Chison Q9 Operation 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.
Q9 Digital Color Doppler Ultrasound System
Regulatory Requirement
This product conforms to the essential requirements of the Medical Device
Directive 93/42/EEC. Accessories without the CE mark are not guaranteed to
meet the Essential Requirements of the Medical Device Directive.
This manual is a reference for the 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.
Q9 Digital Color Doppler Ultrasound System
Important information
1. It is the customer’s responsibility to maintain and manage the system after delivery.
2. The warranty does not cover the following items, even during the warranty period:
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 don’t
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 CHISON’s 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 physician’s 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.
Q9 Digital Color Doppler Ultrasound System
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 CHISON’s authorized service engineer
to make sure it’s 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.
Q9 Digital Color Doppler Ultrasound System
TABLE OF CONTENTS
C
HAPTER
1 I
NTRODUCTION
.................................................................................................................................................... 1
1.1 System Overview............................................................................................................................................................ 1
1.2 Contact Information........................................................................................................................................................ 1
C
HAPTER 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
C
HAPTER 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
C
HAPTER
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 ........................................................................................................................................ 61
C
HAPTER 5 GENERAL MEASUREMENTS
...................................................................................................................................... 75
5.1 Key for Measurement ............................................................................................................................................... 75
5.2 Fast measurement...................................................................................................................................................... 76
5.3 Measurement and Calculation ................................................................................................................................... 80
5.4 Edit measurement results ........................................................................................................................................ 118
5.5 Report ..................................................................................................................................................................... 118
C
HAPTER 6 PRESET
.................................................................................................................................................................. 121
6.1. Recall Preset ................................................................................................................................................................. 121
6.2. Save user defined preset ............................................................................................................................................... 121
6.3. Manage Preset .............................................................................................................................................................. 122
C
HAPTER 7 SYSTEM SETTING
................................................................................................................................................. 123
7.1. General settings ............................................................................................................................................................ 123
7.2 Measurement ................................................................................................................................................................. 125
7.3 Comment: ...................................................................................................................................................................... 127
7.4 Report ............................................................................................................................................................................ 128
7.5 Network ......................................................................................................................................................................... 131
7.6 System ........................................................................................................................................................................... 135
C
HAPTER 8 PROBES
.................................................................................................................................................................. 145
8.1. General Description ...................................................................................................................................................... 145
8.2. Care and Maintenance .................................................................................................................................................. 145
8.3 Probe Operation Instructions ......................................................................................................................................... 154
C
HAPTER 9 SYSTEM MAINTENANCE AND TROUBLESHOOTING
................................................................................................. 157
9.1 Back up information ................................................................................................................................................... 157
Q9 Digital Color Doppler Ultrasound System
9.2 System Care and Maintenance ................................................................................................................................... 157
9.3 Safety Check ............................................................................................................................................................... 159
9.4 Troubleshooting .......................................................................................................................................................... 159
9.5 Service Responsibility ................................................................................................................................................ 160
A
PPENDIX A THE INFORMATION OF CE REPRESENTATIVE
................................................................................................... 163
A
PPENDIX B SYSTEM ONE-KEY-RECOVERY FUNCTION
........................................................................................................ 164
A
PPENDIX C
MAXIMUM ACOUSTIC OUTPUT REPORT .............................................................................................. 168
APPENDIX D
TRANSDUCER MAXIMUM SURFACE TEMPERATURE
........................................................................................ 190
APPENDIX E
GUIDANCE AND MANUFACTURER’S DECLARATION........................................................................ 191
APPENDIX F
MEASUREMENT RESULTS SUMMARY .................................................................................................. 195
Q9 Digital Color Doppler Ultrasound System
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.
Q9 Digital Color Doppler Ultrasound System
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Chapter 2 System Safety
2.1 Safety Overview
This section discusses the measures to ensure the safety of both the operator and patient. To ensure the safety of both
operator and patient, please read the relevant details in this chapter carefully before operating this system.
Disregarding the warnings or violation of relevant rules may result in personal injury for operator or patient. or even
loss of life
Users should observe the following precautions:
This system complies with Type BF general equipment, and the IEC standard. Please follow 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.
Q9 Digital Color Doppler Ultrasound System
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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 CHISON’s Authorized Service
Representative.
2.2 Electrical Safety
Type of protection against electric shock
Class I Equipment
CLASS I EQUIPMENT in which protection against electric shock does not rely on basic insulation only, but which
includes an additional safety precaution in that accessible conductive parts are connected to the protective earthing
conductor in the electrical installation in such a way that accessible parts cannot become live in the event of a failure of
the basic insulation.
Degree of protection against electric shock
Type BF Applied part (for Probes marked with BF symbol)
TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular regard to
allowable LEAKAGE CURRENT
BF: Isolation from ground; max. Patient leakage current: normal mode ≤100 µA, single fault condition ≤ 500 µA
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.
Q9 Digital Color Doppler Ultrasound System
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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)
Q9 Digital Color Doppler Ultrasound System
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)
Q9 Digital Color Doppler Ultrasound System
6
accompanied by the name a
nd 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 panel
（refer to Fig.3-1c in Chapter3）:
1 Footswitch port
1 Remote port
2 Probe ports
CAUTION:
Q9 Digital Color Doppler Ultrasound System
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VIDEO, S–VIDEO 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 can’t be used with HF surgical equipment; otherwise the burns to patient may occur.
Any device connected to this system must conform to one or more of the requirements listed
below:
IEC standard or equivalent standards appropriate to devices.
The devices shall be connected to PROTECTIVE EARTH (GROUND).
CAUTION:
Unsafe operation or malfunction may occur. Use only the accessories, options and
supplies approved or recommended in these instructions for use.
Peripheral used in the patient environment
The system has been verified for overall safety, compatibility and compliance with the following on-board image
recording devices:
B/W video printer: 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
Q9 Digital Color Doppler Ultrasound System
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 user’s responsibility to ensure the USB disk or removable media is virus-free.
Improper use of USB disk or removable media may cause the virus infections of system and eventually malfunction
may occur. Such malfunction may impact the stability, effectiveness and safety of the system and probes, and users
should immediately stop using the system and probes until CHISON authorized engineer has checked the system
and confirm the effectiveness and safety of the system and probes.
CAUTION:
Use only secure Local Area Network connection. Don’t connect the ultrasound system to Internet.
Make sure your hospital’s firewall software is configured correctly, thus blocking incoming connection requests
from Internet. Improper use of network connection may cause the virus infections of system and eventually
malfunction may occur.
2.5 Biological Safety
This product, as with all diagnostic ultrasound equipment, should be used only for valid reasons and should be used
both for the shortest period of time and at the lowest power settings necessary (ALARA - As Low As Reasonably
Achievable) to produce diagnostically acceptable images. The AIUM offers the following guidelines:
Clinical Safety Quoted from AIUM
Q9 Digital Color Doppler Ultrasound System
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Approved March 26, 1997
Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized
efficacy for medical diagnosis, including use during human pregnancy, the American Institute of
Ultrasound in Medicine herein addresses the clinical safety of such use:
There are no confirmed biological effects on patients or instrument operators caused by exposures
from present diagnostic ultrasound instruments. Although the possibility exists that such biological
effects may be identified in the future, current data indicate that the benefits to patients of the prudent
use of diagnostic ultrasound outweigh the risks, if any that may be present.
Heating:
Elevating tissue temperature during obstetrical examinations creates medical concerns. At the embryo
development stage, the rise in temperature and the length of time exposed to heat combine to determine potential
detrimental effects. Exercise caution particularly during Doppler/Color exams. The Thermal Index (TI) provides a
statistical estimate of the potential temperature elevation (in centigrade) of tissue temperature. Three forms of TI are
available: Soft Tissue Thermal Index (TIS), Bone Thermal Index (TIB) and Cranial Bone Thermal Index (TIC).
Soft Tissue Thermal Index (TIS). Used when imaging soft tissue only, it provides an estimate of potential
temperature increase in soft tissue.
Bone Thermal Index (TIB). Used when bone is near the focus of the image as in the third trimester OB examination,
it provides an estimate of potential temperature increase in the bone or adjacent soft tissue.
Cranial Bone Thermal Index (TIC). Used when bone is near the skin surface as in transcranial examination, it
provides an estimate of potential temperature increase in the bone or adjacent soft tissue.
Cavitations:
Cavitations may occur when sound passes through an area that contains a cavity, such as a gas bubble
or air pocket (in the lung or intestine, for example). During the process of cavitations, the sound wave may cause the
bubble to contract or resonate. This oscillation may cause the bubbles to explode and damage the tissue. The
Mechanical Index (MI) has been created to help users accurately evaluate the likelihood of cavitations and the
related adverse effects.
MI recognizes the importance of non-thermal processes, cavitations in particular, and the Index is an attempt to
indicate the probability that they might occur within the tissue.
2.6 Scanning Patients and Education
The Track-3 or IEC60601-2-37 output display standard allows users to share the responsibility for the safe use of this
ultrasound system. Follow these usage guidelines for safe operation:
In order to maintain proper cleanliness of the probes, always clean them between patients.
Always use a disinfected sheath on all EV/ER probes during every exam.
Continuously move the probe, rather than staying in a single spot, to avoid elevated temperatures in one part of
the patient’s body.
Move probe away from the patient when not actively scanning.
Q9 Digital Color Doppler Ultrasound System
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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
Q9 Digital Color Doppler Ultrasound System
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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/cm2. An
exception is for ophthalmic use, in which case the TI = max (TIS_as, TIC) is not to exceed 1.0; Ispta.3
≤50mW/cm2,
Q9 Digital Color Doppler Ultrasound System
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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 2.5°C must be
present consistently at one spot for 2 hours to cause fetal abnormalities. Avoiding a local temperature rise
above 1°C should ensure that no thermally induced biologic effect occurs. When referring to the TI for
potential thermal effect, a TI equal to 1 does not mean the temperature will rise 1 degree C. It only means an
increased potential for thermal effects can be expected as the TI increases. A high index does not mean that bioeffects
are occurring, but only that the potential exists and there is no consideration in the TI for the scan duration, so
minimizing the overall scan time will reduce the potential for effects. These operator control and display features shift
the safety responsibility from the manufacturer to the user. So it is very important to have the Ultrasound systems
display the acoustic output indices correctly and the education of the user to interpret the value appropriately.
RF: (De-rating factor)
In Situ intensity and pressure cannot currently be measured. Therefore, the acoustic power measurement is normally
done in the water tank, and when soft tissue replaces water along the ultrasound path, a decrease in intensity is
expected. The fractional reduction in intensity caused by attenuation is denoted by the de-rating factor (RF),
RF = 10
(-0.1 a f z)
Where a is the attenuation coefficient in dB cm-1 MHz-1, f is the transducer center frequency, and z is the distance
along the beam axis between the source and the point of interest.
De-rating factor RF for the various distances and frequencies with attenuation coefficient 0.3dB cm-1 MHz-1 in
homogeneous soft tissue is listed in the following table. An example is if the user uses 7.5MHz frequency, the power will
be attenuated by .0750 at 5cm, or 0.3x7.5x5=-11.25dB. The De- rated Intensity is also referred to as ‘.3’ at the end (e.g.
Ispta.3).
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
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8 0.5754
0.1903
0.0631
0.0158
I’=I*R
F
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 (>1cm2)
Liver PW
2 TIS Soft tissue Unscanned
Small aperture (<1cm2)
Pencil Probe
3 TIS Soft tissue Scanned Evaluated at surface Breast color
4 TIB Soft tissue and bone Scanned Soft tissue at surface Muscle color
5 TIB Soft tissue and bone Unscanned Bone at focus Fetus head PW
6 TIC Soft tissue and bone Unscanned/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 1°C (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 1°C 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.
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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
Q9 Digital Color Doppler Ultrasound System
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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.
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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: 10º C ~ 40º 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.
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3.1.2. Transport and Storage Environmental Requirements
The following environmental transport and storage conditions are within system tolerances:
Temperature: -5º C ~ 40º 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 can’t 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
guidelines—failure 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
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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
VGA port
TV port
LAN port
S-Video
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Fig. 3-1 c: System Back view
3.2.2. Physical Specification
Dimensions of main unit (approx.): 370mm（Length）*185mm（Width）*395mm（Height）
Net weight of main unit (approx): <11KG (no probe included)
3.2.3. Key System Features
Display B（2D）、B/B、4B、B/M、M、PWD、CFM、CPA、DPD、CW、Steer M、Color M 、TDI、
B/BC、HPRF、Triplex、Panoramic imaging、THI、Trapezoid Imaging、4D
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-ImageTM 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;
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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 user’s 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
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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
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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 º increment if its temperature is below 10 ºC or
above 40 ºC.
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.
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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.
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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 probe’s carrying case on a stable surface and open the case.
Carefully remove the probe and unwrap the probe cord.
DO NOT allow head of the probe hang freely. Impact to head of the probe could result in irreparable
damage.
NOTE:
Inspect the probe before and after each use for damage or degradation to the housing,
strain relief, lens, seal and connector. DO NOT use a probe that appears damaged until its
functional and safe performance is verified. A thorough inspection should be performed
during the cleaning process.
Align the connector with the probe port and carefully push into place with the cable facing the back of the
system.
Turn the probe connector locking lever to “lock” status.
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