DP-3300 Operation Manual Basic Volume

© 2005-2006 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.

Product Information Product Name: Digital Ultrasonic Diagnostic Imaging System Model: DP-3300 Issued date of this manual: 2006-02 Version: 1.2

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 whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaptation and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, , , , 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.

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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 safety, reliability and performance of this product only in the condition that:

• 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 injury of human health.

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: 

any Mindray product which has been subjected to misuse, negligence or accident;



any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed;



any product of any other manufacturer.

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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. Obtain return authorization: Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Returned shipments will not be accepted if the Mindray 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 Customer Service department

Company Contact Manufacture: Address:

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

Phone:

+86 755 26582479 26582888

Fax:

+86 755 26582500 26582501

ECRepresentative: Address:

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

Phone:

0049-40-2513175

Fax:

0049-40-255726

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Important Information 1. 2.

3. 4. 5. 6.

7. 8. 9.

10.

The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product. 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. This system shall not be used by persons other than fully qualified and certified medical personnel. Do not make changes or modifications to the software or hardware of this product. 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. 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. Important data must be backed up on external recording media such as clinical records, notebooks etc. Mindray shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents. 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 operation manual. On the occasion of change of the administrator or manager for this system, be sure to hand over this operation manual.

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Introduction This operation manual describes the operating procedures for the diagnostic ultrasonic imaging system DP-3300. To ensure safe and correct operation of the system, carefully read and understand the manual before operating the system.

1. Notation Conventions In this operation manual, the following words are used in addition to the signal words related to the safety precautions (refer to "Safety Precautions"). Please read this operation manual before using the system. NOTE:

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

2. Operation Manuals A Mindray service person or instructor will explain the basic operating procedures for this system at the time of delivery. However, read this operation 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: Main unit operation manual

Describes detailed system information on preparation, operating procedures, maintenance checks, and functions.

Transducer manuals

Describe the operating and sterilization procedures for transducers.

operation

NOTE: For certain applications, the following manuals are available: • (Advanced Volume)

3. Interface in This Operation Manual This operation manual takes the ultrasonic diagnostic imaging system with the highest configuration as an example to fully and systematically introduce the functions and applications of the system. Since there are differences among different configurations, what this manual introduces may be different from the ultrasonic diagnostic imaging system you purchased.

IMPORTANT! 1. 2.

No part of this manual may be copied or reprinted, in whole or in part, without written permission. The contents of this manual are subject to change without prior notice and without our legal obligation. I-5

Safety Precautions 1.

Meaning of Signal Words

In this operation 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

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTE

2.

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

Meaning of Safety Symbols Symbol

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

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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 and its peripheral equipments to the wall receptacle meeting the rating nameplate. Using adapter or multi-functional receptacle may affect system grounding performance and thus cause leakage current exceeding safety requirement. Please use the supplied power cable. No other power cables should be used. 2． Be sure to connect the potential-equalization lead wire before inserting the equipment power plug into the receptacle. Also, be sure to remove the equipment power plug from the receptacle before disconnecting the wire 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 operation 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. 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 carelessly spray any water onto the equipment contact the Mindray sales office, customer service department or representative. 7． Use the transducer carefully. In case that the 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 must be discharged thoroughly from the accessories. Remaining residual chemicals or gases will not only result in damage to the accessories but also can be harmful to human bodies. 9． Do not allow this system or other equipment to come into contact with the patient. If this system or other equipment is defective, the patient may receive an electric shock.

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10. Do not use the transducers other than those specified by Mindray. If a transducer other than those specified by Mindray is connected, the equipment and the transducer may be damaged, causing an accident such as a fire in the worst case. 11. Do not subject the transducers to knocks. Use of defective transducers may cause an electric shock. 12. 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. 13. Do not use this system at the same time with other equipment such as electric knife, high-frequency therapy equipment and defibrillator, etc., Otherwise there is a danger of electric shock. 14. Precautions during transportation: When moving the equipment, first turn it off and close up the keyboard, then disconnect it with other devices(including transducer), disconnect it with power supply, and wrap the power cable on the winding rack, finally lift it carefully by handle and move it to a proper position. 15. 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. 16. Accessory equipment 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. Anyone 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 the technical services department of your local representative.

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 operation 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) Do not place any objects on top of the system. They may fall, causing injury.

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(2) Confirm that the peripheral units are secured before moving the system. Otherwise, the peripheral units may fall and cause injury. 4 ． Please use the supplied or recommended peripheral devices and optional parts. Please use the supplied cables. Using other devices or cables may degrade the system performance and even cause an electrical 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. 9 ． Before examining a new patient, press [Patient] key to delete the patient information and data recorded in the image memory for the previous patient. Otherwise, the new data may be confused with the data of the previous patient. 10. Do not pull out the system and its accessories plug without turn OFF the power. Doing so may cause these equipment damaged even electric shock. 11. Do not turn OFF the power supply of the system during printing, saving, or invoking. Otherwise it may result in abnormality of these processes. 12. 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. 13. Press SHIFT + DEL key, all comments, bodymarks, measurement scales and general measurement data on the screen will be cleared up. 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

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(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, the system may malfunction. 5. Turn OFF the system or stop transmission by [FREEZE] key before connecting or disconnecting a transducer. Otherwise, it may result in malfunction of the system and/or the transducer. 6. After using the transducer, remove the gel (acoustic coupler) on it and place the transducer on the transducer holder. Otherwise, water in the gel may enter the acoustic lens, thus adversely affecting the performance and safety of the transducer. 7. The user can record patient data (including hospital data and patient data). To ensure the security of the data, be sure to back up the data on external storage media. Data stored in the equipment may be lost due to improper operation or an accident. 8. If this equipment is used in a small room, the room temperature may rise. Proper ventilation must be provided. 9. The fuse inside the machine can be replaced only by the Mindray service engineer or the technician specified by MINDRAY. 10. Do not turn OFF the system during printing, saving, or invoking. Otherwise may cause these processes to not operate correctly. 11. 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 12. 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 may not be distinguished. 13. 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。 14. 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. To guarantee the normal performance of the equipment, it is proposed to enter into an agreement on maintenance and service to prevent accident. 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.

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4.

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 WARNING labels use the same signal words as used in the descriptions in the operation manuals. Detailed information about the WARNING labels is given in the main body of this operation manual. Read the operation manual carefully before using the system. The name, appearance, and the indication of each WARNING label are shown as follows. No.

Label

Meaning

<1>

Cautions that no object or force or any stress is added on keyboard. Close up the keyboard before moving the equipment.

<2>

(a) Cautions that the system must not be used around flammable gasses, otherwise there may be risk of explosion. (b) Urges Caution related to handling of the transducers. For handling of the transducers, refer to the transducers’ operation manual.

<3>

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

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Contents Contents ...1 1 Intended Use...1 2 Specifications...1 2.1 Conditions...1 2.2 External dimensions and mass...1 3 System Configuration...1 3.1 Basic Configuration...1 3.2 Available Transducers...1 3.3 Optional Parts...1 3.4 Peripheral Devices...2 4 System Overview...1 4.1 Name of Each Part...1 4.2 Rear panel...3 4.3 Control Panel...4 4.4 Symbols...5 5 Preparation for Examination...1 5.1 Moving and Placing the System...1 5.2 Connect/Disconnect the Transducer...1 5.2.1 Connecting the Transducer...1 5.2.2 Disconnecting the transducer...2 5.3 Connecting the Power Cable and Protective Earth...2 5.3.1 Power connection...2 5.3.2 Grounding Terminal...2 5.3.3 Equipotential Terminal...3 5.4 Connecting printers...3 5.4.1 Connecting the video printer...3 5.4.2 Connecting the graph/text printer...3 6 Power ON/OFF...1 6.1 Power On...1 6.1.1 Check the items below before turning the power ON...1 6.1.2 Turning On the Power...1 6.2 Power OFF...2 6.3 Power OFF/ON in the case of system failure...2 7 Checks Before and After Use...1 7.1 Checks before use...1 7.2 Checks after Use...2 8 Basic Screen and Menu...1 8.1 Display of Parameter Items...1 8.2 Image Mode...2 8.3 Menu and Menu Options...3 8.3.1 Command Items...3 8.3.2 Number Items...4 C-1

8.3.3 Switch Items...4 8.3.4 Character Items...5 8.3.5 Submenu Items...5 8.4 Dialog Box...5 8.4.1 Operation for content of dialogue box...6 8.4.2 Changing page...6 8.4.3 Dragging the dialogue box...6 8.4.4 Confirm or cancel operation, and close dialogue box...7 9 Examination Beginning...1 9.1 Selecting the Exam Mode...1 9.2 Entering the Patient Information...1 10 Presets...1 10.1 Introduction...1 10.2 Enter/Exit Preset Mode...1 10.2.1 Enter the preset mode:...1 10.2.2 Exit Preset mode:...1 10.3 Display/Modify Preset Information...1 10.3.1 Procedures to modify the preset values...1 11 Image Control and Adjustment...1 11.1 B/M Gain...1 11.2 Acoustic Power...2 11.3 TGC...2 11.4 IP 3 11.5 Transducer Frequency...3 11.6 Focus position and Focus number...3 11.6.1 Adjusting the position of focus...4 11.6.2 Adjusting the number of focuses...4 11.7 Image Zoom and Depth...4 11.7.1 Zoom...4 11.7.2 Depth...5 11.8 Image Reverse...5 11.9 Dynamic Range...5 11.10 Edge Enhancement...6 11.11 Smooth ...6 11.12 Frame Average...6 11.13 M Speed...6 11.14 Scan line density ...6 11.15 Gray map ...7 12 Cine Review Function...1 12.1 Introduction...1 12.2 Cine Review...1 12.2.1 Manual Review...1 12.2.2 Auto Review...1 12.2.3 Others...2 13 Entry and Deletion of Comments...1 13.1 Enter/Exit Comment Status...1 C-2

13.2 Input Comments from the Keyboard...1 13.3 Input Comments from Comment Library...1 13.4 Input Arrow Comment...2 13.5 Move Existing Comment Items...2 13.6 Modifying the Comments...2 13.7 Deletion of Comment...3 13.7.1 Delete characters...3 13.7.2 Delete arrows...3 13.7.3 Delete all comments and arrows...3 13.7.4 Delete Items in Reverse Sequence...3 13.8 Comment library...3 14 Body Mark...1 14.1 Introduction...1 14.2 Enter/Exit the Body Mark mode...2 14.3 Add Body Mark...2 14.4 Moving Body Mark...3 14.5 Clearing Body Mark...3 15 Measurements and Calculations...1 15.1 Basic Operation...1 15.1.1 Enter Measurement Status...1 15.1.2 Measurement Menu...1 15.1.3 Measured Result and Help Information...2 15.1.4 Keys Used in Measurement...3 15.1.5 Classification of Measurements and Calculations...3 15.2 B-mode Measurements...3 15.3 M-mode Measurements...4 16 File System...1 16.1 General...1 16.1.1 Storage Medium...1 16.1.2 File Menu...1 16.2 Default Path and Default File Naming Rule...1 16.2.1 Setting the default path...1 16.2.2 Naming rule of default filename...2 16.3 Saving/Opening a File...2 16.3.1 Quick saving a file...2 16.3.2 General saving a file...3 16.3.3 Opening a file...4 16.4 DICOM...5 16.4.1 Sending the DCM images...5 16.4.2 Sending the DCM files...6 16.5 File Management...6 16.5.1 Directory management...6 16.5.2 File management...8 16.6 Disconnect USB Storage Device Safely...9 17 Needle Guide...11 17.1 Enter/Exit Needle Guide Mode...11 C-3

17.2 Select the Angle of Needle Guide Line...11 17.3 Hide/Display Needle Guide Lines...11 17.4 Adjust Needle Guide Line...12 18 Acoustic Power Principle...1 18.1 Concerns with Bioeffects...1 18.2 Prudent Use Statement...1 18.3 ALARA (As Low As Reasonably Achievable)...1 18.4 Parameters Affecting Acoustic Power...1 18.5 Acoustic Power Setting...1 18.6 Imaging functions that change acoustic output power...2 18.7 References for Acoustic Power and Safety...2 19 Maintenance Check...1 19.1 Maintenance Checks to Be Carried Out by Customers...1 19.1.1 Cleaning the system...1 19.1.2 Creating a backup copy of the system hard disk...2 19.2 Maintenance Checks to Be Carried Out by Service...2 19.3 Consumable Parts and Parts Requiring Periodic Replacement...2 19.4 Troubleshooting...2 20 Accuracy of Measurement...1 21 Safety Classification...1 22 Guidance and Manufacturer's Declaration...1 23 Indication of Year of Manufacture...1

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1

Intended Use

The DP-3300 digital ultrasonic diagnostic imaging system can be used in whole body including abdomen, gynecology, obstetrics, small organs (breast, thyroid, testes, etc.) ultrasonic examinations.

Contraindication: none.

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2

Specifications

2.1 Conditions (1) Power Line voltage

:

100－240 V～

Line frequency

:

50 / 60Hz

Power consumption

:

150 VA

(2) Operating environmental conditions Ambient temperature

:

5°C to 40°C

Relative humidity

:

35% to 85% (no condensation)

Atmospheric pressure

:

700 hPa to 1060 hPa

(3) Storage and transportation conditions Ambient temperature

:

-20°C to 55°C

Relative humidity

:

30% to 85% (no condensation)

Atmospheric pressure

:

700 hPa to 1060 hPa

NOTE: The line voltage differs depending on the area.

2.2 External dimensions and mass (a) External dimensions (excluding handle, winding rack, wire hanging rack, etc): 265mm broad × 410 mm length × 330 mm height (b) Mass (excluding optional units): Approx. 12 kg

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3

System Configuration

3.1 Basic Configuration (1) Main unit (2) Standard transducer (3) Accessories

3.2 Available Transducers Transducer model

Intended use

Applicable parts

35C50EB

Abdomen, pediatrics, gynecology and obstetrics examinations

Body surface

65EC10EB

Gynecology , examinations

urology

Transvaginal, Transrectal

75L38EB

Small organs (breast, thyroid, testes, etc.), neonatal cephalic, peripheral vascular, muscular-skeletal (conventional, superficial)

Body surface

65C15EA

Pediatric abdomen and head

Body surface

75L60EA

Small organs (breast, thyroid, testes, etc.), neonatal cephalic, peripheral vascular, muscular-skeletal (conventional, superficial)

Body surface

obstetrics

and

3.3 Optional Parts No.

Name

Model

1

Mobile Trolley

UMT-100

2

DICOM Software

DICOM3.0

3

Double transducer ports

/

4

Needle guide software

/

1

Accuracy of Measurement

3.4 Peripheral Devices No. 1

Name Video printer

Model SONY UP-895MD SONY UP-897MD

2

Graph/text printer(USB port)

MITSUBISHI P93W HP DeskJet 5652/5650 Business Inkjet 1200 HP Laserjet2420d HP DeskJet6548

2