Ultrasound Imaging System

User Manual Rev. 12

Model name: SONON 300C, 300L

Keep this manual with the device for future reference.

Copyrightⓒ All rights reserved by HEALCERION Co., Ltd.

The SONON ultrasound devices are:
• Diagnostic ultrasound equipment which transmits ultrasound waves into the human body and
generate images using the received echoes.
• Categorized as Class II Active Diagnostic Medical Products, according to MDD 93/42/EEC
regulations for use on human patients.
Contact the manufacturer or visit the homepage for detailed information.

Healcerion Co., Ltd. (Manufacturer)

501ho, 11, Gasan digital 2-ro, Geumcheon-gu, Seoul 08593 Republic of Korea
Homepage: www.healcerion.com
Tel: +(82) 2.6347.6328 / E-mail: [email protected]

PROVISION CONSULTING GROUP, INC. (US agent)

13925 CITY CENTER DR. STE 200
CHINO HILLS, CALIFORNIA, 91709, UNITED STATES
Tel: +(1) 909 -4933276 / E-Mail: [email protected]

Obelis S.A. (EC representative)

Bd. Général Wahis 53
1030 Brussels, BELGIUM
Tel: +(32) 2. 732.59.54 / Fax: +(32) 2.732.60.03 / E-Mail: [email protected]

Healcerion EMEA (UK representative)

Future Space UWE(North Entrance) Bristol, BS348RB
Tel: +(44) (0)7484712822 / E-Mail: [email protected]

CAUTION
This device should be used in compliance with all applicable laws.

For USA only:

CAUTION
Federal law restricts this device to use by, or on the orders of, a physician.

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Revision history
Date Revision Description
Released
Oct. 25, 2016 0.0
Typographical errors corrected
Amended:
Jan. 12, 2017 1.0 5.1 Mobile device requirements
9.2 Acoustic output reporting tables
Amended:
2.2 Contraindications
Feb. 22, 2017 2.0 3.1 Symbols
5 Installation of the mobile app
6 Operating the device
Amended:
Aug. 30, 2017 3.0 6 Operating the device
7 DICOM
Amended:
Jan. 15, 2018 3.1
8.3 Cleaning
Amended:
Jan. 15, 2018 3.2
8.3 Cleaning
Amended:
Trademark changed
6 Operating the device
Features added to the HEALCERION app
Apr. 26, 2018 3.3
Auto Gain
Full Screen Mode
Measuring features (angles and volumes)
7 DICOM
Amended:
10.1.4.1 Test methods

Sep. 4, 2018 3.4 10.2 Acoustic output reporting tables

Bilingual safety messages (warnings and cautions)
Moved section 3.7 to section 2.3
Amended:
6.6 Settings
Oct. 10, 2018 3.5
7 DICOM
9.3 DICOM Error

Feb. 1, 2019 4.0 Complete revision / Document integration (SONON 300C/300L)

Added security improvements.
Feb. 10, 2020 5.0
Added snapshot slider function.

Jun. 15, 2020 6.0 Added support for windows platform.

Amended:
Dec. 28, 2020 6.1
Delete Thorax from application

Feb. 24, 2021 7.0 Added model SONON 500L

Amended:
10.2 Guidance and manufacturer’s declarations
Mar. 17, 2021 8.0
10.3 Applicable standards and test methods in accordance with IEC 60601-1-2
Ed. 4

3
 Amended: Correction of typos
3.1 User interface and screen settings
3.2 Selecting operating modes
May 07, 2021 8.1
4.2 Utillizing imaging features
8.1 Inspecting the SONON ultrasound device
9.1 Device-related messages
Amended: 300L label update
1.1 Package contents – ID Label
2.2 Registering user information
10.1 Marking labels
June 04, 2021 8.2
Amended: Addition of note
6.5 Checking activity logs
Note: For users who have registered user information in the server, log
information is recorded in the server.
Amended: Correction of typos: Depth range
4.2 Utilizing imaging features
10.6 Specifications
June 29, 2021 8.3 Amended: NRTL mark on the label of SONON 500L
1.1 Package contents – ID Label
2.2 Registering user information
10.1 Marking labels
Amended: Correction of typos
2 Installing and registering the software

Nov 05, 2021 8.4 3.1 User interface and screen settings
3.2 Selecting operating modes
4.2 Utilizing imaging features

Mar 07, 2022 9 Excluded SONON 500L, Added FDA regulation

Modified manufacturer address, Delete French, Applied FDA requirements
Apr 25, 2022 10
(indications for use, FCC label)
Sep 15, 2022 11 Applied SONON X 4 mode (B, M CF, PW)
Updated 10.4 Acoustic output
April 6, 2023 12
Changed in U.S. Agent

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 Table of contents

Table of contents
Table of contents ........................................................................................................................................ 5
About this user manual ........................................................................................................................... 11
Intended audience ............................................................................................................................................. 12
Document conventions .................................................................................................................................... 13
Safety messages used in this manual ...........................................................................................................13
Symbols used in this manual .............................................................................................................................14
Safety information .................................................................................................................................... 16
General safety ..................................................................................................................................................... 16
Electrical safety ................................................................................................................................................... 17
Battery-related safety information ....................................................................................................................17
Immersion level ........................................................................................................................................................18
Coupling gels ....................................................................................................................................................... 18
Application ..................................................................................................................................................................18
Precautions ................................................................................................................................................................18
Approved coupling gels ........................................................................................................................................19
Bioeffects and safety of ultrasound scans ............................................................................................... 20
Thermal safety ..........................................................................................................................................................20
Prudent use................................................................................................................................................................20
Bioeffects ....................................................................................................................................................................21
Other considerations......................................................................................................................................... 22
Operating temperature ..........................................................................................................................................22
Operating and storage conditions ....................................................................................................................22
Image display quality .............................................................................................................................................22
Disposal of the device ...........................................................................................................................................22
Battery disposal........................................................................................................................................................23
1 Device overview ................................................................................................................................ 24
Intended use ........................................................................................................................................................ 24
Indications for use ...................................................................................................................................................24
Contraindications .....................................................................................................................................................25
Intended patient profile .................................................................................................................................... 25
Principles of operation ..................................................................................................................................... 25
1.1 Package contents ..................................................................................................................................................... 27
Part names............................................................................................................................................................ 28
SONON 300C ...........................................................................................................................................................28
300L ..............................................................................................................................................................................29
1.2 Charging and replacing battery .......................................................................................................................... 30
Battery-related safety information ............................................................................................................... 30
Charging battery with battery charger ....................................................................................................... 31
Battery charger indications during charging ................................................................................................31
Directly charging device .................................................................................................................................. 32

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Power LED indications during a charge ........................................................................................................32

Installing and removing battery .................................................................................................................... 33
Installing the battery ...............................................................................................................................................33
Removing the battery ............................................................................................................................................33
1.3 Turning on or off the device ................................................................................................................................. 34
Turning on the device ....................................................................................................................................... 34
Turning off the device ....................................................................................................................................... 34
2 Installing and registering the software ......................................................................................... 35
Touchscreen gestures ..................................................................................................................................... 35
System requirements for mobile devices ................................................................................................. 36
Operating system versions .................................................................................................................................36
Minimum specifications for mobile devices .................................................................................................36
2.1 Installing the HEALCERION app (SONON X ultrasound app) .............................................................. 37
For Apple (iOS) smart devices ..................................................................................................................... 37
For Android smart devices ............................................................................................................................. 37
For Universal Windows Platform (UWP) smart devices .................................................................... 37
2.2 Registering user information ................................................................................................................................ 38
How to register user information in the app storage ........................................................................... 38
How to register user information through the server ........................................................................... 39
2.3 Starting an exam for the first time ...................................................................................................................... 40
Connecting the device with Wi-Fi ................................................................................................................ 40
Starting a scan .................................................................................................................................................... 41
Quick scan in QUICK SCAN mode ............................................................................................................ 43
3 User interface and scan modes ..................................................................................................... 44
3.1 User interface and screen settings.................................................................................................................... 44
Scan screen interfaces .................................................................................................................................... 44
Menu area interfaces ........................................................................................................................................ 46
Configuring screen parameters .................................................................................................................... 48
Device orientation .............................................................................................................................................. 51
3.2 Selecting operating modes ................................................................................................................................... 52
B mode operation (brightness mode, or 2D mode) ............................................................................. 52
B mode specific settings ......................................................................................................................................53
CF mode operation (color flow mode) ....................................................................................................... 53
CF mode specific settings ...................................................................................................................................54
PW mode operation (pulsed wave mode) ............................................................................................... 54
PW mode specific settings ..................................................................................................................................55
M mode operation (motion mode) ............................................................................................................... 56
M mode specific settings......................................................................................................................................56
4 Utilizing scan screen features ........................................................................................................ 57
Unfreeze/Freeze mode screens .................................................................................................................. 57

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4.1 Utilizing presets ......................................................................................................................................................... 57

Presets for the SONON 300C ...........................................................................................................................57
Presets for the 300L ...............................................................................................................................................57
Selecting a preset .............................................................................................................................................. 58
Saving a preset after making parameter changes ............................................................................... 58
Saving changes to an existing preset ............................................................................................................59
Creating a new preset after making changes .............................................................................................60
4.2 Utilizing imaging features ...................................................................................................................................... 61
Zooming in and zooming out ......................................................................................................................... 61
Adjusting scan focus (FL: Focal Length) .................................................................................................. 61
Adjusting scan depth (Depth)........................................................................................................................ 62
4.3 Recording and reviewing exams ........................................................................................................................ 63
Recording exam videos ................................................................................................................................... 63
Capturing images ............................................................................................................................................... 63
Playing back recorded exams with Quick Viewer ................................................................................ 64
Playing back recorded exams with Snapshot Slider ........................................................................... 65
Reviewing exams in Dual screen ................................................................................................................ 66
Starting Dual screen mode .................................................................................................................................66
Utilizing Dual screen mode ............................................................................................................................ 67
Live freeze + Live scan .........................................................................................................................................67
Live freeze + Review .............................................................................................................................................67
Review + Live scan ................................................................................................................................................68
Review + Review .....................................................................................................................................................69
4.4 Measuring on-screen objects .............................................................................................................................. 70
Starting Freeze mode ............................................................................................................................................70
Measuring lengths ............................................................................................................................................. 71
Measuring angles ............................................................................................................................................... 72
Measuring circumferences and areas ....................................................................................................... 73
Measuring volumes ........................................................................................................................................... 74
Leaving comments ............................................................................................................................................ 76
Assessing fetal biometry ................................................................................................................................. 77
Deleting measurements .................................................................................................................................. 79
Deleting an individual measurement ..............................................................................................................79
Deleting all measurements .................................................................................................................................79
5 Managing patient data ..................................................................................................................... 80
5.1 Handling patient information ................................................................................................................................ 80
Registering a patient ......................................................................................................................................... 80
Deleting patient entries .................................................................................................................................... 81
Editing patient information .............................................................................................................................. 82
Merging patient information ........................................................................................................................... 83

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5.2 Reviewing and handling exam records ........................................................................................................... 84

Playing recorded videos .................................................................................................................................. 84
Zooming in and out on the video ......................................................................................................................85
Measuring objects in a video .............................................................................................................................85
Playing back captured images...................................................................................................................... 87
Zooming in and zooming out on an image ...................................................................................................87
Measuring objects ...................................................................................................................................................88
Reviewing exam records in Dual screen .................................................................................................. 90
Utilizing Dual screen mode ............................................................................................................................ 91
Review + Live scan ................................................................................................................................................91
Review + Review .....................................................................................................................................................91
Sharing, uploading, or deleting recorded exams .................................................................................. 92
6 Settings .............................................................................................................................................. 96
6.1 Device settings .......................................................................................................................................................... 96
Changing Wi-Fi password .............................................................................................................................. 96
Factory Mode Reset .......................................................................................................................................... 97
Checking device firmware version .............................................................................................................. 97
6.2 Setting preferences .................................................................................................................................................. 98
6.3 Changing login password ...................................................................................................................................... 99
Changing login password (When user information is stored in app storage) ........................... 99
Changing login password (When user information is stored on the server) ........................... 101
Finding a forgotten password (When user information is stored in app storage) ................. 102
Finding a forgotten password (When user information is stored on the server) ................... 103
6.4 Managing verified AP list ..................................................................................................................................... 104
6.5 Checking activity logs ........................................................................................................................................... 104
6.6 Managing preset ..................................................................................................................................................... 105
Initializing Presets ............................................................................................................................................ 105
Deleting presets ................................................................................................................................................ 106
Exporting presets ............................................................................................................................................. 107
Importing presets ............................................................................................................................................. 108
6.7 Backing up patient data ....................................................................................................................................... 109
6.8 Importing backup files ........................................................................................................................................... 110
6.9 Changing Wi-Fi settings ....................................................................................................................................... 111
Changing Wi-Fi settings on Android mobile devices ........................................................................ 111
Changing Wi-Fi settings on iOS mobile devices ................................................................................. 112
7 DICOM settings ............................................................................................................................... 113
7.1 Configuring DICOM settings .............................................................................................................................. 113
7.2 Configuring DICOM TLS settings .................................................................................................................... 114
7.3 DICOM workflow ..................................................................................................................................................... 115
DICOM workflow for Android mobile devices ....................................................................................... 115

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DICOM workflow for iOS mobile devices ............................................................................................... 116

DICOM workflow for UWP mobile devices ............................................................................................ 117
7.4 Turning off the device ........................................................................................................................................... 117
8 Maintenance .................................................................................................................................... 118
8.1 Inspecting the SONON ultrasound device ................................................................................................... 118
8.2 Cleaning the SONON ultrasound device ...................................................................................................... 119
Approved cleaning products ........................................................................................................................ 119
9 Troubleshooting ............................................................................................................................. 120
9.1 Device-related messages.................................................................................................................................... 120
9.2 Device connection-related messages ............................................................................................................ 121
9.3 DICOM network-related messages ................................................................................................................. 121
9.4 Reporting security issues .................................................................................................................................... 122
9.5 Security note ............................................................................................................................................................. 123
10 Technical information .................................................................................................................... 124
Safety conformance ........................................................................................................................................ 124
Essential performance ................................................................................................................................... 124
10.1 Marking labels .................................................................................................................................................... 124
Marking labels on the device....................................................................................................................... 124
ID label ...................................................................................................................................................................... 125
Side label ................................................................................................................................................................. 125
Marking labels on power supply accessories ....................................................................................... 126
AC adapter .............................................................................................................................................................. 126
Battery charger ...................................................................................................................................................... 126
10.2 Guidance and manufacturer’s declarations ........................................................................................... 127
Electromagnetic emissions .......................................................................................................................... 127
Electromagnetic immunity ............................................................................................................................ 128
Separation from other RF wireless communications equipment ................................................. 130
10.3 Applicable standards and test methods in accordance with IEC 60601-1-2 Ed. 4 ............... 131
10.4 Acoustic output .................................................................................................................................................. 132
Acoustic output parameters ......................................................................................................................... 132
Thermal Index (TI) ............................................................................................................................................... 132
Mechanical Index (MI) ........................................................................................................................................ 132
Ispta ............................................................................................................................................................................... 132
Acoustic output reporting tables for SONON 300C ........................................................................... 133
B(M) mode (IEC 60601-2-37) ......................................................................................................................... 133
B-mode (Track 3 for FDA) ................................................................................................................................ 133
CF mode (PW mode) (IEC 60601-2-37) .................................................................................................... 134
B-mode (with M mode) (FDA) ......................................................................................................................... 135
CF-mode (PW mode) (FDA)............................................................................................................................ 136
Acoustic output reporting tables for 300L .............................................................................................. 137

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B(M) mode (IEC 60601-2-37) ......................................................................................................................... 137

CF(PW) mode (IEC 60601-2-37) .................................................................................................................. 138
B-mode (FDA) ........................................................................................................................................................ 139
CF-mode (FDA)..................................................................................................................................................... 140
10.5 Acoustic output and display accuracy ..................................................................................................... 141
Display accuracy and acoustic measurement uncertainty ............................................................. 141
Display accuracy .................................................................................................................................................. 141
Measurement accuracy ..................................................................................................................................... 141
System controls affecting acoustic output ............................................................................................. 142
Choosing an appropriate clinical application ........................................................................................ 142
10.6 Specifications ..................................................................................................................................................... 143
Model name: SONON 300C ........................................................................................................................ 143
Model name: 300L ........................................................................................................................................... 143
Battery (rechargeable Li-ion battery pack) ............................................................................................ 144
Glossary - Abbreviations ................................................................................................................. 145

Appendix A Usage Agreement ..................................................................................................... 147

Appendix B Medical Ultrasound Safety .................................................................................... 151

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About this user manual

This manual is intended to assist you with the safe operation of your SONON ultrasound device. Read
this manual thoroughly before operating the product and observe all safety instructions.

HEALCERION has prepared this manual carefully in order to ensure that the information it contains is
accurate. However, HEALCERION will not be liable for any possible errors or omissions of information
in this manual.

HEALCERION reserves the right to make changes to the products or the associated software apps
described in this manual without further notice, to improve product reliability, function, or design.

This document is protected under copyright law. Reproduction or modification of this manual without
prior approval by HEALCERION is strictly prohibited.

NOTE
• All references to standards and regulations and their revisions are valid as of the date of publication
of this user manual.
• Some optional parts or functions described in this user manual may not be available in some
countries. For information specific to your region, contact your local representative.
• The screenshots and illustrations in this manual are for illustrative purposes only. They may differ
from the actual images on the display.

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Table of contents

Intended audience
This user manual is intended for healthcare professionals who operate and maintain the SONON
ultrasound device. The user must be properly trained in sonography and familiar with ultrasound
techniques and clinical procedures. See the flowing table for the profile of intended users of the
SONON ultrasound device.

Trained professionals who have completed related coursework, such as

Training
doctors, nurses, emergency medical technicians, and medical students
Qualifications:
• Basic knowledge of sonography
• Understanding of the physiological effects of ultrasound exposure
• Ability to recognize, understand, operate, and update the mobile device
Knowledge level that is linked to the SONON ultrasound device
• Intuitive understanding of the software and hardware user interface and
ability to update the software app
• Understanding of the terms in the user manual, which are necessary for
the operation of the device

Understanding of the instructions and procedures provided in this

Linguistic capability
manual

Experience Experience in the field of sonography

Vision Corrected visual acuity of 1.0 or better

Ability to read through this user manual and remember the safety
Memory
instructions and functions of the device

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 Table of contents

Document conventions
Safety messages used in this manual
The following safety messages are provided in this user manual to warn users against potentially
hazardous situations that may result in death, injury, or property damage.

WARNING
Provides important information required for the safety of the operator and the patient.

CAUTION
Provides information required to avoid damaging the device or losing patient data.

NOTE
Provides useful information that will help you operate the product more efficiently.

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Table of contents

Symbols used in this manual

The following table lists symbols for use with electrical medical equipment, which are agreed upon as
the international standard by the IEC. These symbols are used to provide information about safety, as
well as additional information about the product and the use of the product.
Symbol Definition
Electrical protection: Insulated patient application (Type BF)

Warning: This symbol indicates hazards related to operating conditions.

Consult accompanying documents: This symbol advises the reader to consult the
accompanying documents.
Freeze mode: This symbol is used for the Freeze button on the device, which is
used to freeze the scan screen.
Stand-by: This symbol is used for the power button on the device, which is used to
turn the device on or off or to put the device in standby mode.
Wi-Fi: This symbol indicates wireless communication.
Manufacturer information: This symbol is followed by the name and address of the
device manufacturer.
Manufacture date: This symbol is followed by the device manufacture date in the
form YYYY-MM.
Serial number: This symbol is followed by the device serial number.

Model name: This symbol is followed by the model name of the product.
Representative information: This symbol is followed by the information about
manufacturer’s EU representative.
This way up: This symbol indicates the correct upright position of the transport
package.

Fragile; handle with care

Keep dry

Indicates the need for separate collection of electrical and electronic equipment in
compliance with the Waste Electrical and Electronic Equipment (WEEE) Directive.
For more information, see “Disposal of the device” on page.
USA federal law restricts this device to sale by or on the order of a physician.

RF Equipment for non-ionizing radiation

Temperature limitation

Humidity limitation

Atmospheric pressure limitation

MR Unsafe
An item which poses unacceptable risks to the patient, medical staff, or other
persons within the MR environment.

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 Table of contents

This device is provided non-sterile.

Module: SWM-500, FCC ID: XPYEMMYW161

15
Safety information

Safety information
Before you start operating your device you must thoroughly read and understand the safety
information in this section and follow it strictly while operating the device.

General safety
The following safety instructions are intended to provide guidelines for using the SONON ultrasound
device.

WARNING
• Do not use a damaged or defective device. Failure to follow can result in serious injury and
equipment damage.

• In case of device failure, ensure that the device is repaired only by an authorized technician.

• If the device has been dropped on the floor or on any other hard surface, refrain from using the
device. Using a dropped device may increase the risk of electric shock due to damaged electrical
insulation.

• Do not attempt to open the device. The warranty may be voided if such an attempt is detected.

• The device is not delivered sterile. Before the first use, you must clean the device to avoid infection or
disease transmission.

• The device must be cleaned before it is replaced or disposed of.

• Inspect the device prior to each use for damage to or degeneration of the housing, strain relief, lens,
or seal. A thorough inspection should be conducted during the cleaning process.

• Do not modify this device without prior authorization by HEALCERION.

• Do not use the device with high-frequency surgical equipment. Doing so may damage the equipment.

• Do not touch the patient while using a mobile device.

• Do not touch the patient and the charging connectors simultaneously.

• Operate this device prudently in compliance with the ALARA (as low as reasonably achievable)
principle. It is strongly recommended that you consider ALARA whenever you conduct ultrasound
scans. See “Bioeffects and safety of ultrasound scans” on page for additional information.

• Features that facilitate observation and measurement of ultrasound images must be configured with
extreme care. Some default configurations are recommended by the device. If in doubt, verify the
images by comparing them with manual measurements. Diagnostic interpretations of measurements
shall be carried out at your discretion.

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 Safety information

CAUTION
• This device should be used in compliance with applicable laws. Some jurisdictions restrict certain
uses, such as gender determination.

• Allow the device to rest for 10 minutes after 10 minutes of scanning.

• Data stored in a mobile device cannot be recovered if you lose your mobile device.

• Changing the display settings can affect image quality and compromise diagnostic accuracy. It is
your responsibility to adjust the display settings appropriately to obtain desirable image quality.

• Because this device is composed of highly sensitive electronic components, it can be easily damaged
by improper handling. Use carefully when handling this device and protect the device from damage
when not in use.

• Using unapproved coupling gels or inappropriate cleaning agents may result in transducer damage.

• Do not soak or saturate the transducer (device head) with solutions containing alcohol, bleach,
ammonium chloride compounds, hydrogen peroxide, or any incompatible solutions.

Electrical safety
The device is operated using electrical energy that can harm patients or users if live internal parts
come into contact with conductive solutions.

WARNING
• Do not immerse the device in any liquid beyond the immersion level. Never immerse the device
connector in any liquid.

• Do not drop the device or subject it to other types of mechanical shock or impact. Degraded
performance or damage such as cracks or chips in the housing may result.

• Electrical leakage checks should be performed on a routine basis by qualified hospital personnel.

Battery-related safety information

CAUTION
• Do not disassemble or puncture the battery, or expose the battery to excessive impact.
• Do not place the battery near a heat source or expose it to open flame. Such exposure may lead to
leakage of corrosive liquid, electric shock, or fire.
• If any liquid from the battery should come into contact with the eye, immediately wash the eye with
plenty of water and seek medical assistance as soon as possible.
• Do not immerse the battery or expose the battery to water.
• The AC adapter must be kept outside the patient environment (refer to IEC 60601-1).

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Safety information

Immersion level

CAUTION
The SONON ultrasound device satisfies IPX7 requirements for being watertight up to a maximum of
1.57 in. (4 cm) from the head (transducer side). Do not immerge the device in any liquid over the
maximum immersion level.

Electromagnetic compatibility
• The SONON ultrasound device has been tested and found to comply with IEC 60601-1-2
electromagnetic compatibility (EMC) limits.
• This device is intended for use in the electromagnetic environment specified in “10.2
Guidance and manufacturer’s declarations” on page of this manual.

CAUTION
SONON Ultrasound system is not intended for using in MR environment.
It poses unacceptable risks to the patient, medical staff, or other persons within the MR environment.

Coupling gels
CAUTION
Do not use non-approved gels (lubricants). They may damage the device and void the warranty.

Application
In order to ensure transmission of energy between the patient and the SONON ultrasound device, a
conductive gel or couplant must be applied liberally to the area of the patient’s body where scanning
will be performed.

Precautions
Coupling gels should NOT contain any of the following ingredients, as they are known to cause
damage to the ultrasound scanning device.
• Methanol, ethanol, isopropanol alcohol, or
any other alcohol-based products • Aloe vera

• Mineral oils • Olive oil

• Iodine • Methyl or ethyl parabens (para

hydroxybenzoic acid)
• Lotions
• Dimethylsilicone
• Lanolin

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 Safety information

Approved coupling gels

The coupling gels approved by the manufacturer are as follows.
Product name Manufacturer
Aquasonics 100 Parker Laboratory Inc.
Clear Image Sonotech Inc.

Scan Parker Laboratory Inc.

Sonogel Sonogel Vertriebs

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Safety information

Bioeffects and safety of ultrasound scans

Thermal safety
Maintaining a safe thermal environment for the patient has always been a design priority at
HEALCERION. When contacting the ultrasound device on the skin, the maximum allowed

temperature must remain below 109.4℉ (43 °C).

Whenever ultrasound waves travel through tissues, there is always a certain risk of damage. There
has been a great deal of research on the impact that high-frequency waves can have on different
kinds of tissues under defined conditions, and “there is, to date, no evidence that diagnostic
ultrasound has produced any harm to humans – including the developing fetus” (Guidelines for the
Safe Use of Diagnostic Ultrasound Equipment, Safety Group of the British Medical Ultrasound Society
2010).
In contrast to the results of exposure to ionizing radiation, the physiological effects of exposure to
ultrasound are generally assumed to be deterministic and only occur above a certain threshold, where
the effects are only accidental. Ultrasound examinations can be conducted very safely if certain
procedures are followed. Therefore, it is recommended that operators read the following sections and
study the cited literature.

Prudent use
Despite the relatively low risk of ultrasound scans, as compared to other imaging techniques, the
operator must choose exposure levels with caution to minimize the risks of bio-effects.
“A fundamental approach to the safe use of diagnostic ultrasound is to use the lowest output power
and the shortest scan time consistent with acquiring the required diagnostic information. This is the
ALARA (as low as reasonably achievable) principle. It is acknowledged that in some situations it is
reasonable to use higher output or longer examination times than in others: for example, the risk of
missing a fetal anomaly must be weighed against the risk of harm from potential bio-effects.
Consequently, it is essential for operators of ultrasound scanners to be properly trained and fully
informed when making decisions of this nature” (Guidelines for the Safe Use of Diagnostic Ultrasound
Equipment, Safety Group of the British Medical Ultrasound Society 2010).
Special care regarding ALARA should be taken with obstetric examinations, as any potential bio-
effects are likely to be of greatest significance in the embryo or fetus.
It is strongly recommended that operators consider ALARA when conducting ultrasound scans (See
“Appendix B Medical Ultrasound Safety”).

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 Safety information

SONON ultrasound devices provide the following frequency outputs and operating modes:
Model name Frequency Operating mode Reference
SONON 300C 3.5 MHz B, CF, PW, M modes
Low ultrasonic powered
300L 5MHz/7.5MHz/10MHz B, CF, PW, M modes
When using the SONON ultrasound device you can control the following factors (TI/MI output value is
less than 1).
• TGC (Time Gain Compensation)
• DR (Dynamic Range)
• FL (Focal Length)
• Depth
• Image filters
The SONON ultrasound device is safe to use in B, CF, PW and M modes, because the ultrasound
waves applied to the human body are dispersed rather than concentrated at one point.

To further ensure safe operation of the SONON ultrasound device, HEALCERION provides an
educational publication by the American Institute of Ultrasound in Medicine, Medical Ultrasound
Safety (AIUM 2014), as an appendix to this document.

These educational materials are provided to prevent the improper use or abuse of the SONON
ultrasound device.

Bioeffects
Thermal effects related to the heating of soft tissue and bone
The thermal indices “TIs” (for soft tissue), “TIb” (for bone near the focus), and “TIc” (for bone near the
surface) were introduced to provide the operator with relative potentials of tissue temperature rise.
The Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment (2004) stipulates that these thermal indices shall be displayed by ultrasound
consoles. It should be noted that a TI of 1 does not necessarily mean that tissues being scanned will
increase in temperature by 33.8℉(1˚C). Almost every scanning situation departs from the assumed
model conditions, such as tissue types, blood perfusions, mode of operation and actual exposure time
of the scanned area. However, by suggesting information regarding possible increase in risk from
potential thermal bioeffects, thermal indices provide a relative magnitude that can be used to
implement ALARA. In addition to tissue heating due to the generated ultrasound field, the temperature
of the probe head itself can also increase during the examination. The operator should be aware that
superposition of heat may result at the tissue regions near the ultrasonic transducer due to the
ultrasound field, which is not considered in the TI values.

Non-thermal effects related to mechanical phenomena such as cavitation

Non-thermal bio-effects are caused by the interaction of ultrasound fields with very small pockets of
gas (stabilized gas bodies), i.e., the generation, growth, vibration and possible collapse of
microbubbles within the tissue. This behavior is referred to as cavitation (Medical Ultrasound Safety,
2nd Edition, AIUM 2009 / American Institute of Ultrasound in Medicine Consensus Report on Potential
Bio-effects of Diagnostic Ultrasound, AIUM 2008 / Guidelines for the safe use of diagnostic ultrasound
equipment, Safety Group of the British Medical Ultrasound Society 2010). The potential of cavitation
increases with rarefactional peak pressure and decreases with pulse frequency. For these reasons,
the “MI (Mechanical Index)” was introduced to take account of both pressure and frequency. Higher
MI indicates greater risk of non-thermal bio-effects.

21
Safety information

Other considerations
Operating temperature
Like most high-frequency computing devices, the electronic components of the SONON ultrasound
device generate heat during normal operation. The device is equipped with safety mechanisms to
automatically reduce computing speed (frame rate) and ultimately shut down the device before any
risk of overheating occurs. The device has been verified to comply with harmonized safety standards
under all operating conditions described in this manual.

NOTE
When you hold the SONON ultrasound device for operation, be careful not to block the air vent. The air
vent keeps the device operating at an optimal temperature and ensures longer scanning times with the
maximum frame rate.

Operating and storage conditions

Refer to the following table for the operating, storage, and transportation conditions of the SONON
ultrasound device.
Operating conditions Storage/Transportation conditions

Temperature +64.4°F to +86℉ (+18℃ to +35℃) +14°F to +122°F (-10℃ to +50℃)

Humidity 30% to 75% noncondensing 10% to 85% noncondensing

Pressure 700hPa (3000m) to 1060hPa 700hPa (3000m) to 1060hPa

Image display quality

The image display quality of your mobile device may vary depending on ambient light conditions.
Avoid direct sunlight on the display when scanning and reviewing images.

Disposal of the device

This symbol indicates that electrical and electronic equipment waste must not be
disposed of as unsorted municipal waste, and must be collected separately.
Please contact the manufacturer or an authorized disposal company to decommission
your equipment according to local regulations.

22
 Safety information

Battery disposal
CAUTION
Lithium batteries are included with this device. Do not puncture, mutilate or dispose of batteries in
fire. Replace only with batteries of the same type, as recommended by the manufacturer. Dispose
of used batteries in accordance with the manufacturer’s instructions and in accordance with your
local regulations.

This separate collection symbol is affixed to a battery, or its packaging, to advise you
that it must be recycled or disposed of in accordance with local and national laws. To
minimize potential impact to the environment and human health, it is important that all
marked batteries removed from the product be properly recycled or disposed of. For
information on how batteries can be safely removed from the device, please consult the
equipment instructions or your local authorities.

23
Device overview

1 Device overview
Intended use
The SONON ultrasound device is a portable ultrasound scanner intended for use in professional
healthcare environments, to obtain ultrasound echo images that can be used for clinical diagnostic
purposes.

CAUTION
Appropriate data safety measures must be taken for patient data because the SONON ultrasound device
stores diagnostic data on a personal mobile device. It is your responsibility to keep patient data safe and
secure.

The SONON ultrasound device must be used only for the purposes for which the device was
designed. The device is intended to be handled and operated in accordance with all the safety
procedures and operating instructions in this user manual.

Indications for use

The SONON ultrasound device is indicated for ultrasound echo imaging, measurement, and analysis
of the human body for general clinical applications. Indications for use by model are as follows.
Model name Applications
• Obstetrics (OB)
SONON 300C • Gynecology (GY)
• General (abdominal)
• Musculoskeletal (MSK)
300L • Vascular
• Small parts (breast, thyroid)

SONON 300C
Jurisdiction Applications
The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for
diagnostic ultrasound echo imaging, measurement, and analysis of the human body for
general clinical applications including obstetrics (OB), gynecology (GY) and general
FDA (abdominal) imaging. The system operating modes is B (Brightness), CF (color flow),
PW (pulsed wave), M (motion). The intended to be used in a hospital or medical clinic is
used by appropriately trained healthcare professionals, including radiologists,
sonographers, technologists, and clinicians, in a medical facility.
The SONON 300C is indicated for ultrasound echo imaging, measurement, and
analysis of the human body for general clinical applications including obstetrics (OB),
CE gynecology (GY) and general(abdominal) imaging. Its user interface and portability
enable it for use in primary care and special care areas, such as medical office
settings, clinics and emergency room in hospitals

다양한 장소로의 이동이 용이하도록 밴, 트레일러 등의 차량에 부착하여 사용하는 초음파

MFDS
영상 진단 장치

24
 Device overview

300L
Jurisdiction Applications
The SONON Ultrasound Imaging System (Model: 300L) is intended for diagnostic
ultrasound echo imaging, measurement, and analysis of the human body for general
FDA
clinical applications including Musculoskeletal (MSK) Vascular Small parts (breast,
thyroid) imaging.
The ultrasound device is a portable ultrasound scanner intended for use in professional
healthcare environments, to obtain ultrasound echo images that can be used for clinical
diagnostic purposes.
CE
The device is indicated for ultrasound echo imaging, measurement, and analysis of the
human body for general clinical applications including musculoskeletal (MSK), vascular,
small parts (breast, thyroid).
다양한 장소로의 이동이 용이하도록 밴, 트레일러 등의 차량에 부착하여 사용하는 초음파
MFDS
영상 진단 장치


Contraindications
WARNING
The SONON ultrasound device is not intended for ophthalmic use or any use causing the acoustic
beam to pass through the eye.

Intended patient profile

See the following table for the intended patient profile for the SONON ultrasound device.
Age Any
Weight Any
Stable condition. Do not use this device to examine patients who may be
Health condition harmed by exposure to ultrasound (e.g., patients with implanted pace-
makers).
Use conditions To be used by trained professionals only. Not to be used by patients.

Principles of operation
The SONON ultrasound device utilizes pulsed-echo technology to determine the depth and location of
tissue interfaces.

Ultrasound imaging requires mechanical oscillation of crystals excited by electrical pulses, generating
a piezoelectric effect. A number of these crystals make up a transducer, which converts one type of
energy into another. Using pulse-echo transformation by the piezoelectric crystals, an ultrasound
transducer converts electricity into sound.

25
Device overview

- SONON 300C, 300L

The SONON ultrasound device measures the duration of an acoustic pulse travelling from the
transmitter to the tissue interface and back to the receiver. Ultrasound waves emitted from the
transducer propagate through various tissues and return to the transducer as reflected echoes.
These echoes are then converted into high-frequency electrical signals by the crystals in the
transducer. Next, the signals are amplified and further processed by several analog and digital circuits
and software filters to adjust the frequency and time response, in order to finally generate a series of
digital images.

26
 Device overview

1.1 Package contents

When you open the package, you will find the following items. Make sure that you have all of the
items before using the device.
[SONON 300C, 300L]

SONON ultrasound device* Batteries (2EA)

Power adapter / power cable Power adapter / power cable

(for battery charger) (micro USB for device)

Battery charger Quick start guide

*Check the ID label and ensure that the device name and model name are correct.

27
Device overview

Part names
SONON 300C

NOTE
For safety reasons, the device automatically turns off when directly charged with the micro USB
connector.

Transducer head is the contact to human skin with couplant.

Refer to the following table for buttons and operation status indicators.
Buttons/Indicators Description
Press and hold power button for about 2 seconds to turn device on or
Power button
off.
When device is on: white
Power LED When device is turned off: green (2 sec), then off
While charging (micro USB): green
Press the Freeze button to switch between Freeze and Unfreeze
Freeze button
modes.
(operation mode LED)
(Freeze mode: flashing blue / Unfreeze mode: blue)
Press and hold to turn the Wi-Fi function of the device on or off.
Device is ready: green
Wi-Fi is on: blue (2.4 GHz) / green (5 GHz)
Wi-Fi button
(You can Press and hold the Wi-Fi button for about 5 seconds to
switch between the frequencies.)
Wi-Fi is off: off

28
 Device overview

300L

NOTE
For safety reasons, the device automatically turns off when directly charged with the micro USB
connector.

Transducer head is the contact to human skin with couplant.

Refer to the following table for buttons and operation status indicators.
Buttons/Indicators Description
Press and hold power button for about 2 seconds to turn device on or
Power button
off.
When device is on: white
Power LED When device is turned off: green (2 sec), then off
While charging (micro USB): green
Press the Freeze button to switch between Freeze and Unfreeze
Freeze button
modes.
(operation mode LED)
(Freeze mode: flashing blue / Unfreeze mode: blue)
Press and hold to turn the Wi-Fi function of the device on or off.
Device is ready: green
Wi-Fi is on: blue (2.4 GHz) / green (5 GHz)
Wi-Fi button
(You can Press and hold the Wi-Fi button for about 5 seconds to
switch between the frequencies.)
Wi-Fi is off: off

29
Device overview

1.2 Charging and replacing battery

Your SONON ultrasound device is powered by a lithium-ion (Li-ion) battery. The battery is not fully
charged prior to shipment. To maximize battery life, it is recommended that you fully charge the
battery before initial use.

Battery-related safety information

CAUTION
• Do not disassemble or puncture the battery, or expose the battery to excessive impact.
• Do not place the battery near a heat source or expose it to open flame. Such exposure may lead to
leakage of corrosive liquid, electric shock, or fire.
• If any liquid from the battery should come into contact with the eye, immediately wash the eye with
plenty of water and seek medical assistance as soon as possible.
• Do not immerse the battery or expose the battery to water.
• The AC adapter must be kept outside the patient environment
(refer to IEC 60601-1).

[Patient environment]

NOTE
If you travel by plane, pack your spare batteries in a carry-on bag whenever possible. In many countries
including the USA, shipping spare Li-ion batteries (uninstalled) in checked bags is not allowed.

You can charge the internal battery of the SONON ultrasound device either by using the battery
charger or by connecting the USB cable to the charging connector on the SONON ultrasound device.

30
 Device overview

Charging battery with battery charger

Connect the power cable to the AC adapter (A), connect the AC adapter to the battery charger (B),
plug the power cable into the wall outlet (C), then attach the battery to the battery charger (D).

CAUTION
Use only the battery charger and AC adapter packaged with the device.

Battery charger indications during charging

LED status Description
Green Fully charged, or not charging / battery is not attached
Red Charging

31
Device overview

Directly charging device

Connect the power cable to the AC adapter (A), plug the power cable into the wall outlet (B), then
plug the micro USB connector into the SONON ultrasound device (C).

NOTE
For safety reasons, the device automatically turns off when directly charged with the micro USB
connector.

Power LED indications during a charge

Power LED status Description
Flashing green Charging error / not charging
Steady green Charging
OFF Fully charged
White Low battery

32
 Device overview

Installing and removing battery

Refer to the following instructions to install and replace a battery.

Installing the battery

1 Slide and hold down the lock lever (A), then slide the battery cover in the direction indicated by
the arrow (B).

2 Lift the battery cover (C) and insert a charged battery into the battery chamber (D).

3 Close the battery cover and slide the battery cover in the direction indicated by the arrow until the
cover locks into position (E).

Removing the battery

1 Slide and hold down the lock lever (A) and slide the battery cover in the direction indicated by the
arrow (B).

2 Lift the battery cover (C) and remove the battery (D).

33
Device overview

1.3 Turning on or off the device

Refer to the following illustration for location of the power button and power indicator. Follow the
instructions to turn your SONON ultrasound device on or off.

[SONON 300C, 300L]

Turning on the device

Press and hold the power button for longer than 2 seconds. The Power LED will turn on white, then
the Wi-Fi LED will turn on after a few seconds.

Turning off the device

Press and hold the power button for longer than 2 seconds. The power LED will change to green for a
few seconds, then turn off.

NOTE
• The Wi-Fi connection will become available a few seconds after the device is turned on. Wait until the
Wi-Fi LED turns on before attempting to connect the SONON ultrasound device to your mobile
device.
• The SONON ultrasound device must be connected to your mobile device before you can start
scanning.

34
 Installing and registering the software

2 Installing and registering the software

You must install the HEALCERION app (SONON X ultrasound app) on your mobile device and
complete registration before you can connect the SONON ultrasound device to your mobile device
and begin scanning.

Touchscreen gestures
The following touchscreen gestures are used in this manual to describe user interactions on the
screen.
Interaction Gesture Action Description Function

Launch an
Briefly touch screen
Tap
• Select
and remove finger
app, select an
• Run item, or run a
function.

• Move items
Move an item
• Scroll
Move finger while
Drag or scroll
up/down/across touching screen
through a list

Move two fingers

Enlarge or
apart or together
Pinch out / • Zoom in
while touching
minimize a
Pinch in • Zoom out screen with both
part of an
image
fingers

35
Installing and registering the software

System requirements for mobile devices

The following tables list mobile device system requirements for installing and using the HEALCERION
app (SONON X ultrasound app).

Operating system versions

Operating system Requirement
iOS iOS 12.0 or later
Android Android 7.0 (Nougat) or later
Windows (UWP) Windows 10 (64-bit) or later

Minimum specifications for mobile devices

CPU 1.7GHz
Core 8 cores
RAM 4GB
Resolution 2560 X 1600 (287ppi)

NOTE
HEALCERION does not guarantee normal operation of the SONON ultrasound device or the
HEALCERION app (SONON X ultrasound app) when they are used with other mobile devices that have
not been tested for compatibility.

36
 Installing and registering the software

2.1 Installing the HEALCERION app (SONON X ultrasound

app)
Follow the instructions below to install the HEALCERION app (SONON X ultrasound app) on your
mobile device.

CAUTION
• Appropriate data safety measures must be taken with patient data because the SONON ultrasound
device stores diagnostic data on a personal mobile device. It is your responsibility to keep patient
data safe and secure.
• All stored data will be lost if you uninstall the HEALCERION app (SONON X ultrasound app). Back
up all important data and store the backup files on a separate storage device before uninstalling the
app or replacing your mobile device.
• The data stored on a mobile device cannot be recovered if the mobile device is lost. To prevent such
data loss, back up your data on a regular basis.

For Apple (iOS) smart devices

1 On your Apple smart device, tap to launch the App Store.

2 Tap , type “HEALCERION” or “SONON” in the search window, and tap .

3 From the search results, select the SONON X Ultrasound app and tap INSTALL.

4 Enter your Apple iTunes password.

For Android smart devices

1 On your Android smart device, tap to launch the Play Store.

2 Type “HEALCERION” or “SONON” in the search window and tap .

3 From the search results, select the SONON X Ultrasound app and tap INSTALL.

4 When the installation is completed, tap OPEN to launch the app.

For Universal Windows Platform (UWP) smart devices

1 On your UWP smart device, tap to launch the Windows Store.

2 Type “HEALCERION” or “SONON” in the search window and tap .

3 From the search results, select the SONON X Ultrasound app and tap INSTALL.

4 When the installation is completed, tap OPEN to launch the app.

37
Installing and registering the software

2.2 Registering user information

Registration of your user information is required to launch the HEALCERION app (SONON X
ultrasound app) for the first time. Follow the instructions below to register your information within the
app or server.

NOTE
In some countries, user information can only be registered through the app. In this case, registering
through the server is not supported.

How to register user information in the app storage

1 On your mobile device, tap to launch the HEALCERION app (SONON X ultrasound app),
then tap NO.

2 Read the terms and conditions and tap the “I

Agree” checkboxes to proceed.

3 Enter your email address, device serial number,

and password, then tap OK.

4 Review your registration information and tap OK

to close the confirmation popup window.

NOTE
If the current version only supports registration through the app, the selection screen is not shown.

38
 Installing and registering the software

How to register user information through the server

1 On your mobile device, tap to launch the HEALCERION app (SONON X ultrasound app),
then tap Yes.

2 On the Log in
screen, tap Sign
up.

3 Read the terms and

conditions and tap
the “I Agree”
checkboxes to
proceed.

4 Enter your ID(email

address),
password, your
name, phone
number,
organization,
occupation, and
country then tap
OK.

5 Tap OK to close the

pop-up window,
then refer to the
email to complete
registration.

39
Installing and registering the software

NOTE
• Write down your password and keep it in a secure place. You cannot start the app if you forget your
password. See “Finding a forgotten password (When user information is stored on the server)”on
page to reset a password.

2.3 Starting an exam for the first time

Follow the instructions below to perform an exam for the first time.

Connecting the device with Wi-Fi

The SONON ultrasound device must be connected to your mobile device before you can start
scanning.

NOTE
Disable “Power Saving (Low Battery)” features on your mobile device before attempting to connect your
mobile device to the SONON ultrasound device. On some mobile devices, network connection to the
SONON ultrasound device fails if the mobile device is running in power saving mode.

1 Turn on the SONON ultrasound

device by pressing and holding the
power button for at least 2 seconds,
and wait until the Wi-Fi LED turns
on.

2 Go to the Wi-Fi settings menu on

your mobile device and search for
the SSID of your SONON device
(SSID: SONONXXXX-YYYYYYYY.
X=model name, and Y=serial
number).

3 Select your device from the SSID list and enter the default password (“1234567890”).

40
 Installing and registering the software

Starting a scan

WARNING
• Do not use the SONON ultrasound device for ophthalmic use.
• Do not allow the acoustic beam to pass through the eye.

CAUTION
• This device should be used in compliance with applicable laws. Some jurisdictions restrict certain
uses, such as gender determination.
• Allow the device to rest for 10 minutes after 10 minutes of scanning.
• Do not use gels (lubricants) that are not approved by HEALCERION. They may damage the probe
and void the warranty.

1 On your mobile device, tap to launch the HEALCERION app (SONON X ultrasound app).

2 Enter your ID(Email address) and

password and tap Log in.

3 On the home screen, tap Start Scan.

41
Installing and registering the software

4 Tap in the menu area. A list of presets

will be displayed.

5 From the list, select an appropriate preset

for your exam.

NOTE
When user information is registered in the app storage, you can log in to the HEALCERION app
(SONON X ultrasound app) by entering the password.

NOTE
Default display mode may vary depending on the type and screen size of your mobile device.

You can tap to show the menu area if the scan begins in full screen mode.

CAUTION
An appropriate preset for your application must be selected before you begin a scan. The accuracy
of your diagnostics will be affected if you proceed with your scan without selecting an appropriate
preset.

NOTE
• Scan begins in B mode by default. Select an appropriate mode for your examination needs.
• See “4.1 Utilizing presets” on page for detailed information about using the default presets, making
changes to them, and creating new presets.

42
 Installing and registering the software

Quick scan in QUICK SCAN mode

If it’s urgent, you can initiate a quick scan without logging in.

NOTE
 You must log in at least once with your registered user information to enable QUICK
SCAN mode.
 Videos scanned with QUICK SCAN are for viewing only and will not be saved.
 Quick scan is used to see the corresponding image upon an emergency. Therefore, all
features are not provided except viewing include freeze function.
 Quick scan provides only the measure function to acquire the value in Freeze mode.

1 On the Log in screen, tap QUICK SCAN.

2 Tap in the menu area. A list of presets

will be displayed.

3 From the list, select an appropriate preset

for your exam.

43
User interface and scan modes

3 User interface and scan modes

3.1 User interface and screen settings
When you tap Start Scan on the home screen, the scan screen will be displayed on your mobile
device. The following are features available in each section of the scan screen.

Scan screen interfaces

NOTE
Default display mode may vary depending on the type and screen size of your mobile device.

You can tap to show the menu area if the scan begins in full screen mode.

The following user interfaces are available on the scan screen.

Display/Icons Name Description
Indicates the currently selected patient, and
Patient name and ID (Exam
the date and time of the exam.
date and time if ID is not
All recorded exams will be saved under the
assigned)
patient’s account.

Displays the status of the network connection

between your mobile device and the SONON
Network and battery status
ultrasound device, and the remaining battery
charge for the SONON ultrasound device.

Displays the marker position. You can tap

Marker position / the icon to reverse the screen (L-R/R-L).
Reverse screen Reverse function is only available in
Unfreeze mode.

44
 User interface and scan modes

Displays the gray scale of the selected

grayscale preset in B mode.
Gray scale bar (B mode) /
Displays the color scale based on the CF
Color scale bar (CF mode)
mode parameter settings, such as flow
speed, in CF mode.

Displays the live-scanned or recorded videos

in dual screen mode. Dual screen mode will
Dual Screen Mode
allow you to check reference videos more
easily.

Date and time Displays the date and time.

Organization information / Displays the organization information and

Physician name Physician name.
Acoustic output power
Displays MI and TI values.
indicator

Displays the following scan parameters.

• Selected preset
Scan properties • Scan frequency
• Magnification of image
• Current frame rate of the scan

Focus and depth control Tap on the control bar to set a focus.
bar Drag on the control bar to set a scan depth.

Tap to hide the menu area and expand

Full screen / partial screen the scan screen into full screen mode.
button
Tap to show the menu area and shrink
the scan screen into partial screen mode.

45
User interface and scan modes

Menu area interfaces

NOTE
Default display mode may vary depending on the type and screen size of your mobile device.

You can tap to show the menu area if the scan begins in full screen mode.

The following user interfaces are available in the menu area.

Display/Icons Name/Sub menu Description
The expanded menu provides the following
Expanded menu menu options.
• Preset list: Select an optimized
configuration that suits the type of the
exam.
• Save preset: Save the changes by
overwriting the existing preset, or by
creating a new preset.
• Quick Viewer: Quickly review recorded
exams from the scan screen.
• Settings: Configure hardware and software
settings including network options, set
preferences, and check the firmware
version.
• End Exam: Exit the scan screen and return
to the home screen.
You can tap the patient’s name to open the
Patient List.
Displays the current scan screen mode.
Scan screen mode Unfreeze mode screen displays animated
indicator: images to show the real time changes.
Unfreeze mode / Freeze mode provides a still image to allow
Freeze mode measuring of on-screen objects and addition of
comments.
Displays the SONON ultrasound device model
Device type
name.
Tap this button to exit the scan screen and
Exit
return to the previous screen.
Scan mode selector Tap to select a scan mode.

46
 User interface and scan modes

• B (brightness) mode provides grayscale

images.
• CF (color flow) mode shows the direction
and velocity of flow in red and blue.
• PW (pulsed wave) mode displays different
wave velocities and directions in a
spectrum.
• M (motion) mode displays the changes
over time on a single line graph in a
spectrum.
In this section of the menu, you can configure
various scan screen parameters to achieve
Screen parameter optimal images.
settings See “Configuring screen parameters“ on page
for detailed information about configuring
screen parameters.
Tap this button to record a video file.
Recorded videos can be converted into .mp4 or
Record
DICOM video files (See “Sharing, uploading, or
deleting recorded exams”).
Tap this button to capture the screen as a still
image file. Captured images can be converted
Snapshot
into .jpg or DICOM image files (See “Sharing,
uploading, or deleting recorded exams”).
Tap this button to Freeze or Unfreeze the scan
screen.
Freeze
You can also Freeze/Unfreeze the screen by
using the Freeze button on the device.
This button is displayed on the freeze mode
menu screen only.
Tap this button to measure the length, angle,
circumference, and volume of the objects on the
Measure scan screen and add text notes.

• : Used to measure the length of an

object on the screen.

• : Used to measure the angle of an

object on the screen.

• : Used to measure the circumference

and area of an object on the screen.

• : Used to add a comment.

• : Used to measure the volume of an

object based on its dimensions.

• : Used to measure fetal biometry

parameters on the screen. See “Assessing
fetal biometry ” on page for detailed
information.

Tap to hide the menu area and expand the

Full screen / Partial scan screen into full screen mode.
screen
Tap to show the menu area and shrink the
scan screen into partial screen mode.

47
User interface and scan modes

Configuring screen parameters

NOTE
Default display mode may vary depending on the type and screen size of your mobile device.

You can tap to show the menu area if the scan begins in full screen mode.

The following user interfaces are available in the menu area.

CAUTION
Changing the screen parameter settings can affect image quality and compromise diagnostic accuracy.
It is your responsibility to adjust the display settings appropriately to obtain desirable image quality.

Menu screen Name Description/Default

• Gain: Adjust the intensity of the signal on
the screen. Raising gain increases the
brightness of the images.
• DR (Dynamic Range): Set the amplitude
range in which the device operates. Higher
B Mode dynamic range results in softer images with
reduced contrast.
Image
Parameters • TGC (Time Gain Compensation): Adjust
the sensitivity of the ultrasound waves
according to depth of body area. You can
adjust the brightness separately for the 4
screen areas.
• Auto Gain: Initialize Gain and TGC settings
to preset values (Default: on).

48
 User interface and scan modes

• Frame Average: Set the frame average

(Off, level 1, 2, 3). Higher levels produce
smoother images with lower resolution.
• SRI (Speckle Reduction Imaging): SRI
Filter Image improves the image quality of a B mode
Parameters scan.
• Graymap: Determine how the scan is
expressed on the screen based on signal
strength. Select the preset which best fits
your needs.

• Multi-focus: Enable or disable multi-

focusing. Multiple focus increases
resolution with low frame rates (Default:
OFF).
Multi focusing is only available on the 300L,
in B mode.
• Frequency: Set the ultrasound wave
Others frequency according to the area of the
Image exam.
Parameters Frequency is only available on the 300L, in
B mode.
[Example]
• 3.5 MHz: abdomen, deeper organs
• 10 MHz: thyroid, shallower organs
• Center Line: Display a vertical center line
on the scan screen.
• Invert: Inverts colors of vessel flow.
• Angle Steer: Adjust angle steer of the ROI
(region of interest) box.
• Color Box Size: Resize ROI (Region of
interest) Box. Large ROI Box can only be
used when Depth is more than 1.96 in. (5
cm).
CF mode
parameters • Flow Speed: Control PRF (Pulse Repetition
Frequency) to adjust velocity scale.
• C Gain (Color Doppler Gain Control):
Adjusts the intensity of the signal on the
screen in CF mode. Raising gain increases
the color sensitivity of the image.
• Rejection: Suppress low signal and reduce
noise in the signal.

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User interface and scan modes

• Invert: Inverts speed range.

• Pause Doppler: Pauses to display the
Doppler spectrum in real time.
• PRF(Pulse Repetition Frequency): Adjusts
the PRF. As the PRF increases, the
velocity range displayed in a spectrum
becomes wider. By increasing its depth, the
maximum PRF can be decreased.
• DR: Sets the amplitude range in which the
device operates. Higher dynamic range
results in softer images with reduced
contrast.
• Wall Filter: Adjusts the wall filter. By
increasing the wall filter, the velocity
components that are not concerned are
PW mode removed.
parameters • Sample Volume: Adjusts the sample
volume area. By increasing this sample
volume, various velocity components can
be detected.
• Correction Angle: Adjusts the correction
angle. Adjust the correction angle to detect
correct velocity components.
• Base Line: Adjusts the baseline to
represent the Doppler spectrum as a single
continuous signal.
• Sweep Speed: Adjusts the sweep speed.
By increasing the sweep speed, the time
range displayed in a spectrum can be
increased.
• Sound Volume: Adjusts the sound volume
for the pulsed Doppler signal in PW mode.

• Sweep Speed: Adjusts the sweep speed.

M mode By increasing the sweep speed, the time
parameters range displayed in a spectrum can be
increased.

NOTE
• In CF mode, a yellow ROI box is displayed on the screen to specify the region to be observed.

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 User interface and scan modes

Device orientation
Your SONON device has a notch on one side of the head to help you determine the orientation of the
transducer on the scan screen. This notch is used to identify the side of the device corresponding to
the left side of the image on the scanning screen which has an orientation mark.

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User interface and scan modes

3.2 Selecting operating modes

Refer to the following information about the operating modes available on your SONON ultrasound
device. Some operating modes explained in this manual may not be supported in certain SONON
ultrasound devices.

B mode operation (brightness mode, or 2D mode)

In B mode, images are displayed in grayscale.

After you tap Start Scan on the home screen, scan begins in B mode by default.

NOTE
If you are in CF mode, tap on the menu to switch to B mode.

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 User interface and scan modes

B mode specific settings

You can adjust the following settings in B mode.
Menu screen Name Description/Default

Multi-focus: Enable or disable multi-focusing.

Other image Multiple focus increases resolution by lowering
parameters the frame rate (default: off). Multi focusing is
available on the 300L only.

CF mode operation (color flow mode)

In CF mode (also known as “color doppler mode”), different velocity and direction of flow is displayed
in different colors.

After you tap Start Scan on the home screen, scanning begins in B mode by default. Tap on the
mode select menu to switch to CF mode.

NOTE
• In CF mode, a yellow ROI box is displayed on the screen to specify the region to be observed.

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User interface and scan modes

CF mode specific settings

You can adjust the following settings in CF mode.
Menu screen Name Description/Default
• Invert: Inverts colors representing vessel flow.
• Angle Steer: Adjusts the Angle Steer of the
ROI (region of interest) box.
• Color Box Size: Resizes ROI (region of
interest) box. Large ROI Box can only be used
when Depth is more than 1.96 in. (5 cm).
CF mode
settings
• Flow Speed: Controls PRF (Pulse Repetition
Frequency) to adjust velocity scale.
• C Gain (Color Doppler Gain Control): Adjusts
the intensity of the signal on the screen in CF
mode. Raising gain increases the color
sensitivity of the screen.
• Rejection: Suppresses low signal and reduces
signal noise.

PW mode operation (pulsed wave mode)

In PW mode (also known as “pulsed wave mode”), different velocity and direction of flow is displayed
in spectrum.

After you tap Start Scan on the home screen, scanning begins in B mode by default. Tap on the
mode select menu to switch to PW mode.

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 User interface and scan modes

NOTE
• In PW mode, a yellow line is displayed on the screen to specify the region to be observed.
• Select the region of observe as a touch event.

PW mode specific settings

You can adjust the following settings in PW mode.
Menu screen Name Description/Default
• Invert: Inverts speed range.
• Pause Doppler: Pauses to display the
Doppler spectrum in real time.
• PRF(Pulse Repetition Frequency): Adjusts
the PRF. As the PRF increases, the
velocity range displayed in a spectrum
becomes wider. By increasing its depth,
the maximum PRF can be decreased.
• DR: Sets the amplitude range in which the
device operates. Higher dynamic range
results in softer images with reduced
contrast.
• Wall Filter: Adjusts the wall filter. By
increasing the wall filter, the velocity
components that are not concerned are
PW mode removed.
parameters • Sample Volume: Adjusts the sample
volume area. By increasing this sample
volume, various velocity components can
be detected.
• Correction Angle: Adjusts the correction
angle. Adjust the correction angle to detect
correct velocity components.
• Base Line: Adjusts the baseline to
represent the Doppler spectrum as a single
continuous signal.
• Sweep Speed: Adjusts the sweep speed.
By increasing the sweep speed, the time
range displayed in a spectrum can be
increased.
• Sound Volume: Adjusts the sound volume
for the pulsed Doppler signal in PW mode.

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User interface and scan modes

M mode operation (motion mode)

In M mode (also known as “motion mode”), the changes over time on a line graph appears in a
spectrum.
After you tap Start Scan on the home screen, scanning begins in B mode by default. Tap on the
mode select menu to switch to M mode.

NOTE
• In M mode, a yellow line is displayed on the screen to specify the region to be observed.
• Select the region of observe as a touch event.

M mode specific settings

You can adjust the following settings in M mode.
Menu screen Name Description/Default

• Sweep Speed: Adjusts the sweep speed.

M mode By increasing the sweep speed, the time
parameters range displayed in a spectrum can be
increased.

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 Utilizing scan screen features

4 Utilizing scan screen features

The SONON ultrasound device provides various scan screen features, such as dual screen review,
zooming, focus and depth adjustment, recording, preset selection, and measurement of on-screen
objects.

NOTE
Measuring features are available in Freeze mode only.

Unfreeze/Freeze mode screens

By default, the scan screen is presented in Unfreeze mode, allowing all changes to be observed in
real time.

You can press the Freeze button ( ) on the device or on the app screen to switch to Freeze mode.
On the Freeze mode screen, you can observe and analyze a still image of a scan and measure the
on-screen objects according to your diagnostic needs.

4.1 Utilizing presets

Presets allow you to conveniently apply the appropriate settings for different applications. The
SONON X Ultrasound app provides the following default presets with typical settings optimized for
different types of exams.

NOTE
Available number and types of presets vary depending on the model of your SONON device.

Presets for the SONON 300C

• Abdomen • Early OB
• Bladder • Late OB
• FAST • GYN

Presets for the 300L

• Thyroid • Vascular
• Carotid • Superficial
• Breast • MSK

You can select one of the presets to immediately apply multiple setting parameters optimized for each
application. After selecting a preset, you can make changes to the detailed screen or exam settings and
save the changes by overwriting the existing preset, or by creating a new preset.

CAUTION
Changing the display settings can affect image quality and compromise diagnostic accuracy. It is your
responsibility to adjust the display settings appropriately to obtain desirable image quality.

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Utilizing scan screen features

Selecting a preset
Follow the instructions below to select a preset for your application.

1 Tap in the menu area to see the expanded menu. A list of presets is displayed.

2 Select a preset from the list.

NOTE
On the Unfreeze mode screen (default), you can instantly see the results of selecting different presets.

Saving a preset after making parameter changes

After selecting a preset, if you have made changes to the screen or exam parameters to suit your
specific needs, you can save the changes to the currently selected preset, or create a new preset to
save your settings.
See “Configuring screen parameters” on page 53 for detailed information about setting screen and
exam parameters.

NOTE
On the Unfreeze mode screen (default), you can instantly see the results of screen parameter changes.

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 Utilizing scan screen features

Saving changes to an existing preset

Follow the instructions below to save changes to a currently selected preset.

1 Tap in the menu area to open the expanded menu.

2 Tap Save Preset > Overwrite. Changes will be saved to the current preset.

NOTE
An asterisk (“*”) will be displayed at the end of the preset name if you overwrite a default preset after
making changes.

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Utilizing scan screen features

Creating a new preset after making changes

Follow the instructions below to save your changes as a new preset.

1 Tap in the menu area to open the

expanded menu.

2 Tap Save Preset > Save As.

3 Enter a new preset name and tap OK. A

new preset will be created in the list of
presets.

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 Utilizing scan screen features

4.2 Utilizing imaging features

Zooming in and zooming out

Whenever a closer look at the scan screen is needed during a scan, you can zoom in or zoom out on
any section of the screen by pinching out or pinching in on the screen with your fingers.

NOTE
Up to 400% magnification is available when you zoom in.

Adjusting scan focus (FL: Focal Length)

You can adjust focal length (FL) to set the focus of a scan to a desired depth.
Tap on the side bar on the right edge of the screen to set a focal length.

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Utilizing scan screen features

NOTE
• Available range of focal length (FL) varies by model.
- SONON 300C: 0.78-6.29 in. (2-16 cm)
- 300L: 0.19-2.36 in. (0.5-6 cm)
• MI (mechanical index) and TI (thermal index) values will change in accordance with the focus
change. See “Acoustic output parameters” on page for detailed information about the mechanical
and thermal index parameters.
• FL cannot be set beyond Depth (scan depth). If you try to set FL beyond the available Depth, it will
be automatically adjusted to 0.39 in. (1 cm) less than Depth (Depth – 0.39 in. [1 cm]).

Adjusting scan depth (Depth)

You can adjust scan depth (Depth) to set the distance the ultrasound waves travel into the patient’s
body.
Drag your finger up and down on the side bar on the right edge of the screen until the desired scan
depth is achieved.

NOTE
• Available range of depth (Depth) varies by model.
- SONON 300C: 1.57-9.45 in. (4-24 cm)
- 300L: 1.18-3.93 in. (3-10 cm)
• Depth cannot be set shallower than FL (Focal Length). If you set Depth to a length shorter than FL,
FL will be automatically adjusted to 0.39 in. (1 cm) less than Depth (Depth – 0.39 in. [1 cm]).

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 Utilizing scan screen features

4.3 Recording and reviewing exams

You can record your exams as video or image files, and quickly review them in the Quick Viewer or
Snapshot Slider. You can also review for your exams using the dual screen.

Recording exam videos

Follow the instructions below to record exams as video files.

1 Tap in the
menu area to begin
recording. A status
message
(“Recording…”) will
be displayed on the
screen to indicate
that the exam is
being recorded.

2 To stop recording,

tap in the
menu area again. A
status message
(“File saved”) will
be displayed on the
screen to indicate
that the recorded
video has been
saved.

Capturing images
Tap in the menu area during an exam to capture a screen as an image file. A status message
(“File saved”) will be displayed to indicate that the captured image has been saved.

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Utilizing scan screen features

Playing back recorded exams with Quick Viewer

Follow the instructions below to quickly review recorded videos and images.

NOTE
You can also play back recorded videos and captured images in the Patient List. See “5.2 Reviewing
and handling exam records” on page for detailed information.

3 Tap to open the expanded menu.

4 Tap Quick Viewer to open the playlist.

5 Select a video or image to play back.

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 Utilizing scan screen features

Playing back recorded exams with Snapshot Slider

1 Enter review mode after selecting a video or image.

2 Tap to open Snapshot slide.

3 Drag the Snapshot slide to the left or right, then tap the image or video you want.

4 Tap to close Snapshot slider.

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Reviewing exams in Dual screen

Dual screen’s various review modes will allow you to review for your exams much more conveniently
and easily.

Starting Dual screen mode

1 Tap in scan mode, then tap or to start dual screen mode.

The reference sources for comparison, such as recorded images, videos, or freeze mode will be
displayed on the left screen while in dual screen.
Images to review will be displayed on the right screen while in dual screen.

2 Tap to close Dual screen mode.

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 Utilizing scan screen features

Utilizing Dual screen mode

Scan mode supports the following dual screen modes:

Live freeze + Live scan

Tap > while scanning.
You can review the live-scan image while referring to a freeze image.

NOTE
The control options available in dual screen mode are below. For more info, please check the
corresponding page.

• Tap to measure objects on the screen. (“4.4 Measuring on-screen objects”)

• Tap to capture image. (“Capturing images”)

• Tap to change screen parameter settings. (“Configuring screen parameters”)

• Tap to record video. (“Recording exam videos”)

• Tap to freeze the scan screen. (“Starting Freeze mode”)

Live freeze + Review

Tap > while scanning, then select the scanned image.
You can review scanned images while referring to a freeze image.

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Utilizing scan screen features

NOTE
The control options available in dual screen mode are below. For more info, please check the
corresponding page.

• Tap to measure objects on the screen. (“4.4 Measuring on-screen objects”)

• Tap to capture image. (“Capturing images”)

• Tap to change screen parameter settings. (“Configuring screen parameters”)

• Tap to open Snapshot Slider (“Playing back recorded exams with Snapshot Slider”)

• Tap to play back a video. (“Playing recorded videos”)

Review + Live scan

Select the scanned image and tap > .
You can review the live-scan image while referring to a scanned image.

NOTE
The control options available in dual screen mode are below. For more info, please check the
corresponding page.

• Tap to open Snapshot Slider (“Playing back recorded exams with Snapshot Slider”)

• Tap to measure objects on the screen. (“4.4 Measuring on-screen objects”)

• Tap to capture image. (“Capturing images”)

• Tap to play back a video. (“Playing recorded videos”)

• Tap to change screen parameter settings. (“Configuring screen parameters”)

• Tap to record video. (“Recording exam videos”)

• Tap to freeze the scan screen. (“Starting Freeze mode”)

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 Utilizing scan screen features

Review + Review
You can compare and review scanned images.

1 Select the scanned image and tap > .

2 Select the image to review.

NOTE
The control options available in dual screen mode are below. For more info, please check the
corresponding page.

• Tap to open Snapshot Slider (“Playing back recorded exams with Snapshot Slider”)

• Tap to measure objects on the screen. (“4.4 Measuring on-screen objects”)

• Tap to capture image. (“Capturing images”)

• Tap to play back a video. (“Playing recorded videos”)

• Tap to change screen parameter settings. (“Configuring screen parameters”)

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Utilizing scan screen features

4.4 Measuring on-screen objects

In Freeze mode, you can measure objects on the screen and leave comments on the scan images.

Starting Freeze mode

Tap on the scan screen, or press the Freeze button ( ) on your SONON 300C, 300L device, to
start Freeze mode.

NOTE
• The scan status indicator in the menu area displays the current scan mode as you switch between
Unfreeze and Freeze modes.

• During a measurement, a rewind bar is displayed at the bottom of the scan screen. You can drag the
handle of the rewind bar to review saved images in the buffer (The buffer temporarily stores up to 150
frames).

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 Utilizing scan screen features

Measuring lengths
After switching to Freeze mode, follow the instructions below to measure the length of an object.

1 Tap to open the Measure menu.

2 Tap to start measuring.

3 Tap a starting point (A), then tap an ending

point (B).

A yellow line will be displayed connecting the

two points, and the distance between (A) and
(B) will be displayed in yellow (in mm).

4 Tap to capture measurements on the screen. A message (“File Saved”) will be displayed to
indicate that the captured image has been saved.

NOTE
• When there are multiple measurements on the screen, the currently selected measurement is
displayed in yellow and others are displayed in green.
• You can move a measurement around the screen by dragging its center point.
• To save measurements, capture the screen before switching to Unfreeze mode. All measurements
on screen will be deleted when you leave Freeze mode.

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Utilizing scan screen features

Measuring angles
After switching to Freeze mode, follow the instructions below to measure the angle of an object.

1 Tap to open the Measure menu.

2 Tap to start measuring.

3 Tap a starting point (A), then tap an ending

point (B).
A yellow line will be displayed connecting the
two points. A center point (C) will be
automatically generated and the angle of the
section (A)-(C) against section (C)-(B) will be
displayed in yellow (in °).

4 Tap to capture measurements on the

screen. A message (“File Saved”) will be
displayed to indicate that the captured image
has been saved.

5 You can drag the three points freely to create an angle (in °).

NOTE
• When there are multiple measurements on the screen, the currently selected measurement is
displayed in yellow and others are displayed in green.
• You can move a measurement around the screen by dragging its center point.

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 Utilizing scan screen features

• To save measurements, capture the screen before switching to Unfreeze mode. All measurements
on screen will be deleted when you leave Freeze mode.

Measuring circumferences and areas

After switching to Freeze mode, follow the instructions below to measure the circumference and area
of an object.

1 Tap to open the Measure menu.

2 Tap to start measuring.

3 Tap a starting point (A) and an ending point

(B).
• A yellow axis connecting the two points,
and an ellipse passing through the two
points, will be displayed.
• Two more points on the perpendicular
axis, as well as the center point, will be
automatically generated.
• The circumference and area of the
ellipse will be displayed in yellow
numbers (in mm/mm2).
4 Modify the shape by freely dragging the four points on the ellipse, or move the ellipse by dragging
the center point, to measure the exact area.

5 Tap to capture measurements on the screen. A message (“File Saved”) will be displayed to
indicate that the captured image has been saved.

NOTE
• When there are multiple measurements on the screen, the currently selected measurement is
displayed in yellow and others are displayed in green.
• You can move a measurement around the screen by dragging its center point.

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Utilizing scan screen features

• To save measurements, capture the screen before switching to Unfreeze mode. All measurements
on screen will be deleted when you leave Freeze mode.

Measuring volumes
After switching to Freeze mode, follow the instructions below to measure the volume of an object.

1 Tap to open the Measure menu.

2 Tap to start measuring.

3 Measure the length and width of the object.

• Tap Width, then tap a starting point
(A) and an ending point (B).
A yellow line will be displayed
connecting the two points, and the
distance between A and B will be
displayed (in mm).
• Tap Length, then tap a starting point
(C) and an ending point (D).
A yellow line will be displayed
connecting the two points, and the
distance between (C) and (D) will be
displayed (in mm).

4 Tap to switch back to Unfreeze mode, and scan from a different angle to measure the height
of the object.

5 After locating the object on the scan screen, tap to restart Freeze mode and tap to open
the Measure menu.

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 Utilizing scan screen features

6 Tap Height, then tap a starting point (E)

and an ending point (F).
A yellow line will be displayed connecting
the two points, and the distance between
(E) and (F) will be displayed (in mm).

The dimensions and calculated volume are

displayed on the screen (in mm and mL).

7 Tap to capture the measurements on the screen. A message (“File Saved”) will be displayed
to indicate that the captured image has been saved.

NOTE
• When there are multiple measurements on the screen, the currently selected measurement is
displayed in yellow and others are displayed in green.
• You can move a measurement around the screen by dragging its center point.
• To save measurements, capture the screen before switching to Unfreeze mode. All measurements
on screen will be deleted when you leave Freeze mode.

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Utilizing scan screen features

Leaving comments
After switching to Freeze mode, follow the instructions below to leave a comment on the screen.

1 Tap to open the Measure menu.

2 Tap , then tap the scan screen to add

a comment.

3 Type your comment, the tap OK on the keypad.

4 Tap to capture the comment on the screen. A message (“File Saved”) will be displayed to
indicate that the captured image has been saved.

NOTE
• You can drag a comment to move it on the screen.
• To save comments, capture the screen before switching to Unfreeze mode. Any
comments on the screen will be deleted when you leave Freeze mode.

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 Utilizing scan screen features

Assessing fetal biometry

The SONON 300C ultrasound device provides a measuring mode specially designed for assessing
fetal biometry.
After switching to Freeze mode, you can measure the following fetal biometry parameters on the
measuring screen.

• BPD: Biparietal Diameter

• HC: Head Circumference
• AC: Abdominal
• CRL: Crown Rump
Circumference
Length
• FL: Femur Length

1 Tap to open the Measure menu.

2 Tap to open the fetal biometry

measuring tools.

3 Tap to select each parameter and

complete measuring.

NOTE
See “Measuring lengths” on page and “Measuring circumferences and areas” on page for detailed
procedures for measuring length and circumference.

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Utilizing scan screen features

When you have finished measuring parameters, an estimated fetal weight (EFW) will be automatically
calculated and displayed on the screen.

NOTE
• When there are multiple measurements on the screen, the currently selected measurement is
displayed in yellow and others are displayed in green.
• You can move a measurement around the screen by dragging its center point.
• To save measurements, capture the screen before switching to Unfreeze mode. All measurements
on screen will be deleted when you leave Freeze mode.

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 Utilizing scan screen features

Deleting measurements
Measurements on the screen can be deleted individually or all at once.

Deleting an individual measurement

On the measurement screen, drag a measurement into the trash can to delete it.

Deleting all measurements

On the measurement screen, tap then tap Yes to delete all measurements on the screen.

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Managing patient data

5 Managing patient data

The Patient List provides management features which allow you to register, edit, delete, move, share,
and upload patient data entries.

5.1 Handling patient information

After performing and recording an exam, you can check recorded videos and images, and register
them as patient information entries, in the Patient List.

Registering a patient
Follow the instructions below to add information for a new patient.
6 Tap Patient List on the home screen to open the Patient List.

7 Tap to register a new patient to the

Patient List.

8 Enter patient information such as the

patient’s name, ID number, sex, and DOB.

9 Tap to save the patient data.

NOTE
You can start scanning from the Review screen by tapping (Scan) at the top right corner. All
recorded videos and images will be directly added to the currently selected patient’s exam record.

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 Managing patient data

Deleting patient entries

Follow the instructions below to delete patient entries from the Patient List. You can delete a single
entry, or delete multiple entries at one time.

1 Tap Edit to begin editing.

2 Tap on the Patient List to select a patient

entry, or multiple entries.

3 Tap to delete the selected entries.

4 In the popup window, tap Yes.

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Managing patient data

Editing patient information

Follow the instructions below to modify patient information.

1 Tap a patient entry in the Patient List. The

Review window will open, showing the
patient’s recorded exams as thumbnails.

2 Tap (Profile) to open the patient

information window.

3 Tap to make changes to the patient

information or add a note.

4 Tap to save the data when you are

done editing. A message (“Patient
information saved”) will be displayed to
indicate that the edited information has
been saved.

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 Managing patient data

Merging patient information

Follow the instructions below to merging patient information.

1. Long press a patient entry in the

Patient List. The message window will
open, showing a window to guide
merging.

2. Long press a merging patient entry in

merge mode. The message window
will open, showing a window to guide
merging

3. Tap to merge the patient

information.

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Managing patient data

5.2 Reviewing and handling exam records

In the Review window, you can begin a scan for the selected patient, view previously recorded
exams, and share, upload, or delete previously recorded exams.

NOTE
You can begin a scan from the Review window by tapping . All recorded videos and captured images
will be directly added to the currently selected patient’s exam record.

Playing recorded videos

You can play back recorded video files in the Patient List. While playing back recorded video files, you
can stop a video to examine it, zoom in, measure objects on the screen and save files.

Tap a thumbnail to open a video file.

• Tap to pause a video.

• Tap to play a video again from where it was paused.

NOTE
See “3.1 User interface and screen settings” on page for detailed information about setting the imaging
parameters.

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 Managing patient data

Zooming in and out on the video

To look more closely at a section of the scan screen, you can zoom in or zoom out on any section of
the screen by pinching out or pinching in on the screen with your fingers.

NOTE
Up to 400% magnification is available when you zoom in.

Measuring objects in a video

On a paused screen, you can measure the objects on the screen.

NOTE
See “4.4 Measuring on-screen objects” on page for detailed information about measuring on-screen
objects.

1 Tap to open measuring tools, and select an appropriate tool for your measurement.

• Tap to measure lengths.

• Tap to measure angles.

• Tap to measure circumferences and areas.

• Tap to leave text comments.

• Tap to measure volumes.

• Tap to measure fetal biometry parameters.

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Managing patient data

NOTE
Measurement of fetal biometry parameters is only available on the SONON 300C ultrasound
device. Even when viewing videos taken with a SONON 300C device, measurement of fetal
parameters will not be available if a 300L is currently connected to your mobile device, or if the last
SONON ultrasound device connected to your mobile device was a 300L. Fetal biometry
parameters available for measurement are as follows.

– BPD: Biparietal Diameter

– HC: Head Circumference
– AC: Abdominal Circumference
– CRL: Crown Rump Length
– FL: Femur Length

2 Tap to capture measurements on the screen. A message (“File Saved”) will be displayed to
indicate that the captured image has been saved.

NOTE
When you leave the playback screen, all measurement data will be deleted. If you want to record
measurement data, capture the screen.

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 Managing patient data

Playing back captured images

You can review captured image files in the Patient List.

Tap a thumbnail to open an image file.

NOTE
• You can tap to show full screen view. Full screen view allows you to examine images on a larger
screen.

• See “Configuring screen parameters” on page for detailed information about setting imaging
parameters.

Zooming in and zooming out on an image

Whenever a closer look at the scan screen is needed, you can zoom in or zoom out on any section of
the screen by pinching out or pinching in on the screen with your fingers.

NOTE
Up to 400% magnification is available when you zoom in.

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Managing patient data

Measuring objects

1 Tap to open the measuring tools, and select an appropriate tool for your measurement.

• Tap to measure lengths.

• Tap to measure angles.

• Tap to measure circumferences and areas.

• Tap to leave text comments.

• Tap to measure volumes.

• Tap to measure fetal biometry parameters.

NOTE
See “4.4 Measuring on-screen objects” on page for detailed information about measuring on-screen
objects.

NOTE
Measurement of fetal biometry parameters is only available on the SONON 300C ultrasound device.
Even when viewing videos taken with the SONON 300C devices, measurement of fetal parameters will
not be available if a 300L is currently connected to your mobile device, or if the last device connected to
your mobile device was a 300L. Fetal biometry parameters available for measurement are as follows.

– BPD: Biparietal Diameter

– HC: Head Circumference
– AC: Abdominal Circumference
– CRL: Crown Rump Length
– FL: Femur Length

2 Tap to capture measurements on the screen. A “File Saved” message will be displayed to
indicate that the captured image has been saved.

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 Managing patient data

NOTE
When you leave the playback screen, all measurement data will be deleted. If you want to record
measurement data, capture the screen.

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Managing patient data

Reviewing exam records in Dual screen

You can easily review exam records in the Patient List in dual screen mode.

1 Select an image or
video from the
Patient List.

2 Tap , then tap

or to start
dual screen mode.

The images or videos selected from the Patient List will be displayed on the left screen while in dual
screen.
The live scan image or the image or video to review will be displayed on the right screen while in
dual screen.

3 Tap to close
Dual screen mode.

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Utilizing Dual screen mode

The Patient List supports the following dual screen modes:

Review + Live scan

Select the image or video from the Patient List and tap > .
You can review the live-scan image while consulting the image.

NOTE
The control options available in dual screen mode are below. For more info, please check the
corresponding page.

• Tap to open Snapshot Slider (“Playing back recorded exams with Snapshot Slider”)

• Tap to measure objects on the screen. (“4.4 Measuring on-screen objects”)

• Tap to capture image. (“Capturing images”)

• Tap to play back a video. (“Playing recorded videos”)

• Tap to change screen parameter settings. (“Configuring screen parameters”)

• Tap to record video. (“Recording exam videos”)

• Tap to freeze the scan screen. (“Starting Freeze mode”)

Review + Review
You can compare and review recorded images or videos.

1 Select the image or video from the Patient List and tap > .

3 Select the image to review.

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NOTE
The control options available in dual screen mode are below. For more info, please check the
corresponding page.

• Tap to open Snapshot Slider (“Playing back recorded exams with Snapshot Slider”)

• Tap to measure objects on the screen. (“4.4 Measuring on-screen objects”)

• Tap to capture image. (“Capturing images”)

• Tap to play back a video. (“Playing recorded videos”)

• Tap to change screen parameter settings. (“Configuring screen parameters”)

Sharing, uploading, or deleting recorded exams

1 Go to the Review window of the Patient List, and tap .

2 Tap the thumbnails to select a file or multiple files, then do the followings.

• Tap Share to share the exam records.

• Android : The data is stored in local folders or via e-mail or messenger applications.

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iOS : The data is stored in local folders or via e-mail or messenger applications.

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Managing patient data

• UWP : The data is stored in the picture folder.

✧ Shared file names do not contain patient information.

• Tap to upload the exam records to the PACS (See NOTE).

• Tap to Delete the recorded exam files. All the records saved during the same exam will
be deleted.

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NOTE
• You must complete the DICOM network settings before you can start uploading exams to the PACS.
See “7 DICOM” on page for detailed information.
• You must disconnect your mobile device from the SONON ultrasound device and connect to your
Workplace Wi-Fi before you can start uploading exams.
• On Android mobile devices, you can enable the “Automatically connect to Wi-Fi” option in the Wi-Fi
Setting menu to automatically switch network connections when you upload exams to PACS.

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6 Settings
In the Settings menu, you can adjust hardware and software settings, configure preferences, and
check the firmware version.

6.1 Device settings

In the Device Settings menu, you can manage your Wi-Fi password and check the firmware version.

NOTE
On the home screen, tap Start Scan > > Settings to access the Device Settings menu.
If you access the settings menu by directly tapping SETTING on the home screen, the Device Settings
menu will be disabled in the Settings screen.

Changing Wi-Fi password

Follow the instructions below to change your Wi-Fi password.

NOTE
• The factory default Wi-Fi password is “1234567890”.
• Your new password must be 8–16 characters long.
• After changing the Wi-Fi password, you must reconnect the device to your mobile device with Wi-Fi
before you start scanning.

1 On the home screen, tap Start Scan > > Settings > Device Settings.

2 Tap Change to reset the Wi-Fi password.

3 Enter a new Wi-Fi password and tap OK.

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Factory Mode Reset

In case you cannot remember the Wi-Fi password after changing it, you can initialize device by
factory mode reset. To enter factory mode reset, follow below instructions.

Press the Freeze button and the Wi-Fi button on your SONON ultrasound device simultaneously for
about five seconds.

The Wi-Fi indicator will turn off, then turn on green again, and the SSID and the Wi-Fi password will
be reset to the factory default.

NOTE
• Default SSID: SONONXXXX-YYYYYYYY (X=model name, and Y=serial number)
• Default password: 1234567890

Checking device firmware version

You can tap Start Scan > > Settings > Device Settings to view the current firmware version
installed on the device.

NOTE
When you connect a SONON device with outdated firmware to your mobile device, a popup message
will be displayed requesting an automatic update.

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Settings

6.2 Setting preferences

You can select or configure thermal index (TI) type, choose the size of recorded video files, export file
formats, and select an automatic logout time in the Preferences menu.

On the home screen, tap SETTING > Preference to access these options.

NOTE
You can also access the Settings menu from the scan screen by tapping > Settings.

• Thermal Index: Select type of thermal index (TI)

– TIB: Bone thermal index. Used for fetal applications.
– TIC: Cranial bone thermal index. Used for transcranial applications.
– TIS: Soft tissue thermal index. Used for applications that do not image bones.

NOTE
For the mechanical index (MI), a fixed value is used. See “10.4 Acoustic output” on page for detailed
information.

• Maximum Recording Size: Set the recording time for recorded video files.
• File Type for Export: Select the file formats used for exporting files.
• Auto Logout: Select the time until the user will be automatically logged out when no user
activities are detected.
• Select Language: Select a language.

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6.3 Changing login password

Follow the Instructions below to change the login password for the HEALCERION app (SONON X
ultrasound app).

Changing login password (When user information is stored in app

storage)
1 On the home screen, tap
SETTING > My Information.

2 Enter your current password

and tap OK.

3 Tap the change password

checkbox to change the
password.

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Settings

4 Enter your new password and

tap Change. A popup will be
displayed to inform you that
your password has been
changed.

5 Tap OK to close the popup

window, and log in with the
new password.

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 Settings

Changing login password (When user information is stored on the

server)
1 On the home screen, tap SETTING > My
Information.

2 Tap the change password checkbox to

change the password.

3 Enter your new password and tap Submit.

A popup will be displayed to inform you
that your password has been changed.

4 Tap OK to close the popup window, and

log in with the new password.

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Finding a forgotten password (When user information is stored in app

storage)
In case you cannot remember your login password, follow the instructions below to reset your
password.
1 On the login screen, tap Forgot
password.

2 Enter the email address and the device

serial number registered in the
HEALCERION app (SONON X ultrasound
app), then tap OK.

3 In the popup window, enter a new

password and tap OK. A popup will be
displayed to inform you that your password
has been changed.

4 Tap OK to close the popup window, and log in with the new password.

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 Settings

Finding a forgotten password (When user information is stored on the

server)
In case you cannot remember your login password, follow the instructions below to reset your
password. If you have registered user information on the server, you can reset your password through
your registered email account.

1 On the login screen, fill your email address

and tap.

2 Tap OK in the pop-up window, then check

your email to change your password.

3 Tap Reset password, then enter a new

password and tap Reset. A message will
be displayed to inform you that your
password has been changed.

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Settings

6.4 Managing verified AP list

A network connection to an AP (access point) is required to upload exam files to PACS. In the
Settings menu, you can view the list of verified APs and delete APs that are no longer valid.

1 On the home screen, tap SETTING >

Manage Verified AP.

2 Select APs that are no longer in use and

tap Delete.

6.5 Checking activity logs

You can check the activity logs to track the operation history of your SONON ultrasound device.
On the home screen, tap SETTING > Activity Log to access the activity logs.

NOTE
For users who have registered user information in the server, log information is recorded in the server.

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6.6 Managing preset

Any presets you have changed can be initialized back to the default settings, and you can delete
custom presets you have created.
You can also export custom presets you have created to a file, or import exported presets into the
HEALCERION app (SONON X Ultrasound App).

NOTE
Initializing, deleting, exporting and importing presets can only be performed from the Settings menu. See
“4.1 Utilizing presets” on page for detailed information about making changes to presets and creating
new presets.

Initializing Presets
Follow the instructions below to initialize presets back to the default settings.

NOTE
An asterisk (“*”) at the end of a preset name indicates that the preset has been changed by the user.

1 On the home screen, tap SETTING > Preset.

2 Tap Reset on the right side of the preset to initialize.

3 In the popup window, tap Reset to confirm.

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Deleting presets
Follow the instructions below to delete custom presets you have created.

NOTE
Only custom presets created by the user can be deleted.

1 On the home screen, tap SETTING >

Preset.

2 Tap Delete on the right side of a preset to

delete.

3 In the popup window, tap Delete to

confirm.

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Exporting presets
You can export custom presets you have created to a file.

NOTE
Only custom presets you have created can be exported.

1 On the home screen, tap SETTING >

Preset.

2 Tap Export at the bottom of the screen.

3 Select the preset item you want to export,

then tap Export.

4 Tap OK in the pop-up window.

NOTE
• On Android and iOS devices, exported files are saved in the Documents folder.
• On Windows (UWP) devices, exported files are saved in the Photo folder.

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Importing presets
After exporting the custom preset you created, you can import it back into the HEALCERION app
(SONON X Ultrasound app).

1 On the home screen, tap SETTING >

Preset.

2 Tap Import at the bottom of the screen.

3 Select the preset item you want to import,

then tap Import.

4 Tap OK in the pop-up window.

NOTE
When importing a preset, if there is a preset with the same name, a pop-up window as shown below will
appear. If you want to overwrite the preset to be imported, select Yes.

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6.7 Backing up patient data

To prevent data loss, you can back up files in the Settings menu. Follow the instructions below to
back up patient data.

1 On the home screen, tap SETTING

> Backup.

2 Tap the checkboxes to select

patients to back up, then tap Done.

3 In the popup window, tap Yes.

NOTE
• On Android devices, files backed up are saved to the “BackupFiles” folder of the Documents.
• On iOS devices, files backed up are saved to the “BackupFiles” folder of the SONON X.
• On Windows(UWP) devices, files backed up are saved to the “BackupFiles” folder of the Pictures.

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6.8 Importing backup files

You can import files that were previously backed up. Follow the instructions below to import backup
files.

NOTE
• To import backup files from former versions of the HEALCERION app (SONON ultrasound app), you
must first update the SONON app to the latest version, then proceed with backing up.
• Displayed measurement data will not be supported for imported backup files from former versions of
the HEALCERION app (SONON ultrasound app).

1 On the home screen, tap SETTING >

Import.

2 Select the files(s) you would like to

import, then tap Done.

3 In the popup window, tap Yes.

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6.9 Changing Wi-Fi settings

Follow the instructions below to register SSIDs for your workplace network (Workplace Wi-Fi) and
SONON ultrasound device (Device Wi-Fi).

NOTE
Refer to the following regarding the difference between “Workplace Wi-Fi” and “Device Wi-Fi”
connections.

• Workplace Wi-Fi: A local Wi-Fi network used to connect to PACS (mostly available at hospitals).
• Device Wi-Fi: A Wi-Fi network used to connect the SONON device to a personal mobile device.

Changing Wi-Fi settings on Android mobile devices

1 On the home screen, tap SETTING > Wi-Fi Setting.

NOTE
Enable the “Automatically connect to Wi-Fi.” option in the Wi-Fi Setting menu to automatically switch network
connections when you upload exams to PACS.

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Settings

2 Tap Change beside “Workplace Wi-Fi SSID” and select your workplace Wi-Fi SSID from the list.

3 Tap Change beside “Device Wi-Fi SSID” and select the Wi-Fi SSID for your device from the list.

NOTE
It usually takes a while until the Wi-Fi network connection changes take effect.

Changing Wi-Fi settings on iOS mobile devices

Apple iOS does not allow Wi-Fi setting changes inside the HEALCERION app (SONON X ultrasound
app).
In order to register both the workplace and SONON ultrasound device Wi-Fi connections with an iOS
device, the workplace network connection must be made in the Wi-Fi settings menu of the iOS mobile
device before you attempt to register the SONON ultrasound device.

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 DICOM

7 DICOM settings
You must configure all DICOM settings before you can convert videos and images from the
HEALCERION app (SONON X ultrasound app) to DICOM standard and upload them to the PACS
server.

7.1 Configuring DICOM settings

1 On the home screen, tap SETTING > DICOM.

2 Fill in PACS
Setup, Worklist
Serve Setup, and
Application Setup.

3 When sharing
diagnostic data, or
sending it to PACS,
select the
compression format
for DICOM files.

4 Tap Save to save all information.

NOTE
• You can tap Ping test to ensure that the PACS connection is working.
• PACS must be set up before you can upload DICOM files or update the Work List.

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DICOM

7.2 Configuring DICOM TLS settings

To set up TLS Security settings, you need a public certificate from SCP (server).
Copy the certificate and upload it into the HEALCERION app (SONON X ultrasound app).

NOTE
The storage location and name of the public certificate file is as follows.
• Android: Documents/pacs.pem(or .cer)
• iOS: [SONON X]/pacs.pem(or .cer)
• Windows(UWP): Pictures/pacs.pem(or .cer)

1 On the home screen, tap SETTING > DICOM.

2 Tap “Enable TLS” checkboxes.

3 Tap Load Certificate to load the public certificate file.

4 Tap Save to complete the TLS security settings.

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 DICOM

7.3 DICOM workflow

After configuring the DICOM settings, follow the instructions below to convert videos and images from
the HEALCERION app (SONON X ultrasound app) to DICOM standard and upload them to the PACS
server.

DICOM workflow for Android mobile devices

NOTE
Once you have enabled the “Automatically connect to Wi-Fi” option and selected (registered) the Workplace
Wi-Fi SSID and Device Wi-Fi SSID, you can skip steps 1 and 2 when you upload exams to PACS via the
same workplace network.

1 On the home screen, tap Work List.

2 Launch the HEALCERION app (SONON X ultrasound app) and tap SETTING > Wi-Fi setting.

3 Enable the “Automatically connect to

Wi-Fi” option, and tap Change to
select an SSID for your workplace
network (Workplace Wi-Fi SSID) and
the SONON ultrasound device
(Device Wi-Fi SSID).

4 Set a search condition and tap

Update. The worklist will be loaded
from the server and be saved to the
device automatically.

5 Select a patient from the Work List. Scan screen will be displayed.

6 Perform an exam and save exam images or videos.

7 After the exam, tap Patient List on the home screen.

8 Select a patient from the list.

9 On the Review screen, select exam files and tap . Recorded exam files are automatically
converted to DICOM format, then transmitted to the PACS server.

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DICOM

NOTE
See “Sharing, uploading, or deleting recorded exams” on page for detailed information about selecting
exam files and uploading them to PACS.

DICOM workflow for iOS mobile devices

1 Access your mobile device’s Wi-Fi settings (Settings > Wi-Fi) and connect to the Workplace Wi-
Fi.

2 Launch the HEALCERION app

(SONON X ultrasound app) and
tap Work List on the home screen.

3 Set a search condition and tap

Update. The worklist will be
loaded from the server and be
saved to the device automatically.

4 Minimize the HEALCERION app (SONON X ultrasound app), access your mobile device’s Wi-Fi
settings (Settings > Wi-Fi), and connect to the SONON device via Wi-Fi.

5 Switch back to the HEALCERION app (SONON X ultrasound app) and select a patient from the
Work List. Scan screen will be displayed.

6 Perform an exam and save exam images or videos.

7 After the exam, tap Patient List on the home screen.

8 Select a patient from the list.

9 On the Review screen, select exam files and tap . Recorded exam files are automatically
converted to DICOM format, then transmitted to the PACS server.

NOTE
See “Sharing, uploading, or deleting recorded exams” on page for detailed information about selecting
exam files and uploading them to PACS.

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 DICOM

DICOM workflow for UWP mobile devices

1 Access your mobile
device’s Wi-Fi settings
(Network & Internet
Setting > Wi-Fi) and
connect to the Workplace
Wi-Fi.

2 Launch the HEALCERION

app (SONON X ultrasound
app) and tap Work List on
the home screen.

3 Set a search condition and

tap Update. The worklist
will be loaded from the
server and be saved to the
device automatically.

4 Minimize the HEALCERION app (SONON X ultrasound app), access your mobile device’s Wi-Fi
settings (Network & Internet Setting > Wi-Fi), and connect to the SONON device via Wi-Fi.
5 Switch back to the HEALCERION app (SONON X ultrasound app) and select a patient from the
Work List. Scan screen will be displayed.
6 Perform an exam and save exam images or videos.
7 After the exam, tap Patient List on the home screen.
8 Select a patient from the list.

9 On the Review screen, select exam files and tap . Recorded exam files are automatically
converted to DICOM format, then transmitted to the PACS server.

NOTE
See “Sharing, uploading, or deleting recorded exams” on page for detailed information about selecting
exam files and uploading them to PACS.

7.4 Turning off the device

Press the power button for more than 2 seconds. The Power LED turns green for a few seconds and
then turns off.

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8 Maintenance
The SONON ultrasound device requires regular care and maintenance to function safely and
properly. To ensure that the SONON ultrasound device operates continuously at maximum efficiency,
observe the following procedures as part of your internal routine maintenance program.

CAUTION
• The user must ensure that safety inspections are performed at least every 12 months according to
the requirements of patient safety standard IEC 60601-1 / UL60601-1.
• Only trained technicians are allowed to perform the safety inspections mentioned above.

8.1 Inspecting the SONON ultrasound device

After each use, inspect the lens and casing of the device. Look for any damage that would allow liquid
to enter the device.
Maintenance actions Daily Before/After each use As necessary
Inspect transducer head ✔ ✔ ✔

Clean transducer head ✔ ✔ ✔

CAUTION
• If any damage is found, do not place the device into any liquid (e.g., for disinfection) and stop using it
until it has been inspected and repaired/replaced by a HEALCERION service representative.
• The SONON ultrasound device satisfies IPX7 requirements for being watertight up to a maximum of
1.57 in. (4 cm) from the head (transducer side). Do not immerse the device into any liquid over the
maximum immersion level.

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8.2 Cleaning the SONON ultrasound device

According to the Spaulding Classification scheme, the SONON ultrasound device is classified as a
non-critical device. (Spaulding classification describes potential risk of infection caused by the device
and the appropriate microbicidal processes). FDA recommends thorough cleaning, then intermediate
or low-level disinfection for non-critical devices depending on the nature and extent of the
contamination.

Follow the instructions below when cleaning your SONON ultrasound device.
1) Point-of-Use processing
• After using the product, turn off the SONON ultrasound device.
• Remove coupling gel and other visible substances from the device by wiping with a soft, dry
cloth. Alternatively, use a premoistened disinfectant wipe.
• When removing dried material attached to the surface, the cloth can be moistened with
lukewarm water. Ensure that the cloth is not excessively wet to prevent water from entering
the device.

For a list of compatible cleaning product, see Approved cleaning products on 'Approved cleaning
products'.
2) Cleaning and Disinfecting
• Start at the top of the scanner and wipe toward the scan head with a soft, dry cloth. Be
sure to remove any gels or particulate matter.
• A suitable amount of Gel (See a list of compatible cleaning products) was pasted on head
of device probe, let that dry in room temperature for 1 min.
• After 1 min, cleaned out the Gel of the device probe head with paper towel or Kimwipes.
• Verify that all gel, particulate matter, and bodily fluids have been removed.
• Repeat with new cleaning material if necessary.

• After each cleaning, inspect the lens and casing. Look for any damage that would allow
liquid to enter the device.

CAUTION
If any damage is found, do not place the device into any liquid (e.g., for disinfection) and stop using it
until it has been inspected and repaired/replaced by a HEALCERION service representative.

Approved cleaning products

The cleaning products approved by the manufacturer are as follows.
Product name Manufacturer
Tristel Duo ULT Tristel
Bleach Germicidal Cleaner Clorox

Transeptic Cleansing Sol. Parker

CAUTION
• Do not use cleaning products containing abrasive substances.
• Do not soak or saturate the transducer (device head) with solutions containing alcohol, bleach,
ammonium chloride compounds, hydrogen peroxide, or any incompatible solutions.
• Any damage to the SONON ultrasound device caused by non-approved cleaning
products/substances will not be covered by the product warranty.

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9 Troubleshooting
The sections 9.1-9.3 list system problems (messages), their causes, and suggestions for solving such
problems.
The section 9.4 contains information about reporting security issues.

9.1 Device-related messages

Refer to the following table to find solutions to device-related problems that you may encounter while
using your SONON ultrasound device.
Category Message Cause Solution
Fan control Failure.
Internal fan operation has Turn off the device then
Fan error Please restart
failed. turn it back on.
device.
For safety reasons, the
The micro USB cable has device cannot be operated
Battery is Charging.
Battery been connected to the while it is being charged.
Device will turn off
charging device and the device is Disconnect the micro USB
automatically
being charged. cable before trying to
operate the device.
Device overheated. Preliminary warning: the
Please cool the internal temperature has
device before use. exceeded 149℉ (65℃) Stop operating the device
System Final warning: the internal and wait for 10 minutes
temperature Device overheated. temperature has exceeded before operating the
Device will turn off 167℉ (75℃) device again.
automatically. Device will automatically
shut down.
Low battery. Please
Preliminary warning: Low
turn off and charge
on battery (15%) Stop operating the device
before use.
and charge the battery
Low battery Final warning: Very low on
Low battery. Device before operating the
battery. Device will
will turn off device again.
automatically shut down
automatically.
(10%)

If the messages persist even after taking the suggested solutions, contact HEALCERION and have
the device, battery, battery charger, or AC power adapter serviced.

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 Troubleshooting

9.2 Device connection-related messages

Refer to the following table to find solutions to device connection-related problems that you may
encounter while using the SONON ultrasound device.

NOTE
Disable “Power Saving” features on your mobile device before attempting to connect your mobile device
to the SONON ultrasound device. In some mobile devices, network connection to the SONON
ultrasound device fails if the mobile device is running in power saving mode.

Category Message Cause Solution

Network Network connection
Network connection could not
connection error. Please try
be established. Try again after resetting both
failure connecting again.
the SONON device and the
Disconnected from
Connection Connection to the device has mobile device.
device. Please
terminated been lost.
reconnect.
Find the mobile device that is
Duplicated
The SONON device is already currently connected to the
network Already connected to
connected to another mobile device and terminate the
connection another user.
device. connection before trying
attempt
again.
Firmware Try again after resetting both
Firmware update could not be
upgrade Firmware update failed the SONON device and the
completed.
failure mobile device.

9.3 DICOM network-related messages

Refer to the following table and find solutions to DICOM network-related problems that you may
encounter while using the SONON ultrasound device.
Category Message Cause Solution
Setting PACS information is not PACS has not been
error 1 configured. configured in Settings. On the home screen, tap
Setting Do you wish to set the Work List has not been SETTING > DICOM to
error 2 PACS information? configured in Settings. configure PACS, Work List, and
Worklist server Application information.
information is not set. Do If these fields are already filled
Setting Institution has not been in, verify that all the information
you want to set the
error 3 configured in Settings. is correct.
Worklist server
information?
Tap Yes and follow the on-
screen instructions.
Workplace SSID
Or, on the home screen, tap
Connection information is not set. Do Connection to
SETTING > Wi-Fi Setting. Tap
error 1 you want to set the SSID PACS/Worklist failed.
Change beside “Workplace Wi-
information?
Fi SSID” and select the SSID
for your workplace network.
Cannot Connect to Check with your network
Connection Server Please check Wi-Fi connection to server administrator to ensure that the
error 2 network and server failed. server network is up and
status. running.
On the home screen, tap
Network connection SETTING > Wi-Fi Settings.
Connection
failure. Please try to Connection to PACS failed. Tap Change beside “Device
error 3
connect with the device. Wi-Fi SSID” and select the
SSID for your device.
Connection PACS connection test
Connection to worklist failed. Try all the suggestions above.
error 4 failed.

If the messages persist even after taking the suggested solutions, contact HEALCERION for solutions
and have the device serviced if necessary.

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Troubleshooting

9.4 Reporting security issues

We Healcerion has implemented the following functions for cyber security.
And in the event of a threat related to the cybersecurity of the equipment and software, immediately
stop the equipment or software from working and contact HEALCERION's service personnel to take the
necessary action.

1. Limit Access to Trusted Users Only:

1) Limit access to devices through the authentication of users (e.g. user ID and password, smartcard,
biometric) by Wi-Fi WPA2 PSK encode key and Wi-fi AP

2) Use automatic timed methods to terminate sessions within the system where appropriate for the
use environment

3) There is no multi log-in. Only single account can be registered in one device.

4) The device supports local/server login via a software interface. Users can choose whether to
choose a local login or server login. In the case of server login, the user is verified via an email
verification step to check whether the user uses a valid email account. It does not support multi-factor
authentication.

5) When user registers password, the warning message will be shown to the user for not using the
password which can be inferred. In addition, any hardcoded passwords are not utilized in the
software. No privileged device accounts are used for the purpose of service.

6) Software update can be performed via the OS-specific app store, and authentication may be
required depends on the store policy. In case of firmware update, user can choose whether to
upgrade the firmware or not.

2. Ensure Trusted Content

1) User can upgrade the software via authorized app stores (Android: Play Store, iOS: App Store,
Windows: Microsoft Store). Firmware is protected from unauthorized change by embedding the
firmware within app images. In the case of firmware update, the MD5 hash value of the firmware is
compared to check whether it is a valid or modified file.

2) Users can identify the software version in the authorized OS-specific app store. When the firmware
requires an upgrade, the App pops up the notification that shows the current version and the version
that needs to be upgraded.

3) Using encode channel of Wi-Fi WPA2 (802.11n protocol). Data is encrypted using AES-256.

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3. Detect, Respond, Recover

1) Implement features that allow for security compromises to be detected, recognized, logged, timed,
and acted upon during normal use

: The user can check the app usage log through the Activity Log in the Setting window of the app.
When the user uses cloud-based login, the app usage log is also recorded on the cloud server. The
user cannot delete the log in any cases.

Recorded log contents are as follows:

Screen On/Off, Login/Logout, Image/video saved, Images sent via email/upload/export, Patient data
backed up/extracted, Exam started/over, Patient list created/deleted.

2) Develop and provide information to the end user concerning appropriate actions to take upon
detection of a cybersecurity event
: Description for “In the event of a threat related to the cybersecurity of the equipment and software,
immediately stop the equipment or software from working and contact HEALCERION's service
personnel to take the necessary action” in User Manual

3) Implement device features that protect critical functionality, even when the device’s cybersecurity
has been compromised
: In case of unknown login failure, user can still access to critical functionality of the device via Quick
Scan mode. It is an emergency access mode that provides real-time imaging.

4) Provide methods for retention and recovery of device configuration by an authenticated privileged
user.
: You can store the backup file inside or outside the App and restore data by importing it if necessary.
Backup data is encrypted with AES-256 ZIP compression

9.5 Security note

When using the SONON app, you should pay attention to the following security points.
• Do not install apps on rooted or jailbroken mobile devices. Otherwise, you may be exposed
to multiple vulnerabilities.
• Do not download and install app files distributed outside Play Store (Android), App store
(iOS) or Microsoft Store (Windows)
• If you are using Windows OS, we recommend using a personal PC firewall.
• Periodically perform OS updates on mobile devices and PCs to maintain the latest OS
version. Otherwise, you may be exposed to multiple vulnerabilities.

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10 Technical information
Safety conformance
The SONON ultrasound device conforms to the following safety standards.
• IEC 60601-1 Electrical Medical Equipment
• IEC 60601-1-2 Electromagnetic Compatibility
• IEC 60601-1-6 Usability
• IEC 62304 Software Life Cycle Processes
• IEC 60601-2-37 Particular Requirements for the Safety of Ultrasound Medical Diagnostic and
Monitoring Equipment
• IEC 62359 Ultrasonics – Field Characterization – Test Methods for the Determination of
Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields
• ISO 10993 Biological Evaluation of Medical Devices

Essential performance
The following are the main purposes of using the SONON ultrasound device.
• Acquisition of ultrasound images
• Display of ultrasound images on main display
• Measurement of ultrasound images

10.1 Marking labels

Marking labels are provided to inform users of safety information as well as device specifications.

Marking labels on the device

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ID label
The ID label is attached to the back of the device. You can acquire the following product-related
information from the ID label.

Side label

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Marking labels on power supply accessories

AC adapter
Battery Charger

Power Supply(For device)

Battery charger

WARNING
• Be careful of EMC-related problems when operating the SONON ultrasound device.
• Do not operate the SONON ultrasound device adjacent to or stacked with other equipment.
• Do not use any power adapters or cables other than those provided with the device. Using the wrong
cables or accessories may adversely affect the devices’ EMC performance.

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10.2 Guidance and manufacturer’s declarations

Electromagnetic emissions
The SONON ultrasound device is intended for use in electromagnetic environments as specified
below. It is your responsibility as the operator to ensure that it is operated in an environment
conforming to the following conditions.

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test Compliance Electromagnetic environment - guidance

Radiated disturbance The SONON ultrasound imaging system uses

Group 1 Class B
CISPR 11 RF energy only for its internal functions.
Therefore, its RF emissions are very low and
Mains terminal disturbance are not likely to cause any interference to
voltage Group 1 Class B nearby electronic equipment.
CISPR 11

Harmonics
emission Class A The SONON ultrasound imaging system is
IEC 61000-3-2 suitable for use in all establishments, including
domestic establishments and those directly
connected to the public low voltage power
Voltage supply network that supplies buildings used for
fluctuation Complies domestic purposes.
IEC 61000-3-3

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Electromagnetic immunity
The SONON ultrasound device is intended for use in electromagnetic environments as specified
below. It is your responsibility as the operator to ensure that it is operated in an environment
conforming to the following conditions.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Immunity IEC 60601 Compliance Electromagnetic

test test level level environment - guidance
Floors should be wood,
Electrostatic Discharge by 8 kV Discharge by 8 concrete or ceramic tile. If
discharge direct contact kV direct contact floors are covered with
(ESD) 15 kV of Air-gap 15 kV of Air-gap synthetic material, the relative
IEC 61000-4-2 discharge discharge humidity should be at least
30%.
Radiated RF 10 V/m The SONON ultrasound
10 V/m
electromagnetic field 80 MHz-2.7 GHz imaging system is suitable to
80 MHz-2.7 GHz
immunity 80% AM at 1 use in professional healthcare
80% AM at 1 kHz
IEC 61000-4-3 kHz environment
Portable RF communications
equipment (including
peripherals such as antenna
Immunity to proximity cables and external antennas)
28 V/m Max. 28 V/m Max.
fields from RF should be used no closer than
385-5785 MHz in 385-5785 MHz in
wireless 30 cm (12 inches) to any part
according to according to
communications of the SONON ultrasound
table 9 in IEC table 9 in IEC
equipment imaging system, including
60601-1-2:2014 60601-1-2:2014
IEC 61000-4-3 cables specified by Healcerion.
Otherwise, degradation of the
performance of this equipment
could result
± 2 kV for power
± 2 kV for power supply lines
The quality of supplied power
Electrical fast supply lines ± 1 kV for I/O
should be suitable for
transient/Burst ± 1 kV for I/O lines lines
residence, general business
IEC 61000-4-4 100 kHz repetition 100 kHz
site or hospital environment.
frequency repetition
frequency
The quality of supplied power
± 1 kV line to line
Surge ± 1 kV line to line should be suitable for
± 2 kV line to
IEC 61000-4-5 ± 2 kV line to earth residence, general business
earth
site or hospital environment.

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The strength of RF field in the

3V 3V frequency range 150 kHz~80
0.15-80 MHz 0.15-80 MHz MHz, the strength of the RF
Immunity to 6 V in ISM & 6 V in ISM & field should be smaller than 3
conducted Amateur radio Amateur radio V.
disturbances induced bands between 0.15 bands between
by RF fields and 80 MHz 0.15 and 80 MHz If abnormal performance is
IEC 61000-4-6 80% AM at 1kHz 80% AM at 1kHz observed, additional measures
Power supply line & Power supply may be necessary, such as re-
I/O lines line & I/O lines orienting or relocating the
intraoral sensor.
The quality of supplied power
0 % UT: 0.5
0 % UT: 0.5 cycle should be suitable for
cycle
At 0°, 45°, 90°, residence,
At 0°, 45°, 90°,
Voltage dips, 135°, 180°, 225°, general business site or
135°, 180°, 225°,
Short interruptions 270° and 315° hospital environment.
270° and 315°
and 0 % UT; 1 cycle
0 % UT; 1 cycle
voltage variations and For the user to operate the
and
on power supply 70 % UT; 25/30 equipment continuously even
70 % UT; 25/30
input lines Cycles Single the electric power supply is
Cycles Single
IEC 61000-4-11 phase: at 0º interrupted, it is recommended
phase: at 0º
0 % UT; 250/300 that the uninterruptable power
0 % UT; 250/300
cycle supply device (UPS) or battery
cycle
is prepared.
If degradation of the essential
performance occurs, it may be
necessary to position the
SONON ultrasound imaging
Magnetic field of system further from sources of
supply frequency power frequency magnetic
30 A/m 30 A/m
(50/60Hz) fields or to install magnetic
IEC 61000-4-8 shielding. The power frequency
magnetic field should be
measured in the intended
installation location to assure
that it is sufficiently low.

Note UT is the A.C. voltage supply before the test level voltage.

CAUTION
 If the user uses SONON ultrasound device in the vicinity of the RF sources, it can lower the FPS.
 If it is hard to diagnose due to the low FPS, move the RF sources away from SONON ultrasound
device and the mobile device.

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Separation from other RF wireless communications equipment

The customer or user of the SONON ultrasound imaging system equipment can prevent the
electromagnetic disturbance by maintaining the minimum distance between the portable and mobile
RF wireless communication device and this equipment according to the output power of RF wireless
communication device as follows.

Band Maximum power Distance

Service
[MHz] [W] [m]

380-390 TETRA 400 1.8 0.3

430-470 GMRS 460, FRS 460 2 0.3

704-787 LTE Band 13, 17 0.2 0.3

GSM 800/900,
TETRA 800,
800-960 iDEN 820, 2 0.3
CDMA 850,
LTE Band 5
GSM 1800,
CDMA 1900,
1700-1990 DECT, 2 0.3
LTE Band 1, 3, 4, 25;
UMTS
Bluetooth,
WLAN,
2400-2570 802.11b/g/n, 2 0.3
RFID 2450,
LTE Band 7
5100-5800 WLAN 802.11a/n 0.2 0.3

RF communication equipment is used no closer than 30 cm to any part of the

SONON ultrasound imaging system, including cables specified by Healcerion
- WARNING

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10.3 Applicable standards and test methods in accordance with

IEC 60601-1-2 Ed. 4
Basic EMC
Phenomenon standard or test Port tested Test level/requirement
method
Mains terminal EN55011
AC Mains Group1, Class B
disturbance voltage CISPR11
EN 55011
Radiated disturbance Enclosure Group1, Class B
CISPR11
EN 61000-3-2
Harmonic Current Emission AC Mains Class A
IEC 61000-3-2
Pst: 1
Voltage change, Voltage
EN 61000-3-3 Plt: 0.65
fluctuations and Flicker AC Mains
IEC 61000-3-3 dmax: 4%
Emission
dc: 3.3%
Electrostatic Discharge EN 61000-4-2 ± 8 kV/Contact
Enclosure
Immunity IEC 61000-4-2 ± 2, ± 4, ± 8, ± 15 kV/Air
Radiated RF 10 V/m
EN 61000-4-3
Electromagnetic Field Enclosure 80 MHz-2.7 GHz
IEC 61000-4-3
Immunity 80% AM at 1 kHz
Immunity to Proximity Fields Max. 28 V/m
EN 61000-4-3
from RF wireless Enclosure Table 9 in IEC 60601-1-
IEC 61000-4-3
Communications Equipment 2:2014
± 2 kV
Electrical Fast EN 61000-4-4
AC Mains 100 kHz repetition
Transient/Burst Immunity IEC 61000-4-4
frequency
EN 61000-4-5 Line to Line
Surge Immunity AC Mains
IEC 61000-4-5 ± 0.5 kV, ± 1 kV
3V
0.15 MHz-80 MHz
Immunity to Conducted
EN 61000-4-6 6 V in ISM & Amateur radio
Disturbances Induced by RF AC Mains
IEC 61000-4-6 bands
fields
0.15 MHz-80 MHz

80% AM at 1 kHz
Power Frequency Magnetic
EN 61000-4-8 30 A/m
Field Enclosure
IEC 61000-4-8 50 Hz & 60 Hz
Immunity
0 % UT: 0.5 cycle
At 0°, 45°, 90°, 135°, 180°,
EN 61000-4-11 225°, 270° and 315°
Voltage dips AC Mains
IEC 61000-4-11 0 % UT; 1 cycle and
70 % UT; 25/30 cycles
Single phase: at 0º

EN 61000-4-11
Voltage interruptions AC Mains 0 % UT; 250/300 cycle
IEC 61000-4-11

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10.4 Acoustic output

This section provides information about the acoustic output parameters, their definitions, and the test
reports based on IEC and FDA standards.

Acoustic output parameters

Thermal Index (TI)
The term TI refers to an estimate of the temperature increase of soft tissue or bone. There are three
thermal index categories:

• TIS: Soft tissue thermal index, the main TI category. Used for applications that do not image
bones.
• TIB: Bone thermal index (for bone located in a focal region). Used for fetal applications.
• TIC: Cranial bone thermal index (for bone located close to the surface). Used for transcranial
applications.

References on calculation of TI can be found in:

• NEMA Standards Publication UD 3: “Standard for Real-Time Display of Thermal and

Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment”, Revision 2
• IEC 60601-2-37. Medical Electrical Equipment. Part 2-37: Particular requirements for the
safety of ultrasonic medical diagnostic and monitoring equipment

Mechanical Index (MI)

The term MI refers to the estimated likelihood of tissue damage due to cavitation. The absolute
maximum limit of the MI is 1.9, as set by the U.S. Food and Drug Administration (FDA) 510(k)
guidance on ultrasound systems issued September 9, 2008 (“Guidance for Industry and FDA Staff,
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and
Transducers”).

Ispta
The term Ispta stands for “Spatial Peak Temporal Average Intensity.” The absolute maximum limit of
Ispta is 720 mW/cm2 as set by the FDA 510(k) guidance of September 9, 2008.

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Acoustic output reporting tables for SONON 300C

B(M) mode (IEC 60601-2-37)
IEC 60601-2-37
Clause Requirement + Test Result - Remark Verdict

201.103 TABLE: Acoustic output reporting table -

TIS TIB
Index label MI TIC
Below Below
At surface At surface
surface surface

Maximum index value 0.694 0.274 0.920 N/A

Index component 0.079 0.274 0.691 0.920

pr, α at zMI (MPa) 1.322

P (mW) 21.181 21.181 N/A

P1x1 (mW) 4.585 4.585

Acoustic Zs (cm) 1.150

Parameters Zb (cm) 2.690

ZMI (cm) 2.750

Zpii, α (cm) 2.750

fawf (MHz) 3.631 3.631 3.631 N/A

prr (Hz) 9090.909

srr (Hz) N/A

npps N/A

Ipa, α at z pii, α (W/cm2) 58.745

Other
information Ispta, α at zpii, α or
(mW/cm2) 197.990
zsii, α
Ispta, α at zpii or
(mW/cm2) 394.610
zsii
pr at zpii (MPa) 1.866

Mode B(M)
Operation
control Frequency (MHz) 3.500
conditions
Focal depth (cm) 2.000

B-mode (Track 3 for FDA)

Transducer ISPTA.3 TIS MI IPA.3@MImax

Convex 0.0627 [W/cm2] 0.2535 0.7861 0.1699 [W/cm2]

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CF mode (PW mode) (IEC 60601-2-37)

IEC 60601-2-37
Clause Requirement + Test Result - Remark Verdict

201.103 TABLE: Acoustic output reporting table -

TIS TIB
Index label MI TIC
At Below At Below
surface surface surface surface

Maximum index value 0.736 0.135 0.495 N/A

Index component 0.036 0.135 0.461 0.495

pr, α at zMI (MPa) 1.340

P (mW) 11.162 11.162 N/A

P1x1 (mW) 2.275 2.275

Zs (cm) 1.150
Acoustic
Parameters
Zb (cm) 2.690

ZMI (cm) 2.790

Zpii, α (cm) 2.790

fawf (MHz) 3.311 3.311 3.311 N/A

prr (Hz) 4000.000

srr (Hz) N/A

npps N/A

Other Ipa, α at z pii, α (W/cm2) 64.861

information
Ispta, α at zpii, α or zsii,
(mW/cm2) 102.377
α

Ispta, α at zpii or zsii (mW/cm2) 193.789

pr at zpii (MPa) 1.843

Mode CF(PW)
Operation
control Frequency (MHz) 3.500
conditions
Focal depth (cm) 2.000

#: See tables for constituent modes for values.

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B-mode (with M mode) (FDA)

201.7.9.3.101 TABLE: Acoustic output reporting table
TIS TIB
Index label MI At Below At Below TIC
surface surface surface surface
Global Maximum index value 0.664 0.0927 0.1138

Index component value

pr.3 (MPa) 1.236

W0 (mW) 5.9 5.9

P1x1 (mW)

Acoustic zsp (cm)

Parameters zbp (cm)

zMI (cm)
[email protected] (cm) 2.707
fc (MHz) 3.46 3.46 3.46
PRF (Hz) 2000
srr (Hz)
npps
Other
Ipa.a3 at MImax (W/cm2) 43.8
Information
Ispta.3 max (mW/cm2) 34.2
Ispta at z pii or zsii (mW/cm2)
pr@Pllmax (MPa) 1.58
Control 1
Control 2

Control 3
Operating
Control Control 4
conditions Control 5

Control x

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CF-mode (PW mode) (FDA)

201.7.9.3.101 TABLE: Acoustic output reporting table
TIS TIB
Index label MI At Below At Below TIC
surface surface surface surface
Global Maximum index value 0.757 0.1213 0.1557

Index component value

pr.3 (MPa) 1.379

W0 (mW) 8.09 8.09

P1x1 (mW)

Acoustic zsp (cm)

Parameters zbp (cm)

zMI (cm)
[email protected] (cm) 2.774
fc (MHz) 3.31 3.31 3.31
PRF (Hz) 2000
srr (Hz)
npps
Other
Ipa.a3 at MImax (W/cm2) 61.6
Information
Ispta.3 max (mW/cm2) 49.6
Ispta at z pii or zsii (mW/cm2)
pr@Pllmax (MPa) 1.841
Control 1
Control 2

Control 3
Operating
Control Control 4
conditions Control 5

Control x

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Acoustic output reporting tables for 300L

B(M) mode (IEC 60601-2-37)
201.103 TABLE: Acoustic output reporting table -

TIS TIB

Index label MI Below Below

TIC
At surface At surface
surface surface

Maximum index value 0.429 0.092 0.196 N/A

Index component 0.092 0.087 0.165 0.196

pr, α at zMI (MPa) 1.200

P (mW) 3.993 3.993 N/A

P1x1 (mW) 2.463 2.463

Acoustic Zs (cm) 1.000

Parameters Zb (cm) 2.510

ZMI (cm) 2.580

Zpii, α (cm) 2.580

fawf (MHz) 7.836 7.836 7.836 N/A

prr (Hz) 7812.500

srr (Hz) N/A

npps N/A

Other Ipa, α at z pii, α (W/cm2) 79.552

information
Ispta, α at zpii, α or
(mW/cm2) 94.164
zsii, α

Ispta, α at zpii or zsii (mW/cm2) 380.474

pr at zpii (MPa) 2.413

Mode B(M)
Operation
control Frequency (MHz) 7.500
conditions
Focal depth (cm) 2.000

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CF(PW) mode (IEC 60601-2-37)

201.103 TABLE: Acoustic output reporting table -

TIS TIB

Index label MI Below At Below TIC

At surface
surface surface surface

Maximum index value 0.998 0.207 0.947 N/A

Index component 0.183 0.207 0.531 0.947

pr, α at zMI (MPa) 2.179

P (mW) 12.852 12.852 N/A

P1x1 (mW) 8.061 8.061

Zs (cm) 1.040
Acoustic
Parameters Zb (cm) 2.370

ZMI (cm) 2.400

Zpii, α (cm) 2.400

fawf (MHz) 4.770 4.770 4.770 N/A

prr (Hz) 4000.000

srr (Hz) N/A

npps N/A

Other Ipa, α at z pii, α (W/cm2) 295.394

information
Ispta, α at zpii, α or
(mW/cm2) 383.912
zsii, α

Ispta, α at zpii or zsii (mW/cm2) 846.544

pr at zpii (MPa) 3.236

Mode CF(PW)
Operation
control Frequency (MHz) 5.000
conditions
Focal depth (cm) 2.000

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B-mode (FDA)
201.7.9.3.101 TABLE: Acoustic output reporting table
TIS TIB
Index label MI At Below At Below TIC
surface surface surface surface
Global Maximum index value 0.125 0.0196 0.0226

Index component value

pr.3 (MPa) 0.34
W0 (mW) 0.55 0.55

P1x1 (mW)

Acoustic zsp (cm) 1.06

Parameters zbp (cm) 1.054
zMI (cm)
[email protected] (cm) 1.06

fc (MHz) 7.5 7.5 7.5

PRF (Hz) 10000
srr (Hz)
npps
Other
Ipa.a3 at MImax (W/cm2) 0.53
Information
Ispta.3 max (mW/cm2) 4.01

Ispta at z pii or zsii (mW/cm2)

pr@Pllmax (MPa) 1.228
Control 1
Control 2
Control 3
Operating
Control Control 4
conditions
Control 5

Control x

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CF-mode (FDA)
201.7.9.3.101 TABLE: Acoustic output reporting table
TIS TIB
Index label MI At Below At Below TIC
surface surface surface surface
Global Maximum index value 0.42 0.0275 0.041

Index component value

pr.3 (MPa) 0.95

W0 (mW) 1.16 1.16

P1x1 (mW)

Acoustic zsp (cm) 1.385

Parameters zbp (cm) 1.383

zMI (cm)
[email protected] (cm) 1.39
fc (MHz) 5 5 5
PRF (Hz) 5000
srr (Hz)
npps
Other
Ipa.a3 at MImax (W/cm2) 0.81
Information
Ispta.3 max (mW/cm2) 5.83
Ispta at z pii or zsii (mW/cm2)
pr@Pllmax (MPa) 1.204
Control 1
Control 2

Control 3
Operating
Control Control 4
conditions
Control 5

Control x

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10.5 Acoustic output and display accuracy

When you operate the SONON ultrasound device, the MI and TI values are displayed on the scan
screen.
For all SONON ultrasound devices, TI stands for either the TIS or TIB values. Your SONON
ultrasound device automatically selects an appropriate category based on its operation mode and the
application you choose. Because your SONON ultrasound device will present only one TI, it is
important that you choose the appropriate application for your diagnostic needs.

The maximum possible MI and Ispta when you operate the SONON ultrasound device are within the
limits set in Track 3 in the FDA 510(k) guidance of September 9, 2008 (MI<1.9 / Ispta <720 mW/cm2).

Display accuracy and acoustic measurement uncertainty

The accuracy of the output display parameters depends on measurement system precision and the
acoustic model used to calculate the parameters in the acoustic output of systems.
The measurement precision and overall accuracy of the measurements have been assessed by
determining both random and systematic uncertainties, and are given in a percentage at a 95%
confidence level.
Refer to the following table for the display accuracy and the measurement precision of the output
display.

Display accuracy
Parameter Uncertainty
Power ± 5.396%

Measurement accuracy
Parameter Accuracy
Length ± 7%
Ellipse ± 10%

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System controls affecting acoustic output

The operator controls which directly affect acoustic output are discussed in the “10.4 Acoustic output”
on page . Because these tables show the highest possible acoustic intensity for given modes, which
can be obtained only when the maximum combinations of control settings are selected, most settings
will result in a much lower output than the figures presented in the tables.
Note the following information related to acoustic ultrasound intensity and ultrasound exposure.

• The duration of an ultrasound exam is as important as the acoustic output, since patient
exposure to output is directly related to the exposure time.
• Better image quality yields faster clinical results, making it possible to complete the relevant
ultrasound examination in a shorter period of time. Any control that improves the quality of
the examination can help reduce patient exposure, even though it may not directly affect the
acoustic output.

Choosing an appropriate clinical application

Choosing an appropriate application for a particular ultrasound exam ensures acoustic output within
the limits which FDA guidelines provide for that application. Parameters will be automatically set in
such a way as to optimize performance for the selected application, to help reduce patient exposure
time.

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10.6 Specifications

Model name: SONON 300C

Specification
Dimensions (W x L x H) 3.07 x 8.62 x 1.49 in. (78 x 219 x 38 mm)
Weight (with battery) 13.75 oz (390 g)
Type: Rechargeable Li-ion Battery Pack
Battery
Capacity: 2600 mAh
Type: Soft AP
Frequency: 2.4 & 5 GHz Dual band WLAN
Wireless Communication
Modulation: IEEE 802.11g/n HT20 & 40
Output power: 9.2 dBm (e.i.r.p)
Mobile App OS: iOS/Android/Windows
Application General (abdomen)/OB/GY
Type BF Applied Part
Non-Continuous Operation (max 10 min with 10 min resting time)
IEC 60601-1
Internally Powered Equipment
Probe head: IPX7
Frequency: 3.5MHz
Ultrasound Module: Convex
Depth: Max. 9.45 in. (24 cm)
Firmware version: M1.01.XX
Software Version Software app version: M2.00.XX
※ “XX” means the internal usage number for minor changes and bug fixes

Model name: 300L

Specification
Dimensions (W x L x H) 3.07 x 8.62 x 1.49 (78 x 229 x 38 mm)
Weight (with battery) 13.05 oz (370g)
Type: Rechargeable Li-ion Battery Pack
Battery
Capacity: 2600 mAh
Type: Soft AP.
Wireless Communication
Frequency: 2.4 and 5 GHz Dual band Wi-Fi
Mobile App OS: iOS/Android/Windows
Musculoskeletal (MSK), Vascular,
Application
Small parts (breast, thyroid)
Type BF Applied Part
Non-Continuous Operation (Max 10 min with 10 min resting time)
IEC 60601-1
Internally Powered Equipment
Probe head: IPX7
Frequency: 5MHz/7.5MHz/10MHz
Ultrasound Module: Linear
Depth: Max. 3.93 in. (10 cm)
Firmware version: M1.01.XX
Software Version Software app version: M2.00.XX
※ “XX” means the internal usage number for minor changes and bug fixes

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Battery (rechargeable Li-ion battery pack)

Specification
Capacity 2,600 mAh (7.26V)
Guaranteed lifetime 6 months
Manufacturer MPLUS ELECTRONICS CO., LTD.
Model name MBP-2S1PSD26
Cell Type ICR18650
Dimensions (W x L x H) 1.5 x 2.77 x 0.8 in. (38.3 x 70.49 x 20.5 mm)
Safety PCM logic

NOTE
Contact the manufacturer or representative in your region for detailed information about purchasing
extra batteries.

Healcerion Co., Ltd. (Manufacturer)

501ho, 11, Gasan digital 2-ro, Geumcheon-gu, Seoul 08593 Republic of Korea
Homepage: www.healcerion.com
Tel: +(82) 2.6347.6328 / E-mail: [email protected]

PROVISION CONSULTING GROUP, INC. (US agent)

13925 CITY CENTER DR. STE 200
CHINO HILLS, CALIFORNIA, 91709, UNITED STATES
Tel: +(1) 909 -4933276 / E-Mail: [email protected]

Obelis S.A. (EC representative)

Bd. Général Wahis 53
1030 Brussels, BELGIUM
Tel: +(32) 2. 732.59.54 / Fax: +(32) 2.732.60.03 / E-Mail: [email protected]

Healcerion EMEA (UK representative)

Future Space UWE(North Entrance) Bristol, BS348RB
Tel: +(44) (0)7484712822 / E-Mail: [email protected]

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Glossary - Abbreviations
IEC terms Definitions

a Acoustic Attenuation Coefficient

Aaprt -12db Output Beam Area

CMI Normalizing Coefficient

Deq Equivalent Aperture Diameter

d-6 Pulse Beam Width

deq Equivalent Beam Diameter

awf Acoustic Working Frequency

lpa Pulse-Average Intensity

lpa,a Attenuated Pulse-Average Intensity

lpi Pulse-Intensity Integral

lpi,a Attenuated Pulse-Intensity Integral

lta(z) Temporal-Average Intensity

lta,a(z) Attenuated Temporal-Average Intensity

lzpta(z) Spatial-Peak Temporal-Average Intensity

lzpta,a(z) Attenuated Spatial-Peak Temporal-Average Intensity

MI Mechanical Index

P Output Power

Pa Attenuated Output Power

P1 Bounded Output Power

pi Pulse Pressure Squared Integral

pr Peak-Rarefactional Acoustic Pressure

Pra Attenuated Peak-Rarefactional Acoustic Pressure

prr Pulse Repetition Rate

TI Thermal Index

TIB Bone Thermal Index

TIC Cranial-Bone Thermal Index

TIS Soft-Tissue Thermal Index

td Pulse Duration / (same)

X, Y -12 dB Output Beam Dimensions / (same)

z Distance from the Source to a Specified Point / (same)

zbp Depth for TIB / Depth at which the relevant index is maximum

zbp Break-Point Depth / (same)

zs Depth for TIS / Depth at which the relevant index is maximum

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Technical information

FDA terms Definitions

MI Mechanical Index

TISscan Soft Tissue Thermal Index in auto-scanning mode

TISnon-scan Soft Tissue Thermal Index in non-auto-scanning mode

TIB Bone Thermal Index

TIC Cranial Thermal Index

Aaprt Area of the active aperture (square centimeters)

Derated peak rarefactional pressure associated with the transmit pattern giving rise to the
pr.3
value reported under MI (megapascals)

Ultrasonic power, except for TISscan, in which case it is the ultrasonic power passing
Wo
through a one-centimeter window (milliwatts)

W.3(z1) Derated ultrasonic power at axial distance z1 (milliwatts)

Derated spatial-peak temporal-average intensity at axial distance z1 (milliwatts per square

ITA.3(z1)
centimeter)

Axial distance corresponding to the location of max[min(W.3(z), ITA.3(z) x 1 cm2)], where

z1
z≥zbp (centimeters)

zbp
(centimeters)

zsp The axial distance at which TIB is a global maximum (i.e., zsp = zB.3) (centimeters).

The axial distance corresponding to the maximum of the derated spatial-peak pulse intensity
[email protected]
integral (megapascals).

the equivalent beam diameter as a function of axial distance z. It is equal to

deq(z) [(4/π)(Wo/ITA(z))]0.5 where ITA(z) is the temporal-average intensity as a function of z
(centimeters).

the center frequency (MHz). For MI, fc is the center frequency associated with the transmit
pattern giving rise to the global maximum reported value of MI. For TI, for combined modes
fc
involving transmit patterns of unequal center frequency, fc is defined as the overall range of
center frequencies of the respective transmit patterns.

Dim. of Aaprt the active aperture dimensions for the azimuthal (x) and elevational (y) planes (centimeters).

the pulse duration (microseconds) associated with the transmit pattern giving rise to the
PD
reported value of MI.

the pulse repetition frequency associated with the transmit pattern giving rise to the reported
PRF
value of MI (Hz).

the peak rarefactional pressure at the point where the free-field, spatial-peak pulse intensity
pr@PIImax integral is a maximum (megapascals). See “Acoustic output parameters” on page , entitled
“Measurement Methodology for Mechanical and Thermal Indices”.

the equivalent beam diameter at the point where the free-field, spatial-peak pulse intensity
deq@PIImax integral is a maximum (centimeters). See “Acoustic output parameters” on page , entitled
“Measurement Methodology for Mechanical and Thermal Indices”.

FL the focal length, or azimuthal (x) and elevational (y) lengths, if different (centimeters).

the derated pulse-average intensity at the point of global maximum reported MI (watts per
IPA.3@MImax
square centimeter).

146
 Appendix A

Appendix A Usage Agreement

USAGE AGREEMENT FOR PERSONAL INFORMATION
For the purpose of provision of basic services such as the HEALCERION application user registration,
password retrieval, etc., HEALCERION collects the following personal information, categorized into
patient information for the efficient management of user information and diagnosis information:

1. Collected Personal Information

• The range of personal information collected for registration of application users
– E-mail, Device Serial Number, Password, Name of Organization
• The range of patient information for management of diagnosis data:
– Name, Gender, Age, Height, Weight, Operator, Hospital, Image
• We do not ask for any sensitive personal information such as race, ideology, place of birth,
political inclination, criminal record, health condition, etc.
2. Purpose of Collection and Utilization of Personal Information
A. In Relation to Registration and Management of the HEALCERION Application, Users’ Personal
information may be collected for the purpose of identifying the HEALCERION application user,
confirmation of user qualifications, prevention of illegal usage of service, and password retrieval
service.
B. In Relation to Registration and Management of Patient Information Regarding Ultrasonic Image
Information Obtained by the HEALCERION device, Personal Information may be collected for
the purpose of discerning target patients or diagnosed persons of corresponding ultrasonic
image information and establishing reference data for future treatment.
C. Entered information shall not be collected and utilized for any other purpose such as marketing
and provision of product information, etc. The company, however, may contact users with
service-related notifications, troubleshooting, etc.
3. Duration of Retention and Utilization of Collected Personal Information
• The duration of retention and utilization of personal information is until the point of removal of
the HEALCERION application.
– The collected personal information is saved on the mobile device through the
HEALCERION application and deleted simultaneously with the removal of the
HEALCERION application.
THE SONON ULTRASOUND DEVICE USAGE AGREEMENT
Article 1 (Purpose)
• This Agreement is intended to regulate matters related to the usage of service of the
HEALCERION application, or the SONON X Ultrasound app (hereafter “SERVICE”), provided
by HEALCERION (hereafter ”COMPANY”).
Article 2 (Terms and Definitions)
• “Application” refers to the mobile application manufactured and managed by the COMPANY
with the purpose of aiding users who have registered a password to have access to ultrasonic
diagnosis by using the HEALCERION ultrasonic diagnosis instrument.
• “User” refers to a person who has registered information including personal information for the
purpose of utilization of the “SERVICE” provided by the “COMPANY” and is able to access an
ultrasonic diagnosis using the HEALCERION ultrasonic instrument through free utilization of
the “SERVICE” with the registered password.
• “HEALCERION ultrasonic diagnosis instrument” or “SONON ultrasound device” refers to the
medical instrument that visualizes the inside of the human body using ultrasonic waves and the
wireless mobile ultrasonic diagnosis instrument manufactured by the COMPANY.
• “Password” refers to combinations of letters and numbers that are set up by members for the
purpose of identification of members and protection of their rights and passwords and
registered to the SERVICE.

147
Appendix A

• “Personal Information” refers to information regarding a specific individual such as e-mail,

name of organization, etc. (Also includes any information that has the potential to be combined
with other information to make identification of a specific individual feasible).
• “Removal” refers to the action of removing the Application from the mobile device by the
“User”.
Article 3 (Manifestation, Description and Amendment of the Agreement)
• This agreement is valid only by being posted for users on the service screen or otherwise
notified.
• The COMPANY may amend contents of this agreement as long as there is no violation of laws
or other related ordinances regarding regulation of the agreement and shall notify any changes
through the procedure clarified in Article 1 above. However, significant matters regarding rights
and duties of the users shall be posted fifteen (15) days prior to implementation of amended
content.
• The COMPANY bears no responsibility for any loss or damage to Users due to their ignorance
of amended agreement.
• For matters not clarified in this agreement, all cases shall be considered according to the Act
on the Promotion of Information and Communication Network Use and Protection of
Information, other related laws and ordinances, or appropriate customs.
Article 4 (Content and Alteration of Service)
• The COMPANY may alter the contents of the SERVICE when it is unavoidable and shall issue
notification of such altered contents and implementation date seven (7) days in advance.
• The COMPANY is not responsible for compensation for any loss to the users due to alteration
of the SERVICE contents.
• However, it is NOT so if the COMPANY undertakes such alteration with bad intentions or
significant errors.
Article 5 (Termination of SERVICE)
• The COMPANY may temporarily suspend provision of the SERVICE due to causes of force
majeure such as repair, inspection, replacement or malfunction, interruption of communication,
etc...
• The COMPANY is not responsible for compensation for any loss to the users or any third party
caused by a temporary suspension of the SERVICE due to reasons clarified in Clause 1.
• However, it is NOT so if the COMPANY undertakes such alteration with bad intentions or
significant errors.
• (Usage Registration and Removal)
• The user shall apply for registration of usage of the HEALCERION application by inputting
personal information as required by the COMPANY and agreeing with this agreement.
• The user may at any time remove the HEALCERION application.
• However, upon removal of the HEALCERION application, all collected information is deleted
and the COMPANY is not responsible for any loss to the user or any third party caused by the
removal.
Article 6 (Personal Information Protection)
• The COMPANY conforms to all matters regulated by laws and ordinances such as the Act on
the Promotion of Information and Communication Network Use and Protection of Information,
etc...
• The COMPANY shall establish and post the “Privacy Policy” on the first SERVICE screen in
order to protect personal information of the members.
• In addition, further details of the “Privacy Policy” shall be available in a separate section.
Article 7 (Limitation of Responsibility Regarding the SERVICE)
• The COMPANY shall make its best effort to maintain the best possible security by avoiding
information leakage of diagnosis data of the users to any third party excluding doctors and
those with rights to such diagnosis data.
• However, the COMPANY is not responsible when such diagnosis data is revealed, exposed or
damaged due to the following reasons:
– Leakage of password due to inattention of the user
– When “deletion of diagnosis” function has been executed

148
 Appendix A

– When the HEALCERION application has been removed

– Due to other force majeure causes such as natural disaster
Article 8 (Responsibility of the COMPANY)
• The COMPANY shall not conduct any actions that violate related laws, this agreement, or
public morals and make its best effort to maintain its provision of stable and secure products
conforming to this agreement.
• The COMPANY shall establish a proper security system for protection of the personal
information (including credit information) of the members in order to allow them to safely utilize
the SERVICE and post and conform to the”Privacy Policy”.
• The COMPANY shall immediately work to rectify any complaint or opinion of the members
through appropriate procedures, when such complaint or opinion is considered objectively
reasonable. When an immediate resolution is not likely, however, the COMPANY shall notify
the member of the reason for such delay and the future settlement schedule.
Article 9 (Responsibility Regarding User ID and Password)
• All responsibility regarding user ID and password lies solely with the user and any civil/criminal
responsibility due to negligent management of the ID and password also lies solely with the
user.
• The user shall not allow any third party to have access to his or her user ID and password.
• When the user realizes that there has been a theft of his/her user ID and/or password or
becomes aware that they are being used by a third party, he/she shall immediately notify the
COMPANY and comply with any measures taken by the COMPANY.
• The user is fully responsible for any and all loss caused by nonfulfillment of the notification
cited above in Clause 3 or noncompliance with the COMPANY‘s measures.
Article 10 (Responsibility of the User)
• The user shall conform to any and all related laws and ordinances, regulations set by this
agreement, and usage guideline provided by the COMPANY and shall not conduct any
behavior that may interrupt other operations of the COMPANY.
• The user shall be prohibited from the following behavior regarding utilization of the SERVICE:
– Registration of false information at registration or alteration of the SERVICE
– Illegal usage of others’ information
– Transmitting or posting other information (computer programs, etc.) than that determined by the
COMPANY.
– Violation of any intellectual property rights such as copyright of the COMPANY or any other
third party.
– Any behavior that defames the COMPANY or another third party and interferes with business
operation.
– Revealing or posting any obscene or violent message, video, audio or any other information
that goes against public morals to the COMPANY.
– Utilizing the SERVICE for business purposes without the consent of the COMPANY.
– Any behavior that violates other related laws and ordinances or regulations of the COMPANY.
Article 11 (Copyright Ownership and Usage Limitation)
• All copyrights and intellectual property rights of the contents created by the COMPANY belong
to the COMPANY.
• The user may not use information that belongs to the COMPANY due to intellectual property
rights for business purposes or provide it to any third party through copying, transmitting,
publishing, distributing, broadcasting, etc., without the prior consent of the COMPANY.
• When utilizing any copyright that belongs to the user, the COMPANY shall notify the
corresponding user according to this agreement.
Article 12 (Arbitration)
• The COMPANY shall establish and manage a department for compensating for loss in order to
reflect and apply reasonable opinions or complaints reported by the members and compensate
for any loss.

149
Appendix A

• The COMPANY shall place priority on complaints and opinions of the members over other
matters. When an immediate resolution is not likely, however, the COMPANY shall
immediately notify the members of the reason for such delay and the future settlement
schedule.
Article 13 (Jurisdiction and Governing Law)
• The Law of the Republic of Korea shall be the governing law over interpretation of this
agreement and disputes between the COMPANY and its members.
• In case of any lawsuit arising from disputes between the COMPANY and its members
regarding this agreement and the SERVICE, the court of jurisdiction shall be determined
according to the Civil Procedure Code (CPC).

150
 Appendix B

Appendix B Medical Ultrasound Safety

This document is only available in English.
To contact the AIUM concerning their publications:
American Institute of Ultrasound in Medicine
14750 Sweitzer Lane, Suite 100
Laurel, Maryland
20707-5906
http://www.aium.org/
HEALCERION Co., Ltd.
501ho, 11, Gasan digital 2-ro, Geumcheon-gu, Seoul 08593 Republic of Korea
Tel: +(82) 2.6347.6328 E-mail: [email protected]