Mindray M5 User manual
M5 Diagnostic Ultrasound
System
Operator’s Manual
[Basic Volume]
i
Table of Contents
Table of Contents ................................................................................................................... i
Intellectual Property Statement .......................................................................................................... I
Warranty ............................................................................................................................................ II
Customer Service Department .................................................................................................... III
Important Information ....................................................................................................................... III
Introduction.......................................................................................................................................IV
Safety Precautions...............................................................................................................VI
1Overview ......................................................................................................................1-1
1.1Intended Use ........................................................................................................................1-1
1.2Contraindication....................................................................................................................1-1
1.3Product and Model Code...................................................................................................... 1-1
2Product Specifications ...............................................................................................2-1
2.1Imaging Modes .....................................................................................................................2-1
2.2Power Supply (Adapter) .......................................................................................................2-1
2.3Environmental Conditions ....................................................................................................2-1
2.4External Dimensions and Weight .........................................................................................2-1
3System Configuration.................................................................................................3-1
3.1Standard Configuration.........................................................................................................3-1
3.2Probes and Needle-guided Brackets Available ....................................................................3-1
3.3Options .................................................................................................................................3-3
3.4Peripherals Supported..........................................................................................................3-4
4System Introduction....................................................................................................4-1
4.1Introduction of Each Unit ......................................................................................................4-1
4.2Extend Modules....................................................................................................................4-3
4.2.1Probe Extend Module ...................................................................................................4-3
4.2.2IO Extend Module .........................................................................................................4-4
4.2.3V/A Extend Module .......................................................................................................4-5
4.2.4ECG Module .................................................................................................................4-5
4.3Control Panel........................................................................................................................4-6
4.4Symbols................................................................................................................................ 4-9
5Set-up & Connections.................................................................................................5-1
5.1System Set-up ......................................................................................................................5-1
5.2Power Supply .......................................................................................................................5-1
ii
5.2.1Connecting the External Power Supply ........................................................................5-1
5.2.2Powered by Batteries....................................................................................................5-1
5.3Connecting / Disconnecting a Transducer ...........................................................................5-2
5.3.1Connecting a Transducer..............................................................................................5-2
5.3.2Disconnecting a Transducer .........................................................................................5-3
5.4Connecting the Probe Extend Module .................................................................................5-3
5.5Connecting IO Extend Module .............................................................................................5-4
5.6Connecting the V/A Extend Module......................................................................................5-4
5.7Connecting the ECG Module................................................................................................ 5-4
5.8Connecting the Footswitch ...................................................................................................5-5
5.9Connecting / Removing a USB Memory Device ..................................................................5-5
5.10Installing a Graph / Text Printer ............................................................................................5-6
5.11Installing a Video Printer.......................................................................................................5-7
5.12Use of M-Pack ......................................................................................................................5-9
5.12.1Introduction of M-Pack..................................................................................................5-9
5.12.2Use of M-Pack ............................................................................................................5-10
6Power ON / OFF ...........................................................................................................6-1
6.1Powering ON the System .....................................................................................................6-1
6.2Powering OFF the System ...................................................................................................6-3
7Basic Screen and Operation ......................................................................................7-1
7.1Basic Screen ........................................................................................................................7-1
7.1.1Information Area............................................................................................................7-1
7.1.2Image Parameter and Menu Area.................................................................................7-3
7.1.3Image-in-Image Thumbnail...........................................................................................7-3
7.1.4Image Area....................................................................................................................7-3
7.1.5Thumbnail Area of Images Saved.................................................................................7-4
7.1.6Body Mark Area ............................................................................................................7-4
7.1.7Area of Help Information and Cursor Icon ....................................................................7-4
7.1.8Soft Menu Area .............................................................................................................7-4
7.1.9System Status Area.......................................................................................................7-5
7.1.10Measurement Result Window....................................................................................... 7-5
7.2Basic Operations of Screens................................................................................................7-5
8Exam Preparation........................................................................................................8-1
8.1To Start an Exam .................................................................................................................. 8-1
8.2Patient Information ...............................................................................................................8-1
8.2.1New Patient Information ...............................................................................................8-1
8.2.2Retrieve Patient Information from iStation ....................................................................8-5
8.2.3Retrieve Patient Information from Worklist ...................................................................8-6
iii
8.3Pause Exam & Continue Exam ............................................................................................8-8
8.3.1Pause Exam..................................................................................................................8-8
8.3.2Continue Exam .............................................................................................................8-8
8.4End Exam .............................................................................................................................8-8
8.5Activate Exam....................................................................................................................... 8-9
8.6Cancel an Exam ...................................................................................................................8-9
8.7Anonymous Patient Exam ....................................................................................................8-9
9Exam Types..................................................................................................................9-1
9.1Introduction of Exam Types..................................................................................................9-1
9.2Selecting Transducer and Exam Type.................................................................................. 9-2
9.3Setting Exam Types..............................................................................................................9-3
9.3.1Exam Selection ............................................................................................................. 9-3
9.3.2Exam Configuration ......................................................................................................9-4
9.3.3User-defined Exam Types.............................................................................................9-6
10Image Modes..............................................................................................................10-1
10.1Image Modes......................................................................................................................10-1
10.2Switching Between Image Modes ......................................................................................10-2
10.3Image Adjustments ............................................................................................................. 10-3
10.3.1B Mode........................................................................................................................10-3
10.3.2M Mode .......................................................................................................................10-8
10.3.3Color Mode ................................................................................................................. 10-9
10.3.4Power / DirPower Mode............................................................................................10-12
10.3.5PW/CW Doppler Mode .............................................................................................10-12
10.3.6Image Magnification..................................................................................................10-16
10.3.7iZoom (Full-screen Zooming)....................................................................................10-16
10.4Image Parameter Preset ..................................................................................................10-17
11Special Imaging Modes............................................................................................. 11-1
11.1Smart3D ............................................................................................................................. 11-1
11.1.1Note before Use.......................................................................................................... 11-1
11.1.2Smart3D Presetting..................................................................................................... 11-3
11.1.3Enter/ Exit Smart3D .................................................................................................... 11-5
11.1.43D Image Capture....................................................................................................... 11-6
11.1.5Procedures.................................................................................................................. 11-7
11.1.63D Image Browsing .................................................................................................... 11-8
11.1.7Reset ROI ................................................................................................................. 11-17
11.1.83D Image Storage and Review ................................................................................. 11-17
11.2iScape............................................................................................................................... 11-17
11.2.1Enter or Exit iScape .................................................................................................. 11-18
iv
11.2.2Capture Images ........................................................................................................ 11-18
11.2.3Review the Extended Image..................................................................................... 11-19
11.2.4Review the Captured Images Frame by Frame........................................................ 11-20
11.2.5Save and Open Images ............................................................................................ 11-20
11.3Free Xros M Mode............................................................................................................ 11-20
11.3.1Settings for Free Xros M ........................................................................................... 11-21
11.3.2Enter/Exit Free Xros M ............................................................................................. 11-21
11.3.3Imaging ..................................................................................................................... 11-21
11.3.4Free Xros M Image Parameters ............................................................................... 11-22
12Cine Review ...............................................................................................................12-1
12.1Entering / Exiting Cine Review ...........................................................................................12-1
12.2Cine Review in the B or C Mode ........................................................................................12-1
12.2.1Manual Cine Review...................................................................................................12-1
12.2.2Auto Cine Review .......................................................................................................12-2
12.3Cine Review in the M or D Mode........................................................................................12-2
12.4Linked Cine Review............................................................................................................12-2
12.5Setting Region of Auto Review...........................................................................................12-3
12.6Saving Cine ........................................................................................................................12-3
12.7Cine Setup..........................................................................................................................12-4
12.7.1Setting Cine Length ....................................................................................................12-4
12.7.2Setting Cine Memory Split ..........................................................................................12-4
13Measurements ...........................................................................................................13-1
13.1Basic Operations ................................................................................................................13-1
13.1.1Entering Measurement Status ....................................................................................13-1
13.1.2Measurement Result and Help Information ................................................................13-1
13.2General Measurements......................................................................................................13-2
13.2.1General Measurements – 2D...................................................................................... 13-2
13.2.2General Measurements - M Mode ..............................................................................13-2
13.2.3General Measurements - Doppler ..............................................................................13-3
13.3Application Measurements .................................................................................................13-3
14Comments (Annotations)..........................................................................................14-1
14.1Entering / Exiting Comments..............................................................................................14-1
14.2Comment Menu .................................................................................................................. 14-1
14.2.1Comment Text Library Menu.......................................................................................14-1
14.2.2Soft Menu for Comments ............................................................................................14-2
14.3Adding Comments ..............................................................................................................14-3
14.3.1Typing Comment Characters ......................................................................................14-3
14.3.2Adding a Comment Text..............................................................................................14-3
v
14.3.3Adding an Arrow.......................................................................................................... 14-4
14.4Moving Comments..............................................................................................................14-4
14.5Modifying (Editing) Comments ...........................................................................................14-4
14.5.1Modifying (Editing) Characters ...................................................................................14-4
14.5.2Modifying (Editing) Arrows .......................................................................................... 14-5
14.6Deleting Comments ............................................................................................................14-5
14.6.1Deleting Comment Characters, Texts or Arrows.........................................................14-5
14.6.2Deleting a Recently-Added Character, Text or Arrow .................................................14-5
14.6.3Delete Word ................................................................................................................14-5
14.6.4Deleting all Comments (Characters, Texts or Arrows) ................................................14-6
14.7Comment Preset.................................................................................................................14-6
14.7.1Font Size and Arrow Size ...........................................................................................14-6
14.7.2User-defined Comments.............................................................................................14-7
15Body Marks (Pictograms) .........................................................................................15-1
15.1Entering / Exiting Body Mark Mode .................................................................................... 15-1
15.2Categories of Body Marks ..................................................................................................15-1
15.3Soft Menu for Body Marks..................................................................................................15-1
15.4Adding Body Marks ............................................................................................................15-1
15.5Moving Body Marks............................................................................................................15-2
15.6Deleting Body Marks ..........................................................................................................15-3
15.7Body Mark Preset...............................................................................................................15-3
16Patient Data Management.........................................................................................16-1
16.1Patient Information Management ....................................................................................... 16-1
16.1.1Enter Patient Information ............................................................................................16-1
16.1.2Patient Information Setting .........................................................................................16-1
16.2Image File Management..................................................................................................... 16-2
16.2.1Memory Media ............................................................................................................16-2
16.2.2Image File Formats ..................................................................................................... 16-2
16.2.3Image Storage Preset .................................................................................................16-3
16.2.4Saving Images to the System .....................................................................................16-3
16.2.5Quickly Saving Images to USB Flash Drive ...............................................................16-4
16.2.6Quickly Saving Full Screen Image to the System.......................................................16-5
16.2.7Thumbnails .................................................................................................................16-5
16.2.8Image Review and Analysis........................................................................................16-5
16.2.9iVision..........................................................................................................................16-7
16.2.10Sending Image File.....................................................................................................16-9
16.3Report Management.........................................................................................................16-10
16.4Patient Data Management (iStation) ................................................................................ 16-11
vi
16.4.1Viewing Patient Information ......................................................................................16-12
16.4.2Searching a Patient ..................................................................................................16-12
16.4.3Patient Data Management ........................................................................................16-13
16.4.4Examinations ............................................................................................................16-14
16.5Network Storage...............................................................................................................16-14
16.5.1Network Storage Setting ...........................................................................................16-15
16.5.2Network Storage .......................................................................................................16-16
16.6Print Task Management....................................................................................................16-16
16.7Backing Up and Erasing Files through DVD Drive...........................................................16-17
16.8Task manager ...................................................................................................................16-18
16.9Reviewing the AVI Files .................................................................................................... 16-20
16.10Admin ...............................................................................................................................16-20
16.10.1Access Setting ..........................................................................................................16-20
16.10.2Setting Access Control..............................................................................................16-20
16.10.3System Login ............................................................................................................16-20
16.10.4Add/ Delete a User....................................................................................................16-21
16.10.5Modify Password.......................................................................................................16-23
17Parameter Setup........................................................................................................17-1
17.1Entering / Exiting Setup......................................................................................................17-1
17.2System Setup .....................................................................................................................17-2
17.3Exam Mode Preset.............................................................................................................17-4
17.4Image Parameter Preset ....................................................................................................17-5
17.5Comment Preset.................................................................................................................17-5
17.6Body Mark Preset...............................................................................................................17-5
17.7Measurement Preset ..........................................................................................................17-5
17.8Soft-key and Menu Preset..................................................................................................17-5
17.9Peripheral Setup.................................................................................................................17-8
17.10Network Preset .................................................................................................................17-10
17.11Manage Settings...............................................................................................................17-10
17.11.1Exporting Setup Data................................................................................................17-10
17.11.2Importing Setup Data ................................................................................................ 17-11
17.12Maintenance ..................................................................................................................... 17-11
17.13System Information........................................................................................................... 17-11
18Probes and Biopsy....................................................................................................18-1
18.1Probes ................................................................................................................................ 18-1
18.1.1Name and Function of Each Part of the Probe...........................................................18-3
18.1.2Orientation of the Ultrasound Image and the Probe Head .........................................18-7
18.1.3Procedures for Operating ...........................................................................................18-7
vii
18.1.4Wearing the Probe Sheath .......................................................................................18-10
18.1.5When the Immersion Method is used (for 6LB7s and 6LE7s).................................. 18-11
18.1.6Probes Cleaning and Disinfection (or Sterilization) .................................................. 18-15
18.1.7Storage and Transportation ......................................................................................18-19
18.2Biopsy Guide ....................................................................................................................18-19
18.2.1Needle-guided Brackets............................................................................................18-21
18.2.2Names of Parts .........................................................................................................18-21
18.2.3Needle-guided Bracket Inspection and Installation ..................................................18-35
18.2.4Entering or Exiting Biopsy Menu...............................................................................18-43
18.2.5Displaying Biopsy Guide Lines .................................................................................18-44
18.2.6Verifying the Biopsy Guide Line................................................................................18-44
18.2.7Removing the Needle-guided Bracket......................................................................18-45
18.2.8Clean and Sterilize the Needle-guided Bracket ........................................................18-49
18.2.9Storage and Transportation ......................................................................................18-50
18.2.10Disposal ....................................................................................................................18-51
19ECG ............................................................................................................................19-1
19.1ECG Connection.................................................................................................................19-1
19.2Displaying ECG Signal .......................................................................................................19-2
19.3ECG Triggering................................................................................................................... 19-2
19.3.1ECG Triggering ...........................................................................................................19-2
19.3.2Triggering Mode..........................................................................................................19-3
19.3.3Real & Trigger .............................................................................................................19-3
19.4ECG Review .......................................................................................................................19-3
19.5Exiting ECG ........................................................................................................................19-3
19.6Setting ECG........................................................................................................................ 19-3
20Image Recording .......................................................................................................20-1
20.1VCR (Video Cassette Recorder) ........................................................................................20-1
20.1.1Setup...........................................................................................................................20-1
20.1.2Record ........................................................................................................................20-1
20.1.3Replay.........................................................................................................................20-2
20.2DVR (Digital Video Recorder).............................................................................................20-3
20.2.1Setup...........................................................................................................................20-3
20.2.2Entering/Exiting DVR .................................................................................................. 20-4
20.2.3Record ........................................................................................................................20-4
20.2.4Data Management ......................................................................................................20-5
20.2.5Video Replay...............................................................................................................20-7
20.3Non-programmable Record and Replay ............................................................................20-9
21Batteries.....................................................................................................................21-1
viii
21.1Overview.............................................................................................................................21-1
21.2Precautions.........................................................................................................................21-1
21.3Installing and Removing the Batteries................................................................................21-2
21.4Battery Status Indicator ......................................................................................................21-3
21.5One Full Discharge / Charge Cycle....................................................................................21-3
21.6Checking Battery Performance ..........................................................................................21-4
21.7Battery Disposal .................................................................................................................21-4
22System Maintenance.................................................................................................22-1
22.1Daily Maintenance..............................................................................................................22-1
22.1.1Cleaning the System................................................................................................... 22-1
22.1.2Backup of the System Hard Disk ................................................................................22-4
22.2Maintenance Checks by Service Engineer ........................................................................22-5
22.3Consumables and Periodic Part Replacement ..................................................................22-5
22.4Troubleshooting ..................................................................................................................22-5
23Acoustic Output ........................................................................................................23-1
23.1Concerns with Bioeffects .................................................................................................... 23-1
23.2Prudent Use Statement ......................................................................................................23-1
23.3ALARA Principle (As Low As Reasonably Achievable) ...................................................... 23-2
23.4MI/TI Explanation................................................................................................................23-2
23.4.1Basic Knowledge of MI and TI ....................................................................................23-2
23.4.2MI/TI Display ............................................................................................................... 23-3
23.5Acoustic Power Setting ...................................................................................................... 23-3
23.6Acoustic Power Control ......................................................................................................23-4
23.7Acoustic Output ..................................................................................................................23-5
23.7.1Derated Ultrasonic Output Parameters.......................................................................23-5
23.7.2Differences between Actual and Displayed MI and TI ................................................23-5
23.8Measurement Uncertainty ..................................................................................................23-6
23.9References for Acoustic Power and Safety ........................................................................23-6
24Measurement Accuracy ............................................................................................24-1
25Safety Classification .................................................................................................25-1
26Guidance and Manufacturer's Declaration .............................................................26-1
Appendix AWireless LAN.......................................................................................... A-1
Appendix BDICOM..................................................................................................... B-1
Appendix CRemote Control and Net Update .......................................................... C-1
Appendix DElectrical Safety Inspection .................................................................. D-1
I
© 2010-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2016-09.
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.
,, , , BeneView, WATO,
BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and other
countries. All other trademarks that appear in this manual are used only for informational or
editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for
errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:
zall installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel;
zthe electrical installation of the relevant room complies with the applicable national
and local requirements; and
zthe product is used in accordance with the instructions for use.
II
zMindrayVNC 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.
Definitions
zMain unit: Integrated facilities which implements the specified function separately.
Generally speaking, the main unit should include power supply, control system
and some functional modules.
zAccessories: Materials connected to the main unit to extend or implement
specified function.
zConsumables: Disposable or short-life parts which should be replaced each time
after use or periodically.
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:
III
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.
Customer Service Department
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
Important Information
1. It is the customer’s responsibility to maintain and manage the system after delivery.
2. The warranty does not cover the following items, even during the warranty period:
a. Damage or loss due to misuse or abuse.
b. Damage or loss caused by Acts of God such as fires, earthquakes, floods,
lightning, etc.
c. Damage or loss caused by failure to meet the specified conditions for this system,
such as inadequate power supply, improper installation or environmental
conditions.
d. Damage or loss due to use of the system outside the region where the system
was originally sold.
e. Damage or loss involving the system purchased from a source other than Mindray
or its authorized agents.
3. This system shall not be used by persons other than fully qualified and certified medical
personnel.
4. Do not make changes or modifications to the software or hardware of this system.
5. In no event shall Mindray be liable for problems, damage, or loss caused by relocation,
modification, or repair performed by personnel other than those designated by Mindray.
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
Tel: +86 755 81888998
Fax: +86 755 26582680
IV
6. The purpose of this system is to provide physicians with data for clinical diagnosis.
7. It is the physician’s responsibility for diagnostic procedures. Mindray shall not be liable for
the results of diagnostic procedures.
8. Important data must be backed up on external memory media.
9. Mindray shall not be liable for loss of data stored in the memory of this system caused by
operator error or accidents.
10. 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.
11. If the manager for this system is changed, be sure to hand over this operator’s manual to
the new manager.
Introduction
This operator’s manual describes the operating procedures for this diagnostic ultrasound
system. To ensure safe and correct operations, carefully read and understand the manual
before operating the system.
1．Notation Conventions
In this operator’s manual, the following words are used besides the safety precautions (refer
to "Safety Precautions"). Please read this operator’s manual before using the system.
NOTE: Indicates information of interest to users of this system as to
exceptional conditions or operating procedures.
CAUTION: The diagnostic ultrasound system is not intended for
ophthalmic use. Its use in this clinical specialty is
contraindicated.
2．Operator’s Manuals
You may receive multi-language manuals in compact disc or paper. Please refer to
English manual for latest information and register information.
The content of the operator manual, such as screens, menus or descriptions, may be
different from what you see in your system. The content varies depending upon the
software version, options and configuration of the system.
1) Manuals on Paper
zOperator’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.
zOperator’s Manual [Advanced Volume]
Describes measurement preset, measurements and calculations, etc.
zOperator’s Manual [Acoustic Power Data and Surface Temperature Data]
Contains data tables of acoustic output for transducers.
zOperation Note
Contains quick guide for basic operations of the system.
V
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.
3．Content of Operator’s Manual
The content of the operator manual, such as screens, menus or descriptions, may be different
from what you see in your system. The content varies depending upon the software version,
options and configuration of the system.
VI
Safety Precautions
1. Meaning of Signal Words
In this operator’s manual, the signal words DANGER, WARNING,
CAUTION and NOTE are used regarding safety and other important instructions. The
signal words and their meanings are defined as follows. Please understand their meaning
before reading this manual.
Signal word Meaning
DANGER Indicates an imminently hazardous situation that, if not avoided, will
result in death or serious injury.
WARNING Indicates a potentially hazardous situation that, if not avoided, could
result in death or serious injury.
CAUTION Indicates a potentially hazardous situation that, if not avoided, may
result in minor or moderate injury.
NOTE Indicates a potentially hazardous situation that, if not avoided, may
result in property damage.
2. Meaning of Safety Symbols
Symbol Description
Type-BF applied part
The ultrasound transducers connected to this system are
Type-BF applied parts.
The ECG module connected to this system is Type-BF applied
part.
Caution
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.
VII
3. Safety Precautions
Please observe the following precautions to ensure patient’s and operator’s safety when using
this system.
DANGER: Do not use flammable gasses, such as anesthetic gas,
oxygen or hydrogen, or flammable liquids such as ethanol,
near this system or the probe, because there is danger of
explosion.
WARNING: 1. Connect the adapter power plug of this system and
power plugs of the peripherals to wall receptacles
that meet the ratings indicated on the rating
nameplate. Using a multifunctional receptacle may
affect the system grounding performance, and cause
the leakage current to exceed safety requirements.
You must use the power adapter provided with the
system; otherwise electric shock may result.
2. Use the printing cable provided with this system to
connect the printer. Electric shock may result.
3. Connect the grounding conductor before turning ON
the system. Disconnect the grounding cable after
turning OFF the system. Otherwise, electric shock
may result.
4. For the connection of power and grounding, follow
the appropriate procedures described in this
operator’s manual. Otherwise, there is risk of electric
shock. Do not connect the grounding cable to a gas
pipe or water pipe; otherwise improper grounding
may result or a gas explosion may occur.
5. Before cleaning the system, disconnect the power
cord from the outlet. System failure and electric
shock may result.
6. This system is not water-proof. Do not use this
system in any place where water leakage may occur.
If any water is sprayed on or into the system, electric
shock may result. If water is accidentally sprayed on
or into the system, contact Mindray Customer
Service Department or sales representative.
7. Store and use the transducers carefully. Do not use a
transducer that has a damaged, scratched surface,
or exposed wiring of any kind. Immediately stop
using the transducer and contact Mindray Customer
Service Department or sales representative.
8. Do not allow the patient to contact the live parts of
the ultrasound system or other devices, e.g. signal I /
O ports. Electric shock may occur.
9. Only use the transducers provided by Mindray.
Otherwise, the system or the transducer may be
damaged, causing a profound failure, e.g. a fire in the
worst case.
VIII
10. Do not subject the transducers to knocks or drops.
Use of a defective transducer may cause an electric
shock.
11. Do not open the covers and front panel of the
system. Short circuit or electric shock may result
when the system hardware is exposed and powered
on.
12. Do not use this system simultaneously with
equipment such as an electrosurgical unit,
high-frequency therapy equipment, or a defibrillator,
etc.; otherwise electric shock may result.
13. Only use the ECG leads provided with the ECG
module; otherwise electric shock may result.
14. When moving the system, you should first fold the
LCD display, disconnect the system from other
devices (including transducers) and disconnect the
system from the power supply.
15. Accessory equipment connected to the analog and
digital interfaces must comply with the relevant IEC
standards (e.g., IEC 60950 information technology
equipment safety standard and IEC 60601-1 medical
equipment standard). Furthermore all configurations
must comply with the standard IEC60601-1-1. It is the
responsibility of the person, who connects additional
equipment to the signal input or output ports and
configures a medical system, to verify that the
system complies with the requirements of
IEC60601-1-1. If you have any questions regarding
these requirements, consult your sales
representative.
16. Prolonged and repeated use of keyboards may result
in hand or arm nerve disorders for some individuals.
Observe the local safety or health regulations
concerning the use of keyboards.
CAUTION: 1. Precautions concerning clinical examination
techniques:
This system must be used only by qualified medical
professionals.
This operator’s manual does not describe clinical
examination techniques. The clinician should select the
proper examination techniques based on specialized
training and clinical experience.
IX
2. Malfunctions due to radio wave:
zIf a radio wave emitting device is used in the
proximity of this system, it may interfere with
operations. Do not bring or use devices that
generate radio waves, such as cellular
telephones, transceivers, and radio
controlled toys, in the room where the
system is installed.
zIf 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.
Fasten and fully secure any peripheral device before
moving the system. A loose peripheral device may fall
and injure an individual.
4. Do not expose the system to excessive vibration
through transportation. Mechanical damage may result.
5. Do not connect this system to outlets with the same
circuit breakers and fuses that control the current of
devices such as life-support systems. If this system
malfunctions and generates overcurrent, or when there
is an instantaneous current at power ON, the circuit
breakers and fuses of the building’s supply circuit may
be tripped.
6. Always keep the system dry. Avoid transporting this
system quickly from a cold place to a warm place;
otherwise condensation or water droplets may form
allowing a short circuit and possible electric shock.
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.
X
8. There is no risk of high-temperature burns during
routine ultrasound examinations. It is possible for the
surface temperature of the transducer to exceed the
body temperature of a patient due to environmental
temperature and exam type combinations. If a patient
complains of any excessive heat from the transducer,
immediately stop scanning. To prevent patient burns,
ensure there is no surface damage to the transducer.
Do not apply the transducer to the same region on the
patient for a long time. Apply the transducer only for a
period of time required for the purpose of diagnosis.
9. The system and its accessories are not disinfected or
sterilized prior to delivery. The operator is responsible
for the cleaning and disinfection of transducers and
sterilization of biopsy brackets according to the
manuals, prior to the use. All items must be thoroughly
processed to completely remove harmful residual
chemicals or gasses that are harmful to the human
body or that may damage the accessory.
10. It is necessary to press [End Exam] to end the current
scan that is in progress and clear the current Patient
Information field. Otherwise new patient data may be
combined with the previous patient data.
11. Do not connect or disconnect the system’s power cord
or its accessories (e.g., a printer or a recorder) without
turning OFF the power first. This may damage the
system and its accessories or cause electric shock.
12. Do not turn OFF the power supply of the system during
printing, file storage or invoking other system
operations. An interrupted process may not be
completed, and can become lost or corrupted.
13. If the system is powered off improperly during
operation, it may result in data damage of the system’s
hard disk or system failure.
14. Do not use the system to examine a fetus in the Doppler
mode for a long period of time.
15. Do not use a USB memory device (e.g., a USB flash
drive, removable hard disk) which has unsafe data.
Otherwise system damage may result.
16. It is recommended to only use the video devices
specified in this manual.
17. Please clean the dust nets periodically (e.g. once in a
month) to keep good ventilation. Otherwise, the system
may be damaged.
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.
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