .

13.7.2 User-defined comments

The system allows the user to define comments to complement the comment text library and facilitate the use of comments. The operation is performed according to the following procedures: 1. Click in the comment preset dialog box to enter the user-defined comment

dialog box, as shown in the figure below.

2. 3.

Enter the comments to be added in the edit box. When the button is highlighted indicating the addition operation can be button to add the user-defined comment.

performed, click the 4.

To modify a comment added, move the cursor to select the comment. The selected comment appears in the edit box as shown in the figure above. Now the comment can be edited. After the edit is complete, if click the button the modified comment will be button, the

added into the comment library as a new comment; if click the modified comment will overwrite the previous comment.

13-8

Comments

5.

The user-defined comments will appear on the User-Def page in the comment library dialog box, as shown in the figure below.

Import or export the user-defined comments

The user can add user-defined comments through the Load button, or save them through the Export button. The file format of comments supported by the system is *.TXT.

13-9

14
14.1
mode.

Body Marks

The body marks are used for indicating the exam position of patient and probing position and orientation of a transducer, served as additional explanation for an image.

Entering/Exiting Body Mark Mode

key to enter the body mark selection

To enter the body mark mode, press the

To exit the body mark mode: In the body mark mode, press Body Mark again or the Exit key to confirm the current operation and exit the body mark mode.

14.2

Categories of Body Marks

The body marks are grouped into different categories: Abdomen, OB/GYN, Cardiology, Small Part, Blood Vessel, Urology, and Orthopedics. Each category consists of multiple body marks, and the user can select body marks or preset them in the exam modes as required.

14-1

Body Marks

14.3

Body Mark Menu

In the body mark mode, pressing the Menu key can open or hide the body mark menu. Through the body mark menu the user can open each category of the body marks or set the body mark function. The body mark menu is shown in the figure below:

The body mark setups are explained as follows: Current body mark The current body mark has two statuses, i.e., 1st and 2nd, and the 1st status is default. To add two body marks on an image at the same time, the user needs to set the Current BM to 2nd; otherwise the user cannot add the second body mark on the image. Display The user can display or hide the added body marks on the image.

14-2

Body Marks

14.4

Adding Body Marks

The system allows the user to add a body mark to an image, or to add two body marks to one image window. To add two body marks to one image window, first set the current body mark status to 2nd through the body mark menu. Refer to Body Mark Menu section for details. The operation will be described by the following procedures of adding one body mark to an image. 1. Select a body mark: in the body mark mode, move the cursor on the desired body mark, and the body mark becomes bright and with its frame highlighted (as shown in the figure below). Click or , or turn the multifunction knob, and the

user can look for the body marks of one category in different pages. When there is only one page, the user cannot turn pages. Pressing thechangekey can switch between different categories.

2. 3.

Confirm a body mark: press theSetkey to confirm the body mark added. Adjust the position and orientation of the transducer symbol: roll the trackball to place the transducer symbol in the correct position; turn the multifunction knob to adjust the orientation.

4.

Press the Set key to confirm the position and orientation of the transducer symbol and exit the body mark mode at the same time.

14-3

Body Marks

14.5
1.

Moving Body Marks

Roll the trackball to move the cursor onto an added body mark, and the cursor becomes , indicating the user can select this body mark.

The user can move the added body marks to any desired position on the image.

2.

Click theSetkey to select the body mark, and a frame appears around the body mark.

3.

Move the cursor to the desired position, and the body mark moves along with the cursor.

4.

Click theSetkey to confirm the new position, and the operation of moving the body mark is complete.

NOTE:
In B+B mode, bodymarks cannot be moved between image windows.

14.6
1.

Deleting Body Marks

Click theSetkey to select a body mark to delete, and press theClearkey to delete the selected body mark.

To delete an added body mark in the image window, perform the procedures as follows:

NOTE: In the body mark mode, if no object is selected, pressing the Clear key will clear all comments and general measurements. 2. In the body mark mode, pressing theBackkey can delete the added body marks one by one. 3. In the body mark selection status, if the user doesnt add any body mark, pressing theBody Markkey can exit the body mark mode.

14-4

Body Marks

14.7

Body Mark Preset

In order to adapt operation habits and clinical practice needs of different users, the system supports the preset function for body marks. This function is to preset the relevant parameters of body marks, preset body marks in each exam mode, and define body marks.

Preset position of body mark

The user can enter the General page in the System Preset screen through the preset menu, to modify the setup in the Body Mark and Comment field (as shown in the figure below). The user can set the position where a body mark appears on the image.

Preset desired body marks for an exam mode

1. Select the Body Mark Preset item in the preset menu or exam mode setup screen and enter the body mark preset dialog box (as shown in the figure below).

2.

Select the exam mode that you will preset the body mark, and click the drop-down menu to select the exam mode.

3.

Click to select the desired body mark on the Available Items. If the desired body mark is not found, open the Anatomic App. drop-down menu, to select other anatomical regions for corresponding body mark sets, and to search the desired body mark.
14-5

Body Marks

4.

Select the desired body mark, and click right side.

to add it to the column on the

5.

The user can arrange the order of the selected body marks in the column on the right side, through the Up or Down button.

Define body marks

If there is no body mark desired in the library, the user can define the body marks. In the body mark preset dialog box above, click box (as shown in the figure below). The user can edit, delete or export the user-defined body marks, or add body marks through drawing or importing. The method of importing and exporting is similar to that in the file system. The file format is *.BIN. The following is only to introduce the manual edit of body marks. to enter the user-defined dialog

14-6

Body Marks

The procedures of adding user-defined body marks are described as follows: 2. Click the Add button on the screen to enter the creation selection screen of body marksand the user can select to copy an existing body mark or draw a new body mark.

3.

Click [Copy] or [Add] button. The drawing screen is shown as follows:

14-7

Body Marks

4.

The drawing tools are described as follows:

Brush Up/down reverse Zoom in Rotate Eraser Left/right reverse Zoom out Drag

5.

The user can select

on the screen, to adjust position of the transducer

indicator on the body mark and rotate the multi-functional knob to change direction of the indicator. 6. After the drawing of a body mark is complete, click [OK] to save it and exit the user-defined body mark status.

14-8

15
15.1

Patient File Management

Image File Formats

Screen file (BMP) Single-frame file format, used to save the current screen, non-compressed format; Screen file (JPG) Single-frame file format, used to save the current screen, compressed format, compression ratio presettable; Single-frame image file (FRM) System-defined single-frame static file format, non-compressed format, used to edit measurements and comments;

The system supports the following image file formats:

Multi-medium file (AVI) Multi-frame file format, general Cine file format;

Cine file (CIN) System-defined multi-frame file format; the user can perform manual or auto Cine review, and perform measurements or add comments for the reviewed images.

DICOM file (DCM) DICOM standard files format, single-frame or multi-frame format, used to record patient information and images; the user can only open DCM files to view rather than to edit, which is identical to JPG format.

The shortcut storage format is set in the preset menu. Open the [General] page in the [System Preset] dialog box, and the file system setup area appears in the lower left corner (as shown in the figure below).

The user can set the storage format of static image and dynamic image and length of
15-1

Patient File Management

Cine files, and set the compression rate of JPEG image files.

NOTE: The compression of JPEG may result in image distortion.

15.2

Storing Image Files

During the process of examining a patient, the user can directly store the exam images to the patient database for image review. To quickly store images in the unfrozen status, the method is described as follows: Pressing the key can store the current single-frame image file in the default file

directory in the static image format (BMP, JPEG or FRM), and the file is stored in the default filename. After freezing, pressing the key can store the current image file in the default

directory in the dynamic image format (CIN or AVI), and the file is stored in the default filename. To store a file by manually naming the file, the method is described as follows: Press the Freeze key to freeze the image, and press theMenukey to open the menu, and select the [Image Data Save] item to open the storage dialog box, as shown in the figure below:

The user can change storage path, set storage format and name the file to store the image file.

15-2

Patient File Management

15.3

Image Review and Analysis

During the process of examining, the user can review and analyze the stored images concerning the current patient. Freeze and store an image, and then press theReviewkey; the image review window will appear in active window field. Move the cursor or use the toolbar (as shown in the figure below), and the user can select images.

: to the previous patient; : to delete the selected image;

: to the next patient;

: to hide the thumbnails and enter the image analysis. After entering the image analysis, measure and comment operations can be performed on the system defined image format such as FRM and CIN.

15.4

iVision

This function is designed to demonstrate the acquired images. The images files are played one by one as per the sequence of filenames. The user can enter the iVision dialog box through the [iVision] item in the [Other] menu, as shown in the figure below. The user can set the file path and demonstration interval.

The image demonstration can be played automatically. The images are played one by one as the set interval, and the images in the set filefolder can be played cyclically.

To exit iVision, the procedure is shown as follows: During the iVision, the user can press theExitkey to exit the iVision status.

15-3

Patient File Management

15.5

Search Patient
In the Patient Info screen to open iStation

Press theiStationkey or click screen, as shown in the figure below:

To inquire patient information, the procedures are described as follow: 1 Confirm data source: select the database position, such as internal hard disk. 2 Set the filtering conditions: ID, patient name, exam date (clicking quickly set the date as Today). 3 Click conditions. 4 To change the inquired conditions, click to reset the conditions. , and the system will start to search patient data according to the set can

15-4

Patient File Management

15.6

iStation

The user can press the iStationkey or Search button to enter the iStation (as shown in the figure below). And the user can manage the patient data (including images and reports) through the buttons on the right side of the screen.

The user can perform operations of Info, Select All, Delete, Export for patients items. The images and reports of the selected patient items are shown below the patient list, and the user can perform operations of Select All, Save As, and Delete. The operation buttons for patient data are located on the right side of the patient list, and their functions are described as follows: Info : to view patient basic information.

Select All : to select all patient data. Delete Export : to delete the selected patient data. : to export the selected patient data to other memory location.

The operation buttons for images and reports are located on the lower right side of the screen, and their functions are described as follows: Select All : to select all images or reports in the list. Save As Delete : to save the selected data to another place. : to delete the selected images or reports.
15-5

Patient File Management

15.7
disks.

Disk Management

The disk management function is designed to manage the directories and files saved in

The user can enter the File Manager dialog box through the [File Manager] item in the [Other] menu, as shown in the figure below:

15.7.1 Directory management

The directory management function is designed to create, rename, copy (cant be overwrited) or delete a directory.

To create a directory:
1. Select a drive to create the directory in the drop-down list box, and then select directory position for creating the directory. 2. Move the cursor onto theCreatebutton in the dialog box, and press theSet key. The directory-creating dialog box pops up. 3. Enter the directory name in the dialog box, and clickOKto close the dialog box, and the created directory is added in the directory list box. Or click theCancel button, and the operation of creating the directory is cancelled.

To rename a directory:
1. 2. 3. 4. Select the drive of the selected directory in the drive list box. Select the directory to be renamed in the directory list. ClickRename, and the Rename dialog box pops up. Enter the new name for the directory, and click [OK] to close the dialog box, and the name of the directory is updated in the directory list box. Or click the Cancel button to cancel the operation of renaming the directory.

15-6

Patient File Management

To delete a directory:
1. 2. 3. 4. Select the drive of the directory in the drive list box. Select the directory to be deleted in the directory list. Click theDeletebutton, and the directory-deleting dialog box pops up. Click theOKbutton to close the dialog box, and the directory is deleted from the directory list box. Or click the Cancel button to cancel the operation of deleting the directory.

15.7.2 File management

The file management function is designed to rename, delete or copy files, or delete all files in the current directory.

To rename a file:
1. 2. Select the drive and directory of the file to be renamed. Select the file to be renamed in the file list, and click the Rename button, and the file-renaming dialog box pops up. 3. Enter the new name for the file in the dialog box, and click theOKbutton to confirm the new name, or click theCancelbutton to cancel this operation.

To delete a file:
1. 2. Select the drive and directory of the file to be deleted. Select the file to be deleted in the file list, and click theDeletebutton, and the file-deleting dialog box pops up. 3. Click the OK button in the dialog box to confirm the deletion, or click the Cancel button to cancel this operation.

To copy or paste a file:

1. 2. select the file to be copied, and move the cursor onto theCopybutton to confirm. Select and enter the directory of the file to be copied, and move the cursor onto the [Paste] button, and press theSetkey to start the file coping operation. After the coping is complete, the copied file appears in the directory. 3. If there is a file with the same filename existing in the directory, the system will pop up a dialog box to prompt The file has existed, are you sure to overwrite it? The user can select to click OK or Cancel to confirm if the file is overwritten.

15-7

Patient File Management

15.7.3 CD file management

The system supports writing data in CD and reading data from CD. Click the [Burn] button on the [File Manager] screen to enter the CD backup operation, and the system pops up the dialog box as follows:

To back up data, the procedures are described as follows: 1. Put a rewritable CD in the CD-RW drive. NOTE: if you want to rewrite a CD which has data in it, please erase the data first and then rewrite it. To erase a CD, you can start the erasing operation through the [Erase] button on the backup screen. 2. Select a drive: select a drive in the drop-down list and double-click it. 3. Select the file folder or directory on the left side of the screen, click to add it the box where the files to be backed up are listed on the right side of the screen. To cancel the selected file, click after the file is selected. To cancel all selected files, click . Note: when the directory is more than 6 levels, the files cannot be backed up. 4. After the files are selected, the user can see the CD space occupied, free space, and total space. The total capacity of the selected files cannot exceed the CD capacity. 5. Click the [Burn] button, and the backup operation begins. 6. After the backup is complete, the screen will display information of writing successfully, and the CD automatically ejects out.

NOTE: During backup process, if a CD is forcibly taken out or the user performs other operations, the backup may fail or the system may malfunction.

15-8

16

Preset

The preset function is designed to set the configuration parameters of running environment, statuses and exam modes for the system while it is initialized. The preset values are stored in the internal memory of the system, so they cannot be lost at power-off, thus ensuring the system can run as expected each time when it is started.

CAUTION: After the preset data are changed, be sure to save the new preset
data. Refer to the method described in this Chapter. The manufacturer is not responsible for the loss of the preset data.

16.1

Entering/Exiting Preset

To enter the preset mode: Press the F10 key on the keyboard can open the preset menu quickly. Move the cursor onto the menu title (image menu, ECG menu or Freeze menu), and the system will automatically pop up the menu-switching items.Select the [Other] item, and then select the [Preset] item to enter the preset menu, as shown in the figure below:

To exit the preset mode: Click the [Return] item, and the system will exit the preset mode and run as per the modified parameters.

16-1

Preset

16.2

System Preset

The system preset contains several tab sheets, i.e., Local, General, System, Meas Param, Biopsy, Other and Sys Info. To confirm the modified parameters, click [Ok]. To cancel the modified parameters, click [Cancel]. Clicking the [Load Factory] button can restore the current page to the factory setups. The content of each page will be described as follows.

Local

The Local page is to preset hospital name, language, time zone, and time format. For the hospital name, the user needs to enter relevant information; for others, the user can select through options or drop-down menus.

General

The General page is divided into severral areas, i.e., Patient Information, File Access, System Dormancy, and Bodymark and Comment.

System

The System page is used for ECG-relevant setups and format setups of image display information.

Meas param

The measurement parameter page is used for setup of measurement unit, general measurements, calculation, volume and reports.

Biopsy

The Biopsy screen is used for default bracket setups and type setups of biopsy guide lines.

Other

The Other screen is to preset the default setups of peripheral devices (such as printer, VCR) and some setups of main panel such as key volume, lightness and trackball flexibility. Additionally the screen can be used to open the user-defined dialog box to set the blank keys on the minor panel and some F functional keys on the keyboard. Click the button to enter the dialog box shown in the figure below,

and set the reserved keys on the keyboard as shortcut keys. The method for setting the user-defined keys is described as follows: 1. Click Key Function to select which key the user wants to set user-defined function; 2. Move the cursor to the Category column to select the function category for the shortcut keys to be set (such as VCR, output, measurement, image);
16-2

Preset

3. 4.

Select the specific functions of the set category; Click [OK] to confirm the newly-defined setup, or click [Cancel] to cancel the newly-defined setup.

System Infomation

The Sys Info screen contains the version information of system software and other modules. The user cannot edit the information, but can only view it. The information varies with the system configuration and version, so it depends on the system purchased.

16.3

Exam Mode Preset

Refer to 9.3 Presetting Exam Modes .

16.4

Image Parameter Preset

Refer to 10.4 Image Parameter Preset.

16.5

Comment Preset

Refer to 13.7 Comment Preset.

16.6

Body Mark Preset

Refer to 14.7 Body Mark Preset.

16-3

Preset

16.7

Measurement Preset

Refer to Measurement Preset in the [Advanced Volume] of the operation manual.

16.8

Preset Data

Open the Preset Data submenu in the preset menu, and the user can select the [Save], [Load] or [Default]. Thus the user can save new preset data, load existing preset data or restore the factory setups.

16.8.1 Save preset data

This function is used to write all preset data by the user to a disk. The format of the data file is DTA. The procedures are described as follows: 1. Move the cursor onto the [Save] item and press theSetkey. The screen pops up the dialog box of saving files. 2. Select the driver, change the path and enter the filename. 3. ClickOK, and the dialog box closes. The system automatically saves the preset data to the specified file.

16.8.2 Load preset data

This function is used to load the existing preset data to the preset data memory of the system, and the system resets and runs as per the changed preset data. The procedures are described as follows: 1. 2. 3. Move the cursor onto the [Load] item and press theSetkey. The screen pops up the dialog box of opening files. Select the preset data file and open it. After the preset data file is opened, the system exits the file status. The system resets and organizes the image display as per the changed preset data.

16.8.3 Load factory

Move the cursor onto the [Default] item and press the Set key. The screen pops up the dialog box. Click theOKbutton, and the system will restore the factory setups. Click theCancelbutton, and the system will cancel the restoration of the factory setups.

16.9

Maintenance

The [Maintenance] item is designed for the user to update the system software or other special functions. If the user requires these functions, please contact Mindray representatives.

16-4

17
17.1

Biopsy Guide

Entering or Exiting Biopsy Menu

Move the cursor onto the menu title and the expanded list appears; select the [Biopsy] item from the list to open the biopsy menu, as shown in the figure below.

Press theExitkey or switch to another menu, and the system exits the biopsy menu.

WARNING: Do not freeze an image while performing biopsy procedure.

17.2

Displaying Biopsy Guide Lines

1 Select biopsy bracket To display biopsy guide lines, first specify the model of the biopsy bracket used with the current transducer. Select the model of the biopsy bracket through the item of the [Bracket]. 2 Display or hide the guide line To display the guide line of the current bracket, press theSetkey on [Display] to adjust the status to On. To hide the guide line, adjust the status to Off. 3 Select linetype Roll the trackball to move the cursor on [Linetype] , and click theSet or Back key to switch among linetypes of biopsy guide lines, i.e., Large, Medium, or Small.

17-1

Biopsy Guide

17.3

Verifying the Biopsy Guide line

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

NOTE:

If the B-mode image isnt displayed in the real-time status, you cannot verify the guide line.

Click [Verify] to open the Verify menu.

Adjust position Through the [Position] item in the Verify menu, the user can move the guide line horizontally. Move the cursor on [Position], and press theSetkey to increase the value or press theBackkey to decrease the value.

Adjust angle Through the [Angle] item, the user can adjust the angle of the guide line. The method is identical to that of adjusting Position.

Save verified settings After the position and angle of the guide line are adjusted, click [Save], and the system will save the current data of the guide line. When the system is restarted next time, the position and angle of the guide line are those verified.

Restore the factory default settings Click [Load Default], the position and angle of the guide line will restore the factory default settings.

Exit the Verify status Click [Exit], and the system will exit the verification status of the guide line.
17-2

18
the image is frozen.

ECG

The system can be configured with the optional ECG module. In that case, the ECG signals can be displayed on the image in real time. This ECG module only provides physiological signals for reference rather than for monitoring. Operaters shall take care. The ECG signal is displayed on the image, and can be reviewed with the image after

WARNING:
. To avoid electric shock, the following checks shall be performed prior to an operation: The ECG electrode shall not be abnormal (abnormalities refer to damage or crack of the electrode and cable); The ECG electrode shall be correctly connected; The user should use the ECG leadwire provided with the ECG module. Otherwise it may result in electric shock. 2. Only after the ECG cable is connected to the system, can the ECG electrode be placed on the patients body. Otherwise, the patient may be subject to electric shock. 3. Dont place the ECG electrodes directly to contact the patients heart; otherwise it may lead to stop of the patients heartbeat. 4. When the voltage applied on the body surface of the patient exceeds 15V, be sure to remove the ECG electrode from the patient, in order to prevent electric shock. 5. Before using high frequency electric surgical unit, high frequency therapeutic equipment or defibrillator, be sure to remove the ECG electrode from the patient, in order to prevent electric shock. 6. Conductive parts of electrodes and associated connectors for ECG should not contact other conductive parts including earth.

18-1

ECG

18.1
(1)

ECG Connection
Turn off the power supply of the system, and connect the ECG cable to the corresponding interface on the ECG module;

The ECG connection shall be performed in the following procedure:

(2) (3)

Turn on the power supply of the system; Place the ECG electrode on the patients body (as shown in the following figure);

Right

Left

Right

Left

Red

Yellow

White RA

LA Black

II N
Black

III F
Green

II RL LL
Green

III

Red

IEC standard

AHA standard

(4)

Press the

ECG key on the minor panel; after the ECG menu is

displayed, select the ECG Display as On. Now the ECG signals can be displayed.

18.2

Displaying ECG Signal

key on the minor panel, or select ECG

To display ECG signal, press the

through the menu title, and enter the ECG menu and set the Display to On.

18-2

19
NOTE: 1.
2.

VCR

VCR is used to record and replay images during the ultrasound exams. The memory medium of the VCR recorder is cassette.

Strictly observe the procedures described here to perform the recording and replaying operations of VCR; otherwise it may result in data loss or system malfunction. The video system (PAL or NTSC) shall be consistent with the recording system of the device.

3.

The recording may not be successful due to accidents, so regarding important data, please check if the images are successfully recorded while recording is complete. Mindray is not responsible for data loss.

19-1

VCR

19.1

Record

To record using a VCR recorder, please perform the operations as per the following procedures: 1. Connect the VCR recorder to the ultrasound system and put a cassette in the recorder. 2. Preset the VCR recorder in the peripheral devices screen: open the other preset page in the system preset dialog box; as shown in the figure below, the user can select VCR in the recorder type drop-down menu in the peripheral device preset field.

NOTE: the preset Baud rate shall be identical to that of the VCR recorder. We recommend setting the value of Bound Rate as 9600. 3. 4. Start the ultrasound exam and acquire images. Press the key on the minor panel to enter the record status for recording

images and sound. 5. 6. Press theRecordkey again to temporarily stop recording. Repeat the steps 4 and 5 to record multiple segments of images.

NOTE: After the cassette is recorded data and taken out, if the user want to insert it to go on recording, please first search the blank position and then start recording. Otherwise the subsequent recording will overwrite the existing data. 7. After the exam is complete, stop the VCR recording, and take out the cassette.

19-2

VCR

19.2

Replay

To replay the recorded images using VCR, please perform the operations as per the following procedures: 1. 2. 3. Connect the VCR recorder to the system and put the cassette in the recorder. Check preset: recorder type is set to VCR. Press the F9 key on the keyboard to enter the VCR replay status, and open the replay menu as follows:

Some menu items are to be introduced as follows: [Viss]: segment index, set for searching between segments; [Viss Mark]: to insert the segment mark in the current image position; [Search/Counter]: to search and set the VCR counter; [Search Blank]: to search a cassette to find the next blank position; [Eject]: to stop the VCR replay (but not to exit the VCR replay status), to eject the cassette.

4.

Click [Play/Pause]: to play the recorded images; click it again to temporarily stop playing.

5.

Press the F9 key again or click the [exit] item on the menu to exit the VCR replay status.

19-3

20
20.1

System Maintenance

The system maintenance shall be completed by users and Mindray service engineers, but the users will take all responsibilities for the maintenance and operation after the system is purchased.

WARNING:

Only the professional engineers can perform the maintenance not specified in this manual. However, you can contact your Mindray service representative.

Daily Maintenance

The user shall conduct the daily maintenance.

20.1.1 Cleaning the system WARNING: Before cleaning the system, be sure to turn off the power and
disconnect the power cable from the outlet. If you clean the system while the power is On, it may result in electric shock. 1. Cleaning the transducer Please refer to the operation manual of the corresponding transducer to perform cleaning, disinfection and sterilization. 2. Cleaning the transducer socket a Use soft dry cloth to erase the stains of the socket. b If it is difficult to clean the stains thoroughly, use soft cloth dipped with mild detergent, and then make it air-dried. 3. Cleaning the monitor Use the soft cloth dipped with glass detergent to erase the monitor, and then make it air-dried.

NOTE: Do not use hydrocarbon glass cleaner or the cleaner for the OA equipment to clean the monitor. These substances may cause deterioration of the monitor.
20-1

System Maintenance

4.

Method for cleaning the main panel, shell and bracket Use dry soft cloth to clean the surface of the system. If the system is dirty, moisten the soft cloth with the neutral detergent and wipe off any stains. And then use the dry soft cloth to wipe off moisture from the system or make it air-dried.

5.

Cleaning the trackball

aDisassembling the trackball Press the bulges on the clamping ring by both hands and turn the ring about 45 clockwise until it lifts. Take out the ring and the rotary ball. Be careful not to drop the ball.
Rotary ball Clamping ring Top cover

bCleaning the trackball Clean the two long shafts, the bearing and the rotary ball with soft dry cloth or paper.

cInstalling the trackball Put the rotary ball back in the trackball and then align the clamping ring click with the top cover notch. Press the bulges on the ring with both hands and turn the ring about 45 counterclockwise until the ring clicks. As the bulges are flush with the top cover, the ring is secured.

20-2

System Maintenance

20.1.2 Backup of the system hard disk

To prevent deterioration or loss of data stored in the system hard disk, create a backup copy of the hard disk at appropriate time.

20.2

Maintenance Checks by Service Engineer

The following checks shall be performed to ensure the performance and safety of the system. Contact your Mindray representative when carrying out these checks, since special techniques are required to perform these checks. Check category Cleaning Electric safety Check item Interior of the system Peripheral units Protective conductor resistance Earth leakage current Enclosure leakage current Patient leakage current Patient leakage current (110% mains on applied
part)

Patient auxiliary leakage current Mechanical safety Casters Caster mounting sections Monitor mounting mechanism Main panel Mounting mechanism for the peripheral devices Other mechanical parts External appearance of the transducer Images in each mode Image recording by using the standard transducer

Image recording

20-3

System Maintenance

20.3

Consumable Parts and the Parts of Periodic Replacement

This system contains some parts requiring periodic replacement and some consumable parts. The consumable parts include casters and fuses, etc. For replacement, please contact your Mindray representative for instructions.

20.4

Troubleshooting

To ensure the normal operation of the system, it is recommended to establish the maintenance and inspection plan to periodically check the safety of the system. If any abnormity is detected, contact the sales distributor of Mindray. If there is an abnormality, e.g. after the start-up, there is no image, or there is menu but no image, please check it up first by referring to the table below. If the failure cannot be eliminated, please contact the sales distributor of Mindray.

CAUTION:

1. Do not spill water or other liquid into the system while you perform the cleaning. Otherwise it may result in malfunction or electric shock. 2. When user want to clean transducer connectors and TGC sliders, contact the sales department of Mindray. Cleaning by user self may result in malfunction or degradation of the performance.

20-4

System Maintenance

Troubleshooting Table No. Failure After the power supply is turned on, the power indicator does not light on. When the power indicator of the monitor is on, no image is displayed. The monitor displays the characters and menus but no images. Cause Abnormal power system or incorrect connection of the power cable. 1. The interval between turnoff and restart is too short. 2. The breaker is OFF. 3. The contrast or the brightness of the monitor is in abnormal status. 1. The transmission power, gain or TGC control is abnormal. 2. No transducer is connected or the connection is not correct. 3. The system is in the frozen status. 1. The exam mode is not correct. 2. The settings of the image post processing are not correct. 3. The image presets are impropriety. Measure Check the power system and the power cable to ensure they are in normal status. 1. After turnoff, wait for one minute, and then restart the system. 2. Set the breaker ON. 3. Adjust the contrast or the brightness knob of the monitor. 1. Adjust the transmission power, gain or TGC control. 2. Ensure correct connection. 3. Unfreeze the image.

The image quality is abnormal.

1.

Select an appropriate exam mode. 2. Adjust the settings of the image post processing or set the post processing to the default values. 3. Resume to the factory default presets and retry.

20-5

21

Acoustic Output

This section of the operation manual applies to the overall system including the main unit, transducers, 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.

21.1 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.

21.2 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.

21-1

Acoustic Output

21.3 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.

21.4 MI/TI Explanation

21.4.1 Basic knowledge of MI and TI
(1) Mechanical bioeffect and thermal bioeffect

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. TI and MI models contain practical simplifications to complex bioeffects interaction. Then the operator should be
21-2

Acoustic Output

aware that the actual worst case temperature rise may be up to several times higher than the displayed TI value.

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,
fawf CMI

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). TIS: Thermal index related to soft tissues, such as abdominal and cardiac applications. 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. 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.
21-3

Acoustic Output

Although the output power is automatically controlled for the selected applications, high TI values should be keep to a minimum or avoided in obstetric applications. 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.

(2)

MI/TI

The smaller the MI/TI values, the lower the bioeffects.

21.4.2 MI/TI display

TI and MI values are displayed in real time in the lower part of the screen. The operator should monitor these index values during examinations and insure that exposure time and output values are maintained at the minimum amounts needed for effective diagnosis. Under different operating conditions, once there is a situation that a MI value is greater than 1.0; the start point of displaying MI values is 0.4. In the same way, once there is a situation that a TI value is greater than 1.0, the TI value will be displayed and the start point is 0.4. The user can set which TI item is to be displayed in the preset. Open the "B/THI" page in [Image Parameter] dialogue, and the acoustic output setups appear, as shown in the figure below:

Here the user can preset TIC, TIB or TIS to be displayed, as well as the level of acoustic power. Generally speaking, when a cranial exam is performed, TIC is preset to be displayed only.

NOTE: If there is a value of MI or TI exceeds 1.0, user must be careful to practice ALARA principle.

The display precision is 0.1.

21-4

Acoustic Output

21.5 Acoustic Power Setting

Acoustic power adjustment

Turn the A.Power knob on the main panel to adjust the acoustic power, and the current level is displayed in the lower part of the screen. The higher the acoustic power level, the larger 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 presets can be created using the ultrasound output set by the user. At this time, the default function is disabled. Any changes to the default setting value are the responsibility of the user. Default choices

Initial power

0% 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.

Any value less than 1% is displayed as 0%.

NOTE This system automatically returns to the preset values whenever changes are made to the values (Power ON, Transducer Switch, New Patient, or Return from Preset). In the factory default status, the Acoustic Output is limited below preset values. Following the ALARA restriction, the user is allowed to increase the acoustic power by A.Power knob clockwise under track3 limits and to preset it in image parameter presets.

The acoustic output of the System has been measured and calculated in accordance with the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA UD-2 2004) and the Standard for Real-Time Display of Thermal and
21-5

Acoustic Output

Mechanical Indices on Diagnostic Ultrasound Equipment (AIUM and NEMA UD-3 2004).

21.6 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 (1.) Controls that have direct effect on the output, (2.) Controls that indirectly control output and (3.) Controls that are receiver controls Direct Controls:

It is possible to control, if necessary, the acoustic output with toggle switch Acoustic Power on the operation panel. In this case, the maximum value of the acoustic output never exceeds an MI of 1.9 and an ISPTA.3 of 720 mW/cm2 in any mode of operation. Indirect Controls:

The controls that indirectly affect output are many imaging parameters. There are operating mode, frequency, focal point and depth. The operating mode determines whether ultrasound beam is scanning or non-scanning. Thermal bioeffect is closely concerned with M, PW Doppler and Color Doppler 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 enhance, etc.) do not affect output. They should be used, if possible, to improve the image quality before using controls that directly or indirectly affect output.

21-6

Acoustic Output

21.7 Acoustic Output

21.7.1 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 x10 (0.3 / 10 fc 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 intensity coefficient. 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 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.

21.7.2 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 All regions (except eyes) Ispta.3 (mW/cm2) 720 Isppa.3 (W/cm2) or 190 1.9 MI

21-7

Acoustic Output

21.7.3 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 the user, 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 that the actual value for most tissues within the body. Scanning through muscle or organ tissue, for example, will produce much higher attenuation than0.3 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.

21-8

Acoustic Output

21.8 Measurement Uncertainty

The total estimated measurement uncertainty (where the total uncertainty includes the uncertainties in hydrophone response, measurement, calculation, and positioning) are: Ispta Isppa Center frequency (fc) Total power (W) Rarefactional pressure (pr) 32.9% 32.9% 2% 32.9 % (5.1% for Scan-mode and Combined-mode) 16.4%

21.9 References for Acoustic Power and Safety

(1) (2) (3) Bioeffects and Safety of Diagnostic Ultrasound issued by AIUM in 1993 Medical Ultrasound Safety issued by AIUM in 1994 "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 1997. (6) Medical electrical equipment Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment issued by IEC in 2004.

21-9

22
Table 1
Depth

Measurement Accuracy

Error of two-dimensional images Value range Maximum 263 mm error Within +/- 3%; or when the measured value is less than 40 mm, the error is less than1.5 mm. Within +/- 7%; or when the measured value is less than 16 cm2, the error is less than 1.2 cm2 Within +/- 7%; or when the measured value is less than 16 cm2, the error is less than 1.2 cm2 Within +/- 3% Within +/- 7% Within +/-10 %; or when the measured value is less than 64 cm3, the error is less than 6.4 cm3

Parameter

Area (Trace)

Maximum 1038 cm2

Area (ellipse, circle) Angle % Stenosis Volume

Maximum 814cm2 0~180 Maximum 1.0 Maximum 999cm3

Table 2 Time/Motion Measurements

Parameter Distance Time Heart rate Slope (M mode) Value range Maximum 263mm Maximum 8s 15~999 beats per minute Maximum 999mm/s Error Within +/-3 %; or when the measured value is less than 40mm, the error is less than 1.5mm Within +/- 1% Within +/- 4% Within +/- 4%

Table 3 Doppler velocity measurement

Parameter Velocity Range error

0.053.00m/s

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.

22-1

23
(1)

Safety Classification

According to the type of protection against electric shock: CLASS I EQUIPMENT

(2) According to the degree of protection against electric shock: TYPE-BF EQUIPMENT (3) According to the degree of protection against harmful ingress of water:
The main unit belongs to IPX0, and the transducers belong to IPX7. Footswitch: 971 SWNOM belongs to IPX8.

(4) 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 (5) According to the mode of operation:
CONTINUOUS OPERATION

(6) According to the installation and use:

MOBILE EQUIPMENT

23-1

24

Guidance and Manufacturer's Declaration

The system complies with the EMC standard IEC60601-1-2: 2001+A1:2004.

WARNING:

The use of unapproved accessories may diminish system performance.

NOTE: 1. Use of accessories, transducers, and cables other than those specified may result in increased emission or decreased immunity of system. 2. The system should not be used adjacent to or stacked with other equipment. If adjacent or tacked use is necessary, system 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. 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. 5. 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. 6. Portable and mobile RF communications equipment can affects system. See tables 1, 2, 3, and 4 below.

24-1

Guidance and Manufacturer's Declaration

TABLE 1 GUIDANCE AND MINDRAY DECLARATIONELECTROMAGNETIC 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 RF emissions CISPR 11 RF emissions CISPR 11 Harmonic Emissions IEC61000-3-2 Voltage Fluctuations/Flicker Emissions IEC61000-3-3 Group1 The system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B system is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

Class A

Compliance

24-2

Guidance and Manufacturer's Declaration

TABLE 2 GUIDANCE AND MINDRAY DECLARATIONELECTROMAGNETIC 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 TEST Electrostatic Discharge(ESD) IEC 61000-4-2 Electrical fast Transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 IEC 60601 TEST LEVEL 6 kV contact 8 kV air COMPLIANCE LEVEL 6 kV contact 8 kV air ELECTROMAGNETIC ENVIRONMENT-GUIDANCE Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

2 kV for power supply lines 1 kV for input/output lines 1 kV line(s) to line(s) 2 kV line(s) to earth <5% UT (>95% dip in UT ) for 0.5 cycle 40% UT (60% dip in UT ) for 5 cycle 70% UT (30% dip in UT ) for 25 cycle <5% UT (>95% dip in UT ) for 5 sec

2 kV for power supply lines 1 kV for input/output lines 1 kV line(s) to line(s) 2 kV line(s) to earth <5% UT (>95% dip in UT ) for 0.5 cycle 40% UT (60% dip in UT ) for 5 cycle 70% UT (30% dip in UT ) for 25 cycle <5% UT (>95% dip in UT ) for 5 sec 3 A/m

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, Short interruptions and voltage variation on power supply input lines IEC 61000-4-11

Mains power quality should be that of a typical commercial or hospital environment. If the user of our product requires continued operation during power mains interruptions, it is recommended that our product be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 HZ) magnetic field IEC 61000-4-8 NOTE

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

UT is the A.C. mains voltage prior to application of the test level.

24-3

Guidance and Manufacturer's Declaration

TABLE 3 GUIDANCE AND MINDRAY DECLARATIONELECTROMAGNETIC 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 TEST IEC 60601-1-2 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT-GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the 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).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol:

Conduced RF IEC 1000-4-6

3 Vrms 150kHz to 80MHz

1 Vrms

Radiated RF IEC 1000-4-3

3 V/m 80MHz to 2.5 GHz

3V/m

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. z 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.

24-4

Guidance and Manufacturer's Declaration

TABLE 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION 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. Rated Maximum Output power of Transmitter W 0.01 0.1 1 10 100 Separation Distance According to Frequency of Transmitter m 150kHz -80MHz 80MHz -800MHz 800MHz -2.5GHz

d = 3 .5 P
0.35 1.11 3.50 11.07 35.00

d = 1 .2 P
0.12 0.37 1.17 3.69 11.67

d = 2 .3 P
0.23 0.74 2.34 7.38 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.

24-5

DICOM

Appendix A DICOM
The DICOM package is optional, so the description here is only applicable for the system which has the DICOM package. The DICOM package is used for the data files transfer through network (also referred to as remote file transfer), and the file format is *.DCM.

A.1 DICOM Preset

Select the [DICOM Preset] item in the Preset menu to enter the DICOM preset screen, as shown in the figure below:

The table below will describe the preset items of DICOM and their meaning:

A-1

DICOM

No. 1 2 3

Item name

Meaning

System AE Title The name that has been set in the AE Title field of Local preset column is displayed. Institution Name Set the hospital name. Local (1) AE Title Set the AE title of the local system. This name is the same as that set in the System AE Title field. Set the host name of the local system. Set the IP address of the local system. Set the port number of the local system. Set the alias of the local system. Maximum PDU transmission size in bytes (does not need to be changed). This setting can be changed in the range from 4K to 64K. If a value more than 64K is entered, a value of 16K is set. Set the AE title of the remote system. Set the host name of the remote system. Set the IP address of the remote system. Set the port number of the remote system. Set the alias of Server1/Server2. Maximum PDU reception size in bytes (does not need to be changed). This setting can be changed in the range from 4K to 64 K. If a value less than 4K or more than 64K is entered, a value of 16K is set.

(2) Host Name (3) IP Address (4) Port (5) Alias (6) Packet Size

Server1/Server2 (1) AE Title (2) Host Name (3) IP Address (4) Port (5) Alias (6) Packet Size

5 6 7 8 9 10 11

Verify Current Save Server

After set the information of Server, click this button to verify the server is connected or not. Select the current save server.

Current Worklist Select the worklist server. Server Subnet Mask Code Gateway OK Cancel Set the subnet mask. Set the gateway. When this button is clicked, the changed parameters are saved and the window is closed. When this button is clicked, the window is closed without saving the changed parameters.

A-2

DICOM

A.2

DICOM Operation

If the system is installed with the DICOM package, you can perform the operations as follows: 1. 2. Press the Freeze key to freeze the image. Press the Menu key to open the freeze menu, Move the cursor onto the [DICOM] item and open its submenu.

1. 2.

Send IMG
Move the cursor onto the [Send IMG] item and click theSetkey. The prompt message is displayed as Sending data at the bottom of the screen. And the screen will display the message of successful sending after the sending is complete.

Function: You can send the current scanning images to the DICOM server.

1.

Send Cine
Move the cursor onto [Send Cine], and press the Set key, and then the images are to be send. 2. After the sending is complete, the screen will display the message showing that the sending is successful.

Function: to send the currently-scanning cine images to the server.

1.

Send File
Move the cursor onto [Send File], and press the Set key. The Open File dialog box appears on the screen. After the desired file is selected, sending starts. 2. After the sending is complete, the screen will display the message showing that the sending is successful.

Function: to send the local DCM files to the DICOM server.

A-3

P/N: 2105-20-40466 (V1.1)