Product Information: Instruments a schilke -+ Power eficnt high evel dsinfecant or ele endoscopes dort bet sentient. gigasept® PA gigasept® PA Ata glance s@ unique peracetic acd formulation Product Data 1@ broad microbiological effectiveness Composition © aldehyde free Generator: 1009 of algaset* PA contains 3.03 Hydrogen peroxide, ‘= contains no acetic acid corrosion bors and tabling agents. = pit near neural Acthatr Aceyapolactam,Popanol-2,Explent {© highly improved material compatibilty compared to standard peracetic acid formulations ‘Cherical phys data: Presentation / Accessories Generator satnatar: igasept PA aval inthe following format: panne sugoew | eperce uaa Benty torte ooergc aon one Product PackSizeGateSae PoductCode) —Ranmabity on tomate Sarit) gyn stone « Grr Achat stim _2astve oss Formulation The Product Peracetic aid based products normaly contin acetic acid walla {Gigasept” PA i 9 unique patented formulation, designed specicaly for peraceticacd. Due to gigasept* PA unique PHERA® System there is the disinfection ofheat sensitive mecical devices suchas fibre opsicand no acetic acid. Acetic acid has 2 low (acd pH which can Increase the Video endoscopes. The formulation contains no aldehydes and althouch _pessblity of corosion. based on peracetic acid, gigatept® PA formulation ilikeno other peracetic acid based product on the matket, ‘Whats the PHERAT Systern? ‘The broad microbiological spectrum of gigasept* PA covers all micro a set soulmate tnghinendeeretetverarerenontas (ill : truedea pecten hese tre ep Pi nse cectlogy dpe a huge mprowent meeal eompatsity I Lambie ean mate entra sat Pera which her cate Ae eae instruments have to be disinfected. a as cima htasheen eran ntedanishomtobeompntle (i Te nadietneednnncesr al r Chea nena . pice ese mte | bie)gigasept® PA PHERA System ery Caprolactam — a Near Neutral pH Non Corrosive Existing peracetic acid products (Example) rere eae Low pH (Acie) Corrosive The benefits that this formulation has over the ‘stander peracetic ald based products ae extensive [Acetic ald gives stand formulations their vinegary odour and the product particularly low pH. Ths low pH is one of the reasons why peracetic acid products have had such a bad reputation with regard ‘to material compatibliy. As the clagram shows above, igasept® PA ‘contains no acetic aid. As a consequence gigatept? PA has a pH neutral ‘which in turn vastly improves the products material compaisity properties and also ernoves the inegary odour. Unik Aldehyde and 2% Glutealdehyde based products, ‘igasept® PA has no Maximum Exposure Limits (MEL| imposed. ‘while Peraceticacié has no Occupational Exposure Standard (OES) hydrogen peroxide does, however tests have shown levels were so low that they were underectable by current techaology. Microbiological Effectiveness loasepr® PAs designed to offer maximum microbiological fectveness ‘This made possible bythe synergistic elect produced by the unique combination of active ingredients, resulting in a broad spectrum of aetivy Micro- Organism Contact time Becria Fang vines Spas torn ecb beans IS letrencoscopes| ‘igatept* PA has been tested atthe leading institutes throughout ‘the world including the Hospital Infection Research Laboratory"in Birmingham by C. Bradley and J. Babb. ‘Their est show the following results. Contact Time Neat 50% Dittion 1500 ppm PAA 750ppm PAA lean ity Clean ity omeutesculenge 75714878778 ‘min kes aa Sma 7 ms 47308 20min 7 bas 1 vas amin 257 bas 153 24s Spores and final dsinfection = 10 minutos Contact Time Neat 60% Dilution 1500 pprn PAA 00pm PhA een Dirty Clean iry mires Calenge 831 an an tn 2 atm] min sot 2s fast orn Ne as iSmin ds ssn Sat so. 20min Ss1_ ssi ssst ost Mycobacterium tuberculosis Le Bronchoscopes = 15 minutesMethods / Instructions for Use Remove the activator bottle from the 5 lives canister, add the entie contentsto the main canister, tansfer activated Solution into the machine or disinfection bath and walt 30 minutes before first use. “The activated solution is active for 7 days and can be tested using Gigasept® PA test strips. In cases of heavy solling, eatier renewal solution is recommend, Always ensure complete wetting ofthe surfaces. immerse hollow objects in such a way that ar escapes completely from the lumen. ‘ter the necessary cantact ime rince carefully with stereo fered water before re-use When using gigasept”PAin automated and semiautomated machines, the solution i effective fr upto 40 cycles ‘over? days or 16 cycles over 4 days. Confirm with test strips as below. Un-used activated solution kept in the original container with ts i on, ‘an be kept fr upto 20 days and then used as above, Test Stipe ‘When the stip tums black > 900 ppm of PAA) the solution I effective and canbe reusc. If the strip does not change colour the solution eno longer effective and needs tobe changed, CChecking ofthe Effectiveness ofthe Solution with a Control Strip Wiener Labelling in Accordance with the Dangerous Preparations Directive Generator 5 lite canister: Hazard symbol: NONE sx Keep out ofthe reach of ciliven sz: Keepin coal place 524/525: Avoid contact with skin and eyes 826 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice sr Wear suitable gloves. Activator Hazard Symbol F:_ Highly Flammable Xn: Harmful its Highly ammable a2: Harmful if swallowed R36: Iritauing to eyes 32: Keep ut ofthe reach of children S16: Keep away from sources af ignition, No smoking 524/825: Avoid contact with skin and eyes, 526: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice S37: ‘Wear suitable gloves. Special Notes ‘The accident prevention regulation stipulates that gloves must bbe worn when handling disinfectants not intended forthe skin. Do not store at temperatures >= 254C for long periods Do not use the product after the expiry date, Environmental Information Schollebfayr has DIN EN 50 8001 and DIN EN 46001 certfication (Peg. No. 4567-01) and has a validated envrcnmental management system in accordance with £co Audit Regulation (Reg, No, DE-S-1S0 (0003) and is014001 Ecological Information Cigasept® PA presents no dangerous effet forthe environment. “The solution blodegredes easly. Activate solutions may be discharged, in waste water systems. Gigasept” PA iseadly and completely biotegredable'(Test method OECD 3010).BODE-SCIENCE-COMPETENCE Korsolex PAA Korsolex PAA-Activator ents y a Ready-to-use disinfectant based on peracetic acid with comprehensive efficacy for flexible endoscopes and heat-sensitive instruments.Product properties For the secure disinfection of heatsensitve mecical evices ‘ready-to-use; easy to apply ‘m ithoutaldetydes ‘mbases on peracetic act ‘= highevel disinfection Composition “The ready-touse basic soldion (Heshiy acivete) contains 1200 ppm of peracetic acd the concentration decreases during application and has to be checked regularly with ‘he ald of Korsolex® PAA Test test slicks. yuh @ peracetic acid concentration of at least 200 ppm Korsolex® PAA remains efective against the entre ‘microbiological spectrum, Microbiological activities Bactereidal, _yeasticdal, fungicidal, mmycobactercdal, sporcial, virucidal Directions for use Before placing the medical devices inthe Korsolex” PAA solution for disinfection, thoroughly clean them in a cleaning soluton / pre-disinfecion solution, All mecical ‘vioes have tobe free from organic residues. tuberculocdal, ‘The cleaning is of vital importance, as residues infuence the sclive ingredients stablly and result in is early decomposition. ‘Thoroughy rinse Insrumenis with water between cleaning ‘and diinfocton Preparation of the use-solution Pour the Korsolex® PAA-Actvator conoantrateffom the ‘small botle into the large canister (Korsolex” PAA) directly before the first-tene application, Wear suitable gloves and eye protection Shake the prepared use-solution wel in order to activate the solution evenly. Pour fe entre Use-solton into the dlsinfecton bath; aferwards itis ready for uso. ‘The prepared, uncontaminated use-solution hes a ‘maximum standing time of § deys ~ stored in the closed disinfection bath. Date end time of the preparetion should be writen down, Up to 50 leaned flexible endoscopes may be disinfected inthe solution. Aer the exposure time, medical devices have to be nsec with water of atleast crinkng water quay Important Check peracetic acid, concentration in the solution with the aid of Korsolex® PAA Test after breaks, longer stancing times, increased insertion of medical devices and before starting @ workday. ‘BODE-SCIENCE-COMPETENCE Dip test stick nto solution for 1 second. After 10 seconds (max. 15 seconds) you can read the test result cirecty ofthe test sick ‘An regular or unbalanced coloring ingicates_an insufficient concentration (also see Korsolex” PAA Test manu). Principle Peracetic acid is @ wel-known and longsed active Ingredient, which possesses a broad spectrum of effect With lis strong oxidative power, peracetic acid is a universal disinfectant that can be suocesstuly used against all groups of microorganisms, also against spore- forming bacteria and viruses. ‘The peracetic aci's active oxygen is spit oft, acetic acd develops and the active ingredients released, ‘After the preparation, the solution reaches 2 chemical ‘balance in a material-iendly pH range. The resuling slablized system provides @ prolonged standing time and guarantoos a broad spectrum of effect ‘as well 26 a good material compatbliy, particularly for flexible endoscopes. Suitable for ‘= flexible endoscopes, anesthesia materials end surgical instuments ‘= thermoplastic and elastomer Not suitable for ‘= surgical instruments with hard metal inlays instruments with anodizes parts "to holders containing titanium "contaminated instruments Dosage Ince instureris inlo the disinfection bath scluion completely Bactericidal ENIS727) Fungicisal EN 13628) ‘Yeastcidal (EN 19624) Virucial (EN 14878) Mycobactencidal EN 14348) “Tuberculocidal (EN 14348) Sporicdal (NF T'72.230/231) Listing Magical devico in terms of the Medical Device Directive (woo).‘Chemical-physical data Korsolex PAA Anpearance: piv sluon: Densiy ‘hid, eoloross approx. 11.6 1.0gtan* Korsolox Activator Appearance: H value solution, Densiy, Aid, colores approx. 33 119 g/cm? Mixture: ‘Appearance: H valve ~ solution: Densiy: Presentation Korsolex® PAA (with activator) Package Unit Sitercarister canisters ‘uid, colortess approx 82 approx. 1.0 giom* Accessories ‘Test sticks for poracetic acid for Korsolex® PAA Test Package Unit 100 sicks G tubes /box Hazard labeling Korsolex® PAA: . Korsolex® PAA (Activator): © Corrosive, Contin: Hydrogen peroxide solution, peracetic acd. Harmful by Iialaion and if swallowed. Causes ums. Intaing to respratory system. Keep cortaner Hotty closed in a cool place. Keep awey irom metals. Keep away fom flammable fotganic substances. In case of contact with eyes, rnse Immediately with plenty of water and seek medical advice. Wear stable protective clothing, gloves. and eye/oos protection. In case of accident or if you feel unwell, seek ‘edical advice immeciatly (show the lable where possible). Deerieeter mae ee Se ede eee Ne ere posnep tre} (poo cron Suna Sny BODE-SCIENCE-COMPETENCE Poracote aid toncentation ecoseary for efeacy acter sctvty Pseusoronse senginoss ‘Stahfooceus Enterococcus hae Yeasucea! set 20% 860 pom) 20% (360 pom) 20% (360 per) canisters (960 pe Fungicidal ctv Asgergus niger “oberelecies oy £0% (60 pom) oot Mycota ciety Mh torae ond Mycobscenury mum Vicia ety Aen vise Polo wine ‘Spill acy aac subele ana [sects cous 60%0720 ppm) 60% (720 pm) 70% (840 ppm) 75% (900 ppm) 753% (900 ppm) 20% (7209pm) 4100 % = 1200 ppm peracatc acid in the ready-touse Korsolex® PAA solution 7 % = 900 ppm peracetic acd, limit for determining the Concentation_n th ready-to-use Korsolex® PAA solution with Korsolex® PAA TestAreas of application For instantly checking the peracetic acid content in a Korsolex® PAA disinfection bath. Directions for use "= Dally application of the test sticks for monitoring the disinfection actvily of Korsolex® PAA in. the ‘isinfection bath. The mantoring takes place at the beginning of each use, after breaks and, In case of Intensive use, every 4 hours = Completely dip the test stc’s absorbent tip into the ‘lsinfection solution for 1 secon. After dipping, remove rests of the disinfection solution by sightly shaking the test stip. '™ Read off he result after 10 seconds. Test stripe may not be read anymore after more than 15 seconds! Storage conditions for the test sticks |= The fest strips (originally packed) havea storage ite of 24: months and can be slared al room temperature or in tha fridge ‘Immediately close tube again attr withcrawing @ test stipe. Opened and re:ciosed tubes are likewise stable for 24 months. They are stored at room temperature, "Make sure the tube is tightly closed fier using test sticks '§ Do not expose test strips to direct sunlight. Presentation “Test sticks for peracetic acid for Korsolax® PAA Test Package Unit | 400 sticks {6 tubes / box BODE-SCIENCE-COMPETENCE CONFORM (consistent coloring; color may differ) ‘A'CONFORM tost result indicates thatthe disinfection bath’s peracetic acid content exceads 900 ppm and may continued fo be used, NOT CONFORM ‘A "NOT CONFORM! test result indicstes that the disinfection bath's peracetic acid content fell below 800 ‘pom, The bath has to be exchanged,BODE-SCIENCE-COMPETENCE Stability of the disinfection bath Course of bath stabil without insertion of instruments, Concentration of peracetic acid 1300 1200 88 Concentration [ppm] 3 3 60 80 Time (hours) Stability of the disinfection bath — survey according to the number of reprocessed endoscopes Course of bath stabilty depending on cycles of reprocessed endoscopes. Concentration of peracetic aca Concentration [ppm] 20 30 40 Number of reprocessing cycles BODE CHEMIE HAMBURG : Germany Melanchthonstrafe 27 - 22525 Hamburg Tel. (+49-40) 5 40 06-0 « Fax -200 ‘www.bode-chemie.com -info@bode-chamio. doRecherche de Produits par nom 120-9 Produits Recherche par nom) Recherche pat usage Recherche daborée Sélectionner un produit DYNACIDE PA Imprimer la fiche Produit Imprimer la fiche Produit et les fiches Fournisseur DYNACIDE PA Créé 16/01/2002 et remis a jour le 04/09/2009. Fiche validée par un expert le 30/10/2002. Usages annoneés par le(s) fournisseur(s) : - Désinfectant pour DM Liste Positive Désinfectants : 01/06/2009 D : Produits pour la désinfection du matériel thermosensible Fournisseur(s) : - RIVADIS , Producteur Distributeur Classes des principes actifs : - ACIDE PERACETIQUE - AGENT ANTICORROSION - TENSIOACTIF NON IONIQUE, Détail des principes actifs (non exhaustif) : - 10332-33-9 ; Perboric acid, sodium salt, monohydrate Indications : Désinfectant a froid pour I'instrumentation médico-chirurgicale et pour le matériel thermosensible. Dilution : 60,5 g (une dose de 90 mL) / 5 L. ‘Non commercialisé en secteur dentaire http://prodhybase.chu-lyon.fr/produit/produitasp 2010/02/22Recherche de Produits par nom WIR pH: 7 +11 (produit dilué 4 1,21 %m/V). Commentaires : - Incompatibilité : alliage cuivreux (contact prolongé).. - Durée de trempage = 15 mi - Durée de validité du bain = 4 heures d'utilisation réelle (aprés préparation du bain) (10 endoscopes maximum). = Conditions opératoires : stockage < 25°C avant utilisation, température de l'eau de dilution < 30°C et de la pice au cours de l'utilisation < 25°C. Purge préalable des endoscopes. - NF EN 1275 / NF T 72-202 / fongicidie (complete) / version 1997 20°C - 5 min - 0,14 % - NE EN 1040/ NF T 72-152 / bactéricidie / version 1997 20°C - 5 min - 0,035 % Risque(s) : (directives 67/548/CEE et 1999/4S/CE) - Irritant peau - Irritant yeux et muqueuses -Nocif Sécurité et protection - Port de gants appropriés, masque, lunettes de protection. individuelle : - Local ventilé. - Maintien des bacs fermés en dehors des manipulations. Présentation : Sachet unitaire 60,5 g. Seau 2 Kg. Imprimer la fiche Produit 2 Imprimer la fiche Produit et les fiches Fournisseur ” Dernitr a de Ic 7 Jerniére mise jour de la Promoteurs xii base : 13/02/2010 466 produits et 73 fournisseurs, http://prodhybase.chu-lyon.fr/produit/produit.asp 2010/02/22PHAGONEUTRE + Les points forts : + Actif sur les biofilms * Biocide a 0,4% dés 5 minutes 4g Détergent - Désinfectant pour la pré-désinfection et le nettoyage des dispositifs médicaux : matériel, endoscopes. INSTRUMENTS PHAGOGENE (=) C€ bhttpiiwwaw phagogene.comPHAGONEUTRE + LABORATOIRES PHAGOGENE DEC Identifier le bac de traitement par une étiquette * Couvrir les bacs de traitement apres Ammonium quatemaire + + Norme NF S 94-402-1 introduction du matériel Nature chimique du principe | [Expertises complémentaires actif du produit Biguanide « Agents co-actits. décembre 1992 : Produit non Conserver le bain non utilisé corrosif dans les conditions de aU_ maximum 96 heures * Domaine diutilisationdu] test. Consulter préalablement la Notice d'instruction du matériel + Etude de compatibilité avec traité pour verifier les les endoscopes souples = informations relatives a la Détergent - Désinfectant pour Produit non corrosif vis A vis compatibilité avec les. la pré-désinfection “et le des parties métalliques et non —_désinfectants. nettoyage des disposi ~—_agressif vis a vis de optique produit as matériel, et _ des différentes parties Précautions d’emploi ‘endoscopes. synthétiques. Concentration d'utilisation | * Etude de compatibilité avec Ne pas avaler + Conserver du produit divers D.M. : Consulter le uniquement dans le récipient Dossier scientifique (DS). dorigine, a abri de la lumiére +0,4% : * Conserver et utiliser aux eee eer aa conditions normales de. : eee température + Ne pas réutiiser Het ee ae Texpertise Gormande (5). Temballage + Utliser en usage ; exteme + Eliminer les déchets Aspect Liquide limpide Mode d'emploi en tenant compte des incolore * pH : (0,4 % - eau du restrictions réglementaires ou réseau) : 7.7405 locales relatives & la gestion Diluer en eau froide ouen eau des déchets infectieux ou & Retivité antimicroblenne du] chaude a 0,4% soit verser en caraciére__dangereux produit premier l'eau, puis un sachet consulter_ le Responsable dose / 51 ou une mesure dose Sécurité de votre de 20 mi/5idieau-Immerger —_établissement + Consulter la et nettoyer les instruments + Fiche de données de sécurité. Respecter un temps de Bactéries : Norme NF EN contact de 5 minutes minimum Conditionnement 1040 «Nome NF T 72-179 9W Selon protocole + Brosser si ditions de saleté + N nécessaire + Rincer avec de Feit eaten \oree Teau puis sterliser ou Carton de 10 x ‘litre « Carton Activité biocide en 5 minutes. Conditions de saleté+ désinfecter (Voir protocole). ec Bat gir de ea a . Méthodol BACTEC varton de idons de res Meberibes a Recommandations avec pompe de 20 mi. Méthodologie selon NF T 72- (al Gianna 190: voir Dossier Scientifique’ Ne pas _mélanger avec dans cette fiche ne sont pas Fungi : Méthodologie NF EN qautres produits - Usage _contractuelles. Le fabricant se eee Manuel ou bac @ uitrasons + réserve le droit de les mocifier Virus : Méthodologie vs HIV, — Renouveler aprés 24 heures pour améliorer les produits HBV =: voir Dossier (France: bain & usage unique dans lintérét de lutiisateur. Scientifique. dans les conditions de la 1361 -Juin 06-Ed1 circulaire DGS 2001/138) Laboratoires Phagogéne DEC BP 201 06272 Villeneuve-Loubet Hopital +33 4.9208 6111 Santé &, Distribution +33 4 92 08 61 06 hopltal@phagogene com - distribution @phagogene.com Sitge social : BP 192 - SIRET 350 269 304 00027