Adaptica 2WIN-S Manuale utente

2WIN-S

Plus

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 
SUMMARY ............................................................................................................................................................. 3 
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 
CLASSIFICATION AND TYPE OF APPLIED PARTS............................................................................................................................6 
IP CLASSIFICATION............................................................................................................................................................... 6 
ELECTROMAGNETIC COMPATIBILITY ........................................................................................................................................6 
APPLIED STANDARDS............................................................................................................................................................6 
5PRECAUTIONS ................................................................................................................................................... 7 
6QUICK USER GUIDE............................................................................................................................................ 9 
6.1 MAIN APPLICATIONS ....................................................................................................................................................9 
6.2 EXAM CONDITIONS.......................................................................................................................................................9 
6.3 MEASUREMENT TIPS...................................................................................................................................................10 
7DESCRIPTION OF THE DEVICE............................................................................................................................10 
7.1 2WIN AND 2WIN-S.................................................................................................................................................. 10 
7.2 2WIN-S.................................................................................................................................................................. 10 
7.3 PACKAGE LABELLING................................................................................................................................................... 12 
7.4 2WIN-S LABELING.....................................................................................................................................................13 
7.5 INTERFACES ..............................................................................................................................................................15 
8OPERATIVE INFORMATION...............................................................................................................................16 
8.1 OPERATING CONDITIONS .............................................................................................................................................16 
8.2 UNPACKING..............................................................................................................................................................17 
8.3 ACCESS TO 2WIN...................................................................................................................................................... 17 
8.4 BEFORE OPERATION ................................................................................................................................................... 18 
8.5 DATA MANAGEMENT DISCLAIMER .................................................................................................................................18 
8.6 IMPORTANT NOTES ON BATTERY ...................................................................................................................................18 
9OPERATIVE INSTRUCTIONS...............................................................................................................................18 
9.1 DEVICE SETUP ........................................................................................................................................................... 19 
9.2 PREPARATION OF THE PATIENT .....................................................................................................................................20 
9.3 MEASUREMENT......................................................................................................................................................... 21 
9.4 SAVE EXAM............................................................................................................................................................... 27 
9.5 GAZE.......................................................................................................................................................................28 
9.6 CUSTOMIZATION........................................................................................................................................................28 
10 WIRELESS CONNECTIONS..................................................................................................................................29 


 
1 BLUETOOTH CONNECTIVITY........................................................................................................................................ 29 
2 WI-FI CONNECTIVITY ................................................................................................................................................29 
3 PAIRING AND TRANSFERRING A 2WIN-S EXAM TO VISIONFIT SC ......................................................................................30 
REMOTE CONTROL: 2WIN APP-CONNECTION WI-FI..........................................................................................33 
REMOTE CONTROL: KALEIDOS APP...................................................................................................................33 
1 KALEIDOS APP:INSTALLATION AND CONFIGURATION.................................................................................................... 34 
2 REVIEW EXAMS USING KALEIDOS APP........................................................................................................................36 
3 KALEIDOS APP:SETTINGS........................................................................................................................................37 
2WIN-S PLUS (PACKAGE) ..................................................................................................................................39 
1 AI-APP:ANOMALIES DETECTION HINT OF ANTERIOR SEGMENT .........................................................................................39 
2 CR-APP:CORNEAL REFLEXES APPLICATION....................................................................................................................41 
3 EMR CONNECTION SET-UP ........................................................................................................................................47 
SOFTWARE UPDATE INSTRUCTIONS .................................................................................................................50 
1 MANUAL UPDATE PROCEDURE....................................................................................................................................50 
2 AUTOMATIC UPDATE PROCEDURE................................................................................................................................50 
DISINFECTION...................................................................................................................................................51 
MAINTENANCE AND CLEANING INSTRUCTIONS................................................................................................52 
1 HOW TO CLEAN THE SYSTEM ......................................................................................................................................52 
2 STORAGE INSTRUCTIONS............................................................................................................................................52 
3 INSTRUCTIONS FOR THE CORRECT DISPOSAL OF THE DEVICE...............................................................................................52 
4 INSTRUCTIONS FOR CORRECT DISPOSAL OF 2WIN-S PACKAGING ....................................................................................... 52 
5 SEPARATE COLLECTION FOR ELECTRICAL AND ELECTRONIC EQUIPMENT................................................................................52 
TROUBLESHOOTING .........................................................................................................................................54 
ADDITIONAL INFORMATION.............................................................................................................................55 
1 TECHNICAL SPECIFICATIONS........................................................................................................................................55 
2 RECHARGEABLE BATTERIES SPECIFICATIONS ...................................................................................................................55 
3 WI-FI MODULES /BLUETOOTH ADAPTERS .................................................................................................................... 56 
4 OTHER SPECIFICATIONS .............................................................................................................................................56 
5 DEVICE WARRANTY ..................................................................................................................................................56 
INFORMATION FOR ASSISTANCE ...............................................................................................................................57 
NOTE FOR SERVICE PERSONNEL ONLY ................................................................................................................ 57 
REMOTE CONTROL ...................................................................................................................................................57 
TELEMETRY ...............................................................................................................................................................57 
APPENDIX A –DATA MANAGEMENT DISCLAIMER .....................................................................................................58 
APPENDIX B –EMR INPUT AND OUTPUT FILES SPECIFICATIONS ................................................................................60 
 
 
 

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

Direct current (DC)

Warning: necessary information for safety

Important information

Read user manual before use

Indoor use only

Polarity of the power supply plug

Applied part –comes into contact with the patient

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.

Classification and type of applied parts

Class I, Type B.

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 FCCregulations, 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-S, including its cables.

The area where the device is to be installed has to comply to the IEC/ISO standards related to the

medical use of an area.

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.

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 0 - Operative

information.

The patient applied part, i.e., the face cushion, shall be disinfected before each patient change, to

avoid patient contamination by infectious agents. Please follow instructions provided on Chapter 4

–

Disinfection of present manual.

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.

Inside the 2WIN SD memory card is stored the patient data. This information can contain personal

information such as name/surname/age. This information management is responsibility of the operator.

Only the power adapter provided by Adaptica with the system can be used to charge the 2WIN-S’

battery pack, for safety reasons.

The battery cells of the 2WIN-S cannot be replaced with equivalent item not provided by Adaptica, for

safety reason (risk of explosion).

The battery cells of 2WIN-S cannot be replaced by the user, only by authorized service personnel.

Do not use different configurations of 2WIN and KALEIDOS to compose the 2WIN-S. The serial

numbers of 2WIN and KALEIDOS are matched to create the 2WIN-S, for manufacturing and warranty

reasons.

The operator is not allowed to perform a DOWNGRADE of the 2WIN-S software. Adaptica is not

responsible for the improper use of the device with a downgraded software version.

Do not place objects on top of the device and do not try to sit onto the device. Be sure that the device

is steady on the floor and not over other objects that can affect its stability.

6Quick user guide

Important

•Carefully read Chapter 5

–

Precautions of the present manual before operating the device.

•The 2WIN-S is a stand-alone binocular vision analyzer. It measures refraction of both eyes at the

same time.

•The 2WIN-S should not be confused with a table-top auto-refractometer (AR). ARs are designed to

measure refractive errors of one eye at time, in an artificial condition of far fixation.

•Please familiarize yourself with the measurement conditions and techniques of the 2WIN-S in order

to exploit its full potential.

6.1 Main Applications

•The 2WIN-S is a stand-alone 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 (IR) 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 children from 3 years of age to seniors.

•Early detection and documentation of multiple amblyogenic factors.

•Over-refraction of contact lenses.

•OPTIONAL (APP), CR-App: phoria/tropia measurements.

•PLUS package (2WIN-S Plus):

•CR-App: phoria/tropia measurements;

•AI-App: anterior segment screening warning customers of possible pathologies of the

anterior segment;

•Personalized tablet;

•EMR connection.

6.2 Exam conditions

The device should be paired with a tablet through Wi-Fi or Bluetooth connection, depending on the model.

6.3 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 18.1 for further information.

•Make sure the cylinder notation (minus or plus) is set to your preference.

•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.

•Remember that non-cycloplegic refraction can vary depending on several conditions pertaining to

the binocular visual function; in some specific patients, including accommodating children, the 2WIN-

S measurements may vary.

7Description of the device

7.1 2WIN and 2WIN-S

2WIN-S comprises the 2WIN and the accessory tube KALEIDOS.

A number of additional features of the 2WIN-S could be handled only approaching the 2WIN device.

Please, refer to the 2WIN Operator Manual for these options. This manual could be found in the

MicroSD inside 2WIN as well as downloaded at our website: adaptica.com > Products > 2WIN >

Manuals Download.

7.2 2WIN-S

The measuring principle of the 2WIN-S 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.

The 2WIN-S performs the measurement 1 meter (3 feet 3 inches) away from the patient’s eyes, with

continuous tracking of the corneal reflex, for the analysis of the binocular alignment. The device works as a

portable darkroom and allows a contact-less measurement between the patient and the operator.

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