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classic

Family of Steam sterilizers B28 series - B CLASSIC models:


B Classic-28

Operating instructions
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 CONTENTS
INTRODUCTION.....................................................................................................................................1
Symbols used in the manual................................................................................................................................ 1
Symbols on equipment........................................................................................................................................... 1
APPLICABLE EUROPEAN DIRECTIVES............................................................................................................................. 1
intended use.................................................................................................................................................................... 1
Important notes.......................................................................................................................................................2
PURPOSE OF THE MANUAL .............................................................................................................................................. 2
GENERAL WARNINGS......................................................................................................................................................... 2

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


Dimensions and weight................................................................................................................................................ 3
DESCRIPTION OF THE CONTENTS................................................................................................................................... 3
HANDLING THE PRODUCT................................................................................................................................................. 4

PRODUCT INTRODUCTION..................................................................................................................5
Introduction................................................................................................................................................................... 5
General Characteristics........................................................................................................................................... 5
FRONT................................................................................................................................................................................... 6
REAR .................................................................................................................................................................................... 7
LCD ICONS........................................................................................................................................................................... 8
Operating cycle example........................................................................................................................................... 9

INSTALLATION.....................................................................................................................................10
Introduction................................................................................................................................................................. 10
Compartment dimensions for built-in installations..................................................................................... 10
General installation precautions ...................................................................................................................... 11
Electrical Connections........................................................................................................................................... 11
DIRECT CONNECTION TO A CENTRALized DRAINing point..................................................................................... 12

FIRST START-UP.................................................................................................................................13
Turning on the equipment........................................................................................................................................ 13
MAIN MENU ....................................................................................................................................................................... 14
Filling distilled water ............................................................................................................................................. 15
Manual filling..........................................................................................................................................................15
Automatic filling....................................................................................................................................................15

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

PREPARING THE MATERIAL..............................................................................................................29


Introduction................................................................................................................................................................. 29
Treating the material before sterilization..................................................................................................... 29
arranging the............................................................................................................................................................... 30
load................................................................................................................................................................................... 30

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

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

I
PROGRAMMED STARTING.................................................................................................................35
RUNNING THE CYCLE....................................................................................................................................................... 36
RESULT OF THE cycle.................................................................................................................................................... 36
DOOR OPENING AT CYCLE END...................................................................................................................................... 36
MATERIAL STORAGE......................................................................................................................................................... 37

TEST PROGRAMS...............................................................................................................................38
Introduction................................................................................................................................................................. 38
cycle Helix Test/B&D (ONLY FOR B VERSIONS)...................................................................................................... 38
cycle VACUUM TEST...................................................................................................................................................... 40
VACUUM TEST + Helix Test/B&D cycle (ONLY FOR B VERSIONS)......................................................................... 41
H2O TEST (ONLY FOR B VERSIONS)............................................................................................................................... 41
DOOR OPENING................................................................................................................................................................ 42
USED WATER DRAIN......................................................................................................................................................... 43
Detaching the pipe.................................................................................................................................................43
MANUAL INTERRUPTION ................................................................................................................................................. 44

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

APPendix – Technical Characteristics................................................................................49


SUMMARY TABLE.............................................................................................................................................................. 49
Safety Devices.............................................................................................................................................................. 50
Water supply characteristics.............................................................................................................................. 51

APPENDIX – PROGRAMS...................................................................................................................52
INTRODUCTION................................................................................................................................................................. 52
pRoGRam SummaRy Table b ClaSSIC-28
120 V~ 60 Hz....................................................................................................................................................................... 60
STERILIZATION PROGRAM DIAGRAM............................................................................................................................. 61
DIAGRAMS of THE TEST PROGRAMMES...................................................................................................................... 63
EXAMPLES OF PRINTED REPORTS................................................................................................................................ 64

APPENDIX – MAINTENANCE..............................................................................................................65
Introduction................................................................................................................................................................. 65
Ordinary Maintenance Program........................................................................................................................... 65
Scheduled Maintenance Messages................................................................................................................. 65
Maintenance Description ........................................................................................................................................ 67

IIII
Clean gasket and porthole.............................................................................................................................. 67
Clean external surfaces................................................................................................................................... 67
Clean sterilization chamber and accessories ........................................................................................ 67
Disinfect external surfaces............................................................................................................................ 67
Boiler filter cleaning......................................................................................................................................... 68
Door lock lubrication......................................................................................................................................... 68
Dust filter cleaning (ONLY FOR B VERSIONS)................................................................................................ 69
Replace the bacteriological filter.............................................................................................................. 69
Water tank cleaning............................................................................................................................................. 69
Boiler gasket replacement.............................................................................................................................. 69
Periodic sterilizer validation................................................................................................................................ 70
DISPOSAL at end-of-life.............................................................................................................................................. 70

APPENDIX – GENERAL PROBLEMS.................................................................................................71


Introduction................................................................................................................................................................. 71
Analysis and resolution of problems................................................................................................................ 71

APPENDIX – alarms.........................................................................................................................73
Introduction................................................................................................................................................................. 73
alarm intervention..................................................................................................................................................... 73
Alarm during a cycle............................................................................................................................................ 73

System reset...................................................................................................................................74
Alarm Codes................................................................................................................................................................... 75
Analysis and resolution of problems................................................................................................................ 79

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

APPENDIX – ACCESSORIES..............................................................................................................89
PRINTER CONNECTION.............................................................................................................................................. 90

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

III
This manual describes all procedures for the correct use of the device and instructions for deri-
INTRODUCTION 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.
NOTE
pay SpeCIal aTTenTIon To paRaGRaphS IndICaTed by The poInTInG
FInGeR.
Symbols used in the
manual WARNING
ThIS Symbol IndICaTeS a poTenTIal danGeR oF InjuRy. FolloW
The pRoCeduReS deSCRIbed In The manual To aVoId InjuRInG
The uSeR and/oR oTheRS.

DANGER
ThIS Symbol IndICaTeS a poTenTIal danGeR oF pRopeRTy damaGe.
FolloWS The InSTRuCTIonS In The manual To pReVenT poTenTIal
damaGe To maTeRIalS, equIpmenT oR oTheR pRopeRTy.

DANGER
ThIS Symbol IndICaTeS a poTenTIal danGeR due To hIGh TempeRa-
TuRe.

Symbols on
equipment 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:
APPLICABLE 2006/95/CE, for the approximation to the legislation of the Members States related to low vol-
tage equipment.
EUROPEAN
DIRECTIVES 2004/108/CE, for the approximation to the legislation of the Members States related to the elec-
tromagnetic compatibility;
93/42CEE and subsequent changes, concerning the medical devices.

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

INDICATION The Family of steam Sterilizers B 28 series are table top steam sterilizers to be used in medical
FOR USE 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.

WARNING
The deVICe muST only be uSed by qualIFIed peRSonnel. IT may
noT be uSed oR handled by InexpeRT and/oR unauThoRIzed
peRSonnel FoR any ReaSon.

WARNING

The STeRIlIzeR IS noT a mobIle oR poRTable deVICe.

1
Important notes
NOTE
THE MANUAL INFORMATION ARE SUBJECT TO CHANGES WITHOUT ANY
NOTICE.
THE MANUFACTURER IS NOT RESPONSIBLE FOR DIRECT, INDIRECT OR
ACCIDENTAL DAMAGE RESULTING FROM OR RELATING TO THE PROVI-
SION OR USE OF THIS INFORMATION.
THIS DOCUMENT MAY NOT BE REPRODUCED, ADAPTED OR TRANSLA-
TED, IN PART OR IN FULL, WITHOUT THE PRIOR WRITTEN PERMISSION
OF THE MANUFACTURER.

PURPOSE OF The purpose of this manual is to provide instructions for:


THE MANUAL
–– becoming generally familiar with the product;
–– its correct installation and configuration;
–– its safe, efficient use;
–– handling materials before and after sterilization.
Its APPENDIXs also provide:
–– the product's general technical specifications;
–– sterilization program specifications;
–– maintenance;
–– troubleshooting;
–– a variety of other documentation.

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

WARNING
The user is responsible for all legal requirements related
to the installation and use of this product. The manufactu-
rer will not be responsible for any breakage, malfunctions,
property damage or injury in the event that the product is
not installed or used correctly.

Please observe the following precautions in order to avoid injury or property damage:
–– Use ONLY high-quality demineralised and/or distilled water.

WARNING
The use of water of inadequate quality can severely damage
the device.
See Appendix Technical Characteristics in this regard.

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


–– Do not pour inflammable substances on the device;
–– Do not use the device in the presence of gas or explosive or inflammable vapors;
–– Before performing any maintenance or cleaning, ALWAYS DISCONNECT the electricity.

DANGER
Whenever it is not possible to disconnect the electricity to
the device, or if the external power grid switch is far away
or, at any rate, not visible to the maintainer, place a WORK IN
PROGRESS sign on the external power grid switch after tur-
ning it OFF.

–– Make sure the electrical system is grounded conforming to current laws and/or standards;
–– Do not remove any label or nameplate from the device; request new ones, if necessary.
–– Use only original replacement parts.

WARNING
The failure to observe the above, releases the manufactu-
rer from all liability.

2
CONTENTS OF NOTE
THE PACKAGE CHECK THE INTEGRITY OF THE
PACKAGE UPON RECEIPT.
Dimensions Once the package is opened, check that:
and weight –– the supply matches the specifications of the order A
(see the accompanying document);
–– that there is no obvious product damage;

Dimensions and weight


B C
A. Height 600 mm
B. Width 600 mm
C. Depth 700 mm
Total weight 65 kg

NOTE
IN 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.

DESCRIPTION OF
THE CONTENTS

1 5
7
4 9
8

2 10
3

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.

3
HANDLING THE In the case of manual handling, the product must be lifted by two persons using the handles cut
PRODUCT 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.

WARNING
We recommend that the device be transported and stored
at a temperature no lower than 5 °C. Prolonged exposure to
low temperature an damage the product.

NOTE
KEEP THE ORIGINAL PACKAGING AND USE IT WHENEVER THE DEVICE IS
TO BE TRANSPORTED. THE USE OF DIFFERENT PACKAGING COULD DA-
MAGE THE PRODUCT DURING SHIPMENT.

DANGER
Before transport, leave the device turned-off for about 30
minutes after the last program finishes and drain the distil-
led water and used water tanks so that the all the hot inter-
nal parts will have time to cool.

CONDITIONS FOR
STORAGE AND
TRANSPORT
TEMPERATURE: between +5° C and +70° C

HUMIDITY: between 20% and 80%

PRESSURE: between 50 and 110 kPa

4
PRODUCT
INTRODUCTION
Introduction 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
General micro-processor with a large, printed stainless steel sterilisation chamber.
Characteristics
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.

NOTE
For the description of the safety devices, refer to the Appen-
dix Technical Characteristics.

5
FRONT

LCD display and con-


trol panel

Door

On/Off switch

Dust filter
(ONLY FOR B
VERSIONS)

Sterilization chamber

Bacteriological filter

Door closing system

Water drain filter

Distilled water top-up quick-cou-


pling (ONLY FOR B VERSIONS)

distilled water tank drain quick-


coupling
Quick connector Service only (laser
marked label)

Used water drain quick connector

Door

6
REAR

Rear spacer fastening


slots

Heat exchanger

Connection for direct water


(water drain connector)

Connection for automatic distilled


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

Data label
Serial cable connection

Automatic filling electrical connection


(ONLY FOR B VERSIONS)

Mains fuses

Power cable connection

7
LCD ICONS

DATE TIME

11/04/13 10:54

OK
SELECTION
ICONS

DOOR OPENING

DECREASE INCREASE CONFIRMATION


BUTTON BUTTON BUTTON

11/04/13 10:54

Selection of the sterilizer settings (SETUP)

11/04/13 10:54

Selection for data management

11/04/13 10:54

Sterilization cycle selection

11/04/13 10:54

Selection of the test cycles

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

8
Operating cycle The Classic series sterilisation programme can be effectively described as a succession of pha-
example 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.

P res s ure (bar)

P R OC E SS
2.10

2.00

1.00

Time (min)
0.00

-0.80

SINGLE VACUUM PULSE VACUUM DRYING

NOTE
PLEASE REFER TO APPENDIX PROGRAMS FOR MORE DETAIL.

9
INSTALLATION 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,
Introduction please follow the instructions in this chapter scrupulously.

NOTE
CUSTOMER SUPPORT (SEE APPENDIX) WILL ANSWER YOUR QUESTIONS
AND PROVIDE ADDITIONAL INFORMATION.
THE STERILIZER HAS PASSED ALL REQUIRED INSPECTIONS BEFORE
BEING PLACED ON THE MARKET. IT DOES NOT REQUIRE ANY ADDITIONAL
CALIBRATION BEFORE BEING PLACED IN SERVICE.

Dimensions and
weight
A. Height (total) 500 mm B

B. Width (total) 480 mm A


C. Depth (excluding
600 mm
rear connections)
60
Total weight
kg C

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.

Compartment When installing the sterilizer inside a cabinet, you must


dimensions provide adequate space all around the device to pro- B
vide effective ventilation as well as a large enough
for built-in opening in the back that, in addition to allowing the
installations passage of the power cord will also provide an ade-
quate air flow and the consequent optimum cooling
of the heat exchanger. A

The compartment where the steriliser will be kept must


have the following minimum dimensions:

Dimensions
A. Height 500 mm with FRONT FILLING KIT
670 mm with FILLING FROM THE TOP (door)
B. Width 600 mm

WARNING
Compartment dimensions less than those shown may com-
promise the correct circulation of air around the device
and may not provide adequate cooling, with the consequent
deterioration of performance and/or possible damage.

NOTE
IF THE FILLING AND DRAINAGE DOORS ARE NOT ACCESSIBLE FROM THE
TOP AFTER THE DEVICE HAS BEEN BUILT IN, IT IS ADVISABLE TO USE THE
FRONT ATTACHMENTS (FRONT FILLING KIT).
IF THE MAIN SWITCH IS INACCESSIBLE WHEN INSTALLED IN THE COM-
PARTMENT, USE AN ELECTRIC PLUG THAT INCORPORATES AN ON/OFF
SWITCH.
DO NOT REMOVE THE UPPER COVER OR ANY OTHER EXTERNAL PART.
WHEN INSTALLED IN THE COMPARTMENT, THE DEVICE MUST BE COM-
PLETE WITH ALL ITS PARTS.
PLEASE REFER TO APPENDIX TECHNICAL CHARACTERISTICS FOR COM-
PLETE TECHNICAL DATA.

10
General Obey the following warnings for the correct operation of the device and/or to avoid risky situa-
installation tions:
precautions –– Install the sterilizer on a flat and perfectly horizontal surface.
–– Make sure that the support surface is strong enough to support the equipment weight (about
60 kg);
–– Leave adequate space for ventilation (at least 10 cm on each side) all around the sterilizer,
especially in back.
–– If the device is built-in to a cabinet, be sure to respect the warnings in the preceding paragraph,
avoiding an obstructions to the air intake;
–– Do not install the sterilizer near tubs, sinks or similar places, to avoid contact with water or
liquids. This could cause short circuits and/or potentially dangerous situations for the operator;
–– Do not install the sterilizer in a place that is excessively humid or poorly ventilated;
–– Do not install the machine were there is gas or inflammable and/or explosive vapors;
–– Install the device so that the power cord is not bent or crushed. It must run freely all the way
to the socket.
–– Install the device that any external fill/drain tubing is not bent or crushed. They must run freely
to the drain tank.

Electrical The sterilizer's must be connected to a socket of the electrical system of adequate capacity for
Connections the device's absorption and ground provided, in conformity with current laws and/or standards.
The socket must be suitably protected by a breaker having the following characteristics:

–– Nominal current In 16 A
–– Differential current IDn 0,03 A

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

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

11
DIRECT CONNECTION –– Remove the cap holding clip on the rear of the autoclave.
TO A CENTRALized –– Fit the plastic tube on the elbow union (provided).
DRAINing point –– 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.

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

The following diagram provides an indicative arrangement of the components:

Drain
siphon

Support
plane
Clamp
To the centralized
draining point

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

NOTE
FOR AUTOMATIC FILLING SYSTEMS (PUMP, 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.

12
FIRST START-UP

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

WARNING

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

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

13
MAIN MENU Once the start procedure has been completed, the main menu shown below appears on the
display.

11/04/13 10:54

OK

The device waits for selection of the desired program (see section “Program Selection”).

DANGER

To prevent burns, be careful not to touch the steriliza-


tion chamber, the chamber equipment or the inside of the
door with bare hands.

14
Filling distilled The first time the sterilizer is used, and later when the MIN water level indicator comes on, you will
water have to fill, or top-off, the internal distilled water tank.

Open the loading door.

Manual filling 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.

BEEP

WARNING
THE 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.

Automatic filling Refer to the Appendix "ACCESSORIES".

15
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.

NOTE
uSe The SeTup pRoGRam WheneVeR neCeSSaRy. a CoRReCTly peR-
SonalIzed deVICe pRoVIdeS The beST peRFoRmanCe and The moST
SaTISFaCToRy uSe.
CuSTomeR SuppoRT (See appendIx) IS aVaIlable To help uSeRS by
pRoVIdInG SuGGeSTIonS oR adVICe on The beST Way To uSeS The
opTIonS In The SeTup pRoGRam.

WARNING
THE 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).

WARNING
THE 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.

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

11/04/13 10:54

OK

LANGUAGE

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

Language

Date and Time

Users
OK

English

Italian
Spanish
OK

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

16
DATE AND TIME

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

Language

Date and Time

Users
OK

DD MM YYYY
12 / 04 / 2013

±hh hh mm ss
+1 11 : 34 : 15
OK

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

DD MM YYYY
12 / 04 / 2013

±hh hh mm ss
+1 11 : 34 : 15
OK

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


Confirm with OK and continue with modifying the other fields.
Press the EXIT icon to save the selections made and go back to the previous menu.

17
USERS

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

Date and Time

Users

OK

Enter the PIN of the system administrator (Admin), selecting a 4-digit numerical code.

Admin
PIN

1---
OK

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

PIN change

User list

PIN request
OK

and then "Create new user"

Create new user

User 1
OK

18
New user

----
OK

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.

New user

VE--
OK

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

Vero
PIN

7---
OK

Vero
PIN

7145
OK

Create new user

*Admin

Vero
OK

19
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

PIN change
OK

USER DATA

Vero

User creation date: 15/04/2013


Cycles launched/completed: 102/101

ADMIN users, on the other hand, have the following rights:


PIN change: they can change its PIN
User list
PIN request
User deletion

PIN change

User list
OK

PIN request

Delete user

OK

20
PIN CHANGE by ADMINISTRATOR.

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

PIN change

User list
OK

Enter the current PIN.

User 1
Current PIN

----
OK

Enter the new PIN.

User 1
New PIN

----
OK

NOTE
IF 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.

21
USER LIST.
Select the option shown below and confirm with the OK button.

PIN change

User list

PIN request
OK

*Admin

User 2

User 3
OK

User 2

User creation date: 15/04/2013


Cycles launched/completed: 102/101

Select the desired user. Pressing OK you access the page with the data relating to the user
selected.

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

User list

PIN request

Delete users
OK

X Cycle start

Cycle End
OK

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.

X Cycle start
22 Cycle End
OK
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.

134°C Universal B
4’ 134°C

49’ 2.12 Bar

User 1
User 2
User 3 OK

User 1
PIN

---- OK

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

134°C Univ. 134°C

Warming up 2.12 Bar

39:00 4’

23
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.

134°C Univ. 60°C

Completed 1.12 Bar

00:00 0’

134°C Univ. 4’

max 134,7°C max 2.12 Bar


min 134,3°C min 2,01 Bar

OK

Pressing OK, the user confirms the positive outcome of the


cycle and authorises taking delivery of the sterilized mate-
rial.

User 1
User 2
User 3
OK

User 1
PIN

----
OK

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

24
DELETE USERS.
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.

PIN request

Delete users

OK

User 2

User 3
OK

User 2

Do you confirm deletion ?

OK

25
STANDBY
Select the STANDBY option and confirm by pressing the OK button.

Users

Standby
Water filling
OK

Standby

Status ON
Interval 10’

OK

Standby

Status ON
Interval 10’

OK

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


Confirm by pressing OK.

26
Water filling

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

Standby

Water filling
Screen
OK

Pure 100

Pure 500

External pump
OK

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

NOTE
ONLY FOR B VERSIONS
When the automatic filling system is connected, the steri-
lizer asks you to identify the type of device actually con-
nected by pressing the corresponding button.
If the filling system is connected when the sterilizer is off,
access the menu via the configuration program and manually
select the correct option.

NOTE
This menu can also be used to temporarily deactivate the au-
tomatic filling system (filters exhausted, faulty, etc.) and go
to manual tank filling.

External pump

Manual filling

OK

Select "Manual filling" and confirm with OK.

27
SCREEN

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

Water filling

Screen
Service
OK

Screen

Brightness 100%
Contrast 5%

OK

Screen

Brightness 100%
Contrast 5%

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.

SERVICE

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

Screen

Service

OK

28
PREPARING THE First of all, it should be recalled that, when handling and managing contaminated material, it is
a good idea to take the following precautions:
MATERIAL
–– Wear rubber gloves of adequate thickness;
–– Clean your gloved hands with a germicide detergent;
Introduction
–– Always carry the instruments on a tray;
–– Never carry them in your hands;
–– Protect your hands from contact with any sharp points or edges; this will avoid the risk of
contracting a dangerous infection;
–– Immediately remove any article that does not need to be sterilized or that is not capable of
withstanding the process;
–– Carefully wash your still gloved hands when done handling non-sterile material.
All materials and/or instruments to be sterilized must be perfectly clean, without any type of re-
sidue (deposits of organic/inorganic material, fragments of paper, cotton/gauze pads, lime, etc.).

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

Treating the An effective cleaning consists of the following:


material before 1. Rinse the instruments under running water immediately after use;
sterilization
2. Separate metal instruments by type of material (carbon steel, stainless steel, brass, aluminum,
chromium, etc.), to avoid electrolytic oxidation-reduction;
3. Clean the instrument with an ultrasound device containing a mixture of water and germicide solution
carefully following the manufacturer’s recommendations, or use a heat disinfector;
4. For best results, use a detergent specifically designed for ultrasound washing, with a neutral pH.

NOTE
SOLUTIONS CONTAINING PHENOLS OR QUATERNARY AMMONIA COM-
POUNDS CAN CAUSE CORROSION ON INSTRUMENTS AND THE METAL
PARTS OF ULTRASOUND DEVICES.
5. After washing, carefully rinse the instruments and make sure that residues have been completely
eliminated; if necessary, repeat the washing cycle or clean manually.

NOTE
TO AVOID THE FORMATION OF LIME SPOTS, RINSE WITH DEIONIZED OR
DISTILLED WATER, IF POSSIBLE. WHENEVER VERY HARD TAP WATER IS
USED, WE RECOMMEND ALWAYS DRYING THE INSTRUMENTS.

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

NOTE
THE 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.

WARNING
CONSULT THE INSTRUCTIONS PROVIDED BY THE MANUFACTURER OF
THE INSTRUMENT/MATERIAL TO BE STERILIZED BEFORE SUBJECTING
IT TO AUTOCLAVE TREATMENT, CHECKING FOR ANY INCOMPATIBILITIES.
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.

29
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.

NOTE
DO NOT USE DETERGENTS WITH A HIGH CONTENT OF CHLORINE AND/
OR PHOSPHATES. DO NOT BLEACH WITH CHLORINE-BASED PRODUCTS.
THESE SUBSTANCES CAN DAMAGE THE TRAY SUPPORTS, TRAYS AND
ANY METAL INSTRUMENTS THAT MAY BE PRESENT IN THE STERILIZA-
TION CHAMBER.

arranging the Follow the instructions below for the most efficient sterilization process, preserve the material and
increase its useful life.
load
General notes for positioning on trays:

–– Arrange instruments made of different metals (stainless steel, tempered steel, aluminum, etc.)
on different trays or well separated from each other;
–– In the case of instruments not made of stainless steel, place a paper sterilization napkin or a
muslin cloth between the tray and the tool, avoiding direct contact between the two different
materials;
–– In any case, arrange the objects sufficiently distant from each other that they will remain so for
the entire sterilization cycle;
–– Make sure that all instruments are sterilized in an open position;
–– Position cutting instruments, (scissors, scalpels, etc.) so they can not come into contact with
OK each other during sterilization; if necessary, use a cotton or gauze cloth to isolate and protect
them;
–– Arrange recipients (glasses, cups, test tubes, etc.) resting on their side, or upended, so avoid
pooling water;
– Do not load trays beyond their indicated limit (see Appendix A).
–– 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.
OK

NOTE
PLACE A CHEMICAL STERILIZATION INDICATOR ON EVERY TRAY TO IN-
DICATE THAT THE PROCESS HAS OCCURRED: THIS AVOIDS USELESSLY
REPROCESSING THE SAME LOAD OR, WORSE, USING NON-STERILIZED
MATERIAL. IF PROCESSING WRAPPED MATERIAL, PLACE THE INDICATOR
INSIDE ONE OF THE WRAPPINGS.

30
Notes for rubber and plastic tubing

OK – Always rinse before use with pyrogen-free water; do not dry them;
– Arrange the tubing on the tray so that their ends are not obstructed or crushed.
– Do not bend or wind them, but allow them to lie as straight as possible.

Notes for packets and packages

– Arrange packages side-by-side, suitably spaced and absolutely not piled, to avoid their co-
ming in contact with the walls of the chamber.
– Whenever it is necessary to wrap particular objects, always use suitably porous material (ste-
rilization paper, muslin napkins, etc.), closing the wrapping with autoclave adhesive tape.
OK

Notes for wrapped material

– Wrap instruments individually or, when more than one instrument are placed in the same
wrapping, make sure that they are made of the same metal;
– Seal the wrapping with adhesive tape for autoclaves or heat-sealing machines.
– Do not use staples, pins or other fasteners since they can compromise the maintenance of
sterility;
– Arrange the envelopes so as to avoid forming air pockets that obstruct the correct penetration
and removal of the steam.
OK
– Orient the envelopes so as to leave the plastic side up and the paper side down (tray side).
– In any case, check that they are correctly positioned, turning them over, if necessary.
– If possible, place the envelopes edgewise to the tray, with a suitable support.
–– Never superimpose envelopes on top of each other.

WARNING
WHENEVER YOU ANTICIPATE PROLONGED STORAGE, ALWAYS WRAP
THE INSTRUMENTS. SEE THE CHAPTER, “PRESERVING STERILIZED MA-
TERIAL”.

Program selection is fundamental for a successful sterilization process.

Since each instrument, or material in general, has different shape, consistency and properties, it
is important to identify the most suitable program for it, both for preserving its physical cha-
racteristics (avoiding or, at any rate, limiting alterations) as well to guarantee the most effective
sterilization.

A guide to selection of the program suited to the load is given in the Appendix Programs.

31
STERILIZATION A sterilization cycle consists of a determined number of phases. The number and duration of the
phases can differ for the programs, based on the type of air extraction, sterilization process and
CYCLES drying method.

The electronic control system monitors the various phases, at the same time checking that the
various parameters are respected; if any type of anomaly is encountered during the cycle, the
program is immediately interrupted, generating an alarm identified by a code, with a relative mes-
sage explaining the nature of the problem.

With this type of control, when you select a suitable sterilization program, you are guaranteed
perfect sterilization under any conditions.

After inserting the load in the sterilization chamber (taking the precautions described in the sec-
tion “Preparing the material to be sterilized”) , select the desired sterilization cycle as follows:

11/04/13 10:54

OK

134°C Universal B

121°C Universal B

134°C Hollow S
OK

134°C Solid S

User-defined

OK

32
USER-DEFINED CYCLE

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

134°C Solid S

User-defined

OK

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.

User-defined
6’ 134°C

53’ 2.12 Bar

Fractionated vacuum Yes


Temperature 134°C
Process Time 6’
Drying Time 4’
OK

SI
Fractionated vacuum Yes
134°C
Temperature 134°C
Process Time 6’
4’
Drying Time 4’
OK
OK

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

User-defined
6’ 134°C

53’ 2.12 Bar

Press to start the user-defined cycle.

33
EXTRA DRYING Select the EXTRA DRYING option by tapping the button indicated.
Act on the + and – buttons to set the time and confirm.
After confirmation, the extra drying time will appear next to the total cycle time.
The extra time stays in memory. To activate the extra drying function, press the OK button.

134°C Universal B
4’ 134°C

49’ 2.12 Bar

Drying Time

0 min

OK

Drying Time

30 min

OK

134°C Universal B
4’ 134°C

49’+30’ 2.12 Bar


01:30

34
PROGRAMMED Select the SCHEDULED START option by tapping the button indicated.
Act on the + and – buttons to set the time and confirm.
STARTING After confirmation, the time set is shown on the display. To activate delayed starting, press the
OK button.

134°C Universal B
4’ 134°C

49’ 2.12 Bar

Delay Start
16/04/13 - 12:58

00:00
OK

Delay Start
16/04/13 - 14:28

15:30
OK

134°C Universal B
4’ 134°C

49’+30’ 2.12 Bar


15:30

35
RUNNING THE CYCLE Press the OK button to start the cycle with the active options selected.

Taking as example the most complete and significant sterilization cycle, i.e. the 134°C UNIVER-
SAL program, characterised by fractionated pre-vacuum, the cycle sequence is as follows:
WARMING UP

134°C Univ. 134°C

Warming up 2.12 Bar

39:00 4’

FIRST VACUUM PHASE


FIRST PRESSURE RISE
134°C Univ.
SECOND VACUUM134°C
PHASE
134°C
SeCond Univ. 60°C
Warming up PRESSURE RISE
2.12 Bar
THIRD VACUUM1.12
Completed PHASE
Bar
39:00 4’
THIRD PRESSURE RISE
00:00 0’
STERILIZATION
STEAM DISCHARGE
DRYING
VENTILATION
CYCLE COMPLETION

134°C Univ. 60°C


Stampa etichette
Completed 1.12 Bar
N°etich.
00:00 0’20
Scadenza (gg) 10

NO OK

RESULT OF If the message "COMPLETED" appears, it means that the cycle has completed correctly without
any interruptions for alarms and that complete asepsis of the material is guaranteed.
THE cycle
Stampa etichette

DOOR OPENING N°etich.shown in 20


To open the sterilizer door, press the button the figure:
AT CYCLE END Scadenza (gg) 10

NO OK
134°C Univ. 60°C

Completed 1.12 Bar

00:00 0’

36
MATERIAL STORAGE The sterilized material must be adequately treated and stored to maintain its sterility over time,
until its use.

Inadequate storage can cause rapid recontamination.

This leads to problems regardless of what you do since you will either be using recontaminated
material (most of the time unconsciously), placing the user and patient at risk, or you will have to
run the sterilization cycle again, with an inevitable waste of time and resources.

For this reason, we think it will be useful to provide several basic suggestions, leaving the opera-
tor the task of further study of specific texts.

Assuming that the sterilizer is located in a clean place, free of dust and not too damp, the following
precautions should be taken when handling and/or carrying sterile material:

1. Remove the load from the sterilization chamber wearing gloves and a clean, or even better,
sterilized smock. As an additional precaution, wear a protective mask on your face;
2. Rest the tray on a dry, suitably clean and disinfected surface. Take care to distance or, at any
rate, separate the sterile material from the area where contaminated material is kept waiting
to be sterilized;
3. Touch the material and/or instruments as little as possible, taking extreme care not to cut or
damage the wrappings;
4. Let the instruments cool before any transport (and subsequent storage). If necessary for transport,
transfer the material using dry, clean and disinfected containers. The containers must be
closed or, if open, covered with clean cloths.

Sterile material waiting for used must be stored using the appropriate techniques. These will
significantly slow recontamination:

1. Store the material and/or instruments in the protective wrappings that were used during
sterilization. Do not wrap the instruments after sterilization since, in addition to being useless
and completely senseless, is also potentially damaging;
2. Store the material in a dry, suitably clean and disinfected place, far from the area where infected
material passes. If possible, use closed compartments equipped with ultraviolet light;
3. Identify the sterile material by attaching the sterilization data (attaching a copy of the printed
report or an adhesive label);
4. First use the material that has been stored the longest (FIFO, "First In First Out"). This results
in material that is homogeneously stored, avoiding storing for too long, with the consequent
risks.
5. Never store material for too long. In fact, do not overlook the fact that materials will tend to degrade
and be recontaminated in a finite time, even when the above instructions are followed.

NOTE
CoNSULT ThE SpECIFICATIoNS pRovIDED bY ThE MANUFACTURER oF ThE pACkAGING MATERIAL
RELATIvE To ThE MAxIMUM ALLowED SToRAGE TIME.

37
TEST PROGRAMS 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
Introduction
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).

cycle Helix 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
Test/B&D (ONLY
the UNIVERSAL cycles.
FOR B VERSIONS) 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.

11/04/13 10:54

OK

Vacuum Test

Helix Test/B&D

Vacuum + B/D
OK

Helix Test/ B&D

49’ 2.12 Bar


00:00

38
The test device (in accordance with EN 867-5 specifications) consists of a 1.5m-long PTFE tube
with an inside diameter of 2mm to whose end a small hermetically-sealed screw cap is fastened,
able to contain an appropriate chemical indicator. The other end of the tube is left free so that the
steam can penetrate and you can assess its effectiveness.

To conduct the test (with reference to EN 13060), insert the chemical indicator (consisting of a
paper strip with a special reagent ink) in the device cap (always to be used perfectly dry). Tighten
the cap in such a way that seepage through the gasket is not possible.

NOTE
The test device and the chemical indicators to execute the
Helix/BD Test cycle are not provided with the sterilizer. For
information in this regard, contact Customer Service (see Ap-
pendix).
Place the device roughly in the middle of the central tray. Do not insert other material in the cham-
ber. Close the door and start the cycle.

The test cycle takes place with a succession of phases similar to those described for a normal
sterilization cycle.
At the end of the cycle, remove the test device from the chamber, open the cap and remove the
indicator from its housing.
If the steam has correctly penetrated, the ink will have completely changed its original colour
over the entire length of the strip; if not (insufficient penetration), there will only be a partial colour
change or even no change at all.

NOTE
Normally, the colour changes from a light colour (beige,
yellow, etc.) to a dark colour (blue, violet or black). In any
event, strictly follow the instructions and any additional
technical details provided by the indicator manufacturer.

39
cycle VACUUM TEST
The Vacuum Test cycle allows testing perfect seal of the sterilizer hydraulic system.
Measuring the variation of the degree of vacuum in a defined time-frame and comparing it with
pre-established limit values, you can determine how good the seal of the sterilization chamber,
tubes and the various interception devices is.

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

11/04/13 10:54

OK

Vacuum Test
Helix Test/B&D
OK

Vacuum Test

15’ -0.80 bar


00:00

Vacuum Test 40°C

Vacuum -0.78 bar

08:00 0’

40
The Vacuum Test program is run with the sterilization chamber empty, and only the trays and
their supports.
NOTE
RUN THE VACUUM TEST AS THE FIRST CYCLE AFTER POWERING-ON THE
EQUIPMENT.

A high chamber temperature affects the variation in the vacuum value measured during the test;
the system is therefore programmed to prevent execution of the test when the operating condi-
tions are inadequate.
Close the door and start the program.
The vacuum phase starts immediately and the pressure value (bar) and the countdown from the
start of the test cycle is shown on the display.
NOTE
If the pressure variation exceeds the limit defined, the pro-
gram is interrupted and an alarm message generated. For a
complete description of the alarms, refer to the Appendix.

VACUUM TEST + Selecting this option, you can run a VACUUM TEST cycle and a Helix Test/B&D cycle in
sequence.
Helix Test/B&D
cycle (ONLY FOR
B VERSIONS) Helix Test/B&D

Vacuum + B/D
H2O Test
OK

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.
NOTE
The presence of the Helix Test device does not alter execu-
tion and the result of the Vacuum Test cycle.

H2O TEST (ONLY Selecting this option, you can test the water quality .
FOR B VERSIONS)
Vacuum + B/D

H2O Test

OK

H2O Test

15 µS
Excellent Normal Substandard

NOTE
THE WATER CONDUCTIVITY IS AUTOMATICALLY MEASURED AT EACH
STERILIZATION OR TEST CYCLE START.

41
DOOR OPENING To open the autoclave door, hold down the button shown in the figure.

11/04/13 10:54

OK

The door opens and stays ajar.

You can now manually open the door.

42
USED WATER DRAIN 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 end
of the drain tube provided in the basin.
2. Insert the other end of the tube in the female union beneath the chamber inlet (connector on the
right) pushing down until you hear a click.
3. Completely empty out the tank and then press on the metal lever of the union and detach the tube
quick-coupling.

Detaching the pipe

WARNING
DO NOT OPEN THE TANK DOORS DURING CYCLE EXECUTION IN ORDER TO
PREVENT HOT WATER LEAKS OR SPURTS.

43
MANUAL The cycle can be interrupted manually by the operator at any time by holding down the button
INTERRUPTION shown in the figure for three seconds.

134°C Univ. 134°C

Warming up 2.12 Bar

39:00 4’

>3 s

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

NOTE
If the cycle is interrupted during certain phases, an auto-
matic cleaning procedure of the internal hydraulic circuit
starts.
For a complete description of the alarms, refer to the Ap-
pendix "Alarm Indications".

WARNING
After manually interrupting a program, DO NOT USE THE LOAD,
AS STERILIZATION IS NOT GUARANTEED.

44
DATA MANAGEMENT To access the DATA MANAGEMENT section, select the following icon and press the OK button.

11/04/13 10:54

OK

PRINT MANAGEMENT

To set the parameters, select the following option and confirm with OK.
Gestione stampe
Gestione USB
Informazioni di sistema
Print management OK

USB management
OK

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

Paper setting
Print last cycle
OK

Labels
Report
OK

45
134°C Univ. 60°C

Completed 1.12 Bar

00:00 0’

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.

Print labels

No. of labels 20
Expiry (days) 10

Print labels

No. of labels 20
Expiry (days) 10

OK

Print labels

No. of labels 20
Expiry (days) 10

OK

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.

Paper setting
Print last cycle
Print technical report
OK

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).

46
USB MANAGEMENT

Before carrying out the following operations, insert the USB key.Print management
USB management
Selecting USB MANAGEMENT, you can choose whether to download the data or the technical
System information
report. Print management OK
USB management
Print management
System information
USB management
OK
Print management
System information
USB management Print management OK

System information
Print management USB management
OK
USB management System information
OK
System information
Selecting CYCLE DATA DOWNLOAD, OK
you can copy the data relating to the cycles executed (sto-
red in the internal memory of the sterilizer) to the USB key.
Downl. cycle data
Download technical report
OK
Downl. cycle data
Download technical report
Downl. cycle data
OK
Download technical report
Downl. cycle data OK

Download technical report Downl. cycle data New


OK
Downl. cycle data Download technical report Last 10
NOTE OK
Download technical report All
The USB key must be formattedOK using
New the FAT32 file system. OK
Last 10
You can select the number of cycles to download
New to the external memory.
All
Last 10
OK
New
All
Last 10 New OK

All
New Last 10
OK
Last 10 All
OK
All
OK

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

Insert key

Insert key

Insert key

Insert key Download in progress...

Download in progress...

Download in progress...

Download in progress...

Download in progress...

Download in progress... Download completed


Remove key

Download completed
Remove key
Download completed
Remove key

Download completed
Once the data has beenkeydownloaded,
Remove you can remove the USB key.
Download completed
Remove key
Download completed
Remove key
WARNING

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

47
SYSTEM INFORMATION

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

USB management
System information

OK

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

48
APPendix – Technical Characteristics
SUMMARY TABLE

Device B Classic-28
Classification (according to
the Directive 93/42/EEC and Steam Sterilizer
subsequent changes)

Model II b

CeFla s.c.
Manufacturer Via Selice prov.le 23/a
40026 Imola (bo) Italy

Power supply voltage 120 V~ 60 hz

Mains fuses
F 15A 250V
(6.3 x 32 mm)
On-board fuses F1: T3.15A 250V (primary transformer)
(5 x 20 mm) F2: T 3.15A 250V (vacuum pump)

Nominal power 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)

Temperature: +15°C ÷ +35°C


Environmental operating conditions Relative humidity: max 80%, non-condensing
Altitude: max 3000 m (a.s.l.)
External dimensions (WxHxD)
480 x 500 x 600 mm
(excluding rear connections)

Net weight:
about. 58 kg
empty
empty with trays and supporti about. 60 kg
empty, with trays and supports and
water at MAX level about. 64 kg

Sterilization chamber dimensions


280 x 450 mm
(Ø x D)
about. 28 l
Sterilization chamber total volume
(0.028 m3)
Sterilization chamber useful volume about. 19 l
(with tray supports inserted) (0.019 m3)
Distilled water tank capacity about 5,5 l (water at max level)
(supply) about 1 l (water at MIN level)
Sterilization programs 4 standard programs + 1 user-defined program
Helix/BD Test (only for B versions)
Test programs Vacuum Test
Vacuum Test+Helix/BD Test (only for B versions)
Preheating time
about 10 min
(from cold)
USB connection requires memories formatted with the FAT32 file system

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

Bacteriological filter Porosity: 0,2 mm


(PTFE filtering element) Connection: male 1/8” NPT connector

49
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.

50
Water supply characteristics

VALUES IN
DESCRIPTION WATER SUPPLY VALUES
CONDENSATE
DRY RESIDUE < 10 mg/l < 1 mg/l

SILICON OXIDE SiO2 < 1 mg/l < 0.1 mg/l

IRON < 0.2 mg/l < 0.1 mg/l

CADMIUM < 0.005 mg/l < 0.005 mg/l

LEAD < 0.05 mg/l < 0.05 mg/l


HEAVY METAL RESIDUES
< 0.1 mg/l < 0.1 mg/l
(except iron, cadmium and lead)
CHLORINES < 2 mg/l < 0.1 mg/l

PHOSPHATES < 0.5 mg/l < 0.1 mg/l

CONDUCTIVITY AT 20 °C < 15 ms/cm < 3 ms/cm

pH VALUE 5-7 5-7


colorless, transparent, colorless, transparent,
APPEARANCE
without sediments without sediments
HARDNESS < 0.02 mmol/l < 0.02 mmol/l

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

WARNING
THE USE OF WATER FOR GENERATING STEAM CONTAINING CONTAMINANTS IN
LEVELS EXCEEDING THOSE SHOWN IN THE TABLE WILL SIGNIFICANTLY SHORTEN THE
STERILIZER’S LIFE.
IN ADDITION, THIS MAY INCREASE THE OXIDATION OF MORE SENSITIVE MATERIALS AND
INCREASE LIME RESIDUES ON THE GENERATOR, BOILER, INTERNAL SUPPORTS AND
INSTRUMENTS.

51
APPENDIX – PROGRAMS

INTRODUCTION
The steam sterilizer is appropriate for almost all materials and instruments, so long as they are able to tolerate, without damage,
a minimum temperature of 121 °C (otherwise, you will need to use other low-temperature sterilization systems).

The following material can normally be sterilized with steam:

– Stainless steel surgical/generic instruments;


– Carbon steel surgical/generic instruments;
– Rotating and/or vibrating instruments driven by compressed air (turbines) or mechanical transmission (counter-angles, tooth
scalers);
– Mineral-based articles;
– Articles made of heat-resistant plastic;
– Heat-resistant textiles;
– Medication materials (gauze, pads, etc.);
– Other generic material suitable for autoclave treatment.

NOTE
DEPENDING ON THE CONFORMATION OF THE MATERIAL (SOLID, HOLLOW OR POROUS),
ANY PACKAGING (PAPER/PLASTIC ENVELOPE, STERILIZATION PAPER, CONTAINER,
MUSLIN NAPKIN, ETC.) AND ITS HEAT-RESISTANCE, IT IS INDISPENSABLE THAT YOU
CHOOSE THE APPROPRIATE PROGRAM BY REFERRING TO THE TABLE SHOWN ON THE
NEXT PAGE.

WARNING
THE DEVICE MAY NOT BE USED FOR STERILIZATION OF FLUIDS, LIQUIDS OR
PHARMACEUTICAL PRODUCTS.

52
PROGRAM SUMMARy TABLE

B Classic-28 model    120 V~ 60 hz 

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

AVERAGE ENERGY
(AVERAGE LOAD ÷
PROGRAM NAME

MAXIMUM LOAD
DRYING TIME (*)
TEMPERATURE
STERILIZATION

CONSUMPTION

CONSUMPTION
AVERAGE H2O

(KWH /CYCLE)
TOTAL CYCLE
CYCLE TYPE

(ML /CYCLE)
MAX LOAD)
AND TIME

(**) (***)
TIME
5 kg unwrapped metal or polymer instruments and
dental handpieces (max 0.9 kg per tray)
2.5kg single package metal or polymer instruments
(C1) PREVACUUM 134°C / 273°F and dental handpieces (max 0.9 kg per tray)
UNIVERSAL (3 steps; -0.8 14.5 min 58÷61 859 0,8 1.5kg double package metal or polymer instruments
134 bar each step) 4 minutes 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

5 kg unwrapped metal or polymer instruments and


dental handpieces (max 0.9kg per tray)
2.5kg single package metal or polymer instruments
(C2) PREVACUUM 121°C / 250°F and dental handpieces (max 0.9kg per tray)
UNIVERSAL (3 steps; -0.8 14.5 min 70÷73 890 0,9 1.5kg double package metal or polymer instruments
121 bar each step) 20 minutes 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

5 kg unwrapped metal or polymer instruments


PREVACUUM 134°C / 273°F
(C4) SOLID (max 0.9kg per tray)
(1 step; -0.8 14.5 min 43÷46 477 0,7
134 2.5kg single package metal or polymer instruments
bar) 4 minutes
(max 0.9kg per tray)

(C5) PREVACUUM 134°C / 273°F


5 kg unwrapped metal or polymer instruments
HOLLOW (3 steps; -0.8 3 min 47÷50 890 0,8
(max 0.9kg per tray)
134 bar each step) 4 minutes

PREVACUUM 134°C / 273°F


HELIX/BD
(3 steps; -0.8 1.5 min 44 / / Test device only (without another load)
TEST
bar each step) 3.5 minutes
Empty chamber
VACUUM Vacuum
/ / 20 / / Vacuum -0.8 bar
TEST (-0.8 bar)
Test Time: 27 min
VACUUM +
HELIX/BD / / / 66 / / /
TEST (****)

(*) 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)
STERILIZATION PROGRAM DIAGRAM

Pressure (bar)
PROGRAM
134°C - UNIVERSAL
PROCESS
134°C - 4' 00''
2.10
2.00

1.00

Time (min)
0.00

-0.80

PRE-VACUUM LONG DRYING

Pressure (bar)
PROGRAM
121°C - UNIVERSAL
121°C - 20'00''

PROCESS
1.10
1.00

Time (min)
0.00

-0.80

LONG DRYING
FRACTIONATED PRE-VACUUM

61
Pressure (bar) PROGRAM
134°C - HOLLOW
PROCESS 134°C - 4'00''
2.10
2.00

1.00

Time (min)
0.00

-0.80

-1.00
FRACTIONATED PRE-VACUUM SHORT DRYING

Pressure (bar)
PROGRAM
PROCESS 134°C - WRAPPED
134°C - 4'00''
2.10
2.00

1.00

Time (min)
0.00

-1.00
ONE SHOT PRE-VACUUM LONG DRYING

62
DIAGRAMS of THE TEST PROGRAMMES

Pressure (bar) PROGRAM


BOWIE & DICK TEST
PROCESS 134°C - 3'00''

2.10 (ONLY FOR B VERSIONS)


2.00

1.00

Time (min)
0.00

0.00
- 1.00 SHORT DRYING
FRACTIONATED PRE-VACUUM

Pressure (bar) PROGRAM


VACUUM TEST (VT)
-0.80 bar

1.00

Intermediate condition for End condition for


the continuation of the test positive test result

0.00 t1 (P2-P1) < (P0-P1) /10 t2 = t1+300 s (P3-P2) < 0.013


0.02 bar t3 = t2+600 s Time (min)

P 0
5 minutes 10
16 minutes
minutes
VACUUM
PHASE

WAITING LEAKAGE

-0.80 P2 P3
P1

63
EXAMPLES OF PRINTED REPORTS
(WITH OPTIONAL PRINTER)

64
APPENDIX – MAINTENANCE
In addition to correct use, the user needs to perform ordinary maintenance in order to guarantee safe, efficient operation over the
device’s entire life.

For better quality maintenance, supplement ordinary checks with regular periodic examinations
Introduction by the service department (see Appendix).

It is also fundamental to perform a periodic sterilizer validation, i.e., a check of the


thermodynamic parameters of the process, comparing them with the reference values provided
with suitably calibrated instruments. In this regard, see the paragraph, “Periodic Sterilizer’s
Validation”, further below in this Appendix.

The ordinary maintenance described below consists in easy manual operations and preventive
interventions involving simple instruments.

WARNING
In the event of the replacement of the device’s components
or parts, request and/or use ORIGINAL REPLACEMENT PARTS
ONLY.
Ordinary The table summarizes the maintenance required to keep the sterilizer operating at peak
Maintenance efficiency. In the case of very intense use, we recommend shortening maintenance intervals:
Program
Clean the gasket on the porthole
DAILY
Clean external surfaces

Clean the sterilization chamber and relative accessories


WEEKLY
Disinfect external surfaces

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


tank
MONTHLY
Safety valve maintenance
Clean (or replace) the drain filter

ANNUALLY Validate sterilizer (see dedicated paragraph)

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

Message

Clean the dust filter


Replace the bacteriological filter

OK

Press the OK button to confirm that the required maintenance operation has been completed.

Press the button to postpone the operation.


In this case, the warning message will reappear the next time the sterilizer is used..

65
WARNING MESSAGE
BOILER FILTER CLEANING
DOOR LOCK LUBRICATION
duST FIlTeR CleanInG

BACTERIOLOGICAL FILTER
REPLACEMENT
WATER TANK CLEANING
BOILER GASKET REPLACEMENT
GENERAL SERVICE
NOTE
TO 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.

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

66
DANGER
BEFORE PERFORMING ORDINARY MAINTENANCE, MAKE SURE THAT THE
POWER SUPPLY CORD IS REMOVED FROM THE MAINS SOCKET.

WHENEVER IT IS NOT POSSIBLE, PUT IN OFF THE EXTERNAL BREAKER


OF THE EQUIPMENT POWER SUPPLY LINE.

IF THE EXTERNAL BREAKER IS FAR AWAY OR, AT ANY RATE, NOT VISIBLE
TO THE MAINTAINER, PLACE A WORK IN PROGRESS SIGN ON THE
EXTERNAL BREAKER AFTER TURNING IT OFF.

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


Description

Clean gasket and porthole


To eliminate any traces of limestone, clean the chamber gasket and the door window with a
clean cotton cloth that has been soaked in a weak solution of water and vinegar (or a similar
product; verify the contents on the label before using).

Dry the surfaces and remove any residues before using the device.

Clean external surfaces Clean all the external parts using a clean cotton cloth dampened with water and, possibly,
the addition of a neutral detergent.
Dry the surfaces and remove any residue before using the device.

Clean sterilization chamber Clean the sterilization chamber, support and trays (and internal surfaces in general) with a
and accessories clean cotton cloth soaked in water and, possibly, the addition of a small amount of neutral
detergent.
Carefully rinse with distilled water, taking care not to leave any type of residue in the chamber
or on accessories.

NOTE
Do not use pointed or sharp tools to remove scale from the
sterilization chamber. Should there be evident deposits, im-
mediately check the quality of the distilled water used (see
Appendix Technical Features).

Disinfect external surfaces For the occasional disinfection of the external surfaces, you can use either denatured alcohol
or detergents with a minimum percentage of sodium hypochlorite (or equivalent).

67
Boiler filter cleaning With use it is likely that various residues accumulate in the filter and with time obstruct the lower
drain duct.
To clean the filter, open the sterilizer door and remove the cap using a coin or another suitable
tool.
Then unscrew the union containing the filter.
Remove the filter from its holder and thoroughly clean it under a jet of running water, if necessary
using a sharp tool to remove any large foreign bodies (if possible use a jet of compressed air).
If it is impossible to recover the filter, replace it with a new one.
Refit everything operating in reverse order from removal and making sure that you screw the
union on in such a way that the drain holes are positioned at the level of the boiler wall.

NOTE
Properly fit the filter in its housing; fitting it only partially
may damage the component.

Using a clean cloth, remove any residues from the bushing and the screw.
Door lock lubrication
Lubricate the inside of the bushing on the sterilizer door with a film of the silicon-based grease
provided (as shown in the figure).

NOTE
PUT 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.

68
Dust filter cleaning (ONLY Remove the dust filter (A) from the lower part of the autoclave, thoroughly rinse it with water and
FOR B VERSIONS) dry it before refitting it.

Replace the bacteriological When filter maintenance is due according to the maintenance schedule or every time you notice
filter visible clogging of the filter (indicated by the filter markedly turning grey), unscrew the bacterio-
logical filter (B) from its holder and replace it with a new one, screwing it fully down on the union.

NOTE
A spare bacteriological filter is provided with the sterilizer.
To order further filters, refer to the Appendix TECHNICAL
SERVICE.

Water tank cleaning 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.

C C

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

NOTE
DO NOT USE CLEANING PRODUCTS INSIDE THE TANK. USE A DRY CLOTH
ONLY.

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

69
Periodic sterilizer As happens with all equipment, it is possible, and sometimes inevitable, to have a decrease in
validation performance and the effectiveness of components along its lifespan, in a period of time dependent
on its frequency of use.
To guarantee the safety of the process over time, it is periodically (possibly annually) necessary
to verify the thermodynamic process parameters (pressure and temperature), to check if they
continue to remain within allowed limits or not.
The requalification of the sterilizer’s performance is the responsibility of the user of the product.
The reference European standards EN 17665 (Sterilization of the medical devices - Method for
the validation and systematic control of the steam sterilization) and EN 556 (Sterilization of the
medical devices – Requirements for the medical devices marked with “STERILE” indication)
supply an effective guide tool for carrying out the verifications on the steam sterilizers.

Since, in addition to specific experience and training, these controls require the use of special
equipment (high-precision sensors and probes, data loggers, dedicated software, etc.) suitably
verified and calibrated, it is necessary to contact a company specializing in these activities.

Customer support department (see Appendix is available to provide any information relative to
the periodic validation of steam sterilizers.

DISPOSAL at In accordance with Directives 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
end-of-life
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.

70
APPENDIX – GENERAL PROBLEMS
Introduction

If you run into a problem or alarm while using the device, you should not be immediately concerned.
It may not, in fact, be related to a breakdown but, more probably to an anomalous situation, often merely transitory (such as a
blackout), or incorrect use.

In any case, it is important to first identify the cause of the anomaly and then take suitable corrective action, either autonomously or
with the help of the Technical Support Department (see Appendix Z).

For this purpose, below, we provide instructions for diagnosing and resolving general problems, in addition to a precise description of
the alarm codes, their meaning and their solution.

Analysis and resolution of problems


If your sterilizer is not working correctly, please make the following checks before calling the Technical Support Department:

PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION

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

Check the cause of the lack of voltage at and


There is no voltage at the socket.
socket and fix it.

The sterilizer does not power-on. The main switch and/or differential
Turn the switch ON.
switch are OFF.
Replace with good fuses of equal nominal
value.
The mains fuses are blown.
(See the Summary Table in Appendix
Technical Characteristics).

Wait for the sterilizer to reach the proper


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

Check that the knurled locking ring is cor-


rectly tightened on the upper part of safety
valve.

DANGER
Locking ring loosened.
LET THE DEVICE
The safety valve has intervened. Presence of anomalous overpressure in COOL, OR WEAR
the chamber. GLOVES TO AVOID
BEING BURNED
WHEN TOUCHING
THE VALVE.

.
Check the seal of the unions; if necessary,
refit paying greater attention.
Automatic water filling system tube (op-
tional) not properly connected. Check that the tubes are completely fitted on
the unions; check that the hose clamps are
There is water on the support surface of fitted.
the sterilizer.
At the end of the cycle, clean the gasket and
porthole of the container under pressure.
Steam leaks from the gasket.
Check if the gasket is damaged.
Run another cycle and check the situation.

71
PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION
Check the quantity of material sterilized
and make sure that it does not exceed
Excessive quantity of material inside the the maximum allowed quantity,
sterilization chamber. depending on the type of load.
(See the Summary Table in Appendix
Technical Characteristics”).
Position the material, and especially
wrapped material, according to the
Material not correctly positioned. instructions.
Excessive humidity on the material (See the Chapter, “Preparing the
and/or instruments at the end of the Material”).
program.
Select the appropriate sterilization
program for the type of material to be
Wrong sterilization program selection treated.
(See the Summary Table in Appendix
“Programs”).

Drain filter of the sterilization chamber Clean or replace the drain filter
obstructed. (See Appendix “Maintenance”).

Check the quality of the instruments


Quality of the instruments is not with the problem, checking whether the
adequate. material they are made of can tolerate
steam sterilization.

Empty the tank and fill it with high-


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

Check the adequacy of the sterilization


temperature of the selected program in
Blackening of the instruments or relation to the material to be treated.
Wrong sterilization program selection.
damage to the material.
(See the Summary Table in Appendix
“Programs”).

72
APPENDIX – alarms

NOTE
If the problem persists, contact Technical Service (see Appendix)
communicating the sterilizer model and serial number.
This data is indicated on the registration plate on the rear of
the device and on the declaration of conformity

Introduction Every time an anomalous condition occurs during the operation of the sterilizer, an alarm is
generated, identified by a specific code (consisting of a letter followed by a 3-digit number).
Alarm codes are divided into three categories:

• E = ERROR/WARNING
Incorrect handling and/or use or a cause outside the device.
The problem can normally be solved by the user.
Code format: Exxx (xxx = identification number 000 - 999)

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

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

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

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

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

Alarm during a cycle The alarm procedure has been devised so that the user cannot confuse an abnormal cycle with a
correctly completed cycle and hence involuntarily use non-sterile material ; it is structured to
guide the user up to sterilizer RESET and subsequent use.

73
System reset
The system can be reset in two alternative ways depending on the type of alarm that has occurred (see the list of alarm
codes further on in this appendix):

1. Pressing the OK button

2. Following the on-screen instructions and holding down the RESET button for about 3 seconds.

Warning

Error E030
Min water level

Pressing the “padlock” button for 3 seconds,


the sterilizer door opens

Warning

Error E030
Min water level
RESET

Pressing the RESET button for about 3 seconds, you go back to the initial menu.

After the RESET and any technical operation necessary to eliminate the fault, the device will be ready to execute a new program.

WARNING

Never turn off the device before having done the Reset.

74
Alarm Codes
The list of alarm codes and, consequently, the messages displayed on the LCD and relative RESET mode, is as follows:

CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE

ERRORS (category E)

E000 Blackout BLACKOUT 2


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

E261 Chamber levelling too slow LEVELLING SLOW 1


Vacuum test failed
E900
(during TEST PHASE)
TEST FAILED 2
Vacuum test failed
E901
(during STANDBY PHASE)
TEST FAILED 2
Vacuum test failed
E902
( vacuum pulse timeout exceeded)
TEST FAILED 2
E999 Manually interrupting the cycle MANUAL INTERRUPTION 2

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

75
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
Temperature sensor PT1 failed
A101
(sterilization chamber)
PTx INTERRUPTED 1
Temperature sensor PT2 failed
A102
(steam generator)
PTx INTERRUPTED 1
Temperature sensor PT3 failed
A103
(heating element)
PTx INTERRUPTED 1
Temperature sensor PT5 failed
A105
(conductivity measurement compensation)
PTx INTERRUPTED 1
Temperature sensor PT1 short-circuited
A111
(sterilization chamber)
PTx SHORT-CIRCUITED 1
Temperature sensor PT2 short-circuited
A112
(steam generator)
PTx SHORT-CIRCUITED 1
Temperature sensor PT3 short-circuited
A113
(heating element)
PTx SHORT-CIRCUITED 1
Temperature sensor PT5 short-circuited
A115
(conductivity measurement compensation)
PTx SHORT-CIRCUITED 1

A116 ADC error ADC error 1


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

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


Pre-heating slow (tube bundle heating ele- HEATING ELEMENT WARM-UP
A204
ment) SLOW 2

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

76
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE

ALARMS (category A)
1st vacuum pulse not reached within the ti-
A250
meout
PV1 TIMEOUT 2
1st rise back up to atmospheric pressure not
A251
reached within the timeout
ATM1 TIMEOUT 2
1st pressure pulse not reached within the ti-
A252
meout
PP1 TIMEOUT 2
2nd vacuum pulse not reached within the ti-
A253
meout
PV2 TIMEOUT 2
2nd rise back up to atmospheric pressure not
A254
reached within the timeout
ATM2 TIMEOUT 2
2nd pressure pulse not reached within the
A255
timeout
PP2 TIMEOUT 2
3rd vacuum pulse not reached within the ti-
A256
meout
PV3 TIMEOUT 2
3rd rise back up to atmospheric pressure not
A257
reached within the timeout
ATM3 TIMEOUT 2
3rd pressure pulse not reached within the ti-
A258
meout
PPP TIMEOUT 2
Chamber depressurization not completed
A260
within the timeout
PPD TIMEOUT 2
Chamber levelling not completed within the
A261
timeout
LEVELLING TIMEOUT 2
1st drop to atmospheric pressure not comple-
A353
ted within the timeout
DRAIN TIMEOUT 2
2nd drop to atmospheric pressure not comple-
A356
ted within the timeout
DRAIN TIMEOUT 2
Vacuum pulsation during drying not executed
A360
within timeout
TIME OUT PPD 2

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

77
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
Pconv/T ratio not balanced (Pconv>T)
H400
( PROCESS phase)
Incorrect P/T ratio 2
T/Pconv ratio not balanced (T>Pconv)
H401
( PROCESS phase)
Incorrect P/T ratio 2
Temperature above the MAXIMUM limit
H402
( PROCESS phase)
T above MAX limit 2
Temperature below the MINIMUM limit
H403
( PROCESS phase)
T below MIN limit 2
Temperature fluctuating over limit
H404
( PROCESS phase)
T FLUCTUATING OVER LIMIT 2
Pressure above MAX limit
H405
( PROCESS phase)
P above MAX limit 2
Pressure below Min limit
H406
( PROCESS phase)
P BELOW MIN LIMIT 2
Retention time incorrect
H410
(PROCESS phase)
TIMER PROBLEM 2
Excessive pressure
H990
(sterilization chamber, MPX)
EXCESSIVE PRESSURE 2
Overheating
H991
(sterilization chamber, PT1)
PT1 OVERHEATING 2
Overheating
H992
(steam generator, PT2)
PT2 OVERHEATING 2
Overheating
H993
(tube bundle heating element, PT3)
PT3 OVERHEATING 2

CODE ALARM DESCRIPTION LCD INDICATION RESET MODE

SYSTEM ERRORS (category S)

S001 Flash Memory 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
Printer: there is no paper or there might be a
S010
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

78
Analysis and resolution of problems
Based on the type of alarm, below we provide instructions for identifying the possible causes and restoring correct operation:

ERRORS (category E)

CODE POSSIBLE CAUSE SUGGESTED SOLUTION


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

The main switch has accidentally been turned off Reconnect the plug and/or turn the device on again and do a
and/or the power plug pulled from the socket. RESET following the instructions.
E 000

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

Do a reset following the instructions. If the problem occurs


E001 Abnormal voltage peak on the mains
again, have the mains electric system checked by a technician.

Do a RESET following the instructions. Empty the feed tank and


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

Do a RESET following the instructions. IMMEDIATELY empty


the feed tank and refill it with distilled water of adequate quality
(<15µs/cm). If an automatic filling system is present, IMME-
DIATELY empty the external container and fill it with water of
adequate quality. If a demineralizer (Pure100/500) is present,
E003 The feed tank contains water of very poor quality. IMMEDIATELY replace the filter elements.
NOTE: In these conditions, the sterilizer allows starting a MAXI-
MUM OF 5 CONSECUTIVE CYCLES, after which it locks until
the tank is filled with distilled water of adequate quality (<15µs/
cm). This precaution is necessary to prevent possible damage
to the device.

Door open (or not properly closed) at program start Do a RESET following the instructions.
(START). Properly close the doorand restart the program.
E010
Contact Technical Service
Door position microswitch failure.
(see Appendix).

Do a RESET following the instructions.


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

Do a RESET following the instructions.


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

Do a RESET following the instructions.


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

Contact Technical Service


MIN water level sensor failure.
(see Appendix).

79
CODE POSSIBLE CAUSE PROPOSED SOLUTION

Do a RESET following the instructions and empty the tank.


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

Contact Technical Service


MAX water level sensor failure.
(see Appendix).

Do a RESET following the instructions.


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

E040 Do a Reset following the instructions.


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

Contact Technical Service


Automatic filling system failure.
(see Appendix).

Do a RESET following the instructions.


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

Automatic filling system failure.


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

Clean the drain filter (see the Appendix "MAINTENAN-


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

Clean the drain filter (see the Appendix "MAINTENAN-


Bacteriological filter obstructed.
CE").
E261
Problem in the hydraulic circuit Contact Technical Service (see Appendix).

Do a Reset following the instructions.


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

Do a RESET following the instructions.


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

Do a RESET following the instructions.


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

Contact Technical Service


Problem in the hydraulic circuit.
(see Appendix).

80
CODE POSSIBLE CAUSE SUGGESTED SOLUTION

Do a RESET following the instructions.


Excessive humidity in the sterilization chamber. Thoroughly dry the inside of the chamber and restart the pro-
gram.
Do a RESET following the instructions.
Thoroughly clean the gasket with a clean cotton cloth moiste-
E902 Air seepage through the gasket
ned with water.
Restart the program.

Vacuum pump failure.


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

Manual interruption of the sterilization or test


E 999 Do a RESET following the instructions.
cycle.

ALARMS (category A)

A 022 Door lock mechanism limit microswitch failure.


Contact Technical Service
Water level sensor connector not connected. (see Appendix).
A 032
Water level sensor failure.

A 101 Chamber temperature sensor failure (PT1).

A 102 Steam generator temperature sensor failure (PT2).

A 103 Heating element temperature sensor failure (PT3).

Temperature sensor PT5 failed


A 105
(conductivity measurement compensation)

Incorrect temperature sensor connection (sterilization chamber).


A 111 Contact Technical Service
Temperature sensor short-circuit (sterilization chamber). (see Appendix).

Incorrect temperature sensor connection (steam generator).


A 112
Temperature sensor short-circuit
(steam generator).

Incorrect temperature sensor connection (heating element).


A 113
Temperature sensor short-circuit (heating element).
Temperature sensor PT5 short-circuited
A115
(conductivity measurement compensation)

A116 ADC error

A120 Reference heating element acquisition chain fault


Contact Technical Service
(see Appendix).
A121 Reference heating element acquisition chain fault

A122 Reference heating element acquisition chain fault

81
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
Reference heating element acquisition
A123
chain fault

Reference heating element acquisition


A125
chain fault

Steam generator safety thermostat inter-


vened.
A 201
Steam generator or heating element mal-
function.

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

A 203 Steam generator malfunction

A 204 Heating element malfunction

Do a RESET following the instructions.


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

A 250 Do a RESET following the instructions.


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

Vacuum pump failure.


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

Water injection pump malfunction.

Problem in the hydraulic circuit.

Contact Technical Service


A 251 Steam generator safety thermostat inter- (see Appendix).
vened.

Steam generator malfunction

82
CODE POSSIBLE CAUSE SUGGESTED SOLUTION

Do a RESET following the instructions.


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

Do a RESET following the instructions.


Excessive load. Check that the load does not exceed the maximum values permitted.
A 252 (see Summary Table in the Appendix Technical Features).

Problem in the hydraulic circuit.

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


intervened.

Steam generator malfunction

Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE”)
A 353
Problem in the hydraulic circuit Contact Technical Service (see Appendix).

Do a RESET following the instructions.


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

Do a RESET following the instructions.


A 253
Air seepage through the gasket. 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.

Water injection pump malfunction.

Problem in the hydraulic circuit.

Contact Technical Service


A 254 Steam generator safety thermostat
(see Appendix).
intervened.

Steam generator malfunction

83
CODE POSSIBLE CAUSE SUGGESTED SOLUTION

Do a RESET following the instructions.


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

Do a RESET following the instructions.


Excessive load. Check that the load does not exceed the maximum values permitted.
(see Summary Table in theAppendix Technical Features).
A 255

Problem in the hydraulic circuit.

Steam generator safety thermostat Contact Technical Service


intervened. (see Appendix).

Steam generator malfunction

Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 356
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).

Do a RESET following the instructions.


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

Do a RESET following the instructions.


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

Vacuum pump failure.


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

Water injection pump malfunction.

Problem in the hydraulic circuit.


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

Steam generator malfunction

Do a RESET following the instructions.


Steam seepage through the gasket. Thoroughly clean the gasket with a clean cotton cloth moistened with water
and restart the program.
A 258 Do a RESET following the instructions.
Excessive load. 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).

84
CODE POSSIBLE CAUSE SUGGESTED SOLUTION

Steam generator safety thermostat


intervened.
Contact Technical Service
A 258
(see Appendix).
Steam generator malfunction.

Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 260
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).

Bacteriological filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 261
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).

Drain filter obstructed. Clean the drain filter (see Appendix: “Maintenance").
A 360
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).

85
HAZARDS (category H)

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

H 150 Pressure sensor (MPX) failure.

Pressure sensor (MPX) not properly


connected to the connector.
H 160
Pressure sensor (MPX) short-circuit.

H 400 Problem in the hydraulic circuit.


H 401 Problem in the hydraulic circuit.

Steam generator malfunction.


H 402
Problem in the hydraulic circuit.

Steam generator malfunction.


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

Problem in the hydraulic circuit.


H 405
Steam generator malfunction.

Problem in the hydraulic circuit.


H 406
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.

86
SYSTEM ERRORS (category S)

CODE POSSIBLE CAUSE SUGGESTED SOLUTION

S001 Flash Memory Failure

S002 Flash Full

S005 USB Key Failure

S006 USB Stick not accessible


Contact Technical Service
S007 USB stick full
(see Appendix).
S009 NO PRINTER

S010 PRINTER: NO PAPER

S011 PRINTER: DOOR OPEN

S012 PRINTER NOT READY

87
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

88
APPENDIX – LABELING

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

- manufacturer name and address

-manufacturer model
-reference number

-serial number

-power information

-pressure

-chamber volume

(note: this is the back of the autoclave) -Fuse information

-manufacturing date

- CE Mark symbol

- Read instruction symbols

-European Disposal symbol


Label

Position (refer to the red circle) Label content


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

-Indication for water drain connector


(Connection for “direct water drainage”).

(note: this is the back of the autoclave)


Label

Position (refer to the red circle) Label content


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

(note: this is the back of the autoclave)


Label

Position (refer to the red circle) Label content


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

Note: this is the side of the autoclave


Label

Position (refer to the red circle) Label content


- Caution about hot
surface (laser marked
label)

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

Position (refer to the red circle) Label content


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

-Distilled water top up quick


coupling

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

Position (refer to the red circle) Label content


- Used water drain quick
connector (laser marked
label)

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

Position (refer to the red circle) Label content


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

-Caution about
lubrication of door lock

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

Label

Position (refer to the red circle) Label content


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

Note: this is the water reservoir


APPENDIX – ACCESSORIES

PURE 100 PURE 500

AUTOMATIC FILLING FRONT FILLING

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.

PRINTER H2O AUXILIARY SOLENOID VALVE

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

89
PRINTER Connect the printer to the RS232 serial port located on the rear of the autoclave (see figure).
CONNECTION

Load the desired type of paper and turn on the printer.


Set the type of paper loaded (see the paragraph PRINT MANAGEMENT).

NOTE
REFER TO THE PRINTER MANUAL FOR PRINTER STARTING AND PAPER
LOADING.

90
APPENDIX – TECHNICAL SUPPORT

FOR ANY REQUEST FOR


TECHNICAL SERVICE FOR THE
PRODUCT,
WHETHER IN OR OUT OF
WARRANTY,
DIRECTLY CONTACT THE

TECHNICAL SUPPORT
DEPARTMENT

OF THE DEALER OR RESELLER


THAT SUPPLIED THE PRODUCT.

We will gladly provide any information you may need on the product as well as give you suggestions and advice on the steam
sterilization procedures.

In this regard, please refer to the following address:

www.mocom.it

91

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