Bioptron Light Therapy FAQ by Zepter International

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BIOPTRON Light Therapy – Frequently Asked Questions

1. ARE THE BIOPTRON LIGHT THERAPY DEVICES MEDICALLY APPROVED AND CLINICALLY TESTED?

Yes. The unique BIOPTRON Light Therapy System is cerFfied/medically approved in the EU as medical device in accordance with 93/42/EEC. BIOPTRON AG is cerFfied (ISO 13485, ISO 9001) as manufacture of medical devices. BIOPTRON Medical IndicaFon porZolio is clinically proven for wound healing, pain relief in rheumatology, sports medicine & physiotherapy, skin diseases, cosmeFc medicine, depression-SAD for adults, children and newborns. The therapy form using light waves has gained worldwide much recogniFon by doctors, physiotherapists, other health pracFFoners and beauty specialists and numerous scienFfic publicaFons confirm the posiFve results and effecFveness of light therapy. It is also approved by Health Canada as a medical device, Class II, to effecFvely treat wound and pain condiFons and selecFve skin disorders (wound management).

2. WHAT IS THE GUARANTEE PERIOD FOR THE BIOPTRON DEVICES? The BIOPTRON MedAll, BIOPTRON Pro 1 and BIOPTRON 2 devices are guaranteed for 5 years by manufacturer (BIOPTRON AG). 3. WHAT IS THE LIFE EXPECTATION OF THE LIGHT SOURCE?

Approximately 2 000 hours. It may need replacing ader approximately 20000 x 6 minute treatments. The lamp has to be sent back to the oﬃcial BIOPTRON Service Centre for replacement. The warranty for the light source is 2 years.

year

4. WHAT IS BIOPTRON LIGHT? BIOPTRON Light is generated by BIOPTRON Devices through a physical process. BIOPTRON Light is obtained through a system of special mulFlayer mirrors known as a Brewster mirror. BIOPTRON Light is polychromaFc (polychromaFc=several diﬀerent wavelengths) the visible spectrum has a wavelength of 480–3400 nm and a narrow band of infrared rays of 780–3400 nm. The light is incoherent, of low energy, and up to 95% of the light is polarized. The BIOPTRON Light spectrum does not contain UV radiaFon.

5. WHAT ARE THE PHYSICAL CHARACTERISTICS OF BIOPTRON LIGHT? A key physical characterisFc is polarizaFon, however the unique combinaFon of BIOPTRON Light characterisFcs: polarizaFon, polychromacy, incoherency and low energy are responsible for the inducFon of biosFmulaFon.

polarization

polychromacy

incoherency

low energy

6. WHAT IS BIOSTIMULATION? BiosFmulaFon is a reacFvaFon of cell funcFons so that regeneraFve processes can occur again. Due to the penetraFon of light through skin and underlying Fssues a great number of biological funcFons are sFmulated and balanced. The visible light spectrum is able to influence skin, Fssue and blood cells posiFvely and therefore, is suitable for medical and cosmeFc applicaFon as well as home therapy. Light induced effects at first, reach the skin, ader which they are transported to the enFre body. Affected cells opFmize their funcFon and improve their cell communicaFon capability.

7. HOW DEEP CAN BIOPTRON LIGHT PENETRATE UNDER THE SKIN? Light waves of different wavelengths penetrate trough the skin at different depths. Light waves in the visible light spectrum penetrate less through the skin while red light penetrate deeper with no overheaFng of the skin or other underlying Fssues. The immune system is sFmulated since visible light reaches blood cells through fine capillaries close to the skin surface (= photo modulaFon of blood). That is how the bioposiFve effect of BIOPTRON Light Therapy is transported by our blood the enFre body. A four minutes treatment will let the light sFmulate cells approximately 2,5 cm under the surface of the skin.

8. WHAT LEVELS DOES BIOPTRON LIGHT WORK TO AND BY WHICH MEANS?

BIOPTRON Light works at a cellular level; on the cell membrane and on the intercellular structures. Studies have shown an increase in the negaFve electric potenFal of the cellular membrane, as well as a growth of the intracellular ATP on exposure to BIOPTRON Light. Once absorbed by the cellular components, BIOPTRON Light promotes metabolic acFvity energizing the structures in the cell. Simultaneously, the infrared component of the BIOPTRON Light spectrum produces a local dilataFon of the small vessels bringing about an increase of the sanguine pressure to allow transportaFon of more oxygen and nutriFve substances to the cells. Thus, through the sFmulaFon of the cellular structures and growth of ﬁbroblasts, BIOPTRON Light can be used to rebuild damaged Fssues. It also has the systemic eﬀect as per regulaFon of hormonal status.

Human cell

Cell membrane

Mitochondrion

9. WHAT IS HYPERPOLIRZED LIGHT AND THE NEW FULLERENE FILTER?

Hyperpolarized light is a quantum medicine for a quantum body. HP light in the shape of thoroid rotates at the speed of 18 billion Fmes per second. Thanks to that incredible speed, thoroid loses neither energy nor informaFon about the perfect structure of HP light. Such structured light travels through the whole body indeﬁnitely and unstoppably, and it can treat structured body maqer. 75% of biological structures, such as biomolecules, collagen and hydrogen bonds, have the same type of symmetry as HP light. It is well-known that nature loves symmetry. In nature, when two enFFes possess the same symmetry, a resonant interacFon occurs. Unique, harmonized HP light transfers the natural and healthy symmetry to biostructures, repairing their disturbed symmetry, inducing harmonizaFon and the healing process. HP light has deeper penetraFon and more balancing eﬀect.

10. WHAT IS THE CORRECT APPLICATION OF BIOPTRON LIGHT?

Ø The light beam must be set at a 90 degree angle to the surface that is being treated. Ø The length of exposure is dependent on the disease and disease area being treated and can vary from 4 to 10 minutes. Ø The device should be held on the app. distance of 10 cm. Ø The light beam should not be moved during the treatment. Ø During facial applicaFon, the light beam should not be aimed into the open eyes; those who wear spectacles and/or contact lenses should remove them. Ø Please take the relaxed/comfortable posiFon during the applicaFon. Ø Always apply BIOPTRON Light Therapy on clean treatment area. Ø Ader cleaning, you may apply a thin layer of Oxy Spray before starFng the therapy.

11. WHAT ARE THE EFFECTS OF CHANGING THE DISTANCE OF THE BIOPTRON DEVICE WITH RESPECT TO THE SURFACE BEING TREATED?

The correct distance that the BIOPTRON device must be held relaFve to the skin is 10 cm, regardless of which device is being used. At this distance, the energeFc density on the level of the skin is 40 mw/cm2 – with the light dose of av.2,4/cm2, energy which determines the best effects of biosFmulaFon. If the distance decreases, the energeFc power increases and the local temperature rises 1-2 degrees. When the distance increases, the energeFc power decreases. In pracFce, physicians reduce the distance between the device and the area of treatment for the treatment of chronic rheumaFc disorders, and observed that increasing the distance is more effecFve for treaFng local inflammatory disorders. For SAD the distance can be extended up to 20 cm. 12. HOW TO MAINTAIN MY BIOPTRON LENSES?

There are several ways, if we are just talking about dust, then a dry cloth, similar to what you use for glasses. If you need to clean it properly with a wet cloth, than a wet cleaning cloth or glasses, or a window cleaner or even 70% ethanol. We would not however recommend disinfectant soluFons, mainly because the composiFon could be different, and if it is not alcohol based it could create problems. However, for the new Hyperpolarized filters, we only recommend dry cloths and water, because they are not made of glass, it is a different material that helps to embed the C60 molecule, so these filters could interfere with non-water based cleaning products. Most of the Fme it doesn't need to be disinfected because there is no contact with the skin, so the wet cleaning we would only recommend to people who might really need it, like denFsts etc.

13. WHEN DO YOU SEE THE FIRST SIGNS OF THE IMPROVEMENT WITH BIOPTRON LIGHT THERAPY? The degree of improvement depends on the paFent, the type and severity of the illness, the age of the paFent, any associated disorders, the level of immunity etc. Generally, the ﬁrst signs of improvement are seen ader 3 to 4 sessions. For example, in the case of some condiFons such as herpes, improvement was seen ader the ﬁrst exposure to BIOPTRON Light. AS A GENERAL INDICATION: Wound Healing: 2 - 3 days Allergies: 2 - 3 days Pain: 2 minutes to 1 - 3 days Virus Therapy: 3 - 4 days Acne: 2 weeks - 1 month (varies) ArthriFs Pain: relief in days / Mobility: Within 1-3 weeks

14. DO I NEED TO PAUSE AFTER A WEEK OR MONTH OF BIOPTRON LIGHT THERAPY TREATMENT?

No. As BIOPTRON Light Therapy is sFmulaFng the own healing potenFal, acFng in natural way, the Fssues are not becoming resistant to the therapy. 15. IS THERE A RISK OF OVEREXPOSURE WITH BIOPTRON LIGHT THERAPY? No. BIOPTRON Light is absolutely safe. Exposure to BIOPTRON Light is either once or twice

daily. The total number of exposures is dependent on health status and improvement and/ or recovery. The total number of exposures taken is unlimited and overexposure does not occur.

16. CAN BIOPTRON BE USED ON THE EYES? The light is absorbed via the eyes or the skin. For comfort it is

recommended to keep the eyes closed during eye/face treatments. The Bioptron light will pass through the eyelid easily. Take into consideraFon that sensiFvity to light in general can vary from person to person as well the eye health condiFon. 17. CAN I OBTAIN THE BETTER RESULT IF I USE BIOPTRON TOO OFTEN? No. The therapeuFc effecFveness is not necessarily increased by too frequent or too long applicaFons. The specified therapy Fmes and therapy distances for the BIOPTRON Light Therapy obtained a specific dose (quanFty of light per session). Please always consult the BIOPTRON OperaFng InstrucFons. 18. IT IS KNOWN THAT VITAMIN D IS SYNTHESIZED IN OUR SKIN BY SUNLIGHT. DOES THE BIOPTRON LIGHT HAVE SIMILAR EFFECT ON OUR SKIN TO THAT OF VITAMIN D? No. BIOPTRON Light does not produce any vitamin D. Vitamin D is synthesized when the

skin surface is exposed to ultra-violet (UV) rays. The BIOPTRON Light spectrum does not contain UV radiaFon. Yet, according to some researches, wavelengths up to 530nm can be beneﬁcial regarding vitamin D.

19. WHAT ADVANTAGES ARE OFFERED BY BIOPTRON LIGHT? BIOPTRON Light Therapy is a natural therapy, non-invasive and asepFc. It has good penetraFon into the Fssues and a short applicaFon Fme. It has no negaFve side effects, is easy to apply and used across mulFple fields. The recovery Fme for disorders such as injuries, burns, scars etc. increases by up to 30-40%, reducing paFent suffering and costs. All BLT devices are very userfriendly, handy and easy to maintain. 20. IS BIOPTRON LIGHT PREFERABLE TO LASER LIGHT?

Special devices produce Laser Light using a more complex and expensive physical process. The light is monochromaFc – has only one wavelength, polarized and has a variable energeFc density on the point on which it acts. Due to the risks involved, using Laser Light as a therapy requires specialized medical staff and equipment. The Laser Light could damage the skin and underling Fssues and in contrast, BIOPTRON Devices can be used safely with no risks by medical staff and by clients or paFents at home. The choice to use a treatment either with BIOPTRON Light or Laser Light is dependent on the physician and the disease; the type of the illness; the affected surface etc.

21. WHAT IS THE DIFFERENCE BETWEEN SUNLIGHT AND BIOPTRON LIGHT? In contrast to natural sunlight the technically synthesized Bioptron Light provides light therapy with controllable and therefore reproducible. Bioptron Light is always available when we need it.

22. CAN BABIES BE TREATED WITH BIOPTRON LIGHT THERAPY AND IF SO, FOR HOW LONG? Yes. Babies can be treated with BIOPTRON Light Therapy. Although the BIOPTRON

treatment of 4-10 min is safe, the length of the treatment Fme for babies could be decreased with the same eﬀecFveness in comparison with the length of Fme for adults. You may also use the blindfold because of their eyes sensiFvity.

23. ARE PREGNANT WOMEN ALLOWED TO UNDERGO BIOPTRON LIGHT THERAPY TREATMENT? Yes. BIOPTRON Light Therapy does not jeopardize the health of the mother or the infant. However, we recommend avoiding the exposure in ﬁrst 3-4 months of the pregnancy.

24. WHAT ARE THE NEGATIVE SIDE EFFECTS OF BIOPTRON LIGHT THERAPY? BIOPTRON Light Therapy has been used for treaFng various disorders for more than 20 years. No negaFve side eﬀects are known. The BIOPTRON Light spectrum does not contain any UV rays and is safe therapy. Please refer to the InstrucFons for Use – Safety chapter. In accordance with current regulaFons, appendices with updates to IFUs of BPro1 and B2, necessary warnings, contraindicaFons and treatment recommendaFons have been added.

25. WHAT ARE THE MAJOR BIOLOGICAL EFFECTS OF BIOPTRON LIGHT? The major biological eﬀects are: » acFvaFon and improvement of local and systemic microcirculaFon » improvement of cell metabolism » reinforcement of human defense system » enhancement of oxygen transport into skin and Fssues » sFmulaFon of lymphaFc acFvity » regulaFon of hormonal system » harmonizaFon of metabolic processes

26. WHAT ARE THE INDICATIONS FOR BIOPTRON LIGHT THERAPY TREATMENT? Clinical studies and medical pracFce have highlighted the beneficial effects of BIOPTRON Light Therapy treatment in the following clinically tested indicaFons: Wound Healing: » Leg Ulcers (ulcus cruris) » Decubitus (pressure sores) » Burns » Post-surgical wounds » Post-traumaFc wounds Pain Treatment: » RheumaFc Disease » Physiotherapy » Sports medicine Dermatological Disorders and Skin Problems: » Acne » Psoriasis » Herpes simplex and zoster » Superficial bacterial infecFons » Mucosal lesions

Depression SAD » Chronic faFgue syndrome » Lowered moFvaFon » Increased need for sleep » Increased appeFte and weight gain » The inability to feel happy » Jet-lag CosmeFcs for: » Improving the skin’s texture and elasFcity » Reducing the signs of aging

FOR HEALTHY AND SICK PEOPLE

27. HOW OFTEN SHOULD BIOPTRON LIGHT THERAPY BE APPLIED? BIOPTRON Light Therapy can be used as a prevenFve method – to reinforce the human defense system, once a day. BIOPTRON Light Therapy can also be used as a medical treatment twice daily- in the morning and in the evening. In some cases – cold/ﬂu, it may be used more frequently. For cases of chronic illnesses it is advisory to conFnue the treatment ader the end of the illness 2– 3 Fmes daily for maintenance and prevenFon.

28. WHAT ASSOCIATIONS CAN BE MADE BETWEEN BIOPTRON LIGHT, DRUG BASED MEDICATION AND PHYSICAL MEDICINE? During the prescribed treatment of various illnesses, BIOPTRON Light can be associated with drug based medicine, surgical treatments and other procedures of recovery (massage, medical gymnasFcs, acupuncture and electro-sFmulaFon). The physician will prescribe the best suited therapy and suggest whether BIOPTRON Light can be applied in combinaFon or as monotherapy.

29. DOES BIOPTRON LIGHT THERAPY INTERFERE WITH ANY OTHER METHODS OF TREATMENT E.G. WITH PHARMACOTHERAPY (DOSING PHOTO ALEGENTS)? No.

30. CAN BIOPTRON LIGHT THERAPY BE USED IF THE PATIENT HAS A BUILT-IN PACE-MAKER? Yes. BIOPTRON Light Therapy does not interfere with the operaFon of the

pacemaker. It is recommended that device be used with the stand, without touching the actual device whilst undergoing treatment. 31. WILL I GET A TAN FROM EXPOSURE TO THE LIGHT AND COLOUR THERAPY? No. You cannot get sunburn or a skin tan from the exposure to BIOPTRON Light Therapy as there are no UV rays present which are the rays responsible for tanning.

32. CAN BIOPTRON LIGHT THERAPY BE USED POST-OPERATIVE IF FOREIGN BODIES SUCH AS PROSTHESES, METAL PLATES OR SCREWS, SILICONE PROSTHESES HAVE BEEN BUILT IN? Yes. BIOPTRON Light Therapy does not aﬀect any built-in materials. 33. CAN BIOPTRON LIGHT BE APPLIED ON A BANDAGE COVERING A WOUND OR MEDICINAL LINIMENT?

No. For eﬀecFve treatment results, the bandage should be removed and skin should be clean from medicinal liniments.

34. HOW SHOULD THE TREATMENT ARE BE PREPARED BEFORE A THERAPY SESSION?

The treatment area should be perfectly clean. When treaFng open wounds any clothing or topical medicaFons should be removed. Regular cleaning of the wound should be done before using Bioptron (under doctor's supervision).or eﬀecFve treatment results, the bandage should be removed and skin should be clean from medicinal liniments.

35. CAN BIOPTRON LIGHT THERAPY BE USED TO TREAT VARICOSE VEINS? Yes. Although, it is not cerFﬁed medical indicaFon for use, the BIOPTRON Light Therapy enhances microcirculaFon and the quality of the skin. Due to the slight warming eﬀect of the light, the device should be held further away from the treatment area, and can be combined with the blue light as it is calming color.

36. CAN BIOPTRON LIGHT THERAPY BE USED TO CURE CANCER OR MALIGN DISEASE? BIOPTRON Light Therapy does not cure cancer or any other incurable disease. BIOPTRON Light Therapy could be used as an addiFonal therapy to heal postoperaFve wounds or to improve immunity. 37. CAN BIOPTRON LIGHT THERAPY BE USED TO TREAT RHEUMATOID ARTHRITIS? Yes. BIOPTRON Light Therapy has shown a posiFve eﬀect over a longer treatment period. It should not be used for acute periods of inﬂammaFon.

38. HOW DOES BIOPTRON LIGHT THERAPY FIGHT THE AGING PROCESS? BIOPTRON Light Therapy sFmulates: • cell renewal • ﬂow of nutrients • synthesis of collagen • promoFon of skin healing • skin's regeneraFve processes • skin's defense system

39. CAN BIOPTRON BE BENEFITIAL IN VETERINARY MEDICINE? Similar as in human medicine, Bioptron hyperpolarize light is also recommended and successfully used in veterinary medicine, in professional and home care of animals. Bioptron HP light is easy, effecFve, non-invasive method of treatment of wounds of different origin, skin problems, such as trichophyFa, alopecia, bacterial and allergic dermaFFs, demodicosis, as well as arthriFs pain, problems with cramping syndrome and inflammatory disorders, such as external ear canal inflammaFon, masFFs, etc.

40. CAN BIOPTRON BE BENEFITIAL FOR DEANTAL CARE? BIOPTRON Light Therapy in paFents with proven periodonFFs have shown very good results to decrease the producFon of MMP-8, which is a collagen cleaving enzyme and an inflammaFon marker found in oral fluids. BIOPTRON LIGHT THERAPY is clinically proven to: ² Reduce inflammaFon ² Eliminate unwanted pathogenic bacteria in wounds (blue light) ² Enhance the body’s immune response ² SFmulate the producFon of collagen by sFmulaFng fibroblasts (red and infrared wavelengths) Ease of use and excellent safety profile make BIOPTRON the ideal device for tooth plaque treatment and prevenFon. It can improve gingival and tooth health, and prevent tooth loss!

41. CAN TREATMENT WITH BIOPTRON LIGHT BE APPLIED TO DISORDERS OTHER THAN THOSE RECOMMENDED BY THE MANUFACTURER (BIOPTRON AG)? A physician and highly trained medical product consultant who is aware of the disease characterisFcs, the means by which BIOPTRON Light works, the effects at cellular level and its clinical effects (relieving pain, anF-inflammatory properFes, the sFmulaFon of cellular recovery etc.) could recommend the treatment. However, we always recommend that the paFent/client consult the physician before using BIOPTRON Light Therapy.

42. WHAT HAS TO BE OBSERVED BEFORE AND WHILIST OPERATION THE BIOPTRON? • • • • • • •

Make sure, when the lamp is switched on, that the air venFlaFon grid is not covered in order to allow good venFlaFon. Don’t unplug it from electricity Fll fan is sFll working and cooling the device. When you wish to adjust the stand, unFed the screw, don’t use the force. While changing the color lenses be sure that they are pushed to the end to prevent falling and braking. The best way to adjust the Pro 1 device is by holding the neck of the device with one hand and puyng the pressure on metal part with another hand. Regarding MedAll, be gentle while puyng the device in the holder. If you ever have the ERROR message, just unplug the cable directly from the device, wait for 10 seconds and plug in again. The device will restart itself like any other electrical machine.

43. ARE THERE DIFFERENT BIOPTRON DEVICES AND DIFFERENT SIZES?

Yes. In order to assure the best-ﬁyng soluFon for every need, the range of

BIOPTRON devices includes three different types of devices. This enables opFmum effecFve handling and use by both medical professionals and homeusers. They differ in size and design, but all three devices emit light with idenFcal physical and technical characterisFcs. Bioptron MedAll has a filter diameter of 5cm, Bioptron Pro 1 has a filter diameter of 11cm, Bioptron 2 has a filter diameter of 15cm so the difference is in the size of the treatment area. 44. DO THE DEVICES COME IN WITH FLOOR-STANDS?

Bioptron Pro1 is coming with a table stand and the floor stand is recommended but opFonal. We always recommend that Bioptron MedAll be purchased with the floor stand. For Bioptron 2 you may choose one of the available floor stands. The stand not only allows for a more comfortable treatment but it also allows you to treat areas of the body, which would be difficult to reach otherwise.

45. DO I NEED OXYGEN STERILE SPRAY?

With the purchase of device, you will receive complementary a boqle of Oxygen Sterile Spray, Swiss water enriched with a high concentraFon of pure oxygen. Use whenever you want to refresh and vitalize the skin. It can calm the skin ader-shaving or ader sun exposiFon. In regards of Bioptron treatment it is used to oxygate the Fssues and for cleaning as it is sterile, so the effect of light will be enhanced. 46. DO I NEED THE COLOUR THERAPY SET? The colours can enhance your treatment. You can use different colours : Ø To balance your energies in order to prevent possible health problems Ø To evoke chemical reacIons, which affect the funcIon of the different organs & systems. Ø To fill up the energy reserves of the Issues & organs, thus raising the body’s immune system. Colours can be used on pressure points, for chakra sImulaIon as well on different body’s areas according to the indicaIon.

47. WHAT ARE THE MOST RECOMMENDED TREATMENT AREAS FOR MAINTAINING A GOOD HEALTH? Face and eyes: to acFvate the pituitary gland Area of sternum (chest bone): to acFvate thymus gland important for immune system Roots of the foot: where all points connected to our organs are. Any area where we feel pain, inﬂammaFon, swelling, discomfort or spasm. Set your alarm 10-20 min. earlier and enjoy Bioptron light while you are sFll resFng in your bed. Take energizing boost during the day by 10 min. on your face. Give treat to the sole of your foot at the end of the day, while you are relaxing, watching TV or reading.