Adaptica 2WIN Manuale utente

2WIN

OPERATOR MANUAL

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

3 
 
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 


 
12 PRINT TO PORTABLE PRINTER...................................................................................................................................... 34 
13 MAIL PRINTING.......................................................................................................................................................36 
14 GAZE.....................................................................................................................................................................36 
15 CUSTOMIZATION .....................................................................................................................................................37 
16 NOTIFICATION CENTER..............................................................................................................................................38 
17 AGE SELECTION .......................................................................................................................................................38 
18 SCREENING TABLE....................................................................................................................................................39 
WIRELESS CONNECTIONS.................................................................................................................................................................................................... 40 
1 BLUETOOTH CONNECTIVITY........................................................................................................................................ 40 
2 WI-FI CONNECTIVITY ................................................................................................................................................40 
3 PAIRING AND TRANSFERRING A 2WIN EXAM TO VISIONFIT SC ......................................................................................... 41 
REMOTE CONTROL: 2WIN APP-CONNECTION WI-FI ............................................................................................................................................................. 47 
APPLICATIONS ................................................................................................................................................................................................................... 47 
SOFTWARE UPDATE INSTRUCTIONS.................................................................................................................................................................................... 47 
1 MANUAL UPDATE PROCEDURE....................................................................................................................................47 
2 AUTOMATIC UPDATE PROCEDURE................................................................................................................................47 
MAINTENANCE AND CLEANING INSTRUCTIONS................................................................................................................................................................... 48 
1 HOW TO CLEAN THE SYSTEM ...................................................................................................................................... 49 
2 STORAGE INSTRUCTIONS............................................................................................................................................49 
3 INSTRUCTIONS FOR THE CORRECT DISPOSAL OF THE DEVICE...............................................................................................49 
4 INSTRUCTIONS FOR THE CORRECT DISPOSAL OF 2WIN’S PACKAGING ..................................................................................49 
5 SEPARATE COLLECTION FOR ELECTRICAL AND ELECTRONIC EQUIPMENT................................................................................49 
TROUBLESHOOTING ........................................................................................................................................................................................................... 50 
ADDITIONAL INFORMATION............................................................................................................................................................................................... 51 
1 TECHNICAL SPECIFICATIONS........................................................................................................................................51 
2 2WIN RECHARGEABLE BATTERY SPECIFICATIONS............................................................................................................51 
3 WI-FI MODULES /BLUETOOTH ADAPTERS ....................................................................................................................51 
4 OTHER SPECIFICATIONS .............................................................................................................................................52 
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 
 
 

1Manufacturer identification

Manufacturer

Adaptica S.r.l.

Address

Via San Marco, 9/H

35129 Padova (PD) Italy

Telephone

+39 049 773 968

Mail

contact@adaptica.com

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

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.

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.

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.

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).

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.

Altri manuali per 2WIN

Questo manuale è adatto per i seguenti modelli

Indice

Altri manuali Adaptica Strumento di misura

Adaptica

Adaptica 2WIN Manuale utente

Adaptica

Adaptica 2WIN-S Manuale utente

Adaptica

Adaptica 2WIN-S Manuale utente

Adaptica

Adaptica 2WIN Manuale utente

Manuali Strumento di misura popolari di altre marche

Suaoki

Suaoki D40 Manuale utente

Elster

Elster BK-G1.6 Manuale utente

Endress+Hauser

Endress+Hauser Deltabar FMD71 Manuale

Duratool

Duratool D03128 Manuale utente

Vega

Vega VEGAPULS 65 Manuale utente

Tonghui

Tonghui TH2618B Manuale utente

Tenmars

Tenmars TM-801 Manuale utente

MSR

MSR 145 Manuale utente

TPS

TPS WP-82 Manuale utente

ELMETRON

ELMETRON CP-511 Manuale utente

PCB Piezotronics

PCB Piezotronics 003C30 Manuale utente

Tenma

Tenma 72-10465 Manuale utente

Endress+Hauser

Endress+Hauser Proline Promag 50 Specifiche tecniche

Siemens

Siemens SITRANS F Coriolis FCT030 Manuale elenco delle parti

KLINGER

KLINGER CMF V Series Manuale utente

EXFO

EXFO FTB-2 Manuale operativo e di manutenzione

Keysight

Keysight M8290A Manuale utente

ADTEK

ADTEK MW-5 Manuale utente