Applied Silicone Corporation's Implant Grade Responsive Gel System is a two part dimethyl silicone formulation designed for gel filled medical devices which require a soft form retaining shape that has superior resistance to rupture or gel fragmentation and migration.  This product is equivalent to and has replaced Applied Silicone part number 40125, High Strength Responsive Silicone Gel System.

The platinum addition cured product is provided in two parts which are mixed in a ratio of about 3:1.  Cure is achieved at elevated temperature at 165°C.  The gel can be cured into virtually any shape or thickness with no cure by products.

This material is intended for long term medical contact or implantation.  Manufacturing of this material is performed under stringent quality control that is fully traceable per ISO 9001 certified procedures.

Confirmatory bio-testing per ISO 10993 for this material have been completed.  The user of this material must independently determine that any medical product incorporating this material is safe and effective.

Applied Silicone recommends that product designers using this material contact Applied Silicone Corporation's Regulatory Affairs to determine what test results are available before incorporating this material into a medical device.   

This product was designed to be mixed in the ratio of 1.0 parts by weight crosslinker to 3.0 parts by weight base.  The firmness of the cured gel may be increased, i.e., a lower penetration value, by increasing the proportion of crosslinker in the mix.  The firmness may be decreased, i.e., a high penetration value, by decreasing the proportion of crosslinker in the mix.  Applied Silicone can adjust gel firmness to meet customer requirements.  Excess crosslinker will lead to reduce gel fracture strength.

Due to high permeability and swell of dimethyl silicone elastomers, when used with this gel product a fluorosilicone elastomer, such as Applied's PN 40130 is recommended for gel component diffusion control.

Weigh out the respective desired quantities of base and crosslinker.  Combine and mix thoroughly.  Do not mix more than can be used in 24 hours.

The mixture is then dispensed to fill the desired form.  As particular applications warrant and permit, the mixture may be placed under vacuum to consolidate and remove air bubbles before, or after, the form filling process.

The mixture is normally cured with heat in a convection type oven, typical cure is 3.5  hours at 165°C.  Extended high temperature may cause very slight yellowing.  Because dimethyl silicone has a high thermal expansion coefficient, high temperature cure cycles may lead to a distorted shape when cooled at room temperature.  For optimum for preservation, a lower temperature is desired.  If high heat is required for sterilization, cure at low temperature to set the shape and then increase temperature.  Once the shape is set, it should return to that shape when thermal stresses are removed.

A Material Safety Data Sheet (MSDS) is supplied with shipment.  Contact with the eyes may cause temporary eye discomfort.

Accurate measuring and complete mixing are important factors in obtaining consistent results.

Contamination by trace amounts of various compounds can result in an unreliable cure and/or yellowing of the gel.  Therefore, it is important to avoid contamination of the gel and any surface to which the gel is exposed.  All metering and mixing equipment, as well as any form into which the material is introduced, should be thoroughly clean.  Organic rubbers often contain compounds which can interfere with the cure of the gel and should be avoided.

Latex gloves should never be used while fabricating or handling products or components utilizing this product.

Packaging is available in 1 gallon, 5 gallon and 55 gallon quantities.  This material should be stored under cool and dry conditions.  Containers should be sealed to avoid contamination.

Suggested retest is at six months from the date of shipment.

DISCLAIMER 
 
Applied Silicone Corporation warrants that this product meets applicable descriptions and specifications for a period of six months from shipment.  No other warranties, expressed or implied, are intended.  This product was designed for sophisticated users.  The user must carefully review literature for uses where adverse effects are reported for certain applications of silicone in medical devices.  The user of this material must independently determine that any product incorporating this material is safe and effective.  The user of this material must thoroughly test any application consistent with industry requirements and/or standards.  Applied Silicone Corporation disclaims any expressed or implied warranty against the infringement of any patent.  Any suggestion of use by Applied Silicone should not be taken as inducement to infringe on any particular patent. 

 Revised 11.08.07