Samsung PT60A User manual

SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

PT60A

User Manual

SAMSUNG MEDISON

DIAGNOSTIC ULTRASOUND SYSTEM

Version 1.01

English

PT60A

User Manual

PROPRIETRAY INFORMATION AND SOFTWARE LICENSE

The Customer shall keep confidential 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 modification, the Customer shall return to

Samsung Medison all such proprietary information.

Safety Requirements

 Classifications:

X

Type of protection against electrical shock: Class I

X

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

X

Degree of protection against harmful ingress of water: Ordinary equipment

X

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

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

anesthetic mixture with air or with oxygen or nitrous oxide.

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 Safety [CAN/CSA C22.2 No. 601.1-

M90: 1990, with R2003, with R2005]

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 certified

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

standards.

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

directive(s) and the European notified 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

Be sure to read this manual thoroughly to familiarize yourself with the operation of the product and the

relevant safety information before attempting to use the product.

 Keep this manual near the product and refer to it when using the product.

 Please familiarize yourself with the safety precautions in 'Chapter 1. Safety' and 'Chapter 8. Maintenance

in particular.

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

measured area of the body before using the application’s measurement results in any diagnosis.

 This product is an ultrasound diagnosis device and cannot be used with your PC. The manufacturer is not

responsible for any problems that may be caused by such attempts.

 This product must only be used by persons who are trained and/or certified to operate clinical diagnostic

devices. Unqualified persons must not use this product.

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

neglect.

 Please note that orders are based on the individually agreed specifications 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 figures in the User Manual for illustrational purposes only and may be different from what you see

on the screen or device.

 The contents and specifications described in this manual may be changed without notice.

 Products that are not manufactured by Samsung Medison are indicated with the trademarks of their

respective owners.

 The following terms are used to highlight safety precautions that the user must be aware of:

DANGER: Disregarding this instruction may result in death, serious injury, or other dangerous

situations.

WARNING: Follow these instructions to prevent a serious accident or damage to property.

CAUTION: Follow these instructions to prevent a minor accident or damage to property.

NOTE: The accompanying information covers an installation, operation, or maintenance

procedure that requires careful attention from the user, but has little chance of leading directly to

a dangerous situation.

Revision History

The revision history of this manual is as follows.

VERSION DATE NOTE

v1.01.02-00 2014.12.15 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.

13

Table of Contents

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 Shocks ........................................................................................................................................ 1-7

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

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

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

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

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

Safety Notes .......................................................................................................................................................................1-17

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

Biological Safety ......................................................................................................................1-18

ALARA Principle ................................................................................................................................................................1-18

Protecting the Environment ..................................................................................................1-33

Correct Disposal of This Product

(Waste Electrical & Electronic Equipment) .............................................................................................................1-33

Battery Pack ..............................................................................................................................1-34

Correct Disposal of Batteries in This Product ........................................................................................................1-35

Chapter 2 Introduction

Product Specifications .............................................................................................................. 2-3

Product Configuration .............................................................................................................. 2-5

Monitor .................................................................................................................................................................................. 2-6

Console .................................................................................................................................................................................2-9

Peripheral Devices ...........................................................................................................................................................2-11

Video Out ............................................................................................................................................................................2-13

14

User Manual

Battery Pack ........................................................................................................................................................................2-15

Probes ................................................................................................................................................................................... 2-17

PT60A CART (Optional) ..................................................................................................................................................2-18

Accessories .........................................................................................................................................................................2-19

CRADLE ................................................................................................................................................................................2-20

Optional Functions .......................................................................................................................................................... 2-21

Chapter 3 Starting Diagnosis

System Power ............................................................................................................................. 3-3

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

Turning the Power On ..................................................................................................................................................... 3-4

Shutting Down the System ............................................................................................................................................ 3-4

Probes and Presets .................................................................................................................... 3-5

Selecting Probe and Preset ............................................................................................................................................ 3-6

Managing Presets .............................................................................................................................................................. 3-6

Patient Information .................................................................................................................. 3-8

Patient Information for Each Application ...............................................................................................................3-11

Searching Patient Information ....................................................................................................................................3-16

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

Biopsy Guide ......................................................................................................................................................................4-11

Needle Mate .......................................................................................................................................................................4-12

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

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

Power Doppler Mode .....................................................................................................................................................4-19

PW Spectral Doppler Mode .........................................................................................................................................4-21

Combined Mode ......................................................................................................................4-24

2D/C/PW Mode .................................................................................................................................................................4-24

2D/PD/PW Mode ..............................................................................................................................................................4-24

Multi-Image Mode ................................................................................................................... 4-25

Dual Mode ..........................................................................................................................................................................4-25

15

Table of Contents

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 ..................................................................................................................................................5-10

Circumference and Area measurement ..................................................................................................................5-17

Volume measurement ....................................................................................................................................................5-19

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

Things to Note ...................................................................................................................................................................5-20

Common Measurement Methods .............................................................................................................................5-22

OB Calculations .................................................................................................................................................................5-24

Gynecology Calculations .............................................................................................................................................5-27

Vascular Calculations ......................................................................................................................................................5-29

Echocardiographic Measurement (Cardiac Calculations) ................................................................................5-31

Report ........................................................................................................................................5-32

Viewing Reports ..............................................................................................................................................................5-32

Adding Comments ..........................................................................................................................................................5-34

Store SR ................................................................................................................................................................................5-34

Printing Reports ................................................................................................................................................................ 5-35

Closing Reports ................................................................................................................................................................. 5-35

Chapter 6 Image Management

Cine / Loop .................................................................................................................................. 6-3

Annotating Images .................................................................................................................... 6-5

Annotation ........................................................................................................................................................................... 6-5

BodyMarker .......................................................................................................................................................................... 6-9

Exiting Annotation ..........................................................................................................................................................6-10

Saving, Playing and Transferring Images ............................................................................6-11

Saving Images ...................................................................................................................................................................6-11

Transferring Images ........................................................................................................................................................6-12

SonoView Mode .......................................................................................................................6-13

Exam Mode ......................................................................................................................................................................... 6-15

16

User Manual

Chapter 7 Utilities

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

General System Settings .................................................................................................................................................7-4

Patient .................................................................................................................................................................................... 7-6

Screen Display Settings (Imaging)............................................................................................................................... 7-7

Annotation Settings .......................................................................................................................................................... 7-9

Measurement Settings ...................................................................................................................................................7-10

Peripheral Device Settings ...........................................................................................................................................7-13

Network Settings..............................................................................................................................................................7-15

DICOM Settings ................................................................................................................................................................7-17

Service ..................................................................................................................................................................................7-24

Info ......................................................................................................................................................................................... 7-25

Chapter 8 Maintenance

Operational Environment ........................................................................................................ 8-3

Product Maintenance................................................................................................................ 8-4

Cleaning and disinfecting ............................................................................................................................................... 8-4

Accuracy Checks ................................................................................................................................................................. 8-5

Battery Pack Management ...................................................................................................... 8-6

Replacing the Battery Pack ............................................................................................................................................. 8-6

Recharging the Battery Pack ..........................................................................................................................................8-7

Storing the Battery Pack ..................................................................................................................................................8-9

Disposing of the Battery Pack ....................................................................................................................................... 8-9

Information Maintenance ...................................................................................................... 8-10

Backing Up User Setting ................................................................................................................................................8-10

Backing Up Patient Information .................................................................................................................................8-10

Software...............................................................................................................................................................................8-10

17

Table of Contents

Chapter 9 Probes

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

Ultrasound Transmission Gel ......................................................................................................................................... 9-8

Using Sheaths ...................................................................................................................................................................... 9-9

Probe Safety Precautions ..............................................................................................................................................9-10

Cleaning and Disinfecting the Probe .......................................................................................................................9-12

Biopsy .........................................................................................................................................9-21

Biopsy Kit Components .................................................................................................................................................9-21

Using the Biopsy Kit ........................................................................................................................................................9-22

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

Cleaning and Disinfecting the Biopsy Kit ...............................................................................................................9-28

Reference Manual

Samsung Medison is providing an additional PT60A Reference Manual (English version).





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 Shocks ..............................................1-7

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

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

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

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





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

Safety Notes .............................................................................1-17

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





Biological Safety ........................................... 1-18

ALARA Principle .....................................................................1-18





Protecting the Environment ........................ 1-33

Correct Disposal of This Product

(Waste Electrical & Electronic Equipment)...................1-33





Battery Pack .................................................. 1-34

Correct Disposal of Batteries in This Product ..............1-35

Chapter 1

Chapter 1 Safety

Safety

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Samsung PT60A User manual

Samsung PT60A User manual

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