Eye chart,tumbling E,near,nonillum

GENERAL DESCRIPTION
Non-illuminated near visual acuity chart using Tumbling E optotypes arranged in lines of progressively smaller sizes. Designed for visual acuity assessment in children and individuals with limited literacy or language barriers.

Minimum Order Quantity (MOQ): 25

INTENDED USE
Used to measure near visual acuity at a standard testing distance, especially in children and individuals who cannot identify letters. Suitable for community and primary healthcare vision screening as well as comprehensive eye examinations by eye care practitioners.

TECHNICAL SPECIFICATIONS
Near vision chart with Tumbling E optotypes arranged in standardized orientations (up, down, left, right) with minimum range of 0.1 to 1.0 decimal visual acuity.
Designed for testing at 40cm.
Non-illuminated.
Lightweight and portable.

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