EDAN U60 User manual

I

I
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.

II
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

III
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

IV
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

V
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

VI
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

VII
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
- 1 -
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
- 2 -
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.

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 3 -
Chapter 2 Safety Guidance
2.1.Warnings and cautions
In order to use the equipment safely and effectively, and avoid possible dangers caused by
improper operation, please read through the user manual and be sure to be familiar with all
functions of the equipment and proper operation procedures before use. Always keep this manual
with the equipment.
Please pay more attention to the following warning and caution information.
2.1.1.Safety Warnings
NOTE:
The reliability of the device and the safety of operators and patients are considered
during product design and production. The following safety and preventive measures
should be carried out:
WARNING
1. This equipment is not intended for treatment.
2. This equipment is not intended for home use.
3. The diagnosis and examination function of the ultrasonic imaging management
system should be integrated with the clinical situation of patients, and the diagnostic
results are only for the physician’s reference.
4. EXPLOSION HAZARD-Equipment is not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide.
5. The device should be operated by qualified operators or under their instructions.
6. The device should be operated appropriately to avoid mechanical damage to the
transducer.
7. The device is not waterproof. Do not use it in locations where water or any liquid
leakage may occur.
8. Do not use any fluid onto the system surface, as fluid seepage into the electrical
circuitry may cause excessive leakage current or system failure.
9. Do not spray cleaners on the system, as this may force cleaning fluid into the system
and damage electronic components. It is also possible for the solvent fumes to build
up and form flammable gases or damage internal components.

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 4 -
WARNING
10. If the device breaks down, please shut down the machine immediately and contact
EDAN or authorized representatives.
11. Only accessories supplied or recommended by EDAN can be used, the battery and
probes of EDAN can be only used on EDAN’s systems. Otherwise, the performance
and electric shock protection can not be guaranteed. If electrical or mechanical
equipment from other companies need to be connected to the device, please contact
EDAN or authorized representatives before connection.
12. The equipment should be installed by a qualified service engineer. Do not try to
access the interior of the main unit. Only authorized service personnel may remove
the unit cover.
13. To avoid the risk of an electric shock, this equipment must only be connected to
supply mains with protective earth.
14. To ensure grounding reliability, only connect the system to a hospital-grade power
receptacle.
15. To ensure grounding reliability, connect the system only to an equivalent outlet.
16. To avoid electrical shock, inspect whether the grounding wire is connected prior to
powering on the system. And disconnect the grounding wire after powering off the
system.
17. If you have any questions about the grounding connection, use the battery but not
the AC power supply. Prior to using the AC power supply, an inspection of grounding
connection is recommended. If it is necessary, consult EDAN or authorized
representatives for service.
18. Equipment connected to the U60 and located near the patient must be powered from
a medically-isolated power source or must be a medically-isolated device.
Equipment powered from a non-isolated source can cause your system to exceed
leakage current limits. Enclosure leakage current created by an accessory or device
connected to a non-isolated outlet may add to the enclosure leakage current of the
imaging system.
19. When more than one medical device is connected to the patient, the combined
leakage current must comply with IEC/EN 60601-1.
20. SHOCK HAZARD-Do not attempt to connect or disconnect a power cord with wet
hands. Make sure that your hands are clean and dry before touching a power cord.
21. SHOCK HAZARD - Don’t connect non-medical electrical equipment, which has been
supplied as a part of the system, directly to the wall outlet when the non-medical
equipment is intended to be supplied by a multiple portable socket-outlet with an
isolation transformer.

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 5 -
WARNING
22. Use an extension cord or multi-socket outlet setup to provide power to the ultrasound
system or to the system’s peripheral devices, may compromise the system
grounding and cause your system to exceed leakage current limits.
23. Multiple portable socket-outlet is not intended for the device, anybody, who connects
it to the signal input or output connector to configure a medical system, must make
sure that it complies with the requirement specified in Chapter 16 of IEC 60601-1, or
the multi-socket is with an isolation transformer.
24. SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlets supplying the system.
25. If a multiple socket-outlet is necessary, ensure that it is not placed on the floor.
26. Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system.
27. Do not use the additional multiple portable socket-outlet or extension cord in the
medical electrical system, unless it’s specified as part of the system by the
manufacturer. And the multiple portable socket-outlets provided with the system shall
only be used for supplying power to equipment which is intended to form part of the
system.
28. Do not touch accessible parts of electrical equipment and the patient simultaneously.
29. A damaged probe can increase the risk of electric shock if conductive liquids come in
contact with internal live parts. Inspect probes prior to use for cracks, openings, or
other damage that could allow liquid entry.
30. To avoid electrical shock, never modify the ultrasound system’s AC power circuits.
31. To avoid electrical shock and damage to the system, turn off and disconnect the
device from the AC power source before cleaning and disinfecting.
32. Don’t touch the signal input or output connector and the patient simultaneously.
33. To avoid the possibility of electrostatic shock and damage to the system, avoid using
aerosol spray cleaners on the monitor screens.
34. Any non-medical equipment is not allowed to be used within the patient vicinity
(1.5m/6ft.).
35. Periodically have the integrity of the system ground checked by a qualified service
engineer.
36. This device is not suitable for intracardiac use or direct cardiac contact.

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 6 -
WARNING
37. EDAN makes every effort to manufacture safe and effective probes. You must take
all necessary precautions to eliminate the possibility of exposing patients, operators,
or third parties to hazardous or infectious materials. These precautions should be
considered in the use of any application that may indicate the need for such care and
during endocavity scanning.
38. If the liquid crystal material leaks from the panel, it should be kept away from the eye
or mouth. In case of contact with hands, skin or clothes, it has to be washed away
thoroughly with soap.
39. EMI Limitations
Ultrasound machines are susceptible to Electromagnetic Interference (EMI) from
radio frequencies, magnetic fields, and transients in the air of wiring. Ultrasound
machines also generate EMI. The U60 complies with limits as stated on the EMC
label. However, there is no guarantee that interference will not occur in a particular
installation.
Possible EMI sources should be identified before the unit is installed.
Electrical and electronic equipment may produce EMI unintentionally due to one of
the following defects: High frequency electrotome, Transformer, Defibrillator,
Wireless LAN equipment, Medical lasers, Scanners, Cauterizing guns, Computers,
Monitors, Fans, Gel warmers, Microwave ovens, Light dimmers, Portable phones
The presence of a broadcast station or broadcast van may also cause interference.
If you find strong interference shows on the screen, please check the sources.
40. Ultrasound may be harmful to the human body. This device should be used for valid
reasons, for the shortest period of time, and at the lowest mechanical and thermal
indices necessary to produce clinically acceptable images. According to the ALARA
(As Low As Reasonably Achievable) principles, the acoustic output should be set to
the lowest level required to satisfactorily perform the examination. Long time
exposure should be avoided. For the parameters of sound output, please refer to
appendix II. The U60 complies with the requirements of applicable International
Electrotechnical Commission (IEC) standards in terms of safety and acoustic output
levels.
41. Contact with natural rubber latex may lead to a severe anaphylactic reaction in
persons sensitive to the natural latex protein. Sensitive users and patients must
avoid contact with these items. EDAN strongly recommends that health-care
professionals identify their latex-sensitive patients, and refer to the March 29, 1991
Medical Alert on Latex products. Be prepared to treat allergic reactions immediately.

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 7 -
WARNING
42. If a sterile probe cover becomes compromised during an intraoperative application
involving a patient with transmissible spongiform encephalopathy, such as
Creutzfeldt-Jakob disease, follow the guidelines of the U.S. Disease Control Center
and this document from the World Health Organization: WHO/CDS/APH/2000/3,
WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies.
The probes for your system cannot be decontaminated using a heat process.
43. When the device works with the mobile trolley, DO NOT place the device on slopes.
It may suddenly slide, resulting in injury and/or equipment damage.
44. To ensure safety, two people are required to move the device across slopes when
the device works with the mobile trolley.
45. All repairs on products must be performed or approved by EDAN. Unauthorized
repairs will void the warranty. In addition, whether or not covered under warranty, any
product repair shall be exclusively be performed by EDAN certified service
personnel.
46. To ensure optimal imaging, begin the scan session by selecting the correct probe
and application for each examination.
47. The medical electrical equipment needs to be installed and put into service according
to Appendix IV EMC Information.
48. Portable and mobile RF communications equipment can affect medical electrical
equipment. Refer to the recommended separation distances provided in Appendix IV
EMC Information.
49. The use of cables, transducers and accessories not supplied by the manufacturer
may result in increased emissions or decreased immunity of the equipment.
50. The equipment should not be used adjacent to or stacked with other equipment, refer
to the recommended separation distances provided in Appendix IV EMC Information.
51. The system and its accessories shall not be serviced or maintained while in use with
a patient.
52. The mains plug is used to isolate the system from the main power. Position the
system so that it is easy to disconnect the device.
53. Assembly of the system and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
54. This system can not be used together with high-frequency surgical equipment.
55. DO NOT perform any unauthorized modification of the equipment.

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 8 -
NOTE:
The probe stops transmission after freezing, disconnecting, falling off, or entering
sleeping mode. Main control software checks the probe connection all the time, once
probe disconnects from the probe socket, the system stops transmission.
Electromagnetic Compatibility (EMC)
Operating the U60 in close proximity to sources of strong electromagnetic fields, such as
radio transmitter stations or similar installations may lead to interference visible on the
monitor screen. However, the device has been designed and tested to withstand such
interference and will not be permanently damaged.
2.1.2.Battery Safety
To prevent the battery from igniting, emitting fumes, bursting, injuring personal, damaging
equipment, pay attention to the following precautions.
WARNING
1 Improper operation may cause the internal li-ion battery (hereinafter called battery) to
be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It
is necessary to read the user manual carefully and pay more attention to warning
messages.
2 Only qualified service engineers authorized by the manufacturer can open the battery
compartment and replace the battery, and batteries of the same model and
specification should be used.
3 DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
4 Charge the battery only when the ambient temperature is between 0°C and 40°C .
5 When the battery is out of power, please wait for 0.5-1 hours before you charge it, in
order to avoid charging abnormality caused by battery cell overheating.
6 Do not use the battery near heat sources or when the ambient temperature is over
40°C. Do not heat or splash the battery or throw it into fire or water.
7 Do not destroy the battery; do not pierce the battery with a sharp object such as a
needle; do not hit with a hammer, step on or throw or drop to cause strong shock; do
not disassemble or modify the battery. Otherwise, it may be hot, smoking, distorted or
ignited and result in injury.
8 When leakage or foul smell is found, stop using the battery immediately. If your skin
or cloth comes into contact with the leaked liquid, cleanse it with clean water at once.
If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with
clean water first and go to see a doctor immediately.
9 When the battery reaches the end of its service life, or foul smell, deformation,
discoloration, or distortion is found, stop using the battery immediately, replace it with

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 9 -
a new one, and properly dispose of or recycle the depleted battery according to local
regulations.
10 Only when the device is off can the battery be installed or removed.
11 Remove the battery from the device when the device is not used for a long time.
12 Periodic checks on the battery performance are required. Replace the batteries if
necessary.
NOTE:
1. It is recommended to charge the battery after the system is switched off, so that you
can save the charging time.
2. If the battery is stored alone and not used for a long time, we recommend that the
battery should be charged at least once every 6 months to prevent overdischarge.
2.1.3.General Cautions
CAUTION
1. Before use, you must make sure that there is no visible evidence of damage to the
equipment, cables and probes, which may affect patient safety or diagnostic
capability. The recommended inspection interval is once per week or less. If damage
is evident, replacement is recommended before use.
2. If the power cord of the system is missing, damaged or not provided, please
purchase the power cord meeting the specification requirements for the original one
and complying with the local regulations.
3. It is necessary to take the probe out of the probe bracket during moving and
transporting; otherwise, the probe or probe bracket may be broken.
4. The normal ultrasonic examination is recognized as being safe. To avoid burns, do
not scan in the same area for a long period of time. Always minimize the exposure
time while acquiring necessary clinical information
5. To ensure proper grounding and leakage current levels, it is the policy of EDAN to
have an authorized EDAN representative or an EDAN approved third party to
perform all on-board connections of documentation and storage devices to the U60.
6. The device and accessories are to be disposed of according to local regulations
after their useful lives. Alternatively, they can be returned to the dealer or the
manufacturer for recycling or proper disposal. Batteries(including button cell on the
main board) are hazardous waste. Do not dispose them together with house-hold
garbage. At the end of their life hand the batteries over to the applicable collection
points for the recycling of waste batteries. For more detailed information about
recycling of this product or battery, please contact your local Civic Office or the shop
where you purchased the product.
7. Please use the standard power cord as the input line of the network power supply for
the adapter to reduce risk.
8. Federal (U.S.) law restricts this device to sale by or on the order of a physician.

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 10 -
9. To avoid misdiagnosis from inaccurate measurement values, ensure that the target
area of interest and image are correct, and the measurement area is valid.
10. No user serviceable parts are inside the system. All repairs on the system must be
performed by EDAN certified service personnel.
11. The internal storage space of the system is limited. It is highly recommended to back
up patient data and settings regularly.
12. The packaging is to be disposed of according to local or hospital’s regulations;
otherwise, it may cause environmental contamination. Place the packaging at a
location that is inaccessible to children.
13. Properly dispose of used cleaning agents or disinfectants according to your
hospital's regulations.
14. Mind your hand while closing the screen of the system.
15. Any serious incident that has occurred in relation to the device should be reported to
the manufacturer and the competent authority of the Member State in which the user
and/or patient is established.
NOTE:
To avoid damaging the system, DO NOT use it in an environment as below:
1. Locations exposed to direct sunlight.
2. Locations subject to sudden changes in ambient temperature.
3. Dusty locations.
4. Locations subject to vibration.
5. Locations near heat sources.
6. Locations with high humidity.
2.1.4.Network Security Cautions
CAUTION
1. Keep your ultrasound system safe to protect the patient information and data from
being modified, damaged or disclosed caused by unauthorized disassembly.
2. Always ensure the privacy of patient information and data displayed/stored in the
ultrasound system or exported to external storage devices.
3. The software upgrade can only be performed by EDAN-qualified service
professionals with upgrade files of known provenance.
4. Make sure the ultrasound system is used under secure network environment, and all
the approved devices connecting with the ultrasound system are physically secure.
5. Anti-virus measures such as USB device virus scanning should be carried out prior
to using the USB flash drive.
6. Do not connect an USB device with unknown provenance to the ultrasound system.

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 11 -
7. When the ultrasound system is returned for maintenance, disposed of, or removed
from the medical institution for other reasons, ensure all patient data are removed
from the ultrasound system.
8. Hide your password wherever possible when entering it, protecting it from being
disclosed.
2.2.Labeling Symbols
Descriptions of symbols of the device are shown in Table 2-1.
No.
Symbol
Definition
1.
Serial Number
2.
P/N
Part Number
3.
Date of Manufacture
4.
Manufacturer
5.
Operating instructions
6.
Warning
(Background: Yellow; Symbol & outline: Black)
7.
Refer to User Manual
(Background: Blue; Symbol: White)
8.
Caution
9.
Biological Risks
10.
Disposal method. It indicates that the equipment should be sent to special
agencies according to local regulations for separate collection after its
useful life.
11.
General Symbol for Recovery / Recyclable
12.
CE Marking
13.
Authorized Representative in the European Community

U60 Diagnostic Ultrasound System User Manual Safety Guidance
- 12 -
14.
Caution: Federal (U.S.) law restricts this device to sale by or on the order
of a physician.
15.
Type BF Applied Part
16.
Alternating Current (a.c.)
17.
Equipotential grounding
18.
VGA
VGA output, External Monitor
19.
Video Output
20.
Fuse
21.
Transducer for sector-shaped sound field
22.
Computer network
23.
Foot switch
To identify a footswitch or the connection for a foot switch.
24.
Protective earth (ground)
25.
Recording on an information carrier
26.
Trademark
27.
USB (Universal Serial Bus) Connection
28.
Dangerous voltage
29.
Running indicator
30.
Battery check
31.
IPX7
Degree of protection provided by enclosures (IP Code): temporary
immersion. For the probe but not including the probe connector.
32.
Non-sterile. Indicates a medical that has not been subjected to a
sterilization process.