Mindray TE7, TE5 Operator's Manual
TE7/TE5
Diagnostic Ultrasound System
Operator’s Manual
[Basic Volume]
Contents
Contents ............................................................................................................................... i
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 ....................................................................................................................... IV
Operator’s Manuals .......................................................................................................................... IV
Hardcopy Manuals ........................................................................................................................... IV
Software Interfaces in this Manual ................................................................................................... IV
Conventions ...................................................................................................................................... V
Product Differences ........................................................................................................................... V
1 Safety Precautions .................................................................................................... 1-1
1.1 Safety Classifications ........................................................................................................... 1-1
1.2 Meanings of Signal Words ................................................................................................... 1-2
1.3 Meaning of Safety Symbols ................................................................................................. 1-2
1.4 Safety Precautions ............................................................................................................... 1-3
1.5 Latex Alert .......................................................................................................................... 1-10
1.6 Warning Labels .................................................................................................................. 1-11
2 System Overview ...................................................................................................... 2-1
2.1 Intended Use ........................................................................................................................ 2-1
2.2 Product Specifications .......................................................................................................... 2-1
2.3 System Configuration ........................................................................................................... 2-2
2.4 Introduction of Each Unit ...................................................................................................... 2-8
2.5 Symbols .............................................................................................................................. 2-10
3 System Preparation .................................................................................................. 3-1
3.1 Move/Position the System .................................................................................................... 3-1
3.2 Power ON/OFF ..................................................................................................................... 3-2
3.3 Connecting the Power Cord ................................................................................................. 3-5
3.4 Connecting a Probe ............................................................................................................. 3-6
3.5 Connecting the Footswitch ................................................................................................... 3-7
3.6 Connecting USB Devices ..................................................................................................... 3-7
3.7 Installing a Graph/Text Printer .............................................................................................. 3-8
3.8 Installing a Video Printer .................................................................................................... 3-10
3.9 Brightness and Contrast Adjustment .................................................................................. 3-10
3.10 Display Position Adjustment ............................................................................................... 3-11
3.11 Basic Screen & Operation .................................................................................................. 3-12
4 Exam Preparation ..................................................................................................... 4-1
4.1 Patient Information ............................................................................................................... 4-1
4.2 Select Exam Mode and Probe ............................................................................................. 4-7
4.3 Select the Imaging Mode ..................................................................................................... 4-8
4.4 End an Exam ........................................................................................................................ 4-8
4.5 Activate an Exam ................................................................................................................. 4-8
5 Image Optimization ................................................................................................... 5-1
i
5.1 Imaging Mode ....................................................................................................................... 5-1
5.2 B Mode Image Optimization ................................................................................................. 5-4
5.3 M Mode Image Optimization .............................................................................................. 5-10
5.4 Color Mode Image Optimization ......................................................................................... 5-12
5.5 Power Mode Image Optimization ....................................................................................... 5-17
5.6 PW/CW Doppler Mode ....................................................................................................... 5-19
5.7 Contrast Imaging ................................................................................................................ 5-26
5.8 Anatomical M Mode ............................................................................................................ 5-33
5.9 TDI ...................................................................................................................................... 5-34
5.10 Color M Mode ..................................................................................................................... 5-36
5.11 3D Imaging ......................................................................................................................... 5-37
6 Display & Cine Review .............................................................................................. 6-1
6.1 Splitting Display .................................................................................................................... 6-1
6.2 Image Magnification ............................................................................................................. 6-1
6.3 iZoom (Full Screen View) ..................................................................................................... 6-1
6.4 Freeze/Unfreeze the Image. ................................................................................................. 6-2
6.5 Cine Review ......................................................................................................................... 6-2
6.6 Image Compare .................................................................................................................... 6-4
6.7 Cine Saving .......................................................................................................................... 6-6
6.8 Preset ................................................................................................................................... 6-6
7 Measurement ............................................................................................................. 7-1
7.1 Basic Operations .................................................................................................................. 7-1
7.2 General Measurements ........................................................................................................ 7-2
7.3 Advanced Measurements ..................................................................................................... 7-2
7.4 Measurement Accuracy ........................................................................................................ 7-3
8 Physiological Signal ................................................................................................. 8-1
8.1 ECG ...................................................................................................................................... 8-2
8.2 Parameters description......................................................................................................... 8-3
9 Annotations and Body Marks ................................................................................... 9-1
9.1 Annotations ........................................................................................................................... 9-1
9.2 Voice Comments .................................................................................................................. 9-4
9.3 Body Mark ............................................................................................................................ 9-5
9.4 Settings ................................................................................................................................. 9-6
10 Patient Data Management ....................................................................................... 10-1
10.1 Patient Information Management ....................................................................................... 10-1
10.2 Image File Management ..................................................................................................... 10-1
10.3 Report Management ........................................................................................................... 10-7
10.4 iStation - Patient Data Management .................................................................................. 10-9
10.5 Recycle bin ....................................................................................................................... 10-12
10.6 iStorage ............................................................................................................................ 10-12
10.7 Print .................................................................................................................................. 10-12
10.8 Back Up Files using the DVD Drive .................................................................................. 10-13
10.9 Patient Task Management ................................................................................................ 10-14
10.10 Administration ................................................................................................................... 10-15
10.11 V-Access ........................................................................................................................... 10-23
10.12 Q-Path .............................................................................................................................. 10-23
11 DICOM/HL7 .............................................................................................................. 11-1
11.1 DICOM Preset .................................................................................................................... 11-2
ii
11.2 Verify Connectivity ............................................................................................................ 11-10
11.3 DICOM Services ................................................................................................................ 11-11
11.4 DICOM Media Storage ..................................................................................................... 11-15
11.5 Structured Report ............................................................................................................. 11-17
11.6 DICOM Task Management ............................................................................................... 11-17
12 Setup........................................................................................................................ 12-1
12.1 System Preset .................................................................................................................... 12-2
12.2 Exam Related Preset ....................................................................................................... 12-22
12.3 Network Related Preset ................................................................................................... 12-24
13 Probes and Biopsy ................................................................................................. 13-1
13.1 Probes ................................................................................................................................ 13-1
13.2 Biopsy Guide .................................................................................................................... 13-16
13.3 Middle Line ....................................................................................................................... 13-44
13.4 eSpacial Navi ................................................................................................................... 13-45
14 DVR Recording ....................................................................................................... 14-1
14.1 Recording ........................................................................................................................... 14-1
14.2 Sending Image ................................................................................................................... 14-1
14.3 DVR Video Replaying......................................................................................................... 14-1
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 ...................................................................................................... 15-4
15.7 Acoustic Output .................................................................................................................. 15-4
15.8 Measurement Uncertainty .................................................................................................. 15-5
15.9 References for Acoustic Power and Safety ........................................................................ 15-6
16 Guidance and Manufacturer's Declaration ............................................................ 16-1
17 System Maintenance .............................................................................................. 17-1
17.1 Daily Maintenance .............................................................................................................. 17-1
17.2 Troubleshooting .................................................................................................................. 17-7
Appendix A Wireless LAN ........................................................................................A-1
Appendix B Battery ...................................................................................................B-1
Appendix C Barcode Reader ....................................................................................C-1
Appendix D Trolley and Accessories .......................................................................D-1
Appendix E Electrical Safety Inspection ................................................................. E-1
Appendix F iScanHelper ........................................................................................... F-1
Appendix G iWorks (Auto Workflow Protocol) ....................................................... G-1
Appendix H List of Vocal Commands ......................................................................H-1
iii
© 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All Rights Reserved.
For this Operator’s Manual, the issue date is 2019-07.
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.
I
NOTE:
Prescription use only.
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
Manufacturer:
Mindray DS USA, Inc.
Address:
800 MacArthur Blvd.
Mahwah, NJ 07430-0619 USA
Tel:
+1(201) 995-8000
Toll Free:
+1 (800) 288-2121
Fax:
+1 (800) 926-4275
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXTOUCHED 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
II
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:
(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.
About This Manual
This operator’s manual describes the operating procedures for TE7/TE5 Diagnostic Ultrasound
System and the compatible probes. To ensure safe and correct operation, carefully read and
understand the manual before operating the system.
III
NOTE:
Indicates information of interest to users of this system regarding exceptional
conditions or operating procedures.
CAUTION:
U.S.A. Federal Law restricts this device to sale by or on the order of a
physician.
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.
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.
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 screenshots, 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.
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.
IV
Product model
Feature
TE7
TE5
Double Dist
√
√
Depth
√
√
Parallel line
√
√
Spline length
√
x
NOTE:
Only TE7 is available in Canada.
Conventions
In this manual, the following conventions are used to describe the buttons on the display (main
screen), items in the menus, buttons in the dialog boxes and some basic operations:
[Items in menu or on the screen or buttons in dialog box]: square brackets indicate items in
menus or on the screen, or buttons in dialog boxes.
Tap [Items or Buttons]: tap the corresponding item on the screen.
[Items in menu] -> [Items in submenu]: select a submenu item following the path.
Product Differences
V
1 Safety Precautions
1.1 Safety Classifications
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:
The main unit is rated IPX0
The probes are rated IPX7
The foot switch (can be applied in the operating room) is rated IPX8.
The power adapter is rated IPX1.
According to the disinfection and sterilization method(s) recommended by manufacturer:
Equipment with disinfection and sterilization method(s) recommended by 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
According to the installation and use:
Portable equipment
Mobile equipment (when the system is installed on the trolley)
Does the equipment has any defibrillation-proof applied parts:
Non-defibrillation-proof applied part
Permanently installed equipment or non-permanently installed equipment:
Non-permanently installed equipment
Safety Precautions 1-1
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 use the system more effectively.
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.
General warning sign.
Caution!
Patient/user infection due to contaminated equipment. Be careful when
performing cleaning, disinfection and sterilization.
Patient injury or tissue damage from ultrasonic radiation. The ALARA
principle must be practiced when operating the ultrasound system.
1.2 Meanings 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.
1.3 Meaning of Safety Symbols
1-2 Safety Precautions
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 adapter power plug of this system and
power plugs of the peripherals to well-grounded 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 use the power supply method provided by
Mindray, other power supply modes (e.g. using a UPS) may
result in electric shock.
2.
Connect the protective grounding conductor before turning
ON the system. Disconnect the grounding cable after
turning OFF the system. Otherwise, electric shock may
result.
3.
For the connection of power and grounding, follow the
appropriate procedures described in this operator’s
manual. Otherwise, there is risk of electric shock. DO NOT
connect the grounding cable to a gas pipe or water pipe;
otherwise, improper protective grounding may result or a
gas explosion may occur.
4.
Before cleaning the system, disconnect the power cord
from the outlet. Failure to do so may result in system
failure and electric shock.
5.
This system is not water-proof designed. DO NOT use this
system in any place where water or any liquid leakage may
occur. If any water is sprayed on or into the system,
electric shock or device malfunction may result. If water is
accidentally sprayed on or into the system, power off the
system immediately and contact Mindray Customer Service
Department or sales representative.
6.
DO NOT use a probe that has a damaged, scratched
surface, or exposed wiring of any kind. Immediately stop
using the probe and contact Mindray Customer Service
Department or sales representative. There is risk of electric
shock if a damaged or scratched probe is used.
7.
DO NOT allow the patient to contact the live parts of the
ultrasound system or other devices, e.g. signal I/O ports.
Electric shock may occur.
1.4 Safety Precautions
Please observe the following precautions to ensure patient and operator’s safety when using this
system.
Safety Precautions 1-3
8.
Do not use an aftermarket probe other than those specified
by Mindray. The probes may damage the system, causing a
profound failure, e.g. a fire in the worst case.
9.
Do not subject the probes to knocks or drops. Use of a
defective probe may cause an electric shock.
10.
Do not open the covers and front panel of the system.
Short circuit or electric shock may result when the system
hardware is exposed and powered on.
11.
DO NOT use this system simultaneously with equipment
such as an electrosurgical unit, high-frequency therapy
equipment, or a defibrillator, etc. This would result in a risk
of electric shock to the patient.
12.
When moving the system, you should first fold the LCD
display, disconnect the system from other devices
(including probes) and disconnect the system from the
power supply.
13.
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 chapter 16 ME System. 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 chapter 16
ME System. If you have any questions regarding these
requirements, consult your sales representative.
14.
Prolonged and repeated use of display controls may result
in hand or arm nerve disorders for some individuals.
Observe the local safety or health regulations concerning
the use.
15.
DO NOT contact both the patient and the ultrasound
system or the live parts of the ultrasound system (e.g.
signal I/O ports). Electric shock may occur.
16.
When using intra-cavity transducers, do not activate the
transducer outside the patient’s body.
17.
If you have any doubts of the installation or routing of
external protective cables, use the internal power supply
of the system.
18.
DO NOT put the ultrasound system in any soft materials
(e.g. soft cloth or cotton, etc.) in case that the air vent
becomes blocked.
19.
Always read and follow carefully the manufacturer
instructions on the contrast agent label.
20.
Only use the ECG leads provided with the ECG module;
otherwise electric shock may result.
1-4 Safety Precautions
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 waves:
If a device emitting radio waves 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) into the
room where the system is located.
If a person brings a device that generates radio
waves near the system, ask him / her to immediately
turn OFF the device.
3.
Precautions concerning movement of the system:
When you place the system on the trolley and move
them together, you must secure all objects on the
trolley to prevent them from falling. Otherwise you
should separate the system from the trolley and
move them individually.
When you have to move the system with the trolley
upward or downward the stairs, you must separate
them first and then move them individually.
Object placed on the display may fall and injure an
individual when moving.
Confirm that there is no peripheral device connected
to the system before moving the system. Otherwise,
peripheral device may fall and cause injury.
4.
DO NOT expose the system to excessive vibration through
transportation. Mechanical damage may result.
5.
Do not connect this system to outlets with the same circuit
breakers and fuses that control the current of devices such
as life-support systems. If this system malfunctions and
generates over current, or when there is an instantaneous
current at power ON, the circuit breakers and fuses of the
building’s supply circuit may be tripped.
6.
Always keep the system dry. Avoid transporting this system
quickly from a cold place to a warm place; otherwise
condensation or water droplets may form allowing a short
circuit and possible electric shock.
7.
If the circuit protector is tripped, it indicates that the system
or a peripheral device was improperly shut down and that the
system is unstable. You cannot repair the system under this
circumstance and must call the Mindray Customer Service
Department or sales representative.
Safety Precautions 1-5
8.
There is no risk of high-temperature burns during normal
ultrasound examinations. It is possible for the surface
temperature of the probe to exceed the body temperature of a
patient due to environmental temperature and exam mode
combinations. Apply the probe only for a period of time
required for the purpose of diagnosis.
9.
The system and its accessories are not disinfected or
sterilized prior to delivery. The operator is responsible for the
cleaning and disinfection of probes and sterilization of
biopsy brackets according to the manuals, prior to the use.
All items must be thoroughly processed to completely
remove harmful residual chemicals, which will not only be
harmful to the human body, but also damage the accessory.
10.
It is necessary to tap [End] in the bottom-left corner of the
operating panel to end the current scan that is in progress
and clear the current Patient Information field. Failure to do
so may result in new patient data being combined with data
of the previous patient.
11.
DO NOT connect or disconnect the system’s power cord or
its accessories (e.g., a printer or a recorder) without turning
OFF the power first. This may damage the system and its
accessories or cause electric shock.
12.
If the system is powered off improperly during operation, it
may result in data damage of the system’s hard disk or
system failure.
13.
Do not use the system to examine a fetus for a long period of
time.
14.
Do not use a USB memory device (e.g., a USB flash drive,
removable hard disk) which has unsafe data. Otherwise,
system damage may result.
15.
It is recommended to only use the video devices specified in
this manual.
16.
Do not use gel, disinfectant, probes, probe sheath or needleguided brackets that are not compatible with the system.
17.
Read the Acoustic Output Principle in the operation manual
carefully before operate this system on clinical examination.
18.
Please use the ultrasound gel compliant with the relevant
local regulations.
NOTE:
1.
DO NOT use the system in the vicinity of strong electromagnetic field (such as a
transformer), which may affect the performance of the system.
2.
DO NOT use the system in the vicinity of high-frequency radiation source, which
may affect the performance of the system or even lead to failure.
1-6 Safety Precautions
3.
To avoid damaging the system, DO NOT use it in following environment:
(1) Locations exposed to direct sunlight.
(2) Locations subject to sudden changes in environmental temperature.
(3) Dusty locations.
(4) Locations subject to vibration.
(5) Locations near heat generators.
(6) Locations with high humidity.
4.
Turn ON the system only after the power has been turned OFF for a while. If the
system is turned ON immediately after being turned OFF, the system may not be
rebooted properly and could malfunction.
5.
When using or placing the system, keep the system horizontal to avoid
imbalance.
6.
Remove ultrasound gel from the face of a probe when the examination is
complete. Water in the gel may enter the acoustic lens and adversely affect the
performance and safety of the probe.
7.
You should properly back up the system to a secure external storage media,
including system configuration, settings and patient data. Data stored to the
system’s hard drive may be lost due to system failure, improper operation or
accident.
8.
Do not apply external force to the touch screen; otherwise, the system may be
damaged.
9.
If the system is used in a small room, the room temperature may rise. Please
provide proper ventilation and free air exchange.
10.
To dispose of the system or any part, contact Mindray Customer Service
Department or sales representative. Mindray is not responsible for any system
content or accessories that have been discarded improperly.
11.
Electrical and mechanical performance may be degraded due to long period of
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.
12.
Ensure that the current exam date and time are the same as the system date
and time.
13.
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.
14.
Use detachable power supply cord as mains power breaking device. DO NOT
set equipment in a place where it is difficult to disconnect the detachable power
supply cord！
Safety Precautions 1-7
WARNING:
1.
The ultrasonic probe is only for use with the specified ultrasonic
diagnostic system. Please refer to the 2.3.2 Probes and Needle-
guided Brackets Available 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 as this may cause electric shock
or malfunction.
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.
A probe sheath must be installed over the probe before
performing intra-cavity or intra-operative 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 probe. 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 the accessories supplied with it are not delivered
disinfected or sterilized. Sterilization (or high-level disinfection)
is required before use.
7.
Disposable components (for example the probe sheath, the
sterile gloves) are packaged sterile and are single-use only. Do
not use if the integrity of the packaging has been violated or if
the expiration date has passed. Use disposable components
which comply 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.
Please read the following precautions carefully to ensure the safety of the patient and the operator
when using the probes.
1-8 Safety Precautions
9.
The probe sheath contains natural rubber that can cause allergic
reactions in some individuals.
10.
Do not use pre-lubricated condoms as a sheath. Lubricant may
not be compatible with the transducer material and damage may
result.
11.
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.
12.
The contrast agent used must comply with the relevant local
regulations.
NOTE:
1.
Read the following precautions to prevent the probe from malfunction:
Clean and disinfect the probe before and after each examination.
After the examination, wipe off the ultrasound gel thoroughly. Otherwise,
the ultrasound gel may solidify and the image quality would be degraded.
Safety Precautions 1-9
2.
Ambient conditions:
To prevent the probe from being damaged, do not use it where it will be exposed
to:
Direct sunlight or X-rays
Sudden changes in temperature
Dust
Excessive vibration
Heat generators
Use the probes under the following ambient conditions:
ambient temperature: 0°C ～ 40°C
relative humidity: 30% ~ 85% (no condensation)
atmospheric pressure: 700 hPa ~ 1060 hPa.
Use the probe L14-5sp under the following ambient conditions:
ambient temperature: 10°C ~ 40°C
relative humidity: 30% ~ 85% (no condensation)
atmospheric pressure: 700 hPa ~ 1060 hPa.
Use the probe SC6-1s, SP5-1s, L11-3VNs, L12-3RCs, L14-5Ws and L9-3s under the
following working conditions:
ambient temperature: 0°C ~ 40°C
relative humidity: 20% ~ 85% (no condensation)
atmospheric pressure: 700 hPa ~ 1060 hPa.
Use the probe L20-5s under the following working conditions:
ambient temperature: 0°C ~ 35°C
relative humidity: 15% ~ 80% (no condensation)
atmospheric pressure: 700 hPa ~ 1060 hPa.
Use the probe C4-1s under the following working conditions:
ambient temperature: 0°C ~ 35°C
relative humidity: 15% ~ 90% (no condensation)
atmospheric pressure: 700 hPa ~ 1060 hPa.
3.
Repeated disinfection will eventually damage the probe, please check the probe's
performance periodically.
WARNING:
Allergic reactions in patients sensitive to latex (natural rubber) may
range from mild skin reactions (irritation) to fatal anaphylactic
shock, and may include difficulty breathing (wheezing), dizziness,
shock, swelling of the face, hives, sneezing, or itching of the eyes
(FDA Medical Alert on latex products, “Allergic Reactions to Latexcontaining Medical Devices”, issued on March 29, 1991).
1.5 Latex Alert
When choosing a probe sheath, it is recommended that you directly contact CIVCO for obtaining
information regarding probe sheaths, pricing, samples and local distribution. For CIVCO
information, please contact the following:
CIVCO Medical Instruments, Tel: 1-800-445-6741; www.civco.com
1-10 Safety Precautions
No.
Warning Labels
Meaning
1.
CONFORMS TO AAMI Std. ES 60601-1, IEC Std.
60601-2-37，IEC Std. 60601-2-18;
CERTIFIED TO CSA Std. C22.2 NO. 60601-1,
60601-2-37, 60601-2-18
2.
Read this information carefully before using the
system.
3.
The following labels are available
when the system works with the
mobile trolley.
(a) Do not place the system with the mobile trolley
on a sloped surface. Otherwise the system may
slide, resulting in personal injury or the system
malfunction. Two persons are required to move the
system over a sloped surface.
b DO NOT sit on the trolley.
c When the casters are locked, DO NOT push the
trolley.
4.
Non-ionizing radiation
a
b
c
1.6 Warning Labels
Warning labels are attached to this system to call your attention to potential hazards. The symbol
on warning labels indicates safety precautions.
The warning labels use the same signal words as those used in the operator’s manual. Read the
operator’s manual carefully before using the system.
The name, design and meaning of each warning label are described as follows:
Safety Precautions 1-11
NOTE:
The functions described in the operator’s manual may vary depending on the specific
system purchased.
Only TE7 is available in Canada.
B Mode
B
M Mode
M
Free Xros M
C Mode
Color
Power (DirPower)
D Mode
PW/CW
Special imaging
Smart 3D
TDI
Color M
Left Ventricular Opacification (LVO)
Contrast
Voltage
100-240V~;
19Vdc（DCU direct input）
Frequency
50/60Hz
Power input
2.0A (Power adapter)
3.5A (Trolley)
Fuse
T5AL, 250Vac (Power adapter)
Battery
14.8Vdc
2 System Overview
2.1 Intended Use
TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric
patients and neonates. It is intended for use in fetal, abdominal, intra-operative (abdominal,
thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic,
trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial),
urology, peripheral vessel, adult and pediatric cardiac, ophthalmic exams.
2.2 Product Specifications
2.2.1 Imaging Mode
2.2.2 Power supply
System Overview 2-1
Operating conditions
Storage and transportation conditions
Ambient temperature
0°C~40°C
-20°C~55°C
Relative humidity
30%~85% (no condensation)
20%~95% (no condensation)
Atmospheric pressure
700hPa~1060hPa
700hPa~1060hPa
WARNING:
Do not use this system in conditions other than those specified.
2.2.3 Environmental Conditions
2.2.4 Dimensions and Weight
Dimensions (including probe holder): 130±10 (Depth) x 380±10 (Width) x 380±5 (Height) mm
Weight (including batteries, three-probe socket configuration and one probe): <8.2Kg.
2.3 System Configuration
2.3.1 Standard Configuration
Main unit (select configuration between one-probe socket and three-probe socket)
Batteries (built-in)
SSD card (built-in)
System software
Wireless adapter (built-in)
iScanHelper
Accessories
Operator’s manuals and operation note
Ultrasound gel (made by Eco-Med Pharmaceuticals, model: Eco Gel 200, K955246)
Probe holder
Applied part: probes.
2-2 System Overview
Probe
model
Probe Type
Intended Use
Region Applied
C5-2s
Convex
Fetal, abdominal, pediatric, peripheral vessel
Body surface
C11-3s
Convex
Abdominal, pediatric, neonatal cephalic,
Cardiac Pediatric, peripheral vessel
Body surface
L12-4s
Linear
Ophthalmic, Abdominal, Pediatric, Small
organ, musculo-skeletal (conventional,
superficial), Peripheral vessel
Body surface
L7-3s
Linear
Abdominal, pediatric, small organ (breast,
thyroid, testes), musculo-skeletal
(conventional, superficial), peripheral vessel
Body surface
L14-6s
Linear
Pediatric, small organ (breast, thyroid, testes),
neonatal cephalic, musculo-skeletal
(conventional, superficial), peripheral vessel
Body surface
L14-6Ns
Linear
Ophthalmic, Pediatric, small organ (breast,
thyroid, testes), musculo-skeletal
(conventional, superficial), Peripheral vessel
Body surface
P4-2s
Phased
Fetal, Abdominal, pediatric, neonatal cephalic,
adult cephalic, cardiac adult, cardiac pediatric
Body surface
V11-3Ws
Convex
Fetal, trans-rectal, trans-vaginal, urology
Transvaginal
Trans-rectal
7LT4s
Linear
Abdominal, intra-operative (abdominal,
thoracic and vascular etc.), pediatric, small
organ (breast, thyroid, testes), neonatal
cephalic, musculo-skeletal (conventional,
superficial), peripheral vessel
Body surface/
intra-operative
P7-3Ts
Phased
Trans-esoph.(cardiac)
Transesophageal
L14-5sp
Linear
Abdominal, Intra-operative(abdominal, thoracic
and vascular etc.), Pediatric, small organ
(breast, thyroid, testes), Neonatal Cephalic,
musculo-skeletal (conventional, superficial),
peripheral vessel
Body surface/
intra-operative
P10-4s
Phased
Abdominal, pediatric, neonatal cephalic,
cardiac pediatric
Body surface
L20-5s
Linear
Ophthalmic, Small organ (breast, thyroid,
testes), musculo-skeletal (conventional,
superficial), peripheral vessel
Body surface
SC6-1s
Convex
Fetal, Abdominal, Pediatric, Musculo-skeletal
(Conventional), Peripheral vessel
Body surface
6CV1s
Convex
Fetal, Trans-rectal, Trans-vaginal, Urology
Trans-vaginal
Trans-rectal
7L4s
Linear
Abdominal, pediatric, small organ (breast,
thyroid, testes), neonatal cephalic, musculoskeletal (conventional, superficial), peripheral
vessel
Body surface
2.3.2 Probes and Needle-guided Brackets Available
System Overview 2-3
Probe
model
Probe Type
Intended Use
Region Applied
P7-3s
Phased
Abdominal, pediatric, neonatal cephalic, adult
cephalic, cardiac adult, cardiac pediatric
Body surface
SP5-1s
Phased
Fetal, Abdominal, Pediatric, Neonatal
Cephalic, Adult Cephalic, Cardiac Adult,
Cardiac Pediatric
Body surface
L9-3s
Linear
Abdominal, Pediatric, small organ (breast,
thyroid, testes), musculo-skeletal
(conventional, superficial), Peripheral vessel
Body surface
L11-
3VNs
Linear
Abdominal, Pediatric, small organ (breast,
thyroid, testes), musculo-skeletal
(conventional, superficial), Peripheral vessel
Body surface
C5-1s
Convex
Fetal, Abdominal, Pediatric, Peripheral vessel
Body surface
C4-1s
Convex
Fetal, Abdominal, Pediatric, Musculo-skeletal
(Conventional), Cardiac Adult
Body surface
L14-5Ws
Linear
Abdomen, Pediatric, small organ (breast,
thyroid, testes), musculo-skeletal
(conventional, superficial), Peripheral vessel
Body surface
L12-
3RCs
Linear
Abdominal, Pediatric, small organ (breast,
thyroid, testes), musculo-skeletal
(conventional, superficial), Peripheral vessel
Body surface
Probe model
Needle-guided
Bracket Model
Biopsy
angle/depth
(±1°)
Applicable Biopsy Needle
V113Ws/6CV1s
NGB-004
metal/needle
non-detachable
/
16G, 17G, 18G
L12-4s/ L7-3s/
L14-6Ns/ 7L4s
NGB-007
plastic/needle
detachable
metal/needle
detachable
40°, 50°, 60°
Metal: 14G, 16G, 18G, 20G, 22G
Plastic: 13G, 15G, 16G, 18G, 20G
7LT4s
NGB-010
(metal/needle
detachable)
30°, 40°, 50°
13G, 15G, 16G, 18G, 20G
P4-2s/SP5-1s
NGB-011
metal/needle
non-detachable
11°, 23°
13G, 15G, 16G, 18G, 20G
C5-2s
NGB-015
Metal/needle
detachable
25°, 35°, 45°
14G, 16G, 18G, 20G, 22G
Some of the probes have corresponding needle-guided brackets for biopsy. The available probes
and the corresponding needle-guided brackets are listed as follows:
2-4 System Overview
Probe model
Needle-guided
Bracket Model
Biopsy
angle/depth
(±1°)
Applicable Biopsy Needle
L14-6s
NGB-016
Metal/needle
detachable
30°, 40°, 50°
14G, 16G, 18G, 20G, 22G
C11-3s
NGB-018
metal/needle
detachable
15°, 25°, 35°
14G, 16G, 18G, 20G, 22G
SC6-1s/ C5-1s
NGB-022
Metal-needle
detachable
25°, 35°, 45°
Metal: 14G, 16G, 18G, 20G, 22G
L9-3s
NGB-034
Metal-needle
detachable
40°, 50°, 60°
4G, 16G, 18G, 20G, 22G
L14-5Ws
NGB-035
Metal-needle
detachable
47°, 53°, 59°, 65°
14G、16G、18G、20G、22G
C4-1s
NGB-036
Metal-needle
detachable
7°, 25°, 35°
14G、16G、18G、20G、22G
Probe model
Needle-guided Bracket Model
L14-6Ns、L12-4s
CIVCO 658-001
C5-2s
CIVCO 658-002
L14-5sp
CIVCO 698-006
C4-1s
CIVCO 698-019
V11-3Ws
CIVCO 610-543
V11-3Ws
CIVCO 610-1274
L14-5Ws
CIVCO 698-007
L14-5Ws
CIVCO 698-012
NOTE:
Some features may not be available in some countries due to pending regulatory
approvals.
Disposable needle-guided bracket
Some of the probes have corresponding disposable needle-guided brackets for biopsy. The
available probes and the corresponding disposable needle-guided brackets are listed as follows
Note: The disposable needle-guided brackets are not configured or sold by Mindray. The user can
purchase them based on the specific needs. See CIVCO for the use of each disposable needleguided bracket.
System Overview 2-5
2.3.3 Options
No.
Item
Remarks
1.
Footswitch
Types: 2-pedal/3-pedal
2.
Trolley See chapter “Appendix D Trolley and Accessories” for details.
3.
Wall mount/Table stand
After the wall mount/table stand is configured,
power adapter and cables should be
configured.
4.
Power adapter
Table stand or wall mounting bracket should
be configured.
5.
Power cable
The power adapter should be configured.
6.
ECG module
The ECG module should be configured.
7.
ECG cables
ECG module should be configured.
8.
DC-IN cable
ECG module should be configured.
9.
Travelling case
After the travelling case is configured, power
adapter and cables must be selected.
10.
External DVD recorder
/
11.
Barcode reader
/
12.
Trolley box
/
13.
iVocal microphone
/
14.
CW
/
15.
LVO
/
16.
iNeedle
/
17.
Abdomen/General Package
/
18.
Obstetrical Package
/
19.
Gynecology Package
/
20.
Cardiac Package
/
21.
Small Parts Package
/
22.
Urological Package
/
23.
Vascular Package
/
24.
Nerve Package
/
25.
Emergency & Critical Package
/
26.
Pediatrics Package
/
27.
DICOM
DICOM Basic (including verify
(SCU and SCP), task
management, DICOM Storage,
DICOM Print, DICOM Storage
Commitment, DICOM Media
Storage (including DICOM
DIR))
/
DICOM Worklist
DICOM Basic should be configured.
2-6 System Overview
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