CLARIUS HD3 User manual

Clarius Ultrasound Scanner -
HD3 Scanners User Manual

Disclaimer:
This disclaimer extends to all printed matter accompanying the Clarius Ultrasound Scanner.
This manual is licensed under the Terms and Conditions available at clarius.com/terms. You may
not use this manual except in compliance with the license. The information contained in these
materials is proprietary and confidential to Clarius Mobile Health Corp. (“Clarius“) and is
provided for the sole use of the individual or entity to whom it is addressed and therefore these
materials must be kept in the strictest confidence. No portion of this manual may be copied,
reproduced, republished, modified, sold, disclosed, or distributed without the prior written
permission of Clarius. Unauthorized copying or distribution of this manual, in addition to
infringing copyright, may reduce the ability of Clarius to provide updates and current
information to users.
Clarius has taken care to ensure the accuracy of this document, however, revisions may not be
possible in all situations. Information in this document may be subject to change without notice,
and Clarius assumes no liability for errors or omissions. Clarius reserves the right to make
changes without further notice to any products herein to improve reliability, function, or design.
Clarius may 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.
“Clarius”, “Ultrasound Anywhere,” “Point-and-Shoot Ultrasound”, “Act One”, “Tri-Scanner”, “My
New Stethoscope”, “It’s About the Image,” the Clarius logo, and the Clarius Live logo are
trademarks or registered trademarks and are the sole and exclusive property of Clarius.
Listing of applicable U.S. Patents in compliance with 35 U.S.C. s. 287: www.clarius.com/patents.
All names used in Clarius (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 Clarius
Ultrasound Scanner. Any similarity to real people is a coincidence.
© 2023 Clarius Mobile Health Corp.
All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any
means, electronic, mechanical, or otherwise, is prohibited without the prior written consent of
the copyright owner.
Published in Canada.
15-03-00118

i
Table of Contents
About This Manual........................................................................................... 1
Target Audience ...................................................................................................2
Document Conventions ........................................................................................2
Chapter 1: About the Clarius Ultrasound Scanner .....................................6
Device Description..........................................................................................7
Product Dimension .........................................................................................8
Product Usage ................................................................................................8
Indications for Use...............................................................................................8
Intended Patient Population...............................................................................8
Precautions ..........................................................................................................18
Hardware ........................................................................................................19
Warranty ..............................................................................................................19
Disposal................................................................................................................19
Security............................................................................................................19
Information Security............................................................................................19
Network Security .................................................................................................20
Confidentiality......................................................................................................20
Integrity ................................................................................................................21
Availability............................................................................................................21
Accountability ......................................................................................................21
System Requirements.....................................................................................22
Chapter 2: Using the Clarius Ultrasound Scanner.....................................23
Downloading the Clarius App .......................................................................23
Turning the System on & off ..........................................................................24
Starting the Clarius App .....................................................................................24
Exiting the Clarius App........................................................................................24
Imaging ...........................................................................................................24
Start Scanning .....................................................................................................24
Scanner Notifications..........................................................................................26
Voice Controls .................................................................................................27

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Start Voice Controls ............................................................................................ 27
Turn off Voice Controls ....................................................................................... 28
Voice Command Dictionary ............................................................................... 28
Updating the Clarius Ultrasound Scanner ................................................... 28
Software Updates ............................................................................................... 28
Firmware Updates .............................................................................................. 28
Maintenance................................................................................................... 28
Hardware Maintenance ..................................................................................... 29
System Maintenance .......................................................................................... 29
Chapter 3: Accessories ............................................................................... 30
Clarius Charger HD3......................................................................................30
About the Clarius Charger HD3......................................................................... 30
Setting Up the Clarius Charger HD3 ................................................................. 32
Clarius Power Fan HD3.................................................................................. 32
About the Clarius Power Fan HD3..................................................................... 33
Charging the Clarius Scanner HD3 ................................................................... 33
Chapter 4: Cleaning & Disinfecting............................................................ 35
Cleaning .......................................................................................................... 36
Cleaning the Clarius Scanner HD3 .................................................................... 36
Cleaning the Clarius Power Fan HD3................................................................ 37
Cleaning the Micro USB Cable .......................................................................... 37
Cleaning the Clarius Charger HD3.................................................................... 37
Disinfecting ..................................................................................................... 38
Disinfecting the Clarius Scanner HD3 ............................................................... 38
Disinfecting the Clarius Power Fan HD3........................................................... 39
Disinfecting the Micro USB Cable ..................................................................... 39
Disinfecting the Clarius Charger HD3............................................................... 40
Spaulding Classification ................................................................................ 40
Chapter 5: Safety........................................................................................ 41
About Diagnostic Ultrasounds....................................................................... 41
Interactions with Matter..................................................................................... 41
Studies.................................................................................................................. 41
Benefits & Risks.................................................................................................... 42
Safety Topics .................................................................................................. 42

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Product Safety..................................................................................................... 43
Battery Safety...................................................................................................... 44
Cleaning Safety ................................................................................................... 44
Clinical Safety...................................................................................................... 47
Biological Safety ................................................................................................. 47
ALARA Principle................................................................................................... 49
Fire & Electrical Safety........................................................................................ 59
Electromagnetic Safety ...................................................................................... 60
Chapter 6: References ................................................................................ 66
Compliance Statement .................................................................................. 66
The Clarius Ultrasound Scanner ...................................................................66
Product Classification......................................................................................... 66
Product Serial Number ....................................................................................... 67
System Specifications ......................................................................................... 67
Environmental Specifications............................................................................. 69
Scanner Specifications ....................................................................................... 70
Standards........................................................................................................ 70
Chemical .............................................................................................................. 70
Electrical Safety .................................................................................................. 71
Labeling ............................................................................................................... 71
Quality.................................................................................................................. 71
Security & Privacy ............................................................................................... 73
Wireless ................................................................................................................ 73
Cleaners & Disinfectants................................................................................ 74
Cleaner & Disinfectant Usage............................................................................ 74
Cleaner & Disinfectant Details ........................................................................... 75
Glossary of Terms .......................................................................................... 75
Known Issues................................................................................................... 75
Chapter 7: Measurement Accuracy Tables ............................................... 76
Clarius Scanner C3 HD3 ...................................................................................... 77
Clarius Scanner C7 HD3 ...................................................................................... 78
Clarius Scanner EC7 HD3 ................................................................................... 79
Clarius Scanner L7 HD3 ...................................................................................... 80
Clarius Scanner L15 HD3 ..................................................................................... 81
Clarius Scanner L20 HD3 .................................................................................... 82
Clarius Scanner PA HD3 ..................................................................................... 83
Clarius Scanner PAL HD3 (Linear Array) ........................................................... 84

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Clarius Scanner PAL HD3 (Phased Array) ........................................................ 85
Acoustic Output Tables........................................................................ 86
Clarius Scanner C3 HD3: B-Mode ..................................................................... 86
Clarius Scanner C3 HD3: Color Doppler Mode ................................................ 87
Clarius Scanner C3 HD3: M-Mode .................................................................... 88
Clarius Scanner C3 HD3: PW Doppler Mode .................................................... 89
Clarius Scanner C7 HD3: B-Mode ..................................................................... 90
Clarius Scanner C7 HD3: Color Doppler Mode ................................................ 91
Clarius Scanner C7 HD3: M-Mode .................................................................... 92
Clarius Scanner C7 HD3: PW Doppler Mode .................................................... 93
Clarius Scanner EC7 HD3: B-Mode ................................................................... 94
Clarius Scanner EC7 HD3: Color Doppler Mode .............................................. 95
Clarius Scanner EC7 HD3: M-Mode .................................................................. 96
Clarius Scanner EC7 HD3: PW Doppler Mode .................................................. 97
Clarius Scanner L7 HD3: B-Mode ...................................................................... 98
Clarius Scanner L7 HD3: Color Doppler Mode ................................................. 99
Clarius Scanner L7 HD3: M-Mode ..................................................................... 100
Clarius Scanner L7 HD3: Needle Enhance B-Mode ......................................... 101
Clarius Scanner L7 HD3: Ocular (Ophthalmic) B-Mode ................................. 102
Clarius Scanner L7 HD3: PW Doppler Mode ..................................................... 103
Clarius Scanner L15 HD3: B-Mode ..................................................................... 104
Clarius Scanner L15 HD3: Color Doppler Mode ................................................ 105
Clarius Scanner L15 HD3: M-Mode ................................................................... 106
Clarius Scanner L15 HD3: Needle Enhance B-Mode ........................................ 107
Clarius Scanner L15 HD3: Ocular (Ophthalmic) B-Mode ................................ 108
Clarius Scanner L15 HD3: PW Doppler Mode ................................................... 109
Clarius Scanner L20 HD3: B-Mode .................................................................... 110
Clarius Scanner L20 HD3: Color Doppler Mode ............................................... 111
Clarius Scanner L20 HD3: M-Mode ................................................................... 112
Clarius Scanner L20 HD3: Needle Enhance B-Mode ....................................... 113
Clarius Scanner L20 HD3: Ocular (Ophthalmic) B-Mode ............................... 114
Clarius Scanner L20 HD3: PW Doppler Mode .................................................. 115
Clarius Scanner PA HD3: B-Mode ..................................................................... 116
Clarius Scanner PA HD3: Color Doppler Mode ................................................ 117
Clarius Scanner PA HD3: M-Mode .................................................................... 118
Clarius Scanner PA HD3: PW Doppler Mode .................................................... 119
Clarius Scanner PA HD3: Transcranial B-Mode ............................................... 120
Clarius Scanner PA HD3: Transcranial Color Doppler Mode .......................... 121
Clarius Scanner PA HD3: Transcranial M-Mode ............................................. 122
Clarius Scanner PA HD3: Transcranial PW Doppler Mode ............................. 123
Clarius Scanner PAL HD3: B-Mode, Linear Array ............................................ 124
Clarius Scanner PAL HD3: Color Doppler Mode, Linear Array ....................... 125
Clarius Scanner PAL HD3: M-Mode, Linear Array ........................................... 126
Clarius Scanner PAL HD3: Needle Enhance B-Mode, Linear Array ............... 127

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Clarius Scanner PAL HD3: Ocular (Ophthalmic) B-Mode, Linear Array ....... 128
Clarius Scanner PAL HD3: PW Doppler Mode, Linear Array ........................... 129
Clarius Scanner PAL HD3: B-Mode, Phased Array .......................................... 130
Clarius Scanner PAL HD3: Color Doppler Mode, Phased Array ..................... 131
Clarius Scanner PAL HD3: M-Mode, Phased Array ......................................... 132
Clarius Scanner PAL HD3: PW Doppler Mode, Phased Array ......................... 133
Revision History .................................................................................... 134

1
About This Manual
This manual provides instructions for use on the Clarius Ultrasound Scanner - HD3 Scanners
family of ultrasound scanners. For models that are not HD3, please refer to the appropriate
user manual at clarius.com/manuals.
This document is licensed as part of the purchase of the Clarius Ultrasound Scanner and meets
applicable regulatory requirements. Use of this document by unauthorized persons is strictly
prohibited.
This document contains the following information:
• About the Clarius Ultrasound Scanner: Describes the product, and lists technical
specifications, and its intended use.
• Using the Clarius Ultrasound Scanner: Shows you how to get started and begin scanning,
introduces you to the features and concepts, and helps you set up your system.
• Accessories: Describes additional accessories you can purchase for use with your Clarius
Ultrasound Scanner- HD3 Scanners.
• Cleaning & Disinfecting: Explains how to clean and disinfect your scanner and its
accessories.
• Safety: Outlines important safety standards, principles, and policies to follow when using
the product.
• References: Offers information such as product standards and regulatory requirements.
• Measurement Accuracy Tables: Displays the measurement accuracy and Doppler sensitivity
of each scanner and mode.
• Acoustic Output Tables: Displays acoustic data for each scanner and mode.
• Revision History: Displays a historic list of changes made to this document.
Access to user documentation may be affected by: Internet availability and accessibility,
website availability, and local electromagnetic interference.
To obtain a printed copy of this manual at no additional cost, go to clarius.com/contact and
contact Clarius.

Clarius Scanner HD3
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Target Audience
This document is written for trained medical professionals who operate and maintain your
Clarius Ultrasound Scanner. It contains instructions and reference material pertaining to the
usage and maintenance of the product.
Document Conventions
Icons
Symbols Glossary
The symbols shown in this document and on the Clarius Ultrasound Scanner are compliant
with current versions of the following standards: ISO 7000, ISO 7010, IEC 60417, and (EN) ISO
15223-1.
Icon Title of Icon Description
Alert Possible risks beyond the reasonable control of Clarius.
Do not do this This icon indicates actions to avoid.
Note This icon indicates informative material or helpful suggestions.
STANDARD: ISO 15223-1—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT—REGISTERED SYMBOLS
Symbol Reference Title Description
3082 Manufacturer Indicates the medical device manufacturer.
2497 Date of manufacture Indicates the date when the medical device was manufactured.

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You may see some of these standard symbols on your Clarius Scanner HD3, accessories, and
packaging:
2493 Catalogue number Indicates the manufacturer's catalogue number so that the medical device
can be identified.
2609 Non-sterile Indicates a medical device that has not been subjected to a sterilization
process.
0621 Fragile; handle with
care
Indicates a medical device that can be broken or damaged if not handled
carefully.
0626 Keep dry Indicates a medical device that needs to be protected from moisture.
0632 Temperature limit Indicates the temperature limits to which the medical device can be safely
exposed.
0224 Humidity limitation Indicates the range of humidity to which the medical device can be safely
exposed.
1641 Consult instructions
for use or consult
electronic instructions
for use
Indicates the need for the user to consult the instructions for use.
0434A Caution Indicates that caution is necessary when operating the device or control
close to where the symbol is placed, or that the current situation needs
operator awareness or operator action in order to avoid undesirable
consequence.
1135 General symbol for
recovery/recyclable
To indicate that the marked item or its material is part of a recovery or
recycling process.
OTHER STANDARDS—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT —REGISTERED SYMBOLS
Symbol Standard Reference Title Description
ISO 7010 M002 Refer to instruction
manual/booklet
Indicates to read the instruction manual/booklet before
starting work or before operating equipment or machinery.
IEC 60417 5172 Class II equipment To identify equipment meeting the safety requirements
specified for Class II equipment according to IEC 60536.
STANDARD: ISO 15223-1—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT—REGISTERED SYMBOLS
Symbol Reference Title Description

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You may see these other symbols on your Clarius Scanner HD3, accessories, and packaging:
IEC 60417 5957 For indoor use only To identify electrical equipment designed primarily for
indoor use.
IEC 60417 5333 Type BF applied part To identify a type BF applied part complying with IEC
60601-1.
OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT
Symbol Title Description
Power connector Indicates a barrel-type power connector.
RoHS compliant Identifies electrical and electronic equipment that meets the Restriction of
Hazardous Substances (RoHS) Directive 2011/65/EU.
European Conformity Conforms to European Medical Device Regulation 2017/745.
FCC Conforms to US Federal Communications Commission.
CSA certification Certified by the Canadian Standards Association. The number below this
symbol indicates the contract number.
Waste Electrical and
Electronic Equipment
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.
Ingress protection rating The equipment inside the enclosure is protected from tools and wires
greater than 1.0 millimeters, is dust-tight, and is also protected from
immersion up to 1 meter in depth for 30 minutes.
DC Direct current.
GS1 DataMatrix Identifies GS1 encoded DataMatrix.
Global Medical Device
Nomenclature Code
A system of internationally agreed generic descriptors used to identify all
medical device products.
Authorized representative in
the European Community
Indicates the Authorized representative in the European Community.
Authorized representative in
Switzerland
Indicates the authorized representative in Switzerland.
OTHER STANDARDS—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT —REGISTERED SYMBOLS
Symbol Standard Reference Title Description

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n/a Do not stack boxes.
n/a Do not use knife to open.
n/a Recycle scanner in accordance with local, state, and federal regulation.
Medical Device European Medical Device Regulation 2017/745.
Rx Only Caution: Federal (USA) law restricts this device to sale by or on the order of
a physician.
OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT
Symbol Title Description

6
About the Clarius
Ultrasound Scanner
Install, operate, and maintain this product according to the safety
and operating procedures in this manual, and only for its intended
purpose. Always use the information in this document with sound
clinical judgment and best clinical procedures.
This product is subject to the law in the jurisdiction that the product
is used. Install, use, and operate the product only in ways that adhere
to applicable laws or regulations, which have the force of law.
This device complies with part 15 of the FCC rules and Industry
Canada license-exempt RSS standard(s). Operation is subject to the
following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference
received, including interference that may cause undesired
operation.1
• Product package must be maintained with medical device. Do
not dispose.
• Using the product incorrectly, or for purposes other than those
intended and expressly stated by Clarius, may relieve Clarius or
its agents from all or some responsibility for 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 flammable gases or
anesthetics can cause an explosion.
• Install and operate medical equipment according to
electromagnetic compatibility (EMC) guidelines.
1. Le présent appareil est conforme avec la section 15 des règlementations FCC
ainsi qu'aux standards CNR d'Industrie Canada applicables aux appareils radio
exempts de licence. L'exploitation est autorisée aux deux conditions suivantes
: (1) l'appareil ne doit pas produire d'interférence, et (2) l'appareil doit
accepter toute interférence radioélectrique subi, même si l'interférence est
susceptible d'en compromettre le fonctionnement.

Clarius Scanner HD3 Device Description
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• Users are responsible for image quality and diagnosis.
• This product has demonstrated EMC compliance under conditions that included the use of
compliant peripheral devices. It is important that you use compliant peripheral devices to
reduce the possibility of causing interference to radios, televisions, and other electronic
devices.
• Circumstances in the patient’s environment may negatively impact the scanner and the
exam. For example: (1) Chemicals and gases in the operating room. (2) Altitudes below
-382 m or above 4000 m.
• Vulnerable patients, such as children and pregnant/nursing women, may be more prone to
the exposure of acoustic energy when the scanner is used for prolonged periods.
• Biological incompatibility may exist between the scanner materials used and the biological
tissues, cells, and body fluids of the patient/user, taking account of the intended purpose
of the scanner.
• Using the scanner in the patient environment may be unsafe if the following conditions
exist: (1) Extremes in humidity (RH<15% and RH>95%). (2) Ambient temperatures that are
excessively high (>40°C / 104°F) or excessively low (<-20°C /-4°F).
• Unqualified/untrained personnel purchasing and using the Clarius Scanner HD3 may be
unable to attain quality images.
• Each Clarius Scanner HD3 contains a Li-ion battery. Treat the battery with precaution.
Users should be trained medical professionals (e.g., doctors, nurses, technicians) with previous
training in ultrasound. Images produced by the scanner are transmitted wirelessly to the user’s
smart device (tablet or smart phone).
Device Description
For regulatory information in e-labeling format, open the Clarius App and go to the About
page.
The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic
ultrasound system used to acquire and display high-resolution, real-time ultrasound data
through a commercial off-the-shelf (COTS) Apple iOS or Android™ device. The Clarius
Ultrasound Scanner series of wireless scanners are Bluetooth and Wi-Fi-based scanners that
communicate with a traditional tablet/smartphone via direct Wi-Fi to allow users to export
ultrasound images and display in different modes of operation. The Clarius Scanner HD3
houses a battery and internal power supplies, multichannel beamformer, prescan converter,
and Wi-Fi components. The Clarius Scanner HD3 is supplied with a charger.
The system is a transportable ultrasound system intended for use in rotary-wing air
ambulances, road ambulances, and emergency medical service (EMS) environments where
healthcare is provided by trained healthcare professionals. The EC7 HD31and the Clarius
Charger HD31should be used in a stationary setting.
1. Not intended for EMS environment.

Clarius Scanner HD3 Product Dimension
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Product Dimension
Product Usage
Indications for Use
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and
accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging
and fluid flow analysis in the following applications: ophthalmic1, fetal, abdominal, intra-
operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-
vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult,
pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where
healthcare is provided by trained healthcare professionals.
Intended Patient Population
The system is intended for use for diagnostic ultrasound imaging and fluid flow analysis of
anatomical structures and fluids of adult and pediatric patients.
Item Length
(in/mm)
Width
(in/mm)
Thickness
(in/mm)
Weight
(oz/g)
Clarius Scanner C3 HD3 (CIDN 99-13-00018) 5.7/146 3.0/76 1.3/32 10.9/308
Clarius Scanner C7 HD3 (CIDN 99-13-00019) 5.9/151 3.0/76 1.3/32 10.2/289
Clarius Scanner EC7 HD3 (CIDN 99-13-00024) 12.2/310 3.0/76 1.3/32 11.5/326
Clarius Scanner L7 HD3 (CIDN 99-13-00020) 5.8/147 3.0/76 1.3/32 10.2/288
Clarius Scanner L15 HD3 (CIDN 99-13-00021) 5.8/147 3.0/76 1.3/32 10.2/290
Clarius Scanner L20 HD3 (CIDN 99-13-00022) 5.8/147 3.0/76 1.3/32 10.2/290
Clarius Scanner PA HD3 (CIDN 99-13-00023) 5.8/148 3.0/76 1.3/32 10.3/292
Clarius Scanner PAL HD3 (CIDN 99-13-00029) 5.8/148 3.0/76 1.3/32 10.8/307
1. Only applicable to the L7 HD3, L15 HD3, L20 HD3, & PAL HD3 scanners.

Clarius Scanner HD3 Product Usage
revision 9 9
Indications for Use Tables
Clarius Ultrasound Scanner HD3
SYSTEM: CLARIUS ULTRASOUND SCANNER HD3
INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:
Clinical Application Mode of Operation
General
(Track 1 Only)
Specific
(Tracks 1 & 3)
BMColor
Doppler
Power
Doppler
PW
Doppler
Combined (Specify) Other*
Ophthalmic Ophthalmic 
Fetal Imaging &
Other
Fetal     B+M; B+CD; B+PD; B+PWD
Abdominal     B+M; B+CD; B+PD; B+PWD Note 1
Intra-operative
(Abdominal organs & vascular)
    B+M; B+CD; B+PD; B+PWD Note 1
Laparoscopic
Pediatric     B+M; B+CD; B+PD; B+PWD Note 1
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
    B+M; B+CD; B+PD; B+PWD Note 1
Neonatal Cephalic
Adult Cephalic     B+M; B+CD; B+PD; B+PWD
Trans-rectal     B+M; B+CD; B+PD; B+PWD
Trans-vaginal     B+M; B+CD; B+PD; B+PWD
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)     B+CD; B+PD; B+PWD Note 1
Musculo-skeletal (Superficial)     B+CD; B+PD Note 1
Intravascular
Other (Urology, Gynecology)     B+M; B+CD; B+PD; B+PWD
Cardiac Cardiac Adult    B+M; B+CD; B+PD; B+PWD
Cardiac Pediatric    B+M; B+CD; B+PWD
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel     B+M; B+CD; B+PD; B+PWD Note 1
Other (Carotid)     B+M; B+CD; B+PD; B+PWD Note 1
Note 1: Needle Enhancement in B-Mode.

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Clarius Scanner C3 HD3
DEVICE NAME: CLARIUS SCANNER C3 HD3
INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:
Clinical Application Mode of Operation
General
(Track 1 Only)
Specific
(Tracks 1 & 3)
BMColor
Doppler
Power
Doppler
PW
Doppler
Combined (Specify) Other*
Ophthalmic Ophthalmic
Fetal Imaging &
Other
Fetal     B+M; B+CD; B+PD; B+PWD
Abdominal     B+M; B+CD; B+PD; B+PWD
Intra-operative
(Abdominal organs & vascular)
    B+M; B+CD; B+PD; B+PWD
Laparoscopic
Pediatric     B+M; B+CD; B+PD; B+PWD
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
Neonatal Cephalic
Adult Cephalic     B+M; B+CD; B+PD; B+PWD
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)     B+M; B+CD; B+PD; B+PWD
Musculo-skeletal (Superficial)
Intravascular
Other (Urology, Gynecology)     B+M; B+CD; B+PD; B+PWD
Cardiac Cardiac Adult    B+M; B+CD; B+PWD
Cardiac Pediatric    B+M; B+CD; B+PWD
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel     B+M; B+CD; B+PD; B+PWD
Other (Carotid)

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Clarius Scanner C7 HD3
DEVICE NAME: CLARIUS SCANNER C7 HD3
INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:
Clinical Application Mode of Operation
General
(Track 1 Only)
Specific
(Tracks 1 & 3)
BMColor
Doppler
Power
Doppler
PW
Doppler
Combined (Specify) Other*
Ophthalmic Ophthalmic
Fetal Imaging &
Other
Fetal     B+M; B+CD; B+PD; B+PWD
Abdominal     B+M; B+CD; B+PD; B+PWD
Intra-operative
(Abdominal organs & vascular)
    B+M; B+CD; B+PD; B+PWD
Laparoscopic
Pediatric     B+M; B+CD; B+PD; B+PWD
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
    B+M; B+CD; B+PD; B+PWD
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)     B+M; B+CD; B+PD; B+PWD
Musculo-skeletal (Superficial)
Intravascular
Other (Urology, Gynecology)     B+M; B+CD; B+PD; B+PWD
Cardiac Cardiac Adult     B+M; B+CD; B+PD; B+PWD
Cardiac Pediatric    B+M; B+CD; B+PWD
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel     B+M; B+CD; B+PD; B+PWD
Other (Carotid)

Clarius Scanner HD3 Product Usage
revision 9 12
Clarius Scanner EC7 HD3
DEVICE NAME: CLARIUS SCANNER EC7 HD3
INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:
Clinical Application Mode of Operation
General
(Track 1 Only)
Specific
(Tracks 1 & 3)
BMColor
Doppler
Power
Doppler
PW
Doppler
Combined (Specify) Other*
Ophthalmic Ophthalmic
Fetal Imaging &
Other
Fetal     B+M; B+CD; B+PD; B+PWD
Abdominal     B+M; B+CD; B+PD; B+PWD
Intra-operative
(Abdominal organs & vascular)
Laparoscopic
Pediatric
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
    B+M; B+CD; B+PD; B+PWD
Neonatal Cephalic
Adult Cephalic
Trans-rectal     B+M; B+CD; B+PD; B+PWD
Trans-vaginal     B+M; B+CD; B+PD; B+PWD
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Urology, Gynecology)     B+M; B+CD; B+PD; B+PWD
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel
Other (Carotid)

Clarius Scanner HD3 Product Usage
revision 9 13
Clarius Scanner L7 HD3
DEVICE NAME: CLARIUS SCANNER L7 HD3
INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:
Clinical Application Mode of Operation
General
(Track 1 Only)
Specific
(Tracks 1 & 3)
BMColor
Doppler
Power
Doppler
PW
Doppler
Combined (Specify) Other*
Ophthalmic Ophthalmic 
Fetal Imaging &
Other
Fetal
Abdominal     B+M; B+CD; B+PD; B+PWD Note 1
Intra-operative
(Abdominal organs & vascular)
    B+M; B+CD; B+PD; B+PWD Note 1
Laparoscopic
Pediatric     B+M; B+CD; B+PD; B+PWD Note 1
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
    B+M; B+CD; B+PD; B+PWD Note 1
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)     B+M; B+CD; B+PD; B+PWD Note 1
Musculo-skeletal (Superficial)     B+M; B+CD; B+PD; B+PWD Note 1
Intravascular
Other (Urology, Gynecology)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel     B+M; B+CD; B+PD; B+PWD Note 1
Other (Carotid)     B+M; B+CD; B+PD; B+PWD Note 1
Note 1: Needle Enhancement in B-Mode.