FEDEGARI AUTOKLAVEN AG FoR sats NBA og aul FEDEGARI AUTOKLAVEN AG‘ is a brand manufactured by : (F] FEDEGARI (SUISSE)SA © Vie alla Gerra, 11 + CH-6990 Bedano ~ SWITZERLAND ‘@ +41 (0)91 9352090 - B +41 (0)91 9352099 - B http:/hwww.fedegariautoklaven.chAUTOCLAVE NBA1 O8AW Model : FOB4-TS Power : 400v 3Ph +PE 50 Hz FEDEGARI AUTOKLAVEN AG? is a brand manufactured by : FEDEGARI (SUISSE)SA 3 Via alla Gerra, 11 +» CH-6930 Bedano - SWITZERLAND ‘@ +41 (0)91 9352090 + B +41 (0)91 9352099 + B http://www fedegariautoklaven.ch IKX10) [Steam generator wu 1KX20 | Vacuum pump. a 1X30 __[ Condensate cooling unit Oo KX40_ [Internal air compressor a 1KX50_| Sterile air fiter KKXS1_ | Unit for supplying compressed air from the mains a “Kx52_| Rapid cooling unit oOo KXx61_| Chamber pressure tightness test er oO KX62__| Decontamination cycle o KX63__| Decontamination cycle with discharge air filter a KX67_| Slow vacuum oO Kx68_| Super dry o KX69_| Air/steam counter-pressure cycle aa oa KX70__|Kitfor conformity with European medical directives oa KX72_ [3161 st. steel mains steam supply o 1073 _ | Airfiter indine sterilization with 316L st. steel housing oa KX75__|EN285 steam quality test accessories oa KX80_ | Additional P1100 a KXx81__| Printer ee a KX82__| Datalogger ii ag KX84__| Safety thermal locking device oa [External Independent paperless recorder 6700A compliance to CFR2T roasa EAT a KX90__| Second door software management : wa KXx91_| Port adapter for validation sensors a KX93_| Hygienic GMP connections for chamber pressure transducer and gauge o KX102 _| External recording kit Oo KX104__| Tap water and compressed air inlets control system oO TX31_| Replacement cartridge for the deioniser oO ‘SFX1__| Optional Bloseal Special Sealing Flange ot o ‘SWX1_| Fo Function caloulation and control x ‘SWX2_| FOB Link (Ethernet connection)FEDEGARI AUTOKLAVEN AG a SWX3 _| Cycle repetition oa ‘SWX6_[ FOB Logger for conformity with FDA CFR21 Part (Ethemet connection) oO ‘SWX8_| Warm up and warm keeping programs a SWX10 _| Cycle archiving oO ‘MOX1_| Additional standard user manual copy oO ‘MX02__| Kit of extra documentation (Calibration certificates, fiters certificates) oO MX03__| MX02 plus material declarations, welding log, roughness certificate o MX05__ | P&ID and Electrical wiring diagram as built a oO MX06__ | Functional Design Specification oa SAX1_| Software assurance statement oa ‘SAX2__ | Software assurance statement including audit NOTES FEDEGARI AUTOKLAVEN AG? is a brand manufactured by : FEDEGARI (SUISSE)SA [4 Via alla Gerra, 11 - CH-6930 Bedano - SWITZERLAND B +41 (0)91 9352090 + 2 +44 (0)91 9352099 + & hitp:/hmww fedegariautoklaven.chFEDEGARI. IO : USE AND MAINTENANCE MANUAL STERILIZERS SERIES FVA/A1 — FOB2-3-4-5 TS FEDEGARI AUTOCLAVI S.p.A, FEDEGARI (SUISSE) SA S525 ka 6 27010 AB (tala. Vin a Gone, 41 CH 8290 Bacaro_ Sutcacare ‘@ +390382434111 - B +390382434150 +41 (O91 9952090 on (o)s1 9952099 i httovAwww fedeaeri com lw fedegariautoklaven ctFVAJA‘ ~ FOB2-3-4-5 TS USE AND MAINTENANCE MANUAL &) FEDEGARI REGISTRATIONS, ADDITIONS, AND VARIANTS FUNCTION | NAME DATE ‘SIGNATURE : Technical WRITTEN BY: hee F.Pozzi | 30-MAR-2014 Ss SS é TECHNICAL CHECKED BY =| GENO |F. Fusi 30-MAR-2014 1 coe CHECKED AND | QUALITY APPROVED BY: | MANAGER |" Seat! | 90-MAR-2014 ed REVISION __DATE DESCRIPTION 1 30-MAR-2014 | FIRST EDITION FU 3463714 rae arch 2014USE AND MAINTENANCE MANUAL : — (E) FEDEGARI TABLE OF CONTENTS Chap. 1. FOREWORD. 11 IDENTIFICATION OF THE PUBLICATION 1.4.1 Related Publications... 1.2 PURPOSE OF THE PUBLICATION. 1.3 REGULATORY FRAMEWORK. 14 USE OF THE MANUAL 1.5 UPDATES... 18 IDENTIFICATION... 1.7 TECHNICAL SUPPORT SERVICE. 1.8 _ MANUFACTURER'S GUARANTEE 1.9 ACRONYMS AND TERMS....... Chap. 2, _ GENERAL DESCRIPTION 24 TYPES OF STERILIZERS 22 SPECIFICATIONS. 23 SAFETY SYSTEMS 23.1 Chamber Closing and Opening Syste (Series FOB45 TS) 23.2, Chamber CoverDoer Closing and Opening... 23.2.4 Initial System Condition... 2322 Starting the Closing Maneuver. 2.3.2.3 Completing the Closing Maneu 23.24 Sealing System Functioning. 2.32.5. Authorization to Introduce Fluid into the Chamber. 23.26 Conditions Necessary to Stat the Opening Maneuver 2.3.27 Defetng the Sealing Gasket Seat... 2328 Opening the Chamber. 233° Safety Valves 23.4 Air Sealing Gasket System. 24 ELECTRICAL SYSTEM 25 HYDRO-PNEUMATIC SYSTEM. s 26 ELECTRONIC PROCESS CONTROLLER. i 27 MAIN SUPPLEMENTARY COMPONENTS (Options). 2.7.1 Bioseal Special Sealing Flange (optional isolator panel). 37 27.2 Four-Leg Semi-Mobile Bench - Option 00.0.0 : 38 2.8 PROCESS INFORMATION a4 29 INTENDED USE. a4 2.40 UNFORESEEN USE 45 2.41 TRASPORTATION, HANDLING, AND STORAGE...... 46 2.11.1 Transportation... 2.11.2 Storage. 2.11.3 Handing... 2.12 _ INSTALLATION 2.121 Removal of Protective Materials... 2.12.2 Positioning of the Sterilizer... 2.123 Connection to Energy Sources and Utities 2.12.4 Hydraulic Connections... a 2.12.5 Connection to Power Supply. 2.12.6 Guided Installation... 2.127 Installation Check and Installation Report Chap. 3. STERILIZER SAFETY 3.1. GENERAL SAFETY NOTICES, 3.1.4 Fire Prevention... : 3.1.2 Materials to Clean the Sterilizer Chamber and Other Parts . 3.1.3. Wamning Plates... a Se a WFUsTOaTT ae Maren 2014Use AND MAINTENANCE MANUAL : (E) FEDEGARI 3.1.4 Operators 3.1.4.4 Operator Qualifications a... 3.1.4.2. Maintenance Technician Qualifications. 3.1.5 Personal Protection Equipment (PPE)... 3.1.6 Recommendations and Safety Measures atthe customer's Care. 3.1.7 Emergency Situ A741 Electrical Black-oUt on ‘21.72 Fallure of Weter, Steam and Proumailc Supples. 2.1.73. Emergency Stop . 3.2. RESPONSIBILITIES OF THE MANUFACTURER 33 SAFETY SYSTEMS INSTALLED.... 3.3.1 Access to TESIC Configuration (Option KX84). 3.3.2 Configuring TESIC Control Unit. 3.3.3 Calibrating TESIC Unit 3.4 RISKS RELATED TO SOFTWARE USE 35 RESIDUALRISKS....... 3.5.1 “HIGH PATHOGEN’ Risk from Heavily Contaminated Materials... 3.5.2 Compatibility Risk with Process Materials... 3.53 _ Risk of High Temperature in the Chamber before Door Opening. ‘3.5.3.1. Checking Correct RTD Probe Positioning in the Chamber... Ete 3.54 Risk fom Unforeseen Use with Low-Boiling Liquids andlor Liquids That Are Flammable in Air... 68 3.5.5 Chamber Pressure Risk / Pressure Relief Hand Valve (V.M.). 2 63 3.5.6 _ Risk of Crushing Upper Limbs in Semi-Automatic Swing Doors .... 69 3.6 OPERATING ENVIRONMENT......0s0nnns . 70 3.6.1 Illumination 7 70 3.6.2 Environmental Conditions. 70 3.6.3 Use outside Ambient Conditions Allowed .. 70 3.7 NOISE AND SOUND PRESSURE. Chap. 4, CONTROLS AND INDICATORS. 44 FUNCTIONING OF THE STERILIZER 4.2 SOFTWARE STRUCTURE 43 GENERALITIES........ 44 COMMAND & CONTROL ELEMENTS / CONTROL STATION. Chap. 5. USING THE STERILIZER .. 5.4 OPERATOR INTERFACE. 51.1 Entering Data 52 OPERATING MODES AND ACCESS LEVELS. 521 Access Levels - 5.22 Operating Modes, 53. OPERATING PROCEDURES AND NOTICES FOR USE 531 Generalities ne 53.2 ProcedUres.onnunn 63.3 Operating Phases . 54 POWERUP.... 5.4.1 Checking Supplies... 5.4.2. Power-up Sequence... 55. ENABLING STERILIZER OPERATION. 5.5.1 Access to the Process Controller. 5.52 _Logrin through iButton (Option SWX8) 5.3 Chamber Pressure Check 554 Preliminary Checks 5.6 LOADING THE PRODUCT 5.6.1 Loading Series FVAVA1-«. 57 DOORICOVER CLOSURE 58 CYCLE START AND PROGRAM EXEGUTION NFU sae aie March 2074FAA -F0B2-3-4.5 TS USE AND MAINTENANCE MANUAL - FEDEGARI 5.8.1 _ Considerations on Programs and Work Cycles.. 5.9 “STEP BY STEP" AND “STOP CYCLE" FUNCTIONS... 5.10 EMERGENCY PHASE........ 5.10.1 Exit from Emergency and Black-out Conditions. 5.11 PROCESS CONTROL. - 5.11.1 Messages. 5.11.2. Management of Alarms and Messages 5.12 SYSTEM RESET. 5.13 END OF TH STERILIZATION CYCLE... 5.14 UNLOADING THE PRODUCT. 3 515 OPENING THE DOORICOVER AND REMOVAL OF THE LOAD FROM THE CHAMBER 5.46 SHUTDOWN 5.16.1 Nomtal StOP on 5.17 EMERGENCY STOP 548 PROLONGED STOP....... = 5.19 RESTARTING THE STERILIZER AFTER AN EMERGENCY STOP 5.20 _ SETTING OF PARAMETERS. 5.20.1. Program Parameters... 5.20.2 Autoclave Parameters. 5.21 ANCILLARY FUNCTIONS. 6.21.1 Calender. '6.21.1.1 Entering 8 Calondor Event. 8.21.2 Logbook... 21.2.1 Viewing a Logbook Record... 5.21.3. Backup & Restore 5.21.3. Data Backup .. 5.21.32 Data Restore... 5.21.3.3 User Restore. = 8.21.4. Storing Archived Cycles in a USB Key (Option SWX10)... 5.21.5 Upgrading the Sterilizer: Option Code Input. '6.21.6.1 Checking Option Activator 5.22 ALARMS AND TROUBLE-SHOOTING .. 5.22.4 Alarms. 6.22.41 Live Alarms ou 1.2.1.2 Alarms History \ 5.22.2 Troubleshooting Table Chap.6. MAINTENANCE AND REPAIR..... 61 GENERAL NOTICES... 62 FOREWORD... 7 63. PREVENTIVE MAINTENANCE 6.3.1 Generalities and Cautions 6.3.1.1. Preliminary Operations. 6.3.2 Cleaning the sterilizer 63.2.1 Cleaning the Chamber. 632.2 Gleaning the Chamber Filter 632.3 Cleaning Load and RTD Probes: 63.24 Cleaning Operator Interfaces. : Gleaning the Door and Outer Panels... ‘Cleaning Product Conveyance Trolleys (Option). 6.3.3. Regular Efficiency Checks. WFD SsTORT Bree ‘March 2074FVA/A1 - FOB2-3-4.5 TS USE AND MAINTENANCE MANUAL i LIST OF FIGURES Figure 1-1 — CE plate and nameplate, . Figure 1-2 — Location of nameplates — Series FVAAT .. Figure 1-3 — Location of nameplates ~ Series FOB2-3-TS. Figure 1-4 — Location of nameplates — Series FOB4-5-TS Figure 1-5 ~ General references of the sterilizer : Figure 2-1 — Sterilizer Series FVA/A1 Figure 2-2 — Sterilizer Series FOB2-TS. Figure 2-3 — Sterilizer Series FOB3-TS Figure 2-4 - Sterilizer Series FOB4-TS.. Figure 2-5 - Sterilizer Series FOBS-TS...... Figure 2-6 - Chamber closing and opening Figure 2-7 Sealing system with special sealing gasket Figure 2-8 ~ Electrical panel Figure 2-9 ~ Series FVAVA1 — Load lifting aid (Option KX83) Figure 2-10 — Series FVA/At Selt-ocking loa liting ad (Option x9) Figure 2-11 — Series FOB3-TS — External trolleys — Type ‘A’... Figure 2-12 — Series FOB3-TS ~ External trolleys — Type “A Figure 2-13 — Series FOB4-5-TS — External trolleys - Type “A’ Figure 2-14 — Internal trolleys — Type "B" Figure 2-15 — Internal trolleys ~ Type °C... Figure 2-16 — Handling of Series FVA/A1 ~ Removing the locking devices. Figure 2-17 — Handling of Series FVA/A\ ~ Laying the sterilizer on the floor using the chute supplied... Fgure 2-18 ~ Handing of Seles FOB2-2-TS and FOB4-5-TS - Removing the locking devices Figure 2-19 — Handling of Series FOB2-3-TS..... : Figure 2-20 — Handling and positioning of Series FOB4-5.TS, Figure 2-21 — Handing of Series FOB4-5-TS — Lifting points. Figure 2-22 — Leveling - Series FOB4.5-TS Figure 5-1 ~ Page showing the FEDEGAR! LOGO Figure 5-2 ~ Page "Monitor". Figure 5-3 ~ Log-in page .... = Figure 5-4 — iButton and socket for logging in (Gption SWX8), Figure 5-5 — Parameters menu page...» Siz Figure 5-6 - Chamber pressure self-learning page Figure 5-7 — Sterilization chamber and jacket — Drain fier. Figure 5-8 - FVAA1 ~ Loading the product. Figure 5-9 — FVAJA1 — Basket iting and hooking.. Figure 5-10 ~ Cover closure page... Figure 5-11 — Page "Monitor" — Cover clos Figure 5-12 ~ Door closure page... Figure 5-13 ~ Page "Monitor’ — Door closed Figure 5-14 ~ Program selection page .. Figure 5-15 — Groups of programs selection page. Figure 5-16 ~ Data input page. Figure 5-17 ~ Preparation page. . Figure 5-18 — Page "Monitor" Figure 5-19 ~ Black out alarm or emergency red button pressed dung ‘a sterilization cycle. Figure 5-20 ~ Sterilization cycle end a ze Figure 5-21 ~ Sterilization cycle end — Cycle OK. Figure 5-22 ~ Sterilization cycle end ~ Cycle OK. Figure 6-1 — Chamber fiter cleaning .. Figure 6-2 ~ RTD probe. MEU 368714 one March 2074USE AND MAINTENANCE MANUAL z FWA ~Fon2a45 78 {E) FEDEGARI LIST OF TABLES ‘Table 1-1—Acronyms and uncommon terms... ‘Table 2-1 - Types of sterilizers Table 2-2 - Steriizers — Operating specifications and types of materials... Table 2-3 - Sterilizers - Technical specifications Table 2-4 ~ Sterlizers — Technical specifications and consumptions Table 2-5 - Sterilizers - Optional KITS... Table 2-6 - FVA/A1 ~ Geometrical data of load lifting aid (Option 69) Table 2-7 — External trolleys / Examples. Table 3-1 - Waming plates against potential hazards... Table 3-2 — Personal protection equipment for sterilizer operators on Table 3-3 — Personal protection equipment for maintenance technicians... Table 3-4 ~ Safety device specifications by sterilizer series Table 3-5 — Typical TESIC factory settings. Table 4-1 — Command and control elements of the sterilizer. Table 6-1 — Operator-based preventive maintenance.....cnennnnnnnn MaFU-SsT0sT4 Tie March 2074USE AND MAINTENANCE MANUAL - FvAIM ~FoB20457 &) FEDEGARI PAGE INTENTIONALLY LEFT BLANK FU AEST erie March 2014USE AND MAINTENANCE MANUAL 7 EVA ~Fos2a46 18 Te FEDEGARI Chap.1._ FOREWORD 1.1 IDENTIFICATION OF THE PUBLICATION ‘The "USE AND MAINTENANCE MANUAL" is an official document issued by FEDEGARI Autoklaven (hereinafter referred to as FEDEGAR!) and an integral part of the sterilizer. It is marked with a distinctive Document Code ‘shown in the footer of each page that allows identification, traceability and subsequent reference, if necessary, of this publication. FEDEGARI reserves the right to make changes to this manual any time without prior notice. 1.1.1 Related Publications ‘Technical manual of the sterilizer containing: + Reference manual of the DCS PLUS 10 process controller; ‘© Piping and instrumentation diagram (P&ID); © Wiring diagram; + Installation drawings; * Component data sheets; © Maintenance data sheets. 1.2 PURPOSE OF THE PUBLICATION ‘This manual is intended for the users of the sterilizers belonging to the referenced series. it contains all information necessary for correct use and regular maintenance of the machines. Proper functioning and the ‘working life of each machine, as well as preservation and protection of the safety of the operator and processed materials, depend on whether the user follows the instructions and rules herein contained carefully and rationally. Therefore, we recommend reading carefully and strictly respecting all instructions contained in this publication, All information is current as of publication date. 1.3 REGULATORY FRAMEWORK The contents ofthis publication are written in compliance with the requirements of the following standards: + ENISO 12100-2:2008. + ENISO 60204-1:2006. and with the following European Directives + PED — 97/23/EC (Pressure Equipment Directive) + MD 2008/42/EC (Machinery Directive). + LVD —2006/95/EC (Low Voltage Directive); refer to EN 61010-1 and EN 61010-2-040. © EMC — 2004/108/EC _(Electro-magnetic Compatibilily); refer to EN 61326-1 (EMS industrial environments, EMI CISPR 11 Group 1 Class A). * MDD — 93/42IEC_ (Medical Device Directive). ©) sterilzers “used in heath-cerethospital environments to process medical devices before their rouse” must comply with the ENZ85 standards. To fully meet these requirements, specicaly request the instalation of Opion KX70 — MOD compliance kt to have steriizer ‘supplied complete withthe CE marking andthe Decaralon of Conformity in compliance with Directive 63/42/EC (mandatory in EU counties) ‘and the necessary harcware options. FUssTOaTT one Waren 2014FVAIA ~FOB2-3-4.5 TS USE AND MAINTENANCE MANUAL = 1.4 USE OF THE MANUAL. NOTE or Carefully keep the manual throughout the working life of the sterilizer. + Make sure that all updates received are promptly added into the publication. «The manual is an integral part of the sterilizer and as such it must accompany the sterilizer wherever this is moved, both inside and outside the facility where it is used. This manuel must be read sequentaly, that is from beginning to end, one page afer the other, the various warings and cautions must be understood and remembered ‘Since it is assumed that the operator is a person qualified for the use of the type of machine dealt with, we have omitted all information and general guidelines which must fall within the scope of the operetor’s knowledge. Within this manuel, you wil find the following precautionary symbols and statements thet inform the users ebout Particularly delicate and/or dangerous procedures. Note CD Irticate important information highlighted outside the txt ‘CAUTION Indicate a situation where poor attention or procedures cared out improperly can cause even irreparable damages to the sterilizer. Ay wanna! Is used to hi light a situation of danger to persons. For certain specific risks, the above precautionary statements are associated with other special symbols that will bbe opportunely explained in due time within the text. Such symbols reflect the labels andlor decals affixed to the machine to warn about dangerous areas or risky behaviors. Every time, before approaching the sterilizer for use and/or maintenance purposes and starting works, carefully read the above mentioned signs, messages and instructions, and understand their meanings. Keep this manual with the utmost care. Therefore, avoid whatever harsh handling of the manual and that its contents are even partially damaged. ‘The operator is responsible for immediate replacement of the manual and of all plates, labels, stickers, panels, etc,, affixed to the sterilizer and tht have been lost or damaged or become totally or partially uninteligibe. NOTE Never remove, tear, or rewrite any part of the manual for any reason whatsoever. Immediately contact the manufacturer for a possible update if operating circumstances not covered or different of those described in the manual are encountered. Keep the manual in a moisture- and heat-free place. 4.5 UPDATES ‘Any updates to this publication may be sent to the owner of the sterilizer as single sheets accompanied with instructions for adding them into the manual. The owner of the sterilizer is invited to inform FEDEGARI in case of machine transfer so that updates and/or supplements can be sent to the new owner. FU SaBTT Tore March 2018FVA/A1 ~ FOB2-3-4.5 TS USE AND MAINTENANCE MANUAL - 1.6 IDENTIFICATION Figure 1-1 shows examples of the nameplate and CE plate that are affixed to the sterilizer. In compliance with product standards, the plate stamping is indelible el FEDEGARI (SUISSE) Sa sone REA BEE leon _Cem sian rs aon es on 6 7 ve ten 1. Notified Body ID number as per Directive 7. 97/23/EC 2, Notified Body ID number as per Directive 8. 98/42/EC (PED) (if Option KX70 is fitted) 3. Sterilizer model 8 4. Sterilizer serial number 10. 5. Year of manufacture 11 6. Pressure limits allowed [ barg ] yarn. Bi Be ‘Temperature limits allowed [°C] Nominal current absorption [A] ‘Supply voltage [ V] ‘Supply frequency [ HZ ] Number of power leads Figure 1-1 — CE plate and nameplate If the sterilizer is installed in a non-EU country, the plate will make reference to local and national regulations. The CE plate is affixed to the outer paneling of the sterilizer (Figure 1-4) The plate showing electrical data is affixed into the electrical panel wFUsTOTT The arch 2074FEDEGARI FVAIA1 - FOB2-3-45 TS USE AND MAINTENANCE MANUAL = es len seg tn cre i 7 A ve iaery pan 2 & 1. Pressure vessel nameplates (PED) 2. CE Nameplate (Sterilization chamber + Steam generator — Option KX10) Figure 1-2 — Location of nameplates ~ Series FVA/A1 MPU 8463774 Taree arch 2074FvWAt ~ 0823-4578 {=) FEDEGARI USE AND MAINTENANCE MANUAL FoR2-Te-149 1. Pressure vessel nameplates (PED) 2. CE Nameplate (Sterilization chamber + Steam generator — Option KX10) Figure 1-3 — Location of nameplates ~ Series FOB2-3-TS NFUSSI0aTT Tare arch 2014FVAIM ~FOB2-3-4.5 TS USE AND MAINTENANCE MANUAL : FEDEGARI nde FREE SURES Com Cex selnanie yc ot Sa 2—F “requerey chase z te : eee Option KX10) Figure 1-4 — Location of nameplates - Series FOB4-5-TS TEU ae Tar March 2074FVNAt ~F0B2.3-4.5 TS USE AND MAINTENANCE MANUAL. - 1.7. TECHNICAL SUPPORT SERVICE FEDEGARI is fully avaliable to its customers for any action required, directly or indirectly through its local agentsidealers. Special equipment and skiled personnel are available for overhaul and repair operations. The names and addresses of FEDEGARI AFTER-SALES CENTERS in Italy and abroad can be obtained from FEDEGARI SUISSE SA. Via alla Gerra, 11» CH-6930 Bedano ~ Switzerland, ‘@ +41 (0)91 9352090 B +41 (0)91 9362099 e-mail: info@fedegarisuisse.ch © http:1www.fedegariautoklaven.ch 4.8 MANUFACTURER'S GUARANTEE To be entitled to the guarantee provided by FEDEGARI, the customer should scrupulously adhere to the precautionary measures given in the manual, and in particular: * Operate within the operating range of the plant at all times; * Camry out regular thorough maintenance and give “Objective Evidence” by entering the works carried out in the maintenance records; ‘+ Entrust the use of the plant to personnel with proven capacities and aptitude, and suitably trained to the Purpose. ‘The sterilizer is covered by the guarantee under the General Conditions of Sale of the relating contract. The warranty is void if ‘+ Repairs are carried out without the authorization of the manufacturer or of FEDEGARI After-Sales Service; © Genuine spare parts are not used; * The sterilizer is uses for different purposes than its intended use; ‘+ The instructions indicated in this publication are not observed. CAUTION FEDEGARI declines any and all responsibilities for possible faults, failures and malfunctioning resulting from the fact that the user did not follow the preventive maintenance and/or operating instructions provided by the Manufacturer in this manual. FEDEGARI declines any and all direct and indirect responsibilities deriving from: ‘+ Non-observance of the instructions, and use of the sterilizer other than the intended use as foreseen in the ‘operation manual; + Use of the sterilzer entrusted to personnel that did not read and fully understand the contents of this manual; ‘+ Use of the sterilizer not complying with applicable regulations in force in the country of installation; ‘+ Unauthorized changes made to the plant; © Unauthorized repairs, TaFUSBi08.4 Tere March 2074USE AND MAINTENANCE MANUAL : {FE} FEDEGARI 1.9 ACRONYMS AND TERMS The Table 1-1 below reports the meaning of acronyms and uncommon terms mentioned in the text of this manual, Table 1-1— Acronyms and uncommon terms ‘ACRONYMS & DESCRIPTION TERMS Sterilizer with two doors. The doors are used to load and unload the products processed ‘Side 1" and Side 2" | from a zone generally referred to as zone A to a zone B and vice-versa. in common sterilizer applications, each zone can take or not take the characteristics of sterility and in general (even though this is not a rule) if one A is sterile, zone B is not sterile and vice-versa. Obviously, applications exist where both sides are located in a sterile zone or, on the contrary, both sides are located in @ non-sterile zone. ‘+ Side 1 of the sterlizer always refers to the area (sterile or non-sterile) where there is the door for loading the product to be processed. + Side 2 of the sterlizer always refers to the area (sterile or non-sterile) where there is the door for unloading the product processed located. Zone A and Zone B These indicate the sides of the sterlizer as seen by an operator standing in front of the sterilizer control units on Side 1 or Side 2, of of the technical compartment, as it wil be specified from time to time, FRONT, REAR, RH SIDE, and LH SIDE DCS PLUS 10 Electronic unit for command & control of the sterilizer “High microbiological contamination’; generally referred to the sterilization cycles used HIGH PATHOGEN to process loads with a high microbiological risk. Chamber Pressure vessel for sterilization Load/Product Product to be sterilized Sterilizer Autoclave for sterilization Process controller _ | DCS PLUS 10 operator panel HMI Human Machine Interface, typically referring to the DCS PLUS 10 operator panel. FDA Food and Drug Administration LvP Low Volatile Particles = amount of volatile particles in a substance Gur Good Manufacturing Practice = FDA's Guidelines/inspection Checklist Hand valve (V.M.) | Chamber pressure relief valve, manually operated PU 46ST Ter March 2074USE AND MAINTENANCE MANUAL : Fat —Fon224578 &) FEDEGARI Fon-Tes46 4. Side 1— Normally used for loading on the non-sterile side, with 4. Rightchand the chamber drain box (refer to para. 6.5.4) tured towards the ‘operator and the operator panel. 2. Side 2~ Used for unloading on the sterile side (version with 2. 5. Technical compartment doors) Left-hand Figure 1-5 - General references of the sterilizer MrU-sBT0aT4 Te Twarch 2014FVN/AM ~FOB2-3-45 TS USE AND MAINTENANCE MANUAL . FEDEGARI Chap. 22 GENERAL DESCRIPTION 2.1 TYPES OF STERILIZERS . ‘Thanks to their exclusive design and improved performance, FEDEGARI sterilizers represent the third generation of lab sterilizers in terms of safety and reliability of results All models typically feature: + Safe and simple operation; High performance and flexible processes; * Automatic operation during process; + Easy to transport and to install * Compact ergonomic design. Table 2-1 — Types of sterilizers SERIES STERILIZATION AND FUNCTIONING ‘APPLICATIONS Vertical loading saturated steam lab sterilizers (with nel air/steam option) Processing of various types of loads FoB2-3-T3 Herizontal loading saturated steam compact (bench-top) including high pathogen isk materials, lab steriizers (with air/steam option) solid and liquid materials in open or sealed containers, Horizontal loading saturated steam compact lab FOB45-TS sterilizers (with airfsteam option) ‘These sterilizers are suitable for use in microbiological and quality control labs, research institutes, universities, pharmaceutical industries, hospitals and medical structures where sterilization processes are an essential equirement. Their innovative special design, use of high quality components and excellent functional characteristics facilitate maintenance operations. ‘The process controller features a user-friendly color touch-screen monitor. The fully validated management software DCS PLUS10 has been implemented to meet the widest possible range of customer requirements. BASIC COMPONENTS The sterilizer consists of the following main components: ‘+ Sterilization chamber, ‘+ Cover or door with sealing system; ‘+ Cabinet and technical compartment; + Electrical panel and system; + Hydraulic and pneumatic system; * Electronic process controller with operator panel; + Product loading/unioading devices (Option): TaFUSaTOST Taree March 2014USE AND MAINTENANCE MANUAL i valet -Fop248 78 ©) FEDEGARI PVA AMI98 1 Operator panel 6 Main switch 2. Safety lever for mechanical locking of the cover 7. Mechanical safety lock of the cover 3. Cover 8. Sterilization chamber 4, Emergency button 9 Loading basket lifting aid (Option KX83) 5. Pressure-vacuum gauges for chamber and 10 — Utlties connections steam generator control (Option KX10) Figure 2-1 ~ Sterilizer Series FVA/A1 FU. SaBaTT Bee aren 2018USE AND MAINTENANCE MANUAL, . FNM ~FoB2a.4578 IF FEDEGARI F022 T3199 41 Operator panel 5. Pressure-vacuum gauges for chamber and steam generator control (Option KX10) 2. Handwheel for mechanical locking of the door €.-—-Maain switch 3. Door 7. Sterilization chamber 4, Emergency button 8. Utilities connections Figure 2-2 — Sterilizer Series FOB2-TS MFU-SaTOST Bie March 2014FNM ~Fon2a4578 I FEDEGARI USE AND MAINTENANCE MANUAL : 083-78-140 1 Operator panel 5. Pressure-vacuum gauges for chamber and steam generator control (Option KX10) 2. Handwheel for mechanical locking of the door 6. ‘Main switch 3. Swing door 7. Sterilization chamber 4, Emergency button 8 Utilities connections 9, Hand valve (V.M.) (manually operated chamber pressure relief valve) Figure 2-3 ~ Sterlizer Series FOBS-TS FU 3463117 wane March 2014USE AND MAINTENANCE MANUAL - | YMA -Fo823.4573 (El FEDEGARI 7 6 5 a é 1 Operator panel 5. Sterilization chamber Door 6. Pressure-vacuum gauges for chamber and steam generator control (Option KX10) 3. Main switch 7. Emergency button 4. Utilities connections 8. Hand valve (V.M.) (manually operated chamber pressure relief valve) Figure 2-4 — Sterilizer Series FOB4-TS FUSSTOsTT we arch 2014FVAIA - FOB2-3-4-5 TS - fe USE AND MAINTENANCE MANUAL 2 1 Operator panel 5. Vertical sliding door 2. Emergency button 6 Steriization chamber 3. Main switch 7. Hand valve (V.M.) (manually operated chamber pressure relief valve) 8. Pressurevacuum gauges for chamber and ‘steam generator control (Option KX10) Figure 2-5 - Sterilizer Series FOBS-TS MFO. OTT Dare arch 2018FVAIA ~FOB2.3.4.5 TS USE AND MAINTENANCE MANUAL, i: 2.2 SPECIFICATIONS Table 2-2~ Sterilizers ~ Operating specifications and types of materials 6) FEDEGARI §| fel ol elol eel eelelel2| le ili = ss t els] os Modeloftenizer! = | ez] e] F)e| § lel slealesl ol Sl al gle & | 22) 8] 8/8] 8 | 3) 3) 838) 88) 8) 8) 8) 8) 3 g lezl el ele) 2 | el el eel ool 2] ol ol oie Sterilization process Saturated steam (air/steam as an option) Horizontal : Vertical sliding doors with semi-automatic Steriization chamber closing __| "aon cover |One or woringed | sigcrozmneumatic dive system. Once system Sc . reed by hand | cl08ed, the door is automatically locked by = perated by means of a mechanicalipneumatic system Process control ‘Automatic with PLC Operator interface Operator panel with 5.7” color touch-screen ‘Temperature sensors 4.wire Pt100 RTD probes, class AA IEC60751 Pressure transducer 0-5 bars absolute / 0-6 bars absolute “? 1 for the 1 for the chamber chamber 2in the two-door version Pressure-vacuum gauges 1 for the steam generator (Option KX10) Electrical panel enclosure protection tie! Inner chamber and coveridoor ASI 316 ‘Steam generator {Option KX10) aiden Certified according to European Directive 97/23/EC PED Pressure vessels iNotfied Body: TOV) Hydrauli system AISI 316L + PTFE pipes Framework/stand AISI 304 ‘Special plastic material Cabinet ‘and AISI 304 AISI 304 paneling Utilities connections: Rear side On one side. On RH or LH side (in special execution) TAT opes win Onn RRGEAT ony TUS ETE TeaFEDEGARI FVA/A1 ~ FOB2-3-4-5 TS USE AND MAINTENANCE MANUAL z Table 2-3 ~ Sterilizers ~ Technical specifications 8 dele 3] E g 2 a 3 = 2 : & | Sars 3|iz| = 5° f= B | 83\82| Pos) eel 28) 2) 22 Model of s= & Bebe a $82) S2| BE 38 Bex sterilizer | & & [es g23| Se | 25: FVAQIA1 8 ae [fom ft | tm | ate | 215 | tao ts coe ae FVA3/A1 asss | a | NA a soo | 700 | 4 175 | 340 | 875 | 120% 1905600 es FMASPLUS | aoe | ass | wa | $§ | soo | so | 1 | 200 | 498 | 1052 | sz4exrssoness Fop2ts | = | @ | na ao |o00| 1 | 173 | 256 | 370 | 790< 1004x1022 Fop2s-Ts | a0 | 7% | na aco | soo | 2% | io | sao | 370 | stost00ext516 FOBS-TS 30» 1088 «1022 weer) | | seo | 700] + | tas | aa | 205 Gier test) 7 830» 2640 1022 rouas-ts | x | m | na | % | soo | ooo] 2 | amo | aoe | 20s | sooxsoesx 916 FOB4-1S vr | ua | 2 § | eo | 60} 1 370 | 631 | e60 | seantastx955 poset ta | i'l aa ieee || toca [nl fc | an FOB4S-TS/ ny 3 “0 1 Foeeens | 2% | 20 |r| £ | wo | oso] ze | sw | ee | seo | sxoezosze : FOBS-TS ear | 400 6 E so | 890 1 aso | 1510 | 918 | 1300x 1950x1228 Fops-ts | so | so] @ Z| ew frm] 1 | aso | s040 | o10 | 190% 1950.1708 rossc-1s | ser | sez | ann] & | ono | oo) + | 220 | 1200 | ose | ra00st280x1108 3 Fopss-1s | o0 | wo | 6 220 | 1000] 2” | 950 | 640 | 918 | 1200% 1980. 1408 FOBSSL-TS | us | so | 8 20 | 1250] 2 | 1000 | 1045 | o18 | 1300x 1050. 1650 FoBS-xL | 2080 | 70 sso | 1751] + | 1080 | 2100 | 18 | 1900% 1950x 1957.5 FOBSS-xL_ | 200 | 70 so | 1618] 2 | s100 | 2100 | 918 | 1900% 1950. 1200 (Haight From oor. (2) Outer dimensions with cover closed. {G) Bioscal on steric side (se0 pare. 2.7.1). (2) Biosesl on both sides (see pare. 27.1). TRU 463717 Brae arch 2074FVM ~ FOB2-3-4.5 TS USE AND MAINTENANCE MANUAL, - Table 2-4 ~ Sterilizers ~ Technical specifications and consumptions [E)FEDECAR Model of sterilizer FVAQIAT FVASIAT FVASPLUSIA FoB2-Ts FOB2S-TS FOBS-TS FOBSS-TS FOB4TS FOBAUTS FOBASITS FOBSITS FOBSC-TS FOBSLITS FOBSSITS FOBSSUTS FOBSxL-TS FOBSSXL-TS IMinvmax pressure “114.0 )- 114.011 11450 lowed [bar g} vase | “Weou used 11401-41450 {Minimax design pressure 114.01 - Bera tas | ~WAOu-14.50 114.0 Mt 114559 [Max operating temperature [°C] 148 18210] 148. 15200 IMirvmax temperature 0182 1 flowed TC] rise) | orts2 1 ate4” ons2 asa” inmax design temperature cr onse [Sound pressure level Za (UNI EN ISO 3748) [4BA] [tenders supply voltage 400V / SOHz 3-phase L1/L2IL3/N/PE Installed power, ae basic version (kw) Installed power with steam fgenerator (Option KXt0) TK} i = 488 fax steam flemand Koh] ee e Peale 59 sumption of demineralized vater at 1 4 bars, with steam 10 26 erator (Option KX10) l/h] 60 compressed air 7 3f actuators [Nin] © [Compressed air ar counterpressure [Ni/min ] ‘%) 20 | 40) sa ee | 2m ie 700 ins water for fvacuur pump (Option 20) 110 10 | 130 | 150 vi] © 200 Jains water for fast cooling (Option Kxs2) (mm | °° 110 85 100 Heat dissipation 24°C in Keath 21008] aso sao | ssoazet” | asosaat |, 250) 100, (HT modes with Option KXGIAT (2) Oner optons: 400Vac 60H2, 440Vac 80H, 230Vac 50 He, 230Vac 60 He. {G) Adcltonal power required relative tothe basic version. As fo lites required forthe othor options, see the deserition of the option ‘elected. (8) Required i the steam generstor (Option KXt0) Is not instlies {@) Domand of oreo comprossed air a a pressure of 6 10 8 bars. (6) Max haraness 20°F at max temperature 32°C and min pressure 1.0 barg. FUSTOSTI ae March 2074FVA/A — FOB2-3-4.6 TS USE AND MAINTENANCE MANUAL z CAUTION If the steam generator (Option KX10) is installed, the necessary deionized water must have specific conductivity characteristics. Conductivity greatly differs according to the type of the plant producing deionized water and plant maintenance condition. Modern plants allow obtaining water with conductivity lower than & Siem, which is an optimum value for the application in question because low water conductivity allows minimizing descaling operations to the steam generator. Water with conductivit yS/cm can be used but, obviously, the generator would require be i frequently. We strongly recommend against using water with conduct conclusion, the necessary information can be summarized as follows +» Recommended conductivity: 2 to 15 yS/cm and the generator to be inspected once per year. «Permissible conductivity: up to 30 Siem and the generator to be inspected every 6 months. Incoming water should be purified and be subjected to a process of deionization or reverse = TOC< 500 ppb; © pH:6.0+7: ‘+ Chlorides: 30 ppm max H If the steam quality test is to be conducted, incoming water should also have the following characteristics: + Degassed at 80 to 85" ‘+ Kept flowing throughout the test. NOTE (CQ) The technical parameters and consumption data of the Bier test model are same as for model FOBSITS. NOTE LEO) Maximum prossure and temperature design values are shown in the PED documentation annexed to the technical documentation. FU a8 ene Wiarch 2014FVAIA -FOB2-3-4.5 TS USE AND MAINTENANCE MANUAL, 2 F) FEDEGARI 2.3 SAFETY SYSTEMS 2.3.1 Chamber Closing and Opening System (Series FOB4-5 TS) These sterilizers are equipped with one or two access doors to the sterilization chamber, with semi-automatic drive managed through the process controller. Chamber door opening and closing depend on @ number of hardware safety protections and software checks that ensure that the doors move only under absolutely safe conditions NOTE [LL] The door closing system does not pose a crushing risk for upper limbs. The vertical motion of the door being closed or opened takes place at reduced speed, The door closi 1g force is 15 kg max. The access door to the sterilization chamber slides vertically upwards when closing and downwards when ‘opening. The closing motion is driven by two gas (nitrogen) piston springs which are fastened to the door by means of a frame and make the door slide upwards gently and progressively. The presence of any obstacle ‘overcoming the force of the gas piston springs while the door is closing, causes the sliding motion to stop. This ‘motion will restart automatically once the obstacle is removed, At all times, the force necessary to oppose the spring action is such as to ensure that no damage is ever caused to persons or property. The opening motion is driven by @ pneumatic piston with a solenoid valve controlled by the electronics installed in the sterilizer. Air injection into the pneumatic piston at a pressure between 7 and 10 bars causes the retraction of the piston rod where the door bottom is connected by means of a steel tie-rod and pulleys. Piston rod retraction against the force of the two gas piston springs ensures opening of the door. In order to confirm that the door is correctly positioned, the sterilizer is equipped with two door status switches. One of them is mechanical and assembled to the outer top of the sterlization chamber; it is used to determine the door-closed status. The other is electromagnetic and assembled on top of the pneumatic piston; itis used to assess that the piston rod is fully retract and, consequently, the door is completely open. All components of the door drive system are appropriately protected and cased 23.2 Chamber Cover/Door Closing and Opening 2.3.2.1 Initial System Condition Series FVA/At Before chamber closure and as jong as the cover is reaching the closed position, the cover-closed limit switch remains open. This breaks the circuit thet allows compressed air into the sealing gasket seat, thus preventing the introduction of pressurized fluids into the chamber, as explained below. Series FOB2-3-TS and FOB4-5-TS Before chamber door closure and as long as the door is reaching the closed position, the door-closed limit switch remains open. This breaks the circuit that allows compressed air into the sealing gasket seat, thus preventing the introduction of pressurized fluids into the chamber, as explained below. MrUsaTeaTT Dn arenz014USE AND MAINTENANCE MANUAL * FW ~Fonza4s 7s (=| FEDEGARI 2.3.2.2 Starting the Closing Maneuver Series FVAIA1 ‘The cover is tuned manually from the open position to the closed position. To avoid crushing your fingers, tum the cover with your left hand while releasing the latch near the cover hinge with your right hand. ‘When the cover reaches the closed position, the limit switch status changes, thereby enabling the system to send the command signal that will allow manual injection of compressed air into the sealing gasket seat through the associated touch button. Series FOB2-3-TS ‘The door is turned manually on its hinge and brought to touch the edge of the sterilization chamber. Now, hold down and turn the closing handwheel on the door until the horizontal motion and rotation are complete. ‘When the door reaches the closed position, the handwheel springs back outwards and the limit switch status changes, thereby enabling the system to send the command signal that will allow manual injection of compressed air into the sealing gasket seat through the associated touch button. Series FOB4-5-TS Hold down the door-close deadman-type button = in the operator panel to cause the door to move upwards from the open position to the closed position. When the door reaches the closed position, the status of the door limit switch changes. Compressed air injection in the sealing gasket seat takes place automatically after e 2.3.2.3 Completing the Closing Maneuver Series FVAIA1 ‘Once obtained the authorization from the cover-closed limit switch, which confirms correct cover positioning, hold s ‘down the cover-lock deadman-type button in the operator panel to inject compressed air into the sealing gasket seat and achieve complete closure of the chamber with the cover locked. Series FOB2-3-TS Once obtained the authorization from the door-closed limit switch, which confirms correct door posit 384 down the door-lock deadman-type button in the operator panel to inject compressed air into the sealing gasket seat and achieve complete closure of the chamber with the door locked ing, hold Series FOB45-TS ‘Once obtained the authorization from the limit switch, which confirms correct door positioning, and after a delay + ofS”, the process controller commands the injection of compressed air into the sealing gasket seat and achieves ‘complete closure of the chamber with the door locked. 2.3.2.4 Sealing System Functioning Series FVAIA1 Pushed up by compressed air, the sealing gasket moves upwards and presses against the contour of the cover that is raised from the rest position and held in place by two semicircular brackets. MEU ETT Wr arch 2074FVII -F082.3-4.5 TS USE AND MAINTENANCE MANUAL, : FEDEGARI Series FOB2-3-TS Pushed up by compressed air, the sealing gasket moves towards the outside of its seat and presses against the Contour of the door, which is moved from the rest position and held in place by two semicircular brackets. Series FOB4-5-TS Pushed up by compressed air, the sealing gasket moves towards the outside of its seat and presses ageinst the contour of the door that moves from the rest position and is held in place by special closing brackets. The sealing gasket pressing against the coveridoor ensures complete closure of the autoclave and keeps it perfectly sealed against the action of any pressurized fluids introduced into the chamber. 2.3.2.5 Authorization to Introduce Fluid into the Chamber Air pressure in the sealing gasket seat is monitored by a pressure switch. When air pressure reaches the preset value, the pressure switch signals to the process controller that the chamber is closed and fully sealed, thus enabling the start of the processing cycle with fluid introduction into the chamber. The authorization to introduce fluids into the chamber given by the process controller is fail-safe by design as it includes a safety circuit checking that ‘+ The pressure switch indicates that the cover/door sealing gasket is inflated; and that ‘+The cover/door is in the correct position, as confirmed by the limit switch permission signal 2.3.2.6 Conditions Necessary to Start the Opening Maneuver To start opening the autoclave, all preliminary conditions specified below must be met and checked by the process controller, namely: '* The processing cycle has ended; ‘+ Both the pressure transducer connected to the autoclave control system and the electromechanical safety device signal that pressure inside the chamber has dropped back to atmospheric level, with a tolerance range of 40 mbars (adjustable); © The temperature probe TE1 placed in the chamber detects a temperature not higher than the value set by the operator from the control panel; ‘+ If Option KX84 is installed and the safety temperature feature is set, the PT100 probe (a dedicated TES probe placed in the chamber) shows a temperature not exceeding the value foreseen, which guarantees that any liquids put to sterlize into the autoclave in glass containers have reached a temperature lower than their boiling point at atmospheric pressure; ‘©The door on the side opposite maneuver side is closed (two-door models only) 2.3.2.7 Deflating the Sealing Gasket Seat Series FVAIA1 ‘Once obtained the above authorizations, press the cover-unlock fal button to discharge compressed air from the sealing gasket seat. Complete opening of the cover takes place after approximately 15 to 20 seconds due to the presence of the mechenical lock driven by @ pneumatic cylinder. Series FOB2-3-TS Once obtained the above authorizations, press the door-unlock button ma to discharge compressed air from the sealing gasket seat. Complete opening of the door takes place after approximately 1 to 20 seconds due to the presence of the mechanical lock driven by a pneumatic cylinder. Trusts wre March 2074USE AND MAINTENANCE MANUAL, 2 Fvaat -Fo824578 ©) FEDEGARI Series FOB4-5-TS ‘Once obtained the above authorizations, press the DOOR-OPEN button ial in the operator panel to discharge compressed air from the sealing gasket seat. 2.3.2.8 Opening the Chamber ‘Series FVAIA1 ‘After compressed air discharge from the sealing gasket seat and under correct temperature conditions, the ‘opening maneuver should be completed manually (Figure 2-6). Figure 2-6 - Chamber closing and opening Series FOB2-3-TS ‘After compressed air discharge from the sealing gasket seat, the opening maneuver should be completed ‘manually. To do this, press the hand wheel in the middle of the door and turn it clockwise, which will cause the door to move horizontally. Once the horizontal movernent is complete, release the hand wheel that springs back ‘outwards and open the door by rotating it on its hinge. Series FOB4-5-TS After compressed air discharge from the sealing gasket seat and with a 10° delay, the opening maneuver starts ‘automatically. The steriization chamber door moves downward until reaching the fully open position, which is reported to the process controller through the activation of a dedicated electromagnetic limit switch. MEU 863717 Bara March 2074