Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-N2 User manual
DC-N2/DC-N2T/DC-N2S
Diagnostic Ultrasound System
Operator’s Manual
[Basic Volume]
i
Contents
Intellectual Property Statement .......................................................................................................... I
Responsibility on the Manufacturer Party .......................................................................................... I
Warranty ............................................................................................................................................ II
Exemptions................................................................................................................................... II
Customer Service Department..................................................................................................... II
Important Information ....................................................................................................................... III
About This Manual ........................................................................................................................... III
Notation Conventions ....................................................................................................................... III
Operator’s Manuals..........................................................................................................................IV
Manuals on Paper ............................................................................................................................ IV
Software Interfaces in this Manual ....................................................................................................V
Conventions ......................................................................................................................................V
Product Differences......................................................................................................................V
1Safety Precautions ..................................................................................................... 1-1
1.1Safety Classification ............................................................................................................. 1-1
1.2Meaning of Signal Words ..................................................................................................... 1-2
1.3Meaning of Safety Symbols ................................................................................................. 1-2
1.4Safety Precautions ............................................................................................................... 1-3
1.5Latex Alert .......................................................................................................................... 1-10
1.6Warning Labels .................................................................................................................. 1-11
2System Overview ........................................................................................................ 2-1
2.1Intended Use ........................................................................................................................ 2-1
2.2Contraindication ................................................................................................................... 2-1
2.3Product and Model Code ..................................................................................................... 2-1
2.4Product Specifications.......................................................................................................... 2-1
2.4.1Imaging Mode ............................................................................................................... 2-1
2.4.2Power supply ................................................................................................................ 2-1
2.4.3Environmental Conditions............................................................................................. 2-2
2.4.4Size and weights........................................................................................................... 2-2
2.5System Configuration........................................................................................................... 2-2
2.5.1Standard Configuration................................................................................................. 2-2
2.5.2Transducers Available .................................................................................................. 2-3
2.5.3Options ......................................................................................................................... 2-4
2.5.4Peripherals Supported.................................................................................................. 2-5
2.6Introduction of Each Unit...................................................................................................... 2-6
2.6.1I/O Panel....................................................................................................................... 2-7
2.6.2Power Supply Panel ..................................................................................................... 2-8
2.6.3Control Panel ................................................................................................................ 2-9
2.7Symbols.............................................................................................................................. 2-12
3System Preparation .................................................................................................... 3-1
3.1Move/Posit the System ........................................................................................................ 3-1
3.2Power Supply ....................................................................................................................... 3-1
3.2.1Connecting External Power Supply .............................................................................. 3-1
3.2.2Equipotential Terminal .................................................................................................. 3-3
3.2.3Powered by Battery ...................................................................................................... 3-3
3.3Powering ON/ OFF............................................................................................................... 3-4
3.3.1Powering ON ................................................................................................................ 3-4
ii
3.3.2Powering OFF............................................................................................................... 3-6
3.4Display Adjusting .................................................................................................................. 3-6
3.4.1Position ......................................................................................................................... 3-6
3.4.2Tilting Angle .................................................................................................................. 3-6
3.4.3Brightness and Contrast ............................................................................................... 3-7
3.5Connecting / Disconnecting a Probe.................................................................................... 3-7
3.5.1Connecting a Probe ...................................................................................................... 3-7
3.5.2Disconnecting a Probe ................................................................................................. 3-8
3.6Connecting the Footswitch................................................................................................... 3-8
3.7Connecting/ Removing a USB Storage Device.................................................................... 3-8
3.8Graph / Text Printer .............................................................................................................. 3-9
3.8.1Connecting a Local Printer ........................................................................................... 3-9
3.8.2Add Network Printer.................................................................................................... 3-11
3.8.3Add Shared Printer ..................................................................................................... 3-11
3.8.4iStorage UltraAssist Print............................................................................................ 3-12
3.8.5Print Service ............................................................................................................... 3-12
3.9Digital Video Printer............................................................................................................ 3-12
3.10Analog Video Printer .......................................................................................................... 3-13
3.11Basic Screen and Operation .............................................................................................. 3-14
3.11.1Basic Screen............................................................................................................... 3-14
3.11.2Basic Operations of Screens ...................................................................................... 3-17
4Exam Preparation ....................................................................................................... 4-1
4.1Start an Exam....................................................................................................................... 4-1
4.2Patient Information ............................................................................................................... 4-1
4.2.1New Patient Information ............................................................................................... 4-1
4.2.2Retrieve Patient Information ......................................................................................... 4-5
4.3Select Exam Mode and Probe ............................................................................................. 4-7
4.3.1Selecting Exam Mode and Probe ................................................................................. 4-7
4.4Selecting Imaging Mode....................................................................................................... 4-8
4.5Activate& Continue an Exam ............................................................................................... 4-8
4.5.1Activate an Exam.......................................................................................................... 4-8
4.5.2Continue an Exam ........................................................................................................ 4-8
4.6Pause & End an Exam ......................................................................................................... 4-8
4.6.1Pause and Exam .......................................................................................................... 4-8
4.6.2End an Exam ................................................................................................................ 4-9
5Image Optimization..................................................................................................... 5-1
5.1Switching Among Imaging Modes ........................................................................................ 5-1
5.2Basic Operations .................................................................................................................. 5-2
5.3Quickly Saving Image Setting (QSave)................................................................................ 5-4
5.4B Mode ................................................................................................................................. 5-5
5.4.1B Mode Exam Protocol................................................................................................. 5-5
5.4.2B Mode Parameters...................................................................................................... 5-5
5.4.3B Mode Image Optimization ......................................................................................... 5-5
5.5M Mode .............................................................................................................................. 5-10
5.5.1M Mode Exam Protocol .............................................................................................. 5-10
5.5.2M Mode Parameters ................................................................................................... 5-10
5.5.3M Mode Image Optimization....................................................................................... 5-10
5.6Color Mode Image Optimization......................................................................................... 5-12
5.6.1Color Mode Exam Protocol......................................................................................... 5-12
5.6.2Color Mode Image Optimization................................................................................. 5-12
iii
5.6.3Color Mode Image Optimization................................................................................. 5-12
5.7Power Mode Image Optimization ....................................................................................... 5-16
5.7.1Basic Procedures for Power Mode Imaging ............................................................... 5-16
5.7.2Power Mode Image Parameters................................................................................. 5-16
5.7.3Power Mode Image Optimization ............................................................................... 5-16
5.8PW Doppler Mode .............................................................................................................. 5-17
5.8.1Basic Procedures for PW Mode Exam ....................................................................... 5-17
5.8.2PW Mode Image Parameters ..................................................................................... 5-18
5.8.3PW Mode Image Optimization.................................................................................... 5-18
5.9iScape ................................................................................................................................ 5-22
5.9.1Basic Procedures for iScape Imaging ........................................................................ 5-22
5.9.2Image Acquisition........................................................................................................ 5-23
5.9.3iScape Viewing ........................................................................................................... 5-24
5.9.4Cine Review................................................................................................................ 5-25
5.10Smart 3D ............................................................................................................................ 5-26
5.10.1Note before Use.......................................................................................................... 5-26
5.10.2Overview..................................................................................................................... 5-27
5.10.3Basic Procedures for Smart 3D Imaging .................................................................... 5-30
5.10.4Smart 3D Acquisition Preparation............................................................................... 5-31
5.10.5Smart 3D Image Viewing ............................................................................................ 5-33
5.10.6Image Saving and Reviewing in Smart 3D................................................................. 5-39
6Display & Cine Review ............................................................................................... 6-1
6.1Image Display....................................................................................................................... 6-1
6.1.1Splitting Display ............................................................................................................ 6-1
6.1.2Image Magnification ..................................................................................................... 6-1
6.1.3Freeze/ Unfreeze the Image......................................................................................... 6-2
6.2Cine Review ......................................................................................................................... 6-3
6.2.1Entering/ Exiting Cine Review ...................................................................................... 6-3
6.2.2Cine Review in 2D Mode .............................................................................................. 6-3
6.2.3Cine Review in M/ PW Mode........................................................................................ 6-4
6.2.4Linked Cine Review ...................................................................................................... 6-5
6.3Image Compare.................................................................................................................... 6-5
6.3.1Image Compare in Review Mode ................................................................................. 6-5
6.3.2Frame Compare............................................................................................................ 6-6
6.4Cine Memory ........................................................................................................................ 6-7
6.4.1Cine Memory Setting .................................................................................................... 6-7
6.4.2Cine Memory Clear....................................................................................................... 6-7
6.5Preset ................................................................................................................................... 6-8
7Measurement............................................................................................................... 7-1
7.1Basic Operations .................................................................................................................. 7-1
7.2General Measurements........................................................................................................ 7-1
7.2.12D General Measurements .......................................................................................... 7-1
7.2.2M General Measurements ............................................................................................ 7-2
7.2.3Doppler General Measurements .................................................................................. 7-2
7.3Application Measurement..................................................................................................... 7-3
7.4Measurement Accuracy........................................................................................................ 7-4
8Comments and Body Marks ...................................................................................... 8-1
8.1Comments ............................................................................................................................ 8-1
8.1.1Comment Basic Procedures......................................................................................... 8-1
8.1.2Comment Menu ............................................................................................................ 8-1
iv
8.1.3Adding Comments ........................................................................................................ 8-3
8.1.4Moving Comments........................................................................................................ 8-4
8.1.5Editing Comments ........................................................................................................ 8-4
8.1.6Deleting Comments ...................................................................................................... 8-4
8.2Body Mark ............................................................................................................................ 8-5
8.2.1Body Mark Operation Procedures ................................................................................ 8-5
8.2.2Menu............................................................................................................................. 8-5
8.2.3Adding Body Marks....................................................................................................... 8-5
8.2.4Moving Body Marks ...................................................................................................... 8-5
8.2.5Deleting Body Marks..................................................................................................... 8-6
9Patient Data Management .......................................................................................... 9-1
9.1Patient Information Management ......................................................................................... 9-1
9.1.1Enter Patient Information.............................................................................................. 9-1
9.2Image File Management ...................................................................................................... 9-1
9.2.1Storage Media............................................................................................................... 9-1
9.2.2Image File Formats....................................................................................................... 9-1
9.2.3Image Storage Preset................................................................................................... 9-2
9.2.4Saving Images to the System....................................................................................... 9-2
9.2.5Quickly Saving Images to USB Flash Drive ................................................................. 9-3
9.2.6Quickly Saving Full Screen Image to the System ........................................................ 9-3
9.2.7Thumbnails ................................................................................................................... 9-3
9.2.8Image Review and Analysis.......................................................................................... 9-3
9.2.9iVision ........................................................................................................................... 9-5
9.2.10Sending Image File....................................................................................................... 9-7
9.3Report Management............................................................................................................. 9-7
9.4Patient Data Management (iStation) .................................................................................... 9-8
9.4.1Searching a Patient ...................................................................................................... 9-9
9.4.2Patient Data View & Management.............................................................................. 9-10
9.5Backing Up and Erasing Files through DVD Drive............................................................. 9-12
9.6Patient Task Manager......................................................................................................... 9-13
9.7Access Control ................................................................................................................... 9-14
9.7.1Access Setting ............................................................................................................ 9-14
9.7.2Setting Access Control ............................................................................................... 9-14
9.7.3System Login .............................................................................................................. 9-14
9.7.4Add/ Delete a User ..................................................................................................... 9-15
9.7.5Modify Password ........................................................................................................ 9-17
10DICOM........................................................................................................................ 10-1
10.1DICOM Preset .................................................................................................................... 10-2
10.1.1Network Preset ........................................................................................................... 10-2
10.1.2DICOM Preset ............................................................................................................ 10-3
10.1.3DICOM Service........................................................................................................... 10-4
10.2Verify Connectivity.............................................................................................................. 10-9
10.3DICOM Service .................................................................................................................. 10-9
10.3.1DICOM Storage .......................................................................................................... 10-9
10.3.2DICOM Print ............................................................................................................. 10-10
10.3.3DICOM Worklist ........................................................................................................ 10-11
10.3.4MPPS........................................................................................................................ 10-13
10.3.5Storage Commitment................................................................................................ 10-13
10.3.6Query/Retrieve.......................................................................................................... 10-14
10.4DICOM Media Storage ..................................................................................................... 10-15
v
10.5Structured Report ............................................................................................................. 10-16
10.6DICOM Task Manager...................................................................................................... 10-16
11Setup...........................................................................................................................11-1
11.1System Preset .................................................................................................................... 11-1
11.1.1Region ........................................................................................................................ 11-2
11.1.2General ....................................................................................................................... 11-2
11.1.3Image Preset .............................................................................................................. 11-4
11.1.4Application .................................................................................................................. 11-5
11.1.5OB............................................................................................................................... 11-5
11.1.6Key Configuration (Key Config) .................................................................................. 11-5
11.1.7Admin.......................................................................................................................... 11-6
11.2Exam Preset....................................................................................................................... 11-6
11.3Measure Preset .................................................................................................................. 11-7
11.4Print Preset......................................................................................................................... 11-7
11.5Network Preset................................................................................................................... 11-8
11.6Maintenance....................................................................................................................... 11-9
11.7System Information ............................................................................................................ 11-9
12Probes and Biopsy ................................................................................................... 12-1
12.1Probe.................................................................................................................................. 12-1
12.1.1Probe Functions by Part ............................................................................................. 12-2
12.1.2Orientation of the Ultrasound Image and the Transducer Head................................. 12-3
12.1.3Operating Procedures ................................................................................................ 12-4
12.1.4Wearing the Transducer Sheath................................................................................. 12-6
12.1.5Probes Cleaning and Disinfection .............................................................................. 12-7
12.1.6Storage and Transportation ...................................................................................... 12-10
12.2Biopsy Guide .................................................................................................................... 12-11
12.2.1Basic Procedures for Biopsy Guiding ....................................................................... 12-13
12.2.2Needle-guided Brackets ........................................................................................... 12-14
12.2.3Needle-guided Bracket Inspection and Installation .................................................. 12-16
12.2.4Biopsy Menu ............................................................................................................. 12-19
12.2.5Verify Biopsy Guide Line........................................................................................... 12-20
12.2.6Removing the Needle-guided Bracket...................................................................... 12-21
12.2.7Clean and Sterilize the Needle-guided Bracket........................................................ 12-23
12.2.8Storage and Transportation ...................................................................................... 12-24
12.2.9Disposal .................................................................................................................... 12-24
12.3Lithotrity............................................................................................................................ 12-24
13Battery ....................................................................................................................... 13-1
13.1Overview ............................................................................................................................ 13-1
13.2Precautions ........................................................................................................................ 13-1
13.3Battery Status Indicator ...................................................................................................... 13-1
13.4One Full Discharge / Charge Cycle.................................................................................... 13-2
13.5Checking Battery Performance .......................................................................................... 13-2
13.6Battery Disposal ................................................................................................................. 13-2
14Acoustic Output........................................................................................................ 14-1
14.1Concerns with Bioeffects.................................................................................................... 14-1
14.2Prudent Use Statement ...................................................................................................... 14-1
14.3ALARA Principle (As Low As Reasonably Achievable) ...................................................... 14-1
14.4MI/TI Explanation ............................................................................................................... 14-2
14.4.1Basic Knowledge of MI and TI.................................................................................... 14-2
vi
14.4.2MI/TI Display............................................................................................................... 14-2
14.5Acoustic Power Setting ...................................................................................................... 14-3
14.6Acoustic Power Control...................................................................................................... 14-3
14.7Acoustic Output .................................................................................................................. 14-4
14.7.1Derated Ultrasonic Output Parameters ...................................................................... 14-4
14.7.2Limits of Acoustic Output ............................................................................................ 14-4
14.7.3Differences between Actual and Displayed MI and TI................................................ 14-5
14.8Measurement Uncertainty .................................................................................................. 14-5
14.9References for Acoustic Power and Safety........................................................................ 14-6
15Guidance and Manufacturer’s Declaration............................................................. 15-1
16System Maintenance ................................................................................................ 16-1
16.1Daily Maintenance.............................................................................................................. 16-1
16.1.1Cleaning the System .................................................................................................. 16-1
16.1.2Checking the Transducer............................................................................................ 16-4
16.1.3Checking the Power Cable and Plug.......................................................................... 16-4
16.1.4Checking the Circuit Breaker...................................................................................... 16-4
16.1.5Checking Appearance ................................................................................................ 16-4
16.1.6Backup of the System Hard Drive .............................................................................. 16-5
16.2Troubleshooting.................................................................................................................. 16-6
Appendix AiScanHelper ............................................................................................A-1
Appendix BElectrical Safety Inspection ..................................................................B-1
I
©2013-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2014-04.
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.
Note
This equipment must be operated by skilled/trained clinical professionals.
Warning
II
It is important for the hospital or organization that employs this equipment to carry out a
reasonable service/maintenance plan. Neglect of this may result in machine breakdown or
personal injury.
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
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
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: service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680
III
Important Information
1. It is the customer’s responsibility to maintain and manage the system after delivery.
2. The warranty does not cover the following items, even during the warranty period:
(1) Damage or loss due to misuse or abuse.
(2) Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning,
etc.
(3) Damage or loss caused by failure to meet the specified conditions for this system,
such as inadequate power supply, improper installation or environmental conditions.
(4) Damage or loss due to use of the system outside the region where the system was
originally sold.
(5) Damage or loss involving the system purchased from a source other than Mindray or
its authorized agents.
3. This system shall not be used by persons other than fully qualified and certified medical
personnel.
4. Do not make changes or modifications to the software or hardware of this system.
5. In no event shall Mindray be liable for problems, damage, or loss caused by relocation,
modification, or repair performed by personnel other than those designated by Mindray.
6. The purpose of this system is to provide physicians with data for clinical diagnosis. It is
the physician’s responsibility for diagnostic procedures. Mindray shall not be liable for the
results of diagnostic procedures.
7. Important data must be backed up on external memory media.
8. Mindray shall not be liable for loss of data stored in the memory of this system caused by
operator error or accidents.
9. This manual contains warnings regarding foreseeable potential dangers, but you shall
always be alert to dangers other than those indicated as well. Mindray shall not be liable
for damage or loss that results from negligence or from ignoring the precautions and
operating instructions described in this operator’s manual.
10. If the manager for this system is changed, be sure to hand over this operator’s manual to
the new manager.
About This Manual
This operator’s manual describes the operating procedures for this diagnostic ultrasound
system DC-N2/DC-N2T/DC-N2S and the compatible probes. To ensure safe and correct
operations, 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 (refer
to "Safety Precautions"). Please read this operator’s manual before using the system.
CAUTION: The diagnostic ultrasound system is not intended for ophthalmic
use. Its use in this clinical specialty is contraindicated.
IV
Operator’s Manuals
Please read the operator’s manuals carefully before operating the system.
You may receive multi-language manuals in compact disc or paper. Please refer to English
manual for latest information and register information.
The content of the operator manual, such as screens, menus or descriptions, may be different
from what you see in your system. The content varies depending upon the software version,
options and configuration of the system.
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.
NOTE: 1. The manuals in CD are the manuals translated into languages other than
English according to English manuals.
2. When you find that the contents of the manuals in CD are NOT consistent with
the system or English manuals, please ONLY refer to the corresponding English
manuals.
3. The accompanying manuals may vary depending upon the specific system you
purchased. Please refer to the packing list.
V
Software Interfaces in this Manual
Depending on the software version, preset settings and optional configuration, the actual
interfaces may be different from those in this manual.
Conventions
In this manual, these conventions are used to describe the buttons on the control panel, the
items in menu, buttons in dialog box and some basic operations:
z<Buttons>: The angular bracket indicates buttons, knobs and other controls on
control panel.
z[Items in menu and buttons in dialog box]: The square bracket indicates items in
menu or buttons in dialog box.
zClick [Items or Button]: Move the cursor to the item or button and press <Set>, or
click it on the menu.
z[Items in Menu]Æ[Items in Submenu]: Selects a submenu item following the path.
z[Dyn Rng (Value)]: Indicates menu items with parameter, (value) shows the current
value of the item.
Product Differences
Product Model B-histogram B-Profile
DC-N2 √√
DC-N2T √×
DC-N2S × √
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 ME 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:
Main unit: IPX0
Probes: IPX7
Footswitch: 1-pedal type belongs to IPX8, 2-pedal and 3-pedal type belong to IP68.
According to the degree of safety of application in the presence of a FLAMMABLE
ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE:
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC
MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE
According to the mode of operation:
CONTINUOUS OPERATION
According to the installation and use:
MOBILE EQUIPMENT
1-2 Safety Precautions
1.2 Meaning of Signal Words
In this manual, the signal words" DANGER”, “ WARNING”, “ CAUTION”,
“NOTE” and "Tips" are used regarding safety and other important instructions. The signal
words and their meanings are defined as follows. Please understand their meanings clearly
before reading this manual.
Signal word Meaning
DANGER Indicates an imminently hazardous situation that, if not avoided, will result
in death or serious injury.
WARNING Indicates a potentially hazardous situation that, if not avoided, could result
in death or serious injury.
CAUTION Indicates a potentially hazardous situation that, if not avoided, may result
in minor or moderate injury.
NOTE Indicates a potentially hazardous situation that, if not avoided, may result in
property damage.
Tips Important information that helps you to operate the system more effectively.
1.3 Meaning of Safety Symbols
Symbol Description
Type-BF applied part.
The ultrasound probes connected to this system are type-BF applied parts.
General warning, caution, risk of danger.
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.
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 use flammable gasses, such as anesthetic gas or
hydrogen, or flammable liquids such as ethanol, near this
system, because there is danger of explosion.
WARNING: 1. Do connect the power plug of this system and power plugs
of the peripherals to wall receptacles that meet the ratings
indicated on the rating nameplate. Using a multifunctional
receptacle may affect the system protective grounding
performance, and cause the leakage current to exceed
safety requirements.
Use the cable provided with this system to connect the
printer. Other cables may result in electric shock.
You must use the power adapter provided with the system;
otherwise electric shock may result.
You can only adopt the power supply method provided by
Mindray, other power supply modes (e.g. using a UPS) may
result in electric shock.
2. Connect the protective grounding conductor before
turning ON the system. Disconnect the grounding cable
after turning OFF the system. Otherwise, electric shock
may result.
3. For the connection of power and grounding, follow the
appropriate procedures described in this operator’s
manual. Otherwise, there is risk of electric shock. DO
NOT connect the grounding cable to a gas pipe or water
pipe; otherwise, improper grounding may result or a gas
explosion may occur.
4. Before cleaning the system, disconnect the power cord
from the outlet. System failure and electric shock may
result.
5. This system is not water-proof designed. Do Not use this
system in any place where water or any liquid leakage
may occur. If any water is sprayed on or into the system,
electric shock or device malfunction may result. If water is
accidentally sprayed on or into the system, contact
Mindray Customer Service Department or sales
representative.
6. 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. There is risk
of electric shock if using a damaged or scratched
transducer.
1-4 Safety Precautions
7. DO NOT allow the patient to contact the live parts of the
ultrasound system or other devices, e.g. signal I / O
ports. Electric shock may occur.
8. Do not use an aftermarket probe other than those
specified by Mindray. The probes may damage the
system causing a profound failure, e.g. a fire in the worst
case.
9. Do not subject the transducers to knocks or drops. Use
of a defective transducer may cause an electric shock.
10. Do not open the covers and front panel of the system.
Short circuit or electric shock may result when the
system hardware is exposed and powered on.
11. Do not use this system 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.
12. 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.
13. 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. Maximum output power of the outlet is 288VA.
14. Accessory equipment connected to the analog and digital
interfaces must comply with the relevant IEC standards
(e.g., IEC 60950 information technology equipment safety
standard and IEC 60601-1 medical equipment
standard).Furthermore, all configurations must comply
with the standard IEC 60601-1-1.It is the responsibility of
the person, who connects additional equipment to the
signal input or output ports and configures a medical
system, to verify that the system complies with the
requirements of IEC 60601-1-1.If you have any questions
regarding these requirements, consult your sales
representative.
15. Prolonged and repeated use of keyboards may result in
hand or arm nerve disorders for some individuals.
Observe the local safety or health regulations concerning
the use of keyboards.
16. When using intra-cavity transducers, do not activate the
transducer outside the patient’s body.
17. DO NOT touch the Signal I/O ports if in contact with the
patient; otherwise patient injury may result.
18. The operator SHOULD NOT touch SIP/SOP and the
patient at the same time.
Safety Precautions 1-5
19. If the battery cannot be automatically maintained in a
fully usable condition, please conduct periodic checking
of the battery.
20. The ultrasound system use a mains plug as isolation
means to the mains power supply. Please do not posite
the ultrasound system in a place difficult to operate the
mains plug.
21. Do not modify this equipment without authorization of
the manufacturer.
CAUTION: 1. Precautions concerning clinical examination techniques:
zThis system must be used only by qualified medical
professionals.
zThis 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:
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 moving the system:
zPlease install the system on a flat plane with casters
locked. Otherwise, damage may be resulted by
accidental moving.
zDo not move the system laterally, which may result in
damage in case of toppling.
zMove the system slowly on the slope by two people,
otherwise, damage may result in case of unexpected
sliding.
zDo not sit on the system, which may result individual
falling in case of system moving.
zObject placed on the monitor may fall and injure an
individual when moving.
zFasten and fully secure any peripheral device before
moving the system. A loose peripheral device may fall
and injure an individual.
When move the system on the steps, please take care to
prevent the system from toppling.
4. DO NOT expose the system to excessive vibration
through transportation. Mechanical damage may result.
1-6 Safety Precautions
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.
8. 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.
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, which
will not only be harmful to the human body, but also
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) without turning OFF the
power first. This may damage the system and its
accessories or cause electric shock.
12. If the system is powered off improperly during operation,
it may result in data damage of the system’s hard disk or
system failure.
13. Do not use the system to examine a fetus for a long period
of time.
14. Do not use a USB memory device (e.g., a USB flash drive,
removable hard disk) which has unsafe data. Otherwise,
system damage may result.
15. It is recommended to only use the video devices specified
in this manual.
This manual suits for next models
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