CLARIUS C3 User manual

Clarius Ultrasound
Scanner 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 www.clarius.com/terms-
conditions. 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”, the Clarius logo, “Ultrasound Anywhere,” “Point-and-Shoot Ultrasound”, “Act One”,
“Tri-Scanner”, “My New Stethoscope”, and “It’s About the Image” are trademarks or registered
trademarks, and are the sole and exclusive property of Clarius.
The Clarius products/services referenced in this document may be covered by one or more
patents or pending patent applications. See www.clarius.com/patents for details.
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.
© 2019 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.
15-03-00001

i
Table of Contents
About This Manual ........................................................................................................1
Target Audience...................................................................................................................1
Document Conventions .....................................................................................................2
Icons...........................................................................................................................................2
Symbols Glossary....................................................................................................................2
Chapter 1: About the Clarius Ultrasound Scanner.....................................5
Scanner Description ................................................................................................ 6
Scanner Dimensions................................................................................................ 7
Product Usage........................................................................................................... 8
Indications for Use.........................................................................................................8
Contraindications...........................................................................................................16
Hardware.................................................................................................................... 17
Warranty...........................................................................................................................17
Disposal ............................................................................................................................17
Security ...................................................................................................................... 18
Information Security......................................................................................................18
Network Security............................................................................................................18
Confidentiality................................................................................................................19
Integrity ............................................................................................................................19
Availability.......................................................................................................................19
Accountability .................................................................................................................20
System Requirements............................................................................................. 20
Chapter 2: Using the Clarius Ultrasound Scanner......................................21
Downloading the Clarius App ............................................................................... 21
Turning the System on & off ................................................................................. 22
Starting the Clarius App................................................................................................22
Exiting the Clarius App..................................................................................................22
Inserting & Removing the Battery ....................................................................... 22
Inserting the Clarius Battery........................................................................................22
Removing the Battery....................................................................................................23

Clarius Ultrasound Scanner
User Manual revision 9 ii
A Quick Tour...............................................................................................................23
Screen Overview ............................................................................................................23
Connecting Your Smart Device to the Clarius Scanner.........................................26
Managing Exams .......................................................................................................27
Error Messages ...............................................................................................................28
Imaging .......................................................................................................................29
Using the Measuring Tools ..........................................................................................29
Updating the Clarius Ultrasound Scanner ..........................................................30
Software Updates ..........................................................................................................30
Firmware Updates..........................................................................................................30
Maintenance ..............................................................................................................30
Hardware Maintenance.................................................................................................31
System Maintenance.....................................................................................................33
Chapter 3: Accessories .............................................................................34
Clarius Cart.................................................................................................................35
Parts ..................................................................................................................................35
Setting up.........................................................................................................................37
Using the Clarius Cart ...................................................................................................37
Maintenance....................................................................................................................38
Troubleshooting.............................................................................................................38
Clarius Battery Charger Hub ..................................................................................38
Parts ..................................................................................................................................39
Setting up.........................................................................................................................40
Using the Clarius Battery Charger Hub .....................................................................40
Maintenance....................................................................................................................41
Troubleshooting.............................................................................................................41
Clarius Fan..................................................................................................................42
Clarius Clip-on...........................................................................................................42
Chapter 4: Cleaning & Disinfecting ..........................................................44
Cleaning......................................................................................................................45
Cleaning the Clarius Scanner ......................................................................................45
Cleaning the Clarius Cart .............................................................................................46
Cleaning the Clarius Battery Charger Hub ...............................................................46
Cleaning the Fan ............................................................................................................47
Cleaning the Clarius Clip-on .......................................................................................47
Disinfecting................................................................................................................47

Clarius Ultrasound Scanner
User Manual revision 9 iii
Disinfecting the Clarius Scanner................................................................................47
Disinfecting the Fan ......................................................................................................49
Disinfecting the Clarius Clip-on .................................................................................50
Spaulding Classification .........................................................................................51
Chapter 5: Safety......................................................................................52
About Diagnostic Ultrasounds...............................................................................52
Interactions with Matter...............................................................................................52
Studies..............................................................................................................................52
Benefits & Risks..............................................................................................................53
Safety Topics .............................................................................................................53
Product Safety ................................................................................................................54
Battery Safety .................................................................................................................55
Cleaning Safety ..............................................................................................................56
Clinical Safety .................................................................................................................58
Biological Safety ............................................................................................................59
ALARA Principle ..............................................................................................................61
Fire & Electrical Safety .................................................................................................70
Electromagnetic Safety ................................................................................................71
Chapter 6: References ..............................................................................77
Compliance Statement............................................................................................77
The Clarius Ultrasound Scanner............................................................................77
Product Classification ................................................................................................... 77
Product Serial Number..................................................................................................78
System Specifications...................................................................................................78
Scanner Specifications .................................................................................................79
Standards....................................................................................................................80
Biocompatibility.............................................................................................................80
Chemical ..........................................................................................................................80
Electrical Safety..............................................................................................................80
Federal..............................................................................................................................81
Labeling............................................................................................................................81
Quality ..............................................................................................................................81
Security & Privacy..........................................................................................................83
Wireless............................................................................................................................83
Doppler Sensitivity ..................................................................................................84
Acoustic Output Tables ..........................................................................................85

Clarius Ultrasound Scanner
User Manual revision 9 iv
Clarius Scanner C3: B-Mode & M-Mode ...................................................................85
Clarius Scanner C3: Color Doppler Mode ................................................................86
Clarius Scanner C3: Pulsed Wave Mode ..................................................................87
Clarius Scanner C3 with Clarius Clip-on C3-L: B-Mode ........................................88
Clarius Scanner C7: B-Mode & M-Mode ...................................................................89
Clarius Scanner C7: Color Doppler Mode ................................................................90
Clarius Scanner C7: Pulsed Wave Mode ..................................................................91
Clarius Scanner EC7: B-Mode & M-Mode .................................................................92
Clarius Scanner EC7: Color Doppler Mode ..............................................................93
Clarius Scanner EC7: Pulsed Wave Mode ................................................................94
Clarius Scanner L7: B-Mode & M-Mode ...................................................................95
Clarius Scanner L7: Color Doppler Mode ................................................................96
Clarius Scanner L7: Pulsed Wave Mode ...................................................................97
Clarius Scanner L7: Needle Enhance Mode .............................................................98
Clarius Scanner L7: Ocular (Ophthalmic) Mode .....................................................99
Cleaners & Disinfectants ........................................................................................100
Cleaner & Disinfectant Usage.....................................................................................100
Cleaner & Disinfectant Details ...................................................................................101
Sterilization Systems ....................................................................................................101
Glossary of Terms.....................................................................................................101
Acoustic Outputs............................................................................................................102
Acoustic Artifacts ...........................................................................................................104
Known Issues .............................................................................................................107
Revision History........................................................................................................107

1
About This Manual
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
Scanner.
• 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, regulatory requirements, terms
and conditions, glossary of terms, and acoustic output data.
Access to user documentation may be affected by: Internet availability and accessibility,
website availability, and local electromagnetic interference.
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.
To obtain a printed copy of this manual at no additional cost, go to www.clarius.com/contact
and contact Clarius.

Clarius Ultrasound Scanner
User Manual revision 9 2
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 6417, (EN) ISO
15223-1, and EN 15986.
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 7000—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT—REGISTERED SYMBOLS
Symbol Reference Title Description
3082 Manufacturer Indicates the medical device manufacturer, as defined in EU Directives 90/
385/EEC, 93/42/EEC and 98/79/EC.
2497 Date of manufacture Indicates the date when the medical device was manufactured.
2493 Catalogue number Indicates the manufacturer's catalogue number so that the medical device
can be identified.
2498 Serial number Indicates the manufacturer's serial number so that a specific 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.

Clarius Ultrasound Scanner
User Manual revision 9 3
You may see some of these standard symbols on your Clarius Scanner, accessories, and
packaging:
0626 Keep away from rain 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 Measure humidity Indicates the range of humidity to which the medical device can be safely
exposed.
1641 Operator's manual;
operating instructions
Indicates the need for the user to consult the instructions for use.
0434A 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.
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 6417 5172 Class II equipment To identify equipment meeting the safety requirements
specified for Class II equipment according to IEC 60536.
IEC 6417 5957 For indoor use only To identify electrical equipment designed primarily for
indoor use.
IEC 6417 5333 Type BF applied part To identify a type BF applied part complying with IEC
60601-1.
STANDARD: ISO 7000—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT—REGISTERED SYMBOLS

Clarius Ultrasound Scanner
User Manual revision 9 4
You may see these other symbols on your Clarius Scanner, accessories, and packaging:
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 Council Directive 93/42/EEC.
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, 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.
ANATEL Conforms to the Brazilian Agency of Telecommunications.
RCM Regulatory Compliance Mark for Australia and New Zealand.
NCC Conforms to Taiwan’s National Communications Commission.
n/a Do not stack boxes.
n/a Do not use knife to open.
n/a Recycle Li-ion battery in accordance with local, state, and federal regulation

5
1
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.
• 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.
• Users are responsible for image quality and diagnosis.
• This device complies with part 15 of the FCC rules. 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.
• This product has demonstrated EMC compliance under
conditions that included the use of compliant peripheral
devices. It is important that you use compliant peripheral

Clarius Ultrasound Scanner Scanner Description
User Manual revision 9 6
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>90%). (2) Ambient temperatures that are
excessively high (40°C / 104°F) or excessively low (0°C / 32°F).
• Unqualified/untrained personnel purchasing and using the Clarius Scanner may be unable
to attain quality images.
Users will 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).
Caution: Federal law restricts this device to sale by or on the order of a physician.
Scanner Description
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 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 houses a battery and
power generator, multichannel beamformer, prescan converter and Wi-Fi components. The
battery is removable and comes with a separate charger.

Clarius Ultrasound Scanner Scanner Dimensions
User Manual revision 9 7
Scanner Dimensions
Battery manufacturer Clarius
Battery chemistry Li-ion
Battery management JEITA guideline compatible charger, in-pack fuel gauge with protection circuitry, and temperature
monitoring
Clarius Battery life 500 discharge cycles before reduction in charge
Clarius Battery Charger Input: 100-240 VAC, 50/60 Hz, 0.5-0.2 A
Output: 12 VDC, 1.5 A
Scanner 7.2 V/2350 mAh
Item Length (in/mm) Width (in/mm) Height (in/mm) Weight (oz/g)
Clarius Scanner C3 3.94/100 1.66/42 6.65/169 16.4/465
Clarius Scanner C7 3.94/100 1.66/42 6.89/175 15.7/445
Clarius Scanner L7 3.94/100 1.66/42 6.65/169 15.4/437
Clarius Scanner EC7 3.94/100 1.66/42 13.03/331 15.9/450
Clarius Battery 2.95/75 0.67/17 2.83/72 3.6/103
Clarius Battery Charger 3.15/80 3.50/89 1.26/32 1.9/55

Clarius Ultrasound Scanner Product Usage
User Manual revision 9 8
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 ,2 , fetal, abdominal, intra-
operative (non-neurological), pediatric, small organ, cephalic (adult)2, trans-rectal3, trans-
vaginal3, 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 professionals4.
1. Only applicable to the L7 scanner.
2. US, Canada, EU, and Singapore only.
3. Only in countries where Clarius Scanner EC7 is available.
4. IEC 60601-1-12 is valid in North America only.

Clarius Ultrasound Scanner Product Usage
User Manual revision 9 9
Indications for Use Tables
Clarius Ultrasound Scanner
SYSTEM: CLARIUS ULTRASOUND SCANNER
INTENDED 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 P
Fetal Imaging &
Other
Fetal P P P P P B+M; B+CD; B+PD; B+PWD
Abdominal P P P P P B+M; B+CD; B+PD; B+PWD Note 1
Intra-operative
(Abdominal organs & vascular)
P P P P P B+M; B+CD; B+PD; B+PWD Note 1
Laparoscopic
Pediatric P P P P P B+M; B+CD; B+PD; B+PWD Note 1
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
P P P P P B+M; B+CD; B+PD; B+PWD Note 1
Neonatal Cephalic
Adult Cephalic P P P P P B+M; B+CD; B+PD; B+PWD
Trans-rectal P P P P P B+M; B+CD; B+PD; B+PWD
Trans-vaginal P P P P P B+M; B+CD; B+PD; B+PWD
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional) P P P P P B+CD; B+PD; B+PWD Note 1
Musculo-skeletal (Superficial) P P P P P B+CD; B+PD Note 1
Intravascular
Other (Urology, Gynecology) P P P P P B+M; B+CD; B+PD; B+PWD
Cardiac Cardiac Adult P P P P B+M; B+CD; B+PD; B+PWD
Cardiac Pediatric P P P P B+M; B+CD; B+PWD
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel P P P P P B+M; B+CD; B+PD; B+PWD Note 1
Other (Carotid) P P P P P B+M; B+CD; B+PD; B+PWD Note 1
N = new indication; P = previously cleared by FDA
Note 1: Needle Enhancement in B-Mode.

Clarius Ultrasound Scanner Product Usage
User Manual revision 9 10
Clarius Scanner C3
DEVICE NAME: CLARIUS SCANNER C3
INTENDED 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 P P P P P B+M; B+CD; B+PD; B+PWD
Abdominal P P P P P B+M; B+CD; B+PD; B+PWD
Intra-operative
(Abdominal organs & vascular)
P P P P P B+M; B+CD; B+PD; B+PWD
Laparoscopic
Pediatric P P P P P B+M; B+CD; B+PD; B+PWD
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
Neonatal Cephalic
Adult Cephalic P P P P P B+M; B+CD; B+PD; B+PWD
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional) P P P P P B+M; B+CD; B+PD; B+PWD
Musculo-skeletal (Superficial)
Intravascular
Other (Urology, Gynecology) P P P P P B+M; B+CD; B+PD; B+PWD
Cardiac Cardiac Adult P P P P B+M; B+CD; B+PWD
Cardiac Pediatric P P P P B+M; B+CD; B+PWD
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel P P P P P B+M; B+CD; B+PD; B+PWD
Other (Carotid)
N = new indication; P = previously cleared by FDA
Note 1: Needle Enhancement in B-Mode.

Clarius Ultrasound Scanner Product Usage
User Manual revision 9 11
C3 Convex Scanner with C3-L Clip-on
DEVICE NAME: C3 CONVEX SCANNER WITH C3-L CLIP-ON
INTENDED 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
Intra-operative
(Abdominal organs & vascular)
Laparoscopic
Pediatric
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
P P P P P 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) P P P P P B+M; B+CD; B+PD; B+PWD
Musculo-skeletal (Superficial) P P P P P B+M; B+CD; B+PD; B+PWD
Intravascular
Other (Urology, Gynecology)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel P P P P P B+M; B+CD; B+PD; B+PWD
Other (Carotid) P P P P P B+M; B+CD; B+PD; B+PWD
N = new indication; P = previously cleared by FDA

Clarius Ultrasound Scanner Product Usage
User Manual revision 9 12
C3 Convex Scanner with C3-P Clip-on
DEVICE NAME: C3 CONVEX SCANNER WITH C3-P CLIP-ON
INTENDED 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
Intra-operative (Abdominal organs &
vascular)
Laparoscopic
Pediatric
Small Organ (Thyroid, Prostate,
Scrotum, Breast)
Neonatal Cephalic
Adult Cephalic P P P P P B+M; B+CD;
B+PD; B+PWD
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Urology, Gynecology)
Cardiac Cardiac Adult P P P P P B+M; B+CD;
B+PD; B+PWD
Cardiac Pediatric P P P P P B+M; B+CD;
B+PD; B+PWD
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel
Other (Carotid)
N = new indication; P = previously cleared by FDA
Note 1: Needle Enhancement in B-Mode.

Clarius Ultrasound Scanner Product Usage
User Manual revision 9 13
Clarius Scanner C7
DEVICE NAME: CLARIUS SCANNER C7
INTENDED 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 P P P P P B+M; B+CD; B+PD; B+PWD
Abdominal P P P P P B+M; B+CD; B+PD; B+PWD
Intra-operative
(Abdominal organs & vascular)
P P P P P B+M; B+CD; B+PD; B+PWD
Laparoscopic
Pediatric P P P P P B+M; B+CD; B+PD; B+PWD
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
P P P P P 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) P P P P P B+M; B+CD; B+PD; B+PWD
Musculo-skeletal (Superficial)
Intravascular
Other (Urology, Gynecology) P P P P P B+M; B+CD; B+PD; B+PWD
Cardiac Cardiac Adult P P P P P B+M; B+CD; B+PD; B+PWD
Cardiac Pediatric P P P P B+M; B+CD; B+PWD
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel P P P P P B+M; B+CD; B+PD; B+PWD
Other (Carotid)
N = new indication; P = previously cleared by FDA
Note 1: Needle Enhancement in B-Mode.

Clarius Ultrasound Scanner Product Usage
User Manual revision 9 14
Clarius Scanner EC7
DEVICE NAME: CLARIUS SCANNER EC7
INTENDED 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 P P P P P B+M; B+CD; B+PD; B+PWD
Abdominal P P P P P B+M; B+CD; B+PD; B+PWD
Intra-operative
(Abdominal organs & vascular)
Laparoscopic
Pediatric
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
P P P P P B+M; B+CD; B+PD; B+PWD
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P P B+M; B+CD; B+PD; B+PWD
Trans-vaginal P P P P P B+M; B+CD; B+PD; B+PWD
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Urology, Gynecology) P P P P P 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)
N = new indication; P = previously cleared by FDA
Note 1: Needle Enhancement in B-Mode.