Skin tolerance

TSM supports are made from an innovative material developed over many years of development work which consists of "neoprene" (synthetic rubber) in various thicknesses (insulating layer) covered with fabric on both sides (synthetic fiber lining fabric; synthetic fiber/cotton blend knit fabric on the outside).
The chemical composition of the raw materials, including any additives, and of the knit fabrics, is a closely guarded commercial secret because this absolutely unique process uses new substances which are gentle on the skin, resulting in a neoprene raw material which is particularly suitable for medical applications. Details of chemical composition thus cannot be provided.

Known risk factors which may possibly arise during use of conventional neoprene products can be virtually completely ruled out. On the basis of the information supplied by the neoprene manufacturer and our many years of experience TSM supports have the following distinguishing features:

1. The synthetic rubber produced as the starting material has been subjected to continuous quality control for many years and complies with the most recent amendments to the German consumer article regulations (BGVO).

2. Unique, state of the art processing technologies ensure optimum molecular crosslinking in the raw material compounds which means that, once the compounds are vulcanized, the release of harmful substances is largely prevented.

3. There is thus virtually no risk from aromatic amines.

4. No "azodicarbonamide" blowing agents, which are very often used to produce the cells in the rubber, are used, so avoiding the skin irritation/sensitization which they may cause.

5. The knit fabrics used for lining TSM supports do not contain any "azo" dyes.

6. The lining fabric we have developed for TSM supports moreover ensures improved dissipation of moisture and heat, which means that any skin irritation or softening is extremely rare.

7. When new, the supports have a slight "nitro" odor from the adhesives used in production, but this disappears after a few washes, after which the supports should be odorless.

8. TSM supports have been used for many years not only in medical applications but also in amateur and, in particular, professional sports and we have never yet received any complaints due to skin reactions. It is, however, essential to care for the supports properly by complying with the instructions for use, including the washing instructions.

 

 

Tabular summary of the results of in vitro cytotoxicity testing and chemical (GC/MS) analysis of TSM/MSB neoprene supports and common competitor products. (as at May 2009)

Bandagentyp

TSM -
Bandage

TSM -
Bandage

MSB -
Bandage

Neopren-
Bandage A

Neopren-
Bandage B

Neopren-
Bandage C

Neopren-
Bandage D

Neopren
-Bandage E

Testextrakt

Wachstumshemmung %

100,0 % v/v

39

47

66

99

98

98

97

99

66,7 % v/v

14

13

19

99

98

32

95

69

44,4 % v/v

9

2

7

99

98

16

94

17

29,6 % v/v

1

2

6

97

27

7

46

9

19,8 % v/v

0

0

6

62

9

1

37

2

13,2 % v/v

0

2

0

36

1

1

21

0

Explanatory notes:

The material tested is considered cytotoxic under the legally stipulated test conditions if significant quantities of cytotoxic substances are released from the material under test (resulting in inhibition of more than approx. 30%), i.e. all supports which inhibit growth by more than approx. 30% are deemed to be cytotoxic at the particular dilution of the stated test extract (regions shaded in red). In accordance with German law on medicines (the MPG or Medizin-Produkte-Gesetz) and the EC directive 93/42 EEC, and due to health risks, these materials may not be used as supports nor placed on the market as medical aids. This also applies to personal protection equipment which falls under the EC directive 89/686/EEC and also includes sport supports.

II. Interpretation of the measurements (cytotoxicity measurements in general): For the TSM and MSB supports (both from AET GmbH), no cytotoxic effects occur even at moderate dilutions, whereas for some competing products, cytotoxic activity is maintained at the same level even at high dilutions. Cell damage may occur in everyday use in a highly dilute extract (13,2 through 29,6 v/v) if skin microinjuries, grazes, injuries due to external influences or even due to abrasion by the support itself (for example in the crook of the elbow or knee) occur in the area of skin covered by the support.

Thus, the competing products A and D constitute a potential allergy or health risk, unlike the TSM/MSB supports.

TSM has sponsored for 20 years different sports associations

Actively we support associations in different sports. The performances of the sportsmen give impulses to our work.

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You may contact us directly:

Tel:  08752-86140

Mail: info@aetgmbh.de

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