Samsung SonoAce R3 Service manual

ENGLISH Document No. CSD-SMESAR3 Revision 01

SSaaffeettyy RReeqquuiirreemmeennttss

Classifications:

- T ype of protection against electrical shock: Class I

- Degree of protection against electrical shock (Patient connection):T ype BF equipme nt

- 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 sy stems.

- IEC/EN 60601-1-2 Electromagnetic compatibility -Requi rements and te sts.

- IEC/EN 60601-2-37 Particular requirements for the safety of ultrasonic medical

diagnostic and monitoring equipment.

- IEC 61 157 Declaration of acoustic output p arameters.

- 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 Electri cal Equipment, Part 1 General Requirement s for Safety .

Declarations:

0123

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 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.

RREEAADD TTHHIISS FFIIRRSSTT

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.

˙˙˙˙˙˙˙˙˙˙˙

DDAANNGGEER

˙˙˙˙˙˙˙˙˙˙˙˙˙

WWAARRNNIINNG

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

˙˙˙˙˙˙˙

NNOOTTE

Describes precautions necessary to prevent user hazards of great urgency. Ignoring a DANGER warning will risk life-threatening injury.

Used to indicate the presence of a hazard that can cause serious personal injury, or substantial property damage.

Indicates the presence of a hazard that can cause equipment damage.

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 Features and Advantages of SonoAce R3 .................................................. 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 Probe ............................................................................................ 1-5

1.4 Specifications .................................................................................................. 1-6

Chapter 2. Safety

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

Contents

Chapter 3. Installing the Product

3.1 Overview ....................................................................................................... 3-1

3.2 Transportation ................................................................................................ 3-3

3.2.1 Precautions for Transportation .................................................... 3-3

3.2.2 Temperature and Humidity ......................................................... 3-3

3.3 Unpacking ....................................................................................................... 3-4

3.3.1 Unpacking the Box ....................................................................... 3-4

3.3.2 Checking Package contents ....................................................... 3-5

3.4 Precautions for Installation ............................................................................ 3-6

3.4.1 Precautions ................................................................................... 3-6

3.5 Installations Procedure .................................................................................. 3-7

3.5.1 Installation Safety ......................................................................... 3-7

3.5.2 Connecting the Power Cord ........................................................ 3-8

3.5.3 Connecting the Network Cable ................................................... 3-9

3.5.4 Connecting the Probe .................................................................. 3-9

3.6 Starting the Product ....................................................................................... 3-10

3.7 Shutting down the Product ............................................................................ 3-11

3.8 Connecting the Peripherals ........................................................................... 3-12

3.8.1 External Peripherals .................................................................... 3-12

3.9 System Setting ............................................................................................... 3-14

3.9.1 General System Setup ................................................................ 3-14

3.9.2 Display Setup ............................................................................... 3-16

3.9.3 Misc ............................................................................................... 3-18

3.10 Measure Setting ............................................................................................. 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 Fetal Echo .................................................................................... 3-25

3.10.6 Cardiac.......................................................................................... 3-26

3.10.7 Urology.......................................................................................... 3-26

3.10.8 Vascular ........................................................................................ 3-27

3.11 Setting DICOM ( Optional ) ............................................................................ 3-28

3.11.1 Setting DICOM Information ......................................................... 3-28

3.11.2 Network Setup .............................................................................. 3-29

3.11.3 Adding or Changing the DICOM Server .................................... 3-29

3.11.4 Editing the DICOM Server ........................................................... 3-32

3.11.5 Deleting DICOM Server ............................................................... 3 - 3 2

3.11.6 Testing DICOM Server ................................................................ 3-32

3.11.7 DICOM Log .................................................................................. 3-32

3.12 Setting Option ................................................................................................. 3-34

3.13 Setting Peripheral Devices ............................................................................ 3-35

3.13.1 Video Out Type ............................................................................ 3-35

3.13.2 Foot Switch ................................................................................... 3-35

3.13.3 Printer 1 ........................................................................................ 3-35

3.13.4 Printer 2 ........................................................................................ 3-35

3.14 Information ...................................................................................................... 3-36

Contents

Chapter 4. Checking the Product

4.1 Overview ..................................................................................................... 4-1

4.2 Starting the Product ....................................................................................... 4-2

4.3 Monitor ....................................................................................................... 4-3

4.3.1 Monitor Display ............................................................................ 4-3

4.4 Control Panel .................................................................................................. 4-5

4.4.1 Detail Control Panel ..................................................................... 4-6

4.4.2 Soft Menu ..................................................................................... 4-8

4.4.3 Keyboards .................................................................................... 4-9

4.5 Checking the Performance .......................................................................... 4-11

4.5.1 Basic Check ................................................................................. 4-11

4.5.2 Detail Check ................................................................................. 4-12

Contents

제5장 제품 구조

5.1 개요 5-1

5.2 System Block Diagram .................................................................................. 5-3

5.3 EKO7의 기본 구조 ........................................................................................ 5-4

5.3.1 개요 ............................................................................................... 5-4

5.3.2 Ultrasound System Part .............................................................. 5-4

5.3.3 PC Part ......................................................................................... 5-5

5.3.4 User Interface Part ....................................................................... 5-5

5.3.5 AC to DC Power Module ............................................................. 5-5

5.4 PSA 5-6

5.5 Beamformer Board ......................................................................................... 5-8

5.6 CW Board 5-11

5.7 Back End Board ............................................................................................. 5-14

5.8 PCI Board 5-18

5.9 DVI Board 5-19

5.10 VGA Card 5-21

5.11 VCRIN Board .................................................................................................. 5-22

5.12 PC Mother Board ........................................................................................... 5-23

5.13 Software DSC ................................................................................................. 5-24

5.14 LCD IF Board .................................................................................................. 5-26

5.15 Rear Board ..................................................................................................... 5-27

5.16 Control Panel .................................................................................................. 5-28

5.17 Power Supply ................................................................................................. 5-30

Contents

Chapter 6. Basic Maintenance

6.1 Overview ....................................................................................................... 6-1

6.2 System Information ........................................................................................ 6-2

6.3 Admin Mode ................................................................................................... 6-3

6.3.1 Entering Admin Mode .................................................................. 6-3

6.3.2 Admin Mode Functions................................................................ 6-4

6.4 Upgrade . .................................................................................................... 6-6

6.4.1 Software Upgrade ........................................................................ 6-6

6.4.2 Hardware Upgrade ...................................................................... 6-9

6.5 Backup & Restore .......................................................................................... 6-10

6.5.1 Backup User Setting .................................................................... 6-10

6.5.2 Restore User Setting ................................................................... 6-12

6.6 Adding and Deleting Options......................................................................... 6-14

6.6.1 Option type ................................................................................... 6-14

6.6.2 Registering Option ....................................................................... 6-14

6.7 Control Panel .................................................................................................. 6-16

Contents

Chapter 7. Troubleshooting

7.1 Overview ....................................................................................................... 7-1

7.2 Power ....................................................................................................... 7-2

7.2.1 Power Failure ............................................................................... 7-2

7.2.2 Power cannot turned off .............................................................. 7-2

7.2.3 Power is automatically turned off ................................................ 7-2

7.3 Monitro ....................................................................................................... 7-3

7.3.1 Blank Screen ................................................................................ 7-3

7.3.2 Screen Color Abnomal ................................................................ 7-3

7.4 Error Messages .............................................................................................. 7-4

7.4.1 System hangs after an error during booting............................... 7-4

7.4.2 System works even if error occurred .......................................... 7-4

7.5 Image ....................................................................................................... 7-5

7.5.1 No BW Image Echo & No BW Mode Image Format ......................... 7-5

7.5.2 Noise Link Rain over the BW Mode Image (Noise) ........................... 7-5

7.5.3 PW & Color Doppler Mode Trouble ................................................... 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 Body Rear & Middle Cover ......................................................... 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 & Side Fan ........................................................... 8-5

8.3.3 PSA & Rear & Rear Fan & Handle ............................................. 8-6

8.3.4 LCD & Inverter & USB Board ...................................................... 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 Control Panel ................................................................................ 8-9

Contents

Chapter 9. Probe

9.1 Overview ....................................................................................................... 9-1

9.2 Probe List ....................................................................................................... 9-2

9.3 Thermal Index (TI Table) ............................................................................... 9-5

9.4 Ultrasound Transmission Gel ........................................................................ 9-6

9.5 Sheaths ....................................................................................................... 9-7

9.6 Probe Precautions .......................................................................................... 9-9

Chapter 10. User Maintenance

10.1 Overview ....................................................................................................... 10-1

10.2 System Maintenance ..................................................................................... 10-2

10.2.1 Installation Maintenance .............................................................. 10-2

10.2.2 Cleaning and Disinfections .......................................................... 10-2

10.2.3 Fuse Replacement ...................................................................... 10-3

10.2.4 Accuracy Check ........................................................................... 10-4

10.3 Administration of Information ......................................................................... 10-5

10.3.1 User Setting Back-up ................................................................... 10-5

10.3.2 Patient Information Back-up ........................................................ 10-5

10.3.3 Software ........................................................................................ 10-5

Chapter 11. Service Part List

11.1 Overview ....................................................................................................... 11-1

11.2 Body Cover ..................................................................................................... 11-2

11.3 Ultrasound System Part ............................................................................... 11-4

11.4 LCD Part ....................................................................................................... 11-5

11.5 PC Part ....................................................................................................... 11-6

11.6 Power Part ...................................................................................................... 11-8

11.7 User Interface Part ......................................................................................... 11-9

11.8 ETC Part ................................................................................................. 11-10

11.9 Options ................................................................................................... 11-11

11.10 Probes ................................................................................................... 11-12

CChhaapptteerr 11.. GGeenneerraall IInnffoorrmmaattiioonn

1.1 Overview

Chapter 1 contains the informatio n nece ssary to pl an the Tr oubles hooting of SonoAceR3.

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

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

1.2 Features and Advantages of SonoAceR3

z High-end Digital Beamforming : The SonoAce R3 utilize s the ne wly

developed Digital Beam fo rming te chnolo gy.

z A variety of applications : The SonoAceR3 is optimized for use in a variety

of ultrasound departments, cardiac, vascular, abdomen, Obsterics, Urology, Gynecology.

z Various diagnostic Modes : 2D Mode, M Mode, Color Doppler Mode, Power

Doppler Mode, PW Spectral Doppler Mode, etc.

z Measurement 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.

z Review of Scanned Images : The SonoAceR3 displays Cine images of 512

frames and loop images of 4096 lines.

z SonoViewTM : This is a total ultrasound image management system, which

allows a user to archive, view and exchange documents.

z Digital Imaging and Communication in Medicine (DICOM) Function : This is

used to archive, transmit and print DICOM images through a network.

z Peripheral/Accessory Connection : A variety of peripheral devices including

VCRs and printers can be easily connected to the SonoAceR3.

Chapter 1. General Information 1-2

1.3 Product Configuration

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

1.3.2 Console

The console consists of two parts – the in ner 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

[Figure 1-1] Console of SonoAce R3

LCD Monitor

Control Panel

Chapter 1. General Information 1-3

1.3.2 LCD Monitor

The monitor of this system is a colo r VGA monito r, which di splays ultr asound im ages and additional information. This monitor is connected to the main body through a central pivot, allowing it to be tilte d to the optimal vi ewing an gle.

Probe Connector

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

[Figure 1-3] LCD Monitor

Chapter 1. General Information 1-4

1.3.3 Control Panel

The control panel can be used for cont rolling th e system.

Alpha-Numeric

Button

Dial Button

Track Ball

Slide Volume

1.3.4 Probe

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

[Figure 1-4] Control Panel

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NNOOTTE

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

Chapter 1. General Information 1-5

1.3.5 SonoAceR3 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 come s with it.

[Figure 1-5] SonoAce R3 Cart

Chapter 1. General Information 1-6

1.4 Specifications

Height: 375mm (with handle)

Physical Dimensions

Imaging modes

Gray Scale 256 (8 bits)

Focusing

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 Power Doppler Color Doppler for Option Pulsed-wave Doppler for Option 3D-mode (Freehand) for Option Simultaneous

Dynamic transmit focusing, maximum of eight points (four points simultaneously selectable) Digital dynamic receive focusing (continuous)

Curved Linear Array : C2-4/20, CN2-8, CN4-9

Probes

Probe connections

Monitor 15 inch LCD monitor

Rear Panel Input/Output Connections

Image Storage

Application

Linear Array : L5-12/60, LN5-12/4 0 Endocavity Curved Linear Array : EC4-9

One probe connectors Two probe connectors for option

USB 3ports LAN(10/100 BASE-T) DVI Output BW Printer remote control BW Output S-VHS Output Sound Output

Maximum 512 frames for CINE memory Maximum 4096 Lines for LOOP memory Image filing system

Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Neonatal, Cardiac

Electrical Parameters 100-120V/200-240V, 250VA, 50/60Hz

Chapter 1. General Information 1-7

Automatic Calculation and Quantification

Signal processing (Pre-processing)

Signal processing (Post-processing)

Obssterics Gynecology Cardiology Fetal Echo Vascular Urology *Refer the Chapter 5 for additional information

TGC control Mode-independent gain control Acoustic power control (adjustable) Dynamic aperture Dynamic apodization Dynamic range control (adjustable) Image view area control M-mode sweep speed control HD zoom

Frame average Gamma-scale windowing Image orientation (left/right and up/down, rot ation) 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, S panish, Italian, Russian, Chinese

Pressure Limits

Humidity Limits

Temperature Limits

Operating: 700hPa to 1060hPa Storage: 700hPa to 1060h Pa

Operating: 30% to 75% Storage & Shipping: 20% to 90%

Operating: 10 Storage & Shipping: -25

C ~ 35OC

C ~ 60OC

Chapter 1. General Information 1-8

CChhaapptteerr 22.. SSaaffeettyy

2.1 Overview

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

2.2 Safety – Related Information

2.2.1 Safety 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

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

Protection against the effects of immersion.

Protection against dripping water.

Probe connector

Isolated patient connection (Type BF applied part).

Network port

Output port ( DVI, RGB, B/W, S-VHS, SOUND )

Chapter 2. Safety 2-2

2.2.2 LABEL

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

2.3 Electrical Safety

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

2.3.1 Prevention 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.

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WWAARRNNIINNG

z Electric shock may exist result if this system, including and all of its externally mounted

recording and monitoring devices, is not properly grounded.

z Do not remove the covers on the system; hazardous voltages are present inside. Cabinet

panels must be made by a qualified SAMSUNG MEDISON Customer Service Department

z Check 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

z Always disconnect the system from the wall outlet prior to cleaning the system.

z 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

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

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CCAAUUTTIIOON

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

input that the voltage indicated on the power cord matches the voltage rating of the OEM device

z An isolation transformer protects the system from power surges. The isolation transformer continues

to operate when the system is in standby

z Do not immerse the cable in liquids. Cables are not waterproof. z The operator does not contact the parts (SIP/SOP) and the patient simultaneously.

must be in place while the system is in use. All internal adjustments and replacements

Outlet voltage of monitor, printer and VCR. Prior to connecting an OEM power cord, verify

Chapter 2. Safety 2-4

2.3.2 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, 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.

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CCAAUUTTIIOONN

z 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

z 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.

z It is highly recommended that the user be given training on ESD-related warning symbols and

preventive procedures

[Figure 2-7] ESD symbol

2.3.3 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 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.

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CCAAUUTTIIOON

In cases where EMI is causing disturbances, it may be necessary to relocate this

system.

Chapter 2. Safety 2-5

2.3.4 EMC

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).

2.3.4.1 Guidance 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

(Radiation)

CISPR 11

RF Emission

(Radiation)

CISPR 11

Harmonic Emission

IEC 61000-3-2

Flicker Emission

IEC 61000-3-3

Group 1

Class B

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.

2.3.4.2 Approved 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

˙˙˙˙˙˙˙˙˙˙˙˙˙

CCAAUUTTIIOON

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

˙˙˙˙˙˙˙˙˙˙˙˙˙

WWAARRNNIINNG

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

Immunity test

Electrostatic

discharge (ESD)

IEC 61000-4-2

Electrical fast

transient/burst

IEC 61000-4-4

IEC 60601

Test level

±6KV Contact

±8KV air

±2KV for power supply

lines

±1KV for input/output

lines

Compliance level

±6KV Contact

±8KV air

±2KV for power supply lines ±1KV for input/ output lines

Electromagnetic environment -

guidance

Floors should be wood, concrete or ceramic tile. If floors 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.

Surge

IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

±1KV differential mode ±2KV common mode

<5% Uт (>95% dip in Uт)

for 0.5cycle

40% Uт (60% dip in Uт )

for 5 cycle

70% Uт (30% dip in Uт)

for 25 cycle

<5% Uт (<95% dip in Uт )

for 5 s

±1KV differential mode ±2KV common mode

<5% Uт (>95% dip in Uт)

for 0.5cycle

40% Uт (60% dip in Uт )

for 5 cycle

70% Uт (30% dip in Uт)

for 25 cycle

<5% Uт (<95% dip in Uт )

for 5 s

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.

Chapter 2. Safety 2-7

Power frequency (50/60Hz) magnetic field

3 A/m 3 A/m

IEC 61000-4-8

NOTE Uт is the a.c. mains voltage prior to application of the test level.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80MHz

3 V/m

80 MHz to 2.5GHz

0.01V

3 V/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

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 fixed RF transmitters, as deter-mined by an electromagnetic site survey, should be less than the compliance level in each frequency range.

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 [V

] V/m.

Chapter 2. Safety 2-8

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