FVA/A1 STERILIZERS

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1. Model 2. Serial number 3. Year of manufacture 4. Code of notified body for 97/23/CE directive 5. Code of notified body for 93/42 directive (if applicable) Figure 3.3 – CE identification plate 3.4. KEY COMPONENTS OF THE MACHINE The sterilizer is composed of the following main components: - sterilization chamber; - lid and sealing system; - cabinet of technical area; - electrical system; - electrical panel; - hydraulic and pneumatic system; - electronic process controller with integrated operator panel; - electric compressor for gasket pressurization; - steam generator with built-in supply pump; - condensate heat recovery system; - product loading/unloading devices. � NOTE Please refer to the technical manual of the machine for a detailed description of these components. FVA/A1 - OPERATION AND MAINTENANCE MANUAL 3.5. MAIN ADDITIONAL (OPTIONAL) COMPONENTS OF THE MACHINE The basic configuration of the sterilizer can be fitted with a series of optional components (kits). � NOTE Please refer to the technical manual of the machine for further information on additional component kits. 3.6. CONTROL AND MONITORING DEVICES The sterilizer is controlled by means of a system constituted by a PLC. The PLC manages the main actuation systems, supervises and monitors the hardware that constitutes the machine, and organizes the activation of the operating sequences (phases) that relate to the specific programmed sterilization “cycle”. The PLC, also termed “process controller” CVB2000 hereafter, has been developed specifically to ensure automatic operation of Fedegari’s saturated-steam vertical sterilizers of the FVA/A1 series. The system is based on a SITEK PLC, which is integrated into the operator panel, to which it is connected by means of a serial port. It is extremely simple to use even for personnel lacking information technology skills and allows to start and control the sterilization cycle stored in memory. All information regarding the cycle is also printed by a small optional process printer, which is located below the operator panel. The machine is also provided with control/monitoring components, which complement the tasks of the PLC independently of the PLC itself for certain control/monitoring functions. ID no. 85693 Rev. 2 12 / 31 July 2005
FVA/A1 - OPERATION AND MAINTENANCE MANUAL 3.6.1. CONTROL AND MONITORING STATIONS The sterilizer is equipped with functional components and assemblies for control/monitoring located on the body of the machine. The control and monitoring components of the machine are: - process controller (with integrated operator panel and touch-screen); - main switch; - emergency pushbutton; - vacuum gauges for chamber and generator monitoring; - manual discharge valve. By standing, the operator can operate easily and can access indications or messages in a very straightforward manner. � NOTE Please refer to the technical manual of the machine for a detailed description of the control and monitoring components 3.7. SAFETY SYSTEMS 3.7.1. DESCRIPTION OF THE CHAMBER CLOSING AND OPENING SYSTEM Initial conditions of the system Before the chamber is closed, and until the lid has reached the position intended for this purpose, the closed-lid limit switch is in the open position and in this condition breaks the circuit that allows to introduce compressed air in the gasket seat, accordingly making it impossible - as explained later – to introduce pressurized fluids in the chamber. Beginning of the closure maneuver The lid of the autoclave is turned manually from the open position to the closed position by using both hands, thus preventing fingers from getting trapped. When the lid reaches the position provided for closure, the limit switch changes state and enables the system to send the command, allowing to introduce compressed air in the gasket seat. Chamber closure Once the clearance of the limit switch has been obtained, ensuring the correct position of the lid, if the operator presses the door locking button, compressed air is introduced in the gasket seat, starting the complete closure of the chamber and the locking of the lid. Operation of the sealing system Pushed by the compressed air, the gasket moves upward and is compressed against the perimeter of the lid, which is accordingly lifted from the inactive position and is retained by the two semicircular brackets. Compression of the gasket against the lid ensures complete closure of the autoclave and its tightness against the action of any pressurized fluids introduced in the chamber. Clearance to introduce fluid in the chamber A pressure-controlled switch detects the pressure of the air in the gasket seat. When this pressure reaches the preset value, the pressure-controlled switch reports to the process controller that the chamber is closed and in fully sealed conditions, enabling the start of the process cycle and the introduction of fluids in the chamber. Clearance to introduce fluids in the chamber by the process controller is fail-safed by a safety circuit, which checks that: - the pressure-controlled switch is reporting that the lid gasket has inflated; - the lid is in the correct position, by means of the clearance provided by the limit switch. Conditions required to start the opening maneuver To begin opening the autoclave, all the preconditions specified below must be met by the process controller: - the process cycle must have ended; - the pressure transducer connected to the control system of the autoclave and the electromechanical safety device must both report that the pressure inside the chamber has returned to a value equal to the atmospheric pressure; July 2005 13 / 31 ID no. 85693 Rev. 2
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FVA/A1 STERILIZERS

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