Projector, visual acuity

GENERAL DESCRIPTION
Digital chart projector with a selection of optotypes and test charts for measuring visual acuity, assessing refractive error (spherical and cylindrical power and axis), and evaluating binocular and bi-ocular vision.

INTENDED USE
Used by eye care professionals to assess visual acuity, refraction, binocular vision, and other visual functions as part of comprehensive eye examinations. May be used by trained ophthalmic staff under supervision.

TECHNICAL SPECIFICATIONS
Eye charts with a minimum range of 0.1 to 2.0 decimal visual acuity for all ages and literacy levels.
Supports decimal and Snellen chart formats, each type offering 50 charts with various masks.
Includes optotypes such as Landolt C, Snellen letters, children’s symbols, and charts for astigmatism, fixation and binocular balance.
Provides horizontal and vertical line masks and single optotype isolation.
Allows up to two programmable chart sequences, each storing up to 50 charts or masks.
Working distance: 2 m to 7 m.
Projection magnification: 30x at 5m.
Projection screen: 530 mm (W) x 340 mm (D).
White LED illumination.
Luminance adjustable from 80 to 320 Cd/m2.
Voltage: 100-240V AC.
Power consumption: 30VA.

SUPPLIED WITH
Instructions for use in English.
Projection screen
Remote controller
Support and fixation platform
Dust cover
Spare fuse

WARRANTY
2 years.

ENVIRONMENTAL CONDITIONS
Operating conditions: 0 to 40C/ up to 90% relative humidity.
Storage conditions: -10 to 55C/ 10 to 95% relative humidity.

WEIGHT AND VOLUME
Weight: 5 kg
Volume: 20.25 dm3

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©: 35922
EMDN: Z1212012080