BenQ HI300 User manual

H1300
Diagnostic Ultrasound System
Operating Instructions

Table of Contents
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
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Table of Contents
Chapter 1 Read This First 1
Copyright ..................................................................................................................................................... 1
Disclaimer .................................................................................................................................................... 1
Contact Information .......................................................................................................................................... 2
Contraindication................................................................................................................................................ 2
Intended Audience............................................................................................................................................ 2
Intended Use .................................................................................................................................................... 2
Warnings .......................................................................................................................................................... 3
WEEE...............................................................................................................................................................4
Discarding the Tablet and the Battery Pack...................................................................................................... 4
Equipment List.................................................................................................................................................. 4
Conventions...................................................................................................................................................... 5
System Warranty .............................................................................................................................................. 5
Chapter 2 Safety Information 6
Symbols............................................................................................................................................................ 9
System Label Icons ..................................................................................................................................... 9
Shipping Label Icons ................................................................................................................................. 11
System Button ........................................................................................................................................... 11
Electrical Safety.............................................................................................................................................. 12
Battery Usage/Disposal ............................................................................................................................. 13
Electrical Fast Transients (EFT) ................................................................................................................ 13
Conducted Susceptibility (CS) ................................................................................................................... 13
Electrostatic Discharge Precautions (ESD) ............................................................................................... 14
Electromagnetic Interference (EMI) ........................................................................................................... 14
Surges to AC Power Mains........................................................................................................................ 20
Mechanical Safety .......................................................................................................................................... 20
Equipment Protection ..................................................................................................................................... 20
RF Safety........................................................................................................................................................ 21
Biological Safety............................................................................................................................................. 21
Heating ...................................................................................................................................................... 22
Cavitation................................................................................................................................................... 22
Safe Scanning Guideline ........................................................................................................................... 22
Operator Safety ......................................................................................................................................... 23
Infection Control......................................................................................................................................... 23
Disposable Drape ...................................................................................................................................... 23
Waterproof and Dustproof Ratings ................................................................................................................. 24
Understanding the MI/TI Display .................................................................................................................... 24
Operator Control Features......................................................................................................................... 25
Transducer Surface Temperature Rise........................................................................................................... 26

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Chapter 3 Overview 27
System Capabilities........................................................................................................................................ 28
Imaging ...................................................................................................................................................... 28
Transducer Types ...................................................................................................................................... 28
Measurements ........................................................................................................................................... 28
Calculations ............................................................................................................................................... 28
Image Acquisition and Review................................................................................................................... 29
Patient Data Protection.............................................................................................................................. 29
Connectivity ............................................................................................................................................... 29
System Overview............................................................................................................................................ 30
Front and Side Views................................................................................................................................. 30
Rear and Top/Bottom Views ...................................................................................................................... 31
Transducer Overview ..................................................................................................................................... 32
Clinical Applications and Transducers ....................................................................................................... 32
Indications for Use and Supporting Transducer ............................................................................................. 32
Chapter 4 Preparing the System 34
Inserting the USB Flash Drive ........................................................................................................................ 35
Using the System Stand................................................................................................................................. 35
Inserting the Battery Pack .............................................................................................................................. 36
Charging the Battery Pack.............................................................................................................................. 38
Through the System .................................................................................................................................. 38
Through the Battery Charger ..................................................................................................................... 39
Connecting the Transducer ............................................................................................................................ 40
Removing the Transducer .............................................................................................................................. 41
Outputting the System Display to an HDMI-Enabled TV or Monitor............................................................... 41
Chapter 5 Using the System 42
Turning On/Off the System............................................................................................................................. 43
Logging Into the System................................................................................................................................. 43
Creating a New Administrator Account ...................................................................................................... 43
Adding a New User Account ...................................................................................................................... 44
Switching Users ......................................................................................................................................... 44
Launching the Main Screen............................................................................................................................ 44
Setting the System Time and Date................................................................................................................. 45
Controlling the System ................................................................................................................................... 46
Gestures for Controlling the Real-time, Frozen and Review Imaging Screens ......................................... 47
Gestures for Controlling the Real-time and Frozen Imaging Screens ....................................................... 47
Gestures for Controlling the Real-time Imaging Screen ............................................................................ 47
Gestures for Controlling the Frozen Imaging Screen ................................................................................ 48
Gestures for Controlling the Review Imaging Screen................................................................................ 48
Setting the System Language ........................................................................................................................ 48
Identifying the Main Screen Layout ................................................................................................................ 49
System Menu Screen ................................................................................................................................ 49
Imaging Screen (Real-time)....................................................................................................................... 50

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Imaging Screen (Frozen) ........................................................................................................................... 52
Quick Setup ............................................................................................................................................... 53
Virtual Keyboard ........................................................................................................................................ 54
Scan Properties Display ............................................................................................................................ 54
Switching the Control Panel Pages ................................................................................................................ 55
Managing the System Power.......................................................................................................................... 55
Battery Status Icons................................................................................................................................... 56
Sleep Mode................................................................................................................................................ 56
Managing Disk Space................................................................................................................................ 56
Network Configuration.................................................................................................................................... 57
Connecting the System to the Wireless Network....................................................................................... 57
Connecting the System to a Bluetooth Device ............................................................................................... 57
Unpair a Bluetooth Device ......................................................................................................................... 58
DICOM Configuration ..................................................................................................................................... 58
Adding Servers .......................................................................................................................................... 58
Local Host.................................................................................................................................................. 59
Managing Outgoing Queue........................................................................................................................ 59
Setting SCP Data Encoding Type .............................................................................................................. 59
Setting Image Compression ...................................................................................................................... 59
Casting the System Screen to a Remote Display........................................................................................... 60
Chapter 6 Performing an Exam 61
Starting a New Exam...................................................................................................................................... 62
Adding a New Patient..................................................................................................................................... 62
Updating Patient Information ..................................................................................................................... 63
Loading a Worklist.......................................................................................................................................... 63
Selecting a Preset .......................................................................................................................................... 64
Customizing a Preset................................................................................................................................. 64
Modifying a Preset ..................................................................................................................................... 64
Managing Presets...................................................................................................................................... 64
Exporting and Importing Customized Presets ........................................................................................... 65
Setting the Transducer Orientation................................................................................................................. 65
Selecting a Scan Mode................................................................................................................................... 65
Adjusting the Displayed Image....................................................................................................................... 65
Enlarging an Area of the Image ................................................................................................................. 65
Splitting the Imaging Screen........................................................................................................................... 66
Freezing an Image.......................................................................................................................................... 68
Adding Annotations......................................................................................................................................... 68
Arrow ......................................................................................................................................................... 69
Annot ......................................................................................................................................................... 69
Label .......................................................................................................................................................... 69
Body Mark.................................................................................................................................................. 70
Adding Measurements.................................................................................................................................... 70
Measuring in B/Color/Power Modes .......................................................................................................... 71
Measuring in M-mode ................................................................................................................................ 73
Measuring in Spectral Doppler Mode ........................................................................................................ 74

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Saving and Printing the Image ....................................................................................................................... 75
Saving a Cine Loop ................................................................................................................................... 75
Saving an Image........................................................................................................................................ 75
Printing an Image....................................................................................................................................... 75
Reviewing the Image...................................................................................................................................... 75
Performing Multiple Selections .................................................................................................................. 76
Comparing Images .................................................................................................................................... 77
Generating a Report....................................................................................................................................... 77
Exporting the Exam ........................................................................................................................................ 78
Managing the Exam History ........................................................................................................................... 79
Resuming an Exam ................................................................................................................................... 79
Starting a New Exam ................................................................................................................................. 79
Finishing Exam .......................................................................................................................................... 79
Deleting Exam ........................................................................................................................................... 80
Exporting Exam ......................................................................................................................................... 80
Importing Exams........................................................................................................................................ 80
Ending the Exam ............................................................................................................................................ 80
Chapter 7 Using Image Controls 81
B mode Image Controls.................................................................................................................................. 82
Overview.................................................................................................................................................... 82
Adjusting Gain ........................................................................................................................................... 82
Adjusting Frequency .................................................................................................................................. 82
Adjusting Time Gain Compensation (TGC) ............................................................................................... 82
Adjusting the Scan Depth .......................................................................................................................... 83
Adjusting the Focus Depth, Focal Zone and Focal Span .......................................................................... 83
Adjusting Dynamic Range ......................................................................................................................... 83
Using Tissue Harmonic Imaging (THI)....................................................................................................... 83
Adjusting Persistence ................................................................................................................................ 83
Adjusting Sharpness and Smoothing......................................................................................................... 83
Adjusting Gray Map ................................................................................................................................... 83
Adjusting Chroma Map .............................................................................................................................. 84
Adjusting Steer Angle ................................................................................................................................ 84
Adjusting the Sector Width and Position.................................................................................................... 84
Adjusting Power......................................................................................................................................... 84
Using Trapezoidal Imaging ........................................................................................................................ 84
Adjusting Density ....................................................................................................................................... 84
Using Compound Imaging ......................................................................................................................... 84
Using Central Line ..................................................................................................................................... 84
Using ENV (Enhanced Needle Visualization) ............................................................................................ 85
Using Quad View ....................................................................................................................................... 85
Color/Power Mode Image Controls ................................................................................................................ 86
Overview.................................................................................................................................................... 86
Adjusting Velocity Range Scale ................................................................................................................. 87
Inverting the Color Display......................................................................................................................... 87
Using Directional Power ............................................................................................................................ 87
Selecting a Color Map ............................................................................................................................... 87
Adjusting Wall Filter ................................................................................................................................... 88

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Applying the Smoothing Filter.................................................................................................................... 88
Adjusting the Color Priority ........................................................................................................................ 88
M-mode Image Controls................................................................................................................................. 88
Overview.................................................................................................................................................... 88
Using Steer M ............................................................................................................................................ 89
Adjusting Sweep Speed............................................................................................................................. 89
Selecting M Process .................................................................................................................................. 89
Inverting the M-mode Trace Display .......................................................................................................... 89
Spectral Doppler Mode Image Controls ......................................................................................................... 89
Overview.................................................................................................................................................... 89
Adjusting Baseline ..................................................................................................................................... 90
Adjusting Sample Volume (SV) Size.......................................................................................................... 90
Adjusting Correction Angle ........................................................................................................................ 91
Updating the 2D Display ............................................................................................................................ 91
Chapter 8 System Customization 92
Customizing Your System............................................................................................................................... 93
General ...................................................................................................................................................... 93
Preset ........................................................................................................................................................ 93
Patient........................................................................................................................................................ 93
Exam.......................................................................................................................................................... 93
Workflow .................................................................................................................................................... 94
Imaging ...................................................................................................................................................... 95
Annotation.................................................................................................................................................. 95
BDMK (Body Mark).................................................................................................................................... 95
Measurement............................................................................................................................................. 95
Report ........................................................................................................................................................ 96
DICOM....................................................................................................................................................... 96
Networking................................................................................................................................................. 96
Print ........................................................................................................................................................... 96
Servicing Your System.................................................................................................................................... 97
Reinstalling Software ................................................................................................................................. 97
Checking the Software Version.................................................................................................................. 97
Checking the Tablet’s Serial Number......................................................................................................... 97
Checking the License Status ..................................................................................................................... 98
Backing Up System Settings and/or Patient Data ..................................................................................... 98
Restoring System Settings and/or Patient Data ........................................................................................ 98
Resetting Your System .............................................................................................................................. 99
Testing the System .................................................................................................................................... 99
Exporting System Logs.............................................................................................................................. 99
Exporting Keystroke Logs.......................................................................................................................... 99
About ......................................................................................................................................................... 99
Configuring Security Policies........................................................................................................................ 100
Security Policies ...................................................................................................................................... 100
Chapter 9 Transducer and System Maintenance 101
Transducer Maintenance.............................................................................................................................. 102

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Transducer Storage...................................................................................................................................... 102
Storage for Transport............................................................................................................................... 102
Daily and Long-Term Storage .................................................................................................................. 102
Transducer Care........................................................................................................................................... 103
Transducer Care and Operator Safety..................................................................................................... 103
Inspecting the Transducer ............................................................................................................................ 104
Transducer Care Method.............................................................................................................................. 104
Cleaning and Disinfecting Transducers........................................................................................................ 105
Cleaning Instructions ............................................................................................................................... 105
Ultrasound Transmission Gels...................................................................................................................... 106
Compatible Disinfectants and Cleaning Solutions........................................................................................ 106
System Maintenance.................................................................................................................................... 107
Inspecting the System ............................................................................................................................. 107
Cleaning the System................................................................................................................................ 107
Cleaning the System/Surfaces/Transducer holder .................................................................................. 107
Cleaning the Power Adapter .................................................................................................................... 109
Chapter 10 Troubleshooting 110
Chapter 11 Appendices 113
Appendix A: Specifications ........................................................................................................................... 114
System..................................................................................................................................................... 114
Transducer............................................................................................................................................... 115
Adapter .................................................................................................................................................... 115
Battery ..................................................................................................................................................... 116
Appendix B: Connectivity and Security......................................................................................................... 116
Introduction .............................................................................................................................................. 116
Specifications........................................................................................................................................... 116
Information Flow ...................................................................................................................................... 117
Appendix C: System Acoustic Output Default Tables ................................................................................... 118
Appendix D: Acoustic Output Reporting Tables for Track 3.......................................................................... 122
Definition of Terms Used in Acoustic Output Tables ................................................................................ 123
Acoustic Output Tables for H1300 Transducers....................................................................................... 125
Appendix E: European Commission (CE) Statement................................................................................... 144
European Union Regulatory Notice ......................................................................................................... 144

CHAPTER
1
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
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Chapter 1 Read This First
Copyright
Copyright 2020 Qisda Corporation. All rights reserved. No part of this
publication may be reproduced, transmitted, transcribed, stored in a
retrieval system or translated into any language or computer language,
in any form or by any means, electronic, mechanical, magnetic, optical,
chemical, manual or otherwise, without the prior written permission of
Qisda Corporation.
All other logos, products, or company names mentioned in this Operating
Instructions may be the registered trademarks or copyrights of their
respective companies, and are used for informational purposes only.
Disclaimer
Qisda Corporation makes no representations or warranties, either
expressed or implied, with respect to the contents hereof and specifically
disclaims any warranties, merchantability or fitness for any particular
purpose. Further, Qisda Corporation reserves the right to revise this
publication and to make changes from time to time in the contents hereof
without the obligation to notify any person of such revision or changes.
This Operating Instructions aims to provide the most updated and
accurate information to customers, and thus all contents may be
modified from time to time without prior notice.
This chapter covers the following topics:
 “Contact Information” on page 2
 “Contraindication” on page 2
 “Intended Audience” on page 2
 “Intended Use” on page 2
 “Warnings” on page 3
 “WEEE” on page 4
 “Discarding the Tablet and the Battery Pack” on page 4
 “Equipment List” on page 4
 “Conventions” on page 5
 “System Warranty” on page 5

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BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
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The H1300 Diagnostic Ultrasound System (hereinafter called “system”) is an easy-to-use, portable
ultrasound imaging instrument intended for use by a qualified operator for ultrasound evaluation and clinical
analysis.
The Operating Instructions provides important procedures and information on how to operate the system
and service the system correctly and safely. Before attempting to operate the system, read this Operating
Instructions and strictly observe all warnings and cautions. Pay extra attention to the information from
“Chapter 2 Safety Information” on page 6.
Contact Information
Distributor: BenQ Medical Technology Corporation
Address: 7th floor, No.46, Zhou-Z Street, Nei-Hu, Taipei 114, Taiwan
Website: www.BenQMedicalTech.com
Customer Service e-mail: [e-mail]
Customer Service Hotline:
Tel: [phone]
Fax: [phone]
Manufacturer: Qisda Corporation
Address: No.157, Shan-Ying Road, Shan-Ting Li, Gueishan Dist., Taoyuan City, Taiwan, R.O.C.
Production site: Qisda Corporation Shuang-Shing 2 Factory
Address: 4F, No.159, Shan-Ying Road, Shan-Ting Li, Gueishan Dist., Taoyuan City, Taiwan, R.O.C.
EU Representative
MedNet EC-REP GmbH
Borkstrasse 10, 48163 Muenster, Germany
Contraindication
The system is not intended for ophthalmic use. Never use the system for eye scanning.
Intended Audience
This document is intended for sonographers, physicians, and biomedical engineers who operate
and maintain the system and are familiar with ultrasound techniques.
Intended Use
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified
physician for ultrasound evaluation and clinical analysis. It is indicated for diagnostic ultrasound
imaging in the following non-intrusive applications: Abdomen, Cardiology, Gynecology, Obstetric,
Breast, Thyroid, Musculoskeletal, Vascular (Carotid, Venous, Arterial), Nerve, Renal and Urology.
The clinical environments where the system can be used include physician offices, clinics, hospitals,
and clinical point-of-care for diagnosis of patients except environments where the intensity of
electromagnetic disturbances is high.

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BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
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The system is intended to be installed, used, and operated only in accordance with the safety
procedures and operating instructions given in the system user information, and only for the
purposes for which it was designed.
The system should only be operated by someone who has received proper training in the use and
operation of an ultrasound system. This system produces images derived from sound echoes; those
images must be interpreted by a qualified medical professional. This system in no way interprets
these images or provides a medical diagnosis of the patient being examined.
WARNINGS
 Do not use the system for purposes other than those intended and expressly stated
above. Do not misuse the system, and do not use or operate the system incorrectly.
 Do not use the system in ophthalmology applications.
 Installation, use, and operation of the system are subject to the law in the jurisdictions
in which it is used. Install, use, and operate the system only in such ways that do not
conflict with applicable laws or regulations, which have the force of law. Use of the
system for purposes other than those intended and expressly stated here, as well as
incorrect use or operation, may relieve us or our agents from all or some responsibilities
for resultant noncompliance, damage, or injury.
 System users are responsible for image quality and diagnosis. Inspect the data that is
being used for the analysis and diagnosis, and ensure that the data is sufficient both
spatially and temporally for the measurement approach being used.
Warnings
Before using the system, read the following warnings and “Chapter 2 Safety Information” on
page 6.
 Do not attempt to disassemble or modify the system. There are no user serviceable parts
inside this system. Necessary modifications must be made only by the manufacturer or
its designated agents.
 Do not allow any liquid to get inside this system. Water and moisture may cause short-
circuit to the electronic components and lead to malfunctions.
 Do not drop or apply shock/vibration to this system. Strong impacts may damage the
components inside.
 Do not cut, bend, modify, place heavy objects, or step on the cable of the power adapter.
Otherwise the external insulation may be damaged and result in short-circuit or fire.
 Do not use this system near strong electromagnetic sources, such as a microwave oven.
The electromagnetic interference may cause this system to malfunction.
 To avoid electrical shock, use only supplied power cords and connect only to properly
grounded wall outlets.
 The system should not be used adjacent to or stacked with other equipment. If adjacent
or stacked use is necessary, the system should be observed to verify normal operation in
the configuration in which it will be used.

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BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
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WEEE
Disposal of Waste Electrical and Electronic Equipment and/or Battery by users in private
households in the European Union.
This symbol on the product or on the packaging indicates that this can not be disposed
of as household waste. You must dispose of your waste equipment and/or battery
by handling it over to the applicable take-back scheme for the recycling of electrical
and electronic equipment and/or battery. For more information about recycling of this
equipment and/or battery, please contact your city office, the shop where you purchased
the equipment or your household waste disposal service. The recycling of materials
will help to conserve natural resources and ensure that it is recycled in a manner that
protects human health and environment.
Recycling information: See http://www.benq.com/support/recycle for details.
Discarding the Tablet and the Battery Pack
The tablet and the battery pack should be discarded in an environmentally safe manner. Properly
dispose of batteries according to local regulations.
WARNINGS
 Do not disassemble, puncture, or incinerate batteries. Be careful not to short the battery
terminals, because that could result in a fire hazard.
 Use caution when handling, using, and testing the batteries. Do not short circuit,
crush, drop, mutilate, puncture, apply reverse polarity, expose to high temperatures, or
disassemble. Misuse or abuse could cause physical injury.
 If electrolyte leakage occurs, wash your skin with large amounts of water to prevent skin
irritation and inflammation.
Equipment List
Check the sales package for the following items. If any item is missing or damaged, contact your
place of purchase immediately.
 Diagnostic Ultrasound System
 Medical grade AC/DC power adapter
 Power cord
 Battery pack
 HDMI cable (Type-C to Type-A)
 Two USB flash drives (Type C) containing the PDF file of the Operating Instructions (this
document) and the system software
 One or more transducers
 External battery charger (charges 2 battery packs simultaneously)
 Warranty Card
WARNINGS
 AC plug types vary by country/region.

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BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
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 Using accessories, transducers, or power supply units other than those specified may
cause the warranty to void and result in increased emissions, decreased EMI immunity of
the system, or even damages to the system and personal injuries.
 Use of other accessories results in non-compliance.
Conventions
The system uses certain conventions throughout the interface to make it easy for you to learn and
use:
 See “Controlling the System” on page 46 to control the system using gestures.
 To adjust the parameter value of a function, touch the plus/minus buttons (+/-).
 To type texts into a text field, touch the field and use the virtual keyboard that appears. You can
also use a supported USB or Bluetooth keyboard for entering texts.
 To display a list, touch the down arrow . To display the options, touch the Menu icon .
 To select/deselect an item or to enable/disable a function:
 Touch the checkbox. For example, check the exam ; uncheck the exam .
 Touch the two-state toggle switch. For example, switch on Wi-Fi ; switch off Wi-Fi .
The Operating Instructions uses certain conventions throughout the book to make it easier to find
the information you need.
 Control names and menu items or titles are spelled as they are on the system, and they appear
in bold text.
 The on-screen menu steps needed to perform a function are shown in a condensed form. For
example, touch > Settings > DICOM.
 Refer to the following graphic symbols to alert you to important information:
This icon marks NOTES; useful tips or additional information that help you get better use
of your product.
This icon marks CAUTIONS; notices describing actions or conditions that may damage
your product or cause injury, and consequently void your warranty or service contract or
lose the patient or system data.
This icon marks WARNINGS; instructions that must be followed. Failure to observe can
cause damages to your product, or result in personal injuries, or even death.
System Warranty
The warranty is void if unauthorized personnel perform service or maintenance on the system.
To ensure correct system performance and to obtain warranty service, please contact technical
support. For more information, see “Contact Information” on page 2.

CHAPTER
2
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
6
Chapter 2 Safety Information
This chapter covers the following topics:
 "Symbols" on page 9
 "Electrical Safety" on page 12
 "Mechanical Safety" on page 20
 "Equipment Protection" on page 20
 "RF Safety" on page 21
 "Biological Safety" on page 21
 "Waterproof and Dustproof Ratings" on page 24
 "Understanding the MI/TI Display" on page 24
 "Transducer Surface Temperature Rise" on page 26

Safety Information
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
7
WARNING
Follow the procedures carefully and ensure that the power/electrical/environmental
requirements are satisfied. Failure to observe the instructions or disregard the warnings
may result in damages to the system, personal injury, or even death of the operator or the
patient.
Observe the following precautions carefully.
 This system complies with Type BF general equipment and the EN60601-1 standard,
suitable for continuous operation when connected as a system to a medical grade AC/DC
power adapter or operated from the tablet battery.
 Use only medical grade peripherals in the patient environment.
 Do not block or otherwise obstruct access to the AC plug at the wall. Operators must be
able to quickly unplug the power cord at the wall in case of emergency.
 The system should only be used in a medical facility under the supervision of a trained
physician.
 Only an authorized service technician should perform maintenance.
 Be extremely cautious when placing or moving the system.
 Always position the system on a stable surface where it cannot fall on the patient.
 Do not lift the system by the power cable or the transducer. If either disconnects, the
system could fall on the patient.
 This system has been fully adjusted and tested prior to shipment from the factory.
Unauthorized modifications will void your warranty.
 If this system or the transducer connected displays any signs of malfunction, turn off the
system immediately, disconnect it from the wall outlet, then contact technical support (See
“Contact Information” on page 2).
 Do not use a power adapter other than the one supplied with the system. Connecting
the system to an unknown power adapter is very dangerous and may lead to fire or
explosion.
 Using cables, transducers, or accessories other than those specified for use with the
system may result in increased emissions or decreased immunity of the system.
 The power cord of the system should only be connected to a grounded power socket.
 Do not connect USB peripherals with an extended USB cable. Extended connection may
cause unexpected usage fault.
 Only devices that comply with the EN60601-1 standard, either electronically or
mechanically, can be connected to this system. Recheck the leakage current and other
safety performance indices of the entire system to avoid potential system damage caused
by leakage from a current superposition.
CAUTIONS
 Using accessories, transducers, peripherals, or cables not supplied with the system or
recommended by the distributor can affect the system in the form of increased emissions
or decreased immunity to external EMI/EMC occurrences. Non-specified peripherals, and
cables in some cases, can also increase leakage current or compromise the safety of the
grounding scheme.

Safety Information
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
8
Table 1 Cable Length Table
Description Maximum Cable Length
Tablet No cable
AC Adapter 2.0 m
C62B_H1300 Transducer 1.5 m
L154BH_H1300 Transducer 1.5 m
P42B6_H1300 Transducer 1.5 m
 The system is neither designed nor allowed to be used in conjunction with high-
frequency operation devices.
 The system is in compliance with the Ingress Protection Marking ratings IP22.
 Do not use this system under direct sunlight, near heat sources or in the presence of
flammable substances, otherwise an explosion may occur.
 When using this system for ultrasound examinations, use only the qualified ultrasound
gel that complies with system standards.
 Do not continuously scan the same part of a patient or expose the patient to prolonged
scanning, otherwise it may harm the patient.
 Do not stay at the same position for too long without taking a break while scanning
patients to prevent harm or neck injury.
 Follow the instructions on “Chapter 4 Preparing the System” on page 34 for complete
instructions on the installation of the transducers, power supply units and all peripheral
devices to the system.
 Improper installation of peripherals to the system may cause damage to the system,
peripherals, or personal injury to the operator or the patient.
 Do not use the system for any application until you have read, understood, and know all
the safety information, safety procedures, and emergency procedures contained in this
chapter. Operating the system without a proper awareness of safe use could lead to fatal
or other serious personal injury.
 The system is not qualified for ophthalmic use. Never use the system for eye scanning.
 The system can contain environmentally hazardous materials such as, but not limited to:
heavy metals, general recyclable metals, and plastics. This product should be recycled
according to local and national guidelines for recycling electronic equipment.
 When using additional peripheral equipment powered from an electrical source other than
the ultrasound system, the combination is considered to be a medical system. It is your
responsibility to comply with IEC 60601-1 and test the system to those requirements.
 Do not use non-medical peripherals, such as report printers, within 1.5 m (5 ft) of a
patient, unless the non-medical peripherals receive power from an isolation transformer
that meets medical safety standards, as defined by standard IEC 60601-1.
 Images printed on a report printer are intended only for reference and should not be used
for diagnostic purposes.
 For proper disposal of this system, please contact your distributor.

Safety Information
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
9
Symbols
The following symbols provide information about the system’s labels and regulatory compliance.
CAUTION
Do not use a brush on the system’s labels.
System Label Icons
Table 2 System Label Icons
Symbol Title of Symbol and Description Standard Designation Number/
Title of Standard
Catalogue Number
Indicates the product model.
ISO 15223-1:2016
Medical devices - Symbols to
be used with medical device
labels, labeling, and information
to be supplied - Part 1: General
requirements
Serial Number
Indicates the serial number of the system.
ISO 15223-1:2016
Medical devices - Symbols to
be used with medical device
labels, labeling, and information
to be supplied - Part 1: General
requirements
Unique Device Identification
Indicates the UDI number of the system. N/A
Manufacturer
Qisda Corporation manufactures the system.
ISO 15223-1:2016
Medical devices - Symbols to
be used with medical device
labels, labeling, and information
to be supplied - Part 1: General
requirements
Date of Manufacture
ISO 15223-1:2016
Medical devices - Symbols to
be used with medical device
labels, labeling, and information
to be supplied - Part 1: General
requirements
Authorized Representative in the European
Community
ISO 15223-1:2016
Medical devices - Symbols to
be used with medical device
labels, labeling, and information
to be supplied - Part 1: General
requirements
CE Marking Certification with Notified Body
Number 1639
Medical Devices Directive, 93/42/
EEC

Safety Information
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
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Symbol Title of Symbol and Description Standard Designation Number/
Title of Standard
Compliance With RED Directive
Radio Equipment Directive
2014/53/EU (RED)
Commission Implementing
Regulation (EU) 2017/1354
Final Disposal Of Your System
Final disposal is when you dispose of the system
in such a way that it can no longer be used for its
intended purposes.
For more information, see “WEEE” on page 4.
Directive 2012/19/EU of the
European Parliament and of
the Council of 4 July 2012 on
Waste Electrical and Electronic
Equipment (WEEE)
Refer To The Operating Instructions
Indicates that the user should read the Operating
Instructions for information on using this
equipment.
IEC 60601-1:2005+A1:2012
Medical electrical equipment -
Part 1: General requirements
for basic safety and essential
performance
Type BF Equipment Applied Part
The system provides protection against electric
shock.
IEC 60601-1:2005+A1:2012
Medical electrical equipment -
Part 1: General requirements
for basic safety and essential
performance
Include RF Transmitters, Apply RF
Electromagnetic Energy For Diagnosis
IEC 60601-1-2:2007+AC:2010
Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral standard:
Electromagnetic compatibility –
Requirements and tests
Tablet IP Code, International Protection
Marking
IEC 60529
Graphical symbols for use on
equipment
Transducer IP Code, International Protection
Marking
IEC 60529
Graphical symbols for use on
equipment
Caution
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions that
cannot, for a variety of reasons, be presented on
the medical device itself.
ISO 15223-1:2016
Medical devices - Symbols to
be used with medical device
labels, labeling, and information
to be supplied - Part 1: General
requirements

Safety Information
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
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Shipping Label Icons
Table 3 Shipping Label Icons
Symbol Title of Symbol and Description Standard Designation
Number/Title of Standard
This Side Up
ISO 7000
Graphical symbols for use
on equipment -- Registered
symbols
Fragile, Handle With Care
ISO 7000
Graphical symbols for use
on equipment -- Registered
symbols
Maximum Stacking Height
ISO 7000
Graphical symbols for use
on equipment -- Registered
symbols
Maximum Stacking Weight
ISO 7000
Graphical symbols for use
on equipment -- Registered
symbols
Keep Dry
ISO 7000
Graphical symbols for use
on equipment -- Registered
symbols
Temperature Limit
The system must be stored in the original shipping
container in environments between -20°C and
60°C (-13°F and 140°F).
ISO 7000
Graphical symbols for use
on equipment -- Registered
symbols
Humidity Limitation
The system must be stored in the original shipping
container in environments with 20% to 95% relative
humidity and non-condensing.
ISO 7000
Graphical symbols for use
on equipment -- Registered
symbols
Atmospheric Pressure Limitation
The system must be stored in the original shipping
container in environments between 700 hPa
(525 mmHg) and 1060 hPa (795 mmHg) air
pressure.
ISO 7000
Graphical symbols for use
on equipment -- Registered
symbols
System Button
Table 4 System Button
Symbol Description
Power button
 Press and hold the Power button to turn on/off the system.
 Press the Power button to enter or exit Sleep mode.

Safety Information
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
12
Electrical Safety
Only trained medical personnel should operate this system. This system complies with the following
standards:
 Electrical:
 ANSI/AAMI ES60601-1:2005(R2012) + C1(2009) + A1(2012) + A2(2010)
 IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC
60601-1: 2012 reprint), EN 60601-1:2006 + A1:2013
 IEC 60601-2-37 (ed.2), am1 for use in conjunction with IEC 60601-1 (ed.3), am1 with Corr1
and Corr2
 EN 60601-2-37:2008, am1:2015
 EMC/EMI:
 IEC 60601-1-2:2014
 EN 60601-1-2:2015
 Harmful liquid protection:
 For the main system: IP22 (without power adapter)
 For the transducer: IPx7
 For the power adapter: IP20
For maximum safety, observe the following guidelines strictly:
WARNINGS
 The system and patient-applied parts meet the standard IEC 60601-1. Applied voltages
exceeding the standard, although unlikely, may result in electrical shock to the patient or
operator.
 Shock hazards exist if the power adapter is damaged or is not properly grounded. Use
only the supplied medical grade power adapter.
 Plug the system into a hospital-grade, three-hole outlet, and do not circumvent the power
cord.
 To avoid the risk of electric shock, connect the system only to properly grounded wall
outlets.
 Only authorized service technicians can make internal replacements of the system.
 Do not operate the system in the presence of flammable gases or anesthetics. Explosion
can result. The system is not compliant in AP/APG environments as defined by IEC
60601-1.
 Do not use a transducer if the transducer or cable is damaged. Contact technical support
for replacement of the damaged equipment (See “Contact Information” on page 2).
 All peripheral devices connected to the system must comply with IEC 60601 or IEC 60950-
1.
 To avoid risk of electrical shock hazards, always inspect the transducer before use.
Check the face, housing, and cable before use. Do not use if the face is cracked, chipped,
or torn; the housing is damaged; or the cable is abraded.
 Transducer cables have strain reliefs at terminations. Inspect cables regularly to detect
damaged, frayed, or broken cables that might contact a patient.

Safety Information
BenQ Diagnostic Ultrasound System B00114RC4-07 EN 20/09/11
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Battery Usage/Disposal
WARNINGS
 Do not disassemble the system.
 Use only the supplied battery. Using an unapproved battery may cause the system to
explode and result in serious damage to your health or property.
 Do not replace, heat, crush, puncture, short external contacts, or incinerate the battery.
 Use only the supplied power adapter to charge the battery.
 Incorrect use of the battery may cause a leak of chemicals or explosion. The leak of
chemicals may harm the skin. If any chemicals leak from the device, use a dry cloth to
wipe it clean and contact your distributor for help.
CAUTION
 Dispose of used batteries according to the instructions.
Electrical Fast Transients (EFT)
The system complies with the IEC 60601-1-2 standard for susceptibility to electrical fast transients
(EFT) on the power line. However, if the system experiences EFT on the power line, artifacts (vertical
lines, excessive noise in image, etc.) may appear on the ultrasound image. To eliminate these
artifacts caused by an EFT condition, the operator should either:
 Disconnect the system from the power source by unplugging the power cord from the tablet, and
run the system on its internal battery.
Or
 Unplug the power cord from the wall and move to a different power source that is not
experiencing this condition.
Conducted Susceptibility (CS)
The system complies with the IEC 60601-1-2 standard for susceptibility to Conducted Susceptibility
(CS) on the power line. However, due to its nature of being susceptible to interference generated
by RF energy sources, such as medical devices, information technology products, and radio and
television transmission towers, the following table lists some of the typical interferences or artifacts
that may appear on the ultrasound image, which are easily distinguishable by sonographers.
Table 5 Typical Interferences or Artifacts that May Appear on the Ultrasound Image
Imaging Mode Conducted EM Field
B mode White beams, dots, dashes, or diagonal lines near the center of the image.
Color mode Color flashes, dots, dashes, or changes in the color noise level.
M-mode White beams, dots, dashes, diagonal lines, or increase in image
background noise
To eliminate these artifacts caused by a CS condition, the operator needs to determine if an artifact
caused by interference will have a negative impact on image quality and the subsequent diagnosis.
Consequently, the system should only be operated by someone who has received proper training
and is experienced in the use and operation of an ultrasound system. If abnormal performance is
observed, the operator should either: