Mindray TE Air Service Manual User manual

Diagnostic Ultrasound System

Service Manual

Version 1.0

P/N: 046-027347-00

ii

Table of Contents

1 Preface..............................................................................................................................................7

1.1 Revision History ............................................................................................................................... 7

1.2 Descriptions Committed ................................................................................................................. 7

1.3 Service Contact................................................................................................................................ 9

1.4 Intellectual Property Statement ................................................................................................... 10

1.5 Statement........................................................................................................................................ 11

1.6 Applicability..................................................................................................................................... 12

1.7 Responsibility on the Manufacturer Party .................................................................................. 13

1.8 Safety .............................................................................................................................................. 14

2 Product Knowledge................................................................................................................ 21

2.1 Introduction..................................................................................................................................... 21

2.1.1 Intended Use.................................................................................................................................. 21

2.1.2 System Appearance ...................................................................................................................... 21

2.2 Specifications ................................................................................................................................. 22

2.2.1 Physical Specifications .................................................................................................................. 22

2.2.2 Electrical Specifications ................................................................................................................. 22

2.2.3 Environmental Specifications ........................................................................................................ 22

2.3 Product Principle............................................................................................................................ 23

2.3.1 Overall Architecture of Hardware System ..................................................................................... 23

2.3.1.1 Hardware System Diagram ............................................................................................................23

2.3.2 Main control module....................................................................................................................... 24

2.3.2.1 Front-end TX and RX Modules.......................................................................................................24

2.3.2.2 WLAN Module ...............................................................................................................................24

2.3.2.3 FPGA Module ................................................................................................................................24

2.3.3 Power supply module..................................................................................................................... 24

2.3.3.1 Charging Port and Circuit ...............................................................................................................24

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2.3.3.2 Battery Management Module .........................................................................................................27

2.3.3.3 DC-DC Module ..............................................................................................................................28

2.3.3.4 PHV Module ..................................................................................................................................28

2.3.4 UI Unit ............................................................................................................................................ 28

2.3.4.1 Keys and LED Indicators................................................................................................................28

2.4 Probes and Needle Guides .......................................................................................................... 29

2.4.1 Probes............................................................................................................................................ 29

3 How to Use .................................................................................................................................. 30

3.1 Device Requirements.................................................................................................................... 30

3.1.1 Minimum Configuration for System Operation .............................................................................. 30

3.1.2 Downloading and Installing the App .............................................................................................. 30

3.2 Unpacking....................................................................................................................................... 30

3.2.1 Packing Box ................................................................................................................................... 30

3.3 Getting Started ............................................................................................................................... 33

3.3.1 Starting the App ............................................................................................................................. 33

3.3.2 Connecting the Probe .................................................................................................................... 33

3.3.3 System setup ................................................................................................................................. 39

3.3.3.1 Image ............................................................................................................................................39

3.3.3.2 Probe Setup...................................................................................................................................39

3.3.3.3 DICOM Server Settings..................................................................................................................40

3.3.3.4 Worklist..........................................................................................................................................41

3.3.3.5 My Account....................................................................................................................................41

3.3.3.6 Network Setup ...............................................................................................................................42

3.3.4 Charging......................................................................................................................................... 43

3.3.4.1 Using an Power Outlet to Charge the Wireless Probe.....................................................................43

3.3.4.2 Using the Charging Station to Charge the Wireless Probe ..............................................................43

3.3.4.3 Using the Charging Case (Air Capsule) to Charge the Wireless Probe............................................43

4 Function and Performance Check ................................................................................. 45

4.1 Description...................................................................................................................................... 45

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4.1.1 Description ..................................................................................................................................... 45

4.2 Routine Check................................................................................................................................ 45

4.2.1 Routine Check ............................................................................................................................... 45

4.3 Function Check .............................................................................................................................. 45

4.3.1 Function Check .............................................................................................................................. 45

4.4 Performance test ........................................................................................................................... 46

4.4.1 Test Process .................................................................................................................................. 46

4.4.1.1 Test Process ..................................................................................................................................46

4.4.2 Test Items....................................................................................................................................... 46

4.4.2.1 Lateral Resolution..........................................................................................................................46

4.4.2.2 Axial Resolution .............................................................................................................................47

4.4.2.3 Maximum Detection Depth.............................................................................................................48

4.4.2.4 Axial Geometric Positioning Accuracy ............................................................................................49

4.4.2.5 Lateral Geometric Positioning Accuracy .........................................................................................50

4.4.2.6 Dead Zone.....................................................................................................................................51

5 Maintenance ............................................................................................................................... 53

5.1 Overview ......................................................................................................................................... 53

5.1.1 Description ..................................................................................................................................... 53

5.1.2 Tools, Measurement Devices and Consumables .......................................................................... 53

5.1.3 Routine Maintenance Items ........................................................................................................... 54

5.2 System Cleaning............................................................................................................................ 54

5.2.1 Cleaning the Probe ........................................................................................................................ 54

5.3 Inspection........................................................................................................................................ 56

5.3.1 General Inspections ....................................................................................................................... 56

5.3.2 System Function Inspection........................................................................................................... 56

5.3.3 Inspection of Peripherals and Optional Functions......................................................................... 57

5.3.4 Electrical Safety Inspection............................................................................................................ 57

6 FRU Replacement.................................................................................................................... 58

6.1 i3P ultrasound probe (FDA) ......................................................................................................... 58

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6.1.1 General Information ....................................................................................................................... 58

6.1.2 Disassembly and Assembly........................................................................................................... 58

6.1.3 Commissioning and Verification .................................................................................................... 58

6.2 Wireless Probe Adapter Cable .................................................................................................... 59

6.2.1 General Information ....................................................................................................................... 59

6.2.2 Disassembly and Assembly........................................................................................................... 59

6.2.3 Commissioning and Verification .................................................................................................... 59

6.3 Wireless Probe Charging Case (FDA)........................................................................................ 60

6.3.1 General Information ....................................................................................................................... 60

6.3.2 Disassembly and Assembly........................................................................................................... 60

6.3.3 Commissioning and Verification .................................................................................................... 60

7 Troubleshooting....................................................................................................................... 61

7.1 System Diagnosis and Support ................................................................................................... 61

7.1.1 Self-test .......................................................................................................................................... 61

7.1.2 Monitoring ...................................................................................................................................... 61

7.2 Troubleshooting for Errors Without Alarm Reporting ............................................................... 61

7.2.1 Boot Failures .................................................................................................................................. 61

7.2.1.1 Boot Failure ...................................................................................................................................61

7.2.1.2 Shutdown Failure...........................................................................................................................62

7.2.2 Connection Failures ....................................................................................................................... 63

7.2.2.1 No Wi-Fi Hotspot ...........................................................................................................................63

7.2.2.2 Low Signal Strength of the Wi-Fi Hotspot .......................................................................................63

7.2.2.3 Wrong Password ...........................................................................................................................64

7.2.3 Image Errors .................................................................................................................................. 65

7.2.3.1 Abnormal Interruption of Image Display..........................................................................................65

7.2.3.2 Image Freezing and Delay .............................................................................................................66

7.2.3.3 Image Interference.........................................................................................................................66

7.2.3.4 Poor Image Quality ........................................................................................................................67

7.2.3.5 Short Battery Life During Scanning ................................................................................................68

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7.2.4 Charging Failures (Charging Station) ............................................................................................ 68

7.2.4.1 Probe Charging Failure ..................................................................................................................68

7.2.4.2 Slow Probe Charging .....................................................................................................................69

7.2.5 Charging Failures (Charging Cable).............................................................................................. 70

7.2.5.1 Probe Charging Failure ..................................................................................................................70

7.2.5.2 Slow Probe Charging .....................................................................................................................71

7.2.6 Charging Failures (Charging Case)............................................................................................... 72

7.2.6.1 Probe Charging Failure ..................................................................................................................72

7.2.6.2 Slow Probe Charging .....................................................................................................................73

8 Appendix ...................................................................................................................................... 75

8.1 Phantom Usage Illustration .......................................................................................................... 75

8.2 Electrical Safety Maintenance ..................................................................................................... 78

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1 Preface

1.1 Revision History

The revision number of this service manual is subject to update without prior notice due to

changes in software or technical specifications. The following table lists the revision history.

Version Revision Date Revision Description Effective Date

1.0 2023–5–17 Initial release

1.2 Descriptions Committed

This section describes the symbols, common formats, GUI element references, and keyboard and

mouse operation conventions in the manual.

•GUI element conventions

Display Format Description

Boldface Indicates the name of an interface control or

a table. For example, click OK.

>Multi-level menus are separated by the >

sign. For example, File>New>Folder

indicates Folder under the New sub-menu

item of the File menu.

•Keyboard operation conventions

Display Format Description

Boldface Indicates a key name,

for example, Enter,Tab,Backspace, and

the lower-case letter a.

"Key 1+ Key 2" Indicates that multiple keys are pressed

simultaneously on the keyboard.

For example, Ctrl+Alt+A indicates that

Ctrl,Alt, and Akeys are pressed

simultaneously.

"Key 1, Key 2" Indicates that Key 1 is pressed and released

and then Key 2 is pressed.

For example, Alt,Findicates that Alt is

pressed and released, and then Fis

pressed.

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•Mouse and touch screen operation conventions

Display Format Description

Tap Touch the target on the touch screen with

your finger, and leave immediately.

Long press Keep your finger on the target on the touch

screen for a while.

Slide Keep your finger in contact with the screen,

and move your finger.

Click Quickly press and release a button of the

mouse.

Double-click Press and release a button of the mouse

twice in succession.

Drag Press and hold a button of the mouse, and

move the mouse.

Keep your finger in contact with the target on

the screen, and move your finger to a

specified position.

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1.3 Service Contact

Company name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen,

Guangdong, China

Postcode: 518057

Website: www.mindray.com

E-mail: service@mindray.com

Fax: +86 755 26582680

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1.4 Intellectual Property Statement

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (hereinafter referred to as Mindray) owns the

intellectual property rights to this service manual and the products mentioned herein.

modification, or translation of any part in this manual without the written permission of Mindray is

strictly forbidden.

, , , , , , , ,

RealTF, TrackWB, TrueTCR, Q-pick, AutoOLC, iVision, DBF, DRF, RDA, DRA, DFS, SyncNavi,

GQ-Ana, One-touchIP, Holo-IS, Opt-VRA, SuperVE-Cine, NFPDSC, iTouch, iStation, BeneView,

and SmarTemp are trademarks or registered trademarks owned by Mindray in China and other

countries.

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1.5 Statement

•Before performing product maintenance, read this service manual carefully and ensure that

you fully understand its content to ensure proper maintenance and avoid product damage or

personal injury.

•This service manual describes the product according to the most complete configuration;

some of the content may not apply to the product you are maintaining. If you have any

questions, contact Mindray customer service.

•Due to the software version of the system and the configuration of optional accessories, the

operation interfaces given in this manual may be different from the actual interfaces displayed

on the system. The operation interfaces are subject to your purchased machine.

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1.6 Applicability

This document is suitable for the following persons who are responsible for the maintenance of

this product:

•Service engineers

•Authorized service personnel

•Service representatives

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1.7 Responsibility on the Manufacturer Party

The warranty period of the product is stipulated in the sales contract.

Consumables are not covered by the warranty service. Consumables refer to the disposable

materials that must be replaced after one use or fragile materials that need to be replaced

periodically.

The warranty period starts from the installation date filled in the Warranty Form delivered with the

product, which is the only credential for the warranty period. To protect your rights and interests,

fill in the Warranty Form after installation of the device and provide the second half of the form (for

Mindray) to the installation personnel or mail it back to the customer service department of

Mindray.

Note that the warranty service will not be provided in either of the following cases:

•The customer fails to fill in and return the Warranty Form within 30 days after the device is

accepted.

•The device serial number (credential for the warranty service) provided by the customer is

incorrect.

Mindray offers free after-sales services for the product within the warranty period, but you need to

pay for the repair service and replacement parts if the fault of the product is caused by any of the

following reasons:

•Artificial damage

•Improper use

•Grid voltage beyond the specified range of the product

•Irresistible natural disasters

•Use of parts, accessories, or consumables that are not certified by Mindray or repair of the

device by unauthorized personnel

•Other product-irrelevant factors

Mindray can continue to provide charged maintenance service after the warranty period expires.

If you do not pay for the maintenance service or delay the payment, Mindray will suspend the

service until the payment is received.

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1.8 Safety

This chapter provides safety guidelines for the use of the system and describes the safety labels

and symbols on the system.

Symbol Description

In this service manual, the signal words , ,

, , and are used regarding safety and other important

instructions. The signal words and their meanings are defined as follows. Familiarize yourself with

the meanings of these words before reading this manual.

Symbol and Word Description

Indicates an imminently hazardous situation

which, if not avoided, will result in death or

serious injury.

Indicates a potentially hazardous situation

which, if not avoided, can result in death or

serious injury.

Indicates a potentially hazardous situation

which, if not avoided, can result in minor or

moderate injury.

Indicates a potentially hazardous situation

which, if not avoided, can result in property

damage.

Indicates the important information that helps

you use the system more effectively.

Symbols on the Device

The following tables describe the locations of the safety symbols and warning labels on the

device, as well as the important information they communicate. Remember these symbols and

labels for proper use of the device.

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Symbol Description

Type-BF applied part

The ECG module connected to this system is

also a type-BF applied part.

Refer to the manual delivered with the

system for details.

Warning Labels

SN Warning Label Description

1. a. Do not place the system on

a sloped surface. Otherwise,

the system may slide,

resulting in personal injury or

system malfunction. Two

people are required to move

the system over a sloped

surface.

b. Do not sit on the trolley.

c. Do not push the trolley

when its casters are locked.

d

Refer to the manual

delivered with the system

for details.

2. Be cautious of hand injury.

3. Do not place heavy objects on

the system.

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General Symbols

The following table describes the symbols on the device.

Symbol Description

Type-BF applied part

Refer to the manual delivered with the

system for details.

Indicates alternating current.

Indicates the protection ground (earth).

Pen probe port

Equipotentiality

Probe port

Network port

High-speed USB port

VGA VGA input

S-VIDEO Reserved, used for separate video output

AUDIO Indicates audio input and output.

HDMI High definition multimedia port

When the probe unlock handle is in the

position, the probe can be removed or

connected.

When the probe unlock handle is in the

position, the probe is locked and cannot be

removed or connected.

Central brake locking symbol

Product serial number

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Symbol Description

Manufacture date

Manufacturer

Authorized representative in the European

Community

Temperature limit

Humidity limit

Atmospheric pressure limit

The environment-friendly use period of the

device is 20 years.

(The environment-friendly use period of an

electronic product is the duration in which the

toxic and hazardous substances or elements

contained in this product will not leak or

mutate in proper use, and the use of the

product will not cause serious pollution to the

environment or serious personal injuries or

property damage.)

Non-ionizing radiation

Power switch of the system

S probe

Battery power indicator

Positive inside and negative outside

The CE marks indicates that the

corresponding product model complies with

the EU laws and regulations on medical

devices.

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Safety Guidelines

When using the system, strictly follow the safety guidelines below to ensure your personal safety.

Do not use the system in the presence of flammable gases (such as anesthetic gases,

oxygen, and hydrogen) or flammable liquids (such as ethanol), as doing so may cause

an explosion.

Electrical Safety

•The power plugs of the system and its peripherals must be connected to wall

outlets with the power rating specified on the product's power rating label. The

use of a multifunctional power outlet may interfere with system grounding and

lead to overhigh leakage current. Use the power cable delivered with the

system.

•Disconnect the AC power supply before you clean or uninstall the ultrasound

machine; otherwise, electric shock may occur.

•When using peripherals not powered by the auxiliary output of the ultrasound

system or peripherals not certified by Mindray, make sure the total leakage

current of the peripherals and the ultrasound system is within the range

specified in the local electric safety standard for medical devices. For

example, GB 9706.15 requires that the touch current on the ME system parts

or between the parts in the patient environment should be within 100 μA when

the system is operating in normal state and within 500 μA when the protection

ground cable is disconnected. The user shall be responsible for determining

whether the total leakage current complies with the local standard.

•During system maintenance or assembly, make sure all the other cables are

connected properly before you connect the battery cable. Otherwise, the

system may be damaged due to hot plugging of cables.

•Do not use this system with any high-frequency electrosurgical scalpel, high-

frequency treatment equipment, or defibrillator, as doing so may cause an

electric shock to the patient.

•This system is not resistant to water. Therefore, it must be protected from any

liquid to prevent electric shock.

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•Do not connect or disconnect the power plug of the system or any of its accessories

(such as the printer or video recorder) before turning off the power switch. Doing so

may damage the system or its accessories, or cause electric shock.

•Keep the system away from electromagnetic radiation during performance testing.

•Do not touch the electrostatic sensitive areas of the system directly. If you need to

touch such areas, wear ESD gloves.

•The ECG module must be used with the ECG leads delivered with the ECG module.

Using other ECG leads may result in electric shock.

Mechanical Safety

•Hold the handle when moving the system. If you hold other parts, the system

may be damaged due to unbalanced force. Do not push the device leftward or

rightward, in which case the device may fall down.

•Do not subject the probes to knocks or drops. The use of a damaged

ultrasound probe may cause an electric shock to the patient.

•Before moving the device on stairs, make sure the peripherals have been fixed

securely. Then, move the device slowly and steadily to prevent it from falling down.

•Avoid excessive vibrations or collisions to the device (for example, when moving it)

to prevent its parts from falling and protect it from mechanical damage.

•Mount the device on a flat plane with its casters locked. Otherwise, damage may

occur due to accidental movement of the device.

•Do not move the device on a plane with an over 5° slope; or the system may fall down.

•The device can be moved only in power-off or standby state. Moving the device in

running state may damage its hard disk.

Personnel Safety

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•The user is not allowed to open the shell or control panel or disassemble the

device.

•All maintenance work must be done by professional maintenance personnel

authorized by Mindray.

•Only the personnel trained by Mindray are allowed to maintain the device.

Miscellaneous

For more information about the use of the ultrasonic system, refer to the user

manual.

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