AS 66 – Proven Hospital Sterilizers The AS 66 Series Steam Sterilizers manufactured by SMS have been designed in conformance with valid Polish and European standards, to be operated with standard charge units with the size of 300x300x600 mm. Such standards are also complied with packaging systems (baskets, trays, cans) and conveyance systems (charge and transport carts). • • • • • • • • • • • • • • • • • • • • • • • • • Te c h n i c a l f e a t u r e s : Double–ended sterilizer – loading and unloading doors are located on opposite sides of the sterilizing chamber, or single–ended sterilizer – loading–unloading door is located on one side of the chamber Steam supplied either from an external source, or from own (integral) steam generator Sterilizing chamber with heating jacket and doors made of stainless steel Outer walls (housing) made of stainless steel Support structure (main and side frame) made of stainless steel Deaeration stage consisting of fractioned vacuum phase Selectable drying methods: vacuum, vacuum–ventilation and vacuum–steam drying Automatic microprocessor control Control of particular sterilizing cycle stages Simplicity of programs operation by multifunction keyboard Possibility to set up user’s own programs Operation codes for non–standard programs Password–protected access to menu RS 485 port for connection of an external PC system LCD graphic, colour display, equipped with touch–screen – to display complete information on process parameters and its progress. Additionally it can be used as an accessory keypad Sterilizing cycle parameters recording unit, independent from control system Built–in printer for printing out sterilizing cycle protocols (identification of a sterilizer, selected program parameters, sterilizing chamber pressure and temperature, date and time etc.) Digital indication of sterilizing chamber temperature Digital indication of steam pressure in the chamber and jacket Independent temperature sensor for controlling sterilizing cycle Absolute pressure transmitter – to provide reading unaffected by atmospheric pressure Systems to reduce water consumption and to lower drain water temperature Easy to install Easy to operate, comfort in use Easy access to all components for maintenance from the side and through pivoting front covers The AS 66 Sterilizers can be tailor made to individual requirements. Unique construction solutions are SMS area of expertise. Any Client involved in purchase of a single sterilizer or furnishing the entire sterilizing plant can rely on the expertise and advice of our personnel. All equipment ordered in our company is tailor–made to suit individual technical requirements and architectonic features; it is easy to operate, providing an easy access for maintenance. Uniform Heating of Sterilizer Chamber The sterilizing chamber, together with the heating jacket and door, is made of chromium–nickel–molybdenum stainless steel. All inner surfaces have undergone special finishing treatment – by grinding and polishing. The sterilizing chamber is equipped with the heating jacket that ensures uniform heating of chamber walls to reach the sterilizing temperature. Properly shaped deflectors, fitted in steam inlets to the chamber, allow uniform and quick spreading of steam in the chamber, and prevent local overheating. Our many years experience and temperature distribution research made it possible for us to construct a chamber, in which temperature variations at any point do not exceed 1°C. The chamber with heating jacket are insulated with a layer of mineral wool, to reduce loos of heat and to ensure safe operation. Versatility of the sterilizer ensures separation of the sterilizing chamber from heating space and heating jacket from steam generator or from an external steam source. Steam from the generator or from external source is fed through a cut–off valve to the heating jacket. In turn steam, through another cut–off valve, reaches the interior of sterilizing chamber. Such a configuration makes it possible to sufficiently heat the chamber walls before its charging and closing, what in turn substantially reduces steam condensation on walls while the chamber is being filled in with steam, and reduces consequential moisturising of the sterilized items. Furthermore, separation of the chamber from heating jacket allows – prior to exposure phase – to create fractional vacuum inside, to ensure sufficient deaeration of the charged chamber, and – following the exposure phase – to generate negative pressure ensuring rapid drying of the charged material. During drying process, both in the steam generator and in the chamber the steam operating pressure is maintained, to make the sterilizer readily available for another sterilizing cycle. This ensures maximum efficiency and an uninterrupted operation of the unit. The sterilizing chamber is equipped with two measuring connections for validation procedure: test connection for pressure gauge – pipe thread acc. to ISO 228–G 1/2 A, and connection for temperature sensors – pipe thread acc. to ISO 228–G 1 A. Practical Door Chamber door, in a form of flat, rectangular finished slab is guided on rails. Rails are provided with special interlocks to prevent door fall in case of actuator pressure failure. The interlock is released for opening the chamber by compressed air. The door opens under its own weight once the pressure is released from the actuators. It is possible to stop the door in any position. To do so, press the emergency strip on the door upper edge. The door is opened and closed automatically, by pressing a key. The basic sealing element of the door is a gasket of round cross section, located in the chamber groove. Once a program is started, the gasket is pressed against the door by steam pressure present in the groove, what ensures a seal between the door and the sterilizing chamber. High–Performance Steam Filter The sterilizer can be externally supplied by steam. For such an application, it will be fitted with high–performance steam filter (separator), which is to separate water droplets from steam. Economic Steam Generator The steam generator is made of stainless steel and fitted with water gauge glass terminated outside the sterilizer housing front wall. The generator is provided with the so–called economic heating mode, in which two heaters are on. Six heaters operate only at the beginning of the initial process, and during the exposure phase. Ecological Vacuum Generating System The AS 66 Steam Sterilizers are equipped with efficient vacuum pump with a spinning water ring. The process liquid (water) forming a spinning ring is continuously supplied. As a result the space between vanes is leak–proof, and water is consequently removed together with air being pumped out of the chamber. In order to reduce water consumption, the process liquid is separated from air and reused. The vacuum generating system allows to achieve negative pressure equal or less –93 kPa (7 kPa of the absolute pressure). Air is removed from the sterilizing chamber by means of fractioned vacuum method. During that phase multiple pressure changes take place in a pre–programmed manner, ensuring effective air removal from various charge types. At the same time the charge is preheated. The deaeration phase comprises several repeated stages. Each stage commences by achieving required negative pressure, followed by pulsatory steam rinsing followed by steam supply. Efficient Air Filter Programs involving vacuum drying phase at the end of sterilizing cycle require air to be drawn into the sterilizing chamber from the immediate atmosphere. Therefore, the AS 66 Steam Sterilizers are provided with sterile air filter, which stops not less than 99.999% of particles larger than 0.30 µm. Control System The sterilizer and the built–in steam generator are controlled by the microprocessor ESS–405 controller, designed by ELMI especially for the needs of automation systems in steam sterilizers. All the operations: feeding steam into the chamber, maintaining constant exposure phase temperature, cycle progress, door opening and closure, and – in case of built–in steam generator – automatic filling of the generator boiler with water, maintaining constant water level in the boiler, controlling the operation of heating elements in a manner to ensure keeping constant steam pressure, are continuously managed by the control system. There are sterilization programs and test modes permanently saved in the controller’s memory namely: Bowie–Dick test and sterilizing chambers air leakage test. The control system is provided with self–test mode which can detect over 60 scenarios of sterilizer operation: • Supply media levels (water, air, steam) – shortage of any is responded to • Pressure under the door gaskets • Correctness of door opening and closure • Analogue sensor system – shorting or opening of individual sensor and exceeding measuring range is signalled • Status of individual automation system components i.e. such as: contactors and door interlocks • Exceeding set up pump operation time • Selection of components prior to assembly Response to the malfunction detected varies depending on location of fault (i.e. which of the control system components operates incorrectly), time of occurrence (another reaction can occur during sterilizing process or anytime), and on the extent to which it affects the proper process. The decision on how to respond is made automatically in the sterilizer control system. The fault messages are displayed on the control panel. • Moisture and temperature sensors to warn the operator any time the environment parameters of the controller are exceeded Modifications of the program parameters are protected by password, which must be entered to allow modification to be made. Another code allows access to service menu. • Controller testing procedures Additionally the so–called ‘intelligent keypad’ solution has been incorporated, in which only those keys are active which are currently used by the control system. The others, despite being pressed, stay inactive (e.g. only stop and process parameter display keys are active). The reliability of the controller is ensured by the following: • Surface assembly technologies SMD Sterilizer Control Unit (Clean Side) Process Recording On the clean side of the sterilizer a control panel is located. The panel includes: The lower part of the control panel houses a printer which cooperates with sterilization cycle parameters recording unit, which is independent from the control system. • LCD display with touch–screen • Program selection keys • Program start and termination key • Door operation keys • Emergency process termination key The cycle parameter recording system meets the EN 285 standard requirements, in terms of digital registering instruments. The inlet and outlet circuits, read and write accuracy and operational algorithms ensure conformance to all other requirements of the a/m standard. • Sterilizing cycle change key All basic (required) sterilizing cycle parameters – listed below – are subject to recording and printing: • Mains switch • Temperature in the chamber • Emergency switch • Pressure in the chamber • Printer • Date and time of cycle start The LCD display (colour graphic display with touch–screen feature) provides complete information on the process parameters and at the same time serves as an accessory keypad. The display provides the following information: • Parameters of selected and executed program • Selected program number • Current sterilizing cycle phase (including division into individual stages of given phase) • Progress of the current phase during a cycle • Value and type of parameter necessary to complete given stage or phase (set parameter, e.g. exposure temperature or duration) • Current values of temperature (with accuracy reaching 0.1°C) and pressure present both in the chamber and sterilizer jacket • Duration of the current sterilizing cycle, counted from the beginning, as well as duration of the active phase in a given cycle and of the subsequent stage during a phase, time remaining until phase completion (e.g. during exposure or drying phase) • Sterilizing cycle temperature and pressure inside the chamber – in a form of graph • Messages on malfunctions detected by automatic control system during operation of the equipment – information for operators • Statistical data concerning individual sterilizer, such as: number of the cycle performed, number of the cycle within a given day, dates of last test programs, sterilizer operation time • Sterilizer identification data: type, manufacture version, factory number, date of manufacture etc. Additionally, the display serves as an accessory keypad (active touch–screen), once an additional password is entered the following additional data will be displayed: service menu, maintenance and configuration data including calibration setting options. • Sterilizing cycles counter • Sterilizer identification data (type, factory number, date of manufacture) Additionally, the printout will include: • Messages relating to malfunctions detected during equipment operation by the automatic control system • Sterilizer operation time • Number of cycles executed within a given day • Last Bowie–Dick test execution date • Last air leakage test date • Summary including detailed durations of particular phases of sterilizing cycle and information on the correctness of cycle progress • Sterilizer user identification (e.g. hospital name) Once the sterilizer is turned on, the recording unit automatically prints all cycles executed in the sterilizer, including Bowie–Dick and air leakage tests. The only user–intervention required is to replenish paper in the printer bin and to change ink ribbon anytime the print quality gets low. The process data printing is effected synchronically after any sterilizing cycle is activated. The operator has no possibility to interfere with recording process of the sterilizing cycle data. The device requires no control operations by the staff – recording process is fully automated. Sterilizer Control Unit (Sterile Side) The control panel of the sterile side includes signalling fields, which display current sterilizing cycle progress, condition of doors on the clean side and occurrence of faults, door operation and emergency process termination pushbuttons, as well as the emergency switch. The control panel is provided with the emergency switch, having two functions: • While the door is moving, pressing the button causes the door stop instantly; alarm message is displayed • During the sterilizing cycle, pressing the button stops the cycle – all valves supplying media to the chamber will be closed Cooperation with an external PC system Each sterilizer can operate in computer network environment. As an optional feature, SMS offers the MEDOK system – special dedicated software created by ELMI, and designed for evidencing operation of individual sterilizers or central sterilizing departments. The main component of the system is the module called “DOKUMENTATOR”. The program automatically evidences operation of the entire sterilizer (cycle data, sterilizer configuration data, service data and many others) by writing them on a computer hard disc in a protected database. The evidenced data can be recalled in various screens which are defined based on the data displayed. During the sterilizing cycle, the application delivers comprehensive information on the process progress in a form of progress bar and messages. The software can be also used for registering and evidencing operation of an entire central sterilizing plant. Versatility of the application consist not only in the possibility to connect sterilizers, but also other equipment, such as washing units, disinfectors, and rotary welders. The DOKUMENTATOR application allows also data transfer in other formats (such as xls – MS Excel format), and provides opportunity to analyse the stored data, making lists, reports and printouts. TECHNICAL SPECIFICATIONS Type Total sterilizing chamber capacity Usable space dimensions (width, height, length) Load capacity of the chamber with standard charge units (300x300x600) Overall dimensions width height depth Weight PA version* WPA version Sterilizer weight during water test PA version WPA version Sterilization temp. dm3 mm STE mm kg AS 666 AS 669 AS 6612 AS 6618 334 459 605 897 662x662x950 662x662x1250 662x662x1850 4 6 8 12 1170 1900 970 780 850 1170 1900 1225 950 1050 1170 1900 1525 1150 1250 1170 1900 2125 1750 – 662x662x694 1130 1400 1750 1200 1500 1850 °C programmable within the range 110÷138 Supplying media Water steam – supply pressure 2,5 bar max consumption kg/min 0,9 1,2 1,5 avg. consumption kg/cykl 8,5 11 13 Water – condenser and vacuum pump supply – supply pressure 1÷6 bar 25 25 25 max consumption dm3/min avg. consumption dm3/cykl 100 100 150 Water – steam generator supply – supply pressure 1÷6 bar – WPA version 5 5 5 max consumption dm3/min 3 avg. consumption dm /cykl 10 13 15 Compressed air – supply pressure 5÷8 bar Capacity Ndm3/h 600 600 600 Power rating – 3N~ 400V; 50Hz Installed power PA version 2,5 2,5 2,5 kW WPA version 36+2,5 36+2,5 36+2,5 Heat emission PA version 3,2 3,8 4,4 kW WPA version 3,6 4,2 4,8 Sound dB (A) <65 power level Max allowable chamber bar 2,8 pressure Max allowable °C 142 chamber temperature kg * PA - one-sided with no steam generator; WPA - double-ended with built-in steam generator 2820 – 1,8 16 25 200 – – 600 2,5 – 5,7 – SMS has been present in the medical equipment market for several dozen years. The company’s core activity comprises manufacturing steam sterilizers. In addition the offer includes complex solutions and supplies of disinfecting and sterilizing equipment together with necessary accessories, such as: special furniture, water treatment systems, steam generators, welders for sterilizing packages and consumables for sterilization. Equipment offered by SMS meets all requirements of valid Polish and European standards. The sterilizers have necessary certificates and approvals, such as the Certificate of Compliance with Medical Directive 93/42/EEC and the Certificate of Compliance with the Pressure Equipment Directive 97/23/EC. Also the EN 285 and EN 554 standards are conformed with. The quality management system in accordance with ISO 9001:2000, implemented and maintained in the company, ensures highest quality of performance at any stage of activity: design, manufacturing, assembly and service. Consulting services SMS offers consulting in the scope of selection of equipment to suit clients’s individual needs. Also assistance is available in designing complete central sterilizing plants or sterilizing departments in operation blocks, hospital departments, milk kitchens etc. 8 Konstruktorska Str., 02-673 Warsaw, Poland tel. +48 22 843 27 61, fax +48 22 843 28 81 e-mail: sms@sms.com.pl, www.sms.com.pl