EchoNous EchoNous Bladder User Manual Download Page 100

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EchoNous Bladder & Vein User Guide

M
mains charger

maintenance

Measurement

accuracy

B-mode

microphone

N
navigate .......................................................See touch screen
P
package contents

patient environment

patients

Power

button

sources

R
recommended gel

recording

references

S
safety

biological

contraindications

service.......................................................... See maintenance

setup

shutdown

solvents

sterile sheaths

support

T
touch screen

navigating

trademarks

training

turn off

turn on

U
ultrasound

gel

risks

User Manual

conventions

version

Summary of Contents for EchoNous Bladder

Page 1: ...P003948 007 Rev A March 2021 www EchoNous com User Manual ...

Page 2: ...INTENTIONALLY LEFT BLANK ...

Page 3: ...cations 8 Patient environment 9 Cautions warnings and contraindications 9 Warnings 10 Cautions 12 Contraindications 13 Labeling 14 Contact information 19 United States 19 European economic area 20 Australia 20 Trademarks and document copyright 20 CHAPTER 2 Getting Started 23 Unpacking the boxes 23 Options 23 Connecting and disconnecting the power supply 23 Setting up the system 24 Basic device con...

Page 4: ...r volume 40 Phantom mode 42 Abdominal Ultrasound imaging 42 Ultrasound presets 43 Ultrasound scanning 43 Ultrasound measurement 44 Ultrasound imaging movies 46 Vascular access 46 Vascular access scanning 47 Enabling depths of 4 and 5 CM 48 Vascular access measurement 48 Vascular access movies 49 Common functions 50 Multiple scans 50 Deleting images 50 Ending saving exams 50 After use 50 Turning th...

Page 5: ...y 66 Power sources 66 Internal battery 66 Power supplies chargers 67 EchoNous stand setup 67 EchoNous AI Station power management 70 EchoNous AI Station troubleshooting 71 Cleaning 71 Disinfection 71 CHAPTER 7 Specifications 73 System dimensions 73 Environmental operating and storage conditions 74 Mode of Operation 74 Power supplies chargers 74 Internal battery 74 Measurement accuracy 75 Degree of...

Page 6: ... Acoustic output 85 CHAPTER 9 Advanced device and IT setup 87 Administrator setup 87 Software updates restrictions 87 User management 87 Multiple device setup 89 Imaging restrictions 89 Data recording restrictions 90 Storage access restrictions 90 CHAPTER 10 References 91 Glossary 92 ...

Page 7: ...e Tap refers to touching the screen quickly with your finger Click refers to pressing and releasing the button on the probe unit 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 t...

Page 8: ...y in the form of pulses in the 2 to 6 MHz range for the EchoNous Bladder probes and in the 6 to 14 MHz range for the EchoNous Vein probe into a patient detects the reflected pulses and processes the information to generate ultrasound images and measure anatomical structures The EchoNous System display is an off the shelf Android tablet approved pre configured and supplied by EchoNous The display c...

Page 9: ...Users must have ultrasound training for abdominal musculoskeletal pediatric small organ and peripheral vessel imaging The System can also be used to obtain an image of the bladder that is used to automatically determine bladder volume Contraindications The System is designed for transcutaneous scanning only Do not attempt intracavitary imaging in particular trans esophageal trans vaginal and trans...

Page 10: ...g other Fetal Abdominal Intra operative specify Intra operative neuro Laparoscopic Pediatric Small organ specify Neonatal cephalic Adult cephalic Trans rectal Trans vaginal Trans urethral Trans oesophageal non cardiac Musculoskeletal conventional Musculoskeletal superficial Intravascular Other specify Cardiac Cardiac adult Cardiac pediatric Intravascular cardiac Trans esophageal cardiac Intra card...

Page 11: ...tal Abdominal Intra operative specify Intra operative neuro Laparoscopic Pediatric Small organ specify Neonatal cephalic Adult cephalic Trans rectal Trans vaginal Trans urethral Trans esophageal non cardiac Musculoskeletal conventional Musculoskeletal superficial Intravascular Other specify Cardiac Cardiac adult Cardiac pediatric Intravascular cardiac Trans esophageal cardiac Intra cardiac Other s...

Page 12: ...erative specify Intra operative neuro Laparoscopic Pediatric Small organ specify Neonatal cephalic Adult cephalic Trans rectal Trans vaginal Trans urethral Trans esophageal non cardiac Musculoskeletal conventional Musculoskeletal superficial Intravascular Other specify Cardiac Cardiac adult Cardiac pediatric Intravascular cardiac Trans esophageal cardiac Intra cardiac Other specify Peripheral vess...

Page 13: ...anatomy and location of the bladder is required Ultrasound training is required if bladder outline adjustments are to be performed Users performing vascular access procedures must have appropriate training in ultrasound guided vascular access Appropriate information on training may be obtained by contacting EchoNous or your local professional body Package contents The EchoNous Bladder carton conta...

Page 14: ... preconfigured with the EchoNous System software A Setup Guide System features The front of the EchoNous Samsung tablet display and probes are shown below FIGURE 2 System features The camera for barcode scanning is on the rear of the display Classifications The System is internally battery powered during scanning The EchoNous Type C Power Supply P005179 classification for Protection against electr...

Page 15: ...ment If fluid is spilled on the probe cable or display immediately remove the fluid with a soft dry cloth Carefully inspect the probe cable USB connector and display connectors for signs of fluid ingress If there are any signs of fluid ingress or if the device exhibits any unusual behavior do not use and contact EchoNous customer support or your EchoNous distributor immediately If required also fo...

Page 16: ...ively with the EchoNous System only Only connect the Power Supplies to a mains supply rated at 100 240V and 50 60Hz Do not use the device or Power Supply if there are signs of damage Be aware of latex allergy Some commercially available transducer covers contain latex Check the connecting cable connectors and System housings before use for cracks or fraying Do not use if damaged No modification of...

Page 17: ... accessories that are specified as being compatible with the EchoNous System Contact EchoNous customer support or your EchoNous distributor for information on compatible accessories and Systems Do not open or modify the EchoNous Power Supply P005179 or any other supplied power supplies Risk of electric shock Connecting electrical equipment to an MSO effectively leads to creating a medical electric...

Page 18: ...n or environment Interference may result in artifacts distortion or degradation of the ultrasound image If the System is found to cause or respond to interference try re orienting the System or the affected device or increasing the separation distance between the devices Contact EchoNous customer support or your EchoNous distributor for further information When using the optional mobile stand the ...

Page 19: ... sterilize any part of the System Minimize application of alcohol based disinfectant to colored overmold materials Long term use may result in material degradation If alcohol based disinfectant is applied to the overmold immediately remove by wiping with a damp cloth Only operate charge and store the System within the approved environmental parameters The System contains sensitive components and c...

Page 20: ...product compliance with applicable EEC directives and the Notified Body reference number CE Marking Ref Appendix 12 93 42 EEC EU Medical Device Directive UL Classified Medical General medical equipment as to electrical shock fire and mechanical hazards only in accordance with ANSI AAMI ES 60601 1 2005 AMD 2012 CAN CSA C22 2 No 6060 1 2008 2014 E509516 Medical Refurbished general medical equipment ...

Page 21: ...al performance Consult instructions for use for important cautionary information such as warnings and precautions Caution Ref No D 1 10 IEC 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Multiple socket outlet is marked with this safety sign and is visible in normal use used in accordance with IEC 60601 1 Cl 16 9 2 1 General warning sign...

Page 22: ...2012 19 EU of the European Parliament IPX1 The probe is protected against effects of vertically falling water IP Code for degree of protection IEC 60529 Degrees of protection provided by enclosures IP Code IPX4 The probe is protected from splashing water no matter the direction IP Code for degree of protection IEC 60529 Degrees of protection provided by enclosures IP Code REF Part or model number ...

Page 23: ...art 1 General requirements Acceptable temperature range XX is generic placeholder for specified temperatures Temperature limit Ref No 5 3 7 ISO 15223 1 Medical devices Symbols to be used with medical device labels labeling and information to be supplied Part 1 General requirements Acceptable humidity range XX is generic placeholder for specified percentages Humidity limitation Ref No 5 3 8 ISO 152...

Page 24: ...ckaging Distribution packaging Graphical symbols for handling and storage of packages Indicates direct current Direct current Ref No D 1 4 IEC 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 ...

Page 25: ...Nous com Rx only Caution Federal USA law restricts this device to sale by or on the order of a physician or any other practitioner licensed by law of the State in which he practices to use or order the device FDA Guidance for Industry Alternative to Certain Prescription Device Labeling Requirements Equipment mass including safe working load XXX indicates specified weight used in accordance with IE...

Page 26: ...32 101 Miller Street North Sydney NSW 2060 Australia Tel 61 2 9959 2400 Trademarks and document copyright EchoNous the EchoNous logo EchoNous Bladder EchoNous Vein and EchoNous AI Station are registered and unregistered trademarks of EchoNous Inc Unauthorized use is strictly prohibited Mopria the Mopria Logo and the Mopria Alliance logo are registered trademarks and service marks of Mopria Allianc...

Page 27: ...EchoNous Bladder Vein User Guide 21 Trademarks and document copyright EchoNous Inc 2020 ...

Page 28: ...Important Information 22 EchoNous Bladder Vein User Guide INTENTIONALLY LEFT BLANK ...

Page 29: ...available with the EchoNous AI Station Not for use in patient area Wireless barcode scanner not available in all countries contact EchoNous customer support or your EchoNous distributor for recommended scanners MODO Stand P004013 with EchoNous power supply and probe connection cable EchoNous AI Station P005149 with EchoNous HUB power supply and necessary cables EchoNous AI Station 2 P006259 with E...

Page 30: ...e with the default settings The default settings are appropriate where there is a single user of the System and patient data is not saved to remote servers The System can be further customized by setting preferences see Settings Basic device control The System communicates with the user in a number of ways Menus Screens and windows Message boxes Icons Navigate by using the touch screen with common...

Page 31: ...tus icons System status icons are shown at the top right of the screen Tablet battery status Wi Fi status Bluetooth status used for wireless printing and barcode scanning Location services The device GPS is active and transmitting Ethernet status For the Samsung S6 and S7 tablets the system control is on the bottom of the screen System notification Initiate bladder volume measurement Initiate abdo...

Page 32: ...nd IT setup Patient Data select the source for patient lists see Advanced device and IT setup Exam Patient Details check to force users to enter patient information before starting a scan Send Anonymized Data to EchoNous check to send anonymized images to EchoNous to enable future product improvements Check with your institution s data policies or legal department before enabling this option Send ...

Page 33: ... default patient type Adult Pediatric Use last selected value or Ask each time Enable 4 to 5 CM Enable setting if depths of 4 to 5 CM are desired Administration Refer to Advanced device and IT setup section for advanced user management and setting up several devices with the same preferences Maintenance provides maintenance related functionality including access to software updates System Settings...

Page 34: ... 11 Tap Home to return to the Home Screen A printer icon will be shown on all bladder and ultrasound images when Network Printing is selected Bluetooth printer setup optional An optional Bluetooth printer is available Turn the wireless printer on and then follow the instructions below to set up the printer 1 From the Home Screen tap Menu and select Settings 2 Tap System Settings then tap Bluetooth...

Page 35: ...upported in some countries Barcode scanning using the device camera is also supported To set up the wireless barcode scanner turn the bar code scanner on and follow the instructions below 1 From the Home Screen tap Menu select Settings and select System Settings 2 Tap Bluetooth 3 Slide the on screen button to the right to turn Bluetooth on 4 Select the bar code scanner to pair it with the system 5...

Page 36: ...current image Image Text Annotation displays the text annotation for the image Image Date and Time displays the date and time of the image Gain and Depth Controls adjust the gain brightness or the depth for the system Orientation Mark corresponds to the orientation marker on the probe Image Gain brightness and depth Done end exam Scan Stop Patient details Preset used Image text annotation Orientat...

Page 37: ...Area area for displaying caliper and volume measurements Ultrasound Image area for displaying ultrasound images Image Thumbnails will be displayed for multiple images in an exam Tap a thumbnail to view an image Bladder volume screens Tap Bladder Volume on the Home screen to start a bladder measurement See FIGURE 9 Bladder scan screens for bladder screen layouts FIGURE 9 Bladder scan screens Patien...

Page 38: ...ation Mark corresponds to the orientation marker on the probe Measured Volume measured volume in milliliters Image Text Annotation displays the text annotation for the image Image Date and Time displays the date and time of the image Exam Icons are displayed depending on the context of the exam Tap to activate the function associated with the icon Ultrasound Image area for displaying ultrasound im...

Page 39: ...for the system Orientation Marker corresponds to the probe orientation marker Done tap to end and save the exam Scan Stop tap to start unfreeze and stop freeze scans Exam Icons are displayed depending on the context of the exam Icons include help print measure movie delete toggling the center line toggling the needle guidance lines and a menu to access other functions such as annotations and notes...

Page 40: ...layed for multiple images in an exam Tap a thumbnail to view an image Recommended ultrasound transmission gel EchoNous recommends the use of Aquasonic 100 Ultrasound Transmission Gel manufactured by Parker Laboratories INC Fairfield New Jersey 07004 Recommended ultrasound probe sterile sheaths Where fluid contamination is possible cover the ultrasound probe with an appropriate sterile sheath this ...

Page 41: ...atient is positioned appropriately Default settings Press the Power button to power up the System Adjustable settings cannot increase acoustic output ensuring the device always operates within safe acoustic output levels The Home screen appears when the device is on FIGURE 15 Home screen with up to five tiles FIGURE 15 Home screen Tap Bladder Volume to perform a bladder volume examination This opt...

Page 42: ...tored examinations This option is not available if Local Storage is disabled in Settings Bladder scanning Measuring bladder volume 1 To start a exam from the Home screen tap Bladder Volume 2 Select the appropriate patient type Normal Pediatric Deep or Pregnant Normal BMI less than 30 Deep BMI greater than or equal to 30 or scar tissue present Pediatric Weight under 27 kg Pregnant Active pregnancy ...

Page 43: ...ressure firmly 7 Tilt the probe 15 to 20 degrees so the probe beam points slightly toward the patient s feet 8 Tap the Scan button to start the measurement If the probe is incorrectly positioned the display will prompt you to angle the probe FIGURE 18 Transducer positioning FIGURE 18 Transducer positioning When the bladder has been found an orange outline will appear around the bladder The pubic b...

Page 44: ... probe Do not fan too fast or too slow As a guideline a complete fan should take around 3 5 seconds Do not twist the probe Angle the probe so that the bladder is in the middle of the ultrasound image During acquisition the display will show the fan position When the three dimensional data acquisition is complete the System automatically completes the scan and displays the measured volume see FIGUR...

Page 45: ...justed if required If a bladder has been outlined where no bladder is present then drag the progress marker to the end of the bladder tap and select Mark Bladder End Tap End Editing to finish Audio feedback The System provides audio feedback during bladder measurement as follows A short double beep sounds when the System has detected a bladder and you can start the fan of the probe A short single ...

Page 46: ...nd three to five seconds If greater than symbol appears along with the volume measurement 1 Center the bladder in the ultrasound image on the screen 2 Fan the probe toward one hip until you hear the sound indicator and see an arrow then fan back toward the other hip until a second sound is heard to capture the entire bladder FIGURE 23 Greater than symbol FIGURE 23 Greater than symbol 3 Anchor the ...

Page 47: ...ing motion see FIGURE 24 Twisting detected FIGURE 24 Twisting detected Make sure that the orientation marker remains pointing toward the patient s head If 0 ml reading When obtaining a measurement of 0 ml tap the icon to display a message indicating possible reasons for an empty result Probe Twisted Correct Position ...

Page 48: ...see FIGURE 25 Bladder found not found FIGURE 25 Bladder found not found Phantom mode The System provides a special patient type for scanning ultrasound phantoms To select the phantom patient type tap and select Enable Phantom Mode Abdominal Ultrasound imaging Tap Ultrasound Imaging on the Home screen see FIGURE 15 Home screen to initiate an ultrasound scan Bladder found Bladder NOT found ...

Page 49: ...re customized ultrasound settings for each clinical application Ultrasound scanning The probe orientation marker corresponds to the Orientation icon on the display FIGURE 27 Probe orientation markers The convention is for the probe orientation marker to be on the patient s right for transverse scans and toward the head for sagittal or coronal scans Tap the Scan icon to start unfreeze and stop free...

Page 50: ... ending saving exams FIGURE 28 Ultrasound scanning Controls for changing gain brightness and depth are provided see FIGURE 28 Ultrasound scanning Tapping the icon increases the gain or depth Tapping the icon decreases the gain or depth Use a two finger pinch to zoom in or out of images Ultrasound measurement Tap the Measurement icon to insert calipers arrows or volume measurements on images Calipe...

Page 51: ...ned on the first image and the transverse measurement is positioned on the second image The first and second images must be orthogonal FIGURE 31 Resulting volume measurements Move the caliper or arrow using the Circular handle to position each end of the caliper in the correct place Square handle in the middle to move the entire caliper around the screen Double arrow handle to rotate the caliper a...

Page 52: ...Movie icon in the bottom left of the image area Tap the Movie icon on the image to show the movie controls Scroll through image frames by dragging the progress marker Tap and to pause and play the movie clip Tap the Save Movie icon to save the currently displayed image frame Tap anywhere on the image to hide the movie controls Vascular access Tap Vascular Access on the Home screen see FIGURE 15 Ho...

Page 53: ...25mm wide see FIGURE 33 Vascular scanning FIGURE 33 Vascular scanning Controls for changing gain brightness and depth are provided see FIGURE 33 Vascular scanning Tapping the symbol increases the gain or depth Tapping the symbol decreases the gain or depth Tapping the symbol shows and hides the transducer center marker The probe center marker corresponds to the blue circles on the display Tapping ...

Page 54: ... the setting before a scan and for only the one scan 1 Tap the icon in the upper right corner 2 Select Enable 4 and 5 CM depth see FIGURE 35 Enable 4 and 5 CM depth FIGURE 35 Enable 4 and 5 CM depth 3 Tap the Scan icon to start the scan To enable the setting during the scan and for only the one scan 1 Tap the Stop icon to freeze the image 2 Tap the icon in the upper right corner 3 Select Enable 4 ...

Page 55: ...Double arrow handle to rotate the caliper around its middle You can insert four measurements per image Tap the image outside the shape to end editing that shape Tap a shape to reselect it for editing The units of measurement are cm Vascular access movies Tap the Movie icon to save up to 16 seconds of the vascular access scan as a movie clip The movie clip is saved with a Movie icon in the bottom l...

Page 56: ...ge area to move to the next image Deleting images Tap the Delete icon to delete the displayed image Ending saving exams Tap Done to end the exam You will be prompted to either Save all images movies in the exam Save selected images movies in the exam Discard all images A Remote storage icon is displayed next to Done when remote storage is enabled You are prompted to enter patient details see Enter...

Page 57: ...ser Guide 51 CHAPTER 4 OtherFunctions Annotations Annotations can be added to individual images 1 Tap the icon to display the Exam menu 2 Select Annotation from the drop down list box FIGURE 37 Annotating FIGURE 37 Annotating ...

Page 58: ...o save a recorded message with an image The voice recording controls are displayed Tap the Microphone button to record Speak clearly into the microphone Tap the Stop button to end recording The length of the recording is displayed Tap the Microphone button again to add to the end of the voice recordings Tap the Play button to play a voice recording Images with linked voice recordings will display ...

Page 59: ... list box FIGURE 39 Exam notes FIGURE 39 Exam notes 3 Use the on screen keyboard to type notes in the text box Entering patient details Patient details are required if data is saved Patients may already be stored in the System or they may need to be entered FIGURE 40 Entering patient details Barcode entry Search for patient Existing Patient tab Patient list New Patient tab ...

Page 60: ... New Patient tab to enter the details for a new patient using the on screen keyboard Now you can enter the family name given name EMR identifier sex and date of birth Printing Tap the Printer icon to print to a network see Network printer setup optional or Bluetooth printer see Bluetooth printer setup optional FIGURE 41 Network printing Network printing uses the Mopria service see www mopria org w...

Page 61: ... of EchoNous Export The subfolder is named using the patient name date and time of the exam PatientName YYYYMMDD_HHMMSS Scan review Scan review is available when local storage is enabled Tap the Scan Review icon on the Home screen to review saved examinations in local storage FIGURE 42 Scan Review The data is arranged under patients with each patient being able to link one or more examinations and...

Page 62: ...the exam to open and review the images Deleting exams and patients To delete an exam or a patient from local storage 1 Tap Scan Review on the Home screen 2 Tap and hold the exam or patient The exam or patient will be checked and check boxes appear next to other patients and exams see FIGURE 44 Deleting Patients FIGURE 44 Deleting Patients Tablet Storage Patient A Patient B Patient C Exam 1 Exam 2 ...

Page 63: ...the pin or password All data saved on the System is encrypted Where the System has been stolen no data will be accessible without the PIN or password Secure Wi Fi protocols are supported enabling data to be securely saved to remote storage with no local storage of patient data No Internet ports are open In the event a third party is able to access the System they will not be able to access any dat...

Page 64: ...Other Functions 58 EchoNous Bladder Vein User Guide INTENTIONALLY LEFT BLANK ...

Page 65: ...t If you plan to dispose of the System recycle electrical equipment and batteries where possible and abide by local disposal guidelines and directives If the System is dropped or suffers a heavy knock Inspect the device If you discover major damage do not use the device report the fault to your EchoNous distributor for repair Switch on and check normal function of all controls Tap Menu Settings Ma...

Page 66: ...us Vein and EchoNous Bladder probes by following the appropriate instructions Always use protective eyewear and gloves when cleaning and disinfecting any equipment Before disinfection clean the probe by following the appropriate instructions to remove all gels fluids and particulates that may interfere with the disinfection process Do not submerge the probe display unit or power supply charger as ...

Page 67: ...ved wipe from Table 5 1Presaturated wipes for EchoNous probes 4 Obtain a new wipe Remove any particulate matter gel or fluids that remain on the probe using a new presaturated wipe from Table 5 1Presaturated wipes for EchoNous probes If necessary clean the probe with additional wipes to remove all visible contaminants Disinfection EchoNous Vein and EchoNous Bladder probes intermediate level disinf...

Page 68: ...and leave it on for the disinfectant manufacturer s recommended contact time 3 Remove any residue with a soft cloth moistened with water Do not allow any solutions to dry on the probe and transducer Table 5 1 Presaturated wipes for EchoNous probes Product Company Active Ingredient s Contact Condition Sani Cloth Plus PDI Inc n Alkyl 68 C12 32 C14 dimethyl ethylbenzyl ammonium chlorides 0 125 n Alky...

Page 69: ...ries are not recharging despite the system being connected to a power supply charger Battery temperature exceeds 45ºC Allow device to cool for 10 15 minutes then try charging the battery again The System becomes non responsive or will not power up after recharge Unknown system error Shut down the display and reboot Any error message not resolved by the actions above or the action suggested on scre...

Page 70: ...rasound image Apply moderate downward pressure On large patients apply firm downward pressure Fan the probe at a smooth speed aiming to complete the measurement in less than five seconds Pivot and do not slip or slide the tip of the probe EchoNous customer support If problems persist or recur contact EchoNous Customer Support or your EchoNous distributor For other countries refer to EchoNous websi...

Page 71: ...printer Wireless barcode scanner EchoNous Power Supply P003198 EchoNous Stand Power Supply P004016 EchoNous Type C Power Supply P005179 EchoNous AI Station Stand P005149 MODO Stand P004013 EchoNous AI Station II Stand P006259 EchoNous AI Station Stand Power Supply P005332 EchoNous AI Station Stand Lower Bucket Assembly P005181 EchoNous Carrying Case P005900 ...

Page 72: ... display on the EchoNous AI Station or MODO Stand is configuring a medical electrical system Only use the EchoNous AI Station or MODO Stand accessory P006259 P004013 or P005149 Only connect accessories or items that are specified as being compatible with the EchoNous System Contact EchoNous customer support or your EchoNous distributor for information on compatible accessories and systems Connecti...

Page 73: ... chargers EchoNous stand setup Three optional EchoNous AI Station stands are available MODO Stand P004013 EchoNous AI Station P005149 EchoNous AI Station 2 P006259 Recharge the System only with the power supplies chargers provided The EchoNous power supplies are dedicated units to be used exclusively only with the EchoNous System Do not open or modify the EchoNous Power Supply P003198 or any other...

Page 74: ...tified by EchoNous as part of a medical electrical system to EN IEC 60601 1 Edition 3 1 Do not connect the EchoNous System display to external computers or peripherals using the USB port unless the System is outside the patient area Failure to comply with these guidelines may result in electric shock Only connect accessories or items that are specified as being compatible with the EchoNous System ...

Page 75: ...place TABLE 1 Safe working loads and installation heights of all components Component MountingHeightRange measured from top of central column Safe Working Load Tablet holder 0 11 bottom of range limited by safety stop 0 cm 28 cm As configured no storage Handle bar assembly 13 23 top of range limited by safety stop 33 cm 58 cm 3 lbs on each side 6 lbs total 1 3 kg on each side 2 6 kg total Lower bi...

Page 76: ...ing up AI Station 2 please reference the EchoNous AI Station 2 User Guide P006275 001 Rev A EchoNous AI Station power management Charging The EchoNous AI Stations can be fully charged using the AI Station stand power cord To charge the system first ensure that the tablet display is turned on then connect the power cord to an AC source Sleep mode In order to conserve The battery the AI Station hub ...

Page 77: ...an cloth Disinfection Where bodily fluid or other contamination is expected the EchoNous stands can be disinfected using the spray and wipe method with a variety of disinfection products Follow the manufacturers recommended method The following disinfecting means can be used with the MODO Stand Sani Cloth Active by PDI of Flint UK Tuffie 5 Wipes by VernaCare of Lancashire UK Protex Disinfectant Wi...

Page 78: ...Connectivity and Accessories 72 EchoNous Bladder Vein User Guide INTENTIONALLY LEFT BLANK ...

Page 79: ...xmm 0 827 inches 50g 1 76 oz TABLE 2 Cable dimensions Component Length EchoNous Vein USB micro to USB C 813mm 32 inches Connecting cable tablet display 1800mm 70 9 inches TABLE 3 Display dimensions Component Height Width Depth Weight Samsung S7 tablet 254 mm 9 99 inches 165 mm 6 51 inches 6 4 mm 0 25 inches 498 g 1 2 lbs Samsung S6 tablet 245mm 9 63 inches 160mm 6 28 inches 5 5mm 0 22 inches 420g ...

Page 80: ...mer type For the Samsung S6 tablet display the battery is a 7040 mAh Li ion type TABLE 4 Operating charging transport and storage condition ranges Operating Transport and Storage Temperature C 5 41 F 40 C 104 F 20 4 F 50 C 122 F Relative humidity non condensing 15 90 10 93 Pressure 70 101 5 kPa 10 3 14 7 psi 50 101 5 kPa 7 3 14 7 psi TABLE 5 Charging condition ranges Charging Temperature C 5 41 F ...

Page 81: ...erpretation by a clinician They do not account for variations in acoustic speed of the body which can vary significantly 1 When used as per instructions scanning a bladder in a tissue equivalent phantom TABLE 6 Measurement accuracy Measurement Units Range Accuracy Modes Distance Axial bladder cm Full scale 5 or 0 1cm B mode Lateral bladder cm Full scale 5 or 0 3cm B mode Axial vein cm Full Scale 5...

Page 82: ...s of water The EchoNous Bladder probe and cable assembly is IPX4 The probe is IPX7 from the probe face to the level of cable strain relief See FIGURE 47 Water protection for EchoNous Bladder probe FIGURE 47 Water protection for EchoNous Bladder probe IPX7 from the probe face to this line ...

Page 83: ... water The EchoNous Vein probe and cable assembly is IPX4 The probe is IPX7 from the probe face to the level of cable strain relief vSee FIGURE 48 Water protection for EchoNous Vein probe FIGURE 48 Water protection for EchoNous Vein probe IPX7 from the probe face to this line ...

Page 84: ...Specifications 78 EchoNous Bladder Vein User Guide INTENTIONALLY LEFT BLANK ...

Page 85: ...eries and the System should be disposed of in an environmentally responsible manner in compliance with federal and local regulations It is recommended that you take the System to a recycling center which specializes in the recycling and disposal of electronic equipment The AI Station HUB contains a lithium metal battery and should be disposed of in an environmentally responsible manner in complian...

Page 86: ... distributor for information on compatible accessories and systems Connecting electrical equipment to an MSO effectively leads to creating a medical electrical system and can result in a reduced level of safety MSOs provided with the medical electrical system if provided with the medical electrical system are to be used only for supplying power to the tablet display and optional printer in non ope...

Page 87: ...r degradation of the ultrasound image If the System is found to cause or respond to interference try re orienting the System or the affected device or increasing the separation distance between the devices Contact EchoNous customer support or your EchoNous distributor for further information The System contains sensitive components and circuits Failure to observe proper static control procedures m...

Page 88: ...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 in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 d...

Page 89: ...d from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 Radiated RF IEC 61000 4 3 3 V m 80MHz 2 5 GHz 3 V m d 1 2 80MHz to 800MHz d 2 3 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separations distance in meters m Field strengths from fixe...

Page 90: ...mmunications equipment and the EchoNous System The System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the System as recommended below according to the ma...

Page 91: ...ating and cavitation are not known Given potential does exist for bio effects with ultrasound exposure any exposure should be kept As Low As Reasonably Achievable Scans should only be performed when there is a medical benefit and in the shortest time commensurate with obtaining an adequate study As the acoustic output of the device does not exceed an MI or TI of 1 0 visual display of MI and TI val...

Page 92: ...ertainties are the cumulative effect of measurement uncertainties EchoNousVein Probe fundamental Output 0 961 TIS 0 0088 0 411 69 2 EchoNousVein Probe fundamental Uncertainties 10 3 10 5 5 2 10 5 EchoNousVein Probe THI Output 4 27 TIS 0 0271 0 67 102 29 EchoNousVein Probe THI Uncertainties 10 5 10 6 5 3 10 4 TABLE 4 B mode acoustic output and uncertainties Continued ISPTA 3 mW cm2 TI type TI Value...

Page 93: ...ap and select Settings Select Administration Under Security tap Enable Administrator Password Enter an administrator password Ensure you record the password in a secure location and do not forget or lose it As soon as an administrator password is set up preferences and settings can only be changed by the administrator Software updates restrictions From the Home Screen tap and select Settings Selec...

Page 94: ...ide 4 Enter a Username Family Last name Given First name and if required set the password see FIGURE 1 Add User FIGURE 1 Add User 5 Tap Save to finish You will need to enter a username and password to save patient data see FIGURE 2 User Login FIGURE 2 User Login ...

Page 95: ... the tablet or handheld display to a host computer for example by connecting the tablet to a computer by a USB cable and copying the file from the tablet to the computer On each of the other systems to be set up import the settings 1 Turn the display on and follow the initial setup instructions see Setting up the system 2 Copy the XML file from the host computer to the display local storage 3 From...

Page 96: ...g printing and exporting ultrasound imaging vascular access and or bladder data To restrict ultrasound imaging and vascular access data recording 1 From the Home Screen tap and select Settings 2 Select Administration then select Imaging Data under Recording 3 Select Do not allow recording to restrict recording imaging data To restrict bladder volume data recording 1 From the Home Screen tap and se...

Page 97: ...formance Collateral Standard Electromagnetic compatibility disturbances requirements and tests IEC 60601 2 37 2015 Edition 2 1 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment IEC 60950 1 2005 Information Technology Equipment Safety Part 1 General Requirements EN ISO 10993 1 2009 Biological Evaluation of medical device...

Page 98: ...m A unique interaction between a clinician and patient Up to 50 images may be saved to each exam Exams are identified by patient name and or by date and time of scan MSO Multiple socket outlet Patient A single person with unique details such as name gender date of birth and EMR Id electronic medical record ...

Page 99: ...l safety See safety C calipers See also Measurement cavitation 85 classifications 8 clinical troubleshooting 63 connecting cable 74 contact information 19 64 contraindications See safety Customer Support 64 D depths of 4 and 5 CMs 48 dimensions 73 Display specifications 2 disposal 79 distance see Measurement E exams 92 external materials 79 I Image Annotations voice 52 Intended uses 3 IPX Rating 7...

Page 100: ...ironment 9 patients 92 Power button 24 50 sources 66 R recommended gel 34 recording 52 references 91 S safety 79 biological 85 contraindications 3 13 service See maintenance setup 24 shutdown 50 solvents 12 sterile sheaths 34 support 64 T touch screen navigating 24 trademarks 20 training 7 turn off 50 turn on 24 U ultrasound gel 34 risks 85 User Manual 1 conventions 1 version 1 2 ...

Page 101: ...EchoNous Bladder Vein User Guide 95 V version User Manual See User Manual W warnings 10 Z Zooming 44 47 ...

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