Samsung Hs70 Service Manual

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HS70A
Service Manual
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(Empty page)
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HS70A
Service Manual
English
SM-HS70A-ENG-02
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Safety Requirements
■ Classifications
− Type of protection against electric shock: Class I
− Degree of protection against electric shock (when the patient is in physical
contact): Type BF or CF applied part
− Degree of protection against harmful ingress of water: Ordinary equipment
− Degree of safety of application in the presence of a flammable anesthetic
material with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
− Mode of operation: Continuous operation
■ „ Electromechanical safety standards met
− Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1:2005/A1:2012
− Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standards: Electromagnetic Compatibility - Requirements and Tests IEC 60601-1-2:2007
− Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standards: Usability IEC 60601-1-6:2010
− Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment IEC 60601-2-37:2007
− Medical Electrical Equipment, Part 1: General Requirements for Safety IEC 60601-1:1988, A1:1991, A2:1995
− Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral Standards: General Requirements for Medical Electrical Systems IEC 60601-1-1:2000
− Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility - Requirements and Tests IEC 60601-1-2:2001, A1:2004
− Medical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral Standards: Programmable Electrical Medical Systems IEC 60601-1-4:1996, A1:1999
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− Medical Electrical Equipment, Part 2-37: Particular Requirements for the
CSA mark with the indicators “C” and “US” means that the product is certified for both the U.S. and Canadian markets, to the applicable U.S. and Canadian standards.
This is the manufacturer’s declaration of product
compliance with applicable EEC directive (s) and the European notified body.
This is the manufacturer’s declaration of product
compliance with applicable EEC directive (s).
This is the GMP symbol for Korean Good Manufacturing Practice quality system regulation.
Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment IEC 60601-2-37:2001, A1:2004, A2:2005
− Medical Devices - Application of Risk Management ISO 14971:2007
− Medical Electrical Equipment, Part 1: General Requirements for Safety UL
60601-1:2003
− Medical Electrical Equipment - Part 1: General Requirements for Safety
CAN/CSA C22.2 No. 601.1-M90:1990, R2003, R2005
− Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing
ISO 10993-1: 2009
− Standard Means for Reporting the Acoustic Output of Medical Diagnostic Ultrasonic Equipment IEC 61157:2007
■ „ Declarations
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Precautions for Use
DANGER
Describes precautions necessary to prevent user hazards of great urgency. Ignoring a DANGER warning will risk life-threatening injury.
WARNING
Used to indicate the presence of a hazard that can cause serious personal injury, or substantial property damage.
CAUTION
Indicates the presence of a hazard that can cause equipment damage.
NOTE
A piece of information useful for installing, operating and maintaining a system. Not related to any hazard.
Read this service manual to familiarize yourself thoroughly with repair procedures and important safety information before attempting to service the product.
■ Refer to this service manual when you are servicing the product. Please familiarize yourself with the safety precautions in 'Chapter 1. Safety' and 'Chapter 4. Maintenance' in particular.
■ This product is an ultrasound diagnosis device and cannot be used for other purposes.
■ This product may only be serviced by a service engineer of Samsung Medison or an authorized engineer. Samsung Medison is not responsible for any problems caused by an unauthorized person servicing the product.
■ The manufacturer is not responsible for any damage to this product caused by user carelessness and/or neglect.
■ The content of this service manual is subject to change without prior notice.
■ Products that are not manufactured by Samsung Medison are indicated with the
trademarks of their respective owners.
■ The following terms are used to highlight safety precautions that the user must be aware of:
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Revision History
VERSION
DATE
REASON FOR CHANGE
v1.00.00
2015.07.07
Initial Release
V2.00.00
2016.09.22
Software upgrade / Parts change
The revision history of this manual is as follows:
If You Need Assistance
If you need any assistance with the equipment, please contact the Samsung Medison Customer Service Department or your local vendor.
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This document is the technical property of SAMSUNG MEDISON CO., LTD. Using this document without prior permission or for purposes other than repairs of the products of Samsung Medison without approval may be subject to legal actions.
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Table of Contents 1
Table of Contents
Chapter 1. Safety
Purpose of Use ....................................................................................................................... 2
Contraindications ............................................................................................................. 2
Safety Information .................................................................................................................. 3
Safety Symbols ................................................................................................................ 3
Symbols ........................................................................................................................... 6
LABEL .............................................................................................................................. 6
Electrical Safety ...................................................................................................................... 7
Prevention of Electric Shocks .......................................................................................... 7
ECG-related Information .................................................................................................. 10
ESD ................................................................................................................................. 10
EMI .................................................................................................................................. 11
EMC ................................................................................................................................. 12
Mechanical Safety .................................................................................................................. 20
Moving the Equipment ..................................................................................................... 20
Safety Notes .................................................................................................................... 21
Biological Safety .................................................................................................................... 24
ALARA Principle .............................................................................................................. 24
Environmental Protection ..................................................................................................... 38
Chapter 2. Introduction
Product Specifications .......................................................................................................... 2
Product Configuration ........................................................................................................... 5
The Monitor ..................................................................................................................... 7
The Control Panel ............................................................................................................ 9
The Console .................................................................................................................... 16
Peripheral Devices........................................................................................................... 18
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2 HS70A Service Manual
Probes ............................................................................................................................. 21
Accessories ..................................................................................................................... 22
Optional Functions .......................................................................................................... 22
Chapter 3. Installing the Product
Transporting ........................................................................................................................... 2
Unpacking the Product ......................................................................................................... 3
Installation Environment ....................................................................................................... 4
Installing the Product ............................................................................................................ 5
Connecting Peripherals ................................................................................................... 7
System Power ........................................................................................................................ 9
Turning the Power On ..................................................................................................... 9
Shutting Down the System .............................................................................................. 10
System Settings ..................................................................................................................... 11
General ........................................................................................................................... 12
Scan Mode ...................................................................................................................... 17
Display ............................................................................................................................. 20
Annotate .......................................................................................................................... 24
Peripheral Device Settings .............................................................................................. 29
User Defined Keys .......................................................................................................... 33
Network ........................................................................................................................... 35
DICOM Setup (optional) .................................................................................................. 37
Options ............................................................................................................................ 49
System Information ......................................................................................................... 51
Chapter 4. Product Inspection
Inspecting Functions ............................................................................................................. 2
Basic Inspections ............................................................................................................ 2
Detailed Inspections ........................................................................................................ 4
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Table of Contents 3
Chapter 5. Product Structure
Overview ................................................................................................................................. 3
System Block Diagram .......................................................................................................... 5
Basic Structure of UGEO HS70A .......................................................................................... 7
Overview .......................................................................................................................... 7
Ultrasound System Part ................................................................................................... 8
PC Part ............................................................................................................................ 9
User Interface Part .......................................................................................................... 10
AC to Power Module ........................................................................................................ 10
Ultrasound System Part ......................................................................................................... 10
PSA .................................................................................................................................. 10
Analog Control ................................................................................................................. 12
Beam Former Board ........................................................................................................ 14
CW Board ........................................................................................................................ 18
Back End Board ............................................................................................................... 21
PC Part .................................................................................................................................... 26
PC Module ....................................................................................................................... 26
Software DSC .................................................................................................................. 27
Rear Board ...................................................................................................................... 29
Power Supply ................................................................................................................... 30
User Interface Part ................................................................................................................. 32
Control Panel ................................................................................................................... 32
Docking CP Board ........................................................................................................... 33
Touch Panel .................................................................................................................... 34
Monitor ............................................................................................................................. 35
Interconnect Diagram ............................................................................................................ 36
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Chapter 6. Service Mode
Enter Installation Key ............................................................................................................ 2
System Information ............................................................................................................... 4
Windows Mode ...................................................................................................................... 5
Accessing method(Old) ................................................................................................... 5
ACCESSING METHOD(V2.01.00~) ............................................................................... 6
Admin Mode ........................................................................................................................... 7
Accessing method(Old) ................................................................................................... 7
ACCESSING METHOD(V2.01.00~) ............................................................................... 8
Admin Mode Functions ................................................................................................... 9
Adding and Deleting Options ............................................................................................... 13
Adding an Option ............................................................................................................ 14
Chapter 7. Troubleshooting
Power Issues .......................................................................................................................... 2
Power Does Not Turn On ................................................................................................ 2
Power Does Not Turn Off ................................................................................................ 2
Power Turns Off by Itself................................................................................................. 3
Monitor .................................................................................................................................... 4
Nothing Is Displayed on the Screen ................................................................................ 4
Screen is Discolored ....................................................................................................... 4
Error Messages ...................................................................................................................... 5
Error Occurs during Booting............................................................................................ 5
Image....................................................................................................................................... 6
2D Mode: There is No IMAGE ECHO or IMAGE FORMAT ............................................ 6
Lines (Noise) Appear in 2D Mode Image ........................................................................ 6
M, C, PW, CW Mode Trouble ......................................................................................... 6
Error Code .............................................................................................................................. 7
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Table of Contents 5
Chapter 8. Disassembly and Assembly
Caution .................................................................................................................................... 2
Preparation ...................................................................................................................... 2
Disassembling the Product ................................................................................................... 3
Front Cover Disassembly ................................................................................................ 3
Rear Cover Disassembly ................................................................................................. 5
Control Panel Disassembly.............................................................................................. 7
Monitor Disassembly ....................................................................................................... 8
Monitor Arm Disassembly ................................................................................................ 9
Assembling the Product ........................................................................................................ 11
Chapter 9. Probes
Probe ....................................................................................................................................... 2
Ultrasound Transmission Gel .......................................................................................... 9
Using Sheaths ................................................................................................................. 10
Probe Safety Precautions ................................................................................................ 11
Cleaning and Disinfecting the Probe ............................................................................... 13
Chapter 10. Maintenance
Product Maintenance ............................................................................................................. 2
Cleaning and disinfecting................................................................................................. 2
Air Filter Management ..................................................................................................... 4
Accuracy Checks ............................................................................................................. 5
Information Maintenance ....................................................................................................... 6
Backing up User Setting .................................................................................................. 6
Backing Up Patient Information ....................................................................................... 6
Software........................................................................................................................... 6
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Chapter 11. Service Part List
Body Cover Parts ................................................................................................................... 2
System Parts .......................................................................................................................... 8
Control Panel Parts ............................................................................................................... 12
System Cable Parts ............................................................................................................... 16
Chapter 12. Parts Renewal
Board....................................................................................................................................... 2
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Chapter 1
Chapter 1. Safety
Safety
Purpose of Use ........................................................................................................... 2
Restrictions ............................................................................................................................... 2
Safety Information ...................................................................................................... 3
Safety Symbols ......................................................................................................................... 3
LABEL ....................................................................................................................................... 6
Electrical Safety .......................................................................................................... 7
Prevention of Electric Shock ..................................................................................................... 7
ECG-Related Information ....................................................................................................... 10
ESD ......................................................................................................................................... 10
EMI .......................................................................................................................................... 11
EMC ........................................................................................................................................ 12
Mechanical Safety ..................................................................................................... 20
Moving the Equipment ............................................................................................................ 20
Safety Notes ........................................................................................................................... 21
Biological Safety ....................................................................................................... 24
ALARA Principle ..................................................................................................................... 24
Environmental Protection ........................................................................................ 38
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NOTE
For detailed information on applications and presets, please refer to the HS70A User Manual.
CAUTION
For information on the use or clinical application of this product, please refer to the HS70A User Manual.
Purpose of Use
Ultrasound diagnostic system and probes were designed for obtaining ultrasound images and analyzing human blood. The clinical applications include:
Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Restrictions
This product must not be used for ophthalmological applications, or any other use that involves the ultrasound beam passing through the eye.
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Chapter 1 Safety 1 - 3
Symbols
Description
Warning: The accompanying information must be followed to prevent serious accidents and/or damage to property.
Caution: The accompanying information helps to prevent minor accidents and/or damage to property.
Refer to the user manual.
Safety Information
Please read the following safety information before using this product. This provides explanation about the ultrasound system, the probes, the recording devices, and any of the optional equipment.
This product is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices.
Prolonged use of three-dimensional ultrasound (3D, 4D) by an unqualified individual, such as to produce a commemorative photograph or video of the fetus, may have an adverse effect on the fetus.
Please use the 3D ultrasound diagnostic imaging system for appropriate purposes only, since using it for non-diagnostic purposes such as recording videos of the fetus may adversely affect the fetus.
Safety Symbols
The International Electro Technical Commission (IEC) has established a set of symbols for medical electronic equipment, which classify a connection or warn of potential hazards. The classifications and symbols are shown below.
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Symbols
Description
Follow the user manual.
Caution: Risk of electric shock
Type BF applied part (Classification based on degree of protection against electric hazard)
Defibrillation-proof type CF applied part (Classification based on degree of protection against electric hazard)
Power on/off
Power on
Power off
Product is partially powered on
Power off for part of the product
V~
AC (alternating current) voltage source
Direct current voltage source
Dangerous voltage (Indicates dangerous voltages over 1000V AC or 1500V DC)
Protective earth (ground)
Equipotentiality
Data output port
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Chapter 1 Safety 1 - 5
Symbols
Description
Data input port
Data input/output port
Input port
Output port
Print remote output
Foot switch port
ECG port
USB port
Network port
Microphone port
Probe port
IPX 1
Dripping-proof device: Protected against vertically falling water
IPX 7
Immersion-proof device: Protected against the effects of temporary immersion in water
IPX 8
Submersion-proof device: Protected against the effects of continuous immersion in water
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Symbols
Description
Caution: Electrostatic sensitive devices (ESD)
Do not sit on the product.
Do not push the product.
Do not lean against the product.
Be mindful of the space. Do not place a finger, and or any part of your body in the space.
LABEL
Phrases containing the words ‘warning’ and/or ‘caution’ are displayed on the product’s surface
in order to protect it.
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Chapter 1 Safety 1 - 7
Electrical Safety
This equipment is categorized as a Class I device with Type BF or Type CF (ECG) applied parts.
Prevention of Electric Shock
In a hospital environment, dangerous electric current may occur as a result of the potential difference between a contactable conductive part and connected equipment in treatment rooms. The solution to the problem is consistent equipotential bonding. Medical equipment is connected with connecting leads made up of sockets which are angled to the equipotential bonding network in medical rooms.
[Figure 1.1 Equipotential Bonding]
Additional equipment connected to medical electrical equipment must comply with the pertinent IEC standards (e.g. IEC 60950/EN 60950 for data processing equipment, IEC 60601-1/EN 60601-1 for medical devices). Furthermore, all components of the product shall comply with the requirements for medical electrical systems IEC 60601-1-1/EN 60601-1-1. Any person connecting additional equipment to the signal input and output ports of medical electrical equipment must verify that the equipment complies with IEC 60601-1-1/EN 60601-1-1.
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WARNING
■ Electric shocks may result if this system, including all of its externally mounted recording and monitoring devices, is not properly grounded.
■ Never open the cover of the product. Hazardously high voltage flows through the product. All internal adjustments and replacements must be made by a qualified Samsung Medison Customer Service Department.
■ Always check the product's casing, cables, cords, and plugs for damage before using the product. Disconnect and do not use the power source if the face is cracked, chipped, torn, the housing is damaged, or if the cable is abraded.
■ Always disconnect the system from the wall outlet prior to cleaning it.
■ All patient contact devices, such as probes and ECG leads, must be
removed from the patient prior to the application of a high voltage defibrillation pulse.
■ The use of flammable anesthetic gas or oxidizing gases (N2O) should be avoided. Doing so may cause an explosion.
■ Avoid placing the system where it is likely to be difficult to operate, or disconnect.
■ Do not use HF surgical equipment with the system. Any malfunctions in the HF surgical equipment may result in burns to the patient.
■ The system must only be connected to a supply mains with protective earth to avoid risk of electric shock.
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Chapter 1 Safety 1 - 9
CAUTION
■ The system has been designed for 100-240VAC; you should select the input voltage of any connected printer and VCR. Prior to connecting a peripheral power cord, verify that the voltage indicated on the power cord matches the voltage rating of the peripheral device.
■ An isolation transformer protects the system from power surges. This continues to operate when the system is on standby.
■ Do not immerse the cable in liquids. Cables are not waterproof.
■ Make sure that the inside of the system is not exposed to or flooded
with liquids. In such cases, fire, electric shock, injury, or damage to the product may occur.
■ The auxiliary socket outlets installed on this system are rated 100-
240VAC, with a maximum total load of 150VA. Only use these outlets for supplying power to equipment that is intended to be part of the ultrasound system. Do not connect additional multiple-socket outlets or extension cords to the system.
■ Do not connect any peripheral devices not listed in this manual to the
auxiliary socket outlets of the system. It may cause an electrical hazard.
■ Do not touch SIP/SOP and the patient simultaneously. There is a risk of
electric shock from current leakage.
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WARNING
■ This product does not support ECG monitoring. Therefore, it will not recognize incompatible ECG signals.
■ Do not use the ECG electrodes of HF surgical equipment. Any malfunctions in the HF surgical equipment may result in burns to the patient.
■ Do not use ECG electrodes during cardiac pacemaker procedures or
other electrical stimulators.
■ Do not use ECG leads and electrodes in an operating room.
CAUTION
■ The level of electrical energy discharged from a system user or a patient to an ultrasound system can be significant enough to cause damage to the system or probes.
■ Always perform the pre-ESD preventive procedures before using connectors marked with the ESD warning label.
- Apply anti-static spray to carpets or linoleum.
- Use anti-static mats.
- Ground the product to the patient table or bed.
■ It is highly recommended that the user be given training on ESD-related
warning symbols and preventive procedures.
ECG-Related Information
ESD
Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air conditioning. The static shock, or ESD, is a discharge of the electrical energy buildup from a charged individual to a lesser or uncharged individual or object. An ESD occurs when an individual with an electrical energy build-up comes in to contact with conductive objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals.
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Chapter 1 Safety 1 - 11
CAUTION
In cases where EMI is causing disturbances, it may be necessary to relocate the system.
EMI
This product complies with EMI (Electromagnetic Interference) standards. However, using the system inside an electromagnetic field can lower the quality of ultrasound images and even damage the product.
If this occurs often, Samsung Medison suggests a review of the environment in which the system is being used, to identify possible sources of radiated emissions. These emissions could be from other electrical devices used within the same room or an adjacent room. Communication devices, such as cellular phones and pagers, can cause these emissions. The existence of radios, TVs, or microwave transmission equipment nearby can also cause interference.
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Emission Test
Compliance
Electromagnetic environment guidance
RF Emission
CISPR 11
Group 1
The Ultrasound System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emission
CISPR 11
Class A
The Ultrasound System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic Emission
IEC 61000-3-2
Class A
Flicker Emission
IEC 61000-3-3
Complies
EMC
Testing of the EMC (Electromagnetic Compatibility) of this system has been performed according to the international standard for EMC with medical devices (IEC 60601-1-2). This IEC standard was adopted in Europe as the European norm (EN 60601-1-2).
▐ Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment.
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Chapter 1 Safety 1 - 13
Cable
Type
Length
VGA
Shielded
Normal
RS232C
Shielded
Normal
USB
Shielded
Normal
LAN(RJ45)
Twisted pair
Any
S-Video
Shielded
Normal
Foot Switch
Shielded
2.99m
B/W printer
Unshielded Coaxial
Normal
MIC
Unshielded
Any
Printer Remote
Unshielded
Any
Audio R.L
Shielded
Normal
VHS
Shielded
Normal
ECG AUX input
Shielded
< 3m
Parallel
Shielded
Normal
CAUTION
When connecting other customer-supplied accessories to the
system, it is the user’s responsibility to ensure the electromagnetic
compatibility of the system.
WARNING
The use of cables, probes, and peripherals other than those specified, may result in increased emissions or decreased immunity of the Ultrasound System.
▐ Approved Cables, Probes and Peripherals for EMC
Cable
Cables connected to this product may affect its emissions. Refer to the table below for recommended cable types and lengths:
Probe
The image probe used with this product may affect its emission. The probe listed in
‘Chapter 5. Probes’ when used with this product, have been tested to comply with the
group1 Class A emission as required by International Standard CISPR 11.
„ Peripherals
Peripherals used with this product may affect its emissions.
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Immunity Test
IEC 60601 Test
Level
Compliance level
Electromagnetic
environment guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6KV contact
±8KV air
±6KV contact
±8KV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
±2KV
for power supply lines
±1KV
for input/output lines
±2KV
for power supply lines
±1KV
for input/output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1KV differential mode
±2KV common mode
±1KV differential mode
±2KV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
<5% Uт for 0.5 cycles (>95% dip in Uт)
40% Uт for 5 cycles (60% dip in Uт)
70% Uт for 25 cycles (30% dip in Uт)
<5% Uт for 5 s (<95% dip in Uт)
<5%Uт for 0.5 cycles (>95% dip in Uт)
40% Uт for 5 cycles (60% dip in Uт)
70% Uт for 25 cycles (30% dip in Uт)
<5%Uт for 5 s (<95% dip in Uт)
Mains power quality should be that of a typical commercial or hospital environment. If the user of this product requires continued operation during power mains interruptions, it is recommended that this product be powered from an uninterruptible power supply or a battery.
Power frequency magnetic field (50/60Hz)
IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment.
Note: Uт is the AC mains voltage, prior to application of the test level.
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Chapter 1 Safety 1 - 15
Immunity Test
IEC 60601 Test
Level
Compliance
level
Electromagnetic environment guidance
Conducted RF IEC 61000-4-6
3Vrms 150kHz
~ 80MHz
3V
Portable and mobile RF communications equipment should be used no closer to any part of the Ultrasound System, including cables, than the recommended separation distance. This is calculated using the equation applicable to the frequency of the transmitter.
Recommended separation distance
80MHz to 800MHz 800MHz to 2.5GHz
Radiated RF IEC 61000-4-3
3V/m 80MHz
~ 2.5GHz
3V/m
Where P is the transmitter’s maximum output
power rating in watts (W) according to the transmitter’s manufacturer, and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
a
should be less than the compliance level in
each frequency range.b Interference may occur in the vicinity of
equipment marked with the following symbol:
Note 1) At 80MHz and 800MHz, the higher frequency range applies. Note 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio, (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be predicted with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength, in the location in which the Ultrasound System is used, exceeds the applicable RF compliance level above, the Ultrasound System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Ultrasound System or using a shielded location with a higher RF shielding effectiveness and filter attenuation.
b
IOver the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
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Rated maximum
output power of
transmitter
W
Separation distance, according to frequency of transmitter m
150kHz ~ 80MHz
80MHz ~ 800MHz
800MHz ~ 2.5GHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W), according to the transmitter’s manufacturer.
NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
▐ Recommended Separation Distances between This Product and RF Communications Equipment
This product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product. These distances are recommended below, according to the maximum output power of the communications equipment.
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Chapter 1 Safety 1 - 17
CAUTION
If the system is connected to other customer-supplied equipment, such as a local area network (LAN) or a remote printer, Samsung Medison cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic phenomena.
▐ Electromagnetic Environment – Guidance
It is recommended to use ultrasound systems in shielded locations offering RF shielding effectiveness, with shielded cables. Field strengths outside the location shielded from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than 3V/m.
It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification.
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Imaging Mode
ESD1
RF2
Power Line3
2D
Change of operating mode, system settings, or system reset.
Brief flashes in the displayed or recorded image.
For sector imaging probes, white radial bands or flashes in the centerlines of the image.
For linear imaging probes, white vertical bands, sometimes more pronounced on the sides of the image.
White dots, dashes, diagonal lines, or diagonal lines near the center of the image.
M
Increase in the image background noise or white M mode lines.
White dots, dashes, diagonal lines, or increase in image background noise.
Color
Color flashes, radial or vertical bands, increase in background noise, or changes in color image.
Color flashes, dots, dashes, or changes in the color noise level.
Doppler
Horizontal lines in the spectral display or tones, abnormal noise in the audio, or both.
Vertical lines in the spectral display, popping type noises in the audio, or both.
1. ESD caused by discharging of electric charge build-up on insulated surfaces or persons.
2. RF energy from RF transmitting equipment such as portable phones, hand-held radios, wireless devices, commercial radio and TV, and so on.
3. Conducted interference on power lines or connected cables caused by other equipment, such as switching power supplies, electrical controls, and natural phenomena such as lightning.
▐Avoiding Electromagnetic Interference
Typical interference on ultrasound imaging systems varies depending on electromagnetic phenomena. Please refer to the following table:
A medical device can either generate or receive electromagnetic interference. The EMC standards describe tests for both emitted and received interference.
Samsung Medison ultrasound systems do not generate interference in excess of the referenced standards.
The Ultrasound System is designed to receive signals at radio frequency and is therefore
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Chapter 1 Safety 1 - 19
susceptible to interference generated by RF energy sources. Examples of other sources of interference are medical devices, information technology products, and radio and television transmission towers. Tracing the source of radiated interference can be a difficult task. Customers should consider the following in an attempt to locate the source:
- Is the interference intermittent or constant?
- Does the interference show up only with one transducer operating at the same
frequency or with several transducers?
- Do two different transducers operating at the same frequency have the same problem?
- Is the interference present if the system is moved to a different location in the facility?
The answers to these questions will help to determine if the problem resides with the system or the scanning environment. After you answer this question, contact your local Samsung Medison customer service representative.
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WARNING
The product weighs more than 100kg. Be extra careful when transporting it. Careless transportation of the product may result in product damage or personal injury.
Mechanical Safety
Moving the Equipment
Before transporting the product, check that the wheel brakes are unlocked. Also, make
sure to retract the monitor arm completely, so that it is secured in a stationary position.
Always use the handles at the back of the console and move the product slowly.
This product is designed to resist shocks. However, excessive shock, for example – if the product falls over, may cause serious damage.
If the product does not work properly after transfer, please contact the Samsung Medison Service Department.
▐The Brakes
You can use the brakes to control the movement of the product. The brakes are mounted on each wheel of the main body with interlinked on/off buttons. This is how you engage or release the brakes:
- Engaged: To engage the brakes, press the On button with your foot. The Off button will rise.
- Released: To release the brakes, press the Off button with your foot. The On button will rise.
We recommend that you lock the brakes when using the product.
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WARNING
Be aware of the castors, especially when moving the system. Samsung Medison recommends that you exercise caution when moving the product up or down ramps.
CAUTION
■ Do not press the control panel excessively.
■ Never attempt to modify the product in any way.
■ Check the operational safety when using the product after a prolonged
break in service.
■ Make sure that other objects, such as pieces of metal, do not enter the system.
■ Do not block the ventilation slots.
■ Do not pull on the power cord to unplug it. Doing so can damage the
cord and cause short-circuiting and cord snapping. Always unplug by pulling on the plug itself.
■ Excessive bending or twisting of cables, or parts that are applied to the
patient, may cause failure or intermittent operation of the system.
■ Improper cleaning or sterilization of parts that are applied to the patient may cause permanent damage.
■ Servicing the product, including repairs and the replacement of parts, must be done by qualified Samsung Medison service personnel. Assuming that the product is used in accordance with the guidelines contained in this manual and maintained by qualified service personnel, the expected service life of the product is approximately 7 years.
▐Precautions on Ramps
Always make sure that the control panel is facing the direction of movement.
When moving the product down a ramp or resting it temporarily on a ramp, the product may tilt over even with the brakes on depending on the direction the product is facing. Do not leave the product on ramps.
Safety Notes
For detailed information on cleaning and disinfecting the product, refer to ‘Chapter 4. Maintenance‘.
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CAUTION
■ Do not press on the control panel with excessive force or lean against it.
■ Do not sit on the control panel or apply too much pressure to it.
▐Monitor Safety Caution
When adjusting the height or position of the monitor, be careful of the space in the middle of the monitor arm. Having your fingers, or other body parts, caught in it may result in injury.
[Figure 1.2 Monitor Safety Caution]
▐Control Panel Caution
When adjusting the control panel’s height or position, be mindful of the space between the
panel and the lift. Having your fingers, or other body parts, caught in it may result in injury.
[Figure 1.3 Control Panel Caution]
When using the handle of the control panel, be mindful of the space between the handle and the keyboard. The keyboard may pop up and hit your hand.
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[Figure 1.4 Handle Caution]
Chapter 1 Safety 1 - 23
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WARNING
■ Ultrasound waves may have damaging effects on cells and, therefore, may be harmful to the patient. If there is no medical benefit, minimize the exposure time and maintain the ultrasound wave output level at low. Please refer to the ALARA principle.
■ Do not use the system if an error message appears on the video display indicating that a hazardous condition exists. Note the error code, turn off the power to the system, and call Samsung Medison customer service department.
■ Do not use a system that exhibits erratic or inconsistent functioning. Discontinuities in the scanning sequence are indicative of a hardware failure that should be corrected before use.
■ The system limits the maximum contact temperature to 43 degrees Celsius, and the ultrasonic wave output observes American FDA regulations.
Biological Safety
For safety instructions concerning probes and biopsies, refer to HS70A User Manual.
ALARA Principle
Guidance for the use of diagnostic ultrasound is defined by the ”(As Low As Reasonably Achievable) (ALARA) principle. The decision as to what is reasonable has been left to the judgment and insight of qualified personnel. No set of rules can be formulated that would be sufficiently complete to dictate the correct response to every circumstance. By keeping ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize ultrasonic bioeffects.
Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s
responsibility to control the total energy transmitted into the patient. The sonographer must reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, the Ultrasound System provides controls that can be manipulated during the exam to optimize the results.
The ability of the user to abide by the ALARA principle is important. Advances in diagnostic ultrasound, not only in the technology but also in its applications, have resulted in the need for increased and improved information to guide the user. The output indices are designed to provide that important information.
There are a number of variables, which affect the way in which the output display indices can be used to implement the ALARA principle. These variables include mass, body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially useful variable, because the user controls it. The ability to limit the index values over time supports the ALARA principle.
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▐Applying ALARA
The system imaging mode used depends upon the information needed. 2D-mode and M-mode imaging provide anatomical information, while Doppler, Power, and Color imaging provide information about blood flow. Scanned modes, like 2D-mode, Power, or Color, disperse or scatter the ultrasonic energy over an area, while an unscanned mode, like M-mode or Doppler, concentrate the ultrasonic energy. Understanding the nature of the imaging mode being used allows the sonographer to apply the ALARA principle with informed judgment. The probe frequency, system set-up values, scanning techniques, and operator experience aid the sonographer in meeting the ALARA principle. The decision as to the amount of acoustic output is, in the final analysis, up to the system operator. This decision must be based on the following factors: type of patient, type of exam, patient history, ease or difficulty of obtaining diagnostically useful information, and the potential localized heating of the patient due to probe surface temperatures. Prudent use of the system occurs when patient exposure is limited to the lowest index reading for the shortest amount of time necessary to achieve acceptable diagnostic results. Although a high index reading does not mean that a biological effect is actually occurring, it should be taken seriously. Every effort should be made to reduce the possible effects of a high index reading. Limiting exposure time is an effective way to accomplish this goal. There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA and can be divided into three categories: direct, indirect, and receiver control.
▐Direct Controls
Application selection and the output intensity control directly affect acoustic intensity. There are different ranges of allowable intensity or output depending on your selection. Selecting the correct range of acoustic intensity for the application is one of the first things required during any exam. For example, peripheral vascular intensity levels are not recommended for fetal exams. Some systems automatically select the proper range for a particular procedure, while others require manual selection. Ultimately, the user bears the responsibility for proper clinical use. Samsung Medison systems provide both automatic and user-definable settings. Output has direct impact on acoustic intensity. Once the application has been established, the output control can be used to increase or decrease the output intensity. The output control allows you to select intensity levels less than the defined maximum. Prudent use dictates that you select the lowest output intensity consistent with good image quality.
▐Indirect Controls
The indirect controls are those that have an indirect effect on acoustic intensity. These controls affect
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imaging mode, pulse repetition frequency, focus depth, pulse length, and probe selection. The choice of imaging mode determines the nature of the ultrasound beam. 2D-mode is a scanning mode, Doppler is a stationary or unscanned mode. A stationary ultrasound beam concentrates energy on a single location. A moving or scanned ultrasound beam disperses the energy over a wide area and the beam is only concentrated on a given area for a fraction of the time that is necessary in unscanned mode. Pulse repetition frequency or rate refers to the number of ultrasound bursts of energy over a specific period of time. The higher the pulse repetition frequency, the more pulses of energy in a given period of time. Several controls affect pulse repetition frequency: focal depth, display depth, sample volume depth, color sensitivity, number of focal zones, and sector width controls. The focus of the ultrasound beam affects the image resolution. To maintain or increase resolution at a different focus requires a variation of output over the focal zone. This variation of output is a function of system optimization. Different exams require different focal depths. Setting the focus to the proper depth improves the resolution of the structure of interest. Pulse length is the time during which the ultrasonic burst is turned on. The longer the pulse, the greater the time-average intensity value. The greater the time-average intensity, the greater the likelihood of temperature increase and cavitations. Pulse length, burst length or pulse duration is the output pulse duration in pulsed Doppler. Increasing the Doppler sample volume, increases the pulse length. Probe selection affects intensity indirectly. Tissue attenuation changes with frequency. The higher the probe operating frequency, the greater the attenuation of the ultrasonic energy. Higher probe operating frequencies require higher output intensity to scan at an increased depth. To scan deeper at the same output intensity, a lower probe frequency is required. Using more gain and output beyond a point, without corresponding increases in image quality, can mean that a lower frequency probe is needed.
Receiver Controls
Receiver controls are used by the operator to improve image quality. These controls have no effect on output. Receiver controls only affect how the ultrasound echo is received. These controls include gain, TGC, dynamic range, and image processing. The important thing to remember, relative to output, is that receiver controls should be optimized before increasing output. For example; before increasing output, optimize gain to improve image quality.
▐Additional Considerations
Ensure that scanning time is kept to a minimum, and ensure that only medically required scanning is performed. Never compromise quality by rushing through an exam. A poor exam will require a follow-
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up, which ultimately increases the time. Diagnostic ultrasound is an important tool in medicine, and, like any tool, should be used efficiently and effectively.
▐Output Display Features
The system output display comprises two basic indices: a mechanical index and a thermal index. The thermal index consists of the following indices: soft tissue (TIs), bone (TIb) and cranial bone (TIc). One of these three thermal indices will be displayed at all times. Which one depends upon the system’s default setting or user choice, depending upon the application at hand.
The mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of 0.1. The thermal index consists of the three indices, and only one of these is displayed at any one time. Each probe application has a default selection that is appropriate for that combination. The TIb or TIs is continuously displayed over the range of 0.0 to the maximum output, based on the probe and application, in increments of 0.1.
The application-specific nature of the default setting is also an important factor of index behavior. The default setting is a system control state, which is preset by the manufacturer or the operator. The system has default index settings for the probe application. The default settings are invoked automatically by the Ultrasound System when power is turned on, new patient data is entered into the system database, or a change in application takes place. The decision as to which of the three thermal indices to display should be based on the following criteria:
Appropriate index for the application: TIs is used for imaging soft tissue; and TIb for a focus at or near bone.Some factors might create artificially high or low thermal index readings, e.g. the presence of fluid or bone, or the flow of blood. A highly attenuating tissue path, for example, will cause the potential for local zone heating to be less than the thermal index displays.
Scanned modes versus unscanned modes of operation affect the thermal index. For scanned modes, heating tends to be near the surface; for unscanned modes, the potential for heating tends to be deeper in the focal zone.
Always limit ultrasound exposure time but do not rush the exam. Ensure that the indices are kept to a minimum and that exposure time is limited without compromising diagnostic sensitivity.
Mechanical Index (MI) Display
Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with the type of tissue. The potential for mechanical biological effects varies with peak pressure and ultrasound frequency. The MI
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accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring. However, there is no specific MI value that means that a mechanical bioeffect will actually occur. The MI should be used as a guide for implementing the ALARA principle.
Thermal Index (TI) Display
The TI informs the user about the potential for temperature increase occurring at the body surface, within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of the temperature increase in specific body tissues. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, mode of operation, etc. The TI should be used as a guide for implementing the ALARA principle.
The bone thermal index (TIb) informs the user about potential heating at or near the focus, after the ultrasound beam has passed through soft tissue or fluid, for example, at or near second or third trimester fetal bone. The cranial bone thermal index (TIc) informs the user about the potential heating of bone at or near the surface of, for example, cranial bone. The soft tissue thermal index (TIs) informs the user about the potential for heating within soft homogeneous tissue. TIc is displayed when you select a trans-cranial application.
You can select TI Display in Utility > Setup > Display > Display.
Precision and Accuracy of Mechanical and Thermal Indices Displays
The mechanical and thermal indices on the system are precise to 0.1 units. The MI and TI display accuracy estimates for the system are given in the Acoustic Output Tables manual. These accuracy estimates are based on the various range of probes and systems, inherent acoustic output modeling errors, and measurement variation, as described below.
The displayed values should be interpreted as relative information to help the system operator achieve the ALARA principle through prudent use of the system. The values should not be interpreted as actual physical values from investigated tissue or organs. The initial data that is used to support the output display is derived from laboratory measurements based on the AIUM measurement standard. The measurements are then put into algorithms for calculating the displayed output values.
Many of the assumptions used in the process of measurement and calculation are conservative in nature. Over-estimation of actual in situ exposure, for the vast majority of tissue paths, is built into
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the measurement and calculation process. For example, the measured water tank values are derated using a conservative, industry standard, attenuation coefficient of 0.3dB/cm-MHz.
Conservative values for tissue characteristics were selected for use in the TI models. Conservative values for tissue or bone absorption rates, blood perfusion rates, blood heat capacity, and tissue thermal conductivity were selected.
A steady state temperature rise is assumed in the industry standard TI models, and the assumption is made that the ultrasound probe is held steady in one position long enough for a steady state to be reached.
A number of factors are considered when estimating the accuracy of display values: hardware variations, algorithm accuracy estimation and measurement variation. Variation among probes and systems is a significant factor. Probe variability results from piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens focusing parameter variations. Differences in the system pulse voltage control and efficiencies are also a contributor to variability. There are inherent uncertainties in the algorithms used for estimating acoustic output values over the range of possible system operating conditions and pulse voltages. Inaccuracies in laboratory measurements are related to differences in hydrophone calibration and performance, positioning, alignment and digitization tolerances, as well as variation among test operators.
The conservative assumptions of the output estimation algorithms of linear propagation, at all depths, through a 0.3dB/cm-MHz attenuated medium are not taken into account in calculation of the accuracy estimate displayed. Neither linear propagation, nor uniform attenuation at the
0.3dB/cm-MHz rate, occur in water tank measurements or in most tissue paths in the body. In the body, different tissues and organs have dissimilar attenuation characteristics. In water, there is almost no attenuation. In the body, and particularly in water tank measurements, non-linear propagation and saturation losses occur as pulse voltages increase.
The display accuracy estimates take into account the varying ranges of probes and systems, inherent acoustic output modeling errors, and measurement variations. Display accuracy estimates are not based on errors in, or caused by measuring according to, the AIUM measurement standards. They are also independent of the effects of non-linear loss on the measured values.
▐Control Effect - Control Affecting the indices
As various system controls are adjusted, the TI and MI values may change. This will be most apparent as the POWER control is adjusted; however, other system controls will affect the on-screen output
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values.
Power
Power controls the system acoustic output. Two real-time output values are on the screen: a TI and an MI. They change as the system responds to POWER adjustments. In combined modes, such as simultaneous Color, 2D-mode and pulsed Doppler, the individual modes each add to the total TI. One mode will be the dominant contributor to this total. The displayed MI will be from the mode with the largest peak pressure.
▐2D-mode Controls
2D-Mode Size
Narrowing the sector angle may increase the frame rate. This action will increase the TI. Pulse voltage may be automatically adjusted down via software controls to keep the TI below the system maximums. A decrease in pulse voltage will decrease the MI.
Zoom
Increasing the zoom magnification may increase the frame rate. This action will increase the TI. The number of focal zones may also increase automatically to improve resolution. This action may change the MI, since the peak intensity can occur at a different depth.
Persistence
A lower persistence will decrease the TI. Pulse voltage may be automatically increased. An increase in pulse voltage will increase the MI.
Focal no.
More focal zones may change both the TI and MI by changing the frame rate or focal depth automatically. Lower frame rates decrease the TI. The MI displayed will correspond to the zone with the largest peak intensity.
Focus
Changing the focal depth will change the MI. Generally, higher MI values will occur when the focal depth is near the natural focus of the transducer.
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▐Color and Power Controls
Color Sensitivity
Increasing the color sensitivity may increase the TI. More time is spent scanning for color images. Color pulses are the dominant pulse type in this mode.
Color Sector Width
Narrower color sector width will increase color frame rate and the TI will increase. The system may automatically decrease pulse voltage to stay below the system maximum. A decrease in pulse voltage will decrease the MI. If pulsed Doppler is also enabled, then pulsed Doppler will remain as the primary mode and the TI change will be small.
Color Sector Depth
Deeper color sector depth may automatically decrease color frame rate or change color focal zone or color pulse length. The TI will change due to the combination of these effects. Generally, the TI
Chapter 1 Safety 1 - 31
will decrease with increased color sector depth. MI will correspond to the peak intensity of the dominant pulse type, which is a color pulse. However, if pulsed Doppler is also enabled then pulsed Doppler will remain the dominant mode and the TI change will be small.
Scale
Using the SCALE control to increase the color velocity range may increase the TI. The system will automatically adjust pulse voltage to stay below the system maximums. A decrease in pulse voltage will also decrease MI.
Sec Width
A narrower 2D-mode sector width in Color imaging will increase color frame rate. The TI will increase and the MI will not change. If pulsed Doppler is also enabled, then pulsed Doppler will remain as the primary mode and the TI change will be small.
▐M Mode and Doppler Controls
Speed
M-Mode and Doppler sweep speed adjustments will not affect the MI. When M-Mode sweep speed changes, TI changes.
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Simultaneous and Update Methods
Use of combination modes affects both the TI and MI through the combination of pulse types. During simultaneous mode, the TI is additive. During auto-update and duplex, the TI will display the dominant pulse type. The displayed MI will be from the mode with the largest peak pressure.
Sample Volume Depth
When Doppler sample volume depth is increased, the Doppler PRF may automatically decrease. A decrease in PRF will decrease the TI. The system may also automatically decrease the pulse voltage to remain below the system maximum. A decrease in pulse voltage will decrease the MI.
▐ Doppler, CW, M-Mode, and Color Imaging Controls
When a new imaging mode is selected, both the TI and the MI will change to default settings. Each mode has a corresponding pulse repetition frequency and maximum intensity point. In combined or simultaneous modes, the TI is the sum of the contribution from the modes enabled and the MI is for the focal zone and mode with the largest derated intensity. If a mode is turned off and then reselected, the system will return to the previously selected settings.
Probes
Each probe model available has unique specifications for contact area, beam shape, and center frequency. Defaults are initialized when you select a probe. Factory defaults vary with probe, application, and selected mode. Defaults have been chosen below the FDA limits for intended use.
Depth
An increase in 2D-mode depth will automatically decrease the 2D-mode frame rate. This would decrease the TI. The system may also automatically choose a deeper 2D-mode focal depth. A change of focal depth may change the MI. The MI displayed is that of the zone with the largest peak intensity.
Application
Acoustic output defaults are set when you select an application. Factory defaults vary with probe, application, and mode. Defaults have been chosen below the FDA limits for intended
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use.
▐Related Guidance Documents
For more information about ultrasonic bioeffects and related topics refer to the following:
- AIUM Report, January 28, 1993, “Bioeffects and Safety of Diagnostic Ultrasound”
- Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept.
1998: Vol. 7, No. 9 Supplement
- Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM, NEMA.
1998)
- Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 1998)
- Second Edition of the AIUM Output Display Standard Brochure, Dated March 10, 1994. (A copy
of this document is shipped with each system.)
- Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. FDA. September 1997. FDA.
- Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA. 1998)
- WFUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on Thermal and Non-Thermal Mechanisms for Biological Effects of Ultrasound, Ultrasound in Medicine and Biology, 1998: Vol. 24, Supplement1.
▐Acoustic Output and Measurement
Since the first usage of diagnostic ultrasound, the possible human biological effects (bioeffects) of ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared by its Bioeffects Committee (Bioeffect Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol.7, No.9 Supplement), sometimes referred to as the Stowe Report, which reviewed available data on possible effects of ultrasound exposure. Another report, “Bioeffects and Safety of Diagnostic Ultrasound,” dated 28th January, 1993, provides more up to date information.
The acoustic output for this system has been measured and calculated in accordance with the
December 1985 “510 (K) Guide for Measuring and Reporting Acoustic Output of Diagnostic
Ultrasound Medical Devices,” except that the hydrophone meets the requirements of “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD 2-1992).
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)23.0( alf
e
)069.0( lf
e
▐In Situ, De-rated, and Water Value Intensities
All intensity parameters are measured in water. Since water does not absorb acoustic energy, these water measurements represent a worst case value. Biological tissue does absorb acoustic energy. The true value of the intensity at any point depends on the amount and type of tissue and the frequency of the ultrasound that passes through the tissue. The intensity value in the tissue, In Situ has been estimated using the following formula:
In Situ = Water where: In Situ = In Situ Intensity Value Water = Water Value Intensity e = 2.7183 a = Attenuation Factor Tissue a(dB/cm-MHz) Brain .53 Heart .66 Kidney .79 Liver .43 Muscle .55
l = skin line to measurement depth (cm) f = Center frequency of the transducer/system/mode combination (MHz)
Since the ultrasonic path during an examination is likely to pass through varying lengths and types of tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used for general reporting purposes. Therefore, the In Situvalue which is commonly reported uses the formula:
In Situ (derated) = Water
Since this value is not the true in situ intensity, the term “de-rated” is used. The maximum derated and the maximum water values do not always occur at the same operating condition. Therefore, the reported maximum water and derated values may not be related to the In Situ (derated) formula. For example, a multi-zone array transducer that has maximum water value intensities in its deepest zone: The same transducer may have its largest derated intensity in one of its shallowest focal zones.
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▐Acoustic Output and Measurement
The terms and symbols used in the acoustic output tables are defined in the following paragraphs.
ISPTA.3 The derated spatial-peak temporal-average intensity (Milliwatts per square centimeter). ISPPA.3 The derated spatial-peak pulse-average intensity(watts per square centimeter). The
value of IPA.3 at the position of global maximum MI (IPA.3@MI) may be reported instead of ISPPA.3 if the global maximum MI is reported.
MI The Mechanical Index. The value of MI at the position of ISPPA.3, ([email protected]) may be
reported instead of MI (global maximum value) if ISPPA.3 is 190W/cm2.
Pr.3 The derated peak rarefactional pressure (megapascals) associated with the transmit
pattern giving rise to the reported MI value.
WO Ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, WO is
the total time-average power; For operating conditions subject to reporting under ISPPA.3, WO is the ultrasonic power associated with the transmit pattern, giving rise to the value reported under ISPPA.3.
Fc Center frequency (MHz). For MI and ISPPA.3, Fc is the center frequency associated
with the transmit pattern, giving rise to the global maximum value of the respective parameter. For ISPTA.3, for combined modes involving beam types of unequal center frequency, Fc is defined as the overall ranges of center frequencies of the respective transmit patterns.
ZSP The axial distance at which the reported parameter is measured (centimeters). x-6,y-6 These are respectively the in-plane (azimuth) and out-of-plane (elevation) -6 dimensions in
the x-y plane where ZSP is found (centimeters).
PD The pulse duration (microseconds) associated with the transmit pattern, giving rise to the
reported value of the respective parameter.
PRF The pulse repetition frequency (Hz) associated with the transmit pattern, giving rise to
the reported value of the respective parameter.
EBD The entrance beam dimensions for the azimuth and elevation planes (centimeters). EDS The entrance dimensions of the scan for the azimuth and elevation planes (centimeters).
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Quantity
Precision
Total Uncertainty
PII.3 (derated pulse intensity integral)
3.2 %
+21 % to - 24 %
Wo (acoustic power)
6.2 %
+/- 19 %
Pr.3 (derated rarefaction pressure)
5.4 %
+/- 15 %
Fc (center frequency)
< 1 %
+/- 4.5 %
▐Acoustic Measurement Precision and Uncertainty
The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are described below.
Systematic Uncertainties
For the pulse intensity integral, derated rarefaction pressure, Pr.3, Center frequency and pulse duration, the analysis includes considerations of the effects on accuracy of:
Hydrophone calibration drift or errors. Hydrophone / Amp frequency response. Spatial averaging. Alignment errors. Voltage measurement accuracy, including.
- Oscilloscope vertical accuracy.
- Oscilloscope offset accuracy.
- Oscilloscope clock accuracy.
- Oscilloscope Digitization rates.
- Noise.
The systematic uncertainties of acoustic power measurements using a radiation force are measured through the use of calibrated NIST acoustic power sources. We also refer to a September 1993 analysis done by a working group of the IEC technical committee 87 and prepared by K. Beissner, as a first supplement to IEC publication 1161. The document includes analysis and discussion of the sources of error/measurement effects due to:
Balance system calibration. Absorbing (or reflecting) target suspension mechanisms. Linearity of the balance system. Extrapolation to the moment of switching the ultrasonic transducer (compensation for ringing and thermal drift).
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Target imperfections. Absorbing (reflecting ) target geometry and finite target size. Target misalignment. Ultrasonic transducer misalignment. Water temperature. Ultrasonic attenuation and acoustic streaming. Coupling or shielding foil properties. Plane-wave assumption. Environmental influences. Excitation voltage measurement. Ultrasonic transducer temperature.
Effects due to nonlinear propagation and saturation loss. The overall findings of the analysis give a rough Acoustic Power accuracy figure of ±10% for the frequency range of 1 – 10 MHz.
▐Training
The users of this ultrasound system must familiarize themselves with the ultrasound system to optimize the performance of the device and to detect possible malfunctions. It is recommended that all users receive proper training before using the device. You can receive training on the use of the product from the Samsung Medison service department, or any of the customer support centers worldwide.
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CAUTION
■ For disposing of the system or accessories that have come to the end of
their service life, contact the vendor or follow appropriate disposal procedures.
■ You are responsible for complying with the relevant regulations for
disposing of wastes.
■ The lithium ion battery used in the product must be replaced by a Samsung Medison service engineer or an authorized dealer.
Environmental Protection
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Chapter 2
Chapter 2 Introduction
Introduction
Specifications ................................................................................ 2
Product Configuration .................................................................. 5
Monitor ............................................................................................................. 7
Control Panel ................................................................................................... 9
Console .......................................................................................................... 17
Peripheral Devices ......................................................................................... 19
Probes............................................................................................................ 22
Accessories .................................................................................................... 23
Optional Functions ......................................................................................... 24
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Physical
Dimensions
Height: 1,430 – 1,710mm (with monitor) Width: 557mm Depth: 791 – 860mm Weight: 99.4kg (with monitor) Weight: Approx. 124kg (with Safe Working Load)
Imaging Modes
2D Mode M Mode Color Doppler Pulsed Wave (PW) Spectral Doppler Continuous Wave (CW) Spectral Doppler Tissue Doppler Imaging (TDI) Tissue Doppler Wave (TDW) Power Doppler (PD) Directional Power Doppler (S-Flow) Color M Mode Anatomical M Mode 3D imaging Mode 4D imaging Mode ElastoScan Mode
Gray Scale
256 (8 bits)
Focusing
Transmit focusing, maximum of eight points (four points simultaneously selectable) Digital dynamic receive focusing (continuous)
Probes
(Type BF/IPX7)
Linear Array
L3-12A, LA3-16A, LA3-16AI, LA2-9A, LA4-18B, LM4-15B
Convex
CA1-7A, CA2-8A, CF4-9, CA3-10A, CA2-9A
Endocavity
E3-12A, VR5-9, EA2-11B
Phased Array
PA3-8B, PE2-4, PA4-12B, PA1-5A
3D
CV1-8A, LV3-14A, V5-9
CW
CW4.0, CW6.0, DP2B, DP8B
TEE
MMPT3-7
Probe
Connections
Four Active Probe Ports (include one CW probe port) Five Active Probe Ports for option (include one CW probe port)
Specifications
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Chapter 2. Introduction 2 - 3
Monitor
Main Monitor
23 inch Full HD LCD monitor (LED Backlight unit, hereafter referred to as “LCD monitor”)
Touch Screen Monitor
10.1 inch LCD monitor (LED Backlight unit, hereafter referred to as “LCD monitor”)
ECG
USB Type (Type CF)
Rear Panel
Input/Output Connections
Audio out Microphone in External Trigger out External monitor DVI-I Network USB S-VHS Video out Composite Video out
Image Storage
Maximum 12,700 frames for Cine memory Maximum 8,192 lines for Loop memory Image filing system
Application
Obstetrics, Gynecology, Urology, Abdomen, Vascular, Small Part, MSK, Pediatric, Cardiac, TCD, Intraoperative
Electrical
Parameters
100-240V~, 1100VA, 50/60Hz
Measurement
Packages
OB, Gynecology, Cardiac, Vascular, Fetal Heart, Urology, Abdomen, Small Parts, MSK, TCD, Pediatric Hips
* Refer to ‘Chapter 9. Measurements and Calculations’ for additional information
Signal
Processing
(Pre-Processing)
TGC Control (Digital/Slider) Mode-independent gain control Acoustic power control (adjustable) Dynamic aperture Dynamic apodization Dynamic range control (adjustable) Image view area control M-mode sweep speed control
Signal
Processing
(Post-
Processing)
Frame average Edge enhancement/blurring Gamma-scale windowing Image orientation (left/right, up/down, and rotation) White on black/black on white Zoom
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Measurement
Trackball operation of multiple cursors 2D mode: Linear measurements and area measurements using elliptical
approximation or trace M mode: Continuous readout of distance, time, and slope rate Doppler mode: Velocity and trace
Auxiliary
USB Video Printer USB to RS-232 Serial Cable Foot Switch (IPX8) USB HDD Monitor
User Interface
English, German, French, Spanish, Italian, Russian, Chinese
Pressure Limits
Operating: 700 – 1,060hPa Storage: 700 – 1,060hPa
Humidity Limits
Operating: 30 – 75% Storage & Shipping: 20 – 90%
Temperature
Limits
Operating: 10 – 35C Storage & Shipping: -25 – 60C
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Chapter 2. Introduction 2 - 5
[Figure 2.1 Front of the HS70A]
Monitor Monitor arm DVD drive Speaker Control panel Probe holder Keyboard Lift USB port CW probe port Probe port Air filter Brake Wheels
Touch panel Gel Warmer (Option)
Product Configuration
This product consists of the monitor, the control panel, the console, the peripheral devices, and the probes.
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[Figure 2.2 Back of the HS70A]
① Handle ② Storage compartments ③ Ventilation ④ Rear panel ⑤ Cable holder ⑥ Power connection part ⑦ ID Label
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Chapter 2. Introduction 2 - 7
NOTE
The Ez Exam+ menu can be set up in Ez Exam+ Setup. For details about Ez Exam+ Setup, please refer to ‘Chapter 3. Utilities’.
Monitor
Ultrasound images and other information are displayed on the color LCD monitor.
▌ Screen Layout
The monitor displays ultrasound images, operation menus and a variety of other information. As shown in the image below, the screen consists of ① Title Area, ② Preset Change and Ez Exam+ Area ③ Image Area, ④ Thumbnail Area, ⑤ User Information Area, and ⑥ User Defined Key Area.
[Figure 2.3 Monitor Display]
① Title Area
Displays patient name, hospital name, application, frame rate and depth, probe information, acoustic output information, and date and time.
② Preset Change and Ez Exam+ Area
Displays Preset Change. You can quickly change the preset of a probe. If you are using Ez Exam+, the Ez Exam+ menu will be displayed.
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NOTE
For information on User Key Setup, please refer to ‘Chapter 3. Utilities’.
TIP
Principles of Operation of the Diagnostic Ultrasound System
Medical ultrasound images are created when the computer’s digital memory converts the high-frequency wave signals that are transmitted and received by the probe.
As ultrasound waves propagate through the human body, they generate reflected signals whenever they encounter a change in density. For example, reflected signals are generated when signals pass from fatty tissues to muscle tissues. Reflected signals return to the probe where they are converted into electronic signals. The reflected signals are amplified and processed by analog and digital circuits that have filters for various frequencies and response time options. Then they are again converted into high-frequency electronic signals, and saved as a series of digital image signals. The monitor displays the image signals stored on the storage device in real time.
The entire process of transmitting, receiving, and processing signals is controlled by the computer.
③ Image Area
Displays ultrasound images, TGC, image information, annotation, and measurement information are also displayed.
④ Thumbnail Area
Up to five saved images are displayed. (Save by pressing the Save button.) When you save Single screens, up to 5 images are shown in a list; for Quad screens, up to 16 images are shown. Clicking with the pointer will enlarge the selected thumbnail in the Image area. At the top of the Thumbnail area, you can see the total number of images saved.
⑤ User Information Area
Information that is useful to the user, such as current system status, image information, selectable items, etc., is displayed.
⑥ User Defined Key Area
Settings for User Defined Keys, including the positions of Set and Exit, are displayed. You can change the setting of each button in Setup > User Defined Key.
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Control Panel
The system can be controlled by using the control panel.
Chapter 2. Introduction 2 - 9
[Figure 2.4 Control Panel]
The control panel consists of a keyboard, soft menus, buttons, dials, dial-buttons, a slider, and a trackball.
The dial-button can be used both as a dial and a button.
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On/Off
Button
Turns the system on/off.
2D
Dial-button
– Button: Starts 2D mode. – Dial: Adjusts the 2D gain.
M/x
Dial-button
– Button: Starts or ends M mode. – Dial: Adjusts M gain. Also, turning this dial-button when in
3D View rotates the image along the x-axis.
PW/y
Dial-button
– Button: Starts or ends PW Spectral Doppler mode. – Dial: Adjusts the PW gain. Also, turning this dial-button,
when in 3D View rotates the image along the y-axis.
C/z
Dial-button
– Button: Starts or ends Color Doppler mode. – Dial: Adjusts the C gain. Also, turning this dial-button when
in 3D View rotates the image along the z-axis.
CW
Button
– Button: Starts or ends CW Spectral Doppler mode. – Dial: Adjusts the CW gain.
PD
Button
Starts or ends Power Doppler mode.
3D/4D
Button
Starts or ends 3D/4D modes.
Angle
Dial-button
Adjusts the angle of the sample volume in Spectral Doppler mode. It is also used to adjust the BodyMarker’s probe cursor or indicator angle.
Depth
Switch
Adjusts the scanning depth of the image.
Focus
Switch
Changes location and number of focus on the target location you wish to study.
Zoom
Dial-button
You can magnify an image.
Q Scan
Button
Press this button to turn the Quick Scan function on. The ‘Q
Scan’ mark will appear at the top of an image.
Freeze
Button
Pauses/resumes scanning.
P 1–4
Button
Stands for ‘Peripheral Key.’ This button allows users to select a
function to apply to the button. The function of each button can be set in Setup > User Defined Key. The selected settings will be displayed in the User Defined Key area of the monitor.
U 1–2
Button
Stands for ‘User Key.’ This button allows users to select a function to apply to the button. The function of each button can be set in Setup > User Defined Key. The selected settings will
▌ Functions of the Control Panel
The following are the descriptions and instructions for the controls on the control panel. For more information on controls with multiple functions, see ‘Chapter 3. Utilities’ onwards in this manual.
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Chapter 2. Introduction 2 - 11
be displayed in the User Defined Key area of the monitor.
TB/LR
Dial-button
In 3D View-MPR, this dial-button adjusts ROI boundaries. TB stands for Top-Bottom and LR stands for Left-Right.
Marker/Ref
Dial-button
Allows the user to enter a BodyMarker over an image. Moves the reference slice horizontally in 3D View.
Text
Button
Allows the user to place text on an image.
Ez Exam+
Dial-button
Use the Ez Exam+ and Preset Change features.
Button
In this mode, only the image is displayed on the screen.
Button
Compares two independent images.
Button
Compares four independent images.
Set/Exit
Button
This button is used to assign user-defined functions. The function of each button can be set in Utility > Setup > User Defined Key.
– Set: Selects an item or value using the trackball or changes
the function of the trackball.
– Exit: Exits the function currently being used and returns to
the previous state.
Pointer
Button
When this is pressed, an arrow marker appears to point to parts of the displayed image.
Clear
Button
Deletes text, indicator, BodyMarker, and measurement result, etc. displayed on an image.
Change
Button
This is used to change the current trackball function.
Calculator
Button
Starts measurements by application.
Caliper
Button
Starts to measure distance, circumference, area, and volume.
Trackball
Trackball
Moves the cursor on the screen and scrolls through Cine images.
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■ Keyboard
The keyboard is used to type in text.
[Figure 2.5 Keyboard]
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Chapter 2. Introduction 2 - 13
Patient
Displays the Patient Information screen, which is used for selecting a patient ID from the list or entering new patient information.
Probe
Displays the Probe Selection screen to select or change the probe and application.
Report
Displays the Report screen that shows the measurement results of the current application and other information.
SonoView
Runs SonoView, which is the image filing program.
End Exam
Finishes the exam of the currently selected patient and resets the related data.
▌ Touch Panel
These control tools are located on both sides of the touch screen. Available buttons are as follows:
[Figure 2.6 Touch Panel]
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Utility
The Utility Menu appears on the touch screen.
U5
Stands for User Key; functions can be assigned to these buttons as desired. The function of each button can be set in Setup > User Defined Key. The settings are displayed in the User Defined Key area in the monitor.
U4
Stands for User Key; functions can be assigned to these buttons as desired. The function of each button can be set in Setup > User Defined Key. The settings are displayed in the User Defined Key area in the monitor.
U3
Stands for User Key; functions can be assigned to these buttons as desired. The function of each button can be set in Setup > User Defined Key. The settings are displayed in the User Defined Key area in the monitor.
TGC
The TGC screen will be displayed on the touch screen. TGC stands for Time Gain Compensation.
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▌ Touch Screen
Chapter 2. Introduction 2 - 15
[Figure 2.7 Touch Screen]
The touch screen is an operating tool that can be touched by the user to input data. The functions that are available in the current mode are shown in the form of buttons or a dial­button.
■ Touch Screen Layout
① Information Area: Shows the title of the touch screen currently displayed. ② Tab Area: Shows diagnostic modes and utilities under different tabs. The touch screen
can be changed by pressing one of the tabs.
③ Menu Area: The menu items that are available in the current input mode are shown in
the form of buttons. The user can access the desired menu item by pressing the corresponding button. The menu currently in use is shown in blue.
④ Soft Menu Area: The soft menu items that are available in the current input mode are
shown.The menus in use are shown with blue borders. Press or rotate the dial­buttons right below each menu.
⑤ Quick Preset: With predefined diagnosis mode and presets of probes frequently used
by the user, this function provides quick and easy access to frequently used probe in each diagnosis mode.
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NOTE
For further details about setting up Quick Preset, please refer to Setup > General > Quick Preset > Quick Preset Setup in ‘Chapter 3. Utilities’.
CAUTION
■ Do not apply excessive force to the control panel.
■ Use the handle at the back of the product when moving it.
▌ Adjusting the Control Panel
■ Adjusting to the Right and Left
Hold the control panel handle and move it carefully to the right or left.
■ Adjusting the Height
Press the lever on the control panel handle and move it carefully up or down.
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Chapter 2. Introduction 2 - 17
[Figure 2.8 Rear Panel]
① Trig port (In/Out): Not used. ② Microphone port (Input): Connects a microphone. ③ VHS port (Output): Outputs composite image to the
monitor.
④ Audio port (Output): Outputs audio signal. ⑤ S-VHS port (Output): Outputs S-VHS image to the
monitor.
⑥ DVI port (Output): Outputs digital signal (DVI Full
HD) and analog signal (DVI RGB) to the monitor.
⑦ USB port: Used to connect to USB peripheral
devices.
⑧ Network port: Used to connect to a network. You
can transfer patient information to another server via the DICOM network.
Console
The console consists of two main parts: the interior and the exterior. The interior of the console mainly contains devices that produce ultrasound images. On the exterior of the console are various connectors, probe holders, storage compartments, handles, and wheels, etc.
▌ Rear Panel
A monitor and other peripheral devices are connected via the rear panel at the back of the system.
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TIP
Vaginal Probe Holder
Install this to fix the vaginal probe onto the holder.
▌ Power Connection Part
The power connection part is located at the bottom on the rear panel.
[Figure 2.9 Power Connection Part]
① Power switch: Supplies or blocks power to the entire system. ② Power Inlet: For the power cable to connect to external power. ③ Power Outlet: Supplies an external peripheral device with power from the product’s
internal power supply.
④ Equipotential Terminal: This should be connected to the equipotential connection part in
the exam room.
▌ Probe Holders
Probe holders are mounted at the left and right-hand sides of the control panel.
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Chapter 2. Introduction 2 - 19
CAUTION
■ Do not install a peripheral device that is not listed in this user manual in the patient environment. If you install an unlisted device in the patient environment, it may cause an electrical hazard.
■ Do not connect additional external peripheral devices to the auxiliary socket outlet. Doing so may decrease safety level.
NOTE
Refer to the user manual of the peripheral device for its operating information.
Peripheral Devices
Peripheral devices can be connected to their corresponding ports on the left/right or rear sides of the console, as needed.
[Figure 2.10 Patient Environment]
▌ Internal Peripheral Devices
These are peripheral devices mounted in the system.
■ DVD-Multi
DVD-RW, DVD+RW, DVD-R, DVD+R, CD-R, CD-RW, CD-ROM
■ Hard Disc Drive
At least 500 GB
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CAUTION
When using a peripheral device via a USB port, always turn the power off before connecting/disconnecting the device. Connection/disconnection of USB devices during power-on may lead to malfunction of the system and the USB devices.
NOTE
■ When removing the removable disk, use Utility > Storage manager.
■ USB ports are located both on the control panel and the rear panel of the
console. We recommend that you connect USB storage devices (flash memory media,
etc.) to the ports on the control panel, and other USB peripheral devices to the rear panel for convenience.
CAUTION
■ You must install a printer and driver compatible with the English version of Microsoft Windows 7. Contact Samsung Medison customer service department for inquiries about printer driver installation.
■ When connecting the printer, ensure that the printer is configured under Microsoft Windows or system setup and has been chosen as the default printer.
■ Please check the port that the printer uses before connecting. Printers should be connected to the printer port while the USB printer should be connected to the USB port.
▌ External Peripheral Devices
These are peripheral devices that can be connected for use when needed and are connected via the USB port located at the rear panel.
The following products are recommended:
■ USB Video Printer
– Black and White: Mitsubishi P95DE (Japan: Mitsubishi P95D), SONYUP-D897, SONY
UP-X898MD, SONY UP-D898MD
– Color: Mitsubishi CP-30DW, SONY UP-D25MD
■ USB Line Printer
– Black and White: Samsung ML-2955DW – Color: Samsung CLP-615ND
■ USB to RS-232C Serial Cable
USB to Serial (RS-232C) Converter with FTDI Chipset (FTDI FT232BM Compatible)
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Chapter 2. Introduction 2 - 21
NOTE
For more information about the Open Line Transfer, refer to ‘Chapter 9. Measurements and Calculations’.
NOTE
■ The system cannot recognize USB 1.1 flash memory. Remove the flash memory from the console and equip again with an appropriate device.
■ Regarding file formats that are not ordinarily saved: Please check first to see if it is possible to save the file format on a desktop PC before trying to save the file on flash memory.
■ Do not use flash memory media which contain anti-virus programs or are defective. Otherwise, the product may fail to work properly.
■ Foot Switch
– 3 Pedals HID Type
To configure the foot switch function, go to Utility > Setup > Peripherals > Foot Switch. You can select one function from the following: Freeze, Update, Record, Print1, Save, Store Clip, Volume Start, Ez Exam, PD Mode, Color Mode, M Mode, PW Mode, CW Mode, ElastoScan, TDI Mode, TDW Mode, or Biopsy.
■ Misc.
Flash Memory Media
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NOTE
For more information on probes, refer to ‘Chapter 5. Probes’ and the ‘Reference Manual’.
Probes
Probes are devices that generate ultrasound waves and process reflected wave data for the purpose of image formation.
▌ Connecting probes
To ensure the safety of the product and the probe, turn off the power before connecting the probe to, or disconnecting it from, the probe port.
1. Connect probes to the probe ports on the front panel of the system. A maximum of five probes including the CW probe can be connected at one time. The CW probe should CW only be connected to its own port.
2. To install, turn the connector turning handle clockwise.
[Figure 2.11 Probe Ports]
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Chapter 2. Introduction 2 - 23
CAUTION
Main cord set, separately certified according to the relevant standards, is to be used when supplied to EU and USA/CAN.
NOTE
Accessories can be different according to the country.
Accessories
An accessory box containing the items below is supplied with the product.
[Figure 2.12 Accessories]
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■ SMART 4D
■ CW Function
■ Cardiac Measurement
■ DICOM
■ XI STIC
■ ElastoScan
■ Panoramic
■ Stress Echo
■ Strain+
■ ADVR
■ E-Thyroid
■ Realistic Vue
■ AutoIMT+
■ E-Breast
■ 2D NT
■ Mobile Export
■ 5D Follicle
■ 5D NT
■ 5D LB
■ 5D CNS
■ HDVI
■ S-Shearwave
■ Arterial Analysis
■ DICOM Q/R
■ CEUS+
■ S-Detect for Breast
■ S-Detect for Thyroid
Optional Functions
This product has the following S/W optional functions:
For further information about optional functions, please refer to the relevant chapters in the HS70A User manual.
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Chapter 3
Chapter 3 Installing the Product
Installing the Product
Transporting ................................................................................................................. 2
Unpacking the Product ................................................................................................. 3
Installation Environment ............................................................................................... 4
Installing the Product .................................................................................................... 5
Connecting Peripherals .............................................................................................................. 7
System Power .............................................................................................................. 9
Turning the Power On ................................................................................................................ 9
Shutting Down the System ....................................................................................................... 10
Preset ................................................................................................ ......................... 11
General .................................................................................................................................... 12
Scan Mode ............................................................................................................................... 17
Display ..................................................................................................................................... 20
Annotate ................................................................................................................................... 24
Peripheral Device Settings ....................................................................................................... 29
User Defined Keys ................................................................................................................... 33
Network .................................................................................................................................... 35
DICOM Setup (Optional) .......................................................................................................... 37
Options ..................................................................................................................................... 49
System Information .................................................................................................................. 51
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Category
Temperature OC
Humidity %
Transporting
-25 ~ 60
20 ~ 90
Storage
-10 ~ 50
20 ~ 90
Operating
10 ~ 35
30 ~ 75
Transporting
This product is a finely tuned piece of medical electronic equipment; careful attention is required when transporting it.
▐Precautions when transporting the product
The box packaging is designed to reduce impact. However, take care to prevent any external impact from reaching the product.
▐Humidity and Temperature
"[Table 3-1. The Product's Humidity and Temperature Tolerance]" shown below illustrates the temperature and humidity ranges for transporting, storing, and operating the product.
[Table 3-1. The Product’s Humidity and Temperature Tolerance]
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Chapter 3. Installing the Product 3 - 3
Unpacking the Product
Dismantling the Product Box
1. Open the box.
2. Remove the protection cover.
3. Take out the probe box and accessory box and store them in a safe place.
4. Unlock the brakes on wheels.
5. Grab the rear handle on the product and move it to a place to install.
[Figure 3.1 Dismantling the Product Box]
Accessory
An accessory box containing the items below is supplied with the product. If the items are not intended for your product, contact the store where you purchased the product.
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CAUTION
Placing the system near generators, X-ray machines or broadcast cables may result in screen noise and abnormal visual images. Sharing the power source with other electrical devices may also induce noise.
Installation Environment
Caution
When installing the product, please pay attention to the following: For more information on using and setting up, refer to the accompanying manual for HS70A.
■ Optimal conditions for the system are a temperature of 10-35 and a humidity of 30-75%.
■ Avoid excess humidity.
■ Avoid direct sunlight.
■ Avoid excessive fluctuations in temperature.
■ Maintain temperature of 10 - 35 and humidity of 30 - 75% for normal operation.
■ Avoid installing the product near a heating appliance.
■ Avoid dusty and/or poorly ventilated locations.
■ Avoid locations that are subject to vibration.
■ Avoid locations where chemical substances or harmful gases are present.
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Chapter 3. Installing the Product 3 - 5
CAUTION
If the product needs to be transported or stored for an
extended duration, the temperature and humidity of the environment must be checked.
A sudden change in temperature may cause condensation and
lead to product failure.
Temperature℃
-20
-15
-10
-5 0 5
10 ~ 35
45
50
55
60
Waiting time Hour
16
10 8 6 4 2
Use
immediately
2 4 6
10
Installing the Product
Installation Safety
In a hospital environment, dangerous electric current may occur as a result of the potential difference between a contactable conductive part and connected equipment in treatment rooms. The solution to the problem is consistent equipotential bonding. Medical equipment is connected with connecting leads made up of sockets which are angled to the equipotential bonding network in medical rooms.
[Figure 3. 2 Equipotential bonding]
Refer to "[Table 3-2. Operational Temperature of Product]" before turning the product on.
[Table 3-2. Operational Temperature of Product]
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NOTE
The product may ship with the power cable connected to the console.
Power Cord Connection
Prior to connecting a power cord, verify that the voltage indicated on the power cord matches the voltage rating of the place to install.
[Figure 3.3 Power Connection Part]
Probe Connection
Be sure to turn off the power before connecting or disconnecting a probe to ensure the safety of the system and the probes.
1. Connect probes to the probe connectors on the front panel of the system. A maximum of five probes including the CW probe can be connected at one time. The CW probe should only be connected to its own connector.
2. To install, turn the connector turning handle clockwise.
[Figure 3.4 Connecting the Probe]
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Connecting Peripherals
CAUTION
Do not place peripheral devices that are not listed in this manual in the vicinity of the patient. If you place them in the patient environment, it may cause an electrical hazard.
NOTE
For more information on the recommended peripheral devices, refer to "Chapter 1. Introduction".
Chapter 3. Installing the Product 3 - 7
[Figure 3.5 Patient Environment]
▐Internal Peripheral Devices
These are peripheral devices mounted in the system.
DVD-Multi
Hard Disc Drive
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NOTE
When removing the removable disk, use Utility > Storage manager. The system cannot recognize USB 1.1 flash memory. Remove the flash
memory from the console and equip again with an appropriate device.
CAUTION
When using a peripheral device via a USB port, always turn the power
off before connecting/disconnecting the device. Connection/disconnection of USB devices during power-on may lead to malfunction of the system and the USB devices.
Do not connect additional external peripheral devices to the auxiliary
socket outlet. Doing so may decrease safety level.
▐External Peripheral Devices
These are peripheral devices that can be connected for use when needed and are connected via the USB port located at the rear panel.
USB Video Printer
USB Line Printer
USB to RS-232C Serial Cable
Foot Switch
Other Flash Memory Media
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Chapter 3. Installing the Product 3 - 9
NOTE
If the power switch near the power connection port on the rear panel
of the product has been switched off, wait for 10 seconds before turning on the product.
Do not press keyboard keys or buttons while booting is in progress.
Doing so may cause the system to malfunction.
If you turn on the power after turning it off suddenly, the system may
turn on and off momentarily. This is a characteristic of the Intel® PC main board, and not a system error.
CAUTION
Make sure to connect the probes and peripheral devices that will be used before powering on the system. If you attempt to connect them during system use, it may lead to patient injury or irreparable damage to the console.
CAUTION
Before starting the diagnosis, you must register the patient information.
System Power
Boot up the system for use.
Turning the Power On
Press the On/Off button when the power is off. Booting begins, and the product logo appears on the screen. When booting is completed, the 2D mode screen appears in End Exam status.
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CAUTION
Pressing the On/Off button for longer than five seconds will
immediately turn the power off and may damage the hard disk; do not turn off the power by using this method unless absolutely necessary.
To ensure that the product is safely cut off from electrical power, set
the power switch at the rear of the product to Off position after using the product.
Shutting Down the System
Press the On/Off button while using the system to initiate shutdown.
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Chapter 3. Installing the Product 3 - 11
※ Tip! – Selecting a tab
You can select a desired tab in either one of two ways. Select the method that suits you.
- Use the trackball and the Set button to select a tab.
- Tap a corresponding button on the touch screen.
Preset
This mode is used for system settings. It does not affect image output. The setup may be modified depending on specific needs or preferences.
1. Press the Setup button on the touch panel, or tap Utility > Setup on the touch screen.
2. The Settings screen will appear. Select a tab that has items to specify.
3. Specify settings for each item.
4. Save and close the settings. Click the Close button on the monitor screen or the Exit button on the touch screen or the control panel to switch to Scan Mode.
5. Tap Return on the touch screen to go back to the Utility menu.
[Figure 3.6 Setup - Touch Screen]
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NOTE
You cannot input the following characters: #, [, ", :, ?, |, \, "
NOTE
You cannot change the date and time when a patient ID has been
registered. Before making a change, you should finish the current diagnosis by pressing the End Exam button on the control panel.
You can select a year from 2006 to 2027.
General
In the Setup screen, select the General tab. Or tap General on the touch screen. You can specify general settings such as title settings.
[Figure 3.7 Setup - General]
▐ Title
You can specify the information that is displayed in the title area on the screen.
Institution
Enter the name of the hospital/institution where the product is installed.
Department
Enter details about the medical institution or the organization. These details are used to identify information at DICOM transfer.
Date
The current date is displayed. To change the date, press .
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Chapter 3. Installing the Product 3 - 13
※Tip! How to set the date and time
1. In the Date (or Time) field, press .
2. Set the date and time using the trackball and the Set button on the control panel.
3. When the details are correct, press Apply to apply the changes. To close the Date & Time window, press OK. To cancel, press Cancel or the Exit button on the control panel.
[Figure 3.8 Date And Time]
Date Format
Used to configure the date format. Select a format by using the combo button. The date format that you specify will be applied to various date fields in Patient Information.
Time
The current time is displayed.
Time Format
Select a time display format. Select a desired time format (12 Hour or 24 Hour) by pressing the combo button.
▐ Account
Register a user ID and password.
User Log-in
Set the user account (log-in) function. If the user log-in is set to on, it can be used for the following areas:
– Screen Saver
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NOTE
The Admin account cannot be deleted. Once the user account function is activated, you cannot load
other exams without logging in.
The password must be 6 to 15 characters and composed of at
least three of the following:
- English alphabet upper case
- English alphabet lower case
- Numbers
- Special characters
– Accessing SonoView/Patient – Search window for patient
Set ID and Password
This is the exclusive administrator function for approval and management of accounts. Account List window will be enabled.
– Add: Fill out the User ID, Password, and Name fields. Then click the Add button to
create a new ID.
– Modify: Save the changes. – Delete: Delete the selected ID. – Close: Close the settings.
Log-in
You can set the User Account ID after logging in to the Admin account. For Admin account, contact a service engineer.
▐ Screen keyboard
Auto pop-up on patient Information
Set this to on or off by using the trackball. If it is set to on, the on-screen keyboard appears automatically when entering patient information.
▐ Control
Trackball Speed For Scan Mode
Specify the trackball speed at scanning mode as Slow, Normal, or Fast.
Trackball Speed For Measurement
Specify the trackball speed at measurement as Slow, Normal, or Fast. Slower speeds allow more precise measurements.
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Zoom In
Selects the direction in which to rotate the Zoom dial to zoom in on an image.
- Clockwise: Rotating the dial-button clockwise zooms in on an image.
- Counterclockwise: Rotating the dial-button counter-clockwise zooms in on an image.
Set / Exit Key
Select the functions to assign to the buttons on the left and right sides of the trackball on the control panel.
- L: Set / R: Exit: The left button is set to Set and the right button is set to Exit.
- L: Exit / R: Set: The left button is set to Exit and the right button is set to Set.
- L: Set / R: Set: Both the left and the right buttons are assigned the Set function.
▐ Sound
Generate a buzzer sound when a button or dial-button is used.
Buzzer Sound
Set this to on or off by using the trackball. When this is set to on, the buzzer sounds each time a button or dial-button is used.
▐ Patient Information
Save patient Page as first images
Set this to on or off by using the trackball. If it is On, the Patient Information Entry screen will be saved when creating an ID.
▐ Zoom Box Setup
Zoom Box Reference Position
Select the position of the Zoom Box Reference. You may select either Image or Zoom Box.
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▐ Quick Preset
Quick Preset seutp
Press the button to display the Quick Preset Setup screen. After selecting the Probe, Application, and Preset connected to the port, press the + button to add them to Quick Preset. Up to 4 sets can be saved. The Probe, Application, and Preset saved will be shown on the touch screen in the diagnosis mode.
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NOTE
To configure the Store Clip button, go to Utility > Setup > User Defined Key > User Key Setup.
Scan Mode
Select the Scan Mode tab on the Setup screen. Or tap Scan Mode on the touch screen.
[Figure 3.9 Setup – Scan Mode]
▐ Store Clip
Store Clip Method
Specify the method and range in which an image is acquired and saved. You can select ECG Beat, Time or Manual. Note that ECG Beat can be selected only
when ECG is on.
- ECG Beat: Specify the heart beat as 1–8 beats.
- Time: Specify it as 1–600 seconds.
- Manual: Pressing the button on the control panel that has been designated as Store Clip automatically starts saving the images; pressing the same button again stops saving.
Cine Loop Period
- Retrospective: When the Store Clip button is pressed during scanning, the previous images are saved.
- Prospective: When the Store Clip button is pressed during scanning, the subsequent images are saved.
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▐ Combination Action
Freeze with
Select a function to execute when the Freeze button on the control panel is pressed. Available options are BodyMarker, Caliper, AutoCalc, Measure, Text, and None.
- D or M modes only: When 'Freeze with' is set to Measure, Measure Freeze Action will function only in Doppler and M Modes.
End Exam with
- None: Tapping the End Exam button on the touch screen exits Exam Mode and switches the screen to the B Mode Scan screen.
- Patient Window: Tapping the End Exam button on the touch screen switches the screen to the Patient Information screen.
▐ Multiple Mode
Simultaneous Mode
You can decide whether to enable Simultaneous Mode in Spectral Doppler Mode, using the following three options:
- Off: Select this if you do not wish to use Simultaneous Mode.
- Allow B / PW: Select this option if you do not wish to use Simultaneous Mode in
2D/C/PW Modes, but do wish to use it in 2D/PW Mode
- Allow B / C / PW: Select this if you wish to use simultaneous mode for both 2D/PW and for 2D/C/PW.
Color Mode Position on Dual Live
Select the position of the Color Doppler Mode in Dual Live Mode.
- Left or Top: Color Doppler Mode is located in the left or upper part of the screen.
- Right or Bottom: Color Doppler Mode is located in the right or lower part of the
screen.
- Left-Right Dual Live Mode Only: The Top-Bottom Dual button disappears when you check this checkbox.
Dual Mode
- Show ‘Change Window’ button: Select whether to activate the Change window in Dual Mode.
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NOTE
The specified items will appear on the screen only when the AutoCalc button on the touch screen is tapped in Spectral Doppler Mode.
Option
You can select multiple items. Use the trackball and the Set button to select and check or uncheck an item.
- Active HPRF on PW mode: Select whether to activate HPRF (High Pulse Repetition Frequency), which is supported in PW Spectral Doppler Mode. Check the checkbox to use the HPRF function.
- Color Map Auto invert(on linear): Check this checkbox to automatically highlight the Color Map. This is only applied when you change Steer in 2D/C/D Mode, C Mode, or DPDI Mode in PD Mode.
- M/PW Loop Side by Side: Add Loop Side By Side display in M Mode or Power Spectral Doppler Mode.
- Width Scale: Automatically fit the image size to the screen size when the depth of a
2D image is adjusted. Please note that this can be only used with linear probes.
- PW mode by M-Line: In 2D Mode, pressing the Set button when M Line is "on" will take you directly to PW Mode.
▐ Default Text
Show operator name on Scan Image
- Type: Select Diag. Physician, Ref. Physician, or Sonographer. Turn this option off
to hide it from the screen.
▐ Auto Calc.
AutoCalc is a Spectral Doppler Mode feature that automatically performs specific calculations based on measured values.
Add and remove automatic calculations by using the check boxes. You can select up to six values.
When the Peak Systolic Velocity and End Diastolic Velocity values are 0, not all results for the items will be displayed on the screen. In addition, the result value for Time Averaged Mean Velocity is displayed only when Mean Trace is turned on.
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※Tip!
The Scan Mode is frozen automatically, regardless of Auto Freeze setting, when the product is not used for 1 hour.
NOTE
In 3D mode, Auto Freeze is activated when the product is not used for 20 minutes.
Display
Select the Display tab in the Setup screen. Or tap Display on the touch screen. Configure the settings for displaying images.
▐ Power Saving
Screen Saver: Select whether or not to display the screen saver. When this is On,
you can set the screensaver to be activated in 1 to 30 minutes.
Auto Freeze in 10 minutes: Scan mode is frozen automatically when the product is
not used for 10 minutes.
[Figure 3.10 Setup - Display]
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▐ Font
Document Font
Measure Result Font
Font Name
Helvetica
Verdana
Font Size
20
11
Font Color
White
Yellow
NOTE
Certain fonts may not appear correctly on the screen.
Specify the target for which you want to set the font. Choose from Document Font and Measure Result Font. The selected font can be previewed.
Reset
Uses the system's default fonts. The default settings are as follows:
Type
Select the font type to use.
Chapter 3. Installing the Product 3 - 21
Size
Select the font size to use.
Color
Select the font color to use.
▐ S-Detect
S-Detect: BI- RADs Description
Show or hide the on-screen call text based on the BI-RADs score in S-Detect. Turn this option off to hide the call text from the screen.
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NOTE
'Age' and 'Birthday' cannot be used simultaneously.
▐ Information
Direction Marker
Set the Direction Marker. Select between SAMSUNG HS70A and HS70A.
Doppler Axis
Select the units of measurement for the axis scale in Spectral Doppler Mode.
- cm/s: Specify the Doppler axis scale unit as cm/s.
- m/s: Specify the Doppler axis scale unit as m/s.
- kHz: Specify the Doppler axis scale unit as kHz.
▐ Wide Screen Mode
The Wide Screen mode can be turned on or off by using the trackball in Single, Dual, or Quad mode. Turn this option off to set the screen to 4:3 ratio.
▐ Display
TGC Line: Select whether or not to display the TGC Line. If this feature is not used,
TGC line is displayed on the screen for 3 seconds when TGC is configured.
Image Info: Show or hide the image information. If the image information intrudes
too much on the screen, disable this option to hide it.
TI(Thermal Index) Display: Specify the TI to display on the screen as TIs (Soft tissue
Thermal Index), TIb (Bone Thermal Index), or TIc (Cranial bone Thermal Index).
Patient Name with
- Age: Select whether to display the name and age under the patient ID.
- Birthday: Select whether to display the name and date of birth underneath the patient
ID.
OB Display
Specify how the LMP, GA and EDD entered in the Patient Information screen will be displayed on the monitor screen. Select two from LMP, GA, and EDD.
- Replace Patient ID (on Top info bar): Replace the ID in the title area.
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NOTE
This button only appears on the screen in a product that supports Asian patient names.
- Replace Patient Name (on Top info bar): Show the patient name in the title area.
- Replace App. (on Top info bar): Replaces the applications in the title area.
- Measure Result: Display the measurement result along with the selected LMP, GA or
EDD.
- Off: None of the options are displayed on the screen.
▐ Patient Name Formatting
This function is to display patient names in Asian languages, such as Korean, Chinese, and Japanese.
This setting is initialized when you click Reset.
Name Formatting
Select the order in which patients' names are displayed.
- Default“Last, First Middle”: Names are displayed in the order of last name, first name, and middle name (E.g. Smith, Robert L.).
- Custom: For "Item", specify the order in which you want to display the last name, first
name, and middle name. For “Separator”, specify the symbol (such as a comma, colon,
or space) that should be used to separate each name.
Representation Priority
Patient Information Select the method for displaying patients' names. Assign priorities of 1, 2, and 3 to the
Roman, Ideographic, and Phonetic display methods.
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