Ortho 2000 Silicone

ORTHO 2000 FLUID SILICONE 300 ML

Ortho 2000 Fluid Silicone is a pink silicone elastomer specially designed for the manufacture of specialised orthoses and orthoplasties in podiatry.

Its fluid consistency allows it to be combined with textile supports such as bandages, gauze and tubular materials, facilitating the production of thin orthoses that retain good flexibility and strength.

It is particularly suitable for making protective sleeves, bunion protectors and metatarsal pads, as well as other orthoses that require adaptation using textile materials.

This silicone vulcanises at room temperature through a polycondensation reaction. When the Master-Cat catalyst is added, the silicone changes from its fluid state into an elastic and durable material.

Once vulcanised, it has a hardness of 10 Shore A, providing a flexible material for the manufacture of specialised podiatric orthoses.

INDICATIONS:

• Manufacture of specialised orthoses and orthoplasties in podiatry.
• Production of protective sleeves.
• Manufacture of bunion protectors.
• Production of metatarsal pads.
• Manufacture of orthoses by combining silicone with bandages, gauze and tubular materials.
• Production of extra-thin, flexible and durable orthoses.

FEATURES:

• Pink fluid silicone.
• Hardness of 10 Shore A once vulcanised.
• Vulcanises at room temperature through a polycondensation reaction.
• Transforms into an elastic and durable material when a catalyst is added.
• Can be combined with textile supports.
• Facilitates the manufacture of thin orthoses.
• Contains medical-grade medicinal oil.
• Complete vulcanisation after 24 hours.
• Supplied in a 300 ml container.

COMPOSITION:

• Silicone polymer.
• Medical-grade medicinal oil.
• Colourant.

PHYSICOCHEMICAL PROPERTIES:

• Appearance: fluid silicone.
• Colour: pink.
• Odour: characteristic.
• Hardness after vulcanisation: 10 Shore A.
• Density at 20 °C: 1.23 g/cm³.
• Flash point: above 200 °C.
• Water solubility: immiscible.

INSTRUCTIONS FOR USE:

The silicone must be worked on a plastic surface or silicone-coated paper.

1. Prepare the textile support: cut a piece of tubular material or gauze to the appropriate shape for the orthosis being made.
2. Prepare the silicone: pour the required amount of Ortho 2000 onto a sheet of silicone-coated paper or a plastic plate.
3. Add the catalyst: incorporate the appropriate amount of catalyst according to the instructions for use.
4. Mix: thoroughly knead the silicone together with the bandage or textile support.
5. Apply and shape: place the silicone and bandage mixture over the area where the orthosis is to be made and shape it until the desired form is achieved. Cover the area with plastic film.
6. Trim and refine: once the orthosis has been removed, wait approximately 10 minutes before trimming it and making any necessary adjustments.
7. Complete vulcanisation: the orthosis will be fully vulcanised after 24 hours.

PRECAUTIONS:

• Carefully control the amount of catalyst used.
• Observe the recommended mixing time to ensure proper vulcanisation.
• Consult the safety data sheet before using the product.

WARNINGS:

• Product intended exclusively for qualified personnel. Professional use only.
• Keep out of reach of children.
• In case of irritation, discontinue use.
• Read the safety data sheet to prevent possible accidents during handling.

PACKAGING AND REFERENCE:

• Ref. 10.006.4: Ortho 2000 Pink Fluid Silicone, 300 ml container.

CLASSIFICATION AND CERTIFICATIONS:

• Medical device: Class I.
• Marking: CE.
• Management system certifications: ISO 9001, ISO 14001 and ISO 13485.

STORAGE:

• Keep in its original packaging.
• Store in a cool, well-ventilated place.
• Storage temperature: between 5 and 30 °C.
• Protect from direct sunlight.