Eye chart,LEA,near,nonillum

GENERAL DESCRIPTION
Non-illuminated near 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 near visual acuity at a standardized testing distance, 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 by eye care practitioners.

TECHNICAL SPECIFICATIONS
Near vision chart with LEA optotypes.
Designed for use at 40 cm testing distance.
Double sided design: One side with proportionally spaced LEA symbols and reverse side with LEA symbols with 50% and 25% spacing for crowding assessment.
Includes an attached measuring cord to maintain the 40 cm testing distance.
Displays visual acuity in metric, decimal, and Snellen (feet) notation.
Allows estimation of near addition (ADD) using the printed columns.
Non-illuminated.

SUPPLIED WITH
Instructions for use in English.

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