EUROWASHER. Washing-thermo disinfector. Medical device

Transcription

1 EUROWASHER Washing-thermo disinfector Medical device

2 EUROPEAN INFECTION CONTROL Series 10, 15 and 18 with vertical sliding doors Series VSD Series VSD Series VSD Compact dimensions, versatility and rapidity. Series 16 and 32 with horizontal sliding doors Series VSD Series VSD Ergonomic load, rapidity and high productivity 2

3 Technology The Eurowasher range is a series of new generation washing thermo-disinfectors, result of the most advanced design by Schlumbohm & Angelantoni Life Science, Leader in the world of Infection Control. German technology combined with Italian design and creativity, together with the Corporate Know-how matured over decades of activity in the sector, have supported the development of equipment based on the concept of total quality, able to meet the requirements of an Elite market requiring total safety assurance, absolute reliability and sterilization processes that can be repeated in time, without burdening operators with the risk of assessment. Total quality to produce medical devices with high construction standards, advanced techniques and innovative solutions. Total quality for an environmentally-friendly project with almost zero impact on the environment by water consumption, and extremely low for electricity and heat dissipation. +50% Service life Sinergy Exerience Know-how Ability Customer support Saving The constant research for greater productivity and efficiency distinguishes and accompanies us on a design journey aimed at Safety, Total quality and Savings. Saving is one of the aims that we set ourselves in the design phase: saving in operating consumption, saving of maintenance with devices, solutions and components of high quality and reliability and long service life. Use In a medical device manufacturing process, the instrument washing and disinfecting appliance plays a critical role, being a fundamental step to first bring down and then stabilise the microbial load and assure repeatable reduction over time. The appliances of the Eurowasher instrument wash and disinfect range have been designed to be installed in the sterilization stations and are second only to the sterilizer for the intended use, which is to produce surgical instruments washed perfectly and with a significant SAL. 3

4 EUROPEAN INFECTION CONTROL Washing and disinfection cycles The Eurowasher line is configured with the following cycles: 1 2 -Thermo-chemical washing and disinfection for surgical instruments at 93 C - Thermo-chemical washing and disinfection for containers at 93 C Automatic washing The automatic wash reduces contamination risks to be reduced, accelerates washing times, reduces costs and means the washing cycle can be validated. In order to ensure that the process remains constant over time, the equipment in the Eurowasher range is fitted with devices and sensors to verify and confirm data and prevent any kind of error Thermo-chemical washing and disinfection for surgical microinstruments at 93 C - Thermo-chemical washing and disinfection for basins at 93 C for - Thermo-chemical washing and disinfection for anaesthesia material at 65 C - Thermo-chemical washing and disinfection for glass-ware and baby bottles at 93 C - Thermo-chemical washing and disinfection for medical shoes at 65 C - Equipment washing and self-disinfection In fact, after experimental tests, constant monitoring of parameters is carried out. These parameters can affect the result and/or make it inconsistent over time, such as: water pressure water temperature water jet moving speed water jet mechanical action chemical product added The appliances in the Eurowasher range have been tested in compliance with the standard of reference as well as similar ones to assess washing quality. 4

5 Disinfection As well as perfect cleaning of the instruments, it is essential to achieve a substantial reduction of the microbial load at the end of the washing and disinfection process. Furthermore, a constant value should be obtained at the end of the process with a final SAL of 10 2 in order to be able to ensure an SAL of 10-6 after sterilization. Constant and precise monitoring of the bioburden allows the validity of disinfection, and the trend over time, to be assessed. The thermochemical energy released by the chemical solution, diluted in hot water, allows to obtain a double effect by attacking the micro-organisms with two different activities overcoming their resistance. Any equipment in the Eurowasher range is fitted with devices and sensors to verify and confirm data and to prevent any kind of error, in order to ensure the process as well as the final constant results. After experimental tests, constant monitoring is carried out to check parameters that affect the result and/or make it constant over time, such as: detergent and disinfectant dosage checking PH on discharge water temperature contact time of water with the surface of the instruments (A0) chemical residue after rinsing The appliances in the Eurowasher range have been tested in compliance with the standard reference as well as similar ones to assess disinfection quality. Bioseal The modern concept of a sterilization unit calls for equipment, flows, paths, procedures, checks and traceability that must be implemented in order to consider instruments reprocessing safe. Specifically, the separation of clean and dirty environments is thus essential to reduce contamination risks. Hence the need to create a barrier inside the instrument wash and disinfect appliance, between clean and dirty, that prevents contact between the areas. The Eurowasher line is produced in order to fully meet this need through complete separation of the equipment on the sterile side - the so-called Bioseal, which is aligned and sealed with the wall. 5

6 EUROPEAN INFECTION CONTROL Quick cycles The Eurowasher line has a series of features that make the washing and disinfection cycle faster, compared with the classic instrument washer. The care in the details of the plants, components and devices is affecting the washing and disinfection cycle performance, speeding up phases, reducing time and increasing the production capacity. In particular: the reduced amount of water per phase the shape of the chamber to take water back to the pump quickly water preheating quick water loading -25% Cycle time the high performance recirculation pump the quick water discharge and turbulent flow drying through the impeller blades of the trolley the diffusers in the lower part of the chamber opposite the suction Ergonomic loading The Eurowasher range features an ergonomic loading height enhanced by the door(s) horizontal sliding. This makes it possible to easily reach all loading planes as well as making the arrangement of instruments, baskets, containers, glassware, micro surgical instruments and clogs safer, reducing the risks of incidents due to operators visibility. Environmental impact The Eurowasher line has been developed by applying environmentally friendly design with the aim of preserving the planet environment. AIC adopted innovative technical solutions and high quality components, in order to significantly reduce consumption and, therefore, reduce pollution throughout the entire cycle. Highlighted aspects are: water consumption energy consumption recycling -20% Water consumption Washing-disinfection chamber is designed to allow the circulation pump to work properly with a lower consumption of water. 20 % water Saving for each type of connection -40% Energy consumption 100% Recyclable 6

7 Industrialisation The position of the components, main units and operational phases to facilitate pre-assemblies and general assemblies, are analysed since the design phase, to significantly reduce times and costs in a serial production. The reduction of phases and the repetition of assembly operations, together with the optimisation of the semi-finished products, support the industrialisation of the production process and constant preservation of high quality standards of the product. Validation Validation is one of the most important operations as it allows verifying, after installation, whether design conditions are respected. In particular, for the load object of the validation, we can verify that temperature, doses of chemical solutions and time fall within the correct parameters to ensure the effectiveness of the washing and disinfection process in compliance with the reference standard UNI EN ISO Directives, Certificates, Quality and Construction Standards The Eurowasher line equipment is CE marked with the identification number issued by the Notified Body according to European Directive 93/42/EEC and 2007/47/EEC as a Medical Device and with European Directive 2009/125/EEC (eco-design). They also comply with European Directives: 2006/95/EEC for Low Voltage, 2004/108/EEC for Electromagnetic compatibility and 2006/42/EEC for Machinery. Construction is done in compliance with the European Standards of reference UNI EN ISO :2009 (washing and disinfection) and those related to it. UNI EN ISO (development, validation and routine testing), CEI EN ISO (electrical safety), CEI EN ISO (electrical safety), CEI EN ISO (electrical safety) CEI EN ISO (electrical equipment), UNI CEI EN ISO :2005 (conformity assessment), UNI EN ISO :2000 (risk analysis), EN IEC 62304:2006 (software validation) and EN IEC 62366:2008 (human-machine interface).all of that within a UNI EN ISO 9001 Quality System (quality certification) and UNI EN ISO (medical quality certification). 7

8 EUROPEAN INFECTION CONTROL Accessories External trolley Adjustable external trolley Automatic loading system Automatic unloading system Range of EUROWASHER products VSD series vertical sliding doors Series Model Capacity (lt) Trays 1 DIN Chamber dimensions (WxHxD mm) Overall dimensions (WxHxD mm) 10 MD.WSD /2VSD.E/SE/E-SE x670x X2000X MD.WSD /2VSD.E/SE/E-SE X670X X2000X MD.WSD /2VSD.E/SE/E-SE X795X X2000X1100 HSD series horizontal sliding doors Series Model Capacity (lt) Trays 1 DIN Chamber dimensions (WxHxD mm) Overall dimensions (WxHxD mm) 16 MD.WSD /2HSD.E/SE/E-SE X1050X X2000X MDWSD /2HSD.E/SE/E-SE X1050X X2000X1525 Definition of the model code: Eurowasher: Surgical instrument washing and disinfecting device Medical Device - MD : Hospital Application Termochemical - WSD : Washing and Disinfection Medium Series - 10/15/16/18/32 : DIN tray loading capacity (dimensions 480X240x50 mm) Volume liters - from 328 to 1010 lt : Chamber capacity in litres Execution - 1 o 2 : Numbers of doors Door movement - HSD : Automatic horizontal sliding door Example model MDWSD VSD.E Medical Device Termochemical 10 DIN 300 litri 2 Automatic vertical sliding doors Electrical internal steam generator Example model MDWSD HSD.S Medical Device Termochemical 16 DIN 500 litri 1 Automatic vertical sliding door Connection to central steam Door movement - VSD : Automatic vertical sliding door Heating: E: Internal Electrical Steam Generator S: Centralized steam ES: Electrical-steam SE: Steam Exchanger 8

9 Main construction features AISI 304 stainless steel frame, front and side panels. AISI 316L, 2 mm thickness washing chamber. Chamber bottom with central drain and filtration. Door/s in double high resistance thermal glass with argon/krypton gas. Horizontal or vertical sliding door/s. Door/s sealing by dynamic «air chamber» gasket. Drying unit complete with bacteriological filter, Turbo fan and electric heaters. Rotating washing arms on each trolley. Chamber perfectly drainable and cleanable. High-performance re-circulation pump. AISI 304 stainless steel Idraulic pipeline. Ergonomic loading height (HSD models). Double data detection systems Siemens Simatic ET200S integrated safety, programmable electronic controller. Touch screen Siemens TP700 or TP900 Comfort, 7 or 9 inches, full color and high resolution. Second touch screen on unloading side. (optional) Bio-seal shield: separation between dirty side and clean side. (optional) Built-in alphanumeric printer. Different types of internal trolleys available. Automatic connection among internal trolley and the device. Stainless steel steam condenser. (optional) Stainless steel AISI 304 containment tank for cold water. (optional) Stainless steel AISI 304 pre-heating tank for treated water. (optional) Stainless steel AISI 304 recovery tank for rinsing water. (optional) Remote connection-ready. (optional) USB connection for data back-up. Water drain pump. (optional) Monitoring and control system of the rotation of the spray arms. (optional) Central chemical dosing device. (optional) Chemicals dispenser with flow meter. (4th chemical dispenser optional) Water flow meter device. (optional) Traceability system connection. Total integrated electrical board with IP protection and telescopic arm

10 EUROPEAN INFECTION CONTROL 5-LEVEL WASHING TROLLEY 3-LEVEL WASHING TROLLEY ANESTHESIA TROLLEY LAPAROSCOPY TROLLEY MICRO-SURGERY TROLLEY GLASSWARE TROLLEY BASINS TROLLEY MEDICAL SHOES TROLLEY CONTAINER TROLLEY 10 BABY BOTTLES TROLLEY DA VINCI TROLLEY Internal trolley for surgical instruments Da Vinci is designed for washing and disinfecting surgical instruments used by the Da Vinci Surgical System Robot

11 Load capacity VSD series - vertical sliding doors SERIES 10 SERIES 15 SERIES 18 TRAYS 10 trays (x 1DIN) 15 trays (x 1DIN) 18 trays (x 1DIN) HIGH TRAYS 6 trays (h max 110 mm) 9 trays (h max 110 mm) 12 trays (h max 110 mm) ANESTHESIA 6 tubes ( max 1.5 m) 6 breathing bags or 24 breathing masks. 10 inhaler nozzles 6 tubes ( max 1.5 m) 6 breathing bags or 30 breathing masks. 10 inhaler nozzles 8 tubes ( max 1.5 m) 10 breathing bags or 40 breathing masks. 18 inhaler nozzles MICRO SURGERY 4 micro-surgey kits 4 micro-surgey kits 5 micro-surgey kits SHOES 10 pairs of medical shoes 16 pairs of medical shoes 24 pairs of medical shoes GLASSWARE 18 pieces (h max 300 mm) 36 pieces (h max 160 mm) free space (h max 50 mm) 22 pieces (h max 300 mm) 44 pieces (h max 160 mm) free space (h max 50 mm) 35 pieces (h max 300 mm) 60 pieces (h max 160 mm) free space (h max 50 mm) BASINS basins of different sizes and capacity on three levels basins of different sizes and capacity on three levels basins of different sizes and capacity on three levels CONTAINER 2 container with covers (1US) 3 container with covers (1US) 6 container with covers (1US) LAPAROSCOPY 40 laparoscopic tools 2 free tray (1DIN) 60 laparoscopic tools 4 free tray (1DIN) 78 laparoscopic tools 3 free tray (1DIN) BABY BOTTLES baby bottles - different sizes caps and nipples baby bottles - different sizes caps and nipples baby bottles - different sizes caps and nipples Load capacity HSD series - horizontal sliding doors SERIES 16 SERIES 32 TRAYS 16 trays (x 1DIN) 32 trays (x 1DIN) HIGH TRAYS 10 trays (h max 110 mm) 20 trays (h max 110 mm) ANESTHESIA MICRO SURGERY 12 tubes ( max 1.5 m) 8 breathing bags or 36 breathing masks. 14 inhaler nozzles 6 micro-surgey kits 24 tubes ( max 1.5 m) 16 breathing bags or 72 breathing masks. 28 inhaler nozzles 12 micro-surgey kits SHOES 18 pairs of medical shoes 36 pairs of medical shoes GLASSWARE BASINS 36 pieces (h max 300 mm) 36 pieces (h max 160 mm) free space (h max 50 mm) basins of different sizes and capacity on four levels 72 pieces (h max 300 mm) 72 pieces (h max 160 mm) free space (h max 50 mm) basins of different sizes and capacity on four levels CONTAINER 4 container with covers (1US) 8 container with covers (1US) LAPAROSCOPY BABY BOTTLES 80 laparoscopic tools 2 free tray (1DIN) baby bottles - different sizes caps and nipples 160 laparoscopic tools 2 free tray (1DIN) baby bottles - different sizes caps and nipples 11

12 Our skills and basic services for total customer satisfaction: Training, either at our premises a the customer s premises Testing and quality control Process Validations (IQ-OQ-PQ) Design for Central of sterilization (CSSD) and central of disinfection (CSDD). Management of traceability and remote control of the equipment Angelantoni Life Science ALS is one of the worldwide leading manufacturers of biomedical refrigeration, non contamination and sterilization equipment constantly committed to innovation and to environmental or biological safety. Research centres, hospitals, universities, chemical and pharmaceutical companies are ALS Customers: our company can satisfy any requirement of scientific refrigeration, infection Control (autoclaves) and microbiological safety through a wide range of standard and special products. In this field we can offer now a complete range of equipment and services to meet the needs of sterilization (CSSD), disinfection stations (CSDD) and special applications BSL3 laboratories - BSL4 and treating infected wastes (Biohazard). ALS can be an ideal partner in Science and Technology due to a wide range of products and to the market presence in more than 50 Countries with local Agents and Distributors. ALS invests more than 5% of its turnover in research and development involving a multidisciplinary team of scientists that support clients with cutting-edge, standard and customized solutions in terms of quality, reliability and innovation. ALS is a subholding of Angelantoni Industrie Group established in 1932, worldwide known for innovation, R&D and high tech (19 active patents) such as climatic chambers and space simulators (Angelantoni Test Technologies), spattering machines for thin film technology (Kenosistec), solar receiver tubes for concentrated solar power plants ( Archimede Solar Energy) refrigeration turbo devices for energy saving (Turboalgor) in addition to ALS advanced and patented products such as Hemosafe, Smartfreezers and Waster. Certificate tools SIT Calibration Service contracts full risk Extended warranties Research and development Production and Assembly Installation and commissioning Preventive maintenance ALS Headquarter Angelantoni Life Science srl Loc. Cimacolle 464, Massa Martana (PG) - Italy T F info@angelantoni.it - Market analysis and advice Special applications ALS Milan Branch Angelantoni Life Science srl viale Monza, Milano (MI) T. (+39) F. (+39) info@angelantoni.it - ALS products are distributed in North-Central Europe by Schlumbohm Medizin-Labor-Technologie GmbH Grenzkehre Hamburg - Germany T F info@schlumbohm-medizintechnik.de Copyright Life Science 2016 Angelantoni s.r.l./rev. 14/2016-illustrations, descriptions and technical data may change without notice.