7.19 MAN ECG preamplifier...................................................................................................7-14
Voluson
®
730 - Instruction Manual
4 - CONTENTS 105838 Rev. 3
General
1. General ..........................................................................................................................1-2
Voluson
105838 Rev. 3 1-1
®
730 - Instruction Manual
General
1. General
The Voluson® 730 is a professional Diagnostic Ultrasound System which transmits Ultrasound waves
into the body tissues and forms Images from the information contained within the received echoes.
The Voluson® 730 is an Active Diagnostic Medical Product belonging to Class IIa according to the
MDD 93/42/EWG regulation for use on human patients.
The Voluson® 730 is developed and produced by the company Kretztechnik.
For more Information please contact:
GE Medical Systems Kretztechnik GmbH & Co OHG
Tiefenbach 15 Telephone: +43-7682-3800-0
A-4871 Zipf Fax.: +43-7682-3800-47
Austria E-mail:
The VOLUSON® 730 scanner system has been designed for utmost safety for patient and user. Read
the following chapters thoroughly before you start working with the machine! The manufacturer
guarantees safety and reliability of the system only when all the following cautions and warnings are
observed.
INTENDED USE
Please note that the cautions and warnings described in this section have to be observed like Electrical
Installations, Important Instructions for Safety, Environmental conditions for operation etc.
Please see section 2.1 to 2.16
Also take care that the diagnostic possibilities of modes and the clinical applications of probes
(indications for use) are known, please review Description of the System
and technical description of the concerned Probe User’s manual.
For Technical Data
Respectively see chapter 22 and chapter 20of the Basic User Manual for Voluson
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN
WARNING:
CAUTION:
CAUTION
It might be possible that some probes are NOT available in some countries!!
CAUTION
: The manual refers to probes that can be connected to the device.
: Some features and options are not available in some countries!!
(chapter 3) resp. General
see: chapter 7 and Connections internal and external accessories see: chapter 6.
®
730.
describes precautions necessary to prevent risks of live.
describes precautions necessary to protect the equipment.
2.1 Important Instructions for Safety
WARNING ! This equipment must not be used in the presence of inflammable gases (e.g. anesthetic
gases) => explosion hazard!
WARNING !
WARNING !
WARNING !
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2-2 105838 Rev. 3
The system must only be connected to a fully intact mains socket with a grounded
guard wire via an appropriate mains cable. The ground wire must never be removed or
disconnected.
No covers or panels must be removed from the system (high-voltage risk). GE
Medical Systems-authorized personal must only perform Service and repairs.
Attempting do-it-yourself repairs invalidate warranty and are an infringement to
regulations and are inadmissible acc. to IEC 60601-1.
Under the condition of regular maintenance by the authorized service personal a
lifetime of the equipment of 10 years may be expected.
Only accessories explicitly recognized by the system manufacturer GE Medical
Systems Kretztechnik GmbH & Co.OHG may be used in connection with the system.
®
730 - Instruction Manual
Safety
WARNING !
WARNING !
The footswitch must not be used in operating rooms!
There have been reports of severe allergic reactions to
medical devices containing latex (natural rubber). Operators
are advised to identify latex-sensitive patients and be
prepared to treat allergic reactions promptly.
Refer to FDA Medical Alert MDA91-1
2.2 Electric installation
The system must be exclusively installed in medically used rooms. The equipment conforms with
regulations for electrical safety (EN60.601-1/1990 resp. ÖVE-MG/EN60.601-1/1991 and IEC 60601)
and safety class IIa according to the MDD 93/42/EWG regulation for use on humans patients. Probes
are rated Type BF. Local safety regulations may require an additional connection between the
potential equilibrium bolt and the building's grounding system.
CAUTION !
The minimum required house installation must have 16A.
Before switching on the first time, the local mains voltage and frequency are to be
checked against the values indicated on the VOLUSON® 730 nameplate on the rear
panel. Authorized personnel must only perform any change to the system.
2.3 Symbols used
Some symbols used with electrical medical equipment have been accepted as standard by IEC.
They serve for marking of connection, accessories, and as warnings.
Mains switch ON acc. to IEC 417 5007
Mains switch OFF acc. to IEC 417 5008
Standby switch of the System. Location see: System Configuration acc. to IEC 417 5009
ON switch of the isolation transformer for auxiliary devices acc. to IEC 417 5264
OFF switch of the isolation transformer for auxiliary devices acc. to IEC 417 5265
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Safety
CAUTION! Review user manual for proper operation!
(Improper use may cause damage.)
Insulated patient application part acc. to EN60 601-1(Type BF)
IPX1 Protection against dripping water.
IPX7 Protection against the effects of immersion.
Potential equilibrium connection (rear panel)
Dangerous electric voltage
Pull the mains plug before opening the unit!
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Safety
2.4 Remarks for safe Use
• Get acquainted with the transducers and the ultrasound system: read the user manual thoroughly!
• Follow these safety instructions as well as the clinically adopted precautions and measures for
hygiene.
• The manufacturer is not liable for damage caused by improper or inexpert use of the device!
• Any ultrasound transducers - irrespective of system and design - are sensitive to shock and shall
be treated with care. Pay attention to cracks which may allow conductive fluids to leak in.
• Authorized personnel shall only perform any type of repair. Never attempt to open a transducer or
transducer connector. This leads to a loss of guarantee!
• Avoid kinking, bending or twisting of probe cables and take care to guard them against
mechanical stress (e.g., wheels or heels).
• The probes must not be exposed to mechanical shock (e.g., by dropping).
Any damage caused in this manner invalidates warranty.
• Have the scanner system and the transducers regularly checked (for faulty cables, housing, etc.)
by authorized personnel!
• Damage to transducer or cable may lead to a safety hazard, therefore have them repaired
immediately!
• Before plugging in or unplugging a transducer, activate the "FREEZE" mode!
• A specialist acquainted with the handling and use of the system shall perform installation and first
switch-on and check-up of the system.
• The user must have read and understood the user manual.
The system must only be operated by trained and qualified personnel.
• For safety reasons, avoid handling fluids in the vicinity of the system. Fluids leaking into the disk
drive can damage the drive. Never remove the storage shelf above the probe connectors; it helps
to protect the unit from fluids.
• Do not put your hand under the control console when moving it: Danger of injuries!
• Trolley: never move the unit with blocked wheels, but block the wheels in the proximity of stairs
and ramps.
• Place the unit always on horizontal ground and block the front wheels: Danger of tipping over and
rolling away.
• In transporting the unit, raise the footrest: Danger of injuries!
• The user manual must always be with the scanner system. It is the user's duty to ensure this!
• Only probes conforming to type BF requirements may be used with the VOLUSON® 730.
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See the probe's label. In case of doubt ask authorized service personnel.
• The Voluson® 730 system has been tested for EMC and is compliance with
EN 55011:1991 group 1 class A (CISPR 11:1997 amendment 1:1999) and EN 60601-1-2:1993.
The Voluson® 730 system is approved for use in a residential district. It is expected that
the user has medical experience and is well informed with the user manual.
• Mains power quality should be that of a typical commercial and/or hospital environment.
If the user requires continued operation during power mains interruptions, it is recommended that
the system be powered from an uninterruptable power source (UPS).
There have been reports of severe allergic reactions to medical devices
containing latex (natural rubber). Operators are advised to identify latexsensitive patients and be prepared to treat allergic reactions promptly.
Refer to FDA Medical Alert MDA91-1.
2.5 Environmental Conditions for Operation
Temperature: 10°C to 40°C resp. 50°F to 104°F
Humidity: 30% to 80% RH, no condensation
Barometric pressure: 700 to 1060 hPa
CAUTION !
CAUTION !
Do not operate the system in the vicinity of a source of heat, of strong electric or
magnetic fields (close to a transformer), or near instruments generating highfrequency signals, such as HF surgery.
These can affect the ultrasound images adversely.
In the event the equipment has been brought from cold environment (stock room,
airfreight) into a warm room, allow several hours for temperature balance and
passing of condensation humidity before switching on the first time.
2.6 Instruction for Use
This equipment has been tested and found to comply with the limits for medical devices in IEC 606011-2:1994. These limits are designed to provide reasonable protection against harmful interference in a
typical medical installation.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipments.
- Connect the equipment to an outlet on a circuit different from that to which the other device(s) are
connected.
- Consult the manufacturer or field service technician for help.
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2.7 Biopsy Lines
To achieve best possible accuracy of the display of the needle way, the biopsy lines have to be
programmed for each transducer.
review: To program a Biopsy Line
WARNINGS !
• The biopsy lines must be programmed once by the service personnel or by the user.
The procedure must be repeated if probes and /or biopsy guides are exchanged.
• Before performing a biopsy, make sure that the displayed biopsy line coincides with the needle
track (check in a bowl filled with approx. 47°C warm water!).
• The needle used for this alignment verification must not be used for the actual procedure.
Always use a straight, new and sterile needle for each biopsy procedure.
(chapter 19.1) of the Basic User Manual for Voluson® 730.
2.8 ECG-preamplifier (MAN)
The ECG preamplifier type MAN is an option of the ultrasound scanner unit, used to obtain an ECG
signal to mark the systolic and end-diastolic moments in M mode and Doppler evaluations.
WARNINGS !
• The MAN is not intended for ECG diagnosis. It must not be used for an intra-operative application
of the heart.
• Monitor: Not for use as a cardiac monitor.
• Only the patient cable supplied by GE Medical Systems - Kretztechnik, and only recommended
electrodes must be used.
• Take care that neither bare parts of one of the three electrodes nor the patient comes into contact with
conductive parts (e.g., metal parts of the examination bed, trolley, or similar).
• If the use of a HF surgical unit with simultaneously connected ECG electrodes becomes necessary, a
large distance of ECG electrodes from the surgical field and a perfect position of the neutral
electrode of the HF surgical unit must be observed (avoiding burning risk).
• If the use of a defibrillator becomes necessary, there must be no ECG adhesive electrodes and no
conductive paste between the correct positions of the defibrillator plates (avoiding current bridge; the
signal input of the ECG preamplifier is defibrillator-safe).
For further details and information’s please review: MAN ECG preamplifier
User Manual for Voluson® 730.
(chapter 21) of the Basic
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2.9 Cleaning and Maintenance
Daily cleaning of the scanner, the probes and the probe holders from coupling gel, mineral oil etc. is
recommended, wet cloth and soap are allowed.
CAUTION !
Have the system checked and serviced in regular intervals (once per year) by authorized service
personnel. In case of total failure first check if mains voltage is present.
Mentioning any observations or failure symptoms to the service engineers is helpful.
Before cleaning the scanner switch it off. Do not use disinfection spray nor gas
disinfection. Electric parts must be protected from drip water. Keep the touchpanel
screen clean. Dust and parts on the frame can cause irregular function!
Check the mains cable, transducer cables, plugs and sockets regularly.
2.10 Safety Test
Scan time limits: Acc. to respective national regulations, and acc. to the manufacturer
recommendations for the medical-technical unit.
Range:
a) Visual inspection:
Housing, connection, operating elements, display facilities, labels, accessories, user manual.
b) Functional test:
Checking of functions (acc. to user manual), check also modular combinations and common
operability of system and accessories.
c) Electric test:
Checking of the electric safety of system combinations acc. to VDE 0751 or respective
national regulations.
For safety reasons, avoid handling fluids in the vicinity of the system.
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Safety
2.11 Manufacturer Responsibility
The manufacturer, assembler, importer or installer considers himself/herself responsible regarding
safety, reliability and performance of the instrument under the following conditions:
- when assembling the system, when performing add-ones, when new settings or modifications or
repairs were performed by personnel authorized by him/her,
- also that the local electric installation complies to the national regulations,
and that the equipment is only used according to the User Manual.
2.12 Service Documents
The Service Manual supplies block diagrams, lists of spare parts, descriptions, adjustment instructions
or similar information which help adequately qualified technical personnel in repairing those parts of
the instrument which have been defined repairable by the manufacturer.
2.13 Basic interaction between Ultrasound and Matter
2.13.1 Bioeffects
"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:
No confirmed biological effects on patients or instrument operators caused by exposure at intensities
typical of present diagnostic ultrasound instruments have ever been reported. Although they indicate
that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any, that
may be present."
Reference: Bioeffects considerations for the safety of Diagnostic Ultrasound - Journal of
Ultrasound in Medicine, Vol.7, Number 9 (supplement) - American Institute of
Ultrasound in Medicine, Bioeffects Committee.
Please note: Prudent use means that the ultrasound machine is to be used by the operator in
accordance with the ALARA principle, i.e. keep the power levels and the exposure
time AS LOW AS REASONABLY ACHIEVABLE.
An ultrasound bioeffect is any biological mechanism or process, which is produced, triggered or
catalyzed by exposure to ultrasound.
One can differentiate two known mechanisms for the development of bioeffects when humans are
exposed to ultrasound: the thermal effect of ultrasound and the cavitation.
With humans no harmful bioeffects due to exposure to diagnostic ultrasound have been noticed.
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The rise in tissue-temperature under the influence of ultrasound energy is called thermal effect.
The level of the temperature rise depends mainly on the following parameters: the irradiated quantity
of energy, the surface of exposure and the thermal characteristics of the tissue. Regarding the
thermodynamics, the AIUM-report comes to the following conclusions:
• When only the temperature criteria is considered, an exposure to diagnostic ultrasound, leading to
a rise in temperature of 1°C above the normal physiological value can be made without limitations
in clinical examinations.
• With fetal use a temperature rise in situ beyond 41°C is considered dangerous; the risk of harming
the fetus is increased with the duration of this temperature rise.
• For fetal use the following intensities are considered to be safe:
• SATA-intensity (in situ) below 200 mW/cm2 with beam widths of less than 11 wavelengths.
• SATA-intensity (in situ) below 300 mW/cm2 with beam widths of less than 8 wavelengths.
Note that the thermal model of the AIUM does not take into account the influence of tissue blood
circulation.
Cavitation concerns the reaction of gas- or vapor bubbles or gas- or vapor accumulations present in
tissue or liquids. Two types of cavitation - transient and stable - have been described and investigated
in in-vitro and animal tests (Flynn HG, Physics of Acoustic Cavitation in Liquids, in Physical
Acoustics: Principals and Methods, edited by Mason, WP, Academic Press, New York, 1964, Vol. I/B,
Chap. 9, pp. 57-172).
Transient cavitation means dilatation and quick collapsing of a bubble as a reaction to one or more
ultrasound pulse beams. This quick collapse can lead to locally limited (in micrometer range) high
temperatures and pressures.
Stable cavitation concerns the repeated oscillation of a bubble. This bubble oscillation can have effects
on neighboring cells, especially due to transverse action acting on its membrane and due to
disturbance of the contained cytoplasma. Amplitude and frequency of the bubble oscillation are
dependent on the bubble size at the beginning and resonance frequency characteristics as well as on
frequency and pressure of the impinging ultrasound. With tissue of mammals the scientists came to
contradictory results regarding the ability to produce cavitation. This is possibly due to differences in
the occurrence of cavitation germs (bubbles). Very little is known about the factors determining the
presence or absence of micro bubbles, their chemical consistence and visco-elastic characteristics. The
results of cavitation tests also depend on ambient pressure, on the acoustic energy and the pressure
level. With the output power used in diagnostic ultrasound no cavitation was observed in vivo.
The AIUM-report reaches the following conclusions regarding cavitation:
• Cavitation can occur with short pulses and produces potentially harmful biological effects.
• A peak pressure of 10 MPa (3300 W/cm2) can lead to cavitation with mammals.
With the limited data available it is not possible to specify threshold values for the pressure amplitude
at which - when using diagnostically relevant pulse lengths and pulse repetition frequencies cavitation occurs with mammals.
Some scientists observed that the peak rarefaction pressure (pr) of the transmitted disturbance is
related closer to occurrence of cavitation than to the overall measured peak pressure (due to
compression plus rarefaction). Other examinations showed that the peak rarefaction pressure of the
basic oscillation component of the disturbance could be among the three mentioned parameters the
most closely related to the cavitation.
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The following results are contained in the AIUM-report too:
• Other acting mechanisms - no other acting mechanisms for bioeffects are known, that are caused
by exposure to diagnostic ultrasound.
• Epidemiology - in more than 25 years of extensive clinical ultrasound application no harmful
effects due to exposure to diagnostic ultrasound have become known.
• Bioeffects in vivo with mammals - no significant bioeffects in vivo independently confirmed could
be determined under the following conditions:
• Unfocussed exposure with an SPTA-intensity of less than 100 mW/cm2 in an exposure period of
less than 500 seconds (measured in water).
• Focused exposure with an SPTA-intensity of less than 1 W/cm2 in an exposure period of less than
50 seconds (measured in water).
• Product from intensity (measured in water) and time of exposure less than 50 joule/cm2.
2.13.2 Intensities Measured in Water and recalculated In Situ
All intensity parameters are determined by measurement in water. As water does not absorb the
acoustic energy, these measurements in water represent the most unfavorable value. In biological
tissue however the acoustic intensity is absorbed. The "real" value in a given position depends on the
amount and type of tissue through which the ultrasound beam passes and on the ultrasound frequency.
The value in tissue (in situ) can be approximately determined with the following formula:
in situ = water [ e
Whereas: in situ = value in situ
water = value in water
e = 2.7183
d = attenuation coefficient
l = distance from skin surface to measuring depth (cm)
f = mean frequency of combination probe/system/operation
tissue
d (dB/cm/MHz)
brain
heart
kidney
liver
muscle
As the ultrasound generally crosses tissue layers of different thickness and different types on its way
through the body during an examination, it is very difficult to estimate the real intensity in situ.
For reports generally an impedance coefficient of 0.3 dB/cm/MHz is assumed. The value in situ that is
generally indicated in reports is calculated according to the following formula:
in situ (recalculated ) = water [e
-(0.69lf)
As this value must not be considered as the real intensity in situ, the term "recalculated" is used
hereunder.
-(0.23dlf)
mode (MHz)
0.53
0.66
0.79
0.43
0.55
]
]
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In some cases the max. Recalculated value and the max. Value in water do not occur under the same
operating conditions. Therefore the max. Values in water and recalculated max. Values mentioned in
reports may not be related according to the above mentioned formula.
For example: An array probe with multiple focusing, whose max. Intensity values in water are lying in
the deepest focal zone; for this zone, however, the smallest recalculating factor is valid. With the same
probe the highest recalculated intensity can be lying in one of the focal zones closest to the surface.
The FDA has laid down limits for the max. recalculated intensity values (see following section).
Therefore the recalculated intensities are brought to the highest possible value with the help of the
system controls when the output power is tested. Under all operating conditions the point of the max.
Recalculated intensity can be closer to the probe than the point of the max. Intensity in water; it will
never be further away from the transducer.
2.13.3 Derivation and Meaning of the thermal and mechanical Indices
Thermal Index (TI) is a quantity related to calculated or estimated temperature rise under certain
defined assumptions. The Thermal Index is the ratio of total acoustic power to the power required to
raise tissue temperature by 1°C under defined assumptions. In the calculation of all Thermal Indices in
the "Standard for real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment", of the AIUM and NEMA, the average ultrasonic attenuation is assumed to be
0.3 dB/cm-MHz along the beam axis in the body.
Soft Tissue Thermal Index (TIS) is the Thermal Index related to soft tissues.
Bone Thermal Index (TIB) is the thermal index for applications, such as fetal (second and third
trimester) or neonatal cephalic (through the fontanel), in which the ultrasound beam passes through
soft tissue and a focal region is the immediate vicinity of bone.
Cranial Bone Thermal Index (TIC) is the Thermal Index for applications, such as pediatric and adult
cranial applications, in which the ultrasound beam passes through bone near the beam entrance into
the body.
Mechanical Index (MI) formula is the spatial-peak value of the peak rare factional pressure, derated
by 0.3 dB/cm-MHz at each point along the beam axis, divided by the square root of the center
frequency. To make the MI unitless, the right-hand side of the equation below is multiplied by [(1
0.5
MHz)
Scanned mode (auto-scanning) is the electronic or mechanical steering of successive ultrasonic pulses
or series of pulses, through at least two dimensions.
Unscanned mode (nonautoscanning) is the emission of ultrasonic pulses in a single direction, where
scanning in more than one direction would require moving the transducer assembly manually.
/(1 Mpa)].
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Reference: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices
2.13.4 FDA-Limits for Acoustic Output and Bioeffects
The American Food and Drug Administration (FDA) has laid down maximum values in situ *
(recalculated) for different clinical applications, which are valid independent of the operation mode
(2D, M-Mode, Doppler). These values are not defined on the basis of the ultrasound bioeffects, but are
based on the output power of instruments, that were manufactured prior to the modification of FDARegulations 1976. The enclosed acoustic output tables contain the recalculated limits as laid down by
FDA and the values mentioned in the AIUM-report.
• Contains the recalculated limits as laid down by FDA and the values mentioned in the AIUMreport.
• No limits were laid down by the FDA for measurements in water.
2.13.5 Summary
1. Presently limits for the output power are laid down neither by the FDA, nor by AIUM-report of
the Bioeffects Committee. Thermal models in development in 1991 include the output power.
2. The AIUM report contains no specific conclusions regarding an I
3. The I
is a relevant parameter regarding bioeffects. The FDA limits and the values
SPTA
recommended by the AIUM concerning bioeffects are compatible. In some of the thermal model
in development in 1991 there is an I
SPTA
factor.
4. The AIUM report does not contain any specific conclusions regarding an I
limits. Presently (1991) the FDA considers to renounce to the I
MAX
power to be reported.
5. Presently the FDA considers a cavitation parameter the mechanical index MI which is based on
Pr. The limit for MI is 1.9.
6. The FDA considers I
I
are not based on bioeffects; they are rather based on the output power before the
SATA
as a relevant parameter regarding bioeffects. The FDA limits for the
SATA
regulation modification 1976.
7. No limits for the measurement in water were laid down.
8. In some cases the tissue can be exposed to sound and intensity values that are higher than those
given (recalculated) for in situ. In these cases the reported values in situ do not represent the worst
case of exposure. But this case occurs only if the tissue has an attenuation coefficient below 0.3
dB/cm/MHz, e.g. with a long way through liquids and a short way through tissue. In such cases an
output power of less than 100% is recommended; therefore the examiner should reduce the power
in order to reduce sound intensity impinging on the tissue.
within the FDA limits.
SPPA
within the FDA
MAX
as a parameter of the output
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2.13.6 Display Accuracy of the Indices
On the right side of the monitor display the thermal and mechanical indices are displayed.
While scanning, notice the index numbers you are using and which controls affect the readings.
Try to keep the index numbers as low as you can, while maintaining diagnostic information within the
image. This is particularly important when scanning the fetus. The display accuracy of the mechanical
index and all thermal indices is 0.1. Values below 0.4 are not displayed.
Reference:
"Standard for real-time Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment", AIUM/NEMA, Washington, DC, 1992.
2.13.7 Recommendation to use and for the Need for following the ALARA
Principle
The AIUM publication "Medical Ultrasound Safety", published 1994 by the AIUM says the following
about the ALARA principle:
The ALARA principle "stands for 'As Low As Reasonably Achievable'. Following the ALARA
principle means to keep the total ultrasound exposure as low as reasonably achievable, while
optimizing diagnostic information.
With the new ultrasound equipment, the output display lets us determine the exposure level in terms of
the potential for bioeffects...", and "Because the threshold of diagnostic ultrasound bioeffects is
undetermined, it becomes our responsibility to control the total exposure to the patient. Controlling the
total exposure depends on output level and exposure time. The output level required for an exam
depends on the patient and on the clinical need. Not all diagnostic exams can be performed at very low
levels. In fact, using too low levels may result in poor data and the need to repeat the examination.
Using too high a level may not increase the quality of the information, but it will expose the patient to
unneeded ultrasound energy."
"Ultimately, the exposure time depends on the person conducting the exam. Primarily, it's our training,
education, and experience that determine how quickly we can obtain a useful image, and thus, the
length of the exam and the amount of exposure. So, the question is 'How much time do we need to
obtain the desired diagnostic information?'" The AIUM also lists some other factors that might affect
the length of exposure time, like if there is a moving or a stationary beam, what kind of transducer is
chosen, what is the body characteristic of the patient, if the operator is understanding the controls of
the system, and how they affect output levels, whether it's continuous or pulsed, or color flow Doppler.
"To achieve ALARA, we need a thorough knowledge of the imaging mode, transducer capabilities,
system setup, and operator scanning techniques."
GE Medical Systems-Kretztechnik Ultrasound therefore recommends careful studying of the
system's manual to become familiar with the operating controls and output display of the system
as well as with following the ALARA
biological hazard caused by ultrasound exposure during an examination!
Reference:
Please note that the above referenced AIUM publication is attached to this manual.
Medical Ultrasound Safety, AIUM 1994
AIUM Executive Office
14750 Sweitzer Lane,
Suite 100, Laurel, MD 20707-5906, USA
principle. This might decrease the risk of any potential
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2.13.8 Notes for Acoustic Output Tables for Track 3
Operating Conditions: means the adjustment of the scan parameters on the ultrasound console
MI: is the Mechanical Index in an auto-scanning mode.
TIS
TIS
:
scan
non-scan
TIB: is the Bone Thermal Index.
TIC: is the Cranial Thermal Index.
A
:
aprt
p
:
r.3
W0: is the ultrasonic power, except for TIS
W.3(z1): is the derated ultrasonic power at axial distance z1.
I
SPTA.3(z1
z1: is the axial distance corresponding to the location of max[min(W.3(z).I
zbp:
For MI, zsp: is the axial distance at which p
deq(z):
fc:
EBD:
1 - 12
PD: is the pulse duration (microseconds).
PRF: is the pulse repetition frequency (kilohertz).
is the Soft Tissue Thermal Index in an auto-scanning mode.
is the Soft Tissue Thermal Index in a non-auto scanning mode.
:
is the area of the active aperture (square centimeters).
is the derated Peak Rare factional Pressure (megapascals).
, in which case it is the ultrasonic power
scan
passing through a one-centimeter window (mill watts).
): is the derated spatial-peak, temporal-average intensity at axial distance z1 (mill watts
per square centimeters).
(z) * 1
TA.3
cm2)], where z³zbp (millimeters).
is 1.69(A
aprt
)
1/2
.
is measured; for TIB, zsp is the axial distance at
r.3
which TIB is a maximum (i.e. zsp = z
) (millimeters).
b.3
is the equivalent beam diameter as a function of axial distance z, and is equal to
[(4/p)(W0/ITA(z))]
1/2
, where ITA(z) is the temporal-average intensity as a function
of z (millimeters).
is the center frequency (megahertz).
are the entrance beam dimensions for the azimuthal and elevational planes
(millimeters).
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Safety
pr at Pll
FL: is the focal length, or azimuthal and elevational lengths, if different (millimeters).
ROC: is the radius of curvature (millimeters).
deq at Pll
Reference:
max
max
is the peak rare factional pressure at the point where the free-field, spatial peak pulse
:
intensity integral is a maximum (megapascals). (See section 6 of the Standard for
Real-Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound
Equipment, entitled "Measurement Methodology for Mechanical and Thermal
Indices", § 6.2.6.1.)
is the equivalent beam diameter at the point where the free-field, spatial-peak pulse
:
intensity integral is a maximum (millimeters). (See Section 6 of the Standard for
Real-Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound
Equipment, entitled "Measurement Methodology for Mechanical and Thermal
Indices", § 6.2.6.1.).
Acoustic Output Tables (acc. to Track 3 as demanded in the Revised 510(k). Diagnostic Ultrasound
Guidance for 1993; CDRH, FDA; Feb. 17, 1993), respectively guidance Information for Manufacturers Seeking MarketingClearance of Diagnostic Ultrasound Systems and Transducers
issued on September 30, 1997:
Please read the safety section for the complete explanation of the acoustic output in the User’s Manual
of the respective probes.
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Safety
2.14 3D-Resolution and Sensitivity
• All resolution and sensitivity claims are based on phantom testing only.
These claims do not directly correspond to or imply clinical performance.
NOTE:
DESCRIPTION OF Dr. MADSEN'S PHANTOM
The phantom is designed and constructed by Ernest L. Madsen, Ph. D., in the Department of Medical
Physics at the University of Wisconsin Medical School.
This 3D ultrasound phantom contains two sets of spherical targets. All spherical targets in the same set
have coplanar centers and the same diameter and identical contrastsa over the total depth of 15cm.
The center-to-center separation between adjacent spheres is 0.5cm in the vertical plane and 1.5cm in
the horizontal plane.
We can reconstruct high contrast spherical images in the 3 to 5 mm diameter range in 3 orthogonal
planes only for targets that have negative contrast of at least -17dB (for 3mm and 4mm) / -14dB (for
5mm) backscatter relative to the background level (based on Dr. Madsen's phantom).
This is because the -17dB / -14dB contrast levels were the only high contrast levels tested.
• We can detect large targets, i.e., spheres of 3, 4, and 5 mm in diameter.
• We can detect large targets, i.e., sphere of 5 mm or larger in diameter.
NOTE:
Significant system artifacts may exist in the orthogonal plane parallel to the face of the probe.
a
Defining the backscatter coefficient of the material forming the lesions to be B
background material to be Bbg, the contrast is defined (in dB) as 10 log10 (Bl / Bbg).
All system claims made are based on testing done with Dr. Madsen's phantom.
Dimensions (h x w x d): 20cm x 18cm x 8cm
This pertains only high contrast large targets (i.e., contrast of -17dB / -14dB or higher).
This pertains only low contrast large targets (i.e., contrast of at least +3dB).
The resolution in orthogonal, reconstructed plane is considerably lower than that of the
primary scan plane. The system resolution is particularly lower for low contrast targets in the
reconstructed, orthogonal plane.
and that the
l
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Safety
2.15 Measurement Accuracy of the System
Measurements must never be made in a hurry, accurate positioning of the measuring cross or
measuring dots is necessary especially with area/circumference measurements.
Despite the high technical accuracy of the scan geometry and the measuring system of the
VOLUSON® 730 equipment one must, however, be aware of inaccuracies caused by the ultrasound
beam properties and the physiological properties of the scanned structures, tissues and fluids.
For the reason of improved lateral resolution you should choose the proper scanhead for the depth
range of the structure to be measured.
The table shows the inaccuracies to be taken into account for measurements.
Accuracy Range
Distance +/- 3 % range of the system according to German KBV-regulations
Area +/- 6 %
Circumference +/- 3 %
Volume +/- 9 %
Explanation:
Distance error: < +/- 3% (or max. 1mm for an object < 30mm)
Area: < +/- 6% = Distance 1 x Distance 2
Volume: < +/- 9% = Distance 1 x Distance 2 x Distance 3
a) Test Phantom: Multi-purpose phantom, Model 539, from ATS Laboratories Inc,
b) Wire Grid phantom in water bath at 47° C, accuracy of wire spacing 0.2 mm
2.16 Disposal
When disposing “Follow local governing ordinances and recycling plans regarding disposal or
recycling of device components”.
The instrument does not pose any unusual threat when disposing of it.
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Description of the System
3. Description of the System .............................................................................................3-2
3.6.1Function of the Trackball at Diverse Dialog Pages ...................................................... 3-17
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Description of the System
3. Description of the System
3.1 Product Description
The VOLUSON® 730 is a professional, innovative, most versatile real-time scanning system.
It opens new sonographic possibilities with 3D/4D-VOLUME scanning technique.
The vast program of probes makes it suitable for many applications.
The system offers the following diagnostic possibilities:
The operation is designed for the specific clinical requirements and ensures simple and efficient
handling. A vast range of measuring and evaluation programs, as well as many special functions
enable comfortable working. An SCSI-interface with interface software provides quick digital
archiving of images and/or volume data sets on mass storage medium.
A network interface(Ethernet) provides documentation in DICOM-standard.
Under the provision of regular maintenance by authorized service personnel the life expectancy is
about 10 years from the manufacturing date.
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®
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Description of the System
3.1.1 Biological Safety
The biological effects of diagnostic ultrasound on the human body have not been entirely investigated
yet. So far no damages by ultrasound diagnosis are known, still the instrument should only be used by
a medical doctor or under his supervision.
The ultrasound examination should be performed in as short of a time as possible and with the lowest
transmit power available to enable diagnostic results (ALARA principle, As Low As Reasonably Achievable).
The VOLUSON® 730 permanently controls the emitted power and limits it acc. to the maximum
values set by the manufacturer (sound field limiting vector). The occurring sound intensities depends
on the respective probes. The declaration of sound field parameters acc. to IEC 1157 can be obtained
from the manufacturer on request.
3.1.2 Limitation Vectors
The table shows the limits for the following FDA and IEC parameters.
naming unit limits
FDAversion
limits
IECVersion
Ispta.3 mW/cm² 720 720
pr MPa - 4.0
MI - 1.9 -
TIB - 4.0 -
TIS - 4.0 -
TIC - 4.0 -
DT °C 5.0 5.0
W mW - 333
These values are individual Presets for FDA or IEC, and can only be changed in the company.
Review also: Notes for Acoustic Output Tables for Track 3
(chapter 2.13.8)
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Description of the System
3.1.3 Bioeffects
One distinguishes between two acting mechanisms for the development of Bioeffects when exposing
the human body to ultrasound waves: Heat Generation and Cavitation.
Heat generation:
depending on the absorbed power and duration of exposure. A part of the heat is dissipated into the
blood stream.
Cavitation:
and liquid phase constitute strong local mechanical stress in the tissue. The degree of cavitation is
influenced by the gas content and the superficial tension of the tissue resp. of body fluid.
the ultrasound energy is absorbed by the tissue and warms it up, the amount of heat
due to a strong negative pressure gas bubbles appear. The permanent change between gas
3.2 Mechanical Design
3.2.1 System Configuration
MONITOR
rotate – and inclinable
CONTROL CONSOLE
rotatable
Touchpanel Display
Probe Holder
Loudspeaker
Place for different disk drives
Place for Printer and VCR
Standby switch
Probe connector module
Foot rest
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Description of the System
3.2.2 Mechanical Adjustment
The control console can be rotated 30° to the right.
TRANSPORT LOCK
There is a lever for locking and unlocking the control console, mounted at the front below the control
console. When preparing the system for transport, the lock shall be engaged in order to secure the
console against uncontrolled rotation. The bolt set to the locking position, the lock catches in when the
console is rotated to its center 0° position.
ROTATION OF THE CONTROL CONSOLE
When rotating the control console grasp it only at the front handle of the user interface.
1. Pull the lever under the control console forward.
2. Rotate the console to desired position.
WARNING:
MOVING OR LIFTING THE SYSTEM
• Do not put your hand between the control console and
the main unit when moving it to the 0 position:
Danger of injuries!
• Do not pull or lift the system with the front handle of
the user interface.
When pulling, moving or lifting the system, grasp it only at
the rear handle of the trolley and the handle underneath the
foot rest.
CAUTION:
Two people are required whenever a part weighing 16 kg
(35 lb.) or more must be lifted.
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Description of the System
3.3 System Assembly
3.3.1 Basic System
It consists of the following modules:
1. Probe connector module:
This module houses the entire electronics with for connections, up to 3 probe connectors and the
beamformer module (transmit and receive electronics).
2. Control console:
The control console consists of the touchpanel, the hard keys, digipots and trackball, the loudspeakers,
and the probe holders.
3. Color monitor
4. Trolley:
All modules mentioned above are arranged within the trolley. There are 4 wheels. The front wheels are
equipped with locking brakes. Underneath the control console is space for auxiliary equipment
(e.g., SCSI-drives).
5. Doppler module:
Spectral Doppler module enables the evaluation of blood flow ratios with pulsed and continuous wave
and is built into the main electronic module.
Color-Doppler module enables color-coded evaluation of blood flow conditions and is built into the
main electronic module.
3.3.2 Optional Modules
Optional modules (CW-Doppler, 3D and 4D Real Time, etc.) according to the pricelist of the
Voluson 730.
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Description of the System
3.3.3 Optional Peripheral
Video Printer (black/white)
Digital Color Printer (SCSI, USB)
Line Printer
Videotape Recorder (S-VHS)
Footswitch
ECG preamplifier (MAN)
Actual type review product catalog of Voluson® 730.
WARNING !
Remark:
Connection of auxiliary equipment, see: To connect internal and external Accessories
The leakage current of the entire system including any/all auxiliary equipment must
not exceed the limit values as per EN60.601-1:1990 (IEC 60601-1) resp. other valid
national or international standards.
Optional devices (Printer, VTR, etc.) according to the pricelist of the VOLUSON 730
unit fulfill the electrical safety requirements.
(chapter 6.2).
Respectively see (chapter 20.2) of the Basic User Manual for Voluson® 730
3.4 Concept of Operation
The control center is the console with the digipot controls , the hardkeys and the trackball arranged
below it. They are controlling frequently used functions, e.g. Freeze/Run , change of modes etc.
Additional functions are controlled via the touchpanel.
TOUCHPANEL
The touchpanel consists of the flat control monitor.
Note:
The touchpanel could be blocked by direct sunlight - avoid full sunlight.
The touchpanel will be blocked by any foreign body lying on it, or e.g. by remainder of
coupling gel - clean the touchpanel regularly (with a wetted soft cloth).
The touchpanel enables a comfortable control of menus.
Only those touch keys are provided which are necessary for the activated menu.
The touchpanel eases working under dim light condition.
DIGIPOT CONTROLS, TRACKBALL
Activated functions are easily controlled by these controls. When rotated they deliver digital pulses
and can be selected by program call-up. They are displayed on the touchpanel screen by their location,
their function, and their actual value of setting.
A dual function is marked e.g.: [β-View] [Zoom].
Touching the corresponding symbol causes switching to the second function.
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Description of the System
3.5 Layout of menus
Survey:
Mainly two menu levels are used for operating the system, the main-menu level and the sub-menu
level. From the main menu the most important sub-menus, e.g. adjusting the 2D image are directly
accessible. Some hardkeys activate a specific sub-menu on the touchpanel, e.g. the disc key.
Normally changing from one sub-menu to another is made via the main menu, direct call-up from one
to another sub-menu is possible in some rare cases only.
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Description of the System
3.5.1 Layout of the 2D-Mode Main Menu
All B-Mode operations are started from this menu. It contains 4 main groups of operating functions:
Main group 1:
Presets
Main group 2:
adjusting the 2D image
Main group 3:
System Setup
Main group 4:
Remarks:
Selecting a new mode displays a new “Main” menu with the operating functions of this mode.
The keys for the functions Focus, OTI, β-View, Frequency, Angle, Trapezoid mode, FFC and CRI
only appear on the touchpanel if they are available for the selected probe.
Example:
Main menu keys for:
Sub window probe dependent functions
Image up/down
Image left/right
Trapezoid mode
FFC (Focus and Frequency Composite)
CRI (Compound Resolution Imaging)
Image Angle
β-View (Beta View)
Focal Zones
OTI (Optimized Tissue Imaging)
Frequency
Sub menu keys for:
Menu Others keys
Biopsy
Histogram
etc.
Change from write-only functions to read-only functions when changing read/write
(Freeze/Run):
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Description of the System
3.5.2 Changing of Menus
Each menu has its own menu key with a "topic" name. By touching the menu key the referring menu
appears on the touchpanel. The keys for the different sub-menus can be found next to the Menu main
key on the touchpanel.
The [Utilities] key is available in all main menus in the top right corner of the touchpanel.
Remark
:
If no probe is selected, the "PROBE/PROGRAM" menu is displayed.
3.5.3 Position of Display Annotation
1.)
2.)
3.)
4.)
5.)
6.)
7.)
8.)
9.)
10.)
Patient Name (family, given, prefix)
Hospital ID
Date
Time
Depth / Frame rate
Probe / Application
ID Number
Logo
Orientation marker
Focal zone marker(s)
11.)
Gray scale wedge
Depth scale marker
12.)
Image Info
13.)
TGC curve
14.)
Image area
15.)
Status bar
16.)
Measurement results
17.)
Body marker
18.)
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®
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Description of the System
Image Info:
B (2D) Mode
User program
7.5-5.0
Pwr -3
Gn -12
C5 / M7
P6 / E4
MI 0.4
TIS 0.0
Image Info:
Gn 10
150/C1
EE 1
Rej 10
Image Info:
Gn 10
WMF mid
SV Angle 60°
Size 2.5 mm
Frq mid
PRF 1.2 kHz
Image Info:
Name of user program
Receiver frequency [MHz]
Acoustic power [dB]
Gain [dB]
Dynamic curve [number], and Gray map [number]
Persistence [number] and Edge enhancement [number]
Mechanical Index
Thermal Index
M Mode
Gain [dB]
max. Dynamic range [dB] and selected Dynamic curve [number]
Edge enhancement [number]
Reject [number]
D (PW, CW) Mode
Gain [dB]
Wall motion filter [Hz]
Angle correction
Sample volume size
Transmit frequency [Probe data]
Velocity Range [kHz, cm/s, m/s]
CFM-Mode, PD-Mode
User program
7.5-5.0
Pwr -3
Gn -12
C5 / M7*
P6 / E4
MI 0.4
TIS 0.0
Name of user program
Receiver frequency [MHz]
Acoustic power [dB]
Gain [dB]
Dynamic curve [number] and Gray map [number]
Persistence [number] and Edge enhancement [number]
Mechanical Index
Thermal Index
Gn 60
Bal 120
Qual mid
WMF mid
PRF 1.2 kHz
Displ. V
Gain [dB]
Balance [number]
Quality of CFM [table]
Wall motion filter [table]
Velocity Range [kHz, cm/s, m/s]
Display Mode [wedge]
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Description of the System
3.5.4 Control Panel
1. Loudspeaker positions
2. Touchpanel screen
3. Probe holder
4. TGC Slider control
5. Touchpanel digipot and toggle switch controls
6. Mode keys (digipot controls)
7. Toggle switch controls
8. Trackball
9. Hardkeys
10. Keyboard
11. Grip for moving the unit and rotating the control console
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Description of the System
3.6 Hardkeys
NOTE:
The chapter references refer to the Basic User Manual for Voluson® 730.
Read/Write (Freeze/Run)
when bright: image is frozen (Read-Mode)
when dark: real-time scan (Write-Mode)
review: To freeze an Image
(chapter 4.5.2)
Printer Trigger A
Remote trigger key for B/W-Printer, Color printer, DICOM Printer
key setup review: Peripherals
operation review: Printing
(chapter 17.3.3)
(chapter 16.1)
VCR Remote control menu
operation review: VCR Recording
(chapter 16.2)
Storage (Inter-memory)
to save images, volumes as well as cine sequences in the Sonoview or to send them to
an external DICOM server
operation review: Sonoview
(chapter 15) and Saving (chapter 16.3)
Depth
select the display depth of the 2D image
operation review: 2D Mode Depth
(chapter 5.2)
Focus
select the position of the transmitter focus
operation review: Transmitter Focus
(chapter 5.7)
Power
set the acoustic output of the system
operation review: Transmit Power
to clear graphics, measurements and annotations on the screen
Bodymark
enter Bodymark symbols on the screen
operation review: Pictogram
(chapter 4.7.4)
Image Annotation
write onto the screen for documentation
operation review: Image Annotation
(chapter 4.7)
Volume Mode
activates activates 3D Volume Mode, Real Time 4D Mode, Live 3D Mode,
VCI (Volume Contrast Imaging), Real Time 4D Biopsy and VOCAL.
operation review: Volume Mode
(chapter 11)
Harmonic Imaging
on/off key for Harmonic Imaging
review: Harmonic Imaging
(chapter 5.8.1)
Continuous wave Doppler
on/off key for Continuous Wave Doppler
review: CW Mode
(chapter 7.2)
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®
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Description of the System
no function
Screen Format
select the display format (Quad and Dual screen display)
operation review: Single-Screen Format
press this key to shift from scan mode to Sonoview
operation review : Sonoview
(chapter 15)
Probe Program
call-up of the Probe Program menu for selecting a Probe with its related program
operation review: Probe/Program Selection
(chapter 4.5)
Patient Data Entry
call-up of the patient data entry menu (the previous exam will be closed).
operation review: Entering Patient Data
(chapter 4.6)
End Exam
Patient and measurement data are stored in the “Data manager” and a “default” set
occurs (all temporary patient and measurement data are cleared).
operation review: End Exam
(chapter 4.6.1.1)
Caution:
It is absolutely necessary to press this key before switching OFF the system.
Otherwise, the current Patient data as well as all the measurements in the Patient
report will be lost.
Printer Trigger B
Remote trigger key for B/W-Printer, Color printer, DICOM Printer
key setup review: Peripherals
operation review: Printing
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(chapter 17.3.3)
(chapter 16.1)
Description of the System
Indicator (Screen arrow)
display a pointer arrow or hand
operation review: Indicator
2D Mode (all additional Modes will be switched off)
review: 2D Mode
(chapter 5)
Pressing this control activates the 2D mode.
Rotating allows setting of the 2D image gain within the probe-defined range.
review: 2D Gain
(chapter 5.4)
Color Doppler (on/off)
Pressing starts the CFM mode provided the active probe allows function.
Rotating allows setting of the Color-Doppler (CFM mode) gain within the probedefined range.
With active 3D function on, rotate the control for slicing within the volume.
review: CFM Mode
(chapter 8)
Pulsed Wave Doppler (on/off)
Pressing starts the PW Doppler mode provided the active probe allows function.
Rotating allows setting of the Pulsed Wave Doppler (PW mode) gain within the
probe-defined range.
With 3D-function on, rotation around the Z-Axis within the volume.
review: PW Mode
(chapter 7.1)
Power Doppler (on/off)
Pressing starts the PD mode provided the active probe allows function.
Rotating allows setting of the Power-Doppler (PD mode) gain within the probedefined range.
With 3D-function on, rotation around Y-Axis within the volume.
review: PD Mode
(chapter 9)
Motion Mode (on/off)
Pressing starts the M mode provided the active probe allows function.
Rotating allows setting of the Motion mode (M mode) gain within the probe-defined
range.
With 3D-function on, rotation around the X-Axis within the volume.
review: M Mode
(chapter 6)
(chapter 4.7.3)
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Description of the System
3.6.1 Function of the Trackball at Diverse Dialog Pages
In general operations at diverse dialog pages and windows on the system desktop (e.g., Patient Data
Entry, Usage of EUM, System Setup, Measurement Setup, etc.) are done with the trackball and the
trackball keys (mouse emulation).
Trackball (mouse position):
positions the pointing device (arrow) on the desktop
left trackball key (left mouse button):
sets, fixates markers and activates pages/buttons etc. marked by the pointing device
upper trackball key (right mouse button):
no function in system desktop
right trackball key (left mouse button):
sets, fixates markers and activates pages/buttons etc. marked by the pointing device
The status bar shows the current trackball functionality:
↑ ↑ ↑ ↑ trackball left trackball key upper trackball key right trackball key
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Starting the System
4 Starting the System ..........................................................................................................4-2
4.1 General Remarks .................................................................................................................4-2
4.5.1Starting the System......................................................................................................... 4-6
4.5.2To freeze an Image ......................................................................................................... 4-6
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®
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Starting the System
4 Starting the System
4.1 General Remarks
Installation, switching on for the first time and check-up of the system must only be performed by
authorized persons.
The VOLUSON® 730 is delivered with recommended basic settings. These offer suitable conditions
for a large number of applications. Depending on the user's experience these default settings can be
changed and stored as new User Programs. Storing these programs or quick loading of new programs
of a second user is done by back-ups.
4.2 Safety Warnings
CAUTION !
CAUTION !
In the event the equipment has been brought from cold environment (stock
room, airfreight) into a warm room, allow several hours for temperature balance
and passing of condensation humidity before switching on the first time (risk of
leakage current).
The system is equipped with mains outlets separated by an isolation transformer
for peripheral equipment (printer, VCR). To ensure electrical safety, these
instruments must never be connected to a wall socket.
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Starting the System
4.3 Turn on Power
1. Connect the Power Cable to the back of the system.
2. Connect the Main Power Cable to a hospital grade power receptacle with the proper rated voltage.
WARNING:
3. Switch ON the Circuit Breaker and the Power Switch of Peripherals at the rear of the system.
Note:
The switch of the monitor has to be in ON position before starting the system.
Never use an adapter that would defeat the safety ground.
Leave monitor power switch always ON.
4. Push the ON/OFF Standby switch left below the control panel once.
For its location review: System Configuration
(chapter 3.2.1).
Once system is switched on, it is completely reset. The boot-up time is about 2 minutes, and then the
2D mode main menu for the previously selected transducer is displayed.
In case, however, it was disconnected, the menu "PROBE/PROGRAM" will appear.
Remarks
:
• The mains outlets of the system for peripheral auxiliary equipment are commonly switched
with the Standby switch. The switch of printers has to be in ON position before starting the
system. However, be aware some auxiliary equipment may switch itself to standby mode when
Standby power is on (e.g., Color video printer) and must therefore be switched on separately.
The auxiliary equipment need not be switched ON/OFF separately if the F2 power switch on the
back of the system and the switches of the peripherals are always ON.
• The system’s monitor has its own main switch, which is normally always left ON.
If found off, resp. if here is no information on the screen, switch it on.
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Starting the System
4.4 Transducer Connection
CAUTION!
CAUTION!
Prior to connecting or disconnecting a probe freeze the image.
It is unnecessary to switch the unit off.
If a probe is disconnected while running (write mode) a software error may
occur. In this case switch the unit OFF and later ON (perform a reset).
If the cable spout on the right-hand door is missing do not pull on the probe
cable, the probe cable can be damaged. Please insert the spout in the destined
place or call the Service Department.
1. Plug the probe connector into a free socket.
2. Twist the probe twist lock lever to vertical position to lock
it in place.
3. Open the right-hand side door.
4. Lay the cable into the intended cable holder and close the
door.
Each probe connector has a mechanical fixation lock which has to be engaged to enable the probe to
be working at all.
Probe Connector:
shown unlocked. Turn the knob clockwise to lock.
Note:
A disconnection of an active probe is permitted in read mode only !!!
If a probe is disconnected while running (write mode) a software error can occur!
Probe holders:
Always store the probes in the intended probe holders.
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Starting the System
4.5 Probe/Program Selection
This menu shows the connected probes.
The denomination of each transducer connected to the system appears in the corresponding touchkey
(soft key). Probe selection is done by touching the corresponding key. The key with the selected probe
is illuminated. At the same time the available applications of the selected probe are displayed in the
application field.
Upon selection of an Application, a maximum 7 User program fields appear in the “Settings” field,
and a default setting. The Default Setting is not rewriteable for the User.
Program selection is done by pressing the corresponding keys.
For each probe up to 7 programs can be stored.
The Setting enables speedy adjustment of the system for different fields of application.
To store a user setting under an application, review: User Settings
Manual for Voluson
®
730.
[Probe] key (hard key):
This key activates and deactivates the "probe select" menu.
Behavior of probe select function, when connecting/disconnecting a probe,
review: Transducer Connection
(chapter 4.4)
Probe selection menu on the touchpanel:
(chapter 17.3.2)of the Basic User
Probe window:
Shows all connected probes,
the active one is highlighted
(if one is active)
Application window:
Shows all applications for the
active probe. The last active
application is highlighted.
Setting (program) window:
Shows all settings for the active
application. The last active setting
is highlighted.
Selection of a probe:
Touch the corresponding probe key.
Each touch key shows the name of the responding probe. The selected probe is indicated when its key
is highlighted. At the same time the “Application” fields appear. Upon selection, the programmed
“Settings” come into view (8 setting keys for selection of the desired setting).
For starting the system review: Starting the System
(chapter 4.5.1).
Voluson
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730 - Instruction Manual
Starting the System
4.5.1 Starting the System
Touch a setting key.
Touching a setting key causes loading of the preset.
The probe is initialized, the main menu (2D mode) appears on the touchpanel and the ultrasound
image appears on the monitor in write mode (real time display).
Pressing the [Freeze] key causes loading of the selected (highlighted) setting.
Same function as when pressing a setting key.
Exit: return to the previously used active mode menu (2D mode,
M mode, .....) without any changes
Note:
Soft key [Exit] and hard key [Probe] provide the same function.
You may exit eventually by one of the keys, if no change of a probe or an application was made.
If a change was made in the “Application” field, the key turns dark (disabled). In this case an exit is
only possible by selecting a setting.
4.5.2 To freeze an Image
Freeze/Run-key (hard key)
Storing of the image by pressing the [Freeze] key:
Bright key:
Dark key:
read mode (image is stored, probe deactivated)
write mode (real-time is on, probe activated)
Voluson
®
730 - Instruction Manual
4-6 105838 Rev. 3
Electronic User Manual (EUM)
5 Electronic User Manual (EUM)......................................................................................5-2
5.1 To Exit the Electronic User Manual .................................................................................. 5-2
5.3 Help Book - Navigation Tools............................................................................................. 5-4
5.3.1To View the Contents..................................................................................................... 5-4
5.3.2To Use the Index ............................................................................................................ 5-5
5.3.3To Search for a Topic ..................................................................................................... 5-6
5.3.4To Save a Favorite Topic ............................................................................................... 5-7
Voluson
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®
730 - Instruction Manual
Electronic User Manual (EUM)
5 Electronic User Manual (EUM)
Press the [F1] key on the keyboard to invoke the electronic user manual.
The EUM screen appears (e.g.: 2D Mode)
The Help screen is divided into three sections:
1. Navigation Tools
2. Help Book - Navigation Tools
3. Content portion on the right side of the screen where help topics are displayed
on the top, left portion (Hide, Back, Forward, Print, Options)
on the left portion of the screen (Contents, Index, Search, Favorites)
5.1 To Exit the Electronic User Manual
To exit the electronic user manual, click the [X] symbol on the upper right edge in the Help window.
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730 - Instruction Manual
Electronic User Manual (EUM)
5.2 Navigation Tools
[Hide] the Help book navigation tools on the left portion of the screen.
To go back to the previous selected topic.
To view the topic which was displayed before clicking the [Back] button.
To print the selected topic or the selected heading and all subtopics.
To view the left side of the screen again, click the [Show] icon.
Choose the desired printer,
select the “Page Range” and
click the [Print] button.
Caution:
Please be aware that changes
and modifications, which are
not related to installing printers
and adjusting printer settings
may cause system dysfunction.
Do NOT change the “Default
Printer” setting. This will
change also the “Report Printer”
setting in the System Setup.
To adjust different functions (e.g. Search Highlight ON/OFF).
Voluson
105838 Rev. 3 5-3
®
730 - Instruction Manual
Electronic User Manual (EUM)
5.3 Help Book - Navigation Tools
Online Help is organized like a manual, with individual chapters, sections and pages.
Click on the Help book navigation tools on the left portion of the screen:
• To View the Contents
(chapter 5.3.1)
• To Use the Index
• To Search for a Topic
• To Save a Favorite Topic
(chapter 5.3.2)
(chapter 5.3.3)
(chapter 5.3.4)
5.3.1 To View the Contents
1. Click on the [+] sign next to the chapter you want to view to open up that section.
2. Open up the page to view that page’s information.
The blue, underlined text links you to related topics.
After you click on the blue, underline text, the screen updates with this link’s content.
To return to the previous screen click [Back]. To return to the link, click [Forward].
Voluson
®
730 - Instruction Manual
5-4 105838 Rev. 3
Electronic User Manual (EUM)
5.3.2 To Use the Index
1. Click on the “Index” tab. A list of topics - arranged in alphabetical order - will be displayed.
2. Use the scroll bar to look up a topic.
3. Either double click the desired topic to view, or highlight the topic and click the [Display] button.
Voluson
105838 Rev. 3 5-5
®
730 - Instruction Manual
Electronic User Manual (EUM)
5.3.3 To Search for a Topic
1. To search for a specific topic, click on the “Search” tab.
2. Type in the topic name in the Type in the keyword to find: field.
Topics with the word or phrase you typed appear in the Select Topic to display: area.
3. Either double click the desired topic to view, or highlight the topic and click the [Display] button.
Voluson
®
730 - Instruction Manual
5-6 105838 Rev. 3
Electronic User Manual (EUM)
5.3.4 To Save a Favorite Topic
You may find that there are topics you need to refer to often. In this case, it is a good idea to save
these topics as Favorites.
1. To save a topic as a favorite, click on the “Favorites” tab.
2. Highlight the topic in the Topics: field and click the [Add] button.
You can now view this topic quickly by going to the Favorites help tab.
6.3 Important Notes: Connecting Auxiliary Equipment...................................................... 6-19
Voluson
105838 Rev. 3 6-1
®
730 - Instruction Manual
Connections
6. Connections
6.1 How to connect Auxiliary Devices safely
Basic Concept:
The Voluson® 730 is equipped with an isolation transformer to provide the required separation from
mains for both the system and auxiliary devices. These mains outlets are accessible at the rear of the
unit after removing the rear panel.
Video Copy Processor (VCP), Video tape recorders (VTR) are to be connected here as described in
chapter Connections.
The Voluson® 730 provides several inputs and outputs (I/O) such as Audio, Video, Ethernet, USB,
DICOM and Printer signals. Special care has to be taken when connecting these signals to other
devices.
The IEC 60601-1-1 standard provides a guideline for safely interconnecting medical devices in
systems.
“Equipment connected to the analog or digital interface must comply with the respective IEC/UL
standards (e.g. IEC 950/UL 1950 for data processing equipment and IEC 60601-1/ UL 2601-1 for
medical equipment). Furthermore all configurations shall comply with the system standard
IEC 60601-1-1. Everybody who connects additional equipment to the signal input part or signal output
part configures a medical system, and is therefore responsible that the system complies with the
requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service
department or your local representative.”
1.) The medical device may be connected to a single IEC XXX device ( protection class I) placed in a
room which is not medically used.
2.) If the device is to be connected in a medically used room the following rule applies:
a.) IEC 60601 compliant devices may be connected as such.
b.) IEC XXX compliant devices (protection class I) may be connected with an additional safety
measure.
For all situations 1 and 2, the additional device shall be installed outside the patient environment.
Additional protective earth connection between the 2 devices,
or a safety isolation mains transformer for the other device
Special care has to be taken, if the device is connected to computer network (e.g., Ethernet), because
other devices could be connected without any control. There could be a potential difference between
the protective earth and any line of the computer network including the shield.
In this case the only way to operate the system safely is to use an isolated signal link with minimum
4mm creepage distance, 2.5mm air clearance of the isolation device. For computer networks there are
media converters available which convert the electrical to optical signals. Please consider that this
converter has to comply with IEC xxx standards and is battery operated or connected to the isolated
mains output of the Voluson® 730. review: Connector Panel (rear Side)
Voluson
6-2 105838 Rev. 3
(chapter 6.2.5)
®
730 - Instruction Manual
Connections
Additionally the IEC60601-1-1 requires control measurement of leakage currents.
The system integrator (any person connecting the medical device to other devices) is responsible that
the connections are safe.
IEC XXX Stands for standards such as : IEC 60601 for medical devices
IEC 950 for information technology equipment etc.
6.2 To Connect internal and external Accessories
review:
Main Module
Power Supply (rear Side)
Power Supply (for Auxiliary Equipments)
Side of the Main Module-Connectors
Connector Panel (rear Side)
Color Video Monitor Connection
B/W Video Printer Connection Scheme
S-VHS Videorecorder Connection Scheme
Color Video Printer Connection Scheme (chapter 6.2.9)
Line Printer Connection Scheme
ECG-preamplifier (MAN 6) Connection
Foot Switch (MFT 7) Connection
Important Notes: Connecting Auxiliary Equipment
(chapter 6.2.1)
(chapter 6.2.2)
(chapter 6.2.3)
(chapter 6.2.4)
(chapter 6.2.5)
(chapter 6.2.6)
(chapter 6.2.7)
(chapter 6.2.8)
(chapter 6.2.10)
(chapter 6.2.11)
(chapter 6.2.12)
(chapter 6.3)
Voluson
105838 Rev. 3 6-3
®
730 - Instruction Manual
Connections
6.2.1 Main Module
Voluson
®
730 - Instruction Manual
6-4 105838 Rev. 3
Connections
1 VGA 1Connector for the internal color video monitor
2 VGA 2Connector for an external color monitor
3 R, G, B, H, V outputs for color video printer
Pin 1 : Red
2 : Green
3 : Blue
4 : Composite Sync
5 : V-Sync
4 S-VHS 1 OUT
5 S-VHS 2 OUT
6 Video out: 1Vss @ 75 Ohm, PAL
1Vss @ 75 Ohm, NTSC
Mains INMains voltage according to type plate Modification of voltage setting only
Possible mains voltages: 100V, 115V, 130V, 230V, 240V, AC only
F4, F5, F6, F7: T 10 Ampere /250V fuse Type: H (high breaking capacity)
Manufacturer: Schurter order Nr. 0001.2534 Type SPT
F2 On-switch for auxiliary devices:
Thermal Circuitbreaker T 2.5 Ampere / 230V reusable
T 5 Ampere / 115 V reusable
Manufacturer: E-T-A Type: 3120-F521-P7TI-W01A-X017 2.5/5A
by authorized service person!
Table for the Fuses used.
Potential equilibrium connection (rear panel)
Protective earth connection
Information plate for the adjusted voltage setting.
Modification of voltage setting only
by authorized service person!
Possible mains voltages: 100V, 115V, 130V, 230V, 240V, AC only
Connector for Foot Switch
review also: Important Instructions for Safety
To adjust the Foot Switch review: System Setup: Peripherals
Voluson
(chapter 2.1).
®
730 - Instruction Manual
(chapter 17.3.3).
6-6 105838 Rev. 3
Connections
6.2.3 Power Supply (for Auxiliary Equipments)
For auxiliary equipment
ST1-ST5 Mains OUT for auxiliary equipment
These outlets are fed from an isolation transformer which is switched with the F2 switch of the rear
side. This outlet voltage is not depending on the mains voltage.
CAUTION!
The sum of the power consumption of equipment connected to these outlets must
not exceed 350 VA (incl. the color video monitor)!
CAUTION:
Modification of voltage setting only
The outlets ST1 – ST5 may be set to 230V or 115V
by an authorized service person!
Voluson
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®
730 - Instruction Manual
Connections
6.2.4 Side of the Main Module-Connectors
1 USB-1 PORT Connector
2 USB-2 PORT Connector
3 Parallel port for PC-LINE PRINTER
4 RS232-2 (no function)
5 Connector for MOUSE/KEYBOARD
6 RS232-1 Connector for OPERATION PANEL
7 Connector for NETWORK twisted pair RJ-45 10/100 megabit/s
8 VGA (no function)
9 AUXILIARY SCSI
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®
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6-8 105838 Rev. 3
Connections
6.2.5 Connector Panel (rear Side)
10 11 12 13
1 2 3 4 5 6 7 8 9
1 VGA (OUTPUT) - print out VGA signal with monitor/printer
2 R, G, B, H/V SYNC - outputs for color video printer/monitor
3 NETWORK - DICOM input/output twisted pair RJ-45 10/100 megabit/s
review: How to Connect Auxiliary Devices Safely
or (chapter 22.16) of the Basic User Manual for Voluson 730.
(chapter 7.16),
(chapter 6.1)
Voluson
105838 Rev. 3 6-9
®
730 - Instruction Manual
Connections
6.2.6 Color Video Monitor Connection
CAUTION:
Modification of voltage setting only
Voluson
The outlets ST1 – ST5 may be set to 230V or 115V
by an authorized service person!
®
730 - Instruction Manual
6-10 105838 Rev. 3
Connections
6.2.7 B/W Video Printer Connection Scheme
(Mitsubishi P91E B/W / Sony UP 895 CE B/W
CAUTION:
Modification of voltage setting only
The outlets ST1 – ST5 may be set to 230V or 115V
by an authorized service person!
REMARK:
Voluson
105838 Rev. 3 6-11
Please use: Connection set PPP55
®
730 - Instruction Manual
Connections
6.2.8 S-VHS Videorecorder Connection Scheme
(Sony SVO-9500MDP)
12
3
4
56
Set DIP Switches on RS 232C interface board as shown:
On
Switch 1: OFF-Audio is muted during fast playback
Switch 2: OFF-FF/REW mode is used during searches.
Switch 3: ON-VCR counter is reset upon cassette ejection.
Off
Switch 4: OFF-The VCR can be controlled by the V730.
Switch 5 + 6: ON-The Baud rate is set to 19200 bit/sec
(must be the same as V730)
CAUTION:
Modification of voltage setting only
The outlets ST1 – ST5 may be set to 230V or 115V
by an authorized service person!
REMARKS:
Please use: Connection set PRR50
Remote cable KUG5
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®
730 - Instruction Manual
6-12 105838 Rev. 3
Connections
6.2.9 Color Video Printer Connection Scheme
6.2.9.1 Sony UP-D2600S
CAUTION:
Modification of voltage setting only
The outlets ST1 – ST5 may be set to 230V or 115V
by an authorized service person!
REMARK:
Please use: Connection set PZP50
NOTE:
The switch of the printer has to be in ON position before starting the system.
Leave printer switch always ON.
Voluson
105838 Rev. 3 6-13
®
730 - Instruction Manual
Connections
6.2.9.2 Sony UP-D21MD
CAUTION:
Modification of voltage setting only
The outlets ST1 – ST5 may be set to 230V or 115V
by an authorized service person!
CAUTION:
Pay attention to lateral distances. See Instruction Manual of the Sony printer!!!
CAUTION:
The Printer Supply Voltage must be the same as Output Voltage of Voluson730
Power Out Connectors (Power Supply)!
REMARK:
Please use: Connection set PZP60
NOTE:
The switch of the printer has to be in ON position before starting the system.
Leave printer switch always in the ON position.
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®
730 - Instruction Manual
6-14 105838 Rev. 3
Connections
6.2.9.3 Mitsubishi CP770DW
CAUTION:
The outlets ST1 – ST5 may be set to 230V or 115V
Modification of voltage setting only
by an authorized service person!
REMARK:
Please use: Connection set PZP50
NOTE:
The switch of the printer has to be in ON position before starting the system.
Leave printer switch always in the ON position.
Voluson
105838 Rev. 3 6-15
®
730 - Instruction Manual
Connections
6.2.10 Line Printer Connection Scheme
(HP deskjet 990cxi or HP deskjet 995c)
power
socket
CAUTION:
outside of the patient environment (acc. IEC 60601-1 / UL 2601-1).
REMARK:
Connection set PZP56 for HP 995c
NOTE:
Leave printer switch always in the ON position.
Please observe that the Line Printer type HP 990cxi / HP 995c has to be located
Please use: Connection set PZP55 for HP 990cxi
The switch of the printer has to be in ON position before starting the system.
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®
730 - Instruction Manual
6-16 105838 Rev. 3
Connections
6.2.11 ECG-preamplifier (MAN 6) Connection
Voluson
105838 Rev. 3 6-17
®
730 - Instruction Manual
Connections
6.2.12 Foot Switch (MFT 7) Connection
To adjust the Foot Switch review: System Setup: Peripherals
Manual for Voluson 730.
(chapter 17.3.3) of the Basic User
Voluson
®
730 - Instruction Manual
6-18 105838 Rev. 3
Connections
6.3 Important Notes: Connecting Auxiliary Equipment
CAUTION !
CAUTION !
CAUTION !
CAUTION:
Modification of voltage setting only
ATTENTION !
WARNING !
GE Medical Systems Kretztechnik GmbH & Co OHG may be used in
connection with the system.
The leakage current of the entire system including any / all auxiliary
equipment must not exceed the limit values as per EN60 601-1-1:1990 (IEC
60601-1-1) resp. other valid national or international standards.
All equipment must comply with UL, CSA and IEC requirements.
Auxiliary equipment must only be connected to the main console with the
special mains outlet provided for the electrical safety of the system.
Auxiliary equipment with direct mains connection requires galvanic
separation of the signal and / or control leads.
The outlets ST1 – ST5 may be set to 230V or 115V
by an authorized service person!
With the color video monitor connected to its isolated mains outlet, the
remaining load capacity for auxiliary equipment is max. 350 VA.
Only accessories explicitly recognized by the system manufacturer
7.19 MAN ECG preamplifier ............................................................................................... 7-14
Voluson
105838 Rev. 3 7-1
®
730 - Instruction Manual
Technical Data / Information
7. Technical Data/Information
TYPE: VOLUSON® 730
MODEL: VOLUSON® 730
SERIAL NUMBER
Position: Rear side of the Unit in the identification plate.
Identification plate
Example:
UL Classification Label
Voluson
®
730 - Instruction Manual
7-2 105838 Rev. 3
Technical Data / Information
7.1 Power Supply
Power requirements: 230V AC
100 V, 115V, 130V,
230V, 240V AC in compliance with UL 2601 when operated with
center tapped mains supply.
50 Hz, 60 Hz (± 2%)
Power consumption: nominal 1010VA
including all options
typical power consumption with 350VA load ST1 - ST5 approx.
4A at 230V/50 Hz
Perceived noise level: max. 57 dB/A
Mains outlets: Mains socket ST1, ST2, ST3, ST4, ST5 for accessories.
All mains outlets are co-switched by the unit’s mains switch via built-in
isolation transformer.
Output voltage for: ST1- ST5: 115V or 230V
Modification of voltage setting only
Output power: 350VA per mains outlet, max. power of all connected
accessories must not exceed 350VA.
EMC (Electro-Magnetic Compatibility): EN 60601-1-2:1994
Emission: EN55011 Group 1 Class A EN61000-3-2 Power line harmonics
Immunity: EN61000-4-2 (IEC1000-4-2): 2,4,8kV air discharge,
2,3,4kV contact discharge
EN61000-4-3 (IEC1000-4-3): 26- 1000 MHz 3V/m
EN61000-4-4 (IEC1000-4-4): 2kV burst on power lines
EN61000-4-4 (IEC1000-4-4): 1kV burst on data lines
EN61000-4-5 (IEC1000-4-5): 2kV differential mode
1kV common mode
EN61000-4-6 (IEC1000-4-6):
150 kHz-80 MHz, 3V (80% AM, 1kHz)
except area of effective frequency (1-16 MHz)
Electro-magnetic influence: In the working frequency range of the ultrasound system from 1 to 16
MHz an influence on the ultrasound image can be visible in the range
from 200...500mV/m depending on the probe connected.
Duty cycle: 100% on
Surge current limiter: built-in
Safety classification: Class I, applied parts type BF acc. to EN60601-1/1990 (IEC 60601-
1/1990)
by an authorized service person!
Voluson
105838 Rev. 3 7-3
®
730 - Instruction Manual
Technical Data / Information
Ambient temperature: 10°C to 40°C resp. 50°F to 104°F (operation temp. of instrument)
-10°C to 40°C resp. 14°F to 104°F (stock and transport temp.)
working temp. of probes see probe user’s manual
Barometric pressure: 700 to 1060 hPa (operation condition)
700 to 1060 hPa (stock and transport condition)
Humidity: 30 to. 80% RH no condensation (operation condition)
0 to. 90% RH no condensation (stock and transport condition)
Humidity protection: covered, no humidity protection
Over-temperature protection: yes, provided by three fans
Dimensions: 680 x 1000 x 1450 mm [width x depth x height]
26.7 x 39.4 x 56.1 in.
Weight: basic unit (without accessories) approx. 136 kg
7.2 Transmitter
Frequency range: Broad band system 1 to 16 MHz, automated adaptation to the probe
used.
Control of acoustic output: Range: 32 dB, adjustable in 1dB steps
Focusing: selectable transmit focal length and focal depth
Processing-channels: 512 channels
Sound field parameters: the declaration of the sound field parameters acc. to IEC1157 can be
furnished by the manufacturer on request. Sound field limiting
parameters on request.
7.3 Receiver
Frequency range: Broad band system 1 to 16 MHz, automated adaptation to the probe used.
Focusing (with annular and multi-element):
Sub-pixel based digital dynamic focusing system:
Accuracy of focus: +/- 3ns
Sample-rate: 60.0 MHz
Processing-channels: High resolution Mode: 512 channels
Receive-apodization: yes
TGC: manual, 100 dB control range by gain knob and slider-pots
Dynamic range: 150dB
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®
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7-4 105838 Rev. 3
Technical Data / Information
7.4 Scan Converter
Video memory size: 800 x 600 x 32 bit
Image memory: 4 MB
Gray scale values: 256 (8 bit)
Depth range: depends on used probe
Image lines: max. 1024
Scan angle: max. 360°
Aspect ratio: min. 0.25:1 to max. 8:1 (Write 5:1, Read factor 0.8 to 2.4),
incremental magnification, no loss of resolution.
M-Mode: M-Mode search line positionable at each scan line
M-Mode depth range: same as B-Image
M-Mode full screen scroll time: 300 / 225 / 150 / 100 Pixels/sec. (50 Hz) in relation to monitor width
Capacity: up to 256MB
typ. 3000 2D-images
Call-up of sequence: manual image by image
automated: 50 to 100% of real-time rate, liberal selection of start- and end
image
7.6 Display Modes
2D-scan: Single, Dual, Quad,
Trapezoid-Mode, Focus and Frequency Composite (FFC),
Compound Resolution Imaging (CRI), Harmonic Imaging,
β-View (Beta View)
2D-volume scan: Volume Contrast Imaging (VCI)
3D-scan: Multiplanar analysis, Volume scan
4D-scan: Real-time 4D, Real Time 4D Biopsy
M-Mode: 2D/M
Doppler-Mode: 2D/D horizontal Partition, three different formats 40/60, 50/50 and 60/40
Color Doppler Mode: 2D/CFM (Single, Dual, Quad), 2D/CFM/D, 2D+2D/C
Image orientation: left/right and up/down selectable
Voluson
105838 Rev. 3 7-5
®
730 - Instruction Manual
Technical Data / Information
7.7 Signal Processing
Persistence filter: 8 steps (pre)
Line filter: 3 steps (pre) off , low (12,5/75/12,5%) , high (25/50/25%)
Enhance: 6 steps (pre) 0 , 1 , 2 , 3 , 4, 5
Reject: 51 steps (pre) from 0 to 255
Gray scale dynamic: 9 basic curves and 3 User-defined (pre, post)
Dynamic: 12 different dynamic curves C1 - C12
Quality: 3 steps (pre) low , norm , high
7.8 Data Entry
Patient data: 1 line with 32 characters
Clinic/Doctor's name: 1 line with 32 characters
Auto Text memory: 40 user-programmable terms with 10 characters each.
7.9 Measurement and Calculation Programs
Basic Measurements: Distance: 2D Mode: Distance, Trace, Hip Joint
M Mode: Distance, Time, Velocity
D Mode: Acceleration Velocity + Pressure Gradient,
Velocity Ratio, Average Velocity
Program presets: max.5 applications, each application max. 8 settings
max. 40 settings per probe
Voluson
105838 Rev. 3 7-7
®
730 - Instruction Manual
Technical Data / Information
7.11 Volume Scan Module
Vol. scan size: 64 MB minimum
The required memory space depends on scan parameters (VOL-box
size and quality (low , mid1 , mid2 , high1 , high2).
typ.: 1-5 MB
Lines/2D-image: max. 1024 (typ. 80 to 350)
2D-images/volume: max. 1024 (typ. 50 to 250)
VOL-Frames/sec.: max 16 (typ: 3-6)
The frame rate depends on scan parameters (VOL-Box size, quality and probe.
Display of sectional plane images:
synchronous with control setting, arbitrary movement in volume,
monitored position in volume.
Rotation: 360°, 0.5° increments (X-, Y- and Z-axis)
Magnification: adjustable from 0.25 to a factor of 4.00
3D-Rendering: Calculation and display of rendered gray scale images:
surface mode, maximum mode, minimum mode;
calculation time depending on rendering box size
Calculation and display of rendered color-images:
3D PD Mode: surface mode, max. intensity mode
Display Modes: 3-section Mode:
A triplet of 3 sectional planes normal to each other is displayed.
Full-sized image:
Display of 1 single full-screen image.
Niche image:
Display of the sectional plane triplets within the (graphics) cube.
4 section mode:
Display of sectional images + calculated 3D images
Display graphics: Color display of the center of rotation and the axes.
Data interface: SCSI Bi-directional transfer of volume, image data sets between console
(Option) and mass storage medium.
Data transferred: volume, image data
date, time
clinic's name / doctor's name
patient data
control settings
No measurements and text data!
Pulse Repetition Frequency (PRF): 1.3 ...22 kHz
Sample Volume (Doppler Gate): Length: 1, 2.5, 6, 10, 15 mm
Position: 5 mm to B-scan end
Angle correction: - 85° … 0° ... + 85°
Power control range : 32dB
GAIN range: - 15 … + 15 dB
WMF (wall motion filter): 0...400 Hz
Zero line shift: ± PRF/2, ± 8 steps
Pulsed wave: 1cm/s.....3m/s (a = 0°, 3.5 MHz, max. zero shift)
1cm/s.....6m/s (a = 60°, 3.5 MHz, max. zero shift)
Continuous wave: 1cm/s...10m/s (a = 0°, 2.25MHz, max. zero shift)
1cm/s...20m/s (a = 60°, 2.25MHz, max. zero shift)
Signal processing: Reject: 6 steps
Dynamic range: 20 to 150 (step size = 5)
Measuring value display: kHz, cm/s, m/s
Image formats: D, 2D+D (three different formats 40/60, 50/50 and 60/40)
Simultaneous Mode: 2D/D, 2D/D/CFM and 2D/D/PD
Audio-Modes: Stereo (both directions separately in both channels)
Audio Volume, balance: Adjustable, control knobs
Voluson
105838 Rev. 3 7-9
®
730 - Instruction Manual
Technical Data / Information
7.13 Color Doppler
C-Mode:
Color flow imaging is possible with Curved Array, Linear Array and Phased Array probes.
Color coding steps: 8192 color steps
Depth range: axial: 0 to B-scan range
lateral: 0 to B-scan-range
Zero line shift: 17 steps (independent from spectral Doppler)
Inversion of color direction: yes
Wall Motion Filter: 7 steps
Smoothing Filter: 12 steps rising time
12 steps falling time
Gain control : 30dB
Density (color line density): 10 steps
Ensemble (color shots per line): 7 to 31
Pulse repetition frequency: 100 Hz to 20.5 kHz
CFM Map: 8 different color codes for each probe
Frequency range: 1 to 15 MHz depending on the probe,
adjustable in 3 steps (low, mid, high)
Balance: from 25 to 225 in 41 steps
Max. meas. velocity: 5.5 m/sec.
Min. meas. velocity: 0.3 cm/sec.
Display Modes: V-T (velocity + turbulence)
V (velocity)
V-P (velocity + power)
T (turbulence)
P-T (power + turbulence)
Scale: kHz, cm/s, m/s
Automatic moving tissue suppression: yes
Voluson
®
730 - Instruction Manual
7-10 105838 Rev. 3
Technical Data / Information
7.14 Tissue Doppler
TD-Mode:
Tissue Mode flow imaging is only possible with Phased Array probes.
Display Modes: 2D/TD (Single, Dual, Quad); 2D+2D/TD
TD coding steps: 8192 color steps
Depth range: axial: 0 to B-scan range
lateral: 0 to B-scan-range
Zero line shift: 17 steps
Inversion of color direction: yes
Smoothing Filter: 12 steps rising time
12 steps falling time
Gain control : 30dB
Density (color line density): 9 steps
Ensemble (color shots per line): 7 to 31
Pulse repetition frequency: 100 Hz to 13 kHz
TD Map: 4 different color codes for each probe
Frequency range: 1 to 15 MHz depending on the probe,
adjustable in 3 steps (low, mid, high)
Balance: from 25 to 225 in 41 steps
Max. meas. velocity: 5.0 m/sec.
Min. meas. velocity: 0.3 cm/sec.
Display Mode: V (velocity)
Scale: kHz, cm/s, m/s
7.15 Power Doppler
PD-Mode:
Power Doppler imaging is possible with Curved Array, Linear Array and Phased Array probes.
Display Modes: 2D/PD (Single, Dual, Quad); 2D+2D/PD
Simultaneous triplex mode: 2D/PD/D
3D/PD
PD coding steps: 256 color steps
PD window size: lateral: maximum to minimum B-Mode scan angle
axial: 0 B-scan range
Display Mode: P (power)
Wall motion Filter: 7 steps
Smoothing Filter: rising edge: 12 steps
falling edge: 12 steps
Gain control: 30dB
PD display ensemble: 7 to 31
PD display density: 10 steps
Pulse repetition frequency: 100 Hz to 20.5kHz
PD Map: 8 different color codes for each probe
Frequency range: 1 to 15 MHz depending on the probe,
adjustable in 3 steps (low, mid, high)
Image sequence memory: max. 128 images, 1024 images optional
Balance: from 25 to 225 in 41 steps
Artifact suppression: yes
Voluson
105838 Rev. 3 7-11
®
730 - Instruction Manual
Technical Data / Information
7.16 Interfaces
Video out BNC-socket
video norm: PAL/NTSC
FBAS-signal: 1Vss/75Ω
Video out BNC-socket
video norm: PAL/NTSC or black/white video (whiteout color carrier)
CCIR-signal: 1Vss/75Ω
Video in: BNC-socket
video norm: PAL/NTSC
FBAS-signal: 1Vss/75Ω
S-Video in/out: 1 x Mini DIN for IN
1 x Mini DIN for OUT
video norm: PAL/NTSC
Chrominance: in: 0.3Vss/75Ω
Luminance: in: 1.0Vss/75Ω
Mass: in: GND
Chrominance: out: 0.3Vss/75Ω
Luminance: out: 1.0Vss/75Ω
Mass: out: GND
RGB out: BNC -sockets
Red: 0.7Vss/75Ω
Green: 0.7Vss/75Ω
Blue: 0.7Vss/75Ω
Composite H/V-Sync: TTL-CMOS
Mass: GND
VGA out: Red: 0.7Vss/75Ω
Green: 0.7Vss/75Ω
Blue: 0.7Vss/75Ω Separate positive H/V-Sync: TTL-label
Audio in L: Cinch, LF-signal 1.2Vss
Audio in R: Cinch, LF-signal 1.2Vss
Audio out L: Cinch, LF-signal 1.2Vss
Audio out R: Cinch, LF-signal 1.2V
Footswitch in: BNC-socket: FREEZE/RUN
Freeze/Run in: TTL-CMOS, active low
Remote control out: BNC-socket: PRINT A
DIN-socket: PRINT B
Remote signal: TTL-CMOS, active low, Imax = 25 mA
RS232: VTR remote control
Net connection: Ethernet, IEC802-2, IEC802-3
Software: DICOM 3.0 standard
Voluson
7-12 105838 Rev. 3
ss
®
730 - Instruction Manual
Technical Data / Information
7.17 Monitor
SVGA Monitor : Type: Sony PGM -100 P1MD
Monitor resolution: 1280x1024 pixel (800x600 internally used)
Scanning frequency: Horizontal: 30 to 65kHz
Vertical: 50 to 120Hz
Nominal current: 100-120V 50/60 Hz 1.8A
220-240V 50/60 Hz 1.0A
Safety classification: Class I, Type B
Standards: EN60601-1 (IEC60601-1)
UL listed or classified
Mains switch: 2-pole single throw
Picture tube: 15" intrinsic-safe cathode ray tube acc. to annex III German X-Ray Regulation
Re-writeable Magneto Optical Disc 3 ½ “:
Storage capacity: 128MB, 230MB, 540MB, 640MB, 1.3GB
Ambient temperature:
Operating: 5°C - 55°C, 3-85 %RH
Storage: -10°C - 55°C, 3-90 %RH
Archival life time: min. 30 years
CD-RW drive: Re-Write Speed: Read 24x, Write 8x, Re-Write 8x
Access Speed: 140ms
Max Data Transfer (Read): 3600KB/sec
Buffer Size: 4MB
Archival life time: min. 30 years