DP9900 Plus and DP9900 Operator’s Manual Basic V1.6

© 2006-2007 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All Rights Reserved.

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 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, adaption and 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.

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 equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

I-1

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.

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 equipment to the address offered by the Customer Service Department.

I-2

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

Tel:

+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.

The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product.

2.

The warranty does not cover the following items, even during the warranty period: (1) Damage or loss due to misuse or abuse. (2) Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc. (3) Damage or loss caused by failure to meet the specified conditions for this system, such as inadequate power supply, improper installation, or unacceptable environmental conditions. (4) Damage or loss due to use outside the territory in which the system was originally sold. (5) Damage or loss involving system purchased from a source other than Mindray or its authorized agents.

3.

This system shall not be used by persons other than fully qualified and certified medical personnel.

4.

Do not make changes or modifications to the software or hardware of this product.

5.

In no event shall Mindray be liable for problems, damage, or loss caused by relocation, modification, or repair performed by personnel other than those designated by Mindray.

6.

The purpose of this system is to provide physicians with data for clinical diagnosis. The responsibility for diagnostic procedures lies with the physicians involved. Mindray shall not be liable for the results of diagnostic procedures.

7.

Important data must be backed up on external recording media such as clinical records, notebooks etc.

8.

Mindray shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents.

9.

This manual contains Warnings regarding foreseeable potential dangers. Be alert at all times to dangers other than those indicated. Mindray shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions contained in this operator’s manual.

10.

On the occasion of change of the administrator or manager for this system, be sure to hand over this operator’s manual.

I-4

Product Information Product Name: Digital Ultrasonic Diagnostic Imaging System Model: DP-9900/DP-9900Plus/DP-9600 Issued date of this manual: 2007-11 Version: 1.6

I-5

Introduction This operator’s manual describes the functions and applications of the system. To ensure safe and correct operation of the system, carefully read and understand the manual before operating the system.

The functions described in operator’s manuals of this system, are not provided for all models sold in all regions. What functions are available depends on specific system you purchased. All figures in this manual are only for reference. What some figures show may be different from the system you purchased.

1. Operator’s Manuals A Mindray service person or instructor will explain the basic operating procedures for this system at the time of delivery. However, read this operator’s manual carefully before using the system in order to understand the detailed operating procedures, functions, performance, and maintenance procedures. The organization of the documents supplied with this system is shown below: Operator’s manuals of the main unit (including basic volume and advanced volume)

‹

Describe

detailed

system

information

on

preparation,

operating

procedures,

maintenance checks, and functions. Operator’s manuals of transducers

‹

Describe the operating and disinfection procedures for transducers.

2. Interfaces in This Operator’s Manual Depending on the software version and configuration of each system, interfaces or menus may appear different from those shown in this manual.

IMPORTANT! 1.

No part of this manual may be copied or reprinted, in whole or in part, without written permission.

2.

The contents of this manual are subject to change without prior notice and without our legal obligation.

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 meanings clearly before reading this manual. Signal word

Meaning Indicates an imminently hazardous situation which, if not

DANGER

avoided, will result in death or serious injury.

WARNING CAUTION NOTE

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Indicates a potentially hazardous situation which, if not avoided, may result in property damage.

2.

Meaning of Safety Symbols Symbol

Description Type-BF applied part All ultrasound transducers can be connected to this system are Type-BF applied part. "Attention" indicates the points requiring attention. Be sure to read the operator’s manual concerning these points before using the equipment.

S-1

3.

Safety Precautions

Please observe the following precautions to ensure patient and operator 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 product, because there is danger of explosion.

WARNING: 1． Do connect the plug of this equipment to the wall receptacle meeting the ratings indicated on the rating nameplate. The video printer must be connected to the designated AC outlet. （Please refer to chapter 4） Using adapter or multi-functional receptacle may affect the system’s grounding performance and thus cause leakage current exceeding safety requirement. 2． Be sure to connect the potential-equalization lead wire before inserting the equipment power plug into the receptacle and be sure to remove the equipment power plug from the receptacle before disconnecting the wire, in order to avoid electrical shock. 3． Connect the earth conductor only before turning ON the system. Disconnect the grounding cable only 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 installation manual. Otherwise, there is risk of electric shock. Do not connect the grounding cable to a gas pipe or water pipe, otherwise functional grounding may not be effective or there may be risk of a gas explosion. 5． Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as life-support systems.

If this system malfunctions and generates an overcurrent,

or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped.

S-2

6． No waterproof device is applied to this equipment. Do not use this equipment in any place with the possibility of water ingress. There is risk of electric shock if any water is sprayed on or into the equipment. If you carelessly spray any water onto/into the equipment contact the Mindray sales office, customer service department or representative. 7． Use the transducer carefully. In case that the human body contacts the scratched transducer surface, immediately stop using the transducer and contact the Mindray sales office, customer service department or representative. There is risk of electric shock if using the scratched transducer. 8． After the sterilization or disinfection of accessories, chemicals must be washed out thoroughly from the accessories. Remaining residual chemicals will not only result in damage to the accessories but also be harmful to human bodies. 9． Be careful not to let the patient contact the ultrasound equipment. If the ultrasound equipment is defective, there is risk of electric shock. 10. Do not subject the equipment to excessive shock such as when moving the equipment, otherwise mechanical parts such as the casters may be damaged. If the equipment is moved over a bumpy floor frequently, contact the Mindray sales office, customer service department or representative. 11. Do not use the transducers other than those specified in this manual. If a transducer other than those specified in this manual is connected, the equipment and the transducer may be damaged, causing an accident such as a fire in the worst case. 12. Do not subject the transducers to knocks. Use of defective transducers may cause an electric shock. 13. Do not open the shell or front panel. If open the shell when the machine is powered on, there may be a short circuit or electric shock. 14. Do not use the equipment at the same time use equipment such as an electric scalpel, high-frequency therapy equipment or a defibrillator, etc. In addition, do not allow ultrasonic transducers to come into contact with the patient. The patient may be burned or injured by an electric shock. 15. Precautions during transportation: When moving the equipment, hold the handle. If the user holds other sections, the equipment may be subject to unnatural force and may be damaged. Do not move the equipment in the left/right direction. If the equipment is moved in the left/right direction, the equipment may fall. 16. Prolonged and repeated use of keyboards can result in hand or arm nerve disorders in some individuals. Observe the local institution work safety/health regulations on keyboard use. S-3

17. Accessory equipments connected to the analogue and digital interfaces must be complied with the relevant IEC standards. Furthermore all configurations should comply with the standard IEC60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of IEC60601-1-1. If in doubt, consult Mindray customer service department or your local distributor.

CAUTION: 1．Precautions concerning clinical examination techniques (1) This system must be used only by medical personnel fully trained in clinical examination techniques. (2) This operator’s manual does not describe clinical examination techniques. Selection of the proper clinical examination technique must be based on specialized training and clinical experience. 2．Malfunctions due to radiowaves (1) Use of radiowave-emitting devices in the proximity of this kind of medical electronic system may interfere with its operation.

Do not bring or use devices which generate radio

waves, such as cellular telephones, transceivers, and radio controlled toys, in the room where the system is installed. (2) If a user brings a device which generates radio waves near the system, they must be instructed to immediately turn OFF the device. This is necessary to ensure the proper operation of the system。 3． Precautions concerning installation and movement of the system (1) Be sure to install the system on a level floor and lock the casters. Otherwise, the system may move, and injure the patient. (2) Do not push the system from the sides. If the system is pushed from the side, it may fall down and cause injury.

S-4

(3) When the system is moved over a sloped surface, it must be moved slowly by two persons. Otherwise, the system may slide unexpectedly and cause a serious injury. (4) Do not sit on the system. The system may move, causing you to lose your balance and fall. (5) Do not place any objects on top of the monitor. They may fall, causing injury. (6) Confirm that the peripheral units are secured before you move the system.

Otherwise, the peripheral units may fall and

cause injury. (7) When the system is moved over a step, be careful not to allow the system to fall. When holding the system at the bottom to help move it over a step, take special care to prevent hand injuries. 4． Be sure to supply power to video printer from the outlet provided on this equipment. For electrical safety, do not connect to an external outlet. In addition, be sure to use the cable supplied with the system to connect a printer. If a different cable is used, there is a risk of electric shock. 5． Always keep the machine dry. Avoid transporting this machine quickly from the cold place to the warm place, otherwise condensation or water drops may be formed, which will cause short circuit. 6． If the circuit breaker is tripped or the fuse is blown, it indicates that the machine or the peripheral devices have problems. In these cases, the user cannot repair by him but contact the Mindray sales office, customer service department or representative. 7． There is no risk of high-temperature burns during routine ultrasound examinations. To prevent high-temperature burns, do not apply the transducer to the same spot on the patient for a long time. Apply the transducer only for as long as required time for diagnosis. 8． Before cleaning the system, be sure to disconnect the power cable from the outlet. If the system is defective, there is a risk of electric shock.

S-5

9．Before examining a new patient, press 『Patient』 to delete the patient information and data recorded in the memory for the previous patient. Otherwise, the new data may be confused with the data of the previous patient. 10. When the system is turned OFF or 『Patient』 is pressed, all the measured data are lost. (If obstetric measurement data have been saved, they are in obstetric history report.) 11. When a CIN or FRM file is opened, the current patient information as well as the measurement data and image file of the patient will be cleared. Then the system will set the patient that is related to the CIN or FRM file as the current patient. 12. After you open a CIN or FRM file, unfreezing the image will clear up all comments,

general

measurements,

BodyMarks

and

patient

information. 13. Press 『Clear』 key, all comments, BodyMarks, measurements scale and general measurement data on the screen will be cleared up. 14. Do not pull out plugs of the system and its accessories without turning OFF the power. Otherwise it may result in equipment damage or even electric shock. 15. Do not turn OFF the power supply of the system during printing, saving, or invoking. Otherwise it may result in abnormality of these processes or damage the hard disk. 16. Please use the USB storage device compliant with the relevant local regulations. The format of the USB storage device file system should be FAT or FAT32, and the instruction is SCSI. 17. Some USB portable hard disks must be connected to the external power（the external power must be compliant with the relevant local regulations）, otherwise they can not be distinguished. 18. Use ultrasound gel complying with local regulations.

S-6

NOTE:

1. Do not use the machine in the vicinity of strong electromagnetic field (such as the transformer), which may affect the performance of the monitor. 2. Do not use the machine in the vicinity of high-frequency radiation source (such as the cellular phone), which may affect the performance of the machine or even lead to failure. 3. To avoid damaging the machine, do not use the machine in following environment: (1) Locations exposed to direct sunlight; (2) Locations subject to sudden changes in 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 OFF for more than 5 seconds. If the system is turned ON immediately after being turned OFF, it may result in malfunction of the system. 5. Turn OFF the system or stop transmission (freeze) before connecting or disconnecting a transducer. If a transducer is connected or disconnected with an image displayed, it may result in malfunction of the system and/or the transducer. 6. After using the transducer, remove the gel on it. Otherwise, water in the gel may enter the acoustic lens, thus adversely affecting the performance and safety of the transducer. 7. To ensure the safety of the data, be sure to back up the data stored in the system on external storage media. Since the data stored in the system may be lost due to improper operation or an accident. 8. Do not subject the control panel to excessive force, such as by leaning on it. Otherwise, the equipment may be damaged. 9. If this equipment is used in a small room, the room temperature may rise. Proper ventilation must be provided. 10. The fuse inside the machine can be replaced only by the Mindray service engineer or the technician specified by Mindray.

S-7

11. When disposing of this system or any part of the system, contact Mindray sales office, customer service department or representative. Do not dispose of this system without consulting Mindray sales office, customer service department or representative first. Mindray does not assume any responsibility for damage resulting from disposal of this system without consulting Mindray。 12. Deterioration of electrical and mechanical safety characteristics (such as generation of a leakage current or deformation/abrasion of mechanical parts) and of image sensitivity and resolution may occur over a period of time. Check and maintenance the system periodically. To ensure system performance, signing a maintenance and service contract to avoid accidents and misdiagnose is recommended. 13. The output power outlets on the main unit are used for providing power to recommended external optional devices. Do not connect other devices to the outlets otherwise the output power may be exceeded and the equipment may malfunction. The output of the auxiliary power supply is 100-240V～ 50/60Hz 1.5/0.8A. 14. Do not connect equipments other than specified in this manual to the system. 15. Be sure to use the system under the circumstances specified in this manual.

NOTE: The following definition of the WEEE label applies to EU member states only: The use of this symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of

correctly,

you

will

help

prevent

bringing

potential

negative

consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased the product. * For system products, this label may be attached to the main unit only.

S-8

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 March 29, 1991)

Therefore, when choosing the transducer cover, we recommend that the user contact CIVCO directly 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-9

5.

WARNING Labels

Various WARNING labels are attached to this system in order to call the user's attention to potential hazards. The symbol

on the WARNING labels attached to the system indicates safety precautions.

The name, appearance, and the indication of each WARNING label is as follows. Read them carefully and understand them. No.

Label

Meaning

<1>

Cautions against sitting on the system.

<2>

(a) Cautions that the system must not be used around flammable gasses. (b) Urges Caution related to handling of the transducers. For handling of the transducers, refer to the operator’s manuals of transducers.

<3>

(a) Cautions that the system must be placed on a horizontal surface. (b) Cautions that the system must not be removed covers because the high voltage may cause electric shock.

S-10

Contents

1

Intended Use ...1-1

2

Specifications...2-1

3

4

5

2.1

Conditions... 2-1

2.2

External Dimensions and Weight... 2-1

System Configuration...3-1 3.1

Basic Configuration... 3-1

3.2

Optional Units ... 3-1

3.3

Optional Transducers... 3-1

3.4

Peripheral Devices... 3-2

System Overview ...4-1 4.1

Parts ... 4-1

4.2

Rear Panel... 4-3

4.3

Control Panel ... 4-5

4.4

Symbols ... 4-8

Preparation for Examination ...5-1 5.1

Moving and Placing the System... 5-1

5.2

Connect/Disconnect the Transducer... 5-1

5.2.1 Connecting the Transducer... 5-2 5.2.2 Disconnecting the transducer ... 5-2 5.3

Connecting the Power Cable and Protective Earth... 5-2

5.3.1 Power connection ... 5-2 5.3.2 Grounding terminal ... 5-3 5.3.3 Equipotential terminal ... 5-3 5.4

Connecting Printers ... 5-4

5.4.1 Connecting the video printer ... 5-4 5.4.2 Connecting the graph/text printer... 5-4

6

Power ON/OFF...6-1 6.1

Power On... 6-1

6.1.1 Check the items below before turning ON the power... 6-1 6.1.2 Turning on the power ... 6-1 6.2

Power OFF ... 6-2

C-1

6.3

7

8

Power OFF/ON in the System Failure ... 6-2

Checks ...7-1 7.1

Checks before Power on ... 7-1

7.2

Checks after Power ON ... 7-2

Basic Interface and Menu...8-1 8.1

Interface... 8-1

8.2

Image Mode... 8-2

8.3

Menu and Menu Types ... 8-4

8.3.1 Command menu items... 8-4 8.3.2 Number menu items ... 8-4 8.3.3 Switch menu items... 8-5 8.3.4 Character menu items ... 8-5 8.3.5 Submenu Items... 8-5 8.4

9

Dialog Box ... 8-6

Starting Examination ...9-1 9.1

Selecting Exam Mode... 9-1

9.2

Entering Patient Information ... 9-1

9.3

Searching/Changing Patient Data... 9-2

9.4

Worklist ... 9-3

10 Presets ...10-1 10.1 Introduction ... 10-1 10.2 Entering/Exiting Preset Mode ... 10-1 10.2.1 Entering preset mode ... 10-1 10.2.2 Exiting preset mode ... 10-2 10.3 Displaying/Modifying Preset Information... 10-2 10.3.1 Modifying preset information... 10-2 10.3.2 Special function button... 10-3

11 Image Control and Adjustment ... 11-1 11.1 Adjusting Image Parameters... 11-1 11.1.1 B/M gain... 11-1 11.1.2 Acoustic power... 11-2 11.1.3 Transducer frequency ... 11-2 11.1.4 TGC ... 11-2 11.1.5 Number of focuses ... 11-3 11.1.6 Focus position... 11-3

C-2

11.1.7 Depth ... 11-4 11.1.8 Dynamic range... 11-4 11.1.9 Edge enhancement ... 11-4 11.1.10 Frame average... 11-5 11.1.11 M soften... 11-5 11.1.12 B AGC ... 11-5 11.1.13 Tissue specific imaging (TSI) ... 11-5 11.1.14 M speed ... 11-5 11.1.15 Scan mode... 11-6 11.1.16 Post processing ... 11-6 11.1.17 IP... 11-8 11.2 Zoom ... 11-9 11.3 Image Reversal... 11-10 11.4 Images Merge... 11-10

12 Cine ...12-1 12.1 Introduction ... 12-1 12.2 Cine Review in B Mode ... 12-2 12.2.1 Manual review... 12-2 12.2.2 Auto review ... 12-2 12.3 Cine Review in M Mode... 12-3 12.4 Others ... 12-4

13 Adding/Deleting Comments ...13-1 13.1 Entering/Exiting Comment Status ... 13-1 13.2 Adding Comments from Keyboard ... 13-1 13.3 Adding Comments from Comment Library... 13-2 13.4 Adding Arrows... 13-3 13.5 Moving Comments ... 13-3 13.6 Modifying Comments ... 13-4 13.7 Deleting Comments ... 13-4 13.7.1 Deleting characters... 13-4 13.7.2 Deleting arrows... 13-4 13.7.3 Deleting all comments and arrows ... 13-4 13.8 Comment Library ... 13-5

14 Body Mark...14-1 14.1 Introduction ... 14-1

C-3