Samsung RS80A Service manual

Service Manual

(Empty page)

SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

RS80A

Service Manual

English

SM-RS80A-ENG-01

(Empty page)

Safety Requirements

■ Categorization

− Type of protection against electric shock: Class I

− Degree of protection against electric shock (when the patient is in physical contact):

Type BF or type CF applied part

− Degree of protection against the ingress of harmful liquids: General equipment

− Degree of safety of use in the presence of flammable anesthetic agent mixed with air,

oxygen, or nitrous oxide: Not suitable for use near flammable anesthetic agent mixed
with air, oxygen, or nitrous oxide

− Mode of operation: Continuous operation

■ Safety standards the device conforms to

− 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

− Medical electrical equipment, part 2-37: Particular requirements for the basic safety and

essential performance of ultrasonic medical diagnostic and monitoring equipment IEC

60601-2-37:2001, 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

■ Statements

The “C” and “US” of the CSA mark certifies that the product
conforms to applicable Canadian and American standards and
has been certified by Canadian and American certification
agencies.

This mark certifies that the product conforms to applicable EEC
standards and has been certified by the European certification
agency.

This mark certifies that the product conforms to applicable EEC
standards.

GMP symbol represents the Good Manufacturing Practice and
quality standards in accordance with the Korean Quality
Standards.

Precautions for Use

Be sure to read this operation manual thoroughly, to familiarize yourself with the operation of
the product and the relevant safety information, before attempting to use the product.

■ Keep this manual near the product and refer to it when using the product.

■ Please familiarize yourself with the safety precautions in ‘Chapter 2. Safety’ and ‘Chapter 10.

Maintenance’, in particular, contain important safety information and must be thoroughly
understood.

■ This manual does not include diagnosis results or opinions. Also, check the reference

information for the measured area of the body before using the application’s measurement
results in any diagnosis.

■ This product is an ultrasound diagnosis device and cannot be used from the user’s PC. The

manufacturer is not responsible for any problems that may be caused by such attempts.

■ This product must only be used by persons who are trained and/or certified to operate

clinical diagnostic devices. Unqualified persons must not use this product.

■ The manufacturer is not responsible for any damage to this product caused by user

carelessness and/or neglect.

■ Product orders are based on individually agreed specifications and may not include all

functions specified in this manual.

■ Some functions, options, or probes may not be available in certain countries or regions.

■ All reference material on standards, regulations, and related revisions are valid at the time of

the publication of this manual.

■ Screen images in this manual are examples and may differ from the actual screen or

system.

■ The content and specifications described in this manual are 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:

DANGER

Disregarding this instruction may result in death, serious injury, or other
dangerous situations.

WARNING

Follow these instructions to prevent a serious accident, or damage to property.

CAUTION

NOTE

Follow these instructions to prevent a minor accident, or damage to property.

The accompanying information covers an installation, operation, or
maintenance procedure that requires careful attention from the user, but has
little chance of leading directly to a dangerous situation.

If You Need Assistance

Contact the Samsung Medison customer service department or your local vendor if you need a
service manual or any other support for the product.

Chapter 1

Introduction

Product Specifications ................................................................................ 3

Product Configuration ................................................................................. 6

Monitor ................................................................................................................ 8

Control Panel .................................................................................................... 11

Console ............................................................................................................. 18

Peripheral Devices ............................................................................................ 20

Probe ................................................................................................................ 23

Clear Track ....................................................................................................... 24

Accessories ...................................................................................................... 24

Optional Features ............................................................................................. 25

Product Specifications

Height: 1,342mm (with monitor)

Physical

Dimensions

Imaging modes

Width: 560mm
Depth: 980mm
Weight: 140kg (with monitor)
Weight: Approx. 155kg (with Safety Working Load)

2D Mode
M-Mode
Color Doppler
Pulsed Wave (PW) Spectral Doppler
Continuous Wave (CW) Doppler
Tissue Doppler Imaging (TDI)
Tissue Doppler Wave (TDW)
Power Doppler (PD)
S-Flow
ElastoScan Mode
Color M-Mode
Anatomical Mode
3D imaging Mode
4D imaging Mode

Chapter 1 Introduction 1 - 3

Gray Scale

Focusing

Probes

(Type BF / IPX7)

Probe connections

256 (8 bits)

Transmit focusing, maximum of eight points (four points
simultaneously selectable)
Digital dynamic receive focusing (continuous)

Linear Array: L3-12A, L5-13, L7-16, LA2-9A, LA3-16A,
LA3-16AI
Curved Array: C2-6, CA1-7A, CA2-8A, CF4-9, E3-12A
3D: V4-8, V5-9, LV3-14A
Phased Array: PE2-4, PM1-6A
CW: CW6.0

Five Active Probe Ports (include one CW probe connector)

1 - 4 RS80A Service Manual

Main Monitor

23 inch LCD monitor (LED backlight unit)
called "LCD monitor" henceforth

Monitor

Touch Screen Monitor

13.3 inch LCD monitor (LED backlight unit)
called "LCD monitor" henceforth

ECG

Rear Panel

Input / Output

Connections

Image Storage

Application

Electrical

Parameters

Measurement

Packages

USB Type (Type CF)

Audio in / out
Microphone
External Trigger in / out
External monitor DVI-I
Network
USB
Foot Switch

Maximum 12,700 frames for Cine memory
Maximum 8,192 Lines for Loop memory
Image filing system

Obstetrics, Gynecology, Urology, Abdomen, Vascular, Small
Part, Pediatric, MSK, Contrast, Cardiac, TCD

100-240V~, 1400VA, 50/60Hz

OB, Gynecology, Cardiac, Vascular, Fetal Heart, Urology,
Abdomen, Small Parts, Musculoskeletal, TCD, Pediatric Hips
* Refer the Chapter 9 for additional information

Signal processing

(Pre-processing)

Signal processing
(Post-processing)

TGC control
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

Frame average
Edge Enhancement / Blurring

Measurement

Auxiliary

Chapter 1 Introduction 1 - 5

Gamma-scale windowing
Image orientation (left/right and up/down, rotation)
White on black/black on white
Zoom

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

USB Video Printer
USB Line Printer
USB to RS-232 Serial Cable
Foot Switch (IPX8)
USB Flash Memory Media
USB HDD

User Interface

Pressure Limits

Humidity Limits

Temperature Limits

English, German, French, Spanish, Italian, Russian, Chinese

Operating: 700 – 1,060hPa
Storage: 700 – 1,060hPa

Operating: 30 – 75%
Storage & Shipping: 20 – 90%

Operating: 10 – 35C
Storage & Shipping: -25 – 60C

1 - 6 RS80A Service Manual

Product Configuration

This Product consists of monitor, control panel, console, peripheral devices and
probes.

① Monitor

⑥

③

⑦

①

②

⑩

⑪

④

⑧
⑨

⑤

② Touch Screen

③ Control Panel

④ Probe Holder

⑤ Place for Gel Warmer

⑥ Cable Holder

⑦ DVD Drive

⑧ CW Probe Port

⑨ ECG Port

⑩ Clear Track (Optional)

⑪ Probe Port

⑫ Brake

⑬ Air Filter

⑭ Wheels

⑫

⑬

[Figure 1.1 Product Front View]

⑭

Chapter 1 Introduction 1 - 7

① Monitor Arm

② USB Port

③ Motorized Lift

④ Storage Compartment

⑤ Handle

①

②

⑥ Air Vent

⑦ Power Receptacle

⑧ Rear Panel

⑨

③

⑦

⑤

⑥

⑨ Cable Holder

④

⑧

[Figure 1.2 Product Rear View]

1 - 8 RS80A Service Manual

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 the ①

Title area, Preset Change and Ez Exam area, Image area, Thumbnail
area, User Information, and  User defined key area.

①

②

③

⑤

[Figure 1.3 Screen Layout]

① Title Area

Displays patient information, hospital name, application, frame rate, depth,
probe information, acoustic output information, and the current date and
time.

② Preset Change and Ez Exam area

⑥

④

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.

NOTE

③ Image Area

Displays ultrasound images. TGC, image information, annotation, and
measurement information are also displayed.

④ Thumbnail Area

Images saved by selecting Save are displayed as thumbnails. If saving
Single screens, up to 5 images are shown in a list; for Quad screens, up to
20 images can be displayed. Clicking with the pointer will enlarge the
selected thumbnail in the Image area.

⑤ User Information Area

Information that is useful to the user, such as current system status, image
information, selectable items, etc., is displayed.

Chapter 1 Introduction 1 - 9

You can set up the Ez Exam menu in Ez Exam Setup.
For more information, please refer to ‘Chapter 3.
Utilities’.

⑥ User Key (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

Key.

NOTE

For information on User Key Setup, please refer to
‘Chapter 3. Utilities’.

Setup > User Defined

1 - 10 RS80A Service Manual

 Principles of Operation of Diagnostic Ultrasound System

Medical ultrasound images are created by digital memory and computer when
they convert 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 in the storage device in real time.

The entire process of transmitting, receiving, and processing signals is
controlled by the computer.

Control Panel

You control the system by using the control panel.

Chapter 1 Introduction 1 - 11

[Figure 1.4 Control Panel]

The control panel consists of soft menus, buttons, dials, dial-buttons, slider, and
track.
The dial-button can be used both as a dial and a button.

1 - 12 RS80A Service Manual

▐ 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
and later in this manual.

Button Turns the system on/off.

On/Off

2D Dial-button

M Button

PD Button

PW / Y Dial-button

C / Z

Angle / X

Dial-button

Dial-button

Button: Starts 2D Mode.

Dial: Adjusts the 2D gain.

Start or end M-Mode.

Press this button to start/stop Power Doppler mode.

Button: Press this button to start/stop PW Spectral
Doppler mode.

Dial: Adjusts the PW gain. In 3D View, rotates the
image along the Y-axis.

Button: Press this button to start/stop Color Doppler
mode.

Dial: Adjusts the C gain. In 3D View, rotates the
image along the Z-axis.

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.

Dial: In 3D View, rotates the image along the X-axis.

Depth

Focus

Zoom

Switch

Switch

Dial-button

Adjusts the scanning depth of the image.

Changes location and number of focus on the target
location you wish to study.

Magnifies an image.

Chapter 1 Introduction 1 - 13

Press this button to turn the Quick Scan function on.

Q scan

Button

The ‘Q scan’ mark will appear at the top of the
image. It can be used only in specific applications of
specific probes.

Freeze

U 1~3 Button

P 1~2

Set/Exit

Button

Button

Button

Pauses/resumes scanning.

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.

Stands for Peripheral 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.

This button is used to assign user-defined
functions. The function of each button can be set in
Setup > User Defined Key.

Set: Select an item or value using the trackball. Also
used to change the function of the trackball.

Exit: Exits the function currently being used and
returns to the previous state.

Ez Exam Dial-button

Clear

Change

Calculator

Caliper

Trackball Trackball

Button

Button

Button

Button

Uses the Ez Exam and Preset Change features.

Deletes text, indicators, BodyMarkers,
measurement results, etc. displayed on an image.

Switch the trackball's current function to the next
supported function.

Start measurements for the application.

Start taking basic measurements such as distance,
circumference, area, and volume.

Moves the cursor on the screen. Also scrolls
through Cine images.

1 - 14 RS80A Service Manual

Soft Menu

Dial-button:

Selects Soft Menu or changes the settings of the
selected Soft menu.

▐ 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 dial-button.

 Touch Screen Layout

①

②

④

③

⑤

⑥

⑦

[Figure 1.5 Touch Screen]

① These buttons are always displayed on the touch screen. Buttons that are

in use are shown in blue, and buttons that cannot be used are deactivated.

Patient

End Exam

Probe

Displays the Patient Information screen, which is used for selecting a

patient ID from the list or entering new patient information.

Finishes the exam of the currently selected patient and resets the
related data.

Displays the Probe Selection screen to select or change the probe

and application.

⑧

Chapter 1 Introduction 1 - 15

Report

SonoView

Pointer

3D

Setup

Displays the Report screen, which shows the summary of

measurement results of the current application.

Launches SonoView, an image filing program.

Displays an arrow-shaped pointer on the screen. This can be used in
Diagnosis mode.

Starts or ends 3D mode.

Displays the Setup screen, where you can change the various
settings of the product.

② Displays the mode that is currently in use.

③ The current Diagnosis mode and Utility are displayed in separate tabs. The

tab currently in use is shown in blue; pressing the tab changes the content
of the touch screen.

 Changing Touchscreen Tabs

You can also change tabs by performing a page-turn action by dragging on
the touch screen.

④ The menu items that are available in the current input mode are shown as

buttons. The menu currently in use is shown in blue.

⑤ These buttons are always displayed on the touch screen. Buttons that are

in use are shown in blue, and buttons that cannot be used are deactivated.

Back Exits the current screen and returns to the previous state.

Exit

Quad

Single

Dual

BodyMarker

Exits the function currently being used and returns to the Scan
mode.

Changes to Quad mode. Up to four images are displayed on the
screen.

Changes to Single mode. Only one image is displayed on the
screen.

Changes to Dual mode. Up to two images are displayed on the
screen.

Changes to the BodyMarker screen.

1 - 16 RS80A Service Manual

Annotation

Keyboard Displays the Screen Keyboard.

Changes to the Annotation screen.

[Figure 1.6 Screen Keyboard]

⑥ This is the TGC area. Ten sliders for controlling Gain are displayed here.

Moving the slider to the right increases the Gain, which makes the image
brighter. TGC stands for Time Gain Compensation.

An excessively large difference between the Gain value

CAUTION

settings of adjacent TGC sliders may cause stripes to
appear in an image.

⑦ The Soft Menu items that are available in the current input mode are shown.

The menu currently in use is shown in blue. Tap a touch screen button or
use the Soft Menu dial-button on the control panel to change settings.

⑧ Changes the page of the touch screen.

▐ Adjusting the Control Panel

 Do not apply excessive force to the control panel.

CAUTION

 Adjusting Left-Right/Forward-Back

Press and hold one of the two buttons at the center of the control
panel handle, and move carefully to the left or right to adjust the position.
Release the button to fix the control panel in the current position.

 Moving Up and Down

 To transport the product, use the handle at the rear of

the console.

Chapter 1 Introduction 1 - 17

Press the
panel handle to adjust the position vertically.

automatic switch located at the center of the control

1 - 18 RS80A Service Manual

Console

The console consists of 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 holder, storage compartment, handle, wheels,
etc.

▐ Rear Panel

Rear Panel is located at the back of the product; it connects the system to the
monitor and other peripheral devices.

① Microphone Port (Input): Connects a

microphone.

 S-VHS port (Output): Provides an S-VHS

connection for a VCR.

 VHS Port (Output): Provides a VHS

connection for a VCR.

 Audio Port (Output): Outputs audio signal.

 RGB Port (Output): Provides analog RGB

signal output (supports 1280*1024
resolution).

 Trig Port (In/Out): Not used.

⑦ Network Port (Input/Output): Used to connect

to a network. Via DICOM network, patient
information can be transferred to other
servers.

⑧ USB Port (Input/Output): Used to connect to

USB peripheral devices.

⑨ HDMI Port (Output): Outputs digital signals to

the monitor. Use of a DVI monitor via a DVI
adapter or cable is not recommended
(supports 1920x1080 resolution only).

 B/W Port (Output): Not used.

[Figure 1.7 Rear Panel]

Chapter 1 Introduction 1 - 19

①②③ ④

▐ Power Receptacle

The power connection part is located at the bottom on the rear panel.

[Figure 1.8 Power Receptacle]

Power Outlet (Input): The power supply inside the product supplies electricity 

to external peripheral devices.

Power Inlet: Accepts the power cord, which connects to an external power 

supply.

Power Switch: Supplies or cuts power to the entire system.

④ Equipotential terminal: Must be connected to the equipotential bonding in a
treatment room.

▐ Probe Holder

Probe holders are mounted at the left and right sides of the control panel.

1 - 20 RS80A Service Manual

Peripheral Devices

Peripheral devices can be connected to their corresponding ports on the left/right or
rear sides of the console.

■ Do not install peripheral devices that are not listed in this

manual within the patient environment. If you install an
unlisted device in the patient environment, it may cause an

CAUTION

electrical hazard.

■ Do not connect additional peripheral devices to socket of the

auxiliary socket. Doing so may decrease the safety level.

NOTE

[Figure 2.9 Patient Environment]

For instructions on operating a peripheral device, please refer to the
operation manual for the device.

Chapter 1 Introduction 1 - 21

▐ Internal Peripheral Devices

These are peripheral devices mounted inside the system.

 DVD-Multi

DVD-RW, DVD+RW, DVD-R, DVD+R, CD-R, CD-RW, CD-ROM

 Hard Disc Drive

Min. 64Gbytes SATA SSD

▐ External Peripheral Devices

External peripherals are mounted when their use is desired by the user; they are
usually connected via appropriate ports on the Rear Panel.

When using a peripheral device via a USB port, always turn the
power off before connecting/disconnecting the device.

CAUTION

Connecting or disconnecting a USB device while power is
turned on may cause the system and/or the USB device to
malfunction.

 Use Utility > Storage Manager to mount or dismount a

removable disk.

 USB ports are located on the console and the Rear

NOTE

The following products are recommended:

 USB Video Printer

- BW: Mitsubishi P-95DE, Sony UP-D897, Samsung ML-2955DW

- Color: Mitsubishi CP-30DW, Sony UP-D25MD, Samsung CLP-615ND

Panel.

We recommend that you connect USB storage devices
(flash memory media, etc.) to the ports on the console,
and other USB peripheral devices to the Rear Panel for
convenience.

1 - 22 RS80A Service Manual

■ You must install a printer and drivers that are compatible
with the English version of Microsoft Windows 7
Samsung Medison customer support division for inquiries
about printer driver installation.

■ When connecting a printer, make sure that it is the same as

CAUTION

 USB to RS-232C Serial Cable

USB to Serial (RS-232C) Converter with FTDI Chipset (FTDI FT232BM

Compatible)

NOTE

 Foot Switch

the printer that is configured in Microsoft WindowsTM or
Setup.

■ Please note that different printers are connected via
different ports. Printers should be connected to the printer
port while the USB printer should be connected to the USB
port.

For more information about the Open Line Transfer,
refer to ‘Chapter 9. Probes’.

TM

. Contact

- 3 Pedals HID Type

To assign functions to the foot switch, go to Setup > Peripherals > Foot
Switch. You may select Freeze, Update, Record, Print1, Save, Store
Clip, Volume Start, or Ez Exam.

 Other

Flash Memory Media

NOTE

■ If you are using USB 1.1 flash memory, the
system may fail to recognize the device. Remove
the flash memory from the console and equip
again with an appropriate device.

■ When using a flash memory device which
supports functions other than saving files, please
check first to see if it is possible to save the file on
a desktop PC.

Chapter 1 Introduction 1 - 23

Probe

Probes are devices that generate ultrasound waves and process reflected wave
data for the purpose of image formation.

NOTE

For more information on probes, refer to ‘Chapter 5. Probes’
and the ‘Reference Manual’.

▐ Connecting Probes

Be sure to turn the power off before connecting or disconnecting a probe to
ensure the safety of the system and the probe.

1. Connect probes to the probe connectors on the front panel of the system.
Up to four (five including CW) probes may be connected. The CW probe
should only be connected to its own connector.

2. To mount, turn the connector turning handle clockwise.

[Figure 1.10 Probe Connector]

1 - 24 RS80A Service Manual

Clear Track

NOTE

Clear Track assists inexperienced practitioners to conduct a biopsy accurately and
safely; it improves on the older biopsy function, in which the position and the
direction of the biopsy always had to be predetermined. It also prevents the needle
from damaging an organ during a biopsy.

Clear Track consists of Clear Track System and Clear Track Stand. For more
information on using Clear Track, please refer to the instruction manual for this
product and Clear Track.

Clear Track is an optional feature of this product.

Accessories

A box containing various accessories is supplied with the product.

[Figure 1.11 Accessories]

Optional Features

This product has the following optional features:

Chapter 1 Introduction 1 - 25

Smart 4D

Cardiac Measurement

XI STIC

ElastoScan

Panoramic

HDVI

ADVR

For more information about these optional features, please refer to the relevant
sections in this manual.

E-Thyroid

Realistic Vue

S-Detect

Clear Track

Auto IMT+

E-Breast

Chapter 2

Safety

Safety Instructions ..................................................................................... 3

Contraindications .................................................................................................. 3

Safety Information ...................................................................................... 4

Safety Symbols ..................................................................................................... 4

LABEL ................................................................................................................... 8

Electrical Safety ........................................................................................ 10

Prevention of Electric Shocks ............................................................................. 10

ECG-Related Information ................................................................................... 12

ESD ..................................................................................................................... 13

EMI ...................................................................................................................... 13

EMC .................................................................................................................... 14

Mechanical Safety .................................................................................... 23

Caution on Transporting ..................................................................................... 23

Caution on Use ................................................................................................... 24

Biological Safety ...................................................................................... 27

ALARA Principle ................................................................................................. 27

Protecting the Environment .................................................................... 45

Chapter 2. Safety 2 - 3

Safety Instructions

Ultrasound diagnostic system and probes were designed for obtaining ultrasound

images and analyzing human blood; their clinical applications are as follows:

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.

Contraindications

This product must not be used for ophthalmological application, or any other use that

involves the ultrasound beam passing through the eyeball.

CAUTION

For information on the use or clinical application of this
product, please refer to ‘Chapter 6. Starting Diagnosis’ and
‘Chapter 7. Diagnosis Mode’ in this operation manual.

2 - 4 RS80A Service Manual

Safety Information

Please read the following safety information before using this product. It contains

information on the ultrasound system, probes, recording device, and other peripherals.

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 Electrotechnical 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.

Symbols Description

Warning: Follow these instructions to prevent a serious accident, or
damage to property

Caution: Follow these instructions to prevent a minor accident, or
damage to property

Please refer to the operation manual.

Follow the operation manual.

Chapter 2. Safety 2 - 5

Symbols Description

Caution: Risk of electric shocks

Type BF applied part (category of protection against electrical danger)

Defibrillation-proof type CF applied part (category of protection
against electrical danger)

Power on/off

Power on

V~

Power off

Product is partially powered on

Power off for part of the product

AC (alternating current) voltage source

Direct current voltage source

Indicates dangerous voltages over 1,000 V AC or over 1,500 V DC.

Protective grounding terminal

2 - 6 RS80A Service Manual

Symbols Description

Equipotential terminal

Data output port

Data input port

Data input/output port

Input port

Output port

Print remote output

Foot Switch port

Electrocardiograph port

IPX 1

USB port

Network port

Microphone port

Probe Port

Dripping-proof device: Protected against vertically falling water

Chapter 2. Safety 2 - 7

Symbols Description

IPX 7

IPX 8

Immersion-proof device: Protected against the effects of non­continuous immersion in water

Submersion-proof device: Protected against the effects of continuous
immersion in water

Caution: Device is sensitive to electrostatic discharge (ESD)

Do not sit on the product.

Do not push the product.

Do not lean against the product.

Mind the empty space. Do not place hand, finger, or any other part of
the body in the empty space.

Patients with heart assist device must not come near.

2 - 8 RS80A Service Manual

LABEL

Warning and caution labels that contain information and instructions concerning

the protection of the product can be found on the exterior of the product.

[Label 1. Example of ID Label]

[Label 2. Example of Probe ID Label]

Chapter 2. Safety 2 - 9

[Label 3. Example of Probe Label]

[Label 4. Example of Clear Track Stand ID Label]

2 - 10 RS80A Service Manual

Electrical Safety

This equipment has been categorized as a Class I device with Type BF applied

parts or CF applied parts (ECG).

Prevention of Electric Shocks

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. Equipotential terminal of a medical equipment should be

connected to the equipotential bonding network in medical rooms as shown in the

picture.

[Figure 2.1 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

configurations must comply with the requirements for medical electrical systems

Chapter 2. Safety 2 - 11

(IEC 60601-1-1/EN 60601-1-1). When connecting a peripheral to the signal input or

output port of medical equipment, you must make sure that the peripheral complies

with the IEC 60601-1-1/EN 60601-1-1 specification.

■ 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. The interior of this
product contains dangerous high-voltage electricity. All
interior servicing of the product or replacement of parts
must be performed by Samsung Medison.

■ Always check the product's housing, cables, cords, and
plugs before using the product. Disconnect the power
source and do not use the equipment if the housing is
damaged (for example cracked or chipped), or if the cable
is worn.

■ Always disconnect the system from the wall outlet prior to

WARNING

cleaning the system.

■ All equipment that comes in physical contact with the
patient, such as probes and ECG leads, must be detached
from the patient prior to using high-voltage defibrillator.

■ Never use the product in the presence of flammable or
anesthetic gas. There is a risk of explosion.

■ Avoid installing the system in such a way that it is difficult
for the operator to disconnect it from the power source.

■ Do not use together with HF surgical equipment. HF
surgical equipment may be damaged, which may result in
fire.

■ The System must only be connected to a supply mains
with protective earth to avoid risk of electric shock.

2 - 12 RS80A Service Manual

■ 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. The isolation transformer continues to operate
when the system is in standby.

■ Do not immerse the cable in liquids. Cables are not

waterproof.

CAUTION

■ The auxiliary socket outlets installed on this system are

rated 100-240VAC, with a maximum total load of 150VA.
Use these outlets only 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 that are not listed in

this operation manual to the auxiliary socket outlet of the
system. Doing so may cause an electrical hazard.

■ Do not touch SIP/SOP and the patient simultaneously.

There is a risk of electric shock from leakage current.

ECG-Related Information

■ This product does not provide an ECG monitoring function.
Therefore, it does not recognize unsuitable ECG signals.

■ Do not use ECG electrodes for HF surgical equipment. HF
surgical equipment may be damaged, which may result in

WARNING

fire.

■ Do not use ECG electrodes during cardiac pacemaker

procedures or any procedures that involve other types of
electrical stimulators.

■ Do not use ECG leads and electrodes in an operating room.

Chapter 2. Safety 2 - 13

ESD

Electrostatic discharge (ESD), which is commonly referred to as static shock, is a

naturally occurring phenomenon. ESD is most prevalent during conditions of low

humidity, including during heater or air-conditioner use. The static shock or ESD is

a discharge of the electrical energy build-up from a charged individual to a less- or

non-charged individual or object. An ESD occurs when an individual with an

electrical energy build-up comes in contact with conductive objects such as metal

doorknobs, file cabinets, computer equipment, and even other individuals.

■ The level of electrical energy discharged from a system user
or patient to an ultrasound system can be significant enough
to cause damage to the system or probes.

■ Always perform the ESD preventive procedure before using
connectors bearing the ESD warning symbol.

CAUTION

- Apply anti-static spray to carpets or linoleum.

- Use anti-static mats.

- Ground the product to the patient’s table or bed.

■ It is highly recommended that the user be given training on

ESD-related warning symbols and preventive procedures.

EMI

Although this system has been manufactured in compliance with existing EMI

(ElectroMagnetic Interface) requirements, use of this system in the presence of an

electromagnetic field can cause degradation of the ultrasound image or product

damage.

If this occurs often, Samsung Medison suggests a review of the environment in

which the system is being used, to identify possible sources of electromagnetic

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.

2 - 14 RS80A Service Manual

If electromagnetic waves are causing interference with the

CAUTION

operation of the system, relocate the product far away from the
EMI.

EMC

The testing for EMC (Electro-Magnetic Compatibility) of this system has been

performed according to the international standard for EMC with medical devices

(IEC-60601-1-2). In Europe, the European Standard (EN 60601-1-2) is adopted as

the IEC Standard.

▐ Guidance and Manufacturer’s Declaration –

Electromagnetic Emission

This product is intended for use in the electromagnetic environment specified

below. The user must make sure that this product is used in the following

environment.

Emission Test Compliance Electromagnetic Environment - Guidance

The ultrasound system only uses RF energy to

RF emission

CISPR 11

RF emission

CISPR 11

Harmonic emission

IEC 61000-3-2

Group 1

Class A

Class A

operate the internal functions. Therefore, the
RF energy emitted is very low, and unlikely to
cause interference to nearby electronic
equipment.

The ultrasound system is suitable for use in all
environment except residential environment.
By paying attention to the following warning,
the system may be used in environments
where electricity is supplied to a residential

Chapter 2. Safety 2 - 15

Emission Test Compliance Electromagnetic Environment - Guidance

building, or when it is directly connected to a
low-voltage common power supply network
that supplies electricity to residential buildings.

Flicker emission

IEC 61000-3-3

Compliant

Warning: This system must be used only by
qualified healthcare professionals. This system
may cause radio interference, or interfere with
operation of nearby equipment. You must take
alleviating measures by reorienting, relocating,
or shielding the ultrasound system.

▐ Approved Cables, Probes and Accessories for EMC

 Cable

Cables connected to this product may affect its emissions;

use only the cable types and lengths listed in the table below.

Cable Type Length

VGA Shielded General

RS232C Shielded General

USB Shielded General

LAN (RJ45) Twisted pair Unlimited

S-Video Shielded General

Foot switch Shielded 2.99m

B/W printer Unshielded coaxial General

MIC Unshielded Unlimited

Remote printer Unshielded Unlimited

Audio R.L Shielded General

VHS Shielded General

ECG AUX input Shielded < 3m

Parallel Shielded General

2 - 16 RS80A Service Manual

 Probe

The probes used with this product may affect the electromagnetic

emissions of the product. Probes listed in ‘Chapter 9. Probes’ meet the

Group 1, Class A requirements of the CISPR 11 standard.

 Peripheral Devices

Peripheral devices used with this product may affect the electromagnetic

emissions of the product.

Before connecting one of your own accessories to the

CAUTION

system, you must verify the system's electromagnetic
compatibility.

The use of unapproved cables, probes, and

WARNING

accessories may result in increased emission or
decreased immunity of the ultrasound system.

Immunity Test

Electrostatic
discharge (ESD)

IEC 61000-4-2

Electrical fast
transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

IEC 60601
Test Level

±6KV contact
discharge

±8KV air discharge

±2KV

(for power supply
cables)
±1KV

(for input/output
cables)

±1KV differential
mode

±2KV common
mode

Regulation Level

±6KV contact
discharge

±8KV air
discharge

±2KV

(for power
supply cables)
±1KV

(for input/output
cables)

±1KV differential
mode

±2KV common
mode

Electromagnetic

Environment -

Guidance

Floor must be made of
wood, concrete, or
ceramic tiles.
If floor is made of
synthetic material,
relative humidity must be
maintained at 30% or
higher.

The quality of main
power supply must be
equal to the quality of
power supply that is used
in general commercial or
medical environments.

The quality of main
power supply must be
equal to the quality of
power supply that is used
in general commercial or
medical environments.

Chapter 2. Safety 2 - 17

Immunity Test

Voltage dips,
short
interruptions, or
voltage variations
in power supply
cables

IEC 61000-4-11

Commercial
frequency
(50/60Hz) EM
field

IEC 61000-4-8

IEC 60601
Test Level

<5%Uт within 0.5

cycle
(>95% dip, unit:

Uт)

40%Uт within 5

cycles

(60% dip, unit: Uт)

70%Uт within 25

cycles

(30% dip, unit: Uт)

<5%Uт for 5

seconds
(<95% dip, unit:

Uт)

3A/m 3A/m

Regulation Level

<5%Uт within 0.5

cycle
(>95% dip, unit:

Uт)

40%Uт within 5

cycles

(60% dip, unit: Uт)

70%Uт within 25

cycles

(30% dip, unit: Uт)

<5%Uт for 5

seconds
(<95% dip, unit:

Uт)

Electromagnetic

Environment -

Guidance

The quality of main
power supply must be
equal to the quality of
power supply that is used
in general commercial or
medical environments. If
operation must continue
during a failure of the
main power, it is
recommended that power
is supplied through an
uninterruptible power
supply or a battery .

The electromagnetic field
from power frequency
must be equal to the EM
field in general
commercial or medical
environments.

Note: Uт is the primary voltage (AC) before applying test level.

2 - 18 RS80A Service Manual

Immunity Test

RF conduction
IEC 61000-4-6

RF radiation
IEC 61000-4-3

IEC 60601 Test

Level

3Vrms
150kHz

~ 80MHz

3V/m
80MHz

~ 2.5GHz

Regulatio

n Level

0.01V

3V/m

Electromagnetic Environment -

Guidance

Portable/mobile RF communication
equipment must be separated by the
recommended separation distance from
the cable and other specific
components of the ultrasound system.
Recommended separation distance is
calculated by using an equation that is
applicable to the frequency of the
transmitter.

Recommended separation distance

80MHz ~ 800MHZ

800MHz ~ 2.5GHz

P is the maximum rated power output

(W) provided by the manufacturer of the

transmitter, and d is the recommended

separation distance (m).

According to on-site inspection of
electromagnetic waves, the electric field
strength of a fixed RF transmitter
be lower than the level specified in the
regulation at each frequency range (

a

must

b

).

Interference may occur near equipment
bearing the following symbol:

Note 1) At 80MHz and 800MHz, greater frequency range is applied.
Note 2) This guidance may not apply to all circumstances. Radio waves of electromagnetic
waves are affected by absorption and reflection by structure, objects, and persons.

Chapter 2. Safety 2 - 19

a

It is not theoretically possible to precisely predict the electric field strength of fixed
transmitters such as wireless (mobile/wireless) telephones, base stations for industrial
radio, amateur radio communication, AM/FM radio stations, and TV stations.
electromagnetic wave environment of a fixed RF transmitter, an on-site investigation of EM
waves needs to be considered.
ultrasound system is used exceeds the level of applicable RF regulation, you must verify
whether the ultrasound system is functioning normally.
be functioning abnormally, you need to take corrective measures such as reorienting or
relocating the system, or isolating the system in a shielded space with high RF shielding
effect and filter attenuation.

b

If the frequency range exceeds 150kHz ~ 80MHz, the strength of electric field must be
lower than V

V/m.

1

If the strength of electric field measured at the location the

If the ultrasound system is found to

To assess the

▐ 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 user can help to prevent

electromagnetic interference by maintaining a minimum distance between

portable and mobile RF communications equipment (transmitters) and this

product, and by controlling the maximum output of communication equipment

as recommended below:

Separation Distance by Transmitter Frequency m

Maximum Rated

Power Output of

Transmitter

W

0.01 35.00 0.11 0.23

0.1 110.68 0.36 0.73

1 350.00 1.16 2.33

10 1106.80 3.68 7.37

100 3500.00 11.66 23.33

150kHz ~ 80MHz 80MHz ~ 800MHz

V1=0.01Vrms E1=3V/m E1=3V/m

800MHz ~ 2.5GHz

2 - 20 RS80A Service Manual

For transmitters whose maximum rated power output is not listed in the above list, an

approximate recommended separation distance d (m) can be calculated by using the
equation applicable to the frequency of the transmitted. p represents the maximum

rated power output (W) of the transmitter that is provided by the manufacturer of the
transmitter.

Note 1) At 80MHz and 800MHz, a separation distance for greater frequency range is
applied.
Note 2) This guidance may not apply to all circumstances. Radio waves of
electromagnetic waves are affected by absorption and reflection by structure, objects,
and persons.

▐ Electromagnetic Environment – Guidance

Ultrasound systems must be used only in shielded locations offering at least the

minimal level of RF shielding effectiveness, and where all the cables are also

shielded. Field strengths outside the shielded location from fixed RF

transmitters, as determined by an electromagnetic site survey, should be less

than 3V/m.

It is essential to verify that the actual shielding effectiveness and filter

attenuation of the shielded location meet the minimum specifications.

If the system is connected to customer-supplied equipment,
such as a local area network (LAN) or a remote printer,

CAUTION

Samsung Medison cannot guarantee that the remote
equipment will work correctly in the presence of
electromagnetic emission phenomena.

Chapter 2. Safety 2 - 21

▐ Avoiding Electromagnetic Interference

Typical interference on Ultrasound Imaging Systems varies depending on

Electromagnetic phenomena. Please refer to the following table:

Imaging

Mode

2D

M

Color

1

RF2 Power Cable3

ESD

When you change
the operation mode
or system setting,
or reset the
system,
Brief flickering
appears on the on­screen image or
recorded image.

For sector imaging
probes, white radiating
bands or flickerings
appear on the center
line of the image.
For linear imaging
probes, white radiating
bands appear;
sometimes they
appear more clearly
around the periphery
of the image.

Background noise of
the image increases,
or white M-Mode line
appears.

Color flickers,
radiating/vertical band
appears, background
noise increases, or
color image changes.

White dots, dashes, or
diagonal lines appear,
or diagonal lines
appear near the
center of the image.

White dots, dashes, or
diagonal lines appear,
or background noise
of the image
increases.

Color flickers, dots or
dashes appear, or
amount of color noise
changes.

Horizontal lines
appear on the

Doppler

1. ESD that occurs when the charge accumulated in insulated flooring or human body is
discharged

2. RF energy generated by RF transmitters such as mobile phones, portable radios,
wireless equipment, commercial radio, and TV

3. Interference caused by switching the power supply that is connected to power cables
or connected cables, electrical control, or natural phenomena such as lightning

spectrum display,
abnormal noise is
heard on the speaker,
or both.

Vertical lines appear
on the spectrum
display, popping noise
is heard on the
speaker, or both.

2 - 22 RS80A Service Manual

A medical device can either generate or receive electromagnetic interference.

The EMC standards describe tests for both emitted and received interference.

Samsung Medison’s ultrasound systems do not generate electromagnetic

interference in excess of the referenced standards.

An ultrasound system is designed to receive signals at radio frequency, and is

therefore 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 probe operating at the same

frequency or with several probes?

- Do two different probes 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. Answer each of the questions

and then contact a Samsung Medison Service Representative in your area.

Chapter 2. Safety 2 - 23

Mechanical Safety

Caution on Transporting

The product weighs more than 100kg. Be extra careful when

WARNING

 Before transporting the product, make sure that the brakes on the wheels are

unlocked. Also, be 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 such as the

transporting it. Careless transportation of the product may
result in product damage or personal injury.

product falling over may seriously damage the product.

If the product fails to operate normally after being transported, contact the

Samsung Medison Service Department.

▐ Brake

Use the brake to control the movement of the product. The brake is located at

the center of the footplate; you can control all wheels at once by using the

footplate.

To lock the brakes, press the front part of the brake with your foot. To unlock

the brakes, press the back of the pedal.

We recommend that you lock the brakes when using the product.

2 - 24 RS80A Service Manual

▐ Precautions on Ramps

Always make sure that the control panel is facing the direction of movement.

Be aware of the castors, especially when moving the

WARNING

If you leave the product on an incline, the product may fall over even if the

brakes are engaged. Avoid leaving the product on an incline.

system. It is recommended that you practice beforehand
before climbing up or down an incline.

Caution on Use

■ Do not press the control panel excessively.

■ Never attempt to modify the product in any way.

■ Read the instructions on safe operation of the product if

using the product after a prolonged period of non-use.

CAUTION

■ Make sure that other objects, such as metal pieces, do not
enter the system.

■ Do not block the ventilation slots.

■ Do not pull on the power cord to unplug the product. Doing

so might damage the cord and cause the product to short­circuit, or the cord itself to break. Unplug the cord by pulling
on the plug itself.

■ Excessive bending or twisting of cables on patient-applied

parts may cause failure or intermittent operation of the
system.

■ Improper cleaning or sterilization of a patient-applied part
may cause permanent damage.

■ All internal component repairs and part replacements 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 lifespan of the
product is approximately 7 years.

Chapter 2. Safety 2 - 25

For information on cleaning, disinfecting, and other information on protecting the

product, refer to ‘Chapter 10. Maintenance’.

▐ Caution on Using Monitor

When adjusting the height or position of the monitor, be careful of the space in

the middle of the monitor arm. Catching your fingers or other body parts in it

may result in injury.

[Figure 2.2 Caution on Using the Monitor]

▐ Caution on Using Control Panel

■ Do not push the control panel with excessive force or lean

CAUTION

When adjusting the height or position of the control panel, pay attention to the

space between the control panel and the lift. Catching your fingers or other

body parts in it may result in injury.

on it.

■ Do not sit on the control panel or exert excessive force on
it.

[Figure 2.3 Caution on Using the Lift]

2 - 26 RS80A Service Manual

 Caution on Using Touch Screen

CAUTION

When adjusting the angle of the touch screen, mind the space behind the

touch screen. Catching your fingers or other body parts in it may result in injury.

Do not push the touch screen with excessive force.

[Figure 2.4 Caution on Adjusting Touch Screen Angle]

Chapter 2. Safety 2 - 27

Biological Safety

For safety information on the probe and biopsy kit, refer to ‘Chapter 9. Probes’ in

this manual.

■ 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.

WARNING

Write down the message displayed on the screen, turn off the
power, and call the Samsung Medison service department.

■ Do not use a system that exhibits erratic or inconsistent
updating. Discontinuities in the scanning sequence are an
indication of a hardware failure that should be corrected
before use.

■ The system limits the maximum contact temperature to
43SYMBOLC, and the ultrasonic waves output observes
American FDA regulations.

ALARA Principle

Performing diagnoses using an ultrasound device is defined by the “As Low As

Reasonably Achievable” (ALARA) principle. The decision as to what is reasonable

has been considered and defined by many people. However, no set of rules can be

formulated that would be sufficiently complete to dictate the correct response for

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

2 - 28 RS80A Service Manual

of the exam.

The user’s knowledge of, and the ability to abide by, the ALARA principle is very

important. Advances in diagnostic ultrasound, not only in the technology, but also

in the applications of the technology, have resulted in the need for more and better

information to guide the user. This important information is based on a variety of

ultrasound output data, and plays an important role in putting the ALARA principle

into effect.

Numerous variables affect the output data that forms the basis of the provided

information. These variables include mass, body size, location of the bone relative

to the focal point, attenuation in the body, and ultrasound exposure time. Among

these, exposure time is the variable that one must pay the most attention to. For,

unlike other variables, exposure time is entirely controlled by the operator of the

ultrasound system.

▐ 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 unscanned modes like M-Mode or Doppler concentrate

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 definition of 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 bioeffect is actually

Chapter 2. Safety 2 - 29

occurring, a high index reading 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. These controls can

be divided into three categories: direct, indirect, and receiver controls.

▐ Direct Controls

Application selection and the output intensity control directly affect acoustic

intensity. There are different ranges of allowable intensity or output based on

your selection. Selecting the correct range of acoustic intensity for the

application is one of the priorities 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. This Samsung Medison system provides both automatic and

user-definable settings.

Output has a direct impact on acoustic intensity. Once the application has been

established, the output control can be used to increase or decrease the

intensity output. The output control allows you to select intensity levels less than

the defined maximum. Prudent use ensures good image quality while

employing the lowest output intensity.

▐ Indirect Controls

The indirect controls are those that have an indirect effect on the acoustic

intensity. These controls affect the 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 scanned 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

2 - 30 RS80A Service Manual

beam is only concentrated on a given area for a fraction of the time necessary

in an 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

is, the higher the number of pulses of energy that will be emitted will be, in the

given period of time. Pulse repetition frequency is affected by a number of

controls, including 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. Maintaining or

increasing the resolution at a different focal zone involves the adjustment of

numerous outputs from the focal zone. This output adjustment is one of the

system’s optimization features. 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

greater output intensity to scan at a deeper 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,

Chapter 2. Safety 2 - 31

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-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 of these indices is displayed is determined

by the nearest application, system settings, and choice of the user.

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 three indices, only one of

which is displayed at all times. 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 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 the 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 of application takes place. The decision

as to which of the three thermal indices to display should be based on the

following criteria:

2 - 32 RS80A Service Manual

Appropriate index for the application: TIs is used for imaging soft tissue, and TIb

for a focus at or near a bone. Certain factors such as the presence of fluid or

bone, or the flow of blood, might create artificially high or low thermal index

readings. 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. 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 bioeffects varies with peak

pressure and ultrasound frequency. The MI 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 effect 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, and mode of

operation. 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

Chapter 2. Safety 2 - 33

near the focus after the ultrasound beam has passed through soft tissue or

fluid, for example, at or near the bones of a 2 to 3 months old fetus. The

cranial bone thermal index (TIc) informs the user about the potential

heating of bone at or near the surface, 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 at Utility > Setup > Display > Display.

 Mechanical and Thermal indices Display Precision and Accuracy

The system expresses the precision of MI and TI in units of 0.1.

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 variability range of probes and systems, inherent acoustic output

modeling errors and measurement variability, 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

of the tissue or organs in question. 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 applied to

algorithms to calculate 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 the

measurement and calculation process. For example:The measured water

tank values are de-rated 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

2 - 34 RS80A Service Manual

perfusion rates, blood heat capacity, and tissue thermal conductivity were

selected.

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,

measurement variability and variability among probes and systems are

significant factors. 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, and variability 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 variability ranges of

probes and systems, inherent acoustic output modeling errors, and

measurement variability. Display accuracy estimates are measured

according to AIUM measurement standards but not based on errors caused

during the measurement. They are also independent of the effects of non-

Chapter 2. Safety 2 - 35

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 values.

 Power

The power controls the system’s acoustic output. Two real-time output

values are on the screen: a TI and a 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.

▐ D Mode Controls

 2D Mode Size

Narrowing the sector angle may increase the frame rate. This will increase

the TI. Pulse voltage may be automatically adjusted down with 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 frame rate. This will

increase the TI. The number of focal zones may also increase

automatically to improve resolution. This action may change MI since the

peak intensity can occur at a different depth.

2 - 36 RS80A Service Manual

 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 frame rate or

focal depth automatically. Lower frame rates decrease the TI. 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.

▐ Color and Power Controls

 Color Sensitivity

Increasing the color sensitivity increases TI and the time spent for scanning

color images. Color pulses are the dominant pulse type in this mode.

 Color Sector Width

Narrower color sector width will increase the color frame rate, and so 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

select a new color focal zone or color pulse length. The TI will change due

to the combination of these effects. Generally, the TI 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

Chapter 2. Safety 2 - 37

TI change will be small.

 Scale

Using the SCALE control to increase the color velocity range may increase

the TI. The system will be automatically adjusted to maintain pulse voltage

below the system maximum. A decrease in pulse voltage will decrease the

MI.

 Sector Width

A narrower 2D Mode sector width in Color imaging will increase color frame

rate. The TI will increase. 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.

 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.

2 - 38 RS80A Service Manual

▐ 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 MI is the MI 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. Settings are initialized when you select

a probe. Samsung Medison's factory defaults vary with probe, application

and mode. Defaults that are below the FDA limits have been chosen 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 will also automatically

choose a deeper 2D-mode focal depth. A change of focal depth will 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. Samsung

Medison's factory defaults vary with probe, application and selected mode.

Defaults that are below the FDA limits have been chosen for intended use.

▐ Related Guidance Documents

For more information on ultrasonic bioeffects and related topics, refer to the

following:

- AIUM Report, January 28, 1993, “Bioeffects and Safety of Diagnostic

Ultrasound”

Chapter 2. Safety 2 - 39

- 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 (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J

Ultrasound Med., Sept. 1988: 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 January 28, 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

2 - 40 RS80A Service Manual

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)

▐ 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 not 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 and the In Situ value have been estimated by using the following

formula:

)23.0( alf



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

e

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

commonly reported In Situ value uses the following formula:



In Situ (derated) = Water

e

)069.0( lf

Since this value is not the true In Situ intensity, the term “derated” is used.

The maximum derated and the maximum water values do not always occur

Chapter 2. Safety 2 - 41

under the same operating conditions. 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 has the greatest water value intensities in

its deepest zone. The same transducer may have its largest de-rated intensity in

one of its shallowest focal zones.

▐ 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,

(MI@ISPPA.3) may be reported instead of MI (global maximum
value) if ISPPA.3 is 190W/cm

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 operational condition giving

rise to ISPTA.3, WO is the total time-average power. For operational
condition to be reported as ISPPA.3 or less, WO is the Ultrasonic
power associated with the transmit pattern that gives rise to value
that is reported as ISPPA.3 or less.

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).

2

.

2 - 42 RS80A Service Manual

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).

▐ Acoustic Measurement Precision and Uncertainty

The Acoustic Measurement Precision and Acoustic Measurement Uncertainty

are described below.

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 %

 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.

Chapter 2. Safety 2 - 43

- Oscilloscope offset accuracy.

- Oscilloscope clock accuracy.

- Oscilloscope Digitization rates.

- Noise.

The acoustic power measurements using systemic uncertainties radiation force

are measured by using calibrated NIST acoustic power sources.

We also recommend 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).

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.

2 - 44 RS80A Service Manual

▐ 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.

Protecting the Environment

■ To dispose of the system or accessories that have come to

the end of their lifespan, contact the vendor or follow
appropriate disposal procedures.

Chapter 2. Safety 2 - 45

CAUTION

■ You are responsible for complying with the relevant

regulations for waste disposal.

■ The lithium ion battery used in the product must be
replaced by aSamsung Medison service engineer or an
authorized dealer.

Chapter 3

Installing the Product

Transporting ..................................................................................... 3

Unpacking the Product .................................................................... 5

Installation Environment ................................................................. 8

How to install the Product ............................................................... 9

System Power ................................................................................ 15

System Settings ............................................................................. 17

System General Setting ............................................................... 18

Display ......................................................................................... 23

Annotate ...................................................................................... 26

Peripheral Device Settings........................................................... 31

User Defined Keys ....................................................................... 34

Miscellaneous .............................................................................. 37

Options ........................................................................................ 42

DICOM Settings ........................................................................... 44

AutoCalc ...................................................................................... 59

About ........................................................................................... 60

Chapter 3. Installing the Product 3-3

Transporting

This product is a finely tuned piece of medical electronic equipment; careful
attention is required when transporting it.

▐ Caution on Transporting

The box packaging is designed to reduce impact. However, excessive shock
such as the product falling over may seriously damage the product.

The product weighs more than 100kg. Be extra careful when

WARNING

 Before transporting the product, make sure that the brakes on the wheels are

unlocked. Also, be sure to retract the monitor arm completely so that it is
secured in a stationary position.

transporting it. Careless transportation of the product may
result in product damage or personal injury.

 Always use the handles at the back of the console and move the product

slowly.

▐ Brake

Use the brake to control the movement of the product. The brake is located at
the center of the footplate; you can control all wheels at once by using the
footplate.
To lock the brakes, press the front part of the brake with your foot. To unlock the
brakes, press the back of the pedal.

We recommend that you lock the brakes when using the product.

▐

Precautions on Ramps

Always make sure that the control panel is facing the direction of movement. If
you leave the product on an incline, the product may fall over even if the brakes
are engaged. Avoid leaving the product on an incline.

3 - 4 RS80A Service Manual

Be aware of the castors, especially when moving the

WARNING

system. It is recommended that you practice beforehand
before climbing up or down an incline.

▐ 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.

Category Temperature OC Humidity %

Transporting -25 ~ 60 20 ~ 90

Storage -10 ~ 50 20 ~ 90

Operating 10 ~ 35 30 ~ 75

[Table 3-1. The Product’s Humidity and Temperature Tolerance]

Chapter 3. Installing the Product 3-5

Unpacking the Product

Dismantling the Product Box

1. Dismantle 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]

Accessories

A box containing various accessories is supplied with the product. If it is not
consistent with your order, please contact the Samsung Medison customer service
department or your local vendor.

3 - 6 RS80A Service Manual

Disengaging Locking Mechanisms

When this product is being transported, the monitor arm and the control panel are
secured in place with locking mechanisms to ensure safety. Disengage the locking
mechanisms before using the product by following the procedure shown below.

▐ Monitor Arm

1. Press down the locking mechanism in the middle of the monitor arm to
disengage the lock.

▐ Control Panel

1. Loosen the four screws under the control panel to disengage the lock.

Chapter 3. Installing the Product 3-7

2. Remove the rubber from the top grill of the rear vent. Release the manually
operated lever from its current position (right) to secure the control panel in
place.

3 - 8 RS80A Service Manual

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.

Placing the system near generators, X-ray machines or

CAUTION

 Optimal conditions for the system are a temperature of 10-35 and a humidity of

30-75%.

 Avoid excess humidity.

broadcast cables may result in screen noise and abnormal
visual images. Sharing the power source with other electrical
devices may also cause noise.

 Avoid direct sunlight.

 Avoid excessive fluctuations in temperature.

 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.

Chapter 3. Installing the Product 3-9

①

②

How to install the Product

Installation Safety

Power receptacle and equipotential terminal are located at the rear of product.

[Figure 3.2 Power Receptacle and Equipotential Terminal]

① Power inlet: Accepts the power cord, which connects to an external power

supply.

② Equipotential terminal: Must be connected to the equipotential bonding in a

treatment room.

3 - 10 RS80A Service Manual

▐ 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.

NOTE

The product may ship with the power cable connected to
the console.

 If the product needs to be transported or stored for an

extended duration, the temperature and humidity of the

CAUTION

Refer to “[Table 3-2. Operational Temperature of Product]” before turning the

product on

.

environment must be checked.

 A sudden change in temperature may cause

condensation and lead to product failure.

TemperatureC

Waiting time
Hour

-20 -15 -10 -5 0 5 10 ~ 35 45 50 55 60

16 10 8 6 4 2

[Table 3-2. Operational Temperature of Product]

Use

immediately

2 4 6 10

▐ Connecting the Equipotential Terminal

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. Equipotential terminal of a medical equipment should be

connected to the equipotential bonding network in medical rooms as shown in

the picture.

Chapter 3. Installing the Product 3-11

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.
Up to four (five including CW) probes may be connected. The CW probe
should only be connected to its own connector.

2. To mount, turn the connector turning handle clockwise.

[Figure 3.3 Probe Connector]

3 - 12 RS80A Service Manual

Connecting Peripherals

 Do not install peripheral devices that are not listed in this

manual within the patient environment. If you install an
unlisted device in the patient environment, it may cause an

CAUTION

electrical hazard.

 Do not connect additional peripheral devices to socket of the

auxiliary socket. Doing so may decrease the safety level.

[Figure 3.4 Patient Environment]

NOTE

For more information on the recommended peripheral devices,
refer to “Chapter 1. Introduction”.

▐ Internal Peripheral Devices

These are peripheral devices mounted inside the system.

 DVD-Multi

DVD-RW, DVD+RW, DVD-R, DVD+R, CD-R, CD-RW, CD-ROM

 Hard Disc Drive

Min. 64Gbytes SATA SSD

Chapter 3. Installing the Product 3-13

▐ External Peripheral Devices

External peripherals are mounted when their use is desired by the user; they
are usually connected via appropriate ports on the Rear Panel.

 When using a peripheral device via a USB port, always turn

the power off before connecting/disconnecting the device.
Connection/disconnection of USB devices while the power is

CAUTION

NOTE

on may lead to malfunction of the system and the USB
devices.

 Do not connect additional peripheral devices to socket of the

auxiliary socket. Doing so may decrease the safety level.

 Use Utility > Storage Manager to mount or dismount a

removable disk.

 If you are using USB 1.1 flash memory, the system may fail

to recognize the device. Remove the flash memory from the
console and equip again with an appropriate device.

 USB Video Printer

The following products are recommended:

- BW: Mitsubishi P-95DE, Sony UP-D897, Samsung ML-2955DW

- Color: Mitsubishi CP-30DW, Sony UP-D25MD, Samsung CLP-615ND

CAUTION

■ You must install a printer and drivers that are compatible
with the English version of Microsoft Windows 7
Contact Samsung Medison customer support division for
inquiries about printer driver installation.

■ When connecting a printer, make sure that it is the same
as the printer that is configured in Microsoft WindowsTM or
Setup.

■ Please note that different printers are connected via
different ports. Printers should be connected to the printer
port while the USB printer should be connected to the USB
port.

TM

.

3 - 14 RS80A Service Manual

 USB to RS-232C Serial Cable

 Foot Switch

 Other: Flash Memory Media

Chapter 3. Installing the Product 3-15

System Power

Boot up the system for use.

Make sure to connect the probes and peripheral devices that

CAUTION

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.

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

NOTE

Before starting the diagnosis, you must register the patient
information.

 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.

3 - 16 RS80A Service Manual

Shutting Down the System

Press the On/Off button while using the system to initiate shutdown. Press Shut
Down on the screen to shut down the system, or press Cancel to cancel.

 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

CAUTION

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.

Chapter 3. Installing the Product 3-17

System Settings

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. Tap the Setup button on the touch screen.

2. The Setup screen will appear on the monitor and the touch screen. Select

a tab that has items to specify.

※ 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.

3. Specify settings for each item.

4. Save and close the settings. Click OK on the monitor screen, or tap Exit
on the touch screen, or press Exit button on the control panel to switch to
Scan mode.

5. Tap Return on the touch screen to go back to the Utility screen.

[Figure 3.5 Setup - Touch Screen]

3 - 18 RS80A Service Manual

System General Setting

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 3.6 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.

Chapter 3. Installing the Product 3-19

NOTE

 Department

Enter details about the medical institution or the organization. This
information is used to identify information transferred via DICOM.

 Date

The current date is displayed. To change the date, click .

NOTE

※Tip! How to set the date and time

1. Click next to the Date (or Time) field.

You cannot input the following characters: #, [, ", :, ?, |,
\, "

 You cannot change the date and time when a

patient ID has been registered. To change the date
and time, you should finish the current diagnosis by
tapping the End Exam button on the touch screen.

 You can select a year from 2006 to 2027.

2. Set the date and time using the trackball and the Set button on
the control panel.

3. If it is properly set, press Apply to apply changes. To close the
date and time setting window, press OK. To cancel, press
Cancel.

[Figure 3.7 Date & Time]

3 - 20 RS80A Service Manual

 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.

▐ 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

- Prospective: When the Store Clip button is pressed during scanning,
the subsequent images are saved.

- Retrospective: When the Store Clip is pressed during scanning, the
previous images are saved.

NOTE

To configure the Store Clip button, go to Utility >
Setup > User Defined Key > User Key Setup.

▐ 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.

▐ Scan 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

Chapter 3. Installing the Product 3-21

- Allow B/C/PW: Select this if you wish to use simultaneous mode for
both 2D/PW and for 2D/C/PW.

 Dual Mode

Select whether to activate the Change window in Dual Mode.

 Dual Live

Select the position of the Color Doppler Mode in Dual Live Mode.

- Left / Top: Color Doppler Mode is located in the left or upper part of the
screen.

- Right / Bottom: Color Doppler Mode is located in the right or lower part
of the screen.

- Dual Live Left-Right Dual Only: The Top-Bottom Dual button
disappears when you check this checkbox.

 Freeze Action

Select a function to execute when the Freeze button on the control panel is
pressed. Available options are BodyMarker, Caliper, Measure, AutoCalc,
and None.

- D or M Mode Only: When the Freeze Action is set to Measure,
Measure Freeze Action will function only in Doppler and M Modes.

3 - 22 RS80A Service Manual

 End Exam Action

- End Exam Only: Tapping the End Exam button on the touch screen
exits Exam Mode and switches the screen to the B Mode Scan screen.

- End Exam + Patient: Tapping the End Exam button on the touch screen

switches the screen to the Patient Information screen.

- End Exam + New Exam: Tapping the End Exam button on the touch

screen switches the screen to the Patient Information screen, and

automatically generates an ID.

- Reset Preset: If this checkbox is checked, the Preset will be reset when
you tap the End Exam button.

 Option

You can select multiple items. Use the trackball and the Set button to
select and check or uncheck an item.

- Auto Freeze: Scan mode is frozen automatically when the product is
not used for 10 minutes.

※Tip!

The Scan Mode is frozen automatically, regardless of Auto Freeze setting,
when the product is not used for 1 hour.

NOTE

In Live 3D Mode, Auto Freeze is activated when the
product is not used for 20 minutes.

- HPRF: 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: 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.