Clarius User Manual Rev 11 Oct 2019.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 www.clarius.com/termsconditions. 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.
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
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Table of Contents
About This Manual ........................................................................................................ 1
Target Audience...................................................................................................................1
Document Conventions .....................................................................................................2
Chapter 1: About the Clarius Ultrasound Scanner .....................................5
Device Description .................................................................................................. 6
Scanner Dimensions................................................................................................ 7
Product Usage........................................................................................................... 8
Indications for Use .........................................................................................................8
Contraindications ...........................................................................................................14
Hardware.................................................................................................................... 15
Warranty...........................................................................................................................15
Disposal ............................................................................................................................15
Security ...................................................................................................................... 16
Information Security......................................................................................................16
Network Security ............................................................................................................16
Confidentiality ................................................................................................................17
Integrity ............................................................................................................................17
Availability.......................................................................................................................17
Accountability .................................................................................................................18
System Requirements............................................................................................. 18
Chapter 2: Using the Clarius Ultrasound Scanner......................................19
Downloading the Clarius App ............................................................................... 19
Turning the System on & off ................................................................................. 20
Starting the Clarius App................................................................................................20
Exiting the Clarius App..................................................................................................20
Inserting & Removing the Battery ....................................................................... 20
Inserting the Clarius Battery........................................................................................20
Removing the Battery....................................................................................................21
A Quick Tour .............................................................................................................. 21
Screen Overview ............................................................................................................21
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Clarius Ultrasound Scanner
Connecting Your Smart Device to the Clarius Scanner.........................................24
Managing Exams .......................................................................................................25
Error Messages ...............................................................................................................26
Imaging .......................................................................................................................27
Using the Measuring Tools ..........................................................................................27
Updating the Clarius Ultrasound Scanner ..........................................................28
Software Updates ..........................................................................................................28
Firmware Updates..........................................................................................................28
Maintenance ..............................................................................................................29
Hardware Maintenance.................................................................................................29
System Maintenance .....................................................................................................31
Chapter 3: Accessories ............................................................................. 32
Clarius Fan..................................................................................................................32
Chapter 4: Cleaning & Disinfecting .......................................................... 33
Cleaning......................................................................................................................34
Cleaning the Clarius Scanner ......................................................................................34
Cleaning the Fan ............................................................................................................35
Disinfecting................................................................................................................36
Disinfecting the Clarius Scanner ................................................................................36
Disinfecting the Fan ......................................................................................................37
Spaulding Classification .........................................................................................38
Chapter 5: Safety...................................................................................... 39
About Diagnostic Ultrasounds...............................................................................39
Interactions with Matter...............................................................................................39
Studies..............................................................................................................................39
Benefits & Risks..............................................................................................................40
Safety Topics .............................................................................................................40
Product Safety ................................................................................................................41
Battery Safety .................................................................................................................42
Cleaning Safety ..............................................................................................................43
Clinical Safety .................................................................................................................45
Biological Safety ............................................................................................................45
ALARA Principle ..............................................................................................................47
Fire & Electrical Safety .................................................................................................57
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Electromagnetic Safety ................................................................................................58
Chapter 6: References .............................................................................. 63
Compliance Statement............................................................................................63
The Clarius Ultrasound Scanner ............................................................................63
Product Classification ...................................................................................................63
Product Serial Number..................................................................................................63
System Specifications...................................................................................................64
Scanner Specifications .................................................................................................65
Standards....................................................................................................................66
Biocompatibility.............................................................................................................66
Chemical ..........................................................................................................................66
Electrical Safety..............................................................................................................66
Federal..............................................................................................................................67
Labeling............................................................................................................................67
Quality ..............................................................................................................................67
Security & Privacy..........................................................................................................69
Wireless............................................................................................................................69
Doppler Sensitivity ..................................................................................................69
Acoustic Output Tables ..........................................................................................71
Clarius Scanner C3: B-Mode & M-Mode ...................................................................71
Clarius Scanner C3: Color Doppler Mode ................................................................72
Clarius Scanner C3: Pulsed Wave Mode ..................................................................73
Clarius Scanner C7: B-Mode & M-Mode ...................................................................74
Clarius Scanner C7: Color Doppler Mode ................................................................75
Clarius Scanner C7: Pulsed Wave Mode ..................................................................76
Clarius Scanner EC7: B-Mode & M-Mode .................................................................77
Clarius Scanner EC7: Color Doppler Mode ..............................................................78
Clarius Scanner EC7: Pulsed Wave Mode ................................................................79
Clarius Scanner L7: B-Mode & M-Mode ...................................................................80
Clarius Scanner L7: Color Doppler Mode ................................................................81
Clarius Scanner L7: Pulsed Wave Mode ...................................................................82
Clarius Scanner L7: Needle Enhance Mode .............................................................83
Clarius Scanner L7: Ocular (Ophthalmic) Mode .....................................................84
Cleaners & Disinfectants ........................................................................................85
Cleaner & Disinfectant Usage.....................................................................................85
Cleaner & Disinfectant Details ...................................................................................86
Sterilization Systems ....................................................................................................86
Glossary of Terms .....................................................................................................86
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Clarius Ultrasound Scanner
Acoustic Outputs............................................................................................................87
Acoustic Artifacts ...........................................................................................................89
Known Issues .............................................................................................................92
Revision History........................................................................................................92
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About This Manual
To obtain a printed copy of this manual at no additional cost, go to www.clarius.com/contact
and contact Clarius.
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.
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Clarius Ultrasound Scanner
Document Conventions
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 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.
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.
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Clarius Ultrasound Scanner
STANDARD: ISO 7000 — GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT — REGISTERED SYMBOLS
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;
Indicates the need for the user to consult the instructions for use.
operating instructions
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.
You may see some of these standard symbols on your Clarius Scanner, accessories, and
packaging:
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.
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Clarius Ultrasound Scanner
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, 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 Indicates the Authorized representative in the European Community.
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
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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
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Clarius Ultrasound Scanner
Device Description
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.
Device 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 (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 houses a
battery and power generator, multichannel beamformer, prescan converter and Wi-Fi
components. The battery is removable and comes with a separate charger.
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Clarius Ultrasound Scanner
Scanner Dimensions
Battery manufacturer
Clarius
Battery chemistry
Li-ion
Battery management
JEITA guideline compatible charger, in-pack fuel gauge with protection circuitry, cell balancing, 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
Scanner Dimensions
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
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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 diagnostic imaging. It is indicated for diagnostic ultrasound imaging
and fluid flow analysis in the following applications: ophthalmic1 ,2 , fetal, abdominal, intraoperative (non-neurological), pediatric, small organ, cephalic (adult)2, trans-rectal3 , transvaginal3, 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.
2.
3.
4.
Only applicable to the L7 scanner.
US, Canada, EU, and Singapore only.
Only in countries where Clarius Scanner EC7 is available.
IEC 60601-1-12 is valid in North America only.
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Clarius Ultrasound Scanner
Product Usage
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)
B M Color
Power PW
Combined (Specify)
Doppler Doppler Doppler
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
Other*
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
Other (Urology, Gynecology)
P P P
P
P
B+M; B+CD; B+PD; B+PWD
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
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel
Other (Carotid)
P P P
P
P
B+M; B+CD; B+PD; B+PWD Note 1
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.
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Clarius Ultrasound Scanner
Product Usage
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)
B M Color
Power PW
Combined (Specify)
Doppler Doppler Doppler
Specific
(Tracks 1 & 3)
Ophthalmic
Ophthalmic
Fetal Imaging &
Other
Fetal
P P P
P
P
Other*
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
P P P
P
P
B+M; B+CD; B+PD; B+PWD
P P P
P
P
B+M; B+CD; B+PD; B+PWD
P P P
P
P
B+M; B+CD; B+PD; B+PWD
P
Laparoscopic
Pediatric
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Cardiac
Other (Urology, Gynecology)
P P P
P
B+M; B+CD; B+PD; B+PWD
Cardiac Adult
P P P
P
B+M; B+CD; B+PWD
Cardiac Pediatric
P P P
P
B+M; B+CD; B+PWD
P
B+M; B+CD; B+PD; B+PWD
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel
P P P
P
Other (Carotid)
N = new indication; P = previously cleared by FDA
Note 1: Needle Enhancement in B-Mode.
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Clarius Ultrasound Scanner
Product Usage
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)
B M Color
Power
PW
Combined (Specify)
Doppler Doppler Doppler
Ophthalmic
Ophthalmic
Fetal Imaging &
Other
Fetal
P P P
P
P
Other*
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
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
P P P
P
P
B+M; B+CD; B+PD; B+PWD
Laparoscopic
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Cardiac
Other (Urology, Gynecology)
P P P
P
P
B+M; B+CD; B+PD; B+PWD
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
P
B+M; B+CD; B+PD; B+PWD
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Peripheral Vessel Peripheral Vessel
P P P
P
Other (Carotid)
N = new indication; P = previously cleared by FDA
Note 1: Needle Enhancement in B-Mode.
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Clarius Ultrasound Scanner
Product Usage
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)
B M Color
Power PW
Combined (Specify)
Doppler Doppler Doppler
Specific
(Tracks 1 & 3)
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
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
P P P
P
P
B+M; B+CD; B+PD; B+PWD
Other*
Intra-operative
(Abdominal organs & vascular)
Laparoscopic
Pediatric
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
Neonatal Cephalic
Adult Cephalic
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Urology, Gynecology)
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.
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Clarius Ultrasound Scanner
Product Usage
Clarius Scanner L7
DEVICE NAME: CLARIUS SCANNER L7
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 M Color
Power PW
Combined (Specify)
Doppler Doppler Doppler
Ophthalmic
Ophthalmic
P
Fetal Imaging &
Other
Fetal
Other*
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
Pediatric
P P P
P
P
B+M; B+CD; B+PD
Note 1
Small Organ
(Thyroid, Prostate, Scrotum, Breast)
P
P
P
P
B+CD; B+PD; B+PWD
Note 1
Musculo-skeletal (Conventional)
P P P
P
P
B+M; B+CD; B+PD; B+PWD Note 1
Musculo-skeletal (Superficial)
P P P
P
P
B+M; B+CD; B+PD; B+PWD Note 1
P P P
P
P
B+M; B+CD; B+PD; B+PWD Note 1
P P P
P
P
B+M; B+CD; B+PD; B+PWD Note 1
Laparoscopic
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esophageal (non-Cardiac)
Intravascular
Other (Urology, Gynecology)
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.
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Product Usage
Contraindications
For Use in Surgical Environments
Before you use the Clarius Scanner for intra-operative procedures or in a surgical environment,
follow the instructions for high-level disinfection (for instructions see High-Level Disinfection
on page 37), then cover the Clarius Scanner with a sheath:
• Use only CIVCO REF 610-1212, Safersonic DAN-33803-WG, and Safersonic DAN-33803-NT.
• Follow the usage instructions provided by the manufacturer.
When you have finished using the Clarius Scanner, immediately clean it (for instructions see
Cleaning the Clarius Scanner on page 34), followed by another high-level disinfection.
If the sheath breaks during the intra-operative procedure, dispose the sheath and follow the
same cleaning and high-level disinfecting process as above, then cover the Clarius Scanner
with a new sheath before continuing to use it.
For Use in Endocavitary Procedures
Before using the Clarius Scanner for endocavitary procedures (trans-vaginal and/or transrectal), inspect the probe for any rough surfaces, sharp edges, or sharp corners that may cause
harm to the patient. Next, you must perform a high-level disinfection (for instructions see
High-Level Disinfection on page 37), then cover the Clarius Scanner EC7 with a model #2220
sheath by Protek Medical Supplies Inc. Make sure the entire length of the end piece is
protected.
When you have finished using the Clarius Scanner EC7, immediately clean it (for instructions
see Cleaning the Clarius Scanner on page 34), followed by another high-level disinfection. If a
Clarius Fan (CIDN 99-02-00028) was used, remove the fan prior to the high-level disinfection
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Clarius Ultrasound Scanner
Hardware
and follow the instructions for an intermediate-level disinfection (for instructions see
Disinfecting the Fan on page 37).
If the sheath breaks during an endocavitary procedure, dispose the sheath and follow the
same cleaning and high-level disinfecting process as above, then cover the Clarius Scanner
with a new sheath before continuing use.
When using a biopsy guide, use one of the following recommended products:
• Civco Reusable Endocavity Needle Guide (Product Number 613-198)
• Civco Disposable Endocavity Needle Guide (Product Numbers 667-089 and 667-090)
Follow the usage instructions provided by the manufacturer.
Do not reuse biopsy guides unless instructed by the manufacturer.
For Use in Ophthalmic Procedures
Using the Clarius Ultrasound Scanner for ophthalmic (ocular) indications is restricted to the
Clarius Scanner L7 in B-Mode. No other model should be used for this indication or for any use
causing the acoustic beam to pass through the eye. Doing so may result in serious and
irreversible harm to the eye of the patient.
Hardware
Warranty
Your Clarius Scanner includes a one-year warranty. For full warranty details, go to https://
support.clarius.com/hc/en-us/articles/360019549672-Warranty-Coverage.
To
purchase
extended warranty, go to www.clarius.com/contact and contact Clarius.
Disposal
Clarius is an active participant in the protection of the natural environment. The equipment
and its accessories are designed and manufactured according to environmental protection
guidelines, and the disposal of this equipment is intended to follow the same principles. The
equipment materials that are essential for functionality are also harmful to the natural
environment, therefore, you must dispose these materials appropriately.
For proper disposal of the Clarius Scanner or any of its accessories, dispose it in accordance
with local, state, and federal regulations. Alternatively, you can return it to Clarius.
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Clarius Ultrasound Scanner
Security
The improper disposal of the Clarius Scanner (when the battery is no longer working, or the
scanner has exceeded its shelf life), or any of its accessories, adds hazardous materials to our
landfills.
Security
Information Security
When entering data using the Clarius App, it is your responsibility to protect your security
credentials (e.g. passwords) and the personal information of patients (e.g. names). The user is
responsible for ensuring that patient health information is protected when using features in
the Clarius App that may expose identifying information to other viewers (e.g. Clarius Live).
Network Security
When connecting your smart device, use a network that supports Wi-Fi 802.11n. We
recommend that you secure this network using WPA (Wi-Fi Protected Access) or WPA2 (Wi-Fi
Protected Access II) as your security protocol.
For information on setting up your wireless network security, refer to your network
equipment’s documentation.
You may run into situations where no wireless access point is available. Using an untrusted
wireless access point may allow malicious parties to see your Wi-Fi signals, perform harmful
actions, and view communications between the two smart devices. When no secure access
point is available, operate the Clarius App in Wi-Fi Direct mode, and it will automatically set up
encryption.
For security purposes:
• Use secure passwords.
• Use secure wireless equipment using the latest firmware and software, and secure
protocols.
• Lock your smart devices.
The following actions could introduce new risks to patients, operators, and third parties. It is
your organization's responsibility to identify, analyze, evaluate, and control these risks:
• Changing network configurations.
• Connecting to additional networks or disconnecting from existing networks.
• Upgrading to new equipment or updating existing equipment.
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Security
Confidentiality
Confidentiality of information is assured as follows:
• The scanner contains no patient-identifying information.
• When the scanner connects to a wireless network, it encrypts and stores the Wi-Fi
password.
• The data transferred between the Clarius Scanner and the Clarius App is encrypted.
• Image data contains no patient- or user-identifying information, and is transmitted in
unencrypted form. If you want this data encrypted, connect to a:
• Wi-Fi network where only trusted parties are permitted. The Wi-Fi network
encrypts all image data sent from other Wi-Fi networks.
• Wi-Fi Direct network. The Wi-Fi Direct network encrypts all image data, and
because no other users are on the Wi-Fi Direct network, the image data is
confidential.
• If no images are exported to Clarius Cloud or DICOM, the Clarius App stores them in the
Clarius Scanner indefinitely. If images are exported, these images will be deleted from the
device 10 days after export by default. You can change this default in the Clarius App’s
Settings page.
Integrity
Integrity of the data transmitted between the Clarius Scanner and the Clarius App is assured as
follows:
• Authenticated encryption prevents malicious users from intercepting and modifying data.
• Integrity checks ensure completion and validity of data received. If any data is incomplete
or invalid, it is discarded.
• TCP channels used over Wi-Fi ensures that data is delivered correctly. For transmitting
image data, a UDP channel is used.
Availability
If Wi-Fi connection is unattainable (e.g. Wi-Fi access points are unavailable, or the network is
down), use Wi-Fi Direct network, which is managed by the smart device. Because Wi-Fi Direct
network is a peer-to-peer connection using the Wi-Fi protocol, it disallows other users from
connecting, thereby reducing DDOS (Distributed Denial of Service) attacks.
If the Wi-Fi Direct network is disrupted, the Clarius Scanner continues to monitor itself, and
shuts down after a period of inactivity. This reduces acoustic energy transmission and battery
usage.
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Clarius Ultrasound Scanner
System Requirements
Accountability
The concept of accountability does not apply to the Clarius Ultrasound Scanner. However,
ownership (i.e. the active user) of a smart device is assigned to one user at a time. Once you
begin using the smart device, no other user can connect to the same smart device. All data
transmitted between the smart device and the Clarius App is owned by the active user.
System Requirements
Using the Clarius Ultrasound Scanner on a smart device that does not meet the minimum
requirements may result in low-quality images, unexpected results, and possible misdiagnoses.
To run the Clarius App, a smart device must meet or exceed the following minimum
specifications:
Technical Features:
• Supports Bluetooth LE v4.0+
• Supports Wi-Fi 802.11n and Wi-Fi Direct
• 512 MB of memory
Operating System:
• Android™ 4.4.2 (API 19)+ or Apple iOS 9.1+
Processor:
• Dual core processor (CPU)
• ARM-based CPU architecture (for Android™-based devices)
Display:
• Resolution (in pixels) of 960x640 (or 640x960)
• Contrast ratio of 800:1
• Supports OpenGL ES 2.0
• Some sections of this User Manual may not apply to earlier versions of the Clarius
Ultrasound Scanner. Make sure you have the latest version of the Clarius App.
• Using a smart device that is too small may not have the necessary resolution for viewing
small structures.
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Using the Clarius
Ultrasound Scanner
2
This chapter explains how to install and use your Clarius Ultrasound
Scanner safely and effectively.
Refer to Safety on page 39 before handling the Clarius Ultrasound
Scanner.
Your Clarius Scanner is already activated and ready for use. You just
need to download the Clarius App on an Apple iOS device or an
Android™-based device.
Downloading the Clarius App
Whether you are using Apple iOS or Android™, you must have an
account and password set up with them.
Before installing the Clarius App, make sure your smart device meets
the minimum requirements. See System Requirements on page 18.
To download the Clarius App:
1.
Go to the Apple App Store or Google Play Store.
2. Search for the Clarius App.
If you cannot find the Clarius App, your smart device may
not be meeting minimum specifications.
3. Tap the Install button and follow the instructions on your
screen.
This downloads the application.
4. Tap the Open button.
This opens the Clarius App.
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