Adaptica 2WIN-S Operator's Manual
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Adaptica 2WIN-S Operator's Manual

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OPERATOR MANUAL
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Summary of Contents for Adaptica 2WIN-S

  • Page 1 2WIN-S Plus 2WIN-S 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

    6.2 E ............................... 9 XAM CONDITIONS 6.3 M ..............................10 EASUREMENT TIPS DESCRIPTION OF THE DEVICE..........................10 7.1 2WIN 2WIN-S ..............................10 7.2 2WIN-S .................................. 10 7.3 P ..............................12 ACKAGE LABELLING 7.4 2WIN-S ..............................13 LABELING 7.5 I ................................15 NTERFACES OPERATIVE INFORMATION ..........................16...
  • Page 4 ....................34 INSTALLATION AND CONFIGURATION 12.2 R KALEIDOS A ........................36 EVIEW EXAMS USING 12.3 KALEIDOS A ............................37 SETTINGS 2WIN-S PLUS (PACKAGE) ..........................39 13.1 AI-A ..................39 ANOMALIES DETECTION HINT OF NTERIOR EGMENT 13.2 CR-A ........................41 CORNEAL REFLEXES APPLICATION 13.3 EMR...

  • 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. Classification and type of applied parts Class I, Type B.

  • Page 7: Precautions

    RF communications equipment shall be used no closer than 30 cm (12 inches) to any part of the 2WIN-S, 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 Inside the 2WIN SD memory card is stored the patient data. This information can contain personal information such as name/surname/age. This information management is responsibility of the operator. Only the power adapter provided by Adaptica with the system can be used to charge the 2WIN-S’ battery pack, for safety reasons.

  • Page 9: Quick User Guide

    Carefully read Chapter 5 Precautions of the present manual before operating the device. • The 2WIN-S is a stand-alone binocular vision analyzer. It measures refraction of both eyes at the same time. • The 2WIN-S 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: Measurement Tips

    The 2WIN-S performs the measurement 1 meter (3 feet 3 inches) away from the patient’s eyes, with continuous tracking of the corneal reflex, for the analysis of the binocular alignment. The device works as a...
  • Page 11 The 2WIN-S accepts a pupil diameter between 4 and 7 mm and it is compatible with the measure both in mydriasis (dilation of the pupil) and in miosis (constriction of the pupil). It is possible to measure down to 3.5 and up to 11 mm, but this depends on several conditions. Outside the 4-7 mm range the overall precision could decrease.

  • Page 12: Package Labelling

    7.3 Package labelling +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 13: 2Win-Slabeling

    7.4 2WIN-S labeling Label Detail Explanation Manufacturer identification data: name and address model: 2WIN-S Model name Connector polarity Input C.C. voltage and current 2.5A CE mark and Notified Body identification code Electrical / electronic device subject to the WEEE Directive...
  • Page 14 BACK INDOOR CONTROL PANEL UPPER SIDE...

  • Page 15: Interfaces

    7.5 Interfaces 2WIN-S The customer can operate the 2WIN-S from the control panel depicted in figure. The buttons’ role is described in the following, and also in Section 9.1. A: BUTTON 1 - "Measurement” Press for 2 sec to start a new measurement B: BUTTON 2 - “Connection”...

  • Page 16: Operative Information

    BUTTON D Start a new exam * *: This function is operating only if the “KALEIDOS mode” is switched on (default in 2WIN-S configuration); otherwise, the functionality of BUTTON D will be different. Refer to Section 7.4 and 9.7 of 2WIN Operator Manual for further information.

  • Page 17: Unpacking

    Please, note that operator can have access to 2WIN menu if, and only if, the KALEIDOS App is not – connected to the 2WIN-S device. Refer to Chapter 12 Remote control: KALEIDOS App of the manual. The Menu is activated by pressing the center of the JOYSTICK. To exit the Menu, push left on the main Menu...

  • Page 18: Before Operation

    When turned on the first time, 2WIN-S present 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-S 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 19: Device Setup

    In order to monitor the battery charge level, press the battery charge button. Configuration steps Refer to Chapter 11 of this Operator Manual for 2WIN-S configuration using the Wi-Fi tablet application (deprecated legacy feature). The 2WIN-S configuration using the Bluetooth tablet application (KALEIDOS App) is briefly described in the following.

  • Page 20: Preparation Of The Patient

    Patient age 2WIN-S uses the patient’s birthdate / age range as a corrective parameter to determine the refraction. This information is used in particular to compensate accommodation in young patients with hyperopia-based refraction error. Take care of selecting the right birthdate / age range before taking the measurement. Take into consideration that the default age range is 0-2 years.

  • Page 21: Measurement

    9.3 Measurement Turn the 2WIN-S ON by pressing the ON/OFF button for 1 sec. A beep sound stands for 2WIN-S turning ON. Select “Start a new measurement” from the KALEIDOS App’s main page. Insert the patient’s name and date of birth. When the date of birth is set, the age range is automatically selected.
  • Page 22 A one-beep sound indicates that the measurement was taken, while a two-beep sound indicates that the measurement has been correctly processed (this is an option selectable from the 2WIN inside 2WIN-S, in Menu > Measurement > Sound > Alerts > Ending Beep).
  • Page 23 A measure with a low reliability index (less than R6) should be repeated. If “N.A.” is displayed, it indicates that the refraction is outside the range of the 2WIN-S measurement range. Numbers for “Pupil” and for “Gaze” represent, for OD and OS respectively, pupil diameters, horizontal and vertical (in this order) offset angles of the average position of the corneal reflex on respect of the center of the detected pupil.
  • Page 24 From the results screen the options are: 1. Press on the ‘Image’ button on the top right of the results window to visualize the patient’s eyes and pupils’ images:...
  • Page 25 2. To see the screening results, press on the “Info” button on the top right: 3. Tap on the PDF icon below the screening results table to generate the PDF report of the exam. As an alternative, tap on the PDF icon on measurement results window:...
  • Page 26 4. Click on the three dots on the top right corner to save or repeat the measurement (a dropdown menu appears). If you repeat the measurement, current patient data will be kept:...

  • Page 27: Save Exam

    *.json = internal file (for service purposes only). CSV Exporter Tool The 2WIN-S permits to export all the exams stored in the MicroSD card of 2WIN in a CSV file, by selecting Menu > Print > Export Patients from 2WIN inside 2WIN-S.

  • Page 28: Gaze

    9.5 Gaze The maps on the two bottom corners of the results screen indicate the eye position (Gaze). This is calculated based on the corneal reflex positions, but compensated because the light is not centered, and the direction of eye movement is opposite compared to the movement of the reflex. The Gaze shows the displacement of the visual axis with respect to the pupil center.

  • Page 29: Wireless Connections

    Refer to Section 10.1 of 2WIN Operator Manual for further information. 10.2 Wi-Fi connectivity A 2WIN-S device that is equipped only with the Wi-Fi module can be connected to a Wi-Fi network, for the following tasks: a) control remotely the 2WIN-S through the 2WIN App-Connection Wi-Fi, running on Android tablets: this is an unsupported legacy feature, reported only for backwards compatibility;...

  • Page 30: Pairing And Transferring A 2Win-Sexam To Vision Fit Sc

    VisionFit SC is a mobile and wearable subjective refractor which can be used in combination with 2WIN-S. Once 2WIN-S is paired it is possible to transmit its objective refraction results to VisionFit SC, to speed up the subjective refraction measurement.
  • Page 31 2. From VisionFit SC’s tablet application, enter Settings and set 2WIN Connection type: BT 3. Afterwards, select 2WIN Connection. The pairing starts automatically.
  • Page 32 To transfer a 2WIN-S measurement to VisionFit SC follow the steps below: 1. Perform a test using 2WIN-S and save it. 2. Enter the Reference area in VisionFit SC’s tablet application and tap on the 2WIN+ button. 3. 2WIN-S data will appear instantly on the Reference area in VisionFit SC’s application.

  • Page 33: Remote Control: 2Win App-Connection Wi-Fi

    4. Press TO MAIN button on VisionFit SC’s application to add data to the Subjective Area. Pairing is needed only the first time. It must be performed again only if you change devices (2WIN-S or VisionFit SC). Not available measurements from 2WIN-S can’t be transferred on VisionFit SC.

  • Page 34: Kaleidos App: Installation And Configuration

    • Lenovo TB-X605L • Lenovo TB-X306X You can download KALEIDOS App on your device from Adaptica’s website in the section Products > 2WIN-S > Technical Information > Downloads > KALEIDOS App BT. Tablet’s operating system updates are forbidden. They could compromise the KALEIDOS App’s functioning.
  • Page 35 At the next launch, KALEIDOS App will automatically reconnect to the paired 2WIN-S unless the user disconnects it. KALEIDOS App is intended to be used to control 2WIN-S and it does not allow 2WIN remote control. KALEIDOS App is compatible with 2WIN-S having software version 5.4.2 or higher, and hardware version 29.1 or higher.

  • Page 36: Review Exams Using Kaleidos App

    Exams acquired in Refraction mode report the indication of the examined eye: both eyes, left eye, or right eye. Corneal Reflexes exams, instead, are marked with a “CR Mode” label. Refer to Chapter 13 – 2WIN-S Plus for further information on the Corneal Reflexes exam.

  • Page 37: Kaleidos App: Settings

    12.3 KALEIDOS App: settings KALEIDOS App allows to read several parameters of the 2WIN-S and to configure the Wi-Fi connection. To enter the Settings menu, select “App & device setup” from the Application’s main window. GENERAL In the GENERAL tab the following information are displayed: •...
  • Page 38 WI-FI CONNECT From the WI-FI CONNECT tab it is possible to scan for the available Wi-Fi networks and to connect to them. CUSTOMIZATION From the CUSTOMIZATION tab, it is possible to personalize the PDF report’s footer and set up the EMR connection (for the latter refer to Section 13.3).

  • Page 39: 2Win-S Plus (Package)

    2WIN-S is not able to refract the patient. Anterior Segment Hint is already active if you are using a 2WIN-S Plus. To activate the AI-App whether not having the Plus configuration, please contact your local distributor to get the update and the activation code.
  • Page 40 If AI-App is enabled on your 2WIN-S and if the tablet is connected to a Wi-Fi network having internet access, the cloud icon on KALEIDOS App is blue, as shown in the figure below. Otherwise, the cloud icon is grey.

  • Page 41: Cr-App: Corneal Reflexes Application

    The measurement shall in any case be used to refer the patient to an eye-care professional for further evaluation. If any error occurs during the connection to Adaptica Cloud or during the upload of the pupils’ images, the cloud icon changes to cloud error icon: 13.2 CR-App: corneal reflexes application...
  • Page 42 CR measurement mode is already active if you are using a 2WIN-S Plus. Otherwise, whether having only the 2WIN-S, to request the activation code, please contact your local distributor. To enable Corneal Reflexes measurement mode, tap on the standard measurement mode icon (infinite symbol) on the home page of the application: “Measurement Type”...
  • Page 43 Default mode is 2WIN-S (Refraction) mode. When KALEIDOS App is restarted 2WIN (Refraction) mode is loaded. CR Exam Procedure CR exam consists of a sequence of three acquisitions: one binocular and two cover tests under an infrared occluder. The patient must look at the white LED that turns on during the measurement.
  • Page 44 5. Ask the patient to look inside the 2WIN-S and at the white light. Press on one of the ‘pause’ buttons to start the corresponding exam. You can perform the three measurements in any order. When you perform any of the cover tests use the IR occluder provided by Adaptica to cover the contralateral eye.
  • Page 45 You can also start a CR exam just after a 2WIN-S (Refraction) exam, by tapping on the CR button in exam’s Measurement Result window. The CR exam will start with the same patient data.
  • Page 46 4. Do not press the occluder against the eye: eyelid movements shall be possible and comfortable. 5. Look into 2WIN-S keeping the occluder in the correct position. Pay attention to fit 2WIN-S’ aperture: ambient light must not enter the device during the exam.

  • Page 47: Emr Connection Set-Up

    When a manifest asymmetry of the corneal reflexes is detected without cover test the output is: ET (esotropia) or XT (exotropia). When an asymmetry of the corneal reflexes appears only under infrared cover test the output is: EP (esophoria) or XP (exophoria). If a vertical deviation is present the output follows the same rules above mentioned: HT (hypertropia), IT (hypotropia), HP (hyperphoria), IP (hypophoria).
  • Page 48 The EMR connection feature is already active if you are using a 2WIN-S Plus. Otherwise, whether having only a 2WIN-S, to request the activation code to enable EMR connection, please contact your local distributor. To setup the EMR connection follow these steps: 1.
  • Page 49 1. Select a patient in your EMR system. The CSV input file is instantly created in the Shared Folder. 2. Start a new 2WIN-S (Refraction) measurement from the KALEIDOS App. The app imports the patient data from the CSV input file and displays it. After the import is completed, the app will delete the CSV input file from the Shared Folder.

  • Page 50: Software Update Instructions

    When the software update procedure is performed, the 2WIN-S’ battery must be fully charged. The last Firmware version is 1.6. If the 2WIN-S is not using this version (you can check it in the 2WIN Menu > Help > About > BP), please download the latest version at adaptica.com > Products > 2WIN-S >...

  • Page 51: Disinfection

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

  • Page 52: Maintenance And Cleaning Instructions

    16.4 Instructions for correct disposal of 2WIN-S packaging 2WIN-S’ packaging is made of expanded polyethylene foam, present inside the device’s suitcase and between the suitcase and the shipment box. Such foam is eco-friendly and 100% recyclable.
  • Page 53 Users have a fundamental role in contributing to reuse, recycling, and recovery of WEEE. The potentially dangerous substances contained in the WEEE can pollute the environment and produce harmful effects to the human health. Below are a few indications of specific dangers of some substances, which may leach in the environment and in the water system.

  • Page 54: Troubleshooting

    17 Troubleshooting Symptom Possible cause Solution The KALEIDOS App cannot find the The battery is completely Charge the battery 2WIN-S discharged On the display, an error message Electronic malfunctioning Contact support@adaptica.com, appears mentioning the serial number and error message On the display, an error message Software malfunctioning Contact support@adaptica.com,...

  • Page 55: Additional Information

    Measuring range for inter-pupillary distance: 30 to 120 mm, step 0.1 mm Measurement precision for inter-pupillary distance: ±1 mm 18.2 Rechargeable batteries specifications 2WIN-S Type of Cell: Lithium-ion Cylindrical Cells: 4 x Panasonic NCR18650B Rated capacity: 4 x 3400 mAh (13600 mAh) Rated voltage: 4 x 3.7V (14.8V)

  • Page 56: Wi-Fi Modules / Bluetooth Adapters

    Replace No.: Sony: PSP-110 Charger model: Lvsun CPSC110; Input: 90-250Vac 50/60Hz 100mA; Output: 4.2-8.4Vdc 800mA 18.3 Wi-Fi modules / Bluetooth adapters Model: LM Technologies LM817 Compliance: IEEE 802.11b/g/n/d/e/h/i standards, Bluetooth® v2.1 + EDR, v3.0 and v4.0 (Dual Mode) standards • Wi-Fi 802.11 b/g/n •...

  • Page 57: 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-S. This option can be enabled only in the 2WIN-S with Wi-Fi connection. Through the use of this option, a direct connection between the 2WIN-S and the IT department of Adaptica will be enabled in order to give direct support.

  • Page 58: 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 59 “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...

  • Page 60: Appendix B - Emr Input And Output Files Specifications

    Adaptica distributor can perform the needed modifications in your EMR system. This is a “full” integration, i.e., patient name or ID is sent from the EMR system to 2WIN-S, and measurement/screening results are saved to data fields within the patient’s EMR.
  • Page 61 • Some input file fields could be empty. However, last name, first name and date of birth fields are mandatory. Example: Smith,John,2016-02-24,,,,0 is a valid input file. Output file specifications The output file presents information in a CSV file. Comma separators are used. There are no headers in the first line.

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