Samsung Sonoace R7 User manual
Volume 1
Diagnostic Ultrasound System
Operation Manual
Version 3.01.00
English
MI68-02773A
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 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 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
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 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 user guide close to the product as a reference when using the system.
For safe use of this product, you should read ‘Chapter1. Safety’ and ‘Chapter8. Maintenance’ in this
manual, prior to starting to use this system.
NOTE: Some features are not available in some countries. The features with options, and specifications
that this manual present can be changed without notice. Government approval is still pending in some
nations.
Conventions Used in This Manual
DANGER: Describes precautions necessary to prevent user hazards of great urgency. Ignoring a
DANGER warning will risk life-threatening injury.
WARNING: Used to indicate the presence of a hazard that can cause serious personal injury, or
substantial property damage.
CAUTION: Indicates the presence of a hazard that can cause equipment damage.
NOTE: A piece of information useful for installing, operating and maintaining a system. Not related
to any hazard.
If You Need Assistance
If you need any assistance with the equipment, like the service manual, please contact the Samsung
Medison Customer Service Department or one of their worldwide customer service representatives,
immediately.
Revision History
VERSION DAT E NOTE
v3.01.00-00 2013-09-26
v3.01.00-01 2013-11-28
Initial Release
Add State of California Proposition 65 Warning (US Only)
System Upgrades and Manual Set Updates
Samsung Medison Ultrasound is committed to innovation and continued improvement. Upgrades may be
announced that consist of hardware or software improvements. Updated manuals will accompany those
system upgrades.
Verify that Check if this version of the manual is correct for the system version. If not, please contact the
Customer Service Department.
Table of Contents
Table of Contents – Volume 1
Chapter 1 Safety
Indication for Use ....................................................................................................................... 1-3
Safety Signs ................................................................................................................................. 1-4
Safety Symbols .................................................................................................................................................................... 1-4
Symbols ................................................................................................................................................................................. 1-5
Labels ...................................................................................................................................................................................... 1-6
Electrical Safety .......................................................................................................................... 1-8
Prevention of Electric Shock .......................................................................................................................................... 1-8
ECG-Related Information ..............................................................................................................................................1-10
ESD .........................................................................................................................................................................................1-10
EMI .........................................................................................................................................................................................1-11
EMC........................................................................................................................................................................................1-11
Mechanical Safety .................................................................................................................... 1-18
Moving the Equipment ..................................................................................................................................................1-18
Safety Note .........................................................................................................................................................................1-19
Biological Safety ......................................................................................................................1-20
ALARA Principle ................................................................................................................................................................1-20
Environmental Protection ...................................................................................................... 1-33
Correct Disposal of This Product (Waste Electrical & Electronic Equipment) ............................................1-33
Chapter2 Introduction
Specications.............................................................................................................................. 2-3
Product Conguration and Installation ................................................................................ 2-6
Monitor ................................................................................................................................................................................. 2-9
Control Panel .....................................................................................................................................................................2-11
Console ................................................................................................................................................................................2-16
Peripheral Devices ..........................................................................................................................................................2-18
Probe .....................................................................................................................................................................................2-21
Accessories .........................................................................................................................................................................2-22
Optional Functions ..........................................................................................................................................................2-23
13
Operation Manual
Chapter3 Starting Diagnosis
Power Supply .............................................................................................................................. 3-3
Powering On ........................................................................................................................................................................ 3-3
Powering O ........................................................................................................................................................................ 3-3
Probes & Applications ............................................................................................................... 3-4
Probe Selection and Application ................................................................................................................................. 3-5
Changing Application ...................................................................................................................................................... 3-5
Editing Probe Preset Values ............................................................................................................................................ 3-5
Patient Information ................................................................................................................... 3-7
Patient Information for Application ............................................................................................................................ 3-9
Finding Patient Information .........................................................................................................................................3-15
Managing Patient Exams...............................................................................................................................................3-17
Changing Measurements .............................................................................................................................................3-23
Chapter4 Diagnosis Modes
Information ................................................................................................................................. 4-3
Diagnosis Mode Type ....................................................................................................................................................... 4-3
Basic Use ................................................................................................................................................................................ 4-4
Basic Mode .................................................................................................................................. 4-6
2D Mode ................................................................................................................................................................................ 4-6
Panoramic ..........................................................................................................................................................................4-13
M Mode ................................................................................................................................................................................4-15
Color Doppler Mode .......................................................................................................................................................4-17
Power Doppler Mode .....................................................................................................................................................4-20
PW Spectral Doppler Mode ..........................................................................................................................................4-22
CW Spectral Doppler Mode .........................................................................................................................................4-27
TDI Mode .............................................................................................................................................................................4-28
TDW Mode ..........................................................................................................................................................................4-29
ElastoScan Mode .............................................................................................................................................................4-30
Combined Mode ......................................................................................................................4-37
2D/C/PW Mode .................................................................................................................................................................4-37
2D/PD/PW Mode ..............................................................................................................................................................4-37
2D/C/CW Mode .................................................................................................................................................................4-37
2D/PD/CW Mode ..............................................................................................................................................................4-37
2D/C/M Mode ....................................................................................................................................................................4-38
2D/C Live Mode ................................................................................................................................................................4-38
14
Table of Contents
Multi-Image Mode ................................................................................................................... 4-39
Dual Mode ..........................................................................................................................................................................4-39
Quad Mode .........................................................................................................................................................................4-40
3D/4D Mode .............................................................................................................................. 4-41
3D/4D Mode .......................................................................................................................................................................4-41
3D StandBy Mode ............................................................................................................................................................4-43
3D View-MPR ......................................................................................................................................................................4-47
3D XI Mode (Optional) ...................................................................................................................................................4-63
Chapter5 Measurements and Calculations
Measurement Accuracy ............................................................................................................ 5-3
Causes of Measurement Errors ..................................................................................................................................... 5-3
Optimization of Measurement Accuracy .................................................................................................................. 5-5
Measurement Accuracy Table ....................................................................................................................................... 5-7
Basic Measurements ................................................................................................................. 5-9
Distance Measurement ..................................................................................................................................................5-11
Circumference and Area Measurement ..................................................................................................................5-16
Volume Measurement ....................................................................................................................................................5-18
Calculations by Application ................................................................................................... 5-21
Things to note ...................................................................................................................................................................5-21
Common Measurement Methods .............................................................................................................................5-25
OB Calculation ...................................................................................................................................................................5-31
Gynecology Calculation ................................................................................................................................................5-44
Cardiac Calculation ..........................................................................................................................................................5-51
Carotid Calculation ..........................................................................................................................................................5-63
Urology Calculation.........................................................................................................................................................5-75
Fetal Echo Calculation ....................................................................................................................................................5-80
LE Artery Calculation ......................................................................................................................................................5-85
UE Artery Calculation .....................................................................................................................................................5-95
LE Vein Calculation ....................................................................................................................................................... 5-100
UE Vein Calculation.......................................................................................................................................................5-104
Radiology Calculation ................................................................................................................................................. 5-109
TCD Calculation .............................................................................................................................................................5-117
Thyroid Calculation ......................................................................................................................................................5-123
Breast Calculation ......................................................................................................................................................... 5-125
Testicle Calculation ....................................................................................................................................................... 5-127
Supercial Calculation ................................................................................................................................................ 5-129
Pediatric Hips Calculation .......................................................................................................................................... 5-131
Musculoskeletal Calculation ..................................................................................................................................... 5-133
15
Operation Manual
Report ......................................................................................................................................5-134
Viewing Report .............................................................................................................................................................. 5-135
Video Out ......................................................................................................................................................................... 5-136
Editing Report ................................................................................................................................................................ 5-136
Adding Comment ......................................................................................................................................................... 5-138
Printing Report ............................................................................................................................................................... 5-139
Saving Report ................................................................................................................................................................. 5-139
Transferring Report ...................................................................................................................................................... 5-140
Stress Echo Report ........................................................................................................................................................ 5-140
Graph Function .............................................................................................................................................................. 5-141
Closing Report ................................................................................................................................................................ 5-145
** Reference Manual
Samsung Medison is providing an additional SONOACE R7 Reference Manual. GA tables and references for
each application are included in the Reference Manual.
16
Chapter1
Safety
Indication for Use .............................................1-3
Safety Signs ......................................................1-4
Safety Symbols ......................................................................... 1-4
Symbols ....................................................................................... 1-5
Labels ........................................................................................... 1-6
Electrical Safety ................................................1-8
Prevention of Electric Shock ................................................1-8
ECG-Related Information ....................................................1-10
ESD ..............................................................................................1-10
EMI ...............................................................................................1-11
EMC .............................................................................................1-11
Mechanical Safety ........................................ 1-18
Moving the Equipment .......................................................1-18
Safety Note ...............................................................................1-19
Biological Safety ........................................... 1-20
ALARA Principle .....................................................................1-20
Environmental Protection ........................... 1-33
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)...................1-33
Chapter 1 Safety
Indication for Use
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound
imaging and uid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic,
Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Supercial), Cardiac Adult, Cardiac Pediatric,
Peripheral vessel.
Contraindications
The SONOACE R7 system is not intended for ophthalmic use or any use causing the acoustic beam to pass
through the eye.
CAUTION:
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.
SONOACE R7 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.
Symbols Description Symbols Description
Alternating current voltage source Input port
CAUTION: Risk of electric shock Output port
Type BF applied part (Classication
based on degree of protection against
electric hazard)
Debrillation-proof type CF applied
part (Classication based on degree of
protection against electric hazard)
Power on/o ECG port
Power on USB port
Power o Network port
Print remote output
Foot Switch Port
1-4
Chapter 1 Safety
Symbols Description Symbols Description
WARNING: The accompanying
information must be followed to prevent
serious accidents and/or damage to
property.
Microphone Port
CAUTION: The accompanying
information helps to prevent minor
accidents and/or damage to property.
Refer to the operation manual.
Power ON for part of the product
Equipotentiality Probe port
Dangerous voltage (Indicates dangerous
voltages over 1000V AC or 1500V DC)
Protective earth (ground) Do not sit on the product.
Data output port Do not push the product.
Data input port Do not lean against the product.
IPX 7: Protected against the eects of
temporary immersion in water
IPX 1: Protected against vertically falling
water drops
IPX 8: Protected against the eects of
continuous immersion in water
CAUTION: Electrostatic sensitive devices
(ESD)
Data Input/Output port Follow the operation manual.
Symbols
Symbols Description Symbols Description
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]
275-K-A4288
[Label 2. Marked below OUTLET ]
[Label 3. Safety note for “TIP-OVER” Precaution]
Chapter 1 Safety
[Label 4. Prohibition of seating on Control panel]
1-7
Operation Manual
Electrical Safety
This product is categorized as a Class I device.
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
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.
1-8
[Figure 1.1 Equipotential bonding]
Chapter 1 Safety
Additional equipment connected to medical electrical equipment must comply with the respective IEC standards
(e.g., IEC 60950/EN 60950 for data processing equipment, IEC 60601-1/EN 60601-1) for medical devices).
Furthermore, all components of the product shall comply with the requirements for medical electrical systems IEC
60601-1-1/EN 60601-1-1. A person connecting additional equipment to signal input and output ports of medical
electrical equipment must verify that the equipment complies with IEC 60601-1-1/EN 60601-1-1.
WARNING:
X
Electric shock may exist result if this system, including and all of its externally mounted recording
and monitoring devices, is not properly grounded.
X
Do not remove the covers on the system; hazardous voltages are present inside. Cabinet panels
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.
X
Check the face, housing, and cable before use. Do not use and disconnect the power source, if
the face is cracked, chipped, or torn, the housing is damaged, or if the cable is abraded.
X
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
prior to application of a high voltage defibrillation pulse.
X
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
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.
CAUTION:
X
The system has been designed for 100-120VAC and 200-240VAC; you should select the input
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.
X
An isolation transformer protects the system from power surges. The isolation transformer
continues to operate when the system is in 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
maximum total load of 150W. 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.
X
Do not connect 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
leakage current.
1-9
Operation Manual
ECG-Related Information
WARNING:
X
This device is not intended to provide a primary ECG monitoring function, and therefore does
not have means of indicating an inoperative electrocardiograph.
X
Do not use 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.
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:
X
The level of electrical energy discharged from a system user or 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 on 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.
Chapter 1 Safety
EMI
Although this system has been manufactured in compliance with existing EMI (Electromagnetic Interference)
requirements, use of this system in the presence of an electromagnetic eld can cause momentary degradation
of the ultrasound image.
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 this system.
EMC
The testing for EMC (Electromagnetic Compatibility) of this system has been performed according to the
international standard for EMC with medical devices (IEC 60601-1-2). This IEC standard was adopted in Europe
as the European norm (EN 60601-1-2).
Guidance and manufacturer’s declaration - electromagnetic emission
This product is intended for use in the electromagnetic environment specied 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
building used for domestic purpose.
1-11
Operation Manual
Approved Cables, Transducers and Accessories for EMC
Approved Cable for ElectroMagnetic Compliance
Cables connected to this product may aect its emissions; Use only the cable types and lengths listed
below table.
Cable Type Length
VGA Shielded Normal
Parallel Shielded Normal
RS232C Shielded Normal
USB Shielded Normal
LAN (RJ45) Twisted pair Any
S-Video Shielded Normal
Foot Switch Shielded 2.73yd
B/W Printer Unshielded Coaxial Normal
MIC Unshielded Any
Printer Remote Unshielded Any
Audio R.L Shielded Normal
VHS Shielded Normal
ECG AUX input Shielded < 3m
e-Motion Marker Shielded 3m
Approved Transducer for ElectroMagnetic Compliance
The probe listed in ‘Chapter 9. Probes’ when used with this product, have been tested to comply with the
group1 class B emission as required by International Standard CISPR 11.
Approved Accessories for ElectroMagnetic Compliance
Accessories used with this product may eect its emissions.
CAUTION: When connecting other customer-supplied accessories to the system, such as a remote
printer or VCR, it is the user’s responsibility to ensure the electromagnetic compatibility of the
system. Use only CISPR 11 or CISPR 22, CLASS B compliant devices.
1-12
Chapter 1 Safety
WARNING: The use of cables, transducers, and accessories other than those specified may result in
increased emission or decreased Immunity of the Ultrasound System.
Immunity test IEC 60601 Test level Compliance level
Electrotatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage
dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
±6KV Contact
±8KV air
±2KV
for power supply lines
±1KV
for input/output lines
±1KV dierential mode
±2KV common mode
<5% Uт for 0.5cycle
(>95% dip in Uт)
40% Uт for 5 cycle
(60% dip in Uт)
70% Uт for 25 cycle
(30% dip in Uт)
<5% Uт for 5 s
(<95% dip in Uт )
±6KV Contact
±8KV air
±2KV
for power supply lines
±1KV
for input/output lines
±1KV dierential
mode
±2KV common mode
<5% Uт for 0.5cycle
(>95% dip in Uт)
40% Uт for 5 cycle
(60% dip in Uт)
70% Uт for 25 cycle
(30% dip in Uт)
<5% Uт for 5 s
(<95% dip in Uт )
ElectroMagnetic environment
- guidance
Floors should be wood,
concrete or ceramic tile.
If oors are covered with
synthetic material, the relative
humidity should be at least
30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of this product requires
continued operation during
power mains interruptions,
it is recommended that this
product be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60Hz)
magnetic eld
IEC 61000-4-8
NOTE: Uт is the a.c. mains voltage prior to application of the test level.
3 A/m 3 A/m
Power frequency magnetic
elds should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
1-13
Operation Manual
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
Test level
3 Vrms
150 kHz
to 80MHz
3 V/m
80 MHz
to 2.5GHz
Compliance
level
ElectroMagnetic
environment - guidance
0.01V Portable and mobile RF communications
equipment should be used no closer to any part
of the Ultrasound System, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
80MHz to 800MHz
800MHz to 2.5GHz
3V/m Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from xed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
b
a
Interference may occur in the vicinity of
equipment marked with the following symbol :
NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects and people.
a
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters,
an electromagnetic site survey should be considered. If the measured eld strength in the location in
which the Ultrasound System is used exceeds the applicable RF compliance level above, the Ultrasound
System should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Ultrasound System or using a shielded
location with a higher RF shielding eectiveness and lter attenuation.
b
Over the frequency range 150kHz to 80MHz, eld strengths should be less than [V1] V/m.
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