1. GENERAL DESCRIPTION OF PRODUCT
This product (AKR550) aims to objectively measure the refractive power of the eye by using the light that is
projected to and reflected from the eyeground. It also aims to measure the radius of corneal curvature by
using the light that is projected to and reflected from the cornea.
As the feature of this device, the LCD is tilted to the vertical direction and horizontal direction so that the
angle can be adjusted.
As for safety consideration, see “5. Instructions for use” of this manual.
2. INTENDED USE DEFINED
This product (AKR550) aims to objectively measure the refractive power of the eye by using the light that is
projected to and reflected from the eyeground. It also aims to measure the radius of corneal curvature by
using the light that is projected to and reflected from the cornea.
Moreover, it can measure the pupil diameter by taking the image of the anterior eye of the examinee.
3. CLASSIFICATION DEFINED, RULE GIVEN
This product is the active device which does not belong to the category of the invasive/ non-invasive device
and does not intend the performances below.
Supply of energy / observation of physiological process/ irradiation of ionization radiation/ medication of
medicines etc.
Therefore, this is a class I medical device with a measuring function based on the rule 12 of MDD Annex IX.
4. CLASSIFICATION OF DEVICE
According to European directive on medical device, the AKR550 is a class I medical device.
It is marked 0459. Date of first marking is February 2016. The expected lifetime is 7 years.
Type of protection against electrical shock: Class I Equipment
Class 1 equipment is equipment in which protection against electric shock does not rely on basic insulation
only, but which includes an additional safety precaution in that means are provided for the connection of the
equipment to a protective earth conductor in the fixed wiring of the installation in which a way which
accessible metal parts cannot become live in the event of a failure of the basic insulation.
Degree of protection against electrical shock: Type B Equipment
Type B equipment provides an adequate degree of protection against electrical shock, particularly
regarding allowable leakage currents and reliability of the protective earth connection.
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