FVA/A1 STERILIZERS

FVA/A1 

SERIES 

STERILIZERS 

OPERATION AND MAINTENANCE MANUAL 

FEDEGARI AUTOKLAVEN AG 

� Via alla Gerra, 11 • CH-6930 Bedano - SWITZERLAND 

� 0041 91 9352090 • � 0041 91 9352099 • � http://www.fedegariautoklaven.ch

6. Process controller 

with integrated 

operator panel (Touch 

screen) 

7. Vacuum gauges for 

chamber and 

generator monitoring 

8. Emergency 

pushbutton 

9. Process printer 

10. Main switch 

11. Castors 

FVA/A1 - OPERATION AND 

MAINTENANCE MANUAL 

1. Sterilizer 

2. Technical area cabinet 

3. Manual discharge valve 

4. Safety lever of lid closure system 

5. Handle for opening sterilization 

chamber lid 

12. Load lifting device (hoist) 

13. Fastening accessory 

14. Product loading/unloading devices 

15. Chamber lid in fully open position 

! WARNING! 

FOR COMPLETE AND EXHAUSTIVE INFORMATION REGARDING THE 

OPERATION AND MAINTENANCE OF THIS MACHINE, 

PLEASE REFER TO THE TECHNICAL MANUAL 

July 2005 ID no. 85693 Rev. 2



CONTENTS 

1. INTRODUCTION ................................................................................................................................................... 4 

1.1. PURPOSE OF THIS DOCUMENT.................................................................................................................... 4 

1.1.1. DOCUMENT IDENTIFICATION ..........................................................................................................................................4 

1.2. DISCLAIMERS.................................................................................................................................................. 4 

1.3. CONFIDENTIALITY .......................................................................................................................................... 4 

1.4. ASSOCIATED DOCUMENTS ........................................................................................................................... 4 

1.5. USING THIS MANUAL...................................................................................................................................... 4 

1.6. MAINTAINING THE MANUAL........................................................................................................................... 4 

1.7. UPDATES ......................................................................................................................................................... 5 

1.8. ALARM SYMBOLS............................................................................................................................................ 5 

1.9. REFERENCES TO STANDARDS..................................................................................................................... 5 

2. SAFETY IN OPERATION ...................................................................................................................................... 6 

2.1. INTENDED USE................................................................................................................................................ 6 

2.2. PROHIBITED USE............................................................................................................................................ 6 

2.3. GENERAL POTENTIAL DANGERS.................................................................................................................. 7 

2.4. RISKS LINKED TO USE OF THE SOFTWARE................................................................................................ 8 

2.5. OPERATOR QUALIFICATION.......................................................................................................................... 8 

2.6. PERSONAL PROTECTION MEANS................................................................................................................. 9 

2.7. RECOMMENDATIONS AND PREVENTIVE STEPS TO BE TAKEN BY THE USER....................................... 9 

2.8. EMERGENCY SITUATIONS............................................................................................................................. 9 

2.8.1. BLACKOUT - ELECTRICAL SYSTEM ................................................................................................................................9 

2.8.2. FAILURE OF WATER SUPPLY ........................................................................................................................................10 

2.8.3. SHUTDOWN......................................................................................................................................................................10 

2.8.4. EMERGENCY STOP.........................................................................................................................................................10 

3. GENERAL DESCRIPTION OF THE MACHINE .................................................................................................. 11 

3.1. iNTRODUCTION............................................................................................................................................. 11 

3.2. RANGE IDENTIFICATION .............................................................................................................................. 11 

3.3. MACHINE IDENTIFICATION .......................................................................................................................... 11 

3.4. KEY COMPONENTS OF THE MACHINE....................................................................................................... 12 

3.5. MAIN ADDITIONAL (OPTIONAL) COMPONENTS OF THE MACHINE ......................................................... 12 

3.6. CONTROL AND MONITORING DEVICES ..................................................................................................... 12 

July 2005 1 / 31 ID no. 85693 Rev. 2



3.6.1. CONTROL AND MONITORING STATIONS .................................................................................................................... 13 

3.7. SAFETY SYSTEMS ........................................................................................................................................ 13 

3.7.1. DESCRIPTION OF THE CHAMBER CLOSING AND OPENING SYSTEM ..................................................................... 13 

3.7.2. SAFETY VALVES ............................................................................................................................................................. 14 

3.8. TECHNICAL DATA ......................................................................................................................................... 14 

3.8.1. MAIN DIMENSIONS AND WEIGHTS............................................................................................................................... 14 

3.8.2. TECHNICAL PARAMETERS............................................................................................................................................ 14 

3.8.3. WATER/AIR CONSUMPTION .......................................................................................................................................... 15 

3.8.4. EMC SPECIFICATIONS ................................................................................................................................................... 15 

4. TRANSPORT, HANDLING AND STORAGE ...................................................................................................... 16 

4.1. TRANSPORT.................................................................................................................................................. 16 

4.2. HANDLING...................................................................................................................................................... 16 

4.3. STORAGE....................................................................................................................................................... 16 

5. INSTALLATION................................................................................................................................................... 17 

5.1. ACCEPTABLE ENVIRONMENTAL CONDITIONS FOR OPERATION........................................................... 17 

5.2. REMOVING PROTECTIVE MATERIALS ....................................................................................................... 17 

5.3. MACHINE PLACEMENT................................................................................................................................. 17 

5.4. CONNECTION TO POWER SOURCES AND UTILITIES............................................................................... 17 

5.4.1. HYDRAULIC CONNECTIONS.......................................................................................................................................... 18 

5.4.2. CONNECTIONS TO THE ELECTRIC POWER SUPPLY................................................................................................. 18 

5.5. CHECKING THE INSTALLATION................................................................................................................... 18 

6. USE ..................................................................................................................................................................... 19 

6.1. GENERAL DESCRIPTION OF OPERATION.................................................................................................. 19 

6.2. SOFTWARE STRUCTURE............................................................................................................................. 19 

6.3. ACCESS LEVELS........................................................................................................................................... 20 

6.4. OPERATING PHASES ................................................................................................................................... 20 

6.4.1. INITIAL TESTS ................................................................................................................................................................. 20 

6.4.2. POWER-ON...................................................................................................................................................................... 21 

6.4.3. PRODUCT LOADING ....................................................................................................................................................... 22 

6.4.4. PROGRAM START AND RUN ......................................................................................................................................... 24 

6.4.5. PRODUCT UNLOADING.................................................................................................................................................. 24 

6.4.6. SHUTDOWN..................................................................................................................................................................... 25 

6.5. “PHASE STEP” AND “CYCLE STOP” FUNCTIONS....................................................................................... 25 

6.6. ALARM MESSAGES...................................................................................................................................... 26 

6.7. EMERGENCY PHASE.................................................................................................................................... 26 

ID no. 85693 Rev. 2 2 / 31 July 2005



6.8. AUXILIARY FUNCTIONS................................................................................................................................ 26 

7. ALARMS AND TROUBLESHOOTING................................................................................................................ 27 

7.1. ALARMS ......................................................................................................................................................... 27 

8. ORDINARY MAINTENANCE .............................................................................................................................. 28 

8.1. PREVENTIVE MAINTENANCE PROCEDURES ............................................................................................ 28 

8.1.1. VISUAL INSPECTION.......................................................................................................................................................28 

8.1.2. CLEANING ........................................................................................................................................................................28 

8.1.3. PERIODIC EFFICIENCY CHECKS...................................................................................................................................29 

8.2. CORRECTIVE MAINTENANCE PROCEDURES............................................................................................ 29 

8.2.1. REMOVING JAMS.............................................................................................................................................................29 

9. REMOVAL FROM SERVICE............................................................................................................................... 30 

10. TECHNICAL SUPPORT ...................................................................................................................................... 31 

July 2005 3 / 31 ID no. 85693 Rev. 2

1. INTRODUCTION 



1.1. PURPOSE OF THIS DOCUMENT 

This manual is intended for users of sterilizers of the FVA/A1 range. It contains all the information required for proper use of these 

machines. Strict and sensible compliance with the instructions and rules given in this manual is essential for the proper operation and 

durability of each machine and for safeguarding and protecting the safety of the operator and of the materials being processed. 

Accordingly, you should read carefully all the prescriptions given in this manual and follow them strictly. All the information given here 

is up-to-date as of the publication date. 

1.1.1. DOCUMENT IDENTIFICATION 

This “OPERATION AND MAINTENANCE MANUAL” is an official document issued by FEDEGARI AUTOKLAVEN AG (hereafter 

referenced as FEDEGARI for the sake of brevity) and is an integral part of the machine. It is identified by a Document Code given in 

the footer of each page, allowing its identification, traceability and subsequent reference. 

1.2. DISCLAIMERS 

FEDEGARI has made every effort to ensure that the information contained in this manual is accurate and exhaustive. However, it 

assumes no responsibility in case of errors or omissions. FEDEGARI reserves itself the right to amend, at any time and without 

notice, the specifications of the hardware and software described in this document. FEDEGARI reserves itself the option of amending 

this manual at any time without notice. 

1.3. CONFIDENTIALITY 

Full or partial duplication, transmission, transcription or storage in an information retrieval system, and translation into other 

languages, in any form, of this manual and of the associated documents are strictly prohibited without the prior written permission of 

FEDEGARI. 

1.4. ASSOCIATED DOCUMENTS 

Further information on this sterilizer is available in the following document: 

� TECHNICAL MANUAL 

1.5. USING THIS MANUAL 

This manual must be read sequentially, i.e., from beginning to end, one page after the other, and the various notices and WARNING!s 

must be understood and remembered. 

Since it is assumed that the operator is qualified to use this type of machine, all general information and instructions that necessarily 

must be part of his background knowledge have been omitted. 

This manual must be considered as an integral part of the machine and must therefore follow it in all its transfers, both within and 

outside the company in which it is used. 

1.6. MAINTAINING THE MANUAL 

This manual must be preserved throughout the life of the machine. Store this manual in places that are protected against humidity 

and heat. Do not remove, tear or rewrite parts of this manual for any reason. 

If operating situations that are not considered by, or do not match, the ones presented in this manual occur, contact the manufacturer 

immediately for a possible update. 

You must ensure that all the updates you receive promptly replace the corresponding obsolete documents. 

This manual must be stored with the greatest possible care. Avoid inappropriate handling and any damage, however partial, to its 

contents. 

The operator is responsible for replacing the manual immediately if it is damaged, lost or rendered fully or partially unintelligible. 

ID no. 85693 Rev. 2 4 / 31 July 2005



1.7. UPDATES 

Any updates to this document will be sent to the owner of the machine in electronic format together with suitable instructions for 

viewing them. 

If the machine is to change owner, the current owner should report to FEDEGARI the appropriate information in order to allow any 

updates to be sent to the new owner. 

1.8. ALARM SYMBOLS 

In this manual, the following symbols inform the user of the availability of additional information not contained in the text, of 

particularly important information, and of particularly delicate and dangerous procedures. 

� NOTE 

This symbol indicates important information highlighted separately from the text. 

; CAUTION 

This symbol indicates a condition in which negligence or incorrectly performed procedures can cause possibly 

irreparable damage to the sterilizer. 

! WARNING! 

This symbol is used to indicate a situation that entails danger to people. 

For certain specific risks, these generic symbols are complemented by particular symbols that are explained in each instance in the 

text. 

These additional symbols match the ones provided on the machine by means of plates and/or stickers to indicate dangerous areas 

and behaviors. 

Before approaching the machine and starting any operation, whether for normal use or for maintenance, you must read carefully 

these signs, messages and instructions and understand their meaning. 

The operator is responsible for immediately replacing any plates, stickers, panels etc. applied to the machine that have been lost or 

damaged or have become partly or fully unintelligible. 

1.9. REFERENCES TO STANDARDS 

The contents of this document comply with the requirements of the following standards: 

- UNI EN 292/2 - 1992 ISO 292/2; 

- EN 61010-1 - 2001 IEC 1010-1; 

- EN 61010-2-041 - 1997 IEC 1010-2-041; 

and with the following European Directives: 

MD 98/37/EC (Machinery Directive); 

LVD 73/23/EC (Electrical Safety) and subsequent amendments thereof; 

PED 97/23/EC (Pressure Equipment); 

MDD 93/42/EC (Medical devices 1 ); 

EMC 89/336/EC (Electromagnetic Compatibility) and subsequent amendments thereof. 

1 Sterilizers used to treat medical devices before reuse must comply with directive 93/42/EC and with the EN285 standard. To meet 

fully these requirements, the Independent data logging option and the Vacuum pump option must be included in the supply; 

furthermore, the installation tests must be performed as required by the EN 285 standard. 

July 2005 5 / 31 ID no. 85693 Rev. 2

2. SAFETY IN OPERATION 

2.1. INTENDED USE 

! WARNING! 



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



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

Symbol/Description of plate Plate location 

; CAUTION 

It is absolutely indispensable to ensure the following: 

1. Main switch 

2. Manual valve for discharging chamber pressure 

1. Inside the technical area panel 

2. Rear of electrical panel 

1. Chamber body 

2. Steam generator 

1. Electrical panel 



the stability of the power supply voltage intended for the sterilizer must be within a tolerance equal to ± 10% of the 

required nominal value (frequency ± 2%); 

failure to comply with this recommendation may cause severe malfunctions during sterilization cycles and damage 

to the machine; 

while cleaning or washing the chamber or parts of the sterilizer, absolutely do not use alcohol, gasoline, solvents of 

any kind or substances that have an acid reaction, which can damage the stainless steel surfaces and the elastomer 

parts; 

use water, optionally in a weak solution with neutral detergents, in the manner described in the maintenance 

instructions given in this manual; 

in any kind of process, and particularly during manual interventions, FEDEGARI guarantees the sterilization 

processes of its machines only when the person in charge of the process has given clearance of correct execution of 

all the phases of the cycle provided for the product, by placing an approval signature on the document printed by the 

control system of the autoclave. 

2.4. RISKS LINKED TO USE OF THE SOFTWARE 

Use of the software provided by FEDEGARI together with its products is granted under license and occurs under the full responsibility 

of the customer (see also the General Terms of Sale). 

! WARNING! 

FEDEGARI or its representatives cannot in any circumstance be deemed responsible for direct or indirect damage 

arising from the use of the software, from any defects present in the software, or otherwise arising from the users’ 

license of the software. 

2.5. OPERATOR QUALIFICATION 

The operations described in this manual and related to the individual phases of the life cycle of the machine have been analyzed 

carefully and exhaustively by FEDEGARI also in accordance with the characteristics of the operator. 

Operator competence is a necessary and indispensable condition to allow correct use of the machine in compliance with all the safety 

requirements of this manual. 

ID no. 85693 Rev. 2 8 / 31 July 2005



2.6. PERSONAL PROTECTION MEANS 

The assigned operator, in accordance with the nature of the loads to be treated, must be able to protect his body by using adequate 

protective means. 

! WARNING! 

Before taking charge of the load, the operator must ALWAYS be able to check and ascertain the nature of the 

materials that constitute it. 

The assigned operator must work with clothing that offers adequate protection against the potential risks caused by 

contact with the most disparate materials. 

It is the responsibility of the buyer to ensure, in compliance with the standards applicable in the country where the 

machine is used, that the means used have the highest degree of protection in relation to the type of product to be 

processed. 

The protective means to be adopted must allow sufficient freedom of motion to perform the intended manoeuvers. 

As regards visual perception, such means must preserve the broadest angle with the lowest distortion. 

Use only certified and approved protective means. The protective means must be used and maintained correctly 

(e.g., worn correctly, fastenings closed appropriately, mask filters replaced, et cetera). 

; CAUTION 

Personal protection means are expressly recommended for certain cases in order to protect the processed product, 

so as to avoid its contamination (typically during unloading operations). 

In any case, when dealing with products that entail no chemical or microbiological risk, it is advisable: 

- to wear an impermeable cotton overall or other clothing that allows good breathability but does not leave any part of the body 

exposed except for the face; 

- to wear shoes that offer an adequate degree of comfort as well as suitable mechanical protection and good insulation against any 

spillage of liquids; 

- to wear spray protection goggles that have a lightweight structure, are not made of glass or splintering materials, and are 

transparent, with the best refractive index, the best visual angle and the lowest degree of distortion. 

2.7. RECOMMENDATIONS AND PREVENTIVE STEPS TO BE TAKEN BY THE USER 

It is the user’s responsibility to provide the installation area with lighting systems that are suitable and approved by applicable 

workplace health and safety standards. 

The user must ensure that the work area in front of the sterilizer has non-slip flooring. This flooring must be made of inert or polymeric 

materials that are easily washable and resistant to chemical and thermal disinfection treatments. The flooring must be resistant to any 

intended sanitization treatments in accordance with the products to be sterilized. 

Clear and legible graphic signs forbidding access of unauthorized personnel to the work area must be placed conspicuously in the 

vicinity of the work area. 

Before tasks are assigned, the user must train the assigned operators appropriately and ensure that they have acquired the 

necessary knowledge and manual skills according to the required profile of professional characteristics. 

It is the user’s responsibility to provide the machine installation area with suitable firefighting stations. The operator must be able to 

access, in case of emergency, the main switch and the flow control valves of the primary supplies. 

! WARNING! 

Firefighting means of the CO2 type are recommended for fire prevention. 

2.8. EMERGENCY SITUATIONS 

The machine must always be safe, even during abnormal conditions and after such conditions cease. 

2.8.1. BLACKOUT - ELECTRICAL SYSTEM 

If an electrical “blackout” occurs, the sterilizer shuts down. 

If the sterilizer was in a phase of an operating cycle: 

July 2005 9 / 31 ID no. 85693 Rev. 2



When electric power returns, an acoustic alarm is issued and the operator must recognize the emergency state by acting 

on the mute icon of the touch-screen; 

The operator must then leave the emergency state by acting on the STOP icon of the touch-screen; 

The sterilizer is thus brought to the atmospheric pressure balancing phase. 

If the sterilizer was not in a phase of an operating cycle: 

when electric power returns, the Fedegari logo is displayed while waiting for commands from the operator. 

The sterilization chamber is provided with a pneumatic gasket for sealing the lid and with associated devices for ensuring the 

tightness of the chamber even if there is no electric or pneumatic power. 

In particular, depressurization of the pneumatic gasket of the door takes longer than the depressurization of the chamber. 

Atmospheric pressure in the chamber, caused by failure of the tightness of the gasket as a consequence of a blackout, is reached 

after at least 20 hours, depending on the overall maintenance level of the machine. 

2.8.2. FAILURE OF WATER SUPPLY 

In order to ensure that the steam generator is supplied with pressurized water at 1 to 4 bars, the sterilizer is provided with a selfpriming 

pump, which is capable of drawing water from any container located outside the sterilizer or from the water supply mains. 

In order to protect its integrity, the self-priming pump is equipped with a suitable internal device for checking the minimum level of the 

liquid. 

Any interruption in the water supply of the steam generator increases the time required to complete the process phases in progress. If 

the water supply fails, the sterilizer issues an acoustic alarm signal and is then forced by the operator into a state known as 

“emergency” and waits for the optimum parameters to be stored. 

� NOTE 

If the optional Vacuum and drying assembly kit or the Quick drying assembly kit is installed, the sterilizer is 

equipped with a vacuum pump and/or with an internal cooling plate. 

Interruption of the water supply of the vacuum pump and/or of the internal cooling plate increases the time required 

to complete the phases of the process in progress. In this case, it is possible to force the sterilizer into a state 

known as “emergency” while waiting for the optimum parameters to be restored. 

2.8.3. SHUTDOWN 

The machine is equipped with a main circuit breaker, which is located on the rear panel. Opening this circuit breaker completely stops 

the supply of electric power to the machine. 

The main circuit breaker disconnects all the poles of the power supply line. 

2.8.4. EMERGENCY STOP 

The machine is provided with an emergency switch, which is located in the lower part of the post of the process controller. Activation 

of the mushroom-type emergency pushbutton, provided with a mechanical reset, disconnects the electric power supply of the 

sterilizer. 

If the sterilizer was in an operating cycle phase: 

When electric power returns, an acoustic alarm signal is issued and the operator must acknowledge the state of 

emergency by acting on the mute icon of the touch-screen; 

Tthe operator must then leave the state of emergency by acting on the STOP icon of the touch-screen. The sterilizer is 

thus brought to the atmospheric pressure balancing phase. 

If the sterilizer was not in an operating cycle phase: 

when electric power returns, the Fedegari logo is displayed while waiting for commands on the part of the operator. 

ID no. 85693 Rev. 2 10 / 31 July 2005



3. GENERAL DESCRIPTION OF THE MACHINE 

3.1. INTRODUCTION 

In the early 1990s, FEDEGARI introduced to the market the first compact top-loading saturated-steam sterilizers of the FVA/A1 

series. 

Although designed as a product for assembly-line production, their original design was an efficient solution for every type of 

application: they were conceived as modular machines that could be configured, adapting them to the specific requirements of the 

customer without however working beyond the limitations of the machine. 

The new version of the FVA/A1 series has a wide range of solutions that retain the originality and innovation established by acquired 

experience. 

The broad range of options of the modular system allows to set configurations of the machine that are built according to the 

requirements of the Customer and are capable of adapting to various applications and to the treatment of a considerable variety of 

loads, including waste with high pathogen risk, in addition to solids and liquids, in both open and sealed containers. 

The FVA/A1 models are the latest generation of small automatic saturated-steam sterilizers for microbiology laboratories, research 

institutes, universities, food and pharmaceutical industries, hospitals and other applications in the medical field. 

The new particularly appealing style, the revised and improved design and the internal organization of the components ensure 

improved ergonomics and easy access for maintenance. The process controller allows simple and extremely intuitive communication, 

requiring no specific information technology skills, since the man-machine interface is provided by means of a graphic panel of the 

touch-screen type. 

The software is completely validated, so that it can be used by the most demanding users. 

3.2. RANGE IDENTIFICATION 

The FVA/A1 sterilizer range is composed of the following models, which differ in terms of useful loading capacity: 

� FVA2/A1 – 75 l 

� FVA3/A1 – 140 l 

The main features of this line of sterilizers are: 

• safety and functional simplicity; 

• high performance and flexible processes; 

• automated operation; 

• easy transport e and installation; 

• compact and ergonomic design. 

3.3. MACHINE IDENTIFICATION 

Steam sterilizers of the FVA/A1 range are identified by means of a suitable plate, which is permanently affixed to the body of the 

autoclave. This plate bears all the key data of the autoclave. The markings on the plate are indelible, as prescribed by product 

standards. 

Figure 3.3 shows a facsimile of the CE identification plate of the machine. 

July 2005 11 / 31 ID no. 85693 Rev. 2

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. 



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



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



- if the optional function (safety temperature) is set, the heat probe arranged in the chamber must detect a temperature that does 

not exceed the set value, making sure that any liquids placed to be sterilized in glass containers inside the autoclave have 

reached a temperature that is lower than their boiling point at atmospheric pressure; 

- once the process controller has enabled lid opening, the air introduced in the gasket can be released if the residual pressure in 

the chamber has been checked to be lower than 50 mbar by means of a pressure-controlled switch. This check is performed with 

fail-safe criteria. 

Release of the air fed into the gasket seat 

Once the clearances listed in the preceding subsection have been obtained, if the operator presses the door release button, the 

compressed air is discharged from the gasket seat. 

Manual opening of the autoclave 

After automatic discharge of the air from the sealing gasket seat, the opening maneuver is completed manually. 

3.7.2. SAFETY VALVES 

To ensure total safety of the operator, the sterilizer is equipped with the following devices: 

� a safety valve that discharges the excess pressure inside the chamber; 

� a safety valve that discharges the excess pressure in the autonomous steam generator. 

� NOTE 

Please refer to the technical manual of the machine for a detailed description of the functions and checks to be 

performed on the safety valves. 

3.8. TECHNICAL DATA 

3.8.1. MAIN DIMENSIONS AND WEIGHTS 

The main dimensions of the vertical steam sterilizer related to the FVA/A1 range are listed in the following table: 

Model 

Main data of the various models 

FVA2/A1 FVA3/A1 

Useful loading capacity [l] 75 140 

Chamber type vertical with cylindrical cross-section, top-loading 

Chamber diameter [mm] 400 500 

Useful height [mm] 600 700 

Weight when empty [kg] 150 175 

Weight when filled with water [kg] 270 340 

Loading height [mm] 875 875 

External dimensions (1) W x H x D [mm] 1200 × 1305 × 600 1200 × 1305 × 600 

Notes to the table: 

(1) External dimensions measured when the lid is closed. 

3.8.2. TECHNICAL PARAMETERS 

� NOTE 

Please refer to the technical manual of the machine for a detailed description of the functional, electrical and 

construction parameters. 

ID no. 85693 Rev. 2 14 / 31 July 2005



3.8.3. WATER/AIR CONSUMPTION 

� NOTE 

Please refer to the technical manual of the machine for a detailed description of air and water consumption. 

3.8.4. EMC SPECIFICATIONS 

� NOTE 

Please refer to the technical manual of the machine for a detailed description of the EMC specifications. 

July 2005 15 / 31 ID no. 85693 Rev. 2

4. TRANSPORT, HANDLING AND STORAGE 



4.1. TRANSPORT 

If the sterilizer is to be transported outside the destination areas, it is recommended to follow the procedures for the loading and 

unloading operations described in the technical manual of the machine. 

! WARNING! 

Improper use of the lifting or anchoring devices of the machine can cause severe damage to the machine and to its 

operators. 

4.2. HANDLING 

All FVA/A1 models are provided with a suitable stand on a set of four wheels, which ensures easy handling both during installation 

and during maintenance or emergency. 

Final placement of the machine at the installation site is generally performed by two operators. 

To ensure correct and safe handling of the machine, it is recommended to perform the following steps: 

1. remove the enclosure that protects the machine, separating it from the platform that constitutes the base of the package; 

2. transport the machine, keeping it fixed to the base of the package, to the installation site, and then deposit it on the floor of the 

room; 

3. remove the locking devices; 

4. lift the machine, freeing it from the pallet. 

! WARNING! 

If the handling of the machine requires lifting, check that the cables and the lifting means are suitable for the 

required capacities and have the approvals required by the relevant local laws. 

4.3. STORAGE 

The machine can be stored in a closed dry room with a temperature comprised between 4°C and 50°C and a relative humidity of no 

more than 80%. 

If rooms suitable to ensure these environmental conditions for machine storage are not available, it is advisable to ask FEDEGARI to 

supply the machine with a heat-sealed enclosure made of multi-ply barrier material in a sea case. 

! WARNING!! 

Sunlight can cause severe damage to the plastic and rubber parts. Direct exposure to the sun for prolonged periods 

must be avoided. 

; CAUTION 

Storage periods of less than two months are recommended. If longer periods are necessary, the gaskets should be 

treated with silicone oil in order to prevent early deterioration or unwanted sticking. After particularly long storage 

periods, it may be necessary to replace gaskets and seals before returning the machine to production status. 

ID no. 85693 Rev. 2 16 / 31 July 2005



5. INSTALLATION 

5.1. ACCEPTABLE ENVIRONMENTAL CONDITIONS FOR OPERATION 

The installation room must be ventilated and adequately lit. The following environmental conditions are suitable for correct operation 

of the machine and of its management system. 

Environmental parameters 

Machine for use indoors 

Maximum altitude 2000 meters 

Operating ambient temperature 10°C minimum - 40°C maximum 

Operating relative humidity maximum 85% noncondensing, with T ≤ 40°C 

Storage ambient temperature 4° C minimum - 50° C maximum 

Storage relative humidity maximum 80%, with T ≤ 40°C 

Maximum mains voltage variation +/- 10% of nominal voltage, +/- 2% frequency 

Installation category II 

Degree of pollution 2 

5.2. REMOVING PROTECTIVE MATERIALS 

The machine is transported in suitable containers (packages), wrapped in materials that are meant to protect it against external 

agents during transport and storage. The packaging materials must be removed with utmost care, in order to prevent improper 

interaction with the structures and the surfaces of the machine during these operations. The external cabinet of the machine is 

painted and therefore it requires suitable care to keep it free from scratches and scuffing. 

� NOTE 

It is recommended to keep the original packaging container in order to ensure correct transport of the machine in 

case of transfers. 

5.3. MACHINE PLACEMENT 

Correct placement of the machine ensures perfect functionality of the system and easy use by the operator. 

For placement, consider that the space available around the machine must be provided so as to ensure that the operator and the 

maintenance personnel can perform the following activities: 

� the movements required to work easily with the monitoring and actuation devices; 

� all the movements required for loading/unloading operations, including use of any accessories provided; 

� ordinary maintenance, particularly for cleaning and sanitization; 

� extraordinary maintenance. 

After placing the machine, it is recommended to check its perfect leveling. 

The sterilizer must be placed on a flat surface and in the vicinity of an extractor hood. 

Place the machine by following strictly the above prescriptions and the details shown in the installation drawings and documents 

supplied by FEDEGARI. 

5.4. CONNECTION TO POWER SOURCES AND UTILITIES 

Connection to power sources must be performed in full compliance with the specifications given by the manufacturer. If you do not 

have the suitable means or accessories that allow connection according to best practices, contact FEDEGARI’s technical service. 

July 2005 17 / 31 ID no. 85693 Rev. 2

5.4.1. HYDRAULIC CONNECTIONS 

� NOTE 



Please refer to the technical manual of the machine for a detailed description of the hydraulic connections. 

5.4.2. CONNECTIONS TO THE ELECTRIC POWER SUPPLY 

Connection of the power supply cable of the machine to the electrical mains is under the responsibility and care of the customer. 

When performing the connection, strict compliance with the following is recommended: 

! WARNING! 

Connection to the electrical mains must be performed exclusively by qualified personnel, fully complying with all the 

safety requirements prescribed by applicable standards with reference to the installation site of the machine. 

All connections must be made with no mains voltage present. 

! WARNING!! 

Please refer to the technical manual of the machine in order to determine the correct polarities and connection 

sequence. 

Connecting the ground conductor poorly, or not connecting it at all, may seriously compromise the operating safety 

of the sterilizer. FEDEGARI declines any responsibility arising from connecting the ground conductor poorly or not 

at all. 

� NOTE 

Please refer to the technical manual of the machine for a detailed description of the electrical connections. 

5.5. CHECKING THE INSTALLATION 

Before normal use of the sterilizer, it is necessary to provide a short running-in period, which consists in performing at least two 

complete cycles while the machine is empty. 

During this period, it is necessary to monitor and search for any anomalies. 

The machine can be introduced in the normal production cycle only after these tests have been successful. 

If anomalies in operation are observed, contact the manufacturer immediately. 

� NOTE 

Please refer to the technical manual of the machine for further information on the installation of the sterilizer. 

ID no. 85693 Rev. 2 18 / 31 July 2005



6. USE 

6.1. GENERAL DESCRIPTION OF OPERATION 

All the main functions of the sterilizer are controlled by a process controller, which is composed of a PLC with integrated touchscreen. 

Its management depends on resident software, which is structured according to menus and submenus, which can be 

accessed only by entering suitable passwords. The access levels allowed permit to enter the menus of the software according to a 

preset hierarchy. 

The operator interacts with the machine by means of the touch-screen and manages the sterilization process according to preset 

programs, which can be customized according to the specific parameters. 

The set of main activities involved in treating the processed materials in order to sterilize them is termed sterilization process, or, 

more commonly, sterilization cycle or cycle. 

On the sterilizer, execution of a cycle leads to the evolution of a specific program on the process controller. 

The process controller, by means of its own operating system and of the program mentioned above, coordinates a series of actions 

aimed at the components and elements that control the fluids at the various temperatures and pressures. 

This provides the most correct and appropriate transfer of heat energy to the load according to its physical characteristics. 

The following main activities can be distinguished in the sterilization process: 

- autoclave preparation; 

- load sterilization; 

- cycle end. 

Each of these main activities is composed of further operating processes, simply termed phases, which vary, according to the 

programs selected from the menu by the operator, in terms of the values of the physical parameters that characterize the liquids/fluids 

involved in the process. 

These main activities typically comprise the following operating phases. 

� Autoclave preparation 

� Initial tests 

� Power-on 

� Product loading 

� Load sterilization 

� Program start and execution 

� Cycle end 

� Product unloading 

� Shutdown 

� NOTE 

Please refer to the OPERATING PHASES subsection for full details of the individual phases. 

6.2. SOFTWARE STRUCTURE 

The software that is resident in the process controller is composed of two fundamental parts, which are known as: 

• PLC SOFTWARE 

• PANEL SOFTWARE 

� NOTE 

Operator access to the PLC software is not allowed. 

The operator can access the panel software only at specific access levels, which are enabled by entering 

appropriate passwords. 

Please refer to the technical manual for the characteristics and structures of the panel software. 

July 2005 19 / 31 ID no. 85693 Rev. 2



6.3. ACCESS LEVELS 

To protect the system and ensure a hierarchy according to reasonably identifiable skills, access is allowed only according to different 

authorization levels by first entering a code known as password. 

� NOTE 

The sterilizer is supplied with the following default password: 

− Level 4 User Supervisor 2222 Enables machine operation and parameter changing 

Moreover, the user supervisor can enable the following lower levels: 

− Level 5 User Operator 1111 Enables machine operation 

− Level 6 Stand-by 0000 Stand-by 

� NOTE 

Please refer to the technical manual of the machine for further details of the access passwords and of the operating 

functions associated with them. 

6.4. OPERATING PHASES 

Operator management of the generic sterilization process is organized according to the following operating phases: 

� initial tests; 

� power-on; 

� product loading; 

� program start and execution; 

� program unloading; 

� shutdown. 

6.4.1. INITIAL TESTS 

Check that the machine is connected to the electric 

power supply line. 

Check that the discharge of the machine is connected 

correctly to a conveyance system that is suitable to work 

at temperatures close to 100°C. 

Figure 6.4.1.A 

Figure 6.4.1.B 

ID no. 85693 Rev. 2 20 / 31 July 2005



Check that the manual valve for discharging chamber 

pressure is closed. 

Check the connection of the various utilities (water, 

compressed air, electric power, etc.) to the sterilizer. 

6.4.2. POWER-ON 

Check that the emergency pushbutton is deactivated. 

Supply power to the machine by turning the main 

switch clockwise (from the OFF position to the ON 

position). 

The machine performs automatically a short initial test. 

At the end of the initial test, the touch-screen displays 

the FEDEGARI logo; by pressing any point on the 

touch-screen, the operator can access the main menu. 

Figure 6.4.1.C 

Figure 6.4.1.D 

Figure 6.4.2.A 

Figure 6.4.2.B 

� From the main menu, the operator activates the operation of the steam generator by touching the DGE 

ON icon on the touch-screen. This operation is recommended in order to reduce the waiting times 

between the selection of the sterilization program and the start of the program. 

� NOTE 

The “door open” condition is independent of the actual position of the lid of the sterilization chamber, as it indicates 

the lack of pressure (inflation) of the lid sealing gasket. 

July 2005 21 / 31 ID no. 85693 Rev. 2

6.4.3. PRODUCT LOADING 

� Open the lid of the chamber by turning it counterclockwise; 

� Remove the temperature monitoring sensor from the sterilization chamber 

� Use the appropriately provided devices and accessories to load the product to be sterilized 

� Place the Pt100 flexible temperature control sensor and any optional component listed below: 

� optional heat probe; 

� safety thermal block device. 

in the upper drum so that their metal tips are in contact with the product. 

� NOTE 

During product loading, pay particular attention to avoid damaging the heat probes. 



In order to facilitate the loading of the product to be sterilized, it is recommended to use the appropriately provided drums for 

positioning the load. These drums are made of AISI 304 stainless steel, are provided with a handle to allow easier transport or 

coupling to the optional electric winch, and have a stainless steel supporting plate. The structure is a perforated mesh, which is meant 

to avoid retaining condensed water at the end of the sterilization process. The shape of the drum is designed in order to contain the 

various loads to be sterilized that are normally used in laboratories. 

Figure 6.4.3.a- Loading operation Figure 6.4.3.b- Loading devices 

� NOTE 

For further information regarding the various available drum models of drum, please refer to Section 1 of the 

TECHNICAL MANUAL. 

! CAUTION! 

During product loading operations, check that the load is arranged evenly inside the drum in order to avoid 

imbalances during lifting. 

If the final weight of the drums makes them difficult to handle due to the loading of the product in the drums, it is advisable to use the 

appropriately provided load lifting device, which can be supplied as an optional kit. 

IThe load lifting device falls within the scope of workplace safety standards and is constituted by an electrically-driven winch (Fig. 

6.4.3.c) and by the associated coupling accessory (Fig. 6.4.3.d). The horizontal movement of the oscillating arm of the winch is 

manual, while the vertical movement is provided by an electric motor. For safety reasons, the movement of the arm of the winch is 

interrupted when the control pushbutton is released. The winch structure and the arm are made of AISI 304 stainless steel. 

ID no. 85693 Rev. 2 22 / 31 July 2005



Fig. 6.4.3.c – Lifting device Fig. 6.4.3.d – Coupling accessory 

! CAUTION! 

Fig. 6.4.3.e - Correct placement of coupling 

accessory 

Improper use of the load lifting device may endanger the operator. 

The lifting device should not be used at all to handle loads with accessories other than those specifically provided by 

FEDEGARI. 

! CAUTION! 

In order to ensure safe and balanced lifting of the material containment drums, it is recommended to use only the 

appropriately provided coupling accessory. 

Pay particular attention to the placement of the coupling accessory in order to ensure correct grip on the central part 

of the handle of the drum. 

Poor distribution of the load inside the drum and/or poor placement of the coupling accessory may cause the load to 

tip during drum lifting, with consequent danger for the operator. 

! CAUTION! 

Pay particular attention during the insertion of the load containment drum in the sterilization chamber in order to 

avoid crushing the hands of the operator between the upper rim of the chamber and the drum. 

! CAUTION! 

All the recommendations given above regarding the use of the load lifting hoist and of its accessories, to the extent 

to which they are applicable, must be followed also during product unloading. 

! CAUTION! 

If the product is composed of containers having different dimensions, arrange the heat probe in the largest 

container. 

To sterilize thermolabile products, all the containers should be of the same size. 

If the product to be sterilized is a liquid solution contained in hermetically closed bottles, the heat probe must be 

placed inside a reference bottle filled with demineralized water. 

The reference bottle, placed inside the chamber in the upper drum, must be prepared so as to accurately reproduce 

the characteristics of the load. 

Ensure that the cable(s) of the temperature monitoring sensor is(are) inserted in the chamber before closing the lid. 

July 2005 23 / 31 ID no. 85693 Rev. 2

Close the lid of the sterilization chamber by turning it 

clockwise and lifting the safety lever. 



Figure 6.4.3.f 

� Lock the lid of the chamber by inflating the safety gasket, by pressing the dedicated icon of the touchscreen. 

The message CLOSED is displayed on the touch-screen. 

6.4.4. PROGRAM START AND RUN 

� Enable selection of the sterilization program by pressing the dedicated icon on the touch-screen of the 

operator panel. The touch-screen displays the list of available programs (up to 10) (5 programs per page, 

page changing selectable by means of the arrow key); 

� select the chosen program by pressing the dedicated icon of the touch-screen (icons 1 to 10); 

� a screen for customizing the selected program is displayed, allowing to add notes referred to the process or 

to the product to be sterilized; 

� when the notes have been entered, press the dedicated icon (arrow) to proceed to the cycle start menu. 

� NOTE 

Please refer to the technical manual of the machine for the configuration/modification of program parameters. 

� Start the sterilization cycle by pressing the START icon on the touch-screen. The machine performs 

sequentially a series of phases, which are displayed on the touch-screen. 

� NOTE 

The displayed phases depend on the hardware configuration of the machine and on the setting of the chosen 

software. 

Please refer to the technical manual of the machine for the characteristics of the standard phases and of the phases 

that can be enabled. 

� At the end of the sterilization program, the machine emits an acoustic signal; by pressing the STOP icon 

on the touch-screen (STOP), the Fedegari logo is displayed. The operator accesses the main menu by 

touching any point of the touch-screen. 

6.4.5. PRODUCT UNLOADING 

� From the main menu, press the touch-screen icon that indicates door opening in order to deflate the 

sealing gasket of the lid of the sterilization chamber; 

� lift the safety lever, which disengages the lid from the mechanical locking system; 

� open the lid by turning it counterclockwise. 

ID no. 85693 Rev. 2 24 / 31 July 2005



! WARNING! 

The opening of the lid of the sterilization chamber at the end of a cycle can be accompanied by the release of steam. 

Moreover, the internal parts of the chamber may remain at high temperature. Be particularly careful during unloading 

of the sterilized product and use adequate protective means. 

Removing bottles with an internal temperature that is still above 70°C may cause them to explode, with severe risks 

for the safety of nearby operators. For this purpose, in order to sterilize solutions contained in sealed bottles, select 

only sterilization processes with an appropriate final load cooling step and a counterpressure of sterile air that give 

assurances of safety during load extraction. The safety temperature above which the lid cannot be opened must be 

set to a value lower than 70°C and the “final check” parameter must be activated by setting the value 1. 

6.4.6. SHUTDOWN 

� Remove power from the machine by turning counterclockwise the main switch (from the ON position to the OFF 

position). 

� NOTE 

Before deactivating the machine remember to enter the STAND-BY password (0000): 

From the main menu: (Fedegari logo): 

� press the dedicated icon (Key) of the touch-screen to enter the password management menu; a keypad is 

displayed, allowing to enter the chosen password; when entered, enable the password by means of the 

confirmation icon. 

6.5. “PHASE STEP” AND “CYCLE STOP” FUNCTIONS 

During the execution of the sterilization program and until the process ends, normal operating interaction is disabled. 

It is nonetheless possible to act on the process in progress by activating specific functions (PHASE STEP and CYCLE STOP), which 

are described here. 

PHASE STEP function 

This function is activated by pressing the dedicated icon (descending steps) on the touch-screen. This allows to force the 

transition to the next operating phase, blocking the commands and actuations related to the operating phase in progress, 

without waiting for the preset phase end value to be reached, displaying and printing the “MANUAL PHASE-STOP” 

alarm. 

� NOTE 

The PHASE STEP function is not active during the SPONTANEOUS COOLING and AIR COOLING phases: 

CYCLE STOP function 

This function is activated by pressing the dedicated icon (exclamation mark) on the touch-screen. 

This allows to enter the emergency phase, from which, by pressing the dedicated STOP icon on the touch-screen, the 

atmospheric pressure balancing phase begins automatically, displaying and printing the “MANUAL PHASE-STOP” 

alarm. 

! WARNING! 

Use of the Phase Step and Cycle Stop functions is extremely dangerous for the load if, during the sterilization of 

liquids in hermetically-sealed containers, suddenly reaching atmospheric pressure would cause a pressure 

differential that is dangerous for the containers. 

Even in the case of containers that are not closed hermetically but are protected by filters, the pressure differential 

would cause the liquids to boil. 

Therefore, activate the Phase Step and Cycle Stop functions after making sure that the pressure in the chamber has 

reached atmospheric values spontaneously and that the temperature of the product is lower than 70°C. 

July 2005 25 / 31 ID no. 85693 Rev. 2

! WARNING! 



Before entering the atmospheric pressure balancing phase, check that the pressure and temperature conditions 

allow this operation without damaging the load. In particular, if the load is constituted by liquids, the load must be 

allowed to cool before pressing the STOP button. 

� NOTE 

Please refer to the technical manual of the machine for further details on the Phase Step and Cycle Stop functions. 

6.6. ALARM MESSAGES 

� NOTE 

Please refer to the technical manual of the machine for alarm message identification and management. 

6.7. EMERGENCY PHASE 

The emergency phase occurs in the sterilizer when: 

� a malfunction occurs during the sterilization process; 

� the machine restarts after an interruption caused by a blackout; 

� the machine restarts after the emergency button is activated; 

� the manual CYCLE STOP control (icon with exclamation mark) is activated. 

Activation of the emergency phase: 

- closes all the valves; 

- stops all the motors; 

- issues an acoustic alarm signal. 

Activation of the emergency phase places the autoclave in stand-by. This suspended state ensures the safety of the autoclave, of the 

personnel and of the load. 

6.8. AUXILIARY FUNCTIONS 

Some functions of the sterilizer are active even when the normal sterilization cycle is not being performed: 

� PRINT FUNCTION 

� CHANGE DATE AND TIME 

� OPERATOR PANEL FUNCTIONALITY CHECK 

� AUTODIAGNOSTICS 

� ALARM HISTORY MANAGEMENT 

� AUTOCLAVE DATA 

� NOTE 

Please refer to the technical manual of the machine for identification and management of the auxiliary functions. 

ID no. 85693 Rev. 2 26 / 31 July 2005



7. ALARMS AND TROUBLESHOOTING 

7.1. ALARMS 

The sterilizer manages some alarms, which are shown on the touch-screen together with a brief description and are 

printed if the printer is operating correctly and the associated function is activated. 

Occurrence of an alarm is indicated not only visually but also by the activation of an acoustic signal. 

The alarms are defined as: 

� system alarms, if they affect general safety conditions or instruments; 

� phase alarms, if they are linked to the execution of specific phases. 

Higher-level alarms, for example the alarm that indicates imperfect closure of the lid during the process, cause the cycle to be 

interrupted, passing immediately to the emergency phase, during which the autoclave is kept in a safe suspended condition. 

Pressing the dedicated (STOP) icon on the touch-screen that allows the operator to move on to the atmospheric 

pressure balancing phase and to the consequent cycle end. 

All alarms identify operating anomalies, which can be resolved spontaneously or can require technical intervention. 

� NOTE 

Please refer to the technical manual of the machine for an exhaustive list of the alarms, of the associated visual and 

acoustic signals, and of the procedures for troubleshooting any malfunctions. 

July 2005 27 / 31 ID no. 85693 Rev. 2

8. ORDINARY MAINTENANCE 



The maintenance operations described in this chapter have been defined after careful consideration of the average operating and 

utilization conditions of the machine. If your requirements are significantly different, you should contact the manufacturer promptly. 

When preparing an adequate sterilizer maintenance schedule, you should also consider that any period of inactivity of the machine 

must be taken into account in accordance with its duration. 

! WARNING! 

Before performing any maintenance on the sterilizer, unless otherwise prescribed, ALWAYS stop the machine, 

disengaging the main switch and disconnecting the machine from the mains electric power supply and from any 

other power sources. 

� NOTE 

Detailed instructions for performing correct ordinary maintenance are available in the technical manual of the 

machine. 

8.1. PREVENTIVE MAINTENANCE PROCEDURES 

This subsection lists the recommended procedural steps for performing correct ordinary preventive maintenance on the machine. 

These procedures are organized by subject, and list, in addition to any WARNING!s, their periodicity and the tools, materials and 

instruments to be used during maintenance. 

The procedures are organized according to the following subjects: 

� visual inspection; 

� cleaning; 

� periodic efficiency checks. 

8.1.1. VISUAL INSPECTION 

Once a week, visually check the integrity of the system and of its main components, paying particular attention to any leaks of the 

hydraulic circuit and to any damage to the electrical circuits. 

� NOTE 

An exhaustive list of the visual checks to be performed on the sterilizer is provided in the technical manual of the 

machine. 

8.1.2. CLEANING 

Normal cleaning of the sterilizer must be performed in accordance with the specifications of this subsection; specific products must be 

used for each part to be treated. The use of unsuitable substances or tools can cause severe damage to the machine and to its 

components. 

The parts of the sterilizer that require periodic cleaning to ensure their correct operation and to maintain the best levels of reliability 

and efficiency are: 

� sterilization chamber; 

� filter in the chamber; 

� temperature monitoring sensor; 

� devices for interfacing with the operator; 

� lid and external cabinet; 

� product transport drums; 

� line filter cleaning. 

ID no. 85693 Rev. 2 28 / 31 July 2005



� NOTE 

Detailed instructions for correct and safe cleaning of the parts listed above are available in the technical manual of 

the machine. 

8.1.3. PERIODIC EFFICIENCY CHECKS 

It is recommended to perform periodically the following checks in order to ensure correct and safe operation over time of the sterilizer 

with full efficiency: 

� chamber and generator safety valve check; 

� manual chamber discharge valve check; 

� chamber tightness test (only if the vacuum pump is installed); 

� chamber pressure test (only if the function for pressurization with compressed air is provided); 

� lid sealing gasket check; 

� gasket compressed-air system tightness check; 

� Pt100 temperature monitoring sensor check; 

� lid opening safety system temperature check; 

� compressed air reduction unit check (only if electric valve for introducing compressed air is installed); 

� temperature monitoring sensor calibration; 

� pressure transducer calibration; 

� printer check. 

� NOTE 

Detailed instructions for performing the periodic efficiency checks listed above are provided in the technical manual 

of the machine. 

8.2. CORRECTIVE MAINTENANCE PROCEDURES 

� Removing jams; 

� replacing the battery of the process controller; 

� replacing the sterile filter; 

� replacing the power supply cable (if damaged); 

� replacing fuses. 

8.2.1. REMOVING JAMS 

If the paper of the printer jams, proceed as follows in order to remove it: 

1. open the printer access door; 

2. remove the paper roll; 

3. remove the paper from the insertion slot, thus removing the jam; 

4. cut off the jammed and damaged piece of paper with a neat cut and remove it from the roll; 

5. reinsert the paper roll; 

6. insert the flap of the paper in the insertion slot; 

7. close the printer access door. 

� NOTE 

Detailed instructions for performing corrective maintenance procedures, except for the jam removal procedure 

described above, are contained in the technical manual of the machine. 

July 2005 29 / 31 ID no. 85693 Rev. 2

9. REMOVAL FROM SERVICE 



The machine must be removed from service in compliance with the applicable statutory provisions of the country of destination. 

Before any operation for removal from service, disconnect the machine from the electric, water and pneumatic mains. 

In particular it is recommended to: 

� clear the sterilization chamber of any residue of material that has been treated, partially treated or is yet to be treated; 

� empty the hydraulic and pneumatic circuits completely; 

� eliminate the power supply cable from the autoclave by disconnecting it from the input terminal strip provided on board the 

machine or by cutting it. 

; CAUTION 

Abandoning machines removed from service outside of the areas reserved for this purpose is contrary to the 

principles of respect and protection of the environment, and in some countries is punished by fines and penalties. 

ID no. 85693 Rev. 2 30 / 31 July 2005



10. TECHNICAL SUPPORT 

FEDEGARI is at the complete disposal of its Customers for any intervention, either directly or indirectly via its local agents/dealers. 

Specialized personnel and equipment is available for overhauling and repairs. The names and addresses of FEDEGARI SUPPORT 

SERVICES in Switzerland and abroad can be requested from FEDEGARI AUTOKLAVEN AG - Via alla Gerra, 11 - CH-6930 Bedano 

- SWITZERLAND. 

The machine is covered by warranty in accordance to the General Terms of Sale of the specific contract. 

The warranty becomes void if: 

- repairs are made without the approval of the manufacturer or of the FEDEGARI Support Service; 

- original spare parts are not used; 

- the machine is used for purposes other than its intended use; 

- the prescriptions given in this document are not observed. 

; CAUTION 

FEDEGARI will not take responsibility for any abnormal operation, malfunction and anomaly arising from failure to 

apply the ordinary maintenance procedures specified by the manufacturer and given in this manual. 

July 2005 31 / 31 ID no. 85693 Rev. 2

FVA/A1 STERILIZERS

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