Mindray M6 User manual

M6 Series

Diagnostic Ultrasound System

Service Manual

Revision 6.0

i

Contents

Contents ..............................................................................................................................................i

Revision History ................................................................................................................................. I

Intellectual Property Statement ......................................................................................................... II

Responsibility on the Manufacturer Party ........................................................................................ III

Warranty ........................................................................................................................................... III

Important Information ....................................................................................................................... IV

1 Safety Precautions .................................................................................................... 1-1

1.1 Meaning of Signal Words ..................................................................................................... 1-1

1.2 Symbols ................................................................................................................................ 1-1

1.2.1 Meaning of Safety Symbols .......................................................................................... 1-1

1.2.2 Warning Labels ............................................................................................................. 1-2

1.2.3 General Symbols .......................................................................................................... 1-2

1.3 Safety Precautions ............................................................................................................... 1-4

1.3.1 Electric Safety ............................................................................................................... 1-4

1.3.2 Mechanical Safety ........................................................................................................ 1-5

1.3.3 Personnel Safety .......................................................................................................... 1-5

1.3.4 Others ........................................................................................................................... 1-5

2 Specifications ........................................................................................................... 2-1

2.1 Overview .............................................................................................................................. 2-1

2.1.1 Intended Use ................................................................................................................ 2-1

2.1.2 Introduction of Each Unit .............................................................................................. 2-1

2.1.3 Extend Modules ............................................................................................................ 2-5

2.1.4 Control Panel .............................................................................................................. 2-10

2.2 Peripherals Supported ....................................................................................................... 2-13

2.3 Specifications ..................................................................................................................... 2-13

2.3.1 External Dimensions and Weight ............................................................................... 2-13

2.3.2 Power supply .............................................................................................................. 2-13

2.3.3 Environmental Conditions ........................................................................................... 2-14

3 System Installation ................................................................................................... 3-1

3.1 Preparations for Installation.................................................................................................. 3-1

3.1.1 Electrical Requirements ................................................................................................ 3-1

3.1.2 Installation Conditions................................................................................................... 3-2

3.1.3 Confirmation before Installation .................................................................................... 3-3

3.2 Unpacking ............................................................................................................................ 3-4

3.2.1 Checking ....................................................................................................................... 3-4

ii

3.3 Installation of Whole Device ................................................................................................. 3-4

3.3.1 Connecting Power Cable .............................................................................................. 3-4

3.3.2 Connecting ECG ........................................................................................................... 3-4

3.3.3 Connecting a Ultrasound Probe ................................................................................... 3-4

3.4 Installing Peripherals ............................................................................................................ 3-4

3.4.1 Connecting the Footswitch ........................................................................................... 3-4

3.4.2 Connecting/ Removing a USB Memory Device ............................................................ 3-5

3.4.3 Graph /Text printer ........................................................................................................ 3-5

3.4.4 Video Printer ................................................................................................................. 3-7

3.4.5 Installing Barcode Reader ............................................................................................ 3-7

3.5 System Configuration ........................................................................................................... 3-8

3.5.1 Power-on Running ........................................................................................................ 3-8

3.5.2 Enter Doppler ................................................................................................................ 3-9

3.5.3 System Preset ............................................................................................................ 3-10

3.5.4 Peripheral Preset ........................................................................................................ 3-11

3.5.5 Network Preset ........................................................................................................... 3-12

3.5.6 DICOM Preset ............................................................................................................ 3-13

3.5.7 System Information Verification .................................................................................. 3-15

4 Product Principle ...................................................................................................... 4-1

4.1 General Structure of Hardware System ............................................................................... 4-1

4.2 Principle of Boards ............................................................................................................... 4-2

4.2.1 Power System ............................................................................................................... 4-2

4.2.2 Principle of the Main Board ........................................................................................ 4-15

4.2.3 Principle of Transmitting Board ................................................................................... 4-37

4.2.4 4D Driving Board ........................................................................................................ 4-42

4.2.5 Principle of Keyboard Board ....................................................................................... 4-46

4.2.6 Display Unit ................................................................................................................. 4-54

4.2.7 Principle of ECG Board .............................................................................................. 4-58

4.2.8 Principle of Video/Audio Capture Card ....................................................................... 4-61

4.2.9 Principle of the CW Board .......................................................................................... 4-62

5 Checking Performance and Functions .................................................................... 5-1

5.1 Description ........................................................................................................................... 5-1

5.2 Checking System Status ...................................................................................................... 5-1

5.2.1 Running Status ............................................................................................................. 5-1

5.2.2 Working Condition ........................................................................................................ 5-1

5.3 General Check ..................................................................................................................... 5-2

5.3.1 Check Flow ................................................................................................................... 5-2

5.3.2 Check Content .............................................................................................................. 5-2

iii

5.4 Functions Checking .............................................................................................................. 5-4

5.4.1 Checking Flow .............................................................................................................. 5-4

5.4.2 Content ......................................................................................................................... 5-5

5.5 Performance Test ............................................................................................................... 5-11

5.5.1 Test Procedures .......................................................................................................... 5-11

5.5.2 Test Content ................................................................................................................ 5-12

6 Software Installation & Maintenance ....................................................................... 6-1

6.1 Enter Maintenance ............................................................................................................... 6-1

6.2 Software Upgrade ................................................................................................................ 6-2

6.3 Log Export ............................................................................................................................ 6-2

6.4 Data Management ................................................................................................................ 6-2

6.4.1 Preset Data Management ............................................................................................. 6-2

6.4.2 Patient Data Backup and Restoration .......................................................................... 6-3

6.5 Introduction on HDD Partition Data ...................................................................................... 6-4

7 Structure and Assembly/Disassembly .................................................................... 7-1

7.1 Explosive Figure of the Structure ......................................................................................... 7-1

7.1.1 Explosive Figure of the Complete System ................................................................... 7-1

7.1.2 Explosive Figure of the Modules .................................................................................. 7-3

7.2 Field Replaceable Unit ......................................................................................................... 7-6

7.3 Assembly/Disassembly ...................................................................................................... 7-21

7.3.1 Removing Batteries .................................................................................................... 7-21

7.3.2 Removing Monitor Assembly ...................................................................................... 7-21

7.3.3 Removing Top Cover of Main Unit .............................................................................. 7-26

7.3.4 Removing the Power Module ..................................................................................... 7-29

7.3.5 Removing CW Board and Installation ......................................................................... 7-30

7.3.6 Removing CPU Fan .................................................................................................... 7-31

7.3.7 Removing CPU Board and Radiator Module .............................................................. 7-32

7.3.8 Removing the System Fan ......................................................................................... 7-33

7.3.9 Remove the Speakers ................................................................................................ 7-34

7.3.10 Removing Transmission Board ................................................................................... 7-35

7.3.11 Removing Main Board and Transducer Board Assembly ........................................... 7-36

7.3.12 Remove the Transducer Board ................................................................................... 7-38

7.3.13 Removing 4D Board and Installation .......................................................................... 7-39

7.3.14 Removing Hard Disk ................................................................................................... 7-41

8 Installation of Option Modules ................................................................................. 8-1

8.1 Installation of Optional Devices to Software ......................................................................... 8-1

8.2 Installation of the Accessory Kits and Optional Devices to Hardware ................................. 8-2

9 System Diagnosis and Support ............................................................................... 9-1

iv

9.1 Warning ................................................................................................................................ 9-1

9.1.1 Battery warning ............................................................................................................. 9-1

9.1.2 PHV Exception Warning Verification ............................................................................ 9-4

9.1.3 Fan Warning ................................................................................................................. 9-5

9.1.4 Temperature Warning ................................................................................................... 9-5

9.1.5 Volt Warning.................................................................................................................. 9-6

9.2 System Self-diagnosis .......................................................................................................... 9-6

9.2.1 Screen Introduction ...................................................................................................... 9-6

9.2.2 Region of Self-diagnosis Items and Testing Results .................................................... 9-9

9.2.3 Description of Self-diagnosis Test Items ..................................................................... 9-13

10 Care and Maintenance ............................................................................................ 10-1

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

10.1.1 Tools, Measurement Devices and Consumables ....................................................... 10-1

10.1.2 Care and Maintenance Items ..................................................................................... 10-2

10.2 Cleaning ............................................................................................................................. 10-3

10.2.1 Clean the System ....................................................................................................... 10-3

10.2.2 Content ....................................................................................................................... 10-3

10.2.3 Clean the Peripherals ................................................................................................. 10-6

10.3 Checking ............................................................................................................................ 10-6

10.3.1 General check ............................................................................................................. 10-6

10.3.2 System Function Check .............................................................................................. 10-7

10.3.3 Peripherals and Options Check .................................................................................. 10-7

10.3.4 Mechanical Safety Inspection ..................................................................................... 10-8

10.3.5 Electrical Safety Inspection ........................................................................................ 10-9

11 Troubleshooting of Regular Malfunctions ............................................................. 11-1

11.1 Inspection and Repair Work Flow of Power System Failure .............................................. 11-1

11.1.1 Inspection and Repair Work Flow When Powered by Adapter ................................... 11-1

11.1.2 Inspection and Repair Work Flow When Powered by Batteries ................................. 11-2

11.1.3 Inspection and Repair Work Flow of the Charging Unit of the Power System ........... 11-3

11.2 Location and Repair of System Boot Failure Malfunctions ................................................ 11-4

11.3 Location and Repair of Non-echo Failure in Image Region ............................................... 11-8

11.4 Location and Repair of the Problem of Image with Black Area ........................................ 11-10

11.5 Abnormalities in Image Region ........................................................................................ 11-10

11.6 Inspection and Repair Work Flow of USB Port Failure ..................................................... 11-11

11.7 Inspection and Repair Work Flow of Network Failure ...................................................... 11-12

11.8 Troubleshooting for 4D Board .......................................................................................... 11-13

11.9 Troubleshooting for the Keyboard Board ......................................................................... 11-14

11.10 Troubleshooting for ECG Board ....................................................................................... 11-15

v

11.11 Troubleshooting for Video & Audio Capture Card ............................................................ 11-17

Appendix A Electrical Safety Inspection .................................................................A-1

Appendix B Phantom Usage Illustration .................................................................B-1

I

Revision History

Mindray may revise this publication from time to time without written notice.

Revision

Date

Reason for Change

1.0

2016-7-13

Initial

2.0

2016-9-28

Add FRU number of M5 HDD and Display assembly in 7.2 chapter

3.0

2017-6

Add baytrail PC module and compatible HDD FRU number in 7.2

chapter.

4.0

2017-12

Add HDD FDA BayTrail PC module FRU number in 7.2 chaper.

5.0

2019-6

Delete Button Battery, modify FRU number and comments of M6

keyboard top cover assembly, Silicon Keypad, Large/Small

encoder knob, Large/Small encoder button, M5 Exp Main Unit

Cover in 7.2 chapter.

Add wireless USB adapter in 7.2 chapter.

Change barcode model DS6707 to DS4308

6.0

2019-10

Delete CPU module(with Radisys PC module), modify FRU

number and comments of Power module

II

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)

owns the intellectual property rights to this Mindray product and this manual. This manual may refer

to information protected by copyright or patents and does not convey any license under the patent

rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure of

the information in this manual in any manner whatsoever without the written permission of Mindray

is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

derivative work of this manual in any manner whatsoever without the written permission of Mindray

is strictly forbidden.

, , , , BeneView, WATO, BeneHeart,

are the trademarks, registered or otherwise, of Mindray in China and other countries. All other

trademarks that appear in this manual are used only for informational or editorial purposes. They

are the property of their respective owners.

III

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable for

errors contained herein or for incidental or consequential damages in connection with the furnishing,

performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product, only if:

 all installation operations, expansions, changes, modifications and repairs of this product

are conducted by Mindray authorized personnel;

 the electrical installation of the relevant room complies with the applicable national and

local requirements; and

 the product is used in accordance with the instructions for use.

Note

This equipment must be operated by skilled/trained clinical professionals.

Warning

It is important for the hospital or organization that employs this equipment to carry out a reasonable

service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED

OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY

PARTICULAR PURPOSE.

Exemptions

Mindray's obligation or liability under this warranty does not include any transportation or other

charges or liability for direct, indirect or consequential damages or delay resulting from the improper

use or application of the product or the use of parts or accessories not approved by Mindray or

repairs by people other than Mindray authorized personnel.

IV

This warranty shall not extend to:

 Malfunction or damage caused by improper use or man-made failure.

 Malfunction or damage caused by unstable or out-of-range power input.

 Malfunction or damage caused by force majeure such as fire and earthquake.

 Malfunction or damage caused by improper operation or repair by unqualified or unauthorized

service people.

 Malfunction of the instrument or part whose serial number is not legible enough.

 Others not caused by instrument or part itself.

Company Contact

Manufacturer:

Shenzhen Mindray Bio-medical Electronics Co., Ltd.

E-mail Address:

service@mindray.com.cn

Tel:

+86 755 26582479 26582888

Fax:

+86 755 26582934 26582500

EC-Representative:

Shanghai International Holding Corp. GmbH(Europe)

Address:

Eiffestraβe 80, Hamburg 20537, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

Important Information

1. It is the customer’s responsibility to maintain and manage the system after delivery.

2. The warranty does not cover the following items, even during the warranty period:

(1) Damage or loss due to misuse or abuse.

(2) Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc.

(3) Damage or loss caused by failure to meet the specified conditions for this system, such as

inadequate power supply, improper installation or environmental conditions.

(4) Damage or loss due to use of the system outside the region where the system was

originally sold.

(5) Damage or loss involving the system purchased from a source other than Mindray or its

authorized agents.

V

3. This system shall not be used by persons other than fully qualified and certified medical

personnel.

4. DO NOT make changes or modifications to the software or hardware of this system.

5. In no event shall Mindray be liable for problems, damage, or loss caused by relocation,

modification, or repair performed by personnel other than those designated by Mindray.

6. The purpose of this system is to provide physicians with data for clinical diagnosis. It is the

physician’s responsibility for diagnostic procedures. Mindray shall not be liable for the results of

diagnostic procedures.

7. Important data must be backed up on external memory media.

8. Mindray shall not be liable for loss of data stored in the memory of this system caused by

operator error or accidents.

9. This manual contains warnings regarding foreseeable potential dangers, but you shall always

be alert to dangers other than those indicated as well. Mindray shall not be liable for damage or

loss that results from negligence or from ignoring the precautions and operating instructions

described in this operator’s manual.

10. If the manager for this system is changed, be sure to hand over this operator’s manual to the

new manager.

1-1

1 Safety Precautions

1.1 Meaning of Signal Words

In this manual, the signal words “ DANGER”, “ WARNING”, “ CAUTION”,

“NOTE” are used regarding safety and other important instructions. The signal words and their

meanings are defined as follows. Please understand their meanings clearly before reading this

manual.

Signal Word

Meaning

DANGER

Indicates an imminently hazardous situation that, if not avoided, will

result in death or serious injury.

WARNING

Indicates a potentially hazardous situation that, if not avoided, could

result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation that, if not avoided, may

result in minor or moderate injury.

NOTE

Indicates a potentially hazardous situation that, if not avoided, may result in

property damage.

1.2 Symbols

1.2.1 Meaning of Safety Symbols

Symbol

Description

Type-BF applied part.

The ultrasound probes connected to this system are type-BF applied parts.

The ECG leads applied on this system are type-BF applied parts, too.

“Attention” indicates the points that you should pay attention to. Be sure to

read the operator’s manual concerning these points before using the system.

1-2

1.2.2 Warning Labels

The warning labels are attached to this system in order to call your attention to potential hazards.

The warning labels use the same signal words as those used in the operator’s manual. Read

operator’s manual carefully before using the system.

The name, pattern and meaning of each warning label are described as follows:

No.

Warning Labels

Meaning

1

Read this information carefully before using the

system.

2

The following labels are available

when the system works with the

mobile trolley.

a. Do not place the system on a sloped surface.

Otherwise the system may slide, resulting in

personal injury or the system malfunction. Two

persons are required to move the system over a

sloped surface.

b. Do not sit on the system.

c. DO NOT push the system when the casters

are locked.

1.2.3 General Symbols

This system uses the symbols listed in the following table, and their meanings are explained as

well.

Symbol

Description

Type-BF applied part

Caution

AC (Alternating current)

Battery Status Indicator

Power button

Probe port

Probe connection unlocked symbol

Probe connection locked symbol

1-3

Symbol

Description

I/O extend port

12V 9A (Max.)

USB port

Network port

S-VIDEO signal interface;

VIDEO signal interface

Pencil probe port (reserved)

Battery installation position indicator

ECG function

No user serviceable parts (applied to the power adapter)

Indoor, dry location use only (applied to the power adapter)

Connects serial port devices

ECG function

Connects a display or projector

Audio signal

Microphone input jack

Remote control port

Product serial number

Manufacture date

Authorized representative in the European Community

This product is provided with a CE marking in accordance with the regulations

stated in Council Directive 93 / 42 / EEC concerning Medical Devices. The

number adjacent to the CE marking (0123) is the number of the EU-notified body

certified for meeting the requirements of the Directive.

The radio device used in this product is in compliance with the essential

requirements and other relevant provisions of Directive 1999/5/EC (Radio

Equipment and Telecommunications Terminal Equipment Directive). The

product is in compliance with ETSI EN 300 328 and ETSI EN 301 489.

NOTE: The product complies with the Council Directive 2011/65/EU.

1-4

1.3 Safety Precautions

Please read the following precautions carefully to ensure the safety of the patient and the operator

when using the probes.

DANGER:

Do not operate this system in an atmosphere containing flammable

or explosive gases such as anesthetic gases, oxygen, and hydrogen

or explosive fluid such as ethanol because an explosion may occur.

1.3.1 Electric Safety

WARNING:

1.

Connect the power plug of this system and power plugs of the

peripherals to wall receptacles that meet the ratings indicated

on the rating nameplate. Using a multifunctional receptacle may

affect the system grounding performance, and cause the

leakage current to exceed safety requirements. Use the power

cord accompanied with the system provided by Mindray.

2.

Disconnect the AC power before you clean or uninstall the

ultrasound machine, otherwise, electric shock may result.

3.

When using peripherals not powered by the auxiliary output of the

ultrasound system, or using peripherals other than permitted by

Mindray, make sure the overall leakage current of peripherals and

the ultrasound system meets the requirement of the local medical

device electrical regulation (like enclosure leakage current should

be no more than 500uA of IEC 60601-1-1), and the responsibility is

held by the user.

4.

In maintenance or assembly/disassembly, make sure other

cables are connected well before the battery connecting cable is

connected, otherwise the system may be damaged due to

hot-plug.

5.

Do not use this system simultaneously with equipment such as

an electrosurgical unit, high-frequency therapy equipment, or a

defibrillator, etc.; otherwise electric shock may result.

6.

This system is not water-proof. If any water is sprayed on or into

the system, electric shock may result.

CAUTION:

1.

DO NOT connect or disconnect the system’s power cord or its

accessories (e.g., a printer or a recorder) without turning OFF

the power first. This may damage the system and its

accessories or cause electric shock.

2.

Avoid electromagnetic radiation when perform performance test

on the ultrasound system.

3.

In an electrostatic sensitive environment, don’t touch the device

directly. Please wear electrostatic protecting gloves if

necessary.

1-5

4.

You should use the ECG leads provided with the ECG module.

Otherwise it may result in electric shock. Maximum output

power of the trolley is 240 VA.

1.3.2 Mechanical Safety

WARNING:

1.

When moving the system, you should first power off the system, fold

the LCD display, disconnect the system from other devices (including

probes) and disconnect the system from the power supply.

2.

Do not subject the transducers to knocks or drops. Use of a defective

probe may cause electric shock to the patient.

CAUTION:

1.

Do not expose the system to excessive vibration (during the

transportation) to avoid device dropping, collision, or mechanical

damage.

2.

When you place the system on the mobile trolley and move them

together, you must secure all objects on the mobile trolley to

prevent them from falling. Otherwise you should separate the

system from the mobile trolley and move them individually. When

you have to move the system with the mobile trolley upward or

downward the stairs, you must separate them first and then move

them individually.

3.

Do not move the ultrasound system if the HDD indicator is green,

sudden shake may cause the HDD in damage.4 When moving the

trolley with mounted system, please take care of the connector of

the power adapter in case of damage.

1.3.3 Personnel Safety

NOTE:

1.

The user is not allowed to open the covers and panel of the system, neither

device disassemble is allowed.

2.

To ensure the system performance and safety, only Mindray engineers or

engineers authorized by Mindray can perform maintenance.

3.

Only technical professionals from Mindray or engineers authorized by Mindray

after training can perform maintenance.

1.3.4 Others

NOTE:

For detailed operation and other information about the ultrasound system, please refer

to the operator’s manual.

2-1

2 Specifications

2.1 Overview

2.1.1 Intended Use

The diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and

neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast,

testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral

vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams,

intraoperative and transesophageal (cardiac).

2.1.2 Introduction of Each Unit

2.1.2.1 Main Unit

No.

Name

Function

1

Monitor

Displays the images and parameters during scanning.

2

Control Panel

Operator-system interface or control.

3

CW pencil probe port

Connects the pencil probe to the main unit

4

Handle

Used for carrying the system.

5

Probe port

Connects a probe to the main unit; or connects a probe

extend module.

2-2

No.

Name

Function

6

Transducer locking lever

Locks or unlocks the probe connected with the main unit.

: locked symbol

: unlocked symbol

7

I/O extend port

Connects the I/O extend module.

8

Power input port

Connects the power adapter.

9

USB port

Connects USB devices.

10

Network port

Connects the network.

11

S-Video separate video

output

Connects DVR recorder or video printer.

2.1.2.2 Mobile trolley

The system can be configured with 2 models of mobile trolley: UMT-200 and UMT-300.

Mobile Trolley is used for placing the ultrasound system, extend modules and etc.

UMT-200

2-3

UMT-300

WARNING:

1.

Be sure to connect the equipotential wire before inserting the

power plug into the receptacle; be sure to remove the power plug

from the receptacle before disconnecting the equipotential wire;

otherwise electric shock may result.

2.

When you connect another device to the trolley, you should use

the equipotential wire to connect each of equipotential terminals;

otherwise electric shock may result.

3.

Connect the earth cable before powering ON. Disconnect the

earth cable after powering OFF. Otherwise, electric shock may

result.

4.

DO NOT connect the trolley to the outlets with the same circuit

breakers and fuses that control the current to devices such as

life-support systems. If the trolley or the system malfunctions and

generates over-current, or when there is an instantaneous current

at power ON, the circuit breakers and fuses of the building’s

supply circuit may be tripped.

5.

If UMT-300 has configured with display module, please take care

of the display module position to leave enough space below when

adjusting the display support arm, so that the display module will

not hit into the monitor of the ultrasound system.

CAUTION:

1.

When moving the trolley with mounted system, please take care of

the connector of the power adapter in case of damage.

2.

Maximum output power of the outlet in the trolley is 350VA.

NOTE

1.

If UMT-300 has configured with display module, please take care of the display

module position in case of hurting one’s head.

2.

If probe extend module is configured, please do not place any objects under the

module.

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