Adaptica 2WIN Manual de usuario

2WIN

OPERATOR MANUAL

Revision notes

Revision number

2.9

Publication date

2014/12/12

Hardware configuration version

Version 11.0 and

earlier

Firmware configuration version

2.7

Software configuration version

3.3

Summary

Revision notes.....................................................................................................................2

Summary .............................................................................................................................3

1.Manufacturer identification...............................................................................................5

2.Legend of symbols...........................................................................................................5

3.Glossary...........................................................................................................................6

4.Intended use of the device ...............................................................................................8

5.Classification and Applied Standards...............................................................................8

Classification according MDD 93/42/EEC, Annex IX ...........................................................8

Classification and type of applied parts ...............................................................................8

IP classification....................................................................................................................8

Electromagnetic compatibility ..............................................................................................8

Applied standards................................................................................................................8

6.Quick user guide ..............................................................................................................9

Important..............................................................................................................................9

The 2WIN.............................................................................................................................9

Main applications...............................................................................................................10

Exam conditions ................................................................................................................10

Exam procedure (Quick mode –default) ...........................................................................10

Measurement tips..............................................................................................................12

7.Description of the device................................................................................................13

Labels................................................................................................................................14

Package labeling ...............................................................................................................15

Interfaces...........................................................................................................................16

Graphical user interface.....................................................................................................20

8.Precautions....................................................................................................................21

9.Operative information.....................................................................................................23

Register your 2WIN ...........................................................................................................23

Operating conditions..........................................................................................................23

Unpacking..........................................................................................................................23

Insert battery......................................................................................................................24

Extract battery....................................................................................................................24

Battery-charging ................................................................................................................25

Please load the batteries with the external battery charger provided.................................25

Operative instructions........................................................................................................26

aEnvironment setup .........................................................................................................28

bInstrument setup ............................................................................................................30

Eye selection .....................................................................................................................30

Interactivity.........................................................................................................................31

Patient data........................................................................................................................32

Browsing Mode..................................................................................................................32

cPreparation of the patient...............................................................................................34

dMeasurement.................................................................................................................35

Menu..................................................................................................................................39

Quick menu........................................................................................................................46

Print ...................................................................................................................................49

Save exam.........................................................................................................................50

Meters................................................................................................................................53

Gaze..................................................................................................................................55

Hirschberg Test .................................................................................................................55

Customization....................................................................................................................56

Custom RGB sequence.....................................................................................................56

Notification Center .............................................................................................................58

Screening Mode.................................................................................................................58

Screening Table.................................................................................................................59

Upload ...............................................................................................................................61

Wireless (optional).............................................................................................................63

Packages...........................................................................................................................68

Default Package ................................................................................................................71

10. Troubleshooting.......................................................................................................75

11. Additional information ..............................................................................................76

12. Analitic index............................................................................................................77

13. Information for assistance........................................................................................77

1. Manufacturer identification

Manufacturer

Adaptica S.r.l.

Address

Via San Marco, 9/H

35129 Padova (PD)

Italy

Telephone

+39 049 773 968

Mail:

[email protected]

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

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

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.

Packages

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.

4. Intended use of the device

Instrument for the measurement of binocular and monocular refraction, via 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

6. Quick user guide

It's highly recommended to register your 2WIN at:

http://www.2winforvision.com/register

or sending an e-mail to [email protected] containing your Name, Surname

(or the name of your Organization), your Nationality and 2WIN serial number.

Product Registration allows us to send:

software updates

additional software packages

service information

helpful hints related to your product.

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.

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 thatmeasures 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.

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.

Exam conditions

The patient shall sit comfortably in a suitable exam room; infants should sit in an

adult’s lap. A uniform dim light environment is necessary.

The 2WIN accuracy is affected by external sources of 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 (Quick mode –default)

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 (possibility to activate a small central LED in the

2WIN Menu). 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) - the message "FOCUSING" will appear.

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