Samsung MySono U5 Service manual

SERVICE MANUAL

ENGLISH

MYSONO U5 Service Manual

ENGLISH Document No. CSD-SMEU5 Revision 00

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 Eqiupment, 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;

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).

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 MEDISON Co., Ltd.

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

We are not responsible for errors that occur when the system is run on a user’s PC.

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

useing this system.

Describes precautions necessary to prevent user hazards of great

DANGER

urgency. Ignoring a DANGER warning will risk life-threatening injury.

Used to indicate the presence of a hazard that can cause serious personal

WARNING

CAUTION

NOTE

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.

If You Need Assistance

If you need any assistance with the equipment, please contact the MEDISON

Customer Service Department or one of their worldwide customer service

representatives, immediately.

`````Contents

Chapter 1. General Information 1-1

1.1 Overview 1-1

1.2 Features and Advantages of MySono U5 1-2

1.3 Product Configuration 1-3

1.3.1 Console 1-3

1.3.2 Probes 1-4

1.3.3 MySono U5 Cart(Optional) 1-4

1.4 Specifications 1-5

Chapter 2. Safety 2-1

2.1 Overview 2-1

2.2 Safety – Related Information 2-2

2.2.1 Safety Symbols 2-2

2.2.2 Label 2-4

2.3 Electrical Safety 2-5

2.3.1 Prevention Electric Shock 2-5

2.3.2 ESD 2-6

2.3.3 EMI 2-6

2.3.5 EMC 2-7

2.4 Mechanical Safety 2-13

2.4.1 Safety Note 2-13

2.4.2 Moving the Equipment 2-13

2.5 Biological Safety 2-14

2.5.1 ALARA Principle 2-14

2.6 Environmental Protection 2-24

2.7 Battery Pack 2-25

Contents

Chapter 3. Installing the Product 3-1

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

3.2.3 Transportation of the Product 3-3

3.3 Unpacking 3-4

3.3.1 Unpacking the Box 3-4

3.3.2 Package Contents 3-4

3.3.3 Checking Package Contents 3-4

3.4 Precautions for Installation 3-5

3.4.1 Precautions 3-5

3.4.2 Installation Location 3-5

3.5 Installation Procedure 3-6

3.5.1 Installation Safety 3-6

3.5.2 Connecting the AC Adapter 3-6

3.5.3 Connecting the Probe 3-7

3.6 Starting the Product 3-8

3.7 Shutting down the Product 3-9

3.7.1 Power Switch 3-9

3.8 Connecting the Peripherals 3-10

3.9 Battery Pack 3-11

3.9.1 Battery Icon 3-12

3.10 System Setting 3-13

3.10.1 General System Setup 3-13

3.10.2 Display Setup 3-16

3.10.3 Peripherals Setup 3-18

3.10.4 System Information 3-19

3.10.5 DICOM Setup (Option) 3-20

3.10.6 Utilities Setup 3-30

3.10.7 Option Setup 3-32

3.10.8 Auto Calc 3-33

Contents

Chapter 4. Checking the Product 4-1

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 4-5

4.4.2 Alphanumeric keyboard 4-8

4.5 Checking the Performance 4-10

4.5.1 Basic Check 4-10

4.5.2 Detail Check 4-10

Chapter 5. Product Structure 5-1

5.1 Overview 5-1

5.2 System Block Diagram 5-3

5.3 Basic Structure of MySono U5 5-4

5.3.1 Overview 5-4

5.3.2 Ultrasound System Part 5-4

5.3.3 User Interface Part 5-5

5.3.4 ETC. Part 5-5

5.4 PSA 5-6

5.5 Main Board 5-8

5.6 Back End Part 5-13

5.7 PCI Part 5-16

5.8 Motor Control Panel 5-17

5.9 PC Module 5-18

5.10 Software DSC 5-20

5.11 Control Panel 5-21

5.12 Power Supply 5-22

Contents

5 A

2 7.2

Contents

Chapter 6. Basic Maintenance 6-1

6.1 Overview 6

6.2 S

6.3 Windows Mode 6-3

6.4 Up

6.4.1 Software Up

6.4.2 Hardware Upgrade 6-4

6.5.1 Entering Admin Mode 6

6.5.2 Admin mode Functions 6-6

6.6

6.6.1 Option t

6.6.2 Registering Options 6-12

6.6.

stem Information 6

rade 6-4

dmin Mode 6

dding and Deleting Options 6-11

pe 6-11

Deleting Options 6-1

Chapter 7. Troubleshooting 7-1

7.1 Overview 7-1

7.2.2 Power cannot be turned off 7-2

7.2.

7.3 Monitor 7

7.3.1 Blank Screen 7-3

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 and No BW Mode Format 7-5

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

7.5.4 PW Doppler, Color Doppler and Motion Mode Trouble 7-5

Power 7

.1 Power Failure 7

Power is automatically turned of

Screen Color is Abnormal 7

Contents

Chapter 8. Disassembly and Reassembly 8-1

8.1 Overview 8-1

8.2 Disassembly and Reassembly of a Basis 8-3

8.2.1 Preparations 8-3

8.2.2 HDD and Battery Pack 8-3

8.2.3 Middle of System 8-4

8.3 Disassembly and Reassembly of the Ultrasound System Part 8-6

8.4.1 Preparations 8-6

8.4.2 MAIN ASSY 8-6

8.4.3 Sub Board 8-7

8.4 Disassembly and Reassembly of the Control Panel 8-8

8.4.1 Preparations 8-8

8.4.2 Track Ball 8-8

8.4.3 Control Panel 8-9

8.4.4 Alpha numeric Keyboard and Speaker ASSY 8-10

8.5 Disassembly and Reassembly of the LCD Part 8-11

8.5.1 Preparations 8-11

8.5.2 LCD Module 8-13

Chapter 9. Probe 9-1

9.1 Overview 9-1

9.2 Probe List 9-2

9.3 Thermal Index (TI Table) 9-4

9.4 Ultrasound Transmission Gel 9-5

9.5 Sheaths 9-6

9.6 Probe Precautions 9-7

9.7 Cleaning and Disinfecting the Probe 9-9

Contents

Content

Chapter 10. User Maintenance 10-1

10.1 Overview 10-1

10.2 Operation Environment 10-2

10.2.1 Installation Maintenance 10-2

10.3 System Maintenance 10-2

10.3.1 Cleaning 10-3

10.3.2 Disinfections 10-4

10.4 Battery Pack Maintenance 10-5

10.4.1 Disconnection the Battery Pack 10-5

10.4.2 Connection the Battery Pack 10-5

10.4.3 Charging Battery Pack 10-5

10.4.4 Stroring Battery Pack 10-7

10.4.5 Discarding Battery Pack 10-7

10.5 Administration of Information 10-8

10.5.1 User Setting Back-up 10-8

10.5.2 Patient Information Back-up 10-8

10.5.3 Software 10-8

Chapter 11. Service Part List 11-1

11.1 Overview 11-1

11.2 Cover 11-2

11.3 System 11-4

11.4 Control Panel 11-6

11.5 LCD 11-8

11.6 Mechanism and Chassis 11-9

11.7 Option 11-10

11.8 Probe 11-11

Contents

1 General Information

1.1 Overview

Chapter 1 contains the information necessary to plan the Troubleshooting of MySono U5

1.1 Overview 1-1

1.2 Features and Advantages of MySono U5 1-2

1.3 Product Configuration 1-3

1.3.1 Console 1-3

1.3.2 Probes 1-4

1.3.3 MySono U5 Cart(Optional) 1-4

1.4 Specifications 1-5

The MySono U5 is a high-resolution color ultrasonographic image scanner with deep

penetration which provides a variety of measurement functions.

Contents General Information

Chapter 1. General Information

1-1

1.2 Features and Advantages of MySono U5

y Digital Beamforming : The MySono U5 incorporates Digital Beam Forming, the

advanced proprietary technology provided by MEDISON.

y A variety of applications : The MySono U5 is designed for use in a variety of

ultrasound applications including obstetrics, gynecology, abdominal, vascular,

extremities, cardiac, urology and breast applications.

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

Mode, PW Spectral Doppler Mode.

y 3D imaging : More detailed 3D and 4D image can be acquired.

y Measurement and Reporting – In addition to basic measurements such as distance,

area, circumference and volume, the MySono U5 provides a variety of application-

specific measurement functions. The resulting measurement data can be collated

through its reporting function.

y Review of Scanned Images : The MySono U5 displays Cine images of 2621 frames

and loop images of 4086 lines.

y SonoView

: An integrated ultrasound image management system, which allows

you to archive, view and exchange image data.

y Digital Imaging and Communication in Medicine (DICOM) : A communication

protocol, which allows you to archive, transfer and print images via a network..

y Easy Connection of Peripheral Devices - A variety of peripheral devices can be easily

connected to the MySono U5.

Chapter 1. General Information

1-2

1.3 Product Configuration

This Product consists of the cart(option), the console and the probes.

1.3.1 Console

Whilst the inside of the console consists of devices enabling the implementation of ultrasound images, the outside of the console consists of various connection ports and handles.

LCD Control Panel

[Figure 1-1] Console of MySono U5

Probe Lock Switch

USB Port

[Figure 1-2] Rear and side of MySono U5

DVI-I Port

LAN Port

DC Power Port

Security Lock

MIC Port

Audio Port

USB Port

Chapter 1. General Information

1-3

1.3.2 Probe

Probes are devices that generate ultrasound waves and process reflected wave data

for the purpose of image formation.

NOTE

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

1.3.3 MySono U5 Cart(Optional)

The MySono U5 System can be placed on a cart during use or for transport. For mor information on installing and using the MySono U5 Cart, please refer to the installation

uide that comes with it.

Chapter 1. General Information

1-4

1.4 Specifications

Height: 70mm

Physical Dimensions

Battery Pack

Monitor 15 inch LCD monitor

Probe connections One probe port

Width: 360mm

Depth: 291mm

Weight: more than 5.4kg (without battery)

Hight: 23mm

Width: 214.6mm

Depth: 59mm

Weight: less than 400g

Curved Linear Array : C3-7

Linear Array : L5-12

Probes

Electrical Parameters

Pressure Limits

Humidity Limits

Temperature Limits

Phased Array : P2-4

Endocavity Curved Linear Array : EV4-9

Volume Probe : 3D2-6

Input:100~240VAC, 0.7~1.63A, 47~63Hz

Output:19VDC, 7.9A, 150W Max

Operating: 700hPa to 1060hPa

Storage: 700hPa to 1060hPa

Operating: 30% to 75%

Storage & Shipping: 20% to 90%

Operating: 10OC ~ 35OC

Storage & Shipping: -25OC ~ 60OC

Chapter 1. General Information

1-5

Video (DVI-I) port

Input / Output

Connections

Auxiliary

Application

Imaging modes

Network port

USB port

Microphone port

Audio port

Video (DVI-I) port

Network port

USB port

Microphone port

Audio port

Abdomen, Obstetrics, Gynecology, Musculoskeletal, Small Parts,

Vascular, Cardiac, Pediatric Cardiology, TCD, Urology

2D imaging mode

M imaging mode

Color Doppler Imaging (CDI) mode

Power Doppler Imaging (PDI) mode

Directional Power Doppler Imaging (DPDI) mode

Power Pulse Inversion Imaging (PPII) mode

Pulse Wave (PW) Spectral Doppler imaging mode

Tissue Doppler Imaging (TDI) mode

Tissue Doppler Wave mode

3D imaging mode

4D imaging mode

Dual modes

Combined modes

Simultaneous mode

Zoom

Focusing

Chapter 1. General Information

Transmit focusing, maximum of eight points (four points simultaneously

selectable)

Digital dynamic receive focusing (continuous)

1-6

Gray Scale 256 (8 bits)

Obstetrics, Gynecology, Cardiac, Carotid, Urology, Fetal Echo, LE Artery, UE

Measurement Packages

Measurement

Image Storage

Artery, LE Vein, UE Vein, Radiology, TCD, Thyroid, Breast, Testicle,

Superficial, Pediatric Hips, MSK

* Refer the Chapter 5 for additional information

Obstetrics, Gynecology, Cardiology, Carotid, Fetal Echo, UE Artery,

LE Artery, UE Vein, LE Vein, Radiology, TCD, Thyroid, Breast,

Testicle, Superficial, Pediatric Hips, MSK

* Refer the Chapter 5 for additional information

Maximum 2,621 frames for CINE memory

Maximum 4,086 Lines for LOOP memory

Image filing system

TGC control

Mode-independent gain control

Signal processing

(Pre-processing)

Signal processing

(Post-processing)

Acoustic power control (adjustable)

Dynamic aperture

Dynamic apodization

Dynamic range control (adjustable)

Image view area control M-mode sweep speed control

Frame average

Edge Enhancement / Blurring

Gamma-scale windowing

Image orientation (left/right and up/down, rotation)

White on black/black on white

Zoom

Chapter 1. General Information

1-7

2 Safety

2.1 Overview

Chapter 2 contains the information necessary to Safety

Please read this chapter before using the MEDISON ultrasound system. It relates to the

ultrasound system, the probes, the recording devices, and the optional equipment.

MySono U5 is intended for use by or by the order of, and under the supervision of a

licensed physician who is directly qualified to use 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 2-4

2.3 Electrical Safety 2-5

2.3.1 Prevention Electric Shock 2-5

2.3.2 ESD 2-6

2.3.3 EMI 2-6

2.3.4 EMC 2-7

2.4 Mechanical Safety 2-13

2.4.1 Safety Note 2-13

2.4.2 Moving Equipment 2-13

2.5 Biological Safety 2-14

2.5.1 ALARA Principle 2-14

2.6 Environmental Protection 2-24

2.7 Battery Pack 2-25

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

DC (direct current) voltage source

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.

Isolated patient connection (Type BF applied part).

Power switch (Supplies/cuts the power for product)

Electrostatic discharge

Data Output port

Data Input port

Data Input/Output port

Chapter 2. Safety

2-2

Left and right Audio / Video input

Symbols Description

Left and right Audio / Video output

Print remote output

Foot switch connector

ECG connector

USB connector

Microphone connector

Audio port

Protection against the effects of immersion.

Protection against dripping water.

Probe port

Network port

Chapter 2. Safety

2-3

2.2.2 Labels

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

surface of the product

[Figure 2-1] Marked on the bottom of the product

Chapter 2. Safety

2-4

2.3 Electrical Safety

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

CAUTION

y 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.

y To help assure grounding reliability, connect to a “hospital grade” or “hospital

only” grounded power outlet.

2.3.1 Prevention of Electric Shock

WARNING

y There is a risk of electric shock if the externally mounted recording and

monitoring devices are not properly grounded.

y Never open the product housing cover. There is high voltage power

within the product. All internal adjustments and replacements must be made by the MEDISON Customer Service.

y Always check the product housing, cables, cords, plugs, etc. before use.

Do not use the product if the surface is cracked, chipped, or split, the housing is damaged, or the cable is abraded.

CAUTION

y Always disconnect the system from the wall outlet prior to cleaning the

system.

y All patient contact devices, such as probes, must be removed from the

patient prior to application of a high voltage defibrillation pulse.

y Never use the product in proximity to any flammable anesthetic

gases(N2O) or oxidizing gases. There is a risk of explosion.

y Be sure only to use an AC adaptor that is recommended by MEDISON.

y An isolation transformer protects the system from power surges. The isolation

transformer continues to operate when the system is in standby.

y Do not immerse the cable in liquids. Cables are not waterproof.

y Do not touch SIP/SOP and the patient simultaneously. There is a risk of electric

shock from leakage current.

Chapter 2. Safety

2-5

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 above-mentioned requirements. If in doubt, consult your

local representative or the technical service department.

2.3.2

CAUTION

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.

The ESD caution symbol is on the probe connector and the rear panel.

y 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.

y 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.

y It is highly recommended that the user be given training on ESD-

related warning symbols and preventive procedures.

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, 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.

Chapter 2. Safety

2-6

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.

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.

Chapter 2. Safety

2-7

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

DVI Shielded Normal

USB Shielded Normal

LAN(RJ45) Twisted pair Any

MIC Unshielded Any

Printer Remote Unshielded Any

Audio R.L Shielded Normal

CAUTION

WARNING

2) Probe

The transducers listed in Chapter 9. ‘Probes’ when used with this product,

have been tested to comply with Group 1 Class B emission as required by

International Standard CISPR

3) Approved Accessories for Electromagnetic Compliance

Accessories used with this product may effect its emissions.

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.

Use of unapproved cables, probes or accessories may increase the electromagnetic

emission or decrease the durability of the ultrasound product..

Chapter 2. Safety

2-8

Immunity test

Electrostatic

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

Power frequency (50/60Hz) magnetic field

IEC 61000-4-8

IEC 60601

Test level

±6KV Contact

±8KV air

±2KV for power supply lines

±1KV for input/output lines

±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

3 A/m 3 A/m

Compliance level

±6KV Contact

±8KV air

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

±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

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.

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

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

Chapter 2. Safety

2-9

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

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

2-10

2.3.4.3 Recommended separation distances between portable and mobile RF

communications equipment and the ACCUVIX V20

This product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this product can help Prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter [m]

Rated maximum

output power of

transmitter [W]

0.01 35.00 0.11 0.23

0.1 110.68 0.36 0.73 1 350.00 1.16 2.33

10 1106.80 3.68 7.37

100 3500.00 11.66 23.33

For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in meters (m) can be estimated using the equation applicable to the

frequency of the transmitter, where p is the maximum output power rating of the transmitter

in watts (W) according to the transmitter manufacturer.

NOTE 1) At 80MHz and 800MHz, the separation distance for 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.

150kHz to 80MHz

V1=0.01Vrms E1=3 V/m E1=3V/m

80MHz to 800MHz

800MHz to 2.5GHz

2.3.4.4 Electromagnetic environment – guidance

The Ultrasound System must be used only in a shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location. Field strengths outside the shielded location from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than 3V/m.

It is essential that the actual shielding effectiveness and filter attenuation of the

shielded location be verified to assure that they meet the minimum

specification.

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CAUTION

local area network (LAN) or a remote printer, Medison cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic

If the system is connected to other customer-supplied equipment, such as a

phenomena.

2.3.4.5 Avoiding Electromagnetic Interference

A medical device can either generate or receive electromagnetic interference. The EMC standards describe tests for both emitted and received interference. Medison Ultrasound System does not generate interference in excess of the referenced standards. An Ultrasound System is designed to receive signals at radio frequency and is therefore susceptible to interference generated by RF energy sources. Examples of other source of interference are medical device, information technology products, and radio and television transmission towers. Tracing the source of radiated interference can be a difficult task. Customers should consider the following in an attempt to locate the source:

-Is the interference intermittent or constant?

-Does the interference show up only with one transducers operating at the same frequency or with several transducer?

-Do two different transducer operating at the same frequency have the same problem?

-Is the interference present if the system is moved to a different location in the facility?

The answers to these questions will help determine if the problem reside with the system or the scanning environment. After you answer the question, contact your local MEDISON customer service department.

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