Eye chart,LEA,distance,nonillum

GENERAL DESCRIPTION
Non-illuminated distance visual acuity chart using LEA symbols arranged in a progressive reduction of size. Designed for visual acuity assessment in young children and individuals with limited literacy.

Minimum Order Quantity (MOQ): 25

INTENDED USE
Used to measure distance visual acuity, particularly in young children (typically from around 2.5 years) and individuals who cannot identify letters. Suitable for use in vision screening and in comprehensive eye examinations performed by eye care practitioners.

TECHNICAL SPECIFICATIONS
Distance visual acuity chart with LEA optotypes arranged in progressively smaller line sizes with a minimum range of 0.1 to 1.25 decimal visual acuity.
Double-sided design: One side with proportionally spaced lines (ETDRS format) and reverse side with Massachusetts Visual Acuity Test layout.
Includes hole for wall mounting.
Lightweight and portable.
Non-illuminated.

SUPPLIED WITH
Instructions for use and maintenance in English, French and Spanish.

ESTIMATED LIFE SPAN
3 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©: 16800
EMDN: Z1212012099