gigazyme® X·tra

• The ideal combination of high-quality enzymes (Protease = cutting proteins, Lipase = cutting fat, Amylase = cutting starch) and an innovative system of sufactants allows for excellent cleaning of thermostable and thermolabile instruments of any kind. The disinfecting properties of gigazyme® X·tra offer protection from contaminations with infectious pathogens such as bacteria, yeasts, and enveloped viruses (incl. HIV, HBV, HCV) for personnel and the environment.
  

gigazyme® X·tra is a concentrate and is diluted with cold water to produce the desired application concentration.
Dosage:
depending on the degree of effectiveness 0,5 % - 2 %.
Application example:
1 litre of a 2 % working solution corresponds to 980 ml of water and 20 ml of gigazyme® X•tra.
Place endoscopes and instruments for reprocessing in the gigazyme® X·tra solution immediately after use. Ensure complete covering of the surfaces, also of hollow instruments, and allow to take effect. Rinse all instruments thoroughly after cleaning, using water of at least drinking water quality, or preferably sterile distilled water or fully deionised water, to completely remove residues of the cleaning solution. Please follow the reprocessing recommendations of the instrument manufacturers. Renew the application solution every workday and if there is visible contamination. Do not mix gigazyme® X·tra with disinfectants and other cleaners. National regulations may require that cleaning and disinfection are carried out in two separate process steps. Not for final disinfection of semicritical and critical medical devices!
The following concentrations also apply for use in the ultrasonic bath.

gigasept PAA is effective against:

Efficacy	Concentration	Contact time
bactericidal EN13727, EN14561- dirty conditions	1% (10 ml/l)	30 min
bactericidal EN13727, EN14561- dirty conditions	2 % (20ml/l)	15 min
levurocidal EN13624, EN14562- dirty conditions	1% (10 ml/l)	30 min
levurocidal EN13624, EN14562- dirty conditions	2 % (20ml/l)	15 min
virucidal against enveloped viruses in accordance with DVV (German Registered Association for Combating Viral Diseases - dirty conditions	1 % (10ml/l)	30 min
virucidal against enveloped viruses in accordance with DVV (German Registered Association for Combating Viral Diseases - dirty conditions	2 % (20ml/l)	15 min

Composition:
100 g of gigazyme® X·tra contains the following active ingredients: 7.7 g Didecyldimethylammonium chloride, 0.4 g of Polyhexamethylene biguanide.
Contains Subtilisin, Polyhexamethylene biguanide. May produce an allergic reaction.
Labelling according to Directive (EC) No. 648/2004:
5 - 15 % non-ionic surfactants, enzymes, perfumes.

Chemical-physical data
Form:liquid
Color:green
Viscosity, dynamic:ca. 53 mPa*s
Density:ca. 1,08 g/cm3 / 20 °C
Flash point:ca. 52 °C / Method : DIN 53213, Part 1
pH:ca. 7,5 / 20 °C / concentrate

Always read the label and product information before use.
Medical lubricant gels (with or without local anesthetic effect) are often used during endoscopic examinations. When working solutions and concentrates of gigazyme® X·tra come into contact with such gels, there is the possibility of precipitations. This reaction can occur in principle with all products containing cationic disinfectant agents. Every product mixture is therefore to be avoided, and gel residues should be thoroughly washed off. Please ask our customer service team about which lubricant gels are compatible.

schülke manufactures products economically and with advanced, safe and environmentally friendly production processes while at the same time maintaining out high quality standards.