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DP-8500
Operator's Manual
101 pgs1.27 Mb0
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Mindray DP-8500, DP-8300 Operator's Manual

DP-8500/DP-8300
Digital Ultrasonic Diagnostic
Imaging System
Operator’s Manual
[Basic Volume]

Contents

Intellectual Property Statement .......................................................................................................... I
Responsibility on the Manufacturer Party .......................................................................................... I
Warranty ............................................................................................................................................ II
Return Policy .................................................................................................................................... III
Important Information ....................................................................................................................... IV
About This Manual ........................................................................................................................... IV
Notation Conventions ....................................................................................................................... IV
Operator’s Manuals ........................................................................................................................... V
Manuals on Paper ............................................................................................................................. V
Software Interfaces in this Manual .................................................................................................... V
Conventions ...................................................................................................................................... V
Safety Precautions .............................................................................................................. VI
Meaning of Signal Words ................................................................................................................. VI
Meaning of Safety Symbols.............................................................................................................. VI
Safety Precautions ........................................................................................................................... VI
Latex Alert ......................................................................................................................................... X
Warning Labels ................................................................................................................................. XI
1 Overview ...................................................................................................................... 1-1
1.1 General ................................................................................................................................. 1-1
1.2 Product Specifications .......................................................................................................... 1-1
1.3 System Configuration ........................................................................................................... 1-2
1.4 System Introduction .............................................................................................................. 1-3
Contents i
2 Preparing the System ................................................................................................. 2-1
2.1 Setup and Connections ........................................................................................................ 2-1
2.1.1 Moving and Placing the System ................................................................................... 2-1
2.1.2 Connecting the Power Cord .......................................................................................... 2-1
2.1.3 Connecting/Disconnecting the Transducers ................................................................. 2-2
2.1.4 Connecting/Disconnecting USB device ........................................................................ 2-3
2.1.5 Connecting a Footswitch ............................................................................................... 2-3
2.1.6 Connecting a Printer ..................................................................................................... 2-3
2.1.7 Connecting an External Display .................................................................................... 2-4
2.2 Powering ON/OFF ................................................................................................................ 2-4
2.2.1 Checking before Powering ON ..................................................................................... 2-4
2.2.2 Powering ON ................................................................................................................. 2-5
2.2.3 Restarting ...................................................................................................................... 2-5
2.2.4 Powering OFF ............................................................................................................... 2-6
2.3 Main Interface ....................................................................................................................... 2-6
2.4 Basic Operations .................................................................................................................. 2-7
3 Beginning an Exam ..................................................................................................... 3-1
3.1 Entering Patient Information ................................................................................................. 3-1
3.2 Get Patient Information ........................................................................................................ 3-2
3.2.1 iStation .......................................................................................................................... 3-2
3.2.2 Work List ....................................................................................................................... 3-3
3.3 Selecting the Exam Mode .................................................................................................... 3-3
3.4 Selecting the Image Mode .................................................................................................... 3-3
3.5 Adjusting the Image .............................................................................................................. 3-4
3.5.1 Zooming ........................................................................................................................ 3-4
3.5.2 Zooming with Thumbnail ............................................................................................... 3-4
3.5.3 Rotating and Flipping the Image ................................................................................... 3-5
3.5.4 Image Merge ................................................................................................................. 3-5
3.6 Cine Review ......................................................................................................................... 3-5
3.6.1 Cine Review of B Mode ................................................................................................ 3-6
3.6.2 Cine Review of 2B/4B Mode ......................................................................................... 3-7
3.6.3 Cine Review of M/M+B Mode ....................................................................................... 3-7
3.7 Brief Introductions to Measurement ..................................................................................... 3-7
3.7.1 Basic Operations and Buttons ...................................................................................... 3-7
3.7.2 Measurement Items ...................................................................................................... 3-8
4 Optimizing the Image .................................................................................................. 4-1
4.1 Basic Operations .................................................................................................................. 4-1
4.2 B Mode ................................................................................................................................. 4-2
4.2.1 Depth ............................................................................................................................ 4-2
ii Contents
4.3 M Mode ................................................................................................................................ 4-8
5 Annotating the Image ................................................................................................. 5-1
5.1 Comments ............................................................................................................................ 5-1
5.2 Body Mark ............................................................................................................................ 5-2
6 Auxiliary Functions .................................................................................................... 6-1
6.1 Biopsy Guide ........................................................................................................................ 6-1
6.2 Lithotrity ................................................................................................................................ 6-2
7 File Management ......................................................................................................... 7-1
7.1 Formats of Files .................................................................................................................... 7-1
7.2 Saving Files .......................................................................................................................... 7-1
7.3 File Management .................................................................................................................. 7-1
7.4 Backup ................................................................................................................................. 7-2
Contents iii
7.4.1 Backup of Data ............................................................................................................. 7-2
7.4.2 Erasing Optical Disc ...................................................................................................... 7-3
7.5 iVision ................................................................................................................................... 7-3
8 Preset ........................................................................................................................... 8-1
8.1 Basic Operations .................................................................................................................. 8-2
8.2 System Preset ...................................................................................................................... 8-2
8.2.1 Region ........................................................................................................................... 8-2
8.2.2 General ......................................................................................................................... 8-3
8.2.3 Image Preset ................................................................................................................. 8-3
8.2.4 Meas Param .................................................................................................................. 8-4
8.2.5 OB ................................................................................................................................. 8-5
8.2.6 Key Config .................................................................................................................... 8-5
8.2.7 Option ........................................................................................................................... 8-6
8.3 Exam Preset ......................................................................................................................... 8-6
8.3.1 Exam Selection ............................................................................................................. 8-6
8.3.2 Exam Config ................................................................................................................. 8-7
8.4 Image Preset ........................................................................................................................ 8-7
8.5 Measure Preset .................................................................................................................... 8-9
8.5.1 Measure ........................................................................................................................ 8-9
8.6 Comment Preset ................................................................................................................. 8-10
8.6.1 Comment Library ........................................................................................................ 8-11
8.7 DICOM ................................................................................................................................ 8-15
8.8 Manage Settings ................................................................................................................. 8-16
8.9 Maintenance ....................................................................................................................... 8-17
9 Cleaning and Maintaining the System....................................................................... 9-1
9.1 Daily Maintenance ................................................................................................................ 9-1
9.1.1 Cleaning the System ..................................................................................................... 9-1
9.1.2 Backup of Data ............................................................................................................. 9-2
9.2 Maintenance Checks by Service Engineer .......................................................................... 9-2
9.3 Consumables and Periodic Part Replacement .................................................................... 9-2
9.4 Troubleshooting .................................................................................................................... 9-2
10 Acoustic Output ........................................................................................................ 10-1
10.1 Concerns with Bioeffects .................................................................................................... 10-1
10.2 Prudent Use Statement ...................................................................................................... 10-1
10.3 ALARA Principle (As Low As Reasonably Achievable) ...................................................... 10-1
10.4 Derated Ultrasonic Output Parameters .............................................................................. 10-2
10.5 Measurement Uncertainty .................................................................................................. 10-2
10.6 Parameters Affecting Acoustic Power ................................................................................ 10-2
iv Contents
10.7 Acoustic Power Setting ...................................................................................................... 10-3
10.8 Operations That Change Acoustic Output Power .............................................................. 10-3
10.9 References for Acoustic Power and Safety ........................................................................ 10-4
Appendix A Transducer Maximum Surface Temperature ....................................... A-1
Appendix B Accuracy of Measurement .................................................................... B-1
Appendix C Safety Classification .............................................................................. C-1
Appendix D Guidance and Declaration ..................................................................... D-1
Contents v
© 2009 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2009-05.
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 oth trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.
er
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:
z all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel;
z the electrical installation of the relevant room complies with the applicable national and
local requirements; and
z 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.
Intellectual Property Statement I
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
z Main unit: Integrated facilities which implements the specified function separately.
Generally speaking, the main unit should include power supply, control system and some functional modules.
z Accessories: Materials connected to the main unit to extend or implement specified
function.
z Consumables: 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.
This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
The standard warranty period is as below:
Main unit: 18 months from shipment
Accessories: 15 months from shipment
Main Accessories include transducers, cables, gel bottle and transducer holders
Consumables: N/A
II Warranty
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.
Company Contact
Manufacturer: Shenzhen Mindray Bio-medical Electronics Co., Ltd.
E-mail Address: service@mindray.com.cn
Tel: +86 755 26582479 26582888
Fax:
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Fax: 0049-40-255726
+86 755 26582934 26582500
Tel: 0049-40-2513175
Return Policy III
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:
(1) Damage or loss due to misuse or abuse.
(2) Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc.
(3) Damage or loss caused by failure to meet the specified conditions for this system, such as
inadequate power supply, improper installation or environmental conditions.
(4) Damage or loss due to use of the system outside the region where the system was
originally sold.
(5) Damage or loss involving the system purchased from a source other than Mindray or its
authorized agents.
3. This system shall not be used by persons other than fully qualified and certified medical personnel.
4. Do not make changes or modifications to the software or hardware of this system.
5. In no event shall Mindray be liable for problems, damage, or loss caused by relocation, modification, or repair performed by personnel other than those designated by Mindray.
6. The purpose of this system is to provide physicians with data for clinical diagnosis.
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.
About This Manual
This operator’s manual describes the operating procedures for digital ultrasonic diagnostic imaging system DP-8500/DP-8300. To ensure safe and correct operations, carefully read and understand the manual before operating the system.
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.
CAUTION:
IV Important Information
The digital ultrasonic diagnostic imaging system is not intended for ophthalmic use. Its use in this clinical specialty is contraindicated.
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).
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.
Manuals on Paper
z 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.
z Operator’s Manual [Advanced Volume]: Describes measurement preset, measurements
and calculations, etc.
z Operator’s Manual [Acoustic Power Data and Surface Temperature Data]: Contains data
tables of acoustic output for transducers.
z Operation Note: Contains quick guide for basic operations of the system. z Operator’s Manuals of Transducers: Describe the operation, cleaning, disinfection and
sterilization procedures for transducers.
Software Interfaces in this Manual
Depending on the software version, preset settings and optional configuration, the actual interfaces may be different from those in this manual.
Conventions
In this manual, these conventions are used to describe the buttons on the control panel, the items in menu, buttons in dialog box and some basic operations:
z <Buttons>: The angular bracket indicates buttons on control panel. z [Items in menu and buttons in dialog box]: The square bracket indicates items in menu or
buttons in dialog box.
z Click [Items or Button]: Move the cursor to the item or button and press <Set>. z [Items in Menu]Æ[Items in Submenu]: Selects a submenu item following the path. z [Dyn Rng (Value)]: Indicates menu items with parameter, (value) shows the current value
of the item.
z <Multifunctional Knob (R)> and <Multifunctional Knob (L)>: Indicate the right and left
multifunctional knobs.
Operator’s Manuals V
Safety Precautions
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 words Meaning
DANGER
Indicates an imminently hazardous situation that, if not avoided, will result in death or serious injury.
WARNING
CAUTION
NOTE Indicates a potentially hazardous situation that, if not avoided, may result in
Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury.
property damage.
Meaning of Safety Symbols
Symbols Description
Type-BF applied part
The ultrasound transducers connected to this system are Type-BF applied parts.
"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.
Safety Precautions
Please observe the following precautions to ensure patient’s and operator’s safety when using this system.
DANGER:
WARNING:
VI Meaning of Signal Words
Do not use flammable gasses, such as anesthetic gas or hydrogen, or flammable liquids such as ethanol, near this system, because there is danger of explosion.
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.
WARNING:
2. Use the printing cable provided with this system to connect the printer. Electric shock may result.
3. Before cleaning the system, disconnect the power cord from the outlet. System failure and electric shock may result.
4. 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.
5. 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.
6. Do not allow the patient to contact the live parts of the digital ultrasonic diagnostic imaging system or other devices, e.g. signal I/O ports. Electric shock may occur.
7. 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.
8. Do not subject the transducers to knocks or drops. Use of a defective transducer may cause an electric shock.
9. 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.
10. 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.
11. 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.
12. 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.
Safety Precautions VII
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) Object placed on the monitor may fall and injure an individual.
(2) Fasten and fully secure any peripheral device before moving the
system. A loose peripheral device may fall and injure an individual.
(3) Do not expose the system to excessive vibration through
transportation. Mechanical damage may result.
(4) 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.
4. 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.
5. 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.
6. Do not use the system to examine a fetus for a long period of time.
7. 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.
8. It is necessary to press <Patient> 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.
9. Do not connect or disconnect the system’s power cord or its accessories (e.g., a printer) without turning OFF the power first. This may damage the system and its accessories or cause electric shock.
10. Before using the digital ultrasonic diagnostic imaging system to perform an exam, please carefully read “10 Acoustic Output”.
VIII Safety Precautions
CAUTION:
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. When using or placing the system, keep the system horizontal to avoid disbalance.
4. To avoid damaging the system, do not use it in following environment:
(1) Locations exposed to direct sunlight;
(2) Locations subject to sudden changes in environmental temperature;
(3) Dusty locations;
(4) Locations subject to vibration;
(5) Locations near heat generators;
(6) Locations with high humidity.
5. 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.
6. Do not disconnect a transducer that remains in a live imaging state. This can damage the system and / or transducer. Press [Freeze] key to freeze an image or turn off the power of the system before connecting or disconnecting a transducer.
7. 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.
8. You should properly back up the system to a secure external storage media, including system configuration and settings and patient data. Data stored to the system’s hard drive may be lost due to system failure, improper operation or accident.
9. Do not apply external force to the control panel. The system may be damaged.
10. If the system is used in a small room, the room temperature may rise. Provide proper ventilation and free air exchange.
11. 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.
12. To ensure optimal 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.
13. Do not use gel, disinfectant, transducers or needle-guided brackets that are not compatible with the system.
11. The cover contains natural rubber latex and talc that can cause allergic reactions in some individuals.
12. Please use the ultrasound gel compliant with the relevant local regulations.
13. 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.
Safety Precautions IX
NOTE: 14. The replaceable fuse is inside the chassis. Refer replacing job to Mindray service
engineers or engineers authorized by Mindray only.
15. 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.
16. If the system is powered off improperly during operation, it may result in data damage or system failure.
17. 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.
18. It is recommended to only use the video devices specified in this manual.
19. When copying files to USB storage device, do not pull out the USB storage device forcibly, or damage to USB storage device or this system may occur.
20. Do not connect mobile hard disk with too many partitions.
21. When sending DICOM files or copying files from USB storage devices, do not press the buttons on the control panel.
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.
Latex Alert
WARNING:
When choosing a transducer sheath, 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
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 Latex­containing Medical Devices”, issued on March 29, 1991).
X Latex Alert
Warning Labels
The warning labels are attached to this system in order to call your attention to potential hazards.
The symbol 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
2
on the warning labels indicates safety precautions. The warning labels use the
Cautions against sitting on the system.
a) Cautions that the system must not be used
around flammable gasses.
b) Urges Caution related to handling of the
transducers.
a) b)
For handling of the transducers, refer to the transducers’ operator’s manual.
a) Cautions that the system must be placed
on a horizontal surface.
3
a) b)
b) Cautions that the system must not be
removed covers because the high voltage may cause electric shock.
Warning Labels XI

1 Overview

This chapter introduces the basic information of the system.
1.1
Intended Use: DP-8500/DP-8300 digital ultrasonic diagnostic imaging system are applicable
for ultrasonic exams of human body.
Contraindication: none.
Product and Model Code
DP-
NOTE: The functions described in the operator’s manual may vary depending upon the specific
1.2
1.2.1
Power Supply
Voltage:

General

Model Code Product Code
system you purchased.

Product Specifications

Environmental Conditions

100-240V~, fluctuation of ±10% is allowed
Frequency: 50/60Hz
Input current: 3.5-1.5A
Environment conditions
Operating Storage and transportation
Ambient temperature:
Relative humidity: 30%~90%RH (no condensation) 30%~95%RH (no condensation)
Atmospheric pressure:
WARNING:
0℃~40℃ -20℃~55℃
700hPa～1060hPa
Do not use this system in the conditions other than those specified.
700hPa~1060hPa

1.2.2 Dimensions and Weight

z External dimensions: 1225mm×705mm×500mm (H×L×W) z Net weight: 41.7kg
Overview 1-1
1.3

System Configuration

1.3.1
Main unit
Accessories
z Power cord of the main unit z Chassis earth lead z Power cord of video printer z Remote cable of printer z Dirt guard z Gel z Operator’s manual
1.3.2
Model Typ e Intended Use
35C20EA Convex
35C50EA (applicable for DP-8500 only)

Standard Configuration

Transducers Available

Gynecology, abdomen, pediatrics, musculoskeletal (general), peripheral vascular, cardiac and nerve
Gynecology, obstetrics, abdomen, pediatrics,
Convex
musculoskeletal (general), peripheral vascular, urology and nerve
Region
Applied
Body surface
Body surface
35C50EB (applicable for DP-8300 only)
65C15EA Convex
65EC10EA
65EL60EA
75L38EA
75L53EA
75L60EA
75LT38EA Linear
Convex
Endocavity convex
Endocavity linear
Linear
Gynecology, obstetrics, abdomen, pediatrics, musculoskeletal (general), peripheral vascular, urology and nerve
Abdomen, pediatrics, neonatal cephalic, adult cephalic, musculoskeletal (general), pediatric cardiac, peripheral vascular and nerve
Gynecology, obstetrics, urology and neonatal cephalic
Urology (prostate and seminal vesicle) and rectum
Abdomen, pediatrics, small organs (such as mammary gland, thyroid and testis), neonatal cephalic, musculoskeletal (general and superficial), peripheral vascular, orthopedics and nerve
Abdomen, pediatrics, small organs (such as mammary gland, thyroid and testis), neonatal cephalic, musculoskeletal (general and superficial), peripheral vascular, orthopedics, nerve and intraoperative
Body surface
Body surface
Transvaginal, transrectal
Transrectal
Body surface
Body surface, intraoperative
1-2 Overview

1.3.3 Optional Parts

No. Name Model or Description
1 DICOM software DICOM3.0
2 Foot switch 971-SWNOM
3 14” CRT /
4 Hard disk /
5 Optical disc drive /
6 LCD /

1.3.4 Peripherals Supported

No. Name Model
HP Photosmart D5368
HP Business Inkjet 1200
1 Graph/text printer (USB port)
HP DeskJet 1280
HP DeskJet 3820
HP DeskJet 5650
HP DeskJet 6548
MITSUBISHI P93W
2 Video printer
WARNING:
NOTE: For any question about choice and use of the printers, contact Mindray customer
service department.
This system complies with IEC60601-1-2: 2001+A1: 2004, and its RF emission meets the requirements of CISPR11 Class B. In a domestic environment, the customer or the user should guarantee to connect the system with Class B peripheral devices; otherwise RF interference may result and the customer or the user must take adequate measures accordingly.
MITSUBISHI P93W-Z
SONY UP-895MD
SONY UP-897MD

1.4 System Introduction

This section introduces the structure of the system, taking the system with CRT as example.
NOTE: The illustrations in the manual are for reference only. What appears in the illustrations
may vary depending upon the specific system you purchased.
Overview 1-3

1.4.1 Introduction of Each Unit

1
4
10
8
Front view
2
3
<9>
9
<5>
5
<6>
6
<7>
7
12
15
11
14
13
Left side view
1-4 Overview
No. Name Function and Connection
1 Monitor Displays images and parameters, etc.
2 Hook for transducer cable Used for hanging the transducer cable.
Transducer and gel bottle
3
holder
4 Printer area Used for mounting a printer.
5 Video output Connects to the video input port of the video printer.
6 AC out Connects to the power cord of the video printer.
7 Remote Connects to the remote control port of the video printer.
8 Transducer socket Used for connecting a transducer.
9 Footswitch port Connects a footswitch.
10 Casters Used for locking or moving the system.
11 Control panel Refer to “1.4.3 Control Panel” for details.
12 Handle Used for moving the system.
Used for holding the transducer or gel bottle provisionally.
Used for connecting a USB device.
For systems with optical disc drive, the USB ports locate
13 USB port
under the power switch, of which the lower one is reserved.
For systems without optical disc drive, the USB ports locate to the left of the power switch.
14 Power switch Power on / off
15 Optical disc drive (optional) Backs up/restores data

1.4.2 I/O Panel

The I/O panel locates at the back of the system.
1
No. Name Function
1 Network port Accepts the network cable.
2 Video out (S-video) Connects to the video input port of the video printer.
3 Video out (coaxial connector) Connects to the video input port of the video printer.
2 3 4
4 VGA out Connects an external monitor.
Overview 1-5

1.4.3 Control Panel

<1> <2>
<8>
<3>
<4>
<5> <6> <7>
<9>
TGC
()()
()()
()()
()()
()()
()()
()()
<16>
<10>
<12>
<11>
IPF.p o si t io n
Depth
Zoom
Rotation
<13>
<1
>
5
1
<
>
4
<20>
>
9
1
<
<22>
<
1
7
>
<
1
8
>
<
2
1
>
<24>
<26> <27> <28>
Gain
<29>
No. Name Function
1 Patient Ends the current exam.
2 Info Opens/closes the patient information dialog box.
3 File Opens iStation.
4 Exam Opens the exam mode menu to select an exam mode.
()()
<25><23>
<30>
5 Blank key Reserved.
6 Probe Switches transducers.
7 Freq. Switches the transmitting frequency.
8
Character & number keys
Used for inputting characters and symbols.
9 TGC Time Gain Compensation
10 F.position Adjusts location of the focus.
11 IP
Adjusts the image quality according to a set of preset image parameters.
1-6 Overview
No. Name Function
Press to switch among items and rotate to adjust the corresponding item:
12 Depth/Zoom /Rotation
z Depth: Adjusts the depth. z Zoom: Magnifies the image. z Rotation: Rotates the arrow mark or the transducer
mark of the body mark.
13 Print Printing
14 Cine
15 Measure Enters/exits measure mode.
16 BodyMark Adds body mark to the image.
17 Comment Enters/exits character comment mode.
18 Menu Opens/closes the menu of the current mode.
19 Set Selects items/Confirms an operation/Increases a parameter.
Switches between auto/manual cine review modes. Releases the cursor.
Switches among items before beginning a measurement.
20 Change
21 Back Cancels the last step/Decreases a parameter.
22 Trackball Moves the cursor.
23 B Switches to B mode.
24
25 VRev Flips the image vertically.
26
27 M Switches to M mode
B＋B
M＋B
Switches between cursors during a measurement.
Switches to dual B mode or switches between windows in dual B mode.
Switches to M+B mode.
28 HRev Flips the image horizontally.
29 Freeze Freezes/unfreezes the image.
30 Gain Adjusts the gain of image when rotated.
Overview 1-7

1.4.4 Symbols

This system uses the symbols listed in the following table, and their meanings are explained as well.
Symbol Description Location
│ Main switch ON
Dangerous voltage Inside the machine
Main switch OFF
Serial number
AC (Alternating current)
Date of manufacture
Manufacturer
This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93 / 42 / EEC concerning Medical Devices. The number adjacent to the CE marking (0123) is the number of the EU-notified body certified for meeting the requirements of the Directive.
Video printing control
Video out
Power switch
Label of the machine
A
B
VGA out
I/O panel
Foot switch
USB port
Network port
Transducer socket A
Transducer sockets
Transducer socket B
1-8 Overview

2 Preparing the System

This chapter introduces how to prepare and get familiar with the system.
2.1
2.1.1
Please read and understand the safety precautions before moving and placing the system.
1. Turn off the power and disconnect the peripheral devices.
2. Unlock the four casters.
3. Move the system to the desired position using the handle.
4. Leave at least 20cm clearance at the back and two sides of the machine.
5. Lock the four casters.
CAUTION:

Setup and Connections

Moving and Placing the System

Ensure enough clearance at the back and both side of the machine, otherwise failure may happen because of the increasing temperature inside the machine.

2.1.2 Connecting the Power Cord

Connecting the power cord
WARNING:
1. Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as life­support 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.
2. Do not connect the three-wire power cable of the machine to a two­wire plug without grounding protection phase, otherwise electric shock may happen.
1. Ensure that the external power supply system meets the requirements and the power switch of the system is turned off.
2. Attach the connector of the power cord to the system.
3. Insert the power plug securely into the wall outlet.
Connecting the chassis earth lead
The chassis earth lead is used to put the ultrasonic system to earth and make the ultrasonic system equipotential with the other devices connected to the system.
1. Connect the connector of the chassis earth lead to the equipotential terminal of the
ultrasonic system.
2. Put the clip of the chassis earth lead to earth.
Preparing the System 2-1
3. Put the equipotential terminals of the other devices connected to the ultrasonic system to earth.
WARNING:
1. When you connect another device to this system, you should use the equipotential wire to connect each of equipotential terminals; otherwise electric shock may result.
2. Be sure to connect the equipotential wire before inserting the power plug into the receptacle; be sure to remove the power plug from the receptacle before disconnecting the equipotential wire; otherwise electric shock may result.

2.1.3 Connecting/Disconnecting the Transducers

CAUTION:
NOTE: Use the transducer provided by Mindray only. Otherwise may damage the system and
transducer or cause a fire.
1. Connect/disconnect the transducer only after the system power is turned off or the image is frozen (by Freeze key), otherwise failure may happen.
2. When connecting/disconnecting the transducer, place the transducer on the corresponding transducer holder and hook the transducer cable on the cable hanger to avoid accidental falling of the transducer, which may damage the transducer.
Connecting the transducer
WARNING:
1. Turn off the ultrasonic system or freeze the image.
2. Check whether the lock of the transducer connector is released. If not, turn the lock counter-clockwise to release it.
3. Keep the cable upwards and insert the transducer connector straight into the socket.
4. Turn the lock clockwise to lock the transducer connector.
5. Hang the transducer cable to the hanger.
Prior to connecting the transducer, the user should ensure that the transducer, cable and the connector are all in good condition (no rift or fall-off). Electric shock may happen if using any abnormal transducer.
3
4
2-2 Preparing the System
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