M5 Diagnostic Ultrasound System Operators Manual Rev 1.0 April 2017

Table of Contents Table of Contents ... i Intellectual Property Statement ... I Responsibility on the Manufacturer Party... I Warranty ... II Exemptions ... II Customer Service Department ... III Important Information ... IV Introduction ... V

Safety Precautions ...VII 1

2

3

4

5

Overview ... 1-1 1.1

Intended Use ... 1-1

1.2

Contraindication... 1-1

1.3

Product and Model Code ... 1-1

Product Specifications ... 2-1 2.1

Imaging Modes ... 2-1

2.2

Power Supply (Adapter) ... 2-1

2.3

Environmental Conditions ... 2-1

2.4

External Dimensions and Weight ... 2-1

System Configuration ... 3-1 3.1

Standard Configuration ... 3-1

3.2

Probes and Needle-guided Brackets Available ... 3-1

3.3

Options ... 3-3

3.4

Peripherals Supported ... 3-4

System Introduction... 4-1 4.1

Introduction of Each Unit ... 4-1

4.2

Extend Modules ... 4-3 4.2.1

Probe Extend Module ... 4-3

4.2.2

IO Extend Module ... 4-4

4.2.3

V/A Extend Module ... 4-5

4.2.4

ECG Module ... 4-5

4.3

Control Panel ... 4-6

4.4

Symbols ... 4-9

Set-up & Connections ... 5-1 i

5.1

System Set-up ... 5-1

5.2

Power Supply ... 5-1

5.3

5.2.1

Connecting the External Power Supply ... 5-1

5.2.2

Powered by Batteries ... 5-1

Connecting / Disconnecting a Transducer ... 5-2 5.3.1

Connecting a Transducer ... 5-2

5.3.2

Disconnecting a Transducer ... 5-3

5.4

Connecting the Probe Extend Module ... 5-3

5.5

Connecting IO Extend Module ... 5-4

5.6

Connecting the V/A Extend Module... 5-4

5.7

Connecting the ECG Module... 5-4

5.8

Connecting the Footswitch ... 5-5

5.9

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

5.10 Installing a Graph / Text Printer ... 5-6 5.11 Installing a Video Printer... 5-7 5.12 Use of M-Pack ... 5-9 5.12.1 Introduction of M-Pack ... 5-9 5.12.2 Use of M-Pack ... 5-10

6

7

Power ON / OFF ... 6-1 6.1

Powering ON the System ... 6-1

6.2

Powering OFF the System ... 6-3

Basic Screen and Operation ... 7-1 7.1

Basic Screen ... 7-1 7.1.1

Information Area... 7-1

7.1.2

Image Parameter and Menu Area... 7-3

7.1.3

Image-in-Image Thumbnail ... 7-3

7.1.4

Image Area... 7-3

7.1.5

Thumbnail Area of Images Saved... 7-4

7.1.6

Body Mark Area ... 7-4

7.1.7

Area of Help Information and Cursor Icon ... 7-4

7.1.8

Soft Menu Area ... 7-4

7.1.9

System Status Area... 7-5

7.1.10 Measurement Result Window ... 7-5 7.2

8

Basic Operations of Screens ... 7-5

Exam Preparation ... 8-1 8.1

To Start an Exam ... 8-1

8.2

Patient Information ... 8-1 8.2.1

New Patient Information ... 8-1

ii

8.3

9

8.2.2

Retrieve Patient Information from iStation ... 8-5

8.2.3

Retrieve Patient Information from Worklist ... 8-6

Pause Exam & Continue Exam ... 8-8 8.3.1

Pause Exam... 8-8

8.3.2

Continue Exam ... 8-8

8.4

End Exam ... 8-8

8.5

Activate Exam... 8-9

8.6

Cancel an Exam ... 8-9

8.7

Anonymous Patient Exam ... 8-9

Exam Types... 9-1 9.1

Introduction of Exam Types ... 9-1

9.2

Selecting Transducer and Exam Type... 9-2

9.3

Setting Exam Types... 9-3 9.3.1

Exam Selection ... 9-3

9.3.2

Exam Configuration ... 9-4

9.3.3

User-defined Exam Types... 9-5

10 Image Modes... 10-1 10.1 Image Modes ... 10-1 10.2 Switching Between Image Modes ... 10-2 10.3 Image Adjustments ... 10-3 10.3.1 B Mode ... 10-3 10.3.2 M Mode ... 10-8 10.3.3 Color Mode ... 10-9 10.3.4 Power / DirPower Mode ... 10-12 10.3.5 PW/CW Doppler Mode ... 10-12 10.3.6 Image Magnification ... 10-16 10.3.7 iZoom (Full-screen Zooming)... 10-17 10.4 Image Parameter Preset ... 10-17

11 Special Imaging Modes... 11-1 11.1 Smart3D ... 11-1 11.1.1 Note before Use ... 11-1 11.1.2 Smart3D Presetting... 11-3 11.1.3 Enter/ Exit Smart3D ... 11-5 11.1.4 3D Image Capture... 11-5 11.1.5 Procedures... 11-7 11.1.6 3D Image Browsing ... 11-8 11.1.7 Reset ROI ... 11-17 11.1.8 3D Image Storage and Review ... 11-17

iii

11.2 iScape ... 11-17 11.2.1 Enter or Exit iScape ... 11-18 11.2.2 Capture Images ... 11-18 11.2.3 Review the iScape Panoramic Image ... 11-19 11.2.4 Image Review ... 11-20 11.2.5 Save and Open Images ... 11-20 11.3 Free Xros M Image Parameters ... 11-21

12 Cine Review ... 12-1 12.1 Entering / Exiting Cine Review ... 12-1 12.2 Cine Review in the B or C Mode ... 12-1 12.2.1 Manual Cine Review ... 12-1 12.2.2 Auto Cine Review ... 12-2 12.3 Cine Review in the M or D Mode... 12-2 12.4 Linked Cine Review ... 12-2 12.5 Setting Region of Auto Review ... 12-3 12.6 Saving Cine ... 12-4 12.7 Cine Setup ... 12-4 12.7.1 Setting Cine Length ... 12-4 12.7.2 Setting Cine Memory Split ... 12-4

13 Measurements ... 13-1 13.1 Basic Operations ... 13-1 13.1.1 Entering Measurement Status ... 13-1 13.1.2 Measurement Result and Help Information ... 13-1 13.2 General Measurements ... 13-2 13.2.1 General Measurements – 2D ... 13-2 13.2.2 General Measurements - M Mode ... 13-2 13.2.3 General Measurements - Doppler ... 13-3 13.3 Application Measurements ... 13-3

14 Comments (Annotations)... 14-1 14.1 Entering / Exiting Comments ... 14-1 14.2 Comment Menu ... 14-1 14.2.1 Comment Text Library Menu ... 14-1 14.2.2 Soft Menu for Comments ... 14-2 14.3 Adding Comments ... 14-3 14.3.1 Typing Comment Characters ... 14-3 14.3.2 Adding a Comment Text... 14-3 14.3.3 Adding an Arrow... 14-4 14.4 Moving Comments... 14-4

iv

14.5 Modifying (Editing) Comments ... 14-4 14.5.1 Modifying (Editing) Characters ... 14-4 14.5.2 Modifying (Editing) Arrows ... 14-5 14.6 Deleting Comments ... 14-5 14.6.1 Deleting Comment Characters, Texts or Arrows ... 14-5 14.6.2 Deleting a Recently-Added Character, Text or Arrow ... 14-5 14.6.3 Delete Word ... 14-5 14.6.4 Deleting all Comments (Characters, Texts or Arrows) ... 14-6 14.7 Comment Preset... 14-6 14.7.1 Font Size and Arrow Size ... 14-6 14.7.2 User-defined Comments ... 14-7

15 Body Marks (Pictograms) ... 15-1 15.1 Entering / Exiting Body Mark Mode ... 15-1 15.2 Categories of Body Marks ... 15-1 15.3 Soft Menu for Body Marks ... 15-1 15.4 Adding Body Marks ... 15-1 15.5 Moving Body Marks ... 15-2 15.6 Deleting Body Marks ... 15-3 15.7 Body Mark Preset ... 15-3

16 Patient Data Management ... 16-1 16.1 Patient Information Management ... 16-1 16.1.1 Enter Patient Information ... 16-1 16.1.2 Patient Information Setting ... 16-1 16.2 Image File Management ... 16-2 16.2.1 Memory Media ... 16-2 16.2.2 Image File Formats ... 16-2 16.2.3 Image Storage Preset ... 16-3 16.2.4 Saving Images to the System ... 16-4 16.2.5 Quickly Saving Images to USB Flash Drive ... 16-4 16.2.6 Quickly Saving Full Screen Image to the System... 16-5 16.2.7 Thumbnails ... 16-5 16.2.8 Image Review and Analysis ... 16-5 16.2.9 iVision... 16-7 16.2.10 Sending Image File ... 16-9 16.3 Report Management ... 16-10 16.4 Patient Data Management (iStation) ... 16-11 16.4.1 Viewing Patient Information ... 16-12 16.4.2 Searching a Patient ... 16-12

v

16.4.3 Patient Data Management ... 16-13 16.4.4 Examinations ... 16-14 16.5 Network Storage ... 16-14 16.5.1 Network Storage Setting ... 16-15 16.5.2 Network Storage ... 16-16 16.6 Print Task Management ... 16-16 16.7 Backing Up and Erasing Files through DVD Drive ... 16-17 16.8 Task manager ... 16-18 16.9 Reviewing the AVI Files ... 16-20 16.10 Admin ... 16-20 16.10.1 Access Setting ... 16-20 16.10.2 Setting Access Control ... 16-20 16.10.3 System Login ... 16-20 16.10.4 Add/ Delete a User... 16-21 16.10.5 Modify Password... 16-23

17 Parameter Setup ... 17-1 17.1 Entering / Exiting Setup ... 17-1 17.2 System Setup ... 17-2 17.3 Exam Mode Preset ... 17-4 17.4 Image Parameter Preset ... 17-5 17.5 Comment Preset... 17-5 17.6 Body Mark Preset ... 17-5 17.7 Measurement Preset ... 17-5 17.8 Soft-key and Menu Preset ... 17-5 17.9 Peripheral Setup ... 17-8 17.10 Network Preset ... 17-10 17.11 Manage Settings... 17-10 17.11.1 Exporting Setup Data ... 17-10 17.11.2 Importing Setup Data ... 17-11 17.12 Maintenance ... 17-11 17.13 System Information... 17-11

18 Probes and Biopsy ... 18-1 18.1 Probes ... 18-1 18.1.1 Name and Function of Each Part of the Probe ... 18-3 18.1.2 Orientation of the Ultrasound Image and the Probe Head ... 18-6 18.1.3 Procedures for Operating ... 18-7 18.1.4 Wearing the Probe Sheath ... 18-10 18.1.5 When the Immersion Method is used (for 6LB7s and 6LE7s) ... 18-11

vi

18.1.6 Probes Cleaning and Disinfection (or Sterilization) ... 18-15 18.1.7 Storage and Transportation ... 18-18 18.2 Biopsy Guide ... 18-19 18.2.1 Needle-guided Brackets... 18-21 18.2.2 Names of Parts ... 18-22 18.2.3 Needle-guided Bracket Inspection and Installation ... 18-35 18.2.4 Entering or Exiting Biopsy Menu... 18-44 18.2.5 Displaying Biopsy Guide Lines ... 18-44 18.2.6 Verifying the Biopsy Guide Line ... 18-44 18.2.7 Removing the Needle-guided Bracket ... 18-45 18.2.8 Clean and Sterilize the Needle-guided Bracket ... 18-49 18.2.9 Storage and Transportation ... 18-50 18.2.10 Disposal ... 18-50

19 ECG ... 19-1 19.1 ECG Connection... 19-1 19.2 Displaying ECG Signal ... 19-2 19.3 ECG Triggering ... 19-2 19.3.1 ECG Triggering ... 19-2 19.3.2 Triggering Mode ... 19-3 19.3.3 Real & Trigger ... 19-3 19.4 ECG Review ... 19-3 19.5 Exiting ECG ... 19-3 19.6 Setting ECG... 19-3

20 Image Recording ... 20-1 20.1 VCR (Video Cassette Recorder) ... 20-1 20.1.1 Setup ... 20-1 20.1.2 Record ... 20-1 20.1.3 Replay ... 20-2 20.2 DVR (Digital Video Recorder)... 20-3 20.2.1 Setup ... 20-3 20.2.2 Entering/Exiting DVR ... 20-4 20.2.3 Record ... 20-4 20.2.4 Data Management ... 20-5 20.2.5 Video Replay... 20-7 20.3 Non-programmable Record and Replay ... 20-9

21 Batteries ... 21-1 21.1 Overview... 21-1 21.2 Precautions... 21-1

vii

21.3 Installing and Removing the Batteries ... 21-2 21.4 Battery Status Indicator ... 21-3 21.5 Checking Battery Performance ... 21-3 21.6 Battery Disposal ... 21-4

22 System Maintenance ... 22-1 22.1 Daily Maintenance ... 22-1 22.1.1 Cleaning the System ... 22-1 22.1.2 Backup of the System Hard Disk ... 22-4 22.2 Maintenance Checks by Service Engineer ... 22-4 22.3 Consumables and Periodic Part Replacement ... 22-5 22.4 Troubleshooting ... 22-5

23 Acoustic Output ... 23-1 23.1 Concerns with Bioeffects ... 23-1 23.2 Prudent Use Statement ... 23-1 23.3 ALARA Principle (As Low As Reasonably Achievable) ... 23-2 23.4 MI/TI Explanation... 23-2 23.4.1 Basic Knowledge of MI and TI ... 23-2 23.4.2 MI/TI Display ... 23-3 23.5 Acoustic Power Setting ... 23-3 23.6 Acoustic Power Control ... 23-4 23.7 Acoustic Output ... 23-5 23.7.1 Derated Ultrasonic Output Parameters... 23-5 23.7.2 Limits of Acoustic Output ... 23-5 23.7.3 Differences between Actual and Displayed MI and TI ... 23-6 23.8 Measurement Uncertainty ... 23-6 23.9 References for Acoustic Power and Safety ... 23-6

24 Measurement Accuracy ... 24-1 25 Safety Classification ... 25-1 26 Guidance and Manufacturer's Declaration ... 26-1 Appendix A

Wireless LAN... A-1

Appendix B

DICOM ... B-1

Appendix C

Remote Control and Net Update ... C-1

Appendix D

Ultrasound System Software Restoring ... D-1

Appendix E

Electrical Safety Inspection ... E-1

viii

© 2010-2017 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is 2017-04.

The MindrayVNC ver. 1.0 contained in this product is revised by MINDRAY on Aug, 2009, based on the UltraVNC ver. 1.0.5.5, and it complies with GNU General Public License. SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. owns the intellectual property rights to the revised part. Please contact [email protected] for MindrayVNC ver. 1.0. This version of the manual applies to 06.03.00 software for the M5 ultrasound system.

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: z z z z

all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; the electrical installation of the relevant room complies with the applicable national and local requirements; and the product is used in accordance with the instructions for use. MindrayVNC ver. 1.0 is free open source software, the performance of MindrayVNC ver. 1.0 is not guaranteed by MINDRAY.

I

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

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

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

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

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

„

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

„

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

„

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

„

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

„

Others not caused by instrument or part itself.

II

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

Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430-0619 USA Tel: +1(201) 995-8000 Toll Free: +1 (800) 288-2121 Fax: +1 (800) 926-4275

III

Important Information 1.

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

2.

The warranty does not cover the following items, even during the warranty period: a. Damage or loss due to misuse or abuse. b.

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

c.

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

d. Damage or loss due to use of the system outside the region where the system was originally sold. e. Damage or loss involving the system purchased from a source other than Mindray or its authorized agents. 3.

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

4.

Do not make changes or modifications to the software or hardware of this system.

5.

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

6.

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

7.

Important data must be backed up on external memory media.

8.

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

9.

This manual contains warnings regarding foreseeable potential dangers, but you shall always be alert to dangers other than those indicated as well. Mindray shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions described in this operator’s manual.

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

IV

Introduction This operator’s manual describes the operating procedures for this diagnostic ultrasound system. To ensure safe and correct operations, carefully read and understand the manual before operating the system.

1． Notation Conventions In this operator’s manual, the following words are used besides the safety precautions (refer to "Safety Precautions"). Please read this operator’s manual before using the system. Indicates information of interest to users of this system as to exceptional conditions or operating procedures.

NOTE:

CAUTION:

1.

The diagnostic ultrasound system is not intended for ophthalmic use. Its use in this clinical specialty is contraindicated.

2.

United States federal law restricts this device to be sale by or on the order of a physician.

2． Operator’s Manuals You may receive multi-language manuals in compact disc or paper. Please refer to English manual for latest information and register 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 upon the software version, options and configuration of the system. 1) Manuals on Paper z

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.

z

Operator’s Manual [Advanced Volume] Describes measurement preset, measurements and calculations, etc.

z

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

z

Operation Note Contains quick guide for basic operations of the system.

NOTE:

1

The manuals in CD are the manuals translated into languages other than English according to English manuals.

2

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

3

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

V

3．Content of Operator’s Manual 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 upon the software version, options and configuration of the system.

VI

Safety Precautions 1. Meaning of Signal Words In this operator’s 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 understand their meaning 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.

2. Meaning of Safety Symbols Symbol

Description Type-BF applied part The ultrasound transducers connected to this system are Type-BF applied parts. The ECG module connected to this system is Type-BF applied part.

Caution.

VII

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

DANGER:

Do not use flammable gasses, such as anesthetic gas, oxygen or hydrogen, or flammable liquids such as ethanol, near this system or the probe, because there is danger of explosion.

WARNING:

1.

Connect the adapter 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. You must use the power adapter provided with the system; otherwise electric shock may result.

2.

Use the printing cable provided with this system to connect the printer. Electric shock may result.

3.

Connect the grounding conductor before turning ON the system. Disconnect the grounding cable after turning OFF the system. Otherwise, electric shock may result.

4.

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.

5.

Before cleaning the system, disconnect the power cord from the outlet. System failure and electric shock may result.

6.

This system is not water-proof. Do not use this system in any place where water leakage may occur. If any water is sprayed on or into the system, electric shock may result. If water is accidentally sprayed on or into the system, contact Mindray Customer Service Department or sales representative.

7.

Store and use the transducers carefully. Do not use a transducer that has a damaged, scratched surface, or exposed wiring of any kind. Immediately stop using the transducer and contact Mindray Customer Service Department or sales representative.

8.

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.

9.

Only use the transducers provided by Mindray. Otherwise, the system or the transducer may be damaged, causing a profound failure, e.g. a fire in the worst case.

VIII

10.

Do not subject the transducers to knocks or drops. Use of a defective transducer may cause an electric shock.

11.

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.

12.

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.

13.

Only use the ECG leads provided with the ECG module; otherwise electric shock may result.

14.

When moving the system, you should first fold the LCD display, disconnect the system from other devices (including transducers) and disconnect the system from the power supply.

15.

Accessory equipment connected to the analog and digital interfaces 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 IEC60601-1-1. 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 IEC60601-1-1. If you have any questions regarding these requirements, consult your sales representative.

16.

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.

17.

When using intra-cavity transducers, do not activate the transducer outside the patient’s body.

18.

The ultrasound system can be powered by connecting to mains power supply or powered by internal battery, if you have any doubt with stability of mains power protective grounding, please use internal battery.

19.

DO NOT touch the Signal I/O ports if in contact with the patient; otherwise patient injury may result.

IX

CAUTION:

1.

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.

2.

Malfunctions due to radio wave: z

z

3.

If a radio wave emitting device is used in the proximity of this system, it may interfere with operations. Do not bring or use devices that generate radio waves, such as cellular telephones, transceivers, and radio controlled toys, in the room where the system is installed. 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: 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. Object placed on the monitor may fall and injure an individual. Fasten and fully secure any peripheral device before moving the system. A loose peripheral device may fall and injure an individual.

4.

Do not expose the system to excessive vibration through transportation. Mechanical damage may result.

5.

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 overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped.

6.

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.

X

7.

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.

8.

There is no risk of high-temperature burns during routine 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. If a patient complains of any excessive heat from the transducer, immediately stop scanning. To prevent patient burns, ensure there is no surface damage to the transducer. 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.

9.

The system and its accessories are not disinfected or sterilized prior to delivery. The operator is responsible for the cleaning and disinfection of transducers 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 or gasses that are harmful to the human body or that may damage the accessory.

10.

It is necessary to press [End Exam] 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.

11.

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.

12.

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.

13.

If the system is powered off improperly during operation, it may result in data damage of the system’s hard disk or system failure.

14.

Do not use the system to examine a fetus in the Doppler mode for a long period of time.

15.

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.

16.

It is recommended to only use the video devices specified in this manual. XI