Asus LU700 Series User manual

ASUS Ultrasound Imaging System
LU700 Series
(LU700C, LU700L)
USER MAUNAL REV. A
LK_UI-LU700-01(E)

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Contents
About This Manual.....................................................................................................5
Disclaimer....................................................................................................... 6
Revision History............................................................................................. 7
Symbols.......................................................................................................... 8
Chapter 1 About ASUS Ultrasound Imaging System ............................................ 10
Ultrasound Gels............................................................................................ 11
LU700 Series Ultrasound Imaging System Description............................. 11
Battery Specification.................................................................................... 13
System Dimension....................................................................................... 13
Probe............................................................................................................. 13
RF energy spec............................................................................................. 15
Chapter 2 Product Usage........................................................................................ 16
Intended Use................................................................................................. 16
LU700C........................................................................................................ 16
LU700L......................................................................................................... 16
LU710C........................................................................................................ 16
LU710M........................................................................................................ 16
LU710PA...................................................................................................... 16
LU710E ........................................................................................................ 16
Contraindications and Warnings................................................................. 17
Contraindications ....................................................................................... 17
Warnings..................................................................................................... 18
Hardware....................................................................................................... 18
Purchases and Upgrades........................................................................... 18
Warranty...................................................................................................... 18
Disposal....................................................................................................... 19
Security......................................................................................................... 19
Information security ................................................................................... 19
Network Security ........................................................................................ 19
Confidentiality .............................................................................................. 19
Integrity constrains...................................................................................... 20

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Technical Features....................................................................................... 20
System Requirements.................................................................................. 21
Chapter 3 Safety ...................................................................................................... 22
Product Safety.............................................................................................. 22
Product Caution.......................................................................................... 22
Product Compatibility................................................................................. 23
Equipment Protection................................................................................. 23
Electrical Safety............................................................................................ 24
Battery Safety............................................................................................... 25
Thermal safety.............................................................................................. 26
Biological Safety .......................................................................................... 26
Latex............................................................................................................ 26
Bioeffects.................................................................................................... 26
ALARA Principles......................................................................................... 28
Acoustic Output Limits .............................................................................. 30
Applying ALARA......................................................................................... 30
Using System Controls to Implement ALARA.......................................... 30
Additional Considerations........................................................................... 31
Output Display............................................................................................ 31
Mechanical Index (MI) Display ................................................................... 32
Thermal Index (TI) Displays ....................................................................... 32
Controls Affecting the Indices................................................................... 33
Acoustics...................................................................................................... 34
Acoustic Output and Measurement........................................................... 34
Chapter 4 Device Maintenance ............................................................................... 36
Turning the Device ON and OFF ................................................................. 36
Transducer Care........................................................................................... 36
Cleaning & Disinfecting ............................................................................... 36
Maintenance ................................................................................................. 37
Chapter 5 Regarding Diagnostic Ultrasounds....................................................... 38
Interactions of Ultrasound with Matter ....................................................... 38
LU700 Series Device Operation................................................................... 38

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Overview of the Interface ........................................................................... 38
Status Lights............................................................................................... 39
Equipment description............................................................................... 40
Device Operation........................................................................................ 41
App Introduction......................................................................................... 42
Starting New Exams ................................................................................... 51
Chapter 6 References.............................................................................................. 58
Compliance Statement................................................................................. 58
Authorized Representative.......................................................................... 58
Product Classification.................................................................................. 58
Electromechanical Safety Standards Met................................................... 58
Product Serial Number................................................................................. 58
System Specifications ................................................................................. 59
Storage Limits .............................................................................................. 59
Standards...................................................................................................... 60
Acoustic ...................................................................................................... 60
Biocompatibility.......................................................................................... 60
Chemical...................................................................................................... 60
Labeling....................................................................................................... 60
Battery......................................................................................................... 60
Wireless....................................................................................................... 60
Waterproof .................................................................................................. 60
Safety Conformance..................................................................................... 61
Acoustic Output Tables ............................................................................... 63
ID Label......................................................................................................... 69
Guidance and Manufacture's Declaration................................................... 69
Electromagnetic Emissions....................................................................... 69
Electromagnetic immunity......................................................................... 72
Trouble Shooting........................................................................................ 75
Federal Communications Commission (FCC) Statement ........................ 76
FCC RF Radiation Exposure Statement.................................................... 76
Manufacturer’s address ............................................................................. 77

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ABOUT THIS MANUAL
This document contains the following information:
•About the ASUS Ultrasound Imaging System:
Describes the product, lists technical
specifications, and its intended use.
•A Quick Tour: Shows you how to get started and begin
scanning.
•Using the ASUS Ultrasound Imaging System:
Introduces you to the features and concepts,
helps you set up your system, and explains
the tasks you can perform.
•Cleaning & Disinfecting: Explains how to clean and
disinfect your System.
•Safety: Outlines important safety standards,
principles, and policies to follow when using
the product.
•References: Offers information such as
product standards, regulatory requirements,
terms and conditions, glossary of terms, and
acoustic output data.
Target Audience
This document is written for trained medical professionals who
operate and maintain user’s ASUS Ultrasound Imaging System. It
contains instructions and reference material pertaining to the usage
and maintenance of the product.

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Disclaimer
This disclaimer extends to all printed matter accompanying the ASUS Ultrasound Imaging
System.
This manual is licensed under the ASUSsoftware and maintenance agreement. All use o f this
manual m u st b e in compliance with the license. The information w i t h in these materials is
proprietary and confidential to ASUSTeK Computer Inc. (“ASUS“) and is provided for the sole use of
the individual or entity to whom it is addressed. Therefore, these materials must be held in the
strictest confidence. Without the prior written permission of ASUS, no part of this manual may
be copied, reproduced, republished, modified, sold, disclosed, or distributed. Unauthorized
copying or distribution of this manual, as well as an infringement of copyright, may impair the
ability of ASUS to provide updates and current information to users.
ASUS has taken care to ensure the accuracy of this document, however, revisions are not always
possible. ASUS assumes no liability for errors or omissions and information in this document
may be subject to change without notice. ASUS reserves the right to make changes to any
products herein without further notice to improve reliability, function, or design. ASUS reserves
the right to make improvements or changes in the products or programs described in this
document at any time.
These materials may contain third-party copyright and/or trademark materials, the use of which has
not always been specifically authorized by the intellectual property owner. All copyrights and/or
trademarks contained in these materials are the sole and exclusive property of their respective
owners.
The ASUS logo is a registered trademark and is the sole and exclusive property of ASUS.
All names used in ASUS (whether online, in print, or any other media) are fictitious and are used
herein for the purposes of example and demonstration on how to use the ASUS Ultrasound System.
Any similarity to real people is a coincidence.
Copyright © 2020 ASUS. All rights reserved. Published in Taiwan.

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Revision History
Revision
Date
User Manual Revision A
Initial release
2018-07-18
User Manual Revision B
-Add TI/MI related information
-Add company contact info
2018-08-16
User Manual Revision C
-Update the battery supplier
-Add LU710C/ LU710M/LU710PA/LU710E probe contents
-Update App introduction
2020-12-27

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Symbols
Symbols
Description/Function
Note
This icon indicates information material or helpful suggestions.
Caution
Indicates the need for the user to consult the instructions for use for
important cautionary information such as warnings, cautions and
precautions that cannot, for a variety of reasons, be presented on the
medical device itself.
Consult Operators Manual
Electrical protection. Insulated application with IEC60601-1 (Type BF
applied part)
Wi-Fi. This symbol means wireless communication
non-ionizing radiation
This way up. Indicates this correct upright position of the transport package.
Manufacturer. Indicates the medical device manufacturer, as defined in EU
Directives 90/385/EEC,93/42/EEC and 98/79/EC
Batch Code. Indicates the manufacturer's batch code so that the batch or
lot can be identified
Serial number. It means manufacture’s serial number and the medical
device can be identified.
Model name. It means manufacture’s Model name and the medical device
can be identified.
Indicates the Authorized representative in the European Community.
Fragile and handle carefully. Indicates a medical device that can be broken
or damaged if not handled carefully.

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Non-sterile
Keep dry. It means a medical device which needs to be protected from
moisture.
Indicates medical device that should not be used if the package has been
damaged or opened.
Atmospheric pressure limitation
Indoor use only. To identify electrical equipment designed primarily for
indoor use.
Requires separate collection for electrical and electronic equipment in
compliance with the Waste Electrical and Electronic Equipment (WEEE).
Directive. When accompanied by or, components of the device may contain
lead or mercury, respectively, which must be recycled or disposed of in
accordance with local, state, or federal laws. The backlight lamps in an LCD
system monitor contain mercury.
To identify electrical and electronic equipment that meets the Restriction
of Hazardous Substances (RoHS) Directive 2011/65/EU.
European Conformity. Conforms to European Council Directive
93/42/EEC.
Recyclable material. To indicate that the marked item or its material is
part of a recovery or recycling process.

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CHAPTER 1 ABOUT ASUS ULTRASOUND
IMAGING SYSTEM
Install, operate, and maintain this product according to the safety and operating procedures set
out in this manual, and only for its intended purpose. Always use the information in this
document alongside sound clinical judgment and best clinical procedures.
This product is subject to the law of the jurisdiction in which the product is used. Install, use, and
operate the product only in ways in adherence to applicable laws or regulations, and which are
in legal force.
Incorrect use of the product, or use for purposes other than those intended and expressly
stated by ASUS, may relieve ASUS or its agents from some or all responsibility for any resultant
noncompliance, damage, or injury.
Using portable and mobile radio-frequency (RF) communications equipment can affect the
operation of medical equipment.
Operating this system in the presence of inflammable gases or anesthetics can induce an
explosion.
Medical equipment should be installed and operated according to electromagnetic
compatibility (EMC) guidelines.
Responsibility for image quality and diagnosis is with users.
This product has demonstrated EMC compliance under conditions that included the use of
compliant peripheral devices. The use of compliant peripheral devices is important to reduce
the possibility of interference to radios, televisions, and other electronic devices.
•Never attempt to open a transducer or a transducer connector as this will void
the warranty.
•As probes are not delivered sterile before first use, it’s MANDATORY to clean and
disinfect probes to avoid infections or transmission of disease.
•Probes must be cleaned and disinfected before replacement or disposal.
•If a user loses his/her tablet/smart phone, the stored data is not recoverable.
•Do NOT touch patients with Android mobile device during use of the LU700 series.
•Comply with Operation conditions (i.e. max 30-min use with 10-min resting time.)
•As LU700 series is used in conjunction with personal mobile devices, users should
carefully manage patient data and key security information.

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•If the probe falls to the floor or on any other hard surface, CEASE further use.
Damage caused by impact to electrical insulation may increase the risk of
electrical shock due to damaged.
•Electrical leakage checks should be routinely performed by qualified hospital
personnel.
•This equipment is not intended for use in residential environments and may not
provide adequate protection to radio reception in such environments.
Ultrasound Gels
Ultrasound gel is a type of conductive medium that allows a close bond between the skin and the
probe or transducer, causing the waves to transmit directly to the underlying tissues and the areas
to be imaged. It is formulated to reduce static and act as a coupling agent.
Ultrasonic gel is usually composed of propylene glycol, water and occasionally a dye. The dye is
mostly for aesthetic purposes. The gel is usually clear and thick, and a slightly sticky. This means
the gel doesn't drip or run off after application to the skin. Post procedure, the gel can be wiped
off with ease.
•Do NOT use non-recommended gels (lubricants). These may damage the probe
and void the warranty.
•Ultrasound Gels should NOT contain any of the following ingredients, which have
the potential to damage the probe.
- Olive oil
- Methyl or ethyl parabens (para hydroxybenzoic acid)
- Dimethyl silicone
- Iodine
- Lotions
- Lanolin
- Aloe Vera
- Mineral oils
- Methanol, ethanol, isopropanol alcohol, or any other alcohol-based gels
•During the ultrasound Imaging diagnostic procedure, the examiner shall wear
"patient examination gloves". A patient examination gloves are disposable
devices intended for medical purposes and are worn on the examiner's hand or
fingers to prevent contamination between patient and examiner.
LU700 Series Ultrasound Imaging System Description
The LU700 Series Ultrasound Imaging System is a wireless, portable, software controlled, handheld
ultrasound system used to acquire and display hi-resolution and real-time ultrasound data through
a commercial off-the-shelf (COTS) Android mobile device.
I. The imaging system software runs as an app on a mobile device.
II. The imaging system software can be downloaded to a commercial off-the-
shelf (COTS) Android mobile device and utilizes an icon touch-based user
interface.

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BATTERY
Ultrasound
Beamforming &
Processing
Transducer Stack
User Interface (APP) for Display
Ultrasound Probe
Wi-Fi
Enable
User’s
Smart
phone
OR
Tablet
III. The imaging system comprises a series of wireless transducers employing Wi-
Fi-based technology to communicate with conventional tablet/smartphone
devices via Wi-Fi directly. This allows users to export ultrasound images and
display them across a range of portable personal devices.
IV. The imaging system houses a built-in battery, multichannel beamformer,
prescan converter and Wi-Fi components
The LU700 Series Ultrasound System included
Tx/Rx Analog
Interface

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Battery Specification
Item
Specification
Description
Rechargeable Li-ion Battery Pack
Capacity
6000mAh
Battery Life
300 discharge cycle
Manufacture
Shen Zhen Yu Xin Technology Co., Ltd.
Model
SZYX1036B7
Cell Type
Prismatic cell
Dimensions
120mm*36mm*10.5mm
Safety
UN38.3, EN IEC 62133
System Dimension
Item
Length(mm)
Width (mm)
Height(mm)
Weight(g)
LU700L
System
178
74
40
357
LU700C
System
187
74
40
388
LU710M
System
190
74
40
340
LU710C
System
187
74
40
388
LU710PA
System
194
74
40
350
LU710E
System
370
74
40
412
Probe
LU700L
-Array type: Linear
-Number of elements: 128
-Depth(cm): 6.0
-Frequency bandwidth (MHz): 5.0 –10.0
-Center Frequency: 7.5MHz
-B mode, M mode, CF mode, Color Doppler, PW Doppler

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LU700C
-Array type: Curvilinear
-Number of elements: 128
-Depth(cm): 18.0
-Frequency bandwidth (MHz): 2.0 –5.0
-Center Frequency: 3.5MHz
-Field of view: 60°
-B mode, M mode, CF mode, Color Doppler, PW Doppler
LU710C
-Array type: Curvilinear
-Number of elements: 128
-Depth(cm): 18.0
-Frequency bandwidth (MHz): 2.0-5.0
-Center Frequency: 3.2MHz
-Field of view: 60°
-B mode, M mode, CF mode, Color Doppler, Power Doppler
LU710M
-Array type: Micro convex
-Number of elements: 128
-Depth(cm): 12.0
-Frequency bandwidth (MHz): 4.0-8.5
-Center Frequency: 6.2MHz
-Field of view: 100°
-B mode, M mode, CF mode, Color Doppler, Power Doppler
LU710PA
-Array type: Phased array
-Number of elements: 64
-Depth(cm): 18.0
-Frequency bandwidth (MHz): 1.7-3.7
-Center Frequency: 2.7MHz
-Field of view: 90°
-B mode, M mode, CF mode, Color Doppler, Power Doppler
LU710E
-Array type: Endocavity
-Number of elements: 128
-Depth(cm): 15.0
-Frequency bandwidth (MHz): 4.0-8.5
-Center Frequency: 6.2MHz
-Field of view: 151°

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-B mode, M mode, CF mode, Color Doppler, Power Doppler
RF energy spec
-Tx frequency: 2412Mhz-2462Mhz
-TX modulation: DSSS/CCK/OFDM
-Tx Power:
18dbm @1DSSS
14.5dbm @54OFDM
-Rx frequency: 2412Mhz-2462Mhz
-Rx Sensitivity:
-95.7dbm @1DSSS
-74.0dbm @54OFDM

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CHAPTER 2 PRODUCT USAGE
Intended Use
The ASUS Ultrasound Imaging System is a software-based imaging system and accessories
intended for use by qualified physicians and healthcare professionals who has the ability to
conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow
analysis of the human body.
The device is intended for use in environments where healthcare is provided by trained
healthcare professionals, but not intended for use in emergency medical service, ambulance,
or aircraft.
The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power
Doppler mode, and the combined mode (B+M, B+CD, B+PWD).
LU700C
General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial),
peripheral vessel and OB/Gyn.
LU700L
General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional),
musculoskeletal (superficial) and peripheral vessel.
LU710C
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal
(conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710M
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal
(conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel.
LU710PA
Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric.
LU710E
Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), trans-rectal,
trans-vaginal, urology, gynecology.

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•The patient's diagnostic environment in circumstances may negatively
impact the system and the exam. For example: (1) Chemicals and gases in
the operating room. (2) Altitudes below -382 m or above 4000 m.
•Biological incompatibility may exist between the system materials used
and the biological tissues, cells, and body fluids of the patient/user, taking
account of the intended purpose of this system.
•Using this system in the patient environment may be unsafe if the following
conditions exist: (1) Extremes in humidity (RH<15% and RH>90%). (2)
Ambient temperatures that are excessively high (35°C / 95°F) or excessively
low (0°C / 32°F).
•Fragile patients, such as children and pregnant/nursing women, may be
more prone to the exposure of acoustic energy when this system is used
for prolonged periods.
•Do not use in a patient who would be harmed caused by applying
ultrasound (example: implanted pace-maker)
•The patients are not the users (not relevant) only used by related experts.
Users will be trained medical professionals (e.g., doctors, nurses,
technicians) with previous training in ultrasound. Images produced by this
system are transmitted wirelessly to the user’s smart device (tablet or
smart phone).
•Untrained/unqualified users purchasing and using this system may unable
to measure up quality images.
Contraindications and Warnings
Contraindications
(1) Do NOT use the ASUS Ultrasound Imaging System to do following situations then result in the
produce images with inaccurate results:
- Patients who have had surgery, which may have changed the composition of the examining
tissue, as this could skew or alter the measured density.
- Patients whose bodies contain foreign artifacts (for example, implants), in the examining
tissue.
- Intra-operative use (e.g., defined as introducing a System into a surgical incision or burr hole).
- Ophthalmic use or any use causing the acoustic beam to pass through the eye.
- At the scene of an emergency outside of a professional healthcare facility.
- During transportation of a patient to a professional healthcare facility, or between
professional healthcare facilities.
- Try imaging on an open wound.

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-Clinically used in secondary areas (including, but not limited to, surgery, rectum, vaginal,
etc.). It’s should be confirmed that the probe used is approved by the competent authorities’
aseptic probe sheath cover.
Warnings
(1) DO NOT immerse the probe into any liquid beyond the immersion level. Never immerse
the probe connector into any liquid.
(2) Do NOT use in a patient who would be harmed caused by applying ultrasound.
(3) DO NOT drop the probe or subject them to other types of mechanical shock or impact.
Degraded performance or damage such as cracks or chips in the housing may result.
(4) Do NOT modify this device without authorization of the ASUS.
(5) Do NOT use the probe with high frequency surgical equipment. Doing so may damage
the equipment.
(6) Do Not use the product close to strong electromagnetic field, electromagnetic wave and
magnetic environment. There is possibility of measurement errors or damage to the
product.
(7) When the device LU700 is charged with a mobile charging power supply, do NOT use it
to work for diagnostic.
(8) Do not allow the transducer to contact the patient if the temperature of the transducer is
higher than 43°C (109°F).
(9) Do not operate this system in the presence of flammable gases or anesthetics. Explosion
can result.
(10) Do not use if the face is cracked, chipped, or torn; the housing is damaged; or the cable
is abraded. Electric shock can result.
(11) Do Not charge the battery near a fire or heater.
(12) Never attempt to open a transducer or a transducer connector.
All the contraindications and warning are well concerned by following the regulation of EN ISO
14971:2012 with related report.
Hardware
Purchases and Upgrades
•The equipment has a lifetime of 300 battery charging cycle.
•To order additional supplies and accessories, go to www.asus.com and contact Leltek.
Warranty
•This equipment includes a one-year warranty. To purchase extended warranty
programs, go to www.asus.com and contact Leltek.

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Disposal
•ASUSsupports and protects the natural environment. This equipment is designed and
manufactured according to environmental protection guidelines.
Improper disposal of this equipment (e.g. if the battery is no longer functioning or the
scanner has exceeded its shelf life) can add hazardous materials to landfills. For
information on the proper disposal of this equipment or any of its parts, please contact
the manufacturer or an authorized disposal company to decommission your
equipment in accordance with local regulations.
Security
Information security
•When using ASUSUltrasound App, it is the user's responsibility to protect their own
security credentials (e.g. passwords) and the patient's persona information (e.g. name
and so on).
Network Security
•We recommend that user secures this network using WPA (Wi-Fi Protected Access).
User will be trained medical professionals (e.g., doctors, nurses, technicians) with
previous training in ultrasound. Images produced by the probe are transmitted
wirelessly to the user’s smart device (tablet or smart phone).。
As following actions could present new risks to patients, operators, and third parties.
It is your organization's responsibility to identify, analyze, evaluate, and control these
risks:
•Changing network configurations.
•Connecting to additional networks or disconnecting from existing networks.
•Upgrading to new equipment or updating existing equipment.
Confidentiality
The confidential information is assured as follows:
•The scanner contains no patient-identifiable information.
•When the scanner connects to a wireless network.
•The data transferred between the smart device and the
ASUSUltrasound App is encrypted.
•Image data contains no patient or user identifiable information and is
transmitted in unencrypted form. If you want this data encrypted, connect
to a:

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* Wi-Fi network where only trusted parties are permitted. The Wi-Fi network
encrypts all image data sent from other Wi-Fi networks.
* Wi-Fi Direct network. The Wi-Fi Direct network encrypts all image data, and
because no other users are on the Wi-Fi Direct network, the image data is
confidential.
Integrity constrains
Integrity of the data transmitted between the smart device and the ASUSUltrasound App is
assured as follows:
•Authenticated encryption prevents malicious users from intercepting and modifying data.
•Integrity checks ensure completion and validity of data received. If any data is
incomplete or invalid, it is discarded.
•TCP channels used over Wi-Fi ensures that data is delivered correctly. For
transmitting image data, a TCP channel is used.
Technical Features
There are some of the technical aspects of the system as following list:
•Wi-Fi 802.11b/g wireless connect
-Receive frequency and/or band and bandwidth of receiving section.
-Transmit frequency and/or band, modulation, and ERP
•USB 3.0, Micro B connector as output port
•ASUShigh performance computing technology of FPGA
•ASUSunique technology “Ultra Image Block Algorithm” (UIBA) solution for B
mode, Color mode, M mode, Power Doppler and PW Doppler block image
•High frame rate
•High contrast
•High resolution
•Tissue Harmonic Imaging
•Support Image Mode
•B mode
•Color Doppler
•M mode
•PW Doppler
•Power Doppler