Samsung MYSONO U6 User manual

SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

MySono U6

User Manual

Volume 1

SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

Version 1.02

English

MySono U6

User Manual

PROPRIETRAY INFORMATION AND SOFTWARE LICENSE

The Customer shall keep condential all proprietary information furnished or disclosed to the Customer

by Samsung Medison, unless such information has become part of the public domain through no fault of

the Customer. The Customer shall not use such proprietary information, without the prior written consent

of Samsung Medison, for any purpose other than the maintenance, repair or operation of the goods.

Samsung Medison’s systems contain Samsung Medison’s proprietary software in machine-readable

form. Samsung Medison retains all its rights, title and interest in the software except that purchase of this

product includes a license to use the machine-readable software contained in it. The Customer shall not

copy, trace, disassemble or modify the software. Transfer of this product by the Customer shall constitute

a transfer of this license that shall not be otherwise transferable. Upon cancellation or termination of this

contract or return of the goods for reasons other than repair or modication, the Customer shall return to

Samsung Medison all such proprietary information.

Safety Requirements

 Classications:

X

Type of protection against electrical shock: Class I

X

Degree of protection against electrical shock (Patient connection): Type BF or CF Applied Part

X

Degree of protection against harmful ingress of water: Ordinary equipment

X

Degree of safety of application in the presence of a ammable anesthetic material with air or

with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a ammable

anesthetic mixture with air or with oxygen or nitrous oxide.

X

Mode of operation: Continuous operation

 Electromechanical safety standards met:

X Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential

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

X 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]

X Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential

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

X Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential

Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37:2007]

X Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with

A1:1991 and A2:1995]

X Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral Standard: Safety

Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]

X Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:

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

X Medical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral Standard:

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

X Medical Electrical Equipment, Part 2-37: Particular Requirements for Safety - Ultrasonic Medical

Diagnostic and Monitoring Equipment [IEC 60601-2-37:2001 with A1:2004, A2:2005]

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

X Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-1:2003]

X Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance

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

X 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]

X Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management

process [ISO 10993-1:2009]

X Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment

[IEC 61157:2007]



Declarations

CSA mark with the indicators “C” and “US” means that the product is certied for

both the U.S. and Canadian markets, to the applicable U.S. and Canadian standards.

This is the manufacturer’s declaration of product compliance with applicable EEC

directive(s) and the European notied body.

This is the manufacturer’s declaration of product compliance with applicable EEC

directive(s).

This is the GMP symbol for Korean Good Manufacturing Practice quality system

regulation.

Precautions for Use

You should be familiar with all of these areas before attempting to use this manual or your ultrasound

system.

 Please keep this user guide close to the product as a reference when using the system.

 For safe use of this product, you should read ‘Chapter 1. Safety’ and ‘Chapter 8. Maintenance’ in this

manual, prior to starting to use this system.

 This manual does not include diagnosis results or opinions. Also, check the measurement reference for

each application’s result measurement before making the nal diagnosis.

 This product is an ultrasound scanner and cannot be used from a user’s PC. We are not responsible for

errors that occur when the system software is run on a user’s PC.

 Only medical doctors or persons supervised by medical doctors should use this system. Persons who

are not qualied must not operate this product.

 The manufacturer is not responsible for any damage to this product caused by carelessness and/or

neglect by the user.

 Please note that orders are based on the individually agreed specications and may not contain all

features listed in the user manual.

 It might be possible that some features, options or probes are NOT available in some countries.

 All references to standards / regulations and their revisions are valid for the time of publication of the

user manual.

 The gures in the user manual for illustrational purposes only and may be dierent from what you see

on the screen or device.

 Information contained in this operating manual is subject to change without prior notice.

 Products that are not manufactured by Samsung Medison are marked with the trademark of their

respective copyright holders.

 The headings below describe vitally important precautions necessary to prevent hazards.

DANGER: Describes precautions necessary to prevent user hazards of great urgency. Ignoring a

DANGER warning will risk life-threatening injury.

WARNING: Used to indicate the presence of a hazard that can cause serious personal injury, or

substantial property damage.

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

NOTE: A piece of information useful for installing, operating and maintaining a system. Not

related to any hazard.

Revision History

The revision history of this manual is as the follows.

VERSION DATE NOTE

v1.02.00-00 2014.12.19

Initial Release

Product Upgrade and Manual Update

Samsung Medison Ultrasound is committed to innovation and continued improvement. Upgrades may be

announced that consist of hardware or software improvements. Updated manuals will accompany those

system upgrades.

Verify that Check if this version of the manual is correct for the system version. If not, please contact the

Customer Service Department.

If You Need Assistance

If you need any assistance with the equipment, like the service manual, please contact the Samsung Medison

Customer Service Department or one of their worldwide customer service representatives, immediately.

15

Table of Contents

Table of Contents – Volume 1

Chapter 1 Safety

Purpose of Use ............................................................................................................................ 1-3

Contraindications .............................................................................................................................................................. 1-3

Safety Information ..................................................................................................................... 1-4

Safety Symbols ....................................................................................................................................................................1-4

Symbols .................................................................................................................................................................................1-5

LABEL ......................................................................................................................................................................................1-6

Electrical Safety .......................................................................................................................... 1-7

Prevention of Electric Shock .......................................................................................................................................... 1-7

ECG-Related Information ................................................................................................................................................ 1-9

ESD ...........................................................................................................................................................................................1-9

EMI .........................................................................................................................................................................................1-10

EMC ......................................................................................................................................................................................1-11

Mechanical Safety .................................................................................................................... 1-18

Safety Notes .......................................................................................................................................................................1-18

Moving the Equipment ..................................................................................................................................................1-19

Biological Safety ......................................................................................................................1-20

ALARA Principle ................................................................................................................................................................1-20

Environmental Protection ...................................................................................................... 1-34

Correct Disposal of This Product (Waste Electrical & Electronic Equipment) ............................................1-34

Battery Pack ..............................................................................................................................1-35

Correct disposal of batteries in this product .........................................................................................................1-36

Chapter 2 Introduction

Specication ............................................................................................................................... 2-3

Product Conguration ............................................................................................................. 2-6

Monitor ..................................................................................................................................................................................2-7

Control Panel ....................................................................................................................................................................... 2-9

Console ...............................................................................................................................................................................2-14

Peripheral Devices ...........................................................................................................................................................2-16

16

User Manual

Battery Pack ........................................................................................................................................................................2-18

Probes ................................................................................................................................................................................... 2-20

MySono U6 Cart (sold separately) .............................................................................................................................2-21

Accessories .........................................................................................................................................................................2-22

Optional Functions .......................................................................................................................................................... 2-22

Chapter 3 Starting Diagnosis

Power Supply .............................................................................................................................. 3-3

AC Adapter Connection ................................................................................................................................................... 3-3

Powering On ....................................................................................................................................................................... 3-4

Powering O ........................................................................................................................................................................ 3-4

Monitor and Audio ................................................................................................................... 3-5

Monitor Brightness Adjustment ...................................................................................................................................3-5

Volume Adjustment .......................................................................................................................................................... 3-5

Probes & Applications .............................................................................................................. 3-6

Probe Connection .............................................................................................................................................................. 3-7

Application Selection ....................................................................................................................................................... 3-8

Changing Probe Preset .................................................................................................................................................... 3-8

Patient Information .................................................................................................................. 3-9

Basic Patient Information Entry .................................................................................................................................... 3-9

Application-Specic Patient Information ...............................................................................................................3-11

Searching for Patient Information .............................................................................................................................3-20

Managing Patient Exams...............................................................................................................................................3-23

Changing Measurements .............................................................................................................................................3-30

Power Saving Mode ................................................................................................................3-33

Chapter 4 Diagnosis Modes

Information ................................................................................................................................. 4-3

Types of Diagnosis Modes .............................................................................................................................................. 4-3

Basic Operating Instructions ........................................................................................................................................ 4-4

Basic Mode .................................................................................................................................. 4-6

2D Mode ................................................................................................................................................................................ 4-6

M Mode ...............................................................................................................................................................................4-13

Color Doppler Mode ......................................................................................................................................................4-16

Power Doppler Mode ....................................................................................................................................................4-20

17

Table of Contents

PW Spectral Doppler Mode .........................................................................................................................................4-22

CW Spectral Doppler Mode ........................................................................................................................................4-28

TDI Mode .............................................................................................................................................................................4-30

TDW Mode .........................................................................................................................................................................4-31

Combined Mode ......................................................................................................................4-33

2D/C/PW Mode .................................................................................................................................................................4-33

2D/PD/PW Mode ..............................................................................................................................................................4-33

2D/C/CW Mode ................................................................................................................................................................. 4-33

2D/PD/CW Mode .............................................................................................................................................................. 4-33

2D/C/M Mode ...................................................................................................................................................................4-34

2D/C Live Mode ................................................................................................................................................................4-34

Dual Mode ................................................................................................................................. 4-35

3D/4D Mode .............................................................................................................................. 4-36

3D Stand by ........................................................................................................................................................................4-37

3D View-MPR ......................................................................................................................................................................4-40

3D XI ......................................................................................................................................................................................4-56

Chapter 5 Measurements and Calculations

Measurement Accuracy ............................................................................................................ 5-3

Causes of Measurement Errors .....................................................................................................................................5-3

Optimization of Measurement Accuracy .................................................................................................................. 5-5

Measurement Accuracy Table ....................................................................................................................................... 5-7

Basic Measurements ................................................................................................................. 5-8

Distance Measurement ..................................................................................................................................................5-11

Measurement of Circumference and Area .............................................................................................................5-16

Volume Measurement ....................................................................................................................................................5-18

Calculations by Application ..................................................................................................5-21

Things to note .................................................................................................................................................................5-21

Common Measurement Methods ............................................................................................................................5-25

OB Calculations .................................................................................................................................................................5-30

Gynecology Calculations .............................................................................................................................................5-40

Cardiac Calculations ........................................................................................................................................................ 5-43

Carotid Calculations ........................................................................................................................................................5-61

LE Artery Calculations ....................................................................................................................................................5-67

UE Artery Calculations ...................................................................................................................................................5-69

LE Vein Calculation .........................................................................................................................................................5-71

18

User Manual

UE Vein Calculations ........................................................................................................................................................ 5-73

Fetal Echo Calculations ..................................................................................................................................................5-75

Urology Calculations .......................................................................................................................................................5-80

Abdomen Calculations .................................................................................................................................................5-84

Small Parts Calculations ................................................................................................................................................5-88

TCD Calculations .............................................................................................................................................................5-93

Musculoskeletal Calculations ......................................................................................................................................5-95

Pediatric Hips Calculations ...........................................................................................................................................5-96

Report ........................................................................................................................................5-98

Viewing Reports ..............................................................................................................................................................5-98

Editing Reports .............................................................................................................................................................. 5-100

Adding Comments ....................................................................................................................................................... 5-102

Printing Reports ............................................................................................................................................................. 5-102

Exporting Reports ......................................................................................................................................................... 5-103

Transferring Reports .................................................................................................................................................... 5-104

Graph screen ...................................................................................................................................................................5-104

Closing Reports ..............................................................................................................................................................5-108

Reference Manual

Samsung Medison provides an additional MySono U6 Reference Manual (English).





Purpose of Use ..................................................1-3

Contraindications ...................................................................1-3





Safety Information ..........................................1-4

Safety Symbols .........................................................................1-4

Symbols .......................................................................................1-5

LABEL ...........................................................................................1-6





Electrical Safety ................................................1-7

Prevention of Electric Shock ................................................1-7

ECG-Related Information ......................................................1-9

ESD ................................................................................................ 1-9

EMI ...............................................................................................1-10

EMC ............................................................................................1-11





Mechanical Safety ........................................ 1-18

Safety Notes .............................................................................1-18

Moving the Equipment .......................................................1-19





Biological Safety ........................................... 1-20

ALARA Principle .....................................................................1-20





Environmental Protection ........................... 1-34

Correct Disposal of This Product

(Waste Electrical & Electronic Equipment)...................1-34





Battery Pack .................................................. 1-35

Correct disposal of batteries in this product ...............1-36

Chapter 1

Safety

Chapter 1 Safety

Page is loading ...

Samsung MYSONO U6 User manual

Related papers

Other documents