Samsung MySono U6 Service manual

Service Manual

WARRANTY

Samsung Medison provides the following warranty to the purchaser of this unit.This warranty is valid for a period of one year from the date of installation and covers all problems caused by faulty workmanship or faulty material. Samsung Medison will, as sole and exclusive remedy and at no charge, replace any such defective unit returned to Samsung Medison within the designated warranty period.

The warranty does not cover damages and loss caused by outside factors including, but not limited to, re,ood, storm, tidal wave, lightning, earthquake, theft, abnormal conditions of operation, and intentional destruction of the equipment. Damage caused by equipment relocation is not covered.

The warranty is void in cases where the equipment has been damaged as a result of an accident, misuse, abuse, dropping, or when attempts to modify or alter any part or assembly of the equipment have taken place.

Parts with cosmetic defects or deterioration will not be replaced. Replacement of batteries, training materials, and supplies are not covered.

Samsung Medison will not be responsible for incidental or consequential damages of any kind arising from or connected with the use of the equipment.

Samsung Medison will not be responsible for any loss, damage, or injury resulting from a delay in services rendered under the warranty

This limited warranty is in lieu of all other warranties expressed or implied, including warranties of merchant ability or tness for any particular use. No representative or other person is authorized to represent or assume for Samsung Medison any warranty liability beyond that set forth herein.

Defective equipment shipped from you to Samsung Medison must be packed in the replacement cartons. Shipping and insurance costs are the responsibility of the customer. To return defective material to Samsung Medison contact the Samsung Medison Customer Service Department.

Samsung Medison or a local distributor will make available, upon request, circuit diagrams, a component parts list, descriptions, calibration instructions and other information which will assist your appropriately quali ed technical personnel to repair those parts of the equipment which are designed by Samsung Medison as repairable.

CAUTION: United State federal law restricts this device to sale by or on the order of physicians.

MANUFACTURER : SAMSUNG MEDISON CO., LTD.

Samsung Medison Bldg., 42, Teheran-ro 108-gil, Gangnam-Gu, Seoul,135-280 Korea

SAMSUNG MEDISON CO., LTD. Customer Service Department

TEL : [phone] FAX : [phone]

Website: www.samsungmedison.com

EC REPRESENTATIVE

SONOACE Deutschland GmbH Elbestrasse 10, 45768 Marl, Germany

TEL : [phone] FAX : [phone]

Service Manual

Version 1.00.00

English

CSD-SMDU6

Safety Classi cations

Classifications:

XXType of protection against electrical shock: Class I

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

XXDegree of protection against harmful ingress of water: Ordinary equipment

XXDegree 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.

XXMode of operation: Continuous operation

Electromechanical safety standards met:

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

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

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

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

XXIEC 61157 Declaration of acoustic output parameters.

XXISO 10993-1 Biological evaluation of medical devices.

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

XXCSA 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 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.

Certificate of Excellent Service Quality is to certify that the above company has served customers with excellent services by the Ministry of Knowledge Economy Republic of Korea.

Before Using This Product

Read this service manual to familiarize yourself thoroughly with repair procedures and important safety information before attempting to service the product.

Failure to follow this information may cause an accident such as electric shock, as well as mechanical or other hazards to the service engineer, product operator, and/or patient.

1.Refer to the service manual when you service the product.

2.You are strongly urged to familiarize yourself with the operational safety information contained in ‘Chapter 2 Safety’.

3.This product is an ultrasound diagnosis device and cannot be used from the user’s PC. We are not responsible for errors that occur when the system is run on the user’s PC.

4.This product may only be serviced by the Global Service Group of Samsung Medison or an authorized engineer.

5.Samsung Medison is not responsible for any problems caused by an unauthorized person servicing the product.

6.The manufacturer is not responsible for any damage to this product caused by user carelessness and/or neglect.

7.The content of this manual may be changed without prior notice.

8.The following terms are used to highlight safety precautions that the user must be aware of:

DANGER: Disregarding this instruction may result in death, serious injury, or other dangerous situations.

WARNING: Follow this information to prevent a serious accident or damage to property.

CAUTION: Hazards or unsafe practices that may result in minor personal injury or property damage.

NOTE: The accompanying information covers an installation, operation, or maintenance procedure that requires careful attention from the user, but has little chance of leading directly to a dangerous situation.

If You Need Help

If you need help regarding the product, please contact the Samsung Medison Global Service Group in charge of servicing this product.

Revision History

The revision history of this manual is as the follows.

Document No.	Date	REASON FOR CHANGE
CSD-SMDU6	2011-12-28	Initial Release

Table of Contents

Table of Contents

Chapter 1 Introduction
1.1	Overview...............................................................................................................................................		1-3
1.2	Main Features of MySono U6........................................................................................................		1-4
1.3	Product Con guration.....................................................................................................................		1-5
	1.3.1	Console............................................................................................................................................................	1-5
	1.3.2	Probes...............................................................................................................................................................	1-6
	1.3.3	Dedicated Cart (Optional) ........................................................................................................................	1-6
1.4	Product Speci cations.....................................................................................................................		1-7

Chapter 2			Safety
2.1	Overview...............................................................................................................................................			2-3
2.2	Safety Information ............................................................................................................................			2-4
	2.2.1	Safety Symbols..............................................................................................................................................		2-4
	2.2.2	Location of Labels........................................................................................................................................		2-5
2.3	Electrical Safety ..................................................................................................................................			2-6
	2.3.1 Prevention of Electric Shock....................................................................................................................			2-6
	2.3.2	ESD ....................................................................................................................................................................		2-7
	2.3.3	EMI......................................................................................................	...............................................................	2-7
	2.3.4	EMC ...................................................................................................................................................................		2-8
2.4	Mechanical Safety ..........................................................................................................................			2-14
	2.4.1	Safety Notes.................................................................................................................................................		2-14
	2.4.2	Moving the Equipment ...........................................................................................................................		2-14
2.5	Biological Safety..............................................................................................................................			2-15
	2.5.1	ALARA Principle..........................................................................................................................................		2-15
2.6	Protecting the Environment.......................................................................................................			2-30
2.7	Battery.................................................................................................................................................			2-31

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Chapter 3			Installing the Product
3.1	Overview...............................................................................................................................................			3-3
3.2	Transporting........................................................................................................................................			3-4
	3.7.1	Caution on Transporting...........................................................................................................................		3-4
	3.7.2	Humidity and Temperature......................................................................................................................		3-4
3.3	Unpacking............................................................................................................................................			3-5
	3.7.3	Dismantling the Product Box ..................................................................................................................		3-5
	3.7.4	Product Components.................................................................................................................................		3-5
	3.7.5	MySono U6 Cart (sold separately) .........................................................................................................		3-6
	3.7.6	MySono U6 Cart (Optional), 2 Probe Connector..............................................................................		3-7
3.4	Installation Environment ................................................................................................................			3-8
	3.7.7	Caution.............................................................................................................................................................		3-8
3.5	Installing the Product.......................................................................................................................			3-9
	3.7.8	Installation Safety ........................................................................................................................................		3-9
	3.7.9	AC Adapter Connection ............................................................................................................................		3-9
	3.7.10	Probe Connection......................................................................................................................................		3-10
3.6	Turning the Product On ..............................................................................................................			3-11
3.7	Shutting Down the Product .......................................................................................................			3-12
3.8	Connecting Peripherals................................................................................................................			3-13
3.9	Connecting the Battery................................................................................................................			3-14
	3.7.11	Battery Icons ................................................................................................................................................		3-15
3.10	System Settings...............................................................................................................................			3-16
	3.7.12	General System Settings (Setup-General)........................................................................................		3-16
	3.7.13	Display ...........................................................................................................................................................		3-19
	3.7.14	Annotate .......................................................................................................................................................		3-23
	3.7.15	Peripherals....................................................................................................................................................		3-25
	3.7.16	User De ned Key........................................................................................................................................		3-27
	3.7.17	Miscellaneous..............................................................................................................................................		3-28
	3.7.18	Option ............................................................................................................................................................		3-29
	3.7.19	DICOM............................................................................................................................................................		3-30
	3.7.20	Auto Calc.......................................................................................................................................................		3-43
	3.7.21	About..............................................................................................................................................................		3-44

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Chapter 4 Inspecting the Product
4.1	Overview...............................................................................................................................................		4-3
4.2	Turning On the Product ..................................................................................................................		4-4
4.3	Monitor..................................................................................................................................................		4-5
	4.3.1	Screen Layout................................................................................................................................................	4-5
	4.3.2	Screen Brightness Adjustment ...............................................................................................................	4-6
4.4	Control Panel.......................................................................................................................................		4-7
	4.4.1 Functions of the Control Panel ...............................................................................................................		4-7
	4.4.2	Alphanumeric Keyboard.........................................................................................................................	4-10
4.5	Inspecting Functions.....................................................................................................................		4-11
	4.5.1	Basic Inspections........................................................................................................................................	4-11
	4.5.2	Detailed Inspections.................................................................................................................................	4-12

Chapter 5		Product Structure
5.1	Overview	...............................................................................................................................................	5-3
5.2	System Block .....................................................................................................................Diagram		5-4
	5.2.1	System ........................................................................................................................................ Overview	5-4
5.3	Basic Structure ......................................................................................................of MySono U6		5-5
	5.3.1	Overview .........................................................................................................................................................	5-5
	5.3.2	Ultrasound ............................................................................................................................. System Part	5-6
	5.3.3	User ........................................................ ............................................................................... Interface Part	5-7
	5.3.4	Miscellaneous ....................................................................................................................................... Part	5-7
5.4	PSA		5-8
	5.4.1	Main ............................................................................................................................................. Functions	5-8
	5.4.2	Speci .................................................................................................................................................. cation	5-8
	5.4.3 ..................................................Operational Principles of the High Voltage Switching Process		5-9
5.5	Main ........................................................................................................................................Board		5-10
	5.5.1 ...........................................................................................................................................	Main Functions	5-10
	5.5.2 ........................................................................................................................................	Beamformer Part	5-11
	5.5.3 ..........................................................................................................................................................	CW Part	5-14
	5.5.4 ...............................................................................................................................................	Back End Part	5-17

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5.6	PCI Part ...............................................................................................................................................		5-21
	5.6.1	Main Functions ...........................................................................................................................................	5-21
5.7	Motor Control Part .........................................................................................................................		5-22
	5.7.1	Main Functions ...........................................................................................................................................	5-22
	5.7.2	Block Diagram.............................................................................................................................................	5-22
	5.7.3	Speci cation ................................................................................................................................................	5-22
	5.7.4	Operational Principles..............................................................................................................................	5-23
5.8	PC Module.........................................................................................................................................		5-24
	5.8.1	Main Functions ...........................................................................................................................................	5-24
5.9	Software DSC ...................................................................................................................................		5-25
	5.9.1	Main Functions ...........................................................................................................................................	5-25
	5.9.2	Operational Principles..............................................................................................................................	5-25
5.10	Control Panel....................................................................................................................................		5-26
	5.10.1	Main Functions ...........................................................................................................................................	5-26
5.11	Power Supply ...................................................................................................................................		5-27
	5.11.1	Power adapter.............................................................................................................................................	5-27
	5.11.2	DC to DC Power Module .........................................................................................................................	5-27

Chapter 6 Basic Maintenance

6.1	Overview...............................................................................................................................................		6-3
6.2	System Information ..........................................................................................................................		6-4
6.3	Windows Mode ..................................................................................................................................		6-5
6.4	Version Updates.................................................................................................................................		6-6
	6.4.1	Software Version Updates ........................................................................................................................	6-6
	6.4.2	Hardware Version Updates.......................................................................................................................	6-6
6.5	Admin Mode........................................................................................................................................		6-7
	6.5.1	Entering Admin Mode................................................................................................................................	6-7
	6.5.2	Admin Mode Functions.............................................................................................................................	6-8
6.6	Adding and Deleting Options ...................................................................................................		6-13
	6.6.1	Types of Option ..........................................................................................................................................	6-13
	6.6.2	Adding an Option......................................................................................................................................	6-14
	6.6.3	Removing an Option ................................................................................................................................	6-17

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Chapter 7			Troubleshooting
7.1	Overview		...............................................................................................................................................	7-3
7.2	Power	.....................................................................................................................................................		7-4
	7.2.1 Power ................................................................................................................................Fails to Turn On			7-4
	7.2.2 Power ...............................................................................................................................Fails to Turn O			7-4
	7.2.3 .............................................................................................................	Power Turns O Spontaneously		7-5
7.3	Monitor..................................................................................................................................................			7-6
	7.3.1 .............................................................................................................Nothing is Displayed on Screen			7-6
	7.3.2 ....................................................................................................................................	Screen is Discolored		7-6
7.4	Error Messages....................................................................................................................................			7-7
	7.4.1 ................................................................................Error Occurs and Product Stops while Booting			7-7
	7.4.2 .............................................................................................................Error Occurs but Product Works			7-7
7.5	Image .....................................................................................................................................................			7-8
	7.5.1 ...............................................................No BW Mode Image Echo; No BW Mode Image Format			7-8
	7.5.2 ................................................................................Rain-like Streaking in BW Mode Image (Noise)			7-8
	7.5.3 .................PW Doppler Mode, CW Doppler Mode, Color Doppler Mode, M Mode Trouble			7-8

Chapter 8			Disassembly and Reassembly
8.1	Overview		...............................................................................................................................................	8-3
8.2	Basic Disassembly and Reassembly ...........................................................................................			8-4
	8.2.1	Preparation.....................................................................................................................................................		8-4
	8.2.2 HDD .....................................................................................................................................& Battery Pack			8-4
	8.2.3 Middle .............................................................................of System Disassembly and Reassembly			8-5
8.3	Ultrasound ......................................................System Part Disassembly and Reassembly			8-7
	8.3.1	Preparation.....................................................................................................................................................		8-7
	8.3.2	MAIN .....................................................................................................................................................ASSY		8-7
	8.3.3 Sub ...........................................................................................Board Disassembly and Reassembly			8-8
8.4	Control Panel ..........................................................................Disassembly and Reassembly			8-9
	8.4.1	Preparation.....................................................................................................................................................		8-9
	8.4.2	Trackball ..........................................................................................................................................................		8-9
	8.4.3	Control ..................................................................................................................................Panel Board		8-10
	8.4.4 Alpha .......................................................................................numeric Keyboard & Speaker ASSY			8-11
8.5	LCD Part Disassembly .................................................................................and Reassembly			8-12
	8.5.1	Preparation...................................................................................................................................................		8-12
	8.5.2	LCD ..................................................................................................................................................Module		8-12

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Chapter 9			Probes
9.1	Overview...............................................................................................................................................			9-3
9.2	Probe List ..............................................................................................................................................			9-4
	9.2.1 Probe Application and Preset..................................................................................................................			9-4
	9.2.2	Function list....................................................................................................................................................		9-5
9.3	Thermal Index (TI) Table..................................................................................................................			9-9
9.4	Ultrasound transmission Gel......................................................................................................			9-10
9.5	Sheaths...............................................................................................................................................			9-11
	9.5.1	Applying Sheath.........................................................................................................................................		9-11
9.6	Probe Safety Precautions.............................................................................................................			9-12
	9.6.1 Use and Infection Control of the Probe.............................................................................................			9-12
	9.6.2	Electric Shocks ............................................................................................................................................		9-13
9.7	Cleaning and Disinfecting the Probe......................................................................................			9-14
	9.7.1 Information on Detergent, Disinfectant, and Ultrasound Gel..................................................			9-14
	9.7.2	Cleaning ........................................................................................................................................................		9-21
	9.7.3	Disinfection ..................................................................................................................................................		9-22

Chapter 10 Maintenance

10.1	Overview............................................................................................................................................		10-3
10.2	Operational Environment............................................................................................................		10-4
	10.2.1 Installing and Storing the Product......................................................................................................		10-4
10.3	Product Maintenance ...................................................................................................................		10-5
	10.3.1	Cleaning ........................................................................................................................................................	10-5
	10.3.2	Disinfection ..................................................................................................................................................	10-6
	10.3.3	Accuracy Check...........................................................................................................................................	10-6
10.4	Battery Pack Management..........................................................................................................		10-7
	10.4.1	Battery Pack Removal...............................................................................................................................	10-7
	10.4.2	Battery Pack Installation..........................................................................................................................	10-7
	10.4.3 Recharging the Battery Pack .................................................................................................................		10-8
	10.4.4 Storing the Battery Pack..........................................................................................................................		10-9
	10.4.5 Disposing of the Battery Pack ...............................................................................................................		10-9

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10.5 Information Maintenance .........................................................................................................		10-10
10.5.1	User Setting Back-up .............................................................................................................................	10-10
10.5.2	Patient Information Restore................................................................................................................	10-10
10.5.3	Software .....................................................................................................................................................	10-11

Chapter 11 Service Part List

11.1	Overview............................................................................................................................................	11-3
11.2	Cover ...................................................................................................................................................	11-4
11.3	System.................................................................................................................................................	11-5
11.4	Control Panel....................................................................................................................................	11-7
11.5	LCD.......................................................................................................................................................	11-8
11.6	Mechanism & Chassis....................................................................................................................	11-9
11.7	Option...............................................................................................................................................	11-10
11.8	Probe .................................................................................................................................................	11-11

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Chapter 1 Introduction

1.1	Overview........................................................		1-3
1.2	Main Features of MySono U6....................		1-4
1.3	Product Configuration................................		1-5
	1.3.1	Console.......................................................................	1-5
	1.3.2	Probes.........................................................................	1-6
	1.3.3	Dedicated Cart (Optional)...................................	1-6
1.4	Product Specifications................................		1-7

Chapter 1 Introduction

1.1 Overview

Chapter 1 describes important information about MySono U6 that you must know before servicing the product. The product’s main features, configuration, and specification are explained.

MySono U6 is a high-resolution, deep-penetration color diagnostic ultrasound system that offers a wide variety of convenient exam options.

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1.2 Main Features of MySono U6

XXCutting-edge Digital Beamforming technology: Utilizes proprietary technology developed by Samsung Medison.

XXDiverse applications: Can be used for such diverse applications as general, obstetrics, gynecology, abdomen, vascular, extremities, cardiac, urology, and chest

XXDiverse diagnosis modes: Features an array of diagnosis modes including 2D mode, M mode, Color Doppler mode (C mode), Power Doppler mode (PD mode), and PW Spectral Doppler mode (D mode).

XX3D image feature: Provides detailed three-dimensional images in 3D and 4D Image modes.

XXMeasurement and report features: In addition to measurements of distance, area, circumference, and volume, various measurement features for each application are provided. A report feature for utilizing the measurements is also provided.

XXScan image review feature: Up to 2621-frame Cine images and 4086-line Loop images are provided.

XXSONOVIEW feature: An integrated image management system facilitates storage and accessing of images and ensures compatibility of data.

XXDigital Imaging and Communication in Medicine (DICOM) feature: Save, transfer, or print images over the network.

XXEase of connecting peripherals: Various peripherals can be connected and used with ease.

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Chapter 1 Introduction

1.3 Product Configuration

MySono U6 consists of the main console, probes, and an optional cart.

1.3.1 Console

The inside of the console contains ultrasound imaging components, and the outside features various connectors and a handle.

[Figure 1.1 MySono U6 Console]

Probe Connector	DVI-I Port	Security
USB Port	LAN Port	MIC Port
	DC Power Port	Audio Port
		USB Port
	[Figure 1.2 MySono U6 Side View]

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1.3.2 Probes

Probes are devices that generate ultrasound waves and then process the reflected wave data to form images.

NOTE: For detailed information, refer to ‘Chapter 9. Probes’.

1.3.3 Dedicated Cart (Optional)

The MySono U6 cart can be used as a base station for your MySono U6, or to move it around. For more information on using and setting up the MySono U6 Cart, refer to the accompanying manual.

[Figure 1.3 MySono U6 Cart]

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Chapter 1 Introduction

1.4 Product Specifications

		Height: 75.4mm
	Physical Dimensions	Width: 360mm
		Depth: 291mm
		Weight: more than 4.8kg (without battery)
		Hight: 23.5mm
	Battery Pack	Width: 224.5mm
		Depth: 78.5mm
		Weight: less than 700g
	Monitor	15 inch LCD monitor
	Probe connections	One probe port
		Two probe ports for option
		Curved Linear Array: C2-5, C2-8, C4-9
		Linear Array: LN5-12
	Probes	Phased Array: P2-4
	(Type BF / IPX7)	Endocavity Curved Linear Array: EVN4-9
		Volume Probe: 3DC2-6, 3D4-9
		CW Probe: CW2.0
	Electrical Parameters	Input: 100-240VAC, 0.7-1.63A, 47-63Hz
		Output: 19VDC, 7.9A, 150W Max
	Pressure Limits	Operating: 700hPa - 1060hPa
		Storage: 700hPa - 1060hPa
	Humidity Limits	Operating: 30% - 75%
		Storage & Shipping: 20% - 90%
	Temperature Limits	Operating: 10°C - 35°C
		Storage & Shipping: -25°C - 60°C
		Video (DVI-I) port
	Input / Output	Network port
		USB port
	Connections
		Microphone port
		Audio port
		USB ECG
		USB Foot Switch(IPX1)
		External DVD Multi
	Auxiliary	USB Video Printer
		USB Laser Printer
		USB Hard Disk Drive
		USB Flash Memory Media
	Application	Abdomen, Obstetrics, Gynecology, Musculoskeletal, Small Parts, Vascular, Cardiac,
		Pediatric Cardiology, TCD, Urology

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		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
	Imaging modes	Tissue Doppler Imaging (TDI) mode
		Tissue Doppler Wave mode
		3D imaging mode
		4D imaging mode
		Dual modes
		Combined modes
		Simultaneous mode
		Zoom mode
		Transmit focusing, maximum of eight points (four points simultaneously
	Focusing	selectable)
		Digital dynamic receive focusing (continuous)
	Gray Scale	256 (8 bits)
		Obstetrics, Gynecology, Cardiac, Carotid, Urology, Fetal Echo, LE Artery, UE Artery,
	Measurement Packages	LE Vein, UE Vein, Radiology, TCD, Thyroid, Breast, Testicle, Superficial, Pediatric
		Hips, MSK
		* Refer to the Chapter 5 for additional information.
		Trackball operation of multiple cursors
		2D mode: Linear measurements and area measurements using elliptical
	Measurement	approximation or trace
		M mode: Continuous readout of distance, time and slope rate
		Doppler mode: Velocity and trace
		Maximum 2,621 frames for CINE memory
	Image Storage	Maximum 8,192 Lines for LOOP memory
		Image filing system
		TGC control
		Mode-independent gain control
		Acoustic power control (adjustable)
	Signal processing	Dynamic aperture
	(Pre-processing)	Dynamic apodization
		Dynamic range control (adjustable)
		Image view area control
		M-mode sweep speed control
		Frame average
		Edge Enhancement / Blurring
	Signal processing	Gamma-scale windowing
	(Post-processing)	Image orientation (left/right and up/down, rotation)
		White on black/black on white
		Zoom

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Chapter 2	Safety

2.1	Overview........................................................		2-3
2.2	Safety Information.......................................		2-4
	2.2.1	Safety Symbols........................................................	2-4
	2.2.2	Location of Labels..................................................	2-5
2.3	Electrical Safety............................................		2-6
	2.3.1 Prevention of Electric Shock...............................		2-6
	2.3.2	ESD...............................................................................	2-7
	2.3.3	EMI................................................................................	2-7
	2.3.4	EMC..............................................................................	2-8
2.4	Mechanical Safety......................................		2-14
	2.4.1	Safety Notes............................................................	2-14
	2.4.2	Moving the Equipment......................................	2-14
2.5	Biological Safety.........................................		2-15
	2.5.1	ALARA Principle.....................................................	2-15
2.6	Protecting the Environment....................		2-30
2.7	Battery..........................................................		2-31

Chapter 2 Safety

2.1 Overview

Chapter 2 contains important information for servicing MySono U6 safely.

It is relevant to the ultrasound system, the probes, the recording devices, and any of the optional equipment.

MySono U6 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.

This equipment should not be used by any healthcare professional or individual who is not properly qualified to operate it. Prolonged use of three-dimensional ultrasound (3D, 4D) by an unqualified individual, such as to produce a commemorative photograph or video of the fetus, may have an adverse effect on the fetus.

Be sure to use the three-dimensional ultrasound diagnostic imaging system only for its intended purposes, since using it for purposes other than diagnosing the fetus may have an adverse effect on the fetus.

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2.2 Safety Information

2.2.1 Safety Symbols

The International Electro Technical Commission (IEC) has established a set of symbols for medical electronic equipment, which classify a connection or warn of potential hazards. The classifications and symbols are shown below.

Symbol

Description

Symbol

Description

DC (direct current) voltage source

Left and right Audio / Video

output

Isolated patient connection (Type

Remote print output

BF applied part)

Power switch (Supplies/cuts the

Foot switch connector

power for product)

Caution: Electric shock risk,

ECG connector

electricity

Indicates dangerous voltages

USB connector

over 1,000V AC or over 1,500V DC.

Danger, warning, caution

MIC input port

Protective grounding terminal

Audio Port

ESD (electrostatic discharge)

Protection against the effects of

warning

immersion

DATA output port

Protection against dripping

water

DATA input port

Probe connector

DATA input/output port

Network port

Left and right Audio / Video input

2-4