clarius_ultrasound_scanner_user_manual_march_sw_ver.pdf
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Clarius Ultrasound Scanner
User Manual
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Disclaimer:
This disclaimer extends to all printed matter accompanying the Clarius Ultrasound Scanner.
This manual is licensed under the Terms and Conditions available at https://www.clarius.me/
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” and the Clarius logo are trademarks or registered trademarks, and are the sole and
exclusive property of Clarius.
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.
Copyright © 2017 Clarius. All rights reserved.
Published in Canada.
15-03-00001
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Table of Contents
About This Manual ........................................................................................................ 1
Target Audience...................................................................................................................1
Document Conventions .....................................................................................................2
Touch Gestures........................................................................................................................2
Icons...........................................................................................................................................3
Symbols.....................................................................................................................................3
Chapter 1: About the Clarius Ultrasound Scanner .....................................9
Scanner Description ................................................................................................ 10
Scanner Dimensions................................................................................................ 11
Product Usage........................................................................................................... 12
Indications for Use .........................................................................................................12
Contraindications ...........................................................................................................20
Hardware.................................................................................................................... 20
Purchases & Upgrades ..................................................................................................20
Warranty...........................................................................................................................20
Disposal ............................................................................................................................20
Security ...................................................................................................................... 21
Information Security......................................................................................................21
Network Security ............................................................................................................21
Confidentiality ................................................................................................................22
Integrity ............................................................................................................................22
Availability.......................................................................................................................23
Accountability .................................................................................................................23
System Requirements............................................................................................. 23
Chapter 2: A Quick Tour ............................................................................25
Quick Start ................................................................................................................. 25
Overview of the Interface...................................................................................... 26
Icons ..................................................................................................................................26
Menu Icons ............................................................................................................................... 26
Tools Icons ............................................................................................................................... 27
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Status Icons.............................................................................................................................. 28
Menu Options..................................................................................................................29
Support ..................................................................................................................................... 29
Settings ..................................................................................................................................... 30
Exams ........................................................................................................................................ 31
Listen ......................................................................................................................................... 32
About ......................................................................................................................................... 33
Sign Out .................................................................................................................................... 34
Screen Overview.......................................................................................................34
Sign-in Page.....................................................................................................................34
Scanners Page .................................................................................................................35
Workflows Page..............................................................................................................36
Patient Demographics...................................................................................................37
Indications Page .............................................................................................................37
Imaging Page ...................................................................................................................38
Review Page ....................................................................................................................39
Impressions Page ...........................................................................................................39
System Capabilities..................................................................................................40
Status Lights ....................................................................................................................40
Audible Notifications ....................................................................................................41
Sleep Mode ......................................................................................................................41
Auto Shutdown ...............................................................................................................42
Scanner Locator ..............................................................................................................42
Chapter 3: Using the Clarius Ultrasound Scanner ..................................... 43
Downloading the Clarius App ................................................................................43
Apple iOS..........................................................................................................................43
Android™..........................................................................................................................44
Updating the Clarius Ultrasound Scanner...........................................................44
Software Updates...........................................................................................................44
Firmware Updates ..........................................................................................................44
Inserting & Removing the Battery ........................................................................45
Inserting the Battery......................................................................................................45
Removing the Battery....................................................................................................45
Turning the System on & off ..................................................................................46
Starting the Clarius App................................................................................................46
Exiting the Clarius App..................................................................................................46
Signing in & out.........................................................................................................46
Signing in..........................................................................................................................46
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Signing out.......................................................................................................................47
Connecting Your Smart Device to a Clarius Scanner .......................................47
Connecting Android™ Devices to Scanners ............................................................47
Connecting Apple iOS Devices to Scanners ............................................................48
Managing Exams .......................................................................................................48
Starting New Exams.......................................................................................................49
Pausing an Exam.............................................................................................................50
Ending an Exam ..............................................................................................................50
Resuming a Paused Exam.............................................................................................50
Managing Patient Information...............................................................................51
Entering Patient Information ......................................................................................51
Populating Indications..................................................................................................51
Selecting Scanning Modes......................................................................................51
B-Mode .............................................................................................................................51
Imaging .......................................................................................................................52
Adjusting Gain ................................................................................................................52
Turning Auto-Gain on & off ..................................................................................................52
Manually Adjusting Gain .......................................................................................................53
Using the Center Line....................................................................................................54
Freezing/Unfreezing Cineloops .................................................................................55
Saving Cineloops & Images .........................................................................................56
Cineloops ..................................................................................................................................56
Images........................................................................................................................................56
Zooming in & out ...........................................................................................................57
Changing Depth..............................................................................................................58
Rotating Images..............................................................................................................58
Using the Measuring Tools ..........................................................................................59
Common Measuring Tools ....................................................................................................59
OB/GYN Measuring Tools ......................................................................................................60
Measurement Accuracy .........................................................................................................60
Measurement Accuracy Table ..............................................................................................61
Using the Listen Mode ..................................................................................................61
Review Findings........................................................................................................62
Reviewing Cineloops & Images ..................................................................................63
Deleting Items ................................................................................................................63
Populating Impressions...........................................................................................63
Maintenance ..............................................................................................................63
Hardware Maintenance.................................................................................................64
Testing Scanners .....................................................................................................................64
Recharging Batteries ..............................................................................................................64
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Storing Scanners .....................................................................................................................65
System Maintenance .....................................................................................................66
Sending Activity Logs.............................................................................................................66
Help..............................................................................................................................66
Additional Training ........................................................................................................66
Error Messages ...............................................................................................................66
Need Help? ......................................................................................................................66
Chapter 4: Cleaning & Disinfecting .......................................................... 67
Cleaning the Clarius Scanner.................................................................................68
Disinfecting the Clarius Scanner...........................................................................69
Intermediate Disinfection............................................................................................69
High-Level Disinfection................................................................................................70
Spaulding Classification .........................................................................................71
Classification Guidelines .............................................................................................71
Non-Critical Class...........................................................................................................71
Semi-Critical Class .........................................................................................................72
Chapter 5: Safety...................................................................................... 73
About Diagnostic Ultrasounds...............................................................................73
Interactions with Matter...............................................................................................73
History ..............................................................................................................................73
Studies..............................................................................................................................74
Benefits & Risks..............................................................................................................74
Safety Topics .............................................................................................................75
Product Safety ................................................................................................................75
Product Warnings....................................................................................................................75
Product Compatibility............................................................................................................76
Battery Safety .................................................................................................................76
Cleaning Safety ..............................................................................................................77
Cleaners & Disinfectants.......................................................................................................77
Scanner Care ............................................................................................................................78
Clinical Safety .................................................................................................................79
Syringe Safety..........................................................................................................................79
Defibrillator Safety.................................................................................................................79
Biological Safety ............................................................................................................79
Latex...........................................................................................................................................79
Bioeffects..................................................................................................................................80
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ALARA Principle ..............................................................................................................81
Applying ALARA.......................................................................................................................82
Using System Controls to Implement ALARA ...................................................................82
Output Display.........................................................................................................................84
Acoustics ...................................................................................................................................87
Fire & Electrical Safety .................................................................................................91
Fire Safety.................................................................................................................................91
Electrical Safety.......................................................................................................................91
Electromagnetic Safety ................................................................................................92
Electromagnetic Compatibility............................................................................................92
Electrostatic Discharge Precautions...................................................................................93
Electromagnetic Emissions...................................................................................................93
Electromagnetic Immunity ...................................................................................................94
Electromagnetic Interference ..............................................................................................95
Separation Distance ...............................................................................................................95
Chapter 6: References .............................................................................. 98
Compliance Statement............................................................................................98
The Clarius Ultrasound Scanner ............................................................................98
Authorized Representative..........................................................................................98
Product Classification ...................................................................................................98
Product Serial Number..................................................................................................99
System Specifications...................................................................................................99
Scanner Specifications .................................................................................................100
Standards....................................................................................................................101
Acoustic ............................................................................................................................101
Biocompatibility.............................................................................................................101
Chemical ..........................................................................................................................101
Electrical Safety..............................................................................................................101
Labeling............................................................................................................................101
Quality ..............................................................................................................................102
Performance.............................................................................................................................102
Risk, Product Specification, Design Review, & Verification/Validation.....................102
Security & Privacy..........................................................................................................103
Wireless............................................................................................................................103
Acoustic Output Tables ...........................................................................................104
C3-45 Scanner ................................................................................................................104
C3-60 Scanner ................................................................................................................105
L7-38 Scanner.................................................................................................................106
Control Effects Guidance Documents..................................................................107
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Disinfectants & Cleaners ........................................................................................108
Compatibility Table Legend ........................................................................................108
Compatible Solutions for Scanners ...........................................................................108
Known Defects ..........................................................................................................109
Glossary of Terms .....................................................................................................109
Acoustic Outputs............................................................................................................109
Acoustic Artifacts ...........................................................................................................112
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About This Manual
To obtain a printed copy of this manual at no additional cost, contact Clarius at
www.clarius.me/contact-us.
This document is licensed as part of the purchase of the Clarius Ultrasound Scanner and meets
international regulatory requirements such as the FDA. Use of this document by unauthorized
persons is strictly prohibited.
This document contains the following information:
• About the Clarius Ultrasound Scanner: Describes the product, lists technical specifications,
and its intended use.
• A Quick Tour: Shows you how to get started and begin scanning.
• Using the Clarius Ultrasound Scanner: Introduces you to the features and concepts, helps
you set up your system, and explains the tasks you can perform.
• Cleaning & Disinfecting: Explains how to clean and disinfect your scanner.
• 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.
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Document Conventions
Touch Gestures
Gesture
Software Version 2.1.1
Title of
gesture
Description
Drag
Touch the screen with a finger and move the finger across the screen without
lifting the finger.
Double tap
Touch the screen briefly twice with the same finger.
Pinch
Touch the screen with two fingers and move them toward each other.
Tap
Touch a control with your finger.
Press and hold
Touch the screen for a short time without moving your finger.
Spread
Touch the screen with two fingers and move them apart.
Swipe
Touch the screen with your finger and move the finger in a quick motion right,
left, up, or down.
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Clarius Ultrasound Scanner
Icons
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.
Symbols
You may see some of these symbols on your Clarius product, accessories, and packaging:
Symbol
Software Version 2.1.1
Title of
Symbol
Description
Manufacturer
Indicates the medical device manufacturer, as defined in EU Directives 90/385/
EEC, 93/42/EEC and 98/79/EC.
Authorized
representative in
the European
Community
Indicates the Authorized representative in the European Community.
Date of
manufacture
Indicates the date when the medical device was manufactured.
Use-by date
Indicates the date after which the medical device is not to be used.
Batch code
Indicates the manufacturer's batch code so that the batch or lot can be identified.
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Catalogue
number
Indicates the manufacturer's catalogue number so that the medical device can
be identified.
Serial number
Indicates the manufacturer's serial number so that a specific medical device can
be identified.
Sterile
Indicates a medical device that has been subjected to a sterilization process.
Sterilized using
aseptic
processing
techniques
Indicates a medical device that has been manufactured using accepted aseptic
techniques.
Sterilized using
ethylene oxide
Indicates a medical device that has been sterilized using ethylene oxide.
Sterilized using
irradiation
Indicates a medical device that has been sterilized using irradiation.
Sterilized using
steam or dry
heat
Indicates a medical device that has been sterilized using steam or dry heat.
Do not resterilize
Indicates a medical device that is not to be resterilized.
Non-sterile
Indicates a medical device that has not been subjected to a sterilization process.
Do not use if
package is
damaged
Indicates a medical device that should not be used if the package has been
damaged or opened.
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Sterile fluid path
Indicates the presence of a sterile fluid path within the medical device in cases
when other parts of the medical device, including the exterior, might not be
supplied sterile.
Fragile, handle
with care
Indicates a medical device that can be broken or damaged if not handled
carefully.
Keep away from
sunlight
Indicates a medical device that needs protection from light sources.
Protect from
heat and
radioactive
sources
Indicates a medical device that needs protection from heat and radioactive
sources.
Keep dry
Indicates a medical device that needs to be protected from moisture.
Lower limit of
temperature
Indicates the lower limit of temperature to which the medical device can be
safely exposed.
Upper limit of
temperature
Indicates the upper limit of temperature to which the medical device can be
safely exposed.
Temperature
limit
Indicates the temperature limits to which the medical device can be safely
exposed.
Humidity
limitation
Indicates the range of humidity to which the medical device can be safely
exposed.
Atmospheric
pressure
limitation
Indicates the range of atmospheric pressure to which the medical device can be
safely exposed.
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Biological risks
Indicates that there are potential biological risks associated with the medical
device.
Do not re-use
Indicates a medical device that is intended for one use, or for use on a single
patient during a single procedure.
Consult
instructions for
use
Indicates the need for the user to consult the instructions for use.
Refer to
instruction
manual/booklet.
Indicates to read the instruction manual/booklet before starting work or before
operating equipment or machinery.
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.
Contains or
presence of
natural rubber
latex
Indicates the presence of natural rubber or dry natural rubber latex as a material
of construction within the medical device or the packaging of a medical device.
In vitro
diagnostic
medical device
Indicates a medical device that is intended to be used as an in vitro diagnostic
medical device.
Control
Indicates a control material that is intended to verify the performance
characteristics of another medical device.
Negative control
Indicates a control material that is intended to verify the results in the expected
negative range.
Positive control
Indicates a control material that is intended to verify the results in the expected
positive range.
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Contains
sufficient for <n>
tests
Indicates the total number of IVD tests that can be performed with the IVD kit
reagents.
For IVD
performance
evaluation only
Indicates an IVD device that is intended to be used only for evaluating its
performance characteristics before it is placed on the market for medical
diagnostic use.
Sampling site
Indicates a medical device or blood processing application that includes a
system dedicated to the collection of samples of a given substance stored in the
medical device or blood container.
Fluid path
Indicates the presence of a fluid path.
Non-pyrogenic
Indicates a medical device that is non-pyrogenic.
Drops per
millilitre
Indicates the number of drops per millilitre.
Liquid filter with
pore size
Indicates an infusion or transfusion system of the medical device that contains a
filter of a particular nominal pore size.
One-way valve
Indicates a medical device with a valve that allows flow in only one direction.
Patient number
Indicates a unique number associated with an individual patient.
Type BF applied
part
To identify a type BF applied part complying with IEC 60601-1.
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Class II
equipment
To identify equipment meeting the safety requirements specified for Class II
equipment according to IEC 60536.
For indoor use
only
To identify electrical equipment designed primarily for indoor use.
RoHS compliant
To identify electrical and electronic equipment that meets the Restriction of
Hazardous Substances (RoHS) Directive 2011/65/EU.
European
Conformity
Conforms to European Council Directive 93/42/EEC.
Recyclable
material
To indicate that the marked item or its material is part of a recovery or recycling
process.
Waste Electrical
and Electronic
Equipment
Requires separate collection for electrical and electronic equipment in
compliance with the Waste Electrical and Electronic Equipment (WEEE).
Ingress
protection rating
The equipment inside the enclosure is protected from tools and wires greater
than 2.5 millimeters, and is also protected from immersion up to 1 meter in depth
for 30 minutes.
Global Medical
Device
Nomenclature
Code
A system of internationally agreed generic descriptors used to identify all
medical device products.
Global Trade
Item Number
An identifier to look up product information in a database, often by entering the
number through a bar code scanner pointed at an actual product.
Model name
Model name for the device.
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.
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About the Clarius
Ultrasound Scanner
1
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
devices to reduce the possibility of causing interference to
radios, televisions, and other electronic devices.
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Clarius Ultrasound Scanner
Scanner Description
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 COTS (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 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.
Battery manufacturer
Clarius
Battery model number
50-02-00012
Battery chemistry
Li-ion
Battery management
JEITA guideline compatible charger, in-pack fuel gauge with protection circuitry,
cell balancing, and temperature monitoring
Battery life
500 - 1000 discharge cycles before reduction in charge
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
• Clarius App
• Scanners:
• C3: convex scanner, 192 elements
• L7: linear scanner, 192 elements
The concept of the Clarius Ultrasound Scanner and software is primarily to provide an easy to
use, high-performance, low-cost, ultrasound platform for teaching and clinical applications.
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Clarius Ultrasound Scanner
Scanner Dimensions
Scanner Dimensions
Item
Length (in/mm)
Width (in/mm)
Height (in/mm)
Weight (oz/g)
Scanner (without
battery, with L7 front
piece)
6.7 in/169 mm
4.1 in/105 mm
1.6 in/41 mm
15.4 oz/437 g
Battery
2.8 in/70 mm
3.0 in/75 mm
0.7 in/17 mm
3.6 oz/103 g
Battery charger
(without plug adapter)
3.2 in/80 mm
3.5 in/89 mm
1.3 in/32 mm
1.9 oz/55 g
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Clarius Ultrasound Scanner
Product Usage
Product Usage
Indications for Use
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and
accessories intended for use in Point-of-Care Imaging of Medical Conditions on the general
public.
Point-of-Care clinical applications include:
• Emergency triage exam to look at trauma conditions
• Procedure guidance to guide needles into the body; and
• Other targeted diagnostic and measurement applications: fetal, fetal echo, abdominal,
small organ, musculo-skeletal (conventional), musculo-skeletal (superficial), urology,
gynecology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid
• The Clarius Ultrasound Scanner is intended for use in environments where healthcare is
provided by trained medical professionals. The device is not intended for use in
emergency medical service, ambulance, or aircraft.
Users will be trained medical professionals (e.g., doctors, nurses, technicians).
Targeted specialties shall include; Emergency Medicine, Anesthesia, Medical School Education,
and Veterinary applications.1
1. Not applicable in US.
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Product Usage
DEVICE NAME: 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)
B
Ophthalmic
Ophthalmic
Fetal Imaging & Other
Fetal
N
Abdominal
N
M
PWD
CWD
Color
Doppler
Combined
(Specify)
Other*
Intra-operative (Neuro)
Laparoscopic
Pediatric
N
Small Organ (Thyroid, Prostate,
Scrotum, Breast)
N
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)
N
Musculo-skeletal (Superficial)
N
Intravascular
Cardiac
Other (Urology, Gynecology)
N
Cardiac Adult
N
Cardiac Pediatric
N
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Peripheral Vessel
Software Version 2.1.1
Other (Fetal Echo)
N
Peripheral Vessel
N
Other (Cartoid)
N
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Clarius Ultrasound Scanner
Product Usage
DEVICE NAME: CLARIUS ULTRASOUND SCANNER
INTENDED USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:
N = new indication; P = previously cleared by FDA; E = added under this appendix
* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion
Doppler, and Color Velocity Imaging
Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical
structures and imaging guidance for nerve block procedures.
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Clarius Ultrasound Scanner
Product Usage
DEVICE NAME: C3 CONVEX 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)
B
Ophthalmic
Ophthalmic
Fetal Imaging & Other
Fetal
N
Abdominal
N
M
PWD
CWD
Color
Doppler
Combined
(Specify)
Other*
Intra-operative (Neuro)
Laparoscopic
Pediatric
N
Small Organ (Thyroid, Prostate,
Scrotum, Breast)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)
N
Musculo-skeletal (Superficial)
Intravascular
Cardiac
Other (Urology, Gynecology)
N
Cardiac Adult
Na
Cardiac Pediatric
Na
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (Fetal Echo)
N
Peripheral
Peripheral Vessel
N
Vessel
Other (Cartoid)
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Product Usage
DEVICE NAME: C3 CONVEX SCANNER
INTENDED USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:
N = new indication; P = previously cleared by FDA; E = added under this appendix
* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion
Doppler, and Color Velocity Imaging
Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical
structures and imaging guidance for nerve block procedures.
a. Not applicable in US.
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Clarius Ultrasound Scanner
Product Usage
SYSTEM: L7: LINEAR 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)
Ophthalmic
Ophthalmic
Fetal Imaging & Other
Fetal
Abdominal
B
M
PWD
CWD
Color
Doppler
Combined
(Specify)
Other*
N
Intra-operative (Neuro)
Laparoscopic
Pediatric
N
Small Organ (Thyroid, Prostate,
Scrotum, Breast)
N
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)
N
Musculo-skeletal (Superficial)
N
Intravascular
Other (Urology, Gynecology)
Cardiac
Cardiac Adult
N
Cardiac Pediatric
N
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (Fetal Echo)
Peripheral
Peripheral Vessel
N
Vessel
Other (Cartoid)
N
Software Version 2.1.1
17