MobileODT EVA 3 Plus Application guide

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
[email protected]
Tel.: [phone]
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
In 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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EVA 3 Plus: Device User Manual
fluid.
4. Do not use strong detergents or alcohol under any circumstances for
optics cleaning. This would lead to irrevocable damage to the
optically-coated lens surfaces.
5. To limit contamination, use recommended disinfectant agents between
each exam.
6. Do not use corrosive materials or strong cleaning materials other than
those specifically prescribed on the casings or on the optics. Such
materials lead to permanent damage of the painted surface of your
colposcope and/or scratch the lens coatings of the optics. This leads to
considerable loss of quality of the entire visual system.
7. The EVA System was built to be resilient, but needs to be taken care
of like any other electronic device. It should never 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.
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 battery to full capacity before continuing use.
9. No modification of this equipment is recommended.
1.9. Product Overview
Before use of your colposcope, check for damage on the outside of the
transport packaging, the optical unit, mobile device, and any accessories.
The following chapters provide step-by-step instructions for the testing,
installation, operation, and security references.
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EVA 3 Plus: Device User Manual
1.10. Components
Before initial setup of the EVA System, check that you have received all the
following components:
1. Optical unit body and lens
2. Samsung J530 mobile device*
3. Syncwire 2 Ports 30W/6A Dual Port MicroUSB Charger Spare parts kit
including: 1 charging cable, 2 technician screws and an Allen key
4. Neck strap
5. Lens cleaning cloth
6. User guide
If any parts are missing, please notify MobileODT.
* Please refer to the Samsung J530 user manual to find specifications
regarding the WiFi, how the mobile device should be configured and operated
including the quality of service, operating distances and ranges, security
requirements, and how to deal with any risks and problems that may arise.
To avoid doubt, the primary function of the EVA System 3 Plus is for mobile
colposcopy, the magnified viewing of the tissues of the vagina, cervix, and
external genitalia for the purpose of conducting 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 connection is
restored.
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EVA 3 Plus: Device User Manual
2. Get to know the EVA System 3 Plus
Back View (figure 1)
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EVA 3 Plus: Device User Manual
Front View (figure 2)
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EVA 3 Plus: Device User Manual
Left View (figure 3) Right view (figure 4)
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EVA 3 Plus: Device User Manual
2.1 Connecting to the EVA stand or a neck strap
Together with your EVA System, MobileODT provides a device stand for
stabilizing the colposcope while capturing an image. There are two types of
stands: a wheeled stand and a portable stand. Below are basic instructions on
connecting the colposcope to both models. See the detailed assembly
instructions that came with the stand itself for further explanations.
2.1.1. Wheeled Stand
The wheeled stand 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. During the exam, the stand wheels should be locked manually to
improve stability and limit motion blur. In addition, the 360° ball head can
be adjusted during the example to improve the ability to visualize the
cervix at the necessary angle.
2.1.2. Portable Stand
The portable stand also enables a hands-free examination. This stand can be
carried from location to location, can be folded for portability between exam
rooms, or put into the 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:
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EVA 3 Plus: Device User Manual
a. To attach the strap to the device, first flatten the strap and slide it
under one corner of the strap attachment slot.
(figure 5) (figure 6)
b. Slide the strap under the second corner and pull through.
(figure 7) (figure 8)
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EVA 3 Plus: Device User Manual
2.2. Turning on the LED light
Turn on the LED light by pressing the on/off button.
(figure 9) (figure 10)
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EVA 3 Plus: Device User Manual
3. How to Capture a Clinically Useful Image
Clinically useful images are critical for remote consultation, patient
documentation, and quality assurance purposes. There are several factors to
consider to ensure high quality images.
3.1. Stability
The colposcope should be in a stable position while capturing an image. The
unit can be stabilized by:
a. Using a stand: The colposcope can be attached to a provided stand.
The height of the stand should be the same as the height of the
examination table (standard medical table height is 80-110
cm/31.5-43.5 inch).
b. Using the neck strap: if you need to take the colposcope off the
stand, please be sure 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.
c. 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 visualization
screen in order to capture an image.
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EVA 3 Plus: Device User Manual
3.2 Positioning
a. Distance: The device should be positioned at a distance of 25-40 cm /
10-15.7 inches from the patient’s cervix.
Important: the colposcope should never come into physical contact with the
patient.
b. Angle: The entire face of the cervix should be captured in the image,
without any obstruction by the speculum. The colposcope lens should be
aimed directly at the patient's cervix.
(figure 11)
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