Samsung SonoAce R3 Service manual

ENGLISH

Document No. CSD-SMESAR3

Revision 01

Copyright SAMSUNG MEDISON Co., LTD.

Safety Requirements

Classifications:

-Type of protection against electrical shock: Class I

-Degree of protection against electrical shock (Patient connection):Type BF equipment

-Degree of protection against harmful ingress of water: Ordinary equipment

-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.

-Mode of operation: Continuous operation

Electromechanical safety standards met:

-IEC/EN 60601-1 Medical Electrical Equipment, Part 1General Requirements for Safety.

-IEC/EN 60601-1-1 Safety requirements for medical electrical systems.

-IEC/EN 60601-1-2 Electromagnetic compatibility -Requirements and tests.

-IEC/EN 60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

-IEC 61157 Declaration of acoustic output parameters.

-ISO 10993-1 Biological evaluation of medical devices.

-UL 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

-CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

Declarations:

This is CSA symbol for Canada and United States of America

This is manufacturer’s declaration of product compliance 0123 with applicable EEC directive(s) and the European notified

body.

This is manufacturer’s declaration of product compliance with applicable EEC directive(s).

This is GMP symbol for Good Manufacturing Practice of

Korea quality system regulation.

READ THIS FIRST

Before asking for the product to be repaired, read this service manual thoroughly, learn how to troubleshoot, and make sure you understand the precautions fully.

The repair of the system and the replacement of parts must be carried out by an authorized dealer or the customer service department of SAMSUNG MEDISON Co., Ltd.

The company is shall not be held liable for any injury and damage caused by not following this warning.

For safe use of this product, you should read ‘Chapter 2. Safety’ in this manual, prior to starting to

useing this system.

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.

Contents

Chapter 1. General Information
1.1	Overview	.......................................................................................................	1-1
1.2	FeaturesandAdvantagesofSonoAceR3..................................................		1-2
1.3	ProductConfiguration....................................................................................		1-3
	1.3.1	Console.........................................................................................	1-3
	1.3.2	LCDMonitor.................................................................................	1-4
	1.3.3	ControlPanel................................................................................	1-5
	1.3.4	Probe............................................................................................	1-5
1.4	Specifications..................................................................................................		1-6

Chapter 2. Safety
2.1	Overview	.......................................................................................................	2-1
2.2	Safety-RelatedInformation............................................................................		2-2
	2.2.1	SafetySymbols............................................................................	2-2
	2.2.2	LABEL...........................................................................................	2-3
2.3	ElectricalSafety..............................................................................................		2-4
	2.3.1	Prevention ElectricShock...........................................................	2-4
	2.3.2	ESD...............................................................................................	2-4
	2.3.3	EMI................................................................................................	2-5
	2.3.4	EMC..............................................................................................	2-5
2.4	MechanicalSafety..........................................................................................		2-11
	2.4.1	MovingEquipment.......................................................................	2-11
	2.4.2	SafetyNote...................................................................................	2-11
2.5	BiologicalSafety.............................................................................................		2-12
	2.5.1	ALARAPrinciple..........................................................................	2-12
2.6	EnvironmentalProtection..............................................................................		2-24

Contents

Chapter 3. Installing the Product
3.1	Overview	.......................................................................................................	3-1
3.2	Transportation................................................................................................		3-3
	3.2.1	PrecautionsforTransportation....................................................	3-3
	3.2.2	TemperatureandHumidity.........................................................	3-3
3.3	Unpacking	.......................................................................................................	3-4
	3.3.1	UnpackingtheBox.......................................................................	3-4
	3.3.2	CheckingPackagecontents.......................................................	3-5
3.4	PrecautionsforInstallation............................................................................		3-6
	3.4.1	Precautions...................................................................................	3-6
3.5	InstallationsProcedure..................................................................................		3-7
	3.5.1	InstallationSafety.........................................................................	3-7
	3.5.2	ConnectingthePowerCord........................................................	3-8
	3.5.3	ConnectingtheNetworkCable...................................................	3-9
	3.5.4	ConnectingtheProbe..................................................................	3-9
3.6	StartingtheProduct.......................................................................................		3-10
3.7	ShuttingdowntheProduct............................................................................		3-11
3.8	ConnectingthePeripherals...........................................................................		3-12
	3.8.1	ExternalPeripherals....................................................................	3-12
3.9	SystemSetting...............................................................................................		3-14
	3.9.1	General SystemSetup................................................................	3-14
	3.9.2	DisplaySetup...............................................................................	3-16
	3.9.3	Misc...............................................................................................	3-18
3.10	MeasureSetting.............................................................................................		3-19
	3.10.1	General.........................................................................................	3-19
	3.10.2	Doppler.........................................................................................	3-20
	3.10.3	Report...........................................................................................	3-21
	3.10.4	OB.................................................................................................	3-22
	3.10.5	FetalEcho....................................................................................	3-25
	3.10.6	Cardiac..........................................................................................	3-26
	3.10.7	Urology..........................................................................................	3-26
	3.10.8	Vascular........................................................................................	3-27
3.11	SettingDICOM(Optional)............................................................................		3-28
	3.11.1	SettingDICOMInformation.........................................................	3-28
	3.11.2	NetworkSetup..............................................................................	3-29
	3.11.3	AddingorChangingtheDICOMServer....................................	3-29
	3.11.4	EditingtheDICOMServer...........................................................	3-32
	3.11.5	DeletingDICOMServer...............................................................	3-32

	3.11.6	TestingDICOMServer................................................................	3-32
	3.11.7	DICOMLog..................................................................................	3-32
3.12	SettingOption.................................................................................................		3-34
3.13	SettingPeripheralDevices............................................................................		3-35
	3.13.1	VideoOutType............................................................................	3-35
	3.13.2	FootSwitch...................................................................................	3-35
	3.13.3	Printer1........................................................................................	3-35
	3.13.4	Printer2........................................................................................	3-35
3.14	Information......................................................................................................		3-36

Contents

Chapter 4. Checking the Product
4.1	Overview	.....................................................................................................	4-1
4.2	StartingtheProduct.......................................................................................		4-2
4.3	Monitor	.......................................................................................................	4-3
	4.3.1	MonitorDisplay............................................................................	4-3
4.4	ControlPanel..................................................................................................		4-5
	4.4.1	DetailControlPanel.....................................................................	4-6
	4.4.2	SoftMenu.....................................................................................	4-8
	4.4.3	Keyboards....................................................................................	4-9
4.5	CheckingthePerformance ..........................................................................		4-11
	4.5.1	BasicCheck.................................................................................	4-11
	4.5.2	DetailCheck.................................................................................	4-12

Contents

5
5.1		5-1
5.2	SystemBlockDiagram..................................................................................		5-3
5.3	EKO7 ........................................................................................		5-4
	5.3.1	...............................................................................................	5-4
	5.3.2	UltrasoundSystemPart..............................................................	5-4
	5.3.3	PCPart.........................................................................................	5-5
	5.3.4	UserInterfacePart.......................................................................	5-5
	5.3.5	ACtoDC PowerModule.............................................................	5-5
5.4	PSA	5-6
5.5	BeamformerBoard.........................................................................................		5-8

5.6CWBoard5-11

5.7

BackEndBoard.............................................................................................

5-14

5.8PCIBoard5-18

5.9DVIBoard5-19

5.10VGACard5-21

5.11	VCRINBoard..................................................................................................	5-22
5.12	PCMotherBoard...........................................................................................	5-23
5.13	SoftwareDSC.................................................................................................	5-24
5.14	LCDIFBoard..................................................................................................	5-26
5.15	RearBoard.....................................................................................................	5-27
5.16	ControlPanel..................................................................................................	5-28
5.17	PowerSupply.................................................................................................	5-30

Contents

Chapter 6. Basic Maintenance
6.1	Overview	.......................................................................................................	6-1
6.2	SystemInformation........................................................................................		6-2
6.3	AdminMode...................................................................................................		6-3
	6.3.1	Entering AdminMode..................................................................	6-3
	6.3.2	AdminModeFunctions................................................................	6-4
6.4	Upgrade	.....................................................................................................	6-6
	6.4.1	SoftwareUpgrade........................................................................	6-6
	6.4.2	HardwareUpgrade......................................................................	6-9
6.5	Backup&Restore..........................................................................................		6-10
	6.5.1	BackupUserSetting....................................................................	6-10
	6.5.2	RestoreUserSetting...................................................................	6-12
6.6	AddingandDeletingOptions.........................................................................		6-14
	6.6.1	Optiontype...................................................................................	6-14
	6.6.2	RegisteringOption.......................................................................	6-14
6.7	ControlPanel..................................................................................................		6-16

Contents

Chapter 7. Troubleshooting
7.1	Overview	.......................................................................................................	7-1
7.2	Power	.......................................................................................................	7-2
	7.2.1	PowerFailure...............................................................................	7-2
	7.2.2	Powercannotturnedoff..............................................................	7-2
	7.2.3	Powerisautomaticallyturnedoff................................................	7-2
7.3	Monitro	.......................................................................................................	7-3
	7.3.1	BlankScreen................................................................................	7-3
	7.3.2	ScreenColorAbnomal................................................................	7-3
7.4	ErrorMessages..............................................................................................		7-4
	7.4.1	Systemhangsafteranerrorduringbooting...............................	7-4
	7.4.2	Systemworkseveniferroroccurred..........................................	7-4
7.5	Image	.......................................................................................................	7-5
	7.5.1 NoBWImageEcho&NoBWModeImageFormat.........................		7-5
	7.5.2 NoiseLinkRainovertheBWModeImage(Noise)...........................		7-5
	7.5.3 PW&ColorDopplerModeTrouble...................................................		7-5

Contents

Chapter 8. Disassembly and Reassembly
8.1	Overview	.......................................................................................................	8-1
8.2	Disassembly and Reassembly of the Body Cover ......................................		8-3
	8.2.1	Preparations.................................................................................	8-3
	8.2.2	BodyRear&MiddleCover.........................................................	8-3
	8.2.3	Disassembly of the Main Part and LCD/Control Panel.............	8-4
8.3	Disassembly and Reassembly of the Main System Part............................		8-5
	8.3.1	Preparations.................................................................................	8-5
	8.3.2	Power&HDD&SideFan...........................................................	8-5
	8.3.3	PSA&Rear&RearFan&Handle.............................................	8-6
	8.3.4	LCD&Inverter&USBBoard......................................................	8-7
8.4	Disassembly and Reassembly of the Control Panel ...................................		8-8
	8.4.1	Preparations.................................................................................	8-8
	8.4.2	Disassembly Control Panel and LCD.........................................	8-8
	8.4.3	ControlPanel................................................................................	8-9

Contents

Chapter 9. Probe
9.1	Overview	.......................................................................................................	9-1
9.2	ProbeList	.......................................................................................................	9-2
9.3	ThermalIndex(TITable)...............................................................................		9-5
9.4	UltrasoundTransmissionGel........................................................................		9-6
9.5	Sheaths	.......................................................................................................	9-7
9.6	ProbePrecautions..........................................................................................		9-9
Chapter 10. User Maintenance
10.1	Overview	.......................................................................................................	10-1
10.2	SystemMaintenance.....................................................................................		10-2
	10.2.1	InstallationMaintenance..............................................................	10-2
	10.2.2	CleaningandDisinfections..........................................................	10-2
	10.2.3	FuseReplacement......................................................................	10-3
	10.2.4	AccuracyCheck...........................................................................	10-4
10.3	AdministrationofInformation.........................................................................		10-5
	10.3.1	UserSettingBack-up...................................................................	10-5
	10.3.2	PatientInformationBack-up........................................................	10-5
	10.3.3	Software........................................................................................	10-5
Chapter 11. Service Part List
11.1	Overview	.......................................................................................................	11-1
11.2	BodyCover.....................................................................................................		11-2
11.3	UltrasoundSystemPart ...............................................................................		11-4
11.4	LCDPart	.......................................................................................................	11-5
11.5	PCPart	.......................................................................................................	11-6
11.6	PowerPart......................................................................................................		11-8
11.7	UserInterfacePart.........................................................................................		11-9
11.8	ETCPart	.................................................................................................	11-10
11.9	Options	...................................................................................................	11-11
11.10	Probes	...................................................................................................	11-12

Chapter 1. General Information

1.1Overview

Chapter 1 contains the information necessary to plan the Troubleshooting of SonoAceR3.

The SonoAceR3 is a high-resolution color ultrasound scanner with high penetration and a variety of measurement functions.

Contents

1.1	Overview	....................................................................................................	1-1
1.2	Features ...............................................and Advantages of SonoAceR3		1-2
1.3	Product Configuration ...............................................................................		1-3
	1.3.1 ....................................................................................	Console	1-3
	1.3.2 ............................................................................	LCD Monitor	1-4
	1.3.3 ...........................................................................	Control Panel	1-5
	1.3.4 ......................................................................................	Probes	1-5
1.4	Specifications.............................................................................................		1-6

Chapter 1. General Information 1-1

1.2Features and Advantages of SonoAceR3

zHigh-end Digital Beamforming : The SonoAceR3 utilizes the newly developed Digital Beam forming technology.

zA variety of applications : The SonoAceR3 is optimized for use in a variety of ultrasound departments, cardiac, vascular, abdomen, Obsterics, Urology, Gynecology.

zVarious diagnostic Modes : 2D Mode, M Mode, Color Doppler Mode, Power Doppler Mode, PW Spectral Doppler Mode, etc.

zMeasurement and Report Functions : Besides the basic distance, area, circumference and volume measurement functions, the SonoAceR3 also provides application-specific measurement functions. The report function collates measurement data.

zReview of Scanned Images : The SonoAceR3 displays Cine images of 512 frames and loop images of 4096 lines.

zSonoViewTM : This is a total ultrasound image management system, which allows a user to archive, view and exchange documents.

zDigital Imaging and Communication in Medicine (DICOM) Function : This is used to archive, transmit and print DICOM images through a network.

zPeripheral/Accessory Connection : A variety of peripheral devices including VCRs and printers can be easily connected to the SonoAceR3.

Chapter 1. General Information 1-2

1.3Product Configuration

This Product consists of the monitor, the control panel, the console and, the probes and the cart(optional).

1.3.2Console

The console consists of two parts – the inner unit and the outer unit.

The interior of the console mainly contains devices that produce ultrasound images. The outside of the console consists of various connection ports and handles.

Handle

LCD Monitor

Control Panel

[Figure 1-1] Console of SonoAce R3

Chapter 1. General Information 1-3

Probe Connector

[Figure 1-2] Front and Back of SonoAce R3

1.3.2LCD Monitor

The monitor of this system is a color VGA monitor, which displays ultrasound images and additional information. This monitor is connected to the main body through a central pivot, allowing it to be tilted to the optimal viewing angle.

[Figure 1-3] LCD Monitor

Chapter 1. General Information 1-4

1.3.3Control Panel

The control panel can be used for controlling the system.

Alpha-Numeric

Button

Dial Button

Track Ball

Slide Volume

[Figure 1-4] Control Panel

1.3.4Probe

Probes are devices that generate ultrasound waves and process reflected wave data for the purpose of image formation.

NOT˙ ˙ ˙E˙

For more information, refer to ‘Chapter 9. Probes’.

Chapter 1. General Information 1-5

1.3.5SonoAceR3 Cart (Optional)

The SonoAce R3 System can be placed on a cart during use or for transport. For more information on installing and using the SonoAce R3, please refer to the installation guide that comes with it.

[Figure 1-5] SonoAce R3 Cart

Chapter 1. General Information 1-6

1.4Specifications

				Height: 375mm (with handle)
	Physical Dimensions			Width: 402mm (with probe holder)
				Depth: 188mm(with control panel)
				Weight: More than 8.7kg
				2D real-time
				Dual 2D real-time
				2D/M-mode
	Imaging modes			Power Doppler
				Color Doppler for Option
				Pulsed-wave Doppler for Option
				3D-mode (Freehand) for Option
				Simultaneous
	Gray Scale			256 (8 bits)
				Dynamic transmit focusing, maximum of eight points (four points
	Focusing			simultaneously selectable)
				Digital dynamic receive focusing (continuous)
				Curved Linear Array : C2-4/20, CN2-8, CN4-9
	Probes			Linear Array : L5-12/60, LN5-12/40
				Endocavity Curved Linear Array : EC4-9
	Probe connections			One probe connectors
				Two probe connectors for option
	Monitor			15 inch LCD monitor
				USB 3ports
				LAN(10/100 BASE-T)
	Rear Panel			DVI Output
	Input/Output			BW Printer remote control
	Connections			BW Output
				S-VHS Output
				Sound Output
				Maximum 512 frames for CINE memory
	Image Storage			Maximum 4096 Lines for LOOP memory
				Image filing system
				Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small
	Application			Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Neonatal,
				Cardiac
	Electrical Parameters			100-120V/200-240V, 250VA, 50/60Hz
				Chapter 1. General Information 1-7

				Obssterics
				Gynecology
	Automatic Calculation			Cardiology
				Fetal Echo
	and Quantification
				Vascular
				Urology
				*Refer the Chapter 5 for additional information
				TGC control
				Mode-independent gain control
				Acoustic power control (adjustable)
	Signal processing			Dynamic aperture
				Dynamic apodization
	(Pre-processing)
				Dynamic range control (adjustable)
				Image view area control
				M-mode sweep speed control
				HD zoom
				Frame average
	Signal processing			Gamma-scale windowing
	(Post-processing)			Image orientation (left/right and up/down, rotation)
				White on black/black on white
				Trackball operation of multiple cursors
				2D mode: Linear measurements and area measurements
	Measurement			using elliptical approximation or trace
				M mode: Continuous readout of distance, time, and slope rate
				Doppler mode: Velocity and trace
				Black-and white printer
				Color printer
	Auxiliary			VCR
				Monitor
				Foot switch
	User Interface			English, German, French, Spanish, Italian, Russian, Chinese
	Pressure Limits			Operating: 700hPa to 1060hPa
				Storage: 700hPa to 1060hPa
	Humidity Limits			Operating: 30% to 75%
				Storage & Shipping: 20% to 90%
	Temperature Limits			Operating: 10 OC ~ 35OC
				Storage & Shipping: -25OC ~ 60OC

Chapter 1. General Information 1-8

Chapter 2. Safety

2.1Overview

Chapter 2 contains the information necessary to Safety

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 R3 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.

Contents

2.1	Overview	....................................................................................................	2-1
2.2	Safety –Related ....................................................................Information		2-2
	2.2.1 .......................................................................	Safety Symbols	2-2
	2.2.2 ......................................................................................	LABEL	2-3
2.3	Electrical .........................................................................................Safety		2-4
	2.3.1 ......................................................	Prevention Electric Shock	2-4
	2.3.2 ..........................................................................................	ESD	2-4
	2.3.3 ...........................................................................................	EMI	2-5
	2.3.4 .........................................................................................	EMC	2-5
2.4	Mechanical ...................................................................................Safety		2-11
	2.4.1 ................................................................	Moving Equipment	2-11
	2.4.2 ............................................................................	Safety Note	2-11
2.5	Biological .....................................................................................Safety		2-12
	2.5.1 ...................................................................	ALARA Principle	2-12
2.6	Environmental .......................................................................Protection		2-24

Chapter 2. Safety 2-1

2.2Safety – Related Information

2.2.1Safety Symbols

The International Electro Technical Commission (IEC) has established a set of

symbols for medical electronic equipment, which classifies a connection or warn of potential hazards. The classifications and symbols are shown below.

Symbols	Description
	Isolated patient connection (Type BF applied part).
	Power switch (Supplies/cuts the power for product).
	Indicates a caution for risk of electric shock.
	Indicates dangerous voltages over 1000V AC or over
	1500V DC.
	Warning, Caution
	AC (alternating current) voltage source
	Print remote output
	Electrostatic discharge
	Network port
	Output port ( DVI, RGB, B/W, S-VHS, SOUND )
	Protection against the effects of immersion.
	Protection against dripping water.
	Probe connector

Chapter 2. Safety 2-2

2.2.2LABEL

To protect the system, you may see ‘Warning’ or ‘Caution’ marked on the surface of the product

[Figure 2-1]Marked on the product

Chapter 2. Safety 2-3

2.3Electrical Safety

This equipment has been verified as a Class I device with Type BF applied parts.

2.3.1Prevention of Electric Shock

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 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 configures 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 abovementioned requirements. If in doubt, consult your local representative or the technical service department.

˙ ˙ ˙ ˙˙˙ ˙

WARNING

zElectric shock may exist result if this system, including and all of its externally mounted recording and monitoring devices, is not properly grounded.

zDo 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.

zCheck the face, housing, and cable before use. Do not use, if the face is cracked, chipped, or torn, the housing is damaged, or if the cable is abraded.

zAlways disconnect the system from the wall outlet prior to cleaning the system.

zAll patient contact devices, such as probes and ECG leads, must be removed from the patient prior to application of a high voltage defibrillation pulse.

zThe use of flammable anesthetic gas or oxidizing gases (N20) should be avoided.

˙ ˙ ˙ ˙˙˙ ˙

CAUTION

zThe system has been designed for 100-120VAC and 200-240VAC; you should select the

inputOutlet voltage of monitor, printer and VCR. Prior to connecting an OEM power cord, verify that the voltage indicated on the power cord matches the voltage rating of the OEM device.

zAn isolation transformer protects the system from power surges. The isolation transformer continues to operate when the system is in standby.

zDo not immerse the cable in liquids. Cables are not waterproof.

zThe operator does not contact the parts (SIP/SOP) and the patient simultaneously.

Chapter 2. Safety 2-4

2.3.2ESD

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, file 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.

˙ ˙ ˙ ˙˙˙ ˙

CAUTION

zThe 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.

zAlways 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.

zIt is highly recommended that the user be given training on ESD-related warning symbols and preventive procedures.

[Figure 2-7] ESD symbol

2.3.3EMI

Although this system has been manufactured in compliance with existing EMI

(Electromagnetic Interference) requirements, use of this system in the presence of an electromagnetic field 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.

Chapter 2. Safety 2-5

2.3.4EMC

The testing for 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).

2.3.4.1Guidance and manufacturer’s declaration - electromagnetic emission

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		Group 1		The Ultrasound System uses RF energy only
	(Radiation)				for its internal function. Therefore, its RF
			Class B
	CISPR 11				emissions are very low and are not likely to
	RF Emission		Group 1		cause any interference in nearby electronic
	(Radiation)				equipment.
			Class B
	CISPR 11				The Ultrasound System is suitable for use in all
	Harmonic Emission		ClassA		establishments, including domestic
	IEC 61000-3-2				establishments and those directly connected to
	Flicker Emission				the public low-voltage power supply network
			Complies		that supplies building used for domestic
	IEC 61000-3-3
					purpose.

2.3.4.2Approved Cables, Transducers and Accessories for EMC

1)Approved Cable for Electromagnetic Compliance

Cables connected to this product may affect 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	2.5m
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

Chapter 2. Safety 2-6

2) Approved Transducer for Electromagnetic Compliance

The probe listed in ‘Chapter 8. Probes’ when used with this product, have been tested to comply with the group1 class B emission as required by International Standard CISPR 11.

3) Approved Accessories for Electromagnetic Compliance

Accessories used with this product may effect 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

˙ ˙ ˙ ˙˙˙ ˙

WARNING

The use of cables, transducers, and accessories other than those specified may result inincreased emission or decreased Immunity of the Ultrasound System.

Immunity test

IEC 60601

Compliance level

Electromagnetic environment -

Test level

guidance

Electrostatic

±6KV Contact

±6KV

Contact

Floors should be wood, concrete

or ceramic tile. If floors are

discharge (ESD)

±8KV

air

±8KV

air

covered with synthetic material,

IEC 61000-4-2

the relative humidity should be at

least 30%.

Electrical fast

±2KV

for power supply

±2KV for power

Mains power quality should be that

of a typical commercial or hospital

transient/burst

lines

supply lines

environment.

±1KV for input/output

±1KV for input/

IEC 61000-4-4

lines

output lines

Surge

±1KV differential mode

±1KV differential mode

Mains power quality should be that

IEC 61000-4-5

±2KV common mode

±2KV common mode

of a typical commercial or hospital

environment.

Voltage dips, short

<5% Uт

<5% Uт

Mains power quality should be that

interruptions and

(>95% dip in Uт)

(>95% dip in Uт)

of a typical commercial or hospital

voltage variations

for 0.5cycle

for 0.5cycle

environment. If the user of this

on power supply

product requires continued

input lines

40% Uт

40% Uт

operation during power mains

(60% dip in Uт )

(60% dip in Uт )

interruptions, it is recommended

IEC 61000-4-11

for 5 cycle

for 5 cycle

that this product be powered from

an uninterruptible power supply or

70% Uт

70% Uт

a battery.

(30% dip in Uт)

(30% dip in Uт)

for 25 cycle

for 25 cycle

<5% Uт

<5% Uт

(<95% dip in Uт )

(<95% dip in Uт )

for 5 s

for 5 s

Chapter 2. Safety 2-7

Power frequency						Power frequency magnetic fields
(50/60Hz)						should be at levels characteristic
magnetic field		3 A/m		3 A/m		of a typical location in a typical
						commercial or hospital
IEC 61000-4-8						environment.
NOTE Uт is the a.c. mains voltage prior to application of the test level.
Conducted RF	3 Vrms		0.01V		Portable and mobile RF communications
IEC 61000-4-6	150 kHz to 80MHz				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
Radiated RF	3 V/m	3 V/m	Where P is the maximum output power rating of
IEC 61000-4-3	80 MHz to 2.5GHz		the transmitter in watts (W) according to the
			transmitter manufacturer and d is the
			recommended separation distance in meters
			(m).
			Field strengths from fixed RF transmitters, as
			deter-mined by an electromagnetic site survey, a
			should be less than the compliance level in
			each frequency range. b
			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 affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 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 effectiveness and filter attenuation.

b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.

Chapter 2. Safety 2-8