FVA/A1 STERILIZERS

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2. SAFETY IN OPERATION 2.1. INTENDED USE ! WARNING! FVA/A1 - OPERATION AND MAINTENANCE MANUAL It is absolutely forbidden to use the sterilizer and its accessories for any use other than the allowed use specified in this manual. Depending on the chosen configuration, these sterilizers are capable of sterilizing solids and liquids by using various sterilization processes. In its basic configuration, the machine is suitable to process the following products. Sterilization of solids: - empty laboratory glassware; - stainless steel instruments, in bags or loose; - machine parts; - small stainless steel containers; - miscellaneous laboratory material; - delicate membranes and filters; - solid laboratory waste in open bags or contaminated liquids (materials that can cause microbiological contamination on the part of viruses or bacteria of the surrounding environment). Sterilization of liquids: - liquids and culture media (agar) contained in non-hermetically closed containers; - various solutions contained in non-hermetically closed containers; - various solutions contained in small hermetically-closed containers. 2.2. PROHIBITED USE ! WARNING! All uses that are not specified explicitly in the previous subsection must be assumed to be prohibited. It is necessary to avoid treating the following materials: - flammable or explosive substances; - non-flammable liquids that have a high vapor pressure (halocarbons and the like), even in closed containers; - gas in bottles and spray cans (even if the cans are depleted because they have been used up); - substances that due to decomposition caused by moist heat can generate toxic, noxious, flammable, or explosive gases or vapors or can generate flammable, noxious, toxic solids or residues. ! WARNING! Moreover, since the sterilizing effect is ensured by the direct or indirect contact of water vapour with the surfaces to be treated, moist-heat sterilization processes are accordingly not suitable for treating: - closed vapor-impermeable containers whose interior is to be sterilized (for example closed empty ampoules); - closed vapor-impermeable containers containing an anhydrous material to be sterilized (for example ampoules containing anhydrous oily substances and anhydrous powders). When in doubt, it is advisable in any case to consult FEDEGARI beforehand. ID no. 85693 Rev. 2 6 / 31 July 2005
FVA/A1 - OPERATION AND MAINTENANCE MANUAL 2.3. GENERAL POTENTIAL DANGERS ! WARNING! Most workplace accidents arise from failure to observe the most elementary safety rules. Anyone working on the machine must know perfectly the rules given in this document and on the WARNING! plates and comply with them. It is strictly necessary to comply with the general rules given hereafter. The input terminals of the power supply line are live even when the main switch is disengaged (“OFF” position). It is absolutely forbidden to disable for any reason the safeties installed on the machine. Only personnel of the manufacturer FEDEGARI, or, following authorization by FEDEGARI, qualified personnel of the user can perform reduced-safety operations. Before proceeding to use the sterilizer, ALWAYS check that the materials to be processed are compatible with the cycles and steps provided by the sterilization program that you intend to start. Check in particular that the materials do not have an inherent risk of molecular instability that may cause explosions as a consequence of handling or processing. Do not carry out work or modifications of any kind on the machine or on its accessories. Do not modify in any way and for any reason parts of the sterilizer in order to adapt additional devices or other items to them. In case of malfunction/accident due to failure to comply with this prescription, FEDEGARI is not responsible for the consequences. You should contact FEDEGARI in case of requirements regarding modifications to be made to machine. If the machine is equipped with the optional kit (Safety thermal locking device), ALWAYS position accurately, and as specified hereafter, the heat probe, which also acts as a safety for the chamber opening temperature. Always pay great attention to the temperature indication on the display, because: � when placing the heat probe among the bottles (not inside them) of one of the lowest layers of the load, the heat probe is able to detect the temperature of the sterilization chamber, and therefore it is NECESSARY to take into account the delay with which the liquid inside the bottles reaches the temperature displayed by the heat probe. This delay is directly proportional to the volume of the bottles. For 50-cc bottles, it is NECESSARY to consider a safety margin of at least 30°C (for bottles having a larger volume, this margin must be greater), and therefore the chamber must be cooled to a temperature of at least 40°C in order to admit that the internal temperature of the bottles is not higher than 70°C, which is the normally acceptable value. � When placing the heat probe inside a bottle immersed in the liquid contained by the bottle, it is not necessary to consider safety margins, but there is still the risk that the reference bottle might break during the process and that therefore the indication of the heat probe again refers to the chamber rather than to the inside of the bottle. Before starting a sterilization cycle, absolutely always check that the manual discharge valve is perfectly closed. Fire-fighting means of the CO2 type are recommended for fire prevention. It is absolutely forbidden to use the sterilizer and its accessories for any use other than the use allowed and specified in this manual. These sterilizers are not electromedical devices. Any installation of these machines in the vicinity of areas containing electromedical devices must be assessed as regards the maximum levels of electromagnetic interference tolerance of such devices. If electromedical devices characterized by low immunity to interference are present, it is advisable to connect the power supply lines of these devices and of the sterilizer on separate circuits. FEDEGARI autoclaves have been subjected to measurements in order to determine the maximum level of electromagnetic noise emitted by conduction and the level of immunity to interference from a typical installation environment. The results are given in the “EMC SPECIFICATIONS” subsection and comply with the required standards currently in force for industrial and civil environments. ! WARNING! Suitable WARNING! plates are placed onboard the machine to indicate potential dangers. The symbols used comply with European standards. July 2005 7 / 31 ID no. 85693 Rev. 2
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