TE7 Series Operator Manual Basic Volume V1.0 July 2018

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

1

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

2

System Overview ... 2-1 2.1 2.2 2.3 2.4 2.5 2.6

3

Intended Use ... 2-1 Contraindication ... 2-1 Product Specifications ... 2-1 System Configuration ... 2-2 Introduction of Each Unit ... 2-8 Symbols ... 2-10

System Preparation ... 3-1 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11

4

Safety Classifications ... 1-1 Meanings of Signal Words ... 1-2 Meaning of Safety Symbols ... 1-2 Safety Precautions ... 1-3 Latex Alert ... 1-10 Warning Labels ... 1-11

Move/Position the System ... 3-1 Power ON/OFF ... 3-2 Connecting the Power Cord ... 3-5 Connecting a Probe... 3-6 Connecting the Footswitch ... 3-7 Connecting USB Devices ... 3-7 Installing a Graph/Text Printer... 3-8 Installing a Video Printer ... 3-10 Brightness and Contrast Adjustment ... 3-10 Display Position Adjustment... 3-11 Basic Screen & Operation ... 3-12

Exam Preparation ... 4-1 4.1 4.2 4.3 4.4 4.5

Patient Information ... 4-1 Select Exam Mode and Probe ... 4-8 Select the Imaging Mode ... 4-9 End an Exam... 4-9 Activate an Exam ... 4-9

i

5

Image Optimization ... 5-1 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12

6

Display & Cine Review ... 6-1 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8

7

Basic Operations ... 7-1 General Measurements ... 7-2 Advanced Measurements ... 7-3 Measurement Accuracy ... 7-4

Physiological Signal ... 8-1 8.1 8.2

9

Splitting Display... 6-1 Image Magnification ... 6-1 iZoom (Full Screen View) ... 6-1 Freeze/Unfreeze the Image. ... 6-2 Cine Review ... 6-2 Image Compare ... 6-4 Cine Saving... 6-5 Preset ... 6-5

Measurement ... 7-1 7.1 7.2 7.3 7.4

8

Imaging Mode ... 5-1 B Mode Image Optimization ... 5-4 M Mode Image Optimization ...5-10 Color Mode Image Optimization ...5-13 Power Mode Image Optimization ...5-19 PW/CW Doppler Mode ...5-21 Contrast Imaging ...5-28 Anatomical M Mode...5-35 iScape View (Real-time Panoramic Imaging) ...5-37 TDI ...5-41 Color M Mode ...5-43 3D Imaging...5-44

ECG ... 8-2 Parameters description... 8-3

Annotations and Body Marks ... 9-1 9.1 9.2 9.3 9.4

Annotations ... 9-1 Voice Comments ... 9-3 Body Mark... 9-5 Settings ... 9-5

10 Patient Data Management ... 10-1 10.1 Patient Information Management ...10-1 10.2 Image File Management ...10-1 10.3 Report Management...10-7 10.4 iStation - Patient Data Management ...10-9 10.5 Recycle bin ...10-12 10.6 iStorage ...10-12 10.7 Print ...10-12 10.8 Back Up Files using the DVD Drive ...10-13 10.9 Patient Task Management ...10-14 10.10 Administration ...10-15 10.11 V-Access ...10-23 10.12 Q-Path ...10-24

ii

11 DICOM/HL7 ... 11-1 11.1 11.2 11.3 11.4 11.5 11.6

DICOM Preset ... 11-2 Verify Connectivity ... 11-10 DICOM Services... 11-11 DICOM Media Storage ... 11-16 Structured Report ... 11-17 DICOM Task Management... 11-17

12 Setup... 12-1 12.1 System Preset ... 12-2 12.2 Exam Related Preset... 12-21 12.3 Network Related Preset ... 12-24

13 Probes and Biopsy ... 13-1 13.1 13.2 13.3 13.4

Probes ... 13-1 Biopsy Guide ... 13-14 Middle Line... 13-46 eSpacialNavi ... 13-46

14 DVR Recording ... 14-1 14.1 Recording... 14-1 14.2 Sending Image ... 14-1 14.3 DVR Video Replaying ... 14-1

15 Acoustic Output ... 15-1 15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9

Concerns with Bioeffects ... 15-1 Prudent Use Statement ... 15-1 ALARA Principle (As Low As Reasonably Achievable) ... 15-1 MI/TI Explanation ... 15-2 Acoustic Power Setting... 15-3 Acoustic Power Control ... 15-4 Acoustic Output ... 15-4 Measurement Uncertainty... 15-5 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 17.2 Troubleshooting... 17-5

Appendix A

Wireless LAN ...A-1

Appendix B

Battery ...B-1

Appendix C

Barcode Reader ...C-1

Appendix D

Trolley and Accessories ...D-1

Appendix E

Electrical Safety Inspection ... E-1

Appendix F

iScanHelper ... F-1

Appendix G

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

Appendix H

List of Vocal Commands ...H-1

iii

© 2014-2018 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is 2018-07.

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:   

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, EXTOUCHED 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

II

Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

MindrayBuilding, 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

EC-Representative:

Shanghai International Holding Corp. GmbH(Europe)

Address:

Eiffestraβe 80, Hamburg20537, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

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: (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. The physician is responsible for the results of 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 also be continuously alert to dangers other than those indicated. Mindray shall not be liable for damage or loss resulting from negligence or ignorance of the precautions and operating instructions described in this operator’s manual. 10. If a new manager takes over this system, be sure to hand over this operator’s manual to the new manager.

III

About This Manual This operator’s manual describes the operating procedures for TE7/TE7T/TE7S/TE7 Pro/TE7 Super/TE5/TE5T/TE5S/TE5 Pro/TE5 SuperDiagnostic Ultrasound System and the compatible probes. To ensure safe and correct operation, 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 (see “Safety Precautions”). Please read this operator’s manual before using the system. NOTE:

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

CAUTION:

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

Operator’s Manuals You may receive multi-language manuals on compact disc or paper. Please refer to the English manual for the latest information and registration information. The content of the operator manual, such as screenshots, menus or descriptions, may be different from what you see in your system. The content varies depending on the software version, options and configuration of the system.

Hardcopy Manuals 

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]



Operator’s Manual [Acoustic Power Data and Surface Temperature Data] Contains data tables of acoustic output for transducers.



Operation Note Contains a quick guide for basic system operations.

NOTE:

Manuals on CD are the manuals translated into languages other than English, according to the English manuals. If you find that the contents of the manuals on CD are NOT consistent with the system or the English manuals, refer ONLY to the corresponding English manuals. The accompanying manuals may vary depending on the specific system you purchased. Please refer to the packing list.

IV

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, the following conventions are used to describe the buttons on the display (main screen), items in the menus, buttons in the dialog boxes and some basic operations:   

[Items in menu or on the screen or buttons in dialog box]: square brackets indicate items in menus or on the screen, or buttons in dialog boxes. Tap [Items or Buttons]: tap the corresponding item on the screen. [Items in menu] -> [Items in submenu]: select a submenu item following the path.

Product Differences Product model

TE7

TE7T

TE7S

TE7 Pro

TE7 Super

TE5

TE5T

TE5S

TE5 Pro

TE5 Super

Double Dist

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×

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√

√

√

×

√

Depth

√

√

×

√

×

√

√

×

√

×

Parallel line

√

×

√

√

×

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×

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×

Spline length

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×

×

×

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Feature

V

1

Safety Precautions

1.1 Safety Classifications 

According to the type of protection against electric shock: Class I equipment + internally powered equipment



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



According to the degree of protection against harmful ingress of water: The main unit is rated IPX0 The probes are rated IPX7 The foot switch (can be applied in the operating room) is rated IPX8. The power adapter is rated IPX1.



According to the disinfection and sterilization method(s) recommended by manufacturer: Equipment with disinfection and sterilization method(s) recommended by manufacturer.



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 (when the system is installed on the trolley)



Does the equipment has any defibrillation-proof applied parts: Non-defibrillation-proof applied part



Permanently installed equipment or non-permanently installed equipment: Non-permanently installed equipment

Safety Precautions1-1

1.2 Meanings of Signal Words In this manual, the signal words DANGER, WARNING, CAUTION, NOTE and Tip 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 WARNING CAUTION

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 in death or serious injury. 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 use the system more effectively.

1.3

Meaning of Safety Symbols Symbol

Description Type-BF applied part The ultrasound probes connected to this system are type-BF applied parts. The ECG leads within this system is type-BF applied part. General warning sign. Caution! Patient/user infection due to contaminated equipment. Be careful when performing cleaning, disinfection and sterilization. Patient injury or tissue damage from ultrasonic radiation. The ALARA principle must be practiced when operating the ultrasound system.

1-2Safety Precautions

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 adapter power plug of this system and power plugs of the peripherals to well-grounded 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 use the power supply method provided by Mindray, other power supply modes (e.g. using a UPS) may result in electric shock.

2.

Connect the protective grounding conductor before turning ON the system. Disconnect the grounding cable after turning OFF the system. Otherwise, electric shock may result.

3.

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 protective grounding may result or a gas explosion may occur.

4.

Before cleaning the system, disconnect the power cord from the outlet. Failure to do so may result in system failure and electric shock.

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, power off the system immediately and contact Mindray Customer Service Department or sales representative.

6.

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

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.

Safety Precautions1-3

1-4Safety Precautions

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 probes to knocks or drops. Use of a defective probe 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 simultaneously with equipment such as an electrosurgical unit, high-frequency therapy equipment, or a defibrillator, etc. This would result in a risk of electric shock to the patient.

12.

When moving the system, you should first fold the LCD display, 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 606011 chapter 16 ME System. 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 chapter 16 ME System. If you have any questions regarding these requirements, consult your sales representative.

14.

Prolonged and repeated use of display controls may result in hand or arm nerve disorders for some individuals. Observe the local safety or health regulations concerning the use.

15.

DO NOT contact both the patient and the ultrasound system or the live parts of the ultrasound system (e.g. signal I/O ports). Electric shock may occur.

16.

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

17.

If you have any doubts of the installation or routing of external protective cables, use the internal power supply of the system.

18.

DO NOT put the ultrasound system in any soft materials (e.g. soft cloth or cotton, etc.) in case that the air vent becomes blocked.

19.

Always read and follow carefully the manufacturer instructions on the contrast agent label.

20.

Only use the ECG leads provided with the ECG module; otherwise electric shock may result.

CAUTION:

1.

Precautions concerning clinical examination techniques: 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.

2.

Malfunctions due to radio waves: 



3.

If a device emitting radio waves is used in the proximity of this system, it may interfere with operations. DO NOT use or take any devices transmitting RF signals (such as cellular phones, transceivers and radio controlled products) into the room where the system is located. 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: 

4.

When you place the system on the trolley and move them together, you must secure all objects on the trolley to prevent them from falling. Otherwise you should separate the system from the trolley and move them individually. When you have to move the system with the trolley upward or downward the stairs, you must separate them first and then move them individually.  Object placed on the display may fall and injure an individual when moving.  Confirm that there is no peripheral device connected to the system before moving the system. Otherwise, peripheral device may fall and cause injury. DO NOT expose the system to excessive vibration through transportation. Mechanical damage may result.

5.

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 over current, 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.

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 that the system is unstable. You cannot repair the system under this circumstance and must call the Mindray Customer Service Department or sales representative.

Safety Precautions1-5

8.

There is no risk of high-temperature burns during normal ultrasound examinations. It is possible for the surface temperature of the probe to exceed the body temperature of a patient due to environmental temperature and exam mode combinations. Apply the probe 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 probes 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 be harmful to the human body, but also damage the accessory.

NOTE:

10.

It is necessary to tap [End] in the bottom-left corner of the operating panel to end the current scan that is in progress and clear the current Patient Information field. Failure to do so may result in new patient data being combined with data of the previous patient.

11.

DO NOT connect or disconnect the system’s power cord or its accessories (e.g., a printer or a recorder) 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 needleguided 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.

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.

1-6Safety Precautions

3.

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.

4.

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.

5.

When using or placing the system, keep the system horizontal to avoid imbalance.

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 probe.

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 touch screen; 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.

11.

Electrical and mechanical performance may be degraded due to long period of 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.

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.

Use detachable power supply cord as mains power breaking device. DO NOT set equipment in a place where it is difficult to disconnect the detachable power supply cord！

Safety Precautions1-7

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

WARNING:

CAUTION:

1-8Safety Precautions

1.

The ultrasonic probe is only for use with the specified ultrasonic diagnostic system. Please refer to the 2.4.2Probes and Needleguided Brackets 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 as this may cause electric shock or malfunction.

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.

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

1.

When using the probe, wear sterile gloves to prevent infection.

2.

Be sure to use sterile 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 probe. 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.

6.

The probe and the accessories supplied with it are not delivered disinfected or sterilized. Sterilization (or high-level disinfection) is required before use.

7.

Disposable components (for example the probe sheath, the sterile gloves) are packaged sterile and are single-use only. Do not use if the integrity of the packaging has been violated or if the expiration date has passed. Use disposable components which comply 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.

10.

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

11.

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.

12.

NOTE:

1.

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

2.

The contrast agent used must comply with the relevant local regulations.

Clean and disinfect the probe 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.

Ambient conditions: To prevent the probe 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% ~ 85% (no condensation)  atmosphericpressure:700 hPa~ 1060 hPa. Use the probe L16-4Hs under the following working conditions:  ambient temperature: 10°C~ 40°C  relative humidity:30% ~ 85% (no condensation)  atmospheric pressure:700 hPa~ 1060 hPa. Use the probe SC6-1s, SP5-1s, L11-3VNs, L12-3RCs, L14-5Ws and L9-3s under the following working conditions:  ambient temperature: 0°C~ 40°C  relative humidity:20% ~ 85% (no condensation)  atmospheric pressure:700 hPa~ 1060 hPa. Use the probe L20-5s under the following working conditions:  ambient temperature: 0°C~35°C  relative humidity:15% ~ 80% (no condensation)  atmospheric pressure:700 hPa~ 1060 hPa. Use the probeC4-1s under the following working conditions:   

ambient temperature: 0°C~35°C relative humidity:15% ~90% (no condensation) atmospheric pressure:700 hPa~ 1060 hPa.

Safety Precautions1-9

3.

NOTE:

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

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.

1.5

Latex Alert

When choosing a probe sheath, it is recommended that you directly contact CIVCO for obtaining information regarding probe sheaths, pricing, samples and local distribution. For CIVCO information, please contact the following: CIVCO Medical Instruments Tel: 1-800-445-6741 www.civco.com

WARNING:

1-10Safety Precautions

Allergic reactions in patients sensitive to latex (natural rubber) may range from mild skin reactions (irritation) to fatal anaphylactic shock, and may include difficulty 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).

1.6

Warning Labels

Warning labels are attached to this system to call your attention to potential hazards. The symbol on warning labels indicates safety precautions. The warning labels use the same signal words as those used in the operator’s manual. Read the operator’s manual carefully before using the system. The name, design and meaning of each warning label are described as follows: No. 1.

Warning Labels

Meaning Read this information carefully before using the system.

2.

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

(a) Do not place the system with the mobile trolley 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 trolley.

a

b

3.

(c) When the casters are locked, DO NOT push the trolley.

c

Non-ionizing radiation

Safety Precautions1-11