EchoNous KOSMOS User Manual
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EchoNous KOSMOS User Manual

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Summary of Contents for EchoNous KOSMOS

  • Page 2 This page left intentionally blank...

  • Page 3: Table Of Contents

    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 KOSMOS User Guide...
  • Page 4 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 Incorporating ECG and DA Signals 35...
  • Page 5 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 Reviewing an Exam 57 CHAPTER 6 Starting an exam review 57 Annotating images and clips 57 KOSMOS User Guide...
  • Page 6 KOSMOS Maintenance 71 CHAPTER 8 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...
  • Page 7 Standards 109 HIPAA 109 DICOM 109 Specifications 111 CHAPTER 10 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...
  • Page 8 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 Glossary 119 CHAPTER 12 KOSMOS User Guide...

  • Page 9: Getting Started

    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.

  • Page 10: Intended Users

    (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:...

  • Page 11: Contraindications

    General warnings and cautions 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.
  • Page 12 Getting Started 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.

  • Page 13: Symbols In This User 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 ...

  • Page 14: Customer Support

    Getting Started 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: 844-854-0800 Fax: 425-242-5553 Email: info@echonous.com Web: www.echonous.com KOSMOS User Guide...

  • Page 15: Kosmos Overview

    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 •...

  • Page 16: Training

    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.

  • Page 17: Patient Environment

    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.
  • Page 18 KOSMOS capabilities This page left intentionally blank KOSMOS User Guide...

  • Page 19: Using Kosmos

    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. The following drawings point out the buttons and controls on Kosmos Bridge and Kosmos Torso. Kosmos Bridge...

  • Page 20: Kosmos Torso

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

  • Page 21: Kosmos Power Supply

    Kosmos hardware KOSMOS power supply KOSMOS Bridge stand Kosmos ECG patient cable Clips (attachment point for the ECG electrodes) Connector Yoke Trunk cable Leadwires KOSMOS User Guide...

  • Page 22: Binaural Headset

    Use only accessories recommended by EchnoNous. Do not connect Kosmos Torso into any device other than Kosmos Bridge. Do not attempt to plug Kosmos Torso into the side USB port. To connect Kosmos Torso to Kosmos Bridge: Plug the Kosmos Torso connector into the slot below the Kosmos Bridge ...

  • Page 23: Connecting The Power Supply

    Bridge using the power supply provided with the device. Avoid excessive bending or twisting of the mains power cord. Only use KOSMOS with power supplies provided by EchoNous. If you try to use a power supply not approved by EchoNous, Kosmos Bridge will continue to charge properly but will disable scanning.

  • Page 24: Setting Up The Kosmos Bridge Stand

    Place Kosmos Bridge on it. Adjust the angle to the best viewing position. Tighten the screws. Turning Kosmos Bridge on and off Turning on Kosmos Bridge and Kosmos Torso To turn on Kosmos Bridge and Kosmos Torso: Press the Power button. KOSMOS User Guide...

  • Page 25: Turning Off Kosmos Bridge

    Turning off Kosmos Bridge To turn off Kosmos Bridge: Press the Power button. Do one of the following: • When prompted, tap OK. • Wait the few seconds for KOSMOS to turn itself off. KOSMOS User Guide...

  • Page 26: General Interaction

    Using KOSMOS General interaction Home screen Lung scan Heart scan Abdominal scan Patient list User guides and clinical/ Exam list Settings screen how-to videos KOSMOS User Guide...

  • Page 27: Imaging Screen: Ultrasound Tab (B-Mode)

    Imaging screen: Ultrasound tab (B-mode) Depth Gain Color-mode M-mode Imaging screen: Three-signal tab Patient Patient ID Organization Date Exam Battery remaining Ultrasound Storage remaining Sweep Speed ECG gain DA gain Freeze Review Save image Save clip Scan area KOSMOS User Guide...

  • Page 28: Ultrasound Controls

    Gain Color-mode M-mode Near gain and far gain On-screen keyboard When filling out patient forms or configuring settings in KOSMOS, you can type text by tapping the text field you want to edit. An on-screen keyboard appears. KOSMOS User Guide...

  • Page 29: Understanding The Different Waveforms

    ECG (shared between ECG and DA). waveform by increasing and A lower sweep speed displays decreasing the ECG gain. more waveforms, while a higher sweep speed displays fewer waveforms but provides greater details of individual waveforms. KOSMOS User Guide...
  • Page 30 DA waveform visualization of the DA by increasing and decreasing waveform. You can adjust the the DA gain. volume of the audio (and mute the audio) with the physical buttons on Kosmos Bridge. KOSMOS User Guide...

  • Page 31: Configuring Kosmos Settings

    — • Patient ID Displays the patient ID in the top bar of the imaging screen. To configure the way KOSMOS records clips, tap one of the following options under Record clip: — • Retrospective Captures frames from the cine buffer when you tap the Clip icon.

  • Page 32: Configuring Ecg And Da Signals

    Turning on the automatic date and time will not automatically select time zone. You have to manually adjust the time zone. To set the language, date, and time for KOSMOS: From the Home screen, tap SETTINGS. Tap Language, Date, and Time.

  • Page 33: Adjusting The Volume

    (but you won’t be able to save the exam). If KOSMOS is only used by one person, then you may not want to set up a PIN. However, if the device is going to be used by more than one person, we recommend setting up both administrator and clinical user PINs.
  • Page 34 Using KOSMOS user PIN provides access to all of the KOSMOS screens, with the exception of the administration settings screens. It’s very important to keep track of the PINs you create and store them in a safe place. If you forget your PIN, you must contact EchoNous Customer Support, and they will send you a one-use USB stick so you can change your PIN.

  • Page 35: Managing Pacs Archives

    However, all the jobs in the existing queue and any scheduled archives must first be completed. Type the following information in the DICOM connection area: — • KOSMOS AE title KOSMOS’ Application Entity title — • PACS AE title Archive server’s Application Entity title...
  • Page 36 Using KOSMOS • PING to test the network connection between KOSMOS and the PACS archive • Verify to check the availability of the active PACS archive. Kosmos Bridge displays the results on-screen. In the Profile nickname box, type a unique name to display in the PACS profile list.

  • Page 37: Installing Software Updates

    Installing software updates Before updating the software, back up all patient data. You can manually check for software updates or configure KOSMOS to automatically check to see if there is a new update available. You can also choose to have KOSMOS automatically download and install any updates.

  • Page 38: Managing Network And Internet Settings

    During periods of inactivity, KOSMOS automatically switches to sleep mode to preserve battery life and prevent overheating. If KOSMOS is in sleep mode, briefly press the Power button to wake it up; the display does not indicate activity when KOSMOS is asleep.

  • Page 39: Viewing Information About Kosmos

    Tap Admin. Tap About. Tap REGISTER. Resetting KOSMOS to the factory settings You can restore KOSMOS to its factory settings; however, be aware that this will erase all the data from internal storage. To reset KOSMOS to the factory settings: Network).

  • Page 40: Wireless Networking

    Hardware specification 802.11 a/b/g/n/ac, Bluetooth 4.2 or later Software Specification KOSMOS is connected to PACS by the DICOM standard. For details, refer to the DICOM Conformance Statement that is on the USB flash drive. EU Compliance EchoNous, Inc. hereby declares that this wireless device is in compliance with Directives 2014/53/EU and 93/42/EEC.
  • Page 41 This restriction applies in: AT, BE, BG, CH, CY, CZ, DE, DK, EE, EL, ES, FI, FR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK, TR, UK. KOSMOS User Guide...
  • Page 42 Using KOSMOS This page left intentionally blank KOSMOS User Guide...

  • Page 43: Incorporating Ecg And Da Signals

    ECG lead, which can be any of Lead I, Lead II, or Lead III. The KOSMOS ECG feature is used with the Kosmos ECG patient cable. One end of the Kosmos ECG patient cable connects to Kosmos Torso, and the other end has three RA/LA/LL leadwires.

  • Page 44: Benefits Of Using Ecg And Da Signals With Ultrasound

    Benefits of using ECG and DA signals with ultrasound Ultrasound imaging, ECG, and DA are all integrated into Kosmos Torso in a time- synchronized manner. Being able to view the real-time, synchronized signals of ultrasound, ECG, and DA is a valuable cross reference between different views of the same physiological event.

  • Page 45: Using The Kosmos Ecg Patient Cable

    Using the Kosmos ECG patient cable Using the Kosmos ECG patient cable The Kosmos ECG patient cable connects to Kosmos Torso by means of coupling magnets. Kosmos Torso contains a small permanent magnet where the Kosmos ECG patient cable connects. Do not use KOSMOS on patients with cardiac pacemakers or other electronic implantable devices.
  • Page 46 IEC recommendation: • R: Right arm (red clip) • L: Left arm (yellow clip) • F: Left leg (green clip) Plug the connector end of the Kosmos ECG patient cable into the magnetic slot on Kosmos Torso. KOSMOS User Guide...

  • Page 47: Attaching The Kosmos Binaural Headset

    The DA microphones and signal processing are built into KOSMOS. The Kosmos binaural headset is supplied for auscultation. To attach the Kosmos binaural headset: Plug the USB end of the Kosmos binaural headset into the USB slot on Kosmos Bridge. Put the headset on.

  • Page 48: Viewing The Ecg And Da Signals

    When the scrolling begins, the area to the right of the cursor is blank, while the new scrolling overlaps the old signals from the second round of scrolling. The DA audio is synchronized with the DA waveform scrolling. KOSMOS User Guide...

  • Page 49: Ecg Signal Indicator

    • The patient is not moving • The connection of leadwires to Kosmos Torso is not loose Preserving the ECG and DA signals when freezing an image or taking a clip You can freeze an image or a take a clip with the ECG and DA waveforms so you can review them in the Editing screen.

  • Page 50: Performing An Exam

    To reduce the risk of infection, use sterile sheaths when conducting needle procedures. To avoid a mix-up of patient data, complete the exam before examining a new patient. With KOSMOS, there are three primary workflows; click one of the links to go to that workflow: • Recommended workflow •...

  • Page 51: Exam Workflows

    Add, edit, and delete annotations and notes Things you can do while reviewing: Review exam • Delete images and clips • Add, edit, and delete annotations and notes • Generate report • Archive exam Complete & save exam Optional step Archive/export exam KOSMOS User Guide...

  • Page 52: Quick Workflow

    Things you can do while reviewing: Review exam • Delete images and clips • Add, edit, and delete annotations and notes • Generate report • Archive exam to PACS • Export exam to USB Complete & save exam Optional step Archive exam KOSMOS User Guide...

  • Page 53: Managing Exams

    There are several ways you can start an exam: • To start scanning immediately, from the Home screen, tap a scan type. When you save the exam, KOSMOS automatically generates a temporary ID and saves the images/clips to the temporary ID. •...

  • Page 54: Completing Exams

    From the Home screen, tap PATIENTS. Tap the Search icon. Type the search criteria for the patient you are looking for, such as name, date of birth, or medical record number. Select the patient from the search result list, and tap DONE. KOSMOS User Guide...

  • Page 55: Changing To Another Patient

    You cannot merge temporary patients. In order to merge two patients, make sure the following fields are complete: First name  Last name   Gender  To merge two patient records: From the Home screen, tap PATIENTS. KOSMOS User Guide...

  • Page 56: Deleting Patient Records

    From the Home screen, tap PATIENTS. Tap the More options icon. Tap Delete all patients without exams. To delete selected patient records: From the Home screen, tap PATIENTS. Tap one or more patient names from patient list. Tap the Trash icon. KOSMOS User Guide...

  • Page 57: Imaging Modes

    M-mode is also known as Motion Mode. It provides a trace of the image displayed over time. A single beam of ultrasound is transmitted, and reflected signals are displayed as dots of varying intensities, which create lines across the screen. KOSMOS User Guide...
  • Page 58 To move the M-Line, use your finger to drag the M-Line to the location you  want. Sweep speed You can change the sweep speed to isolate individual motions. To change the M-Mode sweep speed, tap the Sweep speed icon, and  adjust it to your preferences. KOSMOS User Guide...

  • Page 59: Color-Mode

    Color-mode Color-mode is used to visualize the presence, velocity, and direction of blood flow in a wide range of flow states. When using KOSMOS, you can turn color-mode on and off without it interfering with the system’s color acquisition. B-mode...
  • Page 60 Color map When you open the color map, it shows seven color indexes. By default, it’s set to index 5, and the first one is 0. To change the heart color map: KOSMOS User Guide...

  • Page 61: Image Mode Controls

    To flip the image, double-tap the orientation marker.  Adjusting body mass index (BMI) In KOSMOS, BMI is used to adjust the penetration level. BMI is not calculated or supplied from the patient's height or weight entry. There are three levels of adjustment: •...

  • Page 62: Acquiring Images And Clips

    From the Imaging screen, tap the Save clip icon.  Completing an exam From the Imaging screen, tap the Exam review icon. Tap COMPLETE. If you do not tap COMPLETE from the Exam review screen, KOSMOS automatically completes the exam: KOSMOS User Guide...
  • Page 63 Performing an Exam • When you start a new exam • When you archive the in-progress exam • After a few minutes • When you turn off Kosmos Bridge KOSMOS User Guide...

  • Page 64: Reviewing An Exam

    You can add annotations during the exam when the image is frozen or after you have completed the exam. All annotations are saved as overlays on the image or clip. Once you have archived an image or clip, you cannot annotate it. KOSMOS User Guide...

  • Page 65: Navigating To The Edit Image Screen

    Tap the Save image or Save clip icon. Move the image or clip <?> After scanning a patient: Tap the Exam review icon. Tap the image/clip you want to annotate. Tap the Edit icon. From the Home screen: Tap Exam. KOSMOS User Guide...

  • Page 66: Annotation Tools

    If you have multiple calipers, they display in different colors. To resize the caliper, tap and drag one of its endpoints. To move the caliper, tap anywhere on the caliper except the two end points. KOSMOS User Guide...

  • Page 67: Deleting Annotations

    Can freeze while zoomed (and can unzoom and zoom in frozen state). Deleting annotations To delete one annotation, tap the annotation to select it, then tap DELETE.  To delete all the annotations you have made, tap CLEAR ALL.  KOSMOS User Guide...

  • Page 68: Managing Images And Clips

    Filter images and clips. When you select a filter, only the tagged images/clips are visible in the thumbnail list. You can tag images/clips by tapping the star icon under each image/clip in the thumbnail list so the star turns yellow. KOSMOS User Guide...

  • Page 69: Selecting Images And Clips

    Move the right and left end points of the image. Tap SAVE. Deleting images and clips To delete selected images and clips: icon, and tap Select images/clips. Tap the More options Select the images and clips you want to delete. KOSMOS User Guide...

  • Page 70: Reviewing And Editing A Report

    To edit the exam information: Tap the Edit icon. Make any necessary updates to the section. Adding a text note You can add text notes that will display under each scan. To add a text note: KOSMOS User Guide...

  • Page 71: Exporting Images And Clips To A Usb Drive

    Tap a row to select an exam. Tap the bookmark icon under each of the thumbnails you would like to export. (This is an optional step and only useful if you would like to export some but not all images and clips.) KOSMOS User Guide...

  • Page 72: Completing An Exam Review

    To complete an exam: Tap COMPLETE. When prompted, click OK. Archiving an exam to a PACS server After completing an exam, you can archive it to a PACS server. Once an exam is archived, you cannot edit it. KOSMOS User Guide...

  • Page 73: Deleting An Exam

    Deleting an exam To delete an exam from the Exam list: Tap the left icon next to the exam you would like to delete. The icon turns into a check mark Tap the Trash icon. When prompted, tap OK. KOSMOS User Guide...
  • Page 74 Deleting an exam To delete an exam while reviewing it: Tap the More options icon. Tap Delete the exam. When prompted, click OK. KOSMOS User Guide...
  • Page 75 Reviewing an Exam This page left intentionally blank KOSMOS User Guide...

  • Page 76: Kosmos Torso

    After use, remove and discard the single-use sheath, and clean and disinfect Kosmos Torso using an EchoNous-recommended high-level disinfectant. After inserting Kosmos Torso into the sheath, inspect the sheath for holes and tears. KOSMOS User Guide...

  • Page 77: Ultrasound Transmission Gels

    Kosmos Torso should carry an ISO biohazard label. The KOSMOS battery can only be replaced at an EchoNous facility; however, for shipping/storage, the battery is Li-Ion 3.6V, 6.4 Ah. Daily storage KOSMOS is intended to be used and stored in normal ambient conditions inside a medical facility.

  • Page 78: Kosmos Maintenance

    Do not attempt to clean or disinfect Kosmos Bridge, Kosmos Torso, or the Kosmos Torso cable using a method that is not included here or chemical not listed in this guide. Doing so can damage Kosmos Torso and void the warranty.

  • Page 79: Kosmos Bridge

    KOSMOS Maintenance Kosmos Bridge Kosmos Bridge is not sterile when shipped; do not attempt to sterilize it. To avoid electrical shock, before cleaning, turn off Kosmos Bridge and disconnect it from the power supply. Cleaning Avoid spraying the cleaning and disinfection solutions directly onto Kosmos Bridge.

  • Page 80: Kosmos Torso

    Kosmos Torso Cleaning The following cleaning instructions must be followed for Kosmos Torso. Kosmos Torso must be cleaned after each use. Cleaning Kosmos Torso is an essential step before effective disinfection. Before cleaning Kosmos Torso, read the following warnings and cautions.
  • Page 81 Presaturated wipes, and observe the recommended minimum wet contact time. With a new wipe, clean the cable and Kosmos Torso, starting from the exposed cable, wiping toward the Kosmos Torso head to avoid cross- contamination. Observe the required wet contact time. Monitor Kosmos Torso for wet appearance.
  • Page 82 Kosmos Torso and void the warranty. If Kosmos Torso has come into contact with any of the following, use the high-level cleaning and disinfection procedure: Blood, broken skin, mucosal membranes, bodily fluids...
  • Page 83 Do not immerse Kosmos Torso longer than the minimum time needed for semi-critical level of disinfection. Rinse Kosmos Torso for at least one minute in clean water up to the point of immersion to remove chemical residue. Do not soak or immerse any other part of Kosmos Torso, such as the cable, strain relief, or connector.

  • Page 84: Kosmos Ecg Patient Cable

    The cable must be cleaned after each use. Cleaning the cable is an essential step before effective disinfection. Before cleaning the Kosmos ECG patient cable, read the following warnings and cautions. Always disconnect the cable from Kosmos Torso before cleaning and disinfecting.
  • Page 85 Remove the ECG clips from the Enzol solution, and run them under running water for 1 minute. Ensure no gel or any particulate matter is visible after this cleaning step. Before continuing with disinfection, ensure the Kosmos ECG patient cable is visibly dry. Cleaning detergent solution for Kosmos ECG patient cable TABLE 8-3.
  • Page 86 With a new wipe, disinfect the Kosmos ECG patient cable, starting from the connector end to the clips. Observe the required wet contact time. Monitor the Kosmos ECG patient cable for wet appearance.

  • Page 87: Recycling And Disposal

    In cases where Kosmos Bridge and/or Kosmos Torso has been exposed to biologically hazardous material, EchoNous recommends using biohazard containers and in compliance with federal and local regulations. Kosmos Bridge and Kosmos Torso should be taken to a waste center which specializes in the disposal of biohazard waste. Troubleshooting Preventive inspection, maintenance, and calibration •...
  • Page 88 Troubleshooting • The KOSMOS battery is not replaceable. If KOSMOS is not functioning as designed and intended, contact EchoNous customer support. KOSMOS User Guide...
  • Page 89 KOSMOS Maintenance This page left intentionally blank KOSMOS User Guide...

  • Page 90: Safety

    ISO 14971:2007/(R)2010 Medical devices - Application of risk management to medical devices 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ANSI AAMI EC53:2013 ECG Trunk Cables And Patient Leadwires KOSMOS User Guide...

  • Page 91: Labeling Symbols

    Tested to comply with FCC None Model P005247 standards FCC ID: 2AU8B-ECHKMOS Class II equipment Class II equipment Ref. No. D.1-9 IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance KOSMOS User Guide...
  • Page 92 Electronic Equipment regulations for disposal (WEEE) Directive 2012/19/EU of the European Parliament IPX7 Kosmos Torso is protected IP Code for degree of against temporary protection immersion in water. IEC 60529 Degrees of protection provided by enclosures (IP...
  • Page 93 Temperature limit range XX is generic Ref. No. 5.3.7 placeholder for specified ISO 15223-1 temperatures Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements KOSMOS User Guide...
  • Page 94 - Part 1: General requirements Stack box this way up This way up Ref. No. 13 ISO 780 Packaging - Distribution packaging - Graphical symbols for handling and storage of packages KOSMOS User Guide...
  • Page 95 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Indicates alternating current Alternating current Ref. No. D.1-1 IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance KOSMOS User Guide...

  • Page 96: Contact Information

    Redmond, WA 98052 Technical Support (toll free): (844) 854 0800 Sales (toll free): (844) 854 0800 Email: support@EchoNous.com Website: www.EchoNous.com European Economic Area Authorized Representative: Advena Ltd Tower Business Centre 2nd Flr, Tower Street Swatar, BKR 4013 Malta KOSMOS User Guide...

  • Page 97: Biological Safety

    Reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and limit exposure time, KOSMOS provides controls that can be manipulated during the exam to optimize the results of the exam.
  • Page 98 Thermal index TI is an estimate of the temperature increase of soft tissue or bone. There are three TI categories: TIS, TIB, and TIC. However, since KOSMOS is not intended for transcranial applications, the TI for cranial bone at the surface (TIC) is not available for display on the system.

  • Page 99: Acoustic Output Tables

    0.2 as outlined by the standards. All MI and TI values displayed on KOSMOS will not exceed the maximum global values (listed in the Track 3 acoustic output tables) by more than 0.2.
  • Page 100 NOTE 5 Unshaded cells should have a numerical value. The equipment setting related to the index has to be entered in the operating control section. NOTE 6 The depths apply to NON-SCANNING MODES, while the depths apply pii,α sii,α to SCANNING MODES. KOSMOS User Guide...
  • Page 101 NOTE 5 Unshaded cells should have a numerical value. The equipment setting related to the index has to be entered in the operating control section. NOTE 6 The depths apply to NON-SCANNING MODES, while the depths apply pii,α sii,α to SCANNING MODES. KOSMOS User Guide...
  • Page 102 NOTE 5 Unshaded cells should have a numerical value. The equipment setting related to the index has to be entered in the operating control section. NOTE 6 The depths apply to NON-SCANNING MODES, while the depths apply pii,α sii,α to SCANNING MODES. KOSMOS User Guide...
  • Page 103 NOTE 5 Unshaded cells should have a numerical value. The equipment setting related to the index has to be entered in the operating control section. NOTE 6 The depths apply to NON-SCANNING MODES, while the depths apply pii,α sii,α to SCANNING MODES. KOSMOS User Guide...
  • Page 104 NOTE 5 Unshaded cells should have a numerical value. The equipment setting related to the index has to be entered in the operating control section. NOTE 6 The depths apply to NON-SCANNING MODES, while the depths apply to pii,α sii,α SCANNING MODES. KOSMOS User Guide...
  • Page 105 NOTE 5 Unshaded cells should have a numerical value. The equipment setting related to the index has to be entered in the operating control section. NOTE 6 The depths apply to NON-SCANNING MODES, while the depths apply to pii,α sii,α SCANNING MODES. KOSMOS User Guide...

  • Page 106: Measurement Accuracy

    +/- 2% of the displayed value. Control effects KOSMOS does not provide the user with direct control of acoustic output power. KOSMOS has been designed to automatically adjust the output to ensure that acoustic limits are not exceeded in any imaging mode. Since there is no direct user control for output, the user should rely on controlling exposure time and scanning technique to implement the ALARA principle.

  • Page 107: Transducer Surface Temperature Rise

    KOSMOS, with a fully charged battery, provides about two hours of continuous operation. • The KOSMOS heart rate calculation is accurate to within ±10% or ±5/min, whichever is greater for regular heart rates in the specified range per 60601-2-27 Heart Rate Accuracy Requirement.

  • Page 108: Ergonomics

    KOSMOS provides the following sweep speeds: 20 mm/sec, 25 mm/sec, 35 mm/sec, and 50 mm/sec. • When calculating heart rate, KOSMOS is capable of rejecting tall T-waves (as false QRS peaks) up to amplitudes that are up to 75% of QRS amplitude. Ergonomics...

  • Page 109: Electromagnetic Compatibility

    To avoid the risk of a burn hazard, do not use Kosmos Torso with high-frequency surgical equipment. Such a hazard may occur in the event of a defect in the high-frequency surgical neutral electrode connection.

  • Page 110: Electromagnetic Emissions

    If the System is found to cause or respond to interference follow the guidelines in the warning section above. KOSMOS User Guide...

  • Page 111: Electromagnetic Immunity

    5 cycles IEC 61000-4- 70% U (30% 70% U (30% dip in U dip in U 25 cycles 25 cycles <5% U <5% U (>95% dip in (>95% dip in ) for 5 sec ) for 5 sec KOSMOS User Guide...
  • Page 112 80MHz IEC 61000-4- part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d = 1.2 KOSMOS User Guide...
  • Page 113 ESD and may require manual intervention. If ESD results in a System error, unplug the probe and plug back in to restore operation. Conducted RF energy may cause noise in the ECG waveform. If noise is detected on the ECG waveform, disconnect KOSMOS from AC power. KOSMOS User Guide...

  • Page 114: Separation Distances

    • IC ID: 25670-ECHKMOS KOSMOS contains an intentional radiator approved by the FCC under the FCC ID numbers, as shown above. KOSMOS complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) KOSMOS may not cause harmful interference and (2) KOSMOS must accept any interference received, including interference that may cause undesirable operation.

  • Page 115: Class B Device

    Operations in the 5.15-5.25GHz band are restricted to indoor usage only. Class B device KOSMOS has been tested and found to comply with the limits for a class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 116: Standards

    CAN ICES-3 (B)/NMB-3(B) Standards HIPAA KOSMOS includes security settings that help you to meet the applicable security requirements listed in the HIPAA standard. Users are ultimately responsible for ensuring the security and protection of all electronic protected health information collected, stored, reviewed, and transmitted on the system.
  • Page 117 Safety This page left intentionally blank KOSMOS User Guide...

  • Page 118: Specifications

    Specifications CHAPTER 10 System specifications Kosmos Torso dimensions Height: 150mm (excluding cable (the hard plastic housing length)) Width: 56mm Depth: 35mm Weight: 260 grams (with ferrite-equipped cable) Cable dimensions: 1.8 meters Kosmos Bridge dimensions Height: 146mm Width: 216mm Depth: 59mm...

  • Page 119: Ecg Cable

    Width: 53.5mm Depth: 34.2mm Weight: 260 grams DC cable dimension: 1 meter Environmental operating and storage conditions Kosmos Bridge and Kosmos Torso are intended to be used and stored in normal ambient conditions inside a medical facility. KOSMOS User Guide...

  • Page 120: Operating, Charging, Transport, And Storage Condition Ranges

    A cold or hot surface may burn the patient. Only operate, charge, and store Kosmos Bridge and Kosmos Torso within the approved environmental parameters. When used in high ambient temperatures (such as 40 deg C), the KOSMOS safety feature may disable scanning to maintain safe touch temperature.

  • Page 121: Internal Batteries

    Li-Ion coin cell battery: 3V, 5.8mAh Battery charging time: The time to charge the battery from 0% to 90% of capacity is ~3 hours Battery life: A fully charged battery will provide ~2 hours of uninterrupted scanning KOSMOS User Guide...

  • Page 122: It Network

    Hardware specification 802.11 a/b/g/n/ac, Bluetooth 4.2 or later Software Specification KOSMOS is connected to PACS by the DICOM standard. For details, refer to the DICOM Conformance Statement that is on the USB flash drive. Network for connecting the device To ensure safety, use an IT network that is isolated from the external environment by a firewall.

  • Page 123: Specifications For The Connection

    KOSMOS from the WLAN. However, KOSMOS can initiate a connection to servers on the WLAN and beyond. The KOSMOS USB port can only be used to export data to a USB memory stick. Computer access to the device through the USB port is blocked.

  • Page 124: It Network Failure Recovery Measures

    Incorrect data Misdiagnosis Integrity of the transmitted to a data is ensured by PACS the TCP/IP and DICOM protocols used by KOSMOS. Unable to get the Incorrect exam KOSMOS has the time from a time data capability of server entering data and time manually.
  • Page 125 • When a setting of the IT network to which KOSMOS is connected has been changed, check that the change does not affect it, and take measures, if necessary. Changes to the IT network include: Changing the network configuration (IP address, router, and so on) ...

  • Page 126: Glossary

    The device needs to have a secure connection for data transfer. Once an exam is archived, it cannot be edited. At this point, it is safe to purge the exam from KOSMOS to create more room for new studies. Arrow...
  • Page 127 Once archived, you cannot edit anything. If the clinician does not complete an exam, KOSMOS will automatically complete the exam when KOSMOS is turned off.
  • Page 128 Term Description Frozen state The state KOSMOS gets into when you tap the Freeze button in live imaging. During the frozen state, you can add annotations to one frame of the cine and save the still image. The measurements only stay on one frame of the cine, but the annotations will persist in the whole cine.
  • Page 129 A report consists of details of an exam, along with the notes entered by the clinician. Review This is the state of KOSMOS where you can review and edit patient data if it has not been archived. Region of Interest. The ROI refers to the bounded region in the field of view where color flow information is depicted.
  • Page 130 This page left intentionally blank KOSMOS User Guide...

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