MobileODT EVA System

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EVASystemUserManual

No.10LB038

Rev.04

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Page3of86

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EVA(EnhancedVisualAssessment)System

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UserManual

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Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe

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Table of Contents4
Hardware8
General9
Indications for Use10
Contraindications10
Risks and Benefits10
How to Read These Operating Instructions10
Symbols and Markings10
Important Notes on Safety11
List of Warnings11
List of Precautions12
Product Overview12
Components12
Primary Function13
EVA System Device14
Connecting to the EVA Stand or a Neck Strap16
Turning on the LED Light19
Charging20
Charging the Optical Unit20
Charging the Mobile Device21
Taking the Mobile Device out of the Optical Unit22
To Remove the Mobile Device from the Optical Unit (Figure 17)22
To Insert the Mobile Device into the Optical Unit (Figure 18)22
OPTIONAL: to Secure the Phone into the EVA System Device, Preventing Users from Removing the Phone from the Optical Device (Figure 19)22
Care and Maintenance24
Storage24
Lens Care24
Body/Base24
Cleaning Instructions24
Troubleshooting & Support25
Mobile Unit Troubleshooting25
Lens Troubleshooting25
Mobile Device Troubleshooting26
EVA Application Troubleshooting26
How to Capture a Clinically Useful Image27
Stability27
Positioning27
Illumination28
Focus28
Specifications30
Electromagnetic Compatibility Manufacturer Declaration31
Electromagnetic Emissions31
Recommended Separation Distances33
Replacement Parts and Technical Service35
Software35
EVA Portal36
Welcome Screen36
Setting up a User36
Forgot Password38
Viewing Patient Records39
Searching for Patient Records40
Reviewing and Editing Patient Examination Records40
Editing the Exam40
Viewing Images and Annotations41
Adding Notes43
Help43
Export & Download44
EVA System Software Application47
Setting up a New User47
Log in (Existing User)50
Reset PIN51
Changing the User51
Reset EVA Account Password52
Optout Status53
Notification Center54
Performing an Exam55
Capture Images57
Changing Settings During an Exam (Camera Menu)59
Review Media Files60
Add Annotations60
Summary62
Exporting the Exam62
Back up Exams on a Local Drive64
Limited Storage Preventing Export65
Reviewing Exams on the App65
Deleting an Exam68
Exam Drafts69
About69
Handwave Feature70
Camera Mode70
Quality Frame70
Support71
Learn71
Log out71
Appendices72
Appendix 1: EVA COLPO73
Add History of Present Illness73
Colposcopic Impression73
Optional Features74
Appendix 2: EVA SANE75
Add Additional Details75
Add Clinical Impression75
Additional Features76
Appendix 3: EVA VIA78
Add Additional Details78
Add Clinical Impression79
Optional Features79
Appendix 4: Visualcheck79
Intended Use80
Target Population80
Warnings and Precautions80
Performing Visualcheck Assessment81
Running the Visualcheck Analysis from the EVA Device81
Running Visualcheck Analysis from the EVA Portal82
Visualcheck Results83
Appendix 5: Quality Frame85
Using the Quality Frame85

MobileODT EVA System - Page 3

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