Clover series User Manual Rel 1.0 Dec 2015

Statement Wisonic reserves the right of final interpretation to this Manual. The content of this Manual is subject to change without prior notice. Only if the following requirements are met, Wisonic will be responsible for the safety, reliability and performance of the product, i.e.: 

Assembly, expansion, re-adjustment, improvement and repair should only be performed by qualified personnel approved by Wisonic;



All the replaced parts and supported accessories and consumables relate to the maintenance shall be originally from Wisonic or others approved by Wisonic;



DO NOT make changes or modifications to the software or hardware of this system



The electrical equipment complies with relevant standards and the requirements of this Manual;



The product is operated in accordance with this Manual.

ii Introduction

File number: H-7100-00-40048

After-sales Service Unit Name: Shenzhen Wisonic Medical Technology CO., LTD. Customer Service Department Address: 5th Floor, NO.6 Building, Ping Shan Technology Park, Taoyuan Street, Nanshan District, Shenzhen，China Postal Code: 518055 Website: www.wisonic.cn Email: info@ wisonic.cn Tel: + 86 755 86007788 Fax: +86 755 86007799

File number: H-7100-00-40048

Introduction iii

Preface Notice This User Manual is the necessary instructions for the safe use of this product. This Manual introduces the use, properties, method of operation, safety information and intended use of the Clover series ultrasound system in details. Before using the product, please carefully read and understand the contents of this Manual, and abide by the method of operation stated in this Manual in order to ensure the safety of patients and operators. This User Manual is a major component of the product, and should always be placed near the product for easy reference.

Object of Application This User Manual is intended for professional clinical staff or personnel with experience in the use of ultrasound diagnostic equipment. The readers should have knowledge and work experience in medical procedures, practices and terminology of ultrasound diagnosis.

Illustration All the illustrations in this user Manual are for reference only. The menus, settings and parameters of the illustrations may be different from your actual currently use system. The content varies depending on the software version, preset settings and optional configuration.

iv Introduction

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Contents Contents ... v Intellectual Property Statement ... XI

1

Introduction ... 1-1 Attention ... 1-1 Warranty ... 1-1 Exemptions... 1-1 Company Contact ... 1-2 Important Information ... 1-3 About This Manual ... 1-4

2

3

Safety Precautions... 2-5 2.1

Precaution Levels ... 2-5

2.2

Safety Classification ... 2-5

2.3

Important Safety Considerations ... 2-6

2.4

Patient Safety ... 2-6

2.5

Personnel Safety ... 2-8

2.6

General Caution ... 2-10

2.7

Symbols ... 2-10

System Overview ... 3-1 3.1

Product and Model Code ... 3-1

3.2

Intended Use ... 3-1

3.3

Contraindication ... 3-1

3.4

Product Specifications ... 3-2

3.5

4

3.4.1

External Dimensions and Weight ... 3-2

3.4.2

Imaging Modes ... 3-2

3.4.3

Power supply ... 3-2

3.4.4

Environmental Conditions ... 3-3

System Configuration ... 3-3 3.5.1

Standard Configuration ... 3-3

3.5.2

Options ... 3-4

3.6

Introduction of Each Unit ... 3-6

3.7

Mobile trolley ... 3-8

3.8

Console Overview ... 3-10

Preparing the System ... 4-1 4.1

Site Requirement... 4-1

4.2

Move/Posit System... 4-1

4.3

Power Supply ... 4-2

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Introduction v

4.4

4.5

4.6

5

Connecting the External Power Supply ... 4-2

4.3.2

Powered by Batteries ... 4-3

Powering the System ... 4-3 4.4.1

Power ON ... 4-3

4.4.2

Power OFF ... 4-4

4.4.3

Sleep ... 4-4

Battery ... 4-5 4.5.1

Installing and Removing the Battery ... 4-7

4.5.2

Battery Status Indicator ... 4-8

4.5.3

Checking Battery Performance ... 4-8

4.5.4

Battery Disposal... 4-8

4.5.5

Recycling Battery ... 4-9

Connecting /Disconnecting a Probe ... 4-9 4.6.1

Connecting a Probe ... 4-9

4.6.2

Disconnecting a Probe ... 4-10

4.7

Graph /Text printer... 4-10

4.8

Video Printer ... 4-12

4.9

Monitor Display... 4-12 4.9.1

Basic Screen ... 4-12

4.9.2

Basic Operations of Screens ... 4-18

Preparing for an Exam ... 5-1 5.1

Begin an Exam ... 5-1

5.2

Begin a New Patient ... 5-1

5.3

6

4.3.1

5.2.1

New Patient Information ... 5-2

5.2.2

Retrieve Patient Information ... 5-5

Select an Exam and Probe ... 5-7 5.3.1

Selecting an Exam ... 5-7

5.3.2

User-Defined Exam ... 5-7

5.3.3

Selecting a Probe ... 5-8

5.3.4

Ending a Patient Exam ... 5-9

Optimizing Image ... 6-1 6.1

Imaging Modes Controls ... 6-1

6.2

Image Adjustment... 6-2

6.3

Optimizing B Mode Image ... 6-4

6.4

6.3.1

Typical B Mode Exam Protocol... 6-4

6.3.2

B Mode Parameters ... 6-4

6.3.3

Controls ... 6-5

Optimizing M Mode Image ... 6-10 6.4.1

Typical M Mode Exam Protocol ... 6-10

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6.5

6.6

6.7

6.8

7

M Mode Parameters ... 6-10

6.4.3

Controls ... 6-11

Color Mode Image ... 6-12 6.5.1

Typical Color Mode Exam Protocol ... 6-12

6.5.2

Color Mode Parameters ... 6-13

6.5.3

Controls ... 6-13

Optimizing Power Mode Image ... 6-17 6.6.1

Typical Power Mode Exam Protocol ... 6-17

6.6.2

Power Mode Parameters ... 6-18

6.6.3

Power Mode Image Optimization ... 6-18

Optimizing PW/CW Doppler Mode ... 6-19 6.7.1

Typical PW / CW Mode Exam Protocol ... 6-19

6.7.2

PW/CW Mode Parameters ... 6-20

6.7.3

Controls ... 6-21

Optimizing Holo PW Doppler Mode ... 6-25 6.8.1

Typical Holo PW Mode Exam Protocol ... 6-25

6.8.2

Holo PW Mode Parameters ... 6-26

6.8.3

Controls ... 6-27

Scanning & Display ... 7-30 7.1

7.2

7.3

7.4

8

6.4.2

Display ... 7-30 7.1.1

ReadZoom ... 7-30

7.1.2

Write Zoom ... 7-30

7.1.3

Dual Display... 7-31

7.1.4

FZoom (Full-screen Zoom) ... 7-31

7.1.5

Freezing an Image ... 7-31

Using Cine ... 7-32 7.2.1

Activating Cine Review ... 7-32

7.2.2

Cine and Monitor Display ... 7-32

Annotating an Image ... 7-34 7.3.1

Adding Comments ... 7-34

7.3.2

Comment Menu ... 7-34

7.3.3

Moving Comments ... 7-35

7.3.4

Deleting Comments ... 7-35

Body Marks ... 7-36 7.4.1

Menu for Body Marks ... 7-36

7.4.2

Adding Body Marks ... 7-36

7.4.3

Moving Body Marks ... 7-37

7.4.4

Deleting Body Marks ... 7-37

Measurement... 8-1

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Introduction vii

8.1

Location of Measurement Controls ... 8-1

8.2

Measurement Accuracy ... 8-2

8.3

Measurement and Calculation Setup ... 8-3 8.3.1

Measurement Menu Setup ... 8-3

8.3.2

Measurement Advanced Setup ... 8-13

8.3.3

OB Table ... 8-18

8.3.4

Mode Measurements ... 8-30

8.4

Measure Tools ... 8-39

8.5

Generic Measurements ... 8-42

8.6

Abdomen ... 8-44

8.7

OB ... 8-49

8.8

Gynecology ... 8-61

8.9

Small Parts ... 8-66

8.10 Cardiology ... 8-69 8.11 Vascular ... 8-87 8.12 Urology ... 8-92 8.13 Pediatrics ... 8-96 8.14 Report ... 8-97

9

Patient Data Management ... 9-1 9.1

9.2

Patient Information Management ... 9-1 9.1.1

Enter Patient Information ... 9-1

9.1.2

Patient Information Setting ... 9-1

Image File Management ... 9-2 9.2.1

Memory Media ... 9-2

9.2.2

Image File Formats ... 9-2

9.2.3

Image Storage Preset ... 9-3

9.2.4

Saving Images to the System ... 9-3

9.2.5

Quickly Saving Images to USB Flash Drive ... 9-4

9.2.6

Quickly Saving Full Screen Image to the System ... 9-4

9.2.7

Thumbnails ... 9-5

9.2.8

Image Review and Analysis ... 9-5

9.2.9

Sending Image File ... 9-8

9.3

Report Management ... 9-9

9.4

Patient Data Management (Station) ... 9-10

9.5

9.4.1

Viewing Patient Information ... 9-10

9.4.2

Searching a Patient ... 9-11

9.4.3

Patient Data Management ... 9-11

9.4.4

Examinations ... 9-12

W +... 9-13

viii Introduction

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9.5.1

W + Advanced Search ... 9-13

9.5.2

W + Search Results... 9-13

9.5.3

Thumbnail Review ... 9-14

10 Customizing Your System ... 10-1 10.1 System Preset ... 10-1 10.1.1 General ... 10-2 10.1.2 Imaging ... 10-3 10.1.3 Key Config ... 10-4 10.1.4 Biopsy ... 10-6 10.1.5 Security ... 10-7 10.2 Exam Preset ... 10-1 10.2.1 Preset ... 10-1 10.2.2 Application configuration ... 10-2 10.3 Peripheral Preset... 10-2 10.4 Network Preset ... 10-4 10.4.1 TCP/IP ... 10-4 10.4.2 DICOM ... 10-5 10.5 Maintenance ... 10-9 10.5.1 About ... 10-9 10.5.2 Exporting Setup Data ... 10-10 10.5.3 Importing Setup Data ... 10-10

11 Probes and Biopsy ... 11-1 11.1 Probe ... 11-1 11.1.1 Name and Function of Each Part of the Probe ... 11-3 11.1.2 Orientation of the Ultrasound Image and the Probe Head ... 11-4 11.1.3 Procedures for Operating ... 11-4 11.1.4 Wearing the Probe Sheath ... 11-8 11.1.5 Probes Cleaning and Disinfection ... 11-9 11.2 Biopsy ...11-11

12 System Maintenance ... 12-1 12.1 Daily Maintenance ... 12-1 12.1.1 Cleaning the System ... 12-1 12.1.2 Checking the Probe ... 12-2 12.1.3 Backup of the System Hard Drive ... 12-2 12.2 Maintenance Checks by Service Engineer ... 12-2 12.3 Consumables and Periodic Part Replacement ... 12-3 12.4 Troubleshooting ... 12-3

13 Acoustic Output ... 13-1

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Introduction ix

13.1 Concerns with Bioeffects ... 13-1 13.2 Prudent Use Statement ... 13-1 13.3 ALARA Principle (As Low As Reasonably Achievable) ... 13-1 13.4 MI/TI Explanation ... 13-2 13.4.1 Basic Knowledge of MI and TI ... 13-2 13.4.2 MI/TI Display ... 13-3 13.5 Acoustic Power Setting ... 13-4 13.6 Acoustic Power Control ... 13-5 13.7 Acoustic Output ... 13-6 13.7.1 Derated Ultrasonic Output Parameters ... 13-6 13.7.2 Limits of Acoustic Output ... 13-6 13.7.3 Differences between Actual and Displayed MI and TI ... 13-7 13.8 References for Acoustic Power and Safety ... 13-8

14 Guidance and Manufacturer’s Declaration... 14-1 15 Appendix ... 15-1 15.1 OB Reference... 15-1 15.2 Cardiac Reference ... 15-6

x Introduction

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©2015 Shenzhen Wisonic Medical Technology Co., Ltd. All rights Reserved. For this Basic user manual, the issue date is 2016-03.

Intellectual Property Statement SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD (hereinafter called Wisonic) owns the intellectual property rights to this Wisonic 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 Wisonic, or of others. Wisonic 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 Wisonic 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 Wisonic is strictly forbidden. Wisonic, W+, Holo are the trademarks, registered or otherwise, of Wisonic 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.

File number: H-7100-00-40048

Introduction XI

XII Introduction

File number: H-7100-00-40048

1

Introduction

Attention Contents of this manual are subject to change without prior notice.

This manual contains necessary and sufficient information to operate the system safely. Advanced equipment training may be provided by a factory trained Applications Specialist for the agreed-upon time period. Read and understand all instructions in this manual before attempting to use the system. Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions. Disregarding information on safety is considered abnormal use. Not all features or products described in this document may be available or cleared for sale in all markets. Please contact your local Wisonic Ultrasound representative to get the latest information. NOTE: Please note that orders are based on the individually agreed specifications and may not contain all features listed in this manual. NOTE: All references to standards / regulations and their revisions are valid for the time of publication of the user manual.

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 Wisonic'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 Wisonic or repairs by people other than Wisonic authorized personnel.

File number: H-7100-00-40048

Introduction 1-1

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.

Company Contact

Manufacturer:

Shenzhen Wisonic Medical Technology Co., Ltd

E-mail Address:

[email protected]

Tel:

+86 755 86007788

Fax:

+86 755 86007799

1-2 Introduction

File number: H-7100-00-40048

Important Information 1. Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a transducer. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. For example, in the case of human tissue, an echo is created where a signal passes from an adipose tissue (fat) region to the liver. The echoes return to the transducer where they are converted back into electrical signals.

2. These echo signals are highly amplified and processed by several analog and digital circuits having filters with many frequency and time response options, transforming the high-frequency electrical signals into a series of digital image signals which are stored in memory. Once in memory, the image can be displayed in real-time on the image monitor. All signal transmission, reception and processing characteristics are controlled by the main computer. By selection from the system control panel, the user can alter the characteristics and features of the system, allowing a wide range of uses, from obstetrics to peripheral vascular examinations.

3. Transducers are accurate, solid-state devices, providing multiple image formats. The digital design and use of solid-state components provides highly stable and consistent imaging performance with minimal required maintenance. Sophisticated design with computer control offers a system with extensive features and functions which is user-friendly and easy to use.

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Introduction 1-3

About This Manual CAUTION:

The safety instruction must be reviewed before operation of the unit.

Clover series documentation consists of various manuals: • The user manual provides information needed by the user to operate the system safely. It describes the basic functions of the system, safety features, operating modes, measurements/calculations, probes, OB tables, and user care and maintenance. The Clover series include Clover 50/60/70/50T/60T/w/i/s totally eight model systems. NOTE: Probe information displayed on screen examples does not necessarily reflect the probes available on your ultrasound system. Please refer to the Probes chapter for a listing of available probes and features. • The Release Notes provide precautions and instructions that supplement the user manual. • The Acoustic Power Reference Manual contains Acoustic Output tables. • The User Guide is a condensed user instruction guide. The Clover series manuals are written for users who are familiar with basic ultrasound principles and techniques. They do not include sonographic training or detailed clinical procedures. NOTE: The system cover color varies. NOTE: The screen graphics in this manual are only for illustrational purpose.

1-4 Introduction

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2

Safety Precautions

2.1

Precaution Levels

Icon Description Various levels of safety precautions may be found on the equipment and different levels of concern are identified by one of the following flag words and icons which precede the precautionary statement. Symbol

Meaning Indicates that a specific hazard is known to exist which through

DANGER

inappropriate conditions or actions will cause serious personal injury or death. Indicates that a specific hazard is known to exist which through

WARNING

inappropriate conditions or actions may cause series personal injury or death Indicates that a potential hazard may exist which through inappropriate

CAUTION

conditions or actions may cause minor personal injury, product damage, or property damage.

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.

2.2

Safety Classification

The type of protection against electric shock: CLASS I Equipment The degree of protection against electric shock: Type BF Applied Part The degree of protection against harmful ingress of water The System is ordinary Equipment (IPX0), and the probes belong to IPX7 File number: H-7100-00-40048

Safety Precautions 2-5

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 The mode of operation Continuous operation The installation and use Portable equipment Mobile Equipment (installed on the trolley)

2.3

Important Safety Considerations

The following topic headings (Patient Safety, and Equipment and Personnel Safety) are intended to make the equipment user aware of particular hazards associated with the use of this equipment and the extent to which injury can occur if precautions are not observed. Additional precautions may be provided throughout the manual. Improper use can result in serious injury. The user must be thoroughly

CAUTION:

familiar with the instructions and potential hazards involving ultrasound examination before attempting to use the device. Training assistance is available from Wisonic Medical Systems if needed. The equipment user is obligated to be familiar with these concerns and avoid conditions that could result in injury.

2.4

Patient Safety

WARNING:

The concerns listed can seriously affect the safety of patients undergoing a diagnostic ultrasound examination.

Patient identification Always include proper identification with all patient data and verify the accuracy of the patient's name and ID numbers when entering such data. Make sure correct patient ID is provided on all recorded data and hard copy prints. Identification errors could result in an incorrect diagnosis. The ultrasound system is not meant to be used for long term storage of patient data or images. The user is responsible for the data on the system and a regular backup is highly recommended. If the system is sent for repair, please ensure that any patient information is backed up and erased from the system before shipping. It is always possible during system failure and repair to lose patient data. Wisonic is not responsible for the loss of this data.

2-6 Safety Precautions

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Diagnostic information Equipment malfunction or incorrect settings can result in measurement errors or failure to detect details within the image. The equipment user must become thoroughly familiar with the equipment operation in order to optimize its performance and recognize possible malfunctions. Applications training are available through the local Wisonic representative. Added confidence in the equipment operation can be gained by establishing a quality assurance program.

Mechanical hazards The use of damaged probes can result in injury or increased risk of infection. Inspect probes often for sharp, pointed, or rough surface damage that could cause injury or tear protective barriers. Become familiar with all instructions and precautions provided with special purpose probes.

A damaged probe can also increase the risk of electric shock if conductive solutions come in contact with internal live parts. Inspect probes often for cracks or openings in the housing and holes in and around the acoustic lens or other damage that could allow liquid entry.

Electrical

Become familiar with the probe's use and care precautions outlined in Probes and Biopsy.

Hazard:

Ultrasound transducers are sensitive instruments which can easily be

Caution:

damaged by rough handling. Take extra care not to drop transducers and avoid contact with sharp or abrasive surfaces. A damaged housing, lens or cable can result in patient injury or serious impairment or operation. Ultrasound can produce harmful effects in tissue and potentially result in

Caution:

patient injury. Always minimize exposure time and keep ultrasound levels low when there is no medical benefit. Use the principle of ALARA (As Low As Reasonably Achievable), increasing output only when needed to obtain diagnostic image quality. Observe the acoustic output display and be familiar with all controls affecting the output level. See the Bioeffects section of the Acoustic Output chapter in the Advanced Reference Manual for more information.

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Safety Precautions 2-7

2.5

Personnel Safety

DANGER:

The concerns listed below can seriously affect the safety of equipment and personnel during a diagnostic ultrasound examination.

To avoid injury: • Do not remove protective covers. No user serviceable parts are inside. Refer servicing to qualified service personnel. • Never use any adaptor or converter of a three-prong-to-two-prong

Electrical

type to connect with a mains power plug. The protective earth connection will loosen. • Do not place liquids on or above the console. Spilled liquid may

Hazard:

contact live parts and increase the risk of shock. •The operator shall not touch adaptor DC output and the patient simultaneously. •The user must check that the equipment functions safely and see

that it is in proper working condition before being use

The system must be supplied from an adequately rated electrical circuit. The capacity of the supply circuit must be as specified.

Smoke

&

Fire Hazard

For patient and personnel safety, be aware of biological hazards while performing invasive procedures. To avoid the risk of disease transmission: • Use protective barriers (gloves and probe sheaths) whenever possible. Follow sterile procedures when appropriate.

Biological

• Thoroughly clean probes and reusable accessories after each patient examination and disinfect or sterilize as needed. Refer to Probes and Biopsy for probe use and care instructions.

Hazard

• Follow all infection control policies established by your office, department or institution as they apply to personnel and equipment.

2-8 Safety Precautions

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