Spectacles,pre-made,adult,PAC-90

GENERAL DESCRIPTION
Pre-made single-vision spectacles for adults, supplied as separate frames and pre-cut lenses for local assembly and dispensing. Lens powers range from ±1.00D to ±3.50D in 0.25D steps and left and right lenses may have different powers to allow on-site customisation before dispensing.

INTENDED USE
For correction of refractive errors in adults where spherical single vision lenses are appropriate.

TECHNICAL SPECIFICATIONS
Lens power range: ±1.00D to ±3.50D in 0.25D steps.
Lens style: Pre-edged, spherical, single-vision lenses.
Lens material: Polycarbonate with hard anti-scratch coating and UV protection (at least 95 % absorption up to 400 nm).
Unisex frames made of plastic.
Pupillary distance for adult male (> 18 years) is 63 mm.
Pupillary distance for adult female (> 18 years) is 61 mm.
Frame hinge: spring type.
Colour options: black, tortoise, wine, blue. Additional colours may be available upon request.
No specialised tools or equipment necessary for assembly or dispensing.

Pack Configuration:
Each bundle comprises 90 adult frames and 180 pre-cut lenses with the full spherical power range from ±1.00D to ±3.50D in 0.25D steps represented within each of the 61 mm and 63 mm pupillary distances. Frames are supplied in a mix of colours and frame styles.

SUPPLIED WITH
Instructions for fitting, in English.
Each frame 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.

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

WEIGHT AND VOLUME (packaged)
Weight: 6 kg
Volume: 33.74 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