S0004250
Lens, trial, set
Trial lens set for use with trial frames during refraction testing and visual assessment procedures.
Indicative Price 95.79 USD
GENERAL DESCRIPTION
Set of spherical, cylindrical, and accessory trial lenses used for determining refractive errors such as myopia, hyperopia, astigmatism, and presbyopia. Includes filters and auxiliary tools for additional visual assessments.
INTENDED USE
For use by trained eye care professionals to determine the optimal combination of lenses for refractive correction or to assess visual function.
TECHNICAL SPECIFICATIONS
The trial lens set comprising a selection of 226 lenses.
Spherical lenses (positive and negative) ranging from 0.25D to 20.00D in standard 0.25D, 0.50D, and 1.00D steps.
Cylindrical lenses (positive and negative): from 0.25D to 6.00D in standard 0.25D and 0.50D steps.
Prisms from 0.50DP to 12 DP in 1DP steps.
Accessory components include green and red filters, occluder, pinhole, Maddox rod.
ITEMS REQUIRED BUT NOT SUPPLIED
Trial frame
SUPPLIED WITH
Storage/transport case with organized compartments and handle.
ESTIMATED LIFE SPAN
5 years
WARRANTY
2 years
ENVIRONMENTAL CONDITIONS
Operating conditions: 0 to 40C/ 90% relative humidity.
Storage conditions: -10 to 55C/ 95% relative humidity.
WEIGHT AND VOLUME
Weight: 4.75 kg
Volume: 24 dm3
QUALITY MANAGEMENT SYSTEM
Manufacturer is certified to ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes.
REGULATION & CONFORMITY REQUIREMENTS
CE-marked Class I medical device, self-declared under EU MDR 2017/745.
SAFETY & PRODUCT STANDARDS
ISO 9801
NOMENCLATURE
GMDN©: 36068
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