Digital Color Doppler Ultrasound System: Model
Digital Color Doppler Ultrasound System: Model
Digital Color Doppler Ultrasound System: Model
Model
Q9
OPERATION MANUAL
Direction: CHUMQ9-001
V1.0
December 10, 2013
Regulatory Requirement
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
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.
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.
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Q9 Digital Color Doppler Ultrasound System
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
NOTE:
*To dispose of this product properly, please contact the local CHISON’s Authorized Service
Representative.
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.
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Q9 Digital Color Doppler Ultrasound System
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.
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.
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Q9 Digital Color Doppler Ultrasound System
2.3 Labels
Caution, consult accompanying documents. Dangerous electric voltage. Unplug the main plug
This symbol advises the reader to consult the before opening the system!
accompanying documents for important safety related
information such as warnings and pre-cautions that
Cannot be presented on the device itself.
IPX7 IPX0
Protection against the effects of immersion (probes) No protection against ingress of water (system)
Rx only
This symbol indicates that in the united states of This symbol is followed by the manufacturing date of the
America, Federal law restricts the device to sale by or on device in the form YYYY-MM.
the order of a licensed practitioner or therapist.
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Q9 Digital Color Doppler Ultrasound System
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:
CAUTION: Unsafe operation or malfunction may occur. Use only the accessories, options and
supplies approved or recommended in these instructions for use.
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
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Q9 Digital Color Doppler Ultrasound System
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.
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.
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:
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Q9 Digital Color Doppler Ultrasound System
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.
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.
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Q9 Digital Color Doppler Ultrasound System
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).
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
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Q9 Digital Color Doppler Ultrasound System
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:
Maximum exposure
TI
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.
Track-3 follows the Output Display Standard for systems that include fetal Doppler applications. The acoustic output
will not be evaluated on an application-specific basis, but the global maximum de-rated Ispta must be ≤ 720 mW/cm2
and either the global maximum MI must be ≤ 1.9 or the global maximum de-rated Isppa must be ≤ 190 W/cm2. An
exception is for ophthalmic use, in which case the TI = max (TIS_as, TIC) is not to exceed 1.0; Ispta.3 ≤50mW/cm2,
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Q9 Digital Color Doppler Ultrasound System
and MI ≤ 0.23. Track-3 gives the user the freedom to increase the output acoustic power for a specific exam, and still
limit output acoustic power within the global maximum de-rated Ispta ≤ 720 mW/cm2 under an Output Display
Standard.
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 = 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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Q9 Digital Color Doppler Ultrasound System
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
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 (Wdeg), TI = W.3/Wdeg.
Three TIs corresponding to soft tissue (TIS) for abdominal; bone (TIB) for fetal and neonatal cephalic; and cranial
bone (TIC) for pediatric and adult cephalic, have been developed for applications in different exams.
An estimate of the acoustic power in milli-watts necessary to produce a 1°C temperature elevation in soft tissue is:
Wdeg = 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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Q9 Digital Color Doppler Ultrasound System
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).
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’.
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.
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Q9 Digital Color Doppler Ultrasound System
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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Q9 Digital Color Doppler Ultrasound System
The following environmental transport and storage conditions are within system tolerances:
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.
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Q9 Digital Color Doppler Ultrasound System
Handle
S-Video
USB port
LAN port
VGA port
LCD monitor
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Q9 Digital Color Doppler Ultrasound System
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Q9 Digital Color Doppler Ultrasound System
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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Q9 Digital Color Doppler Ultrasound System
V4C40L
Foot switch
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.
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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Q9 Digital Color Doppler Ultrasound System
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
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.
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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Q9 Digital Color Doppler Ultrasound System
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
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.
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.
Video signal
Remote cable
cable
Power cord
Fig.3-3a
2) Connect the remote cable to remote port on the rear panel of ultrasound system. See picture in Fig.3-3b.
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Q9 Digital Color Doppler Ultrasound System
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
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.
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Q9 Digital Color Doppler Ultrasound System
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.
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Q9 Digital Color Doppler Ultrasound System
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
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Q9 Digital Color Doppler Ultrasound System
“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.
See layout of the Control Panel and Alphanumeric Keyboard in the above figure.
The main function of each key is introduced as below.
Press the C-knob to turn on the Color Flow Map (CFM) mode if
the system’s current state is B;
Press this knob can turn on Color if the system’s current state is
duplex Doppler;
CFM mode
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.
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
PD (CPA) mode mode;
Press the CPA-key for second time to turn off PD and return to the
previous mode (either B-mode or duplex Doppler)
Press the PW-knob to turn on the duplex Doppler duplex mode if
the current mode is B;
PW mode
Rotate the knob to change the overall Doppler gain for PW mode,
when activate the spectral Doppler mode.
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Q9 Digital Color Doppler Ultrasound System
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Q9 Digital Color Doppler Ultrasound System
Press the key to browse images, edit or print the stored images,
Browse
etc.
REPORT Press this key to generate a report with all the measurements
Press the Body Mark-key in real time or cine mode to bring up the
Body Mark entire sets of available Body Mark icons associated with the
current application.
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.
COMMENT
Press COMMENT-key to enter Comment mode.
Press this key during annotation entry to confirm the annotation
and quit from Comment mode.
Press the ARROW-key and the mouse cursor will appear on the
ARROW
screen.
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Q9 Digital Color Doppler Ultrasound System
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
DIST
Velocity.
In M cine mode, press DIST-key for Distance measurement
DEPTH Press this paddle up/down to change the image depth of view.
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Q9 Digital Color Doppler Ultrasound System
In Color mode, use this paddle to change the CROI steer angle for
STEER linear probe; in Doppler mode, this paddle can be used to change
PW cursor steering directions for linear probe.
Use this paddle to change the setting of the Wall Filter in the color
WALL FILTER
or Doppler modes.
U/D (Up/Down
Reverse the 2D(B or Color) image orientation 180 degrees
Reversion)
In single image mode, use L/R-key to reverse the image between the
L/R (Left/Right
left/right orientations;
Reversion)
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.
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Q9 Digital Color Doppler Ultrasound System
Chapter 4 Imaging
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.
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Q9 Digital Color Doppler Ultrasound System
Fig. 4-1
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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Q9 Digital Color Doppler Ultrasound System
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.
image
paramet
er area
thumbnail
area of
saving
Operation
images
note area
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 SK1—SK5:SK1—SK5 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.
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Q9 Digital Color Doppler Ultrasound System
operation note area:The 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
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Q9 Digital Color Doppler Ultrasound System
Fig. 4-5
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.
In B mode, press key .System will and display the current image at the left side of the screen, Press
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Q9 Digital Color Doppler Ultrasound System
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:
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 :
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Q9 Digital Color Doppler Ultrasound System
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.
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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Q9 Digital Color Doppler Ultrasound System
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.
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Q9 Digital Color Doppler Ultrasound System
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.
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Q9 Digital Color Doppler Ultrasound System
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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Q9 Digital Color Doppler Ultrasound System
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
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Q9 Digital Color Doppler Ultrasound System
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.
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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Q9 Digital Color Doppler Ultrasound System
Doppler Sample Volume Gate Position and Size (Trackball and SET)
Move the sample volume on the B-mode’s Doppler cursor. The gate is positioned over a specific position within
the vessel.
To move Doppler cursor position, turn the trackball left or right until positioned over the vessel.
To move sample volume gate position, move the trackball up or down until positioned inside the 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.
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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Q9 Digital Color Doppler Ultrasound System
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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Q9 Digital Color Doppler Ultrasound System
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Q9 Digital Color Doppler Ultrasound System
function for the first line; rotate shortcut can adjust parameters for next line.
3. Use other keys
Shortcut adjustment:
Shortcut
Menu Menu function Adjustable range of menu
(Action)
SK1
frequency Adjust frequency of the probe. Relate to current probe.
(press)
Adjust the image dynamic range,
SK1 dynamic
increase or decrease, System dynamic multi-step adjustable
(rotate) range
range and contrast resolution.
SK2 Focus 1~4 adjustable, relate to the probe type and
Changes focus numbers.
(press) Numbers depth.
SK2 Focus Changes focus position.
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Q9 Digital Color Doppler Ultrasound System
(rotate) position
SK3 Compound
Open compound imaging On, Off
(press) imaging
SK3
i-Image Open optimizing image multi-step adjustable
(rotate)
SK4 It can be on or off while COMPOUND is
SRA Open SRA
(press) off.
0~7 grade adjustable,clockwise for
SK4 Increase/decrease the contrast
Persistence increasing, anticlockwise for decreasing.
(rotate) resolution of the image
Adjust range: 1.
SK5
Density Change the image density High and Low adjustable
(press)
Adjust range: 0-255,clockwise for
SK5
Noise reject Adjust the image noise suppression increasing, anticlockwise for decreasing.
(rotate)
Adjust range: 1.
Other adjustments:
1 Depth(DEPTH 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.
Note:Change focus numbers will affect the frame rate. Frame rate will be slow if focus numbers are
increased.
4 Gain(B knob)
Adjust gain of B mode could enhance or reduce quantities of echo information in images. Adjust the main
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Q9 Digital Color Doppler Ultrasound System
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.
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Q9 Digital Color Doppler Ultrasound System
Blood Effection Choose different blood effection Smooth, HighRes
Shortcut Adjustment:
Shortcut
Menu Menu Function Menu Item adjustable Rang
(action)
SK1 Adjust the frequency of
Frequency Refer to current probe
(press) probe
Adjust angle of sampling box
SK1
Steer of blood flow under the linear Adjust range from -20 to 20
(rotate)
probe
SK2
Wall Filter Change of Wall filtering 0~3 adjustable
(press)
SK2
Color Map Change of Color Map Adjust option:User, Type:1- 9
(rotate)
SK3
Flow Change sensitivity of blood High, Middle and Low for option
(press)
SK3 The maximum PRF depends on the probe and the
PRF Adjust PRF value
(rotate) position of sampling box.
SK4
Invert Realize invert of blood flow Turn on or Turn of the invert
(press)
SK4
Persistence Improve the current color 0~7 grade adjustable. Adjust range: 1.
(rotate)
SK5
Density Change images density High and Low adjustable.
(press)
SK5 Change the baseline of color-
Baseline -3~3 adjustable.
(rotate) map
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.
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Q9 Digital Color Doppler Ultrasound System
4.3.21. Power Doppler(CPA) Mode imaging optimization
DPD Mode Exchange PD Mode and DPD Press it can exchange between PD Mode and
Mode DPD Mode
Shortcut Adjustment:
SK1(press) Frequency Adjust the probe launch Refer to current probe
frequency
SK1(rotate) Steer Adjust angle of sampling box Adjust range from -20 to 20,
of blood flow under the linear
probe
SK2(press) Wall Filter Change of Wall filtering 0~3 adjustable
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) Density Change images density High and Low adjustable
SK4(rotate) 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.
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Q9 Digital Color Doppler Ultrasound System
Shortcut adjustment:
Shortcut(action) Menu Menu Function Menu Item Adjustable Rang
SK1(press) Invert Spectrum invert Turn on or Turn off the invert function
SK3(rotate) PRF Adjust PRF value The maximum PRF value depends on
the probe and the position of sampling
gate.
SK4(rotate) Speed Adjust scanning speed 1,2,3 adjustable. adjust clockwise,
the numerical increase and adjust
anticlockwise, the numerical decrease.
Adjust range: 1
SK5(rotate) Baseline Adjust the baseline 0~6 adjustable.
position
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Q9 Digital Color Doppler Ultrasound System
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.
2、Sampling line
In PW mode, move the trackball left and right to adjust the position of sampling line
3、Sampling gate(Sampling volume)
Move the sample volume on the B-mode’s 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.
4、Gain
Rotate PW knob and adjust gain of PWD mode when PW light is on. Gain will be increased if rotate
clockwise;Gain will be decreased if rotate anti-clockwise. Adjustable range is from 0 to 255.
Shortcut adjustment:
Shortcut(action) Menu Menu Function Menu Item Adjustable Rang
SK1(press) Invert Spectrum invert Turn on or Turn off the invert function
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Q9 Digital Color Doppler Ultrasound System
SK3(rotate) PRF Adjust PRF value The maximum PRF value depends on
the probe and the position of sampling
gate.
SK4(rotate) Speed Adjust scanning speed 1,2,3 adjustable. Adjust
clockwise, the numerical increase and
adjust anticlockwise, the numerical
decrease. Adjust range: 1
SK5(rotate) Baseline Adjust the baseline 0~6 adjustable.
position
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.
2、Sampling 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
clockwise;Gain 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:
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Q9 Digital Color Doppler Ultrasound System
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.
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Q9 Digital Color Doppler Ultrasound System
Operation:
1 In comments status, moves the cursor to comments note which need to be changed then press
[ENTER] key.
Save single image:Press 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 image:Press arrow key in re-call status, then the mouse will appear on the screen. Move the
mouse to thumbnail images then click.
Save forward cine files:Press 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 files:Press 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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Q9 Digital Color Doppler Ultrasound System
Shortcut
SK1 SK2 SK3 SK4
Action
Adjust the
The frame of The frame of
Rotate playback
start position final position
speed of cine
Manual playback cine:Press 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.
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Q9 Digital Color Doppler Ultrasound System
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Q9 Digital Color Doppler Ultrasound System
Continue/Edit Exam:continue 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 Study:create 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
Cancel:Exit.
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.
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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Q9 Digital Color Doppler Ultrasound System
Search: Can search the patient files after enter a search term. Search will be more accurate when input more conditions.
Information:View the selected patient information.
Backup:Click 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 to:Select the content and click, can send files to other medium.
Delete:can delete patient's files, images etc.
Select all:Select all the patients.
Patients view:Under this view, one patient with multiple inspection data will be listed in column and also you can
check each exam file in details.
Study view:This view can list exam types one by one. Different exam type of one patient will not be listed in one
column.
New study:Create a new patient and recall into the patient information interface.
Continue/Edit Exam:Continue 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”.
Review:Select patient and click it to enter into images browse.
Cancel:Click “Cancel” to exit.
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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Q9 Digital Color Doppler Ultrasound System
After transmit into the target computer, open the shared folder, you can see the pictures you sent.
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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Q9 Digital Color Doppler Ultrasound System
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Q9 Digital Color Doppler Ultrasound System
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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Q9 Digital Color Doppler Ultrasound System
key to enter into review interface. Select the images need to be sent, click icon to print.
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Q9 Digital Color Doppler Ultrasound System
5. DICOM Worklist
DICOM Worklist parameters setting.
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Q9 Digital Color Doppler Ultrasound System
72
Q9 Digital Color Doppler Ultrasound System
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Q9 Digital Color Doppler Ultrasound System
CAUTION: Please select the most appropriate ultrasound images, measurement tools and measurement
methods for measurements according to your diagnosis needs. The final measurement results must be determined
and verified by a physician. Measurement accuracies are affected by many non-technical factors, for example
operator’s experience, patient’s status. Please do not only use the ultrasound measurement results as the sole basis
for diagnosis, please always use other clinical information to do integrated diagnostics.
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
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 【ENTER】key 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 the【ENTER】to 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.
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.
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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Q9 Digital Color Doppler Ultrasound System
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.
Area—trace
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.
Area—ellipse
1) In B mode, press the TRACE-key to bring up the trace start cursor plus sign (“+”).
2) Rotate SK2,choose 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.
6) To get the multiple data, repeat the same steps to create other distance pairs.
7) Press the Trace-key or EXIT-key to exit.
Area ratio
1) In B mode, press the TRACE-key to bring up the trace start cursor plus sign (“+”).
2) Rotate SK2,choose %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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Volume—1 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 measurement,the default measurement method is 1 straight line.
Volume—1 ellipse
1) In B mode, press the distance-key or trace-key to enter the measurement mode.
2) Press SK3-key to enter volume measurement,the default measurement method is 1 straight line.
3) Rotate SK3-key,choose 1 ellipse.
Volume—2 ellipse
1) In B Cine mode, press the distance-key or trace-key to enter the measurement mode.
2) Press SK3-key to enter volume measurement,the default measurement method is 1 straight line.
3) Rotate SK3-key,choose 2 ellipse.
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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.
Manual envelope
1) In PW Cine mode, press the Trace-key to enter automatic envelope measurement.
2) Rotate SK2,choose “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.
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 SK1,choose 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.
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.
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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.
5) To get the multiple data, repeat the same steps to create other distance pairs.
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
5) To get the multiple data, repeat the same steps to create other distance pairs.
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) To get the multiple data, repeat the same steps to create other distance pairs.
5) Press Calc-key or Exit key to exit.
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 A ×Axis B × axis B×3.1415926/6
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6. Volume(2distance)
Through 2 distance measurement, calculate the volume object.
Volume =distance1×distance2×distance2×3.1415926/6 (distance1>distance2)
Volume =distance2×distance1×distance1×3.1415926/6 (distance2>distance1)
7. Volume(3 distance)
Through 3 distance measurement, calculate the volume of object
Volume=distance1×distance2×distance3×3.1415926/6
8. Volume(1distance1ellipse)
Through 1distance measurement and 1 ellipse measurement, calculate the volume of object.
Volume=distance ×axis A × axis B×3.1415926/6
9. Volume(2 ellipse)
Through 2 ellipse measurement, calculate the volume of the object.
Volume=d1×d2×d4×3.1415926/6
d1 and d2 are axis of ellipse1;d3 and d4 are axis of ellipse 2: ∣d2-d3∣≤∣d1-d4∣,d2>d3
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 α and β will be displayed on the left side
of the screen. α is the angle between line d1 and line d2.β is the angle between line D1 and D3.
5) Press Calc-key or Exit key to exit.
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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=πErrore. L'origine riferimento non è stata trovata.i2
ESV=πErrore. L'origine riferimento non è stata trovata.i2
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
EDV(A4C) End-diastolic volume (A4C)[ml] Measurement (trace)
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.
Calculation formula for volume
(1)EDV=πErrore. L'origine riferimento non è stata trovata.(r2i r4i)
(2)ESV=πErrore. L'origine riferimento non è stata trovata.(r2i r4i)
r2i:Radius of i-th ellipse(2CH)
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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=πErrore. L'origine riferimento non è stata trovata.2i2
(4) ESV=πErrore. L'origine riferimento non è stata trovata.2i2
ri: Radius of the i-th circle(2CH)
LVLd: Left ventricular long-axis length at end diastole
LVLs: Left ventricular long-axis length at end diastole
(5) EDV=πErrore. L'origine riferimento non è stata trovata.4i2
(6) ESV=πErrore. L'origine riferimento non è stata trovata.4i2
ri: Radius of the i-th circle(4CH)
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
EDV(A2C) End-diastolic volume (A2C )[ml] Measurement (trace)
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.
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(Distance)".
EDV=
ESV=
<<Items to be measured>>
<<Items to be calculated>>
Calc. item name Description [Unit] Calc. formula
EDV End-diastolic left ventricular volume Refer to << Calculation formula for
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[mL] volume>>
ESV End-systolic left ventricular volume Refer to << Calculation formula for
[mL] volume>>
SV Stroke volume [mL] SV=EDV – ESV
CO Cardiac output [L/min] CO=SV x HR /1000
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<<Item to be measured>>
Meas. item Description Meas. method
name
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 Description [Unit] Calc. formula
name
EDV End-diastolic left ventricular volume EDV= LVIDd* LVIDd* LVIDd
[mL]
ESV End-systolic left ventricular volume ESV= LVIDs* LVIDs* LVIDs
[mL]
SV Stroke volume [mL] SV=EDV – ESV
CO Cardiac output [L/min] CO=SV * HR /1000
EF Ejection fraction [no unit] EF=SV/EDV
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FS Fractional shortening FS = (LVIDd -LVIDs)/LVIDd
8. AO/LV
<<Item to be measured>>
Meas. item Description Meas. method
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)".
<<Item to be calculated>>
Calc. item Description [Unit] Calc. formula
name
AO/LV AO/LVIDd AO/LVIDd
9. LVOT
<<Item to be measured>>
Meas. item Description Meas. method
name
LA Diam left ventricular outflow tract diameter Refer to "Distance
Measurement
(Distance)"
<<Item to be calculated>>
Calc. item Description [Unit] Calc. formula
name
Area left ventricular outflow tract area Refer to "area"
10. MV
<<Item to be measured>>
Meas. item Description Meas. method
name
MV Diam Mitral valve diameter Refer to "Distance
Measurement
(Distance)"
MVArea Mitral valve area Refer to "area
Measurement
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11. AV
<<Item to be measured>>
Meas. item Description Meas. method
name
AV Diam Tricuspid valve diameter Refer to "Distance
Measurement
(Distance)"
AVArea Tricuspid valve area Refer to "area
Measurement
Meas. item
mark unit Meas. method
name
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Note:SPSA must be input by manual in patient
interface when you select the urology exam type
Refer to "Distance Measurement (Distance)
Length cm
Refer to "Distance Measurement (Distance)
Left_Kidney Width cm
Refer to "Distance Measurement (Distance)
Height cm
V = (π/6) * Length* Width* Height
VOL ml
Vessel Dis
Vessel Dis cm Refer to "Distance Measurement (Distance)
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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: α is the angle between the D1 and D2(acute angle). Β is the angle between D1 and D3(acute angle)
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5.3.1.6 Vascular Measurement in B mode
Distal CCA The same as above The same as above The same as above
(Rt)/(Lt)
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Prox ICA The same as above The same as above The same as above
(Rt)/(Lt)
Mid ICA The same as above The same as above The same as above
(Rt)/(Lt)
Distal ICA The same as above The same as above The same as above
(Rt)/(Lt)
ECA(Rt)/ The same as above The same as above The same as above
(Lt)
Vertebral A The same as above The same as above The same as above
(Rt)/(Lt)
INT IIL(Rt) The same as above The same as above The same as above
/(Lt)
EXT IL(Rt) The same as above The same as above The same as above
/(Lt)
ILIAC(Rt)/ The same as above The same as above The same as above
(Lt)
CFA ( Rt ) / The same as above The same as above The same as above
(Lt)
ProFun(Rt)/ The same as above The same as above The same as above
(Lt)
LTCIR(Rt)/ The same as above The same as above The same as above
(Lt)
SFA ( Rt ) / The same as above The same as above The same as above
(Lt)
Pop A (Rt)/ The same as above The same as above The same as above
(Lt)
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ATA(Rt)/ The same as above The same as above The same as above
(Lt)
PTA(Rt)/ The same as above The same as above The same as above
(Lt)
PERON(Rt) The same as above The same as above The same as above
/(Lt)
DRPED(Rt) The same as above The same as above The same as above
/(Lt)
Meas. item name Mark Unit Meas. Method and calc. formular
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Right_OV_Volume Right_OV_L cm Refer to "Distance Measurement (Distance)
Right_OV_W cm Refer to "Distance Measurement (Distance)
Right_OV_H cm Refer to "Distance Measurement (Distance)
Right_OV_Volume ml PV = (π/6) * L* W* H
Left_FO_D Length cm Refer to "Distance Measurement (Distance)
Width cm Refer to "Distance Measurement (Distance)
RightFO_D Length cm Refer to "Distance Measurement (Distance)
Width cm Refer to "Distance Measurement (Distance)
Uterine Artery A Out cm
2 Refer to “Refer to Area(Ellipse)”
A In Refer to “Refer to Area(Ellipse)”
cm 2
STA% StA%= (A Out- A In)/ A Out *100%
%
D Out Refer to "Distance Measurement (Distance)
cm
D In Refer to "Distance Measurement (Distance)
cm
STD% StD%= (D Out- D In)/ D Out *100%
%
Vessel Area Refer to “Refer to Area(Ellipse)”
cm 2
Vessel Dis Refer to "Distance Measurement (Distance)
cm
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5.3.1.8 OB Measurement in B mode
Meas. item name Mark Unit Meas. Method and calc. formular
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GA week/day (Distance)”
EDD mm/dd/yyyy
EFW
OFD OFD cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
HC(ellipse) HC cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
APD APD cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
TAD TAD cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
AC(ellipse) AC cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
EFW g
FTA FTA cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
FL FL cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
SL SL cm Refer to "Distance Measurement
(Distance)”
APTD APTD cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
TTD TTD cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
ThC ThC cm Refer to "Distance Measurement
(Distance)”
Humerus Humerus cm Refer to "Distance Measurement
GA week/day (Distance)”
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EDD mm/dd/yyyy
ULNA ULNA cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
Tibian Tibian cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
RAD RAD cm Refer to "Distance Measurement
(Distance)”
FIB FIB cm Refer to "Distance Measurement
(Distance)”
CLAV CLAV cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
CER CER cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
CM CM cm Refer to "Distance Measurement
(Distance)”
NF NF cm Refer to "Distance Measurement
(Distance)”
OOD OOD cm Refer to "Distance Measurement
GA week/day (Distance)”
EDD mm/dd/yyyy
IOD IOD cm Refer to "Distance Measurement
(Distance)”
NB NB cm Refer to "Distance Measurement
(Distance)”
Lvent Lvent cm Refer to "Distance Measurement
GA (Distance)”
EDD
HW HW cm Refer to "Distance Measurement
(Distance)”
LtKid LtKid cm Refer to "Distance Measurement
(Distance)”
RtKid RtKid cm Refer to "Distance Measurement
(Distance)”
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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 cm Refer to "Distance Measurement
AF2 cm (Distance)”
AF3 cm Refer to "Distance Measurement
AF4 cm (Distance)”
AFI cm Refer to "Distance Measurement
(Distance)”
Refer to "Distance Measurement
(Distance)”
AFI=AF1+AF2+AF3+AF4
FBP AF cm Refer to "Distance Measurement
Result Scores (Distance)”
Give result according to AF
Meas. item name Mark Unit Meas. Method and calc. formular
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Subclavian A(Lt/Rt) A Out cm 2 Refer to "Area Measurement (Ellipse)”
A In Refer to "Area Measurement (Ellipse)”
cm 2
StA% StA %=(A Out-A In)/ A Out*100%
%
D Out Refer to "Distance Measurement (Distance)”
cm
D In Refer to "Distance Measurement (Distance)”
cm
StD% StD %=(D Out-D In)/ D Out*100%
%
Vessel Area Refer to "Area Measurement (Ellipse)”
cm 2
Vessel Dis Refer to "Distance Measurement (Distance)”
cm
Prox CCA(Lt/Rt) The same as The same The same as above
above as above
Mid CCA(Lt/Rt) The same as The same The same as above
above as above
Distal CCA(Lt/Rt) The same as The same The same as above
above as above
Bulb(Lt/Rt) The same as The same The same as above
above as above
Prox ICA(Lt/Rt) The same as The same The same as above
above as above
Mid ICA(Lt/Rt) The same as The same The same as above
above as above
Distal ICA(Lt/Rt) The same as The same The same as above
above as above
ECA(Lt/Rt) The same as The same The same as above
above as above
Vertebral(Lt/Rt) The same as The same The same as above
above as above
General Measurement The same as The same The same as above
above as above
Flow Volume Vessel Dis cm Refer to "Distance Measurement (Distance)”
Vessel Area cm 2 Refer to "Area Measurement (Ellipse)”
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5.3.1.10 Abdomen Measurement in B mode
Meas. item name Mark Unit Meas. Method and calc. formular
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Volume ml Volume = (π/6) * Length* Width* Height
Renal Vol.(Rt/Lt) Length cm Refer to "Distance Measurement (Distance)”
Height cm Refer to "Distance Measurement (Distance)”
Width cm Refer to "Distance Measurement (Distance)”
Lliac(Rt/Lt) Height cm Refer to "Distance Measurement (Distance)”
Width cm Refer to "Distance Measurement (Distance)”
A Out cm
2 Refer to "Area Measurement (Trace)”
A In Refer to "Area Measurement (Trace)”
cm 2
StA% StA%=(A Out-A In)/ A Out*100%
%
D Out Refer to "Distance Measurement (Distance)”
cm
D In Refer to "Distance Measurement (Distance)”
cm
StD% StD%=(D Out-D In)/ D Out*100%
%
Vessel Area Refer to "Area Measurement (Trace)”
cm 2
Vessel Dis Refer to "Distance Measurement (Distance)”
cm
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
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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.
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
<<Items to be measured>>
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Meas. item name Description [Unit] Meas. Method
IVSd lnterventricular septal thickness at Refer to distance measurement
end diastole [mm] (Distance)in B mode
LVIDd Left ventricular short-axis Refer to distance
diameter at end diastole [mm] measurement(distance) in B mode
LVIDs Left ventricular short-axis Refer to distance measurement
diameter at end systole [mm] (Distance) in B mode
LVPWd Left ventricular posterior wall Refer to distance measurement
thickness at end diastole [mm] (Distance) in B mode
<<Items to be calculated>>
5. LVSHORT
<<Items to be measured>>
<<Items to be calculated>>
6. AV
<<Items to be measured>>
<<Items to be calculated>>
7. AVSHORT
<<Items to be measured>>
<<Items to be calculated>>
AVO AVO[mm]
8. MV
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<<Items to be measured>>
<<Items to be calculated>>
9. MV Expert
<<Items to be measured>>
<<Items to be calculated>>
10. AV (EXPERT)
<<Items to be measured>>
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ET Ejection time[ms] M Time
RVOTD Diameter of right ventricular M distance
outlet[mm]
11. AO/LV
<<Items to be measured>>
<<Items to be calculated>>
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
refer to” M Time "
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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. A cursor”+” 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.
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. A cursor”|” will appear on the screen.
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3) Move the cursor by rotating the trackball to the start point of the one cycle and press Enter-key to fix it.
A second 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.
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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 .A cursor “+” 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 .A cursor “+”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
<<Items to be measured>>
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5.3.3.2 Cardiology Measurement in PW mode
1. MV
Measurement of Mitral valve function is performed in frozen Doppler spectral trace.
Note:
[MV Diam] can only be performed in 2-D mode.
<<Measurement points>>
1) Measure [E Vel] and [A Vel]. Measure [PHT]. Measure [E-Dur], [A-Dur], and [IR] Measure [HR].
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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 Refer to "Velocity Measurement'.
velocity [cm/s]
LVOT PG PW-mode LV out tract Refer to "Velocity Measurement'.
pressure gradient [mmHg]
LVOT V General
Meas. Item name Description [Unit] Meas. method
AoV VM
Meas. Item name Description [Unit] Meas. method
AoV MPG Aortic valve mean pressure Refer to “Full trace”
gradient [mmHg]
AoV PPG Aortic valve maximum Refer to “Full trace”
pressure gradient [mmHg]
LVOT Diam Left ventricular outflow tract Refer to “Distance Measurement in B
diameter [mm] mode”.
HR Heart rate [bpm] Refer to "Heart Rate Measurement
(HR)".
SV Stroke volume [mL] 0.785 x (LVOT Diam)2 * abs|VTI |
CO Cardiac output [L/min] SV x HR / 1000
AV Area AoV area [cm2] SV/AoV VTI / 100
Note:
[LVOT Diam] can only be performed in 2D mode
<<Measurement points>>
.
2) Measure [LVOT Diam]
3. TV
Measurement of tricuspid valve function is performed by using Doppler images.
<<Measurement items>>
TV VM Tricuspid valve mean velocity [cm/s] Refer to " Manual Trace Measurement "..
<<Measurement points>>
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 Max PG Maximum pressure gradient Refer to "Velocity Measurement”
[mmHg]
PV Diam Pulmonary artery diameter Refer to "Distance Measurement in B
[mm] 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)”
Note:
[PV Diam] can only be performed in 2D mode
<<Calculation items>>
<<Measurement points>>
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The measurement method and calculation items are the same as general measurement in PW mode
The measurement method and calculation items are the same as general measurement in PW mode.
The measurement method and calculation items are the same as general measurement in PW mode.
The measurement method and calculation items are the same as “manual trace”
The measurement method and calculation items are the same as “manual trace”
The measurement method and calculation items are the same as GYN measurement in PW mode.
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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-key,the 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.
Report Interface:
Choose the image:Click the image can add the image to the image area in the report, and click the image in the
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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.
Graph : Under OB report you can press this icon to enter in to see the fetal production graph.
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Chapter 6 Preset
6.1. Recall Preset
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Press key to enter into system setting interface. Select preset page. Add or delete the current preset.
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Hospital
hospital;Department; Input hospital name, department name
Information
Set Date Time Set Date and time (need password)
Date-Time
Set Regional Set Time Zone, Data Format, Time Format
Chinese;English;
French; Spanish;
Language Switch language interface
Russian; Polish;
Portuguese
Always show TGC
Image Option Select it ,it will always show TGC Curve .
Curve or not
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,
Freeze/UnFreeze;Cine
Save;Still Save
Print-key Video printing; Set the print-key function
PC print
Trackball Sensitivity(1~20) Set the sensitivity of the trackball option.
Option
PC print Picture and info or Only Please refer to 3.6.3
selection Picture
Paper Size
Video Image Only(640*480) Please refer to 3.6.1
Print Option Standard(800*600)
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7.2 Measurement
General Settings: Click the General page, and you can do some general settings of measurement items
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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:
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
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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:
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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.
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Select “Share this folder”, and click “Permissions” to modify user permissions.
Select “Full Control”, “Change”, “Read” for “Allow”, click “OK” to complete modification.
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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
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.
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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
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Click “Yes”
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Click “NEXT”
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Click “Finish”.
Display Settings: The settings include display device, display Settings, color correction, short Keys etc..
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Color Correction:In 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.
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Chapter 8 Probes
Cable
Stress Relief
Handle
Binding line
Transducer
Scan head (Lens)
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.
NOTE:
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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.
CAUTION:
These transducers are not designed to withstand heat sterilization methods. Exposure to
temperatures in excess of 60 º 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.
Mechanical hazard:
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A defective 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.
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 FDA’s March
29, 1991 Medical Alert on latex products.
DO NOT use an expired probe sheath. Before using a sheath, verify if it has expired.
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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.
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
when cleaning the lens face.
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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.
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.
Avoid mechanical shock or impact to the transducer and do not apply excessive bending or pulling force to the
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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 60°C. Under no circumstances should the transducer be subjected to heat
sterilization method. Exposure to temperatures above 60º 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 USA is 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
Planned maintenance
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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.
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.
Guidelines for Cleaning and Preparing Endocavitary Ultrasound Transducers Between Patients From AIUM
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
high-level disinfection of the probe between each use and use a probe cover or condom as an aid in keeping the
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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:
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.
152
Q9 Digital Color Doppler Ultrasound System
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.
Rooks VJ, Yancey MK, Elg SA, Brueske L. Comparison of probe sheaths for endovaginal sonography.
153
Q9 Digital Color Doppler Ultrasound System
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).
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.
CAUTION:
Some patients may be allergic to natural rubber or medical device with rubber contains. FDA suggests that
the user to identify these patients and be prepared to treat allergic reactions promptly before scanning.
154
Q9 Digital Color Doppler Ultrasound System
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 patient’s body, its acoustic output level should be decreased
to avoid any harmful interference with other equipment.
Operation Procedure:
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:
Please remove the cover (if any) before cleaning the probe.(The cover like condom is one time
155
Q9 Digital Color Doppler Ultrasound System
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
manufacturer’s 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 manufacturer’s recommended time.
Following all precautions for storage, use and disposal, prepare the germicide solution according to the
manufacturer’s instructions.
After removing from the germicide, rinse the probe according to the germicide manufacturer’s rinsing
instructions.
Flush all visible germicide residues from the probe and allow to air dry.
156
Q9 Digital Color Doppler Ultrasound System
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.
proper maintenance procedures. Contact the local CHISON’s Authorized Service Representative for parts or
To avoid electric shock hazard, do not remove panels or covers from console. This servicing must be performed by
If any defect is observed or malfunctions occur, do not operate the equipment but inform CHISON’s authorized
157
Q9 Digital Color Doppler Ultrasound System
service engineer for information.
Weekly Maintenance
The system requires weekly care and maintenance to function safely and properly. Clean the following:
LCD monitor
Footswitch
Printer
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.
NOTE:
When cleaning the screen, make sure not to scratch the LCD.
158
Q9 Digital Color Doppler Ultrasound System
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.
periodically. If there is any abnormal phenomenon with the machine, please contact our authorized agent in
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
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
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.
159
Q9 Digital Color Doppler Ultrasound System
Symptom Solution
The system can’t 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 Switch off the system, and check probe connection.
monitor has signal but no
ultrasound image
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 doesn’t 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 doesn’t 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 1) Adjust CFM or PW gain value properly;
noise 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 Adjust the power supply to normal voltage or use a voltage stabilizer
image area
The date and time on the screen is Press Setup-key to display General Setting screen, and correct time and date.
not correct
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 can’t change the setting at system interface, please check whether
the video printer is turned on and connected well with the main unit.
4)Please make sure the switch on the rear panel of printer is “on” status.
160
Q9 Digital Color Doppler Ultrasound System
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 CHISON’s authorized service engineer could
replace the defective parts. Any assembly, disassembly, handling, repair, or replacement by any
other people may have adverse impact on the safety and effectiveness of the systems and probes,
and thus will reduce the life time of the system and probes, and such systems and probes will not be
covered by CHISON warranty after the above improper handling. Standard maintenance must be
performed by CHISON’s authorized service engineer during the life time of the product.
and safety of system and probes maybe greatly affected, so it’s NOT
suggested to continue using the system and probes even the system and
probes seem work properly. But if user still wants to continue using the
system and probes, user should first contact CHISON service center at
CHISON headquarter to arrange the necessary safety check and calibration
by CHISON’s authorized service engineer. If CHISON headquarter service
center provides the calibration certificate for the related system or probe, then
user could continue use the system or probes according to the calibration
certificate. However, if CHISON headquarter service center concludes that
the system or probe is no longer complied to the safety and effectiveness
standard, then user should immediately stop using the system or probe. User
understands that such check and calibration cost will be born by the user.
Systems and probes keep on using after the life time may also be difficult to
repair and maintain, so it’s suggested to renew the product after the life time.
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
161
Q9 Digital Color Doppler Ultrasound System
Manufacturers Association, Rosslyn, VA; 2004a.
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
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
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
9) Medical Electrical Equipment standard IEC 60601-1, IEC60601-1-1, IEC60601-1-2, IEC 60601-2-37, IEC
60601-2-4
162
Q9 Digital Color Doppler Ultrasound System
Appendix A The Information of CE Representative
163
Q9 Digital Color Doppler Ultrasound System
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.
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,
164
Q9 Digital Color Doppler Ultrasound System
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 “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
Note:
After recovering the system successfully, users need to set "display Settings" manually to ensure video
printer work properly
165
Q9 Digital Color Doppler Ultrasound System
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.
166
Q9 Digital Color Doppler Ultrasound System
167
Q9 Digital Color Doppler Ultrasound System
Appendix C MAXIMUM ACOUSTIC OUTPUT REPORT
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm >1cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 4.89
deq(Zb) cm
fawf MHz 3.24 3.58
Dim X cm 3.52
of
Aaprt Y cm 1.1
td µs 0.78
prr Hz 235
Other
Informatio pr at max.Ipi MPa 2.39
n
deq at max.Ipi cm
Ipa.a at max.MI W/cm2 71.45
Operating Focus position cm 6 2
Control
Conditions A Power % 100 100
168
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 49.6
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 3.34
deq(Zb) cm
Dim of X cm 1.71
Aaprt Y cm 1.1
td µs 1.27
prr Hz 1194
Other
pr at max.Ipi MPa 1.52
Information
deq at max.Ipi cm
169
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 21.32 32
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 4.45
Parameter
Z at max.Ipi.a cm 3.6
deq(Zb) cm 1.99
td µs 0.42
prr Hz 164
Other
pr at max.Ipi MPa 2.33
Information
deq at max.Ipi cm 1.95
170
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 40 36
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 4.97
Parameter
Z at max.Ipi.a cm 5.0
deq(Zb) cm 0.23
td µs 1.23
prr Hz 4376
Other
pr at max.Ipi MPa 1.62
Information
deq at max.Ipi cm 0.24
171
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 4
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 4.88
deq(Zb) cm
Dim of X cm 3.52
Aaprt Y cm 1.1
td µs 0.78
prr Hz 2376
Other
pr at max.Ipi MPa 2.39
Information
deq at max.Ipi cm
172
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 49.6
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 3.36
deq(Zb) Cm
Dim of X cm 1.71
Aaprt Y cm 1.1
td µs 1.27
prr Hz 1194
Other
pr at max.Ipi MPa 1.52
Information
deq at max.Ipi cm
173
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 21.32 32.54
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 4.23
Parameter
Z at max.Ipi.a cm 3.6
deq(Zb) cm 1.99
td µs 0.42
prr Hz 164
Other
pr at max.Ipi MPa 2.33
Information
deq at max.Ipi Cm 1.95
174
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 40 36
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 4.54
Parameter
Z at max.Ipi.a cm 5.0
deq(Zb) cm 0.23
td µs 1.23
prr Hz 4376
Other
pr at max.Ipi MPa 1.62
Information
deq at max.Ipi cm 0.24
175
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 2
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm
Dim of X cm 0.4229
Aaprt Y cm 0.1475
td µs 0.195
prr Hz 6024
Other
pr at max.Ipi MPa 1.664
Information
deq at max.Ipi cm
176
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 48
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm
Dim of X cm 0.177
Aaprt Y cm 0.2549
td µs 0.196
prr Hz 12100
Other
pr at max.Ipi MPa 1.976
Information
deq at max.Ipi cm
177
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 16 16
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 2.25
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm 0.258
td µs 0.166
prr Hz 2336.4
Other
pr at max.Ipi MPa 1.981
Information
deq at max.Ipi cm 0.258
178
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 46 46
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 1.209
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm 0.484
td µs 0.471
prr Hz 7168
Other
pr at max.Ipi MPa 1.031
Information
deq at max.Ipi cm 0.484
179
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 4
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm
Dim of X cm 0.3479
Aaprt Y cm 0.4447
td µs 0.257
prr Hz 2614
Other
pr at max.Ipi MPa 5489
Information
deq at max.Ipi cm
180
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm >1cm2
P mW 14
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm
Dim of X cm 0.2895
Aaprt Y cm 0.2679
td µs 0.264
prr Hz 10400
Other
pr at max.Ipi MPa 2.061
Information
deq at max.Ipi cm
181
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm >1cm2
P mW 8 8
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 2
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm 0.177
td µs 0.297
prr Hz 2379
Other
pr at max.Ipi MPa 3.074
Information
deq at max.Ipi cm 0.99
182
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 72 102
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 2.05
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm 0.588
td µs 0.648
prr Hz 6098
Other
pr at max.Ipi MPa 1.856
Information
deq at max.Ipi cm 0.587
183
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 4
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm
Dim of X cm 0.4229
Aaprt Y cm 0.1475
td µs 0.145
prr Hz 6024
Other
pr at max.Ipi MPa 1.644
Information
deq at max.Ipi cm
184
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm >1cm2
P mW 48
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm
Dim of X cm 0.177
Aaprt Y cm 0.2549
td µs 0.146
prr Hz 12400
Other
pr at max.Ipi MPa 1.476
Information
deq at max.Ipi cm
185
Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm >1cm2
P mW 16 16
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 2.25
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm 0.258
td µs 0.146
prr Hz 2306.4
Other
pr at max.Ipi MPa 1.281
Information
deq at max.Ipi cm 0.258
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Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm >1cm2
P mW 46 46
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm 1.209
Parameter
Z at max.Ipi.a cm 2
deq(Zb) cm 0.484
td µs 0.471
prr Hz 6168
Other
pr at max.Ipi MPa 1.031
Information
deq at max.Ipi cm 0.484
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Q9 Digital Color Doppler Ultrasound System
TIS TIB
Non-
Non-scan
Index Label MI TIC
Scan Non-
Non-scan
Aaprt Aaprt
2 2
≤1cm2 >1cm2
P mW 2
Min of [Pa(Zs),
mW
Ita.a(Zs) ]
Zs cm
Associated Zbp cm
Acoustic Zb cm
Parameter
Z at max.Ipi.a cm 2.5
deq(Zb) cm
Dim of X cm 1
Aaprt Y cm 0.6439
td µs 0.578
prr Hz 3623.3
Other
pr at max.Ipi MPa 2.948
Information
deq at max.Ipi cm
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Q9 Digital Color Doppler Ultrasound System
According to IEC60601-2-37 and NEMA UD-3 2004, the display accuracy and acoustic measurement uncertainties are
summarized in the table below.
Measurement Uncertainty
Item
(Percentage, 95% Confidence Value
Center Frequency ±5%
Acoustic Power ±30%
Acoustic Intensity ±30%
Peak Rarefactional Pressure ±15%
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Q9 Digital Color Doppler Ultrasound System
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.
Ambient Maximum surface
Maximum surface
Transducer (℃
℃) temperature(℃
℃)
temperature(℃℃)
model Contacting human-tissue
Suspending in air
mimicking material
D3C60L 25 33±
±1 47±
±1
D7L40L 25 32±
±1 39±
±2
D6C12L 25 29±
±1 45±
±2
D6C15L 25 33±
±1 43±
±2
D3C20L 25 33±
±1 46±
±2
V4C40L 25 31±
±1 39±
±2
Note: Values following the “ ± ”mark indicate the expanded uncertainty with a confidence lever of
95%,t.975=4.30.
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Q9 Digital Color Doppler Ultrasound System
APPENDIX E GUIDANCE AND MANUFACTURER’S DECLARATION
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 Group 1 The Q9 uses RF energy only
CISPR 11 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 Class A The Q9 is suitable for use in
CISPR 11 all establishments, including
domestic stablishments and
Harmonic emissions Class A those directly connected to the
IEC 61000-3-2 public low-voltage power
Voltage fluctuations/ Complies supply network
flicker emissions that supplies buildings used for
IEC 61000-3-3 domestic purposes.
2. Guidance and manufacturer’s 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.
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Q9 Digital Color Doppler Ultrasound System
3 Guidance and manufacturer’s 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 IEC 60601 test IEC 60601 test Electromagnetic environment – guidance
Test level level
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications
IEC 61000-4-6 150 kHz to 80 3 V/m equipment should be used no closer to any
Radiated RF MHz part of the Q9, including cables, than the
IEC 61000-4-3 3 V/m recommended separation distance
80 MHz to 2,5 calculated from the equation applicable to
GHz 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.
194
Q9 Digital Color Doppler Ultrasound System
APPENDIX F MEASUREMENT RESULTS SUMMARY
195