DIVEL ITALIA S.p.a. in his capacity as manufacturer of ophthalmic lens Class I as provided in Art. III Part I of Annex IX to Directive 93/42/EEC and subsequent amendments, including Directive 2007/47/EEC, declares that products are conform to the applicable provisions for medical devices required by directives mentioned and introduced into italian law with D.Decree no. 37 of 25 January 2010 and in the harmonized standard EN ISO 14889 and EN ISO 8980

DIVEL ITALIA S.p.a.is registered on the list of the Italian Ministry of Health of manufacturers of medical devices with this code ITCA01030281

Register of Medical Devices of the Italian Ministry of health
Lens type Progressivo D.M.
CR 1.67 423634
PURO CONTATTO 424232
CR 1.61/42 423613
CR 1.74 423653
CR 1.560 423673
AZZURRA 424174
CR 1.490 HARMONY 423693
TRIVEX 423698
CR 1.499 423609
POLICARBONATO 1.58 423695
TITANIO 1.7 423697
LANTANIO 1.8 423694
CROWN 1.523 423699
SUNSENSOR 423696
Garanzia

Warranty Conditions

Divel Italy guarantees their lenses for a period of 24 months.
The validity of this warranty is subject to objective compliance with the recommendations of use set forth below.

Precautions for proper use

To keep the lenses longer, it is recommended:
  • To support the glasses being careful not to put the lenses in direct contact with hard surfaces;
  • Wash the lenses with just soap and water, or with specific products, never use chemicals and / or aggressive, use only microfiber cloths for drying;
  • Do not clean the lenses to dry, especially if there is the presence of dust particles;
  • Do not expose the lens to direct sources of heat for prolonged periods.
 

Defect s noticed on the lenses that are due to processing or material, Iike for example scratches, holes or smashes, can be accepted only if they do not exceed from “maximum acceptability” parameters. These parameters differ depending on the area of the lens on which the defect is noticed.

We can imagine Ienses like on image 1, divided in three areas with diameter:

AREA A: 30mm diameter, this must be a defect-free area

AREA B: area included between AREA A and AREA C (note number 1)

1 bright spot minor or equal to 0.08 mmq.
1 black spot minor or equal to 0.03 mmq.
1 threadlike inclusion minor or equal to 0.01 mmq.
2 threadlike inclusion minor or equal to 0.02 mmq if there is a distance of at least 2 cm between them.

AREA C: area included between the Iens‘ edge and a circle whose diameter is equal to the diameter of the lens minus 10 mm. In this area only one of the following defects is tolerated (note number 2):

5 bright spot s minor or equal to 0.08 mmq.
1 black spot minor or equal to 0.08 mmq.
1 threadlike inclusion minor or equal to 2.00 mmq.
1 scratch on the Iength minor or equal to 4.00 mmq.
1 threadlike inclusions minor or equal to 0.04 mmq.

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The esthetical control of the Iens surface must be carried out observing the oculars with the visor for an observation time ranging between:

8 seconds fur lenses
15 seconds for masks

Within this given time, defects indicated in areas A, B and C as above described. Visual controls must be made without optical means (naked eye) observing the lens as it goes from a light to a dark area of the visor.
Measurement s of the defect s will be made with a magnifier.

Mirroring control (note number 3):
Lenses and masks must fulfil the following requirements:

in area A no mirrorless points must be noticed;
in area B minor equal 0.04 mmq mirrorless points are admitted, only if at Ieast 2 cm from each other;
in area C minor or equal 0.08 mmq mirrorless points are admitted.

Color tone control:

This control must be carried out by placing the lens on the diffused light luminescent screen. The tone of the Iens color must be equal to that of the samples (see lens’s samples) (note number 4). No tone difference between the Ienses of the same pair of glasses (right & left lens) must be noticeable. No tinting differences Iike darker or Iighter stains are accepted.

Shade control:
Gradient lenses must be created in pair (right & left lens).
Gradient masks must have the injection point in the area where the mask will be cut (note number 5).

Furthermore symmetry between right & left Iens must be respected.
See image number 2:

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Pairing me two lenses on the visor the operator must verify that the maximum shading difference between the right & left lens must be 2 mm.
See image number 3:

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Height is calculated measusiring the space between the projection of the shading axe on the shelf, and me lover edge of the lens, space A2.

Both for masks and rough lenses, each sample of reference for the tint will have a line corresponding to the beginning or the shading.
Tolerance between +/- 3mm is accepted (note number 6).
See image number 4:

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Shading image control:

Shading inclinations from the horizontal axe are accepted only if the difference between the two edges of the shading axe is maximum 3 mm.
See Image number 5:

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How to carry out the control:

With a pencil you draw the extremities of the line of the shading axe.
You have to lie the lens on the millimiter paper on which you previously traced or the sample of reference (place the notch on the correct position) and next you have to mark the shading axe.

Mark the position of the two extemities on the rnillimiter paper.
Unite the two extremes obtaining the trace of the shading axe of the ocular that must be controlled and on the paper measure:

a) the height difference between the central point of the axe of the sample of reference and the central point of the shading axe of the ocular under control (shading +/- 3 mm.)

b) the height difference between the two extremes of the shading axe (shading height +/- 3 mm.).

c) for p airs of lenses, the height difference of the central point of the shading axe between the right & left lens is 3 mm.

In the accept ance area certain test’s on sample lenses can be carried out upon request of customers, or of the Technical Office.
These test’s are listed below:

—Adhesion (except from CR39):
draw squares on the surface of the lens with a cutter, obtaining 100 squares of 1 mm each. Stick on some tape 610 of 3M and energetically tear off the tape, than verify the percentage of squares on which the treatment did not come off.
ACCEPTABILITY 95%.

-Mirroring resistance test:

abrade the upper p art of the lens with a right rubber loaded with 1 kg of welght for 20 cycles.

—Thermal shock:

5 cycles test consisting in healing and cooling down the lens from 100C to 0C, time of each immersion: 50 seconds.

Note number one: only one of these defects.
Note number two: only one of these defects.
Note number three: white spot.
Note number four:

kindly note we will give our customers the wens <> and the lens <> in order to inform them about color variations.

Note number five: see image number six (below)

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Note number six; we’ll send you two pieces with the hilighted shading line for lenses B6, B8 diameter 78. B8 90×60, M6, M7