Mocom millenium B2 User manual

Quality System certified by
STEAM
STERILIZER
OPERATING MANUAL
®
Ed. 1
Rev. 5
Date: January 2008
®
®

TABLE OF CONTENTS
I
REVISIONS
The following table lists subsequent editions/revisions of the manual.
The “Description” field brief explains the subject of the latest revision.
Ed. Rev. Date Description
1 0 11-02 First issue
1 1 02-03 A few modifications; added new chapter “Replacing the printer paper”
1 2 03-04 A few small modifications; photo on the cover
1 3 11-04 A few small modifications;
Added the menu option “Password”
1 4 01-06 Upgrade (software, interface with Milldrop and Millflash)
1 5 01-08 EEC standards reference updating
TABLE OF CONTENTS
1 - INTRODUCTION............................................................................................................................1
APPLICABLE EUROPEAN DIRECTIVES........................................................................................................1
INTENDED USE.................................................................................................................................................1
PURPOSE OF THE MANUAL...........................................................................................................................2
GENERAL WARNINGS......................................................................................................................................2
2 - CONTENTS OF THE PACKAGE...................................................................................................3
DIMENSIONS AND WEIGHT............................................................................................................................3
DESCRIPTION OF THE CONTENTS................................................................................................................3
HANDLING THE PRODUCT..............................................................................................................................4
3 - PRODUCT INTRODUCTION..........................................................................................................5
INTRODUCTION................................................................................................................................................5
GENERAL CHARACTERISTICS.........................................................................................................................5
FRONT...............................................................................................................................................................6
REAR .................................................................................................................................................................7
CONTROL PANEL............................................................................................................................................8
LCD DISPLAY....................................................................................................................................................8
OPERATING CYCLE EXAMPLE........................................................................................................................9
4 - INSTALLATION ...........................................................................................................................10
INTRODUCTION..............................................................................................................................................10
COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATIONS................................................................10
GENERAL INSTALLATION PRECAUTIONS..................................................................................................11
ELECTRICAL CONNECTIONS........................................................................................................................11
CONNECTING THE DATA RECORDING MILLFLASH ...................................................................................11
CONNECTING AN EXTERNAL WATER FILLING TANK................................................................................12
CONNECTING DEMINERALIZER MILLDROP...............................................................................................12
CONNECTING AN EXTERNAL DRAIN TANK.................................................................................................13
DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT..................................................................14

TABLE OF CONTENTS
II
5 - FIRST START-UP........................................................................................................................ 15
TURNING ON THE EQUIPMENT.....................................................................................................................15
INITIAL AUTOMATIC TEST.............................................................................................................................15
ACQUISITION AND UPDATING OF THE AMBIENT PRESSURE VALUES....................................................15
STAND-BY MODE............................................................................................................................................16
FILLING DISTILLED WATER ...........................................................................................................................17
Manual filling.............................................................................................................................................17
Automatic filling ........................................................................................................................................17
MAX LEVEL IN THE INTERNAL/EXTERNAL DRAIN TANK............................................................................18
6 - CONFIGURATION....................................................................................................................... 19
INTRODUCTION...............................................................................................................................................19
STARTING AND ENTERING THE SETUP MODE...........................................................................................19
MEANING OF THE KEYS IN SETUP MODE ...................................................................................................19
DESCRIPTION OF THE MENU ITEMS............................................................................................................21
DEFAULTS SETTINGS ....................................................................................................................................23
ACTIVATING CONFIGURATION OPTIONS ...................................................................................................23
Setting the language.................................................................................................................................23
Setting the date ........................................................................................................................................23
Setting the time.........................................................................................................................................24
Setting the password................................................................................................................................24
Setting the sterilization programs .............................................................................................................25
Setting the STAND-BY mode ...................................................................................................................29
Setting the printing mode..........................................................................................................................30
Setting the tank filling mode......................................................................................................................32
Setting the water draining mode..............................................................................................................32
Acquisition of the ambient pressure..........................................................................................................33
Adjusting the contrast of the liquid crystal display ...................................................................................34
EXIT THE CONFIGURATION MODE..............................................................................................................34
7 - PREPARING THE MATERIAL .................................................................................................... 35
INTRODUCTION...............................................................................................................................................35
TREATING THE MATERIAL BEFORE STERILIZATION..................................................................................35
ARRANGING THE LOAD .................................................................................................................................36
8 - PROGRAM SELECTION............................................................................................................. 38
INTRODUCTION...............................................................................................................................................38
PROCEDURE...................................................................................................................................................38
9 - RUNNING THE CYCLE.............................................................................................................. 40
INTRODUCTION...............................................................................................................................................40
STARTING THE CYCLE..................................................................................................................................40
PROGRAM EXECUTION..................................................................................................................................41
RESULT OF THE CYCLE................................................................................................................................45
CHECK OF THE CYCLE DATA REPORT........................................................................................................46
MANUAL CYCLE INTERRUPTION ..................................................................................................................46
10 - STORING STERILIZED MATERIALS ....................................................................................... 48
INTRODUCTION...............................................................................................................................................48
HANDLING .......................................................................................................................................................48
STORAGE ........................................................................................................................................................48
11 - TEST PROGRAMS.................................................................................................................... 49
INTRODUCTION...............................................................................................................................................49
BOWIE & DICK TEST.......................................................................................................................................49
VACUUM TEST ................................................................................................................................................50
APPENDIX A – TECHNICAL CHARACTERISTICS......................................................................... 53
SUMMARY TABLE ...........................................................................................................................................53

TABLE OF CONTENTS
III
SAFETY DEVICES...........................................................................................................................................54
WATER SUPPLY CHARACTERISTICS...........................................................................................................55
APPENDIX B – PROGRAMS............................................................................................................56
INTRODUCTION..............................................................................................................................................56
PROGRAM SUMMARY TABLE .......................................................................................................................57
STERILIZATION PROGRAM DIAGRAM..........................................................................................................59
DIAGRAMS OF THE TEST PROGRAMMES...................................................................................................64
EXAMPLES OF PRINTED REPORTS.............................................................................................................65
APPENDIX C – MAINTENANCE.......................................................................................................67
INTRODUCTION..............................................................................................................................................67
ORDINARY MAINTENANCE PROGRAM........................................................................................................67
MAINTENANCE DESCRIPTION......................................................................................................................68
Clean gasket and porthole.......................................................................................................................68
Clean external surfaces ...........................................................................................................................68
Clean sterilization chamber and accessories...........................................................................................68
Disinfect external surfaces.......................................................................................................................68
Clean internal distilled water tank ............................................................................................................69
Clean external distilled water tank ...........................................................................................................69
Safety valve maintenance........................................................................................................................69
Clean/replace the drain filter....................................................................................................................69
Replace bacteriological filter....................................................................................................................70
Replacing the paper in the printer............................................................................................................70
PERIODIC STERILIZER VALIDATION............................................................................................................71
RECYCLING / DISPOSAL INSTRUCTIONS....................................................................................................71
APPENDIX D – GENERAL PROBLEMS...........................................................................................72
INTRODUCTION..............................................................................................................................................72
ANALYSIS AND RESOLUTION OF PROBLEMS ............................................................................................72
APPENDIX E – ALARMS..................................................................................................................75
INTRODUCTION..............................................................................................................................................75
ALARM INTERVENTION .................................................................................................................................75
Alarm during a cycle.................................................................................................................................75
Alarm outside the cycle...........................................................................................................................76
RESETTING THE SYSTEM............................................................................................................................77
ALARM CODES ...............................................................................................................................................78
ANALYSIS AND RESOLUTION OF PROBLEMS ............................................................................................80
APPENDIX F – DIAGRAMS..............................................................................................................86
ELECTRICAL DIAGRAM (BOARD TYPE “G”).................................................................................................86
ELECTRICAL DIAGRAM (BOARD TYPE “T”)..................................................................................................87
PLUMBING DIAGRAM.....................................................................................................................................88
APPENDIX G – DECLARATION OF CONFORMITY ........................................................................89
APPENDIX H – NOTES PER THE OPERATOR ...............................................................................90
APPENDIX Z – TECHNICAL SUPPORT...........................................................................................91

1. INTRODUCTION
1
INTRODUCTION
Symbols used in the
manual
Dear Customer
Thank you for choosing a product from M.O.COM. Srl. We hope that you will find it completely
satisfactory.
This manual describes all procedures for the correct use of the device and instructions for
deriving 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.
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 TEMPERATURE.
THE MATERIAL THE STERILIZER IS COMPOSED OF MUST BE DISPOSED
ACCORDING TO THE DIRECTIVE 2002/96/CEE
APPLICABLE
EUROPEAN
DIRECTIVES
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:
73/23/CEE, for the approximation to the legislation of the Members States related to low
voltage equipment (and following modifications).
2004/108/CEE, for the approximation to the legislation of the Members States related to the
electromagnetic compatibility (and following modifications);
93/42/CEE, concerning the medical devices (and following modifications).
INTENDED USE
The product described in this manual is exclusively intended for the sterilization of solid and
hollow re-usable instruments and porous materials.
WARNING
THE DEVICE MUST ONLY BE USED BY QUALIFIED PERSONNEL. IT MAY
NOT BE USED OR HANDLED BY INEXPERT AND/OR UNAUTHORIZED
PERSONNEL FOR ANY REASON.
THIS DEVICE MUST NOT BE USED FOR THE STERILIZATION OF FLUIDS,
LIQUIDS OR PHARMACEUTICAL PRODUCTS.
NOTE
THE MANUAL INFORMATION ARE SUBJECT TO CHANGES WITHOUT ANY NOTICE.
MO.COM. LTD.CO.WON'T BE RESPONSIBLE FOR DIRECT,INDIRECT,ACCIDENTAL,
CONSEQUENT DAMAGES OR OTHER DAMAGES RELATED TO THE SUPPLY OR THE USE OF
SUCH INFORMATION.
THIS DOCUMENT MAY NOT BE REPRODUCED,ADAPTED OR TRANSLATED,IN WHOLE OR IN
PART,WITHOUT THE PRIOR,WRITTEN AUTHORIZATION OF M.O.COM. SRL
AND ARE REGISTERED TRADEMARKS OF M.O.COM. SRL

1. INTRODUCTION
2
PURPOSE OF THE
MANUAL The purpose of this manual is to provide instructions for:
– becoming generally familiar with the product;
– its correct installation and configuration;
– its safe, efficient use;
– handling materials before and after sterilization.
Its appendices also provide:
– the product's general technical specifications;
– sterilization program specifications;
– maintenance;
– troubleshooting;
– a variety of other documentation.
GENERAL
WARNINGS
When using this product, always follow the instructions in the manual and never use for
anything other than its intended purpose.
WARNING
THE USER IS RESPONSIBLE FOR ALL LEGAL REQUIREMENTS RELATED
TO THE INSTALLATION AND USE OF THIS PRODUCT. THE
MANUFACTURER 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 distilled water of high quality.
WARNING
THE USE OF WATER OF INADEQUATE QUALITY CAN SEVERELY
DAMAGE THE DEVICE.
SEE APPENDIX A, 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.
WARNING
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
TURNING 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
MANUFACTURER FROM ALL LIABILITY.

2. CONTENTS OF THE PACKAGE
3
CONTENTS OF
THE PACKAGE
DIMENSIONS
AND WEIGHT
Total weight about 75 kg
NOTE
CHECK THE INTEGRITY OF THE PACKAGE UPON
RECEIPT.
Once the package is opened, check that:
– the supply matches the specifications of the order (see the
accompanying document);
– that there is no obvious product damage;
NOTE
IN THE CASE OF A WRONG PRODUCT,MISSING PARTS OR ANY TYPE OF DAMAGE,
IMMEDIATELY PROVIDE A DETAILED DESCRIPTION TO THE RESELLER AND THE
TRANSPORTER THAT MADE THE DELIVERY.
DESCRIPTION OF
THE CONTENTS
The package contains:
– Steam sterilizer
– Stainless steel wire instrument tray (5 pcs.) (Ref. 1);
– Stainless steel wire tray support (Ref. 2);
– Instruction manual (Ref. 3);
– Warranty certificate (Ref. 4) (see note).
– Tray extractor (Ref. 5);
– Container with quick connector for adding distilled water (about 2 l ) (Ref. 6);
– Extra bacteriological filter (Ref. 7)
– Silicone tube (2 m) for draining water, with quick connector (Ref. 8).
– Spare roll of printer paper (Ref. 9).
NOTE
THE CUSTOMER MUST KEEP THE WARRANTY CERTIFICATE TOGETHER WITH THE
RECEIPT.
690
610
560

2. CONTENTS OF THE PACKAGE
4
HANDLING THE
PRODUCT
Where possible, the packaged product must be handled using suitable mechanical means
(forklift truck, transpallet, etc.) and following the instructions shown on the package.
In the case of manual handling, the product must be lifted by two persons using the handles
cut in the side of the box.
Once removed from the box, the sterilizer must be lifted by two persons and transported on a
cart or other similar device.
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 DAMAGE THE PRODUCT
DURING SHIPMENT.
DANGER
BEFORE TRANSPORT, LEAVE THE DEVICE TURNED-OFF FOR ABOUT 30
MINUTES AFTER THE LAST PROGRAM FINISHES AND DRAIN THE
DISTILLED WATER AND USED WATER TANKS SO THAT THE ALL THE
HOT INTERNAL PARTS WILL HAVE TIME TO COOL.

3. PRODUCT INTRODUCTION
5
PRODUCT
INTRODUCTION
INTRODUCTION
Millennium B² is MO.COM.'s revolutionary type B (EN 13060) small steam sterilizer and a
new de facto standard for 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.
GENERAL
CHARACTERISTICS Millennium B² is a completely microprocessor-controlled steam sterilizer with a large (21-
liter) sterilization chamber made of stamped stainless steel.
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
eliminating 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
excellent 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 11 sterilization programs (of which one completely programmable), 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.
Four of these can be selected directly from the control panel, which has a new simplified,
design.
And then, there are interesting options for configuring the preheating mode (based on the
sterilizer's frequency of use), printing the end of cycle report, methods for filling the water
supply, draining the used water and more.
Please refer to the chapter, “Configuration” for more detail.
Finally, Millennium B² has one of the most complete, sophisticated and advanced safety
systems available today to protect users in the case of any electrical, mechanical, thermal or
biological operating anomaly.
NOTE
PLEASE REFER TO APPENDIX A(TECHNICAL CHARACTERISTICS)FOR A DESCRIPTION
OF THE SAFETY DEVICES.