Samsung SONOACE R7 User manual

Operation Manual

Version 1.02.00

English

Diagnostic Ultrasound System

M355-E10200-00

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:

▶

Type of protection against electrical shock: Class I

▶

Degree of protection against electrical shock (Patient connection): Type BF equipment

▶

Degree of protection against harmful ingress of water: Ordinary equipment

▶

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.

▶

Mode of operation: Continuous operation

■

Electromechanical safety standards met:

▶

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

[IEC 60601-1:2005]

▶

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 60601-1-6:2006]

▶

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

Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC60601-2-37:2007]

▶

Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with A1:1991

and A2:1995]

▶

Medical Electrical Equipment, Part 1: General Requirements for Safety – 1 Collateral Standard: safety

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

▶

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

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

▶

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

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

▶

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

Diagnostic and Monitoring Equipment [IEC60601-2-37: 2001 with 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 [UL60601-1:2003]

▶

Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA 22.2

No.601.1-M90:1990, with R2003, with R2005]

▶

Biological Evaluation of Medical Devices [ISO10993 : 2009]

▶

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

[IEC61157:2007]

■

Declarations:

This is CSA symbol for Canada and United States of America

This is manufacturer’s declaration of product compliance with

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

This is manufacturer’s declaration of product compliance with

applicable EEC directive(s).

Read This First

How to Use Your Manual

This manual addresses the reader who is familiar with ultrasound techniques. Only medical doctors

or persons supervised by medical doctors should use this system. Sonography training and clinical

procedures are not included here. This manual is not intended to be used as training material for the

principles of ultrasound, anatomy, scanning techniques, or applications. You should be familiar with all of

these areas before attempting to use this manual or your ultrasound system.

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

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

It is useless to make constant or complex adjustments to the equipment controls. The system has been

preset at the factory to produce an optimum image in the majority of patients. User adjustments are not

usually required. If the user wishes to change image settings, the variables may be set as desired. Optimal

images are obtained with little diculty.

We are not responsible for errors that occur when the system is run on a user’s PC.

Non-SAMSUNG MEDISON product names may be trademarks of their respective owners.

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 ‘Chapter1. Safety’ and ‘Chapter8. Maintenance’ in this manual,

prior to starting to use this system.

NOTE:

Some features are not available in some countries. The features with options, and specifications

that this manual present can be changed without notice. Government approval is still pending in some

nations.

Conventions Used in This Manual

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.

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.

Revision History

DOCUMENT DATE REASON FOR CHANGE

M355-E10200-00 2011-05-31 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.

9

Table of Contents

Chapter 1 Safety

Indication for Use ....................................................................................................................... 1-3

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

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

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

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

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

Electrical Safety .......................................................................................................................... 1-8

Prevention of Electric Shock .......................................................................................................................................... 1-8

ECG-Related Information ..............................................................................................................................................1-10

ESD .........................................................................................................................................................................................1-10

EMI .........................................................................................................................................................................................1-11

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

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

Moving the Equipment ..................................................................................................................................................1-18

Safety Note .........................................................................................................................................................................1-19

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

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

Environmental Protection ......................................................................................................1-33

Waste Electrical and Electronic Equipment .........................................................................................................1-33

Chapter2 Introduction

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

Product Conguration and Installation ................................................................................ 2-5

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

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

Console ................................................................................................................................................................................2-15

Peripheral Devices ..........................................................................................................................................................2-17

Probe ..................................................................................................................................................................................... 2-19

Accessories .........................................................................................................................................................................2-20

Optional Functions .......................................................................................................................................................... 2-20

10

Operation 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 .............................................................................................................................................3-22

Chapter4 Diagnosis Modes

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

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

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

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

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

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

Color Doppler Mode .......................................................................................................................................................4-15

Power Doppler Mode .....................................................................................................................................................4-18

PW Spectral Doppler Mode ..........................................................................................................................................4-20

CW Spectral Doppler Mode .........................................................................................................................................4-25

TDI Mode .............................................................................................................................................................................4-26

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

Combined Mode ......................................................................................................................4-28

2D/C/PW Mode .................................................................................................................................................................4-28

2D/PD/PW Mode ..............................................................................................................................................................4-28

2D/C/CW Mode ................................................................................................................................................................. 4-28

2D/PD/CW Mode .............................................................................................................................................................. 4-28

2D/C/M Mode ....................................................................................................................................................................4-29

2D/C Live Mode ................................................................................................................................................................4-29

11

Table of Contents

Multi-Image Mode ................................................................................................................... 4-30

Dual Mode ..........................................................................................................................................................................4-30

3D / 4D Mode ............................................................................................................................ 4-31

3D/4D Mode .......................................................................................................................................................................4-31

3D StandBy Mode ............................................................................................................................................................4-33

3D View-MPR ......................................................................................................................................................................4-36

3D XI Mode (Optional) ...................................................................................................................................................4-52

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 ..................................................................................................................5-15

Volume Measurement .................................................................................................................................................... 5-17

Calculations by Application ................................................................................................... 5-20

Things to note ...................................................................................................................................................................5-20

Common Measurement Methods .............................................................................................................................5-23

OB Calculation ...................................................................................................................................................................5-27

Gynecology Calculation ................................................................................................................................................5-36

Cardiac Calculation .......................................................................................................................................................... 5-40

Carotid Calculation ..........................................................................................................................................................5-49

Urology Calculation.........................................................................................................................................................5-58

Fetal Echo Calculation ....................................................................................................................................................5-62

LE Artery Calculation ......................................................................................................................................................5-66

UE Artery

Calculation ......................................................................................................................................................5-72

LE Vein Calculation ..........................................................................................................................................................5-75

UE Vein Calculation..........................................................................................................................................................5-78

Radiology Calculation ....................................................................................................................................................5-82

TCD Calculation ................................................................................................................................................................5-86

Thyroid Calculation .........................................................................................................................................................5-89

Breast Calculation ............................................................................................................................................................5-90

Testicle Calculation ..........................................................................................................................................................5-92

Supercial Calculation ...................................................................................................................................................5-93

Pediatric Hips Calculation .............................................................................................................................................5-94

Musculoskeletal Calculation ........................................................................................................................................5-96

12

Operation Manual

Report ........................................................................................................................... 5-97

Viewing Report .................................................................................................................................................................5-97

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

Adding Comment ......................................................................................................................................................... 5-100

Printing Report ............................................................................................................................................................... 5-100

Saving Report ................................................................................................................................................................. 5-101

Transferring Report ...................................................................................................................................................... 5-101

Graph Function .............................................................................................................................................................. 5-102

Closing Report ................................................................................................................................................................5-106

Chapter6 Image Management

Reviewing Images (CINE / LOOP) ............................................................................................ 6-3

Annotating Images ................................................................................................................... 6-6

Text .......................................................................................................................................................................................... 6-6

Body Marker ........................................................................................................................................................................ 6-9

Indicator .............................................................................................................................................................................6-11

Saving, Playing and Transferring Images ............................................................................ 6-13

Saving Images ..................................................................................................................................................................6-13

Playing Images ..................................................................................................................................................................6-15

Transferring Images .......................................................................................................................................................6-16

Printing and Recording Images ........................................................................................... 6-17

Printing Images .................................................................................................................................................................6-17

Recording Images ...........................................................................................................................................................6-17

SONOVIEW ................................................................................................................................ 6-18

Exam Mode ......................................................................................................................................................................... 6-18

Compare Mode .................................................................................................................................................................6-20

Managing Exam Images ................................................................................................................................................6-22

13

Table of Contents

Chapter7 Utilities

System Settings .......................................................................................................................... 7-3

General System Settings .................................................................................................................................................7-3

Display Settings .................................................................................................................................................................. 7-7

Peripherals Setup .............................................................................................................................................................7-10

System Information ........................................................................................................................................................7-13

DICOM Setup (Optional) ................................................................................................................................................7-14

Utilities Setup ....................................................................................................................................................................7-29

Option Setup .....................................................................................................................................................................7-33

Auto Calc .............................................................................................................................................................................7-35

Measurement Setup ................................................................................................................7-36

General Measurement Setup ......................................................................................................................................7-37

Obstetrics Measurement Setup ..................................................................................................................................7-50

Cardiac Measurement Setup .......................................................................................................................................7-58

Vascular Measurement Setup .....................................................................................................................................7-59

Urology Measurement Setup ......................................................................................................................................7-60

Fetal Echo Measurement Setup..................................................................................................................................7-62

Utility .......................................................................................................................................... 7-63

ECG ........................................................................................................................................................................................7-65

Biopsy ...................................................................................................................................................................................7-67

Histogram ...........................................................................................................................................................................7-69

Post Curve ...........................................................................................................................................................................7-71

Setup ..................................................................................................................................................................................... 7-76

Measure Setup ..................................................................................................................................................................7-76

Storage Manager ..............................................................................................................................................................7-77

Bodymarker Edit ...............................................................................................................................................................7-79

Menu Edit ............................................................................................................................................................................7-81

14

Operation Manual

Chapter8 Maintenance

System Maintenance ................................................................................................................. 8-3

Installation Requirements............................................................................................................................................... 8-3

Cleaning and disinfections ............................................................................................................................................ 8-4

Fuse Replacement ............................................................................................................................................................. 8-6

Cleaning The Air Filters .................................................................................................................................................... 8-7

Accuracy Check ................................................................................................................................................................... 8-8

Administration of Information ................................................................................................ 8-9

User Setting Back up ......................................................................................................................................................... 8-9

Patient information Back-up ..........................................................................................................................................8-9

Software................................................................................................................................................................................. 8-9

Chapter9 Probes

Probes .......................................................................................................................................... 9-3

Ultrasound transmission Gel ......................................................................................................................................... 9-9

Sheaths.................................................................................................................................................................................9-10

Probe Precautions ............................................................................................................................................................9-11

Cleaning and Disinfecting the Probe .......................................................................................................................9-13

Biopsy .........................................................................................................................................9-20

Biopsy KIT Components ................................................................................................................................................9-20

Using the Biopsy Kit ........................................................................................................................................................9-21

Cleaning and Disinfecting Biopsy Kit .......................................................................................................................9-23

Assembling the Biopsy Kit ............................................................................................................................................9-25

** 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





Indication for Use ............................................1-3

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





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

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

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

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





Electrical Safety ...............................................1-8

Prevention of Electric Shock ................................................ 1-8

ECG-Related Information ....................................................1-10

ESD ..............................................................................................1-10

EMI ...............................................................................................1-11

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





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

Moving the Equipment .......................................................1-18

Safety Note ...............................................................................1-19





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

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





Environmental Protection ........................... 1-33

Waste Electrical and Electronic Equipment .................1-33

Safety

Chapter 1 Safety

1-3

Chapter 1 Safety

Indication for 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, Superficial), Cardiac Adult, Cardiac Pediatric,

Peripheral vessel.

Contraindications

The SONOACE R7 system is not intended for ophthalmic use or any use causing the acoustic beam to pass

through the eye.

CAUTION:

▶

Federal law restricts this device 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 3. Starting

Diagnosis' and 'Chapter 4. Diagnosis Modes'.

1-4

Operation 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 Electro Technical Commission (IEC) has established a set of symbols for medical electronic

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

shown below.

Symbols Description Symbols Description

AC (alternating current) voltage

source

Data Output port

Indicates a caution for risk of electric

shock.

Data Input port

Isolated patient connection (Type BF

applied part).

Data Input/Output port

Power switch (Supplies/cuts power to

the product)

Left and right Audio / Video output

On / O button (Partially cuts power

to the product)

Remote print output

Identies an equipotential ground. Foot switch port

Indicates dangerous voltages of over

1000V AC or over 1500V DC.

ECG port

Identies the point where the system

safety ground is fastened to the

chassis. Protective earth connected to

conductive parts of Class I equipment

for safety purposes.

USB port

1-5

Chapter 1 Safety

Symbols Description Symbols Description

Network port Probe port

MIC port ESD warning

Protection against the eects of

immersion.

CAUTION

Protection against dripping water. Consult Instructions for Use

Do not sit on control panel Do not push the product

Do not lean against the product Follow the operation manual

Symbols

Symbols Description Symbols Description

Authorised Representative In The

European Community

Manufacture :

SAMSUNG MEDISON CO., LTD.

1-6

Operation Manual

Labels

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

[Label 1. Marked on the back sides of the product]

[Label 2. Marked below OUTLET]

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Samsung SONOACE R7 User manual

Samsung SONOACE R7 User manual

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