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 1.01.00
English
M357-E10100-01
PROPRIETRAY INFORMATION AND SOFTWARE LICENSE
The Customer shall keep condential 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 modication, the Customer shall return to
Samsung Medison all such proprietary information.
Safety Requirements
■■
Classications:
■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 ammable anesthetic material with air or
with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a ammable
anesthetic mixture with air or with oxygen or nitrous oxide.
■X
Mode of operation: Continuous operation
■■
Electromechanical safety standards met:
■X
Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential
Performance [IEC 60601-1:2005]
■X
Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential
Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and
Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC606012-37:2007]
■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 CSA symbol for Canada and United States of America
This is manufacturer’s declaration of product compliance with applicable EEC
directive(s) and the European notied body.
This is manufacturer’s declaration of product compliance with applicable EEC
directive(s).
Read This First
How to Use Your Manual
This manual addresses the reader who is familiar with ultrasound techniques. Only medical doctors
or persons supervised by medical doctors should use this system. Sonography training and clinical
procedures are not included here. This manual is not intended to be used as training material for the
principles of ultrasound, anatomy, scanning techniques, or applications. You should be familiar with all of
these areas before attempting to use this manual or your ultrasound system.
This manual does not include diagnosis results or opinions. Also, check the measurement reference for
each application’s result measurement before the nal diagnosis.
It is useless to make constant or complex adjustments to the equipment controls. The system has been
preset at the factory to produce an optimum image in the majority of patients. User adjustments are not
usually required. If the user wishes to change image settings, the variables may be set as desired. Optimal
images are obtained with little diculty.
We are not responsible for errors that occur when the system is run on a user’s PC.
Non-Samsung Medison product names may be trademarks of their respective owners.
Please keep this operation manual close to the product as a reference when using the system.
For safe use of this product, you should read ‘Chapter1. Safety’ and ‘Chapter8. Maintenance’ in this
manual, prior to starting to use this system.
NOTE: Some features are not available in some countries. The features with options, and
specifications that this manual present can be changed without notice. Government approval is still
pending in some nations.
Conventions Used in This Manual
DANGER: Describes precautions necessary to prevent user hazards of great urgency. Ignoring a
DANGER warning will risk life-threatening injury.
WARNING: Used to indicate the presence of a hazard that can cause serious personal injury, or
substantial property damage.
CAUTION: Indicates the presence of a hazard that can cause equipment damage.
NOTE: A piece of information useful for installing, operating and maintaining a system. Not related
to any hazard.
If You Need Assistance
If you need any assistance with the equipment, like the service manual, please contact the Samsung
Medison Customer Service Department or one of their worldwide customer service representatives,
immediately.
Revision History
DOCUMENTDAT EREASON FOR CHANGE
M357-E10100-012012-05-15Initial Release
System Upgrades and Manual Set Updates
Samsung Medison Ultrasound is committed to innovation and continued improvement. Upgrades may be
announced that consist of hardware or software improvements. Updated manuals will accompany those
system upgrades.
Verify thatCheck 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
Chapter1 Safety
Indication for Use .......................................................................................................................................... 1-3
Prevention of Electric Shock .......................................................................................................................................... 1-8
ECG-Related Information ..............................................................................................................................................1-10
Moving the Equipment ..................................................................................................................................................1-19
ALARA Principle ................................................................................................................................................................1-23
Training ................................................................................................................................................................................1-36
Control Panel .....................................................................................................................................................................2-10
Power Supply ..................................................................................................................................................3-3
Powering On ........................................................................................................................................................................ 3-3
Probe Selection and Application ................................................................................................................................. 3-5
Renaming a Userset .......................................................................................................................................................... 3-5
Patient Information ......................................................................................................................................3-6
Patient Information for Application ............................................................................................................................ 3-8
Finding Patient Information .........................................................................................................................................3-15
Diagnosis Mode Type ....................................................................................................................................................... 4-3
Basic Use ................................................................................................................................................................................ 4-4
M Mode ................................................................................................................................................................................4-19
Color Doppler Mode .......................................................................................................................................................4-22
Power Doppler Mode .....................................................................................................................................................4-27
2D/C Live Mode ................................................................................................................................................................4-48
3D Stand By .......................................................................................................................................................................4-56
3D View - MPR ...................................................................................................................................................................4-60
3D XI ......................................................................................................................................................................................4-80
XI VOCAL .............................................................................................................................................................................4-90
XI STIC ...................................................................................................................................................................................4-98
3D Utility Menu ............................................................................................................................................................. 4-102
Circumference and Area Measurement ..................................................................................................................5-16
Calculations by Application ................................................................................................................... 5-21
Things to note ...................................................................................................................................................................5-21
Common Measurement Methods .............................................................................................................................5-24
OB Calculations .................................................................................................................................................................5-29
Small Parts Calculations ................................................................................................................................................5-98
Store SR ............................................................................................................................................................................. 5-119
History ............................................................................................................................................................................... 5-125
CINE / LOOP .....................................................................................................................................................6-3
Body Marker ......................................................................................................................................................................6-12
Saving, Playing and Transferring Images ......................................................................................................... 6-14
Playing Images ..................................................................................................................................................................6-15
System Settings .............................................................................................................................................7-3
General .................................................................................................................................................................................. 7-4
User Dened Key ..............................................................................................................................................................7-20
Auto Calc .............................................................................................................................................................................7-44
About ....................................................................................................................................................................................7-45
Touch Menu Design .......................................................................................................................................................7-47
General ................................................................................................................................................................................7-50
Post Curve ...........................................................................................................................................................................7-75
Help .......................................................................................................................................................................................7-91
System Maintenance ...................................................................................................................................8-4
Cleaning and disinfections ............................................................................................................................................ 8-4
Cleaning Air Filters ............................................................................................................................................................. 8-7
Data Maintenance ........................................................................................................................................8-8
User Setting Back up ......................................................................................................................................................... 8-8
Patient information Back-up .......................................................................................................................................... 8-8
Ultrasound transmission Gel ......................................................................................................................................... 9-9
Cleaning and Disinfecting the Probe .......................................................................................................................9-13
Using the Biopsy Kit ........................................................................................................................................................9-23
Cleaning and Disinfecting Biopsy Kit .......................................................................................................................9-25
Assembling the Biopsy Kit ............................................................................................................................................9-27
** Reference Manual
Samsung Medison is providing an additional ACCUVIX XG Reference Manual. GA tables and references
for each application are included in the Reference Manual.
20
Chapter1
Safety
Indication for Use ........................................... 1-3
Waste Electrical and Electronic Equipment ................1-37
Chapter 1 Safety
Indication for Use
The ACCUVIX XG Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound
imaging and uid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Intra-operative, Pediatric, Small Organs, Neonatal
Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (conventional, supercial), Cardiac
Adult, Cardiac Pediatric and Peripheral-vessel.
Contraindications
The ACCUVIX XG system is not intended for ophthalmic use or any use causing the acoustic beam to pass
through the eye.
CAUTION:
Federal law restricts this device to sale by or on the order of a physician.
X
The method of application or use of the device is described in the manual 'Chapter 3. Starting
X
Diagnosis' and 'Chapter 4. Diagnosis Modes'.
1-3
Operation Manual
Safety Sign
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 XG is intended for use by, or by the order of, and under the supervision of, a licensed physician
who is qualied for direct use of the medical device.
Safety Symbols
The International Electro Technical Commission (IEC) has established a set of symbols for medical
electronic equipment, which classify a connection or warn of potential hazards. The classications and
symbols are shown below.
SymbolsDescriptionSymbolsDescription
AC (alternating current) voltage sourceLeft and right Audio / Video input
Power switch (Supplies/cuts the power
for product)
OFF (Cuts the power to a part of the
product)
ON (Supplies power to a part of the
product)
Indicates dangerous voltages over
1000V AC or over 1500V DC.
Left and right Audio / Video output
Remote print output
Foot switch connector
ECG connector
USB connector
Microphone connector
Identies an equipotential ground.
1-4
Chapter 1 Safety
SymbolsDescriptionSymbolsDescription
Identies the point where the system
safety ground is fastened to the
chassis. Protective earth connected to
conductive parts of Class I equipment
for safety purposes.
Probe connector
Data Output port
Data Input port Refer to the operation manual
Data Input/Output portDo not sit on control panel
WARNING: The accompanying
information must be followed to
prevent serious accidents and/or
damage to property.
CAUTION: The accompanying
information helps to avoid accidents
and/or damage to property.
Protection against the eects of
immersion.
Protection against dripping water.
ESD (Electrostatic discharge) caution
symbol
Do not push the product
Do not lean against the product
Follow the operation manual
Symbols
SymbolsDescriptionSymbolsDescription
Authorised Representative In The
European Community
Manufacturer
1-5
Operation Manual
Labels
To protect the system, you may see ‘Warning’ or ‘Caution’ marked on the surface of the product.
1-6
[Label 1. ID label]
[Label 2. Marked below OUTLET]
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 ษᝎ᪅
.
Не толкайте изделие и не опирайтесь
на
него.
A T T E N T I O N
Chapter 1 Safety
[Label 3. Safety note for “TIP-OVER” Precaution]
[Label 4. Prohibition of seating on Control panel]
1-7
Operation Manual
Electrical Safety
This equipment has been veried as a Class I device with Type BF applied parts.
CAUTION:
As for US requirement, the LEAKAGE CURRENT might be measured from a center-tapped circuit
X
when the equipment connects in the United States to 240V supply system.
To help assure grounding reliability, connect to a “hospital grade” or “hospital only” grounded
X
power outlet.
Prevention of Electric Shock
In a hospital, dangerous currents are due to the potential dierences between connected equipment
and touchable conducting parts found in medical rooms. The solution to the problem is consistent
equipotential bonding. Medical equipment is connected with connecting leads made up of angled
sockets to the equipotential bonding network in medical rooms.
[Figure 1.1 Equipotential bonding]
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 congurations shall
comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3
Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical
equipment congures a medical system and is therefore responsible that the system complies with the
requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority
over the above-mentioned requirements. If in doubt, consult your local representative or the technical
service department.
1-8
Chapter 1 Safety
WARNING:
Electric shock may exist result if this system, including and all of its externally mounted recording
X
and monitoring devices, is not properly grounded.
Do not remove the covers on the system; hazardous voltages are present inside. Cabinet panels
X
must be in place while the system is in use. All internal adjustments and replacements must be
made by a qualified Samsung Medison Customer Service Department.
Check the face, housing, and cable before use. Do not use and disconnect the power source, if
X
the face is cracked, chipped, or torn, the housing is damaged, or if the cable is abraded.
Always disconnect the system from the wall outlet prior to cleaning the system.
X
All patient contact devices, such as probes and ECG leads, must be removed from the patient
X
prior to application of a high voltage defibrillation pulse.
The use of flammable anesthetic gas or oxidizing gases (N2O) should be avoided.
X
Avoid places where the system is likely to be difficult to operate the disconnection device.
X
Do not use HF surgical equipment with the system. Any malfunctions in the HF surgical
X
equipment may result in burns to the patient.
CAUTION:
The system has been designed for 100-120VAC and 200-240VAC; you should select the input
X
voltage of 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.
An isolation transformer protects the system from power surges. The isolation transformer
X
continues to operate when the system is in standby.
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
X
maximum total load of 200W. Use these outlets only 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.
Do not connect any peripheral devices not listed in this manual to the auxiliary socket outlets of
X
the system.
Do not touch SIP/SOP and the patient simultaneously. There is a risk of electric shock from
X
leakage current.
1-9
Operation Manual
ECG-Related Information
WARNING:
This device is not intended to provide a primary ECG monitoring function, and therefore does
X
not have means of indicating an inoperative electrocardiograph.
Do not use ECG electrodes of HF surgical equipment. Any malfunctions in the HF surgical
X
equipment may result in burns to the patient.
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.
X
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. During low humidity conditions, electrical charges naturally build up on individuals,
creating static electricity. An ESD occurs when an individual with an electrical energy build-up comes in
contact with conductive objects such as metal doorknobs, le cabinets, computer equipment, and even
other individuals. The static shock or ESD is a discharge of the electrical energy build-up from a charged
individual to a lesser or non-charged individual or object.
1-10
CAUTION:
The level of electrical energy discharged from a system user or patient to an ultrasound system
X
can be significant enough to cause damage to the system or probes.
Always perform the pre-ESD preventive procedures before using connectors marked with the
X
ESD warning label.
Apply anti-static spray on carpets or linoleum.
−
Use anti-static mats.
−
Ground the product to the patient table or bed.
−
It is highly recommended that the user be given training on ESD-related warning symbols and
X
preventive procedures.
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