DP-6900 Operators Manual V 8.0

Contents Intellectual Property Statement ... I Responsibility on the Manufacturer Party ... I Warranty ... II Exemptions... II Customer Service Department ... III Important Information ... III About This Manual ... IV Notation Conventions ... IV Operator’s Manuals ... IV Manuals on Paper ... IV Software Interfaces in this Manual ... IV Conventions ... V

Safety Precautions ... VI Meaning of Signal Words ... VI Meaning of Safety Symbols... VI Safety Precautions ... VI Latex Alert ... XII Warning Labels... XIII

1

Overview ... 1-1 1.1

General ... 1-1

1.2

Product Specifications ... 1-1

1.3

1.4

2

1.2.1

Environmental Conditions ... 1-1

1.2.2

Dimensions and Weight ... 1-1

System Configuration ... 1-2 1.3.1

Standard Configuration ... 1-2

1.3.2

Transducers Available ... 1-2

1.3.3

Optional Parts ... 1-3

1.3.4

Peripherals Supported ... 1-3

System Introduction... 1-4 1.4.1

Introduction of Each Unit ... 1-4

1.4.2

I/O Panel ... 1-6

1.4.3

Control Panel ... 1-7

1.4.4

Symbols ... 1-9

Preparing the System ... 2-1 2.1

Setup and Connections ... 2-1 2.1.1

Moving and Placing the System ... 2-1

Contents i

2.2

3

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

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 ... 2-5

2.3

Main Interface ... 2-6

2.4

Basic Operations ... 2-7

Beginning an Exam ... 3-1 3.1

Entering Patient Information ... 3-1

3.2

Getting 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

3.6

3.7

4

2.1.2

3.5.1

Zooming ... 3-4

3.5.2

Zooming with Thumbnail ... 3-4

3.5.3

Rotating and Flipping the Image ... 3-4

3.5.4

Image Merge ... 3-5

Cine Review ... 3-5 3.6.1

Cine Review of B Mode ... 3-5

3.6.2

Cine Review of 2B/4B Mode ... 3-6

3.6.3

Cine Review of M/M+B Mode ... 3-6

Brief Introductions to Measurement ... 3-6 3.7.1

Basic Operations and Buttons ... 3-7

3.7.2

Measurement Items ... 3-8

Optimizing the Image ... 4-1 4.1

Basic Operations ... 4-1

4.2

B Mode ... 4-2 4.2.1

Depth ... 4-2

4.2.2

Frequency ... 4-2

4.2.3

Gain ... 4-3

4.2.4

Acoustic Power ... 4-3

ii Contents

4.2.5

TGC ... 4-4

4.2.6

Focus ... 4-4

4.2.7

B/M Dyn Rng (Dynamic Range) ... 4-5

4.2.8

Img Enhance (Image Enhance) ... 4-5

4.2.9

Frame Avg (Frame Average) ... 4-5

4.2.10 TSI ... 4-6 4.2.11 Scan Mode... 4-6 4.2.12 IP... 4-7 4.2.13 B/M Post Process ... 4-7 4.3

5

5.2

6.2

8

M Speed... 4-9

4.3.2

Edge Enhance ... 4-9

4.3.3

M Soften ... 4-10

Comments ... 5-1 5.1.1

Adding Comments ... 5-1

5.1.2

Adding Arrow ... 5-2

5.1.3

Moving Comments/Arrows... 5-2

5.1.4

Editing Comments ... 5-2

5.1.5

Deleting Comments/Arrows ... 5-2

Body Mark ... 5-3 5.2.1

Adding Body Mark ... 5-3

5.2.2

Moving the Body Mark ... 5-3

5.2.3

Editing the Body Mark ... 5-3

5.2.4

Deleting the Body Mark ... 5-3

Auxiliary Functions ... 6-1 6.1

7

4.3.1

Annotating the Image ... 5-1 5.1

6

M Mode ... 4-9

Biopsy Guide ... 6-1 6.1.1

Basic Operations ... 6-1

6.1.2

Adjusting the Guide Line ... 6-1

Lithotrity ... 6-2

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

iVision ... 7-3

Probes and Biopsy ... 8-1 8.1

Probes ... 8-1 8.1.1

Name and Function of Each Part of the Probe... 8-3

Contents iii

8.2

9

8.1.2

Orientation of the Ultrasound Image and the Probe Head ... 8-5

8.1.3

Procedures for Operating ... 8-6

8.1.4

Wearing the Probe Sheath ... 8-9

8.1.5

When the Immersion Method is Used (65EL60EA) ... 8-10

8.1.6

Probes Cleaning and Disinfection... 8-14

8.1.7

Storage and Transportation ... 8-17

Biopsy Guide ... 8-19 8.2.1

Needle-guided Brackets... 8-21

8.2.2

Basic Procedures for Biopsy Guiding ... 8-28

8.2.3

Needle-guided Bracket Inspection and Installation ... 8-29

8.2.4

Verifying the Biopsy Guide Line ... 8-34

8.2.5

Removing the Needle-guided Bracket ... 8-35

8.2.6

Clean and Sterilize the Needle-guided Bracket ... 8-38

8.2.7

Storage and Transportation ... 8-39

8.2.8

Disposal ... 8-39

Preset ... 9-1 9.1

Basic Operations ... 9-2

9.2

System Preset ... 9-2

9.3

9.2.1

Region ... 9-2

9.2.2

General ... 9-3

9.2.3

Image Preset... 9-3

9.2.4

Meas Param... 9-4

9.2.5

OB ... 9-5

9.2.6

Key Config ... 9-5

9.2.7

Option ... 9-6

Exam Preset ... 9-6 9.3.1

Exam Selection ... 9-6

9.3.2

Exam Config ... 9-7

9.4

Image Preset ... 9-7

9.5

Measure Preset ... 9-9 9.5.1

9.6

Measure ... 9-9

Comment Preset... 9-10 9.6.1

Comment Library ... 9-11

9.7

DICOM ... 9-15

9.8

Manage Settings... 9-16

9.9

Maintenance ... 9-16

10 Network Print ... 10-1 10.1 Application Software on PC End ... 10-1 10.2 Network Print ... 10-1

iv Contents

11 Cleaning and Maintaining the System ...11-1 11.1 Daily Maintenance ... 11-1 11.1.1 Cleaning the System ... 11-1 11.1.2 Backup of Data ... 11-2 11.2 Maintenance Checks by Service Engineer ... 11-2 11.3 Consumables and Periodic Part Replacement ... 11-2 11.4 Troubleshooting ... 11-2

12 Acoustic Output ... 12-1 12.1 Concerns with Bioeffects ... 12-1 12.2 Prudent Use Statement ... 12-1 12.3 ALARA Principle (As Low As Reasonably Achievable) ... 12-1 12.4 Measurement Uncertainty ... 12-2 12.5 Limits of Acoustic Output ... 12-2 12.6 Parameters Affecting Acoustic Power ... 12-2 12.7 Acoustic Power Setting ... 12-2 12.8 Operations That Change Acoustic Output Power ... 12-3 12.9 References for Acoustic Power and Safety ... 12-3

Appendix A

Accuracy of Measurement ... A-1

Appendix B

Safety Classification ... B-1

Appendix C

Guidance and Manufacturer's Declaration ... C-1

Appendix D

Electrical Safety Inspection ... D-1

Contents v

© 2009-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is 2014-02.

Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. ，

,

,

,

,

BeneView, WATO,

BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: z z z

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; and the product is used in accordance with the instructions for use.

Note This equipment must be operated by skilled/trained clinical professionals. Warning It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

Safety Precautions 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.

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.

II Safety Precautions

Customer Service Department Manufacturer:

Shenzhen Mindray Bio-medical Electronics Co., Ltd.

Address: Mindray Building,Keji 12th Road South,High-tech industrial park,Nanshan,Shenzhen 518057,P.R.China Website: www.mindray.com E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430-0619 USA Tel: +1(201) 995-8000 Toll Free: +1 (800) 288-2121 Fax: +1 (800) 926-4275

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. It is the physician’s responsibility for diagnostic procedures. Mindray shall not be liable for the results of diagnostic procedures. 7. Important data must be backed up on external memory media. 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, 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.

Safety Precautions III

10. 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-6900. 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:

1. United States federal law restricts this device to be sale by or on the order of a physician. 2. The digital ultrasonic diagnostic imaging system is not intended for ophthalmic use. Its use in this clinical specialty is contraindicated.

Operator’s Manuals You may receive multi-language manuals in compact disc or paper. Please refer to English manual for latest information and register information. 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

z z 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. Operator’s Manual [Advanced Volume]: Describes measurement preset, measurements and calculations, etc. Operator’s Manual [Acoustic Power Data and Surface Temperature Data]: Contains data tables of acoustic output for transducers. Operation Note: Contains quick guide for basic operations of the system.

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.

IV Safety Precautions

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 z z z z z

<Buttons>: The angular bracket indicates buttons on control panel. [Items in menu and buttons in dialog box]: The square bracket indicates items in menu or buttons in dialog box. Click [Items or Button]: Move the cursor to the item or button and press <Set>. [Items in Menu]Æ[Items in Submenu]: Selects a submenu item following the path. [Dyn Rng (Value)]: Indicates menu items with parameter, (value) shows the current value of the item. <Multifunctional Knob (R)> and <Multifunctional Knob (L)>: Indicate the right and left multifunctional knobs.

Safety Precautions 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

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

CAUTION

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

NOTE

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:

Do not use flammable gasses, such as anesthetic gas or hydrogen, or flammable liquids such as ethanol, near this system and probes, because there is danger of explosion.

WARNING:

1. Connect the adapter power plug of this system and power plugs of the peripherals to wall receptacles that meet the ratings indicated on the rating nameplate. Using a multifunctional receptacle may affect the system grounding performance, and cause the leakage current to exceed safety requirements. You must use the power adapter provided with the system; otherwise electric shock may result.

VI Safety Precautions

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. 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. 12. 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. 13. 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. 14. When using intra-cavity transducers, do not activate the transducer outside the patient’s body.

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) When you place the system on the mobile trolley and move them together, you must secure all objects on the mobile trolley to prevent them from falling. Otherwise you should separate the system from the mobile trolley and move them individually. (2) When you have to move the system with the mobile trolley upward or downward the stairs, you must separate them first and then move them individually. (3) Object placed on the monitor may fall and injure an individual. (4) Fasten and fully secure any peripheral device before moving the system. A loose peripheral device may fall and injure an individual. (5) Do not expose the system to excessive vibration through transportation. Mechanical damage may result. (6) Always keep the system dry. Avoid transporting this system quickly from a cold place to a warm place; otherwise condensation or water droplets may form allowing a short circuit and possible electric shock. 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.

VIII Safety Precautions

8. It is necessary to press <End Exam> to end the current scan that is in progress and clear the current Patient Information field. Otherwise new patient data may be combined with the previous patient data. 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”. 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.

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.

Safety Precautions IX

NOTE:

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. 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 using this system with portable package, be careful not to block the ventilation slots. 20. 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. 21. Do not connect mobile hard disk with too many partitions. 22. When sending DICOM files or copying files from USB storage devices, do not press the buttons on the control panel.

Please read the following precautions carefully to ensure the safety of the patient and the operator when using the probes.

WARNING:

X Safety Precautions

1.

This ultrasonic probe is only for use with the specified ultrasonic diagnostic system. Please refer to “1.3.2 Transducers Available” to select the proper probe.

2.

Confirm that the probe and cable are normal before and after each examination. A defective probe may cause electric shock to the patient.

3.

Do not subject the probe to shock. A defective probe may cause electric shock to the patient.

4.

Do not disassemble the probe to avoid the possibility of electric shock.

5.

Never immerse the probe connector into liquids such as water or disinfectant because the connector is not waterproof. Immersion may cause electric shock or malfunction.

6.

Ultrasonic probe is only for use with the specified ultrasonic diagnostic system. Please refer the ultrasonic diagnostic system operation manual to select the proper probe.

7.

A probe sheath must be installed over the probe before performing intra-cavity or intra-operative examination.

CAUTION: 1. When using the probe, wear sterile gloves to prevent infection. 2. Be sure to use ultrasound gel. Please use the ultrasound gel compliant with the relevant local regulations. 3. In normal diagnostic ultrasound mode, there is no danger of a normaltemperature burn; however, keeping the probe on the same region of the patient for a long time may cause such a burn. 4. Do not use the carrying case for storing the probe. If the carrying case is used for storage, it may become a source of infection. 5. The probe and accessories supplied with it are not delivered disinfected or sterilized. Sterilization (or high-level disinfect) before use is required. 6. It is required to practice ALARA when operating ultrasound system. Minimize the acoustic power without compromising the quality of images. 7. Disposable components are packaged sterile and are single-use only. Do not use if integrity of packaging violated or if expiration date has passed. Please use the disposable components compliant with the relevant local regulations. 8. Please use the disinfection or sterilization solution that recommended in this operator’s manual, otherwise Mindray will not be liable for damage caused by other solutions. If you have any questions, please contact Mindray Customer Service Department or sales representative. 9. Do not use pre-lubricated condoms as a sheath. Lubricant may not be compatible with the transducer material and damage may result. 10. Transducer damage may be caused by inappropriate gel, detergent or cleanser: Do not soak or saturate transducers with solutions containing alcohol, bleach, ammonium chloride compounds, acetone or formaldehyde. Avoid contact with solutions or coupling gels containing mineral oil or lanolin.

NOTE:

1. Read the following precautions to prevent the probe from malfunction. z Before connecting or disconnecting the probe, freeze or turn off the ultrasound diagnostic system. z Clean and disinfect the probe before and after each examination. z After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the ultrasound gel may solidify and the image quality would be degraded. 2. Ambient conditions: To prevent the probe from being damaged, do not use it where it will be exposed to: z direct sunlight or X-rays z sudden changes in temperature z dust z excessive vibration z heat generators Use the probes under the specified ambient conditions. 3. Repeated disinfection will eventually damage the probe, please check the probe’s performance periodically.

Safety Precautions XI

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 Latexcontaining Medical Devices”, issued on March 29, 1991).

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

XII Safety Precautions

Warning Labels The warning labels are attached to this system in order to call your attention to potential hazards. The symbol on the warning labels indicates safety precautions. The warning labels use the same signal words as those used in the operator’s manual. Refer to the operator’s manual for detailed information about the warning labels. Read operator’s manual carefully before using the system. The name, pattern and meaning of each warning label are described as follows: No.

Label

Meaning

1

Caution! Please carefully read this manual before use system.

2

Prohibit using system with flammable anesthetics, or explosion risk may happen

The following labels are available when the system works with the mobile trolley. 3

a. Do not place the system on a sloped surface. Otherwise the system may slide, resulting in personal injury or the system malfunction. Two persons are required to move the system over a sloped surface. b. Do not sit on the system. c. DO NOT push the system when the casters are locked.

4

Medical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL60601-1, CAN/CSA-C22.2 NO.601.1-M90, IEC60601-1-1 and IEC60601-237.

Safety Precautions XIII

1

Overview

This chapter introduces the basic information of the system.

1.1

General

„

Intended Use: DP-6900 digital ultrasonic diagnostic imaging system is applicable for ultrasonic exams of human body.

„

Contraindication: none.

„

Product and Model Code DPModel Code Product Code

NOTE:

The functions described in the operator’s manual may vary depending upon the specific system you purchased.

1.2

Product Specifications

1.2.1

Environmental Conditions

„

Power Supply

Voltage:

100-240V~, fluctuation of ±10% is allowed

Frequency:

50/60Hz

Input current:

1.5-0.7A

„

Environment conditions Operating

Storage and transportation

Ambient temperature:

5℃~40℃

-20℃~55℃

Relative humidity:

35%~85%RH (no condensation)

30%~85%RH (no condensation)

Atmospheric pressure:

700hPa～1060hPa

700hPa~1060hPa

WARNING:

1.2.2 z z

Do not use this system in the conditions other than those specified.

Dimensions and Weight External dimensions: 330mm×410mm×265mm (H×L×W) Net weight: 10.3kg

Overview 1-1