TE Air Color Doppler Service Manual Ver 1.0

Diagnostic Ultrasound System Service Manual

Table of Contents

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 ii

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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 iii

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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 iv

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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 v

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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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Diagnostic Ultrasound System

1 Preface

Service Manual

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

1.0

2023–5–17

Initial release

Effective Date

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 A keys are pressed simultaneously.

"Key 1, Key 2"

Indicates that Key 1 is pressed and released and then Key 2 is pressed. For example, Alt, F indicates that Alt is pressed and released, and then F is 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: [email protected] 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. © 2021 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. Duplication, modification, or translation of any part in this manual without the written permission of Mindray is strictly forbidden. ,

,

,

,

,

,

,

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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 Preface

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 1.

Warning Label

Description 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 HDMI

Indicates audio input and output. 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, highfrequency 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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