TE5 , TE7 , TE8 , TE9 , TE10 Series Operators Manual

©2021 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All Rights Reserved. For this Operator’s Manual, the issue date is 2021-03.

Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. , , , , , , BeneView, WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: •

all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;

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the electrical installation of the relevant room complies with the applicable national and local requirements; and

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

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

WARNING It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

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Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to: •

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

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

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

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Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.

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

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Others not caused by instrument or part itself.

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

EC-Representative:

Shanghai International Holding Corp. GmbH(Europe)

Address:

Eiffestraβe 80, Hamburg 20537, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

Important Information •

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

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

Damage or loss due to misuse or abuse.

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

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Damage or loss caused by failure to meet the specified conditions for this system, such as inadequate power supply, improper installation or environmental conditions.

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Damage or loss due to use of the system outside the region where the system was originally sold.

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Damage or loss involving the system purchased from a source other than Mindray or its authorized agents.

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

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

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In no event shall Mindray be liable for problems, damage, or loss caused by relocation, modification, or repair performed by personnel other than those designated by Mindray.

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The purpose of this system is to provide physicians with data for clinical diagnosis. The physician is responsible for the results of diagnostic procedures. Mindray shall not be liable for the results of diagnostic procedures.

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Important data must be backed up on external memory media.

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Mindray shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents.

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This manual contains warnings regarding foreseeable potential dangers, but you shall also be continuously alert to dangers other than those indicated. Mindray shall not be liable for damage or loss resulting from negligence or ignorance of the precautions and operating instructions described in this operator’s manual.

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If a new manager takes over this system, be sure to hand over this operator’s manual to the new manager.

About This Manual This operator’s manual describes the operating procedures for this diagnostic ultrasound system and the compatible probes. To ensure safe and correct operation, carefully read and understand the manual before operating the system.

Meaning of Signal Words In this manual, the signal words DANGER, WARNING, CAUTION, NOTE and TIP are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual. Signal word

Meaning

DANGER

Indicates an imminently hazardous situation that, if not avoided, will result in death or serious injury.

WARNING

Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury.

NOTE

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

TIP

Important information that helps you to use the system more effectively.

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Hardcopy Manuals •

Operator’s Manual [Basic Volume] Describes the basic functions and operations of the system, safety precautions, exam modes, imaging modes, preset, maintenance and acoustic output, etc.

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Operator’s Manual [Advanced Volume]

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Operator’s Manual [Acoustic Power Data and Surface Temperature Data] Contains data tables of acoustic output for transducers.

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Quick Reference Guide Contains a quick reference guide for basic system operations.

NOTE: •

Manuals on CD are the manuals translated into languages other than English, according to the English manuals.

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If you find that the contents of the manuals on CD are NOT consistent with the system or the English manuals, refer ONLY to the corresponding English manuals.

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The accompanying manuals may vary depending on the specific system you purchased. Please refer to the packing list.

Software Interfaces in this Manual Depending on the software version, preset settings and optional configuration, the actual interfaces may be different from those in this manual.

Conventions In this manual, the following conventions are used to describe the buttons on the control panel, items in the menus, buttons in the dialog boxes and some basic operations: •

[Items in menu or buttons in dialog box]: square brackets indicate items in menus, on the soft menu or buttons in dialog boxes.

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Tap [Items or Buttons]: tap the corresponding item on the screen.

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[Items in menu] > [Items in submenu]: select a submenu item following the path.

Operator’s Manuals You may receive multi-language manuals on compact disc or paper. Please refer to the English manual for the latest information and registration information. The content of the operator manual, such as screens, menus or descriptions, may be different from what you see in your system. The content varies depending on the software version, options and configuration of the system.

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Contents Intellectual Property Statement ... I Responsibility on the Manufacturer Party ... I Warranty ... II Exemptions ... II Customer Service Department ... II Important Information ... II About This Manual ... III Meaning of Signal Words ... III Hardcopy Manuals ... IV Software Interfaces in this Manual ... IV Conventions ... IV Operator’s Manuals ... IV

1 Important Information ...1 - 1 1.1 Safety Precautions ... 1 - 1 1.2 Latex Alert ... 1 - 7 1.3 Parts that can be used within patient environment ... 1 - 7

2 System Overview ...2 - 1 2.1 Intended Use ... 2 - 1 2.2 Contraindication ... 2 - 1 2.3 Safety Classifications ... 2 - 1 2.4 Product Specifications ... 2 - 2 2.4.1 Power supply ... 2 - 2 2.4.2 Environmental Conditions ... 2 - 2 2.4.3 Dimensions and Weight ... 2 - 2 2.5 Product Differences ... 2 - 2 2.6 System Configuration ... 2 - 4 2.6.1 Standard Configuration ... 2 - 4 2.6.2 Probes and Needle-guided Brackets Available ... 2 - 4 2.6.3 Options ... 2 - 8 2.6.4 Peripherals Supported ... 2 - 10 2.7 CIVCO Probe Sheath and Brackets ... 2 - 10 2.8 Introduction of Each Unit ... 2 - 11 2.9 ECG Module ... 2 - 13 2.10 Basic Operations ... 2 - 13 2.10.1 Screen Display ... 2 - 13 2.10.2 Control Panel ... 2 - 15 2.10.3 Select Exam Mode and Probe ... 2 - 16 2.10.4 Select the Imaging Mode ... 2 - 16 2.10.5 Imaging Adjustment ...2 - 17 2.10.6 Quickly Saving Image Settings ... 2 - 17 2.10.7 Annotations and Body Marks ...2 - 18 2.10.8 iVocal ...2 - 19 Operator’s Manual

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Contents

2.10.9 Splitting Display ... 2 - 21 2.10.10 Image Magnification ... 2 - 21 2.10.11 iZoom (Full Screen View) ... 2 - 22 2.10.12 Freeze/Unfreeze the Image. ... 2 - 22 2.10.13 Imaging Mode Switching When Frozen ... 2 - 23 2.11 Cine Review ... 2 - 23 2.11.1 Entering/Exiting Cine Review ... 2 - 23 2.11.2 Manual Cine Review ... 2 - 24 2.11.3 Auto Review ... 2 - 25 2.11.4 Linked Cine Review ... 2 - 25 2.12 Symbols and Warning Labels ... 2 - 25

3 System Preparation ... 3 - 1 3.1 Move/Position the System ... 3 - 1 3.2 Connecting the Power Cord ... 3 - 1 3.2.1 Connecting Power ... 3 - 1 3.2.2 Powered by Batteries ... 3 - 1 3.3 Power ON/OFF ... 3 - 2 3.3.1 Check before Powering ON ... 3 - 3 3.3.2 Power the System ON ... 3 - 3 3.3.3 Check the system after it is powered on ... 3 - 4 3.3.4 Power the System Off ... 3 - 5 3.3.5 Standby ... 3 - 5 3.4 Monitor Brightness/Contrast Adjustment ... 3 - 6 3.5 Display Position Adjustment ... 3 - 6 3.6 Connecting/Disconnecting a Probe ... 3 - 6 3.6.1 Connecting a Probe ... 3 - 7 3.6.2 Disconnecting a probe ... 3 - 8 3.7 Connecting USB Devices ... 3 - 8 3.8 Connecting the Footswitch ... 3 - 9 3.9 Installing a Printer ... 3 - 9 3.9.1 Connecting a Graph/Text Printer ... 3 - 9 3.9.2 Connecting a Video Printer ... 3 - 9

4 Setup ... 4 - 1 4.1 System Preset ... 4 - 1 4.1.1 Region ... 4 - 1 4.1.2 General ... 4 - 2 4.1.3 Image Preset ... 4 - 3 4.1.4 Measure ... 4 - 4 4.1.5 OB ... 4 - 5 4.1.6 Footswitch Function ... 4 - 5 4.1.7 Probe Function ... 4 - 5 4.1.8 Option ... 4 - 5 4.1.9 Access Control ... 4 - 6 4.1.10 Scan Code Preset ... 4 - 8 4.1.11 Peripheral Preset ... 4 - 11 4.1.12 Maintenance ... 4 - 11 4.1.13 iVision ... 4 - 12

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Contents

4.1.14 Security ... 4 - 13 4.1.15 System Information ... 4 - 14 4.2 Exam Related Preset ... 4 - 14 4.2.1 Exam Mode Preset ... 4 - 15 4.2.2 Measurement Preset ... 4 - 15 4.2.3 Body Mark/Comment Preset ... 4 - 16 4.2.4 iWorks Preset ... 4 - 17 4.3 Network Related Preset ... 4 - 18 4.3.1 DICOM Local Preset ... 4 - 18 4.3.2 DICOM Service Preset ... 4 - 19 4.3.3 eGateway Preset ... 4 - 25 4.3.4 Network Preset ... 4 - 26 4.3.5 Q-Path Preset ... 4 - 27

5 Exam Preparation ...5 - 1 5.1 Patient Information ... 5 - 1 5.1.1 New Patient Information ... 5 - 1 5.1.2 Retrieve Patient Information ... 5 - 2 5.2 Activate an Exam ... 5 - 2 5.3 End an Exam ... 5 - 2

6 Image Acquisition ...6 - 1 6.1 B Mode ... 6 - 1 6.1.1 B-mode Image Scanning ... 6 - 1 6.1.2 B-mode Image Parameters ... 6 - 1 6.2 Color Mode ... 6 - 4 6.2.1 Color Mode Image Scanning ... 6 - 4 6.2.2 Color Mode Image Parameters ... 6 - 4 6.3 Power Mode ... 6 - 6 6.3.1 Power Mode Image Scanning ... 6 - 6 6.3.2 Power Mode Image Parameters ... 6 - 6 6.4 M Mode ... 6 - 7 6.4.1 M Mode Image Scanning ... 6 - 7 6.4.2 M Mode Image Parameters ... 6 - 7 6.5 Color M Mode (CM) ... 6 - 8 6.5.1 CM Image Scanning ... 6 - 8 6.5.2 CM Image Parameters ... 6 - 8 6.6 Anatomical M Mode ... 6 - 8 6.6.1 Linear Anatomical M (Free Xros M) ... 6 - 9 6.6.2 Anatomical M Mode Parameters ... 6 - 9 6.7 PW/CW Mode ... 6 - 9 6.7.1 PW/CW Mode Image Scanning ... 6 - 9 6.7.2 PW/CW Mode Image Parameter ... 6 - 10 6.8 TDI ... 6 - 11 6.8.1 TDI Mode Image Scanning ... 6 - 12 6.8.2 TDI Mode Image Parameters ... 6 - 12 6.9 iScape View (Real-time Panoramic Imaging) ... 6 - 12 6.9.1 Basic Procedures for iScape Imaging ... 6 - 13 6.9.2 Image Review ... 6 - 14 Operator’s Manual

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Contents

6.9.3 Evaluate image quality ... 6 - 14 6.9.4 Cine Review ... 6 - 15 6.10 Smart B-line ... 6 - 15 6.10.1 Basic Procedures for Smart B-line ... 6 - 15 6.10.2 Overview ... 6 - 16 6.11 Smart VTI ... 6 - 17 6.12 Smart IVC ... 6 - 18 6.13 Contrast Imaging ... 6 - 19 6.13.1 Basic Procedures for Contrast Imaging ... 6 - 20 6.13.2 Left Ventricular Opacification ... 6 - 20 6.13.3 Image Parameters ... 6 - 21 6.13.4 Image Saving ... 6 - 22 6.13.5 Micro Flow Enhancement ... 6 - 22 6.13.6 Contrast Imaging QA ... 6 - 23 6.14 Auto GA ... 6 - 26 6.15 Smart FHR OB1 ... 6 - 26 6.16 iWorks (Auto Workflow Protocol) ... 6 - 27 6.16.1 Overview ... 6 - 27 6.16.2 Normal iWorks Basic Procedure ... 6 - 27 6.16.3 View Operation ... 6 - 28 6.16.4 Manual Examination ... 6 - 28 6.16.5 Insert ... 6 - 28

7 Smart 3D ... 7 - 1 7.1 Overview ... 7 - 1 7.1.1 Terms ... 7 - 1 7.1.2 ROI and VOI ... 7 - 2 7.1.3 Render Mode ... 7 - 2 7.1.4 MPR ... 7 - 3 7.2 Note before Use ... 7 - 4 7.3 Smart 3D Image Acquisition ... 7 - 6 7.4 Smart 3D Image Viewing ... 7 - 7 7.5 Image Saving ... 7 - 10

8 Physiological Unit Signal ... 8 - 1 8.1 ECG ... 8 - 1 8.2 ECG Review ... 8 - 3 8.2.1 Review Principle ... 8 - 3 8.2.2 Linked Review of Waveforms, M/D Images and 2D Images ... 8 - 3 8.3 Parameter Description ... 8 - 3

9 Measurement, Annotations and Body Mark ... 9 - 1 9.1 Measurement ... 9 - 1 9.2 Annotations ... 9 - 2 9.2.1 Adding Annotations ... 9 - 2 9.2.2 Moving Annotations ... 9 - 3 9.2.3 Modifying (Editing) Annotations ... 9 - 3 9.2.4 Deleting Annotations ... 9 - 4 9.3 Body Mark ... 9 - 4

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9.3.1 Adding Body Mark ... 9 - 4 9.3.2 Moving Body Marks ... 9 - 4 9.3.3 Deleting Body Marks ... 9 - 5 9.4 Voice Comments ... 9 - 5 9.4.1 Voice Comment Panel ... 9 - 5 9.4.2 Adding Voice Comments ... 9 - 5 9.4.3 Voice Comment Review ... 9 - 5

10 Patient Data Management ...10 - 1 10.1 Image File Management ... 10 - 1 10.1.1 Storage Media ... 10 - 1 10.1.2 Image File Formats ... 10 - 1 10.1.3 Image Storage Setting ... 10 - 2 10.1.4 Saving Full Screen Images to the System ... 10 - 2 10.1.5 Image Review and Analysis ... 10 - 2 10.1.6 Sending Image Files ... 10 - 3 10.2 Report Management ... 10 - 3 10.2.1 Report storage ... 10 - 3 10.2.2 Importing, exporting and sending a report ... 10 - 3 10.3 iStation - Patient Data Management ... 10 - 4 10.3.1 Searching a Patient ... 10 - 4 10.3.2 Patient Data View & Management ... 10 - 4 10.3.3 Image Compare ... 10 - 5 10.4 Recycle bin ... 10 - 5 10.5 iStorage ... 10 - 6 10.6 Print ... 10 - 6 10.6.1 Image Printing ... 10 - 6 10.6.2 Report Printing ... 10 - 7 10.7 Back up Files using the DVD Drive ... 10 - 7 10.8 Patient Task Management ... 10 - 7 10.9 V-Access ... 10 - 9 10.10 Q-Path ... 10 - 9

11 DICOM/HL7 ... 11 - 1 11.1 DICOM Storage ... 11 - 1 11.1.1 Send images on iStation/Review ... 11 - 1 11.1.2 To send images to storage after an exam ends ... 11 - 2 11.2 DICOM Print ... 11 - 2 11.2.1 Print images on iStation/Review ... 11 - 2 11.2.2 To send images to DICOM Print after an exam ends ... 11 - 2 11.2.3 To print images after saving image ... 11 - 2 11.3 Worklist ... 11 - 2 11.4 MPPS ... 11 - 3 11.5 Storage Commitment ... 11 - 3 11.5.1 After sending images on the iStation screen ... 11 - 3 11.5.2 Storage commitment after an exam ends ... 11 - 4 11.6 Query/Retrieve ... 11 - 4 11.7 DICOM Media Storage ... 11 - 4 11.7.1 Media Storage ... 11 - 4 Operator’s Manual

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Contents

11.7.2 Media review ... 11 - 5 11.7.3 Data Restore ... 11 - 5 11.8 Showcase Recording ... 11 - 5 11.9 Structured Report ... 11 - 5 11.9.1 Send structured reports for storage ... 11 - 6 11.9.2 Back up structured report ... 11 - 6

12 Probes and Biopsy ... 12 - 1 12.1 Probes ... 12 - 1 12.1.1 Laparoscopic Probe ... 12 - 4 12.1.2 Probe Functions by Part ... 12 - 6 12.1.3 Orientation of the Ultrasound Image and the Probe Head ... 12 - 7 12.1.4 Procedures for Operating ... 12 - 8 12.1.5 Wearing the Probe Sheath ... 12 - 10 12.1.6 Probes Cleaning and Disinfection/Sterilization ... 12 - 12 12.1.7 Cleaning the probe cable and connector ... 12 - 17 12.1.8 Probe Environmental Conditions ... 12 - 17 12.1.9 Storage and Transportation ... 12 - 19 12.2 Biopsy Guide ... 12 - 20 12.2.1 Needle-guided Brackets Available ... 12 - 22 12.2.2 Needle-Guided Bracket Inspection and Installation ... 12 - 22 12.2.3 Verifying the Biopsy Guide Line ... 12 - 53 12.2.4 Starting the biopsy procedure ... 12 - 54 12.2.5 Clean and Sterilize the Needle-Guided Bracket ... 12 - 55 12.2.6 Storage and Transportation ... 12 - 57 12.2.7 Disposal ... 12 - 57 12.3 Middle Line ... 12 - 57 12.4 eSpacial Navi ... 12 - 58 12.4.1 Interface ... 12 - 58 12.4.2 Preset ... 12 - 60 12.4.3 Preparation Before Needle Guidance ... 12 - 60 12.4.4 Procedure ... 12 - 61 12.4.5 Magnetizer Cleaning and Disinfection ... 12 - 61 12.4.6 Storage and Transportation ... 12 - 63 12.4.7 Disposal ... 12 - 63

13 DVR Recording ... 13 - 1 13.1 Start Recording ... 13 - 1 13.2 Sending Image ... 13 - 1 13.3 DVR Video Replaying ... 13 - 2 13.3.1 Replay on PC ... 13 - 2 13.3.2 Replay on the ultrasound system ... 13 - 2

14 System Maintenance ... 14 - 1 14.1 Daily Maintenance ... 14 - 1 14.1.1 Cleaning the System ... 14 - 1 14.1.2 Cleaning the peripherals ... 14 - 4 14.1.3 Disinfecting the Main Unit ... 14 - 4 14.1.4 Checking the Probe ... 14 - 8 14.1.5 Checking the Power Cable and Plug ... 14 - 8

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Contents

14.1.6 Checking Appearance ... 14 - 9 14.1.7 System Hard Drive Backup ... 14 - 9 14.2 Troubleshooting ... 14 - 9

A Barcode Reader ... A - 1 A.1 1-D Barcode Reader ... A - 1 A.1.1 Setting Up the Reader ... A - 2 A.1.2 Setting ... A - 2 A.1.3 Scanning in Hand-Held Mode ... A - 5 A.1.4 Scanning in Hands-Free Mode ... A - 6 A.2 2D Barcode Reader (Take DS4308 as an example) ... A - 8 A.2.1 Overview ... A - 8 A.2.2 Setting Up the Digital Imager Reader ... A - 9 A.2.3 Setting ... A - 9 A.2.4 Scanning in Hand-Held Mode ... A - 13 A.3 JADAK Barcode Reader ... A - 14 A.3.1 Supported Barcode Reader Model ... A - 14 A.3.2 Operating System Version ... A - 14 A.3.3 Setting Up the JADAK Barcode Reader ... A - 14 A.3.4 HS-1M JDK-2413 Configuration ... A - 14 A.3.5 HS-1R JDK-2601 Configuration ... A - 15 A.4 Maintenance ... A - 16

B Wireless LAN ... B - 1 B.1 Use the Wireless feature ...B - 2 B.2 IP Configure ...B - 2 B.3 EAP Network ...B - 2 B.4 Specifications ...B - 3 B.5 Troubleshooting ...B - 4

C Trolley and Accessories ... C - 1 C.1 Trolley (UMT-400/UMT-400Plus) ...C - 1 C.1.1 Trolley Accessories ...C - 1 C.1.2 Introduction of Each Unit (taking UMT-400 as an example) ...C - 2 C.1.3 Install Towelette Container ...C - 3 C.2 Table Stand ...C - 4 C.3 Wall Mount ...C - 4

D iScanHelper ... D - 1 D.1 Use iScanHelper for Reference ... D - 1 D.2 Use iScanHelper for Learning or Training ... D - 1 D.3 iScanhelper Menu ... D - 2 D.3.1 View Selecting Area ... D - 2 D.3.2 Help Information Area ... D - 2 D.3.3 Single/quad-window Display ... D - 3 D.4 Measurement, Comments, and Body Mark ... D - 3

E iVision ... E - 1 F List of Vocal Commands ... F - 1

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G EMC Guidance and Manufacturer’s Declaration ... G - 1 H Acoustic Output ... H - 1 H.1 Concerns with Bioeffects ... H - 1 H.2 Prudent Use Statement ... H - 1 H.3 ALARA Principle (As Low As Reasonably Achievable) ... H - 1 H.4 MI/TI Explanation ... H - 2 H.4.1 Basic Knowledge of MI and TI ... H - 2 H.4.2 MI/TI Display ... H - 3 H.5 Acoustic Power Setting ... H - 3 H.6 Acoustic Power Control ... H - 4 H.7 Acoustic Output ... H - 4 H.7.1 Derated Ultrasonic Output Parameters ... H - 4 H.7.2 Limits of Acoustic Output ... H - 5 H.7.3 Differences between Actual and Displayed MI and TI ... H - 5 H.8 Measurement Uncertainty ... H - 5 H.9 References for Acoustic Power and Safety ... H - 6

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1 1.1

Important Information Safety Precautions Please observe the following precautions to ensure patient and operator’s safety when using this system.

DANGER Do not operate this system and probes in an atmosphere containing flammable gases or liquids such as anesthetic gases, hydrogen, and ethanol, because there is danger of explosion.

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Operator’s Manual

Do not connect the three-wire cable of the system with a two-wire plug without protective grounding; otherwise, electric shock may result. Do connect the power plug of this system to wall receptacles that meet the ratings indicated on the rating nameplate. If adapters or multi-functional receptacles are used, it may cause the leakage current to exceed the safety requirement. In the environment that patient is 1.5 meters around, connect peripherals to the auxiliary power outlet, or power the peripherals by auxiliary output cable or isolation transformer complied with IEC60601-1 or the power input of the same safety level. DO NOT use power supply of different phases to power peripherals, like power supply of air-conditioning. 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 500 uA of IEC60601-1), and the responsibility is held by the user. Connect the grounding conductor before turning ON the system. Disconnect the grounding cable after turning OFF the system. Otherwise, electric shock may result. For the connection of power and grounding, follow the appropriate procedures described in this operator's manual. Otherwise, there is risk of electric shock. Do not connect the grounding cable to a gas pipe or water pipe; otherwise, improper grounding may result or a gas explosion may occur.

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Before cleaning the system, disconnect the power cord from the outlet. System failure and electric shock may result. This system is not water-proof designed. Do Not use this system in any place where water or any liquid leakage may occur. If any water is sprayed on or into the system, electric shock may result or the system may be damaged. If water is accidentally sprayed on or into the system, contact Mindray Customer Service Department or sales representative. DO NOT use a probe that has a damaged, scratched surface, or exposed wiring of any kind. Immediately stop using the probe and contact Mindray Customer Service Department or sales representative. There is risk of electric shock if using a damaged or scratched transducer. Do not allow the patient to contact the live parts of the ultrasound system or other devices, e.g. signal I/O ports. Electric shock may occur. The operator SHOULD NOT touch Signal Input Ports/Signal Output Ports and the patient at the same time. Do not use an aftermarket probe other than those specified by Mindray. The probes may damage the system causing a profound failure, e.g. a fire in the worst case. Do not subject the transducers to knocks or drops. Use of a defective transducer may cause an electric shock. Do not open the covers and front panel of the system. Short circuit or electric shock may result when the system hardware is exposed and powered on. Do not use the system with the patient when the system is being serviced or maintained. Do not use this system when any digital device such as a high-frequency electrotome, high-frequency therapeutic device or defibrillator is applied already. Otherwise, there is a risk of electric shock to the patient. Only use the ECG leads provided with the physiology module; otherwise, electric shock may be resulted. When moving the system, disconnect the system from other devices (including probes) and disconnect the system from the power supply. The auxiliary power output outlet in the system is used to supply power for the recommended peripheral devices. Do not connect other devices to the outlet, otherwise, the rated output power may be exceeded and failure may be resulted. Accessory equipment (analog or digital) connected to the ultrasound system must comply with the relevant IEC standards (e.g., IEC 60950 information technology equipment safety standard and IEC 60601-1 medical equipment standard). Furthermore, all configurations must comply with the standard IEC60601-1. It is the responsibility of the person, who connects additional equipment to the signal input or output ports and configures a medical system, to verify that the system complies with the requirements of IEC60601-1. If you have any questions regarding these requirements, consult your vendor. Operator’s Manual

1 Important Information

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Prolonged and repeated use of keyboards may result in hand or arm nerve disorders for some individuals. Observe the local safety or health regulations concerning the use of keyboards. When using intra-cavity transducers, do not activate the transducer outside the patient’s body. It is not allowed for the operator to have contact with other patients and the electronic parts (such as the input/output terminal of the signal) of other devices that are connected to the system. Otherwise, it may produce the electrical shock to the patient. DO NOT block the cooling vent of the system.

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Operator’s Manual

Precautions concerning clinical examination techniques: – This system must be used only by qualified medical professionals. – This operator’s manual does not describe clinical examination techniques. The clinician should select the proper examination techniques based on specialized training and clinical experience. Malfunctions due to radio wave: – If a radio wave emitting device is used in the proximity of this system, it may interfere with operations. Do not use or take any devices transmitting RF signals (such as cellular phones, transceivers and radio controlled products) in the room placing the system. – If a person brings a device that generates radio waves near the system, ask him/her to immediately turn OFF the device. Precautions concerning movement of the system: – If the circuit protector is tripped, it indicates that the system or a peripheral device was improperly shut down and the system is unstable. You cannot repair the system under this circumstance and must call the Mindray Customer Service Department or sales representative. There is no risk of high-temperature burns during normal ultrasound examinations. It is possible for the surface temperature of the transducer to exceed the body temperature of a patient due to environmental temperature and exam type combinations. Do not apply the transducer to the same region on the patient for a long time. Apply the transducer only for a period of time required for the purpose of diagnosis. Do not use the system to examine a fetus for a long period of time. Except accessories that have been stated as sterile, the system and its accessories are not disinfected or sterilized prior to delivery. The operator is responsible for the cleaning and disinfection of probes and sterilization of biopsy brackets according to the manuals, prior to the use. All items must be thoroughly processed to completely remove harmful residual chemicals,

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which will not only harmful to the human body, but also damage the accessory. It is necessary to end the current scan that is in progress and clear the current Patient Information field. Otherwise, new patient data may be combined with the previous patient data. Do not connect or disconnect the system’s power cord or its accessories (e.g., a printer or a recorder) without turning OFF the system power first. This may damage the system and its accessories or cause electric shock. If the system is powered off improperly during operation, it may result in data damage of the system’s hard disk or system failure. Do not use a USB memory device (e.g., a USB flash drive, removable hard disk) which has unsafe data. Otherwise, system damage may result. It is recommended to only use the video devices specified in this manual. Do not use gel, disinfectant, probes, probe sheath or needle-guided brackets that are not compatible with the system. The applied contrast agency should be compliant with the relevant local regulations. Read the Acoustic Output Principle in the operation manual carefully before operating this system on clinical examination. The cover contains natural rubber that can cause allergic reactions in some individuals. Please use the ultrasound gel compliant with the relevant local regulations. DO NOT expose the system to excessive vibration through transportation. Mechanical damage may result. Always keep the system dry. Avoid transporting this system quickly from a cold place to a warm place; otherwise condensation or water droplets may form allowing a short circuit and possible electric shock.

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DO NOT use the system in the vicinity of strong electromagnetic field (such as a transformer), which may affect the performance of the system.

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Do not use the system in the vicinity of high-frequency radiation source (e.g. cellular phones), which may affect the performance of the system or even lead to failure.

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When using or placing the system, keep the system horizontal to avoid imbalance.

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To avoid damaging the system, do not use it in following environment:

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Locations exposed to direct sunlight.

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Locations subject to sudden changes in environmental temperature.

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Dusty locations.

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Locations subject to vibration.

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Locations near heat generators.

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Locations with high humidity.

Turn ON the system only after the power has been turned OFF for a while. If the system is turned ON immediately after being turned OFF, the system may not be rebooted properly and could malfunction. Operator’s Manual

1 Important Information

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Use the Freeze key to freeze an image or turn off the power of the system before connecting or disconnecting a probe.

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Remove the ultrasound gel from the face of the transducer when the examination is completed. Water in the gel may enter the acoustic lens and adversely affect the performance and safety of the transducer.

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You should properly back up the system to a secure external storage media, including system configuration, settings and patient data. Data stored to the system’s hard drive may be lost due to system failure, improper operation or accident.

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Do not apply external force to the control panel. Otherwise, the system may be damaged.

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If the system is used in a small room, the room temperature may rise. Please provide proper ventilation and free air exchange.

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To dispose of the system or any part, contact Mindray Customer Service Department or sales representative. Mindray is not responsible for any system content or accessories that have been discarded improperly.

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Electrical and mechanical performance may be degraded due to long usage (such as current leakage or distortion and abrasion); the image sensitivity and precision may become worse too. To ensure optimal system operations, it is recommended that you maintain the system under a Mindray service agreement.

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Refer replacing job to Mindray service engineers or engineers authorized by Mindray only.

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Do not turn OFF the power supply of the system during printing, file storage or invoking other system operations. An interrupted process may not be completed, and can become lost or corrupted.

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Ensure that the current exam date and time are the same as the system date and time.

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Use detachable power supply cord as mains power breaking device. DO NOT set equipment in place where difficult for disconnection of detachable power supply cord.

Please read the following precautions carefully to ensure the safety of the patient and the operator when using the probes.

WARNING • • •

• • •

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Operator’s Manual

The ultrasound probe is only for use with the specified ultrasound diagnostic system. The ultrasound probe must be used only by qualified professionals. Confirm that the transducer and probe cable are normal before and after each examination. A defective probe may cause electric shock to the patient. Do not subject the probe to shock. A defective probe may cause electric shock to the patient. Do not disassemble the probe to avoid the possibility of electric shock. Never immerse the probe connector into liquids such as water or disinfectant because the connector is not waterproof. Immersion may cause electric shock or malfunction. A transducer sheath must be installed over the transducer before performing examination.

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1 Important Information

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When using a probe, pay attention to the status of the ultrasound image. Do not use the probe to perform image acquisition when the image is frozen.

CAUTION • •

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• • • •

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• •

When using the probe, wear sterile gloves to prevent infection. Please use the ultrasound gel com-pliant with the relevant local regulations. And manage the ultrasound gel properly to ensure that it does not become a source of infection. In normal diagnostic ultrasound mode, there is no danger of a normaltemperature burn; however, keeping the probe on the same region of the patient for a long time may cause such a burn. Do not use the carrying case for storing the transducer. If the carrying case is used for storage, it may become a source of infection. It is required to practice ALARA when operating ultrasound system. Minimize the acoustic power without compromising the quality of images. The probe and accessories supplied with it are not delivered disinfected or sterilized. Sterilization (or high-level disinfect) before use is required. Disposable components should be packaged sterile and for single-use only. Do not use if integrity of packaging violated or if expiration date has passed. Please use the disposable components compliant with the relevant local regulations. Please use the disinfection or sterilization solution recommended in this operator's manual; otherwise Mindray will not be liable for damage caused by other solutions. If you have any questions, please contact Mindray Customer Service Department or sales representative. Do not use pre-lubricated condoms as a sheath. Lubricant may not be compatible with the probe material and damage may result. The damage of the transducer may be caused by the contact of improper gel or cleaner: – DO NOT dip the transducer in the strong polar solution of ethanol, chloride of lime, ammonium chloride, acetone and formaldehyde. – DO NOT contact the transducer with solution or ultrasound gel containing oily medium such as mineral oil or lanoline.

NOTE: •

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Read the following precautions to prevent the probe from malfunction: –

Before connecting or disconnecting the probe, freeze or turn off the system.

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Clean and disinfect the probe before and after each examination.

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After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the ultrasound gel may solidify and the image quality would be degraded.

Operator’s Manual

1 Important Information

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Repeated disinfection will eventually damage the probe, please check the probe performance periodically.

Latex Alert When choosing a probe sheath, it is recommended that you directly contact CIVCO for obtaining information regarding probe sheaths, pricing, samples and local distribution. For CIVCO information, please contact the following: CIVCO Medical Instruments Tel: 1-800-445-6741 www.civco.com

WARNING Allergic reactions in patients sensitive to latex (natural rubber) may range from mild skin reactions (irritation) to fatal anaphylactic shock, and may include difficulty breathing (wheezing), dizziness, shock, swelling of the face, hives, sneezing, or itching of the eyes (FDA Medical Alert on latex products, “Allergic Reactions to Latex-containing Medical Devices”, issued on March 29, 1991). NOTE:

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The following definition of the WEEE label applies to EU member states only: The use of this symbol indicates that this system should not be treated as household waste. By ensuring that this system is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this system, please consult the distributor from whom you purchased the system.

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For system products, this label may be attached to the main unit only.

Parts that can be used within patient environment •

The ultrasound system

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Video Printers

Operator’s Manual

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