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MobileODT EVA System Скачать руководство пользователя страница 1

EVA

System

User

Manual

No.

10

LB

038

Rev.04

Page

1

of

86

EVA

System

User

Manual

Revision

History

Rev.

no.

ECO/

CAPA/

SWC

Change

Description

Date

01

CAPA

20005

ECO

334,

ECO

335,

SWC

336

Unify

the

following

user

manuals

into

one

document:

AUM

001

(Becomes

obsolete),

PUM

001

(Becomes

obsolete),

10

LB

004

(becomes

controlled

reference

document).

Update

to

features

according

to

ECO’s/SWC’s.

Add

VisualCheck

26/Nov/2020

02

NA

Update

User

Guide

Name,

rephrase

section

1

intro

(General)

10/Jan/2021

03

Following

sections

were

updated:

Update

VisualCheck

flow

–

section

15.5

Handwave

settings

screenshots

Section

11.21

“About”

section

(replaced

“Settings”)

–

Sections

11.20,

11.4.6,

11.7.4

High

contrast

filter

on

portal

Section

10.9.10

Search

bar

on

app

–

Sections

11.19

Quality

frame

screenshot

Section

11.25

24/Jan/2021

04

SWC

338

Add

SANE

Bluetooth

foot

pedal

section

13.3.3

Limited

capture

images

for

demo

account

–

section

11.9.11

Limitation

of

active

logins

11.4,

10.6

reCaptcha

section

10.5

,

11.3

22/Feb/2021

05

SWC

339+3

40

6

digit

PIN

code

policy

–

Updated

sections

and

screenshots

11.1.8,

11.1.10,

11.5,

11.6.1

Re

enter

password

screenshot

10.4

Change

sign

in

screens

–

11.7.3,

11.1.5,

11.1..6

Updated

screenshot

–

10.8.1

Change

“Sign

in”

to

“Log

in”

+

screenshots

–

11.2,

11.7.1,

10.1,

10.3
Added

message

on

sign

in

screens

–

updated

screenshots

11.7.3

Stronger

password

policy

–

11.7.4,

10.2.8,

10.4.4

22/Apr/2021

Rolling

Stand

Updated

section

2.1.1.5

08/Aug/2021

Hardware

section

Figures

numbering

organizing

–

sections

2.1.3,

2.2,

3.1,

4.1,

4.2,

4.3,

7.2.2,

7.3.2,

7.4.2

13/Oct/2021

Approval

Matrix

Name

Position

Signature

Date

Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe

1
2
3
...
»

Содержание EVA System

Страница 1: ...h bar on app Sections 11 19 Quality frame screenshot Section 11 25 24 Jan 2021 04 SWC 338 Add SANE Bluetooth foot pedal section 13 3 3 Limited capture images for demo account section 11 9 11 Limitation of active logins 11 4 10 6 reCaptcha section 10 5 11 3 22 Feb 2021 05 SWC 339 3 40 6 digit PIN code policy Updated sections and screenshots 11 1 8 11 1 10 11 5 11 6 1 Re enter password screenshot 10...

Страница 2: ...of 86 Written by Almog Avivi Product Manager 13 Oct 2021 Reviewed by Yana Katsman QA RA Manager 13 Oct 2021 Reviewed by Lior Shwarzwald Head of Product 13 Oct 2021 Approved by Leon Boston CEO 13 Oct 2021 Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 3: ...EVA System User Manual No 10 LB 038 Rev 04 Page 3 of 86 EVA Enhanced Visual Assessment System User Manual Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 4: ...Unit 20 3 2 Charging the Mobile Device 21 4 Taking the Mobile Device out of the Optical Unit 22 4 1 To remove the mobile device from the optical unit figure 17 22 4 2 To insert the mobile device into the optical unit figure 18 22 4 3 OPTIONAL To secure the phone into the EVA System device preventing users from removing the phone from the optical device figure 19 22 5 Care and Maintenance 24 5 1 St...

Страница 5: ...6 Searching for patient records 40 10 7 Reviewing and editing patient examination records 40 10 8 Editing the Exam 40 10 9 Viewing images and annotations 41 10 10 Adding notes 43 10 11 Help 43 10 12 Export Download 44 11 EVA System software application 47 11 1 Setting Up a New User 47 11 2 Log in existing user 50 11 3 Reset PIN 50 11 4 Changing the user 51 11 5 Reset EVA account password 52 11 6 O...

Страница 6: ...c impression 73 12 3 Optional features 74 13 Appendix 2 EVA SANE 75 13 1 Add additional details 75 13 2 Add clinical impression 75 13 3 Additional features 76 14 Appendix 3 EVA VIA 78 14 1 Add additional details 78 14 2 Add clinical impression 79 14 3 Optional features 79 15 Appendix 4 VisualCheck 80 15 1 Intended use 80 15 2 Target population 80 15 3 Warnings and Precautions 80 15 4 Performing Vi...

Страница 7: ...al No 10 LB 038 Rev 04 Page 7 of 86 17 Appendix 6 Teleconsultation Zoom Telehealth 86 17 1 Installing the Zoom Application 86 17 2 Initiating a teleconsultation connection 86 Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 8: ...EVA System User Manual No 10 LB 038 Rev 04 Page 8 of 86 Hardware Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 9: ... and VIA and on all of our device models including EVA 3 Plus EVA WELL and EVA 3 0 For those users on EVA 3 0 please contact support for additional information on hardware maintenance and support For further support please contact us MobileODT LTD Ben Avigdor 8 Tel Aviv Israel 6721832 Email support mobileodt com Tel 1 617 454 4687 Website www mobileodt com The following is the contact information ...

Страница 10: ...ons These instructions are structured around the operation of the EVA System from assembly to clinical use Basic troubleshooting information is also provided The following content contains instructions for the assembly and use of the EVA System colposcope Instructions for the integrated mobile application and cloud connected online portal are referenced in the manual 1 5 Symbols and Markings Gener...

Страница 11: ...re are no user serviceable parts in this unit or in its accessories other than the mobile device Any attempt to disassemble and or repair this unit will result in voiding of the warranty 1 7 3 Capture images only within the EVA application 1 7 4 The attached lens should not be removed from the unit it was sent with without written approval from the manufacturer 1 7 5 The LED light is extremely bri...

Страница 12: ...er be stored or operated in areas where it could get wet or could be exposed to environmental conditions such as extreme temperature or humidity prolonged direct sunlight dust etc 1 8 8 If the LED light ceases to work due to battery drain or LED burn out stop using the colposcope and recharge the batteries Sometimes a discharged battery will manifest via a flickering LED In this case recharge the ...

Страница 13: ...cting colposcopy Use of the colposcope and its primary function of visualization is not dependent upon constant WiFi or mobile connection If interference from other WiFi devices affects the WiFi connection or if the WiFi connection is interrupted or lost due to any other reason the colposcope can still function as intended and images will be synced and accessible on the online portal when a connec...

Страница 14: ...EVA System User Manual No 10 LB 038 Rev 04 Page 14 of 86 2 EVA System device Back View figure 1 Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 15: ...EVA System User Manual No 10 LB 038 Rev 04 Page 15 of 86 Front View figure 2 Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 16: ...d enables hands free examination and allows you to move freely within your clinic while keeping the EVA System connected to the stand at all times 2 1 1 2 The wheeled stand arrives in two distinct parts the base and the pole During the exam the stand wheels should be locked manually to improve stability and limit motion blur 2 1 1 3 In addition the 360 ball head can be adjusted during the example ...

Страница 17: ...re are two stand models that are assembled according to the assembly instructions that are provided with the stand The stand model is provided according to stock available 2 1 1 5 1 A 3 legs stand 2 1 1 5 2 A 4 legs stand Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 18: ...e accompanied carrying case to move between clinical sites 2 1 3 Connecting the Neck Strap The colposcope can be connected to a neck strap for carrying the unit more comfortably around your clinic Please follow the steps below to connect the neck strap to the colposcope securely 2 1 3 1 To attach the strap to the device first flatten the strap and slide it under one corner of the strap attachment ...

Страница 19: ...f 86 figure 5 figure 6 2 1 3 2 Slide the strap under the second corner and pull through figure 7 figure 8 2 2 Turning on the LED light Turn on the LED light by pressing the on off button figure 9 figure 10 Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 20: ...arge the optical unit connect the Micro USB charger to the unit s right side charging port Connect the cable to a wall socket with the proper USB electrical port adapter figure 11 3 1 2 The charger included has two slots for USBs to allow charging in a single electrical outlet 3 1 3 The Charge Indicator Lights can be found above the charging port on the front of the optical unit When connected to ...

Страница 21: ... USB cable to the charging port built in to the unit 3 2 2 To access the port raise the charging port cover located above the LED light on off switch 3 2 3 Connect the cable to a wall socket with the proper USB electrical port adapter 3 2 4 The mobile device should be charged whenever the colposcope is not in use to ensure proper functionality during the examination figure 12 Doc ID 4baaf484d7f5f0...

Страница 22: ... icon at the top of the image capture screen and switch the capture mode setting to camera mode This will allow normal uninverted imaging through the EVA application 4 2 To insert the mobile device into the optical unit figure 13 4 2 1 Place the mobile device back into the optical unit 4 2 2 Push the connectors of the top bracket into the slots of the optical unit and then pull down to fully engag...

Страница 23: ...anual No 10 LB 038 Rev 04 Page 23 of 86 figure 14 To secure the phone into the EVA System device preventing users from removing the phone from the optical device figure 15 Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 24: ...ning the base of the optical unit should only be done with disinfectant towelettes such as CaviWipes or their equivalent 5 4 1 Use 3 5 towelettes at minimum to wipe the optical unit body from the handle both down the internal side facing the user and the external side facing the patient making your way to the top of the unit 5 4 2 This should be done in a scrubbing motion covering both sides of th...

Страница 25: ...ontact customer service 6 1 5 Burned out LED Light If the LED light is burned out and provides no or low illumination the user should check to make sure it is switched on If the battery is charged and the LED light still does not turn on or provides low light contact service 6 1 6 Charge Indicator Lights Upon system initialization the indicator lights flash and should blink when the battery is cha...

Страница 26: ...fer to archive patient cases to the Online Portal If the user does not want to sync information with the EVA Online Portal the user should transfer patient cases to localized storage and then manually delete cases from the EVA Application If the warning persists when there are few or no patient cases the user should contact customer service 6 3 4 Cracked Mobile Device Screen If the mobile device s...

Страница 27: ...re to use the neck strap for stability When holding the unit by hand with a neck strap please confirm that the neck strap is extended completely The length of the neck strap can be adjusted for user comfort 7 1 3 Hand wave feature Images can be captured without touching the screen through the hand wave feature This enables the user to wave their hand in front of the proximity sensor above the visu...

Страница 28: ...hen holding the colposcope make sure not to block the LED light with your finger figure 17 figure 18 7 4 Focus There are two ways to adjust the colposcope focus 7 4 1 The first is to adjust the distance between the colposcope and the patient Once you have achieved adequate focus as you zoom in and out digitally you can use the fine focus wheel at the tip of the lens to re adjust your focus 7 4 2 T...

Страница 29: ...anual No 10 LB 038 Rev 04 Page 29 of 86 figure 19 After you have captured images it is important to review the images to verify they are clinically useful Fine focus wheel Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 30: ...m 400mm 4 0X optical 16X with digital zoom at 225mm 3 8X optical 15X with digital zoom at 425mm 53mm at 225mm 104mm at 400mm 17mm at 225mm 34mm at 425mm Operating Environment Ambient temperature Relative humidity Atmospheric pressure 50 F 10 C to 104 F 40 C 95 max 70kPa 10 1psi to 110kPa 16psi Transportation and Storage Environment Ambient temperature Relative humidity Atmospheric pressure 4 F 20 ...

Страница 31: ...of the unit must ensure that it is used in such an environment Table 1 Guidance and manufacturer s declaration electromagnetic emissions EVA System The EVA System is intended for use in the electromagnetic environment specified below The customer or the user of the EVA System should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emis...

Страница 32: ...nsure it is used in such an environment Immunity test IEC 60601 1 2 Test level Compliance level Electromagnetic environment guidance Radiated RF IEC 61000 4 3 10 V m 80 MHz to 2 5 GHz 10 V m Portable and mobile RF communications equipment should be used no closer to any part of the EVA System including cables then the recommended separation distance calculated from the equation applicable to the f...

Страница 33: ...bnormal performance is observed additional measures may be necessary such as re orienting or relocating the EVA System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 8 3 Recommended separation distances The EVA System is intended for use in an electromagnetic environment in which radiated radio frequency disturbances are controlled The user and or installer ...

Страница 34: ...cy of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Doc ID 4baa...

Страница 35: ...f the EVA System colposcope These can be found on the label located on the back of your unit For further support please contact support mobileodt com MobileODT LTD Ben Avigdor 8 Tel Aviv Israel support mobileodt com 1 617 454 4687 www mobileodt com Entering the portal Enter the EVA Portal by entering the following link in your browser www eva mobileodt com The supported browsers are the latest ver...

Страница 36: ...section 4 Reset your password by pressing Forgot password refer to section 5 Contact MobileODT refer to section 8 Review our terms and conditions as well as our privacy policy 10 2 Setting up a user 10 2 1 If you are new to the EVA System and did not set the password on an EVA device or on the portal click on Set up 10 2 2 Enter the email associated with your EVA user account Doc ID 4baaf484d7f5f0...

Страница 37: ...folders 10 2 7 After entering the activation code you will be requested to select a password 10 2 8 The password requires a minimum of eight characters including a capital letter a lowercase letter one number and one special character This password will be used to access your EVA account both on the portal and on EVA devices 10 3 Logging in 10 3 1 If you have already set up your EVA user and have ...

Страница 38: ...our EVA account 10 4 Forgot password 10 4 1 Click Forgot password on the welcome screen 10 4 2 Enter the email address associated with your EVA account 10 4 3 An email will be sent to the email entered with a temporary password 10 4 4 Enter the temporary password and create a new one then enter it once again Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 39: ...n then proceed to log in as normal 10 6 Limitation of active logins There is a limit of 10 active connections to the EVA System either to multiple EVA devices or to the EVA Portal from multiple locations that can be maintained by one user 10 7 Viewing patient records Upon successful login you can view a list of all the cases you have performed with the EVA System with exam notes 10 7 1 To review a...

Страница 40: ...xamination record all the information collected about the patient during current and past examinations is displayed patient details documentation of the exam images annotations and history of present illness 10 9 2 If multiple examinations of the same patient have been collected they will be shown on the top of the patient examination record The user can choose to view the specific examination by ...

Страница 41: ...ant information appears and the user can change the field To save the changes the user needs to press on Save 10 11 Viewing images and annotations 10 11 1 Viewing images in the patient examination record the user can open a large size version of any image by clicking on the thumbnail of that image Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 42: ...en to navigate through the images 10 11 5 Download image the user can download an image by pressing the download button 10 11 6 Show Hide Annotations By clicking on the annotation button on the top left of the screen users can view or hide any annotations that were made on that particular image Annotation description notes are displayed on the right hand side of the screen Locations of annotations...

Страница 43: ...0 11 10 2 It can be configured on the camera settings menu 10 11 10 3 Whenever it is turned on it can be found on the capture screen instead of the green filter button 10 11 11 To close the large size image the user should press the X button on the top right corner 10 12 Adding notes 10 12 1 The user can enter free notes and view them in the examination record 10 12 2 To enter a new note the user ...

Страница 44: ...The PIN cannot be sequential and an individual digit cannot be repeated more than 3 times 10 14 1 3 After setting the pin the PDF will be sent to the user s email or downloaded to the computer 10 14 1 4 In order to view the exam PDF file the user will need to enter the code he had previously selected Option 1 Export exam to email Upon choosing this option the user will receive a link to his email ...

Страница 45: ...t Add pdf from the settings menu 10 14 2 2 Then either drag and drop or browse the local computer for your selected file and upload to the EVA Portal Click add logo to attach the selected logo to the pdf for export 10 14 2 3 Image files must be no more than 4MB and in jpg or png format 10 14 2 4 Click confirm to have this logo automatically added to any future pdf reports 10 14 3 Download all exam...

Страница 46: ...h Zip file contains a CSV file which lists all the exported data that exists within the Zip file and a folder containing each exam as a separate file PDF report and media files 10 14 3 5 Along with links to the ZIP files you will also receive a link to a CSV file with a summary of all downloaded exams This summary is a content list indicating on which ZIP file each exam exists and if it was downlo...

Страница 47: ...of 86 11 EVA System software application 11 1 Setting Up a New User 11 1 1 Enter the EVA app 11 1 2 Tap on set up 11 1 3 Enter the email address that was used to create your EVA account 11 1 4 Tap on Next Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 48: ...de 11 1 6 Enter the activation code you received in your email and tap on Next An example for such an email 11 1 7 Set a password the password requires a minimum of eight characters including a capital letter a lowercase letter and one number tap on Next This password will allow you to access the EVA System including the EVA portal Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 49: ...he PIN will give you secure access to this particular EVA device tap on Save PIN 11 1 9 Read and accept the terms of use before using the app Click on I Agree 11 1 10 You will be directed to the login page Enter your PIN to enter the application Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 50: ...If If a user has made 5 failed attempts to login then on the sixth attempt they must complete a reCapture form to verify that they are not a robot 11 3 2 Once the reCapture is successful they can then proceed to log in as normal 11 4 Global sign out 11 4 1 There is a limit to the number of active connections to the EVA System either to multiple EVA devices or to the EVA Portal from multiple locati...

Страница 51: ...e You will have 5 attempts to enter the PIN correctly If you do not remember the PIN tap on Forgot PIN and it will redirect you to the sign in screen On this screen you will be able to log in using your email and password 11 6 Changing the user 11 6 1 If the user that is presented on the screen is not your user tap on Change user 11 6 2 The app shows all the users that were added to that particula...

Страница 52: ...in question is only removed from this particular device All the data that this user had created is available through the EVA Portal The user will still be present on any other EVA device that they may have logged into This user can also add his her account to this device again in the future 11 7 Reset EVA account password A User s EVA account password can be reset through initial log in menu 11 7 ...

Страница 53: ...the dedicated field Enter a new password in the dedicated field The password requires a minimum of eight characters including a capital letter a lowercase letter and one number and one special character Re enter the password and Tap on Next 11 8 Opt out status 11 8 1 A user or organization may choose to operate in Opt out status meaning that none of their exam data will be uploaded or synced to th...

Страница 54: ...SB and backed up on a local computer see section 14 for instructions 11 9 Notification Center 11 9 1 Users will be notified through the notification center of important information intended to maintain smooth running of their EVA System such as when a software update is available 11 9 2 Users are alerted that they have unread notifications when they open the EVA device by a red dot appearing on th...

Страница 55: ...wing fields Medical Record Number MRN first name last name date of birth or age if date of birth is unknown and a contact phone number 11 10 2 If a medical record number is entered the subsequent fields can be skipped 11 10 3 If no medical record number was entered first name last name and date of birth will be mandatory Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 56: ...rst and last names with the same date of birth already exists in the user s account the system will ask the user if the new patient they entered is the same patient that already exists 11 10 7 The user can either click Same patient to add the new exam to the existing patient record or click Re enter MRN or Add as new patient if it is not the existing patient 11 10 8 Please contact Customer Support...

Страница 57: ... capturing clinically useful and focused images Ensure the device light source is turned on Ensure the fine focus wheel found at the tip of the lens is turned all the way out Adjust the device at the appropriate working distance from the patient typically between 22 42 cm Adjust the fine focus wheel to achieve optimal focus 11 11 3 Pinch in or out with your fingers on the screen to zoom in and out...

Страница 58: ...p on the stopwatch icon at the top of the screen A countdown of one minute will start After one minute another countdown of four minutes will start It is advisable to take and capture images and biopsies within this 4 mins window of time 11 11 6 Capture images by taping the capture button on the bottom middle of the screen Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 59: ... You can also capture images while recording by pressing the button at the right bottom of the screen 11 11 11 If you are under a demo or distributor account you can take only 3 images and 1 video 11 12 Changing settings during an exam Camera menu The camera s settings can be managed directly during an exam by accessing the camera menu 11 12 1 The camera menu can be opened by clicking the settings...

Страница 60: ...were taken from first to last 11 13 2 Swipe with your finger to the left to see the next file and swipe to the right to see the previous file 11 14 Add annotations 11 14 1 To annotate an image tap the location on the image you would like to annotate and follow the suggested options to record the relevant details Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 61: ...tap on the annotation and tap on edit following the suggested options to edit the relevant details 11 14 3 To delete an annotation tap on the annotation and tap on delete A warning confirming that you want to delete that annotation is shown Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 62: ...A Portal The exam will be available for further editing on the device for the next 24 hours 11 16 Exporting the exam 11 16 1 After tapping on Finish exam an option to export the exam is available The user can choose between exporting to an email or to a folder on the device from which the exams can be exported and backed up manually on a local drive 11 16 2 Tap on the button Export exam 11 16 3 A ...

Страница 63: ...the examination report as a PDF When the upload process to the portal is completed the exam will be sent to the user s email 11 16 6 Upon choosing Export to folder the system will start exporting the examination report and media as a ZIP When the zip is created the exam will appear on the Exams for export page 11 16 7 If you don t want to export the exam tap on Done and the home screen will be dis...

Страница 64: ...xport page can be reached from the main menu and presents a list of all exams that exist on the device as ZIP files that are ready to be exported manually and backed up 11 17 2 The Instructions for export explain what should be done in order to export the exams from the device using a USB cable 11 17 3 In order to clear this list which will clear up space in the external folder of the device the u...

Страница 65: ... the user to return to either the Exams for export or Exam lists and delete exams 11 18 2 It is advisable to remove exams in ZIP format from the device after they have been manually exported via USB to a local computer to ensure that there is free space on the EVA device 11 19 Reviewing exams on the app 11 19 1 To view examinations from the past 24 hours or to see the process of uploading examinat...

Страница 66: ...4 A USB symbol next to exam in any state indicates that an exam has been exported to the ZIP folder and ready to be exported manually via USB connection 11 19 5 To view any exam on the device click on any of them and the system will redirect to edit the exam 11 19 6 Search bar is available on top of the exam list Exams can be searched by patient s Name Last name or MRN 11 19 7 No sync icon will be...

Страница 67: ...e to ensure that exams have been backed up either by manually or by syncing to the EVA Portal before deleting from the EVA Device Only exams that have been completed can be selected for export to ZIP Exported exams can be reached via the main menu under Exams for export see section 14 11 19 9 In the Uploaded tab the examinations that finished uploading are displayed for 24 hours Afterward the exam...

Страница 68: ...online EVA Portal where they are stored permanently unless deleted from the Portal exported as a ZIP file to the device Export internal storage for manual export via USB were a draft exam that was never completed 11 20 3 If any exams that do not fit these criteria were selected for deletion then a popup message will alert users to remove those exams from the deletion list 11 20 4 A confirmation po...

Страница 69: ...fter entering all the patient details The exams are saved as draft and are not synced until the exam is finished 11 21 2 To access all the drafts see the Exams list via the main menu 11 22 About 11 22 1 To access About section tap on the menu icon the top left icon the home screen Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 70: ... of the device above the screen This feature is configurable from the camera setting menu 11 24 Camera mode 11 24 1 In Colposcope mode the camera allows capturing images utilizing the magnification provided by the EVA System lens up to 16x magnification 11 24 2 In Camera mode Users can capture full body or wide angle images This disables the standard colposcope magnification provided by the EVA Sy...

Страница 71: ...th the MobileODT support team for further assistance 11 27 Learn 11 27 1 To access the further training resources tap on the menu icon the top left of the screen 11 27 2 In the menu section tap on Learn The learn button opens up MobileODT s knowledge center which contains more articles and videos 11 28 Log out 11 28 1 To log out tap on the menu icon the top left of the home screen 11 28 2 Tap on t...

Страница 72: ...EVA System User Manual No 10 LB 038 Rev 04 Page 72 of 86 Appendices Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 73: ...of present illness 12 1 2 You can enter the following information HPV status Date of last Pap HPV test Pap result Previous cervical biopsy taken Previous cervical biopsy details Previous cervical ablative or surgical procedure Previous cervical ablative or surgical procedure details None of the fields are mandatory 12 2 Colposcopic impression 12 2 1 Once you have completed the image capture you wi...

Страница 74: ...ion Notes this field allows you to record free notes 12 3 Optional features 12 3 1 For users in some markets depending on regulatory approval the following extra features may be available VisualCheck Quality Frame Zoom Telehealth Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 75: ...turing images 13 1 2 Optional fields include SANE examiner Time of patient arrival Day of Patient arrival Time of call to SANE Day of call to SANE Time of SANE arrival Day of SANE arrival Date of assault Time of assault Location of assault Patient was admitted y N Admission notes Advocate called Y N Advocate name 13 2 Add clinical impression 13 2 1 After images have been captured the users have th...

Страница 76: ...ter A high contrast filter that highlights areas of vascularity and bruising is available for EVA SANE users It can be found on the capture screen next to the green filter button 13 3 3 Optional features Depending on market and regulatory status the following optional features are available for EVA SANE users 13 3 3 1 Zoom Telehealth 13 3 3 2 Bluetooth Foot Pedal SANE users can use a Bluetooth foo...

Страница 77: ...tooth is connected a Bluetooth icon will be shown on the camera screen 13 3 3 2 4 In order to capture an image or start stop a video tap the left pedal 13 3 3 2 5 In order to take zoom in tap on the right pedal 13 3 3 2 6 In order to zoom out tap on the right pedal until you get to the max zoom in Then tap again and perform zoom out Every tap is another zoom step Doc ID 4baaf484d7f5f01d2b8e5dc0fed...

Страница 78: ...ional details 14 1 1 Prior to starting image capture users are prompted to enter additional details about the patient and their history of illness 14 1 2 Optional fields include Number of children Number of vaginal deliveries Town Village Date of last Pap Last Pap result HPV result Marital status Currently pregnant Screened in the past 5 years Y N History of hysterectomy Chief complaint Screener N...

Страница 79: ... clinical impression 14 2 2 Optional fields include VIA result Cervicitis present Colposcopic impression Next steps Antibiotics prescribed Notes 14 3 Optional features 14 3 1 Additional features that are available in some markets depending on regulatory approval include VisualCheck Quality Frame Zoom Telehealth Doc ID 4baaf484d7f5f01d2b8e5dc0fedc637256236abe ...

Страница 80: ...opy and or visual inspection of the cervix who performs a visualization of the cervix during a cervical cancer screening procedure 15 2 Target population 15 2 1 The target population of this application is women between the ages of 30 to 49 15 3 Warnings and Precautions 15 3 1 VisualCheck is currently not available in the USA Please see your distributor to know your local availability in other reg...

Страница 81: ... clean from blood mucus or other obstructions 15 4 4 Images must be collected during a cervical evaluation that includes cleaning of the cervix from blood and mucus application of acetic acid 15 5 Running the VisualCheck analysis from the EVA device In order to run VisualCheck analysis on the EVA device the following steps should be done 15 5 1 Conduct a cervical examination as per your standard g...

Страница 82: ...l abnormal incomplete or inconclusive see section 40 3 for details 15 5 10 If images were added deleted or if the result on VisualCheck run was Incomplete Inconclusive you are advised to run VisualCheck again in order to get an updated result 15 6 Running VisualCheck analysis from the EVA Portal To run the VisualCheck analysis from the EVA Portal there are 4 steps 15 6 1 Log into the EVA Portal wh...

Страница 83: ...recent images 15 6 9 If images are added to or removed from the exam record then the previous VisualCheck result will no longer be displayed You will need to rerun the VisualCheck to receive a new assessment 15 6 10 If an incomplete or inconclusive result is returned then it is possible to repeat the exam once the issues impeding the process are resolved 15 7 VisualCheck results One of four possib...

Страница 84: ...he patient could have moved there is too much mucus or blood or the cervix itself was not suitable for the VisualCheck exam e g a type 3 cervix It is recommended to repeat the test or perform an alternate form of screening 15 7 4 Incomplete The results incomplete indicates that VisualCheck was not able to complete the assessment for technical reasons The most likely cause of an incomplete result i...

Страница 85: ...ty frame feature guides users to capture high quality cervical images When turned on this feature presents a grey or green frame on the screen of the EVA device during visualization image capture 16 1 2 A green frame indicates that quality a combination of focus image quality and positioning of the cervix in the image is excellent A grey frame indicates usable quality for cervical examination In c...

Страница 86: ...aaS360 application found on the home screen 17 1 6 Choose App Catalog 17 1 7 Click Zoom and install 17 1 8 If you don t see the Zoom Application as an option please email support mobileodt com with your username and device ID 17 2 Initiating a teleconsultation connection Once the Zoom application is installed to share your EVA device screen 17 2 1 Open the Zoom app and Sign Up or Sign In 17 2 2 Cl...

Страница 87: ...sman mobileodt com Lior liorshwarzwald mobileodt com and Leon Boston leonboston mobileodt com from qa mobileodt com IP 84 95 243 78 2021 10 13 15 36 52 UTC 3 Viewed by Lior liorshwarzwald mobileodt com IP 82 166 93 77 2021 10 13 15 37 21 UTC 3 Signed by Lior liorshwarzwald mobileodt com IP 82 166 93 77 2021 10 13 17 04 06 UTC 3 Viewed by Yana yanakatsman mobileodt com IP 82 166 93 77 2021 10 13 17...

Страница 88: ...gned by Leon Boston leonboston mobileodt com IP 82 166 93 77 2021 10 13 19 03 22 UTC 3 Viewed by Almog almogavivi mobileodt com IP 84 95 243 78 2021 10 13 19 03 34 UTC 3 Signed by Almog almogavivi mobileodt com IP 84 95 243 78 The document has been completed 2021 10 13 19 03 34 UTC 3 UM 10 LB 038 Rev 04 Unified User Manual pdf 4baaf484d7f5f01d2b8e5dc0fedc637256236abe YYYY MM DD Completed ...

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