Adaptica 2WIN User manual

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2WIN
OPERATOR MANUAL

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Revision notes
Software configuration version
4.2.170426
Publication date
2017/05/03
Hardware configuration version
Version 17.0 and earlier
Rev Num.
4.5

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1Summary
1SUMMARY......................................................................................................................................................... 3
1. MANUFACTURER IDENTIFICATION .................................................................................................................... 6
2. LEGEND OF SYMBOLS ........................................................................................................................................ 6
3. GLOSSARY ......................................................................................................................................................... 7
4. INTENDED USE OF THE DEVICE .......................................................................................................................... 9
5. CLASSIFICATION AND APPLIED STANDARDS ...................................................................................................... 9
CLASSIFICATION ACCORDING MDD 93/42/EEC, ANNEX IX........................................................................................................ 9
CLASSIFICATION AND TYPE OF APPLIED PARTS............................................................................................................................ 9
IP CLASSIFICATION............................................................................................................................................................... 9
ELECTROMAGNETIC COMPATIBILITY ........................................................................................................................................ 9
APPLIED STANDARDS............................................................................................................................................................ 9
6. QUICK USER GUIDE...........................................................................................................................................10
THE 2WIN ...................................................................................................................................................................... 10
MAIN APPLICATIONS.......................................................................................................................................................... 11
EXAM CONDITIONS............................................................................................................................................................ 11
EXAM PROCEDURE ............................................................................................................................................................ 11
MEASUREMENT TIPS.......................................................................................................................................................... 13
7. DESCRIPTION OF THE DEVICE............................................................................................................................14
LABELS............................................................................................................................................................................ 16
PACKAGE LABELING ........................................................................................................................................................... 18
INTERFACES ..................................................................................................................................................................... 19
GRAPHICAL USER INTERFACE................................................................................................................................................ 23
8. PRECAUTIONS ..................................................................................................................................................24
9. OPERATIVE INFORMATION...............................................................................................................................26
REGISTER YOUR 2WIN....................................................................................................................................................... 26
OPERATING CONDITIONS .................................................................................................................................................... 26
UNPACKING ..................................................................................................................................................................... 26
INSERT BATTERY................................................................................................................................................................ 27
EXTRACT BATTERY ............................................................................................................................................................. 27
BATTERY-CHARGING .......................................................................................................................................................... 28
DATA MANAGEMENT DISCLAIMER ........................................................................................................................................ 29
AENVIRONMENT SETUP .............................................................................................................................................. 31
BINSTRUMENT SETUP ................................................................................................................................................. 32
EYE SELECTION ................................................................................................................................................................. 32
INTERACTIVITY/ATTRACTION OF THE PATIENT.......................................................................................................................... 33
PATIENT DATA .................................................................................................................................................................. 34
BROWSING MODE ............................................................................................................................................................ 35
CPREPARATION OF THE PATIENT ................................................................................................................................... 36

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DMEASUREMENT ...................................................................................................................................................... 37
ZOOM FUNCTION .............................................................................................................................................................. 42
QUICK MENU ................................................................................................................................................................... 51
CONTEXTUAL HELP............................................................................................................................................................ 52
SUMMARY OF MENU ENTRIES .............................................................................................................................................. 53
PRINT TO PORTABLE INFRARED PRINTERS................................................................................................................................ 55
MAIL PRINTING ................................................................................................................................................................ 56
SAVE EXAM...................................................................................................................................................................... 57
HIRSCHBERG TEST ............................................................................................................................................................. 64
CUSTOMIZATION............................................................................................................................................................... 64
NOTIFICATION CENTER....................................................................................................................................................... 66
SCREENING MODE ............................................................................................................................................................ 66
SCREENING TABLE ............................................................................................................................................................. 67
UPLOAD.......................................................................................................................................................................... 69
PAIRING AND TRANSFERRING A 2WIN TEST TO VISIONFIT......................................................................................................... 69
11. WIRELESS CONNECTIONS..................................................................................................................................72
WIFI CONNECTIVITY .......................................................................................................................................................... 72
SFTP E VNC +SSH ACCESS CREDENTIALS ................................................................................................................................. 75
SFTP AND VNC+SSH SUGGESTED SOFTWARES ...................................................................................................................... 76
KEYBOARD COMMAND FOR THE USE OF VNC+SSH .................................................................................................................... 76
12. APPLICATIONS (PACKAGES) ..............................................................................................................................77
INSTALLATION .................................................................................................................................................................. 77
ACTIVATION..................................................................................................................................................................... 77
VISUALIZATION ................................................................................................................................................................. 78
AUXILIARY WINDOWS........................................................................................................................................................ 78
MODES (2WIN APPLICATIONS)................................................................................................................................... 78
13. SOFTWARE UPGRADE INSTRUCTIONS ..............................................................................................................79
14. MAINTENANCE AND CLEANING INSTRUCTIONS................................................................................................80
STORAGE INSTRUCTIONS..................................................................................................................................................... 80
INSTRUCTIONS FOR CORRECT DISPOSAL OF THE DEVICE.............................................................................................................. 80
SEPARATE COLLECTION FOR ELECTRICAL AND ELECTRONIC EQUIPMENT ......................................................................................... 80
15. 2WIN APPLICATIONS SPECIFIC MANUALS .........................................................................................................82
LEGENDS OF SYMBOL ......................................................................................................................................................... 82
2WIN APPLICATIONS INSTALLATION (THE SAME STEPS FOR EVERY APP) ....................................................................................... 82
ANALYSIS OF CORNEAL REFLEXES POSITION (CR-APP).............................................................................................................. 83
Corneal Reflexes exam ............................................................................................................................................ 85
Exam........................................................................................................................................................................ 85
Exam Results from ‘Corneal Reflexes’ App .............................................................................................................. 88
Print......................................................................................................................................................................... 91
Measurement reset ................................................................................................................................................. 93
DYNAMIC PUPILLOMETRY APPLICATION.................................................................................................................................. 94
Dynamic pupillometry application activation ......................................................................................................... 95
Dynamic Pupillometry exam and modes ................................................................................................................. 96
Exam........................................................................................................................................................................ 97

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Standard mode........................................................................................................................................................ 97
Manual mode .......................................................................................................................................................... 98
Calibration mode..................................................................................................................................................... 99
Exam display.......................................................................................................................................................... 101
Browsing mode...................................................................................................................................................... 102
Post exam measurements ..................................................................................................................................... 103
LENS CENTERING APPLICATION (LC-APP) ............................................................................................................................ 109
Lens Centering Application activating................................................................................................................... 109
Measurement with the App activated................................................................................................................... 110
Activation in Browsing mode................................................................................................................................. 111
Overview ............................................................................................................................................................... 111
Navigation............................................................................................................................................................. 113
How to position the horizontal axis....................................................................................................................... 113
How to position the vertical axes .......................................................................................................................... 114
Centering values.................................................................................................................................................... 114
Printing on SD and creating of the report ............................................................................................................. 115
INTERMEDIATE VISION TEST .............................................................................................................................................. 117
Components .......................................................................................................................................................... 117
Intermediate Vision application activation ........................................................................................................... 118
Intermediate Vision Exam ..................................................................................................................................... 119
Environment setup ................................................................................................................................................ 120
Exam...................................................................................................................................................................... 121
Output ................................................................................................................................................................... 123
16. TROUBLESHOOTING .......................................................................................................................................124
17. ADDITIONAL INFORMATION...........................................................................................................................125
TECHNICAL SPECIFICATION ................................................................................................................................................ 125
RECHARGEABLE BATTERY SPECIFICATIONS............................................................................................................................. 125
OTHER SPECIFICATIONS .................................................................................................................................................... 125
IN FLIGHT USE................................................................................................................................................................. 126
DEVICE WARRANTY.......................................................................................................................................................... 126
18. ANALITIC INDEX..............................................................................................................................................126
19. INFORMATION FOR ASSISTANCE ....................................................................................................................126
NOTE FOR SERVICE PERSONNEL ONLY .................................................................................................................................. 126
REMOTE CONTROL .......................................................................................................................................................... 127
TELEMETRY.................................................................................................................................................................... 127
20. APPENDIX A (DATA MANAGMENT DISCLAIMER) ............................................................................................128
21. APPENDIX B –HOW TO MANUALLY CONFIGURE SOME OF THE INFRARED PRINTERS.....................................131
PORTABLE PRINTER GEBE GPT-4378-FLASH-79-V.24-IRDA-SET ......................................................................................... 131
PORTABLE PRINTER SEIKO DPU-S_245 .............................................................................................................................. 133

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1. Manufacturer identification
Manufacturer
Adaptica S.r.l.
Address
Via San Marco, 9/H
35129 Padova (PD)
Italy
Telephone
[phone]
Mail:
[email protected]om
Web:
www.adaptica.com
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

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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.
Astigmatism
A condition in which the optical (or outer) surfaces of
the eye are distorted so that light rays are not sharply
focused on the retina for either near or distant vision.
Auto Shutdown
A procedure whereby 2WIN stops to work and switches
off automatically.
Auxiliary window
Graphical window that displays additional data.
Binocular vision
The use of both eyes simultaneously in such a manner
that each retinal image contributes to the final percept
of a single image.
Diopter
The refractive power of a lens. It is used as a unit of
measurement in refraction.
Esophoria
A tendency for the eyes to turn inward, when fusion is
suspended.
Esotropia
Marked turning inward of the eye; crossed eyes.
Exophoria
A tendency for the eyes to turn outward, when fusion is
suspended.
Exotropia
Divergent strabismus; abnormal turning outward of one
or both eyes.
Fixation
Movement of the eyes so that the visual axes meet and
the image of an object falls on the corresponding points
of each retina.
Focal point
The point to which rays are converged after passing
through a lens.
Heterophoria
A tendency for deviation of the eyes, when fusion is
suspended.
Heterotropia
A manifest deviation of the eyes resulting from the

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absence of binocular equilibrium.
Hypermetropia
Hyperopia.
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
blurred distant vision.
Occlusion
Obscuring the vision of one eye to test the vision or
force the use of the other eye.
Orthophoria
Parallelism of visual axes, the normal eye muscle
balance.
2WIN Applications
Additional software features that can be installed
directly on 2WIN.
Refraction
When referred to human eye, this term, or the term
Refractometry, are used to indicate the measurement
of the Refractive Error, that is the error in the focusing
of light by the eye.
Refractive Error
Equivalent to ametropia, it is usually decomposed into
a spherical error and a cylindrical error. Types of
ametropia include myopia, hyperopia and astigmatism.
Spherical error
Occurs when the optical power of the eye is either too
large or too small to focus light on the retina.
Strabismus
Failure of the two eyes to direct their gaze at the same
object because of inappropriate neuromuscular control
or because of fibrosis or paralysis of one or more
extraocular muscles, as in crossed eyes or walleyes.

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4. Intended use of the device
Instrument for the measurement of binocular and monocular refraction, dynamic
photoskiascopy.
5. Classification and Applied Standards
Classification according MDD 93/42/EEC, Annex IX
Class IIa
Classification and type of applied parts
There are no applied parts.
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 normative IEC60601-1-2.
Applied standards
EN 60601-1; EN 60601-1-2; EN ISO 15004

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6. 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
•The 2WIN is a binocular refractometer and vision analyzer. It measures refraction of
both eyes at the same time, at a distance of 1 meter.
•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. Please do not consider the 2WIN a small portable auto-
refractometer or two small ARs glued together!
•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.
Many other features can be measured by the 2WIN using optional applications
(2WIN APPs).
•Please familiarize yourself with the measurement conditions and techniques of the
2WIN in order to exploit its full potential.
The 2WIN
•The 2WIN detects a patient’s real-time refraction in the most natural environmental
conditions.
•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 in free space, while fixating at 1 meter.
•It must be operated in a dim light environment to ensure sufficient pupil size and
reduce accommodation.
•It is hand-held, battery operated, very light, non-invasive, fast and easy to use.
•It automatically measures binocular refraction, pupil distance, pupil size, direction of
gaze, and fixation abnormalities.

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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.
•Un-aided binocular refraction of all other patients
•Over-refraction of glasses or contact lenses.
•OPTIONAL (APPs)
•Phoria/tropia measurements
•Dynamic pupil response time and size caused by artificial light created by
2WIN
•Centering of the visual axis on the glasses frame
•Addition power measurement at the 66 cm distance from the patient
Exam conditions
•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; please make sure no direct light hits the patient’s face and ensure uniform
light on both eyes.
•A stable measurement distance of 1 meter is also important.
Exam procedure
•Turn the 2WIN ON by pressing the ON/OFF button for 1 sec. and wait until the
stand-by screen appears.
•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.
•Press and hold the START button to enter the focusing phase.
•Center the eye / eyes of the patient in the active display within the blue rectangle
(measurement area)

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Screen examination –blurred, not in focus. Adjust the distance from the patient
•Adjust the distance to focus the image until the top bar is green and the focusing
indicator based on corneal reflex shape appears in the centre of the screen.
•When the top bar is PERMANENTLY green and the focusing indicator (in the center
of the image) reaches the highest peak (as shown in the following photo) release
the BUTTON S1/S2.
Examination screen –focus OK
•Stay firmly in the condition in which the upper bar is green and the focusing
indicator is sharp until the message DATA PROCESSING appears on the display.

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Data Processing message
After Data Processing measurement results will be displayed.
Measurement screen
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” (myopia) or “high H”
(hyperopia). In the case the 2WIN displays “high M” or “high H” without displaying a
numerical result, 2WIN will write in the upper part of the display “n.a.” (not accessed
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 15D.
•Make sure the cylinder notation (minus or plus) is set to your preference.
•During the measurement mode, please make sure that both eyes appear within the
Graphical User Interface paragraph; if necessary, slightly tilt the 2WIN.
•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 5 (max.
is 9). In case of Reliability Index of 5 or less a message with a hint will be displayed.
Please repeat the measurement, if possible.
•Over-refraction with contact lenses is as easy and accurate as without correction.
•For accurate over-refraction with glasses, please make sure that no stray light
reflexes disturb the pupil detection; should such reflexes be present, please slightly
tilt the glasses down.
•Please remember that free space, non-cycloplegic refraction can vary depending on
several conditions and parameters pertaining to the binocular visual function; in

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some specific patients, including accommodating children, the 2WIN measurements
may vary.
7. Description of the device
The measuring principle of the device is based on eccentric photo-retinoscopy. 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.
This device 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 sensor for checking the measurement distance.
The device accepts a pupil diameter between 4 and 7 millimeters (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 range the overall precision could decrease) and is compatible with the measure in
mydriasis and in miosis.
It incorporates sight and sound stimula for the use with children and uncooperative
patients (sound are preferable to sight stimula). The device is portable, battery powered,
equipped with a computing integrated unit and with a display for verification of the
conditions of measurement and for displaying the results. This is controlled via push
buttons. It can be connected to a mini-printer, via IrDA (Infrared Data Association)
interface, to print the measurement results onto a strip of paper. 2WIN data can be saved
inside the 2WIN and downloaded outside the instrument through USB connection or WiFi

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LAN. Moreover data can be sent through email service to the operator email address once
it is saved in the 2WIN or finally can be sent to a email printing enabled WiFi printer.
ATTENTION: during any data access to the 2WIN data ad in particular when connecting
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).

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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
on waste disposal
Model
Fcc ID
IC
Identifies the Wifi transmitter
module

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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

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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
BUTTON D
IMPORTANT NOTE: the buttons have different behaviours within the different
submenus, these will be described in the manual in the corresponding paragraphs.
Long CENTRE push to display Contextual help that explain buttons functionality.
The CROSS BUTTON features contextual functions:
At starting the CROSS BUTTON is used to activate the menu and navigation: