Frame, trial, universal, adult

GENERAL DESCRIPTION
Universal trial frame for adult patients, 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 an adult patient’s eyes.
Pupillary distance adjustable from 45 to 82mm.
Adjustable temple angle and length for adult head sizes, with self-lock
Adjustable bridge height with self-lock and smooth axis adjustment
Holds up to 10 trial lenses.

SUPPLIED WITH
1 x Storage/transport case

ITEMS REQUIRED BUT NOT SUPPLIED
Trial lenses

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: 0.15 kg
Volume: 1.5 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 12867

NOMENCLATURE
GMDN©: 32791
EMDN: Y21030302