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Revision notes Software configuration version 2WIN/2WIN-S 5.5.0 Publication date 2020/03/31 Hardware configuration version Version 31.1 and earlier Rev Num.
2 Legend of symbols Manufacturer identification data Date of manufacturing Electrical / electronic device subject to the WEEE Directive on waste disposal CE mark: this device complies the base requirements of the Medical Device Directive 93/42/CEE Direct current (DC) Warning: necessary information for safety Important information Read user manual before use Indoor use only...
3 Glossary Accommodation: The power (or ability) of the eye to alter the shape of its lens so that it can adjust the focus of the eye for distance and closeness. Anisometropia A condition in which the refractive power of the eyes is unequal.
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Hyperopia Farsightedness is a refractive error in which the image does not come to focus before striking the retina in the relaxed eye. Accommodation may be used to overcome small amounts of hyperopia. Monocular Involving the use of a single eye. Myopia Nearsightedness is a refractive error in which the point of focus for light rays is in front of the retina, resulting in...
Class IIa 5.2 Classification and type of applied parts When used without the KALEIDOS accessory, there are no applied parts. When used in the 2WIN-S configuration, with the KALEIDOS accessory, the applied part is Class I, Type B. 5.3 IP classification IPX0 (degree of protection provided by the external plastic shells with reference to the penetration of any special material or water).
6 Precautions Electromagnetic compatibility This device has been tested and found to comply to the limits for medical devices contained in IEC60601-1-2 and in Medical Device Directive 93/42/EEC. These limits are intended to provide reasonable protection against harmful interference in a typical medical installation.
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KALEIDOS battery pack, for safety reason. In the 2WIN-S configuration, do not use the tablet while it is connected to the power supply. The battery of the 2WIN and the cells of the KALEIDOS cannot be replaced with...
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The device needs to be operated in a semi dark room, in order to help pupil dilation. This rule does not apply to the 2WIN-S configuration, when the KALEIDOS is applied. Do not use different configuration of 2WIN and KALEIDOS to compose the 2WIN-S.
7 Quick user guide Register your 2WIN: registration takes less than 1 minute! It's highly recommended to register your 2WIN at: http://www.adaptica.com/user-registration/ Important • Read carefully the Chapter 6 – Precautions of the present manual before operating the device. • The 2WIN is a binocular refractometer and vision analyser. It measures refraction of both eyes at the same time, at the distance of 1 meter.
• It automatically measures binocular refraction, pupil distance, pupil size, direction of gaze, and fixation abnormalities. 7.2 Main Applications • Refraction of infants and children from 2 months of age, seniors, impaired and non- cooperative patients. • Early detection and documentation of multiple amblyogenic factors. •...
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patient's age. To change the patient age “long-press” to the RIGHT button of the joystick and follow the instructions in the 2WIN display. • Instruct the patient to keep his/her eyes wide open, clear of eyelids or eyelashes, and to fixate the centre of the camera. Hold the 2WIN horizontally with both hands, approximately at the same height of the patient’s eyes, and at a distance of 1 meter.
Data Processing message After Data Processing measurement results will be displayed. Measurement screen 7.5 Measurement tips • For both Sph and Cyl, measurement accuracy is ± 0.25 D in the range of ±5 D. The cylinder axis is calculated between 1° and 180° (step 1°) with precision of ±5°. For higher refractive errors, the 2WIN displays “high M”...
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• If you wish to refract infants, young children and any non-cooperative patients, you can turn the audible and/or the visible fixation targets ON. Audio fixation (attraction system) is preferable to the visible small lights fixation. • Make sure the Reliability Index of the refraction measurement is higher than 6 (max. is 9).
8 Description of the device 8.1 2WIN The measuring principle of the device is based on infrared photorefraction. In this technique, infrared light is projected through the pupils of the patient onto the retina. Depending on the refractive error, the reflected light forms a specific crescent-shaped brightness pattern within the pupil.
2WIN to a computer via USB or WiFi the SD card of 2WIN must be inside inside the 2WIN SD card connector (SD card filesystem must be FAT32). 8.2 2WIN-S 2WIN-S comprises 2WIN and KALEIDOS, an accessory. Please refer to Chapter 12 – KA- LEIDOS.
8.3 Labels Label Detail Explanation Manufacturer identification data: name and address Model name Serial number, including manufacturing date: 2WIN = model code D = year (A=2009 B=2010 ..) F = lot 00001 = unique serial number Battery operating voltage CE mark and Notified Body identification code Electrical / electronic device subject to the WEEE Directive...
8.4 Package labeling Label Detail Explanation Manufacturer identification Data: name and address Fragile – handle with care This side up – do not reverse Keep dry Storage minimum maximum temperature...
8.5 KALEIDOS labeling (2WIN-S only) 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...
8.6 Interfaces Front View Rear View Inside the USB & SD connection door there are a Micro USB port and a Micro SD card holder.
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Open connection door On the bottom of the device there is also a 1/4”-20 threaded hole for a tripod. A summary of the functions of the buttons is reported below. Patient side: BUTTON S1 & S2 Operator side: BUTTON A BUTTON B CROSS BUTTON BUTTON C...
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• push CENTRE to enter menu or to say OK; o push RIGHT to go down into the submenu; o push LEFT to go up from the submenu; o push UP to scroll up the menu; o push DOWN to scroll down the menu; •...
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All the button functions are summarized in the following figure: (* In KALEIDOS mode) KEY- DATE SCREEN BUTTON HOME BROWSE MENU IN MEASURE BOARD TIME Hold A on/off on/off 2WIN Applications Exit Exit cancel cancel exit Hold B print Print Zoom Zoom Change field...
9 Operative information 9.1 Operating conditions The device needs to be operated under the following environmental conditions: 10 – 40 C° (50 – 104 F°) Temperature: Humidity (max): 90% not condensing 9.2 Unpacking The box contains (default configuration): • the electronic version of the operating manual (inside the microSD) •...
9.4 Extract battery To extract the battery: slide completely the battery lock, hold it firmly and gently open the battery door located in the lower side of the device. WARNING: Don't try to force the opening of the battery door if the battery lock is not completely opened.
9.5 Battery-charging Please load the batteries with the external battery charger provided. On first usage the battery needs to be charged for at least 4 hours. Batteries must be charged at least once every 30 days. Slide completely the battery lock and extract the battery, insert the battery into the external battery charger.
Please notice that the device will not be able to perform any exam while connected via micro-USB port. When the device is connected to a computer via USB port the turning off is prevented. When you try to switch off the 2WIN a warning will advise you to remove USB cable.
9.8 Software language 2WIN Software is available in the following languages: ▪ English ▪ French ▪ German ▪ Italian ▪ Spanish ▪ Turkish The default language for 2WIN Software is English. Follow these instructions to load a different language pack in your 2WIN: 1.
The software will advise when this operation needs to be done, according to the configuration. 2WIN-S, whose 2WIN hardware version is X.1, cannot charge the 2WIN battery via USB cable. The charge via USB cable is deprecated for the other 2WIN (hardware version X.0).
Power ON / Power OFF To power on the 2WIN device, push the BUTTON A. To power on the 2WIN-S device, push the on/off button on the Control Panel of the KALEIDOS. (To turn OFF the device long press the BUTTON A then, when the question “Are you sure you want to quit?”...
For a proper use of the device it is important to prepare the environment for the examination. ✓ Verify adequate light conditions Except when the device is used in the 2WIN-S configuration, with the KALEIDOS accessory applied, the ambient light should be dim, there should be no direct light pointed towards the instrument and every direct source of light should not be seen by the device or reflected by eyes of the patient.
Good light conditions are equivalent to a value of VIS between 30 and 80, and of IR less than 30. 10.2 Device setup As soon as powered ON, the device will perform a fast auto-test, then it will turn directly to exam mode, and the display will show the screen depicted below.
• LEFT EYE: only left eye is measured (the blue rectangle covers only the right side of the live area on the display). • RIGHT EYE: only right eye is measured (the blue rectangle covers only the left side of the live area on display). •...
light on light off sound on sound off 10.5 Patient data From version 5.0_170911 and above 2WIN uses the age of the patient information as a corrective parameter for determining the patient refraction. This information is used in particular to compensate accomodation in young patients with hyperopia-based refraction error.
Browsing mode: recall of a possible patient. When pressing the left arrow button the patient's data is shown overlaying the image for a couple of seconds. The following data are displayed: patient number, patient name, date of birth, age selection, folder name, exam date and software version used to acquire and save the exam.
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Measurement tips: usually the RED condition depends on a bad distance between the 2WIN and the patient. When the top bar is RED adjust the distance between the 2WIN and the patient in order to focus the image and to obtain a GREEN top bar. Try every time to focus as best as you can, looking at the corneal reflex.
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5. When the top bar is PERMANENTLY green and the focusing indicator reaches the highest peak (as shown in the following photo) release the BUTTON S1/S2. Examination screen – focus OK 6. Stay firmly in the condition in which the upper bar is green until the message DATA PROCESSING appears on the display.
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Wait until the measurement process is finished and the results of the measurement are displayed on the screen. A two-beep sound indicates that the measurement has been correctly taken (this is an option selectable from Measurement>Sound>Alerts>Ending Beep). • If the ambient light is too high a message will appear warning about the unsuitable condition.
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Possible anisocoria For any problem during operation, please refer to Chapter 21 - Troubleshooting. 7. At the end of the measurement the results are displayed: Measurement screen The results of the measurement are here described. The top box contains, for OD and OS respectively, the values for sphere and cylinder, the axis and the “reliability index”, a number between R1 to R9 (the higher the index, the more reliable the measure).
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PD = pupillary distance HT = inclination of the line connecting the centres of the two pupils, referred to the ground Axis angles are expressed according to TABO system. Numbers for “Pupil” and for “Gaze” represent, for OD and OS respectively, pupil diameters and horizontal and vertical (in this order) offset angles of the average position of the corneal reflex on respect of the centre of the detected pupil.
10.9 Zoom function When the measurement is performed, the operator can make a zoom on the acquired pupils of the patient. In order to do that SHORT PRESS the PRINT button. In order to come back to the main visualization just short press the power botton. The Zoom App has two main functions on the bottom left of the screen: the Zoom function (lens) and the Pan function (hand).
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If you hold the down button the zoom will became 1x, if you hold the up button the zoom will became 4x centered on the selected pupil. If you want to change pupil you have to press the right and the left buttons that allows you to choose on wich of the two pupils the zoom will take place.
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How to activate zoom on other measures You can use the Zoom App on an image took from another measure by selecting the Zoom function and loading the image. The Zoom App sometimes does not automatically identify the pupils. Auto-research of pupils In case of automatically identifying of the pupils, the situation will be the same as the nor- mal situation shown earlier.
After saving the two pupils positions you have to return to the main screen by pressing the power button and then you can save the exam and the pupils position by holding the print button. Once the new position has been saved you just need to reload the new exam from the SD memory to use the Zoom App again 10.10 Menu Through the menu it is possible to configure all the features and the working modes of the...
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The first level menu entries are described in the following paragraphs. • The submenu Measurement collects the settings related to the examination: • The submenu Display allows to change the way results are presented on the display. PLUS REFRACTIO CYLINDER MINUS CYLINDER DISPLAY...
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Volume: sets audio power output for the interactivity sound, within a range of four levels. Jingle: allows to choose the Jingle for the interactivity sound, out of three available melodies. Alerts: allows to activate the ending beep at the end of the measurement. •...
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• In the submenu Screening, 'ShowCurrentTable' displays the current Screening table, either the default table or the one compiled by the user. SCREEN DISPLAYED SCREEN MAX AXIS SCREEN MIN AXIS 'Update User Table' is selected when uploading a user table, and for uploading a newly compiled user table.
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Print screening on IRDA: enables/disables printing the full exam through IrDA to portable printer • The menu Settings configures three more features: Wireless (optional, this item is visible only in devices with the WiFi module installed) is described in Chapter 11. Date/Time: Date/Time Format allows to choose between H12 or H24 format.
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• The menu Functions configures three features: 2WIN APPLICATIONS 2WIN Applications: from this menu it is possible to set some Options for the available Applications. For more information refer to Chapter 20 – 2WIN Applications specific manuals. AUX: Auto test allows to make a self hardware test of the device. White Fielding will enable, on next measurement, a device verification test called white fielding.
Spherical Equivalent value will be displayed both in measurement mode and in browsing mode. 10.12 2WIN Anterior Segment Hint Anterior Segment Hint is an innovative A.I. based algorithm running on Adaptica Cloud, developed to give additional information to the user if 2WIN is not able to refract the patient.
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If the AI plugin logo is not followed by an asterisk, as in the picture above, it means that Anterior Segment Hint is active. When 2WIN is connecting to Adaptica Cloud the WiFi icon on 2WIN display turns into a cloud icon with two green arrows, as shown in the figure below: When 2WIN is correctly connected to Adaptica Cloud the cloud icon becomes steady blue, and a notification is displayed in Notification Center (see Paragraph 10.21):...
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If any error occurs during the connection to Adaptica Cloud or during the upload of the pu- pils images, the cloud icon changes to cloud error icon: When 2WIN is connected to the cloud, data collected during 2WIN exams are instantly processed by Anterior Segment Hint A.I.
WARNING: the message “Possible anomaly of the Anterior Segment” shall not be misunderstood as a diagnosis or a hint for diagnosis. For instance, a foreign object put in front of the eye during the exam could result is an anomaly of the eye profile not related to any pathology.
Possible configuration of the quick-menu. 10.14 Contextual Help At any time, holding the menu button, a help page is shown if the page provides one. Pages with the help option are: Main/Home, Menu, Keyboard, Age Selection, Browsing Mode, Data and Time Modification. Example of contextual help.
10.15 Summary of menu entries 1.0 Measurement 1.1 Display 1.1.1 Cylinder 1.1.1.1 Plus Cylinder 1.1.1.2 Minus Cylinder 1.1.2 Sphe. EQ 1.1.2.1 Spherical Equivalent 1.1.3 Gaze 1.1.3.1 Degrees 1.1.3.2 Hirschberg Test 1.2 Sound 1.2.1 Volume 1.2.1.1 Level 1 1.2.1.2 Level 2 1.2.1.3 Level 3 1.2.1.4 Level 4 1.2.2 Jingles...
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3.0 Settings 3.1 Wireless 3.1.1 Wireless ON 3.1.2 WiFi Status 3.1.3 WiFi Config 3.1.4 WiFi Options 3.1.4.1 2WIN Password 3.1.4.2 Auto Connect WiFi 3.1.5 Connections 3.1.5.1 VisionFit Connection 3.1.5.2 APP Connection 3.2 Bluetooth 3.2.1 Bluetooth ON 3.2.2 Bluetooth Status 3.2.3 Bluetooth Options 3.2.3.1 Set Bluetooth pin 3.3 Kaleidos 3.3.1 Kaleidos...
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4.3 Light Meter 5.0 Help 5.1 Show Help 5.2 About...
10.16 Print to portable infrared printers 2WIN is compatible with the following battery-operated printers: 1) Manufacturer GEBE – Model 11898 GPT-4378-Flash-79-V.24-IrDA Compatible with 2WIN software version greater than 4.1.161213 2) Manufacturer SEIKO – Model dpu-s_245 Compatible with 2WIN software version greater than 4.1.161213 3) Manufacturer ZEBRA –...
You can print the same exam as many times as needed. When printing to IrDA printer, the data transmission can be interrupted and aborted by keeping the BUTTON B pressed for 1 second. Please refer to Appendix B for the infrared printers configuration instructions. 10.17 Mail Printing It is possible to send a mail with 2WIN pdf attachment in order to allow mail printing from 2WIN or to receive via email the measurement.
10.18 Save exam If the SD card printing is inserted, a set of 4 files for each examination will be saved into the SD card, into the folder Patients (“2WIN Exams” if the software version is the 4.0 or more), there creating a subfolder named 2WINExam _date_number, where date is current date and number is a sequential number.
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Exam report in .pdf There are a limited number of prints before the machine starts rewriting oldest files. When printing, Printing: done” message will also show the internal memory total exam capacity (1000 patients).
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“Printing: done” message Printout sample from portable IrDA printer Data saved in the file Patient_date_number, with the different extensions listed above, can be extracted from the SD card by connecting the 2WIN to a PC by means of the USB cable supplied.
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Print screening on IRDA This option allows you to print a paper screening report. To activate it: Menu>Print>Options>Print screening on IRDA Strip in Pdf This option allows the creation of a strip similar to the IrDa strip in pdf format. It can be enabled from Menu>Print>Options>Strip in Pdf.
CVS Exporter Tool The 2WIN permits to export all the exams stored in the SD card in a CVS (Comma Separated Value) file. This text-based file can be used to share data from 2WIN and spreadsheet documents. Select “Export Patient” from Menu>Print Once activated the export patient, the 2WIN will create in the root of the SD memory card the CVS file with the following name-format: Resume_Date_Hour.
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In the images you can see the position of eye on maps, and you can easily understand how Tropia is evidenced simply comparing position in binocular (first line) respect a cover test (under). During cover test, the only eye the patient is using is fixating perfectly. On the binocular vision can happens that one eye is not fixating.
Hirschberg Test If “Hirschberg test” is selected for the representation of the gaze, either in the MENU or by toggling the visualization type via cross button (DOWN arrow), the results for patient's fixation will be expressed by the Hirschberg test coding: ET = esotropia EP = esophoria HT = ipertropia...
Custom RGB sequence By creating in the root folder of the SD card a file named rgbCustomSequence.txt and enabling custom sequences in the menu, the interactivity light can be personalized. The file shall contain 30 or less rows (exceeding rows will be ignored) coded as follows: each row contains 4 numbers •...
networking status and logins and notifications on the additional software Applications installed. When a new notification is added to Notification Center, 2WIN logo will be shown with a red background. The notifications are stored in the Notification Center in a recursively way, the last 20 information are always showed.
Cross button, push RIGHT or LEFT, UP or DOWN to switch between the list of age intervals, the 'Ok' button, and the 'Cancel' button. Cross button, push CENTRE button to save the selected interval, then choose 'Ok' or 'Cancel'. (NOTE: if the date of birth has been already inserted via the long left press, then the age interval is automatically set).
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Customization To insert a custom table (in order to follow regional or different rules compared to the AAPOS ones), a file 'screeningTable.txt' has to be written and inserted in the SD memory card. Data must be written in the first six lines of the file. Each line corresponds to an age interval (maximum six intervals).
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0 2.5 4.5 3.5 2 2.5 1 4.6 2.5 4 4 2 1 4.6 4 15 4 3 2 2 1 4.6 15 50 3.5 1.5 1.5 1.5 1 4.6 50 60 3.5 1.5 1.5 1.5 1 4.6 60 99 3.5 1.5 1.5 1.5 1 4.6 Upload Uploading a table: from the menu Screening, select 'Update User Table', a message indicates which table is uploaded (default or user) and if the table has been correctly loaded.
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NOTE: Screening Measurement Result is an Auxiliary window. Read the relative paragraph for more information.
It is possible to control remotely the 2WIN by means of an external 2WIN APP made by Adaptica running on Android smartphones and tablets; b) If the 2WIN is equipped with the KALEIDOS accessory, so forming the 2WIN-S, it is possible to control the 2WIN by means an external 2WIN APP made by Adaptica running on Android smartphones and tablets;...
NOTE: Bluetooth connectivity is enabled by default on the 2WIN. 11.2 WiFi connectivity 2WIN equipped with WiFi module (a label under the USB connection door identifies the presence of module) can be connected to a WiFi connection. d) It is possible to download and visualize patient data from the 2WIN to an external device (e.g.
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Android smartphone/tablet device or in a personal computer with Windows or MAC OS. f) It is possible to transmit some of the 2WIN results to the Adaptica VisionFit SC (you need a VisionFit SC connected to the same WiFi network of the 2WIN)
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2. Select the option “WiFi Config” and push the cross button to find the available networks. Select your favourite Wifi network, then push the cross button to make appear the network password insertion window. Insert the network Password, then select and push the button “Done”.
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(2) determine the IP address of 2WIN. WARNING! The default password of 2WIN for networking services (SFTP and VNC + SSH) is adaptica. The 2WIN password is a security key for the system. To change the password, go to “WiFi Option” and set the new security key.
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NOTE: For security reasons, it is recommended to change the password as the default one is common to all 2WIN.
Adaptica’s VisionFit SC is a mobile and wearable subjective refractor (phoropter) which can be used in combination with 2WIN or 2WIN-S. Once 2WIN (or 2WIN-S) are paired it is possible to transmit 2WIN (or 2WIN-S) objective refraction results to VisionFit SC in order to speed up the objective refraction measurement.
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4. From VisionFit SC tablet application enter Settings and select 2WIN Connection. The pairing between the two devices automatically starts.
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5. When the pairing is complete a green circle appears on 2WIN icon on VisionFit SC application. NOTE: pairing does not have a preferred sequence order (VisionFit SC - 2WIN). Pair- ing can also be performed in reverse order (2WIN-VisionFit SC).
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Pairing is needed only the first time. Pairing must be performed again only if you change devices (2WIN or VisionFit SC). To transfer a 2WIN/2WIN-S measurement to VisionFit SC follow the steps below: 1. Perform a test using 2WIN . Short press the down arrow button in /2WIN-S and save it 2WIN (or in 2WIN tablet application).
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Transferring an exam from 2WIN (or 2WIN-S) to VisionFit SC using Bluetooth connection The first time you want to transfer an exam to VisionFit SC you have to pair the devices. Follow these steps: 1. Enable Bluetooth on 2WIN from Menu > Settings > Bluetooth 2.
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4. When the pairing is complete a green circle appears on 2WIN icon on VisionFit SC application. NOTE: Pairing is needed only the first time. Pairing must be performed again only if you change devices (2WIN or VisionFit SC).
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To transfer a 2WIN/2WIN-S measurement to VisionFit SC follow the steps below: 1. Perform a test using 2WIN /2WIN-S and save it 2. Enter Reference area in VisionFit SC tablet application and tap on the 2WIN+ button. 3. 2WIN data will appear instantly on Reference area in VisionFit SC /2WIN-S application.
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Not available measurement from 2WIN can’t be transferred on VisionFit SC. Blue sphere on the right side of WiFi symbol indicates the connection with the VisionFit SC.
There must be a Micro SD card to view the content. Port: 22 *adaptica is the default password if not changed by user --- --- --- --- --- --- --- --- The VNC+SSH access to 2WIN is carried out with the following setting:...
Viewer *At the date of this manual review this Application is not free NOTE: Adaptica suggests the use of the above Applications/software for working with the SFTP and VNC + SSH services of the 2WIN. The specific (1) installation procedure, (2) use and (3) support of these Apps can be acquired reading the specific Apps user manuals.
3D, instead, is the older version and it is powered by a power bank. You can recognise if your 2WIN-S system is made of a KALEIDOS or a KALEIDOS 3D by checking KALEIDOS bottom. The following pictures show you how to distinguish between...
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KALEIDOS bottom and control panel KALEIDOS 3D bottom The following paragraphs describe the setup instructions for KALEIDOS and KALEIDOS 3D.
12.2 KALEIDOS: How to start WARNING! When 2WIN is used in 2WIN-S configuration, connected to the battery pack through the USB cable, 2WIN’s internal battery must be removed. To switch ON/OFF the system 1. Short press the switch-on/off button to switch the sys- tem on.
12.3 KALEIDOS 3D: How to start To switch ON/OFF the system 1. To switch the system on press the Switch-on/off button, then press the power button (power button stays white after startup). A beep sound stands for turning on the sys- tem.
2. When this option is turned on, the 2WIN must be used inside the KALEIDOS 3D system only. 3. The next configuration is to pair the 2WIN with its remote control APP (running on Android smartphone or tablet): enter the 2WIN Menu -> Settings -> Wireless -> Connections and enable the App Connection by clicking on it, like in the following picture.
12.5 KALEIDOS packing list The box contains (default configuration): • the electronic version of the operating manual (inside the microSD) • the 2WIN device inside KALEIDOS • two rechargeable batteries (one already inside the 2WIN) • a microSD memory card with SD Adapter •...
2WIN App functioning. 13.1 2WIN App installation and configuration In order to use the 2WIN App, either for 2WIN-S or 2WIN remote control, the device and the Application must be paired for the first time. Please follow these configuration instructions to pair 2WIN-S and the tablet Application: 1.
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5. The following window Appears on 2WIN’s display: 6. From the tablet Application open the Settings panel and select 2WIN Connection...
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7. The following window appears on the tablet Application:...
8. Press button number 2 on KALEIDOS control panel until the LED becomes blue. Then release the button. 9. If the pairing succeeds LED number 2 on KALEIDOS control panel becomes green and 2WIN icon on the tablet Application becomes green as well. NOTE: to use the remote Application to control 2WIN follow the pairing instructions from step 1 to step 6.
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On the left side of the 2WIN App there are all the status icons and settings of the App. Note that the icon representing the 2WIN must contain a GREEN dot. If this is not present even if the 2WIN and tablet are connected and paired correctly, please tap on the 2WIN icon.
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4. The report is saved in the EXAM folder. Open the folder tapping on the folder icon. Live Mode Function When used in KALEIDOS mode, the BUTTON D (see Paragraph 8.6 - Interfaces) has a different function: short pressing BUTTON D a live mode visualization starts and it is possi- ble to see the live of the video, looking at the pupils.
KALEIDOS App functioning. 14.1 KALEIDOS App installation and configuration In order to use the KALEIDOS App for 2WIN-S remote control, the device and the Applica- tion must be paired for the first time. WARNING: KALEIDOS App is compatible with 2WIN-S having software ver- sion 5.4.2 or higher and hardware version 29.1 or higher.
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5. Tap on the Bluetooth icon on the KALEIDOS App to start available Bluetooth de- vices search. A window showing all the available 2WIN-S will open. 6. Connect to the desired 2WIN-S. When the pairing is complete a confirmation mes- sage will appear.
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. 14.2 Refraction exams using KALEIDOS App To take an exam using KALEIDOS App follow these steps: 1.
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3. Once the data are set press the START button. The measurement starts and a progress bar is displayed:...
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4. During the measurement the patient’s pupils are circled in green. If the patient’s pupils are circled in red the measurement is not correct and shall be repeated. Pupil diameters are displayed below the eyes image during the measurement phase. The graph on the bottom of the window is the focusing meter, maximizing the value of the graph will lead to a better measurement.
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6. Press on the Image button on the top right of the results window to visualize the patient’s eyes and pupils images:...
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7. To see the screening results press on Info button of the top right of the results window:...
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8. Tap on the PDF icon below the screening results table to generate the PDF report of the exam. As alternative, you can create the PDF report tapping on the PDF icon on measurement results window. 9. To save the measurement press Save button on the dropdown menu that appears clicking on the three dots on the top right of the results window.
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NOTE: Pressing the Save button the exam is automatically saved both in the tablet and in the 2WIN’s microSD card. The PDF report is saved only in the tablet. If you don’t want to save the measurement just exit the Application or go back to the Home window to start a new measurement.
To work properly, Anterior Segment Hint needs the tablet to be connected to a WiFi network having internet access. If Anterior Segment Hint is enabled on your 2WIN-S and if the tablet is connected to a WiFi network having internet access, the cloud icon on KALEIDOS App is blue, as shown in the...
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Data collected during the 2WIN (Refraction) exam are instantly processed by Anterior Seg- ment Hint A.I. algorithm. When the exam is processed, the cloud icon on Measurement result window turns from blue to green.
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If 2WIN-S is not able to refract the patient and any suspect anomaly of the anterior segment is detected, the warning “Possible anomaly of the Anterior Segment” is given to the operator with the indication of the eye (left, right or both).
14.4 CR exams using KALEIDOS App From KALEIDOS App it is possible to select Corneal Reflexes (CR) measurement mode. CR measurement mode provides information regarding the corneal reflexes position, giving hints about possible phorias and tropias. CR measurement mode is already active if you are using a KALEIDOS Plus. Otherwise, it requires an activation code.
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“Measurement Mode” dialogue window appears. Select the desire mode and press SAVE button. When Corneal Reflexes mode is selected the Application icon in the home page of KALEIDOS App changes and displays CR icon.
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NOTE: Default mode is 2WIN (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, one monocular covering the Left eye, the other monocular covering the Right eye. The patient must gaze at the white LED that turns on during the measurement.
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4. Corneal Reflexes measurement window opens. 5. Ask the patient to look inside the 2WIN-S and gaze at the white light. Press on one of the pause buttons to start the corresponding measurement. You can perform the three measurements in any order.
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6. When all the needed measurements are completed the button RESULTS appears. Tap on the button to see the patient’s pupils shots and the exam results. NOTE: You can repeat each measurement as many times as you want, just tapping on the corresponding button.
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7. In CR Measurement Result window the patient’s pupils, acquired in the three measurements, are displayed. Next to the pupils the result of the cover test is reported. Please refer to the following paragraph for the interpretation of CR Measurement results. 8.
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NOTE: When you perform any of the monocular measurements use the IR occluder provided by Adaptica (NOT OTHER OCCLUDERS) to cover the contralateral eye. Follow these instructions for the correct IR occluder positioning: o Hold the occluder in a vertical position and with the handle downwards...
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CR Exam Results In the CR Measurement Result window three pairs of pupil images are displayed. The images represent from top to bottom: Both eyes open Right eye open, Left eye covered Right eye covered, Left eye open NOTE: The covered eye is highlighted by a grey square. From the pupil images it is possible to identify the position of the corneal reflexes with respect to the pupillary geometrical center.
The default output shows also a value for the k angle: Horizontal k angle (labelled as 'kx'): the output is '+' when the corneal reflex lays nasal to the center of the pupil, '0' when the corneal reflex coincides with the geometrical center of the pupil, '-' when the corneal reflex is on the temporal side.
In GENERAL tab the following information are displayed: Status: WiFi status, Battery status, Kaleidos mode Version: 2WIN’s software version, 2WIN’s hardware version, 2WIN BT protocol version, 2WIN’s serial number System: the button SHUT DOWN allows you to switch the 2WIN-S off...
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WI-FI STATUS From WI-FI STATUS tab it is possible to get information about 2WIN’s WiFi connection: WiFi status WiFi strength Network name Network IP Network type...
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WI-FI CONNECT From WI-FI CONNECT tab it is possible to scan for the available WiFi networks and to connect to a WiFi network:...
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CUSTOMIZATION From CUSTOMIZATION tab it is possible to customize the PDF report footer and to set up the EMR connection. In order to customize the PDF report, you can edit up to three custom lines. These lines will be added to the report’s footer. In order to set up the EMR connection, please refer to Paragraph 14.7.
14.7 EMR connection setup EMR connection feature allows to import patient data from an EMR system to the KALEIDOS App and to send automatically the exam results from the KALEIDOS App back to the EMR system. EMR connection feature is already active if you are using a KALEIDOS Plus. Otherwise, it requires an activation code.
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4. In the Shared Folder section, set the following values: o Server IP: the EMR system PC’s IP address o Share name: the name of the Shared Folder to be paired to the current 2WIN-S o Username: a network user having read/write permissions on the Shared Folder o Password: the password for the selected user.
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Once a CSV input file is provided, the manual entry of patient data in the KALEIDOS App user interface is disabled. You can manage multiple 2WIN-S on the same EMR system. Different 2WIN-S devices work on different Shared Folders, so you must create a dedicated Shared...
Send an e-mail for an Application request with the serial number of your 2WIN. The complete list of 2WIN software Applications at www.adaptica.com. A file will be sent to you by mail; copy this file in the root of your SD card. After copying, restart the 2WIN.
The main Application is the displayed one that appears in the main visualization at the end of the measurement. When you don’t use the default Application for refraction measurement, the main measure window is blue coloured. 15.4 Auxiliary Windows From Main Screen of 2WIN, push right the CROSS button to display the Auxiliary window (default is screening result).
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There are two sets of icons: regular ones and green ones. The latter are options of the 2WIN that, if enable, permit to the instrument to add some special functionality. E.g. the App Connection icon (green icon) means that in that particular 2WIN is enabled the communication with a controlling APP in an external Android Tablet/Smartphone.
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If the user tries to activate a specific 2WIN App that have the *-symbol, the 2WIN shows a warning message like the next figure. The message suggests the user to send an email to the contact address of Adaptica: contact@adaptica.com in order to purchase the specific Application.
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“Measurement Type” dialogue window appears. Select the desire mode and press SAVE button. When a particular mode is selected the Application icon in the home page of 2WIN BT APP changes and displays the icon on the selected mode. NOTE: Default mode is 2WIN mode. When 2WIN BT APP is restarted 2WIN mode is loaded.
ATTENTION: the operator is not allowed to perform a DOWNGRADE of the 2WIN software. Adaptica is not responsible for the improper use of the device with a downgraded software version. ATTENTION: when the software update procedure will be performed, the 2WIN battery must be fully charged.
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Note: make sure that the microSD card is inside the 2WIN, and that the 2WIN is not connected to any PC with USB cable before proceeding. If you decline the update pressing CANCEL the message will disappear until next update check, if you want to update your 2WIN press OK button, and the software download will start.
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(the update will take place at next 2WIN reboot). System update will start at next startup. If the 2WIN is in 2WIN-S configuration, inside a KALEIDOS accessory, after the system update, the 2WIN will restart again for the KALEIDOS firmware update.
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Note: 2WIN after firmware upgrade may reboot one or two times, depending from the firmware version.
18 Disinfection When using the KALEIDOS accessory, in the 2WIN-S configuration, it is necessary to disinfect the area where the face of the patient will contact the device, before any change of patient. Disinfection should be achieved by means of single-use disinfecting pads, such as individ-...
19 Maintenance and cleaning instructions No maintenance operations are required by the system. If the measurement never ends correctly and the hardware test does not reveal any hardware problem, the system may be periodically verified, by means of a procedure called “white fielding”.
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local public administration, or in alternative an authorized company can recycle the WEEE. Please refer to public administration about the separate collection, if this information is not available, contact the manufacturer of the equipment. 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.
20 2WIN Applications specific manuals 20.1 Legend of symbols Warning: necessary information for safety Important information 20.2 2WIN Applications installation To install 2WIN Applications follow these steps (which are the same for every Application): Connect the 2WIN, with MicroSD plugged in, to your computer with the USB cable; NOTE: if 2WIN is turned off, wait till it turns ON automatically once connected to USB cable.
20.3 Analysis of Corneal Reflexes Position (CR-App) This function provides information regarding the corneal reflexes position, giving hints about possible phorias and tropias. CR-App feature allows to collect data from 3 measurements and to analyze the corneal reflexes. Results are expressed either in prism diopters or in degrees. Corneal Reflexes App activation After the installation this App must be activated to be utilized.
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Corneal Reflexes exam Tips for the patient Patient must gaze the White led that turns on during measurement with ‘Corneal Reflexes’. Exam procedure The procedure is the same as refraction measurements (the single binocular and monocular acquisitions are much faster as the Application is dedicated to eye alignment and not to refraction measurement) Use the top bar that gives feedback on the conditions for measurement: in particular, this bar becomes red or green.
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2. Press and hold BUTTON S1 or S2, in order to start the measurement. 3. Center the eye/s of the patient in the display live area, inside the blue rectangle (measurement area) – the message “FOCUSING” will appear. Examination screen – bad focus 4.
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Green Indicator 7. Click the BUTTON C ( ) and select the eye where you want to perform the cover test, using the Binocular Occluder provided by Adaptica (NOT OTHER OCCLUDERS) to cover the contralateral eye.
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Cover OD 8. Repeat the steps 1 to 6 to get the measurement. Click the BUTTON C ( ) and repeat the procedure on the other eye, moving the eye occluder onto the contralateral eye. Cover OS 10. Repeat the steps 1 to 6 to get the measurement. Exam Results from ‘Corneal Reflexes’...
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The images represent from top to bottom: both eyes open right eye open, left eye covered right eye covered, left eye open The covered eye is highlighted by a light blue square. The cloud of points in each image graphically reports each individual corneal reflex collected during the exam.
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The default output shows the following: Horizontal k angle (labelled as 'kx'): the output is '+' when the corneal reflex lays nasal to the centre of the pupil, '0' when the corneal reflex coincides with the geometrical centre of the pupil, '-' when the corneal reflex is on the temporal side. Vertical k angle (labelled as 'ky'): the output is 'S/D' when the corneal reflex of the left eye lays superior to the corneal reflex of the right eye, 'D/S' in the opposite case.
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An example of Corneal Exam Report (PDF) In the printout the results are displayed in degrees or prism diopters, the concentric circles representing 10 units steps of that unit (10, 20, 30 Prism diopters or degrees). The pupil is sized accordingly and cropped if bigger that 7 mm. In the report is also possible to see all the pupil pictures.
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Reset in Corneal Reflexes New measurement overwrites old data with new data automatically.
20.4 Dynamic Pupillometry Application (DP-App) This function provides information regarding the pupils response (diameter during time) when the eyes of the patient are stimulated with a known visible and programmable white light created by the 2WIN. The visible stimulus light can be programmed by the operator in intensity and duration. Results are expressed in a graphical image showing the pupil response to the visible stimulus and through some parameters showing the estimation of pupil response time, reaction time and slopes of the changes of diameter versus time.
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1) Default mode: This mode makes a first calibration of the eye response values taking into account also the ambient illumination 2) Manual mode: the operator can configure manually the set of visible light stimuli. The duration of each stimulus lasts minimum 2 seconds. For configuring this mode, the operator has to write a TEXT file in a normal text editor in a computer ad save that file in the SD memory of the 2WIN.
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When you released the S1/S2 button till the exam automatically finish (after 14 seconds). Standard mode The standard mode is activated in the Dynamic Pupillometry Applications only if the right configuration file is not present in the 2WIN SD card or if this file is corrupted. The standard mode creates (after a dark second) a sequence of 4 bright light impulses.
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Example configuration file This file creates the following sequences of exam phases: • Phase1 = dark condition (no visible illumination), 2 seconds • Phase2 = 8% of the maximum visible light is turned on, 2 seconds • Phase3 = dark condition, 2 seconds •...
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• T = is the minimum pupil diameter limit threshold. If during the 4 calibrating intensities of light the pupil diameter of any patient pupil goes under this value, then during the last and final measurement phase the 2WIN will use the corresponding light intensity that caused that specific threshold crossing.
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NOTE: in the case T value is missing in the configuration file, then the standard mode will be used by the 2WIN. On the other hand if any of the other numerical values (P,A,B,C,D) are missed in the configuration file (or written in the wrong format), then 2WIN will use the calibration mode with a default sequence of: T=4, P=10, A=8, B=16, C=32, D=64.
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Browsing mode It’s possible to load a previously saved Dynamic Pupillometry exam: long push on the DOWN button of the 2WIN joystick. Then the operator can read/browse the previous exams by pushing the UP or DOWN button. Then, the main window of the 2WIN will display in the upper part the maximum and minimum pupil diameter for each OD and OS.
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NOTE: if the Application is in the DEFAUL or CALIBRATION mode, 2WIN will recognize automatically the calibration pulses. In this case it will be possible to measure only the last pulse (not calibration one). NOTE: if the Application is in MANUAL mode, 2WIN permits to measure all the single pulses but in the final PDF report data will be saved only referring to the first valid impulse.
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When the second axis (line) is positioned, automatically the response time of the pupil (in seconds) will appear in the lower part of the display of the auxiliary window of the 2WIN. On the next pressing of the MENU button the selected (and editable) line will be the third, show- ing the exact time the pupil response finishes to react to the light illumination impulse.
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if it is related to a decrease in the pupil diameter, while it will be black if it is related to an increase. If the operator presses again the MENU button, all the lines will become yellow (it means you have finished positioning them). By pressing the right or left button of the joystick it will be possible to switch side of the light stimulation exam (from the descending to the as- cending side) and repeat the axes positioning for that side.
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pupil responses lines. This action will store temporarily all the examination in the 2WIN memory. If all the change event were discovered, in order to store permanently the exam in the 2WIN SD card, the operator must come to the 2WIN home screen pressing the ESC button, and then press and hold the PRINT button (this will generate the final PDF report of the exam).
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3. VoD = Velocity of Dilation, which is the pupil velocity to dilate. DIFF: it’s the difference between the right and left eye. It also reports which of the two values is greater.
20.5 Lens Centering Application (LC-App) Lens Centering Application allows to obtain all the parameters needed for new glasses centering or to check if current glasses centering is correct. During Lens Centering measurement the patient must wear glasses. Lens Centering Application activating To activate Lens Centering Application you have to press the Button A, and select the right Application by moving by the arrows of the joystick.
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After the measurement is done, the main PD information is displayed at the top of the Application’s main display. Browsing mode To activate Lens Centering App in a measurement already saved you have to enter in the browsing mode by holding the down button of the joystick till the loading of the exam history.
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When the exams have been loaded you can browse them by the down and up button of the joystick and select the exam you want. Exam results After you have accomplished the measurement you can observe the Lens Centering by clicking the right button, it will take you to the main screen of the Application.
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If the Pupil Distance is not valid, the LC App shows a warning message because has no referring for high precision measure. Using the LC App in this mode, will result low precision measure. Navigation You can select the axis you want to move by pressing the central button of the joystick, it will highlight red the axis allowing the changes.
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How to position the vertical axes The positioning of vertical axes can be done by left and right button of the joystick that will move the axes along the horizontal axis between the pupils. The central axis will be automatically located between the two movable axes. Centering values You can see the main values written directly on the top of the screen and the auxiliary data written on the bottom of the screen.
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Data displayed on the image are: • Semi inter-pupillary distance measuring, located on the top of the image. They represent the measures between the center of the optic axis and the central vertical axis. Divided to the left and to the right in correspondence to the side they will measure. •...
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Exam Report The PDF Report is composed of the lens centering graphic and the corresponding data. The image represents the axes graphic previously positioned. The report is divided in right and left eye, the values expressed for each eye represent: •...
20.6 Intermediate Vision Application (66cm-App) Thanks to Intermediate Vision Application 2WIN is able to measure the patient’s refraction while reading at the distance of 66 cm (24”). In all those cases when reading at such dis- tance proves difficult, the 2WIN calculates the necessary additional power (ADD) to re- store best vision.
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2WIN Applications screen Main Visualization – Intermediate Vision Intermediate Vision Exam Tips • Intermediate Vision test must be realized asking the patient to wear usual glasses (if typically used) or contact lenses -not reading glasses. • Before the measurement please make sure “Intermediate Vision Application” is activated (check the icon .66 on the bottom of the display).
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• Unstable (environmental) conditions may provoke accomodation for patient. This reduces reliability index for measurement. In case of unstable measurement the following warning message will appear on the display: • The operator must apply the chart and the lens on the front side of the 2WIN into the central aperture).
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Environment setup It is important to prepare the correct environment for the examination. Please use an appropriate lamp following these tricks: • Place the light source behind the patient, out of the FOV (field of view) of the 2WIN. Otherwise, measurement could be unstable and have low index of reliability. With such conditions a warning “Ambient light too bright”...
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Exam Procedure 1. Apply the add-on lens and the Reading chart on the front side of the 2WIN. Pay attention not to cover 2WIN frontal LEDs: with a wrong chart positioning measurement may not be possible. 2. Turn the 2WIN on by pressing the BUTTON A 3.
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4. Ask the patient to wear glasses if typically worn (distance-vision glasses) or contact lenses, not reading glasses. If patient wears progressive glasses, ask the patient to look the chart through the top-side part of the lenses. 5. Ask the patient to focus central characters of the chart (the letters near to the central lens).
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The topside value represents the Measurement range additional spherical equivalent. power (ADD) is within the value range 0 D – 3.25 D. It is the estimation of the necessary additional power (ADD) to restore Out of this range the output is n.a., with best vision (spherical equivalent = the indication of Myopia or Hyperopia;...
20.7 Eye Morphology Application Eye Morphology Application measures different distances in the eye. This kind of measurements is very useful in determining some key parameters of the so-called Fetal Alcohol Syndrome (FAS). It allows to identify eye width with no care about pupil position. Eye Morphology Application activation To install Eye Morphology version 2.0 the operator needs to place an activation code in the 2WIN SD card (follow the same procedure to install any other 2WIN Apps, but Eye...
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Eye Morphology measure To change eye selection use MENU_LEFT and MENU_RIGHT keys. MENU_UP and MENU_DOWN buttons change zoom value: to get Eye Morphology measure, the minimum zoom factor is 2.8x. It is possible to change eye and zoom when no axes are selected/active (all axes are blue).
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Exam Results Eye Morphology feature extracts three parameters for each eye: EM = vertical axes distance in millimetres P2L = distance in millimetres from left vertical axis to pupil centre P2R = distance in millimetres from right vertical axis to pupil centre...
Switch on the wifi and activate wifi needed. connect the 2WIN to the connection case connection available for the 2WIN, connect to http://www.adaptica.com/ 2WINCALIBRATION/ with your laptop and follow the instruction. For the manual update, please visit Settings update Connect http://www.adaptica.com/2WINCALI needed.
22 Additional information 22.1 Technical specifications Measuring range for spherical defect: -15,00D +15,00D Measurement precision for spherical defect: +/- 0,25 D Measuring range for cylindrical defect: -5,00D +5,00D Measurement precision for cylindrical defect: +/- 0,25 D Measuring range for cylinder axis: 1 – 180 degrees, step 1 degree Measurement precision for cylinder axis: +/- 5 degrees Measuring range for pupil diameter: 4 –...
NOTE: when the “Remote Control” is enabled and used it will not possible to make access to the SD card of 2WIN, the instrument must be rebooted in order to do that. Telemetry 2WIN telemetry service is used from Adaptica in order to get information on the status of the 2WIN. (See APPENDIX A).
Adaptica S.r.l. and will neither be acquired nor treated by it, it is however advisable to remove the SD card or delete any sensitive data before such activation, in order to avoid the transfer of the same data.
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Telemetry Data and the Remote Control Data will make the use of the 2WIN instrument impossible to the same. The autonomous owner (“titolare autonomo”) of the Telemetry Data and the Remote Control Data is Adaptica S.r.l., a company with its registered office in Padua, Via San Marco 9/H.
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Appendix B – How to configure the infrared printers This Appendix describes how to manually configure the following IR printers: • Manufacturer GEBE – Model 11898 GPT-4378-Flash-79-V.24-IrDA Compatible with 2WIN software version greater than 4.1.161213 Instructions for proper configuration of the printer in order to accept 2WIN data (via infrared) The printer is preset with the following configuration: •...
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Adaptica nor any 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.
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Example: Smith,John,2016-02-24,1234567890,Downtown Clinic,johnsmith@e-mail.com is a valid input file • 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,,, 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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