MobileODT EVA 3 Plus Device User Manual
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MobileODT EVA 3 Plus Device User Manual

Enhanced visual assessment system
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EVA 3 Plus
Enhanced Visual Assessment System
Device User Manual

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Summary of Contents for MobileODT EVA 3 Plus

  • Page 1 EVA 3 Plus Enhanced Visual Assessment System Device User Manual...
  • Page 2 EVA 3 Plus: Device User Manual...

  • Page 3: Table Of Contents

    EVA 3 Plus: Device User Manual Table of Contents 1. General 1.1. Indications for Use 1.2. Contraindications 1.3. Risks and Benefits 1.4. How to Read These Operating Instructions 1.5. Symbols and Markings 1.6. Important Notes on Safety 1.7. List of Warnings 1.8.
  • Page 4 EVA 3 Plus: Device User Manual 4. Charging 4.1. Charging the Optical Unit 4.2. Charging the Mobile Device 5. Taking the Mobile Device out of the Optical Unit 6. Care and Maintenance 6.1 Storage 6.2. Lens Care 6.3. Body/Base 6.4 Cleaning Instructions 7.
  • Page 5 EVA 3 Plus: Device User Manual 7.3.2. Overheating 7.3.3. Insufficient Memory 7.3.4. Cracked Mobile Device Screen 7.4. EVA Application Troubleshooting 7.4.1. Unresponsive EVA Application 7.4.2. Unwanted Deactivation 7.4.3. Unresponsive Camera 8. Specifications 9. Electromagnetic compatibility - manufacturer declaration 9.1. Electromagnetic emissions 9.2.

  • Page 6: General

    EVA 3 Plus: Device User Manual 1. General Thank you for purchasing the ​ E VA 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.

  • Page 7: Indications For Use

    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’...
  • Page 8 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...

  • Page 9: Important Notes On Safety

    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).

  • Page 10: List Of Precautions

    EVA 3 Plus: Device User Manual 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. Only the dedicated mobile device that comes with this optical unit and complies with relevant safety standards can be used with the EVA System.

  • Page 11: Product Overview

    EVA 3 Plus: Device User Manual fluid. 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. To limit contamination, use recommended disinfectant agents between each exam.

  • Page 12: Components

    Neck strap Lens cleaning cloth 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.

  • Page 13: Get To Know The Eva System 3 Plus

    EVA 3 Plus: Device User Manual 2. Get to know the EVA System 3 Plus Back View (figure 1)
  • Page 14 EVA 3 Plus: Device User Manual Front View (figure 2)
  • Page 15 EVA 3 Plus: Device User Manual Left View (figure 3) Right view (figure 4)

  • Page 16: Connecting To The Eva Stand Or A Neck Strap

    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.
  • Page 17 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.

  • Page 18: Turning On The Led Light

    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)

  • Page 19: How To Capture A Clinically Useful Image

    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.

  • Page 20: Positioning

    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.

  • Page 21: Illumination

    EVA 3 Plus: Device User Manual 3.3. Illumination The cervix should be fully illuminated and without glare. The LED light is powered by a rechargeable battery contained within the optical unit. The battery has charge capacity sufficient for approximately 10 hours of continual use.

  • Page 22: Focus

    EVA 3 Plus: Device User Manual 3.4 Focus There are two ways to adjust the colposcope focus. 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.

  • Page 23: Charging

    EVA 3 Plus: Device User Manual After you have captured images, it is important to review the images to verify they are clinically useful. 4. Charging The EVA System includes two components: the optical unit and mobile device. Each needs to be charged separately.
  • Page 24 EVA 3 Plus: Device User Manual (figure 15) The Charge Indicator Lights can be found above the charging port on the front of the optical unit. When connected to the charger, the lights will turn on and turn green while charging.
  • Page 25 EVA 3 Plus: Device User Manual Charge indicator lights- charging mode...

  • Page 26: Charging The Mobile Device

    EVA 3 Plus: Device User Manual 4.2. Charging the Mobile Device To charge the mobile device when it is fitted within the optical unit, connect the Micro- USB cable to the charging port built-in to the unit. To access the port, raise the charging port cover located above the LED light on/off switch..

  • Page 27: Taking The Mobile Device Out Of The Optical Unit

    EVA 3 Plus: Device User Manual 5. Taking the Mobile Device out of the Optical Unit The mobile device should be taken out of the optical unit when capturing full body images. To remove the mobile device from the optical unit: a.
  • Page 28 EVA 3 Plus: Device User Manual To remove the mobile device from the optical unit: (figure 17) To insert the mobile device into the optical unit (figure 18):...
  • Page 29 EVA 3 Plus: Device User Manual (figure 18) To secure the phone into the EVA System device, preventing users from removing the phone from the optical device...

  • Page 30: Care And Maintenance

    EVA 3 Plus: Device User Manual 6. Care and Maintenance 6.1 Storage We recommend leaving the colposcope in its provided case for protection and to minimize dust contamination when not in use. Always follow the cleaning process outlined below prior to returning the unit to its case to avoid contamination.

  • Page 31: Troubleshooting & Support

    EVA 3 Plus: Device User Manual Don’t clean the unit when the rubber cover over the charging port is open to avoid damage to the charging port. Continue by wiping the lens around the perimeter of the aluminum tube with a dedicated optics cleaning tool.

  • Page 32: Burned Out Led Light

    EVA 3 Plus: Device User Manual alternative USB cable. c. If the LED light still does not turn on after charging, contact customer service. 7.1.5. 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.

  • Page 33: Lens Troubleshooting

    EVA 3 Plus: Device User Manual 7.2. Lens Troubleshooting 7.2.1. Lens Cracks or Misalignment If a cracked or misaligned lens is causing artifacts or low-resolution images, contact customer service to replace the lens. 7.2.2. Dirt on Lens If dirt on the lens causes artifacts or low-resolution images, the user should clean the lens.

  • Page 34: Cracked Mobile Device Screen

    EVA 3 Plus: Device User Manual 7.3.4. Cracked Mobile Device Screen If the mobile device screen is cracked or has been compromised due to a fall or other form of damage, contact customer service. 7.4. EVA Application Troubleshooting 7.4.1. Unresponsive EVA Application...

  • Page 35: Specifications

    EVA 3 Plus: Device User Manual 8. Specifications Item Specification Technical Data Power requirements Charger Input Voltage 100-240 AC As rated by dual port MicroUSB charger Frequency 50/60 HZ, as rated by dual port MicroUSB charger Output 5.2V DC Optical Unit (HxWxD) Dimensions 24.39 cm x 8.1cm x 10.41 cm...
  • Page 36 EVA 3 Plus: Device User Manual Operating Environment Ambient temperature 50°F (10°C) to 104°F (40°C) Relative humidity 95% max Atmospheric pressure 70kPa/10.1psi to 110kPa/16psi Transportation and Ambient temperature -4°F (-20°C) to 104°F (40°C) Storage Environment Relative humidity 10% - 70% Atmospheric pressure 57kPa/8.3psi to 102kPa/14.7psi...

  • Page 37: Electromagnetic Compatibility - Manufacturer Declaration

    – to check the equipment for correct operation under the conditions of use. ● The use of accessories other than those specified or sold by MobileODT as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the unit. 9.1. Electromagnetic emissions ●...
  • Page 38 EVA 3 Plus: Device User Manual CISPR 11 interference in nearby electronic equipment. The ​ E VA System 3 Plus​ is suitable for use in all establishments, including domestic establishments and those directly connected to the public RF emissions Class B low-voltage power supply network that supplies buildings used for domestic purposes.
  • Page 39 EVA 3 Plus: Device User Manual Guidance and manufacturer's declaration – electromagnetic immunity – EVA System 3 Plus The ​ E VA System 3 Plus​ is intended for use in the electromagnetic environment specified below; the customer or the user of the ​ E VA System 3 Plus​ should ensure it is used in such an environment.
  • Page 40 EVA 3 Plus: Device User Manual electromagnetic site survey ,​ should be less than the compliance level in each frequency range .​ Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

  • Page 41: Recommended Separation Distances

    EVA 3 Plus: Device User Manual 9.2. Recommended separation distances The ​ E VA System 3 Plus​ i s intended for use in an electromagnetic environment ​ in which radiated radio frequency disturbances are controlled. The user and/or installer of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment (emitters) and the ​...

  • Page 42: Replacement Parts And Technical Service

    +1-617-454-4687 www.mobileodt.com Disclaimer: All specifications for the product are subject to change without notice. MobileODT assumes no responsibility for any injury that may result from illegal or improper use of the EVA System, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual.

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