User Manual
161 Pages
Preview
Page 1
Disclaimer: This disclaimer extends to all printed matter accompanying the Clarius Ultrasound Scanner. This manual is licensed under the Terms and Conditions available at clarius.com/terms. You may not use this manual except in compliance with the license. The information contained in these materials is proprietary and confidential to Clarius Mobile Health Corp. (“Clarius“) and is provided for the sole use of the individual or entity to whom it is addressed and therefore these materials must be kept in the strictest confidence. No portion of this manual may be copied, reproduced, republished, modified, sold, disclosed, or distributed without the prior written permission of Clarius. Unauthorized copying or distribution of this manual, in addition to infringing copyright, may reduce the ability of Clarius to provide updates and current information to users. Clarius has taken care to ensure the accuracy of this document, however, revisions may not be possible in all situations. Information in this document may be subject to change without notice, and Clarius assumes no liability for errors or omissions. Clarius reserves the right to make changes without further notice to any products herein to improve reliability, function, or design. Clarius may make improvements or changes in the products or programs described in this document at any time. These materials may contain third-party copyright and/or trademark materials, the use of which has not always been specifically authorized by the intellectual property owner. All copyrights and/or trademarks contained in these materials are the sole and exclusive property of their respective owners. “Clarius”, “Ultrasound Anywhere,” “Point-and-Shoot Ultrasound”, “Act One”, “Tri-Scanner”, “My New Stethoscope”, “It’s About the Image,” the Clarius logo, and the Clarius Live logo are trademarks or registered trademarks and are the sole and exclusive property of Clarius. Listing of applicable U.S. Patents in compliance with 35 U.S.C. s. 287: www.clarius.com/patents. All names used in Clarius (whether online, in print, or any other media) are fictitious and are used herein for the purposes of example and demonstration on how to use the Clarius Ultrasound Scanner. Any similarity to real people is a coincidence. © 2024 Clarius Mobile Health Corp. All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means, electronic, mechanical, or otherwise, is prohibited without the prior written consent of the copyright owner. Published in Canada. 15-03-00118
Table of Contents About This Manual ... 1 Intended Users ...2 Document Conventions ...2
1.
About the Clarius Ultrasound Scanner ... 6 Device Description...7 Product Dimension ...8 Product Usage ...8 Indications for Use...8 Intended Patient Population...9 Precautions ...19
Hardware ...20 Warranty ...20 Disposal ...20
Security ...20 Information Security...20 Network Security ...21 Confidentiality...21 Integrity ...22 Availability...22 Accountability ...22
System Requirements...23
2.
Using the Clarius Ultrasound Scanner ... 24 Downloading the Clarius App ...24 Turning the System on & off ...25 Starting the Clarius App ...25 Exiting the Clarius App...25
Imaging ...25 Start Scanning ...25 Scanner Notifications ...27
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Clarius Scanner HD3
Voice Controls ... 28 Start Voice Controls ... 28 Turn off Voice Controls ... 29 Voice Command Dictionary ... 29
Updating the Clarius Ultrasound Scanner ... 29 Software Updates ... 29 Firmware Updates ... 29
Maintenance... 30 Hardware Maintenance ... 30 System Maintenance ... 30
3.
Accessories... 32 Clarius Charger HD3... 32 About the Clarius Charger HD3... 32 Setting Up the Clarius Charger HD3 ... 34
Clarius Power Fan HD3... 34 About the Clarius Power Fan HD3... 35 Charging the Clarius Scanner HD3 ... 35
4.
Cleaning & Disinfecting ... 37 Cleaning ... 38 Cleaning the Clarius Scanner HD3 ... 38 Cleaning the Clarius Power Fan HD3... 39 Cleaning the Clarius Micro USB Cable ... 39 Cleaning the Clarius Charger HD3... 39
Disinfecting ... 40 Disinfecting the Clarius Scanner HD3 ... 40 Disinfecting the Clarius Power Fan HD3 ... 41 Disinfecting the Clarius Micro USB Cable ... 41 Disinfecting the Clarius Charger HD3 ... 42
Spaulding Classification ... 42
5.
Safety... 43 About Diagnostic Ultrasounds... 43 Interactions with Matter... 43 Studies... 43 Benefits & Risks... 44
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Clarius Scanner HD3
Safety Topics ... 44 Product Safety... 45 Battery Safety... 46 Cleaning Safety ... 46 Clinical Safety... 49 Biological Safety ... 49 ALARA Principle ... 51 Fire & Electrical Safety... 61 Electromagnetic Safety ... 62
6.
References... 68 Compliance Statement ... 68 The Clarius Ultrasound Scanner ... 68 Product Classification ... 68 Product Serial Number ... 69 System Specifications ... 69 Environmental Specifications... 71 Scanner Specifications ... 72
Standards... 72 Chemical ... 72 Electrical Safety ... 73 Labeling ... 73 Quality... 73 Security & Privacy ... 75 Wireless ... 75
Cleaners & Disinfectants... 76 Cleaner & Disinfectant Usage... 76 Cleaner & Disinfectant Details ... 77
Glossary of Terms ... 77 Known Issues... 77
7.
Measurement Accuracy Tables ... 78 Clarius Scanner C3 HD3 ... 79 Clarius Scanner C7 HD3 ... 80 Clarius Scanner EC7 HD3 ... 81 Clarius Scanner L7 HD3 ... 82 Clarius Scanner L15 HD3 ... 83 Clarius Scanner L20 HD3 ... 84 Clarius Scanner PA HD3 ... 85
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Clarius Scanner HD3
Clarius Scanner PAL HD3 (Linear Array) ... 86 Clarius Scanner PAL HD3 (Phased Array) ... 87
Acoustic Output Tables ... 88 Clarius Scanner C3 HD3: B-Mode ... 88 Clarius Scanner C3 HD3: Color Doppler Mode ... 89 Clarius Scanner C3 HD3: M-Mode ... 90 Clarius Scanner C3 HD3: PW Doppler Mode ... 91 Clarius Scanner C7 HD3: B-Mode ... 92 Clarius Scanner C7 HD3: Color Doppler Mode ... 93 Clarius Scanner C7 HD3: M-Mode ... 94 Clarius Scanner C7 HD3: PW Doppler Mode ... 95 Clarius Scanner EC7 HD3: B-Mode ... 96 Clarius Scanner EC7 HD3: Color Doppler Mode ... 97 Clarius Scanner EC7 HD3: M-Mode ... 98 Clarius Scanner EC7 HD3: PW Doppler Mode ... 99 Clarius Scanner L7 HD3: B-Mode ... 100 Clarius Scanner L7 HD3: Color Doppler Mode ... 101 Clarius Scanner L7 HD3: M-Mode ... 102 Clarius Scanner L7 HD3: Needle Enhance B-Mode ... 103 Clarius Scanner L7 HD3: Ocular (Ophthalmic) B-Mode ... 104 Clarius Scanner L7 HD3: PW Doppler Mode ... 105 Clarius Scanner L15 HD3: B-Mode ... 106 Clarius Scanner L15 HD3: Color Doppler Mode ... 107 Clarius Scanner L15 HD3: M-Mode ... 108 Clarius Scanner L15 HD3: Needle Enhance B-Mode ... 109 Clarius Scanner L15 HD3: Ocular (Ophthalmic) B-Mode ... 110 Clarius Scanner L15 HD3: PW Doppler Mode ... 111 Clarius Scanner L20 HD3: B-Mode ... 112 Clarius Scanner L20 HD3: Color Doppler Mode ... 113 Clarius Scanner L20 HD3: M-Mode ... 114 Clarius Scanner L20 HD3: Needle Enhance B-Mode ... 115 Clarius Scanner L20 HD3: Ocular (Ophthalmic) B-Mode ... 116 Clarius Scanner L20 HD3: PW Doppler Mode ... 117 Clarius Scanner PA HD3: B-Mode ... 118 Clarius Scanner PA HD3: Color Doppler Mode ... 119 Clarius Scanner PA HD3: M-Mode ... 120 Clarius Scanner PA HD3: PW Doppler Mode ... 121 Clarius Scanner PA HD3: Transcranial B-Mode ... 122 Clarius Scanner PA HD3: Transcranial Color Doppler Mode ... 123 Clarius Scanner PA HD3: Transcranial M-Mode ... 124 Clarius Scanner PA HD3: Transcranial PW Doppler Mode ... 125 Clarius Scanner PAL HD3: B-Mode, Linear Array ... 126 Clarius Scanner PAL HD3: Color Doppler Mode, Linear Array ... 127 Clarius Scanner PAL HD3: M-Mode, Linear Array ... 128
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Clarius Scanner HD3
Clarius Scanner PAL HD3: Needle Enhance B-Mode, Linear Array ... 129 Clarius Scanner PAL HD3: Ocular (Ophthalmic) B-Mode, Linear Array ... 130 Clarius Scanner PAL HD3: PW Doppler Mode, Linear Array ... 131 Clarius Scanner PAL HD3: B-Mode, Phased Array ... 132 Clarius Scanner PAL HD3: Color Doppler Mode, Phased Array ... 133 Clarius Scanner PAL HD3: M-Mode, Phased Array ... 134 Clarius Scanner PAL HD3: PW Doppler Mode, Phased Array ... 135
Clarius AI User Guide... 136 1.
About Clarius MSK AI ... 137 Indications for Use... 137 Note to User – Scanners & Presets for MSK ... 137 Note to User – Auto Hiding Controls ... 137 Note to User – Imaging Artifacts, Performance, & Limitations... 138
How to Use Clarius MSK AI... 139
2.
About Clarius Bladder AI ... 145 Indications for Use... 145 Note to User – Scanners & Presets for Bladder ... 145 Note to User – Auto Hiding Controls ... 145 Note to User – Imaging Artifacts, Performance, & Limitations... 146 Note to User - Performance Specifications of Clarius Bladder AI & Measurement Output Information ... 146
How to Use Clarius Bladder AI ... 147
Revision History... 153
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About This Manual
To obtain a printed copy of this manual at no additional cost, go to clarius.com/contact and contact Clarius. This manual provides instructions for use on the Clarius Ultrasound Scanner - HD3 Scanners family of ultrasound scanners. For models that are not HD3, refer to the appropriate user manual at clarius.com/manuals. This document is licensed as part of the purchase of the Clarius Ultrasound Scanner and meets applicable regulatory requirements. Use of this document by unauthorized persons is strictly prohibited. This document contains the following information: • About the Clarius Ultrasound Scanner: Describes the product, and lists technical specifications, and its intended use. • Using the Clarius Ultrasound Scanner: Shows you how to get started and begin scanning, introduces you to the features and concepts, and helps you set up your system. • Accessories: Describes additional accessories you can purchase for use with your Clarius Ultrasound Scanner - HD3 Scanners. • Cleaning & Disinfecting: Explains how to clean and disinfect your scanner and its accessories. • Safety: Outlines important safety standards, principles, and policies to follow when using the product. • References: Offers information such as product standards and regulatory requirements. • Measurement Accuracy Tables: Displays the measurement accuracy and Doppler sensitivity of each scanner and mode. • Acoustic Output Tables: Displays acoustic data for each scanner and mode. • Revision History: Displays a historic list of changes made to this document.
Access to user documentation may be affected by: Internet availability and accessibility, website availability, and local electromagnetic interference.
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Clarius Scanner HD3
Intended Users This user manual is written for trained medical professionals who use the Clarius Ultrasound Scanner. It contains instructions and reference material pertaining to the usage and maintenance of the device. This document does not provide training in sonography, ultrasound, or clinical practices.
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 60417, and (EN) ISO 15223-1.
STANDARD: ISO 15223-1 - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS Symbol
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Reference Title
Description
3082
Manufacturer
Indicates the medical device manufacturer.
2497
Date of manufacture
Indicates the date when the medical device was manufactured.
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Clarius Scanner HD3
STANDARD: ISO 15223-1 - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS Symbol
Reference Title
Description
2493
Catalogue number
Indicates the manufacturer's catalogue number so that the medical device can be identified.
2609
Non-sterile
Indicates a medical device that has not been subjected to a sterilization process.
0621
Fragile; handle with care
Indicates a medical device that can be broken or damaged if not handled carefully.
0626
Keep dry
Indicates a medical device that needs to be protected from moisture.
0632
Temperature limit
Indicates the temperature limits to which the medical device can be safely exposed.
0224
Humidity limitation
Indicates the range of humidity to which the medical device can be safely exposed.
1641
Indicates the need for the user to consult the instructions for use. Consult instructions for use or consult electronic instructions for use
0434A
Caution
Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequence.
1135
General symbol for recovery/recyclable
To indicate that the marked item or its material is part of a recovery or recycling process.
You may see some of these standard symbols on your Clarius Scanner HD3, accessories, and packaging:
OTHER STANDARDS - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS Symbol
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Standard
Reference Title
Description
ISO 7010
M002
Refer to instruction manual/booklet
Indicates to read the instruction manual/booklet before starting work or before operating equipment or machinery.
IEC 60417
5172
Class II equipment
To identify equipment meeting the safety requirements specified for Class II equipment according to IEC 60536.
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Clarius Scanner HD3
OTHER STANDARDS - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS Symbol
Standard
Reference Title
Description
IEC 60417
5957
For indoor use only
To identify electrical equipment designed primarily for indoor use.
IEC 60417
5333
Type BF applied part
To identify a type BF applied part complying with IEC 60601-1.
You may see these other symbols on your Clarius Scanner HD3, 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 Medical Device Regulation 2017/745.
FCC
Conforms to US Federal Communications Commission.
CSA certification
Certified by the Canadian Standards Association. The number below this symbol indicates the contract number.
Waste Electrical and Electronic Equipment
Requires separate collection for electrical and electronic equipment in compliance with the Waste Electrical and Electronic Equipment (WEEE) Directive. When accompanied by or , components of the device may contain lead or mercury, respectively, which must be recycled or disposed of in accordance with local, state, or federal laws. The backlight lamps in an LCD system monitor contain mercury.
Ingress protection rating
The equipment inside the enclosure is protected from tools and wires greater than 1.0 millimeters, is dust-tight, and is also protected from immersion up to 1 meter in depth for 30 minutes.
DC
Direct current.
GS1 DataMatrix
Identifies GS1 encoded DataMatrix.
Global Medical Device Nomenclature Code
A system of internationally agreed generic descriptors used to identify all medical device products.
Authorized representative in Indicates the Authorized representative in the European Community. the European Community Authorized representative in Indicates the authorized representative in Switzerland. Switzerland
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Clarius Scanner HD3
OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT Symbol
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Title
Description
n/a
Do not stack boxes.
n/a
Do not use knife to open.
n/a
Recycle scanner in accordance with local, state, and federal regulation.
Medical Device
European Medical Device Regulation 2017/745.
Rx Only
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
5
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 user manual in conjunction with sound clinical judgment and standard POCUS practices. This product is subject to the law in the jurisdiction that the product is used. Install, use, and operate the product only in ways that adhere to applicable laws or regulations, which have the force of law. This device complies with part 15 of the FCC rules and Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.1
• Product package must be maintained with medical device. Do not dispose. • Using the product incorrectly, or for purposes other than those intended and expressly stated by Clarius, may relieve Clarius or its agents from all or some responsibility for resultant noncompliance, damage, or injury. • Using portable and mobile radio frequency (RF) communications equipment can affect the operation of medical equipment. • Operating this system in the presence of flammable gases or anesthetics can cause an explosion.
1. Le présent appareil est conforme avec la section 15 des règlementations FCC ainsi qu'aux standards CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire d'interférence, et (2) l'appareil doit accepter toute interférence radioélectrique subi, même si l'interférence est susceptible d'en compromettre le fonctionnement.
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Clarius Scanner HD3
Device Description
• Install and operate medical equipment according to electromagnetic compatibility (EMC) guidelines. • Users are responsible for image quality and diagnosis. • This product has demonstrated EMC compliance under conditions that included the use of compliant peripheral devices. It is important that you use compliant peripheral devices to reduce the possibility of causing interference to radios, televisions, and other electronic devices. • Circumstances in the patient’s environment may negatively impact the scanner and the exam. For example: (1) Chemicals and gases in the operating room. (2) Altitudes below -382 m or above 4000 m. • Vulnerable patients, such as children and pregnant/nursing women, may be more prone to the exposure of acoustic energy when the scanner is used for prolonged periods. • Biological incompatibility may exist between the scanner materials used and the biological tissues, cells, and body fluids of the patient/user, taking account of the intended purpose of the scanner. • Using the scanner in the patient environment may be unsafe if the following conditions exist: (1) Extremes in humidity (RH<15% and RH>95%). (2) Ambient temperatures that are excessively high (>40°C / 104°F) or excessively low (<-20°C / -4°F). • Unqualified/untrained personnel purchasing and using the Clarius Scanner HD3 may be unable to attain quality images. • Each Clarius Scanner HD3 contains a Li-ion battery. Treat the battery with precaution.
Users should be trained medical professionals (e.g., doctors, nurses, technicians) with previous training in ultrasound. Images produced by the scanner are transmitted wirelessly to the user’s smart device (tablet or smart phone).
Device Description For regulatory information in e-labeling format, open the Clarius App and go to the About page. The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) Apple iOS or Android™ device. The Clarius Ultrasound Scanners are Bluetooth and wireless, and communicate with traditional tablets/ smartphones via direct Wi-Fi to allow users to export ultrasound images and display in different modes of operation. The Clarius Scanner HD3 houses a battery and internal power supplies, multichannel beamformer, prescan converter, and Wi-Fi components. The Clarius Scanner HD3 is supplied with a charger. The system is a transportable ultrasound system intended for use in rotary-wing air ambulances, road ambulances, and emergency medical service (EMS) environments where
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Clarius Scanner HD3
Product Dimension
healthcare is provided by trained healthcare professionals. The EC7 HD31 and the Clarius Charger HD31 should be used in a stationary setting.
Product Dimension
Item
Length (in/mm)
Width (in/mm)
Thickness (in/mm)
Weight (oz/g)
Clarius Scanner C3 HD3 (CIDN 99-13-00018)
5.7/146
3.0/76
1.3/32
10.9/308
Clarius Scanner C7 HD3 (CIDN 99-13-00019)
5.9/151
3.0/76
1.3/32
10.2/289
Clarius Scanner EC7 HD3 (CIDN 99-13-00024)
12.2/310
3.0/76
1.3/32
11.5/326
Clarius Scanner L7 HD3 (CIDN 99-13-00020)
5.8/147
3.0/76
1.3/32
10.2/288
Clarius Scanner L15 HD3 (CIDN 99-13-00021)
5.8/147
3.0/76
1.3/32
10.2/290
Clarius Scanner L20 HD3 (CIDN 99-13-00022)
5.8/147
3.0/76
1.3/32
10.2/290
Clarius Scanner PA HD3 (CIDN 99-13-00023)
5.8/148
3.0/76
1.3/32
10.3/292
Clarius Scanner PAL HD3 (CIDN 99-13-00029)
5.8/148
3.0/76
1.3/32
10.8/307
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: ophthalmic2 , fetal, abdominal, intraoperative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, transvaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
1. Not intended for EMS environment. 2. Only applicable to the L7 HD3, L15 HD3, L20 HD3, & PAL HD3 scanners.
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Product Usage
Intended Patient Population The system is intended for use for diagnostic ultrasound imaging and fluid flow analysis of anatomical structures and fluids of adult and pediatric patients.
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Clarius Scanner HD3
Product Usage
Indications for Use Tables Clarius Ultrasound Scanner HD3
SYSTEM: CLARIUS ULTRASOUND SCANNER HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application
Mode of Operation
General (Track 1 Only)
Specific (Tracks 1 & 3)
B M Color Power PW Combined (Specify) Doppler Doppler Doppler
Ophthalmic
Ophthalmic
Fetal Imaging & Other
Fetal
B+M; B+CD; B+PD; B+PWD Note 1
Abdominal
B+M; B+CD; B+PD; B+PWD Note 1
Intra-operative (Abdominal organs & vascular)
B+M; B+CD; B+PD; B+PWD Note 1
Pediatric
B+M; B+CD; B+PD; B+PWD Note 1
Small Organ (Thyroid, Prostate, Scrotum, Breast)
B+M; B+CD; B+PD; B+PWD Note 1
Neonatal Cephalic
B+M; B+CD; B+PD; B+PWD Note 1
Adult Cephalic
B+M; B+CD; B+PD; B+PWD Note 1
Trans-rectal
B+M; B+CD; B+PD; B+PWD
Trans-vaginal
B+M; B+CD; B+PD; B+PWD
Musculo-skeletal (Conventional)
B+M; B+CD; B+PD; B+PWD Note 1
Musculo-skeletal (Superficial)
B+M; B+CD; B+PD; B+PWD Note 1
Other (Urology, Gynecology)
B+M; B+CD; B+PD; B+PWD
Cardiac Adult
B+M; B+CD; B+PD; B+PWD Note 1
Cardiac Pediatric
B+M; B+CD; B+PD; B+PWD Note 1
B+M; B+CD; B+PD; B+PWD Note 1
B+M; B+CD; B+PD; B+PWD Note 1
Other*
Laparoscopic
Trans-urethral Trans-esophageal (non-Cardiac)
Intravascular Cardiac
Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (specify) Peripheral Vessel Peripheral Vessel Other (Carotid) Note 1: Needle Enhancement in B-Mode.
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Product Usage
Clarius Scanner C3 HD3
DEVICE NAME: CLARIUS SCANNER C3 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application
Mode of Operation
General (Track 1 Only)
B M Color Power PW Combined (Specify) Doppler Doppler Doppler
Specific (Tracks 1 & 3)
Ophthalmic
Ophthalmic
Fetal Imaging & Other
Fetal
B+M; B+CD; B+PD; B+PWD
Abdominal
B+M; B+CD; B+PD; B+PWD
Intra-operative (Abdominal organs & vascular)
B+M; B+CD; B+PD; B+PWD
B+M; B+CD; B+PD; B+PWD
B+M; B+CD; B+PD; B+PWD
B+M; B+CD; B+PD; B+PWD
Other (Urology, Gynecology)
B+M; B+CD; B+PD; B+PWD
Cardiac Adult
B+M; B+CD; B+PWD
Cardiac Pediatric
B+M; B+CD; B+PWD
B+M; B+CD; B+PD; B+PWD
Other*
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
Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (specify) Peripheral Vessel Peripheral Vessel
Other (Carotid)
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Clarius Scanner HD3
Product Usage
Clarius Scanner C7 HD3
DEVICE NAME: CLARIUS SCANNER C7 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application
Mode of Operation
General (Track 1 Only)
Specific (Tracks 1 & 3)
B M Color Power PW Combined (Specify) Doppler Doppler Doppler
Ophthalmic
Ophthalmic
Fetal Imaging & Other
Fetal
B+M; B+CD; B+PD; B+PWD
Abdominal
B+M; B+CD; B+PD; B+PWD
Intra-operative (Abdominal organs & vascular)
B+M; B+CD; B+PD; B+PWD
Pediatric
B+M; B+CD; B+PD; B+PWD
Small Organ (Thyroid, Prostate, Scrotum, Breast)
B+M; B+CD; B+PD; B+PWD
B+M; B+CD; B+PD; B+PWD
Other (Urology, Gynecology)
B+M; B+CD; B+PD; B+PWD
Cardiac Adult
B+M; B+CD; B+PD; B+PWD
Cardiac Pediatric
B+M; B+CD; B+PWD
B+M; B+CD; B+PD; B+PWD
Other*
Laparoscopic
Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esophageal (non-Cardiac) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Cardiac
Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (specify) Peripheral Vessel Peripheral Vessel
Other (Carotid)
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Product Usage
Clarius Scanner EC7 HD3
DEVICE NAME: CLARIUS SCANNER EC7 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application
Mode of Operation
General (Track 1 Only)
B M Color Power PW Combined (Specify) Doppler Doppler Doppler
Specific (Tracks 1 & 3)
Ophthalmic
Ophthalmic
Fetal Imaging & Other
Fetal
B+M; B+CD; B+PD; B+PWD
Abdominal
B+M; B+CD; B+PD; B+PWD
B+M; B+CD; B+PD; B+PWD
Trans-rectal
B+M; B+CD; B+PD; B+PWD
Trans-vaginal
B+M; B+CD; B+PD; B+PWD
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)
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Clarius Scanner HD3
Product Usage
Clarius Scanner L7 HD3
DEVICE NAME: CLARIUS SCANNER L7 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application
Mode of Operation
General (Track 1 Only)
Specific (Tracks 1 & 3)
B M Color Power PW Combined (Specify) Doppler Doppler Doppler
Ophthalmic
Ophthalmic
Fetal Imaging & Other
Fetal
Other*
Abdominal
B+M; B+CD; B+PD; B+PWD Note 1
Intra-operative (Abdominal organs & vascular)
B+M; B+CD; B+PD; B+PWD Note 1
Pediatric
B+M; B+CD; B+PD; B+PWD Note 1
Small Organ (Thyroid, Prostate, Scrotum, Breast)
B+M; B+CD; B+PD; B+PWD Note 1
Musculo-skeletal (Conventional)
B+M; B+CD; B+PD; B+PWD Note 1
Musculo-skeletal (Superficial)
B+M; B+CD; B+PD; B+PWD Note 1
B+M; B+CD; B+PD; B+PWD Note 1
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) Note 1: Needle Enhancement in B-Mode.
revision 12
14