FONA Hygenius 17 FONA Hygenius 22 Operating instructions

Operating instructions

C L O S E R T O Y O U

English

FONA Hygenius 17FONA Hygenius 22


III

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 CONTENTSINTRODUCTION ....................................................................................................................................1

SYMBOLS USED IN THE MANUAL ...............................................................................................................................1SYMBOLS ON EQUIPMENT ..........................................................................................................................................1

APPLICABLE EUROPEAN DIRECTIVES ............................................................................................................................1INTENDED USE ...................................................................................................................................................................1

IMPORTANT NOTES ......................................................................................................................................................2PURPOSE OF THE MANUAL .............................................................................................................................................2GENERAL WARNINGS ........................................................................................................................................................2

CONTENTS OF THE PACKAGE ...........................................................................................................3DIMENSIONS AND WEIGHT ...............................................................................................................................................3DESCRIPTION OF THE CONTENTS ..................................................................................................................................3HANDLING THE PRODUCT ................................................................................................................................................4

PRODUCT INTRODUCTION .................................................................................................................5INTRODUCTION ..................................................................................................................................................................5GENERAL CHARACTERISTICS ..........................................................................................................................................5FRONT ..................................................................................................................................................................................6REAR ...................................................................................................................................................................................7LCD ICONS ..........................................................................................................................................................................8OPERATING CYCLE EXAMPLE ..........................................................................................................................................9

INSTALLATION ....................................................................................................................................10INTRODUCTION ................................................................................................................................................................10COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATIONS ....................................................................................10GENERAL INSTALLATION PRECAUTIONS ..................................................................................................................... 11ELECTRICAL CONNECTIONS .......................................................................................................................................... 11DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT ....................................................................................12

FIRST START-UP ................................................................................................................................13TURNING ON THE EQUIPMENT .......................................................................................................................................13MAIN MENU ......................................................................................................................................................................14FILLING DISTILLED WATER ............................................................................................................................................15

MANUAL FILLING .........................................................................................................................................................15AUTOMATIC FILLING ...................................................................................................................................................15

CONFIGURATION ...............................................................................................................................16SETTINGS ..........................................................................................................................................................................16

PREPARING THE MATERIAL .............................................................................................................21INTRODUCTION ................................................................................................................................................................21TREATING THE MATERIAL BEFORE STERILIZATION ....................................................................................................21ARRANGING THE ..............................................................................................................................................................22LOAD ..................................................................................................................................................................................22

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

EXTRA DRYING ...................................................................................................................................26


IIII

RUNNING THE CYCLE ......................................................................................................................................................27RESULT OF THE CYCLE ...................................................................................................................................................27DOOR OPENING AT CYCLE END .....................................................................................................................................27MATERIAL STORAGE ........................................................................................................................................................28

TEST PROGRAMS ..............................................................................................................................29INTRODUCTION ................................................................................................................................................................29CYCLE HELIX TEST/B&D ..................................................................................................................................................29CYCLE VACUUM TEST .....................................................................................................................................................31DOOR OPENING ...............................................................................................................................................................33USED WATER DRAIN ........................................................................................................................................................34

DETACHING THE PIPE ................................................................................................................................................34MANUAL INTERRUPTION ................................................................................................................................................35

DATA MANAGEMENT .........................................................................................................................36

APPENDIX – TECHNICAL CHARACTERISTICS ...............................................................................40SUMMARY TABLE..............................................................................................................................................................40SAFETY DEVICES .............................................................................................................................................................41WATER SUPPLY CHARACTERISTICS .............................................................................................................................42

APPENDIX – PROGRAMS ..................................................................................................................43INTRODUCTION ................................................................................................................................................................43PROGRAM SUMMARY TABLE – 17 ..................................................................................................................................44PROGRAM SUMMARY TABLE – 22 ..................................................................................................................................45STERILIZATION PROGRAM DIAGRAM ............................................................................................................................46DIAGRAMS OF THE TEST PROGRAMMES .....................................................................................................................48EXAMPLES OF PRINTED REPORTS ...............................................................................................................................49

APPENDIX – MAINTENANCE .............................................................................................................50INTRODUCTION ................................................................................................................................................................50ORDINARY MAINTENANCE PROGRAM ..........................................................................................................................50

SCHEDULED MAINTENANCE MESSAGES ................................................................................................................50MAINTENANCE DESCRIPTION .......................................................................................................................................52

CLEAN GASKET AND PORTHOLE..............................................................................................................................52CLEAN EXTERNAL SURFACES ..................................................................................................................................52CLEAN STERILIZATION CHAMBER AND ACCESSORIES .......................................................................................52DISINFECT EXTERNAL SURFACES ...........................................................................................................................52BOILER FILTER CLEANING ........................................................................................................................................53REPLACE THE BACTERIOLOGICAL FILTER .............................................................................................................53BOILER GASKET REPLACEMENT..............................................................................................................................53

PERIODIC STERILIZER VALIDATION ...............................................................................................................................54DISPOSAL AT END-OF-LIFE .............................................................................................................................................54

APPENDIX – GENERAL PROBLEMS ................................................................................................55INTRODUCTION ................................................................................................................................................................55ANALYSIS AND RESOLUTION OF PROBLEMS ...............................................................................................................55

APPENDIX – ALARMS ........................................................................................................................57INTRODUCTION ................................................................................................................................................................57ALARM INTERVENTION ....................................................................................................................................................57

ALARM DURING A CYCLE ...........................................................................................................................................57

SYSTEM RESET ..................................................................................................................................58ALARM CODES ..................................................................................................................................................................59ANALYSIS AND RESOLUTION OF PROBLEMS ...............................................................................................................63


IIIIIIIII

APPENDIX – ACCESSORIES .............................................................................................................72PRINTER CONNECTION .............................................................................................................................................73

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


1

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.

NOTEPAY PARTICULAR ATTENTION TO THE PARAGRAPHS MARKED WITH THIS SYMBOL.

WARNINGTHIS SYMBOL INDICATES A POTENTIAL DANGER OF INJURY. FOLLOW THE PROCEDURES DESCRIBED IN THE MANUAL TO AVOID INJURING THE USER AND/OR OTHERS.

DANGERTHIS 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

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.

The FONA Hygenius described in this manual is manufactured in accordance with the highest sa-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: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 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.

WARNINGTHE 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.

APPLICABLE EUROPEAN DIRECTIVES

INTENDED USE

Symbols used in the manual

Symbols on equipment

INTRODUCTION


2

Important notesNOTE

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 MANUAL The purpose of this manual is to provide instructions for:

– 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.

When using this product, always follow the instructions in the manual and never use for anything other than its intended purpose.

WARNINGTHE 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.

WARNINGTHE 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.

DANGERWHENEVER 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.

GENERAL WARNINGS


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3

541 6

B

A

C

3

NOTECHECK THE INTEGRITY OF THE PACKAGE UPON RECEIPT.

Once the package is opened, check that: – the supply matches the specifications of the order

(see the accompanying document); – that there is no obvious product damage;

Dimensions and weight 17 lt 22 ltA. Height 600 mm 600 mm

B. Width 580 mm 580 mm

C. Depth 700 mm 800 mm

Total weight 62 kg 68 kg

NOTEIN 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.

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.

DIMENSIONS AND WEIGHT

DESCRIPTION OF THE CONTENTS

CONTENTS OF THE PACKAGE


4

Where possible, the packaged product must be handled using suitable mechanical means (forklift 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.

WARNINGWE 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.

NOTEKEEP 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.

DANGERBEFORE 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.

HANDLING THE PRODUCT


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PRODUCT INTRODUCTIONINTRODUCTION

GENERAL CHARACTERISTICS

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 the new point of reference with respect to safety, performance, flexibility and ease of use.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.

It is characterized by an advanced fractionated vacuum system for the complete removal of air, 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.

NOTEFOR THE DESCRIPTION OF THE SAFETY DEVICES, REFER TO THE APPEN-DIX TECHNICAL CHARACTERISTICS.


6

FRONT

LCD display and con-trol panel

Sterilization chamber

Door

Door closing system

Bacteriological filter

Water drain filter

On/Off switch

Distilled water tank drain quick-cou-pling (SERVICE only)Used water drain quick connector

Door

Door microswitch

USB port

Door

Door


7

REAR

Heat exchanger

Power cable connection

Mains fuses

Automatic filling electrical connection

Serial cable connection

Connection for automatic distil-led water filling

Connection for Direct water drai-nage



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LCD ICONS

Selection of the sterilizer settings (SETUP)

Selection for data management

Sterilization cycle selection

Selection of the test cycles

NOTEOTHER PARTICULAR SYMBOLS RELATING TO THE VARIOUS CONDITIONS OF USE WILL BE DESCRIBED IN THE RELATIVE PARAGRAPHS.

TIME

SELECTIONICONS

DATE

DOOR OPENINGFORWARD BUTTON

BACKWARD BUTTON

CONFIRMATIONBUTTON


9

The Hygenius series sterilisation programme can be effectively described as a succession of 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.

0.00

1.00

2.00

2.10

Pres s ure (bar)

Time (min)

VACUUM DRYING

PR OC E SS

SINGLE VACUUM PULSE

-0.80

NOTE

PLEASE REFER TO APPENDIX PROGRAMS FOR MORE DETAIL.

OPERATING CYCLE EXAMPLE


A

CB

A

C

B

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The first and fundamental step in achieving good sterilizer operation, long life and complete use 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.

NOTECUSTOMER 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. Width (total) 480 mm 480 mmC. Depth (excluding rear connections) 560 mm 660 mm

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 must provide adequate space all around the device to provide effective ventilation as well as a large enough opening in the back that, in addition to allowing the passage of the power cord will also provide an adequate air flow and the consequent optimum cooling of the heat exchanger.

The compartment where the steriliser will be kept must have the following minimum dimensions:

Dimensions 17lt 22ltA. Height 500 mm 500 mmB. Width 600 mm 600 mmC. Depth 600 mm 700 mm

WARNINGCOMPARTMENT 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.

NOTEIF 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.

INSTALLATIONINTRODUCTION

COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATIONS


11

Obey the following warnings for the correct operation of the device and/or to avoid risky situa-tions:

– 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.

The sterilizer's must be connected to a socket of the electrical system of adequate capacity for 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

WARNINGTHE MANUFACTURER WILL NOT BE LIABLE FOR DAMAGES CAUSED BY INSTALLING THE STERILIZER ON AN INADEQUATE ELECTRICAL SYSTEM AND/OR NOT EQUIPPED WITH A GROUND.

NOTEALWAYS CONNECT THE POWER CORD DIRECTLY TO THE SOCKET. DO NOT USE EXTENSION CORDS, ADAPTERS OR OTHER ACCESSORIES.

GENERAL INSTALLATION PRECAUTIONS

ELECTRICAL CONNECTIONS


12

– Remove the cap holding clip on the rear of the autoclave.

– 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.

NOTEMAKE SURE THE TUBE IS NOT BENT, CRUSHED OR OBSTRUCTED IN ANY WAY.

The following diagram provides an indicative arrangement of the components:

NOTETHE CONNECTION POINT TO THE CENTRAL DRAIN MUST BE LOWER THAN THE STERILIZER'S SUPPORT SURFACE. OTHERWISE, THE TANK MAY NOT EMPTY CORRECTLY.

NOTEFOR 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 TANKINTO THE DRAIN TANK AND FLOWS OUT THE DIRECT DRAIN, THUS PRE-VENTING FLOODING.

DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT

Support plane

To the centralized draining point

Drain siphon

Clamp


Ver. B.21


13

Once the sterilizer has correctly been installed, turn it on with the main switch on the right-hand side of the machine.

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

FIRST START-UP

TURNING ON THE EQUIPMENT


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Once the start procedure has been completed, the main menu shown below appears on the display.

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.

MAIN MENU


15

The distilled water tank must be filled or topped up when using the sterilizer for the first time, and when the water MIN level icon comes on .

Operate as follows (with the machine on) referring to the figure:

1. Remove the rubber cap;

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.

NOTETHE 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.

Refer to the Appendix "ACCESSORIES".

Manual filling

Automatic filling

FILLING DISTILLED WATER


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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.

NOTEUSE 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.

To access the configuration program, select the icon below and press OK.SETTINGS

LANGUAGE

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

Select the desired language by scrolling the list with the arrows (r and s) and confirm by pres-sing the OK button.

OK

Date and Time

LanguageC L O S E R T O Y O U

OK

Inglese

Spagnolo

ItalianoC L O S E R T O Y O U


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DATE AND TIME

Select the DATE AND TIME option and confirm by pressing the OK button.

Select the field to be modified using the arrows and confirm with 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.

OK

hh mm ss11 : 34 : 15

±hh +1

DD MM YYYY 12 / 04 / 2013

OK

hh mm ss11 : 34 : 15

±hh +1

DD MM YYYY 12 / 04 / 2013

OK

Language

Users

Date and TimeC L O S E R T O Y O U




18

STANDBYSelect the STANDBY option and confirm by pressing the OK button.

Select ON to activate heating in STANDBY or OFF to deactivate it.Confirm by pressing OK.

Standby

10’

ON

OK

Standby

10’

ON

OK

Status

Intervall

Status

Intervall

Users

Water filling

StandbyC L O S E R T O Y O U




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WATER FILLING

Select the WATER FILLING option and confirm by pressing the OK button.

Select the desired option based on the accessory actually connected and confirm with OK.

NOTEWHEN 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.

NOTETHIS MENU CAN ALSO BE USED TO TEMPORARILY DEACTIVATE THE AU-TOMATIC FILLING SYSTEM (FILTERS EXHAUSTED, FAULTY, ETC.) AND GO TO MANUAL TANK FILLING.

Select "Manual filling" and confirm with OK.

OK

OK

SV AUX

External pump

Standby

Water filling

Screen

Manual fillingC L O S E R T O Y O U


OK

SV AUX

Manual fillingC L O S E R T O Y O U


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SERVICE

This menu is reserved for Technical Service. It may only be used by an authorised technician.

SCREEN

Select the SCREEN option to adjust the screen brightness and contrast and confirm with OK.

Select the field to be modified using the arrows and confirm with OK.Act on the + and – buttons to change the value. Confirm with OK and continue with modifying the other fields.

OK

Screen

ServiceC L O S E R T O Y O U

OK

OK

5%

100%

OK

5%

100%

Screen

Brightness

Contrast

Screen

Brightness

Contrast

Water filling

Screen

Service





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First of all, it should be recalled that, when handling and managing contaminated material, it is a good idea to take the following precautions:

– Wear rubber gloves of adequate thickness;

– Clean your gloved hands with a germicide detergent;

– 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.).

NOTEIN ADDITION TO CAUSING PROBLEMS DURING STERILIZATION, THE FAI-LURE TO CLEAN AND REMOVE RESIDUE CAN DAMAGE THE INSTRU-MENTS AND/OR THE STERILIZER, ITSELF.

An effective cleaning consists of the following:

1. Rinse the instruments under running water immediately after use;

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.

NOTESOLUTIONS 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.

NOTETO 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).

NOTETHE 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.

WARNINGCONSULT 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.

PREPARING THE MATERIAL

INTRODUCTION

TREATING THE MATERIAL BEFORE STERILIZATION


OK

OK

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.

NOTEDO 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.

Follow the instructions below for the most efficient sterilization process, preserve the material and increase its life time.

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 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.

– Always use the tray support provided.

– To insert and extract trays from the sterilization chamber, always use the extractor provided.

NOTEPLACE 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.

ARRANGING THELOAD


OK

OK

OK

23

Notes for rubber and plastic tubing

– 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.

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.– 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.

WARNINGWHENEVER 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.


24

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 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:

STERILIZATION CYCLES

OK

11/04/13 10:54

OK

134°C Universal B

121°C Universal B




25

USER-DEFINED CYCLE

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

Select the field to be set using the arrows and confirm with OK.Act on the + and – buttons to change the value. Confirm with OK and continue with modifying the other fields.

Press the EXIT button to save all the settings and go back to the previous page.

Press to start the user-defined cycle.

OK

6’

53’

134°C

2.12 Bar

OK

6’4’

134°C

OK

6’4’

134°C

6’

53’

134°C

2.12 Bar

Drying Time Process Time

Temperature

Fractionated vacuum Yes

134°C Prion B

User-defined

Drying Time Process Time

Temperature

Fractionated vacuum Yes

User-defined

User-defined







26

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.

4’

49’

134°C

2.12 Bar

41523

OK

0 min

OK

30 min

4’

49’+30’

134°C

2.12 Bar

Drying Time

134°C Universal B

134°C Universal B

Drying Time






27

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

FIRST VACUUM PHASEFIRST PRESSURE RISE

SECOND VACUUM PHASE5SECOND PRESSURE RISE

THIRD VACUUM PHASETHIRD PRESSURE RISE

STERILIZATION STEAM DISCHARGE

DRYING VENTILATION

CYCLE COMPLETION

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.

To open the sterilizer door, press the button shown in the figure:

RESULT OF THE CYCLE

DOOR OPENING AT CYCLE END

134°C Univ.

4’

134°C

2.12 Bar

39:00

Warming upC L O S E R T O Y O U

134°C Univ.

0’

60°C

1.12 Bar

00:00

Completed


134°C Univ.

0’

60°C

1.12 Bar

00:00

CompletedC L O S E R T O Y O U


28

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.

NOTETHOSE STORAGE PERIODS MIGHT VARY FROM COUNTRY TO COUNTRY, DEPEN-DING ON THE LOCAL LEGAL REQUIREMENTS.

MATERIAL STORAGE


29

To protect the safety of users and patients, a fundamental process like sterilizing medical devices should be periodically checked.

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).

TEST PROGRAMS

INTRODUCTION

CYCLE HELIX TEST/B&D

OK

Vacuum Test

20’ -0.80 Bar

Helix Test/B&D

Helix Test/B&D

11/04/13 10:54

OK





30

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.

NOTETHE 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.

NOTENORMALLY, 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.


31

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.

CYCLE VACUUM TEST

OK

Helix Test/B&D

Vacuum Test

Vacuum Test

20’ -0.80 Bar

23°C

-0.58Vuoto

11:00

Vacuum

11/04/13 10:54

OK






32

The Vacuum Test program is run with the sterilization chamber empty, and only the trays and their supports.

NOTERUN 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.

NOTEIF 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.


11/04/13 10:54

OK


33

To open the autoclave door, hold down the button shown in the figure.

The door opens and stays ajar.

You can now manually open the door.

DOOR OPENING


34

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

USED WATER DRAIN


35

134°C Univ.

4’

134°C

2.12 Bar

39:00

Warming up


MANUAL INTERRUPTION

The cycle can be interrupted manually by the operator at any time by holding down the button shown in the figure for three seconds.

The command generates the error E999 as the cycle could not be completed correctly.

NOTEIF 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".

WARNINGAFTER MANUALLY INTERRUPTING A PROGRAM, DO NOT USE THE LOAD, AS STERILIZATION IS NOT GUARANTEED.

>3 s


36

To access the DATA MANAGEMENT section, select the following icon and press the OK button.DATA MANAGEMENT

pRINT MANAGEMENT

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

Select Print last cycle to choose between printing the Report or the Extended report.

Press ok to select paper type and go back to the previous menu. The cursor is placed on the previously selected paper.

OK

11/04/13 10:54

OK

USB management

Print management



OK

OK

Report

Labels

Print last cycle

Paper settingC L O S E R T O Y O U



37

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).

134°C Univ.

0’

60°C

1.12 Bar

00:00

CompletedC L O S E R T O Y O U

OK

OK

Report

Labels

Print last cycle

Paper settingC L O S E R T O Y O U


At the end of the cycle, press the button indicated to print the report.


38

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.

Once the data has been downloaded, you can remove the USB key.

If the USB key is not present, you are asked to insert it.The sterilization/test cycle files are in PDF format.

NOTEThe USB key must be formatted using the FAT32 file system.

You can select the number of cycles to download to the external memory.

OK

Downl. cycle data

Print management

System informationC L O S E R T O Y O U

OK

Last 50

Insert key

New

Last 10

Download in progress... Download completedRemove key



C L O S E R T O Y O UC L O S E R T O Y O U


39

SYSTEM INFoRMATIoN

Selecting SYSTEM INFORMATION, all the information relating to the sterilizer settings is displa-yed.

OK

Print last cycle

System information

FW version:Serial number:Language:

Autoclave code:



FONA Hygenius 17 FONA Hygenius 22

40

APPENDIX – TECHNICAL CHARACTERISTICS

SUMMARY TABLEDevice Steam SterilizerClassification (according to the Directive 93/42/EEC and subsequent changes)

Hygenius 17 Hygenius 22

Model II b

ManufacturerFONA s.r.l.

Via Galileo Galilei, 1120090 Assago (MI) Italy

Power supply voltage 220 V - 240 V~ 50 Hz220 V - 230 V~ 60 Hz

Mains fuses (6.3 x 32 mm)

F 15A 250V

On-board fuses (5 x 20 mm)

F1: T3.15A 250V (primary transformer) 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 weighted)

< 65 db(A)

Environmental operating conditions

Temperature: +15°C ÷ +35°C Relative humidity: max 80%, non-condensing

Altitude: max 3000 m (a.s.l.)External dimensions (HxWxD) (excluding rear connections)

420 x 480x 560 mm 420 x 480x 660 mm

Net weight:emptyempty with trays and supportiempty, with trays and supports and water at MAX level

about 53 kgabout 54 kg

about 58 kg

about 60 kgabout 62 kg

about 66 kg

Sterilization chamber dimensions (Ø x D)

250 x 350 mm 250 x 450 mm

Sterilization chamber total volume

about 17 l (0.017 m3) about 22 l (0.022 m3)

Sterilization chamber useful volume (with tray supports inserted)

about 10 l (0.010 m3) about 13 l (0.013 m3)

Distilled water tank capacity (supply)

ca. 4,6 l (water at MAX level) ca. 0,8 l (water at MIN level)

Sterilization programs 5 standard programs + 1 user-defined program

Test programs Helix/BD Test Vacuum Test

Preheating time (from cold)

about 10 min

USB connection requires memories formatted with the FAT32 file system

Printer connection RS232 serial (printer cable length max 2.5 m)

Bacteriological filter (PTFE filtering element)

Porosity: 0,2 mm Connection: 1/8” NPT connector


41

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.


42

WATER SUPPLY CHARACTERISTICS

DESCRIPTION WATER SUPPLY VALUES VALUES IN 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 (except iron, cadmium and lead) < 0.1 mg/l < 0.1 mg/l

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

APPEARANCE colorless, transparent, without sediments

colorless, transparent, without sediments

HARDNESS < 0.02 mmol/l < 0.02 mmol/l

NOTEWHEN PURCHASING DISTILLED WATER, ALWAYS CHECK THAT THE QUALITY AND CHARACTERISTICS DECLARED BY THE PRODUCER ARE COMPATIBLE WITH THOSE SHOWN IN THE TABLE.

WARNINGTHE 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.


43

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.

NOTEDEPENDING 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.


44

PROGRAM SUMMARY TABLE – 17

DESCRIPTION CYCLE

NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS

NOTES

Tem

pera

ture

(°

C)

Pres

sure

(b

ar)

Ret

entio

n tim

e

(min

)

Cyc

le ti

me

(EN

130

60

Pre-

vacu

um

(F=f

ract

iona

ted;

S=S

ingl

e)

Stan

dard

dry

ing

(L=l

ong;

C=s

hort

)

Tota

l cyc

le ti

me

(a

vera

ge lo

ad ÷

max

load

)

Aver

age

H2O

con

sum

ptio

n (m

l /cy

cle)

Aver

age

ener

gy c

on-

sum

ptio

n (k

Wh

/cyc

le)

TYPE

MA

X TO

TAL

WEI

GH

T (k

g)

MA

X W

EIG

HT

FO

R T

RAY

(kg)

MA

X W

EIG

HT

FO

R IT

EM (k

g)

134°C UNIVERSAL 134 2.10 4 B F L 37÷40 500 0.8

Unwrapped porous materials 1.00 0.30 0.30

For wrapped materials and instruments (single and double package), it is advisable to use the

3-tray configuration

Porous materials in sin-gle package 0.75 0.25 0.25

Porous materials in double package 0.60 0.20 0.20

Solid and hollow mate-rials in single package 3.00 1.00 0.25

Unwrapped solid and hollow materials 6.00 1.20 0.50

Solid and hollow in-struments A" in double package

1.50 0.50 0.25

134°C PRION 134 2.10 >18 B F L 53÷56 550 0.9




Hollow instruments in single package 3.00 1.00 0.25


Solid and hollow in-struments in double package

1.50 0.50 0.25

121°C UNIVERSAL 121 1.10 20 B F L 52÷55 550 0.8







1.50 0.50 0.25

134°C HOLLOW UNWRAPPED 121 1,10 20 S F C 34÷37 700 0.7

Unwrapped hollow in-struments 7,50 1,50 0.50

Unwrapped solid and hollow materials 7,50 1.20 0.50

S 134°C FLASH 134 2.10 4 S S L 33÷36 300 0.6

Solid and hollow in-struments "B" in single package

3.00 1.00 0.25 It is advisable to use the 3-tray configuration


XXX°C USER (see note)

134 or

121

2.10 or

1.10

>4 or.

>20 n.a. F/S L/C n.a. n.a. n.a.

Unwrapped solid instru-ments (other load types are possible depending on the user settings)

n.a. n.a. n.a.Variable parameters de-pending on the settings

made

HELIX/BD TEST 134 2.10 3.5 - F C 29 - - Test device only (without another load) - - -

VACUUM TEST - -0,80 - - - - 27 - - Empty chamber - - -


45

PROGRAM SUMMARY TABLE – 22

DESCRIPTION CYCLE

NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS

NOTESTe

mpe

ratu

re

(°C

)

Pres

sure

(b

ar)

Ret

entio

n tim

e

(min

)

Cyc

le ti

me

(EN

130

60)

Pre-

vacu

um

(F=f

ract

iona

ted;

S=S

ingl

e)

Stan

dard

dry

ing

(L=l

ong;

C=s

hort

)

Tota

l cyc

le ti

me

(a

vera

ge lo

ad ÷

max

load

)

Aver

age

H2O

con

sum

ptio

n (m

l /cy

cle)

Aver

age

ener

gy c

on-

sum

ptio

n (k

Wh

/cyc

le)

TYPE

MA

X TO

TAL

WEI

GH

T (k

g)

MA

X W

EIG

HT

FO

R T

RAY

(kg)

MA

X W

EIG

HT

FO

R IT

EM (k

g)

134°C UNIVERSAL 134 2.10 4 B F L 40÷43 675 0.8


For wrapped materials and instruments (single and double package), it is advisable to use the

3-tray configuration



Solid and hollow mate-rials in single package 4.00 1.25 0.25


Solid and hollow in-struments A in double package

2.00 0.60 0.25

134°C Prion 134 2.10 >18 B F L 57÷60 700 0.9







2.00 0.60 0.25

121°C UNIVERSAL 121 1.10 20 B F L 55÷58 700 0.8







2.00 0.60 0.25

134°C HOLLOW UN-WRAPPED 121 1.10 20 S F C 34÷37 700 0.7

Unwrapped hollow in-struments 7.50 1.50 0.50


S 134°C FLASH 134 2.10 4 S S L 31÷33 375 0.6

Solid and hollow in-struments "B" in single package

4.00 1.25 0.25It is advisable to use

the 3-tray configurationUnwrapped solid and hollow materials 7.50 1.20 0.50

XXX°C USER (see note)

134 or

121

2.10 or

1.10

>4 or.

>20 n.a. F/S L/C n.a. n.a. n.a.

Unwrapped solid instru-ments (other load types are possible depending on the user settings)

n.a. n.a. n.a.Variable parameters

depending on the set-tings made

HELIX/BD TEST 134 2.10 3.5 - F C 31 - - Test device only (without another load) - - -

VACUUM TEST - -0,80 - - - - 29 - - Empty chamber - - -


46

STERILIZATION PROGRAM DIAGRAM

PROGRAM134°C - UNIVERSAL134°C - 4' 00''

Pressure (bar)

0.00

1.00

2.00

2.10

-0.80

Time (min)

LONG DRYING

PROCESS

PRE-VACUUM

PROGRAM134°C - PRION134°C - 18' 00''

0.00

1.00

1.10

Pressure (bar)

Time (min)

LONG DRYING

PROCESS

FRACTIONATED PRE-VACUUM

PROGRAM121°C - UNIVERSAL121°C - 20'00''

-0.80


47

PROGRAMS 134°C FLASH134°C - 4'00''

Pressure (bar)

0.00

1.00

2.00

2.10

-1.00

Time (min)

LONG DRYING

PROCESS

ONE SHOT PRE-VACUUM

PROGRAMS 134°C FLASH134°C - 4'00''

Pressure (bar)

0.00

1.00

2.00

2.10

-1.00

Time (min)

LONG DRYING

PROCESS

ONE SHOT PRE-VACUUM

S 134°C FLASh 134°C - HOLLOW (UNWRAPP.)


48

DIAGRAMS OF THE TEST PROGRAMMES

PROGRAMBOWIE & DICK TEST 134°C - 3'00''

Pressure (bar)

2.102.00

1.00

- 1.00

Time (min)

SHORT DRYING

PROCESS

FRACTIONATED PRE-VACUUM

0.00

0.00

PROGRAMVACUUM TEST (VT)-0.80 bar

Pressure (bar)

P 0

1.00

0.00 Time (min)

-0.80

t1

P1P2 P3

t2 = t1+300 s

5 minutes 16 minutes

WAITING LEAKAGE

End condition for positive test result

Intermediate condition for the continuation of the test

(P2-P1) < (P0-P1) /10 (P3-P2) < 0.02 bar t3 = t2+600 s

VACUUMPHASE

0.013

10 minutes


49

Program printing (standard)

Model S/N Ver. SW Counter 0007/0015Selection 134 °C SOLIDTemperature 134 °CPressure 2.10 barProcess time 4 minStand-by LOWPre-vacuum SINGLEDrying FAST

CYCLE START 01/02/11 12:14

Time C bar----------------------------------------------------------00:01 CS 079.4 +0.0002:02 1PV 093.7 -0.8005:48 ET 135.6 +2.1506:02 SS 135.9 +2.1707:02 135.6 +2.1408:02 135.5 +2.1409:02 135.4 +2.1410:02 SE 135.5 +2.1510:37 DS 104.1 +0.0011:41 SPD 047.5 -0.9016:08 DE 047.6 -0.8417:12 CE 084.6 -0.04

06:32 MAX 136.009:59 MIN 135.4

Drying PuIses 01CYCLE END 01/02/11 12:36

STERILIZATION: POSITIVE

Model S/N Ver. SW Counter 0007/0015Selection 134 °C UNIVERSALTemperature 134 °CPressure 2.10 barProcess time 4 minStand-by HIGHPre-vacuum FRACTIONATEDDrying STANDARD

CYCLE START 01/02/10 09:52

Time C bar----------------------------------------------------------00:01 CS 075.1 -0.0001:57 1PV 047.S -0.8004:53 1PP 120.5 +1.0007:00 2PV 061.1 -0.8009:15 2PP 120.4 +0.9811:22 3PV 061.1 -0.8015:04 ET 135.5 +2.1515:19 SS 135.9 +2.1716:19 135.4 +2.1417:18 135.5 +2.1518:19 135.4 +2.1419:19 SE 135.5 +2.1519:53 DS 104.4 +0.0020:57 SPD 048.4 -0.9026:55 EPD 094.9 -0.8629:15 DE 112.6 -0.4729:43 CE 115.8 -0.04

16:20 MAX 135.918:11 MIN 135.4

Drying Pulses 05CYCLE END 01/02/11 10:28

STERILIZATION: POSITIVE

Program printing HELIX/BD TEST

Model S/N Ver. SW Counter 0011/0019Selection HELIX TESTTemperature 134 °CPressure 2.10 barProcess time 3.5 minCYCLE START 01/02/11 16:38

Time C bar----------------------------------------------------------00:01 CS 076.4 +0.0002:06 1PV 089.3 -0.8904:35 1PP 120.4 +0.9905:45 2PV 062.5 -0.7807:02 2PP 120.2 +0.9708:15 3PV 061.1 -0.7911:00 .. 135.6 +2.1511:14 .. 136.0 +2.1712:14 135.6 +2.1413:14 135.6 +2.1514:14 135.5 +2.1414:45 .. 135.4 +2.1415:20 .. 111.5 +0.0016:34 … 047.8 -0.8918:21 … 059.5 -0.8619:21 .. 075.4 -0.5020:06 CE 078.7 -0.04

12:33 MAX 136.014:44 MIN 135.4

Drying pulses 01CYCLE END 01/02/11 17:01

HELIX TEST COMPLETE Please attach the indicator hereunder

Program printing VACUUM TEST

Model S/N Ver. SW Counter 0011/0019Selection VACUUM TEST

CYCLE START 01/02/1111:37

Time C bar----------------------------------------------------------00:00 CS 035.0 +0.00

01:39 E1F 037.4 -0.80

6:39 E2F 038.4 -0.79

22:39 E3F 042.0 -0.79

23:54 CE 045.5 -0.01

CYCLE END 01/02/11 12:01

VACUUM TEST: POSITIVE

OPERATOR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

EXAMPLES OF PRINTED REPORTS(WITH OPTIONAL PRINTER)


50

For better quality maintenance, supplement ordinary checks with regular periodic examinations 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.

WARNINGIN THE EVENT OF THE REPLACEMENT OF THE DEVICE’S COMPONENTS OR PARTS, REQUEST AND/OR USE ORIGINAL REPLACEMENT PARTS ONLY.

The table summarizes the maintenance required to keep the sterilizer operating at peak efficiency. In the case of very intense use, we recommend shortening maintenance intervals:

DAILY Clean the gasket on the porthole Clean external surfaces

WEEKLY Clean the sterilization chamber and relative accessories Disinfect external surfaces

MONTHLY

Clean the internal (and external - if installed) distilled water tank Safety valve maintenance Clean (or replace) the drain filter

ANNUALLY Validate sterilizer (see dedicated paragraph)

The steriliser periodically reminds the user about necessary “routine” maintenance operations that must be carried out in order to ensure the proper operation of the device.

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..

INTRODUCTION

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.

ORDINARY MAINTENANCE PROGRAM

Scheduled Maintenance Messages

OK

Message

Replace the bacteriological filterC L O S E R T O Y O U


51

NOTE

The user is given warning messages with the following frequency:

WARNING MESSAGES FREQUENCYBOILER FILTER CLEANING Every 250 cyclesBACTERIOLOGICAL FILTER REPLACEMENT Every 500 cycles

BOILER GASKET REPLACEMENT Every 1.000 cyclesGENERAL 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.

NOTETHE FORMATION OF WHITE SPOTS ON THE BASE OF THE INTERNAL WALLS OF THE STERILIZATION CHAMBER MEANS THAT YOU ARE USING LOW-QUALITY DEMINERALIZED WATER.


52

DANGERBEFORE 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.

Let’s now look at the various operations to be carried out.

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 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 the sterilization chamber, support and trays (and internal surfaces in general) with a 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.

NOTEDO 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).

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).

MAINTENANCE DESCRIPTION

Clean gasket and porthole

Clean external surfaces

Clean sterilization chamber and accessories

Disinfect external surfaces


53

Boiler filter cleaning

Replace the bacteriological filter

Boiler gasket replacement

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.

NOTEPROPERLY FIT THE FILTER IN ITS HOUSING; FITTING IT ONLY PARTIALLY MAY DAMAGE THE COMPONENT.

When filter maintenance is due according to the maintenance schedule or every time you notice 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.

NOTEA SPARE BACTERIOLOGICAL FILTER IS PROVIDED WITH THE STERILIZER. TO ORDER FURTHER FILTERS, REFER TO THE APPENDIX TECHNICAL SERVICE.

It is advisable to have the boiler gasket replaced by an authorised technician, therefore, contact Technical Service (see APPENDIX – TECHNICAL SERVICE).


54

As happens with all equipment, it is possible, and sometimes inevitable, to have a decrease in 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.

In accordance with Directives 2002/95/ EC, 2002/96/ EC and 2003/108/ EC, regarding the 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.

PERIODIC STERILIZER VALIDATION

DISPOSAL AT END-OF-LIFE


55

APPENDIX – GENERAL PROBLEMSINTRODUCTION

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 sterilizer does not power-on.

The power cord is not plugged-in. Plug it in.

There is no voltage at the socket. Check the cause of the lack of voltage at and socket and fix it.

The main switch and/or differential switch are OFF. Turn the switch ON.

The mains fuses are blown.

Replace with good fuses of equal nominal value.

(See the Summary Table in Appendix Technical Characteristics).

After pressing START, the sterilization cycle does not start. The device is preheating.

Wait for the sterilizer to reach the proper operating conditions for starting the program.

NOTE: Under normal conditions, the average preheating time is about 10-15 minutes.

The safety valve has intervened.Locking ring loosened.

Presence of anomalous overpressure in the chamber.

Check that the knurled locking ring is cor-rectly tightened on the upper part of safety valve.

DANGER

LET THE DEVICE COOL, OR WEAR GLOVES TO AVOID BEING BURNED WHEN TOUCHING THE VALVE.

.

There is water on the support surface of the sterilizer.

Automatic water filling system tube (op-tional) not properly connected.

Check the seal of the unions; if necessary, refit paying greater attention.

Check that the tubes are completely fitted on the unions; check that the hose clamps are fitted.

Steam leaks from the gasket.

At the end of the cycle, clean the gasket and porthole of the container under pressure. Check if the gasket is damaged. Run another cycle and check the situation.


56

PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION

Excessive humidity on the material and/or instruments at the end of the program.

Excessive quantity of material inside the sterilization chamber.

Check the quantity of material sterilized and make sure that it does not exceed the maximum allowed quantity, depending on the type of load. (See the Summary Table in Appendix Technical Characteristics”).

Material not correctly positioned.

Position the material, and especially wrapped material, according to the instructions. (See the Chapter, “Preparing the Material”).

Wrong sterilization program selection

Select the appropriate sterilization program for the type of material to be treated. (See the Summary Table in Appendix “Programs”).

Drain filter of the sterilization chamber obstructed.

Clean or replace the drain filter (See Appendix “Maintenance”).

Traces of oxidation or spots on instruments

Quality of the instruments is not adequate.

Check the quality of the instruments with the problem, checking whether the material they are made of can tolerate steam sterilization.

Quality of the distilled water not adequate.

Empty the tank and fill it with high-quality distilled water.

(See the Water Supply Characteristics in Appendix “Technical Characteristics”).

Organic or inorganic residues on the instruments

Carefully clean the material before subjecting it to the sterilization cycle.

(See the Chapter, “Preparing the Material”).

Contact between instruments made of different metals.

Separate instruments made of different metals.

(See the Chapter, “Preparing the Material”).

Lime residue on the wall of the sterilization chamber and/or accessories.

Clean the device and its parts, as required. (See Appendix “Maintenance”).

Blackening of the instruments or damage to the material. Wrong sterilization program selection.

Check the adequacy of the sterilization temperature of the selected program in relation to the material to be treated.

(See the Summary Table in Appendix “Programs”).


57

NOTEIF 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

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/WARNINGIncorrect 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 = ALARMFirst level fault The problem can normally be solved on site by a specialised technician.Code format: Axxx (xxx = identification number 000 - 999)

• H = HAZARDSecond level fault The problem can normally be solved by the Technical Service Centre.Code format: Hxxx (xxx = identification number 000 - 999)

• S = SYSTEM ERRORElectronic system error (HW-FW).Code format: Sxxx (xxx = identification number 000 - 999)

NOTEIN THE CASE OF AN ALARM, PLEASE ONLY REMOVE VOLTAGE FROM THE DEVICE AFTER EXECUTING A RESET (SEE THE PARAGRAPH, “RESETTING THE SYSTEM”).

When the alarm intervenes, the cycle (or normal operation) is interrupted, the relative alarm code and message are shown on the display and an acoustic warning is sounded .

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.

APPENDIX – ALARMS

INTRODUCTION

ALARM INTERVENTION

Alarm during a cycle


58

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.

Pressing the “padlock” button for 3 seconds, the sterilizer door opens

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.

RESET

Min water levelError E030

Warning

Warning

Min water levelError E030



SYSTEM RESET


59

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 1E002 Water conductivity threshold 1 exceeded H2O QUALITY INSUFFICIENT 1

E003 Water conductivity threshold 2 exceeded H2O QUALITY INSUFFICIENT 1E010 Door open DOOR OPEN 1

E020 Door lock system activation timeout excee-ded (closing) DOOR LOCK TIMEOUT

1(then reattempt or turn

off)

E021 Door lock system activation timeout excee-ded (opening) DOOR LOCK TIMEOUT

1(then reattempt or turn

off)

E030 The water in the feed tank is at minimum level (MIN) MIN WATER LEVEL 1

E031 The water in the drain tank is at maximum level (MAX) MAX DRAIN LEVEL 1

E040 Tank filling failed (automatic filling) TOP-UP PROBLEM 1

E041 Too frequent tank filling (automatic filling) TOP-UP PROBLEM 1

E260 Chamber depressurization too slow PPD SLOW 1

E261 Chamber levelling too slow LEVELLING SLOW 1

E900 Vacuum test failed (during TEST PHASE) TEST FAILED 2

E901 Vacuum test failed (during STANDBY PHASE) TEST FAILED 2

E902 Vacuum test failed ( vacuum pulse timeout exceeded) TEST FAILED 2

E999 Manually interrupting the cycle MANUAL INTERRUPTION 2

1 = OK (warning)2 = OK + door unlocking + RESET


60


ALARMS (category A)

A022 Door lock microswitch failure (OFF-OFF) DOOR LOCK PROBLEM 1

A032 Problem with the level sensor H2O LEVEL PROBLEM 1

A101 Temperature sensor PT1 failed (sterilization chamber) PTx INTERRUPTED 1

A102 Temperature sensor PT2 failed (steam generator) PTx INTERRUPTED 1

A103 Temperature sensor PT3 failed (heating element) PTx INTERRUPTED 1

A105 Temperature sensor PT5 failed (conductivity measurement compensation) PTx INTERRUPTED 1

A111 Temperature sensor PT1 short-circuited (sterilization chamber) PTx SHORT-CIRCUITED 1

A112 Temperature sensor PT2 short-circuited (steam generator) PTx SHORT-CIRCUITED 1

A113 Temperature sensor PT3 short-circuited (heating element) PTx SHORT-CIRCUITED 1

A115 Temperature sensor PT5 short-circuited (conductivity measurement compensation) PTx SHORT-CIRCUITED 1

A116 ADC error ADC error 1

A120 Reference heating element acquisition chain fault

REFERENCE HEATING ELEMENT FAULT 1











A201 Pre-heating not executed within timeout (ste-am generator) GENERATOR WARM-UP PROBLEM 2

A202 Pre-heating not executed within timeout (tube bundle heating element)

HEATING ELEMENT WARM-UP PROBLEM 2

A203 Pre-heating slow (steam generator) GENERATOR WARM-UP SLOW 2

A204 Pre-heating slow (tube bundle heating ele-ment)

HEATING ELEMENT WARM-UP SLOW 2



61


ALARMS (category A)

A250 1st vacuum pulse not reached within the ti-meout PV1 TIMEOUT 2

A251 1st rise back up to atmospheric pressure not reached within the timeout ATM1 TIMEOUT 2

A252 1st pressure pulse not reached within the ti-meout PP1 TIMEOUT 2

A253 2nd vacuum pulse not reached within the ti-meout PV2 TIMEOUT 2

A254 2nd rise back up to atmospheric pressure not reached within the timeout ATM2 TIMEOUT 2

A255 2nd pressure pulse not reached within the timeout PP2 TIMEOUT 2

A256 3rd vacuum pulse not reached within the ti-meout PV3 TIMEOUT 2

A257 3rd rise back up to atmospheric pressure not reached within the timeout ATM3 TIMEOUT 2

A258 3rd pressure pulse not reached within the ti-meout PPP TIMEOUT 2

A260 Chamber depressurization not completed within the timeout PPD TIMEOUT 2

A261 Chamber levelling not completed within the timeout LEVELLING TIMEOUT 2

A353 1st drop to atmospheric pressure not comple-ted within the timeout DRAIN TIMEOUT 2

A356 2nd drop to atmospheric pressure not comple-ted within the timeout DRAIN TIMEOUT 2



62


HAZARDS (category H)

H150 The MPX pressure sensor is broken MPX interrupted 3

H160 MPX sensor short-circuited/not connected MPX SHORT-CIRCUITED 3

H400 Pconv/T ratio not balanced (Pconv>T) ( PROCESS phase) Incorrect P/T ratio 2

H401 T/Pconv ratio not balanced (T>Pconv) ( PROCESS phase) Incorrect P/T ratio 2

H402 Temperature above the MAXIMUM limit ( PROCESS phase) T above MAX limit 2

H403 Temperature below the MINIMUM limit ( PROCESS phase) T below MIN limit 2

H404 Temperature fluctuating over limit ( PROCESS phase) T FLUCTUATING OVER LIMIT 2

H405 Pressure above MAX limit ( PROCESS phase) P above MAX limit 2

H406 Pressure below Min limit ( PROCESS phase) P BELOW MIN LIMIT 2

H410 Retention time incorrect (PROCESS phase) TIMER PROBLEM 2

H990 Excessive pressure (sterilization chamber, MPX) EXCESSIVE PRESSURE 2

H991 Overheating (sterilization chamber, PT1) PT1 OVERHEATING 2

H992 Overheating (steam generator, PT2) PT2 OVERHEATING 2

H993 Overheating (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


63

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

E 000

Sudden power failure (blackout). Wait for the power to be restored and do a RESET following the instructions.

The main switch has accidentally been turned off and/or the power plug pulled from the socket.

Reconnect the plug and/or turn the device on again and do a RESET following the instructions.

The mains fuses have burnedReplace with new fuses of the same nominal value. (See sum-mary table in the Appendix "Technical features"). Turn the device on again and do a RESET following the instructions.

E001 Abnormal voltage peak on the mains Do a reset following the instructions. If the problem occurs again, have the mains electric system checked by a technician.

E002 The feed tank contains water of inadequate quality.

Do a RESET following the instructions. Empty the feed tank and refill it with distilled water of adequate quality (<15µs/cm). If an 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.

E003 The feed tank contains water of very poor quality.

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, 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.

E010

Door open (or not properly closed) at program start (START).

Do a RESET following the instructions.Properly close the doorand restart the program.

Door position microswitch failure. Contact Technical Service (see Appendix).

E020Door lock mechanism limit microswitch failure.

Do a RESET following the instructions.Try restarting the program a second time.If the problem persists, contact Technical Service (see the Appendix).Door lock system gearmotor failure.

E021Door lock mechanism limit microswitch failure. Do a RESET following the instructions.

Contact Technical Service (see Appendix).Door lock system gearmotor failure.

E030

Water level in the feed tank below minimum.Do a RESET following the instructions.Top up with water up to the MAX level (or at least up to over the MIN level).

MIN water level sensor failure. Contact Technical Service (see Appendix).


64

CODE POSSIBLE CAUSE PROPOSED SOLUTION

E031Water level in the drain tank over the MAX level

Do a RESET following the instructions and empty the tank.Completely drain the drain tank.

MAX water level sensor failure. Contact Technical Service (see Appendix).

E040

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

Automatic filling system not properly installed.Do a Reset following the instructions. Check that the filling tube is properly connected. Remove any obstruction along the tube path.

Automatic filling system failure. Contact Technical Service (see Appendix).

E041

Automatic filling system not properly installed.

Do a RESET following the instructions.Check that the filling tube is properly connected (see the section Installation).Remove any obstruction along the tube path.

Automatic filling system failure. Contact Technical Service (see Appendix).Problem in the hydraulic circuit.

E260Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENAN-

CE").

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

E261Bacteriological filter obstructed. Clean the drain filter (see the Appendix "MAINTENAN-

CE").

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

E900Air seepage through the gasket

Do a Reset following the instructions. Thoroughly clean the gasket with a clean cotton cloth moiste-ned with water.Restart the program.


E901

Excessive humidity in the sterilization chamber.Do a RESET following the instructions.Thoroughly dry the inside of the chamber and restart the program.

Air seepage through the gasket

Do a RESET following the instructions.Thoroughly clean the gasket with a clean cotton cloth moi-stened with water.Restart the program.



65

ALARMS (category A)

A 022 Door lock mechanism limit microswitch failure.Contact Technical Service (see Appendix).A 032

Water level sensor connector not connected.

Water level sensor failure.

A 101 Chamber temperature sensor failure (PT1).

Contact Technical Service (see Appendix).

A 102 Steam generator temperature sensor failure (PT2).

A 103 Heating element temperature sensor failure (PT3).

A 105 Temperature sensor PT5 failed (conductivity measurement compensation)

A 111Incorrect temperature sensor connection (sterilization chamber).

Temperature sensor short-circuit (sterilization chamber).

A 112Incorrect temperature sensor connection (steam generator).

Temperature sensor short-circuit (steam generator).

A 113Incorrect temperature sensor connection (heating element).

Temperature sensor short-circuit (heating element).

A115 Temperature sensor PT5 short-circuited (conductivity measurement compensation)

A116 ADC error






E902

Excessive humidity in the sterilization chamber.Do a RESET following the instructions.Thoroughly dry the inside of the chamber and restart the pro-gram.

Air seepage through the gasket

Do a RESET following the instructions.Thoroughly clean the gasket with a clean cotton cloth moiste-ned with water.Restart the program.

Vacuum pump failure.Contact Technical Service (see Appendix).Problem in the hydraulic circuit.

E 999 Manual interruption of the sterilization or test cycle. Do a RESET following the instructions.


66





A 201

Steam generator safety thermostat inter-vened.

Steam generator or heating element mal-function.

A 202

Heating element safety thermostat inter-vened.

Steam generator or heating element mal-function.

A 203 Steam generator malfunction

A 204 Heating element malfunction

A 250

Water or condensate in the sterilization chamber.

Do a RESET following the instructions.Thoroughly dry the inside of the sterilization chamber and restart the cycle.Do not insert material impregnated with water or liquids in general into the chamber.

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

Air seepage through the gasket.

Do a RESET following the instructions.Thoroughly clean the gasket with a clean cotton cloth moistened with water.Restart the cycle.

Vacuum pump failure.Contact Technical Service (see Appendix).

Problem in the hydraulic circuit.

A 251

Water injection pump malfunction.



Steam generator safety thermostat inter-vened.

Steam generator malfunction


67


A 252

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

Excessive load.Do a RESET following the instructions.Check that the load does not exceed the maximum values permitted.(see Summary Table in the Appendix Technical Features).


Contact Technical Service (see Appendix).Steam generator safety thermostat intervened.


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


A 253

Water or condensate in the sterilization chamber.

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

Air seepage through the gasket.Do a RESET following the instructions.Thoroughly clean the gasket with a clean cotton cloth moistened with water.Restart the program.

Vacuum pump failure. Contact Technical Service (see Appendix).


A 254




Steam generator safety thermostat intervened.



68


A 255

Steam seepage through the gasket.

Do a RESET following the instructions.Thoroughly clean the gasket with a clean cotton cloth moistened with wa-ter.Restart the program.

Excessive load.Do a RESET following the instructions.Check that the load does not exceed the maximum values permitted. (see Summary Table in theAppendix Technical Features).





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


A 256

Water or condensate in the steriliza-tion chamber.

Do a RESET following the instructions.Thoroughly dry the inside of the sterilization chamber and restart the pro-gram.Do not insert material soaked with water or liquids in general into the chamber.

Air seepage through the gasket.

Do a RESET following the instructions.Thoroughly clean the gasket with a clean cotton cloth moistened with wa-ter.Restart the program.

Vacuum pump failure.Contact Technical Service (see Appendix).Problem in the hydraulic circuit.

A 257






A 258

Steam seepage through the gasket.Do a RESET following the instructions.Thoroughly clean the gasket with a clean cotton cloth moistened with water and restart the program.

Excessive load.Do a RESET following the instructions.Check that the load does not exceed the maximum values permitted.(see SUMMARY TABLE in the Appendix TECHNICAL FEATURES).

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


69


A 258

Steam generator safety thermostat intervened. Contact Technical Service

(see Appendix).Steam generator malfunction

A 260Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").


A 261Bacteriological filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").



70


H 150 Pressure sensor (MPX) failure.


H 160

Pressure sensor (MPX) not properly connected to the connector.

Pressure sensor (MPX) short-circuit.

H 400 Problem in the hydraulic circuit.

H 401 Problem in the hydraulic circuit.

H 402Steam generator malfunction.


H 403Steam generator malfunction.


H 404Problem in the hydraulic circuit.

Steam generator malfunction.

H 405



H 406



H 410 Timer problem

H 990 General operating problem.




HAZARDS (category H)


71


S001 Flash memory not accessible.


S002 Flash Full.

S003 SD Card not accessible

S004 SD Card full

S005 USB stick not accessible

S006 USB Stick not accessible

S007 USB stick full

SYSTEM ERRORS (category S)


72

APPENDIX – ACCESSORIES

AUTOMATIC FILLING

PRINTER

For management of the automatic filling accessories, refer to the previous section WATER FIL-LING and to the Accessory Manual.

For printer connection, refer to the section "PRINTER".

H2O AUXILIARY SOLENOID VALVE

NOTENOT INCLUDED IN THE PACKAGE OF THE MACHINE.


73

PRINTER CONNECTION

Connect the printer to the RS232 serial port located on the rear of the autoclave (see figure).

Load the desired type of paper and turn on the printer.Set the type of paper loaded (see the paragraph PRINT MANAGEMENT).

NOTEREFER TO THE PRINTER MANUAL FOR PRINTER STARTING AND PAPER LOADING.


74

APPENDIX – TECHNICAL SUPPORT

FOR ANY REQUEST FORTECHNICAL 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

[email protected]

We reserve the right to make any alterations which may be required due to clinical improvements

FONA Hygenius 17, FONA Hygenius 22

FONA Dental s.r.o. Stefanikova 7 SK-811 06 Bratislava, Slovakia

www.fonadental.com

- Operating Instructions

Documents

FONA Hygenius 17 FONA Hygenius 22 Operating instructions