M5 Operators Manual Basic Volume V 1.0 Dec 2007

© 2007 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All Rights Reserved.

Product Information Product Name: Diagnostic Ultrasound System Model: M5 Issued date of this manual: 2007-12 Version: 1.0

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 copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation or translation of this manual, in any manner whatsoever without the written permission of Mindray, is strictly forbidden.

,

,

,

,

BeneView, WATO, BeneHeart,

are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

I-1

Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor 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;

• The product is used in accordance with the instructions for use.

WARNING:

It is important for the hospital or organization that employs this system to carry out a reasonable service / maintenance plan. Neglect of this may result in machine breakdown or personal injury.

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.

This warranty shall not extend to: z Any Mindray product which has been subjected to misuse, negligence or accident; z Any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed; z Any product of any other manufacturer.

I-2

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 Customer Service Department and obtain a Customer Service 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 system to the address offered by the Customer Service Department.

Company Contact Manufacturer: Address:

Shenzhen Mindray Bio-medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057, P. R. China

Phone:

+86 755 26582479 26582888

Fax:

+86 755 26582934 26582500

EC-Representative: Address:

Shanghai International Holding Corp. GmbH (Europe) Eiffestraβe 80, Hamburg 20537, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

I-3

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.

I-4

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:

CAUTION:

Indicates information of interest to users of this system as to exceptional conditions or operating procedures.

The diagnostic ultrasound system is not intended for ophthalmic use. Its use in this clinical specialty is contraindicated.

I-5

2．

Operator’s Manuals

The operator’s manuals accompanied with this system are divided into those of the main unit and transducers. Operator’s manuals of the main unit

Operator’s transducers

NOTE:

manuals

of

-----

-----

Describe detailed system information on preparation, operating procedures, maintenance checks, and functions. Describe the operating and disinfecting procedures for transducers.

The following manuals are available besides the Basic Volume: 1. Advanced Volume 2. Acoustic Power Data and Surface Temperature Data

3．Screens in This Operator’s Manual Screens or menus may vary depending upon the software version and configuration of each system.

I-6

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. Indicates a potentially hazardous situation that, if not avoided, may result in property damage.

NOTE

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.

S-1

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.

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. 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.

S-2

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

Do not use an aftermarket transducer other than those specified by Mindray. The transducers may damage the system 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 imaging 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

If the grounding wire is questionable, you should disconnect the system with the supply power and stop using the adapter, and change the power supply to internal batteries.

14

Only use the ECG leads provided with the ECG module; otherwise electric shock may result.

15

When moving the system, you should first fold the LCD display, disconnect the system with other devices (including transducers) and disconnect the system with the power supply.

16

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.

17

Prolonged and repeated use of keyboards may result in hand or arm nerve disorders for some individuals. Observe

the

local

safety

or

concerning the use of keyboards.

S-3

health

regulations

CAUTION:

1

Precautions

concerning

clinical

examination

techniques: a)

This system must be used only by qualified

medical professionals. b)

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: a) 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. b) 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: a)

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. b)

Object placed on the monitor may fall and injure an

individual. c)

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 imaging 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.

S-4

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 imaging 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 imaging 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.

11

Do not connect or disconnect the imaging 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.

S-5

13

If the system is powered off improperly during operation, it may result in data damage of the system’s hard disk or system failure.

14

Do not use the system to examine a fetus in the Doppler mode for a long period of time.

15

Do not use a USB memory device (e.g., a USB flash drive, removable hard disk) which has unsafe data. Otherwise system damage may result.

16

It is recommended to only use the peripheral devices specified in this manual.

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.

3

To avoid damaging the system, do not use it in following environment: a) Locations exposed to direct sunlight; b) Locations subject to sudden changes in environmental temperature; c) Dusty locations; d) Locations subject to vibration; e) Locations near heat generators; f) Locations with high humidity.

4

Turn ON the system only after the power has been turned OFF for more than 20 seconds. If the system is turned ON immediately after being turned OFF, the system may not reboot properly and could malfunction.

5

Do not disconnect a transducer that remains in a live imaging state. This can damage the imaging system and / or transducer. Press [Freeze] or turn off the power of the system before connecting or disconnecting a transducer.

6

Remove ultrasound gel from the face of a transducer when the examination is complete. Water in the gel may enter the acoustic lens and adversely affect or damage the transducer array and lens.

S-6

7

You should properly back up the imaging system to a secure external storage media, including system configuration and settings and patient data. Data stored to the imaging system’s hard drive may be lost due to system failure, improper operation or accident.

8

Do not apply external force to the control panel. The system may be damaged.

9

If the system is used in a small room, the room temperature may rise. 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

To ensure optimal imaging system operations, it is recommended that you maintain the system under a Mindray service agreement. Various aspects of system performance and operation can be maintained under the professional supervision of a service representative.

12

The iScape feature constructs a single extended image from a series of individual image frames. The quality of the final image is user-dependent and requires skill to efficiently apply the feature and technique. Exercise caution when measurements are performed from an iScape image.

13

Ensure that the current exam date and time are the same as the system date and time.

NOTE: The following definition of the WEEE label applies to EU member states only: The use of this symbol indicates that this system should not be treated as household waste. By ensuring that this system is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this system, please consult the distributor from whom you purchased the system. * For system products, this label may be attached to the main unit only.

S-7

4.

Latex Alert WARNING:

Allergic reactions in latex (natural rubber) sensitive patients may range from mild skin reactions (irritation) to fatal anaphylactic shock, and may include difficulty in breathing (wheezing), dizziness, shock, swelling of the face, hives, sneezing or itching of the eyes (FDA Medical Alert on latex products, “Allergic Reactions to Latex-containing Medical Devices”, issued on March 29, 1991).

When choosing a transducer cover, it is recommended that you directly contact CIVCO for obtaining transducer cover, pricing information, samples and local distribution information. For CIVCO information, please contact the following: CIVCO Medical Instruments Tel: 1-800-445-6741 WWW.civco.com

S-8

5.

Warning Labels

The warning labels are attached to this system in order to call your attention to potential hazards. on the warning labels indicates safety precautions. The warning labels use

The symbol

the same signal words as those used in the operator’s manual. Refer to the operator’s manual for detailed information about the warning labels. Read operator’s manual carefully before using the system. The name, pattern and meaning of each warning label are described as follows: No.

Label

Meaning

<1>

a)

<2>

b)

c)

The following labels are available when the system works with the mobile trolley.

a)

b)

c)

a) Before using the system, be sure to carefully read the relevant content of this operator’s manual. b) Do not place any object on the keyboard; beware of excessive stress exerted to the keyboard; fold the keyboard when moving the system. c) DANGER: The system must not be used around flammable gasses. There is risk of explosion. a) Before using the system, be sure to carefully read the relevant content of this operator’s manual. b) CAUTION: 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. c) Note: Do not sit on the system.

S-9

Table of Contents 1

2

3

4

5

Overview ...1-1 1.1

Intended Use ... 1-1

1.2

Product and Model Code... 1-1

Product 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

System Configuration...3-1 3.1

Standard Configuration... 3-1

3.2

Transducers Available ... 3-1

3.3

Optional Units ... 3-2

3.4

Peripheral Devices Supported... 3-3

System 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... 4-10

Set-up & Connections...5-1 5.1

System Set-up ... 5-1

5.2

Power Supply ... 5-1

5.2.1 Connecting the External Power Supply ... 5-1 5.2.2 Powered by Batteries ... 5-2 5.3

Connecting / Disconnecting a Transducer ... 5-2

5.3.1 Connect a Transducer... 5-2 5.3.2 Disconnect a Transducer ... 5-3 5.4

Installing the Probe extend module ... 5-3

5.5

Installing IO Extend Module ... 5-4

5.6

Installing the V/A Extend Module... 5-4

5.7

Installing the ECG Module... 5-5

5.8

Installing the Footswitch ... 5-5

5.9

Connecting / Removing a USB Memory Device ... 5-5

5.10

Connecting a Graph / Text Printer ... 5-6

5.11

Connecting a Video Printer ... 5-6 C-1

6

Power ON / OFF...6-1 6.1

Power ON the System... 6-1

6.1.1 Check before Power ON ... 6-1 6.1.2 Turn ON the Power ... 6-2

7

6.2

Power OFF the System ... 6-2

6.3

Restarting the Imaging System ... 6-3

Basic Screen and Operation ...7-1 7.1

Basic Screen ... 7-1

7.1.1 Information Area... 7-1 7.1.2 Image Parameter and Menu Area... 7-2 7.1.3 Thumbnail Area of Magnified Image (Image-in-Image)... 7-3 7.1.4 Image Area ... 7-3 7.1.5 Thumbnail Area of Images Saved ... 7-3 7.1.6 Body Mark Area... 7-3 7.1.7 Area of Help Information and System Status Icon ... 7-3 7.1.8 Soft Menu Area... 7-3 7.1.9 Peripheral Icon Area... 7-4 7.1.10 Measurement Result Area... 7-4 7.2

8

9

Basic Operations of Dialog Boxes... 7-4

Patient Information ...8-1 8.1

Entering / Exiting Patient Information Screen ... 8-1

8.2

Setting Patient Information Display ... 8-1

8.3

Patient Information Input ... 8-2

8.4

Importing Patient Information Worklist ... 8-5

8.5

Searching a Patient ... 8-6

Exam 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 ... 9-2

9.3.1 Exam Selection ... 9-2 9.3.2 Exam Configuration... 9-4 9.3.3 User-defined Exam Types... 9-5

10 Image Modes ...10-1 10.1

Image Modes... 10-1

10.2

Switching Between Image Modes ... 10-2

C-2

10.3

Image Adjustments... 10-3

10.3.1 B Mode ... 10-4 10.3.2 M Mode ... 10-8 10.3.3 Color Mode... 10-10 10.3.4 Power / DirPower Mode ... 10-12 10.3.5 Pulsed Wave Doppler Mode ... 10-13 10.3.6 Image Magnification ... 10-15 10.4

Image Parameter Preset ... 10-15

11 Special Imaging Functions...11-1 11.1

Smart3D ... 11-1

11.1.1 Capture 3D Image ... 11-1 11.1.2 Review 3D Image ... 11-2 11.1.3 Reset ROI... 11-3 11.1.4 Save and Open Images... 11-3 11.1.5 Exit Smart3D ... 11-3 11.1.6 Set Smart3D ... 11-3 11.2

iScape... 11-5

11.2.1 Capture Images ... 11-5 11.2.2 Review iScape Image... 11-5 11.2.3 Cine Review ... 11-7 11.2.4 Save and Open Images... 11-7 11.2.5 Set iScape ... 11-7

12 Cine Review...12-1 12.1

Entering / Exiting Cine Review ... 12-1

12.2

Cine Review in the B / Color Mode ... 12-2

12.2.1 Manual Cine Review ... 12-2 12.2.2 Auto Cine Review... 12-2 12.3

Cine Review in the PW / M Mode ... 12-2

12.4

Linked Cine Review... 12-3

12.5

Setting Region of Auto Review... 12-3

12.6

Save Cine ... 12-4

12.7

Cine Setup... 12-4

12.7.1 Set Cine Length ... 12-4 12.7.2 Set Cine Memory Split... 12-5

13 Measurements ...13-1 C-3

13.1

Basic Operations ... 13-1

13.1.1 Enter Measurement Status... 13-1 13.1.2 Measurement Result and Help Information ... 13-1 13.2

General Measurements... 13-2

13.2.1 General Measurements – 2D ... 13-2 13.2.2 General Measurements - M Mode ... 13-2 13.2.3 General Measurements - Doppler... 13-3 13.3

Application Measurements ... 13-3

14 Comments (Annotations) ...14-1 14.1

Entering / Exiting Comments... 14-1

14.2

Comment Text Library Menu ... 14-1

14.2.1 Comment Text Library Menu ... 14-1 14.2.2 Soft Menu for Comments ... 14-2 14.3

Adding Comments ... 14-2

14.3.1 Type Comment Characters ... 14-2 14.3.2 Add a Comment Text... 14-2 14.3.3 Add an Arrow... 14-3 14.4

Moving Comments... 14-4

14.5

Modifying (Editing) Comments ... 14-4

14.5.1 Modify (Edit) Characters ... 14-4 14.5.2 Modify (Edit) Arrows ... 14-4 14.6

Deleting Comments... 14-5

14.6.1 Delete Comment Characters, Texts or Arrows... 14-5 14.6.2 Delete a Recently-Added Character, Text or Arrow ... 14-5 14.6.3 Delete all Comments (Characters, Texts or Arrows) ... 14-5 14.7

Comment Preset ... 14-6

14.7.1 Font Size and Arrow Size... 14-6 14.7.2 General Comment Texts ... 14-6 14.7.3 User-defined Comments ... 14-8

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

C-4