Q9 User Manual

Q9 Digital Color Doppler Ultrasound System
Digital Color Doppler Ultrasound System

Model
Q9
OPERATION MANUAL
Direction: CHUMQ9-001
V1.0
December 10, 2013
CHISON MEDICAL IMAGING CO., LTD.
We reserve the right to make changes to this manual without prior notice.
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 Q9. Please verify that you are using the latest revision of this
document. If you need the latest revision, contact your distributor.
Important
1. No part of this manual may be reduced, 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.
Important information
1. It is the customers 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 the software or hardware of this system and
probes.
4. During operate the system, if user has any doubt, difficulty or any unclear, please
contact CHISON's authorized service engineer immediately. Please describe the
situation clearly to solve the question in time. Before solve the question, please dont
operate the system.
5. This system shall not be used by persons other than fully qualified and certified
medical personnel.
6. The System modified or repaired by people other than CHISONs qualified service
engineers, CHISON shall not be liable for the system.
7. The purpose of this system is to provide physicians with data for clinical diagnosis. It
is the physicians responsibility for diagnostic procedures. CHISON shall not be
liable for the results of diagnostic procedures
8. 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.
9. Due to negligence not following operation manual, CHISON shall not be liable for
the results.
10. Each time before and after ultrasound examination, please check the probe surface,
probe cable and sheath whether they are abnormal, such as cracking, peeling and
deformation. Also check whether the lens is strongly fixed. Abnormal probes may
cause electric shock and injure the patient. Once any abnormal, user must stop using
and contact CHISON's authorized service engineer.
11. If the probe is dropped or scratched by hard part, please stop using the probe
immediately. And contact CHISON's authorized service engineer to make sure the
safety and effectiveness is in good condition before use.
12. 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 CHISONs authorized service engineer
to make sure its safe before restart using it.
13. Please don't use solvents (such as paint thinner, benzine, or alcohol) or abrasive
cleansers for cleaning the system (including monitor and probes, etc). It may corrode
the system and probes.
14. While the system or probe is over life time, please refer to operation manual section
9.5.
15. 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.
16. Please put this operation manual with the system to ensure operator and manager can
reach it at any time.
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION..................................................................................................................................................... 1
1.1 System Overview............................................................................................................................................................. 1
1.2 Contact Information......................................................................................................................................................... 1
CHAPTER 2 SYSTEM SAFETY......................................................................................................................................................... 2
2.1 Safety Overview...............................................................................................................................................................2
2.2 Electrical Safety............................................................................................................................................................... 3
2.3 Labels........................................................................................................................................................................... 5
2.4 Patient Environmental Devices.................................................................................................................................... 6
2.5 Biological Safety.......................................................................................................................................................... 8
2.6 Scanning Patients and Education..................................................................................................................................9
CHAPTER 3 PREPARING THE SYSTEM FOR USE........................................................................................................................ 16
3.1. Site Requirements.......................................................................................................................................................16
3.2. System Specifications.................................................................................................................................................17
3.3. System Positioning & Transporting........................................................................................................................... 21
3.4. Powering the System.................................................................................................................................................. 22
3.5. Probes......................................................................................................................................................................... 24
3.6 Optional installation................................................................................................................................................... 26
3.7 User Interface Control................................................................................................................................................ 30
CHAPTER 4 IMAGING........................................................................................................................................................... 37
4.1. General Description....................................................................................................................................................37
4.2. Beginning an Exam.................................................................................................................................................... 37
4.3. Optimizing the Image................................................................................................................................................. 41
4.4. After Capturing the Image..........................................................................................................................................60
CHAPTER 5 GENERAL MEASUREMENTS.......................................................................................................................................74
5.1 Key for Measurement................................................................................................................................................. 74
5.2 Fast measurement....................................................................................................................................................... 75
5.3 Measurement and Calculation.................................................................................................................................... 79
5.4 Edit measurement results.......................................................................................................................................... 117
5.5 Report....................................................................................................................................................................... 117
CHAPTER 6 PRESET.................................................................................................................................................................... 120
6.1. Recall Preset...................................................................................................................................................................120
6.2. Save user defined preset.................................................................................................................................................120
6.3. Manage Preset................................................................................................................................................................ 121
CHAPTER 7 SYSTEM SETTING................................................................................................................................................. 122
7.1. General settings.............................................................................................................................................................. 122
7.2 Measurement................................................................................................................................................................... 124
7.3 Comment:........................................................................................................................................................................ 126
7.4 Report.............................................................................................................................................................................. 127
7.5 Network...........................................................................................................................................................................130
7.6 System............................................................................................................................................................................. 134
CHAPTER 8 PROBES................................................................................................................................................................... 144
8.1. General Description....................................................................................................................................................... 144
8.2. Care and Maintenance....................................................................................................................................................144
8.3 Probe Operation Instructions...........................................................................................................................................153
CHAPTER 9 SYSTEM MAINTENANCE AND TROUBLESHOOTING................................................................................................. 156
9.1 Back up information.....................................................................................................................................................156
9.2 System Care and Maintenance..................................................................................................................................... 156
9.3 Safety Check................................................................................................................................................................ 158
9.4 Troubleshooting........................................................................................................................................................... 158
9.5 Service Responsibility..................................................................................................................................................159
APPENDIX A THE INFORMATION OF CE REPRESENTATIVE..................................................................................................162
APPENDIX B SYSTEM ONE-KEY-RECOVERY FUNCTION....................................................................................................... 163
APPENDIX C MAXIMUMACOUSTIC OUTPUT REPORT.............................................................................................167
APPENDIX D TRANSDUCER MAXIMUM SURFACE TEMPERATURE....................................................................................... 189
APPENDIX E GUIDANCE AND MANUFACTURERS DECLARATION....................................................................... 190
APPENDIX F MEASUREMENT RESULTS SUMMARY.................................................................................................. 194
1
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 keep 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/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult &
pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transvaginal.
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:
CHISON website www.chison.com
Service Support CHISON Medical Imaging Co., Ltd.
Tel: 0086-400-8878-020; 0086-0510-85311707
Fax: 0086-0510-85310726
E-mail: service@chison.com.cn
Placing an Order CHISON Medical Imaging Co., Ltd.
Tel: 0086-0510-8531-0593/0937
Fax: 0086-0510-85310726
Email: export@chison.com.cn
Manufacturer CHISON Medical Imaging Co., Ltd..
No. 8, Xiang Nan Road, Shuo Fang,
New District, Wuxi, China 214142
US Agent: MR. NANPING WU, 3040 Edenberry Street, Madison, WI 53711 USA
Phone: 608-277-9432, Fax: 920-648-1584
Email: nanpingwu@yahoo.com
Caution: Federal law restricts the device to sale by or on the order of a licensed practitioner or therapist.
2
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 Chapter 2
System Safety in the 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 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.
3
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.
NOTE:
*To dispose of this product properly, please contact the local CHISONs 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 particular regard to
allowable LEAKAGE CURRENT
BF: Isolation from ground; max. Patient leakage current: normal mode 100 A, single fault condition 500 A
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 three-hole outlet.
Do not remove or circumvent the grounding wire.
4
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.
Suggest power off the system in 30 minutes if the system continuously works in 8 hours.
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 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 by 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)
5
2.3 Labels
Fig.2-1 Rear panel label
2.3.1 Symbols on label
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.
Dangerous electric voltage. Unplug the main plug
before opening the system!
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
these devices power off when near this equipment.
Be careful of static.
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 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 with the Council Directive
93/42/EEC
AUTHORIZED REPRESENTATIVE
IN THE EUROPEAN COMMUNITY: This symbol is
Insulated patient application part (Type BF)
6
accompanied by the name and the address of the
authorized representative in the European Community.
This symbol is followed by the serial number
of the device.
MANUFACTURER: This symbol is
accompanied by the name and the address of the
manufacturer.
Potential equilibrium connection
Main power switch ON
Main power switch OFF
Power On/off.
CAUTION: This Power Switch DOES NOT ISOLATE
Mains Supply.
The Alternating current symbol indicates that
the equipment is suitable for alternating current only.
This symbol signifies that the user manual must be read.
IPX7
Protection against the effects of immersion (probes)
IPX0
No protection against ingress of water (system)
Rx only
This symbol indicates that in the united states of
America, Federal law restricts the device to sale by or on
the order of a licensed practitioner or therapist.
This symbol is followed by the manufacturing date of the
device in the form YYYY-MM.
2.4 Patient Environmental Devices
Left side (refer to Fig. 3-1 b in Chapter 3):
TV Video port: B/W or Color Printers
1 LAN port: LaserJet Printer
1 VGA port: External monitor
2 USB ports
1 S-Video port
Rear panelrefer to Fig.3-1c in Chapter3:
1 Footswitch port
1 Remote port
2 Probe ports
CAUTION:
7
VIDEO, SVIDEO and VGA are not designed to work at the same time, only one port can work
at one time. Please select your most suitable 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.
The system cant 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: Mitsubishi P93W; Sony UP-897MD Sony UPD-711MD
Color video printer: Mitsubishi CP31W
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-
1.
The connection of equipment or transmission networks other than as specified in the user instructions can result in an
8
electric shock hazard or equipment malfunction. Substitute or alternate equipment and connections require
verification of compatibility and conformity to IEC/EN 60601-1-1 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 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 users 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. Dont connect the ultrasound system to Internet.
Make sure your hospitals 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
9
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.
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 patients body.
Move probe away from the patient when not actively scanning.
10
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 bioeffect 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.
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
11
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:
TI
Maximum exposure
time (minutes)
0.7 60
1.0 30
1.5 15
2.0 4
2.5 1
Table 2-2 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/cm
2
and either the global maximum MI must be 1.9 or the global maximum de-rated Isppa must be 190 W/cm
2
. An
exception is for ophthalmic use, in which case the TI = max (TIS_as, TIC) is not to exceed 1.0; Ispta.3 50mW/cm
2
,
12
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/cm
2
under an Output Display
Standard.
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 2.5C must be
present consistently at one spot for 2 hours to cause fetal abnormalities. Avoiding a local temperature rise
above 1C 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).
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
13
8 0.5754 0.1903 0.0631 0.0158
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.
Thermal Models Composition Mode Specification Application
1 TIS Soft tissue Unscanned
Large aperture (>1cm
2
)
Liver PW
2 TIS Soft tissue Unscanned
Small aperture (<1cm
2
)
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/scanned Bone at surface Transcranial
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.
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 1C (W
deg
), TI = W.3/W
deg
.
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 1C temperature elevation in soft tissue is:
W
deg
= 210/fc, for model 1 to 4, where fc is the center frequency in MHz.
W
deg
= 40 K D for 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.
14
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 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, 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
15
controls.
Direct: The Acoustic Output control has the most significant effect on Acoustic Output.
Indirect: Indirect effects may occur when adjusting controls. Controls that can influence MI and TI are detailed
under the bioeffect 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 TGC.
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 effect 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.
16
Chapter 3 Preparing the System for Use
3.1. Site Requirements
3.1.1. Operation Environmental Requirements
The following environmental conditions are within system tolerances for operation:
Temperature: 10 C ~ 40 C
Relative Humidity: 30%~75%, non-condensing
Atmosphere Pressure: 700hPa ~ 1060hPa
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.
17
3.1.2. Transport and Storage Environmental Requirements
The following environmental transport and storage conditions are within system tolerances:
Temperature: -5 C ~ 40 C
Relative Humidity: 80% non-condensing
Atmosphere Pressure: 700hPa ~ 1060hPa
3.1.3. 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 cant buy and exchange the fuse
by themselves.
Power Consumption: 300 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 cord, 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 cords that meet the system
guidelinesfailure to follow these procedures may result in 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.
3.2. System Specifications
3.2.1. Console Overview
18
Fig. 3-1 a: Console Overview
The following pictures show the system in different views.
Fig. 3-1 b: System Side View
Handle
LCD monitor
Control panel
USB port
VGAport
TV port
LAN port
S-Video
19
Fig. 3-1 c: System Back view
3.2.2. Physical Specification
Dimensions of main unit (approx.): 370mmLength*185mmWidth*395mmHeight
Net weight of main unit (approx): <11KG (no probe included)
3.2.3. Key System Features
Display B2DB/B4BB/MMPWDCFMCPADPDCWSteer MColor M TDI
B/BCHPRFTriplexPanoramic imagingTHITrapezoid Imaging4D
ECG
Zoom and depth adjustment.
Set the total gain, contrast, frequency band, 8 segments of TGC , dynamic range, persistence.
Image post-processing of raw data: measurement and zoom after freezing the image
256 gray-scale image display technology, i-Image
TM
technology, stable performance, high resolution;
Image freezing and storage function; the stored images can be recalled for analysis
Storage file format: single and movie file formats
Scanning direction can be changed and the image can be reversed in left/right, up/down direction.
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;
20
Elliptical method and tracing method are provided for area/circumference measurement
Many kinds of body marks can be displayed together with corresponding probe position indication.
Comment function in image area of the screen, special comment terms for different exam mode can be added
according to users requirement;
Display of Patient ID, Time and Date display according to real-time clock.
Trackball available for operation and measurement. Characters can be input directly by keyboard.
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.
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.
Image Modes
B mode
Color Doppler mode
Power Doppler mode (also named Color Power Angio)
Directional Power Doppler mode
PW Doppler mode
B/M mode
M mode
Dual display
Quad display
Trapezoidal mode (only for linear probe)
CW
Steer M
Color M
TDI
B/BC
HPRF
Triplex
Panoramic imaging
THI
4D
3.2.4. Accessories
D3C60L
D7L40L
D6C12L
D12L40L
D3P64L
21
V4C40L
Foot switch
3.2.5. I/O ports
VGA output for external monitor
S-VIDEO,TV output for B&W video printer or Color video printer
Remote port for video printer
LAN port output for PC printer, DICOM and image review station
2 USB 2.0 ports for flash drive
Foot switch port
3.3. System Positioning & Transporting
Moving the System
When moving or transporting the system, take the precautions described below to ensure maximum
safety for personnel, the system and other equipments.
Before Moving the System
Completely switch off the system. See Section 3.4.4 Power Off for more information.
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.
Disconnect all probes from main unit. See Section 3.5 Probes for more information.
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. 12 kg. In order to
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
22
Use extra care when transporting the system in a vehicle. After preparing the system as described above, take the
following additional precautions:
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. 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.
3.4. Powering the System
3.4.1. Acclimation Time
After being transported, the unit requires one hour for each 2.5 increment if its temperature is below 10 C or
above 40 C.
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.
3.4.2. Connecting and Using the System
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.
23
WARNING:
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.
3.4.3. Power On
NOTE:
Turn on the green power switch (main power circuit breaker switch, see Fig. 3-1 c in Section
3.2.1 Console Overview) at the back of the system, and then press the Power button on the left
of control panel to turn on the system.
Power up Sequence:
The system is initialized and start-up status is reflected on the monitor:
control panel flashing and then getting dark
system checking BIOS data
booting the operation system
loading software
entering examination status
HINTS
The power up procedure takes about approx. 180 seconds. If a problem occurs, take a picture
and record the error information for service reference.
NOTE:
While the system is on, DO NOT fold the keyboard.
While unfolding the keyboard, please hold and place the keyboard slowly and lightly on
the desk.
After power off the system, please wait for more than 3 minutes to power on again.
When the system is powered on, for safety reason, please avoid the following
- close the keyboard
- move the system
3.4.4. Power Off
To power off the system:
Press the Power button on the left of control panel.
When the screen shows Turn Off, Restart, and Cancel, press Turn off to shutdown the system.
24
NOTE:
If the system is down or has not fully shut down, press and hold the Power button located on
the left of control panel for more than 4 seconds and release it, this will force the system to shut
down completely.
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. 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. Place the system in
Transducer Selection interface by pressing PROBE-key to deactivate the probe ports.
To connect a probe:
Place the probes 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.
25
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.3-2 a Probe connector Unlock status Fig.3-2 b 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 Transducer Selection interface. If necessary, press the PROBE-key to return. .
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 Transducer Selection interface.
To disconnect a probe:
Turn the connector locking lever to an 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.
Transporting the Probe
26
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.
3.6 Optional installation
3.6.1 Connect the printer.
1) It needs three cables: Remote cable, Video signal cable, Power cord. See picture in Fig.3-3a.
Note:
If you don't connect remote cable, you still can do the printing by pressing the key on printer.
Fig.3-3a
2) Connect the remote cable to remote port on the rear panel of ultrasound system. See picture in Fig.3-3b.
Remote
cable
Video signal
cable
Power cord
27
Fig. 3-3b
3) Connect the video signal cable to the TV port of the ultrasound system as below. See picture in Fig. 3-3c.
Fig. 3-3c
3.6.2 Set the system for Video Printer.
Caution:
Please confirm the video printer is turned on and connected well with the main unit, then you can do below setting.
1) Press the setup key; enter "system" interface, then select "Display Setting ". See picture in Fig.3-4.
28
Fig.3-4
2) Choose "Extended Desktop" for Operation Mode.
3) Choose Notebook for Primary Device, and choose Secondary Device for Television, and then press
apply. See picture in Fig.3-5
Fig.3-5
4) The below dialog box will appear, and press OK. See picture in Fig.3-6.
Note:
The screen will be black for a while.
29
Fig.3-6
5) Set the video print option to choose different methods for video print.
Choose the General setting, and select Keyboard submenu. See picture in Fig. 3-7.
Fig.3-7
6 Choose video print under print key menu or Foot SW menu, and set the video print option.
Fig.3-8
30
Image only means only print the ultrasound image.
Standard means print the ultrasound image with patient information.
7) Press the print key on keyboard or use foot switch for printing.
Note:
You need to restart the system after connect the cables between Video printer and the System.
You can't print the system information.
3.6.3 Connect the PC printer
1. Place the printer smoothly.
2. Connect the printer to the system.
3. Set the print manager. Please see more information in 7.6.
4. Choose PC print in system setting, and in the PC print selection, chooses print the image with
information, or only print image.
3.7 User Interface Control
B gain, Color gain and Doppler gain
TGC
Brightness
Acoustic power
Gamma
Smooth
Edge enhance
Persistence
Depth control
Focal position/number
Dynamic range selection
Audio volume control
i-Image
TM
Space compound imaging
Freeze/Unfreeze
Image storage
Scanning width
Zoom
Dual display: Dual B or color
Quad display
L/R inversion
U/D inversion
Biopsy guide
PRF
Wall filter
31
Blood Effection
Steering
Color ROI panning
Doppler sample volume adjustment
Doppler angle correction
Baseline movement
Time base scrolling speed
Annotation
Patient data entry
Measurement and calculation package
File management and image archiving
Clip image saving
DICOM setting
User defined preset
3.7.1 Control Panel and Alphanumeric Keyboard
Fig. 3-3: Overview of Control Panel and Alphanumeric Keyboard
See layout of the Control Panel and Alphanumeric Keyboard in the above figure.
The main function of each key is introduced as below.
3.7.2 Exam Function Controls
32
This group of controls performs patient entry, exam mode/probe type selection and report production etc.
POWER
Press system power key momentary on the left of Alphanumeric
Keyboard to turn on the system. Press this key and choose turn
off to turn off the system. Press this key longer than 4 seconds to
force the system to shut down in case the system is down.
PATIENT
Use the PATIENT-key to start a new patient record, edit a current
patients data, or select a patients exam data from worklist.
PROBE
Press PROBE-key to enter the Transducer Selection interface
showing all available applications supported for the probes
connected to the system
END
Finish the exam of current patient; delete the information of
current patient.
SETTING Do user defined setting of the system
3.7.3 Mode, Display and Record
This group of controls provides various functions related to the display mode, display orientation, image
recording/saving, freezing etc.
B mode
Press the B-knob to turn on B-mode imaging. The system will stay
in B mode if the current state is B, or return to B-mode if the
current state is not B (e.g. M, color, Duplex Doppler).
Rotate this knob to change the overall B gain throughout the image.
CFM mode
Press the C-knob to turn on the Color Flow Map (CFM) mode if
the systems current state is B;
Press this knob can turn on Color if the systems current state is
duplex Doppler;
Press the C-knob for second time to turn off color and return to the
previous mode (either B-mode or Duplex Doppler).
Rotate C-knob to change the overall Color gain for CFM (PD)
mode.
PD (CPA) mode
Activate/turn off PD Mode (also named as Color Power Angio mode).
Press the CPA-key to turn on the PD mode if the system is in B
mode;
Press the CPA-key for second time to turn off PD and return to the
previous mode (either B-mode or duplex Doppler)
PW mode
Press the PW-knob to turn on the duplex Doppler duplex mode if
the current mode is B;
Rotate the knob to change the overall Doppler gain for PW mode,
when activate the spectral Doppler mode.
33
CW mode
If the probe supports CW mode, e.g. a phased array probe, press
CW-key starts CW mode. The CW control operates in the same
manner as the PW.
M mode
Press the M-knob to enter B/M mode if the current mode is B;
Press the M-knob for second time to enter M-mode without B-
mode
Press the M-knob for third time to go back to B-mode
Rotate the knob to change the overall M gain throughout the image
TDI
Press the TDI key to turn on the TDI mode if the current mode is
B;
Dual mode
This key splits the imaging screen for a side-by-side image
comparison.
Press Single-mode to quit.
Quad mode
Four single B mode images can be displayed at the same time
when pressing Quad- mode. One is active and the other three are
frozen. Press the key again to switch the active one
Press Single-mode to quit.
Single mode Enter into the single image display mode.
UPDATE
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.
In Measurement mode, it can be used to switch between start point
and end point (distance), long-axis and short-axis (ellipse), and
return back to last position in trace measurement before the
measurement is finished.
THI
Turn on/off THI (Tissue Harmonic Imaging). THI can be activated
in 2D mode.
FREEZE
Freeze/Un-Freeze the ultrasound image and enter/quit the Cine
mode automatically.
ZOOM
Press the ZOOM-knob to turn on the zoom function.
SAVE Store still images.
SAVE CLIP Store selected clips.
34
Browse
Press the key to browse images, edit or print the stored images,
etc.
REPORT Press this key to generate a report with all the measurements
PRINT Print the images when the printer is working.
3.7.4 Measurement & Annotation
This group of controls performs various functions related to making measurements, annotating etc.
Trackball
Position calipers in measurement;
Position mouse cursor for exam mode selection;
Position the M-mode, PW cursor;
Select entry in soft-menu; Select EXAM mode;
Position and re-size the Color Region of Interest (CROI);
Position and re-size the Doppler Sample Volume Gate;
Control digital cine review frames.
Enter
Confirm the command entry;
Confirm EXAM mode and menu setting;
Confirm caliper and measurement setting;
Toggle Trackball function between Re-sizing and Re-positioning
for the CROI, and Doppler Sample Volume Gate.
DEL
Press DEL-key to clear all measurement path, measurement result,
comments, body marks from the imaging screen
EXIT Exit from current operation status
Body Mark
Press the Body Mark-key in real time or cine mode to bring up the
entire sets of available Body Mark icons associated with the
current application.
COMMENT
Comments can be added in the image area in real time or cine mode.
Manual entry or recalling the phrases from annotation library is
allowed.
Press COMMENT-key to enter Comment mode.
Press this key during annotation entry to confirm the annotation
and quit from Comment mode.
ARROW
Press the ARROW-key and the mouse cursor will appear on the
screen.
35
DIST
In 2D (B and Color) cine mode, DIST-key is used for Distance
measurement.
In Doppler cine mode, press DIST-key one time to measure Flow
Velocity.
In M cine mode, press DIST-key for Distance measurement
TRACE
In 2D mode, TRACE-key is for measurement of
Area/Circumference with tracing method.
In Doppler cine mode, this key can be used to calculate PI and
RI ,and can envelope automatically
CALC
Use this key to activate calculation packages under different
applications. This feature supports the optional OB, GYN, Vessel,
Urology, Cardiac, Small parts, Pediatrics, Carotid Abdomen and
General calculation packages. Refer to Measurement & Calculation
section for details.
3.7.5 Image Controls
MENU
This key provides multiple functions according to the active mode on
the screen.
In real-time mode, it accesses the Soft- Menu that corresponds to
each mode. Press MENU-knob for second time to select the item
and adjust the parameters. Press MENU-knob for third time to
exit from current item. Rotate the MENU- knob to select the
item
TGC Sliders
Manipulate the TGC (Time Gain Compensation) with 8 pairs of
sliders.
DEPTH Press this paddle up/down to change the image depth of view.
PRF
Press this paddle up/down to change PRF setting in the color or
Spectral Doppler modes.
BASELINE
Use this paddle to control the zero velocity Baseline shifting. In
Color mode, the maximum detectable velocity is stretched. In
Spectral Doppler mode, the spectrum is wrapped around.
FOCUS
Use this paddle to move the transmitted focal position up or down
in any mode while B mode is active. The transmitted focal
position remains at the center of the Doppler Sample Volume Gate
in spectral Doppler mode, and at the center of the CROI in color
mode.
36
STEER
In Color mode, use this paddle to change the CROI steer angle for
linear probe; in Doppler mode, this paddle can be used to change
PW cursor steering directions for linear probe.
WALL FILTER
Use this paddle to change the setting of the Wall Filter in the color
or Doppler modes.
ANGLE
In the Spectral Doppler mode, the default angle correction feature
remains active. In the real time or cine modes, rotate this knob to
adjust the Doppler Angle Correction by lining up the cursor with
the vessel wall for an accurate reading. The Doppler Angle
Correction setting can be adjusted 5 degrees at a time.
Rotate it to adjust the probe direction on the body mark status.
SK1-SK5
Press the key to change the parameter on upper line while rotate
the key to change the parameter on below line of the
corresponding menu at the bottom of the screen.
INVERT
In Color mode, the flow direction (blue and red) can be inverted
by pressing the INVERT key.
In PW mode, the spectrum will be reversed according to the
baseline when INVERT key is pressed.
AIO
AIO means Automatic Imaging Optimization. During image
scanning, press this key will optimize the image for a better
quality in resolution automatically.
U/D (Up/Down
Reversion)
Reverse the 2D(B or Color) image orientation 180 degrees
L/R (Left/Right
Reversion)
In single image mode, use L/R-key to reverse the image between the
left/right orientations;
Change Change menu in different mode
3.7.6 Soft-Menu Controls
The Soft-Menu is activated depending on the current active mode. The Soft-Menu will provide a second level control
to set the parameters in the system. The default setting depends on different applications.
Soft-Menu provides the user with an easy and flexible approach to access additional system controls. The system will
display the appropriate menus for the selected Mode and functions.
37
Chapter 4 Imaging
4.1. General Description
How to begin an exam
How to select a probe and an application.
How to optimize the image
The operations after getting the image: adding annotation and body mark, storing and recalling the image
4.2. Beginning an Exam
Begin an exam by entering new patient information. You should enter as much information as possible, such as
patient ID, patient name.
The patients name and ID number are retained with each patients image and transferred with each image during
archiving or hard copy printing.
CAUTION:
To avoid patient identification errors, always verify the identification with the patient. Make sure
the correct patient identification appears on all screens and hard copy prints.
4.2.1. Selecting a Probe and an Application
The system has two built-in probe connectors, so it can connect two probes at the same time.
Press PROBE-key to back to Transducer Selection interface.
1: Select the proper probe.
2: Select the proper Application.
3: Double click the preset to enter into the default preset, or click the user defined preset at the bottom of this
interface.
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Fig. 4-1
4.2.2. Patient Data Entry
Press the PATIENT-key to display the Patient interface.
Fig. 4-2
Method of entering the patient information
1) Move the cursor to input area and input the patient information through the keyboard. Move trackball to
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exchange between each option. E.g., patient name, birthday (birthday result will be automatic calculated
after entering the age), age (age result will be automatic calculated after entering the birthday), sex, weight,
height.etc.
2) Click OK key to save the data after entering the appropriate information, then the system will go back to B
mode.
4.2.3. Display Interface
Fig. 4-3
image parameter area: Display the parameters under current mode. The different modes have different parameters.
thumbnail area of saving images This area displays the thumbnail images of current patient. Selecting
thumbnail images can recall this image immediately.
shortcut key SK1SK5 SK1SK5 is corresponding to the menu of NO.1-NO5. Press the shortcut key to
select the function in the first line. Rotate the shortcut key can adjust the parameters in the second line.
Patient Patient Application/ Hospital Data
Name ID Preset Name Probe Time
Operation
note area
Shortcut key: SK1-SK5
thumbnail
area of
saving
images
image
paramet
er area
40
operation note areaThe first line shows the status of the current system. The second line indicates the current
function of the trackball. In the picture Fig. 4-3, the first line display freeze menu. It means the system is in
frozen status. The second line display recall image. It means moving the trackball can recall the images in
current status.
system information area Display the current system information. Moving the mouse to different icon will
display detailed information accordingly.
Display current network situation. It will display the IP address after connecting to the network.
Display the status of current removable disks. If exist removable disks, click this icon can quickly
enter into the storage manager interface and do the operation for disks.
Fig. 4-4
Display space size of all the drivers.
Printer management, refer to section 7.6
Task manager: display the state of current task
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Fig. 4-5
Switch input language
4.3. Optimizing the Image
4.3.1. Image Parameters Display
B Meaning CFM/PD Meaning PW Meaning M Meaning
Freq. Frequency Freq. Frequency PRF PRF SR
Sweep
Speed
FPS Frame rate PRF PRF WF Wall Filter
D/P
D: Dynamic
range
P: Persistence
WF Wall Filter GN Doppler Gain
GN B Gain GN Color Gain DA Doppler angle
AP
Acoustic
power
C/P
C: Color map /direction
power P:Persistence
SV
Sample volume
gate
D Display depth
4.3.2. Scanning Modes
The system can support the following modes:
B2DMode
2B Mode
4B Mode
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B/M Mode
M Mode
PW Mode
CW Mode
CFM Mode
CPA Mode
B/BC Mode
Steer M Mode
Color M Mode
HPRF Mode
Panoramic Imaging Mode
TDI Mode
4.3.3. B Mode
Intended Use:
B-mode is intended to provide two-dimensional images and measurement capabilities concerning the
anatomical structure of soft tissue. Press B -knob to enter into B mode. Rotate B-knob to adjust B gain.
Fig. 4-6 B Mode
4.3.4. Dual Mode
In B mode, press key .System will and display the current image at the left side of the screen, Press
43
key second time, system will freeze the image displayed at the left side and activate the image displayed
at the right side at the same time. Press key continuously to achieve exchange of the freeze/real status
between left side image and right side image. Use the key to invert image which is activated in left and
right direction. Use the key to invert image which is activated in left and right direction.. Press
key to go back to B mode.
NOTE:
There is only one image could be activated
Dual display is also available for the Color Mode
Fig. 4-7 B/B Mode
4.3.5. Quad Mode
In B Mode, press key, the image which is activated will be displayed at the upper left side of the screen,
press key continuously will freeze and activate the upper right image, lower left image, and lower right
image in order. Use key do the Left/Right invent for current archiving image, use the key which on
the control panel can do the up/down invert for current achieving image. It will go back to B Mode if press [Single
mode] key again.
NOTE:
There is only one image could be activated at one time
Quad display is also available for the Color Mode.
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4.3.6. B/BC Mode
In active color mode, turn the [B/BC] item on to display a real B mode image at the left side of the screen and
active Color mode image at the right side of the screen.
4.3.7. B/M and M Mode
Intended Use:
M-mode is used to determine patterns of motion for objects within the ultrasound beam. The most common use
is for viewing motion patterns of the heart.
This system provides B mode image and M mode image at the same time. Press M knob to enter into B/M mode.
Press M knob again to enter into M mode. M mode is fit for heart scanning and measurement.
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Fig. 4-8 B/M Mode
M-mode Exam Procedure:
Get a good B-mode image. Survey the anatomy and place the area of interest near the center of the B-mode
image.
Press the M-knob, move the Trackball to position the M cursor over the area that you want to display in M-
mode.
Adjust the Sweep Speed, TGC, Gain etc, as needed.
Press the FREEZE-key to stop the M scanning.
Record the image to hard disk or to the printer (hard copy device).
Press FREEZE-key to continue imaging.
Press M-knob to enter into M-mode.
Press M knob again to exit M-mode.
M-mode Scanning Hints:
Sweep speed: control speed of M-mode update.
4.3.8. Steer M mode
Steer M mode is only available on phased array probe. This mode can give you the ability to manipulate
the cursor at different angle and position. The M-mode display changes as per the M cursor position.
User can activate the Steering M mode using Soft-Menu. Turn the item Steering M on, and turn Angle to rotate
Steering M line .The system provides maximum 3 Steer M line and you can select either of them with SET-key.
46
Trackball: used to move the Steer M line.
Angle: used to rotate the Steer M line.
4.3.9. CFM mode
Intended Use:
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. [STEER] button is used to adjust the
angle of color sampling box (if current probe is linear probe). Press ENTER-key to fix 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 knob to enter into CFM mode; after C knob light is on, rotate the 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.
47
Fig. 4-9 CFM Mode
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
Persistence: affect temporal smoothing and color Doppler robustness.
Line Density: trade frame rate for sensitivity and spatial resolution. If the frame rate is too slow, decrease the CROI
size and the line density.
4.3.10. PD (CPA) 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.
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Fig. 4-10 PD Mode
Press CPA -key to enter into the CPA mode and then CPA lights is on
Direction PD mode
In Power DopplerCPA) mode, press MENU -knob to pop up the PD Menu . Rotate MENU- knob to select the
PD (CPA) 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.
4.3.11. 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-knob to
enter Color M mode.
4.3.12. PW mode
Intended Use:
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
49
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-mode image.
Fig. 4-11 PW Mode
PW mode Exam Procedure:
Get a good B-mode image. Press C-knob to help locate the vessel you wish to examine.
Press PW-knob 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 FREEZE-key to hold the trace in cine memory and stop imaging.
Perform measurements and calculations, as necessary.
Record results with your recording devices.
Press FREEZE-key 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.
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Doppler mode Scanning Hints:
The best Doppler data will be got when the scanning direction is parallel to the direction of the blood flow; when
the scanning direction is perpendicular to the anatomic target, you can get the best B mode image, so you should
keep the balance as you dont usually get both an ideal B-mode image and ideal Doppler data simultaneously.
PRF: adjust the velocity scale to accommodate faster/slower blood flow velocity. Velocity scale determines pulse
repetition frequency.
Wall Filter: remove the noise caused by vessel or heart wall motion at the expense of low flow sensitivity.
Baseline: adjust the baseline to accommodate faster or slower blood flows to eliminate aliasing.
Angle Correct: optimize the accuracy of the flow velocity. It estimates the flow velocity in a direction at an angle
to the Doppler vector by computing the angle between the Doppler vector and the flow to be measured. This is
special useful in vascular applications where you need to measure velocity.
Doppler Gain: allow you to control the background information of spectral.
Sweep Speed: control speed of spectral update.
Doppler Sample Volume Gate Position and Size (Trackball and SET)
Move the sample volume on the B-modes 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 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.
Activating Triplex mode
While in B mode, press C-knob and D-knob to access the B+Doppler+Color mode, turn triplex menu on,
press the UPDATE-key to enter the Doppler active mode.
While in B mode, press CPA-key and D-knob access the B+Doppler+PD mode, turn triplex menu on, press
the UPDATE-key to enter the Doppler active mode.
4.3.13. 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.
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4.3.14. HPRF Mode
High Pulse Repetition Frequency (HPRF) is a special operating mode of PW Doppler. In HPRF mode,
multiple energy pulses are used. This allows higher velocities to be detected without causing aliasing artifacts.
HPRF mode is used when detected velocities exceed the processing capabilities of the currently selected PW
Doppler scale or when the selected anatomical site is too deep for the selected PW Doppler scale.
HPRF is invoked when you are operating in PW Doppler mode and conditions activate HPRF when the
velocity scale factor or sample volume gate depth exceeds certain limits. When HPRF is active, multiple sample
volume gates appear along the Doppler cursor. Doppler information can be received from any of the multiple
sample volume gates. The Doppler signals from all the gates are added together and displayed in one spectrum.
It works with a phased array or pediatric probe.
4.3.15. Panoramic
Moving through the probe to get a series of B-mode images, Press Freeze key and turn the menu on, select Image
Stitch item, turn it on. The system will enter into panoramic mode.
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4.3.16. Elastography mode
Ultrasound elastography is a new ultrasound technology to study traditional ultrasound can not detect tumors and
spread of disease imaging, can be applied to the breast, thyroid, prostate and other aspects.
In B mode, turn elastography menu on can enter into elastography mode.
4.3.17. Optimize Image
Methods for optimizing
1. Use soft menu
Press MENU- knob under the display mode and tune out the soft menu. Press Change key now can do the exchange of
the menu to different exam mode. Rotate MENU- knob to select the menu items. Press MENU- knob to enter. Now
rotate MENU -knob can change the parameter of selected item. After adjustment, press Menu-knob to exit from
selected item, at this time rotate the Menu-knob can select the item again. Select the EXIT icon or press Menu-knob
to exit from the menu.
2. Use shortcut menu
SK1SK5 shortcut key respectively corresponding NO.1NO5 menu. Press shortcut key will choose the menu
53
function for the first line; rotate shortcut can adjust parameters for next line.
3 Use other keys
4.3.18. Image Optimization of B Mode
Soft menu adjustment
Menu Function Menu Adjustable Range
Scan width
Adjust scan width of B image; frame rate will be fast if scan width is
small.
6% to 100%
Image Rotate
Change the direction of B image. The angle will be increased at 90
interval in clockwise direction
Invert angle: 090
180270.
Gamma Adjust gamma value. 0~8 rank adjustable.
Smooth Adjust the image smooth. 0~7 rank adjustable.
Edge enhance Adjust edge enhance. 0~6 rank adjustable.
Apower Adjust acoustic power. 0-100%
Trapezoidal
Mode
Turn on Trapezoidal Mode On/Off
Biopsy Turn on the biopsy function
Elastography Turn on Elastography Mode On/Off
B Steer Adjust the steer angle of B image
Multi-angle adjustable, only
support linear probe
ECG Turn on ECG On/Off
Brightness Adjust brightness of LCD monitor 0-100%
Utility
Shortcut adjustment
Shortcut
Action
Menu Menu function Adjustable range of menu
SK1
press
frequency Adjust frequency of the probe. Relate to current probe.
SK1
rotate
dynamic
range
Adjust the image dynamic range,
increase or decrease, System dynamic
range and contrast resolution.
multi-step adjustable
SK2
press
Focus
Numbers
Changes focus numbers.
1~4 adjustable, relate to the probe type and
depth.
SK2 Focus Changes focus position.
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rotate position
SK3
press
Compound
imaging
Open compound imaging On, Off
SK3
rotate
i-Image Open optimizing image multi-step adjustable
SK4
press
SRA Open SRA
It can be on or off while COMPOUND is
off.
SK4
rotate
Persistence
Increase/decrease the contrast
resolution of the image
0~7 grade adjustableclockwise for
increasing, anticlockwise for decreasing.
Adjust range: 1.
SK5
press
Density Change the image density High and Low adjustable
SK5
rotate
Noise reject Adjust the image noise suppression
Adjust range: 0-255clockwise for
increasing, anticlockwise for decreasing.
Adjust range: 1.
Other adjustments
1 DepthDEPTH toggle key
DEPTH toggle key is used for the adjustment of image depth. Depth will increase if adjust downward; Depth
will decrease if adjust upward. For the best resolution of focusing and edge enhancement, it needs to adjust
TGC after the depth has been adjusted.
2 Focus controlFOCUS toggle key
Add a specific area to achieve the decomposition of image focusing optimization. Increase focusing
numbers or move focusing position could increase the resolution of the special areas and strengthen
scanning of special areas.
Adjust FOCUS toggle key could do up/down movements for launching the focusing position.
NoteChange focus numbers will affect the frame rate. Frame rate will be slow if focus numbers are
increased.
3 Scanning directionleft/right invert key, up/down invert key
Under the single display mode, the scanning direction will be left/right inverted if press the left/right invert
key; images scanning direction will be up/down inverted if press U/D key.
4 GainB knob
Adjust gain of B mode could enhance or reduce quantities of echo information in images. Adjust the main
55
gain can adjust sensitivity of overall images (brightness). Rotate the knob of B mode could adjust B gain after
the B light is on. The gain will be increased if rotate clockwise; the gain will be decreased if rotate contra.
Adjust range is from 0 to 255. TGC will influence on each other between gain adjustment and TGC
adjustment.
5 TGC
TGC with 8 adjustable slides: Slide the set of slider bars can change the depth gain of 2D images.
TGC returns signal amplifier to correct for the attenuation caused when adding depth. TGC balance the image
and make the density of echo uniformly distributed in images. Similarly the enlargement of every sliding
channel area is also different.
The range of TGC will redistribute according to the new depth while depth is changing.
Move the slide bar Left/Right can reduce/increase TGC.
6 Image magnification ZOOM -knob
Press ZOOM- knob, press UPDATE-key to choose the size of ROI box ,and then press UPDATE-key again to
choose the position. Press ENTER- key can realize multiple enlargements. Press EXIT-key or ZOOM knob to
exit operation.
4.3.19. Image Optimization of M mode
Shortcut menu adjustment
Shortcut Menu Menu Function Menu item adjustable rang
SK1
(rotate)
Color
Map
Adjust the color of
the M image
Adjust option:user,type1~9
SK2
rotate
Speed
Adjust scanning
speed
1234 adjustable. adjust clockwise, the numerical increase and
adjust anticlockwise,the numerical decrease. Adjust range: 1.
SK5
(press)
Layout Adjust layout UD, LR
4.3.20. Color Flow Map(CFM) Mode image optimization
MENU Menu Function Menu Item adjustable Rang
Color Mode The way of selecting color Velocityvariance
Packet Size Adjust the value of packet size 6~15
Wall Thre Adjust wall threshold 0~15
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Blood Effection Choose different blood effection Smooth, HighRes
Shortcut Adjustment
Shortcut
action
Menu Menu Function Menu Item adjustable Rang
SK1
press
Frequency
Adjust the frequency of
probe
Refer to current probe
SK1
rotate
Steer
Adjust angle of sampling box
of blood flow under the linear
probe
Adjust range from -20 to 20
SK2
press
Wall Filter Change of Wall filtering 0~3 adjustable
SK2
rotate
Color Map Change of Color Map Adjust option:User, Type:1- 9
SK3
press
Flow Change sensitivity of blood High, Middle and Low for option
SK3
rotate
PRF Adjust PRF value
The maximum PRF depends on the probe and the
position of sampling box.
SK4
press
Invert Realize invert of blood flow Turn on or Turn of the invert
SK4
rotate
Persistence Improve the current color 0~7 grade adjustable. Adjust range: 1.
SK5
press
Density Change images density High and Low adjustable.
SK5
rotate
Baseline
Change the baseline of color-
map
-3~3 adjustable.
Other adjustments
1 CFM gain control.
Rotate C- knob after C lights is on .Adjust the color gain and adjust range is from 0 to 255.
2 Sampling box.
Moves sampling box through trackball to the area which you are interested and press the ENTER- key to confirm the
position of sampling box then adjust the size of box trough trackball and press ENTER- key to confirm.
Use the STEER toggle key to change the direction of sampling box under the linear probe.
57
4.3.21. Power Doppler(CPA) Mode imaging optimization
MENU Menu Function Menu ItemAdjustable Rang
Packet Size Adjust the value of packet size 6~15, adjust range: 1
Wall Thre.
Adjust wall threshold
0~15, adjust range:1
DPD Mode Exchange PD Mode and DPD
Mode
Press it can exchange between PD Mode and
DPD Mode
Shortcut Adjustment
SK1press Frequency Adjust the probe launch
frequency
Refer to current probe
SK1rotate Steer Adjust angle of sampling box
of blood flow under the linear
probe
Adjust range from -20 to 20,
SK2press Wall Filter Change of Wall filtering 0~3 adjustable
SK2rotate Color Map Change of Color Map type 1 ,user
SK3press Flow Change sensitivity of blood High, Middle and Low for
option
SK3rotate PRF Adjust PRF value The maximum PRF depends on
the probe and the position of
sampling box.
SK4press Density Change images density High and Low adjustable
SK4rotate Persistence Improve the current color 0~7 grade adjustable, adjust
clockwise, the numerical
increase and adjust
anticlockwise, the numerical
decrease.Adjust range: 1.
Other adjustments
1 CPA gain control.
Rotate C knob after CPA light is on then adjust the gain and the range is from 0 to 255.
2 Sampling box.
Moves sampling box through trackball to the area which you are interested and press the ENTER- key to confirm the
position of sampling box then adjust the size of box trough trackball and press ENTER- key to confirm.
Use the STEER toggle key to change the direction of sampling box under the linear probe.
58
Note: this function can only support linear probe.
4.3.22. Pulse Wave Doppler Imaging Optimization(PWD)
2D Map Adjust the color of spectrum 1~6, adjust range: 1
Spectrum Enhance Adjust the brightness of the
spectrum
0~3, adjust range:1
DynamicRange Adjust the dynamic range of the
spectrum
46~67
Triplex turn on/off triplex mode turn on, turn off
Auto Cal Parameter set the auto Calc parameters
DTrace Smooth Adjust the smooth of the trace
of the spectrum
0~3, adjust range:1
Threshold Adjust the threshold of the
spectrum
1~5, adjust range:1
Trace Area set the auto cal range above, below, all
Shortcut adjustment
Shortcutaction Menu Menu Function Menu ItemAdjustable Rang
SK1press Invert Spectrum invert Turn on or Turn off the invert function
SK1rotate Color Map Adjust the color map of
spectrum
Adjust options:user,type1~9
SK2press Wall Filter Change of wall filtering 0~3 adjustable
SK2rotate Audio Adjust volume of Doppler 0~100% adjustable.
SK3rotate PRF Adjust PRF value The maximum PRF value depends on
the probe and the position of sampling
gate.
SK4rotate Speed Adjust scanning speed 123 adjustable. adjust clockwise,
the numerical increase and adjust
anticlockwise, the numerical decrease.
Adjust range: 1
SK5rotate Baseline Adjust the baseline
position
0~6 adjustable.
59
Other adjustments
1 PRF
Hold faster or slower blood flow through rate adjustment. PRF toggle key is for adjusting the value of PRF
and the maximum PRF value depends on the probe and the position of sampling gate.
2Sampling line
In PW mode, move the trackball left and right to adjust the position of sampling line
3Sampling gateSampling volume
Move the sample volume on the B-modes Doppler area. The gate is positioned over a specific position
within the vessel.
To move Doppler line position, move 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
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.
4Gain
Rotate PW knob and adjust gain of PWD mode when PW light is on. Gain will be increased if rotate
clockwiseGain will be decreased if rotate anti-clockwise. Adjustable range is from 0 to 255.
4.3.23. Continuous Wave Doppler Imaging Optimization(CW)
2D Map Adjust the color of spectrum 1~10, adjust range: 1
CWDFET Adjust the CWDFET of the
spectrum
0~15, adjust range:1
CWDEnhance Adjust the enhance of the CW
spectrum
0~7,adjust range:1
Dynamic Adjust the dynamic range of the
CW spectrum
45~80,adjust range:5
Shortcut adjustment
Shortcutaction Menu Menu Function Menu ItemAdjustable Rang
SK1press Invert Spectrum invert Turn on or Turn off the invert function
SK1rotate Color Map Adjust the color map of
spectrum
Adjust options:user,type1~9
SK2press Wall Filter Change of wall filtering 0~3 adjustable
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SK2rotate Audio Adjust volume of Doppler 0~100% adjustable.
SK3rotate PRF Adjust PRF value The maximum PRF value depends on
the probe and the position of sampling
gate.
SK4rotate Speed Adjust scanning speed 123 adjustable. Adjust
clockwise, the numerical increase and
adjust anticlockwise, the numerical
decrease. Adjust range: 1
SK5rotate Baseline Adjust the baseline
position
0~6 adjustable.
Other adjustments
1 PRF
Hold faster or slower blood flow through rate adjustment. PRF toggle key is for adjusting the value of PRF
and the maximum PRF value depends on the probe and the position of sampling gate.
2Sampling line
In PW mode, move the trackball left and right to adjust the position of sampling line
3 Gain
Rotate PW knob and adjust gain of CWD mode when CW light is on. Gain will be increased if rotate
clockwiseGain will be decreased if rotate anti-clockwise. Adjustable range is from 0 to 255.
4.3.24. 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.
The ECG control is in the soft-menu available for the cardiac probe, it allows the user to set up the following
control:
ECG ON/OFF: turn on/off the ECG trace
ECG Invert: turn on/off the ECG invert
ECG GAIN: increase or decrease the ECG gain
ECG POS: set the ECG trace position
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ECG Velocity: set the ECG Velocity
4.4. After Capturing the Image
4.4.1. Adding Comments
Comment means input the words or symbols on images for making explanation. Add comments can through
keyboard input directly or using the default comments.
Input characters
Operation
1. Press [COMMENT] key will display on the screen, and then system will go into the comment
process.
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 COMMENT-key or EXIT- key to exit. The COMMENT-key will light off and the comments
process is finished.
Edit custom comments bar
Operation
1 Press [COMMENT] key to enter into comments status.
2Press SK4 key to select the comment bar.
3Edit comments for text1~text6.
4Press OK key to save changes or press [CANCEL] key to cancel revises.
NoteThe user can edit 6 customized comments.
Add comment note on images
Operation
1 Press [COMMENT] key to enter into the comment status.
2 Rotate SK1 key to select the comment note.
3 Press SK1 shortcut key to append the selected comment bar.
4 Press [COMMENT] key, the [COMMENT] key will light off and the comment process is finished.
Adjust font size of comments
Operation
1 Rotate SK2 in comment status.
2 Move the cursor to the comment note. Press [ENTER] key and choose the font size of comment note.
Press [ENTER] key again to confirm revision.
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Adjust position of comments
Operation
1 In comments status, moves the cursor to comments note which need to be changed then press
[ENTER] key.
4.4.2. Adding Body Mark
Operation
1 Press BODY- key to enter into the body status.
2 Press SK.1~ SK.5 shortcut key to add body image accordingly. Rotate SK.5 shortcut key can realize page
turning.
3 Move trackball after adding the body mark image and then adjust the position of probe. Rotate [ANGLE] key
can adjust the probe direction. Press Enter- key to confirm when adjustment was finished.
4 Press UPDATE-key and move the Trackball to change the position of the body mark
5 If you want to exit from the body mark function, press BODY-key or EXIT-key
Delete comments, body marks and measure tracks.
Press DEL- key to delete all commentsarrowsbody marks and measure tracks in frozen status.
4.4.3. Saving Still Images
Save single imagePress key to save the single image in the real time and frozen statue. The saved
thumbnail images will be displayed under the image area for users to choose playback or post-processing
quickly.
Re-call single imagePress arrow key in re-call status, then the mouse will appear on the screen. Move the
mouse to thumbnail images then click.
4.4.4. Saving Clips
Save forward cine filesPress key in the real time to save forward cine files.
Save backward cine files: Press key in frozen statue to save backward cine files.
The saved cine images will be displayed under the image area for users to choose playback or post-processing
quickly.
Playback cine filesPress arrow key in recall status, then the mouse will appear on the screen. Move the
mouse to the cine thumbnail image then click.
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Shortcut
Action
SK1 SK2 SK3 SK4
Press
Play or Pause
cine playback
Set the initial
point of
playback
Set the final
point of
playback
Reset the range of cine
playback,the default range of
playback is 1-maximum
frame of current cine
Rotate
Adjust the
playback
speed of cine
The frame of
start position
The frame of
final position
Manual playback cinePress arrow key and back to recall status then manual playback through trackball.
Note: When you save the still images or cine images, if you do not establish a new patient, the system will
establish a new ID according to the current date of the system automatically and save the data and operation
under the folder of this ID.
Quick transmission of image:
Image transmission: Press arrow key. Choose the image which you want to transfer or delete, and press Update
key. Three icons will display in the thumbnail area.
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Transfer files to DICOM.
Transfer files to media.
Delete the files.
4.4.5. Browse Images
Press key to enter into the browse interface.
Infopress this key can check the information of current patient.
Reportpress this key can see the report of current patient
Closeclick this key and choose to close information of patient.
Close allclose all current patients.
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Continue/Edit Examcontinue to check the current patient and back to B mode if press this key. If current exam is
24 hours later than last exam, the system will not allow you to continue the exam. The function will be changed to
Edit
New Studycreate a new patient, then the system will automatically go to this new page.
Archive: Pop up Files Management interface. Multiple patients can be compared and browsed
CancelExit.
4.4.6 Fast Storage
Setting: Enter into System Settings . Press General Menu and choose Normal Sub Menu to do fast storage setting.
After confirming time, back to examination.
For example, choose 5 seconds in the fast storage setting. The system begins to save cine in the 5 seconds after
press .
If you choose Manual in the fast storage setting, you should press for two times. First time is to start
saving and the second time is to finish .
If you choose Export to removable media, it will save the images to the removable media.
4.4.7. Files Management
In this interface you can manage patient's files. Press key to enter into the browse interface. Then click
Archive to enter into file management.
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Search: Can search the patient files after enter a search term. Search will be more accurate when input more conditions.
InformationView the selected patient information.
BackupClick this item will store the database of this patient to the portable storage medium
Recover: Click this item can recover the images or video from USB to the system
Send toSelect the content and click, can send files to other medium.
Deletecan delete patient's files, images etc.
Select allSelect all the patients.
Patients viewUnder this view, one patient with multiple inspection data will be listed in column and also you can
check each exam file in details.
Study viewThis view can list exam types one by one. Different exam type of one patient will not be listed in one
column.
New studyCreate a new patient and recall into the patient information interface.
Continue/Edit ExamContinue to check the current patient and back to B mode if press this key. If current exam is 24
hours later than last exam, the system will not allow you to continue the exam. The function will be changed to Edit.
ReviewSelect patient and click it to enter into images browse.
CancelClick Cancel to exit.
4.4.8. Network Storage Function
Before you use this function, please refer to Section 7.5 to set network storage parameters.
Click button to enter into the Easy Review interface, select the picture you want to send, click to
enter into the export interface, select the network drive and click "OK" to send.
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After transmit into the target computer, open the shared folder, you can see the pictures you sent.
4.4.9. DICOM Function(Option)
The system support DICOM storage, DICOM print, MPPS, WORKLIST, DICOM SR storage.
1. Connect the machine into LAN before setting the DICOM
2. Enter into DICOM Setting interface.
Press Utility key to enter into system setting interface. Press DICOM page to enter into DICOM interface.
Note:
If the DICOM function is not open, the system setting interface will not display DICOM page.
Please make sure the DICOM function is open before you use DICOM function.
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Add: Press this icon to add a DICOM service link
Modify: Select the DICOM link which need to be modified. Press this icon to modify the parameters inside.
Delete: Select the DICOM link which needs to be deleted. Press this icon to delete the DICOM link.
Verify: Select the DICOM link which need to be verified. Press this icon to verify the current DICOM link status.
Default: If there are several service links of same type, you can select one of them as the default one.
3. DICOM storage
DICOM storage parameters setting
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Service: Click the drop list to select storage function.
AE title: Name the server at will
Host: Set the IP of the service host
Port: Make the port of the work station the same as the port of the server.
Alias: The name of current link
Time out: time delay
Mode: batch, follow, manual selectable
Batch: all the saved images in current exam will be sent to the server in one time
Follow: When one image is saved, the system will send this image to the server.
Manual: The user has to select the image by manual.
After all the settings are completed, please click OK to save current setting. Click clear to clear all the setting.
Clicking cancel will not save the current setting.
DICOM storage
Batch mode: In batch mode, when the patient finishes his exam, press End key to end the current exam. All
the saved images will be saved as DCM format and sent to the server automatically.
Follow: In follow mode, during the exam, press key to save the image. The current image will be
saved as DCM format and sent to the server.
Manual: In manual mode, the user has to select the image by manual and do DICOM transfer. Press
key to enter into review interface. Select the images need to be sent, press key to send.
4. DICOM print
DICOM print parameters setting.
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Service: Click the drop list to select print function.
Host: Set the IP of the server
Mode: batch, follow, manual selectable
Batch: all the saved images in current exam will be sent to the server and printed automatically in one
time
Follow: When one image is saved, the system will send this image to the server and print it.
Manual: The user has to select the image by manual and print it.
After all the settings are completed, please click OK to save current setting. Click clear to clear all the setting.
Clicking cancel will not save the current setting.
DICOM print
Batch mode: In batch mode, when the patient finishes his exam, press End key to end the current exam. All
the saved images will be saved as DCM format and sent to the server automatically to be printed.
Follow: In follow mode, during the exam, press save key to save the image. The current image will be saved
as DCM format and sent to the server to be printed.
Manual: In manual mode, the user has to select the image by manual and do DICOM transfer. Press browse
key to enter into review interface. Select the images need to be sent, click icon to print.
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5. DICOM Worklist
DICOM Worklist parameters setting.
Service: Click the drop list to select worklist function.

For Update Method parameter group, the worklist update can only started by user request for Only on user request,
or user can set N(1~60) minutes to update worklist automatically for On Startup and Every X minutes.
For Scheduled Station AE Title parameter group, the schedule station AE title, which is one of a matching key, will
be set to blank for Any, LocalAE for This System or user customized string for Another. And only the
matched items will be queried for each worklist update.
For Start Date parameter group, it is the matching key for Scheduled Procedure Step Start Date, and there are five
Start Date types to select.
DICOM Worklist
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Press the keyboard button shaped as , and press Worklist
Press Search to start a worklist update by the matching key specified in Worklist Configuration, all the matched items
will be queried in worklist table. User also can add additional for matching keys, which are PatientID, PatientName,
Accession# and ProcedureId , for a more precise query.
Select one matched item and press Apply for the current exam application. At this moment, a MPPS service will be
started which will be introduced in MPPS section.
6. DICOM MPPS
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Service: Click the drop list to select MPPS function.
Applying the selected worklist item will result in automated creation of an MPPS instance.
Completion of the MPPS is performed by pressing the keyboard shaped as .
7. DICOM SR Storage
Service: Click the drop list to select SR Storage function.
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Time out: time delay.
Only OB/GYN and Cardiac report support this server.
After finishing OB/GYN or Cardiac measurements, press report key to create report for current exam. When the patient
finishes his exam, press End key to end the current exam, the SR report will be sent to the server automatically.
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Chapter 5 General Measurements
Introduction
Measurements and calculations derived from ultrasound images are intended to supplement other clinical
procedures available to the physician. The accuracy of measurements is not only determined by system accuracy,
but also by the use of proper medical protocols by the operator. When appropriate, make sure to note any
protocol associated with a particular measurement or calculation.
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
operators experience, patients 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.
Overview
This section provides information about taking measurements and describing calculations available in each mode.
It includes the following topics:
List of generic measurements
Mode Measurements: Step-by-step instructions for taking specific measurements, organized by mode
Measurement results display and erasing
5.1 Key for Measurement
Trackball
Trackball is used to move the cursor, main functions are as follows:
Before starting a measurement, use the trackball to choose the menu options;
After starting a measurement, move the trackball to move the cursor, during the measurement, the cursor
should not be moved out image area;
During the Ellipse method measurement, use trackball to change the length of short axis.
ENTER
During the measurement, the functions of ENTERkey are as follows:
When cursor is on the menu, press the key to choose the options and start the measurement.
During the measurement, press the key to anchor the start point and end point.
DEL
Main functions are as follows:
In frozen status, press the DEL-key, delete all the measurement results, comments and traces.
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UPDATE
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.
During the distance measurement, press theENTERto fix the start point, when the end point is not
fixed, press the UPDATE-KEY to switch the start point and end point.
During the Ellipse measurement, when fix the long axis, but the short axis is not fixed, press the
UPDATE-KEY to switch the long axis and short one.
5.2 Fast measurement
The system use Dist,Trace,SK1~SK3 to make fast measurement. In different modes, SK1~SK3 is corresponded
to different measurement items. Users can rotate SK1~SK3 to choose the measurement items during the
measurement.
5.2.1 Enter fast measurement
Press Dist or Trace to enter fast measurement
Dist: distance measurement
Trace: Area measurement
5.2.2 Exit fast measurement
During measurement, press the Dist key for second timeor press Trace-key or Exit-key.
5.2.3 Fast measurement in B mode
SK1-distance: distanceDistance ratio, angle
SK2-area: trace methodEllipse methodarea ratio
SK3-volume: 1 distance method1 Ellipse method1 Distance1 Ellipse method2 Distance method
2 Ellipse method3 Distance method
SK4-Font Size: Rotate to adjust the font size, Press to reset.
SK5-Result Position: Rotate to move result position, Press to reset
Distance
1) In B Cine mode, press the DIST-key to bring up the first white plus sign (+) cursor.
2) Use the Trackball and the ENTER-key to anchor the start point of the desired distance to be measured.
3) Move the Trackball and a second white plus sign cursor will automatically appear. Move the second cursor
to the s1pecified position. With the movement of cursor the system will update the measurement distance in
real time in Result Window on the right side of the screen.
4) Press the ENTER-key to fix the second cursor, the first measurement result will appear on the screen.
5) When two points have been defined, a white plus sign cursor of next distance pair will pop out. Repeat the
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same steps to create other distance pairs
6) Press the DIST-key or EXIT-key to exit.
Distance ratio
In B mode, press the DIST-key to bring up the first white plus sign (+) cursor.
Rotate SK1,choose %stD
Refer to the distance measurement method, measure the distance of second line.
After finishing the measurement, the distance of the two lines will appear automatically on the screen and
calculate the ratio of the two lines automatically.
Areatrace
1) In B mode, press the TRACE-key to bring up the trace start cursor plus sign (+).
2) Use the trackball to move the cursor, press ENTER-key to set the start point.
3) Use the Trackball to trace the perimeter of the object to be measured, and press the Enter-key to set the end
point. The end point and the starting point of the trace will be automatically connected with a straight line .The
area and the Circumference of the shape will be calculated. With the movement of the cursor, the result will
appear on the right side of the screen, and will change along with the moving of the trace.
4) To get the multiple data, repeat the same steps to create other distance pairs.
5) Press the Trace-key or EXIT-key to exit.
Areaellipse
2) Rotate SK2choose ellipse.
3) Move the Trackball and press ENTER-key to set start point
4) The second point marker is displayed by a line connecting the first and second points. Use the Trackball to
lengthen the line in order to change the diameter and press the ENTER-key to fix the length.
5) Use the Trackball to change the length of another axis.Press the ENTER-key to fix the length. The total area
and circumference will be displayed in the result window.
7) Press the Trace-key or EXIT-key to exit.
Area ratio
2) Rotate SK2choose %stA.
3) Refer to the area-ellipse method to measure two ellipses.
4) After finishing the measurement, the area of the two lines will appear on the screen, and the area ratio will be
calculated automatically.
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Volume1 straight line
1) In B mode, press the distance-key or trace-key to enter the measurement mode.
2) Press SK3-key to enter volume measurementthe default measurement method is 1 straight line.
Volume1 ellipse
3) Rotate SK3-keychoose 1 ellipse.
Volume1 straight line 1 ellipse
3) Rotate SK3-keychoose 1straight line 1 ellipse.
3) Rotate SK3-keychoose 2 straight line.
Volume2 ellipse
1) In B Cine mode, press the distance-key or trace-key to enter the measurement mode.
3) Rotate SK3-keychoose 2 ellipse.
1) In B Cine mode, press the distance-key or trace-key to enter the measurement mode.
3) Rotate SK3-keychoose 3 straight line.
5.2.4 Fast measurement in PW mode
SK1-distance: distancepeak, HR, Angle
SK2-area: automatic envelopemanual envelopetraceellipseratio
SK3-volume: 1 straight line.1 ellipse1 straight line 1 ellipse2 straight line2 ellipse3 straight line
SK4-Font Size: Rotate to adjust the font size, and press to reset.
SK5-Result Position: Rotate to move result position, and press to reset
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Peak
1) In PW Cine mode, press the Dist-key to bring up the sample marker.
2) Move the marker to the measurement start point with the Trackball, press Enter key, velocity and pressure of
the current point will appear on the screen automatically.
3) Go on to measure Vd, after getting the result, the system will calculate S/D, RI, heart rate automatically.
Automatic envelope measurement
1) In PW mode, press the Trace-key to enter automatic envelope measurement. The system will finish the
envelope of spectrum automatically. The cursor+will appear on the screen
2) Move the trackball to choose a start point of one cycle, press the Enter-key to confirm
3) The second cursor+will appear on the screen automatically, move the trackball to the end point of current
cycle, and press the ENTER-key to set.
4) The measurement result and the other calculated parameters will appear on the screen automatically.
5) If the spectrum automatic envelop is not accurate, rotate SK4 and reselect cycle to correct.
Manual envelope
1) In PW Cine mode, press the Trace-key to enter automatic envelope measurement.
2) Rotate SK2choose Manual envelope.
3) Move the trackball to choose a start point of one cycle, press the Enter-key to confirm.
4) Move the trackball to trace the spectrum, press the ENTER-key to finish the envelope..
5) The measurement results and the other calculated results will appear on the screen automatically.
6) If the spectrum manual envelop is not accurate, rotate SK5 and restart to manual envelop.
5.2.5 Fast measurement in M mode
SK1-distanceM DistanceM Time, M Speed, Heart Rate, Distance Ratio
SK2-areatrace methodellipse method, area ratio
SK3-Volume1straight line1ellipse1 straight line 1 ellipse2 straight line2 ellipse3 straight line
SK4-Font Size: Rotate to adjust the font size, Press to reset.
SK5-Result Position: Rotate to move result position, Press to reset
M Distance
1) In M mode, press the DIST-key to enter M distance measurement. The cursor+will appear on the screen.
2) Move the trackball to move the cursor, press ENTER-key to fix it.
3) One dotted line and second cursor will appear on the screen..
4) Move the cursor by moving the trackball to the end point in the dotted line vertically, press the Enter-key to
confirm.
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5)The measurement result will appear on the screen automatically.
M Time
1) In M Cine mode, press the DIST-key to enter M distance measurement. The cursor+will appear on the
screen.
2) Rotate SK1choose M time.
3) Move the trackball to move the cursor, press Enter-key to fix it.
4) One dotted line and second cursor will appear.
5) Move the trackball to the end point in the dotted line horizontally, press the Enter-key to fix the cursor.
6) The measurement result will appear on the screen automatically.
5.3 Measurement and Calculation
There are Corresponding measurement menu in different modes. Press Calc-key to recall the measurement menu.
Press Change-key to do exchange during the measurements menus of different modes. Press Exit key to close
the measurement menu.
Move the trackball to select the measurement item on the measurement menu and do the measurement in the
image.
After finishing the measurement, press Report-key to generate the report template to view the measurement
results or print the report.
5.3.1 Measurement in B mode
Press Calc-Key to enter into measurement package menu. Press Change-Key to change measurement package .
5.3.1.1. General Measurement in B mode
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1. Distance
1) Move the trackball to move the cursor to the distance item. Press Enter-key to select it and a mark +will
appear on the screen
2) Move the trackball to anchor the first mark and press Enter-key to set it.
3) The second mark will appear on the screen. Move the trackball to place the mark to the aimed place. The
value of the measurement will be displayed on the right side of the screen and will be changed along with the
trace of the measurement.
4) Press Enter-key to fix the second mark and the measurement results will be fixed and displayed on the
screen.
6) Press Calc-key or Exit-key to exit..
2. Area(Ellipse)
1) Rotate the trackball to move the cursor to the Area (ellipse) item. Press Enter-key to select it. At this
time, a mark +will appear on the screen.
2) Rotate the trackball to anchor the first mark and press Enter-key to fix it.
3) The second mark will appear on the screen. Rotate the trackball to change the length of the long axis of
the ellipse. Press Enter-key to confirm the length.
4) Rotate the trackball to change the length of another axis of the ellipse and press Enter-key to fix it. The
value of the area and perimeter will be displayed on the right side of the screen
6) Press Calc-key or Exit key to exit.
3. Area(Trace)
1) Rotate the trackball to move the cursor to the Area (trace) item. Press Enter-key to select it. At this
time, a mark +will appear on the screen
2) Move the trackball to move the mark to the start point of the measurement. Press Enter-key to confirm..
3) Rotate the trackball to trace the edge of the aimed object and press Enter-key to fix the end point. The
second mark will appear on the screen. Rotate the trackball to place the mark to the aimed place. The
value of the measurement will be displayed on the right side of the screen and will be changed along
with the moving of the measurement
4. Volume(1distance)
Calculate the volume of the object by one line.
Volume=distance distance distance 3.1415926/6
5. Volume (1ellipse)
Through 1 ellipse measurement, calculate the volume of the object.
Volume=axis AAxis B axis B3.1415926/6
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6. Volume(2distance)
Through 2 distance measurement, calculate the volume object.
Volume =distance1distance2distance23.1415926/6 (distance1distance2)
Volume =distance2distance1distance13.1415926/6 (distance2distance1)
7. Volume(3 distance)
Through 3 distance measurement, calculate the volume of object
Volume=distance1distance2distance33.1415926/6
8. Volume(1distance1ellipse)
Through 1distance measurement and 1 ellipse measurement, calculate the volume of object.
Volume=distance axis A axis B3.1415926/6
9. Volume(2 ellipse)
Through 2 ellipse measurement, calculate the volume of the object.
Volume=d1d2d43.1415926/6
d1 and d2 are axis of ellipse1;d3 and d4 are axis of ellipse 2: d2d3d1d4,d2d3
10. Ratio
Through 2 distance measurement, calculate the ratio of the 2 distance
Ratio=distance1/distance2
11. Angle
1) Rotate the trackball to move the cursor to the Angle item. Press Enter-key to select it and d1 line will
appear on the screen
2) Rotate the trackball to move d1 and rotate the Angle button to adjust the direction of the line ,then press
Enter-key to fix it.
3) Fix other 2 lines of d2 and d3 as step2)
4) After finishing the measurement, the result of the angles named and will be displayed on the left side
of the screen. is the angle between line d1 and line d2. is the angle between line D1 and D3.
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5.3.1.2. Cardiology Measurement in B mode
1. Single Plane
This method calculates the left ventricular volumes by using the 2D-mode long-axis image.When the left ventricle is
traced and its long axis is specified on a 2D-mode cross-sectional image, this method allows the system to
automatically divide the long axis into 20 segments to calculate the volume of the left ventricle as the 2D-mode cross-
sectional image is rotated.
Calculation formula for volume
EDV= i
2
ESV= i
2
ri: Radius of the i-th circle
LVLd: Left ventricular long-axis length at end diastole
LVLs: Left ventricular long-axis length at end diastole
<<Items to be measured>>
Meas. item name Description [Unit] Meas. method
EDVA4C End-diastolic volume (A4C)[ml] Measurement (trace)
ESVA4C End-systolic volume (A4C )[ml] Measurement (trace)
<< Items to be calculated >>
Calc. item name Description [Unit] Calc. formula
SV Stroke Volume[mL] SV=EDV ESV
EF ejection fraction EF=SV/EDV
2. BiPlane
This method allows the volume of the left ventricle to be calculated by repeating Simpson SP method on two 2D-
mode cross-sectional images (two-chamber and four-chamber cross-sectional images).
Calculation is also possible for only two-chamber cross-sectional images or only four-chamber cross- sectional
images.
(1)EDV= (r2i r4i)
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(2)ESV= (r2i r4i)
r2i:Radius of i-th ellipse(2CH)
r4i:Radius of i-th ellipse(4CH)
LVLd: Length of the left-ventricular long axis at end diastole for 2CH or 4CH, whichever is longer.
LVLs: Length of the left-ventricular long axis at end systole for 2CH or 4CH, whichever is longer.
(3) EDV= 2i
2
(4) ESV= 2i
2
ri: Radius of the i-th circle(2CH)
(5) EDV= 4i
2
(6) ESV= 4i
2
ri: Radius of the i-th circle(4CH)
EDVA2C End-diastolic volume (A2C )[ml] Measurement (trace)
ESVA2C End-systolic volume (A2C) [ml] Measurement (trace)
EDVA4C End-diastolic volume (A4C) [ml] Measurement (trace)
ESVA4C End-systolic volume (A4C) [ml] Measurement (trace)
<< Items to be calculated >>
SVSimpBP Stroke Volume[mL] SV=EDV ESV
EFSimpBP ejection fraction EF=SV/EDV
3. Bullet volume
This method calculate the left ventricular volume using the 2D-mode long-axis image and the short-axis image at the
level of the mitral valve.
EDV=
ESV=
Meas. item
name
Description [Unit] Meas. method
LVAMd Left ventricular short-axis area at the level of the mitral
valve at end diastole.
Refer to Area-trace
measurement
LVLd Left ventricular long-axis length at end diastole. Refer to "Distance
Measurement
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(Distance)".
LVAMs Left ventricular short-axis area at the level of the mitral
valve at end systole.
Refer to Area-trace
measurement
LVLs Left ventricular long-axis length at end systole. Refer to "Distance
Measurement
(Distance)".
HR Heart rate Refer to "Distance
Measurement
(Distance)".
<<Items to be calculate>>
EDV End-diastolic volume [mL] EDV =(5/6.0)*LVLd *
LVAMd
ESV End-systolic volume [mL] ESV =(5/6.0)*LVLs *
LVAMs
SV Stroke Volume [mL] SV=EDV ESV
CO Cardiac output [L/min] CO=SV * HR /1000
EF ejection fraction EF=SV/EDV
4. Modi_Simpson
This method calculates the left ventricular using the 2-D mode long-axis image, the short-axis image at the level
of the mitral valve, and the short-axis image at the level of the papillary muscle.
Calculation formula for volume:
EDV=
ESV=
LVAMd Left ventricular short-axis area at the
level of the mitral valve at end
diastole
Refer to "Area/Circumference
Measurement (Area)"
LVLd Left ventricular long-axis length at
end diastole
Refer to "Distance Measurement
(Distance)"
LVAPd Left ventricular long-axis area at the
level of the papillary muscle at end
diastole
Measurement (Area)".
LVAMs Left ventricular short-axis area at the
level of the mitral valve at end
systole
Measurement (Area)"
LVLs Left ventricular long-axis length at
end systole
(Distance)"
LVAPs Left ventricular long-axis area at the
level of the papillary muscle at end
systole
Measurement (Area)".
86
HR Heart rate Refer to Heart Rate Measurement
<<Items to be calculated>>
EDV End-diastolic left ventricular volume
[mL]
Refer to << Calculation formula for
volume>>
ESV End-systolic left ventricular volume
[mL]
volume>>
SV Stroke volume [mL] SV=EDV ESV
CO Cardiac output [L/min] CO=SV x HR /1000
EF Ejection fraction [no unit] EF=SV/ EDV
5. Cube Method
This method calculates the left ventricular volume by approximating the given region to a cube.
EDV =LVIDd
3
ESV =LVIDs
3
<< Items to be measured>>
Meas. item name Description Meas. method
Diastole End-diastolic left ventricular
measurements
Refer to Measurement position
IVSTd lnterventricular septal thickness at
end diastole
(Distance)".
LVIDd Left ventricular short-axis
diameter at end diastole
(Distance)".
LVPWd Left ventricular posterior wall
thickness at end diastole
(Distance)".
IVSTs lnterventricular septal thickness at
end systole
(Distance)".
LVIDs Left ventricular short-axis
diameter at end systole
(Distance)".
LVPWs Left ventricular posterior wall
thickness at end systole
(Distance)".
[mL]
volume>>
ESV End-systolic left ventricular volume
[mL]
volume>>
CO Cardiac output [L/min] CO=SV x HR /1000
FS Fractional shortening FS=(LVIDd-LVIDs)LVIDd
6. Teichholz Method
EDV =(7*LVIDd
3
) / (2.4+LVIDd)
87
ESV =(7*LVIDs
3
) / (2.4+LVIDs)
The items to be measured, the measurement procedures, and the items to be
calculated are identical to those in subsection CUBE method.
7. LV/RV
<<Item to be measured>>
Meas. item
name
Description Meas. method
RVIDd Right ventricular short-axis diameter at end diastole Refer to "Distance
Measurement
(Distance)".
IVSTd lnterventricular septal thickness at end diastole Refer to "Distance
Measurement
(Distance)".
LVIDd Light ventricular short-axis diameter at end diastole Refer to "Distance
Measurement
(Distance)"
LVPWd Left ventricular posterior wall thickness at end diastole Refer to "Distance
Measurement
(Distance)".
RVIDs Right ventricular short-axis diameter at end diastole Refer to "Distance
Measurement
(Distance)".
IVSTs lnterventricular septal thickness at end diastole Refer to "Distance
Measurement
(Distance)"
LVIDs Light ventricular short-axis diameter at end diastole Refer to "Distance
Measurement
(Distance)".
LVPWs Left ventricular posterior wall thickness at end diastole Refer to "Distance
Measurement
(Distance)".
<<Item to be calculated>>
Calc. item
name
Description [Unit] Calc. formula
[mL]
EDV= LVIDd* LVIDd* LVIDd
ESV End-systolic left ventricular volume ESV= LVIDs* LVIDs* LVIDs
88
[mL]
CO Cardiac output [L/min] CO=SV * HR /1000
EF Ejection fraction [no unit] EF=SV/EDV
FS Fractional shortening FS = (LVIDd -LVIDs)/LVIDd
8. AO/LV
Meas. item
name
Root of aorta Root of aorta diameter Refer to "Distance
Measurement
(Distance)".
LVIDd Light ventricular short-axis diameter at end diastole Refer to "Distance
Measurement
(Distance)".
Calc. item
name
AO/LV AO/LVIDd AO/LVIDd
9. LVOT
Meas. item
name
LA Diam left ventricular outflow tract diameter Refer to "Distance
Measurement
(Distance)"
Calc. item
name
Area left ventricular outflow tract area
Refer to "area"
10. MV
Meas. item
name
MV Diam Mitral valve diameter Refer to "Distance
89
Measurement
(Distance)"
MVArea Mitral valve area Refer to "area
Measurement
11. AV
Meas. item
name
AV Diam Tricuspid valve diameter Refer to "Distance
Measurement
(Distance)"
AVArea Tricuspid valve area Refer to "area
Measurement
5.3.1.3. Urology Measurement in B mode
Meas. item
name
mark unit Meas. method
Residual urine
RUV length
RUV width
RUV height
RUV
cm
cm
cm
ml
Refer to "Distance Measurement (Distance)".
RUV= (/6) * RUV Length* RUV Width* RUV
Height
PV
PV Length
PV Width
cm
cm
Refer to "Distance Measurement (Distance)"
90
PV Height
PV
PPSA
PSAD
cm
ml
ml
ng/ ml
2
PV = (/6) * PV Length* PV Width* PV Height
PPSA0.12PV
PSAD SPSA[ng]/PV[ml]
NoteSPSA must be input by manual in patient
interface when you select the urology exam type
Left_Kidney
Length
Width
Height
VOL
cm
cm
cm
ml
Refer to "Distance Measurement (Distance)
V = (/6) * Length* Width* Height
Right_Kidney
Length
Width
Height
VOL
cm
cm
cm
ml
V = (/6) * length* Width* Height
T-Zone
Length
Width
Height
VOL
cm
cm
cm
ml
Bladder Vol
Length
Width
Height
VOL
cm
cm
cm
ml
StA%
A Out
A In
StA%
cm
2
cm
2
%
Refer to "Area Measurement (Area)
StD%
D Out
D In
StD%
cm
2
cm
2
%
Vessel Area
Vessel
Area
cm
2
Vessel Dis
Vessel Dis
cm Refer to "Distance Measurement (Distance)
91
5.3.1.4 Pediatric Measurement in B mode
Hip
Hip is used for evaluating the abnormity of the cotyle. In order to make measurement, user has to draw
three lines on the image responding to the anatomy. The system will calculate the angles automatically.
Operation Method:
Select HIP from Pediatric submenu on CALC menu. Press Enter key to select it.
The first line D1 will be displayed on the screen and use the Trackball to move the line.
The second line D2 will be displayed on the screen, repeat the above procedure to fix the second
line and third line D3. The angles between these three lines will be displayed on the screen.
Note: is the angle between the D1 and D2(acute angle). is the angle between D1 and D3(acute angle)
5.3.1.5 Small Parts Measurement in B mode
Small Parts Measurement is the same as the normal Measurement.
92
5.3.1.6 Vascular Measurement in B mode
Meas. item
name
mark unit Meas. Method and calc. formular
Prox CCA
Rt/Lt
A Out
A In
StA%
D Out
D In
StD%
Vessel Area
Vessel Dis
cm
2
cm
2
%
cm
cm
%
cm
2
cm
Refer to Area/Circumference Measurement
(Area)
Refer to Area/Circumference Measurement
(Area)
StA%= (A Out- A In/ A Out *100%
StD%= (D Out- D In/ D Out *100%
Refer to Area(Ellipse)
Mid CCA
Rt/Lt
The same as above The same as above The same as above
Distal CCA
Rt/Lt
93
Prox ICA
Rt/Lt
Mid ICA
Rt/Lt
Distal ICA
Rt/Lt
ECARt/
Lt
Vertebral A
Rt/Lt
INT IILRt
/Lt
EXT ILRt
/Lt
ILIACRt /
Lt
CFA Rt /
Lt
ProFunRt/
Lt
LTCIRRt/
Lt
SFA Rt /
Lt
Pop A Rt/
Lt
94
ATARt/
Lt
PTARt/
Lt
PERONRt
/Lt
DRPEDRt
/Lt
5.3.1.7 GYN Measurement in B mode
Meas. item name Mark Unit Meas. Method and calc. formular
UT UT_L
UT_W
UT_H
UT_D
CX_L
cm
cm
cm
cm
cm
UT_D= UT_L +UT_H + UT_W
Cervix Vol. Length
Height
Width
Volume
cm
cm
cm
cm
PV = (/6) * L* W* H
ENDO endometrium cm Refer to "Distance Measurement (Distance)
Left_OV_Volume Left_OV_L
Left_OV_W
Left_OV_H
Left_OV_Volume
cm
cm
cm
ml
Left_OV_Volume = (/6) * L* W* H
95
Right_OV_Volume Right_OV_L
Right_OV_W
Right_OV_H
Right_OV_Volume
cm
cm
cm
ml
PV = (/6) * L* W* H
Left_FO_D Length
Width
cm
cm
RightFO_D Length
Width
cm
cm
Uterine Artery A Out
A In
STA%
D Out
D In
STD%
Vessel Area
Vessel Dis
cm
2
cm
2
%
cm
cm
%
cm
2
cm
Refer to Refer to Area(Ellipse)
StA%= (A Out- A In/ A Out *100%
StD%= (D Out- D In/ D Out *100%
96
5.3.1.8 OB Measurement in B mode
GS GS
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
EDD = current date + (280days average
UGA)
CRL CRL
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
EDD = current date + (280days average
UGA)
YS YS cm Refer to "Distance Measurement
(Distance)
BPD BPD cm Refer to "Distance Measurement
97
GA
EDD
EFW
week/day
mm/dd/yyyy
(Distance)
OFD OFD
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
HCellipse HC
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
APD APD
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
TAD TAD
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
ACellipse AC
GA
EDD
EFW
cm
week/day
mm/dd/yyyy
g
(Distance)
FTA FTA
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
FL FL
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
SL SL cm Refer to "Distance Measurement
(Distance)
APTD APTD
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
TTD TTD
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
ThC ThC cm Refer to "Distance Measurement
(Distance)
Humerus Humerus
GA
cm
week/day
(Distance)
98
EDD mm/dd/yyyy
ULNA ULNA
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
Tibian Tibian
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
RAD RAD cm Refer to "Distance Measurement
(Distance)
FIB FIB cm Refer to "Distance Measurement
(Distance)
CLAV CLAV
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
CER CER
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
CM CM cm Refer to "Distance Measurement
(Distance)
NF NF cm Refer to "Distance Measurement
(Distance)
OOD OOD
GA
EDD
cm
week/day
mm/dd/yyyy
(Distance)
IOD IOD cm Refer to "Distance Measurement
(Distance)
NB NB cm Refer to "Distance Measurement
(Distance)
Lvent Lvent
GA
EDD
cm Refer to "Distance Measurement
(Distance)
HW HW cm Refer to "Distance Measurement
(Distance)
LtKid LtKid cm Refer to "Distance Measurement
(Distance)
RtKid RtKid cm Refer to "Distance Measurement
(Distance)
99
LtRenalAP LtRenalAP cm Refer to "Distance Measurement
(Distance)
RtRenalAP RtRenalAP cm Refer to "Distance Measurement
(Distance)
LVWrHEM LVWrHEM cm Refer to "Distance Measurement
(Distance)
MAD MAD cm Refer to "Distance Measurement
(Distance)
AFI AF1
AF2
AF3
AF4
AFI
cm
cm
cm
cm
cm
(Distance)
(Distance)
(Distance)
(Distance)
AFI=AF1+AF2+AF3+AF4
FBP AF
Result
cm
Scores
(Distance)
Give result according to AF
5.3.1.9 Carotid Measurement in B mode
100
Subclavian ALt/Rt A Out
A In
StA%
D Out
D In
StD%
Vessel Area
Vessel Dis
cm
2
cm
2
%
cm
cm
%
cm
2
cm
Refer to "Area Measurement (Ellipse)
StA %=A Out-A In/ A Out*100%
StD %=D Out-D In/ D Out*100%
Prox CCALt/Rt The same as
above
The same
as above
The same as above
Mid CCALt/Rt The same as
above
The same
as above
The same as above
Distal CCALt/Rt The same as
above
The same
as above
The same as above
BulbLt/Rt The same as
above
The same
as above
The same as above
Prox ICALt/Rt The same as
above
The same
as above
The same as above
Mid ICALt/Rt The same as
above
The same
as above
The same as above
Distal ICALt/Rt The same as
above
The same
as above
The same as above
ECALt/Rt The same as
above
The same
as above
The same as above
VertebralLt/Rt The same as
above
The same
as above
The same as above
General Measurement The same as
above
The same
as above
The same as above
Flow Volume Vessel Dis
Vessel Area
cm
cm
2
101
5.3.1.10 Abdomen Measurement in B mode
CBD CBD cm Refer to "Distance Measurement (Distance)
GB Wall GB Wall cm Refer to "Distance Measurement (Distance)
Liver Length Liver
Length
cm Refer to "Distance Measurement (Distance)
Prox Aorta Height
Width
A Out
A In
StA%
D Out
D In
StD%
Vessel Area
Vessel Dis
cm
cm
cm
2
cm
2
%
cm
cm
%
cm
2
cm
Refer to "Area Measurement (Trace)
StA%=A Out-A In/ A Out*100%
StD %=D Out-D In/ D Out*100%
Mid Aorta 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
Spleen Length
Height
Width
cm
cm
cm
102
Volume ml Volume = (/6) * Length* Width* Height
Renal Vol.(Rt/Lt) Length
Height
Width
cm
cm
cm
Lliac(Rt/Lt) Height
Width
A Out
A In
StA%
D Out
D In
StD%
Vessel Area
Vessel Dis
cm
cm
cm
2
cm
2
%
cm
cm
%
cm
2
cm
StA%=A Out-A In/ A Out*100%
StD%=D Out-D In/ D Out*100%
5.3.2 Measurement in M mode
5.3.2.1 General Measurement in M mode
1. M distance
This feature allows the measurement of the distance between two points. It is a measurement between the two
horizontal lines that lean on the two cursors. The position of the vertical time line does not affect the distance
measurement
Operation:
Rotate the trackball to select the M distance item in the menu. A start cursor+ will appear on the screen. Move
the cursor through rotating the trackball and press Enter-key to fix the first point. The second cursor will appear.
Move the second cursor to the end point and press Enter-key to fix it. The measurement result will appear on the
right side of the screen.
2. M time
103
Time is the measurement between the two vertical time lines created by two cursors. The position of the horizontal
distance line does not affect time measurements.
3. Velocity
Velocity is the measurement between the intersections of the two cursors. Velocity can be positive or negative, and
is measured as the rate of change between the two points defined by the intersections of the cursors in cm/sec.
4. HR
HR is the measurement between the two vertical lines that are created by two cursors in beat per minute (BPM).
The position of the horizontal distance line does not affect HR.
5.3.2.2 Cardiology Measurement in M mode
1. Distance
Refer to distance measurement in general measurement in M mode
2. HR
Refer to HR measurement in general measurement in M mode
3. Ejection_Time
Refer to Time measurement in general measurement in M mode
4. LV
104
5. LVSHORT
Meas. item name Description [Unit] Meas. Method
IVSd lnterventricular septal thickness at
end diastole [mm]
Refer to distance measurement
(Distance)in B mode
diameter at end diastole [mm]
Refer to distance
measurement(distance) in B mode
diameter at end systole [mm]
(Distance) in B mode
thickness at end diastole [mm]
(Distance) in B mode
EDV End-diastolic left ventricular
volume [mL]
EDV = 7.0 / (2.4 + LVIDd) *
LVIDd * LVIDd * LVIDd
ESV End-systolic left ventricular
volume [mL]
ESV = 7.0 / (2.4 + LVIDs) *
LVIDs * LVIDs * LVIDs
SV Stroke volume [mL] EDV - ESV
CO Cardiac output [L/min] SV x HR /1000
CI Cardiac index CO/BSA
EF Ejection fraction [no unit] SV / EDV
FS Fractional shortening [no unit] (LVIDd -LVIDs)/LVIDd
AIVSD Anterior wall of interventricular
septum at end diastole
Refer to distance measurement in
M mode
PIVSD Posterior interventricular septum
distance at end diastole
M mode
ENDOD Endocardium of posterior wall of
left ventricular at diastole
M mode
EPID Epicardium at diastole Refer to distance measurement in
M mode
AIVSS Anterior wall of interventricular
septum at end systole
M mode
PIVSS Posterior wall of interventricular Refer to distance measurement in
105
6. AV
septum at end systole M mode
ENDOS Endocardium of posterior wall of
left ventricular at systole
M mode
EPIS Epicardium at systole Refer to distance measurement in
M mode
IVSd interventricular septum at end
diastole[mm]
diameter at end diastole [mm]
diameter at end systole [mm]
thickness at end diastole [mm]
EDV End-diastolic left ventricular
volume [mL]
EDV = 7.0 / (2.4 + LVIDd) *
LVIDd * LVIDd * LVIDd
ESV End-systolic left ventricular
volume [mL]
ESV = 7.0 / (2.4 + LVIDs) *
LVIDs * LVIDs * LVIDs
SV Stroke volume [mL] EDV - ESV
CO Cardiac output [L/min] SV x HR /1000
CI Cardiac index CO/BSA
EF Ejection fraction [no unit] SV / EDV
FS Fractional shortening [no unit] (LVIDd -LVIDs)/LVIDd
AOD Aorta diameter at diastole[mm] Refer to distance measurement in
M mode
LAS Posterior interventricular septum
distance at end diastole[mm]
M mode
AVO AVO[mm] Refer to distance measurement in
M mode
LVET Left ventricular ejection time[s] Refer to time measurement in M
106
7. AVSHORT
mode
PEP Pre-ejection period[s] Refer to time measurement in M
mode
LAR Ratio between LA and aorta LAR=LAS/AOD
ETR Ratio between PEP and LVET ETR=PEP/LVET
AAW Posterior wall of aorta at diastole Refer to distance measurement in
M mode
PAWD Posterior wall of aorta at diastole Refer to distance measurement in
M mode
AAL Anterior leaflet at AVO Refer to distance measurement in
M mode
PAL Posterior leaflet at AVO Refer to distance measurement in
M mode
PAWS Posterior wall of aorta at leaflet
closed point
M mode
PLA Posterior wall of posterior leaflet
of aorta of at closed point
M mode
AO Ratio between LA and aorta[mm]
LAS Ratio between PEP and LVET
AVO AVO[mm]
LVET Left ventricular ejection time[s]
PEP Pre-ejection period[s]
LAR Ratio between LA and aorta LAR=LAS/AOD
107
8. MV
9. MV Expert
10. AV (EXPERT)
ETR Ratio between PEP and LVET ETR=PEP/LVET
Meas. item name Description [Unit]
D D wave
E E wave
F F wave
EPSS The distance between mitral valve and interventricular septum
Calc. item name Description [Unit]
EPSS Distance between the mitral valve and interventricular septum[cm]
DEex D-E shift of mitral valve[s]
DEsl D-E slope of mitral valve[deg]
EFsl E-F slope of mitral valve[deg]
EFSLP Closed velocity of mitral valve[cm/s]
EPSS The distance between E point and interventricular septum[mm]
CEAMP The amplitude of E wave[mm]
CAAMP The amplitude of A wave[mm]
DEAMP The amplitude of DE wave[mm]
DESLP The open velocity of mitral valce[cm/s]
CA/CE The ratio between A wave and E
wave
CAAMP/CEAMP
108
11. AO/LV
12. LVOT
LVOT Diam:According to the left ventricular outflow tract diameter automatically calculated left
ventricular outflow area.
Left ventricular outflow tract diameter measurement method refer to M distance "
13. TV
R-R interval Select one or two cycles, automatically calculate the R-R interval, the measurement method
refer to M Time "
14. PulV
R-R interval Select one or two cycles, automatically calculate the R-R interval, the measurement method
AOD Aorta diameter[mm] M distance
LAD Left ventricular diameter[mm] M distance
AVD Diameter of mitral valve[mm] M distance
ET Ejection time[ms] M Time
RVOTD Diameter of right ventricular
outlet[mm]
M distance
AO Root Aorta diameter[mm] M distance
LA Diam Left ventricular diameter[mm] M distance
LVOT Diam Diameter of mitral valve[mm] M distance
LA/AO Ratio between left artrium and
aorta
LAD/AOD
109
refer to M Time "
5.3.3 Measurement in PW mode
5.3.3.1 General Measurement in PW mode
1. Velocity
1) Rotate the trackball to move the cursor to the velocity item in the menu and press Enter-key to select
it. Acursor+ will appear on the screen.
2) Move the cursor + to the place where need to be measured and press Enter-key to fix it.
3) The value of velocity and pressure will appear on the screen.
4) Repeat step 1) to 3) to measure the next point.
2. Distance
The measurement method is the same as distance in general measurement in B mode.
3. Peak
Calculate the velocity over one cardiac cycle. The velocity, slope, RI and SD ratio are calculated.
1) Scan the object area in PW mode and freeze the image
2) Rotate the trackball to move the cursor to the Peak item in the menu and press Enter-key to select.
3) A cursor+ will appear on the screen. Move the cursor + to the peak point where the cardiac systole
and press Enter-key to fix it.
4) A second cursor+ will appear on the screen again. Fix the second cursor to the end point where the
cardiac diastole
5) When the two points are all fixed, the value of Vs,Vd,RI,SD(Vs/Vd) will appear on the right side of
the screen.
110
4. Full Trace
1) Rotate the trackball to move the cursor to the auto trace item in the menu.
2) Press Enter-key to select it. Acursor| will appear on the screen.
3) Move the cursor by rotating the trackball to the start point of the one cycle and press Enter-key to fix it.
Asecond cursor | will appear.
4) Rotate the trackball the end point of the cycle and press Enter-key to fix it.
5) After the measurement, the value of Vs,Vd,RI,SD ratio,PI will appear on the screen.
Peak Velocity or Doppler frequency
Peak velocity over one cardiac cycle (Vpk)
Doppler Time Distance
Time distance between two cursors in ms. The invert is the heart beat rate if the two cursors are at one
cardiac cycle period. (T)
Spectral Velocity Time Integral (VTI)
VTI= Vpk *(delta t). Where delta t is T/N, N is the data point over one cardiac cycle.
Pulsatility Index (PI)
It can be used to represent the degree of pulse-wave damping at different arterial sites; the smaller the PI, the
greater the degree of damping. Typical value for CCA is 1.90+/-0.5.
PI = | (A-B)/TimeAvgPk |, TimeAvgPk= Vpk/ N
Resistive Index (RI)
Vary from 0 to 1. It is an indicator of the circulatory resistance. Typical value for CCA is 0.75+/- 0.05.
RI = | (A-B) /A|
Note:
a) In order to get accurate result, the PW image must be clear and high quality.
b) Insure you fix the cursor at the exact place of cardiac systole and diastole
Manual editing of the envelope curve:
1:After you get the envelope curve press Update, the start point will be displayed in orange.
2:Move trackball to the start point, where you want to edit, press Enter key to enter into manual status.
3:Trace the curve by trackball, and press Enter key to finish.
111
4:The envelope will be updated after being edited.
5:Select the cycle, the result the result will be displayed on the screen.
5. Manual trace
Automatically measure the Peak Systolic Velocity, VTI, end diastolic velocity, HR, Time, minimum velocity, PI,
and RI after manually tracing of the curve is finished.
Note: Manual trace requires the user to trace two peak point of two cycles
6. STD
Measure the diameter reduction ratio of vessel in B mode
1) Move the cursor to the STD item and press Enter-key to select it .Acursor + will appear on the screen.
2) Move the cursor to the point of outside wall of the vessel and press Enter key to fix it. The method to
measure the diameter of the outside wall of the vessel is the same as distance in genera measurement in B
mode
3) When the diameter of outside wall of the vessel is finished,the cursor +will appear on the screen again.
Measure the diameter of the stenosis area;
4) The value of every diameter and STD will be displayed in the result window.
7. STA
Measure the area reduction ratio of vessel in B mode
1) Move the cursor to the STA item and press Enter-key to select it .Acursor +will appear on the screen.
2) Move the cursor to the point of outside wall of the vessel and press Enter-key to fix it. The method to
measure the area of the outside of the vessel is the same as area-ellipse in genera measurement in B mode
3) When the area of outside of the vessel is finished , the cursor +will appear on the screen again. Measure
the area of the stenosis area;
4) The value of every area and STD will be displayed in the result window.
8. Area
The same as area-trace in general measurement in B mode.
9. ICA/CCA
Measure ICA and CCA separately and get the ratio value of ICA/CCA
10. Flow volume
Diam Diameter of vessel [mm] Refer to distance measurement
VTI Velocity time integral Refer to area-trace measurement
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11. Heart rate
The measurement is the same as heart rate in general measurement in M mode
5.3.3.2 Cardiology Measurement in PW mode
1. MV
Measurement of Mitral valve function is performed in frozen Doppler spectral trace.
<<Measurement and calculation items>>
Meas. item name Description [Unit] Meas. procedure / Calc. formula
E Vel E-wave flow velocity [cm/s] Refer to "Velocity Measurement'.
A Vel A-wave flow velocity [cm/s] Refer to "Velocity Measurement'.
PHT Pressure half time [ms] Refer to " Velocity Measurement".
E Dur E-wave duration [ms] Refer to "Time Measurement (Time)".
A Dur A-wave duration [ms] Refer to "Time Measurement (Time)".
IRT Isovelocity relaxation time [ms] Refer to Time Measurement (Time)".
MV VTI Mitral valve VTI [m] Refer to Full trace.
MV VM Mitral valve mean velocity
[cm/s]
Refer to Full trace
MV VP Mitral valve maximum velocity
[cm/s]
Refer to Full trace
MV MPG Mitral valve mean pressure
gradient [mmHg]
Refer to Full trace
MV PPG Mitral valve maximum pressure
gradient [mmHg]
Refer to Full trace
MV Diam Mitral valve diameter [mm] Refer to Distance Measurement in B mode
HR Heart rate [bpm] Refer to "Heart Rate Measurement (HR)"
Time Time Refer to time measurement in M
mode
SV Stroke volume[ml] SV= 0.785 * diameter *
diameter *VTI
CO Cardiac output[L/min] CO=SV*heart rate/1000
HR Heart rate Heart rate=60/time
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E/A [no unit] E Vel / A Vel
A/E [no unit] A Vel / E Vel
SV Stroke volume [mL] 0.785 x (MVDiam)
2
* abs|VTI |
CO Cardiac output [L/min] SV x HR / 1000
MV Area Mitral valve area [mm
2
] 220/ PHT
Note:
[MV Diam] can only be performed in 2-D mode.
<<Measurement points>>
1) Measure [E Vel] and [AVel]. Measure [PHT]. Measure [E-Dur], [A-Dur], and [IR] Measure [HR].
2) Measure [MV V Trace].
3) Measure [MV Diameter
2. AV
Measurement of aortic valve function is performed by using 2-D-mode and Doppler images.
<<Measurement items>>
Meas. Item name Description [Unit] Meas. method
LVOT Vel PW-mode LV out tract flow
velocity [cm/s]
Refer to "Velocity Measurement'.
LVOT PG PW-mode LV out tract
pressure gradient [mmHg]
Refer to "Velocity Measurement'.
LVOT V General
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LVOT VTI Aortic valve VTI [m] Refer to Full trace
LVOT VM Aortic valve mean velocity
[cm/s]
Refer to Full trace
LVOT VP Aortic valve maximum
velocity [cm/s]
Refer to Full trace
LVOT MPG Aortic valve mean pressure
gradient [mmHg]
Refer to Full trace
LVOT PPG Aortic valve maximum
pressure gradient[mmHg]
Refer to Full trace
AoV VM
AoV MPG Aortic valve mean pressure
gradient [mmHg]
Refer to Full trace
AoV PPG Aortic valve maximum
Refer to Full trace
LVOT Diam Left ventricular outflow tract
diameter [mm]
Refer to Distance Measurement in B
mode.
HR Heart rate [bpm] Refer to "Heart Rate Measurement
(HR)".
SV Stroke volume [mL] 0.785 x (LVOT Diam)
2
* abs|VTI |
AV Area AoV area [cm
2
] SV/AoV VTI / 100
Note:
[LVOT Diam] can only be performed in 2D mode
1) Measure [LVOT Vel]. Measure [HR].
.
2) Measure [LVOT Diam]
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3. TV
Measurement of tricuspid valve function is performed by using Doppler images.
<<Measurement items>>
Meas. Item name Contents Meas. Method
TV VTI Tricuspid valve VTI [m] Refer to "Manual Trace Measurement "..
TV VM Tricuspid valve mean velocity [cm/s] Refer to " Manual Trace Measurement "..
TV VP
Tricuspid valve maximum velocity
[cm/s]
Refer to " Manual Trace Measurement ".
TV MPG
Tricuspid valve mean pressure gradient
[mmHg]
Refer to " Manual Trace Measurement ".
TV PPG
Tricuspid valve maximum pressure
gradient [mmHg]
Refer to "Manual Trace Measurement ".
TV Vel Tricuspid valve velocity [cm/s] Refer to "Velocity Measurement.
TV PG
Tricuspid valve pressure gradient
[mmHg]
Refer to " Velocity Measurement'.
1)Measure [TV VEL Trace]
2)Measure [TV VEL]
4. PV
Measurement of pulmonary valve function is performed by using a Doppler image.
<<Measurement items>
PV VTI Pulmonary valve VTI [m] Refer to "Full Trace Measurement ".
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PV VM Pulmonary valve mean
velocity [cm/s]
Refer to "Full Trace Measurement ".
PV VP Pulmonary valve maximum
velocity [cm/s]
PV MPG Pulmonary valve mean
PV PPG Pulmonary valve maximum
Refer to Velocity Measurement
PV Max Vel Maximum velocity [cm/s] Refer to " Velocity Measurement
PV Max PG Maximum pressure gradient
[mmHg]
Refer to "Velocity Measurement
PV Diam Pulmonary artery diameter
[mm]
Refer to "Distance Measurement in B
mode.
HR Heart rate [bpm] Refer to "Heart Rate Measurement
(HR)
RV ET Ejection time [ms] Refer to "Time Measurement (Time)
RV AcT Acceleration time [ms] Refer to "Time Measurement (Time)
RV PEP Pre-ejection period [ms] Refer to "Time Measurement (Time)
Note:
[PV Diam] can only be performed in 2D mode
<<Calculation items>>
1) Measure [PV Vel]
SV Stroke volume [mL] 0.785 x (PV Diam)
2
* abs|VTI|
RV AcT/ET Ratio of AcT to ET RV ACT / RV ET
RV STI Systolic time interval RV REP / RV ET
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2) Measure [PVV Trace]
3) Measure [ET],[ACT], and [PEP]
4) Measure [PV Diam]
5.3.3.3 Urology Measurement in PW mode
The measurement method and calculation items are the same as general measurement in PW mode
5.3.3.4 Pediatric Measurement in PW mode
The measurement method and calculation items are the same as general measurement in PW mode.
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5.3.3.5 Small parts Measurement in PW mode
The measurement method and calculation items are the same as general measurement in PW mode.
5.3.3.6 Vascular Measurement in PW mode
The measurement method and calculation items are the same as manual trace
5.3.3.7 GYN Measurement in PW mode
The measurement method and calculation items are the same as manual trace
5.3.3.8 OB Measurement in PW mode
The measurement method and calculation items are the same as GYN measurement in PW mode.
5.4 Edit measurement results
After the user finishes the measurements, this system allows users to move the position of measurement results,
or change the font size of measurement results.
To move result position, operations are as follows:
In the measurement status, rotate SK2-key to choose Move result position.
Press SK2-key, and use trackball to move the position of measurement results .
Press Enter-key to confirm it
To reset result position, operations are as follows:
In the measurement status, rotate SK3-key to choose Reset result position
Press SK3-keythe position of current measurement result will be reset back to default.
To change the font size of measurement results, operations are as follows:
In the measurement status, rotate SK1-key to adjust the font size of measurement results.
To reset the font size of measurement results, operations are as follows:
In the measurement status, press SK1-key, the font size of measurement results will be reset back to default.
The system default font size is 11.
5.5 Report
After finishing the exam, press the Report-key to pop up report interface, edit and print the report.
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Report Interface
Choose the imageClick the image can add the image to the image area in the report, and click the image in the
report to remove it.
Preview: preview the whole report and its format before printing
Print: print the current report, please make sure that the printer is nomal working.
Save: store the report on the disk.
OK: confirm the operation and exit the interface
Undo: cancel the operation and exit the interface
Edit Meas: Press this icon to enter into Measurement Edit Item. Choose the measurement result, which you want
to display in the report. Customer also can edit the result.
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Graph : Under OB report you can press this icon to enter in to see the fetal production graph.
Input Template: Input annotation from templates
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Chapter 6 Preset
6.1. Recall Preset
a) Press button to choose the probe type.
b) Choose a clinical application.
c) Choose a preset.
d) Choose a user defined preset and double-click it.
The default choice of the system is DEFAULT preset.
After entering into the system, if you want to change preset and do not want to quit the current interface, operate
as follows:
1 Press MENU- knob.
2 Rotate MENU- knob and select [Utility] item.
3 Press MENU-knob to enter into the item.
4 Now SK1SK5 Shortcut keys are corresponding with following operation:
SK1rotate SK1 to choose the clinical application.
SK2rotate SK2 to choose the preset.
SK3rotate SK3 to choose the user-defined.
SK3press SK3 edit user name (just user 1 to user 5 can be edited ).
SK4press SK4 to load preset.
SK5press SK5 to save preset. (Just can save into user 1 to user 5 can be edited )
6.2. Save user defined preset
1) Choose and recall a preset first.
2) Adjust parameters to current preset.
3) Press MENU- knob when adjustment is finished. Rotate MENU- knob and select [utility] item. Press MENU-
knob to enter.
4) Rotate SK1 to choose clinical application name (skip this step if do not need adjustment).
5) Rotate SK2 to choose the name of preset(skip this step if do not need adjustment)
6) Rotate SK3 to choose user defined. Press SK3 for editing user name. (Just user 1 to user 5 can be edited).
7) Press SK5 to save preset.
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6.3 Manage Preset
Press key to enter into system setting interface. Select preset page. Add or delete the current preset.
Name: input Application/Preset/User Defined name.
Exam Type: select clinical application.
Add: add Application/Preset.
Delete: delete a Application/Preset .
Modify: revise Application/Preset/User Defined name
Restore Preset: restore the preset to factory setting.
Import: import preset to system. Plug in U disk which has preset. Press Import key ,preset can be imported into
the system .
Export: export system preset. Plug in USB, Press the Export key ,System automatically derive the preset to U
disk.
Cancel: exit system setting interface
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Chapter 7 System Setting
Press the key to enter system setting interface. User can do user-defined setting.
7.1. General settings
Normal Settings: set the hospital information, date-time, language etc.
Hospital
Information
hospitalDepartment Input hospital name, department name
Date-Time
Set Date Time
Set Regional
Set Date and time (need password)
Set Time Zone, Data Format, Time Format
Language
ChineseEnglish;
French; Spanish;
Russian; Polish;
Portuguese
Switch language interface
Image Option
Always show TGC
Curve or not
Select it ,it will always show TGC Curve .
Fast storage 3 seconds/5 seconds/10 Please refer 4.4.6
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seconds fast storage
User-defined setting the
storage seconds
Fast storage manually
Storage derive to mobile
medium
Color Map Click the Configure key to set the color map
Keyboard Settings,
Footswitch Video PrintPC Print
Freeze/UnFreezeCine
SaveStill Save
Choose the footswitch function
Print-key Video printing
PC print
Set the print-key function
Trackball
Option
Sensitivity(1~20) Set the sensitivity of the trackball option.
PC print
selection
Picture and info or Only
Picture
Paper Size
Please refer to 3.6.3
Video
Print Option
Image Only(640*480)
Standard(800*600)
Please refer to 3.6.1
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7.2 Measurement
Set the measurement formula of measurement.
Edit Settings: Click the measurement page, and click on the Edit page, then users can edit custom
configuration measurement.
1Package Name: Choose the different examinations.
2Choose the different exam modes.
3Choose the measurement item and click "UP" or "Down" button to move it`s position
4Add Folder: Click this button to add a new item.
5Clicking Add Meas. can add a new measurement.
General Settings: Click the General page, and you can do some general settings of measurement items
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Font size: Set to default font size of the measurement results
HR cycle options:
One cycle: one cycle to measure heart rate in the Doppler envelope calculation
Two cycles: two cycles to measure heart rate in the Doppler envelope calculated, the result will be more accurate.
Unit: You can set the unit of measurement results
OB Table Setting: Click OB Table page, you can set the formula of the OB measurement items for measuring
fetal weight formula.
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Set measurement Item: choose a measurement project, gestational age table or developmental table, and then
choose a formula, click the information button, you can view the current formula. Click New, you can create
a new formula in the current directory.
Fetal Weight: Select the EFW equation, or EFW development table, and then choose a formula, click on the
information button, you can view the information of current fetal weight formula. Click New, you can create
a new fetal weight formula in the current directory.
7.3 Comment:
Set the comment function, manage the comment Library
Options Page
Search option Search comment or
Abbreviations
Input search function
Select the comment item, it will search notes
when searching
Select abbreviations, it will search
abbreviations when searching
Font size Font family Set the font family of notes
Font size Set the font size of notes
Library Page: Edit and delete the annotation in the comment library.
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Edit notes:
1. Select exam type, select annotation that needs to be edited
2. Input the comments in the lower right corner of the comment box. Input the abbreviations in the abbreviation box.
3. Press the edit-key, finish the edition of current comment.
Add notes:
1. Select the exam mode which the added notes belong to.
2. Input the comments in the lower right corner of the comment box. Input the abbreviations in the abbreviation box.
3. Press the SET-key, current comment will be added to the comment library.
Delete notes:
1. Select the exam mode, and select the notes that need to be deleted
2. Press delete-key to delete current comment.
Exit: exit current page
7.4 Report
Including the report design and report template
Customize settings: set the design of the report
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Report Nameselect report type
LeftSet left margins
RightSet right margins
TopSet top margins
BottomSet bottom margins
Sections: list all the sections which can be added
Selected sections: Section used in current report
All: Click this button to add " available section " to " selected section
Add: Select the section that need to be added, then click this button, add selected section "selected section"
Delete: Select the section that need to be deleted, then click this button, delete the selected section from the
"selected section"
Delete all: Click this button to empty the content of "selected section"
Section attribute: Set the display of section, you can select arrange horizontally or vertically
Set rows and columns of the arrangement.
Select the "Ultrasound image", set the width and height of the image
Save: After setting the current report, click the button, save the settings
ExitExit the page
Template Page:
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Modify template note: Select the template note which you want to change, input modification content in the right box
Add Folder: Press this icon to add a new Folder and name it.
Add Item: Press this icon to a new Item under current folder, and name it.
Delete: Press this icon to delete the template, which you selected.
Save: Save the changes.
General Page:
Logo Setting: Upload Logo and set logo size.
Image Layout: Choose different styles of image layout.
Save: Save the changes.
Note: the LOGO should be named with hLogo in PNG format, which resolution is 168x169. And put LOGO file into
the folder named hLogo.
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7.5 Network
Press key to enter into the system setting unit. Click the page of Network Settings to enter into the network
settings interface.
Before setting up the network settings, plug the cable into the LAN port of the system.
Network Settings
Network Adapte: Display the existing network cards on this system. The user can select the network card for current
use.
Obtain an IP address automatically: When this option is selected, the system will obtain an IP address automatically
Use the following IP address (recommended): Set the IP address of the system manually. After setting, click Apply to
confirm the application.
IP address: Input the IP address of the system manually, and make sure the IP address of the network printer is in the
same network segment.
Subnet Mask: Input the subnet mask manually.
Default Gateway: Input the gateway manually.
DNS server: Input DNS server manually.
Network Connection Status: Check the network connection status.
Connected: The system is connected to the network successfully.
Unconnected: The system is not connected to the network.
Network Information: Display the current network information
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Configuration information: Click this button to display the network configuration information
For more information: Click this button to display network details
Release of the connection: Click this button to disconnect the current connection
Update Connection: Click this button to update the current connection status
Network test: in the case of network connection status is connected, enter the IP address of the test, click the test, you
can test the network the connection status between the IP of current system and the IP that needs to be tested.
Network Storage: With this feature, you can save the image to PC by network.
To use the network storage function, the user should connect the target computer to the network first, and build a new
folder on the computer, right-click it to open the attribute, select shared page, set to share this folder on the network and
allow network users to change the file (as shown below).
Note: the folder built on the computer is not allowed to sit on the desktop, otherwise create an error 67.
Click Advanced Sharing
133
Select Share this folder, and click Permissions to modify user permissions.
Select Full Control, Change, Read for Allow, click OK to complete modification.
134
Click Network Storage page, enter the network storage settings page. Then input shared directory name and IP address,
and click Add.
Shared Dir: The shared directory name should be same as the shared folder name in target computer.
IP address: the IP address of the computer with the shared directory
User name: input the name of computer account
Password: input the password of computer account
Add: add a network storage service
Delete: can delete the selected network storage service
Note: you can add multi-numbers of network storage service to realize the transmission among multi systems.
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7.6 System
Display the settings of system configuration information and functions
System information:
System SN: display the unit SN
Build time: The build time of software
Version: display the current software version and hardware version
Upgrade: When the U-disk with the upgrading software is inserted to the system, click this button to upgrade
software.
Operating System: Display the operating system used by the current system
Function settings: DICOM, i-Image
TM
, 4D, CFM mode, Pulse Doppler
Display the status of current function, and click the turn on button to turn on this function.
Note
DICOM is option. If need to turn on this function, the user need to input the password. Please contact the
CHISON's authorized service engineer to get the corresponding password.
Software Lease: Key Input
It is time to the data time, Q9 cannot be entered for use. User can decode by pressing Key Input key and input the code
which gets from CHISON's authorized service engineer.
Log: Export Log
Plug in U disk to export log files which saved on system automatically for engineers to analyze.
License: Export License
Plug in U disk to export license to U Disk.
Printer management: Users can manage the printers. Click Open to into the printer management screen.
136
Operating methods: insert U disk with installation driver to the system, click Install Driver,
Select the driver, click Install, the system will jump out installation guide. Complete the installation by following up
the guide.
The steps are as below
137
Click Yes
Select Dynamic Mode, click Install
138
Being installed automatically
Click Finish to finish the printer installation.
AddClick Add, complete adding printer according to operation guide.
139
Click NEXT
Select Local printer attached to this computer, and Click Next.
140
Select Use the following port, and click Next.
Select the printer, and click "Next".
141
Select Keep existing driver (recommended), and Click Next.
Select Yes, and Click "Next".
142
Select Yes to print a test page, and click Next to continue.
Click Finish.
Display Settings: The settings include display device, display Settings, color correction, short Keys etc..
143
Display Devicesset display device
Operating ModeSelect display Mode. There are 3 options:
Single DisplaySingle display
IntelRDual Display CloneIntelRDual Display copy, the display content of two screens are the same.
Extended DesktopExpanded display
Display SelectionSelect display device.
Display Settings Settings of display.
Color Quality: 32Bit can be chosen.
Screen Resolution Resolution of the Screen, it should be 1024*768.
144
Refresh RateRefresh Rate of screen, it should be 60Hertz.
RotationRotation of the screen
Color CorrectionIn this interface, users can correct the color. Adjust the color of monitor.
Hot Keys: The setting of hot keys. In this interface, users can set the shortcut key.
CAUTION:
Please follow the instructions above strictly when changing the display setting or installing the printer
driver. Any other changes are not allowed. If user changes to wrong settings, it may cause the system
abnormal or malfunction. Any doubt or question, please contact CHISON's authorized service
engineer.
145
Chapter 8 Probes
8.1. General Description
Fig.8-1: Convex Probe Overview
The probes provide high spatial and contrast ultrasound imaging of frequencies from 2.5MHz to 12.0MHz. These
probes operate by pulsing sound waves into the body and listening to the returning echoes to produce high-
resolution brightness mode, and a real time display.
8.2. Care and Maintenance
The probes that come with the system are designed to be durable and dependable. These precision instruments
should be inspected daily and handled with care. Please observe the following precautions:
Do not drop the transducer on hard surface. This can damage the transducer elements and compromise the
electrical safety of the transducer.
Avoid kinking or pinching the transducer cable.
Use only approved ultrasonic coupling gels.
8.2.1 Inspecting Probes
Before and after each use, inspect carefully the probes lens, cable, casing, and connector. Look for any damage
that would allow liquid to enter the probe. If any damage is suspected, do not use the probe until it has been
inspected and repaired/replaced by a CHISON's authorized service engineer.
NOTE:
Cable
Stress Relief
Transducer
Scan head (Lens)
Binding line
Handle
146
Keep a log of all probe maintenance, along with a picture of any probe malfunction.
WARNING:
The probes are designed to be used only with this ultrasound system. Use of these probes on any
other system or a non-qualified probe may cause electric shock or damage on the
system/transducer.
8.2.2 Cleaning and Disinfecting
CAUTION:
These transducers are not designed to withstand heat sterilization methods. Exposure to
temperatures in excess of 60 C will cause permanent damage. The transducers are not designed
to be totally submerged in fluid, as permanent damage will result if the entire transducer is
submerged.
Probe Safety
Handling precautions
Ultrasound probes are highly sensitive medical instruments that can easily be damaged by improper handling. Use
care when handling and protect from damage when not in use. DO NOT use a damaged or defective probe.
Failure to follow these precautions can result in serious injury and equipment damage.
Electric shock hazard:
The probe is driven with electrical energy that can injure the patient or user if live internal parts are contacted by
conductive solution:
DO NOT immerse the probe into any liquid beyond the level indicated by the immersion level diagram. Never
immerse the probe connector into any liquid.
Prior to each use, visually inspect the probe lens and case area for cracks, cuts, tears, and other signs of
physical damage. DO NOT use a probe that appears to be damaged until you verify functional and safe
performance. You need to perform a more thorough inspection, including the cable, strain relief, and connector,
each time you clean the probe.
Before inserting the connector into the probe port, inspect the probe connector pins. If a pin is bent, DO NOT
use the probe until it has been inspected and repaired/replaced by a CHISON's authorized service engineer.
Electrical leakage checks should be performed on a routine basis by CHISON's authorized service engineer.
Mechanical hazard:
147
Adefective probe or excess force can cause patient injury or probe damage:
Observe depth markings and do not apply excessive force when inserting or manipulating endocavitary probe.
Inspect probes for sharp edges or rough surfaces that may injure sensitive tissue.
DO NOT apply excessive force to the probe connector when inserting into the probe port. The pin of a probe
connector may bend.
Special handling instructions
Using protective sheaths
The use of market cleared probe sheaths is recommended for clinical applications. Reference FDA March 29, 1991
"Medical Alert on Latex Products".
Protective sheaths may be required to minimize disease transmission. Probe sheaths are available for use with all
clinical situations where infection is a concern. Use of legally marketed, sterile probe sheaths is strongly
recommended for endo-cavitary procedures.
DO NOT use pre-lubricated condoms as a sheath. In some cases, they can damage the probe. Lubricants in these
condoms may not be compatible with probe construction.
Devices containing latex may cause severe allergic reaction in latex sensitive individuals. Refer to FDAs March
29, 1991 Medical Alert on latex products.
DO NOT use an expired probe sheath. Before using a sheath, verify if it has expired.
Endocavitary Probe Handling Precautions
If the sterilization solution comes out of the endocavitary probe, please follow the cautions below:
Sterilant Exposure to Patient (e.g., Cidex): Contact with a sterilant to the patients skin for mucous membrane
may cause an inflammation. If this happens, refer to instruction manual of the sterilant.
Sterilant Exposure from Probe handle to Patient (e.g. Cidex): DO NOT allow the sterilant to contact the patient.
Only immerse the probe to its specified level. Ensure that no solution has entered the probes handle before
scanning the patient. If sterilant comes into contact with the patient, refer to the sterilants instruction manual.
Sterilant Exposure from Probe connector to Patient (e.g. Cidex): DO NOT allow the sterilant to contact the
patient. Only immerse the probe to its specified level. Ensure that no solution has entered the probes connector
before scanning the patient. If sterilant comes into contact with the patient, refer to the sterilants instruction
manual.
Endocavitary Probe Point of Contact: Refer to the sterilants instruction manual.
Probe handling and infection control:
This information is intended to increase user awareness of the risks of disease transmission associated with using
this equipment and provide guidance in making decisions directly affecting the safety of the patient as well as the
equipment user.
148
Diagnostic ultrasound systems utilize ultrasound energy that must be coupled to the patient by direct physical
contact.
Depending on the type of examination, this contact occurs with a variety of tissues ranging from intact skin in a
routine exam to recirculating blood in a surgical procedure. The level of risk of infection varies greatly with the
type of contact.
One of the most effective ways to prevent transmission between patients is with single use or disposable devices.
However, ultrasound transducers are complex and expensive devices that must be reused between patients. It is
very important, therefore, to minimize the risk of disease transmission by using barriers and through proper
processing between patients.
Risk of Infection
ALWAYS clean and disinfect the probe between patients to the level appropriate for the type of
examination and use FDA-cleared probe sheaths where appropriate.
Adequate cleaning and disinfection are necessary to prevent disease transmission. It is the responsibility of the
equipment user to verify and maintain the effectiveness of the infection control procedures in use. Always use
sterile, legally marketed probe sheaths for intra-cavitary procedures.
Probe Cleaning process:
DO disconnect the probe from the system prior to cleaning/disinfecting the probe. Failure to do so could damage
the system.
Perform Cleaning probe after each use
Disconnect the probe from the ultrasound console and remove all coupling gel from the probe by wiping with a
soft cloth and rinsing with flowing water.
Wash the probe with mild soap in lukewarm water. Scrub the probe as needed using a soft sponge, gauze, or
cloth to remove all visible residue from the probe surface. Prolonged soaking or scrubbing with a soft bristle
brush (such as a toothbrush) may be necessary if material has dried onto the probe surface.
WARNING:
To avoid electric shock, always turn off the system and disconnect the probe before cleaning the
probe.
CAUTION:
Take extra care when handling the lens face of the Ultrasound transducer. The lens face is
especially sensitive and can easily be damaged by rough handling. NEVER use excessive force
149
when cleaning the lens face.
Rinse the probe with enough clean potable water to remove all visible soap residue.
Air dry or dry with a soft cloth.
CAUTION:
To minimize the risk of infection from blood-borne pathogens, you must handle the probe and all
disposables that have contacted blood, other potentially infectious materials, mucous membranes,
and non-intact skin in accordance with infection control procedures. You must wear protective
gloves when handling potentially infectious material. Use a face shield and gown if there is a
risk of splashing or splatter.
Disinfecting the probes:
After each use, please disinfect the probes. Ultrasound probes can be disinfected using liquid chemical
germicides. The level of disinfection is directly related to the duration of contact with the germicide. Increased
contact time produces a higher level of disinfection.
In order for liquid chemical germicides to be effective, all visible residue must be removed during the cleaning
process. Thoroughly clean the probe, as described earlier before attempting disinfection.
You MUST disconnect the probe from the system prior to cleaning/disinfecting the probe. Failure to do so could
damage the system.
DO NOT soak probes in liquid chemical germicide for longer than is stated by the germicide instructions for
use. Extended soaking may cause probe damage and early failure of the enclosure, resulting in possible electric
shock hazard.
Prepare the germicide solution according to the manufacturer's instructions. Be sure to follow all precautions
for storage, use and disposal. The transducer is not designed to be totally submerged in fluid. Permanent
damage will result if the entire transducer is submerged. The immersed part shall not exceed the transducer
binding line.
Place the cleaned and dried probe in contact with the germicide for the time specified by the germicide
manufacturer. High-level disinfection is recommended for surface probes and is required for endocavitary
probes (follow the germicide manufacturer's recommended time).
After removing from the germicide, rinse the probe following the germicide manufacturer's rinsing instructions.
Flush all visible germicide residue from the probe and allow to air dry.
Ultrasound transducers can easily be damaged by improper handling and by contact with certain chemicals.
Failure to follow these precautions can result in serious injury and equipment damage
Do not immerse the probe into any liquid beyond the level specified for that probe. Never immerse the
transducer connector or probe adapters into any liquid.
150
Avoid mechanical shock or impact to the transducer and do not apply excessive bending or pulling force to the
cable.
Transducer damage can result from contact with inappropriate coupling or cleaning agents:
Do not soak or saturate transducers with solutions containing alcohol, bleach, ammonium chloride
compounds or hydrogen peroxide
Avoid contact with solutions or coupling gels containing mineral oil or lanolin
Avoid temperatures above 60C. Under no circumstances should the transducer be subjected to heat
sterilization method. Exposure to temperatures above 60 C will cause permanent damage to the
transducer.
Inspect the probe prior to use for damage or degeneration to the housing, strain relief, lens and seal. Do not
use a damaged or defective probe.
Coupling gels
AQUASONIC Gel made by R. P. Kincheloe Company in USAis recommended.
In order to assure optimal transmission of energy between the patient and probe, a conductive gel must be applied
liberally to the patient where scanning will be performed.
CAUTION:
Please do not use any gel or other materials which are not provided by CHISON. Un-authorized
gel, lubricants and other materials may corrode probes and other parts of the device, for example
the keyboard. This may reduce the safety and effectiveness of the system and probes, and may
also reduce the life time of the systems and probes. Damages caused by such reason will not be
covered by the warranty.
DO NOT apply gel to the eyes. If there is gel contact to the eye, flush eye thoroughly with water.
Coupling gels should not contain the following ingredients as they are known to cause probe damage:
Methanol, ethanol, isopropanol, or any other alcohol-based product.
Mineral oil
Iodine
Lotions
Lanolin
Aloe Vera
Olive Oil
Methyl or Ethyl Parabens (para hydroxybenzoic acid)
Dimethylsilicone
151
Planned maintenance
The following maintenance plan is suggested for the system and probes to ensure optimum operation and safety.
Daily: inspect the probes
After each use: clean the probes disinfect the probes.
As necessary: inspect the probes, clean the probes, and disinfect the probes.
Returning/Shipping Probes and Repair Parts
Transportation dept. and our policy require that equipment returned for service MUST be clean and free of
blood and other infectious substances.
When you return a probe or part for service, you need to clean and disinfect the probe or part prior to packing
and shipping the equipment.
Ensure that you follow probe cleaning and disinfection instructions provided in this Manual.
This ensures that employees in the transportation industry as well as the people who receive the package are
protected from any risk.
AIUM outlines cleaning the endocavitary transducer:
Guidelines for Cleaning and Preparing Endocavitary Ultrasound Transducers Between Patients From AIUM
Approved June 4, 2003
The purpose of this document is to provide guidance regarding the cleaning and disinfection of
transvaginal and transrectal ultrasound probes.
All sterilization/disinfection represents a statistical reduction in the number of microbes present on a surface.
Meticulous cleaning of the instrument is the essential key to an initial reduction of the microbial/organic load by at
least 99%. This cleaning is followed by a disinfecting procedure to ensure a high degree of protection from
infectious disease transmission, even if a disposable barrier covers the instrument during use.
Medical instruments fall into different categories with respect to potential for infection transmission. The most
critical level of instruments are those that are intended to penetrate skin or mucous membranes. These require
sterilization. Less critical instruments (often called "semi-critical" instruments) that simply come into contact with
mucous membranes such as fiber optic endoscopes require high-level disinfection rather than sterilization.
Although endocavitary ultrasound probes might be considered even less critical instruments because they are
routinely protected by single use disposable probe covers, leakage rates of 0.9% - 2% for condoms and 8%-81% for
commercial probe covers have been observed in recent studies. For maximum safety, one should therefore perform
152
high-level disinfection of the probe between each use and use a probe cover or condom as an aid in keeping the
probe clean.
There are four generally recognized categories of disinfection and sterilization. Sterilization is the complete
elimination of all forms or microbial life including spores and viruses.
Disinfection, the selective removal of microbial life, is divided into three classes:
High-Level Disinfection - Destruction/removal of all microorganisms except bacterial spores.
Mid-Level Disinfection - Inactivation of Mycobacterium Tuberculosis, bacteria, most viruses, fungi, and some
bacterial spores.
Low-Level Disinfection - Destruction of most bacteria, some viruses and some fungi. Low-level disinfection will
not necessarily inactivate Mycobacterium Tuberculosis or bacterial spores.
The following specific recommendations are made for the use of Endocavitary ultrasound transducers. Users should
also review the Centers for Disease Control and Prevention document on sterilization and disinfection of medical
devices to be certain that their procedures conform to the CDC principles for disinfection of patient care equipment.
1. CLEANING
After removal of the probe cover, use running water to remove any residual gel or debris from the probe. Use a
damp gauze pad or other soft cloth and a small amount of mild non-abrasive liquid soap (household dishwashing
liquid is ideal) to thoroughly cleanse the transducer. Consider the use of a small brush especially for crevices and
areas of angulation depending on the design of your particular transducer. Rinse the transducer thoroughly with
running water, and then dry the transducer with a soft cloth or paper towel.
2. DISINFECTION
Cleaning with a detergent/water solution as described above is important as the first step in proper disinfection since
chemical disinfectants act more rapidly on clean surfaces. However, the additional use of a high level liquid
disinfectant will ensure further statistical reduction in microbial load. Because of the potential disruption of the
barrier sheath, additional high level disinfection with chemical agents is necessary. Examples of such high level
disinfectants include but are not limited to:
2-3.2% glutaraldehyde products (a variety of available proprietary products including "Cidex," "Metricide," or
"Procide").
Non-glutaraldehyde agents including Cidex OPA (o-phthalaldehyde), Cidex PA (hydrogen peroxide &
peroxyacetic acid).
7.5% Hydrogen Peroxide solution.
Common household bleach (5.25% sodium hypochlorite) diluted to yield 500 parts per million chlorine (10 cc
in one liter of tap water). This agent is effective, but generally not recommended by probe manufacturers
because it can damage metal and plastic parts.
153
Other agents such as quaternary ammonium compounds are not considered high level disinfectants and should not
be used. Isopropanol is not a high level disinfectant when used as a wipe and probe manufacturers generally do not
recommend soaking probes in the liquid.
The FDA has published a list of approved sterilants and high level disinfectants for use in processing reusable
medical and dental devices. That list can be consulted to find agents that may be useful for probe disinfection.
Practitioners should consult the labels of proprietary products for specific instructions. They should also consult
instrument manufacturers regarding compatibility of these agents with probes. Many of the chemical disinfectants
are potentially toxic and many require adequate precautions such as proper ventilation, personal protective devices
(gloves, face/eye protection, etc.) and thorough rinsing before reuse of the probe.
3. PROBE COVERS
The transducer should be covered with a barrier. If the barriers used are condoms, these should be no lubricated and
no medicated. Practitioners should be aware that condoms have been shown to be less prone to leakage than
commercial probe covers, and have a six-fold enhanced AQL (acceptable quality level) when compared to standard
examination gloves. They have an AQL equal to that of surgical gloves. Users should be aware of latex-sensitivity
issues and have available no latex-containing barriers.
4. ASEPTIC TECHNIQUE
For the protection of the patient and the health care worker, all endocavitary examinations should be performed with
the operator properly gloved throughout the procedure. Gloves should be used to remove the condom or other
barrier from the transducer and to wash the transducer as outlined above. As the barrier (condom) is removed, care
should be taken not to contaminate the probe with secretions from the patient. At the completion of the procedure,
hands should be thoroughly washed with soap and water.
Note: Obvious disruption in condom integrity does NOT require modification of this protocol. These guidelines
take into account possible probe contamination due to a disruption in the barrier sheath.
In summary, routine high-level disinfection of the endocavitary probe between patients, plus the use of a
probe cover or condom during each examination is required to properly protect patients from infection
during endocavitary examinations. For all chemical disinfectants, precautions must be taken to protect
workers and patients from the toxicity of the disinfectant.
Amis S, Ruddy M, Kibbler CC, Economides DL, MacLean AB. Assessment of condoms as probe covers for
transvaginal sonography. J Clin Ultrasound 2000;28:295-8.
154
Rooks VJ, Yancey MK, Elg SA, Brueske L. Comparison of probe sheaths for endovaginal sonography.
Obstet. Gynecol 1996;87:27-9.
Milki AA, Fisch JD. Vaginal ultrasound probe cover leakage: implications for patient care. Fertil Steril
1998;69:409-11.
Hignett M, Claman P. High rates of perforation are found in endovaginal ultrasound probe covers before
and after oocyte retrieval for in vitro fertilization-embryo transfer. J Assist Reprod Genet 1995;12:606-9.
Sterilization and Disinfection of Medical Devices: General Principles. Centers for Disease Control, Division of
Healthcare Quality Promotion. http://www.cdc.gov/ncidod/hip/sterile/sterilgp.htm (5-2003).
ODE Device Evaluation Information--FDA Cleared Sterilants and High Level Disinfectants with
General Claims for Processing Reusable Medical and Dental Devices, March 2003.
http://www.fda.gov/cdrh/ode/germlab.html (5-2003).
8.3 Probe Operation Instructions
For details on connecting, activating, deactivating, disconnecting, transporting and storing the probes, see Section
3.7 Probes in Chapter 3.
8.3.1 Scanning the Patient
In order to assure optimal transmission of energy between the patient and probe, a conductive gel must be applied
liberally to the patient where scanning will be performed.
After the examination is complete, follow the cleaning and disinfecting, or sterilizing procedures as appropriate.
8.3.2 Operating Transvaginal probe
The transvaginal probe is an endo-cavity probe, for the operation safety, please refer to Care and Maintenance for
cleaning and disinfection.
Transvaginal probe should be used with FDA approved condom or probe cover. See the following instructions to
put the probe into the condom:
CAUTION:
Some patients may be allergic to natural rubber or medical device with rubber contains. FDA suggests that
155
the user to identify these patients and be prepared to treat allergic reactions promptly before scanning.
Only water-solvable solutions or gel can be used. Petroleum or mineral oil-based materials may harm the
cover.
When the transvaginal probe is activated outside patients body, its acoustic output level should be decreased
to avoid any harmful interference with other equipment.
Operation Procedure:
Put on medical sterile glove
Get the condom for the package.
Unfold the condom.
Load some ultrasound gel into condom.
Take the condom with one hand, and put the probe head into the condom.
Fasten the condom on the end of the probe handle.
Confirm the integrity of the condom, and repeat the above steps to the condom if any damage to the condom is
found.
8.3.3 Cleaning and Disinfecting TV Probe
We strongly recommend wearing gloves when cleaning and disinfecting any endocavitary probe.
Every time before and after each exam, please clean the probe handle and disinfect the transvaginal probe
using liquid chemical germicides
If the probe is contaminated with body fluids, you should disinfect the probe after cleaning.
Regard any exam waste as potentially infectious and dispose of it accordingly.
CAUTION:
Since the probe is not waterproof, you should disconnect it from the system before cleaning or disinfecting.
Before and after each exam, please clean the probe handle and disinfect the transvaginal probe using liquid
chemical germicides.
Cleaning
You can clean the transvaginal probe to remove all coupling gel by wiping with a soft cloth and rinsing with
flowing water. Then wash the probe with mild soap in lukewarm water. Scrub the probe as needed and use a soft
cloth to remove all visible residues from the transvaginal probe surface. Rinse the probe with enough clean
potable water to remove all visible soap residues, and let the probe air dry.
CAUTION:
156
Please remove the cover (if any) before cleaning the probe.(The cover like condom is one time
usable).
When cleaning the TV probe, it is important to be sure that all surfaces are thoroughly
cleaned.
Disinfecting
2% Glutaraldehyde-based solutions have been shown to be very effective for this purpose. Cidex is the only
germicide that has been evaluated for compatibility with the material used to construct the probes.
To keep the effectiveness of the disinfection solutions, a thoroughly cleaning must be done to the probe before
the disinfecting, make sure no residues remain on the probe.
Disinfecting Procedure:
Following all precautions for storage, use and disposal, prepare the germicide solution according to the
manufacturers instructions.
Place the cleaned and dried probe to contact with the germicide, being careful not to let the probe drop to the
bottom of the container and thus damage the probe.
After placing/immersing, rotate and shake the probe while it is below the surface of the germicide to eliminate
air pockets. Allow the germicide to remain in contact with the fully immersed probe. For high level
disinfection, follow the manufacturers recommended time.
Following all precautions for storage, use and disposal, prepare the germicide solution according to the
manufacturers instructions.
After removing from the germicide, rinse the probe according to the germicide manufacturers rinsing
instructions.
Flush all visible germicide residues from the probe and allow to air dry.
157
Chapter 9 System Maintenance and Troubleshooting
9.1 Back up information
Caution:
All patient data created is NOT backed-up! It is highly recommended to create a full system backup of
patient data regularly and empty the hard disk (HDD), to ensure the hard disk (HDD) has never
reached its maximum capacity.
NOTE:
To Backup exams to USB DVD/CD+(R)W disk, please confirm that the USB DVD/CD+(R)W storage
medium used is clean and not scratched!
Warning:
Do not disconnect an external USB pen drive without stopping it. Disconnecting without stopping can
lead to data loss on the external device.
9.2 System Care and Maintenance
The system is a precise electrical device. To ensure the best performance and operation of the system, observe
proper maintenance procedures. Contact the local CHISONs Authorized Service Representative for parts or
periodic maintenance inspections.
Inspecting the System
Examine the following on a monthly basis:
Connectors on cables for any mechanical defects.
Entire length of electrical and power cords for cuts or abrasions.
Equipment for loose or missing hardware.
Control panel and keyboard for defects.
To avoid electric shock hazard, do not remove panels or covers from console. This servicing must be performed by
CHISON's authorized service engineer. Failure to do so could serious injury.
If any defect is observed or malfunctions occur, do not operate the equipment but inform CHISONs authorized
158
service engineer for information.
Weekly Maintenance
The system requires weekly care and maintenance to function safely and properly. Clean the following:
LCD monitor
Operator control panel
Footswitch
Printer
Cleaning the System
Prior to cleaning any part of the system, turn off the system power and disconnect the power cord. See Section
3.4.4Power Off in Chapter 3 for more information.
Cleaning Method
Moisten a soft, non-abrasive folded cloth.
Wipe down the top, front, back, and both sides of the system.
NOTE:
Do not spray any liquid directly into the unit.
Do not use acetone/alcohol or abrasives on painted or plastic surfaces.
Cleaning LCD Monitor
To clean the monitor face:
Use a soft, folded cloth. Gently wipe the monitor face.
Do NOT use a glass cleaner that has a hydrocarbon base (such as Benzene, Methyl Alcohol or Methyl Ethyl
Ketone) on monitors with the filter (anti-glare shield). Hard rubbing will also damage the filter.
NOTE:
When cleaning the screen, make sure not to scratch the LCD.
Cleaning Control Panel
Moisten a soft, non-abrasive folded cloth with a mild, general purpose, non-abrasive soap and water solution.
Wipe down operator control panel.
Use a cotton swab to clean around keys or controls. Use a toothpick to remove solids from between keys and
controls.
NOTE:
159
When cleaning the operator control panel, make sure not to spill or spray any liquid on the
controls, into the system cabinet, or in the probe connection receptacle.
DO NOT use Tspray or Sani Wipes on the control panel.
Cleaning Footswitch
Moisten a soft, non-abrasive folded cloth with a mild, general purpose, non-abrasive soap and water solution.
Wipe the external surfaces of the unit then dry with a soft, clean cloth.
Cleaning Printer
Turn off the power. If possible, disconnect the power cord.
Wipe the external surfaces of the unit with a soft, clean, dry cloth.
Remove stubborn stains with a cloth lightly dampened with a mild detergent solution.
NOTE:
Never use strong solvents, such as thinner or benzine, or abrasive cleansers because they
will damage the cabinet.
No further maintenance, such as lubrication, is required.
For more information, see the Printer's Operation Manual.
9.3 Safety Check
To ensure the system work normally, please make a maintenance plan, check the safety of the system
periodically. If there is any abnormal phenomenon with the machine, please contact our authorized agent in
your country as soon as possible.
If there is no image or menu on the screen or other phenomenon appears after switching on the machine, please
do troubleshooting first according to the following check list. If the trouble is still not solved, please contact
our authorized agent in your country as soon as possible.
9.4 Troubleshooting
It is necessary to maintain the system regularly, as it can ensure the system being operated under safe state by
eliminating possible trouble, and it can shorten the checking and repair period, lower the service costs and
reduce the operation danger.
If you have any difficulty with the system, use the following information for your reference to help correct the
problem. For a problem not covered here, contact your local distributor or Manufacturer.
160
Symptom Solution
The system cant power on 1) Check power connections, e.g. power cord connection on the rear panel;
2) Check the fuse: if it is burnt due to mains fluctuation, use spare fuse for
replacement.
When starting the system, the
monitor has signal but no
ultrasound image
Switch off the system, and check probe connection.
System image quality is not good 1) Adjust the LCD monitor position for a better viewing angle;
2) Adjust the brightness and contrast of LCD monitor;
3) Adjust the image parameters, e.g. Gain, Dynamic range.
No OB calculation package menu Select the OB application before scanning.
PRINT-key doesnt work 1) Check if the approved printer is connected;
2) Check if the printer power is on;
3) Check printer connection;
4) Check printer setting in system setup.
External monitor doesnt work 1) Check the monitor connections;
2) Check if the monitor power is on and is set up correctly.
CFM or PW Doppler image has
noise
1) Adjust CFM or PW gain value properly;
2) Check if there is appliance or equipment resulting in strong
electromagnetic interference
Image has interference 1) Move or avoid interference source;
2) Use separate power outlet;
3) Perform good ground protection
The gray scale is S- twisted in the
image area
Adjust the power supply to normal voltage or use a voltage stabilizer
The date and time on the screen is
not correct
Press Setup-key to display General Setting screen, and correct time and date.
The Video printer is not work 1) Please confirm the signal cable, Remote cable are connected well.
2) Please make sure you have finished the setting for Video printer at system
interface.
3) If you cant change the setting at system interface, please check whether
the video printer is turned on and connected well with the main unit.
4Please make sure the switch on the rear panel of printer is on status.
9.5 Service Responsibility
If users install, use and maintain the system fully according to CHISONs installation manual,
operation manual and service manual, then CHISON Q9 main unit has a life time of 5 years and
161
CHISON Q9 probes have life time of 5 years after ex-work (except that the 4D probe V4C40L
life time is 18 months).
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 CHISONs 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 CHISONs authorized service engineer during the life time of the product.
CAUTION: When the above life time is expired, the effectiveness
and safety of system and probes maybe greatly affected, so its 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 CHISONs 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 its suggested to renew the product after the life time.
REFERENCE:
1) AIUM/NEMA: Standard For Real-Time Display of Thermal and Mechanical Acoustic Output
Indices On Diagnostic Ultrasound Equipment, Revision 2. NEMA Standards Publication UD
3-2004; American Institute of Ultrasound in Medicine, Laurel MD; National Electrical
Manufacturers Association, Rosslyn, VA; 2004a.
162
2) Implementation of the Principle of As Reasonably Achievable (ALARA) for Medical and Dental Personnel,
National Council on Radiation Protection and Measurements (NCRP), report NO.107, December 31,1990
3) FDA Center for Devices and radiological Health (CDRH), 510(K) Guidance for Diagnostic Ultrasound and
Fetal Doppler Ultrasound Medical Devices, September 8 1989 draft
4) FDA/CDRH,510(K) Diagnostic Ultrasound Guidance Update of 1991, April 26, 1991 draft
5) Biological Effects of Ultrasound: Mechanisms and Clinical Implications, NCRP Report No. 74, December
30,1983
6) Exposure Criteria for Medical Diagnostic Ultrasound: I. Criteria Based on Thermal Mechanisms, NCRP
Report No.113, June 1,1992
7) Bioeffects Considerations for the safety of Diagnostic Ultrasound, Journal of Ultrasound in Medicine, AIUM,
September1988
8) Geneva Report on Safety and Standardization in Medical Ultrasound, WFUMB, May 1990 Medical
Ultrasound Safety, AIUM, 1994
9) Medical Electrical Equipment standard IEC 60601-1, IEC60601-1-1, IEC60601-1-2, IEC 60601-2-37, IEC
60601-2-4
10) Diagnostic Ultrasound Physics and Equipment, edit by P. R. Hoskins, in 2003
163
Appendix A The Information of CE Representative
Shanghai International Holding Corp.GmbH(Europe)
Add: Eiffestrasse 80,20537 Hamburg,Germany
Tel: 0049-40-2513175
Fax:0049-40-255726
E-mail: antonsissi@hotmail.com shholding@hotmail.com
164
Appendix B System one-key-recovery Function
This system has one-key-recovery function. User can use this function to recovery system when the system has
problems.
Detailed operations are as follows:
1. Press button to boot the system.
2. Press button when the system enter into the following boot screen.
3. When the recovery system starts, the following interface will pop up, users can select language,
Choose to whether to recovery the system.
System Recovery: Recovery the system
Exit : Exit the system recovery
165
4. After click Chison System Recovery, the system will start to backup ultrasound system data, after finishing the
backup, the system will transfer to the recovery procedure automatically, and the following interface will pop up.
Click OK to confirm and start the recovery.
Click Cancel to cancel the system recovery, and go back to the CMD interface.
5. After finishing the recover, the system will pop the CMD interface. Input EXIT in the command line to reboot the
system will reboot.
Note:
After recovering the system successfully, users need to set "display Settings" manually to ensure
video printer work properly
Setting procedures are as follows:
Press Set-up key to enter into the setting interface, select the system interface, and click display setting
166
Callout the display setting interface, and set up Operating Mode and Display Selection respectively.
Click OK , the following interface will pop up, and click OK again to confirm it.
167
168
Appendix C MAXIMUMACOUSTIC OUTPUT REPORT
Acoustic Output Table
System: Q9
Transducer Model: D3C60L-B Operating Mode: B
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Global Maximum Index Value 0.84 0.02
Associated
Acoustic
Parameter
Pra Mpa 1.47
P mW 4
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
Z at max.Ipi.a cm 4.89
deq(Zb) cm
fawf MHz 3.24 3.58
Dim
of
Aaprt
X cm 3.52
Y cm 1.1
Other
Informatio
n
td s 0.78
prr Hz 235
pr at max.Ipi MPa 2.39
deq at max.Ipi cm
Ipa.a at max.MI W/cm
2
71.45
Operating
Control
Conditions
Focus position cm 6 2
A Power % 100 100
169
System: Q9
Transducer Model: D3C60L-B Operating Mode: C
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.07
P mW 49.6
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
deq(Zb) cm
fawf MHz 3.92 3.92
Dim of
Aaprt
X cm 1.71
Y cm 1.1
Other
Information
td s 1.27
prr Hz 1194
deq at max.Ipi cm
2
31.24
Operating
Control
Conditions
A Power % 100 100
170
System: Q9
Transducer Model: D3C60L-B Operating Mode: M
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Global Maximum Index Value 0.774 0.07 0.16
Associated
Acoustic
Parameter
Pra Mpa 1.477
P mW 21.32 32
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 4.45
deq(Zb) cm 1.99
fawf MHz 3.52 3.52 3.51
Dim of
Aaprt
X cm 6.84 6.84
Y cm 1.1 1.1
Other
Information
td s 0.42
prr Hz 164
deq at max.Ipi cm 1.95
2
52.65
Operating
Control
Conditions
Focus position cm 5 5 7
A Power % 100 100 100
171
System: Q9
Transducer Model: D3C60L-B Operating Mode: PD
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.00
P mW 40 36
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 4.97
deq(Zb) cm 0.23
fawf MHz 2.89 2.86 2.89
Dim of
Aaprt
X cm 6.84 6.84
Y cm 1.1 1.1
Other
Information
td s 1.23
prr Hz 4376
2
36.64
Operating
Control
Conditions
A Power % 100 100 100
172
System: Q9
Transducer Model: D3P64L Operating Mode: B
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.47
P mW 4
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
deq(Zb) cm
fawf MHz 3.24 3.58
Dim of
Aaprt
X cm 3.52
Y cm 1.1
Other
Information
td s 0.78
prr Hz 2376
deq at max.Ipi cm
2
71.44
Operating
Control
Conditions
A Power % 100 100
173
System: Q9
Transducer Model: D3P64L Operating Mode: C
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.07
P mW 49.6
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
deq(Zb) Cm
fawf MHz 3.92 3.92
Dim of
Aaprt
X cm 1.71
Y cm 1.1
Other
Information
td s 1.27
prr Hz 1194
deq at max.Ipi cm
2
31.45
Operating
Control
Conditions
A Power % 100 100
174
System: Q9
Transducer Model: D3P64L Operating Mode: M
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.51
P mW 21.32 32.54
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 4.23
deq(Zb) cm 1.99
fawf MHz 3.54 3.52 3.51
Dim of
Aaprt
X cm 6.84 6.84
Y cm 1.1 1.1
Other
Information
td s 0.42
prr Hz 164
deq at max.Ipi Cm 1.95
2
52.87
Operating
Control
Conditions
A Power % 100 100 100
175
System: Q9
Transducer Model: D3P64L Operating Mode: PD
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.00
P mW 40 36
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 4.54
deq(Zb) cm 0.23
fawf MHz 2.89 2.86 2.89
Dim of
Aaprt
X cm 6.84 6.84
Y cm 1.1 1.1
Other
Information
td s 1.23
prr Hz 4376
2
36.63
Operating
Control
Conditions
A Power % 100 100 100
176
System: Q9
Transducer Model: D7L40L Operating Mode: B
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.095
P mW 2
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
Z at max.Ipi.a cm 2
deq(Zb) cm
fawf MHz 6.049 7.714
Dim of
Aaprt
X cm 0.4229
Y cm 0.1475
Other
Information
td s 0.195
prr Hz 6024
deq at max.Ipi cm
2
29.638
Operating
Control
Conditions
Focus position cm 2.5 0.5
A Power % 100 100
177
System: Q9
Transducer Model: D7L40L Operating Mode: C
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.19
P mW 48
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
Z at max.Ipi.a cm 2
deq(Zb) cm
fawf MHz 5.863 7.61
Dim of
Aaprt
X cm 0.177
Y cm 0.2549
Other
Information
td s 0.196
prr Hz 12100
deq at max.Ipi cm
2
51.49
Operating
Control
Conditions
A Power % 100 100
178
System: Q9
Transducer Model: D7L40L Operating Mode: M
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.289
P mW 16 16
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 2.25
Z at max.Ipi.a cm 2
deq(Zb) cm 0.258
fawf MHz 6.219 6.982 6.982
Dim of
Aaprt
X cm 0.2936 0.2396
Y cm 0.1686 0.1686
Other
Information
td s 0.166
prr Hz 2336.4
2
54.798
Operating
Control
Conditions
Focus position cm 4.5 3.5 3.5
A Power % 100 100 100
179
System: Q9
Transducer Model: D7L40L Operating Mode: PD
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 0.596
P mW 46 46
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 1.209
Z at max.Ipi.a cm 2
deq(Zb) cm 0.484
fawf MHz 7.922 8.158 8.158
Dim of
Aaprt
X cm 0.3613 0.3613
Y cm 0.1062 0.1062
Other
Information
td s 0.471
prr Hz 7168
2
11.52
Operating
Control
Conditions
A Power % 100 100 100
180
System: Q9
Transducer Model: D6C12L Operating Mode: B
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.147
P mW 4
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
Z at max.Ipi.a cm 2
deq(Zb) cm
fawf MHz 4.649 5.147
Dim of
Aaprt
X cm 0.3479
Y cm 0.4447
Other
Information
td s 0.257
prr Hz 2614
pr at max.Ipi MPa 5489
deq at max.Ipi cm
2
44.912
Operating
Control
Conditions
A Power % 100 100
181
System: Q9
Transducer Model: D6C12L Operating Mode: C
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.44
P mW 14
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
Z at max.Ipi.a cm 2
deq(Zb) cm
fawf MHz 5.486 5.486
Dim of
Aaprt
X cm 0.2895
Y cm 0.2679
Other
Information
td s 0.264
prr Hz 10400
deq at max.Ipi cm
2
0.346
Operating
Control
Conditions
A Power % 100 100
182
System: Q9
Transducer Model: D6C12L Operating Mode: M
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.84
P mW 8 8
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 2
Z at max.Ipi.a cm 2
deq(Zb) cm 0.177
fawf MHz 4.515 4.54 4.54
Dim of
Aaprt
X cm 0.1964 0.1964
Y cm 0.3193 0.3193
Other
Information
td s 0.297
prr Hz 2379
2
97.144
Operating
Control
Conditions
A Power % 100 100 100
183
System: Q9
Transducer Model: D6C12L Operating Mode: PD
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.208
P mW 72 102
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 2.05
Z at max.Ipi.a cm 2
deq(Zb) cm 0.588
fawf MHz 6.211 6.24 6.105
Dim of
Aaprt
X cm 0.4378 0.386
Y cm 0.2959 0.3095
Other
Information
td s 0.648
prr Hz 6098
2
47.381
Operating
Control
Conditions
A Power % 100 100 100
184
System: Q9
Transducer Model: D12L40L Operating Mode: B
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.495
P mW 4
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
Z at max.Ipi.a cm 2
deq(Zb) cm
fawf MHz 11.049 11.714
Dim of
Aaprt
X cm 0.4229
Y cm 0.1475
Other
Information
td s 0.145
prr Hz 6024
deq at max.Ipi cm
2
49.638
Operating
Control
Conditions
A Power % 100 100
185
System: Q9
Transducer Model: D12L40L Operating Mode: C
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.19
P mW 48
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
Z at max.Ipi.a cm 2
deq(Zb) cm
fawf MHz 11.863 11.61
Dim of
Aaprt
X cm 0.177
Y cm 0.2549
Other
Information
td s 0.146
prr Hz 12400
deq at max.Ipi cm
2
41.49
Operating
Control
Conditions
A Power % 100 100
186
System: Q9
Transducer Model: D12L40L Operating Mode: M
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 1.289
P mW 16 16
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 2.25
Z at max.Ipi.a cm 2
deq(Zb) cm 0.258
fawf MHz 11.219 11.982 11.982
Dim of
Aaprt
X cm 0.2936 0.2396
Y cm 0.1686 0.1686
Other
Information
td s 0.146
prr Hz 2306.4
2
34.798
Operating
Control
Conditions
A Power % 100 100 100
187
System: Q9
Transducer Model: D12L40L Operating Mode: PD
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 0.546
P mW 46 46
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm 1.209
Z at max.Ipi.a cm 2
deq(Zb) cm 0.484
fawf MHz 11.922 11.158 11.158
Dim of
Aaprt
X cm 0.3613 0.3613
Y cm 0.1062 0.1062
Other
Information
td s 0.471
prr Hz 6168
2
10.52
Operating
Control
Conditions
A Power % 100 100 100
188
System: Q9
Transducer Model: V4C40L Operating Mode: B
Index Label MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
Aaprt
1cm
2
Aaprt
1cm
2
Associated
Acoustic
Parameter
Pra Mpa 2.198
P mW 2
Min of [Pa(Zs),
Ita.a(Zs) ]
mW
Zs cm
Zbp cm
Zb cm
deq(Zb) cm
fawf MHz 3.4 3.53
Dim of
Aaprt
X cm 1
Y cm 0.6439
Other
Information
td s 0.578
prr Hz 3623.3
deq at max.Ipi cm
2
140.286
Operating
Control
Conditions
A Power % 100 100
189
Display Accuracy and Acoustic Measurement Uncertainties
According to IEC60601-2-37 and NEMA UD-3 2004, the display accuracy and acoustic measurement uncertainties are
summarized in the table below.
Display accuracy of MI is 20%, and TI is 40% or <0.1, if MI,TI below 0.5.
Item
Measurement Uncertainty
(Percentage, 95% Confidence Value
Center Frequency 5%
Acoustic Power 30%
Acoustic Intensity 30%
Peak Rarefactional Pressure 15%
190
APPENDIX D Transducer Maximum Surface Temperature
According to the requirements of the section 42.3 in the standard IEC 60601-2-37:2007,the transducer surface
temperature has been tested in two kinds of conditions: the transducer suspended in still air or transducer contacting
human-tissue mimicking material. The calculation of the expanded uncertainty is based on the ISO Guide tout ye
Expression of uncertainty in measurement. Three transducer samples have been tested and the confidence coefficient is
at 95%,the value of t.975 is 4.30.
The measurement data were obtained under the test conditions employed at CHISON.
Transducer
model
Ambient
()
Maximum surface
temperature()
Contacting human-tissue
mimicking material
Maximum surface
temperature()
Suspending in air
D3C60L
25 331 471
D7L40L
25 321 392
D6C12L
25 291 452
D6C15L
25 331 432
D3C20L
25 331 462
V4C40L
25 311 392
Note: Values following the mark indicate the expanded uncertainty with a confidence lever of
95%,t.975=4.30.
191
APPENDIX E GUIDANCE AND MANUFACTURERS DECLARATION
2. Guidance and manufacturers declaration electromagnetic immunity
The Q9 is intended for use in the electromagnetic environment the Q9 should assure that it is used in
such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic
environment
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for input/output
lines
2 kV for power
supply lines
1 kV for input/output
lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
1. Guidance and manufacturers declaration electromagnetic emissions
The Q9 is intended for use in the electromagnetic environment specified below. The customer or
the user of the Q9 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic
environment guidance
RF emissions
CISPR 11
Group 1 The Q9 uses RF energy only
for its internal function.
Therefore, its RF emissions
are very low and are not likely
to cause any interference in
nearby electronic
equipment.
RF emissions
CISPR 11
Class A The Q9 is suitable for use in
all establishments, including
domestic stablishments and
those directly connected to the
public low-voltage power
supply network
that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
192
Surge
IEC 61000-4-5
1 kV line(s) to
line(s)
2 kV line(s) to earth
1 kV line(s) to
line(s)
2 kV line(s) to earth
Mains power quality
should be that
of a typical commercial or
hospital
environment.
interruptions
and
voltage
variations
on power
supply
input lines
IEC
61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Mains power quality
should be that
of a typical commercial or
hospital
environment. If the user of
the
Q9 requires
continued operation during
power
mains interruptions, it is
recommended that the Q9
be powered from an
uninterruptible power
supply or a
battery.
Power
frequency
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
193
3 Guidance and manufacturers declaration electromagnetic immunity
The Q9 is intended for use in the electromagnetic environment specified below. The customer or the
user of the Q9 should assure that it is used in such an environment.
3.1. Immunity
Test
IEC 60601 test
level
IEC 60601 test
level
Electromagnetic environment guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Q9, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios,amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Q9 is used exceeds the applicable RF compliance level above, the Q9 should
be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the Q9.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
194
portable and mobile RF communications equipment and the Q9
The Q9 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Q9 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Q9 as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output
power of transmitter
W
Separation distance according to frequency of transmitter
m
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and
reflection from structures, objects and people.
195
APPENDIX F MEASUREMENT RESULTS SUMMARY
Measurement Useful Range Accuracy
Distance Full Screen <5%
Circumference:
trace method,ellipse method
Full Screen <5%
Area:
trace method,ellipse method
Full Screen <10%
Volume Full screen <10%
Angle Full screen <5%
Time Full Screen <5%
Heart rate Full Screen <5%
Velocity Full Screen <10%

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