luxvision LRK-7000 - Introduction and Safety Information; Introduction

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1.Introduction
1.1.Intended Use
The Auto Ref/Keratometer LRK-7000 is intended to be used to measure the refractive power of the eye.
1.2.Equipment overview
Automatic eye examination refractive power measurement device, LRK-7000 is the equipment that
measures refractive power of patient’s eyeball to show Sphere (SPH), Cylinder (CYL) and Axis (AXS)
information. Moreover, it can measure test subject’s corneal curvature and PD (Pupillary Distance,
distance between pupils) and pupil’s size. In particular, it is possible to measure Peripheral Corneal
Curvature separately when measuring corneal curvature, and it enables accurate prescription since it is
possible to know the information of the cornea’s center and periphery curvature individually.
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 class against electric : Type B
4. Protection against harmful ingress of water : Ordinary, IPX0
5. Degree of safety in the presence of a flammable anesthetic’s mixture with air or with oxygen or with
nitrous oxide: Not suitable for use in the presence of a flammable anesthetic’s mixture with air or
with oxygen or with nitrous oxide
6. Mode of operation : Continuous