Operating instructions

classicFamily of Steam sterilizers B28 series - B CLASSIC models:

B Classic-28

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

97050949 0 03-2017 First issue

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 .............................................................................................................29InTRoduCTIon ................................................................................................................................................................29TReaTInG The maTeRIal beFoRe STeRIlIzaTIon ....................................................................................................29aRRanGInG The ..............................................................................................................................................................30load ..................................................................................................................................................................................30

STERILIZATION CYCLES .................................................................................................................32

EXTRA DRYING ...................................................................................................................................34

IIII

PROGRAMMED STARTING ................................................................................................................35RunnInG The CyCle ......................................................................................................................................................36ReSulT oF The CyCle ...................................................................................................................................................36dooR openInG aT CyCle end .....................................................................................................................................36maTeRIal SToRaGe ........................................................................................................................................................37

TEST PROGRAMS ..............................................................................................................................38InTRoduCTIon ................................................................................................................................................................38CyCle helIx TeST/b&d (only FoR b VeRSIonS) .....................................................................................................38CyCle VaCuum TeST .....................................................................................................................................................40VaCuum TeST + helIx TeST/b&d CyCle (only FoR b VeRSIonS) ........................................................................41h2o TeST (only FoR b VeRSIonS) ..............................................................................................................................41dooR openInG ...............................................................................................................................................................42uSed WaTeR dRaIn ........................................................................................................................................................43

deTaChInG The pIpe ................................................................................................................................................43manual InTeRRupTIon ................................................................................................................................................44

DATA MANAGEMENT .........................................................................................................................45

APPENDIX – TECHNICAL CHARACTERISTICS ...............................................................................49SummaRy Table..............................................................................................................................................................49SaFeTy deVICeS .............................................................................................................................................................50WaTeR Supply ChaRaCTeRISTICS .............................................................................................................................51

APPENDIX – PROGRAMS ..................................................................................................................52InTRoduCTIon ................................................................................................................................................................52

pRoGRam SummaRy Table b ClaSSIC-28 120 V~ 60 hz ......................................................................................................................................................................60STeRIlIzaTIon pRoGRam dIaGRam ............................................................................................................................61dIaGRamS oF The TeST pRoGRammeS .....................................................................................................................63exampleS oF pRInTed RepoRTS ...............................................................................................................................64

APPENDIX – MAINTENANCE .............................................................................................................65InTRoduCTIon ................................................................................................................................................................65oRdInaRy maInTenanCe pRoGRam ..........................................................................................................................65

SCheduled maInTenanCe meSSaGeS ................................................................................................................65maInTenanCe deSCRIpTIon .......................................................................................................................................67

IIIIIIIII

Clean GaSkeT and poRThole..............................................................................................................................67Clean exTeRnal SuRFaCeS ..................................................................................................................................67Clean STeRIlIzaTIon ChambeR and aCCeSSoRIeS .......................................................................................67dISInFeCT exTeRnal SuRFaCeS ...........................................................................................................................67boIleR FIlTeR CleanInG ........................................................................................................................................68dooR loCk lubRICaTIon ........................................................................................................................................68duST FIlTeR CleanInG (only FoR b VeRSIonS) ...............................................................................................69ReplaCe The baCTeRIoloGICal FIlTeR .............................................................................................................69WaTeR Tank CleanInG ............................................................................................................................................69boIleR GaSkeT ReplaCemenT..............................................................................................................................69

peRIodIC STeRIlIzeR ValIdaTIon ...............................................................................................................................70dISpoSal aT end-oF-lIFe .............................................................................................................................................70

APPENDIX – GENERAL PROBLEMS ................................................................................................71InTRoduCTIon ................................................................................................................................................................71analySIS and ReSoluTIon oF pRoblemS ...............................................................................................................71

APPENDIX – ALARMS ........................................................................................................................73InTRoduCTIon ................................................................................................................................................................73alaRm InTeRVenTIon ....................................................................................................................................................73

alaRm duRInG a CyCle ...........................................................................................................................................73

SYSTEM RESET ..................................................................................................................................74alaRm CodeS ..................................................................................................................................................................75analySIS and ReSoluTIon oF pRoblemS ...............................................................................................................79

APPENDIX – ADMIN USER PIN RESET ............................................................................................88

APPENDIX – ACCESSORIES .............................................................................................................89pRInTeR ConneCTIon .............................................................................................................................................90

APPENDIX – TECHNICAL SUPPORT ................................................................................................91

1

INTRODUCTION 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 SpeCIal aTTenTIon To paRaGRaphS IndICaTed by The poInTInG FInGeR.

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.

potenzial hazard due to high temperature.

equipment in accordance with applicable directives.

Symbol for disposal in accordante with directive 2012/19/UE.

Consult the user manual.

The product described in this manual is manufactured in accordance with the highest safety 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.

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.

WARNING

The STeRIlIzeR IS noT a mobIle oR poRTable deVICe.

APPLICABLE EUROPEAN DIRECTIVES

Symbols used in the manual

Symbols on equipment

INDICATION FOR USE

The Family of steam Sterilizers B 28 series are table top steam sterilizers to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process. The Family of Steam Sterilizers B 28 series is validated for sterilization of fabric packs/textiles for sterilization programs C1 and C2.The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2.The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the "PROGRAM SUMMARY TABLE").The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

2011/65/EU (Rohs II) on the restriction of the use of certain hazardous substances inelectrical and electronic equipment.

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

2

3

5

6

894

1

7

10

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 weighta. height 600 mm

b. Width 600 mm

C. depth 700 mm

Total weight 65 kg

NOTEIn The CaSe oF a WRonG pRoduCT, mISSInG paRTS oR any Type oF damaGe, ImmedIaTely pRoVIde a deTaIled deSCRIpTIon To The Re-SelleR and The TRanSpoRTeR ThaT made The delIVeRy.

In addition to the steriliser, the package contains:

1. No. 6 stainless steel wire instrument tray;2. Stainless steel wire tray support;3. operating documentation (with Cd-Rom);4. lubricant for door lock mechanism;5. Tray extractor;6. Extra bacteriological filter;7. Rubber hose with quick-coupling for manual water drainage;8. 1/8” swivel angular connector;9. 5mm socket wrench for manual door unlocking;10. plastic tube for direct water drainage with fastening clamp;11. Rear spacers.

Where possible, the packaged product must be handled using suitable mechanical means (forklift truck, transpallet, etc.) and following the instructions shown on the package.

DIMENSIONS AND WEIGHT

DESCRIPTION OF THE CONTENTS

B

A

C

CONTENTS OF THE PACKAGE

4

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 and possibly handled with a lift truck or similar.

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

CONDITIONS FOR STORAGE AND TRANSPORT

TEMPERATURE: between +5° C and +70° C

HUMIDITY: between 20% and 80%

PRESSURE: between 50 and 110 kPa

5

PRODUCT INTRODUCTIONINTRODUCTION

GENERAL CHARACTERISTICS

The Classic series sterilisers are the new products offered by MOCOM in the field of small 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, small size and pleasant appearance, it is the ideal partner for all professional who demand the maximum sterilization safety.

a Classic 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 the fast, effective sterilization of the various types of loads (instruments 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.

like in the best tradition, also the new range of autoclaves Classic have the most complete, sophisticated and advanced safety systems available today, giving the user a guarantee 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

used water drain quick connector

door

distilled water top-up quick-cou-pling (only FoR b VeRSIonS)

Dust filter (only FoR b VeRSIonS)

distilled water tank drain quick-coupling Quick connector Service only (laser marked label)

7

REAR

Heat exchanger

power cable connection

mains fuses

Automatic filling electrical connection (only FoR b VeRSIonS)

Serial cable connection

data label

Rear spacer fastening slots

Connection for automatic distilled water filling (only for PURE 100/500 and the automatic filling accessory kit) (water inlet connector) (ONLY FOR B VERSIONS)

Connection for direct water (water drain connector)

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OK

8

LCD ICONS

Selection of the sterilizer settings (SeTup)

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Selection for data management

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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.

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TIme

SeleCTIonIConS

daTe

dooR openInG

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InCReaSebuTTon

deCReaSebuTTon

ConFIRmaTIonbuTTon

9

The Classic series sterilisation programme can be effectively described as a succession of pha-ses, 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 CyCLEExAMPLE

A

B

A

C

B

10

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 damage, not to mention malfunctions and damage to the machine. So, please follow the instructions in this chapter scrupulously.

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

a. height (total) 500 mm

b. Width (total) 480 mmC. Depth (excluding rear connections) 600 mm

Total weight 60 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 pro-vide 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 ade-quate 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:

Dimensionsa. height 500 mm with FRonT FIllInG kIT

670 mm with FIllInG FRom The Top (door)b. Width 600 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.

INSTALLATION

INTRODUCTION

COMPARTMENTDIMENSIONS 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 (provided).

– Fit the union and then refit the clip.

– Fasten the clip provided 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, puRe 100, puRe 500, eV7) The dIReCT dRaIn muST alWayS be ConneCTed.ThIS aCTS aS an oVeRFloW, and, IF FoR Some ReaSon, The FIllInG SySTem doeS noT STop, The WaTeR SeepS FRom The Feed Tank InTo The dRaIn Tank and FloWS ouT The dIReCT dRaIn, ThuS pRe-VenTInG FloodInG.

DIRECT CONNECTION TO A CENTRALIzED DRAINING POINT

Support plane

To the centralized draining point

drain siphon

Clamp

13

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

FIRST START-UP

TURNING ON THE EqUIPMENT

WARNING

DO NOT TURN ON THE STERILIZER, IF USB KEY IS INSERTED.

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

14

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OK

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 first time the sterilizer is used, and later when the MIN water level indicator comes on, you will have to fill, or top-off, the internal distilled water tank.

open the loading door.

Pour in water taking care not to exceed the maximum level (MAX) indicated inside the tank. Close the door.

be carefulnot to spill any water on the machine, and if so, immediately dry it off.

WARNINGThe Tank muST be FIlled beFoRe The CyCle STaRTS oR aFTeR ITS CompleTIon.do noT open The Tank dooRS duRInG CyCle exeCuTIon In oRdeR To pReVenT WaTeR leakS.

Refer to the Appendix "ACCESSORIES".

Manual filling

Automatic filling

FILLING DISTILLEDWATER

BEEP

16

CONFIGURATION The CLASSIC 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.

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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

Users

Date and Time

OK

English

Spanish

Italian

Language

WARNINGTHE CUSTOM PROGRAM HAS NOT BEEN VALIDATED. PLEASE REFER TO THE “PROGRAM SUMMARY TABLE” AND ITS GENERAL NOTES FOR THE LIST OF AVAILABLE PROGRAMS, THEIR SCREENS AND THE CHARACTERISTICS OF STERILIZABLE MATERIALS (IN RELATION TO THE PROGRAMS).

WARNINGTHE FAST, INTELLIGENT AND EXTRA DRYING OPTIONS HAVE NOT BEEN VALIDATED. PLEASE REFER TO THE “PROGRAM SUMMARY TABLE” AND ITS GENERAL NOTES (SEE APPENDIX – PROGRAMS) FOR A DESCRIPTION OF THE DRYING OPTIONS AND THE MAXIMUM STERILIZABLE MASS ALLOWED IN EACH STERILIZATION PROGRAM.

17

DATE AND TIME

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

OK

Language

Users

Date and Time

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

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.

18

USERS

Access the menu by selecting the USERS option and confirm with OK. Fill in the fields entering the user name and PIN.

enter the pIn of the system administrator (admin), selecting a 4-digit numerical code.

after entering the pIn, you access the menu reserved for the administrator.To create a new user, select the uSeR lIST option from the list of options

and then "Create new user"

OK

Date and Time

Users

PIN

Admin

1---OK

OK

User 1

Create new user

OK

PIN change

User list

PIN request

19

Use the + and – buttons to enter the identification “short name” of the new user, entering one letter at a time and confirming with OK until complete.

When the PIN is requested, the first field is activated. Enter the value using the + and - buttons (numbers from 0 to 9). Pressing OK you go to the next value until the last one that confirms the PIN

OK

New user

OK

PIN

Vero

VE--

New user

----OK

7---

OK

Create new user

Vero

*Admin

OK

PIN

7145

Vero

20

Select the user from the list if already existent.once accessed, non admIn users can see only a summary of their data or change their pIns (see PIN entry – requested in sequence is: current PIN, new PIN, confirmation of new PIN).

uSeR daTa

admIn users, on the other hand, have the following rights: pIn change: they can change its pInuser listpIn requestuser deletion

OK

PIN change

User creation date: 15/04/2013

Vero

Cycles launched/completed: 102/101

User data

OK

PIN change

User list

OK

PIN request

Delete user

21

pIn ChanGe by admInISTRaToR.

Select the option shown below and confirm with the OK button.

OK

PIN change

User list

New PIN

User 1

----

Current PIN

User 1

----OK

OK

enter the current pIn.

enter the new pIn.

NOTEIF The admIn uSeR enTeRS The pIn InCoRReCTly ThRee TImeS, The nexT TIme The pIn IS RequeSTed, The SpeCIFIC unloCkInG Code needS To be enTeRed (See appendIx – ReSeT admIn uSeR pIn) aT The end oF ThIS manual.

SubSequenT aCCeSS To The uSeR menu WIll be lIke aT FIRST poWeR on.

22

uSeR lIST.Select the option shown below and confirm with the OK button.

OK

PIN change

User list

PIN request

OK

*Admin

User 3

User 2

User creation date: 15/04/2013

User 2

Cycles launched/completed: 102/101

OK

User list

PIN request

Delete users

OK

Cycle start

Cycle End

X

OK

Cycle start

Cycle End

X

Select the desired user. pressing ok you access the page with the data relating to the user selected.

you can activate only one of the two options or both.activating "Cycle Start", the system will ask you to enter the pIn at the start of the sterilization cycle. activating "Cycle end", the system will ask you to enter the pIn at the end of the cycle before unlocking the door.

pIn RequeST.Select the option shown below and confirm with the OK button.

23

If the request for the pIn at cycle start is set, when pressing the STaRT button, you are asked to select the user and the relative pIn.

OKUser 3

User 2

PIN

User 1

---- OK

User 1

134°C Univ.

4’

134°C

2.12 BarWarming up

39:00

134°C Universal B

4’

49’

134°C

2.12 Bar

Once the PIN has been confirmed, the cycle automatically starts.

24

If the request for the pIn at cycle end is set, pressing the door unlocking button, the summary page of the parameters relating to the sterilization cycle will be shown.

OK

User 3

User 2

PIN

User 1

----OK

User 1

134°C Univ. 4’

max 134,7°Cmin 134,3°C

max 2.12 Barmin 2,01 Bar

OK

134°C Univ.

0’

60°C

1.12 BarCompleted

00:00

Once the PIN has been confirmed, the autoclave door opens and you can take out the load.

Pressing OK, the user confirms the positive outcome of the cycle and authorises taking delivery of the sterilized mate-rial.

25

OK

PIN request

Delete users

OK

User 3

User 2

User 2

Do you confirm deletion ?

OK

The admIn user can delete one or more users.Select the option in the list and press ok to access the user list. Select the user you want to delete and press OK to confirm or to exit the page.Confirm deletion by pressing OK.

deleTe uSeRS.

26

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.

OK

Standby

10’

ON

OK

Standby

Status

Interval 10’

ON

OK

Users

Water filling

Standby

Status

Interval

27

OK

Pure 100

External pump

Pure 500

OK

Standby

Water filling

Screen

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.

NOTEONLY FOR B VERSIONSWhen 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.

OK

External pump

Manual filling

Select "Manual filling" and confirm with OK.

28

OK

Screen

Service

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

Brightness

Contrast 5%

100%

OK

Screen

Brightness

Contrast 5%

100%

OK

Water filling

Screen

Service

29

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 solutioncarefully 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 completelyeliminated; 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 handles (turbines, contra-angles, etc.), supplement the above with treatment in suitable dedi-cated devices that provide effective internal cleaning (occasionally including lubrication).

NOTEThe end oF The STeRIlIzaTIon pRoGRam, RemembeR To lubRICaTe The InTeRnal handle meChanISmS uSInG The SpeCIal STeRIle oIl. by TakInG TheSe pReCauTIonS, The InSTRumenTS uSeFul lIFe 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. SCRupulouSly FolloW The meThodS oF uSInG deTeRGenTS oR dI-SInFeCTanTS and The uSaGe InSTRuCTIonS oF The auTomaTIC de-VICeS FoR WaShInG and/oR lubRICaTInG Them.

PREPARING THE MATERIAL

INTRODUCTION

TREATING THE MATERIAL BEFORE STERILIzATION

OK

OK

30

on the other, 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 useful life.

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).

– 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

31

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 samewrapping, 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.

32

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:

11/04/13 10:54

OK

OK

134°C Universal B

134°C Hollow S

121°C Universal B

OK

134°C Solid S

STERILIZATION CYCLES

User-defined

33

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 Drying Time Process Time

Temperature

Fractionated vacuum Yes

6’4’

134°C

OK

SI

4’

134°C

OK

User-defined

OK Drying Time Process Time

Temperature

Fractionated vacuum Yes

6’4’

134°C

User-defined

6’

53’

134°C

2.12 Bar

User-defined

6’

53’

134°C

2.12 Bar

134°C Solid S

34

EXTRA DRYING

OK

Drying Time

30 min

134°C Universal B

4’

49’

134°C

2.12 Bar

134°C Universal B

01:30

4’

49’+30’

134°C

2.12 Bar

OK

Drying Time

0 min

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.

35

Select the SCheduled STaRT option by tapping the button indicated.act on the + and – buttons to set the time and confirm.After confirmation, the time set is shown on the display. To activate delayed starting, press the ok button.

PROGRAMMED STARTING

OK

Delay Start

00:0016/04/13 - 12:58

OK

Delay Start

15:3016/04/13 - 14:28

134°C Universal B

15:30

4’

49’+30’

134°C

2.12 Bar

134°C Universal B

4’

49’

134°C

2.12 Bar

36

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 phaSeSeCond 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:

134°C Univ.

4’

134°C

2.12 BarWarming up

39:00

134°C Univ.

0’

60°C

1.12 BarCompleted

00:00

OK

Stampa etichette

N°etich.

Scadenza (gg) 10

20

NO

134°C Univ.

4’

134°C

2.12 BarWarming up

39:00

134°C Univ.

0’

60°C

1.12 BarCompleted

00:00

OK

Stampa etichette

N°etich.

Scadenza (gg) 10

20

NO

RESULT OF THE CyCLE

DOOR OPENING AT CyCLE END

134°C Univ.

0’

60°C

1.12 BarCompleted

00:00

37

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 anyrate, separate the sterile material from the area where contaminated material is kept waitingto be sterilized;

3. Touch the material and/or instruments as little as possible, taking extreme care not to cut ordamage 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 beclosed 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 duringsterilization. Do not wrap the instruments after sterilization since, in addition to being uselessand 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 printedreport or an adhesive label);

4. First use the material that has been stored the longest (FIFo, "First In First out"). This resultsin material that is homogeneously stored, avoiding storing for too long, with the consequentrisks.

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 MATERIALRELATIvE To ThE MAxIMUM ALLowED SToRAGE TIME.

MATERIAL STORAGE

38

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

In this regard, the Classic series offer the possibility of easily and automatically executing two distinct test cycles:

• Helix/B&D Test (ONLY FOR B VERSIONS).• Vacuum Test

a program that executes the two tests combined is also available Vacuum + B/D (ONLY FOR B VERSIONS).

There is also a further test to check the water quality: H2O TEST (ONLY FOR B VERSIONS).

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).

To select the Helix/B&D Test cycle, select Helix Test/B&D using the arrows and confirm with OK.

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OK

OK

Vacuum Test

Vacuum + B/D

Helix Test/B&D

Helix Test/ B&D

00:00

49’ 2.12 Bar

TEST PROGRAMS

INTRODUCTION

CyCLE HELIx TEST/B&D (ONLy FOR B VERSIONS)

39

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.

40

The Vacuum Test cycle allows testing perfect seal of the sterilizer hydraulic system.Measuring the variation of the degree of vacuum in a defined time-frame and comparing it with pre-established limit values, you can determine how good the seal of the sterilization chamber, tubes and the various interception devices is.

To select the Vacuum Test cycle, select Vacuum Test using the arrows and confirm with OK.

11/04/13 10:54

OK

Vacuum Test

00:00

15’

Vacuum Test

0’

40°C

-0.78 barVacuum

08:00

OK

Vacuum Test

Helix Test/B&D

-0.80 bar

CyCLE VACUUM TEST

41

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.

Selecting this option, you can run a VaCuum TeST cycle and a helIx TeST/b&d CyCle In SequenCe.

To this end, place the test device on the central tray without inserting other material.Close the door and start the cycle.The program will execute the two cycles in succession.Check the results as described in the previous paragraphs.

NOTEThe pReSenCe oF The helIx TeST deVICe doeS noT alTeR exeCu-TIon and The ReSulT oF The VaCuum TeST CyCle.

Selecting this option, you can test the water quality .

VACUUM TEST + HELIx TEST/B&D CyCLE (ONLy FOR B VERSIONS)

OK

Helix Test/B&D

H2O Test

Vacuum + B/D

H2O TEST (ONLy FOR B VERSIONS)

H2O Test

15 µSExcellent Normal Substandard

OK

Vacuum + B/D

H2O Test

NOTEThe WaTeR ConduCTIVITy IS auTomaTICally meaSuRed aT eaCh STeRIlIzaTIon oR TeST CyCle STaRT.

42

11/04/13 10:54

OK

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

43

To activate the automatic tank filling option, refer to the section “Configuration”.

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 endof 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

WARNING

do noT open The Tank dooRS duRInG CyCle exeCuTIon In oRdeR To pReVenT hoT WaTeR leakS oR SpuRTS.

44

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.

134°C Univ.

4’

134°C

2.12 BarWarming up

39:00

>3 s

45

To access the daTa manaGemenT section, select the following icon and press the ok button.DATA MANAGEMENT

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OK

OK

Gestione stampe

Informazioni di sistema

Gestione USB

pRINT MANAGEMENT

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

OK

Report

Labels

OK

Print last cycle

Paper setting

OK

USB management

Print management

Selecting papeR SeTTInG, you can select which paper to use: roll of label paper (ONLY FOR B VERSIONS) or roll of continuous paper.

46

OK

Print labels

No. of labels

Expiry (days) 10

20

Print labels

No. of labels

Expiry (days) 10

20

OK

Print labels

No. of labels

Expiry (days) 10

20

Select the field to be set using the arrows (number of labels to be printed at the end of the cycle and material expiry) 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.If the printer is connected to the autoclave with the RepoRT option set, the sterilizer will automa-tically print the summary report at the end of the cycle.

Selecting the pRInT laST CyCleoption 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).

OK

Paper setting

Print technical report

Print last cycle

134°C Univ.

0’

60°C

1.12 BarCompleted

00:00

at the end of the cycle, when tapping the button indicated, the following page is displayed only if the printer is connected to the sterilizer and set for label printing (settable from print manage-ment).If not, the sterilizer automatically prints the report.

47

USb MANAGEMENT

before carrying out the following operations, insert the uSb key.

Selecting uSb manaGemenT, you can choose whether to download the data or the technical report.

once the data has been downloaded, you can remove the uSb key.

WARNING

DO NOT TURN ON THE STERILIZER, IF USB KEY IS INSERTED.

Insert key

Download in progress...

Download completedRemove key

OK

New

All

Last 10

OK

Print management

System information

USB management

OK

Download technical report

Downl. cycle data

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.

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.

Insert key

Download in progress...

Download completedRemove key

OK

New

All

Last 10

OK

Print management

System information

USB management

OK

Download technical report

Downl. cycle data

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

Insert key

Download in progress...

Download completedRemove key

OK

New

All

Last 10

OK

Print management

System information

USB management

OK

Download technical report

Downl. cycle data

Insert key

Download in progress...

Download completedRemove key

OK

New

All

Last 10

OK

Print management

System information

USB management

OK

Download technical report

Downl. cycle data

Insert key

Download in progress...

Download completedRemove key

OK

New

All

Last 10

OK

Print management

System information

USB management

OK

Download technical report

Downl. cycle data

Insert key

Download in progress...

Download completedRemove key

OK

New

All

Last 10

OK

Print management

System information

USB management

OK

Download technical report

Downl. cycle data

48

SYSTEM INFoRMATIoN

Selecting SySTem InFoRmaTIon, all the information relating to the sterilizer settings is displa-yed.

OK

USB management

System information

FW version:Serial number:Language:Standby mode:Print:H2O filling:

49

APPENDIX – TECHNICAL CHARACTERISTICS

SUMMARy TABLE

device

Steam SterilizerClassification (according to the directive 93/42/eeC and subsequent changes)

B Classic-28

model II b

manufacturerCeFla s.c.

Via Selice prov.le 23/a 40026 Imola (bo) Italy

power supply voltage 120 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 1440 W (120 V~ 60 hz)

Insulation class Class I

Installation category Cat. II

environment of use Internal use

Sound power level (a weighted) < 65 db(a)

environmental operating conditionsTemperature: +15°C ÷ +35°C

Relative humidity: max 80%, non-condensing Altitude: max 3000 m (a.s.l.)

External dimensions (WxHxD) (excluding rear connections)

480 x 500 x 600 mm

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

about. 58 kgabout. 60 kg

about. 64 kg

Sterilization chamber dimensions (Ø x D)

280 x 450 mm

Sterilization chamber total volumeabout. 28 l

(0.028 m3)

Sterilization chamber useful volume (with tray supports inserted)

about. 19 l

(0.019 m3)distilled water tank capacity (supply)

about 5,5 l (water at max level) about 1 l (water at mIn level)

Sterilization programs 4 standard programs + 1 user-defined program

Test programsHelix/BD Test (only for B versions)

Vacuum Test Vacuum Test+Helix/BD Test (only for B versions)

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: male 1/8” npT connector

50

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.

51

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.

52

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, toothscalers);

– mineral-based articles;

– articles made of heat-resistant plastic;

– 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.

B Classic-28 model

Chamber Dimensions (Depth 450mm / Diameter 280mm / Volume 27.7 litres)

PRO

GR

AM

NA

ME

CYC

LE T

YPE

STER

ILIZ

ATI

ON

TE

MPE

RA

TUR

E A

ND

TIM

E

DR

YIN

G T

IME

(*)

TOTA

L C

YCLE

TI

ME

(AVE

RA

GE

LOA

D ÷

M

AX

LOA

D)

AVE

RA

GE

H2O

C

ON

SUM

PTIO

N

(ML

/CYC

LE)

AVE

RA

GE

ENER

GY

CO

NSU

MPT

ION

(K

WH

/CYC

LE)

MA

XIM

UM

LO

AD

(*

*) (*

**)

(C1) UNIVERSAL

134

PREVACUUM (3 steps; -0.8

bar each step)

134°C / 273°F

4 minutes 14.5 min 58÷61 859 0,8

5 kg unwrapped metal or polymer instruments and dental handpieces (max 0.9 kg per tray)

2.5kg single package metal or polymer instruments and dental handpieces (max 0.9 kg per tray)

1.5kg double package metal or polymer instruments and dental handpieces (max 0.9 kg per tray) 1 kg unwrapped porous and fabric textiles

0.75 kg single package porous and fabric textiles 0.6kg double package porous and fabric textiles

(C2) UNIVERSAL

121

PREVACUUM (3 steps; -0.8

bar each step)

121°C / 250°F

20 minutes 14.5 min 70÷73 890 0,9

5 kg unwrapped metal or polymer instruments and dental handpieces (max 0.9kg per tray)

2.5kg single package metal or polymer instruments and dental handpieces (max 0.9kg per tray)

1.5kg double package metal or polymer instruments and dental handpieces (max 0.9kg per tray) 1 kg unwrapped porous and fabric textiles

0.75 kg single package porous and fabric textiles 0.6kg double package porous and fabric textiles

(C4) SOLID 134

PREVACUUM (1 step; -0.8

bar)

134°C / 273°F

4 minutes 14.5 min 43÷46 477 0,7

5 kg unwrapped metal or polymer instruments (max 0.9kg per tray)

2.5kg single package metal or polymer instruments (max 0.9kg per tray)

(C5) HOLLOW

134

PREVACUUM (3 steps; -0.8

bar each step)

134°C / 273°F

4 minutes 3 min 47÷50 890 0,8 5 kg unwrapped metal or polymer instruments

(max 0.9kg per tray)

HELIX/BD TEST

PREVACUUM (3 steps; -0.8

bar each step)

134°C / 273°F

3.5 minutes 1.5 min 44 / / Test device only (without another load)

VACUUM TEST

Vacuum (-0.8 bar) / / 20 / /

Empty chamber Vacuum -0.8 bar

Test Time: 27 min VACUUM + HELIX/BD TEST (****)

/ / / 66 / / /

(*) Default drying time, but the drying time can be manually increased

(**) Cycles C1 and C2 are validated to sterilize up to 6 single sided lumened devices no longer than 118 mm and no smaller than 0.8 mm(corresponding to “hollow A” cavities with a length/diameter (L/D) ratio = 1 ≤ L/D ≤ 750). Cycles C4 and C5 are validated to sterilize up to 6 double sided lumened devices no longer than 115 mm and no smaller than 10 mm .

(***) If the material is sterilized “unwrapped” the sterilized material shall used immediately after sterilization (the cycle shall be considered as immediate use cycle)

(****) This program enables to execute, in sequence, Vacuum test and Helix/BD test (nevertheless each test is executed separately)

PROGRAM SUMMARy TABLE

120 V~ 60 hz

61

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

0.00

1.00

1.10

Pressure (bar)

Time (min)

LONG DRYING

PROCESS

FRACTIONATED PRE-VACUUM

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

-0.80

62

PROGRAM134°C - HOLLOW134°C - 4'00''

Pressure (bar)

0.00

1.00

2.00

2.10

-1.00

Time (min)

SHORT DRYING

PROCESS

FRACTIONATED PRE-VACUUM

-0.80

PROGRAM134°C - WRAPPED134°C - 4'00''

Pressure (bar)

0.00

1.00

2.00

2.10

-1.00

Time (min)

LONG DRYING

PROCESS

ONE SHOT PRE-VACUUM

63

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

(ONLY FOR B VERSIONS)

64

ExAMPLES OF PRINTED REPORTS(WITh opTIonal pRInTeR)

65

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 COMPONENTSoR 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

Message

Clean the dust filter

Replace the bacteriological filter

OK

66

WaRnInG meSSaGeboIleR FIlTeR CleanInGdooR loCk lubRICaTIon

duST FIlTeR CleanInG

baCTeRIoloGICal FIlTeR ReplaCemenT

WaTeR Tank CleanInGboIleR GaSkeT ReplaCemenT

GeneRal SeRVICe

NOTETo aChIeVe The beST peRFoRmanCe oF The deVICe, ReGulaR maIn-TenanCe muST be CaRRIed ouT on a ReGulaR baSIS.peRIodICally a meSSaGe WIll be dISplayed RequeSTInG ThaT The aboVe maInTenanCe CheCkS be peRFoRmed. FoR FuRTheR InFoRmaTIon oR In CaSe oF doubT, ConTaCT The TeChnICal SeRVICe: IF They haVe peRFoRmed ReGulaR maInTe-nanCe on The deVICe, The TeChnICIan mIGhT haVe alReady CaR-RIed ouT Some oF TheSe opeRaTIonS (example: baCTeRIoloGICal FIlTeR oR GaSkeT ReplaCemenT).

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.

67

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

68

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.

using a clean cloth, remove any residues from the bushing and the screw.Lubricate the inside of the bushing on the sterilizer door with a film of the silicon-based greaseprovided (as shown in the figure).

NOTEpuT on SInGle-uSe GloVeS beFoRe applICaTIon.eSSenTIally, The lubRICanT IS noT IRRITanT To The SkIn; neVeR-TheleSS, IT may CauSe unpleaSanT eFFeCTS IF IT aCCIdenTally ComeS InTo ConTaCT WITh The eyeS.In CaSe oF ConTaCT WITh The eyeS, RInSe WITh abundanT WaTeR.

Boiler filter cleaning

Door lock lubrication

B

A

D

CC

69

Water tank cleaning

Boiler gasket replacement

empty the tanks (C) containing the autoclave feedwater and wastewater, remove any deposits around the filter (D) on the bottom of the tank (see figure).After removing and cleaning the filter, wipe the inside of the tanks with a dry cloth and clean thoroughly.

When cleaning is complete, refit the filter in the tank.

NOTEdo noT uSe CleanInG pRoduCTS InSIde The Tank. uSe a dRy CloTh only.

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

Replace the bacteriological filter

Dust filter cleaning (ONLY FOR B VERSIONS)

Remove the dust filter (A) from the lower part of the autoclave, thoroughly rinse it with water and dry it before refitting it.

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.

70

PERIODIC STERILIzER VALIDATION

DISPOSAL ATEND-OF-LIFE

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 2011/65/EU, 2012/19/UE and 2004/108/CE, 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.

71

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.

72

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”).

73

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

ALARMINTERVENTION

Alarm during a cycle

74

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.

Min water levelError E030

Warning

RESET

Warning

Min water levelError E030

SYSTEM RESET

75

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

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CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE

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

A121 Reference heating element acquisition chain fault

ReFeRenCe heaTInG elemenT FaulT 1

A122 Reference heating element acquisition chain fault

ReFeRenCe heaTInG elemenT FaulT 1

A123 Reference heating element acquisition chain fault

ReFeRenCe heaTInG elemenT FaulT 1

A124 Reference heating element acquisition chain fault

ReFeRenCe heaTInG elemenT FaulT 1

A125 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

1 = ok (warning)2 = ok + door unlocking + ReSeT

77

CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE

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

A360 Vacuum pulsation during drying not executed within timeout TIme ouT ppd 2

1 = ok (warning)2 = ok + door unlocking + ReSeT

78

CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE

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 Failure FlaSh memoRy noT aCCeSSIble 3

S002 Flash memory full FlaSh Full 3

S005 uSb key Failure uSb STICk noT aCCeSSIble 3

S006 uSb stick not accessible uSb STICk noT aCCeSSIble 3

S007 uSb stick full uSb STICk Full 3

S009 printer not connected no pRInTeR 2

S010 printer: there is no paper or there might be a configuration error pRInTeR: no papeR 2

S011 printer cover open pRInTeR: dooR open 2

S012 Probable printer configuration error pRInTeR noT Ready 2

1 = ok (warning)2 = ok + door unlocking + ReSeT

79

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).

80

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.

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

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.

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

81

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

Contact Technical Service (see Appendix).

A120 Reference heating element acquisition chain fault

A121 Reference heating element acquisition chain fault

A122 Reference heating element acquisition chain fault

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

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.

82

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

A123 Reference heating element acquisition chain fault

Contact Technical Service (see Appendix).

A125 Reference heating element acquisition chain fault

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.

Contact Technical Service (see Appendix).

problem in the hydraulic circuit.

Steam generator safety thermostat inter-vened.

Steam generator malfunction

83

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

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).

problem in the hydraulic circuit.

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

Steam generator malfunction

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

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

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).

problem in the hydraulic circuit.

A 254

Water injection pump malfunction.

Contact Technical Service (see Appendix).

problem in the hydraulic circuit.

Steam generator safety thermostat intervened.

Steam generator malfunction

84

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

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).

problem in the hydraulic circuit.

Contact Technical Service (see Appendix).

Steam generator safety thermostat intervened.

Steam generator malfunction

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

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

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

Water injection pump malfunction.

Contact Technical Service (see Appendix).

problem in the hydraulic circuit.

Steam generator safety thermostat intervened.

Steam generator malfunction

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).

85

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

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").

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

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

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

A 360Drain filter obstructed. Clean the drain filter (see Appendix: “Maintenance").

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

86

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

H 150 pressure sensor (mpx) failure.

Contact Technical Service (see Appendix).

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.

problem in the hydraulic circuit.

H 403Steam generator malfunction.

problem in the hydraulic circuit.

H 404problem in the hydraulic circuit.

Steam generator malfunction.

H 405

problem in the hydraulic circuit.

Steam generator malfunction.

H 406

problem in the hydraulic circuit.

Steam generator malfunction.

H 410 Timer problem

H 990 General operating problem.

H 991 General operating problem.

H 992 General operating problem.

H 993 General operating problem.

HAZARDS (category H)

87

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

S001 Flash memory Failure

Contact Technical Service (see Appendix).

S002 Flash Full

S005 uSb key Failure

S006 uSb Stick not accessible

S007 uSb stick full

S009 no pRInTeR

S010 pRInTeR: no papeR

S011 pRInTeR: dooR open

S012 pRInTeR noT Ready

SYSTEM ERRORS (category S)

88

APPENDIX – ADMIN USER PIN RESET

IF The admIn uSeR enTeRS The pIn InCoRReCTly ThRee TImeS, The nexT TIme The pIn IS RequeSTed, The FolloWInG unloCkInG Code needS To be enTeRed:

9999

In Table below are listed all the labels of the Family of Steam Sterilizer B 28 series, their content and their position.

Label

Position (refer to the red circle) Label content

(note: this is the back of the autoclave)

- manufacturer name and address

-manufacturer model

-reference number

-serial number

-power information

-pressure

-chamber volume

-Fuse information

-manufacturing date

- CE Mark symbol

- Read instruction symbols

-European Disposal symbol

APPENDIX – LABELING

Label

Position (refer to the red circle) Label content

(note: this is the back of the autoclave)

- Indication for water inlet connector (connection for automatic distilled water filling ).

-Indication for water drain connector (Connection for “direct water drainage”).

Label

Position (refer to the red circle) Label content

(note: this is the back of the autoclave)

- Indication for WI-FI (only for B FUTURA-28 model)

Label

Position (refer to the red circle) Label content

Note: this is the side of the autoclave

Label of pressure vessel This label contains the following information: - Manufacturer - Serial Number of the vessel -Reference to ASME standard -Min-Max Pressure -Max Temperature -Vessel Volume -Test Pressure

Label

Position (refer to the red circle) Label content

Note: this is the front of the autoclave with the door opened

- Caution about hot surface (laser marked label)

Label

Position (refer to the red circle) Label content

Note: this is the front of the autoclave with the door opened

- Distilled water tank drain quick coupling – Quick connector Service only (laser marked label)

-Distilled water top up quick coupling

Label

Position (refer to the red circle) Label content

Note: this is the front of the autoclave with the door opened

- Used water drain quick connector (laser marked label)

Label

Position (refer to the red circle) Label content

Note: this is the front of the autoclave with the door opened

- Caution about read the instruction for use (laser marked label)

-Caution about lubrication of door lock

Label

Position (refer to the red circle) Label content

Note: this is the water reservoir

- Caution about possibility of hot water in the reservoir (printed label on plastic)

89

APPENDIX – ACCESSORIES

PURE 100 PURE 500

AUTOMATIC FILLING FRONT FILLING

PRINTER

For management of the automatic filling accessories, refer to the previous section WATER FILLING and to the accessory manual.THE ABOVE MENTIONED ACCESSORIES ARE AVAILABLE FOR B VERSIONS ONLY.

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

H2O AUXILIARY SOLENOID VALVE

90

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.

91

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:

www.mocom.it