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.