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Visionix VX90 - IX.2 - Conformity to Directives and Standards; A) Electromagnetic Emissions

Visionix VX90
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VX90 - User Manual
44
Measurement specifications
Power Range -20 D to +20 D (step 0.12D/0.25D)
Astigmatism range 0 to 10D (step 0.12D/0.25D)
Axis range 0° to 180°
Axis step
Pupil diameter measured 2 mm minimum (step 0.1 mm)
Retro illumination IR light
PD Measurement 85 mm measuring range max, 1 mm display
unit
Keratometry Specifications
Corneal radius range 5 mm to 10 mm step (0.01 mm)
Corneal refractory power 33D to 67D (n=1.3375) (step 0.12D/0.25D)
Corneal astigmatic power 0 to 12 D (step 0.12D)
Axis range 0° to 180°
Axis step
Measurement diameter 2 mm to 12 mm
Peripheral K 4 external fixation target
(nasal/temporal/superior/inferior)
IX.2 - Conformity to Directives and Standards
The VX90 complies with the Medical Device Directive 93/42/EC, as amended by Directive
2007/47/CE and is in Class Im (rationale: rule 12 active devices intended for diagnosis).
CE0051 and with the RED Directive 2014/53/EU.
Lifetime of the product: 7 years
1rst CE marking: 2019-06
2.a) Electromagnetic Emissions
The VX90 is intended for use in the electromagnetic environment specified below. The customer
or the user of the VX90 should assure that it is used in such an environment.

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