Safeguard your patients, staff and instruments

Transcription

1 Safeguard your patients, staff and instruments Automatic and manual reprocessing of instruments Instrument reprocessing

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3 Tailor made products for reprocessing of instruments At a glance Manual reprocessing 4 Automated reprocessing 4 We care for patient and staff safety 5 Manual reprocessing Stabimed 6 Helipur H plus N 8 Helipur 10 Helizyme 11 Cleaner N 12 Melseptomat G 13 Code of practice 14 Manual cleaning and disinfection step by step 15 Automated reprocessing Automated reprocessing 16 Helimatic Cleaner neutral 17 Helimatic Cleaner alcaline 18 Helimatic Neutralizer C 20 Helimatic Neutralizer forte 21 Helimatic Rinse neutral 22 Helimatic Latriniser 23 Helimatic Cleaner enzymatic 24 Helimatic Disinfectant 25 Heli-Dos 26 Special products for dentistry Tiutol dent 27 Further information B. Braun infection control portfolio at a glance 28 3

4 Concerted all elements of our infection control portfolio Manual reprocessing Heat resistant materials Heat sensitive materials Flexible endoscopes Cleaning Bactericidal Fungicidal Enveloped viruses (incl. HBV, HCV, HIV) Enveloped and nonenveloped viruses Page Stabimed 6 Helipur H plus N 8 Helipur 10 Helizyme 11 Cleaner N 12 Automated reprocessing Disinfection Cleaning Reprocessing of bedpans and urinals Final rinse aid Neutralizing Page Helimatic Cleaner neutral 17 Helimatic Cleaner alcaline 18 Helimatic Neutralizer C 20 Helimatic Neutralizer forte 21 Helimatic Rinse neutral 22 Helimatic Latriniser 23 Helimatic Cleaner enzymatic 24 Helimatic Disinfectant 25 4

5 We care for patient and staff safety... and for your valuable instruments Reusable invasive medical devices must be reprocessed using a validated cleaning and disinfection process prior to a validated sterilizing process to guarantee patient safety. Reprocessing is detailed, labor intensive, time-consuming and can be prone to errors. Each reusable medical device requires specific reprocessing steps or techniques appropriate for that device. The staff being responsible for the steps in the process need Access to the manufacturers instructions and proper training to learn how-to. Equipment (e.g. appropriately sized brushes) available for use. PPE, to protect themselves against biohazards or splashes of reprocessing agents. A used medical device is potentially dangerous. It can transmit infectious diseases e.g. in case of sharp injuries to the staff. But even a process state of the art, which guarantees patient and staff safety may damage your valuable surgical instruments / reusable medical devices. For decades B. Braun has developed and manufactured surgical instruments and reprocessing agents as well as offering a complete infection control portfolio including PPE. An optimized process using B. Braun products fulfills highest requirements regarding patient and staff safety resulting in a minimized amount of repair and maintenance costs. B. Braun offers a comprehensive portfolio of reprocessing products, service, training and consulting. In general Infection control plans MSDS Material Safety Data Sheets Dosing table and dosing aids Expert reports and certificates Stickers... and much more Automated reprocessing Process analysis and optimization, regarding cleaning, disinfection, consumption of reprocessing agents and batch time Validation of the cleaning and disinfection process Documentation Determining the ph-value in the cleaning step Chemical analysis of the water quality... and much more 5

6 Disinfection Stabimed Cleaning and disinfection of heat sensitive and heat resistant medical devices Disinfection D i s i n f e c t i o n Properties Stabimed Liquid concentrate based on alkyl-amine Aldehyde-free, phenol-free and QAC-free Recommended by Aesculap Fast and gentle reprocessing of reusable medical devices such as flexible or rigid endoscopes, anaesthetic equipment and other heat sensitive materials. Broad efficacy spectrum: bactericidal (incl. MRSA and TbB), fungicidal, virucidal against enveloped viruses (incl. HBV, HCB, HIV)1) and effective against Rota-, Polyoma- and Adenoviruses Can be used in ultrasonic baths Excellent cleaning properties, easily removes dried on blood and secretions Aldehyde-free, therefore non protein-fixing Economic: 0.5 % / 60 min., 2 % / 15 min. Diluted to 0.5 %, one litre concentrate gives 200 litres ready-to-use working solution 1) acc. RKI 01/2004 6

7 Disinfection St abime d cleaning and disinfection At a glancemicrobiological Effi cacy Effective and economic 2.0 % / 15 minutes Aldehyde-free, therefore non-protein-fixing Easily removes dried on blood Excellent material compatibility Can be used in ultrasonic baths For reprocessing of flexible endoscopes DGHM 1) / VAH 2) -listed, and included in the IHO-list 3) Instructions for use After soaking in ready-to-use Stabimed working solution, rinse the instruments thoroughly under cold running tap water. Perform the final rinse in demineralized or distilled water. Dry instruments with an absorbent, lint-free cloth towel. Prior to the first use of Stabimed the instrument bath shall be cleaned with water and Helizyme, to remove potenial residues of previously used products (in particular if aldehyde-based disinfectants have been used). Do not mix with aldehyde based products. Micro-organism Cleaning and disinfection of instruments acc. DGHM 1) / VAH 2) incl. Tb bacteria (M. terrae) 2.0 % 1.0 % 0.5 % Contact time 15 min. 30 min. 1 h 20 ml / L 10 ml / L 5 ml / L Enveloped viruses 1.0 % 5 min. 10 ml / L (incl. HBV, HCV, HIV) 4) Vaccinia-virus 0.5 % 5 min. 5 ml / L Rotavirus Polyomavirus Conc. 1.0 % 0.5 % 0.25 % 2.0 % 1.5 % 1.0 % 5 min. 15 min. 30 min. 15 min. 30 min. 1 h ml / L 10 ml / L 5 ml / L 2.5 ml / L 20 ml / L 15 ml / L 10 ml / L Adenovirus 2.0 % 1 h 20 ml / L Cleaning and disinfection in an 2.0 % 15 min. 20 ml / L ultrasonic bath Bactericidal acc. EN % 5 min. Fungicidal acc. EN % 5 min. (Candida albicans) Fungicidal acc. EN (Aspergillus brasiliensis, clean cond.) 0.5 % 1 h Unit of sale 100 ml bottle, 1000 ml bottle, 5 litre canistre Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): ca. 10 ca. 9 Density (20 C, g/cm 3 ): ca Appearance clear clear blue-green blue-green Aldehyde-free Stabimed Composition: 100 g Stabimed contains cocospropylene diamine 20.0 g, exipients: surfactants, solvents, complexing agents, corrosion inhibitors, solubilisers, perfume, colourants. Ingredients in accordance with the Regulations for Detergents EG 648/2004: % nonionic surfactants, < 5 % NTA, perfume (Limonene, Hexyl Cinnamal) Labelling in accordance with the Dangerous Substances Directive Corrosive Flammable. Harmful if swallowed. Causes severe burns. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing, gloves and eye/face protection. In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). Keep out of reach of children. Cautions Use disinfectants safely. 1) DGHM = German Society of Hygiene and Microbiology 2) VAH = Association of Applied Hygiene 3) 4) acc. RKI 01/2004 7

8 Disinfection H e l i p u r H plus N Disinfection of heat sensitve medical devices Disinfection D i s i n f e c t i o n Properties H elip ur H plus N Liquid concentrate with pleasant smell, aldehyde-based Free of formaldehyde Gentle reprocessing of rigid and flexible endoscopes, anaesthetic equipment and other heat sensitive material Broad efficacy spectrum: bactericidal (incl. MRSA and TbB), fungicidal, virucidal against enveloped viruses (incl. HBV, HCB, HIV) 1) and non-eveloped viruses Economically low ready-to-use working concentration: (1 % / 30 Min.; 1.5 % /15 Min. DGHM 2) / VAH 3) ) Can be used in ultrasonic baths 8

9 Disinfection Helipur H plus N for rigid and flexible endoscopes At a glance Highly effective Excellent material compatibility Virucidal RKI Free of formaldehyde For rigid and flexible endoscopes DGHM 2) - / VAH 3) -listed Instructions for use After disinfection rinse the instruments thoroughly under cold running tap water. Perform the final rinse in demineralized or distilled water. Use Helizyme or Cleaner N for cleaning of flexible endoscopes prior to disinfection. Visibly contaminated solutions shall be discarded. Do not mix with amine based products. Microbiological Effi cacy Micro-organism Disinfection of instruments acc. DGHM 2) / VAH 3) incl. Tb bacteria (M. terrae) 1.0 % 1.0 % 1.5 % Contact time 1 h 30 min. 15 min. 10 ml / L 10 ml / L 15 ml / L Virucidal: enveloped viruses 1.0 % 15 min. 10 ml / L (incl. HBV, HCV, HIV) 1) Virucidal, enveloped and nonenveloped virus 2.0 % 4.0 % 1 h 30 min. 20 ml / L 40 ml / L Vaccinia-virus 1.0 % 5 min. 10 ml / L Rotavirus 0.25 % 5 min. 2,5 ml / L 1.0 % 1 h 10 ml / L Polyomavirus 2.0 % 30 min. 20 ml / L Adenovirus 1.0 % 5 min. 10 ml / L Poliovirus Tuberculocidal Sporicidal EN (B. subtilis and B. cereus) Conc. 2.0 % 4.0 % 2.0 % 2.5 % 4.0 % 17 % 15 % 1 h 30 min. 1 h 30 min. 15 min. - 6 h - 8 h ml / L 20 ml / L 40 ml / L 20 ml / L 25 ml / L 40 ml / L 170 ml / L 150 ml / L Heavily soiled instruments must be precleaned under running tap water. Unit of sale 100 ml bottle, 1000 ml bottle, 5 litre canistre Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): ca. 4.5 ca. 5 Density (20 C, g / cm 3 ): ca Appearance green light-green Fully virucidal H e l i p u r H plus N Composition: 100 g solution contains: Glutaral 12.0 g, 2-Propanol 7.5 g, Ethylhexanol 0.5 g. Excipients: Ingredients in accordance with the Regulations for Detergents EG 648/ % anionic surfactants, < 5 % nonionic surfactants, Perfume (Limonene) Labelling in accordance with the Dangerous Substances Directive Corrosive Causes burns. Harmful by inhalation and if swallowed. May cause sensitization by inhalation and skin contact. Do not inhale vapour. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing, gloves and eye / face protection. In case of accident or if you feel unwell, seek medical advice immediately (show the label if possible). This material and its container must be disposed of in a safe way. Disposal information in safety data sheet. Keep out of reach of children. 1) acc. RKI 01/2004 2) DGHM = German Society of Hygiene and Microbiology 3) VAH = Association of Applied Hygiene 9

10 Disinfection H e l i p u r Cleaning and disinfection of heat resistant medical devices Helipur Cleaning and disinfection in one step Properties Helipur Highly effective liquid disinfection concentrate S uitable for surgical instruments made of stainless steel, glass and ceramics Cleaning and disinfection in one step; contaminated instruments can be soaked directly in the ready-to-use working solution. Manual pre-cleaning can be omitted. Aldehyde-free Economic Effective against bacteria (incl. MRSA and TbB), fungi and envelopes viruses (incl. HBV, HCV, HIV) and Polyoma- and Adenovirus. Can be used in ultrasonic baths D G H M 1) / VAH 3) - and RKI 4) -listed Microbiological Effi cacy Micro-organism Disinfection of instruments (incl. mycobacteria, yeasts; DGHM 09/2001 corr. EN 14561, EN 14562, EN 14563) Conc. 1.5 % 3.0 % Contact time 15 min. 5 min. ml / L 15 ml / L 30 ml / L Fungi (A. niger acc. EN 14562) 1.5 % 3 % 60 min. 15 min. 15 ml / L 30 ml / L Enveloped viruses 1.0 % 15 min. 10 ml / L (incl. HBV, HCV, HIV) 2) Polyomavirus 5) 1.5 % 5 min. 15 ml / L Adenovirus 6) 2.0 % 1 h 20 ml / L Caution H elip ur is not suitable for reprocessing heat sensitive materials, in particular flexible endoscopes. Instructions for use For further information see page 14. For professional use only. Unit of sale 100 ml bottle, 1000 ml bottle, 5 litre canistre Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): 11 ± 0,3 9.5 ± 0.5 Density (20 C, g/cm 3 ): ca Appearance red-brown Excellent cleaning H e l i p u r Composition 100 g solution contains Chlorocresol 8.5 g, Clorofen 4.8 g, Biphenyl-2-ol 4.0 g, anionic surfactants, aliphatic alcohols, complexing agents, solvents, corrosion inhibitors, perfume, clourants. 1) DGHM = German Society of Hygiene and Microbiology 2) limited virucidal activity, RKI 01/2004, DVV suspension test 10 Ingredients in accordance with the Regulations for Detergents EG 648/2004 >30 % anionic surfactants, <5 % phosphonates, perfume, colourants. (Benzyl Salicylate, Coumarin, Eugenol, Linalool) Labelling in accordance with the Dangerous Substances Directive: Flammable. Harmful in contact with skin and if swallowed. Irritating to skin. Risk of serious damage to eyes. May cause sensitization 3) VAH = Association of Applied Hygiene 4) RKI = Robert Koch-Institute by skin con tact. Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. In case of contact with eyes rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of in a safe way. Wear suitable protective clothing, gloves and eye/face protection. Avoid release to the environment. Refer to special instructions/safety data sheets. Keep out of reach of children. 5) DVV / RKI suspension test 6) EN 14476, DVV/RKI suspension test

11 Cleaning Helizyme Cleaning of flexible endoscopes and sensitive medical devices Helizyme enzymatic cleaner Properties Helizyme Excellent cleaning power For manual and semi-automatic cleaning of surgical instruments, rigid and flexible endoscopes Innovative combination of a ternary surfactant system with proteolytic enzymes Economically low ready-to-use working concentration. (1% / 5 min.) Has excellent cleaning power against contaminants containing proteins and lipids. Extraordinary effective biofilm remover (demonstrated efficacy by in-vitro tests) ph-neutral High material compatibilty May be used in an ultrasonic bath Removes dried on dirt Recommended by Aesculap to clean diamond cutters. Instructions for use 1 % (diluted with hand warm water). Soak instruments, ensure they are fully covered. Use suitable cleaning utensils. Exposure time 5 minutes, prolong as required. For cleaning diamond cutters, sonicate in 50 % Helizyme for 30 minutes in an ultrasonic water bath set at 60 C. After cleaning, rinse instruments thoroughly with water and proceed as required. The solution should be renewed daily, or if visibly soiled. Follow instructions of the manufacturer of instruments and endoscopes. Especially channels of flexible endoscopes must be cleaned with brushes and flushed with water, e.g. by using a syringe. Unit of sale 1000 ml bottle, 5 litre canistre Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): ca. 6 ca. 7 Density (20 C, g/cm 3 ): ca Appearance Clear, blueish clear, light blue Perfume-free Helizyme Composition: Surfactants, enzymes, complexing agents, corrosion inhibitors, excipients. Ingredients in accordance with the Regulations for Detergents EG 648/2004 < 5 % anionc surfactants, < 5 % non-ionic surfactants, < 5 % polycarboxylate, methylparabene, enzymes Labelling in accordance with the Dangerous Substances Directive Irritant. Irritating to eyes. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of in a safe way. Keep out of the reach of children. 11

12 Cleaning Cleaner N Cleaning of heat sensitive and heat resistant medical devices Cleaner N reliable cleaning power Properties Cleaner N For manual and semi-automatic cleaning of surgical instruments, rigid and flexible endoscopes Economically low ready-to-use working concentration. (1% / 15 min.) Excellent cleaning power to remove protein- or lipid based soil. ph-neutral and therefore, highly material compatible May be used in an ultrasonic bath Instructions for use 1 % (diluted with hand warm water). Soak instruments, ensure they are fully covered. Use suitable cleaning utensils. Exposure time 15 minutes, prolong as required. After cleaning, rinse instruments thoroughly with water and proceed as required. The solution should be renewed daily, or if visibly soiled. Follow instructions of the manufacturer of instruments and endoscopes. Especially channels of flexible endoscopes must be cleaned with brushes and flushed with water, e.g. by using a syringe. WGO / WEO* Global Guidelines recommend low-foaming, endoscope-compatible detergents for manual cleaning of flexible endoscopes. Unit of sale 1000 ml bottle Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): ca. 6.7 ca. 7 Density (20 C, g / cm 3 ): ca Appearance clear, colourless clear, colourless ph-neutral Cleaner N Composition: Surfactants, complexing agents, corrosion inhibitors, perfume, exipients Ingredients in accordance with the Regulations for Detergents EG 648/2004 < 5 15 % anionic surfactants, < 5-15 % nonionic surfactants, < 5 % polycarboxylates, glutaral, perfume (Limonene) Labelling in accordance with the Dangerous Substances Directive: n.a. * WGO = World Gastroenterolgoy Organization / WEO = World Endoscopy Organization, Endoscope disinfection - a resource-sensitive approach, Feb

13 Cleaning Melseptomat G Decentralized automatic dosing unit with the key to success Melseptomat G easy to operate Properties Melseptomat G Single-button operation Extreme robust stainless steel housing (1.5 mm steel sheet), vandal-proof operator s control Operating status, empty or fault messages are displayed via the green/red lights (LED) integrated in the operatorbutton Removable, autoclavable mixing container Preselection of the dosage via key selector Dosing preselection: 0.25 %, 0.5 %, 1 %, 1.5 % 2 %, 4 % Predefinalbe amount of ready-to-use working solution from 1 to 50 litres. Dosing may be stopped at any time by pressing the button. Dosing calibration without opening the device Dosing error: +6.5 % Microprocessor controlled system Sensors monitor the dosing Automatic stop if concentrate or water levels are low Instructions for use Simply press a button and the Melseptomat G delivers a ready-to-use working concentration made from a disinfectant or cleaner concentrate and tap water, accurately prepared in the predefined dilution rate. Suitable for all areas inside hospitals, food sector or pharmaceutical / medical industry, where exact dosing is required. Find more information on YouTube just search for Melseptomat Unit of sale Melseptomat G, Decentralized automatic dosing unit, Calibration set for Melseptomat G In line with latest RKI recommendations for decentralized automatic dosing systems Hygienic, autoclavable mixing container 13

14 Cleaning and Disinfection Instruments Manual processing of instruments 1 Put on gloves and PPE. 2 Fill container, e.g. instrument bath, with ca. 20 C water. 3 Using a suitable dosage system, measure disinfectant and add to the water; for a powder product, wait until the disinfectant has dissolved. 4 To mix, move tray upwards and downwards. 14

15 Cleaning and Disinfection 5 Place instruments and equipment in the solution, making sure they are fully immersed. 6 Close bath. 7 Wait until the exposure time has fully elapsed. (The exposure time starts, when the last instrument is placed in the bath). 8 Rinse the instruments thoroughly under cold running tap water. Perform the final rinse in demineralized or distilled water. Dry instruments with an absorbent, lint-free cloth towel. 15

16 Automatec reprocessing Automated reprocessing Modern washer disinfectors must conform to EN ISO standards. As opposed to manual reprocessing, automated reprocessing must be validated. If the process is near or even beyond the process safety limit, high-value surgical instruments are at risk of being damaged and patient safety is endangered by inadequately cleaned instruments. To handle such complex technologies, to preserve material properties and to optimize your automated cleaning process to safeguard patients B. Braun is a reliable partner, as B. Braun has core competence / know-how in all the following relevant segments: Instrument manufacturing, research and development Instrument reprocessing (from simple manual preparation to CSSD management) Research, development, manufacturing and application of disinfectant and cleansing products for manual and automated reprocessing Infection control consulting, process optimization and process validation Further training (specialist courses for sterilization assistants) Overview Process Alkaline Neutral / enzymatic Neutral / enzymatic ph value ph > 10 ph = 7 ph = 7 Cleaning Helimatic Cleaner alcaline Helimatic Cleaner neutral Helimatic Cleaner enzymatic Helimatic Cleaner neutral Helimatic Cleaner enzymatic Neutralising Helimatic Neutralizer C Helimatic Neutralizer forte Helimatic Neutralizer C Helimatic Neutralizer forte Disinfection Thermal Thermal Chemo-thermal Helimatic Disinfectant Final rinse Helimatic Rinse neutral Helimatic Rinse neutral Anaesthesia equipment Flexible endoscopes Rigid endoscopes Micro-surgical instruments Minimally invasive surgical instruments Surgical instruments Operating theatre shoes Laboratory glassware Beds, containers Infant feeding bottles 16

17 Automatic cleaning Helimatic Cleaner neutral Liquid ph-neutral cleaner Helimatic Cleaner neutral material friendly Properties Helimatic Cleaner neutral For automated reprocessing of heat sensitive and heat resistant medical devices, surgical instruments, flexible endoscopes, instrument containers, anaesthesia equipment and nursing trolleys. Possesses excellent cleaning capabilities, particularly against blood and protein contaminations including inaccessible places, such as found in MIS-instruments. Incorporates a foam-free mode of action at all ranges of temperature, as well as under cold water, high turbulences and protein loading conditions. Solvent free, enzyme free, non-flammable, non-irritant and therefore extremely safe to handle. Possesses a broad material compatibility including heat sensitive materials e.g.: latex, rubber, silicon, plastic, glass, metals and coloured anodized aluminium. Dosage and instructions for use For automated reprocessing in a washer and disinfector, Helimatic Cleaner neutral is used in a concentration between 0.1 and 0.5 %. An additional step of neutralisation is not necessary. The adjustment of the concentration takes place via dosage pumps (see manufacturer s instructions). A final rinse with demineralised water prevents stains on metallic surfaces. Cleaning of nursing trolleys: Helimatic Cleaner neutral can used in combination with the ph-neutral clear rinse, Helimatic Rinse neutral. Unit of sale 5 litres canister, 25 litres canister, 200 litres drum, 600 litres container, 1000 litres container Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): ca. 6 ca. 7 Density (20 C, g / cm 3 ): ca Appearance clear, liquid Ternary surfactant system, patented Helimatic Cleaner neutral Composition: Surfactants, complexing agents, corrosion inhibitors, preservatives, perfume, expients Ingredients in accordance with the Regulations for Detergents EG 648/2004 <5 % anionic surfactants, <5 % nonionic surfactants, 5 % NTA, <5 % phoshonate, <5 % polycarboxylate, glutaral, perfume Labelling in accordance with the Dangerous Substances Directive: n.a. 17

18 Automatic cleaning Helimatic Cleaner alcaline Alkaline cleaner for automated reprocessing Helimatic Cleaner alcaline in line with RKI recommendation to minimise the risk of transmitting CJD/vCJD Properties Helimatic Cleaner alcaline Helimatic Cleaner alcaline is a powerful alcaline liquid cleaner for alkaline resistant surgical instruments and stainless-steel equipment, anesthesia accessories, baby s bottles, synthetic containers, rigid endoscopes, MIS instruments, laboratory glassware and surgical shoes. Contains a special surfactant system to face the new challenges of hygienic safety Offers an optimised cleaning of proteins, lipids, body fluids and other organic compounds Can also be used in difficult instrument treatment situations Phosphate-free Silicate-free Contains corrosion inhibitors Low-foaming even in cases of high organic loading Dosage and instructions for use Helimatic Cleaner alcaline is used in a concentration between 0.3 % and 0.8 %. The use and dosage of Helimatic Cleaner alcaline must be determined by the user to suit the individual reprocessing requirements in the CSSD. The program and the dosing in an automated washer and disinfector must be adjusted carefully and controlled regarding material compatibility as well as biocompatibility before the process can be released for routine reprocessing of instruments. Helimatic Neutralizer C or Helimatic Neutralizer forte are suitable for neutralization of alkaline residues. Unit of sale 5 litres canister, 25 litres canister, 200 litres drum, 600 litres container Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): ca ca. 11 Density (20 C, g / cm 3 ): ca Appearance clear, pale yellow ph >10, surfactants Helimatic Cleaner alcaline Composition: contains 5-15 % complexing agents, < 5 % anionic surfactants, < 5 % non-ionic surfactants, < 5 % polycarboxylates, corrosion inhibitors, excipients in alkaline formulation. Ingredients in accordance with the Regulations for Detergents EG 648/2004 < 5 % anionic surfactants, < 5 % non-ionic surfactants, 5 % NTA, <5 % phosphonate < 5 % polycarboxylates Labelling in accordance with the Dangerous Substances Directive Corrosive. Causes burns. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of in a safe way. Wear suitable gloves and eye/ face protection during use. In case of accident or if you feel unwell, seek medical ad vice immediately and show the label if possible. Keep out of reach of children. 18

19 Automatic cleaning Temperatur ( C) Example for an automated cycle: Drain a b Drain c d Drain Drain Drain Drain Time (min.) i. Reusable medical devices should be reprocessed in line with the manufacturers instructions. ii. Pre-Wash Cold water without any additives a) 5 min. using cold water without any additives e f g h iii. Cleaning b) Adding Helimatic Cleaner alcaline into cold and/or warm water preferably fully demineralised water / warm up, c) 5 10 min. at C iv. First intermediate rinse d) add Helimatic Neutralizer C or Helimatic Neutralizer forte 2 min. in cold or warm water (avoid temperatures above 60 C) v. Second intermediate rinse e) using hot o r cold water, no additives (preferably fully demineralised water) vi. Thermal disinfection f) using hot or cold water (using fully demineralised water prevents spotting, stains, deposits and corrosi on on the surface of the instruments.) If drying aids are added to shorten the drying period, check material compatibility and biocompatibility of the drying aid. g) Disinfect for 5 min. at 90 C vii. Drying / cooling h) The process time depends on the machine type. 19

20 Automatic reprocessing Helimatic Neutralizer C Neutraliser for automatic reprocessing Helimatic Neutralizer C citric acid Properties Helimatic Neutralizer C Helimatic Neutralizer C is a liquid neutraliser containing phamaceutical grade citric acid It is above all used for the neutralisation of alkaline resides during automatic reprocessing of instruments Free of surfactants Good material compatibility Dosage and instructions for use Helimatic Neutralizer C is used in a concentration between 0.05 % and 0.3 %. Helimatic Neutralizer C is a liquid neutraliser containing citric acid which is used for the neutralisation of alkaline resides during machine processing of instruments. The use and dosage of Helimatic Neutralizer C must be determined by the user to suit the individual reprocessing requirements in the CSSD. The program and the dosing in an automated washer and disinfector must be adjusted carefully and controlled regarding material compatibility as well as biocompatibility before the process can be released for routine reprocessing of instruments. Even in a process using a ph-neutral cleaner, it may be advisable to add an acidic neutralizer to the first intermediate rinse in order to prevent deposits (e.g. in cases where the water used has a high salt content) Acidic neutralizer carried over into the final rinse in a washer in disinfector followed by autoclaving may cause grey to black discolouration of surgical instruments made of stainless steel. Unit of sale 5 litres canister, 25 litres canister, 200 litres drum, 600 litres container Physico-Chemical Data Concentrate ph-value (20 C): ca. 2.5 Density (20 C, g/cm 3 ): ca 1.12 Appearance clear, liquid Free of phosphates and surfactants Helimatic Neutralizer C Composition: % Citric acid Ingredients in accordance with the Regulations for Detergents EG 648/2004 n.a. Labelling in accordance with the Dangerous Substances Directive Irritant Irritating to eyes. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of in a safe way. Keep out of the reach of children. 20

21 Automatic reprocessing Helimatic Neutralizer forte Neutraliser for automatic reprocessing Helimatic Neutralizer forte phosphoric acid Properties Helimatic Neutralizer forte Helimatic Neutralizer forte is a liquid neutraliser containing phosphoric acid It is above all used for the neutralisation of alkaline resides during machine processing of instruments Free of surfactants Good material compatibility Dosage and instructions for use Helimatic Neutralizer forte is used in a concentration between 0.1 % and 0.2 %. Helimatic Neutralizer forte is a liquid neutraliser containing phosphoric acid which is used for the neutralisation of alkaline resides during machine processing of instruments. The use and dosage of Helimatic Neutralizer forte must be determined by the user to suit the individual reprocessing requirements in the CSSD. The program and the dosing in an automated washer and disinfector must be adjusted carefully and controlled regarding material compatibility as well as biocompatibility before the process can be released for routine reprocessing of instruments. Even in a process using a ph-neutral cleaner, it may be advisable to add an acidic neutralizer to the first intermediate rinse in order to prevent deposits (e.g. in cases where the water used has a high salt content) Acidic neutralizer carried over into the final rinse in a washer in disinfector followed by autoclaving may cause grey to black discolouration of surgical instruments made of stainless steel. Overdosing of phosphoric acid may cause corrosion. Unit of sale 5 litres canister, 25 litres canister, 200 litres drum, 600 litres container Physico-Chemical Data Concentrate ph-value (20 C): ca. 2.1 Density (20 C, g/cm 3 ): ca. 1.0 Appearance clear, liquid Free of surfactants Helimatic Neutralizer forte Composition: > 30 % phosphoric acid, excipients ngredients in accordance with the Regulations for Detergents EG 648/2004 n.a. Labelling in accordance with the Dangerous Substances Directive Corrosive. Causes burns. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of in a safe way. Wear suitable protective clothing, gloves and eye/face protection. In case of accident or if you feel unwell, seek medical advice immediately and show the label if possible. Keep out of reach of children. 21

22 Drying aid for automatic reprocessing Helimatic Rinse neutral Liquid ph-neutral drying aid Helimatic Rinse neutral fast and stain free drying Properties Helimatic Rinse neutral For automated reprocessing of surgical instruments, bed frames, nursing trollies and containers. It is used for the final rinse and ensures a stain free drying of metallic and sealed surfaces. Contributes to a stain free rinse and an optimal drying result. Due to its foam-free characteristic, it is suitable in sectors with high turbulences. Non-corrosive and ph-neutral. Possesses a broad material compatibility including heat sensitive materials e.g.: latex, rubber, silicon, plastic, glass, metals and coloured anodized aluminium. Dosage and instructions for use For automated reprocessing in a washer and disinfector Helimatic Rinse neutral is used in the final rinse at a concentration of %. The adjustment of the concentration takes place via dosage pumps (see manufacturer s instructions) In urgent cases, where a quick availability of the treated instruments or the equipment is necessary, a process temperature of at least 80 C is recommended. Unit of sale 5 litres canister, 25 litres canister, 200 litres drum Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): ca. 7 ca. 7 Density (20 C, g / cm 3 ): ca Appearance clear, liquid Low cytotoxicity Helimatic Rinse neutral Composition: non-ionic surfactants, alcohols, excipients. Ingredients in accordance with the Regulations for Detergents EG 648/2004 <5 % nonionic surfactants Labelling in accordance with the Dangerous Substances Directive Irritant, Flammable. Risk of severe eye damage. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of in a safe way. Wear face / eye protection. Keep out of reach of children. 22

23 Automatic cleaning Helimatic Latriniser Acid cleaner and rinse aid for automatic bed-pan washers Helimatic Latriniser shiny and clean bedpans Properties Helimatic Latriniser For automatic bed pan washer disinfectors with thermal disinfection of bed pans, urinals. Stain free drying with shiny surfaces. Prevents limescale in steam generators, pipework and nozzles even with very hard water. For optimised, spot-free drying. Suitable for acid-resistant bedpan washer disinfectors. High level material tolerance towards special steel, aluminium, plastics and glass. Dosage and instructions for use Helimatic Latriniser is used at a concentration of 3 5 ml / l with a water hardness of < 15 dh (< 27 f) 5 10 ml / l with a water hardness of > 15 dh (> 27 f) Special combination based on organic acids and surfactants. Unit of sale 5 litres canister, 25 litres canister, 200 litres drum, 600 litres container * Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): ca. 1.8 ca. 3 5 Density (20 C, g / cm 3 ): ca ca Appearance clear, liquid Effective and economic Helimatic Latriniser Composition: nonionic surfactants, organic acids, solubilizer, preservatives, excipients Ingredients in accordance with the Regulations for Detergents EG 648/ % nonionic surfactants, preservatives, phenoxyethanol Labelling in accordance with the Dangerous Substances Directive Irritant Risk of serious damage to eyes. Avoid contact with skin. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of in a safe way. Wear eye/face protection. Keep out of the reach of children. 23

24 Automatic cleaning Helimatic Cleaner enzymatic Enzymatic cleaner for gentle automatic reprocessing of flexible endoscopes and medical devices Helimatic Cleaner enzymatic gentle and efficient cleaning Properties Helimatic Cleaner enzymatic For automated cleaning of flexible endoscopes and heat sensitive medical devices For automatic reprocessing of instruments and anaesthesia equipment. Effective and economic Easily removes dried on blood and secretions Excellent material compatibility Uses a particularly efficient and innovative combination of ingredients to optimise cleaning performance Has an outstanding cleaning performance, particularly where blood and protein contaminants are concerned, including inaccessible areas. Incorporates a foam free mode of action at all ranges of temperature, as well as under cold water, high turbulences and protein loading conditions. Has a high level of material compatibility especially with plastics and metallic surfaces. Dosage and instructions for use The cleaning step plays a key role in thermo chemical processing. The success of the processing depends on thorough cleaning in order that the flexible endoscope is free of secretion- and protein-residuals. This prevents the incrustation of any remaining contamination during the subsequent disinfecting stage and drying phase. Helimatic Cleaner enzymatic was developed to meet these requirements. This high-performance product has a neutral ph value and ensures that the best possible cleaning result is achieved, and yet it is particularly suited to the preparation of delicate instruments. Helimatic Cleaner enzymatic demonstrates excellent cleaning power which is normally achieved by alkaline formulations only. Unit of sale 5 litres canister, 25 litres canister, 200 litres drum, 600 litres container Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): 6 ph-neutral Density (20 C, g/cm 3 ): ca 1.07 ca. 1.0 Appearance clear, liquid Innovative combination of enzymes and surfactants Helimatic Cleaner enzymatic Composition: < 5 % anionic sur factants, < 5 % non-ionic surfactants, enzymes, salts of organic acids, solvents, dispersion agent, corrosion inhibitors, preservatives, excipients. Ingredients in accordance with the Regulations for Detergents EG 648/2004 < 5 % anionic surfactants, < 5 % non-ionic surfactants, < 5 % polycarboxylate, methylparabene, enzymes Labelling in accordance with the Dangerous Substances Directive Keep out of reach of children. 24

25 Automatic chemo-thermal disinfection Helimatic Disinfectant Liquid disinfectant for gentle automatic reprocessing of flexible endoscopes and medical devices Helimatic Disinfectant for chemo thermal reprocessing Properties Helimatic Disinfectant For automated disinfection of flexible endoscopes and heat sensitive medical devices Broad efficacy spectrum Effective and economic Has a high level of material compatibility especially with plastics and metallic surfaces. Microbiological Effi cacy Microbiocidal performanced of Helimatic Disinfectant (in vitro) Test organism/virus Conc. Application Tim Temp. S. areus 0.25 % 5 min. 45 C P. aeruginosa 1.0 % 5 min. 35 C M. terrae 1.0 % 5 min. 45 C E. hirae 1.0 % 5 min. 45 C C. albicans 0.5 % 5 min. 45 C Polio 1.0 % 5 min. 50 C Adeno 1.0 % 5 min. 45 C Expert reports are available on demand Dosage and instructions for use The cleaning step plays a key role in thermo chemical processing. The success of the processing depends on thorough cleaning in order that the flexible endoscope is free of secretion- and protein-residuals. This prevents the incrustation of any remaining contamination during the subsequent disinfecting stage and drying phase. Reprocessing (cleaning and disinfection) of flexible endoscopes Wear gloves and personal protective equipment, follow the reprocessing recommendations of the endoscope manufacturer Pre cleaning in the examination room: immediately after the examination (Helizyme, enzymatic cleaner) Manual cleaning in the reprocessing room: clean the channels and other parts of the endoscope with special cleaning brushes (Helizyme, enzymatic cleaner). Rinsing: Rinse with water Machine reprocessing in a washer-disinfector for flexible endoscopes. Allow to dry completely. (Low temperature sterilization: if available and required) Store in a cabinet recommended by the endoscope manufacturer. Unit of sale 5 litres canister, 25 litres canister Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): 6 ph-neutral Density (20 C, g / cm 3 ): ca 1.07 ca. 1.0 Appearance clear, liquid Highly effctive H e l i m a t i c Disinfectant Composition: 100 g solution contains 20 g glutaral, solvents, salts of organic acids, corrosion inhibitors, excipients. Ingredients in accordance with the Regulations for Detergents EG 648/2004 < 5 % phosphonate Labelling in accordance with the Dangerous Substances Directive Corrosive. Harmful by inhalation and if swallowed. Causes burns. May cause sensitization by inhalation and skin contact. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of in a safe way. Wear suitable protective clothing, gloves and eye/face protection. In case of accident or if you feel unwell, seek medical advice immediately (show the label if possible). Keep out of reach of children. 25

26 Automatic reprocessing Heli-Dos Refilling system for the continuous supply of media to automatic washer-disinfectors Heli-Dos tested and delivered ready for connections and ready to mount Properties Heli-Dos Automatic refilling of upstream containers to deliver continuously process media from 600 litres bulk containers or 200 litres drums to automated washer disinfectors. Waste, time and cost saving compared to the use of conventional 5 or 10 litres canisters. Easy to operate essential for routine tasks! Economical High level of reliability Suitable for Helimatic reprocessing agents Not suitable for processing agents: that are highly flammable based on peracetic acid or hydrogen peroxide Dosage and instructions for use Automatic operation. One-man operation; all the sensor and actuator states can be read off both the upstream container and the output unit. Delivers until the pump draws in air. No need for the time consuming task of emptying residual amounts from incompletely emptied drums. Delivery and assembly As per offer. Unit of sale Heli-Dos refilling system Output unit, incl. power supply unit. Upstream container. Media line, flexible (PE) in protected hose incl. clamping. Electrical control line, three-core. Heli-Dos Safety requirements: IEC (2001) (2nd edition); EN (2001) (2nd edition) EMC: EN 61326: A1: A2: A3:2003 EU-Directives: 2006/95/EC /108/EC /95/EC /96/EC 26

27 Dentistry Tiutol dent For manual processing of dental equipment (for disinfectant cleaning of aspirator equipment) Tiutol dent for dentistry Properties Tiutol dent Disinfectant concentrate for manual processing of dental equipment (for disinfectant cleaning of aspirator equipment) Appropriate for dental aspirators and amalgam collectors Active against bacteria, mycobacteria (M. terrae), fungi, enveloped and non-enveloped viruses (incl. HBV / HCV / HIV) Very high cleaning performance Optimised formula, no smell of chlorine Good material compatibility Dosage and instructions for use Tiutol dent is used at 3 % 60 min. Tiutol dent is an effective product that combines strong cleaning power with the appropriate disinfectant properties for this particular application. It should be used twice daily (at midday and in the evening) for systems with and without amalgam collectors. This is an important step towards comprehensive hygienic safety in dental practice. Tiutol dent has successfully been used in practice for more than 10 years. Its exceptional cleaning performance helps to reduce maintenance and repair costs. Cleaning and disinfecting in just one step 1. Wear gloves 2. Fill the rinsing beaker with 970 ml cold water and add 30 ml Tiutol dent. 4. Place the aspirator in the freshly prepared solution. 5. Siphon the ready-to-use solution through, except for about 300 ml. Remove the aspirator and allow to take effect for 30 minutes. 6. Use the remaining solution to clean and disinfect the rinsing bowl (with a brush if necessary). Caution: Do not mix with aicds, other disinfectants or cleaners. This could result in the release of toxic chlorine gas! Unit of sale 5 litres canister Physico-Chemical Data Concentrate Ready-to-use solution ph-value (20 C): ca Density (20 C, g / cm 3 ): ca 1.24 Appearance clear, pale yellow excellent cleaning power Tiutol dent Composition: 100 g solution contains sodium hypochlorite (3.9 g available chlorine), sodium hydroxide, stabilizer, corrosion inhibitors, water Ingredients in accordance with the Regulations for Detergents EG 648/2004 < 5 % Polycarboxylates Labelling in accordance with the Dangerous Substances Directive Corrosive. Wear suitable protective clothing, gloves and eye/face protection. Causes severe burns. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). Do not mix with Acids. Contact with acids liberates toxic gas. Keep out of the reach of children. 27

28 B. Braun Disinfectants - Overview Part 1 Product Hand Disinfection Hand / Skin Cleaning Hand / Skin Care Personal Hygiene Nasal Gel Therapeutic Indications Oral cleansing Coloured Free of colourants Free of perfume For Sensitive Skin For Normal Skin Skin Disinfectant Softa-Man ViscoRub / Softalind ViscoRub Softa-Man acute / Softalind 999 Softa-Man / Softalind Handsanitizer Softa-Man pure / Softalind pure Promanum N Promanum pure Lifo-Scrub Lifosan soft Lifosan pure Softaskin Softaskin pure Softaderm pearl Trixo Trixo -lind Trixo -lind pure Softasept N Braunoderm Braunol Chlorhexidine 2% alcoholic solution Prontosan Wound Spray Prontosan Wound Irrigation Solution Prontosan Wound Gel / Wound Gel X Braunovidon Ointment / Ointment Gauze Alcohol Pads B. Braun Softa Swabs Prontoderm Solution Prontoderm Wipes Prontoderm Nasal Gel Prontoderm Shower Gel Prontoderm Foam ProntOral Prontosan C 1) According to RKI recommendations, Federal Health Gazette ) DGHM: German Society for Hygiene and Microbiology 3) VAH: Association for Applied Hygiene 28

29 Efficacy Disinfecting Agent Application Antiseptic of Mucous Membranes Wound Treatment / Therapy Bacteria Tuberculosis Bacteria MRSA Spores Fungi Enveloped Viruses (incl. HBV, HCV, HIV) 1) Fully Virucidal 1) Noroviruses (FCV / MNV) Alcohol Polihexanide Chlorhexidine Povidone-Iodine Ready-to-Use ~ ph of Ready-to-Use Solution Concentrate for Dilution Concentration for Use (DGHM 2 / VAH 3 ) / EN 1500 Application Time (DGHM 2 / VAH 3 ) / EN 1500 Outbreak Management n.a. Conc. 15 sec. n.a. Conc. 15 sec. 30 sec. n.a. Conc. 15 sec. n.a. Conc. 15 sec. n.a. Conc. 15 sec. n.a. Conc. 15 sec. 60 sec n.a. Conc. 15 sec. n.a. Conc. 15 sec. 5.7 Conc. 15 sec. n.a. Conc. 15 sec min. n.a. n.a. 6 2 min. 6 2 min min. 6 2 min. 6 1 min. 6 1 min. 29

30 Therapeutic Indications Spectrum B. Braun Disinfectants - Overview Part 2 Product Surface Disinfection (Biocide) Surface Cleaning Surface Disinfection of non-invasive Medical Devices Large Surfaces / Areas Small Surfaces / fast acting Sanitation of Dental Suction Systems and Amalgam Separators Instrument Disinfection Instrument Cleaning Disinfection of Hemodialysis Equipment Bedpan Machine Cleansing For Metal, Glass, Ceramic For Thermolabile Instruments For Flexible Endoscopes Bacteria Tuberculosis Bacteria MRSA Meliseptol Foam pure Meliseptol rapid Meliseptol Meliseptol Wipes sensitive Meliseptol HBV Tissues Softa Cloth CHX 2 % Hexaquart forte Hexaquart plus / lemon fresh Melsept SF Melsitt Hexaquart S Helipur Helipur H plus N Stabimed Helizyme Cleaner N Helimatic Cleaner neutral Helimatic Rinse neutral Helimatic Cleaner alcaline Helimatic Neutralizer C Helimatic Neutralizer forte Helimatic Cleaner enzymatic Helimatic Disinfectant Helimatic Latriniser Citric Acid Solution 50 % Tiutol KF Tiutol dent 1) According to RKI recommendations, Federal Health Gazette ) DGHM: German Society for Hygiene and Microbiology 3) VAH: Association for Applied Hygiene 30

31 Disinfecting Agent Application Spores Yeasts (levurocidal) Fungi Enveloped Viruses (incl. HBV, HCV, HIV) 1) Fully Virucidal ) Noroviruses (FCV / MNV) Alcohol Polihexanide Aldehyde Formaldehyde-free Phenol Derivative Quarternary Ammonium Compounds Alkylamine Povidone-Iodine Citric Acid Active Chloride Ready-to-Use ph of Ready-to-Use Solution Concentrate for Dilution Concentration for Use (DGHM 2 / VAH 3 ) Contact Time (DGHM 2 / VAH 3 ) Outbreak Management 7.0 Conc. 1 min. 7.0 Conc. 1 min. 7.0 Conc. 5 min. 7.0 Conc. 1 min. 7.0 Conc. 1 min. 6.5 Conc. 15 sec % 2.0 % 5 1 min. hr. 0.5 % 0.25 % 0.5 % 2.0 % 0.5 % 2.0 % 1 hr. 4 hrs. 1 hr. 15 min. 1 hr. 15 min. 10 % 4 hrs % 1 hr % 3.0 % 1.0 % 1.5 % 0.5 % 2.0 % 1 hr. 6 % 5 min. 2 6 hrs. 30 min. 15 min. 1 hr. 15 min % 5 min % 15 min % % % 0,05 0,3 % % % % 5 Min. 55 C % % % 60 min % max. 60 C 1 Min. 83 C 15 Min. 60 C 31

32 B. Braun Medical AG Infection Control Seesatz 17 CH-6204 Sempach Tel Fax IC1686_