Adaptica 2WIN User manual

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2WIN
OPERATOR MANUAL

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Revision notes
Software configuration version
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

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Summary
REVISION NOTES...............................................................................................................................................................................................................................2
GENERAL NOTES...............................................................................................................................................................................................................................2
1MANUFACTURER IDENTIFICATION ........................................................................................................................................................................................5
2LEGEND OF SYMBOLS ...........................................................................................................................................................................................................5
3INTENDED USE OF THE DEVICE..............................................................................................................................................................................................6
4CLASSIFICATION AND APPLIED STANDARDS ..........................................................................................................................................................................6
CLASSIFICATION ACCORDING MDD 93/42/EEC, ANNEX IX, AND MDR 2017/745 EU, ANNEX VIII................................................6
IP CLASSIFICATION............................................................................................................................................................... 6
ELECTROMAGNETIC COMPATIBILITY ........................................................................................................................................6
APPLIED STANDARDS............................................................................................................................................................6
5PRECAUTIONS......................................................................................................................................................................................................................7
6QUICK USER GUIDE ..............................................................................................................................................................................................................9
6.1 IMPORTANT................................................................................................................................................................9
6.2 MAIN APPLICATIONS ....................................................................................................................................................9
6.3 EXAM CONDITIONS.....................................................................................................................................................10
6.5 MEASUREMENT TIPS...................................................................................................................................................10
7DESCRIPTION OF THE DEVICE.............................................................................................................................................................................................. 11
7.1 2WIN.....................................................................................................................................................................11
7.2 LABELS.....................................................................................................................................................................12
7.3 PACKAGE LABELING ....................................................................................................................................................13
7.4 INTERFACES ..............................................................................................................................................................14
7.5 GRAPHICAL USER INTERFACE ........................................................................................................................................16
8OPERATIVE INFORMATION................................................................................................................................................................................................. 17
8.1 OPERATING CONDITIONS .............................................................................................................................................17
8.2 UNPACKING..............................................................................................................................................................17
8.3 INSERT BATTERY.........................................................................................................................................................17
8.4 EXTRACT BATTERY......................................................................................................................................................18
8.5 BATTERY-CHARGING................................................................................................................................................... 18
8.6 BEFORE OPERATION ...................................................................................................................................................19
8.7 DATA MANAGEMENT DISCLAIMER .................................................................................................................................19
8.8 SOFTWARE LANGUAGE................................................................................................................................................19
9OPERATIVE INSTRUCTIONS................................................................................................................................................................................................. 20
9.1 ENVIRONMENT SETUP................................................................................................................................................. 20
9.2 DEVICE SETUP ........................................................................................................................................................... 21
9.3 PREPARATION OF THE PATIENT .....................................................................................................................................23
9.4 MEASUREMENT......................................................................................................................................................... 23
9.5 BROWSING MODE .....................................................................................................................................................26
9.6 ZOOM FUNCTION.......................................................................................................................................................27
9.7 MENU .....................................................................................................................................................................29
9.8 SPHERICAL EQUIVALENT..............................................................................................................................................32
9.9 QUICK MENU............................................................................................................................................................32
9.10 CONTEXTUAL HELP...................................................................................................................................................32
9.11 SAVE EXAM............................................................................................................................................................. 33

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9.12 PRINT TO PORTABLE PRINTER...................................................................................................................................... 34
9.13 MAIL PRINTING.......................................................................................................................................................36
9.14 GAZE.....................................................................................................................................................................36
9.15 CUSTOMIZATION .....................................................................................................................................................37
9.16 NOTIFICATION CENTER..............................................................................................................................................38
9.17 AGE SELECTION .......................................................................................................................................................38
9.18 SCREENING TABLE....................................................................................................................................................39
10 WIRELESS CONNECTIONS.................................................................................................................................................................................................... 40
10.1 BLUETOOTH CONNECTIVITY........................................................................................................................................ 40
10.2 WI-FI CONNECTIVITY ................................................................................................................................................40
10.3 PAIRING AND TRANSFERRING A 2WIN EXAM TO VISIONFIT SC ......................................................................................... 41
11 REMOTE CONTROL: 2WIN APP-CONNECTION WI-FI ............................................................................................................................................................. 47
12 APPLICATIONS ................................................................................................................................................................................................................... 47
13 SOFTWARE UPDATE INSTRUCTIONS.................................................................................................................................................................................... 47
13.1 MANUAL UPDATE PROCEDURE....................................................................................................................................47
13.2 AUTOMATIC UPDATE PROCEDURE................................................................................................................................47
14 MAINTENANCE AND CLEANING INSTRUCTIONS................................................................................................................................................................... 48
14.1 HOW TO CLEAN THE SYSTEM ...................................................................................................................................... 49
14.2 STORAGE INSTRUCTIONS............................................................................................................................................49
14.3 INSTRUCTIONS FOR THE CORRECT DISPOSAL OF THE DEVICE...............................................................................................49
14.4 INSTRUCTIONS FOR THE CORRECT DISPOSAL OF 2WIN’S PACKAGING ..................................................................................49
14.5 SEPARATE COLLECTION FOR ELECTRICAL AND ELECTRONIC EQUIPMENT................................................................................49
15 TROUBLESHOOTING ........................................................................................................................................................................................................... 50
16 ADDITIONAL INFORMATION............................................................................................................................................................................................... 51
16.1 TECHNICAL SPECIFICATIONS........................................................................................................................................51
16.2 2WIN RECHARGEABLE BATTERY SPECIFICATIONS............................................................................................................51
16.3 WI-FI MODULES /BLUETOOTH ADAPTERS ....................................................................................................................51
16.4 OTHER SPECIFICATIONS .............................................................................................................................................52
16.5 DEVICE WARRANTY .................................................................................................................................................. 52
INFORMATION FOR ASSISTANCE ..................................................................................................................................................................................................... 53
NOTE FOR SERVICE PERSONNEL ONLY ....................................................................................................................................53
REMOTE CONTROL ............................................................................................................................................................ 53
TELEMETRY......................................................................................................................................................................53
APPENDIX A –DATA MANAGEMENT DISCLAIMER............................................................................................................................................................................ 54

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1Manufacturer identification
Manufacturer
Adaptica S.r.l.
Address
Via San Marco, 9/H
35129 Padova (PD) Italy
Telephone
[phone]
Mail
[e-mail]
Web
www.adaptica.com
2Legend 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
Warning: necessary information for safety
Important information
Read user manual before use

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3Intended use of the device
Instrument for the measurement of binocular and monocular refraction based on infrared (IR)
photorefraction.
4Classification and Applied Standards
Classification according MDD 93/42/EEC, Annex IX,
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).
Electromagnetic compatibility
This device has been classified as class B according to the standard IEC 60601-1-2.
Applied standards
EN 60601-1; EN 60601-1-2; EN ISO 15004.

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5Precautions
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. This instrument
generates, uses and can radiate radio frequency energies and, if not installed and used in accordance with
these instructions, may cause harmful interference to other devices in the vicinity. However, there is no
guarantee that interference will not occur in a particular installation. If the system does cause harmful
interference to other devices, which can be determined by turning the system off and on, try to eliminate
the interference by adopting one or more of the following measures:
•reorient and/or relocate the receiving device
•increase the distance between the devices
•In case of charging of the device, connect the system to an outlet on a different circuit than that to
which the other devices are connected
•consult the manufacturer or field service technician for help
This equipment has been verified to comply with the limits for a class B computing device, pursuant
to FCC Rules. In order to maintain compliance with FCC regulations, shielded cables must be used with
this equipment. Operation with non-approved equipment or unshielded cables is likely to result in
interference to radio and TV reception. The user is cautioned that changes and modifications made to the
equipment without the approval of manufacturer could void the user’s authority to operate this equipment.
Portable and mobile RF communications equipment, such as cell phones, can affect medical electrical
equipment: any 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.
The device must NOT be used in oxygen rich environments or in presence of flammable products.
The device must not be installed in a room exposed to chemical-physical aggressive agents (such as
sulphides, salt, dust, etc.), nor exposed to direct sunlight or lack of ventilation, high humidity, sudden
surges or drops in temperature. The safety and efficiency of the instrument are not guaranteed under these
conditions.
This device is designed to be used indoor. Do not expose the device to water: this could lead to fire or
electric shock.
This device is not to be used during a flight.

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Light radiation
The light emitted from this instrument is potentially hazardous. The longer the duration of exposure,
the greater the risk of ocular damage. Exposure to light from this instrument when operated at
maximum intensity will exceed the safety guideline after 30 minutes.
Do not stare at the light sources of the device from a distance lower than 1 m.
Precautions and general warnings
The clinical interpretation of the data provided by the device is restricted to licensed eye-care
practitioners.
The process of making a diagnosis using the device results is the responsibility of the eye-care practitioner.
A device specific training is required for any operator to become able to use the system.
For the correct use of the device, it is mandatory to carefully read the instructions in Chapter 8 - Operative
information.
Do not open the device: this could lead to electric shocks or damage to the system. No modification
of this equipment is allowed. Do not use the instrument if the cover or other parts of the device have
been removed.
Only technicians authorized by the Manufacturer may service the device. The Manufacturer cannot be held
responsible for system safety should the device be opened, repairs carried out, third party’s software be
installed, or parts be replaced by unauthorized persons.
Do not use the device while it is attached to the wall adapter for charging the battery.
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).
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.
The device needs to be operated in a semi dark room, in order to help pupil dilation.

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6Quick user guide
6.1 Important
•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.
•Working in natural binocular conditions, the 2WIN allows to evaluate simultaneously not only
refractive errors, but also gaze direction, ocular alignment, pupil diameter, pupil distance, and the
accommodative balance/unbalance between the 2 eyes.
•Please familiarize yourself with the measurement conditions and techniques of the 2WIN in order to
exploit its full potential.
6.2 Main Applications
•The 2WIN is a portable binocular vision analyzer. It detects a patient’s real-time refraction.
•It is a binocular instrument that measures refraction on the basis of eccentric InfraRed photo-
refraction (also photo-retinoscopy). Both eyes are measured at the same time, while fixating at 1
meter.
•It is battery operated, non-invasive, fast, and easy to use.
•It automatically measures binocular refraction, pupil distance, pupil size, direction of gaze, and
fixation abnormalities.
•Binocular refraction of infants and children from 6 months of age, seniors, impaired and non-
cooperative patients.
•Early detection and documentation of multiple amblyogenic factors.
•Over-refraction of glasses or contact lenses.
•OPTIONAL (APPs):
•CR-App: phoria/tropia measurements;
•DP-App: dynamic pupils’ response time and size caused by artificial light created by 2WIN;
•LC-App: centering of the visual axis on the glasses frame;
•66cm-App: addition power measurement at 66 cm distance from the patient (for visual
display unit, VDU).

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6.3 Exam conditions
With reference to electromagnetic compatibility, the device is designed for use in a professional
healthcare facility environment.
•The patient shall sit comfortably in a suitable exam room; infants should sit in adult’s lap. A uniform
dim light environment is necessary.
•The 2WIN accuracy is affected by external sources of light, in particular hot lights’halogen or
incandescent lamps because of the presence of high infrared content of the light; make sure no direct
light hits the patient’s face and ensure uniform light on both eyes.
•A stable measurement distance of 1 meter shall be maintained.
6.5 Measurement tips
•For sphere and cylinder, measurement precision is ±0.25 D or ±0.50 D depending on the range.
The cylinder axis is calculated between 1° and 180° (step 1°) with precision of ±5°. For high refractive
errors (above +7 D and below -7 D), the 2WIN displays “high M”(myopia) or “high H”(hyperopia) in
the upper part of the display. 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.”(Not Accessible measurement). For big refractive errors, in the case 2WIN succeeds to
estimate the spherical power only, this estimation will appear in the upper part of the display. This
maximum spherical estimation is between ±15 D. Refer to Section 15.1 for further information.
•Make sure the cylinder notation (minus or plus) is set to your preference.
•During the measurement, make sure that both eyes appear within the GraphicalUser Interface (GUI);
if necessary, slightly tilt the 2WIN.
•To refract infants, children, and non-cooperative patients, you can turn ON the audible and/or visible
fixation targets. Audio fixation (attraction system) is preferable to the visible lights fixation.
•Make sure the Reliability Index of the measurement is higher than 6 (max. is 9). In case it’s lower
than 6 a message with a hint will be displayed, for the repetition of the measurement.
•For accurate over-refraction with glasses, make sure that no light reflexes disturb the pupil detection;
should such reflexes be present, please slightly tilt the glasses down.
•Remember that free space, non-cycloplegic refraction can vary depending on several conditions
pertaining to the binocular visual function; in some specific patients, including accommodating
children, the 2WIN measurements may vary.

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7Description of the device
7.1 2WIN
The measuring principle of 2WIN 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. The spherical refraction is
calculated based on this crescent pattern. Cylinder and axis measurements are based on the same kind of
calculation, repeated on four meridians.
2WIN performs the measurement 1 meter (3 feet 3 inches) away from the patient (contact-less), with
continuous tracking of the corneal reflex, for the analysis of the binocular alignment, and with sensors to
check the measurement distance.
2WIN 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 good environmental conditions. Outside the 4-
7 mm range the overall precision could decrease.
2WIN, moreover, is able to detect the refraction only of
patients which eyes permit good Purkinje images.
Anomalies in such images, due for example to eye-surgery
interventions or intraocular lenses (IOL), do not allow an
accurate measurement.
2WIN incorporates sight and sound stimuli for the use with children and uncooperative patients (note that
sound is preferable to the sight stimulus).
2WIN is portable, battery powered, equipped with a computing integrated unit, with a display for verification
of the conditions of measurement and for displaying the results. This is controlled via push buttons.
2WIN data can be saved inside the device (inside a MicroSD Flash memory card) and downloaded outside the
instrument through USB connection or Wi-Fi. Moreover, data can be sent through email service to the
operator’s email address once it is saved in the 2WIN, or finally it can be sent to an email-printing-enabled
Wi-Fi printer.
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).

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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 –only for backwards compatibility
Model: WiFiHU-a
FCC ID
IC
Identifies the Wi-Fi transmitter
module
Model: LM820
FCC ID
Identifies the Wi-Fi transmitter
module
Model: LM817
FCC ID
Identifies the Wi-Fi/Bluetooth
transmitter module

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7.3 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 and maximum
temperature
Lithium ion batteries contained or packed with device
Call [phone] for more information
[phone]

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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.
MAIN FUNCTIONS
Short press
Long press
Patient side
BUTTON S1 & S2
Start focusing phase;
releasing, start a
measurement
Operator side
BUTTON A
Switch-on;
open Applications
Menu
Switch-off
BUTTON B
Zoom after exam
Print and Save
JOYSTICK
Navigate in the Menu
CENTER: contextual
help
BUTTON C
Toggle eye
Notification center
BUTTON D
Enable interactivity
features
Quick Menu
The buttons have different behaviors within the different submenus: these will be described in the
manual in the corresponding paragraphs.

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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.
The JOYSTICK features contextual functions:
•Push CENTER to enter Menu or to say OK.
•Short RIGHT push: activates auxiliary window. This window displays the results of main Application
(screening) and of additional Applications.
•Long RIGHT push: selection of age interval for standard screening. Push RIGHT to switch between 'Ok'
button, 'Cancel' button and the list of age intervals.
•Long UP push: changes positive and negative cylinder representation for the running measurement.
During the examination some keys change their function:
•Push LEFT to toggle ON/OFF the sound.
•Push RIGHT to toggle ON/OFF the light.
After the measurement:
•Push CENTER to enter Menu.
•Push RIGHT to display the auxiliary window.
Active keyboard mode buttons:
•JOYSTICK’s CENTER button: select the field (or letter) highlighted.
•JOYSTICK’s UP/DOWN/RIGHT/LEFT buttons: move between characters.
•BUTTON A: exit.
•BUTTON B: moves the cursor in different fields.
•BUTTON C: backspace.
•BUTTON D: resume.

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

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8Operative information
8.1 Operating conditions
The device needs to be operated under the following environmental conditions:
•Temperature: 10 to 40 °C (50 to 104 °F)
•Humidity (max): 90% not condensing
8.2 Unpacking
The box contains (default configuration):
•the 2WIN device
•two rechargeable batteries
•a MicroSD memory card (containing the electronic version of the Operator Manual)
•a USB cable (Micro-USB to USB-A)
•an external battery charger
•an occluder (infrared patient’s eye occlusion system)
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.
8.3 Insert battery
To insert the battery, slide the battery lock, hold it and gently open the battery door located in the lower side
of the device. Pay attention in inserting the battery with its connector facing down towards the instrument's
inside so that the connector of the battery matches the connector inside the device.
Close the battery door and lock it.

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8.4 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.
8.5 Battery-charging
Charge the batteries with the external battery charger provided.
On first usage, batteries need to be charged for at least 4 hours.
Batteries must be charged at least once every 30 days.
If used properly, 2WIN batteries have a lifecycle of 400 cycles of complete charge/discharge.
To correctly use the external battery charger, align the
battery’s contacts with the ones on the charger. When the
battery is fully charged, the light of the charger turns from
red to green.
To guarantee the correct battery charging, keep the battery charger horizontal with respect to the ground
during the entire charging process.
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

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8.6 Before operation
After charging the battery, be sure to set up the date and time. Current date and time will be also used into
the measurement results’ report. As soon as the battery is assembled and charged, and date/time have been
set, the device is ready for operation.
The device has an automatic hardware self-test procedure that can be activated as an option from Menu >
Functions > Aux > Auto test. This procedure may be executed any time to verify hardware integrity.
8.7 Data management disclaimer
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.
8.8 Software language
2WIN Software is available in English, French, German, Italian, Spanish, Turkish, Portuguese (BRA).
The default language is English.
Follow these instructions to load a different language pack in your 2WIN:
1. Download the translation file of interest on your PC from the following link:
https://www.adaptica.com/products/2win/ from the section Technical Information > SOFTWARE
TRANSLATIONS
2. Connect 2WIN to your PC through the Micro-USB cable, or read the 2WIN’s MicroSD card with the PC
3. Create a new folder named ‘TR’in the root directory of the MicroSD card
4. Copy the translation file in the ‘TR’directory
5. Safely remove the MicroSD device from your PC or disconnect your 2WIN from the PC
6. Reboot your 2WIN
7. At the next start 2WIN Software will be loaded with the selected language pack
Follow these instructions to return to the default English translation:
1. Connect 2WIN to your PC through the Micro-USB cable, or read the 2WIN’s MicroSD card with the PC
2. Create a new text file named “resetTranslation.xxx.txt”in the ‘TR’folder
3. Safely remove the MicroSD device from your PC or disconnect your 2WIN from the PC
4. Reboot your 2WIN
5. At the next start 2WIN Software will be loaded with the default English translation

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9Operative 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. After 600 seconds, the device’s screen turns on, emits a sound
alert, and shows a warning saying that after 30 seconds it will automatically shut down:
Default Auto shutdown Time is 10 min, and it’s changeable from a minimum of 10 to a maximum of 180
minutes, in steps of 5 min. It can be customized from Menu > Settings > Aux > Autoshutdown time.
To operate the instrument, it’s important to carry out the following four steps:
1. Environment setup
2. Device setup
3. Preparation of the patient
4. Measurement
9.1 Environment setup
The ambient light should be dim, there should be no direct light pointed towards the instrument or
reflected by the eyes of the patient. In case of bad light conditions during the measurement, a message may
appear indicating the specific condition.
The device can be used to evaluate the ambient light, from Menu > Functions > Light Meter.