User Manual
120 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 www.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. 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. © 2021 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. 15-03-00064
Table of Contents About This Manual... 1 Target Audience ...2 Document Conventions ...2
Chapter 1: About the Clarius Ultrasound Scanner ... 6 Device Description...7 Product Dimension ...9 Product Usage ...9 Indications for Use...9 Precautions ...18
Hardware ...19 Warranty ...19 Disposal ...19
Security ...20 Information Security...20 Network Security ...20 Confidentiality...21 Integrity ...21 Availability...21 Accountability ...22
System Requirements...22
Chapter 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
Inserting & Removing the Battery ...25 Inserting the Clarius Battery HD ...25 Removing the Clarius Battery HD ...26
Imaging ...26 Start Scanning ...26
i
Clarius Ultrasound Scanner - HD Scanners
Scanner Notifications... 27 Using the Measuring Tools... 28
Updating the Clarius Ultrasound Scanner ... 31 Software Updates ... 31 Firmware Updates ... 31
Maintenance... 31 Hardware Maintenance ... 32 System Maintenance ... 34
Chapter 3: Accessories ... 35 Clarius Fan HD... 35 Clarius 2-in-1 Charging Station HD ... 36 Parts ... 37 Setting Up ... 38 Using the Clarius 2-in-1 Charging Station HD... 38 Maintenance... 39 Troubleshooting ... 40
Chapter 4: Cleaning & Disinfecting... 41 Cleaning ... 42 Cleaning the Clarius Scanner HD ... 42 Cleaning the Clarius Fan HD... 43 Cleaning the Clarius 2-in-1 Charging Station HD ... 43
Disinfecting ... 44 Disinfecting the Clarius Scanner HD ... 44 Disinfecting the Clarius Fan HD ... 45 Disinfecting the Clarius 2-in-1 Charging Station HD ... 46
Spaulding Classification ... 46
Chapter 5: Safety... 47 About Diagnostic Ultrasounds... 47 Interactions with Matter... 47 Studies... 47 Benefits & Risks... 48
Safety Topics ... 48 Product Safety... 49 Battery Safety... 50
revision 5.0
ii
Clarius Ultrasound Scanner - HD Scanners
Cleaning Safety ... 51 Clinical Safety... 53 Biological Safety ... 53 ALARA Principle ... 56 Fire & Electrical Safety... 65 Electromagnetic Safety ... 66
Chapter 6: References ... 71 Compliance Statement ... 71 The Clarius Ultrasound Scanner ... 71 Product Classification ... 71 Product Serial Number ... 72 System Specifications ... 72 Scanner Specifications ... 74
Standards... 74 Biocompatibility ... 74 Chemical ... 75 Electrical Safety ... 75 Labeling ... 75 Quality... 75 Security & Privacy ... 77 Wireless ... 77
Cleaners & Disinfectants... 78 Cleaner & Disinfectant Usage... 78 Cleaner & Disinfectant Details ... 79
Glossary of Terms ... 79 Known Issues... 80
Acoustic Output Tables... 81 Clarius Scanner C3 HD: B-Mode ... 81 Clarius Scanner C3 HD: Color Doppler Mode ... 82 Clarius Scanner C3 HD: M-Mode ... 83 Clarius Scanner C3 HD: PW Doppler Mode ... 84 Clarius Scanner C7 HD: B-Mode ... 85 Clarius Scanner C7 HD: Color Doppler Mode ... 86 Clarius Scanner C7 HD: M-Mode ... 87 Clarius Scanner C7 HD: PW Doppler Mode ... 88 Clarius Scanner EC7 HD: B-Mode ... 89 Clarius Scanner EC7 HD: Color Doppler Mode ... 90
revision 5.0
iii
Clarius Ultrasound Scanner - HD Scanners
Clarius Scanner EC7 HD: M-Mode ... 91 Clarius Scanner EC7 HD: PW Doppler Mode ... 92 Clarius Scanner L7 HD: B-Mode ... 93 Clarius Scanner L7 HD: Color Doppler Mode ... 94 Clarius Scanner L7 HD: M-Mode ... 95 Clarius Scanner L7 HD: Needle Enhance B-Mode ... 96 Clarius Scanner L7 HD: Ocular (Ophthalmic) B-Mode ... 97 Clarius Scanner L7 HD: PW Doppler Mode ... 98 Clarius Scanner L15 HD: B-Mode ... 99 Clarius Scanner L15 HD: Color Doppler Mode ... 100 Clarius Scanner L15 HD: M-Mode ... 101 Clarius Scanner L15 HD: Needle Enhance B-Mode ... 102 Clarius Scanner L15 HD: PW Doppler Mode ... 103 Clarius Scanner L20 HD: B-Mode ... 104 Clarius Scanner L20 HD: Color Doppler Mode ... 105 Clarius Scanner L20 HD: PW Doppler Mode ... 106 Clarius Scanner PA HD: B-Mode ... 107 Clarius Scanner PA HD: Color Doppler Mode ... 108 Clarius Scanner PA HD: M-Mode ... 109 Clarius Scanner PA HD: PW Doppler Mode ... 110 Clarius Scanner PA HD: Transcranial Color Doppler Mode ... 111 Clarius Scanner PA HD: Transcranial PW Doppler Mode ... 112
Revision History ... 113
revision 5.0
iv
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 manual provides instructions for use on the Clarius Ultrasound Scanner - HD Scanners family of ultrasound scanners. For models that are not HD, please refer to the appropriate user manual at https://support.clarius.com/hc/en-us/articles/360020188352. 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 HD. • 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 standard and regulatory requirements. • 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.
1
Clarius Ultrasound Scanner - HD Scanners
Target Audience This document is written for trained medical professionals who operate and maintain your Clarius Ultrasound Scanner. It contains instructions and reference material pertaining to the usage and maintenance of the product.
Document Conventions Icons 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
revision 5.0
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.
2
Clarius Ultrasound Scanner - HD Scanners
STANDARD: ISO 7000 - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS 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.
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 HD, accessories, and packaging: OTHER STANDARDS - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS Symbol
revision 5.0
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.
3
Clarius Ultrasound Scanner - HD Scanners
OTHER STANDARDS - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS 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.
You may see these other symbols on your Clarius Scanner HD, 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
revision 5.0
ANATEL
Conforms to the Brazilian Agency of Telecommunications.
n/a
Do not stack boxes.
4
Clarius Ultrasound Scanner - HD Scanners
OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT
revision 5.0
n/a
Do not use knife to open.
n/a
Recycle Li-ion battery in accordance with local, state, and federal regulation
Medical Device
European Medical Device Regulation 2017/745
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 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
6
Clarius Ultrasound Scanner - HD Scanners
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 (<-20°C / -4°F). • Unqualified/untrained personnel purchasing and using the Clarius Scanner HD 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 HD houses a battery and internal power supplies, multichannel beamformer, prescan converter and Wi-Fi components. The battery is removable and comes with a separate charger. The system is a transportable ultrasound system intended for use in emergency medical service (EMS) environments where healthcare is provided by trained healthcare professionals. The EC7 HD and the Clarius 2-in-1 Charging Station HD should be used in a stationary setting.
revision 5.0
7
Clarius Ultrasound Scanner - HD Scanners
Device Description
Battery manufacturer
Clarius
Battery chemistry
Li-ion
Battery management
JEITA guideline compatible charger, in-pack fuel gauge with protection circuitry, and temperature monitoring
Clarius Battery HD
400 discharge cycles before reduction in charge
Clarius Battery Charger HD
Input: 100-240 VAC, 50/60 Hz, 0.45 A Output: 5 VDC, 3.2 A
Clarius Scanner HD
3.6 V/3500 mAh
revision 5.0
8
Clarius Ultrasound Scanner - HD Scanners
Product Dimension
Product Dimension Item
Length (in/mm)
Width (in/mm)
Thickness (in/mm)
Weight (oz/g)
Clarius Scanner C3 HD (CIDN 99-13-00002)
6.5/164
3.1/78
1.5/38
11.4/324
Clarius Scanner C7 HD (CIDN 99-13-00003)
6.7/169
3.1/78
1.5/38
10.5/298
Clarius Scanner EC7 HD (CIDN 99-13-00006)
12.9/328
3.1/78
1.5/38
12.1/342
Clarius Scanner L7 HD (CIDN 99-13-00004)
6.5/165
3.1/78
1.5/38
10.4/296
Clarius Scanner L15 HD (CIDN 99-13-00005)
6.5/165
3.1/78
1.5/38
10.7/304
Clarius Scanner L20 HD (CIDN 99-13-00014)
6.5/165
3.1/78
1.5/38
10.7/304
Clarius Scanner PA HD (CIDN 99-13-00007)
6.5/166
3.1/78
1.5/38
10.6/300
Clarius Battery HD (CIDN 99-13-00010)
1.1/27
2.87/72
1.3/32
2.4/68
Clarius Battery Charger HD (CIDN 99-13-00008)
1.9/48
2.9/74
1.9/49
2.1/60
Product Usage Indications for Use The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic1 , fetal, abdominal, intraoperative (non-neurological, non-central nervous system, non-central cardiovascular system), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
1. Only applicable to the L7 HD scanner.
revision 5.0
9
Clarius Ultrasound Scanner - HD Scanners
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.
revision 5.0
10
Clarius Ultrasound Scanner - HD Scanners
Product Usage
Clarius Scanner C3 HD
DEVICE NAME: CLARIUS SCANNER C3 HD 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.
revision 5.0
11
Clarius Ultrasound Scanner - HD Scanners
Product Usage
Clarius Scanner C7 HD
DEVICE NAME: CLARIUS SCANNER C7 HD 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.
revision 5.0
12
Clarius Ultrasound Scanner - HD Scanners
Product Usage
Clarius Scanner EC7 HD
DEVICE NAME:CLARIUS SCANNER EC7 HD 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.
revision 5.0
13
Clarius Ultrasound Scanner - HD Scanners
Product Usage
Clarius Scanner L7 HD
DEVICE NAME: CLARIUS SCANNER L7 HD 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; B+PWD Note 1
Small Organ (Thyroid, Prostate, Scrotum, Breast)
P
P
P
P
B+CD; B+PD; B+PWD
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 Note 1
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.
revision 5.0
14
Clarius Ultrasound Scanner - HD Scanners
Product Usage
Clarius Scanner L15 HD
DEVICE NAME: CLARIUS SCANNER L15 HD 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
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; B+PWD Note 1
Small Organ (Thyroid, Prostate, Scrotum, Breast)
P
P
P
P
B+CD; B+PD; B+PWD
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 Note 1
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.
revision 5.0
15