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MobileODT EVA 3 Plus, Руководство пользователя устройства

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EVA 3 Plus 

Enhanced Visual Assessment System

  

 

 

 

 

 

 

 

 

 

 

 

Device User Manual

 

Содержание EVA 3 Plus

Страница 1: ...EVA 3 Plus Enhanced Visual Assessment System Device User Manual ...

Страница 2: ...EVA 3 Plus Device User Manual 2 ...

Страница 3: ...es 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 Il...

Страница 4: ...ooting 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...

Страница 5: ...oubleshooting 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 5 ...

Страница 6: ...n For further support please contact us MobileODT LTD Ben Avigdor 8 Tel Aviv Israel 6721832 support mobileodt com 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 LEAR...

Страница 7: ...here 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 colposcop...

Страница 8: ...ical 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 8 ...

Страница 9: ...ed 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 b...

Страница 10: ...ttery 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 o...

Страница 11: ...t 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 discha...

Страница 12: ... 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...

Страница 13: ...EVA 3 Plus Device User Manual 2 Get to know the EVA System 3 Plus Back View figure 1 13 ...

Страница 14: ...EVA 3 Plus Device User Manual Front View figure 2 14 ...

Страница 15: ...EVA 3 Plus Device User Manual Left View figure 3 Right view figure 4 15 ...

Страница 16: ...g 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 l...

Страница 17: ... 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 17 ...

Страница 18: ...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 18 ...

Страница 19: ...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 ...

Страница 20: ... 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 20 ...

Страница 21: ...e battery has charge capacity sufficient for approximately 10 hours of continual use a The colposcope reduces glare with a polarizer however glare from the speculum reflection is still possible If this is the case reposition the colposcope and or the speculum until there is less glare b When holding the colposcope make sure not to block the LED light with your finger figure 12 figure 13 21 ...

Страница 22: ...cus 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 The recommended default setting for the fine focus wheel is to be fully extended If working at a distance which normally yields the clearest images doesn t work you can try adjusting the fine focus wheel so that the lens moves in and out until the correct focus is found figure 14 22...

Страница 23: ...r 150 countries is provided in order to allow for charging in different countries Power 30W Input 100 240V Output 3A 2 Technology iSmart Weight 100g Dimensions 50mm 43mm 42mm Certification CE FCC UL LVD 4 1 Charging the Optical Unit To charge 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 ...

Страница 24: ...e 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 Please Note The colposcope cannot be used while charging as the LED light will not be able to be switched on Charge indicator lights operation mode 24 ...

Страница 25: ...EVA 3 Plus Device User Manual Charge indicator lights charging mode 25 ...

Страница 26: ...ble 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 Connect the cable to a wall socket with the proper USB electrical port adapter The mobile device should be charged whenever the colposcope is not in use to ensure proper functionality during the examination figure 16 26 ...

Страница 27: ...he mobile device d e Please note When the mobile device is removed from the optical unit the image will look inverted If you are using the camera for imaging outside of colposcopy mode you must go to the EVA Application settings and uncheck colposcope mode This will allow normal uninverted imaging through the EVA application To insert the mobile device into the optical unit a Place the mobile devi...

Страница 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 28 ...

Страница 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 29 ...

Страница 30: ...e cloth provided in your care kit Never use towels 6 3 Body Base The optical unit needs to be cleaned between each and every use due to the colposcope accumulating dirt over time and the possibility of cross contamination 6 4 Cleaning Instructions Cleaning the base of the optical unit should only be done with CaviWipes disinfectant towelettes or their equivalent Use 3 5 towelettes at minimum to wi...

Страница 31: ... orange Also check if the LED light can be switched on and if not charge the battery 7 1 2 Battery Disconnection Contact customer service if the battery becomes partially or fully disconnected If your optical unit is fully charged but the LED light does not turn on or turns on and off this may indicate a battery disconnection 7 1 3 Overheating of Internal Board If you feel unusual heat while holdi...

Страница 32: ...s charging If this does not occur it may indicate that the LED light has burnt out In this case contact customer service 7 1 7 Optical Unit Casing If the optical unit casing is cracked or not intact leading to artifacts in the image or a low resolution image contact customer service 7 1 8 On off Switch If the on off switch is stuck contact customer service The optical unit is programmed to timeout...

Страница 33: ...when charging If the mobile device is charged and continues to turn off the user should contact customer service 7 3 2 Overheating If the mobile device overheats refer to the Samsung J530 user manual and follow the appropriate instructions and contact customer service if needed 7 3 3 Insufficient Memory Make sure there is enough memory available before starting an exam through the EVA Application ...

Страница 34: ...if required If the problem persists the user should check that the application is updated If the EVA Application is updated and still unresponsive contact customer service 7 4 2 Unwanted Deactivation If the mobile device operating system closes the EVA Application due to memory allocation and the device is not operational the user should restart the EVA Application If the problem persists the cont...

Страница 35: ...ions Optical Unit HxWxD Lens 24 39 cm x 8 1cm x 10 41 cm w lens 24 39cm x 8 1cm x 6 63cm w o lens 93 1mm long x 30mm diameter Weight Optical Unit Lens Mobile Device Total 345g 100g 160g 605g EVA System specifications For Samsung J530 Working distance magnification Field of view Depth of field 250mm 400mm 4 0X optical 16X with digital zoom at 225mm 3 8X optical 15X with digital zoom at 425mm 53mm a...

Страница 36: ...ure Relative humidity Atmospheric pressure 4 F 20 C to 104 F 40 C 10 70 57kPa 8 3psi to 102kPa 14 7psi LED light Lamp type Lamp voltage Polarizer White LED color temperature 6000K with a viewing angle at 50 Iv of 120 3 6V The 2W LED is operated at 1 16W providing 289 Lux of luminous flux at a beam angle of 14 degrees Linear polarizing laminated film cross polarized wavelength range 400 700mm Use l...

Страница 37: ...nt parts may have the consequence of increasing the emissions or decreasing the immunity of the unit 9 1 Electromagnetic emissions The EVA System is intended for use in the electromagnetic environment specified in the following tables 1 2 4 and 6 below The user and or installer of the unit must ensure that it is used in such an environment Table 1 Guidance and manufacturer s declaration electromag...

Страница 38: ...ow the customer or the user of the EVA System 3 Plus should assure that it is used in such an environment Immunity test IEC 60601 1 2 Test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity...

Страница 39: ...0 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 3 Plus including cables then the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 6 E P 80 M Hz to 2 5 GHz where P is the maximum output power rating of the transmitt...

Страница 40: ...adio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the EVA System 3 Plus is used exceeds the applicable RF com...

Страница 41: ...ions equipment and the EVA System 3 Plus Rated maximum output power of transmitter Watts W Separation distance according to frequency of transmitter in meters Meters m 80MHz to 2 5GHz d 6 E P 0 01 0 06 0 1 0 19 1 0 6 10 1 90 100 6 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the...

Страница 42: ...cifications 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 Contents of the User Guide and other written materials provided ...

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