P005794-004A KOSMOS User Guide, ... Turning on Kosmos Bridge and Kosmos Torso To turn on Kosmos Bridge

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  • User Guide

  • P005794-004, Rev A

    July 2020

    *Property of Cypress.

    © EchoNous, Inc., 2020

  • KOSMOS User Guide i

    CHAPTER 1 Getting Started 1 What’s new in this release? 1 Package contents 2 Intended users 2 Intended use/indications for use 3

    Contraindications 3

    General warnings and cautions 4 User guide 5

    Symbols in this user guide 6 User guide conventions 6

    EchoNous customer support 7

    CHAPTER 2 KOSMOS Overview 9 What is KOSMOS? 9 KOSMOS clinical applications 9 Training 10 KOSMOS classifications 10 Patient environment 11 KOSMOS capabilities 11

    Overview 11 Using ultrasound, ECG, and DA signals simultaneously 11 Using AI-assisted EF workflow to calculate ejection fraction 11

    CHAPTER 3 Using KOSMOS 13 Kosmos hardware 13

    Kosmos Bridge 13 Kosmos TorsoKosmos power supply 15 Kosmos Bridge stand 15 Kosmos ECG patient cable 16 Kosmos binaural headset 16

    Connecting Kosmos Torso 17 Connecting the Kosmos power supply 18 Setting up the Kosmos Bridge stand 18

  • ii KOSMOS User Guide

    Turning Kosmos Bridge on and off 19 Turning on Kosmos Bridge and Kosmos Torso 19 Turning off Kosmos Bridge 19

    Using the Kosmos Bridge handle controls 20 Turning on the handle controls 21 Ergonomic considerations while using the handle controls 22

    General interaction 24 Home screen 24 Imaging screen: Ultrasound tab (B-mode) 25 Imaging screen: ECG/DA tab 25 Ultrasound controls 26 On-screen keyboard 26

    Understanding the different waveforms 27 ECG 27 DA 28

    Configuring KOSMOS settings 29 Setting imaging preferences 29 Configuring ECG and DA signals 30 Setting the language, date, and time 30 To turn off the automatic date and time (provided by your

    network), tap to the left of the Automatic date and time button to turn it off. 31

    Configuring the handle controls 31 Adjusting the volume 31 Setting brightness 31

    Configuring administrator preferences 31 Managing security settings 32 Managing PACS archives 33 Installing software updates 36 Managing network and internet settings 36 Setting the sleep mode interval 37 Changing privacy settings 37 Viewing information about KOSMOS 38 Registering KOSMOS 38 Resetting KOSMOS to the factory settings 38

    Wireless networking 39 Functions 39 Connection specifications 39

  • KOSMOS User Guide iii

    CHAPTER 4 Incorporating ECG and DA Signals 41 Overview 41

    ECG 41 DA 42

    Benefits of using ECG and DA signals with ultrasound 42 Using the Kosmos ECG patient cable 43 Attaching the Kosmos binaural headset 45 Viewing the ECG and DA signals 46

    Signal scrolling 46 ECG signal indicator 47

    Preserving the ECG and DA signals when freezing an image or taking a clip 47

    Archiving and exporting ECG and DA waveforms 47

    CHAPTER 5 Performing an Exam 49 Overview 49 Exam workflows 50

    Standard workflow 50 Quick workflow 51 AI-assisted EF workflow 52

    Managing exams 53 Starting an exam 53 Searching for an exam 53 Deleting exams 53 Completing exams 54

    Managing patient data 54 Adding a new patient 54 Searching for a patient 54 Changing to another patient 55 Editing a patient record 55 Merging two patient records 55 Deleting patient records 56

    Imaging modes 57 B-mode 57 M-mode 57 Color-mode 58

  • iv KOSMOS User Guide

    Image mode controls 60

    Using the KOSMOS AI-assisted EF workflow 62 Calculating EF with the AI-assisted EF workflow 62 Reviewing/adjusting the ED/ES frames and LV contours 64 Recommendations for acquiring optimal A4C and A2C clips for

    accurate EF calculations 67 Error conditions and system notifications for KOSMOS AI-assisted

    EF workflow 68

    Acquiring images and clips 68 Completing an exam 69

    CHAPTER 6 Reviewing an Exam 71 Starting an exam review 71 Annotating images and clips 72

    Navigating to the Edit Image screen 72 Annotation tools 73 Auto-labeling tool 73 Measuring with the caliper tool 76 Deleting annotations 77

    Managing images and clips 78 Filtering images and clips 78 Selecting images and clips 79 Trimming and saving images and clips 79 Deleting images and clips 80

    Reviewing and editing a report 80 Opening a report 80 Editing a report 80

    Exporting images and clips to a USB drive 82 Completing an exam review 83 Archiving an exam to a PACS server 84 Deleting an exam 85

    CHAPTER 7 Kosmos Torso 87 Kosmos Torso sheaths 87 Ultrasound transmission gels 88

  • KOSMOS User Guide v

    Kosmos Torso storage 88 Daily storage 88 Storage for transport 88

    CHAPTER 8 Safety 89 Electrical safety 89

    References 89

    Labeling symbols 90 Contact information 97

    Biological safety 98 ALARA education program 98 Acoustic output tables 101 Measurement accuracy 108 Control effects 109 Related references 110 Transducer surface temperature rise 110 ECG supplemental information 110

    Ergonomics 112 Electromagnetic compatibility 113

    Electromagnetic emissions 114 Electromagnetic immunity 115 Separation distances 119 Certificate and compliance 119 Intentional radiator 120 Class B device 120 Industry Canadian statement 121

    Standards 121 HIPAA 121 DICOM 122

    CHAPTER 9 KOSMOS Maintenance 123 Cleaning and disinfecting 123

    General cautions 123 Kosmos Bridge 124 Kosmos Torso 125 Kosmos ECG patient cable 130

  • vi KOSMOS User Guide

    Kosmos binaural headset 133

    Recycling and disposal 133 Troubleshooting 134

    Preventive inspection, maintenance, and calibration 134 Kosmos Bridge handle controls 134

    CHAPTER 10 Specifications 137 System specifications 137

    Kosmos Torso dimensions 137 Kosmos Bridge dimensions 137 Kosmos binaural headset 137 Kosmos ECG patient cable 138 Kosmos power supply 138

    Environmental operating and storage conditions 138 Operating, charging, transport, and storage condition

    ranges 139 Mode of operation 139 Power supply (charger) 139 Internal batteries 140

    CHAPTER 11 IT Network 141 Wireless networking 141

    Functions 141 Connection specifications 141

    Network for connecting the device 141 Specifications for the connection 142

    Hardware specification 142 Software specifications 142 Security 142

    IT network failure recovery measures 143

  • KOSMOS User Guide vii

    CHAPTER 12 Glossary 145

    APPENDIX A Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency 2020 151 Enforcement Policy for Imaging Systems During the

    Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 151

    Indications 151 Product’s performance 152 Potential risks and mitigations 153 General warnings and cautions 155 Cleaning and disinfection 155 Summary of the dataset characteristics used in the development

    of the auto-labeling tool 155

  • KOSMOS User Guide 1

    CHAPTER 1 Getting Started

    What’s new in this release?

    New features and changes for the 1.0.58 version of KOSMOS® include:

    • Auto-labeling tool. When you are scanning the heart (including the AI- assisted EF workflow), there is now an auto labeling tool that helps you identify parts of the heart. The labels that appear while scanning are only there while you are scanning; after you save the image or clip, the labels will not be there.

    • Handle controls for Kosmos Bridge. Turning on the new handle control feature with Cypress CapSense* technology lets you freeze/unfreeze, adjust gain, and save an image/store a clip by tapping/sliding the appropriate button on the handle.

    • To improve workflow and reduce the number of clicks, you can now add a new patient and start an exam from the Patient screen.

    • Less clicks when using the AI-assisted EF workflow. Once you have a good A4C image of the heart and tap A4C for KOSMOS to calculate EF, the system now automatically accepts the image after four seconds; the same is true for A2C.

    KOSMOS is an FDA-cleared medical device; however, the new auto- labeling tool is not yet cleared by the FDA. Instead, EchoNous® is following the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 for this new feature. There are important warnings and cautions in addition to different intended users and indications for use.

    For detailed information, refer to Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020.

  • Getting Started

    2 KOSMOS User Guide

    • M-mode caliper. You can now place a second measurement caliper on an image/clip.

    Package contents

    The KOSMOS box contains the following items:

    • KOSMOS system, comprised of the Kosmos Bridge and Kosmos Torso • Kosmos power supply • Kosmos ECG patient cable • Kosmos binaural headset • Bridge stand • KOSMOS Quick Start Guide • KOSMOS UI Quick Guide • USB flash drive containing:  KOSMOS User Guide  KOSMOS Quick Start Guide  KOSMOS UI Quick Guide  ALARA education program (ISBN 1-932962-30-1, Medical Ultrasound

    Safety)  Terms and conditions of warranty  Manufacturer Disclosure Statement for Medical Device Security (MDS2)  DICOM Conformance Statement

    Intended users

    KOSMOS is intended to be used by qualified