Mindray DP-10 User manual

DP-10/DP-10T/DP-11/DP-15/DP-18
Digital Ultrasonic Diagnostic Imaging System
Operator’s Manual
[Basic Volume]

i
Contents
Contents ..........................................................................................................i
Intellectual Property Statement ..............................................................................................I
Responsibility on the Manufacturer Party ............................................................................ II
Warranty............................................................................................................................... II
Important Information .......................................................................................................... IV
Preface ................................................................................................................................. V
Safety Precautions ............................................................................................................ VIII
1System Basics.......................................................................................1-1
1.1 Structure ................................................................................................................. 1-1
1.2 I/O Panel ................................................................................................................ 1-3
1.3 Power Supply Panel ............................................................................................... 1-3
1.4 Control Panel.......................................................................................................... 1-4
1.5 Interface Elements and Operations........................................................................ 1-6
1.5.1 Interface................................................................................................................ 1-6
1.5.2 Menu..................................................................................................................... 1-8
1.5.3 Dialog Box .......................................................................................................... 1-10
2System Connection ..............................................................................2-1
2.1 Connecting Power Supply...................................................................................... 2-1
2.2 Connecting Equipotential Terminal......................................................................... 2-1
2.3 Connecting Transducer .......................................................................................... 2-2
2.4 Connecting a Footswitch ........................................................................................ 2-3
2.5 Connecting Peripherals .......................................................................................... 2-3
3Startup/Shutdown .................................................................................3-1
3.1 Startup .................................................................................................................... 3-1
3.2 Shutdown................................................................................................................ 3-2
4Preset.....................................................................................................4-1
5Beginning Exam....................................................................................5-1
5.1 Inputting Patient Information .................................................................................. 5-1
5.2 Selecting Exam Mode ............................................................................................ 5-2
5.3 Selecting Transducer.............................................................................................. 5-2
5.4 Selecting Image Mode............................................................................................ 5-2
5.5 Adjusting M-mark Position...................................................................................... 5-2

ii
6Image Control and Adjustment............................................................6-1
6.1 Adjusting Image Parameters.................................................................................. 6-1
6.2 Image Zoom ........................................................................................................... 6-6
6.3 Image Reverse ....................................................................................................... 6-7
7Cine ........................................................................................................7-1
7.1 Cine Indicator ......................................................................................................... 7-1
7.2 Manual Cine and Auto Cine ................................................................................... 7-1
8Measurements.......................................................................................8-1
8.1 Measurement Menu ............................................................................................... 8-1
8.2 General Procedure of Measurements .................................................................... 8-1
9Comment ...............................................................................................9-1
9.1 Entering Comment Status ...................................................................................... 9-1
9.2 Adding Comments.................................................................................................. 9-1
9.3 Moving Comments ................................................................................................. 9-3
9.4 Editing Comments .................................................................................................. 9-3
9.5 Deleting Comments................................................................................................ 9-4
9.5.1 Deleting All Comments ......................................................................................... 9-4
9.5.2 Deleting One Comment........................................................................................ 9-4
9.6 Exiting Comment Status ......................................................................................... 9-4
10 Body Mark............................................................................................10-1
10.1 Adding/changing Body Mark ................................................................................ 10-1
10.2 Moving Body Mark................................................................................................ 10-2
10.3 Clearing Body Mark.............................................................................................. 10-2
11 File System..........................................................................................11-1
11.1 Entering File System .............................................................................................11-1
11.2 Saving Files...........................................................................................................11-1
11.3 Opening Files ........................................................................................................11-2
11.4 File/Directory Management ...................................................................................11-4
11.4.1 Directory Management ......................................................................................11-4
11.4.2 File Management ...............................................................................................11-6
11.5 iVision ....................................................................................................................11-8
11.6 Sending DCM Files .............................................................................................11-10
11.7 Sending DCM Images .........................................................................................11-10
11.8 Exiting File System..............................................................................................11-11
12 Transducers and Biopsy ....................................................................12-1

iii
12.1 Transducers.......................................................................................................... 12-1
12.1.1 Name and Function of Each Part of the Transducer ........................................ 12-2
12.1.2 Orientation of the Ultrasound Image and the Transducer Head....................... 12-3
12.1.3 Procedures for Operating ................................................................................. 12-4
12.1.4 Wearing the Transducer Sheath ....................................................................... 12-7
12.1.5 Transducers Cleaning and Disinfection............................................................ 12-8
12.1.6 Storage and Transportation.............................................................................12-11
12.2 Biopsy Guide .......................................................................................................12-11
12.2.1 Needle-guided Brackets ................................................................................. 12-13
12.2.2 Names of Parts............................................................................................... 12-14
12.2.3 Inspection of the Needle-guided Bracket ....................................................... 12-19
12.2.4 Installing the Needle-guided Bracket.............................................................. 12-19
12.2.5 Entering Status of Guide Line Adjustment...................................................... 12-23
12.2.6 Selecting Guide Line ...................................................................................... 12-24
12.2.7 Adjusting Guide Line....................................................................................... 12-24
12.2.8 Displaying/hiding Guide Line.......................................................................... 12-24
12.2.9 Exiting Status of Guide Line Adjustment ........................................................ 12-25
12.2.10 Removing the Needle-guided Bracket.......................................................... 12-25
12.2.11 Clean and Sterilize the Needle-guided Bracket............................................ 12-27
12.2.12 Storage and Transportation.......................................................................... 12-28
12.2.13 Disposal........................................................................................................ 12-29
13 System Maintenance ..........................................................................13-1
13.1 Maintenance Performed by Users........................................................................ 13-1
13.1.1 Cleaning ........................................................................................................... 13-1
13.2 Maintenance Performed by Service Engineers.................................................... 13-2
13.3 Troubleshooting.................................................................................................... 13-3
14 Acoustic Power Principle ...................................................................14-1
14.1 Concerns with Bioeffects...................................................................................... 14-1
14.2 Prudent Use Statement ........................................................................................ 14-1
14.3 ALARA.................................................................................................................. 14-1
14.4 Derated Ultrasonic Output Parameters ................................................................ 14-2
14.5 Measurement Uncertainty .................................................................................... 14-2
14.6 Parameters Affecting Acoustic Power .................................................................. 14-3
14.7 Imaging Functions Changing Acoustic Output Power.......................................... 14-3
14.8 References for Acoustic Power and Safety.......................................................... 14-4

iv
Appendix A System Configuration ........................................................... A-1
Appendix B Specifications........................................................................ B-1
Appendix C Measurement Accuracy ........................................................ C-1
Appendix D Guidance and Manufacturer's Declaration ......................... D-1
Appendix E Maximum Surface Temperature of Transducers................. E-1
Appendix F Acoustic Output Reporting Table(61157-2007)................... F-1
Appendix G Safety Classification............................................................. G-1
Appendix H Input of Characters ............................................................... H-1
Appendix I Electrical Safety Inspection .....................................................I-1

I
© 2011-2012 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2012-09.
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.

II
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
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.

III
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]
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: [phone]
Fax: [phone]

IV
Important Information
1. The responsibility for maintenance and management of the product after delivery resides
with the customer who has purchased the product.
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 unacceptable
environmental conditions.
(4)Damage or loss due to use outside the territory in which the system was originally
sold.
(5)Damage or loss involving 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 product.
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 responsibility for diagnostic procedures lies with the physicians involved. Mindray
shall not be liable for the results of diagnostic procedures.
7. Important data must be backed up on external recording media such as clinical records,
notebooks etc.
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. Be alert at all
times to dangers other than those indicated. Mindray shall not be liable for damage or
loss that results from negligence or from ignoring the precautions and operating
instructions contained in this operator’s manual.
10. On the occasion of change of the administrator or manager for this system, be sure to
hand over this operator’s manual.

V
Preface
To ensure safe and correct operation of the system, carefully read and understand this
operator’s manual before operating the system.
Structure of Operator’s Manual
This manual mainly describes the structure, functions, installation, operation, maintenance of
the system.
This manual has two volumes.
Basic volume – describes the structure, functions, operations and maintenance of the system.
Advanced volume – describes the preset and measurements in detail.
Symbols in Operator’s Manual
The following table explains the safety symbols that may be used in this manual.
Symbol Signification
DANGER:
Indicates an imminently hazardous situation which, if not avoided, will
result in death or serious injury.
WARNING:
Indicates a potentially hazardous situation which, if not avoided, could
result in death or serious injury.
CAUTION:
Indicates a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury.
NOTE: Indicates a potentially hazardous situation which, if not avoided, may
result in property damage.

VI
Labels and Symbols on System
The following table explains the labels and symbols attached on the system.
Label or Symbol Signification
General warning, caution, risk of danger.
Before using the system, be sure to carefully read the relevant
content of this operator’s manual.
(a) General warning, caution, risk of danger.
(b) Urges Caution related to handling of the transducers. For
handling of the transducers, refer to the transducers’ manuals.
Cautions that the system must not be removed covers because the
high voltage may cause electric shock.
(a) (b)
This labels are available when the system works with the mobile
trolley.
(a) DO NOT sit on the system.
(b) DO NOT push the trolley when the casters are locked.
This label is available when the system works with the mobile trolley.
Open the keyboard before moving the trolley.
Type-BF applied part
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.
Dangerous voltage
Power button
Serial number
Date of manufacture
Manufacturer
AC (alternating current)

VII
Label or Symbol Signification
Ethernet port
Video output
Equipotential terminal
Remote control port
VGA VGA out
USB port
Transducer socket A
Transducer socket B
Reserved
Reserved
Brightness of the display
Contrast of the display
Authorized representative in the European Community.
The device is fully in conformance with the Council Directive
Concerning Medical Devices 93/42/EEC. The number adjacent to the
CE marking (0123) is the number of the EU-notified body.
The following definition of the WEEE label applies to EU member
states only: The use of this symbol indicates that this product should
not be treated as household waste. By ensuring that this product is
disposed of correctly, you will help prevent bringing potential negative
consequences to the environment and human health. For more
detailed information with regard to returning and recycling this
product, please consult the distributor from whom you purchased the
product.
* For system products, this label may be attached to the main unit
only.

VIII
Conventions
This manual uses the following way to mark keys on the control panel and words displayed on
the screen.
Keys on the control panel are marked with < >. For example, <Back> represents the “Back”
key on the control panel.
Words displayed on the screen are marked with [ ]. For example, [B MEAS] represents the
name of the “B MEAS” menu.
Figures
Depending on the model, software version, preset, options and so on, the figures in this
manual may appear different from what you see from your system.
The figures in this manual are only for reference or explanation.
Safety Precautions
Be sure to observe the following safety precautions.
DANGER: Do not use flammable gasses such as anesthetic gas,
oxygen or hydrogen, or flammable liquids such as
ethanol, near the system and probes, because there is
danger of explosion.
WARNING:
1. Only medical personnel fully trained in clinical
examination techniques can use the system.
2. Connect the power plug of the system to the wall
receptacle properly grounded and meeting the ratings
indicated on the rating nameplate.
3. When the system is connected with other equipments, be
sure to connect their equipotential terminals before
inserting any of their power plugs into a receptacle, and
also, be sure to remove the power plugs from receptacles
before disconnecting the equipotential terminals.
4. Use peripherals and optional parts provided with the
system or recommended. Use cables provided with the
system. Use other peripherals or cables may degrade
system performance or even cause electric shock.

IX
WARNING:
5. Do not connect the system to receptacles that control
current to devices such as life-support systems and are
equipped with the same circuit breakers and fuses as
those of the system. If the system malfunctions and
generates an 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. No waterproof device is applied to the system. Do not use
the system in any place with the possibility of water
ingress. There is risk of electric shock if any water is
sprayed on or into the system.
7. Use the system only in the environment specified in this
manual.
8. Use transducers specified in this manual. Using
transducers not specified in this manual may damage the
system and transducer or even cause an accident such as
a fire.
9. Use the transducer carefully. In case that the human body
contacts the scratched transducer surface, immediately
stop using the transducer and contact our company’s
Customer Service Department or your local distributor.
Using scratched transducer may cause electric shock.
10. If finding any abnormality in the system or transducer
during the scan, stop scanning immediately and turn off
the system.
11. The system and accessories are neither disinfected nor
sterilized before they are sold. Disinfect or sterilize
transducers and needle-guided brackets as the
transducers’ manuals describe before using them.
12. After disinfecting or sterilizing accessories, thoroughly
clear chemicals from the accessories. Residual chemicals
may damage the accessories and cause injury.
13. Do not let the patient contact the system or other
equipments. If the system or other equipments are
defective, electric shock may occur.
14. Do not subject transducers to knocks. Using defective
transducers may cause electric shock.
15. Do not open the shell or panel. Opening the shell or panel
when the system is connected to the receptacle may cause
short circuit or electric shock.
16. Do not use the system at the same time when using
equipment such as an electro-surgical unit,
high-frequency therapy equipment or a defibrillator, etc.

X
WARNING: 17. Before moving the system, power it off, close the control
panel and then remove all connections (including
connections to transducers). Then hold the system’s
handle to move the system to a proper location carefully.
18. Before cleaning the system, power it off and remove the
power plug from the receptacle to avoid electric shock.
19. To avoid system damage or electric shock, do not remove
the power plug from the receptacle before turning off the
system.
20. To avoid equipment damage or electric shock, do not
remove the power plug from the receptacle before turning
off the peripheral.
21. To avoid system or printer damage or electric shock, do
not connect/disconnect printer’s data cable before turning
off the system and printer.
22. Accessory equipments connected to the system’s
analogue and digital interfaces must be complied with the
relevant IEC standards (e.g., IEC 60950 Information
Technology Equipment standard and IEC 60601-1 Medical
Electrical Equipment standard). Furthermore all
configurations should comply with the standard
IEC60601-1-1. Everybody who connects additional
equipment to the signal input part or signal output part
configures a medical system, and is therefore responsible
that the system complies with the requirements of
IEC60601-1-1. If in doubt, consult our company’s Customer
Service Department or your local distributor.
23. Use ultrasound gel complying with local regulations.
24. This system is not intended for ophthalmic use.
CAUTION: 1. This manual does not describe clinical examination
techniques. Selection of proper clinical examination
technique must be based on specialized training and
clinical experience.
2. There is no risk of high-temperature burns during routine
ultrasound examinations. To prevent high-temperature
burns, do not apply the transducer to the same spot on the
patient for a long time. Apply the transducer only for as
long as required time for diagnosis.
3. Ensure the system date and time are consistent with
current date and time. If they are not consistent,
misdiagnosis may occur.

XI
4. Always keep the system dry. Do not move the system
quickly from a cold place to a warm one. Condensation or
water drops formed may cause short circuit.
5. If the circuit breaker is tripped or the fuse is blown, it
indicates that the system or peripherals have problems. In
these cases, do not repair by yourself but contact our
company’s Customer Service Department or your local
distributor.
6. Do not place any object on the system.
7. Ensure other equipments are secured before moving the
system. Otherwise, the equipments may fall and cause
injury.
8. Ensure proper measurement targets and images and
measurements are performed in valid image area. Incorrect
measurement results may cause misdiagnosis.
9. Prolonged or repeated use of the keys and trackball on the
control panel may result in hand or arm nerve disorders.
Observe the local safety/health regulations.
NOTE:
1. Do not use the system in the vicinity of strong electromagnetic
field (such as the transformer), which may affect the
performance of the monitor.
2. Using devices transmitting RF signals in the vicinity of the
system may affect the system’s performance. Do not use or take
any devices intentionally transmitting RF signals such as cellular
phones, transceivers and radio controlled products in the room
placing the system.
3. Transport, store and use the system under the circumstance
specified in this manual. Additionally, store and use the system
in a clean location where there is no direct sunlight, no sudden
changes in temperature, no condensation, few dust, no
vibration, and far from heat generators.
4. After turning off the system, wait at least 10 seconds before
turning it on again. Otherwise, failure may occur.
5. Before connecting/disconnecting the transducer, turn off the
system or stop emitting (freeze the image). Otherwise, the
system or transducer may malfunction.
6. After using the transducer, remove the gel on it and place it
properly. Otherwise, water in the gel may enter the acoustic lens
to adversely affect the performance and safety of the transducer.
7. If the system is used in a small room, the room temperature may
rise. Proper ventilation must be provided.
8. The system must keep good elimination of heat. Do not cover
radiation holes on the system.

XII
9. Only engineers of our company or authorized by our company
can replace the fuses.
10. Only perform operations described in this manual.
11. Do not modify system parameters. If it is necessary to change
system parameters, contact our company’s Customer Service
Department or your local distributor.
12. Deterioration of electrical and mechanical safety characteristics
(such as generation of a leakage current or
deformation/abrasion of mechanical parts) and of image
sensitivity and precision may occur over a period of time. Check
and maintain the system periodically. To ensure system
performance, it is recommended to sign a maintenance and
service contract to avoid accidents and misdiagnosis.
13. To dispose of the system or any part, contact our company’s
Customer Service Department or your local distributor first. Our
company does not assume any responsibility for damage
resulting from disposal of the system without consulting our
company.
14. When using this system with portable package, be careful not to
block the ventilation slots.
15. Do not use a USB memory device (e.g., a USB flash drive,
removable hard disk) which has unsafe data. Otherwise system
damage may result.
Please read the following precautions carefully to ensure the safety of the patient and the
operator when using the probes.
WARNING: 1.This ultrasonic probe is only for use with the specified
ultrasonic diagnostic system. Please refer to “A.3
Optional Transducers” to select the proper probe.
2.Confirm that the probe and cable are normal before and
after each examination. A defective probe may cause
electric shock to the patient.
3.Do not subject the probe to shock. A defective probe may
cause electric shock to the patient.
4.Do not disassemble the probe to avoid the possibility of
electric shock.
5.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.
6.Ultrasonic probe is only for use with the specified
ultrasonic diagnostic system. Please refer the ultrasonic
diagnostic system operation manual to select the proper
probe.
7.A probe sheath must be installed over the probe before
performing intra-cavity or intra-operative examination.

XIII
CAUTION: 1.When using the probe, wear sterile gloves to prevent infection.
2.Be sure to use ultrasound gel. Please use the ultrasound gel
compliant with the relevant local regulations.
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 probe. If the
carrying case is used for storage, it may become a source of
infection.
5.The probe and accessories supplied with it are not delivered
disinfected or sterilized. Sterilization (or high-level disinfect)
before use is required.
6.It is required to practice ALARA when operating ultrasound
system. Minimize the acoustic power without compromising the
quality of images.
7.Disposable components are packaged sterile and are
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 that
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 transducer material and damage
may result.
10. Transducer damage may be caused by inappropriate gel,
detergent or cleanser:
Do not soak or saturate transducers with solutions containing
alcohol, bleach, ammonium chloride compounds, acetone or
formaldehyde.
Avoid contact with solutions or coupling gels containing
mineral oil or lanolin.
NOTE: 1. Read the following precautions to prevent the probe from malfunction.
zBefore connecting or disconnecting the probe, freeze or turn off the
ultrasound diagnostic system.
zClean and disinfect the probe before and after each examination.
zAfter the examination, wipe off the ultrasound gel thoroughly.
Otherwise, the ultrasound gel may solidify and the image quality
would be degraded.
2. Ambient conditions:
To prevent the probe from being damaged, do not use it where it will be
exposed to:
zdirect sunlight or X-rays
zsudden changes in temperature

XIV
zdust
zexcessive vibration
zheat generators
Use the probes under the specified ambient conditions.
3. Repeated disinfection will eventually damage the probe, please check
the probe’s performance periodically.