Samsung HS40 Service manual

HS40

Service Manual

Version 1.00

HS40

Service Manual

English

SM-HS40-ENG-01

(Empty page)

Safety Requirements

 Classification

– Type of protection against electric shocks: Class I

– Degree of protection against electric shocks (when the patient is in physical contact):

Type BF or type CF mounting

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

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

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

– Mode of operation: Continuous operation

 Safety standards the device conforms to

– Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and

Essential Performance [IEC 60601-1:2005/A1:2012]

– Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and

Essential Performance - Collateral Standard: Electromagnetic Compatibility –
Requirements and Tests [IEC 60601-1-2:2007]

– Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and

Essential Performance - Collateral Standard: Usability [IEC 60601-1-6:2010]

– Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety

and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
[IEC 60601-2-37:200 7]

– Medical Electrical Equipment - Part 1: General Requirements for Safety [IEC 60601-

1:1988, A1:1991, A2:1995]

– Medical Electrical Equipment - Part 1-1: General Requirements for Safety – Collateral

Standards: General Requirements for Medical Electrical Systems [IEC 60601-1-1:2000]

– Medical Electrical Equipment - Part 1-2: General Requirements for Safety – Collateral

Standards: Electromagnetic Compatibility – Requirements and Tests [IEC 60601-1-
2:2001, A1:2004]

– Medical Electrical Equipment - Part 1-4: General Requirements for Safety – Collateral

Standards: Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999]

– Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety

and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment

[IEC 60601-2-37:200 1, A1:2004, A2:2005]

– Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]

– Medical Electrical Equipment - Part 1: General Requirements for Safety [UL 60601-

1:2003]

– Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and

Essential Performance[CAN/CSA C22.2 No. 60601-1:14]

– Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and

Essential Performance [ANSI /AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND
A2:2010(R)2012]

– Biological Evaluation of Medical Devices – Part 1: evaluation and testing [ISO 10993-1:

2009]

– Standard Means for Reporting the Acous tic Output of Medical Diagnostic Ultrasonic

Equipment [IEC 61157:2007]

 Sta te me nts

Nemk o-CCL mark with the indicators “C” and “US” means that
the product is certified for both the U.S. and Canadian markets,
to the applicable U.S. and Canadian standards.

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

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

The GMP symbol indicates the Good Manufacturing Practice in
accordance with the Korean quality management regulations .

Precautions for Use

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

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

• Please familiarize yourself with the safety precautions in “Chapter 2. Safety ” and “Chapter

10. Maintenance” in particular.

• This service manual does not inc lude diagnosis results or opinions. Also, check the
reference information for the measured area of the body before using the application’s
measurement results in any diagnosis.

• This product is an ultrasound diagnosis device and cannot be used from the user’s PC. The
manufacturer is not responsible for any problems that may be caused by s uch attempts.

• This product must only be used by persons who have sufficient knowledge of and/or a
qualification in clinical pathology. Unqualified persons are prohibited from us ing the product.

• The manufacturer is not responsible for any damage to this product caus ed by user
careless ness and/or neglect.

• Product orders are based on individually agreed specifications and may not include all
functions specified in this service manual.

• Some functions or options, probes, and the like may not be used in certain countries.

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

the public ation of this service manual.

• Screen images in this service manual are examples and may differ from the actual screen or
system.

• The content of this service manual is subject to change without prior notice.

• Products that are not manufactured by Samsung Medison are indicated with the trademarks

of their respective owners.

• The following terms are used to highlight precautions that the user must pay particular
attention to:

DANGER

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

WARNING

Follow these ins tructions to prevent a serious accident or damage to property.

CAUTION

Follow these ins tructions to prevent

NOTE

The accompanying information covers installation, operation, and maintenance
procedures that require careful attention from the user, but have little chance of leading

directly to a dangerous situation.

minor accidents and damage to property.

Revision History

The revis ion history of this servic e manual is as follows:

VERSION DAT E REASON FOR CHANGE

1.00.00 2017.04.01 Initial Release

If You Need Assistance

If you need a service manual or any assistanc e with the product, pleas e c ontact the Samsung
Medison customer service department or your local vendor.

Patient Privacy Policy

Treatment of Patients’ Personal Information

One of Samsung Medison’s s ocial responsibilities is to recognize the importance of patient
privacy and to handle and protect the personal information provided by our patients in an
appropriate manner.

Patient information stored in repaired and demo products should be handled as follows:

• Patient Information: Refers to information, such as IDs, names, DOBs, and images, which
can be us ed to identify specific patients.

• Patient Information Management: Personal information provided by patients mus t be
managed carefully and solely for the purposes of repairs and demonstrations of Samsung
Medison products, and they must not be used for unauthorized purposes, be lost, be revised,
or be shared with a third party.

Management of Patient Information on Demo and Trade Products

• Patient information stored on a product during the course of its use must be handled as the
patient des ires. (delete or backup)

• When completing a demonstration and/or collecting a trade product, patient information must
be deleted if so requested by the client, to prevent its unintended distribution to outs ide
parties .

Management of Patient Information on Repaired Hospital Products

• Before removing the product from hospital premises for repairs, all patient information should
be back ed up to a storage device such as external HDD or memory, and then handed over
to the hospital.

• Before removing the product from hospital premises, each patient should sign the patient
privacy agreement.

Request for Repairs and Patient Privacy Agreement

Date:

YY/MM/DD Name:

(Signature)

【Customer Information】

Hospital

Handler

【Product Information】

Product name

Software version

S/N

Symptom

Date: YYYY/MM/DD

Stored item

Outsourced product

【Adminis tration】

Handling date YY MM DD

Customer service
representative

※ Please sign ins ide the box below if you agree to the following:

□ Data saved on memory devic es of products being repaired (e.g., hard disks) may become

lost during tests and repairs.

□ Data saved on a product being repaired must be back ed up by the customer.

□ Samsung will not be held responsible for any loss of data not backed up.

□ Samsung Medison does not use patient information for unauthorized purposes, modify

such information, or provide it to third parties.

【Customer Signature】

□ None □ Main unit □ HDD □ DVD/CD

□ USB □ Photo □ Other ( )

□ None

□ Provide details if applicable ( )

I entrust my product to ( ) for repair and agree to the policies above.

Table of Contents 1

Table of Contents

Chapter 1 Introduction 1

1.1. Product Specification s............................................................................................. 2

1.2. Product Configuration ............................................................................................. 5

1.2.1. Monitor ........................................................................................................ 7

1.2.2. Control Panel ............................................................................................... 9

1.2.3. Cons ole ..................................................................................................... 16

1.2.4. Perip heral Devices ..................................................................................... 18

1.2.5. Probes....................................................................................................... 20

1.2.6. Accessories ............................................................................................... 22

1.2.7. Optional Acces sories .................................................................................. 23

1.2.8. Optional Functio ns ..................................................................................... 24

Chapter 2 Safety 1

2.1. Purpose of Use ........................................................................................................ 2

2.1.1. Contrain dications ......................................................................................... 2

2.2. Sa fe ty Information.................................................................................................... 3

2.2.1. Safety Symbols ............................................................................................ 3

2.2.2. Symbols ...................................................................................................... 7

2.2.3. Labels ......................................................................................................... 7

2.3. Electrical Safety ....................................................................................................... 8

2.3.1. Prevention of Electric Shocks ........................................................................ 8

2.3.2. ECG-Rel ated Informatio n ............................................................................ 10

2.3.3. ESD .......................................................................................................... 10

2.3.4. EMI ............................................................................................................11

2.3.5. EMC...........................................................................................................11

2.4. Mechanical Safety ...................................................................................................18

2.4.1. Moving the Eq uipm ent ................................................................................ 18

2.4.2. Precautions for Use .................................................................................... 19

2.5. Biological Safety .....................................................................................................22

2.5.1. ALARA Principl e......................................................................................... 22

2.6. Protecting the Environme nt ....................................................................................35

2.6.1. EU WEEE Directi ve .................................................................................... 35

2.6.2. EU REACH Regulation ............................................................................... 35

2.6.3. State of California Proposition 65 Warnin g ( US Only ) .................................... 35

2 HS40 Service Manual

Chapter 3. Installing Product 1

3.1. Transporting .............................................................................................................3

3.1.1. Precautions During Trans po rt ....................................................................... 3

3.1.2. Brakes ........................................................................................................ 3

3.1.3. Precautions on Ramps ................................................................................. 3

3.1.4. Humi dity and Temperatu re ............................................................................ 4

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

3.2.1. Dismantlin g the Product's Box ...................................................................... 5

3.2.2. Accessories ................................................................................................. 6

3.2.3. Release of the Locking Mecha nism ............................................................... 6

3.3. Installation Environment...........................................................................................7

3.3.1. Cauti on ....................................................................................................... 7

3.4. Installing the Product................................................................................................8

3.4.1. Installatio n Sa fety......................................................................................... 8

3.4.2. Connec ting P erip he rals ...............................................................................10

3.5. System Power ......................................................................................................... 13

3.5.1. Turnin g the Power On .................................................................................13

3.5.2. Shutting Down the System...........................................................................13

3.6. Sy stem Se tti ng s...................................................................................................... 14

3.6.1. General Sys tem Settings .............................................................................15

3.6.2. General ......................................................................................................15

3.6.3. Display .......................................................................................................19

3.6.4. Patient .......................................................................................................20

3.6.5. Quick Preset ...............................................................................................23

3.6.6. EzExam+....................................................................................................24

3.6.7. Imaging ......................................................................................................27

3.6.8. Application/Preset .......................................................................................30

3.6.9. Application..................................................................................................32

3.6.10. Measurement Settings.................................................................................33

3.6.11. Report ........................................................................................................49

3.6.12. Annotatio n ..................................................................................................52

3.6.13. Body Marker ...............................................................................................57

3.6.14. Customize ..................................................................................................60

3.6.15. Peripherals .................................................................................................64

3.6.16. Connecti vity ................................................................................................67

3.6.17. S e r vic e .......................................................................................................86

3.6.18. He

lp ...........................................................................................................86

Table of Contents 3

Chapter 4. Product Inspection 1

4.1. Inspecting Function s ............................................................................................... 2

4.1.1. Basic Inspections ......................................................................................... 2

4.1.2. Detail ed Inspec tions ..................................................................................... 3

Chapter 5. Product Structure 1

5.1. Overview .................................................................................................................. 3

5.2. System Block Diagram............................................................................................. 5

5.2.1. System Block Diagram ................................................................................. 5

5.2.2. System Rack Design .................................................................................... 6

5.3. Basi c Structure of the Product................................................................................. 7

5.3.1. Electronic Structure ...................................................................................... 7

5.3.2. Ultraso un d System Part ................................................................................ 7

5.3.3. PC Part ....................................................................................................... 8

5.3.4. User Inte rface Part ....................................................................................... 8

5.3.5. Powe r Part ................................................................................................... 8

5.4. Ultrasound System Part ........................................................................................... 9

5.4.1. Main Functions of PSA (Pr ob e Select Assembly) ............................................ 9

5.4.2. Beam Forme r Board ....................................................................................11

5.4.3. Back End Board ......................................................................................... 15

5.5. PC Part ....................................................................................................................20

5.5.1. PC Mod ule................................................................................................. 20

5.5.2. Rear IO Board............................................................................................ 21

5.5.3. Softw ar e DS C ............................................................................................ 23

5.6. User Interface Part ..................................................................................................24

5.6.1. Control Panel ............................................................................................. 24

5.6.2. Main Monitor .............................................................................................. 26

5.6.3. To u c h-Sc re en............................................................................................. 27

5.6.4. Display Layout ........................................................................................... 28

5.7. Power Part ..............................................................................................................29

5.7.1. ADM .......................................................................................................... 29

5.7.2. Power Block Diagram ................................................................................. 30

5.7.3. Specificatio n .............................................................................................. 30

5.8. Interconnect Diagram..............................................................................................31

5.8.1. HS40 Interconnect Diagram ........................................................................ 31

5.8.2. Cable Description ....................................................................................... 32

4 HS40 Service Manual

Chapter 6. Service Mode 1

6.1. Se rvice Mode ............................................................................................................3

6.1.1. How to Enter the Servic e Mode..................................................................... 3

6.2. Service Information ..................................................................................................4

6.3. Configuration ............................................................................................................5

6.3.1. Cloc k ........................................................................................................... 5

6.3.2. Keyboard/Region ......................................................................................... 5

6.3.3. TCP /IP ........................................................................................................ 6

6.3.4. Option ......................................................................................................... 7

6.3.5. User Acc ou nt and User Account Mana gem ent ............................................... 8

6.3.6. Printer ......................................................................................................... 9

6.4. System .................................................................................................................... 10

6.4.1. Upgra de Softw ar e .......................................................................................10

6.4.2. System Serial Num ber................................................................................. 11

6.4.3. Window Ex pl orer.........................................................................................12

6.4.4. Install R eco very System ..............................................................................13

6.5. Diagno stics............................................................................................................. 14

6.5.1. Control Panel Test .......................................................................................14

6.5.2. Keyboard Test.............................................................................................14

6.5.3. Power On Sel f Test .....................................................................................14

6.5.4. Built in Self Test ..........................................................................................14

6.5.5. Monitor Test ................................................................................................14

6.6. Backup and Restore ............................................................................................... 15

6.6.1. Backup .......................................................................................................15

6.6.2. Restore ......................................................................................................15

6.6.3. Log Backup ................................................................................................15

6.7. Report ..................................................................................................................... 16

6.7.1. Report ........................................................................................................16

6.8. Demo Play............................................................................................................... 17

6.8.1. Demo Play..................................................................................................17

6.9. Enter Installation Key.............................................................................................. 18

Table of Contents 5

Chapter 7. Troubleshooting 1

7.1. Power Issue s............................................................................................................ 2

7.1.1. Power Does Not Turn On .............................................................................. 2

7.1.2. Power Does Not Turn Off .............................................................................. 2

7.1.3. Power Turns Off by Its el f............................................................................... 2

7.2. Monitor..................................................................................................................... 3

7.2.1. Nothi ng Is Displ ay ed o n the Scre en ............................................................... 3

7.2.2. Screen is Discolor ed ..................................................................................... 3

7.3. Error Message s ........................................................................................................ 4

7.3.1. Erro r Occurs Durin g B oot ing ......................................................................... 4

7.4. Image ....................................................................................................................... 4

7.4.1. 2D Mode: There is No IMAGE ECHO or IMA GE FORMAT .............................. 4

7.4.2. Lines (Noise) Appea r in 2D Mode Ima ge ........................................................ 4

7.4.3. M, C, PW, CW Mode Trouble ........................................................................ 4

7.5. USB Drive Unre cognized.......................................................................................... 5

7.5.1. Failed to r ecog nize the USB ( Rem ovable device) device ................................ 5

7.6. Trouble Shooting Tree ............................................................................................. 6

Chapter 8. Disassembly and Assembly 1

8.1. Preparation .............................................................................................................. 2

8.1.1. Preparati on .................................................................................................. 2

8.2. Product Di sassembly ............................................................................................... 3

8.2.1. Front Sid e Disassembly ................................................................................ 3

8.2.2. Rear Side Disassembly ................................................................................ 6

8.2.3. Control Panel Disass em bly ........................................................................... 7

8.2.4. Touch Panel Disassembly ............................................................................. 8

8.2.5. Track Ball .................................................................................................... 9

8.2.6. Speaker Disassembly ................................................................................. 10

8.2.7. Monitor Disassembly ...................................................................................11

8.2.8. Monitor A RM Disassem bly .......................................................................... 12

8.3. Installation of Optional Parts ..................................................................................13

8.3.1. Overvie w of Optional Parts ......................................................................... 13

8.3.2. Option Pa rts............................................................................................... 14

8.3.3. Installatio n of External Physical Keyboard .................................................... 16

8.3.4. Installatio n of Gel Warme r ........................................................................... 16

8.3.5. Installatio n of Endo Cavity Holder ................................................................ 17

8.3.6. Installatio n of Holder Chart .......................................................................... 18

8.3.7. I

nstallation of Rear Tray .............................................................................. 18

6 HS40 Service Manual

8.3.8. Installatio n of Printer Tray (1/2) ....................................................................19

8.3.9. Installatio n o f Printer Tray (2/2) ....................................................................19

Chapter 9 Probes 1

9.1. Probes ......................................................................................................................2

9.1.1. Probe List .................................................................................................... 2

9.1.2. Ultraso un d Transmission Gel ........................................................................ 9

9.1.3. Sheaths ......................................................................................................10

9.1.4. Probe Safety Precautio ns ............................................................................ 11

9.1.5. Cleanin g an d Disinfecting th e Probe.............................................................13

9.2. Bi o p sy ..................................................................................................................... 22

9.2.1. Biopsy Kit Compon ents ...............................................................................22

9.2.2. Using the Bio psy Kit ....................................................................................23

9.2.3. Assembling the Biopsy Kit ...........................................................................26

9.2.4. Cleanin g an d Disinfecting th e Biopsy Kit.......................................................30

10. Maintenance 1

10.1. Operational Environment ..........................................................................................2

10.2. Product Maintena nce ................................................................................................3

10.2.1. Clea ning and Disinfecting ............................................................................. 3

10.2.2. Clea ning...................................................................................................... 3

10.2.3. Cleaning Air Filters ....................................................................................... 5

10.2.4. Accuracy Checks ......................................................................................... 6

10.3. Data Maintenance .....................................................................................................7

10.3.1. User Settings Backup ................................................................................... 7

10.3.2. Backing Up Patie nt Information ..................................................................... 7

10.3.3. Software...................................................................................................... 7

Chapter 11. Service Part List 1

11.1. Body Cover Parts......................................................................................................2

11.2. Control Panel Pa rts...................................................................................................5

Chapter 1

1.
Chapte r 1 I ntroduc tion

Introduction

1.1. Product Specifications .............................................................................................. 2

1.2. Product Configuration ............................................................................................... 5

1.2.1. Monitor........................................................................................................... 7

1.2.2. Cont rol Pan el ................................................................................................. 9

1.2.3. Cons ole ....................................................................................................... 16

1.2.4. Peripheral D e vices ........................................................................................ 18

1.2.5. Prob es ......................................................................................................... 20

1.2.6. Accessories.................................................................................................. 22

1.2.7. Optional Access ories .................................................................................... 23

1.2.8. Optional Functions ........................................................................................ 24

1 – 2 HS40 Service Manual

1.1. Product Specifications

Height: 1,620 mm (with Monitor)

Physical

Dimensions

Imaging Modes

Width: 520 mm

Depth: 730 mm (with Keyboard)

Weight: 54 kg (without acces sories)

Weight: Approx. 57 kg (with Safe Working Load)

2D Mode

M Mode

Color M Mode

Anatomical Mode

Color Doppler Mode

Pulsed W ave (PW) Spectral Doppler Mode

Continuous W ave (CW) Doppler Mode

Tissue Doppler Imaging (TDI) Mode

Tissue Doppler Wave (TDW) Mode

Power Doppler (PD) Mode

ElastoScan Mode

3D/4D/XI STIC imaging Mode

Dual Mode

Quad Mode

Combined Mode

Simultaneous Mode

Zoom Mode

Gray Scale 256 (8 bits )

Transmit focusing, maximum of eight points (four points simultaneously

Focusing

Probes

(Ty pe BF/IPX7)

selectable)

Digital dynamic receive focusing (continuous)

Linear Array

LA3-16AD

Curved Array

CA2-8AD, CF4-9

Phased Array

PN2-4

Endo Cavity

EVN4-9

3D

VN4-8, V5-9

Pe ncil

DP2B

Chapter 1. Introduction 1 – 3

Probe

Connections

Monitor

ECG USB Type (Type CF)

Rear Panel

Input/Output

Connections

3 Probe Connectors, 4 Probe Connectors for option

CW Probe Connector

Main Monitor

Number of Pix el: 1920 x 1080

21.5 inch LCD Monitor (LED Backlight unit, hereafter referred to as “LCD
monitor”)

Touch Screen Monitor

Number of Pix el: 1280 x 800

10.1 inch LCD Monitor (LED Backlight unit, hereafter referred to as “LCD
monitor”)

Audio Output Port (Right/Left)

VGA monitor

LAN

USB Port

CW

HDMI output

HDMI Input (HDMI Input is currently not s upported.)

Image Storage

Application

Electrical

Parameters

Measurement

Packages

Signal

Processing

(Pre-process ing)

Maximum 45,000 frames for Cine memory

Maximum 14,000 Lines for Loop memory

Image filing s ystem

Obstetrics, Gynecology, Urology, Abdomen, Cardiac, Vascular, Small
Parts, TCD, MSK, Pediatric

100 - 240VAC, 620VA, 50/60Hz

Abdomen, Obs tetrics, Gynecology, MSK, Pediatric, Small Parts, Urology,
Vascular, Cardiac

* Refer to the ‘Chapter 8. Measurements and Calculations’ for additional
information.

Acoustic Power Control

Analog TGC Control

Dynamic Aperture Control

Dynamic Apodization Control

1 – 4 HS40 Service Manual

Dynamic LPF Control

Digital TGC Control

Slider TGC Control

Mode-Independent Gain Control

Black Hole/Noise Spike Filtering

Signal

Processing

(Pos t-

processing)

Measurement

1D Lateral/Axial Filtering

2D Edge/Blurring Filtering

Frame average

M/D Mode Sweep Speed Control

Zoom

Image View Area Control

Image Orientation (left/right and up/down)

Trackball operation of multiple cursors

• 2D mode: Linear measurements and area measurements using
elliptical approximation or trace

• M mode: Continuous readout of distance, time, and slope rate

• Doppler mode: Velocity and trace

DVD Multi-Dr i ve

Digital B/W Video Printer

Digital Color Video Printer

USB Printer

Auxiliary

User Interface English, German, French, Spanish, Italian, Russ ian, Chinese, Portuguese

Pressure Limits

Humidity Limits

Temperature

Limits

DVD Recorder

Foot switch (IPX8)

USB Flash Memory Media

USB HDD

USB ECG

Monitor

Operating: 700 – 1060hPa

Storage: 700 – 1060hPa

Operating: 30 – 75%

Storage & Shipping: 20 – 90%

Operating: 10 – 35°C

Storage & Shipping: -25 – 60°C

Chapter 1. Introduction 1 – 5

1.2. Product Configuration

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

① Monitor

② Monitor arm

③ Touch Panel

④ Speaker

⑤ Control Panel & Handle

⑥ USB port

⑦ Probe holder

⑧ Lift & Lift Lever

⑨ ECG port

⑩ Outlet for internal peripheral

devices

[Figure 1.1 Front of the Product]

⑪ Probe port

⑫ CW Port

⑬ Wheel

⑭ Brake

⑮ Filter

1 – 6 HS40 Service Manual

① Storage compartments

② Ventilation

③ Cable holder

④ Rear panel

⑤ ID label

⑥ Power connection

[Figure 1.2 Back of the Product]

Chapter 1. Introduction 1 – 7

1.2.1. Monitor

Ultrasound images and other information are displayed on the color LCD monitor.

1.2.1.1. Screen Layout

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

[Figure 1.3 Monitor Display]

① Title Area

Displays patient information, hospital n ame, a pplicatio n, frame rate, dept h, probe i nform ation,
acoustic output information, and the current date and time.

② Image Area

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

③ Thumbnail Area

Images s aved by pressing the preset Store button are shown in the thumbnails. When you
save Single sc reens, up to 4 images are shown in a list; for Quad screens, up to 12 images
are shown. Click it with the pointer to enlarge the preview image.

④ User Information and Status Information Area

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

⑤ User Key (User Defined Key) Area

Settings for User Defined Key s, including the positions of Set and Ex it buttons, are
displayed. You can change the setting of each button in Setup > Customize > Buttons.

1 – 8 HS40 Service Manual

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

NOTE

TIP

Principles of Operation of the Diagnostic Ultrasound System

Medical ultrasound images are created by digital memory and computer when they
convert the high-frequency wave signals that are transmitted and received by the
probe.

As ultrasound waves propagate through the human body, they generate reflected
signals whenever they encounter a change in density. For example, reflected
signals are generated when signals pass from fatty tissues to muscle tissues.
Reflected signals return to the probe, where they are converted into electronic
signals. The reflected signals are amplified and processed by analog and digital
circuits that have filters for various frequencies and response time options. Then
they are again converted into high-frequency elec tronic signals, and saved as a
series of digital image signals. The monitor displays the image signals stored on the
storage device in real time. The entire process of transmitting, receiving, and
processing signals is controlled by the computer.

1.2.2. Control Panel

The system can be controlled by using the control panel.

Chapter 1. Introduction 1 – 9

[Figure 1.4 Control Panel]

The control panel consists of a soft menus, buttons, dials, dial-buttons, a slider, and a trackball.

The dial-button can be used both as a dial and a button.

1 – 10 HS40 Service Manual

1.2.2.1. Functions of the Control Panel

The following are the descriptions and instructions for the controls on the control panel. For
more information on controls with multiple functions, s ee ‘Chapter 3. Utilities’ and later in this

manual.

Button Turns the system on/off.

On/Off

End Exam

SonoView

Report

EzExam

Button

Finishes the exam of the currently selec ted patient and resets
the related data.

Button Displays the screen for viewing and managing stored images.

Button

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

When you press the dial-button, the menu items that are
available in the current scan mode are shown on screen.

Dial-button

Rotating the EzEx am dial-button to the right s elects the menu
one row above the current menu selected, and rotating it to the
left selec ts the menu one row below.

Button Allows the user to enter a Body Marker over an image.

Adjusts the angle of the sample volume in Spectral Doppler
mode. It is also used to adjust the Arrow’s angle or the probe

Dial-button

angle for a Body Marker.

In 3D View, turning this dial-button will rotate the image around
the x-axis.

Dial-button

Dial-button

Enter or exit PW Spectral Doppler Mode. Rotate this dial­button to adjust the Gain value.

In 3D View, turning this dial-button will rotate the image around
the y-axis.

Enter or exit Color Doppler Mode. Rotate this dial-button to
adjust the Gain value.

In 3D View, turning this dial-button will rotate the image around
the z-axis.

Chapter 1. Introduction 1 – 11

Dial-button

Button

Button

Button Enter or exit Power Doppler Mode.

Button Use this button to enter or exit 3D or 4D Mode.

Button

Press this button to enter 2D Mode. Rotate this dial-button to
adjust the Gain value.

Enter or exit M Mode. Rotate this dial-button to adjust the Gain
value.

Enter or exit CW Spectral Doppler Mode. Available only with
the phased array probe.

Press this button to turn the Quick Sc an function on. The ‘Q
scan’ mark will appear at the top of the image. This can be
used in applications for all probes.

Button

Button

Switch Adjusts the scanning depth of the image.

Switch Moves the focus to the target area for observation.

Dial-button

Compares two independent images. The active image mode is
shown on the left.

Compares two independent images. The activated image
mode is shown on the right.

Makes the Zoom Box appear. In order to exit Zoom Mode,
press the Ex i t button.

1 – 12 HS40 Service Manual

Set/Exit

Clear

Pointer

Change

Button

Button

Button

Button

Button

Button

Pauses an image being scanned or reactivates a paused
image.

Stands for User Key ; the user c an assign functions they need
to each button. The function for each button can be ass igned
in Setup > Customize > Buttons.

The user can select, set up, and use Set/Set, Se t/Ex it, or
Exit/Set. The function for each button can be assigned in
Setup > Customize > Buttons.

– Set: Selects an item or value using the trackball.

Alternatively, this can be us ed to change the function of the
trackball.

– Exit: Exits the function currently being used and returns to

the previous screen.

Deletes t ext, Arrows, Body Markers, measurement results,
etc., display ed on an image.

In Scan Mode, an arrow-shaped pointer appears on the
screen.

Changes to a different function that can be s upported by the
current trackball setting.

Calculator

Trackball

Button Allows the user to place text over an image.

Button Starts measurements by application.

Trackball

Moves the cursor on the sc reen. Also, scrolls through Cine
images.

Chapter 1. Introduction 1 – 13

For further details about setting up Quick Preset, please refer to ‘Setup >
System > Quick Preset’ in ‘Chapter 3. Utilities’.

1.2.2.2. Touch Screen

The touch s creen is an operating tool that can be touched by the user to input data. The functio
ns that are available in the current mode are shown in the form of buttons or a dial-button.

■ Touch Screen Layout

[Figure 1.5 Touch Screen Display]

① These buttons are always display ed on the touch screen. Buttons that are in use are

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

Patient

Probe

Quick Preset

1–4

Setup

NOTE

The Patient Information screen will appear, where y ou can select a
Patient ID in the list or enter new patient information.

It displays the Probe Selection screen where you can select and
modify the probe and application.

It shows up to 4 Preset buttons c onfigured at Setup.

The general s ystem settings that do not have a direct bearing on
imaging are explained below.

1 – 14 HS40 Service Manual

CAUTION

Too great a difference in the gain value settings of adjacent TGC sliders may
cause stripes in an image.

② Displays the mode that is c urrently used.

③ This is the Keyboard button. Clicking this button will activate the On-screen Keyboard.

④ This is the TGC area. Adjust TGC Slide when TGC Curve is activated on the touch

screen. Move the slider to the right to increase Gain and brighten the image. TGC stands
for Time Gain Compensation.

⑤ Menu Area: The menu items that are available in the current input mode are shown in the

form of buttons. The user can access the desired menu item by pressing the
corresponding button. The menu currently in use is shown in blue. To change the values

in the menu, use the ◁ and ▷ buttons.

⑥ Soft Menu Area: The Soft Menu items that are available in the current input mode are

shown. Press or rotate the dial-buttons right below each menu.

TIP

When there are Two Soft Menus

When there are two menus available - upper and lower, both menus can be
adjusted with the corresponding dial-button. Or tap the button for the menu you
want to use on the touch screen and then us e the dial-button.

1.2.2.3. Adjusting the Control Panel

CAUTION

•

•

You can move the control panel up and down only while pulling the lever at the
side of the control panel.

Do not apply excessive force to the control panel.

Use the handles on the console when moving the product.

■ Adjusting the Height

Chapter 1. Introduction 1 – 15

[Figure 1.6 Control Panel]

NOTE

1 – 16 HS40 Service Manual

1.2.3. Console

The console consists of two parts - the inner and outer units. The interior of the console mainly
contains devices that produce ultrasound images. On the exterior of the console are various

connectors, probe holders, storage compartments , handles, and wheels, etc .

1.2.3.1. Rear Panel

A monitor and other peripheral devices, like a printer, are connected via the rear panel at the ba
ck of the system.

① Audio port (Output): Used for audio signal output.

(Input: Not supported.)

② S-VHS Port (Output): Provides an S-VHS

connection for a VCR.

③ RGB Port (Output): Provides analog signal output

to be displayed on the monitor.

④ USB port: Used to connect to peripheral USB

devices.

⑤ Network port: Connect to a network. You can

transfer patient information to another server via
DICOM network.

[Figure 1.7 Rear Panel]

⑥ HDMI port (Output): Outputs digital signals to the

monitor. (Input: Not supported.)

⑦ Trig port (In/Output): Not used.

Chapter 1. Introduction 1 – 17

1.2.3.2. Power Connection Part

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

[Figure 1.8 Power Connection Part]

① Power switch: Turns on the power of the product, and cuts off power if overcurrent or

overvoltage occurs.

② Power inlet: Accepts the power cord, which connects to an external power supply.

③ Power fuse: Cuts off power if overcurrent or overvolta ge occ urs.

④ Equipotential Terminal: This should be connected to the equipotential connection part in the

exam room.

1.2.3.3. Probe Holder

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

The holders can be removed for easy cleaning.

TIP

Hockey Stick Probe Holde r

Insert the Hockey stick probe holder into the probe holder to mount. It is provided as
an option.

1 – 18 HS40 Service Manual

•

•

•

1.2.4. Peripheral Devices

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

Do not install peripheral devic es that are not listed in this user manual in the

patient environment. If y ou install an unlisted device in the patient
environment, it may cause an electrical hazard.

CAUTION

Do not c onnect additional external peripheral devices to the auxiliary socket

outlet. Doing s o may decrease safety level.

[Figure 1.9 Patient Environment]

Refer to the user manual of the peripheral device for its operating information.

NOTE

1.2.4.1. Internal Peripheral Devices

These are peripheral devices mounted in the sys tem.

■ DV D-Multi

DVD±R, DVD±RW, DVD-RAM, CD-R, CD-RW

■ Soli d Sta te Drive

SSD 512G

Chapter 1. Introduction 1 – 19

CAUTION

When using a peripheral device via a USB port, always turn the power off before
connecting/disconnecting the device. Connection/disconnection of USB devices
while the power is on may lead to malfunction of the s ystem and the USB
devices.

•

•

• Please check the port that the printer uses before connec ting. Printers should
be connected to the printer port while the USB printer should be c onnected to

1.2.4.2. External Peripheral Devices

These are peripheral devices that can be connec ted for use when needed and are connected
via the USB port located at the rear panel.

TIP

The following products are recommended:

■ Digital Video Printer

• Black and White: Sony UP-D897 (UP-897MD, UP-X898MD, UP-D898MD), Mitsubishi

• Color: Sony UP-D25MD, Mitsubis hi CP30DW

■ US B Pri nter

Samsung CLP-620NDK, Samsung ML-2950

■ DV D Re corde r

Sony DVO-1000MD

CAUTION

• The console’s USB ports are located on the rear panels of both the control panel
and the console.

• W e recommend that you connect USB storage devices (flash memory media,
etc.) to the ports on the c ontrol panel, and other USB peripheral devices to the
rear panel for convenience.

P95DE (P95DW, P95D, P95DE)

You must install a printer and drivers that are compatible with Microsoft

Windows 7 (Englis h version). Contact Samsung Medison customer support
division for inquiries about printer driver installation.

When connecting the printer, ensure that the printer is configured under

Microsoft W indows or system setup and has been chosen as the default
printer.

the USB port.

■ Foot Switch

• 3 Pedals HID Type

To configure the foot s witch function, go to Setup > Customize > Buttons > Foot Switc h.

You can individually set the Left, Middle, and Right foot s witches to one of the following:
Exi t, Freeze, U1, U2, U3, U4, Update, Single, or Quad.

1 – 20 HS40 Service Manual

CAUTION

Connecting or removing the Foot Switch while the product is turned on may
cause the sys tem to malfunction.

•

•

•

For information on probes, refe
Manual.

If the probe
foreign objects.

■ M i sc.

Flash Memory Media

The system cannot recognize USB 1.1 flash memory. Remove the flash

memory from the console and equip again with an appropriate device.

Regarding file formats that are not ordinarily saved: Please chec k first to see

NOTE

if it is possible to save the file format on a desktop PC before trying to save
the file on flash memory.

Do not use flas h memory media which contain anti-virus programs or are

defective. Otherwis e, the product may fail to work properly.

1.2.5. Probes

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

r to ‘Chapter 9. Probes’ and the Reference

NOTE

1.2.5.1. Connecting Probes

Be sure to connec t or disconnect probes when the power is off to ensure the safety of the syste
m and the probes.

1. Connect probes to the probe connectors on the front panel of the system. Up to four (options
inclusive) (five including CW) probes may be connected.

2. Lift up the probe’s lockdown switch and disconnect the probe.

3. Connect the probe to the probe port.

4. Push down the probe’s lock down switch to lock it in place.

does not connect properly, try reconnecting it after removing any

NOTE

[Figure 1.10 Probe Connector]

Chapter 1. Introduction 1 – 21

1 – 22 HS40 Service Manual

Accessories c an be

1.2.6. Accessories

An accessory box containing the items below is supplied with the product.

different according to the country.

NOTE

[Figure 1.11 Accessories]

Chapter 1. Introduction 1 – 23

1.2.7. Optional Accessories

The following optional accessories are provided with the product.

1 – 24 HS40 Service Manual

•

•

•

•

•

•

•

•

•

1.2.8. Optional Functions

HS40 products have the following options based on the version:

• 4D

• 3D XI™

• DICOM

• EzExam+

• MultiVision

• 5D NT

• CW Function

• Cardiac Measurement

• Strain+

For further information about optional functions, please refer to the relevant chapters in this
manual.

XI STIC

SEE Stream (RU region only)

Needle Mate

Realistic Vue

Mobile Export

5D Follicle

Auto IMT+

ElastoScan

Panoramic

Chapter 2

2. Sa fety
Chapte r 2 S afety

Safety

2.1. Purpose of Use ...........................................................................................................2

2.1.1. Cont rain dications ............................................................................................2

2.2. Safe ty Informa tion ......................................................................................................3

2.2.1. Safety Symbols ...............................................................................................3

2.2.2. Symbols .........................................................................................................7

2.2.3. Lab els ............................................................................................................7

2.3. Electrical Safety..........................................................................................................8

2.3.1. Prevention of Electric Shocks ...........................................................................8

2.3.2. ECG-Rel ated Information ............................................................................... 10

2.3.3. ESD ............................................................................................................. 10

2.3.4. EMI .............................................................................................................. 11

2.3.5. EMC............................................................................................................. 11

2.4. Mechanical Safety .................................................................................................... 18

2.4.1. Movi ng the Equipm ent ................................................................................... 18

2.4.2. Precautions for Use ....................................................................................... 19

2.5. Biological Safety....................................................................................................... 22

2.5.1. ALARA Principl e ............................................................................................ 22

2.6. Protecting the Environment...................................................................................... 35

2.6.1. EU WEEE Directive ....................................................................................... 35

2.6.2. EU REACH Reg ulation .................................................................................. 35

2.6.3. State of Cali fornia Prop osition 65 Warning (US Only) ....................................... 35

2 – 2 HS40 Service Manual

For detailed information on applications and presets, please refer to ‘Chapter
Introduction’ and ‘Chapter

CAUTION

•

•

2.1. Purpose of Use

Ultrasound diagnostic system and probes were designed for obtaining ultrasound images and
analyzing body fluid.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small
Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal

(Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

9. Probes’ in this user manual.

NOTE

2.1.1. Contraindications

This product must not be used for ophthalmological applications, or any other use that involves
the ultrasound beam passing through the eye.

Federal law restric ts this devic e to sale by or on the order of a physician.

The method of application or use of the device is described in the manual

‘Chapter 6. Starting Diagnos is’ and ‘Chapter 7. Diagnosis Modes’.

1.

Chapter 2. Safety 2 – 3

2.2. Safety Information

Please read the following safety information before using this product. It is relevant to the
ultrasound s ystem, the probes, the recording devices, and any of the optional equipment.

The product is intended for use by, or by the order of, and under the supervision of, a licensed
physician who is qualified for direct use of the medical device.

2.2.1. Safety Symbols

The International Electro Technical Commiss ion (IEC) has established a set of symbols for
medical electronic equipment, which c lass ify a connection or warn of potential hazards. The
classifications and symbols are shown below.

Symbols Description

WARNING: The acc ompanying information must be followed to
prevent serious accidents and/or damage to property.

CAUTION: The accompanying information helps to prevent minor
accidents and/or damage to property.

Refer to the user manual.

Follow the user manual.

CAUTION: Risk of electric shock

Type BF applied part (Classification based on degree of protection
against electric haz ard)

Defibrillation-proof type CF applied part (Classification bas ed on
degree of protection against electric hazard)

Power On/Off

2 – 4 HS40 Service Manual

Symbols Description

Power On

Power Off

V~

Power On for part of the product

Power Off for part of the product

Alternating current voltage source

Direct current voltage source

Dangerous voltage (Indicates dangerous voltages over 1000V AC or
1500V DC)

Protective earth (ground)

Equipotentiality

Data output port

Data input port

Data Input/Output port

Symbols Description

IPX 1

IPX 7

IPX 8

Chapter 2. Safety 2 – 5

Output port

Input port

Print remote output

Foot Switch Port

ECG port

USB port

Network port

Microphone Port

Probe port

Protected against vertically falling water drops

Protected against the effects of temporary immersion in water

Protected against the effects of continuous immersion in water

CAUTION: Elec trostatic sensitive devices (ESD)

Do not sit on the product.

2 – 6 HS40 Service Manual

Symbols Description

Do not push the product.

Do not lean against the product.

DANGER: Do not place your fingers, hands , or any other part of your
body in this spac e.

Do not place objects on the monitor that are heavier than the weight
specified by the symbol.

Do not place heavy objec ts on the monitor while the monitor mount is
folded.

Do not push down on the monitor while the monitor mount is folded.

Chapter 2. Safety 2 – 7

2.2.2. Symbols

Symbols Description

Authorised Representative In The European Community

Manufacturer

2.2.3. Labels

Phrases containing the words ‘warning’ and/or ‘caution’ are display ed on the product’s surface
in order to protect it.

2 – 8 HS40 Service Manual

•

•

2.3. Electrical Safety

This equi pment is categorized as a Cl ass I device with Typ e BF or Ty pe CF (ECG) appli ed parts .

As for US requirement, the LEAKAGE CURRENT might be measured from a

center-tapped circuit when the equipment connects in the United States to
240V supply system.

CAUTION

2.3.1. Prevention of Electric Shocks

In a hospital environment, hazardous current c an form due to potential differences between
exposed conductive parts and connected devices. The solution to the problem is consistent
equipotential bonding. Medical equipment is connected with connecting leads made up of

sockets which are angled to the equipotential bonding network in medical rooms.

To help assure grounding reliability, connect to a “hospital grade” or “hospital

only” grounded power outlet.

[Figure 2.1 Equipotential Bonding]

Additional equipment c onnected to medical electrical equipment must comply with the
respective IEC standards (e.g. IEC 60950/EN 60950 for data processing equipment, IEC 60601­1/EN 60601-1 for medical devices). Furthermore, all configurations shall comply with the
requirements for medical electrical systems (see IEC 60601-1-1/EN 60601-1-1). Any body
connecting additional equipment to signal input and output ports of medical electrical equipment
should make sure that the equipment complies with IEC 60601-1-1/EN 60601-1-1.

Chapter 2. Safety 2 – 9

•

cluding all of its externally mounted

• Never open the cover of the product. Hazardous voltages are present inside.

•

•

•

•

•

•

uipment. HF surgical equipment may

•

•

•

•

•

•

•

•

Electric shock may result if this system, in

recording and monitoring devices, is not properly grounded.

WARNING

CAUTION

All internal adjustments and replacements must be made by qualified
Samsung Medison Customer Support Department personnel.

Always check the product’s housing, cables, cords, and plugs before using

the product. Disc onnect the power source and do not use the equipment if
the housing is damaged such as cracked, and chipped, or if the cable is
worn.

Always disc onnect the system from the wall outlet prior to cleaning the

system.

All patient contac t devices, s uch as probes and ECG leads, must be

removed from the patient prior to application of a high voltage defibrillation
pulse.

The use of flammable anesthetic gas or oxidizing gases (N2O) should be

avoided. There is a risk of explosion.

Avoid installing the s ystem in such a way that it is difficult for the operator to

disconnect it from the power source.

Do not us e together with HF surgical eq

be damaged, which may result in fire.

The system must only be c onnected to a supply mains with protective earth

to avoid risk of elec tric shock.

The system has been designed for 100-240VAC; you should selec t the input

voltage of any connected printer and VCR. Prior to connecting a peripheral
power c ord, verify that the voltage indicated on the power cord matches the
voltage rating of the peripheral device.

An isolation transformer protects the system from power surges. The

isolation transformer continues to operate when the sy stem is in standby.

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

Make sure that the inside of the system is not exposed to or flooded with

liquids. In such cases, fire, electric shock, injury, or damage to the product
may occur.

The auxiliary socket outlets installed on this sys tem are rated 100-240VAC

with maximum total load of 150VA. Use these outlets only for supplying
power to equipment that is intended to be part of the ultrasound sys tem. Do
not connect additional multiple-socket outlets or extension cords to the
system.

Do not c onnect any peripheral devices that are not listed in this manual to

the auxiliary socket outlet of the system. It may cause an electrical hazard.

Do not touch SIP/SOP and the patient simultaneously. There is a risk of

electric shock from leakage current.

2 – 10 HS40 Service Manual

• This device is not intended to provide a primary ECG monitoring function, and

•

•

•

•

•

•

2.3.2. ECG-Related Information

therefore does not have means of indicating an inoperative
electrocardiograph.

WARNING

Do not use ECG electrodes with HF surgical equipment. HF surgical

equipment may be damaged, which may result in fire.

Do not use ECG electrodes during c ardiac pacemaker procedures or any

procedures that involve other ty pes of electrical s timulators.

Do not us e ECG leads and electrodes in an operating room.

2.3.3. ESD

Electrostatic disc harge (ESD), commonly referred to as a static shock, is a naturally oc curring
phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by
heating or air conditioning. The s tatic shock or ESD is a discharge of the electrical energy build­up from a charged individual to a less or non-charged individual or object. An ESD occurs when
an individual with an electrical energy build-up comes into c ontact with conductive objects suc h
as metal doorknobs, file cabinets, computer equipment, and even other individuals.

The level of electrical energy discharged from a system user or patient to an

ultrasound system can be significant enough to cause damage to the system
or probes.

CAUTION

Always perform the pre-ESD preventive procedures before using connectors

marked with the ESD warning label.

– Apply anti-static spray to carpets or linoleum.

– Use anti-static mats.

– Ground the product to the patient table or bed.

It is highly recommended that the user be given training on ESD-related

warning symbols and preventive procedures.

Chapter 2. Safety 2 – 11

CAUTION

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

2.3.4. EMI

Although this system has been manufactured in c omplianc e with existing EMI (ElectroMagnetic
Interface) requirements, use of this system in the presence of an electromagnetic field can
cause degradation of the ultrasound image or product damage.

If this occ urs 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 elec trical 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 c ause

interference.

2.3.5. EMC

The testing for EMC (Electromagnetic Compatibility) of this system has been performed
according to the international standard for EMC with medic al devic es (IEC 60601-1-2). This IEC
standard was adopted in Europe as the European norm (EN 60601-1-2).

2.3.5.1. Guidance and Manufacturer ’s Declaration – Electromagnetic Emission

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

Em i ssi on Te st Compliance Electromagnetic Environment – Guidance

RF Emission

CISPR 11

RF Emission

CISPR 11

Harmonic Emission

IEC 61000-3-2

Flicker Em ission

IEC 61000-3-3

Group 1

Class A

Class A

Complies

The Ultrasound System uses RF energy only for its
internal functions . 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 other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.

2 – 12 HS40 Service Manual

CAUTION

When connecting other customer
user’s responsibility to ensure the electromagnetic compatibility of the system.

WARNING

The use of cables, probes, and peripherals other than those spec ified may result
in increased emission or decreased Immunity of the Ultra

2.3.5.2. Approved Cables, Probes and Peripherals for EMC

■ Cables

Cables connec ted to this product may affect its emissions; us e only the cable types and
lengths listed in the table below.

Cable Typ e Length

VGA Shielded Normal

USB Shielded Normal

LAN(RJ45) Twisted pair Any

S-Video Shielded Normal

Foot Switch Shielded 2.99m

Audio R.L Shielded Normal

Parallel Shielded Normal

HDMI Shielded Normal

ECG 3-lead Shielded Normal

■ Probes

The image probe used with this product may affect its emission. The probe listed in ‘Chapter

9. Probes’ when used with this product, have been tested to comply with the group1 Clas s A
emission as required by International Standard CISPR 11.

■ Peripherals

Peripherals used with this product may affect its emiss ions.

-supplied accessories to the system, it is the

sound System.

Chapter 2. Safety 2 – 13

Immunity Test

Electrostatic
discharge
(ESD)

IEC 61000-4-2

Electrical fast
transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

IEC 60601 Test

Level

±6KV Contact

±8KV Air

±2KV

for power supply
lines

±1KV

for input/output lines

±1KV differential
mode

±2KV common mode

Compliance Level

±6KV Contact

±8KV Air

±2KV

for power supply lines

±1KV

for input/output lines

±1KV differential
mode

±2KV common mode

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.

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

<5% Uт for 0.5 cycle

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

IEC 61000-4­11

Power
frequency
(50/60Hz)
magnetic field

IEC 61000-4-8

NOT E: Uт is the AC mains voltage prior to applic ation of the test level.

(>95% dip in Uт)

40% Uт for 5 cycle

(60% dip in Uт)

70% Uт for 25 cycle

(30% dip in Uт)

<5% Uт for 5 s

(<95% dip in Uт)

3 A/m 3 A/m

<5% Uт for 0.5 cycle

(>95% dip in Uт)

40% Uт for 5 cycle

(60% dip in Uт)

70% Uт for 25 cycle

(30% dip in Uт)

<5% Uт for 5 s

(<95% dip in Uт)

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

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

2 – 14 HS40 Service Manual

a

Immunity

Te st

Conducted
RF

IEC 61000-4­6

Radiated RF

IEC 61000-4­3

IEC 60601 Test

Level

3 Vrms

150 kHz to
80MHz

3 V/m

80 MHz to

2.5GHz

Compliance

Level

Electromagnetic Environment –

Guidance

3V Portable and mobile RF c ommunications

equipment should not be used 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 Distanc e

80MHz to 800MHz

800MHz to 2.5GHz

3V/m Where P is the transmitter’s maximum

output power rating in watts (W ) according
to the transmitter’s manufacturer, and d is
the recommended separation distanc e in
meters (m).

Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surve y ,
compliance level in each frequency range.

b

a

should be les s than the

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

NOT E 1) At 80MHz and 800MHz, the higher frequency range applies.

NOT E 2) These guidelines may not apply in all s ituations . Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

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 ass ess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in whic h 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 s trengths s hould be less than 3V/m.

Chapter 2. Safety 2 – 15

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73 1 1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

CAUTION

If the s ystem is connected to other customer
l
equipment will work correctly in the presence of electromagnetic emiss ion
phenomena.

2.3.5.3. Recommended Distance Between Wireless Communication Device and this Product

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 to 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.

Rated Maximum

Separation Distance According to Frequency of Transmitte r (m)

Output Pow er of

Transmitte r

150kHz to 80MHz

80MHz to 800MHz

800MHz to 2.5GHz

(W)

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated by us ing 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.

NOT E 1) At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.

NOT E 2) These guidelines may not apply in all s ituations . Electromagnetic propagation is
affec ted by absorption and reflection from structures, objects and people.

2.3.5.4. Electromagnetic Environment – Guidance

It is recommended to use ultrasound sys tems in shielded locations offering RF shielding
effectiveness, with shielded cables. 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 ensure that they meet the minimum specification.

ocal area network (LAN), Samsung Medison cannot guarantee that the remote

-supplied equipment, such as a

2 – 16 HS40 Service Manual

2.3.5.5. Avoiding Electromagnetic Interference

Typic al interference on Ultrasound Imaging Systems varies depending on Electromagnetic
phenomena. Please refer to the following table:

Imaging Mode

2D

M

Color

ESD1 RF2 Power Line3

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

Brief flashes in the
displayed or
recorded image.

For sector imaging
probes, white radial
bands or flashes in the
centerlines of the
image.

For linear imaging
probes, white vertical
bands, sometimes
more pronounced on
the sides of the image.

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.

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

White dots , dashes,
diagonal lines, or
increase in image
background nois e

Color flashes, dots,
dashes, or changes in
the color noise level.

Horizontal lines in the

Doppler

spectral display or
tones, abnormal noise
in the audio, or both.

1. ESD caused by discharging of electric charge build-up on insulated surfaces or pers ons.

2. RF energy from RF transm itting equipment s uch as portable phones, hand-held radios, wireless
devices, commercial radio and TV, and so on.

3. Conducted interference on powerlines or connected cables caused by other equipm ent, such as
switching power supplies, electrical controls, and natural phenomena such as lightning.

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

Chapter 2. Safety 2 – 17

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

Samsung Medison’s ultrasound products do not generate electromagnetic interference in
excess of standard levels es tablished for such devices.

An Ultrasound System is des igned to receive signals at radio frequency and is therefore
susceptible to interference generated by RF energy sources. Examples of other sources of
interference are medical devices, information technology products, and radio and television
transmission towers. Tracing the source of radiated interference can be a difficult task .
Customers should c onsider the following in an attempt to locate the source:

• Is the interference intermittent or constant?

• Does the interference show up only with one transducer operating at the same frequency or
with several transducers?

• Do two different transducers operating at the same frequency have the same problem?

• Is the interference present if the system is moved to a different location in the facility?

The answers to these questions will help determine if the problem resides with the s ystem or the
scanning environment. After you answer the questions, contact the Samsung Medison
Customer Support Department.

2 – 18 HS40 Service Manual

WARNING

Special caution should be taken during movement.
the product may result in product damage or personal injury.

WARNING

Be aware of the c astors, especially when moving the system. Samsung Medison
recommends that you exercise caution when moving the product up or down
ramps.

2.4. Mechanical Safety

2.4.1. Moving the Equipment

Careless transportation of

• Before transporting the product, check that the brakes on the wheels are unlock ed. Also,
make sure to retract the monitor arm completely so that it is secured in a stationary position.

• Always use the handles on the console and move the product slowly.

This product is designed to resist shocks. However, exces sive shock, for example, if the product
falls over, may cause serious damage.

If the system operates abnormally after repositioning, please c ontact the Samsung Medison
Customer Support Department.

2.4.1.1. Foot Lock

Brakes are mounted to the wheels of the console. To lock the brakes, press the bottom part of
the brake with your foot. To unlock them, press the part labeled OFF at the top of the brake with
your foot.

You can use the brakes to control the movement of the product. We recommend that you lock
the brakes when using the product.

2.4.1.2. Precautions on Ramps

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

Leaving the CART unattended on an inclined surface may cause the CART to topple, even if
you engage the foot lock . Do not rest the product on ramps .

2.4.2. Precautions for Use

•

•

•

•

•

•

•

•

•

the

Do not press the control panel excess ively.

Never attempt to modify the product in any way.

Check the operational safety when using the product after a prolonged break

CAUTION

in service.

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

Do not block the ventilation slots.

Do not pull on the power cord to unplug the product. Doing so might damage

the cord and cause the product to short-circuit, or the cord itself to break.
Unplug the cord by pulling on the plug itself.

Excessive bending or twisting of cables on patient-applied parts may caus e

failure or intermittent operation of the sys tem.

Improper cleaning or sterilization of a patient-applied part may cause

permanent damage.

Servicing the product, including repairs and replacement of parts, must be

done by qualified Samsung Medison service personnel. Assuming that the
product is used in ac cordance with the guidelines contained in this manual
and maintained by qualified service personnel, the expec ted service life of
product is approximately 7 years.

Chapter 2. Safety 2 – 19

Please refer to ‘Chapter 10. Maintenance’ for detailed information on protection, cleaning, and
disinfecting the equipment.

2 – 20 HS40 Service Manual

CAUTION

•

•

2.4.2.1. Caution for Using Monitor

When adjusting the height or position of the monitor, be careful of the space in the middle of the
monitor arm. Catching your fingers or other body parts in it may result in injury.

[Figure 2.2 Safety Note for Monitor]

When moving the product, be sure to keep the monitor arm locked.

When rotating the monitor, be sure to releas e the lock first. Rotating the

monitor while it is locked may cause damage to the internal cables.

Chapter 2. Safety 2 – 21

CAUTION

•

•

•

When you adjust the heigh
track mark) and oil film may be left on the lift. They are the result of the lift's
movements, and not an indication the product is defective.

2.4.2.2. Caution for Using Control Panel

Do not push the control panel with excessive force or lean on it

Do not sit on the control panel or exert ex cessive force on it.

Do not lift the product using the handles on the control panel.

When adjusting the height or position of the control panel, pay attention to the space between
the bottom of the control panel and the lever. Catching your fingers or other body parts in it may
result in injury.

[Figure 2.3 Safety Note for Control Panel]

Pull the height adjustment lever to adjust the height of the control panel.

t of the control panel of this product, a rail mark (or

NOTE

2 – 22 HS40 Service Manual

•
be harmful to the patient. If there is no medical benefit, minimize the exposure

•

•

•

2.5. Biological Safety

For safety instructions concerning probes and biopsies, refer to ‘Chapter 9. Probes’.

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

time and maintain the ultrasound wave output level at low. Please refer to the

WARNING

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 to every circumstance. By keeping
ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize
ultrasonic bioeffects.

ALARA principle.

Do not us e the system if an error mes sage appears on the video display

indicating that a hazardous condition exists. Note the error c ode, turn off the
power to the system, and call Samsung Medison customer service
department.

Do not us e a system that exhibits erratic or inconsistent functioning.

Discontinuities in the scanning sequenc e are indicative of a hardware failure
that should be corrected before use.

The system limits the maximum contact temperature to 43 degrees Celsius,

and the ultrasonic wave output observes American FDA regulations.

Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s
responsibility to control the total energy transmitted into the patient. The sonographer must
reconcile exposure time with diagnos tic image quality. To ensure diagnostic image quality and
limit exposure time, the Ultrasound System provides controls that can be manipulated during the
exam to optimize the results.

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

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

2.5.1.1. Applying ALARA

The sys tem imaging mode us ed depends upon the information needed. 2D mode and M mode
imaging provide anatomical information, while Doppler, Power, and Color imaging provide
information about blood flow. Scanned modes, like 2D mode, Power, or Color, disperse or
scatter the ultrasonic energy over an area, while an unscanned mode, like M mode or Doppler,
concentrate the ultrasonic energy. Understanding the nature of the imaging mode being used
allows the sonographer to apply the ALARA principle with informed judgment. The probe
frequency, system set-up values, scanning techniques , and operator experience aid the

Chapter 2. Safety 2 – 23

sonographer in meeting the ALARA principle. The decision as to the amount of acoustic output
is, in the final analysis, up to the system operator. This decision must be based on the following
factors: type of patient, type of exam, patient history, ease or difficulty of obtaining diagnostically
useful information, and the potential localized heating of the patient due to probe surface
temperatures. Prudent use of the system occurs when patient exposure is limited to the lowest
index reading for the shortest amount of time necessary to achieve acceptable diagnostic
results.

Although a high index reading does not mean that a biological effect is actually oc curring, it
should be tak en seriously. Every effort should be made to reduce the pos sible effects of a high
index reading. Limiting exposure time is an effective way to accomplish this goal.

There are several system controls that the operator can use to adjust the image quality and limit
the acoustic intensity. These controls are related to the techniques that an operator might use to
implement ALARA and can be divided into three categories: direct, indirect, and receiver control.

2.5.1.2. Direct Controls

Application selection and the output intens ity control directly affect acoustic intensity. There are
different ranges of allowable intensity or output depending on your selection. Selecting the
correct range of ac oustic intensity for the applic ation 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 us e.
Samsung Medison systems provide both automatic and user-definable settings.

Output has direct impact on acoustic intensity. Once the applic ation has been es tablished, the
output control can be used to increase or decrease the output intensity. The output c ontrol
allows you to select intensity levels less than the defined maximum. Prudent use dic tates that
you select the lowest output intensity consistent with good image quality.

2.5.1.3. Indirect Controls

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

The choice of imaging mode determines the nature of the ultrasound beam. 2D mode is a
scanning mode, Doppler is a s tationary or unscanned mode. A stationary ultrasound beam
concentrates energy on a single loc ation. A moving or scanned ultrasound beam dis perses the
energy over a wide area and the beam is only c oncentrated on a given area for a fraction of the
time necessary in unscanned mode.

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

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

Pulse length is the time during which the ultrasonic burst is turned on. The longer the pulse, the
greater the time-average intensity value. The greater the time-average intensity, the greater the
likelihood of temperature increase and cavitations. Pulse length, burst length or puls e duration is

2 – 24 HS40 Service Manual

the output pulse duration in Pulsed Doppler. Increasing the Doppler sample volume, increases
the pulse length.

Probe selection affects intensity indirectly. Tissue attenuation changes with frequency. The
higher the probe operating frequency, the greater the attenuation of the ultrasonic energy.
Higher probe operating frequencies require higher output intensity to scan at an increased
depth. To scan deeper at the same output intensity, a lower probe frequency is required. Using
more gain and output beyond a point, without corresponding increases in image quality, can
mean that a lower frequency probe is needed.

■ Receiver Controls

Receiver controls are used by the operator to improve image quality. These c ontrols 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.

2.5.1.4. 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 ex am. A poor exam will
require a follow-up, which ultimately increases the scanning time. Diagnostic ultrasound is an
important tool in medicine, and, like any tool, should be used efficiently and effectively.

2.5.1.5. Output Display Features

The sys tem output display com prises two basic indices: a mecha nical index and a th erm al index.
The thermal index consists of the following indices: soft tissue (TIs), bone (TIb) and cranial bone
(TIc). One of these three thermal indices will be displayed at all times. The thermal index to be
displayed is determined by the system preset or user choice, depending upon the application.

The mechanic al 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 all the
time. Each diagnostic probe application has a default selection. The TIb or TIs is continuously
displayed over its range of 0.0 to maximum output, based on the probe and application, in
increments of 0.1.

The default s etting of the application-spec ific nature is also an important factor of index
selection. A default setting is a system control state which is preset by the manufacturer or the
operator. The sys tem has default index settings for the probe applic ation. The default s ettings
are applied automatically by the ultrasound system when the power is turned on, new patient
data is entered into the system database, or a c hange of 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 s oft tissue, and TIb for a focus at
or near a 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,
may cause the potential for local zone heating to be lower than the thermal index indicates.

The selection of scanne d modes or unscanned mod es o f operation als o 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.

Chapter 2. Safety 2 – 25

Always limit ultrasound exposure time. Do not rush the scanning. Ensure that the indices are
kept to a minimu m, and th at expos ure time is limited without compromising dia gnostic sensitivity.

■ Mechanical Index (MI) Display

Mechanical bioeffects are threshold phenomena that occur when a certain level of output is
exceeded. The threshold level varies, however, with the type of tissue. The potential for
mechanical biologic al 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 bioeffects occurring. However, there is no specific MI value that means that a
mechanical bioeffect will actually occur. The MI should be used as a guide for implementing
the ALARA principle.

■ The rmal Index (TI) Display

The TI informs the user of potential temperature increase occurring on 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 inc rease in specific body tissues . The actual amount of any
temperature rise is influenced by factors such as tissue type, vascularity, and mode of
operation. The TI should be used as a guide for implementing the ALARA principle.

The bone thermal index (TIb) informs the user about potential heating at or near the focus
after the ultrasound beam has passed through soft tissue or fluid, such as the skeletal
structure of a 2-3 month old fetus. The cranial bone thermal index (TIc) informs the user
about the potential heating of bone at or near the surface, for example, the cranial bone. The
soft tissue thermal index (TIs) informs the user about the potential for heating within soft
homogeneous tissue. TIc is displayed when you selec t a trans-cranial application.

You can select the TI to display at Setup > Imaging > Display.

■ Mechanical and Thermal Indices Display Precision and Accuracy

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

The MI and TI display accuracy estimates for the sys tem are given in the manual's Acoustic
Output Tables. These accuracy estimates are based on the variability ranges of probes and
systems, inherent acoustic output modeling errors, and the measurement variability, as
described below.

The display ed values should be interpreted as relative information to help the system
operator achieve the ALARA principle through prudent use of the s ystem. The values should
not be interpreted as actual physical values of investigated tiss ue or organs. The initial data
that is used to support the output display is derived from laboratory measurements bas ed on
the AIUM measurement standard. The measurements are then put into algorithms to
calculate the displayed output values.

Many of the assumptions used in the process of measurement and calculation are
conservative in nature. Over-estimation of actual in situ exposure, for the vast majority of
tiss ue paths, is built into the measurement and calculation process. For example, the
acoustic output values measured underwater are derated us ing 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 tis sue thermal conductivity were s elected.

2 – 26 HS40 Service Manual

A steady state temperature rise is assumed in the industry standard TI models, and the
assumption is made that the ultrasound probe is held steady in one position long enough for
a steady state to be reached.

A number of factors are considered when estimating the ac curacy of display values:
Hardware deviation, algorithm accuracy, and measurement deviation. Deviation among
probes and systems in particular is an important factor. Probe deviation 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 unc ertainties in the
algorithms used for estimating acoustic output values over the range of poss ible system
operating conditions and pulse voltages. Inaccuracies in laboratory meas urements 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 es timation algorithms of linear propagation, at
all depths, through a 0.3dB/cm-MHz attenuated medium are not taken into account in the
calculation of the accuracy estimate displayed. Neither linear propagation nor uniform
attenuation at the 0.3dB/cm-MHz rate occurs in underwater measurements, or in most tissue
paths in the body. In the body, different tissues and organs have dis similar attenuation
characteristics. In water, there is almos t no attenuation. In the body, and particularly in
underwater measurements, non-linear propagation and saturation losses oc cur as pulse
voltages increase.

The display accuracy es timates take into account the variability ranges of probes and
systems, inherent acoustic output modeling errors, and the measurement variability. Display
accuracy estimates are measured according to AIUM measurement standards but not based
on errors caused during the measurement or inherent errors. They are also independent of
the effects of non-linear loss on the measured values.

2.5.1.6. Control Effects – Controls 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 also affect the
on-screen output values.

■ 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.

In combined modes, such as simultaneous Color, 2D mode, and Pulsed Doppler, the total TI
is the sum of TIs of the individual modes. Each mode is a vital c ontributor to this total; the
displayed MI will be from the mode with the largest peak pressure.

2.5.1.7. 2D Mode Controls

■ 2D Mode Size

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

Chapter 2. Safety 2 – 27

■ Zoom

Increasing the zoom magnification may increase frame rate. This will increase the TI. The
number of focal zones may also increase automatically to improve the resolution. This ac tion
may change the MI, sinc e the peak intensity can occur at a different depth.

■ Number of Focal Zones

Increasing the number of focal zones may change both the TI and MI by automatically
changing the frame rate or focal depth. Lower frame rates decrease the TI. The MI displayed
will correspond to the focal zone with the largest peak intens ity.

■ Focus

In general, higher MI values will occur when the focal depth is near the natural focus of the
probe (transducer).

2.5.1.8. Color and Power Controls

■ Color Sensitivity

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

■ Color Sector Width

Narrower color sector width will increase the color frame rate, and so the TI will increase.
The system may automatically decrease the pulse voltage to stay below the system
maximum. A decrease in pulse voltage will decrease the MI. If Pulsed Doppler is also
enabled, th en Pulse d Do ppl er will remai n the d omin ant mode and the TI cha ng e will be small.

■ Color Sector Depth

Deeper color sector depth may automatically decrease color frame rate, or select a new
color focal zone or color pulse length. The TI will change due to the combination of these
effec ts. 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 als o enabled, then Pulsed Doppler will remain the dominant mode and the TI
change will be small.

■ Sca le

Using the Scale control to increase the color veloc ity range may increase the TI. The system
will automatically adjust the pulse voltage to stay below the system maximum. A decrease in
pulse voltage will also decrease MI.

■ 2D Mode Size

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 the dominant mode and the TI change will be small.

2 – 28 HS40 Service Manual

2.5.1.9. M Mode and Doppler Controls

■ Simultaneous and Update Methods

Use o f combi nation mod es affects both th e TI an d MI th ro ugh t he combi nation of pulse types.
During Simultaneous mode, the TI is an ancillary element. During auto-update and duplex,
the TI will display the dominant puls e type. The display ed MI will be from the mode with the
largest peak pressure.

■ Sample Volume Depth

When Doppler sample volume depth is inc reased, the Doppler PRF may automatically
decrease. A decrease in PRF will decrease the TI. The sys tem may also decrease the pulse
voltage to remain below the system maximum. A decrease in pulse voltage will decrease MI.

2.5.1.10. Other

■ 2D, Color, M Mode, PW, and CW Modes

When a new imaging mode is selected, both the TI and the MI will change to their default
settings. Each mode has a corresponding pulse repetition frequency and maximum intensity
point. In combined or simultaneous modes, the TI is the sum of the contribution from the
modes enabled, and the MI is the value for the focal zone of the mode with the largest
derated intensity. If a mode is turned off and then reselected, the system will return to the
previously selected settings.

■ Probe

Each probe model available has unique s pecific ations for the contact area, beam shape, and
center frequency. Defaults are initialized when you select a probe. Samsung Medison’s
factory defaults vary according to the probe, applic ation, and mode. Defaults have been
chosen below the FDA limits for intended use.

■ De pth

An increase in the 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 display ed is that of the zone with
the largest peak intensity.

■ Application

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

Chapter 2. Safety 2 – 29

2.5.1.11. Related Guidance Documents

For more information about ultrasonic bioeffects and related topics, refer to the following;

• Medical Ultrasound Safety (AIUM, 2014).

• AIUM Consensus Report on Potential Bioeffects of Diagnostic Ultrasound: Executive
Summary, J. Ultrasound in Medicine, 2008, Vol. 27, Num. 4.

• W FUMB. Symposium on Safety of Ultrasound in Medicine: Conclusions and
Recommendations on Thermal and Non-thermal Mechanisms for Biological Effects.
Ultrasound in Med. & Biol; 1998, 24: Supplement 1.

• Bioeffects and Safety of Diagnostic Ultrasound (AIUM, 1993)

• Guidelines for the safe use of diagnostic ultrasound equipment. (BMUS, 2009)

• Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers (U.S. FDA - 2008)

• Particular requirements for the basic safety and essential performance of ultrasonic medical
diagnostic and monitoring equipment. (IEC, 2007)

• Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 2008)

• Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment. (IEC, 2007)

• Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices On
Diagnostic Ultrasound Equipment (AIUM/NEMA, 2004)

• Ultrasonics - Field characterization -Test methods for the determination of thermal and
mechanical indices related to medical diagnostic ultrasonic fields (IEC, 2005)

• Measurement and Characterization of Medical Ultrasonic Fields up to 40 MHz. (IEC, 2007)

• Ultrasonics-Power Measurements- Radiation Force Balances and Performance
Requirements. (IEC, 2006)

• Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM/NEMA,

2004).

2 – 30 HS40 Service Manual

)23.0( alf

e

−

)069.0( lf

e

−

2.5.1.12. Acoustic Output and Measurement

Since the first usage of diagnostic ultrasound, the poss ible human biological effects (bioeffects)
of ultrasound exposure have been studied by various scientific and medical institutions. In
October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared
by its Bioeffects Committee (Bioeffect Considerations for the Safety of Diagnostic Ultrasound, J
Ultrasound Med., Sept. 1988: Vol.7, No.9 Supplement), sometimes referred to as the Stowe
Report, which reviewed available data on possible effects of ultrasound exposure. Another
report, “Bioeffects and Safety of Diagnostic Ultrasound”, dated January 28, 1993, provides more
up to date information. In addition, periodically updated reports on biological effects , results, and
guidelines on safe usage have been published by groups s uch as the WFUMB (World
Federation of Ultrasound in Medicine and Biology), AIUM, and BMUS.

The Acoustic output for this system has been measured and calc ulated in accordance with the
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices On
Diagnostic Ultrasound Equipment (AIUM/NEMA, 2004) and Acoustic Output Meas urement
Standard for Diagnostic Ultrasound Equipment (AIUM/NEMA, 2004).

2.5.1.13. 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 the largest possible value. Biological tissue absorbs
acoustic energy. The true value of the intensity at any point depends on t he amount and type of
tiss ue, and the frequency of the ultrasound that passes through the tissue. The intensity value in
the tissue, In Situ, has been estimated using the following formula:

In Situ = Water

Where: In Situ = In Situ Intens ity 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 tis sue, it is diffic ult to estimate the true In Situ intensity. An attenuation factor of 0.3 is
used for general reporting purposes; therefore, the In Situ value is commonly reported using this
formula:

In Situ (derated) = W ater

Since this value is not the true in situ intensity, the term “derated” is used.

Chapter 2. Safety 2 – 31

peak rarefactional acoustic pressure calculated at a specific distance

The maximum derated and max imum water values do not always occur under the same
operating c onditions. Therefore, the reported max imum water and derated values may not be
related to the In Situ (derated) formula. For example, a multi-zone array transducer has the
greatest water value intensities at its deepest zone. The same transducer may have its largest
derated intensity at one of its shallowest focal zones.

2.5.1.14. Terms and Symbols Related to Acoustic Output and Measurement

The terms and symbols used in the acoustic output tables are defined in the following
paragraphs.

-12dB OUTPUT BEAM AREA, ultrasonic beam area induced by -12dB

A

aprt

output beam size (unit: c m

at max. Ipi EQUIVALENT BEAM DIAMETER, the acoustic beam's diameter at the

d

eq

location where the PULSE-INTENSITY INTEGRAL is maximal,
expressed as an equivalent beam area (unit: cm)

EQUIVALENT BEAM DIAMETER, the acoustic beam's diameter at Zb

d

eq(zb)

location, expressed as an equivalent beam area (unit: cm

2

)

2

)

Dim of A

-12dB OUTPUT BEAM DIMENSIONS, the dimensions of an ultrasound

aprt

beam (whose pulse beam width is -12dB) from a specific direction that is
perpendicular to the transducer output plane and the beam alignment
axis (unit: cm)

ACOUSTIC WORKING FREQUENCY, the arithmetic average of f1 and

f

awf

f2 that are farthest from each other among the frequencies of the
pressure spectrum of the acoustic signal whose amplitudes are lower
than the peak amplitude, i.e. maximum amplitude, by 3dB (unit: MHz)

Focal Length The focal length in a direction parallel to the beam alignment axis in the

defined operational state of the ultrasound s ystem (unit: cm)

at max. MI

I

pa,α

(z)

I

ta, α

The average attenuated pulse s trength at the location where Mechanical
Index (MI) is maximal (unit: W/cm

Attenuated average strength over time at a specific focal length (z) (unit:
mW/cm

2

)

2

)

MI MECHANICAL INDEX, a variable representing potential cavitations within

the human body (unit: N/A)

P OUTPUT POWER, the average power over time of an ultrasonic

transducer's emissions into a free field through a specified medium suc h
as water (unit: mW)

(z) ATTENUATED OUTPUT POWER, the power of ultrasonic output

P

α

calculated at a s pecific distance from the transducer after attenuation
occurs (unit: mW)

ATTENUATED PEAK-RAREFACTIONAL ACOUSTIC PRESSURE, the

P

r,α

2 – 32 HS40 Service Manual

after attenuation occurs (unit: MPa)

Pr at max. Ipi The peak rarefactional acoustic press ure at the location where PULSE-

INTENSITY INTEGRAL is maximal (unit: MPa)

prr PULSE REPETITION RATE, the inverse number of the time interval

between two contiguous acoustic pulses (unit: Hz)

TIB BONE THERMAL INDEX, a thermal index for a focal zone formed near a

bone after the ultrasound beam passes through soft tissue, e.g. applied
to a fetus (in the 2nd or 3rd trimester) or to the head of a neonate
(through the fontanel) (unit: N/A)

TIC CRANIAL BONE THERMAL INDEX, a thermal index for an ultrasound

beam entering the body and passing through a bone, e.g. the skull of
children or adults (unit: N/A)

Soft tissue thermal index in scanning mode (unit: N/A)

TIS

scan

TIS

PULSE DURA TION (unit: us)

t

d

z_at_max _Ipi,

DEPTH FOR BONE THERMAL INDEX (unit: cm)

z

b

BREAK-POINT DEPTH, which is the EQUIVALENT APERTURE

z

bp

Soft tis sue thermal index in non-scanning mode (unit: N/A)

non-scan

Location where PULSE-INTENSITY INTEGRAL is maximal (unit: cm)

α

DIAMETER multiplied by 1.5 (unit: cm)

DEPTH FOR SOFT-TISSUE THERMAL INDEX, the distanc e from a

z

s

plane where the product of minimum attenuated output power,
ATTENUATED SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY,
and 1 cm

2

is maximal at the distance range that is equal to, or greater
than, the equivalent aperture diameter multiplied by 1.5, when the beam
dimension of -12dB output is defined along the beam alignment axis (unit:
cm)

Chapter 2. Safety 2 – 33

2.5.1.15. Acoustic Measurement Precision and Uncertainty

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

Qua ntity Precision Total Uncerta i nty

Ipi,α (attenuated pulse intensity integral)

P (acoustic power) 6.2% ±19%

P

(attenuated rarefaction pressure) 5.4% ±15%

r,α

f

(acoustic working frequency) < 1% ±4.5%

awf

3.2% +21% to -24%

■ 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.

– Osc illos cope vertical accuracy.

– Osc illos cope offset accuracy.

– Oscilloscope clock accuracy.

– Osc illos cope Digitization rates.

– Noise.

The acoustic power is measured using a Radiation Force for systematic uncertainties
through the use of calibrated NIST acoustic power sources.

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

1161.

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

– Balance system calibration.

– Absorbing (or reflec ting) 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.

2 – 34 HS40 Service Manual

– Absorbing (reflecting) target geometry and finite target size.

– Target misalignment.

– Ultrasonic transducer mis alignment.

– 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.

2.5.1.16. Training

The users of this ultrasound system must familiarize themselves with the ultrasound system to
optimiz e the performance of the device and to detect possible malfunctions. It is recommended
that all users receive proper training before us ing the device. You can receive training on the
use of the product from the Samsung Medison service department, or any of the customer
support centers worldwide.

Chapter 2. Safety 2 – 35

•

•

•

WARNING

2.6. Protecting the Environment

For dis posal of the system or accessories that have come to the end of their

service lives, contact the vendor or follow appropriate disposal procedures.

You are respons ible for complying with the relevant regulations for disposing

CAUTION

2.6.1. EU WEEE Directive

Thi s marking on the product, acces sories or literature indicates that the product and its
electronic accessories (e.g. charger, headset, USB cable) should not be disposed of with other
household waste at the end of their working life. To prevent possible harm to the environment or
human health from uncontrolled waste disposal, please separate these items from other types
of waste and recycle them responsibly to promote the sustainable reuse of material resources.

of wastes .

The lithium ion battery used in the product must be replaced by a Samsung

Medison service engineer or an authorized dealer.

Correct Disposal of This Product (Waste Electrical & Electronic Equipment)

Household users should contact either the retailer where they purchased this product, or their
local government office, for details of where and how they can take these items for
environmentally safe recycling.

Business users s hould contact their supplier and check the terms and conditions of the
purchase contract. This product and its electronic acc essories should not be mixed with other
commercial wastes for disposal.

2.6.2. EU REACH Regulation

For information on Samsung’s environmental commitments and product specific regulatory
obligations e.g. REACH visit:

Samsung.com/uk/aboutsamsung/samsungelec tronics/corp or atecitiz enship/d ata_corner.html

2.6.3. State of California Proposition 65 Warning (US Only)

This product contains chemicals known to the State of California to cause
cancer, birth defects or other reproductive harm.

Chapter 3

3. Insta lli ng Pr oduct
Chapte r 3 . Insta lling Pr oduct

Installing Product

3.1. Transporting ......................................................................................................... 3

3.1.1. Precautions During Trans po rt ..........................................................................3

3.1.2. Brakes ...........................................................................................................3

3.1.3. Precautions on Ramps ...................................................................................3

3.1.4. Humi dity and Temperatu re ..............................................................................4

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

3.2.1. Dismantlin g the Product's Box .........................................................................5

3.2.2. Accessories ...................................................................................................6

3.2.3. Release of the Locking Mecha nism .................................................................6

3.3. Installation Environment................................................................................... 7

3.3.1. Cauti on..........................................................................................................7

3.4. Installing the Product ........................................................................................ 8

3.4.1. Installatio n Sa fety ...........................................................................................8

3.4.2. Connec ting P erip he rals ................................................................................ 10

3.5. System Power .................................................................................................... 13

3.5.1. Tu rnin g the Power On................................................................................... 13

3.5.2. Shutting Down the System ............................................................................ 13

3.6. System Settings ................................................................................................ 14

3.6.1. General Sy stem Settings .............................................................................. 15

3.6.2. General ....................................................................................................... 15

3.6.3. Display ........................................................................................................ 19

3.6.4. Patient ......................................................................................................... 20

3.6.5. Quick Preset ................................................................................................ 23

3 – 2 HS40 Service Manual

3.6.6. EzExam+..................................................................................................... 24

3.6.7. Imaging ....................................................................................................... 27

3.6.8. Application/Preset ........................................................................................ 30

3.6.9. Application................................................................................................... 32

3.6.10. Measurement Settings.................................................................................. 33

3.6.11. Report ......................................................................................................... 49

3.6.12. Annotatio n ................................................................................................... 52

3.6.13. Body Marker ................................................................................................ 57

3.6.14. Customize ................................................................................................... 60

3.6.15. Peripherals .................................................................................................. 64

3.6.16. Connecti vity ................................................................................................. 67

3.6.17. S e r vic e ........................................................................................................ 86

3.6.18. Help ............................................................................................................ 86

Chapter 3. Installing Product 3 – 3

WARNING

The product weighs more than 100 kg. Be extra careful when transporting it.
Careless transportation of the product may result in product damage or personal
injury.

WARNING

Be especially aware of the castors when moving the system.
Samsung Medison rec
down ramps in advance of any significant reloc ation.

3.1. Transporting

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

3.1.1. Precautions During Transport

This product and its packaging are designed to protect the product from physical impacts.
However, drops and ex ternal impacts may c ause serious damage to the product.

• Before transporting the product, check that the wheel brakes are unlocked.
Also, be sure to retract the monitor arm completely s o that it is secured in a stationary
position.

• Always use the handles at the back of the console and move the product slowly.

3.1.2. Brakes

You can use the brakes to control the movement of the product. The brake pedal is located at
the center of the console pedal and when pressed brakes all the wheels simultaneously. To lock
the brakes, press the front part of the brake pedal with your foot. To unloc k the brakes, press the
back of the pedal.

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

3.1.3. Precautions on Ramps

Always mak e sure that the control panel is facing the direction of movement. If you leave the
product on an incline, the product may fall over even if the brakes are engaged. Do not rest the
product on a ramp.

ommends that you practic e transporting the product up or

3 – 4 HS40 Service Manual

3.1.4. Humidity and Temperature

Table 3-1. The Product's Humidity and Temperature Tolerance shown below illustrates the

appropriate temperature and humidity ranges for transporting, s toring, and operating the
product.

Category Temperature [°C] Humi dity [%]

Transporting -25 – 60 20 – 90

Storage -10 – 50 20 – 90

Operating 10 – 35 30 – 75

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

Chapter 3. Installing Product 3 – 5

3.2. Unpacking the Product

3.2.1. Dismantling the Product's Box

1. Open the box.

2. Remove the protective cover.

3. Take out the probe box and accessory box and store them in a safe place.

4. Unlock the brakes on the wheels.

5. Grab the rear handle on the product and move it to the place where you wish to install it.

[Figure 3.1 Dismantling the Product's Box]

3 – 6 HS40 Service Manual

3.2.2. Accessories

An accessory box containing the items below is supplied with the product. If it does not match
your order, please contact the Samsung Medison cus tomer servic e department or your local
vendor.

3.2.3. Release of the Locking Mechanism

When this product is being transported, the monitor arm must be secured in place by the locking
mechanism to ensure safety. Release the locking mechanis m by following this procedure before
using the product:

1. Pull down the loc king mechanism on the center of the monitor arm to release the lock.

[Figure 3.2 Release of the Locking Mec hanism]

Chapter 3. Installing Product 3 – 7

CAUTION

Placing the system near generators, X
result in screen noise and abnormal visual images.

Sharing the power source with other electrical devices may also produce noise.

3.3. Installation Environment

3.3.1. Caution

When installing the product, please pay attention to the following: For more information on use
and setup, please refer to the accompanying manual for this product.

-ray machines, or broadcast cables may

• Optimal conditions for the sys tem are a temperature of 10-35° and a humidity of 30-75%.

• Avoid ex cess humidity.

• Avoid direct sunlight.

• Avoid excessive fluctuations in temperature.

• Avoid installing the product near a heating appliance.

• Avoid dus ty and/or poorly ventilated locations.

• Avoid locations that are subject to vibration.

• Avoid locations where chemical substances or harmful gases are present.

3 – 8 HS40 Service Manual

NOTE

The product may be shipped with the power cable already connected to the
console.

CAUTION

•

•

3.4. Installing the Product

3.4.1. Installation Safety

The power soc ket and equipotential terminal are located at the back of the product.

[Figure 3.3 Power Socket and Equipotential Terminal]

① Power switch: Supplies power to the entire system or cuts off power Turn off the power.

② Power inlet: Accepts the power cord, which connects to an external power supply.

③ Power fuse: Cuts off the power s upply if overcurrent or overvoltage occurs.

④ Equipotential potential: This should be connected to the equipotential connector in the exam

room.

3.4.1.1. Power Cord Connection

Prior to connecting a power cord, verify that the voltage indicated on the power cord matches
the voltage rating of the installation point.

If the product needs to be transported or stored for an extended period, the

temperature and humidity of the environment must be c hecked.

A sudden change in temperature may cause condensation and lead to

product failure.

Chapter 3. Installing Product 3 – 9

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

Temperature [°C] -20 -15 -10 -5 0 5 10 – 35 45 50 55 60

Waiting time

[Hour]

16 10 8 6 4 2

[Table 3.2 Operational Temperature of the Product]

Use

immediately

2 4 6 10

3.4.1.2. Connecting the Equipotential Terminal

In a hospital environment, dangerous electric currents may occur as a result of the potential
difference between a contactable conductive part and c onnected equipment in treatment rooms.
The solution to the problem is cons istent equipotential bonding. The equipotential terminal of an
item of medical equipment must be connected to the equipotential bonding network in its
treatment room, as shown in the figure below.

3.4.1.3. Probe Connection

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

1. Connect the probes to the probe connectors on the front panel of the sys tem. Up to four (five

including CW ) probes may be connected. The CW probe should only be connected to its
own dedicated connector.

2. To install it, turn the connec tor turning handle clockwise.

[Figure 3.4 Probe Connector]

3 – 10 HS40 Servic e Manual

•

•

NOTE

For more information on the recommended peripheral devices,

3. Installing the Product".

3.4.2. Connecting Peripherals

Do not install peripheral devices within the patient environment that are not

listed in this Service Manual. If you install an unofficial device in the patient
environment, it may cause an electrical hazard.

CAUTION

Do not connect additional external peripheral devic es to the auxiliary socket

outlet. Doing so may increase safety risks.

[Figure 3.5 Patient Environment]

refer to "Chapter

Chapter 3. Installing Product 3 – 11

CAUTION

When using a peripheral device via a
before connecting/disconnecting the device. Connecting or disconnecting a
USB device while the power is turned on may cause the system and/or the
USB device to malfunction.

•

•

3.4.2.1. External Peripheral Devices

These are peripheral devices that can be connec ted for use when needed and are connected
via the USB port located on the rear panel.

USB port, always turn the power off

To remove the removable disk, go to Utility > Storage manager.

USB ports are located both on the console and its rear panel.

We recommend that you connect USB storage devices (flash memory

NOTE

■ USB Vide o Printer

The following products are recommended:

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

• BW: Mits ubishi P-95DE, Sony UP-D897, Sony UP-X898MD, Sony UP-D898MD

[Figure 3.6 B/W Printer Installation Screen]

• Color: Mitsubishi CP-30DW, Sony UP-D25MD

3 – 12 HS40 Servic e Manual

•

•

•

•

•

•

[Figure 3.7 Color Printer Installation Screen]

You must install a printer and driver compatible with the English version of

Microsoft W indows 7. Contact the Samsung Medison cus tomer service
department if you have questions about printer driver installation.

CAUTION

W hen connecting the printer ensure that it is configured under Microsoft

Windows or system setup and has been chosen as the default printer.

Please check which port the printer uses before connecting. Printers should

be connected to the printer port while USB printers should be connected to
the USB port.

■ Other

Flash Memory Media

NOTE

The system cannot recognize USB 1.1 flash memory. Remove the flash

memory from the console and equip again with an appropriate device.

W hen using a flash memory device which supports functions other than

saving files, please check first to see if it is possible to save the file on a
desktop PC.

Do not use flash memory media which contains anti-virus programs or is

defective. Otherwis e, the product may fail to work properly.

Chapter 3. Installing Product 3 – 13

CAUTION

Make sure to connect the probes and peripheral devices that will be used before
powering on the sy stem. If you attempt to connect them during system use, it
may lead to patient injury or irreparable damage to the console.

CAUTION

Before starting the diagnos is, you must register the pati

•

•

•
in Intel PC Main Board of the

•

•

•

•

3.5. System Power

Boot up the sy stem for use.

3.5.1. Turning the Power On

Press the On/Off button when the power is off. Booting begins, and the product logo appears on
the screen. When booting is completed, the 2D mode screen will appear in End Exam status.

ent information.

If the power switc h near the power connection port on the rear panel of the

product has been switc hed off, wait for 10 seconds before turning on the
product.

NOTE

Do not press keyboard keys or buttons while booting is in progress. Doing so

may cause the system to malfunction.

If y ou turn on the power after turning it off suddenly, the sy stem may turn on

and off momentarily. This is a feature of the built­product, and does not indicate a system error.

3.5.2. Shutting Down the System

Press the On/Off button while us ing the s ystem to initiate shutdown. Click Shut Down on the
screen to shut down the system, or click Cancel to cancel.

If the system does not turn off, keep the On/Off button depressed for five

seconds or longer to force a shutdown.

If the ultrasound sys tem is unplugged while working or turned off by forcibly

CAUTION

shutting down, the files may get corrupted and it may result in sys tem failure
or data loss .

To ens ure that the product is safely cut off from electric al power, set the

power switch at the rear of the product to the Off position after using the
product.

Press the On/Off button twice to turn off the s ystem. The Select Next

Operation window appears when you press the On/Off button once. The
system will turn off if you press the button again.

3 – 14 HS40 Servic e Manual

3.6. System Settings

General system settings that do not have direct bearing on imaging are explained. The setup
can be modified depending on your specific needs or preferences.

1. On the touch screen, tap the button, enter the Utility Menu, and tap the Setup button.

2. The Se tup button will appear on the touch s creen. Select a tab that contains items you want
to specify.

TIP

3. Specify the settings for each item.

4. Save settings and exit. Click Ex it on the monitor or tap the Ex i t button on the touch screen
to switch to Scan Mode.

Selecting a Tab

You can select the tab you want in either one of two ways. Select the method
that suits you.

• Use the trackball and the Set button to select a tab.

• Tap the corresponding button on the touch s creen.

[Figure 3.8 Utility, Setup – Touch Screen]

Chapter 3. Installing Product 3 – 15

3.6.1. General System Settings

In the Setup screen, select S y st e m tab. Or tap S yste m on the touch screen.

From this tab, y ou can configure the general system settings .

3.6.2. General

In the Setup screen, select General tab in the Syste m category.

[Figure 3.9 Setup – System – General]

3.6.2.1. Location

You can specify the information that is display ed in the title area on the s creen.

■ Institute

Enter the name of the hospital/institution where the product is ins talled. Special characters
can be entered.

■ Language

Select the system language.
(Supported languages: English, German, French, Spanish, Italian, Russ ian, Simplified
Chinese, Portugues e (Brazilian)

TIP

• For Russian, the Russia Restricted Mode option must be disabled.

• The option must be disabled by qualified Samsung Medison s ervice
personnel.

3 – 16 HS40 Servic e Manual

•

•
installed. If it is not set, the date and time can be automatic ally synchronized

•

•

3.6.2.2. Date and Time

Set the date and time for use in the s ystem.

Before starting diagnosis, please confirm the time, date and time zone and

modify the settings if necessary.

Make s ure to set the date and time to the time z one in which the sy stem is

CAUTION

to the time z one of the country of the manufacturer.

You cannot change the date and time when a patient ID has been

registered. To change the date and time, you should finish the current
diagnosis by pressing the End Ex a m button on the control panel.

NOTE

W hen the system time and date are changed, the change is not reflected in

the time and date indicated in previous diagnosis results.

■ Date Format

Specify the date format. Select a date format using the combo button. The date format that
you specify will be applied to various date fields in Patient Information.

■ Time Format

Specify the time format. Press the combo button to select the preferred display format (12
Hour or 24 Hour).

■ Date and Time

Select settings for date and time. When you press this button, the Date and Time screen
appears.

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

2. Press Save to apply the settings . Tap Cancel or press Exit button on the control panel to
cancel.

■ Time Zone

Specify the local time zone where the system is used. W hen y ou press this button, the Time
Zone Settings screen appears.

1. Press Time Zone.

2. Specify the time z one by using the trackball and the Set button for the combo button.

3. Press OK to apply the settings . Tap Cancel to cancel.

Chapter 3. Installing Product 3 – 17

3.6.2.3. Trackball Speed

■ Scan Mode

Specify the trackball speed in Scanning Mode as Slow, Normal, or Fast.

■ Measurement

Used to specify the track ball’s speed during measurement. Select Slow, Normal, or Fas t.

Slower speeds allow for more precise measurements.

3.6.2.4. Video

■ Format

Choose between NTSC or PAL.

3.6.2.5. Beep Sound

■ Touch Screen

Set the sound level when using the touch screen. Turn it on or off by using the trackball.

■ Control Panel

Set the sound level of sound when using buttons and dial-buttons in the control panel. You
can turn it on or off by using the trackball.

In particular, for Set/Exit, Freeze, Save, and Othe r buttons and dial-buttons, you can turn
them on or off.

3.6.2.6. Account

Register a user ID and password.

■ User Login

Set the user account (login) function. If the user log-in is set to on, it can be used for the
following areas:

– Screen Saver

– Booting up the Sy stem

■ User Account Manage r

This is the exclusive administrator function for approval and management of accounts. The
Account List window will be enabled.

– Create: Fill out the User ID, Password, and Name fields. Then click the OK button to

create a new ID.

– Change Password: Change password.

– Delete: Delete the selected ID.

3 – 18 HS40 Servic e Manual

•

•

•

•

– Close: Close Settings.

[Figure 3.10 Setup – User Account Manager]

■ Login

You can set a User Ac count ID after logging in to the Admin account. Please contact the
service engineer to learn how to reset user acc ount information including the Admin account.

The Admin account c an be configured when you run ‘User Account

Manager’ at Setup for the first time.

The Admin account c annot be deleted.

NOTE

■ Logout

Once the user account function is activated, you cannot load exams without

logging in.

The pas sword must be 8 to 16 characters and composed of at least three of

the following:

– English alphabet upper case

– English alphabet lower cas e

– Numbers

– Special characters

Close the Admin account.

Chapter 3. Installing Product 3 – 19

3.6.3. Display

In the Setup screen, select Display tab in the S yste m category.

Configure the settings for displaying images.

[Figure 3.11 Setup – System – Display]

3.6.3.1. Display

■ System Logo

Choose one of SAMSUNG or HS40.

■ Direction Marker

Set the Direction Marker. Among SAMSUNG HS40, HS40, and S Marker, select a desirable
shape.

■ Screen Saver

Select the wait time (in minutes) for the screen saver. Use the track ball to set it off or 5, 10,
30 or 60 minutes .

■ System Pow er Button

– Ask me what to do: Set a pop-up to appear requesting confirmation before shutting down

the system.

– Shut Down: The power will turn off.

3 – 20 HS40 Servic e Manual

■ Option

– Auto Freeze: Automatic ally switch to freeze state. Set the freeze time between 0 and 60

minutes.

– Prompt for Save on Exit: Use the checkbox to s elect whether to save or not.

– Check On: Set a mess age to recheck whether to save the changes when c losing the

setup.

– Check Off: Set it to automatic ally save changes when closing the setup.

– Boot up Caps Lock On: W hen the checkbox is selected, Caps Lock is turned on after

completing the system booting.

■ Touch Screen Brightness

– By using the trackball, adjust brightness of the touch screen between 0 and 100 in the

units of 10.

– Adjust it by pressing – and + buttons.

3.6.4. Patient

In the Setup screen, select the Patient tab in the S y st e m category.

[Figure 3.12 Setup – System – Patient]

Chapter 3. Installing Product 3 – 21

3.6.4.1. Patient Data

■ Name Display

– Last, First Middle: Dis play the name of the patient in the order last name, first name, then

middle name.

– First Last Middle: Display the name of the patient in the order first name, last name, then

middle name.

■ Title Display

Show or hide patient information in the Title area of the screen.

– None: Patient information is not displayed.

– Date of Birth: Displays the patient’s date of birth.

– Age: Displays the patient’s age.

– Gender: Selec t this checkbox to display the patient’s gender. Note that the patient's

gender can only be displayed if their date of birth or age is also displayed.

■ Title LMP/GA/EDD Display

– LMP/GA: The last menstruation date and estimated gestation weeks are shown on the

screen.

– EDD/GA: The expected delivery date and estimated gestation weeks are shown on the

screen.

■ Middle Name Input Box

When On is checked, a text input field will be display ed enabling you to enter a middle name
when you create a Patient record.

■ Save Patient Page as First Image

If On is checked, Patient information is saved as the first image.

■ Other ID

When a Patient record is created, a GUI for text input is displayed for you to enter the Other
ID.

– Other ID Format: Any, Numbers, Letters and Numbers, and NHS Numbers are available.

Except Any, inputs in each format type can only be entered as text.

3 – 22 HS40 Servic e Manual

3.6.4.2. User Defined List

You may enter information related to studies beforehand, so that you can assign the information
easily when entering patient information. Use the Change, Delete All, Delete, Up, and Dow n
buttons to add, edit, or delete information; y ou may create a list of up to 20 for each item.

• Operator: You can save the name of the operator who scanned the patient.

• Diag. Physician: The name of the phys ician who diagnosed the patient c an be saved.

• Ref. Physician: You can save the name of the referring physician.

• Indication: You can save information about the patient's medical history.

• Description: You can save up to 20 diagnostic memos per application.

Chapter 3. Installing Product 3 – 23

3.6.5. Quick Preset

In the Setup screen, select Quick Pre se t tab in the S yste m category.

[Figure 3.13 Setup – System – Quick Preset]

3.6.5.1. Quick Pre set

After s electing the Probe, Application, and Preset connected to the port, save them to Quick
Preset. Up to 4 sets can be saved. By using Preview, you can preview the saved preset.

• In the diagnosis mode, the saved Probe and Preset are shown as a button on the touch
screen.

3 – 24 HS40 Servic e Manual

3.6.6. EzExam+

In the Setup screen, select the Ez Ex a m+ tab in the S yste m category.

EzExam+ is a macro function that saves your frequently used exams as a protocol and runs
them together. This feature streamlines the diagnosis process.

[Figure 3.14 Setup – System – EzExam+]

3.6.6.1. Protocol List

Protocol List: Provides a protocol list for the application. EzExam+ in the Default List cannot be
deleted or edited and the addition of new EzExam+ is not allowed.

① Category: A list of available applications is shown. If previously configured EzExams are

available, they will be s hown in the Preset Lists when an application is selected. Selection of
ABD, CARD, GYN, MSK, OB, PED, SMP, TCD, URO, or VAS is available.

② New Protocol: W hen New Protocol window appears, enter a name and press OK. Tap

Cancel to cancel.

③ Edit: You can select any protoc ol in the protoc ol list.

④ Rename: You can edit the name of any protocol in the protocol list.

⑤ Delete: Delete a protocol selected from the protocol list.

⑥ Import: Import the protocol data.

⑦ Export: Exports the protocol selected from the protocol list.

⑧ Move Up Button: Moves the protocol selected from the protocol list up one row.

⑨ Move Down Button: Move the protocol selected from the protocol list down one row.