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b28 Series PDF
b28 Series PDF
b28 Series PDF
Operating instructions
REVISIONS
The following table lists subsequent editions/revisions of the manual.
The “Description” field brief explains the subject of the latest revision.
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
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
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 – 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 – 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 – ACCESSORIES..............................................................................................................89
PRINTER CONNECTION.............................................................................................................................................. 90
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.
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
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.
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.
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;
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
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
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.
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
Door
On/Off switch
Dust filter
(ONLY FOR B
VERSIONS)
Sterilization chamber
Bacteriological filter
Door
6
REAR
Heat exchanger
Data label
Serial cable connection
Mains fuses
7
LCD ICONS
DATE TIME
11/04/13 10:54
OK
SELECTION
ICONS
DOOR OPENING
11/04/13 10:54
11/04/13 10:54
11/04/13 10:54
11/04/13 10:54
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):
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 R OC E SS
2.10
2.00
1.00
Time (min)
0.00
-0.80
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
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.
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.
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
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
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.
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.
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
Language
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
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
17
USERS
Access the menu by selecting the USERS option and confirm with OK.
Fill in the fields entering the user name and PIN.
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
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
*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
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
User 1
Current PIN
----
OK
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.
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
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
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
User 1
User 2
User 3 OK
User 1
PIN
---- OK
Once the PIN has been confirmed, the cycle automatically starts.
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.
00:00 0’
134°C Univ. 4’
OK
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
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
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
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.
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.
– 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
– 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”.
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
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
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
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
Drying Time
0 min
OK
Drying Time
30 min
OK
134°C Universal B
4’ 134°C
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
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
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
39:00 4’
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
NO OK
134°C Univ. 60°C
00:00 0’
36
MATERIAL STORAGE The sterilized material must be adequately treated and stored to maintain its sterility over time,
until its use.
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
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
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
42
USED WATER DRAIN To activate the automatic tank filling option, refer to the section “Configuration”.
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.
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.
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
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
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
Download in progress...
Download in progress...
Download in progress...
Download in progress...
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
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
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)
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
49
Safety Devices
The sterilizer is equipped with the following safety devices for which we provide a brief description of their function:
–– Safety valve
Protection against overpressure in the sterilization chamber.
Action: release of the steam and restoration of the safety pressure.
50
Water supply characteristics
VALUES IN
DESCRIPTION WATER SUPPLY VALUES
CONDENSATE
DRY RESIDUE < 10 mg/l < 1 mg/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).
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
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
(*) 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
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
1.00
Time (min)
0.00
0.00
- 1.00 SHORT DRYING
FRACTIONATED PRE-VACUUM
1.00
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).
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
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
OK
Press the OK button to confirm that the required maintenance operation has been completed.
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).
–– 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.
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.
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
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.
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).
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”).
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):
2. Following the on-screen instructions and holding down the RESET button for about 3 seconds.
Warning
Error E030
Min water level
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:
ERRORS (category E)
1 = OK (warning)
2 = OK + door unlocking + RESET
75
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET PROCEDURE
ALARMS (category A)
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)
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)
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.
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).
79
CODE POSSIBLE CAUSE PROPOSED SOLUTION
80
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
ALARMS (category A)
81
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
Reference heating element acquisition
A123
chain fault
Heating element safety thermostat inter- Contact Technical Service (see Appendix).
vened.
A 202
Steam generator or heating element mal-
function.
82
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE”)
A 353
Problem in the hydraulic circuit Contact Technical Service (see Appendix).
83
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
Drain filter obstructed. Clean the drain filter (see the Appendix "MAINTENANCE").
A 356
Problem in the hydraulic circuit. Contact Technical Service (see Appendix).
84
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
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)
86
SYSTEM ERRORS (category S)
87
APPENDIX – ADMIN USER PIN RESET
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
-manufacturer model
-reference number
-serial number
-power information
-pressure
-chamber volume
-manufacturing date
- CE Mark symbol
Note: this is the front of the autoclave with the door opened
Label
Note: this is the front of the autoclave with the door opened
Label
Note: this is the front of the autoclave with the door opened
Label
-Caution about
lubrication of door lock
Note: this is the front of the autoclave with the door opened
Label
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.
89
PRINTER Connect the printer to the RS232 serial port located on the rear of the autoclave (see figure).
CONNECTION
NOTE
REFER TO THE PRINTER MANUAL FOR PRINTER STARTING AND PAPER
LOADING.
90
APPENDIX – TECHNICAL SUPPORT
TECHNICAL SUPPORT
DEPARTMENT
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.
www.mocom.it
91