This document in the current version is part of the technical documentation of the company Walter Binde-GmbH & Ko KG and shows the intended purpose and the intended use of spectacle frames as a medical device. The intended purpose means the use with the corresponding information of the manufacturer on the label, in the instructions for use or in the advertising or sales material or the advertising or sales information and his information which is intended in the clinical evaluation" (Article 2 No. 12 MDR). This purpose statement is applied by the company Walter Binde GmbH & Co. KG to all spectacle frames and spare parts sold by us.
Purpose designation of spectacle frame:
Designation:
Prescription frame (in short, spectacle frame).
Product Description:
The term spectacle frames refers to a frame worn in front of the eyes with temples and two cut or colored lenses used as a visual aid or for eye protection. Spectacle frames are sometimes also referred to as ophthalmic lenses. The lenses used for visual aids are manufactured by the optical industry from mineral glass and plastic. They are edged by the optician and inserted into the spectacle frames, taking into account individual centering requirements.
Intended use:
The spectacle frame with optical lenses is intended to compensate for a visual impairment (low vision). The frame is mechanically fixed to the patient's head in front of the eyes by means of the temples.
Field of application: on the patient's head
Conditions of use: mechanical fixation
User: patient with visual impairment (low vision)
Duration: long-term use
Spectacle frames have been classified by Walter Binde GmbH & Co. KG in the sense of Regulation (EU) 2017/745 (MDR) and as previously in Directive 93/42/EEC (MDD) as non-invasive class 1 devices with long-term contact to the human body surface. Spectacle frames are non-active non-implantable ophthalmic devices intended to compensate for a visual impairment (visual defect).
MDR Code:
MDN 1206 non-active non-implantable ophthalmic products / MDT 2001 products manufactured using metal processing methods / MDT 2002 products manufactured using plastic processing methods
Ecri code/UMDNS 11-667 / GMDN code 32816
European Medical Device Nomenclature (EMDN) (europa.eu).
Q021002 - SPECTACLE FRAMES WITHOUT LENSES (general group)
Q02100203 - SPECTACLE METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES
BASIC UDI-DI
- 4066398F-MIX-FUL-ADL-9M (Metal & Plastic - Full rim spectacle frames - Adult)
- 4066398F-MIX-HAF-ADL-VN (Metal & plastic - Nylon spectacle frames - Adult)
- 4066398F-MIX-RL-ADL-A4 (Metal & plastic - Rimless spectacle frames - Adult)
- 4066398F-MIX-FUL-KID-BU (Metal & plastic - Full rim spectacle frames - Children)
- 4066398F-MIX-HAF-KID-XV (Metal & plastic - Nylon spectacle frames - Children)
Walter Binde GmbH & Co. KG has classified these medical devices as follows:
Classification according to Regulation (EU) 2017/754 : Class I Annex VIII (Classification rules: Chap1. Duration of use à1.3 / Chap4. non-invasive devices à 4.2) Conformity assessment procedures according to Annexes IX to XI.
Classification according to Medical Devices Directive 93/42/EEC: Class I, Annex IX (classification rule: III. 1.1), conformity assessment procedure according to Annex VI.
| 1. | Correct use of the spectacle frame | The spectacle frame (front) is placed on the nose and fixed to the ears with the temples. |
| 2. | Correct fit of the spectacle frame | The correct fit must be adjusted by the specialist personnel (optician) at the patient's so that the individually fitted lenses are at the correct distance from the eye. |
| 3. | Correct care of the spectacle frame | The spectacles may only be cleaned with skin-friendly cleaning agents and dried with a clean soft cloth. Alternatively, suitable spectacle frame cleaning agents or cloths may be used. |
| 4. | Correct storage of the spectacle frame | The spectacle frame should be stored in a case after use. Alternatively, it can be stored in a "safe" place, where the spectacle frame are protected from damage or extreme external influences, such as dirt, toxic or poisonous substances or thermal influences. |
| 1. | Incorrect fit of the spectacle frame | An incorrectly aligned spectacle frame can result in the prescription lens not being able to develop the correct visual acuity. The patient may experience visual disturbances and headaches as a result. Incorrect fit can occur due to improper fitting by the professional (optician), an accident situation where the spectacle frame was bent, or lack of maintenance of the spectacles. |
| 2. | Incorrect handling of the spectacle frame | Although the spectacle frame is "self-explanatory", it is possible to put the spectacles on the wrong way round. In this case, the patient's visual acuity is not corrected. Such situations are usually quickly recognized and corrected by the patient himself. |
| 3. | Incorrect care/cleaning of the spectacle frame | Cleaning agents with chemical additives such as ammonia or other aggressive agents can cause allergic and/or toxic reactions. Additives that are irritating to the skin can also cause damage to the skin. This also includes cleaning agents used in ultrasonic cleaning baths. Often, cleaning the spectacle frame is not enough to restore a "clean" surface. In this case, only an additional new allergy protection coating can be applied. As well as the replacement of the nose bridge and cell parts. A care note for the information of the seller / specialist staff (optician) is available. |
| 4. | Contact with allergic, toxic and/or skin-irritating substances. | Allergic, toxic and/or skin-irritating substances can cause damage to the skin and/or reactions when they come into contact with the spectacle frame. These contaminants on spectacle frame often cannot be remedied with "normal" cleaning. A replacement of the spectacle frame or an additional new allergy protection coating is then necessary. As well as the exchange of the nose bridge and cell parts. |
| 5. | Contact of the coating with solvents | Solvents can dissolve the surface of epoxy resin coatings. In the softened state of the coating, parts (substances) may detach from the coating. Patients who are prone to epoxy allergies may experience an allergic reaction. A "softened" coating can also leak and the base material could (stainless steel with 9% nickel) cause a reaction. A replacement of the spectacle frame or an additional new allergy protection coating is then necessary. |
| 6. | Thermal influences | Strong heat can deform the plastic parts of the spectacle frame. Deformation can cause the spectacle frame to fit incorrectly. If the jaws or temples are deformed, the spectacle frame may no longer be able to support the wearer and must be straightened by qualified personnel (opticians). Very strong cold, can cause plastic parts to break. This would make the spectacle frame unusable. Metal spectacle frames can become hot and cause burns. |
| 7. | Mechanical influences | If the spectacle frame is repeatedly removed from one side, there is a possibility that the spectacles will bend. For example, the jaw is bent outwards. As a rule, this is absorbed by spring hinges. Spectacle frame without spring hinges are more likely to be affected. If the jaws and/or temples are deformed, it can happen that the spectacle frame is no longer sustainable and must be straightened again by specialist personnel (optician). |
| 8. | Accident situations without personal injury | Due to different accident situations the spectacle frame can bend or even break. Possible accident situations are, for example, someone sits on the spectacle frame, the spectacle frame falls down or is mechanically destroyed. In this case, the frame is unusable or severely bent and must be examined by qualified personnel (optician). |
| 9. | Accident situations with personal injury | Personal injury accident situations (injuries) are possible in all situations. Examples include school sports, recreation, car accidents, personal or work accidents. Known are usually abrasions in face. Injuries to the eye (eyeball) have not yet occurred, but are quite possible. In this case, the frame is unusable or severely bent and must be examined by qualified personnel (optician). |
| 10. | Saltwater | Swimming in the sea or in a brine bath (salty swimming pool) is not suitable for spectacle frames. Salt water which settles in the hinges or in the upper rim (T-profile) of nylon thread spectacles, attacks the base material at these points. The base material is not coated at these points. When the water dries off, the salt begins to corrode and rust with the stainless steel. The spectacle frame are unusable and must be replaced. |
| 11. | Lack of care | Lack of care of the spectacle frame makes it unusable. Dried sweat or dirt will cause the mechanics of the hinges to suffer. Extreme sweat settles on the spectacle frame, and the epoxy coating can be damaged in the process. The nose bridges must also be changed regularly by qualified personnel (opticians), otherwise a "plug" of old sweat residue can settle behind the nose bridges. |
| 12. | Incorrect use of sunscreen Clip On's | Sunscreen Clip On's should not be used on the road at dusk, dark or in bad weather. This can lead to a car accident. Likewise, do not look directly into the sun with a sunscreen Clip On. This can cause glare to the eye. A warning notice is included with each sunscreen Clip On. |
| 1. | Abnormal use as safety spectacle frame | Prescription spectacle frames are not designed to be used as safety spectacle frame. Safety spectacle frame must be designed in such a way that splinters or splashes are prevented from reaching the eyes from the side as far as possible. A prescription frame (spectacle frame) is not designed for this purpose. |
| 2. | Abnormal use of sun clip on's as protective or welding protection | Prescription spectacle frames with sun clip on's are not designed to be used as protective eyewear or welding goggles. Safety spectacle frame must be designed to prevent splinters or spatter from entering the eyes from the side as much as possible. A prescription frame (eyeglass frame) is not designed for this purpose. Normal sun spectacle frame are completely inadequate as welding safety goggles; the eyes can be dazzled and damaged. |
| 3. | Abnormal use of spectacle frames as sports spectacle frame | The spectacle frames from Walter Binde GmbH & Co. KG, especially the children's spectacle frame, have not been designed and constructed as sports spectacle frame or school sports spectacle frame. These spectacle frames are only designed for "normal" wearing use. |
Care instructions for spectacle frames & patient information:
Please be careful not to expose spectacle frames to aggressive chemical cleaners or disinfectants. In particular, acetone, nitro thinner, turpentine substitute, petroleum ether, vinegar essence, ammonia solution and cleaning agents containing chlorine should be avoided. Such substances can attack the color design of the eyeglass frame, the biological properties of plastic spectacle frames and the anti-allergic protective coating of metal spectacle frames. Incorrect cleaning agents or chemical substances can trigger allergic and/or toxic reactions in the patient.
Warning/safety instructions and restrictions on use are implemented directly as a notice in the packaging of the spectacle frames (magnetic clip-on spectacles only)
MAGNET-SUN-CLIP-ON FOR GENERAL USE
Field of application: The magnetic sun clip-on from Walter Binde Optik GmbH & Co. KG protects the eyes from the harmful effects of solar radiation. The Magnet-Sun-Clip-On meets the basic safety requirement of the European Regulation EU 2016/425 and complies with the following standard regulations: EN ISO 12312-1. Application restrictions: Not suitable for driving in twilight, darkness and at night, as well as in poor visibility conditions. The Magnetic Sun Clip-On must not be used for direct sun observation or as protection from artificial light sources. Light and glare sensitivity, especially under conditions of increased brightness such as on snow, on the beach, or on the open ocean, vary from person to person, but it should be noted that the brighter Category 0 and 1 filters provide adequate protection in the UV range, but only slightly reduce solar radiation in the visible range. In normal use, the magnetic sun clip-on has sufficient mechanical strength. However, it cannot be used to protect against impact or shock, as the Magnetic Sun Clip-On may break and cause injury to the face and eyes. Pacemaker patients: The spectacle frame and clip-on contain magnets and should not be placed in close proximity to an implanted pacemaker. If you have any further questions, please contact your doctor! Storage: The Magnet-Sun-Clip-On should be stored in a case at a temperature between -10 °C and +35 °C. Do not leave the magnetic sun clip-on in closed or air-conditioned rooms (e.g. in the glove compartment in the car), because the functionality of the magnetic sun clip-on can be impaired by the temperatures reached under these conditions. In case of wear (e.g. scratches, dullness) of the Magnetic Sun Clip-On, it should be replaced with original parts. Cleaning: Clean the Magnetic Sun Clip-On under running water with a normal liquid neutral cleaner and dry it with a soft, clean cloth. Do not use solvents (e.g. alcohol and acetone) and aggressive chemical cleaners, which may impair the functionality of the Magnet-Sun-Clip-On. Marking: The model marking is located inside the frame. The magnetic sun clip-on with polarizing lenses corresponds to filter category 3 and is marked with a sticker on the support lens and on the inside of the bridge. This information brochure has been prepared in accordance with Annex II Sections 1 and 2.3 of the European Regulation EU 2016/425.
Delivery of the spectacle frame to the end user (EV)
The dealer (optician) instructs the end user in the intended use of the spectacle frame, including proper care and handling. The dealer informs the end user about any restrictions of use and risks. These are described in the instructions for use above.
Instructions for use are exceptionally dispensable for Class I medical devices if safe use of these devices is guaranteed without instructions for use.
Since the spectacle frame are supplied to the end user by professionals (opticians) and the end user is informed about the correct use, restrictions of use and risks, the safe use of the product is ensured even without instructions for use. Therefore, lenses and spectacle frames are supplied by the manufacturer without instructions for use. If necessary, these instructions for use should be applied.
Remark:
Any subsequent processing of the spectacle frame by the optician (repair such as soldering or cementing) which changes the structure of the originally supplied spectacle frame, as well as the replacement of parts (e.g. nose bridges, cell ends) or foreign coatings (allergy protection coating) which are not original from Walter Binde GmbH & Co. KG is carried out under its own responsibility and excludes any liability on the part of the manufacturer.