Fona Hygenius Operating Instructions PDF

CLOSER TO YOU
FONA Hygenius 17
FONA Hygenius 22
Operating instructions
English
FONA Hygenius 17
FONA Hygenius 22
REVISIONS
The following table lists subsequent editions/revisions of the manual.
The “Description” field brief explains the subject of the latest revision.
Code Rev. Date Description

97050767 0 07-2014 First issue (translation from the original in Italian)
TABLE OF CONTENTS
INTRODUCTION.....................................................................................................................................1
SYMBOLS USED IN THE MANUAL................................................................................................................................ 1
SYMBOLS ON EQUIPMENT........................................................................................................................................... 1
APPLICABLE EUROPEAN DIRECTIVES............................................................................................................................. 1
INTENDED USE.................................................................................................................................................................... 1
IMPORTANT NOTES.......................................................................................................................................................2
PURPOSE OF THE MANUAL .............................................................................................................................................. 2
GENERAL WARNINGS......................................................................................................................................................... 2
CONTENTS OF THE PACKAGE............................................................................................................3

DIMENSIONS AND WEIGHT................................................................................................................................................ 3
DESCRIPTION OF THE CONTENTS................................................................................................................................... 3
HANDLING THE PRODUCT................................................................................................................................................. 4
PRODUCT INTRODUCTION..................................................................................................................5
INTRODUCTION................................................................................................................................................................... 5
GENERAL CHARACTERISTICS........................................................................................................................................... 5
FRONT................................................................................................................................................................................... 6
REAR .................................................................................................................................................................................... 7
LCD ICONS........................................................................................................................................................................... 8
OPERATING CYCLE EXAMPLE........................................................................................................................................... 9
INSTALLATION.....................................................................................................................................10
INTRODUCTION................................................................................................................................................................. 10
COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATIONS..................................................................................... 10
GENERAL INSTALLATION PRECAUTIONS ...................................................................................................................... 11
ELECTRICAL CONNECTIONS........................................................................................................................................... 11
DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT..................................................................................... 12
FIRST START-UP.................................................................................................................................13
TURNING ON THE EQUIPMENT........................................................................................................................................ 13
MAIN MENU ....................................................................................................................................................................... 14
FILLING DISTILLED WATER ............................................................................................................................................. 15
MANUAL FILLING..........................................................................................................................................................15
AUTOMATIC FILLING.................................................................................................................................................... 15
CONFIGURATION................................................................................................................................16
SETTINGS........................................................................................................................................................................... 16
PREPARING THE MATERIAL..............................................................................................................21

INTRODUCTION................................................................................................................................................................. 21
TREATING THE MATERIAL BEFORE STERILIZATION..................................................................................................... 21
ARRANGING THE............................................................................................................................................................... 22
LOAD................................................................................................................................................................................... 22
STERILIZATION CYCLES ..................................................................................................................24
EXTRA DRYING....................................................................................................................................26
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RUNNING THE CYCLE....................................................................................................................................................... 27

RESULT OF THE CYCLE.................................................................................................................................................... 27
DOOR OPENING AT CYCLE END...................................................................................................................................... 27
MATERIAL STORAGE......................................................................................................................................................... 28
TEST PROGRAMS...............................................................................................................................29
INTRODUCTION................................................................................................................................................................. 29
CYCLE HELIX TEST/B&D................................................................................................................................................... 29
CYCLE VACUUM TEST...................................................................................................................................................... 31
DOOR OPENING................................................................................................................................................................ 33
USED WATER DRAIN......................................................................................................................................................... 34
DETACHING THE PIPE.................................................................................................................................................34
MANUAL INTERRUPTION ................................................................................................................................................. 35
DATA MANAGEMENT..........................................................................................................................36
APPENDIX – TECHNICAL CHARACTERISTICS................................................................................40

SUMMARY TABLE.............................................................................................................................................................. 40
SAFETY DEVICES.............................................................................................................................................................. 41
WATER SUPPLY CHARACTERISTICS.............................................................................................................................. 42
APPENDIX – PROGRAMS...................................................................................................................43
INTRODUCTION................................................................................................................................................................. 43
PROGRAM SUMMARY TABLE – 17................................................................................................................................... 44
PROGRAM SUMMARY TABLE – 22................................................................................................................................... 45
STERILIZATION PROGRAM DIAGRAM............................................................................................................................. 46
DIAGRAMS OF THE TEST PROGRAMMES...................................................................................................................... 48
EXAMPLES OF PRINTED REPORTS................................................................................................................................ 49
APPENDIX – MAINTENANCE..............................................................................................................50
INTRODUCTION................................................................................................................................................................. 50
ORDINARY MAINTENANCE PROGRAM........................................................................................................................... 50
SCHEDULED MAINTENANCE MESSAGES................................................................................................................. 50
MAINTENANCE DESCRIPTION ........................................................................................................................................ 52
CLEAN GASKET AND PORTHOLE.............................................................................................................................. 52
CLEAN EXTERNAL SURFACES................................................................................................................................... 52
CLEAN STERILIZATION CHAMBER AND ACCESSORIES ........................................................................................ 52
DISINFECT EXTERNAL SURFACES............................................................................................................................ 52
BOILER FILTER CLEANING......................................................................................................................................... 53
REPLACE THE BACTERIOLOGICAL FILTER.............................................................................................................. 53
BOILER GASKET REPLACEMENT.............................................................................................................................. 53
PERIODIC STERILIZER VALIDATION................................................................................................................................ 54
DISPOSAL AT END-OF-LIFE.............................................................................................................................................. 54
APPENDIX – GENERAL PROBLEMS.................................................................................................55

INTRODUCTION................................................................................................................................................................. 55
ANALYSIS AND RESOLUTION OF PROBLEMS................................................................................................................ 55
APPENDIX – ALARMS.........................................................................................................................57
INTRODUCTION................................................................................................................................................................. 57
ALARM INTERVENTION..................................................................................................................................................... 57
ALARM DURING A CYCLE............................................................................................................................................ 57
SYSTEM RESET...................................................................................................................................58
ALARM CODES................................................................................................................................................................... 59
ANALYSIS AND RESOLUTION OF PROBLEMS................................................................................................................ 63
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APPENDIX – ACCESSORIES..............................................................................................................72
PRINTER CONNECTION.............................................................................................................................................. 73
APPENDIX – TECHNICAL SUPPORT.................................................................................................74
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INTRODUCTION Dear Customer
Thank you for choosing the FONA Hygenius. We hope that you will find it completely satisfactory.
This manual describes all procedures for the correct use of the device and instructions for deri-
ving the full benefit from its features.
In any case, we will be available to provide explanations and to receive any suggestions you may
have for improving our products or services.
Symbols used in the NOTE
manual PAY PARTICULAR ATTENTION TO THE PARAGRAPHS MARKED WITH THIS
SYMBOL.
WARNING
THIS SYMBOL INDICATES A POTENTIAL DANGER OF INJURY. FOLLOW
THE PROCEDURES DESCRIBED IN THE MANUAL TO AVOID INJURING
THE USER AND/OR OTHERS.
DANGER
THIS SYMBOL INDICATES A POTENTIAL DANGER OF PROPERTY DAMAGE.
FOLLOWS THE INSTRUCTIONS IN THE MANUAL TO PREVENT POTENTIAL
DAMAGE TO MATERIALS, EQUIPMENT OR OTHER PROPERTY.
DANGER
THIS SYMBOL INDICATES A POTENTIAL DANGER DUE TO HIGH TEMPERA-
TURE.
THE MATERIAL THE STERILIZER IS COMPOSED OF MUST BE DISPOSED

ACCORDING TO THE DIRECTIVE 2002/96/CEE
Symbols on
equipment Potenzial hazard due to high temperature.
Equipment in accordance with applicable directives.
Symbol for disposal in accordante with Directive 2002/95 EC, 2002/96/ EC,
and 2003/108/ EC.
Consult the user manual.
APPLICABLE The FONA Hygenius described in this manual is manufactured in accordance with the highest sa-
EUROPEAN fety standards and doesn't represent any danger for the operator if used according to the following
instructions. The product is in accordance with the following European Directive as applicable:
DIRECTIVES
2006/95/CE, for the approximation to the legislation of the Members States related to low vol-
tage equipment.
2004/108/CE, for the approximation to the legislation of the Members States related to the elec-
tromagnetic compatibility;
93/42CEE and subsequent changes, concerning the medical devices.
2011/65/UE, (Rohs 2) on the restriction of the use of certain hazardous substances in electrical
INTENDED USE and electronic equipment.
The product described in this manual is intended exclusively for sterilization of reusable
surgical instruments and materials.
DEVICE INTENDED FOR PROFESSIONAL USE AND NOT FOR SALE TO THE GENERAL
PUBLIC.
WARNING
THE DEVICE MUST ONLY BE USED BY QUALIFIED PERSONNEL. IT MAY
NOT BE USED OR HANDLED BY INEXPERT AND/OR UNAUTHORIZED
PERSONNEL FOR ANY REASON.
THIS DEVICE MUST NOT BE USED FOR THE STERILIZATION OF FLUIDS,
LIQUIDS OR PHARMACEUTICAL PRODUCTS.
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Important notes
NOTE
THE MANUAL INFORMATION ARE SUBJECT TO CHANGES WITHOUT ANY
NOTICE.
THE MANUFACTURER IS NOT RESPONSIBLE FOR DIRECT, INDIRECT OR
ACCIDENTAL DAMAGE RESULTING FROM OR RELATING TO THE PROVI-
SION OR USE OF THIS INFORMATION.
THIS DOCUMENT MAY NOT BE REPRODUCED, ADAPTED OR TRANSLA-
TED, IN PART OR IN FULL, WITHOUT THE PRIOR WRITTEN PERMISSION
OF THE MANUFACTURER.
PURPOSE OF
The purpose of this manual is to provide instructions for:
THE MANUAL
–– becoming generally familiar with the product;
–– its correct installation and configuration;
–– its safe, efficient use;
–– handling materials before and after sterilization.
Its APPENDIXs also provide:
–– the product's general technical specifications;
–– sterilization program specifications;
–– maintenance;
–– troubleshooting;
–– a variety of other documentation.
GENERAL
WARNINGS When using this product, always follow the instructions in the manual and never use for anything
other than its intended purpose.
WARNING
THE USER IS RESPONSIBLE FOR ALL LEGAL REQUIREMENTS RELATED
TO THE INSTALLATION AND USE OF THIS PRODUCT. THE MANUFACTU-
RER WILL NOT BE RESPONSIBLE FOR ANY BREAKAGE, MALFUNCTIONS,
PROPERTY DAMAGE OR INJURY IN THE EVENT THAT THE PRODUCT IS
NOT INSTALLED OR USED CORRECTLY.
Please observe the following precautions in order to avoid injury or property damage:
–– Use ONLY high-quality demineralised and/or distilled water.
WARNING
THE USE OF WATER OF INADEQUATE QUALITY CAN SEVERELY DAMAGE
THE DEVICE.
SEE APPENDIX TECHNICAL CHARACTERISTICS IN THIS REGARD.
–– Do not pour water or other liquids on the device;

–– Do not pour inflammable substances on the device;
–– Do not use the device in the presence of gas or explosive or inflammable vapors;
–– Before performing any maintenance or cleaning, ALWAYS DISCONNECT the electricity.
DANGER
WHENEVER IT IS NOT POSSIBLE TO DISCONNECT THE ELECTRICITY TO
THE DEVICE, OR IF THE EXTERNAL POWER GRID SWITCH IS FAR AWAY
OR, AT ANY RATE, NOT VISIBLE TO THE MAINTAINER, PLACE A WORK IN
PROGRESS SIGN ON THE EXTERNAL POWER GRID SWITCH AFTER TUR-
NING IT OFF.
–– Make sure the electrical system is grounded conforming to current laws and/or standards;
–– Do not remove any label or nameplate from the device; request new ones, if necessary.
–– Use only original replacement parts.
WARNING
THE FAILURE TO OBSERVE THE ABOVE, RELEASES THE MANUFACTU-
RER FROM ALL LIABILITY.
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CONTENTS OF NOTE
THE PACKAGE CHECK THE INTEGRITY OF THE
PACKAGE UPON RECEIPT.
DIMENSIONS Once the package is opened, check that:
AND WEIGHT –– the supply matches the specifications of the order
(see the accompanying document);
–– that there is no obvious product damage; A
Dimensions and weight 17 lt 22 lt

A. Height 600 mm 600 mm
B. Width 580 mm 580 mm B C
C. Depth 700 mm 800 mm
Total weight 62 kg 68 kg
NOTE
IN THE CASE OF A WRONG PRODUCT, MISSING PARTS OR ANY TYPE
OF DAMAGE, IMMEDIATELY PROVIDE A DETAILED DESCRIPTION TO THE
DISTRIBUTOR AND THE TRANSPORTER THAT MADE THE DELIVERY.
DESCRIPTION OF
THE CONTENTS
1 4
6
5
2
3
In addition to the steriliser, the package contains:
1. No. 5 stainless steel wire instrument tray;

2. Stainless steel wire tray support;
3. Printed Quick Operation Guide with included User Guide on CD-ROM;
4. Tray extractor;
5. Rubber hose with quick-coupling for manual water drainage;
6. Water filling funnel.
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HANDLING THE Where possible, the packaged product must be handled using suitable mechanical means (forklift
PRODUCT truck, transpallet, etc.) and following the instructions shown on the package.
In the case of manual handling, the product must be lifted by two persons using the handles cut
in the side of the box.
Once the sterilizer has been taken out of the box, it must be lifted by two persons using appro-
priate means.
WARNING
WE RECOMMEND THAT THE DEVICE BE TRANSPORTED AND STORED
AT A TEMPERATURE NO LOWER THAN 5 °C. PROLONGED EXPOSURE TO
LOW TEMPERATURE AN DAMAGE THE PRODUCT.
NOTE
KEEP THE ORIGINAL PACKAGING AND USE IT WHENEVER THE DEVICE IS
TO BE TRANSPORTED. THE USE OF DIFFERENT PACKAGING COULD DA-
MAGE THE PRODUCT DURING SHIPMENT.
DANGER
BEFORE TRANSPORT, LEAVE THE DEVICE TURNED-OFF FOR ABOUT 30
MINUTES AFTER THE LAST PROGRAM FINISHES AND DRAIN THE DISTIL-
LED WATER AND USED WATER TANKS SO THAT THE ALL THE HOT INTER-
NAL PARTS WILL HAVE TIME TO COOL.
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PRODUCT The Hygenius 17 and Hygenius 22 series sterilisers are a revolutionary product offered by
FONA in the field of water steam sterilisers, equipped with type B (EN 13060) cycles, as well as
INTRODUCTION the new point of reference with respect to safety, performance, flexibility and ease of use.
INTRODUCTION It is a sophisticated but, at the same time, easy to use device that, thanks to its wide range of
configuration options and patented operating devices, satisfies every need for sterilizing medical
devices, guaranteeing the maximum performance under all conditions.
It also features a better way of relating to users who, rather than having to adapt to the machine
and its characteristics, are able to "converse" with it and configure it to meet their own needs.
Thanks to its remarkable ease of use, compact size and pleasant appearance, it is the ideal part-
ner for all professionals who demand the maximum sterilization safety.
A Hygenius 17 and Hygenius 22 series steriliser is an electronic water steam steriliser that is
entirely operated by a micro-processor with a large, printed stainless steel sterilisation chamber.
GENERAL It is characterized by an advanced fractionated vacuum system for the complete removal of air,
CHARACTERISTICS even from hollow, porous materials, and an effective final vacuum drying phase capable of elimi-
nating all traces of humidity from any load.
Its exclusive steam generation system, effective plumbing circuit and electronic management
(supplemented by high-precision sensors) guarantees high process execution speeds and excel-
lent thermodynamic parameter stability.
Moreover, its Process Evaluation System constantly monitors all the machine's “vital” parameters
in real-time, guaranteeing absolute safety and a perfect result.
It offers users 6 sterilization programs (of which one completely PRESETble), all equipped with
customizable, optimized drying for and fast, effective sterilization of various types of loads (instru-
ments and materials) used in a medical environment.
All the cycles can immediately be selected on the clear LCD screen, which also allows extensive
configuration of the device according to the user’s needs.
Please refer to the chapter, “Configuration” for more detail.
The new range of autoclaves Hygenius 17 and Hygenius 22 have the most complete, sophisti-
cated and advanced safety systems available today, giving the user a peace of mind against any
electrical, mechanical, thermal or functional fault.
NOTE
FOR THE DESCRIPTION OF THE SAFETY DEVICES, REFER TO THE APPEN-
DIX TECHNICAL CHARACTERISTICS.
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FRONT
LCD display and con-

trol panel
On/Off switch
Door
Door
Sterilization chamber
Door microswitch
Door closing system
Bacteriological filter
USB port
Water drain filter
Door
Distilled water tank drain quick-cou-

pling (SERVICE only)
Used water drain quick connector
Door
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REAR
Heat exchanger
Connection for
automatic distil-
led water filling
Connection for
Direct water drai-
nage
Serial cable connection
Power cable connection
Automatic filling electrical connection

Mains fuses
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LCD ICONS
DATE TIME
11/04/13 10:54
SELECTION
ICONS
CLOSER TO YOU
OK
CONFIRMATION
BUTTON
DOOR OPENING
BACKWARD FORWARD
BUTTON BUTTON
Selection of the sterilizer settings (SETUP)
Selection for data management
Sterilization cycle selection
Selection of the test cycles
NOTE
OTHER PARTICULAR SYMBOLS RELATING TO THE VARIOUS CONDITIONS
OF USE WILL BE DESCRIBED IN THE RELATIVE PARAGRAPHS.
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OPERATING CYCLE The Hygenius series sterilisation programme can be effectively described as a succession of
EXAMPLE phases, each one with a very precise objective.
For example, the universal program (cycle B, 134°C - 4’): after loading the material in the cham-
ber, closing the door, selecting the program and starting the cycle (after locking the door opening
mechanism), the following sequence will be suggested (see the graph below):
1. preheating the generator and sterilization chamber;

2. removing the air and penetration of the material by steam through a series of vacuum
(extraction of the fluid from the sterilization chamber) and pressure(injection of steam into the
chamber) phases;
3. raising the pressure, with the consequent increase in the temperature of the steam, until
reaching the conditions required for sterilization (in the example, 134 °C);
4. stabilizing the pressure and temperature;
5. sterilizing for the required time (in the example, 4 minutes);
6. depressurizing the sterilization chamber;
7. vacuum-drying phase;
8. ventilating the load with sterile air;
9. bringing the pressure of the sterilization chamber back to the atmospheric level.
Having reached this last phase, you can unlock the door and remove the load from the steriliza-
tion chamber.
It should be emphasized that phases 1, 3, 4, 6 and 9 are identical in all cycles, with slight varia-
tions of duration that are solely dependent on the quantity and consistency of the load and the
heating conditions of the sterilizer while phases 2, 5, 7 and 8 clearly vary their configuration and/
or duration on the basis of the cycle selected (and, as a consequence, the type of load) and the
choices made by the user.
P res s ure (bar)
P R OC E SS
2.10
2.00
1.00
Time (min)
0.00
-0.80
SINGLE VACUUM PULSE VACUUM DRYING
NOTE
PLEASE REFER TO APPENDIX PROGRAMS FOR MORE DETAIL.
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INSTALLATION
The first and fundamental step in achieving good sterilizer operation, long life and complete use
INTRODUCTION of its features is a correct, careful installation. Moreover, this precaution will avoid the danger of
physical injury or property and damage, not to mention malfunctions and damage to the machine.
So, please follow the instructions in this chapter precisely.
NOTE
CUSTOMER SUPPORT (SEE APPENDIX) WILL ANSWER YOUR QUESTIONS
AND PROVIDE ADDITIONAL INFORMATION.
THE STERILIZER HAS PASSED ALL REQUIRED INSPECTIONS BEFORE
BEING PLACED ON THE MARKET. IT DOES NOT REQUIRE ANY ADDITIONAL
CALIBRATION BEFORE BEING PLACED IN SERVICE.
Dimensions and weight 17lt 22lt

A. Height (total) 420 mm 420 mm B
B. Width (total) 480 mm 480 mm

A
C. Depth (excluding rear
560 mm 660 mm
connections)
Total weight 58 kg 63 kg
Electricity.
The electrical system to which the sterilizer will be connected must be suitably dimensioned ba-
sed on the electrical characteristics of the device. This information is shown on the back of the
machine.
When installing the sterilizer inside a cabinet, you

COMPARTMENT must provide adequate space all around the device
DIMENSIONS to provide effective ventilation as well as a large B C
enough opening in the back that, in addition to
FOR BUILT-IN
allowing the passage of the power cord will also
INSTALLATIONS provide an adequate air flow and the consequent
optimum cooling of the heat exchanger.
A
The compartment where the steriliser will be kept
must have the following minimum dimensions:
Dimensions 17lt 22lt

A. Height 500 mm 500 mm
B. Width 600 mm 600 mm
C. Depth 600 mm 700 mm
WARNING
COMPARTMENT DIMENSIONS LESS THAN THOSE SHOWN MAY COM-
PROMISE THE CORRECT CIRCULATION OF AIR AROUND THE DEVICE
AND MAY NOT PROVIDE ADEQUATE COOLING, WITH THE CONSEQUENT
DETERIORATION OF PERFORMANCE AND/OR POSSIBLE DAMAGE.
NOTE
IF THE FILLING AND DRAINAGE DOORS ARE NOT ACCESSIBLE FROM THE
TOP AFTER THE DEVICE HAS BEEN BUILT IN, IT IS ADVISABLE TO USE THE
FRONT ATTACHMENTS (FRONT FILLING KIT).
IF THE MAIN SWITCH IS INACCESSIBLE WHEN INSTALLED IN THE COM-
PARTMENT, USE AN ELECTRIC PLUG THAT INCORPORATES AN ON/OFF
SWITCH.
DO NOT REMOVE THE UPPER COVER OR ANY OTHER EXTERNAL PART.
WHEN INSTALLED IN THE COMPARTMENT, THE DEVICE MUST BE COM-
PLETE WITH ALL ITS PARTS.
PLEASE REFER TO APPENDIX TECHNICAL CHARACTERISTICS FOR COM-
PLETE TECHNICAL DATA.
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GENERAL Obey the following warnings for the correct operation of the device and/or to avoid risky situa-
INSTALLATION tions:
PRECAUTIONS –– Install the sterilizer on a flat and perfectly horizontal surface.
–– Make sure that the support surface is strong enough to support the equipment weight (about
60 kg);
–– Leave adequate space for ventilation (at least 10 cm on each side) all around the sterilizer,
especially in back.
–– If the device is built-in to a cabinet, be sure to respect the warnings in the preceding paragraph,
avoiding an obstructions to the air intake;
–– Do not install the sterilizer near tubs, sinks or similar places, to avoid contact with water or
liquids. This could cause short circuits and/or potentially dangerous situations for the operator;
–– Do not install the sterilizer in a place that is excessively humid or poorly ventilated;
–– Do not install the machine were there is gas or inflammable and/or explosive vapors;
–– Install the device so that the power cord is not bent or crushed. It must run freely all the way
to the socket.
–– Install the device that any external fill/drain tubing is not bent or crushed. They must run freely
to the drain tank.
ELECTRICAL The sterilizer's must be connected to a socket of the electrical system of adequate capacity for
CONNECTIONS the device's absorption and ground provided, in conformity with current laws and/or standards.
The socket must be suitably protected by a breaker having the following characteristics:
–– Nominal current In 16 A
–– Differential current IDn 0,03 A
WARNING
THE MANUFACTURER WILL NOT BE LIABLE FOR DAMAGES CAUSED BY
INSTALLING THE STERILIZER ON AN INADEQUATE ELECTRICAL SYSTEM
AND/OR NOT EQUIPPED WITH A GROUND.
NOTE
ALWAYS CONNECT THE POWER CORD DIRECTLY TO THE SOCKET. DO
NOT USE EXTENSION CORDS, ADAPTERS OR OTHER ACCESSORIES.
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DIRECT CONNECTION
– Remove the cap holding clip on the rear of the autoclave.
TO A CENTRALIZED
DRAINING POINT – Fit the plastic tube on the elbow union.
– Fit the union and then refit the clip.
–– Fasten a clip to the drain siphon.
–– Cut the hose to the right length and insert its free end into the centralized draining connector
locking it with the dedicated ring nut.
NOTE
MAKE SURE THE TUBE IS NOT BENT, CRUSHED OR OBSTRUCTED IN ANY
WAY.
The following diagram provides an indicative arrangement of the components:
Drain
Support siphon
plane
Clamp
To the centralized
draining point
NOTE
THE CONNECTION POINT TO THE CENTRAL DRAIN MUST BE LOWER
THAN THE STERILIZER'S SUPPORT SURFACE. OTHERWISE, THE TANK
MAY NOT EMPTY CORRECTLY.
NOTE
FOR AUTOMATIC FILLING SYSTEMS (PUMP, EV AUX) THE DIRECT DRAIN
MUST ALWAY S BE CONNECTED.
THIS ACTS AS AN OVERFLOW, AND, IF FOR SOME REASON, THE FILLING
SYSTEM DOES NOT STOP, THE WATER SEEPS FROM THE FEED TANK
INTO THE DRAIN TANK AND FLOWS OUT THE DIRECT DRAIN, THUS PRE-
VENTING FLOODING.
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FIRST START-UP
TURNING ON THE Once the sterilizer has correctly been installed, turn it on with the main switch on the right-hand
EQUIPMENT side of the machine.
When the sterilizer is turned on, the following page appears:
CLOSER TO YOU
Ver. B.21
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MAIN MENU Once the start procedure has been completed, the main menu shown below appears on the
display.
14/10/14 10:54
CLOSER TO YOU
OK
The device waits for selection of the desired program (see section “Program Selection”).
DANGER
TO PREVENT BURNS, BE CAREFUL NOT TO TOUCH THE STERILIZA-

TION CHAMBER, THE CHAMBER EQUIPMENT OR THE INSIDE OF THE
DOOR WITH BARE HANDS.
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FILLING DISTILLED The distilled water tank must be filled or topped up when using the sterilizer for the first time, and
WATER when the water MIN level icon comes on .
Operate as follows (with the machine on) referring to the figure:
1. Remove the rubber cap;
Manual filling
2. Insert the filling funnel provided in the fillercap;
3. Slowly pour the distilled water into the funnel until the MIN icon goes off ;
4. Continue filling with water until reaching the maximum level in the filling tank, indicated by the
MAX icon coming on, accompanied by an acoustic warning.
Immediately stop filling; under no circumstances exceed the MAX limit indicated at the bottom of
the fillercap.
Be careful not to spill any water on the machine; if so, immediately dry it off.
5. Remove the funnel from the fillercap;
6. Refit the rubber cap.
NOTE
THE MAX LEVEL ICON DOES NOT NEED TO BE ON FOR THE STERILIZA-
TION PROGRAM TO BE STARTED. SIMPLY MAKE SURE THAT THE MIN LE-
VEL ICON OFF.
Automatic filling Refer to the Appendix "ACCESSORIES".
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CONFIGURATION The Hygenius series offers a wide range of customisation options. The user can thus configure
the device according to need, adapting the performance based on, for example, the type of acti-
vity carried out, the type of material to be sterilized and the frequency of use.
Using the configuration program, the user can set a series of options available in user-friendly
menus.
NOTE
USE THE SETUP PROGRAM WHENEVER NECESSARY. A CORRECTLY PER-
SONALIZED DEVICE PROVIDES THE BEST PERFORMANCE AND THE MOST
SATISFACTORY USE.
CUSTOMER SUPPORT (SEE APPENDIX) IS AVAILABLE TO HELP USERS BY

PROVIDING SUGGESTIONS OR ADVICE ON THE BEST WAY TO USES THE
OPTIONS IN THE SETUP PROGRAM.
SETTINGS To access the configuration program, select the icon below and press OK.
11/04/13 10:54
CLOSER TO YOU
OK
LANGUAGE
Select the LANGUAGE option and confirm by pressing the OK button.
Language
CLOSER TO YOU
Date and Time

OK
Inglese
Italiano
Spagnolo
CLOSER TO YOU
OK
Select the desired language by scrolling the list with the arrows (r and s) and confirm by pres-
sing the OK button.
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DATE AND TIME
Select the DATE AND TIME option and confirm by pressing the OK button.
Language
Date and Time

CLOSER TO YOU
Users
OK
DD MM YYYY
12 / 04 / 2013
±hh hh mm ss
CLOSER TO YOU
+1 11 : 34 : 15
OK
Select the field to be modified using the arrows and confirm with OK.
DD MM YYYY
12 / 04 / 2013
CLOSER TO YOU
±hh hh mm ss
+1 11 : 34 : 15
OK
Act on the + and – buttons to change the value.

Confirm with OK and continue with modifying the other fields.
Press the EXIT icon to save the selections made and go back to the previous menu.
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STANDBY
Select the STANDBY option and confirm by pressing the OK button.
Users
Standby
CLOSER TO YOU
Water filling
OK
Standby
Status ON
CLOSER TO YOU
Intervall 10’
OK
Standby
Status ON
CLOSER TO YOU
Intervall 10’
Select ON to activate heating in STANDBY or OFF to deactivate it.

Confirm by pressing OK.
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WATER FILLING
Select the WATER FILLING option and confirm by pressing the OK button.
Standby
Water filling
CLOSER TO YOU
Screen
OK
External pump
SV AUX
CLOSER TO YOU
Manual filling
OK
Select the desired option based on the accessory actually connected and confirm with OK.
NOTE
WHEN THE AUTOMATIC FILLING SYSTEM IS CONNECTED, THE STERI-
LIZER ASKS YOU TO IDENTIFY THE TYPE OF DEVICE ACTUALLY CON-
NECTED BY PRESSING THE CORRESPONDING BUTTON.
IF THE FILLING SYSTEM IS CONNECTED WHEN THE STERILIZER IS OFF,
ACCESS THE MENU VIA THE CONFIGURATION PROGRAM AND MANUALLY
SELECT THE CORRECT OPTION.
NOTE
THIS MENU CAN ALSO BE USED TO TEMPORARILY DEACTIVATE THE AU-
TOMATIC FILLING SYSTEM (FILTERS EXHAUSTED, FAULTY, ETC.) AND GO
TO MANUAL TANK FILLING.
SV AUX
Manual filling
CLOSER TO YOU
OK
Select "Manual filling" and confirm with OK.
19
FONA Hygenius 17
FONA Hygenius 22
SCREEN
Select the SCREEN option to adjust the screen brightness and contrast and confirm with OK.
Water filling
Screen
CLOSER TO YOU
Service
OK
Screen
Brightness 100%
CLOSER TO YOU Contrast 5%
OK
Screen
Brightness 100%
CLOSER TO YOU Contrast 5%
OK
Select the field to be modified using the arrows and confirm with OK.
SERVICE
This menu is reserved for Technical Service. It may only be used by an authorised technician.
Screen
Service
CLOSER TO YOU
OK
20
FONA Hygenius 17
FONA Hygenius 22
PREPARING THE First of all, it should be recalled that, when handling and managing contaminated material, it is
a good idea to take the following precautions:
MATERIAL
–– Wear rubber gloves of adequate thickness;
–– Clean your gloved hands with a germicide detergent;
INTRODUCTION
–– Always carry the instruments on a tray;
–– Never carry them in your hands;
–– Protect your hands from contact with any sharp points or edges; this will avoid the risk of
contracting a dangerous infection;
–– Immediately remove any article that does not need to be sterilized or that is not capable of
withstanding the process;
–– Carefully wash your still gloved hands when done handling non-sterile material.
All materials and/or instruments to be sterilized must be perfectly clean, without any type of re-
sidue (deposits of organic/inorganic material, fragments of paper, cotton/gauze pads, lime, etc.).
NOTE
IN ADDITION TO CAUSING PROBLEMS DURING STERILIZATION, THE FAI-
LURE TO CLEAN AND REMOVE RESIDUE CAN DAMAGE THE INSTRU-
MENTS AND/OR THE STERILIZER, ITSELF.
TREATING THE An effective cleaning consists of the following:

MATERIAL BEFORE 1. Rinse the instruments under running water immediately after use;
STERILIZATION
2. Separate metal instruments by type of material (carbon steel, stainless steel, brass, aluminum,
chromium, etc.), to avoid electrolytic oxidation-reduction;
3. Clean the instrument with an ultrasound device containing a mixture of water and germicide
solution carefully following the manufacturer’s recommendations, or use a heat disinfector;
4. For best results, use a detergent specifically designed for ultrasound washing, with a neutral pH.
NOTE
SOLUTIONS CONTAINING PHENOLS OR QUATERNARY AMMONIA COM-
POUNDS CAN CAUSE CORROSION ON INSTRUMENTS AND THE METAL
PARTS OF ULTRASOUND DEVICES.
5. After washing, carefully rinse the instruments and make sure that residues have been
completely eliminated; if necessary, repeat the washing cycle or clean manually.
NOTE
TO AVOID THE FORMATION OF LIME SPOTS, RINSE WITH DEIONIZED OR
DISTILLED WATER, IF POSSIBLE. WHENEVER VERY HARD TAP WATER IS
USED, WE RECOMMEND ALWAYS DRYING THE INSTRUMENTS.
For hollow instruments (turbines, contra-angles, etc.), supplement the above with treatment in
suitable dedicated devices that provide effective internal cleaning (occasionally including lubri-
cation).
NOTE
THE END OF THE STERILIZATION PROGRAM, REMEMBER TO LUBRICATE
THE INTERNAL HANDPIECE MECHANISMS USING SPECIAL STERILE OIL.
BY TAKING THESE PRECAUTIONS, THE INSTRUMENTS LIFE TIME WILL
NOT BE REDUCED IN ANY WAY.
WARNING
CONSULT THE INSTRUCTIONS PROVIDED BY THE MANUFACTURER OF
THE INSTRUMENT/MATERIAL TO BE STERILIZED BEFORE SUBJECTING
IT TO AUTOCLAVE TREATMENT, CHECKING FOR ANY INCOMPATIBILITIES.
EXACTLY FOLLOW THE METHODS OF USING DETERGENTS OR DISINFEC-
TANTS AND THE USAGE INSTRUCTIONS OF THE AUTOMATIC DEVICES
FOR WASHING AND/OR LUBRICATING THEM.
21
FONA Hygenius 17
FONA Hygenius 22
As regards textile material (or porous, in general), such as smocks, napkins, caps and other,
carefully wash and then dry them before treating them in the autoclave.
NOTE
DO NOT USE DETERGENTS WITH A HIGH CONTENT OF CHLORINE AND/
OR PHOSPHATES. DO NOT BLEACH WITH CHLORINE-BASED PRODUCTS.
THESE SUBSTANCES CAN DAMAGE THE TRAY SUPPORTS, TRAYS AND
ANY METAL INSTRUMENTS THAT MAY BE PRESENT IN THE STERILIZA-
TION CHAMBER.
ARRANGING THE Follow the instructions below for the most efficient sterilization process, preserve the material and
increase its life time.
LOAD
General notes for positioning on trays:
–– Arrange instruments made of different metals (stainless steel, tempered steel, aluminum, etc.)
on different trays or well separated from each other;
–– In the case of instruments not made of stainless steel, place a paper sterilization napkin or a
muslin cloth between the tray and the tool, avoiding direct contact between the two different
materials;
–– In any case, arrange the objects sufficiently distant from each other that they will remain so for
the entire sterilization cycle;
–– Make sure that all instruments are sterilized in an open position;
–– Position cutting instruments, (scissors, scalpels, etc.) so they can not come into contact with
OK each other during sterilization; if necessary, use a cotton or gauze cloth to isolate and protect
them;
–– Arrange recipients (glasses, cups, test tubes, etc.) resting on their side, or upended, so avoid
pooling water;
–– Do not load trays beyond their indicated limit (see Appendix A).
–– Since this value is understood to be the maximum allowed limit, it can be excessive in some
cases, so always use common sense.
–– Do not stack trays or put them in direct contact with the walls of the sterilization chamber.
OK
–– Always use the tray support provided.
–– To insert and extract trays from the sterilization chamber, always use the extractor provided.
NOTE
PLACE A CHEMICAL STERILIZATION INDICATOR ON EVERY TRAY TO IN-
DICATE THAT THE PROCESS HAS OCCURRED: THIS AVOIDS USELESSLY
REPROCESSING THE SAME LOAD OR, WORSE, USING NON-STERILIZED
MATERIAL. IF PROCESSING WRAPPED MATERIAL, PLACE THE INDICATOR
INSIDE ONE OF THE WRAPPINGS.
22
FONA Hygenius 17
FONA Hygenius 22
Notes for rubber and plastic tubing
OK – Always rinse before use with pyrogen-free water; do not dry them;
– Arrange the tubing on the tray so that their ends are not obstructed or crushed.
– Do not bend or wind them, but allow them to lie as straight as possible.
Notes for packets and packages
– Arrange packages side-by-side, suitably spaced and absolutely not piled, to avoid their co-
ming in contact with the walls of the chamber.
– Whenever it is necessary to wrap particular objects, always use suitably porous material (ste-
rilization paper, muslin napkins, etc.), closing the wrapping with autoclave adhesive tape.
OK
Notes for wrapped material
– Wrap instruments individually or, when more than one instrument are placed in the same
wrapping, make sure that they are made of the same metal;
– Seal the wrapping with adhesive tape for autoclaves or heat-sealing machines.
– Do not use staples, pins or other fasteners since they can compromise the maintenance of
sterility;
– Arrange the envelopes so as to avoid forming air pockets that obstruct the correct penetration
and removal of the steam.
OK
– Orient the envelopes so as to leave the plastic side up and the paper side down (tray side).
– In any case, check that they are correctly positioned, turning them over, if necessary.
– If possible, place the envelopes edgewise to the tray, with a suitable support.
–– Never superimpose envelopes on top of each other.
WARNING
WHENEVER YOU ANTICIPATE PROLONGED STORAGE, ALWAYS WRAP
THE INSTRUMENTS. SEE THE CHAPTER, “PRESERVING STERILIZED MA-
TERIAL”.
Program selection is fundamental for a successful sterilization process.
Since each instrument, or material in general, has different shape, consistency and properties, it
is important to identify the most suitable program for it, both for preserving its physical cha-
racteristics (avoiding or, at any rate, limiting alterations) as well to guarantee the most effective
sterilization.
A guide to selection of the program suited to the load is given in the Appendix Programs.
23
FONA Hygenius 17
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STERILIZATION A sterilization cycle consists of a determined number of phases. The number and duration of the
phases can differ for the programs, based on the type of air extraction, sterilization process and
CYCLES drying method.
The electronic control system monitors the various phases, at the same time checking that the
various parameters are respected; if any type of anomaly is encountered during the cycle, the
program is immediately interrupted, generating an alarm identified by a code, with a relative mes-
sage explaining the nature of the problem.
With this type of control, when you select a suitable sterilization program, you are guaranteed
perfect sterilization under any conditions.
After inserting the load in the sterilization chamber (taking the precautions described in the sec-
tion “Preparing the material to be sterilized”) , select the desired sterilization cycle as follows:
11/04/13 10:54
CLOSER TO YOU
OK
134°C Universal B
121°C Universal B
CLOSER TO YOU
OK
24
FONA Hygenius 17
FONA Hygenius 22
USER-DEFINED CYCLE
To set the parameters, select the following option and confirm.
134°C Prion B
User-defined
CLOSER TO YOU
OK
Select the field to be set using the arrows and confirm with OK.
User-defined
6’ 134°C
CLOSER TO YOU 53’ 2.12 Bar
Fractionated vacuum Yes

Temperature 134°C
Process Time 6’
CLOSER TO YOU
Drying Time 4’
OK
Fractionated vacuum Yes

Temperature 134°C
Process Time 6’
CLOSER TO YOU
Drying Time 4’
OK
Press the EXIT button to save all the settings and go back to the previous page.
User-defined
6’ 134°C
Press to start the user-defined cycle.
25
FONA Hygenius 17
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EXTRA DRYING Select the EXTRA DRYING option by tapping the button indicated.
Act on the + and – buttons to set the time and confirm.
After confirmation, the extra drying time will appear next to the total cycle time.
The extra time stays in memory. To activate the extra drying function, press the OK button.
134°C Universal B 41523

4’ 134°C
Drying Time
0 min
CLOSER TO YOU
OK
Drying Time
30 min
CLOSER TO YOU
OK
134°C Universal B
4’ 134°C
CLOSER TO YOU 49’+30’ 2.12 Bar
26
FONA Hygenius 17
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RUNNING THE CYCLE Press the OK button to start the cycle with the active options selected.
Taking as example the most complete and significant sterilization cycle, i.e. the 134°C UNIVER-
SAL program, characterised by fractionated pre-vacuum, the cycle sequence is as follows:
WARMING UP
134°C Univ. 134°C
Warming up 2.12 Bar

CLOSER TO YOU
39:00 4’
FIRST VACUUM PHASE

FIRST PRESSURE RISE
SECOND VACUUM PHASE
5SECOND PRESSURE RISE
THIRD VACUUM PHASE
THIRD PRESSURE RISE
STERILIZATION
STEAM DISCHARGE
DRYING
VENTILATION
CYCLE COMPLETION
134°C Univ. 60°C
Completed 1.12 Bar
00:00
CLOSER TO YOU
0’
RESULT OF If the message "COMPLETED" appears, it means that the cycle has completed correctly without
any interruptions for alarms and that complete asepsis of the material is guaranteed.
THE CYCLE
DOOR OPENING To open the sterilizer door, press the button shown in the figure:
AT CYCLE END
134°C Univ. 60°C
Completed 1.12 Bar

CLOSER TO YOU
00:00 0’
27
FONA Hygenius 17
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MATERIAL STORAGE The sterilized material must be adequately treated and stored to maintain its sterility over time,
until its use.
Inadequate storage can cause rapid recontamination.
This leads to problems regardless of what you do since you will either be using recontaminated
material (most of the time unconsciously), placing the user and patient at risk, or you will have to
run the sterilization cycle again, with an inevitable waste of time and resources.
For this reason, we think it will be useful to provide several basic suggestions, leaving the opera-
tor the task of further study of specific texts.
Assuming that the sterilizer is located in a clean place, free of dust and not too damp, the following
precautions should be taken when handling and/or carrying sterile material:
1. Remove the load from the sterilization chamber wearing gloves and a clean, or even better,
sterilized smock. As an additional precaution, wear a protective mask on your face;
2. Rest the tray on a dry, suitably clean and disinfected surface. Take care to distance or, at any
rate, separate the sterile material from the area where contaminated material is kept waiting
to be sterilized;
3. Touch the material and/or instruments as little as possible, taking extreme care not to cut or
damage the wrappings;
4. Let the instruments cool before any transport (and subsequent storage). If necessary for
transport, transfer the material using dry, clean and disinfected containers. The containers
must be closed or, if open, covered with clean cloths.
Sterile material waiting for used must be stored using the appropriate techniques. These will
significantly slow recontamination:
1. Store the material and/or instruments in the protective wrappings that were used during
sterilization. Do not wrap the instruments after sterilization since, in addition to being useless
and completely senseless, is also potentially damaging;
2. Store the material in a dry, suitably clean and disinfected place, far from the area where
infected material passes. If possible, use closed compartments equipped with ultraviolet light;
3. Identify the sterile material by attaching the sterilization data (attaching a copy of the printed
report or an adhesive label);
4. First use the material that has been stored the longest (FIFO, "First In First Out"). This results
in material that is homogeneously stored, avoiding storing for too long, with the consequent
risks.
5. Never store material for too long. In fact, do not overlook the fact that materials will tend
to degrade and be recontaminated in a finite time, even when the above instructions are
followed.
NOTE
Consult the specifications provided by the manufacturer of the packaging material
relative to the maximum allowed storage time. In the absence of appropriate instructions,
do not exceed the following storage periods:
Basket with sealing ring or container without gasket 1-2 days

Container with filter and gasket or container with valves. 30 days
Single-ply “Medical Grade” paper 1-2 days
Double-ply “Medical Grade” paper (orthogonal) 30 days
Polyester / polypropylene paper covering, single 30 days
Polyester / polyproylene paper covering, double 60 days
The values indicated refer to material that has been properly stored.
NOTE
THOSE STORAGE PERIODS MIGHT VARY FROM COUNTRY TO COUNTRY, DEPEN-
DING ON THE LOCAL LEGAL REQUIREMENTS.
28
FONA Hygenius 17
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TEST PROGRAMS
To protect the safety of users and patients, a fundamental process like sterilizing medical devices
should be periodically checked.
INTRODUCTION
The the Hygenius 17 and Hygenius 22 series offer the possibility of easily and automatically
executing two distinct test cycles:
• Helix/B&D Test
• Vacuum Test
Helix/BD Test is a cycle run at 134°C characterised by a sterilization phase that lasts a specific
time (3.5 minutes); the cycle comprises the fractionated vacuum phases similar to those used in
the UNIVERSAL cycles.
Using an appropriate device, you can assess correct steam penetration into hollow loads.
The cycle is also suitable to measure steam penetration into porous loads (Bowie & Dicktest
pack).
CYCLE HELIX
TEST/B&D
11/04/13 10:54
CLOSER TO YOU
OK
Vacuum Test
Helix Test/B&D
CLOSER TO YOU
OK
Helix Test/B&D
CLOSER TO YOU
20’ -0.80 Bar
29
FONA Hygenius 17
FONA Hygenius 22
To select the Helix/B&D Test cycle, select Helix Test/B&D using the arrows and confirm with OK.
The test device (in accordance with EN 867-5 specifications) consists of a 1.5m-long PTFE tube
with an inside diameter of 2mm to whose end a small hermetically-sealed screw cap is fastened,
able to contain an appropriate chemical indicator. The other end of the tube is left free so that the
steam can penetrate and you can assess its effectiveness.
To conduct the test (with reference to EN 13060), insert the chemical indicator (consisting of a
paper strip with a special reagent ink) in the device cap (always to be used perfectly dry). Tighten
the cap in such a way that seepage through the gasket is not possible.
NOTE
THE TEST DEVICE AND THE CHEMICAL INDICATORS TO EXECUTE THE
HELIX/BD TEST CYCLE ARE NOT PROVIDED WITH THE STERILIZER. FOR
INFORMATION IN THIS REGARD, CONTACT CUSTOMER SERVICE (SEE AP-
PENDIX).
Place the device roughly in the middle of the central tray. Do not insert other material in the cham-
ber. Close the door and start the cycle.
The test cycle takes place with a succession of phases similar to those described for a normal
sterilization cycle.
At the end of the cycle, remove the test device from the chamber, open the cap and remove the
indicator from its housing.
If the steam has correctly penetrated, the ink will have completely changed its original colour
over the entire length of the strip; if not (insufficient penetration), there will only be a partial colour
change or even no change at all.
NOTE
NORMALLY, THE COLOUR CHANGES FROM A LIGHT COLOUR (BEIGE,
YELLOW, ETC.) TO A DARK COLOUR (BLUE, VIOLET OR BLACK). IN ANY
EVENT, STRICTLY FOLLOW THE INSTRUCTIONS AND ANY ADDITIONAL
TECHNICAL DETAILS PROVIDED BY THE INDICATOR MANUFACTURER.
30
FONA Hygenius 17
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CYCLE VACUUM TEST

The Vacuum Test cycle allows testing perfect seal of the sterilizer hydraulic system.
Measuring the variation of the degree of vacuum in a defined time-frame and comparing it with
pre-established limit values, you can determine how good the seal of the sterilization chamber,
tubes and the various interception devices is.
To select the Vacuum Test cycle, select Vacuum Test using the arrows and confirm with OK.
11/04/13 10:54
CLOSER TO YOU
OK
Vacuum Test
CLOSER TO YOU
Helix Test/B&D
OK
Vacuum Test
CLOSER TO YOU
20’ -0.80 Bar
Vacuum 23°C
Vuoto -0.58
11:00
CLOSER TO YOU
31
FONA Hygenius 17
FONA Hygenius 22
The Vacuum Test program is run with the sterilization chamber empty, and only the trays and
their supports.
NOTE
RUN THE VACUUM TEST AS THE FIRST CYCLE AFTER POWERING-ON THE
EQUIPMENT.
A high chamber temperature affects the variation in the vacuum value measured during the test;
the system is therefore programmed to prevent execution of the test when the operating condi-
tions are inadequate.
Close the door and start the program.
The vacuum phase starts immediately and the pressure value (bar) and the countdown from the
start of the test cycle is shown on the display.
NOTE
IF THE PRESSURE VARIATION EXCEEDS THE LIMIT DEFINED, THE PRO-
GRAM IS INTERRUPTED AND AN ALARM MESSAGE GENERATED. FOR A
COMPLETE DESCRIPTION OF THE ALARMS, REFER TO THE APPENDIX.
32
FONA Hygenius 17
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DOOR OPENING To open the autoclave door, hold down the button shown in the figure.
11/04/13 10:54
CLOSER TO YOU
OK
The door opens and stays ajar.
You can now manually open the door.
33
FONA Hygenius 17
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USED WATER DRAIN Open the door and continue as follows:
1. Prepare a basin with a capacity of at least 4 litres in proximity of the sterilizer; place the free
end of the drain tube provided in the basin.
2. Insert the other end of the tube in the female union beneath the chamber inlet (connector on
the right) pushing down until you hear a click.
3. Completely empty out the tank and then press on the metal lever of the union and detach the
tube quick-coupling.
Detaching the pipe
34
FONA Hygenius 17
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MANUAL The cycle can be interrupted manually by the operator at any time by holding down the button
INTERRUPTION shown in the figure for three seconds.
134°C Univ. 134°C
Warming up 2.12 Bar

CLOSER TO YOU
39:00 4’
>3 s
The command generates the error E999 as the cycle could not be completed correctly.
NOTE
IF THE CYCLE IS INTERRUPTED DURING CERTAIN PHASES, AN AUTO-
MATIC CLEANING PROCEDURE OF THE INTERNAL HYDRAULIC CIRCUIT
STARTS.
FOR A COMPLETE DESCRIPTION OF THE ALARMS, REFER TO THE AP-
PENDIX "ALARM INDICATIONS".
WARNING
AFTER MANUALLY INTERRUPTING A PROGRAM, DO NOT USE THE LOAD,
AS STERILIZATION IS NOT GUARANTEED.
35
FONA Hygenius 17
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DATA MANAGEMENT To access the DATA MANAGEMENT section, select the following icon and press the OK button.
11/04/13 10:54
CLOSER TO YOU
OK
PRINT MANAGEMENT
To set the parameters, select the following option and confirm with OK.
Print management
USB management
CLOSER TO YOU
OK
Select Print last cycle to choose between printing the Report or the Extended report.
Paper setting
CLOSER TO YOU
Print last cycle
OK
Press ok to select paper type and go back to the previous menu. The cursor is placed on the
previously selected paper.
Labels
Report
CLOSER TO YOU
OK
36
FONA Hygenius 17
FONA Hygenius 22
134°C Univ. 60°C
Completed 1.12 Bar

CLOSER TO YOU
00:00 0’
At the end of the cycle, press the button indicated to print the report.
Paper setting
CLOSER TO YOU
Print last cycle
OK
Labels
Report
CLOSER TO YOU
OK
Selecting the PRINT LAST CYCLE option with the REPORT option set, the summary report of the
last cycle is printed, otherwise you go back to the PAPER SETTING page.
Set the REPORT option and carry out the above described operations again.
Selecting the PRINT TECHNICAL REPORT option, the technical report is printed (only if the
REPORT option is set).
37
FONA Hygenius 17
FONA Hygenius 22
DOWNLOAD CYCLE DATA
Before carrying out the following operations, insert the USB key.
Selecting CYCLE DATA DOWNLOAD, you can copy the data relating to the cycles executed (sto-
red in the internal memory of the sterilizer) to the USB key.
Print management
Downl. cycle data

System information
CLOSER TO YOU
OK
NOTE
The USB key must be formatted using the FAT32 file system.
You can select the number of cycles to download to the external memory.
New
Last 10
Last 50
CLOSER TO YOU
OK
If the USB key is not present, you are asked to insert it.
The sterilization/test cycle files are in PDF format.
Insert key
CLOSER TO YOU
Download in progress... Download completed

Remove key
CLOSER TO YOU
CLOSER TO YOU
Once the data has been downloaded, you can remove the USB key.
38
FONA Hygenius 17
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SYSTEM INFORMATION
Selecting SYSTEM INFORMATION, all the information relating to the sterilizer settings is displa-
yed.
Print last cycle
System information
CLOSER TO YOU
OK
Autoclave code:
FW version:
Serial number:
Language:
CLOSER TO YOU
39
FONA Hygenius 17
FONA Hygenius 22
APPENDIX – TECHNICAL CHARACTERISTICS
SUMMARY TABLE
Device Steam Sterilizer
Classification (according to
the Directive 93/42/EEC and Hygenius 17 Hygenius 22
subsequent changes)
Model II b
FONA s.r.l.
Manufacturer Via Galileo Galilei, 11
20090 Assago (MI) Italy
220 V - 240 V~ 50 Hz
Power supply voltage
220 V - 230 V~ 60 Hz
Mains fuses
F 15A 250V
(6.3 x 32 mm)
On-board fuses F1: T3.15A 250V (primary transformer)
(5 x 20 mm) F2: T 3.15A 250V (vacuum pump)
Nominal power 2300 W (10A)
Insulation class Classe I
Installation category Cat. II
Environment of use Internal use
Sound power level (A

< 65 db(A)
weighted)
Temperature: +15°C ÷ +35°C
Environmental operating
Relative humidity: max 80%, non-condensing
conditions
Altitude: max 3000 m (a.s.l.)
External dimensions (HxWxD)
420 x 480x 560 mm 420 x 480x 660 mm
(excluding rear connections)
Net weight:
empty about 53 kg about 60 kg
empty with trays and supporti about 54 kg about 62 kg
empty, with trays and supports
and water at MAX level about 58 kg about 66 kg
Sterilization chamber
250 x 350 mm 250 x 450 mm
dimensions (Ø x D)
Sterilization chamber total

about 17 l (0.017 m3) about 22 l (0.022 m3)
volume
Sterilization chamber useful
volume about 10 l (0.010 m3) about 13 l (0.013 m3)
(with tray supports inserted)
Distilled water tank capacity ca. 4,6 l (water at MAX level)

(supply) ca. 0,8 l (water at MIN level)
Sterilization programs 5 standard programs + 1 user-defined program
Helix/BD Test
Test programs
Vacuum Test
Preheating time
about 10 min
(from cold)
USB connection requires memories formatted with the FAT32 file system
Printer connection RS232 serial (printer cable length max 2.5 m)
Bacteriological filter Porosity: 0,2 mm

(PTFE filtering element) Connection: 1/8” NPT connector
40
FONA Hygenius 17
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SAFETY DEVICES
The sterilizer is equipped with the following safety devices for which we provide a brief description of their function:
–– Mains fuses (see summary table data)

Protection inside the device against a fault in the heating elements.
Action: cuts the electricity.
–– Fuses protecting the electronic circuits (see summary table data)

Protection against a fault in the primary transformer circuit and low voltage uses.
Action: cuts power to one or more low-voltage circuits.
–– Thermal circuit breakers on the mains voltage windings

Protection against overheating of the vacuum pump motor and the primary transformer windings.
Action: temporary cut-off (until cooling) of the winding.
–– Safety valve
Protection against overpressure in the sterilization chamber.
Action: release of the steam and restoration of the safety pressure.
–– Steam generator manual rearm safety thermostat

Protection against steam generator overheating.
Action: cut-off of the electricity to the steam generator.
–– Heating element manual rearm safety thermostat

Protection against overheating of the heating elements of the container under pressure.
Action: cut-off of the electricity to the chamber heating element.
–– Door position safety microswitch

Confirmation of the correct closing position of the door of the container under pressure.
Action: signals wrong door position.
–– Mechanized door lock mechanism with electromechanical protection (pressure switch)

Protection against accidental opening of the door (even in a blackout).
Action: prevents accidental opening of the door during a program.
–– Door lock mechanism safety microswitch

Confirmation of the correct closing of the door lock.
Action: signaling the failure or incorrect operation of the door lock mechanism.
–– Self-leveling plumbing system

Plumbing system structure for the spontaneous leveling of the pressure in the case of a manual interruption of the cycle,
alarm or blackout.
Action: automatic restoration of atmospheric pressure in the sterilization chamber.
–– Integrated system for evaluating the sterilization process

Continuous verification of the sterilization process parameters entirely managed by microprocessor.
Action: immediate interruption of the program (in case of anomaly) and generation of alarms.
–– Monitoring of the sterilizer’s operation

Real-time oversight of all significant parameters when the machine is powered.
Action: generation of alarm messages (in the case of anomaly) with possible interruption of the cycle.
41
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WATER SUPPLY CHARACTERISTICS
VALUES IN
DESCRIPTION WATER SUPPLY VALUES
CONDENSATE
DRY RESIDUE < 10 mg/l < 1 mg/l
SILICON OXIDE SiO2 < 1 mg/l < 0.1 mg/l
IRON < 0.2 mg/l < 0.1 mg/l
CADMIUM < 0.005 mg/l < 0.005 mg/l
LEAD < 0.05 mg/l < 0.05 mg/l

HEAVY METAL RESIDUES
< 0.1 mg/l < 0.1 mg/l
(except iron, cadmium and lead)
CHLORINES < 2 mg/l < 0.1 mg/l
PHOSPHATES < 0.5 mg/l < 0.1 mg/l
CONDUCTIVITY AT 20 °C < 15 ms/cm < 3 ms/cm
pH VALUE 5-7 5-7

colorless, transparent, colorless, transparent,
APPEARANCE
without sediments without sediments
HARDNESS < 0.02 mmol/l < 0.02 mmol/l
NOTE
WHEN PURCHASING DISTILLED WATER, ALWAYS CHECK THAT THE QUALITY AND
CHARACTERISTICS DECLARED BY THE PRODUCER ARE COMPATIBLE WITH THOSE
SHOWN IN THE TABLE.
WARNING
THE USE OF WATER FOR GENERATING STEAM CONTAINING CONTAMINANTS IN
LEVELS EXCEEDING THOSE SHOWN IN THE TABLE WILL SIGNIFICANTLY SHORTEN THE
STERILIZER’S LIFE.
IN ADDITION, THIS MAY INCREASE THE OXIDATION OF MORE SENSITIVE MATERIALS AND
INCREASE LIME RESIDUES ON THE GENERATOR, BOILER, INTERNAL SUPPORTS AND
INSTRUMENTS.
42
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APPENDIX – PROGRAMS
INTRODUCTION
The steam sterilizer is appropriate for almost all materials and instruments, so long as they are able to tolerate, without damage,
a minimum temperature of 121 °C (otherwise, you will need to use other low-temperature sterilization systems).
The following material can normally be sterilized with steam:
– Stainless steel surgical/generic instruments;

– Carbon steel surgical/generic instruments;
– Rotating and/or vibrating instruments driven by compressed air (turbines) or mechanical transmission (counter-angles, tooth
scalers);
– Glass articles:
– Mineral-based articles;
– Articles made of heat-resistant plastic;
– Articles made of heat-resistant rubber;
– Heat-resistant textiles;
– Medication materials (gauze, pads, etc.);
– Other generic material suitable for autoclave treatment.
NOTE
DEPENDING ON THE CONFORMATION OF THE MATERIAL (SOLID, HOLLOW OR POROUS),
ANY PACKAGING (PAPER/PLASTIC ENVELOPE, STERILIZATION PAPER, CONTAINER,
MUSLIN NAPKIN, ETC.) AND ITS HEAT-RESISTANCE, IT IS INDISPENSABLE THAT YOU
CHOOSE THE APPROPRIATE PROGRAM BY REFERRING TO THE TABLE SHOWN ON THE
NEXT PAGE.
WARNING
THE DEVICE MAY NOT BE USED FOR STERILIZATION OF FLUIDS, LIQUIDS OR
PHARMACEUTICAL PRODUCTS.
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PROGRAM SUMMARY TABLE – 17
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS
PARAMETERS
Average H2O consumption

(F=fractionated; S=Single)
(average load ÷ max load)

Cycle time (EN 13060
MAX TOTAL WEIGHT

Average energy con-
(L=long; C=short)
Standard drying
Total cycle time
FOR TRAY (kg)

Retention time
FOR ITEM (kg)

MAX WEIGHT
MAX WEIGHT
DESCRIPTION
Temperature
(kWh /cycle)
Pre-vacuum
(ml /cycle)
NOTES
sumption
Pressure
CYCLE
(min)
(bar)
(kg)
(°C)
TYPE
Unwrapped porous
1.00 0.30 0.30
materials
Porous materials in sin-

0.75 0.25 0.25
gle package
Porous materials in
0.60 0.20 0.20
double package
134°C UNIVERSAL 134 2.10 4 B F L 37÷40 500 0.8
Solid and hollow mate-
3.00 1.00 0.25
rials in single package
Unwrapped solid and

6.00 1.20 0.50
hollow materials
Solid and hollow in-
struments A" in double 1.50 0.50 0.25
package
Unwrapped porous
1.00 0.30 0.30
materials

0.75 0.25 0.25
gle package
Porous materials in For wrapped materials

0.60 0.20 0.20 and instruments (single
double package
134°C PRION 134 2.10 >18 B F L 53÷56 550 0.9 and double package), it
Hollow instruments in is advisable to use the
3.00 1.00 0.25
single package 3-tray configuration
Unwrapped solid and
6.00 1.20 0.50
hollow materials
struments in double 1.50 0.50 0.25
package
Unwrapped porous
1.00 0.30 0.30
materials

0.75 0.25 0.25
gle package
Porous materials in
0.60 0.20 0.20
double package
121°C UNIVERSAL 121 1.10 20 B F L 52÷55 550 0.8
Unwrapped solid and
6.00 1.20 0.50
hollow materials
Hollow instruments in
3.00 1.00 0.25
single package
package
Unwrapped hollow in-
7,50 1,50 0.50
134°C HOLLOW struments
121 1,10 20 S F C 34÷37 700 0.7
UNWRAPPED Unwrapped solid and
7,50 1.20 0.50
hollow materials
It is advisable to use the
struments "B" in single 3.00 1.00 0.25
3-tray configuration
S 134°C FLASH 134 2.10 4 S S L 33÷36 300 0.6 package
Unwrapped solid and
6.00 1.20 0.50
hollow materials
Unwrapped solid instru-
134 2.10 >4 Variable parameters de-
XXX°C USER ments (other load types are
or or or. n.a. F/S L/C n.a. n.a. n.a. n.a. n.a. n.a. pending on the settings
(see note) possible depending on the
121 1.10 >20 made
user settings)
Test device only
HELIX/BD TEST 134 2.10 3.5 - F C 29 - - - - -
(without another load)
VACUUM TEST - -0,80 - - - - 27 - - Empty chamber - - -
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PROGRAM SUMMARY TABLE – 22

BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS
PARAMETERS
Average H2O consumption

(F=fractionated; S=Single)
(average load ÷ max load)

Cycle time (EN 13060)
MAX TOTAL WEIGHT

Average energy con-
(L=long; C=short)
Standard drying
Total cycle time
FOR TRAY (kg)

Retention time
FOR ITEM (kg)

MAX WEIGHT
MAX WEIGHT
DESCRIPTION Temperature
(kWh /cycle)
Pre-vacuum
(ml /cycle)
NOTES
sumption
Pressure
CYCLE
(min)
(bar)
(kg)
(°C)
TYPE
Unwrapped porous
1.25 0.40 0.30
materials
1.00 0.30 0.25
gle package
Porous materials in
0.75 0.25 0.20
double package
134°C UNIVERSAL 134 2.10 4 B F L 40÷43 675 0.8
Solid and hollow mate-
4.00 1.25 0.25
rials in single package
Unwrapped solid and
7.50 1.20 0.50
hollow materials
struments A in double 2.00 0.60 0.25
package
Unwrapped porous
1.25 0.40 0.30
materials
1.00 0.30 0.25
gle package
Porous materials in For wrapped materials
0.75 0.25 0.20 and instruments (single
double package
134°C Prion 134 2.10 >18 B F L 57÷60 700 0.9 and double package), it
Hollow instruments in is advisable to use the
4.00 1.25 0.25
single package 3-tray configuration
Unwrapped solid and
7.50 1.20 0.50
hollow materials
package
Unwrapped porous
1.25 0.40 0.30
materials
1.00 0.30 0.25
gle package
Porous materials in
0.75 0.25 0.20
double package
121°C UNIVERSAL 121 1.10 20 B F L 55÷58 700 0.8
Hollow instruments in
4.00 1.25 0.25
single package
Unwrapped solid and
7.50 1.20 0.50
hollow materials
package
Unwrapped hollow in-
7.50 1.50 0.50
134°C HOLLOW UN- struments
121 1.10 20 S F C 34÷37 700 0.7
WRAPPED Unwrapped solid and
7.50 1.20 0.50
hollow materials
struments "B" in single 4.00 1.25 0.25
It is advisable to use
S 134°C FLASH 134 2.10 4 S S L 31÷33 375 0.6 package
Unwrapped solid and the 3-tray configuration
7.50 1.20 0.50
hollow materials
Unwrapped solid instru-
134 2.10 >4 Variable parameters
XXX°C USER ments (other load types
or or or. n.a. F/S L/C n.a. n.a. n.a. n.a. n.a. n.a. depending on the set-
(see note) are possible depending
121 1.10 >20 tings made
on the user settings)
Test device only

HELIX/BD TEST 134 2.10 3.5 - F C 31 - - - - -
(without another load)
VACUUM TEST - -0,80 - - - - 29 - - Empty chamber - - -
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STERILIZATION PROGRAM DIAGRAM
Pressure (bar)
PROGRAM
134°C - UNIVERSAL
PROCESS
134°C - 4' 00''
2.10
2.00 PROGRAM
134°C - PRION
134°C - 18' 00''
1.00
Time (min)
0.00
-0.80
PRE-VACUUM LONG DRYING
Pressure (bar)
PROGRAM
121°C - UNIVERSAL
121°C - 20'00''
PROCESS
1.10
1.00
Time (min)
0.00
-0.80
LONG DRYING
FRACTIONATED PRE-VACUUM
46
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Pressure (bar)
PROGRAM
PROCESS S 134°C FLASH
134°C - 4'00''
2.10
2.00
1.00
Time (min)
0.00
-1.00
ONE SHOT PRE-VACUUM LONG DRYING
Pressure (bar)
PROGRAM
S
S 134°C
134°CFLASH
FLASH
PROCESS
134°C
134°C -- HOLLOW
4'00'' (UNWRAPP.)
2.10
2.00
1.00
Time (min)
0.00
-1.00
ONE SHOT PRE-VACUUM LONG DRYING
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DIAGRAMS OF THE TEST PROGRAMMES
Pressure (bar) PROGRAM

BOWIE & DICK TEST
PROCESS 134°C - 3'00''
2.10
2.00
1.00
Time (min)
0.00
0.00
- 1.00 SHORT DRYING
FRACTIONATED PRE-VACUUM
Pressure (bar) PROGRAM

VACUUM TEST (VT)
-0.80 bar
1.00
Intermediate condition for End condition for

the continuation of the test positive test result
0.00 t1 (P2-P1) < (P0-P1) /10 t2 = t1+300 s (P3-P2) < 0.013

0.02 bar t3 = t2+600 s Time (min)
P 0
5 minutes 10
16 minutes
minutes
VACUUM
PHASE
WAITING LEAKAGE
-0.80 P2 P3
P1
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EXAMPLES OF PRINTED REPORTS

(WITH OPTIONAL PRINTER)
Program printing (standard) Program printing Program printing

HELIX/BD TEST VACUUM TEST
Model Model
S/N S/N
Ver. SW Ver. SW
Counter 0007/0015 Model
Counter 0011/0019
Selection 134 °C SOLID S/N
Selection VACUUM TEST
Temperature 134 °C Ver. SW
Pressure 2.10 bar Counter 0011/0019
Process time 4 min Selection HELIX TEST
Stand‑by LOW CYCLE START 01/02/11
Temperature 134 °C
Pre-vacuum SINGLE 11:37
Pressure 2.10 bar
Drying FAST Process time 3.5 min
Time C bar
CYCLE START 01/02/11
CYCLE START 01/02/11 ----------------------------------------------------------
16:38
12:14 00:00 CS 035.0 +0.00
Time C bar
Time C bar 01:39 E1F 037.4 ‑0.80
---------------------------------------------------------- ----------------------------------------------------------
00:01 CS 079.4 +0.00 00:01 CS 076.4 +0.00
02:06 1PV 089.3 -0.89 6:39 E2F 038.4 ‑0.79
02:02 1PV 093.7 -0.80
05:48 ET 135.6 +2.15 04:35 1PP 120.4 +0.99
05:45 2PV 062.5 -0.78 22:39 E3F 042.0 ‑0.79
06:02 SS 135.9 +2.17
07:02 135.6 +2.14 07:02 2PP 120.2 +0.97
08:02 135.5 +2.14 08:15 3PV 061.1 -0.79 23:54 CE 045.5 ‑0.01
09:02 135.4 +2.14 11:00 .. 135.6 +2.15
10:02 SE 135.5 +2.15 11:14 .. 136.0 +2.17 CYCLE END 01/02/11
10:37 DS 104.1 +0.00 12:14 135.6 +2.14 12:01
11:41 SPD 047.5 ‑0.90 13:14 135.6 +2.15
16:08 DE 047.6 ‑0.84 14:14 135.5 +2.14 VACUUM TEST: POSITIVE
17:12 CE 084.6 ‑0.04
14:45 .. 135.4 +2.14
OPERATOR
06:32 MAX 136.0 15:20 .. 111.5 +0.00
..................................
09:59 MIN 135.4 16:34 … 047.8 -0.89
18:21 … 059.5 -0.86
Drying PuIses 01 19:21 .. 075.4 ‑0.50
CYCLE END 01/02/11 20:06 CE 078.7 ‑0.04
12:36
12:33 MAX 136.0
STERILIZATION: POSITIVE 14:44 MIN 135.4
Drying pulses 01
CYCLE END 01/02/11
17:01
Model
S/N HELIX TEST COMPLETE
Ver. SW Please attach the indicator hereunder
Counter 0007/0015
Selection 134 °C UNIVERSAL
Temperature 134 °C
Pressure 2.10 bar
Process time 4 min
Stand-by HIGH
Pre-vacuum FRACTIONATED
Drying STANDARD
CYCLE START 01/02/10

09:52
Time C bar
----------------------------------------------------------
00:01 CS 075.1 ‑0.00
01:57 1PV 047.S ‑0.80
04:53 1PP 120.5 +1.00
07:00 2PV 061.1 ‑0.80
09:15 2PP 120.4 +0.98
11:22 3PV 061.1 ‑0.80
15:04 ET 135.5 +2.15
15:19 SS 135.9 +2.17
16:19 135.4 +2.14
17:18 135.5 +2.15
18:19 135.4 +2.14
19:19 SE 135.5 +2.15
19:53 DS 104.4 +0.00
20:57 SPD 048.4 ‑0.90
26:55 EPD 094.9 ‑0.86
29:15 DE 112.6 ‑0.47
29:43 CE 115.8 ‑0.04
16:20 MAX 135.9

18:11 MIN 135.4
Drying Pulses 05
CYCLE END 01/02/11
10:28
STERILIZATION: POSITIVE
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APPENDIX – MAINTENANCE
In addition to correct use, the user needs to perform ordinary maintenance in order to guarantee safe, efficient operation over the
device’s entire life.
For better quality maintenance, supplement ordinary checks with regular periodic examinations
INTRODUCTION by the service department (see Appendix).
It is also fundamental to perform a periodic sterilizer validation, i.e., a check of the

thermodynamic parameters of the process, comparing them with the reference values provided
with suitably calibrated instruments. In this regard, see the paragraph, “Periodic Sterilizer’s
Validation”, further below in this Appendix.
The ordinary maintenance described below consists in easy manual operations and preventive
interventions involving simple instruments.
WARNING
IN THE EVENT OF THE REPLACEMENT OF THE DEVICE’S COMPONENTS
OR PARTS, REQUEST AND/OR USE ORIGINAL REPLACEMENT PARTS
ONLY.
ORDINARY The table summarizes the maintenance required to keep the sterilizer operating at peak
MAINTENANCE efficiency. In the case of very intense use, we recommend shortening maintenance intervals:
PROGRAM
Clean the gasket on the porthole
DAILY
Clean external surfaces
Clean the sterilization chamber and relative accessories

WEEKLY
Disinfect external surfaces
Clean the internal (and external - if installed) distilled water

tank
MONTHLY
Safety valve maintenance
Clean (or replace) the drain filter
ANNUALLY Validate sterilizer (see dedicated paragraph)
Scheduled Maintenance The steriliser periodically reminds the user about necessary “routine” maintenance operations
Messages that must be carried out in order to ensure the proper operation of the device.
Message
Replace the bacteriological filter

CLOSER TO YOU
OK
Press the OK button to confirm that the required maintenance operation has been completed.
Press the button to postpone the operation.

In this case, the warning message will reappear the next time the sterilizer is used..
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NOTE
The user is given warning messages with the following frequency:
WARNING MESSAGES FREQUENCY

BOILER FILTER CLEANING Every 250 cycles
BACTERIOLOGICAL FILTER
Every 500 cycles
REPLACEMENT
BOILER GASKET REPLACEMENT Every 1.000 cycles
GENERAL SERVICE Every 3.000 cycles
Whenever significant reductions in performance, repeat alarms or a visible deterioration of parts

subject to wear is noted, it is recommended that maintenance operations be carried out in advan-
ce of the deadlines programmed in the system.
Keep the following general warnings in mind:
–– Do not wash the sterilizer with direct jets of water, either under pressure or sprinkled. Seepage
into electrical and electronic components could damage the functioning of the device or its
internal parts, even irreparably;
–– Do not use abrasive cloths, metal brushes (or other aggressive materials) or metal-cleaning
products, whether solids or liquids, to clean the device or sterilization chamber;
–– Do not use chemical products or disinfectants to clean the sterilization chamber. In fact, these
products can damage the sterilization chamber, even irreparably;
–– Do not allow lime residue or other substances to accumulate in the sterilization chamber or
on the door and its gasket, but periodically remove them. In fact, they can damage these parts
over time in addition to compromising the operation of the components installed along the
plumbing circuit.
NOTE
THE FORMATION OF WHITE SPOTS ON THE BASE OF THE INTERNAL
WALLS OF THE STERILIZATION CHAMBER MEANS THAT YOU ARE USING
LOW-QUALITY DEMINERALIZED WATER.
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DANGER
BEFORE PERFORMING ORDINARY MAINTENANCE, MAKE SURE THAT THE
POWER SUPPLY CORD IS REMOVED FROM THE MAINS SOCKET.
WHENEVER IT IS NOT POSSIBLE, PUT IN OFF THE EXTERNAL BREAKER

OF THE EQUIPMENT POWER SUPPLY LINE.
IF THE EXTERNAL BREAKER IS FAR AWAY OR, AT ANY RATE, NOT VISIBLE
TO THE MAINTAINER, PLACE A WORK IN PROGRESS SIGN ON THE
EXTERNAL BREAKER AFTER TURNING IT OFF.
MAINTENANCE Let’s now look at the various operations to be carried out.

DESCRIPTION
Clean gasket and porthole To eliminate any traces of limestone, clean the chamber gasket and the door window with a
clean cotton cloth that has been soaked in a weak solution of water and vinegar (or a similar
product; verify the contents on the label before using).
Dry the surfaces and remove any residues before using the device.
Clean external surfaces Clean all the external parts using a clean cotton cloth dampened with water and, possibly,
the addition of a neutral detergent.
Dry the surfaces and remove any residue before using the device.
Clean sterilization chamber Clean the sterilization chamber, support and trays (and internal surfaces in general) with a
and accessories clean cotton cloth soaked in water and, possibly, the addition of a small amount of neutral
detergent.
Carefully rinse with distilled water, taking care not to leave any type of residue in the chamber
or on accessories.
NOTE
DO NOT USE POINTED OR SHARP TOOLS TO REMOVE SCALE FROM THE
STERILIZATION CHAMBER. SHOULD THERE BE EVIDENT DEPOSITS, IM-
MEDIATELY CHECK THE QUALITY OF THE DISTILLED WATER USED (SEE
APPENDIX TECHNICAL FEATURES).
Disinfect external surfaces For the occasional disinfection of the external surfaces, you can use either denatured alcohol
or detergents with a minimum percentage of sodium hypochlorite (or equivalent).
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Boiler filter cleaning With use it is likely that various residues accumulate in the filter and with time obstruct the lower
drain duct.
To clean the filter, open the sterilizer door and remove the cap using a coin or another suitable
tool.
Then unscrew the union containing the filter.
Remove the filter from its holder and thoroughly clean it under a jet of running water, if necessary
using a sharp tool to remove any large foreign bodies (if possible use a jet of compressed air).
If it is impossible to recover the filter, replace it with a new one.
Refit everything operating in reverse order from removal and making sure that you screw the
union on in such a way that the drain holes are positioned at the level of the boiler wall.
NOTE
PROPERLY FIT THE FILTER IN ITS HOUSING; FITTING IT ONLY PARTIALLY
MAY DAMAGE THE COMPONENT.
Replace the bacteriological When filter maintenance is due according to the maintenance schedule or every time you notice
filter visible clogging of the filter (indicated by the filter markedly turning grey), unscrew the bacterio-
logical filter (B) from its holder and replace it with a new one, screwing it fully down on the union.
NOTE
A SPARE BACTERIOLOGICAL FILTER IS PROVIDED WITH THE STERILIZER.
TO ORDER FURTHER FILTERS, REFER TO THE APPENDIX TECHNICAL
SERVICE.
Boiler gasket replacement It is advisable to have the boiler gasket replaced by an authorised technician, therefore, contact
Technical Service (see APPENDIX – TECHNICAL SERVICE).
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PERIODIC STERILIZER As happens with all equipment, it is possible, and sometimes inevitable, to have a decrease in
VALIDATION performance and the effectiveness of components along its lifespan, in a period of time dependent
on its frequency of use.
To guarantee the safety of the process over time, it is periodically (possibly annually) necessary
to verify the thermodynamic process parameters (pressure and temperature), to check if they
continue to remain within allowed limits or not.
The requalification of the sterilizer’s performance is the responsibility of the user of the product.
The reference European standards EN 17665 (Sterilization of the medical devices - Method for
the validation and systematic control of the steam sterilization) and EN 556 (Sterilization of the
medical devices – Requirements for the medical devices marked with “STERILE” indication)
supply an effective guide tool for carrying out the verifications on the steam sterilizers.
Since, in addition to specific experience and training, these controls require the use of special
equipment (high-precision sensors and probes, data loggers, dedicated software, etc.) suitably
verified and calibrated, it is necessary to contact a company specializing in these activities.
Customer support department (see Appendix is available to provide any information relative to
the periodic validation of steam sterilizers.
DISPOSAL AT In accordance with Directives 2002/95/ EC, 2002/96/ EC and 2003/108/ EC, regarding the
END-OF-LIFE reduction in use of dangerous substances in electrical and electronic equipment, as well as waste
disposal, such equipment may not be disposed of as normal urban waste and must be separated
accordingly. When purchasing a new, equivalent piece of equipment, the old piece of equipment
that has reached its end-of-life must be handed over to the reseller for proper disposal. As regards
reuse, recycling and other forms of recovery of the above mentioned waste, the manufacturer
carries out the functions defined in the individual national legislations.
The proper collection and separation of such equipment for recycling, treatment and disposal helps
avoid any possible negative effects on the environment and health and facilitates the recycling of
the materials of which the equipment is made. The crossed out rubbish can symbol indicates that
the product, at the end-of-life, must be collected separately from other types of waste.
WARNING!
Improper disposal of the product results in the application of sanctions which are defined
by individual national laws.
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APPENDIX – GENERAL PROBLEMS

INTRODUCTION
If you run into a problem or alarm while using the device, you should not be immediately concerned.
It may not, in fact, be related to a breakdown but, more probably to an anomalous situation, often merely transitory (such as a
blackout), or incorrect use.
In any case, it is important to first identify the cause of the anomaly and then take suitable corrective action, either autonomously or
with the help of the Technical Support Department (see Appendix Z).
For this purpose, below, we provide instructions for diagnosing and resolving general problems, in addition to a precise description of
the alarm codes, their meaning and their solution.
ANALYSIS AND RESOLUTION OF PROBLEMS

If your sterilizer is not working correctly, please make the following checks before calling the Technical Support Department:
PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION
The power cord is not plugged-in. Plug it in.
Check the cause of the lack of voltage at and

There is no voltage at the socket.
socket and fix it.
The sterilizer does not power-on. The main switch and/or differential
Turn the switch ON.
switch are OFF.
Replace with good fuses of equal nominal
value.
The mains fuses are blown.
(See the Summary Table in Appendix
Technical Characteristics).
Wait for the sterilizer to reach the proper

operating conditions for starting the program.
After pressing START, the sterilization
The device is preheating. NOTE: Under normal conditions, the
cycle does not start.
average preheating time is about
10-15 minutes.
Check that the knurled locking ring is cor-

rectly tightened on the upper part of safety
valve.
DANGER
Locking ring loosened.
LET THE DEVICE
The safety valve has intervened. Presence of anomalous overpressure in COOL, OR WEAR
the chamber. GLOVES TO AVOID
BEING BURNED
WHEN TOUCHING
THE VALVE.
.
Check the seal of the unions; if necessary,
refit paying greater attention.
Automatic water filling system tube (op-
tional) not properly connected. Check that the tubes are completely fitted on
the unions; check that the hose clamps are
There is water on the support surface of fitted.
the sterilizer.
At the end of the cycle, clean the gasket and
porthole of the container under pressure.
Steam leaks from the gasket.
Check if the gasket is damaged.
Run another cycle and check the situation.
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PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION

Check the quantity of material sterilized
and make sure that it does not exceed
Excessive quantity of material inside the the maximum allowed quantity,
sterilization chamber. depending on the type of load.
Technical Characteristics”).
Position the material, and especially
wrapped material, according to the
Material not correctly positioned. instructions.
Excessive humidity on the material (See the Chapter, “Preparing the
and/or instruments at the end of the Material”).
program.
Select the appropriate sterilization
program for the type of material to be
Wrong sterilization program selection treated.
“Programs”).
Drain filter of the sterilization chamber Clean or replace the drain filter
obstructed. (See Appendix “Maintenance”).
Check the quality of the instruments

Quality of the instruments is not with the problem, checking whether the
adequate. material they are made of can tolerate
steam sterilization.
Empty the tank and fill it with high-

quality distilled water.
Quality of the distilled water not
adequate. (See the Water Supply Characteristics
in Appendix “Technical
Characteristics”).
Traces of oxidation or spots on
instruments Carefully clean the material before
Organic or inorganic residues on the subjecting it to the sterilization cycle.
instruments (See the Chapter, “Preparing the
Material”).
Separate instruments made of different
Contact between instruments made of metals.
different metals. (See the Chapter, “Preparing the
Material”).
Clean the device and its parts, as
Lime residue on the wall of the
required.
sterilization chamber and/or accessories.
(See Appendix “Maintenance”).
Check the adequacy of the sterilization

temperature of the selected program in
Blackening of the instruments or relation to the material to be treated.
Wrong sterilization program selection.
damage to the material.
“Programs”).
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APPENDIX – ALARMS
NOTE
IF THE PROBLEM PERSISTS, CONTACT TECHNICAL SERVICE (SEE APPENDIX)
COMMUNICATING THE STERILIZER MODEL AND SERIAL NUMBER.
THIS DATA IS INDICATED ON THE REGISTRATION PLATE ON THE REAR OF
THE DEVICE AND ON THE DECLARATION OF CONFORMITY
INTRODUCTION Every time an anomalous condition occurs during the operation of the sterilizer, an alarm is
generated, identified by a specific code (consisting of a letter followed by a 3-digit number).
Alarm codes are divided into three categories:
• E = ERROR/WARNING
Incorrect handling and/or use or a cause outside the device.
The problem can normally be solved by the user.
Code format: Exxx (xxx = identification number 000 - 999)
• A = ALARM
First level fault
The problem can normally be solved on site by a specialised technician.
Code format: Axxx (xxx = identification number 000 - 999)
• H = HAZARD
Second level fault
The problem can normally be solved by the Technical Service Centre.
Code format: Hxxx (xxx = identification number 000 - 999)
• S = SYSTEM ERROR
Electronic system error (HW-FW).
Code format: Sxxx (xxx = identification number 000 - 999)
NOTE
IN THE CASE OF AN ALARM, PLEASE ONLY REMOVE VOLTAGE FROM
THE DEVICE AFTER EXECUTING A RESET (SEE THE PARAGRAPH,
“RESETTING THE SYSTEM”).
ALARM When the alarm intervenes, the cycle (or normal operation) is interrupted, the relative alarm code
INTERVENTION and message are shown on the display and an acoustic warning is sounded .
Alarm during a cycle The alarm procedure has been devised so that the user cannot confuse an abnormal cycle with a
correctly completed cycle and hence involuntarily use non-sterile material ; it is structured to
guide the user up to sterilizer RESET and subsequent use.
57
FONA Hygenius 17
FONA Hygenius 22
SYSTEM RESET
The system can be reset in two alternative ways depending on the type of alarm that has occurred (see the list of alarm codes
further on in this appendix):
1. Pressing the OK button
2. Following the on-screen instructions and holding down the RESET button for about 3 seconds.
Warning
Error E030
CLOSER TO YOU
Min water level
Pressing the “padlock” button for 3 seconds,

the sterilizer door opens
Warning
Error E030
CLOSER TO YOU Min water level
RESET
Pressing the RESET button for about 3 seconds, you go back to the initial menu.
After the RESET and any technical operation necessary to eliminate the fault, the device will be ready to execute a new program.
WARNING
NEVER TURN OFF THE DEVICE BEFORE HAVING DONE THE RESET.
58
FONA Hygenius 17
FONA Hygenius 22
ALARM CODES
The list of alarm codes and, consequently, the messages displayed on the LCD and relative RESET mode, is as follows:
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE
ERRORS (category E)
E000 Blackout BLACKOUT 2

E001 Excessive mains voltage OVERVOLTAGE 1
E002 Water conductivity threshold 1 exceeded H2O QUALITY INSUFFICIENT 1
E003 Water conductivity threshold 2 exceeded H2O QUALITY INSUFFICIENT 1
E010 Door open DOOR OPEN 1
1
Door lock system activation timeout excee-
E020 DOOR LOCK TIMEOUT (then reattempt or turn
ded (closing)
off)
1
Door lock system activation timeout excee-
E021 DOOR LOCK TIMEOUT (then reattempt or turn
ded (opening)
off)
The water in the feed tank is at minimum
E030
level (MIN)
MIN WATER LEVEL 1
The water in the drain tank is at maximum
E031
level (MAX)
MAX DRAIN LEVEL 1
E040 Tank filling failed (automatic filling) TOP-UP PROBLEM 1
Too frequent tank filling
E041
(automatic filling)
TOP-UP PROBLEM 1
E260 Chamber depressurization too slow PPD SLOW 1
E261 Chamber levelling too slow LEVELLING SLOW 1

Vacuum test failed
E900
(during TEST PHASE)
TEST FAILED 2
Vacuum test failed
E901
(during STANDBY PHASE)
TEST FAILED 2
Vacuum test failed
E902
( vacuum pulse timeout exceeded)
TEST FAILED 2
E999 Manually interrupting the cycle MANUAL INTERRUPTION 2
1 = OK (warning)
2 = OK + door unlocking + RESET
59
FONA Hygenius 17
FONA Hygenius 22
ALARMS (category A)
A022 Door lock microswitch failure (OFF-OFF) DOOR LOCK PROBLEM 1

A032 Problem with the level sensor H2O LEVEL PROBLEM 1
Temperature sensor PT1 failed
A101
(sterilization chamber)
PTx INTERRUPTED 1
A102
(steam generator)
PTx INTERRUPTED 1
A103
(heating element)
PTx INTERRUPTED 1
A105
(conductivity measurement compensation)
PTx INTERRUPTED 1
Temperature sensor PT1 short-circuited
A111
(sterilization chamber)
PTx SHORT-CIRCUITED 1
A112
(steam generator)
A113
(heating element)
A115
A116 ADC error ADC error 1

Reference heating element acquisition chain REFERENCE HEATING ELEMENT
A120
fault FAULT 1
A121
fault FAULT 1
A122
fault FAULT 1
A123
fault FAULT 1
A124
fault FAULT 1
A125
fault FAULT 1
Pre-heating not executed within timeout (ste-
A201
am generator)
GENERATOR WARM-UP PROBLEM 2
Pre-heating not executed within timeout (tube HEATING ELEMENT WARM-UP
A202
bundle heating element) PROBLEM 2
A203 Pre-heating slow (steam generator) GENERATOR WARM-UP SLOW 2

Pre-heating slow (tube bundle heating ele- HEATING ELEMENT WARM-UP
A204
ment) SLOW 2
1 = OK (warning)
60
FONA Hygenius 17
FONA Hygenius 22
ALARMS (category A)
1st vacuum pulse not reached within the ti-
A250
meout
PV1 TIMEOUT 2
1st rise back up to atmospheric pressure not
A251
reached within the timeout
ATM1 TIMEOUT 2
1st pressure pulse not reached within the ti-
A252
meout
PP1 TIMEOUT 2
2nd vacuum pulse not reached within the ti-
A253
meout
PV2 TIMEOUT 2
2nd rise back up to atmospheric pressure not
A254
ATM2 TIMEOUT 2
2nd pressure pulse not reached within the
A255
timeout
PP2 TIMEOUT 2
3rd vacuum pulse not reached within the ti-
A256
meout
PV3 TIMEOUT 2
3rd rise back up to atmospheric pressure not
A257
ATM3 TIMEOUT 2
3rd pressure pulse not reached within the ti-
A258
meout
PPP TIMEOUT 2
Chamber depressurization not completed
A260
within the timeout
PPD TIMEOUT 2
Chamber levelling not completed within the
A261
timeout
LEVELLING TIMEOUT 2
1st drop to atmospheric pressure not comple-
A353
ted within the timeout
DRAIN TIMEOUT 2
2nd drop to atmospheric pressure not comple-
A356
ted within the timeout
DRAIN TIMEOUT 2
1 = OK (warning)
61
FONA Hygenius 17
FONA Hygenius 22
HAZARDS (category H)
H150 The MPX pressure sensor is broken MPX interrupted 3

H160 MPX sensor short-circuited/not connected MPX SHORT-CIRCUITED 3
Pconv/T ratio not balanced (Pconv>T)
H400
( PROCESS phase)
Incorrect P/T ratio 2
T/Pconv ratio not balanced (T>Pconv)
H401
( PROCESS phase)
Incorrect P/T ratio 2
Temperature above the MAXIMUM limit
H402
( PROCESS phase)
T above MAX limit 2
Temperature below the MINIMUM limit
H403
( PROCESS phase)
T below MIN limit 2
Temperature fluctuating over limit
H404
( PROCESS phase)
T FLUCTUATING OVER LIMIT 2
Pressure above MAX limit
H405
( PROCESS phase)
P above MAX limit 2
Pressure below Min limit
H406
( PROCESS phase)
P BELOW MIN LIMIT 2
Retention time incorrect
H410
(PROCESS phase)
TIMER PROBLEM 2
Excessive pressure
H990
(sterilization chamber, MPX)
EXCESSIVE PRESSURE 2
Overheating
H991
(sterilization chamber, PT1)
PT1 OVERHEATING 2
Overheating
H992
(steam generator, PT2)
PT2 OVERHEATING 2
Overheating
H993
(tube bundle heating element, PT3)
PT3 OVERHEATING 2
CODE ALARM DESCRIPTION LCD INDICATION RESET MODE
SYSTEM ERRORS (category S)
S001 Flash memory not accessible FLASH MEMORY NOT ACCESSIBLE 3

S002 Flash memory full FLASH FULL 3
S003 SD memory card not accessible SD CARD NOT ACCESSIBLE 3
S004 SD memory card full SD CARD FULL 3
S005 USB stick not accessible USB STICK NOT ACCESSIBLE 3
S006 USB stick not accessible USB STICK NOT ACCESSIBLE 3
S007 USB stick full USB STICK FULL 3
1 = OK (warning)
62
FONA Hygenius 17
FONA Hygenius 22
ANALYSIS AND RESOLUTION OF PROBLEMS

Based on the type of alarm, below we provide instructions for identifying the possible causes and restoring correct operation:
ERRORS (category E)
CODE POSSIBLE CAUSE SUGGESTED SOLUTION

Wait for the power to be restored and do a RESET following
Sudden power failure (blackout).
the instructions.
The main switch has accidentally been turned off Reconnect the plug and/or turn the device on again and do a
and/or the power plug pulled from the socket. RESET following the instructions.
E 000
Replace with new fuses of the same nominal value. (See sum-
The mains fuses have burned mary table in the Appendix "Technical features"). Turn the
device on again and do a RESET following the instructions.
Do a reset following the instructions. If the problem occurs

E001 Abnormal voltage peak on the mains
again, have the mains electric system checked by a technician.
Do a RESET following the instructions. Empty the feed tank and

refill it with distilled water of adequate quality (<15µs/cm). If an
E002 The feed tank contains water of inadequate quality. automatic filling system is present, empty the external contai-
ner and fill it with water of adequate quality. If a demineralizer
(Pure100/500) is present, replace the filter elements.
Do a RESET following the instructions. IMMEDIATELY empty

the feed tank and refill it with distilled water of adequate quality
(<15µs/cm). If an automatic filling system is present, IMME-
DIATELY empty the external container and fill it with water of
adequate quality. If a demineralizer (Pure100/500) is present,
E003 The feed tank contains water of very poor quality. IMMEDIATELY replace the filter elements.
NOTE: In these conditions, the sterilizer allows starting a MAXI-
MUM OF 5 CONSECUTIVE CYCLES, after which it locks until
the tank is filled with distilled water of adequate quality (<15µs/
cm). This precaution is necessary to prevent possible damage
to the device.
Door open (or not properly closed) at program start Do a RESET following the instructions.
(START). Properly close the doorand restart the program.
E010
Contact Technical Service
Door position microswitch failure.
(see Appendix).
Do a RESET following the instructions.

Door lock mechanism limit microswitch failure.
Try restarting the program a second time.
E020
If the problem persists, contact Technical Service (see the
Door lock system gearmotor failure. Appendix).

Door lock mechanism limit microswitch failure.
E021 Contact Technical Service
(see Appendix).
Door lock system gearmotor failure.

Water level in the feed tank below minimum. Top up with water up to the MAX level (or at least up to over the
E030 MIN level).

MIN water level sensor failure.
(see Appendix).
63
FONA Hygenius 17
FONA Hygenius 22
CODE POSSIBLE CAUSE PROPOSED SOLUTION
Do a RESET following the instructions and empty the tank.

Water level in the drain tank over the MAX level
Completely drain the drain tank.
E031

MAX water level sensor failure.
(see Appendix).

No water in external container (automatic filling) Fill the container with a sufficient amount of water (re-
member to periodically check the level).
E040 Do a Reset following the instructions.

Automatic filling system not properly installed. Check that the filling tube is properly connected.
Remove any obstruction along the tube path.

Automatic filling system failure.
(see Appendix).

Check that the filling tube is properly connected (see the
Automatic filling system not properly installed.
section Installation).
E041 Remove any obstruction along the tube path.
Automatic filling system failure.

Problem in the hydraulic circuit. (see Appendix).
Clean the drain filter (see the Appendix "MAINTENAN-

Drain filter obstructed.
CE").
E260
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).
Clean the drain filter (see the Appendix "MAINTENAN-

Bacteriological filter obstructed.
CE").
E261
Problem in the hydraulic circuit Contact Technical Service (see Appendix).
Do a Reset following the instructions.

Thoroughly clean the gasket with a clean cotton cloth moiste-
Air seepage through the gasket ned with water.
E900 Restart the program.
Problem in the hydraulic circuit.
(see Appendix).

Excessive humidity in the sterilization chamber. Thoroughly dry the inside of the chamber and restart the
program.

E901 Thoroughly clean the gasket with a clean cotton cloth moi-
Air seepage through the gasket
stened with water.
Restart the program.

(see Appendix).
64
FONA Hygenius 17
FONA Hygenius 22

Excessive humidity in the sterilization chamber. Thoroughly dry the inside of the chamber and restart the pro-
gram.
Thoroughly clean the gasket with a clean cotton cloth moiste-
E902 Air seepage through the gasket
ned with water.
Vacuum pump failure.

Manual interruption of the sterilization or test

E 999 Do a RESET following the instructions.
cycle.
ALARMS (category A)
A 022 Door lock mechanism limit microswitch failure.

Water level sensor connector not connected. (see Appendix).
A 032
Water level sensor failure.
A 101 Chamber temperature sensor failure (PT1).
A 102 Steam generator temperature sensor failure (PT2).
A 103 Heating element temperature sensor failure (PT3).

A 105
Incorrect temperature sensor connection (sterilization chamber).

A 111 Contact Technical Service
Temperature sensor short-circuit (sterilization chamber). (see Appendix).
Incorrect temperature sensor connection (steam generator).

A 112
Temperature sensor short-circuit
(steam generator).
Incorrect temperature sensor connection (heating element).

A 113
Temperature sensor short-circuit (heating element).
A115
A116 ADC error
A120 Reference heating element acquisition chain fault

(see Appendix).
65
FONA Hygenius 17
FONA Hygenius 22

Reference heating element acquisition
A123
chain fault
Reference heating element acquisition

A125
chain fault
Steam generator safety thermostat inter-

vened.
A 201
Steam generator or heating element mal-
function.
Heating element safety thermostat inter- Contact Technical Service (see Appendix).
vened.
A 202
Steam generator or heating element mal-
function.
A 203 Steam generator malfunction
A 204 Heating element malfunction

Thoroughly dry the inside of the sterilization chamber and restart the
Water or condensate in the sterilization
cycle.
chamber.
Do not insert material impregnated with water or liquids in general into
the chamber.
Clean the drain filter
Drain filter obstructed.
(see the Appendix "MAINTENANCE").
A 250 Do a RESET following the instructions.

Thoroughly clean the gasket with a clean cotton cloth moistened with
Air seepage through the gasket.
water.
Restart the cycle.

(see Appendix).
Water injection pump malfunction.

A 251 Steam generator safety thermostat inter- (see Appendix).
vened.
Steam generator malfunction
66
FONA Hygenius 17
FONA Hygenius 22

Steam seepage through the gasket. Thoroughly clean the gasket with a clean cotton cloth moistened with water.
Restart the cycle.

Excessive load. Check that the load does not exceed the maximum values permitted.
A 252 (see Summary Table in the Appendix Technical Features).
Steam generator safety thermostat Contact Technical Service (see Appendix).

intervened.
Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE”)
A 353

Thoroughly dry the inside of the sterilization chamber and restart the pro-
Water or condensate in the sterilization
gram.
chamber.
Do not insert material impregnated with water or liquids in general into the
chamber.

A 253
Air seepage through the gasket. Thoroughly clean the gasket with a clean cotton cloth moistened with water.

(see Appendix).

A 254 Steam generator safety thermostat
(see Appendix).
intervened.
67
FONA Hygenius 17
FONA Hygenius 22

Thoroughly clean the gasket with a clean cotton cloth moistened with wa-
Steam seepage through the gasket.
ter.

(see Summary Table in theAppendix Technical Features).
A 255
Steam generator safety thermostat Contact Technical Service

intervened. (see Appendix).
Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 356

Thoroughly dry the inside of the sterilization chamber and restart the pro-
Water or condensate in the steriliza-
gram.
tion chamber.
Do not insert material soaked with water or liquids in general into the
chamber.

A 256
Thoroughly clean the gasket with a clean cotton cloth moistened with wa-
Air seepage through the gasket.
ter.


A 257 Steam generator safety thermostat
(see Appendix).
intervened.

Steam seepage through the gasket. Thoroughly clean the gasket with a clean cotton cloth moistened with water
and restart the program.
A 258 Do a RESET following the instructions.
(see SUMMARY TABLE in the Appendix TECHNICAL FEATURES).
Problem in the hydraulic circuit. Contact Technical Service ( see Appendix).
68
FONA Hygenius 17
FONA Hygenius 22
Steam generator safety thermostat

intervened.
A 258
(see Appendix).
Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 260
Bacteriological filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 261
69
FONA Hygenius 17
FONA Hygenius 22
HAZARDS (category H)
H 150 Pressure sensor (MPX) failure.
Pressure sensor (MPX) not properly

connected to the connector.
H 160
Pressure sensor (MPX) short-circuit.
H 400 Problem in the hydraulic circuit.

H 401 Problem in the hydraulic circuit.
Steam generator malfunction.

H 402

H 403
Problem in the hydraulic circuit. Contact Technical Service
(see Appendix).
H 404

H 405

H 406
H 410 Timer problem

H 990 General operating problem.
70
FONA Hygenius 17
FONA Hygenius 22
SYSTEM ERRORS (category S)
S001 Flash memory not accessible.
S002 Flash Full.
S003 SD Card not accessible

S004 SD Card full (see Appendix).
S005 USB stick not accessible
S006 USB Stick not accessible
S007 USB stick full
71
FONA Hygenius 17
FONA Hygenius 22
APPENDIX – ACCESSORIES
AUTOMATIC FILLING H2O AUXILIARY SOLENOID VALVE
For management of the automatic filling accessories, refer to the previous section WATER FIL-
LING and to the Accessory Manual.
PRINTER
For printer connection, refer to the section "PRINTER".
NOTE
NOT INCLUDED IN THE PACKAGE OF THE MACHINE.
72
FONA Hygenius 17
FONA Hygenius 22
PRINTER Connect the printer to the RS232 serial port located on the rear of the autoclave (see figure).
CONNECTION
Load the desired type of paper and turn on the printer.

Set the type of paper loaded (see the paragraph PRINT MANAGEMENT).
NOTE
REFER TO THE PRINTER MANUAL FOR PRINTER STARTING AND PAPER
LOADING.
73
FONA Hygenius 17
FONA Hygenius 22
APPENDIX – TECHNICAL SUPPORT
FOR ANY REQUEST FOR

TECHNICAL SERVICE FOR THE
PRODUCT,
WHETHER IN OR OUT OF
WARRANTY,
DIRECTLY CONTACT THE
TECHNICAL SUPPORT
DEPARTMENT
OF THE DEALER OR RESELLER

THAT SUPPLIED THE PRODUCT.
We will gladly provide any information you may need on the product as well as give you suggestions and advice on the steam
sterilization procedures.
In this regard, please refer to the following address:
FONA s.r.l.
Via Galileo Galilei 11 - 20090 Assago (MI) Italy
www.fonadental.com
service@fonadental.com
74
We reserve the right to make any alterations which may be required due to clinical improvements
FONA Hygenius 17, FONA Hygenius 22 - Operating Instructions
FONA Dental s.r.o.

Stefanikova 7 SK-811 06
Bratislava, Slovakia
www.fonadental.com

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CLOSER TO YOU

Code Rev. Date Description

CONTENTS OF THE PACKAGE............................................................................................................3

PREPARING THE MATERIAL..............................................................................................................21

STERILIZATION CYCLES ..................................................................................................................24

RUNNING THE CYCLE....................................................................................................................................................... 27

APPENDIX – TECHNICAL CHARACTERISTICS................................................................................40

APPENDIX – GENERAL PROBLEMS.................................................................................................55

APPENDIX – TECHNICAL SUPPORT.................................................................................................74

INTRODUCTION Dear Customer

THE MATERIAL THE STERILIZER IS COMPOSED OF MUST BE DISPOSED

Equipment in accordance with applicable directives.

Consult the user manual.

–– Do not pour water or other liquids on the device;

Dimensions and weight 17 lt 22 lt

In addition to the steriliser, the package contains:

1. No. 5 stainless steel wire instrument tray;

Please refer to the chapter, “Configuration” for more detail.

LCD display and con-

Door closing system

Water drain filter

Distilled water tank drain quick-cou-

Serial cable connection

Power cable connection

Automatic filling electrical connection

Selection of the sterilizer settings (SETUP)

Selection for data management

Sterilization cycle selection

Selection of the test cycles

1. preheating the generator and sterilization chamber;

P res s ure (bar)

SINGLE VACUUM PULSE VACUUM DRYING

Dimensions and weight 17lt 22lt

B. Width (total) 480 mm 480 mm

When installing the sterilizer inside a cabinet, you

Dimensions 17lt 22lt

The following diagram provides an indicative arrangement of the components:

When the sterilizer is turned on, the following page appears:

TO PREVENT BURNS, BE CAREFUL NOT TO TOUCH THE STERILIZA-

Automatic filling Refer to the Appendix "ACCESSORIES".

CUSTOMER SUPPORT (SEE APPENDIX) IS AVAILABLE TO HELP USERS BY

Select the LANGUAGE option and confirm by pressing the OK button.

Date and Time

DATE AND TIME

Date and Time

Act on the + and – buttons to change the value.

Select ON to activate heating in STANDBY or OFF to deactivate it.

Select "Manual filling" and confirm with OK.

TREATING THE An effective cleaning consists of the following:

Notes for rubber and plastic tubing

Notes for packets and packages

Notes for wrapped material

Program selection is fundamental for a successful sterilization process.

To set the parameters, select the following option and confirm.

CLOSER TO YOU 53’ 2.12 Bar

Fractionated vacuum Yes

Fractionated vacuum Yes

CLOSER TO YOU 53’ 2.12 Bar