Nidek Medical AR-600, Руководство оператора

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§1
INTRODUCTION
1.1 Outline of the Product
This instrument is an auto refractometer, which objectively measures the refractive power of
patient’s eyes with infrared rays to obtain spherical, cylindrical powers and cylinder axis of lens,
which may correct the patient’s vision into emmetropia.
This instrument has a main body and a measuring unit integrated on one base. On the base is a
chin rest on the patient’s side and a printer on the operator’s side, which makes an output of
measurement results. On the main body is a TV monitor, switches, and a joystick, which are
used to make alignment or manipulation. The measuring unit has a measuring window, which
the patient looks into and which the infrared rays radiate on the patient’s eye.
1.2 Indications for use
The Model AR-600 Auto Refractometer is a diagnostic instrument that is indicated for use in
the automated measurement of refractive errors of the eye.
1.3 Classification
[Classification under the provision of 93/42/EEC (MDD)] Class II a
The AR-600 is classified into Class IIa system.
[Form of protection against electrical shock] Class
The AR-600 is classified as a class I instrument.
The class I instrument is an instrument in which protection against electric shock does not
rely on basic insulation only, but which includes an additional safety precaution that provides
for connection of accessible conductive parts to a protective (earth) conductor in the fixed
wiring of the installation. Therefore; accessible conductive parts cannot become activated in
the event of failure in the basic insulation.
Use the power outlet which is equipped with a ground terminal.
[Degree of protection against electrical shock] Type B Applied Part
The AR-600 is provided with a Type B Applied Part.
The Type B Applied Part provides an adequate degree of protection against electrical shock,
particularly regarding the following:
- allowable leakage currents
- reliability of the protective earth ground connection (If applicable)