Samsung ACCUVIX A30 User manual

ACCUVIX A30
Samsung
Brand
Samsung
Model
ACCUVIX A30
Type
User manual
Volume 1
Samsung Medison provides the following warranty to the purchaser of this unit. This warranty is valid for
a period of one year from the date of installation and covers all problems caused by faulty workmanship
or faulty material. Samsung Medison will, as sole and exclusive remedy and at no charge, replace any such
defective unit returned to Samsung Medison within the designated warranty period.
The warranty does not cover damages and loss caused by outside factors including, but not limited to, re,
ood, storm, tidal wave, lightning, earthquake, theft, abnormal conditions of operation, and intentional
destruction of the equipment. Damage caused by equipment relocation is not covered.
The warranty is void in cases where the equipment has been damaged as a result of an accident, misuse,
abuse, dropping, or when attempts to modify or alter any part or assembly of the equipment have taken
place.
Parts with cosmetic defects or deterioration will not be replaced. Replacement of batteries, training
materials, and supplies are not covered.
Samsung Medison will not be responsible for incidental or consequential damages of any kind arising
from or connected with the use of the equipment.
Samsung Medison will not be responsible for any loss, damage, or injury resulting from a delay in services
rendered under the warranty
This limited warranty is in lieu of all other warranties expressed or implied, including warranties of
merchant ability or tness for any particular use. No representative or other person is authorized to
represent or assume for Samsung Medison any warranty liability beyond that set forth herein.
Defective equipment shipped from you to Samsung Medison must be packed in the replacement
cartons. Shipping and insurance costs are the responsibility of the customer. To return defective material
to Samsung Medison contact the Samsung Medison Customer Service Department.
Samsung Medison or a local distributor will make available, upon request, circuit diagrams, a component
parts list, descriptions, calibration instructions and other information which will assist your appropriately
quali ed technical personnel to repair those parts of the equipment which are designed by Samsung
Medison as repairable.
CAUTION: United State federal law restricts this device to sale by or on the order of physicians.
WARRANTY
MANUFACTURER : SAMSUNG MEDISON CO., LTD.
42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Customer Service Department : SAMSUNG MEDISON CO., LTD.
TEL : 82-2-2194-1234 FAX : 82-2-2194-1071
Website: www.samsungmedison.com
EC Representative : SAMSUNG ELECTRONICS (UK) LTD.
Blackbushe Business Park, Saxony Way,
Yateley, Hampshire, GU46 6GG, UK
Samsung Medison provides the following warranty to the purchaser of this unit. This warranty is valid for
a period of one year from the date of installation and covers all problems caused by faulty workmanship
or faulty material. Samsung Medison will, as sole and exclusive remedy and at no charge, replace any such
defective unit returned to Samsung Medison within the designated warranty period.
The warranty does not cover damages and loss caused by outside factors including, but not limited to, re,
ood, storm, tidal wave, lightning, earthquake, theft, abnormal conditions of operation, and intentional
destruction of the equipment. Damage caused by equipment relocation is not covered.
The warranty is void in cases where the equipment has been damaged as a result of an accident, misuse,
abuse, dropping, or when attempts to modify or alter any part or assembly of the equipment have taken
place.
Parts with cosmetic defects or deterioration will not be replaced. Replacement of batteries, training
materials, and supplies are not covered.
Samsung Medison will not be responsible for incidental or consequential damages of any kind arising
from or connected with the use of the equipment.
Samsung Medison will not be responsible for any loss, damage, or injury resulting from a delay in services
rendered under the warranty
This limited warranty is in lieu of all other warranties expressed or implied, including warranties of
merchant ability or tness for any particular use. No representative or other person is authorized to
represent or assume for Samsung Medison any warranty liability beyond that set forth herein.
Defective equipment shipped from you to Samsung Medison must be packed in the replacement
cartons. Shipping and insurance costs are the responsibility of the customer. To return defective material
to Samsung Medison contact the Samsung Medison Customer Service Department.
Samsung Medison or a local distributor will make available, upon request, circuit diagrams, a component
parts list, descriptions, calibration instructions and other information which will assist your appropriately
quali ed technical personnel to repair those parts of the equipment which are designed by Samsung
Medison as repairable.
CAUTION: United State federal law restricts this device to sale by or on the order of physicians.
WARRANTY
MANUFACTURER : SAMSUNG MEDISON CO., LTD.
42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Customer Service Department : SAMSUNG MEDISON CO., LTD.
TEL : 82-2-2194-1234 FAX : 82-2-2194-1071
Website: www.samsungmedison.com
EC Representative : SAMSUNG ELECTRONICS (UK) LTD.
Blackbushe Business Park, Saxony Way,
Yateley, Hampshire, GU46 6GG, UK
Operation Manual
Version 2.01.00
English
Diagnostic Ultrasound System
MI68-02577A
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 systems contain Samsung Medison 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
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 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]
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
This is the CSA symbol for Canada and the United States of America.
This is the 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.
Read This First
You should be familiar with all of these areas before attempting to use this manual or your ultrasound
system.
Please keep this user guide close to the product as a reference when using the system.
For safe use of this product, you should read ‘Chapter 1. Safety’ and ‘Chapter 8. Maintenance’ in this
manual, prior to starting to use this system.
This manual does not include diagnosis results or opinions. Also, check the measurement reference for
each application’s result measurement before making the final 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 qualified 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.
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: 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: The accompanying information covers an installation, operation, or maintenance
procedure that requires careful attention of the user, but has little chance of leading directly to a
dangerous situation.
If You Need Assistance
If you require a copy of the service manual or assistance with the product, please contact Samsung
Medison customer service department or your distributor.
Revision History
This operation manual’s revision history is as follows:
VERSION DATE NOTE
v2.01.00-00 2013-05-23 Initial Release
System Upgrades and Manual Set Updates
Upgrades may be announced that consist of hardware or software improvements. Updated manuals will
accompany those system upgrades.
Check if this version of the manual is correct for the system version. If not, please contact the Customer
Service Department.
15
Table of Contents
Table of Contents – Volume 1
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 Notes .......................................................................................................................................................................1-19
Biological Safety ......................................................................................................................1-21
ALARA Principle ................................................................................................................................................................1-21
Environmental Protection ......................................................................................................1-35
Correct Disposal of This Product (Waste Electrical & Electronic Equipment) ...........................................1-35
Chapter 2 Introduction
Specications.............................................................................................................................. 2-3
Product Conguration .............................................................................................................. 2-5
Monitor .................................................................................................................................................................................. 2-7
Control Panel ....................................................................................................................................................................... 2-9
Console ................................................................................................................................................................................2-14
Peripheral Devices ...........................................................................................................................................................2-16
Probes ................................................................................................................................................................................... 2-19
Accessories .........................................................................................................................................................................2-20
Optional Functions .......................................................................................................................................................... 2-21
16
Operation Manual
Chapter 3 Starting Diagnosis
Power Supply .............................................................................................................................. 3-3
Powering On ........................................................................................................................................................................ 3-3
Powering Off ........................................................................................................................................................................ 3-3
Probes & Applications .............................................................................................................. 3-4
Probe and Application Selection ................................................................................................................................. 3-5
Probe Userset Management .......................................................................................................................................... 3-6
Patient Information ................................................................................................................... 3-9
Patient Information Entry .............................................................................................................................................3-11
Changing Measurements .............................................................................................................................................3-23
Work list Search.................................................................................................................................................................3-26
Searching for Patient Information .............................................................................................................................3-27
Restarting the Exam ........................................................................................................................................................ 3-35
Chapter 4 Diagnosis Modes
Information ................................................................................................................................. 4-3
Diagnosis Mode Types ..................................................................................................................................................... 4-3
Basic Use ................................................................................................................................................................................ 4-4
Basic Mode .................................................................................................................................. 4-7
2D Mode ................................................................................................................................................................................ 4-7
M Mode ................................................................................................................................................................................4-22
Color Doppler Mode .......................................................................................................................................................4-25
Power Doppler Mode .....................................................................................................................................................4-30
PW Spectral Doppler Mode ..........................................................................................................................................4-33
CW Spectral Doppler Mode .........................................................................................................................................4-38
TDI Mode .............................................................................................................................................................................4-40
TDW Mode ..........................................................................................................................................................................4-42
ElastoScan Mode ..............................................................................................................................................................4-44
Combined Mode ......................................................................................................................4-51
2D/C/PW Mode .................................................................................................................................................................4-51
2D/PD/PW Mode ..............................................................................................................................................................4-51
2D/C/CW Mode ................................................................................................................................................................. 4-51
2D/PD/CW Mode .............................................................................................................................................................. 4-51
2D/C/M Mode ....................................................................................................................................................................4-52
Dual Live Mode .................................................................................................................................................................4-52
2D/TDI/TDW .......................................................................................................................................................................4-52
17
Table of Contents
MULTI-IMAGE MODE ...............................................................................................................4-54
Dual Mode ..........................................................................................................................................................................4-54
Quad Mode .........................................................................................................................................................................4-55
3D/4D Mode .............................................................................................................................. 4-56
3D Stand By ........................................................................................................................................................................4-60
3D View - MPR ...................................................................................................................................................................4-64
VOCAL ..................................................................................................................................................................................4-74
3D XI ......................................................................................................................................................................................4-83
XI VOCAL .............................................................................................................................................................................. 4-93
4D ........................................................................................................................................................................................ 4-100
XI STIC ................................................................................................................................................................................ 4-101
3D Utility Menu .............................................................................................................................................................. 4-105
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 Measurements ................................................................................................................................................5-11
Circumference and Area Measurement ..................................................................................................................5-19
Volume Measurement .................................................................................................................................................... 5-21
Calculations by Application ................................................................................................... 5-24
Things to note ...................................................................................................................................................................5-24
Common Measurement Methods .............................................................................................................................5-29
OB Calculations .................................................................................................................................................................5-34
Gynecology Calculations...............................................................................................................................................5-43
Cardiac Calculations ........................................................................................................................................................ 5-46
Vascular Calculations ......................................................................................................................................................5-64
Fetal Heart Calculations ................................................................................................................................................. 5-77
Urology Calculations .......................................................................................................................................................5-81
Abdomen Calculations .................................................................................................................................................5-85
Small Parts Calculations ................................................................................................................................................ 5-89
TCD Calculations .............................................................................................................................................................5-94
Pediatric Hip Calculations .............................................................................................................................................5-96
Musculoskeletal Calculations ......................................................................................................................................5-98
18
Operation Manual
Reports .......................................................................................................................................5-99
Report View ........................................................................................................................................................................5-99
Editing Reports .............................................................................................................................................................. 5-107
Data Management ........................................................................................................................................................ 5-117
Closing Reports .............................................................................................................................................................. 5-118
Reference Manual
Samsung Medison is providing an additional Accuvix A30 Reference Manual (English version).
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 ...............................................................................................1-12
EMC .............................................................................................1-12
Mechanical Safety ........................................ 1-19
Moving the Equipment .......................................................1-19
Safety Notes .............................................................................1-20
Biological Safety ........................................... 1-22
ALARA Principle .....................................................................1-22
Environmental Protection ........................... 1-36
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)...................1-36
Chapter 1
Safety
Chapter 1 Safety
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Samsung ACCUVIX A30 User manual

ACCUVIX A30
Samsung
Brand
Samsung
Model
ACCUVIX A30
Type
User manual
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