Adaptica 2WIN Operator's Manual
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Adaptica 2WIN Operator's Manual

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2WIN
OPERATOR MANUAL
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Summary of Contents for Adaptica 2WIN

  • Page 1 2WIN OPERATOR MANUAL...

  • Page 2: Revision Notes

    2WIN/2WIN-S 5.6.0 Publication date 2022/02/17 Hardware configuration Version 37.1 Rev Num. 10.0_EN General notes Family: 2WIN VISION ANALYZER Family intended use: Portable instruments for the measurement of binocular and monocular refraction based on infrared photorefraction Models: 2WIN, 2WIN-S, 2WIN-S PLUS...

  • Page 3: Table Of Contents

    ..............................9 PPLICATIONS 6.3 E ..............................10 XAM CONDITIONS 6.5 M ..............................10 EASUREMENT TIPS DESCRIPTION OF THE DEVICE ......................................11 7.1 2WIN ..................................11 7.2 L ..................................12 ABELS 7.3 P ..............................13 ACKAGE LABELING 7.4 I ................................14 NTERFACES 7.5 G...
  • Page 4 I CONNECTIVITY 10.3 P 2WIN SC ..................41 AIRING AND TRANSFERRING A EXAM TO ISION REMOTE CONTROL: 2WIN APP-CONNECTION WI-FI ................................47 APPLICATIONS ........................................... 47 SOFTWARE UPDATE INSTRUCTIONS ....................................47 13.1 M ............................ 47 ANUAL UPDATE PROCEDURE 13.2 A ..........................47 UTOMATIC UPDATE PROCEDURE MAINTENANCE AND CLEANING INSTRUCTIONS ...................................

  • Page 5: Manufacturer Identification

    1 Manufacturer identification Manufacturer Adaptica S.r.l. Address Via San Marco, 9/H 35129 Padova (PD) Italy Telephone +39 049 773 968 Mail contact@adaptica.com www.adaptica.com 2 Legend of symbols Manufacturer identification data Date of manufacturing Electrical / electronic device subject to the WEEE Directive...

  • Page 6: Intended Use Of The Device

    3 Intended use of the device Instrument for the measurement of binocular and monocular refraction based on infrared (IR) photorefraction. 4 Classification and Applied Standards Classification according 93/42/EEC, Annex and MDR 2017/745 EU, Annex VIII Class IIa. IP classification IPX0 (degree of protection provided by the external plastic shells with reference to the penetration of any special material or water).

  • Page 7: Precautions

    RF communications equipment shall be used no closer than 30 cm (12 inches) to any part of the 2WIN, including its cables. The area where the device is to be installed has to comply to the IEC/ISO standards related to the medical use of an area.
  • Page 8 Any USB wall adapter and any battery charger used to charge the battery, when not provided by the manufacturer, shall comply EN 60950-1. The battery of the 2WIN cannot be replaced with equivalent item not provided by Adaptica, for safety reason (risk of explosion).

  • Page 9: Quick User Guide

    Carefully read Chapter 5 Precautions of the present manual before operating the device. • The 2WIN is a portable binocular vision analyzer. It measures refraction of both eyes at the same time. • The 2WIN should not be confused with a table-top auto-refractometer (AR). ARs are designed to measure refractive errors of one eye at time, in an artificial condition of far fixation.

  • Page 10: Exam Conditions

    For higher refractive errors (above +15 D and below -15 D), the 2WIN still displays “high M” or “high H”: in this case, the 2WIN will not display a numerical result, but it will write “N.A.”...

  • Page 11: Description Of The Device

    ATTENTION: during any data access to the 2WIN data and, in particular when connecting 2WIN to a computer via USB or Wi-Fi, the SD card of 2WIN must be inside the 2WIN SD card connector (SD card filesystem must be FAT32).

  • Page 12: Labels

    7.2 Labels Label Detail Explanation Manufacturer identification data: name and address Model name Serial number CE mark and Notified Body identification code Electrical / electronic device subject to the WEEE Directive on waste disposal FCC ID Identifies the Wi-Fi/Bluetooth transmitter module DEPRACATED LABELS –...

  • Page 13: Package Labeling

    7.3 Package labeling +39 049 773 968 Label Detail Explanation Manufacturer identification Data: name and address Fragile – handle with care This side up – do not reverse Keep dry Storage minimum and maximum temperature Lithium ion batteries contained or packed with device Call +39 049 773 968 for more information...

  • Page 14: Interfaces

    7.4 Interfaces Inside the USB & SD connection door there are a Micro-USB port and a MicroSD card holder. A summary of the functions of the buttons is reported below. Short press Long press MAIN FUNCTIONS Start focusing phase; Patient side BUTTON S1 &...
  • Page 15 Buttons S1 and S2 share the same function. On one hand, for example, a right-handed user can start a measurement with button S1; on the other hand, a left-handed user can turn the device upside down and use button S2. Long CENTER push the JOYSTICK to display the “Contextual help”, that explains buttons functionality.

  • Page 16: Graphical User Interface

    7.5 Graphical user interface The graphical user interface is displayed in these figures:...

  • Page 17: Operative Information

    The MicroSD memory card, besides containing the electronic version of the manuals, it contains also presentations and further instructions on how to operate the device. For further information regarding 2WIN and its Applications, please refer to video tutorials that can be found in the Adaptica’s YouTube channel: https://www.youtube.com/user/AdapticaSrl.

  • Page 18: Extract Battery

    The recharge via USB port connected to a computer is not allowed. Do not use 2WIN batteries more than 3 years old. Do not use swollen or damaged batteries. The device will not be able to perform any exam while connected via Micro-USB port...

  • Page 19: Before Operation

    When turned on the first time, 2WIN presents a disclaimer related to the management of data telemetry of the instrument. The operator is asked to read the document and accept the terms, if not 2WIN will work but some functionalities will be disabled (Telemetry and Remote access). You can read the document at the end of this manual (Appendix A) for all the details.

  • Page 20: Operative Instructions

    9 Operative instructions To power on the 2WIN, push BUTTON A. To turn OFF the device, long press BUTTON A and then, when the question “Are you sure you want to quit?” appears, push the JOYSTICK to answer OK. While the instrument is on, the monitor reduces the brightness after 30 seconds of inactivity. Then the monitor switches off after 30 more seconds.

  • Page 21: Device Setup

    After clicking on the JOYSTICK to answer OK, press S1 or S2 button to start the evaluation: Wait for the “age circle highlight” to disappear and read the VIS and IR values. VIS and IR represent respectively visible light evaluation (0 to 65535 range) and infrared light evaluation (0 to 255 range) Press S1 or S2 button to stop the evaluation.
  • Page 22 • RIGHT EYE: only right eye is measured; the blue rectangle covers only the corresponding area (left side of the display). • BOTH EYES: both eyes are measured; the blue rectangle covers the entire display. The choice is shown by the presence of the signs OS, OD, or both on the appropriate side of the display. There is an inversion of left and right due to the fact that the patient and the machine are one in front to the other.

  • Page 23: Preparation Of The Patient

    When the bar is RED, the distance between 2WIN and patient is wrong. Adjusting the distance to 1m will focus the image and obtain a GREEN top bar. The main steps to perform a measurement will be described in the following.
  • Page 24 Screen examination – blurred, not in focus. Adjust the distance from the patient Adjust the distance to focus the image until the top bar is green and the focusing indicator based on corneal reflex shape appears in the center of the screen. When the top bar is PERMANENTLY green and the focusing indicator (in the center of the image) reaches the highest peak (as shown in the following photo) release the BUTTON S1/S2: Examination screen –...
  • Page 25 7 D of spherical equivalent. If “N.A.” is displayed when “High M/H” appears, it indicates that the refraction is outside the range of the 2WIN’s measurement range. In case of binocular measurement, two values are shown overlapped to the image, inside the blue rectangle.

  • Page 26: Browsing Mode

    Please, refer to the following sections for detailed information of some of the abovementioned options. 9.5 Browsing Mode The browsing mode allows to recover patient's data previously saved in the 2WIN’s SD memory, by holding the JOYSTICK downwards from the home window. Pushing the JOYSTICK up or down allows to switch between different patients;...

  • Page 27: Zoom Function

    9.6 Zoom function When the measurement is completed, the operator can zoom on the acquired patient’s pupils. To do so, short press the BUTTON B. To go back to the main visualization, short press the BUTTON A. The Zoom function has two options, on the bottom left of the screen: the Zoom (lens) and the Pan (hand). The option in use is indicated with a lighter square.
  • Page 28 Pan Function The Pan function allows you to locate any detail of the image. After selecting it, you must use the JOYSTICK to browse in the image (hold the button for rapid movement). After positioning on the detail, you can change the function to the zoom power you want through the JOYSTICK.

  • Page 29: Menu

    Alerts: allows to activate the ending beep at the end of the measurement. o Fixation configures the interactivity light: Rainbow Fixation: choice between four Intensity levels for the visible LEDs in front of 2WIN, and activation of a customer Sequence. The latter is configured by placing a custom file in the SD card (as explained in the Customization paragraph).
  • Page 30 WiFi Status: shows information about the current Wi-Fi connection. WiFi Config: allows to search and select a Wi-Fi network to connect to. WiFi Options: allows to set a 2WIN Password for the device, or to auto connect to known networks (Auto Connect WiFi).
  • Page 31 Light Meter enables an evaluation of the ambient light. o Raw Data Acquisition allows the save of every single image taken from the 2WIN in the MicroSD. Note that the Menu item “Raw Data Acquisition” is an advanced feature available ONLY for Service purposes, helped by specialized technicians.

  • Page 32: Spherical Equivalent

    9.9 Quick Menu To recall rapidly the most used functions of the 2WIN, the operator can activate the Quick Menu by keeping pressed BUTTON D. The Quick Menu items appear at the top right; the '+' button allows to add new items.

  • Page 33: Save Exam

    9.11 Save exam If the SD card is inserted, a set of 4 files for each examination are saved in it, into the folder “2WIN Exams”. A subfolder named “Exam #number date” is created, where date is the current date and number is a sequential number.

  • Page 34: Print To Portable Printer

    It can be enabled from Menu > Print > Options > Strip in Pdf. CSV Exporter Tool The 2WIN permits to export all the exams stored in the MicroSD card in a CSV file, by selecting Menu > Print > Export Patient.
  • Page 35 Pair the 2WIN device with your BT printer. Go to Menu > Settings > Bluetooth > Bluetooth Config, select your own printer and press the JOYSTICK’s center button. Be sure that the right BT icon appears in the bottom of the main 2WIN screen.

  • Page 36: Mail Printing

    9.13 Mail Printing It is possible to send via email the 2WIN’s exam results in PDF format. To activate this service, create a text file (*.txt file) named “mailPrinting.txt” in the SD root containing the email you want the files to be sent to (ex.

  • Page 37: Customization

    Some features of the device can be customized by the user. To do so, the user can remove the MicroSD from the device, write on it through a PC, then reinsert it in the device. Otherwise, the user can connect the 2WIN device to a PC via the provided USB cable.

  • Page 38: Notification Center

    2 seconds black rotating on blue with a 200ms delay and intensity 10 9.16 Notification Center This feature gives real-time monitoring of 2WIN’s messaging and logs. Three types of information are reported: notifications on the measurements, notifications on the Wi-Fi networking status and logins, and notifications on the additional software Applications installed.

  • Page 39: Screening Table

    9.18 Screening Table The Screening Table is the set of thresholds that are used by the 2WIN to determine if a patient is inside or outside the guidelines (AAPOS) for amblyopia detection screening. Visualization To display the Screening Table, select 'Show Current Table' from Menu >...

  • Page 40: Wireless Connections

    Bluetooth connectivity is enabled by default on the device. 10.2 Wi-Fi connectivity A 2WIN equipped with the Wi-Fi module can be connected to a Wi-Fi network, for the following tasks: a) transmit the 2WIN’s refraction results to the VisionFit SC; devices have to be connected to the same Wi-Fi (refer to Section 10.3 for the pairing instructions);...

  • Page 41: Pairing And Transferring A 2Win Exam To Visionfit Sc

    2WIN is turned off. Click on “WiFi Status” to (1) check if the 2WIN is connected to your network and to (2) determine the IP address of 2WIN.
  • Page 42 Once 2WIN is paired, it’s possible to transmit 2WIN’s objective refraction results to VisionFit SC, to speed up the subjective refraction measurement. On 2WIN’s display, the blue sphere on the right side of the Wi-Fi symbol indicates the connection with the VisionFit SC.
  • Page 43 To transfer 2WIN’s measurements to VisionFit SC follow the steps below: Perform a test using 2WIN and save it (or browse for an older exam). Short press the JOYSTICK downwards. 2WIN’s data appears instantly on the right side of the VisionFit SC application (Reference...
  • Page 44 The first time transferring an exam to VisionFit SC, the pairing needs to be performed as follows: 1. Enable “Bluetooth” on 2WIN from Menu > Settings. 2. From VisionFit SC’s tablet application, enter Settings and set 2WIN Connection type: BT...
  • Page 45 3. Afterwards, select 2WIN Connection. The pairing starts automatically. 4. Press on 2WIN icon to see a list of available devices: select the desired 2WIN. When the pairing is complete, a green circle appears on 2WIN’s icon. To transfer a 2WIN’s measurements to VisionFit SC follow the steps below:...
  • Page 46 Pairing does not have a preferred sequence order (VisionFit SC – 2WIN). It can also be performed in reverse order (2WIN – VisionFit SC). Pairing is needed only the first time. It must be performed again only if you change devices (2WIN or VisionFit SC).

  • Page 47: Remote Control: 2Win App-Connection Wi-Fi

    2WIN is connected to a Wi-Fi network with internet access, the update is notified on the screen. At 2WIN’s start-up, the system checks if a new update is available. If so, the new software version and release date are reported on the screen and the user can decide to download it or not.

  • Page 48: Maintenance And Cleaning Instructions

    After the extraction, 2WIN will prompt the request of immediate or delayed installation. If the OK button is pressed, 2WIN will restart and run the system update. Press the CANCEL button to delay it (the update will take place at the next 2WIN reboot).

  • Page 49: How To Clean The System

    If necessary, it’s possible to clean the 2WIN with a lightly moist microfiber cloth. It’s recommended to clean 2WIN’s lenses at least once a year – more frequently if it’s exposed to dust. Use compressed air to clean 2WIN’s frontal objective. Do not use solvents, sprays, or alcohol to clean the system.

  • Page 50: Troubleshooting

    Charge the battery appear on the display of the discharged device On the display, an error Electronic malfunctioning Contact support@adaptica.com, message appears mentioning serial number and error message On the display an error Software malfunctioning Contact support@adaptica.com, message appears...

  • Page 51: Additional Information

    Measurement precision for pupil diameter: ±0.2 mm Measuring range for inter-pupillary distance: 30 to 120 mm, step 0.1 mm Measurement precision for inter-pupillary distance: ±1 mm 16.2 2WIN Rechargeable battery specifications Type of Cell: Sealed Lithium-polymer Prismatic Battery Pack Model: CS-SP112XL Battery Pack Size: 58 X 36.1 X 12.7 (LxWxH mm)

  • Page 52: Other Specifications

    • Full speed Bluetooth® Piconet and Scatternet supported • USB 2.0 (Full Speed) for data and power source • Operates in 2.4 GHz Frequency bands Model: LM Technologies LM820 Compliance: IEEE 802.11b/g/n/d/e/h/i standards, Bluetooth® v2.1 + EDR, v3.0 and v4.0 standards •...

  • Page 53: Information For Assistance

    If the service department of Adaptica suggest this option, the customer/operator is asked to activate the “Remote Control” option of the 2WIN. This option can be enabled only in the 2WIN with Wi-Fi connection. Through the use of this option, a direct connection between the 2WIN and the IT department of Adaptica will be enabled in order to give direct support.

  • Page 54: Appendix A - Data Management Disclaimer

    Adaptica S.r.l., and will be kept by such company. The Telemetry Data will be used only in order to acquire anonymous information on the use of the instrument and to check that it is functioning correctly.
  • Page 55 (the “Supervisors”), together with this disclosure, will be made available at the registered office of Adaptica S.r.l. Finally, Adaptica S.r.l. informs that the law grants all the Parties Concerned the specific rights that are set out in Article 7 of the Privacy Code; purely by way of example and without limitation, these include the right to ask for, and obtain, confirmation of whether or not Telemetry Data of one’s own...

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