EDAN U60 User manual

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About this Manual
P/N: 01.54.457919
MPN: 01.54.457919016
Release Date: Dec. 2019
© Copyright EDAN INSTRUMENTS, INC. 2018-2019. All rights reserved.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effects on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN.
The electrical installation of the relevant room complies with international standards, and
The equipment is used in accordance with the instructions for use.
Terms Used in this Manual
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.

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Table of Contents
Chapter 1 Introduction................................................................................................................. 1
1.1. Overview.......................................................................................................................... 1
1.2. Features............................................................................................................................ 1
1.3. Indications for Use/Intended Use .................................................................................... 2
1.4. Model............................................................................................................................... 2
1.5. Contraindications............................................................................................................. 2
Chapter 2 Safety Guidance.......................................................................................................... 3
2.1. Warnings and cautions..................................................................................................... 3
2.1.1. Safety Warnings .................................................................................................... 3
2.1.2. Battery Safety........................................................................................................ 8
2.1.3. General Cautions................................................................................................... 9
2.1.4. Network Security Cautions................................................................................. 10
2.2. Labeling Symbols.......................................................................................................... 11
Chapter 3 System Overview...................................................................................................... 14
3.1. Appearance .................................................................................................................... 14
3.1.1. Front View........................................................................................................... 14
3.1.2. Rear View............................................................................................................ 15
3.2. Configuration................................................................................................................. 16
3.2.1. Standard Configuration....................................................................................... 16
3.2.2. Options................................................................................................................ 16
Chapter 4 Installation Instructions............................................................................................. 18
4.1. Environmental Requirements ........................................................................................ 18
4.2. Unpacking Inspection.................................................................................................... 18
4.3. Connecting Procedure.................................................................................................... 18
4.3.1. Installing and Uninstalling a Battery .................................................................. 19
4.3.2. Connecting and Disconnecting Probes ............................................................... 20
4.3.3. Peripheral Connections ....................................................................................... 22
4.3.4. Equipotential Bonding ........................................................................................ 24
4.3.5. Printer Installation............................................................................................... 25
Chapter 5 System Control ......................................................................................................... 26
5.1. Powering On/Off Device............................................................................................... 26
5.2. Examining...................................................................................................................... 28
5.3. Screen Layout................................................................................................................ 29
5.4. Control Panel................................................................................................................. 31
5.4.1. Trackball.............................................................................................................. 31
5.4.2. “0~9” Numeric Keys........................................................................................... 32
5.4.3. Alphabetic Keys.................................................................................................. 32
5.4.4. Function Controls................................................................................................ 32
5.4.5. Imaging Functions............................................................................................... 38
5.5. Menu.............................................................................................................................. 44

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5.6. Dialog Box Operation.................................................................................................... 47
5.7. Presetting ....................................................................................................................... 48
5.7.1. Entering Presetting.............................................................................................. 48
5.7.2. Displaying / Modifying Presetting Parameters................................................... 48
5.7.3. System Preset...................................................................................................... 48
5.7.4. Probe Preset......................................................................................................... 51
5.7.5. Exam Preset......................................................................................................... 52
5.7.6. Image Parameter Preset....................................................................................... 53
5.7.7. Measurement Preset............................................................................................ 57
5.7.8. Comment Preset.................................................................................................. 59
5.7.9. Preset Data .......................................................................................................... 61
5.7.10. Connectivity........................................................................................................ 62
5.7.11. Maintenance........................................................................................................ 63
5.7.12. System Information............................................................................................. 64
5.7.13. User Login........................................................................................................... 64
5.8. Printing .......................................................................................................................... 66
Chapter 6 Operation .................................................................................................................. 68
6.1. Entering or Editing Patient Information........................................................................ 68
6.2. Selecting a Probe and an Examination Type ................................................................. 69
6.3. Selecting an Imaging Mode........................................................................................... 70
6.4. Image Adjustments........................................................................................................ 70
6.5. Generic Measurements and Calculations....................................................................... 78
6.5.1. Generic Measurements in B Mode...................................................................... 79
6.5.2. Generic Measurements in M Mode..................................................................... 88
6.5.3. Generic Measurements in Color/PDI Mode........................................................ 90
6.5.4. Generic Measurements in D Mode ..................................................................... 90
6.6. Application Measurements and Calculations ................................................................ 94
6.7. Worksheet (Report)........................................................................................................ 95
6.8. Comment Function ........................................................................................................ 96
6.9. Body Mark Function...................................................................................................... 99
6.10.Zoom............................................................................................................................ 100
6.11.CINE Review............................................................................................................... 101
6.12.File Management ......................................................................................................... 103
6.12.1. Saving Files....................................................................................................... 103
6.12.2. File Manager ..................................................................................................... 106
6.12.3. Sending Files..................................................................................................... 108
6.13.Needle Guide Function................................................................................................ 110
6.13.1. Installing Needle Guide Bracket........................................................................111
6.13.2. Activating Needle Guide Function ................................................................... 114
6.13.3. To Select the Angle of Needle Guide Line........................................................ 114
6.13.4. To Display or To Hide the Needle Guide Line.................................................. 115
6.13.5. To Adjust the Needle Guide Line...................................................................... 115
6.13.6. Performing Puncture Function.......................................................................... 116
6.13.7. Center Line........................................................................................................ 116

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Chapter 7 Abdominal Measurements & Calculations............................................................. 117
7.1. Measurements and Calculations.................................................................................. 117
7.1.1. Liver.................................................................................................................. 117
7.1.2. Gallbladder........................................................................................................ 117
7.1.3. Pancreatic.......................................................................................................... 118
7.1.4. Spleen................................................................................................................ 118
7.2. Abdominal Report ....................................................................................................... 118
Chapter 8 Obstetric Measurements and Calculations.............................................................. 120
8.1. Obstetric Measurements and Calculations in B Mode ................................................ 120
8.1.1. GS...................................................................................................................... 122
8.1.2. CRL................................................................................................................... 122
8.1.3. NT ..................................................................................................................... 122
8.1.4. BPD................................................................................................................... 123
8.1.5. HC..................................................................................................................... 123
8.1.6. AC..................................................................................................................... 123
8.1.7. FL...................................................................................................................... 124
8.1.8. AFI .................................................................................................................... 124
8.1.9. TAD................................................................................................................... 124
8.1.10. APAD ................................................................................................................ 125
8.1.11. HUM ................................................................................................................. 125
8.1.12. CER................................................................................................................... 125
8.1.13. FTA ................................................................................................................... 126
8.1.14. OFD................................................................................................................... 126
8.1.15. THD .................................................................................................................. 126
8.1.16. FBP.................................................................................................................... 127
8.1.17. EDC Calculation ............................................................................................... 128
8.1.18. EFW Calculation............................................................................................... 129
8.2. Obstetric Measurements and Calculations in PW mode.............................................. 130
8.2.1. FHR................................................................................................................... 131
8.2.2. Umb A............................................................................................................... 131
8.2.3. MCA.................................................................................................................. 131
8.2.4. Fetal AO............................................................................................................ 132
8.2.5. Desc.AO............................................................................................................ 132
8.2.6. Placent A ........................................................................................................... 132
8.2.7. Ductus V............................................................................................................ 133
8.3. Obstetric Measurements and Calculations in M mode................................................ 133
8.4. Results.......................................................................................................................... 133
8.4.1. Growth Curve.................................................................................................... 134
8.4.2. Obstetric Report................................................................................................ 135
Chapter 9 Cardiac Measurements and Calculations................................................................ 137
9.1. Cardiac Measurements and Calculations in M Mode.................................................. 137
9.1.1. LV...................................................................................................................... 141
9.1.2. Mitral Valve....................................................................................................... 143
9.1.3. Aorta.................................................................................................................. 144

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9.1.4. LVMW, LVMWI............................................................................................... 144
9.2. Cardiac Measurements and Calculations in B Mode................................................... 145
9.2.1. LV...................................................................................................................... 148
9.2.2. RV (Right Ventricle Internal Diameter) ............................................................ 151
9.2.3. PA (Pulmonary Artery)...................................................................................... 151
9.2.4. MVA (Mitral Valve Area).................................................................................. 151
9.2.5. AVA (Aortal Valve Area)................................................................................... 151
9.3. Cardiac Measurements in D Mode.............................................................................. 151
9.4. Cardiac Report............................................................................................................. 153
Chapter 10 Gynecology Measurements & Calculations ........................................................... 155
10.1.Measurements and Calculations in B Mode................................................................ 155
10.1.1. UT ..................................................................................................................... 156
10.1.2. Endo .................................................................................................................. 156
10.1.3. OV-Vol .............................................................................................................. 157
10.1.4. FO...................................................................................................................... 157
10.1.5. CX-L ................................................................................................................. 158
10.1.6. UT-L/CX-L........................................................................................................ 158
10.2.Measurements and Calculations in PW Mode............................................................. 159
10.2.1. L UT A .............................................................................................................. 159
10.2.2. R UTA.............................................................................................................. 160
10.2.3. L OV A.............................................................................................................. 160
10.2.4. R OVA.............................................................................................................. 160
10.3.Gynecologic Report..................................................................................................... 161
Chapter 11 Small Parts Measurements & Calculations............................................................. 162
11.1.Measurements and Calculations.................................................................................. 162
11.2.Small Parts Report....................................................................................................... 163
Chapter 12 Urology Measurements and Calculations............................................................... 165
12.1.Measurements and Calculations .................................................................................. 165
12.2.Urologic Report ........................................................................................................... 168
Chapter 13 Peripheral Vascular Measurements & Calculations................................................ 169
13.1.Measurements and Calculations in PW Mode............................................................. 169
13.1.1. CCA .................................................................................................................. 169
13.1.2. ICA.................................................................................................................... 170
13.1.3. ECA................................................................................................................... 170
13.1.4. VertA ................................................................................................................ 170
13.1.5. UPPER .............................................................................................................. 171
13.1.6. LOWER............................................................................................................. 171
13.2.Vascular Report............................................................................................................ 171
Chapter 14 Pediatrics Measurements & Calculations............................................................... 173
14.1.Measurements and Calculations .................................................................................. 173
14.2.Pediatrics Report.......................................................................................................... 173
Chapter 15 Inspection and Maintenance ................................................................................... 175

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15.1.Daily Checklist ............................................................................................................ 175
15.2.Cleaning and Disinfection ........................................................................................... 176
15.2.1. Transducer Cleaning and Disinfection.............................................................. 176
15.2.1.1. Cleaning .................................................................................................177
15.2.1.2. Disinfection............................................................................................177
15.2.1.3. Using Transducers..................................................................................180
15.2.1.4. Storage....................................................................................................182
15.2.2. Needle Guide Bracket Cleaning and Sterilization ............................................ 182
15.2.2.1 Cleaning................................................................................................................... 183
15.2.2.2 Sterilization............................................................................................................. 183
15.2.2.3 Storage..................................................................................................................... 183
15.2.3. System Cleaning and Disinfection.................................................................... 184
15.3.Replacing Fuses........................................................................................................... 187
15.4.Maintenance................................................................................................................. 188
Chapter 16 Transportation and Storage..................................................................................... 189
16.1.Moving the System...................................................................................................... 189
16.2.Storage......................................................................................................................... 189
16.3.Transportation.............................................................................................................. 189
Chapter 17 Troubleshooting...................................................................................................... 190
17.1.Checkup....................................................................................................................... 190
17.2.Troubleshooting........................................................................................................... 190
Chapter 18 Warranty and Service.............................................................................................. 191
18.1.Warranty....................................................................................................................... 191
18.2.Contact information..................................................................................................... 191
Appendix I: Specifications.......................................................................................................... 192
A1.1: Electrical Safety Classifications................................................................................. 192
A1.2: Power Supply............................................................................................................. 192
A1.3: Machine Specifications.............................................................................................. 193
A1.4: Display Specifications................................................................................................ 193
A1.5: General Technical Specifications............................................................................... 193
A1.6: Probe Specifications................................................................................................... 194
A1.7: Operating, Storage and Transportation Environment................................................. 195
A1.7.1.Operating Environment..................................................................................... 195
A1.7.2.Storage and Transportation Environment.......................................................... 195
Appendix II:Ultrasound Intensity and Safety............................................................................. 196
A2.1: Ultrasound in Medicine............................................................................................. 196
A2.2: Ultrasound Safety and theALARA Principle ........................................................... 196
A2.3: Explanation of MI/TI ................................................................................................ 197
A2.3.1.MI (Mechanical Index) ..................................................................................... 197
A2.3.2.TI (Thermal Index)............................................................................................ 198
A2.3.3.Display of MI/TI............................................................................................... 198
A2.4: Acoustic Output ........................................................................................................ 198

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A2.4.1.Factors that Contribute to Uncertainty in the Output Display .......................... 198
A2.4.2.Differences between Actual and Displayed MI/TI............................................ 199
A2.4.3.Measurement Uncertainty................................................................................. 199
A2.5: Operator Control Features......................................................................................... 201
A2.6: Prudent Use Statement.............................................................................................. 201
A2.7: References forAcoustic Output and Safety .............................................................. 202
A2.8: Probe Acoustic Output Parameters List .................................................................... 203
A2.8.1.Test of Probe C5-2b .......................................................................................... 203
A2.8.2.Test of Probe P5-1b........................................................................................... 210
A2.8.3.Test of Probe L15-7b......................................................................................... 218
A2.8.4.Test of Probe C352UB ...................................................................................... 225
A2.8.5.Test of Probe L742UB ...................................................................................... 232
A2.8.6.Test of Probe L1042UB .................................................................................... 239
A2.8.7.Test of Probe E612UB ...................................................................................... 246
A2.8.8.Test of Probe C612UB ...................................................................................... 253
A2.8.9.Test of Probe C6152UB .................................................................................... 260
A2.8.10. Test of Probe C422UB................................................................................... 267
A2.8.11. Test of Probe L552UB................................................................................... 274
Appendix III: Measurement Accuracy................................................................................... 281
AppendixIV: EMCInformation-Guidance and Manufacture’s Declaration .................................................. 282
Appendix V:Order List ............................................................................................................... 288
Appendix VI: Glossary .......................................................................................................... 290

U60 Diagnostic Ultrasound System User Manual Introduction
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Chapter 1 Introduction
1.1.Overview
The U60 is a portable Diagnostic Ultrasound System, which applies advanced technologies such
as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam),
Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image
parameter adjustments, 15 inch LCD and diverse probes are configured to provide clear and
stable images.
Essential Performance:
Satisfying 2D imaging and basic functions of color ultrasonic system (such as color flow imaging
and spectral Doppler imaging). Please check details as below:
1. Compliant with essential performance requirements of EN60601-2-37.
2. 2D Imaging: It provides B mode and M mode imaging, and complies with requirements of
GB10152-2009.
3. Color flow imaging: It complies with the performance requirements of YY 0767-2009.
4. Spectral Doppler imaging: It complies with the performance requirements of YY 0767-2009.
1.2.Features
Multi-language displays
256 gray scale
Two probe sockets
Display modes:
B, B+B, 4B, B+M, M, B+PW, B+Color, B+Color+PW, B+PDI/DPDI, B+PDI/DPDI +PW.
B+CW, B+Color+CW, B+PDI/DPDI +CW
Generic Measurements and Calculations:
a). B/Color Mode: Distance, Area (Ellipse/Trace), Volume (2-Axis/3-Axis), Ratio, Angle,
and Histogram.
b). M Mode: Distance, Time, Slope and Heart Rate (two cycles).
c). D Mode:
Velocity, Heart Rate, Time, Acceleration, Resistance Index (RI), Pulsatility Index (PI)
and Auto Trace (auto trace is available only for PW mode)

U60 Diagnostic Ultrasound System User Manual Introduction
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1.3.Indications for Use/Intended Use
The diagnostic ultrasound system (U60) is applicable for adults, pregnant women, pediatric
patients’ ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal,
obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal
(conventional and superficial), endovaginal and cardiac clinical applications, by or on the order
of a physician or similarly qualified health care professional.
1.4.Model
U60
1.5.Contraindications
The equipment is not intended for ophthalmic use or any use causing the acoustic beam to
pass through the eye.