Samsung SonoAce R3 Service manual

ENGLISH
Document No. CSD-SMESAR3
Revision 01

CopyrightⓒSAMSUNG MEDISON Co., L TD.

SSaaffeettyy RReeqquuiirreemmeennttss

Classifications:

- T ype of protection against electrical shock: Class I

- Degree of protection against electrical shock (Patient connection):T ype BF equipme nt

- Degree of protection against harmful ingress of water: Ordinary equipment

- Degree of safety of application in the presence of a flammable anesthetic material with
air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide.

- Mode of operation: Continuous operation

Electromechanical safety standards met:

- IEC/EN 60601-1 Medical Electrical Equipment, Part 1General Requirements for Safety.

- IEC/EN 60601-1-1 Safety requirements for medical electrical sy stems.

- IEC/EN 60601-1-2 Electromagnetic compatibility -Requi rements and te sts.

- IEC/EN 60601-2-37 Particular requirements for the safety of ultrasonic medical

diagnostic and monitoring equipment.

- IEC 61 157 Declaration of acoustic output p arameters.

- ISO 10993-1 Biological evaluation of medical devices.

- UL 60601-1 Medical Electrical Equipment , Part 1 General Requirements for Safety.

- CSA 22.2, 601.1 Medical Electri cal Equipment, Part 1 General Requirement s for
Safety .

Declarations:

0123

This is CSA symbol for Canada and United States of America

This is manufacturer’s declaration of product compliance
with applicable EEC directive(s) and the European notified
body.

This is manufacturer’s declaration of product compliance
with applicable EEC directive(s).

This is GMP symbol for Good Manufacturing Practice of
Korea quality system regulation.

RREEAADD TTHHIISS FFIIRRSSTT

Before asking for the product to be repaired, read this service manual thoroughly, learn
how to troubleshoot, and make sure you understand the precautions fully.

The repair of the system and the replacement of parts must be carried out by an authorized
dealer or the customer service department of SAMSUNG MEDISON Co., Ltd.

The company is shall not be held liable for any injury and damage caused by not
following this warning.

For safe use of this product, you should read ‘Chapter 2. Safety’ in this manual, prior to
starting to

useing this system.

˙˙˙˙˙˙˙˙˙˙˙

DDAANNGGEER

˙˙˙˙˙˙˙˙˙˙˙˙˙

WWAARRNNIINNG

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

˙˙˙˙˙˙˙

NNOOTTE

˙

R

Describes precautions necessary to prevent user hazards of great urgency.
Ignoring a DANGER warning will risk life-threatening injury.

˙

G

Used to indicate the presence of a hazard that can cause serious personal injury,
or substantial property damage.

˙

N

Indicates the presence of a hazard that can cause equipment damage.

˙

E

A piece of information useful for installing, operating and maintaining a system.
Not related to any hazard.

Contents

Chapter 1. General Information

1.1 Overview ....................................................................................................... 1-1

1.2 Features and Advantages of SonoAce R3 .................................................. 1-2

1.3 Product Configuration .................................................................................... 1-3

1.3.1 Console ......................................................................................... 1-3

1.3.2 LCD Monitor ................................................................................. 1-4

1.3.3 Control Panel ................................................................................ 1-5

1.3.4 Probe ............................................................................................ 1-5

1.4 Specifications .................................................................................................. 1-6

Chapter 2. Safety

2.1 Overview ....................................................................................................... 2-1

2.2 Safety-Related Information ............................................................................ 2-2

2.2.1 Safety Symbols ............................................................................ 2-2

2.2.2 LABEL ........................................................................................... 2-3

2.3 Electrical Safety .............................................................................................. 2-4

2.3.1 Prevention Electric Shock ........................................................... 2-4

2.3.2 ESD ............................................................................................... 2-4

2.3.3 EMI ................................................................................................ 2-5

2.3.4 EMC .............................................................................................. 2-5

2.4 Mechanical Safety .......................................................................................... 2-11

2.4.1 Moving Equipment ....................................................................... 2-11

2.4.2 Safety Note ................................................................................... 2-11

2.5 Biological Safety ............................................................................................. 2-12

2.5.1 ALARA Principle .......................................................................... 2-12

2.6 Environmental Protection .............................................................................. 2-24

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Contents

Chapter 3. Installing the Product

3.1 Overview ....................................................................................................... 3-1

3.2 Transportation ................................................................................................ 3-3

3.2.1 Precautions for Transportation .................................................... 3-3

3.2.2 Temperature and Humidity ......................................................... 3-3

3.3 Unpacking ....................................................................................................... 3-4

3.3.1 Unpacking the Box ....................................................................... 3-4

3.3.2 Checking Package contents ....................................................... 3-5

3.4 Precautions for Installation ............................................................................ 3-6

3.4.1 Precautions ................................................................................... 3-6

3.5 Installations Procedure .................................................................................. 3-7

3.5.1 Installation Safety ......................................................................... 3-7

3.5.2 Connecting the Power Cord ........................................................ 3-8

3.5.3 Connecting the Network Cable ................................................... 3-9

3.5.4 Connecting the Probe .................................................................. 3-9

3.6 Starting the Product ....................................................................................... 3-10

3.7 Shutting down the Product ............................................................................ 3-11

3.8 Connecting the Peripherals ........................................................................... 3-12

3.8.1 External Peripherals .................................................................... 3-12

3.9 System Setting ............................................................................................... 3-14

3.9.1 General System Setup ................................................................ 3-14

3.9.2 Display Setup ............................................................................... 3-16

3.9.3 Misc ............................................................................................... 3-18

3.10 Measure Setting ............................................................................................. 3-19

3.10.1 General ......................................................................................... 3-19

3.10.2 Doppler ......................................................................................... 3-20

3.10.3 Report ........................................................................................... 3-21

3.10.4 OB ................................................................................................. 3-22

3.10.5 Fetal Echo .................................................................................... 3-25

3.10.6 Cardiac.......................................................................................... 3-26

3.10.7 Urology.......................................................................................... 3-26

3.10.8 Vascular ........................................................................................ 3-27

3.11 Setting DICOM ( Optional ) ............................................................................ 3-28

3.11.1 Setting DICOM Information ......................................................... 3-28

3.11.2 Network Setup .............................................................................. 3-29

3.11.3 Adding or Changing the DICOM Server .................................... 3-29

3.11.4 Editing the DICOM Server ........................................................... 3-32

3.11.5 Deleting DICOM Server ............................................................... 3 - 3 2

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3.11.6 Testing DICOM Server ................................................................ 3-32

3.11.7 DICOM Log .................................................................................. 3-32

3.12 Setting Option ................................................................................................. 3-34

3.13 Setting Peripheral Devices ............................................................................ 3-35

3.13.1 Video Out Type ............................................................................ 3-35

3.13.2 Foot Switch ................................................................................... 3-35

3.13.3 Printer 1 ........................................................................................ 3-35

3.13.4 Printer 2 ........................................................................................ 3-35

3.14 Information ...................................................................................................... 3-36

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Contents

Chapter 4. Checking the Product

4.1 Overview ..................................................................................................... 4-1

4.2 Starting the Product ....................................................................................... 4-2

4.3 Monitor ....................................................................................................... 4-3

4.3.1 Monitor Display ............................................................................ 4-3

4.4 Control Panel .................................................................................................. 4-5

4.4.1 Detail Control Panel ..................................................................... 4-6

4.4.2 Soft Menu ..................................................................................... 4-8

4.4.3 Keyboards .................................................................................... 4-9

4.5 Checking the Performance .......................................................................... 4-11

4.5.1 Basic Check ................................................................................. 4-11

4.5.2 Detail Check ................................................................................. 4-12

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Contents

제5장 제품 구조

5.1 개요 5-1

5.2 System Block Diagram .................................................................................. 5-3

5.3 EKO7의 기본 구조 ........................................................................................ 5-4

5.3.1 개요 ............................................................................................... 5-4

5.3.2 Ultrasound System Part .............................................................. 5-4

5.3.3 PC Part ......................................................................................... 5-5

5.3.4 User Interface Part ....................................................................... 5-5

5.3.5 AC to DC Power Module ............................................................. 5-5

5.4 PSA 5-6

5.5 Beamformer Board ......................................................................................... 5-8

5.6 CW Board 5-11

5.7 Back End Board ............................................................................................. 5-14

5.8 PCI Board 5-18

5.9 DVI Board 5-19

5.10 VGA Card 5-21

5.11 VCRIN Board .................................................................................................. 5-22

5.12 PC Mother Board ........................................................................................... 5-23

5.13 Software DSC ................................................................................................. 5-24

5.14 LCD IF Board .................................................................................................. 5-26

5.15 Rear Board ..................................................................................................... 5-27

5.16 Control Panel .................................................................................................. 5-28

5.17 Power Supply ................................................................................................. 5-30

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Contents

Chapter 6. Basic Maintenance

6.1 Overview ....................................................................................................... 6-1

6.2 System Information ........................................................................................ 6-2

6.3 Admin Mode ................................................................................................... 6-3

6.3.1 Entering Admin Mode .................................................................. 6-3

6.3.2 Admin Mode Functions................................................................ 6-4

6.4 Upgrade . .................................................................................................... 6-6

6.4.1 Software Upgrade ........................................................................ 6-6

6.4.2 Hardware Upgrade ...................................................................... 6-9

6.5 Backup & Restore .......................................................................................... 6-10

6.5.1 Backup User Setting .................................................................... 6-10

6.5.2 Restore User Setting ................................................................... 6-12

6.6 Adding and Deleting Options......................................................................... 6-14

6.6.1 Option type ................................................................................... 6-14

6.6.2 Registering Option ....................................................................... 6-14

6.7 Control Panel .................................................................................................. 6-16

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Contents

Chapter 7. Troubleshooting

7.1 Overview ....................................................................................................... 7-1

7.2 Power ....................................................................................................... 7-2

7.2.1 Power Failure ............................................................................... 7-2

7.2.2 Power cannot turned off .............................................................. 7-2

7.2.3 Power is automatically turned off ................................................ 7-2

7.3 Monitro ....................................................................................................... 7-3

7.3.1 Blank Screen ................................................................................ 7-3

7.3.2 Screen Color Abnomal ................................................................ 7-3

7.4 Error Messages .............................................................................................. 7-4

7.4.1 System hangs after an error during booting............................... 7-4

7.4.2 System works even if error occurred .......................................... 7-4

7.5 Image ....................................................................................................... 7-5

7.5.1 No BW Image Echo & No BW Mode Image Format ......................... 7-5

7.5.2 Noise Link Rain over the BW Mode Image (Noise) ........................... 7-5

7.5.3 PW & Color Doppler Mode Trouble ................................................... 7-5

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Contents

Chapter 8. Disassembly and Reassembly

8.1 Overview ....................................................................................................... 8-1

8.2 Disassembly and Reassembly of the Body Cover ...................................... 8-3

8.2.1 Preparations ................................................................................. 8-3

8.2.2 Body Rear & Middle Cover ......................................................... 8-3

8.2.3 Disassembly of the Main Part and LCD/Control Panel ............. 8-4

8.3 Disassembly and Reassembly of the Main System Part ............................ 8-5

8.3.1 Preparations ................................................................................. 8-5

8.3.2 Power & HDD & Side Fan ........................................................... 8-5

8.3.3 PSA & Rear & Rear Fan & Handle ............................................. 8-6

8.3.4 LCD & Inverter & USB Board ...................................................... 8-7

8.4 Disassembly and Reassembly of the Control Panel ................................... 8-8

8.4.1 Preparations ................................................................................. 8-8

8.4.2 Disassembly Control Panel and LCD ......................................... 8-8

8.4.3 Control Panel ................................................................................ 8-9

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Contents

Chapter 9. Probe

9.1 Overview ....................................................................................................... 9-1

9.2 Probe List ....................................................................................................... 9-2

9.3 Thermal Index (TI Table) ............................................................................... 9-5

9.4 Ultrasound Transmission Gel ........................................................................ 9-6

9.5 Sheaths ....................................................................................................... 9-7

9.6 Probe Precautions .......................................................................................... 9-9

Chapter 10. User Maintenance

10.1 Overview ....................................................................................................... 10-1

10.2 System Maintenance ..................................................................................... 10-2

10.2.1 Installation Maintenance .............................................................. 10-2

10.2.2 Cleaning and Disinfections .......................................................... 10-2

10.2.3 Fuse Replacement ...................................................................... 10-3

10.2.4 Accuracy Check ........................................................................... 10-4

10.3 Administration of Information ......................................................................... 10-5

10.3.1 User Setting Back-up ................................................................... 10-5

10.3.2 Patient Information Back-up ........................................................ 10-5

10.3.3 Software ........................................................................................ 10-5

Chapter 11. Service Part List

11.1 Overview ....................................................................................................... 11-1

11.2 Body Cover ..................................................................................................... 11-2

11.3 Ultrasound System Part ............................................................................... 11-4

11.4 LCD Part ....................................................................................................... 11-5

11.5 PC Part ....................................................................................................... 11-6

11.6 Power Part ...................................................................................................... 11-8

11.7 User Interface Part ......................................................................................... 11-9

11.8 ETC Part ................................................................................................. 11-10

11.9 Options ................................................................................................... 11-11

11.10 Probes ................................................................................................... 11-12

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CChhaapptteerr 11.. GGeenneerraall IInnffoorrmmaattiioonn

1.1 Overview

Chapter 1 contains the informatio n nece ssary to pl an the Tr oubles hooting of
SonoAceR3.

The SonoAceR3 is a high-resolution color ultrasound scanner with high penetration
and a variety of measurement fu nctions.

Contents

1.1 Overview ....................................................................................................1-1

1.2 Features and Advantages of SonoAceR3 ...............................................1-2

1.3 Product Configuration ...............................................................................1-3

1.3.1 Console ....................................................................................1-3

1.3.2 LCD Monitor ............................................................................1-4

1.3.3 Control Panel ...........................................................................1-5

1.3.4 Probes......................................................................................1-5

1.4 Specifications .............................................................................................1-6

Chapter 1. General Information 1-1

1.2 Features and Advantages of SonoAceR3

z High-end Digital Beamforming : The SonoAce R3 utilize s the ne wly

developed Digital Beam fo rming te chnolo gy.

z A variety of applications : The SonoAceR3 is optimized for use in a variety

of ultrasound departments, cardiac, vascular, abdomen, Obsterics, Urology,
Gynecology.

z Various diagnostic Modes : 2D Mode, M Mode, Color Doppler Mode, Power

Doppler Mode, PW Spectral Doppler Mode, etc.

z Measurement and Report Functions : Besides the basic distance, area,

circumference and volume measurement functions, the SonoAceR3 also
provides application-specific measurement functions. The report function
collates measurement data.

z Review of Scanned Images : The SonoAceR3 displays Cine images of 512

frames and loop images of 4096 lines.

z SonoViewTM : This is a total ultrasound image management system, which

allows a user to archive, view and exchange documents.

z Digital Imaging and Communication in Medicine (DICOM) Function : This is

used to archive, transmit and print DICOM images through a network.

z Peripheral/Accessory Connection : A variety of peripheral devices including

VCRs and printers can be easily connected to the SonoAceR3.

Chapter 1. General Information 1-2

1.3 Product Configuration

This Product consists of the monitor, the control panel, the console and, the probes
and the cart(optional).

1.3.2 Console

The console consists of two parts – the in ner unit and the outer unit .
The interior of the console mainly contains devices that produce ultrasound images.
The outside of the console consists of various connection ports and handles.

Handle

[Figure 1-1] Console of SonoAce R3

LCD Monitor

Control Panel

Chapter 1. General Information 1-3

1.3.2 LCD Monitor

The monitor of this system is a colo r VGA monito r, which di splays ultr asound im ages
and additional information. This monitor is connected to the main body through a
central pivot, allowing it to be tilte d to the optimal vi ewing an gle.

Probe Connector

[Figure 1-2] Front and Back of SonoAce R3

[Figure 1-3] LCD Monitor

Chapter 1. General Information 1-4

1.3.3 Control Panel

The control panel can be used for cont rolling th e system.

Alpha-Numeric

Button

Dial Button

Track Ball

Slide Volume

1.3.4 Probe

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

[Figure 1-4] Control Panel

˙

˙˙˙˙˙˙˙

E

NNOOTTE

For more information, refer to ‘Chapter 9. Probes’.

Chapter 1. General Information 1-5

1.3.5 SonoAceR3 Cart (Optional)

The SonoAce R3 System can be placed on a cart during use or for transport. For
more information on installing and using the SonoAce R3, please refer to the
installation guide that come s with it.

[Figure 1-5] SonoAce R3 Cart

Chapter 1. General Information 1-6

1.4 Specifications

Height: 375mm (with handle)

Physical Dimensions

Imaging modes

Gray Scale 256 (8 bits)

Focusing

Width: 402mm (with probe holder)
Depth: 188mm(with control panel)
Weight: More than 8.7kg

2D real-time
Dual 2D real-time
2D/M-mode
Power Doppler
Color Doppler for Option
Pulsed-wave Doppler for Option
3D-mode (Freehand) for Option
Simultaneous

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

Curved Linear Array : C2-4/20, CN2-8, CN4-9

Probes

Probe connections

Monitor 15 inch LCD monitor

Rear Panel
Input/Output
Connections

Image Storage

Application

Linear Array : L5-12/60, LN5-12/4 0
Endocavity Curved Linear Array : EC4-9

One probe connectors
Two probe connectors for option

USB 3ports
LAN(10/100 BASE-T)
DVI Output
BW Printer remote control
BW Output
S-VHS Output
Sound Output

Maximum 512 frames for CINE memory
Maximum 4096 Lines for LOOP memory
Image filing system

Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small
Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Neonatal,
Cardiac

Electrical Parameters 100-120V/200-240V, 250VA, 50/60Hz

Chapter 1. General Information 1-7

Automatic Calculation
and Quantification

Signal processing
(Pre-processing)

Signal processing
(Post-processing)

Obssterics
Gynecology
Cardiology
Fetal Echo
Vascular
Urology
*Refer the Chapter 5 for additional information

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
HD zoom

Frame average
Gamma-scale windowing
Image orientation (left/right and up/down, rot ation)
White on black/black on white

Trackball operation of multiple cursors
2D mode: Linear measurements and area measurements

Measurement

using elliptical approximation or trace
M mode: Continuous readout of distance, time, and slope rate
Doppler mode: Velocity and trace

Black-and white printer
Color printer

Auxiliary

VCR
Monitor
Foot switch

User Interface English, German, French, S panish, Italian, Russian, Chinese

Pressure Limits

Humidity Limits

Temperature Limits

Operating: 700hPa to 1060hPa
Storage: 700hPa to 1060h Pa

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

Operating: 10
Storage & Shipping: -25

O

C ~ 35OC

O

C ~ 60OC

Chapter 1. General Information 1-8

CChhaapptteerr 22.. SSaaffeettyy

2.1 Overview

Chapter 2 contains the information necessary to Safety

Please read this chapter before using the SAMSUNG MEDISON ultrasound
system. It is relevant to the ultrasound system, the probes, the recording devices,
and any of the optional equipment.

SonoAce R3 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 the medical device.

Contents

2.1 Overview ....................................................................................................2-1

2.2 Safety – Related Information ....................................................................2-2

2.2.1 Safety Symbols .......................................................................2-2

2.2.2 LABEL ......................................................................................2-3

2.3 Electrical Safety .........................................................................................2-4

2.3.1 Prevention Electric Shock ......................................................2-4

2.3.2 ESD ..........................................................................................2-4

2.3.3 EMI ...........................................................................................2-5

2.3.4 EMC .........................................................................................2-5

2.4 Mechanical Safety ................................................................................... 2-11

2.4.1 Moving Equipment ................................................................ 2-11

2.4.2 Safety Note ............................................................................ 2-11

2.5 Biological Safety ..................................................................................... 2-12

2.5.1 ALARA Principle ................................................................... 2-12

2.6 Environmental Protection....................................................................... 2-24

Chapter 2. Safety 2-1

2.2 Safety – Related Information

2.2.1 Safety Symbols

The International Electro Technical Commission (IEC) has established a set of

symbols for medical electronic equipment, which classifies a connection or warn
of potential hazards. The classifications and symbols are shown below.

Symbols Description

Power switch (Supplies/cuts the power for product).

Indicates a caution for risk of electric shock.

Indicates dangerous voltages over 1000V AC or over

1500V DC.

Warning, Caution

AC (alternating current) voltage source

Print remote output

Electrostatic discharge

Protection against the effects of immersion.

Protection against dripping water.

Probe connector

Isolated patient connection (Type BF applied part).

Network port

Output port ( DVI, RGB, B/W, S-VHS, SOUND )

Chapter 2. Safety 2-2

2.2.2 LABEL

To protect the system, you may see ‘Warning’ or ‘Caution’ marked on the
surface of the product

[Figure 2-1]Marked on the product

Chapter 2. Safety 2-3

2.3 Electrical Safety

This equipment has been verified as a Class I device with Type BF applied parts.

2.3.1 Prevention of Electric Shock

Additional equipment connected to medical electrical equipment must comply with
the respective IEC or ISO standards (e.g. IEC 60950 for data processing
equipment). Furthermore all configurations shall comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3 Ed. of IEC
60601-1, respectively). Anybody connecting additional equipment to medical
electrical equipment configures a medical system and is therefore responsible
that the system complies with the requirements for medical electrical systems.

Attention is drawn to the fact that local laws take priority over the abovementioned
requirements. If in doubt, consult your local representative or the technical service
department.

˙˙˙˙˙˙˙˙˙˙˙˙˙

WWAARRNNIINNG

z Electric shock may exist result if this system, including and all of its externally mounted

recording and monitoring devices, is not properly grounded.

z Do not remove the covers on the system; hazardous voltages are present inside. Cabinet

panels
must be made by a qualified SAMSUNG MEDISON Customer Service Department

z Check the face, housing, and cable before use. Do not use, if the face is cracked, chipped, or

torn, the housing is damaged, or if the cable is abraded

z Always disconnect the system from the wall outlet prior to cleaning the system.

z All patient contact devices, such as probes and ECG leads, must be removed from the patient

prior to application of a high voltage defibrillation pulse

z The use of flammable anesthetic gas or oxidizing gases (N20) should be avoided.

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

z The system has been designed for 100-120VAC and 200-240VAC; you should select the

input
that the voltage indicated on the power cord matches the voltage rating of the OEM device

z An isolation transformer protects the system from power surges. The isolation transformer continues

to operate when the system is in standby

z Do not immerse the cable in liquids. Cables are not waterproof.
z The operator does not contact the parts (SIP/SOP) and the patient simultaneously.

˙

G

must be in place while the system is in use. All internal adjustments and replacements

.

.

.

˙

N

Outlet voltage of monitor, printer and VCR. Prior to connecting an OEM power cord, verify

.

.

Chapter 2. Safety 2-4

2.3.2 ESD

Electrostatic discharge (ESD), commonly referred to as a static shock, is a
naturally occurring phenomenon. ESD is most prevalent during conditions of low
humidity, which can be caused by heating or air conditioning. During low humidity
conditions, electrical charges naturally build up on individuals, creating static
electricity. 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 static shock or ESD is a
discharge of the electrical energy build-up from a charged individual to a lesser or
non-charged individual or object.

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOONN

z 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

z Always perform the pre-ESD preventive procedures before using connectors marked with the ESD

warning label

˙

.

.

- Apply anti-static spray on carpets or linoleum.

- Use anti-static mats.

- Ground the product to the patient table or bed.

z It is highly recommended that the user be given training on ESD-related warning symbols and

preventive procedures

.

[Figure 2-7] ESD symbol

2.3.3 EMI

Although this system has been manufactured in compliance with existing EMI

(Electromagnetic Interference) requirements, use of this system in the presence
of an electromagnetic field can cause momentary degradation of the ultrasound
image.

If this occurs often, SAMSUNG MEDISON suggests a review of the environment
in which the

system is being used, to identify possible sources of radiated emissions. These

emissions could be from other electrical devices used within the same room or an

adjacent room. Communication devices such as cellular phones and pagers can

cause these emissions. The existence of radios, TVs, or microwave transmission

equipment nearby can also cause interference.

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

˙

N

In cases where EMI is causing disturbances, it may be necessary to relocate this

system.

Chapter 2. Safety 2-5

2.3.4 EMC

The testing for EMC(Electromagnetic Compatibility) of this system has been
performed according to the international standard for EMC with medical devices
(IEC60601-1-2). This IEC standard was adopted in Europe as the European norm
(EN60601-1-2).

2.3.4.1 Guidance and manufacturer’s declaration - electromagnetic emission

This product is intended for use in the electromagnetic environment specified
below. The customer or the user of this product should assure that it is used in
such an environment.

Emission test Compliance Electromagnetic environment -guidance

RF Emission

(Radiation)

CISPR 11

RF Emission

(Radiation)

CISPR 11

Harmonic Emission

IEC 61000-3-2

Flicker Emission

IEC 61000-3-3

Group 1

Class B

Group 1

Class B

Class A

Complies

The Ultrasound System uses RF energy only

for its internal function. Therefore, its RF

emissions are very low and are not likely to

cause any interference in nearby electronic

equipment.

The Ultrasound System is suitable for use in all

establishments, including domestic

establishments and those directly connected to

the public low-voltage power supply network

that supplies building used for domestic

purpose.

2.3.4.2 Approved Cables, Transducers and Accessories for EMC

1) Approved Cable for Electromagnetic Compliance

Cables connected to this product may affect its emissions;

Use only the cable types and lengths listed below table.

Cable Type Length

VGA Shielded Normal

Parallel Shielded Normal

RS232C Shielded Normal

USB Shielded Normal

LAN(RJ45) Twisted pair Any

S-Video Shielded Normal
Foot Switch Shielded 2.5m
B/W Printer Unshielded Coaxial Normal

MIC Unshielded Any

Printer Remote Unshielded Any

Audio R.L Shielded Normal

VHS Shielded Normal

ECG AUX input Shielded < 3m

Chapter 2. Safety 2-6

2) Approved Transducer for Electromagnetic Compliance

The probe listed in ‘Chapter 8. Probes’ when used with this product, have
been tested to comply with the group1 class B emission as required by
International Standard CISPR 11.

3) Approved Accessories for Electromagnetic Compliance

Accessories used with this product may effect its emissions

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When connecting other customer-supplied accessories to the system, such as a
remote printer or VCR, it is the user’s responsibility to ensure the electromagnetic
compatibility of the system. Use only CISPR 11 or CISPR 22, CLASS B compliant
devices

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The use of cables, transducers, and accessories other than those specified may
result inincreased 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

IEC 60601

Test level

±6KV Contact

±8KV air

±2KV for power supply

lines

±1KV for input/output

lines

Compliance level

±6KV Contact

±8KV air

±2KV for power
supply lines
±1KV for input/
output lines

Electromagnetic environment -

guidance

Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.

Mains power quality should be that
of a typical commercial or hospital
environment.

Surge

IEC 61000-4-5

Voltage dips, short
interruptions and
voltage variations
on power supply
input lines

IEC 61000-4-11

±1KV differential mode
±2KV common mode

<5% Uт
(>95% dip in Uт)

for 0.5cycle

40% Uт
(60% dip in Uт )

for 5 cycle

70% Uт
(30% dip in Uт)

for 25 cycle

<5% Uт
(<95% dip in Uт )

for 5 s

±1KV differential mode
±2KV common mode

<5% Uт
(>95% dip in Uт)

for 0.5cycle

40% Uт
(60% dip in Uт )

for 5 cycle

70% Uт
(30% dip in Uт)

for 25 cycle

<5% Uт
(<95% dip in Uт )

for 5 s

Mains power quality should be that
of a typical commercial or hospital
environment.

Mains power quality should be that
of a typical commercial or hospital
environment. If the user of this
product requires continued
operation during power mains
interruptions, it is recommended
that this product be powered from
an uninterruptible power supply or
a battery.

Chapter 2. Safety 2-7

Power frequency
(50/60Hz)
magnetic field

3 A/m 3 A/m

IEC 61000-4-8

NOTE Uт is the a.c. mains voltage prior to application of the test level.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80MHz

3 V/m

80 MHz to 2.5GHz

0.01V

3 V/m

Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

Portable and mobile RF communications
equipment should be used no closer to any part
of the Ultrasound System, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.

Recommended separation distance

80MHz to 800MHZ

800MHz to 2.5GHz

Where P is the maximum output power rating of

the transmitter in watts (W) according to the

transmitter manufacturer and d is the

recommended separation distance in meters
(m).

Field strengths from fixed RF transmitters, as
deter-mined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range.

b

Interference may occur in the vicinity of
equipment marked with the following symbol :

a

NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile

radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Ultrasound System is used exceeds
the applicable RF compliance level above, the Ultrasound System should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Ultrasound System or using a shielded location with a higher RF shielding effectiveness and filter attenuation.

b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V

] V/m.

1

Chapter 2. Safety 2-8

2.3.4.3 Recommended separation distances between portable and mobile RF
communications equipment and the SonoAce R3

This product is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of this product
can help Prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and this product as recommended below, according to the
maximum output power of the communications equipment.

Separation distance according to frequency of transmitter [m]

Rated maximum

output power 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

For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where p is the maximum output power rating of the transmitter in

watts (W) according to the transmitter manufacturer.

NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE2) These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

150kHz to 80MHz

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

80MHz to 800MHz

800MHz to

2.5GHz

2.3.4.4 Electromagnetic environment – guidance

The Ultrasound System must be used only in a shielded location with a minimum
RF shielding effectiveness and, for each cable that enters the shielded location.
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 that the actual shielding effectiveness and filter attenuation of the

shielded location be verified to assure that they meet the minimum specification.

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If the system is connected to other customer-supplied equipment, such as a local
area network (LAN) or a remote printer, SAMSUNG MEDISON cannot guarantee
that the remote equipment will work correctly in the presence of

Chapter 2. Safety 2-9

electromagnetic phenomena.

Chapter 2. Safety 2-10

2.3.4.5 Avoiding Electromagnetic Interference

Typical interference on Ultrasound Imaging Systems varies depending on
Electromagnetic phenomena. Please refer to following table.

Imaging Mode ESD1 RF2 Power Line3

Change of operating
mode, system
settings, or system
reset.

2D or 3D

M

Color

Doppler

ESD caused by discharging of electric charge build-up on insulated surfaces or persons.
RF energy from RF transmitting equipment such as portable phones, hand-held radios, wireless
devices, commercial radio and TV, and so on.
Conducted interference on powerlines or connected cables caused by other equipment, such as
switching power supplies, electrical controls, and natural phenomena such as lightning.

Brief flashes in the
displayed or recorded
image.

For sector imaging
probes, white radial
bands or flashes in the
centerlines of the
image.
For linear imaging
probes, white vertical
bands, sometimes more
pronounced on the
sides of the image.
Increase in the image
background noise or
white M mode lines.

Color flashes, radial or
vertical bands, increase
in background noise, or
changes in color image.
Horizontal lines in the
spectral display or
tones, abnormal noise
in the audio, or both.

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

White dots, dashes,
diagonal lines, or
increase in image
background noise
Color flashes, dots,
dashes, or changes in
the color noise level.

Vertical lines in the
spectral display, popping
type noise in the audio,
or both.

A medical device can either generate or receive electromagnetic interference.
The EMC standards describe tests for both emitted and received interference.

SAMSUNG MEDISON Ultrasound System does not generate 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 source of interference are medical device, 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?

z Does the interference show up only with one transducers operating at the

same frequency or with several transducer?

z Do two different transducer operating at the same frequency have the same

problem?

z Is the interference present if the system is moved to a different location in the

facility?

The answers to these questions will help determine if the problem reside with the
system or the scanning environment. After you answer the question, contact your
local SAMSUNG MEDISON customer service department.

Chapter 2. Safety 2-11

2.4 Mechanical Safety

2.4.1 Moving the Equipment

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z Always turn the power off and disconnect the cables before moving the product.

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NNOOTTEE

z Use the handle on the product, and move the product slowly. You can also move

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the product by using the SonoAce R3 Cart (Optional).

2.4.2 Safety Note

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z Do not press the control panel excessively.

z Never attempt to modify the product in any way.

z Check the operational safety when using the product after a prolonged break in service.

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

z Do not block the ventilation slots.

z To prevent damage to the power cord, be sure to grip the plug head – not the cord –when

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unplugging.

z Excessive bending or twisting of cables on patient-applied parts may cause failure or

intermittent operation of the system.

z Incorrect cleaning or sterilization of a patient-applied part may cause permanent damage.

Please refer to “Chapter 8. Maintenance” for detailed information on protecting,
cleaning and disinfecting the equipment.

Chapter 2. Safety 2-12

2.5 Biological Safety

Verify the alignment of the Probe before use. See the “Chapter 9. Probes”
section of this manual.

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WWAARRNNIINNG

z Ultrasound waves may have damaging effects on cells and, therefore, may be

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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.

z Do not use the system if an error message appears on the video display indicating that a

hazardous condition exists. Note the error code, turn off the power to the system, and call
your local SAMSUNG MEDISON Customer Service Department.

z Do not use a system that exhibits erratic or inconsistent updating. Discontinuities in the

scanning sequence are indicative of a hardware failure that should be corrected before use.

z The system limits the maximum contact temperature to 43 degree Celsius, and the

ultrasonic waves output observes American FDA regulations.

2.5.1 ALARA Principle

Guidance for the use of diagnostic ultrasound is defined by the “as low as
reasonably achievable” (ALARA) principle. The decision as to what is reasonable
has been left to the judgment and insight of qualified personnel. No set of rules
can be formulated that would be sufficiently complete to dictate the correct
response for every circumstance. By keeping ultrasound exposure as low as
possible, while obtaining diagnostic images, users can minimize ultrasonic bio
effects. Since the threshold for diagnostic ultrasound bio effects 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 of the exam.

The ability of the user to abide by the ALARA principle is important. Advances in
diagnostic ultrasound not only in the technology but also in the applications of the
technology, have resulted in the need for more and better information to guide the
user. The output indices are designed to provide that important information

There are a number of variables, which affect the way in which the output display
indices can be used to implement the ALARA principle. These variables include
mass, body size, location of the bone relative to the focal point, attenuation in the
body, and ultrasound exposure time. Exposure time is an especially useful
variable, because the user controls it. The ability to limit the index values over
time support the ALARA principle..

Chapter 2. Safety 2-13

2.5.1.1 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 2D­mode, Power, or Color, disperse or scatter the ultrasonic energy over an area,
while an unscanned mode, like M-mode or Doppler, concentrates 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 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 control.

2.5.1.2 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 first things required during any exam. For example, peripheral vascular
intensity levels are not recommended for fetal exams. Some systems
automatically select the proper range for a particular procedure, while others
require manual selection. Ultimately, the user bears the responsibility for proper
clinical use. The SAMSUNG MEDISON system provides both automatic and
user-definable settings.

Output has direct impact on acoustic intensity. Once the application has been
established, the output control can be used to increase or decrease the intensity
output. The output control allows you to select intensity levels less than the
defined maximum. Prudent use dictates that you select the lowest output intensity
consistent with good image quality.

Chapter 2. Safety 2-14

2.5.1.3 Indirect Controls

The indirect controls are those that have an indirect effect on acoustic intensity.
These controls affect imaging mode, pulse repetition frequency, focus depth,
pulse length, and probe selection.

The choice of imaging mode determines the nature of the ultrasound beam. 2D­mode is a scanning mode, Doppler is a stationary or unscanned mode. A
stationary ultrasound beam concentrates energy on a single location. A moving or
scanned ultrasound beam disperses the energy over a wide area and the beam is
only concentrated on a given area for a fraction of the time necessary in
unscanned mode.

Pulse repetition frequency or rate refers to the number of ultrasound bursts of
energy over a specific period of time. The higher the pulse repetition frequency,
the more pulses of energy in a given period of time. Several controls affect pulse
repetition frequency: focal depth, display depth, sample volume depth, color
sensitivity, number of focal zones, and sector width controls.

Focus of the ultrasound beam affects the image resolution. To maintain or
increase resolution at a different focus requires a variation in output over the focal
zone. This variation of output is a function of system optimization. Different exams
require different focal depths. Setting the focus to the proper depth improves the
resolution of the structure of interest.

Pulse length is the time during which the ultrasonic burst is turned on. The longer
the pulse, the greater the time-average intensity value. The greater the time­average intensity, the greater the likelihood of temperature increase and
cavitations. Pulse length or burst length or pulse duration is the output pulse
duration in pulsed Doppler. Increasing the Doppler sample volume increases the
pulse length.

Probe selection affects intensity indirectly. Tissue attenuation changes with
frequency. The higher the probe operating frequency, the greater the attenuation
of the ultrasonic energy. Higher probe operating frequencies require higher output
intensity to scan at 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.

2.5.1.4 Receiver Controls

Receiver controls are used by the operator to improve image quality. These
controls have no effect on output. Receiver controls only affect how the
ultrasound echo is received. These controls include gain, TGC, dynamic range,
and image processing. The important thing to remember, relative to output, is that
receiver controls should be optimized before increasing output. For example;
before increasing output, optimize gain to improve image quality.

Chapter 2. Safety 2-15

2.5.1.5 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.

2.5.1.6 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) and bone
(TIb). One of these three thermal indices will be displayed at all times. Which one
depends upon the system preset or user choice, depending upon the application
at hand.

The mechanical index is continuously displayed over the range of 0.0 to 1.9, in
increments of 0.1.

The thermal index consists of the three indices, and only one of these is displayed
at any one time.

Each probe application has a default selection that is appropriate for that
combination. The TIb or TIs is continuously displayed over the range of 0.0 to
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.

A default setting is a system control state which is preset by the manufacturer or
the operator.

The system has default index settings for the probe application. The default
settings are invoked automatically by the ultrasound system when power is turned
on, new patient data is entered into the system database, or a change in
application takes place.

The decision as to which of the three thermal indices to display should be based
on the following criteria:

Appropriate index for the application: TIs is used for imaging soft tissue; and TIb
for a focus at or near bone.

Some factors might create artificially high or low thermal index readings e.g.
presence of fluid or bone, or the flow of blood. A highly attenuating tissue path, for
example, will cause the potential for local zone heating to be less than the thermal
index displays.

Scanned modes versus unscanned modes of operation affect the thermal index.
For scanned modes, heating tends to be near the surface; for unscanned modes,
the potential for heating tends to be deeper in the focal zone.

Always limit ultrasound exposure time. Do not rush the exam. Ensure that the
indices are kept to a minimum and that exposure time is limited without
compromising diagnostic sensitivity.

Chapter 2. Safety 2-16

1) Mechanical Index (MI) Display

Mechanical bio effects 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 bio effects 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 bio effects occurring but 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.

2) Thermal Index (TI) Display

The TI informs the user about the potential for temperature increase occuring 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 etc. The TI should be used as a
guide for implementing the ALARA principle.

The bone thermal index (TIb) informs the user about potential heating at or near
the focus after the ultrasound beam has passed through soft tissue or fluid, for
example, at or near second or third trimester fetal bone.

The cranial bone thermal index (TIc) informs the user about the potential heating
of bone at or near the surface, for example, cranial bone.

The soft tissue thermal index (TIs) informs the user about the potential for heating
within soft homogeneous tissue.

You can select either TIs or TIb using the TIs/TIb selection on the Miscellaneous
system setups.

TIc is displayed when you select a trans-cranial application.

3) Mechanical and Thermal indices Display Precision and Accuracy

The Mechanical and Thermal Indices on the system are precise to 0.1 units.

The MI and TI display accuracy estimates for the system are given in the Acoustic
Output Tables manual. These accuracy estimates are based on the 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 investigated tissue
or organs. The initial data that is used to support the output display is derived
from laboratory measurements based on the AIUM measurement standard. The
measurements are then put into algorithms for calculating the displayed output
values.

Many of the assumptions used in the process of measurement and calculation are
conservative in nature. Over-estimation of actual in situ exposure, for the vast
majority of tissue paths, is built into the measurement and calculation process.
For example:

Chapter 2. Safety 2-17

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 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 steady state to be reached.

A number of factors are considered when estimating the accuracy of display
values: hardware variations, algorithm accuracy estimation and measurement
variability. Variability among probes and systems is a significant factor. Probe
variability results from piezoelectric crystal efficiencies, process-related
impedance differences, and sensitive lens focusing parameter variations.

Differences in the system pulse voltage control and efficiencies are also a
contributor to variability.

There are inherent uncertainties in the algorithms used for estimating acoustic
output values over the range of possible system operating conditions and pulse
voltages. Inaccuracies in laboratory measurements are related to differences in
hydrophone calibration and performance, positioning, alignment and digitization
tolerances, 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 not based on errors in, or caused by
measuring according to, the AIUM measurement standards. They are also
independent of the effects of non-linear loss on the measured values.

2.5.1.7 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 onscreen output values.

1) POWER

Power controls the system 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.

Chapter 2. Safety 2-18

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.

2.5.1.8 2D mode Controls

1) 2D mode size

Narrowing the sector angle may increase the frame rate. This action will increase
the TI. Pulse voltage may be automatically adjusted down with software controls
to keep the TI below the system maximums. A decrease in pulse voltage will
decrease MI.

2) ZOOM

Increasing the zoom magnification may increase frame rate. This action 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.

3) Persistence

A lower persistence will decrease the TI. Pulse voltage may be automatically
increased. An increase in pulse voltage will increase MI.

4) 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.

5) 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.

2.5.1.9 Color and Power Controls

1) Color Sensitivity

Increasing the color sensitivity may increase the TI. More time is spent scanning
for color images. Color pulses are the dominant pulse type in this mode.

2) Color Sector Width

Narrower color sector width will increase color frame rate and the TI will increase.
The system may automatically decrease pulse voltage to stay below the system
maximum. A decrease in pulse voltage will decrease the MI. If pulsed Doppler is
also enabled then pulsed Doppler will remain the dominant mode and the TI
change will be small.

Chapter 2. Safety 2-19

3) 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 TI change will be small.

4) SCALE

Using the SCALE control to increase the color velocity range may increase the TI.
The system will automatically adjust pulse voltage to stay below the system
maximums. A decrease in pulse voltage will also decrease MI

5) SEC 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.

2.5.1.10 M mode and Doppler Controls

1) Speed

M-mode and Doppler sweep speed adjustments will not affect the MI. When M­mode sweep speed changes, TI changes

2) 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.

3) 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 MI.

2.5.1.11 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.

Chapter 2. Safety 2-20

1) Probe

Each probe model available has unique specifications for contact area, beam
shape, and center frequency. Defaults are initialized when you select a probe.
SAMSUNG MEDISON factory defaults vary with probe, application, and selected
mode. Defaults have been chosen below the FDA limits for intended use.

2) DEPTH

An increase in 2D-mode depth will automatically decrease the 2D-mode frame
rate. This would decrease the TI. The system may also automatically choose a
deeper 2D-mode focal depth. A change of focal depth may change the MI. The MI
displayed is that of the zone with the largest peak intensity.

3) Application

Acoustic output defaults are set when you select an application. SAMSUNG
MEDISON factory defaults vary with probe, application, and mode. Defaults have
been chosen below the FDA limits for intended use.

2.5.1.12 Related Guidance Documents

For more information about ultrasonic bio effects and related topics refer to the
following;

AIUM Report, January 28, 1993, “Bio effects and Safety of Diagnostic Ultrasound”

Bio effects 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.

2.5.1.13 Acoustic Output and Measurement

Since the first usage of diagnostic ultrasound, the possible human biological
effects (bio effects) of ultrasound exposure have been studied by various
scientific and medical institutions. In October 1987, the American Institute of
Ultrasound in Medicine(AIUM)은 Bio effects Committee (Bio effects

Chapter 2. Safety 2-21

Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept.
1988: Vol.7, No.9 Supplement) sometimes referred to as the Stowe Report, which

reviewed available data on possible effects of ultrasound exposure. Another
report“Bio effects 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 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)

2.5.1.14 In Situ, Derated, and Water Value Intensities

All intensity parameters are measured in water. Since water does not absorb
acoustic energy, these water measurements represent a worst case value.
Biological tissue does absorb acoustic energy. The true value of the intensity at
any point depends on the amount and type of tissue and the frequency of the
ultrasound that passes through the tissue. The intensity value in the tissue, In

Situ, has been estimated using the following formula:

In Situ = Water [

e

]

)23.0( alf

−

where: In Situ = In Situ Intensity Value
Water = Water Value Intensity
e = 2.7183
a = Attenuation Factor
Tissue a(dB/cm-MHz)
Brain .53
Heart .66
Kidney .79
Liver .43
Muscle .55
l = skin line to measurement depth (cm)
f = Center frequency of the transducer/system/mode combination (MHz)

Since the ultrasonic path during an examination is likely to pass through varying
lengths and types of tissue, it is difficult to estimate the true In Situ intensity. An
attenuation factor of 0.3 is used for general reporting purpose; therefore, the In
Situ value which is commonly reported uses the 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 at the
same operating condition; therefore, the reported maximum water and derated
values may not be related to the In Situ (derated) formula. Take for example a
multi-zone array transducer that has maximum water value intensities in its
deepest zone: the same transducer may have its largest derated intensity in one if
its shallowest focal zones.

Chapter 2. Safety 2-22

2.5.1.15 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/cm2.

Pr.3 The derated peak rarefactional pressure (megapascals) associated with

the transmit pattern giving rise to the reported MI value.

WO The ultrasonic power (milliwatts). For the operating condition giving rise

to ISPTA.3, WO is the total time-average power;. For operating
conditions subject to reporting under ISPPA.3, WO is the ultrasonic
power associated with the transmit pattern giving rise to the value
reported under ISPPA.3

Fc The 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 range of center frequencies of the respective transmit
patterns.

ZSP The axial distance at which the reported parameter is measured

(centimeters).

x-6,y-6 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).

Chapter 2. Safety 2-23

2.5.1.16 Acoustic Measurement Precision and Uncertainty

The Acoustic Measurement Precision and Acoustic Measurement Uncertainty are
described below.

Quantity Precision Total U ncertainty

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 %

1) Systematic Uncertainties

For the pulse intensity integral, derated rarefaction pressure Pr.3, center
frequency and pulse duration, the analysis includes considerations of the effects
on accuracy of:

Hydrophone calibration drift or errors.

Hydrophone / Amp frequency response.

Spatial averaging.

Alignment errors.

Voltage measurement accuracy, including.

Oscilloscope vertical accuracy.

Oscilloscope offset accuracy.

Oscilloscope clock accuracy.

Oscilloscope Digitization rates.

Noise.

The systematic uncertainties Acoustic power measurements using a Radiation
Force are measured through the use of calibrated NIST acoustic power sources.

We also refer to a September 1993 analysis done by a working group of the IEC
technical committee 87 and prepared by K. Beissner, as a first supplement to IEC
publication 1161.

The document includes analysis and discussion of the sources of error /
measurement effects due to:

Balance system calibration.

Absorbing (or reflecting) target suspension mechanisms.

Linearity of the balance system.

Extrapolation to the moment of switching the ultrasonic transducer (compensation
for ringing and thermal drift).

Target imperfections.

Absorbing (reflecting ) target geometry and finite target size.

Target misalignment.

Chapter 2. Safety 2-24

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.

Chapter 2. Safety 2-25

2.6 Environmental Protection

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

z The console and peripherals could be sent back to manufacturers for recycling or

˙

N

proper disposal after their useful lives.

z Disposal of waste shall be disposed in accordance with national laws.

z The waste sheaths are to be disposed of safely and national regulations must be

observed.

Waste Electrical and Electronic Equipment

Chapter 2. Safety 2-26

CChhaapptteerr33.. IInnssttaalllliinngg tthhee PPrroodduucctt

3.1 Overview

Chapter 3 contains the information necessary to plan the installation of SonoAce
R3 and install it. This chapter describes the requirements for the transportation
and installation environment for the product, so that the product is installed in the
best condition. Also included are product installation and set up procedures and
electrical security check procedures. In addition, procedures for connecting
probes and external equipment are included.

Contents

3.1 Overview ....................................................................................................3-1

3.2 Transportation ...........................................................................................3-3

3.2.1 Precautions for Transportation ...............................................3-3

3.2.2 Temperature and Humidity ....................................................3-3

3.3 Unpacking ..................................................................................................3-4

3.3.1 Unpacking the Box ..................................................................3-4

3.3.2 Checking Package contents ..................................................3-5

3.4 Precautions for Installation .......................................................................3-6

3.4.1 Precautions ..............................................................................3-6

3.5 Installation Procedure ...............................................................................3-7

3.5.1 Installation Safety ....................................................................3-7

3.5.2 Connecting the Power Cord ...................................................3-8

3.5.3 Connecting the Network Cable ..............................................3-9

3.5.4 Connecting the Probe .............................................................3-9

3.6 Starting the Product ............................................................................... 3-10

3.7 Shutting down the Product .................................................................... 3-11

3.8 Connecting the Peripherals ................................................................... 3-12

3.8.1 External Peripherals ............................................................ 3-12

3.9 System Setting ....................................................................................... 3-14

3.9.1 General System Setup ........................................................ 3-14

3.9.2 Display Setup ....................................................................... 3-16

3.9.3 Misc ....................................................................................... 3-18

3.10 Measure Setting ..................................................................................... 3-19

3.10.1 General ................................................................................. 3-19

3.10.2 Doppler ................................................................................. 3-20

3.10.3 Report ................................................................................... 3-21

3.10.4 OB ......................................................................................... 3-22

Chapter 3. Installing the Product 3-1

3.10.5 Fetal Echo ............................................................................ 3-25

3.10.6 Cardiac.................................................................................. 3-26

3.10.7 Urology.................................................................................. 3-26

3.10.8 Vascular ................................................................................ 3-27

3.11 Setting DICOM ( Optional ) .................................................................... 3-28

3.11.1 Setting DICOM Information ................................................. 3-28

3.11.2 Network Setup ...................................................................... 3-29

3.11.3 Adding or Changing the DICOM Server ............................ 3-29

3.11.4 Editing the DICOM Server Information ............................... 3-32

3.11.5 Deleting DICOM Server ....................................................... 3-32

3.11.6 Testing DICOM Server ........................................................ 3-32

3.11.7 DICOM Log .......................................................................... 3-32

3.12 Setting Option ......................................................................................... 3-34

3.13 Setting Peripheral Devices .................................................................... 3-35

3.13.1 Video Out Type .................................................................... 3-35

3.13.2 Foot Switch ........................................................................... 3-35

3.13.3 Printer 1 ................................................................................ 3-35

3.13.4 Printer 2 ................................................................................ 3-35

3.14 Information .............................................................................................. 3-36

Chapter 3. Installing the Product 3-2

3.2 Transportation

SonoAce R3 is a sensitive piece of electronic medical equipment. Take care
when moving it.

3.2.1 Precautions for Transportation

The box packaging is designed to diminish the effects of any impact to the
product. However, take care not to subject the product to any external impact.

3.2.2 Temperature and Humidity

The following [Table 3-1], “Temperature and Humidity Requirements” shows the
required temperature and humidity for the transportation, care and operation of
the product.

Type

Transportation -25 ~ 60 20 ~ 90

Care -10 ~ 50 20 ~ 90

Operation 10 ~ 35 30 ~ 75

Temperature [OC]

Humidity [%]

[Table 3-1] Temperature and Humidity Requirements

Chapter 3. Installing the Product 3-3

3.3 Unpacking

3.3.1 Unpacking the Box

1) Remove the box strap.

2) Lift the top side of the box up and remove it.

3) Lift the box body up and remove it.

4) Remove the protective plastic packaging.

5) Take the probe and accessory boxes out and put them in a safe place.

[Figure 3-1] Unpacking the Box

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

When moving the product up a steep incline or over a long distance, there is a danger
of injury.

Chapter 3. Installing the Product 3-4

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3.3.2 Checking Package Contents

Unpack the product’s packaging and check the package contents.

If there are any missing parts, contact your dealer.

[Figure 3-2] Contents of SonoAce R3 Package

Chapter 3. Installing the Product 3-5

3.4 Precautions for Installation

3.4.1 Precautions

Please follow the precautions below.

1) Avoid installing the product where water may get into it.

2) Avoid installing the product in direct sunlight.

3) Avoid installing the product in places where there are high temperature

fluctuations.

4) Temperatures of 10OC ~ 35 OC and a humidity of 30% ~ 75% are required

for normal operation..

5) Avoid installing the product near a heater.

6) Avoid installing the product in a dusty location, or where there is a lack of

ventilation.

7) Avoid installing the product in a location subject to vibration.

8) Avoid installing the product where there are chemicals or gas.

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

y If you use the product near a generator, X-Ray equipment, or a broadcasting

transmission cable, the screen may not work normally due to interference.

y In addition, sharing the same wall outlet with other electric equipment may cause

noise.

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Chapter 3. Installing the Product 3-6

3.5 Installation Procedure

3.5.1 Installation Safety

˙˙˙˙˙˙˙˙˙˙˙

DDAANNGGEER

y If you use the product near a generator, X-Ray equipment, or a broadcasting

transmission, cable, the screen may not work normally due to interference.

y In addition, sharing the same wall outlet with other electric equipment may cause

noise.

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

y When moving or storing the product for a long time, you should check the

temperature and humidity of the environment.

y Turn the power on after referring to the information in the following [Table 3-2]

“ProductOperation Temperature”.

y Sudden temperature change causes dew and may generate problems in the

product.

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

Time to Wait 16 10 8 6 4 2 즉시 사용 2 4 6 10

˙

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[Table 3-2] Product Operation Temperature

Chapter 3. Installing the Product 3-7

3.5.2 Connecting the Power Cord

Make sure to check the output voltage of the wall outlet in the installation location.

For the stable operation of EKO7, use it within the voltage range specified in the
following [Table 3-3] “Product Voltage”.

Connect the power cord to the power port on the back panel of SonoAce R3.

˙

˙˙˙˙˙˙˙

E

NNOOTTE

The product and the power cord may be connected before shipping.

Power cable

[Figure 3-3] Product Power

Voltage

Allowable Voltage

Range

Current Frequency

100-120VAC +/- 10% 10A 50~60Hz

200-240VAC +/- 10% 10A 50~60Hz

[Table 3-3] Product Voltage

Chapter 3. Installing the Product 3-8

3.5.3 Connecting the Network Cable

Connect the network cable to the LAN port on the back panel of SonoAce R3.

[Figure 3-4] Network Cable Connection

3.5.4 Connecting the Probe

SonoAce R3 provides 2 probe connections on its back panel.

Place a probe in the probe holder and connect it up.

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

˙

N

Do not connect with excessive force, to prevent damage to the probe

connection pin and the connector PCB.

1) Connect probe when the probe locking lever is unlocked .

2) Connect probe with the probe cable pointing downwards..

˙

˙˙˙˙˙˙˙

E

NNOOTTE

Probe of connection options, depending on the product may be a number.

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

˙

N

Although you can connect a probe when the power is on, do not connect or

disconnect a probe during the booting sequence of the product.

Chapter 3. Installing the Product 3-9

3.6 Starting the Product

1) Check again if the power capacity is compliant with EKO7 and connect the

power cord to the wall outlet..

2) After checking the connection between SonoAce R3 and power cable, turn

on the power switch on the control panel. [Figure 3-10]

Power On/Off

[그림 3-5] Control Panel Power button

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

During booting the system, do not press any key of the alphanumeric keyboard. It
may cause malfunction.

3) To start SonoAce R3, press the On/Off switch at the right side of the control

panel (keyboard).

① The booting sequence is displayed on the LCD monitor. As the SonoAce

R3 logo and loading bar appear.

② The loading bar fills with color. This represents data being copied to the

Front End and Back End of system by the PC software.

③ When software data copying is completed, the ultrasound picture

appears and the system becomes ready. The booting sequence of the
product takes approximately 1 minute.

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Chapter 3. Installing the Product 3-10

3.7 Shutting down the Product

SonoAce R3 to the end of the control panel Power On / Off button is used.

Turning the system off: Press the On/Off switch at the right side of the control
panel(keyboard). Press and hold down the button for 2 seconds to turn the
product On..

Power On/Off

[그림 3-6] Power Switch

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

y Switching off the cut-off switch : You can cut off the power by switching off the

cut-off switch after turning the system off.

y Cut the power off in the event of storing the product for a long period of time, or

when repairing the product.

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Chapter 3. Installing the Product 3-11

3.8 Connecting the Peripherals

SonoAce R3 provides various connectors so that various external devices can be
connected. Peripherals can include a mono printer, color printer, line printer, USB
storage device, and VCR. These are peripheral devices that can be connected for
use when needed and are connected via the USB port located at the rear panel.

˙

˙˙˙˙˙˙˙

E

NNOOTTE

Refer to the operation manual of peripheral device about its operating.

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

When using a peripheral device from a USB port, always turn the power off before
connecting/disconnecting the device. Connection / disconnection of USB devices
during power-on may lead to malfunction of the system and USB devices.

˙

˙˙˙˙˙˙˙

E

NNOOTTE

y When remove the removable disk, use Utility > Storage manager.

y We recommend that you connect USB storage devices (MO drive, flash memory

3.8.1 External Peripherals

3.8.1.1 Video Page Printer

3.8.1.2 USB Video Printer

3.8.1.3 InkJet Printer

3.8.1.4 LaserJet Printer

3.8.1.5 USB MO Disk Drive

3.8.2.6 Flash Memory media

media,etc.) to the ports on the front panel and other USB peripheral devices to
the rear panel for added convenience..

Color : SONY UP-20, SONY UP-21MD

Black and White : SONY UP-897MD, MITSUBISHI P-91, MITSUBISHI P-93W

Color : SONY UP-D23MD

Black and Whiite : SONY UP-D897

HP DeskJet 5650, HP DeskJet 5940, HP DeskJet 6540, HP DeskJet 6970,

HP DeskJet 6980

HP LaserJet 1320, HP LaserJet 2420, HP LaserJet P2015, HP Color LaserJet 3600,

HP OfficeJet J5780, HP OfficeJetPro K550

Fujitsu DynaMO1300U2B

Imation iFLASH USB2.0 1GB, Imation USB Swing Blue 1G

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Chapter 3. Installing the Product 3-12

3.8.2.7 CD-RW

MyBox(External USB Case)+ LG CDRW 52x, LiteON LTR-52327SX CD-RW

LiteON CD-RW/DVD-ROM(SOHC-5232KX), LiteON CD-RW(SOHR-5239SX)

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

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y You must install Linux or above (English) compatible printer and driver Contact

SAMSUNG MEDISON customer service Team for inquiries about printer driver
installation.

y When connecting the printer, ensure that the printer is configured under Linux or

system setup and has been chosen as the default printer .

y Please check the port used in printer before connecting. Printers should be

connected to the Printer port while the USB printer connected to the USB port.

˙

˙˙˙˙˙˙˙

E

NNOOTTE

y If you use the USB 1.1 flash memory, the system cannot recognize it. In the case

of this,delete the flash memory from the console and quip again.

y Regarding file formats that are not ordinarily saved: Please check first to see if it

is possibleto save the file format on a desktop PC before trying to save the file on
a Flash Memory.

Chapter 3. Installing the Product 3-13

3.9 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. Press the “8” key, Setup, on the keyboard

2. The Setup screen will appear. Select a tab that has items to specify.

3. Specify settings for each item.

4. The setting is completed when you press the “8”key.

˙

˙

※

※

3.9.1 General System Setup

3.9.1.1 Institution

˙

˙˙˙˙˙˙˙˙˙

TTiippss!!

-You can select a tab in either of two ways as desired.

- Use the Trackball and the Set button to select a tab.

˙

˙

˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙

–

–

SSeelleeccttiinngg aa ttaab

Select the General tab in the Setting screen. You can specify general settings
such as title settings

Enter the name of the hospital / institution

˙

b

[Figure 3-7] Setup-General

Chapter 3. Installing the Product 3-14

3.9.1.2 Language

This sets the language to be used. English, Deutsch, Français, Italiano, Español,
Russian, and Simplified Chinese are available. To display the screen in the
selected language, reboot the system after completing setup.

The input setup of key button is automatically updated..

˙

˙˙˙˙˙˙˙

E

NNOOTTE

You cannot input following characters; # [ “ ; : ? | ￦

3.9.1.3 Date

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

3.9.1.4 Time

The current time is displayed.

˙

˙˙˙˙˙˙˙

E

NNOOTTE

y You cannot change the date and time when a patient ID is registered. To change

the date and time, you should finish the current diagnosis by pressing End Exam
on the control panel.

y You can select the year from 2006 to 2027.

˙

※

※

˙

˙

˙˙˙˙˙˙˙

˙˙˙˙˙˙˙˙˙˙˙˙˙

TTiipp!!

HHooww ttoo sseett tthhee ddaattee aanndd ttiimme

˙

˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙

˙

e

1. Press [Set] in the Date (or Time) button.

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

3. If it is properly set, press Apply to apply changes. Press OK to close the Date &
Time window. To cancel, press Cancel or the Exit button on the control panel.

[Figure 3-8] Date & Time

Chapter 3. Installing the Product 3-15

3.9.1.5 Boot Up Caps Lock Status

This menu sets the initial status of Caps Lock after system boot-up. Its default
value is ‘Off’. This Caps Lock enables capital letter entry without the need to
press the Shift key.

3.9.1.6 Autotext Set

Select Autotext Set to use the Autotext text function. Its default value is ‘Off’.

Using the Autotext text function allows fast and easy input of text statements. For
example, to enter the text ‘Tumor’, you only need to enter ‘Tu’ and the system will
search the word from the abbreviation list and automatically enter the word
‘Tumor’.

˙

※

※

˙

˙

˙˙˙˙˙˙˙

˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙˙

TTiipp!!

AAuuttootteexxtt SSeett EEddiit

˙

˙

˙

t

Click Edit on the screen. The Autotext Table Edit Table window will be appeared. To
add a new abbreviation, click New, and to completely delete an existing abbreviation,
click the entry to be deleted and then click Delete.

‘Delay(msec)’ sets seconds to input the full word after enter the abbreviation. The unit
value is msec, and 1000msec is 1second.

[Figure 3-9] Autotext Set Edit

3.9.2 Display Setup

To set the information about images and related data, select the Display tab in the
System menu.

3.9.2.1 Auto Freeze

After the preset time span (Minute) of inactivity, the scan mode is automatically frozen

Chapter 3. Installing the Product 3-16

3.9.2.2 Post Map

This sets the display of the Post Map in the Feedback section at the bottom of the screen.

3.9.2.3 TGC Line

This sets whether or not the TGC line is displayed. If ‘Off’ is selected, the TGC
Line is not shown. If ‘Off after 3 seconds’ is selected, the TGC value appears
when a TGC value is adjusted, but disappears after 3 seconds. If ‘On’ is selected,
the TGC Line is always shown.

3.9.2.4 TI (Thermal Index) Display

The system sets TI values automatically. However, this menu allows the user to
choose manually from one of the three TI parameters as desired: Default, TIs or TIb

3.9.2.5 HPRF

Enable or disable High Pulse Repetition Frequency (HPRF) supported in the PW
Spectral Doppler mode. If it is set to ‘On,’ HPRF is supported by default

3.9.2.6 Bodymarker After Freeze

Determine whether the system will automatically switch to the Body Marker mode
when the Freeze button is pressed. If it is set to ‘On,’ a Body Marker appears
when the Freeze button is pressed during scanning. If it is set to ‘Off,’ a Body
Marker appear only when BodyMarker is pressed during scanning

3.9.2.7 2D Image Size

The Image size can be set to 100%, 95% or 90%.

3.9.2.8 Simultaneous Mode

This menu determines whether or not simultaneous mode is enabled in PW
Spectral Doppler Mode.

‘Off’: Select this if you do not wish use simultaneous mode.

-

-

‘Allow 2D / PW: Select this if you wish to use simultaneous mode in 2D / PW mode.

-

‘Allow 2D / C / PW: Select this if you wish to use simultaneous mode in 2D / C / PW mode.

[Figure 3-10] System-Display

Chapter 3. Installing the Product 3-17

3.9.3 Misc

Select the Misc. tab in the System menu.

3.9.3.1 OB Measure Shortcut Key

Assign commonly used obstetrics measurement items to number keys in the

alphanumeric keyboard. You can use this feature to start a desired obstetrics

measurement instantly while scanning.

3.9.3.2 Shortcut Key Setup

Metrics in the obstetrics of the numeric keyboard set. BPD, FL, APTD, TTD, AC /
FTA, GS, CRL can choose.

3.9.3.3 Hibernation

To booting speed up, set this item as ‘On’.

[Figure 3-11] Misc.

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The system turns off with normal shutdown after 30th booting with ‘Hibernation On’.
However the system will start with ‘Hibernation On’ on the next booting.

3.9.3.4 Thumbnail

To use thumbnail list, set this item as ‘On’. Thumbnails of saved images are
showed up on the right side of the screen.

3.9.3.5 Set/Exit Key Setup

Set the position of the Set and Exit buttons.

3.9.3.3 TrackBall Speed

Set the trackball speed during scan mode to Slow, Normal or Fast

Chapter 3. Installing the Product 3-18

3.10 Setting Measurements

Select Measure in the Setup menu to set up measurement functions.

1. Press the Setup key on the keyboard. Setup screen is appeared.

2. Select Measure in the Setup menu.

3. Set the specific system values according to each item on the screen.

4. Click Ok to finish the setup. To close the screen, click Cancel or X.

3.10.1 General

Select the General tab in the Measure menu to set general measurement settings.

[Figure 3-12] Measure-General

3.10.1.1 Measure Item Display Count

Select the number of measurement items to be between 1 and 3. If you select
‘Hide’, measurement items are not displayed.

3.10.1.2 Circ/Area Method

Select either the ‘Ellipse’ or ‘Trace’ caliper to be the default tool for measurement.

3.10.1.3 Default Volume Method

Select either the ‘3 Distance’, ‘1 Distance’ or ‘Distance + Ellipse’ items to be used
as the default tool in volume measurement.

3.10.1.4 Distance method

Set either ‘Line’ or ‘Trace’ as the distance measurement method.

Chapter 3. Installing the Product 3-19

3.10.1.5 Caliper Display Unit

Set either ‘cm’ (centimeter) or ‘mm’ (millimeter) as the caliper display unit.

3.10.1.6 Track Ball Speed

Set the trackball speed to either ‘Fast’, ‘Medium’ or ‘Slow’

3.10.1.7 Result Display

Set the output format of measurement results in the report. When ‘Average Value’
is selected, the report shows the average value of the last three measurement
results. When ‘Last Measured Value’ is selected, the last measurement value is
shown

3.10.2 Doppler

Select the Doppler tab in the General tab.

3.10.2.1 Y-Axis Unit

This sets the vertical (Y) axis unit in Spectral Doppler Mode.

3.10.2.2 Trace Direction

When Auto Trace and Limited Trace functions are used in Spectral Doppler Mode,
this sets the range of the measurement values

3.10.2.3 Control Thershold

The trace threshold can be adjusted by rotating the Menu dial-button when tracing
is not finished after Auto trace / Limited trace.

3.10.2.4 Mean Trace

This menu specifies the use of Mean Trace Line on the screen for Auto trace /
Limited trace.

[Figure 3-13] Measure-Doppler

Chapter 3. Installing the Product 3-20

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Press the space bar after pressing the Calc button to bring up the Setting Measure
Method window shown below.

3.10.3 Report

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HHooww ttoo cchhaannggee DDoopppplleerr sseettttiinngg dduurriinngg mmeeaassuurreemmeennt

[Figure 3-14] Setting Measure Method

Select the Report tab in the General tab. Select items to mark the header on the
report. The header will be shown only the item has its data.

[Figure 3-15] Measure-Report

t

Chapter 3. Installing the Product 3-21

3.10.4 OB

Select the OB tab in the Measure menu.

3.10.4.1 Display SD Value

This menu sets whether SD (Standard Deviation) is displayed or not. If ‘Yes’ is
selected, the SD value is shown on the screen and on the report. If ‘No’ is
selected, it is not shown and its range value appears on the report.

3.10.4.2 HC Auto Calc

Set whether to automatically calculate the HC. 'Yes' if you were selected to
measure its own or as a result of OFD and BPD to calculate the value of HC
appears on the screen. 'No' if the OFD and BPD were selected to measure the
value of HC can not appear on the screen.

3.10.4.3 Fetal Weight

This menu is used to set the measurement items used for fetal examination. In the
fetal weight and fetal weight growth fields, more measurement items can be added.

▶ Unit : This sets the unit of fetal weight measurement. You can choose from
grams [g], ounces [oz], and pounds [lb].

▶ Auxiliary Unit : This sets the auxiliary unit of fetal weight measurement. Unit
sets the available auxiliary unit. For instance, set the unit as Gram [g], available
units are None, oz, lb, or lb+oz. If you select lb+oz as an auxiliary unit, the value
will be shown like as xx lb yy oz.

▶ Display SD: This menu sets the SD information shown in the result display
section: No, SD or Percentile. Both SD and Percentile appear in the report.

[Figure 3-15] Measure-OB

Chapter 3. Installing the Product 3-22

3.10.4.4 Preset

Measurement items used during exams are set. Set a specific preset in the Name field

User Preset

If the [+]beside the Name field is selected, a user can set a new preset.

Enter a title in the Preset Name field and an explanation in the Description field.
Press Ok.

After a new preset is made, register items in the right-hand list to use in obstetrics

measurement. When [<<] is clicked, the items in the right list are moved to the left
list to be used with the user preset. To delete the items from the left list, select
them and click [>>].

To delete a user preset, select it and click [-]. Because `General and Fetal
Biometry’ are system presets, cannot be deleted..

Table and Equation

The measurement items used in the Preset menu are GA and Fetal Growth. The

measurement values of GA and Fetal Growth are shown in table or equation form.

When is clicked, the contents of the GA or Fetal Growth’s table and equation
contents are shown. When is clicked, a user can set a specific value, and when is
clicked, the table and equation set by the user are erased. However, the default
values provided by the system are not erased.

For more information about each table and equation, refer to the Reference Manual

3.10.4.5 Graph

The user can select graphs to mark on the OB report or print. Press Graph button
and select items. After selecting / deselecting a specific item, click Close.

MCA / UA Graph

MCA / UA is associated with four different graphs (MCA PI, MCA RI, UA PI, UA
RI) to be included in the OB Report Graph whether to select it.

[Figure 3-16] New Preset

Chapter 3. Installing the Product 3-23

HC / AC Graph

Ratio of HC and AC are displayed in the graph.

Report Graph

Select the reports to display graphs. 'All' is selected, all graphs are displayed,
'Data Exist', select a graph that displays the data.

Print Graph

Select to print the graph. 'All Graph in Report' indicated in the report to print all the
graphs and the 'Data Exist' If you choose to print the data in the graph. 'Current
Page' to print the current page

3.10.4.6 Backup / Restore

Backup

If you want to back up a n ew user preset to Mo Media, Flash Memory or a HDD,
press Backup/Restore on the screen. When the setting window is displayed,
select the disk and directory. Directories can be created or deleted using the New
Dir. or Remove Dir. Take care when deleting directories or files. Once a file or
directory is erased, it cannot be restored. During user-preset backup, all user
reference tables / equations are backed up. Separate tables/equations backup is
therefore not necessary.

Restore

To bring up the backed up user preset, click Backup/Restore. When the Backup /
Restore screen appears, select the disk and directory which the user preset is to
be restored to.

[Figure 3-17] Graph

Chapter 3. Installing the Product 3-24

3.10.5 Fetal Echo

Select the Fetal Echo tab in the Measure menu.

During obstetric measurement, Fetal volume can be measured in M Mode. The
calculation method is set in the ‘LV Volume Calculation’. The options are the
same as those in the cardiac package (Teichholz, Cubed, or Gibson).

[Figure 3-18] Backup/Restore

[Figure 3-19] Measure-Fetal Echo

Chapter 3. Installing the Product 3-25

3.10.6 Cardiac

Select the Cardiac tab in the Measure menu.

3.10.6.1 2D Circumference and Area Method

Select either the ‘Ellipse’ or ‘Trace’ caliper to be the default tool for area
measurement.

3.10.6.2 LV Volume Calculation

The LV Volume Calculation method is set with this menu.

[Figure 3-20] Measure-Cardiac

3.10.7 Urology

Select the Urology tab in the Measure menu.

3.10.7.1 Volume Method

▶3 Distance : The volume value is calculated using three diameters in the
longitudinal and transverse planes. (4 / 3 x 3.14 x A x B x C / 8)

▶3 Distance x Factor: The volume value is calculated using three diameters from
the longitudinal plane and transversal plane and a factor (F) value entered by a
user. ( A x B x C x F)

▶Ellipsoid: The volume value is calculated using the lengths of the Main axis and
the beside axis. (4 / 3 x 3.14 x Main / 2 x (Beside / 2)Λ2)

▶Sum of 20 Disks: The volume value is calculated by summing the areas in the
20-parallel planes. (d / 20 x (A1 + A2 + ... A20), d : the sum of distances between
disks)

Chapter 3. Installing the Product 3-26

3.10.7.2 Predicted PSA Correction Factor

The Predicted PSA Correction Factor can be changed. The default value is 0.12.

[Figure 3-21] Measure-Urology

3.10.8 Vascular

Select the Vascular tab in the Measure menu. You can set the peak velocity used
in the calculation of the ‘A/B Ratio’ and ‘ICA/CCA Ratio’.

[Figure 3-22] Measure-Vascular

Chapter 3. Installing the Product 3-27

3.11 Setting DDICOM ( Optional)

Select the DICOM tab in the Setup menu. This function is used to set up the
DICOM server and other DICOM-related functions.

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For more information, refer to the user manual of the corresponding server and
the DICOM Conformance Statement.

3.11.1 Setting DICOM Information

3.11.1.1 AE Title

3.11.1.2 Station Name

3.11.1.3 Port No.

3.11.1.4 Network Status

[Figure 3-23] DICOM

Enter the DICOM information for the product in use. For automatic DICOM
transmission, select ‘Acquisition in Progress’ after completing the fields. For
automatic print out, select ‘Print After Each image’.

Enter the DICOM Application Entity title of the ultrasound system. This title uses
to distinguish the ultrasound system in the network. (Ex. US1, US2)

Enter a name to differentiate pieces of ultrasound system. (Ex. SonoAce1,
SonoAce2)

Enter the Port Number of the server being used.

Display the current status of the network.

Chapter 3. Installing the Product 3-28

3.11.2 Network Setup

To set the network like IP address, press System Network Settings. To set the IP
value automatically, press ‘Using Dynamic IP Configuration’. If you enter the
wrong IP address, the network will not run. To finish the network setup, click
Apply. To cancel setup, click Close.

3.11.3 Adding or Changing the DICOM Server

Click Add to enter the information related to the DICOM Server.

Store Server Information

Select STORE under Services. Configure the Image Storage Service using
DICOM.

3.11.3.1 Service

Select the kind of server to use. The supported DICOM servers are Store, Print,
and Worklist.

3.11.3.2 Alias

Enter the name of the server being used.

3.11.3.3 Transfer Mode

Select any one of the three image transfer methods.

▶Batch: send all images when you click the End Exam.
▶Send As You Go: send the image whenever you press the Save button.
▶Manual: send the image manually only in the SonoView.

3.11.3.4 Connect Timeout

Set how many seconds the system will wait until get response.

3.11.3.5 IP Address

Enter the IP address of the server being used.

3.11.3.6 Port

Enter the Port Number of the server being used.

3.11.3.7 Retry Interval

Set how many seconds the system will wait if the transmission fails.

3.11.3.8 Maximum Retries

Set how many times the system will retry.

Chapter 3. Installing the Product 3-29

[Figure 3-24] DICOM Configuration- Store

Print Server Information

Select PRINT under Services. Configure the Print Service using DICOM.

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You can configure a printer connected to the DICOM network only.

Depending on the printer, some of the following functions may not be available.
Before configuring a printer service, please refer to the user manual for the printer
or the DICOM Conformance Statement.

3.11.3.9 Color

3.11.3.10Format

3.11.3.11Orientation

3.11.3.12Magnification

3.11.3.13Border Density

3.11.3.14Empty Density

3.11.3.15Min Density

3.11.3.16Max Density

Specify whether to use colors. Select Grayscale or RGB.

Specify the paper layout. Select from 1ⅹ1, 1ⅹ2, 2ⅹ2, 2ⅹ3, 3ⅹ3, 3ⅹ4, 3ⅹ5,
4ⅹ4, 4ⅹ5 and 4ⅹ6..

Specify the paper orientation. Select Landscape or Portrait.

When resizing an image to print, specify the interpolation. Select from Replicate,
Bilinear, Cubic and None.

Specify the border density of an image to print. Select Black or White.

Specify the background color of an image to print. Select Black or White

Specify the minimum brightness of an image to print. If this option is not specified,
the default value is applied.

Specify the maximum brightness of an image to print. If this option is not specified,
the default value is applied.

Chapter 3. Installing the Product 3-30

3.11.3.17Medium Type

Specify the paper type. Select from Paper, Clear Film, and Blue Film.

3.11.3.18Film Size

Specify the paper size. Select from 8inchⅹ10 inch, 10 inchⅹ12 inch, 10 inchⅹ14
inch, 11inchⅹ14 inch, 14 inchⅹ14 inch, 14 inchⅹ17 inch, 24cmⅹ24cm, 24cmⅹ
30cm, and A4

3.11.3.19Destination

Specify the paper pathway. Select Magazine or Processor.

3.11.3.20Priority

Specify a priority for the print command. Select from High, Med and Low.

3.11.3.21Copies

Enter the number of copies between 1 and 99.

3.11.3.22Configuration Info

Specify the unique value for a printer. Please refer to the DICOM Conformance
Statement for the printer.

[Figure 3-25] DICOM Configuration- Print

Worklist Server Settings

Select WORKLIST under Services. Configure the Modality Worklist Service using
DICOM.

3.11.3.23Open MWL on Patient key

Sets the screen that appears when pressing the Patient button on the control
panel. If this function is selected, pressing the Patient button opens the Modality
Worklist window. If not selected, pressing the Patient button opens the Patient
Information screen.

3.11.3.24Update Method

Sets the method for updating Worklist.

▶Only on user Request: Update only when asked by the user.

Chapter 3. Installing the Product 3-31

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.

To update a worklist, in the Search tab on the Patient Information screen, select

Worklist for Search Source and press Search.

▶On Startup and Every: Worklist is updated at the system boot-up and then
updated continually at a set interval. Note that Worklist is not updated while the
Modality Worklist window is open.

3.11.3.25Scheduled Station AE Title

Sets the range of AE Title to fetch from the hospital’s Worklist server.

▶All: Obtains the list of patients saved under all AE Titles within the server.
▶This System: Obtains the list of patients for the AE Titles set under the DICOM tab.
▶Another: Obtains the list of patients for the AE Title directly entered by the user.

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This function is available only if when the Worklist server is configured.

3.11.3.26Start Date

Set the range of dates to search.

▶Today: Obtains the list of patients for the current date.
▶Prior_days, Next_days: Obtains the list of patients for dates between n days

prior to the current date and n days after the current date.

▶Period

From Date: Enter a date and the system obtains the list of patients starting from
the date entered up until the current date.

To Date: Enter a date and the system obtains the list of patients starting from the
current date up until the date entered.

From Date To Date: Enter two separate dates and the system obtains the list of
patients between the two dates entered..

3.11.4 Editing the DICOM Server Information

Click Edit in the setting DICOM window to edit the server information already
entered.

3.11.5 Deleting DICOM Server

Click Delete in the setting DICOM window to erase the current server information.

Chapter 3. Installing the Product 3-32

3.11.6 Testing DICOM Server

Select a service and click Test on the screen. The connection with the selected
service is tested and the results are shown under the Ping and Verify items. If the
result is Normal, it indicates that the connection is normal.

3.11.7 DICOM Log

Click Log in the setting DICOM window, and the screen will be changed. Set or
copy the current DICOM log file.

DICOM log file is the history of all DICOM services performed so far on the
product. Click Close to finish the DICOM log.

3.11.7.1 Log Settings

Set the DICOM Log..
▶Delete archived log file after: set the number of days to wait before deleting the

archived history. After that period, the log file will be deleted. However there is
only one log file, it will not be deleted.

▶Log File Maximum Size: set the maximum size of each history file archived. Set
the unit as Kbytes

3.11.7.2 Explanation

View the log setting.

3.11.7.3 DICOM Log

View, copy, or delete the DICOM log files.
▶View Selected File: Select the log file from ‘Select log files to copy’ and click

View selected file.
▶Copy Selected Files:

1. Select the log files and set the storage file format on the ‘Copy to’.

2. Set the ‘Delete files after copy’ whether to delete the log files saved in the
hard disk of the system.

3. Click Copy selected files.

▶Delete Selected Files: Select the log file and click Delete Selected Files.

Chapter 3. Installing the Product 3-33

3.12 Setting Option

The S/W serial No information of the system is shown in this window. You can
select / cancel S/W options. A user cannot modify options. Click Option tab in the
Setup menu. If the password you enter is not correct, the options are not
activated. If the password is not correct, click Cancel..

[Figure 3-25] Setup-Option

Chapter 3. Installing the Product 3-34

3.13 Setting Peripheral Devices

The following describes how to set up the video output type, video input type,
printer, foot switch and network. Select the Peripherals tab in the Setup menu.

[Figure 3-26] Setup-Peripherals

3.13.1 Video Out Type

Set the video output type as NTSC or PAL.

3.13.2 Foot Switch

Assign functions to the left and right pedals of the foot switch. Four options are
available: Dual, Store, Freeze and Update.

3.13.3 Printer 1

Select a printer to use. After connecting a USB printer to the USB port of the
system, select the printer type on the screen and click Ok. The printer can then be
used immediately.

The USB printer can only be used to print out Report and SonoView screens.

▶ HP Color LaserJet 3600 ▶ HP DeskJet 6540 ▶ HP DeskJet 5650
▶ HP DeskJet 5940 ▶ HP DeskJet 6940 ▶ HP OfficeJet J5780
▶ HP LaserJet 1320 ▶ HP LaserJet 6980 ▶ HP OfficeJet ProK550
▶ HP LaserJet2420 ▶ HP LaserJetP2015

3.13.4 Printer 2

Select a printer to use when you press the Print button. Following printers are
available;.

▶ Analog Printer ▶ Sony UP-D897 ▶ Sony UP-D23MD

Chapter 3. Installing the Product 3-35

3.14 Information

The information menu displays information about the system S/W version. Select
the Information tab in the Setup menu. Press the Detail Info. to view more
detailed information.

[Figure 3-27] Setup-Information

* The S/W version of your system may be different from that in the figure above.

Chapter 3. Installing the Product 3-36

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4.1 Overview

Chapter 4 describes how to check SonoAce R3 and how to check if its major

functions and the power supply are working properly.

Contents

4.1 Overview ....................................................................................... 4-1

4.2 Starting the Product ...................................................................... 4-2

4.3 Monitor .......................................................................................... 4-3

4.3.1 Monitor Display ............................................................. 4-3

4.4 Control Panel ................................................................................ 4-5

4.4.1 Detail Control Panel ..................................................... 4-6

4.4.2 Soft Menu ..................................................................... 4-8

4.4.3 Keyboards .................................................................... 4-9

4.5 Checking the Performance ....................................................... 4-11

4.5.1 Basic Check ................................................................ 4-11

4.5.2 Detail Check ............................................................... 4-12

Chapter 4. Checking the Product 4-1

4.2 Starting the Product

1) Check again if the power capacity is compliant with SonoAce R3 and connect

the power cord to the wall outlet.

2) Check if the SonoAce R3 power cord is properly connected and switch on the

power button for the control panel. [Figure 4-1]

Power Button

[Figure 4-1] Power Button

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CCAAUUTTIIOON

y During booting the system, do not press any key of the alphanumeric keyboard It

may cause malfunction.

y Off again after a power button for about 5 seconds to boot time interval is required.

The booting sequence is displayed on the LCD monitor. The SonoAce R3 logo

and loading bar appear..

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Chapter 4. Checking the Product 4-2

4.3 Monitor

The monitor of this system is a color VGA monitor, which displays ultrasound

images and additional information. This monitor is connected to the main body

through a central pivot, allowing it to be tilted to the optimal viewing angle.

4.3.1 Monitor Display

The monitor displays ultrasound images, operation menus and a variety of other

information. The screen is divided into six sections: ①Title, ②Menu, ③Image,

④Thumbnail, ⑤User Information, and ⑥ Softmenu sections

①

②

③

④

⑤

⑥

[Figure 4-2] Monitor Display

① Title Area

This section displays the Logo, Patient Name, Hospital Name, Application, Frame

Rate & Depth, Probe Information, Acoustic Output Information and Date & Time.

② Menu Area

The menu is divided into 3 kinds : Image adjustment menu, Measurement menu

and Utility menu. Use Menu dial-button to select an item from the menu

③ Image Area

The ultrasound image, image information, annotation, and measurement

information are displayed in the image area..

④ Thumbnail Area

Saved images, by pressing the Save button on the control panel, are displayed in

the thumbnails area. Thumbnails are showed when you check ‘on’ in Setup >

System > Misc. This area shows up to four images.

Chapter 4. Checking the Product 4-3

⑤ User Information Area

A variety of information necessary for system use e.g. current system status and

Body Markers.

⑥ Softmenu

Available menu items may vary depending on the current system state. To set or

change a Soft Menu item, use the corresponding dial-button on the control panel.

Chapter 4. Checking the Product 4-4

4.4 Control panel

The control panel can be used for controlling the system.

① Button
② Dial-Button
③ Slide
④ Track Ball

4.4.1 Detail Control Panel
The following are descriptions and instructions for the controls on the control

panel. For more information on the buttons with multiple functions, see 'Chapter 3'
and later of this manual.

①

④

[Figure 4-3] Control Pane

③

②

On/Off Turns the system on/off.

Displays the Patient Information screen for patient selection
and information entry.

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

End Exam

Patient

Chapter 4. Checking the Product 4-5

Sonoview Runs SONOVIEW TM which is the image filing program.

Report

2D/ Single

M Mode Use this button to enable/disable M Mod e.

C Mode Use this button to enable/disable Color Doppler Mode.

PD Mode Use this button to enable/disable Power Doppler Mode

D Mode

Dual Mode Use this button to enable Dual Mode.

Displays the Report screen that shows the measurement
results of the current application and other information.

[Allows you to select the 2D or Single function

- 2D: Use this button to enable 2D Mode. Pressing
this button in 2D mode does not disab le the
mode. Pressing it in Combined Mod e switches
to 2D Mode.

- Single: In Dual Mode, press this button to switch to
2D Mode.

Use this button to enable/disable PW Spectral Doppler
Mode.

Focus

Depth

Calc

Caliper

Trackball

Change Use this button to change the function of the trackball.

Set

Chapter 4. Checking the Product 4-6

Use this switch to adjust the focus position. The focus
position changes on the ruler as you adjust its position

Use this switch to adjust the scanning depth for the
selected image. The depth information changes in the Title
area as you adjust the depth.

Starts measurements by application. The measurement
menu is displayed on the left side of the screen.

Starts to measure distance, circumference, area, and
volume. The current measurement item is displayed on the
left side of the screen.

Use the trackball to move the cursor on the screen. It can
also be used to search through Cine or Loop images when
Freeze is enabled.

Use this option to select an item or value. In Spectral
Doppler Mode and 3Dmode, it is also used as update
function.

Exit

Menu/

Angle

Clear

Active Mode Changes the menu or soft menu on the screen.

Save

Print

Freeze

Exits the currently used function and returns to the previous
staus.

Carries out the Menu or Angle function.
Menu: Press dial button to activate the available menu item
of current scan mode.
Angle: Rotate the dial-button to adjust the angle. Adjust the
angle of sample
volume in PW Spectral Doppler Mode. It is also used to
adjust the Indicator angle or the Probe angle of Body
Marker.

Deletes text, Indicator, body marker, and measurement
result, etc. displayed on an image

Use this button to save the selected image or report in a
database

Use this button to print the image on the screen via a
printer.

Use this button to freeze the image that is being scanned.
Press it again to return to scan mode.

Carries out the Q Scan or Gain function.

Q Scan/

Gain

TGC

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- Q Scan: Press this dial-button to enable Quick Scan. If
Quick Scan is enabled, ‘Q’
mark is shown in the right hand side of the screen.

- Gain: Rotate this dial-button to adjust Gain in each mode.

Adjusts TGC values for each depth using 6 slides. TGC
stands for Time Gain
Control.

Too large a difference in the gain value settings of adjacent TGC slides may lead
to the generation of stripes in an image.

Chapter 4. Checking the Product 4-7

4.4.2 Soft menu(1~5)

Use the Soft Menu that appears on the screen. Available menu items may vary

depending on the current system state.

4.4.3 Keyboards

This product comes with an alphanumeric keyboard, whic h can be used to enter

text and run a variety of functions by using function keys

[Figure 4-4] Soft menu button

[Figure 4-5] Keyboards

Text

M Cursor

Biopsy

Data on/off

Chapter 4. Checking the Product 4-8

This is used to start Text mode.

This is used to display M line or hide.

This is used to start the biopsy.
This button is used to display information of image on the

upper right side of screen or hide.

3D

Zoom

Setup

Utility

Application

Probe

Storage

Manager

Indicator

Body Marker

Frequency

Harmonic

Imaging

This is used to start or finish the 3D Mode.
This is used to start or finish the Zoom Mode. The Zoom

Navigation Box is displayed on the user information area.
This button is used to appear the Setup screen for setting

system parameters.

This button is used to appear the utility menu.
This is used to appear Application screen to select/change

probes and applications.
This is used to change another probe.

This button is available when you use the two probe
connector (optional).

This button is used to appear the Storage Manager window.

This is used to start or finish the indicator Mode.

This is used to start or finish the Body Marker Mode.
Press the button to change frequency for the probe.

Select Res, Pen or Gen. The selected frequency will be
displayed in the title area.

This is used to turn Harmonic Imaging on. Press this button
again to turn the mode off. This button is only activated with
the specific probe.

Brightness

Sound

Allows you to adjust the monitor brightness.

Allows you to adjust volume in Spectral Doppler Mode.

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If you set the language in Russian, you cannot use function keys under Caps

Lock is on.

Chapter 4. Checking the Product 4-9

4.5 Checking the Performance

4.5.1 Basic Check

1) Monitor

Check the screen color, focus, dots, residual image, spot, blurring, etc..

Check the screen status when a shock is applied to the monitor and check

the signal when you shake the cable.

2) Control Panel and LED Status
Press on control panel key and check if the corresponding character is

displayed on the screen.

Check if the Key board LED is turned on.

3) Body Mark Key

Check if the Body Mark [Body Mark Key] is properly displayed and if the key
works properly.

4) Indicator Key

Check if the trackball works properly by moving it up, down, left and right.

5) Clear Key

Check if TEXT and measurement data is erased properly when this key is
pressed.

6) Zoom Operation Examination

Check that the Zoom works properly.

7) Sonoview Examination

Save an IMAGE and CINE INAGE in each mode.
Check if the images are properly saved.
Check if Backup & Restore works properly.

8) Measure

Check if DISTANCE, CALIPER and CALC works properly.

9) Patient

Enter information in PATIENT and check if the entered contents appear in the
report or SonoView.

10) End Exam

Measure for a New Patient and check if the measured data is cleared when
End Exam is selected.

11) Probe Key

Check if it works properly when the probe is changed.

Chapter 4. Checking the Product 4-10

4.5.1 Detail Check

1) B Mode

① Check if there is any missing line in an image by doing a Knife Test.
② Check if the image is displayed properly through Phantom.
③ Check if Freeze Cine ( Broken Image, Auto run, Auto run Speed and Track

ball Cine) and its related functions work properly.

④ Check if there is an image brightness change when the Gain is adjusted.
⑤ Check if there is an image brightness change when the TGC Gain is adjusted.

⑥ Check if the image is flipped horizontally or vertically and left or right when

the Left/Right Flip, Up/Down Direction and Rotation keys are p re ssed.

⑦ Check if the image select menus (EE, DR, View Area, Tissue, Frame Rate)

work properly.

⑧ Check if the frequency (Phantom, Re s, Pen, Gen) is normal.
⑨ Check if the image changes according to Depth change.
⑩ Check if the image changes according to Depth change when the focus is

changed.

⑪ Check if the image compensation modes (FSI, Harmonic, DMR, SRF, Quick

Scan, Spatial Compound Imaging) work properly.

2) Dual Mode

① Check if the image is displayed properly through Phantom.
② Check if the image is flipped horizontally or vertically and left or right when

the Left/Right Flip, Up/Down Direction and Rotation keys are p re ssed.

③ Check if the image select menus (EE, DR, View Area, Tissue, Frame Rate,

Sane angle, Power) work properly.

④ Check if the frequency (Phantom, Re s, Pen, Gen) is normal.
⑤ Check if the image changes according to Depth change.

⑥ Check if the image changes according to Depth change when the focus is

changed.

⑦ Check if the left or right image Cine (number of pages, Auto run, Auto run

Speed and Track ball Cine) and its related functions work properly.

3) M Mode

① Check if the image is displayed properly through Phantom.
② Check if theinformation on M Line is displayed in the Image area.
③ Check if there is an image brightness change when the GAIN is adjusted..
④ Check if image select menus (EE, DR, View Area, Tissue, Frame Rate, Sane

angle, Power ) work properly.

Chapter 4. Checking the Product 4-11

⑤ Check if image changes ac cording to Depth change.
⑥ Check if the image changes according to Depth change when the focus is

changed

⑦ Check if the speed change and information is correct according to the

SPEED conversion step.

⑧ Check if an image is reversed when Negative operates.
⑨ Check if the Top Down Format and Side by Sede Format Image are correct

when Loop Format is selected.

⑩ Check if the Freeze Cine (Broken Image, Auto run, Auto run Speed and Track

ball Cine) and its related functions work properly.

.

4) C Mode & PD Mode

① Check if the image is displayed properly through Phantom.
② Check if the image select menus (Balance, Sensitivity, Color Mode, Display)

work properly.

③ Check if the image changes according to Depth change.
④ Check if Freeze Cine ( Broken Image, Auto run, Auto run Speed and Track

ball Cine) and its related functions work properly.

⑤ Check if there is image brightness change when the Color Gain is adjusted.
⑥ Check if an image is broken or if there is noise (B or C Mode Noise) When

ROI Box is moved.

⑦ Adjust the Scale up and down and check if the frequency is converted and

blood flow speed range is controlled. (Check with directly scan)

⑧ Operate the filter and check if small signals are rem oved by step.
⑨ Check if the Color Bar is reserved when the Invert key is pressed.
⑩ Move the Baseline up and down and check if the blood flow range moves to

+ or - part.

5) D Mode

① Check if the image is displayed properly through Phantom.
② Check if the Doppler PRF value changes as the Simultaneous is turned on or off.
③ Check if the Doppler spe c trum works properly.
④ Change the Scale and check the speed range change.
⑤ Move the Baseline up and down and check if the blood flow range moves to

+ or – part.

⑥ Operate the filter and check if small signals in the spectrum are removed.
⑦ Operate the Invert and check if the Doppler waveform is reversed.
⑧ Operate the Angle.

Chapter 4. Checking the Product 4-12

⑨ Move the SV or Size and check if it works properly.
⑩ Change the Spectrum Type and check if the spectrum video changes.
⑪ Check if Sound Volume works properly.
⑫ Check if the line when appears when Auto Calc runs is continuous and if the

subsequent calculations are automatically done correctly.

⑬ Check if the Top Down Format and Side by Side Format Image are correct

when LOOP FORMAT is selected.

⑭ Check if the CINE/LOOP (Broken Image, Auto run, Auto run Speed and Track

ball Cine) and its related functions work properly.

Chapter 4. Checking the Product 4-13

CChhaapptteerr 55.. PPrroodduucctt SSttrruuccttuurree

5.1 Overview

Chapter 5 describes the internal structure and operation mechanism of SonoAce R3.
This chapter must be read for the product maintenance and upgrade.
SonoAce R3 is high technology ultrasound system.
It not only adopted 15 inch LCD monitor and provides high resolution ultrasound Image,

but also provides the premium grade system functions. T o improve the processing speed,
SAMSUNG MEDISON Co., Ltd. developed new interface to connect a latest PC and the
ultrasound system with its proprietary technology . The enhancement of processor speed
makes the system operations faster and reduces diagnosis time.

SonoAce R3 can use up to 96 Element probes and adopted Digital Beamforming of TX
32 Channels. Ultrasound image is displayed on the LCD through the Front End Part and
Back End Part (including PC Part).

The resolution of the LCD monitor is 1024 X 768 pixels and various image formats are
provided. The wide view angle of the LCD panel provides convenient work environment
for diagnosis.

The USB port are placed on the front panel of the system for easier image backup and
software service. Since this system supports various external storage devices such as
USB MO, USB Flash Memory and external-type USB HDD, upgrade becomes more
easier.

SonoAce R3 consists of the following major components.

z Ultrasound System Part : PSA, Main Board, Rear Board, PC Module
z Monit or Part
z Control Panel Part : Control Panel Board, Track Ball,
z Power Part

Chapter 5. Product structure 5-1

Contents

5.1 Overview ..................................................................................................5-1

5.2 System Block Diagram .............................................................................5-3

5.3 Basic Structure of SonoAce R3 ................................................................5-4

5.4 PSA (2 Port Option) ...................................................................................5-5

5.5 Beamformer Part .......................................................................................5-7

5.6 Back End Part .......................................................................................... 5-11

5.7 Rear Board ............................................................................................. 5-17

5.8 Control Panel .......................................................................................... 5-18

5.9 Power Supply ......................................................................................... 5-19

Chapter 5. Product structure 5-2

5.2 System Block Diagram

[Figure 5-1] System Block Diagram

Chapter 5. Product structure 5-3