User's Manual

Introduction

1.1. Intended Use

The CVS-1 Vision Screener is intended to be used to measure the refractive power of the

eye. It can measure refractive errors by detecting each eye from the eccentric lights. It is

possible to measure in either binocular or monocular. The values from the measurements are

compared with age based referral criteria. So, for some patient who need to visit a hospital,

recommend as screening result. It is intended for use on subjects from 6 months to adults.

1.2. Equipment overview

The Vision Screener, CVS-1 is the equipment that measures refractive power of patient’s eyeball

to show Sphere (SPH), Cylinder (CYL) and Axis (AXS) information. It can also measure test

subject’s PD(Pupillary Distance, distance between pupils) and pupil’s size. In particular, it is a

hand-held instrument and is easy to measure. It can visualize the patient’s eye image on the

LCD screen at the distance from the subject and align the measurement distance by ultrasonic.

It also provides visual and audible sound for the child to focus on the measurement. This

equipment provides a fast data for easy evaluation of the most pediatric subjects of limited

compliance. On the LCD display shows user interface functionality for data input and result.

Each result screening provides binocular or monocular assessment of the subject’s refraction

data, pupil information.

However, This equipment is not intended to replace a full eye care examination by an

ophthalmologist. The measured data is used for screening only, it must not be used directly to

prescribe.

1.3. Grade classification and mentioned items

1. Classification of product :

-. EU - Class I with a measuring function according to Annex IX (Rule 12) of the Medical Device

Directive 93/42/EEC

-. KFDA – Class II

2. Resistance against electric shock : Class I (earthed)

3. Protection against harmful ingress of water : Ordinary, IPX0

4. Degree of safety in the presence of a flammable anesthetics mixture with air or with oxygen or with

nitrous oxide: Not suitable for use in the presence of a flammable anesthetics mixture with air or

with oxygen or with nitrous oxide.

5. Mode of operation : Continuous