M6-Series -M6,M6T, M6 Exp,M6 Pro,M55,M58,M5 Exp Diagnostic Ultrasound System [Basic Volume] Operators Manual Rev 2.0 May 2021

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

1

2

Safety Precautions ... 1-1 1.1

Safety Classification ... 1-1

1.2

Meaning of Signal Words ... 1-2

1.3

Meaning of Safety Symbols ... 1-2

1.4

Safety Precautions ... 1-3

1.5

Latex Alert ... 1-11

1.6

Warning Labels ... 1-11

System Overview ... 2-1 2.1

Intended Use ... 2-1

2.2

Contraindication ... 2-1

2.3

Product and Model Code ... 2-1

Product Differences ... 2-1 2.4

2.5

Product Specifications ... 2-2 2.4.1

Imaging Modes ... 2-2

2.4.2

Power supply ... 2-2

2.4.3

Environmental Conditions ... 2-3

2.4.4

External Dimensions and Weight ... 2-3

System Configuration ... 2-3 2.5.1

Standard Configuration ... 2-3

2.5.2

Options ... 2-4

2.6

Introduction of Each Unit ... 2-9

2.7

Mobile trolley ... 2-10

2.8

Extend Modules... 2-14

i

2.9

2.8.1

Probe Extend Module ... 2-14

2.8.2

I/O extend module ... 2-15

2.8.3

V/A Extend Module ... 2-16

2.8.4

ECG module ... 2-17

Control Panel... 2-18

2.10 Symbols ... 2-22

3

System Preparation ... 3-1 3.1

Move/Posit the System ... 3-1

3.2

Power Supply ... 3-1

3.3

3.4

4

3.2.1

Connecting the External Power Supply ... 3-1

3.2.2

Powered by Batteries ... 3-2

Power ON /OFF... 3-2 3.3.1

Powering ON the System ... 3-2

3.3.2

Powering OFF the System ... 3-4

3.3.3

Standby ... 3-5

Connecting /Disconnecting a Probe ... 3-6 3.4.1

Connecting a Probe ... 3-6

3.4.2

Disconnecting a Probe ... 3-6

3.5

Connecting the Footswitch ... 3-7

3.6

Connecting/ Removing a USB Memory Device ... 3-7

3.7

Graph /Text printer... 3-8

3.8

Video Printer ... 3-9

3.9

Basic Screen and Operation ... 3-11 3.9.1

Basic Screen... 3-11

3.9.2

Basic Operations of Screens ... 3-16

Exam Preparation ... 4-1 4.1

To Start an Exam ... 4-1

4.2

Patient Information ... 4-1

4.3

4.2.1

New Patient Information ... 4-2

4.2.2

Retrieve Patient Information ... 4-6

Select an Exam Mode and Probe. ... 4-8 4.3.1

Supported Exam Modes ... 4-8

4.3.2

Selecting Exam Modes and Probes ... 4-8

4.4

Select the Imaging Mode ... 4-10

4.5

Activate & Continue an Exam ... 4-10

4.6

4.5.1

Activate an Exam ... 4-10

4.5.2

Continue an Exam ... 4-10

Pause Exam and End Exam ... 4-10 4.6.1

ii

Pause an Exam ... 4-10

4.6.2

5

End an Exam ... 4-11

4.7

Cancel an Exam ... 4-11

4.8

Anonymous Patient Exam ... 4-12

Image Optimization... 5-1 5.1

Switching Between Imaging Modes ... 5-1

5.2

Image Adjustment... 5-2

5.3

B Mode Image Optimization ... 5-4

5.4

5.5

5.6

5.7

5.8

5.9

5.3.1

B Mode Exam Protocol ... 5-4

5.3.2

B Mode Parameters ... 5-4

5.3.3

B Mode Image Optimization ... 5-4

M Mode Image Optimization ... 5-11 5.4.1

M Mode Exam Protocol ... 5-11

5.4.2

M Mode Parameters ... 5-11

5.4.3

M Mode Image Optimization... 5-12

Color Mode Image Optimization... 5-15 5.5.1

Color Mode Exam Protocol... 5-15

5.5.2

Color Mode Image Optimization ... 5-15

5.5.3

Color Mode Image Optimization ... 5-16

Power Mode Image Optimization ... 5-21 5.6.1

Power Mode Exam Protocol ... 5-21

5.6.2

Power Mode Image Parameters ... 5-21

5.6.3

Power Mode Image Optimization ... 5-22

PW/CW Doppler Mode Optimization ... 5-23 5.7.1

PW / CW Mode Exam Protocol ... 5-23

5.7.2

PW/CW Mode Image Parameters ... 5-23

5.7.3

PW/CW Doppler Mode Optimization ... 5-24

Anatomical M Mode... 5-30 5.8.1

Free Xros M Mode ... 5-30

5.8.2

Free Xros CM (Curved Anatomical M Mode) ... 5-32

TDI ... 5-33 5.9.1

TDI Exam Protocol... 5-33

5.9.2

TDI Image Parameters ... 5-34

5.9.3

TDI Image Optimization ... 5-35

5.9.4

TDI Quantitative Analysis (QA) ... 5-35

5.10 Color M Mode ... 5-39 5.10.1 Enter Color M Mode... 5-39 5.10.2 Exit Color M Mode ... 5-39 5.10.3 Image Parameters ... 5-39 5.11 3D/4D ... 5-41

iii

5.11.1 Note before Use... 5-41 5.11.2 Overview ... 5-42 5.11.3 3D/4D Preset ... 5-47 5.11.4 Smart 3D... 5-49 5.11.5 4D ... 5-61 5.11.6 Static 3D ... 5-63 5.12 iScape ... 5-65 5.12.1 Basic Procedures for iScape Imaging ... 5-65 5.12.2 iScape Preset ... 5-66 5.12.3 Image Acquisition... 5-66 5.12.4 iScape Viewing ... 5-67 5.12.5 Cine Review... 5-68 5.12.6 Save Image... 5-69 5.13 Stress Echo ... 5-70 5.13.1 About the Stress Echo Feature... 5-70 5.13.2 Acquisition of Stress Echo Loops ... 5-70 5.13.3 Navigation Toolbar ... 5-72 5.13.4 Selecting Preferred Stress Echo Loops (Select Mode) ... 5-74 5.13.5 Review Mode ... 5-75 5.13.6 Wall Motion Scoring and Reports ... 5-78 5.13.7 Maintenance and Protocol ... 5-80 5.13.8 Saving Stress Echo Data ... 5-83 5.13.9 Exiting the Stress Echo Feature ... 5-84 5.13.10 Measurement ... 5-84 5.14 Contrast Imaging ... 5-85 5.14.1 Basic Procedures for Contrast Imaging ... 5-85 5.14.2 Contrast Image Parameters ... 5-86 5.14.3 Measurement, Comments and Body Marks ... 5-87 5.15 Elastography ... 5-88 5.15.1 Basic Procedure for Elastography ... 5-88 5.15.2 Pressure Hint Curve ... 5-88 5.15.3 Mass Measurement ... 5-89 5.15.4 Cine Review... 5-89 5.16 Image Preset ... 5-90 5.16.1 Image Preset ... 5-90 5.16.2 Soft Menu and Menu Preset ... 5-92

6

Display & Cine Review ... 6-1 6.1

Image Display... 6-1 6.1.1

iv

Splitting Display ... 6-1

6.2

6.3

6.1.2

Image Magnification ... 6-1

6.1.3

Spot ... 6-1

6.1.4

Pan ... 6-2

6.1.5

iZoom (Full-screen Zooming) ... 6-2

6.1.6

Freeze/ Unfreeze the Image ... 6-2

Cine Review ... 6-3 6.2.1

Entering/ Exiting Cine Review ... 6-4

6.2.2

Cine Review in 2D Mode ... 6-4

6.2.3

Cine Review in M or D Mode ... 6-5

6.2.4

Linked Cine Review ... 6-6

6.2.5

Review Play ... 6-6

Image Compare... 6-6 6.3.1

Cine Compare ... 6-6

6.3.2

Frame Compare... 6-7

6.4

Cine Saving ... 6-7

6.5

Live Capture ... 6-7

6.6

Cine Memory ... 6-8 6.6.1

6.7

7

8

9

Cine Memory Setting ... 6-8

Cine Settings ... 6-8

ECG ... 7-1 7.1

ECG Operation Basic Procedures ... 7-2

7.2

ECG Setting ... 7-2

7.3

Parameter Description ... 7-3

7.4

ECG Review ... 7-4

Measurement... 8-1 8.1

Basic Operations ... 8-1

8.2

General Measurements ... 8-2 8.2.1

2D General Measurements ... 8-2

8.2.2

M General Measurements ... 8-3

8.2.3

Doppler General Measurements ... 8-3

8.3

Application Measurement ... 8-4

8.4

Measurement Accuracy ... 8-5

Comments and Body Marks ... 9-1 9.1

Comments (Annotations)... 9-1 9.1.1

To Add Comments ... 9-1

9.1.2

Comment Menu ... 9-1

9.1.3

Adding Comments ... 9-2

9.1.4

Moving Comments ... 9-4

v

9.2

9.1.5

Modifying (Editing) Comments ... 9-4

9.1.6

Deleting Comments ... 9-4

Body Marks (Pictograms) ... 9-5 9.2.1

Soft Menu for Body Marks ... 9-5

9.2.2

Adding Body Marks... 9-5

9.2.3

Moving Body Marks ... 9-6

9.2.4

Deleting Body Marks... 9-6

10 Patient Data Management ... 10-1 10.1 Patient Information Management ... 10-1 10.1.1 Enter Patient Information ... 10-1 10.1.2 Patient Information Setting ... 10-1 10.2 Image File Management ... 10-2 10.2.1 Memory Media ... 10-2 10.2.2 Image File Formats ... 10-2 10.2.3 Image Storage Preset ... 10-2 10.2.4 Saving Images to the System ... 10-3 10.2.5 Quickly Saving Images to USB Flash Drive ... 10-4 10.2.6 Quickly Saving Full Screen Image to the System ... 10-4 10.2.7 Thumbnails ... 10-4 10.2.8 Image Review and Analysis... 10-5 10.2.9 iVision ... 10-7 10.2.10 Sending Image File ... 10-8 10.3 Report Management... 10-9 10.4 Patient Data Management (iStation) ... 10-10 10.4.1 Viewing Patient Information ... 10-11 10.4.2 Searching a Patient ... 10-12 10.4.3 Patient Data Management ... 10-12 10.4.4 Examinations ... 10-13 10.5 Network Storage ... 10-13 10.6 Print Job Management ... 10-14 10.7 Backing Up and Erasing Files through DVD Drive... 10-14 10.8 Patient Task Management ... 10-16 10.9 Administration... 10-17 10.9.1 Access Setting ... 10-17 10.9.2 Setting Access Control ... 10-17 10.9.3 System Login ... 10-17 10.9.4 Add/ Delete a User ... 10-18 10.9.5 Modify Password ... 10-20

11 DICOM ...11-1

vi

11.1 DICOM Preset ... 11-1 11.1.1 Local TCP/IP Setting ... 11-1 11.1.2 DICOM Local Setting ... 11-3 11.1.3 DICOM Server Setting ... 11-4 11.1.4 DICOM Service Setting ... 11-5 11.2 Verify Connectivity ... 11-16 11.3 DICOM Service ... 11-16 11.3.1 DICOM Storage ... 11-16 11.3.2 DICOM Print ... 11-18 11.3.3 DICOM Worklist ... 11-19 11.3.4 MPPS ... 11-20 11.3.5 Storage Commitment ... 11-20 11.3.6 Query/ Retrieve... 11-21 11.4 DICOM Media Storage ... 11-22 11.5 Structured Report (SR) ... 11-24 11.6 Showcase Recording ... 11-24 11.7 DICOM Task Management ... 11-24

12 Probes and Biopsy ... 12-1 12.1 Probe ... 12-1 12.1.1 Name and Function of Each Part of the Probe... 12-4 12.1.2 Orientation of the Ultrasound Image and the Probe Head ... 12-5 12.1.3 Procedures for Operating ... 12-6 12.1.4 Wearing the Probe Sheath ... 12-8 12.1.5 Probe Cleaning, Disinfection and Sterilization... 12-10 12.1.6 Probe Environmental Conditions ... 12-15 12.1.7 Storage and Transportation ... 12-18 12.2 Biopsy Guide ... 12-19 12.2.1 Basic Procedures for Biopsy Guiding ... 12-21 12.2.2 Needle-guided Brackets ... 12-22 12.2.3 Biopsy Preset... 12-30 12.2.4 Needle-guided Bracket Inspection and Installation ... 12-31 12.2.5 Biopsy Menu ... 12-37 12.2.6 iNeedle ... 12-39 12.2.7 Verifying the Biopsy Guide Line... 12-41 12.2.8 Removing the Needle-guided Bracket ... 12-42 12.2.9 Clean and Sterilize the Needle-guided Bracket ... 12-45 12.2.10 Storage and Transportation ... 12-47 12.2.11 Disposal ... 12-47 12.3 Middle Line ... 12-48

vii

13 Recording ... 13-1 13.1 DVR ... 13-1 13.1.1 DVR Recording ... 13-1 13.1.2 DVR Video Replay ... 13-1

14 Setup ... 14-1 14.1 System Preset ... 14-2 14.1.1 Region ... 14-3 14.1.2 General ... 14-3 14.1.3 Image Preset ... 14-5 14.1.4 Meas ... 14-5 14.1.5 OB ... 14-5 14.1.6 Comment ... 14-5 14.1.7 Key Config ... 14-6 14.1.8 Biopsy ... 14-9 14.1.9 Option ... 14-10 14.1.10 Admin ... 14-10 14.2 Exam Preset ... 14-10 14.2.1 Exam Selection ... 14-11 14.2.2 Exam Configuration ... 14-11 14.2.3 User-defined Exam Modes ... 14-12 14.3 Image Preset ... 14-13 14.4 Measure Preset ... 14-14 14.5 Body Mark Preset ... 14-14 14.5.1 Preset Body Mark for Exam Mode... 14-14 14.5.2 User-defined Body Marks ... 14-15 14.5.3 Body Mark Softkey Preset ... 14-17 14.6 Comment Preset ... 14-18 14.6.1 Custom Comments ... 14-18 14.6.2 Comment Softkey Preset ... 14-19 14.7 Peripheral Preset... 14-19 14.8 Network Preset ... 14-20 14.9 Manage Settings ... 14-21 14.9.1 Exporting Setup Data... 14-21 14.9.2 Importing Setup Data ... 14-22 14.10 Maintenance ... 14-22 14.11 System Information ... 14-22

15 Batteries ... 15-1 15.1 Overview ... 15-1 15.2 Precautions ... 15-2

viii

15.3 Installing and Removing the Batteries... 15-2 15.4 Battery Status Indicator ... 15-3 15.5 One Full Discharge /Charge Cycle... 15-3 15.6 Checking Battery Performance ... 15-4 15.7 Battery Disposal ... 15-4

16 Acoustic Output ... 16-1 16.1 Concerns with Bioeffects ... 16-1 16.2 Prudent Use Statement ... 16-1 16.3 ALARA Principle (As Low As Reasonably Achievable) ... 16-1 16.4 MI/TI Explanation ... 16-2 16.4.1 Basic Knowledge of MI and TI ... 16-2 16.4.2 MI/TI Display ... 16-3 16.5 Acoustic Power Setting ... 16-3 16.6 Acoustic Power Control ... 16-4 16.7 Acoustic Output ... 16-5 16.7.1 Derated Ultrasonic Output Parameters ... 16-5 16.7.2 Limits of Acoustic Output ... 16-5 16.7.3 Differences between Actual and Displayed MI and TI ... 16-5 16.8 Measurement Uncertainty ... 16-6 16.9 References for Acoustic Power and Safety ... 16-6

17 EMC Guidance and Manufacturer’s Declaration ... 17-1 18 System Maintenance ... 18-1 18.1 Daily Maintenance ... 18-1 18.1.1 Cleaning the System ... 18-1 18.1.2 Checking the Probe ... 18-5 18.1.3 Checking the Power Cable and Plug ... 18-5 18.1.4 Checking Appearance ... 18-5 18.1.5 Backup of the System Hard Drive ... 18-5 18.2 Troubleshooting ... 18-5

Appendix A

Wireless LAN ... A-1

Appendix B

To Use the Lock ... B-1

Appendix C

Barcode Reader... C-1

Appendix D

iScanHelper ... D-1

Appendix E

Electrical Safety Inspection ... E-1

ix

©2020 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

All Rights Reserved.

For this Operator’s Manual, the issue date is 2020-06.

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.

, and 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. This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents: http://www.mindrayna.com/patents.

I

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; 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.

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

Manufacturer:

Mindray DS USA, Inc.

Address:

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: (1) Damage or loss due to misuse or abuse. (2) Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc. (3) Damage or loss caused by failure to meet the specified conditions for this system, such as inadequate power supply, improper installation or environmental conditions. (4) Damage or loss due to use of the system outside the region where the system was originally sold. (5) 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.

About This Manual This operator’s manual describes the operating procedures for this diagnostic ultrasound system M6/M6T/M6 Exp/M6s/M6 Pro/M55/M58/M5 Exp and the compatible probes. To ensure safe and correct operations, carefully read and understand the manual before operating the system.

IV

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.

CAUTION:

The diagnostic ultrasound system is not intended for ophthalmic use. Its use in this clinical specialty is contraindicated. U.S.A. Federal Law restricts this device to sale by or on the order of a physician.

Operator’s Manuals Please read the operator’s manuals carefully before operating the system. 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.

Hardcopy Manuals 

  

NOTE:

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. Operator’s Manual [Advanced Volume]: Describes measurement preset, measurements and calculations, etc. Operator’s Manual [Acoustic Power Data and Surface Temperature Data]: Contains data tables of acoustic output for transducers. Operation Note: Contains quick guide for basic operations of the system. 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.

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.

V

Conventions In this manual, these conventions are used to describe the buttons on the control panel, the items in menu, buttons in dialog box and some basic operations:     

VI

<Buttons>: The angular bracket indicates buttons, knobs and other controls on control panel. [Items in menu and buttons in dialog box]: The square bracket indicates items in menu or the soft menu, or buttons in dialog box. Click [Items or Button]: Move the cursor to the item or button and press <Set>, or click it on the soft menu. [Items in Menu][Items in Submenu]: Selects a submenu item following the path. [Dyn Rng (Value)]: Indicates menu items with parameter, (value) shows the current value of the item.

1

Safety Precautions

1.1

Safety Classification



According to the type of protection against electric shock: Class I equipment + internally powered equipment



According to the degree of protection against electric shock: Type-BF applied part



According to the degree of protection against harmful ingress of water: The main unit belongs to IPX0, and the probes belong to IPX7 Footswitch: 971 SWNOM (2-pedal) belongs to IP68 Footswitch: 971 SWNOM (3-pedal) belongs to IP68



According to the degree of safety of application in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE: EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE



According to the mode of operation: CONTINUOUS OPERATION



According to the installation and use: PORTABLE EQUIPMENT MOBILE EQUIPMENT (when the system is installed on the mobile trolley)

Safety Precautions 1-1

1.2

Meaning of Signal Words

In this manual, the signal words"

DANGER”, “

WARNING”,

“ CAUTION”, “NOTE” and "Tips" 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.

Tips

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

1.3

Meaning of Safety Symbols

Symbol

Description Type-BF applied part. 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！ General warning sign. Patient/user infection due to contaminated equipment. Be careful when performing the cleaning, disinfection and sterilization. Patient injury or tissue damage from ultrasound radiation. It is required to practice ALARA when operating ultrasound system.

1-2 Safety Precautions

1.4

Safety Precautions

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

DANGER:

WARNING:

DO NOT use flammable gasses, such as anesthetic gas or hydrogen, or flammable liquids such as ethanol, near this system, because there is danger of explosion. 1.

Do 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 protective grounding performance, and cause the leakage current to exceed safety requirements. Use the cable provided with this system to connect the printer. Other cables may result in electric shock. You must use the power adapter provided with the system; otherwise electric shock may result. You can only adopt the power supply method provided by Mindray, other power supply modes (e.g. using a UPS) may result in electric shock.

2.

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

3.

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 protective grounding may result or a gas explosion may occur.

4.

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

5.

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 or device malfunction may result. If water is accidentally sprayed on or into the system, power off the system immediately and contact Mindray Customer Service Department or sales representative.

Safety Precautions 1-3

1-4 Safety Precautions

6.

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 a damaged or scratched probe is used.

7.

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.

8.

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.

9.

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

10.

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.

11.

DO NOT use this system simultaneously with equipment such as an electrosurgical unit, high-frequency therapy equipment, or a defibrillator, etc. Otherwise, there is a risk of electric shock to the patient.

12.

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

13.

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

14.

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 IEC 60601-1. 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 IEC 60601-1. If you have any questions regarding these requirements, consult your sales representative.

15.

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.

16

The operator SHOULD NOT touch SIP/SOP and the patient at the same time.

17

If the battery cannot be automatically maintained in a fully usable condition, please conduct periodic checking of the battery.