Mindray M5 User manual

M5 Diagnostic Ultrasound System
Operator’s Manual
[Basic Volume]

i
Table of Contents
Table of Contents ............................................................................................i
Intellectual Property Statement .....................................................................I
Warranty ................................................................................................II
Return Policy ...............................................................................................III
Company Contact ........................................................................................ IV
Important Information................................................................................... V
Introduction .............................................................................................. VI
Safety Precautions..................................................................................... VIII
1Overview .............................................................................................1-1
1.1 Intended Use .................................................................................................. 1-1
1.2 Product and Model Code ................................................................................ 1-1
2Product Specifications .........................................................................2-1
2.1 Imaging Modes ............................................................................................... 2-1
2.2 Power Supply (Adapter).................................................................................. 2-1
2.3 Environmental Conditions ............................................................................... 2-1
2.4 External Dimensions and Weight.................................................................... 2-1
3System Configuration...........................................................................3-1
3.1 Standard Configuration ................................................................................... 3-1
3.2 Transducers Available..................................................................................... 3-1
3.3 Options ........................................................................................................... 3-2
3.4 Peripherals Supported .................................................................................... 3-3
4System Introduction .............................................................................4-1
4.1 Introduction of Each Unit................................................................................. 4-1
4.2 Extend Modules .............................................................................................. 4-3
4.3 Control Panel .................................................................................................. 4-6
4.4 Symbols ........................................................................................................ 4-11
5Set-up & Connections...........................................................................5-1
5.1 System Set-up ................................................................................................ 5-1
5.2 Power Supply.................................................................................................. 5-1
5.3 Connecting / Disconnecting a Transducer ...................................................... 5-2
5.4 Connecting the Probe Extend Module ............................................................ 5-3
5.5 Connecting IO Extend Module ........................................................................ 5-4
5.6 Connecting the V/A Extend Module ................................................................ 5-4

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5.7 Connecting the ECG Module .......................................................................... 5-4
5.8 Connecting the Footswitch.............................................................................. 5-5
5.9 Connecting / Removing a USB Memory Device ............................................. 5-5
5.10 Installing a Graph / Text Printer....................................................................... 5-6
5.11 Installing a Video Printer ................................................................................. 5-7
5.12 Use of the Drawbar Case................................................................................ 5-9
5.13 Use of M-Pack .............................................................................................. 5-11
6Power ON / OFF.....................................................................................6-1
6.1 Powering ON the System................................................................................ 6-1
6.2 Powering OFF the System.............................................................................. 6-3
7Basic Screen and Operation ................................................................7-1
7.1 Basic Screen................................................................................................... 7-1
7.2 Basic Operations of Screens .......................................................................... 7-5
8Patient Information ...............................................................................8-1
8.1 Entering / Exiting Patient Information Screen ................................................. 8-1
8.2 Setting Patient Information Display................................................................. 8-2
8.3 Entering Patient Information ........................................................................... 8-3
8.4 Searching a Patient ........................................................................................ 8-7
8.5 Worklist ........................................................................................................... 8-8
9Exam Types ...........................................................................................9-1
9.1 Introduction of Exam Types ............................................................................ 9-1
9.2 Selecting Transducer and Exam Type ............................................................ 9-2
9.3 Setting Exam Types ........................................................................................ 9-3
10 Image Modes .......................................................................................10-1
10.1 Image Modes ................................................................................................ 10-1
10.2 Switching Between Image Modes................................................................. 10-2
10.3 Image Adjustments ....................................................................................... 10-3
10.4 Image Parameter Preset............................................................................. 10-21
11 Special Imaging Modes ......................................................................11-1
11.1 Smart3D........................................................................................................ 11-1
11.2 iScape......................................................................................................... 11-14
12 Cine Review.........................................................................................12-1
12.1 Entering / Exiting Cine Review...................................................................... 12-1
12.2 Cine Review in the B or C Mode................................................................... 12-2
12.3 Cine Review in the M or D Mode .................................................................. 12-2

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12.4 Linked Cine Review ...................................................................................... 12-3
12.5 Setting Region of Auto Review ..................................................................... 12-3
12.6 Saving Cine .................................................................................................. 12-4
12.7 Cine Setup .................................................................................................... 12-4
13 Measurements.....................................................................................13-1
13.1 Basic Operations .......................................................................................... 13-1
13.2 General Measurements ................................................................................ 13-2
13.3 Application Measurements............................................................................ 13-3
14 Comments (Annotations) ...................................................................14-1
14.1 Entering / Exiting Comments ........................................................................ 14-1
14.2 Comment Menu ............................................................................................ 14-2
14.3 Adding Comments ........................................................................................ 14-3
14.4 Moving Comments........................................................................................ 14-4
14.5 Modifying (Editing) Comments...................................................................... 14-5
14.6 Deleting Comments ...................................................................................... 14-6
14.7 Comment Preset........................................................................................... 14-6
15 Body Marks (Pictograms)...................................................................15-1
15.1 Entering / Exiting Body Mark Mode............................................................... 15-1
15.2 Categories of Body Marks............................................................................. 15-1
15.3 Soft Menu for Body Marks ............................................................................ 15-1
15.4 Adding Body Marks....................................................................................... 15-2
15.5 Moving Body Marks ...................................................................................... 15-2
15.6 Deleting Body Marks..................................................................................... 15-3
15.7 Body Mark Preset ......................................................................................... 15-3
16 Patient File Management ....................................................................16-1
16.1 Image File Formats....................................................................................... 16-1
16.2 Memory Media .............................................................................................. 16-2
16.3 Storing Image Files ....................................................................................... 16-2
16.4 Storage and Management of an Exam Report.............................................. 16-5
16.5 iStation - Patient Data Management ............................................................. 16-6
16.6 Image Review and Analysis .......................................................................... 16-8
16.7 iVision ......................................................................................................... 16-11
16.8 Sending Image File..................................................................................... 16-12
16.9 Print Job Management................................................................................ 16-13
16.10 Backing Up Files through DVD-RW ............................................................ 16-14

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16.11 Reviewing the AVI Files .............................................................................. 16-16
17 Parameter Setup .................................................................................17-1
17.1 Entering / Exiting Setup ................................................................................ 17-1
17.2 System Setup ............................................................................................... 17-2
17.3 Exam Mode Preset ....................................................................................... 17-4
17.4 Image Parameter Preset............................................................................... 17-4
17.5 Comment Preset........................................................................................... 17-5
17.6 Body Mark Preset ......................................................................................... 17-5
17.7 Measurement Preset .................................................................................... 17-5
17.8 Key and Menu Preset ................................................................................... 17-5
17.9 Peripheral Setup ........................................................................................... 17-8
17.10 Manage Settings......................................................................................... 17-11
17.11 Maintenance ............................................................................................... 17-11
17.12 System Information..................................................................................... 17-11
18 Biopsy Guide.......................................................................................18-1
18.1 Entering or Exiting Biopsy Menu................................................................... 18-1
18.2 Displaying Biopsy Guide Lines ..................................................................... 18-1
18.3 Verifying the Biopsy Guide Line .................................................................... 18-2
19 ECG ...........................................................................................19-1
19.1 ECG Connection........................................................................................... 19-2
19.2 Displaying ECG Signal ................................................................................. 19-2
19.3 ECG Triggering ............................................................................................. 19-3
19.4 ECG Review ................................................................................................. 19-3
19.5 Exiting ECG .................................................................................................. 19-3
19.6 Setting ECG.................................................................................................. 19-4
20 Image Recording.................................................................................20-1
20.1 VCR (Video Cassette Recorder)................................................................... 20-1
20.2 DVR (Digital Video Recorder) ....................................................................... 20-4
21 Batteries ...........................................................................................21-1
21.1 Overview....................................................................................................... 21-1
21.2 Precautions................................................................................................... 21-1
21.3 Installing and Removing the Batteries........................................................... 21-2
21.4 Battery Status Indicator................................................................................. 21-3
21.5 One Full Discharge / Charge Cycle .............................................................. 21-3
21.6 Checking Battery Performance ..................................................................... 21-4

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21.7 Battery Disposal............................................................................................ 21-4
22 System Maintenance ..........................................................................22-1
22.1 Daily Maintenance ........................................................................................ 22-1
22.2 Maintenance Checks by Service Engineer ................................................... 22-3
22.3 Consumables and Periodic Part Replacement ............................................. 22-4
22.4 Troubleshooting ............................................................................................ 22-4
23 Acoustic Output ..................................................................................23-1
23.1 Concerns with Bioeffects .............................................................................. 23-1
23.2 Prudent Use Statement................................................................................. 23-1
23.3 ALARA Principle (As Low As Reasonably Achievable) ................................. 23-2
23.4 MI/TI Explanation.......................................................................................... 23-2
23.5 Acoustic Power Setting ................................................................................. 23-4
23.6 Acoustic Power Control................................................................................. 23-5
23.7 Acoustic Output ............................................................................................ 23-6
23.8 Measurement Uncertainty............................................................................. 23-7
23.9 References for Acoustic Power and Safety................................................... 23-8
24 Measurement Accuracy......................................................................24-1
25 Safety Classification...........................................................................25-1
26 Guidance and Manufacturer's Declaration .......................................26-1
Appendix A DICOM................................................................................ A-1

I
© 2007-2009 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2009-07.
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.
,, , , 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:
•all installation operations, expansions, changes, modifications and repairs of this product

II
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.
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Definitions
zMain unit: Integrated facilities which implements the specified function separately.
Generally speaking, the main unit should include power supply, control system and
some functional modules.
zAccessories: Materials connected to the main unit to extend or implement specified
function.
zConsumables: Disposable or short-life parts which should be replaced each time after
use or periodically.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the
improper use or application of the product or the use of parts or accessories not approved by
Mindray or repairs by people other than Mindray authorized personnel.

III
This warranty shall not extend to:
¾Malfunction or damage caused by improper use or man-made failure.
¾Malfunction or damage caused by unstable or out-of-range power input.
¾Malfunction or damage caused by force majeure such as fire and earthquake.
¾Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
¾Malfunction of the instrument or part whose serial number is not legible enough.
¾Others not caused by instrument or part itself.
The standard warranty period is as below:
¾Main unit: 18 months from shipment
¾Accessories: 15 months from shipment
¾Main Accessories include transducers, cables
¾Batteries: 6 months from shipment
¾Consumables: N/A
Return Policy
Return Procedure
In the event that it becomes necessary to return this product or part of this product to Mindray,
the following procedure should be followed:
1. Return authorization: Contact the international Customer Service Department and obtain
a Return Materials Authorization number. This number must appear on the outside of the
shipping container. Returned shipments will not be accepted if the number is not clearly
visible. Please provide the model number, serial number, and a brief description of the
reason for return.
2. Freight policy: The customer is responsible for freight charges when this product is
shipped to Mindray for service (this includes customs charges).
3. Return address: Please send the part(s) or equipment to the address offered by the
international Customer Service Department

IV
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
E-mail Address: [e-mail]
Tel: [phone] 26582888
Fax: [phone] 26582500
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: [phone]
Fax: [phone]

V
Important Information
1. It is the customer’s responsibility to maintain and manage the system after delivery.
2. The warranty does not cover the following items, even during the warranty period:
a. Damage or loss due to misuse or abuse.
b. Damage or loss caused by Acts of God such as fires, earthquakes, floods,
lightning, etc.
c. Damage or loss caused by failure to meet the specified conditions for this system,
such as inadequate power supply, improper installation or environmental
conditions.
d. Damage or loss due to use of the system outside the region where the system was
originally sold.
e. Damage or loss involving the system purchased from a source other than Mindray
or its authorized agents.
3. This system shall not be used by persons other than fully qualified and certified medical
personnel.
4. Do not make changes or modifications to the software or hardware of this system.
5. In no event shall Mindray be liable for problems, damage, or loss caused by relocation,
modification, or repair performed by personnel other than those designated by Mindray.
6. The purpose of this system is to provide physicians with data for clinical diagnosis.
7. It is the physician’s responsibility for diagnostic procedures. Mindray shall not be liable for
the results of diagnostic procedures.
8. Important data must be backed up on external memory media.
9. Mindray shall not be liable for loss of data stored in the memory of this system caused by
operator error or accidents.
10. This manual contains warnings regarding foreseeable potential dangers, but you shall
always be alert to dangers other than those indicated as well. Mindray shall not be liable
for damage or loss that results from negligence or from ignoring the precautions and
operating instructions described in this operator’s manual.
11. If the manager for this system is changed, be sure to hand over this operator’s manual to
the new manager.

VI
Introduction
This operator’s manual describes the operating procedures for this diagnostic ultrasound
system. To ensure safe and correct operations, carefully read and understand the manual
before operating the system.
1．Notation Conventions
In this operator’s manual, the following words are used besides the safety precautions (refer
to "Safety Precautions"). Please read this operator’s manual before using the system.
NOTE: Indicates information of interest to users of this system as to
exceptional conditions or operating procedures.
CAUTION:
The diagnostic ultrasound system is not intended for
ophthalmic use. Its use in this clinical specialty is
contraindicated.
2．Operator’s Manuals
The operator’s manuals consist of manuals for the main unit and manuals for transducers.
The English manuals are provided on paper; however, the manuals, which are translated into
languages other than English, are provided in CD (Compact Disc).
1) Manuals on Paper
•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]
Describes measurement preset, measurements and calculations, etc.
•Operator’s Manual [Acoustic Power Data and Surface Temperature Data]
Contains data tables of acoustic output for transducers.
•Operation Note
Contains quick guide for basic operations of the system.

VII
•Operator’s Manuals of Transducers
Describe the operation, cleaning and disinfection procedures for transducers.
2) Manuals in Compact Disc
•Operator’s Manual [Basic Volume]
•Operator’s Manual [Advanced Volume]
•Operation Note
NOTE: 1 The manuals in CD are the manuals translated into
languages other than English according to English manuals.
2 When you find that the contents of the manuals in CD are
NOT consistent with the system or English manuals, please
ONLY refer to the corresponding English manuals.
3 The accompanying manuals may vary depending upon the
specific system you purchased. Please refer to the packing
list.
3．Content of Operator’s Manual
The content of the operator manual, such as screens, menus or descriptions, may be different
from what you see in your system. The content varies depending upon the software version,
options and configuration of the system.

VIII
Safety Precautions
1. Meaning of Signal Words
In this operator’s manual, the signal words DANGER, WARNING,
CAUTION and NOTE are used regarding safety and other important instructions. The
signal words and their meanings are defined as follows. Please understand their meaning
before reading this manual.
Signal word Meaning
DANGER Indicates an imminently hazardous situation that, if not avoided,
will result in death or serious injury.
WARNING Indicates a potentially hazardous situation that, if not avoided,
could result in death or serious injury.
CAUTION Indicates a potentially hazardous situation that, if not avoided,
may result in minor or moderate injury.
NOTE Indicates a potentially hazardous situation that, if not avoided, may
result in property damage.
2. Meaning of Safety Symbols
Symbol Description
Type-BF applied part
The ultrasound transducers connected to this system are Type-BF applied parts.
The ECG module connected to this system is Type-BF applied part.
"Attention" indicates the points that you should pay attention to. Be sure to read the
operator’s manual concerning these points before using the system.

IX
3. Safety Precautions
Please observe the following precautions to ensure patient’s and operator’s safety when using
this system.
DANGER: Do not use flammable gasses, such as anesthetic gas,
oxygen or hydrogen, or flammable liquids such as ethanol,
near this system, because there is danger of explosion.
WARNING: 1 Connect the adapter power plug of this system and
power plugs of the peripherals to wall receptacles that
meet the ratings indicated on the rating nameplate.
Using a multifunctional receptacle may affect the
system grounding performance, and cause the leakage
current to exceed safety requirements. You must use
the power adapter provided with the system; otherwise
electric shock may result.
2 Use the printing cable provided with this system to
connect the printer. Electric shock may result.
3 Connect the grounding conductor before turning ON
the system. Disconnect the grounding cable after
turning OFF the system. Otherwise, electric shock may
result.
4 For the connection of power and grounding, follow the
appropriate procedures described in this operator’s
manual. Otherwise, there is risk of electric shock. Do
not connect the grounding cable to a gas pipe or water
pipe; otherwise improper grounding may result or a gas
explosion may occur.
5 Before cleaning the system, disconnect the power cord
from the outlet. System failure and electric shock may
result.
6 This system is not water-proof. Do not use this system
in any place where water leakage may occur. If any
water is sprayed on or into the system, electric shock
may result. If water is accidentally sprayed on or into
the system, contact Mindray Customer Service
Department or sales representative.

X
7 Store and use the transducers carefully. Do not use a
transducer that has a damaged, scratched surface, or
exposed wiring of any kind. Immediately stop using the
transducer and contact Mindray Customer Service
Department or sales representative.
8 Do not allow the patient to contact the live parts of the
ultrasound system or other devices, e.g. signal I / O
ports. Electric shock may occur.
9 Only use the transducers provided by Mindray.
Otherwise, the system or the transducer may be
damaged, causing a profound failure, e.g. a fire in the
worst case.
10 Do not subject the transducers to knocks or drops. Use
of a defective transducer may cause an electric shock.
11 Do not open the covers and front panel of the system.
Short circuit or electric shock may result when the
system hardware is exposed and powered on.
12 Do not use this system simultaneously with equipment
such as an electrosurgical unit, high-frequency therapy
equipment, or a defibrillator, etc.; otherwise electric
shock may result.
13 Only use the ECG leads provided with the ECG module;
otherwise electric shock may result.
14 When moving the system, you should first fold the LCD
display, disconnect the system from other devices
(including transducers) and disconnect the system
from the power supply.
15 Accessory equipment connected to the analog and
digital interfaces must comply with the relevant IEC
standards (e.g., IEC 60950 information technology
equipment safety standard and IEC 60601-1 medical
equipment standard). Furthermore all configurations
must comply with the standard IEC60601-1-1. It is the
responsibility of the person, who connects additional
equipment to the signal input or output ports and
configures a medical system, to verify that the system
complies with the requirements of IEC60601-1-1. If you
have any questions regarding these requirements,
consult your sales representative.
16 Prolonged and repeated use of keyboards may result in
hand or arm nerve disorders for some individuals.
Observe the local safety or health regulations
concerning the use of keyboards.

XI
CAUTION: 1 Precautions concerning clinical examination
techniques:
1) This system must be used only by qualified
medical professionals.
2) This operator’s manual does not describe clinical
examination techniques. The clinician should
select the proper examination techniques based on
specialized training and clinical experience.
2 Malfunctions due to radio wave:
1) If 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.
2) 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:
1) When you place the system on the mobile trolley
and move them together, you must secure all
objects on the mobile trolley to prevent them from
falling. Otherwise you should separate the system
from the mobile trolley and move them individually.
When you have to move the system with the mobile
trolley upward or downward the stairs, you must
separate them first and then move them
individually.
2) Object placed on the monitor may fall and injure an
individual.
3) Fasten and fully secure any peripheral device
before moving the system. A loose peripheral
device may fall and injure an individual.
4 Do not expose the system to excessive vibration
through transportation. Mechanical damage may result.
5 Do not connect this system to outlets with the same
circuit breakers and fuses that control the current of
devices such as life-support systems. If this system
malfunctions and generates overcurrent, or when there
is an instantaneous current at power ON, the circuit
breakers and fuses of the building’s supply circuit may
be tripped.

XII
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
routine ultrasound examinations. It is possible for the
surface temperature of the transducer to exceed the
body temperature of a patient due to environmental
temperature and exam type combinations. If a patient
complains of any excessive heat from the transducer,
immediately stop scanning. To prevent patient burns,
ensure there is no surface damage to the transducer.
Do not apply the transducer to the same region on the
patient for a long time. Apply the transducer only for a
period of time required for the purpose of diagnosis.
9 The system and its accessories are not disinfected or
sterilized prior to delivery. The operator is responsible
for the cleaning and disinfection of transducers and
sterilization of biopsy brackets according to the
manuals, prior to the use. All items must be thoroughly
processed to completely remove harmful residual
chemicals or gasses that are harmful to the human
body or that may damage the accessory.
10 It is necessary to press [End Exam] to end the current
scan that is in progress and clear the current Patient
Information field. Otherwise new patient data may be
combined with the previous patient data.
11 Do not connect or disconnect the system’s power cord
or its accessories (e.g., a printer or a recorder) without
turning OFF the power first. This may damage the
system and its accessories or cause electric shock.
12 Do not turn OFF the power supply of the system during
printing, file storage or invoking other system
operations. An interrupted process may not be
completed, and can become lost or corrupted.