TH-100 Instruction Manual ingles

TH-100

Full-digital Ultrasound Diagnostic System

Instruction Manual (V1.2)

Precautions for operators and maintenance personnel

Please do read and understand all instructions in this manual before service

Please keep this manual within easy access after use

TEKNOVA Medical Systems Limited

Beijing , China

Instruction Documentation Copyright TEKNOVA Medical Systems Limited

Declaration

Copyright TEKNOVA Medical Systems Limited. All Rights Reserved. The contents of this publication may not be used, copied or duplicated in any form, in whole or in part, without prior written permission of TEKNOVA Medical Systems Limited. TEKNOVA Medical Systems Limited holds the final interpretation for this Instruction Manual. TEKNOVA Medical Systems Limited may revise this publication from time to time without prior notice. TEKNOVA Medical Systems Limited holds the right to make changes in product design and specification without prior notice. If images and objects in this Instruction Manual look different from the real ones because of printing, take the real ones as standard.

Manufacturer and Service Organization

Teknova Medical Systems Limited Address: Teknova Building, 2 Yongjie North Road, Haidian, Beijing 100094, China Service Hotline: 86-10-57682244 Homepage: http://www.teknova.cn/en E-mail: [email protected]

EU Delegate

Name: Raymond Lam Sai Kit Passport No.: 704681471 Addr: Poolse Winglaan 14 9501 Sint-Denijs-Westrem Belgium Tel: 0032-486867374 Fax: 0032-922144708 E-mail: [email protected]

Issuing Record and Document Number

2012.04 V1.2 THH1.452.016SSE

Safety Instructions

I

Safety Instructions

To help you operate TH-100 safely and correctly, this instruction manual also includes descriptions of the structure, setup, maintenance and operation of the machine. Please strictly follow. This equipment is limited to the use by doctors or special examination technicians who are familiar with the operation of the equipment.

Symbols and Definitions in the Manual

Symbols Definitions

This symbol indicates actions or conditions that should be avoided during operation. If not strictly followed, they could lead to personal death or serious injury or serious property damage such as total loss of equipment or indirect danger such as fire.

!Notice

This symbol indicates actions or conditions that should be avoided during operation. If not strictly followed, they could lead to slight or medium personal injury, partly loss of equipment and computer data.

This symbol indicates actions or conditions that are forbidden.

This symbol indicates complementary explanations.

Safety Criterion symbols and definitions

AC

Protective earth (ground)

Safety Instructions

II

Equipotential

Prevent water

Attention! Refer to document

Power off

Power on

OffOnly used in a part of equipment

OnOnly used in a part of equipment

Dangerous voltage

Fan caution Be careful of your hands

Probe connector - B-type parts

Probe connector - BF-type parts

Nonionized radiation

Users responsibility for equipment management

Users (hospitals and clinics) should take responsibilities for the use and maintenance of the equipment. Please do not remodel the equipment without consent of the manufacturer. The manufacturer does not provide warranty on any damages or malfunctions if the equipment

Safety Instructions

III

is modified without prior consent. If any modification is necessary, please consult the manufacturer or authorized organizations in advance.

Prohibition of Equipment Alteration

Please do not alter this equipment without permission of the manufacturer. The manufacturer wont be able to provide warranty service on breakdown or failure due to unauthorized alteration. Please do consult the manufacturer or the manufacturer appointed parties before any necessary alterations.

Stipulations

The following stipulations are made to simplify and standardize wording of this instruction manual. [1] Buttons on the control panel or in the programs are all indicated by. For example,

OKrefers to the confirm button in dialog boxes in the program. [2] Text edit box and multiple-choice box are expressed by [ ]. For example, [name]

indicates a text edit box which names are to be put in. [male] and [Female] indicate multiple choices of man and woman.

[3] Serial number of figures: Serial numbers of figures are compiled in the order of chapter, section and so on. For example, Figure 1.2.4-1 indicates that this is the first figure of Chapter 1, Part 2, Section 4.

[4] Push up, Push down and Push: Refers to pushing menu buttons on the control panel.

[5] Single Click or Click: Use the trackball to move the cursor on the target button and pressSet.

[6] Check: If there is a checkable box in front of a choice button, use the trackball to move the cursor to the box and press Set to check it. For example,

. [7] Uncheck: If there is a checked box in front of a choice button, use the trackball to

move the cursor to the box and press Setto uncheck it. For example, .

[8] Choose or chosen: For multiple-choice menu, such as , roll

the trackball to move the cursor to the target and press Setto choose. For

multi-choice drop-down menu, such as , roll the trackball to move the cursor onto the drop-down box. When the drop-down menu pops up, move the cursor to the target item and press Setto choose.

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IV

[9] Interface Name : Steps of operation to open one interface is linked with a "-". For example, "System Preset - Misc.Tools - Printers," refers to open the "System Preset" interface first, then open the "Misc.Tools" interface, and the "Printers" interface.

Liability Limitation

[1] If the equipment has to be sent back to the manufacturer or the manufacturer authorized organizations for upgrade, modification or repair, please strictly follow the manufacturer designated means of packaging and transportation.

[2] The manufacturer shall not be liable for any failure or damage to the equipment caused due to trouble of other makers equipment.

[3] The manufacturer shall not be liable for any failure or damage to the equipment in the course of servicing and repairing using parts or components other than the manufacturer specified genuine parts.

[4] The manufacturer shall not be liable for failure or damage to the equipment due to non-compliance of the Instruction Manual.

[5] The manufacturer shall not be liable for any damage or loss due to diagnostic result or data obtained from the equipment by any persons who are not familiar with the operation of the equipment.

[6] The manufacture shall not be liable for any failure or damage to the equipment due to the use of the equipment in power or environmental conditions that are not in compliance with what are specified in the Instruction Manual.

[7] The manufacturer shall not be liable for any failure or damage to the equipment caused by force majeure such as earthquake, flood and lightning, etc.

Necessity of Periodical Maintenance

[1] In consideration of the usage and importance of medical devices, its essential to maintain the equipment in the best conditions in terms of safety and reliability. The manufacturer should not only do its best to control product quality in the manufacturing process but also keep the equipment in the best condition in the course of installation. However, safety and reliability of the equipment after delivery and installation must be maintained by the user on a regular basis.

[2] Please perform daily checkup and maintenance according to procedures described in Maintenance Checkup.

[3] After signing warranty contract with the manufacturer or the manufacturer designated organizations, the user of the equipment is entitled to warranty services within the warranty period. If necessary, please contact the manufacturer or designated organizations.

[4] When performing daily check-up periodical maintenance, please keep records of the date, time, person and serviced content.

Safety Instructions

V

Service, Readjustment and Discard as Waste

[1] Service Responsibility When necessary, please entrust the manufacturer or the manufacturer designated organizations to carry out service or readjustment. The service responsibility lies with the person who carries out the service or adjustment.

[2] Entrust of Service If any abnormality occurs, please turn off the power immediately. Please inform the manufacturer of the abnormality and service personnel will come to perform check and service.

[3] Discard When discarding the main system or accessories of this equipment as waste, please contact the manufacturer or the manufacturer designated organizations

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Table of Contents

DECLARATION .......................................................................................................................................................... II

MANUFACTURER AND SERVICE ORGANIZATION .......................................................................................... II

EU DELEGATE ........................................................................................................................................................... II

ISSUING RECORD AND DOCUMENT NUMBER ................................................................................................ II

SAFETY INSTRUCTIONS ........................................................................................................................................... I

SYMBOLS AND DEFINITIONS IN THE MANUAL ............................................................................................................... I SAFETY CRITERION SYMBOLS AND DEFINITIONS ........................................................................................................... I USERS RESPONSIBILITY FOR EQUIPMENT MANAGEMENT ............................................................................................. II PROHIBITION OF EQUIPMENT ALTERATION ................................................................................................................ III STIPULATIONS ............................................................................................................................................................ III LIABILITY LIMITATION ............................................................................................................................................... IV NECESSITY OF PERIODICAL MAINTENANCE ............................................................................................................... IV SERVICE, READJUSTMENT AND DISCARD AS WASTE ....................................................................................................V

TABLE OF CONTENTS ............................................................................................................................................ VI

CHAPTER 1 PRODUCT INTRODUCTION .............................................................................................................. 1

1.1 SYSTEM INTRODUCTION .................................................................................................................................. 1 1.2 SAFETY CATEGORY ......................................................................................................................................... 1

1.2.1 Electrical shock hazard ......................................................................................................................... 1 1.2.2 Water hazard ......................................................................................................................................... 1 1.2.3 Anesthetic gas hazard .......................................................................................................................... 2 1.2.4 Probe Surface Temperature ................................................................................................................. 2

1.3 ENVIRONMENTAL REQUIREMENTS ................................................................................................................... 2 1.3.1 Operation environment ......................................................................................................................... 2 1.3.2 Operation condition ............................................................................................................................... 2 1.3.3 Transportation and storage conditions ................................................................................................ 3 1.3.4 Transportation ....................................................................................................................................... 3 1.3.5 Storage .................................................................................................................................................. 3

1.4 POWER ............................................................................................................................................................ 3 1.4.1 Power connection ................................................................................................................................. 3 1.4.2 Specification of Fuse and Its Substitution ........................................................................................... 4

1.5 INSTALLATION ................................................................................................................................................. 5 1.5.1 Environment Condition ......................................................................................................................... 5 1.5.2 Operation environment ......................................................................................................................... 5 1.5.3 Operation Space ................................................................................................................................... 5

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1.5.4 Space for Ventilation ............................................................................................................................. 5 1.5.5 Power ..................................................................................................................................................... 5 1.5.6 Installation, detaching and placing of probe ........................................................................................ 5 1.5.7 Prevention of Electromagnetic Radiation ............................................................................................ 5 1.5.8 Starting and Shutting down the Equipment ......................................................................................... 5

1.6 PRECAUTIONS IN OPERATION .......................................................................................................................... 7 1.7 PRECAUTIONS FOR ELECTRICAL SAFETY ......................................................................................................... 8 1.8 PRECAUTIONS REGARDING ELECTROMAGNETIC COMPATIBLITY (EMC) ......................................................... 8 1.9 PRECAUTIONS IN ULTRASOND ACOUSTIC POWER OUTPUT .............................................................................. 9 1.10 SCOPE OF APPLICATION ................................................................................................................................... 9 1.11 BIO-EFFECT OF ULTRASOUND EXAMINATION .................................................................................................. 9 1.12 PRACTICING STANDARD .................................................................................................................................. 9 1.13 RATING PLATE AND PROBE LABEL ................................................................................................................. 10

CHAPTER 2 PARAMETERS AND CONFIGURATIONS .................................................................................... 12

2.1 PERFORMANCE PARAMETERS ........................................................................................................................ 12 2.1.1 Probe Parameters ............................................................................................................................... 12 2.1.2 Probe connector ................................................................................................................................. 12 2.1.3 Output devices supported .................................................................................................................. 12 2.1.4 Monitor ................................................................................................................................................. 12 2.1.5 Size ...................................................................................................................................................... 12 2.1.6 Weight .................................................................................................................................................. 12 2.1.7 Display Mode ...................................................................................................................................... 12 2.1.8 Gray scale ........................................................................................................................................... 12 2.1.9 Image Processing ............................................................................................................................... 12 2.1.10 Gain adjustment .................................................................................................................................. 12 2.1.11 CINE Loop ........................................................................................................................................... 12 2.1.12 Measurement and Calculation ........................................................................................................... 13 2.1.13 Storage ................................................................................................................................................ 13 2.1.14 Patient file management ..................................................................................................................... 13 2.1.15 Marks ................................................................................................................................................... 13 2.1.16 Varying frequency scanning ............................................................................................................... 13 2.1.17 Image direction .................................................................................................................................... 13 2.1.18 Image zoom ........................................................................................................................................ 13 2.1.19 Dynamic range .................................................................................................................................... 13 2.1.20 Biopsy Guide Line ............................................................................................................................... 13 2.1.21 System preset ..................................................................................................................................... 14

2.2 SYSTEM CONFIGURATION .............................................................................................................................. 14 2.2.1 Standard configuration ........................................................................................................................ 14 2.2.2 Optional configuration ......................................................................................................................... 14

CHAPTER 3 DAILY MAINTENANCE .................................................................................................................... 15

3.1 PRE-USE EXAMINATION ................................................................................................................................. 15 3.2 IN-USE EXAMINATION ................................................................................................................................... 15

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3.3 PERIODIC EXAMINATION ............................................................................................................................... 15 3.4 SYSTEM DATA BACKUP ................................................................................................................................. 16 3.5 REUSE AFTER LONG-TIME STORAGE ............................................................................................................. 16 3.6 MAINTENANCE OF THE MAIN UNIT ............................................................................................................... 16 3.7 CLEANING OF THE EQUIPMENT...................................................................................................................... 16

3.7.1 Cleaning of the Probe ......................................................................................................................... 16 3.7.2 Cleaning of the Control Panel ............................................................................................................ 17 3.7.3 Cleaning of the System Case ............................................................................................................. 17 3.7.4 Cleaning of the Monitor ....................................................................................................................... 17 3.7.5 Cleaning of the Video Printer ............................................................................................................. 17 3.7.6 Cleaning of the Trackball .................................................................................................................... 18 3.7.7 Cleaning of the DVD/CD Drive ........................................................................................................... 18

3.8 FUNCTION CHECK ......................................................................................................................................... 18 3.9 WASTES DISPOSAL ........................................................................................................................................ 20

CHAPTER 4 USE AND MAINTENANCE OF PROBES ...................................................................................... 21

4.1 USE OF PROBES ............................................................................................................................................. 21 4.1.1 Handling of Probes ............................................................................................................................. 21 4.1.2 Peruse check of the Probe ................................................................................................................. 21 4.1.3 Connect Probe .................................................................................................................................... 22 4.1.4 Protection and Placement of Probe Cable ........................................................................................ 23 4.1.5 Select Probe ........................................................................................................................................ 23 4.1.6 Pre-cautions for the Use of Probe ...................................................................................................... 24

4.2 NOTE ON ENDOCAVITARY PROBE IN GYNECOLOGY MEASUREMENT ............................................................. 24 4.2.1 Vaginal Examination ........................................................................................................................... 24 4.2.2 Rectal Examination ............................................................................................................................. 25

4.3 STORAGE OF PROBE ...................................................................................................................................... 25 4.4 ULTRASOUND COUPLING GEL ....................................................................................................................... 27 4.5 CLEANING AND STERILIZATION OF PROBE ..................................................................................................... 27

4.5.1 Cleaning and sterilization of probe ..................................................................................................... 27 4.5.2 Sterilization .......................................................................................................................................... 27 4.5.3 General cleaning process (non-derogatory) ...................................................................................... 29 4.5.4 Cleaning and sterilization of endocavitary transducer ...................................................................... 29

4.6 NOTE ON PROBE PROTECTION LEVEL ........................................................................................................... 30

CHAPTER 5 PARTS AND FUNCTIONS ............................................................................................................... 31

5.1 MAIN STRUCTURE ......................................................................................................................................... 31 5.2 PERIPHERAL DEVICES ................................................................................................................................... 32

5.2.1 Layout of the peripheral panel ......................................................................................................... 32 5.3 CONTROL PANEL ........................................................................................................................................... 33

CHAPTER 6 INSTRUCTION .................................................................................................................................... 38

6.1 MOVE THE EQUIPMENT ................................................................................................................................. 38 6.1.1 Pre-move Preparation ........................................................................................................................ 38

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6.1.2 Procedures for Moving the Equipment .............................................................................................. 38 6.1.3 Precautions for Moving the Equipment .......................................................................................... 38

6.2 ADJUSTMENT OF MONITOR ........................................................................................................................... 38 6.3 INSTALLATION OF VIDEO PRINTER ................................................................................................................ 39 6.4 STARTING THE EQUIPMENT ........................................................................................................................... 40

6.4.1 Connecting to Power .......................................................................................................................... 40 6.4.2 Starting ................................................................................................................................................ 40

6.5 ADJUSTING EQUIPMENT AND SETTING PARAMETERS .................................................................................... 40 6.6 END OF USE .................................................................................................................................................. 40

CHAPTER 7 OPERATION GUIDE ......................................................................................................................... 41

7.1 SUMMARY ..................................................................................................................................................... 41 7.2 BASIC DISPLAY MODE ................................................................................................................................... 41

7.2.1 Entering and Switch of Basic Mode ................................................................................................ 41 7.2.2 Main Display Screen in B Mode ......................................................................................................... 41 7.2.3 Main Display Screen in B/B Mode ..................................................................................................... 43 7.2.4 Main Display screen in 4B Mode ....................................................................................................... 43 7.2.5 Main Display screen in B/M Mode ..................................................................................................... 44 7.2.6 Main Display screen in M Mode ......................................................................................................... 44

7.3 FUNCTION MENU BUTTONS FOR IMAGE ADJUSTMENT .................................................................................. 45 7.3.1 B Mode Menu in Real Time State ................................................................................................... 45 7.3.2 B/B Mode Menu in Real Time State .................................................................................................. 48 7.3.3 4B Mode Menu in Real Time State .................................................................................................... 49 7.3.4 B/M Mode and M Mode Menu in Real Time State ............................................................................ 49 7.3.5 B Mode Menu in Freeze State ........................................................................................................... 50 7.3.6 Menu Button in B/B, B/M and M mode in Freeze State .................................................................. 51

7.4 FREQUENCY, DEPTH AND ELECTRONIC FOCUS ............................................................................................... 51 7.4.1 Frequency ........................................................................................................................................... 51 7.4.2 Depth ................................................................................................................................................... 52 7.4.3 Focus................................................................................................................................................... 52

7.5 CINE STORE AND CINE SEARCH..................................................................................................................... 52 7.5.1 Image Store ................................................................................................................................. 52 7.5.2 CINE Loop ................................................................................................................................... 52 7.5.3 CINE Store ................................................................................................................................... 53 7.5.4 Image Storage Operation ................................................................................................................... 53 7.5.5 Operation of Cine Store .................................................................................................................... 53

7.6 PAN ZOOM ................................................................................................................................................... 55 7.7 GAIN ADJUSTMENT ....................................................................................................................................... 55

7.7.1 Adjustment of Total Gain .................................................................................................................... 55 7.7.2 TGCTime Gain Control ............................................................................................................... 56

7.8 GUIDE ........................................................................................................................................................... 57 7.9 CALIBRATING THE NEEDLE-GUIDED BRACKET .............................................................................................. 58

CHAPTER 8 SYSTEM PRESET ............................................................................................................................. 59

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8.1 PROBES ......................................................................................................................................................... 60 8.2 GENERAL ...................................................................................................................................................... 61 8.3 DEVICE ......................................................................................................................................................... 64 8.4 NETWORK ..................................................................................................................................................... 68 8.5 DICOM ........................................................................................................................................................ 71 8.6 STORAGE ....................................................................................................................................................... 72 8.7 APPLICATION SETTING .................................................................................................................................. 73

8.7.1 Edit Data-Image .................................................................................................................................. 75 8.7.2 Edit Data - Display .............................................................................................................................. 79 8.7.3 Edit Data - Body Mark ......................................................................................................................... 80 8.7.4 Edit Data - Measurement ................................................................................................................... 84 8.7.5 Edit Data - Annotation ......................................................................................................................... 86

8.8 OBSTETRIC TABLES ....................................................................................................................................... 88 8.8.1 Obstetric Tables InterfaceGA Table .......................................................................................... 88 8.8.2 Obstetric Tables Growth Table ...................................................................................................... 90 8.8.3 Check Table ...................................................................................................................................... 91 8.8.4 Create user-defined Table ............................................................................................................... 92

8.9 FETAL PARAMETER ........................................................................................................................................ 93 8.9.1 Details of the Fetal Parameter Interface ............................................................................................ 93 8.9.2 Set obstetric measurement region .................................................................................................. 96 8.9.3 Set obstetric measurement method ................................................................................................ 97 8.9.4 Calculation Equation ........................................................................................................................... 98

8.10 BACKUP DATA ............................................................................................................................................... 99 8.11 MISC.TOOLS ................................................................................................................................................ 101

8.11.1 Upgrade ............................................................................................................................................. 103 8.11.2 Set Biopsy Guide Line ...................................................................................................................... 104 8.11.3 Printers .............................................................................................................................................. 106

CHAPTER 9 NEW PATIENT .................................................................................................................................. 110

CHAPTER 10 PATIENT DATA .............................................................................................................................. 114

10.1 LIST ............................................................................................................................................................. 115 10.2 TAGS ............................................................................................................................................................ 119 10.3 SEARCH ....................................................................................................................................................... 120 10.4 IMAGES ....................................................................................................................................................... 122 10.5 PATIENT INFORMATION ................................................................................................................................ 125 10.6 REPORT ....................................................................................................................................................... 125 10.7 MEASUREMENT & CALCULATION ............................................................................................................... 127

CHAPTER 11 BASIC MEASUREMENT .............................................................................................................. 128

11.1 BASIC MEASUREMENT METHOD ................................................................................................................. 128 11.1.1 Instruction on relevant measurement buttons ................................................................................. 128 11.1.2 Measure Distance ............................................................................................................................. 129 11.1.3 Measure Angle .................................................................................................................................. 130

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11.1.4 Measure Trace .................................................................................................................................. 130 11.1.5 Measure Ellipse ................................................................................................................................. 131 11.1.6 Measure Volume ............................................................................................................................... 132 11.1.7 Display measurement result .......................................................................................................... 134 11.1.8 Cancel measurement ....................................................................................................................... 134

11.2 MEASURE DISTANCE IN B MODE AND B/B MODE ........................................................................................ 135 11.2.1 Distance Measurement Menu in B Mode and B/B Mode .......................................................... 135 11.2.2 Distance ............................................................................................................................................ 136 11.2.3 Angle ................................................................................................................................................. 136 11.2.4 RatioDistance ........................................................................................................................... 136 11.2.5 StenosisDistance ..................................................................................................................... 138

11.3 MEASURE DISTANCE IN B/M MODE AND M MODE ..................................................................................... 139 11.3.1 Distance measurement menu in B/M, M mode ........................................................................... 140 11.3.2 Heart Rate ........................................................................................................................................ 140 11.3.3 Time ................................................................................................................................................... 141 11.3.4 Slope ................................................................................................................................................. 142 11.3.5 Distance ............................................................................................................................................ 143 11.3.6 RatioDistance ........................................................................................................................... 143

11.4 MEASURE AREA IN B AND B/B MODES ........................................................................................................ 144 11.4.1 Distance measurement menu in B mode and B/B mode ........................................................ 144 11.4.2 Trace ................................................................................................................................................. 145 11.4.3 Ellipse ................................................................................................................................................ 145 11.4.4 Measure Volume ............................................................................................................................. 146 11.4.5 Ratio[TraceArea] .............................................................................................................................. 146 11.4.6 Ratio[TraceGirth] ............................................................................................................................. 148 11.4.7 Ratio[EllipseArea] ............................................................................................................................ 150 11.4.8 Ratio[EllipseGirth] ............................................................................................................................ 151 11.4.9 Stenosis (TraceArea) ...................................................................................................................... 153 11.4.10 Stenosis (TraceGirth) .................................................................................................................. 155 11.4.11 Stenosis [EllipseArea] ................................................................................................................. 156 11.4.12 Stenosis [EllipseGirth]................................................................................................................. 158

CHAPTER 12 GYNECOLOGY MEASUREMENT .............................................................................................. 161

12.1 BRIEF INTRODUCTION TO GYNECOLOGY MEASUREMENT ........................................................................... 161 12.1.1 Introduction to Gynecology Measurement Functions ................................................................ 161 12.1.2 Operation Procedure of Gynecology Measurement ................................................................... 162 12.1.3 Menu Details of Gynecology Measurement ................................................................................ 162 12.1.4 Exit Gynecology Measurement ..................................................................................................... 164

12.2 CONTENT OF GYNECOLOGY MEASUREMENT ............................................................................................... 164 12.2.1 Uterus ................................................................................................................................................ 164 12.2.2 Cervix ................................................................................................................................................ 165 12.2.3 Endometrium .................................................................................................................................... 166 12.2.4 Left Ovary, Right Ovary .................................................................................................................. 166

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12.2.5 L-Follicle, R-Follicle ......................................................................................................................... 167

CHAPTER 13 OBSTETRICS MEASUREMENT ................................................................................................. 168

13.1 BRIEF INTRODUCTION TO OBSTETRICS MEASUREMENT .............................................................................. 168 13.1.1 Ultrasound Examination in Modern Obstetrics ........................................................................... 168 13.1.2 Introduction to obstetrics measurement functions ...................................................................... 169 13.1.3 Operation Procedure of Obstetrics Measurement ...................................................................... 170 13.1.4 Realize Switch Between Calculating GA (gestation age) and Calculating FW (fetal weight) and AFI (amniotic fluid index) Through Obstetrics Measurement Menu ................................................ 171 13.1.5 Exit Obstetrics Measurement ........................................................................................................ 171

13.2 OBSTETRICS MEASUREMENT CALCULATING GA AND EDC ...................................................................... 171 13.2.1 Basic Knowledge of estimating gestation age ............................................................................ 171 13.2.2 Obstetrics Measurement Menu Details for Calculating GA and EDC .................................. 172 13.2.3 Obstetrics Measurement Directly Calculate DGA/EDC .......................................................... 174 13.2.4 Obstetrics Measurement General Description of Calculating DGA and EDC ..................... 175

13.3 OBSTETRICS MEASUREMENT CALCULATE FW AND AFI ........................................................................... 176 13.3.1 Obstetrics Measurement Menu Details of Calculating FW and AFI ...................................... 176 13.3.2 Obstetrics Measurement General Introduction to Calculating AFI ....................................... 178 13.3.3 Obstetrics Measurement General Introduction to Calculating FW ....................................... 178

CHAPTER 14 UROLOGY MEASUREMENT ...................................................................................................... 180

14.1 BRIEF INTRODUCTION TO UROLOGY MEASUREMENT .................................................................................. 180 14.1.1 Introduction to Urology Measurement Functions ........................................................................ 180 14.1.2 Urology Measurement Operation Procedure .............................................................................. 181 14.1.3 Menu Details of Urology Measurement ........................................................................................ 181 14.1.4 Exit Urology Measurement ............................................................................................................. 183

14.2 CONTENT OF UROLOGY MEASUREMENT ..................................................................................................... 184 14.2.1 Prostate V ......................................................................................................................................... 184 14.2.2 Trans Zone V .................................................................................................................................... 185 14.2.3 Bladder V .......................................................................................................................................... 185 14.2.4 Urine V .............................................................................................................................................. 186

14.3 OTHER MEASUREMENTS ............................................................................................................................. 187 14.3.1 Slice V ............................................................................................................................................... 187 14.3.2 HipJ.Angle ........................................................................................................................................ 189

CHAPTER 15 CARDIOLOGY MEASUREMENT ............................................................................................... 192

15.1 BRIEF INTRODUCTION TO CARDIOLOGY MEASUREMENT ............................................................................ 192 15.1.1 Introduction to Cardiology Measurement Functions .................................................................. 192 15.1.2 Operation Procedure of Cardiology Measurement ..................................................................... 193 15.1.3 Menu Details of Cardiac Measurement ........................................................................................ 193 15.1.4 Exit Cardiac Measurement ............................................................................................................. 196

15.2 CONTENT OF CARDIAC MEASUREMENT ...................................................................................................... 196 15.2.1 Measurement Menu, Measured Items, Input Items and Calculated Items of LV-Volume Measurement in B Mode and B/B Mode ...................................................................................................... 196

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15.2.2 Measurement Menu, Measured items, Input Items and Calculated Items of LV-Function Measurement in B Mode and B/B Mode ...................................................................................................... 196 15.2.3 Measurement Menu, Measured Items, Input Items and Calculated Items of B-LV Measurement in B Mode and B/B Mode ...................................................................................................... 197 15.2.4 Measurement Menu, Measured Items, Input Items and Calculated Items of LV-function Measurement in B/M Mode and M Mode ..................................................................................................... 197 15.2.5 Measurement Menu, Measured Items, Input Items and Calculated Items of Volume Measurement in B/M Mode and M Mode ..................................................................................................... 197 15.2.6 Measurement Menu, Measured Items, Input items and Calculated Items of LV-Volume Measurement in B/M Mode and M mode ..................................................................................................... 198 15.2.7 Explanation of Measurement Parameters and the Menu Showing the Parameters ............. 198 15.2.8 Explanation of Calculated Parameters, Formula and the Menu Showing the Calculated Parameters ....................................................................................................................................................... 199

15.3 LV-VOLUME MEASUREMENT IN B MODE AND B/B MODE .......................................................................... 201 15.3.1 Pombo, Teichholz and Gibson ....................................................................................................... 201 15.3.2 S.Plane Ellipse ................................................................................................................................. 202 15.3.3 Biplane Ellipse ................................................................................................................................. 202 15.3.4 Bullet ................................................................................................................................................. 203 15.3.5 Simpson ............................................................................................................................................ 204

15.4 LV-FUNCTION IN B MODE AND B/B MODE ................................................................................................. 205 15.4.1 LV-Pombo, LV-Teichholz and LV-Gibson ..................................................................................... 205

15.5 B-LV MEASUREMENT IN B MODE AND B/B MODE ..................................................................................... 206 15.5.1 Long Axis .......................................................................................................................................... 206 15.5.2 Wall L-Axis ........................................................................................................................................ 206 15.5.3 Short Axis ......................................................................................................................................... 207 15.5.4 Cardio-Apex ..................................................................................................................................... 207

15.6 LV-FUNCTION MEASUREMENT IN B/M MODE AND M MODE ...................................................................... 208 15.6.1 LV-Pombo, LV-Teichholz and LV-Gibson ..................................................................................... 208

15.7 VOLUME MEASUREMENT IN B/M MODE AND M MODE .............................................................................. 209 15.7.1 MVMitral Valve ......................................................................................................................... 209 15.7.2 AVAortic Valve ......................................................................................................................... 209 15.7.3 TVTricuspid Valve .................................................................................................................... 210 15.7.4 PVPulmonary Valve ................................................................................................................. 211

15.8 LV-VOLUME MEASUREMENT IN B/M MODE AND M MODE ........................................................................ 212 15.8.1 Pombo, Teichholz and Gibson ....................................................................................................... 212

CHAPTER 16 MEASUREMENT REPORT .......................................................................................................... 214

16.1 OBSTETRICS REPORT ................................................................................................................................... 215 16.2 GYNECOLOGIC MEASUREMENT REPORT ..................................................................................................... 219 16.3 CARDIAC MEASUREMENT REPORT .............................................................................................................. 221 16.4 UROLOGY MEASUREMENT REPORT ............................................................................................................. 226

CHAPTER 17 MARKS ............................................................................................................................................ 229

17.1 TEXT ........................................................................................................................................................... 229

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17.1.1 Display and Input Text .................................................................................................................... 229 17.1.2 Delete text ........................................................................................................................................ 230 17.1.3 Exit Text ............................................................................................................................................ 230 17.1.4 Text Menu ......................................................................................................................................... 230

17.2 BODY MARK ............................................................................................................................................... 239 17.2.1 Display of Body Mark ...................................................................................................................... 240 17.2.2 Move body mark and probe mark ................................................................................................. 241 17.2.3 Adjust angle of probe mark ............................................................................................................ 241 17.2.4 Exit Body Mark ................................................................................................................................. 241 17.2.5 Body Mark Menu ............................................................................................................................. 242

17.3 ARROW ....................................................................................................................................................... 243 17.3.1 Display and Input Arrow Marks ..................................................................................................... 243 17.3.2 Delete Arrow Mark ........................................................................................................................... 243 17.3.3 Exit Arrow Mark ............................................................................................................................... 243

CHAPTER 18 COMMON QUESTIONS................................................................................................................ 244

18.1 SOME FACILITY FAILURES AND ELIMINATE METHODS .................................................................................. 244 18.2 OTHER FUNCTIONS ...................................................................................................................................... 244 18.3 PUNCTURE GUIDE LINES .............................................................................................................................. 245

18.3.1 Guide line image can not coincide with puncture needles ........................................................ 245 18.3.2 Guide line direction ......................................................................................................................... 245

18.4 OTHERS ....................................................................................................................................................... 245 18.4.1 Customer Service Center ................................................................................................................... 245 18.4.2 Note ................................................................................................................................................... 245

APPENDIX ................................................................................................................................................................ 246

APPENDIX A OBSTETRICS MEASUREMENT REFERENCE ......................................................................................... 246 APPENDIX B FETAL WEIGHT MEASUREMENT FORMULA ....................................................................................... 251 APPENDIX C ACOUSTIC OUTPUT REPORTING TABLE FOR PROBE OF TH-100 ........................................................ 252 APPENDIX D GUIDANCE AND TEKNOVAS DECLARATION ELECTROMAGNETIC EMISSIONS ...................... 265 APPENDIX E GUIDANCE AND TEKNOVAS DECLARATION ELECTROMAGNETIC IMMUNITY ....................... 266 APPENDIX F GUIDANCE AND TEKNOVAS DECLARATION ELECTROMAGNETIC IMMUNITY ....................... 267 APPENDIX G RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND TH-100 ......................................................................................................................................... 268

Chapter 1 Product Introduction

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1.1 System Introduction TH-100 is a economical full-digital black and white ultrasonic diagnostic imaging system. Equipped with advanced high-precision DBF (digital beam former), DRF (dynamic receiving focusing), RDA (real-time dynamic aperture) and dynamic apordization, the system provide images that look more real and richer in details. Together with powerful standard PC platform and ergonomic control panel, the system could easily meet increasing clinical diagnostic demand. Supporting various types of probe including linear and convex, TH-100 can be used in multiple ultrasound diagnosis like abdomen, gynecology, obstetrics, pediatrics, vascular, cardiology and urology. Except for superb image quality, TH-100 also provides users with various measuring functions. In addition to length, area, circumference and volume, it also provides special measurements in obstetrics, gynecology, cardiology and urology. The system is equipped with cine loop, patient report and image management functions. It also supports DICOM3.0. TH-100 is mainly composed of the main system, monitor, convex probe, linear probe(option) and printer(option).

1.2 Safety Category 1.2.1 Electrical shock hazard

Type BF, Class I

When using a Type BF equipment, if connecting the device that is leaking electricity or that is in disorder with the patient, it may cause electrical shock. For this purpose, examinations must be carried out on devices that are used with the ultrasound machine.

1.2.2 Water hazard

-Generic Equipment

Do not use this equipment where it is exposed to water spray or splash since the equipment is not water-proof at all. Do not splash water on or into the equipment to avoid danger such as electrical shock. In the case of splash, please contact the customer service center of the manufacturer.


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1.2.3 Anesthetic gas hazard -This equipment is not to be used in the presence of anesthetic gas mixed with air, O2 or N2O.

Never use this equipment in an atmosphere where inflammable or combustible gas is present since otherwise it may cause explosion.

1.2.4 Probe Surface Temperature

The surface temperature of the probe shall not exceed 41 when the environmental temperature is 25 . The rise in probe surface temperature shall not exceed 16 when the environmental temperature is below 25 .

1.3 Environmental requirements 1.3.1 Operation environment

Please make sure to install and operate the equipment in the following environmental conditions.

-Ambient temperature : 040 -Relative humidity: 90%subject to condensation -Atmospheric pressure: 700hPa~1060hPa

Electromagnetic wave can cause malfunction or breakdown of the equipment. Do not operate the equipment close to heating sources, strong magnetic field or devices generating high-frequency signals. Shielding protections are required when necessary.

1.3.2 Operation condition

This equipment is not an AP/APG category machine, nor the explosion-proof type. Therefore, do not use it in an environment where toxic gas or inflammable gas is present.

1 This equipment is not water-proof. Therefore, please do not use this

equipment in the following environment: Where water or other liquid splash is present Where heat generating devices such as heaters or humidifiers are present where humidity is high where vapor is present where there is saline air

Note: Probe head and probe cable are made to be IP-protected water proof. 2 It is also prohibited to use the equipment in the following places

where it is dusty or sandy where it is subject to excessive shock or vibration


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where electric voltage fluctuates abnormally where electric voltage drops excessively under overload where it is exposed to direct sun shine

3 Please make sure to use the equipment on a horizontal floor. If the equipment is put on a floor tilting more than 10, it may fall down.

1.3.3 Transportation and storage conditions

This equipment should be stored in the below environmental conditions: -Ambient temperature: -1055 -Relative humidity: 8020 -Atmospheric pressure: 500hPa1060hPa Moreover, please make sure to store packaged equipment in an indoor environment where there is no corrosive gas and where it is well ventilated.

Please make sure to use the equipment in a dry environment and avoid water-dripping conditions. When the equipment is moved from a cold environment to a warm one, vapor could condense into water drops and cause short circuit if the equipment is put into use right away. In this situation, please dont turn on the equipment until after having placed it in a warm environment for 4 hours.

1.3.4 Transportation

The packaging carton of the equipment complies with the IEC standard of EU. With simplified vibration protection, the equipment is suitable for transportation by air, railway, road and ship. In the course of transportation, the followings should be avoided, such as rain, snow, inversion and collision, etc.

1.3.5 Storage

-The equipment should be stored in a dry and clean indoor environment. -The indoor environment should be well-ventilated, and free of direct sunshine and

corrosive gas. -If the equipment has been put in storage for over 6 months, it should be taken out of

the packaging, powered on for 4 hours and then put back in the direction indicated on the packaging carton.

-Do not pile up the equipment more than one layer. Do not put the equipment close to floor, walls or roof top.

1.4 Power 1.4.1 Power connection

The power case is shown as below:

!Warning


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Figure1.4.1-1 power case

1 Rated supply input: 110V~240V 2 Frequency: 50/60Hz 3 Rated power Input: 200VA 4 Power cord: The power cord of this equipment is a 3-wire cable with a protective earth terminal. To prevent power shock, please make sure to directly connect the power cord to a 3-wire power outlet with a medical grounding terminal (less than 0.1 of grounding resistance). Please do not use a power outlet which doesnt have a medical grounding terminal.

Electrical power should be maintained stable. The equipment may be subject to damage in uncertain or frequent outages.

1.4.2 Specification of Fuse and Its Substitution

This equipment uses a time-delay fuse. Please use the equipped substitute fuse when changing. The specifications of the fuse is 2A/250V, 5mm20mm2 Please make sure to use the specified fuse. Otherwise, accident would occur.

Figure1.4.2-1 Changing Fuse


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Remove the fuse cover by turning anticlockwise and take out the old fuse. Put in the new fuse and put the fuse cover on by turning clockwise.

1.5 Installation

TH-100 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, TH-100 should be observed to verify normal operation in the configuration in which it will used.

Please make sure to install and operate the equipment in the following conditions:

1.5.1 Environment Condition Please follow the requirements in 1.3.1 Operation Environment.

1.5.2 Operation environment

Please follow the demand in 1.3.2 Operation Condition.

1.5.3 Operation Space Please make sure to leave a space of above 10cm around the equipment.

1.5.4 Space for Ventilation

A fan is equipped in the back of the equipment. Please keep a space of over 10cm in the rear when installing the equipment for ventilation. Otherwise, temperature rise may cause equipment malfunction. Besides, please make sure not to block the vent-hole.

1.5.5 Power

Please follow the requirements in 1.5 Power.

1.5.6 Installation, detaching and placing of probe Please follow the requirements in 4.1 Use of probe.

1.5.7 Prevention of Electromagnetic Radiation

Strong rays or electromagnetic waves will cause mal-operation of the equipment or noises on images. Please make sure to keep the equipment away from such sources of disturbance.

Note that probes used inside the body will be more affected by electronmagnetic radiation than those used ouside the body.

1.5.8 Starting and Shutting down the Equipment


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Figure 1.5.8-1 Control Panel Locked Switch

Figure 1.5.8-2 Boot switch

1. Press the control panel locked switch (whose location is shown in figure 1.5.8-1, and open control panel.

2. Please check if the above operations have been correctly completed.


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3. Plug the system power cord into the power outlet. 4. Put on the general power switch of the equipment (press the power switch on

the power case toward ON). 5. Turn on the boot switch (the position of the boot switch is indicated in Figure

3.2). 6. Press preset to set system preset and all parameters of the system. 7. Save the settings. System installation completed. 8. Close the control pane and press the control panel locked switch to lock it. 9. Turn off the boot switch. Before shutting down, the system will check if the file

system is complete, save all settings from this operation and automatically turn off the power of the equipment.

1.6 Precautions in Operation 1. Do not alter the system or probes. 2. When any abnormality occurs to the equipment, turn off the power switch

immediately; pull the power cord out of the socket. Then, contact the manufacturer or the manufacturer designated organizations.

3. When the equipment is not in use for a long period of time, please turn off the power switch and put on the protective cover.

4. When not performing diagnosis, please set the equipment in the freeze state to prevent the probe from turning bad from running without load.

5. Make sure that the power switch of the equipment is well connected. Let the system run steadily and do not turn the equipment on and off frequently.

6. If the system has to be restarted after being shut down, please wait at least half a minute to do so. Otherwise, intelligent check on the system power would tell that the power is unsteady and therefore refuse to start the system.

7. Please use the manufacturer designated CD-R/W, video printers and digital printers. 8. When working on the CD-R/W, do operate when the drivers access light is turned off.

Otherwise, damage may occur to the driver or the CD disc. 9. Make sure to use reliable CD discs in order to guarantee data safety. 10. Do not block the ventilation outlets on the front panel and the rear panel to prevent

equipment failure. 11. Once the equipment locks itself, please turn off the Boot Switch to automatically

shut down the equipment and do cut off power. If the equipment still couldnt shut down automatically one minute after turning off the Boot Switch, please turn off the General Power Switch on the bottom of the equipment. Then restart the system after half a minute.

12. The manufacturer shall not be held responsible for date loss on the ultrasound equipment, the electronic storage media and the PC which results from mal-operation or accidents. Please do backup important data.

13. Please check and clean the dust filter on the power ventilation outlet once every week.


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14. Do not operate the power switch with figures stuck with ultrasound gel. Wipe the gel off hands before operating the power switch.

15. Please wipe off stains on the system case and control panel with cloth soaked with neutral detergent first, then with soft dry cloth. Never use organic solvent such as a diluting agent.

16. Please refer to the operation manual of the printer for the use and change of consumables such as printing paper and printing ribbon.

17. Do not touch the silica gel buttons on the control panel with figures stuck with liquid containing silicon oil. Otherwise, the silica gel button may swell and make it hard to press down.

18. Please refer to Chapter 4 Use and Maintenance of Probes for precautions on probes.

1.7 Precautions for Electrical Safety 1. According to the type of electrical shock protection, this ultrasound diagnostic

equipment is classified into Category I, Type B/BF of International Medical Electrical Safety Standard IEC60601-1. To prevent electrical shock, please use a socket with 3 protective earth terminals (The earthing resistance should be less than 10).

2. Please do not remove the equipment case that has been fixed with screws. If remove the case and touch the internal of the equipment, there might be danger of electrical shock. If it is necessary to conduct repair or service of the internal, please make sure to contact the manufacturer or the manufacturer designated organizations for professional assistance.

3. Please make sure to remove all electro-cardiological cables on the patient when using operating devices that generate high-frequency waves.

4. Please do not use the electro-cardiology function when patient wears cardiac pacemaker or other devices that may cause electrical stimulation.

1.8 Precautions regarding Electromagnetic Compatiblity (EMC) 1. As a medical electrical equipment, TH-100 needs special precautions regarding

EMC and needs to be installed and put into service according to the EMC information provided in Appendix D, E and F;

2. As a medical electrical equipment, TH-100 can be affected by nearby portable and mobile RF communications equipment. Separation distances need to be used according to the recommendations provided in Appendix G.

Use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Teknova of TH-100 as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of TH-100.


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1.9 Precautions in Ultrasond Acoustic Power Output This ultrasound acoustic power on this equipment is as low as harmless to humans. However, fetuses (particularly those on the early stage of gestation) are sensitive to ultrasound. Therefore, to minimize the negative effect of ultrasound when examining fetuses, please pay attention to these followings: 1. Set the ultrasound acoustic power to the lowest level. If the image quality is not ideal,

improve the image not by lifting ultrasound acoustic power, but by changing sensitivity through turningGainor by adjusting the 8 TGC levers.

2. To avoid unnecessary ultrasound scanning of human body, press Freezeto freeze the image immediately aftering obtaining the image.

3. With the same ultrasound acoustic power, its easier to obtain a clearer figure in M mode than in B mode. Therefore, in M mode, please set the ultrasound acoustic power to the lowest level.

1.10 Scope of Application This equipment is designed to perform analysis and diagnosis of human anatomic cross-section by clinical physicians and other qualified personnel. Its mainly used to conduct ultrasonic diagnosis on visceral organs, superficial tissues, heart and peripheral vascular in chest/breast, abdomen and pelvic cavity.

Ultrasound will hurt human body; Please do not apply the probes of this equipment on scopes not involved in this manual.

1.11 Bio-effect of Ultrasound Examination The US Medical Ultrasound Association has approved the safety of clinical application of ultrasound. Up to date, there has been no reports of negative effect resulting from medical ultrasound examinations. In the mean time, however, the US Medical Ultrasound Association points out that ultrasound examination must be carried out with care. Negative effects may occur in case of ultra large acoustic power.

The ALARA principle must be observed. That is, to lower the acoustic power and reduce the examination duration as far as possible.

1.12 Practicing Standard This equipment is designed and manufactured strictly following the National Standard EU IEC. The environmental test of this equipment complies with the requirements in the Climatical Environment Test II and Mechanical Environment Test II in GB/T14710-1993 Environmental Requirements and Experiment Methods for Medical Electrical Devices.

!Notice

!Notice


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Only technicians from the manufacturer or the manufacturer authorized technicians are allowed to install and test the equipment when delivered to the user. It is prohibited that the user installs the equipment on his/her own.

Please perform pre-use checks and after-use service, periodical checks and cleaning by the following procedures. Install: Put the assembled equipment in a appropriate environment first. Then put

on peripheral devices. Move: Moving of the assembled equipment should be carried out manually.

The equipment may be damaged or break down if it is not transported as specified in this manual. Please contact the manufacturer when the equipment has to be transported on transportation vehicles.

1.13 Rating plate and Probe Label Rating plate is located as shown in the below:

Figure 1.12-1 Rating plate Position

!Notice

!Notice


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Figure 1.12-2 Rating plate

Chapter 2 Parameters and Configurations

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2.1 Performance Parameters 2.1.1 Probe Parameters

Type: Convex Parameter: Nominal frequency :3.5MHz,R=50mm Type: Linear Parameter: Nominal frequency :7.5MHz Type: Endocavity Convex Parameter: Nominal frequency : 6.5MHz,R=10mm

2.1.2 Probe connector Probe connector:2.

2.1.3 Output devices supported USB mobile storage, digital printer, video printer, LAN port(DICOM transmit port).

2.1.4 Monitor

10 line-by-line non-interlaced monitor with high definition and resolution.

2.1.5 Size Control panel open: 648mmLength 297mmWidth 287mmHeight. Control panel closed: 421mmLength 297mmWidth 290mmHeight

2.1.6 Weight 10kg (About).

2.1.7 Display Mode

B, B/B, B/M, M

2.1.8 Gray scale 256 grades

2.1.9 Image Processing

Line Average, Frame Average, Pre Gray, B/W Invert, Enhance, Contrast, Brightness, Gamma.

2.1.10 Gain adjustment

0-100dB adjustable TGC: 8-level adjustment.

2.1.11 CINE Loop

Automatic /manual play


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The CINE Loop frame is determined by system configuration. 2.1.12 Measurement and Calculation

B mode conventional measurement: distance, circumference, area, volume, angle, ratio, stricture ratio and so on. M mode conventional measurement: heart rate, time, distance, distance, speed, stricture ratio and so on. Gynecology measurement: womb, cervix, endometrial, ovary (left and right), ovarian follicle (left and right) and so on. Obstetrics measurement: gestational age, fetus weight, amniotic fluid depth index and so on. Cardiology measurement: left ventricle measurement, left ventricle function, and ventricle thickness evaluation and so on. Urology measurement: displacement volume, bladder capacity, residual urine output and so on. Other measurement: profile measurement, hip joint measurement and so on. Users can customize other measurement.

2.1.13 Storage

Image storage, CINE Loop storage .

2.1.14 Patient file management Medical record management, report printing, image video output (CD-ROM, USB) and data input.

2.1.15 Marks

Character mark, body mark (90 types), arrow mark.

2.1.16 Varying frequency scanning 5-band varying frequency scanning.

2.1.17 Image direction Images could flip up, flip down, flip to left, flip to right and rotate by 90.

2.1.18 Image zoom Local image can be zoomed in and real-time displayed. The zoom radio is adjustable. 2.1.19 Dynamic range

7 level adjustable: 0~120Db.

2.1.20 Biopsy Guide Line Probe corresponding biopsy-guide set up available


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2.1.21 System preset System parameter preset: abdomen, gynecology, obstetrics, superficial, urology, cardiology, self-defining 1~4 Obstetrics formula, text content, Default preset, system upgrade, maintenance tools.

2.2 System configuration 2.2.1 Standard configuration

Main unit Monitor Electronic convex C3612-6MHz, nominal frequency 3.5 MHz, applicable in abdominal examination Accessories: Ultrasound gel holder 1 Probe cable hanger 1 Instruction manual 1 Quick Operation Guide 1 Power cord 1 Fuse 2

2.2.2 Optional configuration

1 Electronic linear array probe: L553, 5-10MHz, nominal frequency 7.5 MHz 2 Endcavitary probe: E663, 4-9MHz, nominal frequency 6.5MHz 3 Electronic micro-convex: M201, 2.5-5 MHz, nominal frequency 3.5MHz 4 Biopsy Guide Line 5 Ultrasound report software: enables editing and printing out of standard

ultrasound examination report 6 CD burning software: enables burning and saving of stored images and CINE

Loop files onto CD discs 7 Dicom 3.0 transmission: namely Digital Imaging Communications in Medicine, a

protocol by which images and other information on different medical equipment communicate with each other. Once the ultrasound equipment is connected to PACS, it could transmit and receive required images and related information through DICOM.

8 Real-time dynamic network transmission 9 Black and white video printer 10 Service tools 11 THI (Tissue Harmonic Imaging) software

Chapter 3 Daily Maintenance

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Please perform pre-use examination, after-use service, periodic checkup and cleaning according to the below regulations.

3.1 Pre-use Examination Examination Period: Daily Please perform the following examination before turning on the power of the equipment. 1 Check the sleeve of the power cord for damage or fall-off to avoid electrical

hazard. 2 Check the sleeve of the probe cable for damage or fall-off and the probe surface

for scratch to avoid electrical hazard. 3 Check the connection of peripheral devices such as the printer, etc. Check if the connected devices are the manufacturer approved ones Check if the power supply of peripheral devices comes from the auxiliary power

socket of the ultrasound equipment Check if the total power supply of the peripherals is within the limit of the auxiliary

power socket of the ultrasound equipment If any abnormalities occur, please contact the service department of the manufacturer or the manufacturer designated organizations.

3.2 In-use Examination Examination Period: Daily Please perform the following examinations after turning on the power of the the equipment 1 Check for abnormal sound or smell of burning. For any abnormalities, cut off the

power, pull the power cord out of the socket and contact the service department. 2 Check if the date and time display on the upper right of the image is correct. If

there is a big error in the date or time display, the PC CMOS battery inside the equipment may have been used up. In that case, please contact the service department of the manufacturer or the manufacturer designated service organizations. Please follow national or local regulations to dispose the detached battery properly.

3.3 Periodic Examination Examination Period: Monthly Please perform the following examination once every month. 1 Check the probe cable and connector for abnormality 2 Check the power cord and other cables for abnormality 3 Check the control panel and keyboard for abnormality


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4 Check the foot wheel brake for abnormality For any abnormalities, please contact the service department of the manufacturer or the manufacturer designated service organizations.

3.4 System Data Backup Operation Period: Monthly If patient data such as images and videos are frequently stored, they would gradually occupy a large internal storage memory. It is suggested to sort out patient data on a periodic basis, output or back up them to external storage media (USB, CD disc), as well as delete those data that have been backed-up to avoid inadequate hard drive memory. Periodic sorting out and backup are of particular importance in consideration of data loss from hard drive damage. Please back up data at least once every month. Please refer to 8.10 Backup Data for details.

3.5 Reuse after Long-time Storage If the equipment hasnt been used for a long time, please confirm that it is able to run normally and safely before using it again.

3.6 Maintenance of the Main Unit The operation environment of the main unit should comply with 1.3 Environmental

Requirements. Turn on the power of the equipment twice, no less than one hour each time, if the

equipment is left unused for a long period of time. Please do not randomly open the case of the equipment to clean the interior, nor

shake or disassemble the interior parts. Shut the equipment down before cleaning the case of the equipment. Clean the

machine with alcohol cotton ball. Do not start and shut down the equipment too often. Wait for at least I minute to

restart after shutting down. The equipment should be placed on a flat floor. Do not put heavy stuff on top of the

machine. Only professional service technicians are allowed to service the equipment. Please perform regular checks on the control panel and keyboard. Check the foot wheel brake on a regular basis.

3.7 Cleaning of the Equipment 3.7.1 Cleaning of the Probe

Operation Period: Daily After the probe is used, wipe off the ultrasound coupling gel with soft paper tissue

or cloth. Otherwise, the probe may change color or deteriorate. Do not wipe the probe with hard paper, cloth or crude paper to prevent the acoustic

lens from being damaged, or to prevent electrical shock.

Documents

TH-100 Instruction Manual ingles