Magnifier, handheld, non-illuminated

GENERAL DESCRIPTION
Handheld optical magnifier designed to provide magnified viewing of close objects or printed text. The magnifier consists of a single positive-power aspheric lens mounted in a round frame with a handle. Magnification level varies with the distance between the lens and the object, allowing fine adjustment and partial compensation for uncorrected refractive errors.

Minimum Order Quantity (MOQ): 10

INTENDED USE
They are intended for use by children and adults with low vision that cannot be fully corrected with spectacles or other treatment such as surgery.

TECHNICAL SPECIFICATIONS
Supplied as a set of three handheld magnifiers with optical powers and lens sizes: 12D/ 4X/ 50mm; 24D/ 7X/ 50mm; 36D / 10X/ 35mm.
Aspheric optical design for reduced distortion.
Lens material: Plastic.
Lightweight, impact resistant, and scratch-protected lens surface.
Frame and handle: High grade plastic.

SUPPLIED WITH
Storage and transport pouch.
Instructions for use in English.

ESTIMATED LIFE SPAN
5 years

WARRANTY
2 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©: 30045
EMDN: Y210699