BIOPTRON Medical Product Consultant MPC

OBJECTIVES

• Introduction to BIOPTRON AG
• Guidelines and Medical Marketing
• Role and Responsibility of a BIOPTRON MPC
• Safety Aspects of Medical Products
• BIOPTRON Light Therapy - The Devices
• Light Therapy - ancient approach and modern achievements
• BIOPTRON Light Therapy - characteristics, indications, application and features

BIOPTRON AG is located at Wollerau close to Zurich in the economic center of Zwitzerland

• Founded in 1988
• Swiss Manufacturing Company
• Holder of the patents for the BIOPTRON Light Therapy devices
•   

• BIOPTRON was integrated into the international Zepter Group in 1996
• BIOPTRON AG distributes in more than 55 countries worldwide

Overview of Standards

1 - ISO 13485 is based on the ISO 9001 legislation which is the international foundation for quality management systems for manufactuers of medical prodcuts.

2 - Then there is the directive for medical devices issued and directed by the European Community which is 93/42/EEc (Amendement 2007/47/EEC)

For example the German act on medical devises for the implimntation of European devices in National law e.g. MPG (DE) and then there is the Quality system regulation Food and Drug Adminsitration (FDA) governing the United States of America which is termed 21 CFR 820

Finally, as an example, there is the Swiss federal law on therapuetic producs HMG (CH) with the Swiss Medical product orinance MepV (CH)

European Community Directive for Medical Products 93/42/EEC Amendment 2007/47/EEC

Medical Products Definition

Medical Products are: instruents, apparatuses, devices, sofware, substances and substance preparations, or other prodcuts used indepently or comined with others, which are to be used on human being including the methods of use for the prupose of diagnosis, prevention, monitoring, treatment or alleviation of disease or physicaldefects, examination of phyysiological processes, or for the purpose of birth control. . .

Some examples are NMR Tomograph - Inahler - X-Ray devices - Blood pressure meter - Medical softward and, ofcourse, BLT devices

Classification:

BIOPTRON Light Therapy devices are clasified as Class II1 devices. they are non-invasive, active medical devices

CE-Symbol for medical products

CE 0124 (with 0124 being the notified body)

CERTIFICATES

INSERT IMAGES QUALITY MANAGMENT QUALITY ASSURANCE

Certificate according to ISO 9001 by DEKRA ITS

Certificate accoding to EN ISO 13485:2003 + AC:2007 by DEKRA ITS Certificate according to 93/42/EEC with Annex DEKRA ITS Declaration of Conformity for BIOPTRON MedAll

Declartions of Conformity

The BIOPTRON Medical Product Consultant

RESPONSIBILITES

• Providing users with detailed information on the BIOPTRON Light Therapy System
• Instructing users in the proper handling of the devices
• Independent demand for information from the distributor or manufactuer at regular intervals

DUTIES

Duty to inform:

• Keeping written reports of statements on side effects, contraindications, falsification, etc., that occur in conneciton with the BIOPTRON Light Therapy and reporting of the same in writing to BIOPTRON AG(1)

1 BIOPTRON AG provides a special document ("Report on Hazards or Incidients") for this purpose

Report Document contains date of incdent, name and addreses of people involved, a description of the incident and in as much detail as possible. This document has to be returned to BIOPTRON within five days.

Safety

Responsiibility

BIOPTRON AG performs product observation

Purpose: End User and/or user safety

Main duties of the safety department:

• Collecting and evaluating all incoming reports on risks connected with the BIOPTRON Light Therapy systems
• Coordinating and monitorin g of all necessary measures
• If necessary informng the responsible authorities

MEDICAL PRODUCTS

Light Therapy Devices

BIOPTRON MedAll

BIOPTRON PRo 1

BIOPTRON 2

Pictures

Code numbers to insert

Medical Devices

Technical Parameters

Different are

Fileter diameter

MedAll approx filter diameter 5 cm

Bioptron Pro 1 approx filter diameter 11 cm

BIOPTRON 2 approx filter diameter 15 cm

Idential

The technical characteristics of BIOOPTRON Light

BIOPTRON MedAll

BIOPTRON Pro 1

360 degree rotation of the head Image

s to insert Free adujustable head inclination - Adjustable table stand height - Digital display - 10 cm distance rod

BIoptron Pro 1 with table stand PAG-990 BiOPTRON Pro 1 with floor stand PAG-991 Floor assembly instructions image

BIOPTRON 2 PAG-880

Y-stand (or domestic stand) PAG-883-Y and Professional stand PAG-881

Assembly instructions

Biopton Pro 1 Operating instructions

BIOPTRON MedAll operating insturctions

Repairs

Repairs to the BIOPTRON devices may only be acarried otu by an authorized BIOPTRON Service Centre

Details are availale on request to BIOPTRON AG
Guarantee Ceertificate Images

Thoroughly fill in the Guarantee Certificate

10 Model name and serial number, filled in from BIOPTRON AG

20 Dealer data and stamp

3) Purchase date

4) Name and address of the customer

5) Distribution/Produciton

History of Light Therapy and Development of the BIOPTRON Light Therapy System

Ancient Light Therapy

The use of sunlight in medicine has a long history. In ancient Egypt sunlight was used for various treatments

Later, Greek, Roman and Arabian physicians brought light therapy into general use.

Modern Light therapy

At the beginning of the 20th Century modern light therapy was founded by Neils Ryberg Finsen.

BIOPTRON Light Therapy

A Hungarian team of scientists investigated the effect of laser therapy.

Conintuned research led to the creation of a new light technology

Bsed on those findings the BIOPTRON Light Therapy system was created

The BIOPTRON Light TherapySystem has been developed in close cooperation with reserach department in unviserites and clinics such as those in St. Petersburg, Russia; Belgrade, Serbia and Montenegro as well as The University Hospial in Gent, Belgium

Unique Characterstics of BIOTRON Light

Electromagnetic Watve

There are four key components

Polarization

The lightwaves are moving on parallel planes.

Up to 95% of the emitted light is polarized.

This high degree of polarisation is reahed by reflection on a physical mirror system : The Brewster mirror

Polychromacy

Wide range of wavelengths including visible and part of the infrared range.

No UV radiation Wavelngth range 480 - 3400 nm

Inchoerency

The lightwaves are not synchronized, they are out of phase.

Low Energy

BiIOPTRON Light has a low energy density (fluence) of approximately 2.4 Joune/cm2 per minute

These four unqiue characterstics of BIOPTRON lead to BIOSTIMULATION

stimulation of biological processes in the body in a positive way

BIOPTRON Light Therapy acts in a natural way bu spporting the regenerative capacites of the body and therefore helps the body to release its own healing potential.

Light penetration into tissue IMAGE

Bioostimulation effects of BIOPTRON Light

• Improve microcirculation
• Reinforcment of the human denses system
• stimulation of the regenerative and reparative processes in the entire body
• Promote wound healing
• Relieve pain or decrease its intensity
• Sensorit/neuronal effects of sunbeam like light on mood disorders
• Counter-irritation according to Melzack and Wall (Gate control - explain)
• Cutivisceral reflec mediated through Head's zones

FIELDS OF APPLICATION

• WOUND HEALING
• PAIN TREATMENT
• DERMATOLOGICAL DISORDERS AND SKIN PROBLEMS
• SEASONAL AFFECTIVE DISORDER (SAD)
• IN PEDIATRICS
• IN NEWBORNS

WOUND HEALING

• Wound healing after trauma (injries)
• Burns
• Grafting
• Wound healing after operations
• Venous leg ulcers
• Decubitus (pressure ulcers)

PAIN TREATMENT

• Rheumatology
  • Osteoarthrisits
  • Rheumatoid arthritis (chronic)
  • Arthoses
• Physiotherapy
  • low back pain
  • shoulder and neck pain
  • carpal tunnel syndrome
  • scar tissue
  • musculoskeletal injuries
• Sports Medicine

Soft tissue injuries of muscles, tendons and ligaments like

• muscle spasm
• etndonitis
• sprains, strains, contusions
• desmorrhexis and muorrhexis (ligament and msucle tears)
• epicondylitis (tennis elbow)

Dermatological Disorders and Skin Problems

• Atopic dermatitus
• Psoriasis
• Herpes simplex
• Herpes zoster
• Superficial bacterial infections
• Acne
• Acne rosacea
• Mucosal lesions

Seasona Affective Disorders (SAD 'Winter depression)

Winter depression symptoms are chronic fatigue syndrome, lowered motivation, increased need for sleep, astenic conditions

Illnesses in children

• Skin diseases
• Endogenous eczema
• Upper respiratory tract infnections
• Allergic respoiratory diseases
• Pediatric musculoskeletal disorders and neurologial disorders and deficinces

Illnesses in newborn babies

• Dermal affections such as phlebitis, decubitus, intertrigo

Well-being

The BIOPTRON Light Therapy can also successfully be integreated in different applications in well-being

Selection fo images

Application

User-friendly for everyone

Images

1. Clean the area which you wish to treat (any dressing or medation should be removed before treatment)
2. Relax and start with the treatment

During the treatment

• Keep a distance of about 10 cm ( inches) to the treated area
• Direct eh lilght ebam onto the treated area while keeps a right angle of 90 degrees
• Dop not move the light beam during treatment

Application

• Aply the BIOPTRON Light Therapy in general for approxiamtely 4-10 minutes
• Depending on the indciation, we recommend to apply the treatment one or two times a day )for example in the moring and in the evening)

   3. Repeat the above points for each area on the body to be treated

   4. Unplug the device after use

For detailed information please see the operating instructions

Benefits of BIOPTRON Light Therapy

• Natural therapy
• Wide range of applications
• Many years of expereince
• No known side effecs
• Simple handling
• Short treatment times
• Economical threapy
• Maintenance free devices

For ue at home and in clinical and hospital settings