Mindray M9, M9, M9Vet, M8, M8 Elite, M8 Elite User manual

M9/M9T/M9CV/M9GI/M9Vet/ M8/M8CV/M8T/M8GI/M8 Elite Diagnostic Ultrasound System Service Manual (Advanced) Revision 25.0 Table of Contents Table of Contents....................................................................................................................i Version Information ................................................................................................................I Intellectual Property Statement ...........................................................................................III Applicability ..........................................................................................................................III Responsibility of Mindray ....................................................................................................III Warranty Statements ........................................................................................................... IV Customer Service Department ........................................................................................... IV Descriptions Committed ...................................................................................................... V 1 Safety Precautions ..................................................................................................... 1-1 1.1 1.2 Meaning of Signal Words ..................................................................................................... 1-1 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 ............................................................................................................... 1-3 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 Product Specifications ............................................................................................... 2-1 2.1 Introduction........................................................................................................................... 2-1 2.1.1 Intended Use ................................................................................................................ 2-1 2.1.2 System Appearance ..................................................................................................... 2-1 2.1.3 Trolley Appearance ..................................................................................................... 2-10 2.1.4 Peripherals Supported ................................................................................................ 2-13 2.2 Specifications ..................................................................................................................... 2-14 2.2.1 External Dimensions and Weight ............................................................................... 2-14 2.2.2 Electric Specifications ................................................................................................. 2-14 2.2.3 Environment Specifications ........................................................................................ 2-15 2.2.4 Monitor Specifications ................................................................................................. 2-15 3 System Installation ..................................................................................................... 3-1 3.1 Installation Preparations ....................................................................................................... 3-1 3.1.1 Electrical Requirements ................................................................................................ 3-1 3.1.2 Installation Condition .................................................................................................... 3-2 3.1.3 Installation Confirmation ............................................................................................... 3-2 3.2 Unpacking ............................................................................................................................ 3-2 3.2.1 Unpacking Process ....................................................................................................... 3-2 3.2.2 Check ............................................................................................................................ 3-7 3.3 Installation of Whole Device ................................................................................................. 3-7 3.3.1 Connecting Power Cable .............................................................................................. 3-7 3.3.2 Connecting ECG ........................................................................................................... 3-7 3.3.3 Connecting a Ultrasound Probe ................................................................................... 3-7 3.4 Installing Peripherals ............................................................................................................ 3-8 3.4.1 Connecting the Footswitch ........................................................................................... 3-8 i 3.4.2 Connecting/Removing a USB Memory Device............................................................. 3-8 3.4.3 Graph/Text Printer......................................................................................................... 3-9 3.4.4 Video Printer ............................................................................................................... 3-11 3.4.5 Barcode Reader.......................................................................................................... 3-12 3.5 Wired Network Connection ................................................................................................ 3-17 3.6 System Configuration ......................................................................................................... 3-17 3.6.1 Power-on Running ...................................................................................................... 3-17 3.6.2 Enter Doppler.............................................................................................................. 3-17 3.6.3 System Preset ............................................................................................................ 3-18 3.6.4 Print Preset ................................................................................................................. 3-19 3.6.5 Network Preset ........................................................................................................... 3-20 3.6.6 Network Configure ...................................................................................................... 3-24 3.6.7 DICOM/HL7 Preset ..................................................................................................... 3-30 3.6.8 Security ....................................................................................................................... 3-32 3.6.9 System Information Verification .................................................................................. 3-35 4 Product Principle ........................................................................................................ 4-1 4.1 4.2 General Structure of Main Unit’s Hardware System ............................................................ 4-1 Main Board ........................................................................................................................... 4-2 4.2.1 Power Supply................................................................................................................ 4-3 4.2.2 Backend ........................................................................................................................ 4-3 4.2.3 Front-end of Main Board ............................................................................................... 4-5 4.3 TR64 Board .......................................................................................................................... 4-6 4.4 Probe Board ......................................................................................................................... 4-6 4.5 PHV Power Supply Board .................................................................................................... 4-7 4.6 ECG Unit .............................................................................................................................. 4-7 4.7 Control Panel........................................................................................................................ 4-9 4.8 Main Display Unit ............................................................................................................... 4-10 4.9 Probe Extension Board ...................................................................................................... 4-11 4.10 Audio/Video Transfer Module ............................................................................................. 4-12 4.11 USB HUB Board ................................................................................................................. 4-13 4.12 Trolley Power Supply ......................................................................................................... 4-13 4.12.1 Connection Board of Trolley Power Supply ................................................................ 4-14 4.12.2 AC_DC Power Supply ................................................................................................ 4-14 4.12.3 Management Board of Trolley Battery ........................................................................ 4-14 4.13 System Power-on Control .................................................................................................. 4-15 4.14 Internal Connection Diagram of Main Unit and Trolley ...................................................... 4-17 4.15 Details in Main Unit’s Power-on ......................................................................................... 4-17 5 Checking Performance and Functions ..................................................................... 5-1 5.1 5.2 Description ........................................................................................................................... 5-1 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 5.4 Functions Checking .............................................................................................................. 5-5 5.4.1 Checking Flow .............................................................................................................. 5-5 5.4.2 Checking Content ......................................................................................................... 5-5 5.5 Performance Test ............................................................................................................... 5-11 5.5.1 Test Procedures .......................................................................................................... 5-11 ii 5.5.2 6 Test Content................................................................................................................ 5-12 Software Installation & Maintenance ........................................................................ 6-1 6.1 6.2 6.4 6.5 Enter Maintenance ............................................................................................................... 6-1 Software Installation/Restoration ......................................................................................... 6-2 Enter Windows ..................................................................................................................... 6-5 Software Maintenance.......................................................................................................... 6-6 6.5.1 Log Export .................................................................................................................... 6-6 6.6 Data Backup and Storage .................................................................................................... 6-6 6.6.1 Preset Data Management ............................................................................................. 6-6 6.6.2 Patient Data Backup and Restoration .......................................................................... 6-7 6.7 Introduction on HDD Partition Data ...................................................................................... 6-7 7 Field Replaceable Unit ............................................................................................... 7-1 7.1 7.2 8 Explosive View ..................................................................................................................... 7-2 Assembly Explosive View..................................................................................................... 7-3 7.2.1 Monitor Assembly (A0) ................................................................................................. 7-3 7.2.2 Control Panel Assembly (B0)........................................................................................ 7-5 7.2.3 Main Unit Assembly (C0) .............................................................................................. 7-7 7.2.4 Cables (D0)................................................................................................................. 7-12 7.2.5 Accessories (E0)......................................................................................................... 7-13 7.2.6 UMT-500 Mobile Trolley (F0) ...................................................................................... 7-15 Structure and Assembly/Disassembly...................................................................... 8-1 8.1 Structure of the Complete System ....................................................................................... 8-1 8.1.1 Main Unit....................................................................................................................... 8-1 8.1.2 Mobile Trolley................................................................................................................ 8-2 8.2 Main Unit Assembly/Disassembly ........................................................................................ 8-3 8.2.1 Preparation ................................................................................................................... 8-3 8.2.2 Battery .......................................................................................................................... 8-4 8.2.3 Dust-proof Mesh of Main Unit ....................................................................................... 8-5 8.2.4 Network Adaptor ........................................................................................................... 8-6 8.2.5 SSD Card...................................................................................................................... 8-7 8.2.6 Control Panel and Monitor ............................................................................................ 8-8 8.2.7 ECG Assembly............................................................................................................ 8-10 8.2.8 Fan .............................................................................................................................. 8-12 8.2.9 Probe Board Assembly ............................................................................................... 8-12 8.2.10 Machine Board Assembly ........................................................................................... 8-14 8.2.11 Control Panel Assembly ............................................................................................. 8-18 8.2.12 Display (monitor) Assembly ........................................................................................ 8-23 8.3 Trolley Assembly/Disassembly ........................................................................................... 8-27 8.3.1 Preparation ................................................................................................................. 8-27 8.3.2 Storage Box ................................................................................................................ 8-28 8.3.3 Power Supply Assembly ............................................................................................. 8-29 8.3.4 Trolley Panel Board Assembly .................................................................................... 8-33 8.3.5 Spring Assembly ......................................................................................................... 8-34 8.3.6 Cast-aluminum Base of Trolley Panel ........................................................................ 8-40 8.3.7 Lifting Column ............................................................................................................. 8-42 8.3.8 Trolley Base Assembly ............................................................................................... 8-43 8.3.9 Installation of probe holder ......................................................................................... 8-45 8.3.10 Disassembly of the probe holder ................................................................................ 8-47 8.3.11 Disassembly of intracavity probe holder ..................................................................... 8-47 9 Installation of Option Modules .................................................................................. 9-1 iii 9.1 9.2 Installation of Optional Devices to Software......................................................................... 9-1 Installation of the Accessory Kits and Optional Devices to Hardware ................................. 9-3 9.2.1 Storage Tray ................................................................................................................. 9-4 9.2.2 Probe Extender Assembly ............................................................................................ 9-4 9.2.3 Audio/Video Extender Assembly .................................................................................. 9-5 9.2.4 Trolley Installation ......................................................................................................... 9-6 10 System Diagnosis and Support............................................................................... 10-1 10.1 General Status Indicator ..................................................................................................... 10-1 10.1.1 Indicators of Control Panel ......................................................................................... 10-1 10.1.2 Status of Whole Machine ............................................................................................ 10-2 10.2 Get Whole Machine Started ............................................................................................... 10-3 10.2.1 Power-on Process of Whole Machine Supplied by AC............................................... 10-4 10.2.2 The Start-up Process of BIOS .................................................................................... 10-4 10.2.3 Windows Start-up........................................................................................................ 10-4 10.2.4 The Start-up of Doppler .............................................................................................. 10-5 10.3 Alarming and Abnormal Information ................................................................................... 10-7 10.3.1 Power Error................................................................................................................. 10-7 10.3.2 Abnormal Voltage of System Power ........................................................................... 10-9 10.3.3 Abnormal Temperature ............................................................................................... 10-9 10.3.4 Fan Error................................................................................................................... 10-10 10.3.5 PHV Error ................................................................................................................. 10-10 10.3.6 Other Errors .............................................................................................................. 10-11 10.4 Self-test ............................................................................................................................ 10-11 10.4.1 Self-test Introduction ................................................................................................. 10-11 10.4.2 Operation Procedure of Maintenance Self-test ........................................................ 10-12 10.4.3 User Self-test ............................................................................................................ 10-16 10.4.4 Test Report ............................................................................................................... 10-18 11 Care and Maintenance...............................................................................................11-1 11.1 Overview ............................................................................................................................ 11-1 11.1.1 Tools, Measurement Devices and Consumables ....................................................... 11-1 11.1.2 Routine Maintenance Items ........................................................................................ 11-2 11.2 Cleaning ............................................................................................................................. 11-3 11.2.1 System Cleaning......................................................................................................... 11-3 11.2.2 Peripherals Cleaning .................................................................................................. 11-7 11.3 Check ................................................................................................................................. 11-7 11.3.1 General Check ............................................................................................................ 11-7 11.3.2 System Function Check .............................................................................................. 11-8 11.3.3 Check for Peripherals and Optional Functions ........................................................... 11-8 11.3.4 Mechanical Safety Inspection ..................................................................................... 11-9 12 Troubleshooting of Regular Malfunctions.............................................................. 12-1 12.1 Troubleshooting as the System is Disabled to Power On .................................................. 12-1 12.1.1 Related Modules or Boards ........................................................................................ 12-1 12.1.2 Key Points Supporting Troubleshooting ..................................................................... 12-1 12.1.3 Troubleshooting as the System is Disabled to Power On .......................................... 12-1 12.2 The System Cannot Perform Troubleshooting ................................................................... 12-2 12.2.1 Related Modules or Boards ........................................................................................ 12-2 12.2.2 Key Points Supporting Troubleshooting ..................................................................... 12-2 12.2.3 The System Cannot Perform Troubleshooting ........................................................... 12-3 12.3 Image Troubleshooting ....................................................................................................... 12-3 12.3.1 Related Modules or Boards ........................................................................................ 12-3 iv 12.3.2 Key Points Supporting Troubleshooting ..................................................................... 12-3 12.3.3 Image Troubleshooting ............................................................................................... 12-4 12.4 Troubleshooting Control Panel ........................................................................................... 12-4 12.4.1 Related Modules or Boards ........................................................................................ 12-4 12.4.2 Key Points Supporting Troubleshooting ..................................................................... 12-4 12.4.3 Troubleshooting Control Panel ................................................................................... 12-5 12.5 Troubleshooting LCD Display............................................................................................. 12-5 12.5.1 Related Modules or Boards ........................................................................................ 12-5 12.5.2 Key Points Supporting Troubleshooting ..................................................................... 12-6 12.5.3 Troubleshooting Monitor ............................................................................................. 12-6 12.6 Troubleshooting for ECG Module ....................................................................................... 12-6 12.6.1 Related Modules or Boards ........................................................................................ 12-6 12.6.2 Key Points Supporting Troubleshooting ..................................................................... 12-6 12.6.3 Troubleshooting for ECG Module ............................................................................... 12-7 Appendix A Electrical Safety Inspection .................................................................. A-1 Appendix B Phantom Usage Illustration................................................................... B-1 Appendix C Description of Self-test Test Items ....................................................... C-1 v Version Information Mindray may revise this publication from time to time without written notice. The detailed information is shown below: Version Release Date 1.0 2013.12.30 Reason for Revision Initial release Add the picture of field replaceable unit in Chapter 7.1; 2.0 2014.1.27 3.0 2014.3.19 4.0 2014.6.12 Change the order number of the speaker and cable in Chapter 7.1; Change the disassembly method of the shield cover of PHV board in Chapter 8.2.10 Add the precaution of the disassembly of the CPU assembly; Update the content of the appendix C.1.25 Update figures in chapter 8.2.7 since a pressure plate is added for ECG cable; Update contents of Z0501 in appendix C.1.25 Change FRU materual No. in Chapter 7; Change iStorage screen picture in section 3.5.5.1; 5.0 2014.9.24 6.0 2015.2.15 Add section 3.5.6 Network Configure; Add in “4-protective grounding impedance” testing applies to M9 portable system with UMT-500Plus trolley (with power supply) only in Appendix A. Add SONY UP-D898MD, UP-X898MD printers in chapter 2.1.4 along with compatibility description. Section 7.1, add the part number of main board and SSD card used for CE M9GI 7.0 2015.5 Section 7.1, change the picture of SSD card Section C.1.27, change the picture of keyboard testing Add M9GI product model 8.0 2015.8 Section 3.5, add the wired network connection information. 11.0 2016.4.7 Section 7, change the wired network connection information. 12.0 2016.5.20 Section 7, the modification of the FRU. 13.0 2016.8.9 Update the labels in 1.2.2. Add M9Vet model. Add 4D and TEE related self-test items in C.1.16 – C.1.19 chapter 14.0 2017.1 Update trolley probe holder part number and add part number of intracavity probe holder in 7.2 chapter Add assembly/disassembly descriptions in 8.3.9 – 8.3.11 for probe holders. 15.0 2017.6 Update Monitor Assembly(eDP screen/FRU), Monitor Assembly(LVDS2eDP/FRU), CPU Module(6100 PC module/eDP output/FRU), CPU Module(6100 PC module/LVDS output/FRU), M9 I Main Board(eDP output+M.2 port WiFi/FRU), M9 Main Board(M9GI/eDP output+M.2 port WiFi/FRU), Wireless net adapter(M.2 port), iDock51 Audio/Video Extend Module, SSD card FRU, Monitor front cover assembly FRU, control panel assembly FRU in chapter 7.1. Update Audio/Video extend module FRU in chapter 9.2. 16.0 2017.9 Add the FRU number of Russian keyboard. 17.0 2017.12 Change the FRU number of TR64 board in chapter 7.1. 1. Add M8 series product models. 18.0 2017.06 2. Add FRUs. 3. Add anti-virus, Q-Path, EAP network. 1. Update the unpacking information in section 3.2 19.0 2018.09 20.0 2018.10 21.0 2019.01 22.0 2019.7 23.0 2019.09 Change the FRU number of Control Panel Assembly and PC Keyboard in chapter 7.1. 24.0 2020.2 Change the FRU information of CPU module in chapter 7.1. 25.0 2020.3 Update EAP network management; add Windows 10 activation; Change the FRU information in chapter 7.1. 2. Update th screw type in section 8.3.3 1. Add the lithium-ion Battery FRU 2. Modify the screwdriver size. Change the FRU number of Small keyboard assembly(FRU) in chapter 7.1. Change DS6707 to DS4308 in Chapter 2.1.4. Change the FRU number of Main Board, Control panel assembly (FRU) and Silicon keypad in chapter 7.1. © 2013-2020 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All Rights Reserved. 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, trademark, or patents, and does not convey any license under the intellectual property rights 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. is the trademark of Mindray. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners. Applicability This service manual is intended as a guide for technically qualified personnel during service procedures. This service manual describes the product according to the most complete configuration; some of the content may not apply to the specific product you are servicing. If you have any questions, please contact the Mindray Customer Service Department (contact information is below). Do not attempt to service this equipment unless this service manual has been consulted and is understood. Failure to do so may result in personal injury or product damage. Responsibility of Mindray Contents of this manual are subject to change without prior notice. Please check with the Mindray Customer Service Department for any updates or changes to this manual. All information contained in this manual is believed to be correct as of the date of its publication. 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 shall not be responsible for the effects on safety, reliability, and performance of this product if: Installation operations, expansions, changes, modifications and repairs of this product are conducted by personnel not authorized by Mindray; The electrical installation of the relevant room does not comply with the applicable national and local requirements; The product is not used in accordance with the instructions for use. III Warranty Statements Mindray warrants that components within the ultrasound system under warranty will be free from defects in workmanship and materials for the amount of time specified under Mindray’s then-current warranty policy (please check with the Mindray Customer Service Department for the applicable warranty period for each system). Under this warranty, Mindray will repair or replace (at Mindray’s option) any defective component at no charge for materials according to Mindray’s then-current warranty policy. This warranty does not cover consumable items such as, but not limited to, traveling carrying case, acoustic gel, paper, disposable or one-off materials, and sampling materials. Recommended preventative maintenance, as prescribed in the Service Manual, is the responsibility of the user, and is not covered by this warranty. Mindray will not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly arising from the use of its products. Liability under this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or replacing the affected products, at Mindray’s option, at the factory or at an authorized Distributor, for any product which shall under normal use and service appear to Mindray to have been defective in material or workmanship. No agent, employee, or representative of Mindray has any authority to bind Mindray to any affirmation, representation, or warranty concerning its products, and any affirmation, representation, or warranty made by any agent, employee, or representative shall not be enforceable by buyer or user. THIS WARRANTY IS EXPRESSLY IN LIEU OF, AND MINDRAY EXPRESSLY DISCLAIMS, ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF NON-INFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE, AND OF ANY OTHER OBLIGATION ON THE PART OF MINDRAY. Damage to any product or parts through misuse, neglect, accident, or by affixing any non-standard accessory attachments or by any customer modification voids this warranty. Mindray makes no warranty whatever in regard to trade accessories, such being subject to the warranty of their respective manufacturers. A condition of this warranty is that the equipment or any accessories which are claimed to be defective be returned, when authorized, to the appropriate Mindray affiliate. Please contact the Mindray Customer Service Department for appropriate details for your region. Customer Service Department Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address: Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057,P.R.China Website: www.mindray.com E-mail Address: [email protected] Tel: +86 755 81888998 Fax: +86 755 26582680 IV Descriptions Committed The following marks are used for describing keys on the control panel, menu items, buttons on dialog boxes and other basic operations in the manual: . <Button>: the angle bracket for enclosing the button’s name refers to the buttons on the keyboard, rotation knobs, switches or controls. [Menu item or key]: the square bracket for enclosing menu item or key refers to the menu items or the keys on dialog boxes. Click [Menu item or key]: move the cursor to the menu item or the key on the dialog box, and then press <Set>. Or, click other optional keys on touch screen. [Menu item]-[Sub-menu item]: select sub-menu item based on the operation path V 1 Safety Precautions This chapter describes important issues related to safety precautions, as well as the labels and icons on the ultrasound machine. 1.1 Meaning of Signal Words In this service manual, the signal words DANGER, WARNING, CAUTION and NOTE are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please be aware of the meaning of the signal words before reading this manual. Signal word Description 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. Description 1.2 Important information that helps you to use the system more effectively. Symbols The following tables provide location and information of the safety symbols and warning labels, please read carefully. 1.2.1 Meaning of Safety Symbols Symbol Position Description Type-BF applied part Right side of main unit Note: The ultrasound probes connected to this system are type-BF applied parts. The ECG module connected to this system is Type-BF applied part. Caution Main unit Safety Precautions 1-1 1.2.2 No. Warning Labels Warning Labels 1. The following labels are available when the system works with the mobile trolley. 2. Description Label Position Read the manual carefully before using the system. On the upper left corner of the control panel 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. On the left part of the trolley panel b. Do not sit on the system. c. DO NOT push the system when the casters are locked. Non-ionizing radiation 3 1.2.3 On the bottom part of the ultrasound system General Symbols This symbols used in the device are listed in the following table. Meanings are: No. Symbol Description 1 Type-BF applied part 2 To avoid safety accidents, refer to relevant content in the manual. 3 Dangerous voltage 4 No user serviceable parts (applied to the power adapter) 5 Indoor, dry location use only (applied to the power adapter) 6 Power button 7 Probe sockets 8 USB port 9 S-VIDEO signal port; VIDEO signal port 10 AC (Alternating current) 11 Battery Status Indicator 1-2 Safety Precautions No. Symbol Description 12 Pencil probe port (reserved) 13 IO extend port 14 unlocked symbol 15 locked symbol 16 Battery installation position indicator 17 Connects serial port devices 18 ECG function 19 Connects a display monitor or projector 20 Audio signal 21 Microphone input jack 22 Remote control port 23 Product serial number 24 Manufacture date 25 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. 26 The environment-protective application period of the system is 20 years period. 27 Standby 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. Safety Precautions 1-3 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. 4. You should use the ECG leads provided with the ECG module. Otherwise it may result in electric shock.5. Maximum output power of the trolley is 240 VA. 1-4 Safety Precautions 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 Note: Personnel Safety 1. 2. 3. 1.3.4 Note: The user is not allowed to open the covers and panel of the system, neither device disassemble is allowed. To ensure the system performance and safety, only Mindray engineers or engineers authorized by Mindray can perform maintenance. Only technical professionals from Mindray or engineers authorized by Mindray after training can perform maintenance. Others For detailed operation and other information about the ultrasound system, please refer to the operator’s manual. Safety Precautions 1-5 2 Product Specifications 2.1 Introduction 2.1.1 Intended Use The diagnostic ultrasound system is intended for use in clinical ultrasonic diagnosis. 2.1.2 System Appearance Product Specifications 2-1 No. Name Function 1 Monitor Displays the images and parameters during the scan. 2 Control Panel Operator-system interface or control 3 Handle Used for carrying the system Power input port 4 Connects the power adapter 5 HDMI port Outputs high definition multimedia signals 6 USB port Connects USB devices (2 ports) 7 ECG port Connects ECG lead or DC-IN cable 8 Probe port Connects a probe to the main unit; or connects a probe extend module Locks or unlocks the probe connected with the main unit 9 Probe locking lever :locked symbol :unlocked symbol 10 2.1.2.1 Pencil probe port Connects to a pencil probe. Extend Modules Extend modules to the system are: probe extend module, video/audio extend module. Probe extend module No. Name Function <1> Connector Connects to the probe port of the main unit, and extends the probe port to three. <2> Probe port To extend ports for connecting probes 2-2 Product Specifications Note: 1. Perform the plug and unplug of the probe module. To reduce the wastage of probe module, the operation should be conducted under frozen status of the system. 2. If you use the probe extend module to connect a probe, the image quality may be degraded. Audio/Video extend module Panel introduction No. <1> Indicator Function Used for connecting to main unit. The green indicator is on. <2> Used for audio signal output. <3> Used for separate video output. <4> Symbol VGA VGA signal output Connection Connect the V/A extend module to the main unit via an HDMI port. As shown in the following figure. Product Specifications 2-3 2.1.2.2 Control Panel 2-4 Product Specifications No. Name English Name Description 1. B mode button B Press to enter B mode 2. P mode button P Press to enter Power mode. 3. C mode button C Press to enter the Color mode. 4. CW mode button CW Press to enter CW mode. 5. PW mode button PW Press to enter the PW mode. 6. TDI buttons TDI Press to enter TDI mode 7. M mode button M Press to enter the M mode. Switching key: Press to change the currently active window. Functional 8. Update button Update 9. Measure button Measure Press to measurement 10. Caliper button Caliper Press to enter/exit general measurement 11. Trackball / To move the cursor. 12. Confirm (left<Set> key) key 13. Confirm key <Set> key) (right 14. Angle adjustment and quick angle knob Angle Adjust the angle 15. Gain and iTouch knob iTouch Adjust the gain of the image in various modes 16. Cine button Cine Start or end capturing the image in iScape enter/exit application / Press to confirm key / Press to enter iTouch mode Press to enter/ exit the Cine Review status. Product Specifications 2-5 No. Name English Name Description 17. Clear button Clear Press to clear off the comments or measurement calipers on the screen. 18. Freeze button Freeze Press to freeze or defreeze the image. 19. Power button / Power button 20. Soft menu adjustment button 1 / Press to select the soft menu items displayed on the bottom of the screen. Refer to the subsequent contents for specific functions. 21. Soft menu adjustment button 2 / Press to select the soft menu items displayed on the bottom of the screen. Refer to the subsequent contents for specific functions. 22. Soft menu adjustment button 3 / Press to select the soft menu items displayed on the bottom of the screen. Refer to the subsequent contents for specific functions. 23. Soft menu page up button / Press to turn the soft menu pages upward. 24. Soft menu page down button / Press to turn soft menu pages downward. 25. Soft menu display mode switch button / Press to switch the mode for the soft menu. 26. Soft menu adjustment button 4 / Press to select the soft menu items displayed on the bottom of the screen. Refer to the subsequent contents for specific functions. 27. Soft menu adjustment button 5 / Press to select the soft menu items displayed on the bottom of the screen. Refer to the subsequent contents for specific functions. 28. Soft menu adjustment button 6 / Press to select the soft menu items displayed on the bottom of the screen. Refer to the subsequent contents for specific functions. 29. Patient button Patient Press to enter the Patient information screen. 30. Probe/exam switch button Probe/Exam Press to switch probe and exam mode 31. Image review button Review Press to review the stored images. 32. End exam button End Exam Press to end an exam. 33. User-defined key 3 P3 User-defined key 34. User-defined key 2 P2 User-defined key 35. Body mark button Body Mark Press to enter/ exit the body mark mode. information 2-6 Product Specifications mode No. Name English Name Description 36. Cursor button Cursor Press to show/hide the cursor 37. Baseline adjustment and interface Baseline Adjust the baseline parameter. 38. Scale adjustment button and auxiliary interface Scale Adjust scale parameter. 39. Steer/Invert adjustment button Steer/Invert Adjust steer/invert parameter. 40. TGC and functional interface / Move to adjust depth gain compensation. 41. Single-window button Single Press to enter active window in Dual or Quad mode. position button auxiliary window Press to enter the Dual mode from another mode; 42. Dual-split button 43. Image zoom and spot/pan zoom switch knob. Zoom Press to enter or exit zoom status. 44. Depth adjustment button and fictional interface Depth Adjust depth 45. Focus position adjustment button and functional interface Focus Position Adjust the focus position. 46. Save static button Save1 Press to save the image; user-defined key. 47. User-defined key 1 P1 User-defined key 48. Standby indicator image status Dual Press to switch between the two windows in the Dual mode. Standby indicator / Standby: blinking in orange Other status: light off Hard disk status indicator 49. Hard disk indicator read The indicator blinks in green when hard disk is running. / The indicator is off on the other status. DO NOT move the machine when the indicator blinking in green. Otherwise the hard disk may be damaged by sudden shake. Product Specifications 2-7 No. Name English Name Description Battery status indicator. Charging status: It illuminates in orange when batteries are charging; 50. Battery indicator / It illuminates in green when batteries are charged to full capacity; Discharging status: It illuminates in green when batteries are charged fairly; It illuminates in orange when batteries run out. AC indicator The indicator is green at AC supply. 51. AC power indicator / 52. Esc Esc Cancel the operation or exit. 53. On-line help Help Press to open or close the accompanying help documents. 54. Patient data management system iStation Press to enter or exit patient information system. 55. Report Report Open/ close the exam report. 56. User-defined key 5-8 P5~P8 User-defined keys, functions of which can be defined in preset. 57. Stress echo Stress Echo Press to enter Stress Echo mode 58. Physiological signal Physio Press to enter or exit ECG. 59. Setup Setup Press to enter/ exit setup. 60. Biopsy Biopsy Press to enter biopsy 61. Set home Set Home Set home of comments The indicator is off when batteries (AC does not supply the power) supplied. Enter Quad mode in Non-Quad mode; 62. Quad-window display Quad Press to switch among interfaces in Quad mode. 63. iZoom (Full-screen Zooming) iZoom Enter/switch/exit full-screen zoom status. 64. Arrow Arrow Enter/exit the arrow comment status. 65. Home Home Activate the Home function: return to start position of comment. 66. Comments Comment Enter/exit the textual comment status. 2-8 Product Specifications No. Name English Name Description 67. Direction-control keys / Moves the cursor one letter each time; or, select the ambient one in a selectable area. 68. User-defined key 4 P4 User-defined keys, functions of which can be defined in preset. 69. Alphanumeric keys / Enter characters. For functions of undefined buttons or keys, the user can define it on your own. Refer to Operator manual for details about function setting. Functions of key combination The system supports multi-language input; you can use the key combinations. The key combinations include <Shift>, <Alt Gr>, <Ctrl> and some alphabet keys. <Shift> combination key <Shift> + key: input the upper left letter of the key. For the alphabet keys (<A>~<Z>), press <Shift>+key to input the letter of different case with the current state. [Alt Gr] combination key Combined with other letter keys, [Alt Gr] can be used for entering other languages. Press [Alt Gr], and meanwhile press a letter key, the letter on the upper-right corner of the key can be entered. [Ctrl] combination key In iStation or Review screen, use <Ctrl> and <Set> to select more than one patient. The combination of <Ctrl> and <Space> can switch the input between Chinese and English. Combination key used together with [Fn] key For those combination keys, press <Fn>+key to use the functions indicated with a frame on the key. No. Fn+ Name Function 1. → End Turn up the volume 2. ← Home Turn down the volume 3. ↑ Pg Up Increase the brightness of the LCD display. 4. ↓ Pg Dn Decrease the brightness of the LCD display. Product Specifications 2-9 2.1.3 Trolley Appearance 2-10 Product Specifications No. Name Function <1> Probe cable hook Manage probe cable <2> Ultrasound main unit Ultrasound system <3> Ascending/descending switch Press to adjust the height of operation panel <4> Anti-theft setting Used to fix the ultrasound system to the trolley. <5> Printer bracket Used to place the printer <6> Probe extend module Used to extend ports for connecting probes (optional) <7> Storage tray Used to place the adaptor, gel and other stuff. <8> USB port Connects USB devices (2 ports) <9> Probe holder Used to place probes temporarily Used for securing or moving the system <10> Caster <11> Audio/video extender Used to switch audio/video (optional) <12> Lifting column Used to adjust the height of operation panel Step on the second footswitch to lock the trolley. Step on the first footswitch to unlock the trolley. Product Specifications 2-11 No. Name Function <13> Moveable hook Manage probe cable <14> Storage box Used to place report or other stuff. <15> Power supply panel Used to offer output/input port, equipotential terminal for power supply. Battery indicator: It illuminates in orange when batteries are charging; It illuminates in green when batteries are in the charge. It illuminates in green when batteries are charged fairly; It illuminates in orange when batteries run out. AC power indicator: <16> Indicator The indicator is green at AC supply. The indicator is off when batteries (AC does not supply the power) supplied. 2.1.3.1 Power Supply Panel No. Name Function 1 Equipotential terminal Used for equipotential connection, balancing the protective earth potentials between the device and other electrical equipment. 2 Power inlet AC power inlet 3 Power supply outlet Supply power for optional peripheral devices (e.g. DVR) The symbol represents the equipotential terminal that is used for balancing the protective earth potentials between the system and other electrical equipment. 2-12 Product Specifications 1. Be sure to connect the equipotential wire before inserting the power plug into the receptacle; be sure to pull out the power plug from the receptacle before disconnecting the equipotential wire; otherwise electric shock may result. 2. When you connect another device to this system, you should use the equipotential wire to connect each of equipotential terminals; otherwise electric shock may result. 3. Connect the earth cable before turning ON the system. Disconnect the earth cable after turning OFF the system. Otherwise electric shock may result. 4. DO NOT connect this system to outlets with the same circuit breakers and fuses that control the current to devices such as life-support systems. If this 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. WARNING: 2.1.4 Peripherals Supported The peripheral devices supported by the system. The information is shown as below: No. 1. Item Graph/text printer Model HP Officejet 7000 wide format MITSUBISHI P95DW-N 2. Black/white video printer SONY UP-D897 SONY UP-D898MD SONY UP-X898MD 3. Digital color video printer SONY UP-D25MD SYMBOL DS4308 4. 1D/2DBarcode reader SYMBOL LS2208 JADAK HS-1M JADAK HS-1R 5. DVR 6. External DVD R/W drive ASUS DVD SDRW-08D2S-U NOTE: printer UP-D898MD and UP-X898MD should be used in compatible with 1.00.7 2015-1-27 OS version or above versions. You can also select “DVR: 897” in the DIGITAL -> - DRIVER path on the printer (use UPD897 driver) if OS is not updated. WARNING: This device complies with IEC60601-1-2:2014, and its RF emission meets the requirements of CISPR11 Class B. In a domestic environment, the customer or the user should guarantee to connect the system with Class B peripheral devices; otherwise RF interference may result and the customer or the user must take adequate measures accordingly. Product Specifications 2-13 2.2 Specifications 2.2.1 External Dimensions and Weight Size: (362±5) X (390±5) X (59±3) mm Weight (built-in battery assembly): < 6.5KG 2.2.2 Electric Specifications 2.2.2.1 AC IN Main unit Voltage 100-240V~ (for adapter) Frequency 50/60Hz (for adapter) Output power 2.0 A max (for adaptor) Trolley Voltage of power supply 100-240V~ Frequency of power supply 50/60Hz Output power 500VA 2.2.2.2 Battery Main unit battery: Voltage 14.8V Battery capacity 5800mAh (one battery) x 2 Trolley battery Voltage 14.8V Battery capacity 6600mAh (one battery) x 2 2-14 Product Specifications 2.2.3 Environment Specifications Operational Conditions Storage Conditions Ambient temperature 0℃-40℃ -20℃-55℃ Relative humidity 30%-85% (no condensation) 20%-95% (no condensation) Atmospheric pressure 700hPa-1060hPa 700hPa-1060hPa WARNING: 2.2.4 and Transportation Do not use this system in the conditions other than those specified. Monitor Specifications Working voltage 12V Monitor size 15.6 inches; 16: 9 Resolution 1920×1080 Visual angle ≥160 Product Specifications 2-15 3 3.1 Note: System Installation Installation Preparations Do not install the machine in the following locations: Locations near heat generators Locations with high humidity Locations with flammable gases 3.1.1 Electrical Requirements 3.1.1.1 Requirements of Regulator See Chapter 2.2.2 for power supply specifications. Due to the difference of the power supply stability of different districts, please advise the user to adopt a regulator of good quality and performance such as an on-line UPS. 3.1.1.2 Grounding Requirements The power cord of the system is a three-wire cable. The grounding terminal should be connected with a power grounding cable to ensure that protective grounding works normally. Make sure that the protective grounding works normally. WARNING: 3.1.1.3 DO NOT connect this system to outlets with the same circuit breakers and fuses that control the current of devices such as life-support systems. If this system malfunctions and generates an 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. EMI Limitation Ultrasound machines are susceptible to Electromagnetic Interference (EMI) from radio frequencies, magnetic fields, and transient in the air wiring. They also generate EMI. Possible EMI sources should be identified before the unit is installed. These sources include: medical lasers, scanners, monitors, cauterizing guns and so on. Besides, other devices that may result in high frequency electromagnetic interference such as mobile phone, radio transceiver and wireless remote control toys are not allowed to be presented or used in the room. Turn off those devices to make sure the ultrasound system can work in a normal way. System Installation 3-1 3.1.2 Installation Condition 3.1.2.1 Space Requirements Place the system with the necessary accessories at a proper position for convenient use. Place the system in a room with good ventilation or having an air conditioning unit. Maintain a generous – free air flowing space around the back and both sides of the system; failure may result due to increased rise in system operating temperature. A combination lighting system in the room (dim/bright) is recommended. Except the receptacle dedicated for the ultrasound system, at least 3-4 spare receptacles on the wall are available for the other medical devices and peripheral devices. Power outlet and place for any external peripheral are within 2 m of each other with peripheral within 1 m of the unit to connect cables. 3.1.2.2 Network Environment Both wireless and wired LAN functions are supported by this ultrasound device. Data transmission is allowed between different departments or areas without network cable. Network can be automatically connected after disconnection in case that the device is required to be moved, wireless transmission task can be recovered after the network resumed to normal condition. Confirm the network devices and network conditions before the installation. General information: default gateway IP address, and the other routers related information. DICOM application information: DICOM server name, DICOM port, channels, and IP address. 3.1.3 Installation Confirmation Please confirm the following items before installation: The video format of installation area or country. The language of installation area or country. Power frequency of installation area or country. The universal obstetrics formula and other measurement formula of installation area or country. The preset values of installation area or country that are different from the default values. The doctor’s operation habits. The items above prior to the installation training, and do the system settings according to the universal setting of installed region or country. 3.2 Unpacking Unpacking tool: scissor Installation duration: 2 people, 10 minutes. 3.2.1 Unpacking Process 3.2.1.1 Trolley Unpacking 1. Use the scissor to cut off four white tapes around the external package as follows: 3-2 System Installation 2. Take out the wooden cover. 3. Unpacking Remove the box upwards if the space is commodious enough; If the space is not commodious enough, please follow the instructions below: Press the middle of plastic clasp on the one side of the box as shown below; Pull out the plastic clasp; System Installation 3-3 Take out the plastic clasp out of the box (5 plastic clasps); Take off the plastic clasps to open the box. 4. Take out the foam of M9’s top plate. 5. Take out the auxiliary box. 3-4 System Installation 6. Take out foam lifting of the trolley. 7. Take out the fixing board 8. Turn the wooden cover to a slope. 9. Push the trolley down over the wooden slope. System Installation 3-5 3.2.1.2 Unpack Main Unit 1. Cut off four tapes of the external package, open the external box, and take out the auxiliary box and fixing foam; 2. Take out the trolley case. 3. Unlock the clasp to open the trolley case. 4. Remove the protective pad, and take out the main unit and adaptor. 5. Remove the protective pad and take out other attachments 3-6 System Installation 6. Take out the probe. Probe 3.2.2 Check 1. After unpacking, check the objects in the container with the package list to see if anything is in short supply or is wrong. 2. Inspect and make sure there is no damage to the machine, no indentation, no cracks. If there is, please contact Mindray Customer Service Department. 3.3 Installation of Whole Device 3.3.1 Connecting Power Cable Connect the connector of the power adapter to the adapter port in the system. Use a three-wire cable to connect the adapter with the external power supply. 3.3.2 Connecting ECG Connect the ECG cable to the corresponding lead interface on ECG of the ultrasound device. 3.3.3 Connecting a Ultrasound Probe WARNING: The probes, cables and connectors are in proper operating order and free from surface defects, cracks and peeling. Using a defective probe may cause electric shock. System Installation 3-7 Keep the cable end of the probe to the right side of the system, and insert the connector into the port of the system, and then press in fully. See the figure below. Toggle the locking lever to the top position. Place the probe properly to avoid being treaded or wrapping with other devices. DO NOT allow the probe head to hang free. 3.4 Installing Peripherals Please see Chapter 2.1.4 for the device model that the system supports. 3.4.1 Connecting the Footswitch The system supports footswitch of USB port type. As shown in the following figure. You can set the functions of the footswitch in the [Key Config] page. Refer to Operator’s Manual for footswitch setup. 3.4.2 Connecting/Removing a USB Memory Device WARNING: DO NOT directly remove a USB memory device; otherwise, the USB device and/or the ultrasound system may be damaged. 3-8 System Installation When connecting a USB memory device to the ultrasound system via a USB port, You can hear a sound if it is connected successfully. You can see the icon imaging screen. in the lower right corner of the . Press <Set>, as shown in the figure To remove the USB memory device: Click the icon below. Select the memory device to be removed. Click [OK] to remove the USB memory device. There will be sound feedback when removing the USB memory device. 3.4.3 Graph/Text Printer Connecting a local printer Note: Printers listed in Chapter 2.1.4 have drivers installed already. As shown in the figure below, a graph / text printer has a power cord and data cable. The power cord shall be directly plugged into a well-grounded outlet. 1. Connect the data cable to the USB port on the ultrasound system. 2. Power the system and the printer on. Installing the printer driver Perform the following steps to install the printer driver as needed: 1. Connect the data cable to the USB port on the ultrasound system. 2. Power the system and the printer on. 3. Put the installation optical disk of the printer driver into the external DVD R/W drive. Enter [Setup]→[Maintenance]→[Setup]→[Enter Windows], input the password. For details about obtaining password, please refer to "6.4 Enter Windows". The system enters the following page: System Installation 3-9 4. Double click the CD driver (HP8100 is given as an example). The installation is starting. 5. Complete the operation according to the prompts on the screen. Click [Finish] to end the installation. 6. Click [OK] to save the settings. Print Both report and image can be printed on a graph/text printer. 1. To set the default report printer and its attribute: (1) Enter "[Setup]→[Print Preset]" screen. (2) Select the "Report Print" column in the Service Type list. (3) In the “Property” frame, select printer from the driver list next to “Printer” in the lower screen and set the items as needed. (4) Click [Save] after you have finished setting. 2. Report print In Report screen, select [Print] to print the report. If you want to use a shortcut key for report print, you need to define the user-defined key in “Key Configuration”. For details, see Operator manual. Please refer to the accompanying manuals of the printers for more details. 3-10 System Installation 3.4.4 Video Printer The system support video printers, consist of the B/W digital printers and color digital printers. Power cable port 1. Position the printer in the proper place. 2. Plug the printer power cord into an appropriate outlet. 3. Use a USB cable to connect between the system's USB port and the printer's USB port. 4. Load a paper roll, and turn on the system and printer. 5. See section “3.4.3 Graph/Text Printer” for the driver installation procedure (printer drivers listed in chapter “2.1.4 Peripherals Supported” are installed already). Add a print service: 1. Open the “[Setup] → [Print Preset]” screen. 2. Click [Add Service] to enter the page. 3. Select the service type and enter the service name manually. 4. Click [OK] to return to the page. 5. Select the target printer from the drop-down list in the “Property” box and set other printing properties. 6. Click [Save] to complete. System Installation 3-11 3.4.5 Barcode Reader The system supports barcode reader to read the patient information (ID). Note: If the letter case displayed on the dialog box is inversed after scanning the barcode, please press the <Caps Lock> button on the control panel to toggle between upper and lower cases, and then scan the barcode again. The reader does not support Multilanguage decoding. 3.4.5.1 1. 1-D Barcode Reader The appearance of barcode reader. Each part of the barcode reader: LED indicator, scan window and scan trigger button. 1. LED indicator Green light is on if scan is successful. Red light is on if the scan fails. 2. 3. 2. Scan window Receive barcode. 3. Scan trigger button Press to perform the scan. Plug connecting terminal of the cable to the port of the barcode reader. Ensure the contact works well. Connect USB terminal of the connecting cable to the USB port of main unit. 1. Barcode reader port 3-12 System Installation 2. Connecting terminal of connecting cable 4. Press scan trigger button to receive barcode when ultrasound device is running (without installing driving program). For more operation details, see relevant barcode reader manual. 3.4.5.2 2-D Barcode Reader Install the connecting cable 1. The appearance of barcode reader. Each part of the barcode reader: LED indicator, scan window and scan trigger button. 1. LED Green: A barcode was successfully decoded. Red: A data transmission error or reader malfunction occurred. 2. Scan window Scan the barcode. 3. Trigger Press to decode 2. Plug connecting terminal of the cable to the port of the barcode reader. Ensure the contact works well. 3. Connect USB terminal of the connecting cable to the USB port of main unit. System Installation 3-13 4. Press scan trigger button to receive barcode when ultrasound device is running (without installing driving program). For more operation details, see relevant barcode reader manual. Disconnect the connecting cable 1. Using the tip of a screwdriver or some other tools with a sharp head, depress the cable’s modular connector clip. 2. Carefully slide out the cable. 3.4.5.3 JADAK Barcode Reader Supported Barcode Reader Model The Ultrasound System supports the following barcode readers: HS-1M JDK-2413 and HS-1R JDK-2601. Operating System Version If you need to use the JADAK barcode reader with the Ultrasound System, ensure that the operating system version is as follows: PC module (SOM5892-3517-M-8G) 2.0.11 or later versions PC module (SOM-6897C3-T02A1E) 3.3.13 or later versions If the version is lower than the requirements, upgrade the operating system. 3-14 System Installation For version upgrading, contact the Mindray service engineers. Select [Setup]→[About]→[About Details]→[Operating System Version] to check the operating system of your device. Setting Up the JADAK Barcode Reader (Taking HS-1R as an Example) 1. Turn off the power to the Ultrasound System; 2. Connect the appropriate interface cable to the barcode reader; 3. Plug the other end of the cable into a free USB port on the Ultrasound system; 4. Once the imager has been fully connected, power on the Ultrasound System. HS-1M JDK-2413 Configuration The barcode reader is configured through scanning the barcode. Ensure that the barcode reader is properly connected to the Ultrasound System before scanning. After the barcode is successfully scanned, the barcode reader buzzes, and the green indicator is On. Configuration before use 1. Scan the following 1-D barcode to configure the barcode reader: 2. Scan the following 2-D barcode to enable the suffix: 3. Scan the following 2-D barcode to set the suffix to Enter: Reset the barcode reader 1. If the barcode reader is in malfunction, scan the following 1-D barcode to reset to default settings. 2. Follow the configuration steps above to reconfigure the barcode reader. HS-1R JDK-2601 Configuration The barcode reader is configured through scanning the barcode. Ensure that the barcode reader is properly connected to the Ultrasound System before scanning. After the barcode is successfully scanned, the barcode reader buzzes, and the green indicator is On. Configuration before use 1. Scan the following 1-D barcode to configure the barcode reader: System Installation 3-15 2. Scan the following 1-D barcode to enable the suffix: For scanning Barcode For scanning RFID Notes: Users can customize the JADAK barcode reader based on specific requirements or contact the Mindray service engineers. This configuration guide is applicable for the Ultrasound System only. Reset the barcode reader 1. If the barcode reader is in malfunction, scan the following 1-D barcode to reset to default settings. 2. Follow the following steps to reconfigure the barcode reader: a) Scan the following 1-D barcode to configure the barcode reader: b) Scan the following 1-D barcode to enable the suffix: For scanning Barcode For scanning RFID c) Scan the following 1-D barcode to disable the prefix: For scanning Barcode For scanning RFID 3-16 System Installation 3.5 Wired Network Connection Connect the USB plug of the USB to LAN Adapter to the USB port on the machine, and insert the network cable into the LAN port of the adapter to get a wired network connection. WARNING The LAN port of the adapter CAN ONLY be used to connect to wired network. Device interconnection using the adapter through LAN port is forbidden; otherwise, electric shock may result. If you intend to connect an external device, please make sure it meets the requirement of STANDARD GB9706.15 or IEC60601-1 chapter 16. Note: the ultrasound system supports the following usb2lan devices for network connection: Manufacturer Model highspeed usb ethernet control / Anker (USB3.0 to Gigabit Ethernet Adapter) A7611 J5create (USB3.0 to Gigabit Ethernet Adapter) JUE130 uGreen (USB3.0 to Gigabit Ethernet Adapter) 20258 In case of interfering the network communication, only one usb2lan device should be connected to the system each time 3.6 System Configuration 3.6.1 Power-on Running Connect the connecting terminal of the power adapter to the adapter port in the system. Use a three-wire cable to connect the adapter with the external power supply. Ensure the connection of ultrasound and optional device works well. 3.6.2 Enter Doppler After the initialization process (about 1 minute), the system enters Doppler interface, as shown below: System Installation 3-17 3.6.3 System Preset 1. Press [Setup]. Setup menu appears. 2. Click [System Preset] to enter System Preset interface. 3-18 System Installation The following settings can be performed on the System Preset interface. Preset Interface Description Region To set the hospital name, language, time zone, system time format, system date format and system date/time. General To set patient information, exam setup, patient management, image storage, display, system dormancy, etc. Image To set some general parameters in imaging modes. Application To set the relevant information about fetal gestational age, fetal growth curve and fetal weight, etc. OB Key Config Audio Control Access Control Scan Code 3.6.4 To set the measure caliper, measure setting, follicle method, comment setting, etc. To assign functions to footswitch and the user-defined keys. To assign functions to the speech commands. To set the user account control relevant information. To set relevant information of barcode. Print Preset Press <Setup> and click [Print Preset] to set video printer, graph/text printer parameters (set the parameters according to the printer, and select the relevant printer services). System Installation 3-19 Print service setting Add Service: click to add print service. Remove Service: click to delete the selected print service. Rename Service: click to rename the selected print service. Default print service: click to set the selected print service as the default one. Set Service Property: to preset the service property, such as paper size, paper orientation, etc. set the print service according to the type. The print service include: report print, digital image print and analog image print. Image Settings Click [Image Setting] to enter the page, you can set the brightness, contrast and saturation of image printing, or you can use the default values. 3.6.5 Network Preset 3.6.5.1 iStorage Preset Select [Setup]-[Network Preset]-[iStorage] to enter iStorage interface (see the figure below): 3-20 System Installation Name Service Name IP Address Port Connect Add Description The name of the iStorage service. IP address of the iStorage service device. Port for transmitting. Click to verify connection. Click to add the Network service to the service list. Update To save the changed parameters. Delete Click to delete the selected service from the service list. Add an iStorage service 1. Set the network server properties as described above. 2. Click [Add] to add the service to the Service list. Modify a network service 1. Select the service to be updated in the service list. 2. You can see properties in the Configure Service area. 3. Modify the parameters and click [Update] to update the setting. 3.6.5.2 MedTouch/MedSight Preset You can set environment for MedTouch/MedSight here and then use the MedTouch/MedSight function by mobile phone or tablet computers. See MedTouch/MedSight manual for details. 3.6.5.3 Q-Path Overview You can use the ultrasound system to check data on browser directly. After you have ordered storage service of a network website service, you can check data using the website, authorized System Installation 3-21 account and password (provided by the service vendor).You can open the browser (Q-View) to review previously sent DICOM data. Q-path is a network server provided by Telexy Healthcare Inc. for digital image storage. Q-View is a client viewing tool for the server. Telexy Healthcare developed technology and a command structure that allows any Q-view enabled ultrasound system to access Q-path directly from the ultrasound system using a single control. The primary purpose for Q-view is to provide remote access to Q-path from the ultrasound system to complete the exam report on the ultrasound system and submit for QA, To access Q-Path on the M9 or M8 series, the user just opens the Q-View first and then enters the URL, user account and password provided by Telexy Healthcare, and the M9 or M8 series software system will call Q-View tool then for user Q-Path application. For details, please contact Q-Path service provider. Q-Path Basic Procedure Set related setting: check the check box by "Enable Q-Path" in the path: “[Setup]→[Network Preset]→ [Q-Path]”, as shown in the following: Figure 1 The preset procedures are as follows: 1. Select [Enable Q-Path]. 2. Enter the server address in the field box of "Server Address". 3. Select user type: Personal User or Default User. Personal User: the personal user needs to enter the user name and password in every-time login. Default User: after the default user enters the user name and password in the field box of the "User Name" and "Password", and click [Save], no login is required to access the Q-Path server later. 4. Select an appropriate item from the drop-down list of "Available Items" 5. Select an exam mode in the left "Exam Mode" column. 6. Select a worksheet in the right "Worksheets" column. 3-22 System Installation 7. Click [Save] to exit, and the system will shut down. Parameter Description Sets the sub URLs of "QVIew full" and "QView lite". The sub URL is set by default. Users can modify the sub URL and click [Apply] to exit the "QView sub URL setting" window. Advanced Enable Direct Report Sets whether to open the Q-Path server through pressing the <Report> key. Worksheet Only Sets whether to directly enter the Worksheet interface after opening the Q-Path server. Sets whether to display the Signature field box in a worksheet. Password Worksheet On Press <Report>→[WorkSheet] or press <Review> → [Report] → [WorkSheet], enter the worksheet password in the field box, and click [OK]. Users can query the corresponding worksheet by searching the worksheet password in the Q-Path server. Password Exam On End Sets whether to input the worksheet password after ending an exam. Password Visible Sets whether the password is visible. Import Imports a user-defined worksheet template from the USB storage (downloaded from the Q-Path server). Backup Backs up worksheets to the USB storage. Restore Restores the backup worksheet template from the USB storage to the ultrasound system. Delete Deletes a worksheet template. Restore Factory Restores the worksheet template to the default state. The operating procedures are as follows: 1. Set the DICOM storage server. 2. Send stored images or worksheet reports from iStation/Review/thumbnail area to the Q-Path server. 3. Press the user-defined key for Q-Path or press <Report> to open the Q-View browser. 4. Log in to the Q-Path server through the Q-View browser to check the stored images and worksheet reports. 5. Click [Esc] to exit the Q-View browser. Note: the following prompt will display every time you enter Q-Path after powering on the machine. Select "Yes" to enter the website service. System Installation 3-23 Figure 2 Press <ESC> or the user-defined key to exit the function. Select “Enable User Account Login” and you are able to login using single user account. NOTE: If you use the function to connect to websites other than Q-Path applications (website setting in “[Setup]→[Network Preset]→ [Q-Path]”), the system will prompt the following information: Q-Path Functions using Q-view When Q-Path is accessed from the ultrasound system using Q-view, access is restricted to the active exam and only certain functions are available. NOTE: What functions you can acquire by using Q-View is only related to what you have purchased from Q-Path service provider. Please contact Q-Path service provider for details. The primary purpose of accessing Q-path from an ultrasound machine using Q-view is to complete the exam report template and submit the exam for review or quality assurance, eliminating the necessity to log in to Q-path from a separate workstation. Q-path Functions Available on the Ultrasound System: Update Patient and Exam Information; Image Annotation; Image thumbnails; Exam Worksheets; Note: Only credentialed physicians are authorized to approve or sign a report. Submit Exam for QA. 3.6.6 Network Configure 1. Press <Cursor> to show the cursor, click manager. in the bottom bar to open the wireless network 2. Roll the trackball and press <Set> to select the target network, click [Connect] to connect to the network. When connecting an encrypted network, enter the password in the box first.You can select to hide password characters or not. 3. The system tries to connect and the wireless manager icon turns into or after successful connection. 4. Click [Refresh] to refresh the "Wireless Network Connection" list. 3-24 System Installation . The icon turns into IP Config Note: When the system background is processing network task (DICOM sending for example), please do not enter network setting to change the IP, otherwise the background task may fail. You can check if there are tasks undergoing in the task manager. IP config is used for setting local network parameters, which is also applied to DICOM connection. 1. In Wireless network manager screen, click [IP Config] to open the page: If “DHCP” is selected, the IP address will be automatically obtained from the DNS server. If “Static” is selected (using a static IP address), enter the IP address. IP address of the system should be in the same network segment with the server. Subnet Mask: set different network segment. Gateway: set the gateway IP. 2. Click [OK] to save current setting. Click [Cancel] to exit. Note: If the IP address displays as 0.0.0.0, this means that the network is abnormal. The reason for the failure may be disconnection or the system cannot obtain the IP address. EAP Network (for Windows 7 system) EAP (Extensible Authentication Protocol) is an authentification frame protocol that supports multiple authentification methods. It is mainly used for network access authentification, and is applicable for wireless enterprise security authentification. 1. In Wireless Network Connection screen, click [Eap Network] to open the page: System Installation 3-25 Import certificate: Click [Certificate Manage] to enter Certificates page, click [Import…] to import root certification in “Trusted Root Certification Authorities” page, then click [Import…] to import personal certification in “Personal” page, and set Eap network password. Set Eap network: Click [Manage Wireless Network] to set. Click [Add]->[Manually create a network profile] to set. 3-26 System Installation Network name: input Eap nerwork name; Security type: WPA2-Enterprise; Encryption type: AES; Security key: keep blank; Select “Start this connection automatically” and “Connect even if the network is not broadcasting”. Click [Next] to finish the network setting. Click [Close] to exit. Select Eap network, then press right <Set> key, and select [Properties] menu. System Installation 3-27 Enter “Security” page, select [Microsoft: Smart Cart or other certificate] from “Choose a network authentication method” drop-down list. Click [Settings], select trusted root certification from “Trusted Root Certification Authorities” drop-down list, click [OK]. 3-28 System Installation Click [Advanced Settings] to set in “Security” page. Select “Specify authentication mode”, and select “user or computer authentication” from the drop-down list. Then click [OK], close the setting page. Select Eap network in the "Wireless Network Connection" list, click [Connect] to connect to the network. EAP Network (For windows 10 system) 1. Import certificate In Wireless Network Connection screen, tap [EapNetwork] to open the Eap Network Configpage: 2. Click [Certificate Manage] to enter Certificates page, click [Import…] to import root certification in “Trusted Root Certification Authorities” page, then click [Import…] to import personal certification in “Personal” page, and set Eap network password. System Installation 3-29 1. Set Eap network: Login the system with the account of Service. Enter [Setup]→[Maintenance]→[Setup], and click [Enable ms-setting]. 2. Save the settings. The system is automatically powered off. 3. Power on the system. Enter [Setup]→[Maintenance]→[Setup]→[Enter Windows], input the password. For details about obtaining password, please refer to “6.4 Enter Windows”. 4. Open Startup menu on the Windows interface. Select [Settings]→[Network & Internet]→[Wi-Fi] →[Manage known networks]→[Add a new network], and set EAP network. Network name: input Eap nerwork name; Security type: WPA2-Enterprise; Encryption type: AES; Select “Connect automatically” and “Connect even if the network is not broadcasting”. 5. Click wireless network logo on the lower right corner of the Windows screen. Select the desired EAP network, and click [Connect]. If the EAP network cannot be connected, operate according to the prompts on the screen 6. Double-click the tool “BackToDoppler” on the desktop to return to the Doppler interface. 7. Click [Disable ms-setting] on the maintenance screen. Save the settings. The system is automatically powered off. 8. Power on the system. Select the desired EAP network on the wireless network connection menu, and click [Connect]. To remove the added EAP network, perform steps 1-3. Open Startup menu on the Windows interface. Select [Settings]→[Network & Internet]→[Wi-Fi] →[Manage known networks], select the desired EAP network, and click [Forget]. 3.6.7 Note: 1. DICOM/HL7 Preset Only if DICOM basic option is configured, [DICOM Preset] is available. Click [DICOM Preset] to enter the DICOM Preset interface. Set DICOM service attributes first: enter AE Title (use Application Entity title for ultrasound system), terminal and package size. 2. Server setting 1) Enter the device name and the IP address; 2) Verify connection after entering the correct IP address by clicking [Ping]. 3-30 System Installation 3) Click [Add] to add the server to the list if the connection works normally. The following is an example: Note: 3. 1. AE Title should be the same with the SCU AE Title preset in the server (PACS/RIS/HIS). 2. DICOM communication port should be the same with the one on the server. 3. If the currently entered name has already existed, the system will pop up: “The server name exists!” Click [DICOM Service]. When the system is configured with DICOM basic function module, and installed DICOM Worklist, storage commitment, and Query/ Retrieve modules, the corresponding preset settings can be found in DICOM Service screen. System Installation 3-31 The DICOM Service Setting is used to set properties of DICOM services. See the basic volume for details. Note: 3.6.8 Only if DICOM basic option is configured, Worklist page is available. Security Click [Security] on the Setup menu to enter the security-setting screen. 1. Drive Encryption/Secure Data Wipe Encrypt the patient data stored in the hard disk. The system provides two encryption methods: Factory Default and User Define. Factory Default: the system is in factory state by default. User Define: add a user-defined password. 1) Select [User Define]. If the patient data are already stored in the hard disk, the system prompts the following message: (if no patient data are stored in the hard disk, perform steps 5 to 6 directly) 2) Click [OK] to return to the Security screen, click [Wipe], and the system prompts the following message: 3-32 System Installation 3) Click [OK], and the system prompts the following message: 4) Click [Yes] to wipe the patient data. 5) Select [User Define] and click [Confirm]. 6) Input the password and click [Confirm] to finish the password setting. Notes 2. 1. If you want switch to Factory Default, perform steps 1 to 6 again. The password is the same as that of the User Define. 2. When you set password, multi-language and Chinese characters are not supported. Anti-Virus The system provides two anti-virus software: Windows Defender and McAfee. They can effectively prevent the ultrasound system from being attacked by virus, spyware, or other malware. If the McAfee software is installed, the system displays “McAfee is installed”; if not, the system displays “McAfee is not installed”. The McAfee software is an option. If you want to buy McAfee, contact Mindray service engineers. Notes: 3. 1. McAfee cannot be uninstalled after successful installation. 2. After installing the McAfee, disable the Fast Startup function to avoid McAfee failure. 3. McAfee can also be installed after installation of Windows Defender. 4. If McAfee is improperly installed due to power-off, shut-down, closing of cmd.exe, or any other abnormal operation during the installation, please contact the Mindray service engineers. Transmission Encryption After accessing the network, click [VPN Config] to enter the "VPN Config" interface. System Installation 3-33 Item Description No driver: click [SetupDriver] to enter the "TAP-Windows 9.21.2 Setup" interface, and do as instructed. Status Ready: the VPN is ready for use. Advance: VPN Advance Configuration Connected: VPN is successfully connected. Disconnected: VPN is disconnected. Error: error connection. Server IP Group User Name / Password Hide characters The password is displayed as *. Connect/ Disconnect Connect or disconnect VPN. 3-34 System Installation Item Description Enters the "VPN Advance Config" interface. Advance Reset: if the system does not respond after you click [Config], click [Reset]. Config: enters the "OpenConnect-GUI VPN client" interface. For details about the settings, please refer to the TAP manual. Note: after exiting the "VPN Advance Config" interface, you need to reboot the system; otherwise, you cannot connect VPN normally. Close Close the "VPN Config" interface. Note: if the system is installed with McAfee, software like VPN that is provided by the third party will be blocked. If users want to use VPN, select [Setup] → [Maintenance] → [Setup] → [Enter Windows], and input password to enter Windows. Open E:\VPNDrivers\tap-windows.exe to start installation. 3.6.9 System Information Verification Product configuration, version number, hardware board and relevant driver information appear on the system information interface. Confirm the relevant information on this interface. 1. Click [About] to enter the interface. 2. All details about the hardware board appear on [About Detail] interface. Note: 1. Confirm the system information before and after the software maintenance. System Installation 3-35 2. If required, the system reminds the user of saving the current system information. 3-36 System Installation 4 Product Principle 4.1 General Structure of Main Unit’s Hardware System TR64 Board AFE LCD Module Control Panel LCD Monitor TRB FPGA … … 64 Tx (1~64) POUT 128ch Light Sensor SATA SSD HDMI AFE I2C LVDS Power I2C Power Master Board COME Module Power Control Signal Clock CLOCK PCIE X1 WiFi PC IE X4 Backend PHV (ARM) Power DC-DC Module PHV Power Board Power Power Supply DC IN Battery Power supply mgmt. EC (ARM) System monitoring SM (ARM) Serial port Communication and control Probe Board AFE CW Module Frontend 4D&TEE 4D&TEE Signal Pencil Probe Power ECG Board AC Adapter … … 64 Tx (65~128) s Bu Data ol & Contr XCVR Probe Socket AFE TRA FPGA DSP FPGA Control POUT 64ch USB USB 3.0 X2 Control & Data Bus XCVR Power button and power indicator signal Fan Speaker Battery AC IN Figure 4-1 Schematic diagram of system hardwareThe general structure of M9’s hardware system is shown in figure above. M9 system hardware consists of each following part: Main board DC-DC circuit, which offers power supply, charges or discharges the battery. Functional circuit of back-end offers the functions of stereo audio, video audio, IO interface, etc. Signal processing FPGA. It processes the beamforming signal and occupies the functional controls except for transmitting and receiving functions. Product Principle 4-1 TRA FPGA is the FPGA which controls the transmission and the receiving. 65-128 transmitting/receiving channels. Control interfaces related to probes. 4D&TEE functional circuit implements functions of 4D drive circuit and TEE temperature measure, etc. Power supply management (EC) implements functions of the power supply management and control of starting/shutting down the main unit. System monitoring (SM) implements the power supply monitoring and fan monitoring of main system. TR64 board: 1-64 transmitting/receiving channels. Probe board connects the main unit with the probe. PHV power supply board produces the programmed high-voltage needed in the transmission. COME module, also named as PC module, runs at Doppler platform. As a main display unit, LCD module displays the image and inducts the environment brightness. ECG board offers ECG and respiratory signal acquisition and achieves the triggering function with main unit. 4.2 Main Board Main board includes: power supply, back-end and front-end. 4-2 Product Principle 4.2.1 Power Supply 2.5A Chg 4.6A Dsg Charger 2.5A Chg 4.6A Dsg Charger 19.0V/7.9A 1V DCDC 1.2V 1.5V …… Buck AC/BAT 12VBUS (12A) 2V 3.3V PWR_12V_EN_N DCDC 5VSTB(500mA) DCDC DCDC (240mA) 5V …… 3V3STB(100mA) DCDC 5VSTB_EN Figure 4-2 Principle diagram of power system Function description: It provides the power to start the device and the power when the main unit is in standby. Battery charging or discharging circuit. 4.2.2 Backend The backend is integrated with the circuit of the CPU module and main board. System monitoring SSD Wireless net adapter USB HDMI SATA FPGA PCIE USB COME module (PC module) HDMI Control panel Power button LVDS HDA USB Button, trackball Circuit control of ultrasound function PCIE Control for starting/shutting down the device Gama calibration LVDS Audio circuit LCD Speaker Power supply control Figure 4-3 Principle diagram of power system Product Principle 4-3 Function description: Circuit Unit Function The control for Starting and shutting down the device Takes charge of starting and shutting down the device and controls the indicator for starting and shutting down the device System monitoring Takes charge of battery management, fan control, voltage detection, battery indicator control, voltage detection and temperature detection Wireless net adapter WIFI and Bluetooth USB ports Provides two external USB 3.0 ports SATA port SSD, mSATA type HDMI Provides an HDMI port and supports 1920*1080 resolutions (HD) output. Audio Encodes and decodes the audio. Increases the power. Signal process FPGA Connects CPU module with the ultrasound circuit Control panel port Control panel port LCD port Connects to LCD monitor screen, displays parameter board screen and detects of environment brightness. Other circuits related to ultrasound functions Transmitting/receiving control Probe control 4D, TEE probe control (reserved function, to be released) PHV control ECG control 4-4 Product Principle 4.2.3 Front-end of Main Board Pencil probe Connect to probe via TR 64 board PEN_RX C o n n e c t o r 64ch t o Control TR 64 board Pencil Main board transmitting and receiving probe receiving switch b o a r d TX,64ch RX, 64ch Highvoltage isolation Highvoltage pulse output circuit AFE clip x8 ATGC 64ch Lowvoltage drive circuit 64ch Transmitting control C o n n e c t o r TRA FPGA Clock circuit control data t o I/Qsignal Clock CW receiving circuit Signal process FPGA 65-128 channel data b o a r d TRB FPGA Fig 4-4 Systematical diagram of front-end of main board The main functions of main board’s front-end unit: Control FPGA (TRA, implements the control of 65-128 channels transmitting and receiving, ATGC adjustment and CW receiving control). Clock circuit Transmitting circuit (transmits the pulse with the achievement of 5 electric levels) High-voltage isolation AFE (receives echo signal) ATGC circuit (time gain compensation) CW receiving circuit (CW signal receiving) Product Principle 4-5 4.3 TR64 Board PEN_TX Main board C T B Probe board C T B Pencil probe transmitting switch TR64 board CW transmitting power supply 65-128 Main board 65-128 Highvoltage pulse output circuit TX,64ch 1-64 Highvoltage isolation 64ch Drive circuit Transmitting control SPI RX, 64ch AFE clip x8 64ch TRB FPGA Clock circuit Probe control TRA FPGA Data CPU ATGC Clock offered by CPU Control signal C T B Control Signal process FPGA Fig 4-5 Principle diagram of TR64 board The main functions of TR64 board: Control FPGA (TRB, implements the control of 1-64 channels transmitting and receiving, ATGC adjustment and CW receiving control). Clock circuit provides the clock for transmitting/receiving chip. Transmitting circuit (transmits the pulse with the achievement of 5 electric levels and CW) High-voltage isolation AFE (receives echo signal) ATGC circuit (time gain compensation) Probe port function (Probe recognition signal, power supply control of the probe) 4.4 Probe Board Supports 192/128 array probe, phased array probe, bi-plane probe, and other nominal probes, etc. Implements the connection between the main unit and the probe. 4-6 Product Principle Implements the switch of 192 array probe within the probe. Probe board only supports 128th channel. 4.5 PHV Power Supply Board PHV power supply board 12VIN LC filtering P12V 12VIN LDO 11V5VCC AP100V AP100V AN100V AN100V PHV1P PHV1P PHV1N PHV1N PHV2P PHV2N UART_RX UART_TX MCU UART_RX CW_PWR_P CW_PWR_P CW_PWR_N CW_PWR_N Power supply Over current and over voltage signal DAC_CW Descending circuit Ascending circuit Sampling voltage Socket (board to board) UART_TX DAC_SDI PHV2P PHV2N Main board Flyback circuit Over current and over voltage signal LC filtering CW_VIN1 CW_VIN2 LC filtering communication &control Figure 4-6 Diagram of PHV power supply board Function description: PHV power supply board is the board that provides the power to the transmitting circuit. AP100V, AN100V, PHV1P, PHV1N, PHV2P, PHV2N, CW_PWR_P and CW_PWR_N are all outputs. PHV output goes into the power supply by producing the circuit via LDO. PHV input goes into the main board after being filtered. 4.6 ECG Unit ECG module is designed for monitoring ECG signals and displaying ECG waveforms, which serves as reference of ultrasound images. This module can synchronize with 2D images and color flow images in real-time display. With R wave detected, ECG signals, after being Product Principle 4-7 magnified, filtered and sampled, are sent to DSC nodule via series port UART. Triggered ECG signals that are detected are sent to control system for control. Then, it starts scan transmitting. ECG transducer can be connected externally in this module design, which is also compatible with other monitoring products manufactured by Mindray.ECG unit structure is shown as below: ECG Board ECG leads DC IN Pwr L T B C Magnify Filtering samp ling Socket port L T B Serial portC Heart rate test Figure 4-7 Principle diagram of ECG board 4-8 Product Principle Main Board 4.7 Control Panel Control panel unit includes two boards, as shown below: No. Board Name Description on Board Function 1 Control Panel LCD monitor folding/unfolding detection, power button, trackball, standard keys on keyboard, user-defined functional keys, backlight control, status indicator of the device, encoder, buzzer, TCG detection, etc. 2 TGC Board TCG adjustments in 8 segments Trackball module Left button of trackball Right button of trackball LED backlight ADC circuit 12V、 5V、 5V_STB Main Board TGC Board MCU FPGA SPI Button scan L T B C USB USB Power button LED backlight drive circuit Encoder info process PWM generation circuit Function button QWERTY keyboard Button Encoder Rotate System status indicator S creen closed m agnetic detection sw itch Control Panel Buzzer drive circuit Communication&control Power supply Buzzer The functional diagram of the control panel unit is shown above. The main functions are described in details. 1. FPGA module adopts FPGA and implements key scan detection, backlight control, encoder detection, buzzer control and other functions. 2. MCU module implements USB communication, TGC detection, etc. FPGA and PSOC communicate via SPI port: PSOC obtains detection result of FPGA via SPI port and sends the result to the host by USB. PSOC obtains control information from the host via USB and sends it to FPGA via SPI port. FPGA performs the control operations to corresponding units after parsing control orders. Product Principle 4-9 3. TGC board implements the fix of TCG’s sliding rheostat. 4. Trackball sub-module communicates with the host via USB. 5. Sub-module of QWERTY keyboard adopts “thin film + silicon keys + structure keys” to implement the standard keyboard. 6. Buzzer sub-unit adopts PWM waveforms that FPGA outputs to control the length and sound of volume and frequency. 4.8 Main Display Unit Test board of environment brightness 15.6" 1920*1080 LCD Monitor LTBC Parameter board LTBC 3.3V I2C +3.3V LVDS +12V LTBC LTBC 3.3V I2C Backlight control Main board socket Fig 4-8 Principle diagram of monitor The monitor unit consists of LCD screen, connecting wires, parameter board, environmental light detecting board, etc. Function description: To make the display effect of LCD screen equal to that on the parameter board, parameter board stores color temperature and gamma calibration data. It is necessary to update the parameters in control panel for first time machine assembly or control panel/LCD screen replacements. Signal processing FPGA calibrates the video signal that CPU board outputs based on the information from parameter board, and then drives LCD display screen. Brightness and power supply of LCD display screen are also controlled by this FPGA. Environmental light detecting board detects the brightness level of environment. To achieve better display effect, main unit adjusts LCD brightness level according to the environment. 4-10 Product Principle 4.9 Probe Extension Board Probe Extend Board Probe Board 260PIN probe connector A probe socket 260pin Probe control signal CPLD B probe socket 260pin Probe signal 12V/5.7V /+100V/-100V Ultrasound signal Communication &control Power supply C probe socket 260pin Probe control circuit 128 channel Transmitting/receiving signal POUT signal switch (relay set) 4D&TEE signal 4D&TEE signal switch (relay set) Figure 4-9 Hardware diagram of probe extension board Function description: Supports 192/128 array probe, 4D probe, phased array probe, bi-plane probe, and other nominal probes, etc. Implements the switch of 192 array probe within the probe. Probe board only supports 128 channels. Probe board contains three 260pin Mini probe sockets. Supports the retrieving of three probes’ IDs and the switch among three probe socket. ID recognition and the circuit of probe switch are independent to each other. Product Principle 4-11 4.10 Audio/Video Transfer Module Figure 4-10 Function of audio/video extend module Audio/video transfer board (or module) adopts non-standard HDMI input port. Main unit outputs 1920×[email protected] HDMI 1.4a signal as input signal of the extender. The module supports line-out video signal of analog stereo audio, xxxx×[email protected] analog RGB video signal, NTSC, S-Video signal with format of PAL. M9 audio/video transfer module includes: power supply, HDMI signal receiving, digital video signal processing, and audio/video code. Audio/video transfer module FPGA Video cutting, video zooming, color space change, sampling DDR2 HDMI HDMI signal receiving HDMI socket 5V Digital audio signal HDMI socket Main Unit (M9) Audio encoder S-Video Video encoder VGA Video encoder LED VGA S-Video SVideo socket VGA socket Power LED Audio Audio socket Figure 4-11 Diagram of audio/video extend module 4-12 Product Principle Communication &control Power supply 4.11 USB HUB Board Repeater/Controller USB sub-port USB sub-port USB sub-port USB main port USB sub-port Fig 4-12 Principle diagram of USB HUB board The main functions of USB HUB board: Compatible with the USB 2.0 standard; One USB port can be subdivided for four USB ports (there are two ports in current products.) Detect the plug and unplug of USB device via main port. Charge the device connecting to USB via main port. 4.12 Trolley Power Supply Trolley power supply provides the power to main unit system. AC-DC power supply provides the power to main unit system when there is AC input. If there is no AC input, trolley power supply provides the power to main unit system. Trolley power supply includes connecting board of trolley power supply, AC-DC power supply, management board of trolley battery and two pieces of chargeable lithium-ion batteries. The connection of each part is shown below: Product Principle 4-13 Indicator signal J5 Power supply and signal of Battery battery A A Power supply and signal of Battery battery B B Power supply and its status indicator J6 Relay control signal J4 Connecting board of trolley power supply J3 J4 AC IN J1 AC OUT J2 J2 Mgmt board of trolley power supply AC IN J1 J3 J1 EDC_19V J2 AC-DC power supply J3 Fan power supply Fan Figure 4-13 Diagram of related boards of trolley power supply 4.12.1 Connection Board of Trolley Power Supply Main functions of connection board of trolley power supply: AC input transfer Auxiliary output control. Auxiliary output is enabled after starting main unit. Auxiliary output disconnects when main unit is in standby or shuts down. 4.12.2 AC_DC Power Supply AC_DC power supply implements power supply isolation and voltage transfer. It outputs 19 V DC transferred from AC input. In terms of 150 W of main unit power and 50 W charging power, the maximum power of AC_DC power supply is 200 W. 4.12.3 Management Board of Trolley Battery The main functions of management board of trolley battery: Implements AC power supply and auto switch of battery supply. AC power supply has the priority over others. Battery charge and battery management; AC status and battery status indication; Works with main unit system and recognizes the status of main unit system. Implements auxiliary output control and low battery-consumption when the trolley is in standby. 4-14 Product Principle Principle diagram of management board of trolley battery is shown below: Figure 4-14 Diagram of management board of trolley battery 4.13 System Power-on Control Function circuit CPU module S3# Control panel Power button S4# POWER _OK Control for starting/shutting down device 5VSTB Enabling power supply 3V3_STB 12V Multichannel power supply DC-DC Figure 4-15 System power-on diagram Description of related controlling signals: No. Controlling signal Description 1 PWR_BTN_N, Pulse signal that power-on button of control panel produces passes to CPU board through FPGA, and is used for starting the device. PWR_BTN# Comme nts 2 S3# Output by CPU board, effectively represents that CPU system is in standby (the electrical level of S4# is high) and keeps 5VSTB powered on when it is in standby via FPGA. 3 S4# Output by CPU board, effectively represents that CPU system is in dormancy. 4 S5# The signal is not used currently Product Principle 4-15 5 PWR_OK# Sent out by power management FPGA to CPU board, indicates that the 12V is powered on. Power supply of main unit/battery enables the start of device. Power supply produces 5VSTB and 3.3VSTB as the AC inputs. Unplug AC when shutting down the device. Power supply cuts off 5VSTB output, but only keeps the output of 3.3VSTB. Only with power button pressed again, it’s re-powered on. Unplug AC when the device is in standby. Batteries, for standby usage, provide the output of 5VSBT and 3.3VSTB. The process of power-on is shown below: Connect to AC Press power button (control panel) Receive valid PWR_BTN_N (power supply mgmt FPGA) Power supply mgmt sends valid PWRBTN# signal S3# and S4#invalid (COME module sends) DC-DC 12V power-on PWR_OK valid (power supply mgmt sends) CPU start (COME module) Figure 4-16 Diagram of system power-on 4-16 Product Principle DC-DC board sends power supply of other circuits 4.14 Internal Connection Diagram of Main Unit and Trolley Wire Main unit LCD Monitor Light sensor board LCD parameter board J1 J1 Board to board socket Board Wire to wire socket Board to wire socket Power supply wire material Signal wire Reservation material design SSD mSATA port COME module WiFi module J17 Power supply adapter 2*2* 110 Mini PCIE J9 J4 Fan assembly mSA TA J23 J5 Audio/video transfer module 2*78 J1 J8 J3 Probe board J12 J1 TR64 board Main board J6 2*60 J18 J7 J22 J20 J21 2*20 J10 J15 J2 260 PIN J1 6*40 J18 J24 J3 1*8 1*8 J1 PHV power supply board J4 Battery Trackball J6 Battery Buzzer ECG boardJ5 J3 TGC board ECG connecting board J2 USB HUB board J11 Control panel J1 J6 J5 J1 Speaker assembly Trolley LED board 2*40 Probe connecting board 1PCBA 2*40 Probe connecting board 2PCBA Probe extend module J1 2116 small keyboard J2 AC-DC module 2*20 Probe extension wire A probe connecting board PCB 260 PIN M9 probe extender B connecting probe M7 probe extender 4DConnecting board PCBA AC output J6 Battery 1*11 J2 J5 J7 J10 J2 Trolley battery management board Battery 1*11 J3 J1 Connecting board of trolley power supply J4 J4 J3 AC input Trolley Fig Figure 4-17 Internal connection diagram of main unit and trolley 4.15 Details in Main Unit’s Power-on Start-up procedure of main unit and the performance of power supply & display in various steps are shown below: Product Principle 4-17 AC is activeà Active AC indicator,green, lighting Battery supplyà battery status indicator, green,lighting Press Power Button No sign on screen EC ARM receives signal Effective power-on N Exit, without starting Y Work status (below Power Button),green,blinks Enabling CPU_PWR_BTN COME module receives signal COME module sends S3, and starts power-on flow Work status indicator (below Power Button), green, lighting EC ARM receives S3 signal EC ARM enables power supply of main unit EC ARM delay EC ARM sends PWR_12V_OK order COME module receives PWR_12V_OK COME module, start BIOS COME module, output boot screen Hard disk indicator, green, blinks Power supply power-on 1Và… … 5V 12V Control panel FPGA configuration Control panel power-on DSP FPGA(PCIE device)start configuration Control panel PSOC BOOT DSP FPGA(PCIE device) complete configuration Initialize control panel (white backlight is on) DSP FPGA(PCIE device) in nonreset status Control panel ready Initialize display. Turn off backlight. Do not output LVDS signal No sign on monitor Open DSP FPGA Open LCD backlight, adjust brightness Backlight of monitor brightens. No display DSP FPGA sends LVDS data to LCD Correct image displays on monitor(BIOS boot screen) COME module, complete BIOS No sign on monitor Start loading OS Display changes of resolution LOGO (MINDRAY) displays on monitor Complete OS loading No sign on monitor Adjust final resolution Image from desktop displays on monitor Enter OS desktop Start Doppler 4-18 Product Principle Doppler start screen displays on monitor 5 Checking Performance and Functions 5.1 Description The chapter describes checking methods to main functions and performance. The methods are only for reference. 5.2 Checking System Status 5.2.1 Running Status 1. Power on/off normal (duration time is normal), no abnormal sounds or occasion occur during normal operation. 2. After ultrasound system gets started, the fan starts working, and no abnormal noise is heard when the fan is working. 3. Check whether product configurations and software versions are normal via [About] interface. 4. Check whether contrast and brightness of the monitor are normal. 5. Check whether time and date are valid and correct. 6. Check whether all status indicators are normal. 7. Check all log records together with the users to confirm whether there are any abnormalities. 5.2.2 Working Condition Check the ambient temperature and humidity. The measurement related to security features is sensitive to humidity. If the insulation feature of the system deteriorates due to the increase of system service time or system malfunctions, the fluctuation range of measurement results are likely to increase with the humidity increasing. Checking Performance and Functions 5-1 5.3 General Check 5.3.1 Check Flow Check the control panel Check the monitor Check peripherals Check ECG Check I/O port 5.3.2 Check Content 5.3.2.1 Check Control Panel Procedure 1. Check all buttons, keys and knobs Checking criteria All keys and knobs are effective. Follow the direction: left to right, and up to down. 2. Trackball function check Press <Freeze> to enter frozen status and move the trackball. Press <Measure> to enter measurement status. Measure the vertical distance and horizontal distance and perform other trackball operations. 5-2 Checking Performance and Functions The move of the trackball is smooth. The response to the cursor is rapid. The direction the trackball goes is same with that of the cursor. 5.3.2.2 Check Monitor Procedure Monitor brightness adjustment Monitor contrast adjustment Monitor maintenance Log on with the account named as “Service”, select [Setup]-[Maintenance]-[Test Main Monitor] to check the monitor functions. Checking criteria Height adjustment: Auto adjustment: select [Setup]-[System Preset]-[General]. Click [Brightness Auto Adjustment] from [About]. Manual adjustment: press <Fn>+< > to increase the brightness. Press <Fn>+< > to decrease the brightness. Select [Setup]-[System Preset]-[General]. Click [+] from [Contrast] to increase the contrast. Click [-] to decrease the contrast. The monitor display works well after testing each function. Bad points are: 1 Light dot is 0; blinking dot defect is 0. 2 The adjoining dark dots are no more than 3 pairs, and there are no adjoining dark dots in image area. 3. 3 or 3 successive dark dots are no more than 0 pair. The dark dots are no more than 7 and those in the image area are no more than 2 5 The distance between bad dots is no less than 5mm. Note: the image area refers to the area enclosed by the rectangle with black/white background. Checking Performance and Functions 5-3 5.3.2.3 Checking Peripherals Procedure Checking criteria Footswitch: confirm the normal connection between footswitch and USB port. Check the configuration status of footswitch under [Key Config] and corresponding implementation. (E.g. right key-image freeze; middle key-color print; left key-white/black print). Trigger the freeze key of the footswitch (right key). Image freeze menu and freeze menu appear. The image is unfrozen if the key is triggered again. Trigger the print key of the footswitch (middle key). Start color print. Trigger the print key of the footswitch (left key). Start black/white print. Video printer: confirm the connection between video printer and ultrasound device works well and check the implementation of each function. Press the Print key which is setup well already to start the print. The image has no defect or degradation. Graph/text printer: confirm the connection between graph/text printer and ultrasound device works well and check the implementation of each function. Press the Print key which is setup well already to start the print. The image has no defect or degradation. Barcode reader: scan any piece of barcode when the system is under running. The barcode information displays on the image interface. The information is correct compared with the data information of barcode. 5.3.2.4 Switch video output terminal. Then repeat the previous steps. Checking ECG Module Procedure Perform the following tests after the system is configured with ECG module: Connects ECG lead. Move the cursor to image menu. Click [Physio] to enter its interface. 5.3.2.5 Checking criteria ECG activation, ECG waveform and heart icon appear on the right corner of the interface. The parameters for [Scan speed], [ECG gain] and [ECG position] can be adjusted in real-time. Review ECG signals. Checking I/O Interface Procedure Checking I/O interface Checking criteria The information on VGA/LCD monitor is same with that on the screen of main unit. The characters and images are complete; the images are stable; no color cast; no shaking and no blinking. Network connection and communication work well. USB storage and read work well. Verify video/audio interface, USB port, etc. VGA interface Connect external VGA/LCD monitor (the resolution should be one of them: 1920*1080,1024*768, 1280*1024,1280*720). Other USB ports 5-4 Checking Performance and Functions 5.4 Functions Checking Note: 5.4.1 The chapter lists the system checking items with complete configurations and describes them in details. If the items are not configured, the relevant tests can be ignored. Checking Flow Check image mode Check basic measurement Check cine mode Check probe usage Image and imaging management Record and save the check 5.4.2 Checking Content 5.4.2.1 Imaging Mode B-mode In B mode scan, the image parameter area in the upper left corner of the screen displays the real-time parameter values as follows: Items F D G FR DR iClear iBeam iTouch Meaning Frequency Depth Gain Frame Rate B Dynamic Range Display when the function is activated. Parameters that can be adjusted to optimize the B Mode image are indicated in the following. Adjustment Parameter Item Control panel and image soft menu adjustment Frequency (image quality), gain, depth, TGC, acoustic power, focus, scan range, steer, ExFov, line density, dynamic range, iClear, persistence, rotation/invert, iBeam, auto piecing, gray map, tint map, TSI, iTouch, HScale, dual live, LGC, Echo, Boost. Checking Performance and Functions 5-5 Parameter Adjustment Procedure Checking criteria Press <B> button. Enter B mode image. B mode interface appears. Frequency adjustment B image soft menu-[Image quality] The real-time value of frequency is displayed in the image parameter area in the upper right corner of the screen (fundamental wave-F, Harmonic frequency-H). Values of frequency vary depending upon the probe types. Gain adjustment G Gain increases with rotating the knob clockwise; Rotate <Gain> button Gain decreases with rotating the knob anticlockwise; Depth adjustment D The depth of the image changes accordingly. Depth range varies depending upon the probe types. Press <Depth> button. TGC adjustment Adjust 8 sliders on the control panel Push the slider right to increase the gain. The brightness of the area becomes brighter. Push the slider right to decrease the gain. The brightness of the area becomes darker. About 1.5s after the adjustment is finished, the TGC curve disappears. Acoustic power adjustment The system offers 34 values to adjust the acoustic power. B image soft menu-[Acoustic power]. Acoustic power (AP) is displayed in real time in the upper part of the screen. Focus B image soft menu-[Focus number] Press <Focus Position> to adjust focus position. Focus position/number adjustment The focus position icon image. is displayed on the right side of the Scan range and FOV position Image display adjustment B image range]. [Scan range] is on and move the trackball to adjust the scan range. soft menu-[Scan Steer Press <Steer> arrow button. ExFov B image soft menu-[ExFov] Line Density B image Density]. To steer the beam the probe transmits. Click [ExFov] on the soft menu to enable/disable the function. The function determines the quality and information of the image. soft menu-[Line Dynamic Range B image soft menu-[Dynamic Range]. iClear B image soft menu-[iClear]. Levels of line density: UH/ H/ M/ L. Rotate the knob clockwise to increase dynamic range; rotate the knob counterclockwise to decrease dynamic range. The adjusting range of parameter is 30-180 dB in increments of 5 dB. The system provides 7 levels of iClear effects adjustment, Off represents iClear is disabled, and the bigger the value is the stronger the effect becomes. 5-6 Checking Performance and Functions Persistence B image menu-[Persistence]. soft Rotation/Invert B image soft Flip]/[U/D Flip]. The system provides 7 level of persistence. The bigger the value is the stronger the effect becomes. To invert the image horizontally or vertically. menu-[L/R Image can be rotated by the angle of 0°, 90°, 180° and 270°. When the image is rotated in the angle of 90° or 270°, the depth scale is displayed on the upper part of the screen. The “M” mark indicates the direction of the image; the M mark is located on the top of the imaging area by default. iBeam B image soft menu-[iBeam]. Auto Merge B image Merge]. soft menu-[Auto The system provides 4 values of iBeam in B mode. iBeam is disabled when it is off. In the Dual-split mode, when the images of the two windows have the same probe type, depth, invert status, rotation status and magnification factor, the system will merge the two images so as to extend the field of vision. Turn on or off the function through the [Auto Merge] item in the soft menu; Gray Map Adjust the gray from [Gray Map] on the soft menu; B image soft menu-[Gray Map] There are 8 different maps available. Tint Map Select the tint map from [Tint Map] on the soft menu. B image soft menu-[Tint Map] Turn on or off the tint map from [Tint Map] on the soft menu. TSI Select TSI from [TSI] on the soft menu. B image soft menu-[TSI]. The system provided 4 ways of optimization for specific tissues: general, muscle, fluid and fat. iTouch Press <iTouch> on the control panel to enter the iTouch status, the symbol of which will be displayed in the image parameter area of the screen. Press <iTouch> button Click [iTouch] on the image menu to adjust the gain in iTouch status among -12 through 12dB. Long press <iTouch> to exit iTouch mode. HScale Click [HScale] on the menu to display or hide the scale (HScale). B image soft menu-[HScale] Dual live B image soft menu-[Dual live]. Enable [Dual Live] on soft menu, and dual-split window of images are displayed on the screen. Two pages of adjustable parameters are displayed on the touch screen as well; where, shared parameters and left window parameters are displayed on the B(L) page, while right window parameters are displayed on the B(R) page. Switch the display mode via <Switch Mode> and adjust the image parameters. Checking Performance and Functions 5-7 LGC Images corresponding to four groups of parameters are displayed on the soft menu (from left to right). B image soft menu-[LGC]. Click [LGC1-5] to adjust the parameters. To each segment of image area, the system offers 5 values to adjust the gain. The gain increases with the value becoming bigger. In addition, the system provides several preset parameters for imaging. Echo Boost B image Boost]. soft menu-[Echo [Echo Boost] is enabled when it is on in B mode.(Highlighted) the system is in “Echo Boost” status. M mode In M mode scan, the image parameter area on the right side of the screen displays the real-time parameter values as follows: Parameter Item F D G V DR Meaning Frequency Depth M Gain M Speed M Dynamic Range Parameters that can be adjusted to optimize the M Mode image are indicated in the following. Adjustment Parameter Item Control panel and soft menu adjustment Gain, TGC, Depth, Focus Position, Display Format, Line Correlation, Tint Map, Scan Speed, Edge Enhance, Dynamic Range, Gray Map. Color mode In Color mode scan, the image parameter area on the right side of the screen displays the real-time parameter values as follows: Parameter Item Meaning F G WF PRF Frequency Color Gain Color Wall Filter Pulse Repetition Frequency Parameters that can be adjusted to optimize the Color mode image are indicated in the following. Adjustment Control panel and soft menu adjustment Parameter Item Gain, Depth, TGC, Steer, iTouch Image Quality, Scan Density, Persistence, Smooth, Sensitivity, B/C Wide, Velocity, Flow, Wall Filter, Steer, B/C dual live, Caliper, Color Map, Color Priority, Baseline, HR Flow. Power mode In Power mode scan, the image parameter area on the right side of the screen displays the real-time parameter values as follows: Parameter Item Meaning F G WF PRF Frequency Power Gain Power Wall Filter Pulse Repetition Frequency Parameters that can be adjusted to optimize the Power mode image are indicated in the following. Adjustment Parameter Item 5-8 Checking Performance and Functions Adjustment Parameter Item Control panel and soft menu adjustment Gain, Map, Dynamic Range PW / CW Mode In PW/ CW mode scan, the image parameter area on the right side of the screen displays the real-time parameter values as follows: Parameter Item Meaning F Frequency G WF PRF SVD Gain Wall Filter Pulse Repetition Frequency SV Position SV SV Size (Only for PW mode) Angle Angle Parameters that can be adjusted to optimize the PW/ CW mode image are indicated in the following. Adjustment Parameter Item Control panel and soft menu adjustment Gain, SV, Depth, Image Quality, Caliper, iTouch, Auto Calculation, Invert, Scan Speed, T/F Res, WF, Tint Map, Gray Map, Display Format, Duplex/Triplex, HPRF, Baseline, Angle, Quick Angle, Dynamic Range, Volume, Steer. 5.4.2.2 Basic Measurement Procedure B mode: Checking criteria Enter application measurement mode Enter general measurement mode Press <Measure> button Press <Caliper> button Measure 1-2 items (such as length, area). The calculation result is displayed at the bottom of the image in real-time. Press the same button or press<Esc>. Exit the corresponding measurement. Similar operations for other modes Application measurement options agree with various application software packages. Checking Performance and Functions 5-9 5.4.2.3 Cine Review Procedure Checking criteria Press <Freeze> to freeze the image. The system enters manual-review. (Precondition: Set “Enter in frozen status” to “Cine”. Open cine files in thumbnail, iStation or Review. The system enters automatic cine review status. Enter Cine Review status The system enters auto review status. Roll the trackball Manual cine review Click soft menu-[Auto Review] Start auto review. Adjust soft menu knob to change the speed of cine review. Review speed gets faster with the value becoming bigger. Review speed gets slower with the value becoming smaller. If the review speed is 0, it exits auto review mode Move the cursor to the start point to review (or image frame), and then click soft menu of image [Set as Start Point]. Set start point of auto review. Move the cursor to the end point to review (or image frame), and then click soft menu of image [Set as End Point]. Set end point of auto review. Click soft menu-[Auto Review] again. The cine review plays between the start point and the end point. Press <Freeze> to defreeze the image again. Return to scan status with the image defreezing and exit cine review. Auto play area Total frame number Start point of auto review Review progress bar Current frame number End point of auto review 5.4.2.4 Probe Switch and Recognition Procedure Checking criteria Press <Freeze> button – plug the probe – press <Freeze> button – press <Probe> button. Ultrasound device can be recognized while connecting the probe. Press <Freeze> button – unplug the probe – plug a new probe. Recognize the probe type instantly. 5-10 Checking Performance and Functions 5.4.2.5 Image and Imaging Management Procedure Checking criteria Press <Save> in scan process (set based on the preset) Save B mode image to patient data library in real-time. The icons of the images appear on the right side of the interface. Select [Setup]-[System Preset]-[General]. Select “Exam Setting” from “Sending/Printing after End Exam”. The system sends the image to the default DICOM server or printer server automatically. Press <End Exam> in scan process. Press <Review> button To enter Review Click [Close] button on the review interface; or press <Review>/<Esc> to exit the interface. To enter Review Press iVision ([Setup]-[System Config]-[Others]). Enter iVision screen Start image demonstration user-defined button Preset]-[Key iVision interface. Add the demonstration item, and select display method. Select a demo from the list, and then click [Start]. Click [Exit] or press <Esc> to exit after the demonstration finishes. Press <iStation> to enter patient information management interface. 5.5 Performance Test 5.5.1 Test Procedures Image files are played according to file names one by one (including the image of system-relevant and PC-compatible format). Exit the image demonstration Agree with patient’s ID. View the real-time image/imaging information. The following operations are also available: Back up (Restore) Send (DICOM, USB flash disk, etc) Check resolution Check detection depth Check geometric positioning accuracy Blind area test Record the imaging Checking Performance and Functions 5-11 5.5.2 Note: Test Content The following figure is only used for reference in the testing, and the actual image effect depends on the specific system. Requirements: 1. Display: set the brightness and contrast values to clinical (or default) status; 2. Ambient: dark room to simulate actual clinical using; 3. The probe surface should contract with the acoustic window without separation or pressing. Description: Refer to <Appendix B Illustration or Phantom Using> for the phantoms used in the test. Phantom KS107BD, low frequency, used when center frequency of the probe ≤ 4MHz; Phantom KS107BG, high frequency, used when center frequency of the probe ≥5MHz; 5.5.2.1 Resolution Lateral resolution Test Procedure: 1. Place the probe head gently on the acoustic window of the phantom which is covered by water or gel, and make sure the lateral resolution targets are displayed in the center of the image. 2. Focus to the lateral resolution target group. 3. Adjust gain, dynamic range, TGC, etc., make sure only the target line is displayed clearly on the image with no tissue image in the background. 4. Read the separation between two target points that can be distinguished clearly, while keeping the transverse target group horizontal. 5. Repeat upper steps at other depth. Image effect is show in figure below: Axial resolution Test Procedure: 5-12 Checking Performance and Functions 1. Place the probe head gently on the acoustic window of the phantom which is covered by water or gel, and make sure the axial resolution targets are displayed in the center of the image. 2. Focus to the axial resolution target group. 3. Adjust gain, dynamic range, TGC, etc., make sure only the target line is displayed clearly on the image with no tissue image in the background. 4. Read the distance between two target points that can be separated clearly. 5. Repeat upper steps at other depth. Note: 1. 2. 5.5.2.2 For convex probe, keep the lateral resolution targets near the central line of the scanning plane. For linear probe with Steer function, DO NOT turn on Steer when testing the transverse resolution. 3. Magnify (zoom) the targets for observation if necessary. 4. Distance between the left and right edges of a target point at a certain depth indicates the transverse resolution at this depth also. Maximum Detection Depth Test Procedure: 1. Place the probe gently on the phantom surface which is covered by water or gel. 2. Set displaying depth (according to the max depth of the current probe); 3. Adjust Focus to the deepest value, set AP value to largest. 4. Increase Gain, Contrast, TGC, but make sure no halos or defocusing appears. 5. Record the depth of the most distant target line which is imaged clearly. Note: 1. 2. 3. An overlarge gain may result in large noise and submergence of the echo signal. For linear probe, the probe surface should be perfectly fit with the acoustic window on the phantom without any inclination during scan. For convex and phased probe, make sure the axial target group is placed in the central of the scanning plane which keeps the justice of the interfering effect. Checking Performance and Functions 5-13 4. In non-frozen mode, a distant target may be similar to a noise dot which should be discarded. Image effect is show in figure below: 5.5.2.3 Geometric Positioning Accuracy Axial Geometric Positioning Accuracy Test Procedure: 1. Adjusting steps are the same with the Maximum Detection Depth. 2. Record the separation values with measuring caliper in step of 20 mm on the axial target group. 3. Select all measurement values deviating largely from 20 mm, and calculate the error by the following formula. 5-14 Checking Performance and Functions Note: 1. 2. Measuring cursor should be placed on the top edge of the target image, not in the middle or bottom edge. Scan plane should be perpendicular to each target line, in other words, scan plane should be parallel to phantom section plane. Image effect is show in figure below: Lateral Geometric Positioning Accuracy Test Procedure: 1. Place the probe gently on the acoustic window of phantom which is covered by water or gel. 2. Adjust display depth, to make horizontal groups display in the image. 3. Adjust focus to be in horizontal groups (no explicit standard). 4. Adjust gain, TGC, etc to make horizontal groups display clearly. 5. Use caliper to measure horizontal target distance by step of 20mm. 6. Select all measurement values deviating largely from 20 mm, and calculate the error by the following formula. Note: 1. To linear array probe, read the lateral distance one segment after another. 2. For convex probe, display all lateral targets one time. 3. The measurement caliper lies at the top or bottom of the target to be measured. Image effect is show in figure below: Checking Performance and Functions 5-15 5.5.2.4 Blind Area Test Procedure: 1. Place the probe gently on the phantom surface which is covered by water or gel. 2. Adjust the depth to lower value and set the focus to shallowest. 3. Reduce AP, Gain, etc until the background noise is barely visible. 4. Observe the depth of shallowest target image. It is also the blind area value. Note: 1. 2. For linear probe, the probe surface should be perfectly fit with the acoustic window on the phantom without any inclination during scan. For convex probe, blind area target in the observation must lie on the central line of the scan plane. Image effect is show in figure below: 5-16 Checking Performance and Functions 6 6.1 Note: Software Installation & Maintenance Enter Maintenance Before the maintenance operation, the engineer should login the system as Service. After clicking [Enable ms-setting], you can make settings for the operating system on Windows interface. After the settings, click [Disable ms-setting] on the maintenance screen to disable the function immediately. Otherwise, the performance or operation of the ultrasound system may be affected. Log-in: 1. When Access Control is disabled: press “ctrl”+“/” to pop up the Login dialogue box, select Service as the user name and input the password. 2. When Access Control is enabled, press “ctrl”+“/” on the login dialogue box to show the inner users, select Service and input the password to login. 3. Log in with the account of Service and enter maintenance screen by selecting [Setup] > [Maintenance] > [Setup]. Software Installation & Maintenance 6-1 6.2 Software Installation/Restoration See Software Recovery Guide for detailed system operations and Doppler system restoration. WARNING: 1. To avoid data loss, back up user’s preset data and patient data before system restores. 2. Do Not cut off, shut down or restart the system in the restoration. 6.3 Activating Windows 10 Operating System NOTE: After OS is upgraded from Windows 7 to windows 10 or Windows 10 is recovered, Windows 10 needs to be activated. 6.3.1 Online Activation Make sure the ultrasound system is connected to the internet. Perform the following procedure: 1. Go to [Setup] > [Maintenance] > [Setup] > [Enter Windows], and input the password. For details about obtaining password, please refer to "6.4 Enter Windows". 2. Input “Control Panel” in the address column in the pop-up Windows Explorer and press [Enter] key to display Control Panel. 6-2 Software Installation & Maintenance 3. Select [System and Security], and then press [System]. 4. If Windows 10 is not activated, close all the windows to return to the ultrasound screen. 5. Enter service mode, please refer to “ 6.1 Enter Maintenance”. 6. Navigate to [Setup] > [Maintenance] > [Setup] and click [Enable ms-setting]. 7. Select [OK] > [Save] to exit and power off the system. 8. Power on the system. And redo the step 1 ~ step 3. 9. Click [Activate Windows]. It may take a while to activate Windows. After it is successfully activated, “Windows is activated” will be displayed on the screen as shown below. Software Installation & Maintenance 6-3 10. Close all the windows and run “BacktoDoppler.exe” on the desktop to return to the ultrasound screen. Navigate to [Setup] > [Maintenance] > [Setup] and click [Disable ms-setting]. 11. Select [OK] > [Save] to exit and power off the system. 6.3.2 Phone Activation If the ultrasound system is not connected to the Internet, activate Windows 10 by phone. Perform the following procedure: 1. Go to [Setup] > [Maintenance] > [Setup] > [Enter Windows], and input the password. For details about obtaining password, please refer to "6.4 Enter Windows". 2. Input “cmd” in the address column in the pop-up Windows Explorer and press [Enter] key. 3. Input “slui 4” in the DOS prompt and press [Enter] key. Phone activation wizard Menu will be displayed as below. 4. Select your country or region, and click [Next] to continue. 6-4 Software Installation & Maintenance 5. Call one of the phone numbers displayed on above. Choose the proper option number according to the voice prompts, and enter the Installation ID. Then write down the Confirmation ID according to the voice prompts. 6. Click [Enter confirmation ID] to enter the following menu. 7. Input the Confirmation ID, and click [Activate Windows] to finish the activation. 6.4 1. Enter Windows The password is generated by device Mac address and serial number (see System Information), please contact Mindray Service Department for details. 2. Enter maintenance menu. Click [Enter Windows]. Type the password to enter Windows system. Software Installation & Maintenance 6-5 6.5 Software Maintenance 6.5.1 Log Export 1. Insert the USB disk to the device; 2. Enter [Setting] interface; select [Export Log] to export the log. 3. Select the path in the Browse page to save the log, and then click [OK]. 4. When the log is exported, the system prompts “Export succeed!”, click [OK] to return to Maintenance menu. Note: The log can be exported to the external USB storage device only. Make sure there is enough space for the storage before the exporting. 6.6 Data Backup and Storage 6.6.1 Preset Data Management Select [Setup]-[Maintenance]. Export and import system preset data or load the factory. 6.6.1.1 Back up the Setup Data 1. Click [Export] to open the [Export Data] dialogue box on [Preset Data Management] interface. 2. Select the path to save data. 3. Click [OK]. A progress bar appears and the setup data of the selected item is exported to the specified path. 6-6 Software Installation & Maintenance 6.6.1.2 1. Restore the Setup Data Click [Export] to open the [Export Data] dialogue box on [Preset Data Management] interface. 2. Select the path to import the data. Select path to import all data or some of the data; 3. Click [OK], a progress bar appears and the setup data is imported to the specified module. Tip: If select [Load Factory], the settings are restored to the factory defaults, except for region preset and admin. 6.6.2 Patient Data Backup and Restoration 6.6.2.1 Patient Data Backup 1. Press [iStation] on the control panel to open the iStation dialogue box; 2. Click [Select All] to select all data or select the desired data one by one; 3. Select the information. Click [Backup Exam] to pop up the “Backup Patient Record” dialogue box. Select the desired storage device (recorder, DVD or USB disk). Click [Backup]. Back up the selected data automatically. 4. Select whether to encrypt backup exams for USB only, input the password, confirm password in the field box, and then click [Backup], A "Patient.7z" compressed package is backed up to the USB device Note: You need to input the password to open the package. If the password is forgotten, you cannot open the backup package. 6.6.2.2 Restore Backup Patient Data 1. Press [iStation] on the control panel to open the iStation dialogue box; 2. Select the drive which contains the patient data. Click [Select All] to select all the data or select the target data one by one. Click [Restore] to restore the patient data from the current drive to the patient database. 6.7 1. Introduction on HDD Partition Data The whole capacity is 128 G. The details are shown as follows: Notes Blocks(G) Notes C: 30G NTFS D: 84G NTFS E: 5.13G NTFS 2. Data distribution in each drive is shown as follows: a) D drive Data directory of Drive D D:\M9 Data Description \StressEcho \UserProtocolTemplates StressEcho Protocol Template \gui \word User-defined library \PATIENTDATA \ Patient database path \Preset \Current User preset data Software Installation & Maintenance 6-7 \temporary \ Temporary file directory \ScreenSaver Screensaver \crash Dump file directory \DICOMRevFiles Temporary file backed up by DICOM \Log Log file \DcmLog DICOM log Userconfig b) User information file E drive Directory structure of saved data in E Drive. Data Description E:\M9 PatientBack Patient data backup E: \Demo Demo file 6-8 Software Installation & Maintenance 7 Field Replaceable Unit This chapter lists the details of the Field Replaceable Units (FRU) of the system. Please refer to the explosive view and the FRU table below. Level 0 represent the main assemblies of the system, and the whole system is divided into 6 assemblies. Level X represent the main parts of Level 0 assembly. Level X-1 represent the sub-parts of Level X. If order number is provided in the table, which means the part is a FRU and can be ordered; if the order number is not provided in the table, which means the part is not a FRU and cannot be ordered. Field Replaceable Unit 7-1 7.1 Explosive View A0 F0 B0 C0 7-2 Field Replaceable Unit 7.2 Assembly Explosive View 7.2.1 Monitor Assembly (A0) A1-2 A1-1 A1 No. Order Number 115-048328-00 A1 115-048329-00 Part Name Qty. Remark Monitor Assembly (eDP screen/FRU) 1 eDP signal, for repairing new M9(SN starts with CC1,CC2,CC3, CC4,CC5) only Monitor Assembly (LVDS2eDP/FRU) 1 LVDS to eDP signal, for repairing old M9 (SN starts with 7B, 7C,7D,8K,CAW) only Field Replaceable Unit 7-3 No. Order Number 115-056405-00 Part Name Qty. Remark Monitor assembly(M8 Series/FRU) 1 For M8 series only A1-1 115-016997-01 Monitor front assembly 1 For both M9&M8 series A1-2 115-023075-01 Monitor rear assembly(FRU) 1 For M9 series only 115-056406-00 Monitor rear Assembly (M8 Series/FRU) 1 For M8 series only 7-4 Field Replaceable Unit 7.2.2 Control Panel Assembly (B0) B5 B4 B3 B2 B1-5 B1-4 B1-7 B1-2 B1-3 B1-1 B1 B1-6 No. B1 Order Number Part Name Qty. Remark 115-023071-03 Control Panel Assembly(FRU) 1 For M9 series, not including trackball, small PC keyboard, and TGC board. 115-055540-02 Control Panel Assembly(M8 Series/FRU) 1 For M8 series, not including trackball, small PC Field Replaceable Unit 7-5 keyboard, and TGC board. B1-1 044-000368-00 M9 key top cover 1 B1-2 043-003279-02 Large encoder key(Quick Angle) 1 B1-3 043-003283-00 Large lens(Baseline) 1 B1-4 043-003582-02 Large encoder knob(iTouch, Quick Angle) 2 B1-5 043-003583-02 Small encoder knob(zoom) 1 B1-6 049-000559-01 Silicon keypad 1 B1-7 801-2300-00008-00 Buzzer(FRU) 1 023-000706-00 Track ball 1 Not include the connecting cable. 115-060585-01 2116 PC Keyboard 1 For human use 115-060586-01 2116 PC Keyboard(FRU/ Russian) 1 For human use, Russian 115-065681-00 2116 PC Keyboard(Vet/FRU) 1 For vet 115-065682-00 2116 PC Keyboard(Vet/FRU/ Russian) 1 For vet, Russian B4 051-001383-01 TGC Board 1 Not include the connecting cable B5 043-003277-00 TGC CAP(M9) 8 B2 B3 7-6 Field Replaceable Unit 7.2.3 Main Unit Assembly (C0) C3 C2 C6 C1 C9 C14 C13 C5 C10 C4 C11 C12 C7 C8 C13-1 Field Replaceable Unit 7-7 No. Order Number Part Name Qty. 115-023067-00 M9 Main Board(FRU) 1 115-048332-01 C1 115-033406-00 115-048333-01 115-055539-01 M9 Main Board(eDP+M.2/8s/FRU) 1 Main Board(M9GI/FRU) 1 Includes button battery and radiator washer. Only used for repair of old M9 (SN starts with 7B,7C,7D,CAW) Remark software version, machine model, human use or veterinary and sale region. Includes button battery and radiator washer. Only used for repair of new M9 (SN starts with CC1,CC2,CC3,CC5) Remark software version. Only used for repair of old M9GI (SN starts 8K) Remark software version. 1 Only used for repair of new M9GI (SN starts with CC4) M8 Main Board(M8 Series/8s/FRU) 1 Remark software version, machine model 1 LVDS signal, for repair of the old M9 (SN starts with 7B, 7C,7D,8K, CAW); The MAC address will change with the replacement of CPU, so you may need apply the optional key the machine installed before. CPU Module(6100 PC module/eDP output/FRU) 1 eDP signal, for repair of new M9(SN starts with CC1,CC2,CC3,CC4,CC5) only; The MAC address will change with the replacement of CPU, so you may need apply the optional key the machine installed before. CPU Module(FRU) 115-048330-01 C3 115-050982-00 TR64 Board(2116/FRU) 1 C4 115-035832-00 ECG Assembly(FRU) 1 7-8 Field Replaceable Unit Remark software version, machine model, human use or veterinary and sale region. M9 Main Board(M9GI/eDP+M.2/8s/FRU) 115-023066-00 C2 Remark No. Order Number Part Name Qty. Remark C5 115-023070-00 Probe Board Assembly(FRU) 1 C6 115-023068-01 PHV Power Board(FRU) 1 C7 115-023405-00 M9 Li-ion battery FRU 1 Including two batteries, should be replaced together SSD Card(M9/CE/FRU/Win 7) 1 For old M9(SN starts with 7B) only; Mark Software version when order it. 115-024561-00 115-024562-00 115-024563-00 115-045290-00 115-033405-00 C8 115-024561-01 115-024562-01 115-024563-01 115-045290-01 115-033405-01 115-055535-00 SSD Card(M9CV/CE/FRU/Win 7) SSD Card(M9T/CE/FRU/Win 7) SSD Card(M9Vet/CE/FRU/Win 7) SSD Card(M9GI/CE/FRU/Win 7) SSD Card(M9/CE/FRU/6100 PC/Win 7) SSD Card(M9CV/CE/FRU/6100 PC/Win 7) SSD Card(M9T/CE/FRU/6100 PC/Win 7) SSD Card(M9Vet/CE/FRU/6100 PC/Win 7) SSD Card(M9GI/CE/FRU/6100 PC/Win 7) SSD Card(M8/CE/FRU/6100PC/Win 7) 1 For old M9CV(SN starts with 7C) only; Mark Software version when order it. 1 For old M9T(SN starts with 7D) only; Mark Software version when order it. 1 For old M9Vet(SN starts with CAW) only, Mark Software version when order it. 1 For old M9GI(SN starts with 8K) only; Mark Software version when order it. 1 For new M9(SN starts with CC1) only; Mark Software version when order it. 1 For new M9CV(SN starts with CC2) only; Mark Software version when order it. 1 For new M9T(SN starts with CC3) only; Mark Software version when order it. 1 For new M9Vet(SN starts with CC5) only; Mark Software version when order it. 1 For new M9GI(SN starts with CC4) only; Mark Software version when order it. 1 For M8 only; Mark Software version when order it. Field Replaceable Unit 7-9 No. Order Number Part Name 115-055536-00 SSD Card(M8CV/CE/FRU/6100PC/Win 7) 115-055537-00 SSD Card(M8T/ CE/FRU/6100PC/Win 7) 115-055538-00 SSD Card(M8GI/ CE/FRU/6100PC/Win 7) 115-026787-02 SSD Card(M9/FDA/FRU/Win10) 115-026788-02 SSD Card(M9CV/FDA/FRU/Win10) 115-026789-02 SSD Card(M9T/FDA/FRU/Win10) 115-033405-02 SSD Card(M9GI/CE/FRU/Win10) 115-024563-02 SSD Card(M9T/CE/FRU/Win10) 115-024562-02 SSD Card(M9CV/CE/FRU/Win10) 115-024561-02 SSD Card(M9/CE/FRU/Win10) 115-055538-01 SSD Card(M8GI/CE/FRU/Win10) 115-055537-01 SSD Card(M8T/CE/FRU/Win10) 115-055536-01 SSD Card(M8CV/CE/FRU/Win10) 115-055535-01 SSD Card(M8/CE/FRU/Win10) 7-10 Field Replaceable Unit Qty. Remark 1 For M8CV only; Mark Software version when order it. 1 For M8T only; Mark Software version when order it. 1 For M8GI only; Mark Software version when order it. 1 For new M9(SN starts with CC1) only; Mark Software version when order it. 1 For new M9CV(SN starts with CC2) only; Mark Software version when order it. 1 For new M9T(SN starts with CC3) only; Mark Software version when order it. 1 For new M9GI(SN starts with CC4) only; Mark Software version when order it. 1 For new M9T(SN starts with CC3) only; Mark Software version when order it. 1 For new M9CV(SN starts with CC2) only; Mark Software version when order it. 1 For new M9(SN starts with CC1) only; Mark Software version when order it. 1 For M8GI only; Mark Software version when order it. 1 For M8T only; Mark Software version when order it. 1 For M8CV only; Mark Software version when order it. 1 For M8 only; Mark Software version when order No. Order Number Part Name Qty. Remark it. 115-048923-01 023-001226-00 C9 023-001528-00 SSD Card(M8Elite/FDA/FRU/Win10) Wireless net adapter Wi-Fi module Wi-Fi + BT 1 For M8Elite only; Mark Software version when order it. 1 miniPCIE interface, for repair of old M9 ((SN starts with 7B,7C,7D,8K) only 1 M.2 interface, for repair of new M9(SN starts with CC1,CC2,CC3, CC4) and all M8 series 2 in 1 C10 020-000034-00 Speaker and cable 1 C11 043-003265-00 Front dust-proof mesh of main unit 2 C12 043-003268-00 Edge dust-proof mesh of main unit 1 C13 115-017214-00 Bottom cover assembly of main unit 1 C13-1 049-000561-00 Rubber foot 6 4 on bottom cover and 2 on battery cover C14 115-023074-00 M9 Fan(FRU) 1 6 in 1 Field Replaceable Unit 7-11 7.2.4 Cables (D0) No. Order Number Part Name Qty. D1 009-003292-00 Trackball signal cable 1 D2 009-003293-00 Control panel signal cable 1 D3 2108-20-65853 STC connecting cable 1 009-005417-00 Brazil power cord (3.5m) 1 009-003701-00 Adapter power cord( U.K,2.5M) 1 009-003703-00 Adapter power cord( Europe,2.5M) 1 D4 7-12 Field Replaceable Unit Remark 7.2.5 Accessories (E0) No. Order Number Part Name Qty. E1 022-000147-00 Adapter 100-240VAC 19V 150W 1 E2 115-020783-01 iDock51 Audio/Video Extension Module 1 E3 115-020784-00 PEM-51 Probe Extension Module 1 E4 115-022425-00 DVD-RW Kit 1 115-052996-00 Bar Code Scanners 1 115-052997-00 Bar Code Scanners(support RFID) 1 115-053023-00 Bar Code Scanners(Turkey) 1 115-053024-00 Bar Code Scanners(support RFID,Turkey) 1 115-028357-01 USB to network converter 1 115-024047-00 MIC head ECG Lead(CE) E5 E6 1 E7 Remark Includes: 1. ECG cables; 2. DC-IN cable (support MIC port). 1 Includes: 1. ECG cables; 2. DC-IN cables (support BNC port and iMEC port). 115-030429-00 BNC head ECG Lead(CE) E8 040-000072-00 ECG Cable - neonatal 1 E9 115-056309-00 McAfee Kit 1 E10 048-004129-00 M9 Ordinary Probe Bag 1 E11 048-004130-00 M9 Intracavity Probe Bag 1 Field Replaceable Unit 7-13 No. Order Number Part Name Qty. E12 115-039785-00 M9 Luggage(FRU) 1 E13 049-001025-00 M9 keyboard shelter 1 7-14 Field Replaceable Unit Remark 7.2.6 UMT-500 Mobile Trolley (F0) F14 F8 F6 F13 F1 F9 F11 F12 F5 F2 F3 F4 F17 F10 No. Order Number Part Name Qty. F1 115-021103-00 USB-HUB assembly 1 F2 051-001386-02 Cart AC Connector Board 1 F3 051-001387-02 Cart Battery Control Board 1 F4 022-000148-00 Power Supply Board 1 Remark Field Replaceable Unit 7-15 No. Order Number Part Name Qty. Remark F5 024-000320-00 FAN 1 F6 115-037617-01 probe holder&cup bracket(FRU) 2 Can be installed on both left and right side of the trolley Can be installed on trolley with EFP018F or above version only; can be installed on both left and right side of trolley; for both upgrade and maintenance. F7 115-045239-00 Inner chamber probe holder Assy(FRU) 1 F8 801-2102-00016-00 transducer cable hook 1 F9 045-002938-00 F10 115-015314-00 Castor(FRU) 4 F11 034-000353-00 Drawer lock 1 F12 043-003430-00 M9 Cart front bin 1 F13 043-003592-00 2116 cart back pallet 1 F14 115-020346-00 Trolley panel cover assembly 1 F15 009-003334-00 power cable for M9 1 The retractable power cable in the trolley F16 009-003330-00 USB signal cable 1 The USB signal cable in the trolley F17 115-058717-00 lithium-ion Battery FRU(CFDA/CE) 1 Only for maintenance, includes 2pcs 7-16 Field Replaceable Unit Hook Bracket 1 Can be used on the trolley with EFP018F or above version. 8 Structure and 8.1 Structure of the Complete System 8.1.1 Main Unit Assembly/Disassembly Fig Overall Exploded View No. Name No. Name 1 Display (monitor) assembly 5 Hardware cover 2 Control panel assembly 6 Battery 3 Machine board assembly 7 Battery cover assembly 4 Back cover assembly of main unit Structure and Assembly/Disassembly 8-1 8.1.2 Mobile Trolley No. Name No. Name 1 Trolley panel cover assembly 5 Probe cable hook assembly 2 Cast-aluminum base assembly of trolley panel 6 Storage tray 3 Power supply assembly 7 Probe extender assembly 4 Trolley base assembly 8 Lifting column assembly 8-2 Structure and Assembly/Disassembly 8.2 Main Unit Assembly/Disassembly This section describes the disassembling and assembling of the main parts and hardware boards. The assembling is the inverse process of disassembling if not mentioned in particular. Sketch Note: The illustration of disassembly is for reference only; please relies on the actual model. 8.2.1 Preparation 8.2.1.1 Disassembly Tools Required Name Type Material No. Remarks Cross-headed screwdriver 107*75 / M2 Cross-headed screwdriver 102*100 0000-10-10884 M3、M4 Spanner 1PK-H024 095-000063-00 4″ Diagonal cutting pliers N-206S 095-000077-00 / / / / Anti-electrostatic glove: 1 pair. 8.2.1.2 Engineers Required The disassembly should be performed by professionals from Mindray or the staff who are qualified for the maintenance after the training. Structure and Assembly/Disassembly 8-3 8.2.1.3 Disassembly Requirements Be prepared before disassembling ultrasound device. 1. Stop scanning the patient and capturing images. Shut down the device and cut off AC power supply. Unplug AC power supply cable. 2. Be prepared for a softer platform and keep the platform clear. Prevent the device from scrape. 3. Get the tools and gloves prepared. 8.2.2 Battery Note: it is recommended to remove the battery first, and the remove other parts when the power supply is cut off. 1. Unscrew 3 screws on the battery cover (2 M3 X 20 cross head screws, 1 M3 X 8 Nylok screw). Remove the battery cover towards the direction as blue shows. Battery cover M3X8 Nylok screw M3X20 panhead screw (2 screws) 2. Pull the white tab up. Take out the battery. 8-4 Structure and Assembly/Disassembly Battery 8.2.3 1. Tab Dust-proof Mesh of Main Unit Take out the dust-proof mesh on the right side. Dust-proof mesh on the right side 2. Take out the dust-proof mesh in front of main unit. Dust-proof mesh in front of main unit Structure and Assembly/Disassembly 8-5 8.2.4 1. Network Adaptor Unscrew four screws (M3 X 6 cross panhead screw) on the hard disk cover, and then remove the hard disk cover. Hard disk cover 2. M3 X 6 cross panhead screw (4 screws) Extract the network cables. Extract the signal cables of monitor via black handle. Network adaptor snap closure Extract signal cables of monitor via black handle 3. Push the metal snap closure backwards as the thick arrow shows. Take the wireless network adaptor out by following the direction as left thick arrow shows. 8-6 Structure and Assembly/Disassembly Two metal snap closure to lock wireless network adaptor Metal snap closure Wireless network adaptor 4. Remove button battery Hold the button battery gently. Put the sharp end of the tweezers or flat-headed screw into the gap between battery and bulges of plastic cover. The button battery bounces off then. Note: do not press hard in the operation. Bulges of plastic cover 8.2.5 SSD Card 1. Remove the hard disk cover. See the first step in Chapter 8.2.4. 2. Push the metal clasp towards the blue arrow’s direction. Structure and Assembly/Disassembly 8-7 Metal clasp 3. Take out SSD card. 8.2.6 Control Panel and Monitor 1. Remove network adaptor and battery assembly. See Chapter 9.2.2 and Chapter 9.2.3 for details. 2. Unscrew 11 screws on the back cover (M3 X 8 Nylok screw). 8-8 Structure and Assembly/Disassembly M3X8 Nylok screw (11 screws) 3. Open control panel. Extract the signal cables of control panel, and remove the control panel. Extract signal cables of control panel 4. Unscrew 4 screws (M3 X 8 Nylok screws) as shown in the Figure. Remove the monitor upwards. Structure and Assembly/Disassembly 8-9 M3X8 Nylok screw (2 screws for each left and right side) 8.2.7 Remove the monitor assembly upwards ECG Assembly 1. Remove control panel and monitor assembly. See Chapter 9.2.4 for details. 2. Unscrew 4 screws on CG shield cover (M2 X 4 stainless steel cross head screws). Remove the shield cover. M2 X 4 stainless steel cross head screw (4 screws) 3. Remove the ECG cable pressure plate, and remove 4 screws on ECG board ((M2 X 4 stainless steel cross head screws). Remove ECG board. Extract ECG signal cables. 8-10 Structure and Assembly/Disassembly M2 X 4 stainless steel cross head screw (4 screws) Pressure plate ECG signal cables 4. Unscrew 2 screws on ECG fixing bracket (M3 X 8 Nylok screw).Remove ECG's fixing bracket and extract ECG connecting cables. M3 X 8 Nylok screw (2 screws) ECG fixing bracket 5. ECG connecting board Connecting cables to ECG socket Remove the speaker assembly. Unplug the socket on the main board. Structure and Assembly/Disassembly 8-11 Socket to speaker 8.2.8 Speaker assembly Fan 1. Remove control panel and monitor assembly. See Chapter 9.2.4. 2. Unplug the connecting cable of fan. Remove the hot-melt adhesive. Take out the fan. Fan plug 3. Hot-melt adhesive Fan's shield cover Remove the fan’s shield cover. 8.2.9 Probe Board Assembly 1. Remove control panel and monitor assembly. See Chapter 9.2.4 for details. 2. Unscrew 2 screws (M2 X 4 stainless steel cross head screw). Take out the connecting socket of probe board. 8-12 Structure and Assembly/Disassembly M2 X 4 stainless steel cross head screw (2 screws) 3. Unscrew 3 screws on the fixing bracket of probe socket (M3 X 8 Nylok screw). M3 X 8 Nylok screw (3 screws) 4. Take out the probe board assembly. 5. Unscrew 4 screws on probe’s socket (M3 X 8 Nylok screw). Take out the probe’s socket. Structure and Assembly/Disassembly 8-13 M3 X 8 Nylok screw (4 screws) 6. Probe socket Probe board Disassemble IO fixing bracket, fixing bracket of pencil probe structure. Unscrew 2 screws on IO fixing bracket (M3 X 8 Nylok screw). Take out IO fixing bracket. IO fixing bracket M3 X 8 Nylok screw (2 screws) Unscrew 2 screws on the fixing bracket of pencil probe (M3 X 8 Nylok screw). M3 X 8 Nylok screw (2 screws) Fixing bracket of pencil probe 8.2.10 Machine Board Assembly 1. Remove control panel and monitor assembly. See Chapter 9.2.4 for details. 8-14 Structure and Assembly/Disassembly 2. Disassemble machine board assembly. Unscrew 11 screws (M3 X 6 cross panhead screw). Take out the machine board assembly. Machine board assembly 3. M3X6 cross panhead screw (11 screws) Disassemble TR64 board Unscrew 7 screws on TR64 board (M3 X 6 cross panhead screws). Take out TR64 board with forces. M3 X 6 cross panhead screw (7 screws) TR64 board Structure and Assembly/Disassembly 8-15 4. Disassemble PHV power supply board Unscrew one screw on grounding elastic sheet (M2.5 X 12 cross panhead screw) M2.5 X 12 cross panhead screw (1 screw) Grounding elastic sheet Unscrew 4 screws on larger shield cover of PHV board (M3 X 6 cross panhead screw). Remove the larger shield cover of PHV board. M3 X 6 cross panhead screw (4 screws) Larger shield cover of PHV board Unscrew 1 screw on smaller shield cover of PHV board (M3 X 6 cross panhead screw). Remove the smaller shield cover of PHV board and PHV board. 8-16 Structure and Assembly/Disassembly M3 X 6 cross panhead screw (1 screws) 5. Smaller shield cover of PHV board Disassemble CPU assembly. Unscrew four screws (M2.5 X 12 cross slot bolt) on CPU assembly, and then remove the CPU assembly. M2.5X12 cross slot bolt (4 screws) NOTE Do not open the BIOS base shown in the following figure when disassembling the CPU board assembly. Ensure the BIOS base is closed before re-assembling the CPU board assembly. Press it until closed if it is opened. Otherwise, it fails to boot the device up. Structure and Assembly/Disassembly 8-17 8.2.11 Control Panel Assembly 1. Remove control panel. See step 1 to step 3 in Chapter 9.2.4 for details. 2. Remove standard small keyboard a) Unscrew 4 screws on water-proof plate (M3 X 6 cross panhead screw). Remove the water-proof plate. Push the socket clasp towards the blue arrow, and then take out flexible PCB. M3 X 6 cross slot screw (4 screws) b) Flexible PCB Remove the water-proof plate of standard small. Water-proof plate of standard small c) Unscrew 6 screws locking the standard keyboard. Take out the small keyboard upwards. 8-18 Structure and Assembly/Disassembly M3X6 cross slot screw (6 screws) 3. Remove the caps on the control panel. Pull out the cap upwards. Caps for: small encoder button (Zoom), TCG cap (8 caps), large encoder button (Auto Correct), large encode button (iTouch). Large encoder button (Auto Correct) Large encoder button (iTouch) Small encoder button (Zoom) TGC cap (8 caps) 4. Disassemble the buzzer. Structure and Assembly/Disassembly 8-19 Unscrew 2 screws locking the buzzer (M2 X 6 cross panhead screw). Unplug the connecting cables of the buzzer from PCB board, and remove the buzzer. M2 X 6 cross panhead screw with pad (2 screws) Connecting cable of buzzer 5. Disassemble the trackball. Unscrew two screws as shown in the following figure (M3 X 20 cross panhead screw). Unplug the connecting cable of the trackball, and take out the trackball. Connecting cable of trackball 8-20 Structure and Assembly/Disassembly M3 X 20 cross panhead screw (2 screws) 6. Disassemble TGC board Unscrew 4 screws on TGC board (M3 X 6 stainless steel cross panhead screw). Unplug STC connecting cables. Remove TCG board. M3 X 6 stainless steel cross panhead screw (4 screws) STC connecting cable 7. Disassemble the control panel PCBA Unscrew 20 screws (M3 X 6 stainless steel cross panhead screw) on control panel PCBA. Remove control panel PCBA. M3 X 6 stainless steel cross panhead screw (20 screws) Structure and Assembly/Disassembly 8-21 8. Disassemble caps Remove button caps on the control panel. Disassemble button caps 9. Disassemble magnetic induction chip and status indicator. Unscrew 4 screws (M3 X 6 cross panhead screw, 2 screws for each left and right side) from magnetic induction clip. Take out the magnetic chip. Unscrew 2 screws (M3 X 6 cross panhead screw, 1 screw for each left and right side) from status indicator. Take out the status indicator. M3 X 6 cross panhead screw (4 screws, 2 screws for each left and right side) Magnetic induction chip Status indicator M3 X 6 cross panhead screw (2 screws, one screw for each left and right side) 10. Disassemble silicon keyboard Silicon keyboard is installed on the control panel PCBA via interference fit of silicon bearings (back of PCBA). Remove the silicon keyboard from control panel. 8-22 Structure and Assembly/Disassembly Silicon keyboard Control panel PCBA Silicon bearing (24 bearings) 11. TGC dust-proof cover TGC dust-proof cover is installed on TGC board via interference fit of silicon bearings. Remove TGC dust-proof from TGC board. TGC dust-proof cover TGC board Silicon bearing (4 bearings) 8.2.12 Display (monitor) Assembly 1. Remove the monitor assembly. See Chapter 9.2.4 for details. 2. Disassemble front cover of the monitor. Take out 4 screw caps from 4 corners of the monitor. Unscrew four screws inside. Note: keep screw caps properly. Structure and Assembly/Disassembly 8-23 Screw cap. Unscrew M2.5 X 4 cross panhead screw (4 screws) Take out the front cover along the left side (or right side), and then take out it along the frame of the monitor. Take out the front cover form both sides 3. Unscrew 1 screw on the cable harness (M2.5 X 5 cross slot screw), and remove the cable harness. Take out the cables from channel. M2.5 X 5 cross slot screw (1 screw) Cable harness 8-24 Structure and Assembly/Disassembly 4. Disassemble WIFI cables WIFI cables stick to the back cover of the monitor. Tear the WIFI cables and aluminum foil off. WIFI cables and aluminum foil 5. Disassemble light sensor board Unscrew 2 screws on light sensor board (M2.5 X 4 cross panhead screw). Take out the light sensor board. M2.5 X 4 cross panhead screw (2 screws) Light sensor board 6. Disassemble LCD Monitor Unscrew 6 screws from LCD monitor’s six corners (M2 X 4 cross panhead screw), and remove LCD monitor. Structure and Assembly/Disassembly 8-25 M2 X 4 cross panhead screw (2 screws) 7. Disassemble left/right damping axis Unscrew 6 screws on damping axes from left and right sides (M2.5 X 5 cross slot screw, 3 screws for each left and right side), and remove damping axis. M2.5 X 5 cross slot screw (6 screws, 3 screws for each left and right side 8. Disassemble the magnetic snap closure of the monitor. Unscrew four screws on the magnetic snap closure (M2.5 X 4 cross panhead screw, 2 screws for each left and right side), and remove the metal part and the magnet. 8-26 Structure and Assembly/Disassembly M2.5X4 cross panhead screw, 4 screws; 2 screws for each left and right side Fixing metal part to magnet 8.3 Trolley Assembly/Disassembly 8.3.1 Preparation 8.3.1.1 Disassembly Tools Required Name Material No. Remarks Cross-headed screwdriver 107*75 / M2 Cross-headed screwdriver 102*100 0000-10-10884 M3、M4 Inner hexagon spanner 369H(1.5-6.0mm) 095-000062-00 M5 1PK-H024 095-000063-00 4″ Diagonal cutting pliers N-206S 095-000077-00 / Anti-electrostatic glove: 1 pair. / / / Spanner 8.3.1.2 Type Magnet Engineers Required The disassembly should be performed by professionals from Mindray or the staff who are trained to be qualified for the maintenance. Structure and Assembly/Disassembly 8-27 8.3.1.3 Disassembly Requirements Be prepared before disassembling ultrasound device. 1. Stop scanning the patient and capturing images. Shut down the device and cut off AC power supply. Unplug AC power supply cable. 2. Lock the casters to prevent the device from moving in the disassembly. 3. Get the disassembly tools prepared. 8.3.2 1. Storage Box Remove the storage box upwards. Storage box 2. Unscrew 2 screws on bracket of storage box (M4 X 12 cross panhead screw), and remove the bracket of the storage box. 8-28 Structure and Assembly/Disassembly M4X12 cross panhead screw (2 screws) 8.3.3 1. Power Supply Assembly Unscrew two M4X10 stainless steel round inner head screws (with the pad) on the front of the main unit, and then disassemble two M4X10 stainless steel round inner head screws (with the pad) on the back of the main unit. Pull out the power supply assemble by the metal handle. Two M4X10 stainless steel round inner head screws (with the pad) 2. Bracket of storage box Two M4X10 stainless steel round inner head screws (with the pad) Metal handle of power supply assembly Remove dust-proof mesh Press the clip outwards (arrow 1). Pull out the plastic clasp towards the arrow 2’s direction. Structure and Assembly/Disassembly 8-29 Clip 1 2 The plastic clasp 3. Remove the battery Unscrew 3 screws (M4 X 12 cross panhead screw) on the battery baffle board. Remove the battery baffle battery, and then take out the battery. M4X12corss panhead screw (3 screws) 4. Battery Remove the battery compartment and battery management board Unscrew 6 screws (M4 X 12 cross panhead screw, 3 screws for each left and right side) on the battery compartment, and then take out the battery compartment. 8-30 Structure and Assembly/Disassembly M4X12cross panhead screw (6 screws, 3 screws for each left and right side) Unscrew 6 screws (M3 X 8 cross panhead screw) on the battery management board, and then remove the battery management board. M3X8 cross panhead screw (6 screws) 5. Remove AC-DC power supply assembly Unscrew 4 screws (M4 X 8 cross panhead screw) on AC-DC supporting board, and take out AC-DC assembly. Structure and Assembly/Disassembly 8-31 M4X8 cross panhead screw (4 screws) Unscrew 4 screws (M4 X 8 cross panhead screw) on the back of AC-DC supporting board, and take out AC-DC power supply board. M3X6 cross panhead screw (4 screws) 6. Unscrew 4 screws on the power supply fan (M4 X16 cross panhead with the pad and the clip). Take out the fan. 8-32 Structure and Assembly/Disassembly M4X16 cross panhead with the pad and the clip (4 screws) 8.3.4 1. Trolley Panel Board Assembly Unscrew 10 screws (M4 X 12 cross panhead screw) on the back of trolley panel’s base, and take out the panel cover. M4X12 cross panhead screw (10 screws) 2. Remove the rotatable clasp Unscrew 2 screws on the fixing bracket for the spring (M4 X 12 cross panhead screws), and take out the fixing bracket and the spring. Structure and Assembly/Disassembly 8-33 Fixing bracket for the spring M4X12 cross panhead screw (2 screws) Unscrew 2 screws (M4 X 12 cross panhead screw) on the fixing base of the pivot, and remove the fixing base of the pivot, then take out the rotatable clasp. M4X12 cross panhead screw (2 screws) 8.3.5 Fixing base of the pivot Rotatable clasp Spring Assembly 1. Remove the assembly of trolley panel cover. See Chapter 9.3.2.3 for details. 2. Remove LED board, USB board, fixing bracket of power supply cable, etc. Unscrew 2 screws (M3 X 8 cross panhead screw) on LED board, and take out LED board. Unscrew 4 screws (M3 X 8 cross panhead screw) on USB board, and take out USB board. Unscrew 1 screw (M4 X 12 cross panhead screw) on wiring fixation, and then take out the wiring fixation. Unscrew 2 screws on the fixing bracket that outlet line passes through (M4 X 12 cross panhead screw), and remove the bracket. 8-34 Structure and Assembly/Disassembly M3X8 cross panhead screw (2 screws) 3. M3X8 cross panhead screw (4 screws) M4X12 cross panhead screw (1 screw) M4X12 cross panhead screw (2 screws) Remove the drawer lock. a) Unscrew the screws on the drawer lock. Remove the connecting plate between the screw and the key lock. Connecting plate of key lock b) Screw on the drawer lock Take out the drawer lock by unscrewing hexagon screw. Structure and Assembly/Disassembly 8-35 Hexagon screw 4. Drawer lock Remove spring cable a) Remove the fixing bracket of spring cable Unscrew 2 screws (M4 X 12 cross panhead screw) on the base, and take out the bracket of spring cable. M4X12 cross panhead Trolley base screw (2 screws) b) The socket of spring cable Fixing bracket of spring cable Remove spring cable Press gas spring button. Press the device to the lowest by the handle. Gas spring Handle 8-36 Structure and Assembly/Disassembly Unscrew 2 screws (M4 X 12 cross panhead screw) on the injection-molding clasp of spring cable on the base. M4X12 cross panhead screw (2 screws) Unscrew 2 screws (M4 X 12 cross panhead screw) on the base of control panel, and take out the panel cover. M4X12 cross panhead screw (2 screws) 5. Take out the spring cable upwards Remove the connecting rod of gas spring. Press gas spring button (the sixth step), remove the handle upwards. Release the spring to the maximum length (operable to remove gas spring assembly). Put the auxiliary tool (M5 screw or screw driver) into the spacing hole on the back of the device (operable to remove trolley panel board). Structure and Assembly/Disassembly 8-37 Put auxiliary tool (M5 screws or screw driver) into spacing hole Unscrew 2 screws (M4 X 12 cross panhead screw) on the connecting rod of gas spring. M4X12 cross panhead screw (2 screws) Lift up the connecting rod of gas spring, and take out the spring of the connecting rod, then remove the connecting rod towards arrow’s direction. 8-38 Structure and Assembly/Disassembly Remove the connecting rod towards arrow’s direction Spring of the connecting rod 6. Remove gas spring Unscrew 6 screws (M5 X 25 Allen screw with the pad and the clip) on the connecting base of the gas spring. M5X25 Allen screw with the pad or the clip (6 screws) Connecting base Remove the latch of the gas spring at the bottom of the lifting column. Take out the gas spring upwards. Structure and Assembly/Disassembly 8-39 Latch of gas spring 8.3.6 Trolley base Gas spring Cast-aluminum Base of Trolley Panel 1. Remove the assembly of trolley panel cover and spring assembly. See Chapter 9.3.2.3 and Chapter 9.3.2.4 for details. 2. Unscrew 8 screws (M5 X 25 Allen screw with the pad and the clip) on the cast-aluminum base, and remove the panel’ base upwards. M5X25 inner head screw with the pad and the clip (8 screws) 3. Cast-aluminum base of trolley panel Remove the printer tray Unscrew 4 screws (M4 X 12 cross panhead screw) on the printer tray, and take out the printer tray. 8-40 Structure and Assembly/Disassembly M4X12cross panhead screw (4 screws; 2 screws for each left and right side) 4. Remove holder bracket, hook base of probe cable, moveable cable hook. Unscrew 6 screws (M4 X 12 cross panhead screw, 3 screws for each left and right side) on the holder bracket, and then take out the holder bracket. Unscrew 2 screws (M4 X 12 cross panhead screw) on the base of probe holder, and take out the base of probe holder. Unscrew 2 screws (M4 X 12 cross panhead screw, 1 screw for each left and right side) on the cable hook, and then take out the cable hook. Base of probe holder M4X12 cross panhead screw (10 screws) Holder bracket (one for each left and right side) Cable hook (one for each left and right side) Structure and Assembly/Disassembly 8-41 8.3.7 Lifting Column 1. Remove cast-aluminum base of trolley panel. See Chapter 9.3.2.5 for details. 2. Lay the device flat. Remove 8 screws (M5 X 25 Allen screw with the pad and the clip) on the base. Take out the lifting column towards arrow’s direction. M5X25 Allen screw with the pad and the clip (8 screws) 3. Take out the lifting column towards arrow’s direction Remove external lifting column Pull the lifting column to the maximum position towards arrow’s direction. Unscrew 8 screws (M6 X 16 Allen screw with the pad and the clip) on the external lifting column. Take out the external lifting column. Note: there is a piece of strip on the screw. Remove the strip before unfastening the screws. M6X16 Allen screw with the pad and the clip (8 screws) 4. External lifting column Remove the straight track. Unscrew 8 screws (M5 X 12 Allen screw with the pad and the clip) on internal lifting column, and take out the straight track. 8-42 Structure and Assembly/Disassembly Straight track 8.3.8 M5X12 Allen screw with the pad and the clip (8 screws) Trolley Base Assembly 1. Remove the lifting column. See Chapter 6.3.7 for details. 2. Remove the clip of gas spring. Unscrew 3 screws (M5 X 25 Allen screw with the pad and the clip) on the connecting base of gas spring. Remove the connecting base of the gas spring. Unscrew 2 screws (M3 X 8 cross panhead screw) on the clip, and then take out the clip. M5X25 Allen screw with the pad and the clip (3 screws) 3. M3X8 cross panhead screw (2 screws) Remove the casters Unscrew the hexagon screw between the casters and the base with dedicated jig. Structure and Assembly/Disassembly 8-43 Cast-aluminum base 4. Unscrew the screws Caster Remove metal strips Unscrew 14 screws (M4 X 12 cross panhead screw) at the bottom of cast-aluminum base. Remove the front pegboard, back pegboard and the strip of power supply box (one piece for each left and right side). Front pegboard 5. M4X12 cross panhead screw (14 screws) Strip of power supply box (one piece for each left and right side) Back pegboard Remove the decorative cover of the base. Unscrew 4 screws (M3 X 8 cross panhead screw) on cast-aluminum base. Remove the decorative cover upwards. 8-44 Structure and Assembly/Disassembly M3X8 cross panhead screw (4 screws) 8.3.9 Remove the decorative cover towards arrow’s direction Installation of probe holder 1. Two hooks of probe holder are inserted into holder bracket diagonally. 2. Press the probe holder inward as well as downward at the same time. Structure and Assembly/Disassembly 8-45 3. Stuff two screws behind the holder bracket (cross panhead screw M3X6) Fasten two cross panhead screws M3X6 8-46 Structure and Assembly/Disassembly 8.3.10 Disassembly of the probe holder Disassemble the probe holder and three screws (M4X12 Philips pan headed screws) connected with the base of control panel, then remove the probe holder and holder bracket as a whole. NOTE: Don’t remove those two screws (cross panhead screw M3X6) of probe holder and holder bracket. Unscrew M4X12 Philips Pan headed screws (3pcs) 8.3.11 Disassembly of intracavity probe holder 1. Disassemble intracavity probe holder Pull out the intracavity probe holder as the arrow’s direction. Structure and Assembly/Disassembly 8-47 Intracavity probe holder 2. Disassemble intracavity probe holder bracket Unscrew two screws (cross panhead screw M3X12) Intracavity probe holder bracket cross panhead screw M3X12(2pcs) 3. Disassemble padding block Unscrew two screws (cross panhead screw M3X12) 8-48 Structure and Assembly/Disassembly Padding block Cross panhead screw M3X12(2pcs) Structure and Assembly/Disassembly 8-49 9 Installation of Option 9.1 Installation of Optional Devices to Software Modules Install 1. Copy optional key file to USB flash disk and plug USB flash disk to the port. 2. Open [Setup] menu. Click [Maintenance]-[Option]. Select the software package to be installed from the list. 3. Click [Install]. Select key file from the dialog box, and then click [OK]. 4. The optional assembly becomes “Installed” after the key file is installed. The corresponding function is activated after return from preset. 5. Option trial: select the corresponding software package, and then lick [Trial]. Note: for each component, you can activate trial version only once. The trial lasts 180 days for each key. Installation of Option Modules 9-1 Note: 1. The optional assembly is limited to single key. If the module is installed or there are 2 or more than 2 groups of the modules are selected, the installation button appears dimmed and disabled. 2. After all modules are installed, please go to the previous interface to confirm. Promote 1. Click [Promote]. The following image appears: Note: the promotion function is only applied to the uninstalled key. If the optional key is installed, the promotion function is disabled. 2. 3. Select the key to be promoted. Click [OK] to complete the promotion. 9-2 Installation of Option Modules Note: it is unavailable to use promotion for multiple optional keys. For the optional key which is promoted, it can also be installed. The installation to promotion key is same with these in Chapter 9.1 Install above. Uninstall 1. Select the software package to be uninstalled from option list. 2. Click [Uninstall] and it pops up the [Confirm] dialogue box. Click [OK]; 3. Return to the system preset interface. The optional devices status changes into "installed". Note: 9.2 The removal function is exclusive to internal users. The service engineers must log in the system with the account of “Service”, and then perform the installation. Installation of the Accessory Kits and Optional Devices to Hardware Hardware configuration list the system supports is displayed as shown below: No. Material No. Descriptions 1 115-020354-01 Audio/Video extend module 2 115-023076-00 Probe extend module Material and pictures Installation Reference / 9.2.3 9.2.2 Installation of Option Modules 9-3 9.2.1 Storage Tray Remove the storage tray downwards. Take out the tray. Remove the storage tray downwards. Take out the tray 9.2.2 1. Probe Extender Assembly Unscrew 4 screws (M4 X 12 cross panhead screw) on the pegboard of probe extender assembly. M4X12 cross panhead screw (4 screws) Pegboard Figure 9-1 2. Install the probe extender assembly towards arrow’s direction. 9-4 Installation of Option Modules Install the assembly towards arrow’s direction Figure 9-2 3. Screw 2 screws (M4 X 12 cross panhead screw) on the back of probe extender assembly. M4 X 12 cross panhead screw (2 screws; one screw for each left and right side) Figure 9-3 9.2.3 Audio/Video Extender Assembly Push the metal clip on the left side to the bottom. Take put the audio/video extender assembly rightwards. Installation of Option Modules 9-5 Metal clip 9.2.4 Audio/video extender assembly Trolley Installation The service staff installs the trolley according to the following steps after receiving the package: 1. Open the package. See Chapter 3.2.1.1 for details. 2. Install the holders on right and left sides. As shown in the following figure a) and b), place the probe holder into the holes of the left and right plate of the trolley. The probe holders that are installed are shown in figure c. 9-6 Installation of Option Modules Holder on left side Holder on right side b) a) c) Figure 9-4 Installation for holders on right and left sides 3. Install cable hook As shown in figure 1, aim the installation axis’s rabbet of probe hook assembly at the screw of fixing base, and then insert the probe hook assembly to the fixing base. Rotate the assembly anticlockwise to fix it (see figure b).The probe holders that are installed are shown in figure c. Installation of Option Modules 9-7 Rotate probe hook assembly anticlockwise Probe hook assembly Screw a) Fixing base b) d) Figure 9-5 -Installing probe hook assemblyInstall storage tray. Install the option modules if there are relevant modules for options: probe extend module, audio/video extend module. See Chapter 9.2.2 and Chapter 9.2.3 for details. 9-8 Installation of Option Modules 10 System Diagnosis and Support 10.1 General Status Indicator 10.1.1 Indicators of Control Panel Status indicators Power-on indicator status Icon Status definition and indicators Off: System turned off; When pressing the key, the indicator blinks green first and then blinks orange; After powering on, the indicator is green. Battery indicator status 1 It illuminates in orange color when batteries are charging; 2 It illuminates in green color when batteries are charged to full capacity; 3 The battery discharges with more than 20% electricity, and the indicator is green. 4 The battery discharges with less than 20% electricity, and the indicator blinks orange. 5 The battery discharges with less than 5% electricity, and the indicator blinks orange quickly. 6 When the battery is in non-charge/discharge status, the indicator is not on. The indicator is green at AC supply. AC indicator The indicator is off when batteries supplied. Standby indicator status Hard disk indicator The standby indicator blinks orange. Other status: light off The indicator light flashes in green when the hard disk is reading or writing. The indicator is off automatically in other situations. System Diagnosis and Support 10-1 10.1.2 Status of Whole Machine Status of whole machi ne Status definition and indicators Scan status In power status, the indicator is green; in Freeze status, the indicator is white or off. Enter or exit the scan status via [Freeze] key Froze n status In power status, the indicator is green; in Freeze status, the indicator is orange. Enter or exit the frozen status via [Freeze] key The standby indicator blinks orange. 1 short press the power button, then, the system enters into the standby status by choosing from the status popped on the screen. 2 If there is no operation for a period of time, the system would enter into the standby status automatically. Stand by status To enter the Patient Info interface The brightness of the monitor keeps the same; Scree n-save r status Power -off status The logo “mindray” moves around the screen. the indicator of the control panel is off. The system is frozen. Ultrasound imaging hardware system is in the dormancy mode. The system is on the power-off status (AC power is plugged in), and only the AC indicator is on. See battery indicator's description for battery indicator status. 10-2 System Diagnosis and Support There is no operation for the time set firstly, and then the system would enter into the screen-saver status from the frozen status automatically. Press the power button for a short time, and then the system is turned off by choosing from the status popped on the screen To exit the Patient Info interface The system restores to the frozen status after restarting by pressing the power button for a short time. When you press any keys on the control panel, the system would return to the frozen status, the brightness and the backlight of the control panel restore to the previous status. Start the system by pressing the power button for a short time 10.2 Get Whole Machine Started Power-on to the machine Press power button on control panel Temporary black screen Power-on indicator is on Power-on completes. BIOS starts. BIOS start-up graphics appears Windows operating system starts Windows start-up graphics appears 1.Backlight of control panel is on. 2.Power status indicators of IO back board are on. 3.The fan starts running. Windows logging graphics appears Hard disk indicator blinks Doppler starts Temporary black screen. Doppler start-up graphics appears (including progress bar) Some mode buttons become orange (B mode button) User interface System Diagnosis and Support 10-3 10.2.1 Power-on Process of Whole Machine Supplied by AC Basic operations Phenomenon Plug the power supply into line voltage Power indicator of minor control panel is on; battery indicator is on (battery); hard disk indicator and standby indicator are off. Power button on the main control panel Power-on indicator of main control panel blinks in green, and then is green. Power-on is completed. 1: The control panel backlight lights on. 2: The fan starts to run. After finishing hard disk initialization and logic configuring, PC enters into BIOS stage. The monitor appears in black screen for about 1 second. 10.2.2 The Start-up Process of BIOS Basic Procedures Basic phenomenon Self-test after the system power-on The LCD is in blank screen and the speed is fast during the stage. Initialization process & record system settings & provide the resident program library Display BIOS start-up display Load the operation system Display BIOS interface when loading. After completing the loading, the black screen appears. Then, WINDOWS interface appears. 10.2.3 Windows Start-up Basic Procedures Basic phenomenon Guiding the course of program loading The monitor appears in black screen now, and the time of the course is short. The course of testing and hard disk configuration The monitor appears in black screen now, and the time of the course is short. The course of the internal core loading The logo “mindray” appears. The course of logging on Same as the above Starting DOPPLER The company logo appears, and simultaneously progress bar displays the related information. 10-4 System Diagnosis and Support 10.2.4 The Start-up of Doppler 10.2.4.1 Procedure of Startup Windows app initialization Initialize hardware Peripherals owned by PC; initialization. Initialize PC software Initialize ultrasound hardware Initialize ultrasound software Initialization to ultrasound software Start-up, operations and applications related to ultrasound software are performed on this step. Initialization ends System Diagnosis and Support 10-5 10.2.4.2 Details of Procedures Step Procedures Increment Description Possible reason for starting stagnation Window start-up appmon starts Doppler Attach the path to configuration files Set Windows attributes Initialize display device, main interface, vocal, USB device representative Start bus device Backbone Dev and LPC No tips Initialize the time and multi-language functions. Initialize the external file system, network and drive Enumerate peripheral ports Configure timer, initialize soft interrupt, construct maintenance server, configure system static data In increments of 7. Start-up configurati on, XP system Configure system font Load layout information Initialize UI manager and UI icon library Initializing hardware Load boot-trap graphics, display progress bar; release package of configuration data; maintain data server Loading system preset Generate the server of local preset and system preset In increment of 1. Loading common exam preset Generate general data management of the exam mode In increment of 1. Loading exam preset Generate measure preset, peripheral and network, KMP package of images and the preset server of the network storage In increments of 4. Initializing locale Set area information, language, Font library, input method create control factory Config GUI layer Set menu item Initialize function library Create UICenter In increment of 1. Configure hard disk data / Initializing gui Configure application layer Keyboard initialization Configure user’s access and remote desktop management In increment of 1. Be careful of the keyboard / 10-6 System Diagnosis and Support Boot-trap graphics / Configure preset data Step Procedures Increment Description Initializing ultrasoun d peripheral Configure file dialog box Initialize print library Battery monitoring, PHV monitoring Load print task icon Configure low consumption Configure USB manager and burn manager Initialize video review device In increment of 1. Configure the external. Be careful of the battery. Initializing ultrasoun d image Create ECG receiving thread Set virtual machine; initialize virtual machine Create front-back object tree (ultrasys, etc) In increments of 2. Pod data Initializing ultrasoun d applicatio n Add function package of measurement menu Register application interface for the patient to be measured In increment of 1. Initializati on completed Configure the architecture of patient information management (UPatientApp) In increment of 1 / Enter Doppler interface In increment of 1 Patient information library Possible reason for starting stagnation / / Doppler interface / 10.3 Alarming and Abnormal Information The system has also alarming function, when the machine fails, it would pop up the alarming dialogue box, and simultaneously generate LOG file saved in the system log, which is saved in D disk: \M9\Log. Description: The asterisk “***” represents the time in LOG record. The format is: 2011-6-12 14:15:15 10.3.1 Power Error Alarming tips LOG record Suggestion “Warning! Battery operation error! The battery may be damaged” *** “Battery hot unplug during operation.” Avoid hot swapping of battery. *** “Left/Right Battery I2C error” The battery error occurs when the power is supplied by AC. Check the battery connection or replace the battery. ***“Left/Right Battery I2C The battery error “Battery communication error! Battery may not be used or battery capacity may not be displayed correctly” “Battery communication error, Please System Diagnosis and Support 10-7 connect AC power supply, or Power-off”" System will Power-off in 60s " “Battery over-temperature, Please connect AC power supply, or Power-off”" System will Power-off in 60s " error, Battery supply” occurs when the power is supplied by AC. Check the battery connection or replace the battery. *** “Left/Right Battery over-temperature, Current left/right temperature:?℃,Battery Manufacture Access value: left:0x????,right: 0x????" Use the adaptor to supply the power or shut down the device to make the battery cooler. ***“Left/Right Battery error! Battery Manufacture Access value: left:0x????,right: 0x????” Right or left battery is damaged or protected. It can be recognized via Manufacture Access value. If it is under protection, it would restore after a time period. If it is damaged, it needs to replace the battery. *** “Battery cycle is more than 300, Current cycle: left:??, right:??” The usage time of batteries is too long. It is recommended to replace the battery. “Battery error! Battery cannot be used!” N/A The battery status is displayed in “Preset”-“System Information”. See the table below. Battery status “GOOD” Condition No damage to the battery or the protection recoverable. Description The battery status is good, and can be used normally. The fully charged battery capacity (FCC) is larger than 40% of rated voltage. “WEAK” No damage to the battery or the protection recoverable. The fully charged battery capacity (FCC) is less than 40% of rated voltage. Discharge or charge the battery fully. Restore some of the battery capacity. Cycling times of the battery< 300 “RELACED” No damage to the battery or the protection recoverable. The fully charged battery capacity (FCC) is less than 40% of rated voltage. Cycling times of the battery > 300 10-8 System Diagnosis and Support Battery capacity goes down after long-time use. It affects the battery performance and endurance time. Replace the battery as necessary. “INVALID” “PROTECTED” Unrecoverable destructive protection of battery Permanent damage to the battery. Remind the user of replacing the battery. Recoverable protection of the battery The recoverable protection occurs to the battery. The battery recovers after a time period. Contact the service engineer for any questions. 10.3.2 Abnormal Voltage of System Power Alarming tips LOG record Suggestion The real-time battery will be out of power, please replacing it. *** System Monitor: Power supply alert! [XXX], Current voltage: [VVV] V, Limit voltage:[LLL]~[HHH]V *** System Monitor: Power supply alert! [XXX], Current voltage: [VVV] V, Limit voltage:[LLL]~[HHH]V N/A [XXX] represents voltage name, [VVV] represents the current value, and [LLL]-[HHH] represents the upper and lower limits. The voltage names respectively are: P2V5、N11V7、P3V3、P5V、 P1V2、P1V8 、AP5V6、AP3V6、P12V、P1V5、 AP2V、AP2V8、 P1V、P1V35 Replace button battery If a certain segment of the circuit is abnormal, or goes higher or lower, it should replace main board. 10.3.3 Abnormal Temperature Alarming tips “Temperature Alert” “Temperature Alert" The software starts the shut-down after the alert appears. LOG record *** System Monitor: Temperature Alert! [XXX], Current temperature: [VVV] ℃, Limit temperature: [LLL]-[HHH] ℃。 [XXX] represents voltage name, [VVV] represents the current value, and [LLL]-[HHH] represents the upper and lower limits. The temperature names respectively are: FPGA, CPU Suggestion Temperature name Turn the device off if the software is over-heated. Restart the device Check fan log record D: \M9\Log \ M9_Log.20XX-XX-XX.xml 20XX-XX-XX represents LOG’s date. Fan works well or not/check cooling conditions. System Diagnosis and Support 10-9 thermal sensor Hot spot name DSP F GA FPGA PC module CPU thermal sensor 10.3.4 Fan Error Alarming tips LOG record Suggestion *** System Monitor: Fan alert![XXX], Current speed : [VVV] rpm, Limit speed: [LLL] rpm The number of the fan is shown below (from left to right): “Ventilator requires maintenance, please contact the service!” Fan 1 Fan 2 Fan 3 Fan 4 Fan 5 Fan 6 Replace the fan/re-connect the circuit/clear off fan blocking. 10.3.5 PHV Error Alarming tips Alarm! High-voltage transmission is abnormal, and images display normally! LOG record *** HARDWARE_WAR(0xB1).PHV hardware protection, HV_PRN_N (+-100V) *** HARDWARE_WAR(0xB1).PHV hardware protection, PHV_OVP_N (OverVoltage Protection) *** HARDWARE_WAR(0xB1).PHV hardware protection, PHV_OCP_N (OverCurrent Protection) 10-10 System Diagnosis and Support Suggestion Cut off the power supply after shutting down the device. Check the restoration of the system. Otherwise, it is necessary to replace PHV power supply board of the front end. *** [CCC]([HH]).[XXX] supply voltage error. [XXX] volt is [PPP] V (upper limit is [LLL]V). in which [CCC] refers to the frame name of current alarming protocol and [HH] refers to frame header. [XXX] refers to the name of high voltage, such as: PHV-1P, PHV-1N, PHV-2P, PHV-2N, CW-P and CW-N. [PPP] refers to absolute value of current voltage. [LLL] refers to upper limit of preset voltage. *** [CCC]([HH]).[XXX] supply voltage error. Current volt is [PPP] V, out of range 95V~105V. in which [CCC] refers to the frame name of current alarming protocol and [HH] refers to frame header. [XXX] refers to the name of high voltage, the range of which is from +100 V to -100 V. [PPP] refers to absolute value of current voltage. Restart the device to check whether the system can work again. Otherwise, it is necessary to cut off the power supply after shutting down the device. If the problem still exists, replace front power supply board. *** PHVCURRENT_WAR(0xB2).Channel [XXX] supply current error. Channel [XXX] current is [PPP]mA. [XXX] refers to channel number of voltage: 0-3. [PPP] refers to current value of current voltage channel. *** [CCC]([HH]).PHV volt abnormal protection. {PHV-1P volt:[PPP]V, PHV-1N volt: [PPP]V,} PHV-2P volt: [PPP]V, PHV-2N volt: [PPP]V. in which [CCC] refers to frame name of current alarming protocol and [HH] refers to frame header of protocol. [PPP] refers to absolute value of current voltage. {..} indicates that PHV-1P and PHV-1N voltage are not used (such as CW-Multiplex mode). It can be ignored. *** [CCC]([HH]).CW volt abnormal protection. CW-P volt: [PPP]V, CW-N volt: [PPP]V. in which [CCC] refers to frame name of current alarming protocol and [HH] refers to frame header of protocol. [PPP] refers to absolute value of current voltage. Cut off the power supply after shutting down the device. Then, restart the device. Check the restoration of the system. Otherwise, it is necessary to replace PHV power supply board. 10.3.6 Other Errors Alarming tips Fail to open the file "SystemConfiguration.ini", and please check HDD data! LOG record N/A Suggestion Re-install the system software. 10.4 Self-test 10.4.1 Self-test Introduction The self-test function, adopted by M9 series products, is used to test the connection of hardware board, running status of the device. According to the access authority and tests, there are three System Diagnosis and Support 10-11 types of tests: production self-test, maintenance self-test and user self-test. This chapter describes the maintenance self-test and user self-test in details. 10.4.2 Operation Procedure of Maintenance Self-test Note: Before entering system self-test, all tasks running on Doppler should be completed, otherwise the self-test system fails to respond. It is recommended to start self-test software to perform the test after the system is generated. 1. Switch account, type service password and service account to log in. 2. Select [Setup]-[Maintenance]-[Setup]. Click [Self Test] out of dialog box. Note: If the system is in Chinese, the self-test performs Chinese system self-test. If the system is not in Chinese, the self-test performs English system self-test. 10-12 System Diagnosis and Support 3. The booting screen of system self-test appears. Figure 10-1 Booting screen of system self-test 4. Configure corresponding preset items on maintenance self-test interface. After finishing the configuration, click [Start] to perform self-test. See the table below: Button Name Description [Open All] Click to unfold all items that are folded. [Close All] Click to fold all items that are unfolded. System Diagnosis and Support 10-13 [Default] The system performs item tests by clicking it. [Select All] Select all test items by clicking it. [Select None] Cancel the test item by clicking it. [Continue/Stop] One button for two operations [Continue] and [Stop]. If you click [Continue], the test continues even though a test item fails during the test; however if you click [Stop], the test stops once a test item fails during the test. [Start] Click to perform tests for checked items one by one while the button turns to [Stop]. During the test, if you click [Stop], the test stops. After the test is completed, the [Stop] button turns to [Start], and waits for the next test. [Next Fail] After completing the test, click [Next Fail]. The program searches for the failed test item from message list, and rearrange it to the top of the test information list. If the program reaches the bottom, it starts to search from the top of the list again. [Clear History] Click to clear off the test data in Testitems and Messages and to initialize the system structure diagram to original status. [Loops] It is used to perform loop test. Select the check box and type the times for loop test in the box on the right of screen, and perform the test according to the times typed. If the loop times are less than 0, it continues the loop test before the user stops it or encounters the error. [Save Report] The dialog box to remind the user of exporting the report appears by clicking the button. Plug the removable storage device, and select corresponding logic drive, and then click [OK]. The test data is saved to the selected root directory. The button is disabled if the removable storage device is not plugged in. [Shut Down] Close the program, and shut down the device. The system reminds the user of saving the test report to removable storage device when shutting down the device. Remarks: the test item includes parent-test item according to the board from the test area. There are sub-test items belonging to parent test item. It can be customized according to the requirement. If the test item is ticked ( ), this item is in the test list; otherwise, this item is not in the test list. When a parent item is selected, all the sub items of this item are selected by default; otherwise, when deselecting a parent item, all the sub items of this item are deselected by default. Description: The user can see production, maintenance and user self-test interface from the screen. The production and maintenance self-test interfaces can be divided into five areas. 10-14 System Diagnosis and Support Figure 10-2 Maintenance self-test interface 5. Self-test status display: When the program is running, the version and release date, M9 SelfTest Software for Manufacture Version: xx; Release Date: YYYYMMDDXX, will be displayed on the left side of the status bar. During the test, the software version in the status bar becomes the name of current test. The current test progress and overall test progress are displayed on the status bar. Beyond that, the status bar tests the rest time in real-time. Figure 10-3 Sketch of test status bar 6. Monitoring information bar Current time, CPU ocCPUation rate, CPU 1 temperature, CPU 2 temperature, CPU 3 temperature, CPU 4 temperature, DC-DC temperature, AFE temperature and DSP FPGA junction temperature display on monitoring information bar. If the temperature exceeds the working temperature, the temperature status in progress bar appears in red. 7. System dialog box The element in the system dialog box changes as the color of test result changes in the test process. If the test fails, the color of the element becomes red; if the test succeeds, it becomes green. If the color of the element does not change, it indicates the test does not proceed. 8. Test information The test result is displayed after the test is completed. Green PASS indicates the pass of the sub-item. Red FAIL indicates the failure of the sub-item. If the item has not been tested, it appears in grey Skip. If the board and the assembly are absent, it appears in grey NaN. Red Error appears as the test item error occurs. The test result of parent test item is the aggregate for the test result of all selected sub-test items. If there is FAIL test in the selected list, the test result of parent test item is FAIL. As long as the test result of the selected item is PASS, the test result of parent test item is PASS.As shown in the following figure. System Diagnosis and Support 10-15 Figure 10-4 Display of test result in Testitems table Click each test item in Testitems list. The program search for corresponding test result of test item and displays it in details, as shown below. Figure10-5 Display of test result in Messages table The number to the test item appears in front of the name of test item. The number format is: ZXXYY and all test items are started with "Z". XX represents sequence number of the first level for item test and YY represents the second level. For example: the number of System Voltage Test is Z0210, in which 02 is the second test item of the first level directory in Main Board, and 10 is the tenth test item of System Voltage Test in Main board. 10.4.3 User Self-test Start the device. Press <Setup> button. Select [Maintenance]-[Setup]-[Self Test] to perform the operation. 10-16 System Diagnosis and Support s m e ti ts e t f o ae ra ya l p si D g n ri o it n o M o f in s u t ra atS b Figure 10-6 User self-test interface There are three divisions in user self-test interface: display area of self-test item, monitoring information bar and status bar. The functions on monitoring information bar are same with those on user self-test interface. The self-test area only displays the item that has been tested, but not the test result. Item Description [Start/Stop] button Click to perform tests for checked items one by one while the button turns to [Stop]. During the test, if you click [Stop], the test stops. After the test is completed, the [Stop] button turns to [Start], and waits for the next test. [Test Report Save Location] Check box Displays the logic drive of removable storage medium (USB flash disk, removable hard disk, etc) connecting to the system. The check box is disabled in test process. If there is no removable storage medium, click the control which reminds the user of inserting the removable storage medium. [Save Report] button Save the test data to the root directory of selected logic drive. The button is disabled when the logic drive is deselected or in test process. [Shut Down] button Close the program, and shut down the device. The system reminds the user of saving the test report to removable storage device when shutting down the device. Start the test when entering user self-test. After finishing the test, the number of test item only displays on the screen if there is FAIL test item. For example, if System Voltage Test fails, only does Z0210 display on the screen. It is available for user to notice that Z0210 corresponds with test item System Voltage Test by viewing Appendix. The dialog box of PASS appears only with all test items passing, as shown below: System Diagnosis and Support 10-17 10.4.4 Test Report 10.4.4.1 Test Report The default format of test report is HTML. The test report can be browsed via Internet Explorer. The format is shown below: The test item list lies on the left side of the report and is classified according to test results. Click the test item on the left side of the report. The test data of the item displays in the report. The test information lies on the right side and includes: 1. Report name; 2. The time that report generates, and software version information; 3. Screenshot of system structure diagram; 4. System information; 5. Highest temperature; 6. Test item data of FAIL test (if there is no FAIL test item, the directory does not unfold); 7. Test item data of PASS test (if there is no PASS test item, the directory does not unfold); 8. Test item data of Skip test (if there is no Skip test item, the directory does not unfold). Test data format of each test item is shown below: 10-18 System Diagnosis and Support In which, [Z0202] refers to the index of test item; [Board/Module] refers to the board and the module that test item lies in; [Test Result] refers to the result of test item; [Information] refers to the information of test item. 10.4.4.2 Test Data Storage Take the time as the report name, and compress it into Zip file. The test report is saved under the directory of D:\M9\Log\SelftestReport. 20 copies of test reports at most. Non-loop test The test result will be compressed into Zip file and saved under the directory of D:\M9\Log\SelftestReport to non-loop test. One Zip file owns one report. Loop test Click [Save Report] after finishing the test. The loop test is compressed into a Zip file package and saved under the directory of D:\M9\Log\SelftestReport. There are N reports in Zip file package where the reports are put into the folder of Test Report Loop_N. The test results are PASS and FAIL. N is the loop times of the test. 10.4.4.3 Test Data Export 1. Plug USB flash disk or removable storage medium to the port of the device. 2. The user chooses the logic drive of removable storage medium. Click [Save Report] on test interface to export the test data to root directory of the drive, and name it as Test Report. The dialog box appears after the test report is saved successfully. 3. See Appendix C for details of test items. Note: It is not operational for users if there is no removable storage medium to the computer. System Diagnosis and Support 10-19 11 Care and Maintenance 11.1 Overview The maintenance procedure in this chapter is for recommendation. 11.1.1 Tools, Measurement Devices and Consumables Table 11-1 List for Tools and Measurement Devices Tools/Measurement Devices Qty. Remarks Plastic and resin container 1 Used to contain the physiological saline and two probes available in the container. Soft brush 1 The size is similar to that of the brush. The material of the brush should be soft. Small plastic bowl 1 Used to contain soap-suds Safety testing device 1 See Appendix A for details Inner hexagon spanner 2 Inner hexagon spanner 8 and inner hexagon spanner 6 Table 11-2 Consumable List Consumable Qty. Aluminum foil About 1 meter long Physiological saline About 1000 mL Remarks Reach the half of the container to submerge the probe in the saline. (See Appendix A for details) (Concentration 0.85% to 0.95%) Mild soap-suds About 400 mL Dry soft cloth 5 pieces Care and Maintenance 11-1 11.1.2 Routine Maintenance Items Table 11-3 The list for maintenance items and maintenance frequency No. Item Frequency Method 1 Dust-proof cover cleaning 1 time/month See Chapter 12.2.1 2 The monitor cleaning 1 time/month Ditto 3 Trackball cleaning 1 time/month Ditto 4 Control panel cleaning 1 time/month Ditto 5 Probe cleaning (head of the probe) Every time after use Ditto 6 Probe cable and connector cover cleaning 1 time/month Ditto 7 Holder cleaning (including probe holder and ultrasound gel holder) 1 time/month Ditto 8 Cover cleaning 1 time/month Ditto 9 Peripherals cleaning 1 time/month See Chapter 11.2.2 10 Probe appearance check 1 time/day See Chapter 11.3.1 11 Check for power supply cable, power supply plug and circuit breaker. 1 time/month See Chapter 11.3.1 12 Battery check 1 time/3-6 month See Chapter 11.3.1 13 Check for peripherals and optional functions 1 time/year See Chapter 11.3.3 14 Mechanical safety check 1 time/year See Chapter 11.3.4 15 Check for electrical safety 1 time/year See Appendix A 11-2 Care and Maintenance 11.2 Cleaning 11.2.1 System Cleaning 11.2.1.1 Flow of Cleaning Shut down the system; unplug power supply cable Clean dust-proof mesh Clean the monitor Clean the trackball Clean the control panel Clean the probe Clean the holder Clean the cover Fig 11-1 The View of cleaning maintenance WARNING: Before cleaning the system, be sure to turn off the power and disconnect the power cord from the outlet. Otherwise electric shock may result. 11.2.1.2 Content 1. Dust-proof cover cleaning Include system dust-proof mesh of main unit and dust-proof mesh of trolley. Tool: soft brush Method: a) Disassemble dust-proof cover before cleaning. Dust-proof mesh of trolley: open the clasp of dust-proof mesh. Push the dust-proof mesh towards the arrow to let it fall off completely form dust-proof slot. Then, take it out. Care and Maintenance 11-3 Dust-proof mesh of main unit: take out the dust-proof mesh of the main unit. Dust-proof mesh of main unit on the right side CAUTION: 2. Please clean all dust-proof covers of the system periodically (1 time per month); otherwise, system damage may result. Cleaning times can be increased when the system is used in the open air or somewhere dust is more. Clean the monitor (touch screen) Tool: dry soft cloth, clean water and soap-suds. Method: Use dry clean soft cloth to clean monitor and touch screen. If there are any stains, use dry soft cloth or mild soap-suds to clean off. Then, air dry it. 3. Trackball cleaning As a part of human-computer interaction, the trackball is easy to get the dust into internal module in the usage. It is necessary to perform the routine maintenance to ensure the performance. If the cursor does not work well, it would be possibly contaminated by dust. Tool: tissue, dry soft cloth, mild soap-suds Method: a) Disassembling the trackball: Turn the trackball ring about 35°counterclockwise until it lifts. Take out the ring and the rotary ball (Be careful not to drop the ball).If it fails to hold the trackball by hand, it is possible to use adhesive tape to remove it. The disassembly procedures are shown below: 11-4 Care and Maintenance b) Cleaning: Clean the two long shafts, the bearing, plastic cover and the internal area of clamping ring (see the illustration below) with clean soft dry cloth or tissue. c) Restoration installation: Put the trackball into that. The long axis of clamping ring aims at the slot of trackball’s cover. Press the bulges of the clamping ring with fingers. Rotate the ring 35 degrees clockwise to lock it. The ring is installed well if the position of two bulges on the ring is perpendicular to device’s panel. See the illustrations below. Clamping ring clasp 4. Control Panel Cleaning Care and Maintenance 11-5 Tool: dry soft cloth, mild soap-suds Method: Use dry soft cloth to clean control panel (including keystroke, encoder, locking lever).Or use mild soap-suds to clean off the stains, and then use dry clean soft cloth to dry it. If it is difficult to clean the control panel, please remove the caps of the encoders, and then use mild soap-suds to clean off. Note: Keyboard on the control panel should be cleaned periodically; otherwise, keys maybe blocked by dirt and buzzer dings. Keys don’t work. 5. Cleaning the probe Tool: dry soft cloth, mild soap-suds Method: a) Use dry soft cloth to clean off the dust on probe head, connector cover and its cables. b) Use soft brush to clean off the dust on the terminal of the probe connector. c) If there are any stains, use the mild soap-suds to clean off the dust on the appearance of the cables and connector cover. Then air dry it. Note: the probe connector cannot be clean with wet cloth. 6. Holder cleaning Tool: dry soft cloth, soft brush, mild soap-suds Method: a) Use soft dry cloth to clean off the dust on probe and gel holder and its gap; use the soft brush to clean off the dust from gaps and probe holders of smaller intracavity probes. b) If there are ant stains, remove the probe holder. Use mild soap-suds to clean off the stains. Reinstall it after being air dried. c) Gel heater: unplug the cable of gel heater, and take off the heater. Use the mild soap-suds to clean the heater. Use soft brush to clean the holes. Use soap-suds to clean off the stains, and reinstall it after air-dry. 7. Device cover cleaning Tool: dry soft cloth, mild soap-suds Method: Use soft cloth to clean off the dust on the device cover (the part exposed).Or use mild soap-suds to clean off the stains and air dry it. Note: it is preferred to use soft brush to clean off the dust on the port or socket rather than wet cloth (such as probe socket, IO board and ports on power supply board). 11-6 Care and Maintenance 11.2.2 Peripherals Cleaning Perform the cleaning according to the reality. The test items without the configurations can be ignored. Table 11-4 List for peripherals cleaning Item Content Process Description 1 Color/Black/White video Use soft dry cloth to clean off the dust and stains on the cover. Remove the cover to clean the internal of the printer. It is necessary to abide by the operation procedures in Operator’s Manual to clean the printer. printer 2 Graph/text printer Use soft dry cloth to clean off the dust and stains on the cover. Remove the cover to clean the internal of the printer. It is necessary to abide by the operation procedures in Operator’s Manual to clean the printer. 3 Footswitch Use the dry soft cloth and soap-suds to clean off the dust and stains on footswitch and the cables. 4 Barcode reader Use dry soft cloth to glass board of the scanner, and the clean off the dust o the cables and the bracket. Please abide by the operation manual on the scanner to perform the cleaning. 11.3 Check 11.3.1 General Check Table 11-5 The list for general check No. Content Method Visual estimation, check whether there are any cracks and distention to probe head. 1 Probe Visual estimation, check whether there is aging or peeling; Visual estimation, check whether there is bending, damage or missed stitch to the probe’s connector. 2 Power supply cable and socket Visual estimation, check whether there are creases, cracks or aging to the power supply cable; Manual operation, check whether the plug of the power supply is fixed enough. No loose or crack occurs to it. The retaining clamp of power supply cable works well. Checking battery performance routine: 3 Battery Charge the battery when the device is powered on: if the battery capacity reaches 100% or the battery continues to be charged, it indicates the battery works well. If the battery capacity is less than 90%, the time to increase 1% of battery capacity is less than 5 minutes. If the battery capacity is more than 90%, it need more to time to charge the battery. In stand-by status, the standby indicator shows the status of the battery. Care and Maintenance 11-7 11.3.2 System Function Check The system function checking is not required during Preventive Maintenance. Engineer or Customer may use it as part of their product Quality Assurance Program tests. Table 11-6 System function list No. Content Method 1 B mode Verify the basic operation in B mode. Check the basic software and hardware assembly affecting B-mode operation. 2 Color mode Check the basic operation in Color mode. Check the basic software and hardware assembly affecting Color mode operation. 3 Doppler mode (PW/CW) Verify basic operation in Doppler mode. Check the basic software and hardware assembly affecting Doppler mode operation. 4 M mode Check the basic operation in M mode. Check the basic software and hardware assembly affecting M-mode operation. 5 Measurement (General measurement, optional application measurement for 2D, M, Doppler) Gray scale scanning on the body mark mode verifies distance and the accuracy of calculation using the test assembly and checks test precision along with performance test. 6 Keyboard test Starting the keyboard test is used to check if all control keys are normal. 7 LCD Please refer to LCD checking methods to check LCD display and parameters adjustments are normal. 8 Software menu testing Testing software menu display is to see if they works normally after entering interfaces and menus See Chapter 5.4~5.5 11.3.3 Check for Peripherals and Optional Functions If there is no relevant module or option in the system configuration, the relevant check can be ignored. Table 11-7 Peripheral and option checking list Item 1 Content Color/Black/White video printer Method Check whether the output of video printer works well. 2 Graph/text printer Check whether the output of graph/text printer works well. 3 Footswitch Check whether the footswitch works as the system configures. 4 DVD-R/W Check whether DVD-R/W works well (burning, read/write and openness). 5 Barcode reader Check whether the reader works well and whether the output is correct. 6 DICOM Check whether DICOM works well, and verify if sending images to DICOM server by shortcut key is normal. 11-8 Care and Maintenance Item Content Method 7 ECG module Check user’s basic operation. Verify the implementation of ECG module. See Chapter 5.3 11.3.4 Mechanical Safety Inspection Mechanical safety inspection is mainly used to check mechanical strength and mechanical function of the key assembly of ultrasonic system. The mode of test evaluation mainly is: Perform the evaluation by means of visual check and operating check, if the check result cannot pass, the system is in abnormal status now. Stop using the system and adopt proper measures. The test flow is as following: Check casters of cart (optional) Check the connection of cart casters Check the handle of cart (optional) Check the supporting part of cart Check enclosure of main unit Check handle of main unit Check control panel And turning mechanism Check other mechanics Fig Mechanical Safety Inspection Flow The table of Mechanical Safety Check: Care and Maintenance 11-9 NO. Item 1. Casters of cart Method a) Visually check to confirm there is no any crack. b) Operate the casters to confirm the locking and releasing functions are normal. a) Visually check to confirm that there is no skewness and the connecting screws are free of breakage or falling off. b) Check with the spanner to make sure that there is no looseness between the caster and the base connection screw. a) Check by sight if the handle has cracks. b) Use a wrench to check if the handle is loose. Tool none Inner hexagon wrench 6 2. Connection of cart casters 3. Handle of cart 4. Cart supporting parts a) Use hands to check if the supporting parts are loose. none 5. Enclosure of main unit b) Check by sight if there is any crack. none a) Visually check to confirm there is no any crack. none b) Rock the handle gently and then lift the ultrasound machine to confirm that the handle is free of looseness and it can accept normal force. 6. Handle 7. Control panel and turning mechanism 8. Other mechanical structures Open and close the control panel to see if it is free of looseness or separated from the main unit. none Check to confirm that there is no looseness to other mechanical parts, no crack to cover and no conductive parts show in sight. none 11-10 Care and Maintenance 12 Troubleshooting of Regular Malfunctions 12.1 Troubleshooting as the System is Disabled to Power On 12.1.1 Related Modules or Boards No. Descriptions Remarks 1 Power supply adapter / 2 Battery assembly / 3 Main board / 4 CPU assembly / 12.1.2 Key Points Supporting Troubleshooting No. Key points supporting troubleshooting 1 Power-on status indicator 2 AC indicator Remarks Backlight of the power button Located on control panel 12.1.3 Troubleshooting as the System is Disabled to Power On No. Fault Description 1 System power supply adaptor 1 No AC input AC power indicator remains off; The system starts to work, but it turns out that the battery supplies the power for the system. Cause Analysis 2 Error from power supply adaptor Solution 1 Re-check the connection of AC 2 Replace the power supply adaptor Troubleshooting of Regular Malfunctions 12-1 2 AC indicator: on; Power on/off indicator: the indicator is off or blinks after pressing the button. 3 AC indicator: on; Power on/off indicator: blinks after pressing the power button; 4 When connecting to the power supply adaptor, the system works well. If not connecting to the power supply adaptor, the system does not work only with the supply of the battery. Error from main board of power supply; Replace the main board. Main board of power supply Replace CPU module responds to the power on/off, but CPU module does not respond to the power on/off module. The possibility for CPU module error is comparatively higher. 1 Low battery capacity 1 Charge the battery module; 2 Battery module error 2 Replace the battery module 12.2 The System Cannot Perform Troubleshooting 12.2.1 Related Modules or Boards No. Descriptions Remarks 1 Main board / 2 CPU assembly / 3 SSD / 12.2.2 Key Points Supporting Troubleshooting No. Key points supporting troubleshooting Remarks 1 Character and progress status during the starting of the system / 2 Alarm and prompts during the starting of the system / 3 Backlight status during power on the control panel / 4 Display mode of the LCD / 12-2 Troubleshooting of Regular Malfunctions 12.2.3 The System Cannot Perform Troubleshooting No. Fault Description Cause Analysis Solution 1 The backlight on the control panel appears normal. The monitor is in black screen. There is no display when connecting to peripherals via HDMI. System powers on normally, Replace CPU module enters BIOS self-checking but BIOS screen does not display. CPU module failure. 2 BIOS start-up graphics is normally displayed, but it cannot be kept on CPU module error Replace CPU module 3 “OPERATING SYSTEM NOT FOUND” appears. Loading operation fails. SSD and root directory of SSD in operation system are damaged. Restore the operating system. If fails, replace SSD. 4 BIOS start-up graphics appears, and then in black screen. Unavailable to load the system. The system directory of SSD may be damaged. Restore the operating system. If fails, replace SSD. 5 System Doppler start-up graphics displays but cannot be kept on. Fails to load Doppler software. SSD or system software of SSD may be damaged. Restore the operating system. If fails, replace SSD. 12.3 Image Troubleshooting 12.3.1 Related Modules or Boards No. Descriptions Remarks 1 PHV power supply board / 2 TP64 board / 3 Main board / 12.3.2 Key Points Supporting Troubleshooting No. Key points supporting troubleshooting Remarks 1 Image feature, including dark strips and noise / 2 The imaging features of various probes / Troubleshooting of Regular Malfunctions 12-3 12.3.3 Image Troubleshooting No. Fault Description Cause Analysis Solution 1 No echo to PHV power supply board error ultrasound image. The probe can recognize but without the echo. Replace PHV power supply board 2 Dark strips appear on Probe malfunction, e.g., array B image damage, etc. Replace the probe; Replace the probe to eliminate the error. If dark strips appear in the near field and distribute regularly, Replace TR64 or main board; transmission channels cannot generate transmission waveforms; If dark strips appear in the far field and distribute regularly, Replace TR64 or main board; Receiving channel error. Some channels do not receive or produce echo signal. 3 Noise appears in B image Probe malfunction. Replace with different probes to check the problem. Replace the probe; Other electrical equipment in the Confirm the cause of failure by voltage is working, so that the probe turning off electrical equipment may be interfered on the floor; of all peripherals connected to Displays ripple-shaped interference the system signal on the image 12.4 Troubleshooting Control Panel 12.4.1 Related Modules or Boards No. Descriptions Remarks 1 Control panel assembly / 2 2116 keyboard / 3 TGC Board / 4 Trackball / 5 Silicon keystroke of keyboard / 12.4.2 Key Points Supporting Troubleshooting No. Key points supporting troubleshooting 12-4 Troubleshooting of Regular Malfunctions Remarks 1 Backlight of control panel To confirm if the control panel is powered on normally; 2 Key sound of the control panel. To confirm if the buzzer works normally 3 Response to function keys on control panel / 4 2116 general response to the buttons on small keyboard To confirm if it is digital keyboard error or control panel assembly error. 5 Response to trackball operation / 6 Response to the sliding potentiometer To confirm if it is TGC board error or control panel assembly error. 12.4.3 Troubleshooting Control Panel No. Fault Description Cause Analysis Solution 1 Buzzer alarms Key blocked; Check the control panel for key block 2 Some or a certain key fails Control panel PCBA error or silicon Replace the control panel button error; assembly or replace silicon buttons; 3 Some or a certain key on the small keyboard fails. Small keyboard Replace the small keyboard 4 Trackball failed or abnormal Dirt or obstacles jam in the trackball groove Open and clean the groove Improper setting of trackball speed Make a proper preset in system preset; Degenerated trackball performance 5 Replace the trackball Control panel buttons TGC board error work well, but individual TGC button fails. Replace TGC board. TGC buttons all fail Replace control panel Control panel error 12.5 Troubleshooting LCD Display 12.5.1 Related Modules or Boards No. Descriptions Remarks 1 Display (monitor) assembly Attached 2 Main board 3 CPU assembly Troubleshooting of Regular Malfunctions 12-5 12.5.2 Key Points Supporting Troubleshooting No. Key points supporting troubleshooting Remarks 1 Backlight of the LCD More evident in the darkness 2 Display the status via HDMI connecting to peripherals; / 12.5.3 Troubleshooting Monitor No. Fault Description Cause Analysis Solution 1 The power-on of the control panel is normal. Response to operation buttons. LCD error Replace the LCD. Main board error Replace the main board. CPU assembly error Replace CPU module No display (blank screen) on the LCD; Displays normally via HDMI connecting to peripherals; 2 The power-on of the control panel is normal. Response to operation buttons. No display (blank screen) on the LCD; Displays normally via HDMI connecting to peripherals; 3 The power-on of the control panel is normal. No response to operation buttons. No display (blank screen) on the LCD; No display appears via HDMI connecting to peripherals; 12.6 Troubleshooting for ECG Module 12.6.1 Related Modules or Boards No. Descriptions Remarks 1 ECG board / 2 Main board / 12.6.2 Key Points Supporting Troubleshooting No. Key points supporting troubleshooting Remarks 1 Wave features of ECG signal / 12-6 Troubleshooting of Regular Malfunctions 12.6.3 Troubleshooting for ECG Module No. Fault Description Cause Analysis Solution 1 Fail to open ECG related functions ECG board error Replace ECG board. 2 Open the Abnormal ECG lead or ECG module corresponding ECG function, and the wave form is displayed as a line or abnormal wave shape. Replace ECG lead or ECG module. Troubleshooting of Regular Malfunctions 12-7 Appendix A Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations. All tests can be performed using commercially available safety analyzer test equipment. These procedures assume the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer. Other popular testers complying with IEC 60601-1 used in Europe such as Fluke, Metron, or Gerb may require modifications to the procedure. Follow the instructions of the analyzer manufacturer. The consistent use of a safety analyzer as a routine step in closing a repair or upgrade is emphasized as a mandatory step if an approved agency status is to be maintained. The safety analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line voltage and grounding, as well as total current loads. Electrical Safety Inspection A-1 ELECTRICAL SAFETY INSPECTION 1- Power Cord Plug TEST PROCEDURE The Power Plug The Power Plug Pins No broken or bent pin. No discolored pins. The Plug Body No physical damage to the plug body. The Strain Relief No physical damage to the strain relief. No plug warmth for device in use. The Power Plug No loose connections. The Power Cord No physical damage to the cord. deterioration to the cord. The Power Cord No --For devices with detachable power cords, inspect the connection at the device. --For devices with non-detachable power cords, inspect the strain relief at the device. A-2 Electrical Safety Inspection ELECTRICAL SAFETY INSPECTION 2- Device Enclosure And Accessories TEST PROCEDURE Visual Inspection No physical damage to the enclosure and accessories. No physical damage to meters, switches, connectors, etc. The Enclosure and Accessories No residue of fluid spillage (e.g., water, coffee, chemicals, etc.). No physical damage to probe head (e.g., crack) No loose or missing parts (e.g., knobs, dials, terminals, etc.). Contextual Inspection No unusual noises (e.g., a rattle inside the case). The Enclosure and Accessories No unusual smells (e.g., burning or smoky smells, particularly from ventilation holes). No taped notes that may suggest device deficiencies or operator concerns. Electrical Safety Inspection A-3 ELECTRICAL SAFETY INSPECTION 3- Device Labeling TEST PROCEDURE Check the labels provided by the manufacturer or the healthcare facility is present and legible. Main Unit Label Integrated Warning Labels Slope and High Voltage Caution Label Don’t Stress Label A-4 Electrical Safety Inspection NOTE: “4-protective grounding impedance” testing item is applicable for M9 portable ultrasound system with UMT-500Plus trolley (configured with power supply), and is not applicable for unaccompanied M9 system or M9 system with UMT-500 trolley (without power supply). ELECTRICAL SAFETY INSPECTION 4- Protective Earth Resistance VOERVIEW Protective Earth Resistance is measured using the RED test lead attached to the DUT Protective Earth terminal or Protective Earth Metal enclosure or equipotential terminal. Select the test current by pressing SOFT KEY 3 to toggle between 1AMP, 10AMP, and 25AMP. The front panel outlet power is turned off for this test. The following conditions apply: L1 and L2 Open. TEST PROCEDURE Prepare 1) First select the test current that will be used for performing the Protective Earth Resistance test by pressing AMPERES (SOFT KEY 3). 2) Connect the test lead(s) between the RED input jack and the GREEN input jack. 3) Press CAL LEADS. The 601PRO will measure the lead resistance, and if less than 0.150 Ohms, it will store the reading and subtract it from all earth resistance readings taken at the calibrated current. 4) If the calibration fails, the previously stored readings will be used until a passing calibration has occurred. Warning During Earth Resistance testing, the DUT must be plugged into the 601PRO front outlet. If the DUT fails Earth Resistance, discontinue tests and label the device defective. Perform the Test 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO Electrical Safety Inspection A-5 ELECTRICAL SAFETY INSPECTION 4- Protective Earth Resistance front panel outlet. 2) Attach the 601PRO RED input lead to the device’s Protective Earth terminal or an exposed metal area. 3) Press shortcut key 3. The Protective Earth Resistance test is displayed. 4) Press SOFT KEY 3 to select a test current (1AMP, 10AMP, or 25AMP). The selected test current is displayed in the upper right corner of the display. 5) Press START TEST to start the test. The test current is applied while resistance and current readings are taken. This takes approximately 5 seconds. 6) Press the print data key at any time to generate a printout of the latest measurement(s). Note When "Over" is displayed for Ohms, this signifies that a valid measurement was not obtained because either an open connection was detected or that the measurement was not within range. Readings greater than 9.999 Ohms will be displayed as Over. Failure Once it reaches the limitation, stop using equipment. Check the protective earth connection between Protective Earth terminal and Protective Earth Metal enclosure and equipotential terminal; Retest and inform the Customer Service Engineer for analysis and disposal if still fail. LIMITS ALL COUNTRIES R = 0.2Ω Maximum A-6 Electrical Safety Inspection ELECTRICAL SAFETY INSPECTION 5- Earth Leakage Test OVERVIEW Run an Earth Leakage test on the device being tested before performing any other leakage tests. Leakage current is measured the following ways: ♦ Earth Leakage Current, leakage current measured through DUT outlet Earth ♦ Earth Leakage Current AP-EARTH (ALL Applied Parts connected to Earth), leakage current measured through DUT outlet Earth There is no need to attach a test lead; the 601PRO automatically connects the measuring device internally. TEST PROCEDURE Perform the Test 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device. Attach the device's applied parts to the 601PRO applied part terminals if applicable. Press shortcut key 4.The Earth Leakage test appears on the display, and the test begins immediately: 2) 3) 4) SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse. SOFT KEY 2 toggles the DUT outlet from Earth to No Earth. SOFT KEY 3 toggles the DUT outlet from L2 to No L2. SOFT KEY 4 toggles the AP to Earth to No AP to Earth. Press the print data key at any time to generate a printout of the latest measurement. Figure 1 Earth leakage test Electrical Safety Inspection A-7 ELECTRICAL SAFETY INSPECTION 5- Earth Leakage Test Failure Check any short-circuits of the Y capacitor on power unit. Replace a new one if any portion defective. Check any broken of the Power Unit. Replace a new one if any portion defective. Inspect mains wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. Inspect mains wiring for bad crimps, poor connections, or damage. If the leakage current measurement tests fail on a new unit and if situation cannot be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal. LIMITS IEC60601-1:: 500 μA Normal Condition 1000 μA Single Fault Condition A-8 Electrical Safety Inspection ELECTRICAL SAFETY INSPECTION 6- Patient Leakage Current OVERVIEW Patient leakage currents are measured between a selected applied part and mains earth. All measurements may have either a true RMS. TEST PROCEDURE Prepare Perform a calibration from the Mains on Applied Part menu. The following outlet conditions apply when performing this test: Normal Polarity, Earth Open, Outlet ON Normal Polarity, Outlet ON Normal Polarity, L2 Open, Outlet ON Reversed Polarity, Outlet ON Reversed Polarity, Earth Open, Outlet ON Reversed Polarity, L2 Open, Outlet ON Warning If all of the applied parts correspond to the instrument type, the applied parts will be tied together and one reading will be taken. If any of the applied parts differ from the instrument type, all applied parts will be tested individually, based on the type of applied part. This applies to Auto and Step modes only. Perform the Test 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device. 2) Attach the applied parts to the 601PRO's applied part terminals. 3) Press shortcut key 6. The Patient Leakage test is displayed, and the test begins immediately. 4) Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current. 5) Modify the configuration of the front panel outlet by pressing the appropriate SOFT Electrical Safety Inspection A-9 ELECTRICAL SAFETY INSPECTION 6- Patient Leakage Current KEY on the 601PRO. 6) Press the print data key at any time to generate a printout of the latest measurement. Figure 2 patient leakage Current Note 1, In addition to Probes ,Patient leakage current test should be perform if ECG or PCG parts used; 2, If the current test standard being used does not include Patient Leakage DC readings, or the DC option is not enabled, then DC readings will not be available through the APPLIED PART SOFT KEY selections. Refer to Chapter 8, Standards and Principles. Failure Check any broken of the Applied parts. Replace any defective one. Check any broken of the ECG/PCG module if used, Replace any defective one. Check any broken of the Power Unit. Replace a new one if any portion defective. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. Inspect wiring for bad crimps, poor connections, or damage. If the leakage current measurement tests fail on a new unit and if situation cannot be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal. LIMITS A-10 Electrical Safety Inspection ELECTRICAL SAFETY INSPECTION 6- Patient Leakage Current All countries For BF ECG input and transducer 100μA Normal Condition 500μA Single Fault Condition Electrical Safety Inspection A-11 ELECTRICAL SAFETY INSPECTION 7- Mains on Applied Part Leakage OVERVIEW The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage, through a limiting resistance, to selected applied part terminals. Current measurements are then taken between the selected applied part and earth. Measurements are taken with the test voltage (110% of mains) to applied parts in the normal and reverse polarity conditions as indicated on the display. The following outlet conditions apply when performing the Mains on Applied Part test. Normal Polarity; Reversed Polarity TEST PROCEDURE Prepare To perform a calibration from the Mains on Applied Part test, press CAL (SOFT KEY 2). 1) 2) Disconnect ALL patient leads, test leads, and DUT outlet connections. Press CAL to begin calibration, as shown: If the calibration fails, the previously stored readings will be used until a passing calibration has occurred. Also, the esc/stop key has no effect during calibration. 3) When the calibration is finished, the Mains on Applied Part test will reappear. Warning 1) 2) A 2-beep-per-second signal indicates high voltage present at the applied part terminals while a calibration is being performed. High voltage is present at applied part terminals while measurements are being taken. Performance 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601 A-12 Electrical Safety Inspection ELECTRICAL SAFETY INSPECTION 7- Mains on Applied Part Leakage 2) 3) Attach the applied parts to the 601PRO applied part terminals. Press shortcut key 7. The Mains on Applied Part test is displayed. 4) Select the desired outlet configuration and applied part to test using the appropriate SOFT KEYS: Press START TEST (SOFT KEY 1) to begin the test. Press the print data key to generate a printout of the latest measurement. 5) 6) Figure 3 Mains on Applied part leakage Note 1, In addition to Probes ,Patient leakage current test should be perform if ECG or PCG parts used; 2, If all of the applied parts correspond to the instrument type, the applied parts will be tied together and one reading will be taken. If any of the applied parts differ from the instrument type, all applied parts will be tested individually, based on the type of applied part. This applies to Auto and Step modes only. Failure Check any broken of the Applied part. Replace any defective one. Check any broken of the ECG/PCG module if used, Replace any defective one. Check any broken of the Power Unit. Replace a new one if any portion defective. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other Electrical Safety Inspection A-13 ELECTRICAL SAFETY INSPECTION 7- Mains on Applied Part Leakage outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. Inspect wiring for bad crimps, poor connections, or damage. If the leakage current measurement tests fail on a new unit and if situation cannot be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal. LIMITS All countries: For BF ECG input and transducer: 5000μA A-14 Electrical Safety Inspection ELECTRICAL SAFETY INSPECTION 8- Patient Auxiliary Current overview Patient Auxiliary currents are measured between any selected ECG jack and the remaining selected ECG jacks. All measurements may have either a true RMS or a DC-only response. TEST PROCEDURE Prepare 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device. Attach the patient leads to the 601PRO ECG jacks. Define the Lead Types from the View Settings Option (refer to: Lead Type Definitions in Section 5 of this chapter). Press shortcut key 8. The Patient Auxiliary Current test is displayed, and the test begins immediately. Display values are continuously updated until another test is selected. 2) 3) 4) 5) 6) 7) 8) Press SOFT KEYS 1-4 to select leakage tests Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current: Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the 601PRO: Press the print data key at any time to generate a printout of the latest measurement. Figure 4 patient Auxiliary Current Electrical Safety Inspection A-15 ELECTRICAL SAFETY INSPECTION 8- Patient Auxiliary Current Note If the current test standard being used does not include Patient Auxiliary Current DC readings, or the DC option is not enabled, then DC readings will not be available through the APPLIED PART SOFT KEY selections. Failure Check any broken of the AC cable. Replace a new one if any portion defective. Check any broken of the enclosure. Replace any defective part. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. Inspect wiring for bad crimps, poor connections, or damage. If the leakage current measurement tests fail on a new unit and if situation cannot be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal. LIMITS All countries For BF ECG input and transducer 100μA Normal Condition 500μA Single Fault Condition A-16 Electrical Safety Inspection ELECTRICAL SAFETY INSPECTION FORM (Class I equipment) Overall assessment: □ Scheduled inspection Test item: 1, 2, 3 □ Unopened repair type Test item: 1, 2, 3 □ Opened repair type, not modify the power part including transformer or patient circuit board Opened repair type, modify the power part including transformer or patient circuit board Test item: 1, 2, 3, 4, 5 □ Test item: 1, 2, 3, 4, 5, 6, 7, 8 Location: Technician: Equipment: Control Number: Manufacturer: Model: SN: Measurement equipment /SN: Date of Calibration: Pass/Fail INSPECTION AND TESTING 1 Power Cord Plug 2 Device Enclosure and Accessories 3 Device Labeling 4 Protective Earth Resistance Normal condition(NC) 5 Max: NC: 300μA(refer to Leakage NC: 500μA(refer to Leakage Current 8 ____μA Max 0.2 Ω UL60601-1) * Patient 7 Ω Limit Earth Single Fault condition(SFC) 6 /NA ____μA IEC60601-1) * SFC: 1000μA Normal condition(NC) □BF___μA Max: Single Fault condition(SFC) □BF___μA NC:100μA, SFC: 500μA BF applied part: Max: Mains on Applied Part Leakage □BF___μA Patient Auxiliary Normal condition(NC) □BF___μA Max: Single Fault condition(SFC) □BF___μA NC:100μA, SFC: 500μA Leakage Current BF applied part: 5000μA BF applied part: Note: 4-protective grounding impedance testing is applicable for M9 + UMT-500Plus trolley and is not applicable for unaccompanied M9 system or M9 system with UMT-500 trolley (without power supply). The equipment which sell to America shall comply with the requirement of UL60601-1, others shall comply with the requirement of IEC60601-1. Name/ Signature: ____________________Date:_____________________________ Electrical Safety Inspection A-17 Appendix B Phantom Usage Illustration Note: as an option, the phantom usage is not required to perform the routine maintenance. It can be used to guarantee the quality of the test. Note: Best storage and working temperature for phantom: 10℃ to 35℃. The test performance may be affected if the temperature goes beyond the range. Lay the probe gently on the acoustic window in the use. In case of acoustic window and TM damage, do not press acoustic window. Do not let the phantom fall off or bump. Do not put the 2. phantom upside down except for the maintenance. Targets disposal- KS107BD WARNI NG: 1. Targets disposal- KS107BG Phantom Usage Illustration B-1 Appendix C Description of Self-test Test Items C.1.1 Z0101 Hard Disk Verify Test Top test items N/A Test content Traverse all hard disk files from Doppler installation directory, compare and verify the files with the archived hard disk data. Analysis to test failure If the system prompts “Failed to open the result file”, the verification file does not exist. If the system prompts “The failed CRC: current verification value (failed file path, correct verification value)”, the hard disk data is damaged. Suggestion to test failure Restore the hard disk data; replace the file from M9 directory in C local disk with the CRC_Result.txt from the restore package. C.1.2 Z0201 PC Module and DSP FPGA Interconnection Test Top test items N/A Test content Test whether PCIe communication between PC module and DSP FPGA works well. Analysis to test failure Check whether Windows device manager recognizes Ultrasound Backbone Device. If the drive is not installed properly, it cannot be recognized. The drive goes wrong if the test result appears Error. PC module and DSP FPGA has communication error if the test result is FAIL. Suggestion to test failure a) Restore the device if the drive is not recognized. b) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. c) It is recommended to replace CPU if the test result is FAIL. C.1.3 Z0202 DSP FPGA DDRIII Test Top test items PC Module and DSP FPGA Interconnection Test Test content Description of Self-test Test Items C-1 Perform read and write tests for entire space of four types of DDRs that DSP FPGA plugs in. The program displays the test results of DSP buffer DDR (transmitting DSP processing result data), SCAN buffer DDR (transmitting scan control frame), IQ buffer DDR (transmitting IQ data) and Gather buffer DDR (collecting data). Analysis to test failure The drive goes wrong if the test result appears Error. The connection error between FPGA and plug-in DDR occurs if the test result is FAIL. Suggestion to test failure a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace CPU if the test result is FAIL. C.1.4 Z0203 DSP FPGA and TRA Interconnection Test (Control Interface) Top test items PC Module and DSP FPGA Interconnection Test Test content Test whether the control bus communication between DSP FPGA and XCVER of TRA FPGA works well via reading the register. Analysis to test failure The drive goes wrong if the test result appears Error. The connection error between DSP FPGA and TRA FPGA occurs if the test result is FAIL. Suggestion to test failure a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to change CPU if the test result is FAIL. C.1.5 Z0204 TRA AFE SPI Interface Test Top test items DSP FPGA and TRA Interconnection Test (Control Interface) Test content Test whether the SPI control bus communication between TRA FPGA and AFE works well via reading the registering. Analysis to test failure The drive goes wrong if the test result appears Error. TRA FPGA and AFE’s SPI bus have communication error if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to change CPU if the test result is FAIL. C-2 Description of Self-test Test Items C.1.6 Z0205 TRA AFE Digital Interface Test Top test items TRA AFE SPI Interface Test Test content Enter system test mode, write the data to TRA AFE, input delay RAM, re-read the data from delay-channel memory and make the judgment to locate the channel and AFE clip. Analysis to test failure The drive goes wrong if the test result appears Error. AFE clip goes wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error, which indicates the logic error of DSP FPGA occurs. It is necessary to restore the device if Error re-appears. b) It is recommended to replace CPU if the test result is FAIL. C.1.7 Z0206 ATGC Function Test Top test items TRA AFE Digital Interface Test Test content Control a channel to transmit 2V waveform. Collect the waveform that AFE receives as setting ATGC to max, min and medium value. Judge whether the amplitude of waveform changes as ATGC increases according to the analysis on RMS value. Analysis to test failure The drive goes wrong if the test result appears Error. The circuit of ATGC gain adjustment goes wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to change CPU if the test result is FAIL. C.1.8 Z0207 TRA Transmission and Reception Function Test Top test items ATGC Function Test Test content Test the coherence of 64 channels (from 65th channel to 128th channel) in transmitting and receiving: one channel transmits 2V 1M PHV1 waveform each time, and analyzes whether the waveform belongs to PHV1, and compares the signal-to-noise ratio of the channel with others. Analysis to test failure The drive goes wrong if the test result appears Error. Description of Self-test Test Items C-3 The waveform that the channel transmits is incorrect if the information “Open circuit emit receive channel: XXX” appears. The transmission of the channel affects others’ if the information “Open circuit emit receive channel: XXX” appears. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to change CPU if the test result is FAIL. C.1.9 Z0208 DSP FPGA and EC ARM Interconnection Test Top test items PC Module and DSP FPGA Interconnection Test Test content Test whether UART communication between DSP FPGA and EC ARM works well. Send the data which is written on the register to serial port EC data, and then send the data of the register from serial port EC data to re-read it. Then, judge the coherence of the sending data. Analysis to test failure The drive goes wrong if the test result appears Error. UART interconnection between DSP FPGA and EC ARM goes wrong if the test fails. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to change CPU if the test result is FAIL. C.1.10 Z0209 DSP FPGA and SM ARM Interconnection Test Top test items PC Module and DSP FPGA Interconnection Test Test content Test whether UART communication between DSP FPGA and SM ARM works well. Send the order through SM serial port drive, and re-read the data via the serial port. Analysis to test failure The drive goes wrong if the test result appears Error. UART interconnection between DSP FPGA and SM ARM goes wrong if the test fails. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace CPU if the test result is FAIL. C-4 Description of Self-test Test Items C.1.11 Z0210 System Voltage Test Top test items DSP FPGA and SM ARM Interconnection Test Test content Read the voltage values of P2V5, N11V7, P3V3, P5V, P1V2 and P1V8 via SM serial port drive. Read the voltage values of AP5V6, AP6V6, N5V6, AP3V6, P12V, P1V5, AP2V, AP2V8, VBAT, P1V and P1V35 via ADT7462 drive. Judge whether they meet the requirements. Analysis to test failure The drive goes wrong if the test result appears Error. The voltage value does not meet the requirement if the test result appears FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace CPU if the test result is FAIL. c) It is recommended to replace with new button battery if VBAT voltage is FAIL. C.1.12 Z0211 System Temperature Test Top test items PC Module and DSP FPGA Interconnection Test Test content Read DC-DC module and AFE temperature value via ADT7462 drive and read four CPU temperature values via bottom drive. Judge whether they meet the requirements. Analysis to test failure The drive goes wrong if the test result appears Error. The temperature value does not meet the requirement if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to check the fan condition first and replace PC module or CPU if the test result is FAIL. C.1.13 Z0212 Fan Speed Test Top test items DSP FPGA and SM ARM Interconnection Test Test content Read rotational speed values of six monitoring fans via SM serial port drive, and judge whether they meet the requirements. From left to right, there lie fan 0 to fan 5 respectively. Analysis to test failure The drive goes wrong if the test result appears Error. The fan rotational speed does not meet the requirement if the test result is FAIL. Description of Self-test Test Items C-5 Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error, which indicates the error of SM serial port occurs. It is necessary to restore the device if Error re-appears. b) It is recommended to repair the fan, which does not meet the requirements of rotational speed, if the test result is FAIL. C.1.14 Z0213 Speaker Test Top test items N/A Test content Play the music by pressing the speaker from left or right side. Test whether audio clip, amplifier circuit or speaker function works well. The dialog box appears from either left or right side to inquire the audibility of the speaker. If it is inaudible, click [Retry] to re-play the track of the music. If it fails after many times play, click [No, I Can’t]. If it is audible, click [Yes, I Can]. Analysis to test failure The audio module or the speaker does not work well if the test result is FAIL. Suggestion to failure test It is recommended to check the speaker and wire material first, and audio module, and then replace CPU. C.1.15 Z0214 WIFI Function Test Top test items N/A Test content Judge whether the wireless network adapter exists, and then search for SSID list. Analysis to test failure The wireless network adaptor cannot be recognized if information “There is no wireless device” appears. WIFI hotspot cannot be found if information “WIFI Function test FAIL” appears. Suggestion to failure test a) Check whether the connection of wireless network adaptor is fixed well and wireless network adaptor is not forbidden if the information “There is no wireless device” appears. b) Check whether there is WIFI hotspot if the information “WIFI Function test FAIL” appears. If there is a hotspot, replace the wireless network adaptor. C-6 Description of Self-test Test Items C.1.16 Z0125 4D Overcurrent Protecting Status Test Top test item PC module and DSP FPGA communication test Test content Read 4D circuit overcurrent protecting status. Analysis to Test Failure “Not under overcurrent protection” prompting indicates that 4D circuit is normal. “Under overcurrent protection” prompting indicates that 4D circuit is abnormal with excessive current. Suggestion to Test Failure It is recommended to change main board if the test result is FAIL. C.1.17 Z0216 4D Drive Circuit Test Top test item 4D Overcurrent Protecting Status Test Test content Set 4 driving signals to be sine wave. AD collects signal and decide frequency and amplitude after amplification. Analysis to Test Failure The drive goes wrong if the test result appears Error. “XXX drive signal failure” indicates corresponding drive circuit malfunction. Suggestion to Test Failure a) Restart the device to perform the self test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to change main board if the test result is FAIL. C.1.18 Z0217 TEE Temperature Signal Test Top test item PC module and DSP FPGA communication test Test content Read TEE temperature value. If it is not 0 or FF, TEE temperature signal is normal. Analysis to Test Failure The drive goes wrong if the test result appears Error. If test result is FAIL, then TEE temperature signal collecting link has a malfunction. Suggestion to Test Failure a) Restart the device to perform the self test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to change main board if the test result is FAIL. C.1.19 Z0218 TEE Angle Signal Test Top test item PC module and DSP FPGA communication test Test content Description of Self-test Test Items C-7 Read TEE angle value. If it is not 0 or FF, TEE angle signal is normal. Analysis to Test Failure The drive goes wrong if the test result appears Error. If test result is FAIL, then TEE angle signal collecting link has a malfunction. Suggestion to Test Failure a) Restart the device to perform the self test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to change main board if the test result is FAIL. C.1.20 Z0301 DSP FPGA and TRB Interconnection Test (Control Interface) Top test items PC Module and DSP FPGA Interconnection Test Test content Test whether the XCVER control bus communication between DSP FPGA and TRB FPGA works well via reading the registering. Analysis to test failure The drive goes wrong if the test result appears Error. The connection error between DSP FPGA and TRB FPGA occurs if the test fails. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace TR64 board if the test result is FAIL. C.1.21 Z0302 TRB AFE SPI Interface Test Top test items DSP FPGA and TRB Interconnection Test (Control Interface) Test content Test whether the SPI control bus communication between TRA FPGA and AFE works well via reading the registering. Analysis to test failure The drive goes wrong if the test result appears Error. TRA FPGA and AFE’s SPI have communication error if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace TR64 board if the test result is FAIL. C-8 Description of Self-test Test Items C.1.22 Z0303 TRB AFE Digital Interface Test Top test items TRB AFE SPI Interface Test Test content Enter system test mode, write the data to TRB AFE, input delay RAM, re-read the data from delay-channel memory and make the judgment to locate the channel and AFE clip. Analysis to test failure The drive goes wrong if the test result appears Error. AFE clip goes wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace TR64 board if the test result is FAIL. C.1.23 Z0304 DSP FPGA and TRA&TRB Interconnection Test (Data Interface) Top test items a) DSP FPGA and TRA Interconnection Test (Control Interface) b) DSP FPGA and TRB Interconnection Test (Control Interface) Test content Test whether XCVER data bus between TRB FPGA of TR64 board and TRA FPGA works well. Test whether XCVER data bus between TRA FPGA on the main board and DSP FPGA works well. Analysis to test failure The drive goes wrong if the test result appears Error. XCVER data bus on the connection of TRB FPGA-TRA FPGA-DSP FPGA goes wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace TR64 board if the test result is FAIL. If the error still exists, it is recommended to replace CPU. C.1.24 Z0305 TRB Transmission and Reception Function Test Top test items ATGC Function Test Test content Test the coherence of 64 channels (from 1st channel to 64th channel) in transmitting and receiving: one channel transmits 2V 1M PHV1 waveform each time, and Description of Self-test Test Items C-9 analyzes whether the waveform belongs to PHV1, and compares the signal-to-noise ratio of the channel with others’. Analysis to test failure The drive goes wrong if the test result appears Error. The waveform that the channel transmits is incorrect if the information “Open circuit emit receive channel: XXX” appears. The transmission of the channel affects others’ if the information “Open circuit emit receive channel: XXX” appears. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace TR64 board if the test result is FAIL. C.1.25 Z0401 DSP FPGA and PHV ARM Interconnection Test Top test items PC Module and DSP FPGA Interconnection Test Test content Test whether UART communication between DSP FPGA and PHV ARM works well. Send the order through PHV serial port, and re-read the data via the port. Analysis to test failure The drive goes wrong if the test result appears Error. UART interconnection between DSP FPGA and SM ARM goes wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace PHV board if the test result is FAIL. C.1.26 Z0402 CW Mode Test Top test items DSP FPGA and PHV ARM Interconnection Test Test content Adjust the voltage of CW mode linearly, and set four voltage values. Read PHV1P and PHV1N voltage value via PHV serial port. Analysis to test failure The drive goes wrong if the test result appears Error. The voltage value of CW mode does not meet the requirement if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace PHV board if the test result is FAIL. C-10 Description of Self-test Test Items C.1.27 Z0403 PHV Mode Test Top test items DSP FPGA and PHV ARM Interconnection Test Test content Adjust PHV voltage linearly, and set five voltage values. Read PHV1P, PHV1N, PHV2P and PHV2N voltage value via PHV serial port. Analysis to test failure The drive goes wrong if the test result appears Error. The voltage value of PHV mode does not meet the requirement if the test result appears FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace PHV board if the test result is FAIL. C.1.28 Z0404 HV Test Top test items DSP FPGA and PHV ARM Interconnection Test Test content Read positive and negative high-voltage value via PHV serial port drive. Analysis to test failure The drive goes wrong if the test result appears Error. The positive and negative 100 V does not meet the requirement if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace PHV board if the test result is FAIL. C.1.29 Z0501 Light Sensor Auto Adjust Function Test Top test items PC Module and DSP Interconnection Test Test content Ensure the device be in non-dark room conditions when performing the self-test. Otherwise, the test will fail. Description of Self-test Test Items C-11 Put the hand over the light sensor which lies in the center of the screen for at least 5 seconds. If the screen becomes darker, it indicates it works well. Then, take the hand off the light sensor; the screen becomes brighter in 5 seconds, it indicates it works well. If the two operations work well, please click "Yes, I can", otherwise, click "No, I can't". See the figure below: Analysis to test failure The drive goes wrong if the test result appears Error. Light sensor goes wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) Check whether the connecting material of light sensor is fixed well, and then replace light sensor board if the test result is FAIL. C.1.30 Z0601 Keyboard USB Interconnection Test Top test items N/A Test content Test USB communication between control panel and main unit works well via reading internal USB disk drive. Analysis to test failure The drive goes wrong if the test result appears Error. Control panel and main unit have communication error if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace control panel if the test result is FAIL. C-12 Description of Self-test Test Items C.1.31 Z0602 Keyboard Key, Encoder, TGC, Trackball Test Top test items Keyboard USB Interconnection Test Test content It mainly tests whether the buttons, encoders, TGCs, trackball, backlight LEDs and indicating LEDs in the keyboard are normal, and reads board ID, keyboard FPGA and version of program as well. Test description The keyboard testing interface is shown as follows: As shown in the figure above, click [Start] to perform the keyboard test. The controls on the simulation keyboard correspond with those on the real keyboard assembly. As for the button, the button on the simulation keyboard blinks while pressing the button on real keyboard. If the button continues blinking, it is being tested. If the color of the button changes, it finishes the test. As for the trackball, the cursor moves as roll the trackball on the keyboard. Meanwhile, on the simulation keyboard blinks, which indicates that the system the icon receives data from the trackball and the trackball has been tested already. on the simulation keyboard corresponds The encoder rotation test: the icon to the encoder on the real keyboard. When the user rotates the encoder towards one direction, the corresponding green ball around the encoder on the simulation keyboard will rotate to the same direction. The encoder panel turns to white when pressing the encoder. Encoder button test: encoder panel turns to white when pressing the encoder. All orange controls indicate that all buttons have the corresponding orange indicators. Description of Self-test Test Items C-13 TGC test: 8 TGC sliders on the keyboard correspond to controls on the simulation keyboard. When sliding TGC sliders on the keyboard, the corresponding controls on the simulation keyboard move as well. Keyboard backlight test: when the simulation keyboard initializes, all dual-color lights highlight in green on the keyboard. When a key is tested, the dual-color backlight automatically becomes orange after being pressed. After all tests for the keyboard assembly are finished, the keyboard screen is shown below: After finishing the tests, if functions of the keyboard assembly are normal, click “Keyboard is OK”; otherwise, click “Keyboard is Bad”. Suggestion to failure test a) Replace the trackball if the trackball does not respond. b) Replace TGC board if TGC slider does not respond. c) Replace the keyboard if the keyboard does not respond. C.1.32 Z0603 Keyboard Key and Trackball LED Test Top test items Keyboard USB Interconnection Test Test content The system automatically adjusts the color of LED (white and orange) and the brightness of trackball. The user can identify the changes. Test description C-14 Description of Self-test Test Items The following dialog box appears when performing test. The system changes the brightness of LED (white and orange) and trackball respectively and check whether the brightness of LED on the keyboard changes accordingly. If LED brightness of the keyboard keeps identical as configured, click “LED and Traceball is OK” to quit the dialog box. If not, click “LED and Traceball is Bad” to quit the dialog box. Suggestion to failure test a) Replace the trackball if the trackball brightness does not respond. b) Replace the control panel if LED brightness does not respond. C.1.33 Z0701 LCD Monitor I2C Interconnection Test Top test items PC Module and DSP FPGA Interconnection Test Test content Read the display data from 12C bus, and judge whether it belongs to non 0 or non F, and then parse LCD model, panel sequence number and LCD version number. Analysis to test failure The drive goes wrong if the test result appears Error. The interconnection between DSP FPGA and LCD monitor goes wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) Check whether the connecting material between LCD monitor and main unit is fixed well, and then replace LCD EEPROM if the test result is FAIL. C.1.34 Z0702 LCD Monitor Adjust Data Check Test Top test items LCD Monitor I2C Interconnection Test Test content The logic judges the progress status of the monitor and judges whether FLASH data is consistent with the data on EEPROM via reading the register. Description of Self-test Test Items C-15 Analysis to test failure The drive goes wrong if the test result appears Error. FLASH data is inconsistent with that on EEPROM if the information “The data in the FLASH and EEPROM is inconsistent” appears. FLASH is empty if the information “There is no data in the FLASH”. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) Check whether the screen is calibrated, and then replace EEPROM or CPU board if the test result is FAIL. C.1.35 Z0703 LCD Monitor Brightness Control Test Top test items LCD Monitor I2C Interconnection Test Test content The dialog box appears when performing the test. The program controls the brightness of LCD via 12C bus. The brightness goes down to the lowest, and then goes up to the highest, then gets back to normal. If the brightness changes, click “Yes, I Can”, otherwise click “No, I Can’t”. If the user clicks “Retry” the system will repeat the procedure mentioned above. Analysis to test failure The drive goes wrong if the test result appears Error. Brightness control of LCD monitor goes wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace CPU if the test result is FAIL. C.1.36 Z0704 LCD Monitor Backlight Control Test Top test items PC Module and DSP FPGA Interconnection Test Test content The dialog box appears when performing the test. The program turns the backlight off for 3 seconds, and then goes back to normal. If backlight changes, click “Yes, I Can”, otherwise click “No, I Can’t”. If the user clicks “Retry” the system will repeat the procedure mentioned above. C-16 Description of Self-test Test Items Analysis to test failure The drive goes wrong if the test result appears Error. Backlight control of LCD monitor goes wrong if the test fails. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace CPU if the test result is FAIL. C.1.37 Z0801 Left Battery I2C Interconnection Test Top test items DSP FPGA and SM ARM Interconnection Test Test content Read the left battery status when it is on the site via SM serial port, and test whether 12C bus communication between left battery and SM ARM works well. Analysis to test failure The drive goes wrong if the test result appears Error. The left battery and SM ARM go wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace the left battery, and then replace CPU board if the test result is FAIL. C.1.38 Z0802 Right Battery I2C Interconnection Test Top test items DSP FPGA and SM ARM Interconnection Test Test content Read right battery status when it is on the site via SM serial port, and test whether 12C bus communication between right battery and SM ARM works well. Analysis to test failure The drive goes wrong if the test result appears Error. The right battery and SM ARM go wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. Description of Self-test Test Items C-17 b) It is recommended to replace the right battery, and then replace CPU if the test result is FAIL. C.1.39 Z0803 Left Battery Test Top test items Left Battery I2C Interconnection Test Test content Read the voltage, temperature, current, volume and charging times, etc, via SM serial port. Analysis to test failure The drive goes wrong if the test result appears Error. The left battery and SM ARM interconnection go wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace the left battery if the test result is FAIL. C.1.40 Z0804 Right Battery Test Top test items Right Battery I2C Interconnection Test Test content Read the voltage, temperature, current, volume and charging times, etc from the right battery, via SM serial port. Analysis to test failure The drive goes wrong if the test result appears Error. The right battery and SM ARM interconnection go wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace the right battery if the test result is FAIL. C.1.41 Z0901 ECG Module Information Read Test Top test items PC Module and DSP FPGA Interconnection Test Test content The program decides whether ECG is on the site, sends orders via ECG serial port, judges the returned data, and parses Bootloader version, board ID and software version. Analysis to test failure The drive goes wrong if the test result appears Error. ECG is not located or the located circuit goes wrong if the information “ECG Module is not on the site” appears. C-18 Description of Self-test Test Items The communication error between ECG board and main board goes wrong if the information “ECG Module information read test FAIL” appears. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace ECG board if the test result is FAIL. C.1.42 Z0902 ECG Module Self Test Top test items ECG Board Information Read Test Test content ECG sends self-test order when it is on the site via ECG serial port and analyzes the self-test result, and judges the status for A/D, Flash, DRAM, CPU, Watchdog, and Voltage 33 Analysis to test failure The drive goes wrong if the test result appears Error. ECG board goes wrong if the test result is FAIL. Suggestion to failure test a) Restart the device and perform the self-test if the test result appears Error. It is necessary to restore the device if Error re-appears. b) It is recommended to replace ECG board if the test result is FAIL. Description of Self-test Test Items C-19 P/N: 046-006006-00 (25.0)
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