Spectacles,ready-made,distance,PAC-140

GENERAL DESCRIPTION
Ready-made spectacles for distance vision, fully assembled with single-vision lenses in standard adult and children frame sizes. Lens powers range from ±1.00D to ±3.50D, in 0.25D steps with identical power in both eyes.

INTENDED USE
For correction of refractive errors (myopia or hyperopia) requiring distance vision correction.

TECHNICAL SPECIFICATIONS
Lens power range: ±1.00D to ±3.50D in 0.25D steps.
Lens type: Single vision.
Lens material: Polycarbonate with hard anti-scratch coating and UV protection (at least 95 % absorption up to 400 nm).
Unisex plastic frames, available in sizes suitable for adults and children aged 4 years and above.
Standard pupillary distance:
- Adult male (> 18y): 63 mm
- Adult female (> 18y): 61 mm
- Male 14-18y: 61 mm
- Female 14-18y: 59 mm
- Child 9-13y: 57 mm
- Child 4-8y: 52 mm
Frame hinge: hard screw.
Colour options: black, tortoise, wine, red.

Pack Configuration:
Each bundle comprises 140 assembled spectacles with the full spherical power range from ±1.00D to ±3.50D in 0.25D represented within each of the listed pupillary distances (63 mm, 61 mm, 59 mm, 57 mm, and 52 mm). Frames are supplied in a mix of colours and adult frame styles.

SUPPLIED WITH
Each pair of spectacles is supplied with:
1 x storage pouch
1 x cleaning cloth

OPTIONAL ACCESSORIES AVAILABLE BUT NOT INCLUDED
Spectacle straps.

SHELF LIFE
Not applicable.

ESTIMATED LIFE SPAN
3 years.

WARRANTY
1 year from date of shipment.

ENVIRONMENTAL CONDITIONS
Storage (0-50°C/90%).

WEIGHT AND VOLUME (packaged)
Weight: 5.2 kg
Volume: 28 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.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDR 2017/745 as Class I device.
US FDA device listing as a Class I medical device (510(k) exempt).

SAFETY AND PRODUCT STANDARDS
ISO 12870 at minimum.

NOMENCLATURE
GMDN© Code: 35065
EMDN Code: Y210303