Mindray Resona I9W User manual

Resona I9/Resona I9 Exp/Resona I9S/Resona
I9T/Resona I9 Easi/Resona I9 Nasa/Resona
IV/Imagyn I9/Imagyn I9S/Imagyn I9 Easi/Nuewa
I9/Nuewa I9S/Nuewa I9 Easi/Anesus I9/Anesus I9
Easi/Eagus I9/Nuewa I9T/Nuewa I9 Exp/Resona
I9W/Recho R9W/Recho R9/Recho R9 Pro/Recho
R9 Exp/Recho R9S/Recho R9T/Recho R9 Super
Diagnostic Ultrasound System
Operator’s Manual
[Basic Volume]

i
Contents
Intellectual Property Statement .......................................................................................................... I
Responsibility on the Manufacturer Party........................................................................................... I
Warranty ............................................................................................................................................ II
Important Information ....................................................................................................................... III
About This Manual............................................................................................................................ III
Notation Conventions ....................................................................................................................... III
Operator’s Manuals ..........................................................................................................................IV
Hardcopy Manuals............................................................................................................................IV
Software Interfaces in this Manual ...................................................................................................IV
Conventions.......................................................................................................................................V
Notification of Adverse Events...........................................................................................................V
Product Differences ...........................................................................................................................V
1Safety 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.............................................................................................................................1-9
1.6 Warning Labels.....................................................................................................................1-9
2System Overview ........................................................................................................2-1
2.1 Intended Use ........................................................................................................................2-1
2.2 Contraindication....................................................................................................................2-1
2.3 Product Specifications..........................................................................................................2-1
2.4 System Configuration ...........................................................................................................2-2
2.5 Introduction of Each Unit ......................................................................................................2-8
2.6 Back I/O Panel.................................................................................................................... 2-11
2.7 Power Supply Panel ...........................................................................................................2-12
2.8 Front I/O Panel ...................................................................................................................2-13
2.9 Control Panel......................................................................................................................2-14
2.10 Symbols..............................................................................................................................2-18
3System Preparation.....................................................................................................3-1
3.1 Moving/Position the System .................................................................................................3-1
3.2 Connecting Power Cord & Protective Grounding.................................................................3-2
3.3 Monitor Adjustment...............................................................................................................3-5
3.4 Control Panel Position Adjustment.......................................................................................3-8
3.5 Connecting/Disconnecting a Probe......................................................................................3-8
3.6 Connecting Peripheral Devices .......................................................................................... 3-11
3.7 Basic Screen & Operation ..................................................................................................3-15
4Exam Preparation........................................................................................................4-1
4.1 Patient Information ...............................................................................................................4-1
4.2 Select Exam Mode and Probe..............................................................................................4-9
4.3 Selecting Imaging Mode.....................................................................................................4-10
4.4 Activate& Continue an Exam..............................................................................................4-10
4.5 Pause & Continue an Exam ............................................................................................... 4-11
5Image Optimization .....................................................................................................5-1
5.1 Imaging Mode.......................................................................................................................5-1

ii
5.2 B-mode Image Optimizing....................................................................................................5-4
5.3 M Mode Image Optimization .............................................................................................. 5-11
5.4 Color Mode Image Optimization.........................................................................................5-13
5.5 Power Mode Image Optimization .......................................................................................5-18
5.6 V Flow.................................................................................................................................5-20
5.7 PW/CW Mode Optimization................................................................................................5-23
5.8 Color M Mode (CM)............................................................................................................5-29
5.9 Free Xros M Mode..............................................................................................................5-30
5.10 TDI......................................................................................................................................5-32
5.11 3D/4D .................................................................................................................................5-36
5.12 iScape View........................................................................................................................5-81
5.13 Contrast Imaging ................................................................................................................5-84
5.14 Elastography.......................................................................................................................5-91
5.15 Stress Echo ......................................................................................................................5-102
5.16 Tissue Tracking Quantitative Analysis.............................................................................. 5-110
5.17 Fusion Imaging................................................................................................................. 5-116
5.18 RIMT (Real-time Intima-Media Thickness).......................................................................5-142
5.19 R-VQS ..............................................................................................................................5-143
5.20 Smart Pelvic Floor ............................................................................................................5-145
5.21 Smart Fetal HR (Heart Rate)............................................................................................5-147
5.22 Smart VTI .........................................................................................................................5-147
5.23 Smart IVC .........................................................................................................................5-148
5.24 Smart B-line......................................................................................................................5-150
6Display & Cine Review................................................................................................6-1
6.1 Splitting Display....................................................................................................................6-1
6.2 Image Magnification .............................................................................................................6-1
6.3 Freeze/Unfreeze the Image..................................................................................................6-2
6.4 Cine Review .........................................................................................................................6-3
6.5 Image Compare....................................................................................................................6-5
6.6 Cine Saving ..........................................................................................................................6-7
6.7 Setting Cine Length..............................................................................................................6-7
7Physiological Unit Signal ...........................................................................................7-1
7.1 ECG......................................................................................................................................7-2
7.2 Respiratory Wave .................................................................................................................7-3
8Measurement ...............................................................................................................8-1
8.1 Basic Operations ..................................................................................................................8-1
8.2 General Measurements........................................................................................................8-2
8.3 Application Measurements ...................................................................................................8-4
8.4 Measurement Accuracy........................................................................................................8-5
9Comments and Body Mark .........................................................................................9-1
9.1 Comments ............................................................................................................................9-1
9.2 Voice Comments ..................................................................................................................9-5
9.3 Body Mark ............................................................................................................................9-6
10 Patient Data Management.........................................................................................10-1
10.1 Enter Patient Information....................................................................................................10-1
10.2 Image File Management.....................................................................................................10-1
10.3 Report Management...........................................................................................................10-9
10.4 Patient Data Management (iStation) ................................................................................10-10
10.5 iStorage ............................................................................................................................10-14

iii
10.6 Print ..................................................................................................................................10-15
10.7 Back up Files using the DVD Drive ..................................................................................10-16
10.8 Patient Task Management................................................................................................10-16
10.9 Administration...................................................................................................................10-17
10.10 Q-Path ..............................................................................................................................10-25
10.11 V-Access...........................................................................................................................10-26
11 DICOM/HL7.................................................................................................................11-1
11.1 DICOM Preset .................................................................................................................... 11-1
11.2 DICOM Verifying............................................................................................................... 11-16
11.3 DICOM Services............................................................................................................... 11-16
11.4 DICOM Media Storage (DICOMDIR Review) .................................................................. 11-21
12 Setup ..........................................................................................................................12-1
12.1 System Preset ....................................................................................................................12-1
12.2 Exam Mode Preset.............................................................................................................12-9
12.3 Measurement Preset ........................................................................................................12-10
12.4 Comment Preset...............................................................................................................12-10
12.5 iWorks Preset ................................................................................................................... 12-11
12.6 Stress Echo Preset........................................................................................................... 12-11
12.7 DICOM/HL7 Preset .......................................................................................................... 12-11
12.8 Network Preset.................................................................................................................12-12
12.9 Print Preset.......................................................................................................................12-15
12.10 Maintenance .....................................................................................................................12-16
12.11 Security.............................................................................................................................12-17
12.12 System Information...........................................................................................................12-18
13 Probes and Biopsy....................................................................................................13-1
13.1 Probes ................................................................................................................................13-1
13.2 Biopsy Guide ....................................................................................................................13-19
13.3 Needle Navigation Guiding...............................................................................................13-47
13.4 Middle Line .......................................................................................................................13-58
14 DVR Recording..........................................................................................................14-1
14.1 DVR Recording...................................................................................................................14-1
14.2 Send Image ........................................................................................................................14-1
14.3 DVR Video Replay..............................................................................................................14-2
15 Acoustic Output ........................................................................................................15-1
15.1 Concerns with Bioeffects....................................................................................................15-1
15.2 Prudent Use Statement ......................................................................................................15-1
15.3 ALARA Principle (As Low As Reasonably Achievable) ......................................................15-1
15.4 MI/TI Explanation................................................................................................................15-2
15.5 Acoustic Power Setting ......................................................................................................15-3
15.6 Acoustic Power Control ......................................................................................................15-3
15.7 Acoustic Output ..................................................................................................................15-4
15.8 Measurement Uncertainty ..................................................................................................15-5
15.9 References for Acoustic Power and Safety........................................................................15-6
16 EMC Guidance and Manufacturer’s Declaration ....................................................16-1
17 System Maintenance.................................................................................................17-1
17.1 Daily Maintenance..............................................................................................................17-1
17.2 Common inspections..........................................................................................................17-6
17.3 System Function Inspection ...............................................................................................17-7

iv
17.4 Inspection of Peripherals and Optional Functions..............................................................17-8
Appendix A Barcode Reader ..................................................................................... A-1
Appendix B iWorks (Auto Workflow Protocol)......................................................... B-1
Appendix C Wireless LAN.......................................................................................... C-1
Appendix D Ultrasound Gel Heater........................................................................... D-1
Appendix E Electrical Safety Inspection .................................................................. E-1
Appendix F Battery .....................................................................................................F-1
Appendix G List of Vocal Commands ....................................................................... G-1
Appendix H Operating Environment......................................................................... H-1
Appendix I Indications For Use .................................................................................I-1

I
©2024 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2024-01.
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.
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for errors
contained herein or for incidental or consequential damages in connection with the furnishing,
performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
all installation operations, expansions, changes, modifications and repairs of this product are
conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and local
requirements; and
the product is used in accordance with the instructions for use.
NOTE
This equipment must be operated by skilled/trained clinical professionals.
Warning
It is important for the hospital or organization that employs this equipment to carry out a reasonable
service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

II
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.
Customer Service Department
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:
Mindray Building, Keji 12th Road South, High-tech industrial park,
Nanshan, Shenzhen, 518057,P.R.China
Website: www.mindray.com
E-mail Address: [email protected]
Tel:
[phone]
Fax: [phone]
Manufacturer: Mindray DS USA, Inc.
Address: 800 MacArthur Blvd.
Mahwah, NJ 07430-0619 USA
Tel: [phone]
Toll Free:
[phone]
Fax: [phone]

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. The physician is
responsible for the results of 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 also be
continuously alert to dangers other than those indicated. Mindray shall not be liable for damage or
loss resulting from negligence or ignorance of the precautions and operating instructions described in
this operator’s manual.
10. If a new manager takes over this system, be sure to hand over this operator’s manual to the new
manager.
11. According to the conclusion of clinical evaluation and residual risk evaluation, for the intended
patients, there is no known side effects that can occur during or after the use of the medical device.
And there is no need for the operator to make extra preparations. Thus, no residual risk associated
with using the medical device should be disclosed.
About This Manual
This operator’s manual describes the operating procedures for this diagnostic ultrasound system and
the compatible probes. To ensure safe and correct operation, carefully read and understand the manual
before operating the system.
Notation Conventions
In this operator’s manual, the following words are used besides the safety precautions (see “Safety
Precautions”). Please read this operator’s manual before using the system.
NOTE:
Indicates information of interest to users of this system regarding exceptional conditions or
operating procedures.

IV
CAUTION:
The diagnostic ultrasound system is not intended for
ophthalmic use. Its use in this clinical specialty is
contraindicated.
U.S.A. Federal Law restricts this device to sale by or on the
order of a physician.
Operator’s Manuals
You may receive multi-language manuals on compact disc or paper. Please refer to the English manual
for the latest information and registration information.
The content of the operator manual, such as screens, menus or descriptions, may be different from
what you see in your system. The content varies depending on the software version, options and
configuration of the system.
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]
Operator’s Manual [Acoustic Power Data and Surface Temperature Data]
Contains data tables of acoustic output for transducers.
Operation NOTE
Contains a quick guide for basic system operations.
NOTE: Manuals on CD are the manuals translated into languages other than English, according
to the English manuals.
If you find that the contents of the manuals on CD are NOT consistent with the system or
the English manuals, refer ONLY to the corresponding English manuals.
The accompanying manuals may vary depending on the specific system you purchased.
Please refer to the packing list.
Software Interfaces in this Manual
Depending on the software version, preset settings and optional configuration, the actual interfaces
may be different from those in this manual.

V
Conventions
In this manual, the following conventions are used to describe the buttons on the control panel, items in
the menus, buttons in the dialog boxes and some basic operations:
<Buttons>: angular brackets indicate buttons, knobs and other controls on the control panel or
on the keyboard.
[Items in menu or buttons in dialog box]: square brackets indicate items in menus, on the soft
menu or buttons in dialog boxes.
Click [Items or Buttons]: move the cursor to the item or button and press <Set> or use the soft
key corresponding to the soft menu.
[Items in menu][Items in submenu]: select a submenu item following the path.
Notification of Adverse Events
As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY
BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the Member state
in which the user and / or patient is established.
These events, include device-related death and serious injury or illness. In addition, as part of our
Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
requests to be notified of device failures or malfunctions. This information is required to ensure that
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only the highest quality
products.
Product Differences
Model
B-Hist
(Ellipse
)
B-Hist
(Trace
)
B-Hist
(Spline
)
B-Hist
(Rectangle
)
Profil
e
Spline
Lengt
h
Color
Vel Cross Doubl e dist
Reson
a I9 √√√√√√√√√
Reson
a I9
Exp
√× √√√√√√√
Reson
a I9S √√√√√√× √√
Reson
a I9T × √√√√√× √√
Reson
a I9
Easi
√√√√√√× × √
Reson
a I9
Nasa
× √√√√√× × √
Reson
a IV × √√√× √× √√
Imagyn
I9 √√√√√√√× √

VI
Model
B-Hist
(Ellipse
)
B-Hist
(Trace
)
B-Hist
(Spline
)
B-Hist
(Rectangle
)
Profil
e
Spline
Lengt
h
Color
Vel Cross Doubl e dist
Imagyn
I9S √√√√√√√√×
Imagyn
I9 Easi √× √√√√× × √
Nuewa
I9 × × √√√√√× √
Nuewa
I9S √√√√× √√√×
Nuewa
I9 Easi √√√× √√× × √
Nuewa
I9T × × √√√√√√×
Nuewa
I9 Exp × √√× √√√× √
Anesus
I9 × √× √√√√√√
Anesus
I9 Easi × √√× √√× × √
Eagus
I9 × × √√√√√√√
Reson
a I9W √×√√√√√×√
Recho
R9W √√√√√××√√
Recho
R9 ×√√√√××√√
Recho
R9 Pro √×√√√××√√
Recho
R9 Exp √√×√√××√√
Recho
R9S √√√×√××√√
Recho
R9T √√√√×××√√
Recho
R9
Super
××√√√××√√

Safety Precautions 1-1
1 Safety Precautions
1.1 Safety Classification
According to the type of protection against electric shock:
CLASS I EQUIPMENT + INTERNALLY POWERED EQUIPMENT
According to the degree of protection against electric shock:
TYPE-BF APPLIED PART
According to the degree of protection against harmful ingress of water or particulate matter:
The main unit is classified as IPX0
The probe is classified as IPX7
The 2-pedal or 3-pedal footswitch (can be used in the operating room) is classified as IPX8
The 1-pedal footswitch (can be used in the operating room) is classified as IPX8
According to the disinfection and sterilization method(s) recommended by manufacturer:
The devices recommended by the manufacturer.
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
The device equipped with the applied part of defibrillation protection:
The device is not equipped with the applied part of defibrillation protection.
According to the signal input and output parts of the device:
The device is equipped with signal input and output parts
Permanently installed or non-permanently installed:
Non-permanently installed

1-2 Safety Precautions
1.2 Meaning of Signal Words
In this manual, the signal words DANGER, WARNING, CAUTION, NOTE and
Tip are used regarding safety and other important instructions. The signal words and their meanings are
defined as follows. Please understand their meanings clearly before reading this manual.
Signal word Meaning
DANGER
Indicates an imminently hazardous situation that, if not avoided, will result in
death or serious injury.
WARNING
Indicates a potentially hazardous situation that, if not avoided, could result in
death or serious injury.
CAUTION
Indicates a potentially hazardous situation that, if not avoided, may result in
minor or moderate injury.
NOTE Indicates a potentially hazardous situation that, if not avoided, may result in
property damage.
Description Important information that helps you to use the system more effectively.
1.3 Meaning of Safety Symbols
Symbol Description
Type-BF applied part
The ultrasound probes connected to this system are type-BF applied parts.
The ECG leads within this system is type-BF applied part.
Caution!
General warning sign.
Patient injury or tissue damage from ultrasonic radiation. The ALARA
principle must be practiced when operating the ultrasound system.

Safety Precautions 1-3
1.4 Safety Precautions
Please observe the following precautions to ensure patient and operator’s safety when using this
system.
DANGER:
Do not operate this system and probes in an atmosphere containing
flammable gasses or liquids such as anesthetic gasses, hydrogen, and
ethanol, because there is danger of explosion.
WARNING:
1. Do connect the power plug of this system to wall receptacles
that meet the ratings indicated on the rating nameplate. If
adapters or multifunctional receptacles are used, it may cause
the leakage current to exceed the safety requirement.
2. In the environment that patient is 1.5 meters around, connect
peripherals to the auxiliary power outlet which is capable of
isolation protection, or power the peripherals by auxiliary output
cable or isolation transformer complied with IEC60601-1 or the
power input of the same safety level.
3. DO NOT use power supply of different phases to power
peripherals, like power supply of air-conditioning.
4. When using peripherals not powered by the auxiliary output of
the ultrasound system, or using peripherals other than permitted
by Mindray, make sure the overall leakage current of peripherals
and the ultrasound system meets the requirement of the local
medical device electrical regulation (like enclosure leakage
current should be no more than 500uA of IEC60601-1), and the
responsibility is held by the user.
5.
Connect the grounding conductor before turning ON the system.
Disconnect the grounding cable after turning OFF the system.
Otherwise, electric shock may result.
6.
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.
7. Before cleaning the system, disconnect the power cord from the
outlet. System failure and electric shock may result.
8. This system is not water-proof designed. Do Not use this system
in any place where water or any liquid leakage may occur. If any
water is sprayed on or into the system, electric shock may result
or the system may be damaged. If water is accidentally sprayed
on or into the system, contact Mindray Customer Service
Department or sales representative.
9. DO NOT use a probe that has a damaged, scratched surface, or
exposed wiring of any kind. Immediately stop using the probe
and contact Mindray Customer Service Department or sales
representative. There is risk of electric shock if using a damaged
or scratched transducer.

1-4 Safety Precautions
10.
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.
11.
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.
12.
Do not subject the transducers to knocks or drops. Use of a
defective transducer may cause an electric shock.
13. 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.
14. Do not use the system with the patient when the system is being
serviced or maintained.
15. Do not use this system when any digital device such as a high-
frequency electrotome, high-frequency therapeutic device or
defibrillator is applied already. Otherwise, there is a risk of
electric shock to the patient.
16.
Only use the ECG leads provided with the physiology module;
otherwise, electric shock may be resulted.
17. When moving the system, you should hold the handle;
otherwise, damage may be resulted by abnormal force. Do not
push the system from the left/right side, otherwise, it may be
toppled over.
18.
The auxiliary power output outlet in the system is used to supply
power for the recommended peripheral devices. Do not connect
other devices to the outlet, otherwise, the rated output power
may be exceeded and failure may be resulted.
19. Accessory equipment (analog or digital) connected to the
ultrasound system must comply with the relevant IEC standards
(e.g., IEC 60950 information technology equipment safety
standard and IEC 60601-1 medical equipment standard).
Furthermore, all configurations must comply with the standard
IEC60601-1. It is the responsibility of the person, who connects
additional equipment to the signal input or output ports and
configures a medical system, to verify that the system complies
with the requirements of IEC60601-1. If you have any questions
regarding these requirements, consult your vendor.
20.
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.
21.
It is not allowed for the operator to have contact with other
patients and the electronic parts (such as the input/output
terminal of the signal) of other devices that are connected to the
system. Otherwise, it may produce the electrical shock to the
patient.
22. When using a probe, pay attention to the status of the ultrasound
image. Do not use the probe to perform image acquisition when the
image is frozen.

Safety Precautions 1-5
23. To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
Caution:
1.
Precautions concerning clinical examination techniques:
This system must be used only by qualified medical professionals.
This operator’s manual does not describe clinical examination
techniques. The clinician should select the proper examination
techniques based on specialized training and clinical experience.
2. Malfunctions due to radio wave:
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:
Please install the system on a flat plane with casters locked. Otherwise,
damage may be resulted by accidental moving.
Do not move the system laterally, which may result in damage in case
of toppling.
Move the system slowly on the slope by two people, otherwise,
damage may result in case of unexpected sliding.
Do not sit on the system, which may result individual falling in case of
system moving.
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.
When moving the system on the steps, please take care to prevent the
system from toppling.
4.
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.
5. There is no risk of high-temperature burns during normal ultrasound
examinations. It is possible for the surface temperature of the transducer
to exceed the body temperature of a patient due to environmental
temperature and exam type combinations. Do not apply the transducer to
the same region on the patient for a long time. Apply the transducer only
for a period of time required for the purpose of diagnosis.
6. Do not use the system to examine a fetus for a long period of time.
7. Except accessories that have been stated as sterile, the system and its
accessories are not disinfected or sterilized prior to delivery. The operator
is responsible for the cleaning and disinfection of probes and sterilization
of biopsy brackets according to the manuals, prior to the use. All items
must be thoroughly processed to completely remove harmful residual
chemicals, which will not only harmful to the human body, but also
damage the accessory.
8. It is necessary to press [End] 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.

1-6 Safety Precautions
9. Do not connect or disconnect the system’s power cord or its accessories
(e.g., a printer or a recorder) without turning OFF the system power first.
This may damage the system and its accessories or cause electric shock.
10.
If the system is powered off improperly during operation, it may result in
data damage of the system’s hard disk or system failure.
11.
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.
12.
It is recommended to only use the video devices specified in this manual.
13.
Do not use gel, disinfectant, probes, probe sheath or needle-guided
brackets that are not compatible with the system.
14.
The applied contrast agency should be compliant with the relevant local
regulations.
15.
Read the Acoustic Output Principle in the operation manual carefully
before operating this system on clinical examination.
16.
The cover contains natural rubber that can cause allergic reactions in
some individuals.
17.
Please use the ultrasound gel compliant with the relevant local
regulations.
18.
Normal operation may be affected by unstable mains power supply; it is
recommended that our product be powered from an uninterruptible power
supply.
19.
DO NOT expose the system to excessive vibration through transportation.
Mechanical damage may result.
20.
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.
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 (e.g.
cellular phones), which may affect the performance of the system or even lead to
failure.
3. When using or placing the system, keep the system horizontal to avoid
imbalance.
4. To avoid damaging the system, do not use it in following environment:
Locations exposed to direct sunlight;
Locations subject to sudden changes in environmental temperature;
Dusty locations;
Locations subject to vibration;
Locations near heat generators;

Locations with high humidity.
5. 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.
6. Press <Freeze> key to freeze an image or turn off the power of the system before
connecting or disconnecting a probe.

Safety Precautions 1-7
7. Remove the ultrasound gel from the face of the transducer when the examination
is completed. Water in the gel may enter the acoustic lens and adversely affect
the performance and safety of the transducer.
8. 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.
9. Do not apply external force to the control panel. Otherwise, the system may be
damaged.
10.
If the system is used in a small room, the room temperature may rise. Please
provide proper ventilation and free air exchange.
11. 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. Mindray is not
responsible for any system content or accessories that have been discarded
improperly.
12. 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.
13. The replaceable fuse is inside the chassis. Refer replacing job to Mindray service
engineers or engineers authorized by Mindray only.
14.
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.
15. The iScape View 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 View image.
16. Ensure that the current exam date and time are the same as the system date and
time.
17. Use the pluggable power supply as the net power supply breaking facility.
Please read the following precautions carefully to ensure the safety of the patient and the operator
when using the probes.
WARNING:
1. The ultrasonic probe is only for use with the specified ultrasonic
diagnostic system. See Chapter 2.4.2 Probes and Needle-guided
Brackets Available for details.
2. The ultrasonic probe must be used only by qualified professionals.
3. Confirm that the transducer and probe cable are normal before and
after each examination. A defective probe may cause electric shock
to the patient.
4. Do not subject the probe to shock. A defective probe may cause
electric shock to the patient.
5. Do not disassemble the probe to avoid the possibility of electric
shock.
6.
Never immerse the probe connector into liquids such as water or
disinfectant because the connector is not waterproof. Immersion
may cause electric shock or malfunction.

1-8 Safety Precautions
7.
A transducer sheath must be installed over the transducer before
performing examination.
Caution:
1. When using the probe, wear sterile gloves to prevent infection.
2. Be sure to use sterile ultrasound gel. Please use the ultrasound gel
compliant with the relevant local regulations. And manage the ultrasound gel
properly to ensure that it does not become a source of infection.
3. In normal diagnostic ultrasound mode, there is no danger of a normal-
temperature burn; however, keeping the probe on the same region of the
patient for a long time may cause such a burn.
4. Do not use the carrying case for storing the transducer. If the carrying case
is used for storage, it may become a source of infection.
5. It is required to practice ALARA when operating ultrasound system. Minimize
the acoustic power without compromising the quality of images.
6. The probe and accessories supplied with it are not delivered disinfected or
sterilized. Sterilization (or high-level disinfect) before use is required.
7.
Disposable components should be packaged sterile and for single-use only.
Do not use if integrity of packaging violated or if expiration date has passed.
Please use the disposable components compliant with the relevant local
regulations.
8. Please use the disinfection or sterilization solution recommended in this
operator’s manual; otherwise Mindray will not be liable for damage caused
by other solutions. If you have any questions, please contact Mindray
Customer Service Department or sales representative.
9. Do not use pre-lubricated condoms as a sheath. Lubricant may not be
compatible with the probe material and damage may result.
10.
The damage of the transducer may be caused by the contact of improper gel
or cleaner:
DO NOT dip the transducer in the strong polar solution of ethanol,
chloride of lime, ammonium chloride, acetone and formaldehyde.
DO NOT contact the transducer with solution or ultrasound gel
containing oily medium such as mineral oil or lanoline.
NOTE: Read the following precautions to prevent probe malfunction:
Before connecting or disconnecting the probe, freeze or turn off the diagnostic
ultrasound system.
Clean and disinfect the probe before and after each examination.
After an examination, wipe the ultrasound gel off thoroughly. Failure to do so may
result in the ultrasound gel solidifying and the image quality being degraded.
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