Z6 Diagnostic Ultrasound System Operators Manual March 2019

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

1

Safety Precautions... 1-1 1.1 1.2 1.3 1.4 1.5 1.6

2

Safety Classification ... 1-1 Meaning of Signal Words... 1-1 Meaning of Safety Symbols ... 1-2 Safety Precautions ... 1-2 Latex Alert ... 1-9 Warning Labels ... 1-10

System Overview ... 2-1 2.1 2.2 2.3 2.4

Intended Use ... 2-1 Contraindication ... 2-1 Product and Model Code ... 2-1 Product Specifications ... 2-1 2.4.1 Imaging Mode ... 2-1 2.4.2 Power supply ... 2-2 2.4.3 Environmental Conditions... 2-2 2.4.4 Size and weights ... 2-2 2.5 System Configuration ... 2-2 2.5.1 Standard Configuration... 2-2 2.5.2 Probes Available ... 2-3 2.5.3 Options ... 2-5 2.5.4 Peripherals Supported ... 2-6 2.6 Introduction of Each Unit ... 2-7 2.6.1 I/O Panel... 2-9 2.6.2 Power Supply Panel ... 2-9 2.6.3 Control Panel ... 2-10 2.7 Symbols ... 2-13

3

System Preparation ... 3-1 3.1 3.2

Move/Position the System ... 3-1 Power Supply ... 3-1 3.2.1 Connecting External Power Supply ... 3-1 3.2.2 Powered by Battery ... 3-2 3.3 Powering ON/ OFF ... 3-2 3.3.1 Powering ON ... 3-2 3.3.2 Powering OFF... 3-3 3.4 Connecting / Disconnecting a Probe ... 3-4

i

3.4.1 Connecting a Probe ... 3-4 3.4.2 Disconnecting a Probe ... 3-5 3.5 Connecting the Footswitch... 3-5 3.6 Connecting/ Removing a USB Storage Device... 3-5 3.7 Graph / Text Printer ... 3-6 3.7.1 Connecting a Local Printer ... 3-6 3.7.2 Add Network Printer ... 3-8 3.7.3 Add Shared Printer... 3-8 3.7.4 iStorage UltraAssist Print... 3-9 3.7.5 Print Service ... 3-9 3.8 Digital Video Printer ... 3-9 3.9 Analog Video Printer... 3-10 3.10 External DVD ... 3-10 3.11 Basic Screen and Operation ... 3-11 3.11.1 Basic Screen... 3-11 3.11.2 Basic Operations of Screens ... 3-13

4

Exam Preparation ... 4-1 4.1 4.2

Start an Exam... 4-1 Patient Information ... 4-1 4.2.1 New Patient Information ... 4-2 4.2.2 Retrieve Patient Information ... 4-5 4.3 Select Exam Mode and Probe ... 4-7 4.3.1 Selecting Exam Mode and Probe ... 4-7 4.4 Selecting Imaging Mode ... 4-8 4.5 Activate& Continue an Exam ... 4-8 4.5.1 Activate an Exam ... 4-8 4.5.2 Continue an Exam ... 4-8 4.6 Pause & End an Exam ... 4-9 4.6.1 Pause and Exam ... 4-9 4.6.2 End an Exam ... 4-9

5

Image Optimization ... 5-1 5.1 5.2 5.3

Imaging Mode ... 5-1 Basic Operations ... 5-1 B Mode ... 5-2 5.3.1 B Mode Exam Protocol... 5-2 5.3.2 B Mode Parameters ... 5-2 5.3.3 B Mode Image Optimization ... 5-2 5.4 M Mode ... 5-7 5.4.1 M Mode Exam Protocol ... 5-7 5.4.2 M Mode Parameters... 5-8 5.4.3 M Mode Image Optimization... 5-8 5.5 Color Mode Image Optimization... 5-10 5.5.1 Color Mode Exam Protocol... 5-10 5.5.2 Color Mode Image Optimization ... 5-10 5.5.3 Color Mode Image Optimization ... 5-10 5.6 Power Mode Image Optimization ... 5-14 5.6.1 Basic Procedures for Power Mode Imaging ... 5-14 5.6.2 Power Mode Image Parameters ... 5-14 5.6.3 Power Mode Image Optimization... 5-14 5.7 PW/CW Doppler Mode ... 5-15

ii

5.7.1 Basic Procedures for PW / CW Mode Exam ... 5-15 5.7.2 PW/CW Mode Image Parameters... 5-16 5.7.3 PW/CW Mode Image Optimization ... 5-16 5.8 Color M Mode... 5-21 5.8.1 Enter Color M Mode ... 5-21 5.8.2 Exit Color M Mode ... 5-21 5.8.3 Color M Mode Image Parameters ... 5-21 5.9 Anatomical M Mode (Free Xros M) ... 5-22 5.10 TDI ... 5-23 5.10.1 Basic Procedures for TDI Imaging ... 5-23 5.10.2 TDI Image Parameters ... 5-24 5.10.3 TDI Image Optimization... 5-24 5.11 iScape ... 5-24 5.11.1 Basic Procedures for iScape Imaging ... 5-25 5.11.2 Image Acquisition ... 5-25 5.11.3 iScape Viewing ... 5-26 5.11.4 Cine Review... 5-27 5.12 3D/4D... 5-28 5.12.1 Note before Use ... 5-28 5.12.2 Overview... 5-29 5.12.3 Static 3D ... 5-32 5.12.4 Smart 3D ... 5-40 5.12.5 4D... 5-43 5.12.6 iLive ... 5-44 5.12.7 iPage ... 5-44 5.13 Elastography ... 5-47 5.13.1 Basic Procedure for Elastography ... 5-47 5.13.2 Enter/Exit ... 5-47 5.13.3 Pressure Hint Curve ... 5-48 5.13.4 Mass Measurement... 5-49 5.13.5 Cine Review... 5-49 5.14 Contrast Imaging ... 5-49 5.14.1 Basic Procedures for Contrast Imaging ... 5-49 5.14.2 Measurement, Comment and Body Mark... 5-52

6

Display & Cine Review ... 6-1 6.1

Image Display ... 6-1 6.1.1 Splitting Display... 6-1 6.1.2 Image Magnification ... 6-1 6.1.3 Freeze/ Unfreeze the Image ... 6-2 6.2 Cine Review ... 6-3 6.2.1 Entering/ Exiting Cine Review ... 6-3 6.2.2 Cine Review in 2D Mode ... 6-4 6.2.3 Cine Review in M/ PW/ CW/ TVD Mode ... 6-5 6.2.4 Linked Cine Review ... 6-5 6.3 Image Compare... 6-6 6.3.1 Image Compare in Review Mode... 6-6 6.3.2 Frame Compare ... 6-6 6.4 Cine Memory... 6-6 6.4.1 Cine Memory Setting... 6-6 6.4.2 Cine Memory Clear ... 6-7 6.5 Preset ... 6-7

iii

7

ECG... 7-1 7.1 7.2 7.3

8

ECG Operation Basic Procedures ... 7-2 Parameter Description ... 7-3 ECG Review... 7-3

Measurement... 8-1 8.1 8.2

Basic Operations ... 8-1 General Measurements ... 8-1 8.2.1 2D General Measurements ... 8-1 8.2.2 M General Measurements ... 8-2 8.2.3 Doppler General Measurements ... 8-3 8.3 Application Measurement ... 8-3 8.4 Measurement Accuracy ... 8-4

9

Comments and Body Marks ... 9-1 9.1

Comments... 9-1 9.1.1 Comment Basic Procedures ... 9-1 9.1.2 Comment Menu ... 9-1 9.1.3 Adding Comments... 9-2 9.1.4 Moving Comments ... 9-3 9.1.5 Editing Comments ... 9-3 9.1.6 Deleting Comments... 9-3 9.2 Body Mark ... 9-4 9.2.1 Body Mark Operation Procedures... 9-4 9.2.2 Menu ... 9-4 9.2.3 Adding Body Marks ... 9-4 9.2.4 Moving Body Marks... 9-5 9.2.5 Deleting Body Marks ... 9-5

10 Patient Data Management... 10-1 10.1 Patient Information Management ... 10-1 10.1.1 Enter Patient Information... 10-1 10.2 Image File Management ... 10-1 10.2.1 Storage Media... 10-1 10.2.2 Image File Formats ... 10-1 10.2.3 Image Storage Preset ... 10-2 10.2.4 Saving Images to the System ... 10-2 10.2.5 Quickly Saving Images to USB Flash Drive ... 10-3 10.2.6 Quickly Saving Full Screen Image to the System ... 10-3 10.2.7 Thumbnails ... 10-3 10.2.8 Image Review and Analysis... 10-4 10.2.9 iVision ... 10-6 10.2.10 Sending Image File ... 10-7 10.3 Report Management ... 10-7 10.4 Patient Data Management (iStation) ... 10-9 10.4.1 Searching a Patient ... 10-10 10.4.2 Patient Data View & Management ... 10-10 10.5 Backing Up and Erasing Files through DVD Drive... 10-12 10.6 Patient Task Manager ... 10-13 10.7 Access Control ... 10-14 10.7.1 Access Setting ... 10-14 10.7.2 Setting Access Control ... 10-14 10.7.3 System Login ... 10-14

iv

10.7.4 Adding/ Deleting a User ... 10-15 10.7.5 Modifying Password ... 10-17

11 DICOM... 11-1 11.1 DICOM Preset ... 11-2 11.1.1 Network Preset ... 11-2 11.1.2 DICOM Preset ... 11-3 11.1.3 DICOM Service ... 11-4 11.2 Verify Connectivity ... 11-9 11.3 DICOM Service ... 11-9 11.3.1 DICOM Storage... 11-9 11.3.2 DICOM Print ... 11-11 11.3.3 DICOM Worklist ... 11-12 11.3.4 MPPS ... 11-13 11.3.5 Storage Commitment ... 11-13 11.3.6 Query/Retrieve... 11-14 11.4 DICOM Media Storage ... 11-16 11.5 Structured Report ... 11-17 11.6 DICOM Task Manager ... 11-17

12 Setup... 12-1 12.1 System Preset ... 12-1 12.1.1 Region ... 12-2 12.1.2 General ... 12-3 12.1.3 Image Preset ... 12-4 12.1.4 Application ... 12-5 12.1.5 OB ... 12-5 12.1.6 Key Config ... 12-5 12.1.7 Admin ... 12-6 12.2 Exam Preset... 12-6 12.3 Measure Preset ... 12-7 12.4 Print Preset ... 12-7 12.5 Network Preset ... 12-8 12.5.1 MedSight Preset ... 12-9 12.6 Maintenance ... 12-9 12.6.1 Option ... 12-9 12.6.2 Other Settings ... 12-10 12.7 System Information ... 12-10

13 Probes and Biopsy ... 13-1 13.1 Probe ... 13-1 13.1.1 Name and Function of Each Part of the Transducer ... 13-4 13.1.2 Orientation of the Ultrasound Image and the Transducer Head ... 13-5 13.1.3 Operating Procedures ... 13-6 13.1.4 Wearing the Transducer Sheath ... 13-8 13.1.5 Probes Cleaning and Disinfection... 13-9 13.1.6 Storage and Transportation ... 13-13 13.2 Biopsy Guide ... 13-13 13.2.1 Basic Procedures for Biopsy Guiding... 13-16 13.2.2 Needle-guided Brackets ... 13-16 13.2.3 Needle-guided Bracket Inspection and Installation... 13-24 13.2.4 Biopsy Menu ... 13-31 13.2.5 Verify Biopsy Guide Line ... 13-32

v

13.2.6 iNeedle (Needle Visualization Enhancement ) ... 13-33 13.2.7 Removing the Needle-guided Bracket ... 13-34 13.2.8 Clean and Disinfect the Needle-guided Bracket ... 13-37 13.2.9 Storage and Transportation ... 13-38 13.2.10 Disposal ... 13-38 13.3 Middle Line... 13-38

14 Battery ... 14-1 14.1 14.2 14.3 14.4 14.5 14.6 14.7

Overview ... 14-1 Precautions ... 14-2 Installing and Removing the Batteries ... 14-2 Battery Status Indicator... 14-3 One Full Discharge / Charge Cycle... 14-3 Checking Battery Performance ... 14-4 Battery Disposal ... 14-4

15 Acoustic Output ... 15-1 15.1 Concerns with Bioeffects ... 15-1 15.2 Prudent Use Statement... 15-1 15.3 ALARA Principle (As Low As Reasonably Achievable) ... 15-1 15.4 MI/TI Explanation ... 15-2 15.4.1 Basic Knowledge of MI and TI ... 15-2 15.4.2 MI/TI Display ... 15-3 15.5 Acoustic Power Setting... 15-3 15.6 Acoustic Power Control ... 15-4 15.7 Acoustic Output ... 15-4 15.7.1 Derated Ultrasonic Output Parameters ... 15-4 15.7.2 Limits of Acoustic Output ... 15-5 15.7.3 Differences between Actual and Displayed MI and TI... 15-5 15.8 Measurement Uncertainty... 15-6 15.9 References for Acoustic Power and Safety ... 15-6

16 Guidance and Manufacturer’s Declaration... 16-1 17 System Maintenance ... 17-1 17.1 Daily Maintenance ... 17-1 17.1.1 Cleaning the System ... 17-1 17.1.2 Checking Transducer ... 17-3 17.1.3 Backup of the System Hard Drive... 17-3 17.2 Maintenance Checks by Service Engineer ... 17-3 17.3 Consumables and Periodic Part Replacement ... 17-3 17.4 Troubleshooting... 17-3

vi

Appendix A

Electrical Safety Inspection ...A-1

Appendix B

iWorks (Auto Workflow Protocol) ...B-1

© 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is 2019-03.

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. , and 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. This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents: http://www.mindrayna.com/patents

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:   

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.

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.

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 www.mindray.com

Website: E-mail Address: Tel:

[email protected]

Fax:

+86 755 26582680

+86 755 81888998

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

II

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. 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 this diagnostic ultrasound system Z6 and the compatible probes. 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.

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

2.

U.S.A. Federal Law restricts this device to sale by or on the order of a physician.

III

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 

  

NOTE:

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. 1.

The manuals in CD are the manuals translated into languages other than English according to English manuals.

2.

When you find that the contents of the manuals in CD are NOT consistent with the system or English manuals, please ONLY refer to the corresponding English manuals.

3.

The accompanying manuals may vary depending upon the specific system you purchased. Please refer to the packing list.

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:     

IV

<Buttons>: The angular bracket indicates buttons, knobs and other controls 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>, or click it on the menu. [Items in Menu][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.

1

Safety Precautions

1.1

Safety Classification



According to the type of protection against electric shock: CLASS I EQUIPMENT WITH EXTERNAL POWER SUPPLY + CLASS I EQUIPMENT WITH INTERNAL POWER SUPPLY



According to the degree of protection against electric shock: Type-BF applied part



According to the degree of protection against harmful ingress of water: Main unit: IPX0 Probes: IPX7 Footswitch: 971-SWNOM (2-pedal or 3-pedal) belongs to IP68



According to the degree of safety of application in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE: EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE



According to the mode of operation: CONTINUOUS OPERATION



According to the installation and use: PORTABLE EQUIPMENT MOBILE EQUIPMENT (configured with trolley)

1.2

Meaning of Signal Words

In this manual, the signal words" DANGER”, “ WARNING”, “ CAUTION”, “NOTE” and "Tips" 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 DANGER

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

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

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

NOTE

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

Tips

Important information that helps you to operate the system more effectively.

Safety Precautions 1-1

1.3 Symbol

Meaning of Safety Symbols Description Type-BF applied part. The ultrasound probes connected to this system are type-BF applied parts. Caution. Patient/user infection due to contaminated equipment. Be careful when performing the cleaning, disinfection and sterilization. Patient injury or tissue damage from ultrasound radiation. It is required to practice ALARA when operating ultrasound system.

1.4

Safety Precautions

Please observe the following precautions to ensure patient and operator’s safety when using this system.

DANGER:

WARNING:

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.

Do connect the 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 protective grounding performance, and cause the leakage current to exceed safety requirements. Use the cable provided with this system to connect the printer. Other cables may result in electric shock. You must use the power adapter provided with the system; otherwise electric shock may result. You can only adopt the power supply method provided by Mindray, other power supply modes (e.g. using a UPS) may result in electric shock.

2.

3.

1-2 Safety Precautions

Connect the protective grounding conductor before turning ON the system. Disconnect the grounding cable after turning OFF the system. Otherwise, electric shock may result. For the connection of power and grounding, follow the appropriate procedures described in this operator’s manual. Otherwise, there is risk of electric shock. DO NOT connect the grounding cable to a gas pipe or water pipe; otherwise, improper grounding may result or a gas explosion may occur.

4.

Before cleaning the system, disconnect the power cord from the outlet. System failure and electric shock may result.

5.

This system is not water-proof designed. Do Not use this system in any place where water or any liquid leakage may occur. If any water is sprayed on or into the system, electric shock or device malfunction may result. If water is accidentally sprayed on or into the system, contact Mindray Customer Service Department or sales representative.

6.

Do not use a transducer that has a damaged, scratched surface, or exposed wiring of any kind. Immediately stop using the transducer and contact Mindray Customer Service Department or sales representative. There is risk of electric shock if using a damaged or scratched transducer.

7.

DO NOT allow the patient to contact the live parts of the ultrasound system or other devices, e.g. signal I / O ports. Electric shock may occur.

8.

Do not use an aftermarket probe other than those specified by Mindray. The probes may damage the system causing a profound failure, e.g. a fire in the worst case.

9.

Do not subject the transducers to knocks or drops. Use of a defective transducer may cause an electric shock.

10. Do not open the covers and front panel of the system. Short circuit or electric shock may result when the system hardware is exposed and powered on. 11.

Do not use this system when any digital device such as a high-frequency electrotome, high-frequency therapeutic device or defibrillator is applied already. Otherwise, there is a risk of electric shock to the patient.

12. When moving the system, you should first fold the keyboard, disconnect the system from other devices (including probes) and disconnect the system from the power supply. 13. 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 IEC 60601-1-1.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 IEC 60601-1-1.If you have any questions regarding these requirements, consult your sales representative.

Safety Precautions 1-3

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

CAUTION:

1.

Precautions concerning clinical examination techniques:  

2.

Malfunctions due to radio wave: 



3.

4. 5.

This system must be used only by qualified medical professionals. 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. 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. If a person brings a device that generates radio waves near the system, ask him / her to immediately turn OFF the device.

Precautions concerning movement of the system:  When you place the system on the mobile trolley and move them together, you must secure all objects on the mobile trolley to prevent them from falling. Otherwise you should separate the system from the mobile trolley and move them individually. When you have to move the system with the mobile trolley upward or downward the stairs, you must separate them first and then move them individually.  Object placed on the monitor may fall and injure an individual when moving.  Fasten and fully secure any peripheral device before moving the system. A loose peripheral device may fall and injure an individual. DO NOT expose the system to excessive vibration through transportation. Mechanical damage may result. 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.

6.

1-4 Safety Precautions

Always keep the system dry. Avoid transporting this system quickly from a cold place to a warm place; otherwise condensation or water droplets may form allowing a short circuit and possible electric shock.

7.

If the circuit protector is tripped, it indicates that the system or a peripheral device was improperly shut down and the system is unstable. You cannot repair the system under this circumstance and must call the Mindray Customer Service Department or sales representative.

8.

There is no risk of high-temperature burns during normal 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. Do not apply the transducer to the same region on the patient for a long time. Apply the transducer only for a period of time required for the purpose of diagnosis.

9.

The 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, which will not only harmful to the human body, but also damage the accessory.

10. It is necessary to press [End Exam] to end the current scan that is in progress and clear the current Patient Information field. Otherwise, new patient data may be combined with the previous patient data. 11.

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.

12. If the system is powered off improperly during operation, it may result in data damage of the system’s hard disk or system failure. 13. Do not use the system to examine a fetus for a long period of time. 14. 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. 15. It is recommended to only use the video devices specified in this manual. 16. Do not use gel, disinfectant, probes, probe sheath or needle-guided brackets that are not compatible with the system. 17. Read the Acoustic Output Principle in the operation manual carefully before operate this system on clinical examination. 18. Please use the ultrasound gel compliant with the relevant local regulations.

Safety Precautions 1-5

19. DO NOT touch the Signal I/O ports if in contact with the patient; otherwise patient injury may result. 20. The ultrasound system can be powered by connecting to mains power supply or powered by internal battery, if you have any doubt with stability of mains power protective grounding, please use internal battery.

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 a while. If the system is turned ON immediately after being turned OFF, the system may not be rebooted properly and could malfunction.

6.

Remove ultrasound gel from the face of a probe when the examination is complete. Water in the gel may enter the acoustic lens and adversely affect the performance and safety of the transducer.

7.

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

8.

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

9.

If the system is used in a small room, the room temperature may rise. Please provide proper ventilation and free air exchange.

10.

To dispose of the system or any part, contact Mindray Customer Service Department or sales representative. Mindray is not responsible for any system content or accessories that have been discarded improperly. Mindray is not responsible for any system content or accessories that have been discarded improperly.

11.

Electrical and mechanical performance may be degraded due to long usage (such as current leakage or distortion and abrasion), the image sensitivity and precision may become worse too. To ensure optimal system operations, it is recommended that you maintain the system under a Mindray service agreement.

12.

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

1-6 Safety Precautions

13.

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.

14.

The system should be powered by battery when the integrality and reliability of the protective grounding of external power supply is indeterminate.

15.

The replaceable fuse is inside the chassis. Refer replacing job to Mindray service engineers or engineers authorized by Mindray only.

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

WARNING:

CAUTION:

1.

The ultrasonic probe is only for use with the specified ultrasonic diagnostic system. Please refer to the “2.5.2 Probes Available” to select the proper probe.

2.

The ultrasonic probe must be used only by qualified professionals.

3.

Confirm that the probe and cable are normal before and after each examination. Electrical shock may result from a defective probe.

4.

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

5.

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

6.

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.

7.

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

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. And manage the ultrasound gel properly to ensure that it does not become a source of infection.

3.

In normal diagnostic ultrasound mode, there is no danger of a normal-temperature 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 transducer. If the carrying case is used for storage, it may become a source of infection.

5.

It is required to practice ALARA when operating ultrasound system. Minimize the acoustic power without compromising the quality of images.

Safety Precautions 1-7

6.

The probe and accessories supplied with it are not delivered disinfected or sterilized. Sterilization (or highlevel disinfect) before use is required.

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.

The probe sheath contains natural rubber that can cause allergic reactions in some individuals.

Do not use pre-lubricated condoms as a sheath. Lubricant 10. may not be compatible with the transducer material and damage may result. Transducer damage may be caused by inappropriate gel, detergent or cleanser: 11.

NOTE:

1.

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.

Read the following precautions to prevent the probe from malfunction:  

1-8 Safety Precautions

Clean and disinfect the transducer before and after each examination. 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 transducer from being damaged, do not use it where it will be exposed to:  Direct sunlight or X-rays  Sudden changes in temperature  Dust  Excessive vibration  Heat generators Use the probes under the following ambient conditions:  Ambient temperature: 0°C ~ 40°C  Relative humidity: 30% to 85% (no condensation)  Atmospheric pressure: 700 hPa ~ 1060 hPa Use the probe 7LT4P under the following ambient conditions:  Ambient temperature: 0°C ~ 40°C  Relative humidity: 25% to 90% (no condensation)  Atmospheric pressure: 550 hPa ~ 1060 hPa Use the probe P7-3P under the following ambient conditions:  Ambient temperature: 10°C ~ 40°C  Relative humidity: 30% to 85% (no condensation)  Atmospheric pressure: 700 hPa ~ 1060 hPa Use the probe D6-2P under the following ambient conditions:   

3.

1.5

Ambient temperature: 18°C ~ 30°C Relative humidity: 20% to 85% (no condensation) Atmospheric pressure: 700 hPa ~ 1060 hPa

Repeated disinfection will eventually damage the probe, please check the probe's performance periodically.

Latex Alert

When choosing a probe sheath, it is recommended that you directly contact CIVCO for obtaining probe sheath, 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

WARNING:

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

Safety Precautions 1-9