S0004249
Frame, trial, universal, paediatric
Trial frame for placing, holding, and exchanging trial lenses in front of paediatric eyes during sight-testing procedures.
Indicative Price 39.05 USD
GENERAL DESCRIPTION
Universal trial frame used to hold multiple trial lenses and filters during refraction testing. Lenses are inserted into slots that can be rotated or flipped to adjust their position.
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
Eye frame used to hold different trial lenses in front of a paediatric patient’s eyes.
Pupillary distance range with 48 – 80mm.
Adjustable temple angle and length to fit paediatric head sizes, with self-locking mechanism.
Adjustable bridge height with self-lock and smooth axis adjustment.
Holds 6 standard 38mm trial lenses, three on each side.
SUPPLIED WITH
Storage and transport case.
Instructions for use in English.
ESTIMATED LIFE SPAN
2 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©: 32791
EMDN: Y21030302
Related Products
