S0004244
Retinoscopy lens, rack
Two-paddle retinoscopy rack with positive and negative lenses from ±0.50 D to at least ±10.00 D in 0.50 D steps. It is used with a retinoscope for quick and objective refraction assessment.
Indicative Price 19.20 USD
GENERAL DESCRIPTION
Retinoscopy lens rack consisting of two paddles - one containing positive lenses and the other negative lenses. Positive lenses are marked in red and negative in black.
INTENDED USE
Used by optometrists and ophthalmologists during retinoscopy to determine the approximate refractive error of the eye. During the test, the examiner holds different lenses in front of the patient’s eye and observes the movement of light within the eye to estimate the correction required.
TECHNICAL SPECIFICATIONS
Two-paddle retinoscopy rack with positive and negative lenses in 0.50D increments from ±0.50 D up to at least ±10.00 D.
Positive lenses in red, negative lenses in black.
Lens diameter between 10mm and 25mm.
Lenses recessed to prevent scratching.
Handle for easy grip and stable positioning.
Material: Durable plastic frame with optical grade lenses.
SUPPLIED WITH
Storage and transport case.
Instructions for use in English.
SHELF LIFE
Not applicable.
ESTIMATED LIFE SPAN
5 years.
WARRANTY
2 years.
ENVIRONMENTAL CONDITIONS
Operating conditions: 10 to 40C/ 90% relative humidity
Storage conditions: 0 to 50C/ 90% relative humidity
QUALITY MANAGEMENT SYSTEM
Manufacturer is certified to ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes.
Supplier is certified to ISO 9001 Quality management systems – Requirements.
REGULATION & CONFORMITY REQUIREMENTS
CE-marked Class I medical device, self-declared under EU MDR 2017/745.
NOMENCLATURE
GMDN©: 67550
EMDN: Y210399
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