Gima CHISON QBit5 ECOCOLOURDOPPLER User guide

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Digital Color Doppler Ultrasound System
QBit 3/QBit 5
Operation Manual
V1.1 Dec. 2019
CHISON Medical Technologies Co., Ltd.
We reserve the right to make changes to this manual without prior notice.
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Digital Color Doppler Ultrasound System
Regulatory Requirement
This product conforms to the essential requirements of the
Medical Device Directive 93/42/EEC. Accessories without the CE mark are not guaranteed to meet the Essential Requirements of the Medical Device Directive.
This manual is a reference for the QBit 3/QBit 5. Please verify that you are using the latest revision of this document. If you need the latest revision, please contact your
distributor.
Statement
1. No part of this manual may be reproduced, modified, copied or reprinted, in whole or in part, without written permission from CHISON.
2. The contents of this manual are subject to change without prior notice and without our legal obligation.
3. Before operating the system, please read and understand this manual. After reading, keep this manual in an easily accessible place. If you have any question or doubt, please contact CHISON's authorized service engineer.
4. CHISON’s Warranty only cover material and parts costs for repair, but does not cover any labor cost or onsite service cost at end user's side.
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Digital Color Doppler Ultrasound System
Warning words
Meaning
NOTE
Indicates information of interest to users of the equipment as to exceptional conditions or operating procedures and make the system work in good condition.
WARNING
Indicates an imminently hazardous situation which can not be avoided will result in death, serious injury to the user or damage to the system.
CAUTION
Indicates a potentially hazardous situation which can not be avoided, may result in death, serious injury to the user or make the system misoperation.
CAUTION:
1. Federal law restricts the device to sale by or on the order of a licensed practitioner or
therapist.
2. It is prohibited to use the device for fetal sex examination, except for necessary medical
needs.
3. The device can only be sold to qualified medical institutions or doctors.
4. The users shall have got the qualification, and shall comply with the local laws and
regulations, the local religion and customs, etc.
5. The users should read the operation manual carefully before operating the devices. Turning on the device means the users have read the operation manual and accept the listed cautions, warnings, and notes in the manuals. If the users disagree and cannot accept the cautions, the users can ask for returning the device.
Meaning of the signal words
In this manual, the warning words NOTE, CAUTION and WARNING are used for regarding safety and other important instructions. Please understand their meanings clearly before reading this manual. The words and their meanings are defined as follows:
Important information
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Digital Color Doppler Ultrasound System
NOTE:
1. It is the customer’s responsibility to maintain and manage the system after delivery.
2. The warranty does not cover the following items, even during the warranty period:
a. Damage or loss due to misuse or abuse with system and probes, for example, drop the
probe, the liquid or the metal part fall into the system.
b. Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc. c. Damage or loss caused by failure to meet the specified conditions for this system, such as
inadequate power supply, improper installation or environmental conditions.
d. Damage or loss caused by non-approved transportation by CHISON. e. Damage or loss due to use the system outside the region where the system was originally
sold.
f. Damage or loss involving the system purchased from a source other than CHISON or its
authorized agents.
3. Do not make changes or modifications to this system and probes. The System modified or
repaired by people other than CHISON’s qualified service engineers, CHISON shall not be liable for
the system.
4. The system is to provide physicians with data for clinical diagnosis. It is the physician’s
responsibility for diagnostic procedures. CHISON shall not be liable for the results.
5. This manual contains warnings regarding foreseeable potential dangers, but user shall
always be alert to dangers other than those indicated as well. CHISON shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions described in this operation manual.
6. Important data must be backed up on external memory media. CHISON shall not be liable for
loss of data stored in the memory of this system caused by operator error or accidents.
7. Please put this manual with the system to ensure operator and manager can reach it at any
time. Due to negligence not following operation manual, CHISON shall not be liable for the results.
8. LED display screen may have some dark or light dots, it is normal for the LED. It does not
mean that LED screen is defective.
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Digital Color Doppler Ultrasound System
CAUTION:
When the above life time is expired, the effectiveness and safety of system and probes maybe greatly affected, so it’s NOT suggested to continue using the system and probes even the system and probes seem work properly. But if user still wants to continue using the system and probes, user should first contact CHISON service center at CHISON headquarter to arrange the necessary safety check and calibration by CHISON’s authorized service engineer. If CHISON headquarter service center provides the calibration certificate for the related system or probe, then user could continue use the system or probes according to the calibration certificate. However, if CHISON headquarter service center concludes that the system or probe is no longer complied to the safety and effectiveness standard, then user should immediately stop using the system or probe. User understands that such check and calibration cost will be born by the user.
Systems and probes keep on using after the life time may also be difficult to repair and
maintain, so it’s suggested to renew the product after the life time.
Service Responsibility
If users install, use and maintain the system fully according to CHISON’s installation manual, operation manual and service manual, then the main unit has a life time of 5 years and probes have life time of 5 years after ex-work. The warranty of the system and probes after ex-work is as the time in the warranty card. The system is a precise electronic system. Only the CHISON’s authorized service engineer could replace the defective parts. Any assembly, disassembly, handling, repair, or replacement by any other people may have adverse impact on the safety and effectiveness of the systems and probes, and thus will reduce the life time of the system and probes, and such systems and probes will not be covered by CHISON warranty after the above improper handling. Standard maintenance must be performed by CHISON’s authorized service engineer during the life time of the product.
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Digital Color Doppler Ultrasound System
Content
Digital Color Doppler Ultrasound System ................................................................................. 1
Chapter 1 Introduction .................................................................................................................. 1
1.1 System Overview .................................................................................................................... 1
1.2 Contact Information ................................................................................................................ 1
Chapter 2 System Safety .............................................................................................................. 3
2.1 Safety Overview ...................................................................................................................... 3
2.2 Electrical Safety ...................................................................................................................... 4
2.3 Label ......................................................................................................................................... 7
2.4 Patient Environmental Devices ............................................................................................ 9
2.5 Biological Safety ................................................................................................................... 11
2.6 Scanning Patients and Education ...................................................................................... 13
Chapter 3 System Introduction .................................................................................................. 21
3.1 Console View ........................................................................................................................ 21
3.2 Physical Specification .......................................................................................................... 22
3.3 External Interface View ........................................................................................................ 22
3.4 Key System Features........................................................................................................... 24
3.5 Installation Procedures ........................................................................................................ 27
Chapter 4 Control Panel .............................................................................................................. 37
4.1 Keyboard Appearance ......................................................................................................... 37
4.2 Alphanumeric Keyboard ...................................................................................................... 38
4.3 Function Keys/Knobs ........................................................................................................... 38
4.4 Central Control ...................................................................................................................... 41
4.5 Information Area Indicating Machine Status ..................................................................... 42
Chapter 5 Operation and Exam Mode ...................................................................................... 43
5.1 Preparing the System for Use ............................................................................................ 43
5.2 Choose Exam Mode............................................................................................................. 43
5.3 Patient Data Entry ................................................................................................................ 44
5.4 Image Interface Display ....................................................................................................... 45
5.5 Image Mode .......................................................................................................................... 45
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5.6 B Image Menu & Parameters ............................................................................................. 52
5.7 M Image Menu & Parameters ............................................................................................. 55
5.8 CFM/CPA/DPD/TDI Image Menu & Parameters ............................................................. 56
5.9 PW/CW Image Menu & Parameters .................................................................................. 57
5.10 Image and Cine Disposition .............................................................................................. 57
5.11 Edit Comment ..................................................................................................................... 59
5.12 Set Body Mark .................................................................................................................... 61
5.13 Set the Direction of Arrow ................................................................................................. 62
5.14 Image Browse ..................................................................................................................... 62
5.15 Archive Management ......................................................................................................... 64
5.16 Report .................................................................................................................................. 65
5.17 DICOM ................................................................................................................................. 66
Chapter 6 Measurement and Calculation................................................................................. 69
6.1 Keyboard for Measurement ................................................................................................ 69
6.2 B Mode General Measurement Methods .......................................................................... 70
6.3 B Fast Measurement ............................................................................................................ 74
6.4 B General Measurement ..................................................................................................... 75
6.5 B Abdomen Measurement .................................................................................................. 76
6.6 B OB Measurement .............................................................................................................. 77
6.7 B Pediatrics Measurement .................................................................................................. 80
6.8 B ORTH Measurement ........................................................................................................ 81
6.9 B GYN Measurement ........................................................................................................... 82
6.10 B Small Parts Measurement ............................................................................................. 83
6.11 B Vascular Measurement .................................................................................................. 83
6.12 B Urology Measurement ................................................................................................... 83
6.13 B Cardiology Measurement .............................................................................................. 84
6.13 Normal Measurement in M, B/M mode ........................................................................... 87
6.14 General Measurement in M mode ................................................................................... 88
6.15 M Cardiology Measurement.............................................................................................. 88
6.16 Other Urology Measurement in M Mode ......................................................................... 90
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6.17 PW mode measurement methods ................................................................................... 90
6.18 PW Fast Measurement ...................................................................................................... 92
6.19 PW General Measurement ............................................................................................... 92
6.20 PW OB Measurement ........................................................................................................ 94
6.21 PW GYN Measurement ..................................................................................................... 94
6.22 PW Cardiology Measurement .......................................................................................... 95
6.23 PW Vascular Measurement ............................................................................................ 100
6.24 Other Urology Measurement in PW Mode ................................................................... 100
Chapter 7 Preset ......................................................................................................................... 101
7.1 General setting .................................................................................................................... 101
7.2 Measurement ...................................................................................................................... 104
7.3 Comment ............................................................................................................................. 113
7.4 Body marks.......................................................................................................................... 116
7.5 Exam Mode ......................................................................................................................... 117
7.6 Report ................................................................................................................................... 121
7.7 DICOM ................................................................................................................................. 124
7.8 Network ................................................................................................................................ 125
7.9 System ................................................................................................................................. 126
Chapter 8 System Maintenance ............................................................................................... 128
8.1 Machine Cleaning ............................................................................................................... 128
8.2 Safety Check ....................................................................................................................... 128
8.3 Malfunction Check .............................................................................................................. 129
Chapter 9 Probes ....................................................................................................................... 130
9.1 General Description ........................................................................................................... 130
9.2 Care and Maintenance ...................................................................................................... 130
9.3 Probe Operation Instructions ............................................................................................ 143
Appendix A: Acoustic Output Report Table .......................................................................... 146
Appendix B: Guidance and Manufacturer’s Declaration .................................................... 232
Appendix C: Measurement Results Summary ...................................................................... 236
Appendix D: Display Accuracy and Acoustic Measurement Uncertainties ..................... 237
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Appendix E: Transducer Maximum Surface Temperature .................................................. 238
Appendix F: Procedures of setting network sharing........................................................... 239
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Digital Color Doppler Ultrasound System
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CHISON website
www.chison.com
Service Support
CHISON Medical Technologies Co., Ltd. Tel:0086-0510-85311707 Fax: 0086-0510-85310726 E-mail: service@chison.com.cn
Placing an Order
CHISON Medical Technologies Co., Ltd. Tel: 0086-0510-8531-0593/0937 Fax: 0086-0510-85310726 Email: export@chison.com.cn
Chapter 1 Introduction
This manual contains necessary information for safe system operation. Read and understand all instructions in this manual before operating the system. Always keeping this manual with the equipment, and periodically review the procedures for operation and safety precautions.
1.1 System Overview
Indications for Use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Adult Cephalic, Cardiac(adult, pediatric), Musculo-skeletal(Conventional, Superficial), Peripheral Vascular, Transrectal, Transvaginal, Urology.
Contraindication
The system is NOT intended for ophthalmic use or any use that causes the acoustic beam to pass through the eye.
1.2 Contact Information
For additional information or assistance, please contact your local distributor or the appropriate support resource shown below:
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Manufacturer
CHISON Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang Industrial Park, Xinwu District, Wuxi, Jiangsu, China, 214142 No.9, Xinhuihuan Road, Xinwu District, Wuxi, Jiangsu, China 214028
US Agent
Mr. Marco Mu, 2219 Rimland Drive,Suite 301,Bellingham, Barkley Villiage Bellingham,Washington,98226, UNITED STATES Phone: 360-3257028, Fax: 360-9253199, Email: us.agent@mid-link.net MID-LINK INTERNATIONAL CO., LTD
EC Representative
Shanghai International Holding Corp.GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg, Germany Tel: 0049-40-2513175 Fax: 0049-40-255726 E-mail: antonsissi@hotmail.com shholding@hotmail.com
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Digital Color Doppler Ultrasound System
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Chapter 2 System Safety
2.1 Safety Overview
This section discusses the measures to ensure the safety of both the operator and patient. To ensure the safety of both operator and patient, please read the relevant details in this chapter carefully before operating this system. Disregarding the warnings or violation of relevant rules
may result in personal injury for operator or patient, or even loss of life.
Users should observe the following precautions:
This system complies with Type BF general equipment, and the IEC standard. Please follow this operation manual to use this system properly. Please do not modify this system in any way. If modifications are necessary, please contact the manufacturer first to get more information and permission.
This system has been fully adjusted at the factory. Do not adjust any fixed adjustable parts. In the event of a malfunction, turn off the system immediately and inform the manufacturer or its
designated agents. The power cord of the system should be connected to a grounded power socket. Do not remove the ground cable for any reason. Only connect this system, either electronically or mechanically, with devices that comply with the IEC/EN60601-1 standard. Recheck the leakage current and other safety performance indices of the entire system to avoid potential system damage caused by leakage from a current superposition. The system does not incorporate any specialized protective measures in the event it is configured with high-frequency operation devices. The operator should use caution in these types of applications. The system should be installed only by personnel authorized by the manufacturer. Do not attempt to install the system by yourself.
Only a CHISON's authorized service engineer can perform maintenance. Only a qualified operator, or someone under qualified supervision, can use the system. Do not use this system in the presence of flammable substances, otherwise an explosion may
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occur. Do not continuously scan the same part of a patient or expose the patient to prolonged scanning. Otherwise, it may harm the patient. When using the system for ultrasound testing, only use qualified ultrasound gel that complies with system standards. Do not unplug probe when the system is in active operation. Always go to transducer Selection screen when need to remove the probe. To prevent from arm or neck injury, the operator should not stay at the same position for too long during patient scanning without taking break.
Do not put liquid on top of the main unit. If there is any liquid or metal to enter to the system, please power off the system and stop using
it immediately. Please first contact CHISON’s authorized service engineer to make sure it’s safe
before restarting to use it.c
NOTE:
* The system has built-in screen saver to avoid the tic mark on the display. It is not recommended to constantly turn on and off the unit.
* To dispose of this product properly, please contact the local CHISON’s Authorized Service
Representative.
2.2 Electrical Safety
Type of protection against electric shock
Class I Equipment
CLASS I EQUIPMENT in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in that accessible conductive parts are connected to the protective earthing conductor in the electrical installation in such a way that accessible parts cannot become live in the event of a failure of the basic insulation.
Degree of protection against electric shock
Type BF Applied part (for Probes marked with BF symbol) TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with
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particular regard to allowable LEAKAGE CURRENT.
Level of protection against harmful ingress of water
Parts of probe likely to come into contact with operator or patient meet the requirements of drip-proof equipment (IPX1) Parts of probe intended to be immersed in normal use meet the requirements of watertight equipment (IPX7). The IP Classification of System is Ordinary Equipment (IPX0)
The Equipment is not suitable for use in the presence of a flammable anesthetic mixed with air (with oxygen or with oxide)
Mode of operation
Continuous Operation For maximum safety, always follow these guidelines: Proper grounding of the system is critical to avoid electric shock. For protection, ground the chassis with a three-wire cable and plug the system into a hospital-grade, three-hole outlet.
Do not remove or circumvent the grounding wire. Do not remove the protective covers on the system. These covers protect users against
hazardous voltages. Cabinet panels must remain in place while the system is in use. A qualified electronic technician must make all internal replacements.
Do not operate this system in the presence of flammable gases or anesthetics. All peripheral devices (unless certified as medical grade) that are connected to the system must
be powered through the electrical outlet with an optional isolation transformer.
Notice upon Installation of Product
Separation distance and effect from fixed radio communications equipment: 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 transmitter 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
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in the location in which the ultrasound system is used exceeds the applicable RF compliance level as stated in the immunity declaration, the ultrasound system should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as re-orienting or relocating the ultrasound system or using an RF shielded examination room may be necessary.
Use either power supply cords provided or designated by CHISON. Products equipped with a power source plug should be plugged into the fixed power socket which has the protective grounding conductor. Never use any adaptor or converter to connect with a power source plug (e.g. three-prong-to-two-prong converter).
Locate the equipment as far away as possible from other electronic equipment. Be sure to only use the cables provided by or designated by CHISON. Connect these cables
following the installation procedures (e.g. wire power cord separately from signal cables). Lay out the main equipment and other peripherals following the installation procedures described in this manual.
Notice against User Modification
The user should never modify this product. User modifications may cause degradation in Electrical Safety. Modification of the product includes changes in:
Cables (length, material, wiring, etc.) System configuration/components
User modifications may cause degradation in EMC performance. Modification of the product includes changes in:
Cables (length, material, wiring, etc.) System installation/layout System configuration/components Securing system parts (cover open/close, cover screwing)
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2.3 Label
Icon
Meaning
Do not use the following devices near this equipment: cellular phone, radio receiver, and mobile radio transmitter, radio controlled toy, etc. Use of these devices near this equipment could cause this equipment to perform outside the published specifications. Keep power to these devices turned off when near this equipment.
This mark indicates that this product contains a limited amount of hazardous substances in the Chinese Standard GB/T 26572-2011 "Limited Requirements for Restricted Substances in Electrical and Electronic Products". The numbers in the logo are the environmental protection use period of the product, indicating that under the normal use conditions, the harmful substances will not leak or be abrupt. The use of the product will not cause serious pollution to the environment or cause personal or property serious damage, the term unit is year.
Refer to instruction manual/booklet.
Caution, consult accompanying documents. This symbol advises the reader to consult the accompanying documents for important safety related information such as warnings and pre-cautions that cannot be presented on the device itself.
WASTE OF ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE): This symbol is used for Environment Protection, it indicates that the waste of electrical and electronic equipment must not be disposed as unsorted waste and must be
Digital Color Doppler Ultrasound System
Rear panel label
2.3.1 Warning Symbols on Label
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collected separately. Please contact your local Authority or distributor of the manufacturer for information concerning the decommissioning of your equipment.
The CE mark of Conformity indicates this equipment conforms to the Council Directive 93/42/EEC.
Rx only
This symbol indicates that federal law restricts the device to sale by or on the order of a licensed practitioner or therapist in the united states.
AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY: This symbol is accompanied by the name and the address of the authorized representative in the European Community.
MANUFACTURER: This symbol is accompanied by the name and the address of the manufacturer.
Manufacturing date of the device in the form YYYY-MM. Serial number of the device.
The “Alternating current” symbol indicates that the equipment is suitable for alternating current only.
Icon
Meaning
Power On/off CAUTION: This Power Switch cannot isolate Mains Supply completely.
Type-BF applied part
Main power switch ON
Main power switch OFF
Potential equilibrium connection
IPX0
No protection against ingress of water (system)
IPX7
Protection against the effects of immersion (probes)
2.3.2 Symbols used in the system
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2.4 Patient Environmental Devices
Right side:
2 Probe ports (standard) 2 USB ports on control panel
Rear panel:
4 USB ports 1 VIDEO OUT port 1 DVI port 1 VGA port 1 Remote port
Digital Color Doppler Ultrasound System
1 ECG port 2 Footswitch ports 1 LAN port 1 S-VIDEO port 1 Power in port 1 Power out port
Acceptable Devices
The Patient Environmental devices shown above are specified to be suitable for use within the PATIENT ENVIRONMENT.
CAUTION:
DO NOT connect any probes or accessories without approval by CHISON within the PATIENT ENVIRONMENT. DO NOT touch patient and devices without IEC/EN 60601-1 approval to avoid the leakage current risk within the PATIENT ENVIRONMENT.
Unapproved Devices
CAUTION:
DO NOT use unapproved devices. If devices are connected without the approval of CHISON, the warranty will be INVALID.
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The system can’t be used with HF surgical equipment; otherwise the burns to patient may
occur.
Any device connected to this system must conform to one or more of the requirements listed below:
IEC standard or equivalent standards appropriate to devices. The devices shall be connected to PROTECTIVE EARTH (GROUND).
CAUTION:
Unsafe operation or malfunction may occur. Use only the accessories, options and supplies approved or recommended in these instructions for use.
Peripheral used in the patient environment
The system has been verified for overall safety, compatibility and compliance with the following on-board image recording devices: B/W video printer: SONY UP-X898MD The system may also be used safely while connected to devices other than those recommended above if the devices and their specifications, installation, and interconnection with the system conform to the requirements of IEC/EN 60601-1.
The connection of equipment or transmission networks other than as specified in the user instructions can result in an electric shock hazard or equipment malfunction. Substitute or alternate equipment and connections require verification of compatibility and conformity to IEC/EN 60601-1 by the installer. Equipment modifications possible resulting malfunctions and electromagnetic interference are the responsibilities of the owner. General precautions for installing an alternate off-board, remote device or a network would include:
The added device(s) must have appropriate safety standard conformance and CE Marking. There must be adequate mechanical mounting of the device and stability of the combination. Risk and leakage current of the combination must comply with IEC/EN 60601-1. Electromagnetic emissions and immunity of the combination must conform to IEC/EN
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60601-1-2.
Peripheral used in the non-patient environment
The system has been verified for compatibility, and compliance for connection to a local area network (LAN) via a wire LAN. The provided LAN components are IEC/EN 60950 compliant.
General precautions for installing an alternate off-board, remote device or a network would include:
The added device(s) must have appropriate safety standard conformance and CE Marking. The added device(s) must be used for their intended purpose having a compatible interface.
CAUTION: Make sure using ONLY the dedicated USB disk or removable media to save
or back up data. Before connecting to the ultrasound system, make sure using the latest antivirus
software on the USB disk or removable media to clean any virus. It is user’s responsibility to
ensure the USB disk or removable media is virus-free. Improper use of USB disk or removable media may cause the virus infections of system and eventually malfunction may occur. Such malfunction may impact the stability, effectiveness and safety of the system and probes, and users should immediately stop using the system and probes until CHISON authorized engineer has checked the system and confirm the effectiveness and safety of the system and probes.
CAUTION: Use only secure Local Area Network connection. Don’t connect the
ultrasound system to Internet. Make sure your hospital’s firewall software is configured correctly, thus blocking incoming connection requests from Internet. Improper use of network connection may cause the virus infections of system and eventually malfunction may occur.
2.5 Biological Safety
This product, as with all diagnostic ultrasound equipment, should be used only for valid reasons and should be used both for the shortest period of time and at the lowest power settings necessary (ALARA - As Low As Reasonably Achievable) to produce diagnostically acceptable images. The AIUM offers the following guidelines:
Clinical Safety Quoted from AIUM
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Approved March 26, 1997
Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use: There are no confirmed biological effects on patients or instrument operators caused by exposures from present diagnostic ultrasound instruments. Although the possibility exists that such biological effects may be identified in the future, current data indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any that may be present.
Heating: Elevating tissue temperature during obstetrical examinations creates medical concerns. At the embryo development stage, the rise in temperature and the length of time exposed to heat combine to determine potential detrimental effects. Exercise caution particularly during Doppler/Color exams. The Thermal Index (TI) provides a statistical estimate of the potential temperature elevation (in centigrade) of tissue temperature. Three forms of TI are available: Soft Tissue Thermal Index (TIS), Bone Thermal Index (TIB) and Cranial Bone Thermal Index (TIC).
Soft Tissue Thermal Index (TIS). Used when imaging soft tissue only, it provides an estimate of potential temperature increase in soft tissue. Bone Thermal Index (TIB). Used when bone is near the focus of the image as in the third trimester OB examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue. Cranial Bone Thermal Index (TIC). Used when bone is near the skin surface as in transcranial examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue.
Cavitations: Cavitations may occur when sound passes through an area that contains a cavity, such as a gas bubble or air pocket (in the lung or intestine, for example). During the process of cavitations, the sound wave may cause the bubble to contract or resonate. This oscillation may cause the bubbles to explode and damage the tissue. The Mechanical Index (MI) has been created to help users accurately evaluate the likelihood of cavitations and the related adverse effects.
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MI recognizes the importance of non-thermal processes, cavitations in particular, and the Index is an attempt to indicate the probability that they might occur within the tissue.
2.6 Scanning Patients and Education
The Track-3 or IEC60601-2-37 output display standard allows users to share the responsibility for the safe use of this ultrasound system. Follow these usage guidelines for safe operation:
In order to maintain proper cleanliness of the probes, always clean them between patients. Always use a disinfected sheath on all EV/ER probes during every exam. Continuously move the probe, rather than staying in a single spot, to avoid elevated
temperatures in one part of the patient’s body.
Move probe away from the patient when not actively scanning. Understand the meaning of the TI, TIS, TIB, TIC and MI output display, as well as the
relationship between these parameters and the thermal/cavitation bio effect to the tissue. Expose the patient to only the very lowest practical transmit power levels for the shortest possible time to achieve a satisfactory diagnosis (ALARA - As Low As Reasonably Achievable).
2.6.1 Safe Scanning Guidelines
Ultrasound should only be used for medical diagnosis and only by trained medical personnel.
Diagnostic ultrasound procedures should be done only by personnel fully trained in the use of
the equipment, in the interpretation of the results and images, and in the safe use of ultrasound (including education as to potential hazards to the patient and the operator).
Operators should understand the likely influence of the machine controls, the operating mode (e.g. B-mode, color Doppler imaging or spectral Doppler) and probe frequency on thermal and cavitations hazards.
Select a low setting for each new patient. Output should only be increased during the examination if penetration is still required to achieve a satisfactory result, and after the Gain control has been adjusted to its maximum value.
Maintain the shortest examination time necessary to produce a useful diagnostic result.
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Do not hold the probe in a fixed position for any longer than is necessary. It should be removed from the patient whenever there is no need for real-time imaging or spectral Doppler acquisition. The frozen frame and Cine loop capabilities allow images to be reviewed and discussed without exposing the patient to continuous scanning.
Do not use endo-cavitary probes if there is noticeable self heating of the probe when operating in the air. Although applicable to any probe, take particular care during trans- vaginal exams during the first eight weeks of gestation.
Take particular care to reduce output and minimize exposure time of an embryo or fetus when the temperature of the mother is already elevated.
Take particular care to reduce the risk of thermal hazard during diagnostic ultrasound when exposing: an embryo less than eight weeks after gestation; or the head, brain or spine of any fetus or neonate.
Operators should continually monitor the on-screen thermal index (TI) and mechanical index (MI) values and use control settings that keep these settings as low as possible while still achieving diagnostically useful results. In obstetric examinations, TIS (soft tissue thermal index) should be monitored during scans carried out in the first eight weeks after gestation, and TIB (bone thermal index) thereafter. In applications where the probe is very close to bone (e.g. trans-cranial applications), TIC (cranial bone thermal index) should be monitored. MI> 0.3 There is a possibility of minor damage to neonatal lung or intestine. If such exposure is necessary, reduce the exposure time as much as possible.
MI> 0.7 There is a risk of cavitations if an ultrasound contrast agent containing gas micro-spheres is being used. There is a theoretical risk of cavitations without the presence of ultrasound contrast agents. The risk increases with MI values above this threshold.
TI> 0.7 The overall exposure time of an embryo or fetus should be restricted in accordance with Table 2-2 below as a reference:
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TI
Maximum exposure time
(minutes)
0.7
60
1.0
30
1.5
15
2.0
4
2.5
1
Maximum recommended exposure times for an embryo or fetus
Non-diagnostic use of ultrasound equipment is not generally recommended. Examples of non-diagnostic uses of ultrasound equipment include repeated scans for operator training, equipment demonstration using normal subjects, and the production of souvenir pictures or videos of a fetus. For equipment of which the safety indices are displayed over their full range of values, the TI should always be less than 0.5 and the MI should always be less than 0.3. Avoid frequent repeated exposure of any subject. Scans in the first trimester of pregnancy should not be carried out for the sole purpose of producing souvenir videos or photographs, nor should their production involve increasing the exposure levels or extending the scan times beyond those needed for clinical purposes.
Diagnostic ultrasound has the potential for both false positive and false negative results. Misdiagnosis is far more dangerous than any effect that might result from the ultrasound exposure. Therefore, diagnostic ultrasound system should be performed only by those with sufficient training and education.
2.6.2 Understanding the MI/TI Display
Track-3 follows the Output Display Standard for systems that include fetal Doppler applications. The acoustic output will not be evaluated on an application-specific basis, but the global maximum de-rated Ispta must be ≤ 720 mW/cm2 and either the global maximum MI must be ≤ 1.9 or the global maximum de-rated Isppa must be ≤ 190 W/cm2. An exception is for ophthalmic use, in
which case the TI=max (TIS_as, TIC) is not to exceed 1.0; Ispta.3 ≤50mW/cm2, and MI ≤ 0.23.
Track-3 gives the user the freedom to increase the output acoustic power for a specific exam, and still limit output acoustic power within the global maximum de-rated Ispta ≤ 720 mW/cm2 under an Output Display Standard.
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For any diagnostic ultrasonic systems, Track-3 provides an Output Indices Display Standard. The diagnostic ultrasound systems and its operation manual contain the information regarding an ALARA (As Low As Reasonably Achievable) education program for the clinical end-user and the acoustic output indices, MI and TI. The MI describes the likelihood of cavitations, and the TI offers the predicted maximum temperature rise in tissue as a result of the diagnostic examination. In general, a temperature increase of 2.5°C must be present consistently at one spot for 2 hours to cause fetal abnormalities. Avoiding a local temperature rise above 1°C should ensure that no thermally induced biologic effect occurs. When referring to the TI for potential thermal effect, a TI equal to 1 does not mean the temperature will rise 1 degree C. It only means an increased potential for thermal effects can be expected as the TI increases. A high index does not mean that bioeffects are occurring, but only that the potential exists and there is no consideration in the TI for the scan duration, so minimizing the overall scan time will reduce the potential for effects. These operator control and display features shift the safety responsibility from the manufacturer to the user. So it is very important to have the Ultrasound systems display the acoustic output indices correctly and the education of the user to interpret the value appropriately.
RF: (De-rating factor) In Situ intensity and pressure cannot currently be measured. Therefore, the acoustic power
measurement is normally done in the water tank, and when soft tissue replaces water along the ultrasound path, a decrease in intensity is expected. The fractional reduction in intensity caused by attenuation is denoted by the de-rating factor (RF),
RF=10 (-0.1 a f z)
Where a is the attenuation coefficient in dB cm-1 MHz-1, f is the transducer center frequency, and z is the distance along the beam axis between the source and the point of interest.
De-rating factor RF for the various distances and frequencies with attenuation coefficient 0.3dB cm-1 MHz-1 in homogeneous soft tissue is listed in the following table. An example is if the user uses 7.5MHz frequency, the power will be attenuated by .0750 at 5cm, or 0.3x7.5x5=-11.25dB. The De- rated Intensity is also referred to as ‘.3’ at the end (e.g. Ispta.3).
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Distance
Frequency (MHz)
(cm) 1 3 5 7.5
1
0.9332
0.8128
0.7080
0.5957
2
0.8710
0.6607
0.5012
0.3548
3
0.8128
0.5370
0.3548
0.2113
4
0.7586
0.4365
0.2512
0.1259
5
0.7080
0.3548
0.1778
0.0750
6
0.6607
0.2884
0.1259
0.0447
7
0.6166
0.2344
0.0891
0.0266
8
0.5754
0.1903
0.0631
0.0158
Thermal Models
Composition
Mode
Specification
Application
1
TIS
Soft tissue
Unscanned
Large aperture (>1cm2)
Liver PW 2 TIS
Soft tissue
Unscanned
Small aperture (<1cm2)
Pencil Probe
3
TIS
Soft tissue
Scanned
Evaluated at surface
Breast color
4
TIB
Soft tissue and bone
Scanned
Soft tissue at surface
Muscle color
5
TIB
Soft tissue and bone
Unscanned
Bone at focus
Fetus head PW
6
TIC
Soft tissue and bone
Unscanned/scann ed
Bone at surface
Transcranial
I’=I*RF Where I’ is the intensity in soft tissue, I is the time-averaged intensity measured in water.
Tissue Model: Tissue temperature elevation depends on power, tissue type, beam width, and scanning mode. Six
models are developed to mimic possible clinical situations.
Soft tissue: Describes low fat content tissue that does not contain calcifications or large gas-filled spaces.
Scanned: (auto-scan) Refers to the steering of successive burst through the field of view, e.g. B and color mode.
Unscanned: Emission of ultrasonic pulses occurs along a single line of sight and is unchanged until the transducer is moved to a new position. For instance, the PW, and M mode.
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TI: TI is defined as the ratio of the In Situ acoustic power (W.3) to the acoustic power required to raise tissue temperature by 1°C (Wdeg), TI=W.3/Wdeg. Three TIs corresponding to soft tissue (TIS) for abdominal; bone (TIB) for fetal and neonatal cephalic; and cranial bone (TIC) for pediatric and adult cephalic, have been developed for applications in different exams. An estimate of the acoustic power in milli-watts necessary to produce a 1°C temperature elevation in soft tissue is:
Wdeg=210/fc,for model 1 to 4, where fc is the center frequency in MHz.
Wdeg=40 K Dfor model 5 and 6, where K (beam shape factor) is 1.0, D is the aperture diameter in cm at the depth of interest.
MI: Cavitation is more likely to occur at high pressures and low frequencies in pulse ultrasound wave
in the tissue, which contains the bubble or air pocket (for instance, the lung, intestine, or scan with gas contrast agents). The threshold under optimum conditions of pulsed ultrasound is predicted by the ration of the peak pressure to the square root of the frequency.
MI=Pr’/sqrt(fc) Pr’ is the de-rated (0.3) peak rare-fractional pressure in Mpa at the point where PII is the maximum,
and fc is the center frequency in MHz. PII is the Pulse Intensity Integral that the total energy per unit area carried by the wave during the time duration of the pulse. The peak rare- fractional pressure is measured in hydrophone maximum negative voltage normalized by the hydrophone calibration parameter.
Display Guideline: For different operation modes, different indices must be displayed. However, only one index needs
to be shown at a time. Display is not required if maximum MI is less than 1.0 for any setting of the operating mode, or if maximum TI is less than 1.0 for any setting of the operating mode. For TI, if the TIS and TIB are both greater than 1.0, the scanners need not be capable of displaying both indices simultaneously. If the index falls below 0.4, no display is needed. The display increments
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are no greater than 0.2 for index value less than one and no greater than 1.0 for index values greater than one (e.g. 0.4, 0.6, 0.8, 1, 2, and 3).
Display and Report in Different Mode
Located on the upper middle section of the system display monitor, the acoustic output display provides the operator with real-time indication of acoustic levels being generated by the system.
For B-Scan Mode Only display and report MI, and start from 0.4 if maximum MI > 1.0, display in increments of 0.2.
For Color Mode Only display and report TIS or TIB and start from 0.4 if maximum TI > 1.0, display in increments of
0.2 for values of indices of 2.0 or less, and 0.5 for values of indices greater than 2.0.
For Doppler Mode Only display and report TIS or TIB and start from 0.4 if maximum TI > 1.0, display in increments of
0.2 for values of indices of 2.0 or less, and 0.5 for values of indices greater than 2.0.
Below is a simple guideline for the user when TI exceeds one limit exposure time to 4(6-TI)
minutes based on the ‘National Council on Radiation Protection. Exposure Criteria for Medical
Diagnostic Ultrasound: I. Criteria Based on Thermal Mechanisms. Report No.113 1992’.
Operator Control Features: The user should be aware that certain operator controls may affect the acoustic output. It is
recommended to use the default (or lowest) output power setting and compensate using Gain control to acquire an image. Other than the output power setting in the soft-menu, which has the most direct impact on the power; the PRF, image sector size, frame rate, depth, and focal position also slightly affect the output power. The default setting is normally around 70% of the allowable power depending on the exam application mode.
Controls Affecting Acoustic Output The potential for producing mechanical bioeffects (MI) or thermal bioeffects (TI) can be influenced by certain controls. Direct: The Acoustic Output control has the most significant effect on Acoustic Output.
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Indirect: Indirect effects may occur when adjusting controls. Controls that can influence MI and TI are detailed under the bio effect portion of each control in the Optimizing the Image chapter. Always observe the Acoustic Output display for possible effects.
Best practices while scanning HINTS: Raise the Acoustic Output only after attempting image optimization with controls that have no effect on Acoustic Output, such as Gain and STC.
WARNING: Be sure to have read and understood control explanations for each mode
used before attempting to adjust the Acoustic Output control or any control that can affect Acoustic Output.
Use the minimum necessary acoustic output to get the best diagnostic image or measurement during an examination. Begin the exam with the probe that provides an optimum focal depth and penetration.
Acoustic Output Default Levels In order to assure that an exam does not start at a high output level, the system initiates scanning
at a reduced default output level. This reduced level is preset programmable and depends upon the exam icon and probe selected. It takes effect when the system is powered on or New Patient is selected. To modify acoustic output, adjust the Power Output level on the Soft Menu.
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Chapter 3 System Introduction
3.1 Console View
Digital Color Doppler Ultrasound System
Fig. 3-1 Console View
NOTE: The photograph above is adapted for 15 inch monitor. For device of 19 inch monitor
please be subject to the actual product.
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1
2 3 4
3.2 Physical Specification
Dimensions of main unit (approx.):
1.15 inch monitor: 747mm (Length)*517mm (Width)*1283mm (Height)
2.19 inch monitor (option): 747mm (Length) ×517mm (Width) ×1358.23mm (Height) Net weight of main unit (approx.): 50 kg (no probe included)
3.3 External Interface View
Fig. 3-2 Front Side View
1. Monitor 2. Speaker 3. Keyboard 4. Probe holder
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2 1 1 2 3 4 5 8 7
6
Fig. 3-3 Right Side View
1.ECG port 2. Probe ports
Fig. 3-4 Rear panel
1.USB 2.0 ports 2.Remote port 3.LAN port 4.DVI port
5.Foot Switch ports 6.Video Out port 7.S-Video port 8.VGA port
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1 2 4
3
Fig. 3-5 Power panel
1.Power In 2.Power Switch 3. Potential equilibrium connection 4.Power Out
3.4 Key System Features
1. Zoom and depth adjustment.
2. Set the total gain, contrast, frequency band, 8 segments of STC, dynamic range, persistence.
3. 256 gray-scale image display technology, Q-image technology, stable performance, high resolution.
4. Image freezing and storage function; the stored images can be recalled for analysis.
5. Scanning direction can be changed and the image can be reversed in left/right, up/down direction.
6. Distance, area, circumference, volume, fetal weight, heart rate etc. measurements are available and automatic calculation of OB, cardiology are available. Direct display of gestation age and expected date of child delivery.
7. Elliptical method and tracing method are provided for area/circumference measurement.
8. Many kinds of body marks can be displayed together with corresponding probe position indication.
9. Comment function in image area of the screen, special comment terms for different exam mode can be added according to user’s requirement.
10. Display of Patient ID, Time and Date display according to real-time clock.
11. Trackball available for operation and measurement. Characters can be input directly by keyboard.
12. When one function is under operation, the corresponding key on the control panel will be brightly lit. When exiting from the function, the corresponding key on the control panel will be slightly lit.
13. Measure the percentage of stenosis, blood flow velocity, velocity ratio, blood flow volume and pressure gradient. Automatically measure the values of maximum velocity, minimum velocity, time interval, pulsatility index and resistance index.
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Mode
QBit 3
QBit 5
B Mode
Standard
Standard
2 B Mode
Standard
Standard
B/M Mode
Standard
Standard
M Mode
Standard
Standard
4B Mode
Standard
Standard
2D Steer
Standard
Standard
CFM Mode
Standard
Standard
CPA(PD) Mode
Standard
Standard
DPD Mode
Standard
Standard
PW Mode
Standard
Standard
Triplex Mode
Standard
Standard
CW Mode
N/A
Option
TDI
N/A
Option
Color M Mode
N/A
Option
Trapezoidal Mode
Standard
Standard
ECG
N/A
Option
B/BC Mode
Standard
Standard
Super Needle
Option
Option
HD 3D
Option
Option
14. Possess multi-language interface display User interface change, shear plate, printing, DICOM
3.0, biopsy guided functions.
15. It has permanent storage for image and cine on HDD. It can also be connected to removable storage via USB 2.0 port. To realize mass storage ,can recall saved image for analysis.
16. Cine loop storage 256 frames real time image.
17. Output standard PAL or NTSC video signal and VGA/DVI signal.
18. Print or export graphic report.
3.4.1 Image Modes
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3.4.2 Accessories
Probe
Frequency
QBit 3
QBit 5
D3C60L
Convex probe
3.5MHz,
2.0-6.8MHz
Option
Option
D7L40L
Linear probe
7.5MHz,
4.0-15.0MHz
Option
Option
Micro convex probe
D6C12L
6.0MHz,
4.0-12.0MHz
Option
Option
Micro convex probe
D7C10L
7.5MHz,
4.0-15.0MHz
Option
Option
Linear probe
D7L40L-REC
7.5MHz,
4.0-15.0MHz
Option
Option
Micro convex probe
D3C20L
3.0MHz,
2.0-6.8MHZ
Option
Option
Probes:
Digital Color Doppler Ultrasound System
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Micro convex probe
D6C15L
6.0MHz,
4.0-12.0MHz
Option
Option
Micro convex probe
D5C20L
5.0MHz,
4.0-10.7MHz
Option
Option
Phased array probe
D3P64L
2.5MHz,
1.5-5.3MHz
N/A
Option
Linear probe
D12L40L
12.0MHz,
7.0-15.0MHz
Option
Option
Peripherals
S-VIDEO, VGA, DVI output for external monitor VIDEO output for B&W video printer LAN port output LAN for DICOM and image review station USB 2.0 for flash drive Foot Switch
3.5 Installation Procedures
NOTE: Please do not turn on the power switch until finishing all the installation and
necessary preparation.
3.5.1 Environment Condition
The system should be operated under the following environment.
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3.5.1.1 Operation Environment Requirement
Ambient Temperature: 10 40 Relative Humidity: 30%75%RH Atmospheric Pressure: 700hPa1060hPa Strong radiation sources or powerful electromagnetic waves (e.g. electro-magnetic waves from radio broadcasting) may result in image ghosting or noise. The system should be isolated from such radiation sources or electromagnetic waves. To prevent damage to the system, do not use in the following locations:
Exposed to direct sunlight Subject to sudden changes in temperature Dusty Subject to vibration Near heat generators High humidity
NOTE:
This equipment generates, uses and can radiate radio frequency energy. The equipment may cause radio frequency interference to other medical and non-medical devices and radio communications. To provide reasonable protection against such interference, this product complies with emissions limits for a Group 1, Class A Medical Devices Directive as stated in IEC/EN 60601-1-2. However, there is no guarantee that interference will not occur in a particular installation.
If this equipment is found to cause interference (which may be determined by turning the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measure(s):
Reorient or relocate the affected device(s). Increase the separation between the equipment and the affected device. Power the equipment from a source different from that of the affected device. Consult the point of purchase or service representative for further suggestions.
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3.5.1.2 Transport and Storage Environmental Requirement
The following environmental transport and storage conditions are within system tolerances: Temperature: -5 ~ 40 Relative Humidity: ≤ 80% non-condensing Atmosphere Pressure: 700hPa ~ 1060hPa
3.5.1.3 Electrical Requirements
Power Requirements: AC 100-240V, 50-60Hz. Fuse Requirements: Fuse specification is 250V, 5.0 A (time-lag), the model is 50T T5AL 250V.
CAUTION: Please use the fuse provided by manufactory if the fuse need replace. User
can’t buy and exchange the fuse by their self.
Power Consumption: 600 VA. Voltage Fluctuation
WARNING:
Maintain a fluctuation range of less than ±10% of voltage labeling on rear panel of the system, otherwise the system may be damaged.
Grounding
Before connecting the power cable, connect the attached ground protection cable from Equipotentiality terminal on system rear panel to a specialized grounding device.
NOTE:
Please follow the outlined power requirements. Only use power cables that meet the system guidelines-failure to follow these procedures may produce system damage. Line power may vary in different geographic locations. Refer to the detailed ratings on the rear panel of the system for detailed information.
3.5.1.4 Operation Space
Please leave enough free space for the system to ensure well ventilation.
CAUTION: Leave enough free space for the system; otherwise, with the increasing of the
temperature inside the unit, malfunction may occur.
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3.5.2 System Positioning & Transporting
When moving or transporting the system, take the precautions described below to ensure maximum safety for personnel, the system and other equipment.
Before Moving the System
Power off the system, refer to power off section. Switch off the power and unplug the power cord (if the system is plugged into wall outlet). Disconnect all cables from off-board peripheral devices (external printer, etc.) from the console.
NOTE:
To prevent damage to the power cord, DO NOT pull excessively on the cord or sharply bend the cord while wrapping it.
Store all probes in their original cases or wrap them in soft cloth or foam to prevent damage. Replace gel and other essential accessories in the appropriate storage case. Ensure that no loose items are left on the main unit.
When Moving the System
Carry the system with handle, or put the system on the cart to move it. Use extra care when crossing door or elevator thresholds.
NOTE:
Always use the handle to move the system. The system weighs approx. 50 kg. For avoid possible injury or equipment damage.
Walk slowly and carefully when moving the system. Do not let the system strike walls or doorframe.
Transporting the System
Use extra care when transporting the system in a vehicle. After preparing the system as described above, take the following additional precautions: Powering the System
Before transporting, place the system in its original storage case. Ensure that the system is firmly secured while inside the vehicle. Load the unit abroad the vehicle carefully and over its center of gravity.
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Keep the storage case still and upright. Secure that the system firmly with straps or as directed within the vehicle to prevent movement during transport. Any movement, coupled with the weight of the system, could cause it to break loose. Drive carefully to prevent damage from vibration. Avoid unpaved roads, excessive speeds, and erratic stops or starts.
3.5.3 Powering the System
3.5.3.1 Acclimation Time
After being transported, the unit requires one hour for each 2.5 º increment if its temperature is below 10 or above 40 .
NOTE:
Please keep at least 20 to 30 cm spare space away from the back of the system to ensure well ventilation. Otherwise, with the increasing of the temperature inside the unit, malfunction may occur.
3.5.3.2 Connecting the electric power
To connect the system to the electrical supply:
Check the power voltage input labeling at rear panel of the system. Ensure that the wall outlet is the appropriate type and well grounded. Ensure that the system powers off. Unwrap the power cord, and allow sufficient slack in the cable so that the plug will not be pulled
out of the wall outlet if the system is moved slightly.
Attach the power plug to the system and secure it in place by using the retaining clamp. Push the power plug securely into the wall outlet.
NOTE:
Only use the power cord provided by Manufacturer. Use caution to ensure that the power cord does not disconnect during system use. If the system is accidentally unplugged, data may be lost.
WARNING:
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To avoid risk of fire, the system power must be supplied from a separate, properly rated outlet. Under no circumstances should the AC power plug be altered, changed, or adapted to a configuration rated less than specified. Never use an extension cord or adapter plug. To help assure grounding reliability, connect to a “hospital grade” or “hospital only” grounded power outlet.
3.5.3.3 Power on
NOTE:
Turn on the green power switch (main power circuit breaker switch) at the back of the main
unit, and then press the Power button on the control panel to turn on the system.
Starting Sequence
The system is initialized and start-up status is reflected on the monitor:
Control panel initiate Boot up the operation system Load the software Entering into examination status
HINTS
The starting procedure takes about approx. 100 seconds. If a problem occurs, take a picture and record the error information for service reference.
NOTE:
After powering off the system, please wait for 1 minute to power on again. When the system is powered on, for safety reason, please avoid moving the main unit.
3.5.3.4 Power off
To power off the system:
Press on control panel. When the screen shows shut down dialog box, press “shutdown” to shut down the system.
Or press for 4 seconds to shut down the system directly.
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NOTE:
After powering off the system
Disconnect the probes. Clean or disinfect all probes as necessary. Store them in their original cases to avoid any damage. To ensure the system is disconnected from the power source, disconnect power plug from the wall outlet.
3.5.4 Probes
NOTE:
Only use the probes approved by Manufacturer.
Selecting probes
Choose the probe according to the different examination. Begin the scanning session by choosing the correct application and preset for the examination.
Connecting the Probe
When you connect the probes, please ensure that the probe ports are not active. Freeze the image by pressing [Freeze] key to deactivate the probe ports. To connect a probe:
Place the probe’s carrying case on a stable surface and open the case.  Carefully remove the probe and unwrap the probe cord. DO NOT allow head of the probe hang freely. Impact to head of the probe could result in
irreparable damage.
NOTE:
Inspect the probe before and after each use for damage or degradation to the housing, strain relief, lens, seal and connector. DO NOT use a probe that appears damaged until its functional and safe performance is verified. A thorough inspection should be performed during the cleaning process.
Align the connector with the probe port and carefully push into place with the cable facing the back of the system. Turn the probe connector locking lever to “lock” status.
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Carefully position the probe cord so it is free to move and is not resting on the floor. When the probe is connected, the system will be automatically recognized.
CAUTION:
Fault conditions can result in electric shock hazard. DO NOT touch the surface of probe connector that is exposed when the probe is removed. DO NOT touch the patient when connecting or disconnecting a probe.
Take precautions with probe cables. DO NOT bend the cable acutely.
Fig. 3-6 Probe connector “Unlock” status Fig. 3-7 Probe connector “Lock” status
Deactivating the Probe
When deactivating the probe, the probe is automatically placed in a standby mode. To deactivate a probe:
Ensure the system is in freezing mode. Gently wipe off the excess gel from the probe surface. Carefully slide the probe toward the probe holder, and place the probe gently in the probe
holder.
Disconnecting the Probe
Probes can be disconnected when the system is in freezing mode. To disconnect a probe:
Turn the connector locking lever to the “Unlock” position.  Pull the probe and connector straight out of the probe port.  Carefully slide the probe and connector away from the probe port.  Ensure that the head of the probe is clean before placing the probe in its storage box.
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Transporting the Probe
When transporting a probe a long distance, store it in its original carrying case.
Storing the Probe
It is recommended that all probes should be stored in the original carrying case.
Place the probe connector into the carrying case. Carefully wind the cable into the carrying case. Carefully place the probe head into the carrying case. DO NOT use excessive force or impact
on the probe head.
3.5.5 Accessories Installation
CAUTION: Please only use the optional parts provided or suggested by manufacturer!
Using other types of optional devices may cause the damage to the system and the connected optional devices.
3.5.5.1 Video printer installation
1. Put video printer stably.
2. Connect cable of video printer to video port in the back of the device. And connect the other side to video signal output port in the rear side.
3. Connect the printer line to print control port in the printer rear side, and connect the other side to the print control port in the unit rear side.
4. Connect power cable of video printer to power system.
5. Adjust printer parameter preset according to the type of printing paper.
CAUTION: Do not use any other power cable to replace 3-wire power cable manufacturer
provides, otherwise there is a danger of electric shock.
Video printer sign introduction
: Video signal input port
: Video signal output port
: Print control port
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: Video printer switch
3.5.5.2 Graphic & PC printer installation
Put the printer stably; connect printer cable to USB port of the system (right side of control panel or back of the main unit).
Connect the power cable of the printer to power system.
CAUTION: Please see packing list for fundamental configuration!
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Chapter 4 Control Panel
4.1 Keyboard Appearance
Digital Color Doppler Ultrasound System
Fig. 4-1 keyboard appearance
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Icon
Name
Function description
Switch
Turn on or off the system.
Patient
Set up a new patient data, input name and other information.
Probe
Press this key for selecting probe. It can only select the connected probe.
Arrow
Press this key to enter into arrow status. Add arrows or cross icon to the image area.
Comment
Press this key to enter into annotation status, and add annotations in the image area on the screen.
Bodymark
Press this key to enter into body mark working status, select the body mark and confirm the probe scanning position on the screen.
Report
Produce/Save/Recall an examination report.
Print 1 & Print 2
PRINT1: print the screen image by video printer connected to the system. PRINT2: print the report by printer connected to the system (Only report page works). Or print the image in the scanning page; Or print the image in the review page.
4.2 Alphanumeric Keyboard
Fig. 4-2 Alphanumeric Keyboard
The alphanumeric keys are used for inputting patient number, name, character and figure etc.
4.3 Function Keys/Knobs
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Icon
Name
Function description
Angle_Zoom
Press the knob to switch the knob function between Angle and Zoom. Enter into image zoom or adjusting angle. Rotate the knob to adjust the activated function.
Depth_Focus
Press the knob to switch the knob function between Depth and Focus Position. Rotate the knob to adjust the activated function.
B knob
Press the knob to enter into B mode, rotate the knob to adjust the gain of B mode.
C knob
Press the knob to enter into CFM, rotate the knob to adjust the gain of CFM. In 3D mode, rotate this knob to spin the 3D image around X axis.
D knob
Press the knob twice to enter into PW mode, rotate the knob to adjust the gain of PW mode. In 3D mode, rotate this knob to spin the 3D image around Y axis.
M knob
Press the knob once to enter into B/M mode, and press it again to enter into M mode. Rotate the knob to adjust the gain of M mode. In 3D mode, rotate this knob to spin the 3D image around Z axis.
CPA
Press this key to enter into CPA (PD) mode.
CW
Press this key or [UPDATE] key to enter into CW mode. (only for model QBit 5)
TDI
Press this key to enter into TDI mode. (only for model QBit 5)
X-CONTRAST
Press this key to switch the X-CONTRAST parameter.
AIO
Press this key to activate the AIO function.
FHI
Press this key to turn on or off the FHI function.
Full screen
Press this key to enter into or quit full screen display mode.
2B
Press this key to enter into 2B mode.
Invert
Press this key to invert the image from up and down. Or invert the color map of CFM. Or invert the
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Icon
Name
Function description
spectrum of PW/CW.
Cine
Press this key to save the current cine loop.
Save
Press this key to save the current image.
Freeze
Press this key to freeze or unfreeze the current image.
ESC
Press this key can exit measurement, dialog, and menu.
END
Press this key to finish the current exam.
Clear
Press this key to clear all the measurement lines, body mark, and annotations.
Biopsy
Press this key to activate biopsy.
Single B
This key’s function is the same as key B. Display B mode.
4B
Press this key to enter into 4B mode.
Volume
Press the volume key to adjust PW/CW volume.
SYS
The reserved key.
Help
The reserved key.
Review
File management of system, you can view and edit the patient data.
Setup
Press this key to enter into or quit the system setting page.
Q-BEAM
Press this key to turn on or off the Q-beam function.
Q-FLOW
Press this key to turn on or off the Q-flow function.
Change
Press this key to change the menu.
Del
Press this key to delete the measurement, comment step by step.
4.3.1 STC
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STC can be used for adjusting gain compensation in different image depth.
4.3.2 Parameter Control Keys/Knobs
Increase/decrease the corresponding parameters of the screen, or activate/deactivate the function.
4.4 Central Control
1.UPDATE 2.EXIT 3.CURSOR 4.CLEAR 5.MENU
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Name
Function description
ENTER
This multifunctional key is work with trackball. The function switches with the unit status. Such as, set the cursor position, body mark position, comment position, toggle trackball function, selected the menu, and confirm the input.
UPDATE
This multifunctional key is work with trackball. The function switches with the unit status. Such as, call the annotation and back in measuring.
EXIT
Press this key can exit measurement, dialog, and menu.
CURSOR
Press this key to show or hide the cursor.
CLEAR
Press this key to clear all the measurement lines, body mark, and annotations.
MENU
Press the MENU knob for second time to select the item and adjust the parameters. Press this knob for third time to exit from current item. Rotate the MENU knob to select the item.
DIST
Press this key to enter into distance measurement.
TRACE
Press this key to enter into trace measurement.
CALC
Press this key to enter into measurement software package.
Trackball
Trackball is the main operation tool on screen. Position calipers in measurement, the function of the trackball is different under diverse working status.
6.DIST 7.TRACE 8.CALC 9.ENTER 10.Trackball
4.5 Information Area Indicating Machine Status
Left-to-Right of the up row: hard disk, cable network, USB
Hard disk: press this icon to show the capacity of disc has been used to save data or USB flash disk in current system. Cable network: show the present situation of cable network; press this icon to show the IP address of current system. USB: show whether this system connects USB flash disk or not, press this icon to show USB safely remove interface.
Left-to-Right of the down row: input method, task queue, power
Input method: press this icon to switch between uppercase and lowercase characters. Task queue: press this icon to show task and its situation. To terminate the task, delete, and so
on. Power: show the connecting situation of the power.
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Chapter 5 Operation and Exam Mode
This chapter mainly describes the process of the normal operation of the device, including the preparation before examination, how to get the image, optimize the image, add comments, body mark and so on.
5.1 Preparing the System for Use
5.1.1 The Device Inspection
1. The device is placed stability.
2. The grid voltage AC 100-240V, 50-60Hz.
3. Cable is properly connected, firm and ground, the adapter is properly connected to the device.
4. Probe is connected and fixed.
5.1.2 Start the system
Press to start the system, wait for the system to enter into the user interface and activate the probe into the B mode.
5.2 Choose Exam Mode
5.2.1 The Probe Identification
The system default automatically identifies the current probe type, when the probe is inserted,
Press to switch the probe.
CAUTION: Please connect or disconnect the probe only after the system is freezing, in
order to ensure stability and extend the service life of the probe.
5.2.2 Mode Selection
In probe selection interface, probe and clinical application selection page is displayed, you can choose needed probe and inspection part, and press an application preset into the B mode, start scan detection.
NOTE: The system has been set clinical application preset before leaving factory, each
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probe has its own presets.
The detailed operation steps of the clinical application preset for the probe please refer to the exam mode part of preset section.
5.3 Patient Data Entry
Press to display the patient screen.
Function Buttons on Patient screen:
Archive: Operation on the patient information which has already existed. Worklist: Recall patient information in worklist. And need to activate the DICOM function. New Patient: Create a new patient information identity. New Study: Choose exam applications (OB, GYN, CARD and so on) for the current patient. End Study: End the current patient’s exam item. OK: Save patient information. Cancel: Cancel the operation of new patient information. Operation Methods:
1. Move the Trackball to the position of inputting character, and then input patient information by character keyboard.
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2. Use the Trackball and the [ENTER] key to switch between different input options: ID, patient name, doctor's name, birthday (It can be automatically calculated when input age), age (It can be automatically calculated when input birthday), gender.
3. Select the exam items, and input the regular inspection information.
4. After inputting the required information, click on the [OK] button to save the patient information, the system will return to the B mode.
5. Recall information of the previous patient, you can use the Archive or Worklist to recall patient information to exam.
CAUTION: Creating a diagnostic record, you should check the accuracy of the patient
information before saving measurement or image; otherwise, it will be stored in the wrong patient
records. After checking the patient, press to save the patient information in the system.
5.4 Image Interface Display
1, Logo 2, Control menu 3, Image status prompt 4, Image parameter area
5, System state prompt 6, Image parameter area 7, Gray-scale strip
8, Start point of scanning 9, Image Region 10, Cine loop
5.5 Image Mode
5.5.1 B Mode
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Press [B] key, and display the single B Mode image, B Mode is the basic mode for two-dimensional scanning and diagnosis.
5.5.2 2B Mode
Press or key to display double B mode images side by side. One image is in real-time status; the other is in frozen status. The real-time image has start scan marker and ruler
marker .Press key in 2B mode, the original active image is frozen while the original frozen image is activated.
In frozen status, Press to choose a B mode image to be activated when unfreezes the image.
5.5.3 4B Mode
Press key to enter into 4B mode, the screen will display four B mode images side by side, but only one image is in real-time status. Pressing it again can switch the real-time status among
four images.
In frozen status, Press to choose a B mode image to be activated when unfreezes the image.
5.5.4 B/M Mode
Press [M] key, a real time B mode image and a real-time M-mode image will be displayed at the same time. And a sample line will appear in the B mode image area, which indicates the active sample position for M image on the B image area. Move the sampling line by trackball.
5.5.5 M Mode
Press [M] key again, B mode image will disappear; M mode image is still active on the whole screen. M mode image stands for the tissue movement status at the sampling line. The M mode image varies with time, so it is mainly used for cardiac applications.
5.5.6 CFM Mode
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CFM is a Doppler mode intended to add color-coded qualitative information concerning the relative velocity and direction of fluid motion within the B mode image.
CFM is useful to see flow in a broad area. It allows visualization of flow in the CROI, whereas Doppler mode provides spectral information in a smaller area. CFM is also used a stepping stone to Doppler mode. You can use CFM to locate flow and vessels prior to activating Doppler.
In CFM mode, move the trackball to change the position of sampling box. Activate the [STEER] knob and rotate the knob to adjust the angle of color sampling box (if current probe is linear probe). Press [ENTER] key to set the position of color sampling box. At this time adjusts the size of color sampling box through moving trackball. Press [ENTER] key again and move trackball to change the color sampling position again.
Press [C] key to enter into CFM mode; after [C] key light is on, rotate the [GAIN] knob for adjusting the gain of CFM.
CFM mode Exam Procedure:
Follow the same procedure as described under B mode to locate the anatomical area of interest.
After optimizing the B mode image, add Color Flow. Move the color region of interest CROI as close to the center of the image as possible. Optimize the color flow parameters so that a high frame rate can be achieved and appropriate
flow velocity can be visualized.
Press [FREEZE] key to hold the image in cine memory. Record color flow image as necessary.
CFM Scanning Hints: PRF: increase/decrease the PRF on the color bar. Imaging of higher velocity flow requires
increased velocity scale values to avoid aliasing
Wall Filter: affect low flow sensitivity versus motion artifact Color Map: allow you to select a specific color map. It shows the direction of the flow and
highlights the higher velocity flows. Color Gain: amplify the overall strength of echoes processed in the CROI
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Persistence: affect temporal smoothing and color Doppler ‘robustness’.
5.5.7 B/BC Mode
In active color mode, turn the [B/BC] item on to display a real B mode image at the right side of the screen and active Color mode image at the left side of the screen.
5.5.8 CPA (PD) Mode
Power Doppler Imaging (PD) is a color flow mapping technique used to map the strength of the Doppler signal coming from the flow rather than the frequency shift of the signal. Using this technique, the ultrasound system plots color flow based on the number of reflectors that are moving, regardless of their velocity. PD does not map velocity; therefore it is not subject to aliasing.
Press [CPA] key to enter into the CPA (PD) mode.
Direction PD mode
In Power Doppler (CPA) mode, press [MENU] knob to pop up the PD Menu. Rotate [MENU] knob to select the DPD Mode and press [MENU] knob to enter into DPD mode. If you need go back to PD mode from DPD mode, you could press [CPA] key or select the PD mode item in the DPD mode.
5.5.9 PW Mode
Doppler is intended to provide measurement data concerning the velocity of moving tissues and fluids. PW Doppler lets you examine blood flow data selectively from a small region called the Sample Volume. The X axis represents time while the Y axis represents velocity in either a forward or reverse direction. PW Doppler is typically used for displaying the speed, direction, and spectral content of blood flow at selected anatomical sites.
PW Doppler can be combined with B mode for quick selection of the anatomical site for PW Doppler examination. The site where PW Doppler data is derived appears graphically on the B mode image (Sample Volume Gate). The Sample Volume Gate can be moved anywhere within B
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mode image.
PW mode Exam Procedure:
Get a good B mode image. Press [C] key to help locate the vessel you wish to examine. Press [D] key to display the sample volume cursor and gate. Position the sample volume cursor by moving the Trackball left and right. Position or re-size the
sample volume gate by moving the Trackball up and down, then press [ENTER] key. Press [UPDATE] key to display PW Doppler spectrum and the system will run in combined B+Doppler mode. The Doppler signal can be heard through the speakers.
Optimize the PW Doppler spectrum as necessary. Ensure that the sample line is parallel to the blood flow.
Press to hold the trace in cine memory and stop imaging. Perform measurements and calculations, as necessary.
Record results with your recording devices.
Press to resume imaging. Repeat the above procedure until all relevant flow sites have been examined.
Replace the probe in its respective holder.
When entering Duplex mode for the first time, the Doppler spectrum is not activated. The Doppler Sample Volume appears in the default position, and the B mode image or 2D (either B or Color) mode are active. Moving the Trackball will change the Sample Volume position. Press the [ENTER] key to toggle the Trackball function between Sample Volume Gate position and size. Press the [UPDATE] key after the Sample Volume Gate is defined to activate the Spectral Doppler mode. Press the [UPDATE] key for second time to toggle back to 2D (B or Color) update and deactivate the Spectral Doppler.
Doppler Sample Volume Gate Position and Size (Trackball and ENTER)
Move the sample volume on the B mode’s Doppler cursor. The gate is positioned over a specific
position within the vessel.
To move Doppler cursor position, turn the trackball left or right until positioned over the vessel. To move sample volume gate position, move the trackball up or down until positioned inside the
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vessel. To size sample volume gate, press [ENTER] key to toggle trackball function from sample volume gate positioning to sizing, then move the trackball to change sample volume gate size.
5.5.10 CW Mode
Continuous Wave Doppler allows examination of blood flow data all along the Doppler cursor rather than from any specific depth. Gather samples along the entire Doppler beam for rapid scanning of the heart. Range gated CW allows information to be gathered at higher velocities. It works with a phased array or pediatric probe. If the velocity of the blood flow is even too high for the HPRF mode to detect, you have to try CW mode. Press [CW] key to enter CW mode when the probe supports CW mode.
5.5.11 TDI Mode
TDI mode is tissue Doppler mode, which is intended to provide information of low-velocity tissue motion, specifically for cardiac movement. Only phased array probe is available for TDI function.
5.5.12 Color M Mode
Color M mode is used for fetal cardiac applications. Color flow overlays color on the M mode image using velocity and variance color maps. The color flow wedge overlays the B mode image and M mode timeline. The color flow maps available in M mode are the same as in CFM mode. Color M mode is a Doppler mode intended to add color coded qualitative information concerning the relative velocity and direction of fluid motion within the M mode image. If the system is in color mode and the probe supports Color M mode (e.g. phased array probe), press [M] key to enter Color M mode.
5.5.13 2D Steer
2D Steer is available for linear probes. It can steer the beam to obtain the left or right image and enlarge the area without to rotate the probes. In B mode, press menu knob to pop up B Menu, adjust 2D Steer item to change 2D steer angle.
5.5.14 Trapezoidal Mode
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Trapezoidal image is available for linear probes. In B mode, press menu knob to pop up B Menu, turn Trapezoidal Mode menu on to enter to Trapezoidal Mode.
5.5.15 ECG
The ECG module is a device that provides the 3 lead ECG signal acquisition for cardiac application. It is not intent for the ECG diagnostic purpose as in the 12-lead module. In the cardiac application, the ECG trace is displayed on the bottom of the screen. For echo-stress, the R-wave triggering is used to gate or synchronize the image acquisition. The ECG has 3 leads: LL (left leg, RED), LA (left arm, BLACK), RA (right arm, WHITE). LA is for reference, which usually provides a bias voltage from the ECG module, and the LL, LA are the two signals from the body and going to the differential input of the ECG isolation amplifier.
5.5.16 HD 3D
Before using the HD 3D function, connect the 3D module and the ultrasonic device with a network cable.
Operation Procedure:
a. In B mode, press the [Freeze] key to enter the frozen status. Rotate the corresponding parameter knob of [3D ROI] to turn on the 3D ROI. System will display the ROI box. b. Press the [ENTER] key , the ROI box changes to the dotted line and move the trackball to adjust the size of the ROI box. Then press [ENTER] key again to confirm the size. c. Move the trackball to drag the ROI box to the target area, and press the [UPDATE] key to confirm the location. d. Then move the trackball and press the [ENTER] key to choose the start pos and end pos of the designated image. e. Press the parameter knob of [HD 3D] to enter the HD 3D mode. The system will display the rebuilt 3D image. Rotate the [C], [D] or [M] key on the control panel, the 3D image will spin around X axis, Y axis and Z axis. You can press the [ANGLE_ZOOM] knob to reset. f. Rotate the parameter knob of [Vol Spacing] to set the physical distance of each frame of image movement. g. After finishing these operation, you can press [Freeze] key or [B] knob to go back to the real B mode. Or press [Exit] key to go back to the frozen B mode.
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Menu &
Parameters
Function description
Keyboard Keys
Gain
In real status, rotate [B] knob to adjust the Gain.
STC
STC curves can be used for adjusting gain compensation in different image depth. Drag the slide of STC to adjust the value. STC curve will disappear automatically 1 second later after stopping adjustment.
Depth
Press [DEPTH_FOCUS] knob until the indicator of [DEPTH] is lit, and then rotate the knob to change the depth of image.
Focus
Press [DEPTH_FOCUS] knob until the indicator of [FOCUS] is lit, and then rotate the knob to change the focus position.
Zoom
Press [ANGLE_ZOOM] knob to appear the zoom box, press [UPDATE] key and move trackball or rotate the [ANGLE_ZOOM] knob to change the zoom ratio.
Tips: User also can operate 3D mode directly according to the step d to g, without adjusting
ROI box.
5.5.17 Biopsy and Super Needle
1. How to enter into Biopsy Activate the [Biopsy] and press the [MENU] knob to show or hide biopsy line.
2. How to adjust the biopsy After the biopsy line shows, press the [ENTER] key to activate the adjustment function of biopsy line, horizontal rolling the trackball can translate the biopsy line, vertical rolling the trackball can adjust the line angle, press the [UPDATE] key to set the default biopsy line position.
3. Super Needle Super needle is used for enhance the needle image in the B mode image. After turning on the super needle, super needle and needle angle function will be active and user can adjust the needle angle to optimize the image for needle only (The angle is 5 degree per step.).
5.6 B Image Menu & Parameters
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Menu &
Parameters
Function description
Invert
B mode image and B/M mode image can be reversed horizontally and vertically.
Press , the displayed image is reversed in the up-down direction. The horizontal flip status indicators of the upper-left corner of the image
window have the following meanings:
The meaning of the symbol “ ” indicating the probe initiative scanning
position “ ” situated in the left indicates that the first scanning line in the left of
the screen is corresponding to the initiative scanning position of the probe, “
situated in the right indicates that the first scanning line in the right of the screen is corresponding to the initiative scanning position of the probe.
FHI
Press to turn on or off FHI function.
AIO
Press to activate the AIO function.
Full Screen Show
Full screen the image area. Press to activate the function;
Press , [EXIT] or again to exit full screen show. When full screen shows, press [MENU] knob to show the menu of current
mode (except bodymark, annotation, measurement).
Bottom Menu
Freq
In real status, rotate the corresponding knob of [Freq] to adjust the frequency.
Dynamic
Dynamic range is used for adjusting the contrast resolution of B mode image and mode image, compressing or enlarging the display range of gray scale. At the real-time status, rotate the corresponding knob of [Dynamic] to adjust dynamic.
Focus Num
In B mode, 9 focus points can be selected simultaneously, and the number controlled by the depth, SRA and Compound. Rotate the corresponding knob of [Focus Num] to adjust.
Focus Pos.
Rotate the corresponding knob to change Focus Position.
Compound
In real status, rotate the corresponding knob of [Compound] to turn it on or off. The SRA can’t be edited after opening the compound.
SRA
In real status, rotate the corresponding knob of [SRA] to turn it on or off.
Q-Image
In real status, rotate the corresponding knob of [Q-Image] to adjust.
Persistence
In real status, adjust the contrast and resolution. In real status, rotate the corresponding knob of [Persistence] to adjust.
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Menu &
Parameters
Function description
Density
Scan Line Density function is only valid for the image in B mode, 2B mode, B/M mode or 4B mode image. The line density has two types: high density and low density. High density means better image quality while low density image has higher frame rate. Rotate the corresponding knob of [Density] adjust the line density.
B Rejection
Adjust image gray scale inhibition parameters. Activate [B Rejection], and rotate [MENU] knob to adjust B Rejection parameters.
Left Menu
Scan Width
Rotate the corresponding knob of [Scan Width] to adjust the scan width of the corresponding size.
Smooth
Smoothness function is used for restraining the image noise and performing axial smooth processing to make the image smoother. Rotate the corresponding knob of [Smooth] to adjust.
Edge Enhance
Edge enhancement is used for enhancing the image outline. In this way the user can view the tissue structure more clearly. Rotate the corresponding knob of [Edge Enhance] to adjust.
A Power
Acoustic power means the acoustic power transmitting from the probe. Rotate the corresponding knob of [A power] to adjust.
L/R Flip
Activate the [L/R Flip] and press the [MENU] knob to invert the image from left and right.
Menus of Advance
Zoom Coef
Adjust the size of ruler & image. Rotate the corresponding knob of [Zoom Coef] to adjust.
Trapezoidal Mode
Activate the [Trapezoidal Mode] and press the [MENU] knob to turn on or off the trapezoidal function.
2D Steer
Activate the [2D Steer] and press the [MENU] knob to turn on or off the 2D Steer function.
ECG
Activate the [ECG] and press the [MENU] knob to turn on or off the ECG function.
UD Invert
Activate the [UD Invert] and press the [MENU] knob to turn on/off the ECG invert.
ECG GAIN
Activate the [ECG GAIN] and rotate the [MENU] knob to increase or decrease the ECG gain.
ECG POS
Activate the [ECG POS] and rotate the [MENU] knob to set the ECG trace position.
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Menu &
Parameters
Function description
ECG Velocity
Activate the [ECG Velocity] and rotate the [MENU] knob to set the ECG Velocity.
ECG Dyn
Activate the [ECG Dyn] and rotate the [MENU] knob to set the ECG dynamic.
Biopsy
Show or hide biopsy. Activate the [Biopsy] and press the [MENU] knob to show or hide biopsy line. After the biopsy line shows, press the [ENTER] key to activate the adjustment function of biopsy line, horizontal rolling the trackball can translate the biopsy line, vertical rolling the trackball can adjust the line angle, press the [UPDATE] key to set the default biopsy line position.
Super Needle
Activate the [Super Needle] and press the [MENU] knob to turn on or off the Super Needle function.
Needle Angle
Activate the [Needle Angle] and rotate the [MENU] knob to set the needle angle.
Center Line
Show or hide Center Line. Press the [MENU] knob to show or hide center line.
Menu & Parameters
Function description
Post Process
Chroma:Adjust the type of the chroma.
2D Map:Select the type of the scale curve.
Gamma:Adjust image gray value parameters.
B Rejection:Adjust image gray scale inhibition parameters
Slide Show
Activate the [Slide Show] to enter into slide show mode.
Menu &
Parameters
Function description
Keyboard Keys
Refer to B image adjustment for keyboard keys.
Bottom Menu
Speed
Rotate the corresponding knob of [Speed] to adjust M speed.
M Chroma
Rotate the corresponding knob of [M Chroma] to select the Chroma type.
Layout
Rotate the corresponding knob of [Layout] to select the layout of B/M image.
Left Menu
5.6.1 Utility Menu
This function includes post processing, slide show and other items. Press [MENU] knob, then choose Utility selection, it will appear Utility options.
5.7 M Image Menu & Parameters
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Menu &
Parameters
Function description
M 2D Map
Rotate the corresponding knob of [M 2D Map] knob to select the scale curve
type.
Menu &
Parameters
Function description
Keyboard Keys
Refer to B image adjustment for keyboard keys.
Bottom Menu
Freq
In real status, rotate the corresponding knob of [Freq] to adjust the frequency.
Steer
Press [ANGLE_ZOOM] selection knob until the indicator of [ANGLE] is lit, and then rotate the knob to change the steer of linear image ROI. Or rotate the corresponding knob of [Steer] to change the steer of linear image ROI.
Wall Filter
Rotate the corresponding knob of [Wall Filter] to adjust wall filter.
Color Map
Rotate the corresponding knob of [Color Map] knob to select the color type. (CFM mode only)
Q-flow
Press to turn on or off the Q-flow function.
PRF
Rotate the corresponding knob of [PRF] to Adjust PRF, adjustment range depends on probe.
Color Invert
Press the corresponding knob of [Color Invert] to invert the color of flow.
Persistence
Rotate the corresponding knob of [Persistence] to adjust.
Q-beam
Press to turn on or off the Q-beam function.
Base Line
Adjust the position of baseline. Rotate the corresponding knob of [Baseline] to change position of baseline.
Left Menu
CF Mode
Press [MENU] knob on [CF Mode] item to adjust CF mode, velocity or variance.
Wall Thre.
Activate [Wall Thre.], and rotate [MENU] knob to adjust wall thre.
Blood Effection
Activate [Blood Effection], and rotate [MENU] knob to adjust blood effection, smooth or resolution.
Density
Press the corresponding knob of [Density] to adjust the line density, high or low.
B/BC
Press [MENU] knob on [B/BC] item to enter into or quit the B/BC mode.
5.8 CFM/CPA/DPD/TDI Image Menu & Parameters
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Menu &
Parameters
Function description
Keyboard Keys
Refer to B image adjustment for keyboard keys.
Steer
When the indicator of [ANGLE] is lit, rotate [ANGLE_ZOOM] knob to change the steer of linear image ROI. Or rotate the corresponding knob of [Steer] to change the steer of linear image ROI.
Bottom Menu
Freq
In real status, rotate the corresponding knob of [Freq] to adjust the frequency.
PW/CWD Chroma
Rotate the corresponding knob of [Chroma] to select the Chroma type.
Speed
Rotate the corresponding knob of [Speed] to adjust PW speed.
Audio
Adjust audio volume.
Rotate the corresponding knob of [Audio] or press & to adjust audio volume, adjustment range from 0~100%.
Triplex Mode
Press the corresponding knob of [Triplex Mode] to turn on or off triplex mode.
PRF
Rotate the corresponding knob of [PRF] to Adjust PRF, adjustment range depends on probe.
Base Line
Adjust the position of baseline. Rotate the corresponding knob of [Baseline] to change position of baseline.
Left Menu
D/CW 2D Map
Activate [2D Map] and rotate [MENU] knob to select the 2D map.
Spectrum Enhance
Activate [Spectrum Enhance] and rotate [MENU] knob to adjust spectrum enhance.
Dynamic Range
Activate [Dynamic Range] and rotate [MENU] knob to adjust dynamic range.
5.9 PW/CW Image Menu & Parameters
5.10 Image and Cine Disposition
5.10.1 The Principle of Cine Storage
In real image status, the image can be stored in the movie memory in chronological order, maximum frames can be set. The maximum number of frames of the film storage can be set, please refer to preset chapter. If the movie memory is full, the recent frame saved into memory, the previous frame removed from memory.
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Cine loop indicate diagram
5.10.2 Manual Loop
Press to freeze image, pop cine playback bar, at this time, move trackball to play by hand.
5.10.3 Automatic Loop
After freezing image, press [Play/Pause] to play, press it again to stop. Press [ENTER] key to choose the area of automatic playback area needed.
5.10.4 Loop Range Set
Rotate the corresponding knob of [Start Pos] and [End Pos] to set the loop start position and end position, the loop range settled. Rotate the corresponding knob of [Reset Ranges] to reset the loop range to maximum.
5.10.5 Save and Recall Image
Press to save current image, the image will be displayed below the screen. If you need to recall images that have been stored, move cursor to needed image, press [ENTER]
key to recall it; or you can recall archived patient’s information to recall image, please refer to archive chapter.
5.10.6 Save and Recall Cine
In freeze status, press to save cine, then it will be displayed below the screen, move cursor to needed cine, press [ENTER] key to recall cine.
5.10.7 Send image
After recalling the images, press the corresponding knob of [Send] to send images to USB flash
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disk, net storage, DICOM storage and print. Hint1: Activate the DICOM before DICOM storage and print. Hint2: Click the “Cine transform to AVI” to save the cine to AVI.
Sending Interface
5.11 Edit Comment
5.11.1 Overview
The comment is to enter text or symbols on the image.
Enter COMMENT: Press or enter into comments status; or input characters with alphanumeric keyboard, the system will enter into comments status too.
Exit COMMENT: Press or again or [EXIT], to exit. Comment means input the words or symbols on images for making explanation. Add comments
can through keyboard input directly or using the default comments. The default comments are classified by examination mode as follows:
NOTE: If you need to custom the default comments, refer to the preset section.
5.11.2 Input Characters
Operation:
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1. Press or , then system will go into the comment process; or input characters with alphanumeric keyboard, the system will enter into comments status too.
2. Move the cursor to the position where need to comments.
3. Input characters at cursor position by keyboard then press [ENTER] key to confirm.
4. Press or again or [EXIT], to exit.
5.11.3 Input Comment Library Characters
1. In comment status, move trackball to image area to edit.
2. Rotate the corresponding knob of [Font size] to adjust front size of comments, the range is 10~20.
3. Rotate [MENU] knob to select needed comments, then press [MENU] knob to exit.
5.11.4 Edit Quick Comments
1. Rotate the corresponding knob of [Edit] to pop quick comment edit box.
2. Input customized comments.
3. Press [Done] to finish edit, press [X] to cancel edit.
5.11.5 Input Quick Comments
1. Press [Text] to select needed quick comments.
2. Adjust front size of comments.
3. Press the corresponding knob of [Input] to place comments in the image area.
5.11.6 Move Comments
1. In comment status, move trackball to the comment, press [ENTER] key to activate it.
2. Move trackball to place the comment to target area.
3. Press [ENTER] key again to confirm the comment.
5.11.7 Edit Comments
1. In comment status, move trackball to the comment, press [ENTER] key to activate it.
2. Press [BackSpace] key to delete unnecessary characters.
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3. Press [ENTER] key to confirm.
5.11.8 Delete Comments
5.11.8.1 Delete Characters
In comment status, activate the comment that need to be deleted, then press the [ENTER] key, it will display "|" on the screen, press [BackSpace] key to delete the character.
5.11.8.2 Delete Single Comment
Activate the comment that needs to be deleted, press to delete comment.
5.11.8.3 Delete All Contents of the Comment
Don’t activate the single comment, and then press to delete all characters that has input.
CAUTION: Press will delete the measurement and body mark at the same time.
5.11.9 Set the Position of Default Comment
Operation:
1.Press the corresponding knob of [Save Home Pos.] to move cursor to the initial position.
2.Press the corresponding knob of [Load Home Pos.] to set the initial position .
5.12 Set Body Mark
5.12.1 General Description
The body mark indicates patient’s examination position and the direction of probe scan on the image. Body marks are divided into: obstetric, abdomen, gynecology, heart and small parts, each has different body mark. Each type of body mark automatically is corresponding to current examination mode.
5.12.2 Body Mark Operation
Operation:
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1. Press or to enter into the body status.
2. Select the body mark that you need.
3. Move trackball after adding the body mark image and then adjust the position of probe. Rotate
[MENU] or [ANGLE] knob can adjust the probe direction. Press [ENTER] key to confirm when adjustment was finished.
4. Move the Trackball to change the position of the body mark.
5. If you want to exit from the body mark function, press or again or [EXIT],
to exit; and the body mark is fastened to the screen.
6. Press or to delete the body mark.
5.13 Set the Direction of Arrow
Operation:
1. Press or to display arrow.
2. Press to select cursor type: arrow or cross.
3. Rotate the corresponding knob of [Size] to change the size of the cursor.
4. Rotate [MENU] or [ANGLE] knob can adjust the arrow direction.
5. Press [ENTER] key to confirm when adjustment was finished.
6. Press [EXIT] key or to exit the arrow settings.
7. Press to delete the arrows one by one.
8. Press to clear all the arrows inputted.
5.14 Image Browse
Press to enter image information browsing interface. Press [ENTER] key on an item to
activate the item’s function.
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ID: ID of Current patient. Name: Current patient’s name. Information: Enter into current patient’s information interface. Report: Enter into current patient’s report interface. Send images: Send image to USB disk , DICOM storage and print. Print images: print the image which be chosen, it will be printed as the arrangement set. Delete images: Delete selected image. Row*Column: Select image’s format. Pre page: Page up. Next page: Page back. Select All: Select all the images of this patient. Deselect All: Deselect all the images of this patient. New Exam: Exit current examination and open a new dialog box. Continue Exam: Exit image browsing interface and go on checking current patient. Archive: Open up archive management interface. Exit: Turn off image browsing interface.
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5.15 Archive Management
Archive management can search for patient’s information which has been stored in system. Press
[Archive] to archive management interface, all process can be opened up by moving cursor.
Item: Type selection, select Patient’s ID or Name. Keyword: Search for key words. Period: Time filter, select today, one week, one month, three months, six months, recent one
year and all.
Multiple Choice: Multiple choice. Data Source: Path choice, select hard disk or U disk. Patient info: Enter into patient’s information interface. Review Report: Enter into report interface. Backup Exam: Select examination information to USB hard disk. Restore Exam: Recover examination information from USB hard disk. Send Exam: Send selected examination information remotely to USB hard disk or DICOM
Storage/Print (Need to activate the DICOM).
Delete Exam: Delete selected examination information. Patient View: Change display mode of information.
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Expand All: Select Patient View, it will display sub-directory. Collapse All: Exit sub-directory. Select All: Select all examination information. New Exam: Exit current patient’s examination. Continue Exam: Exit archive management interface and go on checking current patient. Easy View: Exit archive management interface and open up image browsing interface. Exit: Exit archive management interface and go on checking current patient.
5.16 Report
Move cursor to the images and press [ENTER] key to add the image into the report page. The
report can be saved and printed. It is convenient for the doctor to view and edit the patient’s
information. Reports contain normal report, abdominal report, cardiac report, small part report etc. Move the cursor to the required report page and press [ENTER] key to choose.
Press and the system pop up the report page of the current exam mode. Change the other exam mode report by the drop-down box.
Report Title: Report options, different kinds of report can choose, such as Normal, OB/GYN
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etc.
Hosp: Display the hospital name. Abdomen Report: Display the kind of report. Patient Name: Display the patient name. Age: Display the patient age. Sex: Display the patient sex. Patient ID: Display the patient ID Diagnostic: Input the diagnostic instructions. Description: Input the description of symptom. Tips: Input note information. Clear All: Clear all the data including the selected images the measurement result and patient’s
information etc.
Print: Print the report with image. Export: Export the PDF report to the U disk. Save: Save the report in system. The image on the right side: Press [ENTER] key on the image to add the image into the
report.
 Select All: Select all the images of the image on the right side.  Deselect All: Cancel to select all the images of the image on the right side.
5.17 DICOM
5.17.1 DICOM Worklist
Press [Worklist] button in Patient Interface, pop up the following dialog box
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Name: input ID or some characters , fuzzy query needs server. Search By: select term , ID or name.
ID: display the ID of patients. Name: display the names of patients.
BirthDate: display the birth date of patients. Sex: display sex of patients. Doctor: display names of doctors. Acc#: display the accession number of patients. Update: press this button to do search operation. Apply: select the searched patient and press this button , input all patient information into the
new patient interface.
Clear: clear all searched content.
5.17.2 DICOM Storage
Check the “Send while saving” in setting, then DICOM storage when saving cine and images.
Press send button in archive or freeze interface. DICOM Send interface as follows:
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Select DICOM Storage in left, choose DICOM server and press Export button to DICOM storage. Enter Task Queue and watch or edit DICOM process.
5.17.3 DICOM Print
DICOM Print operation is the same as DICOM storage.
5.17.4 DICOM SR
Press [Send DICOM SR] button in report interface, this task is added into Task Queue.
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Chapter 6 Measurement and Calculation
Main content of this chapter: Normal calculation and measurement on B mode image and M mode image, OB calculation and Urology measurement etc., system can enter into corresponding measurement mode depend on current exam mode, and enter into the corresponding report depend on the measurement mode. System has built-in the default measurement according to the exam mode, the change of measurement please refers to the chapter of preset settings.
CAUTION: Please select the most appropriate ultrasound images, measurement tools
and measurement methods for measurements according to your diagnosis needs. The final measurement results must be determined and verified by a physician. Measurement accuracies are affected by many non-technical factors, for example operator’s experience, patient’s status. Please do not only use the ultrasound measurement results as the sole basis for diagnosis, please always use other clinical information to do integrated diagnostics.
6.1 Keyboard for Measurement
6.1.1 Trackball
Trackball is used to move the cursor, main functions are as follows:
1. Before starting a measurement, use the trackball to choose the menu options.
2. After starting a measurement, move the trackball to move the cursor, during the measurement,
the cursor should not be moved out image area.
3. During the Ellipse method measurement, use trackball to change the length of short axis.
4. Update the moving of the measurement result, move the trackball to change the position of the
measurement result.
6.1.2 [ENTER] key
During the measurement, the functions of [ENTER] key are as follows:
1. When cursor is on the menu, press the key to choose the options and start the measurement.
2. During the measurement, press the key to anchor the start point and end point.
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6.1.3 [UPDATE] key
1. Before the measurement, press [UPDATE] key to change the measurement method, such as
ellipse, trace. The changeable measurement item has “< >”.
2. During the measurement, [UPDATE] key is used to switch the start point and end point, long
axis and short axis when the measurement is not finished.
3. During the distance measurement, press [ENTER] key to fix the start point, when the end point
is not fixed, press [UPDATE] key to switch the start point and end point.
4. During the Ellipse measurement, when fix the long axis, but the short axis is not fixed, press
[UPDATE] key to switch the long axis and short one.
6.1.4 [CLEAR] key
Press to delete all the measurement results, comments and traces.
6.1.5 [Del] key
Press to roll back the measurements step by step.
6.1.6 [CHANGE] key
Press to switch other menu.
Press [EXIT] key or to exit.
6.1.7 [Exit] key
Press [EXIT] key or to exit the measurement menu.
6.1.8 Parameters control key
Press the corresponding key to update the function and use the function.
6.2 B Mode General Measurement Methods
The system B mode contains Distance, Ellipse, and Trace.
6.2.1 Meas. Distance
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Measurement steps:
1. Press the [CALC] key to enter into measurement. Update the [distance] item in the menu or
press the quick measure key [DIST], it will display a segment “+”icon.
2. Move the “+”icon by trackball to fit the one point of the line. Press [ENTER] key to fix the start
point and the cursor can be moved to the next position.
3. Press [UPDATE] key can change the activated point, and fit the other point of the line.
4. Move the cursor to the end-point, press [ENTER] key again to complete the measurement.
5. After the measurement, the result will display in the measurement results area.
6. Repeat the steps from 1 to 4 to start next “distance” measurement.
NOTE:
Each group of measurement is limited, if the measurement results beyond, it will begin a new group of measurement automatically.
6.2.2 Ellipse
Measurement steps:
1. Press the [CALC] key to enter into measurement. Update the [Ellipse] item on the menu; it will
display a segment “+”icon.
2. Move the “+”icon by cursor, Press [ENTER] key to fix the point and the cursor can be moved to
form a round.
3. Press [UPDATE] key can exchange the activated point and the fixed point.
4. Move the cursor to the end-point of the ellipse, press [ENTER] key to fix the axis, at the same
time, the next axis be updated, and can change the size of the axis by the cursor.
5. Now press [UPDATE] key can exit to the step 4.
6. After fixing the next axis, can press [ENTER] key to complete the measurement.
7. After the measurement, the result will display in the measurement results area.
8. Repeat the steps from 1 to 6 to start next “ellipse” measurement.
NOTE:
Each group of measurement is limited, if the measurement results beyond, it will begin a new group of measurement automatically.
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6.2.3 Trace
Measurement steps:
1. Press the [CALC] key to enter into measurement. Update the [Trace] item in the menu or press
the quick measure key [TRACE], it will display a segment “+”icon.
2. Move the “+”icon by cursor, Press [ENTER] key to fix the point and the cursor can be moved to
the next position.
3. Make the cursor tracing along the edge of required area, the traced line can be not closed.
4. Now press [UPDATE] key to cancel the tracing.
5. Press [ENTER] key again in the endpoint, the start point and end point of trace line will be
closed by a straight line.
6. After the measurement, the result will display in the measurement results area.
7. Repeat the steps from 1 to 5 to start next “trace” measurement.
NOTE:
Each group of measurement is limited, if the measurement results beyond, it will begin a new group of measurement automatically.
6.2.4 Histogram
Histogram is used to calculate the gray distribution of the ultrasound echo signals within a specified area. Use the rectangle, ellipse or trace method to draw along the desired measurement area. The result is shown in the form of histogram. Histogram can be measured only on the frozen image.
Measurement steps by rectangular method:
1. Press to freeze the image.
2. Press [ENTER] key on [Histogram] menu to enter into measurement status.
3. Press [ENTER] key to fix one apex of the rectangle.
4. Move the trackball to change the cursor position and fix the diagonal point of the rectangle
5. Move the trackball to change the cursor position, fix the diagonal point of the rectangle, and
press [ENTER] key again to confirm the measurement area. The result will display on the measurement result area.
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Measure the histogram by ellipse or trace method: The method is the same as that to measure
ellipse or trace method, press [UPDATE] key to change the measurement between ellipse and trace. The horizontal axis represents the gray scale of the image ranging from 0 to 255. The vertical axis represents the distribution ratio of each gray scale. The value shown on the top of vertical axis represents the percentage of the maximally distributed gray in the whole gray distribution.
6.2.5 Profile
Profile is used to measure the gray distribution of the ultrasound signals in the vertical or horizontal direction on a certain profile (section). This measurement is only available in the frozen mode. Measurement steps:
1. Press to freeze the image.
2. Press [CALC] key, and choose [B General Meas.].
3. Draw a straight line at the measuring position. The method is the same as that to measure distance.
4. The calculated result of the profile will be displayed at the center of the screen.
1-The horizontal (or vertical) axis represents the projection of the profile line on the horizontal direction. 2-The vertical (or horizontal) axis represents the gray distribution of the corresponding points on the profile line. The range is 0 to 255.
6.2.6 Volume of A4CTrace method
A4CTrace tool is used to measure the cardiology item, Single Plane, Simpson BP etc.. These measurements are used to calculate the volumes.
Measurement steps:
1. Press to freeze the image.
2. Press [CALC] key, and choose [Cardiology]. Activate an A4CTrace measurement such as
Single Plane-EDV.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Distance
Distance
cm
Refer to Distance Meas.
Ratio(Distance)
Refer to Distance Meas. Formula: R=D1/D2
D1: First Distance D2: Second Distance
Angle
deg
Refer to Distance Meas.
Angle Range: 0°~ 180°
Area Perimeter/Area
Area:cm2 Perimeter: cm
Refer to Ellipse and trace meas.
Ellipse and trace.
Ratio(Area)
Refer to ellipse Meas. Formula: R=A1/A2
A1: First Area A2: Second Area
Volume
Volume(1Distance)
ml
Refer to Distance Meas. Formula:
V=(π/6)*D
3
D means: Depth
Volume(1Ellipse)
ml
Refer to ellipse meas. Formula:
V=(π/6)*A*B
2
A: Long Axis B: Short Axis
Volume(2Distance)
ml
Refer to Distance Meas. Formula:
V=(π/6)*D1*D2
2
D1: the longer distance D2: the shorter distance
Volume(3Distance)
ml
Refer to Distance Meas. Formula: V=(π/6)*D1*D2*D3
D1, D2, D3: Distance
3. Move the cursor to a point and press [ENTER] key to set the start point, then move the cursor
to next point and press [ENTER] key until the last point, and then set the straight line across the whole area.
4. The Volume of the chosen area will display on the measurement result area.
6.3 B Fast Measurement
Press [DIST] key to enter B Fast measurement in B mode. Press the corresponding parameter
control key to switch the fast measurement item.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Volume(1Dis1Ellip)
ml
Refer to distance and ellipse Meas. Formula: V=(π/6)*A*B*M
A: Long Axis B: Short Axis M: Distance
Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
General Measurement
Distance
cm
Refer to Distance Meas.
Perimeter/Area
Area:cm2 Perimeter: cm
Refer to Ellipse and trace meas.
Ellipse and trace. Press [UPDATE] key to change.
Volume(1Distance)
ml
Refer to Distance Meas. Formula:
V=(π/6)*D
3
D means: Depth
Volume(1Ellipse)
ml
Refer to ellipse meas. Formula:
V=(π/6)*A*B
2
A: Long Axis B: Short Axis
Volume(2Distance)
ml
Refer to Distance Meas. Formula:
V=(π/6)*D1*D2
2
D1: the longer distance D2: the shorter distance
Volume(3Distance)
ml
Refer to Distance Meas. Formula: V=(π/6)*D1*D2*D3
D1, D2, D3: Distance
Volume(1Dis1Ellip)
ml
Refer to distance and ellipse Meas. Formula: V=(π/6)*A*B*M
A: Long Axis B: Short Axis M: Distance
Ratio Ratio(distance)
Refer to Distance Meas. Formula: R=D1/D2
D1: First Distance D2: Second Distance
Ratio(area)
Refer to ellipse Meas. Formula: R=A1/A2
A1: First Area A2: Second Area
6.4 B General Measurement
Press [B], [2B] or [4B] to enter into B, 2B or 4B mode, then click [CALC] key to enter into
measurement status. Or press to choose the General measurement.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Angle
deg
Refer to Distance Meas.
Angle Range: 0°~ 180°
Histogram
Refer to histogram
Profile
Refer to Profile
Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Distance
cm
Refer to Distance Meas.
CBD
cm
Refer to Distance Meas.
GB wall
cm
Refer to Distance Meas.
Liver Length
cm
Refer to Distance Meas.
Prox Aorta
Height
cm
Refer to Distance Meas.
Width
cm
Refer to Distance Meas.
StD%
%
Refer to Distance Meas. Formula: ((D1-D2)/D1)*100 %
D1: Length of Normal D2: Length of Stenosis
StA%
%
Refer to ellipse Meas. Formula: ((A1-A2)/A1)*100 %
A1: Area of Normal A2: Area of Stenosis
Vessel Area
cm2
Refer to Ellipse and Trace Meas.
Ellipse and trace. Press [UPDATE] key to change.
Vessel Distance
cm
Refer to Distance Meas.
Mid Aorta
The same as above
The same as above
The same as above
The same as above
Distal Aorta
The same as above
The same as above
The same as above
The same as above
6.5 B Abdomen Measurement
Choose Abdomen exam mode. Freeze the required image, then Press [CALC] key to enter into
ABD measurement status. Or press to choose the Abdomen measurement.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Spleen
cm cm cm
Refer to Distance Meas. Formula: V=(π/6)*L*H*W
L: Length H: Height W: Width
Renal Volume (Right/Left)
cm
Refer to Distance Meas. Formula: V=(π/6)*L*H*W
L: Length H: Height W: Width
Lliac (Right/Left)
Height
cm
Refer to Distance Meas.
Width
cm
Refer to Distance Meas.
StD%
%
Refer to Distance Meas. Formula: ((D1-D2)/D1)*100 %
D1: Length of Normal D2: Length of Stenosis
StA%
%
Refer to ellipse Meas. Formula: ((A1-A2)/A1)*100 %
A1: Area of Normal A2: Area of Stenosis
Vessel Area
cm2
Refer to Ellipse and Trace Meas.
Ellipse and trace. Press [UPDATE] key to change.
Vessel Distance
cm
Refer to Distance Meas.
Meas. Menu
Submenu
Unit
Meas. Method
Comment
Distance
cm
Refer to Distance Meas.
GS cm
Refer to Distance Meas.
Formula to choose: CFEF, Campbell, Hadlock, Hansmann, Korean, Merz, Shinozuka
6.6 B OB Measurement
Choose OB exam mode. Freeze the required image, then Press [CALC] key to enter into OB
measurement status. Or press to choose the OB measurement.
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Meas. Menu
Submenu
Unit
Meas. Method
Comment
CRL
cm
Refer to Distance Meas.
Formula to choose: Hadlock, Hansmann, Korean, Nelson, Osaka, Rempen, Robinson, Shinozuka
BPD
cm
Refer to Distance Meas.
Formula to choose: Bessis, CFEF, Campbell, Chitty, Hadlock, Hansmann, Jeanty, Johnsen, Korean, Kurtz, Merz, Osaka, Rempen, Sabbagha, Shinozuka
HC cm
Refer to Ellipse and Trace Meas.
Formula to choose: CFEF, Campbell, Chitty, Hadlock, Hansmann, Johnsen, Korean, Merz
AC cm
Refer to Ellipse and Trace Meas.
Formula to choose: CFEF, Campbell, Hadlock, Hansmann, Korean, Merz, Shinozuka
FL cm
Refer to Distance Meas.
Formula to choose: Bessis, CFEF, Campbell, Chitty, Doubilet, Hadlock, Hansmann, Hohler, Jeanty, Johnsen, Korean, Merz, Osaka, Shinozuka
Fetal Biometry
YS
cm
Refer to Distance Meas.
OFD
cm
Refer to Distance Meas.
Formula to choose: Hansmann, Korean
APD
cm
Refer to Distance Meas.
Formula: Bessis
TAD
cm
Refer to Distance Meas.
Formula: CFEF
FTA
cm
Refer to Distance Meas.
Formula: Osaka
SL
cm
Refer to Distance Meas.
APTD
cm
Refer to Distance Meas.
Formula: Hansmann
TTD
cm
Refer to Distance Meas.
Formula: Hansmann
ThC
cm
Refer to Distance Meas.
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Meas. Menu
Submenu
Unit
Meas. Method
Comment
Fetal Long Bones
Humerus
cm
Refer to Distance Meas.
Formula to choose: Jeanty, Korean, Merz, Osaka
Ulna Long
cm
Refer to Distance Meas.
Formula: Jeanty
Tibia Long
cm
Refer to Distance Meas.
Formula to choose: Jeanty, Merz
Radius Long
cm
Refer to Distance Meas.
Fibula Long
cm
Refer to Distance Meas.
Clavicle Long
cm
Refer to Distance Meas.
Formula: Yarkoni
Fetal Cranium
Cerebellum
cm
Refer to Distance Meas.
Formula to choose: Chitty, Hill
CM
cm
Refer to Distance Meas.
NF
cm
Refer to Distance Meas.
NT
cm
Refer to Distance Meas.
OOD
cm
Refer to Distance Meas.
Formula: OOD
IOD
cm
Refer to Distance Meas.
NB
cm
Refer to Distance Meas.
LVent
cm
Refer to Distance Meas.
Formula: Tokyo
HC Width
cm
Refer to Distance Meas.
OB Others
LtKid
cm
Refer to Distance Meas.
RtKid
cm
Refer to Distance Meas.
LtRenalAP
cm
Refer to Distance Meas.
RtRenalAP
cm
Refer to Distance Meas.
LVWrHEM
cm
Refer to Distance Meas.
MAD
cm
Refer to Distance Meas.
AFI cm
Refer to Distance Meas.
AFI=AFI1+AFI2+AFI3+AFI 4
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Meas. Menu
Submenu
Unit
Meas. Method
Comment
CX_L
cm
Refer to Distance Meas.
6.6.1 Twins Measurement
1. In the new patient OB page, choose the number of gestation from one to four.
2. In the measurement menu, press baby A, and then press [ENTER] key to switch babies, which
could measure the babies separately.
6.6.2 EDD (estimated date of delivery) Estimation
6.6.2.1 Calculating EDD by LMP (Last menstrual period)
1. In the new patient OB page, update the LMP input box.
2. Choose the LMP from the date dialog box or input the LMP date directly.
3. The calculated EDD value will appear in the result measurement area of OB page.
6.6.2.2 Calculating EDD by BBT (Basal body temperature)
1. In the new patient OB page, update the Ovul.Date input box and input the bbt date.
2. The method is the same with the LMP method.
6.6.3 Growth curves
Function: Growth curves comparison is used to compare the measured data of the fetus with the normal growth curve in order to judge whether the fetus grows normally. Measurement steps:
1. Finish the measurement of the OB item and get into the report page.
2. Choose the growth curve at the right list and press [ENTER] key to display the growth curve.
3. Choose the growth curve need to display, and check it to show the growth curve on report.
4. Click [*] icon on the dialog box to exit.
LMP in patient information.
6.7 B Pediatrics Measurement
Select OB mode, press [CALC] to enter OB mode, then enter into pediatrics mode. Or press
Tips: The abscissa of Growth curves is the gestational weeks calculated according to the
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to switch to pediatrics measurement menu.
6.7.1 HIP Angle
HIP function is used for evaluating the fetal hip growth. In order to make calculation, three lines need to be added on the image, which is to conform to the fetal anatomic structure. The system will calculate and display two angles for doctor’s reference. Measurement steps:
1. Choose [HIP Angle] menu item, and click it to enter into measurement.
2. Click on the line image region, and appear one line with"+" .Move the line to the target
measurement region.
3. Rotate [MENU] knob to adjust the line angle, press [ENTER] key to fix the line.
4. Then appear the second line, adjust the line according to the step 3, and fix the line.
5. Fix the 3 lines; the measurement result of the angle appears in the district.
CAUTION:
D 3 shows bias line between protruding of conjunction and acetabular bone D 2 shows direct line between osileum and acetabular bone D 1 shows base line between cotyle, joint purse, gristle periosteum and ilium. β is the angle between D1 and D 2 (acute angle);α is the angle between D 1 and D 3(acute angle).
HIP angle
6.8 B ORTH Measurement
Refer to pediatrics measurement.
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Meas. Menu
Submenu
Unit
Meas. Method
Comment
Distance
cm
Refer to Distance Meas.
UT
UT_L
cm
Refer to Distance Meas.
CX_L
cm
Refer to Distance Meas.
UT_W
cm
Refer to Distance Meas.
UT_H
cm
Refer to Distance Meas.
Cervix Vol.
ml
Refer to Distance Meas. Formula: V=(π/6)*L*H*W
L: Cervix_Length H: Cervix_Height W: Cervix_Width
ENDO
cm
Refer to Distance Meas.
Ovary Volume (Left/Right)
ml
Refer to Distance Meas. Formula: V=(π/6)*L*H*W
L: Ovary_Length H: Ovary_Height W: Ovary_Width
Follicle (Left/Right)
Follicle width
cm
Refer to Distance Meas.
Follicle height
cm
Refer to Distance Meas.
Follicle Volume
ml
Formula of 2distance
V=(π/6)*A*B
2
Formula of 3distance V=(π/6)*L*H*W
2distance A: the longer distance B: the shorter distance 3distance L: follicle length H: follicle height W: follicle width
6.9 B GYN Measurement
GYN measurement includes measurement of UT-D (uterus diameter), ENDO (endometrium), CX-L (Uterine cervix length), LEFT OV and RIGHT OV (volume of left and right ovary) and LEFT FO and RIGHT FO (left and right follicle). The result will be calculated and displayed automatically on the screen by measuring relevant parameters. Freeze the required image under GYN examination, then press [CALC] key to enter into GYN measurement status.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Distance
cm
Refer to Distance Meas.
Thyroid (Left/Right)
ml
Refer to Distance Meas. Formula: V=(π/6)*L*H*W
L: Thyroid_ Length H: Thyroid_Heigh W: Thyroid_Width
Angle
deg
Refer to Distance Meas.
Angle Range: 0°~180°
Ratio
Refer to Distance Meas. Formula: R=D1/D2
D1: First Distance D2: Second Distance
Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Kidney Volume (Left/Right)
ml
Refer to Distance Meas. Formula: V=(π/6)*L*H*W
L: Kidney_L H: Kidney_H W: Kidney_w
Bladder Volume
V(L*W*H)
ml
Refer to Distance Meas. Formula: V=0.497*L*H*W
L: Bladder _L H: Bladder _H W: Bladder _w
Prostate Volume
ml
Refer to Distance Meas. Formula: V=(π/6)*L*H*W
L: Prostate _L H: Prostate _H W: Prostate _w
PPSA
ng/ml
Formula: PPSA=0.12*V
6.10 B Small Parts Measurement
Freeze the required image under Small parts examination, then press [CALC] key to enter into small parts measurement status.
6.11 B Vascular Measurement
Refer to normal measurement in B mode.
6.12 B Urology Measurement
Normally urology measurements are performed in B and 2B mode. Freeze the required image under Urology examination, then press [CALC] key to enter into Urology measurement status.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
PSAD
ng/ml
Formula: PSAD=SPSA/V
SPSA: input the SPSA when create a new patient
Residual
Volume
ml
Refer to Distance Meas. Formula: V=0.7*L*H*W
L: RVU_L H: RVU_H W: RVU_w
Meas. Menu
Submenu
Meas. Method/ Meas. Formula
Comment
Teichholz
LVIDd LVIDs
Refer to Distance Meas. Formula: EDV=(7*LVIDd3)/(2.4+LVIDd) ESV=(7*LVIDs3)/(2.4+LVIDs) SV=|EDV-ESV| CO=SV*HR/1000 EF=SV/EDV*100 FS=( LVIDd-LVIDs)/LVIDd*100 SI=SV/BSA CI=CO/BSA
Single Plane
EDV(A2C/A4C ) ESV(A2C/A4C)
Refer to Volume of A4CTrace method Formula: SV=|EDV-ESV| CO=SV*HR/1000 EF=SV/EDV*100 SI=SV/BSA CI=CO/BSA
Simpson BP
EDV(A2C) ESV(A2C) EDV(A4C) ESV(A4C)
Refer to Volume of A4CTrace method Formula: SV=|EDV-ESV| CO=SV*HR/1000 EF=SV/EDV*100 SI=SV/BSA CI=CO/BSA
6.13 B Cardiology Measurement
Normally urology measurements are performed in B and 2B mode. Freeze the required image under Cardiac examination, then press [CALC] key to enter into Cardiac status.
Hint: input the BSA when creating a new patient.
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Meas. Menu
Submenu
Meas. Method/ Meas. Formula
Comment
Modi Simpson
LVLd LVLs LVAMd LVAMs LVAPd LVAPs
Refer to Distance Meas. & Ellipse Mea. Formula: EDV=
ESV= SV=|EDV-ESV|
CO=SV*HR/1000 EF=SV/EDV*100 SI=SV/BSA CI=CO/BSA
Cube
LVSd LVIDd LVPWd IVSs LVIDs LVPWs
Refer to Distance Meas. Formula: EDV=LVIDd
3
ESV=LVIDs
3
SV=|EDV-ESV| CO=SV*HR/1000 EF=SV/EDV*100 FS=(LVIDd-LVIDs)/LVIDd*100 SI=SV/BSA CI=CO/BSA
Bullet Volume
LVLd LVLs LVAMd LVAMs
Refer to Distance Meas. Formula: EDV=(5/6.0)*LVLd*LVAMd ESV=(5/6.0)*LVLs*LVAMs SV=|EDV-ESV| CO=SV*HR/1000 EF=SV/EDV*100 SI=SV/BSA CI=CO/BSA
Gibson
LVIDd LVIDs
Refer to Distance Meas. Formula: EDV=π/6*(0.98*LVIDd+5.9)*LVIDd*LVIDd ESV=π/6*(0.98*LVIDs+5.9)*LVIDs*LVIDs SV=|EDV-ESV| CO=SV*HR/1000 EF=SV/EDV*100 FS=(LVIDd-LVIDs)/LVIDd*100 SI=SV/BSA CI=CO/BSA
Mitral Valve
MV Diam MV Area LA/AO
Refer to Distance Meas. & Ellipse Mea. Formula: LA/AO=LAD/AOD
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Meas. Menu
Submenu
Meas. Method/ Meas. Formula
Comment
Aortic Valve
AV Diam AV Area
Refer to Distance Meas. & Ellipse Mea.
Pulmonary Valve
PV Diam PV Area
Refer to Distance Meas. & Ellipse Mea.
Tricuspid Valve
TV Diam TV Area
Refer to Distance Meas. & Ellipse Mea.
LVOT
LVOT Diam LVOT Area
Refer to Distance Meas. & Ellipse Mea.
RVOT
RVOT Diam RVOT Area
Refer to Distance Meas. & Ellipse Mea.
RV/LV
RVIDd LVIDd
Refer to Distance Meas. Formula: RV/LV=RVIDd/LVIDd*100
PISA
PISA MR(Rad, Als Vel) PISA AR(Rad, Als Vel) PISA TR(Rad, Als Vel) PISA PR(Rad, Als Vel)
Refer to Distance Meas. Formula: Flow Rate=2π*Rad*Rad*Als Vel
LV Mass
Cube(LVSd, LVIDd, LVPWd)
Refer to Distance Meas. Formula: LV Mass=1.04*(( LVSd+ LVIDd+ LVPWd)3­LVIDd3)-13.6 LV Mass Index=LV Mass/BSA
A-L(LVAd sax Epi, LVAd sax Endo, LVLd apical)
Refer to Distance Meas. & Ellipse Mea. Formula:
T-E(LVAd sax Epi, LVAd sax Endo, a, d)
Refer to Distance Meas. & Ellipse Mea. Formula:
Qp/Qs
AV Diam PV Diam
Refer to Distance Meas.
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6.13 Normal Measurement in M, B/M mode
At real-time status, press [M] key twice to enter M mode, press [CALC] key to enter into M mode measurement status. OR At real-time status, click [M] key to enter B/M mode, press [CALC] key to enter into M mode measurement status.
6.13.1 Distance
Measurement steps:
1. Select menu item [Distance]to enter into measurement.
2. Click on the M image area, it will display an orange dotted line with two horizontal short line.
The orange dotted line represents the position need to be measured. The distance between the
two short lines is the distance you want to measure. The yellow short line represents it’s in active
status. Click it and drag the short line to anywhere you want to put.
3. Press [UPDATE] key to activate the two short lines in turns and drag them to change the
distance between them. The measurement result will be displayed on the result area.
6.13.2 Time
Measurement steps:
1. Select menu item [Time] to enter into measurement.
2. Click on the M image area, it will display two orange straight dotted line. The orange dotted line
with one yellow short line on it represents it is in active status. The distance between the two straight lines stands for time you want to measure. You can drag the active straight line to anywhere you want to change the measured time.
3. Press [UPDATE] key to activate the two straight lines in turns and drag them to change the
distance between them. The measurement result will be displayed on the result area.
6.13.3 Heart rate
Heart rate is used to calculate the number of heart beats per minute from cardiac image. Measurement steps:
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Distance
cm
Refer to M Distance Meas.
Time
s Refer to M Time Meas.
Velocity
cm/s
Refer to M Velocity Meas.
Heart Rate One Cycle
bpm
Refer to M Time Meas.
Double Cycles
bpm
Refer to M Time Meas.
1. Choose [Heart Rate] menu item to enter into measurement.
2. The method is the same as Time.
3. After the above measurement, the calculated heart rate result is displayed in the measurement result area.
4. Repeat the steps form1 to 3 to start next measurement.
6.13.4 Velocity
Measurement steps:
1. Click [Velocity] menu item to enter measurement condition.
2. Select the starting point and press [ENTER] key, the starting point and the removable cursor
display, drag cursor to the end point.
3. Press [ENTER] key again, measurement completes, the result displays in the region of
measurement
4. Repeat 1~3, and enter the next measurement of velocity.
NOTE: The maximum number of the measurement result on the image area is one. The
second measurement result will cover the first one. The measurement result area will list all the measurement values.
6.14 General Measurement in M mode
At real time status, press [M] key twice to enter M mode, click [CALC] key to enter into M mode cardiology measurement status.
6.15 M Cardiology Measurement
Freeze the required image under Urology examination, then press [CALC] key to enter into
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Meas. Menu
Submenu
Meas. Method/ Meas. Formula
Comment
Distance
Refer to M Distance Meas.
Time
Refer to M Time Meas.
Slope
Refer to M Velocity Meas.
Left Ventricle
Cube(LVSd, LVIDd, LVPWd, LVSs, LVIDs, LVPWs)
Refer to M Distance Meas. Formula: EDV=LVIDd3 ESV=LVIDS
3
SV=|EDV-ESV| CO=SV*HR/1000 EF=SV/EDV*100 FS=( LVIDd-LVIDs)/LVIDd*100 SI=SV/BSA CI=CO/BSA
Teichholz(LVIDd, LVIDs)
Refer to M Distance Meas. Formula: EDV=7*LVIDd3/(2.4+ LVIDd) ESV=7*LVIDs3/(2.4+ LVIDs) SV=|EDV-ESV| CO=SV*HR/1000 EF=SV/EDV*100 FS=( LVIDd-LVIDs)/LVIDd*100 SI=SV/BSA CI=CO/BSA
Gibson(LVIDd, LVIDs)
Refer to M Distance Meas. Formula: EDV=π/6*(.98*LVIDd+0.59)*LVIDd
2
ESV=π/6*(1.14*LVIDs+4.18)*LVIDs2 SV=EDV-ESV CO=SV*HR/1000 EF=SV/EDV*100 FS=( LVIDd-LVIDs)/LVIDd*100 SI=SV/BSA CI=CO/BSA
IVSd/LVPWd
Refer to M Distance Meas.
Mitral Valve
EPSS
Refer to M Distance Meas.
MV E Amp
Refer to M Distance Meas.
MV A Amp
Refer to M Distance Meas.
MV D-E Exc Dist
Refer to M Velocity Meas.
MV E-F Slope
Refer to M Velocity Meas.
MV D-E Slope
Refer to M Velocity Meas.
A-C Int Slope
Refer to M Velocity Meas.
Urology measurement status. Or press to choose the cardiac measurement.
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Meas. Menu
Submenu
Meas. Method/ Meas. Formula
Comment
E Duration
Refer to M Time Meas.
A Duration
Refer to M Time Meas.
Aortic Valve
AOD
Refer to M Distance Meas.
Ao Sinus Diam
Refer to M Distance Meas.
Ao Asc Diam
Refer to M Distance Meas.
Ao Arch Diam
Refer to M Distance Meas.
Ao Desc Diam
Refer to M Distance Meas.
LVOT Diam
Refer to M Distance Meas.
LAD
Refer to M Distance Meas.
LVPEP/LVET
Refer to M Time Meas.
AA
Refer to M Distance Meas.
Tricuspid Valve
RVOT Diam
Refer to M Distance Meas.
RA Diam
Refer to M Distance Meas.
D-E Exc Dist
Refer to M Velocity Meas.
E-F Slope
Refer to M Velocity Meas.
A-C Int Time
Refer to M Velocity Meas.
Pulmonar y Valve RVPEP
Refer to M Time Meas.
RVET
Refer to M Time Meas.
A wave Amp
Refer to M Distance Meas.
B-C Slope
Refer to M Velocity Meas.
RV/LV
RVIDd LVIDd
Refer to M Distance Meas.
6.16 Other Urology Measurement in M Mode
M Abdomen, OB, GYN, Urology, Small Parts, Pediatric and ORTH measurement refer to general measurement in M mode.
6.17 PW mode measurement methods
Press [D] key to enter PW mode, and then press [CALC] key to enter PW mode measurement.
NOTE:
In order to get accurate result, the PW image must be clear and high quality. Insure that you have fixed the cursor at the exact place of cardiac systole and diastole.
6.17.1 Velocity
Measurement steps:
1. Select menu item [Velocity] to enter into measurement.
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2. Click on the PW image area, the measurement result will be displayed on the result area.
6.17.2 Time
Measurement steps:
1. Select menu item [Time] to enter into measurement.
2. Click on the PW image area, it will display two orange straight dotted line. The orange dotted
line with one yellow short line on it represents it is in active status. The distance between the two straight lines stands for time you want to measure. You can drag the active straight line to anywhere you want to change the measured time.
3. Press [UPDATE] key to activate the two straight lines in turns and drag them to change the
distance between them. The measurement result will be displayed on the result area.
6.17.3 Slope
Measurement steps:
1. Click [Slope] menu item to enter measurement condition.
2. Select the starting point and press [ENTER] key, the starting point and the removable cursor
display, drag cursor to the end point.
3. Press [ENTER] key again, measurement completes, the result displays in the region of
measurement
4. Repeat 1~3, and enter the next measurement of slope.
6.17.4 Auto Trace
Measurement steps:
1. Move the trackball to select the start point of the one cycle and press [ENTER] key to fix it.
2. A second cursor “^” will appear, and move the trackball to the end point of the cycle, press
[ENTER] key to fix it.
3. The measurement results will be displayed on the monitor and calculate other values of
parameters.
6.17.5 Manual Trace
Measurement steps:
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