Samsung SONOACE R7 User manual

SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

SONOACE R7

User Manual

Volume 1

SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

Version 3.02

English

SONOACE R7

User Manual

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 4. 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 follows.

VERSION DATE NOTE

v3.02.00-00 2014.12.19

Initial Release

System Upgrades and Manual Set Updates

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.

13

Table of Contents

Table of Contents – Volume 1

Chapter 1 Safety

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

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

Safety Signs ................................................................................................................................. 1-4

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

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

Labels ...................................................................................................................................................................................... 1-6

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

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

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

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

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

EMC........................................................................................................................................................................................1-10

Mechanical Safety .................................................................................................................... 1-17

Moving the Equipment ..................................................................................................................................................1-17

Safety Note .........................................................................................................................................................................1-18

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

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

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

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

Chapter2 Introduction

Specications.............................................................................................................................. 2-3

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

Monitor ................................................................................................................................................................................. 2-9

Control Panel .....................................................................................................................................................................2-11

Console ................................................................................................................................................................................2-16

Peripheral Devices ..........................................................................................................................................................2-18

Probe ..................................................................................................................................................................................... 2-21

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

Optional Functions .......................................................................................................................................................... 2-23

14

User Manual

Chapter3 Starting Diagnosis

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

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

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

Probes & Applications ............................................................................................................... 3-4

Probe Selection and Application ................................................................................................................................. 3-5

Changing Application ...................................................................................................................................................... 3-5

Editing Probe Preset Values ............................................................................................................................................3-5

Patient Information ................................................................................................................... 3-7

Patient Information for Application ............................................................................................................................3-9

Finding Patient Information ......................................................................................................................................... 3-15

Managing Patient Exams...............................................................................................................................................3-17

Changing Measurements .............................................................................................................................................3-23

Chapter4 Diagnosis Modes

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

Diagnosis Mode Type ....................................................................................................................................................... 4-3

Basic Use ................................................................................................................................................................................ 4-4

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

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

Panoramic ..........................................................................................................................................................................4-13

M Mode ................................................................................................................................................................................4-15

Color Doppler Mode .......................................................................................................................................................4-17

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

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

CW Spectral Doppler Mode .........................................................................................................................................4-26

TDI Mode .............................................................................................................................................................................4-27

TDW Mode ..........................................................................................................................................................................4-27

ElastoScan Mode .............................................................................................................................................................4-28

Combined Mode ......................................................................................................................4-36

2D/C/PW Mode .................................................................................................................................................................4-36

2D/PD/PW Mode ..............................................................................................................................................................4-36

2D/C/CW Mode ................................................................................................................................................................. 4-36

2D/PD/CW Mode .............................................................................................................................................................. 4-36

2D/C/M Mode ....................................................................................................................................................................4-37

2D/C Live Mode ................................................................................................................................................................4-37

15

Table of Contents

Multi-Image Mode ................................................................................................................... 4-38

Dual Mode ..........................................................................................................................................................................4-38

Quad Mode .........................................................................................................................................................................4-39

3D/4D Mode .............................................................................................................................. 4-40

3D/4D Mode .......................................................................................................................................................................4-40

3D StandBy Mode ............................................................................................................................................................4-42

3D View-MPR ......................................................................................................................................................................4-45

3D XI Mode (Optional) ...................................................................................................................................................4-61

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 ................................................................................................................. 5-9

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

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

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

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

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

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

OB Calculation ...................................................................................................................................................................5-31

Gynecology Calculation ................................................................................................................................................5-44

Cardiac Calculation .......................................................................................................................................................... 5-51

Carotid Calculation ..........................................................................................................................................................5-63

Urology Calculation.........................................................................................................................................................5-75

Fetal Echo Calculation ....................................................................................................................................................5-80

LE Artery Calculation ......................................................................................................................................................5-85

UE Artery Calculation .....................................................................................................................................................5-95

LE Vein Calculation ....................................................................................................................................................... 5-100

UE Vein Calculation.......................................................................................................................................................5-104

Radiology Calculation ................................................................................................................................................. 5-109

TCD Calculation ............................................................................................................................................................. 5-117

Thyroid Calculation ...................................................................................................................................................... 5-123

Breast Calculation .........................................................................................................................................................5-125

Testicle Calculation ....................................................................................................................................................... 5-127

Supercial Calculation ................................................................................................................................................5-129

Pediatric Hips Calculation .......................................................................................................................................... 5-131

Musculoskeletal Calculation ..................................................................................................................................... 5-133

16

User Manual

Report ......................................................................................................................................5-134

Viewing Report .............................................................................................................................................................. 5-135

Video Out .........................................................................................................................................................................5-136

Editing Report ................................................................................................................................................................ 5-136

Adding Comment ......................................................................................................................................................... 5-138

Printing Report ............................................................................................................................................................... 5-139

Saving Report ................................................................................................................................................................. 5-139

Transferring Report ...................................................................................................................................................... 5-140

Stress Echo Report ........................................................................................................................................................ 5-140

Graph Function .............................................................................................................................................................. 5-141

Closing Report ................................................................................................................................................................ 5-145

** Reference Manual

Samsung Medison is providing an additional SONOACE R7 Reference Manual. GA tables and references for

each application are included in the Reference Manual.

Chapter1





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

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





Safety Signs ......................................................1-4

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

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

Labels ........................................................................................... 1-6





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

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

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

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

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

EMC .............................................................................................1-10





Mechanical Safety ........................................ 1-17

Moving the Equipment .......................................................1-17

Safety Note ...............................................................................1-18





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

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





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

Correct Disposal of This Product

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

Safety

Chapter 1 Safety

1-3

Chapter 1 Safety

Purpose of Use

The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound

imaging and uid analysis of the human body.

The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic,

Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Supercial), Cardiac Adult, Cardiac Pediatric,

Peripheral vessel.

NOTE: For detailed information on applications and presets, please refer to ‘Chapter 2. Introduction’ and

‘Chapter 9. Probes’ in this user manual.

Contraindications

This product must not be used for ophthalmological applications, or any other use that involves the

ultrasound beam passing through the eyeball.

CAUTION:

X

Federal law restricts this device to sale by or on the order of a physician

X

The method of application or use of the device is described in the manual 'Chapter 3. Starting

Diagnosis' and 'Chapter 4. Diagnosis Modes'.

1-4

User Manual

Safety Signs

Please read this chapter before using the Samsung Medison ultrasound system. It is relevant to the

ultrasound system, the probes, the recording devices, and any of the optional equipment.

SONOACE R7 is intended for use by, or by the order of, and under the supervision of, a licensed

physician who is qualied for direct use of the medical device.

Safety Symbols

The International Electrotechnical Commission (IEC) has established a set of symbols for medical electronic

equipment, which classify a connection or warn of potential hazards. The classications and symbols are

shown below.

Symbols Description Symbols Description

WARNING: The accompanying

information must be followed to prevent

serious accidents and/or damage to

property.

Data Input/Output port

CAUTION: The accompanying

information helps to prevent minor

accidents and/or damage to property.

Input port

Refer to the user manual. Output port

Follow the user manual. Print remote output

CAUTION: Risk of electric shock Foot Switch Port

Type BF applied part (Classication

based on degree of protection against

electric hazard)

ECG port

Debrillation-proof type CF applied

part (Classication based on degree of

protection against electric hazard)

USB port

Power on/o Power on

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Samsung SONOACE R7 User manual

Samsung SONOACE R7 User manual

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