EchoNous KOSMOS User manual

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KOSMOS User Guide i
CHAPTER 1 Getting Started 1
Package contents 1
Intended users 2
Intended use/indications for use 2
Contraindications 3
General warnings and cautions 3
Symbols in this user guide 5
User guide conventions 5
Customer support 6
CHAPTER 2 KOSMOS Overview 7
What is KOSMOS? 7
KOSMOS clinical applications 7
Training 8
KOSMOS classifications 8
Patient environment 9
KOSMOS capabilities 9
Overview 9
Using ultrasound, ECG, and DA signals simultaneously 9
CHAPTER 3 Using KOSMOS 11
Kosmos hardware 11
Kosmos Bridge 11
Kosmos Torso 12
KOSMOS power supply 13
KOSMOS Bridge stand 13
Kosmos ECG patient cable 13
Binaural headset 14
Connecting Kosmos Torso 14
Connecting the power supply 15
Setting up the Kosmos Bridge stand 16
Turning Kosmos Bridge on and off 16
Turning on Kosmos Bridge and Kosmos Torso 16

ii KOSMOS User Guide
Turning off Kosmos Bridge 17
General interaction 18
Home screen 18
Imaging screen: Ultrasound tab (B-mode) 19
Imaging screen: Three-signal tab 19
Ultrasound controls 20
On-screen keyboard 20
Understanding the different waveforms 21
ECG 21
DA 22
Configuring KOSMOS settings 23
Setting imaging preferences 23
Configuring ECG and DA signals 24
Setting the language, date, and time 24
Adjusting the volume 25
Setting brightness 25
Configuring administrator preferences 25
Managing security settings 25
Managing PACS archives 27
Installing software updates 29
Managing network and internet settings 30
Setting the sleep mode interval 30
Changing privacy settings 30
Viewing information about KOSMOS 31
Registering KOSMOS 31
Resetting KOSMOS to the factory settings 31
Wireless networking 32
Functions 32
Connection specifications 32
CHAPTER 4 Incorporating ECG and DA Signals 35
Overview 35
ECG 35
DA 36
Benefits of using ECG and DA signals with ultrasound 36
Using the Kosmos ECG patient cable 37
Attaching the Kosmos binaural headset 39

KOSMOS User Guide iii
Viewing the ECG and DA signals 40
Signal scrolling 40
ECG signal indicator 41
Preserving the ECG and DA signals when freezing an image
or taking a clip 41
Archiving and exporting ECG and DA waveforms 41
CHAPTER 5 Performing an Exam 43
Overview 43
Exam workflows 44
Recommended workflow 44
Quick workflow 45
Managing exams 46
Starting an exam 46
Searching for an exam 46
Deleting exams 46
Completing exams 47
Managing patient data 47
Adding a new patient 47
Searching for a patient 47
Changing to another patient 48
Editing a patient record 48
Merging two patient records 48
Deleting patient records 49
Imaging modes 50
B-mode 50
M-mode 50
Color-mode 52
Image mode controls 54
Acquiring images and clips 55
Completing an exam 55
CHAPTER 6 Reviewing an Exam 57
Starting an exam review 57
Annotating images and clips 57

iv KOSMOS User Guide
Navigating to the Edit Image screen 58
Annotation tools 59
Measuring with the caliper tool 59
Deleting annotations 60
Managing images and clips 61
Filtering images and clips 61
Selecting images and clips 62
Trimming and saving images and clips 62
Deleting images and clips 62
Reviewing and editing a report 63
Opening a report 63
Editing a report 63
Exporting images and clips to a USB drive 64
Completing an exam review 65
Archiving an exam to a PACS server 65
Deleting an exam 66
CHAPTER 7 Kosmos Torso 69
Kosmos Torso sheaths 69
Ultrasound transmission gels 70
Kosmos Torso storage 70
Daily storage 70
Storage for transport 70
CHAPTER 8 KOSMOS Maintenance 71
Cleaning and disinfecting 71
General cautions 71
Kosmos Bridge 72
Kosmos Torso 73
Kosmos ECG patient cable 77
Binaural Headset 79
Recycling and disposal 80
Troubleshooting 80
Preventive inspection, maintenance, and calibration 80

KOSMOS User Guide v
CHAPTER 9 Safety 83
Electrical safety 83
References 83
Labeling symbols 84
Contact information 89
Biological safety 90
ALARA education program 90
Acoustic output tables 92
Measurement accuracy 99
Control effects 99
Related references 99
Transducer surface temperature rise 100
ECG supplemental information 100
Ergonomics 101
Electromagnetic compatibility 102
Electromagnetic emissions 103
Electromagnetic immunity 104
Separation distances 107
Intentional radiator 107
Class B device 108
Industry Canadian statement 108
Standards 109
HIPAA 109
DICOM 109
CHAPTER 10 Specifications 111
System specifications 111
Kosmos Torso dimensions 111
Kosmos Bridge dimensions 111
Binaural headset 111
ECG cable 112
Power supply 112
Environmental operating and storage conditions 112
Operating, charging, transport, and storage condition
ranges 113
Mode of operation 113
Power supply (charger) 113

vi KOSMOS User Guide
Internal batteries 114
CHAPTER 11 IT Network 115
Wireless networking 115
Functions 115
Connection specifications 115
Network for connecting the device 115
Specifications for the connection 116
Hardware specification 116
Software specifications 116
Security 116
IT network failure recovery measures 117
CHAPTER 12 Glossary 119

KOSMOS User Guide 1
CHAPTER 1 Getting Started
This user guide is intended to assist you with the safe and effective operation of
KOSMOS. Before attempting to operate KOSMOS, read this user guide and
strictly observe all the included warnings and cautions. Also, pay special
attention to the information in the chapter called Safety.
This user guide and any digital media (and the information they contain) is the
proprietary and confidential information of EchoNous and may not be
reproduced, copied in whole or in part, adapted, modified, disclosed to others,
or disseminated without the prior written permission of the EchoNous legal
department. This document or digital media is intended to be used by
customers and is licensed to them as part of their EchoNous purchase. Use of this
document or digital media by unauthorized persons is strictly prohibited. This
user guide is also available through the EchoNous website, or a paper copy may
be supplied on request.
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:
Federal (United States) law restricts this device to sale by or on the
order of a physician.

Getting Started
2KOSMOS User Guide
 KOSMOS User Guide
 KOSMOS Quick Start Guide
 KOSMOS UI Quick Guide
 ALARA education program (ISBN 1-932962-30-1, Medical Ultrasound
Safety)
 “How To” and clinical videos
 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 and trained healthcare
professionals that are legally authorized by law in the country, state, or other
local municipality in which they practice to use the device. The list of the
potential users includes but is not limited to (based on title/geographical
location): Medical specialists, primary care physicians, point-of-care users,
sonographers, medical healthcare technicians, nurses, nurse practitioners,
physician assistants, and medical students.
Users may or may not be working under supervision or authority of a physician.
Intended use/indications for use
KOSMOS is intended to be used by qualified and trained healthcare
professionals in the clinical assessment of the cardiac and pulmonary systems
and the abdomen by acquiring, processing, displaying, measuring, and storing
synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital
auscultation (DA) sounds and waveforms.
With respect to its ultrasound imaging capabilities, KOSMOS is a general purpose
diagnostic ultrasound system used in the following clinical applications and
modes of operation:
To help ensure the diagnostic quality of the images obtained, all patient
images must be obtained by qualified and trained healthcare
professionals.

KOSMOS User Guide 3
General warnings and cautions
•Clinical applications: Cardiac, Thoracic/Lung, Abdominal, Peripheral Vascular,
and Image Guidance for Needle/Catheter Placement
•Modes of operation: B-mode, M-mode, Color Doppler, combined modes of
B+M and B+CD, and Harmonic Imaging
KOSMOS is intended to be used in clinical care and medical education settings
on adult and pediatric patient populations.
The device is non-invasive, reusable, and intended to be used on one patient at a
time.
Contraindications
KOSMOS is designed for transcutaneous scanning and transthoracic
echocardiography only.
KOSMOS is not intended for ophthalmic use or any use causing the acoustic
beam to pass through the eye.
General warnings and cautions
Show care when scanning near a wound to avoid damaging or
further injuring the affected area.
Federal (USA) law restricts this device to sale by or on the order
of a physician.
KOSMOS is not MRI compatible and should not be used in an MRI suite.
KOSMOS is not for use in oxygen-rich environments.
To avoid the risk of electrical shock, do not allow any part of KOSMOS
(except for the Kosmos Torso lens and the Kosmos ECG patient cable) to
touch the patient.

Getting Started
4KOSMOS User Guide
To avoid the risk of electrical shock or injury, do not open the Kosmos
Bridge or Kosmos Torso enclosures for any reason. All internal
adjustments and replacements (such as the battery) need to be made by
a qualified KOSMOS technician.
To avoid the risk of electrical shock and fire hazard, inspect the power
supply, AC power cords, cables, and plugs on a regular basis to ensure
that they are not damaged.
The KOSMOS system, including the Kosmos ECG patient cable, is not
defibrillation proof. To prevent injury to the operator/bystander, Kosmos
Torso and the Kosmos ECG patient cable/leadwires must be removed
from patient contact before the application of a high-voltage
defibrillation pulse.
Before using KOSMOS for needle guidance procedures, you must have
training in the applicable interventional procedures in addition to
training in the use of ultrasound imaging for needle guidance. Well
known limitations of ultrasound physics may lead to an inability to
visualize the needle or differentiate the needle from acoustic artifacts.
During fluid removal procedures of the pericardium, pleural cavity and
abdomen, the potential exists for serious complications including,
without limitation, the following: pneumothorax, arterial puncture,
cardiac puncture, or damage to other organs.
As a precaution, be careful when scanning near a wound or over a
dressing.
Do not use KOSMOS for intracavity imaging.
Federal law restricts this device to sale by or on the order of a physician.
KOSMOS uses Bluetooth wireless communication technology.
Keep power cords away from trafficked areas.

KOSMOS User Guide 5
Symbols in this user guide
Symbols in this user guide
User guide conventions
The following style conventions are used in this guide:
•Numbered and lettered steps must be performed in a specific order.
•Bulleted items are lists in no specific order.
•KOSMOS touch screen icons and buttons are indicated in bold, such as SCAN.
•The word:
 Tap refers to touching the screen quickly with your finger
 Drag refers to touching the screen with your finger and then moving your
finger across the screen
 Swipe refers to moving your finger across the screen quickly
 Pinch refers to moving two fingers in a pinch motion or pinch release
motion across the screen
 Check refers to tapping a check box to enable the associated function
 Clear refers to tapping a check box to disable the associated function
 Select refers to tapping a menu item from a menu list
•Links to other sections within the guide appear bold and colored, such as the
cross reference, see Imaging modes.
Warning A warning describes precautions to prevent injury or loss of life.
Caution A caution describes precautions to prevent damage to the
device.
Note A note provides supplemental information.

Getting Started
6KOSMOS User Guide
Customer support
In addition to this user guide, you can find clinical videos, how-to videos, and on-
board help in Kosmos Bridge.
You can also contact customer support:
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Web: www.echonous.com

KOSMOS User Guide 7
CHAPTER 2 KOSMOS Overview
What is KOSMOS?
KOSMOS consists of Kosmos Bridge, which runs the EchoNous system software,
and is connected by cable to Kosmos Torso. KOSMOS provides portable
ultrasound imaging and supports the following:
•Noninvasive heart, lungs, and abdominal ultrasound imaging
•Three lead, single-channel ECG
•Digital auscultation (DA) signals
KOSMOS uses pulse-echo ultrasound to generate real-time ultrasound
images. This process involves transmitting high-frequency acoustic pulses
into the body with Kosmos Torso, detecting the returned signals with
Kosmos Torso and processing the return echoes through analog and digital
processing to form real-time images of anatomy (B-mode and M-mode)
and blood flow (Color Doppler).
Kosmos Bridge is a custom-designed tablet approved, preconfigured, and
supplied by EchoNous. Kosmos Bridge is provided with a power supply. When
the display is connected to Kosmos Torso, the combination is configured as a
medical electrical system.
KOSMOS provides optional wireless connectivity, allowing remote storage. Both
the Kosmos Bridge and the Kosmos Torso are battery powered.
KOSMOS clinical applications
KOSMOS is for non-invasive imaging of the human body and is intended for the
following applications:
•Cardiac
•Lung

KOSMOS Overview
8KOSMOS User Guide
•Abdominal
Training
KOSMOS is intended to be used by clinicians with appropriate professional
qualifications and clinical training.
All users should read the generic ALARA education program supplied with
KOSMOS (see ISBN 1-932962-30-1, Medical Ultrasound Safety on the USB flash
drive) or the Health Canada Guidelines for the Safe Use of Diagnostic Ultrasound
available on the Health Canada website. This program outlines the guiding
principle for diagnostic ultrasound, where the qualified user keeps ultrasound
exposure to “as low as reasonably achievable” while performing a diagnostic
examination.
In addition to the above, users intending to use the ultrasound imaging function
must have appropriate training in ultrasound. Appropriate information on
training may be obtained by contacting EchoNous or your local professional
body.
KOSMOS classifications
•KOSMOS has an internal battery which allows operation when AC power is
not available.
•The Kosmos power supply classification for protection against electric shock:
Class II equipment.
•Kosmos Torso is a Type BF Applied Part. The Applied Parts include:
 The lens (front surface) of Kosmos Torso
 ECG electrodes, as connected to the Kosmos ECG patient cable
•Kosmos Bridge is IP22
•Kosmos Torso is IPx7
•ECG is type BF

KOSMOS User Guide 9
Patient environment
Patient environment
KOSMOS is intended to be used in a medical facility. It is battery powered and is
expected to be used in the patient environment. Scanning can also be
performed when KOSMOS is plugged into the EchoNous-approved power
supply. It is important to only use the EchoNous-approved power supply; if you
use another power supply, scanning will be disabled (but KOSMOS will continue
to charge).
KOSMOS capabilities
Overview
KOSMOS uses ultrasound imaging to permit a clinical assessment of the key
cardiac structures, including the heart chambers, heart valves, and major heart
vessels for adult and pediatric patients. As part of this clinical assessment,
KOSMOS permits visualization of blood flow using color Doppler technology.
Using ultrasound, ECG, and DA signals simultaneously
In most situations, ultrasound, auscultation, and ECG are a few of the most
valuable signals used in medicine for assessing the heart. KOSMOS seamlessly
integrates these three signals to acquire, visualize, and analyze the results with a
single device.
To properly capture and analyze the dynamic anatomic and physiological
information associated with the signals, KOSMOS acquires, stores, and displays
these signals in synchronization. As a user, you can add DA, ECG, or both signals
to the ultrasound exam.

KOSMOS User Guide 10
KOSMOS capabilities
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KOSMOS User Guide 11
CHAPTER 3 Using KOSMOS
Kosmos hardware
The following drawings point out the buttons and controls on Kosmos Bridge
and Kosmos Torso.
Kosmos Bridge
Use only accessories recommended by EchnoNous. Do not connect any
USB accessories to Kosmos Bridge that are not recommended by
EchoNous; doing so may cause electric shock and/or compromise the
security of the device. Contact EchoNous or your local representative for
a list of accessories available from or recommended by EchoNous.
Microphone Power button
Volume controls
Camera
USB drive

Using KOSMOS
12 KOSMOS User Guide
Kosmos Torso
Side
Camera
Handle
Volume controls
USB port
Orange orientation marker
Kosmos Torso cable