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Safety

110

KOSMOS User Guide

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Summary of Contents for KOSMOS

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Page 3: ...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 ...

Page 4: ...ting 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 Connectio...

Page 5: ...orkflow 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...

Page 6: ...ting 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 Kosmo...

Page 7: ...ctromagnetic 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 Environmen...

Page 8: ...reless 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 ...

Page 9: ...ated 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 ...

Page 10: ...oint 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 abdom...

Page 11: ...traindications 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 ph...

Page 12: ...e 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 t...

Page 13: ... 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...

Page 14: ...tomer 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 ...

Page 15: ...s 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 com...

Page 16: ...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 ...

Page 17: ...res 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 KOSMO...

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Page 19: ...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 ...

Page 20: ...Using KOSMOS 12 KOSMOS User Guide Kosmos Torso Side Camera Handle Volume controls USB port Orange orientation marker Kosmos Torso cable ...

Page 21: ...KOSMOS User Guide 13 Kosmos hardware KOSMOS power supply KOSMOS Bridge stand Kosmos ECG patient cable Connector Trunk cable Yoke Leadwires Clips attachment point for the ECG electrodes ...

Page 22: ... when listening to digital auscultation signals The binaural headset includes a detachable USB digital to analog converter Before each use inspect Kosmos Torso for damage such as cracks splitting or sharp edges If damage is evident discontinue using Kosmos Torso and contact your EchoNous representative Use only accessories recommended by EchnoNous Do not connect Kosmos Torso into any device other ...

Page 23: ...To connect the power supply to Kosmos Bridge 1 Attach the Kosmos power supply into the USB slot on Kosmos Bridge 2 Then plug the other end into an electrical outlet 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 disa...

Page 24: ...ge stand 1 Unfold the stand and put it on a flat surface 2 Place Kosmos Bridge on it 3 Adjust the angle to the best viewing position 4 Tighten the screws Turning Kosmos Bridge on and off Turning on Kosmos Bridge and Kosmos Torso To turn on Kosmos Bridge and Kosmos Torso 1 Press the Power button ...

Page 25: ...ess the Power button 2 Do one of the following When prompted tap OK Wait the few seconds for KOSMOS to turn itself off If the administrator has set a PIN for security purposes type it when prompted However if you need to start scanning right away tap EMERGENCY To save patient data after scanning type the PIN to log on to the device then you can save the exam ...

Page 26: ...Using KOSMOS 18 KOSMOS User Guide General interaction Home screen Lung scan Heart scan Patient list Exam list Settings screen User guides and clinical how to videos Abdominal scan ...

Page 27: ...ltrasound tab B mode Imaging screen Three signal tab Color mode M mode Gain BMI Depth TGC Freeze Review Save image Save clip ECG gain Ultrasound ECG DA Sweep Speed Exam Organization Patient ID Date Battery remaining Scan area DA gain Storage remaining Patient ...

Page 28: ...d controls 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 M mode Color mode BMI Depth Gain TGC Near gain and far gain ...

Page 29: ...odify the amplitudes of the ECG waveform by increasing and decreasing the ECG gain Determines the number of waveforms displayed Choose the appropriate sweep speed shared between ECG and DA A lower sweep speed displays more waveforms while a higher sweep speed displays fewer waveforms but provides greater details of individual waveforms ECG slider is turned on ...

Page 30: ...odify the amplitudes of the DA waveform by increasing and decreasing the DA gain DA slider is turned on The DA audio plays in synchronization with the visualization of the DA waveform You can adjust the volume of the audio and mute the audio with the physical buttons on Kosmos Bridge ...

Page 31: ... of the imaging screen Patient name Displays the patient name in the top bar of the imaging screen Patient ID Displays the patient ID in the top bar of the imaging screen 4 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 KOSMOS captures cine buffer frames for the number of sec...

Page 32: ... 1 From the Home screen tap SETTINGS 2 Tap ECG DA Signals 3 Tap the layout that best suit your needs Setting the language date and time 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 1 From the Home screen tap SETTINGS 2 Tap Language Date and Time 3 From the Language list tap the ...

Page 33: ...ghtness level you want Configuring administrator preferences Only the KOSMOS Administrator can configure these settings Managing security settings You have the option of setting up an administrator PIN a clinical user PIN or no PIN at all If you do choose to set up PINs and then forget your PIN you can still scan using the emergency feature but you won t be able to save the exam If KOSMOS is only ...

Page 34: ...p SETTINGS then Administration 2 Tap Security 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 If you choose Can scan in Emergency mode Can save review patient data Can access admin settings No PIN Anyone Anyone Anyone Admin ...

Page 35: ... information in the DICOM connection area KOSMOS AE title KOSMOS Application Entity title PACS AE title Archive server s Application Entity title PACS IP address Archive server s unique identifier PACS port number Archive server s port number 5 To make sure the connection is working on an active profile tap one of the following New systems do not come with any configured profiles You cannot have t...

Page 36: ...he following options On Off The auto archive is switched off by default This means that all the controls except the on off switch are disabled and cannot be edited If you turn the switch on all the controls are enabled and can be edited Archival frequency Completion of exam The archival time selector is disabled Daily Only the time section of the archival time selector is enabled Weekly The comple...

Page 37: ...pdate available You can also choose to have KOSMOS automatically download and install any updates To manually check to see if there is a software update available 1 Make sure you are connected to your network see IT Network 2 From the Home screen tap Settings 3 Tap Admin 4 Tap Updates 5 Tap CHECK FOR UPDATES To set KOSMOS to automatically check and or install updates 1 From the Home screen tap Set...

Page 38: ...en tap Settings 2 Tap Administration 3 Tap Network and Internet 4 Choose the Android settings that best suit your needs Setting the sleep mode interval 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 ...

Page 39: ... the Home screen tap Settings 2 Tap Administration 3 Tap About 4 If you have not yet registered KOSMOS tap Register Registering KOSMOS To register KOSMOS to the EchoNous cloud 1 Make sure you are connected to your network see IT Network 2 From the Home screen tap Settings 3 Tap Admin 4 Tap About 5 Tap REGISTER Resetting KOSMOS to the factory settings You can restore KOSMOS to its factory settings ...

Page 40: ...s 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 A copy of the EchoNous EU Declaration of Conformit...

Page 41: ...ng Use Restriction This device is restricted to indoor use when operating in the 5150 to 5350 MHz frequency range 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 ...

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Page 43: ...ngle 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 The leadwires and associated clips are connected to the patient using the standard RA LA LL configuration This allows at any one time for a single ECG lead either...

Page 44: ...s the recording visualization storage analysis and sharing of digital recordings of heart lung or abdominal sounds The visualization of sounds in DA is accomplished with waveforms that are presented to the user in real time while the acquisition is taking place In the case of heart sounds these waveforms are also known as phonocardiograms Benefits of using ECG and DA signals with ultrasound Ultras...

Page 45: ...ronic implantable devices The Kosmos ECG patient cable is not defibrillation proof The KOSMOS ECG functionality is a Type BF KOSMOS ECG functionality is not for use in situations such as patient monitoring where the patient has exposed leadwires that are in direct cardiac contact Conductive parts of electrodes and associated connectors for Type BF Applied Parts including the neutral electrode shou...

Page 46: ...ent making sure they are placed symmetrically opposite from each other and match the color coding USA recommendation American Heart Association RA Right arm white clip LA Left arm black clip LL Left leg red clip IEC recommendation R Right arm red clip L Left arm yellow clip F Left leg green clip 2 Plug the connector end of the Kosmos ECG patient cable into the magnetic slot on Kosmos Torso ...

Page 47: ...1 Plug the USB end of the Kosmos binaural headset into the USB slot on Kosmos Bridge 2 Put the headset on 1 On Kosmos Bridge tap the Signals tab 2 Tap DA to turn it on 3 From the top of the screen slide your finger down to see the volume control 4 Adjust the volume The DA signal is built into KOSMOS there are no external microphones sensors to hook up To listen to the DA signal you must plug the K...

Page 48: ...on on the bottom right side of the screen Signal scrolling The ECG and DA signals scroll from left to right The newest signals appear on the left and are indicated by the orange cursor 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 ...

Page 49: ...ts saved so if you turn off any of the signals while in live imaging mode and you save an image or clip only the signals displayed on the screen are saved For more information on viewing the ECG and DA signals when reviewing a saved exam or clip refer to Reviewing an Exam Archiving and exporting ECG and DA waveforms When you archive exams to the PACS server the ECG and or DA waveforms are embedded...

Page 50: ...t only the operator handles the system Avoid placing Kosmos Bridge on the patient during use The maximum temperature of the Kosmos Torso scan head may be greater than 41C but is less than 43C when in contact with the patient for normal use Special precautions should be considered when using the transducer on children or on other patients who are sensitive to higher temperatures To reduce the risk ...

Page 51: ...e images and clips Add edit and delete annotations and notes Scan patient Review exam Things you can do while reviewing Delete images and clips Add edit and delete annotations and notes Generate report Archive exam Complete save exam Archive export exam Optional step Start scanning immediately then go back and connect the exam to the correct patient Optional step ...

Page 52: ...Add and delete images and clips Add edit and delete annotations and notes Scan patient Review exam Things you can do while reviewing Delete images and clips Add edit and delete annotations and notes Generate report Archive exam to PACS Export exam to USB Complete save exam Archive exam Optional step ...

Page 53: ... From the Exam list tap the Add icon and then tap SCAN Searching for an exam To search for an exam 1 From the Exam screen tap the Search icon 2 Type the search criteria such as date patient name DOB or MRN 3 From the list of search results tap the exam you want to view Deleting exams To delete one or more exams 1 From the list of exams tap one or more circles to the left of the exam The circle tur...

Page 54: ...con 2 Tap Complete 3 At the prompt tap OK Managing patient data Adding a new patient To add a new patient from the Home screen 1 From the Home screen tap PATIENTS 2 Tap the Add icon 3 Enter the patient information and tap SAVE when you are done Searching for a patient To search for a patient 1 From the Home screen tap PATIENTS 2 Tap the Search icon 3 Type the search criteria for the patient you ar...

Page 55: ...edit a patient record 1 From the Home screen tap PATIENTS 2 From the Patient list double tap the patient record you want to edit 3 Enter the patient information and tap SAVE when you are done Merging two patient records If you have saved multiple patients with the same name and they are actually the same patient you can merge all the exams of that patient into one patient record so it is easier to...

Page 56: ...want to merge 6 Tap NEXT 7 Tap the fields to keep for the patient 8 Tap MERGE then tap OK Deleting patient records To delete all patient records without exams 1 From the Home screen tap PATIENTS 2 Tap the More options icon 3 Tap Delete all patients without exams To delete selected patient records 1 From the Home screen tap PATIENTS 2 Tap one or more patient names from patient list 3 Tap the Trash ...

Page 57: ...ions by assigning a brightness level based on the echo signal amplitude M mode 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 Color M mode Gain BMI Depth TGC ...

Page 58: ...ode along with M mode specific controls like M line and sweep speed To change to M mode tap M Mode M Line 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 Sweep speed ...

Page 59: ...e system s color acquisition To turn Color mode on and off tap Color Color box You can move and resize the color box during imaging The maximum axial and lateral size of the box may be limited depending on the organ depth or other settings To move the color box drag it to another position To resize the color box move one of the corners to make it either taller or wider Color box Color B mode contr...

Page 60: ...r Flow sensitivity Three flow sensitivity selections are available to optimize for low medium or high velocity flow To change the flow sensitivity tap the Flow sensitivity icon one two or three times to set the appropriate velocity flow Wall filter With the wall filter the higher the level the more it blocks the low frequency flow To change the wall filter tap the Wall filter icon one two or three...

Page 61: ...OSMOS 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 Low default Medium High When you adjust the BMI it changes the penetration signal for the ultrasound parameters so if you have a patient with a high BMI you will want to increase the BMI and vice versa To adjust BMI tap BMI and select on...

Page 62: ...actor is shown near the magnifying glass as well as the orange color of the depth scale along the side image area You can freeze while zoomed and can unzoom and zoom while frozen Freezing an image To freeze an image tap the Freeze icon The annotation tools automatically display on the left side of the screen Acquiring images and clips To acquire an image From the Imaging screen tap the Save image ...

Page 63: ...Performing an Exam 56 KOSMOS User Guide When you start a new exam When you archive the in progress exam After a few minutes When you turn off Kosmos Bridge ...

Page 64: ...eview during an exam tap the Exam review icon To start a review for a completed exam do one of the following From the Home screen tap EXAMS then tap the exam you would like to review From the list of patients find the patient then tap the exam you would like to review Annotating images and clips You can add annotations during the exam when the image is frozen or after you have completed the exam A...

Page 65: ...it Clips screen While scanning a patient 1 Tap the Freeze icon 2 Add your annotations 3 Tap the Save image or Save clip icon 4 Move the image or clip After scanning a patient 1 Tap the Exam review icon 2 Tap the image clip you want to annotate 3 Tap the Edit icon From the Home screen 1 Tap Exam Annotation tools ...

Page 66: ...ping the Hide overlay icon on saved images and clips Measuring with the caliper tool When a caliper is not selected and you start dragging one of the two end points of the caliper the caliper will become selected and will resize based on where you are dragging it To place a measurement 1 From the Edit image or Edit clip screen tap DISTANCE and a caliper appears in the center of the image or clip 2...

Page 67: ...To return to normal tap the magnifying glass Also zoom factor is shown near magnifying glass as well as orange color of depth scale along the side 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 ...

Page 68: ...list down to reveal the filter options Tap the Filter icon on top of the thumbnail list to reveal the filter options Tap the More options icon in the title bar and tap Filter images and clips When the filter options are visible a blue check icon will be shown next to Filter images and clips When you select a filter only the tagged images clips are visible in the thumbnail list You can tag images c...

Page 69: ...ed circle displays to indicate how many images and clips you have selected To clear the red check tap it again To clear the selections tap the More options icon and tap Select images clips Trimming and saving images and clips To trim and save a clip 1 Tap the Freeze icon 2 Move the right and left end points of the cine clip 3 Tap the Clip icon To trim and save an image 1 From the Exam Review scree...

Page 70: ...on by tapping the arrow button Just tap the arrow button to expand the section again You can edit each section of the report with the exception of the patient information This is read only and cannot be changed Editing exam information The exam information section displays the exam related information that was entered before the scan To edit the exam information 1 Tap the Edit icon 2 Make any nece...

Page 71: ...xt note A delete button displays 2 Tap DELETE and when prompted tap OK Exporting images and clips to a USB drive When exporting an images and clips use a micro USB or adapter You can export images and clips from one exam or multiple exams To export images and clips from one exam to a USB drive 1 From the Home screen tap EXAMS 2 Tap a row to select an exam 3 Tap the bookmark icon under each of the ...

Page 72: ...xt to each exam you would like to export 3 Connect the USB drive using the USB c adapter 4 Tap the Export icon on the top of the screen A dialog box appears 5 Select the file type and whether you want all images and clips exported or only the tagged images and clips 6 Tap OK to start exporting to USB drive Completing an exam review To complete an exam 1 Tap COMPLETE 2 When prompted click OK Archiv...

Page 73: ...rding to the default archive options For more information see Managing PACS archives To archive an exam from the Exam review screen 1 From the Exam review screen tap ARCHIVE 2 From the Archive exam to PACS server screen select which images and clips you want to archive and if you would like to include a report 3 Click OK and when prompted click OK again Deleting an exam To delete an exam from the ...

Page 74: ...KOSMOS User Guide 67 Deleting an exam To delete an exam while reviewing it 1 Tap the More options icon 2 Tap Delete the exam 3 When prompted click OK ...

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Page 76: ...sed skin Some sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals Use market cleared sheaths for clinical applications when Kosmos Torso is likely to be splashed or splattered with blood or other bodily fluids Use market cleared sterile sheaths and sterile coupling gel to prevent cross contamination Do not apply the sheath and coupling gel until you...

Page 77: ... facility In addition the packaging provided with the device may be used for long term storage Storage for transport KOSMOS is intended to be handheld for easy transport Users may use the packaging supplied with the device for transport Consult your EchoNous sales representative for information on approved bags and other accessories Some ultrasound gels may cause an allergic reaction in some indiv...

Page 78: ...PE recommended by the chemical manufacturer such as protective eye wear and gloves Do not skip any steps or abbreviate the cleaning and disinfecting process in any way Do not spray cleaners or disinfectants directly on Kosmos Bridge surfaces or on Kosmos Bridge and Kosmos Torso connectors Doing so may cause solution to leak into KOSMOS damaging it and voiding the warranty Do not attempt to clean o...

Page 79: ...d all other areas of Kosmos Bridge Choose an EchoNous approved wipe from the list in Presaturated wipes 4 If necessary clean Kosmos Bridge with additional wipes to remove all visible contaminants 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 After disinfection examine...

Page 80: ...ace by using an approved presaturated disinfectant wipe Choose an EchoNous approved wipe from the list in Presaturated wipes Always disconnect the USB cable from Kosmos Torso before cleaning and disinfecting After cleaning you must disinfect Kosmos Torso by following the appropriate instructions Always wear protective eye wear and gloves when cleaning and disinfecting any equipment Use only EchoNo...

Page 81: ... and Kosmos Torso starting from the exposed cable wiping toward the Kosmos Torso head to avoid cross contamination 3 Observe the required wet contact time Monitor Kosmos Torso for wet appearance Use at least three wipes to ensure effective disinfection 4 Before reusing Kosmos Torso ensure Kosmos Torso is visibly dry Always disconnect the USB cable from Kosmos Torso before cleaning and disinfecting...

Page 82: ...ened storage container Always disconnect Kosmos Torso from AC mains during cleaning and disinfection Before disinfection clean Kosmos Torso by following the appropriate cleaning instructions in Cleaning to remove all gels fluids and particulates that may interfere with the disinfection process Always use protective eye wear and gloves when disinfecting any equipment When disinfecting Kosmos Torso ...

Page 83: ...he 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 8 Repeat rinsing three times to ensure proper rinsing 9 Air dry or use a soft sterile cloth to dry Kosmos Torso until visibly dry 10 Wipe the strain relief and first 18 inches 45 cm of the Kosmos Torso cable with an approved wipe from the list in Presa...

Page 84: ...e cable is an essential step before effective disinfection Before cleaning the Kosmos ECG patient cable read the following warnings and cautions To clean the Kosmos ECG patient cable 1 After each use disconnect the cable from Kosmos Torso 2 Remove any accessories attached to or covering the cable such as electrode pads Always disconnect the cable from Kosmos Torso before cleaning and disinfecting ...

Page 85: ...d cleaning brush vigorously brush all surfaces of the ECG clips while immersed in the Enzol solution until visibly clean 7 Actuate any movable parts while immersed In addition flush crevices using a slip tip syringe filled with prepared cleaning detergent 8 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 ...

Page 86: ...s to ensure effective disinfection 5 Examine the cable for damage such as insulation wearing or discoloration If damage is evident discontinue using the Kosmos ECG patient cable 6 Before reusing the cable ensure the cable is visibly dry Binaural Headset The following cleaning and disinfection method must be followed for Binaural Headset Always disconnect the USB cable from KOSMOS Torso before clea...

Page 87: ...ctronic equipment 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 calibrati...

Page 88: ...KOSMOS User Guide 81 Troubleshooting The KOSMOS battery is not replaceable If KOSMOS is not functioning as designed and intended contact EchoNous customer support ...

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Page 90: ...l performance IEC 60601 1 2012 Edition 3 1 IEC 60601 1 2 2014 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral Standard Electromagnetic disturbances Requirements and tests IEC 62304 2015 Medical device software Software life cycle processes ISO 14971 2007 R 2010 Medical devices Application of risk management to medical devices 10993 1...

Page 91: ...ling and information to be supplied Part 1 General requirements Manufacturer s declaration of product compliance with applicable EEC directives and the Notified Body reference number CE Marking Ref Appendix 12 93 42 EEC EU Medical Device Directive Tested to comply with FCC standards None Class II equipment Class II equipment Ref No D 1 9 IEC 60601 1 Medical electrical equipment Part 1 General requ...

Page 92: ...eral requirements for basic safety and essential performance Do not dispose of this product in normal trash or landfill refer to local regulations for disposal Separate collection Annex IX Waste Electrical and Electronic Equipment WEEE Directive 2012 19 EU of the European Parliament IPX7 Kosmos Torso is protected against temporary immersion in water IP Code for degree of protection IEC 60529 Degre...

Page 93: ...evice labels labeling and information to be supplied Part 1 General requirements Date of manufacture Date of manufacture Ref No 5 1 3 ISO 15223 1 Medical devices Symbols to be used with medical device labels labeling and information to be supplied Part 1 General requirements Acceptable temperature range XX is generic placeholder for specified temperatures Temperature limit Ref No 5 3 7 ISO 15223 1...

Page 94: ...o be supplied Part 1 General requirements Acceptable atmospheric pressure range XX is generic placeholder for specified kPa Atmospheric pressure limitation Ref No 5 3 9 ISO 15223 1 Medical devices Symbols to be used with medical device labels labeling and information to be supplied Part 1 General requirements Stack box this way up This way up Ref No 13 ISO 780 Packaging Distribution packaging Grap...

Page 95: ...C 60601 1 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 ...

Page 96: ...h Avenue NE Building B Suite 200 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 ...

Page 97: ... the results of the exam The ability of the user to abide by the ALARA principle is important Advances in diagnostic ultrasound not only in the technology but in the applications of that technology have resulted in the need for more and better information to guide users The output display tables are designed to provide that important information There are a number of variables which affect the way...

Page 98: ... is actually occurring a high index reading should be taken seriously Every effort should be made to reduce the possible effects of a high index reading Limiting exposure time is an effective way to accomplish this goal There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity These controls are related to the techniques that a user mi...

Page 99: ...PUT DISPLAY ACCURACY Output display accuracy of the bioeffect indices MI and TI is dependent on the uncertainty and precision of the measurement system engineering assumptions within the acoustic model used to calculate the parameters and variability in the acoustic output of the systems EchoNous also compares both internal and third party acoustic measurements and confirms that both measurements ...

Page 100: ...ii α W cm2 2 48 99 Ispta α at zpii α or zsii α mW cm2 10 38 Ispta at zpii or zsii mW cm2 19 64 pr at zpii MPa 2 1 38 Operating controls Component 1 UTP21 Component 2 UTP22 NOTE 1 Only one operating condition per index NOTE 2 Data should be entered for at surface and below surface both in the columns related to TIS or TIB NOTE 3 If the requirements of 201 12 4 2a are met it is not required to enter...

Page 101: ...W cm2 2 54 17 Ispta α at zpii α or zsii α mW cm2 17 24 Ispta at zpii or zsii mW cm2 31 29 pr at zpii MPa 2 1 43 Operating controls Component 1 UTP73 Component 2 UTP74 NOTE 1 Only one operating condition per index NOTE 2 Data should be entered for at surface and below surface both in the columns related to TIS or TIB NOTE 3 If the requirements of 201 12 4 2a are met it is not required to enter any ...

Page 102: ... mW cm2 16 71 Ispta at zpii or zsii mW cm2 31 29 pr at zpii MPa 45 72 Operating controls UTP4 NOTE 1 Only one operating condition per index NOTE 2 Data should be entered for at surface and below surface both in the columns related to TIS or TIB NOTE 3 If the requirements of 201 12 4 2a are met it is not required to enter any data in the columns related to TIS or TIB NOTE 4 If the requirements of 2...

Page 103: ...mW cm2 13 64 Ispta at zpii or zsii mW cm2 38 22 pr at zpii MPa 1 06 Operating controls UTP5 NOTE 1 Only one operating condition per index NOTE 2 Data should be entered for at surface and below surface both in the columns related to TIS or TIB NOTE 3 If the requirements of 201 12 4 2a are met it is not required to enter any data in the columns related to TIS or TIB NOTE 4 If the requirements of 201...

Page 104: ...8 npps 2 16 Ipa α at zpii α W cm2 2 82 58 Ispta α at zpii α or zsii α mW cm2 108 55 Ispta at zpii or zsii mW cm2 152 01 pr at zpii MPa 2 1 59 Operating controls Component 1 UTP4 Component 2 UTP55 NOTE 1 Only one operating condition per index NOTE 2 Data should be entered for at surface and below surface both in the columns related to TIS or TIB NOTE 3 If the requirements of 201 12 4 2a are met it ...

Page 105: ...s 2 16 Ipa α at zpii α W cm2 2 59 28 Ispta α at zpii α or zsii α mW cm2 57 37 Ispta at zpii or zsii mW cm2 101 13 pr at zpii MPa 2 1 44 Operating controls Component 1 UTP4 Component 2 UTP57 NOTE 1 Only one operating condition per index NOTE 2 Data should be entered for at surface and below surface both in the columns related to TIS or TIB NOTE 3 If the requirements of 201 12 4 2a are met it is not...

Page 106: ...as follows M mode distance measurement M mode distance measurements shall be accurate to within 3 of the displayed value M mode time measurement accuracy M mode time measurements shall be accurate to within 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...

Page 107: ...commended ECG electrodes Use a fluid resistant foam backed electrode such as 3M Red Dot Clear Plastic Monitoring Electrode 2235 KOSMOS uses single ECG filter from 0 65 Hz 47 5 Hz KOSMOS with a fully charged battery provides about two hours of continuous operation The KOSMOS heart rate calculation is accurate to within Â 10 or Â 5 min whichever is greater for regular heart rates in the specified ra...

Page 108: ...se occasional discomfort in your thumbs fingers hands arms shoulders eyes neck back or other parts of your body However if you experience symptoms such as constant or recurring discomfort soreness pain throbbing aching tingling numbness stiffness burning sensation muscle fatigue weakness or limited range of motion do not ignore these warning signs Promptly see a qualified health professional Sympt...

Page 109: ...d device or increasing the separation distance between the devices Contact hyperlink EchoNous customer support or your EchoNous distributor for further information EchoNous does not recommend the use of high frequency electromedical devices in proximity to its systems EchoNous equipment has not been validated for use with high frequency electrosurgical devices or procedures Use of high frequency e...

Page 110: ...manufacturer s declaration electromagnetic emissions Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 TheSystem uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A Harmonic emissions IEC 61000 3 2 Class A The System ...

Page 111: ...or power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth 1kV differential mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 1 95 dip ...

Page 112: ... or hospital environment 2 3 Conducted RF IEC 61000 4 6 3 Vrms 150kHZ 80MHz 3 Vrms6 Portable and mobile RF communications equipment should be used no closer to any 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 TABLE 9 9 Guidance and manufacturer s declara...

Page 113: ...ateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above the system should be observed to verify normal ope...

Page 114: ...paration distances between portable and mobile RF communications equipment and the EchoNous System Rated maximum output power of transmitter W Separation distance according to frequency of transmitter 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 12 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output p...

Page 115: ...nterference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help KOSMOS has been verified to comply with the limits for a class B computing...

Page 116: ...CES 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 The Health Insurance Portability and Accountability Act Pub L No 104 ...

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Page 118: ...ions 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 Weight 657 grams Binaural headset Length 800mm Width 120mm Depth 25mm ...

Page 119: ...m Weight 35 grams Power supply Length 117 5mm 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 ...

Page 120: ...6A 4 6A 4 4A 4A 3 6A 3A Operating Transport Storage Temperature C 0C to 40C 20 C to 60 C Relative humidity non condensing 15 to 95 15 to 95 Pressure 62 kPa to 106 kPa 62 kPa to 106 kPa After storage at extreme temperatures check the Kosmos Torso surface temperature before applying to a patient A cold or hot surface may burn the patient Only operate charge and store Kosmos Bridge and Kosmos Torso w...

Page 121: ...s Kosmos Bridge Li Ion main battery 3 6V 6 4 Ah 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 ...

Page 122: ... communication Setting KOSMOS time correctly by inquiring the network time service Connection specifications 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 t...

Page 123: ...e A network entity cannot initiate a connection to 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 The following TCP IP ports are used for outgoing communication to the WLAN Port for DICOM communication specified by ...

Page 124: ... it After the IT network has returned to stable the user can reinitiate the transfer of data Delay of transmis sion to a PACS Incorrect data transmitted to a PACS Misdiagnosis Integrity of the data is ensured by the TCP IP and DICOM protocols used by KOSMOS Unable to get the time from a time server Incorrect exam data KOSMOS has the capability of entering data and time manually Incorrect time data...

Page 125: ...and suitable countermeasures were put in place IEC 80001 1 2010 provides guidance for addressing these risks 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 Connecting additional items Disconnecting i...

Page 126: ...s displays as an overlay on the image clip Auscultation Auscultation is listening to the internal sounds of the body usually using a stethoscope for the purpose of examining the circulatory and respiratory systems heart and breath sounds as well as the gastrointestinal system bowel sounds BMI Body mass index B mode The Kosmos Torso array scans a plane through the body and produces a 2D image on th...

Page 127: ... medical imaging It s an all encompassing data transfer storage and display protocol built and designed to cover all functional aspects of contemporary medicine PACS functionality is DICOM driven ECG Electrocardiogram Electrocardiography is the process of recording the electrical activity of the heart over a period of time using electrodes placed over the skin These electrodes detect the tiny elec...

Page 128: ...provides the trace Measurement A measurement is a distance or area measurement on images with no inference to underlying anatomy A measurement overlay shows the tool such as a caliper or ellipse and the measured values PACS Picture Archiving and Communication Systems PACS refer to medical systems hardware and software built to run digital medical imaging The main components of PACS include digital...

Page 129: ...orts Snackbar The snackbar is a brief message that displays on the bottom of many KOSMOS screens You don t have to act on the messages and they automatically go away after a short period of time Study A study is a collection of one or more series of medical images and presentation states that are logically related for diagnosing a patient Each study is associated with one patient A study may inclu...

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