Samsung Accuvix A30 User manual Vol.1

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
WARRANTY
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.
MANUFACTURER : SAMSUNG MEDISON CO., LTD.
42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Customer Service Department : SAMSUNG MEDISON CO., LTD.
EC Representative : SAMSUNG ELECTRONICS (UK) LTD.
TEL : 82-2-2194-1234 FAX : 82-2-2194-1071
Website: www.samsungmedison.com
Blackbushe Business Park, Saxony Way,
Yateley, Hampshire, GU46 6GG, UK
Diagnostic Ultrasound System
Operation Manual
Version 2.00.00
English
MI68-02411A
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 equipment
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 60601-1-6:2006]
X 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]
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: General Requirements for Safety – 1 Collateral Standard: Safety
Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]
X Medical Electrical Equipment, Part 1: General Requirements for Safety – 2 Collateral Standard:
Electromagnetic Compatibility – Requirements and Test [IEC 60601-1-2:2001, A1:2004]
X Medical Electrical Equipment, Part 1: General Requirements for Safety – 4 Collateral Standard:
Programmable Electrical Medical Systems [IEC 60601-1-4: 1996, A1:1999]
X 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]
X Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]
X Medical Electrical Equipment, Part 1: General Requirements for Safety [UL60601-1:2003]
X Medical Electrical Equipment, Part 1: General Requirements for Safety [CAN/CSA 22.2 No.601.1-M90:1990,
with R2003, with R2005]
X Biological Evaluation of Medical Devices [ISO10993 : 2009]
X Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment
[IEC61157:2007]
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 DAT E NOTE
v2.00.00-02 2012-06-07 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.
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 .............................................................................................................................................. 1-9
Prevention of Electric Shock .......................................................................................................................................... 1-9
ECG-Related Information ..............................................................................................................................................1-11
ESD .........................................................................................................................................................................................1-11
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 2 Introduction
Specifications..................................................................................................................................................2-3
Product Configuration ................................................................................................................................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
15
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 .............................................................................................................................................3-22
Work list Search.................................................................................................................................................................3-25
Searching for Patient Information .............................................................................................................................3-26
Restarting the Exam ........................................................................................................................................................3-34
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 ................................................................................................................................................................................4-20
Color Doppler Mode .......................................................................................................................................................4-23
Power Doppler Mode .....................................................................................................................................................4-28
PW Spectral Doppler Mode ..........................................................................................................................................4-31
CW Spectral Doppler Mode .........................................................................................................................................4-36
TDI Mode .............................................................................................................................................................................4-38
TDW Mode ..........................................................................................................................................................................4-40
ElastoScan Mode ..............................................................................................................................................................4-42
Combined Mode ........................................................................................................................................ 4-49
2D/C/PW Mode .................................................................................................................................................................4-49
2D/PD/PW Mode ..............................................................................................................................................................4-49
2D/C/CW Mode .................................................................................................................................................................4-49
2D/PD/CW Mode ..............................................................................................................................................................4-49
2D/C/M Mode ....................................................................................................................................................................4-50
Dual Live Mode .................................................................................................................................................................4-50
2D/TDI/TDW .......................................................................................................................................................................4-50
16
Table of Contents
MULTI-IMAGE MODE ................................................................................................................................. 4-52
Dual Mode ..........................................................................................................................................................................4-52
Quad Mode .........................................................................................................................................................................4-53
3D/4D Mode................................................................................................................................................. 4-54
3D Stand By ........................................................................................................................................................................4-58
3D View - MPR ...................................................................................................................................................................4-62
VOCAL ..................................................................................................................................................................................4-72
3D XI ......................................................................................................................................................................................4-81
XI VOCAL ..............................................................................................................................................................................4-90
4D ...........................................................................................................................................................................................4-97
XI STIC ...................................................................................................................................................................................4-98
3D Utility Menu .............................................................................................................................................................. 4-102
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 ..................................................................................................................5-17
Volume Measurement ....................................................................................................................................................5-19
Calculations by Application ................................................................................................................... 5-22
Things to note ...................................................................................................................................................................5-22
Common Measurement Methods .............................................................................................................................5-27
OB Calculations .................................................................................................................................................................5-32
Gynecology Calculations...............................................................................................................................................5-41
Cardiac Calculations ........................................................................................................................................................5-44
Vascular Calculations ......................................................................................................................................................5-60
Fetal Heart Calculations .................................................................................................................................................5-71
Urology Calculations .......................................................................................................................................................5-75
Abdomen Calculations .................................................................................................................................................5-79
Small Parts Calculations ................................................................................................................................................5-82
TCD Calculations .............................................................................................................................................................5-87
Pediatric Hip Calculations .............................................................................................................................................5-89
Musculoskeletal Calculations ......................................................................................................................................5-91
17
Operation Manual
Reports ........................................................................................................................................................... 5-92
Report View ........................................................................................................................................................................5-92
Editing Reports .............................................................................................................................................................. 5-100
Data Management ........................................................................................................................................................ 5-107
Closing Reports .............................................................................................................................................................. 5-108
Reference Manual
Samsung Medison is providing an additional Accuvix A30 Reference Manual (English version).
18
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 ................................................1-9
Prevention of Electric Shock ................................................1-9
ECG-Related Information ....................................................1-11
ESD ..............................................................................................1-11
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
Indication for Use
The Accuvix A30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.

Contraindications

The Accuvix A30 system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
CAUTION:
X
Federal law restricts this device to sale by or on the order of a physician.
X
The method of application or use of the device is described in the manual ‘Chapter 3. Starting Diagnosis’ and ‘Chapter 4. Diagnosis Modes’.
1-3
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.
Accuvix A30 is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of the medical device.

Safety Symbols

The International Electrotechnical Commission (IEC) has established a set of symbols for medical electronic equipment, which classify a connection or warn of potential hazards. The classifications and symbols are shown below:
Symbols Description Symbols Description
AC (Alternating Current) voltage source Left and right Audio / Video input
Electric shock hazard warning Left and right Audio / Video output
Classification based on degree of protection against electric hazard (Type BF)
Classification based on degree of protection against electric hazard (Type CF)
Power switch (Supplies/cuts the power to the product)
OFF (Cuts the power to a part of the product)
WARNING: The accompanying information must be followed to prevent serious accidents and/or damage to property.
Remote print output
Foot switch connector
ECG connector
USB connector
Microphone connector
1-4
CAUTION: The accompanying information helps to avoid accidents and/or damage to property.
Protection against the effects of immersion
Chapter 1 Safety

Symbols Description Symbols Description

Refer to the operation manual Protection against dripping water
ON (Supplies power to a part of the product)
Identifies an equipotential ground ESD (Electrostatic Discharge) caution
Indicates dangerous voltages over 1000V AC or 1500V DC
Protective earth connected to conductive parts of Class I equipment for safety purposes
Data Output port Do not lean against the product
Data Input port Follow the operation manual
Data Input/Output port
Probe connector
Do not sit on the control panel
Do not push the product

Symbols

Symbols Description Symbols Description
Authorized Representative In The European Community
Manufacturer
1-5
Operation Manual

Labels

Phrases containing the words ‘warning’ and/or ‘caution’ are displayed on the product’s surface in order to protect it.
1-6
[Label 1. ID label]
275-K-A858C
Do not push the product with excessive force or lean against it.
䇋࣓⫼࡯᥼ѻક⾈៪䴴೼݊ϞDŽ
ŝࠥ⦽ ⯹ᮝಽ ᱽ⣩ᮥ ၡÑӹ ʑݡḡ ษᝎ᜽᪅
.
Не толкайте изделие и не опирайтесь на
него.
A T T E N T I O N
[Label 2. Tip-over caution label]
Chapter 1 Safety
[Label 3. Control panel caution label]
1-7
Operation Manual
MADE IN KOREA
275-K-A544C
MADE IN KOREA
275-K-A511C
MADE IN KOREA
275-K-B083B
SAMSUNG MEDISON CO., LTD.
CW 2.0
SAMSUNG MEDISON CO., LTD.
CW 4.0
SAMSUNG MEDISON CO., LTD.
CW 6.0
[Label 4. Probe ID Label]
1-8
Electrical Safety
This equipment has been verified as a Class I device with Type BF applied parts.
CAUTION:
X
As for US requirement, the LEAKAGE CURRENT might be measured from a center-tapped circuit when the equipment connects in the United States to 240V supply system.
X
To help assure grounding reliability, connect to a “hospital grade” or “hospital only” grounded power outlet.

Prevention of Electric Shock

Chapter 1 Safety
In a hospital environment, hazardous current can form due to potential differences between exposed conductive parts and connected devices. The solution to the problem is consistent equipotential bonding. Medical equipment is connected with connecting leads made up of sockets which are angled to the equipotential bonding network in medical rooms.
Connection Lead (Socket)
Equipotential Connector
[Figure 1.1 Equipotential Bonding]
Equipotential Terminal
Earth in Medical
1-9
Operation Manual
Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data-processing equipment). Furthermore, all configurations must comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible for the system complying with the requirements for medical electrical systems.
WARNING:
X
Electric shock may result if this system, including all of its externally mounted recording and monitoring devices, is not properly grounded.
X
Never remove the cover from the product. Hazardously high voltage flows through the product. All internal adjustments and replacements must be made by a qualified Samsung Medison Customer Service Department.
X
Always check the product’s casing, cables, cords, and plugs for damage before using the product. Disconnect and do not use the power source if the face is cracked, chipped, torn, the housing is damaged, or if the cable is abraded.
X
Always disconnect the system from the wall outlet prior to cleaning it.
X
All patient contact devices, such as probes and ECG leads, must be removed from the patient prior to the application of a high voltage defibrillation pulse.
X
The use of flammable anesthetic gas or oxidizing gases (N2O) should be avoided. Doing so may cause an explosion.
X
Avoid placing the system where it is likely to be difficult to operate, or disconnect.
X
Do not use HF surgical equipment with the system. Any malfunctions in the HF surgical equipment may result in burns to the patient.
X
The System must only be connected to a supply mains with protective earth to avoid risk of electric shock.
1-10
CAUTION:
X
The system has been designed for 100-120VAC and 200-240VAC; you should select the input voltage of the printer and VCR. Prior to connecting a peripheral power cord, verify that the voltage indicated on the power cord matches the voltage rating of the peripheral device.
X
An isolation transformer protects the system from power surges. This continues to operate when the system is on standby.
X
Do not immerse the cable in liquids. Cables are not waterproof.
X
The auxiliary socket outlets installed on this system are rated 100-120V and 200-240V, with a maximum total load of 150VA. Only use these outlets for supplying power to equipment that is intended to be part of the ultrasound system. Do not connect additional multiple-socket outlets or extension cords to the system.
X
Do not connect any peripheral devices not listed in this manual to the auxiliary socket outlets of the system.
X
Do not touch SIP/SOP and the patient simultaneously. There is a risk of electric shock from current leakage.
Chapter 1 Safety

ECG-Related Information

WARNING:
X
This product does not support ECG monitoring. Therefore, it will not recognize incompatible ECG signals.
X
Do not use the ECG electrodes of HF surgical equipment. Any malfunctions in the HF surgical equipment may result in burns to the patient.
X
Do not use ECG electrodes during cardiac pacemaker procedures or other electrical stimulators.
X
Do not use ECG leads and electrodes in an operating room.
ESD
Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air conditioning. The static shock, or ESD, is a discharge of the electrical energy build-up from a charged individual to a lesser or uncharged individual or object. An ESD occurs when an individual with an electrical energy build-up comes in to contact with conductive objects such as metal doorknobs, file cabinets, computer equipment, and even other individuals.
CAUTION:
X
The level of electrical energy discharged from a system user or a patient to an ultrasound system can be significant enough to cause damage to the system or probes.
X
Always perform the pre-ESD preventive procedures before using connectors marked with the ESD warning label.
− Apply anti-static spray to carpets or linoleum.
− Use anti-static mats.
− Ground the product to the patient table or bed.
X
It is highly recommended that the user be given training on ESD-related warning symbols and preventive procedures.
1-11
Operation Manual
EMI
This product complies with EMI (Electromagnetic Interference) standards. However, using the system inside an electromagnetic field can lower the quality of ultrasound images and even damage the product.
If this occurs often, Samsung Medison suggests a review of the environment in which the system is being used, to identify possible sources of radiated emissions. These emissions could be from other electrical devices used within the same room or an adjacent room. Communication devices, such as cellular phones and pagers, can cause these emissions. The existence of radios, TVs, or microwave transmission equipment nearby can also cause interference.
CAUTION: In cases where EMI is causing disturbances, it may be necessary to relocate the system.
EMC
The testing for the EMC (Electromagnetic Compatibility) of this system has been performed according to the international standard for EMC with medical devices (IEC60601-1-2). This IEC standard was adopted in Europe as the European norm (EN60601-1-2).
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment guidance
RF Emission CISPR 11
RF Emission CISPR 11
Harmonic Emission IEC 61000-3-2
Flicker Emission IEC 61000-3-3
Group 1
Class B
Class A
Complies
The Ultrasound System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The Ultrasound System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
1-12
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