MobileODT EVA 3 Plus Guide d'application
EVA 3 Plus
Enhanced Visual Assessment System
Device User Manual
EVA 3 Plus: Device User Manual
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EVA 3 Plus: Device User Manual
Table of Contents
1. General 6
1.1. Indications for Use 7
1.2. Contraindications 7
1.3. Risks and Benefits 7
1.4. How to Read These Operating Instructions 7
1.5. Symbols and Markings 7
1.6. Important Notes on Safety 9
1.7. List of Warnings 9
1.8. List of Precautions 10
1.9. Product Overview 11
1.10. Components 12
2. Get to know the EVA System 3 Plus 13
2.1 Connecting to the EVA stand or a neck strap 16
2.1.1. Wheeled Stand 16
2.1.2. Portable Stand 16
2.1.3. Connecting the Neck Strap 16
2.2. Turning on the LED light 18
3. How to Capture a Clinically Useful Image 19
3.1. Stability 19
3.2 Positioning 20
3.3. Illumination 21
3.4 Focus 22
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EVA 3 Plus: Device User Manual
4. Charging 23
4.1. Charging the Optical Unit 23
4.2. Charging the Mobile Device 25
5. Taking the Mobile Device out of the Optical Unit 26
6. Care and Maintenance 28
6.1 Storage 28
6.2. Lens Care 28
6.3. Body/Base 28
6.4 Cleaning Instructions 28
7. Troubleshooting & Support 29
7.1. Mobile Unit Troubleshooting 29
7.1.1. Low Battery 29
7.1.2. Battery Disconnection 29
7.1.3. Overheating of Internal Board 29
7.1.4. Defective LED Light 29
7.1.5. Burned out LED Light 30
7.1.6. Charge Indicator Lights 30
7.1.7. Optical Unit Casing 30
7.1.8. On/off Switch 30
7.1.9. USB Connection Ports 30
7.1.10. Charger 30
7.2. Lens Troubleshooting 31
7.2.1. Lens Cracks or Misalignment 31
7.2.2. Dirt on Lens 31
7.3. Mobile Device Troubleshooting 31
7.3.1. Low Battery 31
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EVA 3 Plus: Device User Manual
7.3.2. Overheating 31
7.3.3. Insufficient Memory 31
7.3.4. Cracked Mobile Device Screen 32
7.4. EVA Application Troubleshooting 32
7.4.1. Unresponsive EVA Application 32
7.4.2. Unwanted Deactivation 32
7.4.3. Unresponsive Camera 32
8. Specifications 33
9. Electromagnetic compatibility - manufacturer declaration 35
9.1. Electromagnetic emissions 35
9.2. Recommended separation distances 39
10. Replacement parts and technical service 40
10.1. Technical service 40
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EVA 3 Plus: Device User Manual
1. General
Thank you for purchasing the EVA 3 Plus colposcope by MobileODT. Please
read the instructions contained in this user guide thoroughly before using
your new visualization solution..
For further support, please contact us:
MobileODT, LTD.
Ben Avigdor 8,
Tel Aviv, Israel 6721832
Tel.: +1-(617) 454-4687
Website: www.mobileodt.com
The following is the contact information for the European Authorized
Representative used for this device:
MedNet GmbH Borkstrasse 10
48163 Muenster, Germany www.medneteurope.com
FULL TRAINING FOR USE OF THE EVA SYSTEM
CAN BE FOUND AT:
HTTP://LEARN.MOBILEODT.COM
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EVA 3 Plus: Device User Manual
1.1. Indications for Use
The EVA System is intended to provide magnified viewing of the vagina,
cervix, and external genitalia in order to aid in diagnosing abnormalities and
selecting areas for biopsy. The solution is intended for use in hospitals,
doctors’ offices, and remote and rural clinics.
1.2. Contraindications
There are no contraindications for use of the EVA System.
1.3. Risks and Benefits
The EVA System should not touch the patient. There are minimal risks to the
patient. The system has been tested according to specific medical standards.
1.4. How to Read These Operating Instructions
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
General warning sign
Stand by symbol
Press this button to turn on the LED light. Press the button a second time to
turn it off.
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EVA 3 Plus: Device User Manual
Symbol
Description
Serial Number
Catalog Number
Refer to instruction manual/booklet
Prescription use only
CE Mark
Waste of Electrical and Electronic
Equipment (WEEE) compliance symbol
Manufacturer
Date of Manufacture
Authorized Representative in the
European Union
DC (Battery)
Keep away from sunlight
IPXY
IP (International Protection) code
In the United States, federal law restricts prescription medical devices to be
sold by or on the order of a physician or properly licensed practitioner.
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EVA 3 Plus: Device User Manual
1.6. Important Notes on Safety
Before you begin using the EVA System, please become familiar with the
following safety regulations and keep these in mind while using the device.
Users of the EVA System should be thoroughly trained in the appropriate
medical procedures. All users need to read and understand these instructions
before performing any procedure.
1.7. List of Warnings
The warning statements in this manual describe serious adverse reactions and
potential safety hazards, limitations in use imposed by them, and steps that
should be taken if they do occur.
1. Local and/or other applicable laws may restrict the sale of this device
to, or to the order of, a physician or other appropriately licensed
medical professional. The EVA System may not be used unless you or
your organization meet the requirements and/or obligations under
such laws and you assume full responsibility for any illegal purchase
and/or use of the device. The EVA System should only be used by a
trained and licensed operator, whose accreditation is valid in the
country and/or region in which the procedures are being conducted.
2. All service to the EVA System must be performed by MobileODT or
an authorized repair center. There 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.
3. Capture images only within the EVA application.
4. The attached lens should not be removed from the unit it was sent
with, without written approval from the manufacturer.
5. The LED light is extremely bright and should be the only illumination
used as a light source during an examination. Do not stare directly
into the light when it is in operation.
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EVA 3 Plus: Device User Manual
6. The system, both optical unit and mobile device, should not be used
while being charged. Users are requested to take care to charge the
system before use.
7. Only the dedicated mobile device that comes with this optical unit
and complies with relevant safety standards can be used with the EVA
System.
8. When transmitting data from the EVA application over a WiFi
network, only use a password-protected connection (WPA2, not WPA
or WEP).
9. In environments where mobile devices are restricted, the EVA System
can be used in airplane mode. Wherever mobile devices are
permitted for use, the EVA System can be used in its online-connected
mode.
10. This device contains lithium batteries. A battery replacement by
inadequately trained personnel could result in a hazard (such as
excessive temperatures, fire or explosion), and therefore should be
sent back to MobileODT for service.
11. The EVA System should be charged using a standard micro-USB
charger for mobile device charging. A single or dual port USB charger
may be used, but it is recommended to use the charger provided with
the system for optimal results. Specifically, a 5V DC with a current
capacity of 2A, regardless of the power supply input.
1.8. List of Precautions
Precautions in this manual regard the special care exercised by the
practitioner for the safe and effective use of the colposcope.
1. Do not allow the colposcope to come in contact with the patient.
2. Do not touch the optical lense or LED light except as described in the
maintenance section of this manual.
3. Do not immerse any part of the colposcope in cleaning solutions or any
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