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Product Information Instrument Disinfection

Ready-to-use high level disinfectant for the disinfection of flexible endoscopes and medical instruments 0297

gigasept PAA
®
Our plus aldehyde free broad microbiological effectiveness prevention of biofilm ready-to-use Forms of supply/ Packaging units gigasept® PAA is available in the following formats
Product / Accessories gigasept PAA gigasept PAA test strips Key Pack Size 5 Ltr 50 strips in a single tube 1 unit Case Size 4 x 5 Ltr 1 unit Product Code 195751 195704 135810

Chemical – Physical data
Appearance: pH: Density at 20°C: clear liquid, colourless appr. 4 1,02 g/ml

Microbiological Effectiveness gigasept® PAA is effective against
Bacteria Mycobacterium terrae Fungi Spores Viruses EN 1040, EN 13727 (clean conditions) EN 14348 EN 1275, EN 13624 EN 14347 (clean conditions) EN 14476 5 min 5 min 5 min 5 min 5 min

Instructions for use Areas of application gigasept® PAA is a unique patented formulation, designed specifically for manual or semiautomated disinfection/processing of pre-cleaned flexible endoscopes, ophtalmological equipment, surgical instruments made of stainless steel and heat sensitive medical devices. gigasept® PAA is active immediately and stable over 7 days or 50 cycles. The solution can be tested using gigasept® PAA test stripes. Always ensure the pre-cleaning of the endoscope and a complete wetting of the surfaces. Immerse hollow objects in such a way that air escapes completely from the lumen. After the necessary contact time rinse carefully with sterile or filtered water before re-use. Do not exeed the recommended contact time.

Product data
Composition: 100g of gigasept® PAA contains: 0,1 g Peracetic acid Other ingredients: corrosion inhibitors, surfactants, stabilising agents, excipients

gigasept® PAA
Use of gigasept® PAA test strips: gigasept® PAA test strips turns black or dark blue if the solution is effective. With no change of colour or only partly coloration of the strips the solution is no longer effective and need to be changed. Dip test strip in the solution for 1 second. Shake off the excess liquid. Check the colour in the test zone after 10 seconds.

Special notes gigasept® PAA is not classified as a dangerous formulation by ingestion (Test OECD 401) or irritation to skin (OECD 404). gigasept® PAA does not generate toxic vapour – the average exposure limit of the ingredients is respected. gigasept® PAA is not sensitising (Test OECD 406). Gloves must be worn when handling disinfectants not intended for the skin. Do not store at temperatures > 30ºC for long periods. Do not use the product after the expiry date.

Environmental Information schülke manufactures products economically and with advanced, safe and environmentally friendly production processes while at the same time maintaining our high quality standards.
When the strip turns to black, the solution is effctive. With no change of colour to the strip, solution needs to be changed.

Expert Opinion and Information
For an overview of our products containing gigasept® PAA, please refer to our website www.schuelke.com Should you have any further questions: Customer Care Phone: +49 (0)40 521 00-666 E-mail: info@schuelke.com

Ignore colour changes after 15 seconds.

Material Compatibility
Incompatible materials: iron, toolsteel, aluminium, platinum, nickel-/ chromeplated or non ferrous metal alloys parts (e.g. copper and brass) Compatible materials: (limited to the maximum contact time; obligatory rinse after contact) polycarbonate, polyurethane, silicone, polysulfone, polyamide, polyester, polystyrene

Interactions
Avoid the mixing of gigasept® PAA with other products (cleaner, disinfectants), particularly with aldehydes or derivates of halogens (e.g. glutaral, sodium hypochlorite, etc.)

Labelling according to EC directives
39/I/07/10/B/Rako – This product information is not automatically updated. Schülke & Mayr Ges.m.b.H Seidengasse 9 1070 Wien, Austria Phone +43 (0) 1- 523 25 01 - 0 Fax +43 (0) 1- 523 25 01 - 60 office@schuelke.at

Xi Irritant. R41: Risk of serious damage to eyes. S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S39: Wear eye/face protection.

BIOXAL SA, 71100 Chalon sur Saône, France Schülke & Mayr GmbH 22840 Norderstedt, Germany Phone +49 (0) 40 - 521 00 - 0 Schülke & Mayr GmbH is certified according to DIN EN ISO 9001, DIN EN ISO 14001 Fax +49 (0) 40 - 521 00 - 318 and DIN EN ISO 13485 (Reg.-No. 004567-MP23) and has a validated environmental www.schuelke.com system in accordance with the Eco Audit Regulation (Reg.-No. DE-150-00003). mail@schuelke.com Schülke & Mayr UK Ltd. 1 Jenkin Road GB-Sheffield S9 1AT Phone +44 (0) 1142 - 54 35 - 00 Fax +44 (0) 1142 - 54 35 - 01 mail.uk@schuelke.com

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