Mindray M6, M6T, M6 Pro, M6 Exp, M55 Operator's Manual
...
M6/M6T/M6 Exp/M6s/M6 Pro/M55/M58/M5 Exp
Diagnostic Ultrasound System
Operator’s Manual
[Basic Volume]
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 ................................................................................................... VI
Conventions ..................................................................................................................................... VI
1 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
2 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 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
2.5 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
2.8.1 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
2.9 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
3.2.1 Connecting the External Power Supply ........................................................................ 3-1
3.2.2 Powered by Batteries ................................................................................................... 3-2
3.3 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
3.4 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
4 Exam Preparation ..................................................................................................... 4-1
4.1 To Start an Exam .................................................................................................................. 4-1
4.2 Patient Information ............................................................................................................... 4-1
4.2.1 New Patient Information ............................................................................................... 4-2
4.2.2 Retrieve Patient Information ......................................................................................... 4-6
4.3 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
4.5.1 Activate an Exam ........................................................................................................ 4-10
4.5.2 Continue an Exam ...................................................................................................... 4-10
4.6 Pause Exam and End Exam .............................................................................................. 4-10
4.6.1 Pause an Exam .......................................................................................................... 4-10
ii
4.6.2 End an Exam .............................................................................................................. 4-11
4.7 Cancel an Exam ................................................................................................................. 4-11
4.8 Anonymous Patient Exam .................................................................................................. 4-12
5 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
5.3.1 B Mode Exam Protocol ................................................................................................. 5-4
5.3.2 B Mode Parameters ...................................................................................................... 5-4
5.3.3 B Mode Image Optimization ......................................................................................... 5-4
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
5.5 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
5.6 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
5.7 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
5.8 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
5.9 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 Splitting Display ............................................................................................................ 6-1
iv
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
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
6.3 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 Cine Memory Setting .................................................................................................... 6-8
6.7 Cine Settings ........................................................................................................................ 6-8
7 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
8 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
9 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
9.1.5 Modifying (Editing) Comments ..................................................................................... 9-4
9.1.6 Deleting Comments ...................................................................................................... 9-4
9.2 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 Probes Cleaning and Disinfection .............................................................................. 12-9
12.1.6 Storage and Transportation ...................................................................................... 12-13
12.2 Biopsy Guide .................................................................................................................... 12-14
12.2.1 Basic Procedures for Biopsy Guiding ....................................................................... 12-16
12.2.2 Needle-guided Brackets ........................................................................................... 12-17
12.2.3 Biopsy Preset ............................................................................................................ 12-25
12.2.4 Needle-guided Bracket Inspection and Installation .................................................. 12-26
12.2.5 Biopsy Menu ............................................................................................................. 12-32
12.2.6 iNeedle ...................................................................................................................... 12-33
12.2.7 Verifying the Biopsy Guide Line ................................................................................ 12-35
12.2.8 Removing the Needle-guided Bracket ...................................................................... 12-36
12.2.9 Clean and Sterilize the Needle-guided Bracket ........................................................ 12-39
12.2.10 Storage and Transportation ...................................................................................... 12-40
12.2.11 Disposal .................................................................................................................... 12-40
12.3 Middle Line ....................................................................................................................... 12-41
13 Recording ................................................................................................................ 13-1
vii
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 ................................................................................................................ 14-13
14.5 Body Mark Preset ............................................................................................................. 14-13
14.5.1 Preset Body Mark for Exam Mode............................................................................ 14-13
14.5.2 User-defined Body Marks ......................................................................................... 14-14
14.5.3 Body Mark Softkey Preset ........................................................................................ 14-17
14.6 Comment Preset .............................................................................................................. 14-17
14.6.1 Custom Comments ................................................................................................... 14-18
14.6.2 Comment Softkey Preset .......................................................................................... 14-18
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 ................................................................................................ 14-21
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
15.3 Installing and Removing the Batteries ................................................................................ 15-2
viii
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
Appendix B
Appendix C
Appendix D
Appendix E
Wireless LAN ........................................................................................A-1
To Use the Lock ....................................................................................B-1
Barcode Reader ....................................................................................C-1
iScanHelper ...........................................................................................D-1
Electrical Safety Inspection ................................................................. E-1
ix
©2017 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2017-11.
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 Ultrasound1.rd@mindray.com.cn for
MindrayVNC ver. 1.0.
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.
MindrayVNC ver. 1.0 is free open source software, the performance of MindrayVNC
ver. 1.0 is not guaranteed by MINDRAY.
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:
E-mail Address: service@mindray.com
Tel:
Fax:
Manufacturer: Mindray DS USA, Inc.
Address: 800 MacArthur Blvd.
Tel: +1(201) 995-8000
Toll Free: +1 (800) 288-2121
Fax: +1 (800) 926-4275
www.mindray.com
+86 755 81888998
+86 755 26582680
Mahwah, NJ 07430-0619 USA
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:
U.S.A. Federal Law restricts this device to sale by or on the
The diagnostic ultrasound system is not intended for
ophthalmic use. Its use in this clinical specialty is
contraindicated.
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
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.
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
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, these conventions are used to describe the buttons on the control panel, the
items in menu, buttons in dialog box and some basic operations:
<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.
VI
1
Safety Precautions
1.1 Safety Classification
According to the type of protection against electric shock:
CLASS I 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 belongs to IP68
Footswitch: SP-997-350 (3-pedal) belongs to IPX8
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"
“
CAUTION
instructions. The signal words and their meanings are defined as follows. Please
understand their meanings clearly before reading this manual.
Signal word Meaning
DANGER
WARNING
CAUTION
NOTE
Tips
”, “NOTE” and "Tips" are used regarding safety and other important
Indicates an imminently hazardous situation that, if not avoided, will
result in death or serious injury.
Indicates a potentially hazardous situation that, if not avoided, could
result in death or serious injury.
Indicates a potentially hazardous situation that, if not avoided, may
result in minor or moderate injury.
Indicates a potentially hazardous situation that, if not avoided, may
result in property damage.
Important information that helps you to operate the system more
effectively.
DANGER
”, “
WARNING
”,
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
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 60601-1-1. 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 60601-1-1. 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.
1-4 Safety Precautions
18 The ultrasound system use a mains plug as isolation
means to the mains power supply. Please do not set the
ultrasound system in a place difficult to operate the
mains plug.
CAUTION:
19 Do not modify this equipment without authorization of
the manufacture.
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:
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.
3. 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 when moving.
Confirm that there is no peripheral device
connected to the system before moving the
system. Otherwise, peripheral device may fall
and injure an individual.
4. DO NOT expose the system to excessive vibration
through transportation. Mechanical damage may result.
Safety Precautions 1-5
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 over current, or when there
is an instantaneous current at power ON, the circuit
breakers and fuses of the building’s supply circuit may
be tripped.
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.
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
normal ultrasound examinations. It is possible for the
surface temperature of the probe to exceed the body
temperature of a patient due to environmental
temperature and exam mode combinations. Apply the
probe 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 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, which will not only
harmful to the human body, but also damage the
accessory.
1-6 Safety Precautions
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. If the system is powered off improperly during
operation, it may result in data damage of the system’s
hard disk or system failure.
13. Do not use the system to examine a fetus for a long
period of time.
14. 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.
15. It is recommended to only use the video devices
specified in this manual.
NOTE: 1. DO NOT use the system in the vicinity of strong electromagnetic field (such
as a transformer), which may affect the performance of the system.
2. DO NOT use the system in the vicinity of high-frequency radiation source,
which may affect the performance of the system or even lead to failure.
3. To avoid damaging the system, DO NOT use it in following environment:
(1) Locations exposed to direct sunlight.
(2) Locations subject to sudden changes in environmental temperature.
(3) Dusty locations.
(4) Locations subject to vibration.
(5) Locations near heat generators.
(6) Locations with high humidity.
16. Do not use gel, disinfectant, probes, probe sheath or
needle-guided brackets that are not compatible with the
system.
17. Read the Acoustic Output Principle in the operation
manual carefully before operate this system on clinical
examination.
18. Please use the ultrasound gel compliant with the
relevant local regulations.
4. 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.
5. When using or placing the system, keep the system horizontal to avoid
imbalance.
6. Remove ultrasound gel from the face of a probe when the examination is
complete. Water in the gel may enter the acoustic lens and adversely affect
the performance and safety of the probe.
7. 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.
8. Do not apply external force to the control panel; otherwise, the system may
be damaged.
9. If the system is used in a small room, the room temperature may rise.
Please provide proper ventilation and free air exchange.
10. 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.
11. 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.
Safety Precautions 1-7
12.
13. Ensure that the current exam date and time are the same as the system
14. DO NOT turn OFF the power supply of the system during printing, file
Please read the following precautions carefully to ensure the safety of the patient and the
operator when using the probes.
WARNING:
The iScape feature constructs a single extended image from a series of
individual image frames. The quality of the final image is user-dependent
and requires skill to efficiently apply the feature and technique. Exercise
caution when measurements are performed from an iScape image.
date and time.
storage or invoking other system operations. An interrupted process may
not be completed, and can become lost or corrupted.
The ultrasonic probe is only for use with the specified
1.
ultrasonic diagnostic system. Please refer to the 2.5
System Configuration to select the proper probe.
Confirm that the probe and cable are normal before and
2.
after each examination. A defective probe may cause
electric shock to the patient.
Do not subject the probe to shock. A defective probe may
3.
cause electric shock to the patient.
CAUTION:
Do not disassemble the probe to avoid the possibility of
4.
electric shock.
Never immerse the probe connector into liquids such as
water or disinfectant because the connector is not
5.
waterproof. Immersion may cause electric shock or
malfunction.
A probe sheath must be installed over the probe before
6.
performing intra-cavity or intra-operative examination.
When using the probe, wear sterile gloves to prevent
1.
infection.
Be sure to use sterile ultrasound gel. Please use the
ultrasound gel compliant with the relevant local
2.
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 normal-temperature burn; however, keeping
3.
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 probe. If the
carrying case is used for storage, it may become a
4.
source of infection.
It is required to practice ALARA when operating
5.
1-8 Safety Precautions
ultrasound system. Minimize the acoustic power without
compromising the quality of images.
The probe and accessories supplied with it are not
6.
delivered disinfected or sterilized. Sterilization (or
high-level disinfect) before use is required.
Disposable components (for example the probe sheath,
the sterile gloves) are packaged sterile and are
single-use only. Do not use if integrity of packaging
7.
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 that
recommended in this operator’s manual; otherwise
Mindray will not be liable for damage caused by other
8.
solutions. If you have any questions, please contact
Mindray Customer Service Department or sales
representative.
The probe sheath contains natural rubber that can cause
9.
allergic reactions in some individuals.
Do not use pre-lubricated condoms as a sheath.
10.
Lubricant may not be compatible with the transducer
material and damage may result.
Transducer damage may be caused by inappropriate gel,
detergent or cleanser:
Do not soak or saturate transducers with solutions
containing alcohol, bleach, ammonium chloride
11.
compounds, acetone or formaldehyde.
Avoid contact with solutions or coupling gels containing
mineral oil or lanolin.
Safety Precautions 1-9
NOTE:
1. Read the following precautions to prevent the probe from malfunction:
Clean and disinfect the probe before and after each examination.
After the examination, wipe off the ultrasound gel thoroughly.
Otherwise, the ultrasound gel may solidify and the image quality
would be degraded.
2. Ambient conditions:
To prevent the probe from being damaged, do not use it where it will be
exposed to:
Direct sunlight or X-rays
Sudden changes in temperature
Dust
Excessive vibration
Heat generators
Use the probes under the following ambient conditions:
ambient temperature: 0℃～ 40℃
relative humidity:30% ～ 85% (no condensation)
atmospheric pressure:700 hPa ～ 1060 hPa.
Use the L16-4Hs and D7-2s probe under the following ambient conditions:
ambient temperature: 10°C ～ 40°C
relative humidity: 30% ～ 85% (no condensation)
atmospheric pressure: 700 hPa ～ 1060 hPa
Use the DE11-3s probe under the following ambient conditions:
ambient temperature: 18°C ～ 30°C
relative humidity: 20% ～ 85% (no condensation)
atmospheric pressure: 700 hPa ～ 1060 hPa
Use the C6-2Gs probe under the following ambient conditions:
ambient temperature: 0°C ～ 40°C
relative humidity: 20% ～ 85% (no condensation)
atmospheric pressure: 700 hPa ～ 1060 hPa
3. Repeated disinfection will eventually damage the probe, please check the
probe's performance periodically.
1-10 Safety Precautions
1.5 Latex Alert
When choosing a probe sheath, it is recommended that you directly contact CIVCO for
obtaining probe sheath, pricing information, samples and local distribution information.
For CIVCO information, please contact the following:
CIVCO Medical Instruments Tel: 1-800-445-6741
WWW.civco.com
WARNING:
Allergic reactions in latex (natural rubber) sensitive patients
may range from mild skin reactions (irritation) to fatal
anaphylactic shock, and may include difficulty in 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).
1.6 Warning Labels
The warning labels are attached to this system in order to call your attention to potential
hazards. The symbol on the warning labels indicates safety precautions.
The warning labels use the same signal words as those used in the operator’s manual.
Read operator’s manual carefully before using the system.
The name, pattern and meaning of each warning label are described as follows:
No. Warning Labels Meaning
1
Read this information carefully before using
the system.
The following labels are available
when the system works with the
mobile trolley.
2
a. Do not place the system on a sloped
surface. Otherwise the system may slide,
resulting in personal injury or the system
malfunction. Two persons are required to
move the system over a sloped surface.
b. Do not sit on the system.
c. DO NOT push the system when the
casters are locked.
Safety Precautions 1-11
No. Warning Labels Meaning
CONFORMS TO AAMI STD 60601-1, IEC
3
STD 60601-2-37，IEC STD 60601-2-18;
CERTIFIED TO CSA STD C22.2 NO.
60601-1, 60601-2-37, 60601-2-18
1-12 Safety Precautions
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